CN101194838A - Non-invasive blood sugar detecting instrument - Google Patents
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Abstract
The invention discloses a non-invasive blood sugar detecting instrument which comprises a casing, a movement in the inner portion of the casing and a detecting head which is connected with the casing. The surface of the casing is provided with an operational push-button and an input key which marks the invasive blood sugar value, and the movement comprises a preamplifier, an A/D conversion circuit, a MCU system, a display, an acoustic prompting and warning circuit, a switch voltage stabilized source circuit, a power supply switch and an alternating current power supply socket. The detecting head is constituted by the connection of the temperature measuring contact of a temperature sensor on the front end and an ear notch accommodator on the rear portion, wherein the ear notch accommodator is constituted by a thermosensitive resistor temperature sensor on the middle portion, coated good heat conductor filling and metal shell, and the thermosensitive resistor temperature sensor is connected with a conversion circuit which transforms temperature signal into electrical signal and the preamplifier in the movement through wires. The invention solves the problems of non invasive, low cost and the precision detecting of blood sugar value.
Description
(1) technical field
The present invention relates to a kind of blood-sugar detecting instrument.
(2) background technology
Diabetes (diabetes mellitus) are the one group of Developmental and Metabolic Disorder syndromes that is caused by the h and E factor interaction, because of there are defective simultaneously in insulin secretion, insulin action or both, cause the metabolism disorder of carbohydrate, protein, fat, power and water Xie Zhi etc., clinical is main common trait with chronic (for a long time) hyperglycemia.Present global diabetics is about 1.32 hundred million, expects 2010 and can reach 2.4 hundred million, and newly-increased diabetics about 3/4 is in developing country.China has patient 2,000 ten thousand-3,0,000,000 at present, and the carbohydrate tolerance person of going down 3,000 ten thousand-4, and 0,000,000.These data also can increase with nearly ten million speed in every year.
The cause of disease of diabetes and pathogenesis are not clear fully as yet, lack effective etiological treatment method, therapeutic goal can only be to eliminate symptom, keeps normal quality of life and ability to work, prevent that acute metabolism disorder from prevention and delaying chronic and generation of freezing and development taking place.Therefore, treatment of diabetes is the process of lifelong participation.Except insulin and hypoglycemic medicine, diet control also is the basis for the treatment of diabetes, and these measures all be unable to do without correctly obtaining patient's blood glucose value.
At present, both at home and abroad the detection method about blood glucose has wound property mostly, adopts determination of glucose oxidase again after promptly need extracting blood samples of patients.Vein whole blood, blood plasma or serum glucose detect and carry out in hospital, the capillary tube full blood glucose detects available small-sized blood glucose meter and is tested oneself by patient. for reaching ideal glycemic control target, must carry out repeated detection in one day, comprise at least breakfast, lunch and dinner forward and backward and sleep before.Be suspected to have hypoglycemia at night, also need add survey.Though this class methods accuracy rate height also has inevitable shortcoming.At first be repeatedly to draw blood repeatedly every day to bring very big misery,, all need expensive glucoseoxidase reagent or reagent paper, so testing cost can cause bearing than large economy of patient no matter secondly be in the hospital or the self check of being in to patient.In addition, be in that self check may produce also that blood sampling is polluted and problems such as bacterial infection.So the scientific research institution of various countries and company are all at the blood sugar test technology and equipment that steps up to develop non-invasive for a long time.
Because the glucose in urine positive can only be as the important clue of diagnosing diabetes, can not be as diagnosis basis, even the glucose in urine feminine gender can not be got rid of the possibility of diabetes.So noinvasive and easy glucose in urine detection mode is eliminated gradually.Chinese patent application (application number 99257958) proposition is a kind of directly to detect the method and apparatus of urinating ketone content without reagent paper, obviously is more out of date technology.People turn to saliva to attention again.Chinese patent application (application number 99125993) proposes to detect the equipment of blood glucose in the saliva, the description but how blood glucose sensor works.Chinese patent application (application number 200420063305) has improvement in this respect, proposes with the blood glucose in the optical means detection saliva.Because the blood sugar concentration in the saliva has only 1/50 to 1/100 of blood middle concentration,, be difficult for realizing so this class technology is very high to the requirement of sensor precision.Perspiration also becomes the object that people pay close attention to.The method that Chinese patent application (application number 98111360) early proposes is to extract the perspiration and the tissue fluid on finger surface with a probe that connects air pump, and the reuse glucose oxidase method detects blood sugar concentration wherein.Japan Patent (2,004 003826, Chinese application number 200410081808) proposes a kind of extractor of subcutaneous tissue liquid, and behind the extraction hole extraction secretions that only passes keratodermatitis, the reuse enzyme process detects.The shortcoming one of these class methods is that precision is difficult to guarantee, the 2nd, and complex structure, the problem of also unresolved dependence glucoseoxidase simultaneously.
Remove from urine, saliva, outside trying every possible means on perspiration and the skin histology liquid, many patents have also proposed to utilize various physical chemistry effects directly from the method for skin detection blood glucose.Chinese patent application (application number 03158142) provides a counter ion electric osmose device.By intact skin, the glucose specimen will be collected on the lacquer disk(-sc) this device, measure with very little electric current.The gel dish contains glucoseoxidase, can be hydrogen peroxide with conversion of glucose; The hydrogen peroxide that biosensor assay generates produces the signal of telecommunication, and signal intensity is directly proportional with patient's blood sugar concentration.In fact this method is a kind of technology of covert extraction tissue fluid.Chinese patent application (application number 200410020169) proposes the noninvasive detection device and the detection method thereof of a kind of so-called pulse impedance spectrum blood glucose or other blood constituents, and its checkout gear 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, memory element and communication interface.The frequency sweep constant-current source is provided with pair of exciting, and measuring unit is provided with a pair of measurement electrode, and 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.The basis of the method is to be based upon dynamic pulse wave impedance spectrum and blood glucose has under the assumed conditions of corresponding relation.Yet this relation does not obtain very strict experiment confirm.United States Patent (USP) (application number 60/173,240 and 60/234002, international application no PCT/US2000/035554) adopt the action of a magnetic field in sample (as the blood glucose whole blood), the size that R f signal amplitude reduces from the characteristic frequency can be determined the concentration of analyte (as blood glucose).
