Method for measuring glycation of red blood cells using physical and electrical characteristics and measuring glycated hemoglobin values ​​using the same, and an apparatus for performing the same

Abstract

The present invention relates to a method for measuring the concentration of glycated A1c hemoglobin, and the measuring device for glycated hemoglobin according to the present invention includes an inlet for receiving collected blood, a microchannel having a predetermined width so that red blood cells in the blood flowing into the inlet pass through individually, an outlet for discharging the red blood cells that have passed through the microchannel, and a plurality of electrode units formed in contact with the microchannel between the inlet and the outlet, the electrode units including a plurality of electrodes arranged at predetermined intervals along the passing direction of the red blood cells passing through the microchannel. According to the present invention, the degree of hardness of glycated red blood cells can be calculated from the time it takes to pass through the microchannel, making it easier to determine the degree of hardness without chemical measuring equipment.

Description

[Technical Field]

[0001] The present invention relates to a method for measuring the concentration of glycated A1c hemoglobin. [Background technology]

[0002] The blood glucose test commonly used to diagnose diabetes measures the amount of glucose in the blood as blood glucose level, but blood glucose level is a temporary value that can change before and after meals and due to other factors.

[0003] In contrast, the glycosylated hemoglobin test determines the degree to which glucose is bound to hemoglobin in red blood cells. Red blood cells bind to the sugar in the blood while they are in the blood, and by measuring the glycosylated hemoglobin value, it is possible to understand the blood glucose level accumulated over the average lifespan of a red blood cell, which is three months. Therefore, it is less affected by exercise status and food intake than blood sugar tests, which are affected by exercise status and food intake.

[0004] In other words, the glycated hemoglobin value is a more stable value than blood glucose level and can be used as a criterion for diagnosing diabetes. High glycated hemoglobin values ​​cause red blood cells to coagulate relatively more, which directly causes diabetic complications due to increased blood viscosity.

[0005] However, most existing glycosylated hemoglobin measuring devices are only available at hospitals and laboratories, using specific technology and equipment. While continuous monitoring of glycosylated hemoglobin is necessary to manage diabetes levels and the associated prognosis, methods for patients to monitor their own levels have been very limited in recent years. Similar to the widespread adoption of home blood glucose measuring devices, various methods have recently been developed to measure glycosylated hemoglobin directly at home without visiting a hospital (Korean Patent Registration Publication KR2281500 (Registration Date: July 20, 2021)). However, these methods are all based on biochemical methods, which have drawbacks such as limited device lifespans, complicated storage methods, and low measurement accuracy depending on storage conditions and the user's level of proficiency. Summary of the Invention [Problem to be solved by the invention]

[0006] The present invention aims to propose a method for determining glycosylated hemoglobin values.

[0007] More specifically, the present invention relates to the development of a home-use glycated hemoglobin measuring device that utilizes microchannel fabrication technology. More specifically, the present invention aims to propose a method for determining the degree of glycation by measuring changes in the physical properties of glycated red blood cells. [Means for solving the problem]

[0008] The glycosylated hemoglobin measuring device according to the present invention, which solves the above technical problems, comprises an inlet through which collected blood flows, a microchannel having a predetermined width so that red blood cells in the blood that flows into the inlet pass through individually, an outlet through which red blood cells that have passed through the microchannel are discharged, and a plurality of electrode units formed in contact with the microchannel between the inlet and the outlet, wherein the electrode units comprise a plurality of electrodes arranged at predetermined intervals along the direction in which the red blood cells pass through the microchannel.

[0009] The electrode section is preferably composed of a first electrode section on the inlet side and a second electrode section on the outlet side, and the impedance between at least one pair of electrodes in the first electrode section and the impedance between at least one pair of electrodes in the second electrode section change due to the passage of the red blood cells.

[0010] It is preferable that the first and second electrode units each consist of three consecutive electrodes, and that the electrical equilibrium state of the first impedance and the second impedance formed between two consecutive electrodes of the first electrode unit and the third impedance and the fourth impedance formed between two consecutive electrodes of the second electrode unit changes with the passage of the red blood cells.

