KR20250134791A - Continuous analyte measuring device equipped with an electrical connection structure using conductive adhesive - Google Patents

Abstract

The continuous analyte measuring device of the present invention comprises an electrochemical sensor including a distal portion having a plurality of electrodes formed thereon that react with an analyte in the body and a proximal portion having sensor pads formed thereon that are connected to the electrodes; a main substrate having at least one of a power supply unit, a communication unit, and a control unit formed thereon; a housing in which the main substrate is housed therein, wherein contact pads electrically connected to the sensor pads are formed on the main substrate, and the housing is attached to the skin; a transmitter; wherein an electrical connection structure is formed between the sensor pads and the contact pads, and the electrical connection structure includes a through-hole or a conductive adhesive, and the conductive adhesive mutually fixes and conducts the sensor pads and the contact pads, and the through-hole is injected with the conductive adhesive, and the through-hole can be formed in the electrochemical sensor.

Description

Continuous analyte measuring device equipped with an electrical connection structure using conductive adhesive

The present invention relates to a continuous analyte measuring device having an electrical connection structure in which a transmitter including an electrochemical sensor and a main board, etc. are electrically connected using a conductive adhesive or through-hole.

Continuous analyte meters require that at least part of the electrochemical sensor be implanted within the body, and the transmitter, which communicates with the electrochemical sensor and exchanges power or electrical signals, remain attached to the skin for a significant period of time. For these continuous analyte meters, the electrical connection between the electrochemical sensor and the transmitter is crucial: the electrical connection structure and maintenance between the sensor pads of the electrochemical sensor and the contact pads of the transmitter.

According to (a) of Fig. 1, the electrical connection structure between the existing sensor pad (428) and the contact pad (203) includes a method such as an anisotropic adhesive means (ACF etc.) (11), a pasting means (13) using soldering or ultrasonic welding, an intermediate bridge (FPCB etc.) (15) provided between the sensor pad (428) and the contact pad (203), or a connector (17) that electrically connects the sensor pad (428) and the contact pad (203) by physically inserting or otherwise making fixed contact with the main board (202) such as an electrochemical sensor or intermediate bridge (FPCB) (15).

Anisotropic adhesive means (ACF, etc.) (11) has conductive particles (11a) distributed at a predetermined density inside a non-conductive member (11b), and when pressure is applied in a specific direction such as the thickness direction, conductivity is generated only in that direction and there is no conductivity in the longitudinal direction perpendicular thereto, so it has anisotropic conductive properties, and a high temperature process may be accompanied.

The pasting means (13) using soldering or ultrasonic welding requires a heating means or heating process capable of heating to a high temperature while positioning an attachment means such as soldering paste between the sensor pad (428) and the contact pad (203). At this time, the process may become complicated because it is necessary to determine at which stage during the connection process of the sensor (400) to the transmitter (200) the heating will be performed and which part to expose to the heating means depending on the type of electrochemical sensor (400).

In this way, since the existing electrical connection structure using the ACF method (11) or the soldering method (13) requires a process of exposing the transmitter (200) or the electrochemical sensor (400) to a high-pressure/high-temperature environment, there is a difficulty in having a transmitter (200) or sensor (400) that is stably maintained even when exposed to a high-temperature/high-pressure environment, and it may occur that the material or structure of the electrochemical sensor (400) or the transmitter (200) is judged to have high high-temperature durability.

In addition, existing methods such as the FPCB method (15), the connector method (17), and a method combining them may complicate the internal structure of the transmitter (200) or increase its weight. Since the continuous analyte measuring device requires that a part of the electrochemical sensor (400) be inserted into a human body part such as the stomach or arm and that the transmitter (200) be attached to the skin for a considerable period of time for operation, simplifying the internal structure of the transmitter (200) ultimately leads to a reduction in the thickness or size of the transmitter (200), and along with this, the reduction in the weight of the continuous analyte measuring device can reduce the discomfort felt by a person.

The present invention provides a through-hole provided in a main substrate of a transmitter or an electrochemical sensor to electrically connect an electrochemical sensor and a transmitter using a conductive adhesive, and by injecting a conductive adhesive through the through-hole and curing it, the transmitter including the electrochemical sensor and the main substrate are electrically connected, so that power can be supplied or an electrical signal can be transmitted to each other.

The continuous analyte measuring device of the present invention comprises an electrochemical sensor including a distal portion having a plurality of electrodes formed thereon that react with an analyte in the body and a proximal portion having sensor pads formed thereon that are connected to the electrodes; a main substrate having at least one of a power supply unit, a communication unit, and a control unit formed thereon; a housing in which the main substrate is housed therein, wherein contact pads electrically connected to the sensor pads are formed on the main substrate, and the housing is attached to the skin; a transmitter; wherein an electrical connection structure is formed between the sensor pads and the contact pads, and the electrical connection structure includes a through-hole or a conductive adhesive, and the conductive adhesive mutually fixes and conducts the sensor pads and the contact pads, and the through-hole is injected with the conductive adhesive, and the through-hole can be formed in the electrochemical sensor.

The through-hole of the present invention can be precisely formed in the main substrate of an electrochemical sensor or transmitter using a laser or the like, and the present invention can have an electrical connection structure that conducts between the contact pad of the main substrate and the sensor pad of the electrochemical sensor by injecting a conductive adhesive into the through-hole based on this through-hole formation technology. Therefore, the electrical connection structure of the present invention can be based on the through-hole and the conductive adhesive.

Conventional structures for electrically connecting sensor pads and contact pads include anisotropic adhesive means (ACF, etc.), pasting means using soldering or ultrasonic welding, an intermediate bridge (FPCB, etc.) provided between the sensor pad of an electrochemical sensor and the contact pad of a main board, or a connector that electrically connects the sensor pad and the contact pad by physically inserting the electrochemical sensor or the intermediate bridge (FPCB) into the main board and making fixed contact therewith.

As such, existing electrical connection structures using ACF or soldering require exposing the transmitter or electrochemical sensor to a high-pressure or high-temperature environment, and therefore present a challenge in having a transmitter or sensor that remains stable even when exposed to a high-temperature/high-pressure environment.

Furthermore, existing methods, such as FPCB or connectors, can complicate the internal structure of the transmitter or increase its weight. Since continuous analyte measuring devices require the electrochemical sensor to be inserted into a human body part, such as the abdomen or arm, and the transmitter to remain attached to the skin for a significant period of time, simplifying the internal structure of the transmitter is a critical issue, ultimately leading to a reduction in the transmitter's thickness and size. The resulting weight reduction is also crucial for reducing discomfort experienced by the user.

In this way, the present invention does not require a highly durable structure that can withstand high temperature/high pressure environments for the existing ACF or soldering method when connecting the sensor pad and the contact pad, and does not require a hardware structure other than the electrochemical sensor and the main substrate, unlike the existing FPCB or connector, to form a through hole in the electrochemical sensor or the main substrate, which is essential for a continuous analyte measuring device, and to inject and cure a conductive adhesive. Therefore, compared to the existing FPCB or connector method, the internal structure of the transmitter can be simplified, and the thickness and size of the transmitter can be reduced, resulting in an advantage of significantly reducing discomfort caused by insertion or attachment to the human body.

Fig. 1 (a) is a diagram illustrating an electrical connection structure between a conventional sensor pad and a contact pad, and Fig. 1 (b) is a diagram illustrating an electrical connection structure between a sensor pad and a contact pad of the present invention, and the electrical connection structure of the present invention may include a through-hole or a conductive adhesive.
Figure 2 is an embodiment in which the electrochemical sensor and main substrate of the present invention are mounted inside a transmitter.
Figure 3 is an explanatory diagram of the electrical connection structure of Figure 2.
Figure 4 is another embodiment in which the electrochemical sensor and main board of the present invention are mounted inside a transmitter.
Figure 5 is an explanatory diagram of the electrical connection structure of Figure 4.
Figure 6 is a cross-sectional illustration of a continuous analysis material measuring device of the present invention.
Fig. 7 is an embodiment of a transmitter of the present invention, in which a recessed portion may be formed in the transmitter or main board.
Figure 8 is a diagram illustrating the electrical circuit structure of an electrochemical sensor, such as an electrode, a lead, and a sensor pad, by introducing a conductive island of the present invention.
Figure 9 is a manufacturing flow chart of the electrochemical sensor of the present invention.
Figure 10 is a cross-sectional side view of an electrochemical sensor provided with a through-hole or via-hole of the present invention.
Figure 11 is an explanatory drawing of a through hole or via hole of the present invention.

