WO2014104281A1 - Contenant multi-compartiment - Google Patents

Contenant multi-compartiment Download PDF

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Publication number
WO2014104281A1
WO2014104281A1 PCT/JP2013/085066 JP2013085066W WO2014104281A1 WO 2014104281 A1 WO2014104281 A1 WO 2014104281A1 JP 2013085066 W JP2013085066 W JP 2013085066W WO 2014104281 A1 WO2014104281 A1 WO 2014104281A1
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WO
WIPO (PCT)
Prior art keywords
container
compartment
bag
sealing
inner container
Prior art date
Application number
PCT/JP2013/085066
Other languages
English (en)
Japanese (ja)
Inventor
野上藤男
宮嶋千春
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 CN201380063856.7A priority Critical patent/CN104837465B/zh
Priority to KR1020157019002A priority patent/KR101817492B1/ko
Publication of WO2014104281A1 publication Critical patent/WO2014104281A1/fr

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    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • 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

Definitions

  • This invention is configured as a bag (bag-like body) made of a flexible (soft) synthetic resin film for use in infusion, etc., and various types of drugs are individually stored by partitioning the inside with a peelable welded portion.
  • the present invention relates to a multi-chamber container and a sealing method thereof.
  • each multi-chamber container is composed of a container body formed of a synthetic resin film and a small container (inner container) housed inside the container body. Is weakly sealed at the opposing surface, and this weakly sealed portion is firmly attached (strongly sealed) to the opposing surface of the outer container body.
  • the small container is arranged between the compartments and extends in the width direction, and the upper and lower sides of the small container are configured as sealing portions (weak seals), and the opening portion is the outer container. Is welded (strongly sealed) to the opposite surface. Therefore, when the container is expanded due to external pressure for communication with the compartment, the opening of the small container is peeled and opened, and the medicine contained in the inner container is mixed with the medicine contained in the compartment and discharged from the outlet. To be done.
  • the weak seal portion (the external pressure value for opening is larger than this weak seal portion) ( The second partition) is provided close to the discharge port, and the chemical solution is mixed by opening the first partition, and then the second partition is opened by further pressurization to mix the drugs between the compartments.
  • Patent Document 4 a method in which the discharge is performed after the occurrence of the occurrence of the problem.
  • Patent Documents 1-3 it is assumed that the weak seal portion is opened by pressurizing the chemical liquid portion in the compartment on the side away from the discharge port. Therefore, the inner container is the compartment on the pressurized side. By this, opening of the compartment and opening of the inner container can be interlocked.
  • a precautionary statement regarding the necessity of opening work by applying pressure at a predetermined site (a compartment on the side away from the discharge port) prior to infusion is provided on the surface of the product so that the infusion is not performed without being opened. It is printed.
  • the compartment on the discharge port side (lower side) opens directly to the discharge port. Therefore, if the infusion set is punctured without opening, the infusion solution from the lower compartment can be removed. In this case, the infusion may be performed without mixing the infusion solution or introducing a small amount of medicine.
  • Patent Document 4 in addition to the first partition between the compartments, a second partition is provided in front of the discharge port, and the external force for peeling and opening the second partition is made larger than that of the first partition.
  • the order is the first partition and then the second partition, it does not include the inner container, and does not present any solution to the above-described problems in the infusion bag including the inner container.
  • the present invention has been made in view of the above problems in a multi-chamber container containing an inner container.
  • the first opening of the first partition between the compartments, and the opening of the second partition before the discharge port after that are performed.
  • the purpose is to ensure that the opening sequence can be ensured and that the inner container is also reliably opened, so that the possibility of erroneous operations such as infusion with only some drugs can be reliably eliminated.
  • the multi-chamber container of the present invention includes an outer container formed in a bag shape from a flexible film, a discharge port fixed to the outer peripheral portion of the outer container, for discharging a drug, and a side away from the discharge port.
  • a first partition that partitions the inside of the outer container and can be opened by an external force applied to the outer container, and an outer container that partitions the interior of the outer container on the side close to the discharge port and has an external force that opens the first partition.
  • a second partition that can be opened by an external force to the first partition, a first compartment that is formed inside the outer container on the side away from the discharge port of the first partition, and that contains the first liquid medicine, and the first partition Formed in the outer container between the second partition and the second partition, formed in the outer container between the second compartment containing the second liquid medicine, the second compartment and the discharge port, and discharged.
  • a discharge control chamber that communicates with the outlet and a flexible film.
  • the inner container is fixed to the opposing inner surface of the outer container along the compartment and the proximity side, and is provided with an external force applying part that applies an external force for opening the sealing part of the inner container.
  • the flexible film constituting the inner container can be thermoformed with a recess for forming a cavity for containing the medicine.
  • the second partition wall has a sealing portion of the inner container on the side close to the second compartment and a second side end portion of the sealing portion of the inner container on the side close to the second compartment.
  • the separation chamber and the discharge control chamber can be connected to each other so as to be separated.
  • the fixing part of the inner container to the opposing inner surface of the outer container in the external force applying part is on the second compartment side from the sealing part of the inner container. Can be extended somewhat. Further, it is possible to prevent the fixing portion from substantially covering the sealing portion of the inner container.
  • auxiliary external force imparting portion that locally fixes the side of the inner container sealing portion that is separated from the second compartment to the opposing surface of the outer container.
  • a pair of auxiliary external force applying portions can be installed so as to sandwich the discharge port.
  • the present invention also provides a sealing method for a multi-chamber container as described above, in which an outer container whose outer periphery is unsealed on the side separated from the compartment is prepared, and on the other hand, an auxiliary drug is accommodated inside and the outer periphery is sealed by a sealing portion.
  • Prepare a sealed inner container insert the inner container into the outer container from the unsealed part, and weld the sealed part of the inner container to the opposing inner surface of the outer container on the side close to the compartment and the external force applying part
  • the present invention provides a sealing method for a multi-chamber container.
  • the flexible film which comprises an inner side container is provided with the inner layer of the welding temperature higher than the welding temperature for external force provision part formation, and the flexible film which comprises an inner side container is with a compartment.
  • the center part in the width direction of the flattened bag-like film sheet is center-sealed so that it can be peeled off and opened by cutting both closed ends, and the center seal is opened via the sheet opening part.
  • a liquid injection nozzle is inserted so as to follow, and a cavity is formed by forming a bottom seal with side seals and cross seals so as to be peelable from the sheet by a seal mold, and after feeding the sheet, the cavity A predetermined amount of drug is injected from the liquid injection nozzle, and the top side of the cavity after the drug injection is closed by a cross seal.
  • the steps of defining the cavity closed at the bottom by the side seal and the cross seal, injecting the drug, and closing the top by the cross seal are repeated, and the sheet is It is composed of a chain of filling parts.
  • the protective film is detachably attached to the sheet surface that is the outermost surface when the inner container is used, and the protective film is peeled off when being attached to the outer container.
