IP Library Granted Patent US 9,364,582
Granted Patent B2
US 9,364,582 · App. 13/238,844 · Granted Jun 14, 2016

Malleable implants containing demineralized bone matrix

Inventors: Susan J. Drapeau (Cordova, TN); Kathy L. Remsen (Germantown, TN); William F. McKay (Memphis, TN); Nelson L. Scarborough (Germantown, TN)
Assignee: Warsaw Orthopedic, Inc.
A61L27/20A61F2/28A61L27/24A61L27/365A61L27/3608A61L27/48
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Quick Facts
Patent No.
US 9,364,582
App. No.
13/238,844
Granted
Jun 14, 2016
Kind
B2
Abstract

Described are malleable medical compositions such as pastes or putties that include solids combined with a liquid carrier. The solids can include particulate collagen and particulate demineralized bone matrix. The liquid carrier includes an aqueous medium comprising one or more polysaccharides. Also described are methods for making and using such medical compositions.

Claims (30)

1. A demineralized bone matrix (DBM) composition, comprising: bioresorbable solids admixed with a liquid carrier to form a malleable implant composition, said bioresorbable solids present at a level of 0.1 grams per cubic centimeter to 0.7 grams per cubic centimeter of said composition; said bioresorbable solids comprising a particulate solid collagen material and a particulate solid DBM material, said particulate solid collagen material present in a weight ratio no less than 1:12 and no greater than 1:2 relative to said particulate solid DBM material; and said liquid carrier comprising an aqueous gel of a biocompatible polysaccharide comprising an alginate having more than 50% alpha-L-guluronic acid, wherein said biocompatible polysaccharide is present at a level of 0.01 grams per cubic centimeter to 0.5 grams per cubic centimeter of said composition and comprises a viscosity from 25 mPas to 1000 mPas, and the particulate solid DBM material comprises at least 20 weight % of DBM particles having a maximum dimension of about 3 mm to about 5 mm and at least 20 weight % of DBM particles having a maximum dimension of less than 1 mm.

2. The composition of claim 1 , wherein said polysaccharide further comprises pectin and/or chitosan.

3. The composition of claim 1 , wherein said weight ratio is in the range of 1:12 to 1:5.

4. The composition of claim 1 , wherein said weight ratio is in the range of 1:10 to 1:5.

5. The composition of claim 1 , wherein: said bioresorbable solids are present at a level of about 0.1 g/cc to about 0.25 g/cc of said composition; said polysaccharide is present at a level of about 0.01 g/cc to about 0.03 g/cc of said composition; and said composition is a flowable paste.

6. The composition of claim 1 , wherein: said bioresorable solids are present at a level of about 0.2 g/cc to about 0.4 g/cc of said composition; said polysaccharide is present at a level of about 0.01 g/cc to about 0.5 g/cc of said composition; and said composition is a shape-retaining putty.

7. The composition of claim 5 , wherein said weight ratio of collagen material to DBM material is in the range of 1:10 to 1:5.

8. The composition of claim 6 , wherein said weight ratio of collagen material to DBM material is in the range of 1:10 to 1:5.

9. The composition of claim 1 , wherein said particulate solid collagen material comprises a chemically crosslinked collagen material.

10. The composition of claim 9 , wherein said particulate solid collagen material comprises a particulated sponge material.

11. The composition of claim 1 , also comprising a mineral material selected from synthetic ceramic granules or mineralized bone chips.

12. The composition of claim 1 , wherein said solid DBM material in said composition exhibits osteoinductivity.

13. A demineralized bone matrix (DBM) composition, comprising: a liquid carrier comprising an aqueous gel of a biocompatible polysaccharide comprising an alginate having more than 50% alpha-L-guluronic acid and a viscosity from 25 mPas to 1000 mPas, said aqueous gel in admixture with solids to form a malleable composition said solids comprising a chemically crosslinked, particulate collagen material; and said solids comprising a particulate DBM material, and the particulate DBM material comprises at least 20 weight % of DBM particles having a maximum dimension of about 3 mm to about 5 mm and at least 20 weight % of DBM particles having a maximum dimension of less than 1 mm.

14. The DBM composition of claim 13 , wherein said polysaccharide further comprises pectin and/or chitosan.

15. The DBM composition of claim 13 , wherein said particulate DBM material is osteoinductive.

16. The DBM composition of claim 15 , wherein the particulate collagen material comprises particulated sponge material having an average particle size of less than 2 mm.

17. The DBM composition of claim 13 , wherein said particulate collagen material is present in a weight ratio no less than 1:12 and no greater than 1:2 relative to said particulate DBM material.

18. The DBM composition of claim 17 , wherein said weight ratio of particulate collagen material to particulate DBM material is in the range of 1:10 to 1:5.

19. The DBM composition of claim 13 , wherein said solids are present at a level of about 0.1 g/cc to about 0.25 g/cc of said composition; said polysaccharide is present at a level of about 0.01 g/cc to about 0.03 g/cc of said composition; and said composition is a flowable paste.

20. The DBM composition of claim 13 , wherein: said solids are present at a level of about 0.2 g/cc to about 0.4 g/cc of said composition: said polysaccharide is present at a level of about 0.01 g/cc to about 0.5 g/cc of said composition; and said composition is a shape-retaining putty.

21. A demineralized bone matrix (DBM) composition, comprising: a liquid carrier comprising an aqueous gel including a biocompatible polysaccharide comprising an alginate having more than 50% alpha-L-guluronic acid and a viscosity from 25 mPas to 1000 mPas, said aqueous gel in admixture with particulate solids to form a malleable composition; said particulate solids comprising a particulated bioresorbable sponge material; and said particulate solids comprising a DBM material, and the DBM material comprises at least 20 weight % of DBM particles having a maximum dimension of about 3 mm to about 5 mm and at least 20 weight % of DBM particles having a maximum dimension of less than 1 mm.

22. The DBM composition of claim 21 , wherein said particulated bioresorbable sponge material comprises collagen.

23. The DBM composition of claim 21 , wherein said polysaccharide further comprises pectin and/or chitosan.

24. The DBM composition of claim 21 , wherein said sponge material is chemically crosslinked.

25. The DBM composition of claim 21 , wherein said DBM material is osteoinductive.

26. The composition of claim 1 , wherein said particulate solid DBM material further includes elongate particles having a width of at least 0.2 mm.

27. The DBM composition of claim 13 , wherein said particulate solid DBM material further includes elongate particles having a width of at least 0.2 mm.

28. The DBM composition of claim 21 , wherein said particulate solid DBM material further includes elongate particles having a width of at least 0.2 mm.

29. The composition of claim 1 , wherein the biocompatible polysaccharide has a molecular weight of about 2 to about 1000 kilodaltons.

30. The composition of claim 1 , wherein the alginate comprises sodium alginate and is present at a level of 0.065 grams per cubic centimeter of said composition, the collagen is present at a level of 0.043 grams per cubic centimeter of said composition, and the DBM is present at 0.267 grams per cubic centimeter of said composition.

Continuity (5)
Continuation 12043733 · Mar 6, 2008
Continuation In Part 11415037 · May 1, 2006
Continuation In Part 13238844
Continuation PCTUS2007067767 · Apr 30, 2007
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