Using FIGS. 1 to 11, the continuous analysis material measuring device of the present invention is described.

In FIGS. 1 to 5, an electrical connection structure for transmitting an electrical signal by conducting between a sensor pad (428) and a contact pad (203) of the present invention is described, and in FIGS. 6 to 11, an overall structure of a continuous analyte measuring device including an inserter (100), a transmitter (200), a needle (300), an electrochemical sensor (400), etc. of the present invention and a specific structure of the electrochemical sensor (400) are described.

<Connecting the electrochemical sensor and transmitter>

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

In (b) of FIG. 1, the present invention relates to an electrical connection structure between a sensor pad (428) of a sensor (400) and a contact pad (203) of a main board (202) (or a transmitter (200)). For convenience of explanation in this specification, the electrical connection structure between the sensor pad (428) and the contact pad (203) is mainly described, but the description of the electrical connection structure between the sensor pad (428) and the contact pad (203) can be expanded depending on the structure of the transmitter (200), the structure of the transmitter (200) to which the sensor (400) is attached, etc.

For example, the structure of most current continuous analysis meters includes a main board (202) built into the transmitter (200), and the main board (202) includes major components such as a power supply unit, a control unit, a wireless communication unit, and an operational amplifier. Therefore, if the contact pad (203), which is an electrical connection end of the main board (202), and the sensor pad (428), which is an electrical connection end of the sensor (400), are interconnected, the electrical connection structure between the sensor (400) and the transmitter (200) can be considered complete.

On the other hand, if the electrical connection end to which the sensor pad (428) is connected is changed, such as when some components included in the main board (202) are formed in the transmitter (200) with a different structure or shape, in which case the object to which the sensor pad (428) is connected may not be the contact pad (203) of the main board (202) described herein, but even in this case, if the electrical connection structure between the sensor (400) and the transmitter (200) is completed by connecting the proximal part (402) of the sensor (400) to the electrical connection end, the contents discussed in the present invention may be extended and applied as is.

The through-hole (1100) into which the conductive adhesive (1300) is to be injected can be classified as a through-hole (1110) of the main substrate (202) or a through-hole (1130) of the electrochemical sensor (400). The case where the through-hole (1110) is provided in the former main substrate (202) can be referred to as a first embodiment of the through-hole (1100), and the case where the through-hole (1130) is provided in the latter electrochemical sensor (400) can be referred to as a second embodiment of the through-hole (1100). FIGS. 2 and 3 relate to the first embodiment, and FIGS. 4 and 5 relate to the second embodiment.

An electrical connection structure (1000, 2000) is formed between a sensor pad (428) and a contact pad (203), and the electrical connection structure may include a through-hole (1100), a conductive adhesive (1300, 2300), a sensor pad (428), a contact pad (203), etc. The conductive adhesive (1300, 2300) can mutually fix the sensor pad (428) and the contact pad (203) to each other and make them conductive, and the conductive adhesive (1300, 2300) can be injected into the through-hole (1100).

According to FIGS. 2 and 3, a first embodiment of an electrical connection structure (1000) between a main board (202) and a sensor (400) is described.

In the first embodiment, the main substrate (202) is placed on top of the sensor (400), and a through hole (1110) may be provided in the main substrate (202). In the second embodiment, the sensor (400) is placed on top of the main substrate (202), and a through hole (1130) may be provided in the sensors (400, 402).

In each case, when the position of the main board (202) or sensor (400) is fixed, a conductive adhesive (1300) can be injected into the through hole (1110, 1130).

The conductive adhesive (1300) may be a room temperature curing type that can be cured by leaving it at room temperature for a considerable period of time without high temperature heating, or a type that can be cured within a short period of time by applying heat by a heating means. In the former case, there is no need for a separate heating means, and the transmitter (200) or sensor (400) may not be exposed to a high temperature environment. In the latter case, since the conductive adhesive (1300) takes a short time to cure, the tact time of the attached product between the sensor (400) and the transmitter (200) is reduced, and the continuous analysis product completion time and manufacturing efficiency can be increased.

In one embodiment of a room-temperature curing conductive adhesive, a curing time of about 24 hours may be required at room temperature (25 degrees Celsius), and the curing time may be longer as the coating thickness of the conductive adhesive (1300) increases. In one embodiment of a high-temperature curing conductive adhesive (1300), a curing time of about one hour may be required at about 60 degrees Celsius.

Continuous glucose monitoring systems (CGMS) can be categorized into enzymatic systems that measure blood glucose using enzymes such as oxidizing enzymes, and non-enzymatic systems that measure blood glucose using electrical signals generated by a reaction with a specific substance applied to an electrode (424) of a distal portion (406). Enzymatic CGMS are vulnerable to high temperatures, and thus may be limited in their use of room-temperature curing conductive adhesives. On the other hand, non-enzymatic CGMS have the advantage of being able to freely use the high-temperature heating step in the manufacturing process of continuous analyte measuring devices, and thus, high-temperature heat-curing conductive adhesives can also be used.

The electrochemical sensor (400) of the present invention, which will be described later, is based on a non-enzymatic method, and therefore has the process freedom to select not only a room temperature curable conductive adhesive but also a high temperature heat-curable conductive adhesive for improving process speed.

Since the main board (202) includes a power supply unit including a battery required for measuring the glucose concentration of the distal portion (406), a control unit, a wireless communication unit that controls data measured by the electrochemical sensor (400) and wirelessly transmits and receives data with the outside, or an operational amplifier, and most of the components responsible for the main functions of the continuous analyte measuring device are included, simplifying the structure of the main board (202) or the connection to the sensor (400) to reduce the thickness or size of the main board (202) can ultimately lead to a reduction in the overall size of the transmitter (200).

In the case where a separate connector structure is used to electrically connect the contact pad (203) of the main board (202) and the sensor pad (428) of the proximal portion (402), a structure for supporting the connector is often added in addition to the connector itself. In addition, since two connections must be maintained, one between the contact pad (203) and the connector and one between the sensor pad (428) and the connector, the possibility of defects due to poor contact, etc., increases compared to the case where a single connection between the sensor pad (428) and the contact pad (203) is maintained.

Meanwhile, it is possible to create a structure that can be connected to the sensor pad (428) on the main board (202) or the contact pad (203) itself without adding a separate connector, but even in this case, a structure in which a structure such as the sensor pad (428) is inserted or otherwise fixed near the main board (202) or the contact pad (203) is required, so, as in the case of introducing a connector, this can be a factor that increases the size of the main board (202).

In contrast, in the case of the present invention, the sensor pad (428) and the contact pad (203) are directly electrically connected with a conductive adhesive (1300), and in particular, rather than simply placing the conductive adhesive (1300) between the sensor pad (428) and the contact pad (203) and joining them together, the conductive adhesive (1300) is injected into the through hole (1100) of the main substrate (202) or the sensor (400) to maintain a stronger connection between the sensor pad (428) and the contact pad (203).

When a conductive adhesive (1300) is injected into the through-hole (1100) while the proximal portion (402) and the main substrate (202) are facing each other or fixed to each other, a central pillar of the conductive adhesive (1300) filling the through-hole (1100) and an upper bonding portion and a lower bonding portion of the conductive adhesive (1300) formed on the upper and lower portions of the central pillar can be formed, respectively.

In the case where the sensor (400) and the main board (202) are simply attached to each other only through an adhesive means (such as 1300), at least a portion of the adhesive between the sensor (400) and the main board (202) may come off due to external force such as a significant level of vibration generated when attached to the human body, resulting in poor contact or signal. To prevent this, additional structures such as an FPCB, a connector, or a special fixing structure for the main board may be required.

