WO2019027277A1

WO2019027277A1 - Blood glucose meter and method for measuring blood glucose using same

Info

Publication number: WO2019027277A1
Application number: PCT/KR2018/008815
Authority: WO
Inventors: 황인식; 김해란; 윤인준; 한대우; 김동철
Original assignee: 주식회사 드림보우
Priority date: 2017-08-04
Filing date: 2018-08-03
Publication date: 2019-02-07

Abstract

A blood glucose meter according to an embodiment of the present invention is placed on the skin to measure blood glucose, the blood glucose meter comprising: an electrode unit arranged at a certain position on the skin to apply a current to the body; and a sensor unit penetrating under the skin to measure glucose, wherein the electrode unit comprises a positive (+) electrode unit and a negative (-) electrode unit, and a separation distance between the end of the sensor unit and the negative (-) electrode unit is different from a separation distance between the end of the sensor unit and the positive (+) electrode unit.

Description

Blood glucose meter and method for measuring blood glucose using the same

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood glucose meter and a blood glucose measuring method using the same. More particularly, the present invention relates to a blood glucose meter for measuring blood glucose and a blood glucose measuring method using the same.

Many diagnostic tests are routinely performed on humans to assess the amount or presence of substances in blood or other body fluids.

Diabetes is a major health concern, and treatment of Type I (insulin-dependent) diabetes, a more severe form of the condition, requires one or more insulin injections daily. Insulin controls the use of glucose or sugars in the blood and prevents hyperglycemia that can become ketosis if left untreated.

It is essential to monitor blood glucose levels frequently as a means of avoiding or at least minimizing the complications of Type I diabetes. In addition, it is essential that patients with Type II (non-insulin dependent) diabetes monitor their blood glucose levels periodically, while controlling their condition by diet and exercise.

Conventional blood glucose monitoring methods generally use an invasive glucose monitoring system using a needle-shaped glucose sensor. However, there has been a problem of insertion pain, foreign body sensation, infection possibility, and the like due to the use of a needle sensor. In addition, since only a very small amount of cluchose that comes into contact with the needle sensor is measured, there is a problem that accuracy is lowered.

In order to compensate for the disadvantages of insertion of the needle sensor described above, noninvasive blood glucose measurement methods using a reverse ionization method have been developed. However, since the blood glucose measurement method using the reverse movement electrophoresis method measures the glucose by extracting the intracellular fluid onto the skin, it is possible to measure a much smaller amount of clearance than the invasive blood glucose measurement method using the needle sensor, (Sweat, body hair, etc.).

On the other hand, Korean Patent No. 10-1512566 discloses a conventional blood glucose meter.

Disclosure of Invention Technical Problem [8] Accordingly, the present invention has been made in view of the above problems, and it is an object of the present invention to provide a blood glucose meter capable of measuring blood glucose with a small amount of foreign objects.

It is to be understood that the present invention is not limited to the above-described embodiments and that various changes and modifications may be made without departing from the spirit and scope of the present invention as defined by the following claims .

The blood glucose meter according to an embodiment of the present invention measures blood glucose by being installed on the skin. The blood glucose meter is disposed at a predetermined position of the skin and applies current to the body. (-) electrode unit, and the distance between the end of the sensor unit and the (-) electrode unit is smaller than the distance between the sensor unit and the (-) electrode unit, And the distance between the end portion and the (+) electrode portion.

According to the blood glucose meter of the embodiment of the present invention, there is an advantage that the foreign body sensation is small and the blood glucose can be accurately measured.

The effects of the present invention are not limited to the above-mentioned effects, and the effects not mentioned can be clearly understood by those skilled in the art from the present specification and the accompanying drawings.

1 is a schematic view showing a blood glucose meter according to an embodiment of the present invention installed on a human body.

2 and 3 are schematic sectional views of a blood glucose meter according to an embodiment of the present invention.

4 is a schematic sectional view showing another embodiment of the blood glucose meter of the present invention.

5 is a schematic block diagram of a blood glucose meter of the present invention.

