WO2018003786A1 - 凍結保存容器及び凍結保存容器システム - Google Patents
凍結保存容器及び凍結保存容器システム Download PDFInfo
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- WO2018003786A1 WO2018003786A1 PCT/JP2017/023536 JP2017023536W WO2018003786A1 WO 2018003786 A1 WO2018003786 A1 WO 2018003786A1 JP 2017023536 W JP2017023536 W JP 2017023536W WO 2018003786 A1 WO2018003786 A1 WO 2018003786A1
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- WIPO (PCT)
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- space
- container
- container body
- partition wall
- cryopreservation
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Classifications
-
- 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
- A01N1/0236—Mechanical aspects
- A01N1/0263—Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
- A01N1/0268—Carriers for immersion in cryogenic fluid, both for slow-freezing and vitrification, e.g. open or closed "straws" for embryos, oocytes or semen
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
-
- 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
- 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
- A01N1/0278—Physical preservation processes
- A01N1/0284—Temperature processes, i.e. using a designated change in temperature over time
-
- 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
- A61J1/14—Details; Accessories therefor
- A61J1/1406—Septums, pierceable membranes
-
- 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
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- 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
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2093—Containers having several compartments for products to be mixed
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B51/00—Devices for, or methods of, sealing or securing package folds or closures; Devices for gathering or twisting wrappers, or necks of bags
- B65B51/10—Applying or generating heat or pressure or combinations thereof
- B65B51/22—Applying or generating heat or pressure or combinations thereof by friction or ultrasonic or high-frequency electrical means, i.e. by friction or ultrasonic or induction welding
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B7/00—Closing containers or receptacles after filling
- B65B7/02—Closing containers or receptacles deformed by, or taking-up shape, of, contents, e.g. bags, sacks
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D51/00—Closures not otherwise provided for
- B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
- B65D81/20—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
-
- 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
- A61J2200/00—General characteristics or adaptations
- A61J2200/40—Heating or cooling means; Combinations thereof
- A61J2200/44—Cooling means
Definitions
- the present invention relates to a cryopreservation container and a cryopreservation container system for cryopreserving biological samples and medicines.
- Patent Documents 1 and 2 disclose a cryopreservation container that seals an opening of a container by welding a part of the container.
- liquid nitrogen may permeate through the gap between the container and the lid.
- the biological sample or chemical in the container is contaminated by viruses or bacteria mixed in liquid nitrogen.
- the infiltrated liquid nitrogen is vaporized in the container to increase the pressure in the container, and when the user opens the container lid, There is a risk that the lid may come off.
- the present invention has been made in view of the above-described circumstances, and an object of the present invention is to provide a means in which a biological sample or medicine stored inside is hardly contaminated when the biological sample or medicine is stored frozen.
- a cryopreservation container includes a container body having an internal space, and a partition wall that partitions the internal space of the container body into at least a first space and a second space, and the container body Is liquid-tightly sealed in the first space and has an opening communicating with the outside in the second space.
- the second space is liquid-tight by welding the container body. It can be sealed.
- a sample to be cryopreserved such as a biological sample or a medicine
- the second space is hermetically sealed by welding. Thereby, it is suppressed that liquid nitrogen etc. permeate into the 2nd space.
- a portion corresponding to the first space of the container body is cut and opened.
- An opening is formed in the partition wall, and the sample stored in the second space is taken out through the opening.
- the partition wall is not exposed to the external environment, it is possible to suppress contamination of the biological sample and the medicine stored in the second space through the opening of the partition wall and the device for opening the partition wall.
- the second space can be sealed by the high frequency welding of the container body.
- the portion of the container body that divides the second space has a neck portion whose outer dimension is smaller than an end portion that divides the opening of the second space.
- ⁇ Welding defects are less likely to occur due to the neck of the container body being welded.
- the container body has translucency to transmit visible light.
- the state of the sample in the container can be visually recognized from the outside.
- the partition wall includes a cylindrical portion that can be inserted into the internal space of the container body, and a wall portion that divides the internal space of the cylindrical portion along a direction intersecting the axial direction of the cylindrical portion. And is inserted into the internal space of the container body, and the cylindrical portion is welded to the container body.
- Forming is easy because the container body and the partition wall are made of different members.
