KR102061651B1 - Pre-processing apparatus of object and method for pre-processing the object - Google Patents

Abstract

A collection container containing a sample of the user, a cover coupled to the collection container at the top of the collection container, and an agitator coupled to the bottom of the collection container, the collection container having an outlet of the first member and the first member penetrated in the vertical direction; And a second member having a first blocking film on the side and accommodating a chemical substance in the inner space, wherein the cover is formed with a crushing protrusion extending downwardly so that the crushing protrusion crushes the first blocking film when the cover is coupled to the collection container. And a stirrer to agitate the chemically treated sample in a collection vessel, and a sample pretreatment apparatus and a pretreatment method are disclosed.

Description

PRE-PROCESSING APPARATUS OF OBJECT AND METHOD FOR PRE-PROCESSING THE OBJECT}

The present invention relates to the field of sample pretreatment. More specifically, the present invention relates to an apparatus and method for hermetically sealing a sample discharged from a human body or an animal.

Viral infections such as SARS (Severe Acute Respiratory Syndrome), Middle East Respiratory Syndrome (MERS), or Influenza are highly infectious through the respiratory tract with high mortality, so it is important to diagnose them early to prevent further transmission and damage. Do.

Currently, the most commonly used method for detecting viruses is molecular diagnostics, which detects the causes of diseases and whether they are infected by detecting nucleic acids (such as DNA, RNA, or variants thereof) that cause diseases. How to detect. These molecular diagnostic methods take samples from body fluids, sputum, tissue samples, etc., extract the genes of the collected samples, and perform amplification and analysis of genes using polymerase chain reaction (PCR). It consists of.

For effective genetic testing, pretreatment to extract DNA or RNA is essential. The pretreatment includes effectively crushing and homogenizing samples such as saliva, sputum, blood, and tissue samples, and mixing with reagents. At this time, the process of crushing and homogenizing the sample is a pretreatment process that must go through and at the same time entails considerable labor. Moreover, since the crushing and homogenization process directly affects the lysis process, its efficiency and consistency must be ensured. However, the existing pretreatment process requires a lot of labor, but there is a problem that the result is made by hand and the result is not guaranteed to a certain degree. In addition, high-risk specimens present a risk of infection during the pretreatment process, as well as the risk of cross-contamination during the mixing of reagents for pretreatment, requiring special facilities (eg, facilities with guaranteed biosafety levels) and skilled professionals. .

Therefore, there is a need for a technique capable of simply pre-processing a sample for rapid examination.

The present invention has been made to solve the above problems, the object of the present invention is to simply pretreat the sample with low power.

In addition, another object of the present invention is to configure the device for pretreatment in a separate structure to facilitate the replacement of parts.

In addition, another object of the present invention is to implement a test suitable for the specificity of the point of care testing (POCT) by allowing a rapid disease test can be performed.

Technical objects to be achieved in the present invention are not limited to the above-mentioned matters, and other technical problems not mentioned above are provided to those skilled in the art from the embodiments of the present invention to be described below. May be considered.

Sample pretreatment device for solving the above technical problem, a collection container for receiving a sample from the user, a cover coupled to the collection container in the upper portion of the collection container, and a stirrer coupled to the lower portion of the collection container, A second member coupled to the first member penetrating in the up and down direction and a lower portion of the first member, the first member including a first blocking membrane on an outlet side of the first member, and accommodating a chemical substance for melting a sample in an internal space; And a shredding protrusion extending downward in the cover so that the shredding protrusion breaks the first barrier membrane when the cover is coupled to the collecting vessel, and the agitator stirs the chemically treated sample in the collecting vessel.

As the crushing protrusion of the cover crushes the first blocking film, the sample contained in the collection container can move to the inner space of the second member.

The second member may include a blocking member that is formed at a lower portion of the first member and is coupled to the first member, and a first blocking film is detachably coupled to the inside of the case.

A second blocking film is formed below the second member, and when the stirrer is coupled to the collection container, the second blocking film may be broken by the stirrer.

The stirrer and the collection vessel are screwed, but the second blocking membrane may be broken by the screw portion as the threaded portion of the stirrer is screwed into the screw groove of the collection vessel.

The stirrer may include a cylinder penetrated in a vertical direction, a stirring member formed with a plurality of blades positioned inside the cylinder, and a sealing member sealing one side of the cylinder.

A motor is connected to the stirring member or the sealing member, and the stirring member may rotate as the motor is driven.