[0011] The device includes a time measurement unit that measures the time taken for red blood cells in the blood to pass through the microchannel by using the difference between the time taken for the impedance value to change due to the passage of the red blood cells in the blood at a first point on the microchannel formed in contact with the electrode unit between the blood inlet and the outlet and the time taken for the impedance value to change at a second point on the microchannel, and a glycated hemoglobin value calculation unit that determines the degree of glycation of the red blood cells in the blood from the measured time.

[0012] It is preferable that the electrode unit is composed of a first electrode unit on the inlet side and a second electrode unit on the outlet side, and the time measurement unit calculates the transit time of the red blood cells through the microchannel from the difference between the time of change in the impedance value of the first electrode unit and the time of change in the impedance value of the second electrode unit.

[0013] It is preferable that the first and second electrode units are composed of a plurality of electrodes, and the time measurement unit calculates the transit time through the microchannel using the difference between the time period during which the impedance value changes due to the red blood cell being positioned between at least one pair of electrodes in the first electrode unit and the time period during which the impedance value changes due to the red blood cell being positioned between at least one pair of electrodes in the second electrode unit.

[0014] The glycosylated hemoglobin value calculation unit preferably calculates the degree of glycation of the blood using a proportional relationship between the transit time through the microchannel and the glycation of red blood cells in the blood.

[0015] The blood glycation level correcting unit may further include a glycated hemoglobin value correcting unit for correcting the blood glycation level using a user's reference glycated hemoglobin value.

[0016] To solve the above technical problem, the method for measuring glycated hemoglobin according to the present invention includes the steps of measuring the time of change in impedance value due to the passage of red blood cells in the blood at a first point on a flow path formed in contact with an electrode unit between a blood inlet and an outlet, measuring the time of change in impedance value at a second point on the micro flow path, measuring the flow path transit time using the difference between the measured first impedance change time at the first point and the measured second impedance change time at the second point, and calculating the glycated hemoglobin value based on the measured flow path transit time.

[0017] It is preferable that the first point is determined as at least one position on the area where the first electrode portion on the inlet side and the flow path contact, and the second point is determined as at least one position on the area where the second electrode portion on the outlet side and the flow path contact.

[0018] The first or second impedance change time is preferably measured based on a change in impedance value caused by red blood cells passing through the microchannel being positioned between a pair of electrodes in the first or second electrode unit.

[0019] The step of calculating the glycated hemoglobin value preferably calculates the degree of glycation of the blood using a proportional relationship between the time of passage through the microchannel and the glycation of red blood cells in the blood.

[0020] The method further includes correcting the calculated blood glycation level using a user's reference glycated hemoglobin value.

[0021] It is preferable that the first and second electrode units each consist of three consecutive electrodes, and the step of measuring the transit time through the microchannel includes measuring a change in impedance value using a change in the electrical equilibrium state of the first impedance and the second impedance formed between two consecutive electrodes of the first electrode unit and the third impedance and the fourth impedance formed between two consecutive electrodes of the second electrode unit, and calculating the transit time through the microchannel using the time of change in the impedance value. [Effects of the Invention]

[0022] According to the present invention, the degree of glycation can be easily measured by using the changes in the physical properties of red blood cells that accompany the glycation of the red blood cells.

[0023] In addition, by calculating the degree of hardness of each individual red blood cell from the time it takes to pass through a fine channel, the degree of glycation can be determined more stably against external and human factors than measurement equipment using biochemical techniques.

[0024] Furthermore, the present invention uses a simple circuit configuration to recognize minute electrical changes that occur when red blood cells pass through, thereby making it possible to determine the degree of glycation of red blood cells.

[0025] Furthermore, the present invention can be directly utilized in clinical diagnosis by correcting the measured glycated hemoglobin values ​​using individual reference values.

