Composite bone graft substitute cement and articles produced therefrom

A bone graft substitute kit, comprising:

• i) a multi-chambered vial comprising a first chamber containing monocalcium phosphate monohydrate powder and a second chamber containing a mixture of β-tricalcium phosphate powder, calcium sulfate hemihydrate powder, calcium sulfate dihydrate powder, and β-tricalcium phosphate granules, the vial further comprising a cap that encloses the first and second chambers;
• ii) a vacuum mixing apparatus operatively adapted for mixing powder and liquid components to form a homogenous composition;
• and
• iii) a reconstitution device comprising a first vial having a first penetrable closure and containing an aqueous solution, a second vial having a second penetrable closure and containing a glycolic acid powder in neutralized salt form, and a coupling assembly operatively adapted for piercing the first and second penetrable closures in order to place the first vial and the second vial in fluid communication such that the glycolic acid powder can be reconstituted into an aqueous neutralized glycolic acid solution.

A method of preparing a bone graft substitute composition, comprising:

• i) providing a reconstitution device comprising a first vial having a first penetrable closure and containing an aqueous solution, a second vial having a second penetrable closure and containing a carboxylic acid powder, and a coupling assembly operatively adapted for piercing the first and second penetrable closures in order to place the first vial and the second vial in fluid communication;
• ii) mixing the aqueous solution with the carboxylic acid powder to form a reconstituted carboxylic acid solution, the mixing step comprising placing the first vial and second vial in fluid communication;
• iii) providing at least one powder material comprising a calcium sulfate or a calcium phosphate compound, wherein the powder material comprises a first powder material and a second powder material enclosed within a multi-chambered vial, the vial comprising a first chamber containing the first powder material and a second chamber containing the second powder material, the vial further comprising a cap enclosing the first and second chambers;
• iv) pouring the at least one powder material into a mixing container of a mixing apparatus operatively adapted for mixing powder and liquid components to form a homogenous composition;
• v) pouring the reconstituted carboxylic acid solution into the mixing container of the mixing apparatus;
• vi) mixing the reconstituted carboxylic acid solution with the powder material in the mixing apparatus until a homogenous bone graft substitute composition is formed;
• and
• vii) extruding the bone graft substitute composition into a syringe.