CN107144697A - Clotting time monitoring device and method - Google Patents
Clotting time monitoring device and method Download PDFInfo
- Publication number
- CN107144697A CN107144697A CN201710340065.4A CN201710340065A CN107144697A CN 107144697 A CN107144697 A CN 107144697A CN 201710340065 A CN201710340065 A CN 201710340065A CN 107144697 A CN107144697 A CN 107144697A
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- microchannel
- pair
- substrate
- clotting time
- monitoring device
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
Abstract
The invention discloses a kind of clotting time monitoring device, it includes substrate and the monitoring terminal located at substrate end, on the substrate microchannel is provided with along zig direction, the top of the microchannel is provided with input port, the end of the microchannel is provided with delivery outlet, position on the microchannel close to input port is provided with a reagent area, plural number is interval with to electrode pair along zig direction on the substrate, two sub- electrodes in electrode pair described in each pair are symmetrically set in microchannel both sides and part and are located in microchannel, wherein, outlet close to the adjacent reagent area of one pair of electrodes of the reagent area is set, electrode pair described in each pair is electrically connected to monitoring terminal by wire and constitutes independent loop.The present invention can conveniently and efficiently measure system administration or the self-management for the clotting time being conducive to helping patient to realize anti-freezing, reduce the incidence of disease of thromboembolism, extend the survival of patients time.
Description
Technical field
The present invention relates to the device and method of measurement gravity flowing medium setting time, more particularly to blood coagulation time
Monitoring device and method.
Background technology
Thrombus is one of important function of blood with hemostasis, and thrombus constitutes presence in blood with the formation and regulation stopped blooding
Complexity, function opposition blood coagulation system and anticoagulation system, they remain dynamic equilibrium by the regulation of various clotting factor,
So that blood maintains normal fluid state under physiological status, both do not spilt over outside blood vessel(Bleeding), and blood is not freezed solidly on
Among pipe(Thrombosis).So, suppress the ability of blood flow after human vas sustains damage to maintaining human body existence pole
To be important.
Blood clot is made up of the platelet plug in insoluble fibrin particle net.Thrombus, which possibly be present at, to follow
Any position in loop system, still, Deep venou is may result in when especially occurring from the lower part of the body, heart, lung or brain
Thrombosis, acute myocardial infarction, pulmonary embolism or acute ischemic stroke, these can all jeopardize the life of people.Therefore, it is accurate
Really monitoring coagulation is necessary, and can reduce the incidence of thromboembolism.
At present, warfarin oral anticoagulation therapy has been widely used, but is due to the limitation of its therapeutic domain, causes
Need frequently to be monitored in therapeutic process, i.e. need to inspect periodically adjustment dosage, to avoid thrombosis and go out
The risk of blood.
Multiple clinical study results confirm that site of deployment is detected immediately(Point-of-care test, POCT)Coagulo meter enters
The advantage of row anti-freezing self-management, it was demonstrated that self detection can avoid adverse reaction.Make Bleeding rate, the thromboembolism morbidity of patient
Rate is substantially reduced, so as to help patient to realize anti-freezing self-management, improve the compliance of patient's anticoagulant therapy, validity and
Security.
A kind of effective solidification measurement is the tissue of so-called prothrombin time (PT) test, measurement blood or blood plasma
Inducible factor setting time, is sensitive for the factor I, II, V, VII and X.
However, the conventional representations of PT test results are unsuitable for international comparison, because these numerical value depend on institute
With the property of factor I.This results in adopt international standards ratio or INR as representing prothrombin time
A kind of form, wherein:
INR=(PT ratio)ISI, wherein ISI is international sensivity index;
And, the averagely normal PT of PT/ of PT ratio=patients.
ISI is according to the World Health Organization using specific factor I relative to factor I
(WHO) derived from the lubber-line of the PT values for multiple samples that international standard reference preparation (Human Combinatorial 67/40) is obtained.Consider special
The particular value for determining the ISI of method and factor I type used is assigned to each PT system, so as to will be each
Individual PT ratios are transformed into standadized ratio.By using INR, patient should be able to keep gratifying solidification level, and this is not
Depending on PT systems used.The then ISI of tissue thromboplastin to be calibrated=known ISI × slope.ISI values are lower, reagent pair
The susceptibility of relevant clotting factor reduction is higher.
