Genome amplification module with branch space adjacent to extract inlet

Abstract

The present invention relates to a genome amplification module having a branch space adjacent to an inlet through which an extract is introduced, in which a branch space is formed in a portion adjacent to the inlet, the branch space being wider and deeper than an extract movement path, the branch spaces are arranged such that after the extract is filled into the branch spaces, the extract can be injected simultaneously along each extract movement path.

Description

Technical Field

[0001] The present invention relates to a genome amplification module having a branching space adjacent to an inlet through which an extract is introduced. Background Art

[0002] In modern times, with the development of biotechnology, it is possible to explain the causes of diseases at the genetic level. As a result, there is an increasing demand for the manipulation and biochemical analysis of biological samples for the treatment or prevention of human diseases.

[0003] Furthermore, techniques for extracting and analyzing nucleic acids from biological samples or samples containing cells are required in a variety of different fields, such as new drug development in addition to disease diagnosis, preliminary testing for viral or bacterial infections, and forensics.

[0004] Meanwhile, Korean registered patent registration number 10-2362853 discloses an extraction device for preparing an extract containing a genome by pre-treating an injected sample, which is a device developed by the present applicant. The extract produced by the extraction device is moved to an amplification module connected to the extraction device, and the extract injected into the receiving chamber of the amplification module is amplified by a nucleic acid amplification reaction. A probe that specifically binds to a target / target sequence and contains a fluorescent substance is stored in the receiving chamber, so that when the target sequence is included in the genome of the extract, fluorescence can be observed by the nucleic acid amplification reaction. In addition, depending on whether fluorescence is observed, it can be determined whether the individual from whom the sample was collected is infected with a disease / virus.

[0005] Meanwhile, in the case where the amplification module has multiple containing chambers, each containing chamber may store primers / probes for detecting different targets. When the extracts injected into multiple containing chambers are mixed during the injection / amplification process, inaccurate detection results will be obtained. In addition, in order to ensure that the results are relatively consistent, the same amount of extract needs to be injected into each containing chamber; however, in traditional genome amplification modules, a larger amount of extract is usually injected into the containing chamber that is relatively less affected by gravity.

[0006] Therefore, the inventors of the present invention designed and completed the present invention to solve the problems of such conventional genome amplification modules according to the related art.

[0007] (Patent Document 1) Korean registered patent KR 10-2346703 (December 29, 2021)

[0008] (Patent Document 2) Korean registered patent KR 10-2416335 (June 29, 2022)

[0009] (Patent Document 3) Korean registered patent KR 10-2293717 (August 19, 2021)

[0010] (Patent Document 4) Korean registered patent KR 10-2375252 (March 11, 2022)

[0011] (Patent Document 5) Korean registered patent KR 10-2362853 (February 9, 2022) Summary of the invention

[0012] Technical issues

[0013] According to the present invention, a genome extraction device is provided, in which an inner chamber containing reagents required for genome extraction is separately arranged from an outer chamber, and the genome extraction device is able to solve the problem of reagents contained in a single chamber in a genome extraction device according to the related art leaking to the outside because the upper part and the lower part of the inner chamber are sealed and isolated.

[0014] The present invention also provides a genome extraction device, which includes a safety clip for preventing sealing members sealing the upper opening and the lower opening of the inner chamber from being pierced by protruding members formed in the cover and the outer chamber because the inner chamber moves up and down due to vibrations generated during the production and distribution process of the product.

[0015] The present invention also provides a genome extraction device which solves the problem of cross-contamination between reagents due to capillary action occurring through the space between the double chambers through a unique inner chamber design (lower inner chamber).

[0016] The present invention also provides a genome extraction device that solves the problem of reagent leakage to the outside through a unique inner chamber design (upper inner chamber) in a structure for preventing capillary action.

[0017] The present invention also provides a genome extraction device, in which, due to the configuration of the first protrusion member formed on the bottom surface of the outer chamber, the sealing member can be torn with a smaller force and the pierced part is expanded, so that the reagent contained in the inner chamber can be smoothly discharged to the outside.

[0018] The present invention also provides a genome extraction device, in which an inclined portion is formed around a discharge hole through which a reagent is discharged, so that the reagent can be discharged smoothly through the discharge hole.

[0019] The present invention also provides a genome extraction device, in which a double-structured flow cover-gasket is arranged between an outer chamber and a substrate, thereby improving the manufacturing convenience and solving the problem of accidental narrowing of the flow path compared to a genome extraction device according to the related art in which only one gasket is arranged.

[0020] The present invention also provides a genome extraction device, in which a firm connection is achieved between the substrate, the flow cover, the gasket and the outer chamber, so that a sealed flow path is formed, and there is no phenomenon that the reagent will flow out from the middle during the reagent movement process.

[0021] The present invention also provides a genome extraction device, in which a microbead chamber that accommodates microbeads required for genome extraction and amplification also has a dual-chamber structure of an outer chamber and a microbead chamber, thereby maintaining the performance of microbeads that are susceptible to moisture for a long time.

[0022] The present invention also provides a genome extraction device in which the performance of microbeads is maintained by a dehumidification portion located above the microbead chamber even when the microbead chamber is opened.

[0023] The present invention also provides a genome extraction device, in which, as the pretreated extract is injected, the air remaining inside the containing chamber can be easily discharged, so that an amplification module that can inject a sufficient volume of extract can be applied to the genome extraction device.

[0024] The present invention also provides a genome extraction device, in which an amplification module has multiple accommodating chambers, and primers and probes for amplifying different genomes are stored in each accommodating chamber, so that multiple types of diseases can be diagnosed through a single genome extraction.

[0025] The present invention also provides a genome amplification module, in which multiple extract movement paths have the same capacity (volume), so that the extract can be injected into all the containing chambers at the same time, and the same amount of extract can be injected.

[0026] The present invention also provides a genome amplification module, in which a branch space is formed in a portion adjacent to an inlet, and the branch space is wider and deeper than the extract movement path, so that after the branch space is filled with the extract, the extract can be injected along each extract movement path at the same time.

[0027] The present invention also provides a genome amplification module, in which a branch space is formed at a first end adjacent to an inlet, and a accommodating cavity is arranged at a second end away from the first end, so that the amplification product in each accommodating cavity can be prevented from being pushed out to a moving path or flowing back to another accommodating cavity by the heated temperature during the amplification process.

[0028] The present invention also provides a genome amplification module, in which a space wider and deeper than other parts is formed at the connection point between the gas movement passage and the containing chamber, so that even if bubbles are generated, it will not affect the containing chamber, thereby improving the detection accuracy.

[0029] The present invention also provides a genome amplification module in which the width and depth of the gas movement passage are set to be minimum, thereby minimizing the extract discharged through the gas movement passage.

[0030] The present invention also provides a genome extraction method using the genome extraction device.

[0031] Technical Solution

[0032] According to one aspect of the present invention, an amplification module is provided, which includes a main body, an inlet formed in the main body and through which an extract is introduced, a plurality of accommodating chambers connected to the inlet and accommodating the introduced extracts, a first branch space communicated with the inlet, a plurality of extract movement passages branching from the first branch space and connecting the inlet and the plurality of accommodating chambers to each other, an outlet formed in the main body and through which gas is discharged, and a plurality of gas movement passages connecting the outlet and the plurality of accommodating chambers to each other.

[0033] The first branch space may include a first penetration portion penetrating the body and connected to the inlet, and a first recessed portion formed between the first penetration portion and the plurality of extract movement paths and recessed in one surface of the body.

[0034] At least one of a width and a depth of the first branch space is wider or deeper than a width and a depth of the extract movement path.

[0035] The volumes of the plurality of extract moving passages may all be the same.

[0036] The first branch space may be formed at a first end of the amplification module in the width direction, and the plurality of accommodation cavities may be formed at a second end of the amplification module opposite to the first end in the width direction.

[0037] The amplification module may also include a second branch space formed between the outlet and the multiple gas movement passages, wherein the second branch space includes a second penetration portion and a second recessed portion, the second penetration portion penetrates the main body and is connected to the outlet, and the second recessed portion is formed between the second penetration portion and the multiple gas movement passages and is recessed in another surface of the main body.

[0038] The first recessed portion and the second recessed portion may have a portion in which the first recessed portion and the second recessed portion partially overlap in a width direction of the body and are recessed in the body.

[0039] The amplification module may also include a sealing member attached to a surface of the main body and a surface opposite to the one surface, and configured to seal and separate multiple accommodating chambers, a first branch space, a second branch space, an extract movement passage, and a gas movement passage from the external space.

[0040] The space between the first recessed portion and the sealing member and the space between the second recessed portion and the second sealing member may not communicate with each other.

[0041] The gas moving passage may be connected to an upper portion of the accommodation chamber, and the gas moving passage may be formed with a space wider and deeper than other portions at a connection point of the gas moving passage and the accommodation chamber.

[0042] At least one of a width and a depth of the gas movement passage is narrower or shallower than a width and a depth of the extract movement passage.

[0043] The gas movement passage can be formed by a combination of one or more of the following items: a first gas movement passage having a first width and a first depth, a second gas movement passage having a first depth and a second width greater than the first width, and a third gas movement passage having a third width greater than the second width and a second depth greater than the first depth.

[0044] The plurality of columnar portions may protrude from the gas movement passage.

[0045] The gas movement passages connected to the plurality of accommodation chambers may have the same capacity.