From application quantity, adopting the blood glucose in the direct detection of skin capillary tube of the optical means whole blood is the most popular present research direction.Main relevant patent is listed below: Korean Patent (15584/89,11241/90), United States Patent (USP) (08/479,164), United States Patent (USP) (08/634,849), United States Patent (USP) (60/103,883), United States Patent (USP) (60/384,609), United States Patent (USP) (10/372,004), Japan Patent (403518/00), Japan Patent (83587/2002), Chinese patent application (application number 01145153), Chinese patent application (application number 02146704), Chinese patent application (application number 200410034000).The method that this class patent proposes is nothing more than adopting various dissimilar light (as far infrared) irradiation some position of human body (as skin and ear), difference according to blood sugar concentration, difference will appear in its reflected light or transillumination, and reuse opto-electronic conversion and numerical analysis technology are converted to blood glucose concentration value with difference.The problem that these class methods must solve has: the difference of individual patients, the error that the difference at detection position and the difference of skin condition cause; Precision and the reliability measured; The influence that other composition changes in the blood; Detect the processing of data etc.
From business-like angle, the non-invasive blood-sugar detecting instrument that has gone on the market at present also seldom has only the U.S. and Japan to develop the several products that detect blood glucose in perspiration and the skin histology liquid.But the conventional invasive blood sugar instrument that has is seen everywhere.Though so existing numerous noinvasive detects patent, become the product that really satisfies patient's actual demand, have got long long way to go.
Have certain related domestic and international patent to be listed below with the present invention:
United States Patent (USP) (60/103,883, Chinese application number 99813406) proposes a kind of glucose measurement device of non-acupuncture and measures the method for blood sugar concentration in the human body with this measuring device.In this operation, the glucose measurement device is from standardized, reference sample that can be independent.This device utilizes blood sugar concentration to influence the principle of the decay of total reflection infrared spectrum, launches infrared light to tissue (as finger), and compares the feature at the infrared spectrum of two area tests, can measure end user's blood sugar concentration thus.This method faces a lot of difficulties of aforementioned optical means equally, such as the cuticular difference of epiderm skin (thickness, transparency, degree of drying, oils and fats what etc.) cause problems such as detecting data distortion.
The Amada Co., Ltd. Hitachi has proposed a series of patent (2003-195455 that obtain blood glucose by the detection of skin temperature, 2003-178619,2003-129020,2003-338580,2003-331857,2003-349792,2003-404677,2003-331857,2004-040493,2004-052072,2004-055391) these inventions relate under the condition of not carrying out blood sampling the concentration of glucose in the biological living are carried out method for measuring of non-invasion formula and equipment.The blood sugar concentration that the non-intrusion measurement that is undertaken by temperature obtains needs to proofread and correct through blood oxygen saturation and blood flow volume, thereby obtains stable measurement data.This blood sugar level measurement device has comprised three kinds of measuring devices: apparatus for measuring amount of heat is used to measure a plurality of shell temperatures, to obtain to be used for and to calculate from the information of the heat of the heat of the relevant convective heat transfer of the heat of body surface dissipation and transfer of radiant heat; The blood flow volume measurement device is used to obtain the situation of measurement point blood flow; The oxygen saturation measurement device is used to obtain the situation of measurement point blood oxygen content.This method must be considered the various factors that influence the shell temperature measurement accuracy, as ambient temperature, and wind speed, sunlight, clothing, the contact condition of pick off and skin, the influence of the skin thickness even the colour of skin.So the correction of nonoculture blood flow volume and oxygen content is not enough.Can infer, even this equipment is effective, very complicated and expensive, the relation between the various parameters, the problems such as processing of preset function and data are not easy to handle yet yet.
(3) summary of the invention
The purpose of this invention is to provide a kind of non-invasive blood-sugar detecting instrument, solve traditional blood sugar test device structure complexity, the technical problem of certainty of measurement difference.
For achieving the above object, the present invention adopts following technical scheme:
This non-invasive blood-sugar detecting instrument comprises it is characterized in that the movement and the detecting head that is connected with shell of shell 1, enclosure:
The wound that has that operation push-button 7 is arranged on the case surface and be used to demarcate detects blood glucose value enter key 8;
Movement is by the following assembly that connects in turn:
(a), be used for the preamplifier that the faint temperature signal with detecting head input amplifies;
(b), establish the A/D change-over circuit of reference voltage and clock in;
(c), the Single Chip Microcomputer (SCM) system that is used for date processing, this Single Chip Microcomputer (SCM) system contains controller, be used to store and detect data and store trace routine and the memorizer of quantitative relation formula, be used for detecting the computer that data and the relational expression that prestores compare, analyze and handle, above-mentioned quantitative relation formula is from detecting in the more approaching time, adopts standard that the blood glucose value that the wound blood sugar detecting method obtains and the mutual relation formula of variations in temperature characteristic parameter are arranged to same patient;
(d), display;
(e), sound prompting/warning circuit;
(f), switching power supply circuit;
(g), on and off switch and AC Power supply socket;
Detecting head is formed by connecting by the temperature sensor thermometric contact of front end and the earhole adapter 3 at rear portion, earhole adapter 3 combines by the thermistor temperature sensor 3.1 at middle part, the good thermal conductor filler 3.2 that coats with metal sheath 3.3, and thermistor temperature sensor 3.1 is connected with preamplifier in the movement by lead 4 and the change-over circuit that temperature signal is converted to the signal of telecommunication.
Temperature sensor thermometric contact in the above-mentioned detecting head can be thermistor (temperature) sensor, thermocouple sensor, semiconductor PN type pick off, quartz crystal vibration temperature transducer or pyroelectric infrared sensor.
The above-mentioned change-over circuit that temperature signal is converted to the signal of telecommunication can be the Wheatstone bridge change-over circuit.
Above-mentioned detecting head 2 can be connected with heating-cooling unit 5, heating-cooling unit 5 is used for temperature probe is carried out heating and cooling, make it reach default initial temperature, the heating cooling unit can be a semiconductor device, or adds low-temperature receiver or/and external heat source.
Above-mentioned metal sheath can be the paste block formula metal sheath that matches with earhole or oxter.
