KR20240036389A - Continuous analyte device with electrochemical sensor with electrodes formed on both sides - 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. sensor. It may include 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 a transmitter attached to the skin.
The electrochemical sensor of the present invention may include a flexible base layer, a conductive layer laminated on the base layer, and an insulating layer attached on the conductive layer. The electrode closer to the end of the distal part may be called the front electrode, and the electrode less close to the end of the distal part than the front electrode may be called the back electrode, and the most anterior electrode may be the one closest to the end of the distal part among the front electrodes. Can be provided on both sides of the distal part.

Description

Continuous analyte device with electrochemical sensor with electrodes formed on both sides}

The present invention relates to a continuous analyte measuring device including an electrochemical sensor in which electrodes are formed on both sides of the distal portion, at least part of which penetrates into the body.

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 area of the electrode 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 continuous analyte measuring device of the present invention can provide an embodiment of the distal portion including an electrode, via hole, or lead with improved reactivity with analytes in the body while minimizing the width and length of the distal portion, at least a portion of which is immersed in the body. there is.

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. sensor. It may include 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 a transmitter attached to the skin.

The electrochemical sensor of the present invention may include a flexible base layer, a conductive layer laminated on the base layer, and an insulating layer attached on the conductive layer. The electrode closer to the end of the distal part may be called the front electrode, and the electrode less close to the end of the distal part than the front electrode may be called the back electrode, and the most anterior electrode may be the one closest to the end of the distal part among the front electrodes. Can be provided on both sides of the distal part.

At least one of the front electrode disposed on one surface of the distal portion and the rear electrode adjacent to the front electrode may have a long rectangular shape extending along the longitudinal direction of the distal portion.

The front electrode of the present invention may be formed to completely fill the distal portion along the width direction of the distal portion, and the rear electrode adjacent to the front electrode may be formed not to completely fill the distal portion along the width direction of the distal portion.

At least one of the front electrode of the present invention and the rear electrode disposed to be continuous with the front electrode may be formed to completely fill the distal portion in an elongated rectangular shape extending along the longitudinal direction of the distal portion.

The tightly packed electrode of the present invention may mean an electrode without lead wiring around the electrode along the longitudinal direction of the distal portion, and the width of the tightly packed electrode may be substantially the same as the width of the distal portion.

A lead may not be placed around the frontmost electrode of the present invention, and a lead may be placed around a rear electrode that is continuously placed adjacent to the frontmost electrode.

The width of the anteriormost electrode of the present invention may be substantially equal to the width of the distal portion, and the width of the posterior electrode adjacent to the anteriormost electrode plus the width of the lead disposed around the posterior electrode may be substantially equal to the width of the distal portion. can do.

In addition, the meaning of a fully filled electrode in the present invention may mean that the distal part is completely filled with electrodes, excluding the edge trench, along the width direction of the distal part. The edge trench is formed at the outer edge of the electrochemical sensor and may surround the circumference of the electrode. Along the width direction of the distal portion, the width of the edge trench plus the width of the electrode may be equal to the width of the distal portion.

Along the width direction of the distal part of the front-most electrode, the width of the edge trench plus the width of the front-most electrode may be equal to the width of the distal part, and along the width direction of the distal part of the rear electrode adjacent to the front-most electrode, the edge trench, the front-most electrode. The width of the lead extending backward from the electrode, the width of the internal trench between the lead and the rear electrode, plus the width of the rear electrode may be equal to the width of the distal portion.

The front electrode can be formed to completely fill the distal area without a surrounding lead, thereby increasing the reactivity between the electrode and the analyte. If a lead is formed around the rear electrode adjacent to the front electrode, a via hole may not be formed in the front electrode, and a via hole may be formed in the lead connecting the front electrode to the middle or proximal part of the rear.

The elongated electrode of the present invention may have a plurality of openings in the insulating layer facing each other. In the case of facing a plurality of openings, a selective transmission layer performed by a method such as dispensing can be uniformly applied to the openings, compared to the case of facing a plurality of openings that are elongated to resemble the shape of the electrode.

1 is a perspective view of the combination between an inserter, an electrochemical sensor, and a transmitter of the present invention.
Figure 2 is an explanatory diagram of the trench of the present invention.
Figure 3 is an explanatory diagram of the manufacturing method of the electrochemical sensor of the present invention.
Figure 4 is an embodiment of the distal portion of the present invention.
Figure 5 is a schematic diagram of Figure 4.
Figure 6 is another embodiment of the distal portion of the present invention.
Figure 7 is a schematic diagram of Figure 6.
Figure 8 is another embodiment of the distal portion 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>

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 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 . 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 a reference electrode. 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.

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.

