WO2023229134A1 - Continuous analyte meter, and method for attaching conductive patch - Google Patents

Abstract

A continuous analyte meter of the present invention may comprise: an electrochemical sensor including a distal portion having a plurality of electrodes which react with an analyte in the body, and a proximal portion having a sensor pad connected to the electrodes; a transmitter including a main substrate on which at least one of a power supply unit, a communication unit, and a control unit is formed and a contact pad is provided, and a housing in which the main substrate is accommodated, the transmitter being configured to be attached to the skin; a needle having an exposed portion on which the distal portion of the electrochemical sensor is disposed, the exposed portion being formed along the longitudinal direction; an inserter for advancing the transmitter and the needle from a first location to a second location to insert the needle and the distal portion into the skin, and retracting the needle from the second location to a third location when the transmitter is attached to the skin; and a pad connection unit for electrically connecting the transmitter to the electrochemical sensor.

Description

Continuous analyte meter and conductive patch attachment method

The present invention relates to a continuous analyte measuring device using an electrochemical sensor that can continuously measure analytes such as glucose, at least partially invasive into the body, and a method of attaching a conductive patch that electrically connects the electrochemical sensor and the transmitter. .

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 transmitter may be placed inside the insert along with an electrochemical sensor before being attached to the skin. A type in which a transmitter and an electrochemical sensor are pre-combined can be called an all-in-one type transmitter.

For electrical connection between the sensor and the main board of the transmitter, a method of inserting the proximal part into the connector of the main board, a method of soldering the proximal part to the main board, a method of bonding the proximal part to the main board, and a method of surface mounting the proximal part to the main board. , a method of integrating the proximal part to the main board with a conductive fixing member (metal rivet, etc.), a method of sandwiching the proximal part to the main board, etc. may be used.

Meanwhile, electrochemical sensors must have good flexibility, small size, small width, and thin thickness to relieve pain when inserted into the body and reduce foreign body sensation when worn. Electrochemical sensors must be flexible and thin enough that they cannot be inserted into the skin alone without a needle to relieve pain and reduce the sensation of a foreign body.

At this time, the more flexible the electrochemical sensor is and the smaller its thickness and size, the more difficult it is to make an electrical connection with the main board. Inserting the connector is impossible, contact defects are likely to occur, and physical contact of the contact point may result in scratches or poor measurement. .

The electrochemical sensor that is energized with the transmitter through the pad connection of the present invention may include a flexible base layer to relieve pain and reduce foreign body sensation.

The sensor pad of the electrochemical sensor of the present invention may be electrically connected to the contact pad of the transmitter through a conductive patch having electrical anisotropy and adhesiveness.

The continuous analyte measuring device of the present invention includes an electrochemical sensor including a distal portion formed with a plurality of electrodes that react with analytes in the body and a proximal portion formed with a sensor pad connected to the electrodes; A transmitter including a main board formed with at least one of a power source, a communication part, and a control part and provided with a contact pad, a housing in which the main board is stored, and attached to the skin; a needle having a distal portion of the electrochemical sensor disposed in an exposed portion along the longitudinal direction; an inserter that advances the transmitter and the needle from a first position to a second position to insert the needle and the distal portion into the skin, and retracts the needle from the second position to a third position when the transmitter is attached to the skin; a pad connection portion electrically connecting the electrochemical sensor and the transmitter; may include.

According to the conductive patch attachment method of the present invention, in order to electrically connect the sensor pad of the electrochemical sensor and the contact pad of the main board inside the transmitter, the conductive patch goes through a first adhesion step and a second adhesion step to the sensor pad and Can be glued between contact pads.

When connecting an electrochemical sensor to the transmitter's main board, soldering with lead may cause heat burning of the FPC or PET type electrochemical sensor.

Meanwhile, even when soldering using the surface mounting process, if the soldering paste is heated to a temperature that melts, the polyimide and PET that make up the thin sensor may suffer thermal damage.

Even when connecting sensors using adhesive, the adhesive can act as a foreign substance that interferes with the conduction of electricity between the sensor pad and the contact pad of the transmitter.

Meanwhile, even when connecting the end of the sensor to the connector, insertion of the sensor into the connector may be impossible because the thickness or rigidity of the sensor is too small.

The present invention to solve this problem can present electrical connection by a conductive patch as almost the only alternative.

The pad connection portion or conductive patch of the present invention may have conductivity that conducts electricity in the direction in which adhesive pressure is applied, and may have non-conductivity that does not conduct electricity along the longitudinal direction of the conductive patch perpendicular to the direction of electrical conduction. there is.

When the conductive patch of the present invention is subjected to pressure or heat between the sensor proximal portion and the contact pad, alternating conductive and non-conductive regions along the length may be formed in the conductive patch.

