WO2007055355A1 - Multichamber container - Google Patents

Multichamber container Download PDF

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Publication number
WO2007055355A1
WO2007055355A1 PCT/JP2006/322564 JP2006322564W WO2007055355A1 WO 2007055355 A1 WO2007055355 A1 WO 2007055355A1 JP 2006322564 W JP2006322564 W JP 2006322564W WO 2007055355 A1 WO2007055355 A1 WO 2007055355A1
Authority
WO
WIPO (PCT)
Prior art keywords
bag
storage bag
medicine storage
medicine
opening
Prior art date
Application number
PCT/JP2006/322564
Other languages
French (fr)
Japanese (ja)
Inventor
Shoji Igota
Kaoru Shimizu
Original Assignee
Ajinomoto Co., Inc.
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 Ajinomoto Co., Inc. filed Critical Ajinomoto Co., Inc.
Priority to JP2007544218A priority Critical patent/JP4962733B2/en
Publication of WO2007055355A1 publication Critical patent/WO2007055355A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093Containers having several compartments for products to be mixed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2024Separating means having peelable seals

Definitions

  • the internal cavity is separated by the weak seal portion, thereby forming a plurality of compartments for individually storing and storing the drug, and opening the weak seal portion during use.
  • the present invention relates to a multi-chamber container that is mixed and discharged.
  • multi-liquid mixing type multi-chamber containers for infusion and dialysis.
  • a multi-chamber container the internal cavity of a medicine bag made of a soft film is separated into a plurality of compartments each containing a different chemical solution by a weak seal.
  • the outer periphery of the medicine storage bag is provided with a chemical liquid discharge port as a rigid plastic molded product capable of maintaining its shape, the chemical liquid discharge port is formed in a cylindrical shape, and the internal cavity is at one end on one side. Force opening to the chamber The other end has a rubber stopper.
  • the weak seal part Prior to administration of the drug solution to the patient, the weak seal part is opened by applying external force to the drug storage bag, and the internal cavity of the drug storage bag becomes a single chamber.
  • the puncture needle can be used to puncture a rubber stopper, allowing the drug solution to be administered from the drug storage bag. Therefore, in this type of multi-chamber container, it is essential to open the weak seal part by mixing the two liquids prior to the administration of the chemical liquid. On the other hand, it is necessary to discharge the chemical liquid without opening the weak seal part.
  • the rubber stopper was punctured at the outlet, there was a possibility of an erroneous operation in which only the drug solution in the compartment on the drug solution outlet side was administered.
  • a second weak seal portion is provided immediately before the chemical solution discharge port.
  • the second weak seal part is placed next to the first weak seal part. It has been proposed to open the doors in order so that discharge is performed after mixing of the chemicals (see Patent Document 1).
  • Patent Document 1 Japanese Patent Laid-Open No. 9 327498
  • a second weak seal portion is provided immediately before the chemical solution outlet, and these weak seal portions are sequentially opened.
  • the strength of trying to prevent the administration of unmixed chemicals is provided with two weak seals, which complicates the manufacturing process and makes it very difficult to accurately manufacture multiple weak seals with different strengths. This is a difficult task, increases costs, and forces the user to perform two-stage pressurization work, which is always good for workability.
  • the first weak seal part ⁇ the second weak seal part may not always be opened, but the second weak seal part on the chemical solution outlet side is not necessarily opened. If the part is opened first, there is a possibility of shifting to the administration work as it is, and in this case, only one solution is administered without mixing.
  • the present invention has been made in view of the above-mentioned problems. Administration is performed in an unopened state, and a novel structure of a multi-chamber container is provided. The purpose is to more surely eliminate the possibility of erroneous operation in which administration is performed in an unmixed state despite good side workability.
  • the mixed drug-sealed bag-like material includes a drug storage bag formed of a flexible film, a discharge port for discharging the drug, and an internal cavity of the drug storage bag.
  • a weak seal portion that separates into a plurality of compartments for storing the medicines, is opened by a pressing force applied to the medicine storage bag from the outside, and mixes the medicines stored in the respective compartments. It is equipped with.
  • the sealing bag which is formed of a flexible film that is more fragile than the flexible film that constitutes the medicine storage bag and is located inside the medicine storage bag, is provided in the space between the medicine storage bag and the inner space of the medicine storage bag.
  • the outlet is surrounded and disposed so as to close the open end to the chamber, and the inner surface of the medicine storage bag is welded and joined to the opposite outer surface of the sealing bag at a small area to form an opening portion, and the pressing at the time of opening is performed.
  • the sealing bag is broken at the opening, the discharge port is opened in the internal cavity of the drug storage bag, and the mixed drug is discharged from the discharge port.
  • the discharge port is normally closed by a sealing bag inside the medicine storage bag, and the sealing bag is firmly welded and joined to the opposite surface of the medicine storage bag at the opening portion as a small area portion. . Therefore, by appropriately selecting the material and thickness of the synthetic resin film constituting the sealing bag, the size of the opening portion, the shape of the opening portion, etc., the internal fluid pressure during the mixing operation can reliably destroy only the sealing bag. Thus, the mixed drug can be discharged from the discharge port.
  • the separation seal (weak seal) that should be mixed with the two liquids and the opening part that prevents the administration of the mixed drug to be opened by a separate mechanism can achieve reliable “step-by-step” communication. It is.
  • FIG. 1 is a plan view of the multi-chamber container of the present invention (a view taken in the direction of arrow I in FIG. 2).
  • FIG. 2 is a cross-sectional view of the multi-chamber container of the present invention, and is a view taken along the line II-II in FIG.
  • FIG. 3 is a partial view of the vicinity of the discharge port in FIG. 2 and schematically shows the state when the multi-chamber container of the present invention is opened.
  • FIG. 4 is a schematic view showing an example of a point seal method in a series of steps.
  • FIG. 5 is a schematic view showing another example of the point sealing method in FIG. 4 in a series of steps.
  • FIG. 6 shows a discharge port with an internal bag mounted with a point seal support plate.
  • FIG. 7 is a perspective view schematically showing a state in which the point seal support plate is attached to the discharge port in FIG.
  • FIG. 8 shows the vicinity of the discharge port of the multi-chamber container in another embodiment in which the opposing surfaces of the drug storage bag 10 and the inner bag 13 are connected by a substantially full-width heat seal portion in addition to the point seal.
  • the multi-chamber container is a flat medicine storage bag (external bag) 10 for storing medicine, a discharge port 12 fixed to the outer periphery of the medicine storage bag 10, and a medicine.
  • a force is also configured with a small-capacity sealing bag (inner bag) 13 that seals the outlet 12 in the normal state against the inner cavity of the storage bag 10.
  • the drug storage bag 10 is made of a soft film (a flexible material of the present invention) having a multilayer structure such as a polypropylene film or a polyethylene film having a thickness of 200 microns.
  • This medicine storage bag 10 can be a bag made of tube-like inflation film or a container made of blow-molded bag, in addition to the above-described bag-making from a film.
  • a suspension hole 16 is formed in the strong seal portion 14, and the medicine storage bag 10 is suspended and held by the suspension hole 16 on an infusion stand or the like to perform infusion or dialysis.
  • the weak seal portion 18 is formed by pressurizing the front and back surfaces of the synthetic resin film section forming the drug storage bag 10 at a low temperature (110 ° C. in the case of polypropylene) slightly higher than its softening temperature.
  • the strong seal portion 14 remains as it is by pressurizing the drug solution in the drug storage bag 10 from the outside in the compartments 20 and 22 while the respective drug solutions are stored in the first compartment 20 and the second compartment 22.
  • the weak seal portion 18 can be broken and opened by fluid pressure (pressure of the chemical solution during pressurization) to mix the first chemical solution and the second chemical solution.
  • the discharge port 12 is made of a synthetic resin having a thickness and rigidity capable of maintaining its form (the same plastic material as the drug storage bag 10 is used to obtain adhesion to the drug storage bag 10). (Preferred).
  • the discharge port 12 is formed in a cylindrical shape having openings at both ends, the middle forming a tapered portion 12-1, and the upper end having a flange portion 12-2 (FIG. 1).
  • the cap 12-3 is abutted and welded to the flange 12-2, and the rubber inner lid 12-4 (the plug of the present invention) is attached to the bottom opening of the cap 12-3.
  • the inner lid 12-4 is punctured by the puncture needle of the infusion set, and the inner cavity of the medicine storage bag 10 is communicated with the infusion tube to perform infusion.
  • the synthetic resin film that forms the front and back surfaces of the medicine storage bag 10 is moved up and down the cylindrical portion of the discharge port 12 through the synthetic resin film that forms the front and back surfaces of the sealing bag 13. Heating and adhering while sandwiching, the medicine storage bag 10 is sealed with respect to the discharge port 12.
  • the small-capacity sealing bag 13 is provided inside the medicine storage bag 10 and is provided to seal the discharge port 12 in a normal state.
  • the sealing bag 13 is similar to the drug storage bag 10 in that the upper and lower synthetic resin film sections, such as polypropylene film and polyethylene film, are heated at the outer peripheral portion 13A (the welding temperature of the strong seal portion 14 of the drug storage bag 10). It is formed by welding at the same temperature), but as described later, it is sealed so that it can be ruptured at the point seal part by opening the medicine storage bag 10 by the fluid pressure when opening the weak seal 18.
  • the synthetic resin film constituting the stopper bag 13 is considered to be weaker than the synthetic resin film constituting the drug storage bag 10 in terms of strength.
  • the inner and outer bags are made of the same synthetic resin material.
