| Summary: | Clinical studies suggest radiation dose and dose rate cause increased failure of medical implants however, little evidence supports this claim and due to the complexity of an in vivo environment, separating variable implants is difficult. Before beginning to understand material changes in vivo, a systematic study of silicone and polyurethane exposed to radiation is needed to verify whether radiation is a major variable contributing to material changes. This research fills a gap within the current literature by investigating low dose therapeutic radiation and varying dose rates at sterilization dose and answers questions on whether radiation in an aqueous environment alone is enough to significantly alter material properties. This is the first research to apply a water environment to therapeutic doses and the first to investigate a range of dose rates for clinical applications.
Biomedical grade silicone and polyurethane films will be exposed to both types of radiation in an aqueous environment separately and analyzed for changes. The limited current literature combined with standards for biomedical devices will be used to characterize changes seen in materials.
The first strategy used to explore the compliance of biomedical grade polymers employs low doses of therapeutic radiation ranging between 0 Gy and 80 Gy. Analysis of these low doses results in confirming cellular, mechanical and chemical stability of silicone and polyurethane. The second strategy used to investigate silicone and polyurethane exposed materials to 25 kGy (sterilization dose) of gamma irradiation at varying dose rates (3.2 - 833 Gy/min). Results from these studies conclude that varying the dose rate causes slight changes in both materials but not significant enough to alter bulk material properties.
In conclusion, the results from this research reveal that both silicone and polyurethane maintain their stability at low doses and varying dose rates of irradiation while in an aqueous environment. This indicates that increased failure rates seen in silicone and polyurethane materials in vivo when exposed to radiation cannot be contributed to radiation alone. With the highly complex environment medical devices are exposed to in vivo, each variable that may contribute to failure should be investigated individually before combining to fully understand the mechanisms of material failure. This study indicates that the environment may play a larger role in material change and there is a need for updates to medical device standards. === PHD
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