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JP2005279108A - Method for manufacturing medical receptacle, and receptacle - Google Patents

Method for manufacturing medical receptacle, and receptacle Download PDF

Info

Publication number
JP2005279108A
JP2005279108A JP2004101311A JP2004101311A JP2005279108A JP 2005279108 A JP2005279108 A JP 2005279108A JP 2004101311 A JP2004101311 A JP 2004101311A JP 2004101311 A JP2004101311 A JP 2004101311A JP 2005279108 A JP2005279108 A JP 2005279108A
Authority
JP
Japan
Prior art keywords
end side
press
cooling
side seal
sheet
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.)
Granted
Application number
JP2004101311A
Other languages
Japanese (ja)
Other versions
JP4568521B2 (en
Inventor
Kazunobu Sugiyama
和伸 杉山
Shigeaki Tomiya
滋晃 冨家
Akihiko Katsumata
晃彦 勝又
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP2004101311A priority Critical patent/JP4568521B2/en
Publication of JP2005279108A publication Critical patent/JP2005279108A/en
Application granted granted Critical
Publication of JP4568521B2 publication Critical patent/JP4568521B2/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • 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
    • B29C66/03—After-treatments in the joint area
    • B29C66/032—Mechanical after-treatments
    • B29C66/0324—Reforming or reshaping the joint, e.g. folding over
    • B29C66/03241—Flattening
    • 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
    • B29C66/03—After-treatments in the joint area
    • B29C66/034—Thermal after-treatments
    • B29C66/0342—Cooling, e.g. transporting through welding and cooling zone
    • 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
    • B29C66/135—Single hemmed joints, i.e. one of the parts to be joined being hemmed in the joint area
    • 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
    • B29C66/244—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 non-straight, e.g. forming non-closed contours
    • 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
    • B29C66/32—Measures for keeping the burr form under control; Avoiding burr formation; Shaping the burr
    • B29C66/326—Shaping the burr, e.g. by the joining tool
    • B29C66/3262—Shaping the burr, e.g. by the joining tool as after-treatment, e.g. by a separate tool
    • 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
    • B29C66/346—Making joints having variable thicknesses in the joint area, e.g. by using jaws having an adapted configuration
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/40—General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41—Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43—Joining a relatively small portion of the surface of said articles
    • B29C66/431—Joining the articles to themselves
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/739—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/7392—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic
    • B29C66/73921—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic characterised by the materials of both parts being thermoplastics
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/81—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps
    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81411—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
    • B29C66/81425—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 stepped, e.g. comprising a shoulder
    • 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
    • B29C66/81427—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 ridge, e.g. for making a weakening line; comprising a single tooth
    • 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
    • B29C66/818—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 cooling constructional aspects, or by the thermal or electrical insulating or conducting constructional aspects of the welding jaws or of the clamps ; comprising means for compensating for the thermal expansion of the welding jaws or of the clamps
    • B29C66/8181—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 cooling constructional aspects, or by the thermal or electrical insulating or conducting constructional aspects of the welding jaws or of the clamps ; comprising means for compensating for the thermal expansion of the welding jaws or of the clamps characterised by the cooling constructional aspects
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
    • B29C66/832—Reciprocating joining or pressing tools
    • B29C66/8322—Joining or pressing tools reciprocating along one axis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • 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
    • B29C66/23—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being multiple and parallel or being in the form of tessellations
    • B29C66/232—Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being multiple and parallel or being in the form of tessellations said joint lines being multiple and parallel, i.e. the joint being formed by several parallel joint lines
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53—Joining single elements to tubular articles, hollow articles or bars
    • B29C66/532—Joining single elements to the wall of tubular articles, hollow articles or bars
    • B29C66/5326—Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
    • B29C66/53261—Enclosing tubular articles between substantially flat elements
    • B29C66/53262—Enclosing spouts between the walls of bags, e.g. of medical bags
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71—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
    • 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
    • B29C66/81415—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 bevelled
    • B29C66/81419—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 bevelled and flat
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/0088—Blends of polymers
    • 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

Landscapes

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

Abstract

<P>PROBLEM TO BE SOLVED: To provide a method for manufacturing a medical receptacle for preventing a thin part or a pinhole part from being formed in sealing by the repulsion of a sheet in a folding part, and to provide its manufacturing method, and a medial receptacle manufactured by the method. <P>SOLUTION: The method for manufacturing the medical receptacle 1 comprises: a heating press process for pressing the upper and lower end parts of a soft synthetic resin-made sheet shape cylindrical body 3 with the use of a thermal mold 70, so as to form upper and lower side seal parts 5 and 6, and also, medicinal chamber forming parts 15a and 15b between the seal parts 5 and 6; and a cooling press process for cooling the upper and lower end side seal parts 5 and 6. In the cooling process, cooling is performed with a cooling mold 90 concerning the lower and upper end parts 58a and 68a respectively on both sides of swelling parts 58 and 68 which are formed near boundary parts respectively between the upper and lower side seal parts 5 and 6, and the medicinal chamber forming parts 15a and 15b in the heating press process. Cooling is also performed not to completely pressurize the swelling parts 58a and 68a. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

本発明は、医療用容器の製造方法および医療用容器に関する。   The present invention relates to a method for manufacturing a medical container and a medical container.

輸液バッグ等の医療用容器としては、軟質樹脂製シートにより構成されたシート状の筒状体の上下開口端を熱融着し、内部に薬剤を充填したものが広く用いられている。この熱融着は、一般に、シート状筒状体の開口端を、熱金型で加熱プレスした後、加熱プレスにより形成された溶融状態のシール部を冷却金型によりプレスすることにより行われる。
しかし、シート状筒状体を熱金型により加熱プレスした際、筒状体の折り返し部付近に多量の空気が残存することがある。この状態で冷却金型によりプレスすると、残存空気が溶融状態のシール部側に押し出され、シール部内部に気泡が形成され、これが潰れるとピンホールが生じるおそれがある。ピンホールが存在すると、医療用容器の気密性が損なわれ、例えば、空気中の水分、酸素、二酸化炭素などが容器内に侵入し、薬剤を変質させるおそれがある。特に、薬剤室のシール際にピンホールが発生すると、液漏れ、薬剤の変質等の影響が大きい。 As medical containers such as infusion bags, those in which the upper and lower openings of a sheet-like cylindrical body made of a soft resin sheet are heat-sealed and filled with a medicine are widely used. This heat fusion is generally performed by pressing the open end of the sheet-like cylindrical body with a hot mold and then pressing the melted seal portion formed by the hot press with a cooling mold.
However, when the sheet-like cylindrical body is heated and pressed with a hot mold, a large amount of air may remain near the folded portion of the cylindrical body. If the cooling mold is pressed in this state, the residual air is pushed out to the melted seal portion side, and bubbles are formed inside the seal portion. When pinholes are present, the airtightness of the medical container is impaired. For example, moisture, oxygen, carbon dioxide, etc. in the air may enter the container and alter the drug. In particular, if a pinhole is generated when the drug chamber is sealed, the influence of liquid leakage, drug alteration, and the like is great.

そこで、本件出願人は、特開２００１−２０４７９２号（特許文献１）に示すものを提案している。
特許文献１には、チューブ状に形成され、折り返し部を有するシート材で構成され、前記シート材をヒートシールすることによって形成されたバッグの内部に液体が収納された医療用容器の製造方法であって、前記シート材の前記折り返し部の少なくとも一部を含む領域を予備シールして予備シール部を形成し、次いで、前記予備シール部よりシール強度が大きく、かつ前記折り返し部において前記予備シール部と重なるように再びシールしてシール部を形成し、その後、前記バッグ内部に前記液体を注入することを特徴とする医療用容器の製造方法が提案されている。この製造方法の目的は、シール部における気泡、ピンホール等の欠陥の発生を防止することである。
上記のものもシール部における気泡、ピンホール等の発生を十分に防止するが、より高いピンホール発生の防止が望まれている。
特開２００１−２０４７９２号公報 Therefore, the applicant of the present application has proposed one disclosed in Japanese Patent Application Laid-Open No. 2001-204792 (Patent Document 1).
Patent Document 1 discloses a method for manufacturing a medical container that is formed in a tube shape and is configured by a sheet material having a folded portion, and in which a liquid is stored in a bag formed by heat-sealing the sheet material. A preliminary seal portion is formed by pre-sealing a region including at least a part of the folded portion of the sheet material, and then the seal strength is larger than that of the preliminary seal portion, and the preliminary seal portion in the folded portion. A method of manufacturing a medical container has been proposed, in which a sealing portion is formed by sealing again so as to overlap, and then the liquid is injected into the bag. The purpose of this manufacturing method is to prevent the occurrence of defects such as bubbles and pinholes in the seal portion.
Although the above-mentioned ones sufficiently prevent the generation of bubbles, pinholes and the like in the seal portion, it is desired to prevent the occurrence of higher pinholes.
JP 2001-204792 A

そこで、本発明の目的は、曲げ反発性の強いシートにより構成された筒状体をシールした場合、折り返し部のシートの反発性によりシール際に肉薄部もしくはピンホール部が形成されることを防止する医療用容器の製造方法及びこの製造方法により製造した医療用容器を提供するものである。   Therefore, an object of the present invention is to prevent a thin portion or a pinhole portion from being formed at the time of sealing due to the resilience of the folded portion of the sheet when sealing a cylindrical body composed of a sheet having a strong bending resilience. The present invention provides a method for producing a medical container and a medical container produced by this production method.

