CN117030796A - A CGM electrode detection tool and its detection method - Google Patents
A CGM electrode detection tool and its detection method Download PDFInfo
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- CN117030796A CN117030796A CN202310799532.5A CN202310799532A CN117030796A CN 117030796 A CN117030796 A CN 117030796A CN 202310799532 A CN202310799532 A CN 202310799532A CN 117030796 A CN117030796 A CN 117030796A
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Abstract
本发明属于CGM电极的检测技术领域，具体涉及一种CGM电极检测工装及其检测方法，所述工装包括供液组件，驱动试剂瓶内的测试液由输送管道流经测试组件的检测板；测试组件，驱动待测电极浸入检测板内流动的测试液中，电路板收集待测电极的反应电流传输至数据处理组件；温度反馈控制组件，包括第一温度传感器和第三温度传感器，第一温度传感器随着待测电极一同移动至流动的测试液中，实时检测测试液温度；第三温度传感器设置在加热基板上，并连接温度控制器，温度控制器控制加热基板加热溶液槽内的测试液使其达到设定的温度。本发明在检测CGM电极的过程中，检测液始终是流动状态，更加贴合人体的组织液环境，提高检测结果的准确度。
The invention belongs to the field of CGM electrode detection technology, and specifically relates to a CGM electrode detection tooling and a detection method thereof. The tooling includes a liquid supply component that drives the test liquid in the reagent bottle to flow through the detection plate of the test component through a transport pipe; The component drives the electrode to be measured to be immersed in the test liquid flowing in the detection plate, and the circuit board collects the reaction current of the electrode to be measured and transmits it to the data processing component; the temperature feedback control component includes a first temperature sensor and a third temperature sensor. The first temperature sensor The sensor moves into the flowing test solution together with the electrode to be measured, and detects the temperature of the test solution in real time; the third temperature sensor is set on the heating substrate and connected to a temperature controller, which controls the heating substrate to heat the test solution in the solution tank. Let it reach the set temperature. During the process of detecting the CGM electrode of the present invention, the detection liquid is always in a flowing state, which is more suitable for the tissue fluid environment of the human body and improves the accuracy of the detection results.
Description
Technical Field
The invention belongs to the technical field of detection of CGM electrodes, and particularly relates to a CGM electrode detection tool and a detection method thereof.
Background
Currently, there are two main ways of self blood glucose monitoring for diabetics, the traditional blood test (Blood Glucose Monitoring, BGM) and continuous blood glucose monitoring (Continuous Glucose Monitoring, CGM). BGM mainly uses traditional glucometer, uses most mature and popular, but has more pain points, and continuous blood sugar monitoring can detect blood sugar level of patients in real time, has the ability of finding hidden hyperglycemia and hypoglycemia which are not easy to detect by traditional detection methods, and becomes a new trend of blood sugar monitoring.
The continuous blood glucose monitor includes sensor, also called CGM electrode, and the CGM electrode is implanted into the skin to monitor blood glucose, and the subcutaneous CGM electrode contains glucose oxidase to react chemically with the glucose in subcutaneous tissue to produce electric signal, which is transmitted to analysis software via emitter and converted into blood glucose value via data processing. Because the CGM electrode needs to be put into a human body, the service period is as long as 7-14 days, the requirements of sensitivity, repetition precision and the like of the CGM electrode are higher, and the performance detection of the CGM electrode is necessary before formal use.
In the prior art, when testing CGM electrodes, test solution in a beaker or other vessels is formed by mixing PBS buffer solution (phosphate buffer salt solution) and glucose solution with a certain concentration, a rotor is required to be placed in the vessel in the test process, the vessel is placed on a stirring table, the solution in the vessel is uniformly stirred for testing through rotation of the rotor, and the rotor cannot stop rotating in the test process because of rotation of the rotor, the depth of the traditional solution vessel is higher, the occupied space is larger, the required test solution amount is more, and the cost is higher.
Meanwhile, the detection solution is stored in a non-flowing vessel, and the fixed volume of the detection solution has certain volatilization loss in the long-time detection process, and particularly the volatilization of the solution is more serious under the heating condition, so that the height of the detection solution can be reduced, the test depth of the electrode to be detected can be changed, and the detection accuracy is reduced. Along with the extension of the test time, the amount of glucose required to react with enzyme is gradually reduced, and the accuracy of the detection data has a certain deviation.
In addition, in the actual working environment of the CGM electrode, the tissue fluid of the human body continuously flows, and at present, most of detection tools of the CGM electrode usually have a static state of the test fluid, and the test fluid is inconsistent with the tissue fluid environment flowing in the human body, so that the detection environment is deviated from the actual working environment, and the detection result of the electrode is distorted.
Disclosure of Invention
In order to solve the technical problems in the prior art, the invention provides the CGM electrode detection tool and the detection method thereof, which can effectively simulate the tissue fluid environment flowing in a human body and improve the detection accuracy.
