Electrochemical sensor, continuous analyte measurement device including the electrochemical sensor, and manufacturing method of the electrochemical sensor

Abstract

The continuous analyte measuring device of the present invention may include: an electrochemical sensor including a distal end portion formed with a plurality of electrodes that react with an analyte in the body, a proximal end portion formed with a sensor board connected to the electrodes, and an intermediate portion located between the distal end portion and the proximal end portion; and a transmitter including a main substrate formed with at least one of a power supply unit, a communication unit, and a control unit, and a housing that houses the main substrate therein, adhered to the skin. The manufacturing method of the electrochemical sensor of the present invention may include: a conductive layer step of laminating a conductive layer above a flexible base layer of the electrochemical sensor; and an insulating layer step of adhering an insulating layer above the conductive layer.

Description

Technical Field

[0001] The present invention relates to an electrochemical sensor at least partially inserted into the body, a continuous analyte measuring device including the electrochemical sensor, and a method for manufacturing the electrochemical sensor. Background Art

[0002] When the inserter is used as a reference position, since one end of the electrochemical sensor connected to the main substrate is located close to the inserter, it can be called the proximal end portion, and the other end of the electrochemical sensor inserted into the body is located far from the inserter, so it can be called the distal end portion.

[0003] The proximal portion of the electrochemical sensor can be electrically connected to the main substrate of the transmitter, and at least a part of the distal portion of the electrochemical sensor can be inserted into the body. The proximal end portion and the distal end portion can be located at opposite ends of each other. The proximal portion of the electrochemical sensor can be electrically connected to the main substrate of the transmitter including the circuit required to measure analytes such as glucose.

[0004] In order to alleviate the pain during insertion and reduce the foreign body sensation during wearing, etc., a flexible base layer can be adopted in the sensor for the electrochemical sensor, and it is necessary to minimize the thickness and size of the electrochemical sensor.

[0005] The smaller the size of the electrochemical sensor, the smaller the area of the electrode formed on the distal portion. In the case where a sufficient electrode area cannot be ensured, signal interference may occur due to noise. Therefore, when manufacturing the electrochemical sensor, it is necessary to consider both reducing the sensor size and ensuring the electrode area.

[0006] The electrochemical sensor needs to minimize its size as much as possible in order to alleviate the pain during insertion and reduce the foreign body sensation. The smaller the size of the electrochemical sensor, the smaller the area of the electrode formed on the distal portion. In the case where a sufficient electrode area cannot be ensured, signal interference may occur due to noise. Therefore, when manufacturing the electrochemical sensor, it is necessary to satisfy the trade-off relationship between reducing the sensor size and ensuring the electrode area. Summary of the Invention

[0007] The present invention can provide an electrochemical sensor and a method for manufacturing the electrochemical sensor that can sufficiently ensure the electrode area for reacting with analytes in the body while reducing the size of the electrochemical sensor.

[0008] In the electrochemical sensor included in the continuous analyte measurement device of the present invention, a via hole penetrating the base layer of the electrochemical sensor can be formed, and through the via hole of the present invention, the sensor plates at the proximal ends formed on both sides of the electrochemical sensor and the electrodes at the distal ends can be electrically connected to each other.

[0009] The continuous analyte measurement device of the present invention may include: an electrochemical sensor including a distal end portion having a plurality of electrodes that react with an analyte in the body, a proximal end portion having a sensor plate connected to the electrodes, and an intermediate portion located between the distal end portion and the proximal end portion; and a transmitter including a main substrate having at least one of a power supply portion, a communication portion, and a control portion formed thereon, and a housing that houses the main substrate therein, adhered to the skin.

[0010] The present invention may dispose the distal end portion of the electrochemical sensor in a portion exposed along the length of the needle, and after the skin is cut by the needle, the distal end portion of the electrochemical sensor may be inserted into the body. The electrochemical sensor may include a flexible base layer, a conductive layer laminated above the base layer, and an insulating layer adhered above the conductive layer.

[0011] The manufacturing method of the electrochemical sensor of the present invention may include: a conductive layer step of laminating a conductive layer above the flexible base layer of the electrochemical sensor; and an insulating layer step of adhering an insulating layer above the conductive layer.

[0012] The electrochemical sensor of the present invention may form a plurality of electrodes and leads extending from each electrode on a substrate, and be divided into a proximal end portion having a plurality of sensor plates connected to the respective leads formed on the upper side of the substrate, and a distal end portion that penetrates into the body interior, including: at least one or more upper side electrodes formed on the upper side of the distal end portion of the substrate and at least one or more lower side electrodes formed on the lower side; upper side leads and lower side leads extending from the upper side electrodes and the lower side electrodes to the proximal end portion on the same plane; and an energization structure that electrically energizes a part of the sensor plate at the proximal end portion through the substrate to connect to the lower side lead.

[0013] In addition, the electrochemical sensor of the present invention may include: a substrate including a proximal end portion having a plurality of sensor plates and a distal end portion that penetrates into the body; at least one or more upper side electrodes formed on the upper side of the distal end portion of the substrate and at least one or more lower side electrodes formed on the lower side; upper side leads extending from each upper side electrode to each sensor plate at the proximal end portion; and an energization structure formed to penetrate the distal end portion of the substrate to electrically connect at least one upper side electrode and the lower side electrode.

[0014] The present invention can ensure a sufficient electrode area or lead (not shown) area by disposing the electrodes of the distal end portion on both side surfaces, thereby reducing the defect rate caused by short circuits, improving the sensitivity of the electrochemical sensor, reducing the misalignment rate when forming a conductive layer, an insulating layer, etc. on the base layer, and reducing the insertion length and insertion width of the inserted distal end portion.

[0015] The present invention can ensure a relatively wide electrode area while reducing the width of the distal end portion by disposing the electrodes of the distal end portion on both side surfaces, can alleviate the pain caused by insertion and reduce the foreign body sensation, and can improve the electrochemical reactivity between the electrode and the in-vivo analyte due to the relatively wide electrode area.

[0016] The electrochemical sensor of the present invention can improve the electrical reliability of the biosensor while simplifying the structure of the electrical connection terminal portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is an upper cross-sectional perspective view of a combined embodiment among an inserter, an electrochemical sensor, and a transmitter of the present invention.

[0018] Figure 2 is an exploded perspective view of a base layer, a conductive layer, and an insulating layer of the electrochemical sensor of the present invention in a first case where the present invention is applied.

[0019] Figure 3 is an explanatory diagram related to a groove and a conductive island of the present invention in the first case.

[0020] Figure 4 is an explanatory diagram related to a virtual portion or an internal groove between conductive islands of the present invention in the first case.

[0021] Figure 5 is an explanatory diagram related to a virtual portion or an internal groove between leads of the present invention in the first case.

[0022] Figure 6 is an embodiment of a case where electrodes and a sensor plate are formed on both side surfaces of the electrochemical sensor of the present invention in the first case.

[0023] Figure 7 is a side view of an embodiment where a via hole is formed at the proximal end portion of the present invention in the first case.

[0024] Figure 8 is Figure 7 a plan view of

[0025] Figure 9 is Figure 7 a rear view of

[0026] Figure 10 In (a) of [figure reference], it is a schematic diagram related to an embodiment of a case where a via hole is formed at the proximal end of the present invention, and Figure 10 in (b) of [figure reference], it is a schematic diagram related to an embodiment of a case where a via hole is formed at the distal end of the present invention in the first case.

[0027] Figure 11 is a sequence diagram related to the manufacturing method of the electrochemical sensor of the present invention in the first case.

[0028] Figure 12 is a side sectional view (a), a plan view (b), and a rear view (c) for explaining an embodiment related to the second case of the electrochemical sensor to which the present invention is applied.

[0029] Figure 13 is a side sectional view (a), a plan view (b), and a rear view (c) for explaining the structure of another embodiment related to the second case.

[0030] Figure 14 is a table summarizing the results of measuring the resistance of the via hole coated with the conductive substance of the present invention on the surface.

[0031] Reference numeral

[0032] 10: proximal end, 11a, 11b, 11c: sensor board, 20: distal end, 21, 21a, 21b: working electrode, 22, 22a, 22b: counter electrode, 23: reference electrode, 30a, 30b, 30c: lead wire, 40: insulating layer, 41: adhesive layer, 50: substrate, 60a, 60b, 60c: energization structure, 100: inserter, 102: drive unit, 200: transmitter, 202: main substrate, 300: needle, 310: needle handle, 400: electrochemical sensor, 402: proximal end, 404: intermediate part, 405: folding part, 406: distal end, 410: base layer, 411: via hole, 411a: first via hole, 411b: second via hole, 412: conductive layer, 414: adhesive layer, 416: insulating layer, 418: selective permeation layer, 418a: first selective permeation layer, 418b: second selective permeation layer, 418c: third selective permeation layer, 418d: fourth selective permeation layer, 420: groove, 420a: internal groove, 420a': first internal groove, 420a": second internal groove, 420b: edge groove, 422: opening, 422a: proximal opening, 422b: distal opening, 424: electrode, 424a: first electrode, 424b: second electrode, 424c: third electrode, 424d: fourth electrode, 424e: fifth electrode, 426: lead wire, 426a: first lead wire, 426b: second lead wire, 426c: third lead wire, 426d: fourth lead wire, 428: sensor board, 428a: first sensor board, 428b: second sensor board, 428c: third sensor board, 428d: fourth sensor board, 430: conductive island, 430a: first conductive island, 430b: second conductive island, 430c: third conductive island, 432: virtual part, 432a: first virtual part, 432b: second virtual part, 490: laser head, W1, W2: groove width. Detailed implementation mode

[0033] Next, as an example, the case of using the electrochemical sensor 400 of the present invention in a continuous glucose monitoring device (CGMS, Continuous Glucose Monitoring System) for measuring the glucose concentration in interstitial fluid or blood will be described. However, the continuous glucose device of the present invention is not limited to the measurement of the glucose concentration in the body, and can also be extended and applied to a continuous analyte measurement device for measuring other biomarkers.

