JP4298308B2 - Multi-chamber infusion container and manufacturing method thereof - Google Patents

Multi-chamber infusion container and manufacturing method thereof Download PDF

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Publication number
JP4298308B2
JP4298308B2 JP2003023436A JP2003023436A JP4298308B2 JP 4298308 B2 JP4298308 B2 JP 4298308B2 JP 2003023436 A JP2003023436 A JP 2003023436A JP 2003023436 A JP2003023436 A JP 2003023436A JP 4298308 B2 JP4298308 B2 JP 4298308B2
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JP
Japan
Prior art keywords
seal
infusion container
weak
chamber infusion
fusion
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
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JP2003023436A
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Japanese (ja)
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JP2004000476A (en
Inventor
年晴 岩崎
政孝 小谷
喜代和 石渡
克行 吉川
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Hosokawa Yoko KK
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Hosokawa Yoko KK
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Priority to JP2003023436A priority Critical patent/JP4298308B2/en
Priority to TW92107021A priority patent/TWI252203B/en
Priority to EP03745425A priority patent/EP1490207B1/en
Priority to US10/508,481 priority patent/US7776414B2/en
Priority to DE60332710T priority patent/DE60332710D1/en
Priority to CNB038069997A priority patent/CN100344439C/en
Priority to PT03745425T priority patent/PT1490207E/en
Priority to ES03745425T priority patent/ES2344891T3/en
Priority to PCT/JP2003/003854 priority patent/WO2003082549A1/en
Priority to AT03745425T priority patent/ATE468963T1/en
Priority to KR1020047014967A priority patent/KR100659650B1/en
Priority to AU2003226480A priority patent/AU2003226480A1/en
Publication of JP2004000476A publication Critical patent/JP2004000476A/en
Application granted granted Critical
Publication of JP4298308B2 publication Critical patent/JP4298308B2/en
Priority to US12/829,941 priority patent/US20100269972A1/en
Anticipated expiration legal-status Critical
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112—Single lapped joints
    • B29C66/1122—Single lap to lap joints, i.e. overlap joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/20—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/21—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being formed by a single dot or dash or by several dots or dashes, i.e. spot joining or spot welding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/345—Progressively making the joint, e.g. starting from the middle
    • B29C66/3452—Making complete joints by combining partial joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43—Joining a relatively small portion of the surface of said articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43—Joining a relatively small portion of the surface of said articles
    • B29C66/431—Joining the articles to themselves
    • B29C66/4312—Joining the articles to themselves for making flat seams in tubular or hollow articles, e.g. transversal seams
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81433—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined being toothed, i.e. comprising several teeth or pins, or being patterned
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81433—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined being toothed, i.e. comprising several teeth or pins, or being patterned
    • B29C66/81435—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined being toothed, i.e. comprising several teeth or pins, or being patterned comprising several parallel ridges, e.g. for crimping
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53—Joining single elements to tubular articles, hollow articles or bars
    • B29C66/532—Joining single elements to the wall of tubular articles, hollow articles or bars
    • B29C66/5326—Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
    • B29C66/53261—Enclosing tubular articles between substantially flat elements
    • B29C66/53262—Enclosing spouts between the walls of bags, e.g. of medical bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
    • B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
    • B29C66/7234—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer
    • B29C66/72343—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer for liquids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
    • B29C66/832—Reciprocating joining or pressing tools
    • B29C66/8322—Joining or pressing tools reciprocating along one axis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/712—Containers; Packaging elements or accessories, Packages
    • B29L2031/7148—Blood bags, medical bags

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Package Specialized In Special Use (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Description

【０００１】
【発明の属する技術分野】
本発明は、複数の薬剤を別々に収容可能であって、使用時にはこれらを容易に混合可能な複室輸液容器とその製造方法に関する。
【０００２】
【従来の技術】
ビタミン剤などを生理食塩水に混合して、患者に注射あるいは点滴するなど、複数の薬剤を混合して患者に投与することが行われている。このように複数の薬剤を混合する場合、薬剤の種類によってはあらかじめ混合しておくと変質してしまうことがある。よって、このような変質の可能性のある複数の薬剤を別々に収容可能であって、使用する直前にこれらを混合可能な複室輸液容器が使用されている。このような複室輸液容器としては、その本体がポリオレフィンなどの熱可塑性樹脂フィルムから形成されているものがある。
【０００３】
このような熱可塑性樹脂フィルムからなる複室輸液容器においては、複数の薬剤を混合する前の段階では薬剤室と薬剤室との境界部分が液密にシールされているが、複数の薬剤を混合する際にはこの境界部分を容易に剥離し、開通可能であって、薬剤を迅速に混合できることが必要である。そのため、このような境界部分の形成方法については数多く研究されている。
【０００４】
例えば、特許文献１や特許文献２には、剥離しやすい境界部分を形成するために、接着に関与する部分を特定の材質から形成する技術が開示されている。また、特許文献３には、易剥離性コーティング剤を境界部分の内面に塗布し、剥離しやすくする方法が記載されている。
一方、特許文献４には、この境界部分をシールする際に使用するヒートシールバーとして、特定の形状のシールエッジが形成された２本のバーを組み合わせて使用し、これらシールエッジの位置を精密に制御したうえでフィルムを挟持することによって、境界部分の剥離強度を適度な範囲とする技術が開示されている。
【０００５】
【特許文献１】
特開平２−４６７１号公報
【特許文献２】
特開２０００−１４７４６号公報
【特許文献３】
特開平１１−１６９４３２号公報
【特許文献４】
特開平８−２４３１４号公報
【０００６】
【発明が解決しようとする課題】
しかしながら、特許文献１および特許文献２に開示されている技術では、剥離しやすい境界部分を形成するためにその部分を多層構成とせざるを得ず、単層フィルムには適用できないうえ、フィルム製造のコストが高くなるという問題があった。また、特許文献３に記載された技術では、特定のコーティング剤が必要であり、製造工程や製造コストが増加するという問題があった。
【０００７】
一方、特許文献４に開示されている方法では、フィルムを多層構造としたり、コーティング剤を使用したりすることは必須ではないが、この境界部分をシールするヒートシールバーのシールエッジを位置合わせする必要があり、これらの位置ずれが起こると、形成された境界部分は、複室輸液容器ごとに剥離強度のばらつきが大きくなることがあった。また、特にヒートシールバーの目のピッチが狭い場合には、このような位置合わせが特に難しいうえ、たとえ、ヒートシール温度を一定温度に維持した場合であっても、複室輸液容器ごとに剥離強度がばらつく場合があり、所望の剥離強度の複室輸液容器を安定に生産することが望まれていた。
