A multi-clotting time detection instrument and reagent card

By using a multi-unit coagulation time testing instrument and reagent card, and employing photoelectric sensors and a pump drive module, accurate quantification and mixing of samples are achieved. Combined with a throttle valve and a check valve to prevent sample aspiration into the gas path and waste liquid backflow, this technology solves the problems of inaccurate test results, long testing time, and high cost of multi-unit testing in existing technologies, and realizes rapid and accurate multi-unit coagulation testing.

CN115656489BActive Publication Date: 2026-01-13深圳希克生物医疗科技有限公司
View PDF 7 Cites 0 Cited by

Patent Information

Application Number
CN202211311595.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-10-25
Publication Date
2026-01-13
Estimated Expiration
2042-10-25

AI Technical Summary

Technical Problem

Existing coagulation testing instruments suffer from problems such as insufficient accuracy and reliability of test results, long testing time, susceptibility to interference from abnormal samples, and high cost of multi-sample testing. Furthermore, traditional reagent strips can only test one coagulation item at a time, resulting in inaccurate sample quantification and the problem of sample backflow in the waste liquid channel affecting the test channel.

Method used

The multi-channel coagulation time analyzer consists of an instrument body, a drive module, sensors, and a control processing unit. By setting up multiple test channels and waste liquid channels, it uses photoelectric sensors and a pump drive module to achieve accurate quantification, mixing, and detection of samples. Combined with throttle valves and check valves, it prevents sample aspiration into the gas path and waste liquid backflow, thus realizing multi-channel detection.

Benefits of technology

It enables rapid and accurate detection of multiple coagulation tests, shortens the detection time, improves detection accuracy, prevents excessive or insufficient samples, and ensures the accuracy of test results and the stability of the instrument.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN115656489B_ABST
    Figure CN115656489B_ABST
Patent Text Reader

Abstract

The application discloses a multi-association coagulation time detection instrument and reagent card, and relates to the field of medical devices.The instrument comprises an instrument body, a reagent card channel for reagent card insertion, a first sensor and a second sensor arranged on the instrument body, the first sensor being used for detecting one end of a test channel on the reagent card, and the second sensor being used for detecting a waste liquid channel of the reagent card; a driving module, which is in communication with the waste liquid channel and the test channel respectively; and a control processing unit, which is in signal connection with the driving module, the first sensor and the second sensor respectively.After the above-mentioned instrument is used, a plurality of coagulation items can be tested at a time, each test channel can individually and accurately quantify a sample, and the blood sample and the reagent can be effectively mixed, so that the sample in the test channel can be prevented from being sucked into an air path, the waste liquid sample in the waste liquid channel can be prevented from flowing back, whether the added sample is excessive or insufficient can be detected, and the hematocrit of blood can be accurately detected.
Need to check novelty before this filing date? Find Prior Art

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a multi-union coagulation time detection instrument and reagent card. BACKGROUND

[0002] Coagulation, i.e. blood clotting, refers to the process of blood changing from a flowing liquid state to a non-flowing gel state, which is an important link of physiological hemostasis. The essence of blood clotting is the process of soluble fibrinogen in blood plasma changing into insoluble fibrin.

[0003] When a human body has a wound, blood will automatically clot to avoid massive bleeding. In medicine, the blood clotting ability of the human body has guiding significance for the use of coagulation drugs and anticoagulation drugs. For example, the strength of the blood clotting function of the human body has guiding significance for the amount of heparin used during surgery. Therefore, the examination of the blood clotting mechanism of the human body has a wide demand in the medical field.

[0004] Traditional hospital laboratories usually have the problem of not timely sending coagulation samples for examination or having coagulation sample backlog, so that the test results cannot be returned to the clinic in the first time. The detection turnaround time affects the treatment decision-making time of critically ill patients to some extent. There is a demand for real-time coagulation detection before emergency and outpatient surgery, and there is a demand for intraoperative coagulation monitoring in the operating room. Therefore, a real-time test instrument that can quickly and accurately detect coagulation function is needed.

