WO2010082649A1 - Dual-chamber container - Google Patents

Dual-chamber container Download PDF

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Publication number
WO2010082649A1
WO2010082649A1 PCT/JP2010/050480 JP2010050480W WO2010082649A1 WO 2010082649 A1 WO2010082649 A1 WO 2010082649A1 JP 2010050480 W JP2010050480 W JP 2010050480W WO 2010082649 A1 WO2010082649 A1 WO 2010082649A1
Authority
WO
WIPO (PCT)
Prior art keywords
opening
discharge port
bag
drug
drug bag
Prior art date
Application number
PCT/JP2010/050480
Other languages
French (fr)
Japanese (ja)
Inventor
清水馨
村松康宏
Original Assignee
味の素株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 味の素株式会社 filed Critical 味の素株式会社
Priority to JP2010546664A priority Critical patent/JPWO2010082649A1/en
Publication of WO2010082649A1 publication Critical patent/WO2010082649A1/en

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    • 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
    • B65D81/32—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 for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3261—Flexible containers having several compartments
    • B65D81/3266—Flexible containers having several compartments separated by a common rupturable seal, a clip or other removable fastening device
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/17—Component parts, details or accessories; Auxiliary operations
    • B29C45/26—Moulds
    • B29C45/36—Moulds having means for locating or centering cores
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/76—Making non-permanent or releasable joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112—Single lapped joints
    • B29C66/1122—Single lap to lap joints, i.e. overlap joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/345—Progressively making the joint, e.g. starting from the middle
    • B29C66/3452—Making complete joints by combining partial joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/347—General aspects dealing with the joint area or with the area to be joined using particular temperature distributions or gradients; using particular heat distributions or gradients
    • B29C66/3472—General aspects dealing with the joint area or with the area to be joined using particular temperature distributions or gradients; using particular heat distributions or gradients in the plane of the joint, e.g. along the joint line in the plane of the joint or perpendicular to the joint line in the plane of the joint
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43—Joining a relatively small portion of the surface of said articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53—Joining single elements to tubular articles, hollow articles or bars
    • B29C66/532—Joining single elements to the wall of tubular articles, hollow articles or bars
    • B29C66/5326—Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
    • B29C66/53261—Enclosing tubular articles between substantially flat elements
    • B29C66/53262—Enclosing spouts between the walls of bags, e.g. of medical bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
    • B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • B29C66/91411—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • B29C66/9192—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams
    • B29C66/91921—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature
    • 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
    • A61J1/10—Bag-type 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • 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
    • A61J1/202—Separating means
    • A61J1/2024—Separating means having peelable seals
    • 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
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/20—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/21—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being formed by a single dot or dash or by several dots or dashes, i.e. spot joining or spot welding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43—Joining a relatively small portion of the surface of said articles
    • B29C66/431—Joining the articles to themselves
    • B29C66/4312—Joining the articles to themselves for making flat seams in tubular or hollow articles, e.g. transversal seams
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/735—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the extensive physical properties of the parts to be joined
    • B29C66/7352—Thickness, e.g. very thin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
    • B29K2023/04—Polymers of ethylene
    • B29K2023/06—PE, i.e. polyethylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
    • B29K2023/10—Polymers of propylene
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/712—Containers; Packaging elements or accessories, Packages
    • B29L2031/7148—Blood bags, medical bags

