KR20190097605A - Compact multi molecular diagnosis system - Google Patents

Abstract

The present invention relates to a small multi-molecular diagnostic system, which comprises a card portion, a collecting portion, a washing portion, a reagent unit, a heating portion, and an optical unit, wherein the card portion is moved on a rotating frame and partitioned into a plurality of regions, the collecting portion provides collected blood to each region of the card portion, the washing portion provides a washing liquid to the card portion to wash the blood collected in the card portion, the reagent unit provides a plurality of diagnostic reagents respectively to respective regions of the card portion, the heating portion replicates viruses by heating the card portion in which the reagent is absorbed, and the optical unit observes the replicated viruses. In addition, the card portion sequentially moves to the collecting portion, the washing portion, the reagent unit, the heating portion, and the optical unit.

Description

Compact multi-molecular diagnostic system {COMPACT MULTI MOLECULAR DIAGNOSIS SYSTEM}

The present invention relates to a multi-molecular diagnostic system, and more particularly, to a multi-molecular diagnostic system that can be automated from pre-treatment to measurement as a molecular diagnostic technology using paper, and capable of multiple molecular diagnostics and is made portable or compact. will be.

Molecular diagnostic techniques include the detection of genetic diseases, the identification of genetic fingerprints, and the diagnosis of infectious diseases in the fields of medicine and biology. It is widely applied for the purpose of analysis or diagnosis for cloning gene, paternity test or DNA computing.

Representative polymerase chain reaction (PCR) apparatus is a representative DNA amplification technique, and is widely used because molecular diagnosis can be performed in a relatively fast time, but there is a problem in that multiple diagnosis is limited.

As a related prior art, Korean Patent Publication No. 10-2016-0020766 relates to a technique for absorbing multi-measurements for real-time molecular diagnosis, which performs measurement on a plurality of samples, enables temperature control and a simplified structure, thereby real-time measurement. While this possible measurement device is disclosed, only multiple measurements are possible in the measurement of absorbance, and other molecular diagnostic steps have limitations that cannot be performed individually or automated.

On the other hand, the paper molecular diagnosis technology is an isothermal amplification technology using the FTA card, it has the advantage that can perform the molecular diagnosis with a simple process of relatively low cost, but it is cumbersome to perform each step manually And, there is a problem such as the possibility of secondary infection through such a manual process.

Republic of Korea Patent Publication No. 10-2016-0020766

Therefore, the technical problem of the present invention has been conceived in this regard, the object of the present invention is a molecular diagnostic technology using paper, which can be automated from pre-treatment to measurement, multiple molecular diagnostics, and can be manufactured in multiple portable or small A molecular diagnostic system.

Multi-molecular diagnostic system according to an embodiment for realizing the object of the present invention includes a card unit, collecting unit, washing unit, reagent unit, heating unit and optical unit. The card portion is moved on a rotating frame and partitioned into a plurality of regions. The collecting unit provides the collected blood to respective areas of the card unit. The cleaning unit provides a cleaning liquid to the card unit to clean the blood collected in the card unit. The reagent unit provides a plurality of diagnostic reagents respectively to respective regions of the card portion. The heating unit copies the virus by heating the card unit in which the reagent is absorbed. The optical unit observes the replicated virus. The card portion sequentially moves to the collecting portion, the washing portion, the reagent unit, the heating portion, and the optical unit.

In one embodiment, the lower portion of the collecting portion, the blood absorbing portion for absorbing the blood passing through the card portion, the lower portion of the cleaning portion, the cleaning liquid absorbing portion for absorbing the cleaning liquid passing through the card portion, and the lower portion of the reagent unit In at, the card portion may further comprise a reagent absorbing portion for absorbing the reagents passing through.

In one embodiment, the card portion may be in close contact between the collecting portion and the blood absorbing portion, between the cleaning portion and the cleaning liquid absorbing portion, the reagent unit and the reagent absorbing portion.

In one embodiment, the card portion is fixed to the rotation frame, the rotation frame may be rotated about a central axis.

In one embodiment, as the rotating frame is rotated, the card portion may be located at the lower portion of the collecting portion, the cleaning portion, the reagent unit and the heating unit, respectively.