In order to achieve the above purpose, the technical scheme of the invention is as follows:
CGM electrode detects frock includes:
the liquid supply assembly drives the test liquid in the reagent bottle to flow through the detection plate of the test assembly through the conveying pipeline by the first peristaltic pump;
the testing component is used for driving the electrode to be tested to be immersed in the testing liquid flowing in the detection plate, and the circuit board is connected with the electrode to be tested and used for collecting the reaction current of the electrode to be tested and transmitting the reaction current to the data processing component;
the temperature feedback control assembly comprises a third temperature sensor and first temperature sensors corresponding to the number of the electrodes to be detected, wherein the first temperature sensors move to flowing test liquid along with the electrodes to be detected, the first temperature sensors detect the temperature of the test liquid in real time, the third temperature sensors are arranged on the heating substrate, the signal output ends of the third temperature sensors are connected with a temperature controller, and the temperature controller is connected with and controls the test liquid in the heating substrate heating solution tank to reach a set temperature.
Further, the liquid supply assembly comprises a reagent bottle, a liquid inlet rotary valve and a liquid inlet peristaltic pump, wherein a liquid outlet pipe and a liquid inlet pipe are inserted into the reagent bottle, the liquid outlet pipe is connected with a liquid inlet of the liquid inlet rotary valve, a liquid outlet of the liquid inlet rotary valve is connected with a conveying pipeline, and the conveying pipeline penetrates through the liquid inlet peristaltic pump to be connected with a liquid inlet end of the detection plate.
Further, the liquid supply assembly further comprises a liquid outlet rotary valve and a liquid outlet peristaltic pump, the liquid outlet end of the detection plate penetrates through the liquid outlet peristaltic pump through a conveying pipeline to be connected with a liquid inlet of the liquid outlet rotary valve, and a liquid outlet of the liquid outlet rotary valve is connected with a reagent bottle.
Still further, the number of the reagent bottles is not less than two, and the reagent bottles are provided in the heating device.
Further, the test assembly comprises a detection plate, a driving unit and a mounting unit; the electrode to be measured is fixed on the mounting unit, the driving unit comprises a Y-axis moving part and a Z-axis moving part, the Y-axis moving part drives the circuit board to move towards one side of the electrode to be measured and contact with the electrode to be measured to realize signal conduction, and the Z-axis moving part drives the mounting unit, the electrode to be measured and the Y-axis moving part to move downwards together so that the electrode to be measured is immersed in flowing test liquid.
Further, the Y-axis moving part comprises a transverse plate, and the transverse plate is fixed on the Y-axis base plate; the Y-axis motor is arranged on the transverse plate, vertical plates are arranged on two sides of the transverse plate, guide rails are arranged on the upper surfaces of the vertical plates, the upper parts of the guide rails are connected with an upper supporting plate in a sliding mode through sliding blocks, and the Y-axis motor drives the upper supporting plate to horizontally reciprocate through a screw rod mechanism; the upper supporting plate is connected with the bottom plate through vertical plates arranged at two ends, the bottom plate is fixedly connected with the compression driving block, and a circuit board is arranged on the side wall of the compression driving block opposite to the mounting unit.
Furthermore, the circuit board is provided with an elastic contact point, and the electrode to be tested is provided with a contact point which is contacted with and conducted with a signal point of the circuit board.
Still further, the electrode that awaits measuring is the electrode slice that connects gradually through the substrate, the electrode slice includes test portion and substrate, test portion protrusion substrate sets up, the fixed part is cut out at the electrode slice both ends, run through on the fixed part and set up the fixed orifices, the electrode slice passes through the fixed orifices block on the installation cell.
Furthermore, the electrode to be tested is a single electrode cut from the base material, and the electrode is clamped on the mounting unit through the fixing hole which is formed in a penetrating manner.
Furthermore, the mounting unit comprises a fixing plate and a connecting plate, wherein the rear end face of the fixing plate is provided with a sliding rail, and the front end face of the fixing plate is provided with a fixing groove for clamping an electrode to be tested; the fixed slot is provided with a fixed bulge corresponding to the electrode to be detected, the sliding rail is in sliding connection with the connecting plate through a sliding groove, the side wall of the fixed plate is also provided with a limiting rod in a protruding mode, the connecting plate is provided with a limiting slot corresponding to the limiting rod, the limiting rod horizontally penetrates through the limiting slot of the connecting plate, and the connecting plate is fixed on the Y-axis moving part.
Further, the detection plate is fixed through a bracket, and a heating substrate is arranged between the lower end face of the detection plate and the bracket.
Still further, the up end of pick-up board is concave to set up a plurality of solution grooves that take the structure of convex in cross-section, the one end intercommunication feed liquor end in solution groove, the other end intercommunication play liquid end in solution groove, be close to the feed liquor end in the solution groove and set up two or more mixing boards, a plurality of through-holes are run through to the level on the mixing board, and adjacent two the through-hole between the mixing board is crisscross setting.
Still further, the testing plate top sets up the apron, set up first opening and the second opening that corresponds with solution groove position on the apron, first opening and second opening are used for passing electrode and first temperature sensor that awaits measuring respectively.
The invention also provides a CGM electrode detection method, which is applied to the CGM electrode detection tool and comprises the following steps:
s1, preparing electrodes to be tested, namely directly cutting out a plurality of electrodes or a single electrode from an electrode preparation substrate, and mounting the electrodes or the single electrode on a test assembly;
s2, simulating human body environment, applying power by a peristaltic pump, and enabling test liquid in the reagent bottle to flow through the solution tank at the speed of flowing human tissue liquid;
s3, collecting test data, conducting electric signals by the circuit board and the contact to be detected, keeping the electrode to be detected immersed in the flowing test liquid for a plurality of days, reacting the electrode to be detected with glucose in the test liquid to generate a current signal, and continuously feeding the current signal back to the data processing component;
s4, standard data are collected, and the glucose content in the test liquid is detected through a standard electrode at intervals and is used as standard data to be recorded;
s5, data processing, namely comparing the test data with the standard data, and judging whether the electrode to be tested meets the standard.