Definitions

  • the present invention comprises a drug bag in which an internal cavity is separated by a weak seal portion, each of which forms a plurality of compartments for separately containing and storing a medicine, and the weak seal portion is opened to open each compartment. More specifically, with respect to the multi-chamber container in which the administration is performed through the discharge port that is opened after the medicines are mixed, it is possible to more reliably prevent an erroneous operation in which the administration is performed without opening the weak seal portion. It relates to a multi-chamber container.
  • a discharge port as a plastic molded product is welded to the outer periphery of the drug bag, the discharge port is formed in a cylindrical shape, and the internal cavity opens to one compartment on one end side.
  • a rubber plug is provided at the other end located outside.
  • the weak seal Prior to administration of the drug solution to the patient, the weak seal is peeled open by pressurizing the drug bag from the outside, and the drug bag has a single internal cavity, so the two types of drug solution are mixed and the infusion set is punctured A rubber stopper is punctured with a needle, and a drug solution can be administered from a drug bag. Therefore, in this type of medical mixed-type multi-chamber container, it is indispensable to mix both liquids by opening the weak seal part prior to administration of the chemical solution, and on the other hand, the liquid is discharged without opening the weak seal part. When the rubber stopper is punctured at the outlet, there is a possibility of an erroneous operation in which only the drug solution in the discharge side compartment is administered. As a conventional technique for coping with this problem, there is known a technique in which an opening / closing member that interlocks with the expansion displacement of the medicine bag when the weak seal portion is opened is provided at the discharge port (Patent Document 1).
  • Patent Document 4 there is a type in which a fragile portion is provided in the discharge port, the fragile portion is caused to break by deformation of the drug bag when the weak seal portion is opened, and the discharge port is opened.
  • the opening / closing member opening operation relies only on the expansion deformation of the drug bag for opening the weak seal. Therefore, in relation to the external force necessary for opening the opening / closing member and the force applied to the drug bag for opening the weak seal, the opening / closing member is opened (discharge of the chemical solution from the discharge portion) only by opening the weak seal.
  • the opening / closing member is opened (discharge of the chemical solution from the discharge portion) only by opening the weak seal.
  • the opening / closing member is connected to the discharge port by the fragile portion for the opening operation of the opening / closing member, and the fragile portion is destroyed by relying on the expansion deformation of the drug bag for opening the weak seal, and the opening / closing member is opened.
  • the fragile portion is destroyed by relying on the expansion deformation of the drug bag for opening the weak seal, and the opening / closing member is opened.
  • the present invention has been made in view of the above problems, and an object of the present invention is to more reliably open and close the opening / closing member by opening a weak seal.
  • the welding is formed by a soft film, and is formed by welding the opposing surfaces of the drug bag so as to be separated by pressure so as to separate the internal cavity into a plurality of compartments for storing the respective drugs.
  • a medicine bag provided with a portion, a discharge opening attached to the medicine bag, an opening for opening the inside of the medicine bag inside the discharge opening for infusion, and a plug attached to the discharge opening so as to face the outside of the medicine bag
  • an opening / closing member that normally opens and closes the opening with respect to the inside of the medicine bag, and an opening / closing member that is connected to the discharge port so as to normally close the opening, and an external force for peeling the welded portion from the outside of the medicine bag.
  • a multi-chamber container including a fragile portion to be destroyed and an elastic member that urges the opening / closing member in an opening direction by an elastic force that does not cause destruction of the fragile portion from the inside.
  • the elastic member may be formed by forming an elastic material into a plate shape, and one end may be in contact with the inner surface of the discharge port and the other end may be in contact with the inner surface of the opening / closing member.
  • the welding is formed by a soft film, and is formed by welding the opposing surfaces of the drug bag so as to be separated by pressure so as to separate the internal cavity into a plurality of compartments for storing the respective drugs.
  • a medicine bag provided with a portion, a discharge opening attached to the medicine bag, an opening for opening the inside of the medicine bag inside the discharge opening for infusion, and a plug attached to the discharge opening so as to face the outside of the medicine bag
  • an opening / closing member that normally opens and closes the opening with respect to the inside of the medicine bag, and an opening / closing member that is connected to the discharge port so as to normally close the opening, and an external force for peeling the welded portion from the outside of the medicine bag.
  • a multi-chamber container having a fragile portion to be broken, the fragile portion having a shape having a discontinuous tip.
  • the discontinuity at the tip of the fragile portion can be formed by the intersection of circles having different centers and outer diameters.
  • the welding is formed of a soft film and is formed by welding the opposing surfaces of the drug bag so as to be pressure-separated so as to separate the internal cavity into a plurality of compartments for storing the respective drugs.
  • a medicine bag provided with a portion, a discharge opening attached to the medicine bag, an opening for opening the inside of the medicine bag inside the discharge opening for infusion, and a plug attached to the discharge opening so as to face the outside of the medicine bag
  • an opening / closing member that normally opens and closes the opening with respect to the inside of the medicine bag, and an opening / closing member that is connected to the discharge port so as to normally close the opening, and an external force for peeling the welded portion from the outside of the medicine bag.
  • a fragile portion to be broken wherein the fragile portion is provided with a multi-chamber container whose thickness varies along the longitudinal direction.
  • the fragile portion may have a corrugated cross-sectional shape along the longitudinal direction, or the fragile portion may have a stepped cross-sectional shape with the tip side lowered along the longitudinal direction. it can.
  • a drug bag provided with a welded portion formed by welding the opposite surfaces of the drug bag so as to be pressure-separated so as to separate the internal cavity into a plurality of compartments for storing the respective drugs.
  • Opening / closing part that is attached to the peripheral part is connected to the extension part to the inside of the drug bag via the weak part, and is opened by breaking the weak part by an external force for peeling the weld part from the outside of the drug bag
  • a cylindrical discharge port molding apparatus with a mold that is divided along the longitudinal center line of the discharge port and a mold that is complementary to the discharge port by being located in the central cavity of the mold Of the molten resin that directly opens from the mold through the core end surface to the fragile portion forming site in addition to the molten resin introduction passage from the outer peripheral surface side to the cavity.
  • a molding device with an introduction passage is provided. It is.
  • the welding is formed of a soft film and is formed by welding the opposing surfaces of the drug bag so as to be separated by pressure so as to separate the internal cavity into a plurality of compartments for storing the respective drugs. Is attached to the peripheral portion of the medicine bag provided with a part, connected to the extension part to the inside of the medicine bag via the weak part, and the weak part is destroyed by an external force for peeling the weld part from the outside of the medicine bag.
  • a cylindrical discharge port molding apparatus having an opening / closing portion opened by a mold, and a mold that is divided along a longitudinal center line of the discharge port and a central cavity of the mold And a core that forms a complementary cavity with the discharge port, and the height of the mold part in the molding part of the fragile part in the cavity varies along the longitudinal direction.
  • a molding apparatus is provided.
  • the shape whose height changes along the longitudinal direction is a corrugated cross-sectional shape along the longitudinal direction, or the shape whose height changes along the longitudinal direction is the tip side along the longitudinal direction. It can be made into the step (step) shape which made low, or a taber shape.
  • the elastic member that urges the opening / closing member from the inside in the opening direction with an elastic force that does not cause destruction of the fragile portion, the opening / closing member opening direction when the fragile portion is broken and broken
  • the elastic member can assist the movement, and the opening / closing member can be reliably opened and the medicine can be surely distributed from the medicine bag to the discharge port.
  • the elastic member can be visually observed from the opening when the opening and closing member is opened, it can be used as an indicator that the opening of the medicine bag has been performed reliably by using the coloring of the elastic member together. It can be useful for prevention. Further, if there is a clogging of the opening at the end of the drip, there is a possibility of residual liquid. However, the presence of an elastic member prevents the opening from being clogged at the end of the drip and has an effect of preventing the residual liquid.
  • the fragile portion is molded so that the tip has a discontinuous portion, thereby breaking the fragile portion due to the opening of the opening and closing member at the connection site of the opening and closing member by opening the weak seal portion.
  • the cross-sectional shape of the fragile portion can be changed in the longitudinal direction to locally form a thin portion on the tip side, and the drug bag at the connection site of the opening / closing member by opening the weak seal portion It is possible to reliably start the breakage of the fragile portion due to the expansion of the region starting from the locally thin portion at the tip, and to reliably link the opening operation of the weak seal portion and the opening operation of the on-off valve.
  • the fragile portion forming portion in the cavity is directly passed from the mold through the core end surface.
  • the height of the mold part in the molding part of the fragile part in the cavity changes along the longitudinal direction,
  • the shrinkage of the product due to cooling after molding is concentrated on the thick part, and the thickness of the thin part can be further reduced due to the sink mark, which leads to the opening operation of the outlet when opening the product when it becomes a product. Further certainty of the interlock can be realized.
  • FIG. 1 is a plan view of a multi-chamber container according to the first embodiment of the present invention.
  • 2 is a partial longitudinal sectional view of the multi-chamber container of FIG. 1 (a sectional view taken along the line II-II of FIG. 1).
  • 3 is a cross-sectional view (a cross-sectional view taken along the line III-III in FIG. 1) of the distal end portion of the discharge port in the multi-chamber container of FIG.
  • FIG. 4 is an enlarged view (tab is shown in an open state) of the distal end portion of the discharge port in the multi-chamber container of FIG.
  • FIG. 5 is an enlarged view of the distal end portion of the discharge port in the multi-chamber container of FIG.
  • FIG. 6 is a schematic cross-sectional view of a molding apparatus (mold and core) for molding a discharge port in a multi-chamber container (the tip of the mold is shown along a broken line along line VI-VI in FIG. 7). Is).
  • FIG. 7 is a partial plan view of the molding apparatus shown in FIG.
  • FIG. 8 is a partial cross-sectional view of a molding apparatus according to another embodiment for molding a discharge port in a multi-chamber container.
  • FIG. 9 is a top view of the distal end portion of the discharge port formed by the forming apparatus of FIG.
  • FIG. 10 is a partial cross-sectional view of a molding apparatus of still another embodiment for molding a discharge port in a multi-chamber container.
  • FIG. 11 is a view showing a front end portion of a discharge port formed by the forming apparatus of FIG.
  • the multi-chamber container is composed of a flat drug bag 10 and a discharge port 12.
  • the drug bag 10 is made of a multilayer soft film such as a polyethylene film or a polypropylene film having a thickness of 200 to 400 microns.
  • the outer periphery is sealed by a strong seal portion 14 formed by being pressed at a high temperature such as 150 ° C., which is sufficiently higher than its softening temperature, and forms a rectangular flat bag as a whole.
  • a suspension hole is formed at the upper end (not shown) of the strong seal portion 14, and the drug bag 10 is suspended and held on the drip stand or the like by this suspension hole to perform an infusion operation such as drip or dialysis.
  • a weak seal portion (peelable weld portion) or partition wall 18 extends across the entire width at an intermediate portion in the length direction of the drug bag 10, and the front and back surfaces of the drug bag 10 are welded by the weak seal portion 18, and the inside of the drug bag 10
  • a partition that divides the cavity into a first compartment 20 on the discharge port 12 side and a second compartment 22 on the suspension hole side is configured.
  • the first compartment 20 is filled with the first chemical solution
  • the second compartment 22 is filled with the second chemical solution.
  • the weak seal portion 18 is formed by pressurizing the front and back layers of the polyethylene film forming the drug bag 10 at a low temperature such as 130 ° C., which is slightly higher than its softening temperature.
  • the strong seal portion 14 is left as it is by pressurizing the drug solution in the drug bag 10 from the outside in the compartments 20 and 22 with the respective drug solutions stored in the first compartment 20 and the second compartment 22.
  • the weak seal portion 18 can be peeled and opened (without peeling), and the first chemical liquid and the second chemical liquid can be mixed.
  • the discharge port (port) 12 is a plastic such as polyethylene, polypropylene, polyolefin, etc., having a rigidity and thickness capable of maintaining its form (in order to obtain adhesion by welding with the drug bag 10, the same plastic material as the drug bag 10) Is preferable).
  • the upper and lower plastic soft film layers constituting the strong seal portion 14 on the outer periphery of the drug bag 10 are welded so as to sandwich the outer periphery of the discharge port 12 at the portion 14 ′ of the discharge port 12. It has a structure that is firmly connected.
  • the discharge port 12 has one end (the lower end in FIG. 1) formed with an enlarged diameter portion 12-1, and this enlarged diameter portion 12-1 has an opening 24 formed on the bottom surface.
  • a rubber plug 26 (the plug body of the present invention) is fitted to the portion 24.
  • a puncture needle (not shown) of the infusion set is punctured into the rubber plug 26.
  • the other end of the discharge port 12 (upper end in FIG. 1) forms an extension 12-2 to the drug bag 10, and this extension 12-2 has a rectangular cross-sectional shape as shown in FIG. As shown, the tip 12A is closed.
  • extension portion 12-2 It is preferable to extend the extension portion 12-2 for a long time because the external force for breaking the thin-walled portion, which will be described later, obtained by swelling of the drug bag when the drug bag is opened is preferable, but the difficulty in forming the thin-walled portion is increased.
  • a length of up to 30 mm is preferred.
  • An integrally formed flap or tab 28 (opening / closing member of the present invention) is formed on the upper wall of the extending portion 12-2. The entire outer periphery of the tab 28 is integrally formed and connected to the remaining portion of the upper wall of the extended portion 12-2 of the discharge port 12 via the thin portion 30 (fragile portion of the present invention). Accordingly, the tab 28 normally completely blocks (closes) the communication between the internal cavity (lower compartment 20) of the drug bag 10 and the internal passage 12 'of the discharge port 12.
  • the upper surface of the tab 28 and the lower surface of the extended portion 12-2 of the discharge port 12 facing the tab 28 are firmly welded to the opposed inner surface of the plastic film constituting the drug bag 10.
  • the part of the plastic film welded to the tab 28 is represented by 32
  • the part of the plastic film welded to the extension 12-2 is represented by 34.
  • the welding temperature at the portions 32 and 34 is about the same as the welding of the strong seal portion 14 and about 150 ° C. in the case of polyethylene. Therefore, the tab 28 does not peel off from the medicine bag 10 when the weak bag 18 swells when the weak seal 18 for mixing the medicines in the compartments 20 and 22 is peeled off, and is displaced in conjunction with the expansion displacement of the medicine bag. To do.
  • the thin part 30 is weak, it cannot endure the external force at the time of an expansion displacement, and the thin part 30 is fractured
  • a so-called point seal device can be used as means for welding the tab 28 to the facing surface of the drug bag 10 at the portions 32 and 34.
  • the point seal device includes a pair of welding tools conforming to the shapes of the welding parts 32 and 34, and the upper surface of the tab 28 which is the welding part of the plastic film section and the discharge port 12 constituting the medicine bag by the welding tools and the extension.
  • the plastic film section, the tab 28, and the extending portion 12-2 constituting the medicine bag are point-sealed by the high temperature of the welding tool by sandwiching the lower surface of the protruding portion 12-2.
  • the width of the drug bag internal extension portion 12-2 of the discharge port 12 is preferably about 7.0 mm because if it is too narrow, the welding area becomes too small to obtain the required strength.
  • the lower wall surface of the extended portion 12-2 of the discharge port 12 is provided with a small hole 36, which is useful for wet heat sterilization of the medicine bag 10. is there. That is, in the state where the discharge port 12 (the tab 28 is in a closed state because the thin-walled portion 30 is not broken) and the weak seal portion 18 is formed with respect to the drug bag 10, Fill and seal the filling part. In this state, the welded portion 32 and the collar 34 are not formed, so the inside of the medicine bag (the lower compartment 20) communicates with the internal passage 12 'of the discharge port 12 through the small hole 36.
  • the infusion vapor is introduced into the discharge port 12 through the small holes 36, so that the discharge port 12 can be sterilized under wet heat. become.
  • the welded portion 32 and the flange 34 are formed, and the small hole 36 is closed as shown in FIG.
  • FIG. 5 is an enlarged view of the distal end portion of the upper wall surface of the extended portion 12-2 of the discharge port 12 provided with the tab 28.
  • FIG. The thin portion 30 on the outer periphery of the tab 28 has a rounded tip shape that protrudes toward the inside of the drug bag, but the tip portion 30-1 of the thin portion 30 constitutes a discontinuous portion.
  • the thin-walled portion 30 may be broken depending on the situation at the time of opening. Cases that are unlikely to occur can be envisaged.
  • the tip portion 30-1 By forming the tip portion 30-1 discontinuously, the thin-walled portion 30 causes stress concentration in this portion, and positively starts fracture at the tip portion 30-1 where the moment due to the external force applied to the tab 28 is maximized. Promptly and a reliable breaking operation can be expected. That is, if the tip portion 30-1 breaks, the break can be propagated along the thin-walled portion 30 based on this, and a more reliable opening operation can be expected. In the embodiment of FIG.
  • one side of the distal end portion of the thin portion 30 is constituted by inner and outer concentric circles C1 and C1 ′ on the center O1 on the center line in the width direction of the extending portion 12-2 of the discharge port 12, and the other side.
  • the side is constituted by inner and outer concentric circles C2 and C2 'on the center O2 offset from the center O1. Therefore, a discontinuous portion can be formed in the thin portion 30 at the tip 30-1 where the concentric circles C1 and C1 ′ on one side and the concentric circles C2 and C2 ′ on the other side are joined.
  • a spring 40 (an elastic member of the present invention) is installed in the discharge port 12 to assist the reliable opening of the tab 28 when the drug bag 10 is opened.
  • the spring 40 is composed of a strip of metal or the like (see also FIG. 1 for its shape), one end 40-1 positioned at the enlarged diameter portion 12-1, and the other end 12-2 forming a J-shaped bent portion. is doing. 2 where the tab 28 is in the closed position because the drug bag is not opened, the bent portion 40-2 is bent from the original shape shown by the solid line in FIG. 4 (two-dot line 40-2 in FIG. 4).
  • FIG. 4 shows a state in which the tip of the spring 40 is expanded by an elastic force from the contracted state 12-27 when the tab 28 is closed.
  • the outer end 40-1 is bonded to the bottom wall surface of the discharge port 12 as a mounting method of the spring 40 inside the discharge port 12, but the discharge port is used instead of the bonding method. It is also possible to adopt a method in which a groove is formed in the bottom wall surface of the twelve and a spring 40 is fitted and locked in this groove so as to be attached without bonding.
  • the material of the spring 40 may be a plastic strip, and the color of the spring 40 is conspicuous so that the tab 28 is opened from the color when the tab 28 is opened. It can serve as a means for visually notifying the completion of the drug mixing operation between the two.
  • the tab 28 In normal times (when the weak seal portion is not opened), the tab 28 is in the state of FIG. 2 welded to the opposing inner surface of the drug bag 10 by the point seal portion 32. In this state, the tab 28 is integrated with the discharge port 12 by the thin portion 30, and the internal passage 12 ′ of the discharge port 12 is closed with respect to the internal cavity of the drug bag 10. And even if the rubber plug 26 is punctured with the puncture needle of the infusion set, the medicine cannot be discharged, and this helps to prevent an erroneous operation in which the infusion is performed in a state where the medicine between the compartments 20 and 22 is not mixed. be able to. Further, if the opening 35 is closed at the end of the drip, there is a possibility of residual liquid. However, the presence of the spring 40 prevents the opening 35 from being closed at the end of the drip and prevents the residual liquid. .
  • the weak seal portion 18 is opened by placing the drug bag 10 flat on a desk or the like and pressurizing the infusion solution in the drug bag 10 (which may be either the infusion solution in the compartments 20 or 22) with the palm of the hand. Is called. That is, both layers of the drug bag 10 are separated at the weak seal portion 18 by the pressure of the drug solution applied by pressurization, the compartments 20 and 22 are communicated, and the drug solutions that have been separated and accommodated in the compartments 20 and 22 are mixed. Is done.
  • the weak seal portion 18 is opened, the medicine bag 10 is expanded and deformed as shown in FIG. 4 at the connection portion with the discharge port 12, and the tab 28 firmly connected to the opposite surface of the medicine bag by the point seal portion 32 is formed on the medicine bag.
  • the expansion bias is applied, and the thin portion 30 is broken under the external force, and the tab 28 is rotated as shown in FIG.
  • the passage 12 ′ communicates with the internal cavity of the drug bag 10, the mixed medicine is introduced from the drug bag 10 into the internal passage 12 ′ of the discharge port 12, and a puncture needle of an infusion set is punctured into the rubber stopper 26 to perform infusion. be able to.
  • a puncture needle of an infusion set is punctured into the rubber stopper 26 to perform infusion.
  • FIG. 6 shows a mold for molding the discharge port 12 of FIG. 2 is formed between the upper and lower split molds 41 and 42 and the core 44, and a cavity 46 having a shape complementary to the discharge port 12 of FIG.
  • the split surfaces D of the upper and lower split molds 41 and ridges 42 are positioned along the longitudinal center line of the discharge port 12, and the product can be ejected by separating the split molds after molding.
  • the core 44 is held at one end 44-1 (molded portion of the discharge port 12 on the enlarged diameter portion 12-1 side) and between the upper and lower split molds 41 and 42, but the other end (extension of the discharge port 12)
  • the molded part at the front end side of the portion 12-2 is basically free, that is, the core 44 is cantilevered.
  • a protruding portion 41-1 with respect to the core 44 in the upper split mold 41 is a molding portion of the thin portion 30 on the outer periphery of the tab 28 on the upper surface of the drug bag extension portion 12-2 of the discharge port 12.
  • the small-diameter protrusion 42-1 between the lower mold 42 and the core 44 is a molding part of the sterilization small hole 36 on the lower surface of the medicine bag extension 12-2 of the discharge port.
  • a molten resin injection gate 48 is provided on the upper and lower split molds 41 and 42 as usual. The molten resin from the injection gate 48 is basically injected into the cavity 46 from the side surface, but the core 44 is cantilevered and the path is narrowed at the protruding portion 41-1. Due to the flow resistance, the free end 44-2 side of the core 44 is easily displaced downward in FIG. 6, so that the interval between the protruding portion 41-1 and the core 44 is widened.
  • the auxiliary injection gate 50 is formed so as to open at a portion of the cavity 46 facing the end surface 44 ⁇ / b> A of the core 44.
  • a tapered auxiliary injection hole 54 is formed in the core 44, a reduced diameter portion at one end of the injection hole 54 opens into the upper mold projecting portion 41-1, and a larger diameter portion at the other end is the end surface of the core. The diameter is expanded on the side.
  • the injection hole 54 provided at the tip of the core 44 is directly open to the projecting portion 41-1 which is a molding portion of the thin portion, the molten resin is injected into this portion without resistance. Since the portion is immediately filled, the deflection of the tip of the core 44 during molding is eliminated, and the thickness of the thin portion can be set to a desired value.
  • part corresponding to the injection hole 54 remains after shaping
  • FIG. 8 shows another embodiment of the mold structure for setting the thickness of the thin wall portion as expected in order to surely open the flap when the medicine bag is opened.
  • the surface of the thin part 141-1 of the upper split mold 141 facing the core 144 has an uneven shape.
  • the tip shape of the discharge port 112 formed by this forming apparatus is shown in FIG. 9, and the tab 128 on the upper wall surface of the discharge bag 112 extending portion 112-2 of the discharge port 112 is formed in the drug bag by a thin portion 132 as a fragile portion. It is the same that it is integrally generated in the remaining part of the extension part 112-2.
  • the thin portion 132 has an uneven surface on the top surface.
  • the cooling of the resin after mold molding has a large shrinkage (so-called sink) of the thick part, so that the thick part tensions the thin part, so that the thin part becomes thinner, and therefore due to external force at the time of opening the drug bag
  • the thin portion 132 as the fragile portion can be more reliably destroyed.
  • FIG. 10 shows still another embodiment of the mold structure for setting the thickness of the thin wall portion as desired in order to surely open the flap when the medicine bag is opened.
  • the molding part 241-1 of the thin part in the upper split mold 241 has a step shape with the surface facing the core 244 having a lower height toward the tip.
  • the discharge port 112 molded by this molding apparatus is shown in FIG. 11, and the tab 228 on the upper wall surface of the drug bag extension portion 212-2 of the discharge port 212 is extended by the thin portion 232 as a weak portion. It is the same that it is generated integrally in the remaining part of 212-2.
  • the thin-walled portion 232 has a step shape whose upper surface has a lower height at the tip.

