ICORPS: User-centric development of closed-loop therapy for opioid overdose

项目摘要/摘要 这项快速通道SBIR提案将有助于在将Rescue Biomedical商业化方面取得重大进展 LLC的自动解毒剂输送装置(A2D2)，以打击阿片类药物过量相关的死亡。尽管 随着人们对阿片类药物相关危险的认识不断提高，有70000多人死于阿片类药物 2020年阿片类药物过量。此外，非法合成阿片类药物的日益流行和社会孤立 正在进行的新冠肺炎大流行正在推动第三波与阿片类药物相关的死亡。因为这些非法药物是 比吗啡强几个数量级，几分钟内就能导致呼吸衰竭，几乎没有 用户需要时间来识别和应对过量服用纳洛酮等解毒剂的症状。建议数 A2D2是一种低成本、简单的皮下给药胶囊，可以自动检测阿片类药物- 诱导呼吸衰竭，并以闭环方式释放纳洛酮。它将延长 给病人用药过量，这样他们才能得到适当的医疗护理。 在这个快速通道SBIR提案中，Rescue Biomedical试图验证其假设，即存在显著的 对用于阿片类药物自动检测和治疗的可穿戴-植入型组合设备的需求 服药过量。在第一阶段，Rescue Biomedical将与印第安纳大学学院的合作者合作 医学，量化用户使用可穿戴和可植入设备的意愿。此外，临床医生和 将确定其他利益相关者(例如，有执照的化学品依赖顾问)，以了解他们的 愿意推荐先进的减害设备。最后，Rescue Biomedical将利用 协调这些利益相关者以验证整体系统设计，以确保高合规性和可用性。在……里面 第二阶段，工作重点将放在技术集成和进行关键的临床前试验，以 展示逆转阿片类药物过量影响的闭环能力。此外，救援 生物医学将专注于商业化努力，包括提交IND/IDE提交的监管文件 以及根据用户反馈进行设计验证和确认。

Project Summary/Abstract This Fast-Track SBIR proposal will help make significant inroads towards commercializing Rescue Biomedical LLC's automatic antidote delivery device (A2D2) in order to combat opioid overdose-related deaths. Despite increasing awareness of the dangers associated with opioids, there were more than 70,000 deaths due to opioid overdose in 2020. In addition, the rising popularity of illegal synthetic opioids and social isolation due to the ongoing COVID-19 pandemic is fueling a third wave of opioid-related deaths. Since these illegal drugs are orders of magnitude more potent than morphine and can cause respiratory failure in minutes, there is very little time for users to identify and respond to the symptoms of overdose with antidotes like naloxone. The proposed A2D2 is a low-cost and simple subcutaneous drug delivery capsule that can automatically detect opioid- induced respiratory failure and release naloxone in a closed-loop manner. It will extend the lifetime of overdosed patients so that they can receive proper medical care. In this Fast-Track SBIR proposal, Rescue Biomedical seeks to validate its hypothesis that there is a significant demand for a wearable-implantable combinational device for automatically detecting and treating opioid overdose. In Phase I, Rescue Biomedical will work with its collaborator at Indiana University School of Medicine to quantify users' willingness to use wearable and implantable devices. Furthermore, clinicians and other stakeholders (e.g., Licensed Chemical Dependency Counselor) will be identified to understand their willingness to recommend advanced harm reduction devices. Finally, Rescue Biomedical will leverage the cohort of these stakeholders to validate the overall system design to ensure high compliance and usability. In Phase II, efforts will be focused on technical integration and performing a pivotal pre-clinical experiment to demonstrate the closed-loop capabilities to reverse the effects of opioid overdose. Moreover, Rescue Biomedical will focus efforts for commercialization including regulatory submissions for IND/IDE submission and performing design verification and validation based on user feedback.