[0026] Furthermore, the present invention allows for the popularization of a measuring device as a home measuring device due to its miniaturization. [Brief explanation of the drawings]

[0027] [Figure 1] 1 is a diagram showing the structure of an apparatus for determining glycosylated hemoglobin values ​​according to the present invention; [Figure 2] 1 is a diagram showing the microchannel structure and principle of the device for determining glycated hemoglobin values ​​according to the present invention; [Figure 3]FIG. 1 shows an electrical structure for determining the physical value of red blood cells according to the present invention. [Figure 4] FIG. 1 shows an electrical structure for determining the physical value of red blood cells according to the present invention. [Figure 5] FIG. 1 shows an electrical structure for determining the physical value of red blood cells according to the present invention. [Figure 6] 1 is a diagram showing the structure of an apparatus for determining glycosylated hemoglobin values ​​according to the present invention; [Figure 7] 1 is a diagram showing the configuration of a device for determining a glycated hemoglobin value according to the present invention. [Figure 8] FIG. 1 is a diagram showing the flow of a method for determining a glycated hemoglobin value according to the present invention. [Figure 9] FIG. 10 is a diagram showing an example of patient data for managing glycosylated hemoglobin values ​​according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0028] The following merely illustrates the principles of the invention. Thus, those skilled in the art will be able to invent various devices that embody the principles of the invention and are within the concept and scope of the invention, although not explicitly described or shown herein. Furthermore, all conditional terms and embodiments listed herein are expressly intended, in principle, solely for the purpose of enabling the concept of the invention to be understood, and are not limiting to the embodiments and conditions so specifically listed.

[0029] The above-mentioned objects, features, and advantages will become more apparent from the following detailed description taken in conjunction with the accompanying drawings, which will enable those skilled in the art to easily implement the technical ideas of the invention.

[0030] In addition, when describing the invention, if it is determined that a detailed description of the prior art related to the invention may obscure the gist of the invention, the detailed description will be omitted. Hereinafter, a preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings.

[0031] FIG. 1 is a diagram showing the structure of an apparatus 100 for determining glycosylated hemoglobin values ​​according to the present invention.

[0032] Referring to FIG. 1, the glycosylated hemoglobin measuring device 100 according to the present invention may be comprised of an inlet 110 through which blood flows, a microchannel 130 through which red blood cells in the blood flowing into the inlet 110 pass, and an outlet 120 through which the red blood cells that have passed through the microchannel 130 are discharged.

[0033] In this embodiment, the glycosylated hemoglobin measuring device 100 is a plate-shaped chip, and a microchannel 130 may be formed between an inlet 110 and an outlet 120 that are open to the outside on the substrate, and an electrode unit 140 in which a plurality of patterned electrodes are connected and connected may be formed in the channel 130 between the inlet 110 and the outlet 120. The inlet 110 may have a larger diameter than the outlet 120 to facilitate the blood flow, and on the outlet 120 side, when coupled to the main body, the blood that has flowed into the inlet 110 may be guided to be discharged through the microchannel via a pump within the main body.

[0034] The electrode unit 140 may be formed in each of the micro flow channels on the inlet 110 side and the outlet 120 side, and each electrode unit 140 may have a plurality of electrodes arranged at predetermined intervals.

[0035] Specifically, the electrodes may be arranged perpendicular to the direction of blood flow in the microchannel and may be arranged at equal intervals along the flow direction. Furthermore, the interval between the electrodes may be set based on the size of one of the red blood cells for classification of the red blood cells passing through the channel.

[0036] In this embodiment, the electrodes in the electrode unit 140 may be configured in two groups of three, and an electric current flows between the three electrodes in the same group by allowing blood to pass through the electrolyte.

[0037] The glycosylated hemoglobin measuring device 100 according to this embodiment determines the degree of glycation using the time it takes for red blood cells in the blood to pass through a microchannel, and uses the change in impedance between electrodes to determine the time point at which the microscopic red blood cells pass, as will be described in more detail later.

[0038] The principle of determining the degree of glycation based on the time it takes for red blood cells to pass through the microchannel will be described with reference to FIG.

[0039] FIG. 2 is a diagram illustrating the process of red blood cells passing through a microchannel according to one embodiment of the present invention.