A sample pretreatment method for solving the above technical problem is a second member that penetrates in the vertical direction and a second member that is coupled to a lower portion of the first member and accommodates a chemical substance for melting a sample from a user in an internal space. Receiving the sample through the collection container made, after receiving the sample, by coupling the cover with a fracture projection extending in the lower direction to the upper portion of the collection container to crush the blocking film formed on the outlet side of the first member, and collecting Coupling a stirrer to the bottom of the collection vessel to agitate the chemically treated sample in the vessel.

A sample pretreatment system for solving the above technical problem includes a first container for collecting a sample from a user, and a second container for pretreating the sample by performing at least one of decontamination, liquefaction, lysis, and nucleic acid extraction. Including, the first container and the second container is integrally coupled, the first container and the second container is hermetically coupled so that the sample is not exposed to the outside.

The sample pretreatment system can chemically and mechanically dissolve the sample.

According to embodiments of the present invention, the following effects can be expected.

Firstly, the treatment of specimens in a simple way ensures the speed and convenience of the pretreatment process.

Second, by replacing the pre-treatment device in a separate structure, the replacement of parts can be easily made, the pre-treatment process is automatically performed through the combination of parts improves the user's convenience of operation.

Third, as the pretreatment device is manufactured, the overall process for the genome test can be made quickly and accurately, thereby ensuring a diagnosis system suitable for the field manifestation test.

Effects obtained in the embodiments of the present invention are not limited to the above-mentioned effects, and other effects not mentioned above are commonly known in the art to which the present invention pertains from the description of the embodiments of the present invention. Can be clearly derived and understood by those who have In other words, unintended effects of practicing the present invention may also be derived by those skilled in the art from the embodiments of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are provided to help understand the present invention, and provide embodiments of the present invention with detailed description. However, the technical features of the present invention are not limited to the specific drawings, and the features disclosed in the drawings may be combined with each other to constitute a new embodiment.
1 is a diagram illustrating a pretreatment apparatus according to an embodiment of the present invention.
FIG. 2 is a diagram showing a cross section of the pretreatment apparatus shown in FIG. 1. FIG.
3 is an exploded view of the cover and the collection vessel of the pretreatment device of FIG. 2.
4 is a cross-sectional view in a state in which a cover and a collection container are combined in the pretreatment apparatus.
5 is an exploded view of the stirrer of the pretreatment apparatus of FIG. 2.
6 is a cross-sectional view of the stirrer in the pretreatment apparatus.
7 is a flowchart illustrating a preprocessing method according to an embodiment of the present invention.

DETAILED DESCRIPTION Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the art may easily implement the present invention. As those skilled in the art would realize, the described embodiments may be modified in various different ways, all without departing from the spirit or scope of the present invention. In the drawings, parts irrelevant to the description are omitted in order to clearly describe the present invention, and like reference numerals designate like parts throughout the specification.

Terms used herein will be briefly described and the present invention will be described in detail.

The terms used in the present invention have been selected as widely used general terms as possible in consideration of the functions in the present invention, but this may vary according to the intention or precedent of the person skilled in the art, the emergence of new technologies and the like. In addition, in certain cases, there is also a term arbitrarily selected by the applicant, in which case the meaning will be described in detail in the description of the invention. Therefore, the terms used in the present invention should be defined based on the meanings of the terms and the contents throughout the present invention, rather than the names of the simple terms.

When any part of the specification is to "include" any component, this means that it may further include other components, except to exclude other components unless otherwise stated. In addition, when a part of the specification is said to be "connected" to another part, this includes not only "directly connected", but also "connected with other elements in the middle".

Hereinafter, with reference to the accompanying drawings will be described in detail the present invention. On the other hand, the "sample" in the present specification means a material that can be discharged to the outside from a human or animal, and may include, for example, extracorporeal substances such as saliva, blood, sputum, sweat, but is not limited thereto. It doesn't happen.

FIG. 1 is a diagram illustrating a pretreatment apparatus 100 according to an embodiment of the present invention, and FIG. 2 is a diagram illustrating a cross section of the pretreatment apparatus 100 illustrated in FIG. 1.

1 and 2, the pretreatment apparatus 100 according to an embodiment of the present invention includes a collection vessel 130, a cover 140, and an agitator, each of which includes a first member 110 and a second member 120. 150 may be included. The stirrer 150 may be separated from the collection vessel 130 and the cover 140 in the pretreatment device 100, depending on the embodiment.

