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JP4555102B2 - Manufacturing method of medical container - Google Patents

Manufacturing method of medical container Download PDF

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Publication number
JP4555102B2
JP4555102B2 JP2005021726A JP2005021726A JP4555102B2 JP 4555102 B2 JP4555102 B2 JP 4555102B2 JP 2005021726 A JP2005021726 A JP 2005021726A JP 2005021726 A JP2005021726 A JP 2005021726A JP 4555102 B2 JP4555102 B2 JP 4555102B2
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JP
Japan
Prior art keywords
target member
fixing target
soft bag
bag
medical container
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
JP2005021726A
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Japanese (ja)
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JP2006204610A (en
Inventor
剛之 山口
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TRUMO KABUSHIKI KAISHA
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TRUMO KABUSHIKI KAISHA
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Priority to JP2005021726A priority Critical patent/JP4555102B2/en
Publication of JP2006204610A publication Critical patent/JP2006204610A/en
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Publication of JP4555102B2 publication Critical patent/JP4555102B2/en
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112—Single lapped joints
    • B29C66/1122—Single lap to lap joints, i.e. overlap joints
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/13—Single flanged joints; Fin-type joints; Single hem joints; Edge joints; Interpenetrating fingered joints; Other specific particular designs of joint cross-sections not provided for in groups B29C66/11 - B29C66/12
    • B29C66/133—Fin-type joints, the parts to be joined being flexible
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
    • B29C66/20—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/24—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight
    • B29C66/242—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours
    • B29C66/2422—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being circular, oval or elliptical
    • B29C66/24221—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being circular, oval or elliptical being circular
    • 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
    • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53—Joining single elements to tubular articles, hollow articles or bars
    • B29C66/532—Joining single elements to the wall of tubular articles, hollow articles or bars
    • B29C66/5326—Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
    • B29C66/53261—Enclosing tubular articles between substantially flat elements
    • B29C66/53262—Enclosing spouts between the walls of bags, e.g. of medical bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—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
    • 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
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
    • B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
    • B29C66/7232—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a non-plastics layer
    • B29C66/72321—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a non-plastics layer consisting of metals or their alloys
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
    • B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
    • B29C66/7232—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a non-plastics layer
    • B29C66/72324—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a non-plastics layer consisting of inorganic materials not provided for in B29C66/72321 - B29C66/72322
    • B29C66/72325—Ceramics
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
    • B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
    • B29C66/7234—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer
    • B29C66/72341—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer for gases
    • 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)
  • Package Specialized In Special Use (AREA)
  • Packages (AREA)
  • Making Paper Articles (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (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に、ポート、薬剤容器および薬剤容器取付用部材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、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。 Medical containers include, for example, infusion containers that store infusion drug solutions, IVH bags that store nutrients for direct administration to the central vein, bags that store 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 port, a medicine container, a medicine container attaching member, and the like to a soft bag 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, 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.

そこで、本発明は、上記問題点を解決するものであり、ポート、薬剤容器、薬剤容器取付部などの固定対象部材を構成する軟質樹脂製シートのうち固定対象部材の外周面もしくは両側に位置する部分が肉薄になりにくい医療用容器の製造方法を提供する。   Therefore, the present invention solves the above-described problems and is located on the outer peripheral surface or both sides of the fixing target member among the soft resin sheets constituting the fixing target member such as the port, the drug container, and the drug container mounting portion. Provided is a method for producing a medical container in which a portion is not easily thinned.

上記目的を達成するものは以下のとおりである。
（１）薬剤室を有する軟質バッグと、一端が該薬剤室に露出するように該軟質バッグに取り付けられた硬質固定対象部材とを有する医療用容器の製造方法であって、該製造方法は、前記軟質バッグの一端部には一端側シール部を有し、他端部には他端側シール部を有し、かつ、前記一端側シール部に該一端側シール部の一部をシールしないことにより形成された固定対象部材取付部を有する軟質樹脂製シートにより構成された軟質バッグと、前記固定対象部材とを準備する工程と、前記固定対象部材を前記軟質バッグの前記一端側シール部の一部をシールしないことにより形成された固定対象部材取付部に配置する配置工程と、前記配置工程により配置された前記固定対象部材の外周面付近を前記軟質バッグの両面側から圧迫して該固定対象部材取付部を構成するシート同士を近接もしくは接触させる固定対象部材取付部圧迫工程と、該圧迫工程による圧迫を維持した状態で圧迫された部分よりも軟質バッグ周縁側の固定対象部材取付部付近にシール用金型を押し当てることにより前記固定対象部材を前記軟質バッグにヒートシールにより固着するヒートシール工程と、前記圧迫工程によるシート同士の圧迫を保持した状態かつ、前記シール用金型を前記軟質バッグ周縁側の固定対象部材取付部より離間させた後、前記ヒートシールされた部分を冷却する冷却工程とを備える医療用容器の製造方法。
（２） 前記固定対象部材取付部圧迫工程は、前記固定対象部材の外周面部分及び該固定対象部材の両側部分を前記軟質バッグの両面側から圧迫するものである上記（１）に記載の医療用容器の製造方法。
（３） 前記冷却工程は、冷風をあてることにより行うものである請求項１または２に記載の医療用容器の製造方法。
（４） 前記固定対象部材取付部は、前記軟質バッグの内部空間側から前記の外縁に向かって拡径している上記（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） 前記固定対象部材は、排出ポート及び／若しくは混注ポート、又は、排出ポート及び／若しくは薬剤容器、薬剤容器取付用部材である上記（１）ないし４のいずれかに記載の医療用容器の製造方法。 What achieves the above objective is as follows.
(1) A method for producing a medical container having a soft bag having a drug chamber and a hard fixation target member attached to the soft bag so that one end is exposed to the drug chamber, One end portion of the flexible bag has one end side seal portion, the other end portion has another end side seal portion, and a part of the one end side seal portion is not sealed to the one end side seal portion. A step of preparing a soft bag made of a soft resin sheet having a fixing target member mounting portion formed by the step, and the fixing target member; and fixing the target member to one end side sealing portion of the soft bag. an arrangement step of arranging the fixed target member mounting portion formed by not sealing the parts, the fixed target vicinity of the outer peripheral surface of the fixed target member disposed by the disposing step and pressing from both sides of the soft bag A fixed target member mounting portion compression step of proximity or contact sheets that constitute the timber mounting portion, in the vicinity of the fixed target member mounting portion of the flexible bag peripheral side from the compression portion while maintaining the compression by said compression step a heat seal affixing by heat sealing the fixing target member to the flexible bag by pressing the sealing die, and the state was kept compression between the sheets due to the compression step, the said sealing die soft A medical container manufacturing method comprising: a cooling step of cooling the heat-sealed portion after being separated from the fixing target member attaching portion on the bag peripheral side .
(2) The medical device according to (1), wherein the fixing target member attaching portion pressing step compresses an outer peripheral surface portion of the fixing target member and both side portions of the fixing target member from both sides of the soft bag. Manufacturing method for container.
(3) the cooling step, the manufacturing method of the medical container according to claim 1 or 2 is performed by blowing cold air.
(4) The manufacturing method of the medical container according to any one of (1) to (3), wherein the fixing target member mounting portion is enlarged in diameter from the inner space side of the soft bag toward the outer edge. .
(5) The medical container according to any one of (1) to (4), wherein the fixing target member is a discharge port and / or a mixed injection port, or a discharge port and / or a drug container or a drug container mounting member . Manufacturing method .

（６） 前記固定対象部材取付部圧迫工程は、前記固定対象部材の外周面付近を前記軟質バッグの両面側から圧迫して該固定対象部材取付部を構成するシート同士を近接もしくは接触させるためのシート圧迫部を用いて行うものであり、かつ、前記圧迫部には、耐熱性硬質プラスチックを用いるものである上記（１）に記載の医療用容器の製造方法。(6) The fixing target member mounting portion pressing step is for pressing the vicinity of the outer peripheral surface of the fixing target member from both sides of the soft bag so that the sheets constituting the fixing target member mounting portion are brought close to or in contact with each other. The method for producing a medical container according to the above (1), which is performed using a sheet pressing portion, and the pressing portion uses a heat-resistant hard plastic.
（７） 前記耐熱性硬質プラスチックは、ポリエーテルエーテルケトンあるいはポリエーテルエーテルケトンのガラスもしくはカーボン強化品である上記（６）に記載の医療用容器の製造方法。(7) The method for producing a medical container according to (6), wherein the heat-resistant hard plastic is polyetheretherketone or polyetheretherketone glass or carbon reinforced product.
（８） 前記固定対象部材取付部圧迫工程は、前記固定対象部材の外周面付近を前記軟質バッグの両面側から圧迫して該固定対象部材取付部を構成するシート同士を近接もしくは接触させるためのシート圧迫部を用いて行うものであり、かつ、前記圧迫部は、内部に冷却用パイプを有するものである上記（１）に記載の医療用容器の製造方法。(8) The fixing target member mounting portion pressing step is for pressing the vicinity of the outer peripheral surface of the fixing target member from both sides of the soft bag to bring the sheets constituting the fixing target member mounting portion into proximity or in contact with each other. The method for producing a medical container according to the above (1), which is performed using a sheet pressing portion, and the pressing portion has a cooling pipe inside.

