KR20240010166A - Continuous anaylyte measurement device and electrochemical sensor Connection Method By Local Heating Portion - Google Patents

Abstract

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 comprising a main board in which at least one of a power supply unit, a communication unit, and a control unit is surface mounted, and a housing in which the main board is stored, where a board pad is formed on the main board and the housing is attached to the skin. ; In a state where the needle and the distal part are inserted into the body together, measurement of the analyte is performed, and after the skin is incised by the needle, the distal part of the electrochemical sensor is inserted into the body, and face each other. When the soldering paste between the sensor pad and the board pad is melted, the electrical and physical connection between the electrochemical sensor and the main board can be completed.

Description

{Continuous analyte measurement device and electrochemical sensor Connection Method By Local Heating Portion}

The present invention relates to a continuous analyte measuring device to which a flexible electrochemical sensor is attached and a method of attaching the electrochemical sensor using a local heating unit.

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 main board of the sensor and transmitter, a method of inserting the proximal part into the connector of the main board, a method of integrating the proximal part with the main board with a conductive fixing member (metal rivet, etc.), a method of sandwiching the proximal part into the main board. etc. can 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 of the present invention may include a flexible base layer to relieve pain and reduce foreign body sensation.

The present invention maintains a molten state of the soldering paste by locally heating the proximal sensor pad and substrate pad without causing thermal damage to the base layer of the electrochemical sensor, the proximal sensor pad, the main substrate, and the substrate pad of the main substrate. You can get it.

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 comprising a main board in which at least one of a power supply unit, a communication unit, and a control unit is surface mounted, and a housing in which the main board is stored, where a board pad is formed on the main board and the housing is attached to the skin. ; In a state where the needle and the distal part are inserted into the body together, measurement of the analyte is performed, and after the skin is incised by the needle, the distal part of the electrochemical sensor is inserted into the body, and face each other. When the soldering paste between the sensor pad and the board pad is melted, the electrical and physical connection between the electrochemical sensor and the main board can be completed.

A local heating unit is provided to locally heat a predetermined area of the sensor pad and the substrate pad facing each other, and the local heating unit heats at least one of the sensor pad, the main substrate, the substrate pad, and the soldering paste in a non-contact manner. It can be heated by.

The local heating unit may heat at least one of the sensor pad, main board, substrate pad, and soldering paste using an induced magnetic field generated by a coil.

The local heating unit may include a laser head that irradiates a laser to at least one of the sensor pad, main substrate, substrate pad, and soldering paste.

The base layer or main substrate of the electrochemical sensor includes a transparent material through which the laser passes, and a third through hole through which the laser passing through the base layer passes is formed in the sensor pad. A fourth through hole through which the laser passing through the main substrate passes may be formed.

According to the sensor attachment method of the present invention, a continuous analyte measuring device that continuously measures an analyte in the body includes an electrochemical sensor and a transmitter attached to the skin together with the electrochemical sensor, wherein the electrochemical sensor includes, It includes a distal part formed with a plurality of electrodes that react with analytes in the body, a proximal part formed with a sensor pad connected to the electrodes, and an intermediate part located between the distal part and the proximal part, and the transmitter includes at least one of a power source unit, a communication unit, and a control unit. It includes a main board, one of which is surface mounted and has board pads formed thereon, a housing in which the main board is stored, and applying soldering paste to at least one of the sensor pad and the board pad; Forming a primary joint by compressing the sensor pad and the substrate pad facing each other with the soldering paste therebetween; heating a predetermined area where the electrochemical sensor and the main board where the first junction is formed face each other with a local heater; A soldering step of forming a secondary joint by melting the soldering paste of the primary joint by the local heating unit; It includes, and the electrochemical sensor and the main board can be completely coupled by the secondary junction.

A membrane is applied to the electrochemical sensor, and the local heating unit can heat a predetermined area where the electrochemical sensor and the main substrate face each other in a non-contact manner at a location spaced apart from the membrane.

The electrochemical sensor of the present invention does not come into contact with the human body only momentarily by analyzing body blood, but can remain invasive into the human body along with a needle for a significant period of several days to tens of days. Accordingly, transmitters and electrochemical sensors attached to the skin may have problems with waterproofing in everyday life such as in the shower, and problems with reduced contact due to movement, vibration, shock, etc. of the attachment part of the human body.

While analyzing blood sugar, etc. from the invasive distal electrode, it is important that the electrical connection between the transmitter attached to the skin and the proximal part is maintained. Due to the frequent vibration environment, the electrical contact between the thin and small electrochemical sensor and the main board of the transmitter can easily become separated or have poor contact.

The electrochemical sensor of the present invention has a small thickness and size, and can relieve pain when at least part of the distal part invades the human body and reduce the sensation of a foreign body.

The electrochemical sensor of the present invention may have a thin thickness of tens or hundreds of micrometers or less and may have a small size. When electrically connected to the main board by a physical insertion method such as a connector, the proximal part may be damaged or the rigidity of the proximal part may be weak, making insertion impossible.

If the electrochemical sensor is an enzyme type, the enzyme is thermally destroyed, so soldering by overall heating may be impossible. In the case of enzyme-type sensors, there is a problem with other complex processes such as ZEBRA rubber, which is alternately laminated with elastomer and conductive layers, and ACF, which is impregnated with conductive balls, to replace soldering by overall heating.

Even in the case of non-enzymatic sensors, the size and thickness of the sensor are small, so the problem of having to rely on connection means of a complex structure such as ZEBRA rubber or ACF may still remain.

