WO2014010790A1 - Method for measuring blood glucose level and blood glucose level measurement system and device using same - Google Patents

Description

Blood glucose measurement method and blood glucose measurement system and apparatus using same

The present invention relates to a blood glucose measurement method and a blood glucose measurement system and apparatus using the same.

The blood glucose level refers to the amount of glucose in the blood. Humans are generally known to be in the range of 4 mmol / Liter or 72 mg / dL, but this value changes according to human metabolism during the day. That is, the general human blood glucose concentration is in the range of 70 to 130 mg / dL before meals and 180 mg / dL after meals. Cases exceeding this range are classified as hyperglycemia, and cases below the normal range are classified as hypoglycemia. In general, hyperglycemia may be due to diabetes, the possibility of progression to diabetes or a condition that has not yet found diabetes, hyperglycemia is highly associated with diabetes.

Blood glucose measurement is a method of measuring blood collection. The blood sampling method is a method of measuring blood glucose levels in blood by analyzing a fingertip and the like by stabbing a sterilized needle. Another method of measuring blood glucose level is electrophoresis. In the electrophoresis method, after the electrode is attached to the skin and the patch is applied, glucose in the blood is extracted through the skin and penetrated into the gel formed in the patch. Glucose penetrated into the gel undergoes a chemical reaction with glucose oxidase in the gel during electrophoresis to oxidize to form a predetermined current, which can be measured to calculate blood glucose levels.

Blood sampling is a one-off method and cannot be applied to patients who require continuous blood glucose monitoring. In addition, a diabetic patient has a problem that the blood glucose level cannot be measured by using a blood collection method four or more times a day since the wound is slow and there is a risk of complications. Even in non-diabetic patients, there is a heavy burden on blood glucose measurement by blood collection method because of fear of blood collection by wounding fingertips.

In the case of electrophoresis, the glucose oxidase in the patch may decay due to reaction with air, and the activity of the oxidase is changed according to conditions such as ambient temperature and pH, so the accuracy of the measurement is problematic. Furthermore, since glucose in the blood must be extracted above the skin, skin rashes such as spots appear on the extracted glucose portion.

The present invention is to solve the above problems of the prior art, it is one of the objects of the present invention to provide a blood glucose measurement method and blood glucose measurement system and apparatus that can measure the blood glucose level without a deep wound and rash.

It is another object of the present invention to provide a blood glucose measurement method capable of continuous blood glucose monitoring and a blood glucose measurement system and apparatus using the same.

It is another object of the present invention to provide a blood glucose measurement method which is not influenced by or less affected by the surrounding environment, and a blood glucose measurement system and apparatus using the same.

A blood glucose meter according to the present invention includes a plurality of needles including at least one needle having a micropore structure layer formed on a surface thereof and invading within a subcutaneous pain depth, and electrically connected to the plurality of needles within the depth of the hypodermic pain point. And a processor unit (microprocessor) for calculating a blood glucose level in the blood by calculating a relationship between the voltage source applying a constant voltage and the current formed by the applied voltage and the applied voltage.

In one embodiment, the needle is formed of at least one of gold, Au, silver, Ag, stainless steel, and carbon, and the microporous structure layer is platinum , Pt).

In one embodiment, the micropores have a diameter of 1nm to 10nm, the microporous structure layer has a thickness of 50nm to 1000nm.

In one embodiment, the needle invades subcutaneously 2 mm to 5 mm deep.

In one embodiment, the surface of the needle is further formed with a glucose selective layer capable of selectively permeating glucose.

In one embodiment, the glucose selective layer comprises at least one of nafion, cyclodextrin (Cyclodextrine).

In one embodiment, the surface of the needle is further formed with an anti-immune substance layer to suppress the human immune mechanism.

In one embodiment, the anti-immune material layer includes at least one of polychlorotrifluoroethylene (PCTFE, Kel-F), nafion, and 2-methacryloyloxyethyl phosphorylcholine (MPC).

In one embodiment, the constant voltage is at least one of a direct current voltage and an alternating voltage.

In one embodiment, the alternating voltage has a frequency greater than 0 and 0.1 MHz.

In one embodiment, the constant voltage is a voltage value greater than 0 and less than 1V relative to the reference electrode.

