CN105628747B - Clotting time device for testing and analyzing and its method for testing and analyzing - Google Patents
Clotting time device for testing and analyzing and its method for testing and analyzing Download PDFInfo
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- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/02—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance
- G01N27/04—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance
- G01N27/12—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance of a solid body in dependence upon absorption of a fluid; of a solid body in dependence upon reaction with a fluid, for detecting components in the fluid
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Abstract
The present invention relates to a kind of clotting time device for testing and analyzing, it is characterised in that: including testing piece (22), portable main machine；The testing piece (22), which is equipped with, to be accommodated the sample well (1) of blood sample, accommodates the reagent wells (2) of reagent and the capillary channel (3) with conductive layer (5)；The sample well (1), reagent wells (2), capillary channel (3) three are sequentially communicated, testing piece (22) end has stomata (4), allows the liquid to the flowing in capillary channel (3)；The conductive layer (5) connect with electrode interface (7), and the electrode interface (7) accesses the portable main machine；After blood sample is mixed with reagent, mixing liquid is flowed along capillary channel (3), with the flowing of mixing liquid, the resistance of conductive layer (5) generates variation, time needed for portable main machine measures blood coagulation by obtaining the time point of resistance stopping variation.
Description
Technical field
The present invention relates to a kind of clotting time device for testing and analyzing, the especially device of thrombin time test, belong to solidifying
Blood test and analysis technology field.
Background technique
The process abbreviation blood coagulation of blood clotting, is the process that blood is become gel state from flow regime, it is hemostasis function
The important component of energy.Coagulation process is that (academia is commonly called as endogenous a series of process that is deactivated by sequential enzymatic of coagulation factors
Property and exogenous cruor pathway), generate thrombin proteins, promote fibrinogen to form fibrous thrombus grumeleuse.Clinically often
Test method includes activated partial thromboplastin time (APTT) and prothrombin time (PT) and some other parameter
For preventing and curing the illnesss such as thrombus or fibrinolytic.PT is one of blood coagulation routine 4, is mainly used for screening exogenous factor shortage,
With the dosage of monitoring warfarin anticoagulation (Warfarin).Oral warfarin has been widely used in prevention and treatment thrombus
Class illness.Need to be parameter PT regular monitoring and check using the treatment of warfarin patient to ensure at its medication effect
In best dose section.Because of the PT reagent sensitivity and normal value difference of each manufacturer, very big obstacle is caused to the use of PT readings.
International in-vitro diagnosis industry and pathology can establish the standardized PT magnitude method (International of INR thus
Normalized Ratio).As a result, using Warfarin drug patient can INR value in 1.5-3.5 range internal control pharmacy objects
Dosage.Certainly for different illness classes, the zone of reasonableness that medication is monitored with the value of INR is slightly different.To operation patients
Group is INR 2.0-3.5, and is that 1.5-3.0. clinical datas show regular measurement to phlebothrombosis patient's group's INR range
PT can effectively improve medication effect and ensure the safety of antithrombotic reagent dosage.Effective monitoring can lower due to magnificent method
Woods with want it is very few and caused by blood embolization.Drug safety is to be made by not occurring or seldom occurring since warfarin is applied excessively
At bleeding.Dosage easily can be maintained at the suitable range of safety by domestic portable INR monitor, thus
Greatly improve the effect of anticoagulant therapy.
In recent years due to the innovation of science and technology, portable Blood coagulation instrument enters in-vitro diagnosis market, mostly due to it
It is easy to use using small analoids and sensor, and then substantially reduce the time for obtaining patient information.Due to using
INR value Lai Kongyaoge manufacturer result is the same, and the INR portable tester of small-sized simplicity just can be used for Doctor's office or patients home
In.