In the present invention, when the sensor pad and the contact pad of the main board are directly connected with a conductive patch, a separate connector connecting the sensor to the main board may not be necessary. The electrochemical sensor of the present invention can be firmly bonded to the main substrate as if glued. Even in a vibration environment, such as when attached to a body part that moves a lot, the reliability of the electrical connection between the electrochemical sensor and the main board can be maintained at a high level.

The conductive patch of the present invention can have a thickness as thin as tens of microns. The proximal part of the sensor, the conductive patch, and the main board connection may have a bonding structure with an overall thin thickness. Because of this, the internal structure of the transmitter attached to the body can be simplified and the overall size of the transmitter can be minimized.

The connection part of the electrochemical sensor including the conductive patch of the present invention has a relatively simple manufacturing process compared to using a separate connector structure, so it can be easily converted to an automated process and mass produced.

1 is a cross-sectional view of the continuous analyte measuring device of the present invention.

Figure 2 is a cross-sectional view of the transmitter of the present invention.

Figure 3 is an enlarged view of area A of Figure 2.

Figure 4 is a diagram illustrating the adhesion of the conductive patch of the present invention.

Figure 5 is a top and rear view of the electrochemical sensor of the present invention.

Hereinafter, the case where the electrochemical sensor 100 of the present invention is used as a continuous glucose monitoring system (CGMS) to measure interstitial fluid or blood glucose concentration will be described as an example. However, the electrochemical sensor 100 of the present invention is not limited to measuring glucose concentration in the body and can be extended to a continuous analyte meter that measures other biomarkers.

<Electrochemical sensor>

Referring to FIG. 5, the electrochemical sensor 100 of the present invention may include a distal part 200, at least a portion of which can be invaded into the body, and a proximal part 400, which can be connected to an electric circuit such as a power source.

Infiltration may mean inserting at least a portion of the distal portion 200 of the electrochemical sensor 100 into the body.

An electrode 210 including at least one of a working electrode, a counter electrode, and a reference electrode may be formed in the distal portion 200. A sensor pad 420 connected to the electrode 210 may be formed in the proximal portion 400.

Figure 5 shows a case where electrodes 210 are formed on both sides of the distal portion 200. Figure 5(a) shows one side of the electrochemical sensor 100, and Figure 5(b) shows the other side of the electrochemical sensor 100.

The electrochemical sensor 100 may include a base layer 110 that is flexible enough to prevent skin invasion by itself without a needle. The base layer 110 may include at least one of synthetic resin, polyimide (PI), and polyethylene terephthalate (PET) as an insulating material.

The current generated through an electrochemical reaction with glucose in the body in the distal part 200 may be connected to the conductive plate 400 in the proximal part 400 along the lead wire 300 laminated on the base layer 110. The sensor pad 420 formed on a portion of the conductive plate 400 may be electrically connected to the main board 610 of the transmitter 600.

In the electrochemical sensor 100, a conductive layer may be formed on the base layer 110 using a method such as sputtering. In the electrochemical sensor 100, an insulating layer may be formed after forming the conductive layer.

The sensor pad 420 or electrode 210 may be formed by exposing a portion of the conductive layer below the insulating layer to the outside through a hole in the insulating layer. The sensor pad 420 of the proximal portion 400 may be formed only on one surface of the proximal portion 400 so that the proximal portion 400 can contact the main board 610 .

The distal part 200 may include an electrode 210 that can be inserted into the body and perform a glucose oxidation or reduction reaction. The electrode 210 may include at least one of a working electrode, a counter electrode, and a reference electrode.

When voltage is applied to the electrode 210 of the present invention, glucose in the body can undergo an oxidation-reduction reaction, and current can flow due to the electrons generated at this time. The generated current can be determined according to the glucose concentration in the body, allowing the signal of biomarkers, including blood sugar levels, to be quantified.

The electrochemical sensor 100 needs 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 100 decreases, the area of the electrode 210 formed on the distal portion 200 may also decrease. If the area of the electrode 210 is not sufficiently secured, signal disturbance due to noise may occur, so when manufacturing the electrochemical sensor 100, there is a trade-off relationship between reducing the size of the sensor 100 and securing the area of the electrode 210. We need to satisfy everyone.

In one embodiment, the electrode 210 of the present invention may be formed on both sides of the distal portion 400. In order to minimize the size of the invading distal part 200 and secure sufficient electrode placement space, the electrode 210 located in the distal part 400 of the electrochemical sensor 100 invading the body is placed on both sides of the base layer 110. It can be placed.

In another embodiment, the electrode 210 of the present invention may be formed only on one side of the distal portion 400. When the electrode 210 is formed on only one side of the distal part 400, the manufacturing and design of the electrochemical sensor 100 may be simplified, but the structure of the distal part 200 may become complicated due to the plurality of electrodes and lead wires. , it may be difficult to reduce the size of the electrochemical sensor 100.