[0034] <Inserter and transmitter>

[0035] Figure 1An embodiment of the combination among the inserter 100, the electrochemical sensor 400, and the transmitter 200 of the present invention is illustrated. Figure 1 The state in which the electrochemical sensor 400 and the transmitter 200 are detached from the inserter 100 and installed inside the inserter 100 before invading or adhering to the body is illustrated.

[0036] Refer to Figure 1 , the electrochemical sensor 400 of the present invention can be adhered to the skin together with the transmitter 200. The transmitter 200 can control the signal measured from the electrochemical sensor 400 and continuously transmit the measured blood glucose value to an external terminal including a mobile phone.

[0037] The external terminal and the transmitter 200 adhered to the skin are separately provided, and can continuously receive the measurement data of the electrochemical sensor 400 from the transmitter 200 in a wireless manner. The user can continuously monitor and diagnose the measurement data of the electrochemical sensor 400 related to biomarkers such as glucose and lactate.

[0038] The electrochemical sensor 400 and the transmitter 200 can be provided to the user in a state of being loaded into the inserter 100 before being adhered to the skin. According to the user's adhesion action, the electrochemical sensor 400 and the transmitter 200 can be detached from the inserter 100 and adhered to the skin.

[0039] One end of the electrochemical sensor 400 connected to the electrical component 230 in the transmitter 200 can be referred to as the proximal end 402, and the other end of the electrochemical sensor 400 that at least partially invades the body can be referred to as the distal end 406. The portion connecting the proximal end 402 and the distal end 406 and disposed between the proximal end 402 and the distal end 406 can be referred to as the middle portion 404, and the portion in the middle portion 404 that can be flexibly bent and the direction of the electrochemical sensor 400 is greatly changed can be called the folding portion 405.

[0040] Invading can mean inserting at least a part of the distal end 406 of the electrochemical sensor 400 into the body.

[0041] The transmitter 200 and the electrochemical sensor 400 can be provided to the user in a state of being bonded to each other before being adhered to the skin.

[0042] The transmitter 200 is located at the first position in the state of being loaded into the inserter 100, and the transmitter 200 can move from the first position to the second position according to the user's action, and the transmitter 200 can be adhered to the skin at the second position. The insertion direction of the transmitter 200 and the electrochemical sensor 400 can be the direction from the first position towards the second position.

[0043] The needle 300 has a bare portion in the longitudinal direction, and a part of the electrochemical sensor 400 can be disposed inside the needle 300. The needle 300 can function to cut the skin and guide the electrochemical sensor 400 so that at least a part of the distal end portion 406 penetrates into the human body along the insertion direction.

[0044] The inserter 100 can include a driving unit 102 for moving the transmitter 200 and the electrochemical sensor 400 from the first position to the second position.

[0045] The driving unit 102 can advance the needle 300 or the transmitter 200 from the first position to the second position so that the needle 300 or the distal end portion 406 is inserted into the skin.

[0046] After the driving unit 102 adheres the transmitter 200 and the electrochemical sensor 400 to the skin at the second position, the driving unit 102 can separate the needle 300 from the transmitter 200 and the electrochemical sensor 400 by retracting the needle 300 from the second position to the third position.

[0047] The driving unit 102 can be connected to the needle handle 310 to which the needle 300 is fixed. The needle handle 310 can be detachably mounted on the driving unit 102.

[0048] An internal space can be provided between the upper housing 210 and the lower housing 220 of the transmitter 200.

[0049] One side of the electrochemical sensor 400 on which the sensor board 428 is formed can face the main substrate 202, and the other side of the electrochemical sensor 400 can be exposed in the internal space of the transmitter 200.

[0050] A contact board 612 electrically connected to the sensor board 428 of the proximal end portion 402 of the electrochemical sensor 400 can be formed on the main substrate 202.

[0051] Since at least a part of the electrochemical sensor 400 penetrates into the skin, in order to relieve the pain during penetration and reduce the foreign body sensation during wearing, etc., a flexible electrochemical sensor 400 or a base layer 410 can be adopted.

[0052] The distal end portion 406 of the electrochemical sensor 400 can be configured to be the portion exposed along the length direction of the needle 300. The end portion of the needle 300 can be located at a position more protruding than the end portion of the distal end portion 406. After the skin is cut by the needle 300, the distal end portion 406 of the electrochemical sensor 400 can be inserted into the body.

[0053] <Electrochemical sensor>

[0054] Next, reference will be made to Figures 2 to 14 to describe in detail the electrochemical sensor 400 of the present invention and the manufacturing method of the electrochemical sensor.

[0055] Figures 2 to 11 related to the first case of the electrochemical sensor 400, while Figures 12 to 14 related to the second case of the electrochemical sensor 400.

[0056] First, reference will be made to Figures 2 to 11 to describe the first case.

[0057] The present invention can be applied not only to the case where the electrode 424 and the sensor plate 428 are formed on one side surface of the electrochemical sensor 400, but also can be extended to the case where the electrode 424 and the sensor plate 428 are formed on both side surfaces of the electrochemical sensor 400.

[0058] The electrochemical sensor 400 of the present invention can selectively react with a part of various analytes including glucose in the body through the electrode 424 at the distal end portion 406 that penetrates into the body.

[0059] When a voltage is applied to the electrode 424 of the present invention, the in-vivo analytes including glucose may undergo an oxidation-reduction reaction, and an electric current will flow through the electrons generated at this time. The generated current depends on the concentration of the in-vivo analytes, whereby the signal of the biomarker including the blood glucose value can be quantified.

[0060] In the distal end portion 406, an electrode 424 that undergoes an oxidation or reduction reaction with sugar by being inserted into the body can be formed. The electrode 424 can include at least one of a working electrode, a counter electrode, and a reference electrode.

[0061] In the proximal end portion 402, a sensor plate 428 connected to the electrode 424 can be formed. The current generated by the electrochemical reaction of the distal end portion 406 with the in-vivo glucose can be connected to the sensor plate 428 in the proximal end portion 402 along the lead 426 formed on the base layer 410. The sensor plate 428 can be electrically connected to the main substrate 202 through the contact plate.

[0062] In the middle part 404, a plurality of leads 426 for connecting the counter electrode 424 and the sensor board 428 can be provided. The plurality of leads 426 can be formed by a laser etching method of irradiating the base layer 410 with a laser and thereby removing a part of the base layer 410. Thereby, the respective leads 426 are arranged in a manner that they do not cross and twist with each other.

[0063] The electrode 424 can include at least one or more working electrodes and reference electrodes. A plurality of counter electrodes can be formed as needed. The counter electrodes can be provided when three or more types of electrodes are used to obtain precise data.

[0064] The working electrode can be a porous platinum electrode and can be made of a porous platinum colloid.

[0065] The reference electrode can be an electrode that can be used as a reference because its potential is constant. The reference electrode can be one of a silver chloride (Ag / AgCl) electrode, a calomel electrode, and a mercury(I) sulfate electrode. When the biomarker is glucose, for in-vivo invasive use, a silver chloride (Ag / AgCl) electrode can be used as the reference electrode.

[0066] In the case of the invasive electrochemical sensor 100, for reasons such as alleviating the pain during invasion and reducing the foreign body sensation during wearing, it is necessary to minimize its size as much as possible. The smaller the size of the electrochemical sensor 400, the smaller the area of the electrode 424 will be. In the case where a sufficient area of the electrode 424 cannot be ensured, signal interference may occur due to noise. Therefore, when manufacturing the electrochemical sensor 400, it is necessary to consider both aspects of reducing the size of the sensor 100 and ensuring the area of the electrode 424.

[0067] The length of the invasive electrochemical sensor 400 inserted into the skin can be in the range of 3 to 12 mm. In the case where the insertion length is 3 mm or less, problems such as a decrease in the stability of the sensor itself and signal stability may occur due to the movement of the organism after the sensor is inserted into the organism. In the case where the insertion length exceeds 12 mm, problems such as an increase in pain and damage to biological tissues such as blood vessels or nerves may occur due to the distribution range of the pain points in the human body. In addition, the width of the invasive part of the distal end portion 406 can be in the range of 100 to 600 μm. The thickness of the invasive part of the distal end portion 406 can be in the range of 10 to 300 μm, and preferably, it can be in the range of 50 to 150 μm.

[0068] Since at least a part of the distal end portion 406 is inserted into the body, when the width of the distal end portion 406 is too large, it may cause problems such as increased pain and a foreign body sensation during invasion, so it needs to be reduced to below a specified width (for example, 600 μm). When three or more electrodes 424 are all arranged on one side surface of the distal end portion 406 that invades the body, in terms of measurement data, in order to ensure the space required for three or more electrodes and the leads 426 connected thereto, it may be necessary to increase the width of the distal end portion 406, but in terms of alleviating pain, it needs to be limited to below the specified width (for example, 600 μm). That is, it is necessary to satisfy the trade-off relationship between the two at the same time.

[0069] The electrodes 424 of the distal end portion 406 can be extended along the base layer 410 through the leads 426 and electrically connected to the sensor board 428 of the proximal end portion 402. Since the leads 426 are arranged in the middle portion 404, when the folding portion 405 bends, the leads 426 can also bend along with it.