[0046] Probes and primers for amplifying a first target substance may be stored in one of the plurality of receiving chambers, and probes and primers for amplifying a second target substance different from the first target substance may be stored in another receiving chamber.

[0047] Beneficial effects

[0048] In the genome extraction device according to the present invention, the inner chamber containing the reagents required for genome extraction is arranged separately from the outer chamber, and the upper and lower parts of the inner chamber are sealed and separated, thereby solving the problem of leakage of reagents contained in a single chamber of the genome extraction device according to the related art.

[0049] Furthermore, the inner chamber moves up and down due to vibrations generated during the production and distribution process of the product, thereby preventing sealing members for sealing the upper and lower openings of the inner chamber from being pierced by protruding members formed in the cover and the outer chamber.

[0050] Furthermore, the problem of cross contamination between reagents due to capillary action occurring through the space between the dual chambers can be solved.

[0051] Furthermore, in the structure for preventing the capillary action, the reagent can be prevented from leaking out.

[0052] Furthermore, due to the configuration of the first protruding member formed on the bottom surface of the outer chamber, the sealing member can be torn even with a small force, and the pierced portion is expanded, so that the reagent contained in the inner chamber leaks smoothly to the outside.

[0053] Furthermore, an inclined portion is formed around the discharge hole through which the reagent is discharged, so that the reagent can be smoothly discharged through the discharge hole.

[0054] In addition, by arranging a double-structured flow cover-liner between the outer chamber and the substrate, the manufacturing convenience is improved compared to the genome extraction device according to the related art in which only one liner is provided, and the problem of inadvertently narrowing the flow path is solved.

[0055] Furthermore, a secure connection between the base plate, the flow cover, the gasket and the outer chamber is achieved, thereby forming a sealed flow path without leakage from the middle during the movement of the reagent.

[0056] In addition, the microbead chamber that accommodates the microbeads required for genome extraction and amplification also has a dual-chamber structure of an outer chamber-microbead chamber, so that the performance of the microbeads that are easily affected by moisture can be maintained for a long time.

[0057] Even if the microbead chamber is opened, the performance of the microbeads is maintained by the dehumidification unit located at the upper portion of the microbead chamber.

[0058] When the pretreated extract is injected, the air remaining inside the containing chamber is easily discharged, thereby injecting a sufficient volume of the extract into the amplification module.

[0059] Furthermore, the amplification module has a plurality of accommodating chambers, and primers and probes for amplifying different genomes are stored in each accommodating chamber, so that multiple types of diseases can be diagnosed through a single genome extraction.

[0060] Furthermore, the plurality of extract movement passages have the same capacity (volume), so that the extract can be injected into all the accommodation chambers at the same time, and the same amount of the extract can be injected.

[0061] Furthermore, a branch space is formed in a portion adjacent to the inlet, the branch space being wider and deeper than the extract moving passage, so that after the branch space is filled with the extract, the extract can be injected along each extract moving passage at the same time.

[0062] In addition, a branch space is formed in the first end adjacent to the inlet, and a receiving chamber is provided at the second end away from the first end, so that the amplification product in each receiving chamber can be prevented from being pushed out to the moving path or flowing back to another receiving chamber by the heated temperature during the amplification process.

[0063] In addition, a space is formed at the connection point between the gas movement passage and the accommodating chamber, and the space is wider and deeper than other parts, so that even if bubbles are generated, the bubbles will not affect the accommodating chamber, thereby improving the detection accuracy.

[0064] Furthermore, the width and depth of the gas moving passage are set to a minimum so that the extract discharged through the gas moving passage is minimized. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 is a perspective view showing the overall appearance of a genome extraction apparatus according to an embodiment of the present invention;

[0066] Figure 2 Observed from another angle Figure 1 A perspective view of a genome extraction device;

[0067] Figure 3 yes Figure 1 Exploded perspective view in;

[0068] Figure 4 is a view showing a coupling relationship between an outer chamber and an inner chamber;

[0069] Figure 5 is a view showing the coupling relationship between the inner chamber and the safety clip;

[0070] Figure 6 is a plan view of the outer chamber;

[0071] Figure 7 is a cross-sectional view showing the coupling relationship between the inner chamber and the outer chamber;

[0072] Figure 8 is an enlarged view showing a second protrusion member formed on the bottom surface of the outer chamber;

[0073] Fig. 9 is a view showing the inner chamber in more detail;

[0074] Fig.10 is a bottom perspective view showing the cover in more detail;

[0075] Fig.11 is an exploded perspective view showing in greater detail a flow cover and a liner disposed between a base plate and an outer chamber;

[0076] Fig.12is an exploded perspective view showing the configuration of the piston in detail;

[0077] Fig.13 is a bottom perspective view of the flow cover;

[0078] Fig.14 is a perspective view showing the base plate in more detail;

[0079] Fig.15 is a cross-sectional view showing in detail a genome extraction apparatus according to an embodiment of the present invention;

[0080] Fig.16 is another cross-sectional view for illustrating in detail the genome extraction apparatus according to an embodiment of the present invention;

[0081] Figures 17 to 20 is a view showing an amplification module according to a first embodiment of the present invention;

[0082] Figure 21 to Figure 23 is a view showing an amplification module according to a second embodiment of the present invention;

[0083] Figure 24 to Figure 26 is a view showing an amplification module according to a third embodiment of the present invention;

[0084] Figure 27 to Figure 29 is a view showing an amplification module according to a fourth embodiment of the present invention;

[0085] Fig.30 is a plan view of the microbead chamber;

[0086] Fig.31 and Fig.32 is a perspective view showing the configuration of the microbead chamber in more detail;

[0087] Fig.33 yes Fig.31 a transverse cross-sectional view of a microbead chamber; and

[0088] Fig.34 yes Fig.31 2 is a longitudinal cross-sectional view of a microbead chamber and is a view showing a structure in which the microbead chamber is combined with an outer chamber. DETAILED DESCRIPTION

[0089] In some cases, in order to avoid obscuring the concepts of the present invention, well-known structures and devices may be omitted or shown in block diagram form, thereby focusing on the core functions of each structure and device.

[0090] Throughout the specification, when a part is referred to as "comprising or including" a certain component, other components are not excluded unless otherwise specified, which means that other components may be further included. In addition, terms such as "... unit", "... group" and "module" described in the specification refer to a unit that processes at least one function or operation, which can be implemented as hardware or software or a combination of hardware and software. In addition, in the context of describing the present invention (especially in the context of the following claims), "one or an", "an", "the" and similar related words may be used to include singular and plural meanings, unless otherwise specified in this specification or clearly contradictory to the context.

[0091] When describing the embodiments of the present invention, if it is determined that the detailed description of a well-known function or configuration may unnecessarily confuse the main points of the present invention, the detailed description thereof will be omitted. Moreover, the terms to be described below are terms defined in consideration of the functions in the embodiments of the present invention, which may vary according to the intentions or habits of users and operators. Therefore, they should be defined based on the contents of the entire specification.

[0092] Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

[0093] refer to Figures 1 to 3 The genome extraction device 1000 according to an embodiment of the present invention includes an outer chamber 100, an inner chamber 200, a cover 300, a substrate 400, a safety clip 500, an amplification module 600, a piston 700, a driving unit 800 and a microbead chamber 900.

[0094] The outer chamber 100 is partitioned into a plurality of first spaces 101, 102, 103, 104, 105, 106, and 107 by the outer chamber partition wall. That is, the plurality of first spaces 101, 102, 103, 104, 105, 106, and 107 may be mutually independent spaces.

[0095] The plurality of first spaces 101, 102, 103, 104, 105, 106, and 107 may have an open upper portion and a closed lower portion. On the other hand, the first discharge holes 121, 122, 123, 124, and 125 are formed through the bottom surface of the plurality of first spaces 101, 102, 103, 104, and 105 in the circumferential direction while being spaced apart from the central portion of the outer chamber 100 by a first distance, and the second discharge holes 126 and 127 are formed through the bottom surface of the remaining first spaces 106 and 107 in the circumferential direction while being spaced apart from the central portion of the outer chamber 100 by a second distance. In addition, the discharge holes 128 and 129 communicating with the amplification module 600 are formed through the bottom surface of the space between the first spaces 106 and 107. Here, the first distance may be shorter than the second distance, but in another embodiment, the first distance may be longer than the second distance.

[0096] Reagents stored in the inner chamber 200 described later are placed in the plurality of first spaces 101 , 102 , 103 , 104 , and 105 , and beads stored in the bead chamber 900 are placed in the remaining first spaces 106 and 107 .

[0097] A piston insertion portion 108 into which the piston 700 is inserted is formed in a vertical direction through the centers of the plurality of first spaces 101, 102, 103, 104, 105, 106, and 107. The piston 700 is inserted into the piston insertion portion 108, and a driving unit (not shown) of a diagnostic apparatus is coupled to the piston 700 to raise the piston 700 so that reagents (fluids) in the first spaces 101, 102, 103, 104, 105, 106, and 107 can enter and leave the fluid containing chamber 701 inside the piston 700. More specific details will be described later.

[0098] Reference Figure 4 , the outer surface upper part 100a of the outer chamber 100 is recessed toward the central part of the outer chamber 100 while being connected to the upper part of the outer surface lower part 100b. The safety clip 500 can be coupled to the outer surface upper part 100a of the outer chamber 100, and the boundary between the outer surface upper part 100a and the outer surface lower part 100b serves as a step for the safety clip 500, thereby ensuring that once the safety clip 500 is coupled to the outer surface upper part 100a, its coupling position can be kept fixed. The safety clip 500 includes an outer chamber coupling part 510 and a handle 520, the outer chamber coupling part having a length extending to at least partially surround the outer surface upper part 100a of the outer chamber 100, and the handle is formed on one side of the outer chamber coupling part 510.