【０００８】
本発明は上記事情に鑑みてなされたもので、フィルムの材質、構成などに関わらず、複数の薬剤室と薬剤室との境界部分の剥離強度が安定した複室輸液容器を提供することを課題とする。また、このような複室輸液容器を、容易に生産性よく製造可能な方法を提供することを課題とする。
【０００９】
【課題を解決するための手段】
本発明者らは、複数の薬剤室同士を隔てる弱シール部を、融着の程度の異なる３種類の融着部を有して形成し、これら融着部のうち最も融着強度の大きな強融着部の占有面積の合計を制御することによって、上記課題を解決可能であることを見出し、本発明に到達した。なお、ここで融着強度が大きいとは、融着してシールされている部分の、剥離に要する力が大きいことを意味している。
また、本発明において融着とは、加熱しながら押圧して密着させたものを意味し、熱可塑性樹脂フィルムが溶融して完全に一体化しその境界が不明である状態を指すだけでなく、液密性が保たれている限りにおいて、熱可塑性樹脂フィルム同士の境界が認められる状態をも含むものである。
本発明の複室輸液容器は、熱可塑性樹脂フィルムから形成され、薬剤を収容する複数の薬剤室を有する複室輸液容器であって、当該複室輸液容器の周縁の少なくとも一部は、強シール部により液密にシールされ、各薬剤室同士は、剥離可能な弱シール部で液密にシールされ、前記弱シール部は融着強度の異なる３種類の融着部を有して形成され、これら融着部のうち最も融着強度の大きな強融着部は、当該弱シール部の両面に形成された凹部の一部であり、当該弱シール部で分散して分布し、かつ、その占有面積の合計が当該弱シール部の面積の２５％未満であることを特徴とする。
【００１０】
本発明の複室輸液容器の製造方法は、薬剤を収容する複数の薬剤室を有し、各薬剤室同士が剥離可能な弱シール部で液密にシールされた複室輸液容器の製造方法であって、重ねられた２枚の熱可塑性樹脂フィルムを両面側から、シール面にシールエッジが形成されている２本のヒートシールバーで挟持し、融着強度の異なる３種類の融着部を有する弱シール部を形成する弱シール工程を有し、該弱シール工程は、前記融着部のうち最も融着強度が大きく、前記弱シール部内で分散して分布する強融着部の占有面積の合計が、当該弱シール部の面積の２５％未満となるようになされることを特徴とする。
【００１１】
【発明の実施の形態】
以下、本発明を詳細に説明する。
［第１実施形態例］
図１は、本発明の複室輸液容器１０の一例であって、熱可塑性樹脂フィルムから形成され、薬剤が充填される２つの薬剤室１１，１２を備えたものである。この例の複室輸液容器１０においては、一方の薬剤室１１には薬剤投入部１３が接続され、他方の薬剤室１２には、これに薬剤を投入するとともに、薬剤を患者に投与する際にここから薬剤を排出させるための薬剤出入部１４が接続されている。
【００１２】
この複室輸液容器１０において２つの薬剤室１１，１２は、液密な弱シール部１５で隔てられている。この弱シール部１５は、薬剤室１１，１２にそれぞれ薬剤が充填された後、少なくともいずれか一方の薬剤室１１，１２に対して外方から力を加えることによって剥離されるようにヒートシールされていて、所望の際に薬剤同士を迅速かつ容易に混合できるようになっている。
一方、この複室輸液容器１０の周縁は、薬剤室１１，１２に外方から力を加えた場合でも剥離しない強シール部１６により液密に閉じられていて、熱可塑性樹脂フィルムがヒートシールされ、強く融着して形成されている。なお、この例においては、強シール部１６は、複室輸液容器１０の周縁の全周にわたって形成されているが、例えば、筒状の熱可塑性樹脂フィルムを材料として使用した場合などには、フィルムの長さ方向の両端部（図中、上端部および下端部）だけが強シール部１６となっていてもよく、必ずしも周縁全周に強シール部１６が形成されていなくてもよい。
【００１３】
そして、この例の複室輸液容器１０の弱シール部１５は、詳しくは後述するが、重ねられた２枚の熱可塑性樹脂フィルムを、シール面に特定のシールエッジが形成された２本のヒートシールバーで、その両面側から挟持することにより形成されたものであって、図２の拡大平面図にその一部分を示すように、融着強度の異なる３つの融着部、すなわち強融着部１５ａと中融着部１５ｂと弱融着部１５ｃとを有して形成されている。
これらのうち融着強度の最も高い強融着部１５ａは略正方形に形成され、弱シール部１５において略均一に分散して分布している。また、弱シール部１５において融着強度の最も低い弱融着部１５ｃは、強融着部１５ａよりも大きな略正方形に形成され、弱シール部１５において略均一に分散して分布している。強融着部１５ａと弱融着部１５ｃの間の融着強度を有する中融着部１５ｂは、略長方形に形成され、同じく弱シール部１５において略均一に分散して分布している。また、強融着部１５ａ、中融着部１５ｂ、弱融着部１５ｃのうち、強融着部１５ａの厚みが最も薄く、弱融着部１５ｃの厚みが最も厚くなっている。
【００１４】
さらに、これら３つの融着部のうち最も融着強度の高い強融着部１５ａは、その占有面積の合計が、弱シール部１５全体の面積の２５％未満となるように形成されている。
そのため、弱シール部１５の剥離強度が適度に制御され、これを開通する際に要する力、すなわち開通強度も適度となり、通常時は薬剤室１１，１２間を液密に保持し、一方、薬剤室１１，１２に外方から力が加えられた場合には容易に剥離し、開通可能に形成されている。
【００１５】
ここで弱シール部１５における各強融着部１５ａの占有面積の合計が２５％以上となると、開通強度が大きすぎ、必要時に容易に弱シール部１５を剥離できない。また、０．０１％未満であると開通強度が小さく、衝撃などで剥離してしまう可能性が生じる。よって、好ましくは、各強融着部１５ａの占有面積の合計は０．０１〜２５％であり、さらに好ましくは０．０１〜１５％であり、より好ましくは０．０５〜１０％である。
【００１６】
また、この例の複室輸液容器１０において各強融着部１５ａは、近接する各強融着部１５ａ間の間隔の平均、すなわち平均間隔Ａと、近接する各強融着部１５ａ間の距離の平均、すなわち平均距離Ｂとが、下記式（１）を満たすように分布している。
Ｂ＜２Ａ・・・（１）
ここで、近接する強融着部１５ａ間の距離とは、図３中、符号Ｂ１で例示するように、近接する強融着部１５ａの重心間の距離であって、平均距離Ｂとは、これらを平均したものである。また、近接する強融着部１５ａ間の間隔とは、符号Ａ１で例示するように、近接する強融着部１５ａの重心間を結んだ線上において、一方の強融着部１５ａの末端と他方の強融着部１５ａの末端との距離であって、平均間隔Ａとは、これらを平均したものである。
【００１７】
このように式（１）を満たすように強融着部１５ａが分布していると、より確実かつ容易に、弱シール部１５の開通強度を制御することができる。さらに、平均距離Ｂが１ｍｍ以上、好ましくは１．５ｍｍ以上、より好ましくは２ｍｍ以上であると、一層確実かつ容易に弱シール部１５の開通強度を制御可能となる。また、好ましい平均距離Ｂの上限は１０ｍｍで、より好ましくは５ｍｍである。一方、Ｂ≧２Ａであると、開通強度が大きくなりすぎて、必要時に薬剤室１１，１２に力を加えても、容易に弱シール部１５を開通できない場合がある。
なお、この例においては、各強融着部１５は、一辺がほぼ０．２ｍｍの略正方形（面積０．０４ｍｍ２）の面で、平均間隔Ａは１．８ｍｍ、平均距離Ｂは２ｍｍであって、強融着部の占有面積の合計は１％である。また、各強融着部１５ａがこのように面である場合には、その各面積が１ｍｍ２以下であることが好ましく、０．５ｍｍ２以下がより好ましい。
【００１８】
このような複室輸液容器１０によれば、弱シール部１５における各強融着部１５ａの占有面積の合計が２５％未満とされているので、弱シール部１５の剥離強度が適度に制御され、その結果、開通強度も適度となる。よって、使用する熱可塑性樹脂フィルムが、たとえ結晶性を有するポリオレフィン樹脂などの単層フィルムであって、剥離強度の制御が比較的難しい場合でも、形成する弱シール部１５の剥離強度を制御でき、その結果、開通強度を容易かつ確実に適切な範囲とすることができる。なお、開通強度の測定方法は、後述の実施例において説明する。
【００１９】
すなわち、結晶性を有するポリオレフィン樹脂フィルムをヒートシールする場合、通常、この樹脂の融点付近の温度でシールするが、融点付近においては、結晶の融解が急激に進行するため、ヒートシール温度が若干変動しただけであっても、形成される弱シール部１５の剥離強度が変動してしまう場合がある。このように剥離強度が変動してしまうと、個々の複室輸液容器１０によって弱シール部１５の開通強度にばらつきが出て、安定な性能を有するものを生産できなくなる可能性が生じる。しかしながら、このように強融着部１５ａの面積を制御すれば、熱可塑性樹脂フィルムとして結晶性を有する単層フィルムを使用し、その融点付近の温度でシールし、かつ、ヒートシール温度が若干変動してしまった場合でも、弱シール部１５の剥離強度のばらつきを最小限に抑え、一定の開通強度の複室輸液容器１０を安定生産することができる。
【００２０】
この例の複室輸液容器１０に使用される熱可塑性樹脂フィルムとしては、安価であり、透明性、柔軟性に優れるためポリオレフィン樹脂が好ましく、例えば高密度ポリエチレン、中密度ポリエチレン、高圧法低密度ポリエチレン、低密度ポリエチレン、直鎖状低密度ポリエチレン、エチレン−酢酸ビニル共重合体等のポリエチレン系樹脂、エチレン−ブタジエンランダム共重合体等のオレフィン系エラストマー、ポリプロピレン、エチレン−プロピレンランダム共重合体、α−オレフィン−プロピレンランダム共重合体等のポリプロピレン系樹脂やこれらの混合物などを例示できる。また、このような複室輸液容器１０によれば、上述したように、弱シール部１５を形成するために特定の樹脂を選択して使用する必要は特にないので、熱可塑性樹脂フィルムとして医療の分野で用いられるものであれば特に限定されず使用可能であり、塩化ビニル、エチレン酢酸ビニル共重合体、ポリエーテルサルホン、環状ポリオレフィン、環状ポリオレフィン共重合体、水素化スチレンエチレンブタジエン共重合体などのスチレン系エラストマー、これらの樹脂の混合物、さらにはこれらと上記ポリオレフィン系樹脂との混合物などからなるフィルムも使用できる。また、これらの樹脂は耐熱性向上等の目的で一部架橋されていても構わない。
【００２１】
さらに、使用される熱可塑性樹脂フィルムは、一種類のフィルムからなる単層フィルムであっても、複数の種類のフィルムが積層した形態の多層フィルムであってもよい。単層フィルムの場合には、透明性、柔軟性に優れる事から直鎖状低密度ポリエチレン、エチレンプロピレンランダム共重合体、エチレンプロピレンブロック共重合体、ポリプロピレン系樹脂とスチレン系エラストマーとの混合物などのフィルムが好ましい。多層フィルムの場合には、複室輸液容器の外側から、高密度ポリエチレン／直鎖状低密度ポリエチレン、中密度ポリエチレン／低密度ポリエチレン／高密度ポリエチレン、高密度ポリエチレン／低密度ポリエチレン／高密度ポリエチレンなどのものを例示できる。
また、多層フィルムにおいて、内層がイージーピールを可能にする樹脂組成物から構成されていてもよい。
さらに、フィルムの製造方法については特に限定されず、Ｔダイ成形、水冷インフレーション成形、ブロー成形、ラミネーション成形などによる製造方法が挙げられる。透明性の観点からはＴダイ成形、水冷インフレーション成形が好ましい。
また、熱可塑性樹脂フィルムとしては、厚み５〜１０００μｍ、好ましくは５０〜５００μｍ程度のものが使用される。
【００２２】
このような複室輸液容器１０の弱シール部１５は、図４に示すようなシールエッジ２０ａ，２１ａがシール面に形成された２本のヒートシールバー２０，２１を使用して、重ねられた２枚の熱可塑性樹脂フィルムを両面側から挟持することにより形成できる。なお、ここで、重ねられた２枚の熱可塑性樹脂フィルムとしては、フィルム状のものを２枚重ねて使用しても良いし、あらかじめ筒状に形成されたフィルムを使用してもよい。また、２枚の熱可塑性樹脂フィルムに加えて弱シール部１５に新たなフィルムを挿入してシールしてもよい。
図４の２本のヒートシールバー２０，２１は、図５に拡大して示すように、シールエッジ２０ａ，２１ａとして、シール面に幅Ｗ０．２ｍｍの複数の凸条が互いに平行に２ｍｍの距離Ｐで形成されたものであって、この２本のヒートシールバー２０，２１を、一方のヒートシールバー２０の凸条のシールエッジ２０ａと他方のヒートシールバー２１の凸条のシールエッジ２１ａとが９０°に交差するように配置して、重ねられた２枚の熱可塑性樹脂フィルムを挟持する。
【００２３】
その結果、熱可塑性樹脂フィルムの両面側からそれぞれシールエッジ２０ａ，２１ａが接触し、圧接された部分は厚みが薄く、強く融着した強融着部１５ａとなり、両面側からヒートシールバー２０，２１のシールエッジ２０ａ，２１ａがいずれも接触しない部分は、熱伝導などで間接的に加熱され、弱く融着する弱融着部１５ｃとなる。また、いずれか一方のヒートシールバー２０，２１のシールエッジ２０ａ，２１ａのみが接触する部分は、強融着部１５ａと弱融着部１５ｃの間の融着強度を有する中融着部１５ｂとなる。
よって、あらかじめシールエッジの幅Ｗや距離Ｐ、場合によっては後述するエッジ角度などを適宜調整し、熱可塑性樹脂フィルムの両面側からそれぞれシールエッジ２０ａ，２１ａが接触して圧接される部分の面積の合計が、弱シール部１５全体の２５％未満となるようなヒートシールバー２０，２１を使用することにより、容易に、一定の開通強度を有する弱シール部１５を形成することができる。
【００２４】