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 may 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. Additionally, the first working electrode and the second working electrode may be complementary to measuring one biomarker. If the first working electrode measures the blood sugar concentration, the second working electrode may measure the concentration of acetaminophen. When taking acetaminophen, the blood sugar level measured in the body may be higher than the actual level, and the blood sugar concentration measured at the first working electrode needs to be judged in consideration of the acetaminophen concentration measured at the second working electrode.

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 sufficient electrode 424 area can be secured 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.

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 and forming a trench 420 by laser etching, etc. may be performed. The formation of the insulating layer 416 and the selectively transparent layer 418 may also be performed simultaneously.

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.

After the conductive layer 412 is deposited on the base layer 410 using a method such as sputtering, a trench 420 may be formed using 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 completely covered by the insulating layer 416.

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

After forming the trench 420 pattern in the conductive layer 412, when a dummy portion that is too wide is formed in the lower part covered with the insulating layer 416, the dummy portion is not removed to prevent part of the insulating layer 416 from sinking to the bottom. It can remain as is.

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.

By the trench 420, the conductive layer 412 is formed with a conductive island 430 on which the electrode 424 and the sensor pad 428 are formed, or a dummy part covered with an insulating layer 416 so that no part is exposed to the outside. It can be included.

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.

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.

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 distal portion 406, the first electrode disposed on the first side of the distal portion 406 by the via hole 411 and the second electrode disposed on the second side of the distal portion 406 are Can be electrically connected. 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.

When electrodes having the same function are disposed on both sides of the distal part 406, the via hole 411 of the distal part 406 is used in the direction in which the electrochemical sensor 400 is inserted into the body, or the direction in which the electrochemical sensor 400 is inserted into the body. Measurement instability due to the arrangement relationship between the guiding needle 300 and the distal portion 406 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.

With reference to FIG. 2, the trench 420 of the present invention will be described.

After the conductive layer 412 is deposited on the base layer 410 using a method such as sputtering, a trench 420 may be formed using 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. Accordingly, 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.

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

Area A in FIGS. 2 and 3 may represent a portion of the edge trench 420b.

Edge trench 420b may form the outermost edge of conductive layer 412.

The edge trench 420b may prevent the conductive layer 412 from protruding to the side of the electrochemical sensor 400. 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 edge trench 420b is created by stacking the conductive layer 412 on the base layer 410 by full-scale sputtering, etc., and then removing the conductive layer 412 at the outer edge of the electrochemical sensor 400 using a laser, etc. You can. All of the conductive layer 410 on the base layer 410 may be cut away, and the base layer 410 may be exposed on the lower surface of the edge trench 420b. Accordingly, the insulating layer 416 or the bonding layer 414 can be directly attached to the edge trench 420b without the conductive layer 412.

A step of the conductive layer 412 may be provided at the edge of the electrochemical sensor 400 by the edge trench 420b.

Referring to FIG. 3, 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 attaching an insulating layer 416 to the conductive layer 412. An insulating layer step may be included.

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. The conductive layer forming step may be performed by a physical vapor deposition method 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 conductive 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.

<Electrode placement>

4 to 8, the arrangement of the electrode 424 and the via hole 411 formed in the distal portion 406 of the present invention will be described.

A lead 426 may be provided to electrically connect the electrode 424 of the distal part 406 and the sensor pad 428 of the proximal part 402.

The sensor pad 428 will be described as an example in which the sensor pad 428 is formed to be exposed only on one side of the proximal portion 402. The fact that the sensor pad 428 is exposed in only one direction may be related to its simple connection with the contact pad formed on the main board 202 of the transmitter 200. The via hole 411 may be used to connect the electrodes 424 disposed on both sides of the distal portion 406 to the sensor pad 428 exposed only on one side of the proximal portion 402.

When the electrodes 424 are disposed on both sides of the distal portion 406, the depth of the distal portion 406 that invades the body may be reduced compared to the case where the electrodes 424 are disposed on only one side of the distal portion. This can relieve the user's pain and foreign body sensation caused by invasion.

The width of the lead 426 may be smaller than the width of the electrode 424 or the width of the sensor pad 428.

The direction of invasion in which the distal part 406 is invaded into the body may coincide with the longitudinal direction of the distal part 406, and the width direction of the distal part 406 or the width direction of the lead 426 may be perpendicular to the direction of invasion. there is.

The lid 426 may be provided in at least one of the proximal part 402, the middle part 404, and the distal part 406.

The middle part 404 is located in the middle of the proximal part 402 and the distal part 406, and electrically connects the sensor pad 428 of the proximal part 402 and the electrode 424 of the distal part 406, so the middle part ( In 404), the electrode 424 and the sensor pad 428 may not be disposed, and only the lead 426 may be disposed. This is because the middle portion 404 needs to remain flexible and bent when the electrochemical sensor 400 is invaded into the body for analyte measurement, and this is to reduce the width of the middle portion 404 or the folded portion 405. It can be. The narrower the width of the middle portion 404 or the folded portion 405, the more the torsional force can be reduced, and fatigue failure can be prevented even if the middle portion 404 or the folded portion 405 is bent and fixed for a considerable period of time. You can.

