KR102854090B1 - Continuous analyte device including electrochemical sensor - Google Patents

Abstract

The continuous analyte measuring device of the present invention may include an electrochemical sensor including a distal portion having a plurality of electrodes formed therein that react with an analyte in the body, a proximal portion having sensor pads formed therein that are connected to the electrodes, and an intermediate portion positioned between the distal portion and the proximal portion, a main substrate having at least one of a power supply portion, a communication portion, and a control portion formed therein, and a housing in which the main substrate is accommodated, and a transmitter attached to the skin.

Description

Continuous analyte device including electrochemical sensor

The present invention relates to a continuous analyte measuring device including an electrochemical sensor having an electrode formed therein that reacts with an analyte in the body.

When the inserter is taken as the 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 end, and the other end of the electrochemical sensor inserted into the body is located far from the inserter and can be called the distal end.

A proximal portion of the electrochemical sensor may be electrically connected to a main substrate of a transmitter, and a distal portion of the electrochemical sensor may be at least partially inserted into a body. The proximal and distal portions may be positioned at opposite ends. The proximal portion of the electrochemical sensor may be electrically connected to a main substrate of the transmitter, which includes an electrical circuit necessary for measuring an analyte including glucose.

The electrochemical sensor may have a flexible base layer to alleviate pain during invasive procedures and reduce foreign body sensation when worn, and the electrochemical sensor may need to be minimized in thickness and size.

As the size of an electrochemical sensor decreases, the area of the electrode formed at the distal end may also decrease. If the electrode area is insufficient, signal interference due to noise can occur. Therefore, when manufacturing electrochemical sensors, it is necessary to consider both the reduction in sensor size and the increase in electrode area.

Electrochemical sensors need to be as small as possible to alleviate pain and reduce foreign body sensation during invasive procedures. As the size of the electrochemical sensor decreases, the electrode area formed at the distal end may also decrease. Insufficient electrode area can lead to signal interference due to noise. Therefore, when manufacturing electrochemical sensors, it is necessary to meet the trade-off between sensor size reduction and securing electrode area.

(Patent 0001) Application No.: 1020070030346

The continuous analyte meter of the present invention may provide an embodiment of a distal portion including an electrode, via hole, or lead having improved reactivity with an analyte within the body while minimizing the width and length of the distal portion that is at least partially invasive within the body.

The continuous analyte measuring device of the present invention comprises an electrochemical sensor including a distal portion having a plurality of electrodes formed thereon that react with an analyte in the body, a proximal portion having sensor pads formed thereon that are connected to the electrodes, and an intermediate portion positioned between the distal portion and the proximal portion;

A main board having at least one of a power supply unit, a communication unit, and a control unit formed thereon, a housing in which the main board is housed, and a transmitter attached to the skin;

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.

A plurality of electrodes are provided on both sides of the above distal portion,

A split electrode is provided that divides each of the above electrodes into multiple parts,

The shape of each of the above split electrodes may be different.

In one embodiment of the present invention, the distal portion may be alternately arranged with split electrodes that do not completely fill the width of the distal portion and split electrodes that completely fill the width of the distal portion.

The split electrode may not extend long along the length of the distal portion and may have an area that can be formed by a single opening.

A non-filled electrode may mean that leads or other electrodes are placed around the electrode in the width direction of the distal portion.

Alternatively, a full-fill electrode may mean that the distal portion, excluding the edge trench, is filled with the electrode. A full-fill split electrode may match the width of the distal portion, excluding the edge trench.

A split electrode that does not fill the entire body may have split leads arranged along the width direction of the distal portion.

The electrode portion may include a full-filling split electrode and a split lead connecting the full-filling split electrode.

The electrode portion may have a comb-shaped shape. The fully filled segmented electrodes may be comb-shaped teeth, and the remaining non-filled segmented electrodes may be located in the spaces between the teeth.

The split electrode of the electrode part on one side of the distal portion, and the split electrode on the other side of the distal portion that is electrically connected to the split electrode of the electrode part on one side of the distal portion through a via hole, may be the same type of electrode as any one of the working electrode, the counter electrode, and the reference electrode.

The split electrode may include a first split electrode and a second split electrode, and the first split electrode and the second split electrode may be different types of electrodes.

When the first split electrode and the second split electrode are arranged alternately, the first electrode unit may include the first split electrode and the first split lead, and the second electrode unit may include the second split electrode and the second split lead. The first split electrode of the first electrode unit and the second split electrode of the second electrode unit may be arranged alternately along the length direction of the distal portion.

When the first electrode portion and the second electrode portion are formed, at least one split electrode that fills the entire width of the distal portion may be provided. This split electrode may be the frontmost electrode, and the split electrodes of the electrode portion may be arranged adjacent to each other as a rear electrode.

The first electrode portion and the second electrode portion may have two comb-shaped shapes facing each other and fitted together, and the teeth of each electrode portion may be positioned in the space between the teeth of the other electrode portion.

The first electrode portion may be provided on the first surface of the distal portion, and the second electrode portion may be provided on the second surface of the distal portion.

A split electrode of the same type as the first split electrode of the first side may be provided on the second side. The first split electrode and the split electrode of the same type as the first split electrode may be arranged at the same symmetrical positions with the base layer in the middle. The first split electrode and the split electrode of the same type as the first split electrode may be electrically connected to each other through a via hole formed to penetrate the base layer.

Similarly, a split electrode of the same type as the second split electrode of the second side may be provided on the first side. The second split electrode and the split electrode of the same type as the second split electrode may be arranged at the same position symmetrically with the base layer in the middle. The second split electrode and the split electrode of the same type as the second split electrode may be electrically connected to each other through a via hole formed to penetrate the base layer.

The split electrode on one side of the distal portion can be electrically connected to the split electrode on the other side of the distal portion through a via hole.

A full-filling split electrode on one side of the distal portion can be connected to a non-full-filling split electrode on the other side of the distal portion through a via hole.

The first split electrode of the first electrode portion of the first side may not be electrically connected to the second split electrode of the second electrode portion of the second side.

In another embodiment of the present invention, the distal portion may have alternating split electrodes that do not completely fill the width of the distal portion.

A first split electrode and a second split electrode may be alternately arranged on one side of the distal portion of the present invention. A split lead may be provided that electrically connects all of the first split electrodes. The split lead may be positioned around the first and second split electrodes.

The split lead can extend along the length of the distal portion, parallel to the first split electrode and the second split electrode.

FIG. 1 is a cross-sectional view of the inserter, transmitter, needle, and electrochemical sensor of the present invention.
Figure 2 is a diagram illustrating a trench of the present invention.
Figure 3 is a flowchart of a method for manufacturing an 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.

Hereinafter, an example embodiment will be described in which 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 body glucose concentration and can be expanded to a continuous analyte measuring device that measures other biomarkers.