No attempt has been made so far to connect an electrochemical sensor in the form of FPC, with a PI base layer, or with a PET base layer, to the main board using the SMT method.

The proximal part of the present invention can be firmly electrically connected to the main board by soldering using a local heating unit.

The present invention does not heat the entire sensor, but has a local heating unit that locally heats only the portion where the sensor pad and the substrate pad face each other. Therefore, even if the sensor of the present invention is an enzyme-type sensor, a metallic paste is used during soldering by the local heating unit. It has the advantage of minimizing thermal damage to the formed sensor pattern or membrane.

On the other hand, if the sensor of the present invention is a special non-enzymatic sensor that forms a conductive layer by sputtering metal, there is no need to worry about thermal deformation of the metal pattern forming the conductive layer. Thermal strain is likely to occur in membranes over electrodes containing organic substances, enzymes, or metallic pastes. Therefore, heating only the sensor pad with the local heating unit of the present invention can be a fundamental technology that can solder not only the metal pattern and metallic conductive layer of a non-enzymatic sensor, but also the membrane that has the possibility of thermal deformation without applying any heat stress. there is.

1 is a cross-sectional side view of the inserter and transmitter of the present invention.
Figure 2 is a perspective view of the needle and electrochemical sensor of the present invention.
Figure 3 is a plan view of Figure 2.
Figure 4 is an explanatory diagram of the enzyme-type sensor of the present invention.
Figure 5 is an explanatory diagram of the base layer, conductive layer, and insulating layer of the non-enzymatic sensor of the present invention.
Figure 6 is an explanatory diagram of a trench, which is a pattern of the electrochemical sensor of the non-enzymatic sensor of the present invention.
Figure 7 is a side view and a top view of the electrochemical sensor of the non-enzymatic sensor of the present invention.
Figure 8 is a top view of an array of multiple electrochemical sensors of the present invention.
Figure 9 is an exploded perspective view of one embodiment of the transmitter structure of the present invention.
10 and 11 are explanatory diagrams for soldering according to the present invention.
Figure 12 is a plan view of another embodiment of the proximal portion of the present invention.
Figure 13 is an example of a local heating unit of the present invention and explains non-contact induction heating.
14 and 15 illustrate non-contact laser heating as another example of the local heating unit of the present invention.

Hereinafter, the case where the electrochemical sensor 400 of the present invention is used in a continuous glucose monitoring system (CGMS) that measures interstitial fluid or blood glucose concentration will be described as an example. However, it is not limited to measuring glucose concentration and can be extended to continuous analyte measurement devices that measure other analytes.

<Inserter and transmitter>

Referring to FIG. 1, the electrochemical sensor 400 of the present invention can be attached to the skin together with the transmitter 200. The transmitter 200 may process the analyte signal measured by the electrochemical sensor 400 to generate analyte data and wirelessly transmit the analyte data to an external terminal. External terminals, including mobile devices, can continuously monitor and diagnose analyte data.

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

One end of the electrochemical sensor 400 connected to the main board 202 of the transmitter 200 may be referred to as the proximal part 402, and the other end of the electrochemical sensor 400 that invades the body may be referred to as the distal part 406. You can. The flexibly bent portion between the proximal portion 402 and the distal portion 406 may be referred to as the folded portion 405.

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

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

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

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

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

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

The needle 300 may be fixed to the needle handle 310. The needle handle 310 can be attached to or detached from the driving unit 102. The driving unit 102 may drive the needle handle 310 to move the needle 300.

An internal space may be provided between the upper lid and lower lid of the transmitter 200. The main board 202 may be seated in the internal space of the transmitter 200.

The main board 202 includes a power supply such as a battery required to measure the glucose concentration in the distal part 406, a control unit for processing analyte data, a wireless communication unit for wirelessly transmitting data measured by the electrochemical sensor 400, and analysis. At least one of the operational amplifiers that amplify the water signal may be surface mounted. The current output from the working electrode may have a concentration near the electrode 424. The controller may control the electrical potential between the working electrode and the reference electrode.

The sensor pad 428 formed on one side of the electrochemical sensor 400 may face the main board 202, and the other side of the electrochemical sensor 400 may be exposed to the internal space of the transmitter 200. A substrate pad 612 electrically connected to the sensor pad 428 may be formed on the main substrate 202.

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

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

With the end 104 of the inserter 100 in contact with the skin, the inserter 100 may be fixed on the skin. The inserter 100 corresponds to the fixed part, and the needle 300 or transmitter, which corresponds to the moving part, can be raised and lowered by the driving part 102.

Reduction of pain and foreign body sensation are the core performance of continuous analyte meters from the user's perspective. To this end, the electrochemical sensor 400 has flexibility that makes it impossible to penetrate the skin alone, and the electrochemical sensor 400 is thin and flexible enough to be inserted into the body only when the needle 300 incises the skin.

FIG. 1 may show a first embodiment of a transmitter 200 in which an electrochemical sensor 400 and a needle are coupled to penetrate the transmitter 200.

FIG. 9 may show a second embodiment of the transmitter 200 in which the electrochemical sensor 400 and the needle are coupled to penetrate the transmitter 200.

Referring to FIG. 1, the first embodiment may be a case in which a needle through hole is formed in the upper housing 210 and the lower housing 220 of the transmitter 200. When inserted, the needle sequentially passes through the through hole formed in the upper housing 210 of the transmitter 200 and the through hole formed in the lower housing 220, and when separated, the needle passes through the through hole in the opposite order and transmits the transmitter (200). ) is separated from. The electrochemical sensor 400 is exposed to a through hole to align with the needle.