Aforementioned display device is LCD display or charactron display, and power supply is alternating current power supply or battery.
Also can be equipped with clock, radio and/or chip for cell phone in the above-mentioned movement.
Quantitative relation formula in above-mentioned (c) can be simple coefficient, analytic formula, empirical equation or be stored in curve form among the data base.
It can be the vein whole blood test method or the capillary tube whole blood test method of glucose oxidase method that standard in above-mentioned (c) has the wound blood sugar detecting method.
Can there be the relational expression between ambient temperature and the human body temperature characteristic parameter in the memorizer in above-mentioned (c), be used to import computer, result of calculation is proofreaied and correct.
It is as follows that the Woundless blood sugar that the present invention proposes detects principle:
As everyone knows, body institute energy requirement is to be provided by the sugar in the food more than 70%.The digestion product glucose of sugar can the glycogen form be stored in liver and the muscle.But in the in-vivo tissue glycogen of a lot of cells storages seldom, must rely on frequent from the blood ingestion of glucose to satisfy the needs of metabolism and functional activity.And the glucose in the blood mainly enters these histiocytes by the mode of facilitation diffusion.So the concentration of glucose in the blood maintains certain level, and is significant.Concentration is low excessively, is unfavorable for that glucose diffuses into each histiocyte; Excessive concentration, a large amount of glucose syrups run off with urine by kidney.Liver contains a certain amount of glycogen deposit, keeps dynamic equilibrium with blood sugar content under the adjusting of neuro-humoral mechanism, and on the one hand, the consumption of blood glucose can be replenished from hepatic glycogen; On the other hand, blood sugar concentration increases, and as having absorbed more sugar after the meal, then again at the liver glycogen biosynthesis, stores standby.Wherein, insulin and other hormones have played important function.The blood sugar concentration rising can cause secretion of insulin rapidly.It makes each tissue of whole body quicken picked-up, utilizes and the storage glucose, and the result descends blood glucose concentration.
So, when concentration of glucose in the blood raises, have at least the influencing factor of two aspects to make the body quantity of heat production increase, metabolic rate improves in other words.The one, concentration of glucose raises and makes diffusion process quicken, and histiocyte is easy to obtain glucose, and it utilizes the metabolic process of glucose will speed up, and certainly leads to extra heat, because heat energy is the energy of minimum form.This is that physical action is main factor.The 2nd, the rapid secretion of insulin impels each tissue to quicken picked-up and utilize glucose, and its result can produce extra heat energy equally.This is that biochemical action is main factor.The latter often is counted as the reason that the food specific dynamic effect produces.So-called food specific dynamic effect (spicific dynamic effect), be meant feed after, the body heat production is than the phenomenon of the outer increase of forehead of not taking food.But this effect generally is from taking food back about 1 hour, after can being extended to 7-8 hour.And its heat production is relevant with food species.For mixed food, only additionally increase the heat about 10%.
The experiments of a large amount of accurate designs of inventor show, this extra calorigenic effect is in body and non-uniform Distribution.At some position, as brain and near the ear chamber of head, extra calorigenic effect is obvious more than other positions, and the feed back just begins to manifest in several minutes, and its extra heat production rate can be up to more than 80%.This and cerebral tissue power consumption are far above its hetero-organization, and all the oxidative metabolism from glucose is relevant.At these positions, should be the result of aforementioned two kinds of factor effects, be not general food specific dynamic effect.In other words, even insulin secretion is few or insulin resistant, because the effect of first kind of factor, body still can produce obviously extra heat.Conversely, because brain tissue metabolism mainly relies on the glucose in the blood, in case concentration of glucose is low excessively, facilitation diffusion difficulty, metabolic rate descends, and heat production will reduce.Enter in the blood if can not under the effect of glucagon, allow hepatic glycogen be converted into glucose, will produce stupor even tic.
In sum, the heat production of the height of concentration of glucose by two kinds of mechanism of action and body has positive correlation in the blood.If can with certain constantly the body calorigenic effect accurately measure and standardization, just may obtain the blood glucose value in this moment, if this measuring method is a noinvasive and fast, just can realize the noinvasive fast detecting of blood glucose.
But what of body heat production are not constantly represented this rising or reduction of body temperature constantly.This is because the heat that human body produces, and except by breath, drains and secretions is taken away outside the very little part, mainly contains body surface and diffuses in the external environment.Under general physiological conditions, give birth to thermal velocity and radiating rate basically identical, quantity of heat production is big, and heat radiation is also just big more, otherwise also anti-, makes the body temperature total energy keep constant relatively.Certainly, body temperature has periodic fluctuation in diel.Early morning is minimum during 2-5, and afternoon is the highest during 2-5.But the daily rhythm of body temperature (circadian rhythm) only matches with the earth rotation cycle, and and musculation, noncausal relationships such as oxygen consumption and feed are a kind of intrinsic rhythm and pace of moving things.So the detection by deep body temperature is difficult to the calorigenic effect of body is quantized merely.Consider that shell temperature is subjected to ambient temperature, wind speed, the influence of factors such as dress is very big, if only survey shell temperature, its difficulty will be bigger.Unless detect blood flow and oxygen consumption parameters such as (it are relevant with glucose metabolic rate) simultaneously, as the correction of temperature detection result, just may be near real calorigenic effect.A series of patented technologies of obtaining blood glucose by the detection of skin temperature that this aforementioned just Amada Co., Ltd. Hitachi proposes.Consider the difficulty and the cost of this mode, the present invention takes diverse another kind of technology, to realize identical purpose.
Compared with prior art the present invention has following characteristics and beneficial effect:
The present invention relates to a kind of simple completely newly, reliably and relatively Woundless blood sugar fast detecting equipment.This equipment is tested repeatedly through the inventor, and has carried out a large amount of contrasts with the wound testing result is arranged, and it is fine to coincide.This instrument is based on blood sugar concentration influences the tissue heating, thereby the different principle of detection probe variations in temperature feature that is put in the special position of human body is developed.Experiment shows, if parameter constants such as the shape of detection probe, size, material and thermal capacity, and the initial temperature of ambient temperature and probe is positioned at the certain limit that is lower than body temperature, the climbing speed of blood sugar concentration and probe temperature then, be raised to the required time of a certain temperature from a certain temperature, and the parameters such as maximum temperature that can reach all there is tangible dependency relation.So, can infer the height of blood sugar concentration by detecting these parameters.