A location closer to the end of the electrochemical sensor 400 may be referred to as the front, and a location less close to the end of the electrochemical sensor 400 than the front may be referred to as the rear. Alternatively, when an electric path connecting the sensor pad 428 of the proximal part 402 and the electrode 424 of the distal part 406 is formed, a position closer to both ends of the electric path is forward, and a position less close to both ends of the electric path than the front. can be called the rear.

The lead 426 may be placed around the rear electrode such that the front electrode of the distal part 406 is electrically connected to the middle part 404 or the proximal part 402, or may be placed alone rather than around the electrode.

The lead 426 disposed on one side of the rear electrode may extend in parallel along the longitudinal direction of the distal portion 406 together with the rear electrode. When the lead 426 is disposed alone, the lead 426 may be connected to the electrode 424 located at the rearmost part of the distal portion 406.

At least one electrode 424 may be provided on both sides of the distal portion 406.

The width of the electrode 424 may not change along the longitudinal direction of the distal portion 406.

The electrode closer to the end of the distal portion 406 may be referred to as the front electrode, and the electrode less close to the end of the distal portion than the front electrode may be referred to as the rear electrode. The most anterior electrode may mean the one closest to the distal end of the anterior electrodes.

The terms anterior electrode, posterior electrode, and most anterior electrode described below refer to the position of the electrode 424 disposed in the distal portion 406, and mean that at least two electrodes, the anterior electrode and the posterior electrode, are necessarily disposed on both sides. No.

At least one of the front electrode and the rear electrode disposed to be continuous with the front electrode may be formed to completely fill the distal portion 406 in a long rectangular shape extending along the longitudinal direction of the distal portion 406.

A fully filled electrode may mean an electrode without lead 426 wiring around the electrode 424 along the length direction of the distal part 406, and the width of the fully filled electrode 424 is equal to the width of the distal part 406. may be substantially the same.

Additionally, fully filling the electrode may mean that the electrode 424 is formed along the width direction of the distal portion 406 except for the edge trench 420b. The width of electrode 424, plus edge trench 420b, may match the width of distal portion 406.

The lead 426 may not be placed around the front-most electrode, and the lead 426 may be placed around the rear electrode that is continuously placed adjacent to the front-most electrode.

The front electrode may be formed to completely fill the distal portion 406, and the rear electrode adjacent to the front electrode may be formed not to completely fill the distal portion 406.

Along the width direction of the distal portion 406 of the back electrode adjacent to the frontmost electrode, an edge trench 420b, the width of the lead 426 extending rearward from the frontmost electrode, and an internal trench 420a between the lead 426 and the back electrode. ), plus the width of the rear electrode, may be equal to the width of the distal portion 406.

The front electrode can be formed to completely fill the area of the distal portion 406 without the surrounding lead 426, thereby increasing the reactivity between the electrode 424 and the analyte in the body. If the lead 426 is formed around the rear electrode adjacent to the front electrode, the via hole 411 may not be formed in the front electrode, and the via hole 411 may be formed in the lead 426 extending backward from the front electrode. You can.

When the via hole 411 is formed in the base layer 410 corresponding to the first front electrode on the first side of the distal portion 406, the second front electrode and the first front electrode on the second side of the distal portion 406 are It may be electrically connected, and the first foremost electrode and the second foremost electrode may be composed of the same type of electrode. In order to configure the front electrodes on both sides of the distal portion 406 with different types of electrodes, the via hole 411 may not be formed in the base layer 410 facing the front electrode, and the front electrode may be formed backward from the front electrode. It may be connected to the middle portion 404 or the proximal portion 402 along the lead 426. The via hole 411 may be formed in the lead 426 connecting the middle portion 404 or the proximal portion 402 located behind the frontmost electrode. The via hole 411 formed in the lead 426 may be formed at a position of the distal part 406 past the rear electrode adjacent to the front electrode, or may be formed in the middle part 404.

A first edge trench may be formed on one side of the distal portion 406, and a second edge trench may be formed on the other side of the distal portion 406. Along the width direction of the distal portion 406, the first edge trench, the electrode 424, and the second edge trench may be arranged in this order. The width of the first edge trench, the width of the electrode 424, and the width of the second edge trench plus the width of the distal portion 406 may be equal to the width of the distal portion 406.

The first edge trench, the electrode 424, and the second edge trench are arranged in that order along the width direction of the distal portion 406, and may be provided in at least two places along the longitudinal direction of the distal portion 406, It may be provided on different electrodes 424.

