PMID- 37237696 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230530 IS - 2306-5354 (Print) IS - 2306-5354 (Electronic) IS - 2306-5354 (Linking) VI - 10 IP - 5 DP - 2023 May 22 TI - Computational Modeling of Diffusion-Based Delamination for Active Implantable Medical Devices. LID - 10.3390/bioengineering10050625 [doi] LID - 625 AB - 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((R)), 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. FAU - Nguyen, Minh-Hai AU - Nguyen MH AUID- ORCID: 0009-0009-4175-3002 AD - Department of Otolaryngology and Cluster of Excellence "Hearing4all", Hannover Medical School MHH, 30625 Hannover, Germany. AD - Department of Otolaryngology, Hannover Medical School MHH, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany. FAU - Onken, Adrian AU - Onken A AD - Department of Otolaryngology and Cluster of Excellence "Hearing4all", Hannover Medical School MHH, 30625 Hannover, Germany. AD - Department of Otolaryngology, Hannover Medical School MHH, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany. AD - Department of Engineering, Jade University of Applied Sciences, 26382 Wilhelmshaven, Germany. FAU - Wulff, Anika AU - Wulff A AD - Department of Otolaryngology, Hannover Medical School MHH, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany. FAU - Foremny, Katharina AU - Foremny K AD - Department of Otolaryngology, Hannover Medical School MHH, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany. FAU - Torgau, Patricia AU - Torgau P AD - Department of Otolaryngology, Hannover Medical School MHH, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany. FAU - Schutte, Helmut AU - Schutte H AD - Department of Engineering, Jade University of Applied Sciences, 26382 Wilhelmshaven, Germany. FAU - Hild, Sabine AU - Hild S AUID- ORCID: 0000-0001-6099-1924 AD - Institute of Polymer Chemistry, Johannes Kepler University, 4010 Linz, Austria. FAU - Doll, Theodor AU - Doll T AD - Department of Otolaryngology and Cluster of Excellence "Hearing4all", Hannover Medical School MHH, 30625 Hannover, Germany. AD - Department of Otolaryngology, Hannover Medical School MHH, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany. AD - Fraunhofer Institute of Toxicology and Experimental Medicine ITEM, 30625 Hannover, Germany. LA - eng GR - EXC2077/H4A/ GR - 814654/Medical Device Obligations Taskforce/ PT - Journal Article DEP - 20230522 PL - Switzerland TA - Bioengineering (Basel) JT - Bioengineering (Basel, Switzerland) JID - 101676056 PMC - PMC10215766 OTO - NOTNLM OT - COMSOL Multiphysics(R) OT - active implantable medical devices OT - cochlear implant OT - interface diffusion OT - lifetime prediction OT - moving boundary diffusion OT - volume diffusion COIS- The authors declare no conflict of interest. EDAT- 2023/05/27 09:43 MHDA- 2023/05/27 09:44 PMCR- 2023/05/22 CRDT- 2023/05/27 01:01 PHST- 2023/04/03 00:00 [received] PHST- 2023/05/05 00:00 [revised] PHST- 2023/05/12 00:00 [accepted] PHST- 2023/05/27 09:44 [medline] PHST- 2023/05/27 09:43 [pubmed] PHST- 2023/05/27 01:01 [entrez] PHST- 2023/05/22 00:00 [pmc-release] AID - bioengineering10050625 [pii] AID - bioengineering-10-00625 [pii] AID - 10.3390/bioengineering10050625 [doi] PST - epublish SO - Bioengineering (Basel). 2023 May 22;10(5):625. doi: 10.3390/bioengineering10050625.