KR20240036268A - Continuous analyte device including electrochemical sensor and manufacturing method of electrochemical sensor - Google Patents

Abstract

The continuous analyte measuring device of the present invention is an electrochemical device comprising a distal portion formed with a plurality of electrodes that react with analytes in the body, a proximal portion formed with a sensor pad connected to the electrodes, and an intermediate portion located between the distal portion and the proximal portion. It may include a main board on which at least one of a sensor, a power supply unit, a communication unit, and a control unit is formed, a housing in which the main board is stored, and a transmitter attached to the skin.
The distal portion of the electrochemical sensor may be disposed on a portion exposed along the longitudinal direction of the needle of the present invention, and the distal portion of the electrochemical sensor may be inserted into the body after the skin is incised by the needle, and the electrochemical sensor may be inserted into the body. The sensor may include a flexible base layer, a conductive layer laminated on the base layer, and an insulating layer attached on the conductive layer.
The electrochemical sensor manufacturing method of the present invention may include a conductive layer step of laminating a conductive layer on the flexible base layer of the electrochemical sensor, and an insulating layer step of attaching an insulating layer to the conductive layer.

Description

Continuous analyte device including electrochemical sensor and manufacturing method of electrochemical sensor}

The present invention relates to a continuous analyte measuring device including an electrochemical sensor at least partially invasive into the body, and a method of manufacturing the electrochemical sensor.

When using the inserter as a reference position, one end of the electrochemical sensor connected to the main board is located close to the inserter and can be called the proximal portion, and the other end of the electrochemical sensor inserted into the body is located far from the inserter. It can be called distal.

The proximal portion of the electrochemical sensor may be electrically connected to the main board of the transmitter, and at least a portion of the distal portion of the electrochemical sensor may be inserted into the body. The proximal portion and the distal portion may be located at opposite ends. The proximal portion of the electrochemical sensor may be electrically connected to the main board of the transmitter, which includes the electrical circuitry necessary for measuring analytes, including glucose.

The base layer of the electrochemical sensor can be flexible to relieve pain during invasion and reduce foreign body sensation when worn, and the thickness and size of the electrochemical sensor need to be minimized.

As the size of the electrochemical sensor becomes smaller, the area of the electrode formed at the distal part may also become smaller. If the electrode area is not sufficiently secured, signal disturbance due to noise may occur, so when manufacturing an electrochemical sensor, it is necessary to consider both aspects of reducing the size of the sensor and securing the electrode area.

Electrochemical sensors need to be as small as possible in size to relieve pain and reduce foreign body sensation during invasion. As the size of the electrochemical sensor becomes smaller, the area of the electrode formed at the distal part may also become smaller. If the electrode area is not sufficiently secured, signal disturbance due to noise may occur, so when manufacturing an electrochemical sensor, it is necessary to satisfy both the trade-off relationship between reducing the size of the sensor and securing the electrode area.

The present invention can provide an electrochemical sensor and a method of manufacturing an electrochemical sensor that can secure a sufficient electrode area to react with analytes in the body while reducing the size of the electrochemical sensor.

The electrochemical sensor included in the continuous analyte measuring device of the present invention may be formed with a via hole penetrating the base layer of the electrochemical sensor, and a proximal sensor pad formed on both sides of the electrochemical sensor by the via hole of the present invention or The distal electrodes may be mutually energized.

The continuous analyte measuring device of the present invention is an electrochemical device comprising a distal portion formed with a plurality of electrodes that react with analytes in the body, a proximal portion formed with a sensor pad connected to the electrodes, and an intermediate portion located between the distal portion and the proximal portion. It may include a main board on which at least one of a sensor, a power supply unit, a communication unit, and a control unit is formed, a housing in which the main board is stored, and a transmitter attached to the skin.

The distal portion of the electrochemical sensor may be disposed on a portion exposed along the longitudinal direction of the needle of the present invention, and the distal portion of the electrochemical sensor may be inserted into the body after the skin is incised by the needle, and the electrochemical sensor may be inserted into the body. The sensor may include a flexible base layer, a conductive layer laminated on the base layer, and an insulating layer attached on the conductive layer.

The electrochemical sensor manufacturing method of the present invention may include a conductive layer step of laminating a conductive layer on the flexible base layer of the electrochemical sensor, and an insulating layer step of attaching an insulating layer to the conductive layer.

In the present invention, by arranging the distal electrode on both sides, the area of the electrode or lead (not shown) is sufficiently secured, the defect rate due to short circuit can be reduced, the sensitivity of the electrochemical sensor can be improved, and the base layer can be When forming a conductive layer and an insulating layer, the mismatch rate can be reduced, and the insertion length and insertion width of the distal part that is invaded can be reduced.

In the present invention, by arranging the electrode on both sides of the distal part, it is possible to secure a large electrode area while making the width of the distal part thin, relieve pain caused by invasion and reduce foreign body sensation, and due to the large electrode area, the electrode and the analyte in the body can be removed. Electrochemical reactivity may increase.

1 is a cross-sectional top perspective view of an embodiment of the combination between an inserter, an electrochemical sensor, and a transmitter of the present invention.
Figure 2 is an exploded perspective view of the base layer, conductive layer, and insulating layer of the electrochemical sensor of the present invention.
Figure 3 is an explanatory diagram of the trench and conductive island of the present invention.
Figure 4 is an explanatory diagram of the dummy portion or internal trench between conductive islands of the present invention.
Figure 5 is an explanatory diagram of a dummy portion or internal trench between leads of the present invention.
Figure 6 shows an example in which electrodes and sensor pads are formed on both sides of the electrochemical sensor of the present invention.
Figure 7 is a side view of an embodiment in which a via hole is formed in the proximal portion of the present invention.
Figure 8 is a plan view of Figure 7.
Figure 9 is a rear view of Figure 7.
Figure 10 (a) is a schematic diagram of an embodiment in which a via hole is formed in the proximal part of the present invention, and Figure 10 (b) is a schematic diagram of an embodiment in which a via hole is formed in the distal part of the present invention.
Figure 11 is a flow chart of the manufacturing method of the electrochemical sensor of the present invention.

Hereinafter, an example will be described where the electrochemical sensor 400 of the present invention is used in a continuous glucose monitoring system (CGMS) that measures interstitial fluid or blood glucose concentration. However, the continuous blood glucose device of the present invention is not limited to measuring glucose concentration in the body and can be expanded to a continuous analyte measuring device for measuring other biomarkers.

<Inserter and transmitter>

FIG. 1 may illustrate one example of a combination between the inserter 100, the electrochemical sensor 400, and the transmitter 200 of the present invention. FIG. 1 may illustrate a state in which the electrochemical sensor 400 and the transmitter 200 are mounted inside the inserter 100 before they leave the inserter 100 and invade or attach to the body.

Referring to FIG. 1, the electrochemical sensor 400 of the present invention can be attached to the skin together with the transmitter 200. The transmitter 200 can control the signal measured by the electrochemical sensor 400 and can transmit continuously measured blood sugar levels to an external terminal, including a mobile device.