[0099] When the safety clip 500 is coupled to the outer chamber 100, the cover 300 presses the inner chamber 200 coupled to the outer chamber 100, so that the upper opening and the lower opening of the inner chamber 200 can be prevented from being opened. The user can start the extraction process after removing the safety clip 500 from the outer chamber 100 by grasping the handle 520. In other words, when the safety clip 500 is coupled to the outer chamber 100, the reagent in the inner chamber 200 is not introduced into the outer chamber 100. Only when the safety clip 500 is removed from the outer chamber 100, the reagent of the inner chamber 200 is introduced into the outer chamber 100.

[0100] Will refer to Figures 3 to 5 The configuration of the safety clip 500 is described in more detail.

[0101] The safety clip 500 includes an outer chamber coupling portion 510 , a handle 520 , an upper extension portion 530 , and a side extension portion 540 .

[0102] The outer chamber coupling portion 510 is coupled to the outer chamber 100 while at least partially surrounding the outer periphery (specifically, the outer surface upper portion 100a) of the outer chamber 100. More specifically, the outer chamber coupling portion 510 is coupled to the outer chamber 100 so as to surround the four outer surfaces of the outer chamber 100, and the extended ends of the outer chamber coupling portion 510 may be configured to be spaced apart from each other. Figure 1 As shown, when the safety clip 500 is connected to the outer chamber 100, the extended end of the outer chamber connecting part 510 is stuck on one of the outer surfaces of the outer chamber 100, so that the user needs to grasp the safety clip 500 and apply external force in one direction to separate the safety clip 500 from the outer chamber 100.

[0103] The handle 520 is a portion extending outward from the outer chamber coupling portion 510 , and is a portion grasped by a user to separate the safety clip 500 from the outer chamber 100 .

[0104] The upper extension portion 530 extends upward from one side of the outer chamber coupling portion 510 , and the side extension portion 540 extends from the upper extension portion 530 toward the center of the outer chamber 100 .

[0105] The safety clip 500 according to the embodiment of the present invention is characterized in that the cover support member 541 protrudes from the upper surface of the side extension part 540, and the inner chamber coupling part 542 protrudes from the extended end of the side extension part 540. Thus, the cover support member 541 prevents the protrusion members 311, 312, 313, 314, 315, 316 and 317 formed on the bottom surface of the cover 300 from tearing (piercing) the first sealing member S1 sealing the upper opening of the plurality of second spaces 201, 202, 203, 204 and 205 of the inner chamber 200 and the third sealing member S3 sealing the upper opening of the microbead chamber 900 when the safety clip 500 is coupled to the outer chamber 100.

[0106] Since the cover support member 541 protrudes upward from the upper surface of the side extension portion 540, as shown in FIG. Fig.15 As shown, when the safety clip 500 is coupled to the outer chamber 100 and the inner chamber 200, the contact between the protrusion members 311, 312, 313, 314, 315, 316 and 317, the first sealing member S1 and the third sealing member S3 is blocked. Therefore, when the safety clip 500 is coupled to the outer chamber 100 and the inner chamber 200, it prevents the inner chamber 200 and the microbead chamber 900 from being pierced. Therefore, it is possible to prevent the reagent contained in the inner chamber 200 and the microbeads contained in the microbead chamber 900 from leaking into the outer chamber 100.

[0107] When the safety clip 500 is coupled to the outer chamber 100, the inner chamber coupling portion 542 is a portion coupled to the fixing portion 230 of the inner chamber 200. When the inner chamber coupling portion 542 is coupled to the fixing portion 230, the bottom surface of the inner chamber 200 is located at a position spaced apart from the bottom surface of the outer chamber 100 by a predetermined distance. Therefore, the second sealing member S2 sealing the lower openings of the plurality of second spaces 201, 202, 203, 204, and 205 can be prevented from being torn by the protruding members 111, 112, 113, 114, and 115 formed on the bottom surface of the outer chamber 100 (see FIG. 1 ). Fig.15 ).

[0108] In the drawings, the inner chamber connecting portion 542 is shown in the form of a connecting protrusion, and the fixing portion 230 is shown in the form of a connecting groove engaged with the connecting protrusion, but in other embodiments, the inner chamber connecting portion 542 may be provided in the form of a connecting groove, and the fixing portion 230 may be provided in the form of a connecting protrusion connected to the connecting groove.

[0109] The mounting portion 109 providing a space in which the fixing portion 230 of the inner chamber 200 is mounted can be formed by being recessed in the outer chamber 100 (more specifically, the outer chamber partition wall). Although the inner chamber 200 is fixed at a position spaced a predetermined distance from the bottom surface of the outer chamber 100 by the coupling structure with the safety clip 100, since the fixing portion 230 of the inner chamber 200 is mounted on and supported by the mounting portion 109, the fixing force can be further increased.

[0110] Reference Figure 7 , the insertion space 130 is recessed at the upper side of the inner wall of the outer chamber 100, and the coupling hook 240 of the inner chamber 200 can be coupled to the insertion space 130. The stopper 131 protrudes from the upper side of the insertion space 130 toward the inside of the outer chamber 100. Therefore, when the inner chamber 200 is not pressed by the cover 300, the coupling hook 240 of the inner chamber 200 is located on the stopper 131, but when the inner chamber 200 is pressed by the cover 300, the coupling hook 240 can pass through the stopper 131 and be inserted into the insertion space 130.

[0111] Reference Fig.15 , the outer chamber-inner chamber connection relationship according to another embodiment of the present invention will be described. Figure 7 The coupling hook 240 formed in the inner chamber 200 is provided with a locking protrusion 250 protruding outward from the outer wall of the inner chamber 200, and the locking protrusion 250 is caught by a stopper formed in the inner wall of the outer chamber 100, thereby partially restricting the downward movement of the inner chamber 200. When the safety clip 500 is removed from the outer chamber 100 and the inner chamber 200 is pressed by the cover 300, the locking protrusion 250 passes through the stopper 131 and is inserted into the insertion space 130, and thus, the second sealing member S2 that seals the plurality of second spaces in the inner chamber 200 is pierced by the protruding member formed in the outer chamber 100.

[0112] The inner chamber 200 is partitioned into a plurality of second spaces 201, 202, 203, 204, and 205 by the inner chamber partition wall. That is, the plurality of second spaces 201, 202, 203, 204, and 205 may be mutually independent spaces.

[0113] The upper and lower parts of the plurality of second spaces 201, 202, 203, 204 and 205 are open (i.e., the plurality of second spaces have an upper opening and a lower opening), and the upper part is sealed by the first sealing member S1, and the lower part is sealed by the second sealing member S2. The first sealing member S1 and the second sealing member S2 can be, for example, a film, but the present invention is not limited thereto. The first sealing member can be made of any material that a fluid cannot pass through.

[0114] Different reagents can be injected into the plurality of second spaces 201, 202, 203, 204 and 205. The second sealing member S2 seals the lower portion of the plurality of second spaces, and then the reagent is injected. After the reagent is introduced, the first sealing member S1 seals the upper portion of the plurality of second spaces, thereby completing the injection of the reagent into the inner chamber 200.

[0115] Reference Figure 4 , the inner chamber 200 includes an upper inner chamber 210 and a lower inner chamber 220 .

[0116] The upper inner chamber 210 is integrally formed, and when the upper inner chamber 210 is coupled with the outer chamber 100 , the upper inner chamber 210 is configured to be in close contact with the inner wall of the outer chamber 100 .

[0117] The lower inner chamber 220 is connected to the upper inner chamber 210 and includes a bent portion (toward a radially inner direction) so as to be spaced apart from an inner wall of the outer chamber 100 when the lower inner chamber 220 is coupled with the outer chamber 100 .

[0118] Because the present invention uses a dual chamber structure including an inner chamber and an outer chamber, there may be a risk of cross contamination between reagents in the inner chamber 200 during operation. Cross contamination may occur via capillary action occurring through the micro space between the inner chamber and the outer chamber. In order to prevent the cross contamination problem, the present invention has a configuration in which the inner chamber 200 is fully separated and spaced apart from the inner wall of the outer chamber 100 by adopting a curved structure, thereby preventing such capillary phenomena.

[0119] Furthermore, in order to prevent the reagent from leaking out through the spacer portion between the outer chamber 100 and the inner chamber 200 for preventing capillary action, the upper inner chamber 210 is configured to be in close contact with the inner wall of the outer chamber 100 .

[0120] On the other hand, the first protrusion members 111, 112, 113, 114 and 115 protrude from the bottom surfaces of the multiple first spaces 101, 102, 103, 104 and 105, tearing the second sealing member S2 of the inner chamber 200, thereby allowing the reagent contained in the inner chamber 200 to leak into the multiple first spaces 101, 102, 103, 104 and 105.

[0121] Each of the first protrusion members 111, 112, 113, 114, and 115 may be arranged to correspond in a one-to-one correspondence to the plurality of first spaces 101, 102, 103, 104, and 105. For example, the first protrusion member corresponding to reference numeral 111 tears and seals the second sealing member S2 of the upper portion of the first space corresponding to reference numeral 101, and the first protrusion member corresponding to reference numeral 115 tears and seals the second sealing member S2 of the upper portion of the first space corresponding to reference numeral 105.