  • the cavity into which the chemical solution is injected can be a cavity whose shape is fixed by pressure-molding the film at the outer diameter portion (injection body) of the injection nozzle with a seal mold at the time of sealing.
  • An external force is applied by arranging the inner container inside the outer container between the second compartment and the discharge control chamber, and fixing the inner container to the opposing inner surface of the outer container along the second compartment and the adjacent side.
  • the external pressure for opening the second partition is larger than that of the first partition, so that the second container is opened in conjunction with the opening of the second partition following the opening of the first partition.
  • the sealing portion can be opened, and the medicine stored in the first and second compartments can be reliably mixed with the medicine stored in the inner container and introduced into the discharge port.
  • the opening side of the inner container by an external force is not impaired by allowing the second partition wall to form a side closer to the second compartment in the sealing portion of the inner container, and the outer container is limited.
  • the internal space can be used effectively, while the outer surface of the inner container can be kept open to the discharge control chamber on substantially the entire surface (other than the welded portion), and a small amount accommodated in the discharge control chamber during sterilization.
  • the inner container and the discharge control chamber can be sterilized with the water vapor for injection.
  • the outer force due to the expansion between the films constituting the outer container at the time of opening is sealed. It can be transmitted efficiently to the stop and can be efficiently opened.
  • the sealing portion of the inner container is locally fixed to the opposing inner surface of the outer container by the auxiliary external force applying section on the side away from the second compartment, thereby efficiently applying the external force applied to the second partition to the inner container. Can contribute to the unsealing.
  • the inner container remains exposed to the discharge control chamber on substantially the entire outer surface, and the sterilization function of the inner container is not impaired.
  • the auxiliary external force imparting portion prevents the inner container from collapsing when the inner container is pulled into the second compartment due to the container shape, and properly maintains the inner container's attitude when opened. In addition, a smooth opening operation of the inner container 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 cross-sectional view taken along the line II-II in FIG. 3 is a cross-sectional view taken along the line III-III in FIG. 4 is a cross-sectional view taken along line IV-IV in FIG.
  • FIG. 5 is a view schematically showing steps (a) to (c) in the manufacturing process of the multi-chamber container of FIG.
  • FIG. 6 schematically shows this stage (d)-(f) following FIG.
  • FIG. 7 is a cross-sectional view taken along the line VII-VII in FIG.
  • FIG. 8 is a plan view of a multi-chamber container according to the second embodiment of the present invention.
  • 9 is a cross-sectional view taken along the line IX-IX in FIG.
  • FIG. 10 is a plan view of a multi-chamber container according to the third embodiment of the present invention.
  • FIG. 11 is a plan view of a multi-chamber container according to the fourth embodiment of the present invention.
  • 12 is a cross-sectional view taken along the line XII-XII in FIG.
  • FIG. 13 is a cross-sectional view taken along the line XIII-XIII in FIG.
  • FIG. 14 is a plan view of a multi-chamber container according to the fifth embodiment of the present invention.
  • FIG. 15 is a plan view of a multi-chamber container according to the sixth embodiment of the present invention.
  • 16 is a cross-sectional view taken along the line XVI-XVI in FIG.
  • FIG. 17 is a partial view in FIG. 16, but is a diagram schematically showing the positional relationship between the seal mold, the outer bag, and the inner bag when forming a strong seal as the external force applying portion.
  • FIG. 18 is a plan view of a multi-chamber container according to the seventh embodiment of the present invention.
  • FIG. 18 is a plan view of a multi-chamber container according to the seventh embodiment of the present invention.
  • FIG. 19 is a plan view of a multi-chamber container according to the eighth embodiment of the present invention.
  • 20 is a schematic side view of the inner bag manufacturing apparatus in the multi-chamber container of FIG.
  • 26 is a cross-sectional view taken along the line XXVI-XXVI in FIG. 20, where (a) shows the state before combining the seal dies, and (b) shows the state after combining.
  • 27 is a cross-sectional view taken along line XXVII-XXVII in FIG.
  • FIG. 1 10 is an outer bag (outer container of the present invention) formed by inflation or the like, and has a thickness of 200 ⁇ m.
  • a synthetic resin soft film having a multilayer structure such as a polyethylene film (the flexible film of the present invention) is used as a raw material.
  • the outer bag 10 is substantially flat and has a substantially rectangular shape.
  • the synthetic resin soft film constituting the outer bag 10 includes a pair of (upper and lower) film pieces 12 and 14.
  • the outer periphery is entirely formed in a bag shape by non-peelable welding along the opposing surface, that is, strong sealing.
  • This strong seal portion along the outer bag 10 is denoted by reference numeral 16 in FIG.
  • the sealing surface does not peel off even when the chemical solution storage portion of the outer bag 10 is pressurized from the outside.
  • the welding temperature and the welding time are set so that the above is maintained.
  • a discharge port 18 is fixed to the strong seal portion 16 at the lower portion of the outer bag 10
  • a mixed injection port 20 is fixed to the upper portion of the outer bag 10 so as to maintain a fluid-tight state.
  • the discharge port 18 and the mixed injection port 20 of the outer bag 10 are molded with a material of the same quality as a mold in order to improve the weldability with the synthetic resin soft film constituting the outer bag 10.
  • the discharge port 18 and the mixed injection port 20 are also made of polyethylene.
  • the discharge port 18 and the mixed injection port 20 are integrated with the outer bag 10 by welding to the upper and lower film pieces 12 and 14 so as not to be peeled off.
  • the film pieces 12 and 14 constituting the outer bag 10 are liquid-tight all around the discharge port 18 and the mixed injection port 20.
  • the outer bag 10 is welded (strongly sealed) so as not to be peeled so as to be connected to the strong seal portion 16 on the outer periphery of the outer bag 10 without a break.
  • the welded portions of the strong seal portion 16 with the discharge port 18 and the mixed injection port 20 are represented by 16A and 16B (FIG. 1).
  • the discharge port 18 and the mixed injection port 20 are molded products of thick synthetic resin capable of maintaining the cylindrical shape, and the structure thereof is basically the same. However, the discharge port 18 will be described. 2 includes a cylindrical main body 22, a cap 24, and a rubber plug 26.
  • the cylindrical main body 22 is integrated with the outer bag 10 at the distal end portion 22-1, by the welded portion 16A. 22 protrudes to the outside of the outer bag 10 through a tapered portion 22-2, and a cap 24 is fixed (welded) to an end portion of the cylindrical main body 22 with a rubber plug 26 interposed therebetween.
  • the rubber stopper 26 is for puncturing the needle of the infusion set.
  • the co-injection port 20 (FIG. 1) has a configuration similar to that of the discharge port 18. Although not shown, the co-injection port 20 is provided with a rubber plug similar to the rubber plug 26 of the discharge port 18, and punctures the needle for mixed injection. Can be done.
  • the strong seal portion (non-peelable weld portion) and the weak seal portion (peelable weld portion) are all formed by welding the film facing surface, but the cross-section (FIGS. 2, 3, 4 and others) 9, 12, 13, 16, and 17), the welded portions in the strong seal portion and the weak seal portion are indicated by bold lines (the strong seal is a solid line and the weak seal is a broken line). It expresses.
  • An opening 27 is formed at the upper portion of the outer peripheral strong seal portion 16 of the outer bag 10 for suspension on an infusion stand during infusion.
  • reference numeral 28 denotes a weak seal portion (first partition wall of the present invention) formed by welding the upper and lower film pieces 12 and 14 constituting the outer bag 10 so as to be peelable on the opposing surfaces (FIG. 2). And FIG. 3).
  • the weak seal portion 28 extends across the entire width of the intermediate portion in the height direction of the outer bag 10, that is, so as to be integrally connected to the strong seal portion 16 to the strong seal portion 16 on both sides of the outer bag 10. Therefore, the inner space of the outer bag 10 is separated into the upper and lower first and second compartments 29, 30. Liquid medicines are stored individually (in a separated state) in the first and second compartments 29 and 30, but liquid medicines contain amino acid-containing chemicals and glucose, respectively, for high-calorie infusions.
