SBIR Phase I: A Novel Respiratory Ventilator for Clinical Care (COVID-19)

这个小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力是开发一种变革性呼吸机设计，旨在满足临床对支持先进通风模式的低成本(3000美元)、高功能、坚固耐用、模块化和低维护的呼吸机的需求。目前中档通风器的价格在8000至2万美元之间，高端通风器的价格高达5万美元。拟议的设计采用了高效率和低成本的现代技术，活动的功能元件很少。只使用了四个模块，旨在以快速释放、无需工具的方式连接在一起，不需要维修技术人员进行维护。该设计通过(A)支持移动设备的联网以进行远程监测，(B)与医院信息系统联网以集成患者记录和分析系统，(C)支持标准的呼吸患者回路管道和插管，(D)包括监测设置和警报，(E)支持医院氧气、钢瓶氧气、医疗空气和大气空气的使用，从而确保新的呼吸机将在现有的医院和急诊护理环境中工作。2019年全球机械呼吸机市场价值29.4亿美元，预计到2027年将达到125.4亿美元，原因是包括慢性阻塞性肺疾病和哮喘在内的呼吸系统疾病在全球范围内的患病率不断上升，以及新冠肺炎大流行。这一新设计将有利地影响临床环境，包括急性护理设施、转运系统、家庭保健和发展中国家。它是激增和规模要求的理想选择，例如医院储备、国家战略储备、大规模伤亡响应和人道主义任务。这个SBIR第一阶段项目利用应用的工程原理和对可压缩流体力学的了解。它充分利用了计算机辅助设计和工程、3D打印、网络和低成本组件的使用，并考虑到了医院协议。新颖的创新包括：(A)用于空气/氧气输送的正排量、容积式空气动力系统，以及(B)用于空气动力系统流量控制的多位置单元件旋转选择阀。该奖项体现了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，认为值得支持该奖项。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a transformational ventilator design targeted at the unmet clinical need for low-cost ($3000), highly functional, rugged, modular and low maintenance ventilators supporting advanced ventilation modes. Current midrange ventilators cost between $8,000-20,000 with high-end ventilation units costing up to $50,000. The proposed design uses highly efficient and low-cost modern technologies with few moving functional elements. Only four modules are employed, designed to connect together in a quick-release, tool-less fashion requiring no service technicians to maintain. The design ensures that the new ventilator will work in existing hospital and acute care settings by (a) supporting networking of mobile devices for remote monitoring, (b) networking to hospital information systems to integrate with patient records and analytic systems, (c) supporting standard breathing patient circuit tubing and intubation tubes, (d) inclusion of monitoring settings and alarms, (e) supporting the use of hospital oxygen, oxygen in cylinders, medical air and atmospheric air. The global mechanical ventilator market was valued at $2.94 billion in 2019 and is estimated to reach $12.54 billion by 2027, driven by the rising worldwide prevalence of respiratory diseases including Chronic Obstructive Pulmonary Disease (COPD) and asthma, as well as the COVID-19 pandemic. This new design will favorably impact clinical settings including acute care facilities, in-transit systems, home health care and developing countries. It is ideal for surge and scale requirements, such as stockpiling by hospitals, strategic national stockpiles, mass casualty response and humanitarian missions.This SBIR Phase I project leverages applied engineering principles and understanding the mechanics of compressible fluids. It leverages the use of computer-aided design and engineering, 3D printing, networking and low-cost components in consideration of hospital protocols. Novel innovations include: (a) positive displacement, volumetric air motive system for air/O2 delivery, and (b) a multi-position single element rotary selector valve for flow control of the air motive system. An inexpensive bill of materials is achieved with minimal components for low weight (4 pounds not including battery backup), small logistics footprint, minimal component failure points, ease of maintenance and rapid scale of manufacture.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.