There is following defect in the prior art:(1)The method of known current routine in the art needs quiet by human body
Arteries and veins punctures the blood for extracting large volume and precise volumes, then processing blood and needs professional to implement before detect
This method and analysis result, which not only adds the time that the complexity of inspection also expends doctor patient;(2)Used at present
Disposable test bar, its component constitutes complicated various device, measurement electrical conductivity for being unfavorable for convenience, for example, collecting blood sample
Change or measurement viscosity B coefficent device, and the active block that particle is vibrated in electrochemistry contact or detector bar all causes disposable inspection
The production for surveying bar is complicated and expensive, and can not reduce size in the case where not damaging detector bar quality condition;(3)Known detector bar makes
Detection and measuring instrument are still considerably complicated, in some cases, and it needs other devices to transmit or move blood sample
Product, such as magnetic field or pump;In other cases, it needs several detection devices:In the measurement sample for needing calibration detector bar
Some performance changes electrochemistry or magnetic device, and other detection device improves quality control system to read other plates
System, which increase complexity and thereby increases the cost of portable unit.
The content of the invention
The goal of the invention of the present invention is to provide a kind of clotting time monitoring device and method, can conveniently and efficiently measure solidifying
The blood time, simplify Anticoagulation Monitoring step, need to only use human body peripheral blood, reduce Bleeding rate, be conducive to helping patient to realize anti-freezing
System administration or self-management, improve patient's anticoagulant therapy compliance, validity, security, so as to reduce thromboembolism
The incidence of disease of disease, extends the survival of patients time.
To achieve the above object of the invention, the technical solution adopted by the present invention is:A kind of clotting time monitoring device, it includes
Substrate and the monitoring terminal located at substrate end,
A microchannel is provided with along zig direction on the substrate, the top of the microchannel is provided with input port, described micro- logical
The end in road is provided with delivery outlet, the microchannel to be provided with a reagent area, the substrate along substrate close to the position of input port
Length direction is interval with plural number to electrode pair, and two sub- electrodes in electrode pair described in each pair are symmetrically set in microchannel both sides simultaneously
Part is located in microchannel, wherein, the outlet close to the adjacent reagent area of one pair of electrodes of the reagent area is set, described in each pair
Electrode pair is electrically connected to monitoring terminal by wire and constitutes independent loop,
The monitoring terminal is used to record the logarithm of the electrode pair flowed through during blood sample solidification and time used, and counts
Calculate the INR values of blood sample.
Above, the reagent area includes APTT, phosphatide, sodium chloride, calcium chloride, octyl group glucose glucosides, albumen
The reagents such as matter, resin, after blood sample is activated by reagent area, due to the reaction of blood coagulation waterfall, blood sample is within a certain period of time
Viscosity increases and solidified.
Preferably, the substrate is PVC substrates.
Further, the length of the substrate is 80 ~ 250mm.The present invention is not specifically limited to the length of the substrate,
It is typical but non-limiting can be 85mm, 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm, 160mm,
170mm、180mm、190mm、200mm、210mm、220mm、230mm、240mm、245mm.Preferably, length is 150mm.
Further, the substrate is provided with membrane layer, and the membrane layer is provided with the hollow slots along zig direction,
Provided with coating formation microchannel on the membrane layer.
Further, the length of the microchannel is 80 ~ 250mm, and internal diameter is 0.3 ~ 1mm.The present invention is to the microchannel
Length and internal diameter be not specifically limited, it is typical but non-limiting can be length for 85mm, 90mm, 100mm, 110mm,
120mm、130mm、140mm、150mm、160mm、170mm、180mm、190mm、200mm、210mm、220mm、230mm、
240mm、245mm;Internal diameter is 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm.Preferably, length is 150mm, internal diameter
For 0.6mm.
Further, at least 4 pairs electrode pairs are interval with the substrate.
Further, the spacing between two sub-electrodes in electrode pair described in each pair is 0.3 ~ 0.8mm.The present invention is to two
Spacing between individual sub-electrode is not specifically limited, and typical but non-limiting can be 0.4mm, 0.5mm, 0.6mm, 0.7mm.
Preferably, spacing is 0.5mm.
Further, the monitoring terminal includes display module and integrated circuit modules, and the integrated circuit modules include
Counter, timer and data processor.
Preferably, the substrate and monitoring terminal are to be detachably connected.
A kind of clotting time monitoring method, comprises the following steps:
Step 1: taking human body peripheral blood sample;
Step 2: during blood sample is introduced into microchannel from input port, and carry out activation process by reagent area:
Step 3: loop where the blood sample after activation passes through one pair of electrodes, one pair of electrodes is switched on, integrated electricity
Counter and timer on road are started working;
Step 4: blood sample solidification when, the logarithm of the electrode pair for the conducting that data processor is collected according to counter and
The time of last one pair of electrodes of the blood sample that timer is collected from one pair of electrodes to conducting, calculate blood
The INR values of sample, and shown on display module.