  • the thickness can be made appropriately thinner than that of the synthetic resin film constituting the medicine storage bag 10.
  • the required strength difference between the inner and outer bags can be reduced by making the polymerization degree of the synthetic resin constituting the drug storage bag 10 smaller than the polymerization degree of the synthetic resin constituting the sealing bag 13 or by using a copolymer.
  • the sealing bag 13 is sterilized under the heat and humidity in the sealing bag 13 by assembling a microscopic hole through which a liquid having a flow rate very slow compared to the drip rate can pass (aseptic sterilization). ) It is advantageous for operation.
  • the sealing bag 13 has a width that is somewhat larger than the outer diameter of the discharge port 12 and extends toward the internal cavity of the drug storage bag 10 when the drug storage bag 10 is not opened.
  • the sealing bag 13 is attached to the discharge port 12 together with the medicine storage bag 10 as described later. That is, the strong seal portion 14 on the outer periphery of the medicine storage bag 10 is welded to the outer periphery of the discharge port 12 in the portion 14-1, and the outer peripheral portion 13-1 of the sealing bag 13 is also overlapped and welded at the time of this welding. (See Figure 2).
  • the sealing bag 13 is normally closed with respect to the internal cavity (compartment 22) of the medicine storage bag 10, that is, when the weak seal portion 18 is not opened, the medicine in the medicine storage bag 10 is closed. Is blocked from going to the outlet 12.
  • the outer surface of the sealing bag 13 is welded (point-sealed) to the opposing inner surface (upper and lower inner surfaces) of the medicine storage bag 10 with a small area portion 30.
  • This small area portion 30 where the outer surface of the sealing bag 13 is welded to the opposite inner surface of the drug storage bag 10 has a rectangular shape with a sharp corner as shown by the hatched area in FIG.
  • the temperature is as high as the welding temperature of the strong seal portion 14 on the outer periphery of the drug storage bag 10.
  • the medicine storage bag 10 When the weak seal portion 18 is opened, the medicine storage bag 10 is expanded, and the sealing bag 13 whose outer surface is welded to the opposite inner surface of the medicine storage bag 10 with a small area portion 30 receives a tensile force in the vertical direction and is small. Since the welding of the area portion 30 is strong, a tearing force is generated in the sealing bag 13, and the synthetic resin film constituting the sealing bag 13 is stronger than the synthetic resin film constituting the drug storage bag 10. There is also the effect of stress concentration caused by the weak and sharp shape of the small area part 30. As the drug storage bag 10 is expanded, the sealing bag 13 is strongly bowed at the point seal part 30 as shown in Fig. 3.
  • the sealing bag 13 is It is ruptured at the into-seal portion 30 and the discharge port 12 is opened, so that the chemical solution can be discharged. That is, in order to open the medicine storage bag 10, the medicine storage bag 10 is placed flat on a desk or the like as shown in FIG. 2, and the medicine storage bag 10 is pressurized with a palm from the top as shown by an arrow b ( As shown in FIG. 3, it is preferable to pressurize the medicine storage bag 10 on the compartment 20 side, but the compartment 22 side may be pressurized or both sides may be pressurized. By pressurizing the medicine storage bag 10, a hydraulic pressure is applied to the weak seal portion 18, and the weak seal portion 18 is instantaneously broken and opened by a predetermined pressure.
  • the internal pressure of the medicine storage bag 10 is increased by pressurization, and this increased pressure is released at once by opening and closing the weak seal portion 18, so that a shocking flow of the chemical solution flows into the medicine storage bag 10. Induced.
  • FIG. 3 the flow of the shocking chemical liquid induced in the medicine storage bag 10 is schematically shown by an arrow F.
  • the rapid flow F of the chemical solution induced in the medicine storage bag 10 when the weak seal portion 18 is opened causes the medicine storage bag 10 to be greatly expanded as shown in FIG. Therefore, a large tearing force is generated in the small-capacity sealing bag 13 firmly welded to the opposite surface of the medicine storage bag 10 at the small area portion 30, and the synthetic resin film constituting the sealing bag 13.
  • the point seal portion of the sealing bag 30 is torn while it is welded to the medicine storage bag 10 as shown by 13 '.
  • an opening 40 is formed in the sealing bag 13, and the medicine opens as indicated by an arrow.
  • the rubber plug 12-3 is punctured with a puncture needle of an infusion set (not shown) to discharge the mixed drug solution. It becomes possible.
  • the opening of the isolation seal (weak seal 18) to be mixed with the two liquids and the opening of the opening (point seal 30) for preventing the administration of the mixed drug are said to be “stepwise”. ⁇ Because of the opening structure, it is possible to achieve reliable communication during opening work.
  • the acute rectangular shape of the small area portion 30 can contribute to causing the sealing bag 13 to burst more reliably due to the stress concentration effect. Then, by optimally setting the composition and thickness of the synthetic resin film constituting the sealing bag 13, the medicine to the outlet 12 when the medicine storage bag is not opened (when the weak seal 18 is closed) is used. Inflow prevention (maintaining the closed state of the outlet / outlet 12 by the sealing bag 13), while the drug storage bag is opened (when the weak seal 18 is opened) It can be discharged Can be done.
  • the upper and lower synthetic resin films forming the medicine storage bag 10 are arranged on the outer periphery as shown in (a).
  • the strong seal portion 14 is not welded at the portion 14A, and an opening is exhibited at the unwelded portion.
  • the sealing bag 13 is already stored in the medicine storage bag 10, and the outer peripheral portion 13A is temporarily welded inside the opening portion 14A of the outer bag leaving an opening in the mounting portion 13B of the discharge port 12.
  • a welding tool receiver is inserted toward the unsealed opening 13B of the sealing bag 13, and point sealing is performed with the external welding tool. That is, the welding tool having a welded part shape conforming to the shape of the point seal part and the receiver are brought into contact with each other via the film slice constituting the drug storage bag 10 and the film slice constituting the sealing bag 13, and the drug Point seal (high temperature welding at small area 30) between inner surface of storage bag 10 and outer surface of sealing bag 13 is performed
  • the discharge port 12 is inserted toward the non-welding opening of the sealing bag 13 as indicated by the arrow f in (b), and welding is performed from the outside of the medicine storage bag 10. Therefore, the unsealed portion 14A of the synthetic resin film section constituting the medicine storage bag 10 is heat-pressed against the outer periphery of the discharge port 12 through the unsealed portion of the synthetic resin film constituting the sealing bag 13. The sealing bag 10 is welded to the discharge port 12 through the sealing bag 13.
  • (0018) (c) shows the state after the discharge port 12 is welded. In this state, the weak seal portion 18 shown in FIG. 1 is welded and the compartments 20 and 22 are filled with chemicals and the filling port is sealed. The multi-chamber container of the present invention is completed.
  • FIG. 5 shows a point seal method according to another embodiment.
  • a sealed bag 13 having a welded seal bag 13 is first prepared as a discharge port 12.
  • the medicine storage bag 10 has an unwelded portion 14A left on the outer peripheral strong seal portion 14, and this unwelded portion forms an opening, and the sealing bag 13 is stored in the medicine through the unsealed opening. Insert into bag 10 (Fig. 5 (b)). Then, the unwelded portion 14B is welded to the discharge port 12, and the strong seal portion 14 on the entire circumference is completed. Then, as shown in (c), point sealing is performed, and the medicine storage bag 10 and the sealing bag 13 are welded at a rectangular small area portion 30 on the opposing surface.
  • the welding tool is arranged so that the medicine storage bag 10 and the inner sealing bag 13 are sandwiched from the outside, and the welding tool is crimped via the inner and outer bags, so that the inner surface of the medicine storage bag 10 and the medicine storage bag It is performed so that 10 outer surfaces are welded in a small area.
  • the discharge port 12 is provided with a point seal receiving plate 50 protruding into the internal cavity of the sealing bag 13 as shown in FIG. Can be used.
  • the point seal tool receiving plate 50 is somewhat wider than the inner diameter of the discharge port 12, and includes a substrate portion 50-1 and a receiving plate portion 50-2 orthogonal to the substrate portion 50-1.
  • the part 50-1 is press-fitted and fixed to a groove part 52 formed in the diameter opposite position on the inner diameter part of the discharge port 12.
  • the point seal device receiving plate 50 is made of a material that is difficult to weld to the synthetic resin film constituting the inner and outer nogs.
  • Point sealing is performed so that the medicine storage bag 10 and the inner bag 13 are sandwiched by the welding tool from the outside via the receiving plate portion 50-2. Therefore, it is possible to efficiently perform point sealing in a small area between the inner surface of the drug storage bag 10 and the outer surface of the inner sealing bag 13, and a sufficient flow path for the drug is secured because a gap remains. can do
  • the force at which the opposing surfaces of the medicine storage bag 10 and the inner bag 13 are connected only by a point seal is added to the discharge port 12 in addition to the point seal 30.
  • the heat seal portion 42 is not torn or difficult to break. Therefore, the inner bag 13 remains joined to the drug storage bag 10 as a whole, that is, the inflated bag shape is maintained and only the portion of the point seal 30 is opened.
  • the hollow force can also ensure a smooth flow of the chemical solution toward the discharge port 12 through the inner bag 13 through the opening where the point seal 30 is broken.
  • the medicine storage bag 10 and the inner bag 13 are joined to each other by a pair of point seals 30 on the upper and lower opposing surfaces.
  • the point seal 30 that joins the opposing surfaces of the hook 13 is provided only on one of the upper and lower surfaces in FIG. 2, and the other opposing surface is a heat seal part that covers substantially the entire width where stress concentration is unlikely to occur. You may make it join by.
  • the drug storage bag 10 is opened only by rupturing only the point seal on one side, and the other heat seal is not ruptured. Since the opposite surfaces of 13 remain bonded, the inner bag 13 is not easily crushed as in FIG. 8, and the smooth chemical flow through the opening formed by the tear at the point seal portion is the same. 1 ⁇ 2 can be kept.

