A testing tool for the working electrode of a continuous glucose monitoring system

Abstract

This utility model belongs to the field of glucose detection, specifically relating to a testing tool for the working electrode of a continuous glucose detection system. It includes: a leveling device to provide a consistently horizontal platform for the working electrode during testing; a constant-temperature heating device disposed on the horizontal platform, the heating device being equipped with a test solution tank to provide a constant temperature for the working electrode testing, ensuring temperature stability; and a testing fixture disposed above the test solution tank, the fixture being equipped with multiple needle-holding plates for fixing the working electrode. This utility model's entire testing tool can simultaneously test multiple sets of working electrodes, greatly increasing testing efficiency. Furthermore, through control of levelness and test solution temperature, the consistency of test results is better. It has a simple structure, low manufacturing cost, and can be easily replicated.

Description

Technical Field

[0001] This utility model belongs to the field of glucose detection, specifically relating to a testing tool for the working electrode of a continuous glucose detection system. Background Technology

[0002] According to data from the International Diabetes Federation's (IDF) Global Diabetes Atlas, the number of adults with diabetes worldwide reached 537 million in 2021, with a compound annual growth rate of approximately 3.91% from 2011 to 2021. This represents about 10% of the global population, and is projected to reach 643 million by 2030. In China, the number of adults with diabetes reached 141 million in 2021, and is projected to reach 164 million and 174 million by 2030 and 2045, respectively. The IDF estimates that approximately 51.7% of adults with diabetes in China in 2021 were undiagnosed, primarily due to a lack of self-monitoring devices and the invasiveness and inconvenience of existing devices, making users reluctant to use them. In recent years, Continuous Glucose Monitor Systems (CGMS) have gradually gained recognition in domestic and international markets, and blood glucose fluctuation parameters based on CGMS data have been widely applied in clinical practice. Unlike single-point blood glucose measurements represented by blood glucose test strips, CGMS systems can effectively reflect the relationship between daily activities and blood glucose changes in diabetic patients, facilitating rational medication use by doctors and patients. The working electrodes of existing CGMS systems on the market mainly consist of a substrate, a metal electrochemical layer, a glucose oxidase layer, and a diffusion restriction layer. The main principle is that glucose oxidase catalyzes the decomposition of glucose into hydrogen peroxide. The electrode captures the electrochemical signal of this reaction, and the signal intensity has a linear relationship with the glucose concentration. The glucose concentration can be calculated by converting the signal intensity, thus achieving the purpose of monitoring glucose concentration.

[0003] The microstructure of the diffusion confinement layer on a CGMS is related to factors such as the temperature and humidity of the processing environment and the microstructure of the electrode surface. It is difficult to replicate an identical CGMS using technical means, resulting in variations in the sensitivity of each CGMS working electrode. Therefore, traditional CGMS require patients to test their blood glucose levels within 1-2 hours of wearing the device and input the results into the CGMS to complete the working electrode calibration. Even using a more convenient method like finger-prick blood testing can be inconvenient and cause discomfort for patients. To address these issues, more and more CGMS systems are implementing "factory calibration," eliminating the need for patients to perform the calibration process before use. The main method for factory calibration is to perform sensitivity testing before the working electrodes are assembled. However, testing each working electrode individually as a circuit is inconvenient and inefficient in actual production. Utility Model Content

[0004] The purpose of this invention is to provide a testing tool for the working electrode of a continuous glucose detection system, which can simultaneously test multiple working electrodes, achieving higher accuracy, and is also simpler to operate and more efficient in testing.

[0005] To achieve the above objectives, the present invention adopts the following technical solution:

[0006] A testing tool for the working electrode of a continuous glucose monitoring system, comprising:

[0007] The leveling device provides a horizontal platform for testing the working electrode at all times;

[0008] A constant temperature heating device is installed on the horizontal platform. The constant temperature heating device is equipped with a test solution tank to provide a constant temperature for the testing of the working electrode and ensure the stability of the test temperature.

[0009] A testing fixture is positioned above the testing solution tank, and the testing fixture is equipped with multiple needle holders for fixing the working electrodes.

[0010] The contact area between the working electrode and the test liquid affects the current signal of the working electrode. If precise control cannot be guaranteed during testing, the test results will be unstable and less reliable. In the above scheme, the leveling device always provides a horizontal platform for the testing of the working electrode. Maintaining a completely horizontal test area is an important condition for ensuring accurate test results. If the overall level cannot be maintained and the test liquid is tilted, the height to which the test liquid submerges the working electrode will be inconsistent, resulting in inconsistent effective reaction lengths of the working electrode and causing sensitivity test deviations.