At least one electrode 210 may be disposed on one side or the other side of the base layer 110 of the distal portion 400. The double-sided type electrode 210 may include an upper electrode 212 formed on the upper surface 112 of the base layer and a lower electrode 214 formed on the lower surface 114 of the base layer.

The upper electrode 212 and the lower electrode 214 may include at least one working electrode and one reference electrode. The counter electrode may include a plurality of first counter electrodes and second counter electrodes as needed. The counter electrode may be provided as three or more electrodes including a reference electrode and a working electrode for precise data acquisition.

The surface of the working electrode may be a porous platinum electrode, and the surface may be formed by applying porous platinum collide.

The reference electrode may be an electrode that applies a reference potential. The reference electrode may be one of a silver chloride electrode (Ag/AgCl), a calomel electrode, or a mercury (I) sulfate electrode. When the biomarker is glucose, a silver chloride electrode (Ag/AgCl) may be preferred as the reference electrode.

The proximal portion 400 may include an upper conductive plate 402 formed on the upper surface 112 of the base layer, or a lower conductive plate 404 formed on the lower surface 114 of the base layer.

As an example, a case where the sensor pad 420 is formed on the upper surface 112 of the base layer of the proximal portion 400 will be described. The upper electrode 212 of the distal part 200 may extend along the upper surface 112 of the base layer through the upper lead wire 302 and be connected to the upper conductive plate 402 of the proximal part 400. The lower electrode 304 of the distal part 200 may extend along the lower surface 114 of the base layer through the lower lead wire 304 and be connected to the lower conductive plate 404 of the proximal part 400.

In one embodiment, two upper electrodes 212 and two lower electrodes 214 may be formed. The two upper electrodes 212 may be respectively connected to the upper conductive plate 402 and the two lower electrodes 214 may be respectively connected to the lower conductive plate 404.

If the sensor pad 420 is formed on both the upper conductive plate 402 and the lower conductive plate 404, the lead wire 300 arrangement can be simplified, but the connection structure between the sensor pad 420 and the external circuit is complicated. It can happen. Figure 5 shows a case where the sensor pad 420 of the present invention is disposed on one surface of the proximal portion 400.

The electrode 210 may be formed on both sides of the distal portion 200 and the through hole 120 may be provided in the base layer 110 so that the sensor pad 420 may be formed on only one side of the proximal portion 400. The upper surface 112 of the base layer and the lower surface 114 of the base layer may be electrically connected through the through hole 120. That is, the upper conductive plate 402 and the lower conductive plate 404 are energized by the through hole 120, so that despite the double-sided electrode arrangement on the distal portion 200, the sensor pad 420 is connected to one side of the proximal portion 400. can be placed in

The through hole 120 may be formed in at least one of the proximal part 400 and the distal part 200.

When the through hole 120 is formed in the proximal part 400, sensor pads 420 that are connected to and differentiated from different types of electrodes disposed in the distal part 200 can be placed on one side of the proximal part 400. .

When the through hole 120 is formed in the distal part 400, the electrodes 210 disposed on both sides of the distal part 400 are connected by the through hole 120 of the distal part 400 and are the same type of electrode. It can be (210).

When double-sided electrodes are placed on the distal part 200, both sides of the distal part 200 inserted into the body can react with substances in the body, so the sensitivity of the electrochemical sensor 100 can be increased.

Since at least a portion of the distal part 200 is inserted into the body, if the width of the distal part 200 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, 400㎛) or less. If all three or more electrodes 210 are placed on only one side of the distal part 200 that invades the body, the width of the distal part 200 may be widened to secure space for the three or more electrodes and the lead wire 300 connected to them. .

The length at which the invasive electrochemical sensor 100 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 200 may range from 100 to 500 micrometers. The thickness of the invaded portion of distal portion 200 may range from 10 to 500 micrometers.

Therefore, when all three or more electrodes are placed on one side of the base layer and the insertion width of the distal part is reduced to less than a predetermined insertion width, the defect rate due to short circuit between the electrodes 210 or lead wires 300 may increase.

When four or more electrodes 210 are used in the distal portion 200, a double-sided electrode arrangement may be better than a single-sided electrode arrangement. Even when using three or less electrodes, the double-sided electrode arrangement makes it easier to secure space for the lead wire 300, electrode 210, or conductive plates 402 and 404 compared to the single-sided electrode arrangement, and can reduce the defect rate such as short circuit. The width and length of the distal part inserted into the body can be reduced, and the misalignment rate can be reduced when forming an insulating layer.

<insert>

Referring to FIG. 1, the electrochemical sensor 100 of the present invention can be attached to the skin together with the transmitter 600. The transmitter 600 can control the signal measured by the electrochemical sensor 100 and can transmit continuously measured blood sugar levels to an external terminal or mobile phone.