  • the seal surface is peeled off due to the expansion deformation of the outer bag 10 at the connection portion with the weak seal portion 28 when the chemical solution storage portions of the compartments 29 and 30 are pressurized from the outside.
  • the welding temperature and the welding time are appropriately set. Since both the strong seal portion 16 and the weak seal portion 28 are facing surfaces of the same polyethylene film, the melting point of polyethylene> the seal temperature of the strong seal portion 16> the seal temperature of the weak seal portion 28.
  • the seal temperature of the strong seal portion 16 (also a later-described strong seal portion 42) between the polyethylene films is about 150 ° C.
  • the seal temperature of the weak seal portion 28 is about 130 ° C.
  • Inner bag 32 (inner container of the present invention) is for containing supplemental drugs such as vitamins for high calorie infusion.
  • the inner bag 32 is a flat and elongated rectangle, and is accommodated between the lower compartment 30 and the discharge port 18 inside the outer bag 10.
  • the inner bag 32 is connected and fixed to the outer bag 10 by an external force applying portion (strong seal portion 42), which will be described later, and is opened in response to the fluid pressure inside the outer bag 10.
  • strong seal portion 42 an external force applying portion
  • the outer edge of the inner bag 32 that is fixed inside the strong seal portion and overlaps the strong seal portions 16 and 42 is indicated by a broken line 32 'in FIG.
  • the inner bag 32 is made of a multi-layer polyethylene film, like the outer bag 10, as in the case of the outer bag 10, but has a special surface layer that is in direct contact with chemicals for chemical resistance.
  • a trace amount or a trace amount of drug is vitamin
  • a cyclic polyolefin resin (COP) surface layer (a layer that becomes the inner surface of the inner bag 32) is formed on a base material layer made of a multilayer polyethylene film.
  • COP cyclic polyolefin resin
  • the polyethylene layer and the COP resin layer constituting the base material layer can be molded into a bag shape in a strongly integrated state under heating by inflation molding due to the strong affinity between the resins. Refer to the description of FIG. 23 regarding another embodiment shown in FIG.
  • the inner bag 32 is composed of upper and lower film pieces 34 and 36, and in this embodiment, only one liquid is accommodated for the sake of simplicity.
  • This welded portion is configured as a weak seal portion 38 (sealing portion of the present invention), and forms a drug containing chamber 39 therein, in which a trace amount drug such as vitamin is stored.
  • the weak seal portion 38 is composed of left and right side portions 38-1, 38-2 and upper and lower side portions 38-3, -4 38-4 as shown in FIG.
  • the welding temperature and welding time are set so that the value of the external force for peeling and opening the weak seal portion 38 is appropriately larger than the value of the external force for peeling and opening the weak seal portion 28 between the compartments 29 and 30. Is done.
  • the chemical solution is mixed between the compartments 29 and 30 by the opening of the weak seal portion 28 by an external force, and then a minute amount to the mixed chemical solution by the opening of the weak seal portion 38. A series of opening orders of drug introduction can be ensured.
  • the welding conditions are set separately for the same peelable seal, and the weak seal portion 28 is opened. Therefore, it is necessary to set the external force to be less than the external force for opening the weak seal portion 38.
  • the weak seal 28 that divides the compartment 29 and the bag 30 is a polyethylene film and has a temperature of about 130 ° C. as described above, while the weak seal of the inner bag 32.
  • the sealing temperature of the portion 38 is a weld between the cyclic polyolefin resin films, and the melting temperature of the material becomes high. Therefore, it is necessary to set the external force for opening the weak seal portion 28 ⁇ the external force for opening the weak seal portion 38. In addition, even a weak seal increases to about 180 ° C.
  • the discharge control chamber 40 is formed inside the outer container 10 between the lower compartment 30 and the discharge port 18 and is always open to the discharge port 18.
  • the inner bag 32 is disposed inside the discharge control chamber 40 between the second compartment 30 and the discharge port 18 in a general positional relationship with the inner bag 32.
  • the inner bag 32 is near the full width of the outer bag 10, that is, slightly on the left and right side edges of the outer bag 10.
  • the width of the inner bag 32 is somewhat narrower than the width of the outer bag 10.
  • both ends of the upper portion 38-3 of the weak seal portion 38 (sealing portion) of the inner bag 32 and both the left and right side portions 38-1, -2 is sandwiched between the film pieces 12 and 14 of which the outer edge portion constitutes the outer bag, and the strong seal portion 16 is somewhat wider at this portion to form the wider portion 16-1 (the inner bag). As long as it can hold 32, it may be the same width without being wide).
  • Both ends in the width direction of the upper portion 38-3 of the weak seal portion 38 of the inner bag 32 are integrated by being strongly sealed between the upper and lower film pieces 12 and the flange 14 in the wide portion 16-1 of the strong seal portion 16, and the lower side
  • the lower edge of the compartment 30 is partitioned, and the lower compartment 30 and the discharge control chamber 40 are separated in a liquid-tight manner. That is, the upper portion 38-3 of the weak seal portion 38 of the inner bag 32 (the weak seal portion 38 on the side close to the second compartment 30 of the inner container) and the wide portion 16-1 (inner side of the strong seal portion 16).
  • connection of the present invention in which the weak seal portion 38 on the proximity side of the container to the second compartment 30 is connected to the opposite outer peripheral side portion 16 of the outer container at both ends so as to separate the lower compartment 30 and the discharge control chamber 40 from each other.
  • the discharge control chamber 40 is always open to the discharge port 18 as described above, in this embodiment, the upper portion 38-3 of the weak seal portion 38 of the inner bag 32 is connected to the wide portion 16-1 of the strong seal 16.
  • the second partition configured by integrating the upper and lower ends of the discharge control chamber 40 is divided.
  • the discharge control chamber 40 plays a role of guiding the chemical solution in the compartments 29 and 30 together with the small amount of drug in the inner bag 32 to the discharge port 18 when the weak seal portion 38 is opened.
  • the structure of this embodiment in which the upper portion 38-3 of the weak seal portion 38 of the inner bag 32 is also used as the second partition wall serving as the lower edge of the lower compartment 30 is effective in the limited inner space of the outer bag 10.
  • the outer surface of the inner bag 32 remains open to the discharge control chamber 40 except for the welded portion (38-3, 38-1, 38-2, 44) with the strong seal (16, 42). Therefore, it is advantageous for sterilization of the inner bag 32 as described later.
  • the left and right side portions 38-1, 38-2 of the weak seal portion 38 of the inner bag 32 are also sandwiched between the film pieces 12, 14 forming the wide portion 16-1, and are strongly sealed.
  • the strong seal portion 16 wide portion 16-1 which is welded to both ends of the upper portion 38-3 of the inner bag 32 and constitutes the connecting portion of the present invention is connected to the right and left and right side portions of the inner bag 32. It is structured to be strongly welded to 38-1 and 38-2.
  • This structure holds both the left and right side portions 38-1, 38-2 of the inner bag 32 at the time of opening, thereby applying external force to the upper side portion 38-3 and the lower side portion 38-4 of the inner bag 32 in a concentrated manner. This is advantageous in that it can be opened and contribute to the smooth discharge of the chemical.
  • the inner bag 32 is in the width direction of the weak seal portion 38 along the outer periphery.
  • a strong seal portion of the upper portion 38-3 of the inner bag 32 with respect to the opposing surface of the outer bag 10 is denoted by reference numeral 42.
  • the strong seal portion 42 (external force applying portion of the present invention) is the left and right side portions of the strong seal portion 16. So as to be integrally connected to the upper side portion 38-3 of the weak seal portion 38 of the inner bag 32 (see FIGS. 2 and 3). Due to the strong seal portion 42, the inner bag 32 is fixed to the inside of the outer bag 10 on the side close to the second compartment, and the inner bag 32 is opened and opened by receiving the hydraulic pressure generated by pressurizing from the outside. Can be achieved.
  • the inner bag 32 is free from the outer bag 10 except for the point seal portion 44 described below with respect to the lower side portion 38-4 (on the side close to the discharge port 18) of the weak seal portion 38 along the outer periphery (non-side). Welding). Therefore, the non-welded portion on the outer surface of the inner bag 32 can be opened in the discharge control chamber 40.
  • the discharge control chamber 40 can be filled with a small amount of water for sterilization under wet heat in the manufacturing process of the infusion bag.