上記目的を達成するものは、以下のものである。
（１） チューブ状に成形され、折り曲げられることにより形成された２つの側辺と、シールされた上端部及び下端部と、内部に形成された薬剤室と、該薬剤室に収容された薬剤とを備える医療用容器の製造方法であって、該医療用容器の製造方法は、軟質合成樹脂によりチューブを作製し、該チューブを折り曲げることによりシート状筒状体を準備する工程と、該シート状筒状体の上端部及び下端部を熱金型によりプレスして上端側シール部及び下端側シール部を形成し、該上端側シール部と該下端側シール部の内側に薬剤室形成部を形成する加熱プレス工程と、前記上端側シール部及び該下端側シール部を冷却金型を押し当てることにより冷却する冷却プレス工程を行うものであり、かつ、前記冷却プレス工程は、前記加熱プレス工程において前記上端側シール部と前記薬剤室形成部との境界部付近に形成された膨出部の両側下端部ならびに前記下端側シール部と前記薬剤室形成部との境界部付近に形成された膨出部の両側上端部が前記冷却金型により冷却されるとともに該膨出部を完全に押しつぶさないように行うものであることを特徴とする医療用容器の製造方法。
（２） 前記冷却プレス工程は、前記冷却金型が前記膨出部を押圧するとともに、該膨出部付近の前記薬剤室形成部を形成するシート表面に実質的に接触しないように行うものである上記（１）に記載の医療用容器の製造方法。 What achieves the above object is as follows.
(1) Two sides formed by being formed into a tube shape and bent, a sealed upper end portion and a lower end portion, a medicine chamber formed inside, and a medicine accommodated in the medicine chamber A method for producing a medical container comprising: a tube made of a soft synthetic resin, and a sheet-like cylindrical body is prepared by bending the tube; and The upper end portion and the lower end portion of the cylindrical body are pressed by a hot mold to form the upper end side seal portion and the lower end side seal portion, and the drug chamber forming portion is formed inside the upper end side seal portion and the lower end side seal portion. A heating press step, a cooling press step for cooling the upper end side seal portion and the lower end side seal portion by pressing a cooling mold, and the cooling press step is performed in the heating press step. Oh And lower end portions on both sides of the bulge portion formed near the boundary portion between the upper end side seal portion and the drug chamber forming portion, and a bulge portion formed near the boundary portion between the lower end side seal portion and the drug chamber forming portion. A method for producing a medical container, characterized in that the upper end portions on both sides of the protruding portion are cooled by the cooling mold so as not to completely crush the bulging portion.
(2) The cooling press step is performed such that the cooling mold presses the bulging portion and does not substantially contact the sheet surface forming the drug chamber forming portion in the vicinity of the bulging portion. The manufacturing method of the medical container as described in said (1).

（３） 前記冷却プレス工程では、前記上端側シール部および前記下端側シール部は、前記膨出部のプレスよりも強く冷却金型によりプレスされるものである上記（１）または（２）に記載の医療用容器の製造方法。
（４） 前記冷却プレス工程では、前記両側下端部を除く部分の前記上端側シール部側の膨出部は、前記両側下端部の膨出部のプレスと同様もしくは該プレスよりも強く冷却金型によりプレスされるものであり、前記両側上端部を除く部分の前記下端側シール部側の膨出部は、前記両側上端部の膨出部のプレスと同様もしくは該プレスよりも強く冷却金型によりプレスされるものである上記（１）ないし（３）のいずれかに記載の医療用容器の製造方法。
（５） 前記加熱プレス工程は、前記上端側シール部及び下端側シール部の内縁が前記側辺に向かうに従って向かい合う他端に近づく形態となるように行うものである上記（１）ないし（４）のいずれかに記載の医療用容器の製造方法。 (3) In said cooling press process, said upper end side seal part and said lower end side seal part are pressed by a cooling die more strongly than the press of said bulging part to said (1) or (2). The manufacturing method of the medical container as described.
(4) In the cooling press step, the bulging portion on the upper end side seal portion side of the portion excluding the lower end portions on both sides is the same as or stronger than the press of the bulging portion on the lower end portions on both sides. The bulging portion on the lower seal portion side of the portion excluding the upper end portions on both sides is the same as the press on the bulging portion on the upper end portions on both sides or stronger than the press by a cooling mold. The method for producing a medical container according to any one of (1) to (3), wherein the medical container is pressed.
(5) The said heat press process is performed so that it may become the form which approaches the other end which faces the inner edge of the said upper end side seal part and a lower end side seal part toward the said side, and approaches (4). The manufacturing method of the medical container in any one of.

（６） 前記冷却プレス工程に使用される冷却金型は、前記上端側シール部及び下端側シール部をプレスするメインプレス面と、前記膨出部をプレスする膨出部プレス面と、前記薬剤室形成部上に配置される非プレス面とを備えている上記（１）ないし（５）のいずれかに記載の医療用容器の製造方法。
（７） 前記冷却金型における前記膨出部プレス面と前記メインプレス面間の段差は、０．２５〜０．３５mmである上記（６）に記載の医療用容器の製造方法。
（８） 前記冷却金型における前記膨出部プレス面と前記メインプレス面間の段差は、前記シート状筒状体のシート厚みをｔに対して、０．７６ｔ〜１．１ｔの範囲内である上記（６）または（７）に記載の医療用容器の製造方法。 (6) The cooling mold used in the cooling press step includes a main press surface that presses the upper end side seal portion and the lower end side seal portion, a bulge portion press surface that presses the bulge portion, and the medicine. A method for producing a medical container according to any one of (1) to (5), further comprising a non-pressing surface disposed on the chamber forming portion.
(7) The manufacturing method of the medical container according to (6), wherein a step between the bulging portion press surface and the main press surface in the cooling mold is 0.25 to 0.35 mm.
(8) The step between the bulging portion press surface and the main press surface in the cooling mold is within a range of 0.76 t to 1.1 t with respect to the sheet thickness of the sheet-like cylindrical body t. A method for producing a medical container according to (6) or (7) above.

（９） 前記加熱プレス工程および前記冷却プレス工程は、前記シート状筒状体の加熱プレス工程および冷却プレス工程後のシール部分の厚さが、前記シート状筒状体におけるシート１枚の厚さｔに対して、１．２ｔ〜１．５ｔの範囲内となり、前記上端側シール部及び下端側シール部の両側部と前記薬剤室形成部との境界部における厚さが、１．９６ｔ〜２．６ｔとなるように行うものである上記（１）ないし（８）のいずれかに記載の医療用容器の製造方法。
（１０） 前記シート状筒状体は、インフレーション成形によってチューブ状に成形されたものである上記（１）ないし（８）のいずれかに記載の医療用容器の製造方法。
（１１） 前記製造方法は、前記薬剤室形成部を仕切る仕切用シール形成工程を有している上記（１）ないし（１０）のいずれかに記載の医療用容器の製造方法。
（１２） 上記（１）ないし（１１）のいずれかに記載の医療用容器の製造方法により製造されたことを特徴とする医療用容器。 (9) In the heating press step and the cooling press step, the thickness of the seal portion after the heating press step and the cooling press step of the sheet-like cylindrical body is the thickness of one sheet in the sheet-like cylindrical body. With respect to t, the thickness is in the range of 1.2 t to 1.5 t, and the thickness at the boundary between the both sides of the upper end side seal portion and the lower end side seal portion and the drug chamber forming portion is 1.96 t to 2 The method for producing a medical container according to any one of the above (1) to (8), which is performed so as to be 6 t.
(10) The method for manufacturing a medical container according to any one of (1) to (8), wherein the sheet-like cylindrical body is formed into a tube shape by inflation molding.
(11) The said manufacturing method is a manufacturing method of the medical container in any one of said (1) thru | or (10) which has the partition seal | sticker formation process which partitions off the said chemical | medical agent chamber formation part.
(12) A medical container manufactured by the method for manufacturing a medical container according to any one of (1) to (11).

本発明の医療用容器の製造方法は、チューブ状に成形され、折り曲げられることにより形成された２つの側辺と、シールされた上端部及び下端部と、内部に形成された薬剤室と、該薬剤室に収容された薬剤とを備える医療用容器の製造方法であって、該医療用容器の製造方法は、軟質合成樹脂によりチューブを作製し、該チューブを折り曲げることによりシート状筒状体を準備する工程と、該シート状筒状体の上端部及び下端部を熱金型によりプレスして上端側シール部及び下端側シール部を形成し、該上端側シール部と該下端側シール部の内側に薬剤室形成部を形成する加熱プレス工程と、前記上端側シール部及び該下端側シール部を冷却金型を押し当てることにより冷却する冷却プレス工程を行うものであり、かつ、前記冷却プレス工程は、前記加熱プレス工程において前記上端側シール部と前記薬剤室形成部との境界部付近に形成された膨出部の両側下端部ならびに前記下端側シール部と前記薬剤室形成部との境界部付近に形成された膨出部の両側上端部が前記冷却金型により冷却されるとともに該膨出部を完全に押しつぶさないように行うものである。
このため、本発明の医療用容器の製造方法によれば、チューブ状の樹脂製シートを熱金型によりプレスした際に大量に残ったシート材の折り返し部付近の空気が、冷却金型によるプレスでシール部側（溶融プレス部側）に押し出され、ピンホール発生原因となる気泡が形成されることが無い。さらに曲げ反発性の強いシートにより構成された筒状体をシールした場合、折り返し部のシートの反発性によりシール際に肉薄部もしくはピンホール部が形成されることを防止する医療用容器を製造することができる。 The method for producing a medical container of the present invention comprises two sides formed by being formed into a tube shape and bent, a sealed upper end portion and a lower end portion, a drug chamber formed therein, A medical container manufacturing method comprising a medicine housed in a medicine chamber, wherein the medical container manufacturing method comprises producing a tube from a soft synthetic resin and bending the tube to form a sheet-like cylindrical body. A step of preparing, and an upper end portion and a lower end portion of the sheet-like cylindrical body are pressed by a hot mold to form an upper end side seal portion and a lower end side seal portion, and the upper end side seal portion and the lower end side seal portion A heating press step for forming a drug chamber forming portion on the inside, and a cooling press step for cooling the upper end side seal portion and the lower end side seal portion by pressing a cooling mold, and the cooling press Process In the heating and pressing step, both lower ends on both sides of the bulging portion formed in the vicinity of the boundary portion between the upper end side seal portion and the drug chamber forming portion, and the vicinity of the boundary portion between the lower end side seal portion and the drug chamber forming portion The upper end portions on both sides of the bulging portion formed in the above are cooled by the cooling mold, and the bulging portion is not completely crushed.
For this reason, according to the method for manufacturing a medical container of the present invention, when a tube-shaped resin sheet is pressed by a hot die, a large amount of air in the vicinity of the folded portion of the sheet material is pressed by the cooling die. Thus, no air bubbles are formed which are pushed out to the seal part side (melting press part side) and cause pinholes. Further, when a cylindrical body constituted by a sheet having a strong bending resilience is sealed, a medical container that prevents a thin portion or a pinhole portion from being formed at the time of sealing due to the resilience of the folded portion sheet is manufactured. be able to.

