Genome extraction device with a double-chamber structure in which an outer chamber and a bead chamber are interlocked

The dual-chamber genome extraction device addresses reagent leakage and cross-contamination issues through a separate inner chamber, safety clip, and sloped discharge, ensuring efficient and sealed reagent transfer and bead preservation.

JP7771232B2Active Publication Date: 2025-11-17SD BIOSENSOR INC
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Patent Information

Application Number
JP2023580718
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2021-06-29
Filing Date
2021-09-07
Publication Date
2025-11-17
Estimated Expiration
2041-09-07

AI Technical Summary

Technical Problem

Conventional genome extraction devices suffer from reagent leakage, cross-contamination, and inefficient processing due to separate equipment requirements and structural vulnerabilities during handling and storage.

Method used

A dual-chamber structure with a separate inner chamber for reagents and a bead chamber, featuring a safety clip to prevent puncturing, a unique inner chamber design to prevent capillary action, and a sloped discharge hole for smooth reagent flow, along with a double-structured flow cover-pad to maintain a sealed path and dehumidifying units to preserve bead performance.

Benefits of technology

The device effectively prevents reagent leakage, reduces cross-contamination, ensures smooth reagent discharge, and maintains bead performance by sealing and dehumidifying mechanisms, facilitating efficient genome extraction and amplification.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention relates to a genome extraction device having a dual chamber structure of an outer chamber and a bead chamber, and provides a genome extraction device in which the performance of dry beads, which are sensitive to moisture, can be maintained for a long period of time by applying the above-mentioned dual chamber structure.
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Description

[Technical Field]

[0001] The present invention relates to a genome extraction device having a dual chamber structure in which an outer chamber and a bead chamber are engaged. [Background technology]

[0002] In modern times, advances in biotechnology have made it possible to understand the causes of diseases at the genetic level, which has led to an ever-increasing demand for the manipulation and biochemical analysis of biological samples to cure or prevent human diseases.

[0003] In addition to disease diagnosis, there is a demand for technology to extract and analyze nucleic acids from biological samples and samples containing cells in a variety of fields, including new drug development, preliminary testing for viral and bacterial infections, and forensic medicine.

[0004] Conventional genome extraction equipment requires separate equipment for each processing step (concentration, purification), and after one processing step is completed, the sample must be moved to another device, which takes a long time.

[0005] In order to solve the conventional problem of low detection efficiency during such a long processing process, the present applicant has developed and used patents such as Patent No. 10-1989920.

[0006] In the above document, the buffer is directly dispensed into the buffer chamber and stored, but there is a problem that micro-leakage occurs through the various layer structures at the bottom of the buffer chamber during long-term storage, adversely affecting extraction performance.

[0007] In addition, the pad placed between the upper body and the base plate is made of rubber, but as the pad is pressed between the upper body and the base plate, the diameter of the hole formed through the pad decreases, causing a problem in which a volume of extract different from the intended volume of the product design moves to the amplification module.

[0008] Furthermore, due to vibrations occurring during the production and distribution of the product, the sealing member sealing the buffer chamber may be punctured by the protruding member, resulting in leakage and contamination of the reagent stored inside the buffer chamber.

[0009] Therefore, the present inventors focused on and completed the present invention in order to solve the problems of conventional genome extraction devices. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] Korean Patent Registration No. 10-1989920 [Patent Document 2] Korean Patent Registration No. 10-2065649 [Patent Document 3] Korean Patent Registration No. 10-2065650 [Patent Document 4] Korean Patent Registration No. 10-2076220 Summary of the Invention [Problem to be solved by the invention]

[0011] According to the present invention, an inner chamber containing reagents necessary for genome extraction is provided separately from an outer chamber, and the upper and lower parts of the inner chamber are sealed, thereby solving the problem of reagents contained in a single chamber leaking out in conventional genome extraction devices.

[0012] Another object of the present invention is to provide a genome extraction device including a safety clip to prevent the protruding members formed on the cover and outer chamber from puncturing the sealing members that seal the upper and lower openings of the inner chamber due to the inner chamber moving up and down due to vibrations that occur during the production and distribution process of the product.

[0013] Another objective of the present invention is to provide a genome extraction device that 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).

[0014] Another objective is to provide a genome extraction device that has a unique inner chamber design (upper inner chamber) to prevent reagents from leaking out in a structure that prevents capillary action.

[0015] Another object of the present invention is to provide a genome extraction device in which the sealing member can be broken with little force due to the configuration of the first protruding member formed on the bottom surface of the outer chamber, and the perforated portion expands, allowing the reagent contained inside the inner chamber to smoothly flow out to the outside.

[0016] Another object of the present invention is to provide a genome extraction device in which a sloped portion is formed around a discharge hole through which a reagent is discharged, thereby enabling the reagent to be smoothly discharged through the discharge hole.

[0017] In addition, the purpose of this invention is to provide a genome extraction device that is easier to manufacture and solves the problem of unintentional narrowing of the flow path, by arranging a double-structured flow cover-pad between the outer chamber and the base plate, compared to conventional genome extraction devices that have only one pad arranged.

[0018] Another object of the present invention is to provide a genome extraction device in which a tightly sealed flow path is formed without intermediate leakage during the reagent transfer process by achieving a strong engagement between the base plate, flow cover, pad, and outer chamber.

[0019] Another objective of the present invention is to provide a genome extraction device that can maintain the performance of beads, which are sensitive to moisture, for a long period of time by having a double chamber structure consisting of an outer chamber and a bead chamber in the bead chamber that contains the beads necessary for genome extraction and amplification.

[0020] Another object of the present invention is to provide a genome extraction device in which the performance of the beads is maintained by a dehumidifying unit located above the bead chamber even when the bead chamber is opened.

[0021] Another object of the present invention is to provide a genome extraction device using an amplification module that allows a sufficient volume of extract to be introduced by easily expelling any air remaining inside the storage section as the pretreated extract is introduced.

[0022] In addition, the amplification module has multiple storage compartments, each of which stores different primers and probes for genome amplification, and the purpose is to provide a genome extraction device that can diagnose several types of diseases through a single genome extraction.

[0023] Another object of the present invention is to provide a genome extraction device in which the length, thickness, and pattern of the gas transfer passage and the extract transfer passage are different depending on the position of the connected storage section, thereby preventing the extraction or amplification product introduced into the storage section from mixing.

[0024] Another object of the present invention is to provide a genome extraction method using the genome extraction device described above. [Means for solving the problem]

[0025] One embodiment of the present invention to solve the above problems provides an extraction device including: an outer chamber whose interior is divided into a plurality of first spaces by outer chamber partitions; a bead chamber that engages with the outer chamber through upper openings of the plurality of first spaces and whose interior is divided into a plurality of third spaces by bead chamber partitions, the third space containing beads necessary for genome extraction and amplification; and a base plate that engages with the lower part of the outer chamber and has a plurality of flow channels formed on its upper surface that communicate with the plurality of first spaces, the upper openings of the plurality of third spaces being covered by a third sealing member, and the lower openings communicating with the plurality of first spaces and the plurality of flow channels forming closed flow channels.

[0026] In one embodiment, the outer chamber may further include a cover for covering the upper openings of the plurality of first spaces, the cover having a third protruding member formed on a bottom surface thereof to break the third sealing member.

[0027] In one embodiment, the plurality of third spaces include a first bead chamber containing beads necessary for genome amplification, a second bead chamber containing beads necessary for genome extraction, and a dehumidifying chamber disposed between the first bead chamber and the second bead chamber, and bead holders may be installed inside the first bead chamber and the second bead chamber to prevent the beads from escaping outside the third space.

[0028] In one embodiment, the plurality of third spaces are provided with dehumidifying units for dehumidifying the interiors of the plurality of third spaces, and a first dehumidifying unit for dehumidifying the interiors of the first bead chamber may be provided within the dehumidifying chamber, and a second dehumidifying unit for dehumidifying the interiors of the second bead chamber may be provided within the second bead chamber.

[0029] In one embodiment, a first bead chamber partition wall separating the first bead chamber and the dehumidification chamber may be provided at a height lower than a second bead chamber partition wall separating the second bead chamber and the dehumidification chamber.

[0030] In one embodiment, the upper portion of the second bead chamber partition extends to the same height as the upper portion of the outer partition that forms the second bead chamber, and the upper portion of the first bead chamber partition extends to a height lower than the upper portion of the outer partition that forms the first bead chamber. When the upper opening of the bead chamber is sealed by the third sealing member, the first bead chamber and the dehumidification chamber can communicate with each other through the space between the first bead chamber partition and the third sealing member.

