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CN1297229C - Non-invasive detection device of pulse impedance spectrum blood sugar or other biood component and its detection method - Google Patents

Non-invasive detection device of pulse impedance spectrum blood sugar or other biood component and its detection method Download PDF

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CN1297229C
CN1297229C CNB200410020169XA CN200410020169A CN1297229C CN 1297229 C CN1297229 C CN 1297229C CN B200410020169X A CNB200410020169X A CN B200410020169XA CN 200410020169 A CN200410020169 A CN 200410020169A CN 1297229 C CN1297229 C CN 1297229C
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blood
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control unit
blood sugar
measurement
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CN1596826A (en
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李刚
卢宗武
林凌
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Tianjin University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14532Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body

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Abstract

本发明公开了一种脉搏阻抗谱血糖或其他血液成分的无创检测装置及其检测方法,本发明的检测装置由主控单元以及与主控单元连接的扫频恒流源、测量单元、显示报警单元、存储单元和通讯接口构成。扫频恒流源设置有一对激励电极,测量单元设置有一对测量电极,主控单元用于对整个测量系统进行控制,对动态脉搏波阻抗谱数据进行处理,由此计算血糖和其它血液成分的浓度。本发明的检测方法包括步骤:通过测量动态脉搏波阻抗谱,得到主要由于动脉血液脉动产生动脉阻抗谱,进而消除个体差异的影响,得到血糖或其他血液成分的浓度。本发明能够减小了测量误差,提高了信噪比和灵敏度,能够同时实现血糖和其它多种血液成分的无创、实时、连续自我监测。

The invention discloses a pulse impedance spectrum non-invasive detection device for blood sugar or other blood components and a detection method thereof. The detection device of the invention is composed of a main control unit, a frequency-sweeping constant current source connected to the main control unit, a measurement unit, a display alarm unit, storage unit and communication interface. The frequency-sweeping constant current source is provided with a pair of excitation electrodes, and the measurement unit is provided with a pair of measurement electrodes. The main control unit is used to control the entire measurement system and process the dynamic pulse wave impedance spectrum data, thereby calculating blood glucose and other blood components. concentration. The detection method of the present invention includes the steps of: obtaining the arterial impedance spectrum mainly due to arterial blood pulsation by measuring the dynamic pulse wave impedance spectrum, and then eliminating the influence of individual differences to obtain the concentration of blood sugar or other blood components. The invention can reduce the measurement error, improve the signal-to-noise ratio and sensitivity, and simultaneously realize the non-invasive, real-time and continuous self-monitoring of blood sugar and other blood components.

