Inventors:
Melissa Knothe Tate - Cleveland Heights OH, US
Ulf Knothe - Cleveland Heights OH, US
International Classification:
A61F002/28, C12N005/08
US Classification:
623023500, 623023510, 623023760, 623023360, 606077000, 435396000
Abstract:
A composition and method for inducing bone growth and healing is provided. The composition is useful for promoting new bone synthesis, and to enhance the mechanical stability and longevity of orthopaedic implants. The composition includes a bone endogenous material which is used as raw material for the body's natural osteogenic mechanism to synthesize new bone. The composition has a flow phase and a congealed phase. The composition is applied, in the flow phase, within the reamed medullary canal of a long bone prior to insertion of an endoprosthesis. Following insertion of the endoprosthesis, the composition undergoes a phase change to the congealed phase, for example via cross-linking of the bone endogenous material in the composition, to provide a compliant barrier layer in the intra-medullary gap between the implanted endoprosthesis and the medullary canal wall. The resulting barrier layer has a dual mode porosity system, having a first order porosity to accommodate and promote convective diffusion of nutrient species into and through the barrier layer, and a second order porosity to accommodate osteoblastic migration therein without the need for osteoclastic resorption. Osteoblasts synthesize new bone using the barrier layer itself as raw material, essentially osteoconverting the barrier layer into synthesized new bone. In a preferred embodiment, the second order porosity is provided via a rapidly degrading polymer added to the composition, which has a half-life for degradation of 1-60 days.