FDA Scholar Program: Characterizing Leaching of Hazardous Material from Polymeric Biomaterials

Western Carolina University, Cullowhee NC

Investigators

Abstract

Potentially hazardous chemicals contained within implanted medical devices can pose a risk to human health if they migrate from the device into surrounding tissues. However, if the amount of chemicals released in one day is low, the exposure may have little to no risk of negative effects. Historically, the primary method to predict the amount of exposure has been through laboratory testing in chemical liquids. However, recent advances in science and computer technology support the development of new computer-based tools to predict exposure risk. In this research, mathematical equations and computer simulations are developed to predict how quickly potentially hazardous materials are released into the body. An advancement over previous simulations is the inclusion of both the medical device and the surrounding tissue in a two-component model designed to better predict exposure risk. Predictive models can reduce development cost, decrease animal testing, and enable products to reach the market faster without sacrificing public protection. Use of the model for preliminary risk assessment would be a great asset to industry, especially small companies that may lack the resources to predict outcomes prior to engagement with regulatory bodies. As an additional component, the principal investigator will visit medical device companies to share knowledge about the product evaluation process, develop a new course, and provide undergraduates with funded research opportunities. The goal of this research is to more accurately quantify the rate that leachable materials are released from a medical device by modeling their migration through a polymeric matrix and the contacting biological tissue. Research includes characterizing the transport properties of leachables in biological tissue by aggregating data from multiple sources and using cluster analysis to approximate transport properties of leachables in biological tissue. Mathematical models and computer simulations that utilize these transport properties will be created to predict migration of leachables using a diffusion-limited two-component system. In addition, a novel approach to model biomaterial systems will be developed that represent model parameters as probability density functions rather than single scalar values. This new approach will advance modeling tools available in this field. Overall, this research will improve the fundamental understanding of the fate of leachables contained within polymeric biomaterials in contact with the body. Physics-based models that better capture the complexities of this system will yield more clinically relevant results than extraction studies, expanding our understanding of these complex biodynamic systems. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.