The opioid crisis affects countless lives and kills more than 187 people every day, according to the Centers for Disease Control.
In 2023, more than 100,000 Americans died from opioid overdoses, and while drugs like Narcan — the brand name of a drug called naloxone — slowly become more accessible, this crisis will need further innovation to be defeated.
Researchers at MIT and Brigham and Women’s Hospital (the second-largest teaching hospital of Harvard University) have created a new device they hope will help to save more lives from opioid overdose.
It’s an implantable sensor — about the size of a stick of gum — that is placed under the skin, where it monitors variables like heart rate, breathing rate, and other vital signs of a patient. Researchers have named it the iSOS implant.
When it determines that an overdose has occurred, it rapidly administers a dose of naloxone.
Naloxone is an “opioid antagonist” which means it can bind to opioid receptors and block the effects of other opioids, like heroin and fentanyl.
Up until this point, the most effective way to save a life from an opioid overdose is for a first responder or bystander to immediately deliver naloxone — often in the form of Narcan nasal spray.
That said, responders can’t always reach a person in time. Overdoses can cause permanent brain damage in less than three minutes, and — heartbreakingly — death, within four to six minutes.
Additionally, the effects of naloxone wear off after about 30-45 minutes, so immediate action is vital to get someone the emergency help they need.
The iSOS sensor could close that gap and immediately reverse the effects of an overdose, buying people more time in an emergency.
In fact, in a new study published in the journal Device, the MIT and Harvard researchers found that the device could successfully reverse overdoses in animals.
Here’s how it works: Since vital signs like heart rate, blood pressure, oxygen saturation, and breathing rate all change rapidly in an overdose, the researchers were able to create a unique algorithm that measures these vitals.
This specific algorithm helps distinguish between other conditions, like sleep apnea, where breathing rates are also decreased.
By measuring how exactly these vitals change in an overdose, the researchers increased the sensitivity of the device to accurately detect an overdose and calculated the point at which naloxone should be administered.
The iSOS implant includes a refillable reserve that can pump 10 milligrams of naloxone into the deepest layer of the skin. The device can also buzz or send an alert to a smartphone to alert the patient of an overdose, or send a medical alert to first responders and loved ones.
In the animal trial, 96% of overdoses were successfully reversed using the iSOS.
Giovanni Traverso is an associate professor of mechanical engineering at MIT, a gastroenterologist at Brigham and Women’s Hospital, and the senior author of the new study.
“We created a closed-loop system that can sense the onset of the opiate overdose and then release the antidote, and then you see that recovery,” Traverso said in a statement.
While further testing must be done to reach clinical development, this approach could change the trajectory of the opioid crisis.
“This could really address a significant unmet need in the population that suffers from substance abuse and opiate dependency to help mitigate overdoses,” Traverso said, “with the initial focus on the high-risk population.”
That high-risk population includes folks living with substance use conditions who have already survived an overdose.
That said, the research team also knows that asking a patient to implant a device under their skin is a significant agreement.
“We believe that many patients would be willing to adopt the iSOS implant, especially those who are at high risk of opioid overdose and are seeking reliable, life-saving interventions,” Traverso told Cosmos.
“However, we also recognize that the decision to adopt an implantable device is significant, and acceptance may vary among individuals.”
The device has taken about five years thus far to develop, and, according to Traverso, has a timeline of initiating first-in-human trials within the next three to five years.
In the future, he also said the research team plans to run surveys, focus groups, and pilot programs to better understand patients’ and healthcare providers’ opinions on the iSOS.
Hen-Wei Huang, a former MIT visiting scientist and current engineering professor at Nanyang Technological University in Singapore, agreed that the implementation of this device is not without its hurdles.
“The most challenging aspect of developing an engineering solution to prevent overdose mortality is simultaneously addressing patient adherence and willingness to adopt new technology, combating stigma, minimizing false positive detections, and ensuring the rapid delivery of antidotes,” Huang explained.
But, while other wearable devices have been studied for this same issue, the iSOS is one of the first to show such remarkable promise.
“Our proposed solution tackles these unmet needs by developing a miniaturized robotic implant equipped with multi-sensing modalities, continuous monitoring capabilities, on-board decision making, and an innovative micro-pumping mechanism,” Huang added.
It’s not yet clear when the iSOS will be implemented in a clinical setting, or how exactly it will be administered, but the researchers are eager to see it become part of the tool belt in confronting the opioid epidemic.
“A key pillar of addressing the opioid epidemic is providing naloxone to individuals at key moments of risk,” said Peter Chai, an associate professor of emergency medicine physician at Brigham and Women’s Hospital.
“Our vision for this device is for it to integrate into the cascade of harm-reduction strategies to efficiently and safely deliver naloxone, preventing death from opioid overdose and providing the opportunity to support individuals with opioid use disorder.”
Header image courtesy of MIT
