WO2022137489A1 - プラスチック製キャップ - Google Patents
プラスチック製キャップ Download PDFInfo
- Publication number
- WO2022137489A1 WO2022137489A1 PCT/JP2020/048647 JP2020048647W WO2022137489A1 WO 2022137489 A1 WO2022137489 A1 WO 2022137489A1 JP 2020048647 W JP2020048647 W JP 2020048647W WO 2022137489 A1 WO2022137489 A1 WO 2022137489A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- lip
- rubber stopper
- cap
- plastic cap
- drug
- Prior art date
Links
- 239000004033 plastic Substances 0.000 title claims abstract description 37
- 229920003023 plastic Polymers 0.000 title claims abstract description 37
- 239000003814 drug Substances 0.000 claims abstract description 102
- 229940079593 drug Drugs 0.000 claims abstract description 97
- 229920001971 elastomer Polymers 0.000 claims abstract description 57
- 239000005060 rubber Substances 0.000 claims abstract description 57
- 230000013011 mating Effects 0.000 claims description 46
- 210000000078 claw Anatomy 0.000 claims description 40
- 230000002093 peripheral effect Effects 0.000 claims description 13
- 239000008177 pharmaceutical agent Substances 0.000 abstract 1
- 229920005989 resin Polymers 0.000 description 15
- 239000011347 resin Substances 0.000 description 15
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 11
- 229910052782 aluminium Inorganic materials 0.000 description 11
- -1 vapors Substances 0.000 description 8
- 239000000463 material Substances 0.000 description 6
- 238000004108 freeze drying Methods 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 239000002985 plastic film Substances 0.000 description 4
- 229920006255 plastic film Polymers 0.000 description 4
- 230000001954 sterilising effect Effects 0.000 description 4
- 238000004659 sterilization and disinfection Methods 0.000 description 4
- 239000004743 Polypropylene Substances 0.000 description 3
- 239000000443 aerosol Substances 0.000 description 3
- 238000010079 rubber tapping Methods 0.000 description 3
- 238000007789 sealing Methods 0.000 description 3
- 229920003002 synthetic resin Polymers 0.000 description 3
- 239000000057 synthetic resin Substances 0.000 description 3
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- 238000000034 method Methods 0.000 description 2
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- 229920005668 polycarbonate resin Polymers 0.000 description 2
- 239000004431 polycarbonate resin Substances 0.000 description 2
- 229920001225 polyester resin Polymers 0.000 description 2
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- 239000004800 polyvinyl chloride Substances 0.000 description 2
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- 229920002725 thermoplastic elastomer Polymers 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- BQCIDUSAKPWEOX-UHFFFAOYSA-N 1,1-Difluoroethene Chemical group FC(F)=C BQCIDUSAKPWEOX-UHFFFAOYSA-N 0.000 description 1
- JMMZCWZIJXAGKW-UHFFFAOYSA-N 2-methylpent-2-ene Chemical compound CCC=C(C)C JMMZCWZIJXAGKW-UHFFFAOYSA-N 0.000 description 1
- OMIHGPLIXGGMJB-UHFFFAOYSA-N 7-oxabicyclo[4.1.0]hepta-1,3,5-triene Chemical class C1=CC=C2OC2=C1 OMIHGPLIXGGMJB-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- JGZXFYJBOHKPTL-UHFFFAOYSA-N C=C.C=C.F.F.F.Cl Chemical group C=C.C=C.F.F.F.Cl JGZXFYJBOHKPTL-UHFFFAOYSA-N 0.000 description 1
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 1
- 239000005977 Ethylene Substances 0.000 description 1
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 description 1
- 244000043261 Hevea brasiliensis Species 0.000 description 1
- 125000002066 L-histidyl group Chemical group [H]N1C([H])=NC(C([H])([H])[C@](C(=O)[*])([H])N([H])[H])=C1[H] 0.000 description 1
- 229930182556 Polyacetal Natural products 0.000 description 1
- 239000005062 Polybutadiene Substances 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 230000004931 aggregating effect Effects 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 229940041181 antineoplastic drug Drugs 0.000 description 1
- 229920005549 butyl rubber Polymers 0.000 description 1
- 229920006026 co-polymeric resin Polymers 0.000 description 1
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- 230000006866 deterioration Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- HQQADJVZYDDRJT-UHFFFAOYSA-N ethene;prop-1-ene Chemical group C=C.CC=C HQQADJVZYDDRJT-UHFFFAOYSA-N 0.000 description 1
- 125000000816 ethylene group Chemical group [H]C([H])([*:1])C([H])([H])[*:2] 0.000 description 1
- 229910052731 fluorine Inorganic materials 0.000 description 1
- 239000011737 fluorine Substances 0.000 description 1
- 229920005555 halobutyl Polymers 0.000 description 1
- 229920001519 homopolymer Polymers 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 229920003049 isoprene rubber Polymers 0.000 description 1
- 238000005304 joining Methods 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 229920003052 natural elastomer Polymers 0.000 description 1
- 229920001194 natural rubber Polymers 0.000 description 1
- JRZJOMJEPLMPRA-UHFFFAOYSA-N olefin Natural products CCCCCCCC=C JRZJOMJEPLMPRA-UHFFFAOYSA-N 0.000 description 1
- 229920002492 poly(sulfone) Polymers 0.000 description 1