[0011] The inventors also discovered that the temperature of the test solution also affects the current signal of the working electrode. If the temperature of the test solution is not precisely controlled during testing, it will also lead to unstable test results. In the above solution, the test temperature is controlled by a constant temperature heating device, generally maintaining the temperature of the test solution at (37±1℃). A temperature sensor is placed in the test solution on the heating stage to provide feedback on the test solution temperature and adjust the output power according to the temperature to achieve stable temperature control.

[0012] Preferably, the testing fixture includes a fixture fixing member fixed to the wall of the test solution tank. The fixture fixing member is provided with a fixing groove, and the end of the needle holding plate is engaged with the fixing groove. The needle holding plate testing fixture can be placed precisely into the groove without any back-and-forth or left-and-right wobbling, which can keep the needle holding plate testing fixture stable and ensure that the working electrode under test is always perpendicular to the test liquid surface. Combined with the test liquid level control, the length of the working electrode in contact with the test liquid can be precisely controlled, thus maintaining the stability of the test.

[0013] Preferably, the leveling device includes a support structure, two mating parts symmetrically installed on the support structure, and two height adjusting parts connected to the mating parts by a flat plate, with the leveling platform installed between the two height adjusting parts.

[0014] In this solution, instead of directly adjusting the horizontal position on the support structure, it is achieved through two mating parts and two height-adjusting parts connected to the mating parts by a flat plate, which can further improve stability.

[0015] Preferably, the height adjustment component is an adjustment bolt.

[0016] Preferably, the inner side of the test solution tank wall is provided with a support edge, and the tooling fixture is installed on the support edge.

[0017] Preferably, the needle holder plate includes an inner fixing plate, an outer fixing plate, an intermediate support plate, and conductive posts. The intermediate support plate is clamped and fixed by the inner fixing plate and the outer fixing plate. The working electrode is fixed on the intermediate support plate and externally connected to the test system through the conductive posts.

[0018] Preferably, the conductive pillar is a copper conductive pillar, a silver conductive pillar, or the like.

[0019] Preferably, a level is installed on the horizontal platform.

[0020] By implementing the above technical solution, compared with the prior art, this utility model has the following technical effects:

[0021] The entire testing tool of this utility model: 1. Enables simultaneous testing of multiple working electrodes, reducing the testing area, saving testing fluid, and improving testing efficiency; 2. Precise horizontal control ensures that the testing conditions of each working electrode are completely consistent, reducing testing errors and making the test results more reliable; 3. The needle holder plate with working electrodes is the smallest transfer unit in the production process. Testing is performed directly on the needle holder plate, which facilitates the transfer back to the production line for subsequent assembly and processing after testing. The operation is convenient and avoids the scrapping of working electrodes due to errors in needle removal and reassembly. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the structure of a testing tool according to an embodiment of the present invention;

[0023] Figure 2 This is a schematic diagram of the test fixture shown in one embodiment of the present invention;

[0024] Figure 3 for Figure 2 The diagram shows a cross-sectional view of the test fixture. Detailed Implementation

[0025] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments.

[0026] This specific embodiment is merely an explanation of the present utility model and is not intended to limit the present utility model. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but as long as they are within the scope of the claims of the present utility model, they are protected by patent law.

[0027] Example

[0028] This embodiment provides a testing tool for the working electrode of a continuous glucose monitoring system. See [link to documentation]. Figure 1 It includes: a leveling device 10, a constant temperature heating device 20, and a testing fixture 30.

[0029] The leveling device 10 serves to support the entire testing apparatus, providing a level platform 100 for the testing of the working electrode 50. It includes a support structure 101, two mating parts 102 symmetrically mounted on the support structure 101, and two height-adjusting parts 104 connected to the mating parts 102 via a plate 103. The level platform 100 is installed between the two height-adjusting parts 104. The support structure 101 can be made of any material with a certain length, such as wood or metal; in this embodiment, it is made of stainless steel and has four support legs with reinforcing strips between them to improve stability. A crossbar 10-3 is provided at the top of the support legs. The mating parts 102 are support rods, one end of which is fixed to the crossbar 10-3, and the other end is fixed to a plate 103. The plate 103 has a hole through which the support rod passes and is secured with a nut. The height-adjusting parts 104 are adjusting bolts, one end of which passes through a hole in the plate 103 and is secured with a nut, and the other end is fixed to the level platform 100. A level is installed on the horizontal platform 100 to determine whether the horizontal platform 100 is in a horizontal state.

