Biosensor

Abstract

The utility model provides a biosensor which comprises a substrate, a conducting layer arranged on the substrate, carving lines distributed on the conducting layer and electrodes formed by the separation of the carving lines, at least one carving line is provided with an expansion area, and the distance between outer side lines of the expansion area is larger than that between the outer side lines of the carving lines connected with the expansion area. The biosensor disclosed by the utility model is beneficial to improving the qualified rate of finished products in the production and preparation process and ensuring the detection accuracy in the use process of the biosensor.

Description

Technical Field

[0001] The utility model relates to the field of biomedical detection, and particularly relates to a biosensor. Background Art

[0002] Electrochemical sensors for detecting the content of analytes in samples and their supporting test instruments have been widely used in the daily monitoring of diseases. For example, diabetic patients usually use electrochemical sensors to monitor the glucose concentration in their daily blood.

[0003] The basic structure of such electrochemical sensors includes: an electrode system disposed on an insulating substrate, the electrode system including a working electrode, a counter electrode, and multiple or various types of electrodes, and a reagent that reacts with the analyte covering the corresponding electrode. A sample spacer with a groove is located on the electrode, and a cover sheet with air holes covers the sample spacer. The insulating substrate, the spacer, and the cover sheet form an injection channel, and the other end of the electrode system contacts the contacts of the test instrument. The sample flowing into the injection channel reacts with the reagent on the electrode to generate an electrical signal, and the test instrument obtains the detection result based on these electrical signals.

[0004] The electrodes can be formed on the insulating substrate by screen printing. The electrodes can also be formed by uniformly covering a thin film conductive layer on the insulating substrate in advance and using a laser etching process to form the electrodes. The thin film conductive layer can be selected from metal conductive layers such as gold and palladium, or non-metal conductive layers such as carbon and conductive glass.

[0005] The properties of the thin film conductive layer will affect the structure, electrode design, manufacturing process, user experience, and test performance of the biosensor. If the thin film conductive layer is soft and loose in texture, or has a general adhesion to the insulating substrate, then under the action of external forces, conductive particles may peel off or detach from the conductive layer. The external forces can be the shearing force on the conductive layer caused by the cutting tool during the process of using a cutting tool to cut the semi-finished sensor into single independent sensors during the manufacturing process of the biosensor, or the scraping external force of the instrument detection pins on the sensor when the user inserts the sensor into the test instrument, or the mutual scraping external force between sensors during the transportation process after the sensors are packaged into cylinders. These peeled or detached conductive particles may remain in the nearby engraving lines, resulting in a short circuit between two electrodes that should originally be open-circuited on both sides of the engraving line, and the obtained finished product can only be scrapped.

[0006] Through Figures 1 to 5 the following examples are used to illustrate the influence of conductive particles falling into the engraving lines on the test.

[0007] Figure 1 The biosensor shown is a biosensor with a thin film conductive layer. For the convenience of explanation, the upper cover, the spacer, etc. are not shown in Figure 1 asFigure 1 As shown, the cutting tool cuts along a preset route to obtain the conducting layer side lines 21 and 24 of the biosensor. The moving route of the cutting tool intersects the engraving lines 31, 32, 33, 34, 41, and 42. The conductive regions A and the electrode B on both sides of the engraving line 41 are separated by the engraving line 41 and are electrically disconnected from each other. The electrodes D and E on both sides of the engraving line 34 are separated by the engraving line 34 and are electrically disconnected from each other. Figure 2 and Figure 3 are respectively Figure 1 magnified views at the instrument contact end L and the sample contact end R of the sensor. As Figure 2 shown, when the cutting tool cuts along the preset route to obtain the conducting layer side line 24, when cutting to the engraving line 34, due to the mechanical shearing force of the cutting tool on the conducting layer, conductive particles X may peel off or detach from the conducting layer and remain in the engraving line 34, resulting in electrical conduction between the electrode D and the electrode E due to the conductive particles X and causing a short circuit. If such a biosensor is found during the quality inspection in production, it will be treated as a defective product; if the user inserts such a biosensor into the testing instrument, the testing instrument will detect a short circuit between the electrode D and the electrode E and automatically report an error, prompting the user that it cannot be used. As Figure 3 shown, when the cutting tool cuts along the preset route to obtain the conducting layer side line 21, when the tool cuts to the engraving line 41, the conductive particles X that may be peeled off will remain in the engraving line 41, resulting in electrical conduction between the electrode B and the conductive region A, causing a short circuit between the conductive region A and the electrode B, and changing the electrode area of the electrode B at the sample contact end, which may cause fluctuations in the conduction signal and lead to deviations in the sensor test value.

[0008] On the other hand, when the user performs blood glucose detection and inserts the biosensor into the testing instrument, during the insertion process, the contact pins in the testing instrument move relative to the sensor, and the contact pins may scrape the film-like conducting layer exposed outside the biosensor, generating peeled or detached conductive layer particles. These conductive particles generated by scraping remaining between two adjacent conductive regions may also cause a short circuit between the conductive regions on both sides of the engraving line.