- 229920002857 polybutadiene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920005678 polyethylene based resin Polymers 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 229920005672 polyolefin resin Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920005673 polypropylene based resin Polymers 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 229920003051 synthetic elastomer Polymers 0.000 description 1
- 239000005061 synthetic rubber Substances 0.000 description 1
- 229920001897 terpolymer Polymers 0.000 description 1
- BFKJFAAPBSQJPD-UHFFFAOYSA-N tetrafluoroethene Chemical group FC(F)=C(F)F BFKJFAAPBSQJPD-UHFFFAOYSA-N 0.000 description 1
- 125000000383 tetramethylene group Chemical group [H]C([H])([*:1])C([H])([H])C([H])([H])C([H])([H])[*:2] 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 229920005992 thermoplastic resin Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
Images
Classifications
-
- 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
- A61J1/1412—Containers with closing means, e.g. caps
-
- 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
- A61J1/1412—Containers with closing means, e.g. caps
- A61J1/1425—Snap-fit type
-
- 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
- A61J1/06—Ampoules or carpules
- A61J1/065—Rigid ampoules, e.g. glass ampoules
-
- 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
-
- 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
- B65D41/00—Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge aperture; Protective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
- B65D41/02—Caps or cap-like covers without lines of weakness, tearing strips, tags, or like opening or removal devices
- B65D41/04—Threaded or like caps or cap-like covers secured by rotation
- B65D41/0435—Threaded or like caps or cap-like covers secured by rotation with separate sealing elements
- B65D41/0442—Collars or rings
-
- 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
- B65D41/00—Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge aperture; Protective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
- B65D41/02—Caps or cap-like covers without lines of weakness, tearing strips, tags, or like opening or removal devices
- B65D41/28—Caps combined with stoppers
-
- 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
- B65D55/00—Accessories for container closures not otherwise provided for
- B65D55/02—Locking devices; Means for discouraging or indicating unauthorised opening or removal of closure
- B65D55/022—Locking devices; Means for discouraging or indicating unauthorised opening or removal of closure with ratchet effect between relatively rotating parts
-
- 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
- B65D2255/00—Locking devices
- B65D2255/20—Locking devices with coacting elements, e.g. ratchet and pawl, formed integrally in the container and closure or dispensing device, e.g. spout, for permanently preventing removal of the latter
Definitions
- the present invention relates to a plastic cap. More specifically, it can be safely applied to a closed drug transport system, prevents drug leakage from the drug container, and has multiple connection adapters when mating with the medical device of the closed drug transport system. Regarding plastic caps that do not require.
- the above-mentioned drug container is used after the drug is stored, the mouth of the drug container is sealed with a rubber stopper, and the inside of the drug container is sealed. Furthermore, if the drug container is subjected to heat sterilization or other treatment, the rubber stopper may come off from the drug container. Therefore, the rubber stopper plugged into the mouth of the drug container should be removed from the drug container.
- an aluminum or plastic cap is generally fitted under the lip of the mouth of the drug container while wrapping the rubber stopper.
- the aluminum cap which has been widely used in the past, is crimped under the lip of the mouth of the drug container due to its excellent aluminum deformability, and exhibits excellent anti-detachment property of the rubber stopper.
- chemical filling work is often performed in clean rooms, and there is a problem that aluminum fine particles are generated and scattered due to collisions between caps during manufacturing and use, and aluminum is separated after use. There is a problem that it is difficult to dispose of it, and in recent years there has been a tendency to avoid using aluminum caps.
- plastic caps For this reason, the application of plastic caps is increasing. On the other hand, for example, the drug is freeze-dried in the drug container and then sealed, and the diversification of the drug contained in the drug container is remarkable. Therefore, a highly processable plastic cap is used.
- various proposals have been made in which various functions are imparted by devising a shape (see Patent Documents 2, 3 and the like).
- the plastic cap has a problem that the engagement with the pharmaceutical container is inferior to that of the aluminum cap as compared with the aluminum cap. This is different from the aluminum cap in which the aluminum is freely deformed along the lip of the drug container mouth and is easily and firmly crimped to the drug container mouth.
- an engaging claw is provided inside, and this is fixed by engaging with the lip of the mouth of the drug container.
- both the cap and the pharmaceutical container are required to have high dimensional accuracy because the stopper is difficult.