In one embodiment, the constant voltage is a voltage value greater than 0 and less than 1V relative to the reference electrode.

In one embodiment, the processor unit detects a current value with respect to an applied voltage and performs a calculation using a current-voltage relationship to obtain a blood glucose level.

In one embodiment, the blood glucose meter further includes a communication unit for communicating the calculated blood sugar value with an external terminal in a wired or wireless manner.

The blood glucose measurement method according to the present invention comprises invading a plurality of needles including at least one needle having a microporous structure layer within a subcutaneous pain point depth, a first electrode connected to at least one of the plurality of needles, and Applying a constant voltage to a second electrode connected to at least one needle, and calculating a current-voltage relationship according to the applied voltage to calculate a blood glucose level in blood.

In one embodiment, the step of invading the needle subcutaneously is performed by invading the needle to subcutaneous 2mm to 5mm.

In one embodiment, the applying of the constant voltage is performed by applying at least one of a DC voltage and an AC voltage.

In one embodiment, applying the AC voltage is performed by applying an AC voltage whose frequency is greater than 0 and within 0.1 MHz.

In one embodiment, the step of applying the constant voltage is performed by applying a voltage value of more than 0 and less than 1V relative to the reference electrode.

In one embodiment, the calculating of the blood glucose level may be performed by calculating a blood glucose level by calculating a resistance value when a DC voltage is applied and an impedance value when an AC voltage is applied.

In one embodiment, the method further comprises transmitting the calculated blood glucose level by wire or wirelessly.

The blood glucose measurement system according to the present invention includes a plurality of needles having a micropore structure layer, a glucose selective layer, and an anti-immune substance layer formed on the surface and invading within a subcutaneous puncture depth, and a constant voltage subcutaneously through the plurality of needles. Transmitting the blood glucose meter and the blood glucose meter including a microprocessor for calculating a blood glucose level in the blood by calculating a voltage source to be applied, a current-voltage relationship according to the applied voltage, and a communication unit configured to transmit the calculated blood sugar level to the outside. A communication unit for receiving a blood sugar value, a processor unit for processing the received blood sugar value, and a terminal for displaying a display for displaying the processed blood sugar value.

In one embodiment, the communication unit of the blood sugar meter and the communication unit of the terminal communicates by wire or wirelessly.

In one embodiment, the wireless communication is a Shared Wireless Access Protocol (SWAP), Bluetooth, Infrared Data Association (IrDA), Zigbee, Wifi, Near Field Communication (NFC), Cellular (cellular) And Long Term Evolution (LTE) communication protocol.

According to the present invention, since the needle of the blood glucose meter invades within the depth of the subcutaneous pain point, the blood glucose level can be measured without inflicting a deep wound and psychological burden on the measurer.

According to the present invention, since glucose is not extracted over the skin, blood glucose can be measured without problems such as skin rash.

According to the present invention, the effect that continuous blood glucose monitoring is possible is provided.

According to the present invention, there is provided an advantage that blood glucose can be measured without being affected by changes in the surrounding environment.

1 and 2 are schematic views showing an outline of a blood glucose meter and a blood sugar measuring system according to an embodiment of the present invention, respectively.

3 is a flowchart illustrating a procedure of a blood glucose measurement method according to an embodiment of the present invention.

Description of the present invention is only an embodiment for structural or functional description, the scope of the present invention should not be construed as limited by the embodiments described in the text. That is, since the embodiments may be variously modified and may have various forms, the scope of the present invention should be understood to include equivalents capable of realizing the technical idea.

On the other hand, the meaning of the terms described in the present application should be understood as follows.

Terms such as "first" and "second" are intended to distinguish one component from another component, and the scope of rights should not be limited by these terms. For example, the first component may be named a second component, and similarly, the second component may also be named a first component.

When a component is referred to as being "above" or "on" another component, it should be understood that another component may be present, although it may be directly above the other component. On the other hand, when a component is said to be "in contact" with another component, it should be understood that there is no other component in between. On the other hand, other expressions describing the relationship between the components, such as "between" and "immediately through", "between" and "immediately between" or "neighboring to" and "on" Direct neighbor "and so on.