In one embodiment, the partition portion for partitioning a plurality of areas of the card portion may include a wax (wax), can block the penetration of blood in the adjacent area.

In one embodiment, the collecting unit may receive blood from a tube unit connected to the upper portion to provide separate blood to each of the regions of the card unit.

In an embodiment, the collecting part may include a plurality of needle parts positioned in the respective areas.

In one embodiment, the collecting unit may include a plurality of collecting conduits positioned in the respective regions to connect the tube portion and each of the regions.

In one embodiment, the reagent unit may include a plurality of reagent conduits positioned in respective regions of the card portion to provide different reagents to the respective regions.

In one embodiment, the card portion may be an FTA Card.

In one embodiment, the size and density of the pores of the card portion may be changed to control the passage speed of the blood, the cleaning solution, and the diagnostic reagents.

According to the embodiments of the present invention, in the case of the conventional paper molecular diagnosis, by implementing a manual process of each process manually implemented in a single automated system, a series of processes can be automatically performed to perform molecular diagnostics, usability and Convenience can be improved.

In addition, the unit for rotating the card portion on the rotation frame, and performing the respective diagnostic process is configured to be rotated, it is possible to minimize the volume of the entire diagnostic system, improve portability and can be made compact.

In particular, the other diagnostic units have a structure in which only the rotating frame on which the paper is located is rotated while the position is fixed, which is simple in structure and can improve diagnostic speed, and has a structure that is easy to manufacture.

In addition, as the diagnostic process is performed in the sealed interior, it is possible to minimize the problem of secondary infection in the conventional paper molecular diagnosis.

In addition, a unit for providing blood, a cleaning liquid or a diagnostic reagent is located at the upper part of the card unit, and an absorbing unit for absorbing blood, the cleaning liquid or a diagnostic reagent is located at the lower part of the card unit. It is possible to improve the efficiency of the diagnostic process by inducing the passage of liquid.

In addition, the card portion is partitioned into a plurality of regions by the partition portion, and as the penetration of adjacent blood is blocked, multiple molecular diagnosis can be performed through different diagnostic reagents in the plurality of regions.

1 is a perspective view showing a multi-molecular diagnostic system according to an embodiment of the present invention.
2 is an exploded perspective view of the multi-molecular diagnostic system of FIG.
3 is a plan view illustrating the card unit of FIG. 1.
4 is a perspective view illustrating the collecting part, the tube part, and the first absorbing part of FIG. 1.
5 is a perspective view illustrating a reagent unit and a fourth absorbing part of FIG. 1.
6 is a perspective view illustrating a collecting part, a tube part, and a first absorbing part in a multi-molecular diagnostic system according to another exemplary embodiment of the present invention.

As the inventive concept allows for various changes and numerous modifications, the embodiments will be described in detail in the text. However, this is not intended to limit the present invention to a specific disclosed form, it should be understood to include all modifications, equivalents, and substitutes included in the spirit and scope of the present invention. In describing the drawings, similar reference numerals are used for similar elements. Terms such as first and second may be used to describe various components, but the components should not be limited by the terms.

The terms are used only for the purpose of distinguishing one component from another. The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting of the present invention. Singular expressions include plural expressions unless the context clearly indicates otherwise.

In this application, the terms "comprise" or "consist of" are intended to indicate that there is a feature, number, step, operation, component, part, or combination thereof described in the specification, and one or more other features. It is to be understood that the present invention does not exclude the possibility of the presence or the addition of numbers, steps, operations, components, parts, or combinations thereof.

Unless defined otherwise, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art. Terms such as those defined in the commonly used dictionaries should be construed as having meanings consistent with the meanings in the context of the related art and shall not be construed in ideal or excessively formal meanings unless expressly defined in this application. Do not.

Hereinafter, with reference to the accompanying drawings, it will be described in detail a preferred embodiment of the present invention.

1 is a perspective view showing a multi-molecular diagnostic system according to an embodiment of the present invention. 2 is an exploded perspective view of the multi-molecular diagnostic system of FIG. 3 is a plan view illustrating the card unit of FIG. 1. 4 is a perspective view illustrating the collecting part, the tube part, and the first absorbing part of FIG. 1. 5 is a perspective view illustrating a reagent unit and a fourth absorbing part of FIG. 1.