Description

The noninvasive detection device of pulse impedance spectrum blood glucose or other blood constituents and detection method thereof
Technical field
The present invention relates to checkout gear and detection method thereof that a kind of Woundless blood sugar or other blood constituents detect, specifically, relate to a kind of by measuring the body surface electrical impedance and realizing the checkout gear and the detection method thereof of blood glucose or other blood constituent non-invasive measurement with the variation of pulse wave.
Background technology
Diabetes are a kind of chronic metabolic diseases, and its cause of disease is heredity, hypoinsulinism or insulin hypofrontality.Disease shows as blood sugar concentration at first and raises, and then other organs of harmful to human and system, causes severe complications such as renal failure, blind, heart disease, extremity peripheral neuralgia, gangrene even excision.Diabetes have become the killer of serious threat human health.World's diabetics in 2000 is that 1.8 hundred million, 3,200,000 people die from diabetes and complication thereof.Expectation the year two thousand thirty world's diabetics will reach 3.7 hundred million, and China's diabetics will reach forty-two million, occupy the second in the world, and the expenditure that is used for the treatment of diabetes will become society and heavy family burden.At present also not have thoroughly to effect a radical cure the medical approaches of diabetes, so monitor blood sugar concentration frequently, the consumption of in time adjusting hypoglycemic medicine is to preventing and what alleviate complication is vital.Conventional detection need be taken a blood sample, and uses instruments such as biochemistry, optics and analyzes, and not only complex operation, meeting cause pain to the patient, but also the danger of infecting other disease is arranged, and have limited the frequency and the scope of application of blood sugar test.Blood glucose noinvasive detection technique not only can be carried out real-time, continuous, safe, painless self-monitoring to blood sugar level, and do not need consumable goods, can reduce testing expense, will bring revolutionary progress, more and more be subject to people's attention to the prevention and the treatment of diabetes.
In recent years, along with progressively going deep into of every technical foundation theoretical research and enriching day by day of experimental result, screening to several technology of tool DEVELOPMENT PROSPECT is finished substantially, and they can be divided into three major types: optical radiation technology, bio-impedance technology and humor collecting technology.
The optical radiation technology comprises middle near infrared spectroscopy, far red light spectrometry, polarimetry, light scattering coefficient method etc., and what wherein research input was maximum is near infrared spectroscopy.The ultimate principle of optical radiation method is the light energy that applies certain wavelength at the human body specific part, by measuring tissue parameters such as the absorption of light energy, reflection, scattering, polarization are changed, set up the relation of blood constituent such as blood glucose and these parameters, handle the concentration that calculates blood glucose.These methods all have tempting research and commercial promise, and also facing simultaneously many great technical barriers needs to solve, and distinct issues are that the spectral device that is used to detect must often be calibrated again.The instrument that many people use can need be set up specific many reference amounts forecast model to each experimenter owing to the difference of compositions such as moisture, fat, muscle, skin, skeleton in each human body.Even same experimenter, more than each composition make also that with the regular variation of physiological process frequent calibration is inevitable, and the process of each calibration was both tediously long and wound arranged, common 1-2 consuming time hour and need continuous blood extracting assay.
The humor collecting method comprises iontophoresis method and interstitial fluid transdermal collecting method.The iontophoresis method is to apply weak current at skin surface, will have body fluid to ooze out near the electrode.Concentration of glucose in these body fluid is relevant with blood sugar concentration, and the concentration of glucose in the measurement transudate can be extrapolated the content of glucose in the blood.Interstitial fluid transdermal collecting method is to adopt the method for micropin, chemistry or laser to collect the skin surface cell interstitial fluid, measures the concentration of glucose of these liquid then.The shortcoming one of these two kinds of methods be the humor collecting time more than 20 minutes, can not reflect the variation of blood sugar concentration in real time; The 2nd, skin there is certain damage.
The detection technique of the biomedical information that the bio-impedance technology is a kind of electrical characteristics of utilizing biological tissue and organ and Changing Pattern extraction thereof and Human Physiology, pathological condition is relevant.The bio-electrical impedance technology is extracted is the electrical characteristics information that the changes of function with tissue and organ interrelates, blood, gas, body fluid and different tissues composition and variation thereof etc. are had unique resolving ability, therefore can utilize the biological impedance technology to realize the non-invasive measurement of blood glucose and other composition.
Impedance is meant that material is to passing through whole inhibitions of alternating current wherein.When this alternating current put on blood, the inorganic solute as the glucose wherein will absorption of electromagnetic energy, thereby caused impedance to raise, and its size is relevant with concentration of glucose.Glucose is also inequality to the influence of blood impedance under the different frequency.Therefore,, suitably select several frequencies, can accurately obtain blood sugar concentration by measuring the impedance of blood.The A.Caduff of Pendragon company etc. carries out sweep measurement with the 0.1MHz step-length to the impedance of arm in the 1-200MHz frequency range, and compare with the blood sugar concentration that records, developed the impedance spectrum blood sugar monitoring instrument, can be worn at and monitor change of blood sugar on the wrist in real time.U.S. Pat 6517482 (H.R.Elden etc.) discloses a kind of blood glucose personal monitoring instrument, adopts the 20kHz frequency, has provided blood sugar concentration G=0.31 * modulus of impedance value+0.24 * phase angle, and the measuring point is a forearm.
