Opioid related deaths in the US are increasing at a staggering rate. The CDC estimates that the number of deaths related to opioid overdose has tripled over the last 15 years. In 2014 there were 28,647 opioid overdose deaths – more than any other year on record. This number is even more devastating given the propensity of opioid overdose to strike at such a young age. This is quite a contrast from other substances such as alcohol and tobacco where users often fail to achieve sobriety early in life, but may live long enough to do so in later decades. Thus, an aggressive approach to prevent overdose is critical in order to give opioid users the best chance of achieving recovery and chance at a fulfilling life.
The overdose reversal drug naloxone has achieved dramatic results in combatting the opioid epidemic, yet given the record numbers, additional approaches must be considered. The efficacy of this medication is limited by having the medication on site as well as the presence of a caring bystander. The importance of this limitation cannot be understated, because overdoses are unpredictable and opioid users are not always nearby other capable individuals.
Given that so many people use opioids alone, and naloxone is incredibly effective when administered early on during the course of overdose, it would follow that a device capable of delivering naloxone automatically could have a dramatic impact. It can take over 10 minutes for EMT personnel to arrive once alerted to an overdose, and often there is a delay in calling them, both of which can dramatically raise the risk of death following accidental overdose. By addressing these issues and improving the way in which naloxone is administered, thousands of lives could be saved every year.
The Opioid Recovery Bracelet (ORB) is a novel design that can detect signs of overdose and automatically administer life-saving naloxone without the participation of bystanders or first responders. The ORB combines wearable technology that can detect physiological changes of overdose, and activate the device to inject naloxone into the patient’s tissues. This device obviates the need for bystander administration, which is a major disadvantage of existing solutions. Physiologic parameters including pulse oximetry and heart rate could serve as inputs into an algorithm that determines necessity for medication administration. A pressurized injector, electrically activated, will eject a needle through which a dose of naloxone will be infused.
The ORB is a bracelet worn on the wrist. It is discrete, light in weight, and appears similar in design to other watches or fit-bits to reduce the chance that it could be used to easily identify opioid users. It would measure physiological data in real-time and trigger a response once an algorithm detected an overdose had occurred. Early research supports the use of pulse oximetry as the best tool for determining overdose given the ease of recording this data with established technology, and its utility at recognizing overdose. Still, other data such as respiratory rate using photoplethysmography could be used to increase the accuracy and efficacy of the device, though this will have to be evaluated further.
The device will recognize changes in pulse oximetry that occur during overdose, yet not react to changes that occur simply during typical opioid use. To alleviate concerns that patients may have about inadvertent naloxone injections, there will be an abort or “snooze” button that may be pressed in the unlikely event of a false positive.
Each ORB will contain 2 vials of naloxone 1.2 mg. This dose permits the reversal of overdose even due to large doses of synthetic opioids like fentanyl and carfentanil. Having 2 vials will permit a second dose to be administered should the first not be sufficient, but also to provide a safety net until the device can be serviced after an overdose reversal.
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