[0005] The existing real-time test instrument usually uses electrode method or centrifugal disc optical method to detect coagulation function. The detection result of the electrode method is not accurate and reliable. Although the centrifugal disc optical method can realize multi-union detection, it has the problems of complex instrument, long detection time and easy to be interfered by abnormal samples such as hemolysis, jaundice and lipemia. Therefore, how to reduce the coagulation function detection time while improving the detection accuracy and realizing multi-union detection is a problem to be solved in the current coagulation detection instrument industry. SUMMARY

[0006] In view of the above problems of the prior art, the present application aims to provide a multi-union coagulation time detection instrument and reagent card, which can solve the problems of reducing coagulation function detection time, improving detection accuracy and realizing multi-union detection.

[0007] To solve the above technical problems, the first aspect of the embodiment of the present application provides a multi-union coagulation time detection instrument, which comprises:

[0008] An instrument body, wherein a reagent card channel for inserting a reagent card, a first sensor for detecting one end of a test channel on the reagent card, and a second sensor for detecting a waste liquid channel of the reagent card are arranged on the instrument body;

[0009] A driving module, wherein the driving module is respectively connected with the waste liquid channel and the test channel;

[0010] A control processing unit, wherein the control processing unit is respectively connected with the driving module, the first sensor and the second sensor.

[0011] As a further improved technical solution, the driving module is connected with the waste liquid channel and the test channel through an air pipe, wherein a pressure sensor is arranged on the air pipe, and the pressure sensor is connected with the control processing unit.

[0012] As a further improved technical solution, the driving module is a pump driving module, and the pump driving module comprises at least two pumps, and the pumps are arranged on the air pipe.

[0013] As a further improved technical solution, a third sensor is further arranged on the instrument body, wherein the third sensor is used for detecting a sample inlet channel of the reagent card, and the third sensor is connected with the control processing unit.

[0014] As a further improved technical solution, a fourth sensor is further arranged on the instrument body, wherein the fourth sensor is used for detecting the other end of the test channel, and the fourth sensor is connected with the control processing unit.

[0015] As a further improved technical solution, the first sensor, the second sensor and the fourth sensor are all photoelectric sensors, and the third sensor is a photoelectric sensor capable of emitting green light and near-infrared light.

[0016] The second aspect of the embodiment of the present application provides a multi-association coagulation time detection reagent card, wherein the reagent card comprises:

[0017] A sample inlet channel, wherein the sample inlet channel is respectively connected with the waste liquid channel and at least one test channel;

[0018] An air pipe connecting port, wherein the air pipe connecting port is used for connecting with the air pipe, and the air pipe is connected with the waste liquid channel and the test channel.

[0019] As a further improved technical solution, a sample adding port and an overflow hole are further arranged on the reagent card, wherein the overflow hole is located outside the sample adding port, and the sample adding port is connected with the sample inlet channel.

[0020] As a further improved technical solution, the reagent card is provided with at least two throttle valves, one end of the throttle valve is communicated with the tracheal connecting port, the other end of the throttle valve is communicated with the waste liquid channel or the test channel, and a blood clot capturing device is further arranged in the middle of the test channel.

[0021] As a further improved technical solution, a check valve is arranged at one end of the waste liquid channel close to the sample inlet channel, the reagent card comprises a reagent card body, a bottom film and a reagent card label, the bottom film is attached to the lower end face of the reagent card body, the reagent card label is attached to the upper end face of the reagent card body, the bottom film and the reagent card body are attached to form the sample inlet channel, the waste liquid channel and the test channel, and the reagent card label and the reagent card body are attached to form the check valve.

[0022] Beneficial effects: Compared with the prior art, the multi-union coagulation time detection instrument of the present application comprises an instrument body, a first sensor and a second sensor arranged on the instrument body for reagent card insertion, the first sensor is used for detecting one end of the test channel of the reagent card, and the second sensor is used for detecting the waste liquid channel of the reagent card; a driving module which can be respectively communicated with the waste liquid channel and the test channel; and a control processing unit which is signal connected with the driving module, the first sensor and the second sensor, after the above-mentioned instrument is used, a plurality of coagulation items can be tested at one time through the arrangement of a plurality of test channels, each test channel can individually and accurately quantify the sample and effectively mix the blood sample and the reagent, the sample in the test channel can be prevented from being sucked into the gas path through the arrangement of the throttle valve, the waste liquid sample in the waste liquid channel can be prevented from backflowing through the arrangement of the check valve, whether the added sample is excessive or insufficient can be detected, and the hematocrit of the blood can be detected through the arrangement of the third sensor. BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1 is a structural diagram of the multi-union coagulation time detection instrument of the present application.