Impedance method blood glucose non-invasive measurement method instrument cost is low, the measuring accuracy height, and required time is short.In addition, if suitably select frequency, can also detect the concentration of a plurality of compositions such as cholesterol simultaneously.Therefore, impedance spectrum measurement Woundless blood sugar detects and has very vast potential for future development.
Human body impedance is subjected to the influence of skin, blood circulation situation, blood electrolyte and other many factors that become to grade equally, and these factors are referred to as individual variation.Because the existence of individual variation makes the monitoring of impedance spectrum Woundless blood sugar have very large deviation, signal to noise ratio and sensitivity to be difficult to improve.
Summary of the invention
Technical problem to be solved by this invention is, overcomes the deficiency in existing impedance method blood glucose or other blood constituent noinvasive detection techniques, provides that a kind of error is little, signal to noise ratio and highly sensitive blood glucose or other blood constituent noninvasive detection devices; Another object of the present invention provides that a kind of error is little, signal to noise ratio and highly sensitive blood glucose or other blood constituent noinvasive detection methods.
For solving the problems of the technologies described above, the noninvasive detection device of pulse impedance spectrum blood glucose of the present invention or other blood constituents is made of main control unit and the frequency sweep constant-current source that is connected with main control unit, measuring unit, display alarm unit and memory element; Described frequency sweep constant-current source is provided with pair of exciting, and the frequency sweep constant-current source is used to produce the faint alternating current of changeable frequency constant amplitude, and by described exciting electrode feed-in human body; Described measuring unit is provided with a pair of measurement electrode, and measurement electrode is used to pick up the amplitude of the impedance pulse wave under the different frequency, and sends into main control unit; Described main control unit is used for whole measuring system is controlled, and dynamic pulse wave impedance spectrum data are handled, and calculates the concentration of blood glucose and other blood constituent thus, and data are sent into described display alarm unit and described memory element; Described display alarm unit receives and also to show the blood constituent data that main control unit is sent here, sends alarm signal when blood glucose or other blood constituents exceed standard; Described memory element is used to store Monitoring Data.
Described exciting electrode is ring electrode or cardiac monitoring electrode.
Described measurement electrode is ring electrode or cardiac monitoring electrode.
Described main control unit is microprocessor or microcontroller or pico computer.
Described memory element is a solid-state memory Flash chip.
Described communication interface is usb communication interface or RS232 communication interface, is used for blood glucose or other blood constituent data of storage are sent to other devices or equipment
For solving the problems of the technologies described above, the noinvasive detection method of pulse impedance spectrum blood glucose of the present invention or other blood constituents may further comprise the steps:
Exciting electrode is placed on people's arm, finger, trunk or lower limb position, applies the faint alternating current of frequency adjustable constant amplitude to human body;
Measurement electrode is positioned between the exciting electrode, picks up two voltage signals between the cross section; Obtain dynamic pulse wave impedance spectrum by the amplitude of measuring impedance pulse wave under the different frequency:
Δ Z Fi, i=0,1,2,3 ..., N is in the formula: f iRepresent different driving frequencies, thereby obtain producing the tremulous pulse impedance spectrum mainly due to the arterial blood pulsation;
The frequency f of selected one of them signal 0As reference frequency, calculate:
k i = ΔZ f i ΔZ f 0 , i = 1,2,3 . . . N , This ratio is only relevant with the resistivity of blood, and irrelevant with external factor such as skin, situation, electrode polarization voltages, has eliminated the influence of individual variation;
By the relation of determining between blood resistivity and blood constituent: ρ=ρ (c 1, c 2, c 3... c i), c in the formula 1, c 2, c 3... c iBe the concentration of blood glucose and other blood constituent, can obtain the concentration of blood glucose or other blood constituent.
Compared with prior art, the present invention has following beneficial effect: the present invention is by measuring the body surface electrical impedance realizes blood glucose or other blood constituent non-invasive measurement with the variation of pulse wave method and apparatus, thereby eliminated the individual variation influence, reduced measurement error, improve signal to noise ratio and sensitivity, can realize the noinvasive of blood glucose and other multiple blood constituent, real-time, self-monitoring continuously simultaneously.
Description of drawings
Fig. 1 is a system construction drawing of the present invention.
Fig. 2 is dynamic pulse wave impedance spectrum schematic diagram
Reference numeral: 1 display alarm unit, 2 main control units, 3 memory element, 4 communication interfaces
5 frequency sweep constant-current sources, 6 human body 7 measuring units 8 exciting electrodes 9 measurement electrode to be measured
The specific embodiment
Below in conjunction with embodiment the present invention is described in detail.