本発明は、薬剤室を有する軟質バッグと、一端が該薬剤室に露出するように該軟質バッグに取り付けられた硬質固定対象部材とを有する医療用容器の製造方法であって、該製造方法は、前記固定対象部材取付部を有する軟質樹脂製シートにより構成された軟質バッグと、前記固定対象部材とを準備する工程と、前記固定対象部材を前記軟質バッグの固定対象部材取付部に配置する配置工程と、前記配置工程により配置された前記固定対象部材の外周面付近を前記軟質バッグの両面側から圧迫して該固定対象部材取付部を構成するシート同士を近接もしくは接触させる固定対象部材取付部圧迫工程と、該圧迫工程による圧迫を維持した状態で圧迫された部分よりも軟質バッグ周縁側の固定対象部材取付部付近にて前記固定対象部材を前記軟質バッグにヒートシールにより固着するヒートシール工程とを備える医療用容器の製造方法である。
このため、本発明の医療用容器の製造方法によれば、固定対象部材取付部を構成するシートにおける固定対象部材の外周面若しくは両側に位置する部分が肉薄になりにくく、ピンホールの発生を防止できる。 The present invention is a method for manufacturing a medical container having a soft bag having a drug chamber and a hard fixation target member attached to the soft bag so that one end is exposed to the drug chamber, A step of preparing a soft bag made of a soft resin sheet having the fixing target member mounting portion and the fixing target member, and an arrangement in which the fixing target member is disposed in the fixing target member mounting portion of the soft bag A fixing target member mounting portion that presses the vicinity of the outer peripheral surface of the fixing target member disposed in the step and the placement step from both sides of the soft bag to bring the sheets constituting the fixing target member mounting portion into proximity or in contact with each other The fixing target member is positioned near the fixing target member mounting portion on the soft bag peripheral side with respect to the pressing step and a portion compressed in a state where the compression in the pressing step is maintained. A method for producing a medical container and a heat seal affixing by heat sealing the grayed.
For this reason, according to the method for manufacturing a medical container of the present invention, the portion of the sheet constituting the fixing target member mounting portion located on the outer peripheral surface or both sides of the fixing target member is not easily thinned, and the occurrence of pinholes is prevented. it can.

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、固定対象部材取付部を構成するシートにおける固定対象部材の外周面もしくは両側に位置する部分が肉薄にならないため、ピンホールが形成されることが極めて少ない。
また、本発明は、軟質樹脂製シートにより構成された薬剤室を有する軟質バッグに硬質固定対象部材をヒートシールにより取り付けるためのヒートシール用装置であって、前記固定対象部材を、その一端が前記薬剤室に露出するように前記軟質バッグに形成された固定対象部材取付部に配置した状態において、前記固定対象部材の外周面付近を前記軟質バッグの両面側から圧迫して該固定対象部材取付部を構成するシート同士を近接もしくは接触させるためのシート圧迫部と、該シート圧迫部により圧迫された状態で圧迫された部分よりも軟質バッグ周縁側の固定対象部材取付部付近にて前記固定対象部材を前記軟質バッグにヒートシールにより固着するためのシール用金型とを備えるヒートシール用装置である。
このため、本発明のヒートシール用装置によれば、固定対象部材取付部を構成するシートにおける固定対象部材の外周面もしくは両側に位置する部分が肉薄になりにくい。 Moreover, the medical container of this invention is a medical container manufactured by the said manufacturing method.
For this reason, since the medical container of this invention does not become thin in the outer peripheral surface or the part located in both sides of the fixation target member in the sheet | seat which comprises a fixation target member attaching part, a pinhole is very rarely formed.
Further, the present invention is a heat sealing device for attaching a hard fixation target member to a soft bag having a drug chamber made of a soft resin sheet by heat sealing, and the one end of the fixation target member is the In a state where the fixing target member mounting portion formed in the soft bag is exposed so as to be exposed to the medicine chamber, the fixing target member mounting portion is pressed by pressing the vicinity of the outer peripheral surface of the fixing target member from both sides of the soft bag. A sheet compression part for bringing the sheets constituting the sheet close to or in contact with each other, and the fixation target member in the vicinity of the fixation target member mounting part on the peripheral side of the soft bag with respect to a portion compressed in a state compressed by the sheet compression part Is a heat sealing device provided with a sealing mold for fixing to the soft bag by heat sealing.
For this reason, according to the apparatus for heat sealing of this invention, the part located in the outer peripheral surface or both sides of the fixation target member in the sheet | seat which comprises a fixation target member attaching part does not become thin easily.

本発明の実施例である医療用容器の製造方法、その製造方法により製造される医療用容器及びヒートシール用装置について添付図面を用いて説明する。
図１は、本発明の実施例である医療用容器の正面図であり、図２は、図１に示す医療用容器を構成する軟質バッグの正面図であり、図３は、本発明の実施例であるシール用装置の斜視図であり、図４ないし図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り、図９および図１０は、本発明の医療用容器の製造方法の実施例の圧迫工程を説明するための説明図（圧迫される部分の断面図）、図１１及び図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。なお、図１の医療用容器のポート１２若しくは薬剤容器１３（薬剤容器取付用部材１７）が配置された部分の破線の矩形部１８は、圧迫工程においてシート圧迫部２２により圧迫された部分を示す。 A medical container manufacturing method, a medical container manufactured by the manufacturing method, and a heat sealing apparatus according to an embodiment of the present invention will be described with reference to the accompanying drawings.
FIG. 1 is a front view of a medical container that is an embodiment of the present invention, FIG. 2 is a front view of a soft bag constituting the medical container shown in FIG. 1, and FIG. FIG. 4 is a perspective view of a sealing device as an example, FIG. 4 to FIG. 8 are explanatory views for explaining an embodiment of the method for manufacturing a medical container of the present invention, and FIG. 9 and FIG. FIG. 11 and FIG. 12 are explanatory diagrams (cross-sectional views of a portion to be compressed) for explaining the compression process of the embodiment of the method for manufacturing a medical container according to the present invention. It is explanatory drawing for demonstrating. In addition, the rectangular part 18 of the broken line of the part by which the port 12 or the chemical | medical agent container 13 (medicine container attachment member 17) of the medical container of FIG. 1 is arrange | positioned shows the part compressed by the sheet | seat compression part 22 in the compression process. .

本発明の医療用容器１の製造方法は、薬剤室３，４を有する軟質バッグ２と、一端が薬剤室３，４に露出するように（薬剤室３，４内に侵入するように）軟質バッグ２に取り付けられた硬質固定対象部材１２，１７とを有する医療用容器１の製造方法であって、製造方法は、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、固定対象部材１２，１７とを準備する工程と、固定対象部材１２，１７を軟質バッグ２の固定対象部材取付部７，８に配置する配置工程と、配置工程により配置された固定対象部材１２，１７の外周面付近１８を軟質バッグ２の両面側から圧迫して固定対象部材取付部７，８を構成するシート同士を近接もしくは接触させる固定対象部材取付部圧迫工程と、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固定対象部材取付部付近１９にて固定対象部材１２，１７を軟質バッグ２にヒートシールにより固着するヒートシール工程とを備える。 The manufacturing method of the medical container 1 of the present invention includes a soft bag 2 having drug chambers 3 and 4 and a soft bag so that one end is exposed to the drug chambers 3 and 4 (so as to enter the drug chambers 3 and 4). The manufacturing method of the medical container 1 having the hard fixing target members 12 and 17 attached to the bag 2, and the manufacturing method includes soft resin sheets 2 a and 2 b having fixing target member mounting portions 7 and 8. The prepared soft bag 2 and the fixing target members 12 and 17 are prepared, the fixing target members 12 and 17 are arranged in the fixing target member attaching portions 7 and 8 of the soft bag 2, and the arrangement process is performed. A fixing target member mounting portion pressing step in which the vicinity of the outer peripheral surface 18 of the fixed fixing members 12 and 17 is pressed from both sides of the soft bag 2 so that the sheets constituting the fixing target member mounting portions 7 and 8 are brought close to or in contact with each other; In the compression process A heat sealing step of fixing the fixing target members 12 and 17 to the soft bag 2 by heat sealing in the vicinity of the fixing target member attaching portion 19 on the peripheral side of the soft bag with respect to the pressed portion 18 in a state where the compression is maintained. .

まず、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、固定対象部材１２，１７とを準備する工程について説明する。
軟質樹脂製シート２ａ，２ｂにより構成された軟質バッグ２は、図１，図２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。軟質バッグ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。
実施例の軟質バッグ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。 First, a process of preparing the soft bag 2 constituted by the soft resin sheets 2a and 2b having the fixing target member attaching portions 7 and 8 and the fixing target members 12 and 17 will be described.
In the embodiment shown in FIGS. 1 and 2, the soft bag 2 constituted by the soft resin sheets 2 a and 2 b has internal spaces (medicine chambers) 3 and 4 that can store a chemical solution therein, and one end portion and The other end is sealed. One end portion of the flexible bag 2 is provided with one end side seal portion 5 and the other end portion is provided with the other end side seal portion 6. The one end side seal portion 5 and the other end side seal portion 6 are wide seal portions.
The soft bag 2 of an Example is comprised by the soft resin sheet | seats 2a and 2b which oppose obtained by making a tube-shaped molded object flat.