- the container body and the partition wall are formed of separate members, the strength around the partition wall in the cryopreservation container is stronger than the other parts. Therefore, it becomes easy to use a member that passes through the partition wall and takes out the sample in the second space.
- the partition wall is connected to the through hole penetrating the wall portion and sealed to the through hole, and the connecting portion with the wall portion is broken. And a folding bar for opening the through hole.
- the cryopreservation container system has a needle tip that can be inserted into the cryopreservation container and the internal space of the container body and can penetrate the partition wall.
- a needle member having a flow path that opens at the tip and opens at a base end opposite to the needle tip.
- the sample in the second space can be taken out through the internal space of the needle member, with the needle tip portion of the needle member penetrating the partition wall.
- FIG. 1 is a perspective view of a cryopreservation container 10.
- 2A is a cross-sectional view of the cryopreservation container 10 cut along the cutting plane II (A) -II (A) shown in FIG.
- FIG. 2B is a cross-sectional view of the cryopreservation container 10 cut along the cutting plane II (B) -II (B) shown in FIG.
- FIG. 3 is an exploded perspective view of the container body 11 and the partition wall 12.
- FIG. 4 is a cross-sectional view of the partition wall 12 cut along the cutting plane IV-IV shown in FIG.
- FIG. 5 is a perspective view of the needle member 41.
- FIG. 6 is a cross-sectional view of the needle member 41 cut along the cutting plane VI-VI shown in FIG. FIGS.
- FIGS. 7A to 7C are diagrams schematically showing a cryopreservation container 10 for explaining a method of cryopreserving by putting a liquid therein.
- FIGS. 8A to 8D are diagrams schematically showing a cryopreservation container system 40 for explaining a method of taking out a liquid from the inside of the cryopreservation container 10.
- FIG. 9 is a diagram for explaining a modified folding rod 60.
- 10A and 10B are cross-sectional views showing modifications of the position and shape of the wall portion 31 of the partition wall 12.
- the cryopreservation container system 40 includes the cryopreservation container 10 (see FIG. 1) and a needle member 41 (see FIG. 5).
- the cryopreservation container 10 includes a container body 11 and a partition wall 12.
- the container body 11 is generally cylindrical and has an internal space 13.
- the container body 11 has an opening 22 at one end 16 in the direction along the axis 101 and is liquid-tightly closed at the other end 17 by high-frequency welding.
- a neck portion 19 is formed in a part between the end portions 16 and 17, the outer diameter dimension of which is smaller than the outer diameter dimension of the other portions.
- a part of the internal space 13 defined by the neck portion 19 to the end portion 17 is a space in which liquid is stored.
- a part of the internal space 13 defined by the end portion 16 from the neck portion 19 is a space for injecting liquid into the internal space of the cryopreservation container 10 toward the end portion 17.
- the outer diameter of the container body 11 other than the neck portion 19 is arbitrarily designed in consideration of the volume of liquid that can be stored in the cryopreservation container 10, and the outer diameter of a known screw cap type container. If it is about the same level, a case that can accommodate a plurality of screw cap type containers in alignment can be used.
- the outer diameter dimension of the neck portion 19 and the dimension along the direction along the axis 101 are designed in consideration of easy high-frequency welding described later.
- the container body 11 is preferably formed of a material that is easy for a user to cut a part of the container body 11 using a tool such as scissors or a cutter. Moreover, it is preferable that the container main body 11 has the temperature resistance which can endure the temperature at the time of freezing with liquid nitrogen. Moreover, it is preferable to have translucency which can visually recognize the liquid level, the frozen state, etc. of the liquid stored in the internal space 13 of the container body 11. Furthermore, it is preferable that the container main body 11 is easy to liquid-tightly seal the internal space 13 by high frequency welding or the like.
- the material of the container body 11 includes ethylene-vinyl acetate copolymer, vinyl chloride copolymer, ethylene-methyl methacrylate copolymer, low density polyethylene, high density polyethylene, ultra high molecular weight polyethylene, nylon. , Polyurethane, polypropylene, polyester, polystyrene, polyimide, polyacetal, phenolic resin, urea resin, epoxy resin, ABS resin, polyethylene terephthalate and other thermoplastic resins, and ethylene has sufficient temperature resistance. -Vinyl acetate copolymers are preferably used.
