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CN115969343A - A dynamic traceability device for an oscillometric electronic sphygmomanometer - Google Patents

A dynamic traceability device for an oscillometric electronic sphygmomanometer
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CN115969343A
CN115969343ACN202211606165.4ACN202211606165ACN115969343ACN 115969343 ACN115969343 ACN 115969343ACN 202211606165 ACN202211606165 ACN 202211606165ACN 115969343 ACN115969343 ACN 115969343A
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blood
simulated
artery
electronic sphygmomanometer
aorta
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张忠立
王灿
林正皓
刘春光
刘贝贝
冯齐斌
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Shanghai Institute of Measurement and Testing Technology
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Shanghai Institute of Measurement and Testing Technology
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Abstract

The invention relates to a dynamic tracing device of an oscillometric electronic sphygmomanometer, which comprises a blood liquid simulating groove and a bionic simulation device; the bionic simulation device comprises a blood supply pump, a constant-temperature blood simulating box, a simulated heart, a stepping motor, a simulated aorta and a simulated ulnar artery; the suction end of the blood supply pump extends into the blood-imitating liquid tank, and the output end of the blood supply pump is connected with the constant-temperature blood-imitating tank; the constant-temperature blood simulating box is connected with the simulated heart; the simulated heart is a piston cavity, the open end of the piston cavity is connected with a stepping motor, the stepping motor can control the process of the piston in a stepping mode, the closed end of the piston cavity is connected with the simulated aorta, and the simulated aorta is connected with the simulated ulnar radial artery; the front end of the simulated ulnar radial artery is provided with a first flow regulating valve and extends to the simulated blood liquid groove; dynamic pressure sensors are arranged in the simulated aorta and the simulated ulnar radial artery.

Description

Translated fromChinese
一种示波法电子血压计动态溯源装置A dynamic traceability device for oscillometric electronic sphygmomanometer

技术领域technical field

本发明涉及一种示波法电子血压计动态溯源装置,属于计量器材校准技术领域。The invention relates to a dynamic traceability device of an oscillometric electronic sphygmomanometer, which belongs to the technical field of calibration of measuring equipment.

背景技术Background technique

示波法电子血压计操作简便,不受人为因素的影响,重复性相对较好,已经被越来越广泛地应用。然而,目前针对示波法电子血压计动态检测能力校验却存在瓶颈多年。目前计量技术机构多采用无创血压模拟器来检测电子血压计的准确性,但是模拟器内部设置的包络线也是基于统计学的经验数值,只能实现对电子血压计的重复性测量,而无法实现血压动态测量准确性的量值溯源。The oscillometric electronic sphygmomanometer is easy to operate, is not affected by human factors, has relatively good repeatability, and has been more and more widely used. However, there are many years of bottlenecks in the verification of the dynamic detection capabilities of oscillometric electronic sphygmomanometers. At present, measurement technology institutions mostly use non-invasive blood pressure simulators to test the accuracy of electronic sphygmomanometers, but the envelope set inside the simulator is also based on statistical empirical values, which can only achieve repeatable measurement of electronic sphygmomanometers, but cannot Realize the value traceability of the accuracy of blood pressure dynamic measurement.

发明内容Contents of the invention

本发明的目的是根据示波法电子血压计动态检测的实际状况,基于真实人体动脉、骨骼、血液等仿生参数,提供一种示波法电子血压计动态溯源装置,其包括肱动脉、尺动脉与、桡动脉等上肢动脉血管系统的仿生手臂模型,且具备升主动脉与颈动脉分支功能,更接近真实血压系统,并采用生理盐水和甘油混合液调配的仿生血液,通过步进电机控制模拟心脏的心动周期和每搏出量,利用恒温装置实现仿生血液的温度接近人体体温,利用血管流量调节阀模拟血管外周阻力,并在袖带检测位置的血管内植入微型动态压力传感器读取内部仿生血液的收缩压和舒张压,实现对示波法电子血压计的准确度动态测量。The purpose of the present invention is to provide a dynamic traceability device for an oscillometric electronic sphygmomanometer based on the actual conditions of the dynamic detection of the oscillometric electronic sphygmomanometer, based on the bionic parameters such as real human arteries, bones, and blood, which includes brachial artery and ulnar artery. The bionic arm model of the upper extremity arteries and vascular systems, including the ascending aorta and the carotid artery, is closer to the real blood pressure system, and uses bionic blood prepared from a mixture of normal saline and glycerin, controlled by a stepping motor The cardiac cycle and stroke volume of the heart, using a constant temperature device to achieve the temperature of the bionic blood close to the body temperature, using the blood vessel flow regulating valve to simulate the peripheral resistance of the blood vessel, and implanting a miniature dynamic pressure sensor in the blood vessel at the detection position of the cuff to read the internal The systolic pressure and diastolic pressure of bionic blood realize the dynamic measurement of the accuracy of the oscillometric electronic sphygmomanometer.

