A biosensor and a method for improving its accuracy

By designing the collection pipeline and piston structure in the biosensor, ensuring sufficient blood flow into the reaction layer, solving the problem of insufficient blood volume caused by irregular operation of patients with hyperglycemia, improving the accuracy and safety of blood sugar detection, and reducing test strip waste.

CN114839249BActive Publication Date: 2024-12-06HEFEI YIZHIGU INTELLECTUAL PROPERTY OPERATION CO LTD
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Patent Information

Application Number
CN202210640250.6
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-06-07
Publication Date
2024-12-06
Estimated Expiration
2042-06-07

AI Technical Summary

Technical Problem

Patients with hyperglycemia operate incorrectly when monitoring their blood sugar on their own, resulting in the inability to absorb enough blood, insufficient blood volume, and the deviation rate is as high as 39% to 85%. The blood glucose meter is reported, causing waste and inaccurate detection.

Method used

A biosensor is designed, including substrate, reaction layer, electrode sheet, acquisition pipe and piston. Through the sealed connection between the piston and the acquisition pipe and the protective cover structure, ensuring sufficient blood enters the reaction layer, reducing waste, and improving detection accuracy. And reduce the impact of temperature and humidity through alcohol disinfection and transparent protective cover.

Benefits of technology

By observing the blood volume of the collection pipeline, determine whether it is sufficient, ensure the accuracy of blood sugar detection, reduce test strip waste, improve the accuracy and safety of blood sugar detection, and reduce the false alarm rate.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention belongs to the technical field of biosensors, and specifically is a biosensor and a method for improving its accuracy, comprising: a substrate, a reaction layer, an electrode sheet, a collection pipe, and a piston; the piston is slidably and sealingly connected in the collection pipe, and a sliding rod is fixedly connected to one side of the piston. In order to solve the problem that patients with high blood sugar will measure their blood sugar by themselves, but the operation of these patients is sometimes not standardized, resulting in the inability of the test paper to absorb sufficient blood, insufficient blood volume, and a deviation rate of up to 39% to 85%. Insufficient blood volume sometimes causes a blood glucose meter to report an error, requiring blood sampling and measurement again, and the test paper is a disposable item, thus causing a waste problem; the present invention collects blood by arranging a piston and a collection pipe, and determines whether the blood collection is sufficient by observing the blood volume in the collection pipe, ensuring that sufficient blood volume enters the reaction layer, ensuring the accuracy of blood sugar detection, and can replenish blood when the blood volume is insufficient, without wasting test paper.
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Description

Technical Field

[0001] The present invention belongs to the technical field of biosensors, in particular to a biosensor and a method for improving its accuracy. Background Art

[0002] A biosensor is an instrument that is sensitive to biological substances and converts their concentration into electrical signals for detection. It is an analytical tool or system composed of immobilized biosensitive materials as recognition elements (including enzymes, antibodies, antigens, microorganisms, cells, tissues, nucleic acids and other biologically active substances), appropriate physical and chemical transducers (such as oxygen electrodes, photosensitive tubes, field effect transistors, piezoelectric crystals, etc.) and signal amplification devices. Biosensors have the functions of receivers and converters.

[0003] When patients with high blood sugar monitor their blood sugar, they also need to detect components such as cells, microorganisms and enzymes in their bodies. Most of them use blood glucose meters to monitor their blood sugar. Blood glucose meters measure blood sugar by measuring the amount of current generated by the reaction between glucose in the blood and glucose oxidase or glucose dehydrogenase in the test paper. When sampling blood, test paper is often used as a sampling method.

[0004] Test strips are a type of biosensor. In order to facilitate blood sugar monitoring, most patients with high blood sugar will bring their own portable blood glucose meters to monitor their blood sugar. However, these patients' operations are sometimes not standardized, resulting in the test strips being unable to absorb enough blood, resulting in insufficient blood volume and a deviation rate as high as 39% to 85%. Insufficient blood volume may sometimes cause the blood glucose meter to report an error, requiring blood sampling and measurement again. Test strips are disposable items, thus causing waste.