[0070] When the transmitter 200 is adhered to the skin and the electrochemical sensor 400 invades the body, the folding portion 405 can maintain a bent state for a long time. In order to reduce the torsional load of the folding portion 405, the width of the middle portion 404 or the folding portion 405 can be smaller than the width of the proximal end portion 402 or the distal end portion 406.

[0071] The number of leads 426 formed on the middle portion 404 or the folding portion 405 can be increased proportionally according to the number of electrodes arranged on the distal end portion 406. The more leads 426 are arranged on the folding portion 405, the more likely it is to cause problems such as a decrease in insulation and a short circuit. Therefore, it is necessary to optimize the width between the leads 426, the number of leads 426, the number of electrodes 424, or the width of the folding portion 405.

[0072] In order to minimize the size of the distal end portion 406 that invades the body while ensuring sufficient space for arranging the electrodes 424, the electrodes 424 can be arranged on both side surfaces of the distal end portion 406.

[0073] By arranging the electrodes 424 of the distal end portion 406 on both side surfaces, sufficient electrode 424 area or lead 426 area can be ensured, thereby reducing the defect rate caused by short circuits, and the sensitivity of the electrochemical sensor 400 can be improved. Also, the alignment defect rate when forming layers such as the conductive layer 412 and the insulating layer 416 on the base layer 410 can be reduced, and at the same time, the insertion length and insertion width of the invading distal end portion 406 can be reduced.

[0074] In order to improve the accuracy of detecting electrochemical signals from the electrode 424 at the distal end 406, the number of working electrodes (WE) disposed at the distal end 406 can be increased.

[0075] The working electrodes including the first working electrode and the second working electrode can be provided in multiple numbers on the same surface of the distal end 406, or at least one can be provided on each of the two side surfaces of the distal end 406.

[0076] The biomarkers that need to react at the electrode 424 can include, for example, glucose, lactose, or ketone.

[0077] The first working electrode and the second working electrode can be composed of the same type of biomarker, thereby enhancing their reactivity and improving the detection accuracy of electrochemical signals. The first working electrode and the second working electrode can be composed of different types of biomarkers, thereby measuring multiple electrochemical signals simultaneously.

[0078] As described above, in order to maintain a narrow width of the distal end 406 while improving the accuracy of detecting electrochemical signals of the electrode 424, an electrode configuration structure on both side surfaces of the distal end 406 may be required.

[0079] Next, reference will be made to Figures 2 to 5 a detailed description of the trench 420 and the conductive island 430 of the present invention.

[0080] The electrochemical sensor 400 of the present invention can include a flexible base layer 410, a conductive layer 412 laminated above the base layer 410, and an insulating layer 416 adhered above the conductive layer 412.

[0081] The trench 420 can be formed by laser etching the conductive layer 412. The widths W1 and W2 of the trench 420 formed by laser etching can be 2 to 200 μm. The widths W1 and W2 of the trench can be increased by moving the laser head 490 that irradiates the laser multiple times and performing laser etching multiple times.

[0082] The electrode 424 and the sensor plate 428 can be formed by a laser etching method of irradiating the conductive layer 412 with a laser and removing a part of the conductive layer. After laminating the conductive layer 412, the edge boundaries of the electrode 424 and the sensor plate 428 can be formed. The leads 426 respectively connected to the electrode 424 and the sensor plate 428, like the electrode 424 and the sensor plate 428, can also be formed by cutting a part of the conductive layer 412 in the vertical direction. After forming the edge boundaries of the electrode 424 and the sensor plate 428, the insulating layer 416 can be adhered.

[0083] The groove 420 can be formed by etching on the conductive layer 412, whereby conductive islands 430 can be formed by patterning on the conductive layer 412. The height of the groove 420 can be the same as the thickness of the conductive layer 412. The thicknesses of the conductive layer 412, the electrode 424, and the sensor plate 428 can all be the same.

[0084] The width of the electrochemical sensor 400 can be 600 microns or less, and the length of the electrochemical sensor 400 can be 3 cm or less. The width of the electrode 424 and the width of the sensor plate 428 can be 500 microns or less, and the width of the lead 426 can be 150 microns or less.

[0085] Even when the pattern of the electrode 424 is very complex and the width of the groove 420 is very narrow, the electrode 424 and the groove 420 can be formed by laser etching without burrs. To simplify the process, it is advisable to sputter a metal including gold or copper on the entire exposed area of the base layer 410 for the conductive layer 412.

[0086] Via holes 411 penetrating the base layer 410 can be provided.

[0087] Through the via holes 411, the conductive layers 412 laminated on both side surfaces of the base layer 410 can be electrically connected to each other.

[0088] The via holes 411 can be formed by a laser etching method of irradiating the base layer 410 with a laser and thereby removing a part of the base layer 410.

[0089] When forming the side electrodes 424, metal can be sputtered simultaneously on the upper side and the back side of the base layer 410 where the via holes 411 are formed. The formation of the conductive layers 412 on both side surfaces as described above can be performed on the upper side and the back side separately at different times, or on both side surfaces simultaneously.

[0090] The electrodes 424 or the leads 426 can be electrically separated from each other through the groove 420. The narrower the groove 420, the more sufficient area of the electrodes 424 for analyte reaction can be ensured. On the contrary, the narrower the groove 420, the worse its insulation may become. By forming the groove by laser etching, the trade-off between miniaturization and insulation can be satisfied simultaneously. The narrower the formation width of the folding portion 405, the further the distortion force can be reduced, and fatigue breakage can be prevented even when the folding portion 405 is in a bent and fixed state for a long time.

[0091] Through the groove 420, the areas required for the lead 426, the electrode 424, or the sensor plate 428 can be easily ensured, while improving the signal conductivity and reducing the short-circuit defect rate.

[0092] Referring to Figure 2 , the electrochemical sensor 400 may include a flexible substrate layer 410 that can be bent when inserted into the body. The substrate layer 410 is made of an insulating material and may include at least one of synthetic resin, polyimide (PI), and polyethylene terephthalate (PET). Preferably, in order to achieve a thin and flexible electrochemical sensor 400, polyimide (PI) can be used as the material of the substrate layer 410. The thickness of the substrate layer or the insulating layer can be 100 microns or less.

[0093] A conductive layer 412 can be formed on the substrate layer 410 by means such as sputtering. The thickness of the conductive layer 412 formed by sputtering metal in atomic or molecular units can be 10 microns or less. The conductive layer 412 can be formed by sputtering metal on the entire exposed area of the substrate layer 410 before forming the edge boundaries of the electrodes 424 and the edge boundaries of the sensor plate 428.

[0094] The electrodes 424 and the sensor plate 428 can be formed by laser etching, which irradiates the conductive layer 412 and removes a part of the conductive layer 412, thereby satisfying the trade-off between miniaturization and insulation.

[0095] The trenches 420 can be formed on the conductive layer 412 before the insulating layer 416 is bonded to the conductive layer 412 through the adhesive layer 414. The conductive layer 412 can be separated into different components through the trenches 420. The conductive layer 412 can distinguish different types of electrodes 424, different leads 426, and different sensor plates 428 through the trenches 420.

[0096] The insulating layer 416 can be adhered after the conductive layer 412 is formed. In order to expose the electrodes 424 and the sensor plate 428 to the outside, the insulating layer 416 in a state where a part corresponding to the electrodes 424 and the sensor plate 428 is removed can be adhered above the conductive layer 412.

[0097] A part of the insulating layer 416 can be removed by using a cutting machine or a punch. In the case where microfabrication is required because the size of the opening 422 of the insulating layer 416 is small, the laser etching method used when forming the trenches 420 of the conductive layer 412 can be used when processing the opening 422 of the insulating layer 416.

[0098] The same applies to the substrate layer 410. Because the vias required for formation on both sides need to be microfabricated, the laser etching method used when forming the trenches 420 of the conductive layer 412 can be used when processing the vias 411 of the substrate layer 410.

[0099] In the case of forming a via hole 411 that cuts a part of the base layer 410, the conductive layer 412 can continuously perform sputtering on both side surfaces without seams using the same metal material along the upper side surface of the base layer 410, the surface of the via hole 411, and the back surface of the base layer 410.

[0100] An opening 422 can be formed through the insulating layer 416. The electrode 424 and the sensor plate 428 formed on the conductive layer 412 can be exposed to the outside through the opening 422. A proximal opening 422a can be formed on the proximal end portion 402, and a distal opening 422b can be formed on the distal end portion 406. A part of the sensor plate 428 can be exposed to the outside through the proximal opening 422a, and a part of the sensor plate 428 exposed through the proximal opening 422a can be electrically connected to the contact plate of the main substrate 202.

[0101] A part of the electrode 424 can be exposed to the outside through the distal opening 422b, and a part of the electrode 424 exposed through the distal opening 422b can come into contact with tissue fluid or blood flow and undergo an electrochemical reaction with the analyte.

[0102] The electrochemical sensor 400 can include a porous selective permeation layer 418 surrounding the surface of the electrode 424. The selective permeation layer 418 is used to react with the analyte in the body reaction and can be coated on the electrode 424 of the distal end portion 406.

[0103] The selective permeation layer 418 can have a mesoporous characteristic. The size of the mesopores can be 2 to 50 nm.

[0104] The type of the selective permeation layer 418 can be determined according to the type of the analyte in the body that needs to react with the electrode 424, and can change according to the type of the coated electrode 424. For example, when the analyte is glucose and the electrode 424 coated with the selective permeation layer 418 is the working electrode, the selective permeation layer 418 can be mesoporous platinum. The porous platinum can be made using a porous platinum colloid. When the analyte is glucose and the electrode 424 coated with the selective permeation layer 418 is the reference electrode, the selective permeation layer 418 can be silver chloride (Ag / AgCl).

