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

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现一个测试平台，可以评估可穿戴血压测量设备的准确性。 最近，可穿戴式血压监测技术的发展迅猛，有些技术已在市场上投入使用。 然而，由于可接受的测试程序的限制，在验证这些设备以确保血压测量的准确性方面仍然存在挑战。 目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推进我们以下方面的知识，对可穿戴血压监测设备进行低成本且有意义的评估：（i）可穿戴设备测量的生物信号与人体生理学和组织生物力学的比较； (ii) 可穿戴血压监测设备的时间/成本高效的台架测试； （iii）设计和实现一个可以在多种生理条件下模拟人体脉动血流的平台。 此外，该项目将促进新型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改善人类的生活质量，以及（iv）培养下一代科学家如何开发和评估新型医疗和保健设备的知识。尽管最近基于光电体积描记法 (PPG) 的可穿戴血压监测设备的开发和部署激增，但还没有可以客观评估这些高影响力的台架测试方法医疗保健设备。 为了弥补这一差距，该项目将开发一种新型流动幻象电路技术作为非临床测试平台，能够对基于 PPG 的血压监测设备进行台架测试。 流动体模技术通过模拟模拟循环流动回路和模仿组织的脉动体模，提供了低成本、低风险和高效的评估环境。 当基于 PPG 的血压监测设备物理放置到电路中时，它会在流动模型电路的动态变化环境中运行。 因此，该平台可以识别设备中传感器和算法元件的变化对血压测量的影响。 该平台还可以评估基于 PPG 的血压测量算法对各种流量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仪以外的各种基于 PPG 的血液动力学监测设备的设计和测试流程。 为了实现该项目目标，将完成以下任务：（i）构建具有生理相关且可控的血压、血流、解剖和光学特性的台式流动模型； (ii) 将开发使用流动模型来评估基于 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引导我们开发出一种监管科学工具，该工具将增强临床研究，并有可能减少对替代传感器算法组合重复完整临床验证方案的繁琐方法，从而实现更有针对性的临床测试。该奖项反映了 NSF 的法定使命通过使用基金会的智力优点和更广泛的影响审查标准进行评估，并被认为值得支持。