[0031] In one embodiment, the lower openings of the first bead chamber and the second bead chamber may be formed at the ends of discharge passages that narrow toward the base plate.

[0032] In one embodiment, the discharge passage of the first bead chamber may have a wider diameter than the discharge passage of the second bead chamber and may narrow toward the base plate.

[0033] In an embodiment, a second discharge hole communicating with a flow path formed in the base plate may be formed in a bottom surface of the first space communicating with the plurality of third spaces.

[0034] In one embodiment, the pump may further include a piston having an open top, a fluid receiving portion formed therein for receiving the fluid discharged through the second discharge hole, an upper piston having a hole formed in a lower portion thereof aligned with the second discharge hole, a sealing portion installed so as to be able to rise and fall within the fluid receiving portion, and a lower piston engaged with the upper piston, having a liquid port and a filter port formed in a lower portion thereof.

[0035] In one embodiment, the valve may further include a driving unit that passes through the base plate and engages with the lower piston, and the driving unit may rotate the lower piston so that the liquid port or the filter port communicates with any one of the plurality of first spaces.

[0036] In one embodiment, when the contact portion descends within the fluid accommodating portion, the fluid within the fluid accommodating portion is discharged to the first bead chamber or the second bead chamber through the liquid port or the filter port, and when the contact portion ascends within the fluid accommodating portion, the fluid accommodated in the first bead chamber or the second bead chamber can be sucked into the fluid accommodating portion.

[0037] In one embodiment, the apparatus may further include an amplification module including an inlet that engages with the extraction device, a storage portion that is a space for storing the fluid discharged through the inlet, a gas transfer passage formed on one side connecting the inlet to the storage portion, and an extract transfer passage formed on the opposite side of the one side connecting the inlet to the storage portion.

[0038] In one embodiment, a first locking protrusion is formed extending from the bottom surface of the outer partition wall that defines the plurality of third spaces, and a second locking protrusion is formed on one side of the outer chamber partition wall that defines the plurality of first spaces of the outer chamber, and the relative position of the bead chamber to the outer chamber can be fixed by engaging the first locking protrusion with the second locking protrusion.

[0039] In one embodiment, the diameter of the lower open end of the first bead chamber and the diameter of the lower open end of the second bead chamber may be smaller than the diameter of the bead. [Effects of the Invention]

[0040] The genome extraction device according to the present invention has an inner chamber containing reagents necessary for genome extraction, which is separate from the outer chamber, and the top and bottom of the inner chamber are sealed, thereby solving the problem of reagents contained in a single chamber leaking out in conventional genome extraction devices.

[0041] In addition, when the inner chamber moves up and down due to vibrations that occur during the production and distribution process of the product, the protruding members formed on the cover and the outer chamber prevent the sealing members that seal the upper and lower openings of the inner chamber from being punctured.

[0042] Furthermore, the problem of cross-contamination between reagents is resolved by capillary action occurring through the space between the double chambers.

[0043] Furthermore, the structure for preventing capillary action prevents the reagent from leaking out.

[0044] In addition, the protruding member formed on the bottom surface of the outer chamber allows the sealing member to be broken with little force, expanding the perforated area and allowing the reagent contained inside the inner chamber to smoothly flow out.

[0045] In addition, a sloped portion is formed around the outlet hole through which the reagent is discharged, so that the reagent can be smoothly discharged through the outlet hole.

[0046] In addition, the dual-structure flow cover-pad is placed between the outer chamber and the base plate, which improves ease of manufacturing compared to conventional genome extraction devices that only have one pad, and solves the problem of unintentional narrowing of the flow path.

[0047] Furthermore, by achieving a strong engagement between the base plate, flow cover, pad and outer chamber, a sealed flow path is formed without intermediate leakage during the reagent transfer process.

[0048] In addition, the bead chamber containing the beads necessary for genome extraction and amplification also has a double chamber structure consisting of an outer chamber and a bead chamber, which makes it possible to maintain the performance of the beads, which are sensitive to moisture, for a long period of time.

[0049] In addition, even if the bead chamber is opened, the performance of the bead is maintained by the dehumidifying unit located above the bead chamber.

[0050] Furthermore, by adding the pretreated extract, any air remaining inside the container can be easily expelled, and a sufficient volume of extract can be added to the amplification module.

[0051] In addition, the amplification module has a plurality of storage compartments, each of which stores different primers and probes for genome amplification, making it possible to diagnose several types of diseases through a single genome extraction.

[0052] In addition, the length, thickness, and pattern of the gas transfer passage and the extract transfer passage are different depending on the position of the connected storage section, thereby preventing the extract or amplification product introduced into the storage section from being mixed. [Brief explanation of the drawings]

[0053] [Figure 1] 1 is a perspective view showing the overall appearance of a genome extraction device according to an embodiment of the present invention. [Figure 2] FIG. 2 is a perspective view of the genome extraction device of FIG. 1 as seen from another side. [Figure 3] FIG. 2 is an exploded perspective view of FIG. 1. [Figure 4] 10 is a diagram illustrating an engagement relationship between an outer chamber and an inner chamber. [Figure 5] 10 is a diagram illustrating an engagement relationship between an inner chamber and a safety clip. [Figure 6] FIG. 1 is a plan view of the outer chamber. [Figure 7]FIG. 10 is a cross-sectional view illustrating the engagement relationship between the inner chamber and the outer chamber. [Figure 8] 10 is an enlarged view illustrating a protruding member formed on the bottom surface of an outer chamber. [Figure 9] 1 is a diagram for explaining the inner chamber in more detail. [Figure 10] FIG. 10 is a bottom perspective view for more specifically illustrating the cover. [Figure 11] FIG. 10 is an exploded perspective view for more specifically illustrating the flow cover and pad disposed between the base plate and the outer chamber. [Figure 12] FIG. 2 is an exploded perspective view for specifically explaining the configuration of the piston. [Figure 13] FIG. [Figure 14] FIG. 4 is a perspective view for more specifically explaining the base plate. [Figure 15] 1 is a cross-sectional view for specifically explaining a genome extraction device according to an embodiment of the present invention. [Figure 16] FIG. 2 is another cross-sectional view for specifically explaining the genome extraction device according to an embodiment of the present invention. [Figure 17-19] 1 is a diagram illustrating an amplification module according to a first embodiment of the present invention. [Figure 20-22] 10 is a diagram illustrating an amplification module according to a second embodiment of the present invention. [Figure 23-25] 10 is a diagram illustrating an amplification module according to a third embodiment of the present invention. [Figure 26] FIG. 2 is a plan view of the bead chamber. [Figure 27-28] FIG. 2 is a perspective view for more specifically explaining the configuration of a bead chamber. [Figure 29] FIG. 29 is a cross-sectional view of the bead chamber of FIG. 28. [Figure 30] 29 is a longitudinal cross-sectional view of the bead chamber of FIG. 28, illustrating the structure engaged with the outer chamber. DETAILED DESCRIPTION OF THE INVENTION

[0054] In some cases, well-known structures and devices may be omitted or shown in block diagram form, focusing on the core functions of each structure and device, in order to avoid obscuring the concepts of the present invention.

[0055] Throughout the specification, when a part "comprising" or "including" a certain element(s), this does not mean excluding other elements, but means further including other elements, unless otherwise specified to the contrary. Furthermore, terms such as "unit," "group," and "module" used in the specification refer to a unit that processes at least one function or operation, and this may be implemented in hardware, software, or a combination of hardware and software. Furthermore, in the context of describing the present invention (particularly in the context of the following claims), the terms "a" (or "an"), "one," "the," and similar related words are used to include both the singular and the plural, unless otherwise indicated in the specification or clearly contradicted by the context.

[0056] In describing embodiments of the present invention, if a detailed description of known functions or configurations is deemed to unnecessarily obscure the gist of the present invention, such detailed description will be omitted. Furthermore, the terms used below are defined in consideration of the functions in the embodiments of the present invention, and may vary depending on the intentions or practices of users or operators. Therefore, the definitions should be based on the overall content of this specification.

[0057] The present invention will now be described in detail with reference to the accompanying drawings.

[0058] Referring to Figures 1 and 2, a 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 base plate (400), a safety clip (500), an amplification module (600), a piston (700), a drive unit (800), and a bead chamber (900).

[0059] The outer chamber (100) is divided into a plurality of first spaces (101, 102, 103, 104, 105, 106, 107) by outer chamber partitions. That is, the plurality of first spaces (101, 102, 103, 104, 105, 106, 107) may be spaces independent from each other.

