Bone Cement Composition and Method of Making the Same

• US 20100086620A1
• Filed: 12/10/2009
• Published: 04/08/2010
• Est. Priority Date: 08/29/2005
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Meyer, Jörg, Wenz, Robert
• Granted Patent: US 9,089,625 B2
• Time in Patent Office: Days
• US Class Current: 424/602
• 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

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43. A kit 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, wherein the first component and second component are present in a weight ratio of about 2.2;

1 to about 3.3;

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44. The kit of claim 43, further comprising an apparatus suitable to mix the first and second components.

45. The kit of claim 43, further comprising an apparatus suitable to deliver a mixture of the first and second components to a surgical site.

46. The kit of claim 43, 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.

47. The kit of claim 46, wherein the imageable marker is selected from the group consisting of barium sulfate (BaS04), zirconium dioxide, CHI3, Na2FP03, and CaF2, and mixtures thereof.

48. The kit of claim 43, 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.

49. The kit of claim 48, wherein the admixture of proteins is selected from the group consisting of mitogenic growth factors, morphogenic growth factors, and mixtures thereof.

50. The kit of claim 48, wherein the drug is a bisphosphonate.

51. The kit of claim 43, wherein the radical donor is selected from the group consisting of benzoyl peroxide (BPO), azo-bis-isobutyrylnitrile (AIBN), and mixtures thereof.

52. The kit of claim 43, wherein the radical scavenger is selected from the group consisting of hydroquinone, hydroquinone monomethylether, vitamin E, and mixtures thereof.

53. The kit of claim 43, wherein the diluent is selected from the group consisting of polyethylene glycol (PEG), an ester of mellitic acid, and mixtures thereof.

54. The kit of claim 43, 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.