An implantable system for opioid safety

The bigger pictureThe opioid epidemic continues to cause significant morbidity and mortality across the US. The implantable system for opioid safety (iSOS) is an implantable, autonomous device that measures vital signs and detects opioid overdose events. The system is implanted under the subcutaneous tissue, has a rechargeable battery that can last up to 14 days, and contains an integrated, refillable drug reservoir that holds a 10-mg naloxone payload. Detection of opioid overdose is facilitated by a unique sensor-fusion algorithm that confirms a likely opioid overdose. A pumping mechanism then rapidly infuses naloxone to reverse the overdose. Testing of the components of the iSOS in a swine model demonstrates the ability of the iSOS to detect both rapid opioid overdose with apnea and gradual opioid poisoning with hypopnea, for both of which naloxone is indicated. The iSOS is a system that may ultimately benefit patients and clinical providers by providing individuals with opioid use disorder with an extra layer of protection to prevent a fatal overdose.Highlights•An implantable system that detects opioid overdose and automatically delivers naloxone•A sensor fusion algorithm accurately detects opioid overdose•iSOS could help protect patients from fatal opioid overdose•iSOS evaluation in a swine opiate overdose modelSummaryNaloxone can effectively rescue victims from opioid overdose, but less than 5% survive due to delayed or absent first responder intervention. Current overdose reversal systems face key limitations, including low user adherence, false positive detection, and slow antidote delivery. Here, we describe a subcutaneously implanted robotic first responder to overcome these challenges. This implantable system for opioid safety continuously monitors vital signs, detecting opioid overdose through an algorithm analyzing the interplay of cardiorespiratory responses. To address battery concerns with continuous monitoring and multi-sensing modality, an adaptive algorithm dynamically adjusts sensor resolution, reducing the need for frequent charging. Furthermore, the implant includes an ultra-rapid naloxone delivery pump, delivering the 10-mg antidote within 10 s. In animal trials, the robotic first responder successfully revived 96% of overdosed pigs (n = 25) within 3.2 min, showcasing its potential to dramatically improve survival rates and combat the opioid epidemic.