また、このような方法によれば、ヒートシール温度が最適温度よりも１℃程度変動した場合でも、弱シール部１５の開通強度が１０００Ｎ以下、より好ましくは７５０Ｎ以下の範囲でしか変動しないものが得られる。すなわち、開通強度上昇率は、１０００Ｎ／℃以下、好ましくは７５０Ｎ／℃以下となる。開通強度は実用上３００〜２０００Ｎ程度が好ましく、３００〜１５００Ｎがより好ましいいが、このような方法によれば若干ヒートシール温度がずれても、開通強度がこの範囲内に容易に収まることとなる。なお、ヒートシール温度は、使用される熱可塑性樹脂フィルムに応じて適宜決定すればよい。また、好ましくは、略平行に形成された複数の凸条のシールエッジ２０ａ，２１ａの幅Ｗは１ｍｍ以下、より好ましくは０．５ｍｍ以下とし、距離Ｐは１ｍｍ以上とする。
【００２５】
また、このような方法によれば、形成される強融着部１５ａの占有面積の合計が弱シール部１５の面積の２５％未満となるように、シールエッジ２０ａ，２１ａの幅Ｗや距離Ｐ、場合によってはエッジ角度が調整されたヒートシールバー２０，２１を使用するだけで、所望の開通強度の弱シール部１５を形成できるので、弱シール部１５をこのように形成する弱シール工程とともに、複室輸液容器１０の周縁を液密にシールする強シール工程を同時に行うことも可能となる。
すなわち、強シール部１６が形成される複室輸液容器１０の周縁と、弱シール部１５が形成される複室輸液容器１０の中央部とを同時に挟持できるような型の図示略のヒートシールバーを使用し、弱シール部１５を形成する部分のシールエッジ２０ａ，２１ａは、上述したように、強融着部１５ａの占有面積の合計が２５％未満となるようなものとし、一方、強シール部１６を形成する部分のシールエッジは、薬剤室１１，１２に力が加えられた場合でも剥離しないようなものとすることによって、熱可塑性樹脂フィルムをヒートシールバーで挟持するという１回の操作のみで、同時に弱シール部１５と強シール部１６とを形成することができる。
【００２６】
なお、弱シール部１５を形成するヒートシールバーに形成されたシールエッジのエッジ角度αは、図５に示すように１２０度以下であることが好ましい。１２０度を超えると、強融着部１５の面積の制御が困難となる可能性がある。より好ましくは、９０度以下、さらに好ましくは６０度以下である。
【００２７】
こうして製造された複室輸液容器１０の弱シール部１５ａは、図６（ａ）（ｂ）に、図３のＩ−Ｉ’線およびＩＩ−ＩＩ’線に沿う断面図をそれぞれ概略的に示すように、ヒートシールバー２０，２１のシールエッジ２０ａ，２１ａが熱可塑性樹脂フィルムに接触することにより凹部が形成された状態となる。この例の場合には、弱シール部１５の両面に、接触したシールエッジの形状に沿って、幅が約０．２ｍｍか、それより若干広く、互いの距離が約２ｍｍの平行な凹条２２ａがそれぞれ形成される。そして、この凹条２２ａのうち、一部は熱可塑性樹脂フィルムの両面側からシールエッジ２０ａ，２１ａが圧接して形成された強融着部１５ａであり、残りの部分は、熱可塑性樹脂フィルムの一方の側からのみシールエッジ２０ａ，２１ａが接触した中融着部１５ｂとなっている。
こうして形成される凹条２２ａは、シールエッジ２０ａ，２１ａの幅Ｗや距離Ｐに対応して決定されるが、好ましくは、図示する幅Ｗ’は約１ｍｍ以下で距離Ｐ’は約１ｍｍ以上である。なお、幅Ｗ’は幅Ｗと同じか若干大きくなる傾向があり、距離Ｐ’は距離Ｐとほぼ同じである。
【００２８】
なお、この例で凹条２２ａは、複室輸液容器１０の長さ方向に対して、４５°の角度に形成されている。この角度には特に制限はないが、３０〜６０°の範囲であることが好ましい。図２中、矢印方向が複室輸液容器１０の長さ方向である。
【００２９】
また、この例では、強融着部１５ａは弱シール部１５においてほぼ均一に分散し、分布しているが、強融着部１５ａの占有面積の合計が、弱シール部１５の２５％未満とされている限りは、その分布状態が弱シール部１５の幅方向、すなわち、図１の左右方向にある程度異なっていてもよい。例えば、図示は略すが、幅方向の中央部付近には強融着部１５ａを密に分布させ、幅方向の両端部付近には粗に分布させたり、その反対に、幅方向の中央部付近には強融着部１５ａを粗に分布させ、幅方向の両端部付近には密に分布させたりしてもよい。
このように強融着部１５ａの分布状態を弱シール部１５ａの幅方向で異なるように形成することにより、この弱シール部１５ａを剥離、開通する際の状態を所望のようにしたり、複室輸液容器１０を誤って落下させ、弱シール部１５の幅方向の端部に力が加わっても開通しないようになど、種々調整することができる。このように強融着部１５ａの分布の状態を幅方向で異ならせるためには、ヒートシールバーとして、シール面のシールエッジが、この分布に沿って形成されたものを使用すればよい。
【００３０】
［参考例１］
図７は参考例１の複室輸液容器１０における弱シール部１５を示すものである。
この例の弱シール部１５も、重ねられた２枚の熱可塑性樹脂フィルムを、シール面に特定のシールエッジが形成された２本のヒートシールバーで、その両面側から挟持することにより形成されたものであって、融着強度の異なる２つの融着部、すなわち強融着部１５ａと弱融着部１５ｃとを有して形成されている。
これらのうち融着強度の高い強融着部１５ａは略正方形と線状とに形成され、線状の強融着部１５ａは互いに略平行に等間隔で配置され、これらの間に略正方形の強融着部１５ａが分散して分布している。融着強度の低い弱融着部１５ｃは、弱シール部１５における強融着部１５ａ以外の全部分である。
【００３１】
そして、この例においても、これら２つの融着部のうち剥離強度の高い強融着部１５ａは、その占有面積の合計が、弱シール部１５全体の面積の２５％未満となるように形成され、弱シール部１５の開通強度が適度に制御されている。
また、この例においても、弱シール部１５において分散して分布した各強融着部１５ａは、近接する強融着部１５ａ間の平均間隔Ａと、平均距離Ｂとが上記式（１）の関係を満たすように分布し、さらに、平均距離Ｂが好ましくは１ｍｍ以上、より好ましくは１．５ｍｍ以上、特に好ましくは２ｍｍ以上であると、非常に確実かつ容易に、弱シール部１５の開通強度を制御でき好ましい。
【００３２】
なお、この例の場合、近接する略正方形同士の間隔Ａ１および距離Ｂ１は、第１実施形態の場合と同様に図８のように求められる。一方、線状の強融着部１５ａとこれに近接する略正方形などの面状の強融着部１５ａとの距離Ｂ２は、面状の強融着部１５ａの重心から線状の強融着部１５ａに対して垂線をひき、その垂線上における線状の強融着部１５ａの幅方向の中心点と、前記重心との長さである。また、間隔Ａ２は、この垂線上において、一方の強融着部１５ａの末端と他方の強融着部１５ａの末端との距離である。そして、これらをそれぞれ平均することにより、平均間隔Ａと平均距離Ｂが同様に求められる。
また、このように強融着部１５ａが線状のものと面状のものとなる場合、面は面積１ｍｍ２以下であり、線は幅１ｍｍ以下であることが好ましい。また、面状である場合、その形状は略正方形に限定されず、他の多角形や円形などであってもよい。
【００３３】
このような複室輸液容器１０の弱シール部１５は、図９に示すようなシールエッジ２３ａ，２４ａがシール面に形成された２本のヒートシールバー２３，２４を使用して、重ねられた２枚の熱可塑性フィルムを両面側から挟持することにより形成できる。
図９の２本のヒートシールバー２３，２４のうち一方のヒートシールバー２３は、シールエッジ２３ａとして、第１実施形態例で使用したような、シール面に複数の凸条が互いに平行に形成されたものを備え、他方のヒートシールバー２４は、シール面に、等間隔に格子状に分布した多数の略正方形の凸面からなるシールエッジ２４ａを有している。そして、一方のヒートシールバー２３の凸条のシールエッジ２３ａと他方のヒートシールバー２４の凸面２４ａとが互いにずれるように熱可塑性樹脂フィルムを挟持する。
【００３４】
その結果、熱可塑性樹脂フィルムのいずれか一方の面側からシールエッジ２３ａ，２４ａが接触し、圧接された部分は強く融着した強融着部１５ａとなり、両面側からヒートシールバー２３，２４のシールエッジ２３ａ，２４ａがいずれも接触しない部分は、熱伝導などで間接的に加熱され、弱く融着する弱融着部１５ｃとなる。
ここで、あらかじめ各シールエッジ２３ａ，２４ａの幅や距離、場合によってはエッジ角度などを適宜調整し、熱可塑性樹脂フィルムのいずれか一方の面側からシールエッジ２３ａ，２４ａが接触して圧接される部分の面積の合計が、弱シール部１５全体の２５％未満となるようなヒートシールバー２３，２４を適宜使用することにより、容易に、一定の開通強度の弱シール部１５を安定に形成することができる。このようなヒートシールバー２３，２４を使用する場合、略平行に形成された複数の凸条のシールエッジ２３ａの幅は好ましくは１ｍｍ以下とし、距離は１ｍｍ以上とする。また、凸面からなるシールエッジ２４ａの面積は、１ｍｍ２以下とすることが好ましい。
【００３５】
こうして形成されたこの例の複室輸液容器１０の弱シール部１５ａは、図１０に、図８のＩＩＩ−ＩＩＩ’線に沿う断面図を示すように、ヒートシールバー２３，２４のシールエッジ２３ａ，２４ａが熱可塑性樹脂フィルムに接触することにより凹部が形成された状態となる。この例の場合には、弱シール部１５の両面に凹部を有し、具体的には一方の面には凹条２２ａが形成され、他方の面には略正方形の凹面２２ｂが形成されている。この凹条２２ａおよび凹面２２ｂが形成された部分が、いずれも強融着部１５ａである。
こうして形成される凹条２２ａは、使用されるヒートシールバーの有するシールエッジの幅や距離に対応したものとなり、幅はシールエッジの幅と同じか若干大きく、距離はシールエッジの距離とほぼ同じとなる。こうして形成される凹条２２ａは好ましくは、幅が１ｍｍ以下で互いの距離が１ｍｍ以上である。また、凹面２２ｂは、凸面からなるシールエッジの面積とほぼ同じであり、１ｍｍ２以下が好ましい。
【００３６】
なお、このように強融着部１５ａと弱融着部１５ｃからなる弱シール部１５の形成は、このような方法の他、使用する熱可塑性フィルムよりも耐熱性が優れ、形成される強融着部１５ａに対応した穴が形成されたフィルム製の型を使用する方法でも可能である。すなわち、このような型を介して熱可塑性樹脂フィルムを加熱することによって、穴に対応する部分は強く融着した強融着部１５ａとなり、それ以外の部分は弱融着部１５ｃとなる。
【００３７】
［参考例２］
図１１は参考例２の複室輸液容器１０における弱シール部１５を示すものである。
この例の弱シール部１５も、重ねられた２枚の熱可塑性樹脂フィルムを２本のヒートシールバーで、その両面側から挟持することにより形成されたものであって、強融着部１５ａと弱融着部１５ｃとを有して形成されている。
これらのうち融着強度の高い強融着部１５ａは略正方形に形成され、融着強度の低い弱融着部１５ｃは、弱シール部１５における強融着部１５ａ以外の全部分である。
そして、この例においても強融着部１５ａは、その占有面積の合計が、弱シール部１５全体の面積の２５％未満となるように形成され、その結果、弱シール部１５の開通強度が適度に制御されている。
【００３８】
このような複室輸液容器１０の弱シール部１５は、図９において符号２４で示した、等間隔に格子状に分布した多数の略正方形の凸面からなるシールエッジ２４ａを有するヒートシールバーと、シールエッジが形成されていない図示略の平面状のシール面を備えたヒートシールバーとで、重ねられた２枚の熱可塑性フィルムを両面側から挟持することにより形成でき、凸面からなるシールエッジ２４ａと、平面状のシール面とで挟まれ、圧接された部分が強く融着した強融着部１５ａとなる。一方の面側からヒートシールバーの平面状のシール面のみが接触した部分は、弱く融着する弱融着部１５ｃとなる。
この場合も、このようにして形成される強融着部１５ａの占有面積の合計が、弱シール部１５全体の２５％未満となるように、ヒートシールバーを選択して使用することにより、容易に、一定の剥離強度を有する安定した弱シール部１５を形成することができる。このようなヒートシールバーを使用する場合も、凸面からなるシールエッジ２４ａの面積は、１ｍｍ２以下とすることが好ましい。
【００３９】
こうして形成されたこの例の複室輸液容器１０の弱シール部１５は、図１２に、図１１のＩＶ−ＩＶ’線に沿う断面図を示すように、ヒートシールバーのシールエッジが熱可塑性樹脂フィルムに接触することにより、一方の面にのみ凹部、具体的には凹面２２ｂが形成された状態となる。この例の場合には、この部分がいずれも強融着部１５ａである。
こうして形成される凹面２２ｂは、面積が１ｍｍ２以下の凸面からなるシールエッジ２４ａを有するヒートシールバー２４から形成された場合、その面積もほぼ１ｍｍ２以下となる。
【００４０】
なお、この例の弱シール部１５を形成する場合には、まず、弱シール部１５を形成する部分の全体を、シールエッジが形成されていない図示略の平面状のシール面を備えたヒートシールバーでシールし、その後、符号２４で示す、等間隔に格子状に分布した多数の略正方形の凸面からなるシールエッジ２４ａを有するヒートシールバーでさらに加熱する方法でも、強融着部１５ａと弱融着部１５ｃとを形成できる
【００４１】
本発明の複室輸液容器１０においては、特に、弱シール部１５は融着強度の異なる３種類の融着部を有して形成され、これら融着部のうち最も融着強度の大きな強融着部１５ａは、弱シール部１５において分散して分布し、かつ、その占有面積の合計が弱シール部１５の面積の２５％未満に制御されているので、弱シール部１５の開通強度が適度に制御されていて、通常時は薬剤室１１，１２間を液密に保持し、一方、薬剤室１１，１２に外方から力が加えられた場合には容易に開通可能に形成されている。また、たとえ、熱可塑性樹脂フィルムとして結晶性を有する単層フィルムを使用し、その融点付近の温度でシールし、かつ、若干ヒートシール温度が若干変動してしまった場合でも、弱シール部１５の開通強度のばらつきを最小限に抑え、一定の性能の複室輸液容器１０を安定生産することができる。
【００４２】
【実施例】
以下本発明について、実施例を挙げて具体的に説明する。
［実施例１］
