An integrated solid-state electrode electrolyte analysis module

By designing an integrated solid-state electrode electrolyte analysis module, the problems of unstable, inconvenient and high cost in existing electrolyte analyzers are solved, and higher detection accuracy and efficiency are achieved, reducing detection cost and maintenance complexity.

CN119757493APending Publication Date: 2025-04-04SICHUAN XINCHENG BIOLOGICAL CO LTD
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Patent Information

Application Number
CN202510000963.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-02
Publication Date
2025-04-04

AI Technical Summary

Technical Problem

Existing electrolyte analyzers use independent large ion selective electrodes, which leads to easy dislocation of assembly connections, unstable electrodes, inconvenient maintenance, and high cost. Reduced liquid filling in the electrodes will lead to unstable electrodes, affecting the test results.

Method used

Design an integrated solid-state electrode electrolyte analysis module, adopting an integrated electrode analysis module, pump and valve module and kit module, which is connected through pipelines. The pump and valve module controls liquid exchange and completes the test process. All ion selective electrodes are integrated on the electrode card and solid electrodes are used to avoid the problem of reduced internal liquid filling.

Benefits of technology

It improves detection accuracy and efficiency, reduces detection cost and maintenance complexity, avoids the impact of test results caused by electrode instability, enhances the stability of the electrode, and can be assembled on a fully automatic biochemical analyzer to reduce the probability of sample errors.

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Abstract

The present invention discloses an integrated solid-state electrode electrolyte analysis module, including an integrated electrode analysis module, a pump-valve module and a test kit module, wherein the liquid outlet of the test kit module is connected to the pump-valve module through a pipeline, and the liquid inlet and waste liquid outlet of the integrated electrode analysis module are connected to the pump-valve module through a pipeline. All ion selective electrodes Li+, Na+, K+, Cl-, Ref, etc. of the present invention are all integrated into an electrode card, reducing the number of electrodes, and only need to replace the electrode card, thereby reducing the cost and the difficulty of maintenance; avoiding problems in the connection between electrodes and electrodes, thereby affecting the test results, and enhancing the stability of the electrode; the electrode card uses a solid-state ion electrode, and there is no internal filling liquid inside, and the internal filling liquid reduction after a period of use of the electrode will cause the electrode to be unstable, thus affecting the test results; it can be assembled to a fully automatic biochemical analyzer for use, which can greatly reduce the probability of sample errors, and at the same time can improve the test speed and test efficiency.
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Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to an integrated solid-state electrode electrolyte analysis module. Background Art

[0002] The electrolyte analyzers on the market use ion-selective electrodes, in which each ion Li+, Na+, K+, Cl-, Ref, etc. is an independent electrode. The electrodes are large in size and of many types, making it inconvenient to replace and maintain the electrodes. The electrodes used in electrolyte analyzers have a reduced internal filling liquid after a period of use, which can cause electrode instability and affect test results.

[0003] At present, hospitals test the same sample on both an electrolyte analyzer and a biochemical analyzer, which can easily lead to errors in the sample packaging or movement process. For large hospitals with a large number of samples, single-machine electrolyte analyzer testing requires a lot of manpower and material resources, is inefficient, and is not convenient and fast.

[0004] The methods used to measure the concentrations of potassium ions, sodium ions, calcium ions, chloride ions, pH, etc. include non-integrated large electrode electrolyte analyzers, non-integrated large electrode electrolyte modules, and biochemical colorimetric enzyme reagents. For hospitals with a large demand for sample testing, it is necessary to meet both high-intensity sample volume testing and accuracy requirements, but the existing domestic technology cannot comprehensively meet this application scenario in terms of maintainability, efficiency, accuracy, and cost.

[0005] Current electrolyte analysis modules all use independent large ion-selective electrodes, that is, a corresponding ion-selective electrode is required to measure each ion. The assembly connection between electrodes is easily misaligned, resulting in internal test channel obstruction, which can cause electrode instability and affect test results. Multiple electrodes are not convenient to replace and maintain, and the cost of independent electrodes is high.

[0006] The ion selective electrodes used in the currently used electrolyte analysis modules are all filled with internal liquid. After a period of use, the internal liquid of the electrode will decrease, causing the electrode to be unstable and affecting the test results.

