NSF/FDA SiR: A Nonclinical Testing Tool for Wearable Photoplethysmography-Based Blood Pressure Monitoring Devices

NSF/FDA SiR：用于基于光电体积描记法的可穿戴血压监测设备的非临床测试工具

• 批准号: 2325722
• 负责人: Jin-Oh Hahn
• 金额: $ 20万
• 依托单位: University of Maryland, College Park
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-11-01 至 2025-10-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2325722&HistoricalAwards=false
• 关键词: NSF; FDA; SiR; Nonclinical; Testing; NSF; FDA; SiR; Nonclinical; Testing

This project intends to develop and implement a testing platform that can evaluate the accuracy of wearable blood pressure measurement devices. There is a recent surge in the development of wearable-based blood pressure monitoring technologies, and some are commercially available in the market. However, challenges remain in validating these devices to ensure the accuracy in BP measurement due to the limitations in acceptable testing procedures. Current evaluation is mostly based on resource-intensive clinical testing. Hence, successful completion of this project will enable low-cost and meaningful evaluation of wearable blood pressure monitoring devices by advancing our knowledge related to (i) the bio-signal measured by the wearable devices versus human physiology and tissue bio-mechanics; (ii) time-/cost-efficient bench testing of wearable blood pressure monitoring devices; (iii) the design and implementation of a platform that can imitate pulsatile blood flow in the human body under a wide range of physiological conditions. In addition, this project will foster the development of new blood pressure monitoring devices, stimulate medical device market with new technologies, improve the quality of life of humans with more accurate blood pressure measurement, and (iv) creating the next-generation of scientists with the knowledge of how to develop and evaluate novel medical and healthcare devices.Despite the recent surge in the development and deployment of photoplethysmography (PPG)-based wearable blood pressure monitoring devices, there is no bench test method that can objectively evaluate these high-impact healthcare devices. To bridge the gap, this project will develop a novel flow phantom circuit technology as a non-clinical testing platform capable of performing bench testing of PPG-based BP monitoring devices. The flow phantom technology provides a low-cost, low-risk, and highly effective evaluation environment by simulating a mock circulation flow loop and a tissue-mimicking pulsatile phantom. When a PPG-based blood pressure monitoring device is physically placed into the circuit, it operates in a dynamically changing environment with the flow phantom circuit. Hence, the platform can identify the impact of alterations in the sensor and algorithm elements in the device on blood pressure measurements. The platform can also evaluate the sensitivity of PPG-based blood pressure measurement algorithms to various flow and motion conditions. Last but not least, a mature version of this platform has the potential to transform the design and testing processes of a wide variety of PPG-based hemodynamic monitoring devices beyond blood pressure monitors. To achieve the project goal, the following tasks will be accomplished: (i) a bench flow phantom with physiologically relevant and controllable blood pressure, blood flow, anatomical, and optical characteristics will be constructed; and (ii) test methods using the flow phantom to evaluate the sensitivity of PPG-based blood pressure measurement algorithms to various flow and motion conditions will be developed. The result of this project will eventually lead us to a Regulatory Science Tool that will augment clinical studies and potentially reduce the burdensome approach of repeating full clinical validation protocols for alternative sensor-algorithm combinations, enabling more targeted clinical testing.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该项目旨在开发和实施一个测试平台，该平台可以评估可穿戴血压测量设备的准确性。 最近，基于可穿戴的血压监测技术的发展激增，有些在市场上可用。 但是，由于可接受的测试程序的限制，验证这些设备的验证仍在验证这些设备以确保BP测量的准确性。 当前的评估主要基于资源密集型临床测试。 因此，该项目的成功完成将通过促进与（i）通过可穿戴设备与人类生理学和组织生物力学相关的生物信号相关的知识来促进我们的知识来实现​​低成本和有意义的评估； （ii）可穿戴血压监测装置的时间/成本效益测试； （iii）在广泛的生理条件下，可以模仿人体脉动血流的平台的设计和实施。 此外，该项目将促进新的血压监测设备的开发，通过新技术刺激医疗设备市场，通过更准确的血压测量来改善人类的生活质量，以及（iv）创建下一代科学家，并了解如何开发和评估新颖的医疗和医疗设备的新型医疗和医疗服务的速度（ddepite）。设备，没有基准测试方法可以客观地评估这些高影响力的医疗设备。 为了弥合差距，该项目将开发出一种新型的流动幻影电路技术，作为一个非临床测试平台，能够对基于PPG的BP监视设备进行基准测试。 流动幻影技术通过模拟模拟循环循环和模拟组织模仿脉冲幻影，提供了低成本，低风险和高效的评估环境。 当将基于PPG的血压监测装置物理放入电路中时，它将在流动幻影电路的动态变化环境中运行。 因此，该平台可以确定设备中传感器和算法元素对血压测量的影响。 该平台还可以评估基于PPG的血压测量算法对各种流动和运动条件的敏感性。 最后但并非最不重要的一点是，该平台的成熟版本有可能改变血压监测器以外的各种基于PPG的血液动力学监测设备的设计和测试过程。 为了实现项目目标，将完成以下任务：（i）将构建具有生理相关和可控制的血压，血流，解剖和光学特征的基准流幻影； （ii）使用流量幻象来评估基于PPG的血压测量算法对各种流动和运动条件的敏感性的测试方法。 该项目的结果最终将导致我们采用一个监管科学工具，该工具将增强临床研究，并有可能减少重复替代传感器 - 叠加词组合组合的完整临床验证方案的繁重方法，从而实现了更具针对性的临床测试，这使NSF的法定任务反映了通过评估的构成范围和公众的支持者，这一奖项反映了构成的构成和基础。