Further, the simulation of the human body environment also comprises,
s21, simulating blood sugar changes, configuring test solutions with different concentrations in a plurality of reagent bottles, and selecting the test solution in the corresponding reagent bottle according to different test environments;
s22, simulating temperature change of tissue fluid, preheating and heating the test fluid, preheating the test fluid in the reagent bottle by using a heating device, and heating the test fluid in the solution tank by using a heating substrate, so that the temperature of the test fluid tested by the electrode to be tested is set.
Further, in the step S3, after the liquid level of the test solution in the solution tank tends to be stable horizontally, the depth of the electrode to be tested immersed in the test solution is 5-7mm.
Compared with the prior art, the invention has the following beneficial effects:
according to the CGM electrode detection tool provided by the invention, the reflux channel is formed through the liquid supply component, so that the test liquid is always in a flowing state in the process of detecting the CGM electrode, the reduction of the volatilization volume of the test liquid in the test process can be avoided, the stable test depth of the electrode to be detected is ensured, meanwhile, the test liquid continuously flows for updating, the glucose content in the test liquid is relatively stable, and the detection accuracy is improved.
According to the CGM electrode detection tool provided by the invention, the liquid supply assembly and the temperature feedback control assembly are matched, so that the test liquid can simulate the flow of the tissue liquid and approach the temperature of the tissue liquid, the actual working environment of the CGM electrode can be more attached, and the accuracy of the CGM electrode detection can be improved.
According to the invention, the mixing plate is arranged in the solution tank, so that the concentration of the detection liquid in the liquid is more uniform through the mixing plate, and the detection error is reduced.
According to the invention, a plurality of solution tanks are arranged on one detection plate, so that detection of a plurality of electrodes can be performed at one time, and the detection efficiency is improved; meanwhile, through the design of the inlet and the outlet of the solution tank, the concentration and the capacity in each solution tank are the same, and the detection error is further reduced.
According to the invention, the corresponding Y-axis moving part is arranged, so that the PCB circuit board and the electrode can be separated, the electrode can be conveniently replaced, the equipment utilization rate and the detection efficiency are improved, and in addition, the influence of oxidase caused by early electrifying of the electrode is avoided, and the detection result is further influenced.
Drawings
Fig. 1 is a schematic diagram of the structure of the present invention, in which the pipe for detecting the flow of the liquid is not shown.
Fig. 2 is a partial enlarged view of fig. 1 at a.
Fig. 3 is a schematic view of the mounting structure of the detection plate.
Fig. 4 is a schematic structural view of the detection plate.
FIG. 5 is a schematic view of another angle of the detecting plate.
FIG. 6 is a schematic diagram of the structure of the test assembly.
Fig. 7 is a right side view of the test assembly.
Fig. 8 is a schematic structural view of the Y-axis moving member.
Fig. 9 is a schematic diagram of a relative position structure of the circuit board and the electrode to be tested.
Fig. 10 is a schematic view of the mounting structure of the electrode to be tested.
Fig. 11 is a schematic structural diagram of a plurality of electrodes to be tested.
Fig. 12 is a schematic diagram of the structure of a single electrode under test.
Reference numerals illustrate:
1-a base, 2-a heating device, 3-Z axis moving parts, 301-an electrode to be tested, 302-Z axis motors,
4-detecting plate, 401-solution tank, 402-liquid inlet end, 403-liquid outlet end,
5-reagent bottles, 6-liquid inlet rotary valves, 601-first liquid inlets, 602-first liquid outlets, 7-liquid outlet rotary valves, 701-second liquid outlets, 702-second liquid inlets, 8-liquid inlet peristaltic pumps, 9-liquid outlet peristaltic pumps, 10-first mixing plates, 11-second mixing plates, 12-cover plates, 13-brackets, 14-heating substrates,
15-Y axis moving parts, 1501-cross plates, 1502-Y axis motors, 1503-risers, 1504-guideways, 1505-sliders, 1506-upper support plates, 1507-base plates,
the device comprises a 16-Y-axis base plate, a 17-connecting plate, a 18-fixing plate, a 19-compression driving block, a 20-circuit board, a 21-sliding rail, a 22-sliding groove, a 23-first temperature sensor, a 24-second temperature sensor, a 25-data processing assembly and a 26-sensor bracket.
Detailed Description
The technical solutions of the present invention will be clearly described below with reference to the accompanying drawings, and it is obvious that the described embodiments are not all embodiments of the present invention, and all other embodiments obtained by a person skilled in the art without making any inventive effort are within the scope of protection of the present invention.
It should be noted that the relative arrangement of the components and steps, numerical expressions and numerical values set forth in these embodiments should not be construed as limiting the scope of the present invention unless it is specifically stated otherwise. Furthermore, it should be understood that the dimensions of the various elements shown in the figures are not necessarily drawn to actual scale, e.g., the thickness, width, length, or distance of some elements may be exaggerated relative to other structures for ease of description.
The following description of the exemplary embodiment(s) is merely illustrative, and is in no way intended to limit the invention, its application, or uses. Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail herein, but where applicable, should be considered part of the present specification.