[0024] Figure 2 is a structural diagram of the reagent card of the present application.

[0025] Figure 3 is a structural diagram of the reagent card of the present application Figure 2 A-A cross-sectional view.

[0026] Figure 4 is a top view of the reagent card of the present application.

[0027] Figure 5 is a bottom view of the reagent card of the present application.

[0028] Figure 6 is a perspective view of the reagent card of the present application.

[0029] Reference signs:

[0030] 1, reagent card; 2, third sensor; 3, second sensor; 4, first sensor; 5, fourth sensor; 6, pressure sensor; 7, air pipe; 8, pump driving module; 9, control processing unit; 10, instrument body; 11, overflow hole; 12, sample adding port; 13, sample inlet channel; 14, check valve; 15, test channel; 16, coagulation blood clot capturing device; 17, waste liquid channel; 18, throttle valve; 19, air pipe connecting port; 20, reagent card label; 21, bottom membrane.

[0031] The implementation, functional features and advantages of the present application will be further described with reference to the embodiments and the accompanying drawings. DETAILED DESCRIPTION

[0032] In order to facilitate the understanding of the present application, the present application will be described more fully below with reference to the accompanying drawings. The preferred embodiments of the present application are shown in the drawings. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present application more thorough and comprehensive.

[0033] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0034] The following disclosure provides many different embodiments, or examples, for implementing different structures of the present application. For the purpose of simplification, the components and arrangements of the specific examples are described in the following disclosure. Of course, they are only examples and are not intended to limit the present application. In addition, the present application can repeatedly refer to reference numerals and / or reference letters in different examples. Such repetition is for the purpose of simplification and clarity, and does not in itself indicate a relationship between the various embodiments and / or arrangements discussed. In addition, the present application provides examples of various specific processes and materials, but those of ordinary skill in the art can realize the application of other processes and / or the use of other materials.

[0035] It should be noted that in the description of the present application, it is necessary to explain that, unless otherwise specified and limited, the terms "mounting", "connection", "connection" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected; it can be directly connected, or indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements. For those of ordinary skill in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0036] The inventors have found that the prior art has the following problems:

[0037] (1) The traditional hospital laboratory usually has the problem of not timely sending coagulation samples for inspection or coagulation sample backlog, so that the test results cannot be returned to the clinic in the first time. The detection turnaround time affects the treatment decision-making time of critically ill patients to some extent. There is a demand for real-time coagulation detection before emergency and outpatient surgery, and there is a demand for intraoperative coagulation monitoring in the operating room, so a real-time testing instrument that can quickly and accurately detect coagulation function in multiple combinations is needed. The existing real-time testing instrument usually uses electrode method or centrifugal disc optical method to detect coagulation function. The electrode method has inaccurate and unreliable detection results. The centrifugal disc optical method can achieve multiple detection, but the instrument is complex, the detection time is long, and it is easily affected by abnormal samples such as hemolysis, jaundice, and lipemia.

[0038] (2) In addition, although the reagent card strip using the coagulation method can solve the problem of reducing the coagulation function detection time, the coagulation method can only detect one coagulation item at a time. The cost of the multiple detection reagent card strip is high, the product process is complex, and the cost of the multiple detection reagent card strip scheme is usually not accurate, the sample backflow affects the test channel, and the sample suction airway of the test channel has problems.

[0039] In order to solve the above problems, the various non-limiting embodiments of the present application will be described in detail below in combination with the drawings.

[0040] As shown in Figure 1 The multi-coagulation time detection instrument provided by the embodiments of the present application comprises:

[0041] An instrument body 10 is provided with a reagent card channel for inserting a reagent card 1, a first sensor 4 and a second sensor 3. The first sensor 4 is used to detect one end of the test channel 15 of the reagent card 1, and the second sensor 3 is used to detect the waste liquid channel 17 of the reagent card 1.