[0005] In view of this, the present invention proposes a biosensor and a method for improving its accuracy to solve the above technical problems. Summary of the invention

[0006] In order to address the deficiencies in the prior art, the present invention proposes a biosensor and a method for improving its accuracy; it solves the problem that patients with high blood sugar will measure their blood sugar by themselves, but these patients' operations are sometimes not standardized, resulting in the test paper being unable to absorb sufficient blood, insufficient blood volume, and a deviation rate as high as 39% to 85%. Insufficient blood volume may sometimes cause the blood glucose meter to report an error, requiring blood sampling and measurement again, and the test paper is a disposable item, thus causing waste.

[0007] The technical solution adopted by the present invention to solve the technical problem is: a biosensor described in the present invention comprises:

[0008] substrate;

[0009] A reaction layer, wherein the reaction layer is fixed inside the substrate;

[0010] An electrode sheet, the electrode sheet is fixedly connected to one end of the outer side of the substrate, and the electrode sheet is electrically connected to the reaction layer;

[0011] A collection channel is provided at one end of the substrate away from the electrode sheet, and the collection channel is connected to the reaction layer; the collection channel is used for collecting blood.

[0012] A piston is slidably and sealingly connected in the collection pipeline, and a sliding rod is fixedly connected to one side of the piston.

[0013] Preferably, a blood collection needle is fixedly connected to the piston on a side away from the sliding rod.

[0014] Preferably, a rubber ring or a seal for increasing friction is provided on the outer side of the piston.

[0015] Preferably, a protective cover is fixedly connected to one end of the substrate close to the liquid inlet of the collection pipeline.

[0016] Preferably, the protective cover is made of a transparent material, so that the blood collection situation can be easily observed through the protective cover.

[0017] Preferably, the protective cover is trumpet-shaped, the smaller end of the protective cover is fixedly connected to the substrate, and the protective cover is made of flexible material.

[0018] Preferably, the larger end of the protective cover is fixedly connected with aluminum foil.

[0019] Preferably, the substrate is fixedly connected with a cover plate on the collection pipe, and the cover plate is made of a transparent material.

[0020] Preferably, the cover plate is provided with scale lines and means that can be used as a measurement standard.

[0021] The method for improving the accuracy of a biosensor described in the present invention is applicable to the above-mentioned biosensor, and the steps of the method are as follows:

[0022] S1. First, wipe and disinfect the fingertips where blood is to be drawn with alcohol;

[0023] S2. After the alcohol in S1 is dried, pinch the substrate with your hands, peel off the aluminum foil, align the protective cover with the puncture site, slide the slide bar, puncture the finger, slide the slide bar in the opposite direction, and suck the fingertip blood at the puncture site into the collection tube;

[0024] S3, after a sufficient amount of blood is collected in the collection tube in S2, the electrode sheet of the substrate is inserted into the blood glucose meter, and the blood glucose meter detects the current change of the reaction layer and reads and displays the blood glucose value;

[0025] S4, the blood glucose meter records the blood glucose value measured in S3, determines the patient's state as fasting, 1 hour after a meal, 2 hours after a meal, or 3 hours after a meal during measurement, and stores the measured blood glucose value in a corresponding storage space;

[0026] S5. Record the fasting data measured every day in S4 as X1, X2, ..., X n , compare the X0 measured on an empty stomach on that day with weekly, monthly, quarterly and annual cycles, and calculate the difference ΔX=|X0-X n |, and obtain the difference ΔX with weekly, monthly, quarterly and annual periods respectively w , ΔX m , ΔX q , ΔX y ;

[0027] S6. Record the data measured one hour after each meal in S4 as A1, A2, ..., A n ; The data measured 2 hours after each meal are recorded as B1, B2, ..., B n ; The data measured 3 hours after each meal are recorded as C1, C2, ..., C n ; And draw the postprandial blood glucose curve F1(x), F2(x), ... Fn(x), according to the X0, A0, B0, C0 measured on the day, and draw the postprandial blood glucose curve F0(x), and compare them with weekly, monthly, quarterly and annual cycles, and calculate the deviation rate Δ The deviation rate ΔY with weekly, monthly, quarterly and annual periods is obtained respectively w , ΔY m , ΔY q , ΔY y ;

[0028] S7. Compare the data ΔX or ΔY in S5 and S6 to see if they exceed the threshold. If the threshold is exceeded, the blood glucose meter will give an alarm to remind the patient to remeasure the blood glucose for calibration. If the blood glucose still deviates greatly, the abnormal value will be recorded to remind the patient to control blood glucose and seek medical treatment in time.