[0009] As Figure 4 and Figure 5 shown, the sensor 100 is inserted into the testing instrument 200 for sample determination. Starting from when the conducting layer side line 24 at the instrument contact end side of the sensor contacts the contact pins of the testing instrument until the sensor is inserted into the preset position (i.e., the test position) of the instrument, during the insertion process, the contact pins of the instrument may cause a certain degree of scraping on the conducting layer along their moving path relative to the sensor. After the conducting layer is stressed, there is a certain probability that conductive particles will peel off or detach and remain in the nearby engraving line. As Figure 4As shown, the insertion direction of the sensor relative to the instrument is downward, and at this time, the insertion direction of the instrument relative to the sensor is upward. Figure 5 As shown in Figure 4 a partial enlarged view of the area within the dashed box in []. After the sensor is inserted, the pins α and β inside the test instrument come into contact with the electrode F and the conductive region H respectively to transmit electrical signals to the test instrument. During the insertion process, the pin α first contacts the edge line 24 of the conductive layer of the sensor. At this time, the position of the pin α on the conductive layer is denoted as α1. When the sensor is inserted to the test position, the position of the pin α on the conductive layer of the sensor is denoted as α2. When the pin α moves along the direction of α1→α2 on the sensor, it may scrape against the conductive layer of the sensor. Due to factors such as the material of the conductive layer itself or the poor adhesion between the conductive layer and the insulating substrate, when there is an engraved line 49 on the sensor that intersects the movement path α1→α2, it may cause the peeled conductive particles X to remain in the engraved line 49. If the conductive particles X come into contact with the electrode F and the conductive region H on both sides of the engraved line 49 respectively, a short circuit occurs between the electrode F and the conductive region H that were originally separated by the engraving 49, resulting in the failure of the sensor test. Since this short circuit situation occurs during the user's use, inaccurate detection results are obtained, causing misjudgment by the user. Utility Model Content

[0010] In the prior art, sensors in which conductive particles generated due to factors such as poor adhesion, cutting, and scratching of the thin-film conductive layer remain in the engraved lines, resulting in short circuits between electrodes that were originally open circuits, or sensors in which the electrode dimensions change due to the remaining conductive particles cannot be used for testing. To overcome the problems in the prior art, the present utility model also provides a biosensor, including a substrate, a conductive layer provided on the substrate, dividing lines distributed on the conductive layer, and electrodes formed by being separated by the dividing lines, and at least one of the dividing lines is provided with an enlarged area.

[0011] In some embodiments, the outer edge line spacing of the enlarged area is greater than the outer edge line spacing of the dividing line connected thereto.

[0012] In some embodiments of the present utility model, the enlarged area is formed by expanding at least one outer edge line of the dividing line where the enlarged area is located.

[0013] In some embodiments of the present utility model, the enlarged area is provided at the end where the dividing line where the enlarged area is located intersects the edge line of the conductive layer. Further, the enlarged area is located at the contact end or the sample contact end of the biosensor. In some embodiments, short-circuit prevention areas are provided on all the dividing lines intersecting the edge line of the conductive layer.

[0014] In some embodiments of the present utility model, the enlarged area may also be provided on the moving path of the probe of the testing instrument relative to the biosensor, and is located at the intersection of the moving path and the dividing line where the enlarged area is located. In some embodiments, the short-circuit prevention areas are provided on all the dividing lines intersecting the moving path of the probe.

[0015] In some embodiments of the present utility model, there is no conductive layer in the enlarged area. Or there is a conductive layer in the enlarged area, and the conductive layer in the enlarged area is separated from the conductive layer outside the enlarged area by a dividing line. Further, there is also a dividing line in the enlarged area, which divides the conductive layer in the enlarged area into multiple regions.

[0016] In some embodiments of the present utility model, the enlarged area is formed by the dividing line where the enlarged area is located bifurcating into at least two mutually diverging dividing lines at the connection of the enlarged area, and is enclosed by the mutually diverging dividing lines.

[0017] Further, the dividing line is an engraved line.

[0018] The biosensor may further include a septum layer and an upper cover having an opening groove. A sampling channel is formed between the conductive layer, the opening groove and the upper cover, and there is a reagent in the sampling channel.

[0019] The dividing line of the present utility model may be an engraved line formed in a thin-film conductive layer by laser etching technology. The conductive layer in the engraved line is removed and the insulating substrate is exposed. The dividing line may also be formed by screen printing technology to print the conductive layer on the insulating substrate according to a certain graphic design to form electrodes or conductive regions, and there are gaps for separating the electrodes and conductive regions between the electrodes or between the electrodes and the conductive regions, or dividing lines generated by other technologies.

[0020] Technicians can design the route of the engraving line on the conductive layer according to the actual situation, or set the process parameters of the laser etching of the engraving line. For example, the short-circuit prevention line or short-circuit prevention area can be an engraving line that is wide enough relative to other engraving lines; it can also be that an engraving line is separated at the end close to the edge of the conductive layer to form multiple engraving lines enclosed by the edge of the conductive layer; it can also be that the line width of the engraving line becomes larger at the end where it intersects with the edge of the conductive layer and forms a short-circuit prevention area with the edge of the conductive layer, or the conductive layer on a certain pattern is integrally peeled off by using laser etching technology to achieve the short-circuit prevention design at the end of the engraving line and the edge of the conductive layer. By setting up the short-circuit prevention line or short-circuit prevention area, or forming an enlarged area in a specific area of the engraving line, the present invention can effectively avoid the situation that the conductive areas on both sides of the engraving line (such as between electrodes and the conductive area outside the electrodes) are connected by conductive particles remaining on the engraving line to cause electrical conduction and short circuit, or reduce the occurrence probability of short circuit, ensure the stability of the performance of the finished sensor, and improve the qualified rate and production rate of the sensor production and preparation. The present invention has strong operability and practicability. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a physical sensor without an enlarged area on the engraving line.