<Inserter and Transmitter>

FIG. 1 may illustrate one embodiment of the connection 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 leaving the inserter (100) and being invasive or attached to the body.

Referring to FIG. 1, the electrochemical sensor (400) of the present invention can be attached to the skin together with a transmitter (200). The transmitter (200) can control a signal measured by the electrochemical sensor (400) and continuously transmit the measured blood sugar level 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 including glucose, lactate, etc.

The electrochemical sensor (400) and transmitter (200) may be provided to the user in a state loaded in the inserter (100) prior to skin attachment. By the user's attachment action, the electrochemical sensor (400) and transmitter (200) may be detached 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 end (402), 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 end (406), the part that interconnects the proximal end (402) and the distal end (406) and is positioned between the proximal end (402) and the distal end (406) may be referred to as the middle end (404), and the part of the middle end (404) that is flexibly bent and where the direction of the electrochemical sensor (400) is greatly changed may be referred to as the folding end (405).

Invasiveness 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 in which they are already bonded to each other before being attached to the skin.

The transmitter (200) is positioned at a first position while loaded into the inserter (100), and the transmitter (200) moves from the first position to a second position by a user action, and the transmitter (200) can be attached to the skin at the second position. The insertion direction of the transmitter (200) and the electrochemical sensor (400) may be from the first position toward the second position.

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

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

The driving unit (102) can advance the needle (300) or the transmitter (200) from a first position to a second position so that the needle (300) or the distal portion (406) is inserted into the skin.

The driving unit (102) can separate the needle (300) from the transmitter (200) and the electrochemical sensor (400) by attaching the transmitter (200) and the electrochemical sensor (400) to the skin at a second position and then retracting the needle (300) from the second position to a third position.

The driving unit (102) can be connected to a needle handle (310) to which a needle (300) is fixed. The needle handle (310) can be attached to and 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 can face the main substrate (202), and the other side of the electrochemical sensor (400) can be exposed to the internal space of the transmitter (200).

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

Since the electrochemical sensor (400) at least partially penetrates the skin, the electrochemical sensor (400) or the base layer (410) may be flexible to alleviate pain during penetration and reduce foreign body sensation when worn.

The distal portion (406) of the electrochemical sensor (400) may be positioned on an exposed portion along the length of the needle (300). The end of the needle (300) is positioned at a position that protrudes further than the end of the distal portion (406). After the skin is incised by the needle (300), the distal portion (406) of the electrochemical sensor (400) may be inserted into the body.

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 is invasive into the body.

When voltage is applied to the electrode (424) of the present invention, an analyte in the body, including glucose, can be oxidized and reduced, and the electrons generated during this process can cause current to flow. The generated current can be determined based on the concentration of the analyte in the body, thereby quantifying the signal of a biomarker, including blood sugar levels.

An electrode (424) that can be inserted into the body and undergo 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 an electrode (424) may be formed in the proximal portion (402). A current generated through an electrochemical reaction with body glucose in the distal portion (406) may be connected to the sensor pad (428) of the proximal portion (402) along a lead (426) formed on the base layer (410). The sensor pad (428) may be electrically connected to the main substrate (202) through a contact pad.

The middle portion (404) may be provided with a plurality of leads (426) connecting the electrodes (424) and the sensor pads (428). The plurality of leads (426) may be formed by a laser etching method that removes a portion of the base layer (410) by irradiating the base layer (410) with a laser. Accordingly, each lead (426) may be arranged so as not to intersect and twist with each other.

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 a porous platinum colloid.

The reference electrode can be an electrode with a constant potential that can serve as a reference. The reference electrode can be one of a silver chloride (Ag/AgCl) electrode, a calomel electrode, or a mercuric (I) sulfate electrode. If the biomarker is glucose, a silver chloride (Ag/AgCl) electrode can be used as the reference electrode for invasive applications.

In the case of an invasive electrochemical sensor (100), the size needs to be minimized as much as possible for reasons such as pain relief during invasiveness and reduction of foreign body sensation when worn. As the size of the electrochemical sensor (400) decreases, the area of the electrode (424) may also decrease. If the area of the electrode (424) is not sufficiently secured, signal disturbance due to noise may occur, so it is necessary to consider both aspects of reducing the size of the sensor (100) and securing the area of the electrode (424) when manufacturing the electrochemical sensor (400).

The length of the invasive electrochemical sensor (400) inserted into the skin may be in the range of 3 to 12 mm. If the insertion length is less than 3 mm, the stability and signal stability of the sensor itself 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, the sensor may be located in a range where pain points in the human body are distributed, which may cause severe pain and damage tissues in the living body such as blood vessels or nerves. In addition, the width of the invasive portion of the distal portion (406) may be in the range of 100 to 600 μm. The thickness of the invasive portion of the distal portion (406) may be in the range of 10 to 300 μm, and preferably in the range of 50 to 150 μm.

Since at least a part 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 it is necessary to reduce it to a predetermined width (e.g., 600 μm) or less. If three or more electrodes (424) are all arranged on only one side of the distal part (406) that is invasive into the body, the width of the distal part (406) must be widened to secure space for the three or more electrodes and the leads (426) connected thereto in terms of measurement data, but it may be limited to a predetermined width (e.g., 600 μm) or less in terms of pain relief. Both trade-off relationships must be satisfied.

When the transmitter (200) is attached to the skin and the electrochemical sensor (400) is invasive into the body, the folded portion (405) can remain in a bent state for a considerable period of time. To reduce the torsional load of the folded portion (405), the width of the middle portion (404) or the folded portion (405) can 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 fold portion (405) may increase in proportion to the number of electrodes arranged in the distal portion (406). As a plurality of leads (426) are arranged in the fold portion (405), the insulation may decrease 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 fold portion (405).

In order to minimize the size of the distal portion (406) that invades the body while securing sufficient space for placement of the electrode (424), the electrode (424) can be placed on both sides of the distal portion (406).

To increase the accuracy when detecting an electrochemical signal from the electrode (424) of the distal portion (406), the number of working electrodes (WE) placed in the distal portion (406) can be increased.

The working electrodes, including the first working electrode and the second working electrode, may be provided in multiple numbers on the same side of the distal portion (406), or at least one may be provided on both sides of the distal portion (406).

Biomarkers that react with the electrode (424) may include glucose, lactose, or ketone.

The first working electrode and the second working electrode may be composed of the same type of biomarker to increase the reactivity and thus increase the detection accuracy of the electrochemical signal, or may be composed of different types of biomarkers to simultaneously measure multiple electrochemical signals.

Additionally, the first working electrode and the second working electrode may complement each other in measuring a single biomarker. For example, if the first working electrode measures blood glucose concentration, the second working electrode may measure acetaminophen concentration. When taking acetaminophen, the blood glucose level measured in the body may be higher than the actual level, and the blood glucose concentration measured by the first working electrode needs to be judged based on the acetaminophen concentration measured by 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).