[0029] The beneficial effects of the present invention are as follows:

[0030] 1. The biosensor and the method for improving its accuracy described in the present invention collect blood by setting a piston and a collection pipe, and judge whether the blood collection is sufficient by observing the blood volume in the collection pipe, so as to ensure that sufficient blood enters the reaction layer and the accuracy of blood glucose detection. When the blood volume is insufficient, blood can be supplemented without wasting test paper.

[0031] 2. The biosensor and the method for improving its accuracy described in the present invention improve the sealing performance between the piston and the collection tube by sleeved a rubber ring on the outside of the piston. When drawing blood, the good sealing performance between the piston and the collection tube ensures that the piston has sufficient pressure when sliding in the collection tube, thereby facilitating the extraction of blood into the collection tube. The rubber ring increases the friction between the piston and the collection tube, making it easier to control the sliding speed when sliding.

[0032] 3. The biosensor and the method for improving its accuracy described in the present invention provide a protective cover. When blood is collected, after the finger is disinfected, the protective cover is covered over the blood collection site, and then the slide bar is slid to drive the blood collection needle to pierce the finger to perform the blood collection operation. At this time, the blood is isolated from the outside air, thereby reducing the influence of temperature and humidity on blood sugar detection. In addition, for the test paper using glucose oxidase, it is not easily affected by oxygen in the air, thereby improving the accuracy of blood sugar detection.

[0033] 4. A biosensor and a method for improving the accuracy thereof described in the present invention comprises the following steps: providing aluminum foil, which is fixedly connected to a protective cover by heat sealing or gluing. Before use, the aluminum foil seals the protective cover to isolate the blood collection needle from the air, thereby effectively protecting the test paper. When in use, the aluminum foil is peeled off before blood collection, thereby protecting the blood collection needle from oxidation and causing tetanus during blood collection, protecting the rubber ring from oxidation and aging, thereby ensuring sealing, protecting the reaction layer, and ensuring the accuracy of detection. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The present invention will be further described below in conjunction with the accompanying drawings.

[0035] Figure 1 is a stereogram of the biosensor of the present invention;

[0036] Figure 2 is a three-dimensional diagram of the cover plate of the present invention when it is hidden;

[0037] Figure 3 It is the internal structure diagram of the present invention;

[0038] Figure 4 yes Figure 3 A partial enlarged view of the middle part;

[0039] Figure 5 It is a diagram of the method steps of the present invention;

[0040] Figure 6 It is a postprandial blood sugar curve of person No. 1 recorded by the present invention;

[0041] Figure 7 It is the blood sugar curve of person No. 2 after meal recorded by the present invention;

[0042] Figure 8It is the postprandial blood sugar curve of person No. 3 recorded by the present invention;

[0043] Fig. 9 It is the blood sugar curve of person No. 4 after meal recorded by the present invention;

[0044] Fig.10 It is the blood sugar curve of person No. 5 after meal recorded by the present invention;

[0045] Fig.11 It is the blood sugar curve of person No. 6 after meal recorded by the present invention;

[0046] In the figure: 1. substrate; 11. reaction layer; 12. electrode sheet; 13. collection pipe; 14. liquid inlet; 2. piston; 21. slide rod; 22. rubber ring; 3. blood collection needle; 4. protective cover; 5. aluminum foil; 6. cover plate; 61. scale line. DETAILED DESCRIPTION

[0047] In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the present invention is further explained below in conjunction with specific implementation methods.

[0048] The embodiment of the present invention provides a biosensor and a method for improving its accuracy, which solves the technical problem that patients with high blood sugar may measure their blood sugar by themselves, but these patients' operation is sometimes not standardized, resulting in the test strip being unable to absorb a sufficient amount of blood, insufficient blood volume, and a deviation rate as high as 39% to 85%. Insufficient blood volume may sometimes cause the blood glucose meter to report an error, requiring blood sampling and measurement again, and the test strip is a disposable item, thus causing waste.