[0060] The first spaces (101, 102, 103, 104, 105, 106, 107) may have an open top and a closed bottom. First discharge holes (121, 122, 123, 124, 125) are formed through the bottoms of the first spaces (101, 102, 103, 104, 105) and are spaced a first distance from the center of the outer chamber (100) along the circumferential direction. Second discharge holes (126, 127) are formed through the bottoms of the remaining first spaces (106, 107) and are spaced a second distance from the center of the outer chamber (100) along the circumferential direction. Discharge holes (128, 129) are formed through the bottoms of the spaces between the first spaces (106, 107) and communicate with the amplification module (600). Here, the first distance may be shorter than the second distance, but in other embodiments, the first distance may be longer than the second distance.

[0061] The first spaces (101, 102, 103, 104, 105) are filled with reagents stored in an inner chamber (200) described below, and the remaining first spaces (106, 107) are filled with beads stored in a bead chamber (900).

[0062] Piston inserting portions 108 into which pistons 700 are inserted are formed vertically through the centers of the plurality of first spaces 101, 102, 103, 104, 105, 106, and 107. The pistons 700 are inserted into the piston inserting portions 108, and a driving portion (not shown) of the diagnostic device engages with the pistons 700 to move the pistons 700 up and down, thereby allowing reagents (fluids) in the first spaces 101, 102, 103, 104, 105, 106, and 107 to enter and exit the fluid receiving portions 701 inside the pistons 700. More details will be described later.

[0063] 4, the upper outer surface (100a) of the outer chamber (100) is connected to the upper portion of the lower outer surface (100b) and recessed toward the center. The safety clip (500) engages with the upper outer surface (100a) of the outer chamber (100), and the boundary between the upper outer surface (100a) and the lower outer surface (100b) serves as the short jaw of the safety clip (500), allowing the safety clip (500) to maintain its engagement position after engaging with the upper outer surface (100a). The safety clip (500) includes an outer chamber engaging portion (510) that extends long enough to at least partially surround the periphery of the upper outer surface (100a) of the outer chamber (100) and a handle (520) formed on one side of the outer chamber engaging portion (510).

[0064] By engaging the safety clip (500) with the outer chamber (100), the cover (300) applies pressure to the inner chamber (200) engaged with the outer chamber (100), preventing the upper and lower openings of the inner chamber (200) from opening. The user can begin the extraction process by grasping the handle (520) and removing the safety clip (500) from the outer chamber (100). In other words, when the safety clip (500) is engaged with the outer chamber (100), the reagent in the inner chamber (200) cannot be introduced into the outer chamber (100); only when the safety clip (500) is removed from the outer chamber (100) can the reagent in the inner chamber (200) be introduced into the outer chamber (100).

[0065] The construction of the safety clip (500) will be described in more detail with reference to FIGS.

[0066] The safety clip (500) includes an outer chamber engaging portion (510), a handle (520), a top extension (530), and a side extension (540).

[0067] The outer chamber engaging portion 510 engages with the outer chamber 100 while surrounding at least a portion of the outer surface (specifically, the upper outer surface 100a) of the outer chamber 100. More specifically, the outer chamber engaging portion 510 engages with the outer chamber 100 so as to surround the four outer surfaces of the outer chamber 100, but the extended ends of the outer chamber engaging portion 510 may be configured to be spaced apart from each other. As shown in FIG. 1, when the safety clip 500 engages with the outer chamber 100, the extended end of the outer chamber engaging portion 510 rests on one of the outer surfaces of the outer chamber 100, and the safety clip 500 can only be separated from the outer chamber 100 by the user grasping the safety clip 500 and applying an external force in one direction.

[0068] The handle (520) is a portion that extends outward from the outer chamber engagement portion (510) and is the portion that is grasped by the user to separate the safety clip (500) from the outer chamber (100).

[0069] The upper extension (530) extends upward from one side of the outer chamber engaging portion (510), and the side extension (540) extends from the upper extension (530) toward the center of the outer chamber (100).

[0070] The safety clip (500) according to an embodiment of the present invention is characterized in that a cover support member (541) is protruding from the upper surface of the side extension portion (540), and an inner chamber engagement portion (542) is protruding from the extension end of the side extension portion (540).

[0071] The cover support member (541) serves to prevent the protruding members (311, 312, 313, 314, 315, 316, 317) formed on the bottom surface of the cover (300) from tearing (puncturing) the first sealing member (S1) sealing the upper openings of the multiple second spaces (201, 202, 203, 204, 205) of the inner chamber (200) and the third sealing member (S3) sealing the upper opening of the bead chamber (900) when the safety clip (500) engages with the outer chamber (100).

[0072] 15, when the safety clip 500 is engaged with the outer chamber 100 and the inner chamber 200, the contact between the protruding members 311, 312, 313, 314, 315, 316, 317 and the first and third sealing members S1 and S3 is blocked. Therefore, when the safety clip 500 is engaged with the outer chamber 100 and the inner chamber 200, perforation of the inner chamber 200 and the bead chamber 900 is prevented, thereby preventing the reagent contained in the inner chamber 200 and the beads contained in the bead chamber 900 from leaking into the outer chamber 100.

[0073] The inner chamber engaging portion 542 is a portion that engages with the fixing portion 230 of the inner chamber 200 when the safety clip 500 engages with the outer chamber 100. When the inner chamber engaging portion 542 engages with the fixing portion 230, the bottom surface of the inner chamber 200 is positioned at a predetermined distance from the bottom surface of the outer chamber 100, and therefore, the second sealing member S2 that seals the lower openings of the plurality of second spaces 201, 202, 203, 204, 205 is prevented from tearing by the protruding members 111, 112, 113, 114, 115 formed on the bottom surface of the outer chamber 100 (see FIG. 15).

[0074] In the attached drawings, the inner chamber engaging portion (542) is shown in the form of an engaging protrusion and the fixing portion (230) is shown in the form of an engaging groove that engages with the engaging protrusion, but in other embodiments, the inner chamber engaging portion (542) may be provided in the form of an engaging groove and the fixing portion (230) may be provided in the form of an engaging protrusion that engages with the engaging groove.

[0075] The outer chamber (100) (more specifically, the outer chamber partition) has a recessed seating portion (109) that provides a space for the fixing portion (230) of the inner chamber (200) to be seated. 500 ) and is fixed at a position spaced a predetermined distance from the bottom of the outer chamber (100), and the fixing part (230) of the inner chamber (200) is seated and supported by the seating part (109), which can further improve the fixing force.

[0076] 7, an insertion space (130) is recessed into the upper inner wall of the outer chamber (100), and the engagement hook (240) of the inner chamber (200) can engage with the insertion space (130). A stopper (131) is formed on the upper side of the insertion space (130) so as to protrude toward the inside of the outer chamber (100). Therefore, when the inner chamber (200) is not pressurized by the cover (300), the engagement hook (240) of the inner chamber (200) is positioned on the stopper (131), but when the inner chamber (200) is pressurized by the cover (300), the engagement hook (240) can pass through the stopper (131) and be inserted into the insertion space (130).

[0077] Referring to Figure 15, the engagement relationship between the outer chamber and the inner chamber according to another embodiment of the present invention will be described. In Figure 7, instead of the engagement hooks (240) formed on the inner chamber (200), a locking protrusion (250) is provided protruding outward from the outer wall of the inner chamber (200), and the locking protrusion (250) engages with a stopper (131) formed on the inner wall of the outer chamber (100), 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 pressurized by the cover (300), the locking protrusion (250) passes through the stopper (131) and is inserted into the insertion space (130), thereby piercing the second sealing member (S2) that seals the multiple second spaces in the inner chamber (200) by the protruding member formed on the outer chamber (100).

[0078] The inner chamber (200) is divided into a plurality of second spaces (201, 202, 203, 204, 205) by inner chamber partitions. That is, the plurality of second spaces (201, 202, 203, 204, 205) may be spaces independent from each other.

[0079] The upper and lower portions of the second spaces (201, 202, 203, 204, 205) are open (i.e., the second spaces have upper and lower openings), and the upper portions are sealed by a first sealing member (S1), and the lower portions are sealed by a second sealing member (S2). The first sealing member (S1) and the second sealing member (S2) may be, for example, a film, but are not limited thereto, and a film made of any material that is impermeable to fluids may be used.

[0080] Different reagents are poured into the plurality of second spaces (201, 202, 203, 204, 205), and the reagents are poured into the plurality of second spaces after the second sealing member (S2) seals the lower portions of the plurality of second spaces, and the first sealing member (S1) seals the upper portions of the plurality of second spaces, thereby completing the pouring of the reagent into the inner chamber (200).

