An Instantaneous Ultrasonic Personal Blood Pressure Monitor

 描述(申请人提供)：血压(BP)是包括高血压在内的健康的关键生命体征。然而，临床实践在很大程度上仅限于笨拙、不方便的手臂袖口，只提供时间点测量。高通量筛查以及个人健康监测将受益于简单的BP监护仪，该监护仪无需培训即可获得准确的测量结果--理想情况下只需几秒钟而不是几分钟--并包括电子健康记录(EHR)集成，以最大限度地减少患者报告错误和不合规。该项目的总体目标是使用超声波，特别是声辐射力脉冲(ARFI)技术，开发一种易于使用、无袖带、非侵入性的超声波血压监测仪，由紧凑的传感器垫和读数组成。在动脉上放置与皮肤接触的垫子将立即提供自我校准的准确血压。其工作原理类似于传统的手臂袖带，它依赖于通过声学观察动脉壁偏转来响应动脉内压和外部施加的袖带压力之间的差异；然而，该项目将使用超声波能量在动脉壁上施加高度局部化但安全的ARFI压力脉冲，并测量由压差产生的微观偏转。此外，超声波的高速将允许在几秒钟内方便地评估血压。第一个目标是在商业超声试验台上演示超声压力测量方法，方法是：开发算法，使用测量的位移来非侵入性跟踪脉搏波形，以响应ARFI脉冲；校准ARFI脉冲的压力强度；报告充满液体和血液的动脉模体的绝对收缩和舒张期等效压力，并根据IEEE 1708-2014无袖带血压装置标准对该方法进行人体临床评估。第二个目标将寻求用低成本的电容式微机械超声换能器(非常适合于负担得起的个人健康监测应用)取代压电试验台换能器，同样地，根据IEEE标准进行临床评估。最终目标是将试验台转化为带有专门设计的读数单元的原型仪器，整合EHR接口，并最终进行临床研究，在低资源环境下评估完整的健康监测系统。该项目与美国卫生与公众服务部的“百万心脏计划”特别相关，可能会触及百万心脏逻辑模型的多个方面：改进大规模流行病学研究的测量和报告；提高正在使用的高血压药物的管理有效性；减少使用的麻烦和障碍；以及支持美国和印度的进一步动态研究。

 DESCRIPTION (provided by applicant): Blood pressure (BP) is a critical vital sign for health, including hypertension. Clinical practice, however, is largely limited to awkward, inconvenient arm cuffs that provide only point-in-time measurement. High- throughput screening as well as personal health monitoring would benefit from a simple BP monitor that obtains accurate measurements with no training-ideally in seconds rather than minutes-and includes electronic health record (EHR) integration to minimize patient reporting error and noncompliance. The overall objective of this project is to use ultrasound, and in particular, Acoustic Radiation Force Impulse (ARFI) techniques, to develop an easy-to-use, cuffless, noninvasive, ultrasonic BP monitor, consisting of a compact sensor pad and readout. Placement of the pad in contact with the skin over an artery will immediately provide self-calibrated, accurate BP. The operating principle is analogous to a conventional arm cuff, which relies on acoustically observing arterial wall deflection in response to the differential between internal arterial pressure and an externally applied cuff pressure; however, this project will instead use ultrasound energy to impose highly localized but safe ARFI pressure pulses on an arterial wall and measure the microscopic deflection that results from the pressure differential. Furthermore, the high speed of ultrasound will allow blood pressure to be conveniently assessed in just a few seconds. The first Aim will demonstrate the ultrasonic pressure measurement method, on a commercial ultrasound testbed, by: developing algorithms to noninvasively track the pulsatile waveform using measured displacements in response to ARFI pulses; calibrating the pressure strength of the ARFI pulses; and reporting the absolute systolic and diastolic equivalent pressures for fluid- and blood-filled arterial phantoms, finishing with human clinical evaluation o the method according to the IEEE 1708-2014 Standard for cuffless blood pressure devices. The second Aim will seek to replace the piezoelectric testbed transducer with a low-cost capacitive micromachined ultrasonic transducer (which is well-suited to affordable personal health monitoring applications), likewise ending with clinical evaluation according to the IEEE standard. The final Aim will translate the testbed into a prototype instrument with a specifically-designed readout unit, incorporate an EHR interface, and culminate with a clinical study to evaluate the complete health monitor system in a low-resource context. This project is particularly relevant to the Department of Health & Human Services' "Million Hearts' Initiative", potentially touching a number of facets in the Million Hearts Logic Model by: improving measurement and reporting for large-scale epidemiological studies; increasing management effectiveness for ongoing hypertension medication; reducing hassle and barriers to use; and supporting further ambulatory research, both in the US and India.