SBIR Phase I: A Novel Respiratory Bag-Valve-Mask Resuscitator

这一小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是开发一种新型复苏器，用于呼吸衰竭或心脏骤停患者的复苏。 在美国，每年有近30万例院外心脏骤停病例和约35万例住院病例，心脏骤停存活患者数量仅增加5%，就相当于挽救了33，000多人的生命。2017年，50岁以下患者因院外心脏骤停死亡的直接和间接总成本为4550亿美元，估计因心脏骤停死亡的总成本为1.8万亿美元。在此基础上，每增加1%的院外心脏骤停存活率，将为美国经济节省45亿美元的成本。拟议的项目解决了与新设备相关的技术挑战。这个小型企业创新研究（SBIR）第一阶段项目推进了袋阀面罩复苏器的翻译，该复苏器限制了体积，压力，和通气率到安全水平的任何病人，从婴儿到成人。该项目的目标是设计和测试一个功能齐全的原型，该原型包含一个易于使用的机制，用于快速同时调整最大输送空气量和最大压力，以及一个限制通风率的机制。该项目的目标是：（1）制作原型并测试用于同时控制容量和压力的新型拨盘操作机制;（2）测试用于限制通气率的基于流量的机制;（3）将原型性能与由一组受过训练的医务人员使用的标准袋阀面罩复苏器的性能进行比较。该项目的成功完成将产生一个功能齐全的原型，一组关于设备性能的有价值的数据，以及最终用户对设计、易用性和设备功能的重要反馈，以告知未来的修改。该奖项反映了NSF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 the development of a novel resuscitator to ventilate patients with respiratory failure or cardiac arrest. With almost 300,000 cases of out-of-hospital cardiac arrest and approximately 350,000 in-hospital cases each year in the United States, a modest increase of just 5% in the number of patients surviving cardiac arrest would correspond to more than 33,000 additional lives saved. In 2017, the combined direct and indirect costs of deaths from out-of-hospital cardiac arrest for patients under 50 years of age to be $455 billion, with an estimate of $1.8 trillion for all deaths from cardiac arrest. On this basis, every 1% increase in the out-of-hospital cardiac arrest survival rate would result in a $4.5 billion cost saving to the United States economy.The proposed project addresses the technical challenges associated with a novel device.This Small Business Innovation Research (SBIR) Phase I project advance translation of a bag-valve-mask resuscitator that restricts the volume, pressure, and rate of ventilation to safe levels for any patient, from infant to adult. The goal of the project is to design and test a fully functioning prototype that incorporates an easy-to-use mechanism for quickly and simultaneously adjusting both the maximum volume of air delivered and the maximum pressure, and a mechanism for restricting ventilation rate. The project objectives are: (1) prototype and test a novel dial-operated mechanism for simultaneous volume and pressure control; (2) test a flow-based mechanism for restricting the ventilation rate; (3) compare the prototype performance with that of a standard bag-valve-mask resuscitator used by a group of trained medical personnel. Successful completion of this project will result in a fully functional prototype, a valuable set of data on the device performance, and important feedback from end-users on design, ease of use, and device functionality to inform future modifications.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.