A multifunctional electrochemical biosensor and analyte detection system

Abstract

This invention belongs to the field of sample testing sensor technology, and relates to a multifunctional electrochemical biosensor and analyte testing system. It includes a sensor body externally connected to an analyzer. The sensor body comprises a substrate layer, an electrode layer, and a partition layer stacked sequentially. The partition layer has an injection channel and at least two independent shunt channels. Each shunt channel is connected to the end of the injection channel and communicates with it. The electrode layer includes at least two reactive electrodes, a reference electrode, and at least two connecting electrodes. The reactive electrodes and connecting electrodes share a reference electrode. Each reactive electrode is disposed on a corresponding shunt channel, and each shunt channel has a reference electrode. The reactive electrodes are located at the front end of the reference electrode. Each connecting electrode is connected to the corresponding reactive electrode and connected to a corresponding external port of the analyzer. This multifunctional electrochemical biosensor and analyte testing system has multiple functions and few electrodes, making it of significant clinical value.

Description

Technical Field

[0001] This invention relates to the field of sample testing sensor technology, and in particular to a multifunctional electrochemical biosensor and analyte testing system. Background Technology

[0002] An electrochemical biosensor is an analytical testing device that converts electron transfer generated by a biochemical reaction involving immobilized biological components or the biological organism itself on an electrode surface into a detectable electrical signal. Electrochemical biosensors were among the first types of biosensors to be developed, and due to their high sensitivity, ease of miniaturization, and ability to detect in complex sample systems, they have been widely used in healthcare, food industry, agriculture, and environmental monitoring.

[0003] Taking blood testing in the healthcare field as an example, clinical blood tests are generally divided into several categories, mainly checking whether various blood components are within acceptable limits, coagulation parameters, blood glucose, blood lipids, blood cholesterol, and various types of anemia. Specifically, taking blood glucose testing as an example, hospitals currently typically use electrochemical blood glucose test strips or general sensors to check blood glucose. Considering the current strain on medical resources, both large and small hospitals experience consistently high patient volumes. Since blood tests are a routine method for doctors to diagnose certain diseases, it is common to see patients waiting in line at hospitals for their blood drawn, and then having to wait several hours or even until the next day to receive their results. The inventor discovered that one reason for the slow turnaround time for blood test results is that clinical blood testing products, such as electrochemical blood glucose test strips, offer relatively limited testing capabilities, thus hindering the improvement of blood testing efficiency. Summary of the Invention

[0004] The purpose of this invention is to solve the technical problem that existing clinical blood testing products have limited testing items, resulting in low blood testing efficiency.

[0005] To address the aforementioned technical problems, embodiments of the present invention provide a multifunctional electrochemical biosensor, employing the following technical solution:

[0006] The multifunctional electrochemical biosensor includes an analyzer with at least two external ports and a sensor body connected to the analyzer. The sensor body includes a substrate layer, an electrode layer, and a spacer layer stacked sequentially.

[0007] The intermediate partition has an injection channel and at least two independent diversion channels. Each diversion channel is connected to the end of the injection channel and communicates with the injection channel. Each diversion channel has a reaction zone for the biochemical reaction of the analyte.

[0008] The electrode layer includes at least two reactive electrodes, one reference electrode, and at least two connecting electrodes, with all of the reactive electrodes and the connecting electrodes paired with one reference electrode.

[0009] Each of the reaction electrodes is disposed on a corresponding shunt channel, and each shunt channel is provided with a reference electrode; on each shunt channel, the reaction electrode is located at the front end of the reference electrode; each of the connecting electrodes is connected to the corresponding reaction electrode and connected to the corresponding external port of the analyzer.

[0010] In some embodiments, each of the reaction electrodes is disposed along the width direction of the corresponding shunt channel, and the width of each of the reaction electrodes is greater than the width of the corresponding shunt channel.