また、図２に示すように、軟質バッグ２の一端側シール部５には、固定対象部材取付部である排出ポート取付部７が設けられ、他端側シール部６には、固定対象部材取付部である薬剤容器取付部８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軟質バッグ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、薬剤容器取付部８は、他端側シール部６の一部をシールしないことにより軟質バッグ２の内部空間（本発明の実施例では第２の薬剤室４）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、薬剤容器取付部８は、排出ポート１２、薬剤容器取付用部材１７（薬剤容器１３）が取り付け（配置、挿入）しやすいように、それぞれ軟質バッグ２の内部空間３，４側から軟質バッグ２の外縁に向かって拡径している。   In addition, as shown in FIG. 2, the one end side seal portion 5 of the flexible bag 2 is provided with a discharge port attachment portion 7 that is a fixation target member attachment portion, and the other end side seal portion 6 is attached with a fixation target member attachment. A drug container mounting portion 8 is provided. The discharge port mounting portion 7 is provided so that the internal space of the soft bag 2 (the first drug chamber 3 in the embodiment of the present invention) and the outside communicate with each other by not sealing a part of the one end side seal portion 5. The medicine container mounting portion 8 does not seal a part of the other end side seal portion 6 so that the internal space of the soft bag 2 (second medicine chamber 4 in the embodiment of the present invention) communicates with the outside. Is provided. The discharge port mounting portion 7 and the drug container mounting portion 8 are respectively provided in the inner spaces 3 and 4 of the flexible bag 2 so that the discharge port 12 and the drug container mounting member 17 (medicine container 13) can be easily mounted (arranged and inserted). The diameter is increased from the side toward the outer edge of the soft bag 2.

また、軟質バッグ２の内部空間は、図１，図２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、軟質バッグ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構造であってもよい。
また、軟質バッグ２の一端側シール部５には、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）が形成されていてもよい。注入孔は、軟質バッグ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軟質バッグ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、軟質バッグ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、軟質バッグ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、後述するようにポート１２を構成する筒状部材１２ａを介して、また、薬剤容器取付用部材１７を介して注入されていてもよい。 As shown in FIGS. 1 and 2, the internal space of the soft bag 2 is divided into a first drug chamber 3 and a second drug chamber 4 by a partitioning weak seal portion 10 that can be peeled off. The internal space of the soft bag 2 may have a single chamber structure that is not partitioned by the partitioning weak seal portion.
Further, the one end side seal portion 5 of the soft bag 2 may be formed with an injection hole (not shown) for injecting a chemical solution stored in the first drug chamber 3. The injection hole is preferably formed so that the inner space of the soft bag 2 communicates with the outside by not sealing a part of the one end side seal portion 5 of the soft bag 2. Further, the other end side seal portion 6 of the soft bag 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) communicates with the outside by not sealing a part of the other end side seal portion 6 of the soft bag 2. The injection hole is sealed after the drug solution is injected into the first drug chamber 3 or the second drug chamber 4. In addition, the chemical solution may be injected through a cylindrical member 12a constituting the port 12 as described later, or through a drug container mounting member 17.

軟質バッグ２は、軟質合成樹脂により作製されている。軟質バッグ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、軟質バッグ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、軟質バッグ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、軟質バッグ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。 The soft bag 2 is made of a soft synthetic resin. The flexible bag 2 is preferably formed into a cylindrical shape by an inflation molding method. The soft bag 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 flexible bag 2 is bent flatly in a manufacturing process, and two sides are formed. Moreover, you may form the bent side by lightly pressing as needed.
The soft bag 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).

このように軟質バッグ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。このような軟質バッグ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。軟質バッグ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、軟質バッグ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。   Thus, since the soft bag 2 has a water vapor barrier property, transpiration of water 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 such a flexible bag 2 include polyolefins such as polyethylene (PE), polypropylene (PP), polybutadiene, and 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 flexible bag 2, a bag in which the inner surface of the heat-sealed portion is made of a thermoplastic synthetic resin is used. In particular, the soft bag 2 is preferably one in which the entire inner surface or the entire bag is made of a thermoplastic synthetic resin.

また、軟質バッグ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、軟質バッグ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。軟質バッグ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、軟質バッグ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、軟質バッグ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、軟質バッグ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 soft bag 2, the usefulness of the present invention is great. Therefore, in the present invention, it is preferable that the material for forming the flexible bag 2 includes polyolefin. As a material for forming the flexible bag 2, a soft material obtained by blending a styrene-based thermoplastic elastomer such as a styrene-butadiene copolymer or a styrene-ethylene-butylene-styrene block copolymer with a polyethylene or polypropylene is softened. Resins can be mentioned. 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 soft bag 2 can be improved, or anti-blocking properties can be imparted. Moreover, in the case of a thing with a metal layer, the gas barrier property etc. of the soft bag 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 soft bag 2 is a multilayer laminated body, it is preferable that the material which forms the inner surface part is the material mentioned above.

軟質バッグ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。
軟質バッグ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 flexible bag 2 is appropriately determined according to 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 flexible bag 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２に示すように、軟質バッグ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により軟質バッグ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、軟質バッグ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 soft bag 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 dividing the inside of the soft bag 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 soft bag 2 (medical container 1) is not limited to the one provided with the partition weak seal portion, and may have a single chamber structure.

また、軟質バッグ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）１６が設けられていることが好ましい。
軟質バッグ２に取り付けられる硬質固定対象部材としては、排出ポート及び／若しくは混注ポート、又は、排出ポート及び／若しくは薬剤容器、薬剤容器取付用部材であることが好ましい。本発明の実施例では軟質バッグ２の下端部に排出ポート１２が取り付けられ、上端部に薬剤容器取付用部材１７（薬剤容器１３）が取り付けられている。
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部材１２ａと、筒状部材１２ａの一端側の開口部を封止するシール部材を有する蓋部１２ｂ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 part 6 of the soft bag 2 is provided with a hole (hanging part) 16 for hanging on a hanger or the like.
The member to be rigidly fixed attached to the soft bag 2 is preferably a discharge port and / or a mixed injection port, or a discharge port and / or a medicine container or a medicine container attachment member. In the embodiment of the present invention, the discharge port 12 is attached to the lower end portion of the soft bag 2, and the medicine container attaching member 17 (the medicine container 13) is attached to the upper end portion.
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 is preferably composed of a cylindrical member 12a that is open at both ends, and a lid portion 12b that has a seal member that seals the opening at one end of the cylindrical member 12a. .

また、シール部材は、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、ポリエチレン、ポリプロピレン、エチレン−プロピレン共重合体、エチレン−酢酸ビニル共重合体、架橋型エチレン−酢酸ビニル共重合体等のポリオレフィン、ポリエステル、ポリ塩化ビニル、ポリウレタン、ポリアミドなどの可撓性高分子材料、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 has a self-occlusion property, and after the needle tube is extracted from the elastic body, the puncture hole is closed to prevent the leakage of the chemical solution. Examples of the constituent material of the sealing material include polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and cross-linked ethylene-vinyl acetate copolymer, polyester, polyvinyl chloride, polyurethane, Flexible polymer materials such as polyamide, thermoplastic resins such as polyamide elastomer and polyester elastomer (thermoplastic elastomer), natural rubber, isoprene rubber, silicone rubber, butadiene rubber, various rubber materials such as styrene-butadiene rubber, etc. An elastic material or a combination of any two or more of these materials can be used, and those containing an elastic material are preferable from the viewpoint of sealing performance and resealability. 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軟質バッグ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。
また、本発明で使用される薬剤容器１３としては、公知のものを使用することが好ましく、本発明の実施例では、薬剤収納部１４と薬剤収納部１４の端部に設けられ軟質バッグ２内部において薬剤収納部１４が軟質バッグ２内と連通可能に隔離する連通規制部１５を有するものが使用されている。本発明の実施例において、連通規制部１５は薬剤収納部１４の端部と連続する脆弱部１５ｂと連続して設けられた操作部１５ａからなり、操作部１５ａを折り曲げることにより脆弱部１５ｂが破断して薬剤収納部１４が開口し軟質バッグ２内部と連通するものとなっている。 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. Moreover, it is preferable to form the mixed injection port mounting part by not sealing one end side seal part or the other end side seal part of the soft bag 2.
Moreover, it is preferable to use a well-known thing as the chemical | medical agent container 13 used by this invention. In the Example of this invention, it is provided in the edge part of the chemical | medical agent storage part 14 and the chemical | medical agent storage part 14, and the inside of the soft bag 2 is used. The medicine storage part 14 has a communication restriction part 15 that is isolated so as to be able to communicate with the inside of the soft bag 2. In the embodiment of the present invention, the communication restricting portion 15 includes an operation portion 15a provided continuously with a weak portion 15b continuous with the end portion of the medicine storage portion 14, and the weak portion 15b is broken by bending the operation portion 15a. Then, the medicine container 14 is opened and communicates with the inside of the soft bag 2.