Example 1
As shown in fig. 1, the embodiment provides a CGM electrode detection tool, which comprises a liquid supply assembly, a test assembly and a temperature feedback control assembly.
The liquid supply assembly drives the test liquid in the reagent bottle 5 to flow through the detection plate 4 of the test assembly through the conveying pipeline by the liquid inlet peristaltic pump 8.
As shown in fig. 1 and 2, the liquid supply assembly includes a reagent bottle 5, a liquid inlet rotary valve 6 and a liquid inlet peristaltic pump 8, the liquid inlet rotary valve 6 has a first liquid inlet 601 and a first liquid outlet 602, a liquid outlet pipe and a liquid inlet pipe are inserted on the reagent bottle 5, the liquid outlet pipe is connected with the first liquid inlet 601 of the liquid inlet rotary valve 6, the first liquid outlet 602 of the liquid inlet rotary valve 6 is connected with a conveying pipeline, and the conveying pipeline passes through the liquid inlet peristaltic pump 8 and is connected with the liquid inlet end 402 of the detection plate 4.
As shown in fig. 1 and 2, the liquid supply assembly further includes a liquid outlet rotary valve 7 and a liquid outlet peristaltic pump 9, the liquid outlet rotary valve 7 has a second liquid inlet 702 and a second liquid outlet 701, the liquid outlet end 403 of the detection plate 4 passes through the liquid outlet peristaltic pump 9 through a conveying pipeline and is connected with the second liquid inlet 702 of the liquid outlet rotary valve 7, and the second liquid outlet 701 of the liquid outlet rotary valve 7 is connected with a liquid inlet pipe of the reagent bottle 5.
In this embodiment, the number of the reagent bottles 5 is not less than two, and the reagent bottles 5 are all arranged in the heating device 2 for preheating, the heating device 2 can adopt a water bath, and test liquids with different concentrations are contained in different reagent bottles 5 for detecting parameter indexes in different environments, and each time one reagent bottle 5 is detected, the first liquid inlet 601 is corresponding to one reagent bottle 5; during detection, according to the reagent bottle 5, the reagent bottle is switched to the corresponding first liquid inlet 601, the test liquid enters the liquid inlet rotary valve 6 from the first liquid inlet 601, then flows out from the first liquid outlet 602, and the first liquid outlet 602 is a common liquid outlet. The test liquid flowing out from the first liquid outlet 602 flows into the solution tank 401 through a pipeline for detection. The test liquid flows into the second liquid inlet 702 from the solution tank 401, the second liquid inlet 702 is a common liquid inlet, the test liquid enters the liquid outlet rotary valve 7 from the second liquid inlet 702, flows out from the corresponding second liquid outlet 701 and flows back into the reagent bottle 5, so that the test liquid is in a flowing state continuously in the detection process, the test liquid is more close to the tissue liquid environment in the human body, and the accuracy of the detection result is improved.
As shown in fig. 1, the test assembly drives the electrode to be tested to move downwards to be immersed in the flowing test liquid, and the circuit board is connected with the electrode to be tested and collects the reaction current of the electrode to be tested and transmits the reaction current to the data processing assembly.
As shown in fig. 6, the test assembly includes a detection plate 4, a driving unit and a mounting unit, the electrode 301 to be tested is fixed on a fixing plate 18 of the mounting unit, the driving unit includes a Y-axis moving part 15 and a Z-axis moving part 3, the Y-axis moving part 15 drives a circuit board 20 to move to the side of the electrode 301 to be tested and contact to realize signal conduction, and the Z-axis moving part 3 drives the mounting unit, the electrode 301 to be tested and the Y-axis moving part 15 to move downward together to immerse the electrode 301 to be tested in the flowing test liquid.
As shown in fig. 11, the electrodes 301 to be tested are electrode plates sequentially connected through a substrate, each electrode on the electrode plate is provided with a contact point contacting with a signal point of the circuit board, a test part of the electrode plate protrudes out of the substrate, two ends of the electrode plate are cut out to form fixing parts (two end structures shown in fig. 11), fixing holes are formed in the fixing parts in a penetrating manner, the electrode plate is clamped with the fixing plate 18 through the fixing holes, and the fixing plate 18 is detachably connected to the mounting unit.
As shown in fig. 12, the electrode 301 to be measured may also be a single electrode cut from a substrate, the electrode is clamped on the fixing plate 18 through a fixing hole formed therethrough, and the fixing plate 18 is detachably connected to the mounting unit.
As shown in fig. 9 and 10, the mounting unit includes a fixing plate 18 and a connecting plate 17, the rear end surface of the fixing plate 18 is provided with a sliding rail 21, the front end surface is provided with a fixing groove for clamping the electrode 301 to be tested, the sliding rail 21 is slidably connected with the connecting plate 17 through a sliding groove 22, and guiding and limiting effects are provided for mounting the fixing plate 18. And the side wall of the fixed plate 18 is also provided with a limiting rod in a protruding way, the limiting rod horizontally penetrates through the limiting slot hole of the connecting plate 17, and the connecting plate 17 is fixed on the Y-axis moving part 15. The fixing groove is provided with a fixing protrusion corresponding to the position of the electrode 301 to be measured, and in the installation process, the fixing hole of the electrode 301 to be measured is aligned with and clamped with the positioning protrusion on the fixing plate 18, so that the electrode 301 to be measured is fixed in the fixing groove on the front end surface of the fixing plate 18. Then, the sliding rail 21 of the fixed plate 18 is opened from one side of the sliding groove 22 of the connecting plate 17 and slides into the sliding groove 22, and the limiting rod on the side wall of the fixed plate 18 firstly passes through the limiting slot hole on one side of the sliding groove 22 to limit the fixed plate 18; until the assembly is completed, the fixing plate 18 is detachably arranged on the connecting plate 17, and the fixing plate 18 is detachably connected with the connecting plate 17, so that replacement of the electrode to be tested is facilitated, and the operation efficiency is improved.