An opening 422 may be formed in the insulating layer 416 to expose a portion of the electrode 424 to the outside. The insulating layer 416 may be adhered onto the conductive layer 416 with the opening 422 penetrating the insulating layer 416 formed. Each electrode 424 may be electrically separated from each other by a trench 420 and insulated from each other.

A selectively transparent layer 418 may be applied to the opening 422. 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.

The electrode 424 may react with an analyte in the body through the opening 422. Since one electrode 424 is electrically connected, the same selective transmission layer 418 can be applied to the plurality of openings 422 formed in one electrode 424.

Different types of selective transmission layers 418 may be applied to each opening 422 formed corresponding to each electrode 424. A first opening 423a may face the first electrode 424a, and a first selective transmission layer 418a may be applied to the first opening 423a. The same applies to the second electrodes 424b to 5th electrodes 424e, the second openings 423b to 5th openings 423e, and the second selective transmission layers 418b to 5th selective transmission layers 418e. You can.

A portion of the electrode 424 may be exposed to the outside through the opening 422 of the insulating layer 416. If the via hole 411 is located in the base layer 410 corresponding to the opening 422, the flow of the solution can be improved and the reactivity between the analyte in the body and the electrode 424 can be increased.

A plurality of openings 422 may be formed along the longitudinal direction of the distal portion 406 in at least one of the frontmost electrode and the rear electrode continuously disposed on the frontmost electrode. In this way, the electrode extending along the longitudinal direction of the distal portion 406 and forming a plurality of openings 422 may be referred to as a merge electrode. Conversely, electrodes that do not extend along the longitudinal direction of the distal portion 406 may be referred to as split electrodes. The split electrode may be large enough to form a single circular opening 422 compared to the merged electrode.

The reference electrode may be disposed on the split electrode, and due to the nature of the reference electrode, it may be sufficient to have one opening 422 disposed.

The length of the distal portion 406 of the merged electrode along the invasion direction may be within 2 to 20 times the length of the distal portion 406 of the split electrode along the invasion direction.

Since at least a portion of the distal portion 406 is inserted into the body, the distal portion 406 may be long in the insertion direction and needs to be thin. Accordingly, the distal portion 406 may have a flat rectangular parallelepiped shape, and the cross-section of the electrode 424 formed on the distal portion 406 may have a rectangular shape. The merged electrode may have a rectangular shape extending long along the longitudinal direction of the distal portion 406.

The merge electrode may have a selective transmission layer 418 applied to the opening 422 using a method such as dispensing. When the selective transmission layer 418 is applied to the opening 422 in the shape of a spherical water droplet during the dispensing process, the uniformity of application may be reduced in the single rectangular opening 424, so that a plurality of circular openings 422 are formed. There may be frequent cases where it faces the electrode 424. In the drawings of the present invention, a case in which a plurality of circular openings 422 are formed in the merge electrode is described, but a case in which only one large rectangular opening 422 similar to the merge electrode is formed may also be included.

The merged electrode may be an electrode in which a plurality of openings are provided along the longitudinal direction of the distal portion among the frontmost electrode and the rear electrode continuously disposed on the frontmost electrode.

The merging electrode may be either a working electrode or a counter electrode. The electrode that mainly reacts with the analyte in the body may be the working electrode, and in order to maximize the reactivity with the analyte, it is necessary to secure the maximum area of the working electrode.

A first front electrode, which is the frontmost electrode of the first side, and a first rear electrode adjacent to the first front electrode may be provided on the first side of the distal portion 406, and on the second side of the distal portion 406, A second front electrode, which is the front electrode of the second surface, and a second rear electrode continuously disposed on the second front electrode may be provided.

The lead 426 may not be formed along the longitudinal direction of the distal portion 406 around the first most front electrode on the first side and around the second most front electrode on the second side. Leads 426 may be formed around the first rear electrode and around the second rear electrode.

The width of the first foremost electrode plus the width of the edge trench 420b and the width of the second foremost electrode plus the width of the edge trench 420b may be equal to the width of the distal portion 406 .

The width of the first rear electrode, the width of the edge trench 420b, and the width of the lead 426 connected from the first most anterior electrode and formed around the first rear electrode may be equal to the width of the distal portion 406. there is. Likewise, the width of the second rear electrode, the width of the edge trench 420b, and the width of the lead 426 connected from the second most anterior electrode and formed around the second rear electrode, plus the width of the distal portion 406, are equal to the width of the distal portion 406. It can be the same.

An internal trench 420a may be provided to insulate the second rear electrode and the lead 426 formed around the second rear electrode from each other.

The internal trench 420a may function to insulate the objects formed in the electrochemical sensor 400 from each other. By the internal trench 420a, the lead 426 and the electrode 424 may be separated and insulated from each other.