- both the cap and the pharmaceutical container are made of synthetic resin, the shrinkage deformation during cooling is calculated and molded into a predetermined shape, so that the dimensional accuracy of both can be improved.
- the dimensional error is an order of magnitude larger than that of synthetic resin pharmaceutical containers, so it is difficult to sufficiently prevent the cap from coming off even if the dimensional accuracy of the plastic cap is improved. There is a problem.
- the applicant has already addressed this issue with a rubber stopper that has been plugged into the mouth of the drug container not only for synthetic resin drug containers but also for glass drug containers that are inferior in dimensional accuracy.
- a plastic cap for a pharmaceutical container that can ensure the closeness of the product (see Patent Document 4).
- the inner diameter of the skirt portion is formed larger than the outer diameter of the lip of the pharmaceutical container, and a plurality of ridges are formed on the inner surface of the skirt portion in the direction perpendicular to the top surface portion to prevent dimensional error. It has a structure that absorbs.
- the medicine bottle adapter is aligned with the medicine bottle at the lower part of the adapter.
- the top of the adapter has an upright female connector for joining to a needleless syringe. Therefore, not only the medicine bottle side at the bottom of the adapter but also the top of the adapter fits into the medical equipment (including closed connection equipment) used in the closed drug transfer system, so multiple connection adapters are required. (See Patent Document 5).
- the present invention can be safely applied to a closed-type drug transport system, prevents the drug from leaking from the drug container, and when combined with the medical device of the closed-type drug transport system, a plurality of them.
- the plastic cap (F) attached to the pharmaceutical container (A) and combined with the medical device used in the closed drug transport system.
- the cap (F) has a top surface portion (F1) having a mating portion (F11) in the center, and a cylindrical skirt portion (F2) that hangs down from the outer periphery of the top surface portion (F1) and has an open lower end. And a shaving member (F3) to be sewn inside the skirt portion (F2).
- the mating portion (F11) has a lip (F112) and a middle cylinder (F113) hanging from the lip (F112).
- the skirt portion (F2) provides a plastic cap having a lower rubber stopper (F211) inside and the lower rubber stopper (F211) having an O-ring shape.
- the lower rubber stopper (F211) may be convex upward.
- the mating portion (F11) is composed of an upper surface (F115), an upper rubber stopper (F111), and a lower surface (F114) at the lip (F112), and the contact surface with the medical device is formed. At least one point may be in contact with the lower surface (F114) or the upper surface (F115) of the mating portion (F11).
- the mating member (F3) may have a locking claw (F32) inside in order to engage with the lip (A2) of the pharmaceutical container (A).
- a plurality of locking claws (F31) may be provided on the outer peripheral surface of the mating member (F3).
- the outer peripheral surface of the mating member (F3) has a concave portion (F33) for provisionally engaging with the skirt portion (F2), and a convex portion (F23) on the opening side of the skirt portion. You may have.
- the locking claw when the force by which the convex portion (F23) gets over the locking claw (F31) is f3, the locking claw (the locking claw) (from the upper surface to the lower surface of the lip (A2)).
- the force F32) may be larger than the overcoming force f2.
- a plurality of drugs can be safely applied to a closed drug transport system, prevent drug from leaking from a drug container, and when combined with a medical device of the closed drug transport system. It is possible to provide a plastic cap that does not require a connection adapter.
- the effects described here are not necessarily limited to these, and may be any of the effects described in the present specification.
- FIG. 1 is a diagram showing an example of an embodiment of the plastic cap F according to the present invention.
- the plastic cap F according to the present invention is a cap that can be attached to a medical container A, combined with a medical device used in a closed system transfer device (CSTD), and applied to CSTD.
- CSTD closed system transfer device
- the closed drug delivery system may refer to both a closed connection device (not shown) and a closed administration route, but in the present specification, it mainly refers to the former closed connection device.
- the cap F has a top surface portion F1 having a mating portion F11 in the center, a cylindrical skirt portion F2 hanging from the outer periphery of the top surface portion F1 and having an open lower end, and a skirt inside the skirt portion F2. It is composed of a matching member F3 and a matching member F3.
- the merging portion F11 has a lip F112 and a middle cylinder F113 hanging from the lips F112, and the merging portion F11 assembles with a medical device which is a closed connection device.
- the medical device is, for example, a vial adapter having a general needle portion.
- the mating portion F11 has an upper rubber stopper F111 having a downwardly convex shape, and an upper portion at the lower end of the middle cylinder F113 and at the opening of the skirt portion F2. It has a lower rubber stopper F211 that is convex in the direction.
- the lower rubber stopper F211 has an O-ring shape.
- the upper rubber stopper F111 can be punctured with a needle or the like of a closed type connecting device.
