CN104586407B - Multi-parameter physiological indication detection device and detection method thereof - Google Patents
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Abstract
一种多参数生理指征检测装置及其检测方法,属于医疗器械检测设备技术领域。该测量装置包括探头和主机,探头包括多参数集成信号采集部件、传热部件和散热部件;主机包括数据处理模块和平板电脑;其检测方法是将探头采集到环境温湿度、人体温湿度、脉搏和血流速度等参数信号输入到主机,由数据处理模块进行数据的分析计算,平板电脑控制数据处理模块采集信号的时序并实现人机交互,最终由平板电脑显示测试结果。本发明可以测量环境温湿度、体表温湿度、脉搏、血氧饱和度、血流速度、血红蛋白浓度等多项生理参数指标,实现了产品的高度集成。特别的,该装置通过上述参数可以无创测量人体血糖浓度。
A multi-parameter physiological indication detection device and a detection method thereof belong to the technical field of medical device detection equipment. The measuring device includes a probe and a host. The probe includes a multi-parameter integrated signal acquisition component, a heat transfer component, and a heat dissipation component; the host includes a data processing module and a tablet computer; Parameter signals such as blood flow velocity and other parameters are input to the host computer, and the data analysis and calculation are performed by the data processing module. The tablet computer controls the timing of the signal acquisition by the data processing module and realizes human-computer interaction, and finally the test result is displayed by the tablet computer. The invention can measure many physiological parameter indexes such as environment temperature and humidity, body surface temperature and humidity, pulse, blood oxygen saturation, blood flow velocity, hemoglobin concentration, etc., and realizes high integration of products. In particular, the device can non-invasively measure the blood glucose concentration of the human body through the above parameters.
Description
技术领域technical field
本发明涉及一种生理指征检测仪器,属于医疗器械检测设备技术领域。The invention relates to a physiological indication detection instrument, which belongs to the technical field of medical instrument detection equipment.
背景技术Background technique
在国家食品药品监督管理局查询相关的医疗器械注册产品,发现目前国内还没有无创测量血糖、血红蛋白、血流速度等多项参数的国内医疗器械和进口医疗器械,比较普遍的产品都只能检测一项或两项生理参数,如血糖仪(有创或微创)、血红蛋白计(有创或微创)、脉搏血氧仪(无创)等。有创和微创测量法虽然准确率高,但因为需要采取血液样本,存在一定的感染风险,同时也给患者带来了不少痛苦。因此研究一种无创的多参数医疗设备意义重大。Inquire about relevant medical device registration products in the State Food and Drug Administration, and found that there are no domestic or imported medical devices that non-invasively measure blood sugar, hemoglobin, blood flow velocity and other parameters in China, and the more common products can only be tested One or two physiological parameters, such as blood glucose meter (invasive or minimally invasive), hemoglobin meter (invasive or minimally invasive), pulse oximeter (noninvasive), etc. Although invasive and minimally invasive measurement methods have a high accuracy rate, there is a certain risk of infection because of the need to take blood samples, and they also bring a lot of pain to patients. Therefore, it is of great significance to study a non-invasive multi-parameter medical device.
无创检测血氧饱和度的设备已经有所应用,如专利文献CN1011O3921A(一种测量血氧饱和度的方法和装置)中的利用光谱分析法无创测量血氧饱和度。其理论基础是朗伯比尔法则。将两种发出不同光谱的光电二极管放置在被检测部位的同一侧在被测部位的另一侧放置光电接收装置,然后根据得到的两种光电流的交流分量比计算血氧饱和度。无创测量血红蛋白浓度现在还存在一些问题,如组织中成分的干扰,导致精度较低。Devices for non-invasive detection of blood oxygen saturation have been used, such as the non-invasive measurement of blood oxygen saturation using spectral analysis in the patent document CN1011O3921A (a method and device for measuring blood oxygen saturation). Its theoretical basis is Lambert-Beer's law. Two kinds of photodiodes emitting different spectra are placed on the same side of the detected part, and a photoelectric receiving device is placed on the other side of the measured part, and then the blood oxygen saturation is calculated according to the AC component ratio of the two photocurrents obtained. There are still some problems in the non-invasive measurement of hemoglobin concentration, such as the interference of components in tissues, resulting in low accuracy.
无创测量人体血糖浓度,目前还是一个挑战。有很多学者基于不同原理提出了很多方法,其中美国专利(US.Pat.NO.5975305;US.Pat.NO.20060094941)是最早实现一种基于代谢率热整合法的热-光学无创血糖检测方法。该方法假设体内的热量来源于代谢释放的能量,而代谢的主要能源物质是糖类,绝大多数组织细胞通过葡萄糖的有氧氧化过程产生和获得能量。由于在平衡状态下,(静态)产热量和散热量在数值上相等,那么通过测量血氧总量和散热量等生理参数就可以估计血糖值。Non-invasive measurement of human blood glucose concentration is still a challenge. Many scholars have proposed many methods based on different principles, among which the US patent (US.Pat.NO.5975305; US.Pat.NO.20060094941) is the first to realize a thermal-optical non-invasive blood glucose detection method based on the thermal integration of metabolic rate . This method assumes that the heat in the body comes from the energy released by metabolism, and the main energy source of metabolism is sugar, and most tissue cells generate and obtain energy through the aerobic oxidation process of glucose. Since the (static) heat production and heat dissipation are numerically equal in equilibrium, blood glucose levels can be estimated by measuring physiological parameters such as total blood oxygen and heat dissipation.