The external terminal is provided separately from the transmitter 200 attached to the skin, and can continuously receive measurement data of the electrochemical sensor 400 wirelessly from the transmitter 200. The user can continuously monitor and diagnose measurement data of the electrochemical sensor 400 for biomarkers (bio-makers) including glucose, lactate, etc.

The electrochemical sensor 400 and the transmitter 200 may be provided to the user while being loaded into the inserter 100 before attachment to the skin. By the user's attachment action, the electrochemical sensor 400 and the transmitter 200 may be separated from the inserter 100 and attached to the skin.

One end of the electrochemical sensor 400 connected to the electrical component 230 of the transmitter 200 may be referred to as the proximal part 402, and the other end of the electrochemical sensor 400, at least part of which is invasive into the body, may be referred to as the distal part 406. ), the proximal part 402 and the distal part 406 are connected to each other, and the part disposed between the proximal part 402 and the distal part 406 can be called the middle part 404, and in the middle part 404 The part that is flexibly bent and where the direction of the electrochemical sensor 400 changes greatly can be referred to as the folded part 405.

Infiltration may mean inserting at least a portion of the distal portion 406 of the electrochemical sensor 400 into the body.

The transmitter 200 and the electrochemical sensor 400 may be provided to the user in a state that is already adhered to each other before being attached to the skin.

The transmitter 200 is located in the first position while loaded in the inserter 100, and the transmitter 200 moves from the first position to the second position by the user's action. At the second position, the transmitter 200 It may adhere to the skin. The insertion direction of the transmitter 200 and the electrochemical sensor 400 may be from the first position to the second position.

The needle 300 has a portion exposed in the longitudinal direction, and a portion of the electrochemical sensor 400 may be disposed inside the needle 300. The needle 300 may function to incise the skin so that at least a portion of the distal portion 406 can invade into the human body along the insertion direction and guide the electrochemical sensor 400.

The inserter 100 may include a driving unit 102 that operates the transmitter 200 and the electrochemical sensor 400 from the first position to the second position.

The drive unit 102 may advance the needle 300 or the transmitter 200 from a first position to a second position such that the needle 300 or the distal portion 406 is inserted into the skin.

The drive unit 102 attaches the transmitter 200 and the electrochemical sensor 400 to the skin in the second position, and then retracts the needle 300 from the second position to the third position to move the needle 300 to the transmitter 200. ) and can be separated from the electrochemical sensor 400.

The driving unit 102 may be connected to the needle handle 310 on which the needle 300 is fixed. The needle handle 310 can be attached to or detached from the driving unit 102.

An internal space may be provided between the upper housing 210 and the lower housing 220 of the transmitter 200.

One side of the electrochemical sensor 400 on which the sensor pad 428 is formed may face the main board 202, and the other side of the electrochemical sensor 400 may be exposed to the internal space of the transmitter 200.

A contact pad 612 electrically connected to the sensor pad 428 may be formed on the main substrate 202 at the proximal portion 402 of the electrochemical sensor 400.

Since at least a portion of the electrochemical sensor 400 invades into the skin, the electrochemical sensor 400 or the base layer 410 may be flexible to relieve pain upon invasion and reduce foreign body sensation when worn.

The distal portion 406 of the electrochemical sensor 400 may be disposed on an exposed portion along the longitudinal direction of the needle 300. The end of the needle 300 is in a more protruding position than the end of the distal portion 406. The distal portion 406 of the electrochemical sensor 400 may be inserted into the body after the skin is incised by the needle 300.

<Electrochemical sensor>

2 to 11, the electrochemical sensor 400 and the manufacturing method of the electrochemical sensor of the present invention will be described.

The present invention provides not only the case where the electrode 424 and the sensor pad 428 are formed on one side of the electrochemical sensor 400, but also the case where the electrode 424 and the sensor pad 428 are formed on both sides of the electrochemical sensor 400. It can be extended and applied in cases where it is possible.

The electrochemical sensor 400 of the present invention can selectively react with some of various analytes including glucose in the body through the electrode 424 of the distal part 406 that invades the body.

A voltage is applied to the electrode 424 of the present invention so that analytes in the body, including glucose, can be oxidized and reduced, and a current can flow due to the electrons generated at this time. The generated current can be determined according to the concentration of the analyte in the body, so that the signals of biomarkers, including blood sugar levels, can be quantified.

An electrode 424 that can be inserted into the body and perform an oxidation or reduction reaction with sugar may be formed in the distal portion 406. The electrode 424 may include at least one of a working electrode, a counter electrode, and a reference electrode.

A sensor pad 428 connected to the electrode 424 may be formed in the proximal portion 402. The current generated through an electrochemical reaction with glucose in the body in the distal part 406 may be connected to the sensor pad 428 in the proximal part 402 along the lead 426 formed on the base layer 410. The sensor pad 428 may be electrically connected to the main board 202 through a contact pad.

The middle portion 404 may be provided with a plurality of leads 426 connecting the electrode 424 and the sensor pad 428. The plurality of leads 426 may be formed using a laser etching method in which a portion of the base layer 410 is removed by irradiating a laser to the base layer 410 . Accordingly, each lead 426 can be arranged so as not to cross each other and be twisted.

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

The working electrode may be a porous platinum electrode or may be fabricated from porous platinum colloid.

The reference electrode may be an electrode that has a constant potential and can serve as a reference. The reference electrode may be one of a silver chloride (Ag/AgCl) electrode, a calomel electrode, and a mercury (I) sulfate electrode. For in vivo invasive applications when the biomarker is glucose, a silver chloride (Ag/AgCl) electrode can be used as the reference electrode.

In the case of the invasive electrochemical sensor 100, the size needs to be minimized as much as possible for reasons such as relieving pain during invasion and reducing foreign body sensation when worn. As the size of the electrochemical sensor 400 becomes smaller, the area of the electrode 424 may also become smaller. If the area of the electrode 424 is not sufficiently secured, signal disturbance due to noise may occur, so when manufacturing the electrochemical sensor 400, it is necessary to consider both aspects of reducing the size of the sensor 100 and securing the area of the electrode 424. There is.

The length at which the invasive electrochemical sensor 400 is inserted into the skin may range from 3 to 12 mm. If the insertion length is 3 mm or less, the stability of the sensor itself and signal stability may be reduced due to movement of the living body after the sensor is inserted into the living body. If the insertion length exceeds 12 mm, it is located in a range where pain points in the human body are distributed, which can increase pain and damage internal tissues such as blood vessels and nerves. Additionally, the width of the invaded portion of the distal portion 406 may range from 100 to 600 μm. The thickness of the invaded portion of the distal portion 406 may range from 10 to 300 μm, and preferably may range from 50 to 150 μm.

Since at least a portion of the distal part 406 is inserted into the body, if the width of the distal part 406 is too wide, pain and foreign body sensation may increase during invasion, so there is a need to reduce it to a predetermined width (for example, 600㎛) or less. If all three or more electrodes 424 are placed on only one side of the distal part 406 that invades the body, the width of the distal part 406 is It should be wide, but in terms of pain relief, it may be limited to a certain width (for example, 600㎛) or less. Both trade-off relationships must be satisfied.

