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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是开发一种变革性的呼吸机设计，以满足临床对低成本（3000美元）、高功能、坚固耐用、模块化和低维护的呼吸机的需求，支持先进的通风模式。目前，中档通风设备的价格在8,000-20,000美元之间，高端通风设备的价格高达50,000美元。建议的设计采用了高效、低成本的现代技术，几乎没有移动的功能元素。仅采用了四个模块，旨在以快速释放，无需工具的方式连接在一起，无需维修技术人员维护。通过(a)支持远程监测移动设备联网，(b)与医院信息系统联网，与病人记录和分析系统集成，(c)支持标准呼吸病人回路管和插管，(d)包括监测设置和警报，(e)支持使用医院氧气、钢瓶氧气、医用空气和大气空气，确保新的呼吸机能够在现有的医院和急性护理环境中工作。2019年，全球机械呼吸机市场的价值为29.4亿美元，预计到2027年将达到125.4亿美元，这是由于慢性阻塞性肺疾病（COPD）和哮喘等呼吸系统疾病的全球患病率上升，以及COVID-19大流行的推动。这种新设计将对临床环境产生积极影响，包括急症护理设施、中转系统、家庭卫生保健和发展中国家。它是满足激增和规模需求的理想选择，例如医院储备、国家战略储备、大规模伤亡应对和人道主义特派团。SBIR一期项目利用了应用工程原理和对可压缩流体力学的理解。它利用计算机辅助设计和工程、3D打印、网络和低成本组件，同时考虑到医院协议。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。低成本的材料清单是用最小的组件实现的，重量轻（4磅，不包括备用电池），物流足迹小，组件故障点最小，易于维护和快速制造规模。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.