[0081] Referring to FIG. 4, the inner chamber (200) includes an upper inner chamber (210) and a lower inner chamber (220).

[0082] The upper inner chamber (210) is integrally formed and is configured to fit tightly against the inner wall of the outer chamber (100) when engaged with the outer chamber (100).

[0083] The lower inner chamber (220) is connected to the upper inner chamber (210) and includes a portion that is bent (toward the radially inward direction) so as to be separated from the inner wall of the outer chamber (100) when engaged with the outer chamber (100).

[0084] In the present invention, since a dual chamber structure consisting of an inner chamber and an outer chamber is used, there is a risk of cross-contamination between reagents in the inner chamber (200) during operation. Cross-contamination occurs when capillary action occurs through the minute space between the inner and outer chambers. In order to prevent this cross-contamination problem, the present invention employs a curved structure in which the inner chamber (200) is sufficiently spaced from the inner wall of the outer chamber (100), thereby preventing capillary action.

[0085] In addition, the outer chamber (100) and the inner chamber (200) are designed to be separated to prevent capillary action, and the upper inner chamber (210) is configured to adhere closely to the inner wall of the outer chamber (100) to prevent the reagent from leaking out through the separated area.

[0086] Meanwhile, second protruding members (111, 112, 113, 114, 115) are protrudingly formed on the bottom surfaces of the first spaces (101, 102, 103, 104, 105) to break the second sealing member (S2) of the inner chamber (200) so that the reagent contained in the inner chamber (200) flows out into the first spaces (101, 102, 103, 104, 105).

[0087] Each second protruding member (111, 112, 113, 114, 115) may be arranged in one-to-one correspondence with a plurality of first spaces (101, 102, 103, 104, 105). For example, the second protruding member corresponding to reference numeral 111 breaks the second sealing member (S2) sealing the lower part of the second space corresponding to reference numeral 201, and the second protruding member corresponding to reference numeral 115 breaks the second sealing member (S2) sealing the lower part of the second space corresponding to reference numeral 205.

[0088] The second protruding members (111, 112, 113, 114, 115) include protruding portions (111a, 112a, 113a, 114a, 115a) that protrude from the bottom surfaces of the multiple first spaces (101, 102, 103, 104, 105) by a first height (h1), and blade portions (111b, 112b, 113b, 114b, 115b) that extend from the protruding portions (111a, 112a, 113a, 114a, 115a) and protrude from the bottom surfaces by a second height (h2) that is lower than the first height (h1). Here, the blade portions (111b, 112b, 113b, 114b, 115b) may have a structure extending in both the left and right directions from the protrusions (111a, 112a, 113a, 114a, 115a).

[0089] The protrusion serves to pierce the second sealing member (S2), and the wing serves to expand the perforation of the second sealing member (S2). In the present invention, since the height of the protrusion is higher than the wing, point contact is made between the second sealing member (S2) that seals the lower part of the inner chamber (200) and the protrusion, which has the effect of minimizing pressure when the second sealing member (S2) is torn through the point contact. Therefore, the second sealing member (S2) can be torn with less force.

[0090] When the second sealing member (S2) is torn by the protruding members (111, 112, 113, 114, 115), the reagent stored in the second spaces (201, 202, 203, 204, 205) of the inner chamber (200) flows out into the first spaces (101, 102, 103, 104, 105) of the outer chamber (100). The leaked reagent is then discharged through the first discharge holes (121, 122, 123, 124, 125) formed on the bottom surfaces of the first spaces (101, 102, 103, 104, 105). In order to facilitate the outflow of the reagent to the first outlet holes (121, 122, 123, 124, 125), there are portions around the first outlet holes (121, 122, 123, 124, 125) that are inclined downward toward the first outlet holes (121, 122, 123, 124, 125). The inclined portions may have an angle of 3 to 10 degrees, which facilitates the process of the reagent that has flowed into the first spaces (101, 102, 103, 104, 105) flowing out to the first outlet holes (121, 122, 123, 124, 125).

[0091] The cover (300) is configured to engage with the top of the outer chamber (100) and cover the outer chamber (100) and the top of the inner chamber (200).

[0092] Referring to FIG. 10, the cover (300) includes a cover body (301) and a lid (302).

[0093] The cover body (301) is formed with a first insertion hole (307) aligned with the piston insertion portion (108) and a first specimen insertion hole (309) through which the specimen is inserted (in the attached drawing, the first specimen insertion hole (309) is aligned with the first space (105), and the specimen can be inserted into the first space (105) through the first specimen insertion hole (309)), and the bottom surface of the cover body (301) is formed with first protruding members (311, 312, 313, 314, 315) for breaking the first sealing member (S1) and third protruding members (316, 317) for breaking the third sealing member (S3).

[0094] The first protruding members (311, 312, 313, 314, 315) may be arranged in one-to-one correspondence with the plurality of first spaces (101, 102, 103, 104, 105, 106, 107), and the third protruding members (316, 317) may be arranged in one-to-one correspondence with the plurality of third spaces (910, 920). For example, the first protruding member corresponding to reference numeral 311 breaks the first sealing member (S1) sealing the upper part of the second space corresponding to reference numeral 201, and the first protruding member corresponding to reference numeral 315 breaks the first sealing member (S1) sealing the upper part of the second space corresponding to reference numeral 205.

[0095] A spacing member 320 is formed on the bottom surface of the cover body 301 along the periphery of the first insertion hole 307. The spacing member 320 separates the first protruding member and the first sealing member from each other when the safety clip 500 is engaged with the outer chamber 100. That is, the spacing member 320 is supported by the cover support member 541, so that the cover 300 is spaced a predetermined distance from the inner chamber 100.

[0096] The cover 302 is hingedly connected to one side of the cover body 301. A second insertion hole 308 aligned with the first insertion hole 307 is formed through the center of the cover 302.

[0097] With the cover (300) engaged with 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) engaged with the outer chamber (100) descends along the inner wall of the outer chamber (100). Second protruding members (111, 112, 113, 114, 115, 116, 117) are formed on the bottom surface of the outer chamber (100), and first protruding members (311, 312, 313, 314, 315) and third protruding members (316, 317) are formed on the bottom surface of the cover (300). The protruding members cause the first sealing member (S1) and second sealing member (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) to tear. Therefore, the reagent contained in the inner chamber (200) flows out into the multiple first spaces (101, 102, 103, 104, 105) of the outer chamber (100), and the second sealing member (S2) sealing the upper opening of the inner chamber (200) tears, thereby acting as an air vent to ensure that the reagent is sufficiently discharged into the first spaces.

[0098] The base plate (400) is engaged with the lower part of the outer chamber (100) and includes a plurality of channels that guide the path along which the reagent moves between the first spaces (101, 102, 103, 104, 105, 106, 107) of the outer chamber (100) and the fluid-containing portion of the piston (700).

[0099] According to one embodiment of the present invention, the base plate 400 may have liquid flow paths 401-408 through which liquid can move and an air flow path 409 through which air can move, and a flow cover 410 and a pad 420 may be further provided on the upper surface of the base plate 400 between the outer chamber 100 and the base plate 400 to prevent leakage of liquid when the outer chamber 100 is engaged. When the base plate 400, flow cover 410, and pad 420 are engaged, the upper surfaces of the liquid flow paths and air flow paths of the base plate 400 are blocked by the flow cover 410 and the pad 420, forming a space and completing the flow paths.

[0100] The liquid flow paths (401 to 408) are connected to the flow cover (410), the pad (420) and the outer chamber (100) to provide a space in which the sample and the reagent can move and mix.

[0101] The air flow path (409) connects the amplification module (600) and the vacuum control portion of the piston (700), and serves to control the vacuum that may be generated when the genome extracted from the amplification module (600) moves, thereby preventing contamination of the amplification products that may be generated during genome amplification.

[0102] In one embodiment, one end of the air flow path (409) is connected to the fluid storage portion (701) of the piston (700) and the other end is connected to the amplification module (600), so that air discharged from the amplification module (600) can pass through the air flow path (409) and be discharged to the fluid storage portion (701).

[0103] A plurality of flow channels (401, 402, 403, 404, 405, 406, 407, 408, 409) are formed on the upper portion of the base plate (400). Base plate ( The liquid flow passages are formed so as to extend from the center of the nozzle 400 to the outer periphery thereof. Here, the liquid flow passages are components corresponding to reference numerals 401 to 408, and the air flow passage is a component corresponding to reference numeral 409.

[0104] 14, some of the multiple flow paths have one end located on the same circumference, and the other ends thereof may also be located on the same circumference. Among the multiple flow paths, one end of the air flow path (409) is located on a different circumference from one end of the other liquid flow paths (401-408), and the other end is also located on a different circumference from the other ends of the other liquid flow paths (401-408), making it possible to control a vacuum.