However, when a conductive adhesive (1300) or a conductive adhesive (1300) structure penetrating the through-hole (1100) of the present invention is formed, the surface area to which the conductive adhesive (1300) is adhered significantly increases, so there is an advantage in that no separate additional structure is required for maintaining adhesion, as in the case where the sensor (400) and the main substrate (202) are mutually attached only through an adhesive means (such as 1300) as described above. Of course, even if a separate structure for adhesion is added, it can have much stronger conductivity or signal retention power than the case of simple adhesion.

According to FIGS. 2 and 3, in the first embodiment, the sensor (400) (or proximal portion (402)) and the main substrate (202) can be stacked in the order of the housing (208) of the transmitter (200).

In one embodiment of the housing (208), the housing (208) may be composed of an upper housing (210) and a lower housing (220), and after the main components of the transmitter (200), such as the sensor (400) and the main board (202), are built into the lower housing (220), the upper housing (220) may be assembled like a cap to complete the entire housing (208). In this case, the main components built into the transmitter (200) will be sequentially stacked in the lower housing (220), and therefore, in the embodiments, the housing (208) and the lower housing (220) are used interchangeably.

In the first embodiment, the step of attaching the sensor (400) and the main substrate (200) to the housing (208) may include at least one of a housing preparation step (S1100), a sensor mounting step (S1300), a main substrate mounting step (S1500), and a dispensing step (S1700).

The second embodiment has the same steps as the first embodiment, but the only difference is that the order of the sensor mounting step (S2500) and the main board mounting step (S2300) is reversed. That is, in the first embodiment, the sensor (400) is first mounted on the lower housing (220) and then the main board (200) is mounted, but in the second embodiment, the main board (202) is first mounted on the lower housing (220) and then the sensor (400) is mounted. Except for the difference in the mounting order between the sensor (400) and the main board (202) and the difference in the formation position of the through-hole (1100) due to this, anything that can be commonly applied to the first and second embodiments can be commonly extended and applied to both embodiments, even if it is described only in one embodiment.

The sensor (400) needs to have at least a part of the distal part (406) inserted into the skin, and the main board (202) needs to have major components built into the outer wall of the main board (202) for reasons such as water resistance, so in most cases, the proximal part (402) of the sensor (400) is thinner than the main board (202), so that the formation of the through-hole (1100) in the second embodiment can be relatively simpler than in the first embodiment. In addition, since the through-hole (1130) is formed in the sensor (400), the second embodiment has the advantage of being able to utilize the via-hole (411) that can interconnect the electric circuits on both sides as the through-hole (1130), regardless of the problem of connecting the sensor (400) and the transmitter (200) such as the main board (202), as well as the circuit configuration of the sensor (400) including the electrode (424), the lead (426), and the sensor pad (428).

In the housing preparation step (S1100), a housing (208) that forms the exterior of the transmitter (200) and protects the main components of the transmitter (200) by isolating them from the outside may be provided. If the housing (208) is composed of an upper housing (210) and a lower housing (220), this may be a step of preparing the lower housing (220). Through subsequent steps (including S1300 to S1700), the mutual positions of the sensor (400), the main board (202), the lower housing (220), etc., may be fixed to the lower housing (220).

In FIGS. 2 and 4, the distal portion (406) is exposed to the outside of the transmitter (200) through a hole in the lower surface of the lower housing (220) by being guided by the needle (300) at or near the middle portion (404), but this is for easy intuitive understanding, and the external exposure of the distal portion (406) by the needle (300) may be performed at any stage between the housing preparation step and the dispensing step (S1100 to S1700) illustrated, or may be performed after the housing preparation step (S1100) to the dispensing step (1700) are completed.

In the sensor mounting step (S1300), the sensor (400) can be attached to the lower housing (220). The portion of the sensor (400) to be attached can be at least a portion of the middle portion (404) to the proximal portion (402). The sensor (400) can be attached to the lower housing (220) by a first attachment structure (1510). The first attachment structure (1510) can be a first attachment member (1610) such as a double-sided tape disposed between the sensor (400) and the lower housing (220). (FIG. 2) That is, both sides of the first attachment member (1510) can be attached to the proximal portion (402) and the housing (208), respectively.

Alternatively, the first attachment structure (1510) may be an injection-molded groove guide type, and the injection-molded groove may be formed in the lower housing (220). In the case of the injection-molded groove guide type, at least a portion of the sensor (400) may be inserted or attached by being guided by an injection-molded groove formed in at least a portion of the housing (208).

In the main board mounting step (S1500), the main board (202) can be fixed in a relative position to the sensor (400) at an upper position of the sensor (400).

The main substrate (200) can be attached to the lower housing (220) (or the side surface of the lower housing (220)) by a second attachment structure (1520). The second attachment structure (1520) can be a separate jig that fixes the position of the main substrate (202) with respect to the sensor (400), or can be an injection-molded groove guide type, and the injection-molded groove can be formed in the lower housing (220) (or the side surface of the lower housing (220)). In the case of the injection-molded groove guide type, at least a portion of the main substrate (202) can be guided by an injection-molded groove formed in at least a portion of the housing (208) (the lower housing (220) or the side surface of the lower housing) and inserted or attached to the housing. In this case, the second attachment structure (1520) can include arranging a second attachment member (1620), such as a double-sided tape, between the main substrate (202) and the sensor (400) (FIG. 2). That is, the second attachment structure (1520) can be placed between the main substrate (202) and the electrochemical sensor (400), and both sides of the second attachment member (1620) can be attached to the main substrate (202) and the electrochemical sensor (400), respectively.

A through hole (1110) may be formed in the main substrate (202) of the main substrate mounting step (S1500). The through hole (1110) of the main substrate (202) may be formed to be aligned vertically with or correspond to the sensor pad (428) provided in the proximal portion (402). The number of through holes (1110) of the main substrate (202) may be provided as many as the number of sensor pads (428) that need to be connected to the contact pads (203). That is, the number of through holes (1110) may be determined according to the number of sensor pads (428) connected to the contact pads (203).

The through hole (1110) of the main substrate (202) is formed to penetrate the main substrate (202), and the inner wall of the through hole (1110) may be conductive or non-conductive.

In one embodiment, a through hole (1110) may be formed in the main substrate (202) in such a manner that a hole is formed in the main substrate (202) and a conductive material layer is formed in the hole to electrically connect both sides of the main substrate (202). Since this is similar to the process of forming a via hole (411) of an electrochemical sensor (400), it may be preferable that the inner wall of the through hole (1110) of the main substrate (202) in the first embodiment be conductive.

On the other hand, in the second embodiment, since the through hole (1130) is formed to penetrate the sensor (400) rather than the main board (202), this through hole (1130) may be the same as or include the via hole (411) used in the sensor circuit structure formed from the distal part (406) to the proximal part (402) of the sensor (400). Accordingly, the inner wall of the through hole (1130) of the sensor (400) of the second embodiment may be made of a conductive material.

In the case where a through hole (1110) is formed in the main substrate (202) as in the first embodiment, since it penetrates the main substrate (202), there is a limitation that components cannot be placed inside the main substrate (202) where the through hole (1110) is formed. If the area of the main substrate (202) where the through hole (1110) is formed is widely distributed, there are many limitations on the placement of components built into the main substrate (202), which may make it difficult to reduce the size of the main substrate (202). Therefore, so that the through hole (1110) is formed concentratedly in a certain area of the main substrate (202), the placement of the sensor pad (428) may also be affected so that it is created in a concentrated area with respect to each other.

In this way, in the case of the through hole (1110) of the main substrate, the position where the through hole (1110) is provided on the main substrate (202), the position of the components to be built into the main substrate (202), the position of the sensor pad (428) formed in the proximal portion (402), etc. can be determined to be interrelated.

When the position of the main substrate (202) is fixed in the main substrate mounting step (S1500), in the dispensing step (S1700), the conductive adhesive (1300) can be dispensed from a spraying device such as a nozzle into the through hole (1110) of the main substrate (202). The conductive adhesive (1300) dispensed into the through hole (1110) of the main substrate (202) can be injected into and filled into the through hole (1110), and the conductive adhesive (1300) passing through the through hole (1110) can fill the space between the back surface of the main substrate (202) and the upper surface of the sensor (400).