[0007] Therefore, there is an urgent need to provide an integrated solid-state electrode electrolyte analysis module that can be installed on a fully automatic biochemical analyzer. Summary of the invention

[0008] The purpose of the present invention is to overcome the problems raised in the above-mentioned background technology, and to provide an integrated solid-state electrode electrolyte analysis module, which is used in conjunction with a fully automatic biochemical analyzer to quantitatively detect human vital indicators such as sodium ions, potassium ions, calcium ions, chloride ions, and pH, thereby improving the accuracy and efficiency of traditional fully automatic biochemical analyzers in detecting such indicators, and reducing detection costs, maintenance complexity, etc.

[0009] The purpose of the present invention is mainly achieved through the following technical solutions: An integrated solid-state electrode electrolyte analysis module includes an integrated electrode analysis module, a pump-valve module and a reagent kit module, wherein the liquid outlet of the reagent kit module is connected to the pump-valve module through a pipeline, and the liquid inlet and waste liquid outlet of the integrated electrode analysis module are connected to the pump-valve module through a pipeline. The current electrolyte analysis modules all use independent ion-selective large electrodes, that is, a corresponding ion-selective electrode is required to measure each ion, and the assembly connection between electrodes is easily misaligned, resulting in a blocked internal test channel, which will cause the electrode to be unstable and affect the test results. Multiple electrodes are not convenient to replace and maintain, and the cost of independent electrodes is relatively high. Moreover, the ion-selective electrodes used in the electrolyte analysis module are filled with internal filling liquid. After a period of use, the filling liquid in the electrode will decrease, resulting in unstable electrodes and affecting the test results. In order to solve the above problems, this scheme designs an integrated solid-state electrode electrolyte analysis module, which uses an integrated electrode analysis module, a pump valve module and a reagent kit module. The liquid outlet of the reagent kit module is connected to the pump valve module through a pipeline, and the liquid inlet and waste liquid outlet of the integrated electrode analysis module are connected to the pump valve module through a pipeline. The pump valve module controls the liquid exchange between the integrated analysis module and the reagent kit module to complete the entire test process. It is used with a fully automatic biochemical analyzer to quantitatively detect human vital indicators such as sodium ions, potassium ions, calcium ions, chloride ions, and pH, which improves the accuracy and efficiency of traditional fully automatic biochemical analyzers in detecting this type of indicators, and reduces detection costs and maintenance complexity.

[0010] Furthermore, the integrated electrode analysis module includes a shell, the cavity of the shell is provided with a main board and an electrode card compartment, the electrode card is installed in the electrode card compartment, the main board and the electrode card are connected, and an injection port is provided on the top of the shell, which is connected to the pump valve module and the electrode card at the same time. The electrode card is installed through the electrode card compartment, and the electrode card compartment plays the role of fixing the electrode card and connecting the liquid path. The electrode card is installed on the electrode card compartment, and a liquid path interface is provided on the electrode card compartment, which is connected to the liquid outlet of the electrode card. After the electrode card test is completed, the waste liquid flows into the waste liquid bag in the reagent kit module through the electrode card compartment controlled by the pump valve module. A reagent bag and a waste liquid bag are provided inside the reagent kit module.

[0011] Furthermore, the injection port is provided with two liquid inlets, one of which is connected to the pump valve module through a pipeline, and the other is the sample inlet, and the two liquid inlets are used to infuse corresponding liquids to prevent inlet congestion. The liquid outlet of the injection port is connected to the liquid inlet of the electrode card through a clamping knob, and the liquid outlet of the injection port is designed as a funnel structure to introduce the liquid infused from the inlet into the liquid inlet of the electrode card. A sealing ring is provided between the liquid outlet of the injection port and the liquid inlet of the electrode card to ensure the airtightness of the connection between them.

[0012] Further, the electrode card includes an electrode card housing, a chip, and a sealing ring. The chip and the sealing ring are both arranged in the electrode card housing, and the sealing ring closes the liquid inlet and liquid outlet of the electrode card. There is a liquid channel inside the electrode card housing, and the inside of the liquid channel is connected to the ion selective electrode on the chip; the main board is connected to the chip on the electrode card through a probe, and the liquid passing through the liquid channel will contact the ion selective electrode on the chip. After the potential difference is generated, the main board collects the signal and analyzes and calculates the ion concentration to complete the measurement of the sample. The main board collects the electrical signal generated on the electrode card through the probe, and can analyze the electrical signal at the same time and convert it into the corresponding ion concentration. Sealing rings are installed at the liquid inlet and liquid outlet of the electrode card to ensure the airtightness of the connection with other components.