[0105] A piston driving part insertion hole (400a) is formed through the center of the base plate (400) so that the piston driving part (800) for rotating the piston (700) can be engaged therewith.

[0106] A flow cover 410 is placed in the seating space on the upper part of the base plate 400. The flow cover 410 may be made of, for example, plastic, and may be ultrasonically fused to the upper part of the base plate 400 while seated thereon, thereby being integral with the base plate 400.

[0107] The flow cover (410) has a first through hole (410a) aligned with the insertion hole (400a) of the piston drive unit, and a plurality of first flow cover holes (411a, 412a, 413a, 414a, 415a, 416a, 417a, 418a) formed on a first circumference at a first distance from the first through hole (410a), and a plurality of first flow cover holes (411a, 412a, 413a, 414a, 415a, 416a, 417a, 418a) formed on a second circumference at a second distance from the first through hole (410a). A plurality of second flow cover holes (411b, 412b, 413b, 414b, 415b) are formed through the first through hole (410a), a plurality of third flow cover holes (416b, 417b, 418b) are formed through the first through hole (410a) on a third circumference at a third distance from the first through hole (410a), and fourth flow cover holes (419a, 419b) are formed through the first through hole (410a) and communicate with one end and the other end of the air flow path (409). Base plate ( The second flow cover hole is aligned with one inner end of the flow path formed in the nozzle 400, the second flow cover hole and the third flow cover hole are aligned with the other outer ends of the flow path, and the fourth flow cover hole communicates with one end and the other end of the air flow path. The second distance may be longer than the first distance and shorter than the third distance.

[0108] Referring to FIG. 11, a first engaging protrusion 410b protruding upward and downward may be further formed on the outer periphery of the first through-hole 410a.

[0109] In addition, melt protrusions 410c may be formed on the bottom surface of the flow cover 410 to engage with the edges of the flow channels of the base plate 400 (see FIG. 12). When ultrasonic welding is performed after the flow cover 410 is placed on the top surface of the base plate 400, the melt protrusions 410c melt and become integrated with the base plate 400. This allows for close contact between the base plate 400 and the flow cover 410.

[0110] A pad 420 is placed on the flow cover 410. The pad 420 may be made of, for example, a silicon material, but may be made of any material having a predetermined elasticity without being limited thereto.

[0111] The flow cover 410 has a plurality of second engagement protrusions 410d formed on its upper surface, and the second engagement protrusions 410d engage with the engagement grooves 420c of the pad 420, thereby achieving a strong engagement between the flow cover 410 and the pad 420. In addition, the first engagement protrusions 410b of the flow cover 410 are inserted and coupled into the second through holes 420a of the pad 420, thereby achieving a strong engagement between the two components.

[0112] The pad (420) has a second through hole (420a) aligned with the first through hole (410a), a plurality of first pad holes (421a, 422a, 423a, 424a, 425a, 426a, 427a, 428a) formed therethrough on a first circumference at a first distance from the second through hole (420a), a plurality of second pad holes (421b, 422b, 423b, 424b, 425b) formed therethrough on a second circumference at a second distance from the second through hole (420a), a plurality of third pad holes (426b, 427b, 428b) formed therethrough on a third circumference at a third distance from the second through hole (420a), and fourth pad holes (429a, 429b) communicating with one end and the other end of the air flow path (409) formed therethrough. Here, the first pad hole is aligned with the first flow cover hole, the second pad hole is aligned with the second flow cover hole, the third pad hole is aligned with the third flow cover hole, and the fourth pad hole is aligned with the fourth flow cover hole.

[0113] The pad 420 has a protrusion on its upper surface that narrows upward from the area where the plurality of second pad holes 421b, 422b, 423b, 424b, and 425b, the plurality of third pad holes 426b, 427b, and 428b, and the fourth pad hole 429b, which is connected to the other end of the air flow path, are formed. The protrusion prevents the pad hole diameter from decreasing unintentionally even when the pad 420 is closely placed between the outer chamber 100 and the base plate 400.

[0114] The amplification module (600) is connected to the outer chamber (100) and is configured to receive a pre-treated sample. Pre-treatment of the sample means that genomes such as DNA and RNA contained in the sample have been lysed into a reagent. When the genome extraction device (1000) according to the present invention is connected to a diagnostic device (not shown), an amplification process (e.g., PCR) of the genome received in the amplification module (600) is performed.

[0115] 1 and 2, the amplification module (600) engages with the outer chamber (100) vertically, i.e., the upper portion (631) of the housing portion (630) of the amplification module (600) engages with the outer chamber (100) so that the upper portion (631) is higher than the lower portion (632) of the housing portion (630) on the outer chamber (100).

[0116] 17 to 25, the amplification module (600) includes a body (610), inlets (621, 622), a container (630), a gas transfer passage (640), and an extract transfer passage (650).

[0117] The body (610) is a part that forms the outer shape of the amplification module (600), and one side of the body (610) is formed with inlet ports (621, 622) that engage with the outlet ports (128, 129) of the outer chamber (100).

[0118] The inlets (621, 622) are engaged with the discharge holes (128, 129) and serve as inlets for introducing the extract discharged from the discharge holes (128, 129) into the storage section (630).

[0119] The amplification module 600 according to the embodiment of the present invention may have two inlets 621, 622, but is not limited thereto, and embodiments having more than two inlets may also be included within the scope of the present invention.

[0120] In the following, it is assumed that the amplification module 600 according to the embodiment of the present invention has two injection ports 621 and 622.

[0121] One of the two inlets (621, 622), inlet (621), is connected to the air flow path (409), and the other inlet (622) is connected to the liquid flow path (408). That is, an extract containing a pretreated sample flows in through the other inlet (622), and during this process, air in the receptacle (630) can be discharged into the air flow path (409) through one of the inlets (621).

[0122] The other side of the body (610) is formed with a receiving portion (630) which is a space for receiving the extract flowed in through the inlet (621).

[0123] In one example, the receiving portion (630) can be manufactured in a form that completely penetrates one side of the body (610) and the opposite side, or in another example, it can be manufactured in a form that penetrates only one side and does not penetrate the opposite side. Both of these embodiments have the same feature that the open portion is sealed with a sealing member. Therefore, the extract and air are introduced into or discharged from the receiving portion (630) only through the gas transfer passage (640) and the extract transfer passage (650).

[0124] According to an embodiment of the present invention, one or more receiving units 630 may be provided in one amplification module 600. Figure 17 shows an amplification module having one receiving unit, Figure 20 shows an amplification module having two receiving units, and Figure 23 shows an amplification module having four receiving units.

[0125] The receiving portion (630) may have a generally trapezoidal shape, and more specifically, it is preferable that the receiving portion (630) has a trapezoidal shape with rounded edges.

[0126] Here, the trapezoidal shape means that the width narrows as it moves away from the gas transfer passage 640 and the extract transfer passage 650. The shape of the receiving portion 630 solves the problem of air bubbles being generated when the extract is injected through the extract transfer passage 650. If air bubbles remain in the receiving portion 630, it can cause detection failure during the fluorescence detection process after the amplification process, and the shape of the receiving portion 630 can solve this problem.

[0127] Primers and probes necessary for genome amplification are stored in the storage unit (630). The amplification module (600) according to an embodiment of the present invention includes one or more storage units (630), and each storage unit (630) may be equipped with different types of primers and probes. This provides the advantage of being able to simultaneously perform multiple detection processes on genomes extracted from a single specimen. For example, one storage unit (630a) may be equipped with primers and probes for coronavirus amplification, and another storage unit (630b) may be equipped with primers and probes for influenza virus amplification, allowing multiple detection processes to be performed simultaneously in a single amplification module (600).

[0128] The gas transfer passage (640) is formed on one side (611) of the body (610) and is configured to connect the inlet (621) to the upper part (631) of the container (630). Conversely, the extract transfer passage (650) is formed on the opposite side (612) of the body (610) and is configured to connect the inlet (622) to the lower part (632) of the container (630).

[0129] The gas transfer passage (640) serves as a passage through which the gas in the container (630) moves. 1000 ) and at the same time has the characteristics of a closed flow path. Because the container (630) is filled with air before the extract is poured, an appropriate volume of air must be discharged to the outside when the extract is poured. In the present invention, the air inside the container (630) is discharged to the air flow path (409) via the gas transfer passage (640) through the inlet (621), thereby solving the problem of air bubbles generated by residual air remaining in the container (630) as the pressure inside the container (630) decreases. Like the container (630), the gas transfer passage (640) has curved connection points without sharp edges, minimizing the generation of air bubbles.

