Developing a Low-Cost Intelligent Ventilator with Remote Control for Rapid, Global Deployment and Minimal Healthcare Provider Exposure

开发具有远程控制功能的低成本智能呼吸机，以实现快速全球部署并最大限度地减少医疗保健提供者的暴露

• 批准号: 10166226
• 负责人: Jason J Rose
• 金额: $ 16.07万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10166226
• 关键词: 2019-nCoV; Address; Administrative Supplement; Admission activity; Adult; Adult Respiratory Distress Syndrome; Affect; Antidotes; Authorization documentation; Automobile Driving; Biomedical Engineering; Breathing; COVID-19; COVID-19 pandemic; Carbon Monoxide Poisoning; Cardiovascular system; Case Fatality Rates; Collaborations; Critical Care; Data; Development; Devices; Disease; Electronics; Emergency Situation; Engineering; Equipment; Event; Exposure to; Federal Government; Funding; Government; Health Personnel; Health system; Healthcare; Healthcare Systems; Hospitals; Hypersensitivity; Infection; Institutes; Intelligence; Intensive Care Units; Intervention; K-Series Research Career Programs; Lead; Licensing; Lung; Masks; Measures; Mechanical ventilation; Mechanics; Medical center; Medicine; Mentors; Michigan; Mitochondria; Modeling; Modernization; Monitor; Mutation; Parents; Patient Care; Patient Monitoring; Patients; Performance; Persons; Physicians; Population; Positive-Pressure Respiration; Preparation; Production; Provider; Research; Resistance; Resources; Resuscitation; Risk; Robotics; Running; Seasons; Secure; Semiconductors; Severities; Social Distance; System; Taxes; Technology; Testing; Tidal Volume; Time; Training; United States; Universities; Validation; Ventilator; Viral; Virus; Wireless Technology; Work; base; burden of illness; coronavirus disease; cost; design; experience; falls; graphical user interface; interest; low income country; manufacturing process; novel; pandemic disease; parent grant; preclinical development; pressure; printed circuit board; professor; prototype; remote control; respiratory; sensor; simulation; smartphone Application; success; telehealth; ventilation

PROJECT SUMMARY/ABSTRACT Dr. Jason Rose is submitting this administrative supplement in regards to the Notice of Special Interest: Availability of Administrative Supplements on Coronavirus Disease 2019 (COVID-19) under the PA-18-591 opportunity. The parent grant is Dr Rose’s K08 HL136857 Mentored Research Career Development Award. Dr. Rose is an Assistant Professor of Medicine and Bioengineering at the University of Pittsburgh. His parent grant focuses on the cardiovascular and mitochondrial effects of carbon monoxide (CO) poisoning and preclinical development of an antidote for CO poisoning. As a pulmonary and critical care physician, Dr Rose has been caring for patients with COVID-19 in the ICU. He helped lead preparations at the University of Pittsburgh Medical Center system to secure a healthy personal protective equipment and biotronic (e.g. ventilators) supply chain. The COVID-19 pandemic has progressed around the globe with over one million cases in the United States by May 2020. Up to 11.5% of US cases require intensive care unit (ICU) admission. In a scenario where a significant portion of the population (5%) develops COVID-19 in a short time period - through a “second-wave” of infection or viral mutation increasing severity or infectivity - up to 1,000,000 could require mechanical ventilation in some models. US hospitals only owned 62,000 full-featured ventilators before COVID-19. Initiatives by the US federal government to invoke the Defense Production Act (DPA) will produce 130,000 new ventilators costing over $2.5 billion dollars. Further, while the DPA has activated the final assembly of ventilators, there is likely to be a shortage of key components (e.g. advanced semiconductors). Conversely, available low-cost and easy-to- fabricate emergency ventilators have limited function and cannot reliably ventilate COVID-19 patients with acute respiratory distress syndrome. These simple devices tax the limited critical care workforce with more bedside patient monitoring and additional training. Limiting unnecessary exposures to patients will protect workers. The central objective of this proposal is to develop a rapidly manufactured, full-capability adult ICU ventilator (“Robotic Ventilator” – RoboVent) that can be controlled remotely to meet worst-case global ventilator demand at reasonable cost (<$800/unit). Aim 1: The device will be prototyped, using robotic principals, using easy-to- fabricate components. The RoboVent will provide closed-loop pressure assist-control (AC), volume AC and pressure-support modes of ventilation. Using novel sensing, control and actuation technology, developed by our group, the ventilator will offer full control over driving pressure (or tidal volume), positive end-expiratory pressure, respiratory rate, and inspiratory to expiratory ratio. Aim 2: The device will be validated for internal consistency and tested against commercially available adult ICU ventilator units using a test lung simulators. A pilot production batch will be validated similarly. These data will be submitted for FDA emergency use authorization. Following this work, the technology will be licensed to a new startup entity and up to 10,000 FDA-cleared remote ventilators per week can be deployed in conjunction with manufacturing partner Foxconn Technology Group.

项目摘要/摘要 杰森·罗斯（Jason Rose）博士正在就特殊关注通知提交此行政补充： PA-18-591下的冠状病毒疾病的行政补品的可用性 机会。父母赠款是Rose博士的K08 HL136857指导研究职业发展奖。博士 罗斯是匹兹堡大学医学和生物工程助理教授。他的父母赠款 专注于一氧化碳（CO）中毒和临床前的心血管和线粒体作用 开发用于中毒的解毒剂。作为肺和重症医师，罗斯博士一直是 照顾ICU中Covid-19患者。他帮助匹兹堡大学医学大学领导准备工作 中心系统，以确保健康的个人保护设备和生物特征（例如呼吸机）供应链。 199年，美国的大流行在全球范围内，美国超过一百万个案件。 2020年5月。多达11.5％的美国案件需要重症监护室（ICU）入学。在一个重要的情况下 人口的一部分（5％）在短时间内开发了COVID-19 - 通过感染的“第二波” 或病毒突变增加严重程度或感染 - 多达1,000,000可能需要机械通气 型号。美国医院在Covid-19之前只拥有62,000个全功能的呼吸机。美国联邦的倡议 政府援引《国防生产法》（DPA）将生产130,000个新呼吸机，价格超过2.5美元 十亿美元。此外，虽然DPA激活了呼吸机的最终组装，但可能会有一个 关键组件短缺（例如高级半导体）。相反，可用的低成本且易于 - 制造紧急呼吸机的功能有限，无法可靠地通风急性19例患者 呼吸窘迫综合征。这些简单的设备对有限的重症监护劳动力征税 患者监测和其他培训。限制对患者的不必要暴露将保护工人。 该提案的核心目的是开发快速制造的全能力成人ICU呼吸机 （“机器人呼吸机” - robovent）可以远程控制以满足最坏的全球呼吸机需求 以合理的成本（<$ 800/单位）。 AIM 1：使用易于使用的机器人主体将原型进行原型 制造组件。机器人将提供闭环压力辅助控制（AC），体积AC和 压力支持通风模式。使用我们的新型感测，控制和驱动技术，由我们开发 组，呼吸机将对驾驶压力（或潮汐体积），正呼气压力提供完全控制， 呼吸速度和到期率的灵感。 AIM 2：将验证该设备的内部一致性 并使用测试肺模拟器对市售成人ICU通风单元进行了测试。飞行员 生产批次将被类似验证。这些数据将提交FDA紧急使用授权。 在这项工作之后，该技术将获得新的创业实体的许可，并最多10,000 fda被清除的遥控器 每周可以与制造合作伙伴Foxconn Technology Group一起部署呼吸机。