- the vial adapter (not shown), which is the closed connection device, has a housing
- the vial adapter provided with a spike needle is aligned with the mating portion F11 from the upper surface, and the lip F112 is provided in the housing. At least one point is in contact with the lower surface F114 or the upper surface F115 constituting the outer edge portion. Therefore, a plurality of vial adapters are not required when attaching the closed connection device to the fitting portion F11.
- the skirt portion F2 has a matching member F3 provided with at least two or more reverse-shaped locking claws F32 when the skirt portion F2 is fitted to the lip A2 of the pharmaceutical container A.
- the mating member F3 and the lower rubber stopper F211 are in contact with the lip A2 and are in a mated state. The mating member F3 and the lower rubber stopper F211 are not in contact with each other. This is because the tapping pressure increases due to contact with each other.
- the drug can be transferred while maintaining its airtightness, and the aerosol, steam, and liquid from the inside of the drug container A can be transferred. While preventing exposure due to leakage or the like, the inside of the drug container A can be maintained as sterile and can be safely applied to a closed drug transport system. Further, since the lower rubber stopper F211 has an O-ring shape, it is possible to prevent the needle tip from reaching the agent and not being able to suck the agent when the upper surface of the upper rubber stopper F111 is punctured.
- the lower rubber stopper F211 having an ⁇ ring shape is convex toward the upper side of the middle cylinder F113. As a result, the lower rubber stopper F211 comes into contact with the inner wall surface of the skirt portion F2 of the cap F, so that the lower rubber stopper F211 can be prevented from falling off.
- the mating portion F11 has a substantially T-shape, and the lip F112 is composed of an upper surface F115, an upper rubber stopper F111, and a lower surface F114, and the contact surface with the medical device is the upper surface F115. Alternatively, at least one point is in contact with the lower surface F114.
- the cap F of the present invention can be more reliably combined with the medical device used for CSTD.
- FIG. 2 illustrates a state in which the drug container A is half-stamped in an example of the embodiment of the cap F according to the present invention
- FIG. 3 shows an example of the embodiment of the cap F according to the present invention in the drug container A. The state of being fully plugged will be described.
- the cap F can be held in a state of being half-plugged into the drug container A by the aggregating member F3 provided on the skirt portion F2 of the cap F.
- the half-plugged state is a state in which the lower rubber stopper F211 is separated from the lip A2 of the drug container A.
- the concave portion F33 of the mating member F3 is fitted into the convex portion F23 provided inside the skirt portion F2, and a part of the locking claw F32 is in contact with the upper surface of the lip A2.
- the plastic cap F is temporarily fixed to the lip A2 of the drug container A, and the inside of the drug container A and the outside air are the lip A2 and the lowermost surface of the skirt portion F2.
- FIG. 3 shows a state in which the skirt portion F2 of the cap F is completely plugged into the drug container A by the mating member F3.
- the fully plugged state is a state in which the lower rubber stopper F211 is in contact with the lip A2 of the drug container A. Further, the fully plugged state means that the locking claw F31 provided on the outside of the mating member F3 is fitted into the recess F21 provided on the inside of the skirt portion F2 and is in contact with the upper surface of the lip A2. The stop claw F32 slides on the side surface of the lip A2 and is locked by the lower surface of the lip A2.
- the plastic cap F is in a state of being locked to the lip A2 of the drug container A, and the lip A2 and the lower rubber stopper F211 come into contact with each other and are on the lip A2. Since the space (gap) of the drug container A is blocked, the inside of the drug container A and the outside air do not communicate with each other.
- the cap F according to the present invention is extremely effective when the drug filled in the drug container A is freeze-dried.
- the cap F according to the present invention for example, in the freeze-drying step, the gas generated in the pharmaceutical container A can be quickly exhausted along the space (gap) in the lip A2, and at the same time, freeze-drying can be performed.
- the rubber stopper can be stoppered very quickly by using a stoppering device or the like after the completion. Therefore, the airtightness inside the pharmaceutical container A can be ensured.
- the force (f1 to f3) relationship in which the skirt portion F2 overcomes each member will be described, focusing on the movement for covering the mating member F3.
- the force that the convex portion F23 provided on the skirt portion F2 overcomes the concave portion F33 provided on the outer peripheral surface of the mating member F3 is f1
- the force that the locking claw F32 overcomes the lip A2 is f2
- f2> f1 It becomes a relationship.
- the step of overcoming the concave portion F33 by the convex portion F23 provided on the skirt portion F2 is referred to as a first locking step.
- the skirt portion F2 and the mating member F3 have a relationship of f3> f2> f1, but in the present invention, the relationship between f1 and f2 is not particularly limited, and the convex portion F23 provided on the skirt portion F2.
- the force f3 overcoming the locking claw F31 provided on the outer peripheral surface of the mating member F3 may be larger than the force f2 overcoming the locking claw F32 provided inside the mating member F3 with the lip A2. That is, the relationship may be f3> f2. Therefore, in the present invention, the skirt portion F2 and the mating member F3 may have a relationship of f3> f1> f2.