Below be to adopt the present invention to carry out the partial results that blood sugar test obtains:
Instrument parameter: power supply 220V/50Hz; Power 5W; Detection range: 3.0-25.0 mmol/L; Detection time＜120s; Resolution 0.1mmol/L; Storage data 30 times; Operative temperature 10-30 ℃; Storage temperature-20-40 ℃; Machine box size: 110 * 70 * 28mm (not containing power supply adaptor); Instruments weight＜0.5kg (not containing power supply adaptor).
Demarcate contrast with there being invasive blood-sugar detecting instrument information as follows:
The full TM vigor of model Luo Kang type (ACCU-CHECK) blood-sugar detecting instrument.Need blood volume 1-2 microlitre, detecting reagent paper is the glucose oxidase enzyme test peper.200 of memory data outputs.The blood glucose unit of display: mmol/L represents with G in the experiment below.
Detected object: Lee XX (type 1 diabetes patient, insulin dependency, women, 73 years old);
Thank to XX (type 2 diabetes mellitus patient, because of drug allergy is not taken medicine, male, 77 years old);
Open XX (type 2 diabetes mellitus patient, clothes biguanides antidiabetic drug, male, 52 years old)
Detection mode: ante cibum is a period of time on an empty stomach and after meal.Detect experimenter's blood glucose simultaneously with non-invasive blood-sugar detecting instrument of the present invention with as demarcating correlated method of cracking:
Lee XX
Noinvasive value detection time (mmol/L) has wound value (mmol/L)
11:05 9.3 9.0
11:20 9.7
11:40 9.3 9.6
11:52 10.2
12:12 8.5 8.0
The 12:15 lunch
12:44 9.7 10.0
12:58 9.8
13:18 10.4 10.1
13:32 10.3
13:48 11.5 11.8
14:04 12.2
14:20 11.6 9.70
14:33 11.0
14:48 11.5 10.0
15:03 10.9
15:18 9.3 9.5
15:33 10.8
15:48 10.3 9.7
16:03 11.5
16:18 11.9 12.2
Thank to XX
Noinvasive value detection time (mmol/L) has wound value (mmol/L)
11:17 17.3 19.0
11:32 16.8
11:47 15.4 14.6
12:02 16.6
The 12:15 lunch
12:37 20.8 20.8
12:58 22.2
13:13 18.5 19.2
13:28 17.9
13:43 19.8
13:58 18.8 20.5
14:13 18.7
14:33 18.9
14:48 22.0 21.5
15:03 19.8
15:18 18.9 20.0
15:33 18.0
15:48 17.9
16:03 20.0 19.4
16:18 19.0
Open XX
Noinvasive value detection time (mmol/L) has wound value (mmol/L)
9:45 5.5 6.0
10:00 5.0
10:20 5.3 5.8
10:40 5.8
11:00 5.2 6.0
11:20 5.9
11:40 5.3 5.5
12:00 5.9
12:08 5.5 5.9
The 12:10 lunch
12:30 9.7 10.0
12:50 9.1
13:10 12.4 13.1
13:30 10.3
13:38 14.5 11.9
13:50 9.9
14:10 9.5
14:30 8.9 9.5
14:50 8.1
15:10 9.0
15:30 8.7 7.9
15:50 8.0
16:10 6.8 5.9
16:30 6.5
16:50 5.6 5.0
From above-mentioned testing result as can be seen, the blood glucose value that obtains with resultant blood glucose level data of non-invasive blood-sugar detecting instrument of the present invention and conventional glucose oxidase method has good dependency.
The non-invasive blood-sugar detecting instrument device that the present invention proposes is compared with existing various blood sugar test technology, has following advance.
1. noinvasive detects, and does not need to extract continually the blood of patient or instrument user, has alleviated misery, the infection risk of having avoided the blood drawing process to bring.
2. do not need easy consumption material or accessory, do not need the glucose oxidase enzyme test peper or the probe that frequently use price high.
3. succinct practical, safety is good, the reliability height.
4. easy to operate, detect fast, cost is lower than other most of testing products.
5. on basis of the present invention, realize the real-time monitoring of blood glucose easily.
(4) description of drawings
The present invention is further detailed explanation below in conjunction with accompanying drawing.
Fig. 1 is the structural representation of the embodiment of the invention one.
Fig. 2 is an electric bridge connection layout used in the embodiment of the invention one.
Fig. 3 is the structural representation of the embodiment of the invention two.
Fig. 4 is the structural representation of the embodiment of the invention three.
Fig. 5 is the structural representation of the paste block temperature probe of the embodiment of the invention three employed monitorings.
Description of drawings: the wound that has that 1-shell, 2-detecting head, 3-earhole adapter, 3.1-thermistor temperature sensor, 3.2-filler, 3.3-metal sheath, 4-lead, 5-heating cooling unit, 6-are used to demarcate detects blood glucose value enter key, 7 operation push-buttons, 8-battery.
(5) specific embodiment
Embodiment one is referring to Fig. 1, and Fig. 1 is a kind of structure principle chart of desk-top non-invasive blood-sugar detecting instrument, and it detects the position is earhole, by an ear temperature detecting head is preheated, and formally detects with another earhole.It comprises the movement and the detecting head that is connected with shell of shell 1, enclosure, it is characterized in that:
The wound that has that operation push-button 7 is arranged on the case surface and be used to demarcate detects blood glucose value enter key 8; The wound detection blood glucose value enter key that has that is used to demarcate has two, indicates arrow up and down respectively.By button, can will have in the wound blood glucose value input instrument, so that demarcate.
Movement is by the following assembly that connects in turn:
(a), be used for the preamplifier that the faint temperature signal with detecting head input amplifies.The effect of preamplifier is that the faint temperature signal that front end is sent into is amplified.Be not subjected to the influence of follow-up circuit in order to ensure the linear compensation feature of signal, output termination one follower at temperature signal will oppositely amplify by the temperature voltage of follower, makes with the raise voltage that successively decreases of temperature to become and increase progressively.Positive linear relationship between formation temperature and the voltage.
