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JP5781661B2 - Manufacturing method of medical container - Google Patents

Manufacturing method of medical container Download PDF

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Publication number
JP5781661B2
JP5781661B2 JP2014094489A JP2014094489A JP5781661B2 JP 5781661 B2 JP5781661 B2 JP 5781661B2 JP 2014094489 A JP2014094489 A JP 2014094489A JP 2014094489 A JP2014094489 A JP 2014094489A JP 5781661 B2 JP5781661 B2 JP 5781661B2
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Prior art keywords
port
weak
sealing
container body
strong
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JP2014176732A (en
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剛之 山口
剛之 山口
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TRUMO KABUSHIKI KAISHA
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TRUMO KABUSHIKI KAISHA
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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
    • 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
    • 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
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112—Single lapped joints
    • B29C66/1122—Single lap to lap joints, i.e. overlap joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/345—Progressively making the joint, e.g. starting from the middle
    • B29C66/3452—Making complete joints by combining partial joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/739—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/7392—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic
    • B29C66/73921—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic characterised by the materials of both parts being thermoplastics
    • 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
    • B29C66/81431—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 comprising a single cavity, e.g. a groove
    • 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
    • B29C66/8145—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 constructional aspects of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/81463—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 constructional aspects of the pressing elements, e.g. of the welding jaws or clamps comprising a plurality of single pressing elements, e.g. a plurality of sonotrodes, or comprising a plurality of single counter-pressing elements, e.g. a plurality of anvils, said plurality of said single elements being suitable for making a single joint
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—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
    • B29C66/83221—Joining or pressing tools reciprocating along one axis cooperating reciprocating tools, each tool reciprocating along one axis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • B29C66/91421—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the joining tools
    • B29C66/91423—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the joining tools using joining tools having different temperature zones or using several joining tools with different temperatures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • B29C66/9192—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams
    • B29C66/91921—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature
    • B29C66/91931—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature in explicit relation to the fusion temperature or melting point of the material of one of the parts to be joined
    • B29C66/91933—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature in explicit relation to the fusion temperature or melting point of the material of one of the parts to be joined higher than said fusion 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
    • 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
    • B29C65/04—Dielectric heating, e.g. high-frequency welding, i.e. radio frequency welding of plastic materials having dielectric properties, e.g. PVC
    • 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
    • B29C66/81411—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 characterised by its cross-section, e.g. transversal or longitudinal, being non-flat
    • B29C66/81421—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 characterised by its cross-section, e.g. transversal or longitudinal, being non-flat being convex or concave
    • B29C66/81423—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 characterised by its cross-section, e.g. transversal or longitudinal, being non-flat being convex or concave being concave
    • 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)
  • High Energy & Nuclear Physics (AREA)
  • Thermal Sciences (AREA)
  • Plasma & Fusion (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Bag Frames (AREA)

Description

本発明は、医療用容器の製造方法に関するものである。   The present invention relates to a method for manufacturing a medical container.

医療用容器には、例えば、点滴用の薬液を収納する輸液用容器、中心静脈に直接投与するために栄養分を収納するＩＶＨバッグ、経腸栄養剤を収納するバッグ、骨髄やリンパ球などの生体細胞を収納する細胞培養用バッグ、尿を収納する採尿バッグ、各種薬液を収納するバッグなど各種のバッグがある。これら医療用容器は、古くは硬質容器であったが、現在では、殆どが軟質容器となっている。
軟質容器は、軟質樹脂製シートにより構成された軟質バッグ(容器本体)に、排出ポート、混注ポート等を取り付けることにより作製されている。そして、軟質バッグへのポート等の取付けは、軟質樹脂製シート間にポート等を配置し、ポート等の外周面付近をシール用金型によりヒートシールすることにより行われている。
しかしながら、軟質バッグに形成されたポート等の固定対象部材取付部にポート等を配置した際、ポート等には厚みがあるので固定対象部材取付部を構成するシートにはある程度テンションがかかっている。このため、シート用金型を用いてヒートシールする際に、ポート等の外周面付近に位置するシート部分が金型の押圧に反発した状態でヒートシールされる。このため、ポート等の外周面上もしくは両側に位置するシートが肉薄になり易く、また穴あき等が発生する場合がある。そして、薬剤室収納側における穴あき（ピンホール）は、バッグ内の輸液の漏れや変質の原因となる。
そこで、本発明者は、特開２００６−２０４６１０（特許文献１）を提案している。 Medical containers include, for example, infusion containers that contain infusion drug solutions, IVH bags that contain nutrients for direct administration to the central vein, bags that contain enteral nutrients, and living organisms such as bone marrow and lymphocytes. There are various types of bags such as a cell culture bag for storing cells, a urine collection bag for storing urine, and a bag for storing various drug solutions. These medical containers have been hard containers in the past, but now most of them are soft containers.
The soft container is manufactured by attaching a discharge port, a mixed injection port, and the like to a soft bag (container body) made of a soft resin sheet. The port or the like is attached to the soft bag by arranging the port or the like between the soft resin sheets and heat-sealing the vicinity of the outer peripheral surface of the port or the like with a sealing mold.
However, when a port or the like is arranged in a fixing target member mounting portion such as a port formed in the soft bag, the port or the like has a thickness, so that a certain tension is applied to the sheet constituting the fixing target member mounting portion. For this reason, when heat-sealing using the sheet mold, the sheet portion located near the outer peripheral surface of the port or the like is heat-sealed in a state repelling the pressing of the mold. For this reason, the sheets located on the outer peripheral surface or both sides of the port or the like are likely to become thin, and perforations may occur. And the perforation (pinhole) in the chemical | medical chamber storage side causes the leakage of the infusion solution in a bag, and a quality change.
Therefore, the present inventor has proposed Japanese Patent Application Laid-Open No. 2006-204610 (Patent Document 1).

特開２００６−２０４６１０JP 2006-204610 A

特許文献１は、薬剤室を有する軟質バッグ２と固定対象部材１２，１７とを有する医療用容器１の製造方法であり、固定対象部材取付部７，８を有する軟質樹脂製シート２ａ，２ｂにより構成された軟質バッグ２と部材１２，１７とを準備する工程と、部材１２，１７を取付部７，８に配置する配置工程と、配置された部材１２，１７の外周面付近１８を圧迫して取付部７，８を構成するシート同士を近接もしくは接触させる圧迫工程と、圧迫工程による圧迫を維持した状態で圧迫された部分１８よりも軟質バッグ周縁側の取付部付近１９にて部材１２，１７を軟質バッグ２にヒートシールする工程を備える。
上記のものでも十分な効果を有するが、薬剤室収納側における穴あき（ピンホール）の発生防止をより確実に防止できるものが求められていた。
そこで、本発明は、ポート固定部の薬剤室側における穴あき（ピンホール）の発生防止をより確実に防止することができる医療用容器の製造方法を提供する。 Patent document 1 is a manufacturing method of the medical container 1 which has the soft bag 2 which has a chemical | medical agent chamber, and the fixing target members 12 and 17, and is based on soft resin sheet 2a, 2b which has the fixing target member attaching part 7 and 8. A step of preparing the configured soft bag 2 and the members 12, 17; an arrangement step of arranging the members 12, 17 on the attachment portions 7, 8; and pressing the vicinity of the outer peripheral surface 18 of the arranged members 12, 17 The member 12 in the vicinity of the attachment portion 19 on the peripheral side of the soft bag rather than the portion 18 pressed in a state in which the sheets constituting the attachment portions 7 and 8 are brought close to or in contact with each other and the compression in the compression step is maintained. 17 is heat-sealed to the soft bag 2.
Although the above-described one has a sufficient effect, there has been a demand for one that can more reliably prevent the occurrence of perforation (pinhole) on the medicine chamber storage side.
Therefore, the present invention provides a method for manufacturing a medical container that can more reliably prevent the occurrence of perforation (pinhole) on the drug chamber side of the port fixing portion.

上記目的を達成するものは、以下のものである。
（１） 熱可塑性樹脂製材料により作製され、内部に薬剤室を有する容器本体と、前記容器本体の前記薬剤室と連通するように設けられた熱可塑性樹脂製硬質ポートとを備える医療用容器の製造方法であって、
前記医療用容器の製造方法は、弱シール金型部と、前記弱シール金型部と別個に移動可能な強シール金型部とを備えるヒートシール装置を準備する工程と、ポート取付部を有する熱可塑性樹脂製材料により構成された軟質容器本体を準備する工程と、前記熱可塑性樹脂製硬質ポートを準備する工程と、前記硬質ポートの一端側を前記容器本体のポート取付部に挿入するポート挿入工程と、前記ポート挿入工程により挿入された前記硬質ポートより前記容器本体内の空気を吸引する吸引工程と、前記挿入工程により挿入された前記硬質ポートの端部を前記容器本体に、前記ヒートシール装置の前記弱シール金型部を用いて弱シールする弱シール工程と、前記挿入工程により挿入された前記硬質ポートの前記弱シール工程により弱シールされた部分に近接しかつ前記容器本体の外縁側となる部分に、前記ヒートシール装置の前記強シール金型部を当接させ、前記弱シールより高い温度にて前記容器本体にヒートシールする強シール工程とを備え、さらに、前記吸引工程の開始は、前記弱シール工程の開始より先であり、かつ、前記弱シール工程の開始時には、前記吸引工程が継続しており、さらに、前記強シール工程は、前記弱シール工程の開始後かつ前記弱シール工程の継続中に開始されるものである医療用容器の製造方法。 What achieves the above object is as follows.
(1) A medical container comprising a container body made of a thermoplastic resin material and having a drug chamber therein, and a thermoplastic resin hard port provided to communicate with the drug chamber of the container body A manufacturing method comprising:
The method for manufacturing a medical container includes a step of preparing a heat seal device including a weak seal mold part and a strong seal mold part that can be moved separately from the weak seal mold part, and a port mounting part. A step of preparing a flexible container body made of a thermoplastic resin material, a step of preparing the thermoplastic resin hard port, and a port insertion for inserting one end of the hard port into a port mounting portion of the container body A suction step of sucking air in the container body from the hard port inserted in the port insertion step, and an end portion of the hard port inserted in the insertion step in the container body, and the heat seal the weak and weak seal step of weak sealed using a sealing mold portion, said being by Ri weak seal the weak seal step of said rigid port inserted by the insertion step parts of the apparatus To close and partially as a outer edge of said container body, said abut the strong seal mold portion of the heat-sealing device, a strong seal step of heat-sealing to the container body at said higher weak seal temperature Further, the start of the suction step is ahead of the start of the weak sealing step, and at the start of the weak sealing step, the suction step is continued, and the strong sealing step is A method for manufacturing a medical container, which is started after the start of the weak sealing step and during the continuation of the weak sealing step .