[0022] Figure 2 is Figure 1 an enlarged view at L.

[0023] Figure 3 is Figure 1 an enlarged view at R.

[0024] Figure 4 is a schematic diagram of the process of inserting the sensor into the test instrument.

[0025] Figure 5 is a partial enlarged view of the insertion of the contact end of the sensor into the instrument, and is Figure 4 an enlarged view of the dotted area.

[0026] Figure 6 is an exploded view of the biosensor.

[0027] Figure 7 is a flowchart of the manufacturing method of the biosensor.

[0028] Figure 8 is a schematic diagram of the semi-finished large card after laser etching.

[0029] Figure 9 is Figure 8 a schematic diagram of the semi-finished long strip sheet containing several sensor basic units Y after cutting.

[0030] Figure 10 is Figure 6Front schematic diagram of the biosensing conductive layer.

[0031] Figure 11 It is an enlarged view of 10 at L.

[0032] Figure 12 It is an enlarged view of 10 at R.

[0033] Figure 13 It is a schematic diagram of the process of inserting a biosensor with an enlarged area at the intersection of the engraving line and the moving path of the contact feet into a test instrument.

[0034] Figure 14 It is a schematic diagram of a biosensor with an enlarged area at the intersection of the engraving line and the moving path of the contact feet.

[0035] Figure 15 It is Figure 14 An enlarged view of the biosensor at the contact end.

[0036] Figure 16 It is a schematic diagram of the conductive layer of the biosensor of Example 2.

[0037] Figure 17 It is Figure 16 An enlarged schematic diagram at L.

[0038] Figure 18 It is Figure 16 An enlarged schematic diagram at R.

[0039] Figure 19 It is a partial enlarged view of the biosensor of the present utility model inserted into a test instrument.

[0040] Figure 20 It is a schematic diagram of a biosensor with an enlarged area at the intersection of the engraving line and the moving path of the contact feet.

[0041] Figure 21 It is Figure 20 An enlarged view of the biosensor at the contact end.

[0042] Figure 22 It is a schematic diagram of the conductive layer of another biosensor in Example 2.

[0043] Figure 23 It is Figure 22 An enlarged schematic diagram at L.

[0044] Figure 24 It is Figure 22 An enlarged schematic diagram at R.

[0045] Figure 25 It is a schematic diagram of the conductive layer of the biosensor of Example 3.

[0046] Figure 26Yes Figure 25 An enlarged schematic view at L.

[0047] Figure 27 Yes Figure 25 An enlarged schematic view at R.

[0048] Figure 28 It is one of the graphic designs for short - circuit prevention.

[0049] Figure 29 They are four graphic designs in the short - circuit prevention design.

[0050] Figure 30 It is a schematic diagram of a biosensor with an enlarged area at the intersection of the engraving line and the moving path of the pin.

[0051] Figure 31 It is a schematic diagram of a biosensor with an enlarged area at the intersection of the engraving line and the moving path of the pin, and an engraving line is also included in the enlarged area. Specific implementation mode

[0052] The following will specifically elaborate on the present utility model in combination with specific embodiments.

[0053] Embodiment 1:

[0054] As Figure 6 shown, the biosensor 100 includes an insulating substrate 1, a conductive layer 2 disposed on the substrate, an electrode system formed by dividing the conductive layer through engraving lines. The electrode system includes a working electrode E, a counter electrode D, and a reference electrode C. The electrodes have a sample contact end 101 in contact with the sample and a contact end 102 in contact with the contacts of the testing instrument. A reagent layer 6 is added to the corresponding electrodes at the sample contact end. A septum layer 8 with an opening groove 81 covers the sample contact end of the electrodes, and an upper cover 9 covers the septum layer 8. Thus, a sample injection channel is formed between the conductive layer 2, the opening groove 81, and the upper cover 9, and there are electrodes and reagents in the sample injection channel. An air vent 91 is opened on the upper cover 9, and the air vent is located above the opening groove for discharging the gas in the sample injection channel after sample addition.

[0055] The electrodes are formed by dividing the conductive layer 2 through engraving lines, and the engraving lines are insulating gaps left after removing the conductive material. Figure 6 The front view of the corresponding conductive layer 2 can be seen in the appendix Figure 10 , the working electrode E is enclosed by engraving lines 32, 34, 35, 36, 42, 43, 45, the counter electrode D is enclosed by engraving lines 33, 34, 35, 36, 37, 38, 43, 44, 45, 46, 47, and the reference electrode C is enclosed by engraving lines 31, 33, 35, 41, 42, 44.