Abstract

A dual-chamber container of two-liquid mixing type, configured so that a discharge opening is opened in response to opening of a partition wall, wherein the discharge opening is adapted to be more reliably opened when the partition wall is opened. A discharge opening (12) of a synthetic resin formed product is provided with a tab (28) which serves as an opening/closing section and is located at the upper wall surface of an extension section (12-2) extended to the inside of a medication bag. The outer periphery of the tab (28) is, together with the remaining portion of the discharge opening (12), formed integrally with a thin-walled section (30) which serves as a weak section. A spring (40) is disposed within the discharge opening (12), and when the discharge opening (12) is in a closed state, the spring (40) is in a contracted state in which the spring applies to the tab (28) elastic force acting in the opening direction. The thin-walled section (30) is broken by inflation of the medication bag occurring when two liquid are mixed, and this opens the tab (28) to cause a medication in the medication bag to be introduced into the discharge opening (12). The elastic force of the spring (40) promotes the breakage of the thin-walled section (30).

Description

複室容器Multi-chamber container
　この発明は、内部空洞が弱シール部によって分離されることにより、それぞれが別個に薬剤を封止収納する複数の隔室を形成した薬剤バッグより成り、弱シール部の開通により夫々の隔室からの薬剤が混合された後に開口される排出口より投与を行うようにした複室容器に関し、より詳しくは、弱シール部の未開通のまま投与が行われてしまうという誤操作をより確実に防止せしめうる複室容器に関する。 The present invention comprises a drug bag in which an internal cavity is separated by a weak seal portion, each of which forms a plurality of compartments for separately containing and storing a medicine, and the weak seal portion is opened to open each compartment. More specifically, with respect to the multi-chamber container in which the administration is performed through the discharge port that is opened after the medicines are mixed, it is possible to more reliably prevent an erroneous operation in which the administration is performed without opening the weak seal portion. It relates to a multi-chamber container.
　輸液用複室容器として、軟質フィルムを素材とする薬剤バッグの対向面を相対的に低温にて溶着して成る弱シール部（隔壁）によってそれぞれ異なった薬液を収容する複数の隔室に分離したものがある。薬剤バッグの外周には、プラスチック成型品としての排出口（ポート）が溶着され、排出口は筒状に形成され、その内部空洞は一端側で一方の隔室に開口しているが、薬剤バッグ外側に位置する他端にはゴム栓が設けられている。患者への薬液の投与に先立って薬剤バッグを外側から加圧することによって弱シール部が剥離開通せしめられ、薬剤バッグの内部空洞は一室となるため２種類の薬液は混合され、輸液セットの穿刺針によりゴム栓を穿刺し、薬剤バッグよりの薬液の投与が可能となる。従って、この種の医療用混合型複室容器においては薬液の投与に先立って弱シール部の開通より両液を混合せしめる作業は必須であり、他方、弱シール部の開通を行わないままで排出口におけるゴム栓の穿刺を行うと、排出口側の隔室における薬液のみが投与されてしまうという誤操作の可能性があった。この問題点に対処する従来技術として、排出口に弱シール部開通時の薬剤バッグの拡開変位に連動する開閉部材を設けたものが公知である（特許文献１）。 As a multi-chamber container for infusion, it was separated into a plurality of compartments containing different drug solutions by weak seal parts (partitions) formed by welding the opposite surfaces of a drug bag made of a soft film at a relatively low temperature. There is something. A discharge port (port) as a plastic molded product is welded to the outer periphery of the drug bag, the discharge port is formed in a cylindrical shape, and the internal cavity opens to one compartment on one end side. A rubber plug is provided at the other end located outside. Prior to administration of the drug solution to the patient, the weak seal is peeled open by pressurizing the drug bag from the outside, and the drug bag has a single internal cavity, so the two types of drug solution are mixed and the infusion set is punctured A rubber stopper is punctured with a needle, and a drug solution can be administered from a drug bag. Therefore, in this type of medical mixed-type multi-chamber container, it is indispensable to mix both liquids by opening the weak seal part prior to administration of the chemical solution, and on the other hand, the liquid is discharged without opening the weak seal part. When the rubber stopper is punctured at the outlet, there is a possibility of an erroneous operation in which only the drug solution in the discharge side compartment is administered. As a conventional technique for coping with this problem, there is known a technique in which an opening / closing member that interlocks with the expansion displacement of the medicine bag when the weak seal portion is opened is provided at the discharge port (Patent Document 1).
　弱シール部が開通されないまま輸液作業がされてしまうという同様な問題の解決のため、排出口の手前において、溶着温度を幾分高くして隔室間の弱シールの開通に遅れて開通される第２の弱シール部を設ける技術も提案されている（特許文献２及び３）。 In order to solve the same problem that the infusion work is done without opening the weak seal part, the welding temperature is raised slightly before the discharge port, and it is opened after the opening of the weak seal between the compartments. A technique for providing a second weak seal portion has also been proposed (Patent Documents 2 and 3).
　また、排出口に脆弱部を設け、弱シール部の開通時の薬剤バッグの変形により脆弱部の破壊を惹起させ、排出口を開口させるものもある（特許文献４）。 Also, there is a type in which a fragile portion is provided in the discharge port, the fragile portion is caused to break by deformation of the drug bag when the weak seal portion is opened, and the discharge port is opened (Patent Document 4).
特開２００６－８７９０４号公報JP 2006-87904 A 特開平９－３２７４９８号公報JP-A-9-327498 特開２００６－５０７９１４号公報JP 2006-507914 A 特開２００６－５０７９１４号公報JP 2006-507914 A
　従来技術は開閉部材の開放動作を弱シール開通のための薬剤バッグの拡開変形にのみ依拠したものである。そのため、開閉部材の開放動作に必要な外部力と弱シール開通のための薬剤バッグに加わる力との関係では弱シール開通だけでは開閉部材の開通（排出部からの薬液の排出）を行わせることができないことがあり得た。 In the prior art, the opening / closing member opening operation relies only on the expansion deformation of the drug bag for opening the weak seal. Therefore, in relation to the external force necessary for opening the opening / closing member and the force applied to the drug bag for opening the weak seal, the opening / closing member is opened (discharge of the chemical solution from the discharge portion) only by opening the weak seal. Could not be.
　また、開閉部材の開放動作のためを開閉部材を排出口に対して脆弱部により連結し、弱シール開通のための薬剤バッグの拡開変形に依拠して脆弱部を破壊し、開閉部材の開通に至らしめているが、排出口の成形時の脆弱部を所期の肉厚にコントロールするのが困難で成形工程上のネックとなっている問題点があった。 In addition, the opening / closing member is connected to the discharge port by the fragile portion for the opening operation of the opening / closing member, and the fragile portion is destroyed by relying on the expansion deformation of the drug bag for opening the weak seal, and the opening / closing member is opened. However, there is a problem that it is difficult to control the fragile part at the time of molding of the discharge port to a desired wall thickness and becomes a bottleneck in the molding process.
　更に、脆弱部の破壊及びこれに伴う開閉部材の開放動作を薬剤バッグの拡開変形に依拠していることから脆弱部の破壊のための外力の大きさが必ずしも所期とならず弱シールの開通時に脆弱部のスムースな破壊が必ずしもいつもスムースに開始されるわけではないという問題点もあった。 Furthermore, since the breakage of the fragile portion and the opening operation of the opening / closing member associated therewith are based on the expansion deformation of the drug bag, the magnitude of the external force for breaking the fragile portion is not necessarily intended and the weak seal There was also a problem that the smooth destruction of the fragile part did not always start smoothly at the time of opening.
　この発明は以上の問題点に鑑みてなされたものであり、弱シール開通による開閉部材の開放をより確実に行わせるようにすることを目的とする。 The present invention has been made in view of the above problems, and an object of the present invention is to more reliably open and close the opening / closing member by opening a weak seal.
　第１の発明によれば、軟質フィルムにて形成され、内部空洞をそれぞれの薬剤の収納のための複数の隔室に分離するべく薬剤バッグの対向面を加圧剥離可能に溶着して成る溶着部を供えた薬剤バッグと、薬剤バッグに装着された排出口と、薬剤バッグ内部を輸液のため排出口内部に開口させる開口部と、薬剤バッグ外部を臨むように排出口に装着される栓体と、通常は前記開口部を薬剤バッグ内部に対し開閉する開閉部材と、開口部を通常において閉鎖するべく開閉部材を排出口に連結し、薬剤バッグ外部からの溶着部の剥離のための外力により破壊される脆弱部と、開閉部材を内側より脆弱部の破壊に至らない弾性力にて開放方向に付勢する弾性部材とを備えた複室容器が提供される。 According to the first aspect of the present invention, the welding is formed by a soft film, and is formed by welding the opposing surfaces of the drug bag so as to be separated by pressure so as to separate the internal cavity into a plurality of compartments for storing the respective drugs. A medicine bag provided with a portion, a discharge opening attached to the medicine bag, an opening for opening the inside of the medicine bag inside the discharge opening for infusion, and a plug attached to the discharge opening so as to face the outside of the medicine bag And an opening / closing member that normally opens and closes the opening with respect to the inside of the medicine bag, and an opening / closing member that is connected to the discharge port so as to normally close the opening, and an external force for peeling the welded portion from the outside of the medicine bag. There is provided a multi-chamber container including a fragile portion to be destroyed and an elastic member that urges the opening / closing member in an opening direction by an elastic force that does not cause destruction of the fragile portion from the inside.
　第１の発明において、弾性部材は弾性材を板状にして形成され、一端は排出口の内面に当接し、他端は開閉部材の内面に当接するようにすることができる。 In the first invention, the elastic member may be formed by forming an elastic material into a plate shape, and one end may be in contact with the inner surface of the discharge port and the other end may be in contact with the inner surface of the opening / closing member.
　第２の発明によれば、軟質フィルムにて形成され、内部空洞をそれぞれの薬剤の収納のための複数の隔室に分離するべく薬剤バッグの対向面を加圧剥離可能に溶着して成る溶着部を供えた薬剤バッグと、薬剤バッグに装着された排出口と、薬剤バッグ内部を輸液のため排出口内部に開口させる開口部と、薬剤バッグ外部を臨むように排出口に装着される栓体と、通常は前記開口部を薬剤バッグ内部に対し開閉する開閉部材と、開口部を通常において閉鎖するべく開閉部材を排出口に連結し、薬剤バッグ外部からの溶着部の剥離のための外力により破壊される脆弱部とを備え、前記脆弱部は先端が不連続部を有した形状をなす複室容器が提供される。 According to the second aspect of the present invention, the welding is formed by a soft film, and is formed by welding the opposing surfaces of the drug bag so as to be separated by pressure so as to separate the internal cavity into a plurality of compartments for storing the respective drugs. A medicine bag provided with a portion, a discharge opening attached to the medicine bag, an opening for opening the inside of the medicine bag inside the discharge opening for infusion, and a plug attached to the discharge opening so as to face the outside of the medicine bag And an opening / closing member that normally opens and closes the opening with respect to the inside of the medicine bag, and an opening / closing member that is connected to the discharge port so as to normally close the opening, and an external force for peeling the welded portion from the outside of the medicine bag. A multi-chamber container having a fragile portion to be broken, the fragile portion having a shape having a discontinuous tip.
　第２の発明において、脆弱部の先端の不連続部は中心及び外径を異にする円の交差により形成することができる。 In the second invention, the discontinuity at the tip of the fragile portion can be formed by the intersection of circles having different centers and outer diameters.
　第３の発明によれば、軟質フィルムにて形成され、内部空洞をそれぞれの薬剤の収納のための複数の隔室に分離するべく薬剤バッグの対向面を加圧剥離可能に溶着して成る溶着部を供えた薬剤バッグと、薬剤バッグに装着された排出口と、薬剤バッグ内部を輸液のため排出口内部に開口させる開口部と、薬剤バッグ外部を臨むように排出口に装着される栓体と、通常は前記開口部を薬剤バッグ内部に対し開閉する開閉部材と、開口部を通常において閉鎖するべく開閉部材を排出口に連結し、薬剤バッグ外部からの溶着部の剥離のための外力により破壊される脆弱部とを備え、前記脆弱部は長手方向に沿って肉厚が変化する複室容器が提供される。 According to the third aspect of the present invention, the welding is formed of a soft film and is formed by welding the opposing surfaces of the drug bag so as to be pressure-separated so as to separate the internal cavity into a plurality of compartments for storing the respective drugs. A medicine bag provided with a portion, a discharge opening attached to the medicine bag, an opening for opening the inside of the medicine bag inside the discharge opening for infusion, and a plug attached to the discharge opening so as to face the outside of the medicine bag And an opening / closing member that normally opens and closes the opening with respect to the inside of the medicine bag, and an opening / closing member that is connected to the discharge port so as to normally close the opening, and an external force for peeling the welded portion from the outside of the medicine bag. And a fragile portion to be broken, wherein the fragile portion is provided with a multi-chamber container whose thickness varies along the longitudinal direction.
　第３の発明において、脆弱部は長手方向に沿って波形の断面形状をなすようにするか又は脆弱部は長手方向に沿って先端側を低くした段状の断面形状をなすようにすることができる。 In the third invention, the fragile portion may have a corrugated cross-sectional shape along the longitudinal direction, or the fragile portion may have a stepped cross-sectional shape with the tip side lowered along the longitudinal direction. it can.
