KR102200043B1 - Apparatus and method for measuring cholesterol using micro blood volume - Google Patents

Abstract

The present invention relates to a cholesterol measuring apparatus and method capable of obtaining a cholesterol measurement concentration value using a trace amount of a measurement sample (blood), comprising the steps of: seating a cartridge into which the measurement sample is inserted; The lower support of the mounted cartridge is horizontally moved in the first direction to sequentially align the membranes of the two supports, while vertically moving the upper support to transfer the measurement sample at each alignment position to bring the membranes of the two supports into contact with each other. In this released state, while horizontally moving the lower support in the opposite direction to the first direction, the color information of the sample measuring membrane is measured at each alignment position to calculate the cholesterol level.

Description

Cholesterol measuring device using a micro blood volume and its method TECHNICAL FIELD [APPARATUS AND METHOD FOR MEASURING CHOLESTEROL USING MICRO BLOOD VOLUME}

The present invention relates to a cholesterol measuring apparatus and method capable of obtaining a cholesterol measurement concentration value using a trace amount of a measurement sample (blood).

As the demographic structure has changed due to the recent aging society, interest in health is increasing, and the need for health examination equipment is increasing, and the possibility as a new market is increasing.

In general, a patient's health status is diagnosed by analyzing the patient's body fluids and measuring the amount or concentration of a substance (hereinafter referred to as an indicator substance) related to the patient's health status such as disease or pregnancy. Measurement of an indicator substance is performed through biochemical reactions such as antigen-antibody reactions to the indicator substance by collecting body fluids from the patient. In the past, since reagents or equipment requiring specialized knowledge were used for these tests, it was expensive and time-consuming, and there were many restrictions on patients because they could only be diagnosed by visiting a hospital.

Recently, a point-of-care test (POCT) has emerged that overcomes the shortcomings of these inspection methods. The field test is a test that diagnoses a patient within a short time by performing the collection and analysis of bodily fluids at the patient's site.

The on-site examination is widely performed because it has various advantages, such as a simple method that allows the patient to diagnose itself, as well as save additional cost and time. Among these biochemical field test items, items that are frequently used include cholesterol (TG, TC, HDL, LDL), blood sugar (Glucose), and liver disease measuring devices (AST, ALT). Biosensors for measuring these items are being performed by a method using electrochemical and optical (LED, PD).

A cholesterol measuring device (biosensor) using optics typically uses a color reaction, and a representative reaction formula is as follows.

-Cholesterol (TC, HDL, LDL)

When using a biosensor using a color development reaction using the representative reaction equation, there is a method of using a solution itself as a medium for fluid movement or measurement, and a method of using a membrane.

1 shows the appearance of a general cholesterol measuring device.

As shown in FIG. 1, the measurer inserts the cartridge 20 into the receiving part (not shown) of the measuring device 10 and then injects blood through the blood inlet 12 or inserts blood into the cartridge 20. After loading, the cartridge can be inserted into the receiving part.

2 is a detailed structure of a measuring cartridge inserted into a cholesterol measuring device.

As shown in Fig. 2, the conventional cartridge 20 reacts with the upper support 1 and the filtration membrane 1b including a filtration membrane 1a and a spread membrane 1b. It comprises a lower support (3) containing a membrane (3b). Ends of the upper and lower supports 1 and 3 are fixed to each other through an elastic member 2.

The filtration membrane 1a serves to deliver serum by filtering red blood cells (RBC) from the blood injected through the sample inlet 12 of the device, and the diffusion membrane 1b serves to diffuse the delivered serum. Do it. In particular, the diffusion membrane 1b provided in the upper support 1 is a fluid (liquid) movement passage, and its length is the same as the distance between the membranes at both ends of the lower support 3.

3 is a view showing an operation of measuring cholesterol using a conventional cholesterol measuring device.

As shown in FIG. 3, when the cartridge 20 is inserted into the receiving part (not shown) of the measuring device 10 and then blood is injected through the blood inlet 12, the blood is transferred from the filtration membrane 1a to the red blood cells. The serum from which (RBC: red blood cells) has been filtered is delivered to the diffusion membrane (1b). Thereafter, when the cartridge 20 is vertically moved using a driving means, the diffusion membrane 1b and the three diffusion membranes 3a come into contact, so that the serum is transferred from the diffusion membrane 1b through each diffusion membrane 3a. It is transferred to the three reaction membranes 3d. After that, the cartridge 20 is moved to its original position by using a driving means again, and light is projected onto each reaction membrane 3d using optical parts (LED, PD). Then, by checking the color development reaction of the reaction membrane (3d), finally, three kinds of cholesterol items (TC, TG, HDL) are simultaneously measured. The measured cholesterol level is displayed on the display.