(b), establish the A/D change-over circuit of reference voltage and clock in.12 station integrated circuits that adopt MAX1911 are established reference voltage and clock as the A/D change-over circuit in the circuit.A/D conversion is subjected to the control of single-chip microcomputer (central controlled processing unit), and the latter starts the A/D conversion by sheet choosing mouthful and access hole, changes to finish and single-chip microcomputer is read the least-significant byte of translation data and high 4 at twice.Certainly also can adopt other better or relatively poor converter ics.
(c), the Single Chip Microcomputer (SCM) system that is used for date processing, this Single Chip Microcomputer (SCM) system contains controller, be used to store and detect data and store trace routine and the memorizer of quantitative relation formula, be used for detecting the computer that data and the relational expression that prestores compare, analyze and handle, date processing comprises the removal to the temperature invalid data, temperature is advanced the speed, maximum temperature, mean temperature, isoparametric extraction of maximum temperature persistent period and error analysis.
Above-mentioned quantitative relation formula is from detecting in the more approaching time (in as 10 minutes), adopts standard that the blood glucose value that the wound blood sugar detecting method obtains and the mutual relation formula of variations in temperature characteristic parameter are arranged to same patient.Above-mentioned quantitative relation formula can be simple coefficient, analytic formula, empirical equation or be stored in curve form and other similar mathematical relationship among the data base.
It can be the vein whole blood test method or the capillary tube whole blood test method of glucose oxidase method that above-mentioned standard has the wound blood sugar detecting method.Comparing with the blood sugar test standard method that the wound formula is arranged is to be used in synchronization or same basically time period, the blood glucose value that same patient is adopted the vein whole blood test (carrying out in hospital usually) of glucose oxidase method or capillary tube whole blood (be in usually and detected with small-sized blood-sugar detecting instrument by the patient) to detect to obtain is as standard, this standard and the variations in temperature characteristic parameter that obtains are made comparisons, to obtain one or more quantitative relationships.Aforementioned " blood glucose value " that obtains with present technique is meant that the patient in a certain blood capillary full blood glucose value constantly that detects, is unit representation with mmol/L or mg/dL.
Can adopt the 80C31 single-chip microcomputer as the central location that detects control and date processing.Certainly also can adopt other better or relatively poor single-chip microcomputers or integrated circuit and chip.
The basic function of Single Chip Microcomputer (SCM) system is as follows: determine the correct step that temperature voltage is gathered, judge the correctness of initial condition when gathering.Sampled data is added up and calculated.Result of calculation is delivered to display to be shown.Store testing result or connect RAM data storage storage data by interface.Whether timing signal, judgement have the input of wound blood glucose value correct, and calculate automatically at instrument user individual's blood sugar concentration and the quantitative relationship between the temperature profile parameter.Detect Tip Sound or controlling alarm.Key control is preset and pressed to other parameters.
Can also be equipped with clock, radio and/or chip for cell phone in the above-mentioned movement.Realize a tractor serves several purposes, promptly survey blood glucose, time showing, broadcast listening and mobile communication.Make after blood sugar test is finished, be stored in the central die in the past the plurality of detection result in one period, can send to hospital or give the household for reference by cell-phone function.
For further improving the accuracy that detects, can revise the variations in temperature characteristic parameter that obtains by detection to ambient temperature.Promptly by a large amount of experiments, understand the influence of ambient temperature to the blood sugar test accuracy, labor is handled the temperature data that obtains again, sets up relational expression between ambient temperature and the human body temperature characteristic parameter with mathematical statistics method then.In detection after this,, just can under the bigger situation of variation of ambient temperature, also can obtain blood glucose value more accurately by considering this relation.Also can there be the relational expression between ambient temperature and the human body temperature characteristic parameter in the above-mentioned memorizer, be used to import computer, result of calculation is proofreaied and correct.
(d), display.Display can adopt 4 or 4 above high-brightness LEDs, also can adopt cheap charactron.Resolution keeps behind the arithmetic point one at least.Every LED is subjected to a CD4511BCD sign indicating number driver drives, and the P1 mouth of single-chip microcomputer provides data to each driver.
(e), sound prompting/warning circuit.Sound prompting/warning circuit can be formed by buzzer is connected with the INTO mouth of single board computer.When condition is suitable, the buzzer sounding, prompting detects and can begin.Detection is finished or is demarcated when finishing, and prompting can finish.When operate miss or blood glucose severe overweight, can also report to the police automatically.
(f), switching power supply circuit; The switching power supply circuit can directly be bought suitable product and install.Require the dc voltage stability of output good, power is enough to satisfy all component demands.
(g), on and off switch and AC Power supply socket, power supply can be alternating current power supply or battery 8.
Detecting head 2 connects the temperature sensor thermometric contact of front end and the earhole adapter 3 at rear portion, earhole adapter 3 combines by the thermistor temperature sensor 3.1 at middle part, the good thermal conductor filler 3.2 that coats with metal sheath 3.3, and thermistor temperature sensor 3.1 is connected with preamplifier in the movement by lead 4 and the change-over circuit that temperature signal is converted to the signal of telecommunication.
Above-mentioned metal sheath is the paste block formula metal sheath that matches with earhole or oxter.The earhole adapter links to each other with the temperature sensor detecting head, and its shape and size should match with earhole, and its function is to make probe be fixed on certain position in the earhole, guarantees that each condition (probe enters the degree of depth and contact condition) that detects is consistent, to improve detection accuracy.
Above-mentioned detecting head 2 is connected with heating cooling unit 5, can be used for temperature probe is carried out heating and cooling, makes it reach default initial temperature.Heating unit or cooling unit are semiconductor device or add low-temperature receiver or external heat source.The preheating of suitable initial temperature, the pre-cooling mode.Can adopt semiconductor device to come preheating or pre-cooling, also can directly adopt external heat source to do heating in short-term.Also can directly adopt human body that temperature detector is carried out preheating.Such as, earlier temperature detector is put into axillary fossa, treating that its temperature meets the requirements of after the initial temperature putting into earhole carries out official testing.Similarly, an also available earhole preheating is put into the another earhole then and is detected.
