A low-cost, highly functional, emergency use ventilator for the COVID-19 crisis

Abstract

Respiratory failure complicates most critically ill patients with COVID-19 and is characterized by heterogeneous pulmonary parenchymal involvement, profound hypoxemia and pulmonary vascular injury. The high incidence of COVID-19 related respiratory failure has exposed critical shortages in the supply of mechanical ventilators, and providers with the necessary skills to treat. Traditional mass-produced ventilators rely on an internal compressor and mixer to moderate and control the gas mixture delivered to a patient. However, the current emergency has energized the pursuit of alternative designs, enabling greater flexibility in supply chain, manufacturing, storage, and maintenance considerations. To achieve this, we hypothesized that using the medical gasses and flow interruption strategy would allow for a high performance, low cost, functional ventilator. A low-cost ventilator designed and built-in accordance with the Emergency Use guidance from the US Food and Drug Administration (FDA) is presented wherein pressurized medical grade gases enter the ventilator and time limited flow interruption determines the ventilator rate and tidal volume. This simple strategy obviates the need for many components needed in traditional ventilators, thereby dramatically shortening the time from storage to clinical deployment, increasing reliability, while still providing life-saving ventilatory support. The overall design philosophy and its applicability in this new crisis is described, followed by both bench top and animal testing results used to confirm the precision, safety and reliability of this low cost and novel approach to mechanical ventilation. The ventilator meets and exceeds the critical requirements included in the FDA emergency use guidelines. The ventilator has received emergency use authorization from the FDA.

Validation of a specialized evaluation system for COVID-19 in Japan: A retrospective, multicenter cohort study

“…During the COVID-19 pandemic, their efficient use is a critical issue to improve the quality of treatment due to a huge demand of MV with inequity problem of its distribution [ 33 ]. Moreover, various diseases discussed a new type of MV with both a lower cost of introduction and user friendliness [ [34] , [35] , [36] , [37] , [38] ]. Therefore, we believe that the prevention of the aggravation is required to solve this issue because the prevention can decrease unexpected use of MV and ICU.…”

Development and performance evaluation of a solenoid valve assisted low-cost ventilator on gas exchange and respiratory mechanics in a porcine model

“…As the pandemic progressed, the proportion on COVID-19 patients requiring hospitalization, intensive care, and mechanical ventilation in the ICU has stabilized throughout the surges [ 15 , 16 ]. As a result, the initial concern of ventilator shortage has decreased; however, with recent occurrences of other natural disasters, threat of terrorism, and possible future pandemics, there continues to be a need for mass-casualty mechanical ventilation beyond the national stockpile program [ 16 ].…”

High potential of technology to face new respiratory viruses: mechanical ventilation devices for effective healthcare to next pandemic emergencies

“…Manifold factors affect the negative impact of COVID-19 pandemic in society, such as high air pollution and density of people in cities [ 9 ], intensive commercial trade between countries [ 10 , 11 ], low investments in healthcare sector, etc. [ 12 , 13 ], etc.. COVID-19 with initial variants Alfa and Delta generated critically respiratory failure in ill patients, heterogeneous pulmonary parenchymal involvement, profound hypoxemia, pulmonary vascular injury and other negative health effects [ 14 ]. One of the treatments in the initial stage of the COVID-19 pandemic is the application, to patients with respiratory disorders, of mechanical ventilator that is based on an internal compressor and mixer to moderate and control the gas mixture delivered to ill patients.…”

“…Jones [ 18 ] argues that in India only 50% of intensive care units has a mechanical ventilator. Innovative projects were launched, during the initial phase of COVID-19 pandemic crisis in 2020, to solve this problem of the shortage of ventilators in order to improve manufacturing and flexibility in supply chain, also with strategic partnership and collaborative networks in this industry to boost R&D performance, production, storage and maintenance of ventilators [ 14 , [19] , [20] , [21] , [22] , [23] , [24] , [25] ]. A main example is product development of the PocketVent ventilator in less than six months with efficient technical characteristics of pressure and volume controlled to help in breathing [ 17 ].…”

“…A main example is product development of the PocketVent ventilator in less than six months with efficient technical characteristics of pressure and volume controlled to help in breathing [ 17 ]. Other scholars suggested that the use of medical gasses and flow interruption strategy can support high performance and low cost in ventilator technology [ 14 ]. This technological approach reduces many physical components present in traditional ventilators, shortens the time from storage to clinical deployment, improves reliability in terms of life-saving ventilatory support, satisfying emergency guidelines of the U.S. FDA.…”