As described above, when measuring three kinds of cholesterol items (TC, TG, HDL) at the same time in a conventional cholesterol measurement device, a passage through which the liquid (serum) can flow to send the serum from the blood to the reaction membrane 3b. That is, the diffusion membrane 1b is absolutely necessary.

However, when the fluid movement passage is constituted by the membrane 1b as in the related art, a dead volume in which the membrane 1b contains a large amount of fluid is generated by adsorption and diffusion during fluid movement.

As a result, the minimum amount of fluid for cholesterol measurement is not evenly delivered to the reaction membrane 3b or a small amount of fluid is delivered, making it impossible to obtain accurate measurement results.In order to obtain accurate measurement results, a larger amount of fluid ( There is a downside to using blood).

An object of the present invention is to provide a cholesterol measuring apparatus and method capable of obtaining accurate cholesterol measurement results using a microscopic blood volume by reducing the dead volume generated during fluid movement.

Another object of the present invention is to provide a cholesterol measuring apparatus and method capable of removing uneven distribution of serum to the membrane caused by the membrane pathway and variations caused by the membrane.

In order to achieve the above object, an apparatus for measuring cholesterol according to an embodiment of the present invention includes: a receiving part provided in a main body; A cartridge comprising an upper support having a sample delivery membrane and a membrane having a plurality of sample measurement membranes, and seated in the receiving portion; A cartridge driving unit for moving the upper and lower supports of the cartridge; A memory for storing setting information related to cartridge movement and membrane contact; And a control unit that moves the lower support of the cartridge horizontally to sequentially align the membranes of the upper and lower supports, and vertically moves the upper support at each alignment position for transferring a measurement sample to contact the membranes of the two supports.

In order to achieve the above object, a method for measuring cholesterol according to an embodiment of the present invention is a method for measuring cholesterol using a cartridge having an upper support having a membrane for sample delivery and a membrane having a membrane for measuring a plurality of samples, Seating the cartridge into which the sample has been added to the receiving unit; Aligning the membranes of the two supports in sequence by horizontally moving the lower supports of the cartridge in the first direction according to the setting information, and vertically moving the upper supports to transfer the measurement sample at each alignment position to contact the membranes of the two supports; Measuring color information of the sample measuring membrane at each alignment position while horizontally moving the lower support in a direction opposite to the first direction in a state in which the contact of the membrane is released; And calculating cholesterol levels by analyzing the color information of the membrane for measuring the measured sample.

In the present invention, the dead volume generated during fluid movement can be reduced by excluding the existing membrane path, and a plurality of reaction membranes provided on the lower support for a sample (serum) of the upper support by contact between the membranes based on horizontal movement of the lower membrane By delivering it to the frame, there is an effect of obtaining a concentration measurement result using only a small amount of blood.

In addition, the present invention can eliminate deviations arising from the membrane path through which the fluid moves, for example, uneven distribution of serum to the membrane (measurement item), deviations caused by the membrane, and the like. In order to quantitatively deliver the filtered serum to the reaction membrane, the measurement sequence and contact time can be controlled, so that more accurate concentration measurement results can be obtained than before.

1 is an external view of a general cholesterol measurement device.
Figure 2 is a detailed structure of the measuring cartridge inserted into the cholesterol measuring device.
3 is a view showing an operation of measuring cholesterol using a conventional cholesterol measuring device.
Figure 4 is a block diagram of a cholesterol measuring device according to an embodiment of the present invention.
5 and 6 are configuration diagrams of a cartridge according to the present invention.
7 is a plan view of a cartridge according to the invention.
Figure 8 is a flow chart showing a cholesterol measurement method using a micro blood volume according to an embodiment of the present invention.
9A and 9B are views showing a detailed embodiment of FIG. 8.

In the present invention, the membrane path is removed to reduce the dead volume generated during fluid movement, and the blood (fluid) for measurement is supplied by moving the cartridge, so that accurate cholesterol measurement results can be obtained using only a small amount of blood. We propose a biosensor and its measurement method.

The present invention uses an optical cholesterol measuring device (biosensor), which measures three kinds of cholesterol items (TC, TG, HDL) using a membrane.

4 is a block diagram of an apparatus for measuring cholesterol according to an embodiment of the present invention.