また、前記冷却プレス工程が、前記冷却金型が前記膨出部を押圧するとともに、該膨出部付近の前記薬剤室形成部を形成するシート表面に実質的に接触しないように行うものであれば、チューブ内残存空気の押し出しによるピンホール部発生及び折り返し部のシートの反発性によりシール際に肉薄部もしくはピンホール部の形成をより確実に防止することができる。
また、前記冷却プレス工程において、前記両側下端部を除く部分の前記上端側シール部側の膨出部は、前記両側下端部の膨出部のプレスと同様もしくは該プレスよりも強く冷却金型によりプレスされるものであり、前記両側上端部を除く部分の前記下端側シール部側の膨出部は、前記両側上端部の膨出部のプレスと同様もしくは該プレスよりも強く冷却金型によりプレスされるものであれば、加熱プレス工程において形成される膨出部全体におけるシール際の肉薄部もしくはピンホール部の形成をより確実に防止する。 Further, the cooling press step is performed so that the cooling mold presses the bulging portion and does not substantially contact the surface of the sheet forming the drug chamber forming portion near the bulging portion. For example, it is possible to more reliably prevent the formation of a thin portion or a pinhole portion at the time of sealing due to the generation of the pinhole portion due to the extrusion of the residual air in the tube and the resilience of the sheet of the folded portion.
Further, in the cooling press step, the bulging portion on the upper end side seal portion side of the portion excluding the lower end portions on both sides is the same as the pressing of the bulging portion on the lower end portions on both sides or stronger than the press by a cooling mold. The bulging portion on the lower end seal portion side of the portion excluding the upper end portions on both sides is pressed by a cooling mold in the same manner as the bulging portion on the upper end portions on both sides or stronger than the press. If it is done, formation of the thin part or pinhole part at the time of sealing in the whole bulging part formed in a heat press process is prevented more reliably.

また、前記冷却プレス工程に使用される冷却金型が、前記上端側シール部及び下端側シール部をプレスするメインプレス面と、前記膨出部をプレスする膨出部プレス面と、前記薬剤室形成部上に配置される非プレス面とを備えているものであれば、上記の冷却プレス工程を容易かつ確実に行うことができる。
本発明の医療用容器は、上記医療用容器の製造方法により製造されている。
このため、本発明の医療用容器は、曲げ反発性の強いシートにより構成された筒状体をシールすることにより製造された場合であっても、筒状体の折り返し部に肉薄部もしくはピンホール部を持たないものとなり、液漏れのない良好な医療用容器である。 The cooling mold used in the cooling press step includes a main press surface that presses the upper end side seal portion and the lower end side seal portion, a bulge portion press surface that presses the bulge portion, and the chemical chamber. If it has the non-pressing surface arrange | positioned on a formation part, said cooling press process can be performed easily and reliably.
The medical container of this invention is manufactured by the manufacturing method of the said medical container.
For this reason, even if the medical container of the present invention is manufactured by sealing a cylindrical body composed of a sheet having strong bending resilience, a thin portion or a pinhole is formed at the folded portion of the cylindrical body. It is a good medical container that does not have a part and does not leak.

本発明の医療用容器の製造方法および医療用容器について詳細に説明する。
図１は、本発明の医療用容器の一実施例の正面図である。
本発明の医療用容器１の製造方法は、チューブ状に成形され、折り曲げられることにより形成された２つの側辺７，８と、シールされた上端部及び下端部と、内部に形成された薬剤室１５ａ，１５ｂと、薬剤室１５ａ，１５ｂに収容された薬剤１６，１７とを備える医療用容器の製造方法であって、医療用容器１の製造方法は、軟質合成樹脂によりチューブを作製し、チューブを折り曲げることによりシート状筒状体３を準備する工程と、シート状筒状体３の上端部及び下端部を熱金型７０によりプレスして上端側シール部５及び下端側シール部６を形成し、上端側シール部５と下端側シール部６の内側に薬剤室形成部１５ａ，１５ｂを形成する加熱プレス工程と、上端側シール部５及び下端側シール部６を冷却する冷却プレス工程を行うものである。そして、冷却プレス工程では、加熱プレス工程において上端側シール部５と薬剤室形成部１５ａとの境界部付近に形成された膨出部５８の両側下端部５８ａ，５８ｂならびに下端側シール部６と薬剤室形成部１５ｂとの境界部付近に形成された膨出部６８の両側上端部６８ａ，６８ｂが、冷却金型９０により冷却されるとともに、膨出部５８ａ，５８ｂ，６８ａ，６８ｂを完全に押しつぶさないように行われる。 The method for producing a medical container and the medical container of the present invention will be described in detail.
FIG. 1 is a front view of an embodiment of the medical container of the present invention.
The manufacturing method of the medical container 1 of the present invention includes two side edges 7 and 8 formed by being formed into a tube shape and bent, a sealed upper end portion and a lower end portion, and a drug formed inside. Chambers 15a and 15b, and medicines 16 and 17 accommodated in medicines chambers 15a and 15b. The method for producing medical container 1 includes a tube made of a soft synthetic resin, The step of preparing the sheet-like tubular body 3 by bending the tube, and the upper end portion and the lower end portion of the sheet-like tubular body 3 are pressed by the hot mold 70 to thereby form the upper end side seal portion 5 and the lower end side seal portion 6. A heating press step for forming and forming the drug chamber forming portions 15a and 15b inside the upper end side seal portion 5 and the lower end side seal portion 6, and a cooling press step for cooling the upper end side seal portion 5 and the lower end side seal portion 6. Do too It is. In the cooling press step, both lower ends 58a and 58b of the bulging portion 58 formed in the vicinity of the boundary between the upper end side seal portion 5 and the drug chamber forming portion 15a and the lower end side seal portion 6 and the drug in the heat press step. The upper end portions 68a and 68b on both sides of the bulging portion 68 formed near the boundary with the chamber forming portion 15b are cooled by the cooling mold 90, and the bulging portions 58a, 58b, 68a and 68b are completely crushed. To be done.

また、本発明の医療用容器は、上記の製造方法により製造されたものである。
本発明の実施例の医療用容器１は、図１に示すように、シート状筒状体３により構成され、上端部に形成された上端側シール部５と下端部に形成された下端側シール部６と、内部に形成された薬剤室１５ａと薬剤室１５ｂと、薬剤室１５ａ，１５ｂに収容された薬剤１６，１７からなる軟質バッグ２と、軟質バッグ２の上端部及び下端部に取りつけられた排出ポート２１，２２を備えている。
医療用容器１の製造方法としては、まず、軟質合成樹脂材料によりチューブを成形し、このチューブを折り曲げ平らにすることによりシート状筒状体３を作製する。折り曲げは、合成樹脂製のチューブを軽くプレスすることにより行ってもよい。折り曲げることにより、シート状筒状体３には２つの側辺７，８が形成される。
シート状筒状体３を構成するチューブは、インフレーション成形により筒状に成形されたものが好ましい。また、チューブは、例えば、ブロー成形法、共押出インフレーション法などの種々の方法により製造されたものでもよい。 Moreover, the medical container of this invention is manufactured by said manufacturing method.
As shown in FIG. 1, the medical container 1 according to the embodiment of the present invention is configured by a sheet-like cylindrical body 3, and an upper end side seal portion 5 formed at the upper end portion and a lower end side seal formed at the lower end portion. Attached to the upper end portion and the lower end portion of the soft bag 2, the soft bag 2 including the medicine chambers 15 a and the medicine chamber 15 b formed inside, the medicines 16 and 17 accommodated in the medicine chambers 15 a and 15 b. The exhaust ports 21 and 22 are provided.
As a manufacturing method of the medical container 1, first, a tube is formed from a soft synthetic resin material, and the tube-like body 3 is produced by bending and flattening the tube. The bending may be performed by lightly pressing a synthetic resin tube. By bending, two side edges 7 and 8 are formed in the sheet-like cylindrical body 3.
The tube constituting the sheet-like cylindrical body 3 is preferably one that is formed into a cylindrical shape by inflation molding. The tube may be manufactured by various methods such as a blow molding method and a coextrusion inflation method.

シート筒状体３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、水蒸気等過度が、５０ｇ／ｍ２・２４ｈｒｓ・４０℃・９０％ＲＨ以下であることが好ましく、より好ましくは１０ｇ／ｍ２・２４ｈｒｓ・４０℃・９０％ＲＨ以下であり、さらに好ましくは１ｇ／ｍ２・２４ｈｒｓ・４０℃・９０％ＲＨ以下である。この水蒸気透過度は、ＪＩＳＫ７１２９（Ａ法）に記載の方法により測定される。このようにシート筒状体３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、充填される薬剤１６，１７の減少、濃縮を防止することができる。また、医療用容器１の外部からの水蒸気の侵入も防止することができる。
シート状筒状体３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。 The sheet cylindrical body 3 preferably has a water vapor barrier property. As the degree of water vapor barrier property, excess water vapor is preferably 50 g / m 2 · 24 hrs · 40 ° C. · 90% RH or less, more preferably 10 g / m 2 · 24 hrs · 40 ° C. · 90% RH or less. More preferably, it is 1 g / m 2 · 24 hrs · 40 ° C. · 90% RH or less. This water vapor permeability is measured by the method described in JISK7129 (Method A). Thus, when the sheet | seat cylindrical body 3 has water vapor | steam barrier property, the evaporation of the water | moisture content from the inside of the medical container 1 can be prevented. As a result, it is possible to prevent reduction and concentration of the medicines 16 and 17 to be filled. Moreover, the invasion of water vapor from the outside of the medical container 1 can be prevented.
Examples of the material for forming the sheet-like cylindrical body 3 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. And it is preferable that the resin material to be used has the heat resistance and water resistance which can endure high pressure steam sterilization (autoclave sterilization).

また、シート状筒状体３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、シート状筒状体３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。シート状筒状体３の形成材料として、特に好ましいものとして、ポリエチレンまたはポリプロピレンに、スチレン−ブタジエン共重合体やスチレン−エチレン−ブチレン−スチレンブロック共重合体等のスチレン系熱可塑性エラストマーあるいはエチレン−プロピレン共重合体やエチレン−ブテン共重合体，プロピレン−αオレフィン共重合体等のオレフィン系熱可塑性エラストマーをブレンドし柔軟化した軟質樹脂を挙げることができる。この材料は、高強度で柔軟性に富み、耐熱性（特に滅菌時の耐熱性）、耐水性が高い他、加工性が特に優れ、製造コストの低減を図ることができる点で好ましい。   Moreover, when polyolefin is contained as a forming material of the sheet-like cylindrical body 3, the usefulness of the present invention is great. Therefore, in this invention, it is preferable that polyolefin is included as a forming material of the sheet-like cylinder 3. As a material for forming the sheet-like cylindrical body 3, particularly preferable are polyethylene, polypropylene, styrene-based thermoplastic elastomers such as styrene-butadiene copolymer and styrene-ethylene-butylene-styrene block copolymer, or ethylene-propylene. A soft resin obtained by blending and softening an olefin-based thermoplastic elastomer such as a copolymer, an ethylene-butene copolymer, or a propylene-α-olefin copolymer can be given. This material is preferable in that it has high strength and flexibility, heat resistance (particularly heat resistance during sterilization) and water resistance, and is particularly excellent in workability and can reduce manufacturing costs.