Thrombus and hemostasis are not only related to preclinical medicine, and with multiple clinical section (such as blood, breathing, digestion, painstaking effort
Pipe, gynaecology, department of general surgery etc.) disease it is closely related.Detection of blood coagulation is one of common inspection project, is such as examined for operation consent
It looks into, inspection item and monitoring clinical oral administration anticoagulant patient, prediction thrombosis, disseminated intravascular coagulation examine before thrombus
The diagnosis of disconnected, the congenital or deficiency of coagulation factors day after tomorrow, Index for diagnosis of liver diseases etc..Four inspections of blood coagulation therein are more normal
With before performing an operation in hospital such as patient, doctor always may require that patient takes blood to do Coagulation mechanism inspection, and examining for blood coagulation four includes blood coagulation
Zymogen time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), it is therefore an objective to
The hemostatic function for understanding patient in the preoperative has zero defect, to do some preparations in advance, prevents big bleeding in art and is caught unprepared.
In the prior art for the detection in clotting time, using the optical characteristics (light transmission of detection blood plasma and reagent mixture
Degree) variation method, or using magnetic force property variation method, and be based on these method testing analysis instruments, on
It is insufficient for the detection method visual in clotting time to state two kinds, and detection device is more complicated, detection device value is high
High, testing cost is higher, while the precision monitored is also usually since equipment or the factor of environment are not so good as people's will.
Summary of the invention
The purpose of the present invention is to provide a kind of completely new blood coagulation device for testing and analyzing, improve the intuitive of clotting time detection
Degree, while the conditions requirements such as detection required equipment, environment are reduced, keep clotting time detection more convenient, convenient in clinic
It uses with the following small medical unit in county, while being used convenient for being gradually generalized in patients home.It is believed that this is populous, extensively
The China of the shortage of the high tip Medical Instruments in large village and Podunk, the execution to surgical operation, and the treatment to phlebothrombosis,
And the lifelong patient using warfarin, it will be a big Gospel.
The present invention takes following technical scheme:
A kind of clotting time device for testing and analyzing, including testing piece 22, portable main machine；The testing piece 22, which is equipped with, to be held
Receive blood plasma sample well 1, accommodate reagent reagent wells 2 and capillary channel 3 with conductive layer 5；The sample well 1, reagent wells
2,3 three of capillary channel is sequentially communicated, and 22 end of testing piece has stomata 4, allows the liquid to flow in capillary channel 3
It is dynamic；The conductive layer 5 is connect with electrode interface 7, and the electrode interface 7 accesses the portable main machine；When blood sample and reagent are mixed
After conjunction, mixing liquid is flowed along capillary channel 3, and with the flowing of mixing liquid, the resistance of conductive layer 5 generates variation, portable
Time needed for host measures blood coagulation by obtaining the time point of resistance stopping variation.
The technical program is ingenious in design, and conduction can both be caused by being flowed in capillary by blood and reagent mixed liquor body
The resistance variations of layer, so that obtaining resistance automatically by test macro stops the time point of variation to measure the clotting time, and same
When due to be detection resistance variation, test macro software and hardware is relatively easy, and cost is greatly reduced, and use portable survey
Test piece greatly improves the portable degree of a whole set of test device, is conducive to the more universal wider progress under various medical environments
It promotes.
Further, the testing piece 22 is transparent material, can intuitively observe mixing liquid in capillary most
Stop the position of flowing eventually, to see the length of clotting time and bleeding time, intuitively convenient for comparison.
Further, one layer of conductivity silk of the uniform coating in the inside of the capillary channel 3, for conduction, the conductance silk
It is plated in the two sides of the y direction bottom surface of capillary channel.
Further, the testing piece 22 is in rectangular slat shape, and the electrode interface 7 is set to the one of the testing piece 22
End, the sample well 1, reagent wells 2 are set to the other end, the tortuous middle part that testing piece 22 is arranged in of capillary channel 3.
Further, the setting that the capillary channel 3 spirals is in testing piece 22, to reduce the volume of testing piece, improves
Portability.
Further, the portable main machine is equipped with for prompting operating procedure and/or showing the liquid crystal of test data
Display screen 12, the data external connection interface 14 for data output.