When the lead 426 is formed around the first rear electrode, an internal trench 420a that separates the lead 426 and the first rear electrode from each other may be disposed between the lead 426 and the first rear electrode. . Likewise, when the lead 426 is formed around the second rear electrode, an internal trench 420a that separates the lead 426 and the second rear electrode from each other will be disposed between the lead 426 and the second rear electrode. You can.

The width of the first rear electrode, the width of the edge trench 420b, the width of the lead 426 formed around the first rear electrode, and the width of the inner trench 420a plus the width of the distal portion 406 is equal to the width of the distal portion 406. can do.

Likewise, the width of the second rear electrode, the width of the edge trench 420b, the width of the lead 426 formed on the second rear electrode, and the width of the inner trench 420a plus the width of the distal portion 406 is equal to the width of the distal portion 406. can do.

Among the electrodes 424, an electrode that electrically connects the electrodes 424 without forming an opening 422 may be referred to as a dummy electrode. The dummy electrode may have no opening 422 and all contact with the outside is blocked by the insulating layer 416. A dummy electrode may be included in the dummy portion 432.

The dummy electrode may provide a bypass path that allows the electrode on the first side of the distal portion 406 to be energized back to the first side through the electrode on the second side of the distal portion 406.

The dummy electrode can increase the rigidity, such as maintaining the appearance of the electrochemical sensor 400.

The rear electrode and the leads extending backward from the front electrode may be spaced apart from each other.

A dummy electrode that does not face the lead or the opening of the insulating layer may be disposed between the mutually spaced rear electrode and the lead extending backward from the front electrode. This lead or dummy electrode may function to provide an electrical path from the opposite side through the via hole. A dummy electrode can increase the insulation effect between electrodes or leads, and can provide rigidity to maintain the shape of the distal part.

Along the width direction of the distal portion of the rear electrode, a first edge trench, a lead extending backward from the front electrode, a first internal trench, a lead or dummy electrode, a second internal trench, a rear electrode, and a second edge trench may be disposed. there is.

The first internal trench may be disposed between a lead or dummy electrode extending from the front electrode to the rear, and the second internal trench may be disposed between the dummy electrode or the rear electrode.

The reference electrode may be placed on the same plane as the working electrode.

When a plurality of working electrodes are provided, the first working electrode and the second working electrode may be disposed on different sides. The biomarker that reacts with the first working electrode may be the main measurement target, including glucose, and the biomarker that reacts with the second working electrode may be to complement the accurate measurement of the first working electrode, such as acetaminophen. . Placing the reference electrode on the same surface as the first working electrode so that the distance from the first working electrode is close can increase the accuracy of the measurement results.

When a plurality of working electrodes are provided, the first working electrode and the second working electrode may be disposed on the same side. The reference electrode may be disposed between the first working electrode and the second working electrode. This may be to ensure accurate measurement results of the analyte by making the distance between the reference electrode and the first working electrode and the distance between the reference electrode and the second working electrode substantially the same.

A via hole 411 may be formed to connect the electrode on the second side to the lead 426 on the first side. The via hole 411 can be freely placed in any one of the distal part 406, the middle part 404, and the proximal part 402.

When the sensor pad 428 of the proximal portion 402 is installed on the first side of the electrochemical sensor 428, the leads 426 connected to the electrodes of the second side are connected to the distal portion 406, the middle portion 404, and the proximal portion. It may be electrically connected to the lead 426 on the first side or the sensor pad 428 on the first side through the via hole 411 formed in any one of (402).

When the via hole 411 is formed in the distal portion 406, the lead 426 may be formed on only one side of the electrochemical sensor 400 from the portion where the via hole 411 is formed to the sensor pad 428, and on the other side. Since the lead 426 is not formed, lead placement can be simplified.

With reference to FIGS. 4 to 8 , an example of electrode arrangement in the distal portion 406 will be described in detail.

Figures 4 and 6 may be an example of a case where two merged electrodes extending in the longitudinal direction of the distal portion 406 are disposed sequentially, and Figure 8 shows an opening 423a or a via hole 411 that can be formed in the frontmost electrode. This may be an example.

FIG. 5 may be a schematic diagram of FIG. 4, and FIG. 7 may be a schematic diagram of FIG. 6.

4 and 5, the distal portion 406 includes a first working electrode 424a, a second working electrode 424b, a first counter electrode 424c, a second counter electrode 424d, and a reference electrode 424e. Five types of electrodes including can be placed.

6 and 7, the distal portion 406 has four types of electrodes including a first working electrode 424a, a second working electrode 424b, counter electrodes 424c and 424d, and a reference electrode 424e. can be placed. 6 is provided with a via hole 411 that electrically connects the first counter electrode 424c and the second counter electrode 424d of FIG. 4, so that the first counter electrode 424c and the second counter electrode 424d are It may be the case that the same type of function is performed. As a result, Figure 4 may be an example of the 5-electrode method, and Figure 6 may be an example of the 4-electrode method.