- the locking claw F32 gets over the lip A2
- the locking claw F32 on the upper surface of the lip A2 moves from the side surface of the lip A2 along the lower surface of the lip A2.
- the locking claw F32 moves to the lower surface of the lip A2, the convex portion F23 gets over the locking claw F31 provided on the outer peripheral surface of the mating member F3, and the locking claw F31 fits into the concave portion F21. It will be in a plugged state. Therefore, through the first locking step and the second locking step, the skirt portion F2 is covered from the outside of the mating member F3, and the skirt portion F2 is in a state of being fully plugged more firmly, which is safe. It can be applied to a closed drug transport system and can prevent the drug from leaking from the drug container A.
- FIG. 4 is a perspective view of an example of the embodiment of the cap F according to the present invention from above
- FIG. 5 is a perspective view of an example of the embodiment of the cap F according to the present invention as viewed from below.
- FIG. 6 is a perspective view of an example of the embodiment of the mating member F3 of the cap F according to the present invention as viewed from above.
- the outer diameter of the skirt portion F2 is larger than the outer diameter of the lip F112 and the middle cylinder F113.
- the outer diameter of the lip F112 is compared with the outer diameter of the middle cylinder F113, the outer diameter of the lip F112 is larger than the outer diameter of the middle cylinder F113.
- a plurality of locking claws F31 are provided on the outer peripheral surface of the mating member F3.
- the locking claw 31 may have, for example, a convex shape extending in the outer diameter direction.
- a plurality of locking claws F31 are provided on the outer peripheral surface of the mating member F3, and a plurality of locking claws F32 are provided inside, and the locking claws F31 and the locking claws F32 are provided.
- a wall-shaped, rectangularly curved tip member F38 is provided between them.
- the mating member F3 includes a ring-shaped member F36 and a plurality of leg members F37 provided by hanging the ring-shaped member F36.
- the ring-shaped member F36 has a plurality of convex portions F116 and a plurality of concave portions F117 toward the center direction of the ring shape when viewed from the upper surface. Further, the recess F117 is hung down to provide the leg member F37.
- the mating member F3 does not touch the lower rubber stopper F211 and is provided with a convex portion F116 on the upper surface.
- a gap F39 is generated between the lower surface of the top surface portion F1 having the cap F and the upper surface of the lip A2, but the lower rubber stopper F211 is pressed and spreads to the gap F39, so that the lower rubber The contact area between the stopper F211 and the upper surface of the lip A2 is increased, and the airtightness can be improved.
- the plurality of convex portions F116 and the plurality of concave portions F117 are not limited in shape, and may be an annular shape having an edge.
- a reverse-shaped locking claw F32 that fits with the lip A2 of the medical container A is provided inside the leg member F37. Further, on the outside of the leg member F37, a checkered locking claw F31 in contact with the inner wall surface of the skirt portion F2 and a recess F33 for temporary engagement are provided.
- the locking claw F32 provided on the inside of the leg member F37 is thicker than the locking claw F31 provided on the outside. This is to prevent the medical container A from being damaged by being combined with the lip A2. As a result, the cap F and the drug container A can be more firmly fixed in the fully plugged state.
- At least one notch portion F35 is formed in the mating member F3.
- the number of cutout portions F35 is not particularly limited, but it is preferable that a plurality of cutout portions F35 are formed. This makes it possible to improve the flexibility of the mating member F3 and prevent damage such as cracking when the cap F is mated with the pharmaceutical container A.
- the upper rubber stopper F111 and the lower rubber stopper F211 constituting the plastic cap F In order to ensure higher sealing performance in the upper rubber stopper F111 and the lower rubber stopper F211 constituting the plastic cap F according to the present invention, preferred embodiments are shown below. The embodiments described below are for reference only and do not limit the specifications.
- the upper surface of the upper rubber stopper F111 and the lower rubber stopper F211 are rubber base surfaces
- the upper surface of the upper rubber stopper F111 is a rubber base surface
- the lower surface of the upper rubber stopper F111 is laminated with a plastic film, such as silicone. It is preferable that the lubricant of the above is not applied.
- the upper surface of the upper rubber stopper F111 is a rubber bare surface, and if slipperiness is required on the top surface of the upper rubber stopper F111, a plastic film can be laminated.
- a plastic film a general plastic film such as polyethylene, polypropylene, and a fluororesin can be used.
- the material for forming the plastic cap F according to the present invention may be a resin having excellent heat resistance, slipperiness, sterilization resistance and strength, and may be a thermoplastic resin, a thermoplastic elastomer (TPE), or a polyolefin-based material.
