WO2023153465A1 - Récipient pour collecter un échantillon biologique liquide et son procédé de cryoconservation - Google Patents

Récipient pour collecter un échantillon biologique liquide et son procédé de cryoconservation Download PDF

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Publication number
WO2023153465A1
WO2023153465A1 PCT/JP2023/004291 JP2023004291W WO2023153465A1 WO 2023153465 A1 WO2023153465 A1 WO 2023153465A1 JP 2023004291 W JP2023004291 W JP 2023004291W WO 2023153465 A1 WO2023153465 A1 WO 2023153465A1
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WO
WIPO (PCT)
Prior art keywords
biological sample
liquid biological
main body
recovery member
recovery
Prior art date
Application number
PCT/JP2023/004291
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English (en)
Japanese (ja)
Inventor
智 兼子
由以 萩原
直朗 安村
知樹 津村
Original Assignee
ニプロ株式会社
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Filing date
Publication date
Application filed by ニプロ株式会社 filed Critical ニプロ株式会社
Publication of WO2023153465A1 publication Critical patent/WO2023153465A1/fr

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    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N1/00—Preservation of bodies of humans or animals, or parts thereof
    • A01N1/02—Preservation of living parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues

Definitions

  • the present invention relates to a collection container for centrifuging a liquid biological sample and a cryopreservation method for centrifuging and freezing a liquid biological sample.
  • the sperm concentration container described in Patent Document 1 includes a substantially cylindrical body portion having an open end, a small diameter portion having a bottom portion at the tip, and a diameter toward the small diameter portion connecting the body portion and the small diameter portion. and a middle portion where the tapering is tapered.
  • a fragile portion having an outer diameter smaller than the outer diameter of the small-diameter portion is formed on the outer peripheral surface of the small-diameter portion.
  • the operator collects the concentrated sperm by breaking off the small-diameter portion where the sperm settles at the fragile portion.
  • the concentrated sperm is transferred from the small-diameter part to another container. For this reason, the task of cryopreserving concentrated sperm is troublesome.
  • the concentrated sperm is transferred from the small-diameter portion to another container, the sperm are likely to be lost, or foreign substances such as germs are likely to be mixed into the other container.
  • the present invention has been made in view of the circumstances described above, and its purpose is to provide a collection container for a liquid biological sample that can easily collect the sedimented portion after centrifuging the liquid biological sample.
  • Another object of the present invention is to provide a method for easily cryopreserving a liquid biological sample by centrifuging it.
  • a collection container for a liquid biological sample according to the present invention is connectable to a tubular main body with first and second ends opened, and a state in which liquid flows through the first end, and the liquid is a retrieval member having a receivable interior space.
  • the collection member having an internal space capable of containing a liquid can be connected to the first end of the main body in a state in which the liquid flows.
  • the recovery member in which a part of the biological sample has sedimented can be easily removed from the main body. Therefore, the liquid biological sample is less likely to scatter from the recovery member than when the recovery member is folded off from the main body. Therefore, the operator can easily collect the sedimented portion after centrifuging the liquid biological sample.
  • the thickness of the recovery member may be within the range of 0.3 mm to 0.7 mm.
  • the thickness of the recovery member is within 0.7 mm, heat is easily transferred from the outside of the recovery member to the internal space. Therefore, when freezing the liquid biological sample collected in the collecting member removed from the main body, the operator can easily freeze the liquid biological sample. Since the collecting member has a thickness of 0.3 mm or more, the durability of the collecting member is easily ensured.
  • the recovery member may be a molded product of a synthetic resin composition containing impact-resistant polystyrene as a main component.
  • the impact-resistant polystyrene may contain a styrene/butadiene copolymer.
  • Flexibility can be suitably imparted to the recovery member.
  • the recovery member may have a total light transmittance of 80% or more.
  • the recovery member may have a gripping portion having two planes separated from each other.
  • the interior space may be located between two said planes.
  • the operator can grip the recovery member by pinching the two flat surfaces of the gripping portion separated from each other with the fingertips, so that the recovery member can be easily gripped. Since the internal space of the collecting member is positioned between the two planes, the internal space of the collecting member is less likely to be hidden by the fingertips when the operator pinches the two planes with the fingertips. Therefore, the worker can easily visually recognize the internal space of the collecting member when holding the collecting member.
  • the collecting member may have a plate-like piece located on the tip side of the two planes and protruding from the outer peripheral surface.
  • the plate-like piece may protrude along a direction intersecting the two planes.
  • the plate-shaped pieces protrude toward the fingertips. is hard to get in the way. Therefore, it is possible to improve the durability of the collecting member while ensuring the visibility of the internal space of the collecting member.
  • a cryopreservation method for a liquid biological sample according to the present invention is a method for cryopreserving a liquid biological sample using a collection container in which a main body and a collection member are detachable, wherein the main body and the collection member are connected.
  • a separation step of enclosing a liquid biological sample in the recovery container in a closed state and centrifuging; a detachment step of removing the recovery member from the main body; and a freezing step of sealing and freezing the recovery member. include.
  • the operator removes from the main body the recovery member in which a portion of the liquid biological sample has settled after centrifugation of the liquid biological sample, and then seals and freezes the recovery member.
  • the freezing process can be easily performed as compared with the case of transferring from the collecting member to another container and freezing. Since the liquid biological sample is not transferred from the collection member to another container in the freezing step, the loss of the liquid biological sample is suppressed and foreign matter such as germs is less likely to enter the collection member.
  • the recovery member may be sealed by fitting a lid to the opening of the recovery member.
  • the liquid biological sample may be human semen.
  • the recovery member may further include a cap seal having a substrate and a gel adhesive layer laminated on the substrate.
  • the cap seal may seal the opening of the second end by bonding the adhesive layer to the second end of the main body.
  • the substrate suppresses deformation of the cap seal when the adhesive layer is adhered to the second end of the main body. Therefore, when the adhesive layer is adhered to the second end of the main body, the pressure inside the collection container is less likely to change. Therefore, when the adhesive layer is adhered to the second end of the body, the liquid biological sample contained in the recovery member is prevented from being sucked toward the body due to negative pressure in the recovery container. Conversely, the increased pressure in the collection container suppresses leakage of the liquid biological sample from the first end of the main body when the collection member is removed from the main body.
  • liquid biological sample collection container of the present invention it is possible to easily collect the sedimented portion after centrifuging the liquid biological sample.
  • cryopreservation method for a liquid biological sample of the present invention a liquid biological sample can be centrifuged and easily cryopreserved.
  • FIG. 1 is an exploded perspective view of a collection container 1 according to an embodiment of the invention.
  • FIG. 2 is a longitudinal sectional view of the collection container 1 according to the embodiment of the invention.
  • FIG. 3 is a cross-sectional view of the main body 2 cut along a plane including the center line C of the collection container 1 according to the embodiment of the present invention.
  • FIG. 4 is an enlarged cross-sectional view of the periphery including the female screw portion 2D of FIG.
  • FIG. 5 is a side view of the recovery member 3 of the recovery container 1 according to the embodiment of the present invention.
  • FIG. 6 is a cross-sectional view taken along line VI-VI of FIG. FIG.
  • FIG. 7 is a cross-sectional view showing a state in which the lid 31 for depressurizing the main body is attached to the proximal end 23 of the main body 2.
  • FIG. 8 is a perspective view showing a state in which the lid 41 is press-fitted into the second opening 12 of the base end 72 of the recovery member 3.
  • FIG. 9 is a perspective view of a modification of the collection member 3 of the collection container 1 according to the embodiment of the present invention.
  • FIG. 10 is a side view of the recovery member 3 of the modified example of FIG.
  • FIG. 11 is a side view of another modification of the collection member 3 of the collection container 1 according to the embodiment of the present invention.
  • FIG. 12 is a side view of another modification of the collection member 3 of the collection container 1 according to the embodiment of the present invention.
  • FIG. 13 is a side view of another modification of the collection member 3 of the collection container 1 according to the embodiment of the present invention.
  • 14 is a cross-sectional view showing a state in which the cap seal 51 is attached to the proximal end 23 of the main body 2.
  • FIG. 15 is a cross-sectional view of the cap seal 51.
  • a collection container 1 for a liquid biological sample comprises a main body 2 having a tubular shape with both ends opened, and a collection member 3 having a tubular shape connectable to the main body 2 . , and a lid member 4 having a cylindrical shape that closes the opening of the main body 2 .
  • the direction along the center line C of the collection container 1 is defined as the longitudinal direction.
  • the main body 2 has a cylindrical shape longer than the recovery member 3 in the direction along the center line C.
  • the main body 2 is made of a resin material.
  • the material of the main body 2 is not particularly limited as long as it is a resin material having durability that can withstand centrifugal separation in the separation step described later.
  • the material of the main body 2 can include hard plastics such as polypropylene and polycarbonate.
  • the main body 2 has a body portion 2A, a small diameter portion 2B, a first taper portion 2C (an example of a taper portion), and a female screw portion 2D.
  • the body portion 2A is formed such that the inner diameter slightly decreases toward the tip 22 (an example of the first end), which is one of both ends of the body 2.
  • the body portion 2A may be formed so that the inner diameter is equal in the longitudinal direction.
  • the narrow diameter portion 2B is a portion that is thinner than the body portion 2A. That is, the inner diameter and outer diameter of the small diameter portion 2B are smaller than the inner diameter and outer diameter of the body portion 2A, respectively.
  • the small-diameter portion 2B is formed such that the inner diameter slightly decreases toward the tip 22 .
  • the small diameter portion 2B may be formed so that the inner diameter is equal in the longitudinal direction.
  • the first tapered portion 2C is a portion that connects the body portion 2A and the small diameter portion 2B, and is formed such that the inner diameter gradually tapers toward the tip 22.
  • the first tapered portion 2C may be curved inward from the body portion 2A at a substantially right angle to be connected to the small-diameter portion 2B, or may be formed as a step.
  • the female threaded portion 2D is arranged radially outward of the small diameter portion 2B.
  • the female screw portion 2D has a tubular shape extending along the longitudinal direction.
  • the center of the female screw portion 2D coincides with the centerline C.
  • the inner diameter of the female threaded portion 2D is larger than the outer diameter of the small diameter portion 2B.
  • the tip of the female screw portion 2D is open.
  • the proximal end opposite to the distal end of the female threaded portion 2D is closed.
  • the proximal end of the female screw portion 2D is connected to the proximal end of the small diameter portion 2B.
  • a tip 22 of the small diameter portion 2B protrudes from the tip of the female screw portion 2D.
  • a female thread 5 is formed on the inner peripheral surface of the female threaded portion 2D.
  • a reinforcing rib 6 extending radially outward from the outer peripheral surface of the first tapered portion 2C is connected to the base end surface of the female screw portion 2D (see FIGS. 1 and 3).
  • four reinforcing ribs 6 are arranged at regular intervals in the circumferential direction.
  • the recovery member 3 is configured to be connectable to the tip 22 of the main body 2 in a liquid-flowing state (see FIG. 2).
  • the recovery member 3 is a molded product of a synthetic resin composition containing impact-resistant polystyrene as a main component.
  • High impact polystyrene includes a styrene-butadiene copolymer.
  • the flexibility of the high-impact polystyrene improves, but the transparency of the high-impact polystyrene decreases.
  • the smaller the content of the styrene/butadiene copolymer in the high-impact polystyrene the lower the flexibility of the high-impact polystyrene and the higher the transparency of the high-impact polystyrene.
  • the recovery member 3 it is preferable to adjust the content of the styrene/butadiene copolymer in the impact-resistant polystyrene so that the total light transmittance of the recovery member 3 is 80% or more. More preferably, the total light transmittance of the recovery member 3 is 87% or more, and particularly preferably 89% or more. If the total light transmittance of the recovery member 3 is 80% or more, the recovery member 3 is highly transparent, so that the operator can easily visually recognize the human sperm recovered by the recovery member 3 in the later-described detachment step. . As shown in FIGS. 2, 5, and 6, the recovery member 3 has a housing portion 7, a grip portion 8, a plate-like piece 9, and male threads 10. As shown in FIGS.
  • the housing portion 7 has a cylindrical shape with a closed distal end 71 and an open proximal end 72 opposite to the distal end.
  • the containing portion 7 has an internal space 7A capable of containing liquid.
  • the accommodating portion 7 is formed in a tapered shape in which the inner diameter and the outer diameter are slightly reduced toward the tip.
  • the accommodating portion 7 has a large diameter portion 7B, a small diameter portion 7C, and a second tapered portion 7D.
  • the inner diameter of the large diameter portion 7B is equal to or slightly larger than the outer diameter of the small diameter portion 2B.
  • the outer diameter of the large diameter portion 7B is slightly smaller than the inner diameter of the internal thread portion 2D.
  • the small-diameter portion 7C is positioned closer to the distal end than the large-diameter portion 7B in the housing portion 7 .
  • the inner diameter of the small diameter portion 7C is smaller than the inner diameter of the large diameter portion 7B.
  • the thickness between the outer peripheral surface and the inner peripheral surface of the small diameter portion 7C is preferably within the range of 0.3 mm to 0.7 mm.
  • the thickness of the small diameter portion 7C is within the range of 0.3 mm to 0.6 mm, and particularly preferably within the range of 0.45 mm to 0.55 mm. If the thickness of the small-diameter portion 7C is 0.7 mm or less, heat is easily transferred from the outer peripheral surface to the inner peripheral surface of the small-diameter portion 7C. If the thickness of the small-diameter portion 7C is 0.3 mm or more, it is easy to secure the durability of the small-diameter portion 7C during centrifugal separation in the later-described separation step.
  • the second tapered portion 7D connects the large diameter portion 7B and the small diameter portion 7C.
  • the gripping portion 8 is formed on the outer peripheral surface side of the accommodating portion 7 .
  • the grip portion 8 is formed in a pair of flat plate shapes having two flat surfaces 8A separated from each other.
  • the two planes 8A are parallel to the centerline C.
  • the two planes 8A face each other in parallel with the center line C interposed therebetween.
  • the grip portion 8 extends from the proximal end of the second tapered portion 7D to a substantially intermediate position in the longitudinal direction of the small diameter portion 7C.
  • An internal space 7A of the housing portion 7 is located between the two planes 8A.
  • the plate-shaped piece 9 protrudes radially outward from the small diameter portion 7C and connects the small diameter portion 7C and the grip portion 8 .
  • the plate-like piece 9 is located on the tip side of the two planes 8A.
  • the plate-like piece 9 protrudes along the direction intersecting the two planes 8A.
  • the plate-like piece 9 protrudes along the direction perpendicular to the two planes 8A (see FIG. 5).
  • the plate-like piece 9 extends from a position adjacent to the tip side of each of the two planes 8A to the tip 71 of the small diameter portion 7C.
  • the male thread 10 is formed on the outer peripheral surface of the large diameter portion 7B of the accommodating portion 7.
  • the male screw 10 is positioned on the proximal end side of the large diameter portion 7B.
  • the male thread 10 can be screwed into the female thread 5 of the female threaded portion 2D.
  • the male screw 10 protrudes radially outward from the outer peripheral surface of the large diameter portion 7B.
  • the male screw 10 extends along the circumferential direction of the outer peripheral surface of the large diameter portion 7B.
  • two male threads 10 are spaced apart at a position of 180 degrees with respect to the center line C. As shown in FIG.
  • the male thread 10 is screwed into the female thread 5 of the female thread portion 2D in a state where the small diameter portion 2B of the main body 2 is inserted into the large diameter portion 7B of the accommodating portion 7 (see FIG. 2).
  • the recovery member 3 is detachably connected to the main body 2 .
  • liquid can flow between the internal space of the main body 2 and the internal space 7A of the recovery member 3 through the distal end 22 of the small diameter portion 2B.
  • the lid member 4 is a member that closes the first opening 11 at the proximal end 23 (an example of the second end) opposite to the distal end of the main body 2 .
  • the lid member 4 is not particularly limited as long as it closes the first opening 11 of the main body 2, and may be a general-purpose product or a dedicated product combined with the collection container 1.
  • the lid member 4 is formed so as to be press-fitted into the first opening 11 .
  • the lid member 4 has a press-fit portion 4A, a covering portion 4B, and a handle 4C.
  • the press-fit portion 4A has a cylindrical shape with an open tip and a closed base end.
  • the press-fitting portion 4A is formed so as to be press-fittable inside the main body 2 through the first opening 11 .
  • the covering portion 4 ⁇ /b>B has a tubular shape with an inner diameter slightly larger than the outer diameter of the proximal end 23 of the main body 2 .
  • the proximal end of the covering portion 4B is connected to the proximal end of the press-fitting portion 4A.
  • the covering portion 4B covers the outer peripheral surface of the main body 2 on the proximal end 23 side in a state in which the press-fitting portion 4A is press-fitted inside the main body 2 .
  • the handle 4C protrudes radially outward from the outer peripheral surface of the covering portion 4B.
  • a material for the lid member 4 is not particularly limited.
  • the material of the lid member 4 can include hard plastics such as polypropylene and polycarbonate.
  • a cryopreservation method for a liquid biological sample using the recovery container 1 configured as described above will be described.
  • human semen is used as the liquid biological sample.
  • a separation step, a detachment step, and a freezing step are performed in order.
  • the operator first puts human semen, density gradient liquid for centrifugation, etc. into the recovery container 1 in which the main body 2 and the recovery member 3 are connected. Next, the operator closes the first opening 11 at the proximal end of the main body 2 with the lid member 4 .
  • the operator attaches the collection container 1 to the centrifuge and centrifuges the semen enclosed in the collection container 1.
  • centrifugation spermatozoa are sedimented toward the collection member 3 from the semen in the density gradient liquid, and the concentrated human spermatozoa are stored in the storage portion 7 of the collection member 3 .
  • the operator removes the collection member 3 from the main body 2 and collects the concentrated human semen. Specifically, the operator first removes the lid member 4 from the main body 2, and attaches a main body decompression lid 31 made of rubber to the proximal end 23 of the main body 2, as shown in FIG.
  • the body decompression lid 31 has a cylindrical shape with a closed proximal end.
  • the lid 31 for depressurizing the main body has a cylindrical fitting portion 31A that fits with the outer peripheral surface of the base end 23 side of the main body 2, and a cylindrical bag shape having an inner diameter smaller than the outer diameter of the base end 23 of the main body 2. and a portion 31B.
  • the bag-like portion 31B is connected to the proximal end of the fitting portion 31A.
  • the operator presses the fitting portion 31A on the outer peripheral surface of the proximal end 23 side of the main body 2 while denting the bag-shaped portion 31B with a fingertip.
  • a negative pressure state a state where the pressure is lower than the atmospheric pressure.
  • the lid 31 for depressurizing the main body is not particularly limited as long as it can make the space generated in the collection container 1 after the semen and the density gradient liquid are put into a negative pressure state, and it may be a general-purpose product. It may be a dedicated product that is set with the collection container 1 .
  • the operator pinches the two flat surfaces 8A of the grasping portion 8 of the recovery member 3 with the fingertips and rotates the recovery member 3 relative to the main body 2 .
  • the female thread 5 of the female threaded portion 2 ⁇ /b>D of the main body 2 and the male thread 10 of the recovery member 3 are disengaged, and the recovery member 3 is removed from the main body 2 .
  • the space on the body 2 side of the collection container 1 is decompressed, even if the collection member 3 is removed, the semen or the density gradient liquid is less likely to flow out from the tip 22 of the small diameter portion 2B of the body 2.
  • the operator first seals the recovery member 3 by fitting the lid 41 into the second opening 12 of the proximal end 72 of the recovery member 3, as shown in FIG.
  • the lid 41 is not particularly limited as long as it closes the second opening 12 of the collection member 3, and may be a general-purpose product or a dedicated product combined with the collection container 1. .
  • the lid 41 has a shape that can be press-fitted into the second opening 12 .
  • the operator cools the sealed recovery member 3 with a deep freezer, liquid nitrogen, or the like to freeze the contained concentrated spermatozoa.
  • the recovery member 3 with the frozen concentrated sperm is stored in a freezer or the like at an appropriate temperature.
  • the collection member 3 having the internal space 7A capable of containing the liquid can be connected to the tip 22 of the main body 2 in a liquid-flowing state.
  • the recovery member 3 in which the human sperm is sedimented can be easily removed from the main body 2. - ⁇ Therefore, when the operator removes the recovery member 3 from the main body 2 , human spermatozoa are less likely to scatter from the recovery member 3 . Therefore, an operator can easily collect sedimented sperm after centrifuging human semen.
  • the thickness between the outer peripheral surface and the inner peripheral surface of the small diameter portion 7C of the storage portion 7 in the recovery member 3 is within the range of 0.3 mm to 0.7 mm. heat is easily transferred to the inner peripheral surface. Therefore, the operator can easily freeze the human sperm collected by the collecting member 3 in the freezing process. Since the thickness between the inner peripheral surface and the outer peripheral surface of the small diameter portion 7C is 0.3 mm or more, it is easy to secure the durability of the small diameter portion 7C during centrifugal separation in the separation step.
  • the collection member 3 is a molded product of a synthetic resin composition whose main component is impact-resistant polystyrene, so the collection member 3 is highly flexible. Therefore, when the recovery member 3 is connected to the main body 2 , the recovery member 3 is likely to come into close contact with the main body 2 .
  • the impact-resistant polystyrene which is the main component of the collection member 3 contains a styrene-butadiene copolymer, so the flexibility of the collection member 3 can be easily improved.
  • the transparency of the collection member 3 is high. Therefore, the operator can easily visually recognize the human sperm collected by the collecting member 3 .
  • the worker can grasp the collection member 3 by pinching the two flat surfaces 8A of the grasping portion 8 with their fingertips, so that the collection member 3 can be easily grasped. Since the internal space 7A of the housing portion 7 is positioned between the two planes 8A, the internal space 7A of the housing portion 7 is less likely to be hidden by the fingertips when the operator holds the two planes 8A with the fingertips. Therefore, the operator can easily visually recognize the human sperm within the internal space 7 ⁇ /b>A of the container 7 when holding the collection member 3 .
  • the plate-like piece 9 projecting from the outer peripheral surface of the small-diameter portion 7C of the housing portion 7 projects in a direction orthogonal to the two planes 8A, so that the operator can grasp the two planes 8A with their fingertips. At this time, the plate-like piece 9 protrudes toward the fingertip. Therefore, when the operator picks up the two flat surfaces 8A with his fingertips and visually recognizes the human spermatozoa in the internal space 7A of the housing portion 7, the plate-like piece 9 is less likely to be an obstacle. Therefore, the durability of the small-diameter portion 7C of the housing portion 7 can be improved while ensuring the visibility of the internal space 7A of the housing portion 7 .
  • the operator freezes the recovery member 3 in which the human sperm is sealed in the freezing step, so the human sperm is transferred from the recovery member 3 to another container and frozen.
  • the freezing process can be easily performed as compared with the case. Since the human semen is not transferred from the recovery member 3 to another container in the freezing process, the loss of the human semen is suppressed and the recovery member 3 is less likely to be contaminated with foreign substances such as germs.
  • the operator seals the recovery member 3 by fitting the lid 41 into the second opening 12 of the proximal end 72 of the recovery member 3 in the freezing step. Easy to stop.
  • the grasping portion 8 of the collection member 3 extends from the proximal end of the second tapered portion 7D to approximately the middle position in the longitudinal direction of the small diameter portion 7C. It may extend from the proximal end of the second tapered portion 7D to the distal end 71 of the small diameter portion 7C.
  • a plurality of convex portions 13 may be formed on the two planes 8A of the grip portion 8. FIG. As a result, the two planes 8A are relatively large and can be easily grasped by the operator's fingertips.
  • the plate-like piece 9 is formed so as to connect the outer peripheral surface of the small-diameter portion 2B and the inner surface of the grip portion 8 .
  • the plate-like piece 9 extends from the proximal end of the small diameter portion 2B to the distal end 71 .
  • the gripping property of the grip portion 8 can be improved while ensuring the durability of the collecting member 3 .
  • the collection member 3 can stand alone in a state in which one end of the gripping portion 8 is in contact with the mounting surface of the desk or the like without bringing the second opening 12 close to the desk or the like, the recovery member 3 can stand on its own when the work is interrupted. Contamination risk can be reduced.
  • the gripping portion 8 extends from the proximal end of the second tapered portion 7D to the distal end 71 of the small diameter portion 7C, the plate-like piece 9 may be omitted as shown in FIG.
  • the grasping portion 8 of the collection member 3 is formed on the outer peripheral surface of the storage portion 7, but may be omitted as shown in FIG.
  • the plate-like piece 9 may extend to the proximal end of the second tapered portion 7D.
  • a plurality of reinforcing pieces 14 may be formed at intervals in the circumferential direction on the outer peripheral surface of the small diameter portion 7C. Each reinforcing piece 14 protrudes radially from the outer peripheral surface of the small diameter portion 7C, and the projecting end surface of the reinforcing piece 14 is flush with the outer peripheral surface of the large diameter portion 7B.
  • the plurality of reinforcing pieces 14 extend from substantially the middle position in the longitudinal direction of the small diameter portion 2B to the base end of the second tapered portion 7D.
  • the internal space 7A can be visually recognized between the plurality of reinforcing pieces 14. As shown in FIG.
  • the worker since the worker holds the reinforcing piece 14 so as to sandwich it, the worker does not directly touch the outer peripheral surface of the small diameter portion 7C. Note that the reinforcing piece 14 may be omitted as shown in FIG.
  • the space inside the collection container 1 was decompressed by attaching a rubber lid 31 for main body decompression to the main body 2.