薬剤収納部１４内に充填される薬剤としては、粉末、顆粒状などの固体状、液体状等のいかなるものでもよい。薬剤としては、輸液剤に配合・溶解させるものであって、例えば抗生物質、ビタミン剤（総合ビタミン剤）、各種アミノ酸、ヘパリン等の抗血栓剤、インシュリン、抗腫瘍剤、鎮痛剤、強心剤、静注麻酔剤、抗パーキンソン剤、潰瘍治療剤、副腎皮質ホルモン剤、不整脈用剤、補正電解質、抗ウィルス薬、免疫賦活剤等が挙げられる。また、薬剤収納部は、常圧でもよいが、減圧または真空状態としてもよい。このように、薬剤収納部が減圧または真空状態であると、薬剤の変質分解・劣化等の防止効果が向上するとともに、連通規制部の破断時に、輸液剤を吸引し、より迅速に薬剤収納部へ導入することができる。   The drug filled in the drug container 14 may be any powder, granular or other solid, liquid or the like. Drugs are formulated and dissolved in infusions. For example, antibiotics, vitamins (general vitamins), various amino acids, antithrombotic agents such as heparin, insulin, antitumor agents, analgesics, cardiotonics, statics Note: Anesthetic agents, anti-Parkinson agents, ulcer treatment agents, corticosteroid agents, arrhythmia agents, correction electrolytes, antiviral agents, immunostimulants, and the like. Moreover, although a chemical | medical agent storage part may be a normal pressure, it is good also as a pressure reduction or a vacuum state. Thus, when the medicine container is in a reduced pressure or vacuum state, the effect of preventing degradation, degradation, degradation, etc. of the drug is improved, and when the communication restriction part is broken, the infusion is sucked and the medicine container is more quickly Can be introduced.

本発明の実施例では、薬剤容器１３は、図１に示すように、薬剤容器取付用部材１７を介して軟質バッグ２に取り付けられる。
薬剤容器取付用部材１７としては、例えば、内部に薬剤容器１３を挿入することにより薬剤容器１３を軟質バッグ２に液密に取り付け可能なものであることが好ましい。具体的に、薬剤容器取付用部材１７は、内部に薬剤容器１３を挿入して液密に取り付け可能な筒状部材であることが好ましい。このような薬剤容器取付用部材１７を、後述するように、軟質バッグ２にヒートシールにより固着した後、薬剤容器取付用部材１７に薬剤容器１３を挿入し、高周波融着、接着剤等により接合させることにより薬剤容器１３が軟質バッグ２に取り付けられる。また、本発明の実施例では、薬剤容器取付用部材１７を介して軟質バッグ２の内部空間に薬液を注入することができる。 In the embodiment of the present invention, the medicine container 13 is attached to the soft bag 2 via the medicine container attaching member 17 as shown in FIG.
The member 17 for attaching a medicine container is preferably a member that can be attached to the soft bag 2 in a liquid-tight manner by inserting the medicine container 13 therein, for example. Specifically, the drug container mounting member 17 is preferably a cylindrical member that can be liquid-tightly inserted by inserting the drug container 13 therein. As will be described later, such a drug container mounting member 17 is fixed to the soft bag 2 by heat sealing, and then the drug container 13 is inserted into the drug container mounting member 17 and bonded by high frequency fusion, an adhesive, or the like. By doing so, the medicine container 13 is attached to the soft bag 2. In the embodiment of the present invention, the drug solution can be injected into the internal space of the soft bag 2 through the drug container mounting member 17.

排出ポート１２、薬剤容器１３、混注ポート、薬剤容器取付用部材１７の構成材料としては、軟質バッグ２と相溶性を有する樹脂であることが好ましい。また、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組み合わせたものが挙げられる。   The constituent material of the discharge port 12, the drug container 13, the mixed injection port, and the drug container mounting member 17 is preferably a resin that is compatible with the soft bag 2. Moreover, it is preferable that it is a hard material. 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, Inc.)), 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 include a combination of these as desired.

次に、固定対象部材１２，１７を軟質バッグ２の固定対象部材取付部７，８に配置する配置工程について図１，図４，図９を用いて説明する。図４，図９は、排出ポート１２の配置についての説明図であるが、排出ポート１２を薬剤容器取付用部材１７に置き換えれば取付用部材１７の説明図となる（後述する圧迫工程、冷却工程についても同様）。
配置工程は、図４，図９に示すように、排出ポート１２を軟質バッグ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に挿入し、薬剤容器取付用部材１７を、他端側シール部６に設けられた薬剤容器取付部８に挿入することにより行われる。なお、薬剤容器１３を薬剤容器取付用部材１７を介さず直接軟質バッグ２に取り付ける場合は、薬剤容器１３が薬剤容器取付部８に直接挿入される。配置工程においては、後述するシート圧迫部２２による軟質バッグ２の固定対象取付部７，８の圧迫はなされていない。 Next, the arrangement | positioning process which arrange | positions the fixation object members 12 and 17 in the fixation object member attachment parts 7 and 8 of the soft bag 2 is demonstrated using FIG.1, FIG.4, FIG.9. 4 and 9 are explanatory views of the arrangement of the discharge port 12. However, if the discharge port 12 is replaced with the medicine container mounting member 17, the mounting member 17 will be described (a compression process and a cooling process to be described later). The same applies to.
As shown in FIGS. 4 and 9, the disposing process is such that the discharge port 12 is inserted into the discharge port mounting portion 7 provided on the one end side seal portion 5 of the soft bag 2, and the drug container mounting member 17 is connected to the other end. It is carried out by inserting the medicine container mounting portion 8 provided in the side seal portion 6. In addition, when attaching the medicine container 13 directly to the soft bag 2 without using the medicine container attaching member 17, the medicine container 13 is directly inserted into the medicine container attaching portion 8. In the arrangement step, the fixing target attachment portions 7 and 8 of the soft bag 2 are not compressed by the sheet compression portion 22 described later.

図４，図９に示すように、排出ポート１２（薬剤容器取付用部材１７）を配置しただけの状態では、固定対象部材取付部７（８）を構成する上端側のシート２ａと下端側のシート２ｂのうち排出ポート１２（取付用部材１７）と近接する部分（排出ポート１２、取付用部材１７の外周面付近）は離間している。また、この状態において固定対象部材取付部７，８を構成するシートの排出ポート１２（取付用部材１７）と近接する部分（排出ポート１２，取付用部材１７の外周面付近）には、ある程度テンションがかかっている。
この状態で、図６に示すように、シール用金型２６を用いてヒートシールすると、シール用金型２６の押圧に対するシート２ａとシート２ｂの反発により、固定対象取付部７（８）を構成するシート２ａ，２ｂのうち、固定対象部材１２（１７）の外周面上もしくは両側に位置する部分が肉薄になり易くなる。 As shown in FIGS. 4 and 9, in the state where the discharge port 12 (medicine container mounting member 17) is simply disposed, the upper end side sheet 2 a and the lower end side constituting the fixing target member mounting portion 7 (8) are arranged. A portion of the sheet 2b adjacent to the discharge port 12 (the mounting member 17) (near the outer peripheral surface of the discharge port 12 and the mounting member 17) is separated. In this state, a portion of the sheet constituting the fixing target member attaching portions 7 and 8 adjacent to the discharge port 12 (attachment member 17) (near the outer peripheral surface of the discharge port 12 and attachment member 17) has some tension. Is on.
In this state, as shown in FIG. 6, when heat sealing is performed using the sealing mold 26, the fixing target mounting portion 7 (8) is configured by the repulsion of the sheet 2 a and the sheet 2 b against the pressing of the sealing mold 26. Of the sheets 2a and 2b, the portions located on the outer peripheral surface or both sides of the fixing target member 12 (17) are likely to be thin.

なお、本発明の実施例において、排出ポート１２の配置は、ポート１２を構成する筒状部材１２ａを排出ポート取付部７に挿入することにより行われている。そして、後述する圧迫工程及びヒートシール工程により、筒状部材１２ａを軟質バッグ２に取り付けた後、蓋部１２ｂを筒状部材１２ａに取り付けることにより、排出ポートを組み立てている。このようにすることにより、蓋部１２ｂを取り付ける前のポート１２を構成する筒状部材１２ａを用いて、軟質バッグ２内に薬液を注入することができる。   In the embodiment of the present invention, the discharge port 12 is arranged by inserting the cylindrical member 12 a constituting the port 12 into the discharge port mounting portion 7. And after attaching the cylindrical member 12a to the soft bag 2 by the compression process and heat sealing process which are mentioned later, the discharge port is assembled by attaching the cover part 12b to the cylindrical member 12a. By doing in this way, a chemical | medical solution can be inject | poured in the soft bag 2 using the cylindrical member 12a which comprises the port 12 before attaching the cover part 12b.