The state in which the electrochemical sensor 100 and the transmitter 600 are provided at the first position inside the inserter may be referred to as the initial state. A state in which the electrochemical sensor 100 or the transmitter 600 moves from the first position of the inserter and is attached to the skin at the second position may be referred to as an attached state.

In the initial state, the inserter may include an electrochemical sensor 100 and a transmitter 600 therein. In the attached state, the transmitter 600 may be attached to the skin surface, and at least a portion of the electrochemical sensor 100 may be invasive into the skin.

The transmitter 600 and the electrochemical sensor 100 may be provided to the user in a state in which they are already electrically connected through a pad connection part, which will be described later, before attachment to the skin.

Since the needle 620 and the electrochemical sensor 100 inside the inserter are inserted into the human body, for sterilization, the cap member 504 may be provided to the user with the internal parts of the inserter wrapped. The user may remove cap member 504 before attaching transmitter 600 to the skin.

A protective portion 680 capable of retaining the distal portion 200 and the needle 620 therein may be provided on the cap member 504. Protective portion 680 may be removed along with cap member 504.

When a user's action is applied to the inserter, the transmitter 600 and the electrochemical sensor 100 mounted inside the inserter may move toward the skin.

The initial state can be converted to an attached state through a driving state. In the driving state, relative movement between members of the inserter may occur.

The inserter may include a skin fixation part 520 that is exposed when the cap member 504 is removed, and an upper cylinder 510 that moves relative to the skin fixation part 520.

The transmitter 600 may be located in a first position in the initial state, the transmitter 600 may move from the first position to the second position in the driving state, and the transmitter 600 in the second position may be attached to the skin. You can. The insertion direction may be from the first position to the second position.

The inserter may include a transmitter support 540. The transmitter support 540 holds the transmitter 600 in the air and can move the transmitter 600 from a first position to a second position.

The inserter may advance the transmitter 600 or needle 620 from a first position to a second position such that the needle 620 penetrates the user's skin.

The electrochemical sensor 100 may be disposed on an exposed portion of the needle 620 along its length. The distal part 200 of the sensor 100 is flexible enough to be difficult to penetrate the skin alone, so it can be inserted into the skin together with the needle 620.

A needle handle 640 to which the needle 620 is fixed may be provided. When assembling the needle 620 into the inserter, the needle handle 640 on the upper part of the needle 620 may be attached to or detached from the return member 560. The transmitter support 540 operates by a driving means such as a user's manual operation, spring, hydraulic pressure, pneumatics, motor, electric actuator, etc., and the transmitter support 540 moves the transmitter 600 and the sensor 100 at the second position. It can adhere to the skin.

The return member 560 may be operated by a driving means such as a user's manual operation, spring, hydraulic pressure, pneumatic pressure, motor, or electric actuator. The return member 560 may retract the needle 620 in the second position to the third position along a direction opposite to the insertion direction.

A locking portion that elastically locks the return member 560 may be formed on the transmitter support 540. In a state where the locking portion of the transmitter support 540 locks the return member 560, the return member 560 and the transmitter support 540 may move together from the first position to the second position.

When the transmitter 600 reaches the second position, the elastic locking of the locking portion with respect to the return member 560 is released, the transmitter support 540 remains in the second position together with the transmitter 600, and the return member 560 ) can retract the needle 630 to the third position.

An elastic member 562 whose one end and the other end are supported between the return member 560 and the transmitter support 540 may serve as a driving means for return. The elastic member 562 may be in a compressed state while moving from the first position to the second position.

When the lock on the return member 560 of the transmitter support 540 is released, the elastic member 562 explodes and the return member 560 can be raised. The needle 620 may retract and be separated from the transmitter 600 and the electrochemical sensor 100 after the transmitter 600 and the electrochemical sensor 100 are attached to the skin.

<Transmitter>

Figure 2 may be a cross-sectional view of the transmitter 600, needle handle 640, needle 620, and electrochemical sensor 100 combined.

The direction in which the electrochemical sensor 100 is aligned by the needle 620 may be perpendicular to the horizontal direction in which the transmitter 600 is attached to the skin. The distal portion 200 of the electrochemical sensor 100 may be located inside the exposed portion of the needle 620. Needle 620 can be lifted perpendicular to transmitter 600.

In an embodiment in which through holes of the needle 620 are formed in the upper and lower parts of the transmitter 600, the needle 620 passes through the through hole formed in the upper lid and the lower lid of the transmitter 600, It may be separated from the transmitter 600.

The distal part 200 of the electrochemical sensor 100 is exposed to the recessed part of the transmitter 600 and can be inserted into the skin while being guided inside the needle 620.

The proximal portion 400 of the electrochemical sensor 100 may be exposed to a recess outside the transmitter 600 through a gap between the upper and lower lids of the transmitter 600.