From FIG. 3, in the first embodiment, an electrical connection structure (1000) that electrically connects the sensor pad (428) and the contact pad (203) is described.

The sensor pad (428) may be provided on the upper surface of the proximal portion (402), and the contact pad (203) may be provided on the lower surface ((a) of FIG. 3) or the upper surface ((b) of FIG. 3) of the main substrate (202).

If there are no restrictions on the arrangement of the sensor pad (428) and the contact pad (203), the sensor pad (428) may be provided on the upper surface of the sensor (400) and the contact pad (203) may be provided on the lower surface of the main substrate (202) so that the two are formed as close as possible (a). However, in some cases, it may be more stable in terms of the electrical connection structure if at least some of the plurality of contact pads (203) are arranged on the upper surface of the main substrate (202) (b).

In the case where the sensor pad (428a) is formed on the upper surface of the sensor (400) and the contact pad (203a) is formed on the lower surface of the main substrate (202) (Fig. 3 (a)), the electrical connection structure (1000a) includes a conductive adhesive portion formed at the bottom of the through hole (1110).

That is, the electrical connection structure (1000a) in this case may include a sensor pad (428) formed on the upper surface of the electrochemical sensor (400), a contact pad (203) formed on the lower surface of the main substrate (202), and a conductive adhesive portion (1300) formed at the bottom of the through-hole (1110). Since the electrical connection structure (1000a) in this case does not include the conductive adhesive portion formed inside and above the through-hole (1110) as its components, the amount of the conductive adhesive (1300) sprayed in the dispensing step (S1700) can be adjusted so that only the conductive adhesive portion formed at the bottom of the through-hole (1110) is sufficiently formed.

Meanwhile, in the case where the sensor pad (428b) is formed on the upper surface of the sensor (400) and the contact pad (203b) is formed on the upper surface of the main substrate (202), the electrical connection structure (1000b) of (b) may include a conductive adhesive portion formed on the upper surface of the through-hole (1110), a conductive adhesive portion formed inside the through-hole (1110), and a conductive adhesive portion formed below the through-hole (1110). In this case, the amount of the conductive adhesive (1300) sprayed in the dispensing step (S1700) may be adjusted so that not only the inside of the through-hole (1110) is completely filled, but also the conductive adhesive portion formed on the upper surface of the through-hole (1110) can sufficiently coat the contact pad (203b).

According to FIGS. 3 and 4, a second embodiment of an electrical connection structure (2000) between a main board (202) and a sensor (400) is described. The description focuses on differences compared to the first embodiment, and contents that can be commonly applied to the first embodiment are omitted.

In the second embodiment, the main board (202), sensor (400) (or proximal portion (402)) can be stacked in the order of the housing (208) of the transmitter (200).

In the second embodiment, the step of attaching the sensor (400) and the main substrate (200) to the housing (208) may include at least one of a housing preparation step (S2100), a main substrate mounting step (S2300), a sensor mounting step (S2500), and a dispensing step (S2700).

In the second embodiment, there is a difference from the first embodiment in that the main board (202) is first mounted (S2300) on the lower housing (220) and then the sensor (400) is mounted (S2500).

In the main board mounting step (S2300), the main board (202) can be attached to the lower housing (220) (side or back of the lower housing (220)).

The main substrate (202) can be attached to the lower housing (220) by a first attachment structure (2510). The first attachment structure (2510) may be a first attachment member such as a double-sided tape disposed between the main substrate (202) and the lower housing (220). That is, the first attachment structure (2510) includes a first attachment member disposed between the main substrate (202) and the housing (208), and both sides of the first attachment member can be attached to the main substrate and the housing, respectively.

Alternatively, the first attachment structure (2510) may be an injection-molded groove guide type, and the injection-molded groove may be formed in the lower housing (220). In the case of the injection-molded groove guide type, at least a portion of the main substrate (202) may be guided and inserted or attached by an injection-molded groove formed in at least a portion of the housing (208).

In the sensor mounting step (S2500), the electrochemical sensor (400) can be fixed in a relative position to the main substrate (202) at an upper position of the main substrate (202). The portion of the sensor (400) to be attached can be at least a portion of the middle portion (404) to the proximal portion (402).

The sensor (400) can be attached to the main substrate (202) (or the upper surface of the main substrate) by a second attachment structure (2520). The second attachment structure (2520) can be a plurality of jig structures to fix the position of the sensor (400) to the main substrate (202), or can be an injection-molded groove guide type, and the injection-molded groove can be formed in the lower housing (220) (or the side surface of the lower housing (220)). In the case of the injection-molded groove guide type, at least a portion of the sensor (400) can be inserted or attached by being guided by an injection-molded groove formed in at least a portion of the housing (208) (the lower housing (220) or the side surface of the lower housing). In this case, the second attachment structure (2520) can include arranging a second attachment member (2620), such as a double-sided tape, between the sensor (400) and the main substrate (202) (FIG. 4).

In the second embodiment, a through hole (1130) may be formed in the main substrate (202) in the main substrate mounting step (S2300). In the case where the through hole (1130) (including the concept of a via hole (411)) is formed in the sensor (400) or the proximal portion (402), the via hole (411) introduced for configuring a double-sided electric circuit of the sensor (400) itself can be used as a through hole (1130) for injecting a conductive adhesive (2300), thereby simplifying the process. Since the step of forming the via hole (411) for manufacturing the sensor (400) or the step of adding the through hole (1130) for injecting the conductive adhesive (2300) can be performed, a separate process or equipment for forming the through hole (1130) can be omitted.

The through-hole (1130) of the sensor (400) may be formed to be aligned vertically with or correspond to the contact pad (203) of the main substrate (202). The number of through-holes (1130) of the sensor may be provided as many as the number of contact pads (203) to be connected to the sensor pad (428).

The through hole (1130) of the sensor (400) is formed to penetrate the sensor (400) or the proximal portion (402), and the inner wall of the through hole (1130) may be conductive.

For example, according to FIGS. 10 and 11, at least a portion of the inside of the through hole (1130) (including the via hole (411)) can be coated/filled with a conductive layer (412) by sputtering or the like.

The via hole step (S200) may be performed before the conductive layer step (S300) of forming an electrode (424) or a lead (426), and the via hole (411) may be formed by a laser etching method of removing a portion of the base layer (410) by irradiating the base layer (410) with a laser (490).

The conductive layer (412) can be formed by a physical vapor deposition method including sputtering in the conductive layer step (S300). The conductive layer (412) can be laminated with the same metal material without any joints along the upper surface of the base layer (410), the surface of the via hole (411), and the back surface of the base layer (410).

The conductive layer (412) formed inside the via hole (411) may be laminated only on the inner wall of the via hole (411) or may fill the entire via hole (411). However, in order for the conductive adhesive (2300) to be injected into the via hole (411) and to fill the space between the lower part of the sensor (400) and the main substrate (202), a sufficient space may be set inside the through hole (2300) for the conductive adhesive (2300) to pass through. If necessary, when there is not enough space for the via hole (411) for connecting the double-sided electric circuit of the sensor (400), the radius of the through hole (2300) may be set larger than that of the via hole (411).

Unlike the first embodiment, where a through hole (1110) is formed in the main substrate (202), which has a limitation that components cannot be placed inside the main substrate (202) where the through hole (1110) is formed, in the second embodiment, since the through hole (113) is provided in the sensor (400), the limitation on the placement of components built into the main substrate (202) can be eliminated.

Meanwhile, according to FIG. 10, since the electric circuit between the upper and lower surfaces of the sensor can be freely connected using the via hole (411), if the sensor pad (428) is formed only on one side of the proximal portion (402), the proximal opening (422a) only needs to be formed on that one side. However, even in this case, if the via hole (411) formed in the sensor pad (428) is used as a through hole (2300) into which a conductive adhesive (2300) is introduced, the proximal opening (422a) can be formed on both the upper and lower surfaces of the through hole (2300).

