SBIR Phase I:Design and optimization of non-invasive fetal oxygenation sensing hardware and algorithm

SBIR第一期：无创胎儿氧合传感硬件和算法的设计和优化

• 批准号: 1843135
• 负责人: Neil Ray
• 金额: $ 22.5万
• 依托单位: Raydiant Oximetry, Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1843135&HistoricalAwards=false
• 关键词: SBIR; Phase; Design; optimization; non

This SBIR Phase I project is developing a breakthrough technology to non-invasively monitor fetal oxygen levels in utero, to enable the more accurately detection of fetuses in distress and facilitate safer births for mothers and babies. Currently, obstetricians struggle with a 50-year old monitoring technology, which reports fetal heart rate and maternal contractions, and that is associated with an 89% false positive rate for detecting babies in distress. This is a major contributor to high cesarean section rates worldwide and up to 40% in some US hospitals. Because of the costs, risks for mothers and negative implications for babies' health, C-section rates are coming under scrutiny from insurers and accreditors, however, clinicians lack the means to accurately identify oxygenation starvation and, to date, no non-invasive means of directly measuring fetal oxygenation has been developed. Raydiant's system builds off traditional pulse oximetry and will employ safe levels of light, through the mother's abdomen, to monitor fetal pulse and report oxygen saturation, the crucial, but missing diagnostic. This technology will be applicable to over 2.9 million births per year in the US as an enhancement to traditional monitoring whenever a heart rate signal of concern is observed. Both the absolute oxygenation value and its trend over time will enable more informed decision making throughout the birth process.This project pushes the fundamental boundaries of pulse oximetry and bio-photonics. Unlike traditional finger pulse oximetry, sensing non-invasively through the maternal abdomen presents a body in a body problem, where the fetal pulse signal is orders of magnitude weaker than and intertwined with the maternal. Photons are scattered and absorbed by multiple tissue layers and there are tradeoffs between signal strength, noise and the ratio of fetal to maternal signal. Non-homogeneities from subject to subject makes calibration difficult. Addressing these challenges will require innovation in photonics hardware and signal processing and this proposal has a three specific aims: the development of a specific sensor hardware architecture that will facilitate detection of the fetal signal; development of Raydiant's algorithm to separate fetal from maternal signal, reject noise and report saturation; and validation of the combined system in a pregnant animal model, where fetal oxygenation levels are actively controlled and compared to the device reading. This proposal encompasses developing a second generation prototype system and represents critical technology de-risking aiming towards a commercial system for integration with current monitoring technology and clinical practice.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.

SBIR 第一阶段项目正在开发一项突破性技术，用于无创监测子宫内胎儿的氧气水平，从而能够更准确地检测胎儿是否处于困境，并促进母亲和婴儿的安全分娩。目前，产科医生正在努力使用已有 50 年历史的监测技术，该技术可报告胎儿心率和母体宫缩，且检测遇险婴儿的误报率为 89%。这是全球剖腹产率居高不下的主要原因，在美国一些医院剖腹产率高达 40%。由于成本、母亲面临的风险以及对婴儿健康的负面影响，剖腹产率正在受到保险公司和认证机构的严格审查，然而，临床医生缺乏准确识别氧合不足的方法，而且迄今为止，还没有开发出直接测量胎儿氧合的非侵入性方法。 Raydiant 的系统建立在传统脉搏血氧仪的基础上，将采用安全水平的光，穿过母亲的腹部，监测胎儿脉搏并报告氧饱和度，这是至关重要但缺失的诊断。这项技术将适用于美国每年超过 290 万的新生儿，作为对传统监测的增强，无论何时观察到令人担忧的心率信号。绝对氧合值及其随时间的变化趋势将有助于在整个分娩过程中做出更明智的决策。该项目突破了脉搏血氧测定法和生物光子学的基本界限。与传统的手指脉搏血氧测定法不同，通过孕妇腹部进行非侵入式传感会出现身体问题，胎儿脉搏信号比孕妇的脉搏信号弱几个数量级，并且与孕妇交织在一起。光子被多个组织层散射和吸收，并且信号强度、噪声以及胎儿与母体信号的比率之间存在权衡。对象之间的非同质性使得校准变得困难。解决这些挑战需要光子硬件和信号处理方面的创新，该提案有三个具体目标：开发有助于检测胎儿信号的特定传感器硬件架构；开发 Raydiant 算法以将胎儿信号与母体信号分离、抑制噪声并报告饱和度；并在怀孕动物模型中验证组合系统，其中胎儿氧合水平受到主动控制并与设备读数进行比较。该提案包括开发第二代原型系统，代表了关键技术去风险，旨在实现与当前监测技术和临床实践相结合的商业系统。该奖项反映了 NSF 的法定使命，并通过使用基金会的智力优点和更广泛的影响审查标准进行评估，被认为值得支持。