[0040] Referring to Figure 2, red blood cells 5 in the blood have elasticity like ordinary cells, so they can pass through passages with a width smaller than the typical size of red blood cells by reducing the diameter of their bodies. Based on this principle, red blood cells are characterized by the ability to change their shape and size according to their inherent stiffness in order to pass through minute blood vessels along with the blood. However, when the hemoglobin in red blood cells binds with the sugar components in the blood and becomes glycated, their physical stiffness increases, which reduces their elasticity and makes them harder.

[0041] Red blood cells, which have become more rigid due to the influence of glycated hemoglobin, take longer to pass through a passage of the same width, and the glycated hemoglobin measuring device of this embodiment measures the proportional relationship between the passage time (t=t1-t2) and the glycated hemoglobin value (HbA1C level).

[0042] Furthermore, in this embodiment, in order to more precisely measure the time it takes for small-sized red blood cells to pass through the microchannel, a parameter measured by configuring an electrical circuit is further utilized.

[0043] Hereinafter, a specific configuration of the glycosylated hemoglobin measuring device 100 according to this embodiment will be described with reference to FIG.

[0044] Figure 3 is a more enlarged and detailed view of the configuration of the flow channel 130 of the device shown in Figure 1. Referring to Figure 3, the micro flow channel 130 in the glycosylated hemoglobin measurement device 100 according to this embodiment may have electrodes patterned in a direction different from, preferably perpendicular to, the direction of fluid flow, arranged at predetermined intervals.

[0045] Specifically, the electrodes can be spaced at the same intervals at the position where they contact the microchannel, and the width of the electrodes can be made wider as they move away from the contact position, thereby further simplifying the circuit configuration.

[0046] In this embodiment, the electrodes are in direct contact with the fluid passing through the microchannel, allowing current to flow. Here, the current flowing between the electrodes is affected by the ion concentration of electrolytes in the microchannel. Specifically, when a red blood cell 5 is located between the electrodes, a change in impedance occurs. That is, the glycosylated hemoglobin measuring device 100 according to this embodiment makes it possible to measure the transit time of the red blood cell 5 through the microchannel based on the change in the impedance of the electrode unit 140.

[0047] Specifically, in order to calculate the transit time through the flow channel, the transit start time and transit end time of the red blood cells through the micro flow channel are measured, and the transit time of the red blood cells can be calculated using the difference between these times.

[0048] Therefore, in this embodiment, the electrode unit 140 may be composed of a first electrode unit 142 on the inlet 110 side and a second electrode unit 144 on the outlet 120 side.

[0049] At the first electrode portion 142, the time at which the red blood cells start to pass is measured by the change in impedance value, and at the second electrode portion 144, the time at which the red blood cells stop passing is measured by the change in impedance value, and the time at which the red blood cells pass through the flow path is calculated from the difference between the time at which the impedance value of the first electrode portion 142 changes and the time at which the impedance value of the second electrode portion 144 changes.

[0050] Furthermore, in this embodiment, each electrode unit can be composed of multiple electrodes. While a minimum configuration can be composed of an electrode for measuring the start time of passage through the channel and an electrode for measuring the end time of passage through the channel, it is also possible to configure a circuit with more electrodes to measure additional information such as the size and type of passing cells.

[0051] Specifically, referring to FIGS. 3 and 4, the first and second electrode portions 142 and 144 may each be composed of three consecutive electrodes.

[0052] That is, three consecutive electrodes in the electrode sections 142, 144 each generate two changes in impedance value, and changes in impedance values ​​Z1, Z2, Z3, and Z4 can occur on the inlet 110 side and the outlet 120 side, respectively.

[0053] Referring to FIG. 4, impedance values ​​Z1 and Z2 between the three electrodes 142a, 142b, and 142c in the first electrode unit 142 can be changed in sequence according to the order in which the red blood cells 5 pass through.

[0054] Conversely, although not shown, the impedance values ​​Z3 and Z4 of the three electrodes in the second electrode unit 144 can also be changed in sequence according to the order in which the red blood cells pass through.