[0122] The first protrusion members 111, 112, 113, 114, and 115 include protrusions 111a, 112a, 113a, 114a, and 115a protruding a first height h1 from the bottom surfaces of the plurality of first spaces 101, 102, 103, 104, and 105, and wings 111b, 112b, 113b, 114b, and 115b extending from the protrusions 111a, 112a, 113a, 114a, and 115a and protruding from the bottom surfaces at a second height h2 lower than the first height h1. Here, the wings 111b, 112b, 113b, 114b, and 115b may have a structure extending in the left-right direction from the protrusions 111a, 112a, 113a, 114a, and 115a.

[0123] Each protrusion is used to pierce the second sealing member S2, and each wing is used to expand the piercing portion of the second sealing member S2. In the present invention, because the height of each protrusion is higher than the height of each wing, a point contact is formed between the second sealing member S2 and each protrusion for sealing the lower part of the inner chamber 200, and through this point contact, when the second sealing member S2 is torn, there is an effect of minimizing pressure. Therefore, the second sealing member S2 can be torn with less force.

[0124] When the second sealing member S2 is torn by the protruding members 111, 112, 113, 114, and 115, the reagent stored in the plurality of second spaces 201, 202, 203, 204, and 205 of the inner chamber 200 flows out through the plurality of first spaces 101, 102, 103, 104, and 105 of the outer chamber 100. Then, the outflowing reagent is discharged through the first discharge holes 121, 122, 123, and 124 formed on the bottom surface of the first spaces 101, 102, 103, 104, and 105. In order to facilitate the discharge of the reagent into the first discharge holes 121, 122, 123, 124, and 125, the area around the first discharge holes 121, 122, 123, 124, and 125 is provided with a portion inclined downward toward the first discharge holes 121, 122, 123, 124, and 125. The inclined portion may have an angle of 3 to 10 degrees, and thus the reagent having flowed into the first spaces 101 , 102 , 103 , 104 , and 105 may be more easily discharged through the first discharge holes 121 , 122 , 123 , 124 , and 125 .

[0125] The cover 300 is configured to be coupled to an upper portion of the outer chamber 100 and to cover the inner chamber 200 and an upper portion of the outer chamber 100 .

[0126] Reference Fig.10 , the cover 300 includes a cover body 301 and a cover body 302 .

[0127] A first insertion hole 307 aligned with the piston insertion portion 108 and a first sample injection hole 309 into which the sample is injected are formed through the cover body 301, and second protrusion members 311, 312, 313, 314 and 315 for tearing the first sealing member S1 and third protrusion members 316 and 317 for tearing the third sealing member S3 protrude from the bottom surface of the cover body 301.

[0128] The second protrusion members 311, 312, 313, 314, and 315 may be provided in one-to-one correspondence with the plurality of first spaces 101, 102, 103, 104, 105, 106, and 107, and the third protrusion members 316 and 317 may be arranged in one-to-one correspondence with the plurality of third spaces 910 and 920. For example, the second protrusion member corresponding to reference numeral 311 tears the first sealing member S1 for sealing the upper portion of the first space corresponding to reference numeral 101, and the second protrusion member corresponding to reference numeral 315 tears the first sealing member S1 for sealing the upper portion of the first space corresponding to reference numeral 105.

[0129] The separation member 320 is formed on the bottom surface of the cover body 301 along the circumference of the first insertion hole 307. The separation member 320 is a portion that allows the first protrusion member and the first sealing member to be separated from each other when the safety clip 500 is coupled to the outer chamber 100. That is, because the separation member 320 is supported by the cover support member 541, the cover 300 is separated from the inner chamber 100 by a predetermined distance.

[0130] The cover body 302 is rotatably connected to one side of the cover body 301 through a hinge. A second insertion hole 308 aligned with the first insertion hole 307 is formed through a central portion of the cover body 302.

[0131] In a state where the cover 300 is coupled to the outer chamber 100, after the safety clip 500 is separated from the outer chamber 100, when the cover 300 is pressed downward, the inner chamber 200 coupled to the outer chamber 100 is lowered along the inner wall of the outer chamber 100. Since the first protrusion members 111, 112, 113, 114, 115, 116, and 117 are formed on the bottom surface of the outer chamber 100, and the second protrusion members 311, 312, 313, 314, and 315 and the third protrusion members 316 and 317 are formed on the bottom surface of the cover 300, the first and second sealing members S1 and S2 that seal the upper and lower openings of the inner chamber 200 and the third sealing member S3 that seals the upper opening of the bead chamber 900 are torn by the protrusion members. Therefore, the reagent contained in the inner chamber 200 flows out into the plurality of first spaces 101, 102, 103, 104 and 105 of the outer chamber 100. Since the second sealing member S2 for sealing the upper opening of the inner chamber 200 is torn, it serves as a vent so that the reagent can be sufficiently discharged into the first spaces.

[0132] The base plate 400 is coupled to the lower portion of the outer chamber 100 , and includes a plurality of paths for guiding reagents to move between the first spaces 101 , 102 , 103 , 104 , 105 , 106 , and 107 of the outer chamber 100 and the fluid receiving chamber of the piston 700 .

[0133] According to an embodiment of the present invention, the substrate 400 may have a liquid flow path through which liquid can move and an air flow path through which air can move. The substrate 400 may also include a flow cover 410 and a gasket 420, the gasket 420 being located between the outer chamber 100 and the substrate 400 and being disposed on the upper surface of the substrate 400 to prevent liquid leakage when the substrate 400 is coupled to the outer chamber 100. When the substrate 400-flow cover 410-gasket 420 are assembled, the liquid flow path and the air flow path of the substrate 400 are sealed on their upper sides by the flow cover 410 and the gasket 420, thereby forming a space and completing a perfect path.

[0134] The liquid flow path is connected to the flow cover 410, the gasket 420, and the outer chamber 100 to provide a space through which samples and reagents can move and mix.

[0135] The air flow path 409 connects the vacuum control part of the amplification module 600 and the piston 700, thereby controlling the vacuum that may occur when the extracted genome moves to the amplification module 600. In addition, contamination of amplification products that may be generated when the genome is amplified can be prevented.

[0136] A plurality of flow paths 401, 402, 403, 404, 405, 406, 407, 408, and 409 are formed on an upper portion of the substrate 400. Each flow path does not cross each other, and is formed to extend from the center to the outer portion of the substrate 400. Here, the liquid flow paths correspond to reference numerals 401 to 408, and the air flow path corresponds to reference numeral 409.

[0137] Reference Fig.14 , one end of some of the multiple paths may be arranged on the same circumference, and the other end thereof may also be arranged on the same circumference.

[0138] A piston driving unit insertion hole 400 a is formed at the center of the base plate 400 so that a driving unit 800 for rotating the piston 700 may be coupled thereto.

[0139] The flow cover 410 is placed in the installation space on the upper portion of the base plate 400. The flow cover 410 may be made of, for example, plastic, and may be ultrasonically welded when being installed on the upper portion of the base plate 400 to be made integral with the base plate 400.

[0140] The flow cover 410 has a first through hole 410a aligned with the piston drive unit insertion hole 400a, and a plurality of first flow cover holes 411a, 412a, 413a, 414a, 415a, 416a, 417a and 418a are formed in the flow cover 410 on a first circumference spaced a first distance from the first through hole 410a, and a plurality of second flow cover holes 411b, 412b, 413b, 414b and 415b are formed in the flow cover 410 on a second circumference spaced a second distance from the first through hole 410a, and a plurality of third flow cover holes 416b, 417b and 418b are formed in the flow cover 410 on a third circumference spaced a third distance from the first through hole 410a. The fourth flow cover holes 419a and 419b are communicated with one end and the other end of the air flow path 409, respectively. Here, the first flow cover hole is aligned with the inner end of the flow path formed in the substrate 400, and the second flow cover hole and the third flow cover hole are aligned with the other end of the flow path. The fourth flow cover hole is connected to one end and the other end of the air flow path. The second distance can be longer than the first distance and shorter than the third distance.

[0141] Reference Fig.11 , a first coupling protrusion 410 b protruding upward and downward on an outer circumference of the first through hole 410 a may be further formed.

[0142] In addition, the melting protrusions 410c connected along the edges of the plurality of flow paths of the substrate 400 may be formed protruding from the bottom surface of the flow cover 410 (see FIG. Fig.12 ). When the flow cover 410 is mounted on the upper surface of the substrate 400 and ultrasonic welding is performed, the melting protrusion 410c is melted and made integral with the substrate 400. Therefore, a close connection between the substrate 400 and the flow cover 410 can be achieved.

[0143] The gasket 420 is placed on the flow cover 410. The gasket 420 may be made of, for example, a silicon material, but any material having a predetermined elasticity may be applied without being particularly limited thereto.

[0144] A plurality of second coupling protrusions 410d protrude from the upper surface of the flow cover 410, and the plurality of second coupling protrusions 410d are coupled to the coupling grooves 420c of the gasket 420, so that a firm coupling can be formed between the flow cover 410 and the gasket 420. In addition, the first coupling protrusions 410b of the flow cover 410 are also inserted into the second through holes 420a of the gasket 420, so that a firm coupling between the two components can be achieved.