- the container body 11 is manufactured, for example, by blow molding a thermoplastic resin.
- the partition wall 12 has a cylindrical portion 30 and a wall portion 31.
- the cylindrical portion 30 is generally cylindrical and has an internal space 32.
- the end portions 33 and 34 in the direction along the axis 101 of the cylindrical portion 30 are both open.
- the cylindrical portion 30 has a tapered shape whose outer diameter decreases from the end portion 33 toward the end portion 34.
- the outer diameter size of the cylindrical portion 30 at the end portion 34 is smaller than the inner diameter size near the end portion 17 of the container body 11. Thereby, the partition wall 12 becomes easy to insert from the edge part 34 to the edge part 17 of the container main body 11 which is not sealed yet.
- the cylindrical portion 30 is formed with a notch 35 extending along the direction along the axis 101 at the end 34.
- a pair of notches 35 are formed at positions that are 180 ° rotationally symmetric with respect to the axis of the cylindrical portion 30.
- Each notch 35 extends to the vicinity of the wall 31 that partitions the internal space 32 of the cylindrical portion 30.
- the wall portion 31 is a member that partitions the internal space 32 of the cylindrical portion 30 into an end portion 33 side and an end portion 34 side.
- the wall portion 31 extends in a direction that intersects the direction along the axis 101 of the cylindrical portion 30.
- the thickness of the wall 31 is appropriately set to such an extent that the user can easily penetrate the needle member 41.
- the partition wall 12 is preferably made of the same material as the container body 11 in consideration of being bonded to the container body 11 by high frequency welding or the like. Moreover, the partition wall 12 is manufactured by injection-molding a thermoplastic resin, for example.
- the partition wall 12 is inserted from the end portion 34 into the end portion 17 of the container body 11 before being sealed. After the partition wall 12 is inserted into the internal space 13 of the container main body 11, most of the portion where the partition wall 12 is present near the end 17 of the container main body 11, preferably the end 34 from the wall 31. When the portion where the side portion exists is welded at high frequency, the end portion 17 of the container main body 11 is sealed in a liquid-tight manner, and the partition wall 12 is welded to the container main body 11 to be integrated.
- the vicinity of the end 17 of the container main body 11 is reduced in diameter along the outer diameter of the partition wall 12, and the inner surface of the container main body 11 near the end 17 of the cylindrical portion 30 of the partition wall 12 is Weld with the outer surface.
- the end on the second space 15 side where the diameter is reduced by welding with the partition wall 12 is substantially the same position in the direction along the wall portion 31 and the axis 101 of the partition wall 12. It is. A portion of the container body 11 that is closer to the end portion 17 than the partition wall 12 is sealed by welding.
- the partition wall 12 welded to the container main body 11 has, by the wall portion 31, the internal space 13 of the container main body 11, the first space 14 located on the end portion 17 side and the second space 15 located on the end portion 16 side. Divide into and.
- the needle member 41 As shown in FIGS. 5 and 6, the needle member 41 has a needle tip portion 42 and a proximal end portion 43. The needle member 41 has a flange portion 49 that extends in the direction intersecting the direction along the axis 101 at the base end portion 43.
- the needle tip portion 42 has a cylindrical shape and is tapered toward the tip, and has a sharp tip.
- the outer diameter dimension of the needle tip portion 42 is smaller than each inner diameter dimension of the first space 14 and the second space 15 in the cryopreservation container 10.
- a through hole 45 that communicates the outside and the internal space 48 is formed near the tip of the needle tip portion 42.
- the through holes 45 are formed at equal intervals at three locations around the axis 102 of the needle tip portion 42.
- positioning of the through-hole 45 are not specifically limited,
- the through-hole 45 may be formed in two places in the needle tip part 42, and may be formed in four or more places.
- the distance between the through hole 45 and the flange portion 49 in the direction along the axis 102 is longer than the distance between the wall portion 31 and the end portion 33 in the partition wall 12.
- the outer diameter size of the base end portion 43 is larger than the outer diameter size of the needle tip portion 42.
- the outer diameter of the base end 43 is approximately the same as or slightly larger than the inner diameter of the first space 14 in the cryopreservation container 10.