At this time, an outer sealing member is required at the joint between the upper housing 210 and the lower housing 220 located on the outer periphery of the transmitter 200, and the joint between the upper housing 210 and the lower housing 220 located at the through hole. An inner circumferential sealing member is required, and a sensor sealing member may be needed at a portion where the electrochemical sensor 400 is exposed through the through hole.

Referring to FIG. 9, the second embodiment may be a case where a depression 204 is formed by recessing the side of the transmitter 200. In this case, since the through hole through which the needle passes is eliminated, one outer sealing member is sufficient and an inner sealing member may not be necessary. Additionally, there is no need for a pillar structure of the upper housing 210 and the lower housing 220 to form a central through hole.

If the through hole and the pillar structure at the through hole location of the first embodiment of the transmitter 200 are deleted, the internal space of the transmitter 200 is greatly expanded even if the transmitter 200 has the same diameter. The expanded space can extend the service life and reduce the user's transmitter replacement costs by installing a large capacity battery. On the other hand, it is possible to achieve optimized arrangement of electronic components and design freedom of the main board, which can also contribute to improved performance.

<Needles and electrochemical sensors>

With reference to FIGS. 2 and 3 , the arrangement relationship between the needle 300 and the electrochemical sensor 400 will be described.

An opening 306 may be formed in the needle 300 to expose the inside of the needle 300 to the outside and extend along the longitudinal direction of the needle 300. A portion of the distal portion 406 or folded portion 405 may be attached to or spaced apart from the needle 300 so as to be inside the opening 306 during invasion into the body.

The distal portion 406 and the proximal portion 402 may lie in different planes with a predetermined angle (eg, 90 degrees). The bending direction of the folded portion 405 may coincide with the direction in which the needle 300 is opened by the opening portion 306.

The location where the proximal portion 402 is electrically connected to the transmitter 200 may be located in a direction where the inside of the needle 300 is opened to the outside by the opening portion 306.

For example, the distal portion 406 can be inserted perpendicular to the skin surface to reduce pain and foreign body sensation. When the main substrate 202 is disposed parallel to the bottom surface of the transmitter 200, the proximal portion 402 may be disposed parallel to the main substrate 202, and the proximal portion 402 may be disposed parallel to the skin surface. You can.

The folded portion 405 may be bent along the direction in which the inside of the needle 300 is opened to the outside.

The needle 300 may include a center wall portion 302 that guides the electrochemical sensor 400 and a side wall portion 304 that prevents the electrochemical sensor 400 from being separated from the needle 300.

The central wall portion 302 may prevent the distal portion 406 or the folded portion 405 from protruding in the first axis direction. The first axis direction may be a direction in which the inside of the needle 300 is opened to the outside. If the distal portion 406 or the folded portion 405 protrudes in the first axis direction, the protruding portion may be caught on the skin and the electrochemical sensor 400 may be buckled, and only the needle is inserted into the skin and the electrochemical sensor (400) can bounce off the skin.

The side wall portion 304 may prevent a portion of the distal portion 406 or a portion of the folded portion 405 from being separated in the second axis direction. The second axis direction may be perpendicular to the first axis direction. The first axis direction, the second axis direction, and the insertion direction may each correspond to a Cartesian coordinate system.

The inner space of the needle 300 surrounded by the center wall portion 302 and the side wall portion 304 may be communicated with the outside through the opening portion 306.

The electrochemical sensor 400 may have a flat plate shape. The electrode 424 of the distal portion 406 may be disposed on one or both sides of the flat portion.

A portion extending the middle portion 404 between the distal portion 406 and the proximal portion 402 in the first direction may be the side extension portion 408. The middle portion 404 adjacent to the distal portion 406 is in the same plane as the distal portion 406, and extends the middle portion 404, which is in the same plane as the distal portion 406, in a first direction that is the exposure direction of the needle 300. One portion is the side extension 408.

<Electrochemical sensor>

4 to 8, the electrochemical sensor 400 of the present invention will be described.

Figure 7 may show the structure of the electrochemical sensor 400 of the present invention.

FIG. 7 may be a case where the electrode 424 and the sensor pad 428 are formed on the same surface of the electrochemical sensor 400.

However, the present invention not only applies to the case where the electrode 424 and the sensor pad 428 are formed on one side of the electrochemical sensor 400, but also when the electrode 424 and the sensor pad 428 are formed on both sides of the electrochemical sensor 400. It can be expanded and applied to cases where it is formed.

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

Referring to FIG. 7, a sensor pad 428 connected to the electrode 424 may be formed in the proximal portion 402. The current generated through an electrochemical reaction with glucose in the body in the distal part 406 may be connected to the sensor pad 428 in the proximal part 402 along the lead 426 formed on the base layer 410. The sensor pad 428 may be electrically connected to the main board 202.

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

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

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

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

The length at which the invasive electrochemical sensor 400 is inserted into the skin may range from 3 to 12 mm. If the insertion length is 3 mm or less, the stability of the sensor itself and signal stability may be reduced due to movement of the living body after the sensor is inserted into the living body. If the insertion length exceeds 12 mm, it is located in a range where pain points in the human body are distributed, which can increase pain and damage internal tissues such as blood vessels and nerves.

Additionally, the width of the invaded portion of the distal portion 406 may range from 100 to 600 μm. The thickness of the invaded portion of the distal portion 406 may range from 10 to 300 μm, and preferably may range from 50 to 150 μm.