[0042] A driving module can be connected to the waste liquid channel 17 and the test channel 15, respectively.

[0043] A control processing unit 9 is signal connected to the driving module, the first sensor 4 and the second sensor 3, respectively.

[0044] Specifically, the reagent card channel matches the reagent card 1, after the reagent card 1 is inserted into the reagent card channel, the reagent card channel can effectively limit the reagent card 1, the reagent card 1 is provided with at least one test channel 15, each first sensor 4 corresponds to detect a channel, the number of first sensors 4 corresponds to the number of test channels 15, after the reagent card 1 is inserted into the instrument body 10, the first sensor 4 is located above the liquid inlet end of the corresponding test channel 15, the first sensor 4 can detect the blood sample flowing into the test channel 15, in the embodiment, the reagent card 1 is provided with four test channels 15, and the instrument body 10 is also provided with four first sensors 4, and the reagent for testing is pre-embedded in each test channel 15, the reagents in each test channel 15 are different, a plurality of coagulation items can be detected by setting different reagents, the reagent is in a dry powder form, and the reagent can be fully mixed with the blood sample in the test. Similarly, after the reagent card 1 is inserted into the instrument body 10, the second sensor 3 is located above the waste liquid channel 17, the second sensor 3 can detect the liquid flowing into the waste liquid channel 17, the driving module is connected with the waste liquid channel 17 and the test channel 15 respectively after the reagent card 1 is inserted into the instrument body 10, and the driving module is used for driving the liquid flowing in the waste liquid channel 17 and the test channel 15 respectively or simultaneously. The driving module can drive the blood sample to flow back and forth in the test channel 15, so that the reagent can be fully mixed with the blood sample, the control processing unit 9 is signal connected with the driving module, the first sensor 4 and the second sensor 3, and the control processing unit 9 can control the driving module to operate according to the detection signals sent by the first sensor 4 and the second sensor 3.

[0045] Preferably, the driving module is connected with the waste liquid channel 17 and the test channel 15 through the air pipe 7, the air pipe 7 is provided with a pressure sensor 6, the pressure sensor 6 is signal connected with the control processing unit 9, the driving module is a pump driving module 8, and the pump driving module 8 comprises at least two pumps.

[0046] Specifically, in the embodiment, the driving module is a pump driving module 8, the pump driving module 8 includes at least two pumps, the number of the pumps is equal to the number of the test channels 15 plus the number of the waste liquid channels 17, the number of the air tubes 7 is equal to the number of the pumps, the number of the pressure sensors 6 is equal to the number of the air tubes 7, each pump corresponds to one air tube 7, each pump is connected to one air tube 7, each air tube 7 is connected to one corresponding test channel 15 or waste liquid channel 17, and each pressure sensor 6 is connected to one corresponding air tube 7. In the embodiment, the number of the pumps is five, which are a first pump, a second pump, a third pump, a fourth pump and a fifth pump, the number of the air tubes 7 is also five, and the number of the pressure sensors 6 is also five. Among them, four air tubes 7 correspond to one test channel 15 respectively, and the remaining one air tube 7 corresponds to the waste liquid channel 17. The pumping of the pumps controls the liquid flow of the respective corresponding test channel 15 or waste liquid channel 17, the pumping and blowing of the pumps are alternately performed to control the liquid in the respective corresponding test channel 15 to reciprocate in the test channel 15, the pressure sensor 6 can detect the pressure in the air tube 7 and send the detection data to the control processing unit 9, and when the pressure in the air tube 7 changes sharply and is greater than a preset value, it indicates that the blood sample in the test channel 15 coagulates, the coagulated blood sample blocks the test channel 15, so that the pressure in the air tube 7 increases, and the control processing unit 9 can record the coagulation time of the blood sample.

[0047] Preferably, the instrument body 10 is further provided with a third sensor 2, the third sensor 2 is used for detecting the sample inlet channel 13 of the reagent card 1, and the third sensor 2 is in signal connection with the control processing unit 9.

[0048] Specifically, the third sensor 2 is located above the sample inlet channel 13 after the reagent card 1 is inserted into the instrument body 10, the third sensor 2 is used for detecting whether the blood sample has entered the sample inlet channel 13 and flowed from the liquid inlet end to the liquid outlet end of the sample inlet channel 13, and the third sensor 2 can also detect the hematocrit of the blood red blood cells.