The electrode 424 of the distal portion 406 may extend along the base layer 410 through a lead 426 and be electrically connected to the sensor pad 428 of the proximal portion 402 . Since the lead 426 is disposed in the middle portion 404, when the folded portion 405 is bent, the lead 426 may also be bent.

When the transmitter 200 is attached to the skin and the electrochemical sensor 400 is invaded into the body, the folded portion 405 may remain bent for a considerable period of time. In order to reduce the torsional load of the folded portion 405, the width of the middle portion 404 or the folded portion 405 may be formed to be narrower than the width of the proximal portion 402 or the distal portion 406.

The number of leads 426 formed in the middle portion 404 or the folded portion 405 may increase in proportion to the number of electrodes disposed in the distal portion 406. As the plurality of leads 426 are arranged in the folded portion 405, the insulation deteriorates and a short circuit may occur. It is necessary to optimize the width between leads 426, the number of leads 426, the number of electrodes 424, or the width of the folded portion 405.

The electrodes 424 may be placed on both sides of the distal portion 406 to minimize the size of the distal portion 406 that invades the body and secure sufficient space for placement of the electrodes 424.

By arranging the electrode 424 on both sides of the distal portion 406, the area of the electrode 424 or the area of the lead 426 is sufficiently secured, the defect rate due to short circuit can be reduced, and the sensitivity of the electrochemical sensor 400 can be increased. It can be improved, the mismatch rate can be reduced when forming the conductive layer 412 and the insulating layer 416 on the base layer 410, and the insertion length and insertion width of the invasive distal part 406 can be reduced. there is.

In order to increase accuracy when detecting an electrochemical signal from the electrode 424 of the distal part 406, the number of working electrodes (WE) disposed in the distal part 406 can be increased.

A plurality of working electrodes including the first working electrode and the second working electrode may be provided on the same side of the distal part 406, or at least one working electrode may be provided on both sides of the distal part 406.

Biomarkers to be reacted at the electrode 424 may include glucose, lactose, or ketone.

The first working electrode and the second working electrode are composed of the same type of biomarker, which can increase the reaction force and improve the detection accuracy of electrochemical signals. The first working electrode and the second working electrode are composed of different types of biomarkers and can measure a plurality of electrochemical signals at the same time.

In this way, in order to increase the accuracy of electrochemical signal detection of the electrode 424 and maintain a narrow width of the distal portion 406, a double-sided electrode arrangement structure of the distal portion 406 may be necessary.

2 to 5, the trench 420 and the conductive island 430 of the present invention will be described.

The electrochemical sensor 400 of the present invention may include a flexible base layer 410, a conductive layer 412 laminated on the base layer 410, and an insulating layer 416 attached on the conductive layer 412. there is.

The trench 420 may be formed by laser etching the conductive layer 412. The widths (W1, W2) of the trench 420 obtained by laser etching may be 2 to 200 ㎛. The laser head 490 that irradiates the laser moves multiple times and laser etching is performed multiple times, and the widths (W1, W2) of the trench can be increased.

The electrode 424 and the sensor pad 428 may be formed by a laser etching method in which a portion of the conductive layer 412 is removed by irradiating a laser to the conductive layer 412. After the conductive layer 412 is stacked, the edge boundary of the electrode 424 and the edge boundary of the sensor pad 428 may be formed. The leads 426 connecting the electrode 424 and the sensor pad 428, respectively, may be formed by cutting a portion of the conductive layer 412 in the vertical direction, like the electrode 424 and the sensor pad 428. The insulating layer 416 may be attached after the edge boundary of the electrode 424 and the edge boundary of the sensor pad 428 are formed.

The trench 420 may be engraved in the conductive layer 412, and the conductive island 430 may be patterned in the conductive layer 412 accordingly. The height of the trench 420 may be the same as the thickness of the conductive layer 412. The thickness of the conductive layer 412, electrode 424, and sensor pad 428 may all be the same.

The width of the electrochemical sensor 400 may be 600 micrometers or less, and the length of the electrochemical sensor 400 may be 3 cm or less. The width of the electrode 424 and the sensor pad 428 may be 500 micrometers or less, and the width of the lead 426 may be 150 micrometers or less.

The electrode 424 and the trench 420 can be formed without burrs through laser etching, no matter how complex the pattern of the electrode 424 is and how narrow the width of the trench 420 is. To simplify the process, it may be desirable for the conductive layer 412 to be sputtered with a metal containing gold or copper over the entire exposed area of the base layer 410.

A via hole 411 penetrating the base layer 410 may be provided.

Through the via hole 411, the conductive layers 412 on both sides stacked on the base layer 410 may be electrically connected to each other.

The via hole 411 may be formed by a laser etching method in which a portion of the base layer 410 is removed by irradiating a laser to the base layer 410 .

When forming the double-sided electrode 424, both the top and back surfaces of the base layer 410 where the via hole 411 is formed can be sputtered with metal. The formation of the double-sided conductive layer 412 may be performed on the top and back surfaces at different times, or may be performed on both surfaces simultaneously.

The electrodes 424 or the leads 426 may be electrically separated from each other by the trench 420 . The narrower the trench 420 is, the more likely it is to secure a sufficient area of the electrode 424 for analyte reaction. Conversely, the narrower the trench 420 is, the worse the insulation may be. By laser etching trench formation, the trade-off between miniaturization and insulation can be satisfied. As the width of the folded portion 405 is formed narrower, torsional force can be reduced, and fatigue failure can be prevented even if the folded portion 405 remains bent and fixed for a considerable period of time.

By using the trench 420, it is easy to secure a sufficient area for the lead 426, the electrode 424, or the sensor pad 428, thereby improving the signal transmission rate and reducing the short circuit defect rate.

Referring to FIG. 2, the electrochemical sensor 400 may include a flexible base layer 410 that can be bent when invasive into the body. The base layer 410 may include at least one of synthetic resin, polyimide (PI), and polyethylene terephthalate (PET) as an insulating material, and is preferably used for the thin and flexible electrochemical sensor 400. Polyimide (PI) may be used as a material for the base layer 410. The thickness of the base layer or insulating layer may be 100 micrometers or less.

The conductive layer 412 may be formed on the base layer 410 using a method such as sputtering. The thickness of the conductive layer 412, which is laminated by blowing metal into atoms or molecules, may be 10 micrometers or less. The conductive layer 412 may be formed by sputtering metal over the entire exposed area of the base layer 410 before the edge boundary of the electrode 424 and the edge boundary of the sensor pad 428 are formed.

The electrode 424 and sensor pad 428 may be formed by a laser etching method that removes a portion of the conductive layer 412 by irradiating a laser to the conductive layer 412, thereby satisfying the trade-off between miniaturization and insulation. You can do it.

A trench 420 may be formed in the conductive layer 412 before bonding the insulating layer 416 to the conductive layer 412 by the bonding layer 414 . The conductive layer 412 may be separated into different members by a trench 420. The conductive layer 412 can be divided into different types of electrodes 424, different leads 426, and different sensor pads 428 by the trench 420. there is.