[0049] The technical solution in the embodiment of the present invention is to solve the above-mentioned technical problems. The overall idea is as follows: blood is collected by setting a piston 2 and a collection pipe 13, and the amount of blood collected is judged by observing the blood volume in the collection pipe 13 to ensure that sufficient blood enters the reaction layer 11, thereby ensuring the accuracy of blood glucose detection, and blood can be supplemented when the blood volume is insufficient, without wasting test paper.

[0050] like Figures 1 to 11 As shown, a biosensor according to the present invention comprises:

[0051] Substrate 1;

[0052] A reaction layer 11, wherein the reaction layer 11 is fixed inside the substrate 1;

[0053] An electrode sheet 12, wherein the electrode sheet 12 is fixedly connected to one end of the outer side of the substrate 1, and the electrode sheet 12 is electrically connected to the reaction layer 11;

[0054] A collection pipe 13, the collection pipe 13 is opened at one end of the substrate 1 away from the electrode sheet 12, and the collection pipe 13 is connected to the reaction layer 11;

[0055] A piston 2, wherein the piston 2 is slidably and sealingly connected in the collection pipe 13, and a sliding rod 21 is fixedly connected to one side of the piston 2;

[0056] Patients with high blood sugar will measure their blood sugar by themselves, but these patients' operation is sometimes not standardized, resulting in the test strips being unable to absorb enough blood, insufficient blood volume, and a deviation rate as high as 39% to 85%. Insufficient blood volume sometimes causes the blood glucose meter to report an error, requiring blood sampling and measurement again. The test strips are disposable items, thus causing waste;

[0057] In the present invention, by setting a piston 2, when measuring blood sugar, first wipe and disinfect the fingertips with alcohol, wait for the alcohol to dry, pierce the fingertips with a sharp object, pinch the substrate 1 with the hand, align the collection pipe 13 with the puncture site, slide the slide bar 21 with one finger, so that the piston 2 slides in the collection pipe 13, and the fingertip blood at the puncture site is sucked into the collection pipe 13. At this time, the piston 2 blocks the blood from entering the reaction layer 11. When the slide bar 21 is pulled a certain distance, the blood volume is observed from the liquid inlet 14 of the collection pipe 13. If the blood volume at the liquid inlet 14 is full, the blood collection volume is sufficient. If the blood volume at the liquid inlet 14 is insufficient, the blood collection volume is sufficient. , the blood collection amount is insufficient, at this time, the slide bar 21 is slid in the opposite direction to push the blood to the liquid inlet 14, and the blood is continuously drawn until the blood volume in the collection pipe 13 is sufficient. After the blood volume in the collection pipe 13 is sufficient, the slide bar 21 is continuously slid, so that the piston 2 continues to slide to the end of the collection pipe 13 away from the liquid inlet 14. At this time, the collection pipe 13 is connected with the reaction layer 11. Under the action of the capillary effect, the blood in the collection pipe 13 enters the reaction layer 11 and reacts with the enzyme in the reaction layer 11. The electrode sheet 12 is inserted into the blood glucose meter, and the blood glucose meter detects the current change of the reaction layer 11 and displays the blood glucose value;

[0058] In the present invention, blood is collected by setting a piston 2 and a collection pipe 13. The amount of blood in the collection pipe 13 is observed to determine whether the blood is sufficient, ensuring that sufficient blood enters the reaction layer 11, thereby ensuring the accuracy of blood glucose detection. When the blood volume is insufficient, blood can be supplemented without replacing the biosensor, thereby reducing waste.

[0059] like Figure 3 and Figure 4 As shown, the piston 2 is fixedly connected with a blood collection needle 3 on the side away from the slide rod 21;

[0060] By setting the blood collection needle 3, in the initial state, the piston 2 is in the deep of the collection pipe 13. At this time, the piston 2 is away from the liquid inlet 14 of the collection pipe 13, and the blood collection needle 3 is hidden in the collection pipe 13. After the finger is disinfected, the slide bar 21 is slid to push the piston 2 to move outward, so that the blood collection needle 3 is exposed and pierces the disinfected collection to pierce the finger skin to make blood flow out. Then the slide bar 21 is slid to make the piston 2 move into the collection pipe 13 to perform the blood collection operation. At this time, the blood collection needle 3 is hidden in the collection pipe 13. By integrating the blood collection needle 3 on the piston 2 and hiding the blood collection needle 3 in the collection pipe 13, it is easy to use, and after use, it is not easy to hurt people and blood infection is not easy to occur, thereby improving the safety of use.