As shown in fig. 6, 7 and 8, the Y-axis moving member 15 includes a cross plate 1501, and the cross plate 1501 is fixed to the Y-axis base 16; the Y-axis motor 1502 is arranged on the transverse plate 1501, the vertical plates 1503 are arranged on two sides of the transverse plate 1501, the guide rails 1504 are arranged on the upper surfaces of the vertical plates 1503, the upper parts of the guide rails 1504 are connected with the upper support plate 1506 in a sliding mode through the sliding blocks 1505, and the Y-axis motor 1502 drives the upper support plate 1506 to horizontally reciprocate through a screw mechanism. The upper support plate 1506 is connected with the bottom plate 1507 through vertical plates arranged at two ends, the fixed connection on the bottom plate 1507 compresses tightly the drive block 19, the side wall opposite to the installation unit of the drive block 19 is provided with the circuit board 20, the drive block 19 drives the circuit board 20 to be close to or far away from the electrode 301 to be tested, and when the circuit board 20 compresses tightly the electrode 301 to be tested, the electrode 301 to be tested is conducted, and signal acquisition and transmission can be achieved.
The Y-axis moving part 15 realizes signal connection of the electrode 301 to be tested, first, the Y-axis motor 1502 drives the upper support plate 1506 to move towards one side of the electrode 301 to be tested through the screw mechanism, the pressing driving block 19 moves along with the bottom plate 1507, the circuit board 20 on the pressing driving block 19 approaches to the electrode 301 to be tested in the moving process, the elastic contact points on the circuit board 20 are in contact connection with the signal points on the electrode 301 to be tested, each electrode 301 to be tested corresponds to a group of elastic contact points and an independent signal transmission line, and the current signal on the electrode 301 to be tested in the testing process is transmitted to the data processing assembly 25 through the signal transmission line.
The Z-axis motion assembly 3 comprises a Z-axis motor 302, and the Z-axis motor 302 drives the electrode 301 to be tested to be inserted into the solution tank 401; the electrode 301 to be tested realizes up-and-down reciprocating motion through the Z-axis moving part 3, the electrode 301 to be tested can be inserted into the detection liquid for detection when moving downwards, and the electrode 301 to be tested can be far away from the detection liquid when moving upwards. The Z-axis motor 302 drives the Y-axis substrate 16 to reciprocate up and down through a screw mechanism; the Y-axis baseplate 16 is provided with a Y-axis moving part 15 and a connecting plate 17, one side of the connecting plate 17 is provided with a compression driving block 19, and the Y-axis moving part 15 drives the compression driving block 19 to horizontally reciprocate.
As shown in fig. 4 and 5, a plurality of solution tanks 401 with circular arc-shaped cross sections are concavely arranged on the upper end surface of the detection plate 4, a plurality of solution tanks 401 are arranged in an equidistant array, and electrodes 301 to be detected are arranged in one-to-one correspondence with the solution tanks 401. The resistance of the flowing of the detection liquid is reduced by the solution tank with the circular arc structure, so that the flowing of the detection liquid is more stable.
One end of the solution tank 401 is communicated with the liquid inlet conveying pipeline through a liquid inlet end 402, the other end is communicated with the liquid outlet conveying pipeline through a liquid outlet end 403, at least two mixing plates are vertically arranged in the solution tank 401 near the liquid inlet end 402, a plurality of through holes are horizontally formed in the mixing plates, and the through holes between two adjacent mixing plates are staggered. In this embodiment, the detection liquid flows through the first mixing plate 10 first, then flows through the second mixing plate 11, and the concentration in the detection liquid is more uniform under the action of the two mixing plates, and the electrode 301 to be detected is used for detecting the mixed detection liquid, so as to improve the detection accuracy.
In the prior art, the CGM electrode needs to continuously detect for 7-14 days in the actual working process, but in the prior art, substances in the solution are settled along with the test, so that the upper layer concentration and the lower layer concentration of the test solution are inconsistent, and the CGM electrode can only test the concentration of the upper layer solution in the test groove, thereby causing the deviation of the test result. Therefore, in this embodiment, at least two mixing plates are disposed in the solution tank 401, and through holes on the mixing plates are disposed in a staggered manner, so as to avoid sedimentation of substances when the detection solution flows in the solution tank, and realize uniform mixing of substances in the detection solution.
The apron 12 is set up to pick-up plate 4 top, and apron 12 covers all solution grooves 401 to set up the first opening that supplies electrode 301 to be measured to pass and the second opening that supplies temperature sensor to pass on the apron 12, apron 12 can reduce the volatilization of detection liquid effectively, and guarantees the cleanliness factor of detection solution.