After forming the conductive layer 412, the insulating layer 416 may be attached. The insulating layer 416 with a portion of the insulating layer 416 corresponding to the electrode 424 and the sensor pad 428 removed so that the electrode 424 and the sensor pad 428 are exposed to the outside is formed into a conductive layer 412. ) can be glued on.

A portion of the insulating layer 416 may be removed using a cutter or punching machine. When the size of the opening 422 of the insulating layer 416 is small and fine processing is required, the laser etching method used to form the trench 420 of the conductive layer 412 is used to process the opening 422 of the insulating layer 412. You can use it.

The same may be true for the base layer 410. Since the via hole 411 required for double-sided formation requires micro-processing, the laser etching method used to form the trench 420 of the conductive layer 412 can be used to process the via hole 411 of the base layer 410.

When the via hole 411 is formed by cutting a portion of the base layer 412, the conductive layer 412 is formed seamlessly along the top surface of the base layer 410, the surface of the via hole 411, and the back surface of the base layer 410. Double-sided sputtering can be done using the same continuous metal material.

A penetrating opening 422 may be formed in the insulating layer 416. The electrode 424 and the sensor pad 428 formed on the conductive layer 412 may be exposed to the outside through the opening 422. A proximal opening 422a may be formed in the proximal portion 402, and a distal opening 422b may be formed in the distal portion 406. A portion of the sensor pad 428 may be exposed to the outside through the proximal opening 162, and a portion of the sensor pad 428 exposed by the proximal opening 162 may be electrically connected to the contact pad of the main board 202. can be connected

A portion of the electrode 424 may be exposed to the outside through the distal opening 164, and a portion of the electrode 424 exposed by the distal opening 164 may contact interstitial fluid or blood flow and undergo an electrochemical reaction with the analyte. can cause

The electrochemical sensor 400 may include a porous selectively transparent layer 418 surrounding the surface of the electrode 424. The selectively transparent layer 418 is intended to react with an analyte that reacts in the body and may be applied to the electrode 424 of the distal portion 406.

The selectively transparent layer 418 may have mesoporous characteristics. The size of the mesopores may be 2 to 50 nm.

The type of selective transmission layer 418 may be determined depending on the type of analyte in the body to react with the electrode 424 and may vary depending on the type of electrode 424 to be applied. For example, if the analyte is glucose and the electrode 424 on which the selectively transparent layer 418 is applied is the working electrode, the selectively transparent layer 418 may be mesoporous platinum. Porous platinum can be produced from porous platinum colloids. If the analyte is glucose and the electrode 424 on which the selectively transparent layer 418 is applied is a reference electrode, the selectively transparent layer 418 may be silver chloride (Ag/AgCl).

The selectively transparent layer 418 may be applied to the electrode 424 through the distal opening 422b with the base layer 410, conductive layer 412, and insulating layer 416 stacked. When the plurality of distal openings 422b face different types of electrodes, the first selectively transparent layer 418a to the fourth selectively transparent layer 418d may each include different types of materials.

A bonding layer 414 may be provided to attach the insulating layer 416 to the conductive layer 412. Bonding layer 414 may be located between conductive layer 412 and insulating layer 416. When forming the opening 422 in the insulating layer 416, the opening 422 may also be formed in the bonding layer 414.

To repeatedly form the selective transmission layer 418, at least one of dip coating, spray coating, and paste methods may be performed.

The electrochemical sensor 400 may form a sensor array by connecting base layers 410 to each other. For the electrochemical sensor 400, at least one of forming a conductive layer 412 for each sensor on one base layer 410 or forming a trench 420 by laser etching, etc. may be performed. The formation of the insulating layer 416 and the selective transmission layer 418 may also be performed at the same time.

The plurality of electrochemical sensors 400 may be individually separated from each other after undergoing a sensor manufacturing process simultaneously in the form of an array connected to each other.

When the electrodes 424 are formed on both sides of the distal portion 406, the conductive layer 412 may be formed to surround the base layer 410, and the conductive layer 412 may be formed on both sides of the distal portion 406. can be formed. With the opening 422 penetrating the insulating layer 416 formed, the insulating layer 416 may be adhered onto the conductive layer 412 . The electrode 424 and the sensor pad 428 may be exposed to the outside through the opening 422.

FIG. 3 may schematically illustrate the entire electrochemical sensor 400 from the proximal portion 402 to the distal portion 406.

Referring to FIG. 3, after the conductive layer 412 is deposited on the base layer 410 by a method such as sputtering, a trench 420 may be formed by a method such as laser etching.

A plurality of conductive islands 430 separated from each other may be provided in the conductive layer 412 by laser etching, etc. Each conductive island 430 forms a closed curved surface and may be electrically insulated from each other.

The base layer 410 is exposed at the bottom of the trench 420, and the adjacent conductive islands 430 may be insulated by the trench 420.

The conductive island 430 of the proximal portion 402 may form a sensor pad 428, and the conductive island 430 of the middle portion 404 or fold 405 may form a lead 426, Conductive island 430 of distal portion 406 may form electrode 424 .

The conductive island 430 includes a conductive island 430 in which parts corresponding to the electrode 424 and the sensor pad 428 are exposed to the outside through a cut portion of the insulating layer 416, and a part exposed to the outside. It can be divided into a dummy part 432 that is entirely covered with an insulating layer 416.

A first conductive island 430a, a second conductive island 430b, and a third conductive island 430c including different electrodes 424 may be formed. The first conductive island 430a may include a first sensor pad 428a in the proximal portion 402, a first lead 426a in the folded portion 405, and a first electrode 424a in the distal portion 406. .

The second conductive island 430b may include a second sensor pad 428b in the proximal portion 402, a second lead 426b in the folded portion 405, and a second electrode 424b in the distal portion 406. . The third conductive island 430c may include a third sensor pad 428c in the proximal portion 402, a third lead 426c in the folded portion 405, and a third electrode 424c in the distal portion 406. .

The first electrode 424a, the second electrode 424b, and the third electrode 424c may be any one of a working electrode, a counter electrode, and a reference electrode.

When forming conductive islands 430 that are separated from each other by forming a closed curved surface, a dummy portion 432 may be formed between the conductive islands 430. The dummy portion 432 can be used as a conductive island 430 with electrodes 424 or sensor pads 428 when the insulating layer is exposed. The dummy portion 432 can be completely removed through repeated laser etching. However, since only electrical insulation needs to be achieved by the trench, there is no need to remove the dummy portion 432. This is another advantage of the present invention.

After forming the trench 420 pattern on the conductive layer 412, when an overly wide dummy portion 432 is formed in the lower part covered with the insulating layer 416, a dummy portion is formed to prevent part of the insulating layer 416 from sinking to the bottom. Portion 432 may remain intact without being removed.

Trench 420 may include an inner trench 420a or an edge trench 420b. The internal trench 420a may insulate the conductive islands 430 from each other. The internal trench 420a may be disposed at least one of the electrodes 424, the leads 426, and the sensor pads 428.

