WO2019164187A1

WO2019164187A1 - Sealing/stirring-type specimen treatment device and method for operating same device

Info

Publication number: WO2019164187A1
Application number: PCT/KR2019/001855
Authority: WO
Inventors: 이민영; 기창석; 정병호; 허희재; 박현주; 우아영
Original assignee: 사회복지법인 삼성생명공익재단
Priority date: 2018-02-22
Filing date: 2019-02-14
Publication date: 2019-08-29
Also published as: KR102061656B1; KR20190101143A

Abstract

One embodiment of the present invention provides a sealing/stirring-type specimen treatment device. The sealing/stirring-type specimen treatment device may comprise: a collection container for receiving a specimen; a stirrer connected to the collection container; a rotation driving portion for inducing a rotation of the specimen inside the stirrer; a switch portion for controlling an operation of the rotation driving portion; and a power supply portion for applying power to the rotation driving portion.

Description

Hermetic stirring sample processing device and operation method of the device

The present invention relates to a sealed stirred sample processing device and a method of operating the device. More particularly, the present invention relates to a method of operating the device by sealing a sample discharged from a human body or an animal in a collecting container, and then mechanically dissolving or liquefying the sample by stirring. An apparatus for processing and a method of operating the apparatus.

Acute respiratory infections account for about half of all outbreaks based on US statistics and estimates in Korea, and the highest morbidity and mortality rates are reported worldwide. Diseases such as SARS and MERS, which have relatively low mortality but are at high risk of large-scale epidemics, and SARS and MERS, which are high in mortality and high-risk epidemics, are caused by influenza or coronaviruses. Since these diseases are transmitted through the respiratory tract and are highly contagious, it is important to be diagnosed early to prevent further transmission and damage.

Recently, new and re-emergent respiratory infections have appeared internationally due to the increase in the floating population due to environmental changes and the development of transportation, and the possibility of inflow into the country is increasing continuously. Korea's social alertness against respiratory diseases, which emerged from the 2009 pandemic, has been increasing in recent years.

For high-risk samples, not only are there risks of infection at the pretreatment stage, but also the risk of cross-contamination in the mixing of reagents for pretreatment is necessary, so treatment by special facilities (biosafety levels) and skilled professionals is essential. . Special facilities are often located in large hospitals or laboratories, so point-of-care testing (POCT) of high-risk specimens has practical limitations. Sample pretreatment methods currently used in most laboratories require the preparation of reagents every day, as well as the hassle of repeatedly performing vortex, centrifugation, and the like.

The present invention relates to a closed stirred sample processing device, to eliminate the infectivity in the pre-treatment process of the sample for the on-site diagnosis of acute respiratory infectious disease and to be able to process the sample immediately under low power environment (low power) environment .

As an embodiment of the present invention, a closed stirred sample processing device and a method for pretreatment of a sample using the device may be provided.

In the sealed stirring sample processing device according to an embodiment of the present invention, a collection container in which a sample is accommodated, a stirrer connected to the collection container, a rotary drive unit for inducing rotation of the sample in the stirrer, for controlling the operation of the rotary drive unit. A power supply unit for applying power to the switch unit and the rotary drive unit may be included.

Collection container according to an embodiment of the present invention is connected to the upper side of the stirrer, the sample may be introduced downward from the collection vessel into the stirrer as the collection vessel and the stirrer is connected.

Agitator according to an embodiment of the present invention is a cylindrical shape having a rotary blade therein, the upper side of the blade includes at least one spiral blade and at least one first protruding blade surrounded by a spiral blade, the lower side of the blade At least one second protruding blade may be included that extends adjacent to the inner side of the stirrer.

The lower end of the blade according to an embodiment of the present invention may include a first magnetic portion for receiving a rotational force applied from the rotation driving unit.

In addition, one end of the rotary drive unit according to an embodiment of the present invention may include a second magnetic portion that is electromagnetically connectable with the first magnetic portion.

The lower end of the stirrer according to an embodiment of the present invention is provided with a plurality of sealing members, the stirrer may be disposable.

In the method for pretreatment of a sample using the sealed stirred sample processing device according to an embodiment of the present invention, the step of receiving the sample into the interior of the collection container, connecting the collection container containing the sample to the stirrer, the stirrer rotary drive unit The method may include connecting to an included housing, operating a rotary drive unit to mechanically dissolve or liquefy the sample in the agitator, and extracting the dissolved or liquefied sample from the agitator.