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

Abstract

A drug storing bag (10) made of a soft synthetic resin film material the inner space of which is divided into multiple chambers (20, 22) by a weak seal part (18) and in which a discharge aperture (12) is formed in such a manner as to open toward one chamber (20). A sealing bag (13) having a small capacity is provided within the drug storing bag (10) so that the sealing bag (13) seals the opening end of the discharge aperture (12) toward the inner space of the drug storing bag (10). A synthetic resin film that is more fragile than the synthetic resin film constituting the drug storing bag (10) is selected as the material constituting the sealing bag (13). The inner face of the drug storing bag (10) is strongly melt-bonded to the inner face of the sealing bag (13) at a rectangular part which has a sharp corner shape with a small area. When the weak seal part is unsealed, the outer bag is enlarged due to a fluid pressure applied thereto, which results in the burst and opening of the inner bag.

Description

複室容器  Multi-chamber container
技術分野  Technical field
[0001] 本発明は、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、使用時に弱シール部を開通させること で薬剤を混合し、排出させるようにした複室容器に関する。  [0001] According to the present invention, the internal cavity is separated by the weak seal portion, thereby forming a plurality of compartments for individually storing and storing the drug, and opening the weak seal portion during use. The present invention relates to a multi-chamber container that is mixed and discharged.
背景技術  Background art
[0002] 点滴や透析などのための複室容器として多液混合型のものがある。複室容器にお いては、軟弱フィルムを素材とする薬剤収納袋の内部空洞は弱シール部によってそ れぞれ異なった薬液を収容する複数の隔室に分離されて!ヽる。薬剤収納袋の外周 には、その形状を維持しうる剛性のあるプラスチック成型品としての薬液排出口が設 けられ、薬液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 口している力 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 薬剤収納袋を外側力 加圧することによって弱シール部が開通せしめられ、薬剤収 納袋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、薬剤収納袋よりの薬液の投与が可能となる。従って、この種の複 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を行うことにより両液を 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薬液排 出口におけるゴム栓の穿刺を行うと、薬液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、 薬剤収納袋の内部空洞を二つの隔室に分離する第 1の弱シール部に加えて、薬液 排出口の直前に第 2の弱シール部を設け、第 1の弱シール部の開通に要する圧力に 対して第 2の第 2の弱シール部を同等若しくはそれ以上とすることにより、第 1の弱シ ール部次 、で第 2の弱シール部の順序で開通されるようにし、これにより薬液の混合 後に排出が行われるようにしたものが提案されて ヽる(特許文献 1参照)。  [0002] There are multi-liquid mixing type multi-chamber containers for infusion and dialysis. In a multi-chamber container, the internal cavity of a medicine bag made of a soft film is separated into a plurality of compartments each containing a different chemical solution by a weak seal. The outer periphery of the medicine storage bag is provided with a chemical liquid discharge port as a rigid plastic molded product capable of maintaining its shape, the chemical liquid discharge port is formed in a cylindrical shape, and the internal cavity is at one end on one side. Force opening to the chamber The other end has a rubber stopper. Prior to administration of the drug solution to the patient, the weak seal part is opened by applying external force to the drug storage bag, and the internal cavity of the drug storage bag becomes a single chamber. The puncture needle can be used to puncture a rubber stopper, allowing the drug solution to be administered from the drug storage bag. Therefore, in this type of multi-chamber container, it is essential to open the weak seal part by mixing the two liquids prior to the administration of the chemical liquid. On the other hand, it is necessary to discharge the chemical liquid without opening the weak seal part. When the rubber stopper was punctured at the outlet, there was a possibility of an erroneous operation in which only the drug solution in the compartment on the drug solution outlet side was administered. As a conventional technique for dealing with this problem, in addition to the first weak seal portion that separates the internal cavity of the medicine storage bag into two compartments, a second weak seal portion is provided immediately before the chemical solution discharge port. By making the second second weak seal part equal to or higher than the pressure required to open the first weak seal part, the second weak seal part is placed next to the first weak seal part. It has been proposed to open the doors in order so that discharge is performed after mixing of the chemicals (see Patent Document 1).
特許文献 1:特開平 9 327498号公報  Patent Document 1: Japanese Patent Laid-Open No. 9 327498
発明の開示 発明が解決しょうとする課題 Disclosure of the invention Problems to be solved by the invention
[0003] 特許文献 1の技術は二つの隔室を分離する第 1の弱シール部に加えて薬液排出 口の直前に第 2の弱シール部を設け、これらの弱シール部を順次開通させることで未 混合のままの薬液の投与を防止しょうとしている力 弱シール部を 2個所設けている ため、製造工程が複雑化し、また、強度の異なる複数の弱シールを精度よく製造する ことは非常に難度の高いものであり、コスト増となり、ユーザ側に 2段階の加圧による 開通作業を強いることになり、作業性としては必ずしも良くな力つた。また、薬剤収納 袋の加圧の仕方によっては第 1の弱シール部→第 2の弱シール部の順序によって必 ずしも開通されるとは限らず、薬液排出口側の第 2の弱シール部が先に開通されてし まうと、投与作業にそのまま移行してしまう可能性があり、この場合は未混合で 1液の み投与されてしまう結果となって 、た。  [0003] In the technique of Patent Document 1, in addition to the first weak seal portion that separates the two compartments, a second weak seal portion is provided immediately before the chemical solution outlet, and these weak seal portions are sequentially opened. The strength of trying to prevent the administration of unmixed chemicals is provided with two weak seals, which complicates the manufacturing process and makes it very difficult to accurately manufacture multiple weak seals with different strengths. This is a difficult task, increases costs, and forces the user to perform two-stage pressurization work, which is always good for workability. In addition, depending on the method of pressurizing the medicine storage bag, the first weak seal part → the second weak seal part may not always be opened, but the second weak seal part on the chemical solution outlet side is not necessarily opened. If the part is opened first, there is a possibility of shifting to the administration work as it is, and in this case, only one solution is administered without mixing.
[0004] この発明は以上の問題点に鑑みてなされてものであり、未開通の状態では投与を 行 、得な 、複室容器の新規な構造を提供し、製造コストが低廉でありかつユーザ側 の作業性が良好であるにもかかわらず、未混合のままで投与が行われてしまうという 誤操作の可能性をより確実に排除することを目的とする。  [0004] The present invention has been made in view of the above-mentioned problems. Administration is performed in an unopened state, and a novel structure of a multi-chamber container is provided. The purpose is to more surely eliminate the possibility of erroneous operation in which administration is performed in an unmixed state despite good side workability.
課題を解決するための手段  Means for solving the problem
