Pandemic or Mass Casualty Aseptic Shared Ventilation

描述(申请人提供)：美国疾病控制与预防中心的FluSurge模拟显示，当H5N1流感病毒变异为通过空气传播的人与人之间的传播以及大流行到来时，美国国内将出现呼吸机短缺。在美国，据估计，10.5万台呼吸机中近85%的设备在任何时候都在使用，剩下的1.6万台可用于应对流感袭击。然而，对于疑似中度至重度H5N1禽流感的情况，有必要 将用于超过65,000-742,500台呼吸机，保守地花费5亿至62亿美元购买。 共享呼吸机是一种从根本上独特的方法，它打破了目前一台呼吸机对一名患者心态的界限。拟议的项目是展示和商业化下一代、基本上是一次性的呼吸机系统，在最初的形式中，它可以使用几乎任何可用的呼吸机，并可以为多达6-8名患者提供通风，而无需担心交叉污染。此外，还为每个患者提供个性化的呼吸设置，包括：氧气浓度(Fi02)、潮气量和分钟通气量以及呼气末正压(PEEP)。此外，该系统将显著节约氧气，而氧气在大流行期间是一种同样稀缺的资源，其成本约为任何可用替代能源的1/3。向食品和药物管理局提交510K文件是这一阶段I/II提案的最终交付成果。公共卫生相关性：疾病控制中心(CDC)对可能的大流行情景进行的FluSurge模拟强调了全国范围内超过725,000台呼吸机的短缺。仅在纽约州，预计就有超过10万人的死亡是由缺乏呼吸机直接和间接造成的，这导致纽约州卫生部研究将呼吸机配给作为唯一解决方案的医疗和伦理问题。医疗保护设备(MCD)提供了一种创新的方法来解决大流行情景中预期的两大短缺(呼吸机可用性和氧气供应)，使一台呼吸机能够支持多个患者进行个性化的呼吸控制，而不会交叉污染。

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.