  • a rubber lid 31 for main body decompression since the degree of pressure reduction by the cover 31 for depressurizing the main body depends on the operator, when the cover 31 for depressurizing the main body is attached to the main body 2, there is a possibility that the negative pressure inside the collection container 1 becomes too strong. Therefore, the sperm contained in the collecting member 3 is sucked toward the main body 2 by the negative pressure in the collecting container 1, which may make it difficult to efficiently collect the sperm by the collecting member 3. There is a problem.
  • a cap seal 51 may be attached to the proximal end 23 of the main body 2 as shown in FIG.
  • the cap seal 51 is flat.
  • the front and back surfaces of the cap seal 51 are circular with a diameter larger than the outer diameter of the proximal end 23 of the main body 2 .
  • the front and back surfaces of the cap seal 51 are not limited to circular shapes as long as the space inside the collection container 1 can be airtight.
  • the cap seal 51 may be square.
  • the thickness of the cap seal 51 is equal to or greater than the thickness of the main body 2 .
  • the cap seal 51 has a substrate 52, an adhesive layer 53, and a release layer 54, as shown in FIG.
  • the substrate 52 is flat. A front surface and a rear surface 52A of the substrate 52 are circular.
  • the substrate 52 preferably has no air permeability and good adhesion to the adhesive layer 53 .
  • the substrate 52 is not deformed by the negative pressure generated in the space of the main body 2 when the recovery member 3 is removed from the main body 2 in the detachment process after the cap seal 51 is attached to the proximal end 23 of the main body 2. It is preferable to have a degree of strength.
  • the negative pressure generated in the space of the main body 2 is a slight negative pressure of 628 Pa, assuming that 10 g of the liquid biological sample is enclosed in the collection container 1 and the inner diameter of the main body 2 is 14.1 mm.
  • the substrate 52 is made of a material having sufficient strength not to be deformed against a negative pressure of 628 Pa.
  • substrate 52 may be formed of plastic or metal.
  • plastics include polyethylene terephthalate (PET), polystyrene (PS), polypropylene (PP), and polyethylene (PE).
  • metals include copper and iron.
  • a metal alloyed to increase strength may be used as the material of the substrate 52.
  • alloys include aluminum alloys.
  • the thickness of the substrate 52 is, for example, 0.25 mm or more. Preferably, the thickness of substrate 52 is 0.5 mm.
  • the adhesive layer 53 is adhered to the back surface 52A of the substrate 52.
  • the adhesive layer 53 is flat.
  • the front surface and back surface 53A of the adhesive layer 53 are circular.
  • the diameter of adhesive layer 53 is equal to the diameter of substrate 52 .
  • the surface of the adhesive layer 53 opposite to the surface in contact with the substrate 52 (hereinafter referred to as back surface 53A) is adhered over the entire circumference of the proximal end 23 of the main body 2 .
  • the adhesive layer 53 is preferably made of a non-breathable and elastic material in order to enhance adhesion to the proximal end 23 of the main body 2 .
  • the adhesive layer 53 is preferably made of a gel-like adhesive. Examples of gel adhesives include acrylic adhesives, rubber adhesives, and urethane adhesives.
  • the thickness of the adhesive layer 53 is, for example, 1.2 mm or more. Preferably, the thickness of the adhesive layer 53 is 2.0 mm.
  • the release layer 54 is adhered to the back surface 53A of the adhesive layer 53.
  • the release layer 54 is flat.
  • the front and back surfaces of the release layer 54 are circular.
  • the diameter of the release layer 54 is larger than the diameter of the adhesive layer 53 .
  • the operator can pinch the part of the peeling layer 54 protruding from the adhesive layer 53 with fingers, so that the peeling layer 54 can be easily peeled off from the adhesive layer 53 .
  • the release layer 54 may differ from the adhesive layer 53 in shape. For example, if the adhesive layer 53 is circular, the release layer 54 may be square.
  • the worker first peels off the release layer 54 of the cap seal 51 from the back surface 53A of the adhesive layer 53.
  • the operator removes the lid member 4 from the main body 2, and presses the rear surface 53A of the adhesive layer 53 against the base end 23 of the main body 2 to bond it, as shown in FIG.
  • the substrate 52 prevents the deformation of the cap seal 51 and the extension and breakage of the adhesive layer 53 due to the pressing force when the back surface 53A of the adhesive layer 53 is pressed against the proximal end 23 of the main body 2.
  • the lid member 4 into which the press-fitting portion 4A is inserted into the first opening 11 of the main body 2 and the lid 31 for decompressing the main body are attached to the main body.
  • the pressure in the space on the main body 2 side of the collection container 1 does not increase or decrease as compared with the case where it is attached to the proximal end 23 of the collection container 1 . That is, even if the cap seal 51 is attached to the proximal end 23 of the main body 2, the pressure in the space of the recovery container 1 on the main body 2 side is only approximately equal to the atmospheric pressure. Therefore, the sperm contained in the recovery member 3 will not be sucked toward the main body 2 due to excessive negative pressure in the recovery container 1 .
  • the operator pinches the two flat surfaces 8A of the grasping portion 8 of the recovery member 3 with the fingertips and rotates the recovery member 3 relative to the main body 2 .
  • the female thread 5 of the female threaded portion 2 ⁇ /b>D of the main body 2 and the male thread 10 of the recovery member 3 are disengaged, and the recovery member 3 is removed from the main body 2 .
  • the substrate 52 prevents the cap seal 51 from being deformed by a slight negative pressure generated in the space of the main body 2 .
  • the space in the main body 2 has a slight negative pressure and is airtightly maintained by the cap seal 51, even if the collecting member 3 is removed, the pressure in the space in the main body 2 causes the diameter of the main body 2 to decrease. It is difficult for the semen or the density gradient liquid to flow out from the tip 22 of the portion 2B.
  • the operator closed the first opening 11 of the proximal end 23 of the main body 2 with the lid member 4 to perform centrifugal separation.
  • 11 may be closed with a cap seal 51 for centrifugation.
  • the work of attaching the cap seal 51 to the main body 2 is omitted in the detachment step, so the work of cryopreserving the liquid biological sample is simplified.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • Dentistry (AREA)
  • Cell Biology (AREA)
  • Environmental Sciences (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Hematology (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

[Problème] Le problème décrit par la présente invention est de fournir un récipient pour collecter un échantillon biologique liquide qui permet une collecte facile d'une partie décantée après centrifugation de l'échantillon biologique liquide. [Solution] Un récipient 1 pour collecter un échantillon biologique liquide, comprenant : un corps cylindrique 2 ouvert au niveau d'une première extrémité 22 et d'une seconde extrémité 23 ; et un élément de collecte 3 qui peut être relié à la première extrémité 22 de façon à permettre à un liquide de s'écouler à travers celui-ci et qui a un espace interne 7A apte à loger le liquide.
PCT/JP2023/004291 2022-02-10 2023-02-09 Récipient pour collecter un échantillon biologique liquide et son procédé de cryoconservation WO2023153465A1 (fr)

Applications Claiming Priority (2)

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JP2022019219 2022-02-10
JP2022-019219 2022-02-10

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WO2023153465A1 true WO2023153465A1 (fr) 2023-08-17

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08108096A (ja) * 1994-08-17 1996-04-30 Toshiki Uchida 遠心分離用容器
JP2000070763A (ja) * 1998-09-01 2000-03-07 Toshimasa Yamamoto 分離部材と分離容器及び遠心分離方法
JP2008110272A (ja) * 2006-10-27 2008-05-15 Nipro Corp 遠心分離容器及び遠心分離方法
JP2012115829A (ja) * 2010-11-09 2012-06-21 Jms Co Ltd 分離容器および分離方法
JP2015057287A (ja) * 2014-11-25 2015-03-26 独立行政法人国立がん研究センター 遠心分離用用具
JP2018116040A (ja) * 2017-01-19 2018-07-26 東ソー株式会社 遠沈管およびその使用方法
JP2019176831A (ja) * 2018-03-30 2019-10-17 大研医器株式会社 核酸回収方法および容器

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08108096A (ja) * 1994-08-17 1996-04-30 Toshiki Uchida 遠心分離用容器
JP2000070763A (ja) * 1998-09-01 2000-03-07 Toshimasa Yamamoto 分離部材と分離容器及び遠心分離方法
JP2008110272A (ja) * 2006-10-27 2008-05-15 Nipro Corp 遠心分離容器及び遠心分離方法
JP2012115829A (ja) * 2010-11-09 2012-06-21 Jms Co Ltd 分離容器および分離方法
JP2015057287A (ja) * 2014-11-25 2015-03-26 独立行政法人国立がん研究センター 遠心分離用用具
JP2018116040A (ja) * 2017-01-19 2018-07-26 東ソー株式会社 遠沈管およびその使用方法
JP2019176831A (ja) * 2018-03-30 2019-10-17 大研医器株式会社 核酸回収方法および容器

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