  • the inner bag 32 has an outer portion at the central portion in the width direction on the lower side portion 38-4 of the weak seal portion 38 along the outer periphery (the side of the inner bag 32 that is separated from the second compartment 30).
  • a strong seal (so-called point seal) is locally applied to the opposing surface of the bag 10, and this local strong seal portion (auxiliary external force applying portion of the present invention) is represented by 44 (see also FIG. 2).
  • the local strong seal portion 44 can contribute to the opening of the entire circumference of the inner bag 32 by external force and the maintenance of the posture at the time of opening. Since the strong seal portion 42 as the external force imparting portion of the present invention is a weld of the outer surface of the inner bag 32 to the inner surface of the outer bag 10, it is a weld between polyethylenes, and the welding temperature is about 150 ° C. as described above.
  • the inner surfaces of the inner bags 32 made of cyclic polyolefin are not welded to each other, and the strong seal portion 42 and the weak seal portion 38 (the upper portion 38-3) of the inner bag are formed. Even in the arrangement of the stacked embodiments, the weak seal portion 38 remains the weak seal portion.
  • the external force imparting portion of the present invention that transmits the external force to the outer bag 10 when the infusion bag is opened to the inner bag 32 for opening the infusion bag is constituted by a strong seal portion 42, and the strong seal portion 42 is a weak seal portion 38 of the inner bag 32.
  • the strong seal portion 42 (the welded portion between the opposing surfaces is indicated by a thick solid line) and the upper portion 38-3 of the weak seal portion 38 are substantially full width perpendicular to the paper surface. It extends to.
  • the upper and lower synthetic resin film pieces 34, 36 constituting the inner bag 32 over substantially the entire width.
  • the edge portions 34-1 and 36-1 of the upper and lower synthetic resin film pieces 12 and 14 forming the outer bag 10 are somewhat extended toward the inside of the compartment 30 along the inner surfaces thereof.
  • -1, 36-1 is strongly welded to the opposing surfaces of the upper and lower film pieces 12 and 14 constituting the outer bag 10 (the edge 34-1 of the strong seal portion 42 and the welded portion of 36-1 are 42 ')
  • the inner surfaces of the edge portions 34-1 and 36-1 of the film piece 34 and the bag 36 constituting the other inner bag 32 are separated from each other.
  • the outer bag 10 is configured as compared with the welded portion (the upper portion 38-3 of the weak seal portion 38) indicated by the thick dotted line between the inner surfaces of the film pieces 34 and the flanges 36 forming the inner bag 32.
  • the welded portion (strong seal portion 42) indicated by the thick solid line between the inner surfaces of the upper and lower film pieces 12, 14 and the outer surfaces of the film pieces 34, 36 constituting the inner bag 32 extends to the compartment (30) side. Yes.
  • the upper and lower film pieces 12 and 14 constituting the outer bag 10 are extended portions 34-1 on the side of the compartment (30) in the film pieces 34 and 36 constituting the inner bag 32 at the strong seal portion 42 (42 ′).
  • the resin layer constituting the inner surface of the inner bag 32 is a cyclic polyolefin-based resin film or the like, and the outer bag 10 and the same material (polyethylene) are formed thereon (in relation to the embodiment of FIG. 19).
  • the melting temperature of the resin (cyclic polyolefin resin, etc.) constituting the inner surface of the inner bag 32 is considerably higher than the melting temperature of the resin (polyethylene, etc.) constituting the upper layer.
  • the inner bag 32 which contains the medicine and is weakly sealed on the outer periphery (38), is accommodated inside the outer bag 10, and is clamped from the outside with a seal fitting, so that the inner surface of the outer bag 10 and the outer surface of the inner bag 32 are separated.
  • FIGS. 5 and 6 (a) to (f) illustrate an example of the manufacturing process of the infusion bag according to the first embodiment step by step, and the cylindrical synthetic resin film is wound on a roll.
  • the sheet drawn from the roll is strongly sealed and weakly sealed according to the contour shape of the infusion bag, and the outer bag material 48 becomes a strong and weak seal in the product on the cylindrical polyethylene multilayer film sheet drawn from the roll.
  • a strong seal and a weak seal are applied in advance including a part of the portion (the upper and lower opposing surfaces of the tubular sheet are welded), and then trimmed according to the contour of the outer bag 10.
  • the outer peripheral portion of the material 48 is strongly sealed in some places, and this becomes a part of the strong seal portion 16 (FIG. 1) of the product.
  • the weak seal portion 28 has already been formed.
  • the unsealed part which becomes the attachment part of the mixed injection port later is indicated by 48-1.
  • the next step (b) shows the step of inserting the manufactured inner bag 32 in advance.
  • the inner bag 32 has a weak seal portion 38 on the outer periphery, a trace amount of medicine is already stored therein, and is covered with a protective film that can be separated from the front and back surfaces.
  • the width W1 of the inner bag 32 is somewhat narrower than the width W2 of the material 48 serving as the outer bag, and the end portion 48-2 of the material 48 on the outer bag discharge port mounting side is not welded.
  • the inner bag 32 is peeled off the protective film on the front and back surfaces between the upper and lower film pieces in 48-2, it is cut individually and inserted to a predetermined position (arrow A).
  • arrow A A specific example of the inner bag manufacturing process will be described later in connection with the embodiment of FIG.
  • Step (c) shows a step of fixing (strong sealing) to the inner bag material 48 after insertion.
  • the inner side (compartment side) side portion 38-3 is strongly welded to the opposing inner surface of the outer bag material 48 to form a strong seal portion 42 (including the portion 42 'in FIGS. 2 and 3), and at the same time a strong seal portion.
  • a wide portion 16-1 where the side portions 38-1 and the collar 38-2 of the inner bag 32 are fixed is also formed.
  • the sealing mold for forming the strong seal portion (42) has a heating surface having a size corresponding to the size of the strong seal portion, but the inner and inner surfaces of the film pieces 12, 14 forming the outer bag 10.
  • the outer surfaces of the film 34 and the bag 36 constituting the bag 32 are polyethylene films, and at the temperature of about 150 ° C. as described above, the side of the compartment 30 of the inner bag 32 shown in FIGS.
  • a strong seal is formed up to the extended end portion 34-1 to the flange 36-1, and a strong seal portion 42 (also indicated by 42 ') is formed.
  • the seal mold also pressurizes the inner surfaces of the extension pieces 34-1 and 36-1 to the side of the compartment 30 in the film pieces 34 and 36 constituting the inner bag 32.
  • the sealing mold heated to about 150 ° C., the extended end portion 34-toward the compartment 30 in the film pieces 34, 36 constituting the inner bag 32. 1, 36-1 is not welded between the inner surfaces.
  • the heat of the sealing mold is also applied to the weak seal portion 38 of the inner bag 32, but the weak seal portion 38 remains weakly sealed.
  • FIGS. 7A and 7B are cross-sectional views schematically showing the formation of the strong seal portion 42 by the seal mold.
  • the mold extends to the upper die 102 and the lower die 104 (full width in the direction perpendicular to the plane of FIG. 6). ), And the outer bag material 48 and the inner bag 32 are sandwiched between the upper and lower dies 102 and 104 that are heated to a predetermined temperature of about 150 ° C., and the outer bag material 48 and the inner bag 32 face each other.
  • the surfaces are brought into close contact under heating by the upper and lower dies 102 and 104.
  • step (d) shown in FIG. 6 the end 48-4 on the discharge port side of the material 48, which is a part of the strong seal portion 16 on the outer periphery of the outer bag, is strongly sealed, and the inner bag 32 is removed on the discharge port side.
  • a point seal portion 44 (FIG. 2) that is fixed to the bag facing surface is also formed, but the portion 48-5 is left unsealed as an opening for mounting the discharge port 18.
  • the discharge port 18 is attached to the unsealed part 48-5 and strongly sealed, which has already been described with reference to FIGS.
  • the mixed injection port 20 is inserted into the remaining portion 48-1 (see also FIG. 5 (a)) and is strongly sealed in the same manner as the discharge port 18 to form strong seal portions 16A and 16B (see also FIG. 1).
  • the discharge control chamber 40 is sealed.
  • a small amount of distilled water is filled for sterilization under wet heat described later. In this state, the parts 48-6 and 48-7 of the material 48 remain unsealed.
  • each chemical solution is filled from the unsealed portions 48-6 and 48-7 of the material 48 (arrows B and C).
  • the chemical solution filling can be performed simultaneously.
  • the unsealed portions 48-6 and 48-7 are strongly sealed, and the compartments 29 and 30 filled with the respective chemical solutions are obtained.