[0005] この発明になる混合型薬剤封止袋状物は、可撓性フィルムにて形成された薬剤収 納袋と、薬剤の排出のための排出口と、薬剤収納袋の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し、薬剤収納袋に外部より印加される押圧力によ り開封され、それぞれの隔室に収納された薬剤の混合を行わしめる弱シール部とを 備えて 、る。薬剤収納袋を構成する可撓性フィルムより脆弱な可撓性フィルムにて形 成され、薬剤収納袋の内部に位置する封止袋は、薬剤収納袋の内部空洞への薬剤 収納袋の前記隔室への開口端を閉鎖するように排出口を包囲配置され、薬剤収納 袋の内面は封止袋の対向外面と小面積部分にて溶着接合されて開封部を構成し、 開封時の前記押圧力による薬剤収納袋の拡開により封止袋は前記開封部にて破壊 せしめられて、排出口は薬剤収納袋の内部空洞に開口せしめられ、混合薬剤が排 出口より排出される。開封部としては鋭角部とすることにより、応力集中を起こさせ、 弱シール部開通により発生された流体圧力により封止袋を確実に破裂に至らしめる ことができる。 [0005] The mixed drug-sealed bag-like material according to the present invention includes a drug storage bag formed of a flexible film, a discharge port for discharging the drug, and an internal cavity of the drug storage bag. A weak seal portion that separates into a plurality of compartments for storing the medicines, is opened by a pressing force applied to the medicine storage bag from the outside, and mixes the medicines stored in the respective compartments. It is equipped with. The sealing bag, which is formed of a flexible film that is more fragile than the flexible film that constitutes the medicine storage bag and is located inside the medicine storage bag, is provided in the space between the medicine storage bag and the inner space of the medicine storage bag. The outlet is surrounded and disposed so as to close the open end to the chamber, and the inner surface of the medicine storage bag is welded and joined to the opposite outer surface of the sealing bag at a small area to form an opening portion, and the pressing at the time of opening is performed. As the drug storage bag is expanded by pressure, the sealing bag is broken at the opening, the discharge port is opened in the internal cavity of the drug storage bag, and the mixed drug is discharged from the discharge port. By making the opening part an acute angle part, stress concentration is caused and the sealing bag is surely ruptured by the fluid pressure generated by opening the weak seal part. be able to.
発明の効果  The invention's effect
[0006] 排出口は薬剤収納袋の内部の封止袋により通常は閉鎖されており、封止袋は薬剤 収納袋の対向面と小面積部分としての開封部にて強固に溶着接合されている。その ため、封止袋を構成する合成樹脂フィルムの材質や厚みや開封部の大きさや開封 部の形状等を適宜選定することにより混合操作時の内部流体圧力により封止袋のみ を確実に破壊せしめて、混合後の薬剤を排出口より排出させることができる。 2液を混 合すべき隔離シール (弱シール)と、混合薬剤の投与を防止する開封部を別の機構 による開通構造とすることにより、確実な〃段階的"連通を遂行させることができるもの である。  [0006] The discharge port is normally closed by a sealing bag inside the medicine storage bag, and the sealing bag is firmly welded and joined to the opposite surface of the medicine storage bag at the opening portion as a small area portion. . Therefore, by appropriately selecting the material and thickness of the synthetic resin film constituting the sealing bag, the size of the opening portion, the shape of the opening portion, etc., the internal fluid pressure during the mixing operation can reliably destroy only the sealing bag. Thus, the mixed drug can be discharged from the discharge port. The separation seal (weak seal) that should be mixed with the two liquids and the opening part that prevents the administration of the mixed drug to be opened by a separate mechanism can achieve reliable “step-by-step” communication. It is.
図面の簡単な説明  Brief Description of Drawings
[0007] [図 1]図 1はこの発明の複室容器の平面図(図 2の I方向矢視図)である。 [0007] FIG. 1 is a plan view of the multi-chamber container of the present invention (a view taken in the direction of arrow I in FIG. 2).
[図 2]図 2はこの発明の複室容器の断面図であり、図 1の II II線に沿って現される矢 視図である。  [FIG. 2] FIG. 2 is a cross-sectional view of the multi-chamber container of the present invention, and is a view taken along the line II-II in FIG.
[図 3]図 3は図 2における排出口付近の部分図であり、この発明の複室容器の開封時 の状態を模式的に示して 、る。  [FIG. 3] FIG. 3 is a partial view of the vicinity of the discharge port in FIG. 2 and schematically shows the state when the multi-chamber container of the present invention is opened.
[図 4]図 4はポイントシール方法の一例を一連の工程にて示す概略図である。  FIG. 4 is a schematic view showing an example of a point seal method in a series of steps.
[図 5]図 5は図 4はポイントシール方法の別の一例を一連の工程にて示す概略図であ る。  [FIG. 5] FIG. 5 is a schematic view showing another example of the point sealing method in FIG. 4 in a series of steps.
[図 6]図 6はポイントシール支持板を具備した内部バッグ装着済の排出口を示す。  [FIG. 6] FIG. 6 shows a discharge port with an internal bag mounted with a point seal support plate.
[図 7]図 7は図 6において、排出口に対するポイントシール支持板の装着状態を模式 的に示す斜視図である。  FIG. 7 is a perspective view schematically showing a state in which the point seal support plate is attached to the discharge port in FIG.
[図 8]図 8は、ポイントシールに加えて、薬剤収納袋 10と内側バッグ 13の対向面を実 質的全幅のヒートシール部にて接続した別実施形態における複室容器の排出口付 近の部分図である。  [FIG. 8] FIG. 8 shows the vicinity of the discharge port of the multi-chamber container in another embodiment in which the opposing surfaces of the drug storage bag 10 and the inner bag 13 are connected by a substantially full-width heat seal portion in addition to the point seal. FIG.
符号の説明  Explanation of symbols
[0008] 10· ··薬剤収納袋 [0008] 10 ··· Drug storage bag
12…排出口 13…封止袋 12 ... Discharge port 13… Sealing bag
18…弱シール部  18 ... Weak seal
20, 22…隔室  20, 22 ...
30…小面積部分 (ポイントシール)  30… Small area (point seal)
50…ポイントシール具受板  50 ... Point seal receiving plate
発明を実施するための最良の形態  BEST MODE FOR CARRYING OUT THE INVENTION
[0009] 図 1〜図 2において、複室容器は薬剤の収納のための平坦状の薬剤収納袋 (外部 バッグ) 10と、薬剤収納袋 10の外周部に固定される排出口 12と、薬剤収納袋 10の 内部空洞に対して排出口 12を通常状態において封止する小容積の封止袋(内部バ ッグ) 13と力も構成される。薬剤収納袋 10は厚さ 200ミクロンといったポリプロピレンフ イルムやポリエチレンフィルムなどの多層構造の軟弱フィルム (本発明の可撓性素材) を素材とする。 2枚の合成樹脂フィルム切片はその外周にてその軟ィ匕温度より十分高 い高温 (ポリプロピレンの場合は 120°C)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、実質的に矩形の袋状をなしている。この薬剤収納袋 10は、 上記のようなフィルムからの製袋によるものの他に、チューブ状インフレーションフィル ムカもの製袋や、ブロー成形〖こよる容器とすることもできる。強シール部 14には懸垂 孔 16が穿設され、この懸垂孔 16によって薬剤収納袋 10を点滴台などに吊り下げ保 持し、点滴や透析作業を行うことになる。  In FIG. 1 to FIG. 2, the multi-chamber container is a flat medicine storage bag (external bag) 10 for storing medicine, a discharge port 12 fixed to the outer periphery of the medicine storage bag 10, and a medicine. A force is also configured with a small-capacity sealing bag (inner bag) 13 that seals the outlet 12 in the normal state against the inner cavity of the storage bag 10. The drug storage bag 10 is made of a soft film (a flexible material of the present invention) having a multilayer structure such as a polypropylene film or a polyethylene film having a thickness of 200 microns. Two pieces of synthetic resin film are sealed at the outer periphery with a strong seal 14 formed by pressing at a high temperature (120 ° C in the case of polypropylene) sufficiently higher than the soft temperature. And has a substantially rectangular bag shape. This medicine storage bag 10 can be a bag made of tube-like inflation film or a container made of blow-molded bag, in addition to the above-described bag-making from a film. A suspension hole 16 is formed in the strong seal portion 14, and the medicine storage bag 10 is suspended and held by the suspension hole 16 on an infusion stand or the like to perform infusion or dialysis.
[0010] 薬剤収納袋 10の長さ方向における中間部位にぉ 、て全幅にわたって弱シール部  [0010] A weak seal portion across the entire width of the intermediate portion in the length direction of the medicine storage bag 10
(剥離可能溶着部) 18が延びており、弱シール部 18によって薬剤収納袋 10の表裏 対抗内面が溶着され、薬剤収納袋 10の内部空洞は第 1隔室 20と第 2隔室 22とに区 画される。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は薬剤収納袋 10を形成する合成樹脂フィルム切片の表裏面をその 軟化温度よりやや高い低温 (ポリプロピレンの場合は 110°C)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収納袋 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、弱シール部 18を流体圧 (加圧時の薬液の圧力)にて破 壊'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。 [0011] 排出口 12は、その形態を維持しうる剛性を有した肉厚を有した合成樹脂 (薬剤収 納袋 10との密着性を得るため薬剤収納袋 10と同一プラスチック素材とするのが好ま しい)の成形品である。排出口 12は両端で開口し、中間がテーパ部 12-1をなし、上 端にフランジ部 12-2 (図 1)を有した筒状に形成される。フランジ部 12-2にはキャップ 1 2-3が突当溶着され、キャップ 12-3の底面開口部にはゴム製内蓋 12-4 (本発明の栓 体)が装着される。点滴などの輸液時には輸液セットの穿刺針により内蓋 12-4を穿刺 し、薬剤収納袋 10の内部空洞を輸液チューブに連通させ、輸液を行うことになる。こ の実施形態にぉ 、ては、薬剤収納袋 10の表裏面を形成する合成樹脂フィルムは封 止袋 13の表裏面を形成する合成樹脂フィルムを介して排出口 12の筒状部を上下よ り挟みつつ加熱密着され、これにより排出口 12に対する薬剤収納袋 10の封止が行 われている。 (Peelable weld part) 18 extends, and the weak seal part 18 welds the front and back surfaces of the medicine storage bag 10 to each other, and the inner cavity of the medicine storage bag 10 is divided into the first compartment 20 and the second compartment 22. It is divided. 