As shown in Fig. 4, the cholesterol measurement apparatus according to the present invention includes a cartridge receiving unit 100 accommodating a cartridge 200, a cartridge driving unit 101 controlling vertical and horizontal movement of the cartridge within the accommodating unit, and a cartridge ( A measurement unit 102 that detects color development information by projecting an optical signal on the reaction membrane of 200), a memory 103 that stores setting information and measured cholesterol level for measuring the color development information, and controls the operation of each unit And, the control unit 180 for calculating the cholesterol level (concentration measurement result value) by processing the color information detected by the measurement unit 102, and a display unit 105 that displays the cholesterol level measured by the control unit 1800. Include.

The setting information for measuring the color development information is information that can be set by a measurer, and may include an initial alignment position of a membrane, a membrane contact time, a cholesterol measurement item, and a horizontal and vertical moving distance of the membrane. Therefore, if it is assumed that there are two measurement items, only two (two pairs) of the membranes of the lower support 26 in FIG. 5 contact the membrane of the upper support 21 and measure color information according to the setting information. Will be

The cartridge receiving part 100 may be attached to one of the lower, side, and upper surfaces of the cholesterol measuring device.

The measuring unit 102 selects an LED (LED) that outputs an optical signal to the reactive membrane of the cartridge, a photodiode (PD) that detects an optical signal reflected from the reactive membrane of the trige, and a required image from the detected optical signal. Thus, it includes a signal processing module provided to the control unit 104.

The cartridge driving unit 101 includes a vertical moving motor for vertically moving the upper support of the cartridge 200 and a vertical moving motor for horizontally moving the lower support. The cartridge driving unit 101 serves to accurately align the membrane of the upper support and the membrane of the lower support.

The control unit 104 converts the color information detected by the measurement unit 102 into digital information, a control module for driving each motor of the cartridge driving unit 101, a control module for controlling the measurement unit 102, and It may be provided with an A/D converter and a signal processing module to process and a concentration extraction module to finally measure cholesterol levels.

5 and 6 are configuration diagrams of a cartridge 200 according to the present invention.

5 and 6, the cartridge 200 according to the present invention largely includes a main body 30, a main filtration membrane 22 and a spreading membrane 23. It consists of a support (21), a filtration membrane (24) and a lower support (26) comprising a reaction membrane (25).

The filtration membrane 22 serves to deliver serum by filtering red blood cells (RBC) from the blood injected through the sample inlet (not shown) of the device, and the diffusion membranes 23 and 24 It plays a role in spreading.

The reaction membrane 26 has a reaction layer for cholesterol measurement items, that is, TC (total cholesterol), TG (triglyceride), and HDL (high-density lipoprotein), thereby causing a color reaction to light.

The upper support 21 is fixedly attached to the main body 30 through an elastic member 21a and is positioned to vertically cross the lower support 25 at a predetermined height. The elastic member 21a is positioned between the lower surface of the upper support 21 and the upper surface of the main body 30 as shown in FIG. 6, and fixes the upper support 21 to the main body 30. The elastic member 21a contracts when the upper membrane 21 moves vertically to contact the membranes of the upper and lower supports.

The main body 30 has a shape of a lower support 26, and a portion 32 smaller than the size of the lower support is cut, and both sides of the cut surface are bent in an'L' shape to guide the horizontal movement of the lower support 26. To form a guide portion 31 for. The lower support 26 is formed equal to or higher than the horizontal surface of the main body 30.

A driving hole 26a is provided at one end of the lower support 26, so that the cartridge can be horizontally moved by fitting the driving hole 26a into a protrusion (not shown) of the cartridge driving unit 101. .

7 is a plan view of a cartridge 200 according to the present invention.

As shown in FIG. 7, when the cartridge 200 is seated in the cartridge receiving part 100 of the cholesterol measuring device, the membranes 22 and 23 of the upper support 21 are at the far right of the lower support 26. Aligned with (24,25) (first position).

Thereafter, when the cartridge 200 is horizontally moved to the right using the cartridge driving unit 101, the other membranes 24 and 25 in the lower support 26 will be in turn aligned with the membranes 22 and 23 of the upper support 21. It can be (second and third positions), at this time, assuming that the moving speed is constant, the horizontal moving distance is set in advance based on the distance between the membranes on the lower support 26.

In the present invention, the alignment position of the membrane may be set as the first position as the basic alignment position, and the third alignment position may be set as the basic alignment position under the control of the controller 104.

8 is a flow chart showing a method of measuring cholesterol using a microscopic blood volume according to an embodiment of the present invention, and FIGS. 9A and 9B show detailed examples thereof.

As shown in FIGS. 8 and 9A, first, the measurer seats the cartridge 200 into which blood is injected into the cartridge receiving part 100 of the measuring device (S100). At this time, red blood cells (RBC) are filtered through the filter membrane 22 of the cartridge, and only serum is transferred to the diffusion membrane 23.