Since at least a portion of the distal part 406 is inserted into the body, if the width of the distal part 406 is too wide, pain and foreign body sensation may increase during invasion, so there is a need to reduce it to a predetermined width (for example, 600㎛) or less. If all three or more electrodes 424 are placed on only one side of the distal part 406 that invades the body, the width of the distal part 406 is changed to secure space for the three or more electrodes and the leads 426 connected to them in terms of analyte data. should be wide, but may be limited to a certain width (for example, 600㎛) or less in terms of pain relief. Both trade-off relationships must be satisfied.

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

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

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

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

Electrodes and sensor pads may be formed using a laser etching method that removes part of the conductive layer by irradiating a laser to the conductive layer. After the conductive layer is laminated, the edge boundary of the electrode and the edge boundary of the sensor pad may be formed. The leads connecting the electrode and the sensor pad, respectively, may be formed by cutting a portion of the conductive layer in the vertical direction like the electrode and the sensor pad. An insulating layer may be attached after the edge boundaries of the electrodes and the edge boundaries of the sensor pad are formed.

A trench may be engraved into the conductive layer and the conductive island patterned accordingly. The height of the trench may be equal to the thickness of the conductive layer. The thickness of the conductive layer, electrode, and sensor pad may all be the same.

The width of the electrochemical sensor may be 600 micrometers or less, and the length of the electrochemical sensor may be 3 cm or less. The width of the electrode and the width of the sensor pad are 500 micrometers or less, the width of the lead is 150 micrometers or less, and at least two electrodes and at least two leads may be formed on one surface of the distal portion of the electrochemical sensor.

No matter how complex the electrode pattern is or how narrow the trench width is, it can be formed without burrs through laser etching. To simplify the process, it is preferable that the conductive layer is metal sputtered over the entire exposed area of the base layer. When forming a double-sided electrode, both the top and back surfaces of the base layer where the via hole is formed can be sputtered with metal.

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

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

Figure 4 may illustrate an enzyme-type sensor as an embodiment of the present invention. As another embodiment of the electrochemical sensor 400 of the present invention, it can be compared with FIGS. 5 and 6, which illustrate a non-enzymatic sensor.

Figure 4 illustrates the case of forming two electrodes, a first electrode (62a) and a second electrode (64a), of the enzyme-type sensor of the present invention. A first electrode layer 62, a first insulating layer 63, a second electrode layer 64, and a second insulating layer 65 may be laminated in that order on the base layer 61 forming the body of the sensor 100. there is. To form two electrodes, the base layer 61, the first electrode layer 62, the first insulating layer 63, the second electrode layer 64, and the second insulating layer 65 are sequentially used to form electrodes. The length of the part may be formed to be longer. From the difference in length of each layer, the first electrode 62a may be exposed to the first electrode layer 62, and the second electrode 64a may be exposed to the second electrode layer 64.

The first electrode layer 62 and the second electrode layer 64 may be formed by printing a metallic paste on a layer corresponding to an insulating layer or a dielectric layer. The components and structure of the metallic paste may be those used in an enzyme reaction type blood glucose meter.

In the enzyme-type sensor of the present invention, the planes on which the first electrode layer and the second electrode layer are disposed may be different, and the components of the applied metallic paste may vary depending on the type of electrode. In the case of enzyme-type sensors, there is a high risk of damage due to the heat required to melt the soldering paste. If soldering is performed using the overall heating method rather than the local heating of the present invention, there is a problem that not only the metallic paste covered with the insulating layer but also the metallic paste exposed to the outside may be thermally deformed.

The present invention does not heat the entire sensor, but has a local heating unit that locally heats only the portion where the sensor pad and the substrate pad face each other, so even if it is an enzyme-type sensor, the metallic paste is not thermally damaged during soldering by the local heating unit 50. There is an advantage to not having it.

Meanwhile, in the case of the non-enzymatic sensor of the present invention, the conductive layer of the electrochemical sensor is formed with the same metal surface by a method such as metal sputtering, so when reflowed to the local heating unit 450, there is no thermal damage to the conductive layer of the sensor. It has the fundamental advantage of being able to prevent thermal damage to the membrane without causing heat damage.

Referring to FIG. 5, the non-enzymatic electrochemical sensor 400 of the present invention may include a flexible base layer 410 that can be bent when invading the body. The base layer 410 is an insulating material and may include at least one of synthetic resin, polyimide (PI), and polyethylene terephthalate (PET). The thickness of the base layer or insulating layer may be 100 micrometers or less.

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

The electrodes and sensor pads are formed using a laser etching method that removes part of the conductive layer by irradiating a laser to the conductive layer, which can satisfy the trade-off between miniaturization and insulation.

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

After forming the conductive layer 412, the insulating layer 416 may be attached. An insulating layer with a portion of the insulating layer corresponding to the electrode and sensor pad removed may be adhered onto the conductive layer so that the electrode and sensor pad are exposed to the outside.

A portion of the insulating layer 416 may be removed using a cutter or punching machine. When the size of the opening in the insulating layer is small and microprocessing is required, the laser etching method used to form the trench in the conductive layer can be used to process the opening in the insulating layer.

The same goes for the base layer. Since the via holes required for double-sided formation require micro-processing, the laser etching method used to form trenches in the conductive layer can be used to process via holes in the base layer. A via hole is formed by cutting a portion of the base layer, and the conductive layer can be double-sided sputtered with the same metal material to be seamlessly continuous along the top surface of the base layer, the surface of the via hole, and the back surface.