The first member 110 of the collection container 130 is positioned above the second member 120 and penetrates in the vertical direction. The chemical is contained in the inner space of the second member 120. As the sample moves to the second member 120, a chemical reaction between the sample and the chemical may proceed. The chemical contained in the second member 120 serves to lower the viscosity of the sample by releasing and melting the polymer of the sample, thereby facilitating the extraction of DNA or RNA from the sample combined with the chemical. These chemicals include sodium hydroxide (NaOH), sodium bicarbonate, N-acetyl-L-cysteine (NALC), dithiothreitol (DTT), etc., for the liquefaction of samples. 100, Triton X-114, Nonyl phenoxypolyethoxylethanol (NP-40), Polyethylene glycol hexadecyl ether (Brij-35, Brij-58), Polyethylene glycol sorbitan monolaurate (Tween 20, Tween 80), Octyl glucoside, Octyl thioglucoside, 3- [ (3-Cholamidopropyl) dimethylammonio] -1-propanesulfonate hydrate (CHAPS), 3-([3-Cholamidopropyl] dimethylammonio) -2-hydroxy-1-propanesulfonate (CHAPSO), sodium dodecyl sulfate (SDS), and sputum At least one of ethanol, isopropanol, chaotropic agents (sodium iodide, sodium perchlorate, guanidinium thiocyanate, guanidinium hydrochloride), silica particles, etc. for extracting nucleic acids such as proteases, Serine Proteases, Proteinase K, Tissue proteases, etc. may be used. One It is not.

When the sample is received in the collection container 130, the cover 140 is coupled to the upper portion of the collection container 130 by the user, and the cover 140 has a crushing protrusion 145 for moving the sample to the second member 120. ) Is formed. The crushing protrusion 145 will be described later.

The stirrer 150 agitates the sample chemically treated in the collection vessel 130. If collection vessel 130 chemically treats the sample (ie, chemical dissolution), stirrer 150 physically processes the sample (ie, mechanical dissolution). For example, when the sample is sputum, it may not be suitable for post-treatment due to its unique viscosity, so that the stirrer 150 may stir the sample to lower the sputum's viscosity.

Since the pretreatment device 100 according to an embodiment of the present invention performs chemical treatment and further physical treatment as soon as the sample is collected from the patient, the following post-treatment process can be performed quickly and easily.

3 is an exploded view of the cover 140 and the collection vessel 130 of the pretreatment apparatus 100 of FIG. 2, and FIG. 4 is a state in which the cover 140 and the collection vessel 130 of the pretreatment apparatus 100 are coupled to each other. It is a cross section of.

As shown in FIGS. 3 and 4, the first member 110 may have a shape in which the diameter of the outlet side B is smaller than the diameter of the inlet side A, thereby easily collecting a sample of the patient. can do. The side of the first member 110 is formed with a jaw portion 112 protruding in the lateral direction, when the cover 140 and the second member 120 is coupled to the first member 110, the cover 140 The end of the and the end of the second member 120 may be in contact with the jaw portion (112). The first member 110 and the cover 140, and the first member 110 and the second member 120 may be screwed, respectively.

The second member 120 may include a case 122 and a blocking member 124, and the blocking member 124 may be detachably coupled to the inside of the case 122. The blocking member 124 may be coupled to the case 122 by being seated in the groove 128 formed inside the case 122. The blocking member 124 may be located at the exit side B of the first member 110 and the first blocking layer 126 may be formed. In addition, a second blocking layer 127 may be formed under the case 122, and the chemical may be accommodated in the space C between the first blocking layer 126 and the second blocking layer 127.

On the other hand, according to the embodiment, the second member 120 may be made of only the case 122, the first blocking film 126 is formed inside the case 122, the above-described blocking member 124 is omitted Of course, it can also be implemented.

When the sample is accommodated in the first member 110, the sample may not be moved to the internal space C of the second member 120 by the first blocking layer 126. However, when the cover 140 is coupled to the upper portion of the first member 110 after the sample is received, the shredding protrusion 145 of the cover 140 crushes the first blocking film 126, so that the sample is the second member ( The inner space C of the 120 is moved. The movement of the sample into the internal space C of the second member 120 may be performed by gravity applied to the sample, or may be made faster by the user applying an artificial force to the pretreatment device 100.