[0130] Since gas is lighter than liquid such as the extract, the gas transfer passage (640) is connected to the end of the upper portion (631) of the container (630).

[0131] When a plurality of receiving portions 630 are provided, it is preferable that the lengths of the gas transfer passages 640 connected to the respective receiving portions 630 are different from each other.

[0132] In an embodiment having a plurality of receiving portions 630, the extract is injected from the lower receiving portion, and the upper receiving portion receives the extract at a later time. Therefore, the time it takes for air to be discharged from the corresponding receiving portion 630 varies depending on the position of the receiving portion 630. In other words, the lower the receiving portion, the faster the air is discharged through the gas transfer passage 640.

[0133] In addition, not only the air inside the receptacle 630 but also the extract introduced into the receptacle 630 can be discharged through the gas transfer passage 640. Because the multiple gas transfer passages 640 are connected to each other, the extract discharged through one gas transfer passage 640 may enter another receptacle along another gas transfer passage 640, which may cause a problem of the extract or the amplified product being mixed. To solve this problem, in the present invention, the gas transfer passages 640 connected to the receptacle 630 located at the bottom are formed longer, thereby solving the problem of the extract or the amplified product being mixed.

[0134] The gas transfer passages 640 can be configured to have different lengths as shown in FIG. 21 or as shown in FIG.

[0135] Referring to FIG. 24, the gas transfer passage (640) is formed on one surface (611) of the body (610) and is connected to the gas discharge passage (633) connected to the upper portion (631) of the receiving portion (630). The gas transfer passage (640) includes a communication hole (641) penetrating the body (610), a transfer passage (642), a storage passage (643), and a passage pattern forming portion (644).

[0136] The passage pattern forming portion 644 is configured to form a predetermined passage pattern in the moving passage 642. Taking FIG. 24 as an example, the passage pattern forming portion 644 may have a semicircular shape, and the semicircular passage pattern forming portion 644 may be combined with the linear moving passage 642 to form the passage pattern shown in FIG. 24. The passage pattern forming portion 644 may be combined with the moving passage 642 alternately on the left and right sides of the linear moving passage 642 to form the passage pattern shown in FIG. 24. Here, "combined" means that the empty space in the moving passage 642 is filled with the shape of the passage pattern forming portion 644, and the filled space does not allow fluid to pass through.

[0137] That is, the portion of the gas transfer passage 640 that is combined with the passage pattern forming portion 644 corresponds to the transfer passage 642, and the portion of the gas transfer passage 640 that is not combined corresponds to the storage passage 643.

[0138] The length of the gas transfer passage (640) increases proportionally as the number of passage pattern forming parts (644) and the number of storage passages (643) increase, and the lower the receiving part is, the more passage pattern forming parts (644) and storage passages (643) it has, which prevents the extraction solution or amplification product contained in the receiving part (630) from mixing.

[0139] The extract transfer passage (650) is formed on one side (611) of the body (610) and the opposite side (612) thereof, and is configured to connect the inlet (622) with the lower part (632) of the receiving part (630). The extract transfer passage (650) serves as a passage through which the extract pretreated in the genome extraction device (1000) moves.

[0140] The extract transfer passage (650) also prevents the extraction liquid or amplification product contained in the storage section (630) from mixing, or allows the same amount of extraction liquid to be introduced into each storage section (630).If multiple storage sections (630) are provided, the length of each extract transfer passage (650) may be the same, or if the lengths are different, the thickness of each extract transfer passage (650) may be different.

[0141] In addition, in order to prevent the generation of bubbles during the process of the extract moving through the extract moving passage (650), the extract moving passage (650) has curved connecting portions without sharp edges, thereby minimizing the generation of bubbles.

[0142] 25, the extract passage (650) extends from the inlet (622) and branches off at one point, with the lower receiving sections being thicker and the upper receiving sections being thinner from the point of branching. The thinner the passage, the faster the extract passes through, so the same amount of extract can be introduced into both the upper and lower receiving sections.

[0143] The piston (700) is inserted into the piston insertion portion (108) of the outer chamber (100) and is configured to move up and down to suck in reagents contained in the outer chamber (100) or expel reagents sucked into the outer chamber (100) or the amplification module (600).

[0144] Referring to Figures 3 and 12, the piston (700) includes an upper piston (710) and a lower piston (720).

[0145] The upper piston 710 has an open top and a fluid receiving portion 701 formed therein for receiving the drawn fluid. A sealing portion 711 is installed inside the upper piston 710. The outer surface of the sealing portion 711 is in close contact with the inner surface of the upper piston 710, preventing fluid from entering or exiting through the space between the outer surface of the sealing portion 711 and the inner surface of the upper piston 710. A drive unit mounting portion 711a is recessed in the center of the sealing portion 711 to engage with a drive unit (not shown) of a diagnostic device. The drive unit (not shown) of the diagnostic device engages with the drive unit mounting portion 711a and raises and lowers the sealing portion 711 inside the upper piston 710, thereby drawing fluid into the fluid receiving portion 701 or discharging the fluid contained in the fluid receiving portion 701 to the outside.

[0146] An engagement structure for engaging with the lower piston 720 may be formed on the bottom surface of the upper piston 710, 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 through the bottom surface of the upper piston 710. The second hole 713 is formed to have a smaller diameter than the filter seating space of the filter port to prevent the support structure and the filter from coming off.

[0147] The lower piston (720) is fixed by engaging with a coupling structure formed on the bottom surface of the upper piston (710).

[0148] The lower piston (720) may include a disk-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).

[0149] The liquid port (723) is used to draw, mix, and discharge the sample and reagent into the piston (700), and the filter port (724) is used to wash the genome collection filter and separate the genome from the genome collection filter.

[0150] In addition, a groove recessed toward the center may be formed on the outer periphery of the body 721 of the lower piston 720. This groove serves to remove vacuum that may occur when liquid moves inside the extractor.

[0151] The liquid port 723 and the filter port 724 are arranged on the same circumference at a fixed angle. For example, the filter port 724 and the liquid port 723 can be arranged at an angle of 18 to 36 degrees from each other, and more specifically, the two ports can be arranged at an interval of 22.5 degrees. When using a step motor that rotates once in 16 steps, the positions of the liquid port 723 and the filter port 724 can be changed with a single drive.

[0152] The filter port 724 of the lower piston 720 may include a filter seating space 725, and a filter and a support structure may be placed in the filter seating space 725. The filter for genome capture is a glass fiber filter having various particle sizes, and the support structure serves to fix the filter for genome capture.

[0153] The support structure may be made of a porous plastic material having a certain granularity to prevent the filter from coming off when fluid is discharged and to maintain a certain pressure.

[0154] The driving part (800) is connected to a driving part (not shown) of the diagnostic equipment and serves as a mediator for rotating the piston (700) at a certain angle.

[0155] The driving part (800) may include an engagement groove formed in the center of one side to engage with the shaft (722), and a driving groove formed on the other side to engage with the driving part (not shown) of the diagnostic equipment.

[0156] The drive unit (800) engages with the piston (700) to position the liquid port (723) and filter port (724) at the appropriate position of the first discharge hole of the outer chamber (100) so that the various chemical reactions required for the genome extraction step can be performed within a single device.

[0157] The liquid port (723) and the filter port (724) are spaced apart at a certain angle, and the drive unit (800) rotates the ports to positions appropriate for each stage during genome extraction.

[0158] The bead chamber (900) includes a first bead chamber (910), a second bead chamber (920) and a dehumidifying chamber (930), which are separated by a first bead chamber partition (901) and a second bead chamber partition (930). - Bulkhead ( 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).

[0159] Similar to the inner chamber 200, the upper opening of the bead chamber 900 is also sealed by a third sealing member S3, which is pierced by third protruding members 316, 317 formed on the bottom surface of the cover 300 when the cover 300 is engaged with the outer chamber 100. The third protruding members 316, 317 open the upper opening of the bead chamber 900, so that even if a fluid is subsequently introduced into the first bead chamber 910 and the second bead chamber 920, a corresponding amount of air can be discharged through the pierced portion.

[0160] The bottom opening of the bead chamber (900) is open and not sealed with a separate sealing member. The bead chamber (900) stores dry beads (more specifically, freeze-dried beads), which are susceptible to moisture. In the genome extraction device according to the present invention, the bottom opening of the bead chamber (900), the first space of the outer chamber (100), the flow cover (410), the pad (420), the channels of the base plate (400), and the channels of the amplification module (600) are connected to one another, but are closed channels that are not exposed to the outside air, thereby minimizing the inflow of moisture into the bead chamber (900).