[0061] like Figure 4 As shown, a rubber ring 22 is sleeved on the outer side of the piston 2;

[0062] By sleeved a rubber ring 22 on the outside of the piston 2, the sealing performance between the piston 2 and the collection pipe 13 is improved. When blood is collected, the good sealing performance between the piston 2 and the collection pipe 13 makes it possible for the piston 2 to have sufficient pressure when sliding on the collection pipe 13, thereby facilitating the extraction of blood into the collection pipe 13. The rubber ring 22 increases the friction between the piston 2 and the collection pipe 13, making it easy to control the sliding speed when sliding to prevent sliding too fast, making it difficult for the blood collection needle 3 to penetrate too deep and causing greater damage to the fingers, and making it difficult for the piston 2 to move too fast when blood is collected so that the collection pipe 13 is connected to the reaction layer 11, thereby facilitating the observation of the amount of blood in the collection pipe 13.

[0063] like Figures 1 to 3 As shown, the substrate 1 is fixedly connected with a protective cover 4 at one end close to the liquid inlet 14 of the collection pipe 13;

[0064] By setting the protective cover 4, when drawing blood, after the finger is disinfected, the protective cover 4 is covered on the blood drawing site, and then the slide bar 21 is slid to drive the blood drawing needle 3 to pierce the finger to perform the blood drawing operation. At this time, the blood is isolated from the outside air, thereby reducing the influence of temperature and humidity on blood sugar detection. In addition, for the test paper using glucose oxidase, it is not easily affected by oxygen in the air, thereby improving the accuracy of blood sugar detection.

[0065] like Figures 1 to 3 As shown, the protective cover 4 is made of transparent material;

[0066] By using transparent material to make the anti-slip cover, it is easy to observe the puncture status of the finger and the amount of bleeding, ensuring that a sufficient amount of blood can be collected and the accuracy of the test is guaranteed. The transparent material can be plastic, resin, etc.

[0067] The protective cover 4 is trumpet-shaped, the smaller end of the protective cover 4 is fixedly connected to the substrate 1, and the protective cover 4 is made of flexible material;

[0068] By setting the protective cover 4 to be trumpet-shaped and made of flexible material, it is convenient to adsorb the protective cover 4 on the finger during blood collection, further isolating the air and strengthening the connection between the test paper and the finger, making it less likely to be misaligned, thereby ensuring the stability of the blood collection process and facilitating operation and use.

[0069] like Figure 3 As shown, the larger end of the protective cover 4 is fixedly connected with an aluminum foil 5;

[0070] By setting the aluminum foil 5, the aluminum foil 5 is fixedly connected to the protective cover 4 by heat sealing or gluing. Before use, the aluminum foil 5 seals the protective cover 4, so that the blood collection needle 3 and the like are isolated from the air, and the test paper is effectively protected. When in use, the aluminum foil 5 is peeled off and then blood is collected, thereby protecting the blood collection needle 3 from oxidation and tetanus during blood collection, protecting the rubber ring 22 from oxidation and aging, ensuring the sealing performance, protecting the reaction layer 11, and ensuring the accuracy of the detection.

[0071] like Figure 1 , 3 As shown in FIG. 4 , the substrate 1 is fixedly connected to a cover plate 6 on the collection pipe 13 , and the cover plate 6 is made of a transparent material;

[0072] The cover plate 6 is provided with scale lines 61;

[0073] By providing a transparent cover 6, it is convenient to observe the amount of blood in the collection pipe 13, and a scale line 61 is provided on the cover 6, so as to determine the amount of blood in the collection pipe 13 more accurately, thereby determining the blood collection amount, ensuring that a sufficient amount of blood can be collected, and the blood condition in the collection pipe 13 can be observed. When there are many bubbles, the blood is pushed out and the blood is collected again to ensure the accuracy of blood collection. When pricking the finger, the depth of needle insertion can be controlled to reduce excessive bleeding caused by too deep needle insertion and insufficient blood collection caused by too shallow needle insertion, so that the blood collection needle 3 can be inserted into a more appropriate depth to ensure the blood collection amount and reduce the damage to the finger.

