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

SBIR 第二阶段：新型呼吸袋-瓣膜-面罩复苏器

• 批准号: 2242331
• 负责人: Adam Scott
• 金额: $ 99.99万
• 依托单位: COMPACT MEDICAL SOLUTIONS LLC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-11-01 至 2025-10-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2242331&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Novel; Respiratory

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.

该小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力是一种新型器械，可减少急救人员在使用袋阀面罩（BVM）手动复苏器时对患者的伤害。BVM在院前和医院环境中由急救医务人员每天使用，为重症患者提供空气。它们的基本设计已经存在了60多年，经常被滥用，导致损伤，并发症或偶尔致命的肺损伤。该项目将完成一种新型BVM的开发，该BVM可精确控制交付的体积和压力，旨在重新定义停滞的BVM市场，预计到2025年，该市场每年将超过7.5亿美元。通用气囊-阀门-面罩复苏器，使急救提供者能够提供根据患者体型定制的空气量和压力。目前的设备通常被误用，即使是受过高度训练的医务人员，也会导致过度换气、气压伤和偶尔的死亡。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正确地使用器械。第二个目标是在美国批准的标准范围内解决可制造性和测试要求。最后，第三个目标是建立装配过程和初始质量控制测试，以确保以成本效益和质量一致的方式进行大规模生产。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。