Further, the portable main machine changes according to the end point values and combined impedance of capillary miniflow with Coagulation test
Performance graph, calculate the end point values of clotting time and bleeding time, performance graph contains the blood coagulation overall process of whole blood sample, and then is used for
The measurement of other coagulation parameters.
Further, the miniflow that Quality Control capillary channel 6 is also set up in testing piece 22 as auxiliary compares pipeline, auxiliary
Miniflow comparison pipeline can provide double circuit collector compared with positive value, wherein without reagent miniflow comparison pipeline different blood can be provided
Sample is because of viscosity, erythrocyte sedimentation rate, current difference caused by blood cell concentration difference, to weigh on the non-coagulation parameters influence between blood sample
Renormalization.
Further, testing piece 22 by egative film 10 and upper piece form, both for hydrophilic plastic film, and intermediate
It is that by egative film and upper piece bonding, to form capillary channel closed circuit by one layer of adhesive film 9.
The beneficial effects of the present invention are:
1) ingenious in design.
2) visual of measurement result is substantially improved.
3) requirement of test equipment is greatly reduced, reduces testing cost and threshold, convenient for below clinic and county
Small medical unit uses, while using convenient for being gradually generalized in patients home.
4) clotting time test process is more convenient.
5) test equipment is more small and exquisite, more portable.
6) believe, this is in populous, the China of the shortage of the high tip Medical Instruments of vast rural area and Podunk, to surgery
The execution of operation, and the treatment to phlebothrombosis, and will be a big Gospel using the lifelong patient of warfarin.
7) present invention is the performance graph changed according to the end point values and combined impedance of capillary miniflow with Coagulation test, meter
Calculate the end point values in clotting time.Performance graph contains the blood coagulation overall process and traditional full-automatic optical method of whole blood sample
Analysis method it is identical, thus accuracy is high.
8) relative to the real impedance method of existing products in markets, the absolute value variation of impedance is only surveyed, the whole blood of people is in blood coagulation
It is varied less in journey.And impedance silk used in analoids of the present invention joined one high conductance substance for the impedance of blood sample,
To be exaggerated to impedance method, high sensitivity is in traditional electrode method.In addition, the miniflow comparison pipeline of auxiliary can provide again
Double circuit collector compared with positive value.Wherein the comparison pipeline without reagent can provide different blood samples because of viscosity, erythrocyte sedimentation rate, blood cell concentration difference
Current difference caused by different, to influence to carry out weight normalization to the non-coagulation parameters between blood sample.
Detailed description of the invention
Fig. 1 is the structural schematic diagram using a kind of testing piece of clotting time device for testing and analyzing of the invention.
Fig. 2 is the longitudinal section that testing piece is located at sample well and reagent wells position.
Fig. 3 is the longitudinal section that testing piece is located at capillary channel position.
Fig. 4 is the schematic diagram using a kind of portable test host of clotting time device for testing and analyzing of the invention.
In figure, 1. sample wells, 2. reagent wells, 3. capillary channels, 4. groups of stomatas, 5. conductive layers, 6. Quality Control capillary channels, 7.
Electrode interface, 8. printing conductance silks；11. test equipment shell, 12. liquid crystal displays, 13. external power supply sockets, outside 14. data
Connecting port, 15. "upper" function menu selection keies, 16. "lower" function menu selection keies, 17. Menu key, 18. on & off switches, 19. really
Determine key, 20. mark power supply status and warm-up mode, 21. heating sheets, 22. testing pieces.
Specific embodiment
Present invention will be further explained below with reference to the attached drawings and specific examples.
The principle of the present invention is the whole blood (including blood cell, blood platelet and blood plasma) according to human body, can be a kind of special one
Flowing in the capillary channel of secondary property testing piece.It is solidified under the action of blood drying Activated Coagulation agent prefabricated in testing piece, when
When blood clotting process is completed, capillary miniflow can stop.When the time that blood starts to touch the stopping of blood miniflow with reagent is blood coagulation
Between.It is coated with conductive filament in capillary channel and changes with time for measuring impedance of the fluid via microchannel when.And then root
It changes with time according to impedance and is accurately determined clotting time and bleeding time.This is obtained by tracking the time graph of impedance variations.