[0074] The method for improving the accuracy of a biosensor described in the present invention is applicable to the above-mentioned biosensor, and the steps of the method are as follows:

[0075] S1. First, wipe and disinfect the fingertips where blood is to be drawn with alcohol;

[0076] S2. After the alcohol in S1 is dried, pinch the substrate 1 with your hands, peel off the aluminum foil 5, align the protective cover 4 with the puncture site, slide the slide bar 21, puncture the finger, slide the slide bar 21 in the opposite direction, and suck the fingertip blood at the puncture site into the collection pipe 13;

[0077] S3, after a sufficient amount of blood is collected in the collection tube in S2, the electrode sheet 12 of the substrate 1 is inserted into the blood glucose meter, and the blood glucose meter detects the current change of the reaction layer 11 and reads and displays the blood glucose value;

[0078] S4, the blood glucose meter records the blood glucose value measured in S3, determines the patient's state as fasting, 1 hour after a meal, 2 hours after a meal, or 3 hours after a meal during measurement, and stores the measured blood glucose value in a corresponding storage space;

[0079] S5. Record the fasting data measured every day in S4 as X1, X2, ..., X n , compare the X0 measured on an empty stomach on that day with weekly, monthly, quarterly and annual cycles, and calculate the difference ΔX=|X0-X n |, and obtain the difference ΔX with weekly, monthly, quarterly and annual periods respectively w , ΔX m , ΔX q , ΔX y ;

[0080] S6. Record the data measured one hour after each meal in S4 as A1, A2, ..., A n ; The data measured 2 hours after each meal are recorded as B1, B2, ..., B n ; The data measured 3 hours after each meal are recorded as C1, C2, ..., C n ; And draw the postprandial blood glucose curve F1(x), F2(x), ... Fn(x), according to the X0, A0, B0, C0 measured on the day, and draw the postprandial blood glucose curve F0(x), and compare them with weekly, monthly, quarterly and annual cycles, and calculate the deviation rate Δ The deviation rate ΔY with weekly, monthly, quarterly and annual periods is obtained respectively w , ΔY m , ΔY q , ΔY y ;

[0081] S7. Compare the data ΔX or ΔY in S5 and S6 to see if they exceed the threshold. If the threshold is exceeded, the blood glucose meter will give an alarm to remind the patient to remeasure the blood glucose for calibration. If the blood glucose still deviates greatly, the abnormal value will be recorded to remind the patient to control blood glucose and seek medical treatment in time.

[0082] The following is the data recorded in actual use of the present invention. The blood glucose measurement results of 6 people are selected and numbered 1, 2, 3, 4, 5 and 6 respectively, where 1, 2 and 3 are people with normal blood glucose, and 4, 5 and 6 are patients with high blood glucose. Table 1 shows the blood glucose values ​​of the 6 people measured at different time periods;

[0083] Table 1: Blood sugar levels of 6 people at different time periods

[0084]

[0085]

[0086] According to the data in Table 1, the blood glucose difference ΔX and deviation rate ΔY of the six people in different time periods are calculated, and the postprandial blood glucose curves of the six people in different time periods are drawn, as shown in Figures 6 to 11 The calculation results are shown in Table 2;

[0087] Table 2: Blood glucose difference ΔX and deviation rate ΔY of 6 people at different time periods

[0088]

[0089] according to Figures 6 to 11 From the curve and the calculation results in Table 2, we can find that the blood sugar fluctuations of the tested persons at different times are normal. The blood sugar difference ΔX≤2, ΔY≤15 is normal and can also be set according to the doctor's requirements. It can be found that the blood sugar of No. 4 and No. 6 fluctuates greatly in a short period of time. The blood glucose meter will emit a warning sound to remind the patient to re-measure the blood sugar to confirm whether it is a mismeasurement and ensure the measurement accuracy. After re-measurement, if the fluctuation is small, record the measurement result. If the fluctuation is still large, remind the patient to control blood sugar and seek medical treatment in time.

[0090] The above shows and describes the basic principles, main features and advantages of the present invention. It should be understood by those skilled in the art that the present invention is not limited to the above embodiments. The above embodiments and descriptions are only for explaining the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention may have various changes and improvements, which fall within the scope of the present invention. The scope of protection of the present invention is defined by the attached claims and their equivalents.