1 to 5, the multi-molecular diagnostic system 10 according to the present embodiment includes an outer frame 20, a rotating frame 100, a card unit 200, a collecting unit 300, and a blood absorbing unit ( 350, the first cleaning unit 400, the first cleaning liquid absorbing unit 450, the second cleaning unit 500, the second cleaning liquid absorbing unit 550, the reagent unit 600, the reagent absorbing unit 650, and the like. It includes a heating unit 700, and although not shown may further include an optical unit.

As illustrated, the outer frame 20 may have a rectangular block shape, may be changed in design into various shapes, may have a cylindrical shape, and a predetermined space is formed therein, and the unit described later in the space Are located.

In addition, when the molecular diagnosis is performed, the outer frame 20 may be sealed with the outside to prevent contamination during molecular diagnosis, and the top or side may be opened before or after performing the molecular diagnosis. Can be.

On the other hand, in the present embodiment, the multi-molecular diagnostic system 10 is used as a single-use, portable or mobile, it can be manufactured relatively small.

The rotating frame 100 is located at the center of the inner space of the outer frame 20, and rotates about the central axis 101. The rotating frame 100 has a circular plate shape as shown, may be manufactured to a predetermined thickness, and the card portion 200 is located on one side.

Thus, as the rotation frame 100 rotates about the central axis 101, the card unit 200 is also rotated, and the card unit 200 is the collecting unit 300, which is described later, Located at the lower portions of the first and second cleaning parts 400 and 500, the reagent unit 600, and the heating part 700, respective processes for molecular diagnosis are performed.

Accordingly, the collecting part 300, the first and second cleaning parts 400 and 500, the reagent unit 600, and the heating part 700 are formed along the edge side of the rotating frame 100. The card parts 200 are aligned with the positions where the card parts 200 are positioned, and are positioned in a fixed state.

In this case, the collecting part 300, the first and second cleaning parts 400 and 500, the reagent unit 600 and the heating part 700 may be spaced apart by the same circumferential length, respectively. For example, each process may be spaced apart by a different circumference, taking into account each process, which is a design change.

However, in consideration of the process of molecular diagnosis, if the rotating frame 100 rotates in a counterclockwise direction as shown, the collecting part 300, the first and second cleaning parts 400, 500, The reagent unit 600 and the heating part 700 should be arranged in the counterclockwise order.

In addition, one side edge of the rotating frame 100 is formed with a space in which the card portion 200 can be located, the card portion 200 is located in the space to rotate.

The card unit 200 is an object in which a virus is detected as isothermally amplified in a state where blood and a diagnostic reagent penetrate, and as shown in FIG. 3, may have a circular paper shape having a predetermined thickness.

For example, the card unit 200 may be a Whatman FTA card used for conventional paper molecular diagnosis.

In addition, the card unit 200 has a structure in which pores are formed therein to allow blood, a diagnostic reagent, or a cleaning solution to pass therethrough, and sizes and densities of pores of the card unit may be variously formed. This may control the passage rate of the blood, the cleaning solution and the diagnostic reagent.

In this case, the card unit 200 is divided into a plurality of first to ninth regions 201, 202, ..., 209, a to i, and will be described later in each region, but different diagnostic reagents may be provided. It is provided through the one card unit 200 can perform a multi-molecular diagnostics through one molecular diagnostic process.

Of course, the number of regions formed in the card unit 200 may be variously set in consideration of the necessity of performing molecular diagnosis.

However, in this embodiment, in order to prevent blood or diagnostic reagent from penetrating into the areas adjacent to each other, a partition 210 is formed, the partition 210 is, for example, wax that prevents the penetration of liquid (wax) can be formed.

Unlike this, although not shown, the card portion 200 may be manufactured in the form of FIG. 3 in a form separated from each other, rather than one circular paper, to prevent penetration of blood or a diagnostic reagent from adjacent regions.

The card unit 200 is initially positioned below the collecting unit 300 to receive blood from the collecting unit 300.

As shown in detail in FIGS. 2 and 4, the collecting part 300 includes a collecting part cover 310 and a plurality of needles, and an upper part of the collecting part 300 includes a tube part 360. Is combined.

