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

这项小企业创新研究（SBIR）第二阶段项目的更广泛影响/商业潜力是翻译一种新型的、无创的胎儿健康监护仪，用于分娩和分娩过程，这将改善护理并降低成本。目前，临床医生依靠主观、不可靠、假阳性率高的监测技术来检测胎儿缺氧（胎儿窘迫）风险，导致医学上不必要的剖宫产率很高。在医学上不必要的情况下，通过剖宫产进行干预会产生本可避免的医疗费用、不必要的产妇风险和对新生儿的不利后果。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将适用于300多万新生儿。该项目将推进一项测量胎儿脉搏含氧量的新技术，创造一种确保分娩期间母婴健康的新方法。这项小企业创新研究（SBIR）二期项目提出了一种新的安全、无创、基于反射的经腹胎儿脉搏血氧测量光学方法。该方法在母体腹部表面检测胎儿信号，并从母胎联合信号中提取胎儿信号。该项目将进行验证和验证测试，以整合信号处理、生物光子学和脉搏血氧测定。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识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.