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: 10022117
• 负责人: Robert W Gereau
• 金额: $ 209.91万
• 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 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10022117
• 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.

摘要