FIG. 6 is a schematic flowchart of a blood glucose measurement method according to another embodiment of the present invention. FIG.

Hereinafter, specific embodiments of the present invention will be described in detail with reference to the drawings. It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the inventive concept. Other embodiments falling within the scope of the inventive concept may readily be suggested, but are also considered to be within the scope of the present invention.

The sensor unit may further include a position defining unit that defines a positional relationship between the electrode unit and the sensor unit.

In addition, the electrode portion is fixed at a predetermined position on the position regulating portion, and the sensor portion can be subcutaneously penetrated at a predetermined position on the position regulating portion.

The position regulating portion may include an infiltration inducing portion for defining a position where the sensor portion is subcutaneously injected, and the sensor portion may be subcutaneously infiltrated through the infiltration inducing portion.

In addition, the infiltration inducing portion may be formed as a through space.

The sensor unit may further include a guide unit disposed on the through space to guide the sensor unit and the position defining unit apart from each other in the through space and to guide the sensor unit into the subcutaneous space.

The distance between the end of the sensor part and the (-) electrode part may be smaller than the distance between the end of the sensor part and the (+) electrode part.

In addition, the end of the sensor portion may be disposed in a footprint occupied by the negative (-) electrode portion.

The blood glucose measurement method according to another embodiment of the present invention may be a method of measuring blood glucose using the blood glucose meter.

The same reference numerals are used to designate the same components in the same reference numerals in the drawings of the embodiments.

FIG. 5 is a schematic block diagram of a blood glucose meter of the present invention, and FIG. 6 is a schematic flowchart of a blood glucose measurement method according to another embodiment of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.

As shown in FIG. 1, the blood glucose meter 100 according to the embodiment of the present invention may be configured to apply reverse ionization.

For example, the blood glucose meter 100 may be configured to apply an immunoassay / semi-invasive blood glucose measurement principle using reverse ionization.

For example, the blood glucose meter 100 may include a transmitter 10, an electrode unit 20, and a glucose sensor 30.

For example, the transmitter 10 transmits data relating to the glucose concentration value or blood sugar value measured by the glucose sensor 30 to an output device (not shown) including the receiver.

The output device can use various known output devices (PC, smartphone, clock-type output device, etc.).

The electrode unit 20 is formed to include a negative pole 21 and a positive pole 22. The negative electrode 21 and the negative electrode 21 are formed by reversing ionization so that a sufficient amount of glucose can be collected toward the negative electrode 21 And is responsible for applying current to the body.

At this time, the material of the electrode unit 20 may be an electrode containing platinum (Pt), gold (Au), silver (Ag) and carbon (C) or a silver / silver chloride And it is possible to form the electrode portion 20 in various materials.

The electrode portion 20 can be manufactured by any known method, for example, a screen printing method, sputtering or the like.

At this time, it is also possible to form the electrode unit 20 in the form of a semi-invasive or fully invasive needle and insert it into the skin layer (semi-invasive) or subcutaneous (complete invasion).

The glucose sensor 30 may be formed in the form of a structure such as a fine needle or a needle, and an enzyme electrode (not shown) may be formed therein to be implanted subcutaneously in a surgical manner to directly measure the concentration of glucose in the intercellular fluid Can play a role.

Since the concentration of glucose in the intracellular fluid and the concentration of glucose in the blood vessel are changed in synchronization with each other, the concentration of glucose in the intracellular fluid and the concentration of glucose in the blood vessel are almost proportional to each other.

The glucose sensor 30 used in the present invention can use various known types of sensors.

As an example, the glucose sensor 30 may be implanted subcutaneously by surgery.

That is, the glucose sensor 30 may be placed under the subcutaneous implantation and inserted by a procedure.

The method for measuring the glucose concentration through the glucose sensor 30 used in the present invention can be a known electrochemical analysis method. The electrochemical analysis method is a method in which oxygen is consumed from glucose extracted by an enzyme electrode (not shown) To generate hydrogen peroxide, and oxidizing the produced hydrogen peroxide by an appropriate potential to measure the amount of generated electrons, thereby measuring the concentration of glucose.