According to one embodiment, although not shown in Figure 4 between the upper and lower ends of the crushing projection 145 has a diameter corresponding to at least the inner diameter of the first member 110 and the specimen carrying member surrounding the crushing projection 145 May be located. This sample carrying member may be formed of rubber or silicone, for example. The specimen such as sputum may be adhered to the inner wall of the first member 110 due to its unique viscosity. The specimen carrying member may be attached to the first member 110 when the cover 140 is coupled to the first member 110. The sample adhered to the inner wall of the 110 is pushed downward to forcibly move to the second member 120.

Subsequently, the user couples the stirrer 150 to the second member 120 for physical treatment of the specimen. A screw groove 129 for coupling with the stirrer 150 may be formed inside the second member 120. Can be.

5 is an exploded view of the stirrer 150 of the pretreatment apparatus 100 of FIG. 2, and FIG. 6 is a cross-sectional view of the stirrer 150 of the pretreatment apparatus 100.

The stirrer 150 may include a cylinder 152 penetrated in the vertical direction, a stirring member 154 positioned inside the cylinder 152, and a sealing member 156 sealing one side of the cylinder 152.

A threaded portion 151 for coupling with the second member 120 may be formed at an outer upper portion of the cylinder 152, and the threaded portion 151 may be a screw groove 129 of the second member 120 illustrated in FIG. 4. ) Can be screwed together. Previously, it has been described that the second blocking film 127 is formed at the lower end of the second member 120, but the threaded portion 151 of the cylinder 152 is formed by the screwing of the cylinder 152 and the second member 120. 2 The blocking film 127 can be broken. Accordingly, the sample chemically treated by the second member 120 may move into the cylinder 152 according to gravity or a force by the user.

A plurality of blades 153 and 155 are formed in the stirring member 154, and as shown in FIG. 6, the blades 153 and 155 may include at least one of the spiral blade 153 and the blade-shaped blade 155. It may include.

The sealing member 156 is coupled to the lower portion of the cylinder 152 so that the agitated specimens inside the cylinder 152 are not discharged to the outside. In one embodiment, the sealing member 156 has a luer lock structure. 152 can be sealed. The stirring member 154 may be screwed into a groove formed in the sealing member 156.

When the sample is moved and received from the second member 120 into the cylinder 152, the user may directly shake the stirrer 150 repeatedly to lower the viscosity of the sample. Alternatively, even if the user does not directly shake the stirrer 150, if the sample moves to the lower portion of the cylinder 152 according to gravity, the sample collides with the blades 153 and 155 formed on the stirring member 154 to form a coupling structure of the polymers of the sample. The viscosity may be degraded by separation.

In some embodiments, a motor (not shown) may be connected to the sealing member 156 or the stirring member 154 to cause the stirring member 154 to rotate inside the cylinder 152. In FIG. 6, reference numeral 157 shows a groove 157 to which a motor can be coupled. The sealing member 156 must be rotatably coupled to the cylinder 152 when the motor is connected to the sealing member 156, whereas only the stirring member 154 is the cylinder when the motor is directly connected to the stirring member 154. 152 may be rotated inside.

Once the physical processing of the sample is complete (ie, when the sample is fused), the user may detach the sealing member 156 from the cylinder 152 to extract DNA and RNA from the sample, or the stirrer 150 itself may be a second member. It can be separated from the 120 to discharge the sample to the outside. Alternatively, even if the stirrer 150 or the cylinder 152 is not opened according to the above-described manner, the cylinder 152 is passed through the sealing member 156 through a means for collecting a physically processed sample (for example, a syringe). It is also possible to obtain a processed sample by inserting it inside.

Meanwhile, the pretreatment apparatus 100 and related components illustrated in FIGS. 1 to 6 may be manufactured according to a 3D printing method that is easy to manufacture a prototype and enables a detailed form of a product. For example, the pretreatment apparatus 100 may be manufactured using a 3D printer using a stearolithography apparatus (SLA) method. The SLA method means a method of curing by projecting a laser on a photocurable liquid resin. Alternatively, the pretreatment apparatus 100 may be manufactured by extruding plastic. The above-described pretreatment apparatus 100 and related components may be made of a polypropylene material and an ABS material that can be precisely outputted with high stress among materials used in the SLA method. Alternatively, the pretreatment device 100 and related components may be output in a SLA method and may be made of a special resin (resin) material having strength and precision comparable to those of polypropylene and ABS.

7 is a flowchart illustrating a preprocessing method according to an embodiment of the present invention.