That is, a proximal opening (422a) can be formed correspondingly on both sides of the through-hole (2300) (or a via hole (411) used as the through-hole (2300)). At least a part of the sensor pad (428) can be exposed to the outside through the proximal opening (422a) in which at least a part of the insulating layer is cut away, and a part of the proximal portion (402) (or a part of the sensor pad (428)) exposed by the proximal opening (422a) can be electrically connected to the contact pad (203).

In addition, the via hole (411) can be divided into two types, a first via hole (411a) and a second via hole (411b). The first via hole (411a) can be blocked from the outside by an insulating layer (416), and the second via hole (411b) can have at least one side exposed to the outside. The via hole (411) used as the through hole (1130) of the second embodiment can be the second via hole (411b). In particular, in the distal portion (406), the electrode on one side of the base layer (411) and the electrode on the other side of the base layer (410) can be arranged and connected as the same electrode type by the second via hole (411b), thereby increasing the electrochemical reactivity between the electrode (424) and the reactant regardless of the directionality of the invaded distal portion (406).

The positions of the through-hole (1130) (or via-hole (411) to be used as the through-hole (1130)), the contact pad (203), and the sensor pad (428) may be aligned or correspond to each other along the vertical direction.

According to (b) and (c) of FIG. 5, regardless of whether an electric circuit is formed from the electrode (424) of the distal portion (406) at the via hole (411) stage (428b, 428c) or an electric circuit is formed from the electrode (424) of the distal portion (406) on only one side and the other side is opened only for the formation of the through hole (1130) (428d, 428e), the sensor pads (428b, 428c, 428d, 428e) formed in the openings of the proximal openings (422a) on both sides based on the through hole (1130) in the proximal portion (402) may be connected to the same type of electrode (for example, one of WE, CE, and RE) of the distal portion (406).

After the position of the sensor (400) is fixed in the sensor mounting step (S2500), in the dispensing step (S2700), a conductive adhesive (2300) can be dispensed from a spraying device such as a nozzle into the through-hole (1130) of the sensor (400). The conductive adhesive (2300) dispensed into the through-hole (1130) of the sensor (400) can be injected into and filled into the through-hole (1130), and the conductive adhesive (2300) passing through the through-hole (1130) can fill the space between the back surface of the sensor (400) and the upper surface of the main substrate (200).

From FIG. 5, in the second embodiment, an electrical connection structure (2000) that electrically connects the sensor pad (428) and the contact pad (203) is described.

The contact pad (230) may be provided on the upper surface of the main substrate (202), and the sense pad (428) may be provided on the lower surface ((a), (b), (c) of FIG. 5) or the lower surface ((b), (c) of FIG. 5) of the proximal portion (402).

If there are no restrictions on the arrangement of the sensor pad (428) and the contact pad (203), it may be preferable that the contact pads (203a, 203b, 203c) be provided on the upper surface of the main board (202) and the sensor pad (428) be provided on the lower surface (a) so that the two are formed as close as possible. However, in some cases, even if at least a part of the sensor pad (428) is arranged on the upper surface of the sensor (400), the electrical connection structure (2000b, 2000c) can be formed stably.

In the case where the contact pad (203) is formed on the upper surface of the main substrate (202) and the sensor pad (428) is formed on the lower surface of the sensor (400) (Fig. 5 (a)), the electrical connection structure (2000a) includes a conductive adhesive portion formed at the bottom of the through-hole (1130). In this case, the electrical connection structure (2000a) does not include the conductive adhesive portion formed inside and above the through-hole (1130) as its component, so the amount of the conductive adhesive (2300) sprayed in the dispensing step (S2700) can be adjusted so that only the conductive adhesive portion formed at the bottom of the through-hole (1130) is sufficiently formed.

Meanwhile, in the case where the contact pads (203a, 203b, 203c) are formed on the upper surface of the main substrate (202) and the sensor pad (428) is formed on the upper surface of the proximal portion (402) (b, c), the electrical connection structure (2000b, 2000c) may include a conductive adhesive portion formed on the upper surface of the through-hole (1130), a conductive adhesive portion formed inside the through-hole (1130), and a conductive adhesive portion formed below the through-hole (1130). In this case, the amount of the conductive adhesive (2300) sprayed in the dispensing step (S2700) may be adjusted so that not only the inside of the through-hole (1130) is completely filled, but also the conductive adhesive portion formed on the upper surface of the through-hole (1130) can sufficiently coat the sensor pads (428c, 428e).

In comparison with the case where the main substrate (202) and the sensor (400) are electrically connected to each other by simply applying a conductive adhesive (2300) between the sensor (400) and the main substrate (202) without a through-hole (1110, 1130), in the case where the conductive adhesive (1300, 2300) is injected through the through-hole (1110, 1130), the conductive adhesive portions are formed on the upper part of the through-hole, inside the through-hole, and lower part of the through-hole, so that the conductive adhesive is tightly fitted as if the connecting structure is made to fit the size of the through-hole (1130) exactly as shown in the drawing, and the bonding strength can be expected to be significantly improved compared to the case where the conductive adhesive (1300, 2300) is simply applied like double-sided tape between the main substrate (202) and the sensor (400).

After the dispensing or application of the conductive adhesive (1300, 2300) is completed, a molding portion (1700, 2700) may be formed on the conductive adhesive portion formed on the upper portion of the through-hole. The molding portion (2700) includes a non-conductive material such as epoxy, and the conductive adhesive portion formed on the upper portion of the through-hole is coated with a non-conductive material to prevent the conductive adhesive portions formed on the upper portion of the through-hole from short-circuiting each other or short-circuiting with an external component, thereby causing excessive current to flow.

<Inserter and Transmitter>

Fig. 6 may illustrate one embodiment of the connection between the inserter (100), the electrochemical sensor (400), and the transmitter (200) of the present invention. Fig. 1 may illustrate a state in which the electrochemical sensor (400) and the transmitter (200) are mounted inside the inserter (100) before leaving the inserter (100) and being invasive or attached to the body.

Referring to FIG. 6, the electrochemical sensor (400) of the present invention can be attached to the skin together with a transmitter (200). The transmitter (200) can control a signal measured by the electrochemical sensor (400) and continuously transmit the measured blood sugar level to an external terminal including a mobile device.

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

The electrochemical sensor (400) and transmitter (200) may be provided to the user in a state loaded in the inserter (100) prior to skin attachment. By the user's attachment action, the electrochemical sensor (400) and transmitter (200) may be detached from the inserter (100) and attached to the skin.

One end of the electrochemical sensor (400) connected to the electrical component (230) of the transmitter (200) may be referred to as the proximal end (402), the other end of the electrochemical sensor (400) at least part of which is invasive into the body may be referred to as the distal end (406), the part that interconnects the proximal end (402) and the distal end (406) and is positioned between the proximal end (402) and the distal end (406) may be referred to as the middle end (404), and the part of the middle end (404) that is flexibly bent and where the direction of the electrochemical sensor (400) is greatly changed may be referred to as the folding end (405).

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

The transmitter (200) and the electrochemical sensor (400) may be provided to the user in a state in which they are already bonded to each other before being attached to the skin.

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

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

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

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

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

The driving unit (102) can be connected to a needle handle (310) to which a needle (300) is fixed. The needle handle (310) can be attached to and detached from the driving unit (102).

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

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

A contact pad (203) electrically connected to a sensor pad (428) at the proximal portion (402) of the electrochemical sensor (400) can be formed on the main substrate (202).

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

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

Electrochemical sensor

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

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

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

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

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

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

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

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

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

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

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

When the transmitter (200) is attached to the skin and the electrochemical sensor (400) is invasive into the body, the folded portion (405) can remain in a bent state for a considerable period of time. To reduce the torsional load of the folded portion (405), the width of the middle portion (404) or the folded portion (405) can be formed to be narrower than the width of the proximal portion (402) or the distal portion (406).

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

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

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

The working electrodes, including the first working electrode (WE1) and the second working electrode (WE2), may be provided in multiple numbers on the same side of the distal portion (406), or at least one may be provided on both sides of the distal portion (406).

The biomarker to be reacted at the electrode (424) may include glucose, lactose, or ketone.

