A new moisture test for bionic devices has been developed by applied physicists. University of Sydney, Researchers are proposing new criteria for measuring water leakage to bioengineering devices such as pacemakers, cochlear implants, and retinal replacements.
Bionic implants need to function properly in the moist environment of the human body. Large leaks to the device can be easily detected during manufacturing, but small leaks can escape detection and require standard testing to ensure safety and prevent moisture failure.
Research team — Australian Research Council —The new moisture standards may give bionic implant wearers more confidence in the operation of life-changing devices, he said.
Professor David McKenzie of the University of Sydney’s Department of Physics said: “Accurate measurement of water penetration into medical devices is essential to ensure long-term performance.“ Accurate measurement requires accurate industry standards for assessing leak risk. ”
He said there are commercial systems for measuring relative humidity, but these are not sensitive enough for the most demanding applications of implantable biomedical devices. Using mass spectrometry technology to measure helium as a substitute for moisture leaks is the de facto industry standard test for serious small leaks that are difficult to pick up.
“In practice, helium testing of bioengineering devices is a good standard in most cases, but we believe that a 10-fold improvement in compliance can further guarantee the safety of biomedical implants.” Said Professor Mackenzie.
“Helium leak detection tests are widely used in more sensitive leak locations, but direct measurement of gas or liquid leaks at similar sensitivities has proven to be difficult. I will. “
Professor Mackenzie and colleagues at the National Institute of Measurement developed a standard leak test and showed how to use it to verify the quality of encapsulation and the containment of medical devices.The survey results are from the American Chemical Society Applied Materials & Interfaces..
Dr. Wenwenley, lead author of the National Institute of Measurements, said: “If the sensitivity is very high, it is important to measure the risk of water leakage directly, not the de facto measurement of helium.
“Water has a special ability to penetrate very small spaces, given its different behavior. For example, it was recently discovered that water acts in a very strange way within carbon nanotubes. In this case, the water does not seem to touch the sides of the small passages that are less than one millionth of human hair. “
“Such a’nano leak’will be very serious if it occurs in a medical device, especially one with many feedthrough openings, such as a bionic eye,” added Mackenzie.
Given their finding that water can leak up to 10 times faster than helium, researchers suggest that the compliance standards for helium testing in biomedical devices be increased by 10 times, or orders of magnitude. I am.
“As we improve bionic technology, wearable implants become more common, so it’s important to give people that extra level of security,” said Professor Mackenzie.
Study suggests new moisture standards for pacemakers and cochlear implants Source link Study suggests new moisture standards for pacemakers and cochlear implants