[0055] The size and type of cells passing through can be inferred depending on the degree of change in the impedance value, thereby allowing for more accurate calculation of glycosylated hemoglobin values.

[0056] Furthermore, in this embodiment, the glycated hemoglobin measurement device 100 uses changes in the electrical equilibrium between the two resistances of the first and second electrode sections and the internal resistance of the glycated hemoglobin measurement main body 1000 to more sensitively measure minute changes in impedance values.

[0057] Referring to FIG. 5, the impedance generated by the relationship between the electrodes and the flow path shown in FIG. 3 can be configured to have an electrical balance in a bridge structure according to the circuit configuration of the glycosylated hemoglobin measuring main body 1000.

[0058] Specifically, the impedances Z1, Z2, Z3, and Z4 on the microchannel in FIG. 3 can correspond to the impedances of a Wheatstone Bridge circuit.

[0059] The bridge circuit can have a balanced state depending on the characteristics of the electrodes, the physical spacing, and the circuit configuration, and the respective impedance values ​​can have a relationship as shown in the following mathematical formula.

[0060] [Mathematical formula 1] Z1*R2=Z2*R1, Z3*R4=Z4*R3

[0061] In the circuit of FIG. 5, when each impedance value is in a balanced state as shown in Equation 1, no current may flow between points a and c and points A and C. However, as described above, when a red blood cell is positioned between the electrodes, a potential difference may occur due to an instantaneous change in impedance value.

[0062] That is, when a red blood cell is positioned at a certain point between the electrodes, a potential difference is generated due to the changed impedance, and in this embodiment, the time when the red blood cell passes through the electrodes can be determined based on the duration and magnitude of the minute current flowing between points a and c and points A and C. This makes it possible to measure minute changes in impedance value.

[0063] Specifically, changes in the first impedance and second impedance formed between two consecutive electrodes of the first electrode unit 142, and the third impedance and fourth impedance formed between two consecutive electrodes of the second electrode unit 144 are measured more sensitively using changes in the electrical balance state in the Wheatstone bridge circuit, and the transit time through the microchannel is calculated using the change time.

[0064] Referring to Figure 6, in this embodiment, the glycosylated hemoglobin measuring device 100 is a sensor chip constructed of the substrate of the above-mentioned form, and may include a main body 1000 for connecting to the chip and outputting the measurement results, and it is also possible to miniaturize the chip and all measuring equipment.

[0065] The main body 1000 provides power so that current flows through the microchannel 130 and electrode structure within the glycosylated hemoglobin measuring device 100, measures the time it takes for the impedance value to change, calculates the glycosylated hemoglobin value using the measured time difference, and outputs it via a panel.

[0066] Specifically, referring to FIG. 7, the glycosylated hemoglobin device main body 1000 may be composed of a time measurement unit 1100, a glycosylated hemoglobin value calculation unit 1200, a glycosylated hemoglobin value correction unit 1300, and a flow rate forming pump 1400.

[0067] The time measurement unit 1100 can measure the passage time through the microchannel by using the difference between the time of change in impedance value caused by the passage of red blood cells in blood at a first point on the microchannel 130 formed in contact with the electrode unit 140 between the blood inlet 110 and the outlet 120 and the time of change in impedance value at a second point on the microchannel 130.

[0068] In this embodiment, the first point is a point on the first electrode unit 142, preferably between the electrodes, or may be defined as a predetermined area on the microchannel. The second point may also be determined on the second electrode unit 144 corresponding to the first point.

[0069] The time measurement unit 1100 calculates the transit time of red blood cells through the micro flow channel from the difference between the time of change in the impedance value of the first electrode unit 142 and the time of change in the impedance value of the second electrode unit 144 .

[0070] Specifically, the time measurement unit 1100 can calculate the passage time through the microchannel using the difference between the time it takes for the impedance value to change due to a red blood cell being positioned between at least one pair of electrodes in the first electrode unit 142 and the time it takes for the impedance value to change due to a red blood cell being positioned between at least one pair of electrodes in the second electrode unit 144.