A trench (420) can be formed by laser etching the conductive layer (412). The width (W1, W2) of the trench (420) formed by laser etching can be 2 to 200 μm. The width (W1, W2) of the trench can be increased by moving the laser head (490) that irradiates the laser multiple times and performing laser etching multiple times.

The electrode (424) and the sensor pad (428) may be formed by a laser etching method that irradiates a laser to the conductive layer (412) to remove a portion of the conductive layer. After the conductive layer (412) is laminated, the edge boundary of the electrode (424) and the edge boundary of the sensor pad (428) may be formed. The lead (426) connecting the electrode (424) and the sensor pad (428) may be formed by vertically cutting a portion of the conductive layer (412), similar to the electrode (424) and the sensor pad (428). After the edge boundary of the electrode (424) and the edge boundary of the sensor pad (428) are formed, the insulating layer (416) may be attached.

A trench (420) may be engraved into the conductive layer (412), thereby allowing a conductive island (430) to be patterned into the conductive layer (412). The height of the trench (420) may be the same as the thickness of the conductive layer (412). The thicknesses of the conductive layer (412), the electrode (424), and the 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 width of 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 by laser etching, no matter how complex the pattern of the electrode (424) is or how narrow the width of the trench (420). To simplify the process, it may be preferable that the conductive layer (412) is formed by sputtering a metal including gold or copper over the entire exposed area of the base layer (410).

A via hole (411) penetrating the base layer (410) can be provided.

By means of the via hole (411), the double-sided conductive layers (412) laminated on the base layer (410) can be electrically connected to each other.

The via hole (411) can be formed by a laser etching method that removes a portion of the base layer (410) by irradiating the base layer (410) with a laser.

When forming a double-sided electrode (424), both the upper and lower surfaces of the base layer (410) in which the via hole (411) is formed can be sputtered with metal. The formation of this double-sided conductive layer (412) can be performed on the upper and lower surfaces at different times, or on both surfaces simultaneously.

Electrodes (424) or leads (426) can be electrically separated from each other by trenches (420). The narrower the trenches (420), the more the electrode (424) area can be secured for analyte reaction. Conversely, the narrower the trenches (420), the worse the insulation may be. By forming the trenches using laser etching, the trade-off between miniaturization and insulation can be satisfied. The narrower the width of the folded portion (405), the less torsional force can be reduced, and fatigue failure can be prevented even when the folded portion (405) is bent and fixed for a considerable period of time.

By means of the trench (420), it is easy to secure sufficient area for the lead (426), electrode (424), or sensor pad (428), thereby improving the signal transmission rate and reducing the short-circuit failure rate.

The base layer (410) may include at least one of a synthetic resin, polyimide (PI), and polyethylene terephthalate (PET) as an insulating material, and preferably, polyimide (PI) may be used as the material of the base layer (410) for a thin and flexible electrochemical sensor (400). The thickness of the base layer or the insulating layer may be 100 micrometers or less.

A conductive layer (412) may be formed on the base layer (410) by sputtering or the like. The thickness of the conductive layer (412) formed by depositing metal by blowing it at the atomic or molecular level 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) can be formed by a laser etching method that removes a portion of the conductive layer (412) by irradiating the conductive layer (412) with a laser, thereby satisfying the trade-off between miniaturization and insulation.

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

After the conductive layer (412) is formed, an insulating layer (416) can be attached. The insulating layer (416) can be adhered on the conductive layer (412) 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.

A portion of the insulating layer (416) may be removed by a cutter or puncher. If the opening (422) of the insulating layer (416) is small and requires micro-machining, the laser etching method used to form the trench (420) of the conductive layer (412) may be used to process the opening (422) of the insulating layer (412).

The same may be true for the base layer (410). Since the via hole (411) required for double-sided formation requires micro-machining, 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 a via hole (411) is formed by cutting a portion of the base layer (412), the conductive layer (412) can be double-sided sputtered with the same metal material that is seamlessly continuous along the upper surface of the base layer (410), the surface of the via hole (411), and the back surface of the base layer (410).

An opening (422) may be formed through the insulating layer (416). The electrode (424) and the sensor pad (428) formed in 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 a contact pad of the main substrate (202).

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 come into contact with interstitial fluid or blood flow to cause an electrochemical reaction with the analyte.

The electrochemical sensor (400) may include a porous selective permeable layer (418) surrounding the surface of the electrode (424). The selective permeable layer (418) may be applied to the electrode (424) of the distal portion (406) to react with an analyte that reacts in the body.

The selective permeable layer (418) may have mesoporous characteristics. The size of the mesopores may be 2 to 50 nm.

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

The selective transmission layer (418) can be applied to the electrode (424) through the distal opening (422b) in a state where the base layer (410), the conductive layer (412), and the insulating layer (416) are laminated. When a plurality of distal openings (422b) face different types of electrodes, the first selective transmission layer (418a) to the fourth selective transmission layer (418d) can each include different types of materials.

Each opening (422) formed corresponding to each electrode (424) may have a different type of selective transmission layer (418) applied thereto. A first opening (423a) may face a first electrode (424a), and a first selective transmission layer (418a) may be applied to the first opening (423a). The same may be applied to the second electrode (424b) to the fifth electrode (424e), the second opening (423b) to the fifth opening (423e), and the second selective transmission layer (418b) to the fifth selective transmission layer (418e).

A bonding layer (414) may be provided to attach the insulating layer (416) to the conductive layer (412). The bonding layer (414) may be positioned between the conductive layer (412) and the insulating layer (416). When an opening (422) is formed in the insulating layer (416), an opening (422) may also be formed in the bonding layer (414).

At least one of dip coating, spray coating, and paste method may be performed to repeatedly form the selective transmission layer (418).

The electrochemical sensor (400) can form a sensor array by interconnecting base layers (410). The electrochemical sensor (400) can be formed by 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. The formation of an insulating layer (416) and a selectively transparent layer (418) can also be performed simultaneously.

A plurality of electrochemical sensors (400) can be manufactured simultaneously in the form of an array connected to each other and then separated individually.

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

After a conductive layer (412) is deposited on the base layer (410) by a method such as sputtering, a trench (420) can be formed by a method such as laser etching.

A plurality of conductive islands (430) that are separated from each other can be provided in the conductive layer (412) by laser etching or the like. Each conductive island (430) forms a closed surface and can be electrically insulated from each other.

The base layer (410) is exposed at the bottom of the trench (420), and the conductive islands (430) in contact can be insulated by the trench (420).

The conductive island (430) of the proximal portion (402) can form a sensor pad (428), the conductive island (430) of the middle portion (404) or the folded portion (405) can form a lead (426), and the conductive island (430) of the distal portion (406) can form an electrode (424).

