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.

项目概要/摘要 Jason Rose 博士正在提交有关特别利益通知的行政补充： 根据 PA-18-591 提供有关 2019 年冠状病毒病 (COVID-19) 的行政补充 家长资助是 Rose 博士的 K08 HL136857 指导研究职业发展奖。 罗斯是匹兹堡大学医学和生物工程助理教授。 专注于一氧化碳 (CO) 中毒和临床前研究对心血管和线粒体的影响 作为一名肺部和重症监护医生，罗斯博士一直致力于开发一氧化碳中毒的解毒剂。 他帮助领导匹兹堡大学医学院的准备工作，在 ICU 照顾 COVID-19 患者。 确保健康的个人防护设备和生物电子（例如呼吸机）供应链的中心系统。 COVID-19 大流行已在全球范围内蔓延，美国的病例已超过 100 万例 2020 年 5 月。在这种情况下，高达 11.5% 的美国病例需要入住重症监护病房 (ICU)。 部分人口 (5%) 在短时间内感染了 COVID-19 - 通过“第二波”感染 或病毒突变增加严重性或传染性 - 某些地区可能需要机械通气多达 1,000,000 例 在美国联邦政府采取行动之前，美国医院仅拥有 62,000 台全功能呼吸机。 政府援引《国防生产法》(DPA) 将生产 130,000 台新呼吸机，成本超过 2.5 美元 此外，虽然 DPA 已经启动了呼吸机的最后组装工作，但可能还会有 关键部件（例如先进的半导体）短缺，成本低且易于制造。 制造的紧急呼吸机功能有限，无法可靠地为患有急性症状的 COVID-19 患者提供通气 这些简单的设备给有限的重症监护人员带来了更多的床边负担。 患者监测和额外培训将保护工作人员。 该提案的中心目标是开发一种快速制造、功能齐全的成人 ICU 呼吸机 （“机器人呼吸机”——RoboVent）可以远程控制，以满足最坏情况下的全球呼吸机需求 以合理的成本（< 800 美元/台） 目标 1：使用机器人原理，使用易于操作的方法对设备进行原型设计。 RoboVent 将提供闭环压力辅助控制 (AC)、体积 AC 和 采用我们开发的新型传感、控制和驱动技术。 组，呼吸机将提供对驱动压力（或潮气量）、呼气末正压、 目标 2：将验证设备的内部一致性。 并使用测试肺模拟器对商用成人 ICU 呼吸机进行了测试。 生产批次将进行类似的验证，这些数据将提交给 FDA 紧急使用授权。 这项工作完成后，该技术将被授权给一家新的初创实体和多达 10,000 个经 FDA 批准的远程 每周可与制造合作伙伴富士康科技集团合作部署呼吸机。