When someone overdoses on opioids, it’s critical that they get a dose of the opioid-reversing drug naloxone as soon as possible—otherwise, death is a certainty. That’s where a new implant comes in, because it automatically distributes naloxone throughout the body.
The iSOS implant, whose name is an acronym for “Implantable System for Opioid Safety,” is being developed by a team of scientists from MIT and Harvard's Brigham and Women's Hospital.
The device is 78 mm long, 12 mm wide and 8 mm thick. It contains 10 milligrams of naloxone in an integrated chamber, as well as electronics such as a battery, vibrator and Bluetooth module, plus multiple ECG electrodes and a number of other sensors.
Ideally, it would be implanted just under the skin near the solar plexus. This procedure can be performed quickly in a clinic using local anesthesia.
Once in place, iSOS monitors a patient’s temperature, heart rate, respiratory rate, and blood oxygen saturation. If these parameters change in a way that indicates an opioid overdose is occurring, the device activates a vibration device to produce both a tactile and auditory alert.
It also sends an alert to an app on the patient’s smartphone. In the event of a false positive, the patient can use the app to “stop” the implant. But if they don’t do so immediately, iSOS will quickly start pumping a dose of naloxone into the bloodstream. The app will also send an alert to a pre-determined emergency contact.
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In laboratory tests, the device successfully revived 96% of fentanyl-overdosed pigs in an average of 3.2 minutes. Its battery is currently sufficient for 16 days of vital signs monitoring and can be wirelessly recharged when needed.
The naloxone reservoir can be filled with a hypodermic needle inserted through the skin into a port on the implant. Given that the drug persists at body temperature for at least 14 days, patients are expected to return to the clinic every two weeks for battery charging and refilling.
We saw that without implants The team behind iSOS, wearable devices designed for use by opioid addicts seeking relief from accidental overdoses, notes that these systems often don’t deliver enough naloxone quickly enough. And because these devices have to be manually inserted into the body every day, it’s likely that many people will stop using them over time.
“This could really address a significant unmet need in the substance abuse and opiate addiction population to help reduce overdoses, by initially focusing on high-risk populations,” says Associate Professor Giovanni Traverso of MIT, the study’s senior author.
It is hoped that human trials will begin in three to five years, at which time development of the naloxone-delivering implant under development at Northwestern University will progress further.
A paper on the MIT research was recently published in the journal Device.
Source: MIT