　第４の発明によれば、内部空洞をそれぞれの薬剤の収納のための複数の隔室に分離するべく薬剤バッグの対向面を加圧剥離可能に溶着して成る溶着部を供えた薬剤バッグの周縁部に装着され、薬剤バッグ内部への延出部に脆弱部を介して連接されかつ薬剤バッグ外部からの溶着部の剥離のための外力により脆弱部が破壊されることにより開口される開閉部を備えた筒状の排出口の成形装置であって、排出口の長手方向中心線に沿って分割される金型と金型の中心空洞に位置することにより金型とで排出口と相補的なキャビティを形成する中子とを備えてなり、キャビティへの外周面側からの溶融樹脂の導入通路に加え金型から中子端面を介してキャビティにおける脆弱部形成部位に直接開口する溶融樹脂の導入通路とを備えた成形装置が提供される。 According to the fourth aspect of the present invention, there is provided a drug bag provided with a welded portion formed by welding the opposite surfaces of the drug bag so as to be pressure-separated so as to separate the internal cavity into a plurality of compartments for storing the respective drugs. Opening / closing part that is attached to the peripheral part, is connected to the extension part to the inside of the drug bag via the weak part, and is opened by breaking the weak part by an external force for peeling the weld part from the outside of the drug bag A cylindrical discharge port molding apparatus with a mold that is divided along the longitudinal center line of the discharge port and a mold that is complementary to the discharge port by being located in the central cavity of the mold Of the molten resin that directly opens from the mold through the core end surface to the fragile portion forming site in addition to the molten resin introduction passage from the outer peripheral surface side to the cavity. A molding device with an introduction passage is provided. It is.
　第５の発明によれば、軟質フィルムにて形成され、内部空洞をそれぞれの薬剤の収納のための複数の隔室に分離するべく薬剤バッグの対向面を加圧剥離可能に溶着して成る溶着部を供えた薬剤バッグの周縁部に装着され、薬剤バッグ内部への延出部に脆弱部を介して連接されかつ薬剤バッグ外部からの溶着部の剥離のための外力により脆弱部が破壊されることにより開口される開閉部を備えた筒状の排出口の成形装置であって、排出口の長手方向中心線に沿って分割される金型と金型の中心空洞に位置することにより金型とで排出口と相補的なキャビティを形成する中子とを備えてなり、キャビティにおける脆弱部の成形部位における金型の部位は中子に向けた高さが長手方向に沿って変化している成形装置が提供される。 According to the fifth aspect of the present invention, the welding is formed of a soft film and is formed by welding the opposing surfaces of the drug bag so as to be separated by pressure so as to separate the internal cavity into a plurality of compartments for storing the respective drugs. Is attached to the peripheral portion of the medicine bag provided with a part, connected to the extension part to the inside of the medicine bag via the weak part, and the weak part is destroyed by an external force for peeling the weld part from the outside of the medicine bag. A cylindrical discharge port molding apparatus having an opening / closing portion opened by a mold, and a mold that is divided along a longitudinal center line of the discharge port and a central cavity of the mold And a core that forms a complementary cavity with the discharge port, and the height of the mold part in the molding part of the fragile part in the cavity varies along the longitudinal direction. A molding apparatus is provided.
　第５の発明において、高さが長手方向に沿って変化する形状は長手方向に沿って波形の断面形状とするか又は高さが長手方向に沿って変化する形状は長手方向に沿って先端側を低くしたステップ（段）形状若しくはテーバ形状とすることができる。 In the fifth invention, the shape whose height changes along the longitudinal direction is a corrugated cross-sectional shape along the longitudinal direction, or the shape whose height changes along the longitudinal direction is the tip side along the longitudinal direction. It can be made into the step (step) shape which made low, or a taber shape.
　第１の発明によれば、開閉部材を内側より脆弱部の破壊に至らない弾性力にて開放方向に付勢する弾性部材を設けることにより、脆弱部の破壊及び破壊時における開閉部材の開放方向の動きを弾性部材により助勢することができ、開閉部材の確実な開放及び薬剤バッグから排出口へ向けての薬剤の確実な流通を行わしめることができる。また、開閉部材の開放時に開口部から弾性部材を目視することができるため弾性部材の着色を併用すること等で薬剤バッグの開通が確実に行われたことの指標たらしめることができ、誤操作の防止に役立てることができる。また、点滴終了時、開口部の閉塞があるとすると残液の可能性があるが、弾性部材があることで、点滴終了時に開口部が閉塞されず、残液防止効果がある。 According to the first aspect of the present invention, by providing the elastic member that urges the opening / closing member from the inside in the opening direction with an elastic force that does not cause destruction of the fragile portion, the opening / closing member opening direction when the fragile portion is broken and broken The elastic member can assist the movement, and the opening / closing member can be reliably opened and the medicine can be surely distributed from the medicine bag to the discharge port. In addition, since the elastic member can be visually observed from the opening when the opening and closing member is opened, it can be used as an indicator that the opening of the medicine bag has been performed reliably by using the coloring of the elastic member together. It can be useful for prevention. Further, if there is a clogging of the opening at the end of the drip, there is a possibility of residual liquid. However, the presence of an elastic member prevents the opening from being clogged at the end of the drip and has an effect of preventing the residual liquid.
　第２の発明によれば、脆弱部を先端が不連続部を有するように成形することで、弱シール部の開通による開閉部材の接続部位での薬剤バッグの拡開による脆弱部の破壊を先端の不連続部を基点に確実に開始させることができ、弱シール部の開通操作と開閉弁の開放動作とを確実に連動させることができる。 According to the second invention, the fragile portion is molded so that the tip has a discontinuous portion, thereby breaking the fragile portion due to the opening of the opening and closing member at the connection site of the opening and closing member by opening the weak seal portion. Thus, it is possible to reliably start the discontinuous portion as a base point, and to reliably link the opening operation of the weak seal portion and the opening operation of the on-off valve.
　第３の発明によれば、脆弱部の断面形状を長手方向に変化させ、先端側において局所的に薄い部分を形成することができ、弱シール部の開通による開閉部材の接続部位での薬剤バッグの拡開による脆弱部の破壊を先端の局所的薄肉部を基点に確実に開始させることができ、弱シール部の開通操作と開閉弁の開放動作とを確実に連動させることができる。 According to the third invention, the cross-sectional shape of the fragile portion can be changed in the longitudinal direction to locally form a thin portion on the tip side, and the drug bag at the connection site of the opening / closing member by opening the weak seal portion It is possible to reliably start the breakage of the fragile portion due to the expansion of the region starting from the locally thin portion at the tip, and to reliably link the opening operation of the weak seal portion and the opening operation of the on-off valve.
　第４の発明によれば、排出口の成形用の成形装置において、キャビティへの外周面側からの溶融樹脂の導入通路に加え金型から中子端面を介してキャビティにおける脆弱部形成部位に直接開口する溶融樹脂の導入通路を備えることにより成形時に排出口における脆弱部形成部位に直接樹脂を充填することができ、成形工程中の中子先端の変位を防止することができ、脆弱部が中子のブレにより肉厚になりすぎることを防止し、所期の肉厚に確実に成形することができる。 According to the fourth invention, in the molding apparatus for molding the discharge port, in addition to the molten resin introduction passage from the outer peripheral surface side to the cavity, the fragile portion forming portion in the cavity is directly passed from the mold through the core end surface. By providing an opening for introducing molten resin, it is possible to directly fill the fragile portion forming site at the discharge port during molding, prevent displacement of the core tip during the molding process, and It is possible to prevent the thickness from becoming too thick due to the blurring of the child, and to reliably form the desired thickness.
　第５の発明によれば、排出口の成形用の成形装置において、キャビティにおける脆弱部の成形部位における金型の部位は中子に向けた高さが長手方向に沿って変化しているため、成形後の冷却による製品の収縮を肉厚部に集中させ、これによるヒケにより薄肉部の肉厚をより縮減させることができ、製品となったときの開通操作時の排出口の開口動作への連動の一層の確実化を実現することができる。 According to the fifth invention, in the molding apparatus for molding the discharge port, the height of the mold part in the molding part of the fragile part in the cavity changes along the longitudinal direction, The shrinkage of the product due to cooling after molding is concentrated on the thick part, and the thickness of the thin part can be further reduced due to the sink mark, which leads to the opening operation of the outlet when opening the product when it becomes a product. Further certainty of the interlock can be realized.
図１はこの発明の第１の実施形態における複室容器の平面図である。FIG. 1 is a plan view of a multi-chamber container according to the first embodiment of the present invention. 図２は図１の複室容器の部分的縦断面図（図１のII－II線に沿って現される矢視断面図）である。2 is a partial longitudinal sectional view of the multi-chamber container of FIG. 1 (a sectional view taken along the line II-II of FIG. 1). 図３は図１の複室容器における排出口の先端部分の横断面図（図１のIII－III線に沿って現される矢視断面図）である。3 is a cross-sectional view (a cross-sectional view taken along the line III-III in FIG. 1) of the distal end portion of the discharge port in the multi-chamber container of FIG. 図４は図２の複室容器における排出口の先端部分の拡大図（タブは開放状態にて示す）である。FIG. 4 is an enlarged view (tab is shown in an open state) of the distal end portion of the discharge port in the multi-chamber container of FIG. 図５は図１の複室容器における排出口の先端部分の拡大図である。FIG. 5 is an enlarged view of the distal end portion of the discharge port in the multi-chamber container of FIG. 図６は複室容器における排出口を成形するための成形装置（金型及び中子）の概略的断面図（金型先端部は図７のVI-VI線に沿った破断線に沿って表されている）である。6 is a schematic cross-sectional view of a molding apparatus (mold and core) for molding a discharge port in a multi-chamber container (the tip of the mold is shown along a broken line along line VI-VI in FIG. 7). Is). 図７は図の成形装置の部分的平面図である。FIG. 7 is a partial plan view of the molding apparatus shown in FIG. 図８は複室容器における排出口を成形するための別実施形態の成形装置部分的断面図である。FIG. 8 is a partial cross-sectional view of a molding apparatus according to another embodiment for molding a discharge port in a multi-chamber container. 図９は図８の成形装置により成形される排出口の先端部分の上面図である。FIG. 9 is a top view of the distal end portion of the discharge port formed by the forming apparatus of FIG. 図１０は複室容器における排出口を成形するための更に別実施形態の成形装置部分的断面図である。FIG. 10 is a partial cross-sectional view of a molding apparatus of still another embodiment for molding a discharge port in a multi-chamber container. 図１１は図１０の成形装置により成形される排出口の先端部分を示す図である。FIG. 11 is a view showing a front end portion of a discharge port formed by the forming apparatus of FIG.
　図１及び図２において、複室容器は平坦状の薬剤バッグ１０と排出口１２とから構成される。薬剤バッグ１０は厚さ200～400ミクロンといったポリエチレンフィルムやポリプロピレンフィルムなどの多層軟質フィルムを素材とする。ポリエチレンフィルムの場合に外周はその軟化温度より十分高い１５０℃といった高温にて加圧されることにより形成された強シール部１４により封止され、全体として矩形の平坦な袋状をなしている。強シール部１４の図示しない上端に懸垂孔が穿設され、この懸垂孔によって薬剤バッグ１０を点滴台などに吊り下げ保持し、点滴や透析などの輸液作業を行うようになっている。 1 and 2, the multi-chamber container is composed of a flat drug bag 10 and a discharge port 12. The drug bag 10 is made of a multilayer soft film such as a polyethylene film or a polypropylene film having a thickness of 200 to 400 microns. In the case of a polyethylene film, the outer periphery is sealed by a strong seal portion 14 formed by being pressed at a high temperature such as 150 ° C., which is sufficiently higher than its softening temperature, and forms a rectangular flat bag as a whole. A suspension hole is formed at the upper end (not shown) of the strong seal portion 14, and the drug bag 10 is suspended and held on the drip stand or the like by this suspension hole to perform an infusion operation such as drip or dialysis.
　薬剤バッグ１０の長さ方向における中間部位において全幅にわたって弱シール部（剥離可能溶着部）又は隔壁１８が延びており、弱シール部１８によって薬剤バッグ１０の表裏面が溶着され、薬剤バッグ１０の内部空洞を排出口１２側の第１隔室２０と懸垂孔側の第２隔室２２とに区画する隔壁が構成される。第１隔室２０に第１薬液が充填され、第２隔室２２に第２薬液が充填される。弱シール部１８は薬剤バッグ１０を形成するポリエチレンフィルムの表裏層をその軟化温度よりやや高い１３０℃といった低温にて加圧することにより形成される。そのため、第１隔室２０と第２隔室２２にそれぞれの薬液を収容した状態で隔室20, 22の部位において薬剤バッグ１０における薬液を外側より加圧することにより、強シール部１４はそのままに（剥離させることなく）、弱シール部１８を剥離・開通せしめ、第１薬液と第２薬液との混合を行うことができる。 A weak seal portion (peelable weld portion) or partition wall 18 extends across the entire width at an intermediate portion in the length direction of the drug bag 10, and the front and back surfaces of the drug bag 10 are welded by the weak seal portion 18, and the inside of the drug bag 10 A partition that divides the cavity into a first compartment 20 on the discharge port 12 side and a second compartment 22 on the suspension hole side is configured. The first compartment 20 is filled with the first chemical solution, and the second compartment 22 is filled with the second chemical solution. The weak seal portion 18 is formed by pressurizing the front and back layers of the polyethylene film forming the drug bag 10 at a low temperature such as 130 ° C., which is slightly higher than its softening temperature. Therefore, the strong seal portion 14 is left as it is by pressurizing the drug solution in the drug bag 10 from the outside in the compartments 20 and 22 with the respective drug solutions stored in the first compartment 20 and the second compartment 22. The weak seal portion 18 can be peeled and opened (without peeling), and the first chemical liquid and the second chemical liquid can be mixed.
　排出口（ポート）１２はその形態を維持しうる剛性を有した肉厚を有したポリエチレン若しくはポリプロピレン，ポリオレフィンなどのプラスチック（薬剤バッグ１０との溶着による密着性を得るため薬剤バッグ１０と同種プラスチック素材とすることが好ましい）の成形品である。薬剤バッグ１０の外周における強シール部１４を構成する上下のプラスチック軟質フィルム層は排出口１２の部位１４´では排出口１２の外周を挟むように溶着され、これにより、排出口１２は薬剤バッグ１０と強固に連接された構造となっている。 The discharge port (port) 12 is a plastic such as polyethylene, polypropylene, polyolefin, etc., having a rigidity and thickness capable of maintaining its form (in order to obtain adhesion by welding with the drug bag 10, the same plastic material as the drug bag 10) Is preferable). The upper and lower plastic soft film layers constituting the strong seal portion 14 on the outer periphery of the drug bag 10 are welded so as to sandwich the outer periphery of the discharge port 12 at the portion 14 ′ of the discharge port 12. It has a structure that is firmly connected.
　図２に示すように、排出口１２は一端（図１の下端）は拡径部12-1を形成し、この拡径部12-1は底面に開口部２４を形成しており、この開口部２４にゴム栓２６（この発明の栓体）が嵌着されている。周知のように、輸液時において、ゴム栓２６に輸液セットの穿刺針（図示せず）が穿刺される。排出口１２の他端（図１の上端）は薬剤バッグ１０への延出部12-2を形成し、この延出部12-2は図３に示すように矩形断面形状をなし、図１に示すように先端１２Ａは閉じている。延出部12-2を長く延ばすことにより薬剤バッグ開通時の薬剤バッグの膨れにより得られる後述薄肉部の破壊のための外力が大きくなるため好ましいが、薄肉部の成形の難度が高くなるため20～30mmといった長さが好ましい。延出部12-2の上壁に一体成形のフラップ若しくはタブ２８（この発明の開閉部材）を形成している。タブ２８の全外周は薄肉部３０（この発明の脆弱部）を介して排出口１２の延出部12-2の上壁の残余の部位に一体に成形・連結されている。従って、タブ２８は通常時は薬剤バッグ１０の内部空洞（下側隔室２０）と排出口１２の内部通路１２´との連通を完全阻止（閉塞）している。 As shown in FIG. 2, the discharge port 12 has one end (the lower end in FIG. 1) formed with an enlarged diameter portion 12-1, and this enlarged diameter portion 12-1 has an opening 24 formed on the bottom surface. A rubber plug 26 (the plug body of the present invention) is fitted to the portion 24. As is well known, at the time of infusion, a puncture needle (not shown) of the infusion set is punctured into the rubber plug 26. The other end of the discharge port 12 (upper end in FIG. 1) forms an extension 12-2 to the drug bag 10, and this extension 12-2 has a rectangular cross-sectional shape as shown in FIG. As shown, the tip 12A is closed. It is preferable to extend the extension portion 12-2 for a long time because the external force for breaking the thin-walled portion, which will be described later, obtained by swelling of the drug bag when the drug bag is opened is preferable, but the difficulty in forming the thin-walled portion is increased. A length of up to 30 mm is preferred. An integrally formed flap or tab 28 (opening / closing member of the present invention) is formed on the upper wall of the extending portion 12-2. The entire outer periphery of the tab 28 is integrally formed and connected to the remaining portion of the upper wall of the extended portion 12-2 of the discharge port 12 via the thin portion 30 (fragile portion of the present invention). Accordingly, the tab 28 normally completely blocks (closes) the communication between the internal cavity (lower compartment 20) of the drug bag 10 and the internal passage 12 'of the discharge port 12.
　図２に示すように、タブ２８の上面及びタブ２８に対向した排出口１２の延出部12-2の下面は、薬剤バッグ１０を構成するプラスチックフィルムの対向内面に強固に溶着される。タブ２８に溶着されるプラスチックフィルムの部位を３２にて表し、延出部12-2に溶着されるプラスチックフィルムの部位を３４にて表す。部位32, 34での溶着温度としては、強シール部１４の溶着と同程度の温度で、ポリエチレンの場合は１５０℃程度である。そのため、隔室20, 22の薬剤の混合のための弱シール部１８の剥離時における薬剤バッグの膨れの際にタブ２８は薬剤バッグ１０から剥離することなく薬剤バッグの拡開変位と連動し変位する。そして、薄肉部３０が脆弱であるため拡開変位時の外力に耐えられず薄肉部３０は少なくとも一部（大抵は先端部）で破断され、タブ２８は図２の閉鎖状態から図４に示すように外力が弱いため破壊し難い根元の部位を中心に回動され、排出口１２の延出部12-2の上面に、排出口１２の内部通路１２´を薬剤バッグ内部に連通せしめる開口部３５が形成される。部位32, 34おける薬剤バッグ１０の対向面に対するタブ２８の溶着手段としては、所謂ポイントシール装置を採用することができる。即ち、ポイントシール装置は溶着部32, 34の形状に準じた一対の溶着具を備え、溶着具によって薬剤バッグを構成するプラスチックフィルム切片と排出口１２の被溶着部であるタブ２８の上面及び延出部12-2の下面とを挟着し、溶着具の高温によって薬剤バッグを構成するプラスチックフィルム切片とタブ２８及び延出部12-2とがポイントシールされる。また、排出口１２の薬剤バッグ内部延出部12-2の幅としては、狭すぎると溶着面積が小さくなりすぎてしまい所要の強度が得られないため7.0mm程度が好ましい。 As shown in FIG. 2, the upper surface of the tab 28 and the lower surface of the extended portion 12-2 of the discharge port 12 facing the tab 28 are firmly welded to the opposed inner surface of the plastic film constituting the drug bag 10. The part of the plastic film welded to the tab 28 is represented by 32, and the part of the plastic film welded to the extension 12-2 is represented by 34. The welding temperature at the portions 32 and 34 is about the same as the welding of the strong seal portion 14 and about 150 ° C. in the case of polyethylene. Therefore, the tab 28 does not peel off from the medicine bag 10 when the weak bag 18 swells when the weak seal 18 for mixing the medicines in the compartments 20 and 22 is peeled off, and is displaced in conjunction with the expansion displacement of the medicine bag. To do. And since the thin part 30 is weak, it cannot endure the external force at the time of an expansion displacement, and the thin part 30 is fractured | ruptured by at least one part (usually front-end | tip part), and the tab 28 is shown in FIG. 4 from the closed state of FIG. In this way, an opening that allows the internal passage 12 ′ of the discharge port 12 to communicate with the inside of the medicine bag is rotated around the base portion that is difficult to break because the external force is weak. 35 is formed. A so-called point seal device can be used as means for welding the tab 28 to the facing surface of the drug bag 10 at the portions 32 and 34. That is, the point seal device includes a pair of welding tools conforming to the shapes of the welding parts 32 and 34, and the upper surface of the tab 28 which is the welding part of the plastic film section and the discharge port 12 constituting the medicine bag by the welding tools and the extension. The plastic film section, the tab 28, and the extending portion 12-2 constituting the medicine bag are point-sealed by the high temperature of the welding tool by sandwiching the lower surface of the protruding portion 12-2. Further, the width of the drug bag internal extension portion 12-2 of the discharge port 12 is preferably about 7.0 mm because if it is too narrow, the welding area becomes too small to obtain the required strength.
　図２及び図４に示すように排出口１２の延出部12-2の下壁面は小孔３６を穿設しており、この小孔３６は薬剤バッグ１０の湿熱殺菌に役立てるためのものである。即ち、薬剤バッグ１０に対し排出口１２（タブ２８は薄肉部３０が未破壊のため閉鎖状態にある）を装着しかつ弱シール部１８を形成した状態で、隔室20, 22への薬液の充填を行い充填部のシールを行う。この状態では溶着部32, 34は未形成であるため、薬剤バッグ内部（下側隔室２０）は小孔３６を介して排出口１２の内部通路１２´に連通している。そのため、バッグ全体を内部滅菌のための所定温度に加熱することで輸液蒸気が小孔３６を介して排出口１２の内部に導入されるため排出口１２を湿熱下で滅菌できる、という好都合なことになる。滅菌後に溶着部32, 34が形成され、小孔３６は図２のように閉鎖された状態となる。 As shown in FIGS. 2 and 4, the lower wall surface of the extended portion 12-2 of the discharge port 12 is provided with a small hole 36, which is useful for wet heat sterilization of the medicine bag 10. is there. That is, in the state where the discharge port 12 (the tab 28 is in a closed state because the thin-walled portion 30 is not broken) and the weak seal portion 18 is formed with respect to the drug bag 10, Fill and seal the filling part. In this state, the welded portion 32 and the collar 34 are not formed, so the inside of the medicine bag (the lower compartment 20) communicates with the internal passage 12 'of the discharge port 12 through the small hole 36. Therefore, by heating the entire bag to a predetermined temperature for internal sterilization, the infusion vapor is introduced into the discharge port 12 through the small holes 36, so that the discharge port 12 can be sterilized under wet heat. become. After the sterilization, the welded portion 32 and the flange 34 are formed, and the small hole 36 is closed as shown in FIG.
　図５はタブ２８を設けた排出口１２の延出部12-2の上壁面の先端部分の拡大図である。タブ２８の外周の薄肉部３０は薬剤バッグ内部側に突出して丸み帯びた先端形状をなすが、薄肉部３０は先端部位30-1が不連続部位を構成している。薬剤バッグ１０の開通時には薬剤バッグ１０における排出口１２との接続部位は図４に示すように拡開変形し、このときタブ２８に加わる外力と比較して薄肉部３０は弱くなるような設定である。しかしながら、タブ２８の拡開は薬剤バッグ開通時における排出口１２の取付部付近での薬剤バッグの変形（膨れ）にのみに依拠しているため、開通時の状況によっては薄肉部３０の破壊が起こり難い場合が想定しうる。薄肉部３０は先端部位30-1を不連続に構成することで、この部位に応力集中を起こさせ、タブ２８に加わる外力によるモーメントが最大となる先端部位30-1での破断の開始を積極的に促し、確実な破断動作を期待することができる。即ち、先端部位30-1の破断が起こればこれを基点に薄肉部３０に沿って破壊を伝播させることができ、より確実な開放動作を期することができる。図５の実施形態においては、薄肉部３０の先端部の一方側は排出口１２の延出部12-2の幅方向中心線上の中心Ｏ１上の内外の同心円C1, C1'により構成し、他方側は中心Ｏ１からオフセットした中心Ｏ２上の内外の同心円C2, C2'により構成している。そのため、一方側の同心円C1, C1'と他方側の同心円C2, C2'とが接合する先端部30-1において薄肉部３０に不連続部を形成することができる。 FIG. 5 is an enlarged view of the distal end portion of the upper wall surface of the extended portion 12-2 of the discharge port 12 provided with the tab 28. FIG. The thin portion 30 on the outer periphery of the tab 28 has a rounded tip shape that protrudes toward the inside of the drug bag, but the tip portion 30-1 of the thin portion 30 constitutes a discontinuous portion. When the drug bag 10 is opened, the connecting portion of the drug bag 10 with the discharge port 12 is expanded and deformed as shown in FIG. 4, and the thin portion 30 is weakened as compared with the external force applied to the tab 28 at this time. is there. However, since the expansion of the tab 28 depends only on the deformation (swelling) of the drug bag in the vicinity of the attachment portion of the discharge port 12 when the drug bag is opened, the thin-walled portion 30 may be broken depending on the situation at the time of opening. Cases that are unlikely to occur can be envisaged. By forming the tip portion 30-1 discontinuously, the thin-walled portion 30 causes stress concentration in this portion, and positively starts fracture at the tip portion 30-1 where the moment due to the external force applied to the tab 28 is maximized. Promptly and a reliable breaking operation can be expected. That is, if the tip portion 30-1 breaks, the break can be propagated along the thin-walled portion 30 based on this, and a more reliable opening operation can be expected. In the embodiment of FIG. 5, one side of the distal end portion of the thin portion 30 is constituted by inner and outer concentric circles C1 and C1 ′ on the center O1 on the center line in the width direction of the extending portion 12-2 of the discharge port 12, and the other side. The side is constituted by inner and outer concentric circles C2 and C2 'on the center O2 offset from the center O1. Therefore, a discontinuous portion can be formed in the thin portion 30 at the tip 30-1 where the concentric circles C1 and C1 ′ on one side and the concentric circles C2 and C2 ′ on the other side are joined.
　図２において、スプリング４０（この発明の弾性部材）は薬剤バッグ１０の開通時のタブ２８の確実な開通を助成するため排出口１２内に設置される。スプリング４０は金属等の帯片（その形状については図１も参照）により構成され、一端40-1は拡径部12-1に位置され、他端12-2はＪ形の屈曲部を形成している。薬剤バッグ未開通のためタブ２８が閉鎖位置にある図２の状態において屈曲部40-2は図４の実線にて示す本来の形状より撓められた状態（図４の二点差線40-2'）にあり、その撓みに基づく弾性力はタブ２８を開放方向に付勢するが、この付勢力は薄肉部３０の破裂強度未満であり、タブ２８は閉鎖状態に保持される。薬剤バッグの開通時にこの付勢力は薬剤バッグ開通時の排出口１２の取付部付近の薬剤バッグ拡開による開放方向の力に上乗せされるため、タブ２８が開放方向に動くように助成され、タブ２８をしてより確実に開放位置せしめるのに役立てることができる。図４はスプリング４０の先端部がタブ２８の閉鎖時の収縮状態12-27から弾性力により拡開した状態を示す。排出口１２内部へのスプリング４０の装着方式としては図２の実施形態では外側端部40-1を排出口１２の底壁面に接着することを想定しているが、接着方式の代わりに排出口１２の底壁面に溝を形成し、この溝にスプリング４０を嵌着係止することにより非接着にて取り付ける方式も採用しうる。また、スプリング４０の素材としてはプラスチック帯片でもよく、目立ちやすい色彩とすることによりタブ２８開放時にその色からタブ２８が開けられたこと、延いては弱シール部１８の開通による隔室20, 22間の薬剤混合操作の完了を視覚的に了知せしめる手段として役立たせることができる。 2, a spring 40 (an elastic member of the present invention) is installed in the discharge port 12 to assist the reliable opening of the tab 28 when the drug bag 10 is opened. The spring 40 is composed of a strip of metal or the like (see also FIG. 1 for its shape), one end 40-1 positioned at the enlarged diameter portion 12-1, and the other end 12-2 forming a J-shaped bent portion. is doing. 2 where the tab 28 is in the closed position because the drug bag is not opened, the bent portion 40-2 is bent from the original shape shown by the solid line in FIG. 4 (two-dot line 40-2 in FIG. 4). The elastic force based on the bending force urges the tab 28 in the opening direction, but this urging force is less than the burst strength of the thin-walled portion 30, and the tab 28 is held in the closed state. When the drug bag is opened, this urging force is added to the force in the opening direction due to the expansion of the drug bag in the vicinity of the attachment portion of the discharge port 12 when the drug bag is opened, so that the tab 28 is supported to move in the opening direction. 28 can be used to make the opening position more reliable. FIG. 4 shows a state in which the tip of the spring 40 is expanded by an elastic force from the contracted state 12-27 when the tab 28 is closed. In the embodiment of FIG. 2, it is assumed that the outer end 40-1 is bonded to the bottom wall surface of the discharge port 12 as a mounting method of the spring 40 inside the discharge port 12, but the discharge port is used instead of the bonding method. It is also possible to adopt a method in which a groove is formed in the bottom wall surface of the twelve and a spring 40 is fitted and locked in this groove so as to be attached without bonding. The material of the spring 40 may be a plastic strip, and the color of the spring 40 is conspicuous so that the tab 28 is opened from the color when the tab 28 is opened. It can serve as a means for visually notifying the completion of the drug mixing operation between the two.