  • F shows what was completed as an infusion bag (same as that of FIG. 1).
  • the completed infusion bag is then sterilized using a steam sterilizer.
  • the inner bag 32 of the infusion bag has side portions 38-1, 38-2 and a side portion 38-3 on the second compartment side fixed to the outer bag facing surface by strong sealing portions 16, 42, but on the outlet side
  • the side portion 38-4 is only fixed to the outer bag facing surface at the point seal portion 44, and the inner bag 32 is exposed to the discharge control chamber 40 on the entire outer surface except for the strong welding portion.
  • the outer surface of the inner bag 32 can be sterilized under wet heat. That is, the filling water to the discharge control chamber 40 in the step (e) evaporates by heating with a steam sterilizer and fills the discharge control chamber 40 as water vapor, and the outer surface of the inner bag 32 is entirely wetted with heat. It can be sterilized efficiently.
  • the infusion bag is unsealed by placing the infusion bag on a table such as a desk and pressurizing one or both of the chambers 29 and 30 with a palm from the outside.
  • a table such as a desk
  • pressurizing one or both of the chambers 29 and 30 with a palm from the outside When pressurization is performed only on the side of the compartment 29 on the side of the mixed injection port 20, the outer bag 10 is expanded at the connection portion with the weak seal 28 on the side of the compartment 29, and the space between the compartments 29 and 30 is partitioned.
  • the weak seal 28 is first opened by an external force applied to the weak seal 28.
  • both the compartments 29 and 30 are pressurized or only the compartment 30 on the outlet 18 side is pressurized, the outer bag 10 is connected to the weak seal 28 on the compartment 30 side and the weak seal.
  • connection site to 38 upper part 38-3
  • the force transmission to the connection portion of the weak seal 38 to the upper portion 38-3 is due to the synthetic resin film piece constituting the outer bag 10 being fixed to the upper portion 38-3 of the weak seal 38 by the strong seal portion 42.
  • the weak seal 28 that partitions between the compartments 29 and 30 is initially peeled, By continuing further pressurization, the weak seal 38 is peeled open.
  • the weak seal 38 is peeled and opened starting from the upper portion 38-3 which is a connection portion to the outer bag 10, but the synthetic resin film pieces 12, 14 which constitute the outer bag 10 by continuing the pressurization from the outside.
  • the part 38-4 on the discharge control chamber 40 side is also peeled open. Therefore, all of the drug solution stored in the upper compartment 29, the drug solution stored in the lower compartment 30, and the drug stored in the inner bag 32 can be guided to the discharge port 18, and the drug is infused in an unmixed state. Eliminates the fear of
  • the strong seal portion (external force applying portion of the present invention) 42 is provided along the upper portion 38-3 of the weak seal 38 (perpendicular to the plane of FIG. 2 and FIG. 3). direction).
  • Ends 34-1 and 36-1 of the upper and lower synthetic resin films 34 and 36 constituting the inner bag 32 extend toward the compartment 30, and an extended end 34-1 toward the compartment 30 side.
  • the upper and lower films 12 and 14 constituting the outer bag 10 are strongly sealed to the inner side of the bag 36-1, so that the external force due to the expansion of the upper and lower films 12 and 14 constituting the outer bag 10 when the infusion bag is opened.
  • the inner surfaces of the upper and lower films 34 and 36 constituting the inner bag 32 are welded to each other through the upper and lower film ends 34-1 and 36-1 constituting the inner bag 32 which expands following the upper and lower films 12 and 14. It is efficiently transmitted to the upper portion 38-3 of the weak seal portion 38, which is the portion, and it is possible to prompt the reliable opening of the weak seal portion 38 of the inner bag 32 using this as a base point for opening. Further, in FIG. 1, the weak seal portion 38 of the inner bag 32 is integrated with the strong seal portion 16 (wide portion 16-1 in FIG. 1) in both the left and right side portions 38-1 and 38-2.
  • the strong sealing portion 16 receives the force by which the inner bag 32 is pulled to the inner surface facing portion of the outer bag 10 when the inner bag 32 is applied to the weak sealing portion 38, the inner bag 32 is not pulled inward.
  • the upper and lower side portions 38-3 and 38-4 of the weak seal portion 38 can be reliably opened, and the infusion can be guided to the discharge port 18 without any wrinkles.
  • the inner bag 32 is strongly sealed to the outer bag facing surface by the point seal portion 44 at the side portion 38-4 on the discharge control chamber 42 side, the opening of the inner bag 32 in the full width is promoted, and the infusion is reduced. Since the inner bag 32 can be guided to the discharge port 18 and is not pulled toward the discharge port separating side at the time of opening, it can also be used to maintain the posture of the inner bag 32 appropriately.
  • a weak seal portion 60 for welding the upper and lower film pieces 34 and the flange 36 of the inner bag 32 in a peelable manner (the present invention).
  • the inner bag 32 is divided into left and right compartments 62 and 64 by the weak seal part 60, and separate auxiliary drugs can be accommodated in the respective compartments 62 and 64. it can. Therefore, the weak seal portion 60 is also opened when the weak seal portion 38 on the outer periphery of the inner bag 32 is opened by the external force applying portion (strong seal portion 42) under pressure from the outside of the chemical solution in the outer bag 10, and the compartment 62, The medicine in 64 can be discharged toward the discharge port 18.
  • FIG. 10 shows another embodiment, in which the lower end 10-1 (second compartment side) of the outer bag 10 is gradually narrowed toward the discharge port 18.
  • the inner bag 32 is located at the lower end 10-1 of the outer bag 10.
  • the inner bag 32 has a weak seal portion 38 (sealing portion of the present invention) along the outer periphery, and the weak seal portion 38 includes left and right side portions 38-1, 38-2, and upper and lower side portions 38-3, 38-4. Consists of.
  • the left right side portion 38-1 and the flange 38-2 are inclined following the shape of the lower end 10-1 flange of the outer bag 10, but are welded to the upper and lower films constituting the wide portion 16-1 in the strong seal portion 16.
  • the lower compartment 30 and the discharge control chamber 40 are isolated by the proximity side (upper side 38-3) of the weak seal portion 38 of the inner bag 32 to the compartment 30 and the portion 16-1 of the strong seal 16. It is the same that the second partition is formed. Further, the upper and lower film pieces of the outer bag 10 are strongly welded so as to overlap the upper side portion 38-3 of the weak seal portion 38 of the inner bag 32, thereby constituting a strong seal portion 42 which becomes an external force applying portion. It is the same.
  • the inside of the inner bag 32 is partitioned into upper and lower compartments 72, 74 by a weak seal portion 60 as an inner container partition.
  • FIG. 11 shows still another embodiment of the present invention.
  • both ends of the upper portion 38-3 of the weak seal portion 38 (sealing portion of the present invention) on the outer periphery are strong seals on the outer periphery of the outer bag 10. It terminates at a considerable distance from the left and right sides of the part 16. Further, the lower ends of both side portions 38-1 and the flange 38-2 of the weak seal portion 38 on the outer periphery of the inner bag 32 are also terminated from the lower side portion of the strong seal portion 16 on the outer periphery of the outer bag 10.
  • the inner bag 32 is strongly sealed to the opposing surface of the outer bag 10 along the upper portion 38-3 and both side portions 38-1, 38-1 of the weak seal portion 38, and this strong seal portion 42 is the external force applying portion of the present invention.
  • the weak seal portion 38 is peeled off by the external force applied to the outer bag 10 and the inner bag 32 is opened.
  • the strong seal portion 42 extends beyond the lower ends of the upper portion 38-3 and the side portions 38-1 and 38-2 of the weak seal portion 38 to the lower side of the strong seal portion 16 on the outer periphery of the outer bag 10.
  • the extended portion 42-1 and the flange 42-2 are provided (see also FIG. 13).
  • the extension portions 42-1, 42-2 are welded to the facing portion of the synthetic resin film constituting the outer bag.
  • the upper portion 38-3 and the both side portions 38-1 and 38-2 of the weak seal portion 38 are on the side close to the lower compartment 30 in the weak seal portion 38.
  • the extension part 42-1, 42-2 By providing the extension part 42-1, 42-2, the lower compartment 30 and the discharge control chamber 40 are separated from each other in a fluid-tight manner, that is, the extension part 42-1, 42-2 of the strong seal part 42 is the inner container.
  • the lower compartment 30 and the sealing part (38-1, 38-2 and 38-3) on the side close to the second compartment are connected to the opposite outer peripheral side part (strong seal part) 16 of the outer container at both ends.