The first working electrode (WE1) and the second working electrode (WE2) are composed of the same type of biomarker to increase the response power and thus increase the detection accuracy of the electrochemical signal. The first working electrode and the second working electrode are composed of different types of biomarkers to simultaneously measure multiple electrochemical signals. In addition, the first working electrode and the second working electrode can be complementary in measuring a single biomarker. When the first working electrode measures the blood sugar concentration, the second working electrode can measure the concentration of acetaminophen. When taking acetaminophen, the blood sugar level measured in the body may be higher than the actual level, and the blood sugar concentration measured by the first working electrode needs to be judged by taking into account the acetaminophen concentration measured by the second working electrode.

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

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

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

A trench (420) may be engraved into the conductive layer (412), thereby allowing a conductive island (430) to be patterned into the conductive layer (412). The height of the trench (420) may be the same as the thickness of the conductive layer (412). The thicknesses of the conductive layer (412), the electrode (424), and the sensor pad (428) may all be the same.

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

The electrode (424) and the trench (420) can be formed without burrs by laser etching, no matter how complex the pattern of the electrode (424) is or how narrow the width of the trench (420). To simplify the process, it may be preferable that the conductive layer (412) is formed by sputtering a metal including gold or copper over the entire exposed area of the base layer (410).

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

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

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

When forming an electrode (424) on at least one surface of the distal portion (460), both the upper surface and the back surface of the base layer (410) on which the via hole (411) is formed can be sputtered with a metal or the like. The formation of this double-sided conductive layer (412) can be performed on the upper surface and the back surface at different times, or can be performed on both surfaces simultaneously.

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

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

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

A conductive layer (412) may be formed on the base layer (410) by sputtering or the like. The thickness of the conductive layer (412) formed by depositing metal by blowing it at the atomic or molecular level may be 10 micrometers or less. The conductive layer (412) may be formed by sputtering metal over the entire exposed area of the base layer (410) before the edge boundary of the electrode (424) and the edge boundary of the sensor pad (428) are formed.

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

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

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

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

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

When a via hole (411) is formed by cutting a portion of the base layer (412), the conductive layer (412) can be double-sided sputtered with the same metal material that is seamlessly continuous along the upper surface of the base layer (410), the surface of the via hole (411), and the back surface of the base layer (410).

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

A portion of the electrode (424) may be exposed to the outside through the distal opening (422b), and a portion of the electrode (424) exposed by the distal opening (422b) may come into contact with interstitial fluid or blood flow to cause an electrochemical reaction with the analyte.

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

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

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

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

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

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

The electrochemical sensor (400) can form a sensor array by interconnecting base layers (410). The electrochemical sensor (400) can be formed by at least one of forming a conductive layer (412) for each sensor on one base layer (410) and forming a trench (420) by laser etching, etc. The formation of an insulating layer (416) and a selectively transparent layer (418) can also be performed simultaneously.

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

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

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

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

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

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

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

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

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

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

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

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

The double-sided electrodes (424) formed on both sides of the distal portion (406) can be electrically connected to the sensor pads (428) on both sides of the proximal portion (402) along the double-sided leads (426) formed on both sides of the middle portion (404). In this case, a via hole (411) for electrically connecting the conductive layer (412) formed on one side of the base layer (410) and the conductive layer (412) formed on the other side of the base layer (410) may not need to be formed.

Meanwhile, if the sensor pad (428) is formed on both sides of the proximal portion (402), it may be difficult to electrically connect it with the contact pad of the main board (202) using a simple alignment method. For example, a cross-intersection structure or a separate connector portion for inserting or sandwiching the proximal portion (402) may be required to conduct current between the sensor pad (428) and the contact pad. Accordingly, the sensor pad (428) may be formed on only one side of the proximal portion (402).

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

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

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

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

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

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

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

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

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

By means of the second via hole (411b), the electrode on one side of the base layer (411) and the electrode on the other side of the base layer (411) can be arranged and connected as the same electrode type, thereby increasing the electrochemical reactivity between the electrode (424) and the reactant regardless of the directionality of the invaded distal portion (406).

Referring to FIG. 8, the trench (420) of the present invention will be described.

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

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

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

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

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

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

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

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

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

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

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

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

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

Area A of FIG. 8 may represent a part of the edge trench (420b).

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

The edge trench (420b) can prevent the conductive layer (412) from protruding to the side of the electrochemical sensor (400). The edge trench (420b) can serve to insulate the conductive island (430) located at the outermost part of the electrochemical sensor (400) from the outside of the sensor (400).

When electrochemical sensors (400) are processed as an array, the edge trench (420b) can prevent shorts between adjacent sensors (400) or between adjacent conductive islands (430) to prevent shorts from occurring between them.

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

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

According to FIG. 9, a method for manufacturing an electrochemical sensor (400) of the present invention is described in its entirety.

The method for manufacturing an electrochemical sensor of the present invention may include at least one of a step (S100) in which a base layer (410) is prepared, a via hole step (S200) in which a via hole (411) penetrating the base layer (410) is formed, a conductive layer step (S300) in which a conductive layer (412) is laminated on a flexible base layer (410) of the electrochemical sensor (400), a trench step (S400), an insulating layer step (S500), and a selective transmission layer step (S600).

In the via hole step (S200), the via hole (411) can be formed by a laser or mechanical method. The via hole (411) can be formed by a laser etching method in which a part of the base layer (410) is removed by irradiating the base layer (410) with a laser using a laser head (490).

The via hole step (S200) may be performed before the conductive layer step (S300) of forming an electrode (424) or a lead (426), etc.

According to FIGS. 10 and 11, the via hole (411) may include a first via hole (411a) and a second via hole (411b).

The first via hole (411a) can be blocked from the outside by an insulating layer (416), and the second via hole (411b) can be exposed to the outside through a distal opening (422b) formed on at least one of the two sides.

The insulation layer step (S300) may be a step of attaching an insulation layer (416) to a conductive layer (412).

In the conductive layer step (S300), the method for forming the conductive layer (412) may include a physical vapor deposition method including sputtering.

The conductive layer step (S300) may include a first conductive layer step of forming a first conductive layer on a first surface of the base layer (410), or a second conductive layer step of forming a second conductive layer on a second surface of the base layer (410).

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

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

Accordingly, the conductive layer (412) of the present invention can be formed as one layer or a layer that is identical to one layer on the inner surface of the via hole (411), the upper surface of the base layer (410), and the lower surface of the base layer (410), and can minimize short-circuit defects such as overlap at both ends of the via hole (411), and can also reduce the conductivity defect rate of the via hole (411) itself.

The trench step (S400) may be a step in which a trench (420) is formed in the conductive layer (412).

In the trench step (S400), the trench (420) can be formed by laser etching that removes a portion of the conductive layer (412) with a laser irradiated onto the conductive layer (412).

A heat treatment step may be performed after the conductive layer step (S300) or the insulating layer step (S500) as needed.

In the insulating layer step (S500), the first via hole (411a) can face the insulating layer (416), and the second via hole (411b) can face the opening (422) of the insulating layer (416).

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

The selective transmission layer step (S600) may be a step of applying a selective transmission layer (418) to the opening (422) of the insulating layer (416) by dispensing or the like.

The material of the selective permeable layer (418) may be determined depending on the type of body analyte to be electrochemically reacted with the electrode (424). For example, in the selective permeable layer step (S600), a selective permeable layer (418) containing platinum may be applied to the working electrode (WE), and a selective permeable layer (418) containing silver chloride may be applied to the reference electrode (RE).

After the selective permeation layer step (S600), a coating process such as a membrane may be additionally performed on the electrochemical sensor (400).

The sensor pad (428) can be exposed to the outside by the proximal opening (422a) of the proximal portion (402), and the electrode (424) can be exposed to the outside by the distal opening (422b) of the distal portion (406).

Whether the sensor pad (428) is placed on one side or both sides of the proximal portion (402) can be determined depending on how the proximal portion (402) is connected to the electrical component (230) of the transmitter (200).