The conductive island (430) can be divided into a conductive island (430) in which a portion corresponding to the electrode (424) and the sensor pad (428) is exposed to the outside through a cut portion of the insulating layer (416), and a dummy portion in which the entire portion is covered with the insulating layer (416) so that no portion is exposed to the outside.

When forming conductive islands (430) that are separated from each other by forming a closed surface, dummy parts may be formed between the conductive islands (430). The dummy parts may be used as conductive islands (430) having electrodes (424) or sensor pads (428) when the insulating layer is exposed. The dummy parts may be completely removed by repetitive laser etching, etc. However, since only electrical insulation by the trench is required, there is no need to remove the dummy parts. This is another advantage of the present invention.

When a dummy portion that is too wide is formed at the bottom after forming a trench (420) pattern on the conductive layer (412) and covering it with an insulating layer (416), the dummy portion may be maintained as is without being removed to prevent a part of the insulating layer (416) from sinking downward.

A trench (420) may be formed in the conductive layer (412) by laser etching, which removes a portion of the conductive layer (412) by a laser irradiating 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) may include a conductive island (430) on which the electrode (424) and the sensor pad (428) are formed, or a dummy portion that is entirely covered with an insulating layer (416) so that no portion is exposed to the outside.

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).

The double-sided electrodes (424) formed on both sides of the distal portion (406) can be electrically connected to the sensor pads (428) on both sides of the proximal portion (402) along the double-sided leads (426) formed on both sides of the middle portion (404). In this case, a 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.

Meanwhile, if the sensor pad (428) is formed on both sides of the proximal portion (402), it may be difficult to electrically connect it with the contact pad of the main board (202) using a simple alignment method. For example, a cross-intersection structure or a separate connector portion for inserting or sandwiching the proximal portion (402) may be required to conduct current between the sensor pad (428) and the contact pad. Accordingly, the sensor pad (428) may be formed on only 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), minimizing the size of the distal part (406) can reduce the pain and foreign body sensation felt by the user. Since the continuous analyte measuring device of the present invention is not intended for intermittent and temporary measurement, but for continuous measurement for a predetermined period of time while being invasive or attached to the body, minimizing the size of the distal part (406) is important.

The leads (426) connected to the plurality of electrodes (424) can also be distributed and arranged on both sides of the middle part (424), thereby providing the effect of reducing the width of the middle part (424) compared to the number of electrodes (424) formed.

The effect of reducing the size of the distal portion (406) and reducing the width of the middle portion (424) can also be applied when a via hole (411) is formed in the distal portion (406).

In the present invention, when measuring an analyte, the transmitter (200) can be attached to the skin, the proximal portion (402) can be connected to the contact pad of the transmitter (200), and at least a portion of the distal portion (406) can be invasive into the body. When measuring an analyte in an invasive state, the electrochemical sensor (400) needs to be maintained in a flexibly bent state at the folded portion (405) of the middle portion (424). Therefore, forming the middle portion (424) narrowly can be advantageous for the measurement stability of the electrochemical sensor (400).

If the sensor pad (428) is positioned so that it is exposed only on one side of the proximal portion (402), the width or width may be longer. However, since the sensor pad (428) of the proximal portion (402) is electrically connected to the contact pad of the transmitter (200), there may be no problem even if the width or width is longer than that of the distal portion (406) that is invasive into the body.

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

The via hole (411) of the distal portion (406) can reduce measurement instability depending on the direction in which the electrochemical sensor (400) is inserted into the body, or the arrangement relationship between the distal portion (406) and the needle (300) that guides the insertion of the electrochemical sensor (400) into the body, when electrodes having the same function are placed on both sides of the distal portion (406).

When a via hole (411) is formed in the distal portion (406), a lead (426) and a sensor pad (428) can be formed only on the first surface of the base layer (410), and the second surface of the intermediate portion (424) or the proximal portion (424), excluding the electrode (424) of the distal portion (406), can be surrounded by an insulating layer (416) to block contact with the outside. Since complex leads (426) do not need to be provided on both surfaces of the thin electrochemical sensor (400), the stability of the electric flow of the entire electrochemical sensor (400), including short circuits between leads, can be improved.

When a via hole (411) is formed in the distal portion (406), the first via hole (411a) can be prevented from being contaminated by blocking contact with the outside on both one side and the other side by the insulating layer (416). One end and the other end of the second via hole (411b) can be exposed to the outside through the distal opening (422b).

By means of 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 arranged and connected as the same electrode type, thereby increasing the electrochemical reactivity between the electrode (424) and the reactant regardless of the directionality of the invaded distal portion (406).

Referring to FIG. 2, the trench (420) of the present invention will be described.

After a conductive layer (412) is deposited on the base layer (410) by a method such as sputtering, a trench (420) can be formed by a method such as laser etching.

A plurality of conductive islands (430) that are separated from each other can be provided in the conductive layer (412) by laser etching or the like. Each conductive island (430) forms a closed surface and can be electrically insulated from each other.

The base layer (410) is exposed at the bottom of the trench (420), and the conductive islands (430) in contact can be insulated by the trench (420).

The conductive island (430) of the proximal portion (402) can form a sensor pad (428), the conductive island (430) of the middle portion (404) or the folded portion (405) can form a lead (426), and the conductive island (430) of the distal portion (406) can form an electrode (424).

The conductive island (430) can be divided into a conductive island (430) in which a portion corresponding to the electrode (424) and the sensor pad (428) is exposed to the outside through a cut portion of the insulating layer (416), and a dummy portion (432) in which the entire portion is covered with the insulating layer (416) so that no portion is exposed to the outside.

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) of the proximal portion (402), a first lead (426a) of the folded portion (405), and a first electrode (424a) of the distal portion (406).

The second conductive island (430b) may include a second sensor pad (428b) of the proximal portion (402), a second lead (426b) of the folded portion (405), and a second electrode (424b) of the distal portion (406). The third conductive island (430c) may include a third sensor pad (428c) of the proximal portion (402), a third lead (426c) of the folded portion (405), and a third electrode (424c) of 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 surface, dummy parts (432) may be formed between the conductive islands (430). The dummy parts (432) may be used as conductive islands (430) having electrodes (424) or sensor pads (428) when the insulating layer is exposed. The dummy parts (432) may be completely removed by repetitive laser etching, etc. However, since only electrical insulation by the trench needs to be achieved, there is no need to remove the dummy parts (432). This is another advantage of the present invention.

When a dummy portion (432) that is too wide is formed on the lower portion covered with an insulating layer (416) after forming a trench (420) pattern on the conductive layer (412), the dummy portion (432) may be maintained as is without being removed to prevent a part of the insulating layer (416) from sinking downward.

The trench (420) may include an inner trench (420a) or an edge trench (420b). The inner trench (420a) may insulate between conductive islands (430). The inner trench (420a) may be positioned between at least one of the electrodes (424), the leads (426), and the sensor pads (428).