[0071] The glycated hemoglobin value calculation unit 1200 calculates the degree of glycation of blood using the correlation between the time it takes to pass through the microchannel and the glycation of red blood cells in the blood.

[0072] Since the probability that each red blood cell will come into contact with and bind to sugar components in the blood varies depending on the time period in which it was produced, the glycosylated hemoglobin value of each individual red blood cell may vary.

[0073] Specifically, the glycosylated hemoglobin value data of each individual red blood cell at the time of measurement can show a specific data distribution, and the representative value that indicates the characteristics of the distribution can vary depending on the glycosylated hemoglobin value.

[0074] Here, the difference between the representative values ​​can be derived as a mathematical formula based on clinical data that is sufficiently secured by the correlation between the microchannel transit time and the glycated hemoglobin value, and the glycated hemoglobin value calculation unit 1200 finally calculates the degree of blood glycation using the derived correlation formula and the measurement data measured by the time measurement unit 1100.

[0075] In this embodiment, the glycated hemoglobin value calculation unit 1200 continuously measures the transit time of red blood cells in the order in which they enter, so that even if multiple red blood cells enter at the same time, the transit time of each individual red blood cell can be measured, and ultimately, a highly accurate correlation equation can be calculated in a short time to calculate the degree of glycation.

[0076] Furthermore, in order to determine a more accurate glycosylated hemoglobin value taking into account individual characteristics, a glycosylated hemoglobin value correction unit 1300 for correcting the value using a reference glycosylated hemoglobin value measured by the user at a hospital may be included. Here, additional information such as the size and type of cells measured by the electrodes may be used.

[0077] 2, a structure for guiding the movement of red blood cells in the blood from the inlet 110 to the outlet 120 is formed, which can serve as a flow rate forming pump 1400. A mixed solution consisting of blood and electrolytes moves from the inlet 110 to the outlet 120 via the flow rate forming pump 1400 in the order described with reference to FIG. 2. Here, an electrical signal due to impedance that changes with the movement of cells is measured by the measuring unit 1100, and the glycosylated hemoglobin value is calculated by the calculating unit 1200 using the measured value.

[0078] Furthermore, the data distribution formed by the glycosylated hemoglobin value data of each individual red blood cell can be used to determine the user's glycosylated hemoglobin management status. Red blood cells exist in the blood with an average lifespan, so the lifespan of red blood cells and the glycosylated hemoglobin value can be correlated with each other.

[0079] In other words, when diabetes or glycosylated hemoglobin is not specially managed, or regular management is maintained without any change in medication or treatment from the existing management state, the frequency of red blood cells according to glycosylated hemoglobin values ​​is similar to the frequency of red blood cells according to lifespan.

[0080] Here, when a user starts taking medication to manage the glycosylated hemoglobin level, the glycosylated hemoglobin level of newly generated red blood cells decreases, and the distribution of red blood cells with relatively low rigidity increases. Such changes can appear as a characteristic of the distribution.

[0081] Referring to Figure 9, even if the patients have the same average glycosylated hemoglobin value (7% HbA1c), the distribution graph of red blood cell counts according to red blood cell rigidity shows a difference in distribution, as in the case of unmanaged patient A and managed patient B. In other words, the similarity between the red blood cell frequencies decreases depending on the lifespan of the red blood cells.

[0082] Therefore, the user's health management status can be objectively assessed based on changes in the distribution of glycosylated hemoglobin values ​​for each individual red blood cell calculated by the glycosylated hemoglobin measuring device of this embodiment, and by presenting a health management strategy based on changes in the distribution in addition to the current status using representative values ​​of glycosylated hemoglobin values, it becomes possible to more effectively prescribe and manage chronic diseases. Furthermore, by comparing the degree of change in management status for each user, it becomes possible to further prescribe treatment tailored to the characteristics of each user.

[0083] Hereinafter, with reference to FIG. 8, a measurement method performed by the glycosylated hemoglobin measuring device according to this embodiment will be described.

[0084] Referring to FIG. 8, first, at a first point on the microchannel 130 formed in contact with the electrode unit 140 between the blood inlet 110 and the outlet 120, the time of change in impedance value accompanying the passage of red blood cells in the blood is measured (S100).