  • the connecting portion of the present invention is configured to connect the discharge control chamber 40 while being separated.
  • the upper portion 38-3 and both side portions 38-1, 38-2 of the weak seal portion 38 and the extended portion 42-1, 42-2 of the strong seal 42 cooperate to form the second space.
  • a second partition wall of the present invention that separates the chamber 30 and the discharge control chamber 40 is configured.
  • the inner bag 32 is separated into compartments 72 and ridges 74 each containing an auxiliary drug by a weak seal portion 60 (inner container compartment portion of the present invention) extending in the lateral direction (see also FIG. 12).
  • FIG. 14 shows another embodiment, which has a lower end portion 10-1A in which the width of the outer bag 10 is narrowed. This is similar to the embodiment of FIG. 10, but the lower end portion 10-1A is shown in FIG.
  • the inner bag 32 (the outline that overlaps the strong seal portion 16 and the flange 42 is indicated by a broken line) is accommodated in this portion 10-1.
  • the inner bag 32 is provided with a sealing portion 38 (38-1, 38-2, 38-3 and 38-4) and is strong along the upper portion 38-3 adjacent to the lower compartment 30 in the sealing portion 38.
  • the structure in which the seal portion 42 is fixed to the inner surface of the inner bag 32 (which is partitioned into the upper and lower compartments 72 and 74 by the weak seal portion 60) opposite to the inner surface of the outer bag 10 is different from that in FIG. 1 and other embodiments. There is no. Further, both ends of the upper portion 38-3 and the left and right side portions 38-2 of the sealing portion 38 are sandwiched between upper and lower film pieces constituting the outer bag 10 when the strong seal portion 16 on the outer periphery of the outer bag 10 is formed. There is no difference in the structure that is attached and obtains the flow-tight structure. In this embodiment, the strong seal portion 16 maintains the same width even in the fixing portion between the right and left side portions 38-2 of the sealing portion 38.
  • the inner bag 32 is accommodated in the neck-shaped lower end 10-1A of the outer bag 10, and the inner bag 32 is reduced in size, so that dimensional accuracy is easily obtained. Further, the length of the upper and lower side portions 38-3 and 38-4 in the infusion flow direction in the sealing portion 38 is shortened, and stress at the time of opening is more concentrated, so that the inner bag 32 can be easily peeled and opened. It becomes.
  • the strong seal portion 42 overlaps (subjects) or substantially overlaps with the lower compartment 30 in the sealing portion 38 of the inner bag 32 in the proximity side, that is, the upper portion 38-3.
  • the structure is such that the strong sealing portion 42 does not cover the upper portion of the sealing portion 38 (the opposed welding portion in the strong sealing portion 42 is substantially only on the compartment 30 side).
  • FIG. 5 is basically the same as FIG. 1, and the inner bag 32 is the outer bag. 10 is extended to the strong seal portion 16 on the outer periphery, and a fluid tight structure between the lower compartment 30 and the discharge chamber 40 is obtained. Unlike FIG.
  • the strong seal portion 16 does not include the wide portion 16-1, and both ends of the inner bag 32 are sandwiched and sealed between the upper films constituting the strong seal portion 16.
  • the sealing portion (weak seal portion) 38 includes left and right side portions 38-1, 38-2, and upper and lower upper and lower side portions 38-3, 38-4.
  • the inner bag 32 is divided into left and right compartments 62 and 64 by the longitudinal weak seal portion 60.
  • the strong seal portion 42 as the external force imparting portion fixes the inner surface of the outer bag 10 to the opposing outer surface of the inner bag 32, but the strong seal portion 42 is closer to the compartment 30 than the sealing portion 38-3. The arrangement is such that both are hardly or not worn. That is, as shown in FIG.
  • the strong welding between the upper and lower films 12 and 14 constituting the outer bag 10 and the upper and lower synthetic resin film pieces 34 and 36 constituting the inner bag 32 is substantially the end edge portion 34-1, It is done only in 36-1.
  • the synthetic resin film pieces 12 and ridges 14 constituting the outer bag 10 are not welded to the synthetic resin film pieces 34 and ridges 36 constituting the inner bag 32 in the sealing portion 38-3.
  • FIG. 17 is a cross-sectional view schematically showing the formation of the strong seal portion 42 by the seal mold in this embodiment according to FIG. 7 (b).
  • the bag 30 and the inner bag 32 are sandwiched, and the film bag 34 and the bag 36 constituting the inner bag 32 are extended from the sealing portion 38-3 to the second compartment 32 with the outer bag 10 interposed therebetween. Pressurization of 34-1, 36-1 is performed.
  • the upper and lower dies 102 and 104 do not press the opposing surfaces of the outer bag 10 and the inner bag 32 on the sealing portion 38-3 side from the extended end portion 34-1 and the flange 36-1.
  • the extended end portions 34-1 and 36-1 are welded to the opposing surfaces of the upper and lower film pieces 12 and 14 constituting the outer bag 10 so as not to substantially cover the sealing portion 38-3 (extended).
  • the opposed inner surfaces of the protruding end portions 34-1 and 36-1 are not welded by the high melting temperature layers), and a strong seal portion 42 is formed as an external force applying portion (FIG. 16).
  • the external force due to the expansion between the film pieces 12 and the ridges 14 constituting the outer bag 10 at the time of opening is applied to the opening portion 38-3 via the edge portions 34-1 and 36-1 on the compartment side. Since it can transmit efficiently, reliable opening is realizable. Then, in comparison with the welded structure in which the strong seal portion 42 as the external force applying portion is overlapped with the opening portion 38-3, in the case of the structure in which the strong seal portion 42 is overlapped with the opening portion 38-3, FIG.
  • the welded portion overlaps four places at the top and bottom, and the container tends to be hard at this portion, but in this embodiment, the strong seal portion 42 (thick solid line) and the unsealed portion 38-3 (thick broken line) ) Can be prevented from becoming too hard because the container does not overlap or substantially does not overlap.
  • FIG. 18 is a modified embodiment of the embodiment of FIG. 8, and the sealing portion (weak seal portion) 38 of the inner bag 32 includes left and right side portions 38-1, 38-2, and upper and lower side portions 38-3, 38-. With four. However, the inner bag 32 is downsized and the left and right widths are narrower, and the upper and lower side portions 38-3 and 38-4 do not reach the strong seal portions 16 on the left and right sides.
  • the strong seal portion 42 as an external force imparting portion strongly seals the inner surface of the outer bag 10 to the outer surface of the inner bag 32 at the upper portion 38-3 of the sealing portion 38.
  • portions 42A and ridges 42B beyond the upper portion 38-3 of the seal portion 38 extend to the strong seal portions 16 on the left and right sides of the outer bag 10 and are integrally connected thereto.
  • the upper portion 38-3 of the sealing portion 38 of the inner bag 32 is in the strong seal portions 42 on both sides thereof. This is performed by extending to the strong seal portion 16 through the portions 42A and 42B where the upper and lower film pieces of the outer bag 10 are welded, and being integrally connected thereto.
  • the portions 42A and ridges 42B may be configured as weak seals that weld the opposing inner surfaces of the outer bag 10 in a peelable manner.
  • the strong seal portion 42 as the external force imparting portion is configured to cover the upper portion 38-3 of the sealing portion 38 of the inner bag 32 in accordance with FIGS. 3 and 7, and the flow between the compartment 30 and the discharge control chamber 40. A tightly separated state can be ensured. That is, when the strong seal portion 42 has a structure that does not overlap the upper portion 38-3 of the sealing portion 38 of the inner bag 32 as shown in FIG. 16, the upper portion 38-3 of the sealing portion 38 of the inner bag 32 Liquid leakage occurs at the connection portions of the strong seal portion 42 with the portions 42A and 42B, and the function as the second partition wall of the present invention is lost. Therefore, in order to ensure the function, the seal portions 42 and 38-3 It is necessary to overlap.
  • FIG. 19 shows the multi-chamber container of the eighth embodiment, which is similar to the embodiment of FIG. 14, but the shape of the lower part of the chemical solution bag is somewhat different, and the inner bag is in the outer bag 10.
  • the strong welded portion 16-1 of the outer bag 10 fixes 32. That is, the strong welded portion 16-1 has a narrow tip 16-1A extending from the strong seal portion 16 on the outer periphery of the outer bag 10 toward the inner bag 32 to the upper corner (side of the compartment 30) of the inner bag 32.
  • the strong welded portion 16-1 has a narrow tip 16-1A extending from the strong seal portion 16 on the outer periphery of the outer bag 10 toward the inner bag 32 to the upper corner (side of the compartment 30) of the inner bag 32.