[0013] The mainboard is connected to the pump-valve module via a cable to control the pump-valve module to complete the entire test process. The mainboard can receive user operation information through the serial port and transmit the test results to the PC.

[0014] The pump-valve module includes a peristaltic pump and a solenoid valve. The mainboard controls the operation of the peristaltic pump and the on-off of the solenoid valve to complete the liquid exchange between the test kit module and the integrated analysis module, completing the entire test process.

[0015] In summary, the present invention has the following beneficial effects compared with the prior art: (1) All ion selective electrodes of the present invention, such as Li+, Na+, K+, Cl-, Ref, etc., are integrated into one electrode card, which reduces the number of electrodes and only requires the replacement of the electrode card, thereby reducing the cost and maintenance difficulty. At the same time, the connection problems between electrodes are avoided, which may affect the test results and enhance the stability of the electrodes. (2) The electrode card of the present invention uses a solid ion electrode and has no internal filling liquid. Therefore, the electrode will not be unstable due to the reduction of the internal filling liquid after a period of use, thus affecting the test results. (3) The present invention can be assembled on a fully automatic biochemical analyzer, which can greatly reduce the probability of sample errors and improve the test speed and efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The drawings described herein are used to provide a further understanding of the embodiments of the present invention, constitute a part of this application, and do not constitute a limitation of the embodiments of the present invention. In the drawings: Figure 1 It is a schematic diagram of the combination of the present invention.

[0017] Figure 2 Schematic diagram of the structure of the integrated electrode analysis module.

[0018] Figure 3 A cross-sectional view of the integrated electrode analysis module.

[0019] Figure 4 Schematic diagram of the structure of the electrode card.

[0020] The names corresponding to the reference numerals in the accompanying drawings are: 1-integrated electrode analysis module, 1-1-liquid inlet 1, 1-2-housing, 1-3-electrode card, 1-4-electrode card compartment, 1-5-liquid inlet 2, 1-6-pressing knob, 1-7-electrode card liquid inlet, 1-8-electrode card housing, 1-9-chip, 1-10-electrode card liquid outlet, 1-11-mainboard, 1-12-inlet, 2-pump valve module, 3-reactor module. DETAILED DESCRIPTION

[0021] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0022] In the description of the present invention, it is necessary to understand that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "lateral, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the drawings. They are only for the convenience of describing the present invention and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the devices or elements referred to must have a specific direction or be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the scope of protection of the present invention. The directional words "inside and outside" refer to the inside and outside relative to the contours of each component itself.

[0023] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. If not otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the present invention.

[0024] like Figures 1 to 4As shown, an integrated solid-state electrode electrolyte analysis module of this embodiment is used in conjunction with a fully automatic biochemical analyzer to quantitatively detect human vital indicators such as sodium ions, potassium ions, calcium ions, chloride ions, and pH, thereby improving the accuracy and efficiency of traditional fully automatic biochemical analyzers in detecting such indicators, reducing detection costs, maintenance complexity, etc., and belonging to the field of medical device technology.

[0025] The main structure includes an integrated electrode analysis module 1, a pump valve module 2 and a reagent kit module 3, wherein the liquid outlet of the reagent kit module 3 is connected to the pump valve module 2 through a pipeline, and the liquid inlet and the waste liquid outlet of the integrated electrode analysis module 1 are connected to the pump valve module 2 through a pipeline, and the pump valve module 2 controls the liquid exchange between the integrated analysis module 1 and the reagent kit module 3 to complete the entire test process. The integrated electrode analysis module 1 includes a shell 1-2, a main board 1-11 and an electrode card compartment 1-4 are arranged in the cavity of the shell 1-2, an electrode card 1-3 is installed in the electrode card compartment 1-4, the main board 1-11 and the electrode card 1-3 are connected, an injection port 1-12 is arranged on the top of the shell 1-2, and the injection port 1-12 is connected to the pump valve module 2 and the electrode card 1-3 at the same time, and the electrode card 1-3 is installed through the electrode card compartment 1-4, and the electrode card compartment 1-4 plays the role of fixing the electrode card 1-3 and connecting the liquid path. The electrode card 1-3 is installed on the electrode card compartment 1-4, and a liquid path interface is provided on the electrode card compartment 1-4, which is connected to the electrode card liquid outlet 1-10. After the electrode card 1-3 is tested, the waste liquid flows into the waste liquid bag in the reagent kit module 3 through the electrode card compartment 1-4 controlled by the pump valve module 2. With the integrated electrode card, the electrode is highly integrated, which is convenient for maintenance and replacement and reduces costs.