By using the sealed agitated sample processing device according to an embodiment of the present invention, it is possible to diagnose acute respiratory infections. In other words, it is possible to remove the infectivity during the pretreatment of the sample for the field diagnosis and to process the sample immediately under a low power environment.

A simple pretreatment of the sample is possible without the need for processes such as vortex and centrifugal sedimentation in a laboratory attached to a conventional medical institution. This helps to ensure efficient operation of laboratories in laboratories and to ensure work safety for personnel (eg, prevention of infection exposure during testing). It also helps in the on-site diagnosis of tests that were performed only in the central laboratory due to the risk of infection.

In addition, by manufacturing the stirrer for single use in accordance with one embodiment of the present invention to lower the manufacturing and maintenance cost, it helps the user to more quickly process the sample more conveniently.

According to one embodiment of the present invention, since the sample can be preprocessed by a simple manipulation method after collecting the sample, anyone can use the device on time regardless of the user's skill.

By visiting large hospitals equipped with various testing facilities to check for respiratory diseases, it is possible to effectively prevent secondary infections that may occur, and to secure national health stability by actively controlling and preventing national disasters.

1 is a block diagram of a sealed stirred sample processing device according to an embodiment of the present invention.

Figure 2 shows (a) a perspective view, (b) a side view (partly perspective), (c) a schematic exploded view of a sealed stirred sample processing apparatus according to an embodiment of the present invention.

3 is a diagram illustrating a coupling state and an operation process of a first magnetic part and a second magnetic part according to an exemplary embodiment of the present invention.

4 shows a schematic exploded view of a stirrer according to an embodiment of the present invention.

5 shows an embodiment of the hermetically sealed agitated sample processing device according to an embodiment of the present invention.

Figure 6 is a flow chart showing a method of pre-treatment of the sample using the hermetically sealed stirred sample processing apparatus 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, the terms "... unit", "module", etc. described in the specification mean a unit for processing at least one function or operation, which may be implemented in hardware or software or a combination of hardware and software. . In addition, when a part of the specification is "connected" to another part, this includes not only "directly connected", but also "connected with other elements in the middle".

Throughout the specification, a "user" may be a medical professional, such as a doctor (eg, a clinician), a clinician, a radiologist, a medical personnel as well as an emergency worker who handles a medical device and a technician who repairs a medical device. Does not. In other words, it means that the user includes all who can handle the device.

As used herein, the term "sample" refers to a substance that can be discharged to the outside from a person or animal, and may include, for example, an extracorporeal substance such as saliva, blood, sputum, and sweat, but is not limited thereto. It doesn't happen.

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

1 is a block diagram of a sealed stirred sample processing device according to an embodiment of the present invention, Figure 2 is a (a) perspective view, (b) a side view of the sealed stirred sample processing device according to an embodiment of the present invention ( Partial perspective), (c) shows a schematic exploded view.

Testing of current clinical specimens (eg, sputum, in vitro) is performed by collecting sputum from a patient in a 50 mL falcon tube, removing the lid from the biosafety level facility, processing the reagents, followed by vortexing and centrifugation. have. In the case of tuberculosis diagnosis, downed cells are collected, and the medium is put in, and the diagnosis is performed by bacterial culture. When genome diagnosis is needed, a task is performed to extract DNA or RNA from liquefied and inactivated sputum and diagnosed by PCR. Although automated PCR has been developed, it is still not readily and quickly applied in the field diagnosis due to the infectivity of the pretreatment parts.

In order to make the sample immediately from the pretreatment of the sample, the sample receiving part should be configured in a sealed type so that there is no risk of transmission during the test and it should be disposable.

In addition, in the case of sputum in patients with respiratory infections, chemical liquefaction or lysis alone may not be effective. For mechanical liquefaction or lysis, the shredder (eg, blade, etc.) can be properly moved by an external motor. If the shredder is directly connected to the motor, it is difficult to manufacture a closed system and cannot completely block (remove) secondary infectivity from the sample.

According to one embodiment of the present invention, a closed mechanical pretreatment of sputum is possible, and for this purpose, a sealing design for sealing, immediate mechanical pretreatment in the field using low power, promotion of rotational movement of a blade, etc. using magnetic, disposable structure Intuitive operation through quick detachable (disconnect) design, switch button, etc. is possible.

The sealed stirring sample processing apparatus 1000 according to an embodiment of the present invention includes a collection container 1100 in which a sample is accommodated, an agitator 1200 connected to the collection container, and a rotation for inducing rotation of a sample in the agitator. The driving unit 1300, a switch unit 1400 for controlling the operation of the rotary driver, and a power source 1500 for applying power to the rotary driver may be included. As shown in FIG. 2, the rotation driving unit 1300, the switch unit 1400, the power supply unit 1500, and the like may be included in the housing 1600.

