SBIR Phase I: A Soft, Tip-Growing, Self-Deploying Endotracheal Tube that Enables Visualization-Free Intubation

这项小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是一种新型技术，可以主动插管气道通道，同时降低因困难或失败的紧急程序而引起的并发症风险。 这种手术通常用于遭受创伤、缺氧或心脏骤停的患者。所提出的软机器人设备从其尖端延伸，充满主动机械智能，以自主导航上气道，从而实现无可视化的自我部署。 所提出的技术与当前的半刚性器械形成对比，当前的半刚性器械由用户从器械的近端基座推动。该项目旨在提高插管成功率，减少并发症，并减轻与气道管理失败相关的全系统成本。此外，该技术旨在减少插管患者所需的导航和放置技能，使现场人员能够安全和轻松地提供气道管理。该产品旨在从每年20亿美元的全球气道设备市场中分得一杯羹，最终通过更大的用户采用和用例选项来扩大市场。这一小型企业创新研究（SBIR）第一阶段项目旨在展示自展开插管设备的概念验证。将开发一种软机器人系统，旨在实现90%的首次插管成功率。技术措施包括在有效压力（20 kPa）下以快速方式（15 s）展开，与专家引导喉镜的组织力（15 N）相当，与用户技能无关。在第一阶段，将进一步推进设计和工程，以实现可行性测试和产品验证。 将通过迭代尸体测试优化设计的有效性、安全性和速度。该项目的完成将产生一个可操作的、尖端生长的、用于气道插管的软机器人原型，该原型考虑了人类的可变性。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 a novel technology that actively intubates airway passages while reducing the risks of complications arising from difficult or failed emergency procedures. Such a procedure is often used with patients suffering from trauma, hypoxia, or cardiac arrest. The proposed soft robotic device extends from its tip, imbued with active mechanical intelligence to autonomously navigate the upper airway enabling visualization-free self-deployment. The proposed technology contrasts with current semi-rigid devices, which are pushed from the proximal base of the device by the user. This project aims to improve intubation success rates, reduce complications, and mitigate system-wide costs associated with failed airway management. Furthermore, the technology aims to reduce the navigation and placement skill sets needed to intubate patients, enabling the potential option for field personnel to safely and readily provide airway management. The product aims to capture a portion of the $2 billion annual global airway devices market, ultimately expanding the market through greater user adoption and use case options.This Small Business Innovation Research (SBIR) Phase I project aims to demonstrate proof of concept for a self-deploying intubation device. A soft robotics system will be developed that aims to achieve a 90% first-pass intubation success rate. The technical measures include deploying at an effective pressure (20kPa), in a rapid manner (15s), with comparable forces to the tissue (15N) as expert-guided laryngoscopes, agnostic to user skill sets. During Phase I, design and engineering will be furthered to enable feasibility testing and product validation. The design will be optimized for efficacy, safety, and speed via iterative cadaver testing. Completion of this project will yield an operational, tip-growing, soft robotic prototype for airway intubation accounting for human variability.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.