Polymer-Interface-Tissue Model to Estimate Leachable Release from Medical Devices.

The ability to predict clinically relevant exposure to potentially hazardous compounds that can leach from polymeric components can help reduce testing needed to evaluate the biocompatibility of medical devices. In this manuscript, we compare two physics-based exposure models: 1) a simple, one-component model that assumes the only barrier to leaching is the migration of the compound through the polymer matrix and 2) a more clinically relevant, two-component model that also considers partitioning across the polymer-tissue interface and migration in the tissue away from the interface. Using data from the literature, the variation of the model parameters with key material properties were established, enabling the models to be applied to a wide range of combinations of leachable compound, polymer matrix and tissue type. Exposure predictions based on the models suggest that the models are indistinguishable over much of the range of clinically relevant scenarios. However, for systems with low partitioning and/or slow tissue diffusion, the two-component model predicted up to three orders of magnitude less mass release over the same time period. Thus, despite the added complexity, in some scenarios it can be beneficial to use the two-component model to provide more clinically relevant estimates of exposure to leachable substances from implanted devices.