[0145] The gasket 420 has a second through hole 420a aligned with the first through hole 410a, and a plurality of first gasket holes 421a, 422a, 423a, 424a, 425a, 426a, 427a, and 428a are formed in the gasket 420 on a first circumference spaced a first distance from the second through hole 420a, and a plurality of second gasket holes 421b, 422b, 423b, 424b, and 425b are formed in the gasket 420 on a second circumference spaced a second distance from the second through hole 420a, and a plurality of third gasket holes 426b, 427b, and 428b are formed in the gasket 420 on a third circumference spaced a third distance from the second through hole 420a. In addition, fourth gasket holes 429a and 429b are formed in the gasket 420 and communicate with one end and the other end of the air flow path 409, respectively. Here, the first gasket hole is aligned with the first flow cover hole, the second gasket hole is aligned with the second flow cover hole, the third gasket hole is aligned with the third flow cover hole, and the fourth gasket hole is aligned with the fourth flow cover hole.

[0146] A protrusion may be further formed at a portion of the upper surface of the liner 420 where the plurality of second liner holes 421b, 422b, 423b, 424b, and 425b, the plurality of third liner holes 426b, 427b, and 428b, and the fourth liner hole 429b are formed. By providing such a protrusion, even if the liner 420 is provided between the outer chamber 100 and the substrate 400 in close contact, the problem that the diameter of the liner hole is reduced differently from the expected reduction can be solved.

[0147] The amplification module 600 is connected to the outer chamber 100 and is configured to receive a sample that has completed pretreatment. Completion of the pretreatment of the sample means that the genome contained in the sample, such as deoxyribonucleic acid (DNA) or ribonucleic acid (RNA), has been dissolved (cracked) into the reagent. When the genome extraction device 1000 according to the present invention is connected to a diagnostic device (not shown), an amplification process (polymerase chain reaction (PCR) etc.) of the genome contained in the amplification module 600 can be performed.

[0148] Reference Figure 1 and Figure 2 , the amplification module 600 is coupled to the outer chamber 100 in a vertical direction. In other words, the amplification module 600 is coupled to the outer chamber 100 such that the upper portion 631 of the accommodating chamber 630 of the amplification module 600 is farther from the ground than the lower portion 632 of the accommodating chamber 630 of the amplification module 600.

[0149] Reference Figures 17 to 29 The amplification module 600 includes a main body 610 , an inlet 621 , an outlet 622 , a containing chamber 630 , a gas moving passage 640 , and an extract moving passage 650 .

[0150] The body 610 is a portion constituting the outer shape of the amplification module 600 , and an inlet 621 and an outlet 622 are formed in a first end 613 of the body 610 coupled to the discharge holes 128 and 129 of the outer chamber 100 .

[0151] The inlet 621 is connected to the discharge hole 129 and serves as an inlet through which the extract discharged from the discharge holes 128 and 129 is injected into the accommodating chamber 630, while the outlet 622 is connected to the discharge hole 129 and serves as an outlet through which the internal air is discharged into the air flow path of the extraction device 1000 when the extract is injected into the amplification module 600.

[0152] That is, in a state where the amplification module 600 is coupled to the extraction device 1000 , the inlet 621 communicates with the liquid flow path 408 , and the outlet 622 communicates with the air flow path 409 .

[0153] The accommodation chamber 630 is a space for accommodating the extract introduced through the inlet 621 , and is formed at a position farther from the extraction device 1000 than the second end 614 of the body 610 , the inlet 621 , and the outlet 622 .

[0154] In one example, the accommodating chamber 630 may be manufactured in a form that penetrates one side and the opposite side of the body 610. However, in another example, the accommodating chamber 630 may be manufactured in a form that penetrates only one side and does not penetrate the opposite side. In both embodiments, the opening portion is sealed by the sealing member S4 and / or S5. Therefore, the extract and air are introduced or discharged only through the gas moving passage 640 and the extract moving passage 650.

[0155] One or more receiving chambers 630 according to an embodiment of the present invention may be provided in one amplification module 600 . Figures 17 to 23 An amplification module including three accommodating chambers is shown. Figure 24 to Figure 29 An amplification module comprising four receiving chambers is shown.

[0156] The accommodation cavity 630 may have a substantially trapezoidal shape, and more specifically, it may preferably have a trapezoidal shape with rounded edges.

[0157] Here, the trapezoidal shape refers to a shape in which the width becomes narrower as the distance from the gas flow path 640 and the extract moving path 650 increases. By making the accommodating chamber 630 have the above-mentioned shape, the problem of bubbles being generated even when the extract is injected through the extract moving path 650 is solved. When bubbles remain in the amplification module 600, especially in the accommodating chamber 630, there is a problem of low analysis accuracy that may occur during the fluorescence detection process after the amplification process. Therefore, this problem can be solved by the shape of the accommodating chamber 630. In the present invention, the amplification process may include an isothermal amplification process (Lamp) and a real-time polymerase chain reaction (Realtime Polymerase Chain Reaction), but the present invention is not particularly limited thereto, as long as it is a process for the genome.

[0158] Primers and probes for amplifying the genome are stored in the accommodating chamber 630. The amplification module 600b according to an embodiment of the present invention includes one or more accommodating chambers 630, and primers and probes for different substances can be set in each accommodating chamber 630. Therefore, multiple different types of virus / disease detection can be performed simultaneously on the genome extracted from one sample. For example, one accommodating chamber 630a can be provided with primers and probes for coronavirus amplification, and another accommodating chamber 630b can be provided with primers and probes for influenza virus amplification, so that different viruses / diseases can be detected simultaneously using one amplification process in one amplification module 600.

[0159] According to one embodiment, the gas moving passage 640 may be formed on one surface 611 of the body 610 and configured to connect the outlet 622 to the upper portion 631 of the housing chamber 630. In contrast, the extract moving passage 650 may be formed on a surface 612 opposite to the one surface 611 and configured to connect the inlet 621 to the lower portion 632 of the housing chamber 630.

[0160] First, refer to Fig. 20 , Fig.23 , Fig.26 and Fig.29 The extract moving path 650 is described. As described above, the extract moving path 650 is used as a path for the movement of the pre-treated extract in the genome extraction apparatus 1000.

[0161] In one embodiment of the present invention, the number of the extract moving passages 650 is the same as the number of the accommodating chambers 630. Fig. 20 In the case of the amplification module 600 including three accommodating chambers 630 shown in FIG. 1 , three extract moving passages 650 are provided. Fig.29In the case of the amplification module 600 shown including four accommodating chambers 630 , four extract movement passages 650 are provided.

[0162] Each extract moving passage 650 is configured so that the volume of the passage is all the same. For example, each extract moving passage 650 may have the same length, width, and depth, and even if at least one of the depth, width, and depth is different, the capacity (volume) of each passage is configured to be the same. Therefore, the extract diffused along the extract moving passage 650 can reach the containing chamber 630 at the same time, so that the extract can be filled into all the containing chambers 630.

[0163] Meanwhile, in order to minimize the generation of bubbles during the distribution of the extract through the extract moving passage 650, the extract moving passage 650 is designed to have a curved passage connecting portion without an angled portion to minimize the generation of bubbles.

[0164] A first branch space 660 is formed between the extract moving passage 650 and the inlet 621. The first branch space 660 allows the inlet 621 and the extract moving passage 650 to communicate with each other.

[0165] Reference Fig. 20 The first branch space 660 includes a first penetration portion 661 and a first recessed portion 662 .

[0166] The first penetration part 661 is configured to penetrate the main body 610 while being connected to the inlet 621, and the first recessed part 662 is formed between the first penetration part 661 and the extract moving passage 650 without penetrating the main body 610, but is configured to be recessed in one surface 611. As described later, a second recessed part 672 is also formed on the opposite surface 612 of the main body 610. Therefore, the first recessed part 662 and the second recessed part 672 are formed at a position where they partially overlap in the width direction. However, the space between the first recessed part 662 and the sealing member and the space between the second recessed part 672 and the sealing member partially overlap, thereby becoming independent spaces that are not connected to each other. If the first recessed part 662 and the second recessed part 672 are configured to penetrate the main body 610, the extract diffused into the extract moving passage 650 through the inlet 621 may also diffuse into the gas moving passage 640, on the contrary, the air discharged from the accommodating chamber 630 to the outlet 622 may also diffuse into the extract moving passage 650. Therefore, in the present invention, the first recessed portion 662 and the second recessed portion 672 are configured in a recessed configuration rather than a penetration configuration. At the same time, even if the first penetration portion and the second penetration portion are formed in a penetration configuration without overlapping each other in the width direction, no interference problem occurs.

[0167] Each extract moving passage 650 starts from the first recessed portion 662 and extends to the accommodating chamber 630 while bending at least once. The width and depth of the first penetration portion 661 and the first recessed portion 662 are respectively greater than the width and depth of the extract moving passage 650. Therefore, assuming that the extract moving passage 650, the first penetration portion 661 and the first recessed portion 662 have the same length, the capacity (volume) of the first penetration portion 661 and the first recessed portion 662 is greater than the capacity (volume) of the extract moving passage 650.

[0168] Therefore, the diffusion speed of the extract in the first branch space 660 through the inlet 621 is slower than the diffusion speed in the extract moving path 650, resulting in a stagnation phenomenon. After the first branch space 660 is completely filled with the extract, the extract may diffuse into the extract moving path 650. Compared with the case where the first branch space 660 is not provided, this configuration has the advantage of allowing the extract to be distributed to each extract moving path 650 at the same time. (In the case of an amplification module without a first branch space, the extract is first injected into the extract moving path located at the lowest position due to gravity).

