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

Bioengineering

卷:9

Heidi Lenz-Strauch¹  Helmut Schütte¹  Adrian Onken¹  Stefan Gassmann¹  Theodor Doll¹  Thomas Stieglitz²  Michaela Kreienmeyer³  Anika Wulff³  Thomas Lenarz³  Sabine Hild⁴ 

[1] Department of Engineering, Jade University of Applied Sciences, 26382 Wilhelmshaven, Germany;

[2] Department of Microsystems Engineering—IMTEK, University of Freiburg, 79110 Freiburg, Germany;

[3] Department of Otolaryngology, Hannover Medical School MHH, 30625 Hannover, Germany;

[4] Institute of Polymer Chemistry, Johannes Kepler University, 4010 Linz, Austria;

关键词: AIMD;    corrosion-triggered delamination;    PDMS;    moving boundary diffusion;    body fluids;   

DOI  :  10.3390/bioengineering9010010

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown