WO2020262991A1 - Dispositif de collecte pour biopsie liquide - Google Patents

Dispositif de collecte pour biopsie liquide Download PDF

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Publication number
WO2020262991A1
WO2020262991A1 PCT/KR2020/008295 KR2020008295W WO2020262991A1 WO 2020262991 A1 WO2020262991 A1 WO 2020262991A1 KR 2020008295 W KR2020008295 W KR 2020008295W WO 2020262991 A1 WO2020262991 A1 WO 2020262991A1
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WO
WIPO (PCT)
Prior art keywords
reagent
sample
sample collection
liquid biopsy
reagent receiving
Prior art date
Application number
PCT/KR2020/008295
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English (en)
Korean (ko)
Inventor
신동직
김경식
Original Assignee
(주) 메디젠휴먼케어
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by (주) 메디젠휴먼케어 filed Critical (주) 메디젠휴먼케어
Publication of WO2020262991A1 publication Critical patent/WO2020262991A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples

Definitions

  • the present invention relates to a liquid biopsy collection device for diagnosing physiological changes or disease onset of a test subject, and in more detail, a sample of bodily fluid is collected from a subject to be tested and conveniently mixed and stored with a storage reagent at a desired time. It relates to a liquid biopsy collection device that enables this.
  • genetic information is generally obtained through a genetic test in which a body fluid sample such as blood or saliva of a subject is collected and extracted from blood or saliva.
  • sample collection container designed to utilize bodily fluid samples such as blood or saliva has been used, but the sample collection container used to date is usually small in diameter, making it inconvenient for the subject to directly discharge bodily fluid samples into the sample collection container. Of course, there is a problem that a bodily fluid sample may leak out of the sample collection container, which is unsanitary.
  • the conventional sample collection container had to prepare a preservation reagent after collecting the bodily fluid sample and separately inject it into the sample collection container. Accordingly, the conventional sample collection container has a problem that the entire inspection process is cumbersome and there is a high possibility that the preservation reagent will be lost. Had.
  • the present invention is an invention conceived to solve the problems of the prior art described above, eliminating the hassle of separately injecting a preservation reagent after collecting a bodily fluid sample, and collecting a bodily fluid sample from a subject to be tested,
  • the present invention relates to a liquid biopsy collecting device that enables simple mixing and storage to further improve test accuracy.
  • the liquid biopsy collecting device of the present invention for achieving the above object includes a sample collection unit having a hollow with an upper and lower opening formed therein, and into which a body fluid sample of a test subject is injected into the open upper side of the hollow.
  • a reagent storage unit including a member, wherein the sample collection unit is provided at a predetermined position in the hollow, and divides the hollow into a sample storage space in which the bodily fluid sample is stored and an insertion space into which the reagent receiving part is inserted, Further comprising a breaking module for breaking the shielding member when the reagent receiving portion is inserted into the insertion space by a predetermined depth or more.
  • the breaking module may include a breaking member having at least a part protruding toward the insertion space so as to break the shielding member, and a fixing member fixing the breaking member in the hollow.
  • the fracture member may be formed in a ring shape spaced apart from the inner circumferential surface of the sample collection part by a predetermined distance, and the length protruding toward the insertion space may gradually increase from one side to the other side.
  • the breaking module may further include a breaking auxiliary member connected to a lower portion of the fixing member and provided inside the breaking member so that the breaking area of the shielding member broken by the breaking member is downward.
  • the fixing member may include a first support bar provided in a shape crossing the inside of the hollow and a second support bar provided in a shape crossing the inside of the hollow so as to cross the first support bar.
  • sample collection unit may further include an extension portion connected to an upper portion of the sample collection unit to extend the length of the sample storage space, and formed to gradually increase a cross-sectional area of the sample storage space from the bottom to the top.
  • sample collection unit and the expansion unit may be formed to be selectively coupled and separated from each other.
  • the present invention may further include a first shielding cover provided to selectively shield the upper portion of the expansion portion.
  • it may further include a second shielding cover provided to selectively shield the upper portion of the sample collection unit.
  • the sample collection unit further includes a connection portion including an extension region extending a predetermined length from a lower end of the sample collection portion to a lower portion thereof to extend the length of the insertion space, and the reagent storage unit encloses a lower portion of the reagent receiving portion. It may further include a coupling portion connected to the reagent receiving portion so as to form a clearance space between the reagent receiving portion and the connection portion is inserted.
  • connection part may include a first hook protruding outward from a lower end of the extension region, and the coupling part may include a second hook protruding inward so as to be engaged with the first hook.
  • outer circumferential surface of the extension area and the inner circumferential surface of the coupling part are each formed with threads that engage with each other, so that the sample collection unit and the reagent storage unit can adjust the depth at which the reagent receiving part is inserted into the insertion space according to their relative rotation. Can be formed.
  • the present invention may further include a stopper unit that is selectively coupled to the extension region and is fitted between the sample collection unit and the coupling unit to limit the maximum insertion depth of the reagent receiving unit.
  • the shielding member may be bonded to the upper circumference of the reagent receiving portion by a PTP (Press Through Pack) packaging method.
  • PTP Pressure Through Pack
  • the shielding member may be bonded to the upper circumference of the reagent receiving portion in the form of a linear low density polyethylene (LLDP) film.
  • LLDP linear low density polyethylene
  • the shielding member may have a powder-type polyethylene (PE) bonded to the upper circumference of the reagent receiving portion in the form of a film.
  • PE powder-type polyethylene
  • the shielding member may further include an aluminum component.
  • the liquid biopsy collection device of the present invention for solving the above problems can easily collect bodily fluid samples collected from a subject to be tested, and the collected bodily fluid samples are completely sealed so that they can be safely stored during analysis or transport. There is an advantage.
  • the present invention has the advantage that the test process is very simple since it is possible to conveniently mix and store a bodily fluid sample with a preservation reagent at a desired time without the need to separately inject a preservation reagent.
  • the accuracy of the test can be greatly improved by preventing decomposition, decay, and genetic mutation of the bodily fluid sample and the detection module from which the preservation reagent is collected.
  • FIG. 1 and 2 are views showing the appearance of a liquid biopsy collecting device according to a first embodiment of the present invention
  • FIG. 3 and 4 are views showing in detail a state of a fracture module in the liquid biopsy collecting device according to the first embodiment of the present invention
  • FIG. 5 is a view showing in detail the appearance of the reagent storage unit in the liquid biopsy collection device according to the first embodiment of the present invention
  • FIG. 6 is a view showing in detail the state of the stopper unit in the liquid biopsy collection device according to the first embodiment of the present invention.
  • FIG. 7 and 8 are views showing a process of using the liquid biopsy collecting device according to the first embodiment of the present invention.
  • FIG. 9 is a view showing a state of a liquid biopsy collecting device according to a second embodiment of the present invention.
  • FIG. 10 is a view showing a state of a liquid biopsy collecting device according to a third embodiment of the present invention.
  • FIG. 11 is a view showing a state of a liquid biopsy collecting device according to a fourth embodiment of the present invention.
  • the liquid biopsy collection device of the present invention includes a sample collection unit including a sample collection unit in which a cavity with an upper and a lower opening is formed therein, and into which a sample of a body fluid of a test subject is injected into the opened upper side of the hollow.
  • a reagent storage unit including a reagent storage unit that is formed to be inserted into the lower side of the opening and has a reagent storage space having an open upper portion therein, and a shield member that shields the opened upper portion of the reagent storage unit.
  • the sample collection unit is provided at a predetermined position in the hollow, partitioning the hollow into a sample storage space in which the bodily fluid sample is stored and an insertion space into which the reagent receiving part is inserted, and the reagent receiving part is the insertion space It further includes a breaking module for breaking the shielding member when it is inserted beyond a preset depth.
  • FIG 1 and 2 are views showing the appearance of a liquid biopsy collecting device according to a first embodiment of the present invention.
  • Figures 3 and 4 are views showing in detail the appearance of the fracture module 150 in the liquid biopsy collection device according to the first embodiment of the present invention
  • Figure 5 is a liquid according to the first embodiment of the present invention
  • FIG. 6 is a detailed view of the stopper unit 300 in the liquid biopsy collecting device according to the first embodiment of the present invention. It is a figure shown.
  • FIG. 7 and 8 are diagrams showing a process of using the liquid biopsy collecting device according to the first embodiment of the present invention.
  • the liquid biopsy collection apparatus includes a sample collection unit 100, a reagent storage unit 200, and It includes a stopper unit 300 and a first shielding cover 400.
  • the sample collection unit 100 has a hollow having an upper and lower opening therein, and a sample collecting unit 110 into which a sample of the body fluid of the test subject is injected into the open upper side of the hollow, and at a predetermined position in the hollow. It includes a fracture module 150 provided.