However, the method of measuring the glucose concentration through the glucose sensor 30 is not limited to the above-described method. If the method is capable of measuring glucose on a concentrated region by being disposed in a region where glucose is concentrated by reverse- It can be variously modified.

Hereinafter, a blood glucose measurement method according to an embodiment of the present invention will be described in detail with reference to FIGS. 1 and 6. FIG.

The blood glucose measurement method according to the embodiment of the present invention includes the step of inserting the glucose sensor 30 into the electrode unit 20 while contacting the skin with the skin and / (S20), and measuring the concentration of glucose (S30) through the glucose sensor (30).

Hereinafter, each step will be described in more detail.

First, the glucose sensor 30 can be inserted in the direction of the (-) pole 21 while allowing the electrode unit 20 to contact the skin and / or subcutaneously. At this time, it is also possible to form the electrode unit 20 in the form of a semi-invasive or fully invasive needle and insert it into the skin layer (semi-invasive) or subcutaneous (complete invasion).

The glucose sensor 30 has an enzyme electrode (not shown) formed therein in the form of a fine needle and is inserted subcutaneously in the (-) pole 21 direction of the electrode unit 20 to directly measure the glucose concentration in the intercellular fluid Can be measured.

Thereafter, an electric current is applied through the electrode portion 20.

When an electric current is applied through the electrode unit 20, a current is applied to the transdermal interstitial fluid, so that a cation such as Na + in the intracellular fluid flows in the (-) pole 21 direction and an anion such as Cl- 22), and glucose in the interstitial fluid flows through the ion flow as it moves in the (-) pole 21 direction as shown by the arrow in Fig.

At this time, although the glucose itself does not become ionic, cations such as Na + migrate toward the (-) pole 21 together with the ion current moving in the (-) pole 21 direction.

The glucose concentration is measured through the glucose sensor 30 after the glucose concentration in the (-) pole 21 direction.

The concentration of glucose through the glucose sensor 30 can be measured by a known electrochemical analysis method. The electrochemical analysis method is a method in which glucose is caused to generate hydrogen peroxide by the glucose oxidase immobilized in the glucose sensor 30 and a constant voltage is applied to the generated hydrogen peroxide to measure the electric current, Can be measured.

In the conventional method, only the glucose naturally flows into a predetermined region of the electrode, so that it is difficult to ensure the accuracy of the measurement because the amount of glucose introduced into the periphery of the electrode is small. However, Since the method of forcibly collecting and concentrating glucose, the amount of glucose introduced into the vicinity of the electrode is large, and the accuracy of measurement is remarkably improved.

The measured glucose concentration is transmitted to the output device (not shown) including the receiver located outside the body via the transmitter 10, and it is possible to confirm the glucose concentration measured through the output device (not shown).

The glucose concentration continuously measured in a predetermined time unit can be stored in an output device (not shown), and it is possible to record and manage the glucose concentration for several days.

As described above, in the blood glucose measurement method according to the embodiment of the present invention, the glucose is concentrated in the (-) pole 21 direction due to the current applied through the electrode unit 20, Since the concentration of glucose is measured through the inserted glucose sensor 30, the measurement accuracy can be remarkably improved as compared with the conventional blood glucose measurement method.

As a result, the blood glucose measurement method using the invasive continuous blood glucose meter 100 and the blood glucose measurement method using the reverse ionization according to the present invention can be carried out by applying an electric current through the electrode unit 20, The concentration of glucose is measured through the glucose sensor 30 inserted in the (-) pole 21 direction, so that the measurement accuracy can be remarkably improved as compared with the conventional blood glucose meter 100 .

Furthermore, since the accurate glucose concentration can be measured even if the depth to which the glucose sensor 30 penetrates subcutaneously is made small, the foreign substance feeling can be remarkably lowered.

Hereinafter, the blood glucose meter 100 described above will be described in more detail with reference to FIG. 2 and FIG.

For example, the electrode unit 20 may be arranged at a predetermined position on the skin to apply a current to the body.

For example, the electrode portion 20 may be disposed on the epidermis of the skin, or may be inserted into the dermis, subcutaneous fat layer, or the like.