Temperature sensor thermometric contact in the above-mentioned detecting head is meant can be by the contact conduction of heat, convection current is or/and the instrument that the correct detected temperatures of radiation mode changes, comprise thermistor (temperature) sensor, thermocouple sensor, semiconductor PN type pick off, quartz crystal vibration temperature transducer or pyroelectric infrared sensor, adopt thermocouple, semiconductor PN, quartz oscillation and mode detected temperatures such as infrared change, and are converted into voltage or current value by modes such as electric bridges again.To its performance demands is that (1) precision is not less than 0.10C.(2) short to the response time of variations in temperature, preferably be not more than 5 seconds.(3) detection probe is to detected temperature field influence as far as possible little (promptly Tan Tou thermal capacity should be the smaller the better).(4) reliable operation, volume with little for well.
Referring to Fig. 2, above-mentioned change-over circuit is that Wheatstone bridge (wheatstone bridge) or non-electric bridge mode connect critesistor, by it temperature signal is converted to the signal of telecommunication.R1 among the figure, R2, R3 are fixed resistance, and Rt is a critesistor, and Vs is an applied voltage, and Vout is an output voltage.If get R1=R2, when R3=Rt, bridge output voltage Vout=0; But when the blood sugar for human body variation causes the earhole gradient of temperature, Rt will be greater than or less than R2, and Vout is with non-vanishing in electric bridge output, so can be for further processing after this output voltage amplification.
Embodiment two, and referring to Fig. 3, what Fig. 3 showed is the non-invasive blood-sugar detecting instrument of another kind of design.It and design difference shown in Figure 1 only are to adopt battery 8 to replace alternating current power supply.Corresponding switching power supply circuit 6 also will be made some and change, to adapt to the characteristics that cell voltage in use constantly descends.Can buy ready-made integrated regulator and assemble, this series products market is on sale.
Embodiment three, and referring to Fig. 4, what Fig. 4 showed is the non-invasive blood-sugar detecting instrument of another design.It and preceding two kinds of differences are that temperature probe is not to heat the initial temperature that reaches required by an ear, but heating-cooling unit in the instrument controls by being located at.14 is heating-cooling units among the figure, and it by regulated power supply 6 power supplies, and utilizes the quasiconductor energising to give birth to heat or cooling by 4 controls of single board computer system.This kind quasiconductor can be bought assembling.
The design of the 4th kind of non-invasive blood-sugar detecting instrument is that with the difference of three kinds of fronts temperature probe makes a kind of paste block form into, is close on the skin at a certain position of health (as the oxter), allows the variations in temperature of one day 24 hours uninterrupted monitoring paste blocks of instrument.This is not to detect body temperature at set intervals one time, but monitors because the heat production that the variation of blood sugar concentration causes changes, and it is reflected in the fluctuating of paster temperature, rather than the fluctuation of body temperature.Such as post-prandial glycemia raises, and quantity of heat production increases, and human body is dispersed unnecessary heat energy by the perspiration mode, to keep constant relatively body temperature.But meanwhile, the unnecessary heat energy that exhales can cause the rising of paste block temperature, and monitoring paste block variation of temperature just can obtain the blood glucose dynamic-change information indirectly.Therefore, this paste block is different with common clinical thermometer, and it should have certain thermal capacitance, and near the shell temperature its variations in temperature and the measured zone is also inconsistent, also asynchronous.In order to detect the temperature of paste block exactly, temperature sensor probe can be placed paste block inside.
Referring to Fig. 5, what Fig. 5 showed is a kind of paste block probe designs scheme.1 is the paste block metal shell among the figure, with copper or aluminium alloy manufacturing.The 3rd, thermistor (temperature) sensor.The 2nd, filler, the resin cast after coagulation good with heat conduction forms.The 4th, lead.In order to monitor conveniently, the instrument of this design preferably uses battery as power supply, and without alternating current.Can pre-determine each blanking time of detecting by the program of input single board computer (central location), also can import by button.Because whole instrument is small and exquisite, can carry.As a kind of optimum organization, can also be with this detector and clock, radio and mobile phone combine.Realize a tractor serves several purposes, promptly survey blood glucose, time showing, broadcast listening and mobile communication.A remarkable advantage of this design is: detect finish after, be stored in the central die in the past the plurality of detection result in one period, all can send to hospital or give the household for reference by cell-phone function easily.
The most of parts that relate in above-mentioned several design can be bought on market or please specialized factory make.So-called central location can be bought common operating mode single-chip microcomputer and finish whole required functions.Such as, adopting model is the single-chip microcomputer of 89S52, its dominant frequency is 24,000,000, can import the control sequence of 8K, and carries the A-D conversion.Temperature detection sensor can directly be bought the temperature detection chip, also can oneself buy the material assembling.Such as, when adopting copper-constantan thermocouple (being easy on market, buy), to amplify earlier from the analogue signal (magnitude of voltage) that the probe that contacts skin spreads out of, carry out the A-D conversion again.No matter, should comprise all and amplifying and the digital translation part that these all are conventional parts, and are readily available as commercial products so adopt where beat temperature detection sensor.As adopt aforementioned 89S52 single-chip microcomputer, then the A-D conversion also can save, because of single-chip microcomputer has carried this function.Same LCDs also can directly be bought from the market.Such as, 128X128 graphic dot matrix Liquid Crystal Module is with Chinese and English character library, can show 8 row Chinese character or English, and built-in T6963C controller is arranged, and carries negative pressure and LED-backlit.The programming that can be provided by aforementioned single-chip microcomputer allows LCDs show required interface (as blood glucose value and detection time) automatically.Also can be) by former blood sugar test data etc.Also can artificially control other function, as access former blood sugar test data etc. by display screen control unit (or button).Default initial temperature selects that multiple mode can be arranged, and the simplest is only to design several preset temperature shelves, as 23 ℃, 28 ℃ and 32 ℃, connects single-chip microcomputer with common Gear-shift switch or band switch and gets final product.Quasiconductor heating-cooling unit can be bought the part self-control, also can ask specialized factory to customize on request, and this series products is very general, and price is not high.Key still need be by suitable programming, realizes preheating accurately-pre-cooling control behind the input single-chip microcomputer.Other part, as on and off switch, protective tube, cabinet, computer interface, socket etc. all are easy to buy the back assembling.Above-mentioned desk-top detector is produced by the inventor, and has carried out a large amount of test experience with it.Effect is fine.