本发明采取以下技术方案:The present invention takes the following technical solutions:

一种示波法电子血压计动态溯源装置,包括仿血液液体槽1、仿生模拟装置;所述仿生模拟装置包括供血泵11、恒温仿血液箱9、模拟心脏10、步进电机12、仿主动脉8、仿尺桡动脉4;所述供血泵11的吸入端伸入所述仿血液液体槽1中,输出端与恒温仿血液箱9连接;恒温仿血液箱9与模拟心脏10连接;所述模拟心脏10为一活塞腔体,活塞腔体的开口端与所述步进电机12连接,所述步进电机12可步进式控制活塞的进程,活塞腔体的闭口端与所述仿主动脉8连接,所述仿主动脉8与仿尺桡动脉4连接;所述仿尺桡动脉4前端设有第一流量调节阀2,并延伸至仿血液液体槽1;所述仿主动脉8与仿尺桡动脉4内均内置动态压力传感器5。A dynamic traceability device for an oscillometric electronic sphygmomanometer, comprising an imitation blood liquid tank 1 and a bionic simulation device;Artery 8, imitation ulnar radial artery 4; the suction end of theblood supply pump 11 extends into the imitation blood liquid tank 1, and the output end is connected with the constant temperature imitation blood tank 9; the constant temperature imitation blood tank 9 is connected with the simulatedheart 10; The simulatedheart 10 is a piston cavity, the open end of the piston cavity is connected with thestepping motor 12, and the steppingmotor 12 can control the progress of the piston step by step, and the closed end of the piston cavity is connected with the simulatedstepping motor 12. Theaorta 8 is connected, and theimitation aorta 8 is connected with the imitation ulnar radial artery 4; the front end of the imitation ulnar radial artery 4 is provided with a first flow regulating valve 2, and extends to the imitation blood liquid tank 1; theimitation aorta 8 and the imitation ulnar radial artery 4 are all built-in dynamic pressure sensors 5 .

优选的,还包括模拟手臂骨架3,其具有一铰接部,所述仿主动脉8与仿尺桡动脉4的衔接部位与所述铰接部对应。Preferably, it also includes a simulated arm skeleton 3, which has a hinge, and the joint of the simulatedaorta 8 and the simulated ulnar radial artery 4 corresponds to the hinge.

优选的,所述仿主动脉8包括仿制的分支动脉:升主动脉、主动脉弓、头臂动脉、颈动脉、右侧锁骨下动脉、肱动脉;各分支动脉都设有对应的防止血液回流的单向阀。Preferably, the simulatedaorta 8 includes simulated branch arteries: ascending aorta, aortic arch, brachiocephalic artery, carotid artery, right subclavian artery, and brachial artery; to the valve.

进一步的,所述模拟手臂骨架3采用金属材料,其总体质量和刚度与正常人体手臂的接近。Further, the simulated arm skeleton 3 is made of metal material, and its overall mass and rigidity are close to those of a normal human arm.

更进一步的,模拟手臂骨架3的下臂处于水平状态,上臂和下臂之间有20~30°的角度;上下臂之间处于铰接,能调节两者的角度。Furthermore, the lower arm of the simulated arm skeleton 3 is in a horizontal state, and there is an angle of 20-30° between the upper arm and the lower arm; the upper and lower arms are hinged, and the angle of both can be adjusted.

优选的,步进电机12由计算机控制,预先设置活塞最大行程和推动的频率。Preferably, thestepping motor 12 is controlled by a computer, and the maximum stroke of the piston and the frequency of pushing are preset.

