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

PROJECT SUMMARY/ABSTRACTDr. 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-18-591opportunity. 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 grantfocuses on the cardiovascular and mitochondrial effects of carbon monoxide (CO) poisoning and preclinicaldevelopment of an antidote for CO poisoning. As a pulmonary and critical care physician, Dr Rose has beencaring for patients with COVID-19 in the ICU. He helped lead preparations at the University of Pittsburgh MedicalCenter 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 byMay 2020. Up to 11.5% of US cases require intensive care unit (ICU) admission. In a scenario where a significantportion of the population (5%) develops COVID-19 in a short time period - through a "second-wave" of infectionor viral mutation increasing severity or infectivity - up to 1,000,000 could require mechanical ventilation in somemodels. US hospitals only owned 62,000 full-featured ventilators before COVID-19. Initiatives by the US federalgovernment to invoke the Defense Production Act (DPA) will produce 130,000 new ventilators costing over $2.5billion dollars. Further, while the DPA has activated the final assembly of ventilators, there is likely to be ashortage 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 acuterespiratory distress syndrome. These simple devices tax the limited critical care workforce with more bedsidepatient 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 demandat 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 andpressure-support modes of ventilation. Using novel sensing, control and actuation technology, developed by ourgroup, 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 consistencyand tested against commercially available adult ICU ventilator units using a test lung simulators. A pilotproduction 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 remoteventilators per week can be deployed in conjunction with manufacturing partner Foxconn Technology Group.