[0030] The constant temperature heating device 20 is installed on the horizontal platform 100. The constant temperature heating device 20 is equipped with a test solution tank 201 and a temperature control component, similar in structure to a constant temperature water bath. It can control the test solution in the test solution tank at a certain temperature, providing a constant temperature for the working electrode test and ensuring the stability of the test temperature. The constant temperature heating device 20 can be placed directly on the horizontal platform 100, or a mounting groove can be provided on the horizontal platform 100, with the constant temperature heating device 20 fitting perfectly into the mounting groove. This ensures the stability of the constant temperature heating device 20 and prevents it from accidentally slipping.

[0031] The test fixture 30 is used to fix the working electrode to be tested and to bring it into contact with the test solution in the test solution tank of the constant temperature heating device 20. It is positioned above the test solution tank. The test fixture is equipped with multiple needle-holding plates 40 for fixing the working electrodes, allowing for simultaneous testing of multiple working electrodes. (See also...) Figure 2 The testing fixture 30 includes a fixture fixing member 301 fixed to the wall of the test solution tank. Further, a fixing groove 301-1 is provided on the fixture fixing member 301, and the end of the needle holding plate 40 is engaged with the fixing groove. A support edge is provided on the inner side of the test solution tank wall, and the fixture fixing member 301 is installed on the support edge.

[0032] See Figure 3The needle holder plate 40 includes an inner fixing plate 401, an outer fixing plate 402, an intermediate support plate 403, and a conductive post 404. The intermediate support plate 403 is clamped and fixed by the inner fixing plate 401 and the outer fixing plate 402, and the inner fixing plate 401 and the outer fixing plate 402 are locked together with screws. The working electrode is fixed on the intermediate support plate 403, which has a receiving groove for accommodating the working electrode. A pressure strip plate is also provided, with pressure strips on it. Each receiving groove corresponds to one pressure strip, which is used to press the working electrode to secure it. After the working electrode is placed in the receiving groove, the pressure strip plate is detachably fixed to the intermediate support plate 403 with screws to press and fix the working electrode. The end of the working electrode contacts the conductive post 404, and a testing system is externally connected through the conductive post 404 for testing. The conductive post is a copper conductive post or a silver conductive post.

Claims

1. A testing tool for the working electrode of a continuous glucose detection system, characterized in that, include: The leveling device provides a horizontal platform for testing the working electrode at all times; A constant temperature heating device is installed on the horizontal platform. The constant temperature heating device is equipped with a test solution tank to provide a constant temperature for the testing of the working electrode and ensure the stability of the test temperature. A testing fixture is positioned above the testing solution tank, and the testing fixture is equipped with multiple needle holders for fixing the working electrodes.

2. The testing tool for the working electrode of a continuous glucose detection system according to claim 1, characterized in that, The testing fixture includes a fixture fixing component fixed to the wall of the test solution tank. The fixture fixing component is provided with a fixing groove, and the end of the needle holding plate is engaged with the fixing groove.

3. The testing tool for the working electrode of a continuous glucose detection system according to claim 2, characterized in that, The leveling device includes a support structure, two mating parts symmetrically installed on the support structure, and two height adjusting parts connected to the mating parts by a flat plate. The leveling platform is installed between the two height adjusting parts.

4. The testing tool for the working electrode of a continuous glucose detection system according to claim 3, characterized in that, The height adjustment component is an adjusting bolt.

5. The testing tool for the working electrode of a continuous glucose detection system according to claim 2, characterized in that, The inner side of the test solution tank wall is provided with a support edge, and the tooling fixture is installed on the support edge.

6. The testing tool for the working electrode of a continuous glucose detection system according to claim 3, characterized in that, The needle holder plate includes an inner fixing plate, an outer fixing plate, an intermediate support plate, and conductive posts. The intermediate support plate is clamped and fixed by the inner fixing plate and the outer fixing plate. The working electrode is fixed on the intermediate support plate and externally connected to the test system through the conductive posts.

7. The testing tool for the working electrode of a continuous glucose detection system according to claim 6, characterized in that, The conductive pillar is a copper conductive pillar or a silver conductive pillar.

8. The testing tool for the working electrode of a continuous glucose detection system according to claim 1, characterized in that, A level is installed on the horizontal platform.

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