The accommodating part 100 includes both an insertion type provided on the lower or side surface to insert the cartridge or a seating type including a cover provided on the upper side. In addition, the blood may be injected through the injection port after the cartridge is first injected.

At this time, the controller 104 may detect the seating state of the cartridge and, when the seating state is unstable, may notify the measurer through the display unit 105 or a separate sound output module (not shown).

When the cartridge is seated in the receiving unit 100, the control unit 180 determines the position and number of membranes from the memory 103 based on the type and type of the cartridge, and generates a drive control signal according to the determined information. Controls the drive unit 101.

First, the control unit 104 may move the lower support 25 so that the membrane of the cartridge is aligned with the first position (S110). The first position is a basic position, and as shown in FIG. 9A, it means a position in which the right membrane of the lower support 26 is aligned with the membrane of the upper support 21.

As another embodiment, the first position may be a position in which the left membrane of the lower support 26 is aligned with the membrane of the upper support 21. The first position can be set by the measurer before starting the measurement, and according to the setting information, the control unit 104 controls the horizontal moving motor of the cartridge driving unit 101 to horizontally move the lower support 26 of the cartridge to the set position. .

When the membrane of the upper support 21 and the right membrane of the lower support 26 are aligned in the first position, the control unit 104 controls the vertical moving motor of the cartridge driving unit 101 to vertically move the upper support 21 downward. By moving, the membranes are brought into contact (first contact) (S120). By the first contact, the serum in the diffusion membrane 23 of the upper support 21 is transferred to the reaction membrane 25 through the diffusion membrane 24 of the lower support 26. The first contact is maintained for a preset time.

When the contact time elapses, the control unit 104 releases the first contact by controlling the vertical movement motor of the cartridge driving unit 101 to vertically move the upper support 21 upward (S130).

In this state, the control unit 104 checks whether there is a next membrane to be contacted (S140), and if there is a next membrane, controls the horizontal movement motor of the cartridge driving unit 101 again to move the lower support 26 of the cartridge to the next position (removal). Position 2) horizontally and align it (S150). On the other hand, if there is no next membrane, light is immediately transmitted to check the color spot, and the measurement process is terminated (S160, S170).

In the present invention, three membranes (pairs) are used because memrein with a reaction layer for three cholesterol measurement items, namely, TC (total cholesterol), TG (triglyceride), and HDL (high-density lipoprotein) is used. . Accordingly, the control unit 104 will horizontally move the lower support 26 of the cartridge to the next position (second position).

When the membrane of the upper support 21 and the central membrane of the lower support 26 are aligned in the second position, the control unit 104 vertically moves the upper support 21 of the cartridge driving unit 101 downward to make contact with the membrane. Perform (2nd contact) (S120). By the second contact, the serum in the diffusion membrane 23 of the upper support 21 is transferred to the reaction membrane 25 through the diffusion membrane 24 at the center of the lower support 26. The second contact is maintained for the same time as the first contact.

When the contact time elapses, the control unit 104 vertically moves the upper support 21 of the cartridge driving unit 101 to release the second contact (S130), and checks whether there is a next membrane to be contacted again (S140). However, since one membrane to be contacted still remains, the controller 104 again controls the horizontal moving motor of the cartridge driving unit 101 to horizontally move the lower support 26 of the cartridge to the next position (third position). Align (S150)).

When the membrane of the upper support 21 and the left side of the lower support 26 are aligned in the third position, the control unit 104 vertically moves the upper support 21 of the cartridge driving unit 101 downward again, and contacts the membrane. Performs (third contact) (S120).

When the third contact is completed at the third position, the controller 180 enters the step of measuring the color development information of the reaction membrane because all the membrane contact processes are completed.

The measurement of the color development information includes a series of operations of detecting the reflected light by projecting light onto the serum delivered to the reaction membrane 25 as a result of the first to third contact. The measurement of the color information starts from the position where the final contact is released, that is, the third contact is released.

Referring to FIG. 9B, when the third contact is completed, the controller 180 vertically moves the upper support 21 to release the third contact, and then measures the color information of the right reaction membrane 25 at the third position. (First measurement). The color development information is measured by projecting light from the LED (LED) of the measuring unit 102 to the reaction membrane 25 and then receiving the reflected light from the reaction membrane 25 by the photodiode PD.

When the first measurement is completed at the third position, the control unit 104 checks whether the reaction membrane (previous membrane) to measure the color development information exists (S170), and if there is, horizontally moves the lower support 26 to the left. After moving, the membrane of the upper support 21 and the central membrane of the lower support 26 are aligned (second position) (S180), and the color information of the central reaction membrane 25 is measured at the second position (second position). 2 measurements). On the other hand, if it does not exist, the process of measuring color development information is terminated.