A sealing portion 660 may be provided in the gap between the upper and lower lids of the transmitter 600, where a portion of the electrochemical sensor 100 is inserted and pressed. The sealing portion 660 may include at least one of adhesive, tape, rubber pad, and O-ring inserted between the upper and lower lids of the transmitter 600. The transmitter 600 can be waterproofed from the outside by the sealing part 660.

As another example, if no through hole for the needle 620 is formed in the transmitter 600, the waterproofness can be improved. If the transmitter 600 does not have a through hole for the needle 620, a depression may be formed in the side direction of the upper and lower lids of the transmitter 600. When viewed from the top of the transmitter 600, the needle 620 is located in a depression that is an open space, and the needle 620 can be raised and lowered in the depression outside the transmitter 600. The needle 620 and needle handle 640 can be lifted up and down in a depression outside the transmitter 600.

An internal space may be provided between the upper lid and lower lid of the transmitter 600. The main board 610 may be seated in the internal space of the transmitter 600.

At least one of a control unit, a battery, an operational amplifier, a wireless communication unit, and a contact pad may be installed on the main board 610.

The battery can supply a bias voltage that can cause an electrochemical reaction in the working electrode. The signal measured at the distal portion 200 may be amplified by an operational amplifier. The magnitude of the output current for a given bias on the working electrode may be a measure of the concentration of an analyte, such as glucose, in the vicinity of electrode 210. The control unit can calculate or control the electrical signals of the sensor.

<Pad connection and conductive patch>

*Figure 3 may be an enlarged view of area A of Figure 2.

Referring to FIG. 3, one side of the electrochemical sensor 100 on which the sensor pad 420 is formed may face the main board 610, and the other side of the electrochemical sensor 100 may be in the internal space of the transmitter 600. may be exposed.

A pad connection may be provided in the transmitter 600. The pad connection may include at least one of the proximal portion 400, the sensor pad 420, and the conductive patch 700.

The conductive patch 700 may include conductive particles 720 and a non-conductive member 740 in which the conductive particles 720 are distributed.

The sensor pad 420 may be formed only on one surface of the proximal portion 400 of the electrochemical sensor 100. The contact pad 612 electrically connected to the sensor pad 420 may be formed on one surface of the main board 610.

On one side of the main board 610, there is a power supply such as a battery required to measure the glucose concentration of the distal part 200, a control unit including an electric circuit, and a control unit that controls the data measured by the electrochemical sensor 100 and wirelessly transmits it to the outside. At least one of the communication units for transmission may be surface mounted.

One side of the main board 610 may be exposed to the internal space of the housing of the transmitter 600, and the other side of the main board 610 may face the lower surface of the transmitter 600.

The sensor pad 420 and the contact pad 612 may face each other with the conductive patch 700 therebetween.

Proximal portion 400, conductive patch 700, and contact pad 612 may be in planar contact with each other. The main board connection part may include a contact pad 612, and the contact pad 612 may be in contact with one surface of the conductive patch 700.

In order to relieve pain and reduce foreign body sensation, the electrochemical sensor 100 is much thinner and thinner than a general FPC, so it may be difficult to connect the electrochemical sensor 100 with a connector for general FPC connection. The present invention can directly connect the electrochemical sensor 100 to the main board 610 using the conductive patch 700.

The electrochemical sensor 100 is thin enough to be difficult to penetrate the skin on its own. If the electrochemical sensor 100 is flexible and reduced in size to relieve pain during invasion and reduce foreign body sensation when worn, contact defects are likely to occur between the sensor pad 420 and the contact pad 612, and contact defects may cause Scratches may occur. The proximal portion 400 may be so weak that it is impossible to physically insert or sandwich into the connector.

The conductive patch 700 used for electrical connection of the electrochemical sensor 100 may have a thickness of several tens of microns.

The conductive patch 700 may have a thickness ranging from 10 to 50 ㎛, preferably 23 to 27 ㎛. The diameter of the conductive particles 720 may be 10 to 50 ㎛, preferably 18 to 22 ㎛. The distribution concentration of the conductive particles 720 may be 50 to 500 pcs/mm2, and preferably 100 to 300 pcs/mm2.

The sensor pad 420 may be formed only on one surface of the proximal portion 400 of the electrochemical sensor 100. The contact pad 612 may be formed only on one side of the main substrate 610. The conductive patch 700 may be positioned between one surface of the proximal portion 400 on which the sensor pad 420 is formed and one surface of the main substrate 610 on which the contact pad 612 is formed.

Accordingly, the proximal portion 400 of the electrochemical sensor 100, the conductive patch 700, and the contact pad 612 may be very thin overall. Because of this, the thickness and size of the transmitter 600 attached to the body can be minimized.

Figures 4 (a), (b), and (c) may sequentially show the process in which the electrochemical sensor 100, the conductive patch 700, and the main substrate 610 are pressed and bonded to each other.