  • the rupture module 150 is a sample storage space (S 1 ) in which the bodily fluid sample is stored and an insertion space (S 2 ) into which the reagent receiving part 210 of the reagent storage unit 200 to be described later is inserted It is divided into.
  • the sample referred to herein is a sample of bodily fluid collected from a subject, and includes, but is not limited to, samples such as whole blood, plasma, blood, saliva, urine, sputum, lymph and intercellular fluid.
  • the sample collection unit 100 is connected to the upper portion of the sample collection unit 110 to extend the length of the sample storage space S 1 , but the sample storage space S goes from the bottom to the top. It further includes an extension 120 formed to gradually increase the cross-sectional area of 1 ).
  • the reason why the expansion part 120 has such a shape is to allow the opening of the upper part to be more expanded so that the bodily fluid sample can be more easily injected into the sample storage space S 1 .
  • a cover coupling portion 121 may be formed at an upper end of the extended portion 120, and the cover coupling portion 121 selectively shields the upper portion of the extended portion 120 so that the sample storage space S 1 )
  • a first shielding cover 400 for sealing may be coupled.
  • a coupling space 410 for coupling with the cover coupling part 121 is formed inside the first shielding cover 400.
  • the reagent storage unit 200 is formed to be inserted into the hollow open lower portion, that is, the lower side of the insertion space (S 2 ), the reagent storage space (S 3 ) in which the storage reagent is accommodated and the upper portion is opened
  • the reagent receiving portion 210 is formed, and a shielding member 230 for shielding the opened upper portion of the reagent receiving portion 210.
  • the bodily fluid sample accommodated in the sample storage space S 1 can be stored in a state separated from the storage reagent. .
  • the sample collection unit 100 is a connection portion including an extension region 132 extending a predetermined length from the lower end of the sample collection unit 110 to extend the length of the insertion space (S 2 ) Further comprising (130), wherein the reagent storage unit 200 is connected to the reagent receiving portion 210 so as to surround a portion of the lower portion of the reagent receiving portion 210, and between the reagent receiving portion 210 It has a shape that further includes a coupling portion 220 forming a clearance space in which the connection portion 130 is inserted.
  • the reagent receiving part 210 is inserted into the connection part 130 and accommodated in the insertion space S 2 , and the coupling part 220 is the connection part 130 It has a shape located outside of the connection portion 130 is sandwiched between the reagent receiving portion 210 and the coupling portion 220.
  • connection part 130 includes a first hook 134 protruding outward from the lower end of the extension region 132, and the coupling part 220 is engaged with the first hook 134. Including a second hook 221 protruding inward so that the reagent storage unit 200 is separated from the sample collection unit 100 in a state that the coupling part 220 is coupled to the connection part 130 Can be prevented.
  • the above-described breaking module 150 when the reagent receiving portion 210 is inserted in the insertion space (S 2 ) to a predetermined depth or more, a shielding member sealing the reagent receiving space (S 3 ) ( 230).
  • the shielding member 230 does not contact the breaking module 150
  • the shielding member 230 is inserted into the fracture module 150. As it touches and breaks, the bodily fluid sample accommodated in the sample storage space S 1 flows to the reagent storage space S 3 and is mixed with the storage reagent.
  • the extension area 132 of the extension part 130 may be formed to have a length corresponding to the stroke distance of the reagent storage unit 200.
  • the maximum insertion depth of the reagent receiving portion 210 is limited as it is selectively coupled to the extended region 132 and inserted between the sample collection unit 110 and the coupling unit 220 It may further include a stopper unit 300.
  • the reagent storage unit 200 is placed at a certain position so that the shielding member 230 is provided at a position not contacting the breaking module 150. It is fixed, and when the stopper unit 300 is separated from the extension area 132, there is a margin in the extension area 132 so that the reagent receiving unit 210 can be inserted deeper into the insertion space S2. By providing a length, the shielding member 230 can be broken.
  • the stopper unit 300 includes a stopper part 310 having an insertion space 311 with one side open inside so that it can be fitted in a form surrounding the extended area 132, and the stopper part 310 ) And a protruding grip part 320 so that the user can grip.
  • the shape of the stopper unit 300 may be implemented in various forms other than this embodiment.
  • the shielding member 230 may be formed of a soft film.
  • the material of the shielding member 230 is made of polyethylene terephthalate, polybutylene terephthalate, nylon, polyethylene (PE), polypropylene (PP), polyvinyl chloride, polyimide, polysulfone, or a combination thereof.
  • a polymer film selected from the group may be applied.
  • the shielding member 230 may include a cellulose film, and may also include a metal film selected from the group consisting of aluminum, copper, stainless steel, and alloys thereof, but is not limited thereto.