* A singular expression should be understood to include a plurality of expressions unless the context clearly indicates otherwise, and the terms "comprise" or "having" should refer to the features, numbers, steps, operations, components, parts or parts described. It is to be understood that combinations of these are intended to be present and do not preclude the existence or addition of one or more other features or numbers, steps, operations, components, parts or combinations thereof in advance.

Each step may occur differently from the stated order unless the context clearly dictates the specific order. That is, each step may occur in the same order as specified, may be performed substantially simultaneously, or may be performed in the reverse order.

The drawings referred to for describing the embodiments of the present disclosure are intentionally exaggerated in size, height, thickness, etc. for ease of explanation and easy understanding, and are not to be enlarged or reduced in proportion. In addition, any component illustrated in the drawings may be intentionally reduced in size, and other components may be intentionally enlarged in size.

All terms used herein have the same meaning as commonly understood by one of ordinary skill in the art unless otherwise defined. Terms such as those defined in the commonly used dictionaries should be construed to be consistent with the meanings in the context of the related art and should not be construed as having ideal or overly formal meanings unless expressly defined in this application. .

Hereinafter, a blood glucose meter according to an embodiment of the present invention will be described with reference to the accompanying drawings. 1 is a view for explaining the outline of the blood glucose meter and blood glucose measurement system according to an embodiment of the present invention. Referring to FIG. 1, a blood glucose meter according to an embodiment of the present invention includes a voltage source 200 for applying a constant voltage between a plurality of needles 100a and 100b and a plurality of needles that invade within a depth where a hypodermic pain point is located. And a processor unit 300 that calculates a blood glucose level in the blood by calculating a current-voltage relationship according to the voltage.

According to an embodiment of the blood glucose meter according to the present invention, a surface of at least one of the plurality of needles 100a may include a micro pore structured layer 110, a glucose selective layer 130, and an anti-immune material layer ( 140 is formed. If glucose is in contact with the surface of the needle 100a in which the microporous structure layer is formed among the needles invading the skin, it is oxidized and cationic. As will be described later, in one embodiment, when the voltage source applies a direct current voltage, as shown, the microporous structure layer may not be formed on the surface of the needle 100b electrically connected to the electrode to which glucose is reduced. Alternatively, although not shown, the microporous structure layer may be formed on the surface of the needle 100b electrically connected to the electrode to which glucose is reduced. In another embodiment, which will be described later, when the voltage source applies an alternating voltage, it forms a microporous structure layer on the surface of all of the needles that have invaded the skin. The alternating current is alternating in polarity at regular intervals, so oxidation and reduction of glucose occur over time in the same needle.

In one embodiment, the microporous structure layer 110 is formed of platinum (Pt). In one example, the microporous structure layer 110 is formed by arranging holes of 1 nm to 10 nm. In one example, the thickness of the microporous structure layer 110 is formed to a thickness of 50nm to 1000nm. As the thickness of the microporous structure layer 110 becomes thinner, the selectivity of glucose is lowered, and as the thickness becomes thicker, pores are not sufficiently formed. The method of forming such a microporous structure layer has been disclosed through various papers and patents, and is omitted herein for simplicity of description.

In one embodiment, the body 120 of the needle is infiltrated under the skin s and is formed of an acid resistant material to prevent corrosion by blood. In one example, the body 110 of the needle is formed of a metal such as gold (Au), silver (Ag), stainless steel (stainless steel). In another example, the body 120 of the needle is formed of carbon (carbon, C). The needle invades to the depth where the subcutaneous pain spot is located. Therefore, since the stimulus to pain points can be minimized, the pain that the measurer feels when the blood glucose meter according to the present invention is used on the skin is small. In one embodiment, the needles 100a and 100b invade subcutaneously 2 mm to 5 mm deep.

As described above, the microporous structure layer 110 contacts glucose released from the capillary c to oxidize glucose. That is, the glucose (glucose) flowing out from the subcutaneous capillary (c) is in contact with the microporous structure layer 120 is oxidized to a cation state.