进一步的,仿生血液由生理盐水和甘油调配,仿血液液体槽1的液体由供血泵11送达至顶部的恒温仿血液箱9,恒温仿血液箱9将液体保持在36.5±1°的温度范围内,当活塞下行时,血液通过安装有单向阀的通道进入模拟心脏10,当活塞上行时,并迸入升主动脉,部分血液进入主动脉弓和颈主动脉,并通过第二流量调节阀,最终流回恒温仿血液箱9;大部分的血液进入肱动脉,在肘关节处分流至尺动脉和桡动脉,并通过尺动脉和桡动脉的第一流量调节阀2,最终流回仿血液液体槽1。Further, the bionic blood is prepared by physiological saline and glycerin, and the liquid in the blood-supply liquid tank 1 is delivered to the constant-temperature simulated blood tank 9 on the top by theblood supply pump 11, and the constant-temperature simulated blood tank 9 keeps the liquid in a temperature range of 36.5±1° Inside, when the piston goes down, the blood enters the simulatedheart 10 through the channel equipped with a one-way valve; when the piston goes up, it bursts into the ascending aorta, and part of the blood enters the aortic arch and carotid aorta, and passes through the second flow regulating valve, Finally, it flows back to the constant temperature imitation blood box 9; most of the blood enters the brachial artery, shunts to the ulnar artery and the radial artery at the elbow joint, and passes through the first flow regulating valve 2 of the ulnar artery and the radial artery, and finally flows back to the imitation blood liquid Slot 1.

优选的,采用生理盐水和甘油调配而成的仿生血液。Preferably, bionic blood formulated with physiological saline and glycerin is used.

进一步的,肱动脉收缩压和舒张压的实际数值由植入的动态压力传感器读取,通过系统稳定后的数个周期内的收缩压和舒张压的平均值作为标准值,和待校验血压计检测的数次结果的平均值之间做误差对比。Further, the actual values of the systolic and diastolic blood pressure of the brachial artery are read by the implanted dynamic pressure sensor, and the average value of the systolic and diastolic pressure in several cycles after the system stabilizes is used as the standard value, and the blood pressure to be verified The error comparison is made between the average values of several test results.

本发明的有益效果在于:The beneficial effects of the present invention are:

1)建立较为完善的上肢动脉血管系统,其长度、直径、弹性模量、厚度等参数均可以实现接近人体生理参数,采用仿生动脉,用生理盐水和甘油调配仿生血液,与真实血液密度等物理参数接近,研制的装置总体呈现出接近正常人体生理系统的特征,更好地满足血压计检测真实人体肱动脉血压的工况;1) Establish a relatively complete upper limb arterial vascular system, whose length, diameter, elastic modulus, thickness and other parameters can be close to the physiological parameters of the human body, using bionic arteries, using physiological saline and glycerin to prepare bionic blood, and real blood density and other physical parameters The parameters are close, and the developed device generally presents the characteristics close to the normal human physiological system, which better meets the working conditions of the real human brachial artery blood pressure detected by the sphygmomanometer;

2)是肱动脉收缩压和舒张压的实际数值由植入的动态压力传感器读取,通过系统稳定后的数个周期内的收缩压和舒张压的平均值作为标准值,和血压计检测的数次结果的平均值之间做误差对比,既符合血压计检测真实人体,通过血压计数值评判人体肱动脉内部血压的测量方式,又能直接获取袖带检测处的肱动脉实际血压值,实现血压计的直接动态溯源;2) The actual values of the systolic and diastolic blood pressure of the brachial artery are read by the implanted dynamic pressure sensor, and the average value of the systolic and diastolic pressure in several cycles after the system stabilizes is used as the standard value, and the value detected by the sphygmomanometer The error comparison between the average value of several results is not only in line with the detection of real human body by sphygmomanometer, but also the measurement method of judging the internal blood pressure of human brachial artery through the sphygmomanometer value, and can directly obtain the actual blood pressure value of brachial artery at the detection point of the cuff, so as to realize Direct dynamic traceability of sphygmomanometer;