[0056] The reagent is dispensed onto the corresponding electrodes at the sample contact end. The electrodes extend from the sample contact end to the sensor contact end, and conduct the electrical signals generated by the reaction of the analyte with the reagent to the sensor contact end. Then, the test results are reported to the user via the instrument.

[0057] Take Figure 7 as an example to illustrate a method for fabricating a biosensor as shown in Figure 6 , which includes the following steps.

[0058] Step 1: Laser etching of the electrode pattern: According to the pre-designed electrode pattern, on the raw material with an insulating substrate and a conductive layer, use a laser to etch engraving lines on the conductive layer to form the electrode pattern, obtaining the electrode large cards of multiple sensor basic units Y. Step 2: Adding the reagent layer: Prepare the detection reagent and add the prepared reagent onto the corresponding electrodes where the reagent needs to be added. Step 3: Attach the spacer layer 8 to each sensor basic unit Y. Generally, the spacer layer is placed at the sample contact end of the biosensor. Step 4: Paste the upper cover 9 onto the spacer layer 8 and perform rolling. Step 5: After the upper cover is attached, attach and roll the color layer on top of the upper cover to obtain a semi-finished large card. Step 6: Cutting: Use a cutting tool to cut the semi-finished large card along the preset cutting line to obtain the finished biosensor.

[0059] Specifically, in Step 1, the laser etching technique is used to etch the conductive layer 2 on the surface of the insulating substrate, forming multiple engraving lines 31 - 38 and engraving lines 41 - 49 on the conductive layer 2. The conductive layer is removed within the engraving lines and the insulating substrate is exposed. After being segmented by the engraving lines, the working electrode E, the counter electrode D, and the reference electrode C are formed on the conductive layer. When the laser etching is completed, the electrode large card is obtained. The electrode large card on the insulating substrate contains multiple sensor basic units Y arranged side by side that can be used to fabricate the finished biosensor. Each sensor basic unit Y includes an insulating substrate, an electrode system formed by being segmented by the engraving lines, engraving lines, and other conductive regions formed by etching.

[0060] The laser cutting instrument can apply different laser engraving parameters to the engraving lines, and the line width range of the obtained engraving lines is, for example, 0.020 mm to 0.300 mm. In this example, the line width of the engraving lines is 0.080 mm.

[0061] The material of the conductive layer 2 can include, but is not limited to, conductive metals or conductive non-metals such as gold, silver, platinum, palladium, carbon, graphite, conductive glass, etc., or mixtures thereof. The conductive layer covering method can adopt printing, coating, electroplating, sputtering, etc. In this example, the conductive layer is formed by coating to form a conductive carbon layer (also known as a carbon film). The thickness of the conductive carbon layer can be 1 - 30 μm. The thickness used in this example is about 8 μm. The resistance of the conductive layer is 10 Ω / □ to 100 Ω / □, and in this example, it is preferably 30 Ω / □.

[0062] The reagent contacts the sample in the injection channel and reacts with the substance to be detected in the sample. The injection channel is formed between the opening groove 81 and the upper cover 9, and the surface of the upper cover facing the injection channel is made of a hydrophilic layer material. The material of the septum layer selects, for example, PET as the substrate and is coated with an acrylic resin system as the adhesive material. The thickness of the septum layer is generally 75 μm to 150 μm, and the width of the opening groove is generally 0.7 mm to 1.8 mm. In this example, the thickness of the septum layer is preferably 100 μm, and the width of the opening groove is preferably 1.2 mm.

[0063] The shape of the vent hole on the upper cover can be circular, square, rectangular, linear or other shapes. In this example, the shape of the air hole is preferably rectangular. In this example, the hydrophilic material is preferably 9901P produced by 3M. The vent hole on the upper cover can ensure that the original air in the cavity is smoothly discharged when the blood sample flows into the injection channel, ensuring that the sample can smoothly flow into the cavity.

[0064] The color layer serves to facilitate the identification of the product and protect the reagent strip from scratches. If the upper cover itself prints the product name, which serves a function similar to that of the color layer, then the color layer is not required. Alternatively, the biosensor may not use the color layer.

[0065] During the production process, the material that has been bonded with the septum layer and the upper cover and has multiple sensor basic units Y is generally called a semi-finished large card, or the material that has completed steps 1 to 4 or steps 1 to 5 is called a semi-finished large card.

[0066] In the cutting step 6, a cutting tool is used along a preset cutting line. As Figure 8 shown, the cutting tool cuts the semi-finished large card along the positions shown by the dashed line 50 and the dashed line 51 in Figure 8 to obtain the finished biosensor. Suitable cutting methods include, but are not limited to, hob rolling cutting, die punching, chopping, etc. In this example, a hob is used to roll cut the semi-finished large card shown in Figure 8 along the horizontal dashed line 50 into a semi-finished long strip sheet containing several sensor basic units Y as shown in Figure 9 , and then the semi-finished long strip sheet is cut with a hob along the vertical dashed line 51 to obtain the finished biosensor. When introducing the cutting process of step 6 in Figure 8 and Figure 9 , in order to more intuitively illustrate the cutting position of the hob, Figure 8 and Figure 9 do not show the septum layer and the upper cover. The dashed lines 50 and 51 marked in Figure 8 and Figure 9 do not exist in the actual product processing process.

