KR20230042871A - Continous glucose monitoring system with micro needle bio sensor - Google Patents

Abstract

The present invention provides a continuous blood glucose detection system including a microneedle biosensor, which enables accurate sensing while reducing a user's pain when worn. According to the present invention, the microneedle biosensor includes a working electrode, a counter electrode, a reference electrode, and an adhesive sheet. The working electrode includes a circular first base, a plurality of microneedles protruding vertically from the first base, and a first wire extending vertically from one end of the first base.

Description

CONTINOUS GLUCOSE MONITORING SYSTEM WITH MICRO NEEDLE BIO SENSOR}

The present invention relates to a continuous blood glucose monitoring system including a microneedle biosensor.

Normal human blood glucose levels are within the range of 70 to 130 mg/dL before meals and within the range of 180 mg/dL after meals. If it exceeds this range, it is classified as hyperglycemia, and if it is below the normal range, it is classified as hypoglycemia. Hyperglycemia is highly correlated with diabetes. Diabetes mellitus refers to a group of metabolic diseases in which high blood sugar levels persist for a long period of time.

In order to diagnose diabetes and manage it so that it does not develop into complications, systematic blood glucose measurement and treatment must be performed simultaneously. In general, diabetes is managed by determining an injection amount of insulin according to a patient's blood sugar level and administering insulin at predetermined time intervals. However, since the blood glucose level of each patient and the change in blood sugar according to insulin administration are different for each individual patient, it is difficult to accurately and efficiently determine the insulin dose, administration time, and interval.

To solve this problem, a continuous glucose monitoring (CGM) system may be used. Continuous blood glucose monitoring system was first developed by Medtronic (Minneapolis, MN, USA) and was approved by the US FDA in June 1999. CGM consists of three parts: a blood glucose sensor, a wireless transmitter, and a receiver. The sensor is inserted into the subcutaneous fat to measure sugar in the interstitial fluid. The latest version of the continuous blood glucose monitor shows blood glucose readings in real time, allowing immediate action to be taken.

A conventional continuous blood glucose monitoring device includes a sensor inserted into the body to measure blood glucose, a needle for guiding the sensor to be inserted into the body, and a separate applicator coupling structure to apply the sensor module to the body. The sensor is disposed in the hollow of the syringe needle, pierced subcutaneously by the syringe needle, and inserted into the subcutaneous fat. A sensor is placed in the hollow of the syringe needle. Syringe needles are used up to 21 Gauge in size when blood glucose is detected, and since a sensing strip must be placed in the hollow of the syringe needle, a syringe needle used as a sensor needle in a continuous blood glucose measurement device is generally used with a diameter of 600 nm to 800 nm. When the diameter of the sensor needle is 600 nm to 800 nm, there is a problem of causing pain to the user and giving discomfort during continuous use.

Republic of Korea Patent No. 10-1773583 Republic of Korea Patent Publication No. 10-2017-0038351 Republic of Korea Patent Publication No. 10-2018-0072386 PCT International Publication No. WO 2017-116503

The present invention has been made to solve the problems of the prior art, and an object of the present invention is to provide a continuous blood glucose sensing system including a microneedle biosensor capable of reducing pain for a user when worn with minimal invasiveness.

The present invention,

a working electrode including a first base of a circular thin film, a plurality of microneedles protruding vertically on the first base, and a first wire extending from one end of the circumference of the first base;

A second base of a strip-shaped thin film concentrically with the first base and spaced apart from the circumference of the first base by a set distance and having a 3/4 circumference, a plurality of microneedles protruding vertically on the second base, and the first a counter electrode including a second wiring extending from one end of the second base to be disposed horizontally with the wiring; and

A third base of a strip-shaped thin film of 1/4 circumference, spaced apart from the other end of the second base by a set distance, concentric with the first base and spaced from the circumference of the first base by a set distance, and protruding vertically on the third base A microneedle biosensor including a reference electrode including a plurality of microneedles, a third wire extending from one end of the third base,

an integrated management unit that monitors whether the microneedle biosensor is operating, receives blood glucose data measured from the microneedle biosensor wired/wireless, and filters, analyzes, compares, stores, transmits, and displays the blood sugar data; and

Provided is a continuous blood glucose sensing system including a microneedle biosensor including a data transceiver for wired/wireless transmission of data received from the integrated management unit.

Bottom surfaces of the first base, the second base, and the third base are attached to an adhesive sheet.

The first wiring extends vertically from one end of the circumference of the first base,

The second wire extends from one end of the second base so as to be disposed horizontally with the first wire,

The third wire is characterized in that it extends from one end of the third base to be disposed horizontally with the first wire.

According to an embodiment of the present invention configured as described above, it is possible to provide a continuous blood glucose detection system including a microneedle biosensor that can reduce user's pain when worn, enable accurate sensing, and is most suitable for the skin surface shape.

1 is a diagram showing a microneedle biosensor according to an embodiment of the present invention.
2 is a diagram showing a microneedle biosensor and a transmitter connected thereto.
FIG. 3 is a view illustrating the fabrication of a microneedle biosensor wired and bonded to an FFC cable.
FIG. 4 is a structural diagram for explaining FIG. 3 .
5 is a diagram illustrating a continuous blood glucose sensing system including a microneedle biosensor according to an embodiment of the present invention.