  • the shielding member 230 the reagent receiving portion in the form of at least one of a PTP (Press Through Pack) packaging method, LLDP (Linear Low Density Polyethylene) film form, or powder form PE (Polyethylene) film form ( 210) may be bonded around the upper end, and in this case, the shielding member 230 may further include an aluminum component.
  • PTP Pressure Through Pack
  • LLDP Linear Low Density Polyethylene
  • PE Polyethylene film form
  • breaking module 150 will be described in more detail.
  • the breaking module 150 includes a breaking member 153 having at least a portion protruding toward the insertion space S 2 so as to break the shield member 230, and the breaking member 153.
  • a fixing member 151 for fixing in the hollow, and the shielding member connected to the lower portion of the fixing member 151 and provided on the inside of the breaking member 153 and broken by the breaking member 153 It includes a fracture auxiliary member 155 that pushes the fracture region of 230 downward.
  • the breaking member 153 is formed in a ring shape spaced apart from the inner circumferential surface of the sample collection unit 110 by a predetermined distance, and the length protruding toward the insertion space (S 2 ) from one side to the other is increased. It has a shape that is formed to increase gradually.
  • the fixing member 151 the first support bar (151a) provided in a form crossing the hollow of the sample collection unit 110, and the inside of the hollow so as to cross the first support bar (151a). It includes a second support bar (151b) that is provided in a transverse form.
  • the shape of the breaking module 150 can also be implemented in various forms other than the present embodiment.
  • FIG. 9 is a view showing a state of a liquid biopsy collection device according to a second embodiment of the present invention.
  • the sample collection unit 100 includes only the sample collection unit 110 and the extension unit 130, and the expansion unit 120 of the first embodiment is omitted. Accordingly, the present embodiment can improve portability by further reducing the volume of the entire device.
  • a second shielding cover provided to seal the sample storage space S 1 by selectively shielding the upper portion of the sample collection unit 110 corresponding to the diameter of the sample collection unit 110 It may further include 500.
  • FIG. 10 is a view showing the appearance of a liquid biopsy collection device according to a third embodiment of the present invention.
  • the sample collection unit 100 has a form including all of the sample collection unit 110, the expansion unit 120, and the extension unit 130, but the sample The collection unit 110 and the expansion unit 120 are formed to be selectively coupled and separated from each other.
  • a body coupling part 122 coupled to the sample collection part 110 may be further included at a lower end of the expansion part 120.
  • the expansion unit 120 in the process of collecting bodily fluid samples, is coupled to the sample collection unit 110 to facilitate collection of bodily fluid samples, and after the collection process is completed, the expansion unit 120 ) Can be separated from the sample collection unit 110 to reduce the volume of the entire device.
  • first shielding cover 400 may be selectively coupled to the expansion unit 120
  • second shielding cover 500 may be selectively coupled to the sample collection unit 110. There will be.
  • FIG. 11 is a view showing a state of a liquid biopsy collecting device according to a fourth embodiment of the present invention.
  • the depth at which the reagent receiving part 210 is inserted into the insertion space S 2 is precisely controlled as the sample collection unit 100 and the reagent storage unit 200 are rotated relative to each other. You will have the possible advantages.
  • the present invention relates to a liquid biopsy collection device for diagnosing physiological changes or disease onset of a test subject, and in more detail, a sample of bodily fluid is collected from a subject to be tested and conveniently mixed and stored with a storage reagent at a desired time. It relates to a liquid biopsy collection device that enables this.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne un dispositif de collecte pour une biopsie liquide, comprenant : une unité de collecte d'échantillon comprenant une partie collecte d'échantillon qui a une partie creuse formée à l'intérieur de celle-ci avec des parties supérieure et inférieure ouvertes et qui permet à un échantillon de liquide corporel d'une personne examinée d'être introduit dans le côté supérieur ouvert de la partie creuse ; et une unité de stockage de réactif comprenant une partie réception de réactif qui est formée de façon à pouvoir être insérée dans le côté inférieur ouvert de la partie creuse et a un espace réception de réactif pour recevoir un réactif de conservation à l'intérieur de celle-ci et ayant une partie supérieure ouverte, et un élément de protection qui protège la partie supérieure ouverte de la partie réception de réactif, l'unité de collecte d'échantillon comprenant en outre un module de rupture disposé dans une position prédéterminée de la partie creuse pour diviser la partie creuse en un espace de stockage d'échantillon dans lequel l'échantillon de liquide corporel est stocké et un espace d'insertion dans lequel la partie réception de réactif est insérée, et rompre l'élément de protection lorsque la partie réception de réactif est insérée dans l'espace d'insertion par une profondeur prédéfinie ou plus profonde.
PCT/KR2020/008295 2019-06-25 2020-06-25 Dispositif de collecte pour biopsie liquide WO2020262991A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20190075924 2019-06-25
KR10-2019-0075924 2019-06-25