Claims

1. A biosensor, characterized in that: include: Substrate (1); A reaction layer (11), wherein the reaction layer (11) is fixed inside the substrate (1); An electrode sheet (12), the electrode sheet (12) being fixedly connected to one end of the outer side of the substrate (1), and the electrode sheet (12) being electrically connected to the reaction layer (11); A collection pipeline (13), the collection pipeline (13) being opened at an end of the substrate (1) away from the electrode sheet (12), and the collection pipeline (13) being connected to the reaction layer (11); A piston (2), the piston (2) is slidably and sealingly connected in the collection pipe (13), one side of the piston (2) is fixedly connected to a sliding rod (21); the side of the piston (2) away from the sliding rod (21) is fixedly connected to a blood collection needle (3).

2. A biosensor according to claim 1, characterized in that: The outer side of the piston (2) is sleeved with a rubber ring (22).

3. A biosensor according to claim 2, characterized in that: The substrate (1) is fixedly connected to a protective cover (4) at one end thereof close to the liquid inlet (14) of the collection pipe (13).

4. A biosensor according to claim 3, characterized in that: The protective cover (4) is made of a transparent material.

5. A biosensor according to claim 4, characterized in that: The protective cover (4) is trumpet-shaped, the smaller end of the protective cover (4) is fixedly connected to the substrate (1), and the protective cover (4) is made of a flexible material.

6. A biosensor according to claim 5, characterized in that: The larger end of the protective cover (4) is fixedly connected with an aluminum foil (5).

7. A biosensor according to claim 6, characterized in that: The substrate (1) is fixedly connected to a cover plate (6) on the collection pipe (13), and the cover plate (6) is made of a transparent material.

8. A biosensor according to claim 7, characterized in that: The cover plate (6) is provided with scale lines (61).

9. A method for improving the accuracy of a biosensor, characterized in that: The method is applicable to the biosensor according to any one of claims 1 to 8, and the steps of the method are as follows: S1. First, wipe and disinfect the fingertips where blood is to be drawn with alcohol; S2. After the alcohol in S1 is dried, pinch the substrate (1) with your hands, peel off the aluminum foil (5), align the protective cover (4) with the puncture site, slide the slide bar (21), puncture the finger, slide the slide bar (21) in the opposite direction, and suck the fingertip blood at the puncture site into the collection tube (13); S3, after a sufficient amount of blood is collected in the collection tube in S2, the electrode sheet (12) of the substrate (1) is inserted into the blood glucose meter, and the blood glucose meter detects the current change of the reaction layer (11) and reads and displays the blood glucose value; S4, the blood glucose meter records the blood glucose value measured in S3, determines the patient's state as fasting, 1 hour after a meal, 2 hours after a meal, or 3 hours after a meal during measurement, and stores the measured blood glucose value in a corresponding storage space; S5. Record the fasting data measured every day in S4 as X1, X2, ..., X n , compare the X0 measured on an empty stomach on that day with weekly, monthly, quarterly and annual cycles, and calculate the difference ΔX=|X0-X n |, and obtain the difference ΔX with weekly, monthly, quarterly and annual periods respectively w , ΔX m , ΔX q , ΔX y ; S6. Record the data measured one hour after each meal in S4 as A1, A2, ..., A n ; The data measured 2 hours after each meal are recorded as B1, B2, ..., B n ; The data measured 3 hours after each meal are recorded as C1, C2, ..., C n ; And draw the postprandial blood glucose curve F1(x), F2(x), ... F n (x), based on the X0, A0, B0, C0 measured on the day, draw the postprandial blood glucose curve F0(x), and compare it with the weekly, monthly, quarterly and annual cycles to calculate the deviation rate ×100%, and obtain the deviation rate ΔY with weekly, monthly, quarterly and annual periods respectively. w , ΔY m , ΔY q , ΔY y ; S7. Compare the data ΔX or ΔY in S5 and S6 to see if they exceed the threshold. If they exceed the threshold, the blood glucose meter will give an alarm to remind the patient to remeasure the blood glucose for calibration. If the remeasured blood glucose value still has a large deviation, the remeasured blood glucose value will be recorded to remind the patient to control blood glucose and seek medical treatment in time.

Citation Information

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