[0085] Next, the time for which the impedance value changes is measured at a second point in the flow path (S200).

[0086] Here, the first point can be determined as at least one position on the area where the first electrode unit 142 on the inlet side and the microchannel 130 contact, and the second point can be determined as at least one position on the area where the second electrode unit 144 on the outlet side and the microchannel 130 contact, and the first or second impedance change time can be measured from the change in impedance value due to the red blood cells passing through the channel being positioned between a pair of electrodes in the first or second electrode unit 142, 144.

[0087] Next, the flow path transit time is measured using the difference between the measured first impedance change time at the first point and the measured second impedance change time at the second point (S300).

[0088] Next, the blood glycated hemoglobin value is calculated using the proportional relationship between the measured passage time and the glycation of red blood cells in the blood (S400).

[0089] In addition, the calculated blood glycosylated hemoglobin value can be corrected based on the user's reference glycosylated hemoglobin value, making it possible to use it for clinical judgment (S500).

[0090] As described above, according to the present invention, the degree of glycation can be easily measured by utilizing the change in the physical properties of red blood cells due to glycation of the red blood cells.

[0091] In addition, by calculating the degree of hardness of each individual red blood cell from the time it takes to pass through a fine channel, the degree of glycation can be determined more stably against external and human factors than measurement equipment using biochemical techniques.

[0092] Furthermore, the present invention uses a simple circuit configuration to recognize minute electrical changes that occur when red blood cells pass through, thereby making it possible to determine the degree of glycation of red blood cells.

[0093] Furthermore, the present invention can be directly utilized in clinical diagnosis by correcting the measured glycated hemoglobin values ​​using individual reference values.

[0094] Furthermore, the various embodiments described herein may be implemented, for example, using software, hardware, or a combination thereof in a computer-readable storage medium or similar device.

[0095] According to a hardware implementation, the embodiments described herein may be implemented using at least one of application specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field programmable gate arrays (FPGAs), processors, controllers, micro-controllers, microprocessors, or other functionally performing electrical units. In some cases, the embodiments described herein may be implemented as the control module itself.

[0096] In a software implementation, the procedures and functions described herein may be implemented in separate software modules, each of which may perform one or more of the functions and operations described herein. The software code may be implemented in a software application written in a suitable programming language. The software code may be stored in a memory module and executed by a control module.

[0097] The above description is merely an illustrative example of the technical concept of the present invention, and various modifications, changes, and substitutions can be made by a person having ordinary knowledge in the technical field to which the present invention pertains, without departing from the essential characteristics of the present invention.

[0098] Therefore, the embodiments and accompanying drawings disclosed in the present invention are for explanation purposes only, and are not intended to limit the technical idea of ​​the present invention. The scope of protection of the present invention should be interpreted by the following claims, and all technical ideas within the scope equivalent thereto should be interpreted as being included in the scope of the present invention.

Claims

1. an inlet through which collected blood flows; a microchannel having a predetermined width so that red blood cells in the blood flowing into the inlet pass through individually; an outlet through which red blood cells that have passed through the microchannel are discharged; a plurality of electrode units formed in contact with the microchannel between the inlet and the outlet, the electrode unit includes a plurality of electrodes arranged at predetermined intervals along the direction in which red blood cells pass through the microchannel; The electrode unit is for measuring the transit time of the red blood cells through the microchannel for calculating the glycosylated hemoglobin value. A change in impedance value at a first point on the microchannel due to red blood cells in the blood passing through the first point; a change in impedance value at a second point of the microchannel; and Sense the the electrode unit is composed of a first electrode unit on the inlet side and a second electrode unit on the outlet side, the first and second electrode portions each include three consecutive electrodes; A device for measuring glycosylated hemoglobin, characterized in that the electrical equilibrium state of the first impedance and the second impedance formed between two consecutive electrodes of the first electrode unit, and the electrical equilibrium state of the third impedance and the fourth impedance formed between two consecutive electrodes of the second electrode unit, each change due to the passage of the red blood cells.