[0105] The selective permeation layer 418 can be coated on the electrode 424 through the distal opening 422b in the state of laminating the base layer 410, the conductive layer 412, and the insulating layer 416. When a plurality of distal openings 422b face different types of electrodes, the first selective permeation layer 418a to the fourth selective permeation layer 418d can respectively contain different types of substances.

[0106] An adhesive layer 414 can be provided for bonding the insulating layer 416 to the conductive layer 412. The adhesive layer 414 can be located between the conductive layer 412 and the insulating layer 416. When an opening 422 is formed in the insulating layer 416, an opening 422 can also be formed in the adhesive layer 414.

[0107] In order to repeatedly form the selective permeation layer 418, at least one of dip coating, spraying, and pasting methods can be performed.

[0108] The electrochemical sensors 400 can be formed into a sensor array by connecting the base layers 410 to each other. The electrochemical sensors 400 can perform at least one of forming the conductive layer 412 of each sensor and forming the groove 420 using laser etching or the like on one base layer 410. The formation of the insulating layer 416 and the selective permeation layer 418 can also be performed simultaneously.

[0109] A plurality of electrochemical sensors 400 can simultaneously perform the sensor manufacturing process in an array form connected to each other, and then be separated from each other individually.

[0110] In the case where the electrodes 424 are simultaneously formed on both side surfaces of the distal end portion 406, the conductive layer 412 can be formed in a manner surrounding the base layer 410, and the conductive layer 412 can be simultaneously formed on both side surfaces of the distal end portion 406. In a state where the opening 422 penetrating the insulating layer 416 is formed, the insulating layer 416 can be bonded above the conductive layer 412. The electrodes 424 and the sensor plate 428 can be exposed to the outside through the opening 422.

[0111] Figure 3 The entire electrochemical sensor 400 from the proximal end portion 402 to the distal end portion 406 has been schematically described.

[0112] Refer to Figure 3 , after laminating the conductive layer 412 on the base layer 410 by means such as sputtering, the groove 420 can be formed by means such as laser etching.

[0113] By means such as laser etching, a plurality of conductive islands 430 separated from each other can be provided on the conductive layer 412. Each conductive island 430 can be electrically insulated from each other while forming a closed-loop curved surface.

[0114] The base layer 410 will be exposed at the lower part of the groove 420, and the adjacent conductive islands 430 can be insulated by the groove 420.

[0115] The conductive islands 430 of the proximal end portion 402 can form the sensor plate 428, the conductive islands 430 of the middle portion 404 or the folding portion 405 can form the lead 426, and the conductive islands 430 of the distal end portion 406 can form the electrodes 424.

[0116] The conductive island 430 can be divided into a conductive island 430 where the parts corresponding to the electrode 424 and the sensor plate 428 are exposed to the outside through the cut portion of the insulating layer 416, and a virtual portion 432 of the part that is entirely covered by the insulating layer 416 and not exposed to the outside.

[0117] The first conductive island 430a, the second conductive island 430b, and the third conductive island 430c including different electrodes 424 can be formed. The first conductive island 430a can include a first sensor plate 428a at the proximal end 402, a first lead 426a at the folding portion 405, and a first electrode 424a at the distal end 406.

[0118] The second conductive island 430b can include a second sensor plate 428b at the proximal end 402, a second lead 426b at the folding portion 405, and a second electrode 424b at the distal end 406. The third conductive island 430c can include a third sensor plate 428c at the proximal end 402, a third lead 426c at the folding portion 405, and a third electrode 424c at the distal end 406.

[0119] The first electrode 424a, the second electrode 424b, and the third electrode 424c can be one of a working electrode, a counter electrode, and a reference electrode.

[0120] When forming the conductive islands 430 that are separated from each other while forming a closed-loop curved surface, the virtual portion 432 can be formed between the conductive islands 430. The virtual portion 432 can be used as the conductive island 430 having the electrode 424 or the sensor plate 428 when the insulating layer is exposed. The virtual portion 432 can be completely removed by repeated laser etching or the like. However, it is not necessarily required to remove the virtual portion 432, but electrical insulation can be achieved through the trench. This is another advantage of the present invention.

[0121] After forming the trench 420 pattern on the conductive layer 412, if there are too many virtual portions 432 formed in the lower part covered by the insulating layer 416, in order to prevent a part of the insulating layer 416 from sagging, the virtual portion 432 can be maintained without being removed.

[0122] The trench 420 can include an internal trench 420a or an edge trench 420b. The internal trench 420a can insulate between the conductive islands 430. The internal trench 420a can be disposed in at least one of between the electrodes 424, between the leads 426, and between the sensor plates 428.

[0123] In addition, when the conductive layer 412 is exposed at the edge of the electrochemical sensor 400, it will cause a decrease in insulation. Therefore, it is necessary to prevent the side of the conductive layer 412 from being exposed. After laminating the conductive layer 412, a part of the conductive layer 412 can be cut along the edge of the electrochemical sensor 400. This is the edge trench 420b. Thereby, at the edge position of the electrochemical sensor 400, the insulating layer 416 will be adhered above the base layer 410 and thereby achieve insulation. At the inner part of the edge of the electrochemical sensor 400, the insulating layer 416 can be adhered above the conductive layer 412 laminated above the base layer 410.

[0124] The edge trench 420b can form the outermost contour edge of the conductive layer 412. The edge trench 420b can function to insulate the conductive island 430 located at the outermost contour of the electrochemical sensor 400 from the outside of the sensor 400. When the electrochemical sensors 400 are processed in an array, the edge trench 420b can prevent short circuits between adjacent sensors 400 or prevent short circuits between each other by separating adjacent conductive islands 430.

[0125] The width W1 of the internal trench 420a and the width W2 of the edge trench 420b can be in the range of 5 to 30 μm.

[0126] Figure 4 (a) of can be the case where a plurality of internal trenches 420a are formed between the conductive islands 430, while Figure 4 (b) of can be the case where a single internal trench 420a is formed between the conductive islands 430.

[0127] Figure 5 (a) of can be the case where a plurality of internal trenches 420a are formed between the leads 426 disposed in the middle part 404, while Figure 5 (b) of can be the case where a single internal trench 420a is formed between the leads 426.

[0128] By using a laser etching method that removes a part of the conductive layer 412 with the laser irradiated on the conductive layer 412, the trench 420 can be formed on the conductive layer 412. Through the trench 420, a plurality of conductive islands 430 separated from each other can be formed on the conductive layer 412.

[0129] Through the trench 420, the conductive layer 412 can include a conductive island 430 formed with an electrode 424 and a sensor plate 428 or a virtual part 432 of a part that is completely covered by the insulating layer 416 and not exposed to the outside.

[0130] A virtual part 432 can be provided between the first conductive island 430a and the second conductive island 430b, and a first internal trench 420a' and a second internal trench 420a'' can be provided.

[0131] Thereby, a virtual portion 432 and at least one or more grooves 420 can be formed between the conductive islands 430.

[0132] In the above-described case, short circuits between the conductive islands 430 subjected to fine etching can be prevented by the virtual portion 432. Even when a short-circuit factor occurs in the electrochemical sensor 400, that is, when a short circuit occurs between the conductive island 430 and the adjacent virtual portion 432, short circuits between adjacent conductive islands 430 can be prevented, thereby reducing the probability of measurement errors.

[0133] A plurality of conductive islands 430 can share the groove 420 located between the plurality of conductive islands 430. In the above-described case, instead of providing the virtual portion 432 between the first conductive island 430a and the second conductive island 430b, an internal groove 420a can be provided. Since adjacent conductive islands are electrically separated by a shared internal groove 420a, the electrochemical sensor 400 can be minimized by the width and amplitude of the proximal end portion 402, or the width and amplitude of the distal end portion 406.

[0134] Figure 5 of (a) pair Figure 4 A part of (a) of Figure 5 is magnified, while Figure 4 a part of (b) of

[0135] is magnified. Figure 4 The effects related to the groove 420 structure in Figure 5 can be equally applied to the effects related to the groove 420 structure in

[0136] In Figure 5 In (a) of

[0137] In Figure 5 In (b) of

[0138] The sensor plate 428 can be formed only on one side surface of the proximal end portion 402, or can be formed on both side surfaces of the proximal end portion 402 at the same time.

[0139] Figure 6In the case where the electrodes 424 forming the distal ends 406 are formed on both side surfaces, the sensor plates 428 may be formed on both side surfaces of the proximal end 402 simultaneously. Each of the electrodes 424 on the two side surfaces formed on the distal ends 406 may be electrically connected to each of the sensor plates 428 on the two side surfaces of the proximal end 402 along each of the leads 426 on the two side surfaces formed on the middle portion 404. In the case as described above, it is not necessary to form the vias 411 for electrically connecting the conductive layer 412 formed on one side surface of the base layer 410 and the conductive layer 412 formed on the other side surface of the base layer 410.

[0140] In addition, when the sensor plates 428 are formed on both side surfaces of the proximal end 402 simultaneously, it may be difficult to achieve electrical connection with the contact plates of the main substrate 202 by using only a simple alignment method. For example, in order to energize the sensor plates 428 and the contact plates, a structure that crosses each other or a separate connector portion for inserting or clamping the proximal end 402 may be required.

[0141] Therefore, the sensor plates 428 may be formed only on one side surface of the proximal end 402.

[0142] Figures 7 to 10 This is an embodiment related to the case where the sensor plates 428 are formed only on one side surface of the proximal end 402.

