scholarly journals Protective multilayer packaging for long-term implantable medical devices

2014 ◽  
Vol 255 ◽  
pp. 124-129 ◽  
Author(s):  
Andreas Hogg ◽  
Stefanie Uhl ◽  
François Feuvrier ◽  
Yann Girardet ◽  
Benjamin Graf ◽  
...  
Coatings ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. 579 ◽  
Author(s):  
Li ◽  
Cauwe ◽  
Yang ◽  
Schaubroeck ◽  
Mader ◽  
...  

Long-term packaging of miniaturized, flexible implantable medical devices is essential for the next generation of medical devices. Polymer materials that are biocompatible and flexible have attracted extensive interest for the packaging of implantable medical devices, however realizing these devices with long-term hermeticity up to several years remains a great challenge. Here, polyimide (PI) based hermetic encapsulation was greatly improved by atomic layer deposition (ALD) of a nanoscale-thin, biocompatible sandwich stack of HfO2/Al2O3/HfO2 (ALD-3) between two polyimide layers. A thin copper film covered with a PI/ALD-3/PI barrier maintained excellent electrochemical performance over 1028 days (2.8 years) during acceleration tests at 60 °C in phosphate buffered saline solution (PBS). This stability is equivalent to approximately 14 years at 37 °C. The coatings were monitored in situ through electrochemical impedance spectroscopy (EIS), were inspected by microscope, and were further analyzed using equivalent circuit modeling. The failure mode of ALD Al2O3, ALD-3, and PI soaking in PBS is discussed. Encapsulation using ultrathin ALD-3 combined with PI for the packaging of implantable medical devices is robust at the acceleration temperature condition for more than 2.8 years, showing that it has great potential as reliable packaging for long-term implantable devices.


2005 ◽  
Vol 58 (12) ◽  
pp. 845 ◽  
Author(s):  
Ramasri Mudumba ◽  
Ajay D. Padsalgikar ◽  
Stuart W. Littler

Elast-Eon polymers are a class of materials suitable for use in long-term implantable medical devices. They are the copolymers of methylene diphenyl diisocyanate (MDI) based polyurethanes and hydroxyl-terminated polydimethyl siloxane, and as a result combine the biostability and biocompatibility of silicones with the mechanical properties of polyurethanes. In order to ensure product safety and meet regulatory requirements, it is important to confirm the absence or presence of toxic 4,4′-methylene dianiline (MDA) in aqueous extracts of Elast-Eon. The present work focusses on the development of an analytical technique to detect any leachable MDA from Elast-Eon polymers. No traces of MDA could be detected in the aqueous extracts from Elast-Eon, or from sterilized and aged (accelerated oxidized) samples of Elast-Eon.


Coatings ◽  
2019 ◽  
Vol 10 (1) ◽  
pp. 19
Author(s):  
Changzheng Li ◽  
Maarten Cauwe ◽  
Lothar Mader ◽  
David Schaubroeck ◽  
Maaike Op de Beeck

Barrier layers for the long-term encapsulation of implantable medical devices play a crucial role in the devices’ performance and reliability. Typically, to understand the stability and predict the lifetime of barriers (therefore, the implantable devices), the device is subjected to accelerated testing at higher temperatures compared to its service parameters. Nevertheless, at high temperatures, reaction and degradation mechanisms might be different, resulting in false accelerated test results. In this study, the maximum valid temperatures for the accelerated testing of two barrier layers were investigated: atomic layer deposited (ALD) Al2O3 and stacked ALD HfO2/Al2O3/HfO2, hereinafter referred to as ALD-3. The in-house developed standard barrier performance test is based on continuous electrical resistance monitoring and microscopic inspection of Cu patterns covered with the barrier and immersed in phosphate buffered saline (PBS) at temperatures up to 95 °C. The results demonstrate the valid temperature window to perform temperature acceleration tests. In addition, the optimized ALD layer in combination with polyimide (polyimide/ALD-3/polyimide) works as effective barrier at 60 °C for 1215 days, suggesting the potential applicability to the encapsulation of long-term implants.


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