Here, the glucose sensor 30 (hereinafter, referred to as a sensor portion) may be a structure for penetrating subcutaneously to measure glucose.

The sensor unit 30 may directly measure the amount of glucose, but may also indirectly measure the amount of glucose by acquiring data and / or chemical changes that may be generated by contact with glucose.

For example, the electrode unit 20 may include a positive electrode 22 (hereinafter referred to as a positive electrode unit) and a negative electrode 21 (hereinafter referred to as a negative electrode unit) (+) Electrode portion 22 and the (-) electrode portion 21 may be spaced apart from each other by a predetermined distance, and may be disposed at a predetermined position of the skin.

The distance between the end of the sensor unit 30 subcutaneously subcutaneously and the (-) electrode unit 21 provided on the skin is determined by the distance between the end of the sensor unit 30 infiltrated subcutaneously, (+) Electrode portion 22 may be different.

3, the separation distance between the end (lower end) of the sensor unit 30 and the (-) electrode unit 21, which is subcutaneously placed at a predetermined position, The distance between the end of the sensor unit 30 (the lower end) and the (+) electrode unit 22 may be different.

The distance between the end of the sensor unit 30 and the negative electrode unit 21 may be smaller than the distance between the end of the sensor unit 30 and the positive electrode unit 22.

That is, the end portion of the sensor portion 30 may be disposed offset toward the (-) electrode portion 21 from the (+) electrode portion 22.

In addition, for example, the end of the sensor unit 30 may be disposed within a footprint A occupied by the (-) electrode unit 21.

(-) electrode unit 21 is disposed at a predetermined position on the skin, the lower side of the (-) electrode unit 21 is connected to the footprint of the (-) electrode unit 21, An end portion of the sensor unit 30 may be disposed within a footprint A defined by the (-) electrode unit 21.

As a result, the sensor unit 30 can be easily brought into contact with glucose guided to the (-) electrode unit 21.

The end of the sensor unit 30 described above may refer to a lower end of the sensor unit 30, but it may be formed of a material capable of reacting with glucose in the sensor unit 30, It may mean the end of the part.

Hereinafter, the positional relationship between the electrode unit 20 and the sensor unit 30 will be described in more detail with reference to FIG. 2 and FIG.

For example, the blood glucose meter 100 may further include a position regulating unit 40 for regulating the positional relationship between the electrode unit 20 and the sensor unit 30.

For example, the position regulating unit 40 may determine the positional relationship between the (-) electrode unit 21 and the (+) electrode unit 22, the positional relationship between the sensor unit 30 and the (+) electrode unit 22, And / or the positional relationship between the sensor unit 30 and the (-) electrode unit 21 may be defined.

The positional relationship refers to a positional relationship between the electrode unit 20 and the acid sensor unit 30 when the electrode unit 20 and the sensor unit 30 are installed on the human body, And so on.

That is, the electrode unit 20 is installed on the skin and fixed directly or indirectly to the skin. The sensor unit 30 is penetrated subcutaneously, and the maximum penetration state The positional relationship between the electrode unit 20 and the sensor unit 30 can be defined.

For example, the electrode unit 20 may be fixed at a predetermined position on the position defining unit 40.

For example, the (+) electrode portion 22 and / or the (-) electrode portion 21 may be fixed at a predetermined position on the position defining portion 40.

For example, the electrode unit 20 may be formed on the lower surface of the position defining unit 40 by a screen printing method, sputtering, or the like, or may be adhesively fixed by a mechanical coupling, an adhesive, or the like.

As a result, the electrode unit 20 can be fixed at a predetermined position on the lower side of the position defining unit 40.

In addition, the sensor unit 30 can be subcutaneously infiltrated at a predetermined position on the position defining unit 40. [

That is, the position regulating unit 40 may define the position at which the sensor unit 30 is subcutaneously infiltrated.

For example, the position regulating portion 40 may include an infiltration inducing portion for defining a position at which the sensor portion 30 penetrates subcutaneously. The sensor portion 30 may be subcutaneously penetrated through the infiltration inducing portion .

