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

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是一种新型设备，它可以减少急救人员在使用袋式阀门面罩(BVM)手动复苏器时对患者的伤害。急救医务人员每天在院前和医院环境中使用BVMS，向危重患者输送空气。它们的基本设计已经存在了60多年，经常被误用，导致损坏、并发症，有时还会造成致命的肺损伤。该项目将完成一种新型BVM的开发，该BVM可以精确控制输送的体积和压力，并旨在重新定义停滞不前的BVM市场，预计到2025年，BVM市场的年收入将超过7.5亿美元。这个小型企业创新研究(SBIR)第二阶段项目开发了一种新型的、可调节的通用袋式阀门面罩复苏器，使急救提供者能够根据患者的身体大小提供定制的风量和压力。目前的设备经常被滥用，甚至被训练有素的医务人员使用，导致过度换气、气压创伤，偶尔还会死亡。该项目将完成剩余的设计和测试任务，并将进行人为因素概念验证研究，以证明用户能够在最少的指导下快速和正确地使用设备。第二个目标将在美国批准的标准内解决可制造性和测试要求。最后，第三个目标是建立组装过程和初始质量控制测试，以确保规模一致的制造，以成本效益和质量一致的方式。该奖项反映了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，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel device which reduces injury to patients by emergency personnel when using a bag-valve-mask (BVM) manual resuscitator. BVMs are used in pre-hospital and hospital settings by emergency medical personnel on a daily basis to deliver air to critically ill patients. Their basic design has been in place for over 60 years and are often misused resulting in damage, complications, or occasionally fatal lung injury. This project will complete development of a novel BVM that precisely controls the volumes and pressures delivered, and aims to redefine the stagnant BVM market which is projected to surpass $750M annually by 2025.This Small Business Innovation Research (SBIR) Phase II project develops a novel, adjustable, universal bag-valve-mask resuscitator enabling emergency providers to deliver air volumes and pressures customized to patient body size. Current devices are commonly misused, even by highly trained medical personnel, resulting in hyperventilation, barotrauma, and occasional death. The project will complete remaining design and testing tasks, and a human factors proof of concept study to demonstrate users are able to quickly and properly utilize the device with minimal instruction will be performed. The second objective will address manufacturability and testing requirements within standards for US approval. Finally, the third objective is to establish the assembly processes and initial quality control testing to ensure consistent manufacturing at scale and in a cost effective and quality consistent manner.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.