（２） 前記吸引工程は、少なくとも前記強シール工程開始時まで行うものである上記（１）に記載の医療用容器の製造方法。
（３） 前記吸引工程は、少なくとも前記強シール工程終了時まで行うものである上記（１）に記載の医療用容器の製造方法。
（４） 前記強シール工程は、前記弱シール工程の開始後に開始され、かつ前記弱シール工程終了前に終了するものである上記（１）ないし（３）のいずれかに記載の医療用容器の製造方法。
（５） 前記医療用容器の製造方法は、前記強シール工程後、強シールされた部分を冷却する冷却工程を備えている上記（１）ないし（４）のいずれかに記載の医療用容器の製造方法。
（６） 前記医療用容器の製造方法は、前記強シール工程後、強シールされた部分を冷却する冷却工程を備え、前記強シール工程は、前記弱シール工程の開始後に開始され、かつ前記弱シール工程終了前に終了するものであり、前記冷却工程は、前記弱シール工程継続中に開始しかつ前記弱シール工程終了前に終了するものである上記（１）ないし（５）のいずれかに記載の医療用容器の製造方法。
（７） 前記弱シール工程は、前記硬質ポートの弱シールされる外周面部分を前記容器本体の両面側から圧迫して行うものであり、前記冷却工程は、前記弱シール工程における前記圧迫を保持した状態で行われるものである上記（６）に記載の医療用容器の製造方法。
（８） 前記吸引工程は、前記弱シール工程終了時まで行うものである上記（２）ないし（７）のいずれかに記載の医療用容器の製造方法。
（９） 前記硬質ポートは、排出ポートもしくは混注ポートである上記（１）ないし（８）のいずれかに記載の医療用容器の製造方法。 (2) The method for producing a medical container according to (1), wherein the suction step is performed at least until the start of the strong sealing step.
(3) The method for producing a medical container according to (1), wherein the suction step is performed at least until the end of the strong sealing step.
(4) The medical container according to any one of (1) to (3), wherein the strong sealing step is started after the start of the weak sealing step and ends before the end of the weak sealing step. Production method.
(5) The manufacturing method of the medical container according to any one of (1) to (4), further including a cooling step of cooling the strongly sealed portion after the strong sealing step. Production method.
(6) The method for manufacturing a medical container includes a cooling step for cooling a strongly sealed portion after the strong sealing step, and the strong sealing step is started after the weak sealing step is started, and the weak sealing step is performed. Any of the above (1) to (5) is completed before the end of the sealing step, and the cooling step starts while the weak sealing step continues and ends before the end of the weak sealing step. The manufacturing method of the medical container as described.
(7) The weak sealing step is performed by pressing a weakly sealed outer peripheral surface portion of the hard port from both sides of the container body, and the cooling step holds the compression in the weak sealing step. The manufacturing method of the medical container as described in said (6) performed in the state which carried out.
(8) The method for manufacturing a medical container according to any one of (2) to (7), wherein the suction step is performed until the end of the weak sealing step.
(9) The method for manufacturing a medical container according to any one of (1) to (8), wherein the hard port is a discharge port or a mixed injection port.

本発明の医療用容器の製造方法は、ポート取付部を有する熱可塑性樹脂製材料により構成された軟質容器本体を準備する工程と、熱可塑性樹脂製ポートを準備する工程と、ポートの一端側を容器本体のポート取付部に挿入する挿入工程と、挿入工程により挿入されたポートの端部を容器本体にヒートシールにより弱シールする弱シール工程と、挿入工程により挿入されたポートの弱シール工程による弱シールされる部分に近接しかつ容器本体の外縁側となる部分を弱シールより高い温度にて容器本体にヒートシールする強シール工程とを備えている。
このため、本発明の医療用容器の製造方法によれば、ポート取付部へのポート固定時における当該固定部での容器本体の薄肉化を確実に防止し、薄肉化に起因するピンホールの発生を防止する。
また、本発明の医療用容器は、上記製造方法により製造される医療用容器である。このため、本発明の医療用容器は、ポート取付部へのポート固定時における当該固定部での容器本体の薄肉化が極めて少なく、薄肉化に起因するピンホールの発生が極めて少ない。
また、本発明の医療用容器は、熱可塑性樹脂製材料により作製され、内部に薬剤室を有する容器本体と、容器本体の薬剤室と連通するように設けられた熱可塑性樹脂製ポートとを備えるものであり、かつ、容器本体は、ポート取付部を備え、ポートは、一端側が前記ポート取付部内に挿入された状態にて、ヒートシールにより形成された固定部により容器本体に固定されており、かつ、固定部は、薬剤室側に設けられた弱シール部と、弱シール部に近接しかつ容器本体の外縁側に位置し、かつ弱シール部よりシール強度が高い強シール部とを備えている。
このため、本発明の医療用容器は、ポート取付部へのポート固定部の端部が弱シール部となっているため、当該部分でのピンホールの発生が極めて少ない。また、ポート端部をヒートシールすると、シートのしわが大きいので、特にピンホールが生じやすいが、ポート端部を弱シールとしたので、ピンホールが生じることなくポート端部をシールでき、薬液充填後も弱シールが維持されている場合は、バッグ内部へのポートの突出が押えられ、投与時の残液量をなくすことができる。 The method for manufacturing a medical container according to the present invention includes a step of preparing a soft container body made of a thermoplastic resin material having a port mounting portion, a step of preparing a thermoplastic resin port, and one end side of the port. Insertion process of inserting into the port mounting portion of the container body, weak sealing process of weakly sealing the end of the port inserted by the insertion process to the container body by heat sealing, and weak sealing process of the port inserted by the insertion process A strong sealing step of heat-sealing the portion close to the weakly sealed portion and on the outer edge side of the container main body to the container main body at a temperature higher than the weak seal.
For this reason, according to the method for manufacturing a medical container of the present invention, when the port is fixed to the port mounting portion, it is possible to reliably prevent the thinning of the container body at the fixing portion and to generate a pinhole due to the thinning. To prevent.
Moreover, the medical container of this invention is a medical container manufactured by the said manufacturing method. For this reason, in the medical container of the present invention, when the port is fixed to the port mounting portion, the container main body is very thin at the fixing portion, and the occurrence of pinholes due to the thinning is extremely small.
The medical container of the present invention is made of a thermoplastic resin material, and includes a container body having a drug chamber therein and a thermoplastic resin port provided so as to communicate with the drug chamber of the container body. And the container body includes a port mounting portion, and the port is fixed to the container body by a fixing portion formed by heat sealing in a state where one end side is inserted into the port mounting portion. The fixing portion includes a weak seal portion provided on the drug chamber side, and a strong seal portion located near the weak seal portion and on the outer edge side of the container body and having a higher seal strength than the weak seal portion. Yes.
For this reason, in the medical container of the present invention, the end portion of the port fixing portion to the port mounting portion is a weak seal portion, so that pinholes are hardly generated in the portion. In addition, when the port end is heat sealed, the wrinkles of the sheet are large, so pinholes are particularly likely to occur. However, since the port end is weakly sealed, the port end can be sealed without generating pinholes and filled with chemicals. If a weak seal is maintained afterwards, the projection of the port into the bag is suppressed, and the amount of remaining liquid at the time of administration can be eliminated.

図１は、本発明の実施例である医療用容器の正面図である。FIG. 1 is a front view of a medical container that is an embodiment of the present invention. 図２は、図１に示した医療用容器のＡ−Ａ線断面拡大図である。FIG. 2 is an enlarged cross-sectional view taken along line AA of the medical container shown in FIG. 図３は、図１に示した医療用容器の排出ポート付近の拡大図である。FIG. 3 is an enlarged view of the vicinity of the discharge port of the medical container shown in FIG. 図４は、図１に示す医療用容器に用いられる容器本体の正面図である。FIG. 4 is a front view of a container main body used for the medical container shown in FIG. 図５は、本発明の医療用容器の製造方法の実施例を説明するためのフローチャートである。FIG. 5 is a flowchart for explaining an embodiment of the method for producing a medical container of the present invention. 図６は、本発明の医療用容器の製造方法に用いられるヒートシール装置の斜視図である。FIG. 6 is a perspective view of a heat seal device used in the method for producing a medical container of the present invention. 図７は、本発明の医療用容器の製造方法の実施例を説明するための説明図である（ポート挿入工程）。FIG. 7 is an explanatory diagram for explaining an embodiment of the method for manufacturing a medical container of the present invention (port insertion step). 図８は、本発明の医療用容器の製造方法の実施例を説明するための説明図である（吸引工程）。FIG. 8 is an explanatory view for explaining an embodiment of the method for producing a medical container of the present invention (suction process). 図９は、本発明の医療用容器の製造方法の実施例を説明するための説明図である（弱シール工程）。FIG. 9 is an explanatory diagram for explaining an embodiment of the method for producing a medical container of the present invention (weak sealing process). 図１０は、本発明の医療用容器の製造方法の実施例を説明するための説明図である（強シール工程）。FIG. 10 is an explanatory view for explaining an embodiment of the method for producing a medical container of the present invention (strong sealing process). 図１１は、本発明の医療用容器の製造方法の実施例を説明するための説明図である（冷却工程）。FIG. 11 is an explanatory view for explaining an embodiment of the method for producing a medical container of the present invention (cooling step). 図１２は、本発明の医療用容器の製造方法の実施例を説明するための説明図である。FIG. 12 is explanatory drawing for demonstrating the Example of the manufacturing method of the medical container of this invention. 図１３は、本発明の医療用容器の製造方法の実施例の弱シール工程を説明するための説明図（弱シールされる部分における断面図）である。FIG. 13 is an explanatory view (a cross-sectional view of a weakly sealed portion) for explaining a weak sealing step of an embodiment of the method for manufacturing a medical container of the present invention. 図１４は、本発明の医療用容器の製造方法の実施例の弱シール工程を説明するための説明図である（弱シールされる部分における断面図）である。FIG. 14 is an explanatory view for explaining the weak sealing step of the embodiment of the manufacturing method of the medical container according to the present invention (a cross-sectional view of a weakly sealed portion).