Use Woundless blood sugar detection method of the present invention and comprise following major technique step:
I, selection are applicable to general population's detection position, organ or tissue.
II, at selected detection position, organ or tissue by the investigation to the general population, obtains this position, the mean daily temperature of organ or tissue.
III, determine the default initial temperature of pervasive temperature detector by above-mentioned mean temperature.
IV, according to this initial temperature, design send as an envoy to temperature detector formal detect or monitoring before can reach the technology or the method for this temperature.
V, with having definite material, structure, quality, shape and size, the temperature detector of thermal parameter and initial temperature contacts or near the detection position that chooses, organ or tissue carries out temperature and detects in real time or monitoring.
VI, data or curve that detection is obtained carry out analyzing and processing, find out representative variations in temperature characteristic parameter.
VII, according to the mutual relation of blood glucose value that obtains in advance and variations in temperature characteristic parameter, derive patient or the blood capillary full blood glucose value of instrument user this moment.
Because the difference between the individuality, the quantitative relationship between blood glucose value and the variations in temperature characteristic parameter varies with each individual.So the instrument user need pre-determine this quantitative relationship that is suitable for oneself.This process is called " demarcation ", and its step is as follows.
[1], select the less time period of blood glucose fluctuation, as early morning, at night, ante cibum is on an empty stomach or after 3 hours after meal.
[2], the technical step 1-6 by aforementioned non-wound rapid blood sugar detecting method obtains the variations in temperature characteristic parameter.
[3], simultaneously or almost simultaneously, adopt conventional blood sugar detecting method (glucose oxidase method) to detect the concentration of glucose (generally be to take out a spot of blood capillary earlier, the reuse glucoseoxidase is made specificity analyses) of blood capillary whole blood in temperature detection.
[4], anatomize and handle the various characteristic parameters obtain, find out one or more characteristic parameters that clear and definite coherent relationships is arranged with the concentration value that obtains with glucose oxidase method, set up quantitative relationship between characteristic parameter and the concentration of glucose with mathematical statistics method.
For fast, obtain blood glucose value accurately and reliably easily, the present invention has adopted following measures.
[1], as far as possible select influenced by ambient temperature lessly, easily operation is convenient to thermometric and is applicable to general population's detection position, organ or tissue, and such as earhole, axillary fossa or oral cavity.
[2], select suitable temperature detector initial temperature.Detect for earhole, suitable initial temperature can be at 25-32 ℃, between select.For axillary fossa, suitable temperature range is 20-30 ℃, and for the oral cavity, this scope is 25-35 ℃.
[3], select the suitable preheating that makes temperature detector reach suitable initial temperature, pre-cooling mode.Such as adopting semiconductor device to come preheating or pre-cooling (as the KIT66 type 127P-N statement of account unit of U.S. KITSRUS company, applied voltage 13V, the living heat of forward energising, oppositely energising cooling).Certainly, preheating also can directly adopt external heat source to do heating in short-term merely.Another selection is directly to adopt human body that temperature detector is carried out preheating.Such as, earlier temperature detector is put into axillary fossa, treating that its temperature meets the requirements of after the initial temperature putting into earhole carries out official testing.Similarly, an also available earhole preheating is put into the another earhole then and is detected.
[4], guarantee that as far as possible detection is all carried out at every turn under identical initial condition.These initial condition comprise: same people, same detection position, organ or tissue, same detecting instrument, identical initial temperature etc.
[5], set up the mutual relation between the blood glucose value and variations in temperature characteristic parameter accurately as far as possible.At first to guarantee the quality of the conventional blood sugar test instrument used as standard.Its work should be reliable and stable, and the accuracy of detection height preferably is not less than 0.1mmol/L or 0.1mg/dL; It is less important to carry out two kinds of detection methods under identical condition.These conditions comprise the same tested people and the same detection moment etc.
[6], be further to improve the accuracy that detects, can revise the variations in temperature characteristic parameter that obtains by detection to ambient temperature.Promptly by a large amount of experiments, understand the influence of ambient temperature to the blood sugar test accuracy, labor is handled the temperature data that obtains again, sets up relational expression between ambient temperature and the human body temperature characteristic parameter with mathematical statistics method then.In detection after this,, just can under the bigger situation of variation of ambient temperature, also can obtain blood glucose value more accurately by considering this relation.
Be suitable for the detection mode that the general population uses except above-mentioned, the present invention also proposes the detection mode at concrete patient or the different situations of instrument user, and its main contents comprise:
[1], at the work weather of patient or instrument user, design dissimilar non-invasive blood-sugar detecting instruments.Such as, in office work, fixed work and study environment being arranged for for a long time, live more stabile patient or instrument user can adopt the big slightly desk-top detector of volume.This instrument can adopt indoor alternating current power supply, because volume is unrestricted, device (as ac-dc switching power, preheating, pre-cooling element, temperature probe, control circuit and chip etc.) big choice is arranged, quality can be higher, and accuracy of detection is guaranteed, date processing and memory space are big, energy and computer interface.For for a long time at outside work, working environment mobile big patient or instrument user, can adopt portable, hand-held or Worn type detector.Employing carries dc source, because volume is little, uses more convenient.
[2], at the health of patient or instrument user, determine suitable surveyed area.Such as for the earhole defectiveness, the situation of cicatrix or pathological changes etc. can be selected wrist, zones such as arm or foot.
[3], be further to improve the accuracy that detects, can determine default initial temperature at concrete patient or instrument user.Relatively poor such as circulating slightly for the blood vessel end, the trick temperature is lower patient usually, if surveyed area can suitably reduce presetting initial temperature for the finger end.Passionnate for emotion, shell temperature is higher patient usually, and preset temperature can suitably reduce.
[4], for serious diabetes patient, need one day 24 hours monitoring changes of blood glucose.Can adopt the temperature detector of paste block form, be close on the skin at a certain position of patient body (as the oxter).(as 10 minutes) detect a paste block variation of temperature at set intervals.The initial temperature of paste block is defined as the temperature before each detection.
