Newswise – A University of Washington research team has created a wearable device that can detect and reverse an overdose of opioids. The device is worn on the stomach as an insulin pump and detects when someone stops breathing or moves. It then injects naloxone to restore their respiration.
The results demonstrate the proof-of-concept of a wearable naloxone injector system, according to the paper published Nov. 22 in Scientific Reports. The opioid epidemic has grown worse since the pandemic, and has remained a major public-health crisis,” stated Justin Chan, a UW doctoral candidate in the Paul G. Allen school of Computer Science & Engineering. We have developed algorithms to automatically inject naloxone into a wearable injector that detects when the wearer stops breathing. “
Co-author Jacob Sunshine, an associate professor of anesthesiology and pain medicine at the UW School of Medicine, said one of the unique aspects of opioid overdoses is that naloxone, a benign drug, is highly effective and can save lives if it can be administered in a timely fashion.
The UW team wants to make these devices available widely, but first approval from the U.S. Food and Drug Administration is required. FDA has published special guidance regarding emergency-use injectors. This is part of an ongoing effort to speed up efforts to address this critical public safety problem.
In a multiyear collaboration with West Pharmaceutical Services, Penn, UW researchers developed a prototype that allows for safe medication administration. The research team used this injector system and sensors to develop an algorithm that detects the potentially life-threatening patterns of respirations caused by opioid poisoning.
Coauthor Shyam Gulkota, a UW Professor in the Allen School, stated that the device could be used to help people with different levels of opioid-use disorder and prevent accidental death.
” This wearable auto-injector could have the potential of reducing fatalities from opioid overdoses,” said he. We are optimistic that it will have a positive impact on the country’s suffering. “
The pilot device has a pair accelerometers to measure respiration, and an onboard processor to detect the halt in motion associated with breathing. The US regulatory approval for the wearable system has been granted. It activates the injector when there are prolonged apneic episodes.
The pilot device can also transmit data via Bluetooth about breathing rates and apneic movement to a nearby smartphone. To test the device, volunteers were enrolled in a clinical study in Vancouver, B.C. A parallel clinical trial was also conducted in a hospital setting with volunteers who showed signs of apnea while holding their breath. The researchers stated that the injection facility deployment was critical to develop breathing algorithms that use real-world opioid-induced changes.
The team recruited 25 participants at the Vancouver site. The sensors could accurately monitor the respiration rate of people suffering from opioid-use disorder. The device could also detect opioid-induced apnea (non-medical) which is a pattern of breathing that can lead to a fatal overdose. Vancouver’s testing did not include injection of naloxone. This was only done in order to develop the respiratory algorithm.
In the second study, 20 participants simulated overdose events in a hospital setting by breathing normally, then performing a breath hold for 15 seconds to mimic an apneic event. When the wearable system detected that the subject had not moved for at least 15 seconds, it activated and injected naloxone into the participant.
After the device was activated, blood samples were taken from participants to confirm that the system could inject the antidote in the circulatory system. This indicates the system’s potential to reverse opioid overdoses.
” We have enjoyed working with the UW researchers to bring together this expertise in cutting edge biosensing technology and wearable drug delivery technologies,” stated Alex Lyness (Senior Manager of Research and Technology at West Pharmaceuticals). “We are happy to have been able contribute to this project, which is aimed at solving a large unmet need. “
Researchers said further studies are needed to assess the comfort and discreteness of the device over longer time periods, particularly in unsupervised settings. They also stated that additional research is required to assess the effectiveness of naloxone injections in non-medical users. This research was funded by the National Science Foundation.
For more information, contact the team at [email protected].
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