[0169] Meanwhile, preferably, the first branch space 660 may be formed at the first end 613 in the width direction of the amplification module 600, and the accommodating cavity 630 may be formed at the second end 614 opposite to the first end 613. In other words, preferably, the accommodating cavity 630 and the first branch space 660 may be far apart in the width direction.

[0170] The extract is injected and contained in the containing chamber 630, and the heating device / cooling device is close to or in contact with it to perform an amplification reaction. In order to prevent the amplification product in each containing chamber 630 from being pushed out to the moving passage 640, 650 by the heated temperature during the amplification process or flowing back to another containing chamber 630 in advance, the first branch space 660 and the second branch space 670 described below are located at the first end 613 near the inlet 621 and the outlet 622.

[0171] The gas movement passage 640 serves as a passage through which the gas in the accommodating chamber 630 moves. The flow path of the amplification module 600 is connected to the flow path of the genome extraction device 100, thereby forming a generally closed flow path. Because the accommodating chamber 630 is in a state filled with air before the extract is injected, if the extract is injected, an appropriate amount of air needs to be discharged to the outside. In the present invention, the air inside the amplification module 600 is discharged to the air flow path 409 through the outlet 622 via the gas movement passage 640, thereby preventing the inside of the accommodating chamber 630 from being over-pressurized when the extract is injected, and solving the problem of bubbles generated due to residual air inside. In addition, preferably, the gas movement passage 640 can be provided with a curved passage connection portion, without an angled portion like the accommodating chamber 630, to minimize the generation of bubbles.

[0172] Gas is lighter than liquid such as an extract, and in the present invention, a plurality of gas moving passages 640 are connected to the upper end 631 of the accommodation chamber 630. At the connection point between the accommodation chamber 630 and the gas moving passage 640, a bubble accommodation chamber 633 is provided, which is wider and deeper than other parts of the other gas moving passages. Even if bubbles are generated inside when the extract is injected, the bubbles are accommodated in the wide and deep bubble accommodation chambers 633 and 643, so the bubbles do not affect the accommodation chamber 630.

[0173] Fig.25 A first embodiment of an amplification module having four accommodating chambers 630 is shown. Fig.28 A second embodiment of an amplification module having four receiving chambers 630 is shown.

[0174] Both embodiments are characterized in that the width and depth of the gas moving passage 640 are minimized, thereby minimizing the liquid flowing into the gas moving passage 640 and allowing only air to pass therethrough.

[0175] The gas movement passage 640 of the amplification module 600 according to the first embodiment is composed of a combination of a first gas movement passage 641 having a first width and a first depth, a second gas movement passage 642 having a second width greater than the first width and a first depth, and a third gas movement passage 643 having a third width greater than the second width and a second depth greater than the first depth. Specifically, the amplification module 600 according to the first embodiment is configured so that the volumes of the gas movement passages 640 are the same.

[0176] At the same time, in the gas movement passage 640 of the expansion module 600 according to the first embodiment, the width of the first gas movement passage 641 with the narrowest width and the smallest depth can be 0.135mm to 0.165mm, more specifically 0.14mm to 0.16mm, more specifically 0.145mm to 0.155mm, preferably 0.15mm, and the depth can be 0.045mm to 0.055mm, more specifically 0.0475mm to 0.0525mm, preferably 0.05mm.

[0177] In addition, the gas moving passage 640 of the amplification module 600 according to the second embodiment may have a constant width and depth along its longitudinal direction, the width may be 0.45mm to 0.55mm, more specifically 0.475mm to 0.525mm, more specifically 0.49mm to 0.51mm, preferably 0.5mm, and the depth may be 0.045mm to 0.055mm, more specifically 0.0475mm to 0.0575mm, more specifically 0.049mm to 0.051mm, preferably 0.05mm. In addition, the gas moving passage 640 of the amplification module 600 according to the second embodiment is provided with a plurality of columnar portions r formed in the form of protrusions by a laser pattern processing method. Therefore, the width and depth of the gas moving passage 640 are further minimized, so that the inflow of liquid is minimized and only air can pass through. As in the first embodiment, the amplification module 600 according to the second embodiment is also configured so that the volume of each gas moving passage 640 is the same.

[0178] In the embodiment of the present invention, the number of the gas moving passages 640 is the same as the number of the accommodating chambers 630. In other words, in the case of Fig.19 and 22 In the case of the amplification module 600 including three accommodating chambers 630 shown in FIG. 1 , three gas moving passages 640 are provided, and in the case of Fig.25 and 28 In the case of the amplification module 600 shown including four accommodating chambers 630 , four gas movement passages 640 are provided.

[0179] The piston 700 is inserted into the piston insertion portion 108 of the outer chamber 100 and is configured to suck the reagent contained in the outer chamber 100 or discharge the reagent sucked into the outer chamber 100 or the amplification module 600 according to the lifting and lowering movement.

[0180] Reference Figure 3 and Fig.12 , the piston 700 includes an upper piston 710 and a lower piston 720 .

[0181] The upper piston 710 has an open top, and a fluid containing chamber 701 containing the sucked fluid is formed inside the upper piston 710. A close contact portion 711 is installed inside the upper piston 710. The outer surface of the close contact portion 711 is in close contact with the inner surface of the upper piston 710, so that the fluid cannot enter and leave through the space between the outer surface of the close contact portion 711 and the inner surface of the upper piston 710. A drive unit mounting portion 711a to which a drive unit (not shown) of a diagnostic device is connected is recessed in the center of the close contact portion 711. The drive unit (not shown) of the diagnostic device is connected to the drive unit mounting portion 711a, and by lifting and lowering the close contact portion 711 inside the upper piston 710, the fluid is sucked into the fluid containing chamber 701 or the fluid contained in the fluid containing chamber 701 is discharged to the outside.

[0182] The bottom surface of the upper piston 710 is provided with a coupling structure engaged with the lower piston 720, and a first hole 712 connected to the liquid port of the lower piston 720 and a second hole 713 connected to the filter port of the lower piston 720 are formed in the upper piston 710. The second hole 713 may be formed to have a smaller diameter than the filter placement space of the filter port to prevent the support structure and the filter from being separated.

[0183] The lower piston 720 is fixed by being engaged with a coupling structure formed on a bottom surface of the upper piston 710 .

[0184] The lower piston 720 may include a disc-shaped body 721 , a shaft 722 formed to protrude outward from the center of the body 721 , and a liquid port 723 and a filter port 724 arranged at the same distance from the center of the body 721 .

[0185] The liquid port 723 is used to aspirate, mix, and discharge samples and reagents into the piston 700, and the filter port 724 can be used to clean the genome collection filter or separate the genome from the genome collection filter.

[0186] In addition, a groove recessed toward the center may be formed on the outer circumference of the body 721 of the lower piston 720. The groove is used to remove vacuum that may occur during the movement of liquid inside the genome extraction device.

[0187] The liquid port 723 and the filter port 724 are arranged on the same circumference at a certain angle apart from each other. For example, the two ports of the filter port 724 and the liquid port 723 may be arranged to be spaced 18 to 36 degrees apart from each other, and more specifically, the two ports may be arranged to be spaced 22.5 degrees apart from each other. When a stepper motor divided into 16 steps to perform one rotation is used, the positions of the liquid port 723 and the filter port 724 can be changed by one drive.

[0188] The filter port 724 of the lower piston 720 may include a filter installation space 725, and the filter and the support structure may be arranged in the filter installation space 725. A glass fiber filter having various particle sizes may be used as a filter for collecting genomes, and the support structure is used to fix the filter for collecting genomes.

[0189] The support structure may be formed of a porous plastic material having a constant particle size to prevent the filter from separating and to maintain a constant pressure when discharging fluid.

[0190] The driving unit 800 is connected to a driving unit (not shown) of the diagnostic device, and serves as a medium for rotating the piston 700 at a certain angle.

[0191] The driving unit 800 may include a coupling groove formed at the center of one side of the driving unit 800 to be engaged with the shaft 722 and a driving groove formed at the other side to be engaged with a driving unit (not shown) of a diagnosis device.

[0192] The driving unit 800 is coupled to the piston 700 and allows the liquid port 723 and the filter port 724 to be positioned at appropriate locations of the first exhaust hole of the outer chamber 100 so as to perform various chemical reactions required in the genome extraction operation within one device.

[0193] The liquid port 723 and the filter port 724 are spaced apart from each other at a certain angle, and the drive unit 800 rotates the ports to positions suitable for each operation during genome extraction.

[0194] The bead chamber 900 includes a first bead chamber 910, a second bead chamber 920, and a dehumidification chamber 930 separated by a first bead chamber partition wall 901 and a second bead chamber 902. The first bead chamber 910 is inserted into the first space 106 of the outer chamber 100, and the second bead chamber 920 is inserted into the first space 107 of the outer chamber 100.

[0195] Similar to the inner chamber 200, the upper opening of the microbead chamber 900 is also sealed by the third sealing member S3. When the cover 300 is coupled to the outer chamber 100, the third sealing member S3 is pierced by the third protrusion members 316 and 317 formed on the bottom surface of the cover 300. Since the upper opening of the microbead chamber 900 is opened by the third protrusion members 316 and 317, when the fluid is introduced into the first microbead chamber 910 and the second microbead chamber 920, a corresponding amount of air can be discharged through the pierced portion.

