Pandemic or Mass Casualty Aseptic Shared Ventilation

描述（由申请人提供）：美国疾病控制与预防中心的FluSurge模拟显示，当H5N1流感病毒变异为空气传播的人际传播并大流行到来时，美国境内将出现呼吸机短缺。在美国，据估计，在105,000台呼吸机中，有近85%的呼吸机随时处于使用状态，剩下超过16,000台可用于应对流感发作。然而，对于疑似中度至重度H5N1禽流感的情况，需要

DESCRIPTION (provided by applicant): The CDC's FluSurge simulation shows that there will be a shortage of ventilators within the United States when the H5N1 flu virus mutates to airborne human-to-human transmission and the pandemic arrives. In the United States, it is estimated that nearly 85% of the 105,000 ventilators are in use at any time resulting, leaving in than 16,000 available to respond to a flu attack. However, for the suspected moderate to severe H5N1 Avian flu scenario, the need would be for over 65,000-742,500 ventilators conservatively costing $500 million to $6.2 billion to procure. Shared ventilation is a fundamentally unique approach which breaks the boundaries of current 1 ventilator to 1 patient mindset. The proposed project is to demonstrate and commercialize a next generation, largely disposable ventilator systems, which in its initial form, can use virtually any available ventilator and can provide ventilation for up to 6-8 patients without worries about cross contamination. In addition, each patient is provided individualized respiratory settings, including: oxygen concentration (Fi02), tidal volume and minute ventilation, and positive end expiratory pressure (PEEP). Furthermore, the system would significantly conserves oxygen, an equally scarce resource during pandemics, and cost ~1/3rd of any available alternative. Filing a 510k submission to the Food & Drug Administration is the final deliverable of this Phase I/II proposal. PUBLIC HEALTH RELEVANCE: The Centers for Disease Control's (CDC) FluSurge simulation of likely pandemic scenarios highlights a nationwide shortage of more than 725,000 ventilators. In New York State alone, over 100,000 deaths are forecasted to be directly and indirectly caused by this lack of ventilators leading The New York State Department of Health to study the medical and ethical issues of ventilator rationing as the only solution. Medical Conservation Devices (MCD) provides an innovative approach to resolve two major shortages (ventilator availability and oxygen supply) anticipated during a pandemic scenario by making it possible for one ventilator to support multiple patients with individualized respiratory control without cross contamination.