[0011] In some embodiments, the reference electrode includes at least two integrally designed first reference sub-electrodes, each reference sub-electrode being disposed along the width direction of the corresponding shunt channel and located at the rear end of the corresponding reaction electrode, and the width of each reference sub-electrode being greater than the width of the corresponding shunt channel.

[0012] In some embodiments, the length of each reference sub-electrode is greater than the length of the bottom of the corresponding shunt channel.

[0013] In some embodiments, the reference electrode further includes at least two second reference sub-electrodes, each of the second reference sub-electrodes being integrally designed with the first reference sub-electrode, and each of the second reference sub-electrodes corresponding one-to-one with each of the connecting electrodes.

[0014] In some embodiments, the connecting electrodes are arranged alternately.

[0015] In some embodiments, the multifunctional electrochemical biosensor further includes a capping layer, which is stacked with the septum and opposite to the electrode layer.

[0016] In some embodiments, each of the diversion channels is the same size and shape.

[0017] In some embodiments, the shunt channel, the reaction electrode, and the connecting electrode correspond one-to-one, and there are three of each. The number of the reference electrode is one.

[0018] To address the aforementioned technical problems, this invention also provides an analyte testing system, which employs the following technical solution: the analyte testing system includes the aforementioned multifunctional electrochemical biosensor.

[0019] Compared with the prior art, the multifunctional electrochemical biosensor and analyte testing system provided in this invention have the following advantages:

[0020] This multifunctional electrochemical biosensor features a septum designed to branch off at least two independent shunt channels from the sample injection channel. Each shunt channel contains a corresponding reaction electrode and at least two connecting electrodes, each corresponding to a reaction electrode. All reaction and connecting electrodes share a single reference electrode. This allows for the splitting of reactants into different shunt channels to induce different biochemical reactions with a single sample addition, enabling the simultaneous display of at least two biochemical indicators on the analyzer. Furthermore, the shared multifunctional circuitry simplifies the overall structure. In conclusion, this multifunctional electrochemical biosensor and analyte testing system offers numerous functions with few electrodes, facilitating broader clinical applications and possessing significant clinical value. Attached Figure Description

[0021] To more clearly illustrate the solutions in this invention, a brief introduction to the accompanying drawings used in the description of the embodiments will be provided below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without any creative effort. Wherein:

[0022] Figure 1 This is a schematic diagram of the overall design of a multifunctional electrochemical biosensor including a circuit structure in one embodiment of the present invention, wherein the top cover and analyzer have been removed.

[0023] Figure 2 yes Figure 1 A structurally exploded schematic diagram of a multifunctional electrochemical biosensor, showing the top cover layer.

[0024] Figure 3 yes Figure 1 A magnified view of part A of the multifunctional electrochemical biosensor, which mainly illustrates the structure of the reaction region of the sensor;

[0025] Figure 4 yes Figure 1 A magnified view of part B of the multifunctional electrochemical biosensor, which mainly shows the electrode layout of the sensor body and the analyzer.

[0026] The labels in the attached diagram are as follows:

[0027] 100. Multifunctional electrochemical biosensor; 10. Sensor body;

[0028] 1. Substrate layer;

[0029] 2. Electrode layer; 21. Reaction electrode; 22. Reference electrode; 221. First reference sub-electrode; 222. Second reference sub-electrode; 23. Connecting electrode;

[0030] 3. Intermediate layer; 31. Sample inlet channel; 32. Split channel; 33. Reaction zone;

[0031] 4. Top cover layer; 41. Trench. Detailed Implementation

[0032] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the invention. For example, terms such as “length,” “width,” “upper,” “lower,” “left,” “right,” “front,” “rear,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” and “outer” indicate orientations or positions based on the orientations or positions shown in the accompanying drawings and are for ease of description only, and should not be construed as limiting the technical solution.

[0033] The terms "comprising" and "having," and any variations thereof, in the specification, claims, and accompanying drawings of this invention are intended to cover non-exclusive inclusion; the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish different objects, not to describe a particular order. In the specification, claims, and accompanying drawings of this invention, when an element is referred to as "fixed to," "mounted to," "disposed of," or "connected to" another element, it may be directly or indirectly located on that other element. For example, when an element is referred to as "connected to" another element, it may be directly or indirectly connected to that other element.