The present invention adopts one or more definite materials that have, and above-mentioned definite material can be a metal, pottery, plastics or other materials classification.The present invention adopts definite structure, said definite structure can be object with probe side by side, also can be probe in central object in structures such as outer field cylindric or columns.The present invention adopts definite quality, determines shape and size, and the present invention has also adopted the object of definite thermal parameter and definite initial temperature, determines that thermal parameter is meant that this object comprises the overall thermal capacity of probe, parameters such as specific heat and capacity of heat transmission.The initial temperature of determining is meant that this object comprises the bulk temperature of probe before formal detection or monitoring.The contact or near the one or more positions of human body, organ or tissue, human body is meant any zone that has skin in all body surfaces, organ is meant extremity, earhole, oral cavity, body surface or body surface opening organs such as nasal cavity, said tissue is meant outer skin, corium, tissues such as veins beneath the skin.Contact is meant that this object comprises probe and aforementioned position, and organ or tissue closely is close together, and the human body heat production mainly enters this object by the contact conduction pattern.Said " approaching " is meant that this object comprises probe and aforementioned position, and organ or tissue leans on very closely.The human body heat production mainly enters this object by radiation and/or convection type.Detect or monitor at these positions of human body.The situation that this object temperature under organ or tissue's calorigenic action changes.In difference constantly, because the difference of blood sugar concentration, these positions of human body, the heat production rate of organ or tissue or metabolic rate difference, the difference that causes this object temperature to change.Detect or monitor out these variations, temperature data is being carried out on the basis of analyzing and processing, extract one or more characteristic parameters, and have the blood sugar test standard method of wound formula to compare, set up the quantitative relationship between blood glucose value and this object temperature variation characteristic parameter with synchronization.Said " variations in temperature characteristic parameter " is meant and comprises rate temperature change, and a certain period maximum temperature and initial temperature poor arrives parameters such as a certain assigned temperature required time.According to one or more this relations, can derive different human blood glucose concentration values constantly directly by the object temperature variation characteristic parameter that detects or monitoring obtains in the detection afterwards.
Claims (10)
1. non-invasive blood-sugar detecting instrument comprises it is characterized in that the movement and the detecting head that is connected with shell of shell (1), enclosure:
The wound that has that operation push-button (7) is arranged on the case surface and be used to demarcate detects blood glucose value enter key (6);
Movement is by the following assembly that connects in turn:
(a), be used for the preamplifier that the faint temperature signal with detecting head input amplifies;
(b), establish the A/D change-over circuit of reference voltage and clock in;
(c), the Single Chip Microcomputer (SCM) system that is used for date processing, this Single Chip Microcomputer (SCM) system contains controller, be used to store and detect data and store trace routine and the memorizer of quantitative relation formula, be used for detecting the computer that data and the relational expression that prestores compare, analyze and handle, above-mentioned quantitative relation formula is from detecting in the more approaching time, adopts standard that the blood glucose value that the wound blood sugar detecting method obtains and the mutual relation formula of variations in temperature characteristic parameter are arranged to same patient;
(d), display;
(e), sound prompting/warning circuit;
(f), switching power supply circuit;
(g), on and off switch and AC Power supply socket;
Detecting head is formed by connecting by the temperature sensor thermometric contact of front end and the earhole adapter (3) at rear portion, earhole adapter (3) combines by the thermistor temperature sensor (3.1) at middle part, the good thermal conductor filler (3.2) that coats with metal sheath (3.3), and thermistor temperature sensor (3.1) is connected with preamplifier in the movement by lead (4) and the change-over circuit that temperature signal is converted to the signal of telecommunication.
2. according to the non-invasive blood-sugar detecting instrument described in the claim 1, it is characterized in that: the temperature sensor thermometric contact in the above-mentioned detecting head is thermistor (temperature) sensor, thermocouple sensor, semiconductor PN type pick off, quartz crystal vibration temperature transducer or pyroelectric infrared sensor.
3. according to the non-invasive blood-sugar detecting instrument described in the claim 2, it is characterized in that: the above-mentioned change-over circuit that temperature signal is converted to the signal of telecommunication is the Wheatstone bridge change-over circuit.
4. according to the non-invasive blood-sugar detecting instrument described in the claim 3, it is characterized in that: above-mentioned detecting head is connected with heating cooling unit (5), heating-cooling unit (5) is used for temperature probe is carried out heating and cooling, make it reach default initial temperature, heating-cooling unit is a semiconductor device, or adds low-temperature receiver or/and external heat source.
5. according to the non-invasive blood-sugar detecting instrument described in the claim 4, it is characterized in that: above-mentioned metal sheath is the paste block formula metal sheath that matches with earhole or oxter.
6. according to the non-invasive blood-sugar detecting instrument described in the claim 5, it is characterized in that: aforementioned display device is LCD display or charactron display, and power supply is alternating current power supply or battery.
7. non-invasive blood-sugar detecting instrument according to claim 6 is characterized in that: also be equipped with clock, radio and/or chip for cell phone in the above-mentioned movement.
8. non-invasive blood-sugar detecting instrument according to claim 7 is characterized in that: the quantitative relation formula in above-mentioned (c) is simple coefficient, analytic formula, empirical equation or is stored in curve form among the data base.
9. non-invasive blood-sugar detecting instrument according to claim 8 is characterized in that: it is the vein whole blood test method or the capillary tube whole blood test method of glucose oxidase method that the standard in above-mentioned (c) has the wound blood sugar detecting method.
10. non-invasive blood-sugar detecting instrument according to claim 9 is characterized in that: the store memory in above-mentioned (c) has the relational expression between ambient temperature and the human body temperature characteristic parameter, is used to import computer, and result of calculation is proofreaied and correct.
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| DE4342105A1 (en) * | 1993-12-12 | 1995-06-14 | Cho Ok Kyung | Method and device for the non-invasive determination of the concentration of glucose in parts of the human body, in particular in human blood, by performing highly accurate temperature measurements of the human body |
| DE4423663A1 (en) * | 1994-07-06 | 1996-01-11 | Med Science Gmbh | Method and device for detecting thermal interactions between the human body and the device according to the invention and their correlation with the glucose concentration in human blood |
| EP1522254A1 (en) * | 2003-10-08 | 2005-04-13 | Hitachi, Ltd. | Blood sugar level measuring method and apparatus |
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