本発明の実施例である医療用容器の製造方法および医療用容器について添付図面を用いて説明する。
本発明の医療用容器の製造方法は、熱可塑性樹脂製材料により作製され、内部に薬剤室３を有する容器本体と、容器本体の薬剤室と連通するように設けられた熱可塑性樹脂製排出ポートとを備える医療用容器の製造方法である。
本発明の医療用容器の製造方法は、ポート取付部７を有する熱可塑性樹脂製材料により構成された軟質容器本体２を準備する工程と、熱可塑性樹脂製ポート１２を準備する工程と、ポート１２の一端側を容器本体２のポート取付部７に挿入するポート挿入工程と、ポート挿入工程により挿入されたポート１２の端部を容器本体２にヒートシールにより弱シールする弱シール工程と、ポート挿入工程により挿入されたポートの弱シール工程による弱シールされる部分に近接しかつ容器本体の外縁側となる部分を弱シールより高い温度にて容器本体にヒートシールする強シール工程とを備える。
そして、本発明の医療用容器は、本発明の医療用容器の製造方法により製造される医療用容器である。
また、本発明の医療用容器１は、熱可塑性樹脂製材料により作製され、内部に薬剤室を有する容器本体２と、容器本体２の薬剤室３と連通するように設けられた熱可塑性樹脂製ポート１２とを備える医療用容器である。そして、容器本体２は、ポート取付部７を備え、ポート１２は、一端側がポート取付部内に挿入された状態にて、ヒートシールにより形成された固定部により容器本体に固定されており、かつ、固定部１６は、薬剤室側に設けられた弱シール部１８と、弱シール部１８に近接しかつ容器本体２の外縁側に位置し、かつ弱シール部１８よりシール強度が高い強シール部１９とを備えている。 A method for manufacturing a medical container and a medical container according to an embodiment of the present invention will be described with reference to the accompanying drawings.
The method for producing a medical container of the present invention is made of a thermoplastic resin material, and includes a container body having a drug chamber 3 therein, and a thermoplastic resin discharge port provided so as to communicate with the drug chamber of the container body. Is a method for manufacturing a medical container.
The method for manufacturing a medical container according to the present invention includes a step of preparing a flexible container body 2 made of a thermoplastic resin material having a port attachment portion 7, a step of preparing a thermoplastic resin port 12, and a port 12. A port insertion step of inserting one end side into the port mounting portion 7 of the container body 2, a weak sealing step of weakly sealing the end portion of the port 12 inserted in the port insertion step to the container body 2 by heat sealing, and port insertion A strong sealing step of heat-sealing the portion of the port inserted in the process close to the weakly sealed portion by the weak sealing step and on the outer edge side of the container main body at a temperature higher than the weak seal.
And the medical container of this invention is a medical container manufactured with the manufacturing method of the medical container of this invention.
The medical container 1 of the present invention is made of a thermoplastic resin material, and is made of a thermoplastic resin provided so as to communicate with a container body 2 having a drug chamber therein and a drug chamber 3 of the container body 2. A medical container provided with a port 12. And the container main body 2 is provided with the port attachment part 7, and the port 12 is fixed to the container main body by a fixing part formed by heat sealing in a state where one end side is inserted into the port attachment part, and The fixing portion 16 includes a weak seal portion 18 provided on the drug chamber side, and a strong seal portion 19 that is located near the weak seal portion 18 and on the outer edge side of the container body 2 and has a higher sealing strength than the weak seal portion 18. And.

最初に、本発明の医療用容器１について、図１、図２および図３を用いて説明する。
本発明の医療用容器１は、図１に示すように、容器本体２と排出ポート１２とを備えている。
容器本体としては、例えば、図４に示すようなものが使用される。この容器本体２は、熱可塑性軟質樹脂製シート２ａ，２ｂにより構成された軟質容器であり、図１，図４に示す実施例では、内部に薬液を収納可能な内部空間（薬剤室）３，４を有し、一端部及び他端部がシールされている。容器本体２の一端部には一端側シール部５が設けられ、他端部には他端側シール部６が設けられている。一端側シール部５と他端側シール部６は、幅広シール部である。また、容器本体２は、チューブ状の成形体を扁平にして得られた対向する軟質樹脂製シート２ａ，２ｂにより構成されている。
また、図４に示すように、容器本体２の一端側シール部５には、ポート取付部である排出ポート取付部７が設けられている。排出ポート取付部７は、一端側シール部５の一部をシールしないことにより容器本体２の内部空間（本発明の実施例では、第１の薬剤室３）と外部とが連通するように設けられている。排出ポート取付部７は、排出ポート１２が取り付け（配置、挿入）しやすいように、それぞれ容器本体２の内部空間３側から容器本体２の外縁に向かって拡径している。
また、この実施例では、容器本体２の内部空間は、図１，図４に示すように、剥離可能な仕切用弱シール部１０により第１の薬剤室３と第２の薬剤室４に区分されている。なお、容器本体２の内部空間は、仕切用弱シール部により仕切られない単室のものであってもよい。 Initially, the medical container 1 of this invention is demonstrated using FIG.1, FIG.2 and FIG.3.
As shown in FIG. 1, the medical container 1 of the present invention includes a container body 2 and a discharge port 12.
As the container body, for example, the one shown in FIG. 4 is used. The container body 2 is a soft container composed of thermoplastic soft resin sheets 2a and 2b. In the embodiment shown in FIGS. 1 and 4, an internal space (medicine chamber) 3, 4 and one end and the other end are sealed. One end side seal portion 5 is provided at one end portion of the container body 2, and the other end side seal portion 6 is provided at the other end portion. The one end side seal portion 5 and the other end side seal portion 6 are wide seal portions. The container body 2 is composed of opposing soft resin sheets 2a and 2b obtained by flattening a tube-shaped molded body.
Further, as shown in FIG. 4, the one end side seal portion 5 of the container body 2 is provided with a discharge port attachment portion 7 which is a port attachment portion. The discharge port mounting portion 7 is provided so that the internal space of the container body 2 (in the embodiment of the present invention, the first drug chamber 3) and the outside communicate with each other by not sealing a part of the one end side seal portion 5. It has been. The discharge port attachment portion 7 is expanded in diameter from the inner space 3 side of the container body 2 toward the outer edge of the container body 2 so that the discharge port 12 can be easily attached (arranged and inserted).
Further, in this embodiment, the internal space of the container body 2 is divided into a first drug chamber 3 and a second drug chamber 4 by a detachable partition weak seal 10 as shown in FIGS. Has been. The internal space of the container body 2 may be a single chamber that is not partitioned by the partition weak seal portion.

容器本体２は、熱可塑性軟質合成樹脂により作製されている。容器本体２は、インフレーション成形法により筒状に成形されたものが好ましい。なお、容器本体２は、例えば、Ｔダイ法、ブロー成形法、ドライラミネート法、ホットメルトラミネート法、共押出インフレーション法、共押出Ｔダイ法、ホットプレス法等の種々の方法により製造されたものでもよい。そして、容器本体２は、製造過程において扁平に折り曲げられることにより２つの側辺が形成される。また、必要により軽くプレスすることにより、折り曲げられた側辺を形成してもよい。
また、容器本体２は、水蒸気バリヤー性を有することが好ましい。水蒸気バリヤー性の程度としては、水蒸気透過度が、５０ｇ／ｍ2・２４ｈｒｓ・４０℃・９０％ＲＨ以下であることが好ましく、より好ましくは１０ｇ／ｍ2・２４ｈｒｓ・４０℃・９０％ＲＨ以下であり、さらに好ましくは１ｇ／ｍ2・２４ｈｒｓ・４０℃・９０％ＲＨ以下である。この水蒸気透過度は、ＪＩＳＫ７１２９（Ａ法）に記載の方法により測定される。
このように容器本体２が水蒸気バリヤー性を有することにより、医療用容器１の内部からの水分の蒸散が防止できる。その結果、充填される液体の減少、濃縮を防止することができる。このような容器本体２の形成材料としては、例えば、ポリエチレン（ＰＥ）、ポリプロピレン（ＰＰ）、ポリブタジエン、エチレン−酢酸ビニル共重合体（ＥＶＡ）のようなポリオレフィン、オレフィン系エラストマー、スチレン系エラストマー等の各種熱可塑性エラストマーあるいはこれらを任意に組み合わせたもの（ブレンド樹脂、ポリマーアロイ、積層体等）が挙げられる。そして、使用する樹脂材料は、高い透明性、適度な柔軟性、高圧蒸気滅菌（オートクレーブ滅菌）に耐えられる耐熱性、耐水性を有していることが好ましい。容器本体２としては、ヒートシールされる部分の内面が熱可塑性合成樹脂により作製されたものが用いられる。特に、容器本体２としては、内面全体もしくはバッグ全体が熱可塑性合成樹脂で作製されたものが好ましい。 The container body 2 is made of a thermoplastic soft synthetic resin. The container body 2 is preferably formed into a cylindrical shape by an inflation molding method. The container body 2 is manufactured by various methods such as a T-die method, a blow molding method, a dry laminating method, a hot melt laminating method, a coextrusion inflation method, a coextrusion T die method, and a hot press method. But you can. And the container main body 2 is formed into two sides by being bent flat in the manufacturing process. Moreover, you may form the bent side by lightly pressing as needed.
The container body 2 preferably has a water vapor barrier property. As the degree of water vapor barrier property, the water vapor permeability is preferably 50 g / m 2 · 24 hrs · 40 ° C. · 90% RH or less, more preferably 10 g / m 2 · 24 hrs · 40 ° C. · 90% RH or less. More preferably, it is 1 g / m 2 · 24 hrs · 40 ° C. · 90% RH or less. This water vapor permeability is measured by the method described in JISK7129 (Method A).
Thus, the container main body 2 has a water vapor barrier property, so that evaporation of moisture from the inside of the medical container 1 can be prevented. As a result, it is possible to prevent a decrease in liquid filling and concentration. Examples of the material for forming the container body 2 include polyethylene (PE), polypropylene (PP), polybutadiene, polyolefins such as ethylene-vinyl acetate copolymer (EVA), olefin elastomers, and styrene elastomers. Various thermoplastic elastomers or those arbitrarily combined (blend resin, polymer alloy, laminate, etc.) can be mentioned. The resin material to be used preferably has high transparency, moderate flexibility, heat resistance and water resistance that can withstand high-pressure steam sterilization (autoclave sterilization). As the container main body 2, one in which the inner surface of the portion to be heat sealed is made of a thermoplastic synthetic resin is used. In particular, the container body 2 is preferably one in which the entire inner surface or the entire bag is made of a thermoplastic synthetic resin.