4 to 7, for uniform reactivity between the analyte in the body and the electrode, the first working electrode 424a and the second working electrode 424b may be disposed on opposite sides, and the first working electrode (424a) 424a) and the second working electrode 424b may have the same area. Due to the nature of the working electrode that reacts with analytes in the body, it may be important to form the first working electrode 424a and the second working electrode 424b to have the same area and to arrange them symmetrically in the distal portion 406.

By arranging the first working electrode 424a and the second working electrode 424b on opposite sides with the largest area, the area utilization of each of the first working electrode 424a and the second working electrode 424b will be maximized. You can.

The frontmost electrode on the first side may be the first working electrode 424a, and the frontmost electrode on the second side may be the second working electrode 424b. The leads 426 may not be formed around the sides of the first and second working electrodes 424a and 424b, and the width and length of the distal portion 406 may be utilized to the maximum.

When the via hole 411 is formed in the base layer 410 facing the first working electrode 424a and the second working electrode 424b, which vertically correspond to each other, the first working electrode 424a or the second working electrode ( A lead 426 may be formed around the electrode located behind 424b).

The via hole 411 may not be formed in the base layer 410 corresponding to the first working electrode 424a and the second working electrode 424b. The first working electrode 424a may have a lead 426 formed around the first counter electrode 424c behind the first working electrode 424a, and a lead 426 extending to the rear of the first working electrode 424a. The working electrode 424b may have a lead 426 formed around the second counter electrode 424d behind the second working electrode 424b and extending to the rear of the second working electrode 424b.

The reference electrode 424e extending backward to the working electrode may be disposed behind the first working electrode 424a or behind the second working electrode 424b. The main biomarker measured by the first working electrode 424a includes glucose, etc., and the biomarker measured by the second working electrode 424b is used for accurate measurement of the first working electrode 424a, such as acetaminophen. In this case, the accuracy of the measurement results can be increased if the reference electrode 424e is disposed on the same surface as the first working electrode 424a so that the distance from the first working electrode 424a is close.

The via hole formed in the lead 426 extending backward from the first working electrode 424a and the via hole formed in the lead 426 extending backward from the first counter electrode 424c are located behind the first counter electrode 424c. It may be formed in the first area located. The first working electrode 424a and the first counter electrode 424c may be connected to opposite sides through a via hole in the first area.

The first area may be located between the first counter electrode 424c and the reference electrode 424e located behind the first counter electrode 424c.

If the reference electrode 424e is disposed continuously after the first counter electrode 424c without a first area, the lead 426 extending backward from the first working electrode 424a and the lead 426 extending backward from the first counter electrode 424c The subsequent lead 426 may be disposed around the reference electrode 424e. In this case, there may be no need for a via hole to turn the first working electrode 424a and the first counter electrode 424c on the first side to the second side. However, in this case, since two leads 426 are formed around the reference electrode 424e, a sufficient area for the reference electrode 424e may not be secured, so that a space between the first counter electrode 424b and the reference electrode 424e may not be secured. By arranging the via hole in the first area, the reference electrode 424e can utilize the entire width of the distal portion 406.

In order to maximize the electrode area on both sides of the distal portion 406 that invades the body, a portion connected to the other side through the via hole 411 may be formed at the rear or middle portion 404 of the distal portion 406. Since the via hole 411 is formed by a fine laser process, the electrode 424 on the other side is connected to one side to be connected to the sensor pad 428 formed on one side to quickly and accurately check whether the via hole 411 has been formed properly. The via hole 411 may be formed at the rear end of the distal portion 406 or near the beginning of the middle portion 404 .

A lead on the second side connected to the first working electrode 424a on the first side through a via hole, a lead on the second side connected through a via hole with the first counter electrode 424c on the first side, and a lead on the second side connected to the first working electrode 424a on the first side through a via hole. The lead of the second side connected to the second working electrode 424b and the lead of the second side connected to the second counter electrode 424d of the second side are located behind the second counter electrode 424d. It can be electrically connected to the first side through the via hole in the second region. In the case of Figure 5, the lead of the second side connected to the first counter electrode 424c of the first side through a via hole, and the lead of the second side connected to the second counter electrode 424d of the second side are It may be the same case.

All of the sensor pads 428 of the proximal portion 402 may be formed to be exposed in the first direction of the first surface. The second region may be formed near the beginning of the middle portion 404 or at the posterior end of the distal portion 406, posterior to the reference electrode 424e.

The via hole in the second region may be formed in the middle portion 404 or the proximal portion 402, but if the via hole in the second region is formed near the rear end of the distal portion 406 or the beginning of the middle portion 404, the via hole in the second region may be formed in the middle portion 404 or the proximal portion 402. No lead 426 is formed on the second side of 404 or the second side of proximal portion 402, so that lead placement can be simplified.