シート状筒状体３を構成するシート材は、上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、シート状筒状体２のガスバリヤー性等を向上させることができる。例えば、アルミ箔等のフィルムが積層された場合、ガスバリヤー性の向上とともに、遮光性を付与したりすることができる。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、軟質バッグ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。
シート状筒状体３を構成するシート材（単層または多層積層体、図２および図３参照）３ａ，３ｂ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、２００〜３６０μｍ程度であるのがより好ましい。 The sheet material constituting the sheet-like cylindrical body 3 may have a single-layer structure (single-layer body) made of the material as described above, or a plurality of layers (particularly different materials) for various purposes. It may be a multi-layer laminate in which the above layers are stacked. 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 of the sheet-like cylindrical body 2 etc. can be improved. For example, when a film such as an aluminum foil is laminated, the gas barrier property can be improved and the light shielding property can be imparted. In addition, when a layer made of an oxide such as titanium oxide, aluminum oxide, or silicon oxide is formed, the transparency of the flexible bag 2 can be maintained while improving the gas barrier property, and the internal visibility can be secured. Can do. 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.
The thickness of the sheet material (single layer or multilayer laminate, see FIGS. 2 and 3) 3a and 3b constituting the sheet-like cylindrical body 3 depends on the layer configuration and the characteristics of the material used (flexibility, strength, water vapor transmission) However, it is usually preferably about 100 to 500 μm, more preferably about 200 to 360 μm.

次に、シート状筒状体３の上端部及び下端部を熱金型７０によりプレスして上端側シール部５及び下端側シール部６を形成し、上端側シール部と下端側シール部の内側に薬剤室形成部を形成する加熱プレス工程について説明する。
図２は、本発明の医療用容器を構成する軟質バッグの加熱プレス工程後の上側部分の拡大図であり、図３は、本発明の医療用容器を構成する軟質バッグの加熱プレス工程後の下側部分の拡大図であり、図４は、図２に示す軟質バッグの右上側部分の部分拡大図であり、図５は、図３に示す軟質バッグの右下側部分の部分拡大図であり、図６は、本発明の医療用容器の製造方法に使用される熱金型の説明図であり、図７は、本発明の医療用容器の製造方法に使用される熱金型の外観図であり、図８は、図７に示す熱金型の内縁部分の断面図である。 Next, the upper end portion and the lower end portion of the sheet-like cylindrical body 3 are pressed by the hot mold 70 to form the upper end side seal portion 5 and the lower end side seal portion 6, and the inner sides of the upper end side seal portion and the lower end side seal portion. Next, the heating press process for forming the drug chamber forming portion will be described.
FIG. 2 is an enlarged view of the upper part after the heat press step of the soft bag constituting the medical container of the present invention, and FIG. 3 is the view after the heat press step of the soft bag constituting the medical container of the present invention. 4 is an enlarged view of the lower portion, FIG. 4 is a partially enlarged view of the upper right portion of the soft bag shown in FIG. 2, and FIG. 5 is a partially enlarged view of the lower right portion of the soft bag shown in FIG. FIG. 6 is an explanatory view of a thermal mold used in the method for manufacturing a medical container of the present invention, and FIG. 7 is an external view of the thermal mold used in the method for manufacturing a medical container of the present invention. FIG. 8 is a cross-sectional view of the inner edge portion of the thermal mold shown in FIG.

加熱プレス工程は、図６，図７，図８に示すような金型７０，８０を用いて行われる。加熱プレス工程に使用される金型は、シート状筒状体３を上側から押圧する熱金型７０と、熱金型受け台８０を備えている。
熱金型７０の表面に設けられたシート状筒状体３の上端部をシールするための加熱プレス面７１と、別のシート状筒状体３の下端部をシールするための加熱プレス面７２を有している。熱金型７０は、２つのシート状筒状体３の上端部と下端部を同時にヒートシール可能なものとなっている。 The hot pressing process is performed using dies 70 and 80 as shown in FIGS. The mold used in the hot press process includes a thermal mold 70 that presses the sheet-like cylindrical body 3 from above and a thermal mold cradle 80.
A heating press surface 71 for sealing the upper end portion of the sheet-like cylindrical body 3 provided on the surface of the thermal mold 70 and a heating press surface 72 for sealing the lower end portion of another sheet-like cylindrical body 3. have. The thermal mold 70 is capable of simultaneously heat-sealing the upper end portion and the lower end portion of the two sheet-like cylindrical bodies 3.

加熱プレス面７１は、図７に示す熱金型７０の上側部分に設けられ、加熱プレス面７２は、図７に示す熱金型７０の下側部分に設けられている。加熱プレス面７１と加熱プレス面７２はほぼ平坦に作製されており、両者の高さはほぼ同じである。また、熱金型７０表面の加熱プレス面７１及び加熱プレス面７２以外の部分７５は、熱プレスしないように高さが低くなっている。このような構成により、熱プレスしたとき、シート状筒状体３の上端側シール５と下端側シール６の内側には薬剤室形成部１５ａ，１５ｂが形成される。   The heating press surface 71 is provided in the upper part of the hot die 70 shown in FIG. 7, and the heating press surface 72 is provided in the lower part of the hot die 70 shown in FIG. The heating press surface 71 and the heating press surface 72 are made substantially flat, and the heights of both are substantially the same. Further, the heating press surface 71 and the portion 75 other than the heating press surface 72 on the surface of the hot metal mold 70 are low in height so as not to be hot pressed. With such a configuration, when heat-pressed, drug chamber forming portions 15 a and 15 b are formed inside the upper end side seal 5 and the lower end side seal 6 of the sheet-like cylindrical body 3.

加熱プレス面７１は、シート状筒状体３の上端部を図２に示すような形状にヒートシール可能な形状をしており、加熱プレス面７２は、シート状筒状体３の下端部を図３に示すような形状にヒートシール可能な形状をしている。加熱プレス面７１は、シート状筒状体３の上端部の両肩にヒートシールを形成する２つの加熱プレス面７１ａ，７１ｂにより構成されている。また、加熱プレス面７２は、シート状筒状体３の下端部の両肩にヒートシールを形成する２つの加熱プレス面７２ａ，７２ｂにより構成されている。また、加熱プレス面７１ａと加熱プレス面７１ｂの間は、排出ポート取付部５１を形成するための取付部形成部７３となっている。取付部形成部７３は、プレス面７１ａとプレス面７１ｂとの間を熱プレスしないように高さが低く形成された非加熱プレス部である。同様に、シール形成部７２ａとシール形成部７２ｂの間は、排出ポート取付部６１を形成するための取付部形成部７４となっている。取付部形成部７４は、プレス面７２ａとプレス面７２ｂとの間を熱プレスしないように高さが低く形成された非加熱プレス部である。また、プレス面７１ａ，７１ｂの上端側、プレス面７２ａ，７２ｂの下端側は熱プレスしないような高さが低く形成された非加熱プレス部７５となっている。   The heating press surface 71 has a shape capable of heat-sealing the upper end portion of the sheet-like cylindrical body 3 into a shape as shown in FIG. 2, and the heating press surface 72 has a lower end portion of the sheet-like cylindrical body 3. The shape as shown in FIG. 3 is heat sealable. The heating press surface 71 is constituted by two heating press surfaces 71 a and 71 b that form a heat seal on both shoulders of the upper end portion of the sheet-like cylindrical body 3. The heating press surface 72 is constituted by two heating press surfaces 72 a and 72 b that form a heat seal on both shoulders of the lower end portion of the sheet-like cylindrical body 3. Further, a mounting portion forming portion 73 for forming the discharge port mounting portion 51 is formed between the heating press surface 71a and the heating press surface 71b. The attachment portion forming portion 73 is a non-heated press portion formed so as to have a low height so as not to be hot pressed between the press surface 71a and the press surface 71b. Similarly, a mounting portion forming portion 74 for forming the discharge port mounting portion 61 is formed between the seal forming portion 72a and the seal forming portion 72b. The attachment portion forming portion 74 is a non-heated press portion that is formed with a low height so as not to be hot pressed between the press surface 72a and the press surface 72b. Further, the upper end side of the press surfaces 71a and 71b and the lower end side of the press surfaces 72a and 72b are non-heated press portions 75 formed so as not to be hot pressed.

加熱プレス面７１及び加熱プレス面７２の両側部は、図２，図３に示すように、それぞれ上端、下端に突出する形状となっている。また、両側部は、加熱プレス面７１と加熱プレス面７２の内縁が金型の側辺に向かうにしたがって、それぞれ上端、下端に近づく形状となっている。具体的に、両側部は、外側に湾曲する形状となっている。また、加熱プレス面７１と加熱プレス面７２の両端部は、それぞれ金型７０の上端、下端に向かって徐々に細くなっている。   As shown in FIGS. 2 and 3, both side portions of the heating press surface 71 and the heating press surface 72 have shapes protruding to the upper end and the lower end, respectively. Further, the both side portions are shaped so as to approach the upper end and the lower end, respectively, as the inner edges of the heating press surface 71 and the heating press surface 72 move toward the side of the mold. Specifically, both side portions are curved outward. Further, both end portions of the heating press surface 71 and the heating press surface 72 are gradually narrowed toward the upper end and the lower end of the mold 70, respectively.

また、加熱プレス面７１の内縁部及び加熱プレス面７２の内縁部には、図６，図７，図８に示すように、その他の部分より突出した突条部もしくは段差７６，７７が形成されている。本発明の実施例では、突条部もしくは段差７６，７７は、加熱プレス面７１及び加熱プレス面７２の両側部を除いて形成されている。このような構成により、図２，図３に示すように、上端側シール部５及び下端側シール部６の内縁に沿ってその他の部分より強くシールすることができる。突条部７６，７７の断面は、図８に示すように、図７の中央側から上端、下端側に向かって傾斜部７６ａ，７７ａ、平坦部７６ｂ，７７ｂ、面取部７６ｃ，７７ｃが連続して形成されている。この実施例では、面取部７６ｃ，７７ｃは、丸みを帯びるように形成されている。面取部７６ｃ，７７ｃは、特に、Ｒ面取りされていることが好ましい。Ｒ面取りする場合の半径は、０．１〜３．０ｍｍであることが好ましい。加熱プレス面７１，７２の平坦面との突条部７６，７７の高さ（言い換えれば、加熱プレス面７１，７２の平坦面と突条部７６，７７との差）は、３０〜１００μｍであることが好ましい。傾斜部の水平方向の長さは、０．５〜２．０ｍｍであることが好ましい。なお、突条部は、連続していなくてもよい。なお、突条部もしくは段差の面取として、図９に示す糸面取部７８ｃ，７９ｃのような糸面取りであってもよい。   Further, on the inner edge portion of the heating press surface 71 and the inner edge portion of the heating press surface 72, as shown in FIGS. 6, 7, and 8, protrusions or steps 76, 77 protruding from other portions are formed. ing. In the embodiment of the present invention, the protrusions or steps 76 and 77 are formed except for both sides of the hot press surface 71 and the hot press surface 72. With such a configuration, as shown in FIGS. 2 and 3, it is possible to seal stronger than other portions along the inner edges of the upper end side seal portion 5 and the lower end side seal portion 6. As shown in FIG. 8, the protrusions 76 and 77 have a cross section in which inclined portions 76 a and 77 a, flat portions 76 b and 77 b, and chamfered portions 76 c and 77 c are continuous from the center side to the upper end and the lower end side in FIG. 7. Is formed. In this embodiment, the chamfered portions 76c and 77c are formed to be rounded. The chamfered portions 76c and 77c are particularly preferably chamfered. The radius in the case of R chamfering is preferably 0.1 to 3.0 mm. The height of the protrusions 76 and 77 with respect to the flat surface of the heating press surfaces 71 and 72 (in other words, the difference between the flat surface of the heating press surfaces 71 and 72 and the protrusions 76 and 77) is 30 to 100 μm. Preferably there is. The horizontal length of the inclined portion is preferably 0.5 to 2.0 mm. In addition, the protrusion part does not need to be continuous. Note that the chamfering of the protrusion or step may be a chamfering such as the thread chamfers 78c and 79c shown in FIG.