[0067] Due to the mechanical shearing force of the cutting tool on the conductive layer, it is very difficult to observe the conductive particles remaining in the engraved line. The resulting risk is mainly that it may cause a short circuit between adjacent electrodes or electrical conduction between the electrode and the conductive area outside the electrode. To eliminate or reduce the probability of generating such unqualified sensors, the present utility model adds a short-circuit prevention line or a short-circuit prevention area to the relevant engraved line, that is, adds a short-circuit prevention engraved line or expands the engraved line in a certain area of the engraved line to form an enlarged area. The line width of the enlarged area is greater than the line width of the engraved line where the enlarged area is located. For example, the line width of a part of the engraved line is moderately widened to reduce the short-circuit risk caused by conductive particles, and the local line width of the engraved line is moderately widened to form a short-circuit prevention area. Even if the peeled or detached conductive particles fall into the short-circuit prevention area, they cannot simultaneously contact the electrodes or conductive areas on both sides of the engraved line, thereby avoiding a short circuit between the electrodes on both sides of the engraved line or between the electrode and the conductive area. In this embodiment, the width of the short-circuit prevention area is 0.14 mm to 0.3 mm, and 0.2 mm is preferably selected in this example. The present utility model can reduce the risk of accidental short circuit of the biosensor.

[0068] As Figure 10 and Figure 10 shown, the enlarged view of the area L at the contact end of the biosensor Figure 11 As shown, the short-circuit prevention area 71 is an area where the line width of the engraved line 34 becomes larger at the end where it intersects with the edge line 24 of the conductive layer. The short-circuit prevention area is also called the engraved line enlarged area, simply referred to as the enlarged area. The outer edge line spacing of the enlarged area is greater than the outer edge line spacing of the engraved line connected thereto. As shown in the figure, at the position where the engraved line 34 is close to the edge line 24 of the conductive layer, the two outer edge lines 341 and 342 of the engraved line 34 extend to the left and right respectively, and then a short-circuit prevention area 71 is formed between the two outer edge lines 343 and 344 that extend outward at the position close to the edge line 24 of the conductive layer. The short-circuit prevention area 71 is connected to the engraved line 34, and the line width of the short-circuit prevention area 71 formed by etching is greater than the width of the engraved line 34. In this example, the conductive layer in the short-circuit prevention area 71 is removed by laser etching. The engraved line width of the short-circuit prevention area 71 is set to be greater than the size of the generally peeled conductive particle X. Even when the cutting tool cuts along the preset route to obtain the edge line 24 of the conductive layer, even if there are conductive particles X remaining in the engraved line 71, it will not cause electrical conduction between the electrode D and the electrode E. The short-circuit prevention area can prevent the two electrodes that were originally open circuits on both sides of the engraved line from being short-circuited due to the conductive particles remaining in the engraved line or reduce the risk of short circuit between the two electrodes.

[0069] As Figure 10 and Figure 10 shown, the enlarged view of the area R at the sample contact end of the biosensor Figure 12As shown, the short - circuit prevention area 71 is an area where the line width of the engraving line 41 becomes larger at the end where it intersects with the edge line 21 of the conductive layer. As shown in the figure, at the position where the engraving line 41 is close to the edge line 21 of the conductive layer, the two outer edge lines 411 and 412 of the engraving line 41 expand upward and downward respectively, and then a short - circuit prevention area 71 is formed between the two outer edge lines 413 and 414 that expand outward at the position close to the edge line 21 of the conductive layer. The short - circuit prevention area 71 is connected to the engraving line 41, and the line width of the short - circuit prevention area 71 formed by etching is greater than the width of the engraving line 41. In this example, the conductive layer within the short - circuit prevention area 71 is removed by laser etching. The engraving line width of the short - circuit prevention area 71 is set to be greater than the size of the conductive particles X peeled off under normal circumstances. Even when the cutting tool cuts along the preset route to obtain the edge line 21 of the conductive layer, even if there are conductive particles X remaining in the engraving line 71, it will not cause electrical conduction between the electrode B and the conductive area A. The short - circuit prevention area can prevent the electrodes on both sides of the engraving line and the outer conductive area of the electrode from being short - circuited by the remaining conductive particles, or reduce the risk of short - circuit between the two electrodes.

[0070] As Figures 13 to 15 shown, the electrode F and the conductive area H on the sensor 100 are separated by the engraving line 49. A short - circuit prevention area 72 is provided in the area where the moving path of the instrument contact intersects with the engraving line 49, that is, the line width of the engraving line 49 in this area becomes larger to form the short - circuit prevention area 72, and the line width of the short - circuit prevention area 72 is greater than that of the engraving line 49 where this short - circuit prevention area is located. During the process of inserting the sensor 100 into the test instrument, the contact of the test instrument touches the end edge 24 of the sensor contact. At this time, the position of the contact on the conductive layer is denoted as α1. When the sensor is inserted into the test position, the position of the contact on the conductive layer of the sensor is denoted as α2. During the movement of the contact on the sensor from α1 to α2, the instrument contact may touch the conductive layer, and the two scrape against each other, resulting in the peeling of conductive particles X. Since the line width of the short - circuit prevention area 72 is greater than that of the conductive particles X, if the free conductive particles X remain in the short - circuit prevention area 72, it will not cause a short - circuit due to the presence of the conductive particles X and the connection between the electrode F and the conductance area H.