美国专利(US.Pat.NO.5795305和US.Pat.NO.5924996)以及日本株式会社日立制作所提出了一种通过检测皮肤温度来获取血糖的专利(专利号ZL 03178742.8),并需要经过血氧饱和度和血液流动体积进行校正得到稳定的测量数据。这种血糖水平测定设备的测量原理也是基于热代谢整合法,其组成包括:一、热量测量装置:用于测量多个体表温度和周围环境温度以获得用于与计算从体表耗散的热量有关的对流热传递的热量和辐射传递的热量的信息;二、氧体积测量装置:用于获得关于血氧体积的信息;三、光学测量装置:用于计算血红蛋白浓度和血红蛋白氧饱和度。U.S. Patents (US.Pat.NO.5795305 and US.Pat.NO.5924996) and Hitachi Manufacturing Co., Ltd. of Japan have proposed a patent (Patent No. ZL 03178742.8) to obtain blood sugar by detecting skin temperature, and need to go through blood Oxygen saturation and blood flow volume are corrected to obtain stable measurement data. The measurement principle of this blood glucose level determination equipment is also based on the thermal metabolism integration method, and its composition includes: 1. Calorie measurement device: used to measure multiple body surface temperatures and ambient temperature to obtain and calculate the heat dissipated from the body surface Information about heat transfer by convection heat transfer and heat transfer by radiation; 2. Oxygen volume measurement device: used to obtain information about blood oxygen volume; 3. Optical measurement device: used to calculate hemoglobin concentration and hemoglobin oxygen saturation.
上述专利技术存在以下问题:一是人机交互功能较弱,操作不便,而且不能长期存储检测数据,难以实现数据的定期矫正工作;二是一些参数检测精度不高,有待进一步提高参数检测的精度和灵敏度;三是测量的参数较为单一,没有有效整合各个测试参数。The above-mentioned patented technology has the following problems: First, the human-computer interaction function is weak, the operation is inconvenient, and the detection data cannot be stored for a long time, and it is difficult to realize the regular correction of the data; the second is that the detection accuracy of some parameters is not high, and the accuracy of parameter detection needs to be further improved and sensitivity; the third is that the measured parameters are relatively single, and there is no effective integration of various test parameters.
发明内容Contents of the invention
本发明的目的是提供一种多参数生理指征检测装置及测试方法,增强生理检测仪器的人机交互功能,提高参数测量精度,克服测试参数单一的缺陷。The purpose of the present invention is to provide a multi-parameter physiological indication detection device and testing method, enhance the human-computer interaction function of the physiological testing instrument, improve the parameter measurement accuracy, and overcome the defect of a single test parameter.
本发明的技术方案如下:Technical scheme of the present invention is as follows:
一种多参数生理指征检测装置,该装置包括探头和主机,探头与主机之间使用有线或无线通信;所述探头包括多参数集成信号采集部件、传热部件和散热部件;所述多参数集成信号采集部件包含用于检测体表和环境温度参数的红外辐射传感器、用于检测环境和体表湿度参数的湿度传感器、红外光发射阵列、红外光接收器、用于检测血流量参数的近端热敏电阻和远端热敏电阻;所述主机包含数据处理模块,所述数据处理模块包含微处理器、信号调理单元和存储单元;所述信号调理单元包含放大滤波电路、A/D转换电路和积分电路;多参数集成信号采集部件采集到的信号经信号调理单元处理后送入微处理器,由微处理器对信号进行计算处理,将计算结果送入存储单元存储;红外光发射阵列与微处理器的输出线路连接,其特征在于:所述主机还包括平板电脑,该平板电脑包括通信协议模块、生理参数检测模块、用户交互模块和触摸显示屏;平板电脑与数据处理模块通过串行接口连接,实现双向通信;生理参数检测模块将得到的结果传送给用户交互模块,并在触摸显示屏上显示,实现人机交互功能。A multi-parameter physiological indication detection device, the device includes a probe and a host, and wired or wireless communication is used between the probe and the host; the probe includes a multi-parameter integrated signal acquisition component, a heat transfer component and a heat dissipation component; the multi-parameter The integrated signal acquisition component includes an infrared radiation sensor for detecting body surface and ambient temperature parameters, a humidity sensor for detecting environment and body surface humidity parameters, an infrared light emitting array, an infrared light receiver, and a proximity sensor for detecting blood flow parameters. terminal thermistor and remote thermistor; the host computer includes a data processing module, and the data processing module includes a microprocessor, a signal conditioning unit and a storage unit; the signal conditioning unit includes an amplification filter circuit, an A/D conversion circuit and integral circuit; the signal collected by the multi-parameter integrated signal acquisition part is processed by the signal conditioning unit and then sent to the microprocessor, and the microprocessor calculates and processes the signal, and sends the calculation result to the storage unit for storage; the infrared light emitting array and The output line connection of the microprocessor is characterized in that: the host computer also includes a tablet computer, and the tablet computer includes a communication protocol module, a physiological parameter detection module, a user interaction module and a touch display screen; the tablet computer and the data processing module pass a serial The interface connection realizes two-way communication; the physiological parameter detection module transmits the obtained results to the user interaction module and displays them on the touch screen to realize the human-computer interaction function.
所述的多参数生理指征检测装置,其特征在于:所述平板电脑采用ARM架构的安卓操作系统的平板电脑。The multi-parameter physiological indication detection device is characterized in that: the tablet computer adopts an Android operating system tablet computer with an ARM architecture.
所述的多参数生理指征检测装置,其特征在于:所述散热部件采用散热片,所述散热片为梳齿平板结构。The multi-parameter physiological indication detection device is characterized in that: the heat dissipation component adopts a heat dissipation fin, and the heat dissipation fin is a comb-tooth plate structure.
所述的多参数生理指征检测装置,其特征在于:所述探头采用夹子式结构。The multi-parameter physiological indication detection device is characterized in that the probe adopts a clip-type structure.
所述的多参数生理指征检测装置,其特征在于:所述传热部件采用传热棒,所述传热棒采用十字架结构、钉子结构、哑铃结构、柱体或六面体结构。The multi-parameter physiological indication detection device is characterized in that: the heat transfer component adopts a heat transfer rod, and the heat transfer rod adopts a cross structure, a nail structure, a dumbbell structure, a cylinder or a hexahedron structure.
所述的多参数生理指征检测装置,其特征在于:所述传热棒顶端镀有金层。The multi-parameter physiological indication detection device is characterized in that: the top of the heat transfer rod is coated with a gold layer.