Since the via hole (411) can freely form an electric circuit between one side and the other side of the base layer (410) depending on the arrangement of the sensor pad (428), the sensor pad (428) is not limited to the electrode (424) of the distal part (424) and can be freely formed depending on the method of connecting to the electrical component (230) of the transmitter (200) on one side or both sides of the proximal part (402).

In one embodiment of the electrochemical sensor (400) illustrated in FIG. 9, the sensor pad (428) of the proximal portion (402) may be formed on only one side, and the electrode (424) of the distal portion (406) may be formed on only one side.

The present invention is characterized by forming an electrode (424) only on one side of the distal portion (406). However, unlike other methods in which the electrode is simply formed on one side, the lead (426) of the present invention, which functions as a wire connecting the electrode (424) and the sensor pad (428), can be formed on the other side opposite the one side on which the electrode (424) is formed.

An electrode (424) may be placed on one surface of the base layer (410), and a lead (426) may be placed on the other surface of the base layer (410).

The conductive layer (412) may include a first conductive layer formed on a first surface of the base layer (410) and a second conductive layer formed on a second surface of the base layer (410), and a lead (426) electrically connecting between the electrode (424) and the sensor pad (428) may be provided, and a lead (426) may be formed on the second conductive layer, and an electrode (424) may be provided on the first surface of the base layer (410), and a lead (426) may be provided on the second surface of the base layer (410).

That is, the lead (426) may include a first lead formed on the opposite surface of the electrode (424) with respect to the base layer (410), and a second lead formed on a portion exposed in the same direction as the electrode (424) with respect to the base layer (410). The electrode (424) and the second lead may be exposed in the same direction with respect to the base layer (410). The first lead may be exposed in the opposite direction to the electrode (424) with respect to the base layer (410). The first lead may be formed on the second conductive layer, and the second lead may be formed on the first conductive layer.

A first lead may be provided at the distal portion (406), an electrode (424) may be provided at the distal portion (406), and an electrochemical signal obtained through the electrode (424) of the first surface with respect to the base layer (410) may be electrically transmitted to the first lead through a via hole (411) penetrating the base layer (410).

A second lead may be provided at the proximal portion (402), and an electrochemical signal obtained from the electrode (424) may be transmitted to the second lead via the first lead, and the signal transmitted to the second lead may be electrically conducted and transmitted to the transmitter (200).

Due to these characteristics, the manufacturing method and structure of the sensor (400) of the present invention are differentiated from sensors (400) manufactured by other methods.

The sensor (400) of the present invention may include a via hole step (S200) even though the electrode (424) is formed on only one side. In this case, the via hole (411) may not be for conducting between the electrodes formed on both sides, but may be for interconnecting the electrode (424) and the leads (426) corresponding to each electrode (424) on the opposite side.

In addition, the sensor (400) of the present invention may be subjected to double-sided sputtering on both sides of the distal portion (406) in the conductive layer step (S300), even though the electrode (424) is formed on only one side, and double-sided laser etching, etc. may be performed on both sides of the distal portion (406) to form a trench (420) in the trench step (S400).

In the insulating layer step (S500), a distal opening (422b) may be formed on one side of the distal portion (406) where the electrode (424) is provided, in which a portion of the insulating layer (416) is cut off, and a distal opening (422b) may not be formed on the other side of the distal portion (406) where the lead (426) is provided. The other side where the lead (426) is provided does not require an opening for forming the electrode (424), thereby reducing contamination due to external exposure.

The selective permeable layer (418) of the selective permeable layer step (S600) can be applied only to one side of the distal portion (406) where the electrode (424) is formed.

The second via hole (411b) may have at least one surface exposed to the outside, but when the electrode (424) is formed only on one surface of the base layer (410), one surface of the second via hole (411b) may be exposed to the outside, and the other surface of the second via hole (411b) may be blocked by the bonding layer (414) or the insulating layer (416) and may not be exposed to the outside.

In addition, when an electrode (424) is arranged on one surface of the base layer (410) and a lead (426) is arranged on the other surface of the base layer (410), each electrode (424) can be arranged so that the exposed area of all electrodes (424) is the same, since no lead (426) is formed around the electrode (424), regardless of the type of electrode (424) including a reference electrode (RE), a counter electrode (CE), and a working electrode (WE). Due to this, the dispensing process of platinum, etc. in the selective transmission layer step (S600) can be applied equally to all electrodes, thereby improving process accuracy and process speed.

That is, an electrode (424) may be provided on the first surface of the base layer (410). A lead (426) may not be provided around the electrode (424) and may be provided on the second surface of the base layer (410).

Meanwhile, FIG. 7 shows an example of a transmitter (200) combined with an electrochemical sensor (400).

A first embodiment may be a case where a needle through-hole is formed in the upper housing (210) and the lower housing (220) of the transmitter (200). When inserted, the needle passes through the through-hole formed in the upper housing (210) and the through-hole formed in the lower housing (220) of the transmitter (200) in sequence, and when detached, the needle passes through the through-hole in the opposite order and is detached from the transmitter (200). The electrochemical sensor (400) is exposed to the through-hole so as to be aligned with the needle.

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

A second embodiment according to FIG. 7 may be a case where a recessed portion (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, a single outer sealing member is sufficient, and an inner sealing member may not be required. In addition, the pillar structure of the upper housing (210) and lower housing (220) for forming the central through hole is also not required.

Instead of the through hole of the transmitter (200), a recessed portion (204) can take its place, and at least a portion of the needle (300) can pass through the recessed portion (204) that functions as a back hole of the housing (208). That is, the sensor (400) mounted on the transmitter (200) can have at least a portion of the proximal portion (402) attached to the main board (202), and the middle portion (404) or the distal portion (406) can pass through the recessed portion on the side of the main board (202), or the recessed portion (204) that recesses the side of the transmitter (200) and be exposed to the outside of the transmitter (200).

Therefore, in the second embodiment, when the through-holes and the pillar structures at the through-hole locations of the first embodiment of the transmitter (200) are deleted, even if the transmitter (200) has the same diameter, the internal space of the transmitter (200) is significantly expanded. The expanded space can extend the service life due to the installation of a large-capacity battery, and can reduce the user's transmitter replacement cost. Meanwhile, it can also contribute to improved performance by obtaining an optimized arrangement of electronic components and freedom in the design of the main board.

11... ACF 13... Soldering paste
15... FPCB 17... Connector
100... Inserter 102... Drive
200... Transmitter 202... Main board
203,203a,203b,203c... contact pads
204... Depression 208... Housing
210... upper housing 220... lower housing
230... Electrical component 230a... 1st electrical component
230b... 2nd electrical component 300... needle
310... Needle handle 400... Electrochemical sensor
402... Guard 404... Middle
405... Folding part 406... Distal part
410... Base layer 411... Via hole
411a... First via hole 411b... Second via hole
412... Conductive layer 414... Bonding layer
416... Insulating layer 418... Selective transmission layer
418a... First selective permeable layer 418b... Second selective permeable layer
418c... 3rd selective permeable layer 418d... 4th selective permeable layer
420a... inner 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... 1st lead 426b... 2nd lead
426c... 3rd lead 428... sensor pad
428a... First sensor pad 428b... Second sensor pad
428c... 3rd sensor pad 428d... 4th sensor pad
428e... 5th sensor pad 430... conductive island
430a... 1st conductive island 430b... 2nd conductive island
430c... 3rd conductive island 432... dummy part
432a... 1st dummy section 432b... 2nd dummy section
490... laser head
1000,1000a,1000b,2000,2000a,2000b,2000c... Electrical connection structure
1100... through hole 1110... through hole on main board
1130... Through-hole electrochemical sensor
1300,1300a,1300b,2300,2300a,2300b,2300c... conductive adhesive
1500,2500... Attachment structure 1510,2510... First attachment structure
1520,2520... Second attachment structure 1600,2600... Attachment member
1610,2610... First attachment member 1620,2620... Second attachment member
1700, 2700... Molding part S100... Base layer preparation stage
S200... Via hole stage S300... Conductive layer stage
S400... Trench stage S500... Insulation layer stage
S600... Selective Transmission Layer Stage S1100, S2100... Housing Preparation Stage
S1300, S2500... Sensor mounting step S1500, S2300... Main board mounting step
S1700,S2700... Dispensing step W1,W2... Trench width

