Development of an implantable closed-loop system for delivery of naloxone for the prevention of opioid-related overdose deaths

摘要 目前肆虐全国的阿片类药物相关死亡的流行需要创新的治疗方法 阿片类药物使用障碍和防止意外过量造成的死亡。有阿片类药物史的患者 在戒酒一段时间后使用，服药过量的风险特别高。这种增加的风险源于 在长时间的使用中形成耐受性。在一段时间内，耐受性可能会很快消失 禁欲，因此，如果患者复发并服用与禁欲前相同的剂量，剂量 将高到足以引发急性呼吸危机，导致受伤或死亡。目前的治疗需要 急救人员对纳洛酮的管理。这种治疗需要及时识别过量用药和 需要进行救援注射，以及立即可以获得药物。一个失败的发展-- 无需他人干预即可提供挽救生命剂量的纳洛酮的安全治疗 可显著降低死亡率。在目前的应用中，我们建议开发一种新的 包括可植入的闭环系统的医疗装置，该系统感知阿片类药物过量的存在， 并自动注射纳洛酮救命团注，同时首先发出警报 响应者。这项建议建立在调查小组在过去几年中开发的技术基础上 好几年了。

Abstract The current epidemic of opioid-related deaths ravaging the nation demands innovative new approaches to treat opioid use disorders and prevent deaths resulting from accidental overdose. Patients with a history of opioid use followed by a period of sobriety are at particularly high risk for overdose. This increased risk stems from the development of tolerance during prolonged periods of use. Tolerance can quickly fade during a period of abstinence, so if a patient relapses and takes the same dose used prior to the period of abstinence, the dose will be high enough to precipitate an acute respiratory crisis, leading to injury or death. Current treatment requires administration of naloxone by first responders. This treatment requires timely identification of the overdose and need for a rescue injection, as well as the immediate availability of the medication. The development of a fail- safe treatment that would provide a life-saving dose of naloxone without the need for intervention by another party could significantly reduce mortality. In the present application, we propose the development of a new medical device comprising an implantable, closed-loop system that senses the presence of an opioid overdose, and automatically administers a life-saving bolus injection of naloxone, and simultaneously alerts first responders. This proposal builds on technologies that the investigative team has developed over the past several years.