STTR Phase I: A Novel Device for Accurate Intrapartum Fetal Health Monitoring

拟议的STTR第一阶段项目的更广泛的影响/商业潜力是建立一种用于胎儿健康监测的非侵入性医疗设备，以帮助产科医生避免不必要的剖腹产手术(剖腹产)。尽管剖腹产的成本很高，而且有明确的证据表明剖腹产有健康风险，但许多婴儿是通过剖腹产出生的。剖腹产率高，以及相关的额外费用和健康并发症，部分原因是现有的电子胎儿监护仪不准确，会产生许多胎儿窘迫的错误警报。该项目的目标是通过开发一种非侵入性设备来解决这一问题，以便产科医生可以方便和准确地评估分娩期间的胎儿健康。拟议的STTRI期项目旨在推动一项突破性技术，用于无创、经腹部测量胎儿动脉血氧饱和度(FSpO2)。其基本工作原理是在腹部照射两个特定的近红外波长，然后通过皮肤感知少量的漫反射散射光。这些测量的信号需要进行处理，以校正母亲的贡献，并推断由于胎儿动脉搏动而产生的强度变化。拟议的项目将推进原型的开发，并展示在低氧胎儿动物模型中安全、稳健和可靠的经腹FSpO2测量的可行性。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of the proposed STTR Phase I project is to build a non-invasive medical device for fetal health monitoring to assist obstetricians in avoiding unnecessary cesarean-section surgeries (C-Sections). Despite significant cost and clear evidence of health risks associated with C-Sections, many infants are delivered via C-Sections. The high C-section rate and the associated additional cost and health complications result in part from inaccuracy of existing electronic fetal monitors, which generate many false alarms for fetal distress. The goal of this project is to address this problem by developing a non-invasive device so obstetricians may conveniently and accurately assess fetal health during labor and delivery.The proposed STTR Phase I project is to advance a breakthrough technology for non-invasive, transabdominal measurement of fetal arterial blood oxygen saturation (FSpO2). The underlying principle of operation is to shine light in the abdominal area at two specific near-infrared wavelengths and subsequently sense the small amount of diffusely scattered light transcutaneously. These measured signals require processing to correct for the maternal contribution and to infer intensity variations due to pulsation of fetal arteries. The proposed project will advance the development of a prototype and demonstrate feasibility of safe, robust and reliable transabdominal FSpO2 measurement in hypoxic fetal animal models.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.