Noninvasive Optoacoustic Monitoring of Intrapartum Fetal Cerebral Hypoxia

描述(申请人提供)：分娩期间胎儿窘迫(包括脑缺氧)是死亡或严重神经系统并发症(如脑瘫)的危险因素。 在美国，每年有超过400万名婴儿出生，他们是分娩期间的监测对象。虽然胎心率监测提供了胎儿氧合的间接指标，但到目前为止，还没有商业化的监护仪可以直接监测胎儿脑血流的充分性。因此，对胎儿脑氧合进行非侵入性测量的需求尤为迫切。在这个SBIR第一阶段的应用中，我们建议为我们开发的用于监测创伤性脑损伤患者脑氧合的原型系统开发一个胎儿界面。该系统将通过开放的前门或薄薄的颅骨，在分娩后期提供准确、非侵入性的胎儿脑静脉血氧饱和度测量。脑静脉血氧饱和度是重型颅脑损伤患者的一种公认的监测手段，它可以一次性评估脑血流量和脑血氧含量满足脑氧需求的能力。在我们之前的工作中，我们描述了一种光声设备，用于无创监测脑静脉血氧饱和度，并在实验动物、成年志愿者和极低出生体重新生儿中进行了测试。我们的光声系统可以精确测量血氧饱和度(R2=0.990)，特别是在上矢状窦，因为高(光学)对比度和高(超声)分辨率允许直接探测血管。拟议项目的具体目标是：1)开发一种与我们的光声平台兼容的临床原型患者界面，用于晚期分娩的胎儿；以及2)在晚期分娩的胎儿体内测试该系统。在拟议的项目实施后，我们将建造和测试可用于制造的原型，并确保510k获得FDA的批准。

DESCRIPTION (provided by applicant): Fetal distress (including cerebral hypoxia) during labor represents a risk factor for death or severe neurologic complications (e.g., cerebral palsy). More than 4,000,000 babies are born annually in the United States and are candidates for monitoring during labor. Although fetal heart rate monitoring provides an indirect indicator of fetal oxygenation, to date, there are no commercially available monitors that directly monitor the adequacy of fetal cerebral blood flow. Thus, the need for noninvasive measurement of cerebral oxygenation in fetuses is particularly pressing. In this SBIR Phase I application, we propose to develop a fetal interface for a prototype system that we have developed for monitoring cerebral oxygenation in patients with traumatic brain injury. The system will provide accurate, noninvasive measurement of cerebral venous blood oxygen saturation in fetuses during late stage labor through the open anterior fontanelle or through the thin cranial bones. Cerebral venous oxygen saturation, an established monitor in patients with severe traumatic brain injury, provides in a single number an assessment of the ability of cerebral blood flow and cerebral blood oxygen content to meet cerebral oxygen requirements. In our previous works, we described, built and tested in experimental animals, adult volunteers and very-low-birth-weight neonates an optoacoustic device for noninvasive monitoring of cerebral venous oxygen saturation. Our optoacoustic system provides accurate measurement of oxygen saturation (R2 = 0.990), specifically in the superior sagittal sinus, because high (optical) contrast and high (ultrasound) resolution permit direct probing of blood vessels. The specific aims of the proposed project are: 1) to develop for use in fetuses during late stage labor a clinical prototype patient interface that is compatible with our optoacoustic platform; and 2) to test the system in vivo in fetuses during late-stage labor. After implementation of the proposed project, we will build and test a manufacturing-ready prototype and secure 510k clearance from the FDA.