[0196] The lower opening of the microbead chamber 900 is set to an open form and is not sealed with a sealing member alone. Dry microbeads (more specifically freeze-dried microbeads) are stored in the microbead chamber 900, and the dry microbeads have the property of being susceptible to moisture. In the genome extraction device according to the present invention, the lower opening of the microbead chamber 900, the first space of the outer chamber 100, the flow cover 410, the gasket 420, the flow path of the substrate 400 and the flow path of the amplification module 600 are connected to each other, but form a closed flow path that is not exposed to the outside air, so as to minimize the situation where moisture flows into the microbead chamber 900.

[0197] A plurality of dry microbeads b1 required for genome extraction may be stored in the first microbead chamber 910 , and a plurality of dry microbeads b2 required for genome amplification may be stored in the second microbead chamber 920 .

[0198] The first microbead holder 911 is installed in the upper opening of the first microbead chamber 920 to prevent the dry microbeads b11 from being not discharged to the outside but located inside, and the first dehumidification unit 912 is installed in the dehumidification chamber for dehumidifying the inner space of the first microbead chamber 910. Here, the dry microbeads required for genomic material amplification can be provided in the form of capsules, for example, but the present invention is not particularly limited thereto.

[0199] A second bead holder 921 is installed in the upper opening of the second bead chamber 920 to prevent the dry beads b2 from being discharged to the outside but located inside, and a second dehumidifying portion 922 for dehumidifying the inside of the second bead chamber 920 is installed above the second bead holder 921.

[0200] The third sealing member S3 seals the second microbead chamber 920 so that the second microbead chamber 920, the dehumidification chamber 930, and the first microbead chamber 910 are not communicated with each other, but the first microbead chamber 910 and the dehumidification chamber 930 are communicated with each other. Fig.30 and Fig.31 Describe in detail.

[0201] The above effect is achieved by configuring the height difference between the first microbead chamber partition wall 901 and the second microbead chamber partition wall 902. Fig.30 and Fig.31 The second microbead chamber partition wall 902 partitioning the second microbead chamber 920 and the dehumidification chamber 930 has a higher height than the first microbead chamber wall 901 partitioning the first microbead chamber 910 and the dehumidification chamber 930 .

[0202] In other words, the upper portion of second bead chamber partition wall 902 extends to the same height as the upper portion of the outer wall defining second bead chamber 920, and the upper portion of first bead chamber partition wall 901 extends to a lower height than the upper portion of the outer wall defining first bead chamber 910.

[0203] Therefore, even if the upper opening of the microbead chamber 900 is sealed by the third sealing member S3, the first microbead chamber 910 and the dehumidification chamber 930 can communicate with each other through the space between the first microbead chamber partition wall 901 and the third sealing member S3. Therefore, the first microbead chamber 910 is dehumidified by the second dehumidification unit 922 installed inside the dehumidification chamber 930.

[0204] A lower opening 914 of the first microbead chamber 910 (i.e., the outlet of the first microbead chamber) and a lower opening 924 of the second microbead chamber 920 (i.e., the outlet of the second microbead chamber) are formed at lower ends of the exhaust passages 913 and 923, which become narrower from the microbead chamber 900 toward the substrate 400.

[0205] Dry microbeads may be accommodated in the discharge passages 913 and 923, and a microbead holder may be installed on upper portions of the discharge passages 913 and 923 to prevent the microbeads accommodated in the discharge passages 913 and 923 from being discharged to the outside.

[0206] The exhaust passages 913 and 923 may have a so-called tapered shape that becomes narrower toward the substrate 400. The diameter of the lower openings 914 and 924 located at the ends of the exhaust passages 913 and 923 is set to be smaller than the diameter of the dry microbeads so that the microbeads are not discharged to the outside through the lower openings 914 and 924. The fluid flows into the exhaust passages 913 and 923 through the lower openings 914 and 924, the introduced fluid dissolves the dry microbeads, and the dry microbeads can be discharged to the outside (the fluid containing chamber of the piston or the amplification module) through the lower openings 914 and 924 only in the form of fluid.

[0207] Here, the discharge passage 913 of the first microbead chamber 910 in which the dry microbeads required for genome amplification are stored has a larger diameter than the discharge passage 923 of the second microbead chamber 920 , and may become smaller toward the substrate 400 .

[0208] The configuration of introducing the final fluid before injecting the pretreated extract into the amplification module 600 corresponds to the first microbead chamber 910. Because accurate detection results can only be obtained when the fluid injected into the first microbead chamber 910 is not retained in the first microbead chamber 910 as much as possible and needs to be injected into the accommodating chamber 630 of the amplification module 600, in the present invention, the discharge passage 913 of the first microbead chamber 910 has a wider diameter than the discharge passage 923 of the second microbead chamber 920 and the discharge passage gradually narrows, so that the residual amount of the fluid in the first microbead chamber 910 is minimized.

[0209] In addition, the microbead chamber 900 according to the present invention has first locking protrusions 903 and 904 extending from the bottom surface of the outer partition wall of the first microbead chamber 910 and the second microbead chamber 920. Fig.32 and Fig.34 As shown, the first locking protrusions 903 and 904 may be formed in a structure extending toward the substrate 400 and protruding outward.

[0210] In the outer chamber 100 coupled to the microbead chamber 900, the second locking protrusion 109a is formed on one side of the outer chamber partition wall that separates the plurality of first spaces, and when a force is applied to the microbead chamber 900 toward the substrate 400, the first locking protrusions 903 and 904 pass through the second locking protrusion 109a and are coupled to each other, so that a secure coupling between the two components can be achieved. When the first locking protrusions 903 and 904 are coupled to the second locking protrusion 109a, the relative position of the microbead chamber 900 relative to the outer chamber 100 is fixed.

[0211] Hereinafter, an extraction method according to an embodiment of the present invention will be described in detail.

[0212] First, (a) the inner chamber is coupled to the outer chamber through the upper openings of the plurality of first spaces of the outer chamber. Here, preferably, the fixing portion of the inner chamber can be coupled to the outer chamber while being coupled to the inner chamber coupling portion of the safety clip.

[0213] Next, (b) the cover is coupled to the outer chamber, and (c) the safety clip is removed from the outer chamber.

[0214] Next, (d) the cover is pressed, and the first sealing member sealing the upper opening of the inner chamber is torn by the first protrusion member formed on the bottom surface of the cover, and the second sealing member sealing the lower opening of the inner chamber is torn by the second protrusion member formed on the bottom surface of the plurality of first spaces of the outer chamber, so that the reagent contained in the inner chamber flows out into the plurality of first spaces, and (e) by being driven by the driving unit, the reagents flowing out into the plurality of first spaces are sucked into the fluid containing chamber inside the upper piston and mixed with each other, and then the mixed reagents are discharged into the amplification module.

[0215] The above step (e) may include a plurality of sub-steps. Hereinafter, step (e) will be described in more detail below.

[0216] First, (e1) a sample to be analyzed is introduced into one of the plurality of first spaces of the outer chamber through the sample introduction hole of the cover.

[0217] Next, (e2) the piston installed in the piston accommodating chamber of the outer chamber rotates so that the liquid port of the piston and the first discharge hole formed through the bottom surface of any one of the first spaces into which the sample to be analyzed is placed communicate with each other.

[0218] Next, (e3) the close contact portion installed in the inner space of the piston is lifted so that the sample to be analyzed contained in any one of the first spaces is sucked into the fluid containing chamber inside the outer chamber.

[0219] Next, (e4) the piston is rotated so that the liquid port of the piston and the first discharge hole formed in the bottom surface of the other first space are communicated with each other.

[0220] Next, (e5) the close contact portion is lifted so that the first reagent contained in the other first space is sucked into the fluid receiving chamber inside the outer chamber, so that the sample to be analyzed and the first reagent are mixed in the fluid receiving chamber.

[0221] Next, (e6) the piston is rotated so that the liquid port of the piston and the first discharge hole formed in the bottom surface of the other first space are communicated with each other.

[0222] Next, (e7) the close contact portion is lifted so that the second reagent contained in the other first space is sucked into the fluid containing chamber inside the outer chamber, whereby the sample to be analyzed, the first reagent, and the second reagent are mixed with each other.

[0223] Next, (e8) the piston is rotated so that the filter port of the piston and the first discharge hole formed in the bottom surface of the other first space are communicated with each other.

[0224] Next, (e9) the close contact portion is lowered so that the mixed solution contained in the fluid containing chamber passes through the genome collecting filter installed in the filter port and is discharged into another first space.

[0225] Next, (e10) the piston is rotated so that the liquid port of the piston and the first discharge hole formed in the bottom surface of the first space accommodating the first reagent, the second reagent, and other reagents are communicated with each other.

[0226] Next, (e11) the close contact portion is lifted so that other reagents are sucked into the fluid receiving chamber and mixed with each other.

[0227] Next, (e12) the piston is rotated so that the filter port of the piston and the first discharge hole formed in the bottom surface of the first space accommodating other reagents are communicated with each other.

[0228] Next, (e13) the close contact portion is lowered so that the mixed solution contained in the fluid containing chamber passes through the genome collecting filter and is discharged into the first space containing other reagents.

[0229] Next, (e14) the piston is rotated so that the liquid port of the piston and the first discharge hole formed in the bottom surface of the first space accommodating the eluent are communicated with each other.

[0230] Next, (e15) the close contact portion is lifted so that the eluent is sucked into the fluid receiving chamber.