[0034] Furthermore, the reference to "embodiment" herein means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of the invention. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0035] It should be noted that this multifunctional electrochemical biosensor 100 belongs to the dry electrochemical biosensor technology and is mainly used for the rapid in vitro detection of biochemical indicators in blood samples. Of course, it can also be used to detect other suitable analyte samples, such as liquid samples like urine. Taking the detection of blood samples as an example, this multifunctional electrochemical biosensor 100 can be operated and used in medical institutions, by family doctors, or by patients themselves.

[0036] This invention provides a multifunctional electrochemical biosensor 100, such as... Figure 1 As shown, the multifunctional electrochemical biosensor 100 includes an analyzer (not shown) and a sensor body 10. The analyzer has at least two external ports (not shown), and the sensor body 10 is externally connected to the analyzer. It should be noted that the analyzer is designed based on the function of the sensor body 10. Specifically, each external port in the analyzer is electrically connected to the corresponding connecting electrodes 23 and reference electrodes 22 (specifically, the second reference sub-electrode 222 described below) of the sensor body 10. Thus, the electrochemical signal detected by the sensor body 10 can be displayed on the analyzer's display using an analyzer conversion method, thereby enabling the detection of multiple reactants.

[0037] In embodiments of the present invention, such as Figure 1 and Figure 2 As shown, structurally, the sensor body 10 includes a substrate layer 1, an electrode layer 2, and a partition layer 3 stacked sequentially. Furthermore, in this embodiment of the invention, the multifunctional electrochemical biosensor 100 also includes a top cover layer 4, which is stacked with the partition layer 3 and opposite to the electrode layer 2; that is, the top cover layer 4 is disposed on the top surface of the partition layer 3. It can be understood that the substrate layer 1, electrode layer 2, partition layer 3, and top cover layer 4 are stacked sequentially. In this embodiment, the substrate layer 1 can serve as a supporting substrate, the electrode layer 2 can serve as a circuit design layer, and the partition layer 3 can serve as a channel design layer. Through the stacked design between the top cover layer 4 and the partition layer 3, a complete channel structure for reactant injection and reaction can be ultimately formed.

[0038] Specifically, in this embodiment, the substrate layer 1 can be made of PET material, or other suitable materials. The circuit layer is set on the substrate layer 1 by screen printing, or other suitable methods can be used to set it on the substrate layer 1. In addition, specifically in this embodiment, to simplify the structure, the sensor body 10 of the multifunctional electrochemical biosensor 100 can be sheet-shaped, that is, its appearance can be similar to that of a conventional electrochemical blood glucose test strip.

[0039] In embodiments of the present invention, such as Figures 1 to 3As shown, in terms of structural design, the intermediate partition 3 has a sample injection channel 31 and at least two diversion channels 32. Each diversion channel 32 is connected to the end of the sample injection channel 31 and communicates with it. To ensure that the detection results are not correlated, each diversion channel 32 is independent of each other. In addition, each diversion channel 32 has a reaction zone 33 for the biochemical reaction of the analyte. In this way, the reactants entering from the inlet of the sample injection channel 31 can be diverted into the diversion channels 32 and undergo biochemical reactions independently. This allows for the convenient and rapid detection of multiple biochemical indicators of the same reactant with a single sample addition, i.e., the detection of multiple items.

[0040] It should be noted that, to achieve the biochemical reaction, the reaction zone 33 of each diversion channel 32 is coated with biochemically active substances. Typically, to detect multiple biochemical indicators of the same reactant simultaneously, the composition of the biochemically active substances in each diversion channel 32 is different. In this way, characteristic components of the reactant, such as those in blood, can undergo biochemical reactions with each biochemically active substance, thereby obtaining different biochemical results. Of course, in practice, they can also be the same. Generally, these biochemically active substances can be proteins, enzymes, or other active substances.