- the proximal end portion 43 forms one internal space 48 together with the needle tip portion 42.
- An end 46 of the base end 43 is open. That is, the internal space 48 communicates with the outside through the through hole 45 and the end portion 46.
- the needle member 41 is formed of a material that allows the needle tip portion 42 to penetrate the wall portion 31 of the partition wall 12 of the cryopreservation container 10 by a user operation.
- the needle member 41 can be manufactured by injection molding a thermoplastic resin such as acrylonitrile-butadiene-styrene copolymer synthetic resin or polycarbonate, polystyrene, polyethylene, or polypropylene.
- cryopreservation container system 40 [How to use cryopreservation container system 40] Hereinafter, a method of using the cryopreservation container system 40 will be described with reference to FIGS. 7 (A) to (C) and FIGS. 8 (A) to (C).
- a biological sample such as a cell suspension or a liquid 70 such as a medicine is injected into the cryopreservation container 10.
- An instrument such as a pipette is used for injecting the liquid.
- the user inserts a tip such as a pipette into the opening 22 and injects the liquid from the pipette or the like into the second space 15 of the cryopreservation container 10.
- the injected liquid 70 is stored in the second space 15 of the cryopreservation container 10.
- the neck 19 of the cryopreservation container 10 is high-frequency welded as shown in FIG.
- the high frequency welding is performed using a device capable of irradiating the neck portion 19 with a high frequency with the neck portion 19 sandwiched therebetween, that is, a so-called high frequency sealer.
- the neck portion 19 is sandwiched, the inner surfaces facing each other at the neck portion 19 are in close contact with each other, and the inner surfaces that are in close contact with each other when the high frequency is irradiated are welded.
- the high-frequency welding at the neck portion 19 may be performed at two locations (referred to as welding portions 51 and 52, respectively) having different positions in the direction along the axis 101. preferable.
- the cryopreservation container 10 is cut
- the cryopreservation container 10 including the second space 15 from which a part on the end 17 side is separated is cooled by being immersed in liquid nitrogen, whereby the liquid 70 stored in the second space 15 is frozen. . After freezing the liquid 70, the cryopreservation container 10 is stored in a deep freezer or the like.
- the cryopreservation container 10 When the cryopreserved liquid 70 is taken out from the cryopreservation container 10, the cryopreservation container 10 is left at room temperature or the like, and the liquid 70 frozen in the second space 15 is thawed. And the cryopreservation container 10 is cut
- the cutting position 53 substantially coincides with the position of the end portion 33 of the partition wall 12 on the axis 101. Thereby, the first space 14 of the cryopreservation container 10 is opened.
- the first space 14 and the second space 15 are partitioned by the wall portion 31 of the partition wall 12, even if the cryopreservation container 10 is cut at the cutting position 53, the second space 15 is not exposed to the outside.
- a method for cutting the cryopreservation container 10 for example, a method using a cutting instrument such as scissors is employed. Further, a cut along the cutting position 53 may be formed on the periphery of the cryopreservation container 10 so that it is not necessary to use a cutting instrument.
- the user inserts the needle member 41 from the needle tip portion 42 into the first space 14 of the cryopreservation container 10. As shown in FIG. Then, the needle tip portion 42 is further advanced toward the second space 15 from the state in which the sharp tip of the needle tip portion 42 is in contact with the wall portion 31 of the partition wall 12, as shown in FIG. As described above, the needle tip portion 42 penetrates the wall portion 31. Further, as shown in FIG. 8C, the process proceeds until the through hole 45 of the needle tip portion 42 reaches the second space 15. The distance in the direction along the axis 102 between the through hole 45 and the flange portion 49 in the needle member 41 is longer than the distance between the wall portion 31 and the end portion 33 in the partition wall 12, and as shown in FIG.
- the needle tip of the needle member 41 is brought into contact with the flange portion 49 of the needle member 41 before contacting the container body 11.
- the part 42 penetrates the wall part 31 of the partition wall 12, and the through hole 45 is located on the second space 15 side from the wall part 31 of the partition wall 12.
- the position of the through hole 45 in the second space 15 is such that, for example, the step surface formed on the outer peripheral surface of the needle member 41 closer to the needle tip portion 42 than the flange portion 49 is in the first space 14 of the cryopreservation container 10.