Claims (22)

An electrochemical sensor comprising a distal portion having a plurality of electrodes formed thereon that react with an analyte in the body and a proximal portion having sensor pads formed thereon that are connected to the electrodes;
A transmitter comprising a main substrate having at least one of a power supply unit, a communication unit, and a control unit formed thereon, a housing in which the main substrate is housed, wherein a contact pad electrically connected to the sensor pad is formed on the main substrate, and the housing is attached to the skin;
An electrical connection structure is formed between the sensor pad and the contact pad,
The electrical connection structure includes a through-hole or conductive adhesive,
The above conductive adhesive mutually fixes and conducts the sensor pad and the contact pad together,
The conductive adhesive is injected into the above through hole,
The above through-hole is a continuous analyte measuring device formed in the electrochemical sensor.
In the first paragraph,
The above main board is first mounted on the housing, and then the electrochemical sensor is mounted.
A continuous analyte meter stacked in the housing of the transmitter in the order of the main substrate and electrochemical sensor.
In the first paragraph,
A via hole is provided that penetrates the electrochemical sensor and interconnects the electric circuits formed on both sides of the electrochemical sensor.
A continuous analysis measuring device in which the above via hole is used as a through hole into which the above conductive adhesive is injected.
In the first paragraph,
The electrochemical sensor comprises a flexible base layer, a conductive layer laminated on the base layer, an insulating layer attached on the conductive layer, and a selective transmission layer applied to the conductive layer.
A via hole is provided that penetrates the electrochemical sensor and interconnects the electric circuits formed on both sides of the electrochemical sensor.
The above via hole is used as a through hole into which the conductive adhesive is injected.
The above via hole includes a first via hole and a second via hole,
The above first via hole is blocked from the outside by the insulating layer,
The above second via hole has at least a portion of both sides exposed to the outside,
The above through-hole is a continuous analyte measuring device including the second via-hole.
In the first paragraph,
The above-mentioned conductive adhesive is dispensed from a spraying device including a nozzle into the through-hole of the electrochemical sensor,
A continuous analyte measuring device in which a conductive adhesive dispensed into a through-hole of the electrochemical sensor is injected into and filled into the through-hole, and the conductive adhesive passing through the through-hole fills a space between the back surface of the electrochemical sensor and the upper surface of the main substrate.
In the first paragraph,
A continuous analysis measuring device in which, when the conductive adhesive is injected into the through-hole while the above-mentioned proximal portion and the above-mentioned main substrate are facing each other or fixed to each other, a central pillar of the conductive adhesive filling the through-hole and an upper bonding portion and a lower bonding portion of the conductive adhesive formed on the upper and lower portions of the central pillar are formed, respectively.
In the first paragraph,
Sensor pads are formed on both sides based on the above through-hole,
A continuous analyte measuring device in which the sensor pads on both sides of the above through-hole are connected to the same type of electrodes of the above distal portion.
In the first paragraph,
The through-hole of the above electrochemical sensor is formed to be aligned or correspond to the contact pad of the main substrate in the vertical direction,
A continuous analyte measuring device in which the through-holes of the electrochemical sensor are formed to correspond to the number of contact pads to be connected to the sensor pad.
In the first paragraph,
The above main board is attached to the housing by a first attachment structure,
The first attachment structure includes a first attachment member disposed between the main substrate and the housing,
A continuous analysis measuring device in which both sides of the first attachment member are attached to the main substrate and the housing, respectively.
In the first paragraph,
The above main board is attached to the housing by a first attachment structure,
The above first attachment structure is an injection molding groove guide type,
The above injection groove is formed in at least a portion of the housing,
A continuous analysis measuring device in which at least a portion of the main substrate is inserted or attached by being guided by the injection groove.
In the first paragraph,
The electrochemical sensor is fixed in a relative position to the main substrate on the upper side of the main substrate,
The above electrochemical sensor is attached to the housing by a second attachment structure,
The above second attachment structure is a continuous analyte measuring device that fixes the position of the electrochemical sensor to the main substrate by a separate jig.
In the first paragraph,
The electrochemical sensor is fixed in a relative position to the main substrate on the upper side of the main substrate,
The above electrochemical sensor is attached to the housing by a second attachment structure,
The above second attachment structure is an injection molding groove guide type,
The above injection groove is formed in at least a portion of the housing,
A continuous analyte meter wherein at least a portion of the electrochemical sensor is guided by the injection groove and inserted or attached to the housing.
In the first paragraph,
The electrochemical sensor is fixed in a relative position to the main substrate on the upper side of the main substrate,
The above electrochemical sensor is attached to the housing by a second attachment structure,
The second attachment structure includes a second attachment member disposed between the main substrate and the electrochemical sensor,
A continuous analyte measuring device in which both sides of the second attachment member are attached to the main substrate and the electrochemical sensor, respectively.
In the first paragraph,
The electrochemical sensor comprises a flexible base layer, a conductive layer laminated on the base layer, an insulating layer attached on the conductive layer, and a selective transmission layer applied to the conductive layer.
The above through hole is formed to penetrate the electrochemical sensor or the proximal part,
The inner wall of the above through-hole is the above conductive layer, and is a conductive continuous analyte measuring device.
In the first paragraph,
The electrochemical sensor comprises a flexible base layer, a conductive layer laminated on the base layer, an insulating layer attached on the conductive layer, and a selective transmission layer applied to the conductive layer.
At least a portion of the above sensor pad is exposed to the outside through a proximal opening cut through at least a portion of the above insulating layer,
A continuous analysis measuring device in which the proximal opening is formed at both ends of the above through hole.
In the first paragraph,
The main substrate and electrochemical sensor are laminated on the inner back surface of the housing of the transmitter in that order,
The above contact pad is formed on the upper surface of the main substrate,
A continuous analyte measuring device wherein the sensor pad is formed on the lower surface of the electrochemical sensor, or at least some of the plurality of sensor pads are disposed on the upper surface of the electrochemical sensor.
In the first paragraph,
The main substrate and electrochemical sensor are laminated on the inner back surface of the housing of the transmitter in that order,
The above electrical connection structure is,
A continuous analyte measuring device comprising the contact pad formed on the upper surface of the main substrate, the sensor pad formed on the lower surface of the electrochemical sensor, and a conductive adhesive portion formed on the lower portion of the through-hole.
In the first paragraph,
The main substrate and electrochemical sensor are laminated on the inner back surface of the housing of the transmitter in that order,
The above electrical connection structure is,
Contact pads formed on the upper surface of the main substrate,
At least some of the plurality of sensor pads arranged on the upper surface of the electrochemical sensor,
A conductive adhesive portion formed on the upper portion of the above through hole,
A conductive adhesive portion formed inside the above through hole, and
A continuous analytical measuring device comprising a conductive adhesive portion formed at the bottom of the above through hole.
In the first paragraph,
The above-mentioned conductive adhesive is dispensed from a spraying device including a nozzle into the through-hole of the electrochemical sensor,
A continuous analyte meter in which at least a portion of the electrochemical sensor is guided by a needle and exposed to the outside of the transmitter through a hole in the lower surface of the housing after the conductive adhesive is dispensed into the through-hole.
In the first paragraph,
A continuous analysis measuring device in which a non-conductive molding part is formed on the conductive adhesive portion formed on the upper portion of the through-hole after dispensing the conductive adhesive into the through-hole.
In the first paragraph,
The electrochemical sensor comprises a flexible base layer, a conductive layer laminated on the base layer, an insulating layer attached on the conductive layer, and a selective transmission layer applied to the conductive layer.
A continuous analyte measuring device in which the conductive layer is laminated with the same metal material without any joints along the upper surface of the base layer, the surface of the via hole, and the back surface of the base layer.
In the first paragraph,
The above transmitter has a recessed portion formed on the side,
A continuous analyte meter wherein at least a portion of the proximal portion is attached to the main substrate, and the distal portion is exposed to the outside of the transmitter through at least a portion of the recessed portion.