そして、本発明の実施例では、図７に示すように、加熱プレス面７１及び加熱プレス面７２の両側部には、突状部（もしくは段差）７８，７９が形成されている。そして、この突状部７８，７９は、図９に示すように、糸面取部７８ｃ，７９ｃを有する。突条部もしくは段差が、糸面取部７８ｃ，７９ｃを有する場合には、Ｒ面取りに比べてより強くシールすることができる。糸面取部７８ｃ，７９ｃの面取り幅は、０．１〜０．５ｍｍであることが好ましい。
受け台８０は、図６に示すように、本体部８３と、本体部８３の上面に設けられた弾性層８４からなる。本体部８３は、上面が平坦に形成されている。弾性層８４としては、ある程度の耐熱性を有する耐熱性を有する弾性材料のシートであることが好ましい。弾性層の構成材料としては、シリコーンゴム、フッ素系エラストマー等が好ましい。 In the embodiment of the present invention, as shown in FIG. 7, protrusions (or steps) 78 and 79 are formed on both sides of the hot press surface 71 and the hot press surface 72. And this protrusion part 78,79 has the thread chamfering part 78c, 79c, as shown in FIG. When the protrusion or step has the thread chamfered portions 78c and 79c, it is possible to seal more strongly than the R chamfered portion. The chamfer widths of the yarn chamfered portions 78c and 79c are preferably 0.1 to 0.5 mm.
As shown in FIG. 6, the cradle 80 includes a main body portion 83 and an elastic layer 84 provided on the upper surface of the main body portion 83. The main body 83 has a flat upper surface. The elastic layer 84 is preferably a heat-resistant elastic material sheet having a certain degree of heat resistance. As a constituent material of the elastic layer, silicone rubber, fluorine-based elastomer and the like are preferable.

上述したような金型を用いて加熱プレス工程を行う。加熱プレスは、上述したように作製したシート状筒状体３を、図６に示すように、熱金型受け台８０の表面の所定位置に配置し、上側から熱金型７０によりプレスすることにより行われる。
加熱プレス工程における熱金型７０の温度は、シート状筒状体３の形成材料の溶融温度より５５℃以上高いものとすることが好ましい。特に、７５〜１０５℃高いものとすることが好ましい。また、シート状筒状体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５５℃以上高いものとすることが好ましい。特に、７５〜１０５℃高いものとすることが好ましい。具体的な金型の温度は、筒状体３の形成材料によっても相違するが、例えば、金型温度が好ましくは１９０〜２５０℃、より好ましくは２１０〜２４０℃とすることが好ましい。また、加熱シール工程におけるシール面圧は、シート状筒状体３の形成材料等によっても相違するが、１５〜１５０Ｎ／ｃｍ２であることが好ましく、３５〜７５Ｎ／ｃｍ２であることがより好ましい。また、シール部５，６のシール強度は、２０〜６５Ｎ／１ｃｍ幅であることが好ましく、特に、３０〜６５Ｎ／１ｃｍ幅であることが好ましい。 A hot press process is performed using a mold as described above. In the heating press, the sheet-like cylindrical body 3 produced as described above is disposed at a predetermined position on the surface of the hot mold receiving base 80 as shown in FIG. Is done.
The temperature of the hot mold 70 in the hot pressing step is preferably 55 ° C. or more higher than the melting temperature of the forming material of the sheet-like cylindrical body 3. In particular, it is preferably 75 to 105 ° C. higher. Moreover, when the sheet-like cylindrical body is formed of a laminated body, it is preferable that the temperature is 55 ° C. higher than the melting temperature of the forming material forming the inner layer. In particular, it is preferably 75 to 105 ° C. higher. Although the specific mold temperature varies depending on the material for forming the cylindrical body 3, for example, the mold temperature is preferably 190 to 250 ° C, more preferably 210 to 240 ° C. The seal surface pressure in the heating sealing process also differs by the material for forming the sheet-shaped cylindrical body 3 or the like, but more that is preferably 15~150N / cm 2, a 35~75N / cm 2 preferable. The seal strength of the seal portions 5 and 6 is preferably 20 to 65 N / 1 cm width, and particularly preferably 30 to 65 N / 1 cm width.

加熱プレスにより、シート状筒状体３には、図２，図３に示すように、上端側シール部５と、下端側シール部６が形成される。
上端側シール部５は、２つの加熱プレス面７１ａ，７１ｂにより筒状体３の上端部の両肩に形成された２つのシール部５２，５３からなる。シール部５２，５３の間には、非シール部である排出ポート取付部５１が形成されている。シート状筒状体３の上端開口部は、排出ポート取付部５１を除いてシールされている。本発明の実施例の排出ポート取付部５１は、中央から左寄りに形成されている。下端側シール部６は、２つの加熱プレス面７２ａ，７２ｂよりシート状筒状体３の下端部の両肩に形成された２つのシール部６２，６３からなる。シール部６２，６３は、ほぼ対照形状となっている。シール部６２，６３の間には、非シール部である排出ポート取付部６１が形成されている。排出ポート取付部６１は、下端部のほぼ中心に形成されている。シート状筒状体３の下端開口部は、排出ポート取付部６１を除いてシールされている。上端側シール部５と下端側シール部６の内側には、金型７０によりヒートシールされないため薬剤室形成部１５ａ，１５ｂが形成される。 As shown in FIGS. 2 and 3, an upper end side seal portion 5 and a lower end side seal portion 6 are formed in the sheet-like cylindrical body 3 by the heating press.
The upper end side seal portion 5 includes two seal portions 52 and 53 formed on both shoulders of the upper end portion of the cylindrical body 3 by two heat press surfaces 71a and 71b. A discharge port mounting portion 51 that is a non-seal portion is formed between the seal portions 52 and 53. The upper end opening of the sheet-like cylindrical body 3 is sealed except for the discharge port attachment portion 51. The discharge port mounting portion 51 of the embodiment of the present invention is formed on the left side from the center. The lower end side seal portion 6 includes two seal portions 62 and 63 formed on both shoulders of the lower end portion of the sheet-like cylindrical body 3 from the two heating press surfaces 72a and 72b. The seal portions 62 and 63 have a substantially contrast shape. A discharge port mounting portion 61 that is a non-seal portion is formed between the seal portions 62 and 63. The discharge port mounting portion 61 is formed at substantially the center of the lower end portion. The lower end opening of the sheet-like cylindrical body 3 is sealed except for the discharge port attachment 61. Inside the upper end side seal portion 5 and the lower end side seal portion 6, drug chamber forming portions 15 a and 15 b are formed because they are not heat sealed by the mold 70.

加熱プレス工程は、上端側シール部及び下端側シール部の両端部が薬剤室側に突出する形態となるように行うものであることが好ましい。また、加熱プレス工程は、上端側シール部及び下端側シール部の内縁が側辺に向かうに従って向かい合う上端もしくは下端側に近づく形態となるように行うことが好ましい。本発明の実施例では、熱金型７０が上述したような構成をしているため、図２，図３に示すように、上端側シール部５２，５３と下端側シール部６２，６３の両端部は、薬剤室形成部１５ａ，１５ｂ側に突出している。上端側シール部５と下端側シール部６の両端部は、外側に向かって湾曲するような形状となっている。また、上端側シール部５と下端側シール部６の両端部は、薬剤室形成部１５ａ，１５ｂに向かって徐々に細くなっている。
上端側シール部５（５２，５３）及び下端側シール部６（６２，６３）の内縁部には、図２，図３に示すように、上述した突条部７７，７６，７８，７９により形成された、強シール部が形成されるとともに膨出部５８，６８が形成される。強シール部が形成されることにより、シール際における切れもしくは剥離が防止される。 The heat pressing step is preferably performed so that both end portions of the upper end side seal portion and the lower end side seal portion protrude in the medicine chamber side. Moreover, it is preferable to perform a hot press process so that it may become a form which approaches the upper end or lower end side which faces the inner edge of an upper end side seal part and a lower end side seal part toward a side. In the embodiment of the present invention, since the thermal mold 70 is configured as described above, both ends of the upper end side seal portions 52 and 53 and the lower end side seal portions 62 and 63 as shown in FIGS. The portion protrudes toward the drug chamber forming portions 15a and 15b. Both end portions of the upper end side seal portion 5 and the lower end side seal portion 6 are shaped to bend outward. Further, both end portions of the upper end side seal portion 5 and the lower end side seal portion 6 are gradually narrowed toward the drug chamber forming portions 15a and 15b.
As shown in FIGS. 2 and 3, the above-described protrusions 77, 76, 78, and 79 are provided on the inner edge portions of the upper end side seal portion 5 (52, 53) and the lower end side seal portion 6 (62, 63). The formed strong seal portion is formed and the bulging portions 58 and 68 are formed. By forming the strong seal portion, cutting or peeling at the time of sealing is prevented.

曲げ反発性の高いシート状筒状体の加熱プレス工程の際には、図１に示すシート状筒状体３の折り返し部（側辺７，８）付近に空気が残存することがあり、この状態において強く冷却プレスすると、残存空気がシール部（密着部）側に押し出され気泡が形成されることがある。この気泡が潰れるとピンホールとなることが多い。特に、折り返し部（側辺７，８）に近い液体収納部１５の内縁部（シール際）およびその付近においては、冷却プレスする際に気泡あるいは空気の通り道が形成されやすいためピンホールが生じやすい。   In the heat pressing step of the sheet-like cylindrical body having high bending resilience, air may remain in the vicinity of the folded portion (sides 7 and 8) of the sheet-like cylindrical body 3 shown in FIG. When strongly cooled and pressed in the state, the remaining air may be pushed out to the seal part (adhesion part) side to form bubbles. When these bubbles are crushed, they often become pinholes. In particular, in the inner edge portion (when sealing) near the folded portion (sides 7 and 8) and in the vicinity thereof, bubbles or air passages are likely to be formed during cooling press, so that pinholes are likely to occur. .