[0026] Two liquid inlets are provided on the injection port 1-12, respectively named as liquid inlet one 1-1 and liquid inlet two 1-5, liquid inlet one 1-1 is connected with pump valve module 2 through pipeline, and liquid inlet two 1-5 is the inlet of sample. Two liquid inlets are respectively used for filling corresponding liquid to prevent the inlet from being blocked. The liquid outlet at the injection port 1-12 is connected with the liquid inlet of the electrode card 1-3 by pressing knob 1-6, and the liquid outlet at the injection port is designed as a funnel structure, and the liquid filled by the inlet is introduced into the liquid inlet 1-7 of the electrode card, and rotated by pressing knob 1-6, the liquid outlet of the injection port 1-12 is pressed to the liquid inlet of the electrode card 1-3 for connection, so that liquid can enter circulation correspondingly. A sealing ring is provided between the liquid outlet of the injection port 1-12 and the liquid inlet of the electrode card 1-3 to ensure the airtightness of the connection between them.

[0027] This scheme adopts solid electrodes, and there is no internal filling liquid in the electrode card 1-3. A more stable solid electrode is used to prevent the electrode from being unstable due to the reduction of internal filling liquid after a period of use, which affects the test results. The electrode card 1-3 includes an electrode card shell 1-8, a chip 1-9, and a sealing ring. The chip 1-9 and the sealing ring are both arranged in the electrode card shell 1-8, and the sealing ring closes the liquid inlet and liquid outlet of the electrode card 1-3. There is a liquid channel inside the electrode card shell 1-8, and the inside of the liquid channel is connected to the ion selective electrode on the chip 1-9; the main board 1-11 is connected to the chip on the electrode card 1-3 through a probe, and the liquid passing through the liquid channel will contact the ion selective electrode on the chip. After the potential difference is generated, the main board collects the signal and analyzes and calculates the ion concentration to complete the measurement of the sample. The main board 1-11 collects the electrical signal generated on the electrode card 1-3 through the probe, and can analyze the electrical signal at the same time and convert it into the corresponding ion concentration. Sealing rings are installed at the electrode card liquid inlet 1-7 and the electrode card liquid outlet 1-10 to ensure the airtightness of the connection with other components.

[0028] The mainboard 1-11 is connected to the pump valve module 2 through a cable, and is used to control the pump valve module 2 to run and complete the entire test process. The mainboard 1-11 can receive user operation information through the serial port and transmit the test results to the PC end.

[0029] This solution is installed on a fully automatic biochemical analyzer and can greatly reduce the probability of sample errors, while improving test speed and efficiency.

[0030] The workflow is as follows: 1. Test process: The sample is drawn from the sample cup or original blood collection tube placed at the corresponding position of the sample tray by the sampling needle of the fully automatic biochemical analyzer, and injected into the injection port 1-12 on the top of the integrated analysis module 1, and the bubbles in the sample are automatically eliminated in the inner cavity of the injection port; the main board 1-11 of the integrated analysis module 1 receives the user's operation information, controls the operation of the pump valve module 2 to move the sample from the injection port to the inside of the electrode card 1-3, and after the main board 1-11 connects with the electrode card through the probe to collect the signal, it analyzes and calculates the test result, and transmits the test result to the PC through the serial port; after the test is completed, the sample is controlled by the pump valve module 2 to flow into the waste liquid bag in the reagent kit module 3.

[0031] 2. Calibration and cleaning process: When the module runs the cleaning and calibration process, the mainboard controls the pump and valve module 2 to absorb the corresponding reagent from the reagent kit module 3, and injects it into the inner cavity of the injection port through the liquid inlet 1-1 on the injection port. The bubbles in the reagent are automatically eliminated in the inner cavity of the injection port. The mainboard controls the pump and valve module 2 to move the reagent to the inside of the electrode card for sampling to complete calibration or clean the liquid path. After the action is completed, the waste liquid is controlled by the pump and valve module 2 to flow into the waste liquid bag in the reagent kit module 3.