As shown in Figure 1, the noninvasive detection device of pulse impedance spectrum blood glucose of the present invention or other blood constituents is made of main control unit 2 and the frequency sweep constant-current source 5 that is connected with main control unit 2, measuring unit 7, display alarm unit 1, memory element 3 and communication interface 4.Frequency sweep constant-current source 5 is provided with pair of exciting 8, and exciting electrode 8 adopts ring electrode or cardiac monitoring electrode.Frequency sweep constant-current source 5 is used to produce the faint alternating current of changeable frequency constant amplitude, and by exciting electrode 8 feed-in human bodies.Measuring unit 7 is provided with a pair of measurement electrode 9, and measurement electrode 9 adopts ring electrode or cardiac monitoring electrode.Measurement electrode 9 is used to pick up the amplitude of the impedance pulse wave under the different frequency, sends into main control unit 2 after the built-in A/D converter conversion of measuring unit.Main control unit 2 can be microprocessor, microcontroller or pico computer, main control unit 2 is used for whole measuring system is controlled, dynamic pulse wave impedance spectrum data are handled, calculate the concentration of blood glucose and other blood constituent thus, and data are sent into display alarm unit 1 and memory element 3.Display alarm unit 1 receives and also shows the blood constituent data that main control unit 2 is sent here, exceeds standard at blood glucose or other blood constituents and then sends alarm signal.Memory element 3 is made up of solid-state memory and control circuit, and solid-state memory adopts the Flash chip, and memory element 3 is used to store Monitoring Data.Communication interface 4 is the communication interface of USB, RS232 or other modes, and communication interface 4 is used for blood glucose or other blood constituent data of storage are sent to other devices or equipment.
The principle of checkout gear of the present invention is: the frequency sweep constant-current source produces the faint alternating current of frequency adjustable constant amplitude, puts on human body by pair of exciting; Electrode adopts ring electrode or cardiac monitoring electrode, and rest can be arm, finger, trunk or lower limb; Measurement electrode is positioned between the exciting electrode, picks up two voltage signals between the cross section; Measuring unit obtains the impedance pulse wave under the different frequency with this voltage signal through amplification, filtering, sends into main control unit after the A/D conversion; The present invention's impedance pulse amplitude value defined that these different frequencies are corresponding down is dynamic pulse wave impedance spectrum.Main control unit is handled impedance pulse wave data, obtains dynamic pulse wave impedance spectrum:
ΔZ fi,i=0,1,2,3,...,N (1)
f iRepresent different driving frequencies.Selected frequency f 0As reference frequency, ratio then:
k i = Δ Z f i ΔZ f 0 , i = 1,2,3 . . . N - - - ( 2 )
Only relevant with the resistivity of blood.Definite relation is arranged between blood resistivity and blood constituent:
ρ=ρ(c 1,c 2,c 3,...c i) (3)
ρ is a blood resistivity, c 1, c 2, c 3... c iConcentration for different blood constituents.Can measure the various composition relation curves of blood resistivity and blood glucose or other in advance by a large amount of measurings and certain data processing means.Fig. 2 is an impedance pulse wave sketch map under certain frequency, and wherein Δ Z represents pulse wave amplitude, Z 0Be the human body basal impedance.
Main control unit draws the concentration of blood glucose or other composition according to the dynamic pulse wave impedance spectrum data that record and these curve calculation, and data are sent into display alarm unit and memory element; The display alarm unit receives and the demonstration main control unit sends blood glucose or other blood constituent data.If blood glucose or other blood constituent concentration over-standards then send alarm signal; Memory element is made up of solid-state memory and control circuit, can store blood glucose or other blood constituent concentration datas of a period of time; Communication interface is realized the communication of main control unit and microcomputer, the data in the memory element is sent to microcomputer does further to analyze and handle.
The noinvasive detection method of pulse impedance spectrum blood glucose of the present invention or other blood constituents may further comprise the steps:
Exciting electrode is placed on people's arm, finger, trunk or lower limb position, applies the faint alternating current of frequency adjustable constant amplitude to human body;
Measurement electrode is positioned between the exciting electrode, picks up two voltage signals between the cross section; Obtain dynamic pulse wave impedance spectrum by the amplitude of measuring impedance pulse wave under the different frequency:
Δ Z Fi, i=0,1,2,3 ..., N is in the formula: f iRepresent different driving frequencies, thereby obtain producing the tremulous pulse impedance spectrum mainly due to the arterial blood pulsation;
The frequency f of selected one of them signal 0As reference frequency, calculate:
k i = ΔZ f i ΔZ f 0 , i = 1,2,3 . . . N , This ratio is only relevant with the resistivity of blood, and irrelevant with external factor such as skin, situation, electrode polarization voltages, has eliminated the influence of individual variation;
By the relation of determining between blood resistivity and blood constituent: ρ=ρ (c 1, c 2, c 3... c i), c in the formula 1, c 2, c 3... c iBe the concentration of blood glucose and other blood constituent, can obtain the concentration of blood glucose or other blood constituent.
The present invention is by measuring the body surface electrical impedance and realizing the checkout gear and the detection method of blood glucose or other blood constituent non-invasive measurement with the variation of pulse wave, thereby eliminated the individual variation influence, reduced measurement error, improve signal to noise ratio and sensitivity, can realize the noinvasive of blood glucose and other multiple blood constituent, real-time, self-monitoring continuously simultaneously.