In one embodiment, a glucose selective layer 130 is located on the surface of the microporous structure layer 110. In addition to glucose, there are components such as electrolytes, nutrients, vitamins, hormones, etc. in the blood to which the needles 100a and 100b are in direct contact. Therefore, if another substance in the blood is in contact with the microporous structure layer 110 to cause a chemical reaction, the exact blood glucose value cannot be measured. Therefore, glucose in the blood is selectively transmitted to contact the microporous structure layer 110 thereunder. A glucose selective layer 130 is formed on top of the microporous structure layer 110 so as to enable it. This configuration can increase glucose selectivity and improve the accuracy of blood glucose measurements. For example, the glucose selective layer 130 is formed of a polymer. For example, the glucose selective layer 130 is formed using nafion and cyclodextrine. Those skilled in the art having ordinary skill in the art will appreciate that the size of glucose shown in FIG. 1 is exaggerated compared to its actual size. It should be noted that this is purely for quick and easy understanding.

In one embodiment, the anti-immune material layer 140 is formed on the surfaces of the needles 100a and 100b. In general, since the needles 100a and 100b are made of a metal material, when a measurer who is continuously measuring blood glucose has a blood glucose meter according to the present invention for a long time, the immune mechanisms of the human body are infiltrated into the needles 100a and 100b. This operation may be a reaction such as inflammation. Therefore, the anti-immune substance layer 140 is formed on the surface of the needle in order to minimize side effects on the human body without operating the human immune mechanism for the needle. For example, the anti-immune material layer 140 is formed of at least one of polychlorotrifluoroethylene (PCTFE, Kel-F), nafion, and 2-methacryloyloxyethyl phosphorylcholine (MPC).

In one embodiment, the glucose selective layer 130 and the anti-immune material layer 140 are formed on the surfaces of the needles 100a and 100b using a coating method. For example, the method of coating the glucose selective layer 130 and the anti-immune material layer 140 may be formed using dip coating, spin coating, or drop coating. .

The voltage source 200 is electrically connected to the needle to apply a constant voltage to the skin tissue in which the needle is invaded. In one example, the voltage source 200 applies a voltage of any one type of a direct current (DC) voltage, an alternating current (AC) voltage, or a voltage in which the direct current voltage and the alternating voltage overlap. As described above, when the voltage source 200 applies the DC voltage, as shown in FIG. 2, the microporous structure layer may not be formed on the needle 100b connected to the electrode to which glucose is reduced. In another example, when the voltage source 200 applies a DC voltage, the microporous structure layer may be formed on the needle 100b connected to the electrode to which glucose is reduced. In another embodiment, when the voltage source 200 applies an alternating voltage, the microporous structure layer is formed on all of the needles.

In one example, the magnitude of the voltage applied by the voltage source 200 is greater than 0 and less than 1V relative to the reference electrode (Ag, AgCl is used as the reference electrode). If it exceeds 1 V, the oxidation / reduction process of other substances in the blood is more dominant than the glucose oxidation process, so that the amount of glucose in the blood cannot be accurately measured. Since the voltage value applied through the needle 100a and the needle 100b is a voltage value suitable for oxidizing only glucose in the blood, it is possible to prevent other substances in the blood from ionizing and participating in the current component. Therefore, more accurate blood glucose value can be obtained. In one example, the frequency is greater than 0 and less than or equal to 0.1 MHz when an alternating voltage is applied.

In this way, when the voltage is applied, the ionized glucose moves from the + potential to the-potential direction by the applied voltage to form a current and is reduced at the electrode having the-potential. It can be seen that the more glucose in the blood, the greater the amount of ionized glucose, the higher the current value. Therefore, the blood glucose level can be calculated by measuring the amount of current flowing when a constant voltage is applied to the needle invading the skin.

The processor unit 300 calculates a blood glucose level by sensing a current according to a voltage applied by the voltage source 200 and calculating a current-voltage relationship. That is, the blood glucose level may be calculated by detecting a current value corresponding to the applied voltage and performing an operation using the same. In one embodiment, the processor unit 300 includes an analog digital converter (ADC) 310, an operation unit 320, a memory 330, and a control unit 340. The controller 340 controls the ADC 310 to receive a current value and convert it to a digital value. The controller 340 calculates a voltage-current relationship by using the digital current value output from the ADC 310 by the calculator 320 and the voltage value output by the power supply 200, and outputs a blood sugar value corresponding to the calculation result. The operation unit 320 is controlled to control. In one embodiment, the controller 340 stores the calculated blood glucose value in the memory 330.