水冷インフレーション法で、直線状低密度ポリエチレン（ＭＦＲ：２ｇ／１０分（１９０℃）、密度０．９２５ｇ／ｃｍ３ ＪＩＳ Ｋ６７６０、）からなる厚さ３００μｍのフィルムを作成した。
このフィルムを２枚重ね、２本のヒートシールバーでこれを両面側から挟持することにより、剥離、開通可能な弱シール部１５と、剥離しない強シール部１６とを形成し、図１に示した複室輸液容器１０と同じ形態のものを製造した。なお、弱シール部１５は、複室輸液容器１０の長さ方向の中央部に１０ｍｍ長さで形成した。また、この際に使用した２本のヒートシールバーは、図４に示すように、凸条のシールエッジが多数略平行に形成されたものであって、シールエッジの幅Ｗが０．２ｍｍ、距離Ｐが２ｍｍ、エッジ角度αが９０°のものであり、弱シール部１５における強融着部１５ａの占有面積の合計はいずれも４％であった。また、シール条件は、シール圧力０．３９ＭＰａ、シール時間４秒とし、ヒートシール温度は１１８℃、１１９℃、１２０℃の３種類の温度で行った。すなわち、ヒートシール温度のみが異なる３つの複室輸液容器１０を製造した。
【００４３】
こうして形成された２つの複室輸液容器１０の薬剤室１１，１２に、それぞれ薬剤のかわりに着色された水を１０００ｍＬ充填した後、圧縮試験器（オリエンテック社製：ＲＴＣ１２５０Ａ）を使用し、１００ｍｍ×１００ｍｍの平板で一方の薬剤室１１，１２を速度５００ｍｍ／分で押圧した。そして、弱シール部１５が開通した際の荷重を測定し、これを弱シール部１５の開通強度とした。
その結果、このようにして得られた複室輸液容器１０における弱シール部１５の開通強度は、ヒートシール温度１１８℃のもので２５３Ｎ、１１９℃のもので７６０Ｎ、１２０℃のもので１２６７Ｎとなり、３００〜１０００Ｎにおける開通強度上昇率（１℃あたりの開通強度の変化）は５０７Ｎ／℃と小さく、ヒートシール温度が若干変動しても、開通強度は大きく変化しないことがわかった。
さらに、これらの複室輸液容器１０の両方の薬剤室１１，１２にそれぞれ１０００ｍＬの着色された水を入れた後、これを平坦な台の上に載置し、両方の薬剤室１１，１２を交互に合計５回、手で押圧したところ、弱シール部１５の全体が剥離した（５回以内で全体が剥離したものを表１において開通性：○で示す）。また、形成された複室輸液容器１０の弱シール部１５における凹条の幅Ｗ’と距離Ｐ’（図６参照）は、それぞれ、２ｍｍ、０．４ｍｍで、上記式（１）における平均間隔Ａおよび平均距離Ｂはそれぞれ１．６ｍｍ、２ｍｍであった。なおこれらの測定は、弱シール部１５を倍率２０倍で撮影した写真を用いて行った。
以上の結果などを表１および表２にまとめる。
【００４４】
［実施例２］
使用した２本のヒートシールバーのシールエッジの幅Ｗを０．２ｍｍ、距離Ｐを４ｍｍ、エッジ角度αを９０°とし、ヒートシール温度を１２０℃、１２１℃、１２２℃とした以外は、実施例１と同様にして３種の複室輸液容器１０を製造した。弱シール部１５における強融着部１５ａの占有面積の合計はいずれも０．６％であった。
これらについて、実施例１と同様に評価した結果などを表１および表２に示す。
表２に示すように、開通強度３００〜１０００Ｎにおける開通強度上昇率は小さく、ヒートシール温度が若干変動しても開通強度は大きく変化しないことがわかった。また、開通性も良好であった。
【００４５】
［比較例１］
使用した２本のヒートシールバーのシールエッジの幅Ｗを０．４ｍ、距離Ｐを１ｍｍ、エッジ角度αを９０°とし、ヒートシール温度を１１７℃と１１８℃とした以外は、実施例１と同様にして２種の複室輸液容器１０を製造した。弱シール部１５における強融着部１５ａの占有面積の合計はいずれも２５％であった。
これらについて、実施例１と同様に評価した結果などを表１および表２に示す。
表２に示すように、開通強度３００〜１０００Ｎにおける開通強度上昇率は大きく、ヒートシール温度が若干変動しても開通強度が大きく変化することがわかった。また、開通性については、弱シール部１５が一部剥離せず、良好ではなかった（表２中×で示す）。
【００４６】
［比較例２］
使用した２本のヒートシールバーのシールエッジの幅Ｗをいずれも０．２ｍ、距離Ｐを２ｍｍ、エッジ角度α１５０°とし、ヒートシール温度を１１７℃と１１８℃とした以外は、実施例１と同様にして２種の複室輸液容器１０を製造した。弱シール部１５における強融着部１５ａの占有面積の合計はいずれも３０％であった。
これらについて、実施例１と同様に評価した結果などを表１および表２に示す。
表２に示すように、開通強度３００〜１０００Ｎにおける開通強度上昇率は大きく、ヒートシール温度が若干変動しても開通強度が大きく変化することがわかった。また、開通性については、弱シール部１５が一部剥離せず、良好ではなかった。
【００４７】
［参考試験例１］
２本のヒートシールバーとして、図９に示すように、シールエッジが凸条のものと、シールエッヂが凸面（正方形のものが格子状に均一に存在）のものを組み合わせて使用した。なお、これらシールエッジは、いずれも幅Ｗ０．２ｍｍ、距離Ｐ４ｍｍ、エッジ角度α９０°とした。そして、ヒートシール温度を１１８℃、１１９℃、１２０℃とした以外は、実施例１と同様にして３種の複室輸液容器１０を製造した。弱シール部１５における強融着部１５ａの占有面積の合計はいずれも８％であった。
これらについて、実施例１と同様に評価した結果などを表１および表２に示す。
表２に示すように、開通強度３００〜１０００Ｎにおける開通強度上昇率は小さく、ヒートシール温度が若干変動しても開通強度は大きく変化しないことがわかった。また、開通性も良好であった。
なお表１中、平均距離Ａ１および平均距離Ｂ１は、図８に示すように、凹面である強融着部１５ａ間について測定し、平均距離Ａ２および平均距離Ｂ２は、凹面と凹条の強融着部１５ａ間について測定したものである。
【００４８】
［参考試験例２］
２本のヒートシールバーとして、一方をシールエッジが凸面（正方形）である図９において符号２４で示す形態のものとし、他方をシールエッジのない平面状のシール面を備えたものとし、これらを組み合わせて使用した。なお、凸面であるシールエッジは、幅Ｗ０．２ｍｍ、距離Ｐ２ｍｍ、エッジ角度６０°とした。
そして、ヒートシール温度を１２０℃、１２１℃、１２２℃とした以外は、実施例１と同様にして３種の複室輸液容器１０を製造した。弱シール部１５における強融着部１５ａの占有面積の合計はいずれも１％であった。
これらについて、実施例１と同様に評価した結果などを表１および表２に示す。
表２に示すように、開通強度３００〜１０００Ｎにおける開通強度上昇率は小さく、ヒートシール温度が若干変動しても開通強度は大きく変化しないことがわかった。また、開通性も良好であった。
【００４９】
［比較例３］
２本のヒートシールバーとして、いずれもシールエッジのない平面状のシール面を備えたものを組み合わせて使用した。そして、ヒートシール温度を１１７℃と１１８℃の２種とした以外は、実施例１と同様にして２種の複室輸液容器１０を製造した。弱シール部１５における強融着部１５ａの占有面積の合計はいずれも１００％であった。
表２に示すように、開通強度３００〜１０００Ｎにおける開通強度上昇率は大きく、ヒートシール温度が若干変動しても開通強度が大きく変化することがわかった。また、開通性については、弱シール部１５が一部剥離せず、良好ではなかった。
【００５０】
【表１】

Figure 0004298308
【００５１】
【表２】
Figure 0004298308
【００５２】
また、各例で得られた全ての複室輸液容器１０は、いずれも薬剤室１１，１２に液を充填した後、目視では弱シール部１５への液の漏れは認められなかった。
【００５３】
【発明の効果】
以上説明したように、本発明の複室輸液容器は、弱シール部における強融着部の占有面積の合計が２５％未満とされているので、フィルムの材質、構成などに関わらず、複数の薬剤室と薬剤室との境界部分の剥離強度が安定した複室輸液容器となる。また、本発明の製造方法によれば、このような複室輸液容器を、容易に生産性よく製造することができる。
【図面の簡単な説明】
【図１】 本発明の複室輸液容器の一例を示す平面図である。
【図２】 図１の複室輸液容器の弱シール部を部分的に拡大した平面図である。
【図３】 図１の複室輸液容器の弱シール部をさらに部分的に拡大した平面図である。
【図４】 図１の複室輸液容器の弱シール部を形成するために使用したヒートシールバーの斜視図である。
【図５】 図４におけるＶ−Ｖ’に沿う断面図である。
【図６】 図３における（ａ）Ｉ−Ｉ’に沿う断面図と、（ｂ）ＩＩ−ＩＩ’線に沿う断面図である。
【図７】 参考例１の複室輸液容器における弱シール部を部分的に拡大した平面図である。
【図８】 図７と同様の平面図である。
【図９】 図７の複室輸液容器の弱シール部を形成するために使用したヒートシールバーの斜視図である。
【図１０】 図８におけるＩＩＩ−ＩＩＩ’線に沿う断面図である。
【図１１】 参考例２の複室輸液容器における弱シール部を部分的に拡大した平面図である。
【図１２】 図１１におけるＩＶ−ＩＶ’線に沿う断面図である。
【符号の説明】
１０ 複室輸液容器
１１，１２ 薬剤室
１５ 弱シール部
１５ａ 強融着部
１６ 強シール部
２０，２１ ヒートシールバー
２２ａ 凹条
２２ｂ 凹面
２３，２４ ヒートシールバー[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a multi-chamber infusion container that can accommodate a plurality of drugs separately and can be easily mixed during use, and a method for producing the same.
[0002]
[Prior art]
It has been practiced that a plurality of drugs are mixed and administered to a patient, such as a vitamin preparation mixed with physiological saline and injected or instilled into the patient. When a plurality of drugs are mixed in this way, depending on the type of the drug, the quality may be deteriorated if they are mixed in advance. Therefore, a multi-chamber infusion container that can accommodate a plurality of drugs with such alterations separately and can mix them immediately before use is used. As such a multi-chamber infusion container, there is one in which the main body is formed of a thermoplastic resin film such as polyolefin.
[0003]
In a multi-chamber infusion container made of such a thermoplastic resin film, the boundary between the drug chamber and the drug chamber is liquid-tightly sealed before mixing a plurality of drugs. In this case, it is necessary that the boundary portion can be easily peeled off and opened so that the medicine can be mixed rapidly. For this reason, many researches have been made on methods for forming such boundary portions.
[0004]
For example, Patent Document 1 and Patent Document 2 disclose a technique for forming a part involved in adhesion from a specific material in order to form a boundary part that is easily peeled off. Further, Patent Document 3 describes a method in which an easily peelable coating agent is applied to the inner surface of the boundary portion to facilitate peeling.
On the other hand, Patent Document 4 uses a combination of two bars formed with a seal edge of a specific shape as a heat seal bar used when sealing this boundary portion, and precisely positions the seal edges. A technique is disclosed in which the peel strength at the boundary portion is controlled to an appropriate range by sandwiching the film after controlling the film thickness.
