Computational Modeling of Diffusion-Based Delamination for Active Implantable Medical Devices.

Delamination at heterogeneous material interfaces is one of the most prominent failure modes in active implantable medical devices (AIMDs). A well-known example of an AIMD is the cochlear implant (CI). In mechanical engineering, a multitude of testing procedures are known whose data can be used for detailed modeling with respect to digital twins. Detailed, complex models for digital twins are still lacking in bioengineering since body fluid infiltration occurs both into the polymer substrate and along the metal-polymer interfaces. For a newly developed test for an AIMD or CI composed of silicone rubber and metal wiring or electrodes, a mathematical model of these mechanisms is presented. It provides a better understanding of the failure mechanisms in such devices and their validation against real-life data. The implementation utilizes COMSOL Multiphysics®, consisting of a volume diffusion part and models for interface diffusion (and delamination). For a set of experimental data, the necessary diffusion coefficient could be derived. A subsequent comparison of experimental and modeling results showed a good qualitative and functional match. The delamination model follows a mechanical approach. The results of the interface diffusion model, which follows a substance transport-based approach, show a very good approximation to the results of previous experiments.

Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: Analytical Model and Validation Strategy.

The ingress of body fluids or their constituents is one of the main causes of failure of active implantable medical devices (AIMDs). Progressive delamination takes its origin at the junctions where exposed electrodes and conductive pathways enter the implant interior. The description of this interface is considered challenging because electrochemically-diffusively coupled processes are involved. Furthermore, standard tests and specimens, with clearly defined 3-phase boundaries (body fluid-metal-polymer), are lacking. We focus on polymers as substrate and encapsulation and present a simple method to fabricate reliable test specimens with defined boundaries. By using silicone rubber as standard material in active implant encapsulation in combination with a metal surface, a corrosion-triggered delamination process was observed that can be universalised towards typical AIMD electrode materials. Copper was used instead of medical grade platinum since surface energies are comparable but corrosion occurs faster. The finding is that two processes are superimposed there: First, diffusion-limited chemical reactions at interfaces that undermine the layer adhesion. The second process is the influx of ions and body fluid components that leave the aqueous phase and migrate through the rubber to internal interfaces. The latter observation is new for active implants. Our mathematical description with a Stefan-model coupled to volume diffusion reproduces the experimental data in good agreement and lends itself to further generalisation.