  • the inner bag 32 is basically free from the outer bag 10 on the discharge port 18 side from the tip end portion 16-1A, but the inner bag 32 is disposed at both ends of the lower side portion 38-4, that is, is discharged. It is fixed to the outer bag 10 by point seal portions 44-1, 44-2 so as to sandwich the outlet 18. That is, the upper and lower film surfaces of the outer bag 10 are strongly welded to the lower side portion 38-4 of the weak seal portion 38 of the inner bag 32 at the local site indicated by 44-1 and 44-2.
  • the inner bag 14 and the inner bag 32 have a rectangular shape elongated in the width direction of the outer bag 10, and the inside thereof is partitioned into upper and lower compartments 72, 74 by a weak seal portion 60 as an inner container partitioning portion.
  • a weak seal portion 60 as an inner container partitioning portion.
  • FIGS. 20 and 21 the tubular sheet material 80 constituting the inner bag 32 is wound around a roll R formed by inflation or the like. It has been.
  • Figure 22 is a cross-sectional shape of the film F which constitutes the sheet material 80 is shown schematically, cyclic polyolefin on one surface of the polyethylene substrate layer F 1 made of multilayer polyethylene film (the inner surface and comprising a layer of inner bag 32) A resin (COP) layer F 2 is formed, and a protective film F 3 made of polyamide resin (nylon) is detachably attached to the other surface (the layer that becomes the outer surface of the inner bag 32). As shown in FIG.
  • driving units 82-1 and 82-2 for pulling out the sheet-like material 80 from the roll R are installed on the downstream side.
  • the driving units 82-1 and 82-2 are provided with appropriate driving devices, and are configured to be able to control the intended pulling movement of the sheet-like material 80 from the roll R.
  • the polyamide resin layer F 3 does not have enough affinity for the base material layer F 1 to be integrated, inflation is performed while maintaining mutual adhesion (can be peeled off).
  • the polyamide resin layer F 3 (protective film) is maintained in an adhesive state in the inner bag chain forming step described below for the tubular sheet-shaped material 80.
  • the protective film F 3 is not particularly limited as long as it has a low affinity with the polyethylene base layer, and polypropylene, ethylene vinyl alcohol copolymer, and the like can also be used.
  • FIG. 23 schematically shows a cross-sectional shape of the sheet-like material 80 immediately after being pulled out from the roll R.
  • the sheet-like material 80 has a flat bag shape with both ends closed.
  • 22 is a cyclic polyolefin resin (COP) layer F 2 .
  • a center seal device (mold) 86-1 and 86-2 are arranged between the guide rollers 84 and 85, and the sheet is temporarily stopped at the position of the molds 86-1 and 86-2.
  • the inner surfaces the cyclic polyolefin resin (COP) layer F 2
  • the seal molds 86-1 and 86-2 are moved by the length of the heating surface when the seal molds 86-1 and 86-2 are opened, and the sealing process is repeated by combining the seal molds 86-1 and 86-2.
  • the weak seal portion (center seal) 80A is formed over the entire length along the center line of the sheet-like material 78, and becomes the weak seal portion 60 of the pouch 38 in FIG.
  • Weak seal temperature of the cyclic polyolefin resin (COP) layer F 2 together to form a center seal 80A is already as 180 ° C. of about description in connection with the embodiment of FIG.
  • a cutter 88 is disposed downstream of the guide roller 84-2, and both end edges in the width direction of the sheet-like material 80 are cut by the cutter 88, and the sheet-like material 80 has openings 80B on both sides thereof as shown in FIG. -1, 80B-2 is formed.
  • the injection main body 90-1 and 90-2 are arranged on the center seal 80A inside the sheet-like material 80 through the openings 80B-1 and 80B-2 of the sheet-like material 80 from both sides.
  • the insertion position is along the line (see also FIG. 26 (a)).
  • the liquid injection nozzles 92-1 and 92-2 are fitted and fixed to the liquid injection main bodies 90-1 and 90-2 having a cylindrical shape so as to extend over the entire length along the center line.
  • the upper ends of the liquid injection nozzles 92-1 and 92-2 are connected to the liquid medicine supply pipes 93-1 and 93-2 (FIG. 21), and the medicine supply pipes 93-1 and 93-2 are opened in the sheet-like material 80.
  • the parts 80B-1 and 80B-2 extend outside and are connected to respective drug supply sources (tank, pump, etc.) not shown.
  • Side seal molds 94-1 and 94-2 are disposed so as to sandwich the liquid injection main body 90-1 and the first 90-2 through the sheet material 80. As shown in FIG. 26 (a), the seal mold 94-1, 94-2 has a concave surface 94- shaped to substantially follow the upper and lower halves of the injection main body 90-1, 90-2 in the cross section.
  • the concave surfaces 94-1A and 94-1B; 94-2A and 94-1B extend from the upper end surface to the lower end surface of the mold 94-1 and 94-1 as shown in FIG.
  • the flat surfaces 94-1C and 94-2C seal both sides of the sheet material 80.
  • the seal die for cross 95-1 and 95- are positioned below the side seal dies 94-1 and 94-2 (positions where the length of one drug sealing portion is separated). 2 is placed.
  • FIG. 26 (a) shows the open position of the seal molds 94-1, 94-2
  • FIG. 26 (b) shows that the seal molds 94-1, 94-2 are combined from the position of FIG. 26 (a).
  • the seal position is shown.
  • the flat surfaces 94-1C and 94-2C are combined (left and right in FIG. 20) with the sheet material 80 interposed therebetween, whereby the side seals 80C-1 and 80C-2 (weakness of the inner bag 32 in FIG. 19) are combined.
  • the upper and lower side portions 38-3 and 38-4 of the seal portion 38 are formed, and the seal molds 95-1 and 95-2 are combined (left and right in FIG. 20) to cross the sheet-like material 80.
  • a seal 80D (becomes left and right side portions 38-1, 38-2 in the weak seal portion 38 of the inner bag 32 in FIG. 10) is formed. Also, the concave surfaces 94-1A, 94-1B; 94-2A, 94-1B of the molds 94-1 and 94-2 substantially follow the upper and lower halves of the outer diameters of the liquid injection bodies 90-1 and 90-2. Because of its shape, the sheet material 80 is sandwiched between the concave surfaces 94-1A, 94-1B; 94-2A, 94-1B and the outer diameter surfaces of the liquid injection main bodies 90-1, 90-2.
  • the sheet-like material 80 has a concave surface 94-1A, 94-1B; 94-2A, 94-1B as shown in FIG.
  • Cavities 80E-1 and 80E-2 having a length corresponding to the length of the sealing molds 94-1 and 94-2 are formed in accordance with the curved shape.
  • the hollow portions 80E-1 and 80E-2 serve as upper and lower compartments 72 and 74 in the weak seal portion 38 of the inner bag 32 shown in FIG.
  • the seal molds 95-1 and 95-2 are combined to form a cross seal 80D.
  • the sealing molds 94-1, 94-2 and 95-1, 95-2 are divided into left and right as shown in FIG.
  • the cross seal 80D is connected to the hollow portions 80E-1 and 80E-2 newly defined by the combination of the seal dies 95-1 and 95-2 this time.
  • the bottoms of the hollow portions 80E-1 and 80E-2 defined by the combination of -1 and 95-2 are closed.
  • the connected cavities 80E-1 and 80E-2 are still open on the top side, and the lower ends 92-1A and 92-2A of the injection nozzle 92-1 and 92-2 are cavities whose upper ends are still open.
  • Portions 80E-1 and 80E-2 are opened (FIG. 21). Then, the medicines 96-1, 96-2 are fed from the respective medicine supply sources (pumps, etc.) into the hollow portions 80E-1, 80E-2 whose upper ends are still open. A predetermined amount is injected from 92-1A and 92-2A.
  • the sealing molds 94-1, 94-2 and 95-1, 95-2 are combined again to form a cross seal 80D by combining the sealing dies 95-1 and 95-2. Seal 80D closes the top of the cavity 80E-1 and 80E-2 defined by the combination of the previous sealing mold 95-1 and 95-2 after the injection of the drug 96-1 and 96-2 has been completed.
  • a new side seal 80C-1, 80C is formed by combining the sealing molds 94-1 and 94-2. -2 are formed, and new hollow portions 80E-1 and 80E-2 are formed which are open at the top, and thereafter, by repeating the same operation, each of them becomes the inner bag 32 of the multi-chamber container of FIG.
  • the chain M (hereinafter referred to as the inner bag chain) of the drug filling portion is configured.
  • the inner bag chain M is transferred to the multi-chamber container manufacturing facility in which the protective film F 3 is adhered to the front and back surfaces and the steps of FIGS. 5 and 6 are performed in this state.
  • the protective film F 3 can be secured foreign matter adhesion prevention and sterility of the inner bag chain body M in the transfer process moderate.
  • the multi-chamber container manufacturing process of FIG. 5 is performed, the protective film F 3 in the inner bag chain M is peeled, and then the cross seal 80D is cut in the middle so that the inner bag 32 is completely separated.
  • the step of inserting the inner bag 32 can be performed as described in 5 (b).
  • edge welded portion 44 ... point seal portion (auxiliary external force applying portion of the present invention) 80 ... Sheet-like material 80A ... Center seal 80B-1, 80B-2... Opening 80C -1, 80C-2 ... Side seal 80D ... Cross seal 80E-1, 80E-2 ... Cavity 82-1, 82-2 ... Drive unit 86-1, 86-2 ... Center sealing mold 88 ... Cutter 90-1, 90-2 ... Injection body 92-1, 92-2 ... Injection nozzle 93-1, 93-2 ... Drug injection tube 94-1, 94-2 ... Seal mold for side 95-1, 95-2 ... Cross seal mold