[0005]
[Patent Document 1]
JP-A-2-4671
[Patent Document 2]
JP 2000-14746 A
[Patent Document 3]
JP-A-11-169432
[Patent Document 4]
JP-A-8-24314
[0006]
[Problems to be solved by the invention]
However, in the techniques disclosed in Patent Document 1 and Patent Document 2, in order to form a boundary part that is easy to peel off, the part has to have a multilayer structure, and cannot be applied to a single-layer film. There was a problem of high costs. Moreover, in the technique described in Patent Document 3, a specific coating agent is required, and there is a problem that a manufacturing process and a manufacturing cost increase.
[0007]
On the other hand, in the method disclosed in Patent Document 4, it is not essential that the film has a multilayer structure or a coating agent is used, but the seal edge of the heat seal bar that seals this boundary portion is aligned. When these positional shifts occur, the formed boundary portion may have a large variation in peel strength for each multi-chamber infusion container. In addition, especially when the pitch of the heat seal bar is narrow, such alignment is particularly difficult, and even if the heat seal temperature is maintained at a constant temperature, peeling is performed for each multi-chamber infusion container. The strength may vary, and it has been desired to stably produce a multi-chamber infusion container having a desired peel strength.
[0008]
The present invention has been made in view of the above circumstances, and it is an object of the present invention to provide a multi-chamber infusion container in which the peel strength at the boundary portion between a plurality of drug chambers and drug chambers is stable regardless of the material and configuration of the film. And It is another object of the present invention to provide a method capable of easily manufacturing such a multi-chamber infusion container with high productivity.
[0009]
[Means for Solving the Problems]
  The inventors of the present invention have formed a weak seal portion that separates a plurality of drug chambers from three types of fusion portions having different degrees of fusion, and among these fusion portions, the strongest strength is the highest. The inventors have found that the above-described problems can be solved by controlling the total area occupied by the fused portions, and have reached the present invention. Here, the fact that the fusion strength is high means that the force required for peeling of the portion that has been fused and sealed is great.
  Further, in the present invention, fusion means not only the state in which the thermoplastic resin film is melted and completely integrated and the boundary thereof is unknown, but is not limited to liquid. As long as the denseness is maintained, it includes a state where the boundary between the thermoplastic resin films is recognized.
  The multi-chamber infusion container of the present invention is a multi-chamber infusion container formed of a thermoplastic resin film and having a plurality of drug chambers for containing drugs, and at least a part of the periphery of the multi-chamber infusion container is a strong seal Each of the drug chambers is liquid-tightly sealed with a peelable weak seal portion, and the weak seal portion is formed having three types of fusion portions having different fusion strengths, Among these fusion parts, the strong fusion part with the largest fusion strength isIt is a part of a recess formed on both surfaces of the weak seal part,The weak seal portion is distributed and distributed, and the total occupied area is less than 25% of the area of the weak seal portion.
[0010]
  The method for producing a multi-chamber infusion container according to the present invention is a method for producing a multi-chamber infusion container having a plurality of drug chambers for storing medicines and liquid-tightly sealed by weak seal portions that can be separated from each other. There are two stacked thermoplastic resin films from both sides.The seal edge is formed on the seal surfaceIt has a weak sealing step that is sandwiched between two heat seal bars and forms a weak seal portion having three types of fusion portions with different fusion strengths. The adhesion strength is high, and the total occupied area of the strongly fused portions distributed and distributed in the weak seal portion is less than 25% of the area of the weak seal portion.
[0011]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the present invention will be described in detail.
[First Embodiment]
FIG. 1 shows an example of a multi-chamber infusion container 10 according to the present invention, which includes two drug chambers 11 and 12 formed from a thermoplastic resin film and filled with drugs. In the multi-chamber infusion container 10 of this example, a drug input unit 13 is connected to one drug chamber 11, and a drug is input to the other drug chamber 12 and a drug is administered to a patient. A medicine loading / unloading section 14 for discharging the medicine from here is connected.
[0012]
In this multi-chamber infusion container 10, the two drug chambers 11 and 12 are separated by a liquid-tight weak seal portion 15. The weak seal portion 15 is heat-sealed so as to be peeled off by applying force from the outside to at least one of the drug chambers 11 and 12 after the drug chambers 11 and 12 are filled with the drug. Thus, the drugs can be mixed quickly and easily when desired.
On the other hand, the peripheral edge of the multi-chamber infusion container 10 is liquid-tightly closed by a strong seal portion 16 that does not peel even when force is applied to the drug chambers 11 and 12 from the outside, and the thermoplastic resin film is heat-sealed. It is formed with strong fusion. In this example, the strong seal portion 16 is formed over the entire circumference of the peripheral edge of the multi-chamber infusion container 10, but for example, when a cylindrical thermoplastic resin film is used as a material, the film Only the both end portions in the length direction (the upper end portion and the lower end portion in the figure) may be the strong seal portion 16, and the strong seal portion 16 does not necessarily have to be formed on the entire circumference.
[0013]
The weak seal portion 15 of the multi-chamber infusion container 10 of this example will be described in detail later, but the two thermoplastic resin films that are overlaid are formed of two heats with a specific seal edge formed on the seal surface. It is formed by sandwiching from both sides with a seal bar, and as shown in part in the enlarged plan view of FIG. 2, three fusion parts with different fusion strengths, that is, strong fusion parts 15a, a middle fusion part 15b, and a weak fusion part 15c.
Among these, the strong fusion portion 15a having the highest fusion strength is formed in a substantially square shape and is distributed substantially uniformly in the weak seal portion 15. Further, the weak fusion part 15 c having the lowest fusion strength in the weak seal part 15 is formed in a substantially square shape larger than the strong fusion part 15 a, and is distributed substantially uniformly in the weak seal part 15. The middle fusion portion 15b having a fusion strength between the strong fusion portion 15a and the weak fusion portion 15c is formed in a substantially rectangular shape, and is also distributed substantially uniformly in the weak seal portion 15. Of the strong fusion part 15a, the middle fusion part 15b, and the weak fusion part 15c, the strong fusion part 15a has the smallest thickness and the weak fusion part 15c has the largest thickness.
[0014]
Furthermore, the strong fusion part 15a having the highest fusion strength among these three fusion parts is formed such that the total occupied area is less than 25% of the entire area of the weak seal part 15.
Therefore, the peel strength of the weak seal portion 15 is appropriately controlled, and the force required for opening the weak seal portion 15, that is, the opening strength is also appropriate. When a force is applied to the chambers 11 and 12 from the outside, the chambers 11 and 12 are easily peeled and can be opened.
[0015]
Here, if the total occupied area of the strong fusion portions 15a in the weak seal portion 15 is 25% or more, the opening strength is too large and the weak seal portion 15 cannot be easily peeled off when necessary. Further, if it is less than 0.01%, the opening strength is small, and there is a possibility that the film will be peeled off by impact or the like. Therefore, Preferably, the total occupied area of each strong melt | fusion part 15a is 0.01-25%, More preferably, it is 0.01-15%, More preferably, it is 0.05-10%.
[0016]
Moreover, in the multi-chamber infusion container 10 of this example, each strong fusion part 15a is the average of the space | interval between each adjacent strong fusion part 15a, ie, the average space | interval A, and the distance between each adjacent strong fusion part 15a. , That is, the average distance B is distributed so as to satisfy the following formula (1).
B <2A (1)
Here, the distance between the adjacent strongly fused portions 15a is represented by the symbol B in FIG.1The distance between the centers of gravity of the close fusion-bonding portions 15a adjacent to each other, and the average distance B is an average of these. In addition, the interval between the adjacent strongly fused portions 15a is a symbol A.1The distance between the end of one strong fusion portion 15a and the end of the other strong fusion portion 15a on the line connecting the centroids of the adjacent strong fusion portions 15a, as shown in FIG. A is an average of these values.
[0017]
Thus, if the strong fusion | fusion part 15a is distributed so that Formula (1) may be satisfy | filled, the opening strength of the weak seal part 15 can be controlled more reliably and easily. Furthermore, when the average distance B is 1 mm or more, preferably 1.5 mm or more, more preferably 2 mm or more, the opening strength of the weak seal portion 15 can be controlled more reliably and easily. Moreover, the upper limit of the preferable average distance B is 10 mm, More preferably, it is 5 mm. On the other hand, if B ≧ 2A, the opening strength becomes too large, and the weak seal portion 15 may not be easily opened even if force is applied to the drug chambers 11 and 12 when necessary.
In this example, each strongly fused portion 15 has a substantially square shape with a side of approximately 0.2 mm (area 0.04 mm).2), The average distance A is 1.8 mm, the average distance B is 2 mm, and the total occupied area of the strongly fused portions is 1%. In addition, when each strongly fused portion 15a is a surface in this way, each area is 1 mm.2Or less, preferably 0.5 mm2The following is more preferable.
[0018]
According to such a multi-chamber infusion container 10, the total occupied area of each strongly fused portion 15 a in the weak seal portion 15 is less than 25%, so that the peel strength of the weak seal portion 15 is appropriately controlled. As a result, the opening strength is also moderate. Therefore, even if the thermoplastic resin film to be used is a single layer film such as a polyolefin resin having crystallinity and the control of the peel strength is relatively difficult, the peel strength of the weak seal portion 15 to be formed can be controlled, As a result, the opening strength can be easily and reliably set to an appropriate range. In addition, the measuring method of opening strength is demonstrated in the below-mentioned Example.
[0019]
That is, when heat-sealing a crystalline polyolefin resin film, it is usually sealed at a temperature near the melting point of this resin, but since the melting of the crystal proceeds rapidly in the vicinity of the melting point, the heat sealing temperature varies slightly. Even if it is only done, the peeling strength of the weak seal part 15 to be formed may vary. If the peel strength fluctuates in this way, there is a possibility that the opening strength of the weak seal portion 15 varies depending on the individual multi-chamber infusion container 10 and it becomes impossible to produce a product having stable performance. However, if the area of the strongly fused portion 15a is controlled in this way, a single layer film having crystallinity is used as the thermoplastic resin film, sealing is performed at a temperature near its melting point, and the heat sealing temperature is slightly changed. Even in such a case, the variation in the peel strength of the weak seal portion 15 can be minimized, and the multi-chamber infusion container 10 having a constant opening strength can be stably produced.
[0020]
The thermoplastic resin film used in the multi-chamber infusion container 10 of this example is preferably a polyolefin resin because it is inexpensive and excellent in transparency and flexibility. For example, high density polyethylene, medium density polyethylene, high pressure method low density polyethylene , Low density polyethylene, linear low density polyethylene, polyethylene resin such as ethylene-vinyl acetate copolymer, olefin elastomer such as ethylene-butadiene random copolymer, polypropylene, ethylene-propylene random copolymer, α- Examples thereof include polypropylene resins such as olefin-propylene random copolymers and mixtures thereof. Further, according to such a multi-chamber infusion container 10, as described above, it is not particularly necessary to select and use a specific resin for forming the weak seal portion 15. It can be used without particular limitation as long as it is used in the field, such as vinyl chloride, ethylene vinyl acetate copolymer, polyethersulfone, cyclic polyolefin, cyclic polyolefin copolymer, hydrogenated styrene ethylene butadiene copolymer, etc. A film comprising a styrene elastomer, a mixture of these resins, and a mixture of these with the above polyolefin resin can also be used. These resins may be partially crosslinked for the purpose of improving heat resistance.
[0021]
Furthermore, the thermoplastic resin film used may be a single-layer film made of one type of film or a multilayer film in which a plurality of types of films are laminated. In the case of a single layer film, since it is excellent in transparency and flexibility, linear low density polyethylene, ethylene propylene random copolymer, ethylene propylene block copolymer, a mixture of polypropylene resin and styrene elastomer, etc. A film is preferred. In the case of multilayer film, from the outside of the multi-chamber infusion container, high density polyethylene / linear low density polyethylene, medium density polyethylene / low density polyethylene / high density polyethylene, high density polyethylene / low density polyethylene / high density polyethylene, etc. Can be illustrated.