As shown in fig. 1, the temperature feedback control assembly includes first temperature sensors 23 corresponding to the number of the electrodes to be measured, the first temperature sensors 23 are disposed on one side of the electrodes to be measured 301 and move into the flowing test liquid along with the electrodes to be measured, the first temperature sensors 23 detect the temperature of the test liquid in real time, the third temperature sensors are disposed on the heating substrate 14, the signal output ends of the third temperature sensors are connected to a temperature controller, and the temperature controller is connected to and controls the heating substrate to heat the test liquid in the solution tank to reach a set temperature.
As shown in fig. 3, the detection plate 4 is fixed by the bracket 13, and a heating substrate 14 is provided between the lower end surface of the detection plate 4 and the bracket 13, and the detection liquid can be heated by the heating substrate 14, so that the detection liquid environments at different temperatures can be simulated. The temperature feedback control assembly further comprises a data processing assembly 25 and a second temperature sensor 24 arranged in the heating device 2, wherein the data processing assembly 25 is electrically connected with the first temperature sensor 23, the second temperature sensor 24, the third temperature sensor and the circuit board 20.
In the detection process, the water bath temperature in the heating device 2 is detected by the second temperature sensor 24, so that the detection liquid reaches the set preheating temperature, and when the water bath temperature detected by the second temperature sensor 24 is lower than the set preheating temperature, the temperature setting of the heating device is increased, and the water in the heating device 2 is heated until the water bath temperature acquired by the second temperature sensor 24 reaches the set preheating temperature. Along with the flowing of the detection liquid, the detection liquid flows into the solution tank 401, the temperature of the detection liquid is collected through the first temperature sensor 23, the consistency degree of the temperatures in the solution tanks is fed back, and then the temperature of the detection liquid is controlled better. The third temperature sensor detects the temperature of the heating substrate 14 in real time and feeds back the temperature to the temperature controller, and when the temperature of the heating substrate does not reach the set temperature, the temperature controller controls the heating substrate 14 to start heating.
The CGM electrode detection tool further comprises a sensor support 26, a plurality of sensor fixing plates are arranged on the sensor support 26, and a plurality of electrodes to be detected or electrodes which are detected are arranged on the sensor fixing plates.
Example two
The invention also provides a CGM electrode detection method, which is applied to the CGM electrode detection tool and comprises the following steps:
s1, preparing electrodes to be tested, namely directly cutting out a plurality of electrodes or a single electrode from an electrode preparation substrate, and mounting the electrodes or the single electrode on a test assembly;
s2, simulating human body environment, applying power by a peristaltic pump, and enabling test liquid in the reagent bottle to flow through the solution tank at the speed of flowing human tissue liquid;
s3, collecting test data, conducting electric signals by the circuit board and the contact to be detected, keeping the electrode to be detected immersed in the flowing test liquid for a plurality of days, reacting the electrode to be detected with glucose in the test liquid to generate a current signal, and continuously feeding the current signal back to the data processing component;
s4, standard data are collected, and the glucose content in the test liquid is detected through a standard electrode at intervals and is used as standard data to be recorded;
s5, data processing, namely comparing the test data with the standard data, and judging whether the electrode to be tested meets the standard.
Specifically, for different indexes, the corresponding data processing manners are different, so before step S1, different data processing methods need to be adopted according to different test indexes to obtain the corresponding indexes. The method is divided into different measurement modes according to different test indexes, including stability test, temperature response test, anti-interference test, linear test, response time test and repeatability test.
When stability test is carried out, the electrode to be tested is continuously arranged in flowing test liquid for 7-14 days; the sampling interval t is set to 3min, and the data processing assembly records the response current I of the 1 st, 2 nd and 3 rd times of 480 th times of electrodes to be detected within 24 h. Then, calculating a standard deviation SD of the response current in the electrode 24h to be measured, wherein the standard deviation SD calculating method comprises the following steps:
wherein I is n The response current for the nth test over 24h is represented, n=1, 2, … …, 480;represents the response current average value, N represents the current value sample size;
the response current variation coefficient CV in the electrode 24h to be measured is calculated, and the calculation method of the variation coefficient CV is as follows:
during temperature response test, simulating the blood sugar concentration of a human body, and sequentially selecting test solutions with the glucose concentrations of X1, X2 and X3.; simulating the temperature change of a human body, storing test liquid with the glucose concentration of X1, X2 and X3...Xn by a heating device, and heating the test liquid in a solution tank by a heating substrate to enable the temperature of the test liquid with the same concentration to sequentially reach 34 ℃, 38 ℃ and 42 ℃ in the test process; simulating the flow of human tissue fluid, testing the test fluid with the concentration of X1, and continuously completing the glucose test with the concentration of X2, X3 and X4.. The data processing assembly records the response current of the electrode to be measured in the glucose solution with n concentrations at each temperature.
The method for calculating the response current linear correlation coefficient r value of the electrode to be measured comprises the following steps:
wherein r is n A linear correlation coefficient representing the nth temperature, n=1, 2,3;
X i represents the ith glucose concentration, Y i Indicating the i-th response current,mean value of glucose concentration>Represents the response current average value, N represents the sample size;
calculating the relative deviation of the linear correlation coefficient of the response current of the electrode to be measured, wherein the relative deviation d of the linear correlation coefficient n The calculation method of (1) is as follows:
wherein d n Representing the relative deviation of the linear correlation coefficient of the nth sensor,representing the average linear correlation coefficient.