[0041] In embodiments of the present invention, such as Figure 1 , Figure 2 and Figure 4 As shown, in the circuit design, electrode layer 2 includes at least two reaction electrodes 21, one reference electrode 22, and at least two connecting electrodes 23. All reaction electrodes 21 and all connecting electrodes 23 are paired with one reference electrode 22. That is, all reaction electrodes 21 share one reference electrode 22, all connecting electrodes 23 share one reference electrode 22, and so on. In other words, only one reference electrode 22 is provided on the sensor body 10, and the detection of different parameters of the same reactant shares one reference electrode 22. Thus, in existing designs, detecting each parameter typically involves functions such as detection, activation, and full-blood detection, which generally require at least four electrodes. Therefore, detecting three parameters would require twelve electrodes. Clearly, this shared electrode structure in this embodiment of the invention can significantly reduce the number of electrodes, thereby simplifying the overall circuit structure.

[0042] In embodiments of the present invention, such as Figure 1 and Figure 3As shown, to achieve the biochemical reaction, each reaction electrode 21 is disposed on a corresponding flow channel 32, and each flow channel 32 is provided with a reference electrode 22. Specifically, on each flow channel 32, the reaction electrode 21 is located in front of the reference electrode 22; that is, after the reactants are diverted from the injection channel 31 into the corresponding flow channel 32, the reactants must first pass through the corresponding reaction electrode 21 and then through the reference electrode 22. Correspondingly, to facilitate the transfer of the biochemical reaction results to the analyzer, each connecting electrode 23 is connected to the corresponding reaction electrode 21 and connected to the corresponding external port of the analyzer (not shown in the figure).

[0043] Understandably, the shunt channel 32, the reaction electrode 21, and the connecting electrode 23 correspond one-to-one, and each reaction electrode 21 and the reference electrode 22 together detect a parameter. Therefore, the number of shunt channels 32, reaction electrodes 21, and connecting electrodes 23 is equal to the number of parameters or items that the multifunctional electrochemical biosensor 100 can detect.

[0044] Specifically, in this embodiment, there are three shunt channels 32, three reaction electrodes 21, and three connecting electrodes 23, and one reference electrode 22. Taking blood as the reactant, in this embodiment, the multifunctional electrochemical biosensor 100 can be used to detect three indicators: blood glucose, blood lipids, and blood cholesterol. Of course, in practice, other functional indicators can also be designed according to different needs, such as simultaneously detecting four blood lipid parameters, liver function, and kidney function.

[0045] For ease of explanation, let's take an example that can detect three parameters, such as... Figure 1 and Figure 3 As shown, the injection channel 31 and each diversion channel 32 are numbered 1, 2, 3 and 4 respectively. Channel 1 is the injection channel 31. In this way, after the reactants are injected from channel 1, they can be diverted into channels 2, 3 and 4. Corresponding to each shunt channel 32, each reaction electrode 21 is electrode a, b, and c, and electrodes a, b, and c together correspond to a reference electrode d (i.e., the first reference sub-electrode 221 described below). Additionally, each connection electrode 23 connected to the analyzer is electrode a1, b1, and c1. Thus, in shunt channel 32, the reactant passes through reaction electrode a and reference electrode d sequentially, and then the corresponding reaction signal is transmitted to the analyzer through the corresponding external port via connection electrode a1, thereby detecting one parameter. In shunt channel 32, the reactant passes through reaction electrode b and reference electrode d sequentially, and then the corresponding reaction signal is transmitted to the analyzer through the corresponding external port via connection electrode b1, thereby detecting another parameter. In shunt channel 32, the reactant passes through reaction electrode c and reference electrode d sequentially, and then the corresponding reaction signal is transmitted to the analyzer through the corresponding external port via connection electrode c1, thereby detecting yet another parameter.