FIG. 8 may be an example in which the merge electrode is disposed as the rear electrode 424b adjacent to the front electrode 424a.

The via hole 411 located behind the rear electrode 424 may be for connecting the frontmost electrode 424a and the rear electrode 424b to opposite sides, and in this case, the sensor pad 428 of the proximal portion 402 Can be arranged so that both are exposed on the opposite side.

Figure 8 (a) may be a case where a dummy electrode is placed as the front electrode, and Figure 8 (b) may be a case where a split electrode is placed as the front electrode and a via hole is formed through which the split electrode is electrically connected to the other surface. 8(c) may be a case where a split electrode is disposed as the frontmost electrode and a via hole through which the split electrode is electrically connected to the other surface is not formed.

The dummy electrode or split electrode may be an electrode 424a that completely fills the width of the distal portion 406, and a lead 426 may be formed around the rear electrode 424b.

Referring to FIG. 8, if the first front electrode 424a on the first side is a dummy electrode, the area occupied by the first front electrode can be minimized, and the first rear electrode 424b along the longitudinal direction of the distal portion 406 ) can be secured widely.

In this case, the second most advanced electrode on the second side may be an electrode that completely fills the width of the distal portion 406. A lead extending backward from the second most front electrode may not be formed around the second rear electrode adjacent to the second most front electrode.

In order for the second front electrode to be electrically connected to the rear, it needs to be connected to the first front electrode 424a through the via hole 411.

The second front electrode on the second side may be electrically connected to the first front electrode 424a through a via hole, and the first front electrode 424a on the first side may be a lead extending backward from the first front electrode 424a. It can be connected to the rear of the first rear electrode 424b through 426, and the lead 426 extending rearward from the first front electrode 424a on the first side is positioned past the first rear electrode 42b. , may be electrically connected to the lead on the second side or the electrode on the second side through the via hole 411.

When the first front electrode 424a on the first side is a split electrode and the first front electrode 424a is electrically connected to the second front electrode on the second side through the via hole 411, the first front electrode 424a on the first side is electrically connected to the second front electrode 424a on the first side. 1 Compared to the case where the front-most electrode 424a is a dummy electrode, the first front-most electrode 424a may require space for forming the opening 423a.

The first foremost electrode 424a on the first side and the second foremost electrode on the second side are connected to any one of the first working electrode, the second working electrode, the first counter electrode, the second counter electrode, and the reference electrode. It may be the same type of electrode.

When the first front electrode 424a on the first side is a split electrode and a via hole connecting the first front electrode 424a on the first side and the second front electrode on the second side is not formed, FIGS. 4 and 4 It may be similar to case 6.

Figure 8(c) may be a split electrode, and Figures 4 and 6 may be a case where the frontmost electrode is a combined electrode. This may vary depending on the type of electrode placed. In the case of (c) of FIG. 8, the frontmost electrode may be a reference electrode, and in the case of FIGS. 4 and 6, the frontmost electrode may be a working electrode or a counter electrode.

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 420... trench
420a...inner trench 420b...edge trench
422... opening 422a... proximal opening
422b... distal opening 423a... first opening
423b... second opening 423c... third opening
423d... fourth opening 424... electrode
424a... first electrode 424b... second electrode
424c... third electrode 424d... fourth electrode
424e... fifth electrode 425... dummy 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... 3rd sensor pad 428d... 4th 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 (12)