　次に、この発明の薬剤バッグによる輸液作業について説明すると、通常時（弱シール部未開通時）はタブ２８はポイントシール部３２により薬剤バッグ１０の対向内面に溶着された図２の状態にあり、この状態においてタブ２８は薄肉部３０によって排出口１２に一体化されており、排出口１２の内部通路１２´は薬剤バッグ１０の内部空洞に対し閉塞されている。そして、輸液セットの穿刺針をゴム栓２６に穿刺しても薬剤の排出は行い得ず、隔室20, 22間の薬剤の未混合状態で輸液が行われてしまうという誤操作の未然防止に役立てることができる。また、点滴終了時、開口部３５が閉塞してしまうとすると、残液の可能性があるが、スプリング４０があることで、点滴終了時に開口部３５が閉塞されず、残液が防止される。 Next, the infusion operation using the drug bag of the present invention will be described. In normal times (when the weak seal portion is not opened), the tab 28 is in the state of FIG. 2 welded to the opposing inner surface of the drug bag 10 by the point seal portion 32. In this state, the tab 28 is integrated with the discharge port 12 by the thin portion 30, and the internal passage 12 ′ of the discharge port 12 is closed with respect to the internal cavity of the drug bag 10. And even if the rubber plug 26 is punctured with the puncture needle of the infusion set, the medicine cannot be discharged, and this helps to prevent an erroneous operation in which the infusion is performed in a state where the medicine between the compartments 20 and 22 is not mixed. be able to. Further, if the opening 35 is closed at the end of the drip, there is a possibility of residual liquid. However, the presence of the spring 40 prevents the opening 35 from being closed at the end of the drip and prevents the residual liquid. .
　弱シール部１８の開通は、薬剤バッグ１０を机などの上に平坦に載置し、薬剤バッグ１０内の輸液（隔室20, 22のいずれの輸液でも良い）を手のひらで加圧することにより行われる。即ち、加圧により加わる薬液の圧力により弱シール部１８において薬剤バッグ１０の両層が分離し、隔室20, 22は連通され、それまで隔室20, 22に分離収容されていた薬液は混合される。弱シール部１８の開通時に薬剤バッグ１０は排出口１２との接続部において図４のように拡開変形され、ポイントシール部３２により薬剤バッグ対向面に強固に接続されたタブ２８は薬剤バッグの拡開変位に連動して拡開付勢され、その外力下で薄肉部３０は破壊され、タブ２８は図４に示すように回動され、開口部３５を形成するため、排出口１２の内部通路１２´と薬剤バッグ１０の内部空洞とが連通され、混合薬剤が薬剤バッグ１０より排出口１２の内部通路１２´に導入され、ゴム栓２６に輸液セットの穿刺針を穿刺し、輸液を行うことができる。尚、スプリングに着色を行うことで、開通状態の目視による確認に役立たせることができる。 The weak seal portion 18 is opened by placing the drug bag 10 flat on a desk or the like and pressurizing the infusion solution in the drug bag 10 (which may be either the infusion solution in the compartments 20 or 22) with the palm of the hand. Is called. That is, both layers of the drug bag 10 are separated at the weak seal portion 18 by the pressure of the drug solution applied by pressurization, the compartments 20 and 22 are communicated, and the drug solutions that have been separated and accommodated in the compartments 20 and 22 are mixed. Is done. When the weak seal portion 18 is opened, the medicine bag 10 is expanded and deformed as shown in FIG. 4 at the connection portion with the discharge port 12, and the tab 28 firmly connected to the opposite surface of the medicine bag by the point seal portion 32 is formed on the medicine bag. In response to the expansion displacement, the expansion bias is applied, and the thin portion 30 is broken under the external force, and the tab 28 is rotated as shown in FIG. The passage 12 ′ communicates with the internal cavity of the drug bag 10, the mixed medicine is introduced from the drug bag 10 into the internal passage 12 ′ of the discharge port 12, and a puncture needle of an infusion set is punctured into the rubber stopper 26 to perform infusion. be able to. In addition, by coloring the spring, it can be used for visual confirmation of the open state.
　以下は、合成樹脂成形品としてのこの発明の排出口１２の成形工程について説明すると、図６は図２の排出口１２の成形のための金型であって、上下の割型41, 42と、中子（コアピン）４４とからなり、上下の割型41, 42と、中子４４との間に図２の排出口１２と相補的な形状のキャビティ４６が形成される。上下の割型41, 42の割面Ｄは排出口１２の長手方向中心線に沿って位置され、成形後の割型の分離により製品のエジェクトが可能となっている。中子４４は一端44-1（排出口１２の拡径部12-1側の成形部位）においてと上下の割型41, 42間に保持されているが、他端（排出口１２の延出部12-2の先端側の成形部位）では基本的にフリーであり、即ち、中子４４は片持支持となっている。上側の割型４１における中子４４に対する突出部位41-1は排出口１２の薬剤バッグ内延出部12-2の上面におけるタブ２８の外周の薄肉部３０の成形部である。また、下型４２と中子４４との間の小径突起部42-1は排出口の薬剤バッグ内延出部12-2の下面の滅菌用小孔３６の成形部位である。中子４４を上下の割型41, 42に通常のように溶融樹脂の注入ゲート４８が設けられている。注入ゲート４８からの溶融樹脂はキャビティ４６に基本的に側面から注入されるが、中子４４が片持であり、また、突出部位41-1の部位において経路が狭まっているため、樹脂の大きな流れ抵抗により、中子４４のフリー端部44-2の側が図６の下方に変位しやすいために突出部位41-1と中子４４との間隔が広がり、突出部位41-1は中子４４との間における成形部である排出口１２の薄肉部３０の肉厚が所期の値より大きくなってしまい勝ちである。この場合、薄肉部３０の破壊強度は設定値より大きくなり、薬剤バッグ開通時に確実な破壊が行われ難くなる。この問題に対処のため、図６に示すように補助の注入ゲート５０がキャビティ４６における中子４４の端面４４Ａに対する対向部位に開口するように形成される。そして、中子４４にはテーパ状の補助注入孔５４が形成され、注入孔５４の一端の縮径部は上型の突出部位41-1に開口し、他端の拡径部は中子端面側で拡径する。中子４４の先端に設けた注入孔５４が薄肉部の成形部である突出部位41-1に直接開口しているため、この部位への溶融樹脂の注入が抵抗なく行われるため、樹脂がこの部位を即座に埋めるため成形中の中子４４の先端の振れが解消され、薄肉部の肉厚を所期の値に設定することが可能となる。尚、成形後において注入孔５４に応じた成形部位が残るが、型抜き時にこの成形部位は縮径部側で引き千切られることになる。 The molding process of the discharge port 12 of the present invention as a synthetic resin molded product will be described below. FIG. 6 shows a mold for molding the discharge port 12 of FIG. 2 is formed between the upper and lower split molds 41 and 42 and the core 44, and a cavity 46 having a shape complementary to the discharge port 12 of FIG. The split surfaces D of the upper and lower split molds 41 and ridges 42 are positioned along the longitudinal center line of the discharge port 12, and the product can be ejected by separating the split molds after molding. The core 44 is held at one end 44-1 (molded portion of the discharge port 12 on the enlarged diameter portion 12-1 side) and between the upper and lower split molds 41 and 42, but the other end (extension of the discharge port 12) The molded part at the front end side of the portion 12-2 is basically free, that is, the core 44 is cantilevered. A protruding portion 41-1 with respect to the core 44 in the upper split mold 41 is a molding portion of the thin portion 30 on the outer periphery of the tab 28 on the upper surface of the drug bag extension portion 12-2 of the discharge port 12. Further, the small-diameter protrusion 42-1 between the lower mold 42 and the core 44 is a molding part of the sterilization small hole 36 on the lower surface of the medicine bag extension 12-2 of the discharge port. A molten resin injection gate 48 is provided on the upper and lower split molds 41 and 42 as usual. The molten resin from the injection gate 48 is basically injected into the cavity 46 from the side surface, but the core 44 is cantilevered and the path is narrowed at the protruding portion 41-1. Due to the flow resistance, the free end 44-2 side of the core 44 is easily displaced downward in FIG. 6, so that the interval between the protruding portion 41-1 and the core 44 is widened. The thickness of the thin portion 30 of the discharge port 12, which is the molded portion between the two, becomes larger than the expected value. In this case, the breaking strength of the thin-walled portion 30 becomes larger than the set value, and it is difficult to reliably break when the medicine bag is opened. In order to cope with this problem, as shown in FIG. 6, the auxiliary injection gate 50 is formed so as to open at a portion of the cavity 46 facing the end surface 44 </ b> A of the core 44. A tapered auxiliary injection hole 54 is formed in the core 44, a reduced diameter portion at one end of the injection hole 54 opens into the upper mold projecting portion 41-1, and a larger diameter portion at the other end is the end surface of the core. The diameter is expanded on the side. Since the injection hole 54 provided at the tip of the core 44 is directly open to the projecting portion 41-1 which is a molding portion of the thin portion, the molten resin is injected into this portion without resistance. Since the portion is immediately filled, the deflection of the tip of the core 44 during molding is eliminated, and the thickness of the thin portion can be set to a desired value. In addition, although the shaping | molding site | part corresponding to the injection hole 54 remains after shaping | molding, this shaping | molding site | part will be shredded by the reduced diameter part side at the time of die cutting.
　図８は薬剤バッグ開通時のフラップの開放を確実に行うべく薄肉部の肉厚を所期に設定するための金型の構造の別実施形態を示す。この実施形態では上部割型１４１における薄肉部の成形部141-1は中子１４４との対向面が凹凸形状をなしている。この成形装置により成形される排出口１１２の先端形状を図９に示し、排出口１１２の薬剤バッグ内延出部112-2における上壁面のタブ１２８は脆弱部としての薄肉部１３２により薬剤バッグ内延出部112-2の残余の部位に一体生成されていることは同様である。しかしながら、薄肉部１３２は上面が凹凸面を呈している。型成形後の樹脂の冷却は肉厚部の収縮（所謂ヒケ）が大きくそのため、肉厚の部分が肉薄の部分を緊張するため、肉薄の部分はより薄くなり、そのため薬剤バッグ開通時の外力による脆弱部としての薄肉部１３２の破壊をより確実に行わせることができる。 FIG. 8 shows another embodiment of the mold structure for setting the thickness of the thin wall portion as expected in order to surely open the flap when the medicine bag is opened. In this embodiment, the surface of the thin part 141-1 of the upper split mold 141 facing the core 144 has an uneven shape. The tip shape of the discharge port 112 formed by this forming apparatus is shown in FIG. 9, and the tab 128 on the upper wall surface of the discharge bag 112 extending portion 112-2 of the discharge port 112 is formed in the drug bag by a thin portion 132 as a fragile portion. It is the same that it is integrally generated in the remaining part of the extension part 112-2. However, the thin portion 132 has an uneven surface on the top surface. The cooling of the resin after mold molding has a large shrinkage (so-called sink) of the thick part, so that the thick part tensions the thin part, so that the thin part becomes thinner, and therefore due to external force at the time of opening the drug bag The thin portion 132 as the fragile portion can be more reliably destroyed.
　図１０は薬剤バッグ開通時のフラップの開放を確実に行うべく薄肉部の肉厚を所期に設定するための金型の構造の更に別の実施形態を示す。この実施形態では上部割型２４１における薄肉部の成形部241-1は中子２４４との対向面が先端程高さが低いステップ（段）形状をなしている。この成形装置により成形される排出口１１２を図１１に示し、排出口２１２の薬剤バッグ内延出部212-2における上壁面のタブ２２８は脆弱部としての薄肉部２３２により薬剤バッグ内延出部212-2の残余の部位に一体生成されていることは同様である。しかしながら、薄肉部２３２は上面が先端程高さが低いステップ（段）形状を呈している。これにより成形時、肉厚部より樹脂が流れ込むため、先端側に圧力が掛かり難くなり、中子の振れが小さくなり、先端の薄肉部の安定成形が可能となる。そのため薬剤バッグ開通時の外力による脆弱部としての薄肉部２３２の破壊を先端部より確実に進行させることができる。ステップ形状の代わりに先端程低いテーパ形状としても同様な効果が得られる。 FIG. 10 shows still another embodiment of the mold structure for setting the thickness of the thin wall portion as desired in order to surely open the flap when the medicine bag is opened. In this embodiment, the molding part 241-1 of the thin part in the upper split mold 241 has a step shape with the surface facing the core 244 having a lower height toward the tip. The discharge port 112 molded by this molding apparatus is shown in FIG. 11, and the tab 228 on the upper wall surface of the drug bag extension portion 212-2 of the discharge port 212 is extended by the thin portion 232 as a weak portion. It is the same that it is generated integrally in the remaining part of 212-2. However, the thin-walled portion 232 has a step shape whose upper surface has a lower height at the tip. As a result, since resin flows from the thick part during molding, it becomes difficult to apply pressure to the tip side, the deflection of the core is reduced, and the thin part at the tip can be stably molded. Therefore, the destruction of the thin portion 232 as the fragile portion due to the external force when the medicine bag is opened can be surely advanced from the tip portion. A similar effect can be obtained by using a tapered shape with a lower tip instead of the step shape.
１０…薬剤バッグ
１２…排出口
12-2…排出口の薬剤バッグへの延出部
１４…強シール部
１８…弱シール部
20, 22…隔室
２８…タブ（この発明の開閉部材）
３０…薄肉部３０（この発明の脆弱部）
30-1…薄肉部先端の不連続部
32, 34…溶着部（ポイントシール）
３５…タブ破壊後の排出口の開口部
３６…滅菌用小孔
４０…スプリング
41, 42…排出口の成形用の上下の割型
４４…中子（コアピン）
４６…キャビティ
４８…溶融樹脂の注入ゲート
５０…補助の注入ゲート 10 ... Drug bag 12 ... Discharge port
12-2 ... Extension part 14 to the medicine bag of the discharge port ... Strong seal part 18 ... Weak seal part
20, 22 ... compartment 28 ... tab (opening and closing member of the present invention)
30 ... Thin portion 30 (fragile portion of the present invention)
30-1… Discontinuous part at the tip of thin part
32, 34… welded part (point seal)
35 ... Opening opening 36 after tab destruction ... Small hole 40 for sterilization ... Spring
41, 42… Upper and lower split molds 44 for forming discharge ports… Core (core pin)
46 ... Cavity 48 ... Molten resin injection gate 50 ... Auxiliary injection gate