3)创新研发的流量调节阀和模拟心脏模型,通过调节流量调节阀的数值,可以改变动脉系统的外周阻力,通过调节血液粘度、心脏搏出量和心脏搏动频率等参数,可以实现对高血脂、心跳快慢等单一变量的控制与模拟,解决医学临床试验无法完成的单一因素影响的实验研究,可以开展血管孔径、血管硬度、血液粘稠度、血液密度、心跳频率、心脏搏出量、血管外周阻力等因素对人体血压的单一影响程度与趋势,为精准医疗提供可靠的研究基础保障,具有较高的医学研究价值。3) The innovatively developed flow regulating valve and simulated heart model can change the peripheral resistance of the arterial system by adjusting the value of the flow regulating valve, and can realize the treatment of hyperlipidemia by adjusting parameters such as blood viscosity, cardiac output and cardiac beat frequency. , heartbeat speed and other single variable control and simulation, to solve the experimental research of the influence of a single factor that cannot be completed in medical clinical trials, and can carry out vascular aperture, vascular hardness, blood viscosity, blood density, heartbeat frequency, cardiac output, vascular The single effect degree and trend of peripheral resistance and other factors on human blood pressure provide a reliable research basis for precision medicine and have high medical research value.

4)此外,通过本装置对人体血压的模拟以及对电子血压计的动态溯源,可以为电子血压计在人体无创测血压的进一步改进提供丰富的实验数据。4) In addition, through the simulation of human blood pressure and the dynamic traceability of the electronic sphygmomanometer by this device, abundant experimental data can be provided for the further improvement of the electronic sphygmomanometer in the non-invasive blood pressure measurement of the human body.

附图说明Description of drawings

图1是本发明示波法电子血压计动态溯源装置的结构示意图。Fig. 1 is a schematic structural diagram of a dynamic traceability device for an oscillometric electronic sphygmomanometer according to the present invention.

图2是本发明示波法电子血压计动态溯源装置的结构在另一视角下的效果图。Fig. 2 is an effect diagram of the structure of the dynamic traceability device of the oscillometric electronic sphygmomanometer in another perspective according to the present invention.

图3是与图2相对应的效果示意图。FIG. 3 is a schematic diagram of the effect corresponding to FIG. 2 .

图中,1.仿血液液体槽,2.第一流量调节阀,3.模拟手臂骨架,4.尺动脉、桡动脉(带单向阀),5.动态压力传感器,6.肱动脉(带单向阀),7.升主动脉(带单向阀),8.主动脉弓、头臂动脉、颈动脉(均带单向阀),9.温仿血液箱,10.模拟心脏,11.供血泵,12.袖带,13.被测血压计。In the figure, 1. imitation blood liquid tank, 2. first flow regulating valve, 3. simulated arm skeleton, 4. ulnar artery, radial artery (with one-way valve), 5. dynamic pressure sensor, 6. brachial artery (with One-way valve), 7. Ascending aorta (with one-way valve), 8. Aortic arch, brachiocephalic artery, carotid artery (all with one-way valve), 9. Warm imitation blood box, 10. Simulated heart, 11. Blood supply Pump, 12. cuff, 13. measured blood pressure monitor.

具体实施方式Detailed ways

下面结合附图和具体实施例对本发明进一步说明。The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments.

图1和2为本发明示波法血压计动态溯源装置位于两个不同视角下的原理示意图。图3是与图2对应的渲染图,与图2结合起来看可以更清晰的展示本装置的结构。根据上肢血管系统的情况,采用较完备的上肢动脉系统的主要血管,包括升主动脉、主动脉弓、头臂动脉、颈动脉、右侧锁骨下动脉、肱动脉、尺动脉、桡动脉等。所有动脉分支都设有单向阀,防止血液回流。1 and 2 are principle schematic diagrams of the dynamic traceability device of the oscillometric sphygmomanometer of the present invention located at two different viewing angles. Fig. 3 is a rendering corresponding to Fig. 2, which can show the structure of the device more clearly when combined with Fig. 2 . According to the condition of upper extremity vascular system, relatively complete main vessels of upper extremity arterial system were used, including ascending aorta, aortic arch, brachiocephalic artery, carotid artery, right subclavian artery, brachial artery, ulnar artery, radial artery, etc. All arterial branches are equipped with one-way valves to prevent backflow of blood.