Moreover, in a multilayer film, the inner layer may be comprised from the resin composition which enables an easy peel.
Furthermore, it does not specifically limit about the manufacturing method of a film, The manufacturing method by T-die shaping | molding, water cooling inflation shaping | molding, blow molding, lamination shaping | molding etc. is mentioned. From the viewpoint of transparency, T-die molding and water-cooled inflation molding are preferable.
Moreover, as a thermoplastic resin film, the thickness of 5-1000 micrometers, Preferably about 50-500 micrometers is used.
[0022]
Such a weak seal portion 15 of the multi-chamber infusion container 10 was overlapped using two heat seal bars 20, 21 having seal edges 20a, 21a formed on the seal surface as shown in FIG. It can be formed by sandwiching two thermoplastic resin films from both sides. Here, as the two laminated thermoplastic resin films, two film-like ones may be used in a stacked manner, or a film formed in a cylindrical shape in advance may be used. Further, in addition to the two thermoplastic resin films, a new film may be inserted into the weak seal portion 15 and sealed.
As shown in the enlarged view of FIG. 5, the two heat seal bars 20 and 21 in FIG. 4 have, as seal edges 20a and 21a, a plurality of ridges having a width W of 0.2 mm on the seal surface and a distance of 2 mm parallel to each other. The two heat seal bars 20 and 21 are formed of P, and the protruding seal edge 20a of one heat seal bar 20 and the protruding seal edge 21a of the other heat seal bar 21 Are arranged so as to intersect at 90 °, and the two thermoplastic resin films stacked are sandwiched.
[0023]
As a result, the seal edges 20a and 21a come into contact with both sides of the thermoplastic resin film, respectively, and the pressed portions are thin and strongly fused, resulting in a strongly fused portion 15a, and the heat seal bars 20 and 21 from both sides. The portion where neither of the seal edges 20a, 21a comes into contact is indirectly heated by heat conduction or the like, and becomes a weakly fused portion 15c that is weakly fused. Moreover, the part where only the seal edges 20a and 21a of either one of the heat seal bars 20 and 21 are in contact with the intermediate fusion part 15b having a fusion strength between the strong fusion part 15a and the weak fusion part 15c. Become.
Therefore, the width W and distance P of the seal edge are adjusted as appropriate in advance, and the edge angle, which will be described later, is appropriately adjusted, and the area of the area where the seal edges 20a and 21a come into contact with each other from both sides of the thermoplastic resin film, respectively. By using the heat seal bars 20 and 21 such that the total is less than 25% of the entire weak seal portion 15, the weak seal portion 15 having a certain opening strength can be easily formed.
[0024]
Further, according to such a method, even when the heat seal temperature fluctuates by about 1 ° C. from the optimum temperature, the opening strength of the weak seal portion 15 varies only within the range of 1000 N or less, more preferably 750 N or less. can get. That is, the opening strength increase rate is 1000 N / ° C. or less, preferably 750 N / ° C. or less. In practice, the opening strength is preferably about 300 to 2000 N, and more preferably 300 to 1500 N. However, according to such a method, even if the heat seal temperature slightly shifts, the opening strength easily falls within this range. Become. In addition, what is necessary is just to determine a heat seal temperature suitably according to the thermoplastic resin film used. Preferably, the width W of the plurality of protruding seal edges 20a, 21a formed substantially in parallel is 1 mm or less, more preferably 0.5 mm or less, and the distance P is 1 mm or more.
[0025]
In addition, according to such a method, the width W and the distance P of the seal edges 20a and 21a are set so that the total occupied area of the formed strong fusion portion 15a is less than 25% of the area of the weak seal portion 15. In some cases, the weak seal portion 15 having a desired opening strength can be formed simply by using the heat seal bars 20 and 21 with the edge angle adjusted, so that the weak seal portion 15 is formed in this way. It is also possible to simultaneously perform a strong sealing step for sealing the periphery of the multi-chamber infusion container 10 in a liquid-tight manner.
That is, a heat seal bar (not shown) of a type that can simultaneously hold the peripheral edge of the multi-chamber infusion container 10 in which the strong seal portion 16 is formed and the central portion of the multi-chamber infusion container 10 in which the weak seal portion 15 is formed. As described above, the seal edges 20a and 21a of the portion forming the weak seal portion 15 are such that the total occupied area of the strong fusion portion 15a is less than 25%. One operation of sandwiching the thermoplastic resin film with a heat seal bar by making the seal edge of the portion forming the portion 16 not peel even when force is applied to the drug chambers 11 and 12. Only the weak seal portion 15 and the strong seal portion 16 can be formed simultaneously.
[0026]
The edge angle α of the seal edge formed on the heat seal bar forming the weak seal portion 15 is preferably 120 degrees or less as shown in FIG. If it exceeds 120 degrees, it may be difficult to control the area of the strongly fused portion 15. More preferably, it is 90 degrees or less, more preferably 60 degrees or less.
[0027]
The weak seal portion 15a of the multi-chamber infusion container 10 manufactured in this manner is schematically shown in FIGS. 6 (a) and 6 (b) as cross-sectional views taken along lines II ′ and II-II ′ of FIG. As described above, the seal edges 20a and 21a of the heat seal bars 20 and 21 come into contact with the thermoplastic resin film to form a recess. In the case of this example, along the shape of the seal edge in contact with both surfaces of the weak seal portion 15, the parallel recesses 22 a having a width of about 0.2 mm or slightly wider and a distance of about 2 mm from each other. Are formed respectively. A part of the recess 22a is a strong fusion part 15a formed by pressure-contacting the seal edges 20a and 21a from both sides of the thermoplastic resin film, and the remaining part is made of the thermoplastic resin film. The middle fused portion 15b is in contact with the seal edges 20a and 21a only from one side.
The groove 22a thus formed is determined in accordance with the width W and the distance P of the seal edges 20a and 21a. Preferably, the illustrated width W ′ is about 1 mm or less and the distance P ′ is about 1 mm or more. is there. The width W ′ tends to be the same as or slightly larger than the width W, and the distance P ′ is almost the same as the distance P.
[0028]
In this example, the recess 22a is formed at an angle of 45 ° with respect to the length direction of the multi-chamber infusion container 10. Although there is no restriction | limiting in particular in this angle, It is preferable that it is the range of 30-60 degrees. In FIG. 2, the arrow direction is the length direction of the multi-chamber infusion container 10.
[0029]
Further, in this example, the strong fusion portion 15a is distributed and distributed almost uniformly in the weak seal portion 15, but the total occupied area of the strong fusion portion 15a is less than 25% of the weak seal portion 15. As long as the distribution is performed, the distribution state may be somewhat different in the width direction of the weak seal portion 15, that is, in the left-right direction in FIG. For example, although not shown in the figure, the strongly fused portions 15a are densely distributed near the center in the width direction, and are roughly distributed near both ends in the width direction, and conversely, near the center in the width direction. Alternatively, the strongly fused portions 15a may be distributed roughly and densely distributed in the vicinity of both ends in the width direction.
Thus, by forming the distribution state of the strongly fused portion 15a so as to be different in the width direction of the weak seal portion 15a, the weak seal portion 15a can be made to have a desired state when the weak seal portion 15a is peeled off or opened. Various adjustments can be made such that the infusion container 10 is accidentally dropped and does not open even if a force is applied to the end of the weak seal 15 in the width direction. In this way, in order to vary the distribution state of the strongly fused portion 15a in the width direction, a heat seal bar having a seal edge on the sealing surface formed along this distribution may be used.
[0030]
[Reference example 1]
  FIG.Reference Example 1The weak seal part 15 in the multi-chamber infusion container 10 is shown.
  The weak seal portion 15 in this example is also formed by sandwiching two stacked thermoplastic resin films from two sides of the heat seal bar with a specific seal edge formed on the seal surface. In other words, it has two fusion parts having different fusion strengths, that is, a strong fusion part 15a and a weak fusion part 15c.
  Among these, the strong fusion portion 15a having a high fusion strength is formed in a substantially square shape and a linear shape, and the linear strong fusion portions 15a are arranged substantially in parallel with each other at equal intervals, and between them, a substantially square shape is formed. The strongly fused portions 15a are distributed and distributed. The weak fusion part 15c with low fusion strength is the entire part of the weak seal part 15 other than the strong fusion part 15a.
[0031]
Also in this example, the strong fusion part 15a having a high peel strength among these two fusion parts is formed such that the total occupied area is less than 25% of the entire area of the weak seal part 15. In addition, the opening strength of the weak seal portion 15 is appropriately controlled.
Also in this example, each of the strong fusion portions 15a distributed and distributed in the weak seal portion 15 has an average interval A and an average distance B between the adjacent strong fusion portions 15a of the above formula (1). When the average distance B is preferably 1 mm or more, more preferably 1.5 mm or more, and particularly preferably 2 mm or more, the opening strength of the weak seal portion 15 is very surely and easily distributed. Can be controlled.
[0032]
In this example, the distance A between adjacent squares1And distance B1Is obtained as shown in FIG. 8 as in the case of the first embodiment. On the other hand, the distance B between the linear strong fusion part 15a and the planar strong fusion part 15a such as a substantially square adjacent thereto.2Draws a perpendicular line from the center of gravity of the planar strong fusion portion 15a to the linear strong fusion portion 15a, the center point in the width direction of the linear strong fusion portion 15a on the perpendicular line, and the gravity center And the length. Also, the interval A2Is the distance between the end of one strongly fused portion 15a and the end of the other strongly fused portion 15a on the perpendicular. And the average space | interval A and the average distance B are calculated | required similarly by averaging these, respectively.
Further, in the case where the strongly fused portion 15a is linear and planar, the surface has an area of 1 mm.2The line is preferably 1 mm or less in width. Moreover, when it is planar, the shape is not limited to a substantially square, and may be another polygon or a circle.
[0033]
Such a weak seal portion 15 of the multi-chamber infusion container 10 is overlapped using two heat seal bars 23, 24 having seal edges 23a, 24a formed on the seal surface as shown in FIG. It can be formed by sandwiching two thermoplastic films from both sides.
One heat seal bar 23 of the two heat seal bars 23, 24 in FIG. 9 has a plurality of ridges formed parallel to each other on the seal surface as the seal edge 23a, as used in the first embodiment. The other heat seal bar 24 has seal edges 24a made up of a number of substantially square convex surfaces distributed in a lattice pattern at equal intervals on the seal surface. Then, the thermoplastic resin film is sandwiched so that the convex seal edge 23a of one heat seal bar 23 and the convex surface 24a of the other heat seal bar 24 are displaced from each other.
[0034]
As a result, the seal edges 23a and 24a come into contact with either side of the thermoplastic resin film, and the press-contacted portions become strongly fused portions 15a that are strongly fused, and the heat seal bars 23 and 24 are seen from both sides. The portion where neither of the seal edges 23a, 24a is in contact is indirectly heated by heat conduction or the like, and becomes a weakly fused portion 15c that is weakly fused.
Here, the width and distance of each seal edge 23a, 24a, the edge angle, etc. are appropriately adjusted in advance, and the seal edge 23a, 24a is brought into contact with and pressed from either side of the thermoplastic resin film. By appropriately using the heat seal bars 23 and 24 such that the total area of the portions is less than 25% of the entire weak seal portion 15, the weak seal portion 15 having a constant opening strength can be easily formed stably. be able to. When such heat seal bars 23 and 24 are used, the width of the plurality of protruding seal edges 23a formed substantially in parallel is preferably 1 mm or less, and the distance is 1 mm or more. Moreover, the area of the sealing edge 24a which consists of convex surfaces is 1 mm.2The following is preferable.