- the through hole 45 of the needle member 41 is positioned slightly closer to the second space 15 side than the wall portion 31 of the partition wall 12.
- the liquid 70 stored in the second space 15 is placed on the wall 31 side by positioning the cryopreservation container 10 above the needle member 41 in the direction of gravity. Move to. In this state, the liquid 70 stored in the second space 15 can flow out to the outside through the through hole 45 of the needle member 41, the internal space 48, and the opening of the end portion 46.
- a suction member such as a syringe
- the liquid 70 stored in the second space 15 can be sucked into the syringe or the like.
- the internal space such as a tube or a syringe is continuous as the second space 15 and the closed space, so that the liquid 70 stored in the second space 15 can be taken out without contacting with the outside air. Further, since the through hole 45 of the needle member 41 is located in the vicinity of the wall portion 31 of the partition wall 12, the liquid 70 remaining in the second space 15 can be reduced.
- the liquid 70 to be cryopreserved such as a biological sample or a medicine
- the second space 15 is hermetically sealed by welding.
- the infiltration of liquid nitrogen or the like into the second space 15 is suppressed.
- the cryopreservation container 10 is opened, the first space 14 is opened, and thereafter, the wall portion 31 of the partition wall 12 is penetrated by the needle member 41, so that the cryopreservation is performed when the first space 14 is opened.
- the substance adhering to the outer surface of the container 10 or the like is prevented from entering the second space 15.
- the second space 15 is hermetically sealed by high frequency welding, poor welding is suppressed.
- cryopreservation container 10 since the cryopreservation container 10 has translucency, the state of the liquid 70 stored in the second space 15 can be easily visually recognized from the outside, for example, when freezing or thawing.
- cryopreservation container 10 is constituted by the container main body 11 and the partition wall 12, the container main body 11 and the partition wall 12 can be manufactured by employing different molding methods.
- the cylindrical portion 30 and the container main body 11 overlap each other around the wall portion 31 of the partition wall 12, the strength around the wall portion 31 is stronger than the strength at other portions of the container main body 11. Become. Therefore, since the needle member 41 is firmly supported around the wall portion 31 of the partition wall 12, an operation for taking out the biological sample and the medicine from the second space 15 using a member such as the needle member 41 is easy. .
- the liquid can be easily taken out from the second space 15 of the cryopreservation container 10 to the outside.
- the mode in which the liquid stored in the second space 15 of the cryopreservation container 10 is taken out to the outside using the needle member 41 is described, but the needle member 41 is not used.
- the liquid may be taken out from the second space 15.
- the needle member 41 or the like is removed, and the second space is passed through the through hole of the wall portion 31.
- the liquid 70 may flow out from 15. Since the partition wall 12 is formed with the notch 35, the liquid 70 does not remain between the inner surface of the container main body 11 that partitions the second space 15 and the outer surface of the partition wall 12, and passes through the notch 35. It can flow out from the second space 15 to the outside.
- a folding rod 60 may be provided on the wall portion 31 of the partition wall 12.
- the folding bar 60 is a bar connected to the wall 31 so as to close the through hole 47 formed in the wall 31 of the partition wall 12 in the first space 14 of the cryopreservation container 10.
- one end of the folding rod 60 is connected to a part of the wall 31 that defines the through hole 47 by a connecting portion 61.
- the connecting portion 61 is set to be thin enough to be easily broken by the force applied by the user. As described above, after the first space 14 of the cryopreservation container 10 is opened, when the user applies a force to the folding rod 60, the connecting portion 61 is broken, and the through hole 47 is formed between the first space 14 and the second space 14.
- the shape of the folding bar 60 is an example, and any shape can be adopted as long as the user can apply a force to break the connecting portion 61.
- the cryopreservation container 10 is held in a posture in which the wall portion 31 is the lowest in the direction of gravity in the second space 15, and the needle member When the liquid 70 flows out from the second space 15 through the through-hole 45 or the through-hole 47 of the 41, the liquid 70 remaining in the second space 15 can be reduced.
- the center of the wall portion 31 of the partition wall 12 (the position through which the axis 101 passes) has a funnel shape protruding from the other portion to the end portion 17 of the container body 11. Similarly, the amount of the liquid 70 remaining in the second space 15 can be reduced.
