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 interfa...
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-12-01
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| Series: | Bioengineering |
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| Online Access: | https://www.mdpi.com/2306-5354/9/1/10 |
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| author | Adrian Onken Helmut Schütte Anika Wulff Heidi Lenz-Strauch Michaela Kreienmeyer Sabine Hild Thomas Stieglitz Stefan Gassmann Thomas Lenarz Theodor Doll |
| author_facet | Adrian Onken Helmut Schütte Anika Wulff Heidi Lenz-Strauch Michaela Kreienmeyer Sabine Hild Thomas Stieglitz Stefan Gassmann Thomas Lenarz Theodor Doll |
| author_sort | Adrian Onken |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T01:54:49Z |
| format | Article |
| id | doaj.art-3c78e0dd27c74e4e857a8bb0bfc3ddc2 |
| institution | Directory Open Access Journal |
| issn | 2306-5354 |
| language | English |
| last_indexed | 2024-03-10T01:54:49Z |
| publishDate | 2021-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Bioengineering |
| spelling | doaj.art-3c78e0dd27c74e4e857a8bb0bfc3ddc22023-11-23T12:59:01ZengMDPI AGBioengineering2306-53542021-12-01911010.3390/bioengineering9010010Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: Analytical Model and Validation StrategyAdrian Onken0Helmut Schütte1Anika Wulff2Heidi Lenz-Strauch3Michaela Kreienmeyer4Sabine Hild5Thomas Stieglitz6Stefan Gassmann7Thomas Lenarz8Theodor Doll9Department of Engineering, Jade University of Applied Sciences, 26382 Wilhelmshaven, GermanyDepartment of Engineering, Jade University of Applied Sciences, 26382 Wilhelmshaven, GermanyDepartment of Otolaryngology, Hannover Medical School MHH, 30625 Hannover, GermanyDepartment of Engineering, Jade University of Applied Sciences, 26382 Wilhelmshaven, GermanyDepartment of Otolaryngology, Hannover Medical School MHH, 30625 Hannover, GermanyInstitute of Polymer Chemistry, Johannes Kepler University, 4010 Linz, AustriaDepartment of Microsystems Engineering—IMTEK, University of Freiburg, 79110 Freiburg, GermanyDepartment of Engineering, Jade University of Applied Sciences, 26382 Wilhelmshaven, GermanyDepartment of Otolaryngology, Hannover Medical School MHH, 30625 Hannover, GermanyDepartment of Engineering, Jade University of Applied Sciences, 26382 Wilhelmshaven, GermanyThe 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.https://www.mdpi.com/2306-5354/9/1/10AIMDcorrosion-triggered delaminationPDMSmoving boundary diffusionbody fluids |
| spellingShingle | Adrian Onken Helmut Schütte Anika Wulff Heidi Lenz-Strauch Michaela Kreienmeyer Sabine Hild Thomas Stieglitz Stefan Gassmann Thomas Lenarz Theodor Doll Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: Analytical Model and Validation Strategy Bioengineering AIMD corrosion-triggered delamination PDMS moving boundary diffusion body fluids |
| title | Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: Analytical Model and Validation Strategy |
| title_full | Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: Analytical Model and Validation Strategy |
| title_fullStr | Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: Analytical Model and Validation Strategy |
| title_full_unstemmed | Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: Analytical Model and Validation Strategy |
| title_short | Predicting Corrosion Delamination Failure in Active Implantable Medical Devices: Analytical Model and Validation Strategy |
| title_sort | predicting corrosion delamination failure in active implantable medical devices analytical model and validation strategy |
| topic | AIMD corrosion-triggered delamination PDMS moving boundary diffusion body fluids |
| url | https://www.mdpi.com/2306-5354/9/1/10 |
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