[0046] In summary, compared with existing technologies, the multifunctional electrochemical biosensor 100 has at least the following beneficial effects: The multifunctional electrochemical biosensor 100 designs the septum 3 to branch off at least two independent shunt channels 32 from the sample injection channel 31, and sets a corresponding reaction electrode 21 in each shunt channel 32, and sets at least two connecting electrodes 23, with each connecting electrode 23 corresponding one-to-one with the reaction electrode 21. Furthermore, all reaction electrodes 21 and connecting electrodes 23 share a single reference electrode 22. This allows reactants to be diverted to different shunt channels 32 for different biochemical reactions with a single sample addition, thereby displaying at least two biochemical indicators simultaneously in the analyzer. The shared multifunctional circuitry simplifies the overall structure. In conclusion, the multifunctional electrochemical biosensor 100 has multiple functions and fewer electrodes, which is beneficial for expanding its clinical application scope and has significant clinical value.

[0047] To enable those skilled in the art to better understand the present invention, the following will be described in conjunction with the appendix. Figures 1 to 4 The technical solutions in the embodiments of the present invention will be clearly and completely described.

[0048] In some embodiments, such as Figure 1 and Figure 3 As shown, each reaction electrode 21 is arranged along the width direction of its corresponding flow channel 32, and the width of each reaction electrode 21 is greater than the width of its corresponding flow channel 32. This ensures that printing errors will not affect the area of ​​each reaction electrode 21.

[0049] In some embodiments, such as Figure 1 and Figure 3 As shown, the reference electrode 22 includes at least two integrally designed first reference sub-electrodes 221, wherein each reference sub-electrode is arranged along the width direction of the corresponding shunt channel 32 and located at the rear end of the corresponding reaction electrode 21, and the width of each reference sub-electrode is greater than the width of the corresponding shunt channel 32, so as to eliminate the influence of printing errors.

[0050] In some embodiments, such as Figure 1 and Figure 3 As shown, the length of each reference sub-electrode is greater than the length of the bottom of the corresponding shunt channel 32. In this way, the reference electrode 22 can simultaneously detect whether the sample injection volume is sufficient, that is, it can perform full-blood detection.

[0051] In some embodiments, such as Figure 1 and Figure 4As shown, to facilitate the transfer of different biochemical reaction results to the analyzer, the reference electrode 22 further includes at least two second reference sub-electrodes 222. Each second reference sub-electrode 222 is integrally designed with the first reference sub-electrode 221, and each second reference sub-electrode 222 corresponds one-to-one with each connecting electrode 23. It can be understood that each second reference sub-electrode 222 and each first reference sub-electrode 221 actually belong to the same reference electrode 22. Furthermore, in this embodiment, any two second reference sub-electrodes 222 can serve as the start-up electrode for the analyzer, thus further reducing the number of electrodes.

[0052] Specifically in this embodiment, the three second reference sub-electrodes 222 are d1, d2 and d3 respectively. Of course, in reality, they are the same reference electrode 22 as the reference electrode d.

[0053] In some embodiments, such as Figure 1 and Figure 4 As shown, the connecting electrodes 23, such as a1, b1 and c1, are arranged in an alternating manner, which can prevent electrodes with different functions from making accidental contact or short circuits.

[0054] In some embodiments, such as Figure 1 and Figure 3 As shown, all the diversion channels 32 are the same size and shape. This facilitates equal-volume sample testing. Of course, in practice, the size and shape of each diversion channel 32 can be different, depending on the actual needs. It should be noted that a groove 41 is formed on the side of the upper cover layer 4 near the middle partition layer 3. This facilitates the adaptation with the sample inlet channel 31 and diversion channel 32 formed on the middle partition layer 3 to form a complete channel.

[0055] It should be noted that, in reality, the multifunctional electrochemical biosensor 100 may also include bio-identification elements, signal converters, and other components that ensure the sensor can achieve complete detection. However, since the structure of these components can adopt existing structures, and the focus of this invention is not on these, they will not be described in detail here.