Meanwhile, since the insulating property is reduced when the conductive layer (412) is exposed to the edge of the electrochemical sensor (400), it is necessary to prevent the side exposure of the conductive layer (412). After the conductive layer (412) is laminated, a portion of the conductive layer (412) can be cut along the edge of the electrochemical sensor (400). This is the edge trench (420b). Accordingly, an insulating layer (416) can be attached to the edge of the electrochemical sensor (400) on the base layer (410) and can be insulated. An insulating layer (416) can be attached to the inner part of the edge of the electrochemical sensor (400) on the conductive layer (412) laminated on the base layer (410).

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

Area A of FIGS. 2 and 3 may represent a portion of an edge trench (420b).

The edge trench (420b) can form the outermost edge of the conductive layer (412).

The edge trench (420b) can prevent the conductive layer (412) from protruding to the side of the electrochemical sensor (400). The edge trench (420b) can 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 electrochemical sensors (400) are processed as an array, the edge trench (420b) can prevent shorts between adjacent sensors (400) or between adjacent conductive islands (430) to prevent shorts from occurring between them.

The edge trench (420b) can be created by laminating a conductive layer (412) on the base layer (410) by full-face sputtering, etc., and then removing the conductive layer (412) at the outer edge of the electrochemical sensor (400) by a laser, etc. The conductive layer (410) on the upper side of the base layer (410) is completely cut off, so that the lower surface of the edge trench (420b) can expose the base layer (410). Therefore, an insulating layer (416) or a bonding layer (414) can be directly bonded to the edge trench (420b) without the conductive layer (412).

By means of the edge trench (420b), a step of the conductive layer (412) can be provided at the edge of the electrochemical sensor (400).

Referring to FIG. 3, a method for manufacturing an electrochemical sensor (400) of the present invention is described in its entirety.

The method for manufacturing an electrochemical sensor may include a conductive layer step of laminating a conductive layer (412) on a flexible base layer (410) of an electrochemical sensor (400), and an insulating layer step of attaching an insulating layer (416) to the conductive layer (412).

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

The via hole (411) can be formed by a laser or mechanical method. The via hole (411) can be formed by a laser etching method in which a portion of the base layer (410) is removed by irradiating the base layer (410) with a laser using a laser head (490).

The via hole step may be performed before the conductive layer step. The conductive layer formation 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) can be blocked from the outside by an insulating layer (416), and the second via hole (411b) can have at least one of its two sides exposed to the outside.

The conductive layer step may include a first conductive layer step of forming a conductive layer (412) on one surface of the base layer (410), and a second conductive layer step of forming a conductive layer (412) on the other surface of the base layer (410).

By the first conductive layer step and the second conductive layer step, the conductive layer (412) can be laminated with the same metal material without any joints along the upper surface of the base layer (410), the surface of the via hole (411), and the back surface of the base layer (410).

This aspect of the present invention may be different from other technologies that stack multiple layers corresponding to the number of electrodes (424) or sensor pads (428) to form electrodes (424) or sensor pads (428) on a base layer (410). When stacking multiple layers corresponding to the number of poles (424) or sensor pads (428) on an electrochemical sensor (400) in which a via hole (411) is formed, a seam such as overlapping of multiple layers may be created around the via hole (411). When conductive layers are stacked so that a seam such as an overlap exists, the thickness of the conductive layer around the via hole (411) may not be uniform, which may be a factor in increasing the defect rate such as a short circuit.

Accordingly, the conductive layer of the present invention can be formed as one layer or a layer that is different from one another on the inner surface of the via hole (411), the upper surface of the base layer (410), and the lower surface of the base layer (410), and can minimize short-circuit defects such as overlap at both ends of the via hole (411), and can also reduce the conductivity defect rate of the via hole (411) itself.

In the insulating layer step, the first via hole (411a) can face the insulating layer (416), and the second via hole (411b) can face the opening (422) of the insulating layer (416).

The insulating layer (412) may be adhered onto the conductive layer (412) in a state where an opening (422) penetrating the insulating layer (412) is formed in the insulating layer step. The electrode (424) may be exposed to the outside through the opening (422) and react with an analyte in the body. The electrode (424) may be formed on both sides of the distal portion (406).

The method for manufacturing an electrochemical sensor may include a trench step in which a trench (420) is formed in a conductive layer (412).

The trench (420) can be formed by laser etching, which removes a portion of the conductive layer (412) with a laser irradiated onto the conductive layer (412).

A heat treatment step may be performed after the conductive layer step or the insulating layer step, as required.

The method for manufacturing an electrochemical sensor may include a selective transmission layer step of applying a selective transmission layer (418) to an opening (422) of an insulating layer (416) by dispensing or the like.

The material of the selective permeable layer (418) may be determined depending on the type of body analyte to be electrochemically reacted with the electrode (424). For example, in the selective permeable layer step, a selective permeable layer containing platinum may be applied to the working electrode, and a selective permeable layer containing silver chloride may be applied to the reference electrode.

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

Electrode placement

Referring to FIGS. 4 and 5, an embodiment of the arrangement of the electrode (424) 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 portion (406) and the sensor pad (428) of the proximal portion (402).

An example embodiment is described in which the sensor pad (428) is formed to be exposed only on one side of the proximal portion (402).

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 portion (406) is invaded into the body may be consistent with the longitudinal direction of the distal portion (406), and the width direction of the distal portion (406) or the width direction of the lead (426) may be perpendicular to the direction of invasion.

The lead (426) may be provided in at least one of the proximal portion (402), the middle portion (404), and the distal portion (406).

The intermediate portion (404) is located midway between the proximal portion (402) and the distal portion (406), and electrically connects the sensor pad (428) of the proximal portion (402) and the electrode (424) of the distal portion (406). Therefore, the electrode (424) and the sensor pad (428) are not disposed in the intermediate portion (404), and only the lead (426) may be disposed. This is because the intermediate portion (404) needs to maintain a flexibly bent state when the electrochemical sensor (400) is invasive into the body for analyte measurement, and this may be to reduce the width of the intermediate portion (404) or the folded portion (405). The narrower the width of the intermediate portion (404) or the folded portion (405), the less torsional force can be reduced, and fatigue failure can be prevented even when the intermediate portion (404) or the folded portion (405) is bent and fixed for a considerable period of time.

A position closer to the end of the electrochemical sensor (400) may be referred to as the front, and a position closer to the end of the electrochemical sensor (400) than the front may be referred to as the rear. Alternatively, when an electric path is formed connecting the sensor pad (428) of the proximal portion (402) and the electrode (424) of the distal portion (406), a position closer to both ends of the electric path may be referred to as the front, and a position closer to both ends of the electric path than the front may be referred to as the rear.