In one embodiment, the communication unit 400 transmits the blood sugar value stored in the memory 330 to the external terminal 500 by wire or wireless communication. As an example, the communication unit 400 may include an external terminal 500, a shared wireless access protocol (SWAP), a Bluetooth, an Infrared Data Association (IrDA), a Zigbee, a Wifi, and a Near Field Communication. ) Using cellular and long term evolution (LTE) communication protocols. In another embodiment, the external blood glucose value transmitted through the blood glucose meter communication unit 400 may be transmitted by the external terminal 500, and the blood sugar value may be displayed through the display unit 510 formed in the external terminal 500. At the same time, it can also be displayed as a line graph that can detect the change in blood glucose value over time.

In another embodiment, referring to FIG. 2, the display unit 600 may be positioned on the surface of the blood glucose meter so that a measurer may easily check blood sugar. Similarly, the blood sugar value displayed on the display unit 600 may be displayed in Arabic numerals, and at the same time, the blood sugar value may be displayed as a line graph that can identify a change in blood sugar value over time.

Referring to Figure 3 describes a blood glucose measurement method according to an embodiment of the present invention. 3 is a flowchart illustrating a blood glucose measurement method according to an embodiment of the present invention. Referring to FIG. 3, a plurality of needles including at least one needle having a microporous structure layer are invaded within a subcutaneous pain point depth (S100). Glucose contacts the microporous structure layer formed on the surface of the infiltrated needle and is oxidized to cationize. The microporous structure layer is formed of platinum as described above, and in one example, the microporous structure layer 110 is formed by arranging holes of 1 nm to 10 nm. In one example, the thickness of the microporous structure layer 110 is formed to a thickness of 50nm to 1000nm. The body 110 of the needle is formed of a metal such as gold, Au, silver, Ag, stainless steel, for example, and in another example, the body 110 of the needle is formed of carbon ( carbon, C). The needle invades subcutaneously 2 mm to 5 mm deep, for example.

A constant voltage is applied to the first electrode connected to at least one of the plurality of needles and the second electrode connected to the other at least one needle by using the voltage source (S200). In one example, the voltage source applies the voltage in any one form of a direct current (DC) voltage, an alternating current (AC) voltage, or a voltage in which the direct current voltage and the alternating voltage overlap. In one example, the magnitude of the voltage to which the voltage source is applied is greater than 0 and within 1 V relative to the reference electrode. This is to prevent this because the application of a voltage exceeding the above-mentioned range is ionized by a substance other than glucose in the blood to participate in the current component. In one example, the frequency is greater than 0 and less than or equal to 0.1 MHz when an alternating voltage is applied.

The processor unit calculates a blood sugar level in the blood by calculating a current-voltage relationship according to the applied voltage (S300). In one embodiment, after detecting the current value according to the voltage applied by the voltage source, it is converted into a digital value. The processor outputs a blood sugar value corresponding to the calculation result by performing a calculation process using the current value and the voltage value output from the ADC. In one embodiment, this operation is implemented in hardware. In another embodiment, the operation is implemented in software. In one embodiment, the blood glucose value derived from the calculation is stored in the memory. In one embodiment, the communication unit transmits the blood sugar value calculated by the processor unit or stored in the memory to an external terminal (not shown) by wire or wireless communication. As an example, the communication unit communicates with an external terminal by wire or wirelessly. In another embodiment, the display unit is located on the surface of the blood glucose meter, the processor unit calculates, or receives the blood glucose value stored in the memory to display it. In one example, the blood sugar value displayed on the display unit may be displayed in Arabic numerals, and at the same time, it may also be displayed as a line graph that can detect a change in blood sugar value over time.

Since the needles 100a and 100b formed in the blood glucose meter according to the present invention invade to a depth just before the depth of the subcutaneous pain point (pain spot) is located, the amount of bleeding is small and the pain and burden felt by the measurer are less than that of the blood collection method.

In addition, since the present invention does not use enzymes to oxidize glucose, it can be freely used from environmental conditions such as enzyme decay, temperature, and pH.

Although described with reference to the embodiments shown in the drawings to aid the understanding of the present invention, this is an embodiment for the implementation, it is merely exemplary, those skilled in the art from various modifications and equivalents therefrom It will be appreciated that other embodiments are possible. Therefore, the true technical protection scope of the present invention will be defined by the appended claims.

