BONE CEMENT COMPOSITION AND METHOD

• US 20090264554A1
• Filed: 04/22/2008
• Published: 10/22/2009
• Est. Priority Date: 04/22/2008
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc), Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: MEYER, Jorg, WENZ, Robert
• Granted Patent: US 7,968,616 B2
• Time in Patent Office: Days
• US Class Current: 523/116
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/44 Radioisotopes, radionuclides
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/043 Mixtures of macromolecular materials
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: C08L 33/12 Homopolymers or copolymers of methyl methacrylate

Abstract

The disclosure is directed to a composition includes a first component and a second component. The first component includes a poly(methyl methacrylate) (PMMA), a contrast agent, and a radical donor. The second component includes methyl methacrylate (MMA), a radical scavenger, and a polymerization accelerator. The composition has an average setting time of about 13 minutes. The disclosure is further directed to a kit and a method of making the above-mentioned composition.

Claims

1. A composition comprising:

a) a first component comprising a poly(methyl methacrylate) (PMMA), a contrast agent, and a radical donor; and

b) a second component comprising methyl methacrylate (MMA), a radical scavenger, and a polymerization accelerator;

wherein the composition has an average setting time of about 13 minutes.

2. The composition of claim 1, wherein the composition is substantially free of hydroxyapatite.

3. The composition of claim 1, wherein the PMMA has an average particle size of about 35 microns to about 60 microns.

4. The composition of claim 1, wherein the PMMA has a molecular weight of about 200,000 grams/mole to about 500,000 grams/mole.

5. The composition of claim 1, wherein the contrast agent is present at not less than about 20% by weight of the total weight of the first component.

6. The composition of claim 5, wherein the contrast agent is present at about 30% by weight to about 35% by weight of the total weight of the first component.

7. The composition of claim 1, wherein the contrast agent is selected from the group consisting of barium sulfate (BaSO₄), zirconium dioxide, CHI₃, Na₂FPO₃, and CaF₂, and mixtures thereof.

8. The composition of claim 7, wherein the contrast agent has an average particle size of about 0.3 microns to about 10 microns.

9. The composition of claim 8, wherein the contrast agent has an average particle size of about 0.3 microns to about 2.0 microns.

10. The composition of claim 1, wherein the radical donor is selected from the group consisting of benzoyl peroxide (BPO), azo-bis-isobutyrylnitrile (AIBN), and mixtures thereof.

11. The composition of claim 10, wherein the radical donor is present at about 1.5% by weight to about 2.0% by weight of the total weight of the second component.

12. The composition of claim 1, wherein the radical scavenger is selected from the group consisting of hydroquinone monomethylether, hydroquinone, vitamin E, and mixtures thereof.

13. The composition of claim 1, wherein the polymerization accelerator is selected from the group consisting of dimethylparatoluidine (DMPT), dihydroxyethylorthotoluidine, and mixtures thereof.

14. The composition of claim 13, wherein the polymerization accelerator is present at about 0.2% by weight to about 1.0% by weight of the total weight of the second component.

15. The composition of claim 14, wherein the polymerization accelerator is present at about 0.2% by weight to about 0.5% by weight of the total weight of the second component.

16. The composition of claim 1, wherein the composition has a setting time of about 9 minutes.

17. The composition of claim 1, further comprising an optional ingredient selected from the group consisting of an antibiotic, a cytostatic agent, an analgesic agent, a disinfectant, a preservative, a growth factor, a proliferative factor, a protein, a peptide, a biopolymer, a dye, a chemotherapeutic, a drug, and mixtures thereof.

18. The composition of claim 1, having a viscosity of about 500 Pascal-second at a time of greater than about 3:

15 minutes.

19. A kit comprising:

a) a packaged first component comprising a poly(methyl methacrylate) (PMMA), a radical donor and a contrast agent; and

b) a second packaged component comprising methyl methacrylate (MMA), a radical scavenger, and a polymerization accelerator;

wherein the mixed first component and second component has an average setting time of about 13 minutes.

20. A method of making a bone cement composition comprising:

a) mixing a first component and a second component,

the first component comprising a poly(methyl methacrylate) (PMMA), a radical donor and a contrast agent;

the second component comprising methyl methacrylate (MMA), a radical scavenger, and a polymerization accelerator; and

b) providing a set bone cement composition after an average time of about 13 minutes.