Breathing Tube Position and Patency Monitoring System

描述(由申请人提供)： 该项目的长期目标是将一种气管内管(ETT，呼吸管)商业化，该管结合了一种可以提供大量临床相关信息的技术，以帮助进行呼吸道管理。该系统由一个低成本的一次性ETT组成，其中包含几个连接到嵌入式微处理器的微型传感器。该系统可以提供：在插管期间(在呼吸或非呼吸患者中)正确放置导管的即时确认；通过声带将ETT插入深度量化到毫米以内；ETT管腔内部分或全部阻塞的位置和程度；ETT直径与气管匹配的适当性；以及在吸气时ETT管腔内吸引导管尖端的位置。预计这一呼吸道管理工具将通过持续监测ETT的状况和位置，为插管患者建立一个新的护理标准，从而确保呼吸道畅通和完整。临床使用这些导管可能会降低与ETT使用相关的直接成本(例如，胸部X光检查以确认导管放置、预防性吸引术)和间接成本(例如，由于发病率和死亡率造成的成本)。该系统的原型可同样适用于成人和婴儿大小的ETT，已在动物和人类婴儿的初步研究中进行了评估，取得了良好的结果。然而，该原型还不够坚固或足够微型，不能用于临床，因此在取得进展之前需要进行更多的研究。第一阶段的主要目标是进行体外研究，以设计和开发一个最佳的微型系统，同时确保该设计能够以低成本大规模生产。成功实现这一目标将大大降低与第二阶段开发可靠和低成本的商业系统相关的技术风险。

DESCRIPTION (provided by applicant): The long-term objective of this project is to commercialize an endotracheal tube (ETT, breathing tube) incorporating a technology which can provide a multitude of clinically relevant information to aid in airway management. The system consists of a low-cost, disposable ETT containing several miniature sensors that are connected to an embedded microprocessor. The system can provide: instantaneous confirmation of proper tube placement during intubation (in breathing or non-breathing patients); quantification of ETT insertion depth past the vocal folds to within millimeters; location and degree of partial or full obstructions within the ETT lumen; appropriateness of ETT diameter fit to the trachea; and location of a suction catheter tip within the ETT lumen during suctioning. It is expected that this airway management tool will establish a new standard of care for the intubated patient by continuously monitoring the condition and position of ETTs thereby ensuring a clear and intact airway. Clinical use of these tubes can potentially reduce both the direct costs (e.g. chest x-rays to confirm tube placement, prophylactic suctioning procedures) and indirect costs (e.g. resulting from morbidity and mortality) associated with ETT use. A prototype of the system, which can be applied equally to adult and infant sized ETTs, has been evaluated in preliminary animal and human infant studies with excellent results. However, the prototype is not robust or miniature enough for clinical use and thus requires additional research before moving forward. The key phase I aim is to conduct in vitro studies to design and develop an optimal miniature system while ensuring that the design can be mass produced at a low cost. Successful completion of this aim will significantly reduce the technology risk associated with the phase II development of a reliable and low-cost commercial system.