また、上述した加熱プレス工程により、上端側シール部５及び下端側シール部６と薬剤室形成部１５ａ，１５ｂとの境界部付近には、膨出部５８，６８が形成されるとともに、図１０に示すように、膨出部５８，６８付近のシート３ａ，３ｂ間には、不完全溶着部５９が形成される。言い換えると、不完全溶着部５９は、未溶着部である薬剤室形成部１５と溶着部である上端側シール部５（５２，５３）及び下端側シール部６（６２，６３）との境界部付近に形成されている。不完全溶着部５９とは、シート状筒状体３を構成するシート同士がある程度溶着しているが、完全には溶着していない部分である。曲げ反発性の高いシートにより構成されたシート状筒状体３をシールした場合、このような不完全溶着部が存在すると、図１１に示すように、未溶着部分のシートが伸びようとする反発により、不完全溶着部５９と溶着部５２，５３，６２，６３との境界部付近のシートが内部から延ばされ、肉薄部６４もしくはピンホールが形成されるおそれがある。このような問題は、特に、上端側シール部５及び下端側シール部６の両側部と薬剤室形成部１５ａ，１５ｂとの境界部及びその周辺部５２ａ，５３ａ，６２ａ，６３ａにて起こりやすい。   In addition, bulging portions 58 and 68 are formed in the vicinity of the boundary between the upper end side seal portion 5 and the lower end side seal portion 6 and the drug chamber forming portions 15a and 15b by the above-described hot pressing process, and FIG. As shown, an incompletely welded portion 59 is formed between the sheets 3a and 3b in the vicinity of the bulging portions 58 and 68. In other words, the incompletely welded portion 59 is a boundary portion between the drug chamber forming portion 15 that is an unwelded portion and the upper end side seal portion 5 (52, 53) and the lower end side seal portion 6 (62, 63) that are welded portions. It is formed in the vicinity. The incompletely welded portion 59 is a portion where the sheets constituting the sheet-like cylindrical body 3 are welded to some extent but are not completely welded. When the sheet-like cylindrical body 3 composed of a sheet having high bending resilience is sealed, if such an incompletely welded portion is present, as shown in FIG. As a result, the sheet in the vicinity of the boundary between the incompletely welded portion 59 and the welded portions 52, 53, 62, and 63 may be extended from the inside, and a thin portion 64 or a pinhole may be formed. Such a problem is particularly likely to occur at the boundary portions between the both side portions of the upper end side seal portion 5 and the lower end side seal portion 6 and the drug chamber forming portions 15a, 15b and the peripheral portions 52a, 53a, 62a, 63a.

また、医療用容器の製造方法においては、仕切用シール形成工程が行われる場合もある。仕切用シール形成工程は、薬剤室の押圧により剥離可能な弱シール部を形成する工程である。この仕切用シール形成工程により形成される仕切用シール部９により、薬剤室１５は、薬剤室１５ａと薬剤室１５ｂに区分される。仕切用シール部９は、軟質バッグ２の中央付近を水平に延びており、両端部が側辺７，８に到達している。そして、仕切用シール部９の両端部は、図１に示すように、二股に分岐している。そして、仕切用シール部９の分岐部の間には、押圧により剥離しないシール部９ａが形成されていることが好ましい。仕切用シール形成工程は、上述した熱プレス工程の前後いずれに行ってもよい。   Moreover, in the manufacturing method of a medical container, the partition seal formation process may be performed. The partition seal forming step is a step of forming a weak seal portion that can be peeled off by pressing the drug chamber. The drug chamber 15 is divided into a drug chamber 15a and a drug chamber 15b by the partition seal portion 9 formed by the partition seal forming step. The partition seal portion 9 extends horizontally around the center of the soft bag 2, and both end portions reach the side edges 7 and 8. Then, both end portions of the partition seal portion 9 are bifurcated as shown in FIG. And it is preferable that the seal part 9a which is not peeled off by pressing is formed between the branch parts of the partition seal part 9. The partition seal forming step may be performed either before or after the hot press step described above.

このように、複数の薬剤室を有することにより、異なる成分の複数の薬剤を無菌的に医療用容器１内にて混合することができる。また、複数の薬剤室を有することにより、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。なお、医療用容器は、仕切用シール部を有していなくてもよい。なお、医療用容器１としては、上述したように２つの薬剤室を有しているものに限定されず、３つ以上の薬剤室を有しているものであってもよい。   Thus, by having a plurality of medicine chambers, a plurality of medicines having different components can be aseptically mixed in the medical container 1. In addition, by having a plurality of drug chambers, 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 is applied when it is preferable to mix both liquids in use. be able to. Note that the medical container may not have the partition seal portion. Note that the medical container 1 is not limited to the one having two drug chambers as described above, and may have three or more drug chambers.

仕切用シール形成工程は、加熱プレスにより行うことが好ましく、金型の温度は、シート状筒状体３の形成材料の溶融温度より１０℃以上低い温度で行うことが好ましい。具体的には、シート状筒状体３の形成材料の溶融温度より１０〜２０℃低い温度範囲において行うことが好ましい。また、シート状筒状体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１０℃以上低いものとすることが好ましい。特に、１０〜２０℃低いものとすることが好ましい。金型の温度は、筒状体２の形成材料によっても相違するが、例えば、金型温度が好ましくは１１５〜１３５℃、より好ましくは１２０〜１２５℃とすることが好ましい。また、弱シール工程におけるシール面圧は、筒状体２の形成材料等によっても相違するが、６０〜１２０Ｎ／ｃｍ２であるのが好ましく、７０〜９５Ｎ／ｃｍ２であることがより好ましい。そして、この弱シール部９は、薬剤室に液体が充填された状態の医療用容器１を指等で押圧すること等により、剥離可能な程度のシール強度を備える。仕切用シール部９のシール強度は、２．５〜１５Ｎ／１ｃｍ幅であることが好ましく、特に、４〜８Ｎ／１ｃｍ幅であることが好ましい。なお、本発明の医療用容器の製造方法においては、仕切用シール形成工程を行わなくてもよい。 The partition seal forming step is preferably performed by a hot press, and the mold temperature is preferably 10 ° C. or more lower than the melting temperature of the forming material of the sheet-like cylindrical body 3. Specifically, it is preferably performed in a temperature range lower by 10 to 20 ° C. than the melting temperature of the forming material of the sheet-like cylindrical body 3. Moreover, when the sheet-like cylindrical body is formed of a laminated body, it is preferable that the sheet-like cylindrical body be at least 10 ° C. lower than the melting temperature of the forming material forming the inner layer. In particular, it is preferably 10 to 20 ° C lower. Although the temperature of the mold varies depending on the material for forming the cylindrical body 2, for example, the mold temperature is preferably 115 to 135 ° C, more preferably 120 to 125 ° C. The seal surface pressure in the weak seal step is different depending cylindrical body 2 of the forming material or the like, is preferably from 60~120N / cm 2, more preferably 70~95N / cm 2. And this weak seal | sticker part 9 is equipped with the seal | sticker intensity | strength of the grade which can peel by pressing the medical container 1 of the state with which the chemical | medical agent chamber was filled with the liquid with a finger | toe etc. The sealing strength of the partition seal portion 9 is preferably 2.5 to 15 N / 1 cm width, and particularly preferably 4 to 8 N / 1 cm width. In addition, in the manufacturing method of the medical container of this invention, it is not necessary to perform the partition seal formation process.

薬剤室形成部１５ａと薬剤室形成部１５ｂの容積は、内部に収納する薬剤１６，１７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、１００〜５０００ｍｌ程度であるのがより好ましい。薬剤室形成部１５ａ，１５ｂに収容される薬剤１６，１７としては、異なった成分のものを収容することが好ましい。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、経口栄養剤等が挙げられる。   The volume of the drug chamber forming portion 15a and the drug chamber forming portion 15b varies depending on the types of the drugs 16 and 17 accommodated therein, but is usually about 50 to 5000 ml, preferably about 100 to 5000 ml. Is more preferable. As the medicines 16 and 17 accommodated in the medicine chamber forming portions 15a and 15b, it is preferable to accommodate different components. For example, a combination of an amino acid electrolyte solution and a glucose solution, a glucose solution and a sodium bicarbonate solution, and the like can be given. In addition, when the weak seal portion 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, peritoneal dialysis. Liquids, oral nutrients and the like.

次に、加熱プレス工程を行った直後の溶融状態の上端側シール部５及び下端側シール部６を冷却金型を用いて行う冷却プレス工程について説明する。
図１２は、本発明の医療用容器の製造方法に使用される金型を構成する熱金型の外観図である。
冷却プレス工程は、上端側シール部５及び下端側シール部６を冷却金型９０によりプレスすることにより行うものである。そして、冷却プレス工程は、加熱プレス工程において、上端側シール部５と薬剤室形成部１５ａとの境界部付近に形成された膨出部５８の両側下端部５８ａ、５８ｂならびに下端側シール部６と薬剤室形成部１５ｂとの境界部付近に形成された膨出部６８の両側上端部６８ａ，６８ｂが、冷却金型９０により冷却されるとともに、膨出部の両側部分５８ａ，５８ｂ，６８ａ，６８ｂを完全に押しつぶさないように行われる。 Next, the cooling press process which performs the upper end side seal part 5 and the lower end side seal part 6 of the molten state immediately after performing a heat press process using a cooling die is demonstrated.
FIG. 12 is an external view of a thermal mold constituting a mold used in the method for producing a medical container of the present invention.
The cooling press step is performed by pressing the upper end side seal portion 5 and the lower end side seal portion 6 with the cooling mold 90. The cooling press process includes both lower ends 58a and 58b of the bulging portion 58 formed near the boundary between the upper end side seal portion 5 and the drug chamber forming portion 15a and the lower end side seal portion 6 in the hot press step. Both upper ends 68a and 68b of the bulging portion 68 formed near the boundary with the drug chamber forming portion 15b are cooled by the cooling mold 90 and both side portions 58a, 58b, 68a and 68b of the bulging portion. It is done not to crush completely.

