SBIR Phase II: Particle Filtering Technology for Wearable Medical Sensors

这个小型企业创新研究第二阶段项目将开发一种可供外部演示的增强型脉搏血氧仪原型。原型的关键创新将是智能数据提取算法(IDEA)，该算法在第一阶段演示了从光体积图中提取嵌入的血流动力学信息，包括左心室每搏量和心输出量。IDEA将在复杂程度上发展，以增加诊断范围和准确性。将进行扩展评估和初步临床验证研究，以评估测量的血流动力学数值和趋势的可靠性。与医生的密切互动将有助于确定这项新技术的临床用途。如果成功，最终的原型将能够通过相关的误差条(可信区间)实现对有价值的血流动力学的非侵入性测量，包括每搏量和心输出量。其他特点包括抵抗强烈的运动伪影，连续和实时的操作，以及利用现有的传感器硬件。该项目的更广泛的影响/商业潜力是解决现有技术无法满足的有价值的血流动力学的非侵入性测量。在麻醉、手术和恢复期间，我们的IDEA增强型脉搏血氧仪可以全程跟踪患者S的血流动力学变化，警告可能的不良反应或静默出血？不会出现在任何标准的监控设备中。在新生儿病房，它可以监测出生时患有先天性心脏病或血流不畅的婴儿。在国内，它可以用来监测患有慢性心脏病的患者(美国的头号杀手)，并警告医生发生急性问题，如心律失常和心脏病发作。在战场和灾区，我们的设备可以大幅提高分诊的速度和准确性，拯救受伤士兵和受害者的生命。许多其他医疗实践将受益于使用无创和持续的每搏量和其他血液动力学监测，以扩大患者护理区域可用的重要信息量，并消除对高风险侵入性手术的需求。

This Small Business Innovation Research Phase II project will develop an enhanced pulse oximeter prototype ready for external demonstration. The key innovation of the prototype will be the Intelligent Data Extraction Algorithm (IDEA), which during Phase I demonstrated extraction of embedded hemodynamic information from photoplethysmograms, including left-ventricular stroke volume and cardiac output. IDEA will evolve in sophistication to increase diagnostic range and accuracy. Both extended evaluation and preliminary clinical validation studies will take place in order to assess the reliability of measured hemodynamic values and trends. Close interaction with doctors will help define clinical uses for this new technology. If successful, the final prototype will enable the noninvasive measurement of valuable hemodynamics with associated error bars (confidence intervals) including stroke volume and cardiac output. Other features include resistance to strong motion artifacts, continuous and real-time operation, and utilization of existing sensor hardware.The broader impact/commercial potential of this project is to solve noninvasive measurement of valuable hemodynamics that cannot be met with current technology. During anesthesia, surgery, and recovery, our IDEA-enhanced pulse oximeter can track the patient?s hemodynamic evolution throughout, warning against possible adverse reactions or ?silent hemorrhages? that do not show up in any standard monitoring equipment. In the neonatal ward, it can monitor babies born with congenital heart disease or poor blood flow. At home, it can be used to monitor patients with chronic heart conditions (the top killer in the US) and warn doctors about developing acute problems such as arrhythmias and heart attacks. In the battlefield and disaster areas, our device can dramatically improve the speed and accuracy of triage to save the lives of injured soldiers and victims. Many other medical practices would benefit from the use of noninvasive and continuous stroke volume and other hemodynamic monitoring to expand the amount of vital information available at the patient care area and eliminate the need for risky invasive procedures.