The Development and Characterization of a Primarily Mineral Calcium Phosphate - Poly(ε-caprolactone) Biocomposite
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Orthopaedic reconstruction often involves the surgical introduction of structural implants that provide for rigid fixation, skeletal stabilization, and bone integration. The high stresses incurred by these implanted devices have historically limited material choices to metallic and select polymeric formulations. While mechanical requirements are achieved, these non-degradable materials do not participate actively in the remodeling of the skeleton and present the possibility of long-term failure or rejection. This is particularly relevant in cervical fusion, an orthopaedic procedure to treat damaged, degenerative or diseased intervertebral discs. A significant improvement on the available synthetic bone replacement/regeneration options for implants to treat these conditions in the cervical spine may be achieved with the development of primarily mineral biocomposites comprised of a bioactive ceramic matrix reinforced with a biodegradable polymer. Such a biocomposite may be engineered to possess the clinically required mechanical properties of a particular application, while maintaining the ability to be remodeled completely by the body. A biocomposite of Si-doped calcium phosphate (Si-CaP) and poly(ε-caprolactone) (PCL) was developed for application as such a synthetic bone material for potential use as a fusion device in the cervical spine. In this thesis, a method by which high mineral content Si-CaP/PCL biocomposites with interpenetrating matrices of mineral and polymer phases may be prepared will be demonstrated, in addition to the effects of the various preparation parameters on the biocomposite density, porosity and mechanical properties. This new technique by which dense, primarily ceramic Si-CaP/PCL biocomposites were prepared, allowed for the incorporation of mineral contents ranging between 45-97vol%. Polymer infiltration, accomplished solely by passive capillary uptake over several days, was found to be capable of fully infiltrating the microporosity of the sintered calcium phosphate ceramic. After infiltration, these biocomposite materials demonstrated an increase in compressive strength, flexural strength and Young’s modulus with increasing ceramic content and met design targets for use as a cervical fusion prosthesis. The biocomposite was amenable to shaping and drilling and was found to maintain its strength after 30 days immersion in Earle’s Balanced Salt.