- TPE thermoplastic elastomer
- the present invention is not limited to these, and can be appropriately selected. Specifically, for example, fluorine-based resin, polyethylene-based resin, polypropylene-based resin (including PP, copolymer obtained by copolymerizing ethylene group, butylene group, etc. in addition to PP and homopolymer), polyester-based resin (PET), polysulfone-based resin.
- PSF Heavy weight of resin
- PMP methylpentene resin
- PAR polyacrylate resin
- PA polyamide resin
- PPE modified phenylene oxide resin
- cyclic olefin compound or crosslinked polycyclic hydrocarbon compound Resin as a coalescing component, polycarbonate resin (PC), resin modified (grafted) with a polar group of olefin resin, polyacetal (POM) with excellent wear resistance, soft polyvinyl chloride (soft PVC) or thermoplastic It may be polyurethane (TPU) or the like.
- the cap F and the mating member F3 may be formed of the same material or different materials, but have heat resistance that can withstand high-pressure steam sterilization conditions such as 121 ° C. for 20 minutes.
- the material is not limited to these as long as it does not have strength problems such as deterioration and cracking and can be sterilized by radiation sterilization or the like.
- the cap F according to the present invention from plastic, fine particles are not generated even if they rub against each other or collide with each other. Further, since the cap F can be manufactured by, for example, injection molding, the degree of freedom in shape and structure is high.
- the material forming the upper rubber stopper F111 and the lower rubber stopper F211 is, for example, a compound of synthetic rubber such as butyl rubber, isoprene rubber, butadiene rubber, halogenated butyl rubber, ethylene propylene terpolymer, silicon rubber, or a natural rubber.
- the fluororesins to be laminated include, for example, tetrafluoroethylene resin, trifluorochloride ethylene resin, tetrafluoroethylene-hexfluoropropylene copolymer resin, fluorovinylidene resin, fluorovinyl resin, and tetrafluoride.
- An ethylene-ethylene copolymer resin, an ethylene trifluoride chloride-ethylene copolymer resin, or the like can be used.
- a cover D that can be detached with a finger may be integrally provided on the upper surface of the lip F112. That is, the cap F and the cover D may be formed, for example, by being molded by the above-mentioned resin.
- this cover D is not essential in the present invention, it can be provided to prevent contamination of the upper surface of the lip F112 of the cap F. It is preferable that the cover D has one or a plurality of finger hooks D1 formed over the entire circumference or partially formed. The user can easily remove the cover D by putting his / her finger on the finger rest D1 as needed.
- a gas impermeable film that does not allow gas, water vapor, bacteria, etc. to pass through, a gas permeable film that allows gas, water vapor, etc. to pass through, and the like can be mentioned.
- any method may be used as long as it can prevent contamination of the lip F112.
- the upper surface of the lip F112 of the cap F according to the present invention may be covered, and the cover D may be formed with a peelable seal or the like. ..
- the drug container A is filled with a desired drug, and then the drug container A is held in a semi-plugged state with the cap F.
- the skirt portion F2 and the mating member F3 are temporarily mated with each other via the concave portion F33 and the locking claw F23, and the convex portion F32 inside the mating member F3 is attached to the lip A2 of the drug container A.
- Engage. Then, freeze-drying is performed, and after the freeze-drying is completed, the pharmaceutical container A is sealed by using a stopper or the like.
- the plurality of convex portions F32 elastically deform and descend while in contact with the outer peripheral surface of the lip A2, and when the tip of the convex portion F32 passes the outer peripheral surface of the lip A2, the convex portion F32 returns to its original state and is fixed to the drug container A.
- the upper part of the mating member F3 enters the inside of the skirt portion F2, the plurality of locking claws F31 are elastically deformed, and the skirt portion F2 and the mating member F3 are firmly mated.
- the user punctures the upper rubber stopper F111 from the upper surface F115 side using the medical device used for CSTD, and transfers the drug.
- the cap F is fitted into the opening of the drug container A, the drug container A is sealed, and then the cap F is fitted by using a stopper or the like. Not limited.
- the cap according to the present invention is in contact with the lip of the medical container and is in a state of being in contact with each other by the combining member and the lower rubber stopper constituting the present invention. Therefore, even if the rubber stopper is not plugged in the drug container, the drug can be transferred while maintaining its airtightness, and while preventing exposure due to leakage of aerosol, steam, liquid, etc. from the inside of the drug container. , Maintains the sterility inside the drug container, can be safely applied to the closed drug transport system, and further, it does not require multiple connection adapters when integrating with the medical equipment of the closed drug transport system. We can provide a plastic adapter.