所述装置的一种多参数生理指征检测方法,其特征在于该方法包括如下步骤:A multi-parameter physiological indication detection method of the device, characterized in that the method comprises the following steps:
1)生理参数检测模块通过串行接口发送指令,控制微处理器进行信号的采集;1) The physiological parameter detection module sends instructions through the serial interface, and controls the microprocessor to collect signals;
2)在被测部位放入探头之前,通过远端热敏电阻和红外辐射传感器得到环境温度值T1,通过湿度传感器得到环境湿度H1; 2 ) Before putting the probe into the measured part, the ambient temperature value T1 is obtained through the remote thermistor and the infrared radiation sensor, and the ambient humidity H1 is obtained through the humidity sensor ;
3)被测部位放入探头之后,通过近端热敏电阻得到人体温度值T2,通过湿度传感器得到人体湿度H2;3) After the measured part is put into the probe, the temperature value T2 of the human body is obtained through the proximal thermistor, and the humidity H2 of the human body is obtained through the humidity sensor ;
4)测量人体血氧饱和度和脉搏:通过红外光发射阵列发射四个波长的红外光,波长分别为660nm、730nm、800nm和940nm,利用红外接收器接收透过被测部位后的光信号,利用公式(1)得到人体血氧饱和度:4) Measure the blood oxygen saturation and pulse of the human body: emit four wavelengths of infrared light through the infrared light emitting array, the wavelengths are 660nm, 730nm, 800nm and 940nm, and use the infrared receiver to receive the optical signal after passing through the measured part. Use the formula (1) to get the blood oxygen saturation of the human body:
SpO2=α2×R2+α1×R+α0 (1)SpO 2 =α 2 ×R 2 +α 1 ×R+α 0 (1)
其中,SpO2为人体血氧饱和度,α0=100.72,α1=10.28,α2=-26.67, 和分别为660nm和940nm波长出射光强随脉搏变化的最小值,和分别为660nm和940nm波长出射光强随脉搏变化的最大值;Among them, SpO 2 is the oxygen saturation of human blood, α 0 =100.72, α 1 =10.28, α 2 =-26.67, and They are the minimum value of the output light intensity of 660nm and 940nm wavelengths changing with the pulse, and They are the maximum value of the output light intensity at 660nm and 940nm wavelengths changing with the pulse;
根据出射光强的变化频率计算得到脉搏Pulse;According to the intensity of the emitted light Change the frequency to calculate the pulse Pulse;
5)测试血红蛋白浓度Hgb:血液成分中各浓度之间关系如公式(2)所示,5) Test the hemoglobin concentration Hgb: the relationship between the concentrations in the blood components is as shown in formula (2),
其中,C0为血液浓度,CHb为脱氧血红蛋白浓度,为氧结合血红蛋白浓度,为水浓度,Cother为剩余成分的浓度;Among them, C 0 is the blood concentration, CHb is the concentration of deoxygenated hemoglobin , is the oxygen-bound hemoglobin concentration, is the water concentration, C other is the concentration of the remaining components;
求解方程组(3),得到CHb和 Solving equations (3), get CHb and
其中,S为组织成分散射引起的衰减因子,由于剩余成分的浓度和散射引起的衰减相对较小,把看成常数,ε表示物质在特定波长下的吸光系数,I0表示入射光的光强,I表示透过被测部位后的光强,dpef是特定波长下的路径修正因子,血红蛋白浓度 in, S is the attenuation factor caused by the scattering of tissue components, because the concentration of the remaining components and the attenuation caused by scattering are relatively small, put As a constant, ε represents the absorption coefficient of the substance at a specific wavelength, I 0 represents the light intensity of the incident light, I represents the light intensity after passing through the measured part, d pef is the path correction factor at a specific wavelength, and the hemoglobin concentration
6)计算血流量BF:通过测试放入被测部位后的近端热敏电阻和远端热敏电阻值,得到传热棒两端的温度变化曲线,计算这两条曲线的平均面积的差值,利用公式(4)计算出血流量,6) Calculation of blood flow BF: By testing the value of the proximal thermistor and the distal thermistor after being placed in the measured part, the temperature change curve at both ends of the heat transfer rod is obtained, and the difference between the average areas of the two curves is calculated , using the formula (4) to calculate the bleeding flow,
式中,BF是血流量,as′、av为常数,Tj1为传热棒近端在测试开始时刻的温度,Tj2为传热棒近端在测试结束时刻的温度,t1为有效数据起始时间点,t2为有效数据的结束时间点,S1为传热棒近端温度平均值,S2为传热棒远端温度平均值;where BF is the blood flow, a s′ and a v are constants, T j1 is the temperature at the near end of the heat transfer rod at the beginning of the test, T j2 is the temperature at the end of the test at the near end of the heat transfer rod, t 1 is the starting time point of valid data, t 2 is the end time point of valid data, S 1 is the average temperature at the proximal end of the heat transfer rod, and S 2 is the average temperature at the far end of the heat transfer rod;
7)血糖值的计算:考虑人的身高、体重、年龄的影响对模型的影响,血糖值用公式(5)进行计算:7) Calculation of blood sugar level: Considering the impact of people's height, weight and age on the model, the blood sugar level is calculated using formula (5):
G=f(H,BF,SpO2,Hgb,High,Weight,Age) (5)G=f(H,BF,SpO 2 ,Hgb,High,Weight,Age) (5)
其中,H为人体代谢产生的热量,通过环境温湿度、人体温湿度、血流量、脉搏计算得到,H=g(T1,T2,H1,H2,BF,Pulse);Among them, H is the heat generated by human metabolism, which is calculated from the environment temperature and humidity, body temperature and humidity, blood flow, and pulse, H=g(T 1 , T 2 , H 1 , H 2 , BF, Pulse);
8)将步骤2)~步骤7)中测量和计算得到的数据储存到储存单元,并通过串接口发送到生理参数检测模块,生理参数检测模块将数据发送到用户交互模块,实现人机交互功能。8) Store the data measured and calculated in steps 2) to 7) in the storage unit, and send them to the physiological parameter detection module through the serial interface, and the physiological parameter detection module sends the data to the user interaction module to realize the human-computer interaction function .