图1中标号3为模拟手臂的上下臂骨架,采用相应金属材料,既保障足够的强度用以确保模拟手臂及其肌肉组织和血管的位置稳定性,又使其总体质量和刚度与正常人体手臂的参数接近。The number 3 in Figure 1 is the skeleton of the upper and lower arms of the simulated arm, which adopts corresponding metal materials to ensure sufficient strength to ensure the positional stability of the simulated arm and its muscle tissue and blood vessels, and to make its overall quality and stiffness comparable to that of a normal human arm parameters are close.

模拟手臂的下臂处于水平状态,上臂和下臂之间有约(20~30)°的角度,这样是为了保持和血压计测量状态一致,上下臂之间处于铰接,能调节两者的角度。保留主动脉弓和颈动脉两条分支,是为了实现血液的分流,避免当袖带完全阻隔肱动脉时,造成肱动脉处血压的陡增。这样的设计更符合人体生理情形和真实的血压计测量情况。The lower arm of the simulated arm is in a horizontal state, and there is an angle of about (20-30)° between the upper arm and the lower arm. This is to maintain the same measurement status as the sphygmomanometer. The upper and lower arms are hinged, and the angle of the two can be adjusted. . The two branches of the aortic arch and the carotid artery are preserved to realize the shunt of blood and avoid a sudden increase in blood pressure at the brachial artery when the cuff completely blocks the brachial artery. Such a design is more in line with the physiological situation of the human body and the real measurement situation of the sphygmomanometer.

如图1-2所示,模拟心脏10为一活塞腔体,由底部的步进电机12控制。其中,步进电机12由计算机控制,可以预先设置活塞最大行程和推动的频率。仿生血液由生理盐水和甘油调配,仿生血液槽1的血液由供血泵11送达至顶部的恒温仿血液箱9,恒温仿血液箱9将仿生血液保持在(36.5±1)°的温度范围内(正常人血液温度约36.5°),当活塞下行时,血液通过安装有单向阀的通道进入模拟心脏10,并迸入升主动脉,部分血液进入主动脉弓和颈主动脉,并通过的第二流量调节阀13,最终流回恒温箱。大部分的血液进入肱动脉,在肘关节处分流至尺动脉和桡动脉,并通过尺动脉和桡动脉的第一流量调节阀2,最终流回仿生血液槽1。As shown in Figures 1-2, the simulatedheart 10 is a piston chamber controlled by a steppingmotor 12 at the bottom. Wherein, thestepper motor 12 is controlled by a computer, and the maximum stroke of the piston and the frequency of pushing can be preset. The bionic blood is formulated with physiological saline and glycerin, and the blood in the bionic blood tank 1 is delivered to the constant temperature simulated blood tank 9 on the top by theblood supply pump 11, and the constant temperature simulated blood tank 9 keeps the bionic blood within the temperature range of (36.5±1)° (Normal human blood temperature is about 36.5°), when the piston descends, the blood enters the simulatedheart 10 through the channel equipped with a one-way valve, and bursts into the ascending aorta, and part of the blood enters the aortic arch and carotid aorta, and passes through the second Theflow regulating valve 13 finally flows back to the thermostat. Most of the blood enters the brachial artery, is shunted to the ulnar artery and the radial artery at the elbow joint, passes through the first flow regulating valve 2 of the ulnar artery and the radial artery, and finally flows back to the bionic blood tank 1 .

本发明的示波法电子血压计动态溯源装置具有三大主要创新点:The dynamic traceability device of the oscillometric electronic sphygmomanometer of the present invention has three major innovations:

一是建立较为完善的上肢动脉血管系统,其长度、直径、弹性模量、厚度等参数均接近人体生理参数,采用仿生肌肉组织和仿生皮肤,而且用生理盐水和甘油调配仿生血液,与真实血液密度等物理参数接近,装置总体呈现出接近正常人体生理系统的特征,更好地满足血压计检测真实人体肱动脉血压的工况;The first is to establish a relatively complete upper limb arterial vascular system, whose length, diameter, elastic modulus, thickness and other parameters are close to the physiological parameters of the human body, using bionic muscle tissue and bionic skin, and using physiological saline and glycerin to prepare bionic blood, which is similar to real blood The physical parameters such as density are close, and the device generally presents the characteristics close to the normal human physiological system, which better meets the working conditions of the sphygmomanometer to detect the real human brachial artery blood pressure;