Referring to FIG. 4, the sensor pad 420 of the electrochemical sensor 100 may be electrically connected to the contact pad 612 of the transmitter 600 through the conductive patch 700.

When pressure or heat is applied to the conductive patch 700, the shape of the conductive particle 720 may be deformed.

When pressure or heat is applied to the conductive patch 700, the conductive particles 720 may adhere to the sensor pad 420 or the contact pad 612 in the direction in which the pressure or heat is applied.

When the conductive patch 700 is subjected to pressure or heat between the proximal portion 400 and the contact pad 612, the conductive patch 700 forms a conductive region 722 along a longitudinal direction perpendicular to the direction in which the pressure or heat is applied. and non-conductive regions 742 may be alternately repeated.

When pressure or heat is applied to the conductive patch 700, the sensor pad 420 is electrically moved along the direction in which the pressure or heat is applied through the contact pad 612 and the conductive particles 720 of the conductive patch 700. It can be connected.

When pressure or heat is applied to the conductive patch 700, the conductive patch 700 may not be electrically conductive along a longitudinal direction perpendicular to the direction in which the pressure or heat is applied.

Specifically, the conductive particle 720 may electrically connect the first sensor pad and the first contact pad, and the non-conductive member 740 may electrically insulate the first sensor pad from the second sensor pad and the second contact pad. You can do it.

When the proximal portion 400 including the sensor pad 420, the conductive patch 700, and the contact pad 612 are in plane contact, the conductive patch 700 does not conduct electricity in the plane extension direction, and the conductive patch 700 does not conduct electricity in the plane extension direction. Electricity can flow in a direction perpendicular to .

Conductivity along the pressing direction of the conductive patch 700 may not occur before the conductive patch 700 is compressed, and may occur after the conductive patch 700 is compressed. That is, the conductive patch 700 is not conductive before being compressed by pressure or heat, and the conductive patch 700 may be conductive in the direction of compression after being compressed by pressure or heat.

The conductive particles 720 inside the non-conductive member 740 may be distributed considering the conductivity of the conductive patch 700 along the pressing direction after being pressed against the conductive patch 700.

A plurality of conductive regions including the sensor pad 420 and the contact pad 612 formed after compression may be formed. The conductive particles 720 may be distributed at a uniform concentration in the non-conductive member 740 so that the plurality of conductive regions have the same electrical characteristics.

The conductive particles 720 may have a spherical shape or a dendrite shape.

The material of the conductive particles 720 may include at least one of polymer, nickel, and gold. For example, conductive particles 720 may be composed of polymer, nickel, and gold. Conductive particles 720 may be composed of nickel and gold. Conductive particles 720 may be composed of polymer, nickel, gold, and an insulating film.

The conductive particles 720 may include a polymer containing plastic as a core, or a conductive layer coated on the polymer. The conductive layer of the conductive particle 720 may include a metal material including nickel (Ni) or gold (Au). The thickness of the conductive layer formed of nickel or gold may be 30 to 150 nm.

The composition of the conductive particles 720 may be determined depending on the material of the object to which the conductive patch 700 is attached.

The conductive particles 720 may include a polymer coated with a conductive layer containing gold or nickel. In this case, the conductive particles 720 can reduce damage to the substrate due to their uniform size and soft characteristics, and can be interconnected at a fine pitch.

Conductive particles 720 made of nickel coated with nickel or gold can be used in PCB or PDP substrates due to their wide size distribution and hard properties.

The non-conductive member 740 may be compressed and melted under predetermined heat or pressure conditions. The compressed non-conductive member 740 may be filled in the non-conductive area 742 to prevent electrical conduction between the conductive areas 722.

The conductive patch 700 may include an anisotropic conductive film (ACF). The conductive patch 700 may be made by uniformly dispersing fine conductive particles 720 in adhesive resin. When the conductive patch 700 is thermally compressed, the resin 740 is hardened so that the sensor pad 420 of the proximal portion 400 can be fixed to the main board 610.

The size or distribution of the conductive particles 720 may be adjusted depending on the size of the conductive area 722. If the size of the conductive particle 720 is too large compared to the conductive area 722, a short circuit may occur between adjacent conductive areas 722, and if the size of the conductive particle 720 is too small compared to the conductive area 722 , the conductive region 722 may not be properly connected or conductivity may be uneven between the plurality of conductive regions 722.

The cross-sectional area capable of maintaining contact reliability of the conductive region 722 may be 100,000 ㎛ ² to 200,000 ㎛ ² , and preferably 150,000 ㎛ ² .

The length between the conductive regions 722 that can maintain the contact reliability of the conductive regions 722 may be 100 ㎛ to 500 ㎛, and preferably 200 ㎛.

The manufacturing process of the conductive patch 700 may include at least one of mixing, coating, slitting, and packaging.

The conductive patch 700 may be manufactured by uniformly mixing at least one of a non-conductive member 740 containing a resin, conductive particles 720 containing conductive particles, a curing agent, and an additive.