The lead (426) may be positioned around the posterior electrode so that the anterior electrode of the distal portion (406) is electrically connected to the middle portion (404) or the proximal portion (402), or may be positioned alone rather than around the electrode.

A lead (426) positioned on one side of the posterior electrode may extend parallel to the length of the distal portion (406) together with the posterior electrode. In a case where the lead (426) is positioned alone, the lead (426) may be connected to an electrode (424) positioned at the rearmost end of the distal portion (406).

An electrode closer to the end of the distal portion (406) may be referred to as an anterior electrode, and an electrode closer to the end of the distal portion than the anterior electrode may be referred to as a posterior electrode. The anteriormost electrode may refer to the one of the anterior electrodes closest to the end of the distal portion.

The terms anterior electrode, posterior electrode, and anteriormost electrode described below refer to the position of the electrode (424) placed at the distal end (406), and may not necessarily mean that two or more electrodes, the anterior electrode and the posterior electrode, are placed on both sides.

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

The electrode (424) may not have a width that changes along the length of the distal portion (406).

The frontmost electrode and the posterior electrode adjacent to the frontmost electrode may be formed to fill the distal portion (406) in an elongated rectangular shape extending along the length of the distal portion (406).

A full-filled electrode may mean that there are no other electrodes (424) or leads (426) surrounding the electrode (424) along the length of the distal portion (406). The width of the full-filled electrode (424) may be substantially the same as the width of the distal portion (406).

A lead (426) may not be placed around the frontmost electrode, and a lead (426) may be placed around the rear electrode that is placed adjacent to and in series with the frontmost electrode.

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

Additionally, the meaning of a full-filling electrode may mean that electrodes (424) are formed along the width direction of the distal portion (406) except for the edge trench (420b). The width of the full-filling electrode (424) plus the edge trench (420b) may match the width of the distal portion (406).

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). The first edge trench, the electrode (424), and the second edge trench may be arranged in this order along the width direction of the distal portion (406). The sum of the width of the first edge trench, the width of the electrode (424), and the width of the second edge trench may be equal to the width of the distal portion (406).

The arrangement of the first edge trench, the electrode (424), and the second edge trench in the order along the width direction of the distal portion (406) may be located at at least two different electrodes (424) along the length direction of the distal portion (406).

If the edge trenches (420b) formed along the outer edge of the electrochemical sensor (400) are formed with the same width, the first edge trench and the second edge trench may be the same.

The electrode (424) can react with the body analyte through the opening (422). Since one electrode (424) is electrically connected, the same selective permeable layer (418) can be applied to multiple openings (422) formed in one electrode (424).

The longitudinal direction of the distal portion (406) and the longitudinal direction of the electrode may be the same as the invasion direction of the distal portion (406), and the width direction of the distal portion (406) and the width direction of the electrode may be perpendicular to the invasion direction.

An electrode that does not extend along the length of the distal portion (406) may be referred to as a split electrode. The split electrode may be of a size such that one opening (422) is formed along the length of the distal portion.

The reference electrode may be placed on the split electrode, and it may be sufficient for the reference electrode to have one opening (422) placed therein.

The length of the split electrode may be equal to the width of the distal portion (406). The split electrode may be square in shape with similar width and length.

The distal portion (406) may be elongated in the insertion direction and may need to be thin, as at least a portion of the distal portion (406) is inserted into the body. Accordingly, the distal portion (406) may have a flat rectangular shape, and the cross-section of the electrode (424) formed in the distal portion (406) may have a rectangular shape.

The split electrode can be either a working electrode or a counter electrode. The electrode that primarily reacts with the analyte in the body can be the working electrode, and to maximize the reactivity with the analyte, it is necessary to secure the maximum surface area of the working electrode.

On the first side of the distal portion (406), a first anterior electrode, which is the anteriormost electrode of the first side, and a first posterior electrode adjacent to the first anteriormost electrode may be provided, and on the second side of the distal portion (406), a second anterior electrode, which is the anteriormost electrode of the second side, and a second posterior electrode, which is arranged continuously to the second anteriormost electrode, may be provided.

Around the first front electrode of the first side, around the first rear electrode, and around the second front electrode of the second side, a lead (426) may not be formed along the length direction of the distal portion (406).

The width of the first front electrode plus the width of the edge trench (420b), the width of the first rear electrode plus the width of the edge trench (420b), and the width of the second front electrode plus the width of the edge trench (420b) may match the width of the distal portion (406).

The width of the second rear electrode, the width of the edge trench (420b), and the width of the lead (426) formed on the second rear electrode may be equal to the width of the distal portion (406).

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 inner trench (420a) may function to insulate the objects formed in the electrochemical sensor (400) from each other. The objects insulated from each other by the inner trench (420a) may include a lead (426) and an electrode (424).

The inner trench (420a) may include a first inner trench that insulates the lead and the electrode, and a second inner trench that insulates the electrode and the electrode.

If the internal trenches (420a) for insulating the electrodes (424) and leads (426) formed in the electrochemical sensor (400) from each other are formed with the same width, the first internal trench (420a) and the second internal trench (420a) may be the same.

The sum of 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) may match the width of the distal portion (406).

If the position closer to the proximal portion (402) is referred to as the posterior, a peripheral lead (427) extending from the peripheral electrode (425) and extending posteriorly to the distal portion (406) may be provided. The electrode on the second side of the distal portion (406) may be electrically connected posteriorly along the peripheral lead (427) on the first side.

Fig. 4 (a) is a plan view of an embodiment of the distal portion of the present invention, and Fig. 4 (b) may be a rear view.

FIG. 5 may be a schematic diagram of electrical wiring throughout the electrochemical sensor (400) of the embodiment of FIG. 4.

Referring to FIGS. 4 and 5, in the first embodiment of the present invention, a plurality of split electrodes may be alternately arranged in the distal portion (406). One of the plurality of split electrodes may completely fill the width of the distal portion (406), and the remaining split electrodes may not completely fill the width of the distal portion (406).

On the first side of the distal portion (406), a first split electrode (425a) and a third split electrode (425c) may be provided. On the second side of the distal portion (406), a second split electrode (425b) and a fourth split electrode (425d) may be provided. That is, among the split electrodes arranged on the first side, a split electrode excluding the first split electrode may be referred to as a third split electrode, and among the split electrodes arranged on the second side, a split electrode excluding the second split electrode may be referred to as a fourth split electrode.

The first split electrode (425a) and the third split electrode (425c) of the first side can be arranged alternately, and the second split electrode (425b) and the fourth split electrode (425d) of the second side can be arranged alternately.

On the first side, a first split lead (427a) for electrically connecting a plurality of first split electrodes (425a) may be provided. On the second side, a second split lead (427b) for electrically connecting a plurality of second split electrodes (425b) may be provided.

A first split lead (427a) may not be formed along the width direction of the distal portion (406) around the first split electrode (425a), and a first split lead (427a) may not be formed along the width direction of the distal portion (406) around the third split electrode (425c).

