NEONATAL OPTICAL NON-INVASIVE BRAIN OXYGENATION MONITOR

在生命中最脆弱的阶段之一，即新生儿期，需要无创、用户友好的脑氧合监测。近红外光谱（NIRS）是一种基于光学的技术，通过测定氧合血红蛋白（deltaHbO2）和脱氧血红蛋白（deltaHb）的相对变化，可用于无创和连续监测脑氧合。近红外光谱是基于使用修改的比尔-朗伯定律来区分deltaHbO2和deltaHb。通过使用低功率激光二极管来影响比尔-朗伯参数的测定，将有可能构建一个小的，相对便宜的近红外装置。该设备将在新生儿中心发现巨大的效用，并持有在其他临床情况下，组织氧合程度的期望应用的承诺。该SBIR的主要目标是1)开发一种近红外光谱系统来监测deltaHb、deltaHbO2和deltaTotalHb，专门用于新生儿监测；2)测试一种新型硬件设计的可行性，与其他可用的近红外光谱系统相比，这种设计将降低成本和功耗；3)验证设备的安全性。建议的商业应用：一种可以无创和连续监测新生儿脑氧变化的仪器将是每个新生儿重症监护病房或医疗设施的有价值的补充。1995年，美国约有390万活产婴儿，其中0.76%的婴儿在出生后第一年死亡。对死亡原因的分析表明，约74%（21,750名婴儿）本可以从脑氧合监测中受益。低出生体重（< 2500克）是与预后不良相关的危险因素。1995年，大约有286 000名低出生体重婴儿，出生第一年的死亡率为6.5%。NlRS提供了改进的新生儿监测能力，以协助医生在护理数十万新生儿和婴儿一年。

There is a need for non-invasive, user-friendly cerebral oxygenation monitoring during one of the most vulnerable stages of life, the neonatal period. Near-infrared spectroscopy (NIRS) is an optically based technique that can be used to non-invasively and continuously monitor brain oxygenation by determining relative changes in oxyhemoglobin (deltaHbO2) and deoxyhemoglobin (deltaHb). NIRS is based upon the use of the modified Beer-Lambert Law to distinguish between deltaHbO2 and deltaHb. By using low power laser diodes to effect the determination of the Beer-Lambert parameters, it will be possible to construct a small, relatively inexpensive NIRS device. This device will find great utility in neonatal centers and holds the promise of applications in other clinical situations where the degree of tissue oxygenation is desired. The primary objectives of this SBIR are 1) to develop a NIRS system to monitor deltaHb, deltaHbO2, and deltaTotalHb, specifically directed to neonatal monitoring, 2) to test the feasibility of a novel hardware design that will reduce cost and power consumption when compared to other available NIRS systems, and 3) to verify equipment safety. PROPOSED COMMERCIAL APPLICATIONS: An instrument that can non-invasively and continuously monitor brain oxygenation changes of the neonate would be a valuable addition to every neonatal intensive care unit or medical facility. In 1995, there were approximately 3.9 million live births in the U.S. Of that, 0.76% of the infants died in the first year [27]. An analysis of the cause of death shows that approximately 74% (21,750 infants) could have benefitted from cerebral oxygenation monitoring. Low birth weight (<2,500 g) is a risk factor associated with poor outcome [24]. In 1995, there were approximately 286,000 live low birth weight infants, with a mortality rate of 6.5% in the first year [27]. NlRS offers improved capability in neonatal monitoring to assist physicians in the care of several hundred thousand neonates and infants a year.