Abstract
Description
該キャップ(F)は、中央に篏合部(F11)を有する天面部(F1)と、該天面部(F1)の外周から垂下し、下端が開口している円筒状のスカート部(F2)と、該スカート部(F2)の内側で篏合する篏合部材(F3)と、を有し、
前記篏合部(F11)は、リップ(F112)と、該リップ(F112)から垂下する中筒(F113)と、を有し、
前記スカート部(F2)は、内部に下側ゴム栓(F211)を有し、該下側ゴム栓(F211)がOリング形状である、プラスチック製キャップを提供する。
本発明において、前記下側ゴム栓(F211)は、上方に向かって凸状であってよい。
本発明において、前記篏合部(F11)は、リップ(F112)において、上面(F115)と、上側ゴム栓(F111)と、下面(F114)と、からなり、前記医療器具との接触面が、前記篏合部(F11)の前記下面(F114)又は前記上面(F115)で少なくとも1箇所は接触してよい。
本発明において、前記篏合部材(F3)は、医薬品容器(A)のリップ(A2)に係合するために、内側に係止爪(F32)を有していてよい。
本発明において、前記篏合部材(F3)の外周面に、複数の係止爪(F31)を有していてよい。
本発明において、前記篏合部材(F3)の外周面に、スカート部(F2)と仮係合するための凹部(F33)を有し、且つ、スカート部の開口部側に凸部(F23)有していてよい。
本発明において、前記凸部(F23)が前記係止爪(F31)を乗り越える力をf3とした場合、前記リップ(A2)の上面から側面を経て下面に至るまでの間に前記係止爪(F32)が乗り越える力f2よりも大きくなっていてよい。
なお、ここに記載された効果は、必ずしもこれらに限定されるものではなく、本明細書中に記載されたいずれかの効果であってもよい。
以下に説明する実施形態は、本発明の代表的な実施形態の一例を示したものであり、これにより本発明の範囲が狭く解釈されることはない。
本発明に係るプラスチック製キャップFは、医療用容器Aに取り付けられ、閉鎖式薬物搬送システム(Closed System Transfer Device:CSTD)に用いられる医療器具と篏合し、CSTDに適用できるキャップである。
ここで、閉鎖式薬物搬送システム(Closed System Transfer Device:CSTD)の定義について説明する。閉鎖式薬物搬送システムは、閉鎖式接続器具(図示せず)と閉鎖式投与ルートの2つを指す場合があるが、本願明細書では、主として、前者の閉鎖式接続器具を指す。
なお、上側ゴム栓F111に対しては、閉鎖式接続器具の針部等を穿刺できる。
前記閉鎖式接続器具であるバイアルアダプタ(図示せず)がハウジングを有する場合、スパイク針を設けた前記バイアルアダプタが、前記篏合部F11に上面から篏合し、前記ハウジング内で前記リップF112の外縁部分を構成する下面F114又は上面F115で少なくとも1箇所は接触する。よって、前記閉鎖式接続器具を前記篏合部F11へ取り付ける際に、複数のバイアルアダプタを必要としない。
篏合部材F3の外周面に設けた凹部F33を、スカート部F2に設けた凸部F23が乗り越える力をf1とし、リップA2を係止爪F32が乗り越える力をf2とした場合、f2>f1の関係となる。凹部F33を、スカート部F2に設けた凸部F23が乗り越える工程を第1係止工程とする。
なお、複数の凸部F116及び複数の凹部F117は、形状を限定するものではなく、縁を有する円環状でもよい。
なお、以下に説明する実施形態は参考であり、その仕様を限定するものではない。
上側ゴム栓F111と下側ゴム栓F211の上下面の全てがゴム素面の場合、前記上側ゴム栓F111の上面はゴム素面で、前記上側ゴム栓F111の下面はプラスチック製フィルムが積層され、シリコーン等の潤滑剤が塗布されていないものが好ましい。
なお、前記上側ゴム栓F111の上面はゴム素面で、仮に上側ゴム栓F111の天面に滑り性が必要な場合には、プラスチック製フィルムを積層できる。前記プラスチック製フィルムとしては、ポリエチレン、ポリプロピレン、フッ素系樹脂等の一般的なプラスチック製フィルムが使用可能である。
また、キャップFと篏合部材F3とは、同一の素材で形成してもよいし、異なる素材で形成してもよいが、高圧蒸気滅菌条件、例えば121℃、20分に耐えられる耐熱性や、劣化、割れ等の強度の問題がなく、放射線滅菌等で滅菌できる素材であればこれらに限定されない。本発明に係るキャップFをプラスチックで形成することで、擦れ合ったり、ぶつかったりしても微粒子が生じることがない。また、キャップFは、例えば射出成形により製造することができるため、形状や構造の自由度が高い。
まず、医薬品容器Aに所望の薬剤を充填した後、医薬品容器Aに半打栓状態でキャップFを保持させる。この半打栓状態では、スカート部F2と篏合部材F3とは凹部F33と係止爪F23を介して仮篏合し、篏合部材F3の内側の凸部F32は医薬品容器AのリップA2に係合する。次いで、凍結乾燥し、凍結乾燥終了後に打栓器を用いる等して、医薬品容器Aを密封する。この際、キャップFの降下に伴い複数の凸部F32がリップA2の外周面に接触しつつ、弾性変形して下降し、凸部F32の先端が、リップA2の外周面を過ぎると、凸部F32が元の状態に戻り、医薬品容器Aに固定される。また、これと同時に、篏合部材F3の上方がスカート部F2の内側に入り、複数の係止爪F31が弾性変形して、スカート部F2と篏合部材F3とが強固に篏合する。次いで、使用者は、CSTDに用いる医療器具を用いて、上面F115側から上側ゴム栓F111を穿刺し、薬剤の移し替えを行う。
