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

PA-22-176，SBIR，开发可穿戴式光基远程监测系统，用于产后出血的早期检测

• 批准号: 10821955
• 负责人: Kelsey Ross Mayo
• 金额: $ 29.59万
• 依托单位: ARMOR MEDICAL INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2024-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10821955
• 关键词: PA; 22; 176; SBIR; Development

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.

项目概要 迫切需要开发解决孕产妇死亡可预防原因的技术 改善孕产妇健康结果。在美国，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 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之一 世界上仅有两个孕产妇死亡率上升的国家。该 SBIR 项目的重点是解决 产后出血（PPH），定义为产后严重出血，因为它是产后出血的主要原因 产妇发病率和死亡率，以及超过 90% 的 PPH 死亡被认为可以通过早期预防 发现和早期治疗。本次SBIR项目的产品Maternal aRMOR（远程监控光学 阅读器），将是产科提供者用来检测早期血液的腕戴式传感器和集成移动应用程序 损失（当药物制剂和球囊填塞等廉价且容易获得的治疗方法是最有效的 有效的）。母体 aRMOR 使用激光散斑成像来量化外周血流量。母体装甲 其工作原理是感测并提醒提供者注意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。与目视估计失血量不同，母体 aRMOR 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。这个目标1 第一阶段 SBIR 将评估皮肤色素沉着和运动对 aRMOR 的潜在混杂影响 信号，以确保稳健且公平的设备性能。目标 2 将建立特定于受试者的灌注 范围以改善个性化出血风险评估。目标 3 将展示移动设备的开发 应用程序连接可穿戴式Maternal aRMOR 设备和医疗保健提供者，以提供 持续监测 PPH。该 SBIR 项目的第二阶段将重点开发商业级 设备和临床研究证明母体 aRMOR 对改善健康和减少体重的影响 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 每年为约 600 万患者提供服务。最终，Maternal aRMOR 将为早期 PPH 制定新的临床标准 诊断有助于快速治疗，以预防迟发性出血的破坏性并发症 诊断，包括输血、手术和死亡，目前每年影响数百万母亲。