[0143] The sensor plates 428 arranged on one side surface of the proximal end 402 may be arranged in a manner that all are exposed in the first direction. The contact plates of the main substrate 202 may be arranged in a manner that all are exposed in the second direction. The first direction and the second direction may be opposite directions of 180 degrees to each other. Thus, the sensor plates 428 and the contact plates may face each other and be electrically connected to each other.

[0144] Through the vias 411, the first conductive islands formed on one side surface of the base layer 410 and the second conductive islands formed on the other side surface of the base layer 410 may be electrically connected to each other. Through the first conductive islands and the second conductive islands, at least one of between the sensor plates 428 on one side surface and the other side surface, between the leads 426 on one side surface and the other side surface, and between the electrodes 424 on one side surface and the other side surface may be electrically connected to each other.

[0145] The vias 411 may include a first via 411a and a second via 411b.

[0146] The first via 411a may be isolated from the outside through the insulating layer 416.

[0147] When a part of the distal end 406 penetrates into the body and the electrode 424 undergoes an oxidation / reduction reaction with the analyte in the body, the electrochemical sensor 400 of the present invention will continuously perform analysis in the state of penetrating into the analyte in the body. Therefore, the first via hole 411a formed in the manner of penetrating through the fine base layer 410 is easily contaminated due to continuous reaction with various substances in the body. The first via hole 411a can be isolated from the outside through the insulating layer 416, thereby reducing the contamination caused by the electrochemical reaction.

[0148] At least one of the two side surfaces of the second via hole 411b can be exposed to the outside.

[0149] The second via hole 411b can be provided on the electrode 424 of the distal end 406 or the sensor board 428 of the proximal end 402 that is exposed to the outside.

[0150] The via hole 411 can be formed in at least one of the proximal end 402, the middle part 404, and the distal end 406.

[0151] Figure 7 And Figure 8 It is the first embodiment of forming the via hole 411 on the base layer 410, and it can be the case where the via hole 411 is formed on the proximal end 402.

[0152] Figure 7 It can be a side view of the first embodiment, Figure 8 (a) of can be a plan view of the first embodiment, while Figure 8 (b) of can be a rear view of the first embodiment.

[0153] Figure 9 It is the second embodiment of forming the via hole 411 on the base layer 410, and it can be the case where the via hole 411 is formed in the distal end 406.

[0154] Figure 9 (a) of can be a side view of the second embodiment, Figure 9 (b) of can be a plan view of the second embodiment, while Figure 9 (c) of can be a rear view of the second embodiment.

[0155] Figure 10 (a) of schematically illustrates the connection relationship of the first embodiment, while Figure 10 (b) of schematically illustrates the connection relationship of the second embodiment.

[0156] The first embodiment of forming the via hole 411 at the proximal end portion 402 and the second embodiment of forming the via hole 411 at the distal end portion 406 are only for the convenience of illustration. The via hole 411 can also be formed in an overlapping manner at the proximal end portion 402, the middle portion 404, or the distal end portion 406 as needed. Therefore, the description related to the via hole 411 can be variously extended according to the number and configuration of the sensor plates 428, the number and configuration of the electrodes 424, or the number or configuration of the via holes 411.

[0157] In the first embodiment, the via hole 411 penetrating the base layer 410 can be provided at the proximal end portion 402.

[0158] On the first side surface of the distal end portion 406, a first electrode exposed in the first direction can be formed, and on the second side surface of the distal end portion 406, a second electrode exposed in the second direction can be formed. The first direction and the second direction can be opposite directions to each other. All the sensor plates 428 on the first side surface of the proximal end portion 402 can be formed in a manner of being exposed in the first direction.

[0159] Through the via hole 411, the second electrode on the second side surface can be electrically connected to the sensor plates 428 on the first side surface in a one-to-one correspondence.

[0160] By forming the via hole 411 at the proximal end portion 402, the electrodes 424 can be arranged on both side surfaces of the distal end portion 406. Thereby, while enhancing the reactivity between the analyte in the body and the electrodes 424, the arrangement area of the electrodes 424 can be increased, and thus the production size of the distal end portion 406 can be reduced.

[0161] Since the part of the electrochemical sensor 400 inserted into the body is the distal end portion 406, by minimizing the size of the distal end portion 406, the pain and foreign body sensation felt by the user can be reduced. The continuous analyte measurement device of the present invention is not for performing intermittent and temporary measurements, but continuously performs measurements within a specified time in a state of being inserted into or adhered to the body. Therefore, the minimization of the distal end portion 406 is crucial.

[0162] The leads 426 respectively connected to the plurality of electrodes 424 can also be dispersedly arranged on both side surfaces of the middle portion 404, thereby achieving the effect of reducing the width of the middle portion 404 compared to the number of the formed electrodes 424.

[0163] The effects of reducing the size of the distal end portion 406 and reducing the width of the middle portion 404 as described above are equally applicable in the case of forming the via hole 411 on the distal end portion 406.

[0164] When measuring an analyte, the transmitter 200 can be adhered to the skin. The proximal end portion 402 can be connected to the contact plate of the transmitter 200, and at least a part of the distal end portion 406 can penetrate into the body. When measuring the analyte in an invasive state, the electrochemical sensor 400 needs to maintain a flexibly bent state on the folding portion 405 of the middle portion 404. Therefore, forming the middle portion 404 with a smaller width is beneficial to the measurement stability of the electrochemical sensor 400.

[0165] If the sensor plate 428 is only exposed and arranged on one side surface of the proximal end portion 402, its width or amplitude may become larger. However, since the sensor plate 428 of the proximal end portion 402 is electrically connected to the contact plate of the transmitter 200, compared with the distal end portion 406 that penetrates into the body, even if its width or service becomes larger, it will not cause any problems.

[0166] When forming the via holes 411 on the proximal end portion 402, multiple electrodes 424 provided on the distal end portion 406 can be configured with multiple types of electrodes having different functions. That is, the electrodes 424 arranged on the same side surface of the distal end portion 406 can have different functions respectively, and the electrodes 424 arranged on both side surfaces of the distal end portion 406 can also have different functions respectively.

[0167] When forming the via holes 411 on the proximal end portion 402, both one side surface and the other side surface of the first via hole 411a can be isolated from the outside by the insulating layer to prevent contamination thereby. One end of the second via hole 411b can be exposed to the outside through the proximal opening portion 422a, and the other end of the second via hole 411b can be isolated from the outside by the insulating layer 416.

[0168] Specifically, in the first embodiment, the first electrode 424a to the fourth electrode 424d can be provided, the first sensor plate 428a to the fourth sensor plate 428d can be provided, and the first lead wires 426a to the fourth lead wires 426d for connecting the electrodes and the sensor plates can be provided. The first electrode 424a and the second electrode 424b can be formed on the first side surface of the base layer 410, and the third electrode 424c and the fourth electrode 424d can be formed on the second side surface of the base layer 410.

[0169] The first electrode 424a can be electrically connected to the second sensor plate 428b along the first lead wire 426a provided on the first side surface of the base layer 410, and the second electrode 424b can be electrically connected to the fourth sensor plate 428d along the second lead wire 426b provided on the first side surface of the base layer 410.

[0170] The third electrode 424c can be connected to the proximal end portion 402 along the third lead 426c provided on the second side surface of the base layer 410, while the fourth electrode 424d can be connected to the proximal end portion 402 along the fourth lead 426d provided on the second side surface of the base layer 410.

[0171] The third electrode 424a can be electrically connected to the third sensor plate 428c disposed on the first side surface through the via hole 411 of the proximal end portion 402, while the fourth electrode 424d can be electrically connected to the first sensor plate 428a disposed on the first side surface through the via hole 411 of the proximal end portion 402.

[0172] The first lead 426a and the second lead 426b can be formed on the first side surface of the base layer 410 in a non-crossing manner with each other, while the third lead 426c and the fourth lead 426d can be formed on the second side surface of the base layer 410 in a non-crossing manner with each other.

[0173] In the first embodiment, the number of the selective permeation layers 418 can be the same as the number of the electrodes 424. On the electrodes of the same type, the same type of selective permeation layer 418 can be coated. In Figure 7 this case, when the types of the first electrode 424a to the fourth electrode 424d are different from each other, the first selective permeation layer 418a to the fourth selective permeation layer 418d coated on each electrode can also be different from each other.

[0174] In the second embodiment, a via hole 411 penetrating the base layer 410 can be provided at the distal end portion 406.

[0175] A first electrode exposed in the first direction can be formed on the first side surface of the distal end portion 406, while a second electrode exposed in the second direction opposite to the first direction can be formed on the second side surface of the distal end portion 406.

[0176] When the via hole 411 is formed on the distal end portion 406, the first electrode and the second electrode can be electrically connected through the via hole 411. The first electrode and the second electrode can be configured as the same type of electrode among a working electrode, a reference electrode, and a counter electrode.

[0177] Therefore, by means of the via hole 411 of the distal end portion 406, electrodes having the same function can be arranged on both side surfaces of the distal end portion 406, thereby reducing the measurement instability caused by the direction in which the electrochemical sensor 400 is inserted into the body or the arrangement relationship between the needle 300 guiding the insertion of the electrochemical sensor 400 into the body and the distal end portion 406.

[0178] When forming the via hole 411 on the distal end portion 406, the lead 426 and the sensor board 428 can be formed only on the first side surface of the base layer 410, and the second side surface of the intermediate portion 404 or the proximal end portion 402 except for the electrode 424 of the distal end portion 406 can be surrounded by the insulating layer 416 and thereby block contact with the outside. Since it is not necessary to provide complex leads 426 on both side surfaces of the relatively thin electrochemical sensor 400, the current stability of the entire electrochemical sensor 400 including short circuits between the leads can be improved.