[0071] Example 2

[0072] The laser etching equipment has a very high user-defined mode and good precision control ability. The pattern obtained by laser etching is consistent with the design, or the deviation between the two is within a reasonable range. The conductive layer located on the insulating substrate is vaporized, melted or disintegrated by the high energy or high temperature generated by laser focusing, and then the insulating substrate is exposed to form engraving lines. The line width of the engraving lines formed by laser etching is limited by the properties of the laser etching equipment or the conductive layer, and cannot be infinitely enlarged. In this embodiment, the engraving lines with appropriate line widths are spliced together to form a short-circuit prevention area, that is, the short-circuit prevention area is etched by laser etching technology and consists of multiple engraving lines. The laser etching technology can also etch a certain pattern, and the implementation method is similar to completely stripping and removing the conductive layer on the pattern. Based on the above etching method of the laser etching equipment, this embodiment combines Figure 14 is elaborated in detail. In this example, stripping will be used to represent the complete etching and stripping and removal of the conductive layer on a certain pattern by laser etching technology.

[0073] Such as Figures 16 to 18 shown, the short-circuit prevention area in the sensor is formed by stripping the end of the engraving line where it intersects with the edge line of the conductive layer according to a preset image and enclosing it together with the edge line of the conductive layer. Such as Figure 16 and Figure 16 shown, the enlarged schematic of the contact end area L of the biosensor Figure 17 , the short-circuit prevention area 73 connected to the engraving line 34 is semicircular, and is obtained by completely stripping and removing all the conductive layers in this semicircle by laser stripping. As shown in the figure, at the position where the engraving line 34 is close to the edge line 24 of the conductive layer, the two vertical outer edges of the engraving line 34 extend to the left and right respectively to form arc-shaped outer edges, and then a semicircular short-circuit prevention area 73 is formed between the two outer edges that extend outward at the position close to the edge line 24 of the conductive layer. When the cutting tool cuts along the preset route and obtains the edge line 24 of the sensor conductive layer, the conductive particles X generated by scratching may remain in the short-circuit prevention area 73. Since the size of the short-circuit prevention area 73 is larger than the conductive particles X and is insulated, the conductive particles X cannot simultaneously contact the electrode D and the electrode E and cause the electrical conduction of the electrode D and the electrode E. The mutually open-circuited electrodes D and E separated by the engraving line 34 will not be short-circuited due to the presence of the conductive particles X. The design of the present utility model effectively improves the yield of the sensor and ensures the accuracy of the detection performance.

[0074] Such as Figure 16 and Figure 16 The enlarged schematic of the sample contact end area R of the sensor Figure 18, the short - circuit prevention area 73 connected to the engraving line 41 is semi - circular and is obtained by completely stripping all conductive layers in this semi - circle through laser lift - off. As shown in the figure, at the position where the engraving line 41 is close to the conductive layer edge line 21, the two outer edge lines of the engraving line 41 extend upward and downward respectively, forming arc - shaped outer edge lines, and then a semi - circular short - circuit prevention area 73 is formed between the two outer edge lines that extend outward at the position close to the conductive layer edge line 21. When the cutting tool cuts along the preset route and obtains the conductive layer edge line 21 of the sensor, the conductive particles X generated by scratching may remain in the short - circuit prevention area 73. Since the size of the short - circuit prevention area 73 is large and insulated, the conductive particles X cannot conduct electricity between the electrode B and the conductive area A other than the electrode B. The mutually open - circuited electrode B and the conductive area A separated by the engraving line 41 will not be short - circuited due to the conductive particles X, thus ensuring the size of the electrode B, improving the yield of the sensor, and ensuring the accuracy of the finished product performance.

[0075] As Figures 19 to 21 shown, the electrode F on the sensor 100 and the conductive area H at the contact end are separated by the engraving line 49. A circular short - circuit prevention area 74 is provided in the area where the moving path of the instrument contact foot intersects with the engraving line 49, that is, the line width of the engraving line 49 in this area becomes larger to form the short - circuit prevention area 72. The line width of the short - circuit prevention area 74 is greater than the line width of the engraving line 49 where the short - circuit prevention area 74 is located. The short - circuit prevention area 74 is obtained by completely stripping and removing all conductive layers in this circle through laser lift - off. During the process of inserting the sensor 100 into the test instrument, the contact foot of the test instrument touches the end edge 24 of the sensor contact. At this time, the position of the contact foot on the conductive layer is denoted as α1. When the sensor is inserted into the test position, the position of the contact foot on the conductive layer of the sensor is denoted as α2. During the movement of the contact foot on the sensor from α1 to α2, the contact foot of the instrument may touch the conductive layer, and the two scrape against each other, resulting in the peeling off of the conductive particles X. If the peeled - off conductive particles X remain in the short - circuit prevention area 74. Since the line width of the short - circuit prevention area 74 is greater than that of the conductive particles X, the electrode F and the conductance area H will not be connected and short - circuited due to the presence of the conductive particles X. Therefore, the probability of short - circuit caused by the contact foot scraping the conductive layer can be reduced.