[0049] Preferably, the instrument body 10 is further provided with a fourth sensor 5, the fourth sensor 5 is used for detecting the other end of the test channel 15, and the fourth sensor 5 is in signal connection with the control processing unit 9.

[0050] Specifically, after the reagent card 1 is inserted into the instrument body 10, the fourth sensor 5 is located above the corresponding test channel 15, and the fourth sensor 5 is used to detect whether the liquid in the test channel 15 is about to reach the gas outlet end, which is the end away from the liquid inlet end, to play a warning role and prevent the liquid in the test channel 15 from flowing into the air pipe 7. The number of the fourth sensor 5 is consistent with the number of the test channel 15. In this embodiment, the instrument body 10 is provided with four fourth sensors 5, which detect the four test channels 15 respectively. The fourth sensor 5 can send the detection data to the control processing unit 9 for signal processing.

[0051] Preferably, the first sensor 4, the second sensor 3 and the fourth sensor 5 are all photoelectric sensors, and the third sensor 2 is a photoelectric sensor capable of emitting green light and near-infrared light.

[0052] Specifically, in this embodiment, the first sensor 4, the second sensor 3 and the fourth sensor 5 are all photoelectric sensors, specifically infrared sensors, and the third sensor 2 is a photoelectric sensor capable of emitting green light and near-infrared light. The third sensor 2 is composed of two LEDs and one PD. The two LEDs are green light 525 nm and near-infrared light 940 nm LEDs, respectively. Because red blood cells in blood have selective absorption of green light and do not have selective absorption of near-infrared light. Therefore, by measuring the absorption rates of green light and near-infrared light respectively, and taking the absorption rate of the near-infrared band as a reference, the ratio of the absorption rates of green light and near-infrared light can be calculated, so as to exclude interference factors such as physical size and reagent card 1 material, and realize accurate measurement of the hematocrit of the blood to be measured.

[0053] Specifically, the test process is as follows:

[0054] S1, add the sample to be detected to the sample inlet 12. If too much sample is added, the excess sample will overflow from the sample inlet 12 and be received by the sample overflow hole 11 to prevent the sample from contaminating the reagent card 1;

[0055] S2, start the third pump to draw the sample along the sample inlet channel 13 to the third sensor 2;

[0056] S3, start the first pump, the second pump, the fourth pump and the fifth pump to draw the sample along the respective test channels 15 to the first sensor 4 of each channel;

[0057] S4, start the third pump to draw the excess sample along the waste liquid channel 17 until the sample passes the second sensor 3;

[0058] S5, start the first pump, the second pump, the fourth pump, the fifth pump control each test channel 15 sample before the first sensor 4 and the fourth sensor 5 back and forth oscillation, when the sample occurs coagulation, its blood clot will be captured by the blood clot capture device 16, cause this test channel 15 blockage, test channel 15 pressure will occur sharp change, through the pressure sensor 6 connected with this channel detection, thereby accurately recording four test channel 15 sample clotting time;

[0059] S6, when all test channel 15 pressure sensor 6 detects the corresponding channel pressure sharp change, the test is completed.

[0060] Wherein, by the channel length between the first sensor 4 and the sample channel 13, the accurate amount of test channel 15 sample is realized, when the sample oscillates back and forth before the first sensor 4 and the fourth sensor 5, the sample can be effectively mixed with the reagent when passing through the blood clot capture device 16;

[0061] When the fourth sensor 5 fails or for some reason the test channel 15 sample loses control, the sample enters the throttle valve 18, which causes the channel pressure to change sharply, which is much higher than the channel pressure sharp change caused by sample coagulation. By pre-setting the pressure sharp change threshold, this phenomenon can be detected, thereby stopping the test, preventing the blood sample from entering the system air circuit, blocking and polluting the pipeline, and causing the instrument to fail. When the excess sample passes through the sensing area of the second sensor 3 under the action of the third pump, the check valve 14 has a height difference with each channel, which can prevent the excess sample in the waste liquid channel 17 from flowing back to the test channel 15 under the action of capillary force and other external forces, affecting the test process and the accuracy of the results;

