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

基本信息

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
项目类别：
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

项目摘要

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.

抽象的当前阿片类药物相关死亡在全国肆虐，需要创新的新方法来治疗阿片类药物使用障碍并预防因意外过量服用而导致的死亡。有阿片类药物使用史的患者使用后保持一段时间的清醒，过量的风险特别高。这种增加的风险源于长期使用时会产生耐受性。耐受性会在一段时间内迅速消失戒断，因此如果患者复发并服用与戒断前相同的剂量，则该剂量会高到足以引发急性呼吸道危机，导致受伤或死亡。目前的治疗需要急救人员给予纳洛酮。这种治疗需要及时识别过量并需要进行救援注射，以及立即获得药物。失败的发展安全的治疗，可提供挽救生命的纳洛酮剂量，无需其他人的干预方可显着降低死亡率。在本申请中，我们建议开发一种新的医疗设备，包括可植入的闭环系统，可感应阿片类药物过量的存在，并自动进行纳洛酮的救生推注，同时首先发出警报响应者。该提案建立在调查团队过去几年开发的技术基础上年。