Bone cement composition and method of making the same

• US 9,089,625 B2
• Filed: 12/10/2009
• Issued: 07/28/2015
• Est. Priority Date: 08/29/2005
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon SARL (Medtronic Plc)
• Inventors: Wenz, Robert, Meyer, Jrg
• Primary Examiner(s): SINGH, SATYENDRA K
• Application Number:
  US12/635,095
• Publication Number:
  US 20100086620A1
• Time in Patent Office: 2,056 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/66 Phosphorus compounds
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61L 24/0084 containing fillers of phosphorus-containing inorganic compounds, e.g. apatite
• CPC Class Codes: A61L 24/04 containing macromolecular materials
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease

Abstract

Disclosed herein is a composition suitable for use in spinal surgery. The composition generally includes a reaction product or settable mixture of first and second components, the first component including a spray-dried inorganic filler, a radical donor, and a pre-polymerized vinyl polymer, and the second component including a radical scavenger, a diluent, a polymerization accelerator, and a reactive monomer. Furthermore, disclosed herein is a method of making the composition, which generally includes mixing the first and second components under conditions suitable to form a curable reaction product.

Claims

1. A kit for bone cement comprising:

a first component comprising a spray-dried hydroxyapatite, a radical donor and poly(methyl methacrylate) (PMMA), wherein the spray-dried hydroxyapatite is present at about 30 wt. % to about 99.5 wt. %, based on the total weight of the first component and has a particle size of about 20 micrometers to about 35 micrometers; and

a second component comprising a radical scavenger, a diluent, a polymerization accelerator, and a reactive monomer of methyl methacrylate (MMA),

wherein the reactive monomer of MMA comprises about 40 wt. % to about 95 wt. % of the second component,

wherein the first component and second component in the bone cement are present in a weight ratio of about 2.2;

1 to about 3.3;

1.

2. The kit of claim 1, further comprising an apparatus suitable to mix the first and second components.

3. The kit of claim 1, further comprising an apparatus suitable to deliver a mixture of the first and second components to a surgical site.

4. The kit of claim 1, wherein the first component further comprises 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, an imageable marker, a dye, and mixtures thereof.

5. The kit of claim 4, wherein the imageable marker is selected from the group consisting of barium sulfate (BaS0₄, zirconium dioxide, CHI₃, Na₂FP0₃, and CaF₂, and mixtures thereof.

6. The kit of claim 1, wherein the second component further comprises an optional ingredient selected from the group consisting of a dye, an admixture of proteins, a chemotherapeutic, a drug, an antibiotic, and mixtures thereof.

7. The kit of claim 6, wherein the admixture of proteins is selected from the group consisting of mitogenic growth factors, morphogenic growth factors, and mixtures thereof.

8. The kit of claim 6, wherein the drug is a bisphosphonate.

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

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

11. The kit of claim 1, wherein the diluent is selected from the group consisting of polyethylene glycol (PEG), an ester of mellitic acid, and mixtures thereof.

12. The kit of claim 1, wherein the first component comprises about 0.5 wt. % to about 5 wt. % of the radical donor, based on the total weight of the spray-dried hydroxyapatite and the PMMA.

13. The kit of claim 1, wherein the first component comprises an imageable marker that comprises up to 30 wt. % of the first component, based on the total weight of the first component.

14. The kit of claim 1, wherein the first component comprises an imageable marker that comprises up to 10 wt. % of the first component, based on the total weight of the first component.

15. The kit of claim 1, wherein the diluent is polyethylene glycol (PEG) having a molecular weight of about 800 D.

16. The kit of claim 1, wherein the first component comprises about 30 wt. % of PMMA based on the total weight of the first component.

17. The kit of claim 1, wherein the radical scavenger comprises about 30 parts per million to about 400 parts per million of the second component.

18. The kit of claim 1, wherein the spray-dried hydroxyapatite has a surface area of 0.8 m²/g.

19. A kit for bone cement comprising:

a first component comprising a spray-dried hydroxyapatite, benzoyl peroxide (BPO), barium sulfate (BaS0₄) and poly(methyl methacrylate) (PMMA), wherein the spray-dried hydroxyapatite is present at about 30 wt. % to about 99.5 wt. %, based on the total weight of the first component and has a particle size of about 20 micrometers to about 35 micrometers; and

a second component comprising hydroquinone monomethylether, a diluent, dimethylparatoluidine (DMPT), and a reactive monomer of methyl methacrylate (MMA),

wherein the reactive monomer of MMA comprises about 60 wt. % to about 90 wt. % of the second component,

wherein the first component and second component in the bone cement are present in a weight ratio of about 2.2;

1 to about 3.3;

1.

20. A kit for bone cement comprising:

a first component comprising a spray-dried hydroxyapatite, a radical donor and poly(methyl methacrylate) (PMMA), wherein the spray-dried hydroxyapatite is present at about 30 wt. % to about 99.5 wt. % based on the total weight of the first component and has a particle size of about 20 micrometers to about 35 micrometers; and

a second component comprising a radical scavenger, a diluent, a polymerization accelerator, and a reactive monomer of methyl methacrylate (MMA),

wherein the first component and second component in the bone cement are present in a weight ratio of about 2.2;

1 to about 3.3;

1.