Because above-mentioned technical proposal is used, the present invention has following advantages compared with prior art:
1. the present invention on substrate by setting microchannel, spaced electrode pair is set in the both sides of microchannel, blood sample is through examination
Electrode pair is flowed through after the activation of agent area, the loop where each pair electrode pair is turned on, monitoring terminal is solidified by recording blood sample
When the logarithm of electrode pair that is flowed through and time used, calculate the INR values of blood sample, simplify Anticoagulation Monitoring step
Suddenly, be conducive to helping patient to realize system administration or the self-management of anti-freezing, improve the compliance, effectively of patient's anticoagulant therapy
Property, security, so as to reduce the incidence of disease of thromboembolism, extend the survival of patients time;
2. the present invention only need to use human body peripheral blood, Bleeding rate is reduced;
3. the present invention is simple in construction, easy to use, manufacturing cost is low, suitable for popularization and application.
Brief description of the drawings
Fig. 1 is structural representation of the invention in embodiment one.
Wherein:1st, substrate;2nd, monitoring terminal;3rd, microchannel;4th, input port;5th, delivery outlet;6th, reagent area;7th, electrode pair.
Embodiment
Below in conjunction with the accompanying drawings and embodiment the invention will be further described:
Embodiment one:
It is shown in Figure 1, a kind of clotting time monitoring device, it includes substrate 1 and the monitoring terminal 2 located at substrate end,
A microchannel 3 is provided with along zig direction on the substrate, the top of the microchannel is provided with input port 4, described micro-
The position that the end of passage is provided with delivery outlet 5, the microchannel close to input port is provided with edge on a reagent area 6, the substrate
Zig direction is interval with plural number to electrode pair 7, and two sub- electrodes in electrode pair described in each pair are symmetrically set in microchannel
Both sides are simultaneously partly located in microchannel, wherein, the outlet close to the adjacent reagent area of one pair of electrodes of the reagent area is set, often
Monitoring terminal is electrically connected to by wire to the electrode pair and constitutes independent loop,
The monitoring terminal is used to record the logarithm of the electrode pair flowed through during blood sample solidification and time used, and counts
Calculate the INR values of blood sample.
Above, the reagent area includes APTT, phosphatide, sodium chloride, calcium chloride, octyl group glucose glucosides, albumen
The reagents such as matter, resin, after blood sample is activated by reagent area, due to the reaction of blood coagulation waterfall, blood sample is within a certain period of time
Viscosity increases and solidified.
Outlet close to the adjacent reagent area of one pair of electrodes of the reagent area is set, so that blood sample is activated
The loop where this pair of electrode pair can be turned on after processing, starts to be monitored the clotting time of blood sample, therefore, this pair
Electrode pair realizes the automatic monitoring in clotting time equivalent to trigger electrode pair.
The electrode pair and wire are modified on substrate by the method for silk-screen printing, wherein, the sub-electrode of electrode pair
Can be carbon resistance rod or silver electrode.
In the present embodiment, the substrate is PVC substrates.
The length of the substrate is 150mm.
The microchannel is specifically configured to:Membrane layer is provided with the substrate, and the membrane layer is provided with along substrate
The hollow slots of length direction, are provided with coating to form microchannel on the membrane layer.
The length of the microchannel is 150mm, and internal diameter is 0.6mm.
At least 4 pairs electrode pairs are interval with the substrate.
The spacing between two sub-electrodes in electrode pair described in each pair is 0.5mm.
The monitoring terminal includes display module and integrated circuit modules, and the integrated circuit modules include counter, meter
When device and data processor.
The substrate and monitoring terminal is are detachably connected, so that whole device is easy to store and carried.
A kind of clotting time monitoring method, comprises the following steps:
Step 1: taking human body peripheral blood sample;
Step 2: during blood sample is introduced into microchannel from input port, and carry out activation process by reagent area:
Step 3: loop where the blood sample after activation passes through one pair of electrodes, one pair of electrodes is switched on, integrated electricity
Counter and timer on road are started working;
Step 4: blood sample solidification when, the logarithm of the electrode pair for the conducting that data processor is collected according to counter and
The time of last one pair of electrodes of the blood sample that timer is collected from one pair of electrodes to conducting, calculate blood
The INR values of sample, and shown on display module.
Specifically, the logarithm of electrode pair that is flowed through and used when data processor is according to record blood sample solidification
Time Calculation draws the speed of blood sample flowing, then the rate conversion that blood sample is flowed is into INR values.
The foregoing description of the disclosed embodiments, enables professional and technical personnel in the field to realize or using the present invention.
A variety of modifications to above-described embodiment will be apparent for those skilled in the art, as defined herein
General Principle can be realized in other embodiments without departing from the spirit or scope of the present invention.Therefore, it is of the invention
Above-described embodiment shown in this article is not intended to be limited to, and is to fit to and principles disclosed herein and features of novelty phase one
The most wide scope caused.