加熱プレス工程の際に、図２，図３，図４，図５に示すシート状筒状体３の折り返し部（側辺７，８）付近に空気が残存することがあり、この状態で冷却プレスすると、残存空気が溶着部側に押し出され気泡が形成され、気泡が潰れるとピンホールが発生するおそれがある。特に、側辺７，８に近い薬剤室形成部１５ａ，１５ｂと溶融状態のシール部５，６との境界部およびその周辺部５２ａ，５３ａ，６２ａ，６３ａにおいて、冷却プレスする際に気泡もしくは空気の通り道が形成されやすいためピンホールが生じやすい。しかし、上記のようにすることにより、上述した不完全溶着部５９が存在することによるシール際における肉薄部の形成もしくはピンホールの発生を防止することができる。   During the hot pressing process, air may remain in the vicinity of the folded portion (sides 7 and 8) of the sheet-like cylindrical body 3 shown in FIGS. 2, 3, 4 and 5, and cooling is performed in this state. When pressed, residual air is pushed out toward the welded portion to form bubbles, and if the bubbles are crushed, pinholes may be generated. In particular, at the boundary between the drug chamber forming portions 15a and 15b near the side edges 7 and 8 and the melted seal portions 5 and 6 and the peripheral portions 52a, 53a, 62a and 63a, bubbles or air A pinhole is likely to occur because a passageway is easily formed. However, by doing as described above, it is possible to prevent the formation of a thin portion or the occurrence of pinholes at the time of sealing due to the presence of the incompletely welded portion 59 described above.

冷却プレス工程は、上端側シール部５及び下端側シール部６をプレスするものの、上記の膨出部の両側部分５８ａ，５８ｂ，６８ａ，６８ｂは、上端側シール部５及び下端側シール部６のプレスされる部分に比べて、冷却金型により弱くプレス（弱プレスと言うことができる）される。言い換えれば、冷却プレス工程では、上端側シール部５および下端側シール部６の膨出部の両側部分５８ａ，５８ｂ，６８ａ，６８ｂ以外の部分は、冷却金型により強くプレス（強プレスと言うことができる）される。なお、冷却プレス工程では、両側下端部５８ａ，５８ｂを除く部分の上端側シール部側の膨出部５８は、両側下端部５８ａ、５８ｂの膨出部のプレスと同様のプレス（弱プレス）であっても上記の強プレスであってもよい。同様に、両側上端部６８ａ，６８ｂを除く部分の下端側シール部側の膨出部６８は、両側上端部６８ａ、６８ｂの膨出部のプレスと同様のプレス（弱プレス）であっても上記の強プレスであってもよい。   In the cooling press process, the upper end side seal portion 5 and the lower end side seal portion 6 are pressed. However, the both side portions 58a, 58b, 68a, 68b of the bulging portion are the same as those of the upper end side seal portion 5 and the lower end side seal portion 6. Compared with the portion to be pressed, it is weakly pressed by the cooling mold (it can be said to be weak press). In other words, in the cooling press process, the portions other than the both side portions 58a, 58b, 68a, 68b of the bulging portions of the upper end side seal portion 5 and the lower end side seal portion 6 are strongly pressed by the cooling mold (referred to as strong press). Is possible). In the cooling press step, the bulging portion 58 on the upper end side seal portion side except for the lower end portions 58a and 58b on both sides is a press (weak press) similar to the pressing on the bulging portions on both lower end portions 58a and 58b. Even the above-described strong press may be used. Similarly, even if the bulging portion 68 on the lower end side seal portion side excluding the upper end portions 68a and 68b on both sides is the same press (weak press) as the press on the bulging portions on the upper end portions 68a and 68b on both sides, It may be a strong press.

また、冷却プレス工程は、冷却金型９０が両側部分５８ａ，５８ｂ，６８ａ，６８ｂを含む膨出部５８，６８を押圧するとともに、膨出部５８，５９付近の薬剤室形成部１５ａ，１５ｂを形成するシート表面に実質的に接触しないように行うことが好ましい。
冷却プレス工程に使用される冷却金型９０は、図１２に示すように、上端側シール部５及び下端側シール部６をそれらの両側部と薬剤室形成部１５ａ，１５ｂとの境界部及びその周辺部５２ａ，５３ａ，６２ａ，６３ａを除きプレスするメインプレス面９３，９４と、膨出部５８，６８の両側部５８ａ，５８ｂ，６８ａ，６８ｂをプレスする膨出部プレス面９５，９６と、薬剤室形成部上に配置される非プレス面９９，１００とを備えている。 In the cooling press step, the cooling mold 90 presses the bulging portions 58 and 68 including both side portions 58a, 58b, 68a and 68b, and the drug chamber forming portions 15a and 15b near the bulging portions 58 and 59 are pressed. It is preferable to carry out so as not to substantially contact the surface of the sheet to be formed.
As shown in FIG. 12, the cooling mold 90 used in the cooling press step includes an upper end side seal portion 5 and a lower end side seal portion 6 at the boundary portion between the both side portions and the drug chamber forming portions 15a and 15b, and its Main press surfaces 93, 94 for pressing except for the peripheral portions 52a, 53a, 62a, 63a, and bulging portion press surfaces 95, 96 for pressing both side portions 58a, 58b, 68a, 68b of the bulging portions 58, 68; And non-pressing surfaces 99 and 100 disposed on the medicine chamber forming portion.

冷却プレス工程に使用される金型は、図１２に示す冷却金型９０と、冷却金型受け台からなる。冷却金型受け台としては、上述した受け台８０が用いられる。
冷却金型９０は、図１２に示すように、上側部分に設けられ溶融状態の上端側シール部５に冷却プレス工程を施す金型部分９１と、下側部分に設けられ溶融状態の下端側シール部６に冷却プレス工程を施す金型部分９２からなる。冷却金型９０は、金型部分９１と金型部分９２を有することによりシート状筒状体３の上端側シール部５と別のシート状筒状体３の下端側シール部６とに同時に冷却プレス工程を施すことができる。 The mold used in the cooling press process includes a cooling mold 90 shown in FIG. 12 and a cooling mold cradle. As the cooling mold cradle, the cradle 80 described above is used.
As shown in FIG. 12, the cooling mold 90 includes a mold part 91 that is provided in the upper part and performs a cooling press process on the molten upper end side seal part 5, and a lower end seal in the molten state that is provided in the lower part. It consists of a mold part 92 for subjecting the part 6 to a cooling press process. The cooling mold 90 includes the mold part 91 and the mold part 92 so that the cooling is simultaneously performed on the upper end side seal part 5 of the sheet-like cylindrical body 3 and the lower end side seal part 6 of another sheet-like cylindrical body 3. A pressing process can be performed.

金型部分９１は、冷却金型９０の中央から上端側に向かって形成されたメインプレス面９３と、メインプレス面９３の両側部の上端側に設けられた膨出部プレス面（言い換えれば、側部プレス部）９５と、メインプレス面９３の上端側かつ膨出部プレス面９５の内側部分に形成された非プレス面９９を備えている。膨出部プレス面９５はメインプレス面９３から図１２の上端側に延びる形状となっている。メインプレス面９３、膨出部プレス面９５、非プレス面９９は、この順で高さが低くなるように形成されている。また、メインプレス面９３は、排出ポート取付部５１に対応する部分も含めて平坦に形成されている。   The mold portion 91 includes a main press surface 93 formed from the center of the cooling mold 90 toward the upper end side, and a bulging portion press surface (in other words, provided on both upper end sides of the main press surface 93). Side press portion) 95 and a non-press surface 99 formed on the upper end side of the main press surface 93 and on the inner side portion of the bulge portion press surface 95. The bulging portion press surface 95 has a shape extending from the main press surface 93 to the upper end side in FIG. The main press surface 93, the bulging portion press surface 95, and the non-press surface 99 are formed so that the height decreases in this order. Further, the main press surface 93 is formed flat including a portion corresponding to the discharge port mounting portion 51.

金型部分９２は、冷却金型９０の中央から下端側に向かって形成されメインプレス面９３と連続するように形成されたメインプレス面９４と、メインプレス面９４の両側部の下端側に設けられた膨出部プレス面（言い換えれば、側部プレス部）９６と、メインプレス面９４の下端側かつ膨出部プレス面９６の内側部分に形成された非プレス面１００を備えている。メインプレス面９４、膨出部プレス面９６、非プレス面１００は、この順に高さが低くなるように形成されている。また、メインプレス面９４は、排出ポート取付部６１に対応する部分も含めて平坦に形成されている。   The mold portion 92 is formed from the center of the cooling mold 90 toward the lower end side, and is formed on the lower end side of the both sides of the main press surface 94. The main press surface 94 is formed to be continuous with the main press surface 93. And a non-pressing surface 100 formed on the lower end side of the main press surface 94 and on the inner side of the bulging portion press surface 96. The main press surface 94, the bulging portion press surface 96, and the non-press surface 100 are formed so that the height decreases in this order. Further, the main press surface 94 is formed flat including a portion corresponding to the discharge port mounting portion 61.

また、メインプレス面、膨出部プレス面はそれぞれ平坦面となっている。膨出部プレス面９５，９６は、メインプレス面９３，９４に対して、０．２５〜０．３５ｍｍ低く形成されていることが好ましい。また、膨出部プレス面は、図１２の中央部から上端、下端に向かって高さが低くなっていくものであってもよい。また、メインプレス面９３とメインプレス面９４の内縁部は面取されていることが好ましい。これにより、シール部の内縁におけるシールの剥離がより防止される。   Moreover, the main press surface and the bulging portion press surface are flat surfaces. The bulging portion press surfaces 95 and 96 are preferably formed 0.25 to 0.35 mm lower than the main press surfaces 93 and 94. Further, the bulging portion press surface may have a height that decreases from the central portion of FIG. 12 toward the upper end and the lower end. Further, the inner edge portions of the main press surface 93 and the main press surface 94 are preferably chamfered. Thereby, peeling of the seal | sticker in the inner edge of a seal | sticker part is prevented more.

