Abstract
Overdoses from non-medical use of opioids can lead to hypoxemic/hypercarbic respiratory failure, cardiac arrest, and death when left untreated. Opioid toxicity is readily reversed with naloxone, a competitive antagonist that can restore respiration. However, there remains a critical need for technologies to administer naloxone in the event of unwitnessed overdose events. We report a closed-loop wearable injector system that measures respiration and apneic motion associated with an opioid overdose event using a pair of on-body accelerometers, and administers naloxone subcutaneously upon detection of an apnea. Our proof-of-concept system has been evaluated in two environments: (i) an approved supervised injection facility (SIF) where people self-inject opioids under medical supervision and (ii) a hospital environment where we simulate opioid-induced apneas in healthy participants. In the SIF (n = 25), our system identified breathing rate and post-injection respiratory depression accurately when compared to a respiratory belt. In the hospital, our algorithm identified simulated apneic events and successfully injected participants with 1.2 mg of naloxone. Naloxone delivery was verified by intravenous blood draw post-injection for all participants. A closed-loop naloxone injector system has the potential to complement existing evidence-based harm reduction strategies and, in the absence of bystanders, help make opioid toxicity events functionally witnessed and in turn more likely to be successfully resuscitated.
Highlights
Overdoses from non-medical use of opioids can lead to hypoxemic/hypercarbic respiratory failure, cardiac arrest, and death when left untreated
Opioid overdose leads to death due to respiratory failure, which is characterized by respiratory depression and sedation, resulting in a hypoxemic/hypercarbic state[6]
Fatal drug overdoses in the United States are at an all time high, with over 81,000 such deaths recorded between May 2020–202126, and 70,630 such deaths recorded in 2019, prior to the COVID-19 pandemic[27]
Summary
Overdoses from non-medical use of opioids can lead to hypoxemic/hypercarbic respiratory failure, cardiac arrest, and death when left untreated. We report a closedloop wearable injector system that measures respiration and apneic motion associated with an opioid overdose event using a pair of on-body accelerometers, and administers naloxone subcutaneously upon detection of an apnea. We develop a proof-of-concept closed-loop, wearable naloxone injector system capable of administering naloxone in the setting of an apnea, prolonged apnea Building this system requires addressing a number of design and validation challenges. Our three-part solution comprises a detector element (a pair of on-body accelerometers that measure respiration and an onboard microcontroller that detects apneic motion), a commercially available wearable injection system that administers the drug subcutaneously and an actuator to activate the injector system in the presence
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