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Package Specialized In Special Use (AREA)
  • Packages (AREA)

Abstract

La présente invention concerne un contenant multi-compartiment destiné à des transfusions et autres et conçu pour pouvoir : garantir l'ordre d'ouverture du contenant multi-compartiment, cet ordre d'ouverture étant l'ouverture initiale d'une section à joint faible entre les compartiments divisés, suivie par l'ouverture d'une section à joint faible d'un petit contenant ; et éviter de façon fiable une erreur d'opération, à savoir une transfusion en n'utilisant que certains des médicaments. Le contenant multi-compartiment comprend une poche extérieure (10) et une poche intérieure (32). La poche extérieure (10) comprend, en tant que section (28) à joint faible, une première paroi de séparation. L'intérieur de la poche extérieure est divisé par la section (28) à joint faible en compartiments séparés (29, 30) qui reçoivent chacun un médicament liquide. La poche intérieure (32) a son périmètre extérieur scellé par une section à joint faible (38) et y loge un médicament. Tout ou partie de la section (38) à joint faible sert également de seconde paroi de séparation, afin de séparer un compartiment (30) divisé côté inférieur d'une chambre (40) de commande d'évacuation. La pression externe qui ouvre la section (38) à joint faible de la poche intérieure (32) est réglée supérieure à la pression externe qui ouvre la section (28) à joint faible qui sépare les compartiments divisés (29, 30). La section (28) à joint faible est ouverte en premier, puis le joint de la poche intérieure (32) est ouvert en conséquence de la pression externe appliquée sur le médicament liquide logé dans la poche extérieure (10).
PCT/JP2013/085066 2012-12-28 2013-12-27 Contenant multi-compartiment WO2014104281A1 (fr)

Priority Applications (2)

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CN201380063856.7A CN104837465B (zh) 2012-12-28 2013-12-27 多室容器
KR1020157019002A KR101817492B1 (ko) 2012-12-28 2013-12-27 복실 용기

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JP2012287303 2012-12-28
JP2012-287303 2012-12-28
PCT/JP2013/067891 WO2014103411A1 (fr) 2012-12-28 2013-06-28 Récipient multi-chambres
JPPCT/JP2013/067891 2013-06-28

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WO2014104281A1 true WO2014104281A1 (fr) 2014-07-03

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PCT/JP2013/085066 WO2014104281A1 (fr) 2012-12-28 2013-12-27 Contenant multi-compartiment

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JP2016120040A (ja) * 2014-12-25 2016-07-07 エイワイファーマ株式会社 輸液容器及びその製造方法
JP2018533457A (ja) * 2015-11-13 2018-11-15 重慶莱美薬業股▲ふん▼有限公司Ｃｈｏｎｇｑｉｎｇ Ｌｕｍｍｙ Ｐｈａｒｍａｃｅｕｔｉｃａｌ Ｃｏ．，Ｌｔｄ． 単針薬物ミキサー、ハードデュアルインターフェースおよび輸液ソフトバック
JP2018535071A (ja) * 2015-11-13 2018-11-29 重慶莱美薬業股▲ふん▼有限公司Ｃｈｏｎｇｑｉｎｇ Ｌｕｍｍｙ Ｐｈａｒｍａｃｅｕｔｉｃａｌ Ｃｏ．，Ｌｔｄ． 薬物ミキサー、ハードデュアルインターフェースおよび輸液ソフトバック
US20230270102A1 (en) * 2020-07-21 2023-08-31 W.L. Gore & Associates, Inc. Bag for easy drainage and manipulation

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CN108024301B (zh) * 2016-11-04 2022-07-26 夏普株式会社 基站、用户设备及其执行的方法
KR101964384B1 (ko) * 2017-08-25 2019-04-01 씨제이헬스케어 주식회사 의료용 수액백
CN107583084B (zh) * 2017-11-02 2023-04-25 山东新华医疗器械股份有限公司 灭菌器密封结构
JP7365256B2 (ja) * 2020-02-07 2023-10-19 エイワイファーマ株式会社 複室容器
CN118061597B (zh) * 2024-04-25 2024-06-21 湖南大道新材料有限公司 化妆品干湿分离包装袋及其生产设备

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Publication number Priority date Publication date Assignee Title
JP2016120040A (ja) * 2014-12-25 2016-07-07 エイワイファーマ株式会社 輸液容器及びその製造方法
JP2018533457A (ja) * 2015-11-13 2018-11-15 重慶莱美薬業股▲ふん▼有限公司Ｃｈｏｎｇｑｉｎｇ Ｌｕｍｍｙ Ｐｈａｒｍａｃｅｕｔｉｃａｌ Ｃｏ．，Ｌｔｄ． 単針薬物ミキサー、ハードデュアルインターフェースおよび輸液ソフトバック
JP2018535071A (ja) * 2015-11-13 2018-11-29 重慶莱美薬業股▲ふん▼有限公司Ｃｈｏｎｇｑｉｎｇ Ｌｕｍｍｙ Ｐｈａｒｍａｃｅｕｔｉｃａｌ Ｃｏ．，Ｌｔｄ． 薬物ミキサー、ハードデュアルインターフェースおよび輸液ソフトバック
US20230270102A1 (en) * 2020-07-21 2023-08-31 W.L. Gore & Associates, Inc. Bag for easy drainage and manipulation

Also Published As

Publication number Publication date
CN104837465A (zh) 2015-08-12
KR20150099563A (ko) 2015-08-31
CN104837465B (zh) 2018-03-27
KR101817492B1 (ko) 2018-01-11
WO2014103411A1 (fr) 2014-07-03

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