A revolutionary new implantable sensor may have the ability to reverse opioid overdoses by promptly releasing naloxone when an overdose is detected.
In 2023, opioid overdoses claimed the lives of over 100,000 Americans. The best-known method for treating an overdose is administering naloxone, but sometimes, first responders or bystanders are unable to reach the individual in time.
Researchers from MIT and Brigham and Women’s Hospital have created an innovative device designed to bridge that gap and potentially save lives during an overdose situation. Roughly the size of a piece of gum, this device can be implanted beneath the skin and continuously monitors vital signs such as heart rate and breathing rate. If it detects an overdose, it can quickly release a dose of naloxone.
A study published in the journal Device indicates that this device effectively reversed overdoses in animal subjects. The researchers anticipate that with further refinement, this approach could provide critical assistance to high-risk groups, particularly individuals who have previously survived an overdose.
“This could significantly address a major unmet need for individuals struggling with substance abuse and opioid dependency, particularly in high-risk populations,” comments Giovanni Traverso, an associate professor at MIT and a gastroenterologist at Brigham and Women’s Hospital, and the study’s senior author.
The lead authors of the paper include Hen-Wei Huang, a former visiting scientist at MIT, currently an assistant professor in Singapore; Peter Chai, an associate professor of emergency medicine at Brigham and Women’s Hospital; SeungHo Lee, a research scientist at MIT’s Koch Institute for Integrative Cancer Research; Tom Kerssemakers and Ali Imani, former master’s students at Brigham and Women’s Hospital; and Jack Chen, a doctoral mechanical engineering student at MIT.
An implantable device
Naloxone functions as an opioid antagonist, meaning it can latch onto opioid receptors and negate the effects of opioids like heroin and fentanyl. Typically delivered via injection or nasal spray, it can restore normal breathing within minutes.
However, many individuals experiencing an overdose find themselves alone and may lack timely help. Moreover, the surge of synthetic opioids has made overdose occurrences more abrupt and unpredictable. While some researchers are creating wearable devices to detect and administer naloxone during overdoses, none have yet demonstrated effectiveness. The MIT/BWH team opted for an implantable solution that minimizes bulkiness, facilitates direct naloxone injection into subcutaneous tissues, and removes the need for users to actively wear it.
The device they developed comes equipped with sensors that monitor heart rate, breathing rate, blood pressure, and oxygen levels. In their animal testing, the researchers recorded these signals to understand how they alter during a fentanyl overdose, leading to a unique algorithm for detecting overdoses with higher accuracy and differentiating them from other conditions that complicate breathing, like sleep apnea.
The findings revealed that fentanyl initially causes a drop in heart rate, shortly followed by a decrease in breathing. By tracking these changes, the researchers determined the optimal moment to activate naloxone delivery.
“One of the toughest challenges in creating an effective engineering solution to reduce overdose fatalities is addressing patient compliance, combating stigma, minimizing false alarms, and ensuring rapid antidote delivery,” explains Huang. “Our proposed solution aims to meet these needs through a compact robotic implant, featuring multi-sensing capabilities, continuous monitoring, autonomous decision-making, and an innovative micropumping system.”
The device also incorporates a small reservoir capable of storing up to 10 milligrams of naloxone. Upon overdose detection, it activates a pump that releases naloxone within approximately 10 seconds.
In their experiments with animals, the researchers found that this method reversed overdose effects successfully 96 percent of the time.
“We have designed a closed-loop system that can detect when an opiate overdose begins and then release the antidote, leading to recovery,” Traverso states.
Preventing overdoses
The research team envisions their technology helping those at the greatest risk of overdose, starting with individuals who have experienced overdoses in the past. They now aim to ensure the device is user-friendly, exploring the best implantation locations.
<p”A crucial aspect of tackling the opioid crisis is ensuring naloxone is available to individuals at critical risk times. We envision this device as part of a comprehensive harm-reduction approach, efficiently and safely administering naloxone to prevent overdose fatalities and offering support to individuals facing opioid use disorders,” emphasizes Chai.
The researchers aim to conduct human trials within the next three to five years and are currently focused on making the device smaller and improving the onboard battery, which now lasts about two weeks.
This research has been funded by Novo Nordisk, the McGraw Family Foundation at Brigham and Women’s Hospital, and MIT’s Department of Mechanical Engineering.