次に、配置工程により配置された固定対象部材１２，１７の外周面付近１８を圧迫して固定対象部材取付部７，８を構成するシート２ａ，２ｂ同士を近接もしくは接触させる固定対象部材取付部圧迫工程を図５ないし図７及び図１０，図１１，図１２を用いて説明する。
本発明の実施例において圧迫工程は、固定対象部材１２，１７の外周面部分１８ａ及び固定対象部材１２，１７の両側部分１８ｂを圧迫するものである。さらに、本発明の実施例の圧迫工程は、固定対象部材１２，１７の両側部分１８ｂの軟質バッグ側辺側部分１８ｃも圧迫している。本発明の実施例においては、軟質バッグ側辺側部分１８ｃは、固定対象部材取付部７，８の両側に位置する幅広シール部の一部である。本発明の実施例では、図１１，図１２に示すように、軟質バッグ２は、圧迫工程により矩形状に圧迫されている。 Next, the fixing target member mounting portion that presses the vicinity 18 of the outer peripheral surface of the fixing target members 12 and 17 arranged in the arranging step so that the sheets 2a and 2b constituting the fixing target member mounting portions 7 and 8 come close to or contact each other. The pressing process will be described with reference to FIGS. 5 to 7, 10, 11, and 12.
In the embodiment of the present invention, the pressing step compresses the outer peripheral surface portion 18 a of the fixing target members 12 and 17 and the both side portions 18 b of the fixing target members 12 and 17. Furthermore, in the compression process of the embodiment of the present invention, the soft bag side portion 18c of the both side portions 18b of the fixation target members 12 and 17 is also compressed. In the Example of this invention, the soft bag side part 18c is a part of the wide seal part located in the both sides of the fixation object member attachment parts 7 and 8. FIG. In the embodiment of the present invention, as shown in FIGS. 11 and 12, the soft bag 2 is compressed into a rectangular shape by a compression process.

本発明の製造方法における圧迫工程およびヒートシール工程にて使用されるシール用装置２０は、図３に示すように、軟質樹脂製シート２ａ，２ｂにより構成された軟質バッグ２に、固定対象部材１２，１７をヒートシールにより取り付けるための装置である。
本発明の製造方法の圧迫工程に使用されるヒートシール用装置２０は、図３に示すように、軟質樹脂製シート２ａ，２ｂにより構成された薬剤室３，４を有する軟質バッグ２に硬質固定対象部材１２，１７をヒートシールにより取り付けるためのヒートシール用装置２０であって、固定対象部材１２，１７を、その一端が薬剤室３，４に露出するように（薬剤室３，４内に侵入するように）軟質バッグ２に形成された固定対象部材取付部７，８に配置した状態において、固定対象部材１２，１７の外周面付近１８を軟質バッグ２の両面側から圧迫（言い換えると、狭圧、以下同様）して固定対象部材取付部１２，１７を構成するシート２ａ，２ｂ同士を近接もしくは接触（好ましくは接触）させるためのシート圧迫部２２（言い換えると、シート狭圧部２２）と、シート圧迫部２２により圧迫された状態で圧迫された部分１８よりもバッグ周縁側の固定対象部材取付部付近１９にて固定対象部材１２，１７を軟質バッグ２にヒートシールにより固着するためのシール用金型２６とを備える。 As shown in FIG. 3, the sealing device 20 used in the compression process and the heat sealing process in the manufacturing method of the present invention is attached to the soft bag 2 composed of the soft resin sheets 2 a and 2 b, and the fixing target member 12. , 17 for attaching by heat sealing.
As shown in FIG. 3, the heat sealing device 20 used in the compression process of the manufacturing method of the present invention is rigidly fixed to the soft bag 2 having the drug chambers 3 and 4 constituted by the soft resin sheets 2a and 2b. A heat sealing device 20 for attaching the target members 12 and 17 by heat sealing, the fixing target members 12 and 17 being exposed to the drug chambers 3 and 4 at one end (in the drug chambers 3 and 4). In a state where the fixing target member attaching portions 7 and 8 formed on the soft bag 2 are arranged so as to invade, the vicinity 18 of the outer peripheral surface of the fixing target members 12 and 17 is pressed from both sides of the soft bag 2 (in other words, The sheet pressing portion 22 (in other words, a sheet pressure portion 22) for bringing the sheets 2a and 2b constituting the fixing target member mounting portions 12 and 17 close to each other or making contact (preferably contact) with each other. The fixing target members 12 and 17 are heated to the soft bag 2 in the vicinity of the fixing target member attaching portion 19 on the bag peripheral side with respect to the portion 18 compressed in the compressed state by the sheet pressing portion 22). And a sealing die 26 for fixing with a seal.

この実施例のシール用装置２０のシート圧迫部２２は、軟質バッグ２の一方の面側及び他方の面側から固定対象部材１２，１７の外周面付近の薬剤室側に位置する部分１８を押圧し、固定対象部材１２，１７を構成するシート２ａ，２ｂ同士を近接もしくは接触させるためのものである。本発明の実施例においては、シート圧迫部２２は、固定対象部材１２，１７の外周面部分１８ａ及び固定対象部材１２，１７の両側部分１８ｂを圧迫するものであることが好ましい。さらに、実施例のシート圧迫部２２は、固定対象部材１２，１７の両側に位置する部分１８ｂの軟質バッグ側辺側まで軟質バッグ２を圧迫するものである。具体的に、シート圧迫部２２は、図３に示すように、軟質バッグ２の一方の面側（シート２ａ側）から押圧する第１の圧迫部（狭圧部）２３と、軟質バッグ２の他方の面側（シート２ｂ側）から押圧する第２の圧迫部（狭圧部）２４とを備えている。   The sheet pressing portion 22 of the sealing device 20 of this embodiment presses the portion 18 located on the drug chamber side near the outer peripheral surface of the fixation target members 12 and 17 from the one surface side and the other surface side of the flexible bag 2. In addition, the sheets 2a and 2b constituting the fixing target members 12 and 17 are brought close to or in contact with each other. In the embodiment of the present invention, it is preferable that the sheet pressing portion 22 presses the outer peripheral surface portion 18 a of the fixing target members 12 and 17 and the both side portions 18 b of the fixing target members 12 and 17. Further, the seat pressing portion 22 of the embodiment presses the soft bag 2 to the soft bag side of the portions 18b located on both sides of the fixing target members 12 and 17. Specifically, as shown in FIG. 3, the sheet compression portion 22 includes a first compression portion (narrow pressure portion) 23 that is pressed from one surface side (sheet 2 a side) of the flexible bag 2, and the flexible bag 2. And a second pressing portion (narrow pressure portion) 24 that is pressed from the other surface side (sheet 2b side).

第１の圧迫部２３は、図３に示すように、固定対象部材１２，１７の外面形状に対応した表面形状を備える圧迫面（狭圧面）２３ａと、圧迫面２３ａの両側に形成された圧迫面（狭圧面）２３ｂとからなる。圧迫面２３ａ，２４ａが固定対象部材１２，１７の外周面１８ａを圧迫する部分であり、圧迫面２３ｂ，２４ｂが固定対象部材１２，１７の両側部分１８ｂ及び両側部分１８ｂの軟質バッグ側辺側部分１８ｃを圧迫する部分となっている。本発明の実施例では、圧迫面２３ａは、アーチ状に形成され、圧迫面２３ｂは、平坦に形成されている。第２の圧迫部２４は、図３に示すように、固定対象部材１２，１７の外面形状に対応した表面形状を備える圧迫面（挟圧面）２４ａと、圧迫面２４ａの両側に形成された圧迫面（挟圧面）２４ｂとからなる。本発明の実施例では、圧迫面２４ａは、アーチ状に形成され、圧迫面２４ｂは平坦に形成されている。   As shown in FIG. 3, the first compression portion 23 includes a compression surface (narrow pressure surface) 23a having a surface shape corresponding to the outer surface shape of the fixation target members 12 and 17, and compression formed on both sides of the compression surface 23a. And a surface (narrow pressure surface) 23b. The compression surfaces 23a and 24a are portions that press the outer peripheral surface 18a of the fixation target members 12 and 17, and the compression surfaces 23b and 24b are the side portions 18b and the side portions 18b of the fixation target members 12 and 17 on both sides. It is a part which presses 18c. In the embodiment of the present invention, the compression surface 23a is formed in an arch shape, and the compression surface 23b is formed flat. As shown in FIG. 3, the second compression portion 24 includes a compression surface (clamping surface) 24a having a surface shape corresponding to the outer surface shape of the fixation target members 12 and 17, and compression formed on both sides of the compression surface 24a. And a surface (clamping surface) 24b. In the embodiment of the present invention, the compression surface 24a is formed in an arch shape, and the compression surface 24b is formed flat.

また、本発明のシート圧迫部２２は、図１，図５，図６，図７，図９，図１１，図１２に示すように、固定対象部材１２，１７の外周面付近の薬剤室側に位置する部分１８を圧迫するものである。このため、本発明の実施例によれば固定対象部材１２，１７付近のシート２ａ，２ｂ同士を確実に近接もしくは接触させることができる。
このようなシール用装置２０のシート圧迫部２２（シート狭圧部２２）を用いて圧迫工程を行う。
第１の圧迫部２３により軟質バッグ２の一方の面側（シート２ａ側）から固定対象部材１２（１７）の外周面上の薬剤室側に位置する部分１８ａ、固定対象部材１２（１７）の両側に位置する部分１８ｂ、部分１８ｂの軟質バッグ側辺側部分１８ｃが押圧される。 Further, as shown in FIGS. 1, 5, 6, 7, 9, 11, and 12, the sheet compression portion 22 according to the present invention is provided on the drug chamber side near the outer peripheral surface of the fixation target members 12 and 17. The portion 18 positioned at the position is pressed. For this reason, according to the Example of this invention, the sheet | seats 2a and 2b of the fixing object members 12 and 17 vicinity can be reliably approached or contacted.
The compression process is performed using the sheet compression portion 22 (sheet narrow pressure portion 22) of the sealing device 20 as described above.
The portion 18a located on the medicine chamber side on the outer peripheral surface of the fixation target member 12 (17) from the one surface side (sheet 2a side) of the flexible bag 2 by the first compression portion 23, the fixation target member 12 (17). The portion 18b located on both sides, and the soft bag side portion 18c of the portion 18b are pressed.