Use PT reagent as activator, make blood sample coagulation, and then normalizes the PT value measured with the ISI calibration value according to agents useful for same
For the INR value for monitoring warfarin dosage.It is unstable since whole blood impedance is big, the impedance readings error in capillary stream
Can be very big, and change in impedance value is too small, and the present invention is using capillary flow as dynamic basis, in addition impedance silk is as substrate, then
Amplify impedance contrast with micro- bridge method, to reach the sensitivity and accuracy of signal.
Referring to Fig. 1-Fig. 2, following all diagrams are intended merely to illustrate a part in many designs of the present invention, not
Mean to limit the scope of application of the invention.
One portable blood coagulation measuring and analysing meter especially takes warfarin and carries out oral resist to the whole blood to patient
The patient of solidifying drug therapy is monitored.Fig. 1 shows the design of a testing piece in preferred embodiment, wherein 22 be test
The main body of piece is made by hydrophilic plastic material, is used to comprising a sample well 1 plus human whole blood sample, a reagent wells 2 are used
Come place test PT reagent, a capillary channel 3 so that sample due to capillary phenomenon flow ipe, a Quality Control capillary
Road 6 does normalization to sample or is used as the instant Quality Control of liquid, and one group of printing conductance silk 8 is completed to tested blood sample and quality-control sample
Electrical measurement, one group of stomata 4 are to cause liquid inflow pipe for forming capillarity, and electrode interface 7 is inserted by four needles
Card is connected to system hardware.The testing piece pipeline of one typically preferred embodiment is as shown in Figure 2.This is a testing piece 22
Longitudinal section perspective view, including using virtual extension of the section tangent line to capillary channel part.22 in Fig. 2 be the master of testing piece
Body, sample well 1 are placed in the starting point of the testing piece of elongated shape, and the bottom of testing piece be then capillary channel and with sample well
Bottom is connected, and reagent wells 2 are directly connected with sample well by capillary channel.Capillary miniflow in capillary channel 3 is by being located at
Caused by the stomata 4 of testing piece end, blood sample can be made to flow by capillary channel.A pair of of conductance silk is by digital printing
Method is plated in the both ends of capillary channel horizontal direction, electrically insulated from one another, to cause two when blood flows through capillary channel respectively
It is closed circuit that the connection of side conductance silk forms resistance wire, and then collects electric signal in electrode interface 7.Fig. 3 is testing piece capillary
The cross section of road part.As shown in figure 3, the entirety of testing piece is made of three layers of hydrophilic plastic material, wherein testing piece master
Body 22 by egative film 10 and upper piece form, both for hydrophilic plastic film, and centre is by one layer of adhesive film 9 by egative film
Form capillary channel with upper piece bonding closed circuit.In Fig. 3, that a pair of of conductance silk is plated in the y direction of capillary channel, is scheming
In be identified as part 5.
Fig. 4 is the schematic diagram of the present invention most preferably instrument of one of example.It in this case, include the outer of a machine
Shell 11, a liquid crystal display 12 shows test result as to user, and can carry out according to the prompt of display screen
Simple instrument behaviour does option.In figure 13 be external power supply socket, 14 be that data external connection interface can be used for being connected to user
Optional computer or concatenation printer, " menu " key 17 are used to open and close the machine operation " menu " on display screen, 15 Hes
16 keys for respectively representing "up" and "down" are used to selecting the option of menu, the switch of machine by 18 " ON/OFF " key controls,
" OK " key 19 is for receiving option or continuing to operate in next step, and indicator light 20 identifies power supply status and warm-up mode, heating sheet
21 it is beneath be equipped with a constant temperature controller circuit be used to heat and keep testing piece stablize in the temperature pre-set, once
The testing piece that property uses is shown as 22 in figure, sample well 1.
Our uses of impedance silk use screen printing silver method plating graphite powder thin layer on 3M egative film.Its advantages are structures
Good, coating is stablized, and conducts electricity very well, is easy to do large-scale processing.