The collection container 1100 includes a first member and a second member. The first member is positioned above the second member and penetrates in the vertical direction. The chemical is contained in the inner space of the second member, and the chemical reaction between the sample and the chemical may proceed as the sample moves to the second member. The chemical contained in the second member 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 bound to 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) 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. Evan When not restricted.

The stirrer 1200 agitates the chemically treated sample in the collection vessel 1100. If the collection vessel 1100 chemically processes (eg, chemically dissolves) the sample, the stirrer 1200 may physically process (eg, mechanically dissolve) the sample. For example, when the sample is sputum, it may not be suitable for post-treatment due to its unique viscosity, so that the stirrer 1200 may mix the sample to lower the viscosity of the sputum. The device according to one embodiment of the present invention immediately performs chemical and physical treatments as soon as the sample is collected from the patient, thereby allowing the post-treatment process on the sample to proceed relatively quickly and easily.

Collection container 1100 according to an embodiment of the present invention is connected to the upper side of the stirrer 1200, the sample from the collection vessel 1100 to the stirrer 1200 as the collection vessel 1100 and the stirrer 1200 is connected Can be introduced downwards.

The user may combine the collection vessel 1100 with the stirrer 1200 for physical treatment of the specimen, the screw groove for coupling with the upper portion of the stirrer 1200 has a lower end (eg, a second) of the collection vessel 1100 Member) may be formed in advance. In other words, the outer threaded grooves on the upper side of the stirrer 1200 may be correspondingly preformed to engage the inner threaded grooves of the collection vessel 1100.

2, the agitator 1200 according to an embodiment of the present invention has a cylindrical shape having a rotary blade therein, and is surrounded by at least one spiral blade 1210 and a spiral blade 1210 on an upper side of the blade. At least one first protruding blade 1220 may be included, and a lower side of the blade may include at least one second protruding blade 1230 extending to be adjacent to an inner side surface of the stirrer 1200. The spiral blade 1210, the first protruding blade 1220, and the second protruding blade 1230 may be configured to facilitate fracture and mechanical dissolution of the specimen. The sample introduced into the stirrer 1200 is primarily crushed and dissolved through the spiral blade 1210 and the first protruding blade 1220, and moved downward to be crushed secondly by the second protruding blade 1230. Can be dissolved. The sample crushed in the stirrer 1200 may be agitated in the stirrer 1200 by the rotational movement of the rotary drive unit 1300.

The rotation driving unit 1300 according to an embodiment of the present invention may be a motor or the like that can operate in a low power environment.

In addition, the switch unit 1400 may be a switch of a push method, a toggle method, or the like, and an appropriate switch determined in advance and determined according to a stirring method (eg, stirring time, stirring speed, etc.) may be mounted in the apparatus 1000. have.

According to an embodiment of the present invention, the power supply unit 1500 may be a replaceable battery. Such a battery may be a secondary battery such as a primary battery, a rechargeable nickel-cadmium, lithium ion, nickel-hydrogen, or lithium polymer.

3 is a view illustrating a coupling state and an operation process of a first magnetic part and a second magnetic part according to an embodiment of the present invention, and FIG. 4 is a schematic exploded view of an agitator according to an embodiment of the present invention. 5 shows an embodiment of the hermetically sealed agitated sample processing device according to an embodiment of the present invention.

The lower end of the blade according to an embodiment of the present invention may include a first magnetic portion 1240 for receiving the rotational force applied from the rotation driving unit 1300. In addition, one end of the rotation driving unit 1300 according to an embodiment of the present invention may include a second magnetic portion 1310 which is electromagnetically connectable with the first magnetic portion 1240.

2 and 3, the stirrer 1200 may be connected to the rotary driving unit 1300, and the first magnetic unit 1240 of the stirrer 1200 may have a second magnetic unit provided at one end of the rotary driving unit 1300. And magnetically connected to 1310. In other words, as shown in FIG. 3, the first magnetic part 1240 and the second magnetic part 1310 may be formed of magnets and permanent magnets of the N pole and the S pole, respectively, and the first magnetic part 1240. ) And the second magnetic part 1310 may be coupled to each other. Since the first magnetic part 1240 and the second magnetic part 1310 may naturally be mutually coupled to each other, the user may not necessarily align the stirrer 1200 to be accurately placed on the rotational drive part 1300 of the housing 1600. none.