[0035]
The weak seal portion 15a of the multi-chamber infusion container 10 of this example formed in this way is, as shown in FIG. 10, a cross-sectional view taken along the line III-III ′ of FIG. 8, the seal edge 23a of the heat seal bars 23, 24. , 24a comes into contact with the thermoplastic resin film to form a recess. In the case of this example, the weak seal portion 15 has recesses on both surfaces, specifically, a recess 22a is formed on one surface, and a substantially square recess 22b is formed on the other surface. . The portions where the concave stripes 22a and the concave surfaces 22b are formed are both strongly fused portions 15a.
The recess 22a thus formed corresponds to the width and distance of the seal edge of the heat seal bar used, the width is the same as or slightly larger than the width of the seal edge, and the distance is almost the same as the distance of the seal edge. It becomes. The recesses 22a thus formed preferably have a width of 1 mm or less and a mutual distance of 1 mm or more. Further, the concave surface 22b is substantially the same as the area of the seal edge made of a convex surface, and is 1 mm.2The following is preferred.
[0036]
In addition, the formation of the weak seal portion 15 composed of the strong fusion portion 15a and the weak fusion portion 15c as described above is superior in heat resistance to the thermoplastic film to be used in addition to such a method, and is formed as a strong fusion. A method using a film mold in which a hole corresponding to the wearing portion 15a is formed is also possible. That is, by heating the thermoplastic resin film through such a mold, the portion corresponding to the hole becomes the strongly fused portion 15a that is strongly fused, and the other portion becomes the weakly fused portion 15c.
[0037]
[Reference example 2]
  FIG.Reference Example 2The weak seal part 15 in the multi-chamber infusion container 10 is shown.
  The weak seal portion 15 in this example is also formed by sandwiching two overlapped thermoplastic resin films from two sides of the two heat seal bars. And a weakly fused portion 15c.
  Among these, the strong fusion portion 15 a having a high fusion strength is formed in a substantially square shape, and the weak fusion portion 15 c having a low fusion strength is the entire portion other than the strong fusion portion 15 a in the weak seal portion 15.
  Also in this example, the strong fusion part 15a is formed so that the total occupied area is less than 25% of the entire area of the weak seal part 15, and as a result, the opening strength of the weak seal part 15 is moderate. Is controlled.
[0038]
Such a weak seal portion 15 of the multi-chamber infusion container 10 includes a heat seal bar having a plurality of substantially square convex surfaces 24a distributed in a lattice pattern at regular intervals, indicated by reference numeral 24 in FIG. It can be formed by sandwiching two superposed thermoplastic films from both sides with a heat seal bar having a flat seal surface (not shown) in which no seal edge is formed, and a seal edge 24a made of a convex surface. Then, the portion that is sandwiched between the flat sealing surfaces and pressed is strongly fused portion 15a. The portion where only the flat seal surface of the heat seal bar contacts from one surface side is a weakly fused portion 15c that is weakly fused.
Also in this case, it is easy to select and use the heat seal bar so that the total occupied area of the strongly fused portion 15a formed in this way is less than 25% of the entire weakly sealed portion 15. In addition, a stable weak seal portion 15 having a constant peel strength can be formed. Even when such a heat seal bar is used, the area of the seal edge 24a made of a convex surface is 1 mm.2The following is preferable.
[0039]
The weak seal portion 15 of the multi-chamber infusion container 10 of this example formed in this way has a seal edge of the heat seal bar made of a thermoplastic resin, as shown in a sectional view taken along line IV-IV ′ of FIG. By contacting the film, a concave portion, specifically, a concave surface 22b is formed only on one surface. In the case of this example, this part is the strong fusion part 15a.
The concave surface 22b thus formed has an area of 1 mm.2When formed from the heat seal bar 24 having the seal edge 24a having the following convex surface, the area is also approximately 1 mm.2It becomes as follows.
[0040]
When forming the weak seal portion 15 of this example, first, the entire portion forming the weak seal portion 15 is heat-sealed with a planar seal surface (not shown) in which no seal edge is formed. Even with the method of further sealing with a heat seal bar having seal edges 24a made up of a large number of substantially square convex surfaces distributed in a lattice pattern at equal intervals, indicated by reference numeral 24, the strong welded portion 15a and the weakly bonded portion 15a are weakly bonded. The fused portion 15c can be formed
[0041]
  In the multi-chamber infusion container 10 of the present invention,In particular, the weak seal portion 15 has different fusion strength.Three kindsThe fusion-bonding portions 15a having the fusion-bonding portion having the largest fusion strength are distributed and distributed in the weak seal portion 15 and the total occupied area is weakly sealed. Since it is controlled to be less than 25% of the area of the portion 15, the opening strength of the weak seal portion 15 is moderately controlled, and the drug chambers 11 and 12 are normally kept liquid-tight while the drug chamber is When a force is applied to 11 and 12 from the outside, it can be easily opened. Moreover, even if a single layer film having crystallinity is used as the thermoplastic resin film, sealing is performed at a temperature near the melting point, and the heat seal temperature slightly varies, the weak seal portion 15 It is possible to stably produce the multi-chamber infusion container 10 having a constant performance while minimizing variation in the opening strength.
[0042]
【Example】
Hereinafter, the present invention will be specifically described with reference to examples.
[Example 1]
Linear low density polyethylene (MFR: 2 g / 10 min (190 ° C.), density 0.925 g / cm by water-cooled inflation method3JIS A film having a thickness of 300 μm made of K6760) was prepared.
Two films are stacked and sandwiched by two heat seal bars from both sides to form a weak seal 15 that can be peeled and opened and a strong seal 16 that does not peel, as shown in FIG. The same form as the multi-chamber infusion container 10 was manufactured. In addition, the weak seal part 15 was formed in the center part of the length direction of the multi-chamber infusion container 10 by 10 mm length. In addition, the two heat seal bars used at this time were formed with a large number of protruding seal edges substantially in parallel as shown in FIG. 4, and the seal edge width W was 0.2 mm, The distance P was 2 mm, the edge angle α was 90 °, and the total occupied area of the strongly fused portion 15a in the weak seal portion 15 was 4%. The sealing conditions were a sealing pressure of 0.39 MPa, a sealing time of 4 seconds, and a heat sealing temperature of 118 ° C., 119 ° C., and 120 ° C .. That is, three multi-chamber infusion containers 10 that differ only in the heat seal temperature were manufactured.
[0043]
The drug chambers 11 and 12 of the two multi-chamber infusion containers 10 formed in this way were each filled with 1000 mL of colored water instead of the drug, and then a compression tester (Orientec Co., Ltd .: RTC1250A) was used, and 100 mm One drug chamber 11, 12 was pressed at a speed of 500 mm / min with a flat plate of × 100 mm. And the load at the time of the weak seal part 15 opening was measured, and this was made into the opening strength of the weak seal part 15. FIG.
As a result, the opening strength of the weak seal portion 15 in the thus obtained multi-chamber infusion container 10 is 253N at a heat seal temperature of 118 ° C, 760N at a temperature of 119 ° C, and 1267N at a temperature of 120 ° C. The rate of increase in opening strength at 300 to 1000 N (change in opening strength per 1 ° C.) was as small as 507 N / ° C., and it was found that the opening strength did not change greatly even if the heat seal temperature slightly changed.
Furthermore, after putting 1000 mL of colored water into both drug chambers 11 and 12 of these multi-chamber infusion containers 10 respectively, this was placed on a flat table, and both drug chambers 11 and 12 were placed. When pressed by hand five times in total, the entire weak seal portion 15 was peeled (the peeled-off whole within 5 times is indicated by openness in Table 1). Moreover, the width W 'and distance P' (refer FIG. 6) of the groove in the weak seal part 15 of the formed multi-chamber infusion container 10 are 2 mm and 0.4 mm, respectively, and the average space | interval in said Formula (1) A and average distance B were 1.6 mm and 2 mm, respectively. In addition, these measurements were performed using the photograph which image | photographed the weak seal | sticker part 15 by 20 time magnification.
The above results are summarized in Tables 1 and 2.
[0044]
[Example 2]
Except that the width W of the seal edge of the two heat seal bars used was 0.2 mm, the distance P was 4 mm, the edge angle α was 90 °, and the heat seal temperatures were 120 ° C., 121 ° C. and 122 ° C. In the same manner as in Example 1, three types of multi-chamber infusion containers 10 were produced. The total occupied area of the strong fusion bonding portion 15a in the weak seal portion 15 was 0.6%.
Table 1 and Table 2 show the results of evaluation in the same manner as in Example 1.
As shown in Table 2, it was found that the opening strength increase rate at the opening strength of 300 to 1000 N is small, and the opening strength does not change greatly even if the heat seal temperature varies slightly. Moreover, the patency was also good.
[0045]
[Comparative Example 1]
Example 1 except that the width W of the seal edge of the two heat seal bars used was 0.4 m, the distance P was 1 mm, the edge angle α was 90 °, and the heat seal temperatures were 117 ° C. and 118 ° C. Similarly, two types of multi-chamber infusion containers 10 were manufactured. The total occupied area of the strongly fused portion 15a in the weak seal portion 15 was 25% in all cases.
Table 1 and Table 2 show the results of evaluation in the same manner as in Example 1.
As shown in Table 2, it was found that the opening strength increase rate at the opening strength of 300 to 1000 N was large, and the opening strength changed greatly even when the heat seal temperature slightly changed. Moreover, about the patency, the weak seal part 15 did not exfoliate partially but was not favorable (it shows by x in Table 2).
[0046]
[Comparative Example 2]
Example 1 except that the width W of the seal edge of the two heat seal bars used is 0.2 m, the distance P is 2 mm, the edge angle α is 150 °, and the heat seal temperature is 117 ° C. and 118 ° C. Similarly, two types of multi-chamber infusion containers 10 were manufactured. The total occupied area of the strongly fused portion 15a in the weak seal portion 15 was 30% in all cases.
Table 1 and Table 2 show the results of evaluation in the same manner as in Example 1.
As shown in Table 2, it was found that the opening strength increase rate at the opening strength of 300 to 1000 N was large, and the opening strength changed greatly even when the heat seal temperature slightly changed. Moreover, about the patency, the weak seal part 15 did not exfoliate partially but was not favorable.
[0047]
[Reference test example 1]
  As the two heat seal bars, as shown in FIG. 9, a combination of a seal edge having a convex stripe and a seal edge having a convex surface (a square one uniformly exists in a lattice shape) was used in combination. All of these seal edges had a width W of 0.2 mm, a distance P4 mm, and an edge angle α90 °. And the three types of multi-chamber infusion container 10 was manufactured like Example 1 except heat seal temperature having been 118 degreeC, 119 degreeC, and 120 degreeC. The total occupied area of the strongly fused portion 15a in the weak seal portion 15 was 8% in all cases.
  Table 1 and Table 2 show the results of evaluation in the same manner as in Example 1.
  As shown in Table 2, it was found that the opening strength increase rate at the opening strength of 300 to 1000 N is small, and the opening strength does not change greatly even if the heat seal temperature varies slightly. Moreover, the patency was also good.
  In Table 1, average distance A1And average distance B1As shown in FIG. 8, the average distance A is measured between the strongly fused portions 15a which are concave surfaces.2And average distance B2Is measured between the concave surface and the strongly fused portion 15a of the concave stripe.
[0048]
[Reference test example 2]
  As two heat seal bars, one has a shape indicated by reference numeral 24 in FIG. 9 in which the seal edge is a convex surface (square), and the other has a flat seal surface without a seal edge. Used in combination. Note that the sealing edge, which is a convex surface, had a width W of 0.2 mm, a distance P2 mm, and an edge angle of 60 °.
  And the three types of multi-chamber infusion container 10 was manufactured like Example 1 except heat seal temperature having been 120 degreeC, 121 degreeC, and 122 degreeC. The total occupied area of the strongly fused portion 15a in the weak seal portion 15 was 1% in all cases.