本发明与现有技术相比,具有以下优点及突出性效果:①选取安卓平台来配合设计人机交互接口,一方面弥补digital signal processing(DSP)开发人机接口的弱势,另一方面基于安卓平台的应用交互性优良,扩展性强,开发周期短,能便捷的开发用户体验良好的客户端程序;②同时检测人体多项生理参数指标,实现了检测系统的高度集成,并且实现了人体血糖浓度的无创测量;③整合了环境温湿度等各个检测参数,改进了传热棒的形状和工艺,有效提高了检测精度。Compared with the prior art, the present invention has the following advantages and outstanding effects: ① select the Android platform to cooperate with the design of the human-computer interaction interface, on the one hand to make up for the weakness of digital signal processing (DSP) in developing the human-computer interface, on the other hand, based on Android The platform has excellent application interaction, strong scalability, short development cycle, and can easily develop client programs with good user experience; ②simultaneously detect multiple physiological parameters of the human body, realizing a high degree of integration of the detection system, and realizing Non-invasive measurement of concentration; ③Integrates various detection parameters such as ambient temperature and humidity, improves the shape and process of the heat transfer rod, and effectively improves the detection accuracy.
附图说明Description of drawings
图1是本发明提供的多参数生理指征检测装置的硬件框图。Fig. 1 is a hardware block diagram of a multi-parameter physiological indicator detection device provided by the present invention.
图2是多参数生理指征检测装置探头的结构示意图。Fig. 2 is a structural schematic diagram of a probe of a multi-parameter physiological indication detection device.
图3是温度测量电桥原理图。Figure 3 is a schematic diagram of the temperature measurement bridge.
图4是脱氧血红蛋白、氧合血红蛋白和水的吸光系数随光频率变化。Figure 4 is the variation of the absorption coefficient of deoxyhemoglobin, oxyhemoglobin and water with light frequency.
图5是热传递法原理图。Figure 5 is a schematic diagram of the heat transfer method.
图6是传热棒两端信号实例。Figure 6 is an example of the signals at both ends of the heat transfer rod.
图7是多参数生理指征检测装置的传热棒结构示意图。Fig. 7 is a schematic structural diagram of the heat transfer rod of the multi-parameter physiological indication detection device.
图8是多参数生理指征检测装置的散热片结构(梳齿平板结构)示意图。Fig. 8 is a schematic diagram of the heat sink structure (comb-teeth plate structure) of the multi-parameter physiological indication detection device.
图9是多参数生理指征检测装置的人机交互流程图。Fig. 9 is a flow chart of the human-computer interaction of the multi-parameter physiological sign detection device.
图中:1-顶盖;2-红外光发射阵列;3-散热片;4-底座;5-电路板;6-红外光接收器;7-远端热敏电阻;8-传热棒;9-近端热敏电阻;10-湿度传感器;11-红外辐射传感器;12-下接触座板;81-金层。In the figure: 1-top cover; 2-infrared light emitting array; 3-heat sink; 4-base; 5-circuit board; 6-infrared light receiver; 7-remote thermistor; 8-heat transfer rod; 9-proximal thermistor; 10-humidity sensor; 11-infrared radiation sensor; 12-lower contact seat plate; 81-gold layer.
具体实施方式detailed description
下面结合附图和具体实施例对本发明进行详细说明。The present invention will be described in detail below in conjunction with the accompanying drawings and specific embodiments.
图1是本发明提供的多参数生理指征检测装置的硬件框图,该多参数生理指征检测装置包括探头和主机;所述探头包括多参数集成信号采集部件、传热部件和散热部件;所述多参数集成信号采集部件包含红外辐射传感器11、湿度传感器10、近端热敏电阻9、远端热敏电阻7、红外光发射阵列2和红外光接收器6;红外辐射传感器11用于检测体表和环境温度参数,湿度传感器10用于检测环境和体表湿度参数;近端热敏电阻9、远端热敏电阻7、红外光发射阵列2和红外光接收器6用于检测血流量参数,红外光发射阵列2和红外光接收器6还用于检测脉搏、血氧饱和度和血红蛋白参数,所述红外辐射传感器11和湿度传感器10等的检测参数均用来计算血糖参数。Fig. 1 is a hardware block diagram of a multi-parameter physiological indication detection device provided by the present invention, the multi-parameter physiological indication detection device includes a probe and a host; the probe includes a multi-parameter integrated signal acquisition component, a heat transfer component and a heat dissipation component; The multi-parameter integrated signal acquisition part includes an infrared radiation sensor 11, a humidity sensor 10, a near-end thermistor 9, a far-end thermistor 7, an infrared light emitting array 2 and an infrared light receiver 6; the infrared radiation sensor 11 is used to detect Body surface and ambient temperature parameters, humidity sensor 10 is used to detect environment and body surface humidity parameters; proximal thermistor 9, remote thermistor 7, infrared light emitting array 2 and infrared light receiver 6 are used to detect blood flow Parameters, the infrared light emitting array 2 and the infrared light receiver 6 are also used to detect pulse, blood oxygen saturation and hemoglobin parameters, and the detection parameters of the infrared radiation sensor 11 and humidity sensor 10 are used to calculate blood sugar parameters.
所述主机包括数据处理模块和平板电脑,所述数据处理模块包含微处理器、信号调理单元和存储单元;所述微处理器使用DSP处理芯片;所述信号调理单元包含放大滤波电路、A/D转换电路和积分电路;所述存储单元包含SD存储卡;多参数集成信号采集部件采集到的信号经信号调理单元处理后送入微处理器,由微处理器对信号进行计算处理,将计算结果送入存储单元存储;红外光发射阵列与微处理器的输出线路连接;所述平板电脑包括通信协议模块、生理参数检测模块、用户交互模块和触摸显示屏,采用ARM架构的安卓操作系统;所述通信协议模块实现数据处理模块和平板电脑之间的命令和数据通信;所述生理参数检测模块通过控制数据处理模块来控制多参数检测传感器集成探头,从而实现多参数检测传感器集成探头内各传感器对数据的采集;所述用户交互模块用于获取用户给出的检测指令,通过通信协议模块,获取生理参数检测模块结果;所述触摸显示屏用于所有控制操作,并显示所有检测参数,包括但不局限于环境温湿度、体表温湿度、脉搏、血氧饱和度、血流速度、血红蛋白浓度和血糖浓度。The host computer includes a data processing module and a tablet computer, and the data processing module includes a microprocessor, a signal conditioning unit and a storage unit; the microprocessor uses a DSP processing chip; the signal conditioning unit includes an amplification filter circuit, an A/ D conversion circuit and integration circuit; the storage unit includes an SD memory card; the signal collected by the multi-parameter integrated signal acquisition part is processed by the signal conditioning unit and sent to the microprocessor, and the signal is calculated and processed by the microprocessor, and the calculation result is calculated Send into storage unit storage; Infrared light emission array is connected with the output line of microprocessor; Described panel computer comprises communication protocol module, physiological parameter detection module, user interaction module and touch display screen, adopts the Android operating system of ARM framework; The communication protocol module realizes the command and data communication between the data processing module and the tablet computer; the physiological parameter detection module controls the multi-parameter detection sensor integration probe by controlling the data processing module, thereby realizing the multi-parameter detection sensor integration of each sensor in the probe The collection of data; the user interaction module is used to obtain the detection instructions given by the user, and obtain the results of the physiological parameter detection module through the communication protocol module; the touch display screen is used for all control operations and displays all detection parameters, including But not limited to ambient temperature and humidity, body surface temperature and humidity, pulse, blood oxygen saturation, blood flow velocity, hemoglobin concentration and blood sugar concentration.