When the second measurement is completed at the second position, the control unit 104 horizontally moves the lower support 26 to the left again in the same way, aligning the membrane of the upper support 21 and the left membrane of the lower support 26 After making it (first position), the color information of the left reaction membrane 25 is measured at the first position (third measurement).

Accordingly, the control unit 104 receives the color development information of the three reaction membranes 25 measured through the first to third measurements from the measurement unit 102 and converts it into the concentration value of the reaction substance through the concentration extraction module. Measurement results of cholesterol measurement items, that is, TC (total cholesterol), TG (triglyceride), and HDL (high-density lipoprotein) are displayed on the display unit 105.

As described above, the present invention can reduce the dead volume generated during fluid movement by excluding the existing membrane path, and the sample (serum) of the upper support is provided on the lower support by inter-membrane contact based on the horizontal movement of the lower membrane. By transferring to a plurality of reaction membranes, it is possible to obtain a concentration measurement result using only a small amount of blood.

In addition, the present invention removes the membrane path through which the fluid moves, thereby eliminating deviations arising therefrom, for example, non-uniform distribution of serum to the item to be measured, deviations caused by the membrane, and the like. Since the measurement sequence and contact time can be controlled in order to quantitatively deliver the resulting serum to the reaction membrane, it is possible to obtain more accurate concentration measurement results than before.

As described above, the present invention has an effect of obtaining a concentration measurement result using only a small amount of blood by removing a membrane path including a dead volume generated in fluid movement using a cartridge and a system.

In addition, the present invention removes the membrane path through which the fluid moves, thereby eliminating deviations arising therefrom, for example, uneven distribution of serum to the item (membrane) to be measured, deviations caused by the membrane, and the like. Since the contact time can be controlled to quantitatively deliver the serum of the blood to the reaction film, it has the effect of obtaining more accurate concentration measurement results.

The apparatus and method for measuring cholesterol using a microscopic blood volume according to the present invention described as described above are not limited to the configuration and method of the above-described embodiments, but the embodiments are not limited to the technical idea or essential features thereof. It will be appreciated that it can be implemented in other specific forms without modification. Therefore, the above-described embodiments are illustrative in all respects and should be understood as non-limiting.

100: cartridge receiving unit 101: cartridge driving unit
103: measuring unit 103: memory
104: control unit 105: display unit

Claims (11)

A receiving portion provided in the body;
A cartridge configured as an upper support having a sample delivery membrane and a lower support having a plurality of sample measurement membranes and seated in the receiving portion;
A cartridge driving unit for moving the upper and lower supports of the cartridge;
A memory for storing setting information related to movement of the support and contact with the membrane; And
And a control unit for sequentially aligning the membranes of the two supports by horizontally moving the lower support according to the setting information, and vertically moving the upper support for transferring the measurement sample at each alignment position to bring the membranes of the two supports into contact with each other; Cholesterol measuring device, characterized in that. The method of claim 1, wherein the setting information
An apparatus for measuring cholesterol, comprising: an initial alignment position of the membrane, a membrane contact time, a cholesterol measurement item, and a horizontal and vertical movement distance of the membrane. The method of claim 1, wherein the sample delivery membrane
A cholesterol measuring device comprising a filtration membrane and a diffusion membrane, wherein the sample measurement membrane is composed of a diffusion membrane and a reaction membrane. The method of claim 1, wherein the cartridge
A main body in which one area is cut into a U shape;
A lower support having a plurality of overlapping diffusion membrane/reactive membrane pairs and disposed in a guide portion in a cut region of the body in a longitudinal direction;
An upper support having one filtration membrane/diffusion membrane pair and perpendicular to the lower support;
Elastic members fixing both sides of the upper support to the body; And
Cholesterol measuring apparatus comprising a; drive hole positioned on one side of the lower support and fitted to the protrusion of the cartridge driving unit. delete delete delete In the cholesterol measurement method using a cartridge consisting of an upper support having a sample delivery membrane and a lower support having a plurality of sample measurement membranes,
Seating the cartridge into which the measurement sample has been added to the receiving unit;
Aligning the membranes of the two supports in sequence by horizontally moving the lower supports of the cartridge in the first direction according to the setting information, and vertically moving the upper supports to transfer the measurement sample at each alignment position to contact the membranes of the two supports;
Measuring color information of the sample measuring membrane at each alignment position while horizontally moving the lower support in a direction opposite to the first direction in a state in which the contact of the membrane is released; And
Cholesterol measurement method comprising; analyzing the color information of the membrane for measuring the measured sample to calculate the cholesterol level. delete delete delete

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