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 surfaces of the synthetic resin film section forming the drug storage bag 10 at a low temperature (110 ° C. in the case of polypropylene) slightly higher than its softening temperature. Therefore, the strong seal portion 14 remains as it is by pressurizing the drug solution in the drug storage bag 10 from the outside in the compartments 20 and 22 while the respective drug solutions are stored in the first compartment 20 and the second compartment 22. In addition, the weak seal portion 18 can be broken and opened by fluid pressure (pressure of the chemical solution during pressurization) to mix the first chemical solution and the second chemical solution. [0011] The discharge port 12 is made of a synthetic resin having a thickness and rigidity capable of maintaining its form (the same plastic material as the drug storage bag 10 is used to obtain adhesion to the drug storage bag 10). (Preferred). The discharge port 12 is formed in a cylindrical shape having openings at both ends, the middle forming a tapered portion 12-1, and the upper end having a flange portion 12-2 (FIG. 1). The cap 12-3 is abutted and welded to the flange 12-2, and the rubber inner lid 12-4 (the plug of the present invention) is attached to the bottom opening of the cap 12-3. At the time of infusion such as infusion, the inner lid 12-4 is punctured by the puncture needle of the infusion set, and the inner cavity of the medicine storage bag 10 is communicated with the infusion tube to perform infusion. In this embodiment, the synthetic resin film that forms the front and back surfaces of the medicine storage bag 10 is moved up and down the cylindrical portion of the discharge port 12 through the synthetic resin film that forms the front and back surfaces of the sealing bag 13. Heating and adhering while sandwiching, the medicine storage bag 10 is sealed with respect to the discharge port 12.
[0012] 図 1及び 2に示すように、小容積の封止袋 13は薬剤収納袋 10の内部に設けられ、 排出口 12を通常時において封止するため設けられる。封止袋 13は薬剤収納袋 10と 同様にポリプロピレンフィルムやポリエチレンフィルムのような上下の 2枚の合成樹脂 フィルム切片を外周部 13Aにて高温 (薬剤収納袋 10の強シール部 14の溶着温度と 同等の温度)にて溶着することにより形成されるが、後述のように、弱シール 18の開 封時の流体圧力による薬剤収納袋 10の拡開によってポイントシール部で破裂せしめ られるように、封止袋 13を構成する合成樹脂フィルムは強度的には薬剤収納袋 10を 構成する合成樹脂フィルムより適当に脆弱とされている。他方、ポイントシール時の熱 圧着性からみると内外のバッグは素材としては同一の合成樹脂素材であるのが好ま しぐ所望の強度差を持たせるため封止袋 13を構成する合成樹脂フィルムの厚みを 、薬剤収納袋 10を構成する合成樹脂フィルムのそれより適当に薄くすることができる 。または、薬剤収納袋 10を構成する合成樹脂の重合度を封止袋 13を構成する合成 榭脂の重合度より小さくしたり、コーポリマーとするなどの手段により内外のバッグ間 で必要な強度差を持たせるようにすることができる。また、封止袋 13には、点滴速度 に比して非常に遅い流速の液体が通過できるような微小な孔を穿設することによる封 止袋 13内の湿熱下の減菌(無菌ィ匕)操作に有利である。このため、ポイントシール部 をミシン目状とすることにより、ポイントシール時に同時に穿孔することもできる。尚、 図 2ではバッグ 10, 13は相当な厚みを持たせて描いている力 これは作図の便宜上 であって、厚みにつ 、ては相当に誇張して描かれて 、る点に留意された!、。 As shown in FIGS. 1 and 2, the small-capacity sealing bag 13 is provided inside the medicine storage bag 10 and is provided to seal the discharge port 12 in a normal state. The sealing bag 13 is similar to the drug storage bag 10 in that the upper and lower synthetic resin film sections, such as polypropylene film and polyethylene film, are heated at the outer peripheral portion 13A (the welding temperature of the strong seal portion 14 of the drug storage bag 10). It is formed by welding at the same temperature), but as described later, it is sealed so that it can be ruptured at the point seal part by opening the medicine storage bag 10 by the fluid pressure when opening the weak seal 18. The synthetic resin film constituting the stopper bag 13 is considered to be weaker than the synthetic resin film constituting the drug storage bag 10 in terms of strength. On the other hand, from the viewpoint of thermocompression bonding at the time of point sealing, it is preferable that the inner and outer bags are made of the same synthetic resin material. The thickness can be made appropriately thinner than that of the synthetic resin film constituting the medicine storage bag 10. Alternatively, the required strength difference between the inner and outer bags can be reduced by making the polymerization degree of the synthetic resin constituting the drug storage bag 10 smaller than the polymerization degree of the synthetic resin constituting the sealing bag 13 or by using a copolymer. Can be provided. In addition, the sealing bag 13 is sterilized under the heat and humidity in the sealing bag 13 by assembling a microscopic hole through which a liquid having a flow rate very slow compared to the drip rate can pass (aseptic sterilization). ) It is advantageous for operation. For this reason, by making the point seal portion into a perforated shape, it is possible to drill at the same time as the point seal. still, In Fig. 2, it is noted that the bags 10 and 13 are drawn with a considerable thickness. This is for the convenience of drawing, and the thickness is drawn with exaggeration considerably! ,.
封止袋 13は、図 1に示すように、排出口 12の外径より幾分大きな幅を持ち、薬剤収 納袋 10の内部空洞に向けて延びており、薬剤収納袋 10の未開通時 (弱シール部 1 8により隔室 20, 22が分離状態時)に、薬剤収納袋 10の内部空洞に対して排出口 12 を閉鎖することにより、薬液が未混合で排出口 12より排出されるのを阻止する。そし て、隔室 20, 22の薬剤の混合のため弱シール部 18を開口させるベく薬剤収納袋 10 を、なるべくは排出口 12から離間側の隔室 20において加圧したときに薬剤収納袋 1 0の内部に生ずる衝撃的薬液流(図 3の矢印 F)による薬剤収納袋 10の拡開により封 止袋 13の破断が惹起せしめられ、薬剤を収納した薬剤収納袋 10の内部空洞が排 出口 12に連通せしめられ、排出口 12からの混合薬液の排出が可能となる。そして、 この実施形態においては、後述のように封止袋 13は薬剤収納袋 10と共に排出口 12 に取り付けられている。即ち、薬剤収納袋 10の外周における強シール部 14は部分 1 4-1において排出口 12の外周に溶着されている力 この溶着時に封止袋 13の外周 部 13-1も重ねて溶着されるようになっている(図 2参照)。他方、封止袋 13は薬剤収 納袋 10の内部空洞(隔室 22)に対しては通常は、即ち、弱シール部 18の未開通時 、閉鎖されることにより薬剤収納袋 10内の薬剤が排出口 12に向かうのを阻止してい る。そして、封止袋 13はその外面が薬剤収納袋 10の対向内面(上下内面)に小面積 部分 30にて溶着 (ポイントシール)されている。封止袋 13の外面を薬剤収納袋 10の 対向内面に溶着するこの小面積部分 30は図 1の斜線領域として示すように尖鋭なコ ーナ一部を有した矩形形状をなしており、溶着温度としては薬剤収納袋 10の外周の 強シール部 14の溶着温度と同等の高温度である。弱シール部 18の開封時に、薬剤 収納袋 10は拡開され、外面が薬剤収納袋 10の対向内面に小面積部分 30にて溶着 されている封止袋 13は上下に引張力を受け、小面積部分 30の溶着が強固であるた め、封止袋 13には引き裂き力が発生し、封止袋 13を構成する合成樹脂フィルムは薬 剤収納袋 10を構成する合成樹脂フィルムより強度的に弱くかつ小面積部分 30の尖 鋭形状によって生ずる応力集中の効果もあって、薬剤収納袋 10の拡開によって封 止袋 13はポイントシール部分 30で強く弓 Iつ張られ、図 3に示すように封止袋 13はポ イントシール部分 30で破裂せしめられ、排出口 12が開通され、薬液の排出が可能と なる。即ち、薬剤収納袋 10の開通のため薬剤収納袋 10は机などの上に図 2のように 平坦に載置され、薬剤収納袋 10は上面より手のひらで矢印 bのように加圧される(図 3に示すように隔室 20側において薬剤収納袋 10を加圧するのが好ましいが隔室 22 の側を加圧しても両側を加圧してもよ ヽ)。薬剤収納袋 10の加圧により弱シール部 1 8に液圧が加わり、所定の圧力により弱シール部 18は瞬時に破壊開通するに至る。 加圧により薬剤収納袋 10の内圧は高められており、弱シール部 18の開通の開通に よりこの高められた圧力が一気に放出されるため、衝撃的な薬液の流れが薬剤収納 袋 10内に惹起される。薬剤収納袋 10内に惹起された衝撃的な薬液の流れを図 3で は矢印 Fにより模式的に示す。弱シール部 18の開通の際に薬剤収納袋 10内に惹起 された急激な薬液の流れ Fは薬剤収納袋 10を図 3に示すように大きく拡開させる。そ のため、薬剤収納袋 10の対向面に小面積部分 30にて強固に溶着された小容積の 封止袋 13には大きな引き裂き力が生じせしめられ、封止袋 13を構成する合成樹脂 フィルムは薬剤収納袋 10を構成する合成樹脂フィルムより引裂き強度が弱いことから 破裂に至らしめることができる。図 3では封止袋 30のポイントシール部分が 13'のよう に薬剤収納袋 10に溶着されたまま引き裂かれ、その結果封止袋 13に開口 40が形 成され、薬剤が矢印のように開口 40を介して排出口 12に向けて流通可能となった状 態を示しており、この状態において、ゴム栓 12-3を図示しない輸液セットの穿刺針に より穿刺することにより混合薬液の排出が可能となる。このように、本発明では 2液を 混合すべき隔離シール (弱シール 18)の開通と、混合薬剤の投与を防止する開封部 (ポイントシール 30)の開通とが別の機構による言わば"段階的〃開通構造されている ため、開通作業時の確実な連通動作を実現させることができる。 