Host circuit board includes following part: 1) acquiring the detecting head of data, mainly include clock (oscillator), resistance is read
It takes；2) digital-to-analogue conversion；3) power supply；4) subtract noise control；5) memory software package；6) figure processing and conversion software；7) it shows
Display screen；8) operation key；9) printer (user's option).
The present invention is the performance graph changed according to the end point values and combined impedance of capillary miniflow with Coagulation test, is calculated
The end point values of clotting time and bleeding time.Performance graph contains the blood coagulation overall process and traditional full-automatic optical method of whole blood sample
Analysis method is identical, thus accuracy is high.Relative to the real impedance method of existing products in markets, the absolute value variation of impedance is only surveyed,
The whole blood of people varies less in coagulation process.And impedance silk used in analoids of the present invention joined the impedance of blood sample
One high conductance substance, to be exaggerated to impedance method, high sensitivity is in traditional electrode method.In addition, the miniflow of auxiliary
Comparison pipeline can provide again double circuit collector compared with positive value.Wherein the comparison pipeline without reagent can provide different blood samples because viscous
It spends, erythrocyte sedimentation rate, current difference caused by blood cell concentration difference, to influence to carry out weight normalizing to the non-coagulation parameters between blood sample
Change.
Claims (9)
1. a kind of clotting time device for testing and analyzing, it is characterised in that:
Including testing piece (22), portable main machine；
The testing piece (22), which is equipped with, to be accommodated the sample well (1) of blood sample, accommodates the reagent wells (2) of reagent and with conductive layer
(5) capillary channel (3)；
The sample well (1), reagent wells (2), capillary channel (3) three are sequentially communicated, and testing piece (22) end has gas
Hole (4) allows the liquid to the flowing in capillary channel (3)；
The conductive layer (5) connect with electrode interface (7), and the electrode interface (7) accesses the portable main machine；
After blood sample is mixed with reagent, mixing liquid is flowed along capillary channel (3), with the flowing of mixing liquid, conductive layer (5)
Resistance generate variation, portable main machine stops the time point of variation by obtaining resistance come the time needed for measuring blood coagulation；
The testing piece (22) is transparent material.
2. clotting time device for testing and analyzing as described in claim 1, it is characterised in that: the inside of the capillary channel (3)
One layer of conductance silk of uniform coating, for conduction, the conductance silk is plated in the two sides of the y direction bottom surface of capillary channel.
3. clotting time device for testing and analyzing as described in claim 1, it is characterised in that: the testing piece (22) is long in rectangle
Strip, the electrode interface (7) are set to the one end of the testing piece (22), the sample well (1), reagent wells (2) setting
In the other end, middle part of the tortuous setting of capillary channel (3) in testing piece (22).
4. clotting time device for testing and analyzing as described in claim 1, it is characterised in that: what the capillary channel (3) was spiraled
It is arranged on testing piece (22), to reduce the volume of testing piece, improves portability.
5. clotting time device for testing and analyzing as described in claim 1, it is characterised in that: the portable main machine is equipped with and is used for
It prompts operating procedure and/or shows the liquid crystal display (12) of test data, the data external connection interface (14) for data output.
6. clotting time device for testing and analyzing as described in claim 1, it is characterised in that: the portable main machine is according to capillary
The performance graph that the end point values and combined impedance of miniflow change with Coagulation test, calculates the end point values of clotting time and bleeding time, dynamic
Curve contains the blood coagulation overall process of whole blood sample, and then is used for the measurement of other coagulation parameters.
7. clotting time device for testing and analyzing as described in claim 1, it is characterised in that: also set up matter on testing piece (22)
Hair control thin pipe (6) compares pipeline as the miniflow of auxiliary, and the miniflow comparison pipeline of auxiliary can provide double circuit collector
Compared with positive value, wherein the miniflow comparison pipeline without reagent can provide different blood samples because of viscosity, erythrocyte sedimentation rate, caused by blood cell concentration difference
Current difference, to influence to carry out weight normalization to the non-coagulation parameters between blood sample.