[0062] Sample underfill detection: when the first pump, the second pump, the fourth pump, and the fifth pump draw samples along the respective test channels 15 to the sensing area of the first sensor 4, if the sample is insufficient, the sample will leave the sensing area of the third sensor 2, thereby detecting the sample underfill;

[0063] Sample overfill detection: when the third pump draws excess sample along the waste liquid channel 17 until the sample passes through the sensing area of the second sensor 3, if the sample is excessive, it will cause the sample to not leave the sensing area of the second sensor 3 after reaching the set pump stroke and time threshold, thereby detecting the sample overfill.

[0064] Based on the above multi-coagulation time detection instrument, the embodiment provides a multi-coagulation time detection reagent card, the reagent card 1 comprises:

[0065] The sample channel 13 is connected with the waste liquid channel 17 and at least one test channel 15;

[0066] A trachea connecting port 19 is arranged for connecting with the trachea 7, which is communicated with the waste liquid channel 17 and the test channel 15.

[0067] Specifically, the sample inlet channel 13 is a total channel for blood sample inflow, which is communicated with the waste liquid channel 17 and at least one test channel 15. In this embodiment, one waste liquid channel 17 and four test channels 15 are arranged, each test channel 15 can test one blood detection item, and four blood detection items can be tested simultaneously by replacing the reagent embedded in the test channel 15 in advance, which greatly shortens the blood detection time. The positions of the trachea connecting ports 19 correspond to the trachea 7, each trachea connecting port 19 corresponds to one trachea 7, and the number of the trachea connecting ports 19 is equal to the sum of the number of the waste liquid channels 17 and the number of the test channels 15. In this embodiment, five trachea connecting ports 19 are arranged, which correspond to one waste liquid channel 17 and four test channels 15 respectively.

[0068] Preferably, the reagent card 1 is further provided with a sample adding port 12 and an overflow hole 11, the overflow hole 11 is located outside the sample adding port 12, and the sample adding port 12 is communicated with the sample inlet channel 13.

[0069] Specifically, the overflow hole 11 is located outside the sample adding port 12. When adding sample, a pipette or a syringe is used to add sample to the sample adding port 12. When the sample adding port 12 is added with the sample to be detected, if too much sample is added, the excess sample will overflow from the sample adding port 12 and be received by the overflow hole 11 of the sample, so as to prevent the sample from contaminating the reagent card 1.

[0070] Preferably, the reagent card 1 is provided with at least two throttle valves 18, one end of the throttle valve 18 is communicated with the trachea connecting port 19, and the other end of the throttle valve 18 is communicated with the waste liquid channel 17 or the test channel 15. The test channel 15 is further provided with a blood clot capturing device 16 in the middle.

[0071] Specifically, the number of throttle valves 18 is the number of waste liquid channels 17 plus the number of test channels 15. In this embodiment, five throttle valves 18 are provided, which are S-shaped structures. The diameter of the throttle valves 18 is smaller than the diameter of the test channels 15 and the waste liquid channels 17. When the fourth sensor 5 fails or for some reason the sample in the test channel 15 loses control, the sample entering the throttle valve 18 will cause a sharp change in channel pressure. This change is much higher than the sharp change in channel pressure caused by sample coagulation. By pre-setting the pressure steepness threshold, this phenomenon can be detected, thereby stopping the test and preventing the blood sample from entering the system air circuit, blocking and contaminating the pipeline, and causing the instrument to fail. The coagulation blood clot capturing device 16 is composed of a series of staggered column structures. When the sample coagulates, the coagulation blood clot passes through and wraps around the column, thereby being captured by the coagulation blood clot capturing device 16. The column also serves as a stirring function, effectively mixing the blood sample and reagent.

[0072] Preferably, the waste liquid channel 17 is provided with a check valve 14 near one end of the sample inlet channel 13. The reagent card 1 includes a reagent card body, a bottom film 21, and a reagent card label 20. The bottom film 21 is attached to the lower end face of the reagent card body, and the reagent card label 20 is attached to the upper end face of the reagent card body. The bottom film 21 and the reagent card body are attached to form the sample inlet channel 13, the waste liquid channel 17, and the test channel 15. The reagent card label 20 and the reagent card body are attached to form the check valve 14.

