Integrated Fiber Optic Sensor Umbilical Catheter for Blood Gas Monitoring

 描述(由申请人提供)：动脉血气监测对于任何患病婴儿的管理都是必不可少的，但对脆弱的、极早产儿尤其重要，因为即使是适当干预的最小延迟也可能是生死攸关的问题。传统上进行的间歇性血气监测只能提供对患者生理病理状态的抽查；结果往往与触发血气分析的实际事件延迟，而且这一过程除了容易发生医源性感染之外，本身也很痛苦，随着时间的推移，可能会导致大量失血。连续和非侵入性监测是监测血气的首选方法，但目前的非侵入性连续监测手段有明显的局限性。这导致了开发非侵入性和连续的血气监测系统的几次尝试，但都没有成功，并且目前还没有商业上可用的系统来满足连续的血气监测系统的准确性、精密度和安全性需求。一种准确、精确和本质安全的系统，它利用常规的血管内插管(如脐动脉插管-患病新生儿的护理标准) 连续监测血气将是监测NICU危重新生儿的重要进展。为了满足这一需求，我们建议开发一种用于新生儿血气监测的集成光纤传感器脐带(ISUM)导管。ISUM导管将通过解决“经典”血管内传感器探头所显示的缺陷，填补连续血液分析的技术空白，并将利用这样一个事实，即NICU中的大多数新生儿至少接受一条血管内导管，脐动脉插管是最常见的操作之一。针对这一具体应用，传感器和导管将被设计为一体，与前面描述的血管内探头相比，它将具有以下优势：(1)大面积气体传感器，消除了探头放置或移动伪影；(2)双氧传感器和数据融合，提高了可靠性；(3)将集成的传感器导管放置在中央动脉将消除血管痉挛；(4)无需校准的传感器，数据采集时间不会延迟；(5)降低了成本，因为可以成批生产数百个高度可重复的传感器元件。完成拟议的目标将产生一种经过验证的ISUM导管，可用于人体试验。一旦达到本申请中提出的里程碑，我们将迅速采取行动，通过以下方式将ISUM导管商业化：1)申请临床试验第二阶段资金；2)启动FDA 510(K)提交程序；3)接洽投资者进行商业化。

 DESCRIPTION (provided by applicant): The monitoring of arterial blood gases is essential for the management of any sick infant, but is especially important in vulnerable, extremely premature infants where even a minimal delay in appropriate interventions can be the difference between life and death. Intermittent monitoring of blood gases, as is traditionally performed, provides only a spot check of the physio-pathological status of the patient; the results are often delayed from the actual event triggering blood gas analysis, and the procedure, besides predisposing to iatrogenic infections, in itself is painful and, over time, can result in significat blood loss. Continuous and non-invasive monitoring is preferable for monitoring blood gases, but current non-invasive continuous modalities have significant limitations. This has led to several attempts to develop a non-invasive and continuous blood gas monitoring system, but without success, and at present no commercially available system exists that fulfills the accuracy, precision, and safety needs of a continuous blood gas monitoring system. An accurate, precise, and intrinsically safe system that exploits routinely performed intravascular catheterization (such as umbilical artery catheterization - the standard of care for sick neonates) to obtain blood gas measurements continuously would be an important advance in monitoring critically ill neonates admitted to NICUs. To address this need, we propose to develop an integrated fiber optic sensor umbilical (ISUM) catheter for blood gas monitoring in neonates. The ISUM catheter will fill the technological gap in continuous blood analysis by addressing the deficiencies shown in "classical" intravascular sensor probes, and will take advantage of the fact that most newborns in NICUs receive at least one intravascular catheter, with umbilical arterial catheterization being one of the most commonly performed procedures. The sensor and the catheter will be designed as an integrated unit for this specific application, and will have the following advantages over previously described intravascular probes: (1) large area gas sensors, eliminating the probe placement or movement artifacts; (2) dual oxygen sensor and data fusion, improving reliability; (3) placement of the integrated sensor catheter in a central artery will eliminate vessel spasms; (4) calibration-free sensors, with no with no delay in data acquisition time; and (5) reduced cost, since highly repeatable sensor elements can be produced in batches of hundreds. Completion of the proposed aims will result in a validated ISUM catheter ready for human subject testing. As soon as the milestones proposed in this application are achieved, we will move quickly to commercialize the ISUM catheter by 1) applying for Phase II funding for clinical trials; 2) starting the process for an FDA 510 (k) submission; 3) approaching investors for commercialization.