2. A glycated hemoglobin measuring device as described in claim 1, characterized in that the impedance between at least one pair of electrodes in the first electrode unit and the impedance between at least one pair of electrodes in the second electrode unit change due to the passage of the red blood cells.

3. a time measuring unit that measures the time taken for red blood cells to pass through the microchannel by using the difference between a time period during which an impedance value changes due to the passage of red blood cells in the blood at a first point on the microchannel formed in contact with an electrode unit between the blood inlet and the outlet, and a time period during which an impedance value changes at a second point on the microchannel; a glycosylated hemoglobin value calculation unit that determines the degree of glycation of red blood cells in the blood from the measured time, The glycated hemoglobin value calculation unit calculates the degree of glycation of blood using the proportional relationship between the transit time through the microchannel and the glycation of red blood cells in the blood.

4. the electrode unit is composed of a first electrode unit on the inlet side and a second electrode unit on the outlet side, 4. The glycosylated hemoglobin measuring device according to claim 3, wherein the time measuring unit calculates the transit time of the red blood cells through the microchannel from the difference between the change time of the impedance value of the first electrode unit and the change time of the impedance value of the second electrode unit.

5. the first and second electrode portions are composed of a plurality of electrodes, 5. The glycosylated hemoglobin measuring device according to claim 4, wherein the time measuring unit calculates the transit time through the microchannel using the difference between the time of change in impedance value caused by the red blood cell being positioned between at least one pair of electrodes in the first electrode unit and the time of change in impedance value caused by the red blood cell being positioned between at least one pair of electrodes in the second electrode unit.

6. 4. The apparatus for measuring glycated hemoglobin according to claim 3, further comprising a glycated hemoglobin value correcting unit for correcting the degree of glycation of the blood using a user's reference glycated hemoglobin value.

7. the first and second electrode portions each include three consecutive electrodes; 6. The glycosylated hemoglobin measuring device according to claim 5, wherein the time measuring unit measures a change in impedance value using a change in an electrically parallel state of a first impedance and a second impedance formed between two consecutive electrodes of the first electrode unit and an electrically balanced state of a third impedance and a fourth impedance formed between two consecutive electrodes of the second electrode unit, and calculates a transit time through the microchannel using a time of change.

8. measuring a time period during which an impedance value changes as red blood cells pass through the microchannel at a first point on the microchannel formed in contact with an electrode portion between the blood inlet and the blood outlet; measuring a time period during which the impedance value changes at a second point of the microchannel; measuring a flow path time using a difference between the measured first impedance change time at the first point and the measured second impedance change time at the second point; calculating a glycosylated hemoglobin value based on the measured flow path transit time; A method for measuring glycated hemoglobin, characterized in that the step of calculating the glycated hemoglobin value calculates the degree of glycation of blood using the proportional relationship between the transit time through the microchannel and the glycation of red blood cells in the blood.

9. The first point is determined as at least one position on an area where the first electrode unit on the inlet side and the microchannel are in contact with each other, The method of claim 8, wherein the second point is determined as at least one position on an area where the second electrode unit on the outlet side and the microchannel are in contact with each other.

10. 10. The method for measuring glycosylated hemoglobin according to claim 9, wherein the first or second impedance change time is measured based on a change in impedance value caused by red blood cells passing through the microchannel being positioned between a pair of electrodes in the first or second electrode unit.

11. The method for measuring glycated hemoglobin according to claim 8, further comprising the step of correcting the calculated blood glycation level using a user's reference glycated hemoglobin value.

12. the first and second electrode portions each include three consecutive electrodes; the step of measuring the transit time through the microchannel includes measuring a change in an impedance value using a change in an electrical equilibrium state of a first impedance and a second impedance formed between two consecutive electrodes of the first electrode unit and a change in an electrical equilibrium state of a third impedance and a fourth impedance formed between two consecutive electrodes of the second electrode unit; 10. The method for measuring glycosylated hemoglobin according to claim 9, wherein the time taken for the impedance value to change is used to calculate the time taken for the sample to pass through the microchannel.

Images