[0073] Specifically, the waste liquid channel 17 is provided with a check valve 14 near one end of the sample inlet channel 13. The check valve 14 is a few-shaped structure. When the excess sample passes through the second sensor 3 under the action of the third pump and enters the waste liquid channel 17, the check valve 14 has a height difference between each sample inlet channel 13 and the sample inlet channel 13, which can prevent the excess sample in the waste liquid channel 17 from flowing back to the test channel 15 under the action of capillary force or other external forces, affecting the test process and the accuracy of the test results. The reagent card 1 includes a reagent card body, a bottom film 21, and a reagent card label 20. The reagent card body is provided with recesses of the test channel 15, the waste liquid channel 17, and the sample inlet channel 13. The bottom film 21 is attached to the lower end face of the reagent card body to seal the recesses of the test channel 15, the waste liquid channel 17, and the sample inlet channel 13, thereby forming the sample inlet channel 13, the waste liquid channel 17, and the test channel 15. The reagent card body is provided with a check valve 14 channel. The reagent card label 20 is attached to the upper end face of the reagent card body to seal the check valve 14 channel, thereby forming the check valve 14.

[0074] Compared with the prior art, the multi-coagulation time detection instrument of the application comprises an instrument body 10, a reagent card channel for inserting a reagent card 1, a first sensor 4 for detecting one end of a test channel 15 of the reagent card 1, and a second sensor 3 for detecting a waste liquid channel 17 of the reagent card 1, a driving module, a control processing unit 9, and the like. The driving module can be connected with the waste liquid channel 17 and the test channel 15 respectively. The control processing unit 9 is signal-connected with the driving module, the first sensor 4 and the second sensor 3. After the above instrument is used, a plurality of coagulation items can be tested at one time by setting a plurality of test channels 15. Each test channel 15 can individually and accurately quantify a sample and effectively mix the blood sample and the reagent. The sample in the test channel 15 can be prevented from being sucked into the air path by setting a throttle valve 18. The waste liquid sample in the waste liquid channel 17 can be prevented from flowing back by setting a check valve 14. Whether the added sample is excessive or insufficient can be detected. The hematocrit of blood can be detected by setting a third sensor 2.

[0075] It should be noted that in the description of the present application, it should be understood that the terms "thickness", "upper", "lower", "inner", "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0076] In the description of the present application, the description of the terms "certain embodiments", "one embodiment", "some embodiments", "illustrative embodiments", "example", "specific example", or "some examples" means that the specific features, structures, materials or characteristics described in connection with the embodiments or examples are included in at least one embodiment or example of the present application. In the present specification, the illustrative description of the above terms does not necessarily mean the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0077] Although the embodiments of the present application have been shown and described above, it should be understood that the above embodiments are exemplary and cannot be understood as a limitation on the present application, and those skilled in the art can make changes, modifications, replacements and variations to the above embodiments within the scope of the present application, and the scope of the present application is defined by the claims and their equivalents.