また、容器本体２の形成材料として、ポリオレフィンが含有されるとき、本発明の有用性が大きいものとなる。したがって、本発明においては、容器本体２の形成材料として、ポリオレフィンを含むものであるのが好ましい。容器本体２の形成材料として、特に好ましいものとして、ポリエチレンまたはポリプロピレンに、スチレン−ブタジエン共重合体やスチレン−エチレン−ブチレン−スチレンブロック共重合体等のスチレン系熱可塑性エラストマーあるいはオレフィン系熱可塑性エラストマーをブレンドし柔軟化した軟質樹脂を挙げることができる。この材料は、高強度で柔軟性に富み、耐熱性（特に滅菌時の耐熱性）、耐水性が高い他、加工性が特に優れ、また、軟質バッグは、前述したような材料よりなる単層構造のもの（単層体）であってもよいし、また種々の目的で、複数の層（特に異種材料の層）を重ねた多層積層体であってもよい。多層積層体の場合、複数の樹脂層を重ねたものであってもよいし、少なくとも１層の樹脂層に金属層を積層したものであってもよい。複数の樹脂層を重ねたものの場合、それぞれの樹脂の利点を併有することができ、例えば、容器本体２の耐衝撃性を向上させたり、対ブロッキング性を付与したりすることができる。また、金属層を有するものの場合、容器本体２のガスバリヤー性等を向上させることができる。例えば、アルミ箔等のフィルムが積層された場合、ガスバリヤー性の向上とともに、遮光性を付与することができる。また、酸化チタン、酸化アルミニウム、酸化ケイ素等の酸化物からなる層を形成した場合、ガスバリヤー性の向上とともに、シート状筒状体２の透明性を維持することができ、内部の視認性を確保することができる。なお、容器本体２が多層積層体である場合、その内表面部分を形成する材料が、前述した材料であるのが好ましい。   Moreover, when polyolefin is contained as a forming material of the container body 2, the usefulness of the present invention is great. Therefore, in this invention, it is preferable that polyolefin is included as a forming material of the container main body 2. As a material for forming the container body 2, as a particularly preferable material, a styrene-based thermoplastic elastomer or olefin-based thermoplastic elastomer such as styrene-butadiene copolymer or styrene-ethylene-butylene-styrene block copolymer is added to polyethylene or polypropylene. Mention may be made of soft resins blended and softened. This material has high strength and flexibility, heat resistance (especially heat resistance during sterilization), high water resistance, and particularly excellent processability. The soft bag is a single layer made of the above-mentioned materials. It may be a structure (single layer), or may be a multilayer laminate in which a plurality of layers (particularly layers of different materials) are stacked for various purposes. In the case of a multilayer laminate, a plurality of resin layers may be stacked, or a metal layer may be stacked on at least one resin layer. In the case where a plurality of resin layers are stacked, the advantages of the respective resins can be provided together. For example, the impact resistance of the container body 2 can be improved or anti-blocking properties can be imparted. Further, in the case of a metal layer, the gas barrier property of the container body 2 can be improved. For example, when a film such as an aluminum foil is laminated, the light barrier property can be imparted with the improvement of the gas barrier property. In addition, when a layer made of an oxide such as titanium oxide, aluminum oxide, or silicon oxide is formed, the gas barrier property can be improved and the transparency of the sheet-like cylindrical body 2 can be maintained. Can be secured. In addition, when the container main body 2 is a multilayer laminated body, it is preferable that the material which forms the inner surface part is the material mentioned above.

容器本体２を構成するシート（単層または多層積層体）２ａ，２ｂの厚さは、その層構成や用いる素材の特性（柔軟性、強度、水蒸気透過性、耐熱性等）等に応じて適宜決定され、特に限定されるものではないが、通常は、１００〜５００μｍ程度であるのが好ましく、２００〜３００μｍ程度であるのがより好ましい。
また、医療用容器１の容積は、内部に収納する液体の種類等によって異なるが、通常は、５０〜５０００ｍｌ程度であるのが好ましく、１００〜３０００ｍｌ程度であるのがより好ましい。
容器本体２の一端側シール部５及び他端側シール部６は、熱融着（ヒートシール）、高周波融着等により形成されることが好ましく、特に、熱融着により行うことが好ましい。 The thickness of the sheets (single layer or multilayer laminate) 2a, 2b constituting the container body 2 is appropriately determined depending on the layer configuration and the characteristics of the material used (flexibility, strength, water vapor permeability, heat resistance, etc.) Although it is determined and is not particularly limited, it is usually preferably about 100 to 500 μm, more preferably about 200 to 300 μm.
Moreover, although the volume of the medical container 1 changes with kinds etc. of the liquid accommodated in an inside, it is preferable normally that it is about 50-5000 ml, and it is more preferable that it is about 100-3000 ml.
The one end side seal portion 5 and the other end side seal portion 6 of the container body 2 are preferably formed by heat fusion (heat sealing), high frequency fusion, or the like, and particularly preferably by heat fusion.

仕切用弱シール部１０は、図１，図４に示すように、容器本体２の中央付近に形成された帯状のシール部である。仕切用弱シール部１０は、第１の薬剤室３と第２の薬剤室４に液体が充填された状態の医療用容器１のいずれか一方の室を掌等で押圧したり絞るように握ったりすること等により、剥離可能な程度のシール強度を備える。また、仕切用弱シール部の両端部には、実質的に剥離しない強シール部１０ａが形成されている。このように仕切用弱シール部１０により容器本体２内を区分することにより、反応等による変質、劣化を生じる物質を含有する液体を使用するまでは別々に保存でき、使用に際し、両液を混合することが好ましいとき等に適用することができる。このような液体としては、例えば、アミノ酸電解質液とブドウ糖液、ブドウ糖液と重曹液等の組み合わせが挙げられる。また、上記のような仕切用弱シール部を備えない場合には、どのような液体を充填してもよく、例えば、生理食塩水、電解質溶液、リンゲル液、高カロリー輸液、ブドウ糖液、注射用水、腹膜透析液、経口（腸）栄養剤等が挙げられる。なお、容器本体２（医療用容器１）は、仕切用弱シール部を備えるものに限定されずに、単室構造のものであってもよい。   The partition weak seal portion 10 is a belt-like seal portion formed near the center of the container body 2 as shown in FIGS. The partition weak seal portion 10 holds the first drug chamber 3 and the second drug chamber 4 so as to press or squeeze one of the chambers of the medical container 1 filled with liquid with a palm or the like. The seal strength is such that it can be peeled off. Moreover, the strong seal part 10a which does not peel substantially is formed in the both ends of the weak seal part for a partition. By separating the inside of the container main body 2 by the partition weak seal portion 10 in this way, it can be stored separately until a liquid containing a substance that causes alteration or deterioration due to reaction or the like is used, and both liquids are mixed in use. It can be applied when it is preferable to do so. Examples of such a liquid include a combination of an amino acid electrolyte solution and a glucose solution, a glucose solution and a sodium bicarbonate solution, and the like. Further, in the case where the weak seal part for partition as described above is not provided, any liquid may be filled, for example, physiological saline, electrolyte solution, Ringer's solution, high calorie infusion solution, glucose solution, water for injection, Examples include peritoneal dialysis fluid and oral (intestinal) nutrients. In addition, the container main body 2 (medical container 1) is not limited to the one provided with the partition weak seal portion, and may be a single chamber structure.

また、容器本体２の他端側シール部６には、ハンガー等に吊り下げるための孔（吊り下げ部）９が設けられていることが好ましい。
容器本体２に取り付けられるポートとしては、排出ポート及び／若しくは混注ポートであることが好ましい。本発明の実施例では容器本体２の下端部に排出ポート１２が取り付けられている。また、上端部に混注ポート（図示せず）を取り付けてもよい。
また、本発明で使用される排出ポート１２としては公知のものを使用することが好ましく、例えば、筒状ポート部材とその開口を封止するとともに針管を挿通可能なシール部材を備えるものが好ましい。具体的に、排出ポート１２としては、両端側が開口した筒状ポート部材１３と、筒状ポート部材１３の容器本体２内に侵入していない端部の開口部を封止するシール部材１５を有する蓋部材１４とからなるものであることが好ましい。 Moreover, it is preferable that the other end side seal portion 6 of the container body 2 is provided with a hole (hanging portion) 9 for hanging on a hanger or the like.
The port attached to the container body 2 is preferably a discharge port and / or a mixed injection port. In the embodiment of the present invention, the discharge port 12 is attached to the lower end of the container body 2. Moreover, you may attach a mixed injection port (not shown) to an upper end part.
Moreover, it is preferable to use a well-known thing as the discharge port 12 used by this invention, For example, what is equipped with the sealing member which can insert a needle tube while sealing the cylindrical port member and its opening is preferable. Specifically, the discharge port 12 includes a cylindrical port member 13 that is open at both ends, and a seal member 15 that seals the opening of the cylindrical port member 13 that does not enter the container body 2. The lid member 14 is preferably used.

また、シール部材１５は、自己閉塞性を有し、針管を弾性体から抜き取った後は、その穿刺孔が閉塞し、薬液の漏れを防止するものであることが好ましい。シール材の構成材料としては、例えば、オレフィン系エラストマー、スチレン系エラストマー、ポリアミドエラストマー、ポリエステルエラストマー等の熱可塑性樹脂（熱可塑性エラストマー）、天然ゴム、イソプレンゴム、シリコーンゴム、ブタジエンゴム、スチレン−ブタジエンゴムのような各種ゴム材料等の弾性材料、あるいはこれらのうちの任意の２以上を組み合わせたものが挙げられ、シール性、再シール性の点からは弾性材料を含有しているものが好ましい。また、ポートとしては、円筒状、楕円筒状あるいは多角柱状の成形品であることが好ましい。   Moreover, it is preferable that the sealing member 15 has a self-occlusion property, and after the needle tube is extracted from the elastic body, the puncture hole is closed to prevent leakage of the chemical solution. Examples of the constituent material of the sealing material include thermoplastic resins (thermoplastic elastomer) such as olefin elastomer, styrene elastomer, polyamide elastomer, and polyester elastomer, natural rubber, isoprene rubber, silicone rubber, butadiene rubber, and styrene-butadiene rubber. The elastic materials such as various rubber materials, or a combination of any two or more of these materials can be used, and those containing an elastic material are preferable in terms of sealing properties and resealing properties. The port is preferably a cylindrical, elliptical cylindrical or polygonal column shaped product.

混注ポートとしては、公知のものを使用することが好ましく、例えば、筒状ポート部材とその開口を封止するとともに針管を挿通可能なシール部材を備えるものが好ましい。混注ポートにおけるシール部材の構成材料は排出ポートのシール部材と同様のものが用いられる。また、混注ポート取付部も容器本体２の一端側シール部もしくは他端側シール部の一部をシールしないことにより形成することが好ましい。
排出ポート１２、混注ポートの構成材料としては、容器本体２と相溶性を有する樹脂であることが好ましい。また、排出用、混注用穿刺針の刺通操作を良好にするため、硬質材料であることが好ましい。例えば、硬質ポリ塩化ビニル、ポリエチレン、ポリプロピレン、ポリブタジエン、環状ポリオレフィン（具体的には、ＺＥＯＮＥＸ（登録商標、日本ゼオン株式会社）、ＡＰＥＬ（登録商標、三井化学株式会社製））、ポリプロピレン、ポリプロピレンホモポリマー、高密度ポリエチレンのようなポリオレフィン、ポリスチレン、ポリ−（４−メチルペンテン−１）、ポリカーボネート、ＡＢＳ樹脂、アクリル樹脂、ポリメチルメタクリレート（ＰＭＭＡ）、ポリアセタール、ポリアリレート、ポリアクリロニトリル、ポリフッ化ビニリデン、アイオノマー、アクリロニトリル−ブタジエン−スチレン共重合体、ポリエチレンテレフタレート（ＰＥＴ）、ポリブチレンテレフタレート（ＰＢＴ）のようなポリエステル、ブタジエン−スチレン共重合体、芳香族または脂肪族ポリアミド等の各種樹脂、あるいはこれらを任意に混合あるいは積層して組み合わせたものが挙げられる。 It is preferable to use a well-known port as the co-injection port. For example, it is preferable to provide a cylindrical port member and a seal member that seals the opening and allows the needle tube to be inserted. As the constituent material of the seal member in the mixed injection port, the same material as the seal member of the discharge port is used. Also, the mixed injection port mounting portion is preferably formed by not sealing one end side seal portion or the other end side seal portion of the container body 2.
The constituent material of the discharge port 12 and the mixed injection port is preferably a resin having compatibility with the container body 2. Moreover, in order to improve the piercing operation of the puncture needle for discharging and mixed injection, a hard material is preferable. For example, rigid polyvinyl chloride, polyethylene, polypropylene, polybutadiene, cyclic polyolefin (specifically, ZEONEX (registered trademark, Nippon Zeon Co., Ltd.), APEL (registered trademark, manufactured by Mitsui Chemicals)), polypropylene, polypropylene homopolymer , Polyolefin such as high density polyethylene, polystyrene, poly- (4-methylpentene-1), polycarbonate, ABS resin, acrylic resin, polymethyl methacrylate (PMMA), polyacetal, polyarylate, polyacrylonitrile, polyvinylidene fluoride, ionomer , Acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), butadiene-styrene Polymer, various resins such as aromatic or aliphatic polyamide, or those to which they were combined arbitrarily mixed or laminated thereof.