Claims (6)

1.一种脉搏阻抗谱血糖或其他血液成分的无创检测装置,其持征是,它由主控单元以及与主控单元连接的扫频恒流源、测量单元、显示报警单元、存储单元和通讯接口构成;所述的扫频恒流源设置有一对激励电极,扫频恒流源用于产生频率可变幅值恒定的微弱交变电流,并通过所述的激励电极馈入人体;所述的测量单元设置有一对测量电极,测量电极用于拾取不同频率下的阻抗脉搏波的幅值,并送入主控单元;所述的主控单元用于对整个测量系统进行控制,对动态脉搏波阻抗谱数据进行处理,由此计算血糖和其它血液成分的浓度,并将数据送入所述的显示报警单元和所述的存储单元:所述的显示报警单元接收并显示主控单元送来的血液成分数据,在血糖或其他血液成分超标时发出报警信号;所述的存储单元用于存储监测数据。1. A non-invasive detection device for pulse impedance spectrum blood sugar or other blood components. Its main feature is that it consists of a main control unit and a frequency-sweeping constant current source connected to the main control unit, a measurement unit, a display alarm unit, a storage unit and A communication interface is formed; the frequency-sweeping constant-current source is provided with a pair of excitation electrodes, and the frequency-sweeping constant-current source is used to generate a weak alternating current with variable frequency and constant amplitude, which is fed into the human body through the excitation electrodes; The measurement unit described above is provided with a pair of measurement electrodes, and the measurement electrodes are used to pick up the amplitudes of impedance pulse waves at different frequencies and send them to the main control unit; the main control unit is used to control the entire measurement system and control the dynamic Process the pulse wave impedance spectrum data, thereby calculate the concentration of blood sugar and other blood components, and send the data to the display alarm unit and the storage unit: the display alarm unit receives and displays the main control unit The incoming blood component data sends out an alarm signal when the blood sugar or other blood components exceed the standard; the storage unit is used for storing monitoring data. 2.根据权利要求1所述的一种脉搏阻抗谱血糖或其他血液成分的无创检测装置,其持征是,所述的激励电极是环状电极或者心电监护电极。2. A device for non-invasive detection of blood sugar or other blood components by pulse impedance spectroscopy according to claim 1, wherein the excitation electrode is a ring electrode or an electrocardiographic monitoring electrode. 3.根据权利要求1所述的一种脉搏阻抗谱血糖或其他血液成分的无创检测装置,其持征是,所述的测量电极是环状电极或心电监护电极。3. A device for non-invasive detection of blood sugar or other blood components by pulse impedance spectroscopy according to claim 1, wherein the measurement electrode is a ring electrode or an electrocardiographic monitoring electrode. 4.根据权利要求1所述的一种脉搏阻抗谱血糖或其他血液成分的无创检测装置,其持征是,所述的主控单元是微处理器或者微控制器或者微计算机。4. A device for non-invasive detection of blood sugar or other blood components by pulse impedance spectroscopy according to claim 1, wherein said main control unit is a microprocessor or a microcontroller or a microcomputer. 5.根据权利要求1所述的一种脉搏阻抗谱血糖或其他血液成分的无创检测装置,其持征是,所述的存储单元是固态存储器Flash芯片。5. A device for non-invasive detection of blood sugar or other blood components by pulse impedance spectroscopy according to claim 1, wherein said storage unit is a solid-state memory Flash chip. 6.根据权利要求1所述的一种脉搏阻抗谱血糖或其他血液成分的无创检测装置,其持征是,所述的通讯接口是USB通信接口或者RS232通信接口,用于将存储的血糖或其他血液成分数据传送到其他装置或设备。6. A non-invasive detection device for pulse impedance spectrum blood glucose or other blood components according to claim 1, wherein said communication interface is a USB communication interface or an RS232 communication interface, which is used to transfer stored blood glucose or Other blood composition data is transmitted to other devices or equipment.
CNB200410020169XA 2004-07-27 2004-07-27 Non-invasive detection device of pulse impedance spectrum blood sugar or other biood component and its detection method Expired - Fee Related CN1297229C (en)

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PCT/CN2005/000803 WO2006010310A1 (en) 2004-07-27 2005-06-08 Apparatus and method for non-invasive monitoring of blood components using pulsewave impedance spectra

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