A2:リップ
D:カバー
D1:指掛け
F:プラスチック製キャップ
F1:天面部
F11:篏合部
F111:上側ゴム栓
F112:リップ
F113:中筒
F114:下面
F115:上面
F116:凸部
F117:凹部
F2:スカート部
F21:凹部
F23:凸部
F211:下側ゴム栓
F3:篏合部材
F31:係止爪
F32:係止爪
F33:凹部
F35:切り欠き部
F36:リング部材
F37:脚部材
F38:先端部材
F39:隙間
Claims (7)
- 医薬品用容器(A)に取り付けられ、閉鎖式薬物搬送システムに用いられる医療器具と篏合するプラスチック製キャップ(F)であって、
該キャップ(F)は、中央に篏合部(F11)を有する天面部(F1)と、該天面部(F1)の外周から垂下し、下端が開口している円筒状のスカート部(F2)と、該スカート部(F2)の内側で篏合する篏合部材(F3)と、を有し、
前記篏合部(F11)は、リップ(F112)と、該リップ(F112)から垂下する中筒(F113)と、を有し、
前記スカート部(F2)は、内部に下側ゴム栓(F211)を有し、該下側ゴム栓(F211)がOリング形状である、プラスチック製キャップ。 - 前記下側ゴム栓(F211)は、上方に向かって凸状である、請求項1に記載のプラスチック製キャップ。
- 前記篏合部(F11)は、リップ(F112)において、上面(F115)と、上側ゴム栓(F111)と、下面(F114)と、からなり、前記医療器具との接触面が、前記篏合部(F11)の前記下面(F114)又は前記上面(F115)で少なくとも1箇所は接触する、請求項1又は2に記載のプラスチック製キャップ。
- 前記篏合部材(F3)は、医薬品容器(A)のリップ(A2)に係合するために、内側に係止爪(F32)を有する、請求項1から3のいずれか一項に記載のプラスチック製キャップ。
- 前記篏合部材(F3)の外周面に、複数の係止爪(F31)を有する、請求項4に記載のプラスチック製キャップ。
- 前記篏合部材(F3)の外周面に、スカート部(F2)と仮係合するための凹部(F33)を有し、且つ、スカート部(F2)の開口部側に凸部(F23)を有する、請求項5に記載のプラスチック製キャップ。
- 前記凸部(F23)が前記係止爪(F31)を乗り越える力をf3とした場合、前記リップ(A2)の上面から側面を経て下面に至るまでの間に前記係止爪(F32)が乗り越える力f2よりも大きくなる、請求項6に記載のプラスチック製キャップ。
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PCT/JP2020/048647 WO2022137489A1 (ja) | 2020-12-25 | 2020-12-25 | プラスチック製キャップ |
US18/254,823 US20240000660A1 (en) | 2020-12-25 | 2020-12-25 | Plastic cap |
JP2022570934A JP7454294B2 (ja) | 2020-12-25 | 2020-12-25 | プラスチック製キャップ |
EP20966975.3A EP4268786A1 (en) | 2020-12-25 | 2020-12-25 | Plastic cap |
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JP2007282891A (ja) * | 2006-04-18 | 2007-11-01 | Shinko Chemical Co Ltd | バイアル用のキャップ |
JP2011511741A (ja) * | 2008-02-11 | 2011-04-14 | ビオコルプ ルシェルシェ エ デブロプマン | 押圧キャップを有するストッパ装置、およびかかる装置を具備した容器 |
JP2013066748A (ja) * | 2007-04-23 | 2013-04-18 | Plastmed Ltd | 有害薬剤を汚染なく移送するための方法及び装置 |
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JP2007282891A (ja) * | 2006-04-18 | 2007-11-01 | Shinko Chemical Co Ltd | バイアル用のキャップ |
JP2013066748A (ja) * | 2007-04-23 | 2013-04-18 | Plastmed Ltd | 有害薬剤を汚染なく移送するための方法及び装置 |
JP2011511741A (ja) * | 2008-02-11 | 2011-04-14 | ビオコルプ ルシェルシェ エ デブロプマン | 押圧キャップを有するストッパ装置、およびかかる装置を具備した容器 |
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