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

SBIR第二阶段：无创胎儿氧合传感硬件和算法的优化

• 批准号: 2025901
• 负责人: Neil Ray
• 金额: $ 99.94万
• 依托单位: Raydiant Oximetry, Inc
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2025901&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Optimization; non

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.

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是在分娩和分娩期间翻译一种新颖的非侵入性胎儿健康监测仪，这将改善护理并降低成本。目前，临床医生依赖于主观、不可靠且具有高假阳性率的监测技术来检测处于缺氧风险（胎儿窘迫）的胎儿，导致医学上不必要的剖宫产率很高。当医学上不必要时，通过剖宫产进行干预会导致本可避免的医疗费用、不必要的孕产妇风险和对新生儿的不良后果。此外，利用当前技术对胎儿健康的误诊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可应用于超过300万例新生儿。 该项目将推进一种新的技术来测量胎儿脉搏中的氧气，创造一种新的方法来确保分娩期间的母亲和孩子的健康。这个小企业创新研究（SBIR）第二阶段项目推进一种新的安全，非侵入性，基于反射的光学方法，用于经腹胎儿脉搏血氧饱和度测量。该方法检测孕妇腹部表面的胎儿信号，并从合并的母胎信号中提取它。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仪。该奖项反映了NSF的法定使命，并已被认为是值得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的支持。