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流行病需要创新的新方法来治疗 阿片类药物使用障碍和预防意外过量导致的死亡。有阿片类药物史的患者 使用后经过一段时间的清醒是特别高的风险过量。这种增加的风险源于 在长期使用过程中产生耐受性。在一段时间内， 因此，如果患者复发并服用与禁欲期前相同的剂量， 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 第一反应者的纳洛酮给药。这种治疗需要及时识别过量， 需要急救注射，以及立即可用的药物。失败的发展- 安全的治疗，将提供一个挽救生命的剂量纳洛酮，而不需要干预的另一个 可以大大降低死亡率。在本申请中，我们提出了一种新的 一种医疗装置，其包括感测阿片类药物过量的存在的可植入闭环系统， 自动注射救命的纳洛酮，同时先发出警报， 响应者。这项建议是建立在调查小组在过去几年中开发的技术基础上的。 年

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.