また、第２の圧迫部２４により軟質バッグ２の他方の面側（シート２ｂ側）から固定対象部材１２（１７）の外周面上の薬剤室側に位置する部分１８ａ、固定対象部材１２（１７）の両側に位置する部分１８ｂ、部分１８ｂの軟質バッグ側辺側部分１８ｃが押圧される。
本発明の実施例では、図１０に示すように、第１の圧迫部２３及び第２の圧迫部２４の押圧により固定対象部材１２，１７を構成するシート２ａ，２ｂ同士が近接もしくは接触している。具体的に、第１の圧迫部２３及び第２の圧迫部２４の押圧により固定対象部材１２，１７を構成するシート２ａ，２ｂの圧迫された部分より軟質バッグ周縁側（ヒートシールされる部分）が近接もしくは接触している。なお、圧迫工程により固定対象部材１２，１７の外周面付近のシート２ａ，２ｂを近接させる場合の近接の程度は、後述するヒートシール工程において、固定対象部材１２，１７の外周面上若しくは固定対象部材１２，１７の両側に位置するシートが肉薄にならない程度であればよい。 Further, the portion 18a positioned on the drug chamber side on the outer peripheral surface of the fixation target member 12 (17) from the other surface side (sheet 2b side) of the soft bag 2 by the second compression portion 24, the fixation target member 12 (17 ) Are positioned on both sides, and the soft bag side portion 18c of the portion 18b is pressed.
In the embodiment of the present invention, as shown in FIG. 10, the sheets 2 a and 2 b constituting the fixing target members 12 and 17 are brought close to or in contact with each other by pressing of the first compression portion 23 and the second compression portion 24. Yes. Specifically, the soft bag peripheral side (the portion to be heat-sealed) from the pressed portion of the sheets 2a and 2b constituting the fixing target members 12 and 17 by the pressing of the first compression portion 23 and the second compression portion 24. Are close or in contact. Note that the degree of proximity when the sheets 2a and 2b in the vicinity of the outer peripheral surfaces of the fixing target members 12 and 17 are brought close to each other in the compression process is determined on the outer peripheral surfaces of the fixing target members 12 and 17 or the fixing target in the heat sealing process described later. It is sufficient that the sheets positioned on both sides of the members 12 and 17 are not thinned.

この実施例における圧迫工程では、図１０に示すように、固定対象部材１２（１７）の両側の薬剤室側に位置する部分１８ｂとともに固定対象部材１２（１７）の外周面上の薬剤室側に位置する部分１８ａも圧迫するように固定対象部材と圧迫面との形状を設定し、これによって外周面上の部分、特に固定対象部材の両側近傍を圧迫している。これにより、固定対象部材１２（１７）を構成するシート２ａ，２ｂのうち固定対象部材１２（１７）の外周面１８ａ及び固定対象部材の両側に位置する部分１８ｂが確実に圧迫され、ヒートシール対象部位のシート同士が確実に近接もしくは接触するとともに固定対象部材１２（１７）もシートに確実に接触する。   In the compression process in this embodiment, as shown in FIG. 10, the portions 18b located on the drug chamber sides on both sides of the fixation target member 12 (17) and the drug chamber side on the outer peripheral surface of the fixation target member 12 (17). The shape of the fixation target member and the compression surface is set so that the portion 18a positioned is also compressed, thereby compressing the portion on the outer peripheral surface, particularly the vicinity of both sides of the fixation target member. As a result, the outer peripheral surface 18a of the fixing target member 12 (17) and the portions 18b located on both sides of the fixing target member of the sheets 2a and 2b constituting the fixing target member 12 (17) are surely pressed, and the heat sealing target The sheets in the region are in close proximity to or in contact with each other, and the fixing target member 12 (17) is also in contact with the sheet with certainty.

なお、本発明の実施例において、圧迫工程は固定対象部材１２（１７）の薬剤室側に位置する部分のシートを圧迫することにより行われているが、これに限定されるものではない。
以上のような圧迫工程を行うことにより、固定対象部材取付部７，８を構成するシート２ａ，２ｂ同士を確実に圧迫した状態で、シール用金型２６を用いて次工程であるヒートシール工程を容易に行うことができる。
なお、本発明の実施例では、固定対象部材取付部７，８を構成するシート２ａ，２ｂ同士の圧迫は、固定対象部材１２（１７）の両側に位置するシート２ａ，２ｂ同士が接触するように行われているがこれに限定されるものではない。圧迫工程は、例えば、シール用金型２６の押圧に対するシート２ａ，２ｂ同士の反発により固定対象部材１２（１７）の外周面もしくは両側に位置するシート２ａ，２ｂが肉薄にならない程度に所定距離離間した状態に圧迫するものであってもよい。 In the embodiment of the present invention, the pressing step is performed by pressing the sheet of the portion located on the drug chamber side of the fixation target member 12 (17), but is not limited thereto.
By performing the above-described compression process, the heat sealing process, which is the next process, is performed using the sealing mold 26 in a state where the sheets 2a and 2b constituting the fixing target member attaching portions 7 and 8 are reliably compressed. Can be easily performed.
In addition, in the Example of this invention, the sheet | seats 2a and 2b which comprise the fixation object member attachment part 7 and 8 are pressed so that the sheet | seats 2a and 2b located in the both sides of the fixation object member 12 (17) may contact. However, the present invention is not limited to this. In the pressing step, the sheets 2a and 2b positioned on the outer peripheral surface or both sides of the fixing target member 12 (17) are separated by a predetermined distance due to, for example, repulsion between the sheets 2a and 2b against the pressing of the sealing mold 26. It may be one that squeezes into the state.

また、上述したシール用装置２０における狭圧部は、軟質バッグの両面側から固定対象部材の外周面部分及び固定対象部材の両側部分を圧迫するものとなっているがこれに限定されるものではない。例えば、固定対象部材の外周面部分のみ圧迫するものであってもよい。また、固定対象部材の両側部分のみ圧迫するものであってもよい。また、シール用装置における圧迫部の構成材料としては、シール用金型と同様の金属材料や耐熱性のある硬質プラスチック等を使用することができる。なお、圧迫部の近傍には加熱金型が存在し、加熱金型が発生する熱の影響を受けやすい位置であることから、圧迫部には内部に冷却用パイプを配して水や油等の熱伝導体を流通させて冷却したり、また表面に断熱材を設けて金属材料に熱が伝わりにくくすることが好ましい。さらに、構成材料としてＰＥＥＫ（ポリエーテルエーテルケトン）あるいはそのガラスやカーボン強化品等の耐熱性硬質プラスチックを用いることが好ましい。   In addition, the narrow pressure portion in the sealing device 20 described above compresses the outer peripheral surface portion of the fixing target member and both side portions of the fixing target member from both sides of the soft bag, but is not limited thereto. Absent. For example, only the outer peripheral surface portion of the fixing target member may be compressed. Further, only the both side portions of the fixing target member may be pressed. Further, as a constituent material of the compression portion in the sealing device, a metal material similar to the sealing mold, a hard plastic having heat resistance, or the like can be used. In addition, since there is a heating mold in the vicinity of the compression part and it is a position that is easily affected by the heat generated by the heating mold, a cooling pipe is provided inside the compression part to provide water, oil, etc. It is preferable to circulate and cool the heat conductor, or to provide a heat insulating material on the surface to make it difficult for heat to be transmitted to the metal material. Further, it is preferable to use PEEK (polyetheretherketone) or a heat-resistant hard plastic such as glass or carbon reinforced product as a constituent material.

次に、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よりもバッグ周縁側の固定対象部材取付部付近１９にて固定対象部材１２（１７）を軟質バッグ２に固着するヒートシール工程について図６を用いて説明する。本発明の実施例のヒートシール工程は、上述したシール用金型２６を用いて行われる。   Next, a heat sealing step of fixing the fixing target member 12 (17) to the soft bag 2 in the vicinity of the fixing target member attaching portion 19 closer to the bag peripheral side than the portion 18 compressed in a state in which the compression in the pressing step is maintained. This will be described with reference to FIG. The heat sealing process of the embodiment of the present invention is performed using the sealing mold 26 described above.