Meanwhile, when the conductive layer 412 is exposed to the edge of the electrochemical sensor 400, the insulation deteriorates, so it is necessary to prevent side exposure of the conductive layer 412. After the conductive layer 412 is laminated, a portion of the conductive layer 412 may be cut along the edge of the electrochemical sensor 400. This is the edge trench 420b. Therefore, an insulating layer 416 is attached to the edge of the electrochemical sensor 400 on the base layer 410 and can be insulated. An insulating layer 416 may be attached to the inner edge of the electrochemical sensor 400 on the conductive layer 412 stacked on the base layer 410.

Edge trench 420b may form the outermost edge of conductive layer 412. The edge trench 420b may serve to insulate the conductive island 430 located at the outermost part of the electrochemical sensor 400 from the outside of the sensor 400. When the electrochemical sensor 400 is processed as an array, the edge trench 420b can prevent short circuits between adjacent sensors 400 or spaced apart adjacent conductive islands 430 from occurring.

The width W1 of the inner trench 420a and the width W2 of the edge trench 420b may range from 5 to 30 ㎛.

Figure 4 (a) may be a case where a plurality of internal trenches 420a are formed between the conductive islands 430, and Figure 4 (b) may be a case where a single internal trench 420a is formed between the conductive islands 430. It may be the case that it was formed.

Figure 5(a) may be a case where a plurality of internal trenches 420a are formed between the leads 426 disposed in the middle portion 404, and Figure 5(b) may be a case where a single trench 420a is formed between the leads 426. This may be the case where the internal trench 420a is formed.

A trench 420 may be formed in the conductive layer 412 by laser etching, which removes a portion of the conductive layer 412 with a laser irradiated to the conductive layer 412. A plurality of conductive islands 430 separated from each other may be formed in the conductive layer 412 by the trench 420.

A conductive island 430 on which electrodes 424 and sensor pads 428 are formed in the conductive layer 412 by the trench 420, or a dummy portion all covered with an insulating layer 416 so that no part is exposed to the outside. It may include (432).

A dummy portion 432 may be provided between the first conductive island 430a and the second conductive island 430b, and the first internal trench 420a' and the second internal trench 420a'' may be located. You can.

Accordingly, a dummy portion 432 and at least one trench 420 may be formed between the conductive islands 430.

In this case, short circuit between the conductive islands 430 finely engraved by the dummy portion 432 can be prevented. Even if a short circuit occurs in the electrochemical sensor 400 and the conductive island 430 is short-circuited with the adjacent dummy portion 432, a short circuit between adjacent conductive islands 430 is prevented, thereby reducing the probability of a measurement error occurring.

The plurality of conductive islands 430 may share the trench 420 located between the plurality of conductive islands 430. In this case, the dummy portion 432 may not be provided between the first conductive island 430a and the second conductive island 430b, and one internal trench 420a may be located. Because adjacent conductive islands are electrically separated by a shared internal trench 420a, the electrochemical sensor 400 can be minimized by reducing the width and width of the proximal portion 402 or the width and width of the distal portion 406. You can.

FIG. 5(a) may be an enlarged portion of FIG. 4(a), and FIG. 5(b) may be an enlarged portion of FIG. 4(b).

The effect on the trench 420 structure of FIG. 5 can be applied in the same way as the effect on the trench 420 structure of FIG. 4 .

In (a) of FIG. 5 , the dummy portion 432 can prevent short circuits between leads 426a and 426b formed with a fine width. Even if a short circuit occurs in the electrochemical sensor 400, the leads 426a and 426b are short-circuited with the adjacent dummy portion 432, and short-circuiting between adjacent leads can be prevented, thereby reducing the probability of a measurement error occurring.

In (b) of FIG. 5, adjacent leads 426a and 426b are electrically separated by a shared internal trench 420a, so the width and width of the middle portion 404 can be reduced.

The sensor pad 428 may be formed on only one side of the proximal portion 402 or on both sides of the proximal portion 402.

6 illustrates a case where the electrode 424 of the distal portion 406 is formed on both sides, and the sensor pad 428 may be formed on both sides of the proximal portion 402. Each of the double-sided electrodes 424 formed on both sides of the distal part 406 is electrically connected to each sensor pad 428 on both sides of the proximal part 402 along the leads 426 formed on both sides of the middle part 404. can be connected In this case, the via hole 411 for electrically connecting the conductive layer 412 formed on one side of the base layer 410 and the conductive layer 412 formed on the other side of the base layer 410 may not need to be formed. there is.

Meanwhile, if the sensor pad 428 is formed on both sides of the proximal portion 402, it may be difficult to electrically connect it to the contact pad of the main board 202 using a simple alignment method. For example, a separate connector portion may be needed to insert or sandwich the proximal portion 402, or a mutual cross-cross structure to energize the sensor pad 428 and the contact pad.

Accordingly, the sensor pad 428 may be formed only on one side of the proximal portion 402.

7 to 10 may illustrate embodiments where the sensor pad 428 is formed only on one surface of the proximal portion 402.

The sensor pad 428 disposed on one surface of the proximal portion 402 may be disposed to be fully exposed in the first direction. The contact pads of the main board 202 may be arranged to be fully exposed in the second direction. The first direction and the second direction may be 180 degrees opposite to each other. Accordingly, the sensor pad 428 faces the contact pad and may be electrically connected to each other.

By the via hole 411, the first conductive island formed on one side of the base layer 410 and the second conductive island formed on the other side of the base layer 410 may be electrically connected to each other. By the first conductive island and the second conductive island, at least one of the sensor pads 428 on one side and the other side, the lead 426 on the one side and the other side, and the electrode 424 on the one side and the other side are electrically connected to each other. can be connected

The via hole 411 may include a first via hole 411a and a second via hole 411b.

The first via hole 411a may be blocked from the outside by an insulating layer 416.

When a part of the distal portion 406 is invaded into the body and an oxidation/reduction reaction occurs between the electrode 424 and the analyte in the body, the electrochemical sensor 400 of the present invention continuously performs analysis while being invaded by the analyte in the body. , the first via hole 411a formed to finely penetrate the base layer 410 is prone to contamination due to continued reaction with various substances in the body. Accordingly, the first via hole 411a is blocked from contact with the outside by the insulating layer 416, thereby reducing contamination due to electrochemical reaction.

At least one of both sides of the second via hole 411b may be exposed to the outside.

The second via hole 411b may be provided on the electrode 424 of the distal part 406 or the sensor pad 428 of the proximal part 402 that is exposed to the outside.

The via hole 411 may be formed in at least one of the proximal part 402, the middle part 404, and the distal part 406.

7 and 8 show a first embodiment in which the via hole 411 is formed in the base layer 410, and may be a case in which the via hole 411 is formed in the proximal portion 402.

FIG. 7 may be a side view of the first embodiment, FIG. 8 (a) may be a top view of the first embodiment, and FIG. 8 (b) may be a rear view of the first embodiment.

FIG. 9 shows a second embodiment in which the via hole 411 is formed in the base layer 410, which may be a case in which the via hole 411 is formed in the distal portion 406.