Claims (23)

A plurality of needles including at least one needle having a micropore structure layer formed on the surface and invading within a subcutaneous pain point depth; A voltage source electrically connected to the plurality of needles to apply a constant voltage within the depth of the hypodermic point; And And a microprocessor for calculating a relationship between the current formed by the applied voltage and the applied voltage to calculate a blood glucose level in blood. The method of claim 1, The needle is formed of at least one of gold, Au, silver, Ag, stainless steel, and carbon. The microporous structure layer is a blood glucose meter formed of platinum (platinum, Pt). According to claim 1, wherein the micropores have a diameter of 1nm to 10nm, The microporous structure layer has a thickness of 50nm to 1000nm. The blood glucose meter of claim 1, wherein the needle invades subcutaneously 2 mm to 5 mm deep. The blood glucose meter of claim 1, wherein a glucose selection layer is further formed on a surface of the needle to selectively transmit glucose. The blood glucose meter of claim 5, wherein the glucose selective layer comprises at least one of nafion and cyclodextrine. The blood stage of claim 1, wherein an anti-immune substance layer is further formed on a surface of the needle to suppress human immune mechanisms. The blood glucose meter of claim 7, wherein the anti-immune substance layer comprises at least one of polychlorotrifluoroethylene (PCTFE, Kel-F), nafion, and 2-methacryloyloxyethyl phosphorylcholine (MPC). The blood glucose meter of claim 1, wherein the constant voltage is at least one of a direct current voltage and an alternating voltage. The blood glucose meter of claim 9, wherein the AC voltage has a frequency greater than 0 and 0.1 MHz. The blood glucose meter of claim 1, wherein the constant voltage is a voltage value greater than 0 and less than 1 V relative to a reference electrode. The blood glucose meter of claim 1, wherein the processor unit detects a current value with respect to an applied voltage and performs a calculation using a current-voltage relationship to obtain a blood sugar level. The blood glucose meter of claim 1, wherein the blood glucose meter further comprises a communication unit configured to communicate the calculated blood sugar value with an external terminal in a wired or wireless manner. Invading the plurality of needles including at least one needle having a microporous structure layer within a subcutaneous pain point depth, Applying a voltage to a voltage source connected to at least one of the plurality of needles and at least one of the needles on which the microporous structure layer is formed; And Calculating a blood sugar level in blood by calculating a current-voltage relationship according to the applied voltage. The method of claim 14, wherein the invading the needle subcutaneously is performed by invading the needle subcutaneously to 2 mm to 5 mm. The method of claim 14, wherein the applying of the voltage is performed by applying at least one of a DC voltage and an AC voltage. The method of claim 16, wherein the applying of the alternating voltage is performed by applying an alternating voltage having a frequency greater than 0 and within 0.1 MHz. The method of claim 14, wherein the applying of the constant voltage is performed by applying a voltage value greater than 0 and less than 1 V relative to the reference electrode. The method of claim 14, wherein the calculating of the blood glucose level comprises calculating a blood glucose level by calculating a resistance value when a DC voltage is applied and an impedance value when an AC voltage is applied. The method of claim 14, further comprising transmitting the calculated blood glucose level by wire or wirelessly. A micropore structure layer, a glucose selective layer, and an anti-immune substance layer formed on the surface and infiltrating within a subcutaneous puncture depth, a voltage source for applying a constant voltage subcutaneously through the plurality of needles, and A blood glucose meter including a processor configured to calculate a current-voltage relationship according to a voltage to calculate a blood glucose level in the blood, and a communication unit configured to transmit the calculated blood glucose amount to an outside; And And a communication unit for receiving a blood sugar value transmitted by the blood glucose meter, a processor unit for processing the received blood sugar value, and a terminal for displaying a display for displaying the processed blood sugar value. The blood glucose measurement system of claim 21, wherein the communication unit of the blood glucose meter and the communication unit of the terminal communicate by wire or wirelessly. 23. The wireless communication method of claim 22, wherein the wireless communication includes a shared wireless access protocol (SWAP), a Bluetooth, an Infrared Data Association (IrDA), a Zigbee, a Wifi, a Near Field Communication (NFC), and a cellular. And a blood glucose measurement system using any one of the Long Term Evolution (LTE) communication protocol.

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