ヒートシール工程について使用されるシール用金型２６は、図３に示すように、軟質バッグ２の一方の面側（一方のシート２ａ側）に押しつけられる第１の金型２８と、軟質バッグ２の他方の面側（他方のシート２ｂ側）に押しつけられる第２の金型２９とを備える。また、シール用金型２６は、シート狭圧部２２の前方に隣接して形成されている。
第１の金型２８は、固定対象部材１２（１７）の外面形状に対応した表面形状を備える固定対象部材外周部用シール面２８ａと、固定対象部材外周部用シール面２８ａの両側に設けられ、軟質バッグ２の固定対象部材１２（１７）の両側部分をシールするための固定対象部材近接部用シール面２８ｂとを有している。本発明の実施例では、シール面２８ａは、アーチ状に形成され、シール面２８ｂは平坦に形成されている。 As shown in FIG. 3, the sealing mold 26 used for the heat sealing process includes a first mold 28 pressed against one surface side (one sheet 2 a side) of the flexible bag 2, and the flexible bag 2. And a second mold 29 pressed against the other surface side (the other sheet 2b side). The sealing mold 26 is formed adjacent to the front of the sheet narrow pressure portion 22.
The 1st metal mold | die 28 is provided in the both sides of the sealing target member outer peripheral part seal surface 28a provided with the surface shape corresponding to the outer surface shape of the fixing target member 12 (17), and the fixing target member outer peripheral part seal surface 28a. The fixing target member proximity portion sealing surface 28b for sealing both side portions of the fixing target member 12 (17) of the soft bag 2 is provided. In the embodiment of the present invention, the sealing surface 28a is formed in an arch shape, and the sealing surface 28b is formed flat.

第２の金型２９は、固定対象部材１２（１７）の外面形状に対応した表面形状を備える固定対象部材外周部用シール面２９ａと、固定対象部材外周部用シール面２９ａの両側に設けられ、軟質バッグ２の固定対象部材１２（１７）の両側部分をシールするための固定対象部材近接部用シール面２９ｂとを有している。本発明の実施例では、シール面２９ａは、アーチ状に形成され、シール面２９ｂは平坦に形成されている。
ヒートシール工程は、図６に示すように、固定対象部材取付部７，８を構成するシート２ａ，２ｂを圧迫（狭圧）した状態において、固定対象部材１２（１７）の外周面及びその両側に位置するシート２ａ，２ｂを押圧するとともに加熱することにより行われる。また、この実施例のヒートシール工程は、図１、図４ないし図８に示すように、圧迫工程において圧迫される部分より軟質バッグ２の周縁側にヒートシール１９を施すものである。固定対象部材取付部および固定対象部材に対する圧迫とヒートシールとをこのような位置関係で実施することにより、固定対象部材を挟持した固定対象部材両側部分に生じるヒートシール用金型の押圧に対するシート２ａ，２ｂの反発力を予めなくすことができる。また、圧迫とヒートシールがこのような位置関係で行われることにより、シール用金型２６により形成されるヒートシール１９の薬剤室側端部（薬剤室内の薬液と接触する部分）にピンホールが生じることを確実に防止することができる。 The second mold 29 is provided on both sides of the fixing target member outer periphery sealing surface 29a having a surface shape corresponding to the outer surface shape of the fixing target member 12 (17) and the fixing target member outer periphery sealing surface 29a. The fixing target member proximity portion sealing surface 29b for sealing both side portions of the fixing target member 12 (17) of the soft bag 2 is provided. In the embodiment of the present invention, the seal surface 29a is formed in an arch shape, and the seal surface 29b is formed flat.
As shown in FIG. 6, the heat sealing process includes the outer peripheral surface of the fixing target member 12 (17) and both sides thereof in a state where the sheets 2 a and 2 b constituting the fixing target member attaching portions 7 and 8 are compressed (narrow pressure). This is done by pressing and heating the sheets 2a, 2b located in the position. In the heat sealing process of this embodiment, as shown in FIGS. 1 and 4 to 8, a heat seal 19 is applied to the peripheral side of the soft bag 2 from the portion compressed in the compression process. The sheet 2a against the pressure of the heat sealing mold generated on both sides of the fixing target member sandwiching the fixing target member by performing the compression and heat sealing on the fixing target member and the fixing target member in such a positional relationship. , 2b can be eliminated in advance. In addition, since the compression and the heat sealing are performed in such a positional relationship, a pinhole is formed at the drug chamber side end portion (the portion in contact with the drug solution in the drug chamber) of the heat seal 19 formed by the sealing mold 26. It can be surely prevented from occurring.

なお、シール用金型２６は、本発明の実施例のような形状に限定されず、固定対象部材１２（１７）を軟質バッグ２の固定対象部材取付部７，８に融着可能なものであればいかなる形状であってもよい。本発明の実施例のシール用金型２６は、上述した圧迫部２２によりシートを圧迫した状態において、固定対象部材１２（１７）を軟質バッグ２にヒートシール１９するためのシール用金型２６である。
シール用金型の材質としては、熱伝導性が高いものが用いられ、銅、銅合金、ベリリウム鋼、アルミ、アルミ合金、亜鉛合金、ステンレス鋼等が用いられる。
ヒートシールは、上述したように狭圧部２２により固定対象部材１２（１７）の両側および固定対象部材１２（１７）の外周面のシートを狭圧した状態で、シール用金型２６により固定対象部材１２（１７）に対して固着することにより行われる。 The sealing mold 26 is not limited to the shape as in the embodiment of the present invention, and can fix the fixing target member 12 (17) to the fixing target member attaching portions 7 and 8 of the soft bag 2. Any shape is acceptable. The sealing mold 26 according to the embodiment of the present invention is a sealing mold 26 for heat-sealing the fixing target member 12 (17) to the soft bag 2 in a state where the sheet is pressed by the above-described pressing portion 22. is there.
As the material of the sealing mold, a material having high thermal conductivity is used, and copper, copper alloy, beryllium steel, aluminum, aluminum alloy, zinc alloy, stainless steel and the like are used.
As described above, heat sealing is performed by the sealing mold 26 in a state where the narrow pressure portion 22 narrows the sheets on both sides of the fixing target member 12 (17) and the outer peripheral surface of the fixing target member 12 (17). This is performed by being fixed to the member 12 (17).

本発明の実施例の第１の金型２８及び第２の金型２９でヒートシールすることにより、排出ポート１２、薬剤容器取付用部材１７が軟質バッグ２の固定対象部材取付部７，８に液密に取り付けられる。上述したシール用金型２６によるヒートシールにより、排出ポート１２，薬剤容器１３，薬剤容器取付用部材１７の外周面及びその両側部分には帯状のシール部１９が形成される。
ヒートシールする際のシール用金型２６の温度は、軟質バッグ２の形成材料の溶融温度より５℃以上高いものとして行うことが好ましく、特に、１０〜３０℃高いものとすることが好ましい。また、軟質バッグ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５℃以上高いものとすることが好ましく、特に、３０〜８０℃高いものとすることが好ましい。また、シール工程におけるシール圧は、軟質バッグ２の形成材料等によっても相違するが、１５〜１００ｋｇ／ｃｍ2であるのが好ましく、３０〜８０ｋｇ／ｃｍ2であることがより好ましい。
本発明のようにヒートシール工程を行うことにより、ヒートシールした際に固定対象部材１２（１７）の外周面若しくは両側に位置するシートが肉薄になりにくくなる。 By heat-sealing with the first mold 28 and the second mold 29 of the embodiment of the present invention, the discharge port 12 and the drug container mounting member 17 are attached to the fixing target member mounting portions 7 and 8 of the flexible bag 2. Mounted liquid-tight. By the heat sealing by the sealing mold 26 described above, the band-shaped seal portions 19 are formed on the outer peripheral surface of the discharge port 12, the drug container 13, and the drug container mounting member 17 and on both sides thereof.
The temperature of the sealing mold 26 at the time of heat sealing is preferably 5 ° C. or more higher than the melting temperature of the forming material of the soft bag 2, and particularly preferably 10 to 30 ° C. higher. Moreover, when the soft bag 2 is formed with a laminated body, it is preferably 5 ° C. or more higher than the melting temperature of the forming material forming the inner layer, and particularly 30 to 80 ° C. higher. Is preferred. Further, sealing pressure on the seal step, which varies depending on the material for forming the soft bag 2 or the like, is preferably from 15~100kg / cm 2, more preferably 30~80kg / cm 2.
By performing the heat sealing step as in the present invention, the sheets located on the outer peripheral surface or both sides of the fixing target member 12 (17) are less likely to become thin when heat sealing is performed.