[0056] As can be understood from the above, specifically in this embodiment, the multifunctional electrochemical biosensor 100 has the following characteristics: 1) Multifunctional, capable of detecting multiple biochemical indicators at once; 2) The entire system uses only one reference electrode 22. By sharing electrodes, the number of electrodes used is reduced, which not only simplifies the overall structure and reduces manufacturing costs, but also allows the reference electrode 22 to be used as a shared reference electrode 22, as the start-up electrode for starting the analyzer, and as a full-blood detection electrode for detecting the sample injection volume.

[0057] Based on the aforementioned multifunctional electrochemical biosensor 100, this embodiment of the invention also provides an analyte testing system, wherein the analyte testing system includes the aforementioned multifunctional electrochemical biosensor 100. It should be noted that the analyte testing system can be used to detect various functional indicators of blood, and can also detect various indicators of other fluids such as urine.

[0058] In summary, compared with existing technologies, this analyte testing system has at least the following advantages: by employing the aforementioned multifunctional electrochemical biosensor 100, the analyte testing system is versatile, simple in structure, and low in manufacturing cost, which facilitates the expansion of its clinical applications and has significant clinical value.

[0059] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of the claims of the present invention.

Claims

1. A multifunctional electrochemical biosensor, characterized in that, The multifunctional electrochemical biosensor includes an analyzer with at least two external ports and a sensor body connected to the analyzer. The sensor body includes a substrate layer, an electrode layer, and a spacer layer stacked sequentially. The intermediate partition has an injection channel and at least two independent diversion channels. Each diversion channel is connected to the end of the injection channel and communicates with the injection channel. Each diversion channel has a reaction zone for the biochemical reaction of the analyte. The electrode layer includes at least two reactive electrodes, one reference electrode, and at least two connecting electrodes, with all of the reactive electrodes and the connecting electrodes paired with one reference electrode. Each of the aforementioned reaction electrodes is disposed on a corresponding shunt channel, and each of the aforementioned shunt channels is provided with a reference electrode; on each of the aforementioned shunt channels, the reaction electrode is located at the front end of the reference electrode; each of the aforementioned connecting electrodes is connected to the corresponding reaction electrode and is connected to the corresponding external port of the analyzer; The reference electrode includes at least two integrally designed first reference sub-electrodes and at least two second reference sub-electrodes, each of the second reference sub-electrodes being integrally designed with the first reference sub-electrodes, and any two second reference sub-electrodes can serve as a start-up electrode to start the analyzer. The connecting electrodes are arranged in an alternating pattern.

2. The multifunctional electrochemical biosensor according to claim 1, characterized in that, Each of the reaction electrodes is arranged along the width direction of the corresponding shunt channel, and the width of each reaction electrode is greater than the width of the corresponding shunt channel.

3. The multifunctional electrochemical biosensor according to claim 1, characterized in that, Each of the reference sub-electrodes is disposed along the width direction of the corresponding shunt channel and located at the rear end of the corresponding reaction electrode, and the width of each of the reference sub-electrodes is greater than the width of the corresponding shunt channel.

4. The multifunctional electrochemical biosensor according to claim 3, characterized in that, The length of each of the reference sub-electrodes is greater than the length of the bottom of the corresponding shunt channel.

5. The multifunctional electrochemical biosensor according to claim 3, characterized in that, Each of the second reference sub-electrodes corresponds one-to-one with each of the connecting electrodes.

6. The multifunctional electrochemical biosensor according to claim 1, characterized in that, The multifunctional electrochemical biosensor also includes a top cover layer, which is stacked with the middle septum and is opposite to the electrode layer.

7. The multifunctional electrochemical biosensor according to any one of claims 1 to 6, characterized in that, All of the aforementioned diversion channels are the same size and shape.

8. The multifunctional electrochemical biosensor according to any one of claims 1 to 6, characterized in that, The shunt channel, the reaction electrode, and the connecting electrode are in one-to-one correspondence, and there are three of each. The reference electrode is one.

9. An analyte testing system, characterized in that, The analyte testing system includes the multifunctional electrochemical biosensor according to any one of claims 1 to 8.

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