NEONATAL OPTICAL NON-INVASIVE BRAIN OXYGENATION MONITOR

描述(申请人的摘要逐字)：需要非侵入性、 在最脆弱的期间进行人性化的脑氧合监测 生命的各个阶段，新生儿期。近红外光谱(NIRS)是一种 基于光学的技术，可用于非侵入性和连续的 通过测定氧合血红蛋白的相对变化来监测脑氧合 (Delta HBO2)和脱氧血红蛋白(Delta Hb)和绝对脑氧 饱和(CrSO2)。增量HbO2和增量Hb的总和给出了 总血红蛋白(增量总Hb)。近红外光谱是基于使用修改后的 区分增量HbO2和增量Hb的Beer-Lambert定律。通过使用LOW 功率激光二极管，用于确定Beer-Lambert参数， 这将有可能建造一种小型的、相对便宜的近红外设备。 这一设备将在新生儿中心得到极大的实用，并有望 在其他临床情况下的应用，其中组织的程度 需要充氧。 此第二阶段SBIR提案的主要目标是：1)开发低成本的 成本近红外系统用于监测Delta Hb、Delta HBO2、Delta TotalHb和CrSO2， 专门针对新生儿监测，2)证明其临床实用性 新生儿ICU中的近红外光谱，以及3)对照血液验证近红外光谱参数 从新生儿的颈内静脉采集的样本。 建议的商业应用： 一种可以无创、连续监测新生儿脑氧合变化的仪器将是每个新生儿重症监护病房或医疗机构的宝贵补充。1995年，美国有大约390万名活产婴儿，其中0.76%的婴儿在第一年死亡[27]。死因分析表明，约74%(21,750名婴儿)可能受益于脑氧合监测。低出生体重(2,500克)是与不良结局相关的风险因素[24]。1995年，约有28.6万名低出生体重儿存活，第一年死亡率为6.5%[27]。NIRS提供了改进的新生儿监测能力，以帮助医生每年护理数十万名新生儿和婴儿。

DESCRIPTION (Applicant's abstract verbatim): 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 (delta HbO2) and deoxyhemoglobin (delta Hb) and absolute cerebral oxygen saturation (CrSO2). The summation of deltaHbO2 and delta Hb give changes in total hemoglobin (delta TotalHb). NIRS is based upon the use of the modified Beer-Lambert Law to distinguish between deltaHbO2 and delta Hb. 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 Phase II SBIR proposal are 1 ) to develop a low cost NIRS system to monitor delta Hb, delta HbO2, delta TotalHb, and CrSO2, specifically directed to neonatal monitoring, 2) to prove the clinical utility of NIRS in a neonatal ICU, and 3) to verify the NIRS parameters against blood samples drawn from the internal jugular vein of the neonate. PROPOSED COMMERCIAL APPLICATION: 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 ~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 ~74% (21,750infants) could have benefited from cerebral oxygenation monitoring. Low birth weight (<2,500g) is a risk factor associated with poor outcome [24]. In 1995, there were ~286,000 live low birth weight infants, with a mortality rate of 6.5% in the first year [27]. NIRS offers improved capability in neonatal monitoring to assist physicians in the care of several hundred thousand neonates and infants a year.