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 electrochemical sensor includes a flexible base layer, a conductive layer laminated on the base layer, and an insulating layer attached on the conductive layer,
The electrode closer to the end of the distal part is called the front electrode, and the electrode less close to the end of the distal part than the front electrode is called the back electrode,
The most anterior electrode is the one closest to the distal end of the anterior electrodes,
The electrodes are provided on both sides of the distal portion,
A continuous analyte measuring device wherein at least one of the front electrode disposed on one surface of the distal portion and the rear electrode adjacent to the front electrode has a long rectangular shape extending along the longitudinal direction of the distal portion.
According to claim 1,
A continuous analyte measuring device in which the rear electrode adjacent to the front electrode does not completely fill the distal portion along the width direction of the distal portion.
According to claim 1,
The front electrode is a continuous analyte measuring device formed to completely fill the distal portion along the width direction of the distal portion.
According to claim 1,
The conductive layer is a continuous analyte measuring device including a double-sided conductive layer in which metal is sputtered on both the upper and rear surfaces of the base layer where the via hole is formed and the via hole.
According to claim 1,
A lead is provided to electrically connect the electrode and the sensor pad,
The width of the lead is smaller than the width of the electrode,
The lead is not formed around the foremost electrode along the longitudinal direction of the distal portion,
The lead is formed around the rear electrode adjacent to the front electrode along the longitudinal direction of the distal portion,
The width of the most anterior electrode is equal to the width of the distal portion,
The width of the rear electrode adjacent to the front electrode, plus the width of the lead formed around the rear electrode, is equal to the width of the distal portion.
According to claim 1,
The conductive layer is laminated on the base layer by full sputtering,
An edge trench is provided by removing a portion of the conductive layer corresponding to the outer edge of the electrochemical sensor,
In the front electrode, the remaining portion excluding the edge trench along the width direction of the distal portion is filled with the front electrode,
The width of the edge trench plus the width of the front electrode is equal to the width of the distal portion,
A lead extending backward from the front electrode along the longitudinal direction of the distal portion is formed around the rear electrode adjacent to the front electrode,
An internal trench is provided between the rear electrode and the lead to insulate the rear electrode and the lead,
At the rear electrode, the width of the edge trench, the width of the lead extending posteriorly from the front electrode, the width of the inner trench, and the width of the rear electrode plus the width of the distal portion is equal to the width of the distal portion.
According to claim 1,
The conductive layer is laminated on the base layer by full sputtering,
An edge trench is provided by removing a portion of the conductive layer corresponding to the outer edge of the electrochemical sensor,
A lead extending backward from the front electrode along the longitudinal direction of the distal portion is formed around the rear electrode adjacent to the front electrode,
An internal trench is provided between the rear electrode and a lead extending backward from the front electrode, to insulate the rear electrode and the lead,
The rear electrode and the leads extending backward from the front electrode are spaced apart from each other,
A dummy electrode that does not face the lead or the opening of the insulating layer is disposed between the rear electrode and a lead extending backward from the front electrode,
Along the width direction of the distal portion of the rear electrode, a first edge trench, a lead extending backward from the front electrode, a first internal trench, a lead or dummy electrode, a second internal trench, a rear electrode, and a second edge trench are disposed. A continuous analyte measuring device.
According to claim 1,
An opening is formed in the insulating layer to expose a portion of the electrode to the outside,
At least one of the front electrode and the back electrode adjacent to the front electrode has a long rectangular shape extending along the longitudinal direction of the distal portion,
A continuous analyte measuring device in which a plurality of openings are formed in at least one of the front electrode and the rear electrode adjacent to the front electrode along the longitudinal direction of the distal portion.
According to claim 1,
The electrode is any one of a first working electrode, a second working electrode, a first counter electrode, a second counter electrode, and a reference electrode,
An opening is formed in the insulating layer to expose a portion of the electrode to the outside,
Among the frontmost electrode and the rear electrode adjacent to the frontmost electrode, the electrodes in which the openings are provided in plural numbers along the longitudinal direction of the distal portion include the first working electrode, the second working electrode, the first counter electrode, and the first working electrode. 2 Continuous analyte meter with either counter electrode.
According to claim 1,
A via hole is provided to electrically connect electrodes on both sides of the distal portion,
The via hole is formed to penetrate the base layer,
No via hole is provided in the front electrode,
A continuous analyte measuring device including a lead connected backward from the front-most electrode and a via hole in the facing base layer that electrically connects the front-most electrode to the opposite side.
According to claim 1,
A lead is provided to electrically connect the electrode and the sensor pad,
The width of the lead is smaller than the width of the electrode,
A first front electrode and a first rear electrode adjacent to the first front electrode are disposed on the first side of the distal portion,
A second front electrode and a second rear electrode adjacent to the second front electrode are disposed on the second surface of the distal portion,
The lead is not formed around the first most anterior electrode along the longitudinal direction of the distal part, and a lead is formed around the first rear electrode extending backward from the first most anterior electrode along the longitudinal direction of the distal part. ,
The lead is not formed around the second most anterior electrode along the longitudinal direction of the distal part, and a lead extending backward from the second most anterior electrode is formed around the second rear electrode along the longitudinal direction of the distal part. ,
The first front electrode is electrically connected to the second surface through a via hole facing a lead extending backward from the first front electrode,
The first rear electrode is electrically connected to the second surface through a via hole facing the lead extending backward from the first rear electrode.
According to claim 1,
A lead is provided to electrically connect the electrode and the sensor pad,
The width of the lead is smaller than the width of the electrode,
A first front electrode and a first rear electrode adjacent to the first front electrode are disposed on the first surface of the distal portion,
A second front electrode and a second rear electrode adjacent to the second front electrode are disposed on the second surface of the distal portion,
The lead is not formed around the first most anterior electrode along the longitudinal direction of the distal part, and a lead is formed around the first rear electrode extending backward from the first most anterior electrode along the longitudinal direction of the distal part. ,
A lead extending backward from the second most front electrode is not formed around the second rear electrode,
A continuous analyte measuring device in which a via hole is formed in the base layer facing the first and second front electrodes to electrically connect the first and second front electrodes.

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