そして、図１ないし図３に説明するように、熱可塑性樹脂製ポート１２（具体的には、排出ポート１２の筒状ポート部材１３）は、一端側が容器本体２のポート取付部７内に挿入された状態にて、ヒートシールにより形成された固定部１６により容器本体２に固定されている。
そして、ポートを容器本体に固定する固定部１６は、薬剤室側に設けられた弱シール部１８と、弱シール部１８に近接しかつ容器本体２の外縁側に位置し、かつ弱シール部１８よりシール強度が高い強シール部１９とを備えている。
本発明では、ポートを容器本体に固定する固定部１６は、容器本体２の外縁部に位置する強シール部のみならず、ポートの容器本体内に侵入した端部側を弱シールする弱シール部を備えている。
弱シール部のシール強度（初期の剥離強度）は、１〜２５Ｎ／１０ｍｍ、特に、２〜２０Ｎ／１０ｍｍであることが好ましい。また、上記のように固定部が排出ポートを固定するものである場合、弱シール部１８は、医療用容器の吊り下げ時における薬剤室内の薬液による加重では剥離しないものであることが好ましい。このようにすることにより、ポート端部における薬剤の残液を防止できる。
また、強シール部のシール強度（初期の剥離強度）は、１０〜５０Ｎ／１０ｍｍ、特に、２０〜４０Ｎ／１０ｍｍであることが好ましい。また、弱シール部１８と高い強シール部１９とのシール強度差（初期の剥離強度差）は、強シール部が、弱シール部のシール強度（初期の剥離強度）より、５〜３０Ｎ／１０ｍｍ、特に、１０〜２５Ｎ／１０ｍｍ大きいものであることが好ましい。 As shown in FIGS. 1 to 3, the thermoplastic resin port 12 (specifically, the cylindrical port member 13 of the discharge port 12) is inserted into the port mounting portion 7 of the container body 2 at one end side. In this state, the container body 2 is fixed by a fixing portion 16 formed by heat sealing.
And the fixing | fixed part 16 which fixes a port to a container main body is located in the outer edge side of the container main body 2 near the weak seal part 18 provided in the chemical | medical agent chamber side, the weak seal part 18, and the weak seal part 18 And a strong seal portion 19 having higher seal strength.
In the present invention, the fixing portion 16 for fixing the port to the container body is not only a strong seal portion located at the outer edge of the container body 2 but also a weak seal portion that weakly seals the end side of the port that has entered the container body. It has.
The seal strength (initial peel strength) of the weak seal portion is preferably 1 to 25 N / 10 mm, and particularly preferably 2 to 20 N / 10 mm. Moreover, when the fixing part fixes the discharge port as described above, it is preferable that the weak seal part 18 is not peeled off by the load of the chemical solution in the medicine chamber when the medical container is suspended. By doing in this way, the residual liquid of the chemical | medical agent in a port edge part can be prevented.
Further, the seal strength (initial peel strength) of the strong seal portion is preferably 10 to 50 N / 10 mm, and particularly preferably 20 to 40 N / 10 mm. Further, the seal strength difference (initial peel strength difference) between the weak seal portion 18 and the high strong seal portion 19 is 5-30 N / 10 mm in the strong seal portion from the seal strength (initial peel strength) of the weak seal portion. In particular, it is preferably 10 to 25 N / 10 mm larger.

そして、この実施例の医療用容器１では、図１および図３に示すように、弱シール部１８は、ポートの端部（具体的には、筒状ポート部材１３の端部）を容器本体２に弱シールする中央弱シール部１８ａと、中央弱シール部１８ａの両端より、容器本体２の薬剤室の内縁方向に延び、かつ前記容器本体の薬剤室の内縁に到達する側部弱シール部とを備えている。特に、この実施例の医療用容器１では、側部弱シール部は、中央弱シール部１８ａの両端より、容器本体２の上端方向かつ側部方向に延びる傾斜側部弱シール部１８ｂとなっている。さらに、この実施例の医療用容器２では、傾斜側部弱シール部１８ｂの端部より、容器本体の側部方向に延びる側部弱シール部端部１８ｃを備えている。このように、中央部が窪んだ形状とすることにより、ポートの端部付近に確実に弱シール部を形成可能であるとともに、その状態の保持も可能となる。また、この実施例の医療用容器では、中央弱シール部１８ａと側部弱シール部端部１８ｃは、ほぼ平行で所定長延びるものとなっており、傾斜側部弱シール部１８ｂがそれらを接続する状態となっている。弱シール部の太さ（幅）、具体的には、中央弱シール部１８ａ、傾斜側部弱シール部１８ｂおよび側部弱シール部端部１８ｃの太さ（幅）は、
３〜２０ｍｍ程度が好ましい。
そして、この実施例の医療用容器１では、図１および図３に示すように、強シール部１９は、ポート（具体的には、筒状ポート部材１３）を容器本体に強シールする中央強シール部１９ａと、中央強シール部１９ａの両端より、容器本体２の上端方向かつ側部方向に延びる傾斜側部強シール部１９ｂを備えている。さらに、この実施例の医療用容器１では、傾斜側部強シール部１９ｂの端部より、容器本体の側部方向に延びる側部強シール部端部１９ｃを備えている。強シール部１９の形状をこのようにすることにより、ポート（具体的には、筒状ポート部材１３）を容器本体に確実に固着できる。 In the medical container 1 of this embodiment, as shown in FIGS. 1 and 3, the weak seal portion 18 has the end of the port (specifically, the end of the cylindrical port member 13) at the container body. A weak central seal portion 18a that is weakly sealed to 2 and side weak seal portions that extend from both ends of the central weak seal portion 18a toward the inner edge of the drug chamber of the container body 2 and reach the inner edge of the drug chamber of the container body. And. In particular, in the medical container 1 of this embodiment, the side weak seal portions are inclined side weak seal portions 18b extending from both ends of the central weak seal portion 18a toward the upper end direction and the side direction of the container main body 2. Yes. Furthermore, the medical container 2 of this embodiment is provided with a side weak seal portion end portion 18c extending from the end portion of the inclined side weak seal portion 18b in the side portion direction of the container body. Thus, by making the center part into a depressed shape, it is possible to reliably form the weak seal part near the end part of the port, and it is possible to hold the state. In the medical container of this embodiment, the central weak seal portion 18a and the side weak seal portion end portion 18c are substantially parallel and extend for a predetermined length, and the inclined side weak seal portion 18b connects them. It is in a state to do. The thickness (width) of the weak seal portion, specifically, the thickness (width) of the central weak seal portion 18a, the inclined side weak seal portion 18b and the side weak seal portion end portion 18c,
About 3-20 mm is preferable.
In the medical container 1 of this embodiment, as shown in FIGS. 1 and 3, the strong seal portion 19 has a central strength that strongly seals the port (specifically, the cylindrical port member 13) to the container body. An inclined side portion strong seal portion 19b extending in the upper end direction and the side portion direction of the container body 2 from both ends of the seal portion 19a and the central strong seal portion 19a is provided. Furthermore, the medical container 1 of this embodiment includes a side strong seal portion end 19c extending in the side direction of the container body from the end of the inclined side strong seal portion 19b. By making the shape of the strong seal portion 19 in this way, the port (specifically, the cylindrical port member 13) can be reliably fixed to the container body.

次に、本発明の実施例である医療用容器の製造方法について添付図面を用いて説明する。
本発明の医療用容器の製造方法は、図１３に示すように、ポート取付部７を有する熱可塑性樹脂製材料により構成された軟質容器本体２を準備する工程と、熱可塑性樹脂製ポート１２を準備する工程と、ポート１２の一端側を容器本体２のポート取付部７に挿入するポート挿入工程と、ポート挿入工程により挿入されたポート１２の端部を容器本体２にヒートシールにより弱シールする弱シール工程と、ポート挿入工程により挿入されたポートの弱シール工程による弱シールされる部分に近接しかつ容器本体の外縁側となる部分を弱シールより高い温度にて容器本体にヒートシールする強シール工程とを備える。そして、本発明の医療用容器の製造方法は、図５に示すように、ポート挿入工程の後、ポートより前記容器本体内の空気を吸引する吸引工程を行うものであることが好ましい。 Next, the manufacturing method of the medical container which is an Example of this invention is demonstrated using an accompanying drawing.
As shown in FIG. 13, the method for manufacturing a medical container of the present invention includes a step of preparing a flexible container body 2 made of a thermoplastic resin material having a port mounting portion 7, and a thermoplastic resin port 12. A step of preparing, a port insertion step of inserting one end side of the port 12 into the port mounting portion 7 of the container body 2, and an end of the port 12 inserted in the port insertion step is weakly sealed to the container body 2 by heat sealing. Strongly heat-seal the container body at a higher temperature than the weak seal, close to the weakly sealed part of the weakly sealed process and the weakly sealed process of the port inserted by the port inserting process. A sealing step. And as shown in FIG. 5, it is preferable that the manufacturing method of the medical container of this invention performs the attraction | suction process which attracts | sucks the air in the said container main body from a port after a port insertion process.