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

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

The electrochemical sensor 400 of the present invention may include a porous selectively transparent layer 418 surrounding the surface of the electrode 424. The membrane may include a selectively transparent layer (418). The membrane may include at least one of organic materials, metal particles, metallic paste, and enzymes. The selectively transparent layer 418 is intended to react with an analyte that reacts in the body and may be applied to the electrode 424 of the distal portion 406.

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

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

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

Figure 6 is a detailed explanation of the trench 420 of the conductive layer 412 of the non-enzymatic sensor.

FIG. 6 may schematically illustrate the entire electrochemical sensor 400 from the proximal portion 402 to the distal portion 406.

Referring to FIG. 6, after the conductive layer 412 is deposited on the base layer 410 by a method such as sputtering, a trench 420 may be formed by a method such as laser etching.

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

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

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

The conductive island can be divided into a conductive island in which the part corresponding to the electrode and sensor pad is exposed to the outside through a cut part of the insulating layer, and a dummy part in which the entire part is covered with an insulating layer so that no part 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 in the proximal portion 402, a first lead 426a in the folded portion 405, and a first electrode 424a in the distal portion 406. .

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

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

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

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

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

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

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

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

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

Figure 8 shows a sensor array for manufacturing a plurality of electrochemical sensors 400 at once. To repeatedly form the selective transmission layer, at least one of dip coating, spray coating, and paste methods may be performed.

Referring to FIG. 8, an alignment hole 72 is formed in the base layer 410, and the alignment hole 72 can be inserted into the alignment pin of the jig. The alignment hole 72 of the base layer 410 and the alignment hole (not shown) of the insulating layer 416 are aligned with each other, and thus the opening of the insulating layer 416 can be aligned with the electrode or sensor pad. there is.

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

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

<Attachment of electrochemical sensor>

10 to 15, soldering attachment between the electrochemical sensor 400 and the main board 202 of the present invention will be described.

The electrochemical sensor 400 has a small thickness and size, and can relieve pain when at least a portion of the distal part 406 invades the human body and reduce the sensation of a foreign body.

The electrochemical sensor 400 may have a thin thickness of tens or hundreds of micrometers or less, and due to its small size, it may be difficult to be firmly fixed and connected to the main board 202 by a physical insertion method such as inserting a connector. .

To solve this problem, only the soldering paste position of the proximal part 402 of the present invention is heated by the local heating part 450 while facing the main board 202 on which component mounting is completed, thereby preventing damage to the electrochemical sensor 400. It can be connected electrically without any heat damage.

10 and 11 show the sensor pad 428 of the proximal portion 402 and the substrate pad 203 of the main substrate 202 facing each other, and soldering paste between the sensor pad 428 and the substrate pad 203. With (440) positioned, soldering may be in progress.

Figure 10 shows the electrochemical sensor 400 and the main board 202 spaced apart from each other before soldering, and Figure 11 shows the electrochemical sensor 400 in contact with the main board 202 during or after soldering. It may indicate a state.

Referring to FIGS. 10 and 11 , a sensor manufacturing process may be performed simultaneously in an array in which a plurality of electrochemical sensors 400 are repeatedly arranged, and then the electrochemical sensors 400 may be separated from each other. The proximal portion 402 of the separated electrochemical sensor 400 may be attached to the main board 202 by soldering using soldering paste 440.

For soldering by the local heating unit 450 of the present invention, the melting temperature of the soldering paste 440 is the conductive layer 412, the base layer 410, and the electrochemical sensor 400 forming the sensor pad 428. ) may be set lower than the melting temperature of the membrane attached to the membrane, the selective transmission layer 418, the substrate pad 203, and the components surface mounted on the main substrate 202.

The electrochemical sensor 400 may be manufactured in a plurality of arrays and then separated individually. Before the individually separated electrochemical sensors 400 are attached to the main board 202 of the transmitter 200, all processes applied to the electrochemical sensors 400 may have been performed. Accordingly, all processes related to the electrochemical sensor 400 can be completed by simply attaching the electrochemical sensors 400 individually separated from the array to the main board 202 by soldering.

When soldering by the local heating unit 450, a dispenser that can move in three-dimensional space coordinates is predetermined on at least one of the sensor pad 428 of the electrochemical sensor 400 and the substrate pad 203 of the main board 202. Soldering paste 440 can be applied to precise, minute positions. The fine position is the position of the sensor pad 428 or the position of the substrate pad 203.

A primary joint may be formed by pressing the sensor pad 428 and the substrate pad 203 that face each other with the soldering paste 440 in between. The flow of the electrochemical sensor 400 and the main board 202 is suppressed by the primary joint and can be input into the local heating unit 450.

The main board 202 may have other components mounted on its surface before being put into the local heating unit 450.

The membrane applied to the electrode 424 in the distal portion 406 may include an optional transparent layer 418. By using the local heating unit 450 of the present invention, heat may not be applied to the membrane regardless of whether the electrochemical sensor 400 is enzymatic or non-enzymatic.

Accordingly, the selective transmission layer 418 may contain any number of analyte-reactive enzymes with high temperature deformability. This is because heat conduction of the electrochemical sensor 400 or the membrane by the local heating unit 450 is minimized.

When an enzyme is included in the membrane of the present invention, the soldering temperature or reflow temperature of the local heating part may be set to a temperature at which the effectiveness of the enzyme of the membrane is destroyed.

The local heating unit 450 may locally heat the electrochemical sensor 400 and the main substrate 202 that are temporarily joined by the primary joint. Only the soldering paste 440 of the primary joint can be melted without heat conduction to other components attached to the main board 202 or to the membrane attached to the electrochemical sensor 400. The soldering paste 440 melted in the local heating unit 450 forms a secondary joint, and the electrochemical sensor 400 and the main board 202 can be completely coupled by the secondary joint.