8. clotting time device for testing and analyzing as described in claim 1, it is characterised in that: testing piece (22) is by egative film (10)
It is formed with upper piece, both for hydrophilic plastic film, and centre is to be made egative film and upper piece bonding by one layer of adhesive film (9)
Capillary channel forms closed circuit.
9. a kind of method that clotting time test analysis is carried out using clotting time device for testing and analyzing described in claim 1,
It is characterized by:
After blood sample is mixed with reagent, mixing liquid is flowed to capillary channel (3), with the flowing of mixing liquid, conductive layer (5)
Resistance generate variation, stop the time point of variation by obtaining resistance come the time needed for measuring blood coagulation；
Intuitively observe that mixing liquid is finally stopped flowing in capillary by the testing piece (22) of transparent insulation material
Position, to intuitively see the length of clotting time and bleeding time.
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| US20180015455A1 (en) * | 2016-07-12 | 2018-01-18 | Emulate Inc. | Additive channels |
| CN109100394B (en) * | 2018-07-18 | 2020-10-02 | 浙江大学 | A kind of coagulation time detector and its detection method |
| CN110057890B (en) * | 2019-03-26 | 2021-07-30 | 中国科学院苏州生物医学工程技术研究所 | A blood coagulation detection chip and electrochemical sensor |
| CN110596239A (en) * | 2019-10-22 | 2019-12-20 | 世纪亿康（天津）医疗科技发展有限公司 | Blood coagulation function detection device and method |
| CN113702649B (en) * | 2021-08-25 | 2022-09-02 | 常州工程职业技术学院 | Microfluid biochip for measuring blood coagulation time |
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| US4849340A (en) * | 1987-04-03 | 1989-07-18 | Cardiovascular Diagnostics, Inc. | Reaction system element and method for performing prothrombin time assay |
| US5302348A (en) * | 1992-12-10 | 1994-04-12 | Itc Corporation | Blood coagulation time test apparatus and method |
| US5504011A (en) * | 1994-10-21 | 1996-04-02 | International Technidyne Corporation | Portable test apparatus and associated method of performing a blood coagulation test |
| US5908786A (en) * | 1997-12-12 | 1999-06-01 | Akzo Nobel, N.V. | Blood coagulation monitoring device with liquid crystal and gradient heater |
| GB0030929D0 (en) * | 2000-12-19 | 2001-01-31 | Inverness Medical Ltd | Analyte measurement |
| US7837941B2 (en) * | 2006-04-07 | 2010-11-23 | Agamatrix, Inc. | Method and apparatus for monitoring alteration of flow characteristics in a liquid sample |
| US7674616B2 (en) * | 2006-09-14 | 2010-03-09 | Hemosense, Inc. | Device and method for measuring properties of a sample |
| MX2009013093A (en) * | 2007-06-20 | 2010-05-17 | Mec Dynamics Corp | Methods and apparatus for measuring blood coagulation. |
| CN103383391B (en) * | 2012-05-04 | 2015-07-08 | 北京尚位非凡医药科技有限公司 | Detection apparatus for blood clotting time |
| US9291612B2 (en) * | 2012-07-16 | 2016-03-22 | Micropoint Bioscience, Inc. | Determining blood coagulation characteristics using residual accumulative conductive energy |
| US20150140671A1 (en) * | 2013-11-18 | 2015-05-21 | Johnson Electric S.A. | Method and system for assembling a microfluidic sensor |
| CN205449864U (en) * | 2015-12-18 | 2016-08-10 | 上海奥普生物医药有限公司 | Clotting time test analytical equipment |
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Address after: 201201 Shanghai City, Pudong New Area Ruiqinglu No. 526 Patentee after: Shanghai Aopu biomedical Co., Ltd Address before: 201201 Shanghai City, Pudong New Area Ruiqinglu No. 526 Patentee before: Shanghai Upper Bio-tech Pharma Co., Ltd. |