[0076] The short - circuit prevention area can be designed as semi - circular and circular as Figure 16 and Figure 21 shown, and can also be triangular as Figure 22 shown. In Embodiment 1 Figure 6 the short - circuit prevention area can also be realized by the laser lift - off technology in this embodiment. Figures 22 to 24 The design of the short - circuit prevention area in Figure 22The short - circuit prevention area 75 of similar triangles shown. The laser stripping mode of the laser etching machine can also be used to obtain short - circuit prevention areas of other shapes.

[0077] Embodiment 3

[0078] As Figures 25 to 27 In the biosensor shown, the short - circuit prevention area 76 located at the sample contact end and the contact end is enclosed by a plurality of engraved lines and the conductive layer edge line together.

[0079] As Figure 26 As shown, the end where the engraved line 34 for separating electrode D and electrode E intersects with the conductive layer edge line 24 branches to obtain a plurality of engraved lines 34a, 34b, and 34c. In this example, at the position where the engraved line 34 is close to the conductive edge line 24, the outer edge lines 341 and 342 of the engraved line 34 extend obliquely to the left and right respectively to the conductive layer edge line 24, so that the outer edge lines 341, 342 of the engraved line and the conductive layer edge line 24 enclose the short - circuit prevention area 76. Among them, the engraved line 34a, 34c and the conductive layer edge line 24 jointly enclose the short - circuit prevention area 76, and the engraved line 34b, 34c and the conductive layer edge line 24 jointly enclose the short - circuit prevention area 76. In this example, the conductive layer in the short - circuit prevention area 76 is not removed. The engraved lines 34a, 34b, and 34c can also be called short - circuit prevention engraved lines. When the cutting tool cuts along the preset cutting line to obtain the sensor conductive layer edge line 24, there may be conductive particles X remaining in the engraved line 34c. The existence of the conductive particles X makes the short - circuit prevention areas 76 that were originally open - circuited on both sides of the engraved line 34c conduct electricity. The engraved line 34a is a section of the engraved line 34 close to the conductive layer edge line. In the prior art, if there are no engraved lines 34a and 34b, the originally open - circuited electrode D and electrode E will be electrically conducted, causing a short - circuit between the sensor electrodes D and E, resulting in defective products or inaccurate tests. Due to the existence of the short - circuit prevention engraved lines 34a and 34b in this embodiment, only the two short - circuit prevention areas are electrically conducted, and the electrodes D and E are still in an open - circuit state. At this time, the sensor electrodes D and E are not affected by the remaining conductive particles X, thus ensuring the performance and the qualified rate of the finished sensor.

[0080] As Figure 27As shown, the engraving line 41 for separating the electrode B and the conductive region A branches at the end portion where it intersects with the side line 21 of the conductive layer to obtain multiple engraving lines 41a, 41b, and 41c. In this example, at the position where the engraving line 41 is close to the conductive side line 21, the outer side lines 411 and 412 of the engraving line 41 extend obliquely upward and obliquely downward respectively to the conductive layer side line 24, so that the outer side lines 411, 412 of the engraving line and the conductive layer side line 24 enclose a short-circuit prevention region. Among them, the engraving line 41a, 41c and the conductive layer side line 21 jointly enclose a short-circuit prevention region 76, and the engraving line 41b, 41c and the conductive layer side line 21 jointly enclose a short-circuit prevention region 76. In this example, the conductive layer within the short-circuit prevention region 76 is not removed. The engraving lines 34a, 34b, and 34c can also be referred to as short-circuit prevention engraving lines. When the cutting tool cuts along the preset cutting line to obtain the conductive layer side lines 21, there may be conductive particles X remaining in the engraving line 41c. The existence of the conductive particles X electrically conducts the electrode B and the conductive region A that were originally electrically isolated on both sides of the engraving line 41c. Without the engraving lines 41a and 41b, the originally electrically isolated electrode B and conductive region A would be electrically conducted, causing a change in the area of the sensor electrode B, thereby leading to a deviation in the test results. In this embodiment, due to the existence of the engraving lines 41a and 41b, the conductive particles X falling into the engraving line 41c only electrically conduct the two short-circuit prevention regions, and the electrode B and the conductive region A are still in an electrically isolated state. At this time, the electrode area of the sensor electrode B is not affected by the remaining conductive particles X, thus ensuring the performance and the qualified rate of the finished sensor.

[0081] As Figure 26 and Figure 27 shown, when the cutting tool cuts along the preset cutting line to obtain the conductive layer side lines 24 and 21, the conductive particles X may also remain in the engraving lines 34a, 34b, 34c and the engraving lines 41a, 41b, 41c. However, only when the engraving lines 34a, 34b, 34c or 41a, 41b, 41c simultaneously have residual conductive particles, will the electrode D and the electrode E, and the conductive region A other than the electrode B be electrically conducted.