[0161] The first bead chamber (910) can store several dry beads (b1) required for genome extraction, and the second bead chamber (920) can store several dry beads (b2) required for genome amplification.

[0162] A first bead holder (911) configured to keep dry beads (b1) inside without being discharged to the outside is installed at the top opening of the first bead chamber (910), and a first dehumidifying unit (912) for dehumidifying the internal space of the first bead chamber (910) is installed in the dehumidifying chamber (930). Here, the dry beads required for genome amplification are provided in the form of, for example, capsules, but are not limited thereto.

[0163] A second bead holder (921) configured to keep the dry beads (b2) inside without being discharged to the outside is installed at the upper opening of the second bead chamber (920), and a second dehumidifying unit (922) for dehumidifying the inside of the second bead chamber (920) is installed above the second bead holder (921). A third sealing member (S3) seals the second bead chamber (920) so that it does not communicate with the dehumidifying chamber (930) and the first bead chamber (910), but seals the first bead chamber (910) so that they communicate with each other. This will be described in detail with reference to Figures 26 and 27.

[0164] This effect is achieved by configuring the height difference between the first bead chamber partition wall 901 and the second bead chamber partition wall 902. Referring to Figures 26 and 27, the second bead chamber partition wall 902, which separates the second bead chamber 920 and the dehumidifying chamber 930, has a higher height than the first bead chamber partition wall 901, which separates the first bead chamber 910 and the dehumidifying chamber 930.

[0165] In other words, the top of the second bead chamber partition (902) extends to the same height as the top of the outer partition that forms the second bead chamber (920), and the top of the first bead chamber partition (901) extends to a lower height than the top of the outer partition that forms the first bead chamber (910).

[0166] Therefore, even if the upper opening of the bead chamber (900) is sealed by the third sealing member (S3), the first bead chamber (910) and the dehumidifying chamber (930) can communicate with each other through the space between the first bead chamber partition wall (901) and the third sealing member (S3). Therefore, the first bead chamber (910) is dehumidified by the second dehumidifying unit (912) installed inside the dehumidifying chamber (930).

[0167] The lower opening ( 914 ) (i.e., the outlet of the first bead chamber) and the lower opening ( 924 ) (i.e., the outlet of the second bead chamber) is a discharge passage ( 913,923 ) is formed at the end of

[0168] Discharge passage ( 913,923 ) can accommodate dry beads inside, and the discharge passage ( 913,923 ) is installed at the top of the bead holder, and the discharge passage ( 913,923 ) can prevent the beads contained in the container from leaking out.

[0169] Discharge passage ( 913,923 ) may have a tapered shape that narrows toward the base plate (400). 913,923 ) at the end of the lower opening ( 914,924 ) has a diameter smaller than the diameter of the dry bead, and the lower opening ( 914,924 The bead cannot be discharged to the outside through the bottom opening ( 914,924 ) through the exhaust passage ( 913,923 ) and the fluid melts the dry beads, and the lower opening ( 914,924 ) and can be discharged to the outside (the fluid containing portion of the piston or the amplification module).

[0170] Here, the discharge passage ( 913 ) is the discharge passage ( 923 ) and may narrow towards the base plate (400).

[0171] The first bead chamber (910) is the structure into which the last fluid is introduced before the pre-treated extract is introduced toward the amplification module (600). The fluid introduced into the first bead chamber (910) must be introduced into the receiving part (630) of the amplification module (600) without remaining in the first bead chamber (910) to the maximum extent possible in order to obtain accurate detection results. 913 ) is the discharge passage ( 923 ) and narrows to minimize residual fluid in the first bead chamber (910).

[0172] In addition, the bead chamber 900 according to the present invention has first locking protrusions 903 and 904 extending from the bottom surfaces of the outer partition walls of the first bead chamber 910 and the second bead chamber 920. As shown in Figures 28 and 30, the first locking protrusions 903 and 904 may extend toward the base plate 400 and be formed in a protruding structure toward the outside.

[0173] The outer chamber (100) that engages with the bead chamber (900) has a second locking protrusion ( 119 ) is formed, and when a force is applied to the bead chamber (900) toward the base plate (400), the first locking projections (903, 904) lock to the second locking projections ( 119 ), the first locking projections (903, 904) engage with the second locking projections ( 119 ), the relative position of the bead chamber (900) to the outer chamber (100) is fixed.

[0174] The extraction method according to the embodiment of the present invention will be specifically described below.

[0175] First, (a) the inner chamber engages with the outer chamber through the upper openings of the first spaces of the outer chamber, and the fixing portion of the inner chamber preferably engages with the outer chamber while engaging with the inner chamber engaging portion of the safety clip.

[0176] Next, (b) the cover is engaged with the outer chamber, and (c) the safety clip is removed from the outer chamber.

[0177] Next, (d) the cover is pressurized, causing the first protruding member formed on the bottom surface of the cover to break the first sealing member sealing the upper opening of the inner chamber, and the second protruding members formed on the bottom surfaces of the multiple first spaces of the outer chamber to break the second sealing members sealing the lower opening of the inner chamber, causing the reagent contained in the inner chamber to flow out into the multiple first spaces, and (e) by driving the driving unit, the reagent that has flowed out into the multiple first spaces is sucked into and mixed in the fluid containing section inside the upper piston, and then the mixed reagent is discharged to the amplification module.

[0178] Step (e) is carried out in multiple steps, which will be described in more detail below. First, (e1) a sample to be analyzed is introduced into one of the plurality of first spaces of the outer chamber through a sample introduction hole of the cover.

[0179] Next, (e2) the piston installed in the piston accommodating portion of the outer chamber rotates, and the liquid port of the piston communicates with the first discharge hole formed on the bottom surface of any one of the first spaces into which the sample to be analyzed has been introduced.

[0180] Next, (e3) the contact part installed in the internal space of the piston rises, and the sample to be analyzed accommodated in any one of the first spaces is sucked into the fluid accommodation part in the external chamber.

[0181] Next, (e4) the piston rotates, and the liquid port of the piston communicates with the first discharge hole formed in the bottom surface of the other first space.

[0182] Next, (e5) the contact portion rises, and the first reagent contained in the other first space is sucked into the fluid containing portion inside the outer chamber, thereby mixing the sample to be analyzed and the first reagent in the fluid containing portion.

[0183] Next, (e6) the piston rotates, and the liquid port of the piston communicates with the first discharge hole formed in the bottom surface of another one of the first spaces.

[0184] Next, (e7) the contact portion rises, and the second reagent contained in the other first space is sucked into the fluid containing portion inside the outer chamber, thereby mixing the sample to be analyzed with the first reagent and the second reagent.

[0185] Next, (e8) the piston rotates, and the filter port of the piston communicates with the first discharge hole formed in the bottom surface of the other first space.

[0186] Next, (e9) the contact part descends, and the mixture contained in the fluid containing part passes through the genome collection filter installed in the filter port and is discharged into the other first space.

[0187] Next, (e10) the piston rotates, and the liquid port of the piston communicates with the first discharge hole formed in the bottom surface of the first space in which the first reagent, the second reagent and other reagents are accommodated.

[0188] Next, (e11) the contact portion rises, and the other reagent is sucked into and mixed with the fluid containing portion.

[0189] Next, (e12) the piston rotates, and the filter port of the piston communicates with the first discharge hole formed in the bottom surface of the first space containing another reagent.

[0190] Next, (e13) the contact part descends, and the mixed liquid contained in the fluid containing part passes through the genome collection filter and is discharged into the first space containing other reagents.

[0191] Next, (e14) the piston rotates, and the liquid port of the piston communicates with the first discharge hole formed in the bottom surface of the first space containing the eluent.

[0192] Next, (e15) the contact part rises, and the eluent is sucked into the fluid storage part.

[0193] Next, (e16) the piston rotates, and the filter port of the piston communicates with the second discharge hole formed in the bottom surface of the first space containing the beads necessary for genome amplification.

[0194] Next, (e17) the contact portion descends, and the eluent contained in the fluid containing portion passes through the genome collection filter and is discharged into the first space containing the beads necessary for genome amplification, and the genomes captured on the genome collection filter are separated from the genome collection filter and discharged together into the first space.

[0195] Next, (e18) the piston rotates, and the liquid port of the piston communicates with the second discharge hole formed in the bottom surface of the first space in which the genome is accommodated.

[0196] Next, (e19) the contact part rises, and the extract containing the genome is sucked into the fluid storage part.