[0179] When forming the via hole 411 on the distal end portion 406, one side surface and the other side surface of the first via hole 411a can be isolated from the outside by the insulating layer and thereby prevent contamination. One end and the other end of the second via hole 411b can be exposed to the outside through the distal opening portion 422b.

[0180] Through the second via hole 411b, the electrodes on one side surface of the base layer 410 and the electrodes on the other side surface of the base layer 410 can be configured as the same type of electrodes and connected, so that the electro-chemical reactivity between the electrode 424 and the reactants can be enhanced regardless of the directionality of the invaded distal end portion 406.

[0181] Specifically, in the second embodiment, the first electrode 424a to the fourth electrode 424d can be provided, the first sensor board 428a to the fourth sensor board 428d can be provided, and the first lead 426a to the fourth lead 426d for connecting the electrodes and the sensor boards can be provided.

[0182] The first electrode 424a and the second electrode 424b can be formed on the first side surface of the base layer 410, and the third electrode 424c and the fourth electrode 424d can be formed on the second side surface of the base layer 410.

[0183] The first electrode 424a can be electrically connected to the second sensor board 428b along the first lead 426a provided on the first side surface of the base layer 410, and the second electrode 424b can be electrically connected to the first sensor board 428a along the second lead 426b provided on the first side surface of the base layer 410. The fifth electrode 424e can be electrically connected to the third sensor board 428c along the third lead 426c provided on the first side surface of the base layer 410. The present invention can include virtual electrodes in manufacturing such as the fifth electrode 424e, and in the virtual electrodes, the selective permeation layer 418 for reacting with the in-vivo analyte can not be coated.

[0184] The third electrode 424c disposed on the second side of the base layer 410 can be electrically connected to the first electrode 424a disposed on the first side of the base layer 410 through the via hole 411, and the fourth electrode 424d disposed on the second side of the base layer 410 can be electrically connected to the second electrode 424b disposed on the first side of the base layer 410 through the via hole 411. In the case described above, the first electrode 424a and the third electrode 424c can be electrodes of the same type, and the second electrode 424b and the fourth electrode 424d can be electrodes of the same type.

[0185] The first lead 426a and the second lead 426b can be formed on the first side of the base layer 410 in a manner that does not cross each other. By forming the via hole 411 on the distal end portion 406, the number of leads 426 or the number of sensor plates 428 that is less than the number of electrodes 424 can be configured.

[0186] Different from the first embodiment, since the respective electrodes are connected through the via hole 411 in the second embodiment, the selective permeation layers 418 coated on one side and the other side connected through the via hole 411 can be the same. For example, the first electrode 424a and the third electrode 424c can be connected through the via hole 411, and the same first selective permeation layer 418a can be coated on the first electrode 424a and the third electrode 424c.

[0187] Next, reference will be made to Figure 11 A general description of the manufacturing method of the electrochemical sensor 400 of the present invention will be given.

[0188] The manufacturing method of the electrochemical sensor may include: a conductive layer step of laminating a conductive layer 412 above the flexible base layer 410 of the electrochemical sensor 400; and an insulating layer step of adhering an insulating layer 416 above the conductive layer 412.

[0189] The manufacturing method of the electrochemical sensor may include: a via hole step of forming a via hole 411 penetrating the base layer 410.

[0190] The via hole 411 can be formed by a laser or mechanical method. The via hole 411 can be formed by a laser etching method of irradiating the base layer 410 with a laser head 490 and thereby removing a part of the base layer 410.

[0191] The via hole step can be performed before the conductive layer step. The formation of the conductive layer can be performed by a physical vapor deposition method including sputtering.

[0192] The via hole 411 can include a first via hole 411a and a second via hole 411b.

[0193] The first vias 411a can be isolated from the outside through the insulating layer 416, while at least one of the two side surfaces of the second vias 411b can be exposed to the outside.

[0194] The conductive layer steps may include: a first conductive layer step of forming a conductive layer 412 on one side surface of the base layer 410; and a second conductive layer step of forming a conductive layer 412 on the other side surface of the base layer 410.

[0195] Through the first conductive layer step and the second conductive layer step, the conductive layer 412 can be continuously stacked and formed along the upper side surface of the base layer 410, the surface of the vias 411, and the back surface of the base layer 410 without seams using the same metal material.

[0196] The technical features of the present invention are exactly the differences from other technologies that stack multiple layers corresponding to the number of electrodes 424 or sensor plates 428 in order to form the electrodes 424 or sensor plates 428 on the base layer 410. When stacking multiple layers corresponding to the number of electrodes 424 or sensor plates 428 on the electrochemical sensor 400 formed with vias 411, seams such as multiple layer overlaps may appear in the peripheral part of the vias 411. When there are seams such as overlaps in the stacked conductive layers, the thickness of the conductive layer around the vias 411 may not be uniform, which may be the main factor leading to an increase in defect rates such as short circuits.

[0197] Therefore, the conductive layer of the present invention can be formed on the inner peripheral surface of the vias 411, the upper side surface of the base layer 410, and the lower side surface of the base layer 410 in the same layer or in a state indistinguishable from the same layer, thereby minimizing short - circuit defects such as overlaps at both ends of the vias 411 and reducing the conduction defect rate of the vias 411 itself.

[0198] In the insulating layer step, the first vias 411a can face the insulating layer 416, while the second vias 411b can face the opening 422 of the insulating layer 416.

[0199] The insulating layer 412 can be bonded above the conductive layer 412 in a state where an opening 422 penetrating the insulating layer 412 is formed in the insulating layer step. The electrode 424 can be exposed to the outside through the opening 422 and react with the in - vivo analyte. The electrode 424 can be formed on both side surfaces of the distal end portion 406 simultaneously.

[0200] The manufacturing method of the electrochemical sensor may include: a trench step of forming trenches 420 in the conductive layer 412.

[0201] The groove 420 can be formed by laser etching that removes a part of the conductive layer 412 by irradiating the conductive layer 412 with a laser.

[0202] If necessary, a heat treatment step can be performed after the conductive layer step or the insulating layer step.

[0203] A method for manufacturing an electrochemical sensor may include: a selective permeation layer step of coating a selective permeation layer 418 on the opening 422 of the insulating layer 416 by means such as dispensing.

[0204] The material of the selective permeation layer 418 can be determined according to the type of in-vivo analyte that needs to undergo an electrochemical reaction with the electrode 424. For example, in the selective permeation layer step, a selective permeation layer containing platinum can be coated on the working electrode, and a selective permeation layer containing silver chloride can be coated on the reference electrode.

[0205] After the selective permeation layer step, a coating process such as film covering can be additionally performed on the electrochemical sensor 400.

[0206] Next, reference will be made to Figures 12 to 14 A second case of the electrochemical sensor 400 will be described.

[0207] Refer to Figure 12 , the electrochemical sensor 400 may include: a proximal end portion 10, on one side surface of which a plurality of sensor plates 11a, 11b, 11c connected to respective leads 30a, 30b, 30c are formed; and a distal end portion 20, at least a part of which is inserted into the body.

[0208] In an embodiment of the second case, the electrochemical sensor 400 may include: at least one or more upper side electrodes formed on the upper side surface of the distal end portion 20 of the substrate 50 and at least one or more lower side electrodes formed on the lower side surface; upper side leads 30a, 30b, 30c and lower side leads 30a, 30b, 30c, which extend from the upper side electrodes and the lower side electrodes to the proximal end portion 10 on the same plane; and an energization structure 60a, 60b, 60c, which electrically energizes the lower side leads 30a, 30b, 30c by penetrating a part of the sensor plates 11a, 11b, 11c of the proximal end portion 10 through the substrate 50.

[0209] The electrochemical sensor 400 may refer to an electrode assembly in which electrodes, leads, and sensor plates are formed on an insulating substrate 50, or may refer to a sensor body including, for example, an electrode assembly, a power source, a signal processor for processing signals obtained from the electrode assembly, a communication unit, and a housing for housing the components.

[0210] On one side of the proximal end portion 10 of the substrate 50, sensor plates 11a, 11b, and 11c for electrically connecting to the sensor body power supply, signal sensors, etc. can be formed. For the convenience of explanation, the side on which the sensor plates 11a, 11b, and 11c are formed can be referred to as the upper side surface.

[0211] When electrodes and leads 30a, 30b, and 30c are formed on both side surfaces and the sensor plates 11a, 11b, and 11c are simultaneously formed on both side surfaces, the electrical connection structure of the electrochemical sensor 400 may be slightly complex, and the size of the sensor itself may also increase proportionally.

[0212] If the sensor plates 11a, 11b, and 11c are only formed on one side surface of the substrate 50, the electrical connection structure of the electrochemical sensor 400 can be further simplified.

[0213] Since the substrate 50 needs to be inserted into the body and stay for a long time, it is required to be non-toxic to the human body. And because it needs to penetrate the skin tissue, it is required to have sufficient strength and elasticity to move smoothly according to the movement of the human body. And as long as sufficient electrical insulation can be achieved between the upper side surface and the lower side surface, there are no special limitations.

[0214] As an example of the substrate 50 that meets the above requirements, a synthetic resin material can preferably be used. As a specific example, it can be polyimide (PI) or polyethylene terephthalate (PET), but it is not limited thereto.

[0215] In the electrochemical sensor 400 to which the present invention is applied, the width of the distal end portion 20 of the substrate 50 is preferably in the range of 100 to 500 micrometers, and its thickness is preferably in the range of 10 to 500 micrometers.

