A DEVICE TO REVERSE OPIOID OVERDOSE
With the U.S. still seeing record rates of opioid-related deaths, researchers from the Massachusetts Institute of Technology have developed an innovative way to reverse overdoses.
Written by Kayt Sukel
ACCORDING TO THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC), the number of opioid-related deaths has risen continuously for the past 25 years. Yet, despite the high rates of overdose—and the introduction of powerful, synthetic opioid drugs such as fentanyl—some states have reported a small decrease in opioid-related deaths. While the reasons are multifactorial, many experts believe that increased access to naloxone, an opioid antagonist drug that can be administered by injection or nasal spray to reverse overdose, should be given the lion’s share of the credit.
Unfortunately, it is still challenging to get hold of naloxone in many places. And far too often, the drug is administered too late in high-risk opioid users, said Giovanni Traverso, a gastroenterologist at Brigham and Women’s Hospital, as well as an associate professor of mechanical engineering at the Massachusetts Institute of Technology (MIT).
“There is a very clear unmet need with the continued opioid epidemic. Many folks who are at high risk of overdose recurrence may not have someone nearby who can intervene with naloxone,” he explained. “Given that context, we wanted to develop a system that can sense an overdose and then respond in a closed-loop manner.”
The device, which is about the size of a stick of gum, can be implanted under the skin, where it monitors heart rate, breathing rate, and other vital signs. When it determines that an overdose has occurred, it rapidly pumps out a dose of naloxone. Photo: MIT
The first step, Traverso said, was to gather data to understand the physiological symptoms of overdose in order to set up the right sensors in a potential device. It’s long been thought that when someone takes too much of an opioid, the drug slows and eventually stops respiration. But Traverso and colleagues did a deeper dive to understand what might be happening to other vital signs like heart rate.
“We learned there is a series of changes that occur in the body as a function of an overdose,” he said. “It’s not just breathing that stops. We discovered that when you combine signals, including that slowing of the respiratory rate, with changes in heart rate, you can better predict the onset of the overdose. This is critical because timing matters. You only have seconds to intervene.”
After developing an algorithm informed by the changes in vital signs, Traverso and colleagues then got to work on the physical device. Other research groups have attempted to design wearables in the past but have been thwarted by poor user adherence. To combat these issues, Traverso and colleagues worked diligently to design an implantable device, about the size of a USB stick, with the power to sense an oncoming overdose and automatically release 10 milligrams of naloxone into the body in response. In a recent study published in Device, the team demonstrated that the system reversed 96 percent of opioid overdoses in an animal model.
A new device, which can be implanted under the skin, rapidly releases naloxone to reverse an opioid overdose. Photo: MIT
“Trying to get all the sensors and systems to work together in this size and form factor was a challenge.”
Giovanni Traverso, associate professor of mechanical engineering, MIT
“Trying to get all the sensors and systems to work together in this size and form factor was a challenge,” he said. “It was so important to bring many disciplines together to come up with a good design: electronics, pharmaceutical science, mechanical engineers, medical device expertise, toxicology expertise, and animal experimentation expertise. That’s what got us to where we are now.”
But the device is not quite ready for human use. The researchers are continuing to refine their design and looking to the needs and preferences of potential end users to help them do it, Traverso said.
“We have some best estimates about the dose, size, location, and performance of this device,” he continued. “But, at the end of the day, we need to talk to the people who will be using this device, as well as prescribers, to understand what will be most helpful to all stakeholders. We plan to really engage with folks who are at high risk for overdose to understand their perspectives with respect to size, where in the body to place it, whether they want repeated dosing, or if they are amenable to going into the clinic to have the device charged.”
The team is currently working on making the device smaller, which involves creating custom chips and integrated circuits to miniaturize sensing and delivery. But the most important next step is understanding how generalizable the current study results are to the device’s use in human beings.
“There’s some work we can do with patients who are receiving some of these drugs in the operating room. They are controlled situations, not what you’d see with a real overdose, but it can help us see how these signals compare in the large mammal we really want to treat: the human,” Traverso said. “Once we get those results, we need to move on to manufacturing and scale-up, which will require engagement with further experts and funding.”
In the meantime, Traverso believes his team’s device design is a “critical first step” in addressing a widespread and deadly problem.
“Doing something like this takes a village with a diverse set of skills,” he said. “That’s critical when you are trying to address a major problem like this and move things forward. Working together, I believe we can help folks who are suffering from opioid addiction and reduce the number of overdoses that happen.”
Kayt Sukel is a technology writer and author in Houston.
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