The soldering paste 440 may be applied to the sensor pad 428 or the substrate pad 203 by dispensing or mask etching. When both the selectively transparent layer 418 and the soldering paste 440 are applied by dispensing, the process time can be shortened.

A local heating unit 450 may be provided that heats only the part where the sensor pad 428 and the substrate pad 203 face each other in a non-contact manner among all parts of the sensor.

The local heating unit 450 may heat at least one of the sensor pad 428, the substrate pad 203, and the soldering paste 440 using a non-contact method.

When soldering between the sensor pad 428 and the substrate pad 203, the local heating unit 450 increases the temperature of the base layer 410 or the main substrate 202 excluding the sensor pad 428 and the substrate pad 203. Rise can be minimized. Only the soldering paste 440 can be melted by the laser irradiated to a specific area.

The melting temperature of the soldering paste 440 is lower than the melting temperature of at least one of the conductive layer 412, the base layer 410, the substrate pad 203, and the main substrate 202 forming the sensor pad 428. It is desirable.

By the local heating unit 450, the base layer 410 can be heated to a first temperature, the sensor pad 428 can be heated to a second temperature, and the main substrate 202 can be heated to a third temperature. may be, and the substrate pad 203 may be heated to the fourth temperature.

At this time, the melting temperature of the soldering paste may be set to be lower than the first to fourth temperatures. This temperature setting can prevent heat transferred from the molten soldering paste from causing thermal damage to surrounding components.

The melting temperature of the soldering paste 440 may be set in the range of 20 degrees to 300 degrees.

The base layer 410 may include polyimide (PI) or PET. By melting only the soldering paste 440 without causing thermal damage to the base layer 410, the sensor pad 428 and the substrate pad 203 can be soldered.

Additionally, the melting temperature of the soldering paste 440 may be lower than the temperature that causes defects in the pattern 420 of the electrochemical sensor 400 connected to the sensor pad 428, and the temperature of the electrical circuit of the main board 202 It may be lower than the temperature that causes defects.

Since the local heating unit 450 is installed, the heat generated during soldering decreases as the distance from the sensor pad 428 increases and may not affect other parts of the pattern 420 of the electrochemical sensor, and the heat generated during soldering may not affect other parts of the pattern 420 of the electrochemical sensor. ), it decreases as you move away from it, so it may not have any effect, such as defects, on other parts of the electric circuit.

The temperature that causes defects in the pattern 420 of the electrochemical sensor 400 may be the temperature that causes defects in the pattern 420 of the electrochemical sensor 400 even though the heat generated during soldering gradually decreases. . The temperature that causes a defect in the electric circuit on the main board 202 may be a temperature that causes a defect in the electric circuit in the main board 202 even though the heat generated during soldering gradually decreases.

The electrochemical sensor 400 soldered to the main board 202 may be individually separated and inserted in an array state after the sensor manufacturing process has been performed. That is, the electrochemical sensor 400 separated from the array may be in a state in which all processes applied to the electrochemical sensor 400, in addition to being attached to the main substrate 202, have been performed.

Before soldering the electrochemical sensor 400, all processes necessary for manufacturing the electrochemical sensor 400 may have been completed. When the electrochemical sensors 400 individually separated from the array are soldered and attached to the main board 202, the process may be completed without additional processing before invasion into the body.

The sensor manufacturing process in which a plurality of electrochemical sensors 400 are performed in an array form includes a conductive layer step of stacking a conductive layer 412 on the flexible base layer 410 of the electrochemical sensor 400, a distal portion 406 When a double-sided electrode is formed, a via-hole step in which a via-hole penetrating the base layer 410 is formed, an insulating layer step in which the insulating layer 416 is attached to the conductive layer 412, and a conductive layer 412 ), a trench step of forming the trench 420, which is the pattern of the electrochemical sensor 400, a heat treatment step performed after the conductive layer step or the insulating layer step as needed, and dispensing into the opening 422 of the insulating layer 416. At least one of the membrane steps of applying the selectively transparent layer 418 may be included, or the like.

The main board 202 may have other components 203a and 203b already installed before soldering. Other components may include a control unit including a signal amplifier, an operation unit, a storage unit, etc., a communication unit including a Bluetooth chip and an antenna, and other resistors, condensers, etc.

Because soldering is performed locally near the proximal portion 402, the distal portion 406 can be protected from the heat of soldering. Therefore, in the electrochemical sensor 400 of the present invention, the selective transmission layer 418 applied to the electrode 424 of the distal portion 406 includes an enzymatic blood glucose group containing a temperature-sensitive analyte-reactive enzyme, and a non-enzymatic blood glucose group. It can be used on all blood sugar monitors.

Figure 12 shows an embodiment of the electrochemical sensor 400. When attached using the soldering method of the present invention, the arrangement of the proximal part 402 may not be affected by the shape or coupling conditions of ZEBRA or ACF, which are connection means. . Accordingly, the proximal portion 402 can have various shapes and the shape of the proximal portion 402 can be freely designed.

The reason is explained as follows. Since the proximal portion 402 is electrically connected to the main board 202, restrictions may be placed on its structure and design. For example, when the sensor pad 428 of the proximal portion 402 is inserted into the connector through a physical method such as sandwiching, the shape of the proximal portion 402 may be restricted depending on the structure of the connector into which it is inserted or sandwiched. There may be a limitation that the sensor pad 428 must belong to one plane.