FIG. 9 (a) may be a side view of the second embodiment, FIG. 9 (b) may be a top view of the second embodiment, and FIG. 9 (c) may be a rear view of the second embodiment.

Figure 10(a) may schematically show the connection relationship of the first embodiment, and Figure 10(b) may schematically show the connection relationship of the second embodiment.

The first embodiment in which the via hole 411 is formed in the proximal part 402 and the second embodiment in which the via hole 411 is formed in the distal part 406 are for convenience of explanation, and the via hole 411 is formed as necessary. It may be formed overlapping in the proximal part 402, the middle part 404, or the distal part 406. Accordingly, the content discussed regarding the via holes 411 can be expanded in various ways depending on the number and arrangement of the sensor pads 428, the number and arrangement of the electrodes 424, or the number and arrangement of the via holes 411.

In the first embodiment, a via hole 411 penetrating the base layer 410 may be provided in the proximal portion 402.

A first electrode exposed in the first direction may be formed on the first surface of the distal part 406, and a second electrode exposed in the second direction may be formed on the second surface of the distal part 406. The first direction and the second direction may be opposite directions. All sensor pads 428 may be formed on the first surface of the proximal portion 402 to be exposed in the first direction.

By the via hole 411, the second electrode on the second side may be electrically connected to the sensor pad 428 on the first side in a one-to-one correspondence.

When the via hole 411 is formed in the proximal part 402, the electrode 424 can be placed on both sides of the distal part 406, which increases the reactivity between the analyte in the body and the electrode 424 and allows the electrode 424 to Since the placement area can be reduced, the size of the distal part 406 can be manufactured to be small.

Since the part of the electrochemical sensor 400 that is inserted into the body is the distal part 406, if the size of the distal part 406 is minimized, pain and foreign body sensation felt by the user can be reduced. Since the continuous analyte measuring device of the present invention is not for intermittent and temporary measurement, but is for continuous measurement for a predetermined period of time while invasive or attached to the body, minimizing the distal portion 406 is important.

The leads 426 connected to the plurality of electrodes 424 can also be distributed and disposed on both sides of the middle portion 424, which has the effect of reducing the width of the middle portion 424 compared to the number of electrodes 424 formed. can be given.

The effect of reducing the size of the distal part 406 and the width of the middle part 424 can be similarly applied when the via hole 411 is formed in the distal part 406.

According to the present invention, when measuring an analyte, the transmitter 200 may be attached to the skin, the proximal portion 402 may be connected to the contact pad of the transmitter 200, and at least a portion of the distal portion 406 may be invaded into the body. there is. When measuring an analyte in an invasive state, the electrochemical sensor 400 needs to be maintained in a flexible bent state at the folded portion 405 of the middle portion 424. Therefore, it may be advantageous for the measurement stability of the electrochemical sensor 400 to have a narrow width of the middle portion 424.

If the sensor pad 428 is disposed to be exposed only on one side of the proximal portion 402, the width may be increased. However, since the sensor pad 428 of the proximal part 402 is electrically connected to the contact pad of the transmitter 200, there may be no problem even if the sensor pad 428 is longer than the distal part 406 that invades the body.

When the via hole 411 is formed in the proximal part 402, various types of electrodes may be arranged so that the plurality of electrodes 424 provided in the distal part 406 have different functions. That is, the electrodes 424 disposed on the same side of the distal portion 406 may each have different functions, and the electrodes 424 disposed on both sides of the distal portion 406 may each have different functions.

When the via hole 411 is formed in the proximal portion 402, both one side and the other side of the first via hole 411a are blocked from contact with the outside by the insulating layer 416, thereby preventing contamination. One end of the second via hole 411b may be exposed to the outside through the proximal opening 422a, and the other end of the second via hole 411b may be blocked from contact with the outside by the insulating layer 416.

Specifically, in the first embodiment, first electrodes 424a to fourth electrodes 424d may be provided, first sensor pads 428a to fourth sensor pads 428d may be provided, and electrodes And first leads 426a to fourth leads 426d connecting the sensor pads may be provided. A first electrode 424a and a second electrode 424b may be formed on the first side of the base layer 410, and a third electrode 424c and a fourth electrode (424c) may be formed on the second side of the base layer 410. 424d) may be formed.

The first electrode 424a may be electrically connected to the second sensor pad 428b along the first lead 426a provided on the first surface of the base layer 410, and the second electrode 424b may be connected to the base layer 410. It may be electrically connected to the fourth sensor pad 428d along the second lead 426b provided on the first surface of 410.

The third electrode 424c may be connected to the proximal portion 402 along the third lead 426c provided on the second surface of the base layer 410, and the fourth electrode 424d may be connected to the first lead 426c of the base layer 410. It may be connected to the proximal part 402 along the fourth lead 426d provided on two sides.

The third electrode 424c may be electrically connected to the third sensor pad 428c disposed on the first surface through the via hole 411 of the proximal portion 402, and the fourth electrode 424d may be electrically connected to the third sensor pad 428c of the proximal portion 402. It may be electrically connected to the first sensor pad 428a disposed on the first surface through the via hole 411.

The first lead 426a and the second lead 426b may be formed on the first surface of the base layer 410 so as not to cross each other, and the third lead 426c and the fourth lead 426d may not cross each other. It may be formed on the second side of the base layer 410.

In the first embodiment, the selective transmission layer 418 may be provided as many as the number of electrodes 424. The same type of selective transmission layer 418 may be applied to the same type of electrode. In FIG. 7, if the types of the first electrodes 424a to 424d are different, the first selectively transparent layers 418a to 418d applied to each electrode may also be different. .

In the second embodiment, a via hole 411 penetrating the base layer 410 may be provided in the distal portion 406.

A first electrode exposed in the first direction may be formed on the first surface of the distal part 406, and a second electrode exposed in a second direction opposite to the first direction may be formed on the second surface of the distal part 406. It can be.

When the via hole 411 is formed in the distal portion 406, the first electrode and the second electrode can be electrically connected by the via hole 411. The first electrode and the second electrode may be provided as the same type of electrode, one of a working electrode, a reference electrode, and a counter electrode.

Accordingly, the via hole 411 of the distal part 406 allows electrodes with the same function to be placed on both sides of the distal part 406, so that the direction in which the electrochemical sensor 400 is inserted into the body, or the electrochemical sensor 400 Measurement instability due to the arrangement relationship between the needle 300 and the distal portion 406, which guides insertion into the body, can be reduced.

When the via hole 411 is formed in the distal part 406, the lead 426 and the sensor pad 428 may be formed only on the first side of the base layer 410, and the electrode 424 in the distal part 406 The excluded second side of the middle portion 424 or the proximal portion 424 may be surrounded by an insulating layer 416 and blocked from contact with the outside. Since there is no need to provide complex leads 426 on both sides of the thin electrochemical sensor 400, the stability of electric flow throughout the electrochemical sensor 400, including short circuits between leads, can be improved.

When the via hole 411 is formed in the distal portion 406, both one side and the other side of the first via hole 411a are blocked from contact with the outside by the insulating layer 416, thereby preventing contamination. One end and the other end of the second via hole 411b may be exposed to the outside through the distal opening 422b.