[0197] Next, (e20) the piston rotates, bringing the liquid port of the piston into communication with the amplification module.

[0198] Next, (e21) the contact part is lowered, and the extract containing the genome contained in the fluid containing part is discharged into the amplification module.

[0199] Next, (e22) the extract is introduced into the storage section of the amplification module through the extract transfer passage of the amplification module.

[0200] Next, (e23) the air remaining in the storage section is discharged to the outside of the amplification module through the gas transfer passage of the amplification module.

[0201] Next, (e24) the amplification device applies heat of a predetermined temperature or higher to the storage section, and the genome is amplified.

[0202] Next, (e25) the presence or absence of disease infection in the sample to be analyzed is determined based on the fluorescence intensity of the amplified product of the genome.

[0203] While the present invention has been described above with reference to the embodiments shown in the drawings so that those skilled in the art can easily understand and reproduce the present invention, these are merely illustrative examples, and those skilled in the art will recognize that various modifications and equivalent embodiments are possible from the embodiments of the present invention. Therefore, the scope of protection of the present invention should be determined by the claims. [Explanation of symbols]

[0204] S1: First sealing member S2: Second sealing member S3: Third sealing member S4, S5: Sealing material 100: Outer chamber 100a: Upper outer surface 100b: Lower outer surface 101,102,103,104,105,106,107: 1st space 108: Piston insertion part 109: Landing section 111, 112, 113, 114, 115: second protruding member 111a, 112a, 113a, 114a, 115a: Protrusion 111b, 112b, 113b, 114b, 115b: Blade part 119:Second locking protrusion 121,122,123,124,125: 1st discharge hole 126,127,129:Second discharge hole 128: Air exhaust hole 130: Insertion space 131: Stopper 200: Inner chamber 201,202,203,204,205:Second space 210: Upper inner chamber 220: Lower inner chamber 230: Fixed part 300: Cover 301: Cover body 302: Lid 307: First insertion hole 308: Second insertion hole 311, 312, 313, 314, 315: First protruding member 316, 317: Third protruding member 320: Separation member 400: Base plate 400a: Piston drive part insertion hole 401, 402, 403, 404, 405, 406, 407, 408: Liquid flow path 409: Air flow path 410: Flow cover 410a: 1st through hole 410b: 1st engagement protrusion 410c: Melt protrusion 410d: Second engagement protrusion 411a, 412a, 413a, 414a, 415a, 416a, 417a, 418a: First flow cover hole 411b, 412b, 413b, 414b, 415b: Second flow cover hole 416b, 417b, 418b: 3rd flow cover hole 419a, 419b: 4th flow cover hole 420: Pad 420a: 2nd through hole 421a, 422a, 423a, 424a, 425a, 426a, 427a, 428a: First pad hole 421b, 422b, 423b, 424b, 425b: Second pad hole 426b, 427b, 428b: 3rd pad hole 429a, 429b: 4th pad hole 420c: Engagement groove 500: Safety clip 510: Outer chamber engagement part 520: Handle 530: Upper extension 540: Side extension 541: Cover support member 542: Inner chamber engagement part 600: Amplification module 610: Body 611: One side 612: Opposite side 621,622: Inlet 630: Storage unit 631: Upper 632: Lower 633: Gas exhaust passage 640: Gas transfer passage 641:Communication hole 642: Passageway 643: Storage passage 644: Passage pattern forming section 650:Extract liquid transfer passage 700: Piston 701: Fluid storage section 710: Upper piston 711: Close contact area 711a: Drive unit installation section 712: 1st hole 713: 2nd hole 720: Lower piston 721: Torso 722: Shaft 723: Liquid port 724: Filter port 800: Drive unit 900: Bead chamber 901: 1st bead chamber bulkhead 902: Second bead chamber bulkhead 903,904: 1st locking protrusion 910: 1st bead chamber 911: 1st bead holder 912: 1st dehumidification section 913: 1st discharge passage 914: Lower opening 920: Second bead chamber 921: Second bead holder 922:Second dehumidification section 923:Second discharge passage 924: Lower opening 930: Dehumidifying chamber 1000: Genome extraction device

Claims

1. an outer chamber whose interior is divided into a plurality of first spaces by outer chamber partitions; a bead chamber that engages with the outer chamber through the upper openings of the plurality of first spaces, the interior of which is divided into a plurality of third spaces by bead chamber partitions, and in which beads necessary for genome extraction and amplification are accommodated in the third spaces; and a base plate that engages with a lower portion of the outer chamber and has a plurality of flow channels formed on an upper surface thereof that communicate with the plurality of first spaces; upper openings of the third spaces are covered by third sealing members, and lower openings thereof communicate with the first spaces and the flow paths to form closed flow paths; The plurality of third spaces are a first bead chamber containing first dry beads necessary for genome amplification; and a second bead chamber containing second dry beads necessary for genome extraction; dehumidifying units for dehumidifying the interiors of the third spaces are installed in the third spaces; a diameter of the lower opening of the first bead chamber is smaller than a diameter of the first dry bead, and a diameter of the lower opening of the second bead chamber is smaller than a diameter of the second dry bead; Extraction device.

2. 2. The extraction device according to claim 1, further comprising a cover for covering the upper openings of the plurality of first spaces of the outer chamber, the cover having a third protruding member formed on a bottom surface thereof for breaking the third sealing member.

3. The plurality of third spaces are a dehumidifying chamber disposed between the first bead chamber and the second bead chamber; 3. The extractor according to claim 2, wherein a bead holder is installed inside the first bead chamber and the second bead chamber to prevent the bead from being separated from the third space.

4. a first dehumidifying unit for dehumidifying the inside of the first bead chamber is installed inside the dehumidifying chamber; The extractor according to claim 3 , wherein a second dehumidifying unit for dehumidifying the interior of the second bead chamber is installed inside the second bead chamber.

5. 5. The brewing device of claim 4, wherein a first bead chamber partition separating the first bead chamber and the dehumidifying chamber is provided at a height lower than a second bead chamber partition separating the second bead chamber and the dehumidifying chamber.

6. an upper portion of the second bead chamber partition wall extends to the same height as an upper portion of an outer partition wall forming the second bead chamber; an upper portion of the first bead chamber partition wall extends to a height lower than an upper portion of an outer partition wall forming the first bead chamber; 6. The extraction device of claim 5, wherein when the upper opening of the bead chamber is sealed by the third sealing member, the first bead chamber and the dehumidification chamber communicate with each other through a space between the first bead chamber partition and the third sealing member.

7. 7. The extractor according to claim 6, wherein the lower openings of the first bead chamber and the second bead chamber are formed at the ends of discharge passages that narrow toward the base plate.

8. 8. The extractor of claim 7, wherein the discharge passage of the first bead chamber has a wider diameter than the discharge passage of the second bead chamber and narrows toward the base plate.

9. The extraction device according to claim 8 , wherein a second discharge hole communicating with a flow path formed in the base plate is formed in a bottom surface of the first space communicating with the plurality of third spaces.

10. an upper piston having an open top, a fluid receiving portion formed therein for receiving the fluid discharged through the second discharge hole, and a hole formed in a lower portion thereof in alignment with the second discharge hole; a contact portion that is installed so as to be able to rise and fall inside the fluid storage portion; and 10. The extraction device of claim 9, further comprising a piston comprising: a lower piston engaged with said upper piston and having a liquid port and a filter port formed in a lower portion thereof.

11. a drive portion that passes through the base plate and engages the lower piston; The extraction device according to claim 10, wherein the lower piston is rotated by driving the driving unit, and the liquid port or the filter port communicates with any one of the plurality of first spaces.

12. When the contact portion descends in the fluid receiving portion, the fluid in the fluid receiving portion is discharged to the first bead chamber or the second bead chamber through the liquid port or the filter port, The extraction device according to claim 11 , wherein when the contact portion rises in the fluid containing portion, the fluid contained in the first bead chamber or the second bead chamber is sucked into the fluid containing portion.

13. an inlet engaging said extractor; a storage section which is a space for storing the fluid discharged through the inlet; A gas transfer passage formed on one surface and connecting the inlet and the storage section; and The extraction device according to claim 12, further comprising an amplification module including an extraction liquid transfer passage formed on the opposite surface of the one surface and connecting the inlet and the storage section.

14. a first locking protrusion extending from a bottom surface of an outer partition wall forming the plurality of third spaces is formed; a second locking protrusion is formed on one side of the outer chamber partition wall that divides the outer chamber into a plurality of first spaces; 2. The extractor of claim 1, wherein the first and second locking projections are engaged to fix the relative position of the bead chamber with respect to the outer chamber.

Citation Information

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