A second split lead (427b) may not be formed along the width direction of the distal portion (406) around the second split electrode (425b), and a second split lead (427a) may not be formed along the width direction of the distal portion (406) around the fourth split electrode (425c).

Between the first split lead (427a) and the first split electrode (425a), an internal trench (420a) may be provided to insulate the first split lead (427a) and the first split electrode (425a) from each other.

The above discussion of the internal trench (420a) can also be applied to the internal trench (420a) formed between the second split lead (427b) and the second split electrode (425b).

An edge trench (420b) and the first split electrode (427a) can be arranged along the width direction of the distal portion (406) where the first split electrode (427a) is located.

An edge trench (420b), a first split lead (427a), an internal trench (420a), and a first split electrode (425a) can be arranged along the width direction of the distal portion (406) where the second split electrode (427b) is located.

In the first split electrode (425a) of the first side, the width of the first split electrode (425a) may be the same as the width of the distal portion (406). In the second split electrode (42b) of the second side, the width of the second split electrode (425b) may be the same as the width of the distal portion (406).

In the third split electrode (425c) of the first side, the width of the third split electrode (425c) and the sum of the first split lead (427a) may be equal to the width of the distal portion (406). In the fourth split electrode (425d) of the second side, the width of the fourth split electrode (425d) and the sum of the second split lead (427d) may be equal to the width of the distal portion (406).

Let us examine a case where a trench (420) including an inner trench (420a) and an outer trench (420b) is formed in an electrochemical sensor (400).

The internal trench (420a) can be formed between the split lead (427) and the split electrode (425), and can insulate the split lead (427a) and the split electrode (425) from each other.

The edge trench (420b) may be formed by removing a portion of the conductive layer (412) corresponding to the outer edge of the electrochemical sensor (400). Along the width direction of the distal portion (406), 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). If the edge trenches (420b) formed along the outer edge of the electrochemical sensor (400) are formed with the same width, the first edge trench and the second edge trench may have the same width.

Along the width direction of the distal portion (406) where the first split electrode (425a) of the first side is located, the sum of the width of the first edge trench, the width of the first split electrode (427a), and the width of the second edge trench may be equal to the width of the distal portion. The same may be applied to the second split electrode (425b) of the second side.

Along the width direction of the distal portion (406) where the third split electrode of the first side is located, the sum of the width of the first edge trench (420b), the width of the first split lead (427a), the width of the inner trench (420a), the width of the first split electrode (425a), and the width of the second edge trench (420b) may be equal to the width of the distal portion (406). The same may be applied to the fourth split electrode (425d) of the second side.

The first split electrode (425a) on the first side and the fourth split electrode (425d) on the second side can be electrically connected through a via hole (411). The second split electrode (425a) on the second side and the third split electrode (425d) on the first side can be electrically connected through a via hole (411).

The first split electrode (425a) and the fourth split electrode (425d) may be formed to be symmetrical with respect to the base layer (410). The second split electrode (425b) and the third split electrode (425c) may be formed to be symmetrical with respect to the base layer (410).

The third split electrode (425c) and the fourth split electrode (425d) can be isolated from each other so as not to be electrically connected to each other.

An opening (422) can be formed facing the split electrode and cutting a portion of the insulating layer (416) to expose a portion of the split electrode to the outside.

The first opening (423a) may face the first split electrode (425a). Similarly, the second opening (423b) to the fifth opening (425e) may face the second split electrode (425b) to the fifth split electrode (425e).

The via hole (411) may include a first via hole (411a) provided at a location of the base layer (410) that does not face the opening (422), or a second via hole (411b) provided at a location of the base layer (410) that faces the opening (422).

Each split electrode can face at least one of the first via hole (411a) and the second via hole (411b).

A fifth segmented electrode (425e) may be provided. The fifth segmented electrode (425e) may be sufficiently provided with one or more openings (425e), and the fifth segmented electrode (425e) may be a reference electrode. Depending on the design, the fifth segmented electrode (425e) may be positioned on the opposite side of the surface where the electrode (424) is intended to have a sufficient area.

The fifth split electrode (425e) can be freely placed in front or behind other split electrodes depending on the design.

If the fifth split electrode (425e) is positioned in front of the other split electrodes (425a, 425c), the leads (427a, 427b) for the fifth split electrode (425e) may be formed along the length direction of the window portion (406) toward the rear of the fifth split electrode (425e). This may be a factor that reduces the area of the other split electrode located behind the fifth split electrode (425e).

If the fifth split electrode (425e) is positioned in front of the other split electrodes (425a, 425c), the fifth split electrode (425e) may be formed to completely fill the distal portion (406), and the fifth split electrode (425e) on the first side may be connected to an electrode on the opposite side, the second side, through a via hole (411). The electrode on the second side connected to the fifth split electrode (425e) may be a dummy electrode or an electrode facing the opening. In either case, a lead may be formed to connect the fifth split electrode (425e) to the rear of the electrochemical sensor (400), and this lead may be a factor that reduces the area for the electrode located on the rear of the electrode on the second side.

If the fifth split electrode (425e) is positioned behind the other split electrodes (425a, 425c), the complex lead wiring for electrically connecting the fifth split electrode (425e) to the middle portion (404) or the proximal portion (402) can be simplified.

The electrode unit (440) may include a split electrode and a split lead. The electrode unit (440) may have a comb-shaped shape, and the split electrodes of the electrode unit (440) may correspond to the teeth of the comb.

The first electrode portion (440a) disposed on the first surface of the distal portion (406) may include a plurality of first split electrodes (425a) and a first split lead (427a) connecting the plurality of first split electrodes (425a).

The second electrode portion (440b) disposed on the second surface of the distal portion (406) may include a plurality of second split electrodes (425b) and a second split lead (427b) connecting the plurality of second split electrodes (425b).

The first split electrode (425a) of the first electrode portion (440a) of the first side and the second split electrode (425b) of the second electrode portion (440b) of the second side can be alternately arranged at positions symmetrical with respect to the base layer (410).

The width of the electrode located at the frontmost part of the distal part (406) among the first split electrode (425a) of the first side and the second split electrode (425b) of the second side may be the same as the width of the distal part (406) except for the edge trench (420b) which is the edge of the electrochemical sensor (400).

When the split electrodes of the comb-shaped first electrode portion (440a) and the second electrode portion (440b) are arranged alternately on opposite sides, the frontmost electrode (425c) of the first side can be connected to the second electrode portion (440b) of the second side through a via hole (411), and the frontmost electrode (425b) of the second side can be a split electrode (425b) belonging to the second electrode portion (440b).

The frontmost electrode (425c) of the first side and the frontmost electrode (425b) of the second side may be electrodes that completely fill the width of the distal portion (406).