Claims

1. A multiple coagulation time testing instrument for performing coagulation time testing on a reagent card inserted therein, the reagent card comprising: The sample inlet channel, the waste liquid channel and the plurality of test channels are in communication with each other; the gas pipe connection port is used for being connected with a gas pipe, and the gas pipe is in communication with the waste liquid channel and the plurality of test channels; a plurality of throttle valves are arranged on the reagent card, one end of the throttle valve is in communication with the gas pipe connection port, and the other end of the throttle valve is in communication with the waste liquid channel or the plurality of test channels; and a check valve is arranged at one end of the waste liquid channel close to the sample inlet channel. The instrument comprises: The instrument body is provided with a reagent card channel for inserting the reagent card, a first sensor, a second sensor, a third sensor and a fourth sensor; the first sensor is in a plurality of numbers and is arranged for detecting one end of the plurality of test channels of the reagent card, for detecting the sample inflow in the plurality of test channels respectively, and realizing the quantification of the test channel sample through the channel length between the first sensor and the sample inlet channel; the second sensor is arranged for detecting the waste liquid channel of the reagent card, for detecting the sample inflow in the waste liquid channel; the third sensor is arranged for detecting the sample inlet channel of the reagent card, for detecting the sample entering the sample inlet channel and measuring the hematocrit of the sample; and the fourth sensor is in a plurality of numbers and is arranged for detecting the other end of the plurality of test channels respectively, for detecting whether the sample in the test channel reaches the gas outlet end respectively; The driving module comprises a plurality of pumps, and the plurality of pumps are in communication with the waste liquid channel and the plurality of test channels through a gas pipe, and a pressure sensor is arranged on the gas pipe; The control processing unit is signal-connected with the driving module, the pressure sensor, the first sensor, the second sensor, the third sensor and the fourth sensor respectively; the control processing unit controls the work of different pumps through the signals of the pressure sensor, the first sensor, the second sensor, the third sensor and the fourth sensor, and realizes the following detections: When the fourth sensor fails or the test channel sample loses control due to other reasons, the sample entering the throttle valve will cause a sharp change in the channel pressure, which is much higher than the sharp change in the channel pressure caused by the sample solidification, and by pre-setting a pressure sharp change threshold, the phenomenon is detected, and the test is stopped to prevent the blood sample from entering the system gas circuit, blocking and polluting the pipeline and causing the instrument to fail; when the excess sample passes through the sensing area of the second sensor under the action of the pump of the driving module, the check valve has a height difference with each channel, which can prevent the excess sample in the waste liquid channel from flowing back to the test channel under the action of external force and affecting the test process and the accuracy of the test result; Sample underfill detection: if the sample is insufficient during the process that the pump of the driving module extracts the sample along the respective test channels to the first sensor sensing area of each channel, the sample will leave the third sensor sensing area, so that the sample underfill is detected. Sample overloading detection: when the pump of the driving module extracts the excess sample along the waste liquid channel until the sample passes through and leaves the sensing area of the second sensor, if the added sample is excessive, it will cause the sample to not leave the sensing area of the second sensor after reaching the set pump stroke and time threshold, thereby detecting sample overloading.

2. The multiple coagulation time detecting instrument according to claim 1, wherein, The first sensor, the second sensor and the fourth sensor are all photoelectric sensors, and the third sensor is a photoelectric sensor capable of emitting green light and near-infrared light.

3. A multiple coagulation time detection system comprising a reagent card and the multiple coagulation time detection instrument according to claim 1 or 2, wherein the reagent card is applied to the multiple coagulation time detection instrument. The reagent card comprises: a sample inlet channel, a waste liquid channel and a plurality of test channels, the sample inlet channel being in communication with the waste liquid channel and the plurality of test channels respectively; a tracheal connection port for connecting with the trachea, the trachea being in communication with the waste liquid channel and the plurality of test channels; a plurality of throttle valves are provided on the reagent card, one end of the throttle valve being in communication with the tracheal connection port, the other end of the throttle valve being in communication with the waste liquid channel or the plurality of test channels; a check valve is provided at the end of the waste liquid channel close to the sample inlet channel.

4. The multiple coagulation time detection system according to claim 3, wherein The reagent card further comprises a sample inlet and an overflow hole, the overflow hole being located outside the sample inlet, the sample inlet being in communication with the sample inlet channel.

5. The multiple coagulation time detection system according to claim 4, wherein, A blood clot capturing device is further provided in the middle of the test channel.

6. The multiple coagulation time detection system according to claim 5, wherein, The reagent card comprises a reagent card body, a bottom film and a reagent card label, the bottom film being attached to the lower end surface of the reagent card body, the reagent card label being attached to the upper end surface of the reagent card body, the bottom film and the reagent card body being attached to form the sample inlet channel, the waste liquid channel and the test channel, and the reagent card label and the reagent card body being attached to form the check valve.

Citation Information

Patent Citations

  • Cuvette-based apparatus for blood coagulation measurement and testing

    CN102099676A

  • Apparatus and method for platelet function and drug response testing based on microfluidic chip

    CN104903728A

  • Multi-union blood coagulation time detection instrument and reagent card

    CN219039062U

  • Capillary flow device

    US4756884A

  • Blood coagulation time test apparatus and method

    US5302348A