Bone cement system for bone augmentation

摘要

A bone cement is provided that includes a solid component and a liquid component. The solid component and liquid component are mixed together to form the bone cement. After completion of the solid and liquid component mixing, the bone cement has an initial viscosity effective for manual application or manual injection onto or into a targeted anatomical location, e.g., bone, and the cement has stable viscosity range that over both time and temperature is effective for uniformly filling the targeted anatomical location, for example an osteoporotic bone or a fractured vertebral body, with minimal to no leakage of the cement from the targeted anatomical location. Additionally, both the initial viscosity and the stable viscosity of the bone cement are within a range that renders the bone cement effective for injection with a manually operated syringe or multiple syringes.

主权项

1. A bone cement formed by a combination of solid and liquid components comprising:
a solid component including a contrast agent, a polymerization initiator, a calcium phosphate based bone substitute material, and a solid polymer, wherein
the contrast agent is in a range of about 38 to about 42 percent by weight of the solid component,the polymerization initiator is in a range of about 0.3 to about 0.5 percent by weight of the solid component,the bone substitute material includes hydroxyapatite, in a range of about 14 to about 16 percent by weight of the solid component, andthe solid polymer comprises a mixture of poly(methylacrylate-co-methylmethacrylate) and poly(methylmethacrylate) in a range of about 43 to about 46 percent by weight of the solid component, wherein the poly(methylmethacrylate) is in the range of about 3 percent to about 15 percent by weight percent of the solid polymer, and a liquid component including a liquid monomer, a polymerization accelerator, and optionally, a polymerization inhibitor; wherein the bone cement has an initial injectable viscosity suitable for manual injection onto or into a targeted anatomical location, and wherein said initial injectable viscosity being formed substantially immediately after combining the solid component and liquid component.