As shown in FIG. 1, the sealing bag 13 has a width that is somewhat larger than the outer diameter of the discharge port 12 and extends toward the internal cavity of the drug storage bag 10 when the drug storage bag 10 is not opened. By closing the discharge port 12 with respect to the internal cavity of the drug storage bag 10 when the compartments 20 and 22 are separated by the weak seal portion 18, the drug solution is discharged from the discharge port 12 without mixing. To prevent it. Then, when the medicine storage bag 10 that opens the weak seal portion 18 for mixing the medicines in the compartments 20 and 22 is pressurized in the compartment 20 on the side away from the discharge port 12 as much as possible, the medicine storage bag is used. The opening of the medicine storage bag 10 due to the shocking chemical liquid flow (arrow F in FIG. 3) generated inside the 10 causes the sealing bag 13 to break, and the internal cavity of the medicine storage bag 10 containing the medicine is discharged. The mixture 12 is communicated with the outlet 12, and the mixed chemical solution can be discharged from the outlet 12. In this embodiment, the sealing bag 13 is attached to the discharge port 12 together with the medicine storage bag 10 as described later. That is, the strong seal portion 14 on the outer periphery of the medicine storage bag 10 is welded to the outer periphery of the discharge port 12 in the portion 14-1, and the outer peripheral portion 13-1 of the sealing bag 13 is also overlapped and welded at the time of this welding. (See Figure 2). On the other hand, the sealing bag 13 is normally closed with respect to the internal cavity (compartment 22) of the medicine storage bag 10, that is, when the weak seal portion 18 is not opened, the medicine in the medicine storage bag 10 is closed. Is blocked from going to the outlet 12. The outer surface of the sealing bag 13 is welded (point-sealed) to the opposing inner surface (upper and lower inner surfaces) of the medicine storage bag 10 with a small area portion 30. This small area portion 30 where the outer surface of the sealing bag 13 is welded to the opposite inner surface of the drug storage bag 10 has a rectangular shape with a sharp corner as shown by the hatched area in FIG. The temperature is as high as the welding temperature of the strong seal portion 14 on the outer periphery of the drug storage bag 10. When the weak seal portion 18 is opened, the medicine storage bag 10 is expanded, and the sealing bag 13 whose outer surface is welded to the opposite inner surface of the medicine storage bag 10 with a small area portion 30 receives a tensile force in the vertical direction and is small. Since the welding of the area portion 30 is strong, a tearing force is generated in the sealing bag 13, and the synthetic resin film constituting the sealing bag 13 is stronger than the synthetic resin film constituting the drug storage bag 10. There is also the effect of stress concentration caused by the weak and sharp shape of the small area part 30. As the drug storage bag 10 is expanded, the sealing bag 13 is strongly bowed at the point seal part 30 as shown in Fig. 3. The sealing bag 13 is It is ruptured at the into-seal portion 30 and the discharge port 12 is opened, so that the chemical solution can be discharged. That is, in order to open the medicine storage bag 10, the medicine storage bag 10 is placed flat on a desk or the like as shown in FIG. 2, and the medicine storage bag 10 is pressurized with a palm from the top as shown by an arrow b ( As shown in FIG. 3, it is preferable to pressurize the medicine storage bag 10 on the compartment 20 side, but the compartment 22 side may be pressurized or both sides may be pressurized. By pressurizing the medicine storage bag 10, a hydraulic pressure is applied to the weak seal portion 18, and the weak seal portion 18 is instantaneously broken and opened by a predetermined pressure. The internal pressure of the medicine storage bag 10 is increased by pressurization, and this increased pressure is released at once by opening and closing the weak seal portion 18, so that a shocking flow of the chemical solution flows into the medicine storage bag 10. Induced. In FIG. 3, the flow of the shocking chemical liquid induced in the medicine storage bag 10 is schematically shown by an arrow F. The rapid flow F of the chemical solution induced in the medicine storage bag 10 when the weak seal portion 18 is opened causes the medicine storage bag 10 to be greatly expanded as shown in FIG. Therefore, a large tearing force is generated in the small-capacity sealing bag 13 firmly welded to the opposite surface of the medicine storage bag 10 at the small area portion 30, and the synthetic resin film constituting the sealing bag 13. Since the tear strength is weaker than that of the synthetic resin film constituting the drug storage bag 10, it can be ruptured. In FIG. 3, the point seal portion of the sealing bag 30 is torn while it is welded to the medicine storage bag 10 as shown by 13 '. As a result, an opening 40 is formed in the sealing bag 13, and the medicine opens as indicated by an arrow. In this state, the rubber plug 12-3 is punctured with a puncture needle of an infusion set (not shown) to discharge the mixed drug solution. It becomes possible. In this way, according to the present invention, the opening of the isolation seal (weak seal 18) to be mixed with the two liquids and the opening of the opening (point seal 30) for preventing the administration of the mixed drug are said to be “stepwise”. 〃 Because of the opening structure, it is possible to achieve reliable communication during opening work.
小面積部分 30の鋭角の矩形形状は応力集中効果によって封止袋 13の破裂をより 確実に惹起せしめることに寄与させることができる。そして、封止袋 13を構成する合 成榭脂フィルムの組成や肉厚等を最適設定することで、薬剤収納袋の未開通時 (弱 シール部 18の閉鎖時)における排出口 12への薬剤の流入阻止(封止袋 13による排 出口 12の閉鎖状態の維持)を確実に行いつつ、薬剤収納袋の開通時 (弱シール部 18の開通時)における内部バック 13の確実な破裂による薬剤の排出が可能となるよ うにすることができる。 The acute rectangular shape of the small area portion 30 can contribute to causing the sealing bag 13 to burst more reliably due to the stress concentration effect. Then, by optimally setting the composition and thickness of the synthetic resin film constituting the sealing bag 13, the medicine to the outlet 12 when the medicine storage bag is not opened (when the weak seal 18 is closed) is used. Inflow prevention (maintaining the closed state of the outlet / outlet 12 by the sealing bag 13), while the drug storage bag is opened (when the weak seal 18 is opened) It can be discharged Can be done.
[0015] 薬剤収納袋 10の封止によるこの発明の複室容器の形成工程の一例について図 4 により説明すると、薬剤収納袋 10を形成する上下合成樹脂フィルムは (a)のように外 周の強シール部 14が部位 14Aにおいて未溶着であり、この未溶着部位で開口部を 呈している。封止袋 13は薬剤収納袋 10の内部に既に収容されており、外周部 13A は排出口 12の装着部位 13Bに開口を残して外部バッグの開口部位 14Aの内側に 仮溶着されている。  An example of the process for forming the multi-chamber container of the present invention by sealing the medicine storage bag 10 will be described with reference to FIG. 4. The upper and lower synthetic resin films forming the medicine storage bag 10 are arranged on the outer periphery as shown in (a). The strong seal portion 14 is not welded at the portion 14A, and an opening is exhibited at the unwelded portion. The sealing bag 13 is already stored in the medicine storage bag 10, and the outer peripheral portion 13A is temporarily welded inside the opening portion 14A of the outer bag leaving an opening in the mounting portion 13B of the discharge port 12.
[0016] 次に、封止袋 13の未封止開口部 13Bに向けて溶着具の受具が挿入され、外部の 溶着具との間でポイントシールが行われる。即ち、ポイントシール部の形状に準じた 溶着部形状を有する溶着具と受具とは薬剤収納袋 10を構成するフィルム切片及び 封止袋 13を構成するフィルム切片を介して当接せしめられ、薬剤収納袋 10の内面と 封止袋 13の外面との間のポイントシール (小面積部分 30での高温溶着)が行われる  [0016] Next, a welding tool receiver is inserted toward the unsealed opening 13B of the sealing bag 13, and point sealing is performed with the external welding tool. That is, the welding tool having a welded part shape conforming to the shape of the point seal part and the receiver are brought into contact with each other via the film slice constituting the drug storage bag 10 and the film slice constituting the sealing bag 13, and the drug Point seal (high temperature welding at small area 30) between inner surface of storage bag 10 and outer surface of sealing bag 13 is performed