所述数据处理模块和平板电脑通过串行接口连接,实现双向通信;所述探头与主机之间使用有线或无线进行通信连接,完成数据的传递。The data processing module and the tablet computer are connected through a serial interface to realize two-way communication; the probe and the host are connected by wired or wireless communication to complete data transmission.
图2是多参数生理指征检测装置探头的结构示意图,所述探头采用夹子结构,包括顶盖1、底座4、红外光发射阵列2、散热片3、电路板5、红外光接收器6、远端热敏电阻7、传热棒8、近端热敏电阻9、湿度传感器10、红外辐射传感器11、下接触座板12;所述红外光发射阵列2与红外光接收器6位于被测部位的两侧,并相对布置;所述近端热敏电阻9设于传热棒8靠近被测部位的一端,所述远端热敏电阻7设于传热棒8远离被测部位的一端;人体被测部位置于底座4和顶盖1之间;本发明所述的红外光发射阵列2设置于顶盖1中,所述的红外辐射传感器11、红外光接收器6和传热棒8设置于底座4中,并沿着人体待测部位方向排布。Fig. 2 is a structural schematic diagram of a probe of a multi-parameter physiological indication detection device, the probe adopts a clip structure, including a top cover 1, a base 4, an infrared light emitting array 2, a heat sink 3, a circuit board 5, an infrared light receiver 6, Far-end thermistor 7, heat transfer rod 8, near-end thermistor 9, humidity sensor 10, infrared radiation sensor 11, lower contact seat plate 12; described infrared light emitting array 2 and infrared light receiver 6 are located at the The two sides of the part are arranged oppositely; the proximal thermistor 9 is arranged at one end of the heat transfer rod 8 close to the measured part, and the distal thermistor 7 is arranged at the end of the heat transfer rod 8 away from the measured part The measured part of the human body is placed between the base 4 and the top cover 1; the infrared light emitting array 2 of the present invention is arranged in the top cover 1, and the infrared radiation sensor 11, the infrared light receiver 6 and the heat transfer rod 8 are arranged in the base 4 and arranged along the direction of the parts of the human body to be measured.
图9是平板电脑中用户交互模块的工作流程:开机启动程序,显示测试的主界面;在主界面有用户指南、新建用户、用户检测和帮助选项,用户第一次测试时需要新建一个用户;新建用户时需要输入用户的基本信息;新建用户完成或者点击用户检测之后出现选择用户的界面,选择本次测试对应的用户;之后需要选择用户的测试状态,如空腹、餐后2小时等;之后开始测试,DSP开始供电,检测DSP电源连接是否正确,主机向DSP发送测试指令和用户信息;DSP采集测试环境信息,如发现环境条件不适合继续测试,则向主机发送相关结果,结束本次测试;如环境条件合适则请用户放入被测部位(如手指,耳朵等),检测到放入被测部位后,DSP发送指令开始测试相关参数;测试完成后,DSP完成数据存储,并将各参数测试结果发送给主机,在平板电脑上显示;主机发送命令关闭DSP电源,测试结束。Fig. 9 is the workflow of the user interaction module in the tablet computer: start the program, display the main interface of the test; there are user guide, new user, user detection and help options in the main interface, and the user needs to create a new user when testing for the first time; When creating a new user, you need to enter the basic information of the user; after the creation of the user is completed or after clicking the user test, the user selection interface will appear, and select the user corresponding to this test; after that, you need to select the test status of the user, such as fasting, 2 hours after a meal, etc.; after that Start the test, DSP starts to supply power, check whether the DSP power supply is connected correctly, the host sends test instructions and user information to the DSP; DSP collects test environment information, if it finds that the environmental conditions are not suitable for continuing the test, it sends relevant results to the host to end this test ; If the environmental conditions are suitable, please put the user into the part to be tested (such as fingers, ears, etc.). The parameter test results are sent to the host and displayed on the tablet; the host sends a command to turn off the DSP power supply, and the test ends.
信号采集的具体工作流程是:DSP发布命令,检测探头开始采集数据,这时红外辐射传感器11和湿度传器10分别测量的是环境辐射温度和环境湿度,DSP检验测试到的环境参数是否合适,如果不合适向主机发送命令,终止这次测试,如果环境参数合适则将检测探头夹持于人体被测部位(如手指、耳朵等),红外辐射传感器11和湿度传感器10分别测量的是人体被测部位辐射温度信号和周围湿度信号,与此同时,传热棒8与被测部位(如手指、耳朵等)相接触,即发生热传递现象,由于温度发生变化,近端热敏电阳9与远端热敏电阻7的阻值会发生变化,该变化后的阻值信号被温度检测电路所检测;红外光发射阵列2发车的光波通过被测部位(如手指、耳朵等)后产生透射光谱信号A,由红外接收器6接收。The specific work flow of signal acquisition is: DSP issues order, and detection probe starts to collect data, and what infrared radiation sensor 11 and humidity transducer 10 measure respectively at this moment is ambient radiation temperature and ambient humidity, and DSP checks whether the environmental parameters tested are suitable, If it is inappropriate to send a command to the host, terminate this test, if the environmental parameters are suitable, the detection probe will be clamped on the measured parts of the human body (such as fingers, ears, etc.), and the infrared radiation sensor 11 and the humidity sensor 10 measure respectively the human body. The measurement site radiates temperature signals and surrounding humidity signals. At the same time, the heat transfer rod 8 is in contact with the site to be measured (such as fingers, ears, etc.), and heat transfer occurs. The resistance value of the remote thermistor 7 will change, and the changed resistance signal is detected by the temperature detection circuit; the light wave emitted by the infrared light emitting array 2 passes through the measured part (such as a finger, ear, etc.) to generate transmission The spectrum signal A is received by the infrared receiver 6 .