次に、ヒートシール工程後、ヒートシールされた部分１９を冷却する冷却工程を行うものであることが好ましい。冷却工程は、ヒートシールされた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、冷却工程は、圧迫工程によるシート同士の圧迫を保持した状態で行われるものであることが好ましい。本発明の実施例では、図７に示すように、シール用金型２６を解除して、シート狭圧部２２により固定対象部材１２（１７）の外周面若しくは両側を圧迫した状態で冷却工程が行われる。このように冷却工程を行うことにより固定対象部材１２（１７）の外周面もしくは両側に位置するシートが肉薄になりにくくなる。そして、冷却工程後、図８に示すように、挟圧部の挟持状態を解除する。
そして、軟質バッグ２の内部空間内に薬液に注入して、必要に応じて、ポート１２の筒状部材１２ａ、薬剤容器１３を取り付け、本発明の医療用容器の製造が完了する。
また、本発明は、上記製造方法により製造される医療用容器１である。この医療用容器１は、上記の製造方法により製造されるため、固定対象部材１２（１７）の外周面もしくは両側に位置するシート２ａ，２ｂが肉薄になっていない。 Next, it is preferable to perform a cooling step for cooling the heat-sealed portion 19 after the heat sealing step. The cooling step is preferably performed by applying cold air to the heat-sealed portion. Moreover, it is preferable that a cooling process is performed in the state hold | maintained the compression of the sheets by a compression process. In the embodiment of the present invention, as shown in FIG. 7, the cooling process is performed in a state where the sealing mold 26 is released and the outer peripheral surface or both sides of the fixing target member 12 (17) are pressed by the sheet narrow pressure portion 22. Done. By performing the cooling step in this manner, the sheets positioned on the outer peripheral surface or both sides of the fixing target member 12 (17) are less likely to become thin. And after a cooling process, as shown in FIG. 8, the clamping state of a clamping part is cancelled | released.
And it inject | pours into a chemical | medical solution in the internal space of the soft bag 2, and the cylindrical member 12a of the port 12 and the chemical | medical agent container 13 are attached as needed, and manufacture of the medical container of this invention is completed.
Moreover, this invention is the medical container 1 manufactured by the said manufacturing method. Since the medical container 1 is manufactured by the above manufacturing method, the sheets 2a and 2b located on the outer peripheral surface or both sides of the fixing target member 12 (17) are not thin.

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に示す医療用容器を構成する軟質バッグの正面図である。FIG. 2 is a front view of the soft bag constituting the medical container shown in FIG. 図３は、本発明の一実施例のヒートシール用装置の斜視図である。FIG. 3 is a perspective view of a heat sealing apparatus according to an embodiment of the present invention. 図４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（圧迫工程前）。Drawing 4 is an explanatory view for explaining the example of the manufacturing method of the medical container of the present invention (before a compression process). 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説明図である（圧迫工程）。FIG. 5 is an explanatory view for explaining an embodiment of the method for producing a medical container of the present invention (compression step). 図６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（ヒートシール工程）。FIG. 6 is an explanatory diagram for explaining an embodiment of the method for producing a medical container of the present invention (heat sealing step). 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（シール用金型解除）。FIG. 7 is an explanatory view for explaining an embodiment of the method for producing a medical container of the present invention (sealing mold release). 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（圧迫解除）。FIG. 8 is an explanatory diagram for explaining an embodiment of the method for producing a medical container of the present invention (pressure release). 図９は、本発明の医療用容器の製造方法の実施例の圧迫工程を説明するための説明図（圧迫される部分における断面図）である。FIG. 9 is an explanatory diagram (a cross-sectional view of a portion to be compressed) for explaining a compression process in an embodiment of the method for manufacturing a medical container of the present invention. 図１０は、本発明の医療用容器の製造方法の実施例の圧迫工程を説明するための説明図である（圧迫される部分における断面図）である。FIG. 10 is an explanatory diagram for explaining the compression process of the embodiment of the method for manufacturing a medical container of the present invention (a cross-sectional view of a portion to be compressed). 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。FIG. 11 is explanatory drawing for demonstrating the Example of the manufacturing method of the medical container of this invention. 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.

符号の説明Explanation of symbols

１ 医療用容器
２ 軟質バッグ
２ａ，２ｂ 軟質樹脂製シート
７，８ 固定対象部材取付部
１２ ポート
１７ 薬剤容器取付用部材
１８ 固定対象部材の外周面付近
１９ バッグ周縁側の固定対象部材取付部付近 DESCRIPTION OF SYMBOLS 1 Medical container 2 Soft bag 2a, 2b Soft resin sheet | seat 7,8 Fixing target member attaching part 12 Port 17 Drug container attaching member 18 Periphery surface vicinity of fixing target member 19 Bag near fixing target member attaching part

Claims (8)

薬剤室を有する軟質バッグと、一端が該薬剤室に露出するように該軟質バッグに取り付けられた硬質固定対象部材とを有する医療用容器の製造方法であって、該製造方法は、前記軟質バッグの一端部には一端側シール部を有し、他端部には他端側シール部を有し、かつ、前記一端側シール部に該一端側シール部の一部をシールしないことにより形成された固定対象部材取付部を有する軟質樹脂製シートにより構成された軟質バッグと、前記固定対象部材とを準備する工程と、前記固定対象部材を前記軟質バッグの前記一端側シール部の一部をシールしないことにより形成された固定対象部材取付部に配置する配置工程と、前記配置工程により配置された前記固定対象部材の外周面付近を前記軟質バッグの両面側から圧迫して該固定対象部材取付部を構成するシート同士を近接もしくは接触させる固定対象部材取付部圧迫工程と、該圧迫工程による圧迫を維持した状態で圧迫された部分よりも軟質バッグ周縁側の固定対象部材取付部付近にシール用金型を押し当てることにより前記固定対象部材を前記軟質バッグにヒートシールにより固着するヒートシール工程と、前記圧迫工程によるシート同士の圧迫を保持した状態かつ、前記シール用金型を前記軟質バッグ周縁側の固定対象部材取付部より離間させた後、前記ヒートシールされた部分を冷却する冷却工程とを備えることを特徴とする医療用容器の製造方法。 A soft bag having a drug chamber, methods of making a medical container having one end and a rigid fixed object member which is attached to the soft quality bag so as to be exposed to the drug chamber, the manufacturing method, the soft bag The one end portion has a one end side seal portion, the other end portion has the other end side seal portion, and a portion of the one end side seal portion is not sealed to the one end side seal portion. A step of preparing a soft bag made of a soft resin sheet having a fixing target member mounting portion and the fixing target member, and sealing the fixing target member with a part of the one end side seal portion of the soft bag an arrangement step of arranging the fixed target member mounting portion formed by not, collected the fixing subject member by compressing the vicinity of the outer peripheral surface of the fixed target member disposed by the disposing step from both sides of the soft bag A fixed target member mounting portion compression step of proximity or contact sheets that constitute the section, sealing around the fixed target member mounting portion of the flexible bag peripheral side from portions pressure while maintaining the pressure by the compression step a heat seal affixing by heat sealing the fixing target member to the flexible bag by pressing the mold, the state and maintaining the pressure between the sheets due to the compression step, the soft bag peripheral said sealing die And a cooling step of cooling the heat-sealed portion after being separated from the fixing target member mounting portion on the edge side . 前記固定対象部材取付部圧迫工程は、前記固定対象部材の外周面部分及び該固定対象部材の両側部分を前記軟質バッグの両面側から圧迫するものである請求項１に記載の医療用容器の製造方法。 2. The manufacturing of the medical container according to claim 1, wherein the fixing target member attaching portion pressing step presses an outer peripheral surface portion of the fixing target member and both side portions of the fixing target member from both sides of the soft bag. Method. 前記冷却工程は、冷風をあてることにより行うものである請求項１または２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 or 2, wherein the cooling step is performed by applying cold air . 前記固定対象部材取付部は、前記軟質バッグの内部空間側から前記の外縁に向かって拡径している請求項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 fixing target member attachment portion has a diameter that increases from the inner space side of the soft bag toward the outer edge. 前記固定対象部材は、排出ポート及び／若しくは混注ポート、又は、排出ポート及び／若しくは薬剤容器、薬剤容器取付用部材である請求項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, wherein the fixing target member is a discharge port and / or a mixed injection port, or a discharge port and / or a drug container or a drug container mounting member. 前記固定対象部材取付部圧迫工程は、前記固定対象部材の外周面付近を前記軟質バッグの両面側から圧迫して該固定対象部材取付部を構成するシート同士を近接もしくは接触させるためのシート圧迫部を用いて行うものであり、かつ、前記圧迫部には、耐熱性硬質プラスチックを用いるものである請求項１に記載の医療用容器の製造方法。In the fixing target member attaching portion pressing step, a sheet pressing portion for pressing the vicinity of the outer peripheral surface of the fixing target member from both sides of the soft bag so that the sheets constituting the fixing target member attaching portion are brought close to or in contact with each other. The method for producing a medical container according to claim 1, wherein a heat-resistant hard plastic is used for the compression portion. 前記耐熱性硬質プラスチックは、ポリエーテルエーテルケトンあるいはポリエーテルエーテルケトンのガラスもしくはカーボン強化品である請求項６に記載の医療用容器の製造方法。The method for producing a medical container according to claim 6, wherein the heat-resistant hard plastic is polyetheretherketone or polyetheretherketone glass or carbon reinforced product. 前記固定対象部材取付部圧迫工程は、前記固定対象部材の外周面付近を前記軟質バッグの両面側から圧迫して該固定対象部材取付部を構成するシート同士を近接もしくは接触させるためのシート圧迫部を用いて行うものであり、かつ、前記圧迫部は、内部に冷却用パイプを有するものである請求項１に記載の医療用容器の製造方法。In the fixing target member attaching portion pressing step, a sheet pressing portion for pressing the vicinity of the outer peripheral surface of the fixing target member from both sides of the soft bag so that the sheets constituting the fixing target member attaching portion are brought close to or in contact with each other. The method for manufacturing a medical container according to claim 1, wherein the compression portion has a cooling pipe inside.
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JP5781661B2 (en) * 2014-05-01 2015-09-24 テルモ株式会社 Manufacturing method of medical container
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