Mixed materials such as formulations can be applied to the separator in a uniform thickness and coated with the mixture in the mixing process. During the mixing process, the coated mixture may be dried using a method such as drying.

The coated mixture may be slitted after the mixing process, packaged in a reel, and provided to the user.

The electrochemical sensor 100 may be provided to the user while attached to the transmitter 600 through a conductive patch 700.

As another example, a bridge board that serves as a bridge connecting the electrochemical sensor 100 and the main board 610 may be additionally provided. The bridge board, like a general FPC, can have sufficient rigidity and thickness to allow connector insertion. One end of the bridge board and the sensor pad 420 may be electrically connected by a conductive patch 700, and the other end of the bridge board and the main board 610 may be electrically connected by physical contact such as a general connector.

One end of the bridge board may be connected to the sensor pad 420. One end of the bridge substrate may be adhesively connected to the sensor pad 420 using conductive particles 720 and non-conductive members 740.

The other end of the bridge substrate may be connected to the contact pad 612. The other end of the bridge board may be connected to one end of the connector by a physical assembly method, such as being inserted into a general connector or sandwiched between a plurality of members constituting the connector. The other end of the connector may be electrically connected to the contact pad 612. As a result, the sensor pad 420 may be electrically connected to the board terminal 612 through a connector and a bridge board.

For example, for pain relief, the thickness of the electrochemical sensor 100 is less than 100 micrometers and it is flexible enough to be impossible to insert into the skin without a needle. The width of the distal part inserted into the human body is less than 500 micrometers, and the width of the proximal part to be connected to the main board is unlikely to exceed twice that of the distal part. If the difference in width between the distal part and the proximal part is too large, it is difficult to smoothly change the width within 3 cm of the total length of the electrochemical sensor 100, and a sudden change in curvature may cause the sensor to tear. As a result, the electrochemical sensor 100, which has a very small width and thickness, may have very difficult electrical connection to the main board.

The conductive patch 700 of the present invention can be attached between the main board and the proximal sensor pad 420, which has a very small width and thickness.

As another embodiment to improve the degree of freedom of connection, a bridge board of general FPC specifications can be used between the main board and the electrochemical sensor 100. In this case, either the conductive patch 700 is used between the proximal sensor pad 420 and the bridge board, the conductive patch 700 is used between the contact pad of the main board and the bridge board, or the conductive patch 700 is used in the middle part of the bridge board. Patch 700 may be used.

<How to attach a conductive patch>

The adhesion step of the sensor pad 420, the conductive patch 700, and the contact pad 612 may include a first adhesion step or a second adhesion step.

The first adhesion step may be a step of attaching one side of the conductive patch 700 to either the sensor pad 420 or the contact pad 612.

After the first adhesion step, a step of removing the release paper attached to the conductive patch 700 may be additionally included. The remaining one of the sensor pad 420 or the contact pad 612 may be attached to the conductive patch 700 from which the release paper has been removed in a second adhesion step.

For example, the first adhesion step may be a step of attaching one side of the conductive patch 700 to the sensor pad 420 or the contact pad 612 at a first temperature or first pressure for a first time. The second adhesion step may attach the other side of the conductive patch 700 to the remaining one of the sensor pad 420 or the contact pad 612 at a second temperature or a second pressure for a second time.

The adhesion temperature of the first adhesion step may be lower than the adhesion temperature of the second adhesion step. The adhesion time of the first adhesion step may be shorter than the adhesion time of the second adhesion step. The adhesion pressure of the first adhesion step may be lower than that of the second adhesion step.

The adhesion temperature in the first adhesion step may be 50 to 150°C, preferably 70 to 90°C. The adhesion time of the first adhesion step is 0.5 to 10 sec. It may be, preferably 1 to 3 sec. It can be. The adhesion pressure in the first adhesion step may be 0.3 Mpa to 3 Mpa, and preferably may be 1 Mpa or a value close to 1 Mpa or more than 1 Mpa.

The adhesion temperature in the second adhesion step may be 50 to 300°C, preferably 150 to 160°C. The adhesion time of the second adhesion step is 5 to 30 sec. It may be, preferably 10 to 15 sec. It can be. The adhesion pressure in the first adhesion step may be 0.5 to 5 Mpa, preferably 1.5 to 2.5 Mpa.

The lower surface of the transmitter 600, the main substrate 610, the conductive patch 700, and the proximal portion 400 of the sensor 100 may be seated in order along the vertical direction. In this case, in the first adhesion step, the conductive patch 700 may be seated and adhered to the top of the main substrate 610 or the contact pad 612. After the first adhesion step, the release paper attached to the upper surface of the conductive patch 700 can be removed. A second adhesion step may be performed after aligning the sensor pad 420 and the contact pad 612.