For example, the tube part 360 stores blood 361 extracted from the human body as an EDTA tube, and in this embodiment, the upper side of the collecting part 300 may be inserted into the EDTA tube as it is. It may be formed to match the shape and size of the end of the EDTA Tube.

Thus, when the tube part 360 in which blood is stored is coupled to the collecting part 300, the blood is supplied to the card part 200 through the collecting part 300.

In this case, a plurality of needles are arranged in the collecting part 300, and each of the plurality of needles, for example, the first to ninth needles 301, 302,. One by one in the first to ninth regions a to i of 200.

In addition, the upper ends of the plurality of needles may be pointed to penetrate the inside of the tube portion 360, through which the blood inside the tube portion 360 is lower than each of the card portion 200 Provided by the areas of.

On the other hand, in the present embodiment, when the card unit 200 is aligned with the collecting unit 300, the blood absorbing unit arranged in a line with the collecting unit 300 in the lower portion of the card unit 200 350 is located.

In addition, the card unit 200 is in close contact with the blood absorbing unit 350, and thus the blood provided to the card unit 200 is absorbed by the blood absorbing unit 350, through which the card unit In 200, blood passes.

In particular, in the present embodiment, in the process of the blood is absorbed by the card unit 200 through the card unit 200, the blood is dropped by gravity and absorbed by the blood absorbing unit 350, so Driving force is unnecessary, and thus a separate driving unit can be omitted. The separate driving unit may be omitted in the same manner in the cleaning solution and the reagent absorbing process of the first and second cleaning solution absorbing units 450 and 550 and the reagent absorbing unit 650 which will be described later.

As such, when blood is absorbed in the respective areas of the card unit 200, the rotating frame 100 is rotated, and thus the card unit 200 is disposed below the first cleaning unit 400. Will be located.

As illustrated, the first cleaning unit 400 may have a cylindrical shape having the same shape and area as the card unit 200, and therein, for cleaning the blood absorbed by the card unit 200. The cleaning liquid is contained.

In addition, when the card unit 200 is aligned with the first cleaning unit 400, the first cleaning liquid absorbing unit 450 may be disposed below the card unit 200. ) In line with In addition, the first cleaning solution absorbing part 450 is also positioned in close contact with the card part 200.

Thus, the cleaning liquid provided from the first cleaning unit 400 passes through the card unit 200 and is absorbed by the first cleaning liquid absorbing unit 450, and thus the blood that has been absorbed by the card unit 200. Is primarily washed.

Similarly, after the card part 200 is cleaned by the first cleaning part 400, the card part 200 is positioned below the second cleaning part 500 according to the rotation of the rotating frame 100.

As shown in the drawing, the second cleaning part 500 may have a cylindrical shape having the same shape and area as the card part 200, and therein, to clean the blood absorbed by the card part 200. For cleaning solution.

In this case, the cleaning solution of the second cleaning unit 500 may be different from the cleaning solution of the first cleaning unit 400, and included in the blood through the first and second cleaning units 400 and 500. The contents of plasma and the like, except the virus, are washed.

In addition, the number of the cleaning unit may be variously selected as necessary.

On the other hand, when the card unit 200 is aligned with the second cleaning unit 500, the second cleaning liquid absorbing unit 550 is disposed under the card unit 200. ) In line with In addition, the second cleaning liquid absorbing part 550 is also located in close contact with the card part 200.

Thus, the cleaning liquid provided from the second cleaning unit 500 passes through the card unit 200 and is absorbed by the second cleaning liquid absorbing unit 550, and thus the blood that has been absorbed by the card unit 200. Is further washed.

As described above, when the card unit 200 is cleaned through the first and second cleaning units 400 and 500, substantially only a virus such as DNA or RNA is present in the blood absorbed by the card unit 200. Will remain.

Thus, the rotation frame 100 is further rotated, so that the card portion 200 is located below the reagent unit 600.

Similarly, when the card unit 200 is positioned below the reagent unit 600, the reagent absorbing unit 650 aligned with the reagent unit 600 closely adheres to the bottom surface of the card unit 200. Done.