The present invention will be described in detail with reference to the accompanying drawings. Here, the same reference numerals are used for the same components, and repeated descriptions and detailed descriptions of well-known functions and configurations that may unnecessarily obscure the gist of the present invention are omitted. Embodiments of the present invention are provided to more completely explain the present invention to those skilled in the art. Accordingly, the shapes and sizes of elements in the drawings may be exaggerated for clarity.

A microneedle biosensor according to an embodiment of the present invention is a minimally invasive microneedle biosensor. The present invention relates to a biosensor in which a microneedle invades the skin and contacts a body fluid to monitor a biosignal. The biosensor according to an embodiment of the present invention is intended to measure the blood glucose concentration in the interstitial fluid (ISF) of an invaded host, and is meant to be mounted on the skin surface to continuously measure the blood glucose concentration for a set period of time. Not limited.

1 is a diagram showing a microneedle biosensor according to an embodiment of the present invention. As shown, the microneedle biosensor includes a working electrode (WE) 110, a counter electrode (CE) 120, a reference electrode (RE) 130, and an adhesive sheet 200. ). The working electrode 110 includes a circular first base 111, a plurality of microneedles 112 vertically protruding on the first base 111, and a second vertically extending from one end of the first base 111. It includes 1 wire (113). The counter electrode 120 includes a second base 121 concentrically with the first base 111 and formed in a strip shape of a 3/4 circumference spaced apart from the circumference of the first base 111 by a set interval, the second base 121 It includes a plurality of microneedles 122 vertically protruding from the base 121 and a second wire 123 extending from one end of the second base 121 so as to be disposed horizontally with the first wire 113. . A third base formed in a strip shape of a 1/4 circumference spaced apart from the other end of the second base 121 by a set interval and concentrically with the first base 111 and spaced apart by a set interval from the circumference of the first base 111 131, a plurality of microneedles 132 vertically protruding on the third base 131, extending vertically from one end of the third base 131 to be disposed horizontally with the first wiring 113 It includes a third wiring 133 that

The counter electrode 120 and the reference electrode 130 are spaced apart from the working electrode 110 at set intervals and are arranged to surround the working electrode 110 . The working electrode 110, the counter electrode 120, and the reference electrode 130 are attached to the adhesive sheet 200. In the adhesive sheet 200, it is preferable that an adhesive is applied to one surface of a fiber or polymer sheet. The adhesive sheet 200 preferably has elasticity in itself. In the adhesive sheet 200, the working electrode 110, the counter electrode 220, and the reference electrode 130 are attached to a surface on which an adhesive capable of attaching to the skin is applied. The circular working electrode 110 and the counter electrode 120 and the reference electrode 130 are disposed so as to surround the working electrode 110 and form a strap shape spaced apart from the working electrode 110, and a sheet made of a fiber or polymer material. Since the working electrode 110, the counter electrode 220, and the reference electrode 130 are attached to the skin of the human body, which cannot be structurally flat while securing a sufficient effective area for sensing, each flexibly angles the skin. It can be tilted according to the skin contact surface and attached closely. That is, in the case of a sensor with a flat base, when attached to the skin rather than a flat surface, as time elapses after attachment, a phenomenon in which the edge is lifted due to resilience occurs, but the microneedle biosensor according to an embodiment of the present invention can solve such a problem. there will be

FIG. 2 is a diagram showing a microneedle biosensor and a transmitter connected thereto, FIG. 3 is a diagram showing manufacturing a microneedle biosensor wired and bonded to an FFC cable, and FIG. 4 is a structural diagram for explaining FIG. 3 .

5 is a diagram illustrating a continuous blood glucose sensing system including a microneedle biosensor according to an embodiment of the present invention.

Claims (3)

a working electrode including a first base of a circular thin film, a plurality of microneedles protruding vertically on the first base, and a first wire extending from one end of the circumference of the first base;
A second base of a strip-shaped thin film concentrically with the first base and spaced apart from the circumference of the first base by a set distance and having a 3/4 circumference, a plurality of microneedles protruding vertically on the second base, and the first a counter electrode including a second wiring extending from one end of the second base to be disposed horizontally with the wiring; and
A third base of a strip-shaped thin film of 1/4 circumference, spaced apart from the other end of the second base by a set distance, concentric with the first base and spaced from the circumference of the first base by a set distance, and protruding vertically on the third base A microneedle biosensor including a reference electrode including a plurality of microneedles, a third wire extending from one end of the third base,
an integrated management unit that monitors whether the microneedle biosensor is operating, receives blood glucose data measured from the microneedle biosensor wired/wireless, and filters, analyzes, compares, stores, transmits, and displays the blood sugar data; and
A continuous blood glucose sensing system including a microneedle biosensor including a data transceiver for wired/wireless transmission of data received from the integrated management unit. According to claim 1,
The continuous blood glucose sensing system including a microneedle biosensor, characterized in that bottom surfaces of the first base, the second base, and the third base are attached to an adhesive sheet. According to claim 1,
The first wiring extends vertically from one end of the circumference of the first base,
The second wire extends from one end of the second base so as to be disposed horizontally with the first wire,
The continuous blood glucose sensing system including a microneedle biosensor, characterized in that the third wire extends from one end of the third base so as to be disposed horizontally with the first wire.

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