- the neck portion 19 is formed in the cryopreservation container 10 so that high-frequency welding is easily and reliably performed. 19 may not be provided in the cryopreservation container 10.
- cryopreservation container 10 is integrally formed after the container main body 11 and the partition wall 12 are separately molded, but the container main body 11 and the partition wall 12 may be integrally formed. Good.
- the container body 11 may employ a known technique such as thermal welding other than high-frequency welding for welding the container body 11 and the partition wall 12 or for sealing the second space 15.
- thermal welding other than high-frequency welding
- the material of the container body 11 is low density polyethylene, high density polyethylene, ultrahigh molecular weight polyethylene, nylon, polyester, polystyrene, polyimide, ethylene-vinyl acetate. Polymers and laminates of these are preferred.
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Abstract
Description
凍結保存容器システム40は、凍結保存容器10(図1参照)及び針部材41(図5参照)を備える。
図1及び図2に示されるように、凍結保存容器10は、容器本体11及び仕切壁12を備える。容器本体11は、概ね円筒形状であり、内部空間13を有する。容器本体11は、軸線101に沿った方向における一方の端部16に開口22を有し、他方の端部17において高周波溶着により液密に閉塞されている。容器本体11には、端部16,17の間の一部において、その外径寸法が、他の部分の外径寸法より小さい首部19が形成されている。首部19から端部17によって区画される内部空間13の一部分が、液体が貯留される空間となる。首部19から端部16によって区画される内部空間13の一部分は、端部17へ向かって液体を凍結保存容器10の内部空間へ注入するための空間である。容器本体11における首部19以外の部分の外径寸法は、凍結保存容器10に貯留可能な液体の容量などを考慮して任意に設計されるが、公知のスクリューキャップ式の容器の外径寸法と同程度であれば、複数のスクリューキャップ式の容器を整列して収容可能なケースなどが利用できるので好適である。首部19の外径寸法や軸線101に沿った方向に沿った寸法は、後述される高周波溶着が行われやすいように考慮して設計される。
図5及び6に示されるように、針部材41は、針先部42と、基端部43と、を有する。また、針部材41は、基端部43において軸線101に沿った方向と交差する方向へ延びるフランジ部49を有する。
以下に、図7(A)~(C)及び図8(A)~(C)を参照しつつ、凍結保存容器システム40の使用方法が説明される。
本実施形態に係る凍結保存容器10によれば、生体試料や薬品などの凍結保存すべき液体70が第2空間15へ注入され、その第2空間15が溶着によって液密に密閉されるので、凍結や保存の際に、第2空間15へ液体窒素などが滲入することが抑制される。凍結保存容器10が開封されるときには、第1空間14が開封され、その後、仕切壁12の壁部31が針部材41によって貫通されるので、第1空間14が開封されるときに、凍結保存容器10の外面などに付着していた物質が第2空間15に進入することが抑制される。
なお、前述された実施形態においては、凍結保存容器10の第2空間15に貯留された液体が、針部材41を用いて外部へ取り出される態様が説明されたが、針部材41を用いることなく、第2空間15から液体が取り出されてもよい。例えば、針部材41や類似の器具により凍結保存容器10の仕切壁12の壁部31に貫通孔が形成された後、針部材41などが取り除かれて、壁部31の貫通孔を通じて第2空間15から液体70が流出されてもよい。仕切壁12には切欠部35が形成されているので、液体70は、第2空間15を区画する容器本体11の内面と仕切壁12の外面との間に残留することなく、切欠部35を通じて第2空間15から外部へ流出可能である。
11・・・容器本体
12・・・仕切壁
13・・・内部空間
14・・・第1空間
15・・・第2空間
19・・・首部
22・・・開口
30・・・筒部
31・・・壁部
40・・・凍結保存容器システム
41・・・針部材
42・・・針先部
43・・・基端部
47・・・貫通孔
48・・・内部空間
60・・・折れ棒
61・・・連結部分
Claims (7)
- 内部空間を有する容器本体と、
上記容器本体の内部空間を少なくとも第1空間及び第2空間に区画する仕切壁と、を備えており、
上記容器本体は、上記第1空間において液密に密閉されており、且つ上記第2空間において外部と連通する開口を有しており、
