PMID- 35049719
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220124
IS  - 2306-5354 (Print)
IS  - 2306-5354 (Electronic)
IS  - 2306-5354 (Linking)
VI  - 9
IP  - 1
DP  - 2021 Dec 31
TI  - Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: 
      Analytical Model and Validation Strategy.
LID - 10.3390/bioengineering9010010 [doi]
LID - 10
AB  - 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.
FAU - Onken, Adrian
AU  - Onken A
AD  - Department of Engineering, Jade University of Applied Sciences, 26382 
      Wilhelmshaven, Germany.
AD  - Department of Otolaryngology, Hannover Medical School MHH, 30625 Hannover, 
      Germany.
FAU - Schutte, Helmut
AU  - Schutte H
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, 30625 Hannover, 
      Germany.
FAU - Lenz-Strauch, Heidi
AU  - Lenz-Strauch H
AD  - Department of Engineering, Jade University of Applied Sciences, 26382 
      Wilhelmshaven, Germany.
FAU - Kreienmeyer, Michaela
AU  - Kreienmeyer M
AD  - Department of Otolaryngology, Hannover Medical School MHH, 30625 Hannover, 
      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 - Stieglitz, Thomas
AU  - Stieglitz T
AUID- ORCID: 0000-0002-7349-4254
AD  - Department of Microsystems Engineering-IMTEK, University of Freiburg, 79110 
      Freiburg, Germany.
FAU - Gassmann, Stefan
AU  - Gassmann S
AD  - Department of Engineering, Jade University of Applied Sciences, 26382 
      Wilhelmshaven, Germany.
FAU - Lenarz, Thomas
AU  - Lenarz T
AUID- ORCID: 0000-0002-9307-5989
AD  - Department of Otolaryngology, Hannover Medical School MHH, 30625 Hannover, 
      Germany.
FAU - Doll, Theodor
AU  - Doll T
AD  - Department of Engineering, Jade University of Applied Sciences, 26382 
      Wilhelmshaven, Germany.
AD  - Department of Otolaryngology, Hannover Medical School MHH, 30625 Hannover, 
      Germany.
AD  - Institute of Polymer Chemistry, Johannes Kepler University, 4010 Linz, Austria.
AD  - Fraunhofer Institute of Toxicology and Experimental Medicine ITEM, 30625 
      Hannover, Germany.
LA  - eng
GR  - : 814654 - MDOT - H2020-NMBP-TO-IND-2018-2020/European Commission/
PT  - Journal Article
DEP - 20211231
PL  - Switzerland
TA  - Bioengineering (Basel)
JT  - Bioengineering (Basel, Switzerland)
JID - 101676056
PMC - PMC8773110
OTO - NOTNLM
OT  - AIMD
OT  - PDMS
OT  - body fluids
OT  - corrosion-triggered delamination
OT  - moving boundary diffusion
COIS- The authors declare no conflict of interest. The funders had no role in the 
      design of the study; in the collection, analyses, or interpretation of data; in 
      the writing of the manuscript, or in the decision to publish the results.
EDAT- 2022/01/21 06:00
MHDA- 2022/01/21 06:01
PMCR- 2021/12/31
CRDT- 2022/01/20 12:26
PHST- 2021/12/01 00:00 [received]
PHST- 2021/12/20 00:00 [revised]
PHST- 2021/12/25 00:00 [accepted]
PHST- 2022/01/20 12:26 [entrez]
PHST- 2022/01/21 06:00 [pubmed]
PHST- 2022/01/21 06:01 [medline]
PHST- 2021/12/31 00:00 [pmc-release]
AID - bioengineering9010010 [pii]
AID - bioengineering-09-00010 [pii]
AID - 10.3390/bioengineering9010010 [doi]
PST - epublish
SO  - Bioengineering (Basel). 2021 Dec 31;9(1):10. doi: 10.3390/bioengineering9010010.