In addition, when the electrochemical sensor 400 and the main board 202 are attached by a straight type connection means such as a conductive patch containing ZEBRA or ACF or a compressive tape, restrictions will be placed on the arrangement of the sensor pad 428. You can.

However, when soldered according to the present invention, the planes where the sensor pad 428 and the main board 202 meet can be formed differently, and the attachment height or location can be free depending on the three-dimensional shape of the board pad 203.

Figure 13 shows an example of non-contact soldering of the present invention, in which the local heating unit 450 performs soldering by an induced magnetic field generated by a coil.

Referring to FIG. 13, the local heating unit 450 uses the induced magnetic field generated by the coil 464 to heat at least one of the sensor pad 428, the substrate pad 203, and the soldering paste 440. It can be heated. The soldering paste 440 may contain a magnetic material so that it can be heated by an induced magnetic field generated by the coil 464.

The local heating unit 450 includes a coil 464 that generates an induced magnetic field, a magnetic material 466 that guides the shape or direction of the magnetic field generated by the coil 464, and a coil 464 and a magnetic material 466. It may include at least one of the moving head 460 and a moving means 462 that moves the moving head 460 along the three axes of the x-axis, y-axis, and z-axis.

According to the local heating unit 450, only the soldering portion can be locally heated at room temperature, and the soldering process can be confirmed with the naked eye or a camera from the surrounding area. Soldering may be possible immediately after dispensing and chip mounting, and practical 3D soldering may be possible.

Soldering time can be shortened compared to the soldering method in which the sensor and main board are placed in a chamber and the entire thing is reflowed. The equipment installation space of the local heating unit 450 may be very small. Soldering of the main board and sensor may be possible even when plastic parts with low heat resistance are mounted on the main board, allowing a wide selection of electrical components to be mounted on the main board.

Since the heat for melting the soldering paste is transmitted locally, thermal damage to the main board, electrochemical sensor, and electrical components mounted on the main board can be minimized. Since the soldering paste melts by applying only a small amount of heat that can be touched immediately after soldering, a separate cooling process may not be necessary. Local heating 450 may have very low power consumption. There may be fewer soldering voids. Soldering may be possible even with plating containing Ni and having poor solder wettability.

14 and 15 show another example of non-contact soldering of the present invention, in which the local heating unit 450 performs soldering by laser irradiation.

The local heating unit 450 may include a laser head 490 that irradiates a laser to at least one of the sensor pad 428, the soldering paste 440, and the substrate pad 203.

The melting temperature of the soldering paste 440 may be lower than the melting temperature of the sensor pad 428 and the substrate pad 203.

When the base layer 410 and the sensor pad 428 have low light transparency, a first through hole 471 through which the laser passes may be formed in the base layer 410 and the sensor pad 428.

When the main substrate 410 and the substrate pad 428 have low light transparency, a second through hole 472 through which the laser passes may be formed in the main substrate 410 and the substrate pad 428.

If the base layer 410 of the electrochemical sensor 400 is opaque or is made of a material with low laser transparency, the laser may be reflected from the base layer 410 before reaching the soldering paste 440. The sensor pad 428, which is a metal thin film formed by sputtering, can reflect a laser.

Therefore, if the base layer 410 or the sensor pad 428 is a light-reflective material or a material with low laser transparency, the laser can reach the soldering paste 440 without being blocked by the first through-hole 471. there is.

The second through hole 472 can also be described in the same way as the first through hole 471.

Meanwhile, a third through hole 473 through which the laser that has passed through the base layer 410 passes may be formed in the sensor pad 428. Alternatively, a fourth through hole 474 may be formed in the substrate pad 203 through which the laser that has passed through the main substrate 202 passes.

If the base layer 410 of the electrochemical sensor 400 is a transparent material or a material with high laser transparency, and the conductive layer 412 formed by metal sputtering is a metal with low laser transparency such as gold, the laser is applied to the soldering paste ( It may reflect off the sensor pad 428 before reaching 440).

Therefore, when the base layer 410 is a transparent material or a material with high laser transparency, and the conductive layer 412, sensor pad 428, and substrate pad 203 are metal with low laser transparency, the third through hole 473 ), the laser can reach the soldering paste 440 without being blocked.

The fourth through hole 474 can also be described in the same way as the third through hole 473.

61... base layer 62... first electrode layer
62a... first electrode 63... first insulating layer
64... second electrode layer 64a... second electrode
65... second insulating layer 70... mask
72... alignment hole 100... inserter
102... drive unit 200... transmitter
202... main board 203... board pad
204... depression 230... electrical component
230a... first electrical component 230b... second electrical component
300...needle
302... center wall portion 304... side wall portion
306... opening 310... needle handle
400... electrochemical sensor 402... proximal
404... middle part 405... folded part
406... distal part 408... lateral extension
410... base layer 412... conductive layer
414...bonding layer 416...insulating layer
418... selectively transparent layer 418a... first selectively transparent layer
481b... second selectively transparent layer 420... trench
420a... electrode trench 420b... edge trench
422... opening 422a... proximal opening
422b... distal opening 424... electrode
424a... first electrode 424b... second electrode
424c... third electrode 426... lead
426a... first lead 426b... second lead
426c... third lead 428... sensor pad
428a... first sensor pad 428b... second sensor pad
428c... third sensor pad 430... conductive island
430a... first conductive island 430b... second conductive island
430c... third conductive island 432... dummy portion
432a... first dummy portion 432b... second dummy portion
440... Soldering paste 450... Local heating section
460... moving head 462... means of transportation
464... coil 466... magnetic material
470... through hole 471... first through hole
472... 2nd through hole 473... 3rd through hole
474... Fourth through hole 490... Laser head
W1,W2... Trench width