[0216] This is because when the width of the distal end portion 20 is less than 100 micrometers, the signal-to-noise (S / N) ratio of the sensor may decrease due to the reduction of the electrode area, and the problem of inability to complete the penetration may occur due to insufficient strength of the sensor. And when the width of the distal end portion 20 exceeds 500 micrometers, the problem of increased pain during penetration and increased foreign body sensation during use may occur.

[0217] In the electrochemical sensor 400 to which the present invention is applied, when the thickness of the distal end portion 20 of the substrate is less than 10 micrometers, the problem of inability to complete the penetration may occur due to insufficient strength of the sensor. On the contrary, when it exceeds 500 micrometers, the problem of increased pain during penetration and increased foreign body sensation during use may occur.

[0218] Compared with traditional sensors that form electrodes only on a single side, the electrochemical sensor 400 with electrodes formed on both sides of the substrate 50 can reduce its width to approximately half the level based on the same electrode area (especially the working electrode). Thereby, miniaturization of the sensor can be achieved and user satisfaction of the sensor, such as reducing the pain during insertion and the foreign body sensation during use, can be achieved.

[0219] In addition, when the widths of the two-sided electrode sensor and the single-sided electrode sensor are the same, the area of the electrode can be increased by nearly twice, thereby improving its sensitivity and the signal-to-noise (S / N) ratio by increasing the electrode area, and further reducing the measurement error.

[0220] In addition, the proximal end 10 is relatively less restricted in its size or shape compared with the distal end 20, and can be made into an appropriate shape and size according to the shape or size of the electrochemical sensor 400, etc., and the shape of the electrical connection part.

[0221] The number, shape, and configuration of the electrodes located on both sides of the substrate 50 are not particularly limited.

[0222] For example, one working electrode 21 can be formed on the upper side of the substrate 50, and one counter electrode 22 can be formed on the lower side. Two working electrodes 21a, 21b and a reference electrode 23 can also be formed on the upper side, and one counter electrode 22 can be formed on the lower side. One working electrode 21 and one counter electrode 22 can also be formed on the upper side respectively, and one working electrode and one counter electrode can be formed on the lower side respectively.

[0223] In Figure 12 the above-mentioned structure is disclosed. Preferably, the upper side electrode of the electrochemical sensor 400 can be a working electrode and the lower side electrode can be a counter electrode, or vice versa, the upper side electrode can be a counter electrode and the lower side electrode can be a working electrode.

[0224] In order to ensure the surface area and sensitivity of the working electrode 21, it is advisable to manufacture the electrode using a porous material.

[0225] The electrochemical sensor 400 using a mesoporous platinum electrode can not only improve the glucose sensitivity by about 250 times compared with a flexible platinum electrode, but also can selectively detect only glucose with high selectivity compared with interfering substances, namely ascorbic acid and paracetamol.

[0226] The electrode of the present invention can be a porous platinum electrode, and the porous platinum electrode can be made using platinum colloid.

[0227] The manufacturing method of platinum colloid is as described below.

[0228] A method for manufacturing a platinum colloid may include: a first step of preparing a liquid composition containing a surfactant and metal ions; a second step of adding a reducing agent to the liquid composition to form nanoparticles constituting a first colloid by reducing at least a part of the metal ions; and a third step of removing the surfactant from the first colloid to form a second colloid that contains almost no surfactant.

[0229] In the first step, the surfactant may be an inverse micelle phase containing a plurality of hydrophilic spaces.

[0230] In the second step, at least a part of the molecules of the surfactant bind to at least a part of the nanoparticles, at least a part of the plurality of hydrophilic spaces surround at least one nanoparticle, and no potential may be applied during the reduction of at least a part of the metal ions.

[0231] In the third step, a plurality of irregularly shaped bodies dispersed in the second colloid may be formed by the polymerization of at least a part of the nanoparticles.

[0232] The plurality of irregularly shaped bodies may each contain nanoclusters having a plurality of nanoparticles.

[0233] The nanoparticles have a length between about 2 nm and 5 nm and are generally oval or spherical. The nanoparticles adjacent to each other inside the respective clusters are separated from each other and form a gap between the particles, thus being distributed throughout the cluster.

[0234] The colloid composition may be composed of a first cluster and a second cluster respectively distributed in a liquid. The first cluster and the second cluster may each have a length range of 50 nm to 300 nm.

[0235] The first cluster is composed of first nanoparticles and second nanoparticles. Each nanoparticle is generally oval or spherical and may have a diameter of 2 nm to 5 nm.

[0236] Inside the first cluster, the first nanoparticles and the second nanoparticles are adjacent to each other without nanoparticles being embedded between them, and there may be a particle gap of about 0.5 nm to 3 nm between them.

[0237] The electrochemical sensor 400 may also include a reference electrode 23 on the upper side or the lower side. The reference electrode 23 may be an electrode that can be used as a reference because of its constant monopole potential when measuring the electromotive force or electrode potential of a chemical cell. For example, electrodes such as a silver chloride electrode (Ag / AgCl), a calomel electrode, and a mercury(I) sulfate electrode can be used as the reference electrode 23, and these can also be used as reference electrodes. When used for human purposes, it is advisable to use a silver chloride electrode.

[0238] Refer to Figure 12 In one embodiment of the second case, upper side leads 30a, 30b, 30c and lower side leads 30a, 30b, 30c extending from the upper side electrode and the lower side electrode to the proximal end portion 10 on the same plane may be included.

[0239] The leads 30a, 30b, 30c can function as channels to transfer the constant voltage supplied from the power supply unit of the electrochemical sensor 400 main body to each electrode through the sensor plates 11a, 11b, 11c, and transfer the current generated during the electrochemical reaction occurring in each electrode to the signal processing processor (not shown) of the electrochemical sensor 400 through the sensor plates 11a, 11b, 11c.

[0240] The leads 30a, 30b, 30c can be formed by patterning a metal such as gold (Au) or copper (Cu) which has excellent conductivity, corrosion resistance and is non-toxic to the human body on the substrate 50 by means such as sputtering and then coating an insulating substance.

[0241] The electrochemical sensor 400 includes electrical connection structures 60a, 60b, 60c that are electrically connected to the lower side leads 30a, 30b, 30c by passing a part of the sensor plates 11a, 11b, 11c of the proximal end portion 10 through the substrate 50.

[0242] The electrical connection structures 60a, 60b, 60c can electrically connect the sensor plates 11a, 11b, 11c and the lower side leads 30a, 30b, 30c by continuously coating a conductive substance on at least a part of the via holes formed by penetrating the substrate 50 or filling the via holes with a conductive substance.

[0243] The electrical connection structures 60a, 60b, 60c are a concept of leads penetrating the substrate 50 up and down, and can electrically connect the sensor plates 11a, 11b, 11c formed on the upper side and the leads 30a, 30b, 30c on the lower side.

[0244] Therefore, the electrical connection structures 60a, 60b, 60c can be formed by installing the actual leads in a way that penetrates the substrate 50 up and down, forming via holes and continuously coating a part of the walls of the via holes or filling the entire via holes with a conductive substance.

[0245] However, the method of installing the actual leads is not easy to process, so it is advisable to adopt the method of forming via holes and coating or filling the via holes with a conductive substance.

[0246] The electrical connection structures 60a, 60b, and 60c can be formed by first forming vias and then depositing the same material on the vias while performing physical vapor deposition processes for forming the upper-side and lower-side leads 30a, 30b, and 30c.

[0247] Refer to Figure 13 , in another embodiment of the second case, it may include: a substrate 50 including a proximal end portion 10 formed with a plurality of sensor plates 11a, 11b, and 11c and a distal end portion 20 inserted into the body; at least one upper-side electrode formed on the upper side of the distal end portion 20 of the substrate 50 and at least one lower-side electrode formed on the lower side; upper-side leads 30a, 30b, and 30c extending from the respective upper-side electrodes to the respective sensor plates 11a, 11b, and 11c of the proximal end portion 10; and electrical connection structures 60a, 60b, and 60c formed to penetrate the distal end portion 20 to electrically connect at least one upper-side electrode and the lower-side electrode.

[0248] By connecting the upper-side electrode and the lower-side electrode of the substrate 50 with the electrical connection structures 60a, 60b, and 60c penetrating the upper and lower sides of the substrate 50, an electrode area about twice as large as that of the electrochemical sensor 400 with a single-side structure can be ensured. In the above-described case, since electrical connection between the electrode formed on the lower side of the substrate 50 and the upper-side electrode can be ensured, a separate lower-side lead is not required.

[0249] The electrochemical sensor 400 of the present invention can be manufactured by the method described below.

[0250] First, after processing the substrate 50 such as cutting it into a desired shape and size, vias are formed at a specified position of the proximal end portion 10 or at positions where electrodes need to be formed on the distal end portion 20 of the substrate 50.

[0251] The vias can be formed by laser drilling or mechanical drilling. The vias can be formed in an appropriate size considering the widths of the leads 30a, 30b, and 30c, and the order of processing the substrate 50 and the process of forming the vias can be interchanged.

[0252] Next, leads 30a, 30b, and 30c are formed on the upper side or both sides of the substrate 50, and physical vapor deposition (PVD) such as sputtering is performed to continuously coat a conductive material on at least a part of the vias, and the shapes of the leads 30a, 30b, and 30c are determined by performing laser patterning on the upper side or both sides.