Claims (16)

An electrochemical sensor comprising a distal part formed with a plurality of electrodes that react with analytes in the body and a proximal part formed with a sensor pad connected to the electrodes; A transmitter including a main board formed with at least one of a power source, a communication part, and a control part and provided with a contact pad, a housing in which the main board is stored, and attached to the skin; a needle having a distal portion of the electrochemical sensor disposed in an exposed portion along the longitudinal direction; an inserter that advances the transmitter and the needle from a first position to a second position to insert the needle and the distal portion into the skin, and retracts the needle from the second position to a third position when the transmitter is attached to the skin; a pad connection portion electrically connecting the electrochemical sensor and the transmitter; A continuous analyte meter comprising a. According to claim 1, The pad connection is non-conductive before compression by pressure or heat, and is conductive in the direction of compression after compression by pressure or heat. According to claim 1, The pad connection portion is provided between the sensor pad and the contact pad, The pad connection portion is not electrically conductive along a direction perpendicular to the direction in which the pad connection portion is compressed, but is electrically conductive along the direction in which the pad connection portion is compressed. According to claim 1, When pressure or heat is applied to the pad connection part, A continuous analyte measuring device in which conductive regions and non-conductive regions are alternately repeated at the pad connection portion along the width and length directions perpendicular to the height direction to which the pressure or heat is applied. According to claim 1, The first sensor pad and the first contact pad face each other, A second sensor pad spaced apart from the first sensor pad faces a second contact pad, The pad connection portion includes a conductive patch, The conductive patch is a continuous analyte measuring device including a non-conductive member and a plurality of conductive particles distributed inside the non-conductive member in a spaced apart state. According to claim 1, The pad connection portion includes a conductive patch, The conductive patch includes a non-conductive member and a plurality of conductive particles distributed inside the non-conductive member while being spaced apart from each other, When pressure or heat is applied to the conductive patch, the conductive particles are deformed, The conductive particles electrically connect the first sensor pad and the first contact pad, The non-conductive member electrically insulates the first sensor pad or first contact pad from the second sensor pad and the second contact pad. According to claim 1, The pad connection portion includes a conductive patch, The conductive patch is a continuous analyte measuring device including a non-conductive member and a plurality of conductive particles distributed inside the non-conductive member in a spaced apart state. According to claim 1, The pad connection portion includes a conductive patch, The conductive patch includes a non-conductive member and a plurality of conductive particles distributed inside the non-conductive member while being spaced apart from each other, When pressure or heat is applied to the conductive patch, the conductive particles located between the sensor pad and the contact pad are deformed and broken, and the conductive particles located between the adjacent sensor pad and the adjacent contact pad are not deformed or broken. water meter. According to claim 1, The pad connection portion includes a conductive patch, The conductive patch includes a non-conductive member and a plurality of conductive particles distributed inside the non-conductive member while being spaced apart from each other, A continuous analyte meter in which at least one of the sensor pad and the contact pad protrudes embossedly toward each other so that the conductive particles are broken and conductive in the direction in which they are pressed. According to claim 1, The pad connection portion includes a conductive patch, The conductive patch is made by dispersing fine conductive particles in adhesive resin, A continuous analyte measuring device wherein the material of the conductive particles includes at least one of polymer, nickel, and gold. According to claim 1, The pad connection portion includes a conductive patch, The thickness of the conductive patch is 10 to 50 ㎛, The conductive particles included in the conductive patch are spherical or dendrite-shaped, A continuous analyte measuring device wherein the conductive particles have a diameter of 10 to 50 ㎛. According to claim 1, The pad connection portion includes a conductive patch, The cross-sectional area of the conductive area formed by the conductive particles included in the conductive patch is 100,000 ㎛ ² to 200,000 ㎛ ² , The separation length between the conductive regions is 100 ㎛ to 500 ㎛, A continuous analyte measuring device in which the distribution concentration of conductive particles on the conductive patch is 50 to 500 pcs/mm2. In order to electrically connect the sensor pad of the electrochemical sensor and the contact pad of the main board inside the transmitter, the conductive patch is bonded between the sensor pad and the contact pad through a first adhesion step and a second adhesion step. . According to claim 13, The first adhesion step is a step of attaching one side of the conductive patch to the sensor pad or contact pad at a first temperature or first pressure for a first time, The second adhesion step is a method of attaching a conductive patch wherein the other side of the conductive patch is attached to the remaining one of the sensor pad or the contact pad at a second temperature or a second pressure for a second time. According to claim 14, At least one of the first temperature, first pressure, and first time, A method of attaching a conductive patch that is lower or smaller than at least one of the second temperature, second pressure, and second time. According to claim 13, After the first adhesion step, further comprising removing the release paper attached to the conductive patch, A method of attaching a conductive patch in which the sensor pad or contact pad of the second adhesive step is attached to the conductive patch from which the release paper has been removed.

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