Claims (10)
1. a kind of clotting time monitoring device, it is characterised in that:It includes substrate and the monitoring terminal located at substrate end,
A microchannel is provided with along zig direction on the substrate, the top of the microchannel is provided with input port, described micro- logical
The end in road is provided with delivery outlet, the microchannel to be provided with a reagent area, the substrate along substrate close to the position of input port
Length direction is interval with plural number to electrode pair, and two sub- electrodes in electrode pair described in each pair are symmetrically set in microchannel both sides simultaneously
Part is located in microchannel, wherein, the outlet close to the adjacent reagent area of one pair of electrodes of the reagent area is set, described in each pair
Electrode pair is electrically connected to monitoring terminal by wire and constitutes independent loop,
The monitoring terminal is used to record the logarithm of the electrode pair flowed through during blood sample solidification and time used, and counts
Calculate the INR values of blood sample.
2. clotting time monitoring device according to claim 1, it is characterised in that:The substrate is PVC substrates.
3. clotting time monitoring device according to claim 1, it is characterised in that:The length of the substrate be 80 ~
250mm。
4. clotting time monitoring device according to claim 1, it is characterised in that:The substrate is provided with membrane layer, institute
Membrane layer is stated provided with the hollow slots along zig direction, provided with coating formation microchannel on the membrane layer.
5. clotting time monitoring device according to claim 1, it is characterised in that:The length of the microchannel be 80 ~
250mm, internal diameter is 0.3 ~ 1mm.
6. clotting time monitoring device according to claim 1, it is characterised in that:At least 4 are interval with the substrate
To electrode pair.
7. clotting time monitoring device according to claim 1, it is characterised in that:Two sons in electrode pair described in each pair
Spacing between electrode is 0.3 ~ 0.8mm.
8. clotting time monitoring device according to claim 1, it is characterised in that:The monitoring terminal includes display module
And integrated circuit modules, the integrated circuit modules include counter, timer and data processor.
9. clotting time monitoring device according to claim 1, it is characterised in that:The substrate and monitoring terminal are removable
Unload connection.
10. a kind of clotting time monitoring method, it is characterised in that comprise the following steps:
Step 1: taking human body peripheral blood sample;
Step 2: during blood sample is introduced into microchannel from input port, and carry out activation process by reagent area:
Step 3: loop where the blood sample after activation passes through one pair of electrodes, one pair of electrodes is switched on, integrated electricity
Counter and timer on road are started working;
Step 4: blood sample solidification when, the logarithm of the electrode pair for the conducting that data processor is collected according to counter and
The time of last one pair of electrodes of the blood sample that timer is collected from one pair of electrodes to conducting, calculate blood
The INR values of sample, and shown on display module.
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CN201710340065.4A CN107144697A (en) | 2017-05-15 | 2017-05-15 | Clotting time monitoring device and method |
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CN201710340065.4A CN107144697A (en) | 2017-05-15 | 2017-05-15 | Clotting time monitoring device and method |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN113702649A (en) * | 2021-08-25 | 2021-11-26 | 常州工程职业技术学院 | Microfluid biochip for measuring blood coagulation time |
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US20040072357A1 (en) * | 2000-12-19 | 2004-04-15 | Matthias Stiene | Device for measuring blood coagulation and method thereof |
CN102818822A (en) * | 2011-06-09 | 2012-12-12 | 五鼎生物技术股份有限公司 | Device and method for measuring prothrombin time and hematocrit (HCT%) by analyzing change in reactance in a sample |
CN103543278A (en) * | 2012-07-16 | 2014-01-29 | 微点生物科技有限公司 | Testing of blood coagulation characteristics |
CN104204787A (en) * | 2012-04-13 | 2014-12-10 | 索尼公司 | Blood coagulation system analyzer, blood coagulation system analysis method and program |
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 |
-
2017
- 2017-05-15 CN CN201710340065.4A patent/CN107144697A/en active Pending
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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US20040072357A1 (en) * | 2000-12-19 | 2004-04-15 | Matthias Stiene | Device for measuring blood coagulation and method thereof |
CN102818822A (en) * | 2011-06-09 | 2012-12-12 | 五鼎生物技术股份有限公司 | Device and method for measuring prothrombin time and hematocrit (HCT%) by analyzing change in reactance in a sample |
CN104204787A (en) * | 2012-04-13 | 2014-12-10 | 索尼公司 | Blood coagulation system analyzer, blood coagulation system analysis method and program |
CN103543278A (en) * | 2012-07-16 | 2014-01-29 | 微点生物科技有限公司 | Testing of blood coagulation characteristics |
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 |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN113702649A (en) * | 2021-08-25 | 2021-11-26 | 常州工程职业技术学院 | Microfluid biochip for measuring blood coagulation time |
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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Application publication date: 20170908 |