By the second via hole 411b, the electrode on one side of the base layer 411 and the electrode on the other side of the base layer 411 can be placed and connected to the same electrode type, thereby improving the directionality of the invaded distal portion 406. Regardless, electrochemical reactivity between the electrode 424 and the reactant can be increased.

Specifically, in the second embodiment, first electrodes 424a to fourth electrodes 424d may be provided, first sensor pads 428a to fourth sensor pads 428d may be provided, and electrodes And first leads 426a to fourth leads 426d connecting the sensor pads may be provided.

A first electrode 424a and a second electrode 424b may be formed on the first side of the base layer 410, and a third electrode 424c and a fourth electrode (424c) may be formed on the second side of the base layer 410. 424d) may be formed.

The first electrode 424a may be electrically connected to the second sensor pad 428b along the first lead 426a provided on the first surface of the base layer 410, and the second electrode 424b may be connected to the base layer 410. It may be electrically connected to the first sensor pad 428a along the second lead 426b provided on the first surface of 410. The fifth electrode 424e may be electrically connected to the third sensor pad 428c along the third lead 426c provided on the first surface of the base layer 410. The present invention may include a manufactured dummy electrode such as the fifth electrode 424e, and in the case of the dummy electrode, the selective transmission layer 418 for reaction with the analyte in the body may not be applied.

The third electrode 424c disposed on the second side of the base layer 410 may be electrically connected to the first electrode 424a disposed on the first side of the base layer 410 through the via hole 411, The fourth electrode 424d disposed on the second side of the base layer 410 may be electrically connected to the second electrode 424b disposed on the first side of the base layer 410 through the via hole 411. In this case, the first electrode 424a and the third electrode 424c may be the same type of electrode, and the second electrode 424b and the fourth electrode 424d may be the same type of electrode.

The first lead 426a and the second lead 426b may be formed on the first side of the base layer 410 so as not to intersect each other. When the via hole 411 is formed in the distal portion 406, the number of leads 426 or sensor pads 428 may be less than the number of electrodes 424.

Unlike the first embodiment, in the second embodiment, the electrodes are connected to each other through the via hole 411, so the selective transmission layer 418 applied to the electrodes on one side and the other side connected by the via hole 411 may be the same. . For example, the first electrode 424a and the third electrode 424c may be connected by a via hole 411, and the same first selective transmission layer 418a may be applied to the first electrode 424a and the third electrode 424c. ) can be applied.

Referring to FIG. 11, the manufacturing method of the electrochemical sensor 400 of the present invention will be described overall.

The electrochemical sensor manufacturing method includes a conductive layer step of laminating a conductive layer 412 on the flexible base layer 410 of the electrochemical sensor 400, and an insulating layer of attaching an insulating layer 416 to the conductive layer 412. May include layer steps.

The electrochemical sensor manufacturing method may include a via hole step in which a via hole 411 penetrating the base layer 410 is formed.

The via hole 411 may be formed using a laser or mechanical method. The via hole 411 may be formed by a laser etching method that removes a portion of the base layer 410 by irradiating a laser from the laser head 490 to the base layer 410.

The via hole step may be performed before the conductive layer step. Formation of the conductive layer can be performed by physical vapor deposition including sputtering.

The via hole 411 may include a first via hole 411a and a second via hole 411b.

The first via hole 411a may be blocked from the outside by the insulating layer 416, and at least one of both sides of the second via hole 411b may be exposed to the outside.

The conductive layer step includes a first conductive layer step of forming the conductive layer 412 on one side of the base layer 410, and a second conductive layer step of forming the conductive layer 412 on the other side of the base layer 410. can do.

By the first conductive layer step and the second conductive layer step, the conductive layer 412 is formed into an identical layer that is seamlessly continuous along the top surface of the base layer 410, the surface of the via hole 411, and the back surface of the base layer 410. It can be laminated with metal materials.

This aspect of the present invention is to stack a plurality of layers corresponding to the number of electrodes 424 or the number of sensor pads 428 in order to form the electrodes 424 or sensor pads 428 on the base layer 410. This may be a difference from other technologies. When stacking a plurality of layers corresponding to the number of poles 424 or the number of sensor pads 428 on the electrochemical sensor 400 in which the via hole 411 is formed, several layers are formed around the via hole 411. Seams such as overlapping may occur. When the conductive layer is stacked so that there is a seam such as an overlap, the thickness of the conductive layer around the via hole 411 may be uneven, which may be a factor in increasing the defect rate such as short circuit.

Therefore, the conductive layer of the present invention is one layer or a layer that is the same as one, and may be formed on the inner peripheral surface of the via hole 411, the upper surface of the base layer 410, and the lower surface of the base layer 410, and the via hole 411 ) Short circuit defects such as overlap at both ends can be minimized, and the conduction defect rate of the via hole 411 itself can also be reduced.

In the insulating layer stage, the first via hole 411a may face the insulating layer 416, and the second via hole 411b may face the opening 422 of the insulating layer 416.

The insulating layer 412 may be adhered on the conductive layer 412 with an opening 422 penetrating the insulating layer 412 formed in the insulating layer stage. The electrode 424 may be exposed to the outside through the opening 422 and react with the analyte in the body. Electrodes 424 may be formed on both sides of the distal portion 406.

The electrochemical sensor manufacturing method may include a trench step in which a trench 420 is formed in the conductive layer 412.

The trench 420 may be formed by laser etching, which removes a portion of the conductive layer 412 with a laser irradiated to the conductive layer 412.

If necessary, a heat treatment step may be performed after the conductive layer step or the insulating layer step.

The electrochemical sensor manufacturing method may include a selectively transparent layer step of applying a selectively transparent layer 418 to the opening 422 of the insulating layer 416 by dispensing or the like.

The material of the selective transmission layer 418 may be determined depending on the type of analyte in the body that is to electrochemically react with the electrode 424. For example, in the selectively transparent layer step, a selectively transparent layer containing platinum may be applied to the working electrode, and a selectively transparent layer containing silver chloride may be applied to the reference electrode.

After the selective transmission layer step, a coating process such as a membrane may be additionally performed on the electrochemical sensor 400.