二是肱动脉收缩压和舒张压的实际数值由植入的动态压力传感器读取,通过系统稳定后的数个周期内的收缩压和舒张压的平均值作为标准值,和血压计检测的数次结果的平均值之间做误差对比,既符合血压计检测真实人体,通过血压计数值评判人体肱动脉内部血压的测量方式,又能直接获取袖带检测处的肱动脉实际血压值,实现血压计的直接动态溯源;Second, the actual values of systolic and diastolic blood pressure of the brachial artery are read by the implanted dynamic pressure sensor, and the average value of the systolic and diastolic blood pressure in several cycles after the system stabilizes is used as the standard value, and the data detected by the sphygmomanometer The error comparison between the average values of the two results is not only in line with the measurement method of the real human body detected by the sphygmomanometer, but also the measurement method of the internal blood pressure of the brachial artery of the human body can be judged by the sphygmomanometer value, and the actual blood pressure value of the brachial artery at the detection point of the cuff can be directly obtained to realize blood pressure. direct dynamic traceability of the meter;

三是第一、第二流量调节阀2、13和模拟心脏10的模型,通过调节阀门的数值,可以改变动脉系统的外周阻力,通过调节血液粘度、心脏搏出量和心脏搏动频率等参数,可以实现对高血脂、心跳快慢等单一变量的控制与模拟,解决医学临床试验无法完成的单一因素影响的实验研究,可以开展血管孔径、血管硬度、血液粘稠度、血液密度、心跳频率、心脏搏出量、血管外周阻力等因素对人体血压的单一影响程度与趋势,为精准医疗提供可靠的研究基础保障,具有较高的医学研究价值。此外,通过本装置对人体血压的模拟以及对电子血压计的动态溯源,可以为电子血压计在人体无创测血压的进一步改进提供丰富的实验数据,为研发新型高精尖医疗诊断设备做强有力的技术支撑。The third is the first and secondflow regulating valves 2, 13 and the model of thesimulated heart 10. By adjusting the value of the valves, the peripheral resistance of the arterial system can be changed. By adjusting parameters such as blood viscosity, cardiac output and cardiac beat frequency, It can realize the control and simulation of single variables such as hyperlipidemia and heartbeat speed, and solve the experimental research on the influence of single factors that cannot be completed in medical clinical trials. It can carry out vascular aperture, blood vessel hardness, blood viscosity, blood density, heartbeat frequency, The individual influence degree and trend of stroke volume, vascular peripheral resistance and other factors on human blood pressure provide a reliable research basis for precision medicine and have high medical research value. In addition, through the simulation of human blood pressure and the dynamic traceability of electronic sphygmomanometers, rich experimental data can be provided for the further improvement of electronic sphygmomanometers in non-invasive blood pressure measurement on the human body, and it will be a powerful force for the development of new high-precision medical diagnostic equipment. technical support.

以上是本发明的优选实施例,本领域普通技术人员还可以在此基础上进行各种变换或改进,在不脱离本发明总的构思的前提下,这些变换或改进都应当属于本发明要求保护的范围之内。The above are the preferred embodiments of the present invention. Those skilled in the art can also make various transformations or improvements on this basis. Under the premise of not departing from the general concept of the present invention, these transformations or improvements should all belong to the claims of the present invention. within the range.

Claims (9)

7. The oscillometric electronic sphygmomanometer as claimed in claim 3, wherein the tracing device comprises: the bionic blood is prepared by normal saline and glycerol, the liquid in the blood-imitating liquid tank (1) is delivered to a constant-temperature blood-imitating tank (9) at the top by a blood-supply pump (11), the constant-temperature blood-imitating tank (9) keeps the liquid within the temperature range of (36.5 +/-1) °, when the piston descends, the blood enters the simulated heart (10) through a channel provided with a one-way valve, when the piston ascends, the blood spurts into the ascending aorta, part of the blood enters the aortic arch and the carotid aorta and passes through a second flow regulating valve (13), and finally flows back to the constant-temperature blood-imitating tank (9); most of the blood enters the brachial artery, shunts to the ulnar artery and the radial artery at the elbow joint, passes through the first flow regulating valves (2) of the ulnar artery and the radial artery and finally flows back to the blood-imitating liquid tank (1).
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