上記第2空間は、上記容器本体が溶着されることにより液密に密閉可能である凍結保存容器。 - 上記第2空間は、上記容器本体が高周波溶着されることにより密閉可能である請求項1に記載の凍結保存容器。
- 上記容器本体において上記第2空間を区画する部分は、上記第2空間の開口を区画する端部より外形寸法が小さい首部を有する請求項1又は2に記載の凍結保存容器。
- 上記容器本体は、可視光を透過する透光性を有する請求項1から3のいずれかに記載の凍結保存容器。
- 上記仕切壁は、上記容器本体の内部空間に挿入可能な筒部と、当該筒部の内部空間を、当該筒部の軸線方向と交差する方向に沿って区画する壁部と、を有するものであって、上記容器本体の内部空間に挿入されて、上記筒部が上記容器本体と溶着されたものである請求項1から4のいずれかに記載の凍結保存容器。
- 上記仕切壁は、上記壁部を貫通する貫通孔と、上記壁部に連結されて当該貫通孔を封止し、且つ上記壁部との連結部分が破断されることによって、上記貫通孔を開放する折れ棒を有する請求項5に記載の凍結保存容器。
- 請求項1から5のいずれかに記載の凍結保存容器と、
上記容器本体の内部空間に挿入可能であって、上記仕切壁を貫通可能な針先部を有しており、当該針先部において開口し且つ当該針先部と反対の基端部において開口する流路を有する針部材と、を具備する凍結保存容器システム。
Priority Applications (7)
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EP17820140.6A EP3476766B1 (en) | 2016-06-28 | 2017-06-27 | Frozen storage container and frozen storage container system |
CA3029146A CA3029146C (en) | 2016-06-28 | 2017-06-27 | Container and system for sterile storage of frozen liquid sample |
JP2018525170A JP6892643B2 (ja) | 2016-06-28 | 2017-06-27 | 凍結保存容器及び凍結保存容器システム |
AU2017290519A AU2017290519B2 (en) | 2016-06-28 | 2017-06-27 | Frozen storage container and frozen storage container system |
CN201780040321.6A CN109415150B (zh) | 2016-06-28 | 2017-06-27 | 冷冻储存容器以及冷冻储存容器*** |
US16/313,410 US11123264B2 (en) | 2016-06-28 | 2017-06-27 | Frozen storage container and frozen storage container system |
KR1020197002742A KR102353460B1 (ko) | 2016-06-28 | 2017-06-27 | 동결 보존 용기 및 동결 보존 용기 시스템 |
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WO2020078159A1 (zh) * | 2018-10-17 | 2020-04-23 | 广州品知医疗器械有限公司 | 一种封闭式玻璃化冷冻载体 |
JP2021016580A (ja) * | 2019-07-19 | 2021-02-15 | 大日本印刷株式会社 | 容器 |
JP2023535177A (ja) * | 2020-07-23 | 2023-08-16 | クーパーサージカル・インコーポレイテッド | 凍結保存用途のためのキャニスターキャップ |
USD1017829S1 (en) | 2020-11-24 | 2024-03-12 | Nipro Corporation | Cryopreservation container |
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US12029886B2 (en) | 2021-04-13 | 2024-07-09 | Conrad A. Flick, III | Thermoformed medical syringe |
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EP3476766A1 (en) | 2019-05-01 |
JPWO2018003786A1 (ja) | 2019-04-25 |
CN109415150A (zh) | 2019-03-01 |
US20190159968A1 (en) | 2019-05-30 |
EP3476766B1 (en) | 2023-06-21 |
AU2017290519B2 (en) | 2023-04-06 |
EP3476766A4 (en) | 2020-03-11 |
US11123264B2 (en) | 2021-09-21 |
JP6892643B2 (ja) | 2021-06-23 |
KR20190020342A (ko) | 2019-02-28 |
KR102353460B1 (ko) | 2022-01-20 |
AU2017290519A1 (en) | 2019-01-17 |
CA3029146A1 (en) | 2018-01-04 |
CN109415150B (zh) | 2020-09-04 |
CA3029146C (en) | 2024-05-28 |
EP3476766C0 (en) | 2023-06-21 |
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