[0082] In Figure 28In the example, the engraving line 34 separating the electrode D and the electrode E branches at the end where it intersects with the edge line 24 of the conductive layer to obtain multiple engraving lines 34a and 34b. At the position close to the conductive edge line 24, the outer edge lines 341 and 342 of the engraving line 34 extend obliquely to the left and to the right respectively to the conductive layer edge line 24. Thus, the outer edge lines 341, 342 of the engraving line and the conductive layer edge line 24 enclose a short-circuit prevention area 76, and there is no other engraving line in this short-circuit prevention area 76. The conductive layer within the short-circuit prevention area 76 is not removed by laser etching. The conductive particles X falling within this short-circuit prevention area cannot form electrical conduction between the electrode D and the electrode E. When the cutting tool cuts along the preset cutting line to obtain the conductive layer edge line 24, the conductive particles X may also remain in the engraving lines 34a and 34b. However, only when the conductive particles X remain in both 34a and 34b simultaneously will electrical conduction be formed between the electrode D and the electrode E.

[0083] Compared with the design without a short-circuit prevention area, Figure 26 、 27 and the technical solutions of 28 can both reduce the probability of electrical conduction between electrodes or between the electrode and the conductive layer other than the electrodes. Compared with Figure 28 the scheme shown, Figure 26 and Figure 27 the short-circuit prevention effect of the scheme shown will be better.

[0084] The shapes, quantities, included angles between each other after separation, and starting positions of separation of multiple engraving lines separated from one engraving line can be arranged according to actual situations. For example, it can also be in the shape as shown in Figure 29 . The electrode D and E are separated by the engraving line 34, and the short-circuit prevention area 76 is enclosed by the engraving lines 34a, 34b and / or 34c. The conductive particles X remaining in the engraving line 34c or the short-circuit prevention area will not cause a short circuit between the electrode D and E, thus ensuring the performance accuracy of the finished sensor.

[0085] A short-circuit prevention area formed by multiple engraving lines branched from one engraving line can also be set on the moving path of the test instrument probe on the biosensor. For the biosensor as shown in Figure 30 , a short-circuit prevention area is set near the intersection point of the engraving line 49 and the moving path of the test instrument probe. The engraving line 49 branches into two engraving lines 49a and 49b near this intersection point, and then the engraving lines 49a and 49b protrude outwards and surround and then reconnect to the engraving line 49 again. The circular enlarged area 77 formed by the engraving lines 49a and 49b is the short-circuit prevention area, and the diameter of its enlarged area is larger than that of the conductive particles X. If the conductive particles X remain in the short-circuit prevention area 77, it will not cause a short circuit due to the connection between the electrode F and the conductance area H because of the existence of the conductive particles X, and the short-circuit risk brought by the probe scratching the conductive layer can be reduced. For the biosensor as shown in Figure 31 the biosensor shown andFigure 30 The settings are basically the same, except that a short-circuit prevention area is set near the intersection of the engraving line 49 and the moving path of the test instrument probe, and the engraving line 49 branches into three engraving lines 49a, 49b, and 49c near this intersection. Compared with Figure 30 the short-circuit prevention scheme shown, Figure 31 the short-circuit prevention effect of the example will be better.

[0086] Technicians can comprehensively consider factors such as production efficiency and short-circuit prevention effect, select a suitable pattern for the short-circuit prevention area to fabricate the biosensor, improve the qualified rate of the finished sensor, and ensure the detection accuracy of the sensor.

[0087] The biosensor produced and prepared by the method of the present utility model has a high qualified rate. After multiple performance tests, the prepared biosensor is used to detect the sample, and the detection results meet the relevant regulations of the product performance. The biosensor can be used for detecting physiological indexes such as blood glucose, renal function, and blood lipid.

Claims

1. A biosensor, comprising a substrate, a conductive layer provided on the substrate, dividing lines distributed on the conductive layer, and electrodes formed by dividing the conductive layer by the dividing lines, characterized in that, At least one dividing line is provided with an enlarged area, and the outer edge line spacing of the enlarged area is greater than the outer edge line spacing of the dividing line connected thereto.

2. The biosensor according to claim 1, wherein The enlarged area is formed by expanding at least one outer edge line of the dividing line where the enlarged area is located.

3. The biosensor according to claim 1, characterized in that, The enlarged area is provided at the end where the dividing line where the enlarged area is located intersects with the edge line of the conductive layer.

4. The biosensor according to claim 2, characterized in that, The enlarged area is provided at the contact end of the biosensor or the sample contact end of the biosensor.

5. The biosensor according to claim 1, characterized in that, The enlarged area is provided on the moving path of the contact leg of the test instrument relative to the biosensor, and is located at the position where the moving path intersects with the dividing line where the enlarged area is located.

6. The biosensor according to claim 5, wherein, Short-circuit prevention areas are provided on all dividing lines intersecting with the edge line of the conductive layer, or short-circuit prevention areas are provided on all dividing lines intersecting with the moving path of the contact leg.

7. The biosensor according to any one of claims 1 to 6, characterized in that, There is no conductive layer in the enlarged area.

8. The biosensor according to any one of claims 1 to 6, characterized in that, A dividing line is further provided in the enlarged area to divide the conductive layer in the enlarged area into multiple areas.

9. The biosensor according to any one of claims 1 to 6, characterized in that, The dividing line is a engraved line.

10. The biosensor according to any one of claims 1 to 6, characterized in that, The biosensor further includes a middle partition layer and an upper cover having an opening groove. An injection channel is formed between the conductive layer, the opening groove and the upper cover, and there is a reagent in the injection channel.

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