Claims (11)

  1. 　軟質フィルムにて形成され、内部空洞をそれぞれの薬剤の収納のための複数の隔室に分離するべく薬剤バッグの対向面を加圧剥離可能に溶着して成る溶着部を供えた薬剤バッグと、薬剤バッグに装着された排出口と、薬剤バッグ内部を輸液のため排出口内部に開口させる開口部と、薬剤バッグ外部を臨むように排出口に装着される栓体と、通常は前記開口部を薬剤バッグ内部に対し開閉する開閉部材と、開口部を通常において閉鎖するべく開閉部材を排出口に連結し、薬剤バッグ外部からの溶着部の剥離のための外力により破壊される脆弱部と、開閉部材を内側より脆弱部の破壊に至らない弾性力にて開放方向に付勢する弾性部材とを備えた複室容器。 A drug bag formed of a soft film and provided with a welding portion formed by welding the opposing surfaces of the drug bag so as to be capable of being pressure-separated so as to separate the internal cavity into a plurality of compartments for storing respective drugs; A discharge port mounted on the drug bag, an opening for opening the inside of the drug bag inside the discharge port for infusion, a plug mounted on the discharge port so as to face the outside of the drug bag, and usually the opening An opening / closing member that opens and closes the inside of the medicine bag, an opening / closing member that is connected to the discharge port to normally close the opening, and a fragile part that is broken by an external force for peeling the welded part from the outside of the medicine bag, and opening and closing A multi-chamber container provided with an elastic member that urges the member in the opening direction by an elastic force that does not cause destruction of the fragile portion from the inside.
  2. 　請求項１に記載の発明において弾性部材は弾性材を板状にして形成され、一端は排出口の内面に当接し、他端は開閉部材の内面に当接する複室容器。 The multi-chamber container according to claim 1, wherein the elastic member is formed of an elastic material in a plate shape, one end is in contact with the inner surface of the discharge port, and the other end is in contact with the inner surface of the opening / closing member.
  3. 　軟質フィルムにて形成され、内部空洞をそれぞれの薬剤の収納のための複数の隔室に分離するべく薬剤バッグの対向面を加圧剥離可能に溶着して成る溶着部を供えた薬剤バッグと、薬剤バッグに装着された排出口と、薬剤バッグ内部を輸液のため排出口内部に開口させる開口部と、薬剤バッグ外部を臨むように排出口に装着される栓体と、通常は前記開口部を薬剤バッグ内部に対し開閉する開閉部材と、開口部を通常において閉鎖するべく開閉部材を排出口に連結し、薬剤バッグ外部からの溶着部の剥離のための外力により破壊される脆弱部とを備え、前記脆弱部は先端が不連続部を有した形状をなす複室容器。 A drug bag formed of a soft film and provided with a welding portion formed by welding the opposing surfaces of the drug bag so as to be capable of being pressure-separated so as to separate the internal cavity into a plurality of compartments for storing respective drugs; A discharge port mounted on the drug bag, an opening for opening the inside of the drug bag inside the discharge port for infusion, a plug mounted on the discharge port so as to face the outside of the drug bag, and usually the opening An opening / closing member that opens and closes with respect to the inside of the medicine bag, and an opening / closing member that is connected to the discharge port so as to normally close the opening, and a fragile portion that is destroyed by an external force for peeling the welded portion from the outside of the medicine bag. The fragile portion is a multi-chamber container having a shape with a discontinuous tip.
  4. 　請求項３に記載の発明において、脆弱部の先端の不連続部は中心及び外径を異にする円の交差により形成ざれる複室容器。 4. The multi-chamber container according to claim 3, wherein the discontinuous portion at the tip of the fragile portion is formed by the intersection of circles having different centers and outer diameters.
  5. 　軟質フィルムにて形成され、内部空洞をそれぞれの薬剤の収納のための複数の隔室に分離するべく薬剤バッグの対向面を加圧剥離可能に溶着して成る溶着部を供えた薬剤バッグと、薬剤バッグに装着された排出口と、薬剤バッグ内部を輸液のため排出口内部に開口させる開口部と、薬剤バッグ外部を臨むように排出口に装着される栓体と、通常は前記開口部を薬剤バッグ内部に対し開閉する開閉部材と、開口部を通常において閉鎖するべく開閉部材を排出口に連結し、薬剤バッグ外部からの溶着部の剥離のための外力により破壊される脆弱部とを備え、前記脆弱部は長手方向に沿って肉厚が変化する複室容器。 A drug bag formed of a soft film and provided with a welding portion formed by welding the opposing surfaces of the drug bag so as to be capable of being pressure-separated so as to separate the internal cavity into a plurality of compartments for storing respective drugs; A discharge port mounted on the drug bag, an opening for opening the inside of the drug bag inside the discharge port for infusion, a plug mounted on the discharge port so as to face the outside of the drug bag, and usually the opening An opening / closing member that opens and closes with respect to the inside of the medicine bag, and an opening / closing member that is connected to the discharge port so as to normally close the opening, and a fragile portion that is destroyed by an external force for peeling the welded portion from the outside of the medicine bag. The fragile portion is a multi-chamber container whose thickness varies along the longitudinal direction.
  6. 　請求項５に記載の発明において脆弱部は長手方向に沿って波形の断面形状をなす複室容器。 In the invention according to claim 5, the fragile portion has a corrugated cross-sectional shape along the longitudinal direction.
  7. 　請求項５に記載の発明において脆弱部は長手方向に沿って先端側を低くした段状若しくはテーパ状の断面形状をなす複室容器。 In the invention according to claim 5, the fragile portion is a multi-chamber container having a stepped or tapered cross-sectional shape with the tip side lowered along the longitudinal direction.
  8. 　軟質フィルムにて形成され、内部空洞をそれぞれの薬剤の収納のための複数の隔室に分離するべく薬剤バッグの対向面を加圧剥離可能に溶着して成る溶着部を供えた薬剤バッグの周縁部に装着され、薬剤バッグ内部への延出部に脆弱部を介して連接されかつ薬剤バッグ外部からの溶着部の剥離のための外力により脆弱部が破壊されることにより開口される開閉部を備えた筒状の排出口の成形装置であって、排出口の長手方向中心線に沿って分割される金型と金型の中心空洞に位置することにより金型とで排出口と相補的なキャビティを形成する中子とを備えてなり、キャビティへの外周面側からの溶融樹脂の導入通路に加え金型から中子端面を介してキャビティにおける脆弱部形成部位に直接開口する溶融樹脂の導入通路とを備えた成形装置。 Periphery of a drug bag formed of a soft film and provided with a welded portion formed by welding the opposite surfaces of the drug bag so as to be separated by pressure so as to separate the internal cavity into a plurality of compartments for storing each drug. An opening / closing part that is attached to the part, connected to the extension part to the inside of the medicine bag via the weak part, and opened by breaking the weak part by an external force for peeling the weld part from the outside of the medicine bag A cylindrical discharge port molding apparatus provided with a mold divided along a longitudinal center line of the discharge port and a mold complementary to the discharge port by being located in the central cavity of the mold Introducing molten resin that directly opens from the mold through the core end surface to the fragile part forming site in addition to the molten resin introduction passage from the outer peripheral surface side to the cavity. Molding equipment with a passage .
  9. 　軟質フィルムにて形成され、内部空洞をそれぞれの薬剤の収納のための複数の隔室に分離するべく薬剤バッグの対向面を加圧剥離可能に溶着して成る溶着部を供えた薬剤バッグの周縁部に装着され、薬剤バッグ内部への延出部に脆弱部を介して連接されかつ薬剤バッグ外部からの溶着部の剥離のための外力により脆弱部が破壊されることにより開口される開閉部を備えた筒状の排出口の成形装置であって、排出口の長手方向中心線に沿って分割される金型と金型の中心空洞に位置することにより金型とで排出口と相補的なキャビティを形成する中子とを備えてなり、キャビティにおける脆弱部の成形部位における金型の部位は中子に向けた高さが長手方向に沿って変化している成形装置。 Periphery of a drug bag formed of a soft film and provided with a welded portion formed by welding the opposite surfaces of the drug bag so as to be separated by pressure so as to separate the internal cavity into a plurality of compartments for storing each drug. An opening / closing part that is attached to the part, connected to the extension part to the inside of the medicine bag via the weak part, and opened by breaking the weak part by an external force for peeling the weld part from the outside of the medicine bag A cylindrical discharge port molding apparatus provided with a mold divided along a longitudinal center line of the discharge port and a mold complementary to the discharge port by being located in the central cavity of the mold A molding apparatus comprising a core that forms a cavity, and a height of the mold part in the molding part of the fragile portion in the cavity varies along the longitudinal direction.
  10. 　請求項９に記載の発明において高さが長手方向に沿って変化する形状は長手方向に沿って波形の断面形状である成形装置。 10. The molding apparatus according to claim 9, wherein the shape whose height varies along the longitudinal direction is a corrugated cross-sectional shape along the longitudinal direction.
  11. 　請求項９に記載の発明において高さが長手方向に沿って変化する形状は長手方向に沿って先端側を低くした段状若しくはテーパ状の断面形状である成形装置。 10. The molding apparatus according to claim 9, wherein the shape whose height changes along the longitudinal direction is a stepped or tapered cross-sectional shape with the tip side lowered along the longitudinal direction.
PCT/JP2010/050480 2009-01-19 2010-01-18 Dual-chamber container WO2010082649A1 (en)