最初に、軟質容器本体の準備工程および熱可塑性樹脂製ポートの準備工程について説明する。
軟質容器本体としては、上述したものが準備される。また、ポートとしても上述したものが準備される。
また、準備される容器本体２としては、一端側シール部５に、第１の薬剤室３に収納される薬液を注入するための注入孔（図示せず）を有するものであってもよい。注入孔は、容器本体２の一端側シール部５の一部分をシールしないことにより容器本体２の内部空間と外部とが連通するように形成されることが好ましい。また、容器本体２の他端側シール部６には、第２の薬剤室４に収納される薬液を注入するための注入孔（図示せず）が形成されていてもよい。注入孔は、容器本体２の他端側シール部６の一部分をシールしないことにより内部空間（第２の薬剤室４）と外部とが連通するように形成されることが好ましい。注入孔は、第１の薬剤室３もしくは第２の薬剤室４に薬液を注入後シールされる。また、薬液の注入は、ポート１２を構成する筒状ポート部材１３を介して注入してもよい。
容器本体２の一端側シール部５及び他端側シール部６は、熱融着（ヒートシール）、高周波融着等により形成されることが好ましく、特に、熱融着により行うことが好ましい。 First, the preparation process of the soft container body and the preparation process of the thermoplastic resin port will be described.
As the soft container body, the above-described one is prepared. In addition, the ports described above are prepared.
Moreover, as the container main body 2 prepared, you may have the injection hole (not shown) for inject | pouring the chemical | medical solution accommodated in the 1st chemical | medical agent chamber 3 in the one end side seal part 5. FIG. The injection hole is preferably formed so that the internal space of the container body 2 communicates with the outside by not sealing a part of the one end side seal portion 5 of the container body 2. Further, the other end side seal portion 6 of the container body 2 may be formed with an injection hole (not shown) for injecting a chemical solution stored in the second drug chamber 4. The injection hole is preferably formed so that the internal space (second drug chamber 4) and the outside communicate with each other by not sealing a part of the seal portion 6 on the other end side of the container body 2. The injection hole is sealed after the drug solution is injected into the first drug chamber 3 or the second drug chamber 4. Further, the chemical solution may be injected through a cylindrical port member 13 constituting the port 12.
The one end side seal portion 5 and the other end side seal portion 6 of the container body 2 are preferably formed by heat fusion (heat sealing), high frequency fusion, or the like, and particularly preferably by heat fusion.

次に、ポートの一端側を容器本体のポート取付部に挿入するポート挿入工程について図５、図７、図１３を用いて説明する。
ポート挿入工程は、図７、図１３に示すように、排出ポートの主構成物である筒状ポート部材１３を容器本体２の一端側シール部５に設けられた排出ポート取付部７に挿入することにより行われる。
図７に示すように、排出ポートの筒状ポート部材１３を配置しただけの状態では、ポート取付部７を構成する上端側のシート２ａと下端側のシート２ｂのうち筒状ポート部材１３と近接する部分は離間している。また、この状態において筒状ポート部材とポート取付部でのシート２ａ、２ｂとの間はシール時にシートのたるみによるしわが生じないように、また、後述する吸引工程が良好に行なえるように、ポート取付部７を構成するシートの筒状ポート部材１３と近接する部分には、ある程度テンションがかかっている。この状態で、シール用金型を用いてヒートシールすると、シール用金型の押圧に対するシート２ａとシート２ｂの反発により、ポート取付部７を構成するシート２ａ，２ｂのうち、筒状ポート部材１３の外周面上もしくは両側に位置する部分の一部が極端にが肉薄になり易くなる。
なお、本発明の実施例では、組み立てられた排出ポート１２を固定するものではなく、主構成物である筒状ポート部材１３を排出ポート取付部７に挿入している。そして、ヒートシール工程により、筒状ポート部材１３を容器本体２に固定した後、蓋部材１４を筒状ポート部材１３に取り付けることにより、排出ポートを組み立てるものとしている。このようにすることにより、蓋部材１４を取り付ける前のポート１２を構成する筒状ポート部材１３を用いて、容器本体２内に薬液を注入および後述する容器本体内の吸引を可能としている。 Next, a port insertion process for inserting one end side of the port into the port mounting portion of the container body will be described with reference to FIGS. 5, 7, and 13.
In the port insertion step, as shown in FIGS. 7 and 13, the cylindrical port member 13, which is the main component of the discharge port, is inserted into the discharge port mounting portion 7 provided on the one end side seal portion 5 of the container body 2. Is done.
As shown in FIG. 7, in the state in which the cylindrical port member 13 of the discharge port is merely disposed, the cylindrical port member 13 is close to the upper end side sheet 2 a and the lower end side sheet 2 b constituting the port mounting portion 7. The parts to be separated are separated. Further, in this state, a wrinkle due to sheet sagging does not occur during sealing between the cylindrical port member and the sheet 2a, 2b at the port mounting portion, and a suction process described later can be performed satisfactorily. A portion of the sheet that forms the port attachment portion 7 is close to the cylindrical port member 13 in some tension. When heat sealing is performed using the sealing mold in this state, the cylindrical port member 13 out of the sheets 2a and 2b constituting the port mounting portion 7 due to the repulsion of the sheet 2a and the sheet 2b against the pressing of the sealing mold. A part of the part located on the outer peripheral surface or on both sides is likely to be extremely thin.
In addition, in the Example of this invention, the assembled discharge port 12 is not fixed, but the cylindrical port member 13 which is a main component is inserted in the discharge port attaching part 7. FIG. And after fixing the cylindrical port member 13 to the container main body 2 by a heat sealing process, the discharge port is assembled by attaching the lid member 14 to the cylindrical port member 13. By doing in this way, using the cylindrical port member 13 which comprises the port 12 before attaching the cover member 14, a chemical | medical solution can be inject | poured in the container main body 2, and the suction | inhalation in the container main body mentioned later is enabled.

そして、この実施例の医療用容器の製造方法では、図５および図８に示すように、ポート挿入工程の後、ポートより容器本体内の空気を吸引する吸引工程を行うものとなっている。
吸引工程は、図８に示すように、ポート挿入工程により配置されたポートの筒状ポート部材１３に吸引手段３１（装置は図示せず）を接続し、吸引手段３１を作動させることにより行われる。吸引手段としては、真空ポンプを用いるものなどの公知のものが使用できる。吸引工程により、容器本体内の空気が吸引され、容器本体内が減圧状態となる。これにより、容器本体２は、図７に示す状態から図８に示す状態となり、ポート取付部７を構成する上端側のシート２ａと下端側のシート２ｂのうち筒状ポート部材１３と近接する部分はかなり密着した状態となる。 And in the manufacturing method of the medical container of this Example, as shown in FIG.5 and FIG.8, the suction process which attracts | sucks the air in a container main body from a port is performed after a port insertion process.
As shown in FIG. 8, the suction process is performed by connecting the suction means 31 (device not shown) to the cylindrical port member 13 of the port arranged in the port insertion process and operating the suction means 31. . As the suction means, known means such as those using a vacuum pump can be used. By the suction process, air in the container body is sucked and the container body is in a reduced pressure state. As a result, the container main body 2 changes from the state shown in FIG. 7 to the state shown in FIG. Will be in close contact.

次に、ポート挿入工程により挿入されたポートの端部を容器本体にヒートシールにより弱シールする弱シール工程を行う。弱シール工程を図６、図９、図１４を用いて説明する。
この工程は、上述した吸引工程における吸引を維持した状態にて行うことが好ましい。
そして、この弱シール工程は、ポート挿入工程により配置されたポート（筒状ポート部材１３）の端部の外周面付近をシート外面より圧迫してポート取付部７を構成するシート２ａ，２ｂ同士を筒状ポート部材に隙間なく確実に接触させた状態で、当該部位を弱シールするものである。
本発明の製造方法における弱シール工程およびヒートシール工程にて使用されるヒートシール装置２０としては、図６に示すようなものが用いられる。
この実施例のヒートシール装置２０は、図６に示すように、弱シール金型部２２と強シール金型部２６とを備える。具体的には、ヒートシール装置２０は、筒状ポート部材１３をその一端が薬剤室３に露出するように、容器本体２に形成されたポート取付部７に挿入した状態において、筒状ポート部材１３の端部の外周面付近を容器本体２の両面側から圧迫（言い換えると、狭圧、以下同様）して筒状ポート部材１３にシート２ａ，２ｂ同士を圧接可能かつ加熱可能な弱シール金型部２２と、弱シール金型部２２よりも容器本体の外縁側の取付部にて筒状ポート部材１３を容器本体２にヒートシールにより固着するための強シール金型部２６とを備える。 Next, a weak sealing process is performed in which the end of the port inserted in the port insertion process is weakly sealed to the container body by heat sealing. The weak sealing process will be described with reference to FIGS.
This step is preferably performed in a state where the suction in the above-described suction step is maintained.
And this weak sealing process presses the outer peripheral surface vicinity of the edge part of the port (tubular port member 13) arrange | positioned by a port insertion process from a sheet | seat outer surface, and sheet | seat 2a, 2b which comprises the port attachment part 7 is made. The part is weakly sealed in a state in which the tubular port member is reliably brought into contact with no gap.
As the heat sealing device 20 used in the weak sealing step and the heat sealing step in the production method of the present invention, the one shown in FIG. 6 is used.
As shown in FIG. 6, the heat seal device 20 of this embodiment includes a weak seal mold portion 22 and a strong seal mold portion 26. Specifically, the heat seal device 20 has a cylindrical port member 13 in a state in which the cylindrical port member 13 is inserted into the port mounting portion 7 formed in the container body 2 such that one end of the cylindrical port member 13 is exposed to the drug chamber 3. 13 is a weak seal that can press and heat the sheet 2a, 2b against the cylindrical port member 13 by pressing the vicinity of the outer peripheral surface of the end portion 13 from both sides of the container body 2 (in other words, narrow pressure, the same applies hereinafter). A mold part 22 and a strong seal mold part 26 for fixing the cylindrical port member 13 to the container main body 2 by heat sealing at an attachment part on the outer edge side of the container main body with respect to the weak seal mold part 22 are provided.