然后,这些测量元件测得的信号分为三路传送到微处理器:人体被测部位辐射温度信号、环境辐射温度度信号、被测部位周围湿度信号、环境湿度信号和压力信号通过传输线路依次经过放大滤波电路和A/D转换电路进入微处理器;近端热敏电阻9和远端热敏电阻7的阻值信号通过传输线进入温度检测电路,将电阻信号转变为温度信号,然后温度信号经放大滤波电路和A/D转换电路进入微处理器;透射光强信号Al~A4依次经过一阶放大滤波电路、积分电路以及二阶放大滤波电路进入微处理器。红外发光阵列的工作由发射器控制电路来控制,该发射器控制电路通过控制线路与DSP相连接;一阶放大滤波电路由电位器开关电路来控制,该电位器开关电路通过控制线路与DSP相连接;二阶放大滤波电路则直接通过控制线路与DSP相连接。这样,发射器控制电路、一阶放大滤波电路以及二阶放大滤波电路都受到DSP的控制。Then, the signals measured by these measuring elements are divided into three channels and sent to the microprocessor: the radiation temperature signal of the measured part of the human body, the ambient radiation temperature signal, the humidity signal around the measured part, the ambient humidity signal and the pressure signal through the transmission line in turn. Enter the microprocessor through the amplification and filtering circuit and the A/D conversion circuit; the resistance signals of the near-end thermistor 9 and the far-end thermistor 7 enter the temperature detection circuit through the transmission line, and the resistance signal is converted into a temperature signal, and then the temperature signal Enter the microprocessor through the amplification and filtering circuit and A/D conversion circuit; the transmitted light intensity signals Al~A4 enter the microprocessor through the first-order amplification and filtering circuit, the integration circuit and the second-order amplification and filtering circuit in turn. The work of the infrared light-emitting array is controlled by the transmitter control circuit, which is connected to the DSP through the control circuit; the first-order amplification filter circuit is controlled by the potentiometer switch circuit, and the potentiometer switch circuit is connected to the DSP through the control circuit. connection; the second-order amplification filter circuit is directly connected to the DSP through the control line. In this way, the transmitter control circuit, the first-order amplification and filtering circuit and the second-order amplification and filtering circuit are all controlled by the DSP.
在DSP的参与和控制之下,所有信号都传输到DSP中,这些信号按照本发明的多参数测量和计算方法得到最终结果。Under the participation and control of the DSP, all signals are transmitted to the DSP, and these signals obtain the final result according to the multi-parameter measurement and calculation method of the present invention.
各个参数的测试方法如下:The test method of each parameter is as follows:
(1)环境温度和人体温度的测量通过热敏电阻实现,热敏电阻的阻值会随着温度的升高而增加,满足关系:(1) The measurement of ambient temperature and human body temperature is realized by a thermistor, and the resistance value of the thermistor will increase as the temperature rises, satisfying the relationship:
其中,Rt是热敏电阻在T1温度下的阻值;R是热敏电阻在T2常温下的标称阻值;B是热敏电阻的常数参数。Among them, Rt is the resistance value of the thermistor at T1 temperature ; R is the nominal resistance value of the thermistor at T2 normal temperature; B is the constant parameter of the thermistor.
利用普通电阻和热敏电阻组成如图3所示的电桥,图中R1、R2、R3为普通电阻,RT是热敏电阻,V0、V1是测试点的电压值,当温度发生变化时热敏电阻的阻值发生变化,普通电阻的阻值变化较小,V0和V1的差值会发生变化,通过放大电路和AD转换电路得到电压的差值,进而得到环境和人体的温度值。Common resistors and thermistors are used to form the bridge shown in Figure 3. In the figure, R1, R2, and R3 are common resistors, RT is thermistor, V0 and V1 are the voltage values of the test points. When the temperature changes, the thermal The resistance value of the sensitive resistor changes, the resistance value of the ordinary resistor changes little, the difference between V0 and V1 changes, and the voltage difference is obtained through the amplification circuit and the AD conversion circuit, and then the temperature value of the environment and the human body is obtained.
(2)环境的湿度可以通过湿度传感器得到,湿度传感器已经有比较成熟的传感器芯片,直接对其输出的电压值进行放大和采样即可。(2) The humidity of the environment can be obtained through the humidity sensor. The humidity sensor already has a relatively mature sensor chip, and the output voltage value can be directly amplified and sampled.