That is, the position regulating unit 40 may include the infiltration inducing unit that previously defines the position where the sensor unit 30 is subcutaneously infiltrated.

As a result, the position regulating portion 40 not only defines the position of the electrode portion 20 but also defines the position of the sensor portion 30 penetrating the subcutaneous body, and consequently, the electrode portion 20 The positional relationship between the sensor units 30 can be defined.

Here, for example, the infiltration inducing portion may be formed as a through space S.

That is, the infiltration inducing portion may be a space formed through a part of the position defining portion 40.

The penetration inducing portion may be formed between the positive electrode portion 22 and the negative electrode portion 21 and further may be formed to be inclined toward the negative electrode portion 21 toward the lower side, And may be formed as a through space (S).

The user can insert the sensor unit 30 subcutaneously through the infiltration inducing unit.

The infiltration inducing portion may be the penetrating space S but is not limited thereto and may be an identification mark distinguished from other portions of the position regulating portion 40. [

Here, the blood glucose meter 100 may be disposed on the through-hole S so that the sensor unit 30 and the position defining unit 40 are spaced apart from each other on the through-hole S, And a guide portion 50 for guiding the portion 30 to penetrate subcutaneously.

For example, the guide portion 50 is configured such that the sensor portion 30 disposed on the through space S and the position defining portion 40 defining the through space S are spaced apart from each other .

The guide part 50 is disposed on the through space S so that the sensor part 30 inserted into the through space S is guided by the guide can do.

For example, the guide portion 50 may be a pipe having a hollow shape.

The sensor unit 30 can be subcutaneously penetrated through the hollow formed by the guide unit 50.

For example, the guide portion 50 may be attached to the position regulating portion 40 or may have a material different from that of the position regulating portion 40.

The guide part 50 may be connected to the sensor part 30 and may be moved in conjunction with the sensor part 30.

Hereinafter, the blood glucose meter 100 and the blood glucose measurement method will be described in more detail with reference to FIG. 2 and FIG.

First, the user can install the position defining portion 40 on which the electrode portion 20 is mounted on the skin.

For example, the lower surface of the position regulating portion 40 facing the skin may be formed with an adhesive layer so as not to be separated from a predetermined position of the skin, or may be fixed to a predetermined position of the human body with a thermal member such as a band .

For example, the position defining portion 40 may be a pad having an adhesive layer formed on a lower surface thereof, or may be a case.

The user can fix the position regulating portion 40 at a predetermined position on the skin.

As a result, the (+) electrode unit 22 and the (-) electrode unit 21 can be fixed at a predetermined position of the skin by the position defining unit 40.

After the position regulating portion 40 and the electrode portion 20 are disposed at predetermined positions on the skin, the user can subcutaneously infiltrate the sensor portion 30.

At this time, the user can subcutaneously infiltrate the sensor unit 30 through the infiltration induction unit provided in the position defining unit 40. [

The extent to which the sensor unit 30 is subcutaneously infiltrated can be predetermined.

For example, the degree of penetration into the sensor unit 30 can be predetermined because the sensor unit 30 is in direct / indirect contact with the position defining unit 40 and / or the guide unit 50.

More specifically, when a user applies an external force to infiltrate the sensor unit 30, the user can infiltrate the sensor unit 30 to a predetermined degree, When an external force is applied to the sensor unit 30, the sensor unit 30 directly or indirectly contacts the sensor unit 30 with the position defining unit 40 and / or the guide unit 50, . &Lt; / RTI >

As a result, the position regulating portion 40 and / or the guide portion 50 not only define the positional relationship between the sensor portion 30 and the electrode portion 20, The degree of penetration into the subcutaneous tissue may be defined.

After the sensor unit 30 is inserted at a prescribed predetermined subcutaneous position, the electrode unit 20 may apply current to guide glucose to the (-) electrode unit 21 side.

Thereafter, the sensor unit 30 can measure blood glucose by reacting with glucose guided to the (-) electrode unit 21.