[0017] そして、排出口 12が (b)の矢印 fのように封止袋 13の未溶着開口部に向けて挿入 され、薬剤収納袋 10の外側より溶着が行われる。そのため、薬剤収納袋 10を構成す る合成樹脂フィルム切片の未封止部 14Aは封止袋 13を構成する合成樹脂フィルム の未封止部を介して排出口 12の外周に対して加熱圧着され、封止袋 10は封止袋 1 3を介して排出口 12に対して溶着される。 Then, the discharge port 12 is inserted toward the non-welding opening of the sealing bag 13 as indicated by the arrow f in (b), and welding is performed from the outside of the medicine storage bag 10. Therefore, the unsealed portion 14A of the synthetic resin film section constituting the medicine storage bag 10 is heat-pressed against the outer periphery of the discharge port 12 through the unsealed portion of the synthetic resin film constituting the sealing bag 13. The sealing bag 10 is welded to the discharge port 12 through the sealing bag 13.
[0018] (c)は排出口 12の溶着後の状態を示し、この状態において図 1の弱シール部 18の 溶着形成並びにその後の隔室 20, 22への薬剤充填及び充填口のシールが行われ、 この発明の複室容器が完成する。  (0018) (c) shows the state after the discharge port 12 is welded. In this state, the weak seal portion 18 shown in FIG. 1 is welded and the compartments 20 and 22 are filled with chemicals and the filling port is sealed. The multi-chamber container of the present invention is completed.
[0019] 図 5は別実施形態のポイントシール方法を示しており、(a)に示すように排出口 12と して、封止袋 13を溶着済みのものを先に準備する。薬剤収納袋 10は外周の強シー ル部 14に未溶着部 14Aを残しており、この未溶着部分が開口部をなしており、この 未シールの開口部を介して封止袋 13を薬剤収納袋 10に挿入する(図 5 (b) )。そして 、排出口 12に対して未溶着部 14Bの溶着が行われ、全周での強シール部 14が完成 する。そして、(c)で示すようにポイントシールが行われ、薬剤収納袋 10と封止袋 13 とは対向面における矩形の小面積部分 30にて溶着される。この場合のポイントシー ルは薬剤収納袋 10及びその内側の封止袋 13を外側より挟むように溶着具を配置し 、溶着具を内外のバッグを介して圧着することで、薬剤収納袋 10の内面と薬剤収納 袋 10の外面とを小面積にて溶着するように行われる。 FIG. 5 shows a point seal method according to another embodiment. As shown in FIG. 5A, a sealed bag 13 having a welded seal bag 13 is first prepared as a discharge port 12. The medicine storage bag 10 has an unwelded portion 14A left on the outer peripheral strong seal portion 14, and this unwelded portion forms an opening, and the sealing bag 13 is stored in the medicine through the unsealed opening. Insert into bag 10 (Fig. 5 (b)). Then, the unwelded portion 14B is welded to the discharge port 12, and the strong seal portion 14 on the entire circumference is completed. Then, as shown in (c), point sealing is performed, and the medicine storage bag 10 and the sealing bag 13 are welded at a rectangular small area portion 30 on the opposing surface. Point sea in this case The welding tool is arranged so that the medicine storage bag 10 and the inner sealing bag 13 are sandwiched from the outside, and the welding tool is crimped via the inner and outer bags, so that the inner surface of the medicine storage bag 10 and the medicine storage bag It is performed so that 10 outer surfaces are welded in a small area.
[0020] 図 5の実施形態におけるポイントシールの溶着性の改善を図るため排出口 12として 、図 6に示すように封止袋 13の内部空洞に突出するポイントシール具受板 50を備え たものを使用することができる。ポイントシール具受板 50は図 7に示すように、排出口 12の内径より幾分広 、基板部 50-1と、基板部 50-1に直交する受板部 50-2とを備え、 基板部 50-1は排出口 12の内径部分に直径対立位置に形成された溝部 52に圧嵌固 定せしめられる。ポイントシール具受板 50内外のノッグを構成する合成樹脂フィルム に対して溶着しにく 、材質とする。ポイントシールは薬剤収納袋 10及び内側バッグ 1 3を受板部 50-2を介して外側より溶着具により挟むように行われる。そのため、薬剤収 納袋 10の内面と内封止袋 13の外面との対向面間で小面積部分でのポイントシール を効率的に行うことができ、空隙が残るため薬剤の流路を十分確保することができる In order to improve the weldability of the point seal in the embodiment of FIG. 5, the discharge port 12 is provided with a point seal receiving plate 50 protruding into the internal cavity of the sealing bag 13 as shown in FIG. Can be used. As shown in FIG. 7, the point seal tool receiving plate 50 is somewhat wider than the inner diameter of the discharge port 12, and includes a substrate portion 50-1 and a receiving plate portion 50-2 orthogonal to the substrate portion 50-1. The part 50-1 is press-fitted and fixed to a groove part 52 formed in the diameter opposite position on the inner diameter part of the discharge port 12. The point seal device receiving plate 50 is made of a material that is difficult to weld to the synthetic resin film constituting the inner and outer nogs. Point sealing is performed so that the medicine storage bag 10 and the inner bag 13 are sandwiched by the welding tool from the outside via the receiving plate portion 50-2. Therefore, it is possible to efficiently perform point sealing in a small area between the inner surface of the drug storage bag 10 and the outer surface of the inner sealing bag 13, and a sufficient flow path for the drug is secured because a gap remains. can do
[0021] 以上説明の実施形態では薬剤収納袋 10と内側バッグ 13との対向面はポイントシ ールのみで接結されている力 図 8に示すようにポイントシール 30に加え、排出口 12 に近い部位における内側バッグ 13の実質的全幅のヒートシール部(高温溶着部 =本 発明の付加的シール部) 42により薬剤収納袋 10と内側バッグ 13との対向面間を接 結することができる。ヒートシール部 42は幅広になっているため、ポイントシール 30程 強い応力集中は生じない。そのため、弱シール部の開通時の急激な薬液の流れによ る薬剤収納袋 10の拡開時にポイントシール 30の部分で内側バッグ 13は破れても、ヒ ートシール部 42は破れな 、若しくは破れ難!、ため、内側バッグ 13は全体としては薬 剤収納袋 10に接合されたままで、すなわち、膨らんだ袋形状を維持し、ポイントシー ル 30の部分のみ開口せしめられるため、薬剤収納袋 10の内部空洞力もポイントシー ル 30が破れてできた開口部を介して内側バッグ 13を経て排出口 12に向けてのスム ースな薬液の流れを確保することができる。 In the embodiment described above, the force at which the opposing surfaces of the medicine storage bag 10 and the inner bag 13 are connected only by a point seal, as shown in FIG. 8, is added to the discharge port 12 in addition to the point seal 30. The opposed surfaces of the medicine storage bag 10 and the inner bag 13 can be connected by a heat seal portion (high-temperature welded portion = additional seal portion of the present invention) 42 of substantially the full width of the inner bag 13 at a close portion. Since the heat seal part 42 is wide, the stress concentration as strong as the point seal 30 does not occur. For this reason, even if the inner bag 13 is torn at the point seal 30 portion when the medicine storage bag 10 is expanded due to the rapid flow of the chemical solution when the weak seal portion is opened, the heat seal portion 42 is not torn or difficult to break. Therefore, the inner bag 13 remains joined to the drug storage bag 10 as a whole, that is, the inflated bag shape is maintained and only the portion of the point seal 30 is opened. The hollow force can also ensure a smooth flow of the chemical solution toward the discharge port 12 through the inner bag 13 through the opening where the point seal 30 is broken.
[0022] また、図 2に関連して説明したように薬剤収納袋 10と内側バッグ 13とは上下両側の 対向面で一対のポイントシール 30により接合されて 、たが、薬剤収納袋 10と内側バ ッグ 13の対向面を接合するポイントシール 30は図 2の上側及び下側のうちの一方の 対向面のみに設け、他方の対向面は応力集中が生じにくい実質的に全幅に亘るヒ ートシール部にて接合するようにしてもよい。この場合においては、薬剤混合のため 弱シールの開通時の薬剤収納袋 10の拡開は片側のポイントシールのみ破裂開口さ せ、他方のヒートシール部は破裂されず、薬剤収納袋 10と内側バッグ 13の対向面は 接合のままであるため、図 8と同様に内側バッグ 13が潰れ難いため、ポイントシール の部位での破れにより形成された開口部を介してのスムースな薬液の流れも同様に ½保することができる。 In addition, as described in relation to FIG. 2, the medicine storage bag 10 and the inner bag 13 are joined to each other by a pair of point seals 30 on the upper and lower opposing surfaces. Ba The point seal 30 that joins the opposing surfaces of the hook 13 is provided only on one of the upper and lower surfaces in FIG. 2, and the other opposing surface is a heat seal part that covers substantially the entire width where stress concentration is unlikely to occur. You may make it join by. In this case, because of the drug mixing, when the weak seal is opened, the drug storage bag 10 is opened only by rupturing only the point seal on one side, and the other heat seal is not ruptured. Since the opposite surfaces of 13 remain bonded, the inner bag 13 is not easily crushed as in FIG. 8, and the smooth chemical flow through the opening formed by the tear at the point seal portion is the same. ½ can be kept.