(3)测量人体血氧饱和度和脉搏:利用光学方法测得,理论依据是朗伯-比尔法则,当光线照在某物质上时,入射光强I与出射光强I0之间有以下关系: (3) Measurement of human blood oxygen saturation and pulse: Measured by optical methods, the theoretical basis is the Lambert-Beer law, when the light shines on a substance, the incident light intensity I and the outgoing light intensity I 0 have the following relation:
对I和I0的比值取对数得光密度A,即:Take the logarithm of the ratio of I and I 0 to obtain the optical density A, namely:
A=ln(I/I0)=εcdA=ln(I/I 0 )=εcd
通过红外光发射阵列发射四个波长的红外光,波长分别为660nm、730nm、800nm和940nm,利用红外接收器接收透过被测部位后的光信号,利用公式(1)得到人体血氧饱和度,Emit four wavelengths of infrared light through the infrared light emitting array, the wavelengths are 660nm, 730nm, 800nm and 940nm respectively, use the infrared receiver to receive the optical signal after passing through the measured part, and use the formula (1) to obtain the human blood oxygen saturation ,
SpO2=α2×R2+α1×R+α0 (1)SpO 2 =α 2 ×R 2 +α 1 ×R+α 0 (1)
其中,SpO2为人体血氧饱和度,α0=100.72,α1=10.28,α2=-26.67, 和分别为660nm和940nm波长的出射光强随脉搏变化的最小值,和分别为660nm和940nm波长出射光强随脉搏变化的最大值;Among them, SpO 2 is the oxygen saturation of human blood, α 0 =100.72, α 1 =10.28, α 2 =-26.67, and They are the minimum value of the output light intensity of 660nm and 940nm wavelengths changing with the pulse, and They are the maximum value of the output light intensity at 660nm and 940nm wavelengths changing with the pulse;
根据出射光强的变化频率计算得到脉搏Pulse;According to the intensity of the emitted light Change the frequency to calculate the pulse Pulse;
(4)血红蛋白浓度(4) Hemoglobin concentration
人体血液里的水占70%~85%左右,对正常人血红蛋白浓度占11%~15%,可知人体血液的主要成分为水和血红蛋白。其他成分在血液里的百分比不到19%。可以做如下假设:Water in human blood accounts for about 70% to 85%, and accounts for 11% to 15% of normal human hemoglobin concentration. It can be seen that the main components of human blood are water and hemoglobin. The percentage of other components in the blood is less than 19%. The following assumptions can be made:
(a)血液的大部分成分为水和血红蛋白。(a) Blood is mostly composed of water and hemoglobin.
(b)正常情况下血的密度为常数(正常情况下人的全血密度为1.048g/ml,红细胞密度为1.085g/ml,血浆密度为1.019g/ml,且血浆密度变化较小)。(b) Under normal circumstances, the density of blood is constant (under normal circumstances, the density of whole blood is 1.048g/ml, the density of red blood cells is 1.085g/ml, and the density of plasma is 1.019g/ml, and the change of plasma density is small).
(c)由散射引起的光衰减和通过血管的光的平均光程跟波长关系不大血液成分中各浓度之间关系如公式(2)所示,(c) The light attenuation caused by scattering and the average optical path of the light passing through the blood vessel have little relationship with the wavelength. The relationship between the concentrations of blood components is shown in formula (2),
其中,C0为血液浓度,CHb为脱氧血红蛋白浓度,为氧结合血红蛋白浓度,为水浓度,Cother为剩余成分的浓度。Among them, C 0 is the blood concentration, CHb is the concentration of deoxygenated hemoglobin , is the oxygen-bound hemoglobin concentration, is the concentration of water, and C other is the concentration of the remaining components.
由于人体组织比较复杂,对光存在着强散射现象,大量的统计结果表明,由于散射的影响,光子从入射光源到光电检测器之间为随机迁移过程,光线总的传播路径为“弯弓”型,因此朗伯-比尔定律需要修正。在强散射下的吸收定律可以近似的表示为:Due to the complexity of human tissue, there is a strong scattering phenomenon for light. A large number of statistical results show that due to the influence of scattering, photons migrate randomly from the incident light source to the photodetector, and the total propagation path of light is "bow". type, so the Lambert-Beer law needs to be revised. The absorption law under strong scattering can be approximated as:
其中,S为组织成分散射引起的衰减因子,dpef为光线路径修正因子,c为被测组织成分的浓度,d为光穿透的路径长度,ε为组织成分的吸光系数。Among them, S is the attenuation factor caused by tissue component scattering, d pef is the light path correction factor, c is the concentration of the measured tissue component, d is the path length of light penetration, and ε is the light absorption coefficient of the tissue component.
求解方程(3)得到CHb和 Solving equation (3) to get CHb and
其中,S为组织成分散射引起的衰减因子,由于剩余成分的浓度和散射引起的衰减相对较小,把看成常数,ε表示物质在特定波长下的吸光系数,I0表示入射光的光强,I表示透过被测部位后的光强,dpef是特定波长下的路径修正因子,血红蛋白浓度图4给了波长范围在700~1300nm脱氧血红蛋白、氧合血红蛋白和水的吸光系数变化。选用660nm、730nm、800nm、940nm四个波长来进行测量。根据测得的光强值就可以计算出血红蛋白浓度。in, S is the attenuation factor caused by the scattering of tissue components, because the concentration of the remaining components and the attenuation caused by scattering are relatively small, put As a constant, ε represents the absorption coefficient of the substance at a specific wavelength, I 0 represents the light intensity of the incident light, I represents the light intensity after passing through the measured part, d pef is the path correction factor at a specific wavelength, and the hemoglobin concentration Figure 4 shows the changes in the absorption coefficients of deoxyhemoglobin, oxyhemoglobin and water in the wavelength range of 700-1300nm. Four wavelengths of 660nm, 730nm, 800nm and 940nm are selected for measurement. According to the measured light intensity value, the hemoglobin concentration can be calculated.
(5)血流量利用热传递法进行测量(5) Blood flow is measured by heat transfer method
图5中传热棒两端安装有热敏电阻,传热棒温度低于组织温度,将传热棒一端与被测部位表面接触以后,被测部位表面与传热棒之间会产生热量传递,进而使被测部位温度发生变化。传热棒上任意点的温度变化量依赖于从被测部位到传热棒的热传递量,而热传递的热量最终取决于毛细血管中的血流量。因此,通过测量传热棒上任意点的温度变化,就可以推算出血流量。In Figure 5, thermistors are installed at both ends of the heat transfer rod, and the temperature of the heat transfer rod is lower than the tissue temperature. After one end of the heat transfer rod is in contact with the surface of the measured part, heat transfer will occur between the surface of the measured part and the heat transfer rod , so that the temperature of the measured part changes. The amount of temperature change at any point on the heat transfer rod depends on the amount of heat transfer from the measured site to the heat transfer rod, and the amount of heat transferred ultimately depends on the blood flow in the capillaries. Therefore, by measuring the temperature change at any point on the heat transfer rod, the bleeding flow rate can be extrapolated.