  Table 1 and Table 2 show the results of evaluation in the same manner as in Example 1.
  As shown in Table 2, it was found that the opening strength increase rate at the opening strength of 300 to 1000 N is small, and the opening strength does not change greatly even if the heat seal temperature varies slightly. Moreover, the patency was also good.
[0049]
[Comparative Example 3]
Two heat seal bars were used in combination with a flat seal surface having no seal edge. Then, two types of multi-chamber infusion containers 10 were produced in the same manner as in Example 1 except that the heat seal temperature was changed to two types of 117 ° C. and 118 ° C. The total occupied area of the strongly fused portion 15a in the weak seal portion 15 was 100%.
As shown in Table 2, it was found that the opening strength increase rate at the opening strength of 300 to 1000 N was large, and the opening strength changed greatly even when the heat seal temperature slightly changed. Moreover, about the patency, the weak seal part 15 did not exfoliate partially but was not favorable.
[0050]
[Table 1]
Figure 0004298308
[0051]
[Table 2]
Figure 0004298308
[0052]
  Also,In each exampleIn all of the obtained multi-chamber infusion containers 10, no leakage of the liquid to the weak seal portion 15 was visually observed after filling the drug chambers 11 and 12 with the liquid.
[0053]
【The invention's effect】
As described above, in the multi-chamber infusion container of the present invention, the total occupied area of the strong fusion part in the weak seal part is less than 25%. A multi-chamber infusion container having a stable peel strength at the boundary between the drug chamber and the drug chamber is obtained. Moreover, according to the manufacturing method of the present invention, such a multi-chamber infusion container can be easily manufactured with high productivity.
[Brief description of the drawings]
FIG. 1 is a plan view showing an example of a multi-chamber infusion container of the present invention.
FIG. 2 is a plan view in which a weak seal portion of the multi-chamber infusion container of FIG. 1 is partially enlarged.
FIG. 3 is a plan view in which the weak seal portion of the multi-chamber infusion container of FIG. 1 is further partially enlarged.
4 is a perspective view of a heat seal bar used for forming a weak seal portion of the multi-chamber infusion container of FIG. 1. FIG.
FIG. 5 is a cross-sectional view taken along V-V ′ in FIG. 4;
6A is a cross-sectional view taken along the line I-I ′ in FIG. 3, and FIG. 6B is a cross-sectional view taken along the line II-II ′.
[Fig. 7]Reference Example 1It is the top view which expanded the weak seal part in a multi-chamber infusion container partially.
FIG. 8 is a plan view similar to FIG.
9 is a perspective view of a heat seal bar used for forming the weak seal portion of the multi-chamber infusion container of FIG. 7. FIG.
10 is a cross-sectional view taken along line III-III 'in FIG.
FIG. 11Reference Example 2It is the top view which expanded the weak seal part in a multi-chamber infusion container partially.
12 is a cross-sectional view taken along the line IV-IV 'in FIG.
[Explanation of symbols]
  10 Double-chamber infusion container
  11,12 drug room
  15 Weak seal
  15a Strong fusion part
  16 Strong seal
  20, 21 Heat seal bar
  22a concave
  22b Concave
  23, 24 Heat seal bar

Claims (12)

熱可塑性樹脂フィルムから形成され、薬剤を収容する複数の薬剤室を有する複室輸液容器であって、
各薬剤室同士は、剥離可能な弱シール部で液密にシールされ、
前記弱シール部は融着強度の異なる３種類の融着部を有して形成され、
これら融着部のうち最も融着強度の大きな強融着部は、
当該弱シール部の両面に形成された凹部の一部であり、当該弱シール部で分散して分布し、かつ、その占有面積の合計が当該弱シール部の面積の２５％未満であることを特徴とする複室輸液容器。A multi-chamber infusion container formed of a thermoplastic resin film and having a plurality of drug chambers for containing drugs,
Each drug room is sealed in a liquid-tight manner with a weak seal that can be peeled off
The weak seal portion is formed having three types of fusion portions having different fusion strengths,
Among these fusion parts, the strong fusion part with the largest fusion strength is
It is a part of the concave portions formed on both surfaces of the weak seal portion, is distributed and distributed in the weak seal portion, and the total occupied area is less than 25% of the area of the weak seal portion. Features a multi-chamber infusion container. 各強融着部は、近接する強融着部間の平均間隔Ａと平均距離Ｂとが下記式（１）を満たすように分布していることを特徴とする請求項１に記載の複室輸液容器。
Ｂ＜２Ａ・・・（１）2. The multi-chamber according to claim 1, wherein each strongly fused portion is distributed such that an average interval A and an average distance B between adjacent strongly fused portions satisfy the following formula (1): Infusion container.
B <2A (1) 強融着部間の前記平均距離Ｂが１．０ｍｍ以上であることを特徴とする請求項２に記載の複室輸液容器。  The multi-chamber infusion container according to claim 2, wherein the average distance B between the strongly fused portions is 1.0 mm or more. 各強融着部は、面積１ｍｍ２以下の面であることを特徴とする請求項１ないし３のいずれかに記載の複室輸液容器。The multi-chamber infusion container according to any one of claims 1 to 3, wherein each strongly fused portion is a surface having an area of 1 mm 2 or less. 前記凹部は、略平行に形成された幅１ｍｍ以下の複数の凹条からなることを特徴とする請求項１ないし４のいずれかに記載の複室輸液容器。The multi-chamber infusion container according to any one of claims 1 to 4, wherein the concave portion comprises a plurality of concave strips having a width of 1 mm or less formed substantially in parallel. 各強融着部の分布状態が、弱シール部の幅方向で異なっていることを特徴とする請求項１ないし５のいずれかに記載の複室輸液容器。The multi-chamber infusion container according to any one of claims 1 to 5, wherein the distribution state of each strongly fused portion is different in the width direction of the weak seal portion. 薬剤を収容する複数の薬剤室を有し、各薬剤室同士が剥離可能な弱シール部で液密にシールされた複室輸液容器の製造方法であって、
重ねられた２枚の熱可塑性樹脂フィルムを両面側から、シール面にシールエッジが形成されている２本のヒートシールバーで挟持し、融着強度の異なる３種類の融着部を有する弱シール部を形成する弱シール工程を有し、
該弱シール工程は、前記融着部のうち最も融着強度が大きく、前記弱シール部内で分散して分布する強融着部の占有面積の合計が、当該弱シール部の面積の２５％未満となるようになされることを特徴とする複室輸液容器の製造方法。A method for producing a multi-chamber infusion container having a plurality of drug chambers for storing drugs and liquid-tightly sealed with a weak seal portion where each drug chamber can be peeled off,
A weak seal having three types of fused portions with different fusion strengths, sandwiched between two thermoplastic resin films from both sides , with two heat seal bars with seal edges formed on the seal surface Having a weak sealing process to form the part,
The weak sealing step has the highest fusion strength among the fused portions, and the total occupied area of the strong fused portions distributed and distributed in the weak sealed portion is less than 25% of the area of the weak sealed portion. A method for producing a multi-chamber infusion container, characterized in that: 前記シールエッジは、略平行に形成された幅１ｍｍ以下の複数の凸条からなることを特徴とする請求項７に記載の複室輸液容器の製造方法。The method for manufacturing a multi-chamber infusion container according to claim 7 , wherein the seal edge is composed of a plurality of protrusions having a width of 1 mm or less formed substantially in parallel. 各シールエッジ間の平均距離が、１．０ｍｍ以上であることを特徴とする請求項７または８に記載の複室輸液容器の製造方法。The method for producing a multi-chamber infusion container according to claim 7 or 8 , wherein an average distance between the seal edges is 1.0 mm or more. 各シールエッジのエッジ角度が、１２０度以下であることを特徴とする請求項７ないし９のいずれかに記載の複室輸液容器の製造方法。The method for producing a multi-chamber infusion container according to any one of claims 7 to 9 , wherein an edge angle of each seal edge is 120 degrees or less. 当該複室輸液容器の周縁の少なくとも一部を両面側からヒートシールバーで挟持し、該周縁部を液密に閉じる強シール工程を有し、
該強シール工程と、前記弱シール工程とが同時になされることを特徴とする請求項７ないし１０のいずれかに記載の複室輸液容器の製造方法。Sandwiching at least a part of the peripheral edge of the multi-chamber infusion container from both sides with a heat seal bar, and having a strong sealing step of closing the peripheral edge liquid-tightly,
The method for producing a multi-chamber infusion container according to any one of claims 7 to 10 , wherein the strong sealing step and the weak sealing step are performed simultaneously. 弱シール工程は、ヒートシール温度に対する弱シール部の開通強度上昇率が、１０００Ｎ／℃以下となるようになされることを特徴とする請求項７ないし１１のいずれかに記載の複室輸液容器の製造方法。Weak seal step, opening the intensity increase rate of the weak seal part with respect to the heat sealing temperature is, 1000 N / ° C. to claims 7 characterized in that it is made such that the following infusion container with multiple chambers as claimed in any one of the 11 Production method.
JP2003023436A 2002-03-28 2003-01-31 Multi-chamber infusion container and manufacturing method thereof Expired - Lifetime JP4298308B2 (en)

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JP2003023436A JP4298308B2 (en) 2002-03-28 2003-01-31 Multi-chamber infusion container and manufacturing method thereof
TW92107021A TWI252203B (en) 2002-03-28 2003-03-26 Infusion container with multiple chambers and production method thereof
AT03745425T ATE468963T1 (en) 2002-03-28 2003-03-27 MULTIPLE-CHAMBER INFUSION CONTAINER AND PRODUCTION METHOD THEREOF
DE60332710T DE60332710D1 (en) 2002-03-28 2003-03-27 INFUSION TANK WITH SEVERAL CHAMBERS AND METHOD OF MANUFACTURING THEREOF
CNB038069997A CN100344439C (en) 2002-03-28 2003-03-27 Infusion container with multiple chambers and production method thereof
PT03745425T PT1490207E (en) 2002-03-28 2003-03-27 Infusion container with multiple chambers and production method thereof
EP03745425A EP1490207B1 (en) 2002-03-28 2003-03-27 Infusion container with multiple chambers and production method thereof
PCT/JP2003/003854 WO2003082549A1 (en) 2002-03-28 2003-03-27 Infusion container with multiple chambers and production method thereof
US10/508,481 US7776414B2 (en) 2002-03-28 2003-03-27 Infusion container with multiple chambers
KR1020047014967A KR100659650B1 (en) 2002-03-28 2003-03-27 Infusion container with multiple chambers and production method thereof
AU2003226480A AU2003226480A1 (en) 2002-03-28 2003-03-27 Infusion container with multiple chambers and production method thereof
ES03745425T ES2344891T3 (en) 2002-03-28 2003-03-27 INFUSION CONTAINER WITH MULTIPLE CAMERAS AND ITS PRODUCTION PROCEDURE.
US12/829,941 US20100269972A1 (en) 2002-03-28 2010-07-02 Infusion container with multiple chambers

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WO2006057442A1 (en) 2004-11-26 2006-06-01 Hosokawa Yoko Co., Ltd. Medical liquid container and preparation-containing medical liquid container
JP4749057B2 (en) * 2005-06-30 2011-08-17 三井化学株式会社 Multi-chamber infusion container and manufacturing method thereof
JP4689416B2 (en) * 2005-09-13 2011-05-25 三井化学株式会社 Multi-chamber container
JP5973118B2 (en) * 2005-11-10 2016-08-23 田辺三菱製薬株式会社 Plastic container filled with aqueous solution containing pyrazolone compound
JP2007143892A (en) * 2005-11-28 2007-06-14 Jms Co Ltd Medical tray and its manufacturing method
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JP6478400B2 (en) * 2015-04-21 2019-03-06 株式会社細川洋行 Bag-shaped container, medical multi-chamber container, mold and method of forming curvilinear belt-like weak seal
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