Claims

請求の範囲 The scope of the claims
[1] 可撓性フィルムにて形成された薬剤収納袋と、薬剤の排出のため薬剤収納袋に装 着された排出口と、薬剤収納袋内部をそれぞれの薬剤の収納のための複数の隔室 に分離し、それぞれの隔室に収納された薬剤の混合のため薬剤収納袋に外部より印 加される押圧力により剥離開通されるように薬剤収納袋の対向内面を溶着する弱シ ール部と、薬剤収納袋を構成する可撓性フィルムより脆弱な可撓性フィルムにて形成 され、薬剤収納袋の内部に位置して薬剤収納袋内部への排出口の開口端を包囲閉 鎖する封止袋と、薬剤収納袋と封止袋との対向面と小面積領域にて溶着接合してな る開封部とを備え、開封時の前記押圧力による薬剤収納袋の拡開により封止袋は前 記開封部にて破壊せしめられて、排出口を薬剤収納袋内部空洞に連通する開口部 が封止袋に形成される複室容器。  [1] A medicine storage bag formed of a flexible film, a discharge port attached to the medicine storage bag for discharging the medicine, and a plurality of partitions for storing each medicine inside the medicine storage bag. Weak seal that welds the opposite inner surfaces of the drug storage bags so that they are separated and opened by the pressing force applied from the outside to the drug storage bags for mixing the drugs stored in the respective compartments And a flexible film that is more fragile than the flexible film constituting the medicine storage bag, and is located inside the medicine storage bag and surrounds and closes the opening end of the discharge port into the medicine storage bag. A sealing bag, an opening portion formed by welding and bonding in a small area in the opposite surface of the medicine storage bag and the sealing bag, and sealed by opening the medicine storage bag by the pressing force at the time of opening. The bag is broken at the opening, and an opening that connects the discharge port to the internal cavity of the drug storage bag Multiple chambers but which are formed in the sealing bag.
[2] 請求項 1に記載の発明にお 、て、前記開封部は鋭角部を有する形状をなして 、る 複室容器。  [2] The multi-chamber container according to claim 1, wherein the opening portion has a shape having an acute angle portion.
[3] 請求項 1若しくは 2に記載の発明において、排出口は開封部に正対するべく封止 袋の内部に延出する溶着具受板を備えた複室容器。  [3] The multi-chamber container according to claim 1 or 2, wherein the discharge port includes a welder receiving plate extending into the sealing bag so as to face the opening.
[4] 請求項 1から請求項 3のいずれか一項に記載の発明において、前記開封部に加え て、薬剤収納袋と封止袋との対向面間を溶着接合する付加的シール部を備え、前記 付加的シール部は、封止袋の破壊時に封止袋の拡開形状を維持する複室容器。  [4] In the invention according to any one of claims 1 to 3, in addition to the opening portion, an additional seal portion that welds and joins the opposing surfaces of the medicine storage bag and the sealing bag is provided. The additional seal portion is a multi-chamber container that maintains the expanded shape of the sealing bag when the sealing bag is broken.
[5] 可撓性フィルムにて形成された薬剤収納袋と、薬剤の排出のため薬剤収納袋に装 着された排出口と、排出口に設けられた栓体と、薬剤収納袋内部をそれぞれの薬剤 の収納のための複数の隔室に分離し、それぞれの隔室に収納された薬剤の混合の ため薬剤収納袋に外部より印加される押圧力により剥離開通されるように薬剤収納 袋の対向内面を溶着する弱シール部とを備えた複室容器により輸液作業を行う方法 であって、前記排出口に、薬剤収納袋を構成する可撓性フィルムより脆弱な可撓性 フィルムにて形成され、薬剤収納袋の内部に位置して薬剤収納袋内部への排出口 の開口端を包囲閉鎖する封止袋を設け、更に薬剤収納袋と封止袋との対向面を一 体に接合し、通常時は薬剤収納袋内部を排出口に対して実質的に閉鎖するようにし 、輸液の際に薬剤収納袋を外部から加圧することにより惹起される液圧で弱シール 部を剥離させて前記複数の隔室を連通させることにより、第 1及び第 2の隔室の薬剤 を混合させ、弱シール部の剥離により惹起される薬剤収納袋の拡開により封止袋を 破壊させて混合薬剤を排出口に導くようにすると共に、輸液具を栓体に穿刺すること により輸液作業を開始するようにした輸液方法。 [5] A medicine storage bag formed of a flexible film, a discharge opening attached to the medicine storage bag for discharging the medicine, a plug provided in the discharge opening, and the inside of the medicine storage bag The medicine storage bag is separated into a plurality of compartments for storing the medicines, and the medicine storage bags are separated and opened by pressing force applied to the medicine storage bags for mixing the medicines stored in the respective compartments. A method of performing an infusion operation with a multi-chamber container provided with a weak seal portion that welds the opposing inner surface, wherein the discharge port is formed of a flexible film that is more fragile than the flexible film constituting the drug storage bag A sealing bag is provided inside the medicine storage bag to surround and close the open end of the discharge port into the medicine storage bag, and the opposite surfaces of the medicine storage bag and the sealing bag are joined together. Normally, the inside of the medicine bag is substantially closed with respect to the discharge port. Weak seal with fluid pressure caused by pressurizing the medicine bag from outside during infusion By separating the parts and communicating the plurality of compartments, the medicines in the first and second compartments are mixed, and the sealing bag is opened by expanding the medicine storage bag caused by peeling off the weak seal part. An infusion method in which an infusion operation is started by puncturing a stopper with an infusion device while guiding the mixed medicine to the discharge port.
PCT/JP2006/322564 2005-11-14 2006-11-13 Multichamber container WO2007055355A1 (en)

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JP2009000343A (en) * 2007-06-22 2009-01-08 Ajinomoto Co Inc Multi-cell container
US8617133B2 (en) 2007-07-17 2013-12-31 Ajinomoto Co., Inc. Multi-chamber container
WO2019086251A1 (en) * 2017-11-06 2019-05-09 Calbact Ag Calorimeter and sample container for a calorimeter

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JP2005028040A (en) * 2003-07-11 2005-02-03 Medicalseed:Kk Sealing plug for partition bag
WO2005097039A1 (en) * 2004-04-08 2005-10-20 Ajinomoto Co., Inc. Medicine containing sealed body

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JP2003305107A (en) * 2002-02-14 2003-10-28 Otsuka Pharmaceut Factory Inc Medicine discharge member and medical double-chamber container
JP2005028040A (en) * 2003-07-11 2005-02-03 Medicalseed:Kk Sealing plug for partition bag
WO2005097039A1 (en) * 2004-04-08 2005-10-20 Ajinomoto Co., Inc. Medicine containing sealed body

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Publication number Priority date Publication date Assignee Title
JP2009000343A (en) * 2007-06-22 2009-01-08 Ajinomoto Co Inc Multi-cell container
US8617133B2 (en) 2007-07-17 2013-12-31 Ajinomoto Co., Inc. Multi-chamber container
WO2019086251A1 (en) * 2017-11-06 2019-05-09 Calbact Ag Calorimeter and sample container for a calorimeter
CN111194400A (en) * 2017-11-06 2020-05-22 卡尔巴科特公司 Calorimeter and sample container for calorimeter
CN111194400B (en) * 2017-11-06 2022-02-11 卡尔巴科特公司 Calorimeter and sample container for calorimeter
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