According to the combination of the first magnetic part 1240 and the second magnetic part 1310, the rotational movement of the rotary driver 1300 may be transmitted to the stirrer 1200, and the stirrer 1200 may rotate stably. . Accordingly, in the stirrer 1200, the sample may be mechanically dissolved or liquefied.

The arrangement form of the first magnetic part 1240 of FIG. 4 is an example for description, and is not necessarily limited to this.

Referring to FIG. 2, a plurality of sealing members (eg, 1251, 1253, 1255, etc.) are provided at a lower end of the agitator 1200 according to an embodiment of the present invention, and the agitator may be disposable. According to one embodiment of the present invention, the apparatus 1000 is provided with a plurality of sealing members, thereby eliminating the possibility of accidental leakage of the specimen. In other words, airtightness is intensified. The sealing member may be made of a material having a contamination prevention function such as a rubber packing or a silicon gasket.

In the method for pretreatment of a sample using the sealed stirred sample processing device according to an embodiment of the present invention, the step of receiving the sample into the interior of the collection container (S100), the step of connecting the collection container containing the sample to the stirrer (S200) Connecting the stirrer to the housing including the rotary drive (S300), operating the rotary drive to mechanically dissolve or liquefy the sample in the stirrer (S400) and the dissolved or liquefied sample is extracted from the stirrer (S500) ) May be included.

After the sample is collected in the first member of the collection container 1100 of the specimen, when the lid of the upper end of the collection container 1100 is closed, the lysis reagent and the sample contained in the second member may be mixed. A valve or the like is provided between the first member and the second member, and the dissolution reagent may be contained in advance in the second member space. Such valves and the like can be destroyed as the lid is closed.

After connecting the collection vessel 1100 with the stirrer 1200, the stirrer 1200 to which the collection vessel 1100 is coupled may be mounted to the housing 1600. As described above, the stirrer 1200 may be mounted on the rotation driving unit 1300 of the housing 1600.

By operating the rotary drive unit 1300, the sample may be mechanically dissolved or liquefied inside the stirrer 1200. Such mechanical dissolution or liquefaction may be performed differently depending on the type of sample, the sample treatment method (eg, stirring speed, stirring time, etc.).

After dissolving or liquefying the sample, the stirrer 1200 may be separated from the housing 1600, and the dissolved or liquefied sample may be extracted from the stirrer 1200. For example, a sample may be collected by opening a lid of the collection container 1100 or a sample may be collected using a syringe or the like in a rubber packing portion provided on the lid of the collection container 1100. In addition, after separating the collection vessel 1100 from the stirrer 1200, the sample may be collected from the open stirrer 1200.

With regard to a method of operating a device according to an embodiment of the present invention, the above description may be applied. Therefore, with regard to the method, the description of the same contents as those of the above-described apparatus is omitted.

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.

Claims

As a sealed stirring sample processing device,

A collection container in which the sample is accommodated;

An agitator connected with the collection vessel;

A rotation driving unit for inducing rotation of the specimen inside the stirrer;

A switch unit for controlling the operation of the rotary driver; And

Sealed agitated sample processing device, characterized in that it comprises a power supply for applying power to the rotary drive.
The method of claim 1,

The collection container is connected to the upper side of the stirrer, and the sample is in a closed stirring type sample processing device characterized in that the sample flows downward from the collection vessel to the stirrer as the collection vessel and the stirrer is connected.
The method of claim 1,

The stirrer is a cylindrical shape having a rotary blade therein,

An upper side of the blade includes at least one spiral blade and at least one first protruding blade surrounded by the spiral blade,

Closed agitated sample processing apparatus, characterized in that the lower side of the blade includes at least one second protruding blade formed to extend adjacent to the inner surface of the stirrer.
The method of claim 3, wherein

The lower end portion of the blade includes a first magnetic portion for receiving the rotational force applied from the rotation driving unit,

One end of the rotary drive unit is sealed agitated sample processing device, characterized in that it comprises a second magnetic portion that is electromagnetically connectable with the first magnetic portion.
The method of claim 1,

The lower end of the stirrer is provided with a plurality of sealing members, the stirrer is a closed stirring sample processing device, characterized in that the disposable.
As a method of pretreatment of a sample using a closed stirred sample processing device,

Receiving a sample into the collection container;

Connecting the collection vessel containing the sample to a stirrer;

Connecting the stirrer to a housing including a rotary driver;

Operating the rotary drive unit to mechanically dissolve or liquefy the sample inside the stirrer; And

And dissolving or liquefying the sample from the stirrer.