In this case, the reagent unit 600, as shown in Figure 5, comprises a unit cover 610 and a plurality of reagent conduits, the reagent conduits, for example, the first to ninth reagent conduits (601, 602, ..., 609).

Thus, each of the reagent conduits 601, 602,..., 609 is positioned one by one in the first to ninth regions a to i of the card portion 200.

Each of the reagent conduits 601, 602,..., 609 includes different types of diagnostic reagents, and is opened when the card unit 200 is located at a lower portion thereof to open the card unit 200. Respective reagents of different kinds are individually provided in each of the first to ninth regions a to i.

The reagents are introduced into each of the reagent conduits in advance to determine the presence of viruses or pathogens contained in the blood.

In addition, the respective areas of the card unit 200 are partitioned from each other by the partition unit 210, and thus, different reagents are blocked from penetrating into different areas, and are provided only to the corresponding areas. The necessary diagnosis can be performed for the virus.

In addition, reagents provided from each of the reagent conduits 601, 602,..., 609 are absorbed through the reagent absorbing portion 650 in close contact with the bottom surface of the card portion 200.

As such, in a state in which different diagnostic reagents are absorbed in respective regions of the card unit 200 in which only viruses remain, the card unit 200 is rotated and positioned under the heating unit 700. .

In this case, an additional absorbing part 750 may be disposed below the heating part 700 in a line with the heating part 700, and the additional absorbing part 750 may be disposed on a lower surface of the card part 200. In close contact, it can further absorb impurities which evaporate or occur during drying through heating.

The heating unit 700 heats the respective regions of the card unit 200, thereby amplifying the virus remaining in the card unit 200. That is, through the virus amplification through the heating unit 700, it is possible to diagnose the virus through the optical unit.

On the other hand, although not shown, a separate optical unit may be positioned to be adjacent to the heating unit 700, or may be guided to the inside of the outer frame 20 from the outside.

Thus, through the optical unit, virus detection is performed on respective areas of the card unit 200 which are partitioned from each other. That is, a region where a reaction occurs with respect to the reagents, for example, a region expressed in fluorescent colors, can be detected through the optical unit, thereby determining the presence of viruses or pathogens finally included in the blood. have.

As described above, a series of molecular diagnostics for viruses or pathogens in the blood can be automatically and rapidly progressed through the above-described multi-molecular diagnostic system. Multi-molecular diagnostics is enabled.

6 is a perspective view illustrating a collecting part, a tube part, and a first absorbing part in a multi-molecular diagnostic system according to another exemplary embodiment of the present invention.

Since the multi-molecular diagnostic system according to the present embodiment is substantially the same as the multi-molecular diagnostic system described with reference to FIGS. 1 to 5 except for the shape and structure of the collecting unit 320, the same reference numerals are used for the same components. And duplicate descriptions are omitted.

Referring to FIG. 6, in the multi-molecular diagnostic system according to the present embodiment, the collecting part 320 has a cylindrical shape as a whole and a plurality of collecting conduits are formed inside the outer shape 330.

The collection conduits may be, for example, first to ninth collection conduits 321, 322,..., 329, and each collection conduit may have a shape of a conduit penetrating the inside of the contour 330. Has

In addition, each of the collection conduits 321, 322,..., And 329 may be individually positioned in the first to ninth regions a to i. In addition, the tube portion 360 is coupled to the upper portion of the collecting portion 320, the tube portion 360 may be an EDTA tube in which blood 361 is stored as described above, and thus the collecting portion 320 ) May be formed to have a shape and size into which the EDTA tube can be inserted.

Thus, when the tube part 360 is coupled to the collecting part 320, the tube part 360 is divided into each other through the respective collecting conduits 321, 322,..., 329 of the collecting part 320. Blood is provided to the regions a-i.

In this case, when the card unit 200 is aligned with the collecting unit 320, the blood absorbing unit 350 arranged in line with the collecting unit 320 is disposed below the card unit 200. Positioning is as described above, and thus the blood provided to the card unit 200 is absorbed by the blood absorbing unit 350 through which blood passes through the card unit 200.

According to the embodiments of the present invention as described above, in the case of the conventional paper molecular diagnostics, it is possible to implement molecular diagnostics by automatically performing a series of processes by implementing each process manually in one automated system , Usability and convenience can be improved.