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Publication number Priority date Publication date Assignee Title
JP2012135433A (en) * 2010-12-27 2012-07-19 Terumo Corp Hollow body for medical container, discharge port for medical container, drug container for medical container, and medical container
JP2017060542A (en) * 2015-09-24 2017-03-30 株式会社大協精工 Stopper with port
JP2017192584A (en) * 2016-04-21 2017-10-26 大和製罐株式会社 Syringe container
WO2018064263A1 (en) * 2016-09-29 2018-04-05 Cryovac, Inc. Multi-chamber iv bag and method of production thereof

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JP2006087904A (en) * 2004-08-25 2006-04-06 Terumo Corp Cylindrical body for medical container, drug container for medical container, discharge port for medical container and medical container
WO2008136452A1 (en) * 2007-04-27 2008-11-13 Ajinomoto Co., Inc. Double-cell container

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JP2006087904A (en) * 2004-08-25 2006-04-06 Terumo Corp Cylindrical body for medical container, drug container for medical container, discharge port for medical container and medical container
WO2008136452A1 (en) * 2007-04-27 2008-11-13 Ajinomoto Co., Inc. Double-cell container

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012135433A (en) * 2010-12-27 2012-07-19 Terumo Corp Hollow body for medical container, discharge port for medical container, drug container for medical container, and medical container
JP2017060542A (en) * 2015-09-24 2017-03-30 株式会社大協精工 Stopper with port
JP2017192584A (en) * 2016-04-21 2017-10-26 大和製罐株式会社 Syringe container
WO2017183713A1 (en) * 2016-04-21 2017-10-26 大和製罐株式会社 Syringe container
WO2018064263A1 (en) * 2016-09-29 2018-04-05 Cryovac, Inc. Multi-chamber iv bag and method of production thereof

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TW201040083A (en) 2010-11-16

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