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 comprising a main board in which at least one of a power supply unit, a communication unit, and a control unit is surface mounted, and a housing in which the main board is stored, where a board pad is formed on the main board and the housing is attached to the skin. ; Including,
With the needle and the distal part inserted into the body together, a measurement of the analyte is performed,
After the skin is incised by the needle, the distal portion of the electrochemical sensor is inserted into the body,
A continuous analyte measuring device in which the electrical and physical connection between the electrochemical sensor and the main board is completed when the soldering paste between the sensor pad and the substrate pad facing each other is melted.
According to claim 1,
The electrochemical sensor is a continuous analyte measuring device that is at least one of an enzymatic sensor, a non-enzymatic sensor, and a sensor having a membrane formed on the electrode.
According to claim 1,
The electrochemical sensors are separated from each other into individual electrochemical sensors in an array form in which a plurality of electrochemical sensors are repeatedly arranged,
A continuous analyte measuring device in which the proximal portion of the separated electrochemical sensor is attached to each main board by soldering using soldering paste.
According to claim 1,
A local heating unit is provided to locally heat a predetermined area of the sensor pad and the substrate pad facing each other,
The local heating unit is a continuous analyte measuring device that heats at least one of the sensor pad, main substrate, substrate pad, and soldering paste by a non-contact method.
According to claim 1,
A local heating unit is provided to locally heat a predetermined area of the sensor pad and the substrate pad facing each other,
By the local heating unit, the base layer of the electrochemical sensor is heated to a first temperature, the sensor pad is heated to a second temperature, the main substrate is heated to a third temperature, and the substrate pad is heated to a fourth temperature. heated to a temperature,
The melting temperature of the soldering paste is lower than the first to fourth temperatures.
According to claim 1,
A local heating unit is provided to locally heat a predetermined area of the sensor pad and the substrate pad facing each other,
The local heating unit is a continuous analyte measuring device that heats at least one of the sensor pad, main board, substrate pad, and soldering paste using an induced magnetic field generated by a coil.
According to claim 1,
A continuous analyte measuring device in which the soldering paste contains a magnetic material heated by an induced magnetic field of a local heating unit.
According to claim 1,
A local heating unit is provided to locally heat a predetermined area of the sensor pad and the substrate pad facing each other,
The local heating unit is a continuous type that includes at least one of a coil that generates an induced magnetic field, a magnetic material that guides the magnetic field generated by the coil, a moving head in which the coil and the magnetic material are built, and a moving means for moving the moving head. Analyte meter.
According to claim 1,
A local heating unit is provided to locally heat a predetermined area of the sensor pad and the substrate pad facing each other,
The local heating unit is a continuous analyte measuring device including a laser head that irradiates a laser to at least one of the sensor pad, main substrate, substrate pad, and soldering paste.
According to claim 1,
A laser head is provided to irradiate a laser to a predetermined area of the sensor pad and the substrate pad that face each other,
The melting temperature of the soldering paste is lower than the melting temperature of the sensor pad and the substrate pad.
According to claim 1,
A laser head is provided to irradiate a laser to a predetermined area of the sensor pad and the substrate pad that face each other,
A continuous analyte measuring device in which a through hole through which the laser penetrates is formed in at least one of the base layer, sensor pad, main substrate, and substrate pad of the electrochemical sensor.
According to claim 1,
A laser head is provided to irradiate a laser to a predetermined area of the sensor pad and the substrate pad that face each other,
The base layer or main substrate of the electrochemical sensor includes a transparent material through which the laser passes,
A continuous analyte measuring device in which a third through hole through which the laser passing through the base layer passes is formed in the sensor pad, or a fourth through hole through which the laser passing through the main substrate passes through is formed on the substrate pad. .
According to claim 1,
A local heating unit is provided to locally heat a predetermined area of the sensor pad and the substrate pad facing each other,
The electrochemical sensor is a continuous analyte measuring device in which all processes necessary for manufacturing the electrochemical sensor have been completed before soldering by the local heating unit.
A continuous analyte meter that continuously measures analytes in the body includes an electrochemical sensor and a transmitter attached to the skin together with the electrochemical sensor,
The electrochemical sensor includes a distal part formed with a plurality of electrodes that react with analytes in the body, a proximal part formed with a sensor pad connected to the electrodes, and an intermediate part located between the distal part and the proximal part,
The transmitter includes a main board on which at least one of a power supply unit, a communication unit, and a control unit is surface mounted and a board pad is formed, and a housing in which the main board is stored,
Applying soldering paste to at least one of the sensor pad and the substrate pad;
Forming a primary joint by compressing the sensor pad and the substrate pad facing each other with the soldering paste therebetween;
heating a predetermined area where the electrochemical sensor and the main board where the first junction is formed face each other with a local heater;
A soldering step of forming a secondary joint by melting the soldering paste of the primary joint by the local heating unit; Includes,
A sensor attachment method in which the electrochemical sensor and the main board are completely coupled by the secondary junction.
According to claim 14,
A membrane is applied to the electrochemical sensor,
A sensor attachment method in which the local heating unit non-contactly heats a predetermined area where the electrochemical sensor and the main substrate face each other at a location spaced apart from the membrane.
According to claim 14,
A sensor attachment method in which the main board faces the local heating unit with electrical components including at least one of the power unit, communication unit, and control unit surface mounted.

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