SBIR Phase II: Optimization of non-invasive fetal oxygenation sensing hardware and algorithm

这个小企业创新研究 (SBIR) 第二阶段项目的更广泛的影响/商业潜力是转化一种新型、非侵入性的分娩过程中胎儿健康监测仪，这将改善护理并降低成本。目前，临床医生依靠主观、不可靠且假阳性率较高的监测技术来检测有缺氧风险（胎儿窘迫）的胎儿，导致医学上不必要的剖腹产率很高。当医学上没有必要时，剖腹产干预会产生可避免的医疗费用、不必要的孕产妇风险以及对新生儿的不良后果。此外，当前技术对胎儿健康的误诊会导致昂贵的医疗过失诉讼。仅在美国，胎儿脉搏血氧仪每年就适用于超过 300 万新生儿。 该项目将推进一种测量胎儿脉搏中氧气的新技术，创造一种新方法来确保母亲和孩子在分娩过程中的健康。这个小型企业创新研究（SBIR）第二阶段项目提出了一种新的安全、非侵入性、基于反射的光学方法，用于经腹部胎儿脉搏血氧测定。该方法检测母体腹部表面的胎儿信号，并从母胎组合信号中提取该信号。该项目将进行验证和确认测试，以集成信号处理、生物光子学和脉搏血氧测定法。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力价值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 this Small Business Innovation Research (SBIR) Phase II project is translation of a novel, non-invasive monitor for fetal health during labor and delivery that will improve care and reduce cost. Currently, clinicians rely on monitor technologies that are subjective, unreliable and have high false positive rates for detecting the fetus at risk of hypoxia (fetal distress), resulting in high rates of medically unnecessary cesarean deliveries. When medically unnecessary, intervention by cesarean delivery incurs avoidable healthcare cost, unwarranted maternal risk and adverse consequences for newborns. Further, misdiagnosis of fetal health with current technologies results in costly medical negligence litigation. Fetal pulse oximetry would be applicable to over 3 million births per year in the United States alone. This project will advance a new technology to measure oxygen in the fetus's pulse, creating a new method to ensure health of mother and child during delivery.This Small Business Innovation Research (SBIR) Phase II project advances a new safe, non-invasive, reflectance-based optical method for transabdominal fetal pulse oximetry. This method detects the fetal signal at the surface of the maternal abdomen and extracts it from the combined maternal-fetal signal. This project will conduct verification and validation tests to integrate signal processing, biophotonics, and pulse oximetry.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.