[0231] Next, (e16) the piston is rotated so that the filter port of the piston and the second discharge hole formed in the bottom surface of the first space accommodating the microbeads required for genome amplification are communicated with each other.

[0232] Next, (e17) the close contact portion is lowered so that the eluate contained in the fluid holding chamber passes through the genome collection filter and is discharged into the first space containing the microbeads required for genome amplification, and the genome collected by the genome collection filter is separated from the genome collection filter and discharged into the first space together.

[0233] Next, (e18) the piston is rotated so that the liquid port of the piston and the second discharge hole formed in the bottom surface of the first space accommodating the genome are communicated with each other.

[0234] Next, (e19) the close contact portion is lifted so that the extract containing the genome is sucked into the fluid containing chamber.

[0235] Next, (e20) the piston is rotated so that the liquid port of the piston and the amplification module are connected to each other.

[0236] Next, (e21) the close contact portion is lowered so that the genome-containing extract contained in the fluid holding chamber is discharged to the amplification module.

[0237] Next, (e22) the extract is introduced into the containing chamber of the amplification module through the extract moving path of the amplification module.

[0238] Next, (e23) the air remaining in the containing chamber is discharged to the outside of the amplification module through the gas moving passage of the amplification module.

[0239] Next, (e24) the amplification device applies heat of a predetermined temperature or higher to the containing chamber to amplify the genome.

[0240] Next, (e25) based on the fluorescence intensity of the amplified product of the genome, it is determined whether the sample to be analyzed is infected with the disease.

[0241] As mentioned above, although this specification has been described with reference to the embodiments shown in the accompanying drawings so that those skilled in the art can easily understand and reproduce the present invention, this is only exemplary, and those skilled in the art will understand that various modifications and other equivalent embodiments can be obtained from the embodiments of the present invention. Therefore, the protection scope of the present invention should be determined by the claims.

[0242] Reference numerals list

[0243] S1: First sealing member

[0244] S2: Second sealing member

[0245] S3: Third sealing member

[0246] S4, S5: Sealing components

[0247] 100: Outer chamber

[0248] 100a: Upper part of outer surface

[0249] 100b: Lower part of outer surface

[0250] 101, 102, 103, 104, 105, 106, 107: First Space

[0251] 108: Piston insertion part

[0252] 109: Installation section

[0253] 190a: Second locking protrusion

[0254] 111, 112, 113, 114, 115: first protruding member

[0255] 111a, 112a, 113a, 114a, 115a: protrusions

[0256] 111b, 112b, 113b, 114b, 115b: Wings

[0257] 119: Second locking protrusion

[0258] 121, 122, 123, 124, 125: First discharge hole

[0259] 126, 127, 129: Second discharge hole

[0260] 128: Air discharge hole

[0261] 130: Insert space

[0262] 131: Stopper

[0263] 200: Inner chamber

[0264] 201, 202, 203, 204, 205: Second Space

[0265] 210: Upper inner chamber

[0266] 220: Lower inner chamber

[0267] 230: Fixed part

[0268] 300: Cover

[0269] 301: Cover body

[0270] 302: Cover

[0271] 307: First insertion hole

[0272] 308: Second insertion hole

[0273] 311, 312, 313, 314, 315: second protruding member

[0274] 316, 317: Third protruding member

[0275] 320: Separation of components

[0276] 400: Substrate

[0277] 400a: Piston drive unit insertion hole

[0278] 401, 402, 403, 404, 405, 406, 407, 408: Liquid flow path

[0279] 409: Air flow path

[0280] 410: Flow cover

[0281] 410a: first through hole

[0282] 410b: first coupling protrusion

[0283] 410c: Melted protrusion

[0284] 410d: second coupling protrusion

[0285] 411a, 412a, 413a, 414a, 415a, 416a, 417a, 418a: first flow cover hole

[0286] 411b, 412b, 413b, 414b, 415b: second flow cover hole

[0287] 416b, 417b, 418b: third flow cover hole

[0288] 419a, 419b: fourth flow cover hole

[0289] 420: Padding

[0290] 420a: Second through hole

[0291] 421a, 422a, 423a, 424a, 425a, 426a, 427a, 428a: first pad hole

[0292] 421b, 422b, 423b, 424b, 425b: Second gasket hole

[0293] 426b, 427b, 428b: Third gasket hole

[0294] 429a, 429b: Fourth gasket hole

[0295] 420c: coupling groove

[0296] 500: Safety clip

[0297] 510: External chamber connection part

[0298] 520: handle

[0299] 530: Upper extension

[0300] 540: Side extension

[0301] 541: Cover support member

[0302] 542: Inner chamber connection part

[0303] 600: Amplification module

[0304] 610: Main body

[0305] 611: A Surface

[0306] 612: Relative surface

[0307] 613: First End

[0308] 614: Second End

[0309] 621: Entrance

[0310] 622: Exit

[0311] 630: Accommodation cavity

[0312] 631: Upper part

[0313] 632: Lower part

[0314] 633: Bubble containment chamber

[0315] 640: Gas movement pathway

[0316] 641: First gas flow path

[0317] 642: Second gas flow path

[0318] 643: Third gas flow path

[0319] 650: Extract migration pathway

[0320] 660: The First Branch Space

[0321] 661: First penetration

[0322] 662: First recessed portion

[0323] 670: Second Branch Space

[0324] 671: Second penetration

[0325] 672: Second recessed portion

[0326] 700: Piston

[0327] 701: Fluid receiving chamber

[0328] 710: Upper piston

[0329] 711: Close contact part

[0330] 711a: Drive unit installation part

[0331] 712: First hole

[0332] 713: Second hole

[0333] 720: Lower piston

[0334] 721: Main body

[0335] 722: Axis

[0336] 723: Liquid port

[0337] 724: Filter port

[0338] 800: Drive unit

[0339] 900: Bead chamber

[0340] 910: First microbead chamber

[0341] 911: The first microbead holder

[0342] 912: Dehumidification part

[0343] 913: Emission channel

[0344] 914: Lower opening

[0345] 920: Second microbead chamber

[0346] 921: Second microbead holder

[0347] 922: Second dehumidification section

[0348] 924: Lower opening

[0349] 930: Dehumidification room

[0350] 1000: Genome extraction device.

Claims

1. An amplification module, comprising: main body; an inlet formed in the body and introducing an extract through the opening; a plurality of receiving chambers connected to the inlet and receiving the introduced extract; a first branch space communicating with the inlet; a plurality of extract moving passages, the plurality of extract moving passages branching from the first branch space and connecting the inlet and the plurality of accommodating chambers to each other; an outlet formed in the body and through which gas is discharged; as well as A plurality of gas movement passages connect the outlet and the plurality of accommodation chambers to each other.

2. The amplification module according to claim 1, wherein: The first branch space includes: a first penetration portion that penetrates the body and is connected to the inlet; and A first recessed portion is formed between the first penetration portion and the plurality of extract movement paths and is recessed in one surface of the body.

3. The amplification module according to claim 2, wherein: At least one of a width and a depth of the first branch space is wider or deeper than a width and a depth of the extract movement path.

4. The amplification module according to claim 1, wherein: The volumes of the plurality of extract movement passages are all the same.

5. The amplification module according to claim 1, wherein: The first branch space is formed at a first end of the amplification module in the width direction, and the plurality of accommodation cavities are formed at a second end of the amplification module opposite to the first end in the width direction.

6. The amplification module according to claim 2, further comprising a second branch space formed between the outlet and the plurality of gas moving passages, in, The second branch space includes: a second penetration portion that penetrates the body and is connected to the outlet; and A second recessed portion is formed between the second penetration portion and the plurality of gas movement passages and is recessed in the other surface of the body.

7. The amplification module according to claim 6, wherein: The first recessed portion and the second recessed portion have a portion in which the first recessed portion and the second recessed portion partially overlap in the width direction of the main body and are recessed in the main body.

8. The amplification module according to claim 7 further includes a sealing member, which is attached to a surface of the main body and a surface opposite to the one surface, and is configured to seal and separate the multiple accommodating cavities, the first branch space, the second branch space, the extract movement passage and the gas movement passage from the external space.

9. The amplification module according to claim 8, wherein: A space between the first recessed portion and the sealing member and a space between the second recessed portion and the sealing member are not communicated with each other.

10. The amplification module according to claim 1, wherein: The gas movement passage is connected to an upper portion of the housing chamber, and the gas movement passage forms a space wider and deeper than other portions at a connection point between the gas movement passage and the housing chamber.

11. The amplification module according to claim 1, wherein: At least one of a width and a depth of the gas movement passage is narrower or shallower than a width and a depth of the extract movement passage.

12. The amplification module according to claim 11, wherein: The gas movement passage is formed by a combination of one or more of the following: a first gas movement passage having a first width and a first depth; a second gas movement passage having the first depth and a second width greater than the first width; as well as A third gas movement passage has a third width greater than the second width and a second depth greater than the first depth.

13. The amplification module according to claim 11, wherein: A plurality of columnar portions protrude from the gas movement passage.

14. The amplification module according to claim 12 or 13, wherein: The gas movement passages connected to the plurality of accommodation chambers all have the same capacity.

15. The amplification module according to claim 1, wherein: A probe and a primer for amplifying a first target substance are stored in one of the plurality of accommodating chambers, and a probe and a primer for amplifying a second target substance different from the first target substance are stored in another accommodating chamber.

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