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WO2020262991A1 true WO2020262991A1 (fr) 2020-12-30

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5429855B2 (fr) * 1972-01-19 1979-09-26
US4786471A (en) * 1983-10-21 1988-11-22 Baxter Travenol Laboratories, Inc. Heterogeneous immunoassay method and assembly
JPH0646828A (ja) * 1992-06-01 1994-02-22 Eastman Kodak Co 格納状態で検出するために液体を介して標的担持固体を移動させるための装置及び方法
KR20050008693A (ko) * 2002-04-22 2005-01-21 호쿠토카가쿠산교 카부시키사이샤 유전자 검출용구, 검출방법 및 검출용 키트
JP4423351B2 (ja) * 2002-07-03 2010-03-03 セロメトリックス インコーポレイテッド 生物学的サンプルを濾過する装置及び方法

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170246625A1 (en) * 2011-12-21 2017-08-31 Pathway Genomics Corporation Genetic sample collection systems
CN107106146B (zh) * 2014-11-17 2019-11-08 踪迹责任有限公司 用于收集和保存活组织检查样本的容器
CN108113712B (zh) * 2016-11-30 2024-05-31 厦门致善生物科技股份有限公司 体液收集器和体液收集方法
KR101880052B1 (ko) 2017-09-18 2018-07-20 김호동 검체 보관 용기

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5429855B2 (fr) * 1972-01-19 1979-09-26
US4786471A (en) * 1983-10-21 1988-11-22 Baxter Travenol Laboratories, Inc. Heterogeneous immunoassay method and assembly
JPH0646828A (ja) * 1992-06-01 1994-02-22 Eastman Kodak Co 格納状態で検出するために液体を介して標的担持固体を移動させるための装置及び方法
KR20050008693A (ko) * 2002-04-22 2005-01-21 호쿠토카가쿠산교 카부시키사이샤 유전자 검출용구, 검출방법 및 검출용 키트
JP4423351B2 (ja) * 2002-07-03 2010-03-03 セロメトリックス インコーポレイテッド 生物学的サンプルを濾過する装置及び方法

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KR20210000686A (ko) 2021-01-05

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