Integrated Fiber Optic Sensor Umbilical Catheter for Blood Gas Monitoring

用于血气监测的集成光纤传感器脐导管

• 批准号: 8831977
• 负责人: Jesus Delgado Alonso
• 金额: $ 22.5万
• 依托单位: INTELLIGENT OPTICAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-25 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8831977
• 关键词: Address; Adopted; Animal Model; Animal Testing; Animals; Area; Arteries; Bicarbonates; Biocompatible; Blood; Blood Gas Analysis; Blood gas; Calibration; Carbon Dioxide; Caring; Catheterization; Catheters; Central Artery; Cessation of life; Clinical Research; Clinical Trials; Communities; Critical Care; Critical Illness; Data; Devices; Dimensions; Elements; Event; Fiber Optics; Funding; Gases; Goals; Gold; Hemorrhage; Incidence; Infant; Infection; Intervention; Laboratories; Length; Life; Measurement; Measures; Medical; Modality; Modeling; Monitor; Morbidity - disease rate; Morphologic artifacts; Movement; Newborn Infant; Optics; Oxygen; Pain; Patients; Performance; Phase; Premature Infant; Procedures; Process; Reaction Time; Safety; Sampling; Side; Spasm; Spottings; Sterilization; Structure of umbilical artery; System; Temperature; Testing; Time; United States Centers for Medicare and Medicaid Services; Work; base; commercialization; cost; data acquisition; design; human subject; improved; meetings; mortality; neonate; non-invasive monitor; novel; phase 1 study; premature; prevent; public health relevance; sensor; standard of care; success; tool

 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.

 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，但对于脆弱的极早产儿尤为重要，即使是适当干预的最小延迟也可能是生与死的区别。传统上进行的血气的间歇监测仅提供对患者的生理病理状态的抽查;结果通常延迟于触发血气分析的实际事件，并且除了易患医源性感染之外，该过程本身是痛苦的，并且随着时间的推移，可能导致显著的失血。连续和非侵入性监测对于监测血气是优选的，但是当前的非侵入性连续模态具有显著的局限性。这导致了开发非侵入性和连续血气监测系统的几次尝试，但是没有成功，并且目前不存在满足连续血气监测系统的准确性、精确度和安全性需求的市售系统。一个准确、精确和本质安全的系统，利用常规进行的血管内导管插入术（如脐动脉导管插入术-患病新生儿的护理标准） 连续获得血气测量将是监测入住NICU的危重新生儿的重要进展。为了满足这一需求，我们建议开发一种集成光纤传感器脐（ISUM）导管，用于新生儿血气监测。ISUM导管将通过解决“经典”血管内传感器探头中显示的缺陷来填补连续血液分析的技术空白，并将利用NICU中大多数新生儿接受至少一个血管内导管的事实，其中脐动脉导管插入术是最常进行的程序之一。传感器和导管将被设计为用于该特定应用的集成单元，并且与先前描述的血管内探头相比将具有以下优点：（1）大面积气体传感器，消除探头放置或移动伪影;（2）双氧传感器和数据融合，提高可靠性;（3）将集成传感器导管放置在中央动脉中将消除血管痉挛;（4）无需校准的传感器，没有数据采集时间的延迟;以及（5）降低了成本，因为高度可重复的传感器元件可以以数百个批量生产。完成拟定目标后，经确认的ISUM导管将可用于人体受试者试验。一旦实现本申请中提出的里程碑，我们将通过以下方式迅速将ISUM导管商业化：1）申请临床试验的II期资金; 2）启动FDA 510（k）提交程序; 3）接洽投资者进行商业化。