Biostability and biocompatiblity of modified polyurethane elastomers

Several strategies have been employed to increase the biostability of medical grade polyurethanes while maintaining the desirable properties of current poly(ether urethanes). It was hypothesized that polyurethane surface chemistry controls biodegradation/biostability that can lead to ultimate failure/success of these materials in clinical applications. Chemical modification or replacement of the susceptible soft segment was evaluated as a design strategy to increase the biostability of medical grade polyurethanes. The effect of soft segment chemistry on the phase morphology, mechanical properties and in vivo response of commercial polyurethanes were compared.; Poly(ether urethane) (PEU), silicone-modified poly(ether urethane) (PEU-S), poly(carbonate urethane) (PCU) and silicone-modified poly(carbonate urethane) (PCU-S) elastomers were investigated. AFM phase imaging indicated that the overall two-phase morphology of poly(ether urethanes), necessary for its thermoplastic elastomeric properties, was not disrupted by changing the soft segment chemistry. All of the polyurethanes exhibited thermoplastic elastomeric behavior similar to that of the poly(ether urethane). Following material characterization, the biocompatibility of the polyurethane elastomers was evaluated using a subcutaneous cage implant protocol. All of the polyurethanes tested retained the excellent biocompatibility typical of poly(ether urethane) elastomers. Overall, the candidate polyurethanes were concluded to be suitable replacements of current poly(ether urethane) elastomers in medical applications.; The results from the cage implant study and cell culture experiments indicated that monocytes adhere, differentiate and fuse to form foreign body giant cells (FBGCs) on all of the polyurethane specimens. It is now generally accepted that the reactive oxygen species released by these adherent macrophages and FBGCs initiate PEU biodegradation. ATR-FTIR analysis of explanted samples provided evidence of chain scission and crosslinking in all of the polyurethane specimens. Therefore, it was concluded that the chosen soft segment modifications were insufficient to fully inhibit biodegradation. (Abstract shortened by UMI.)...