Quantifying Moisture Penetration in Encapsulated Devices by Heavy Water Mass Spectrometry: A Standard Moisture Leak Using Poly(ether-ether-ketone)

Moisture penetration into active biomedical implants such as the bionic ear and eye is a major problem in healthcare since surgery is required to replace devices affected by corrosion. Existing methods for measuring moisture leak rates such as the commercially available dynamic relative humidity method are not sufficiently sensitive to guarantee security against moisture penetration. Helium leak detection is highly sensitive but is challenged by the unknown relation to the moisture leak rate because of mixed flow modes involving liquid water. A standard moisture leak traceable to fundamental units is not currently available, preventing direct comparison of moisture and helium leak rates in the same device. Here, we demonstrate a practical calibrated moisture leak based on the stable polymer poly(ether-ether-ketone), for calibrating heavy water mass spectrometry. Using biomedical test structures from manufactured encapsulations, we show that in the majority of cases, calibrated measurements of molar moisture leak rates exceed the helium leak rate, especially for very small and large leaks. Comparison with theory shows that LaPlace pressure is the driving force for the enhanced moisture flows. We recommend that the compliance limit for helium testing in biomedical devices be reduced by one order of magnitude.

Automated summary

The current methods are not sensitive enough to prevent moisture penetration, we propose using poly(ether-ether-ketone) to calibrate moisture leak rates and find that in most cases, the calibrated moisture leak rate exceeds the helium leak rate, recommending a reduction of one order of magnitude in the compliance limit for helium testing in biomedical devices.