Polymer-interface-tissue model to estimate leachable release from medical devices.

Abstract

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