100... inserter 102... driving unit
200... transmitter 202... main board
300... needle 310... needle handle
400... electrochemical sensor 402... proximal
404... middle part 405... folded part
406... distal 410... basal layer
411... via hole 411a... first via hole
411b... second via hole 412... conductive layer
414...bonding layer 416...insulating layer
418... selectively transparent layer 418a... first selectively transparent layer
418b... second selectively transparent layer 418c... third selectively transparent layer
418d... fourth selectively transparent layer 420... trench
420a... internal trench 420a'... first internal trench
420a''... second inner trench 420b... edge trench
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
426a... first lead 426b... second lead
426c... 3rd lead 426d... 4th lead
428... sensor pad 428a... first sensor pad
428b... second sensor pad 428c... third sensor pad
428d... fourth sensor pad 430... conductive island
430a... first conductive island 430b... second conductive island
430c... third conductive island 432... dummy portion
432a... first dummy portion 432b... second dummy portion
490...laser head W1,W2...trench width

Claims (21)

An electrochemical sensor including a distal part formed with a plurality of electrodes that react with analytes in the body, a proximal part formed with a sensor pad connected to the electrodes, and an intermediate part located between the distal part and the proximal part;
A transmitter including a main board on which at least one of a power supply unit, a communication unit, and a control unit is formed, a housing in which the main board is stored, and attached to the skin; Including,
The distal portion of the electrochemical sensor is disposed in an exposed portion along the longitudinal direction of the needle,
After the skin is incised by the needle, the distal portion of the electrochemical sensor is inserted into the body,
The electrochemical sensor is a continuous analyte meter including a flexible base layer, a conductive layer laminated on the base layer, and an insulating layer attached on the conductive layer.
According to claim 1,
The insulating layer is adhered on the conductive layer with an opening penetrating the insulating layer,
The electrode is exposed to the outside through the opening,
A continuous analyte measuring device in which the electrodes are formed on both sides of the distal portion.
According to claim 1,
A via hole penetrating the base layer is provided,
A continuous analyte measuring device in which the via hole is formed by a laser etching method that removes a portion of the base layer by irradiating a laser to the base layer.
According to claim 1,
The conductive layer is formed on both sides of the base layer by sputtering metal on the base layer.
According to claim 1,
A via hole is formed by cutting a portion of the base layer,
The conductive layer is a continuous analyte measuring device in which the conductive layer is laminated with the same metal material seamlessly along the top surface of the base layer, the surface of the via hole, and the back surface of the base layer.
According to claim 1,
The sensor pad is formed only on one surface of the proximal portion,
The sensor pad and contact pad are each exposed in the same direction,
A continuous analyte measuring device in which the sensor pad and the contact pad face each other and are electrically connected.
According to claim 1,
A via hole penetrating the base layer is provided,
By the via hole, the conductive layers laminated on both sides of the base layer are electrically connected to each other,
The via hole is formed in at least one of the proximal part, the middle part, and the distal part.
According to claim 1,
A plurality of conductive islands separated from each other are formed in the conductive layer by laser etching, which removes a portion of the conductive layer with a laser irradiated to the conductive layer,
A via hole penetrating the base layer is provided,
A continuous analyte measuring device in which a first conductive island formed on one side of the base layer and a second conductive island formed on the other side of the base layer are electrically connected to each other by the via hole.
According to claim 1,
A via hole penetrating the base layer is provided,
The via hole includes a first via hole and a second via hole,
The first via hole is blocked from the outside by the insulating layer,
The second via hole is a continuous analyte measuring device in which at least one of both sides is exposed to the outside.
According to claim 1,
A via hole penetrating the base layer is provided in the proximal portion,
A first electrode exposed in a first direction is formed on a first surface of the distal part, and a second electrode exposed in a second direction is formed on a second surface of the distal part,
The first direction and the second direction are opposite directions,
All sensor pads are formed on the first surface of the proximal portion to be exposed in the first direction,
A continuous analyte measuring device in which the second electrode on the second side is electrically connected to the sensor pad on the first side in a one-to-one correspondence with the sensor pad on the first side through the via hole.
According to claim 1,
A via hole penetrating the base layer is provided at the distal portion,
A first electrode exposed in a first direction is formed on the first surface of the distal portion,
A second electrode exposed in a second direction opposite to the first direction is formed on the second surface of the distal portion,
The first electrode and the second electrode are electrically connected by the via hole,
The first electrode and the second electrode are of the same type, one of a working electrode, a reference electrode, and a counter electrode.
According to claim 1,
A plurality of leads are provided in the middle portion to connect the electrode and the sensor pad,
The plurality of leads are formed by a laser etching method in which a portion of the base layer is removed by irradiating a laser to the base layer,
A continuous analyte measuring device in which each lead is intersected and placed so as not to be twisted.
According to claim 1,
A trench is formed in the conductive layer by laser etching, which removes a portion of the conductive layer with a laser irradiated to the conductive layer,
A plurality of conductive islands separated from each other are formed in the conductive layer by the trench,
The plurality of conductive islands share a trench located between the plurality of conductive islands.
According to claim 1,
A trench is formed in the conductive layer by laser etching, which removes a portion of the conductive layer with a laser irradiated to the conductive layer,
By the trench, the conductive layer includes a conductive island on which the electrode and sensor pad are formed, and a dummy portion completely covered with the insulating layer so that no portion is exposed to the outside,
A continuous analyte measuring device in which the dummy portion and at least one trench are formed between the conductive islands.
A continuous analyte measuring device that continuously measures analytes in the body includes an electrochemical sensor and a transmitter attached to the skin together with the electrochemical sensor,
The electrochemical sensor includes a distal part formed with a plurality of electrodes that react with analytes in the body, a proximal part formed with a sensor pad connected to the electrodes, and an intermediate part located between the distal part and the proximal part,
The transmitter includes a main board on which at least one of a power source, a communication part, and a control part is formed, and a housing in which the main board is stored,
A conductive layer step of laminating a conductive layer on the flexible base layer of the electrochemical sensor;
an insulating layer step of attaching an insulating layer to the conductive layer; An electrochemical sensor manufacturing method comprising.
According to claim 15,
In the insulating layer step, the insulating layer is adhered on the conductive layer with an opening penetrating the insulating layer formed,
The electrode is exposed to the outside through the opening,
A continuous analyte measuring device in which the electrodes are formed on both sides of the distal portion.
According to claim 15,
It includes a via hole step in which a via hole penetrating the base layer is formed,
The via hole step is performed before the conductive layer step,
An electrochemical sensor manufacturing method in which the via hole is formed by a laser etching method in which a portion of the base layer is removed by irradiating a laser to the base layer.
According to claim 15,
It includes a via hole step in which a via hole penetrating the base layer is formed,
The conductive layer step includes a first conductive layer step of forming a conductive layer on one side of the base layer, and a second conductive layer step of forming a conductive layer on the other side of the base layer,
By the first conductive layer step and the second conductive layer step, the conductive layer is laminated with the same metal material seamlessly along the top surface of the base layer, the surface of the via hole, and the back surface of the base layer. Manufacturing method.
According to claim 15,
A trench step in which a trench is formed in the conductive layer,
An electrochemical sensor manufacturing method in which the trench is formed by laser etching to remove a portion of the conductive layer with a laser irradiated to the conductive layer.
According to claim 15,
It includes a via hole step in which a via hole penetrating the base layer is formed,
The via hole includes a first via hole and a second via hole,
The first via hole is blocked from the outside by the insulating layer,
At least one of both sides of the second via hole is exposed to the outside,
In the insulating layer step, the insulating layer is adhered on the conductive layer with an opening penetrating the insulating layer 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.
According to claim 15,
In the insulating layer step, the insulating layer is adhered on the conductive layer with an opening penetrating the insulating layer formed,
A selective transmissive layer step of applying a selective transmissive layer to the opening; Includes,
An electrochemical sensor manufacturing method in which the material of the selective transmission layer is determined depending on the type of analyte in the body that is to electrochemically react with the electrode.

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