Accordingly, when the split electrodes of the comb-shaped first electrode portion (440a) and the second electrode portion (440b) are arranged alternately on opposite sides, at least one of the frontmost electrode of the first side and the frontmost electrode of the second side can be an electrode that fills the width of the distal part (406).

The first split electrode can be any one of the working electrode, the counter electrode, and the reference electrode, and the second split electrode can be any one of the others.

The first split electrode on the first side and the fourth split electrode on the second side may be electrodes of the same type, and the second split electrode on the second side and the third split electrode on the first side may be electrodes of the same type. When an opening is formed in the electrodes on both sides that are connected through a via hole (411), the electrodes on both sides are electrically connected so that the analytes that react in the body can be the same.

The first split electrode (425a) and the fourth split electrode (425d) may be working electrodes, and the second split electrode (425b) and the third split electrode (425c) may be counter electrodes. In this case, working electrodes may be positioned on both sides, and processes such as dispensing to form a selective transmission layer (418) in the opening (422) may be performed on both sides of the electrochemical sensor (400).

When working electrodes are placed on both sides, it can be expected that the reactivity between the working electrode and the analyte in the body will be equal, regardless of the direction of invasion of the distal portion (406) where at least a portion is invaded into the body.

In a second embodiment of the distal portion (406) of the present invention, on one side of the distal portion (406), the first split electrode and the second split electrode may be alternately arranged, and the first split electrode and the second split electrode may not completely fill the width of the distal portion (406).

A split lead may be provided that electrically connects all of the first split electrodes, and the split lead may be positioned around the first split electrode and the second split electrode.

The split lead can extend along the length of the distal portion (406) in parallel with the first split electrode and the second split electrode.

In the case of the second embodiment, the same can be applied as in the first embodiment except that the split leads are provided around all of the alternately repeated split electrodes.

100... Inserter 102... Drive
200... Transmitter 202... Main board
300... needle 310... needle handle
400... Electrochemical sensor 402... Proximal
404... Middle part 405... Folding part
406... distal 410... base layer
411... Via Hall 411a... First Via Hall
411b... 2nd via hole 412... Conductive layer
414... Bonding layer 416... Insulating layer
418... Selective permeable 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... 4th opening 424... electrode
424a... first electrode 424b... second electrode
424c... 3rd electrode 424d... 4th electrode
424e... 5th electrode 425... split electrode
425a... first split electrode 425b... second split electrode
425c... 3rd split electrode 425d... 4th split electrode
426... Lead
426a... 1st lead 426b... 2nd lead
426c... 3rd lead 426d... 4th lead
427... Split lead 427a... First split lead
427b... Second split lead 428... Sensor pad
428a... First sensor pad 428b... Second sensor pad
428c... 3rd sensor pad 428d... 4th sensor pad
430... Conductive Island
430a... 1st conductive island 430b... 2nd conductive island
430c... 3rd conductive island 432... dummy part
432a... 1st dummy section 432b... 2nd dummy section
440... Electrode section 440a... First electrode section
440b... second electrode section
490... Laser head W1,W2... Trench width

Claims (14)

An electrochemical sensor comprising a distal portion having a plurality of electrodes formed thereon that react with an analyte in the body, a proximal portion having sensor pads formed thereon that are connected to the electrodes, and an intermediate portion positioned between the distal portion and the proximal portion;
A main board having at least one of a power supply unit, a communication unit, and a control unit formed thereon, a housing in which the main board is housed, and a transmitter attached to the skin;
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.
In the distal portion, an area is formed in which a first split electrode that fills the width of the distal portion and a second split electrode that does not fill the width of the distal portion are alternately arranged,
Along the width direction of the above-mentioned distal portion, no split lead is formed around the first split electrode, and a split lead is formed around the second split electrode.
A continuous analyte measuring device in which the split lead electrically connects a plurality of the first split electrodes to each other without electrically connecting the second split electrodes.
In the first paragraph,
The first split electrode is provided with one of a working electrode and a counter electrode,
A continuous analyte measuring device in which the second split electrode is equipped with the remainder of a working electrode and a counter electrode.
In the first paragraph,
A continuous analyte measuring device in which two split electrodes are connected by via holes penetrating the base layer for different split electrodes.
delete delete In the first paragraph,
A continuous analyte measuring device in which a first split electrode on a first surface of the distal portion and a first split electrode on a second surface of the distal portion are interconnected by a via hole.
delete delete In the first paragraph,
Between the split lead and the first split electrode, an internal trench is provided to insulate the split lead and the first split electrode from each other.
An edge trench is provided by removing a portion of the conductive layer corresponding to the outer edge of the electrochemical sensor,
The edge trench and the first split electrode are arranged along the width direction of the first split electrode,
A continuous analyte measuring device in which the edge trench, the split lead, the inner trench, and the first split electrode are arranged along the width direction of the second split electrode.
In the first paragraph,
On the second surface of the above-mentioned distal portion, a fourth split electrode is provided that is electrically connected to the first split electrode through a via hole formed to penetrate the base layer.
A continuous analyte measuring device in which the plurality of fourth segmented electrodes on the second side are not electrically connected to each other but are isolated.
In the first paragraph,
The split electrode is exposed to the outside through an opening penetrating the insulating layer,
A continuous analysis material measuring device comprising a first via hole formed to penetrate the base layer and located at a position not facing the opening, and a second via hole provided at a position facing the opening of the first split electrode and the opening of the fourth split electrode.
In the first paragraph,
On the first surface of the above-mentioned distal portion, a first electrode portion is provided, which includes a plurality of first split electrodes and a first split lead connecting the plurality of first split electrodes.
On the second side of the above-mentioned distal portion, a second electrode portion is provided, including a plurality of second split electrodes and a second split lead connecting the plurality of second split electrodes,
A continuous analyte measuring device in which the first electrode section and the second electrode section are comb-shaped.
In the first paragraph,
A continuous analyte measuring device in which the width of the split electrode located at the frontmost part of the distal part is the same as the width of the distal part except for the edge trench which is the edge of the electrochemical sensor.
In the first paragraph,
On the first surface of the above-mentioned distal portion, a first electrode portion is provided, which includes a plurality of first split electrodes and a first split lead connecting the plurality of first split electrodes.
On the second side of the above-mentioned distal portion, a second electrode portion is provided, including a plurality of second split electrodes and a second split lead connecting the plurality of second split electrodes,
On the first surface of the distal portion, a third split electrode is provided that is arranged alternately with the first split electrode, and on the second surface of the distal portion, a fourth split electrode is provided that is arranged alternately with the second split electrode.
The above first split electrode is any one of a working electrode, a counter electrode, and a reference electrode,
The above second split electrode is one of the remaining,
The first split electrode of the first side and the fourth split electrode of the second side are electrodes of the same type,
A continuous analyte measuring device in which the second split electrode of the second side and the third split electrode of the first side are electrodes of the same type.