[0253] Next, by forming an insulating layer 40 in a specified form on both side surfaces, the forms of the electrodes and the sensor plates 11a, 11b, 11c, etc. are determined. Then, on the model determined by the insulating layer 40, a step of forming electrodes by filling an electrode material or a precursor of the electrode material using a method such as dispensing is performed, thereby completing the fabrication of the electrochemical sensor 400. In addition, heat treatment can be performed as needed after executing the physical vapor deposition (PVD) / electrode formation process.

[0254] An example of manufacturing the electrochemical sensor 400 of the present invention is described below.

[0255] Manufacturing Example 1)

[0256] As the polyimide film, a polyimide (PI) tip material, namely a GF100 35μm product, was used. On the polyimide film, a via hole with a diameter of 25μm was formed at the proximal end 10 using an INA SP3265 micro laser device of ANI MOTION TECH. Silver sputtering (Au Sputtering) was performed on the front and back surfaces using a continuous winding sputtering device. The approximate thickness of both the front and back surfaces was 1000 Å. An insulating layer 40 pattern was formed on the front and back surfaces using a photoresist of Asahi AZ series.

[0257] A working electrode 21 and a reference electrode 23 were arranged on the front surface, and a counter electrode 22 was arranged on the back surface. 124-36 (Ag / AgCl = 66:43) of Creative materials was dispensed at the reference electrode part using a Musashi IM-350PC and ML-5000X dispensing device. Next, a platinum nanocluster ink manufactured by the applicant was dispensed at the working electrode part using a Musashi IM-350PC and ML-5000X. After the dispensing was completed, an invasive electrode shape was processed using an INA SP3265 micro laser device of ANI MOTION TECH. Next, an outer film was formed by immersing each electrode in a 5% Nafion solution purchased from Merck & Co., Inc. using a dedicated dip coater.

[0258] Manufacturing Example 2)

[0259] A product was fabricated under the same conditions as in Manufacturing Example 1, except that a 75μm product of UBE Corporation was used as the polyimide film and a via hole with a diameter of 100μm was formed at the proximal end.

[0260] Manufacturing Example 3)

[0261] It was the same as Manufacturing Example 1, except that 80 via holes were formed to verify the reliability of the via hole conductivity.

[0262] Figure 14 It is a table for organizing the resistance measurement results of the vias. On the surface of the vias, the conductive material manufactured in Manufacturing Example 1 can be coated. Refer to Figure 14 , it can be confirmed that the resistance of the vias can be maintained at a very low level, and there are no problems with the electrical connection and reliability between the sensor plates 11a, 11b, 11c formed on the upper side and the lower side leads 30a, 30b, 30c.

Claims

1. A continuous analyte measurement device, characterized in that, Comprising: An electrochemical sensor, including a distal end portion formed with a plurality of electrodes that react with an analyte in the body, a proximal end portion formed with a sensor board connected to the electrodes, and an intermediate portion located between the distal end portion and the proximal end portion; And, A transmitter, including a main substrate formed with at least one of a power supply portion, a communication portion, and a control portion, and a housing that houses the main substrate therein, adhered to the skin; The distal end portion of the electrochemical sensor is disposed at a portion exposed along the length direction of the needle, After the skin is cut by the needle, the distal end portion of the electrochemical sensor is inserted into the body, The electrochemical sensor includes a flexible base layer, a conductive layer laminated above the base layer, and an insulating layer adhered above the conductive layer, A via hole penetrating the base layer is formed by a laser etching method of irradiating the base layer with a laser and thereby removing a part of the base layer, After forming a via hole that cuts a part of the base layer by the laser etching, The conductive layer is formed on both side surfaces of the base layer by sputtering a metal onto the base layer, By the sputtering, the conductive layer is continuously laminated without seams along the upper side surface of the base layer, the surface of the via hole, and the back surface of the base layer using the same metal material, The conductive layers laminated on both side surfaces of the base layer are electrically connected to each other through the via hole sputtered with the metal, The via hole is formed in at least one of the proximal end portion, the intermediate portion, and the distal end portion, After forming the via hole by the laser etching and forming the conductive layer by the sputtering, A groove is formed on the conductive layer by laser etching that removes a part of the conductive layer by irradiating the conductive layer with a laser, A plurality of conductive islands separated from each other are formed on the conductive layer through the groove, The plurality of conductive islands share the groove located between the plurality of conductive islands.

2. The continuous analyte measurement device according to claim 1, characterized in that, The insulating layer is adhered above the conductive layer in a state where an opening penetrating the insulating layer is formed, The electrodes are exposed to the outside through the opening, The electrodes are formed on both side surfaces of the distal end portion at the same time.

3. The continuous analyte measurement device according to claim 1, characterized in that, The sensor board is formed only on one side surface of the proximal end portion, The sensor board and the contact board are all exposed in the same direction, The sensor board and the contact board face each other and are electrically connected.

4. The continuous analyte measurement device according to claim 1, characterized in that, A plurality of conductive islands separated from each other are formed on the conductive layer by laser etching that removes a part of the conductive layer by irradiating the conductive layer with a laser, Equipped with a via hole penetrating the base layer, The first conductive island formed on one side surface of the base layer and the second conductive island formed on the other side surface of the base layer are electrically connected to each other through the via hole.

5. The continuous analyte measurement device according to claim 1, characterized in that, Equipped with a via hole penetrating the base layer, The via holes include a first via hole and a second via hole, The first via hole is isolated from the outside through the insulating layer, At least one of the two side surfaces of the second via hole is exposed to the outside.

6. The continuous analyte measurement device according to claim 1, characterized in that Via holes penetrating the base layer are provided in the proximal end, A first electrode exposed in a first direction is formed on a first side surface of the distal end, and a second electrode exposed in a second direction is formed on a second side surface of the distal end, The first direction and the second direction are opposite directions to each other, The first side surface of the proximal end is formed such that all the sensor plates are exposed in the first direction, Through the via holes, the second electrodes on the second side surface are electrically connected to the sensor plates on the first side surface in a one-to-one correspondence.

7. The continuous analyte measurement device according to claim 1, characterized in that Via holes penetrating the base layer are provided in the distal end, A first electrode exposed in a first direction is formed on a first side surface of the distal end, A second electrode exposed in a second direction opposite to the first direction is formed on a second side surface of the distal end, Through the via holes, the first electrode and the second electrode are electrically connected, The first electrode and the second electrode are the same type of electrode among a working electrode, a reference electrode, and a counter electrode.

8. The continuous analyte measurement device according to claim 1, characterized in that A plurality of leads for connecting the electrodes and the sensor plates are provided in the intermediate portion, The plurality of leads are formed by a laser etching method of irradiating the base layer with a laser and thereby removing a part of the base layer, Each lead is arranged in a manner that does not cross and twist with each other.

9. The continuous analyte measurement device according to claim 1, characterized in that By laser etching for removing a part of the conductive layer by irradiating the conductive layer with a laser, a groove is formed in the conductive layer, Through the groove, a conductive island in which the electrodes and the sensor plates are formed and a virtual portion that is entirely covered by the insulating layer and not exposed to the outside are included in the conductive layer, The virtual portion and at least one or more grooves are formed between the conductive islands.

10. A manufacturing method of an electrochemical sensor, characterized in that A continuous analyte measurement device for continuously measuring an analyte in the body, including an electrochemical sensor and a transmitter adhered to the skin together with the electrochemical sensor, The electrochemical sensor includes a distal end formed with a plurality of electrodes that react with an analyte in the body, a proximal end formed with sensor plates connected to the electrodes, and an intermediate portion located between the distal end and the proximal end, The transmitter includes a main substrate formed with at least one of a power supply unit, a communication unit, and a control unit, and a housing that houses the main substrate therein, Including: a conductive layer step of laminating a conductive layer above the flexible base layer of the electrochemical sensor; An insulating layer step of adhering an insulating layer above the conductive layer; and, A via hole step of forming a via hole penetrating the base layer, The via hole step is performed before the conductive layer step, The via hole is formed by a laser etching method of irradiating the base layer with a laser and thereby removing a part of the base layer, The conductive layer step includes: a first conductive layer step of forming a conductive layer on one side surface of the base layer; and a second conductive layer step of forming a conductive layer on the other side surface of the base layer; Through the first conductive layer step and the second conductive layer step, the conductive layer is continuously laminated without seams along the upper side surface of the base layer, the surface of the via hole, and the back surface of the base layer using the same metal material, The manufacturing method of the electrochemical sensor includes: a groove step of forming a groove on the conductive layer; The groove is formed by a laser etching method of removing a part of the conductive layer by irradiating the conductive layer with a laser.

11. The manufacturing method of the electrochemical sensor according to claim 10, characterized in that, In the insulating layer step, the insulating layer is adhered above the conductive layer in a state where an opening penetrating the insulating layer is formed, The electrode is exposed to the outside through the opening, The electrode is formed on both side surfaces of the distal end portion at the same time.

12. The manufacturing method of the electrochemical sensor according to claim 10, characterized in that, Including: A via hole step of forming a via hole penetrating the base layer; The via hole includes a first via hole and a second via hole, The first via hole is isolated from the outside through the insulating layer, At least one of the two side surfaces of the second via hole is exposed to the outside, In the insulating layer step, the insulating layer is adhered above the conductive layer in a state where an opening penetrating the insulating layer is formed, In the insulating layer step, the first via hole faces the insulating layer, and the second via hole faces the opening of the insulating layer.

13. The manufacturing method of the electrochemical sensor according to claim 10, characterized in that, In the insulating layer step, the insulating layer is adhered above the conductive layer in a state where an opening penetrating the insulating layer is formed, Including: a selective permeation layer step of coating a selective permeation layer on the opening; The material of the selective permeation layer is determined according to the type of the in-vivo analyte that needs to undergo an electrochemical reaction with the electrode.

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