In operation S710, a sample of the user (eg, the user's body) is collected through the collection container 130 including the first member 110 penetrated in the vertical direction and the second member 120 containing the chemical material in the internal space. Extracorporeal).

As described above, the second member 120 may be formed with the first blocking layer 126 and the second blocking layer 127 positioned below the first blocking layer 126. Chemicals may be accommodated in the spaces between the second blocking layers 127.

In operation S720, when the specimen is accommodated in the collection container 130, the cover 140 is coupled to the upper portion of the collection container 130. The cover 140 is formed with a crushing protrusion 145 extending downward, and when the cover 140 is coupled to the collection container 130, the crushing protrusion 145 crushes the first blocking film 126. As the first blocking layer 126 is crushed, the sample moves to the inner space of the second member 120 to cause a chemical reaction with the chemical substance.

In step S730, the stirrer 150 is coupled to the lower portion of the collection vessel 130. As the stirrer 150 is coupled to the collection vessel 130, the second blocking membrane 127 of the second member 120 is crushed, and the chemically treated sample moves to the stirrer 150. In the agitator 150, the physical treatment of the sample is performed, and after the physical treatment is completed, the sample may be discharged to the outside to proceed with subsequent treatment.

As such, the pretreatment apparatus 100 according to an embodiment of the present invention may allow rapid post-treatment (for example, PCR test) to proceed by chemically and physically treating a sample collected from a patient in a simple manner. have. In addition, the pretreatment apparatus 100 may be manufactured in a detachable structure composed of several parts, so that the parts may be easily combined.

The foregoing description of the present invention is intended for illustration, and it will be understood by those skilled in the art that the present invention may be easily modified in other specific forms without changing the technical spirit or essential features of the present invention. will be. Therefore, it should be understood that the embodiments described above are exemplary in all respects and not restrictive. For example, each component described as a single type may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined form.

The scope of the present invention is shown by the following claims rather than the above description, and all changes or modifications derived from the meaning and scope of the claims and their equivalents should be construed as being included in the scope of the present invention. do.

100: pretreatment device 110: first member
112: jaw portion 120: second member
122: case 124: blocking member
126: first blocking film 127: second blocking film
128; Groove 129: screw groove
130: collection container 140: cover
145: crushing projection 150: stirrer
151: screw portion 152: cylinder
153: spiral blade 154: stirring member
155: wing blade 156: sealing member
157: home

Claims (10)

A collection container for holding a sample from a user;
A cover having a crushing protrusion coupled to the collection container at an upper portion of the collection container and extending in a downward direction; And
Including a stirrer coupled to the lower portion of the collection vessel,
The collection container,
A first member penetrated in the vertical direction; And
A second member coupled to a lower portion of the first member, having a first blocking film on an outlet side of the first member, and accommodating a chemical for melting the sample in an inner space;
The crushing protrusion is provided with a sample carrying member having a diameter corresponding to at least the inner diameter of the first member and formed to surround the crushing protrusion,
As the sample is accommodated in the collection container through the inlet of the first member, the first blocking film prevents the sample from entering the internal space of the second member, and the cover on the upper portion of the first member. As the first blocking film is crushed in accordance with the downward movement of the crushing projection is coupled, the sample of the first member is moved to the internal space of the second member by the sample carrying member in accordance with the crushing of the first blocking film,
A second blocking film is formed below the second member, and the second member and the stirrer are screwed together, and the screw unit provided in the stirrer is screwed into the screw groove provided in the second member. The second blocking film is crushed by the screw part, and the sample in the second member is moved to the stirrer according to the crushing of the second blocking film, and the stirrer is a sample chemically treated by the chemical in the second member. Specimen pretreatment device, characterized in that for stirring. delete The method of claim 1,
The second member,
A case coupled to the first member at the bottom of the first member; And
Sample pre-treatment device is characterized in that the first blocking film is formed and consists of a blocking member detachably coupled inside the case. delete delete The method of claim 1,
The stirrer,
A cylinder penetrated in the vertical direction;
A stirring member having a plurality of blades formed therein and positioned inside the cylinder; And
Specimen pretreatment device, characterized in that consisting of a sealing member for sealing one side of the cylinder. The method of claim 6,
A sample is connected to the stirring member or the sealing member, and a motor is connected to the sample pretreatment, characterized in that the stirring member rotates as the motor is driven. delete delete delete

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