この実施例のヒートシール装置２０の弱シール金型部２２は、容器本体２の一方の面側及び他方の面側からポート１２（筒状ポート部材１３）の外周面付近の薬剤室側に位置する部分（端部）を押圧し、ポート１２（筒状ポート部材１３）を構成するシート２ａ，２ｂ同士を圧接させた状態にて弱シールさせるためのものである。本発明の実施例においては、弱シール金型部２２は、ポート１２（筒状ポート部材１３）の外周面部分及びポート１２（筒状ポート部材１３）の両側部分を圧迫するものとなっている。
また、弱シール金型部２２は、第１の弱シール金型部（上部側弱シール金型部）２３と第２の弱シール金型部（下部側弱シール金型部）２４とにより構成されている。
上部側弱シール金型部２３は、図６に示すように、ポート１２（筒状ポート部材１３）の外面形状に対応した表面形状を備える中央弱シール部形成部２３ａと、中央弱シール部形成部２３ａの両側に平面状に形成された側部弱シール部形成部とを有する。また、この実施例の金型では、側部弱シール部形成部は、傾斜側部弱シール形成部２３ｂと、傾斜側部弱シール形成部２３ｂの端部より、側部方向に延びる側部弱シール端部形成部２３ｃとを備えるものとなっている。
同様に、下部側弱シール金型部２４は、図６に示すように、ポート１２（筒状ポート部材１３）の外面形状に対応した表面形状を備える中央弱シール部形成部２４ａと、中央弱シール部形成部２４ａの両側に平面状に形成された側部弱シール部形成部とを有する。また、この実施例の金型では、側部弱シール部形成部は、傾斜側部弱シール形成部２４ｂと、傾斜側部弱シール形成部２４ｂの端部より、側部方向に延びる側部弱シール端部形成部２４ｃとを備えるものとなっている。 The weak seal mold portion 22 of the heat seal device 20 of this embodiment is located on the drug chamber side near the outer peripheral surface of the port 12 (tubular port member 13) from the one surface side and the other surface side of the container body 2. This is to weakly seal the sheet 2a, 2b constituting the port 12 (cylindrical port member 13) by pressing the portion (end) to be pressed. In the embodiment of the present invention, the weak seal mold portion 22 compresses the outer peripheral surface portion of the port 12 (cylindrical port member 13) and both side portions of the port 12 (cylindrical port member 13). .
Further, the weak seal mold part 22 includes a first weak seal mold part (upper side weak seal mold part) 23 and a second weak seal mold part (lower side weak seal mold part) 24. Has been.
As shown in FIG. 6, the upper-side weak seal mold portion 23 includes a central weak seal portion forming portion 23a having a surface shape corresponding to the outer surface shape of the port 12 (cylindrical port member 13), and a central weak seal portion forming portion. It has the side part weak seal part formation part formed in planar shape on both sides of the part 23a. Moreover, in the metal mold | die of this Example, a side part weak seal part formation part is a side weak part extended in a side part direction from the edge part of the inclination side part weak seal formation part 23b and the inclination side part weak seal formation part 23b. The seal end portion forming portion 23c is provided.
Similarly, as shown in FIG. 6, the lower-side weak seal mold portion 24 includes a central weak seal portion forming portion 24a having a surface shape corresponding to the outer surface shape of the port 12 (tubular port member 13), and a central weak seal portion. A side weak seal portion forming portion formed in a planar shape is provided on both sides of the seal portion forming portion 24a. Moreover, in the metal mold | die of this Example, the side part weak seal part formation part is the side part weak extension extended in a side part direction from the edge part of the inclination side part weak seal formation part 24b and the inclination side part weak seal formation part 24b. The seal end portion forming portion 24c is provided.

上述したヒートシール装置２０の弱シール金型部２２を用いて弱シールすることにより、 図１４に示すように、排出ポート１２（筒状ポート部材１３）が容器本体２のポート取付部７に固定される。上述した弱シール金型部２２によるヒートシールにより、図３に示す上述した形態の弱シール部１８が形成される。
そして、図９に示すように、上記のヒートシール装置２０の弱シール金型部２２を用いて、ポート１２（筒状ポート部材１３）の端部を容器本体２に弱シールする。弱シールする際の弱シール金型部２２の温度は、容器本体２の形成材料の溶融温度より０〜２０℃高いものとして行うことが好ましく、特に、５〜１５℃高いものとすることが好ましい。また、容器本体２が積層体により形成されている場合には、内側層を形成する形成材料の溶融温度より０〜２０℃高いものとして行うことが好ましく、特に、５〜１５℃高いものとすることが好ましい。また、弱シール工程におけるシール圧は、容器本体２の形成材料等によっても相違するが、２〜２０ｋｇ／ｃｍ2であるのが好ましく、５〜１５ｋｇ／ｃｍ2であることがより好ましい。
また、上述した吸引工程は、少なくとも弱シール工程開始時まで行うものであることが好ましい。特に、図５に示すように、吸引工程は、弱シール工程開始時まで継続していることが好ましい。 As shown in FIG. 14, the discharge port 12 (cylindrical port member 13) is fixed to the port mounting portion 7 of the container body 2 by performing weak sealing using the weak sealing mold portion 22 of the heat sealing device 20 described above. Is done. By the above-described heat sealing by the weak seal mold portion 22, the weak seal portion 18 having the above-described configuration shown in FIG. 3 is formed.
Then, as shown in FIG. 9, the end of the port 12 (cylindrical port member 13) is weakly sealed to the container body 2 using the weak seal mold portion 22 of the heat seal device 20. It is preferable that the temperature of the weak sealing mold portion 22 when performing weak sealing is 0 to 20 ° C. higher than the melting temperature of the forming material of the container body 2, and particularly preferably 5 to 15 ° C. higher. . Moreover, when the container main body 2 is formed with a laminated body, it is preferable to carry out as 0-20 degreeC higher than the melting temperature of the formation material which forms an inner layer, and shall be 5-15 degreeC especially high It is preferable. Further, sealing pressure on the weak seal step is different depending forming material of the container body 2 and the like, is preferably from 2~20kg / cm 2, more preferably 5~15kg / cm 2.
Moreover, it is preferable that the suction process described above is performed at least until the start of the weak sealing process. In particular, as shown in FIG. 5, the suction process is preferably continued until the start of the weak sealing process.

更に本発明の医療用容器の製造方法は、ポート挿入工程により挿入されたポートの弱シール工程による弱シールされる部分に近接しかつ容器本体の外縁側となる部分を弱シールより高い温度にて容器本体にヒートシールする強シール工程とを備える。
この実施例の製造方法では、図５に示すように、弱シール工程継続中（弱シール作業継続中）に行うことが好ましい。この実施例の製造方法では、強シール工程は、弱シール工程の開始後に開始され、かつ弱シール工程終了前に終了するものとなっている。また、上述した吸引工程は、少なくとも強シール工程開始時まで行うものであることが好ましい。特に、図５に示すように、吸引工程は、強シール工程終了時まで継続していることが好ましい。 Furthermore, in the method for manufacturing a medical container according to the present invention, the portion that is close to the weakly sealed portion of the port inserted by the port inserting step and that is on the outer edge side of the container body is at a higher temperature than the weak seal. And a strong sealing step for heat-sealing the container body.
In the manufacturing method of this embodiment, as shown in FIG. 5, it is preferable that the weak sealing process is continued (while the weak sealing operation is continued). In the manufacturing method of this embodiment, the strong sealing step is started after the start of the weak sealing step and is ended before the end of the weak sealing step. Moreover, it is preferable that the suction process described above is performed at least until the start of the strong sealing process. In particular, as shown in FIG. 5, the suction process is preferably continued until the end of the strong sealing process.

強シール工程は、上述したヒートシール装置２０の強シール金型部２６を用いて行われる。
強シール金型部２６は、図６に示すように、第１の強シール金型部（上部側強シール金型部）２８と第２の強シール金型部（下部側強シール金型部）２９とにより構成されている。
上部側強シール金型部２８は、図６に示すように、ポート１２（筒状ポート部材１３）の外面形状に対応した表面形状を備える中央強シール部形成部２８ａと、中央強シール部形成部２８ａの両側に平面状に形成された側部強シール部形成部とを有する。また、この実施例の金型では、側部強シール部形成部は、傾斜側部強シール形成部２８ｂと、傾斜側部強シール形成部２８ｂの端部より、側部方向に延びる側部強シール端部形成部２８ｃとを備えるものとなっている。
同様に、下部側強シール金型部２９は、図６に示すように、ポート１２（筒状ポート部材１３）の外面形状に対応した表面形状を備える中央強シール部形成部２９ａと、中央強シール部形成部２９ａの両側に平面状に形成された側部強シール部形成部とを有する。また、この実施例の金型では、側部強シール部形成部は、傾斜側部強シール形成部２９ｂと、傾斜側部強シール形成部２９ｂの端部より、側部方向に延びる側部強シール端部形成部２９ｃとを備えるものとなっている。
特に、この実施例の製造方法では、図５に示すように、弱シール工程を継続中、言い換えれば、弱シール金型部２２により、ポート取付部７を構成するシート２ａ，２ｂを圧迫（狭圧）した状態において、行われるものとなっている。また、この実施例の強シール工程は、図１、図３ないし図１０に示すように、弱シールされる部分より容器本体２の周縁側に強シール部１９を形成させるものである。 The strong sealing step is performed using the strong sealing mold portion 26 of the heat sealing device 20 described above.
As shown in FIG. 6, the strong sealing mold part 26 includes a first strong sealing mold part (upper side strong sealing mold part) 28 and a second strong sealing mold part (lower side strong sealing mold part). 29).
As shown in FIG. 6, the upper-side strong seal mold portion 28 includes a central strong seal portion forming portion 28a having a surface shape corresponding to the outer surface shape of the port 12 (cylindrical port member 13), and a central strong seal portion formation. It has side part strong seal part formation part formed in the shape of a plane on both sides of part 28a. In the mold of this embodiment, the side strong seal portion forming portion includes the inclined side strong seal forming portion 28b and the side strength extending in the side direction from the end of the inclined side strong seal forming portion 28b. The seal end portion forming portion 28c is provided.
Similarly, as shown in FIG. 6, the lower strong seal mold portion 29 includes a central strong seal portion forming portion 29a having a surface shape corresponding to the outer surface shape of the port 12 (tubular port member 13), and a central strong portion. A side strong seal portion forming portion formed in a planar shape is provided on both sides of the seal portion forming portion 29a. In the mold of this embodiment, the side strong seal portion forming portion includes the inclined side strong seal forming portion 29b and the side strong portion extending in the side direction from the end of the inclined side strong seal forming portion 29b. The seal end portion forming portion 29c is provided.
In particular, in the manufacturing method of this embodiment, as shown in FIG. 5, while the weak sealing process is continued, in other words, the weak sealing mold portion 22 compresses (narrows) the sheets 2a and 2b constituting the port mounting portion 7. Pressure)). Further, in the strong sealing process of this embodiment, as shown in FIGS. 1 and 3 to 10, the strong seal portion 19 is formed on the peripheral side of the container body 2 from the weakly sealed portion.

