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

项目摘要/摘要 杰森·罗斯博士提交了关于特殊利益通知的行政补充材料： 根据PA-18-591提供针对2019年冠状病毒病(新冠肺炎)的行政补充 机会。家长奖助金是Rose博士的K08 HL136857导师研究职业发展奖。Dr。 罗斯是匹兹堡大学医学和生物工程学助理教授。他的父母给了他 重点介绍一氧化碳(CO)中毒对心血管和线粒体的影响以及临床前 一氧化碳中毒解毒剂的研制。作为一名肺部和重症监护医生，罗斯医生一直 护理ICU中的新冠肺炎患者。他帮助领导了匹兹堡大学医学院的准备工作 中心系统，以确保健康的个人防护设备和生物电子(如呼吸机)供应链。 新冠肺炎大流行已在全球蔓延，截至2019年，美国已有100多万病例 2020年5月。高达11.5%的美国病例需要入住重症监护病房(ICU)。在一种情况下 部分人群(5%)在短时间内--通过“第二波”感染--发展成新冠肺炎 或病毒突变增加严重性或传染性--高达1,000,000人可能需要一些机械通风 模特们。在新冠肺炎出现之前，美国医院只拥有6.2万台全功能呼吸机。美国联邦政府的倡议 政府将援引国防生产法案(DPA)生产13万台新通风机，成本超过2.5美元 十亿美元。此外，虽然DPA已经启动了呼吸机的最终组装，但很可能会有一个 关键部件(如先进半导体)短缺。相反，可用的低成本和易于- 自制急救呼吸机功能有限，不能可靠地支持新冠肺炎急性加重期患者的呼吸机 呼吸窘迫综合征。这些简单的设备让有限的重症监护工作人员负担更多 病人监测和额外培训。限制与患者不必要的接触将保护工人。 这项提议的中心目标是开发一种快速制造的全功能成人ICU呼吸机 (“机器人呼吸机”-RoboVent)，可远程控制，以满足最坏情况下的全球呼吸机需求 价格合理(每台800英镑)。目标1：该设备的原型将使用机器人原理，使用易于操作的 制造组件。RoboVent将提供闭环压力辅助控制(AC)、音量AC和 压力支撑式通风方式。采用由我们开发的新型传感、控制和驱动技术 该呼吸机将完全控制驾驶压力(或潮气量)、呼气末正压、 呼吸频率和吸气呼气比。目标2：将验证该设备的内部一致性 并使用测试肺模拟器针对商业上可获得的成人ICU呼吸机单元进行测试。飞行员 生产批次将以类似方式进行验证。这些数据将提交FDA紧急使用授权。 在这项工作之后，这项技术将被授权给一个新的启动实体和多达10,000个FDA批准的远程 每周一次的呼吸机可以与制造合作伙伴富士康科技集团一起部署。

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.