Guo Cheng-Yan, Perng Jau-Woei, Chen Li-Ching, Hsieh Tung-Li
Accurate Meditech Inc., New Taipei City 241406, Taiwan.
Department of Mechanical and Electromechanical Engineering, National Sun Yat-sen University, 70 Lienhai Road, Kaohsiung 80424, Taiwan.
Micromachines (Basel). 2023 Jun 9;14(6):1218. doi: 10.3390/mi14061218.
Devices for cuffless blood pressure (BP) measurement have become increasingly widespread in recent years. Non-invasive continuous BP monitor (BPM) devices can diagnose potential hypertensive patients at an early stage; however, these cuffless BPMs require more reliable pulse wave simulation equipment and verification methods. Therefore, we propose a device to simulate human pulse wave signals that can test the accuracy of cuffless BPM devices using pulse wave velocity (PWV).
We design and develop a simulator capable of simulating human pulse waves comprising an electromechanical system to simulate the circulatory system and an arm model-embedded arterial phantom. These parts form a pulse wave simulator with hemodynamic characteristics. We use a cuffless device for measuring local PWV as the device under test to measure the PWV of the pulse wave simulator. We then use a hemodynamic model to fit the cuffless BPM and pulse wave simulator results; this model can rapidly calibrate the cuffless BPM's hemodynamic measurement performance.
We first used multiple linear regression (MLR) to generate a cuffless BPM calibration model and then investigated differences between the measured PWV with and without MLR model calibration. The mean absolute error of the studied cuffless BPM without the MLR model is 0.77 m/s, which improves to 0.06 m/s when using the model for calibration. The measurement error of the cuffless BPM at BPs of 100-180 mmHg is 1.7-5.99 mmHg before calibration, which decreases to 0.14-0.48 mmHg after calibration.
This study proposes a design of a pulse wave simulator based on hemodynamic characteristics and provides a standard performance verification method for cuffless BPMs that requires only MLR modeling on the cuffless BPM and pulse wave simulator. The pulse wave simulator proposed in this study can be used to quantitively assess the performance of cuffless BPMs. The proposed pulse wave simulator is suitable for mass production for the verification of cuffless BPMs. As cuffless BPMs become increasingly widespread, this study can provide performance testing standards for cuffless devices.
近年来，无袖带血压测量设备越来越普及。无创连续血压监测（BPM）设备可在早期诊断潜在的高血压患者；然而，这些无袖带BPM需要更可靠的脉搏波模拟设备和验证方法。因此，我们提出一种模拟人体脉搏波信号的设备，该设备可使用脉搏波速度（PWV）来测试无袖带BPM设备的准确性。
我们设计并开发了一种能够模拟人体脉搏波的模拟器，该模拟器包括一个用于模拟循环系统的机电系统和一个嵌入手臂模型的动脉模型。这些部分构成了一个具有血流动力学特性的脉搏波模拟器。我们使用一种用于测量局部PWV的无袖带设备作为被测设备来测量脉搏波模拟器的PWV。然后，我们使用血流动力学模型来拟合无袖带BPM和脉搏波模拟器的结果；该模型可以快速校准无袖带BPM的血流动力学测量性能。
我们首先使用多元线性回归（MLR）生成无袖带BPM校准模型，然后研究有无MLR模型校准情况下测量的PWV之间的差异。所研究的无MLR模型的无袖带BPM的平均绝对误差为0.77 m/s，使用该模型校准时可提高到0.06 m/s。在校准前，无袖带BPM在100 - 180 mmHg血压下的测量误差为1.7 - 5.99 mmHg，校准后降至0.14 - 0.48 mmHg。
本研究提出了一种基于血流动力学特性的脉搏波模拟器设计，并为无袖带BPM提供了一种标准性能验证方法，该方法仅需在无袖带BPM和脉搏波模拟器上进行MLR建模。本研究中提出的脉搏波模拟器可用于定量评估无袖带BPM的性能。所提出的脉搏波模拟器适用于大规模生产以验证无袖带BPM。随着无袖带BPM越来越普及，本研究可为无袖带设备提供性能测试标准。
