Bone void fillers

• US 8,613,938 B2
• Filed: 11/15/2011
• Issued: 12/24/2013
• Est. Priority Date: 11/15/2010
• Status: Active Grant

• Current Assignee: Zimmer Orthobiologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Orthobiologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Akella, Rama, Garrett, Ian Ross, Wen, Hai Bo, Li, Shuliang, Acker, Dean M., Wilhelm, Nichole
• Primary Examiner(s): Sasan, Aradhana
• Application Number:
  US13/297,005
• Publication Number:
  US 20120121660A1
• Time in Patent Office: 770 Days
• Field of Search: 424/400, 424/549
• US Class Current: 424/400
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 24/0063 Phosphorus containing materials, e.g. apatite
• CPC Class Codes: A61L 24/0084 containing fillers of phosphorus-containing inorganic compounds, e.g. apatite
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

A bone void filler composition is described containing an acidic mineral component that contains a calcium source and a phosphate source or a lower alkyl carboxylate source; an osteoinductive component that contains demineralized bone; and a three-dimensional, osteoconductive biologically acceptable carrier component that contains a collagenous material. The bone void filler composition may be in the form of a sponge or in the form of a paste or putty used to form a sponge or is obtained from particulated sponge, or that forms after a sponge is rehydrated. A pre-mixed bone void filler composition is described containing the acidic mineral component or the lower alkyl carboxylate source; the osteoinductive component; and a biologically acceptable carrier component that contains a liquid carrier. Methods of making and using the compositions are also described. The ratio of demineralized bone component to acidic mineral component may range from about 0.5:1 to about 80:1.

Claims

1. A bone void filler composition comprising:

an acidic calcium phosphate component from about 8 wt % to about 12 wt % of the composition;

an osteoinductive demineralized bone component from about 70 wt % to about 80 wt % of the composition; and

an osteoconductive collagen carrier component from about 10 wt % to about 16 wt % of the composition;

wherein the composition is in the form of a porous three dimensional structure; and

wherein the composition has a pH from about 3 to about 5;

with the proviso that the acidic calcium phosphate component is not Ca₃(PO₄)2H₂O.

2. The bone void filler composition of claim 1, wherein the acidic calcium phosphate component comprises monocalcium phosphate monohydrate [Ca(H₂PO₄)2H₂O];

calcium hydrogen phosphate dihydrate [CaHPO₄2H₂O], anhydrous calcium hydrogen phosphate [CaHPO₄], partially dehydrated calcium hydrogen phosphate [CaHPO₄xH₂O, where x is between 0 and 2], and/or calcium pyrophosphate (Ca₂O₇P₂) [2CaO₂P₂O₅].

3. The bone void filler composition of claim 2, wherein the acidic calcium phosphate component comprises anhydrous calcium hydrogen phosphate [CaHPO₄], partially dehydrated calcium hydrogen phosphate [CaHPO₄xH₂O, where x is between 0 and 2], and/or calcium hydrogen phosphate dihydrate [CaHPO₄2H₂O].

4. The bone void filler composition of claim 1, further comprising an additive selected from the group consisting of allograft chips, bioceramics, biocomposites, calcium salts other than the acidic calcium phosphate component, phosphate salts other than the acidic calcium phosphate component;

and combinations thereof.

5. The bone void filler composition of claim 1, further comprising an additive selected from the group consisting of bioresorbable fibers, synthetic polymers, and combinations thereof.

6. The bone void filler composition of claim 1, wherein the demineralized bone is in a form selected from a powder, particle, granule, fiber, and combinations thereof.

7. The bone void filler composition of claim 6, wherein the demineralized bone is in a form selected from a particle, granule, and combinations thereof.

8. The bone void filler composition of claim 7, wherein the demineralized bone particle or granule size is from about 105 μ

m to about 850 μ

m.

9. The bone void filler composition of claim 1, wherein the demineralized bone component is derived from a human donor.

10. The bone void filler composition of claim 1, wherein the osteoconductive collagen carrier component comprises collagen from a non-human mammal.

11. The bone void filler composition of claim 10, wherein the osteoconductive collagen carrier component comprises bovine collagen.

12. The bone void filler composition of claim 10, wherein the osteoconductive collagen component comprises Type I and/or Type III collagen.

13. The bone void filler composition of claim 12, wherein the osteoconductive collagen component comprises more than about 90 wt % Type I and less than about 10 wt % Type III collagen.

14. The bone void filler composition of claim 1, further comprising a liquid carrier selected from selected from the group consisting of i) biological fluids selected from the group consisting of bone marrow aspirate, whole blood, serum, and/or plasma, ii) biocompatible liquids selected from the group consisting of water, saline and/or aqueous buffers, and iii) combinations of i) and ii).

15. The bone void filler composition of claim 14, wherein the liquid carrier comprises bone marrow aspirate and saline.

16. The bone void filler composition of claim 1, which is lyophilized.

17. The bone void filler composition of claim 1, wherein the porous three dimensional structure is in the form of a strip, disc, sheet, bullet or cylinder.

18. The bone void filler composition of claim 1, wherein the porous three dimensional structure is shaped for dental ridge augmentation.