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个增强型脉搏血氧计原型，准备对外演示。该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容积图中提取嵌入的血流动力学信息，包括左心室搏量和心输出量。IDEA将不断发展，以提高诊断范围和准确性。为了评估测量的血流动力学值和趋势的可靠性，将进行扩展评估和初步临床验证研究。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，最终的原型将能够无创测量有价值的血液动力学，并伴有相关的误差条（置信区间），包括搏量和心输出量。其他功能包括抵抗强运动伪影，连续和实时操作，以及利用现有的传感器硬件。该项目更广泛的影响/商业潜力是解决当前技术无法满足的有价值的血液动力学的无创测量。在麻醉、手术和恢复期间，我们的idea增强型脉搏血氧仪可以跟踪患者的情况。S血流动力学演变，警告可能的不良反应或？沉默出血?这在任何标准的监控设备中都无法显示出来。在新生儿病房，它可以监测先天性心脏病或血流不畅的婴儿。在家里，它可以用来监测患有慢性心脏病（美国的头号杀手）的患者，并警告医生出现心律失常和心脏病发作等急性问题。在战场和灾区，我们的设备可以大大提高分诊的速度和准确性，以挽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连续的中风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的数量，并消除对危险的侵入性手术的需要。

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.