In addition, the unit for rotating the card portion on the rotation frame, and performing the respective diagnostic process is configured to be rotated, it is possible to minimize the volume of the entire diagnostic system, improve portability and can be made compact.

In particular, the other diagnostic units have a structure in which only the rotating frame on which the paper is located is rotated while the position is fixed, which is simple in structure and can improve diagnostic speed, and has a structure that is easy to manufacture.

In addition, as the diagnostic process is performed in the sealed interior, it is possible to minimize the problem of secondary infection in the conventional paper molecular diagnosis.

In addition, a unit for providing blood, a cleaning liquid or a diagnostic reagent is located at the upper part of the card unit, and an absorbing unit for absorbing blood, the cleaning liquid or a diagnostic reagent is located at the lower part of the card unit. It is possible to improve the efficiency of the diagnostic process by inducing the passage of liquid.

In addition, the card portion is partitioned into a plurality of regions by the partition portion, and as the penetration of adjacent blood is blocked, multiple molecular diagnosis can be performed through different diagnostic reagents in the plurality of regions.

While the foregoing has been described with reference to preferred embodiments of the present invention, those skilled in the art will be able to variously modify and change the present invention without departing from the spirit and scope of the invention as set forth in the claims below. It will be appreciated.

The small multi-molecular diagnostic system according to the present invention has industrial applicability that can be used as a molecular diagnostic device.

10: Multi-molecular diagnostic system 20: External frame
100: rotation frame 200: card portion
300, 320: collecting unit 350: blood absorbing unit
360: tube part 400: first cleaning part
450: washing liquid absorbing portion 500 500: second washing portion
550: second cleaning liquid absorption unit 600: reagent unit
650: reagent absorbing part 700: heating part
750: additional absorption

Claims (12)

A card portion moved on the rotating frame and partitioned into a plurality of regions;
A collecting unit for providing the collected blood to respective regions of the card unit;
A cleaning unit for cleaning the blood collected in the card unit by providing a cleaning liquid to the card unit;
A reagent unit each providing a plurality of diagnostic reagents to respective regions of the card portion;
A heating unit for replicating a virus by heating the card portion in which the reagent is absorbed; And
It includes an optical unit for observing the replicated virus,
And the card portion sequentially moves to the collecting portion, the washing portion, the reagent unit, the heating portion, and the optical unit. The method of claim 1,
A blood absorbing part for absorbing blood passing through the card part from a lower portion of the collecting part;
A washing liquid absorbing unit absorbing the washing liquid passing through the card unit under the washing unit; And
At the bottom of the reagent unit, further comprising a reagent absorbing portion for absorbing the reagents passing through the card portion. The method of claim 2, wherein the card unit,
And a close contact between the collecting part and the blood absorbing part, between the cleaning part and the cleaning liquid absorbing part, between the reagent unit and the reagent absorbing part. The method of claim 1,
The card unit is fixed to the rotating frame, the rotary frame is a multi-molecular diagnostic system, characterized in that for rotating around a central axis. The method of claim 4, wherein
And the card unit is positioned below the collecting unit, the cleaning unit, the reagent unit, and the heating unit as the rotating frame is rotated. The method of claim 1,
And a partition portion for partitioning the plurality of regions of the card portion, including wax, to block the penetration of blood from adjacent regions. The method of claim 1, wherein the collecting unit,
Receiving blood from the tube portion connected to the upper multi-molecular diagnostic system, characterized in that to provide a separate blood to each of the regions of the card portion. The method of claim 7, wherein the collecting unit,
And a plurality of needle portions respectively positioned in the respective regions. The method of claim 7, wherein the collecting unit,
And a plurality of collecting conduits positioned in said respective regions and connecting said tube portion and each of said regions. The method of claim 1, wherein the reagent unit,
And a plurality of reagent conduits positioned in respective regions of the card portion to provide different reagents to the respective regions. The method of claim 1,
The card unit is a multi-molecular diagnostic system, characterized in that the FTA Card. The method of claim 1,
And varying the size and density of pores of the card portion to control the passage speed of the blood, the cleaning liquid and the diagnostic reagents.

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