When an anti-interference test is carried out, simulating the blood glucose concentration of a human body, and selecting two glucose test liquids with different concentrations; simulating the temperature of a human body, storing two glucose test solutions with different concentrations, and heating the test solutions to enable the temperature to reach 36-37 ℃ in the test process; using glucose test solution with a first concentration, and collecting response current I1 on an electrode to be tested after the glucose test solution runs stably for 30min under the flowing state of the test solution;
introducing quantitative ascorbic acid into glucose test solution with first concentration, flowing the test solution for 30-50min, and collecting response current 12 of an electrode to be tested after the response current of a standard electrode is stable; then glucose test solution with the second concentration is used, and after the glucose test solution is stably operated for 30min in a flowing state of the test solution, response current I3 on the electrode to be tested is collected; and (3) introducing quantitative acetaminophen into glucose test solution with a second concentration, flowing the test solution for 30-50min, and collecting response current I4 of the electrode to be tested after the response current of the standard electrode is stable.
Calculating the current change rates alpha of the response currents I1 and I2 1 The method specifically comprises the following steps:
calculating the current change rate alpha of the response currents 13 and I4 2 The method specifically comprises the following steps:
when a linear test, a response time test or a repeatability test is carried out, simulating the blood glucose concentration of a human body, and selecting n glucose test liquids with different concentrations, wherein n is an integer greater than 2; simulating the temperature of a human body, storing n glucose test solutions with different concentrations by a heating device, and heating the test solutions to enable the temperature to reach 36-37 ℃ in the test process; using glucose test solution with a first concentration, and collecting response current I1 on an electrode to be tested after the glucose test solution runs stably for 30min under the flowing state of the test solution;
using glucose test solution with a second concentration, after the glucose test solution runs stably for 30min under the flowing state of the test solution, collecting steady-state response current I2 on the electrode to be tested, and recording time t2 when the response current reaches a steady state;
and testing and data acquisition are sequentially carried out on glucose test solutions with the rest concentrations, so that steady-state response currents I3 and I4 … … In and time t3 and t4 … … tn are obtained.
Calculating response current value linear correlation coefficients r of m electrodes to be measured under n concentrations;
calculating the relative deviation d of the linear correlation coefficient of response current values of m electrodes to be measured under n concentrations n ：
Wherein d n Representing the relative deviation of the linear correlation coefficient of the nth sensor, r n Representing the linear correlation coefficient of the nth sensor,representing the average linear correlation coefficient.
Calculating the standard deviation SD of response currents of m electrodes to be tested under n concentrations:
wherein I is n N=1, 2,3 … … N, which represents the nth current value at the same concentration;represents the response current average value at the same concentration, and N represents the current value sample size.
Calculating response current variation coefficients CV of m electrodes to be measured under n concentrations:
the average value of the current at the same concentration is shown.
Calculate the time t required for the response current to change with each 1mmolL of glucose:
t＝T/m
where T represents the time taken from the former steady state to the latter steady state, and m represents the amount of change in glucose concentration.
The above embodiments are only for illustrating the technical solution of the present invention and not for limiting the same, and although the present invention has been described in detail with reference to examples, it should be understood by those skilled in the art that modifications and equivalents may be made thereto without departing from the scope of the technical solution of the present invention, which is intended to be covered by the claims of the present invention.
Claims (16)
1. CGM electrode detects frock, its characterized in that includes:
the liquid supply assembly drives the test liquid in the reagent bottle to flow through the detection plate of the test assembly through the conveying pipeline by the first peristaltic pump;
the testing component is used for driving the electrode to be tested to be immersed in the testing liquid flowing in the detection plate, and the circuit board is connected with the electrode to be tested and used for collecting the reaction current of the electrode to be tested and transmitting the reaction current to the data processing component;
the temperature feedback control assembly comprises a third temperature sensor and first temperature sensors corresponding to the number of the electrodes to be detected, wherein the first temperature sensors move to flowing test liquid along with the electrodes to be detected, the first temperature sensors detect the temperature of the test liquid in real time, the third temperature sensors are arranged on the heating substrate, the signal output ends of the third temperature sensors are connected with a temperature controller, and the temperature controller is connected with and controls the test liquid in the heating substrate heating solution tank to reach a set temperature.
2. The CGM electrode detection tool according to claim 1, wherein the liquid supply assembly comprises a reagent bottle, a liquid inlet rotary valve and a liquid inlet peristaltic pump, wherein a liquid outlet pipe and a liquid inlet pipe are inserted into the reagent bottle, the liquid outlet pipe is connected with a liquid inlet of the liquid inlet rotary valve, a liquid outlet of the liquid inlet rotary valve is connected with a conveying pipeline, and the conveying pipeline penetrates through the liquid inlet peristaltic pump to be connected with a liquid inlet end of the detection plate.
3. The CGM electrode detection tool according to claim 2, wherein the liquid supply assembly further comprises a liquid outlet rotary valve and a liquid outlet peristaltic pump, the liquid outlet end of the detection plate passes through the liquid outlet peristaltic pump through a conveying pipeline and is connected with the liquid inlet of the liquid outlet rotary valve, and the liquid outlet of the liquid outlet rotary valve is connected with the reagent bottle.
4. The CGM electrode detection tool according to claim 2 or 3, wherein the number of the reagent bottles is not less than two, and the reagent bottles are provided in the heating device.