FIG. 4 is a diagram showing another embodiment of the blood glucose meter 100. FIG.

As shown in FIG. 4, the infiltration inducing portion may be formed on the footprint A defined by the (-) electrode portion A21.

That is, the infiltration inducing portion may be formed at a position where the infiltration inducing portion is surrounded by the (-) electrode portion A21 in at least one direction, and the sensor portion 30 penetrating subcutaneously through the infiltration inducing portion may be formed in the (- And can be disposed on the footprint A specified by the electrode section A21.

5 is a schematic block diagram of the configuration of the blood glucose meter 100. The blood glucose meter 100 includes the transmitter 10, the electrode unit 20, the sensor unit 30, and the controller 60 .

The control unit 60 is a configuration that implements control of current application of the electrode unit 20, calculation / calculation of data sensed by the sensor unit 30, and / or control of operation of the transmitter 10 .

For example, the transmitter 10, the electrode unit 20, the sensor unit 30, the controller 60, the position regulating unit 40, and the guide unit 50 May be configured such that at least one is mutually desorbed from the other.

For example, the electrode unit 20 may be detached from the position defining unit 40 to be replaced with a new electrode unit 20, and the guide unit 50 may be provided with the position defining unit 40, It may be removable.

In addition, for example, the position specifying unit 40 may be detached from the transmitter 10.

In addition, the electrode unit 20 is moved by an external force of the user and penetrates subcutaneously through the penetration inducing unit. However, the electrode unit 20 is not limited to the electrode unit 20, And may be used by the user in a state in which it is disposed at a predetermined position on the position defining portion 40.

That is, when the user sets the position regulating portion 40 on the skin, the electrode portion 20 fixed to the position regulating portion 40 is provided on the skin and fixed to the position regulating portion 40 The sensor unit 30 may be subcutaneously infiltrated.

Although the above-described blood glucose meter 10 has been described for the purpose of measuring blood glucose, the technical idea of the present invention is not limited to the use of blood glucose measurement. It can also be used for other purposes.

That is, those skilled in the art will appreciate that the technical idea of the present invention can be modified for other uses.

While the present invention has been described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the disclosed exemplary embodiments, but, on the contrary, It will be apparent to those skilled in the art that changes or modifications may fall within the scope of the appended claims.

Claims

A blood glucose meter installed on the skin for measuring blood glucose,

An electrode unit disposed at a predetermined position of the skin to apply a current to the body; And

And a sensor portion penetrating into the subcutaneous tissue and measuring glucose,

The electrode unit includes:

(+) Electrode portion and (-) electrode portion,

The distance between the end of the sensor part and the (-

A distance between the end of the sensor part and the (+) electrode part,

Blood glucose meter.
The method according to claim 1,

And a position regulating portion that defines a positional relationship between the electrode portion and the sensor portion,

Blood glucose meter.
3. The method of claim 2,

The electrode unit includes:

And a fixing member fixed at a predetermined position on the position defining portion,

The sensor unit includes:

Wherein the positioning portion penetrates subcutaneously at a predetermined position on the position regulating portion,

Blood glucose meter.
The method of claim 3,

The position specifying unit

And an infiltration inducing portion for defining a position at which the sensor portion is subcutaneously infiltrated,

The sensor unit includes:

And penetrating subcutaneously through the penetration inducing portion,

Blood glucose meter.
5. The method of claim 4,

The infiltration inducing portion

Which is formed as a through space,

Blood glucose meter.
6. The method of claim 5,

And a guide portion disposed on the through space to guide the sensor portion and the position defining portion to be spaced apart from each other on the through space and to guide the sensor portion to be subcutaneously penetrated,

Blood glucose meter.
The method according to claim 1,

The distance between the end of the sensor part and the (-

A distance between the end of the sensor portion and the (+) electrode portion,

Blood glucose meter.
8. The method of claim 7,

The end of the sensor unit

Wherein the (-) electrode portion is disposed within a footprint occupied by the (-) electrode portion,

Blood glucose meter.
A blood glucose measurement method for measuring blood glucose using the blood glucose meter according to any one of claims 1 to 8.