PA-22-176, SBIR, Development of a wearable light-based remote monitoring system for early detection of postpartum hemorrhage

项目摘要 迫切需要开发技术，解决可预防的孕产妇死亡原因， 改善产妇保健成果。在美国（US），存在着深刻的种族和民族问题。 孕产妇健康结果的差异（黑人母亲的死亡率比非黑人母亲高出3倍以上） 黑人母亲）。此外，美国是所有高收入国家中孕产妇死亡率最高的国家， 世界上只有两个国家的产妇死亡率在上升。该SBIR项目的重点是解决 产后出血（PPH），定义为分娩后严重出血，因为它是导致产后出血的主要原因。 产妇发病率和死亡率，以及>90%的PPH死亡被认为是可以预防的， 发现和早期治疗。该SBIR项目的产品，孕产妇aRMOR（远程监控光学 阅读器），将是一个腕戴式传感器和集成的移动的应用程序，产科提供者用来检测早期血液 损失（当廉价和容易获得的治疗，如药物和球囊填塞是最 有效）。母体aRMOR使用激光散斑成像来量化外周血流量。母体aRMOR 其工作原理是感知并提醒提供者在早期出血时发生的血流变化， 身体将血液分流到核心以保护重要器官。与失血量的视觉估计不同， 为临床医生提供有关患者血流动力学状态的实时定量信息。目标1 I期SBIR将评估皮肤色素沉着和运动对aRMOR的潜在混杂效应 信号，以确保稳健和公平的设备性能。目标2将建立受试者特异性灌注 范围，以改善个性化出血风险评估。Aim 3将展示一种移动的 在可穿戴式孕产妇aRMOR设备和医疗保健提供者之间进行接口的应用程序， 持续监测PPH。该SBIR项目的第二阶段将专注于开发商业级 器械和临床研究，以证明母体aRMOR对改善健康和降低 与PPH相关的医疗费用。最初的目标客户包括超过3，200家美国产科医院 每年为大约600万患者提供服务。最终，母体aRMOR将为早期PPH设定新的临床标准 诊断使快速治疗成为可能，以防止迟发性出血的毁灭性并发症 包括输血、手术和死亡在内的诊断，目前每年影响数百万母亲。

PROJECT SUMMARY There is an urgent need to develop technologies which address preventable causes of maternal deaths and improve maternal health outcomes. In the United States (US) there exist deeply concerning racial and ethnic disparities in maternal health outcomes (with black mothers experiencing a >3x higher mortality rate than non- black mothers). Furthermore, the US has the highest maternal mortality of any high-income country and is one of only two countries in the world where maternal mortality is rising. This SBIR project is focused on addressing postpartum hemorrhage (PPH), defined as severe bleeding after delivery, because it is a leading cause of maternal morbidity and mortality, and >90% of deaths from PPH are considered preventable with early detection and early treatment. The product of this SBIR project, Maternal aRMOR (remote monitoring optical reader), will be a wrist-worn sensor and integrated mobile app that obstetric providers use to detect early blood loss (when inexpensive and accessible treatments like pharmacologic agents and balloon tamponade are most effective). Maternal aRMOR uses laser speckle imaging to quantify peripheral blood flow. Maternal aRMOR works by sensing and alerting providers to the changes in blood flow that occur in early hemorrhage when the body shunts blood to its core to protect vital organs. Unlike visual estimation of blood loss, Maternal aRMOR provides clinicians with real-time, quantitative information about a patient’s hemodynamic state. Aim 1 of this Phase I SBIR will evaluate the potential confounding effects of skin pigmentation and motion on aRMOR signal, to ensure robust and equitable device performance. Aim 2 will establish a subject-specific perfusion range to improve personalized hemorrhage risk assessment. Aim 3 will demonstrate development of a mobile app that interfaces between the wearable Maternal aRMOR device and healthcare providers to provide continuous monitoring for PPH. Phase II of this SBIR project will focus on development of a commercial-grade device and clinical studies to demonstrate the impact of Maternal aRMOR for improving health and decreasing healthcare cost associated with PPH. Initial target customers include the >3,200 US-based obstetric hospitals who serve ~6M patients annually. Ultimately, Maternal aRMOR will set a new clinical standard for early PPH diagnosis enabling rapid treatments to prevent the devastating complications of delayed hemorrhage diagnosis, including transfusion, surgery, and death, that currently impact millions of mothers each year.