图6为通过传感器采集的数据计算得到传热棒两端的温度变化曲线,横轴是时间,纵轴是温度值,上方虚线为近端温度传感器数值,下方实线为远端温度传感器值。血流量BF可以用公式(4)表示:Figure 6 is the temperature change curve at both ends of the heat transfer rod calculated through the data collected by the sensor. The horizontal axis is time and the vertical axis is temperature value. Blood flow BF can be expressed by formula (4):
式中,BF是血流量,as′、av为常数,Tj1为传热棒近端在测试开始时刻的温度,Tj2为传热棒近端在测试结束时刻的温度,t1为有效数据起始时间点,t2为有效数据的结束时间点,S1为传热棒近端温度平均值,S2为传热棒远端温度平均值。where BF is the blood flow, a s′ and a v are constants, T j1 is the temperature at the near end of the heat transfer rod at the beginning of the test, T j2 is the temperature at the end of the test at the near end of the heat transfer rod, t 1 is the starting time point of valid data, t 2 is the end time point of valid data, S 1 is the average temperature at the proximal end of the heat transfer rod, and S 2 is the average temperature at the far end of the heat transfer rod.
在传热棒两端温度测试中,即使采用高精度电路设计,仍然存在一定的测试误差,所述装置利用环境温度估计值对每个温度传感器进行偏移量校正,提高精度。In the temperature test at both ends of the heat transfer rod, even if a high-precision circuit design is adopted, there is still a certain test error. The device uses the estimated value of the ambient temperature to correct the offset of each temperature sensor to improve the accuracy.
图7为传热棒,其两端装有热敏电阻,为了更精确的测试血流量,传热棒的形状需要进行优化,经过仿真得到使用十字形结构时效果较好。一次测试完成后传热棒的余热需要尽快散去,以便尽快开始下一次测试,为此设计了梳齿平板散热装置,如图8所示。Figure 7 shows a heat transfer rod with thermistors installed at both ends. In order to test the blood flow more accurately, the shape of the heat transfer rod needs to be optimized. After simulation, it is better to use a cross-shaped structure. After a test is completed, the residual heat of the heat transfer rod needs to be dissipated as soon as possible so that the next test can be started as soon as possible. For this purpose, a comb-tooth plate heat sink is designed, as shown in Figure 8.
(6)人体血糖浓度利用代谢热整合法进行计算(6) Human blood glucose concentration is calculated using the metabolic heat integration method
代谢热整合血糖测试方法在2004年被Ok Kyung Cho等人提出。他们认为血液中的葡萄糖和氧在血液循环系统的作用下进入组织细胞中,然后经过氧化反应转化为能量、水和二氧化碳。大部分能量转换成热量,被转换的热量以对流和辐射两种方式散发到周围环境当中。因此人体代谢热量是血糖浓度、供氧量的函数并和血糖浓度、供氧量正相关,而通过测试散热量的方法可以预测代谢热。其理论认为人体体温的恒定由血糖氧化产热和热量耗散两部分的平衡来维持,并做如下假设:Metabolic heat integrated blood glucose testing method was proposed by Ok Kyung Cho et al. in 2004. They believe that the glucose and oxygen in the blood enter the tissue cells under the action of the blood circulatory system, and then convert into energy, water and carbon dioxide through oxidation reactions. Most of the energy is converted into heat, and the converted heat is dissipated to the surrounding environment in two ways: convection and radiation. Therefore, the metabolic heat of the human body is a function of the blood sugar concentration and the oxygen supply and is positively correlated with the blood sugar concentration and the oxygen supply, and the metabolic heat can be predicted by testing the heat dissipation. Its theory holds that the constant body temperature is maintained by the balance of blood sugar oxidation heat production and heat dissipation, and makes the following assumptions:
1)机体在静态下代谢产热量与散热量可视为相等。1) The metabolic heat production and heat dissipation of the body can be regarded as equal under static conditions.
2)代谢产热量是血糖浓度和供氧量的函数。2) Metabolic heat production is a function of blood glucose concentration and oxygen supply.
3)供氧量是血氧饱和度和局部组织血流量的函数。3) Oxygen supply is a function of blood oxygen saturation and local tissue blood flow.
4)人体散热主要由对流、辐射两种形式完成。4) The heat dissipation of the human body is mainly completed by convection and radiation.
根据假设可知,代谢热量为血糖浓度值和氧供给量的函数,氧供给量又由血氧饱和度、血红蛋白浓度和局部组织的血流量决定,因此代谢产热量为血糖浓度值、血氧饱和度、血红蛋白浓度和血流量的函数,并可用下式表示:According to the hypothesis, it can be known that metabolic heat is a function of blood glucose concentration and oxygen supply, and oxygen supply is determined by blood oxygen saturation, hemoglobin concentration, and blood flow in local tissues. Therefore, metabolic heat production is the function of blood glucose concentration, blood oxygen saturation , a function of hemoglobin concentration and blood flow, and can be expressed as follows:
H=f0(G,BF,SpO2,Hgb)H=f 0 (G,BF,SpO 2 ,Hgb)
式中:H为代谢热量,BF为血流量,SpO2为血氧饱和度,Hgb为血红蛋白浓度,G为血糖浓度值。若测得代谢热量、血氧饱和度和血流量,考虑人的身高、体重、年龄的影响对模型的影响,血糖值用公式(5)进行计算:In the formula: H is metabolic heat, BF is blood flow, SpO2 is blood oxygen saturation, Hgb is hemoglobin concentration, and G is blood glucose concentration. If the metabolic heat, blood oxygen saturation and blood flow are measured, the blood sugar value is calculated using the formula (5) considering the influence of the person's height, weight and age on the model:
G=f(H,BF,SpO2,Hgb,High,Weight,Age) (5)G=f(H,BF,SpO 2 ,Hgb,High,Weight,Age) (5)
其中,H为人体代谢产生的热量,通过环境温湿度、人体温湿度、血流量、脉搏计算得到,H=g(T1,T2,H1,H2,BF,Pulse)。Among them, H is the heat generated by human metabolism, which is calculated from the environment temperature and humidity, body temperature and humidity, blood flow, and pulse, H=g(T 1 , T 2 , H 1 , H 2 , BF, Pulse).
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