In preclinical models, the subcutaneously implanted device continuously monitored vital signs and automatically and rapidly delivered naloxone when it detected an opioid overdose.
The opioid epidemic continues to have devastating effects in the United States, exacerbated by the increasing presence of fentanyl in illicit opioids. Naloxone is an effective antidote, but it usually needs to be administered quickly by a bystander. Now, researchers at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, and MIT have developed an implantable device to detect and reverse opioid overdoses. The device, which they call “iSOS,” continuously monitors the heart and respiratory systems for signs of overdose and automatically delivers naloxone when needed. In preclinical studies, iSOS was effective at detecting and reversing opioid overdoses. The study was published in the journal Device.
“Naloxone saves lives, but is often not administered in a timely manner,” said co-first author Peter Ray Chai, MD, MS, Division of Emergency Medicine at Brigham and Women’s Hospital. “The iSOS device offers a highly innovative strategy for detecting opioid overdose and enables the precise administration of naloxone at the moment of need. This will hopefully prevent individuals from overdosing and facilitate continued recovery from opioid use disorder.”
When an overdose occurs, people generally lose consciousness. An automated naloxone delivery system could therefore save the lives of people who take opioids alone.
“In overdoses, a nearby bystander can be rescued by intramuscular or intranasal administration of naloxone, but that bystander is required. We wanted to find a way to do this in an autonomous manner,” said corresponding author Giovanni Traverso, MB, PhD, MBBCH, Department of Medicine at Brigham and Women’s Hospital and MIT.
To eliminate the need for bystander intervention, the researchers wanted to develop a closed-loop system that could both detect an opioid overdose and administer the drug without external guidance. To enable autonomous detection, the team equipped the device with several sensors that continuously monitor the user’s respiratory rate, heart rate, body temperature, and blood oxygen saturation. These sensors are connected to an algorithm trained to detect the signs of an overdose by integrating the various cardiorespiratory signals.
When the device detects a suspected opioid overdose, it begins to buzz to alert the user and sends an alert to their phone, allowing the user to cancel naloxone administration if an overdose is not occurring. If that does not happen, the device administers a naloxone shot directly into the user’s tissue.
“Beyond the closed circuit, the device can also serve as an early detection or warning system and help bring others – be it family members, medical personnel or emergency services – to the person’s side so they too can intervene,” said Traverso.
“To combat the high mortality rate associated with opioid overdoses, our fully implantable iSOS – with its continuous monitoring and ability to deliver rapid drug infusion – could serve as a critical next-generation antidote platform,” said co-first author Seungho Lee, PhD, a scientist at MIT and in the Department of Medicine at Brigham and Women’s Hospital.
The prototype measures 8mm x 12mm x 78mm (larger than a contraceptive implant but smaller than a subcutaneous defibrillator). It has a wirelessly rechargeable battery that lasts up to 14 days, a refillable medication reservoir, and can be implanted subcutaneously in a minimally invasive procedure under local anesthesia. The team tested the device’s safety and efficacy in a large animal model and found that the device was effective in detecting and reversing opioid overdoses in 24 of 25 pigs.
The researchers note that the device could be particularly useful for people who have already overdosed, as these people are at greater risk of overdosing again. They also say that an implantable device may be more effective than a wearable device.
“The problem with wearables is that you have to wear them, and that alone presents a potential challenge from an adherence perspective,” says Traverso. “If the patient really wants to protect themselves from an overdose, an implantable or ingestible device could help provide that kind of general vision support.”
The researchers are currently working on further optimizing and miniaturizing the device and intend to conduct further preclinical studies before starting human testing. They also plan to collect data on end-user preferences to guide their development work.
“Understanding the preferences of this patient population will be a critical part of our ongoing work to develop and advance this technology,” Traverso said. “This is only the first prototype created in the lab, but even at this stage we see that this device has a lot of potential to protect high-risk groups from an overdose that could otherwise be fatal.”
Authorship: In addition to Traverso Chai and Lee, BWH authors include co-first author Hen-Wei Huang, Tom Kerssemakers, Ali Imani, Jack Chen, Marco Heim, Jessica Y. Bo, Adam Wentworth, Fokion T. Sanoudos-Dramaliotis, Ian Ballinger, Alexander Alexiev, Jason Li, and Siheng Sean You. Other authors include Saurav Maji, Matt Murphy, Gloria H Kang, Niora Fabian, Josh Jenkins, Andrew Pettinari, Keiko Ishida, Alison M. Hayward, and Anantha Chandrakasan.
Disclosures: The authors declare the filing of a provisional patent application (PCT/US2022/080385) describing the materials and applications of the systems described here. Complete details of all of Traverso’s commercial and non-commercial relationships can be found at the link below. All other authors declare that they have no competing interests. The work described in this manuscript was funded by Novo Nordisk, McGraw Family Funding, the MIT Department of Mechanical Engineering, and the MIT Karl Van Tassel (1925) Career Development Professorship Chair. Chai was funded by NIH DP2DA056107.
Funding: Novo Nordisk, The McGraw Family Foundation, MIT Department of Mechanical Engineering, MIT Karl Van Tassel (1925) Chair in Career Development.
Paper cited: Huang, H et al. “An implantable system for opioid safety (iSOS)” Device DOI: 10.1016/j.device.2024.100517
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