上述したヒートシール装置２０の強シール金型部２６を用いて強シールすることにより、排出ポート１２（筒状ポート部材１３）が容器本体２のポート取付部７に液密に取り付けられる。上述した強シール金型部２６によるヒートシールにより、排出ポート１２の外周面及びその両側部分には帯状かつ両端が幅が広くなった強シール部１９が形成される。
強シールする際の強シール金型部２６の温度は、容器本体２の形成材料の溶融温度より２０℃以上高いものとして行うことが好ましく、特に、２０〜５０℃高いものとすることが好ましい。また、容器本体２が積層体により形成されている場合には、内側層を形成する形成材料の溶融温度より２０℃以上高いものとすることが好ましく、特に、２０〜５０℃高いものとすることが好ましい。また、強シール工程におけるシール圧は、容器本体２の形成材料等によっても相違するが、５〜５０ｋｇ／ｃｍ2であるのが好ましく、１０〜３０ｋｇ／ｃｍ2であることがより好ましい。 The exhaust port 12 (cylindrical port member 13) is liquid-tightly attached to the port attachment portion 7 of the container body 2 by performing strong sealing using the strong sealing mold portion 26 of the heat sealing device 20 described above. By the heat sealing by the above-described strong sealing mold portion 26, the strong sealing portion 19 having a belt-like shape and a wide width at both ends is formed on the outer peripheral surface of the discharge port 12 and both side portions thereof.
It is preferable that the temperature of the strong sealing mold portion 26 when performing strong sealing is higher than the melting temperature of the forming material of the container body 2 by 20 ° C. or more, and particularly preferably 20 to 50 ° C. higher. Moreover, when the container main body 2 is formed of a laminated body, it is preferably 20 ° C. or more higher than the melting temperature of the forming material forming the inner layer, and particularly 20 to 50 ° C. higher. Is preferred. Further, sealing pressure in strong seal step, which varies depending on the material for forming the container body 2 or the like is preferably from 5 to 50 kg / cm 2, and more preferably 10 to 30 kg / cm 2.

そして、この実施例の医療用容器の製造方法では、図５および図１１に示すように、強シール工程の後、強シールされた部分を冷却する冷却工程を行うものとなっている。
冷却工程は、図１１に示すように、強シール金型部２６を移動させて、強シールされた部分を開放し、当該部分に冷風をあてることにより行うものであることが好ましい。また、この実施例の製造方法では、図５に示すように、冷却工程は、弱シール工程継続中（弱シール作業継続中）に行うことが好ましい。具体的には、図１１に示すように、強シール金型部２６を移動され、かつ、弱シール金型部により狭圧を維持した状態で冷却工程が行われる。言い換えれば、弱シール工程は、ポート（筒状ポート部材）の弱シールされる外周面部分を容器本体の両面側から圧迫して行うものであり、冷却工程は、弱シール工程における圧迫を保持した状態で行われるものである。この実施例の製造方法では、冷却工程は、弱シール工程の開始後に開始され、かつ弱シール工程終了前に終了するものとなっている。
この実施例の医療用容器の製造方法では、強シール工程は、弱シール工程の開始後に開始され、かつ弱シール工程終了前に終了するものであり、冷却工程は、弱シール工程継続中に開始しかつ弱シール工程終了前に終了するものとなっている。
また、上述した吸引工程は、少なくとも冷却工程開始時まで行うものであることが好ましい。特に、図５に示すように、吸引工程は、冷却工程終了時まで継続していることが好ましい。
そして、冷却工程後、図５に示すように、弱シール工程（弱シール作業）を終了させ、その後、吸引工程（吸引作業）を終了することにより、ポート（筒状ポート部材）の容器本体への固定作業が完了する。
そして、筒状ポート部材１３に接続されていた吸引手段を取り外し、筒状ポート部材１３を用いて、容器本体２の薬剤室３内に薬剤を注入した後、筒状ポート部材１３に蓋部材１４を固定することにより、本発明の医療用容器が製造される。 And in the manufacturing method of the medical container of this Example, as shown in FIG.5 and FIG.11, after the strong sealing process, the cooling process which cools the strongly sealed part is performed.
As shown in FIG. 11, the cooling step is preferably performed by moving the strong seal mold part 26 to open the strongly sealed part and applying cold air to the part. Further, in the manufacturing method of this embodiment, as shown in FIG. 5, the cooling process is preferably performed while the weak sealing process is continuing (while the weak sealing work is continuing). Specifically, as shown in FIG. 11, the cooling process is performed in a state where the strong seal mold portion 26 is moved and the narrow pressure is maintained by the weak seal mold portion. In other words, the weak sealing process is performed by pressing the weakly sealed outer peripheral surface portion of the port (cylindrical port member) from both sides of the container body, and the cooling process maintains the pressure in the weak sealing process. Is done in a state. In the manufacturing method of this embodiment, the cooling process starts after the start of the weak sealing process and ends before the end of the weak sealing process.
In the medical container manufacturing method of this embodiment, the strong sealing process starts after the start of the weak sealing process and ends before the end of the weak sealing process, and the cooling process starts while the weak sealing process continues. In addition, it ends before the end of the weak sealing process.
Moreover, it is preferable that the suction process described above is performed at least until the start of the cooling process. In particular, as shown in FIG. 5, the suction process is preferably continued until the end of the cooling process.
And after a cooling process, as shown in FIG. 5, a weak sealing process (weak sealing work) is complete | finished, and the suction process (suctioning work) is complete | finished after that, to the container main body of a port (tubular port member). The fixing work is completed.
Then, after removing the suction means connected to the cylindrical port member 13 and injecting the drug into the drug chamber 3 of the container body 2 using the cylindrical port member 13, the lid member 14 is applied to the cylindrical port member 13. By fixing, the medical container of the present invention is manufactured.

１ 医療用容器
２ 容器本体
３ 薬剤室
７ ポート取付部
１２ ポート
１３ 筒状ポート部材
１６ 固定部
１８ 弱シール部
１９ 強シール部 DESCRIPTION OF SYMBOLS 1 Medical container 2 Container main body 3 Drug room 7 Port attachment part 12 Port 13 Cylindrical port member 16 Fixing part 18 Weak seal part 19 Strong seal part

Claims (9)

熱可塑性樹脂製材料により作製され、内部に薬剤室を有する容器本体と、前記容器本体の前記薬剤室と連通するように設けられた熱可塑性樹脂製硬質ポートとを備える医療用容器の製造方法であって、
前記医療用容器の製造方法は、弱シール金型部と、前記弱シール金型部と別個に移動可能な強シール金型部とを備えるヒートシール装置を準備する工程と、ポート取付部を有する熱可塑性樹脂製材料により構成された軟質容器本体を準備する工程と、前記熱可塑性樹脂製硬質ポートを準備する工程と、前記硬質ポートの一端側を前記容器本体のポート取付部に挿入するポート挿入工程と、前記ポート挿入工程により挿入された前記硬質ポートより前記容器本体内の空気を吸引する吸引工程と、前記挿入工程により挿入された前記硬質ポートの端部を前記容器本体に、前記ヒートシール装置の前記弱シール金型部を用いて弱シールする弱シール工程と、前記挿入工程により挿入された前記硬質ポートの前記弱シール工程により弱シールされた部分に近接しかつ前記容器本体の外縁側となる部分に、前記ヒートシール装置の前記強シール金型部を当接させ、前記弱シールより高い温度にて前記容器本体にヒートシールする強シール工程とを備え、さらに、前記吸引工程の開始は、前記弱シール工程の開始より先であり、かつ、前記弱シール工程の開始時には、前記吸引工程が継続しており、さらに、前記強シール工程は、前記弱シール工程の開始後かつ前記弱シール工程の継続中に開始されるものであることを特徴とする医療用容器の製造方法。 A method of manufacturing a medical container comprising a container body made of a thermoplastic resin material and having a drug chamber inside, and a thermoplastic resin hard port provided to communicate with the drug chamber of the container body. There,
The method for manufacturing a medical container includes a step of preparing a heat seal device including a weak seal mold part and a strong seal mold part that can be moved separately from the weak seal mold part, and a port mounting part. A step of preparing a flexible container body made of a thermoplastic resin material, a step of preparing the thermoplastic resin hard port, and a port insertion for inserting one end of the hard port into a port mounting portion of the container body A suction step of sucking air in the container body from the hard port inserted in the port insertion step, and an end portion of the hard port inserted in the insertion step in the container body, and the heat seal A weakly sealed step of weakly sealing using the weakly sealed mold part of the apparatus, and a weakly sealed portion of the hard port inserted by the inserting step by the weakly sealing step A strong sealing step in which the strong sealing mold part of the heat sealing device is brought into contact with a portion that is close to the outer edge side of the container main body and heat sealed to the container main body at a temperature higher than the weak sealing; Further, the start of the suction step is ahead of the start of the weak sealing step, and at the start of the weak sealing step, the suction step is continued, and the strong sealing step is A method for producing a medical container, which is started after the start of the weak sealing step and during the continuation of the weak sealing step. 前記吸引工程は、少なくとも前記強シール工程開始時まで行うものである請求項１に記載の医療用容器の製造方法。 The method for producing a medical container according to claim 1, wherein the suction step is performed at least until the start of the strong sealing step. 前記吸引工程は、少なくとも前記強シール工程終了時まで行うものである請求項１に記載の医療用容器の製造方法。 The method for producing a medical container according to claim 1, wherein the suction step is performed at least until the end of the strong sealing step. 前記強シール工程は、前記弱シール工程の開始後に開始され、かつ前記弱シール工程終了前に終了するものである請求項１ないし３のいずれかに記載の医療用容器の製造方法。 The method for manufacturing a medical container according to any one of claims 1 to 3, wherein the strong sealing step is started after the start of the weak sealing step and ends before the end of the weak sealing step. 前記医療用容器の製造方法は、前記強シール工程後、強シールされた部分を冷却する冷却工程を備えている請求項１ないし４のいずれかに記載の医療用容器の製造方法。 The method for manufacturing a medical container according to any one of claims 1 to 4, further comprising a cooling step for cooling a strongly sealed portion after the strong sealing step. 前記医療用容器の製造方法は、前記強シール工程後、強シールされた部分を冷却する冷却工程を備え、前記強シール工程は、前記弱シール工程の開始後に開始され、かつ前記弱シール工程終了前に終了するものであり、前記冷却工程は、前記弱シール工程継続中に開始しかつ前記弱シール工程終了前に終了するものである請求項１ないし５のいずれかに記載の医療用容器の製造方法。 The method for manufacturing a medical container includes a cooling step for cooling a strongly sealed portion after the strong sealing step, and the strong sealing step is started after the weak sealing step is started and the weak sealing step is ended. The medical container according to any one of claims 1 to 5, wherein the cooling process starts before the end of the weak sealing process and ends before the end of the weak sealing process. Production method. 前記弱シール工程は、前記硬質ポートの弱シールされる外周面部分を前記容器本体の両面側から圧迫して行うものであり、前記冷却工程は、前記弱シール工程における前記圧迫を保持した状態で行われるものである請求項６に記載の医療用容器の製造方法。 The weak sealing step is performed by pressing the outer peripheral surface portion of the hard port that is weakly sealed from both sides of the container body, and the cooling step holds the pressure in the weak sealing step. The method for producing a medical container according to claim 6, which is performed. 前記吸引工程は、前記弱シール工程終了時まで行うものである請求項２ないし７のいずれかに記載の医療用容器の製造方法。 The method for manufacturing a medical container according to any one of claims 2 to 7, wherein the suction step is performed until the end of the weak sealing step. 前記硬質ポートは、排出ポートもしくは混注ポートである請求項１ないし８のいずれかに記載の医療用容器の製造方法。 The method for manufacturing a medical container according to any one of claims 1 to 8, wherein the hard port is a discharge port or a mixed injection port.
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