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

开发用于输送纳洛酮的植入式闭环系统，以预防阿片类药物相关的过量死亡

• 批准号: 10456452
• 负责人: Robert W Gereau
• 金额: $ 627.51万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2024-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10456452
• 关键词: Abstinence; Acute; Animals; Blood gas; Bluetooth; Bolus Infusion; Cells; Cellular Phone; Cessation of life; Clinical; Clinical Trials; Communication; Computer software; Dangerousness; Data; Detection; Development; Device or Instrument Development; Devices; Dose; Elements; Emergency Situation; Ensure; Event; Family; Family suidae; Fentanyl; Funding; Goals; Human; Injections; Injury; Intervention; Intranasal Administration; Intravenous; Leadership; Legal patent; Licensing; Life; Measurement; Measures; Medical Device; Microfluidics; Naloxone; Nature; Opioid; Overdose; Oxygen saturation measurement; Patient Care; Patients; Pharmaceutical Preparations; Phase; Pilot Projects; Plasma; Positioning Attribute; Prevention; Protocols documentation; Rattus; Recording of previous events; Risk; Savings; Science; Self Administration; Signal Transduction; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Subcutaneous Injections; System; Technology; Telephone; Testing; Time; Translations; Ventilatory Depression; Wireless Technology; appropriate dose; biomaterial compatibility; commercialization; design; first responder; high risk; implantable device; innovation; mortality; novel strategies; opioid epidemic; opioid mortality; opioid overdose; opioid use; opioid use disorder; overdose death; overdose risk; preclinical trial; prevent; relapse patients; respiratory; sobriety; stem; subcutaneous; success; tissue oxygenation

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.

抽象的 当前与阿片类药物相关死亡的流行病破坏了国家，需要创新的新方法来治疗 阿片类药物使用障碍并防止因意外过量导致死亡。有阿片类药物史的患者 使用后期清醒的使用尤其高于服用过量的风险。这种风险增加源于 长期使用期间的公差发展。公差会在一段时间内迅速消失 禁欲，因此，如果患者复发并服用相同的剂量，则剂量 将足够高，可以造成急性呼吸危机，导致受伤或死亡。当前的治疗需要 第一响应者对纳洛酮进行管理。这种治疗需要及时识别过量和 需要进行救援注射以及药物的立即供应。失败的发展 安全的治疗将提供挽救生命剂量的纳洛酮，而无需另一个人干预 政党可以大大降低死亡率。在本应用中，我们建议开发新的 包括植入式闭环系统的医疗设备，该系统感知到阿片类药物过量的存在， 并自动管理挽救生命的纳洛酮注射推注，并同时发出警报 响应者。该提案是基于调查团队在过去的几个技术发展的基础 年。