5. The CGM electrode detection tool according to claim 1, wherein the test assembly comprises a detection plate, a driving unit and a mounting unit; the electrode to be measured is fixed on the mounting unit, the driving unit comprises a Y-axis moving part and a Z-axis moving part, the Y-axis moving part drives the circuit board to move towards one side of the electrode to be measured and contact with the electrode to be measured to realize signal conduction, and the Z-axis moving part drives the mounting unit, the electrode to be measured and the Y-axis moving part to move downwards together so that the electrode to be measured is immersed in flowing test liquid.
6. The CGM electrode detection tool according to claim 5, wherein the Y-axis moving member comprises a cross plate fixed to a Y-axis substrate; the Y-axis motor is arranged on the transverse plate, vertical plates are arranged on two sides of the transverse plate, guide rails are arranged on the upper surfaces of the vertical plates, the upper parts of the guide rails are connected with an upper supporting plate in a sliding mode through sliding blocks, and the Y-axis motor drives the upper supporting plate to horizontally reciprocate through a screw rod mechanism; the upper supporting plate is connected with the bottom plate through vertical plates arranged at two ends, the bottom plate is fixedly connected with the compression driving block, and a circuit board is arranged on the side wall of the compression driving block opposite to the mounting unit.
7. The CGM electrode detection tool according to claim 5, wherein the circuit board is provided with an elastic contact point, and the electrode to be detected is provided with a contact point which is in contact with and conducted with a signal point of the circuit board.
8. The CGM electrode detection tool according to claim 7, wherein the electrode to be detected is an electrode sheet sequentially connected through a base material, the electrode sheet comprises a test portion and a base material, the test portion protrudes out of the base material, fixing portions are cut out at two ends of the electrode sheet, fixing holes are formed in the fixing portions in a penetrating mode, and the electrode sheet is clamped on the mounting unit through the fixing holes.
9. The CGM electrode detection tool according to claim 7, wherein the electrode to be detected is a single electrode cut out from the base material, and the electrode is clamped on the mounting unit through a fixing hole formed therethrough.
10. The CGM electrode detection tool according to claim 8 or 9, wherein the mounting unit comprises a fixing plate and a connecting plate, a slide rail is provided on the rear end surface of the fixing plate, and a fixing groove for engaging an electrode to be detected is provided on the front end surface of the fixing plate; the fixed slot is provided with a fixed bulge corresponding to the electrode to be detected, the sliding rail is in sliding connection with the connecting plate through a sliding groove, the side wall of the fixed plate is also provided with a limiting rod in a protruding mode, the connecting plate is provided with a limiting slot corresponding to the limiting rod, the limiting rod horizontally penetrates through the limiting slot of the connecting plate, and the connecting plate is fixed on the Y-axis moving part.
11. The CGM electrode detection tool according to claim 2, wherein the detection plate is fixed by a bracket, and a heating substrate is provided between a lower end surface of the detection plate and the bracket.
12. The CGM electrode detection tool according to claim 11, wherein a plurality of solution grooves with circular arc-shaped cross sections are concavely formed in the upper end face of the detection plate, one end of each solution groove is communicated with the liquid inlet end, the other end of each solution groove is communicated with the liquid outlet end, at least two mixing plates are arranged in the solution groove close to the liquid inlet end, a plurality of through holes are horizontally formed in the mixing plates, and the through holes between two adjacent mixing plates are staggered.
13. The CGM electrode detection tool according to claim 11, wherein a cover plate is disposed above the detection plate, a first opening and a second opening corresponding to the solution tank are formed in the cover plate, and the first opening and the second opening are respectively used for passing through the electrode to be detected and the first temperature sensor.
14. A CGM electrode detection method applied to the CGM electrode detection tool according to any one of claims 1 to 13, characterized by comprising:
s1, preparing electrodes to be tested, namely directly cutting out a plurality of electrodes or a single electrode from an electrode preparation substrate, and mounting the electrodes or the single electrode on a test assembly;
s2, simulating human body environment, applying power by a peristaltic pump, and enabling test liquid in the reagent bottle to flow through the solution tank at the speed of flowing human tissue liquid;
s3, collecting test data, conducting electric signals by the circuit board and the contact to be detected, keeping the electrode to be detected immersed in the flowing test liquid for a plurality of days, reacting the electrode to be detected with glucose in the test liquid to generate a current signal, and continuously feeding the current signal back to the data processing component;
s4, standard data are collected, and the glucose content in the test liquid is detected through a standard electrode at intervals and is used as standard data to be recorded;
s5, data processing, namely comparing the test data with the standard data, and judging whether the electrode to be tested meets the standard.
15. The CGM electrode detection method according to claim 14, wherein simulating the human environment further comprises,
s21, simulating blood sugar changes, configuring test solutions with different concentrations in a plurality of reagent bottles, and selecting the test solution in the corresponding reagent bottle according to different test environments;
s22, simulating temperature change of tissue fluid, preheating and heating the test fluid, preheating the test fluid in the reagent bottle by using a heating device, and heating the test fluid in the solution tank by using a heating substrate, so that the temperature of the test fluid tested by the electrode to be tested is set.
16. The CGM electrode detection method according to claim 14, wherein in the step S3, the depth of the electrode to be detected immersed in the test liquid is 5 to 7mm after the level of the test liquid in the solution tank becomes stable.
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