[0032] 3. Replacement of electrode card process: Loosen the clamping knob to disconnect the connection between the injection port and the electrode card, pull the handle on the electrode card compartment to open the electrode card compartment 1-4, then take out the old electrode card and insert the new electrode card, then close the electrode card compartment 1-4 by the handle, and then tighten the clamping knob to make the injection port and the electrode card tightly connected to complete the replacement of the electrode card.

[0033] All ion selective electrodes Li+, Na+, K+, Cl-, Ref, etc. of the present invention are integrated into one electrode card, the number of electrodes is reduced, and only the electrode card needs to be replaced, thus reducing the cost and the difficulty of maintenance; at the same time, problems in the connection between electrodes are avoided to affect the test results, thereby enhancing the stability of the electrodes; the electrode card of the present invention uses solid ion electrodes, and there is no internal filling liquid inside, so the electrode filling liquid will not be reduced after a period of use, resulting in electrode instability and affecting the test results; the present invention can be assembled on a fully automatic biochemical analyzer for use, which can greatly reduce the probability of sample errors, and at the same time can improve the test speed and test efficiency.

[0034] The contents not described in detail in this specification belong to the prior art known to the professional and technical personnel in this field. The standard parts used in the present invention can be purchased from the market, and the special-shaped parts can be customized according to the description and the drawings. The specific connection methods of each part adopt the conventional means such as mature bolts, rivets, welding, etc. in the prior art. The machinery, parts and equipment all adopt the conventional models in the prior art, and the circuit connection adopts the conventional connection method in the prior art, which will not be described in detail here.

[0035] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An integrated solid-state electrode electrolyte analysis module, characterized in that: It comprises an integrated electrode analysis module (1), a pump-valve module (2) and a reagent box module (3), wherein the liquid outlet of the reagent box module (3) is connected to the pump-valve module (2) via a pipeline, and the liquid inlet and waste liquid outlet of the integrated electrode analysis module (1) are connected to the pump-valve module (2) via a pipeline.

2. An integrated solid-state electrode electrolyte analysis module according to claim 1, characterized in that: The integrated electrode analysis module (1) comprises a housing (1-2); a mainboard (1-11) and an electrode card compartment (1-4) are arranged in a cavity of the housing (1-2); an electrode card (1-3) is installed in the electrode card compartment (1-4); the mainboard (1-11) and the electrode card (1-3) are connected; a sample inlet (1-12) is arranged on the top of the housing (1-2); and the sample inlet (1-12) is connected to both the pump valve module (2) and the electrode card (1-3).

3. An integrated solid-state electrode electrolyte analysis module according to claim 2, characterized in that: The injection port (1-12) is provided with two liquid inlets, one of which is connected to the pump valve module (2) via a pipeline, and the other is an inlet for the sample; the liquid outlet of the injection port (1-12) is connected to the liquid inlet of the electrode card (1-3) via a pressing knob (1-6), and a sealing ring is provided between the liquid outlet of the injection port (1-12) and the liquid inlet of the electrode card (1-3).

4. The integrated solid-state electrode electrolyte analysis module according to claim 3, characterized in that: The electrode card (1-3) comprises an electrode card housing (1-8), a chip (1-9), and a sealing ring. The chip (1-9) and the sealing ring are both arranged in the electrode card housing (1-8), and the sealing ring seals the liquid inlet and liquid outlet of the electrode card (1-3). A liquid channel is provided inside the electrode card housing (1-8), and the inside of the liquid channel is connected to the ion selective electrode on the chip (1-9). The main board (1-11) is connected to the chip on the electrode card (1-3) via a probe, and the liquid passing through the liquid channel contacts the ion selective electrode on the chip, and after a potential difference is generated, the main board collects signals and analyzes and calculates ion concentrations, thereby completing the measurement of the sample.

5. The integrated solid-state electrode electrolyte analysis module according to claim 2, characterized in that: The mainboard (1-11) is connected to the pump valve module (2) via a cable, and is used to control the pump valve module (2) to run and complete the entire test process.

6. The integrated solid-state electrode electrolyte analysis module according to claim 4, characterized in that: The electrode card compartment (1-4) is provided with a liquid path interface which is connected to the liquid outlet of the electrode card (1-3).