図１３、図１４は、図１２のＡ−Ａ線部分にて冷却プレス工程時における金型および医療用容器を切断した場合の端面を説明するための説明図である。
上述した冷却金型９０と受け台８０を用いて冷却プレス工程を行うと、図１３の状態から図１４の状態となる。つまり、メインプレス面９３，９４により、上端側シール部５もしくは下端側シール部６の両側端部を除いて冷却プレスされ、膨出部プレス面９５，９６により、膨出部５８，６８の両側端部５８ａ，５８ｂ，６８ａ，６８ｂが冷却プレスされる。なお、膨出部５８ａ，５８ｂ，６８ａ，６８ｂ部分を除く、上端側シール部５，６の両側端部は、冷却プレスされない。また、図１４に示すように、膨出部プレス面９５，９６によるプレスは、膨出部５８ａ，５８ｂ，６８ａ，６８ｂを完全に押しつぶさず、膨出部プレス面９５，９６が薬剤室形成部分１５ａ，１５ｂを構成するシート３ａの表面と接触しないように行われる。 FIGS. 13 and 14 are explanatory views for explaining an end surface when the mold and the medical container are cut at the time of the cooling press process at the line AA in FIG. 12.
When the cooling press process is performed using the cooling mold 90 and the cradle 80 described above, the state shown in FIG. 13 is changed to the state shown in FIG. That is, the main press surfaces 93 and 94 are cooled and pressed except for both end portions of the upper end side seal portion 5 or the lower end side seal portion 6, and the bulge portion press surfaces 95 and 96 are both sides of the bulge portions 58 and 68. The ends 58a, 58b, 68a, 68b are cooled and pressed. It should be noted that both side end portions of the upper end side seal portions 5 and 6 except for the bulging portions 58a, 58b, 68a and 68b are not cooled and pressed. Further, as shown in FIG. 14, the press by the bulging portion press surfaces 95, 96 does not completely crush the bulging portions 58a, 58b, 68a, 68b, and the bulging portion press surfaces 95, 96 are the drug chamber forming portions. This is performed so as not to come into contact with the surface of the sheet 3a constituting 15a, 15b.

このように膨出部の少なくも両側部である膨出部５８ａ，５８ｂ，６８ａ，６８ｂをプレスすることにより、図１０に示す不完全溶着部５９を、図１４に示すように、完全に溶着させることができる。また、このように膨出部をプレスすることにより、不完全溶着部５９に存在するエアーが溶着部に押し込まれることによりピンホールが発生するおそれがない。一方、図１５に示すように、膨出部プレス面９５、９６が、膨出部を完全に押しつぶし、シート表面３ａと接触するようにプレスすると、不完全溶着部５９に存在するエアーが溶着部５（６）に押し込まれ、シール際（不完全溶着部５９と溶着部との境界部付近）のシートに肉薄部もしくはピンホールが形成されるおそれがある。
そして、冷却プレス工程は、冷却プレス時における膨出部プレス面とメインプレス面間の距離が、シート状筒状体におけるシート１枚の厚さｔに対して、０．７６ｔ〜１．１ｔの範囲内となるように行われるものであることが好ましい。特に、０．８５ｔ〜 ０．９７ｔの範囲内となるように行われるものであることが好ましい。 By pressing the bulging portions 58a, 58b, 68a, 68b which are at least both sides of the bulging portion in this way, the incompletely welded portion 59 shown in FIG. 10 is completely welded as shown in FIG. Can be made. Further, by pressing the bulging portion in this way, there is no possibility that pinholes are generated by the air existing in the incompletely welded portion 59 being pushed into the welded portion. On the other hand, as shown in FIG. 15, when the bulging portion press surfaces 95 and 96 completely crush the bulging portion and press it so as to contact the sheet surface 3 a, the air present in the incompletely welded portion 59 is welded. 5 (6), there is a possibility that a thin portion or a pinhole may be formed on the sheet at the time of sealing (near the boundary portion between the incompletely welded portion 59 and the welded portion).
In the cooling press step, the distance between the bulging portion press surface and the main press surface at the time of the cooling press is 0.76 t to 1.1 t with respect to the thickness t of one sheet in the sheet-like cylindrical body. It is preferable to be performed so as to be within the range. In particular, it is preferable to be performed so as to be within the range of 0.85 t to 0.97 t.

また、加熱プレス工程および冷却プレス工程は、シート状筒状体の熱シール・冷却プレス部分の厚さＳ１が、シート状筒状体におけるシート１枚の厚さｔに対して、１．２ｔ〜１．５ｔの範囲内となり、上端側シール部及び下端側シール部の両側部と薬剤室形成部との境界部における厚さが、１．９６ｔ〜２．７ｔとなるように行うものであることが好ましい。特に、２．０ｔ〜 ２．６ｔとなるように行われるものであることが好ましい。
特に、上記距離ｄが、０．７６ｔ〜１．１ｔの範囲内であり、かつ、上記厚さＳ１が、１．２ｔ〜１．５ｔの範囲内、さらに、上記厚さＳ２が、２．０ｔ〜２．６ｔであることが好ましい In addition, in the heat press process and the cooling press process, the thickness S1 of the heat seal / cooling press portion of the sheet-like cylindrical body is 1.2 t to the thickness t of one sheet in the sheet-like cylindrical body. The thickness is within the range of 1.5 t, and the thickness at the boundary between the both sides of the upper end side seal portion and the lower end side seal portion and the drug chamber forming portion is 1.96 t to 2.7 t. Is preferred. In particular, it is preferably performed so as to be 2.0t to 2.6t.
In particular, the distance d is in the range of 0.76 t to 1.1 t, the thickness S1 is in the range of 1.2 t to 1.5 t, and the thickness S2 is 2.0 t. ~ 2.6t is preferred

冷却金型９０における膨出部プレス面９５，９６とメインプレス面９３，９４間の段差ｄは、医療用容器１を構成するシート３ａ，３ｂの一枚の厚みｔに対して、０．７６ｔ〜１．１ｔの範囲内であることが好ましい。特に、０．８５ｔ〜０．９７ｔの範囲内であることが好ましい。このようなものであれば、膨出部プレス面９５，９６にて膨出部５８ａ，５８ｂ，６８ａ，６８ｂを適度に押圧し不完全溶着部５９を完全に溶着部させることができ、不完全溶着部５９に存在するエアーを溶着部に押し込むことがない。   The level difference d between the bulging portion press surfaces 95 and 96 and the main press surfaces 93 and 94 in the cooling mold 90 is 0.76 t relative to the thickness t of one sheet 3a and 3b constituting the medical container 1. It is preferable to be within the range of -1.1t. In particular, it is preferably within the range of 0.85t to 0.97t. If this is the case, the bulging portions 58a, 58b, 68a, 68b can be appropriately pressed by the bulging portion press surfaces 95, 96, and the incompletely welded portion 59 can be completely welded. Air existing in the welded portion 59 is not pushed into the welded portion.

冷却金型プレス工程において、金型の温度は、１０〜３０℃で行うことが好ましく、特に、１５〜２５℃であることが好ましい。また、メインプレス面９３，９４におけるシール面圧は、筒状体２の形成材料等によっても相違するが、１０〜１５０Ｎ／ｃｍ２であるのが好ましく、３０〜７５Ｎ／ｃｍ２であることがより好ましい。冷却プレスのプレス時間は、２〜８秒であることが好ましい。また、膨出部プレス面におけるシール面圧は、筒状体２の形成材料等によっても相違するが、１０〜１５０Ｎ／ｃｍ２であるのが好ましく、３０〜７５Ｎ／ｃｍ２であることがより好ましい。 In the cooling mold pressing step, the mold temperature is preferably 10 to 30 ° C, and particularly preferably 15 to 25 ° C. The seal surface pressure in the main pressing surface 93 and 94, which varies depending on the material for forming the cylindrical body 2 or the like, it is preferably from 10~150N / cm 2, a 30~75N / cm 2 More preferred. The press time of the cooling press is preferably 2 to 8 seconds. Moreover, the sealing surface pressure at the bulging portion pressing surface, which varies depending formation materials of the tubular body 2, more it is preferably from 10~150N / cm 2, a 30~75N / cm 2 preferable.

また、冷却プレス工程は、シール部５，６の弱冷却プレス実行領域の上下方向への長さが、０．５〜１０ｍｍとなるように行うものであることが好ましい。この程度の長さ弱プレスすればシートの反発を十分に防止することができる。
以上の工程により、本発明の医療用容器１を構成する軟質バッグ２が作製される。
また、本発明は上記のような工程を有するため、曲げ反発性の強いシートにより構成された筒状体をシールした場合、折り返し部のシートの反発性によりシール際に肉薄部もしくはピンホール部が形成されない医療用容器を製造することができる。 Moreover, it is preferable that a cooling press process is performed so that the length to the up-down direction of the weak cooling press execution area | region of the seal parts 5 and 6 may be set to 0.5-10 mm. If the sheet is pressed to such a length, repulsion of the sheet can be sufficiently prevented.
The soft bag 2 which comprises the medical container 1 of this invention is produced according to the above process.
In addition, since the present invention includes the steps as described above, when sealing a cylindrical body composed of a sheet having a strong bending resilience, the thin portion or pinhole portion is not sealed when sealed due to the resilience of the folded portion sheet. Medical containers that are not formed can be manufactured.

次に、上述したように作製した軟質バッグ２の薬剤室形成部１５ａ，１５ｂに上述した薬剤１６，１７を充填した後排出ポート２１，２２を取りつける。薬剤１６，１７としては、上述した薬剤が使用される。排出ポート２１，２２は、それぞれ、排出ポート取付部５１、排出ポート取付部６１に配置してヒートシールされることにより、軟質バッグ２に取りつけられる。排出ポート２１，２２は、公知のものが使用される。排出ポート２１，２２としては、例えば、筒状部材であり、排出口に排出用針が刺通可能なシール材が配置されたものが好ましい。このような構成により、シール材に排出用針を刺通すると薬剤室に収納された薬剤を排出させることができる。また、本発明では排出ポートが軟質バッグの上端部及び下端部のそれぞれに形成されているが、これに限定されず、上端部、下端部のいずれか一方に取りつけられていてもよい。また、軟質バッグには薬剤容器が取りつけられてもよい。また、一端部に薬剤容器が取りつけられ、他端部に排出用ポートが取りつけられていてもよい。
本発明の医療用容器は、上述した製造方法で作製されたものである。このため、曲げ反発性の強いシートにより構成された筒状体をシールすることにより製造された場合であっても、筒状体の折り返し部に肉薄部もしくはピンホール部が形成されていない。 Next, after the medicines 16 and 17 are filled in the medicine chamber forming portions 15a and 15b of the soft bag 2 manufactured as described above, the discharge ports 21 and 22 are attached. As the drugs 16 and 17, the above-described drugs are used. The discharge ports 21 and 22 are attached to the flexible bag 2 by being disposed in the discharge port attachment portion 51 and the discharge port attachment portion 61 and heat sealed, respectively. Known discharge ports 21 and 22 are used. The discharge ports 21 and 22 are, for example, tubular members, and preferably have a sealing material that allows the discharge needle to be inserted into the discharge port. With such a configuration, when the discharge needle is pierced through the sealing material, the medicine stored in the medicine chamber can be discharged. Moreover, in this invention, although the discharge port is formed in each of the upper end part and lower end part of a soft bag, it is not limited to this, You may attach to either one of an upper end part or a lower end part. In addition, a drug container may be attached to the soft bag. Moreover, the medicine container may be attached to one end, and the discharge port may be attached to the other end.
The medical container of the present invention is produced by the manufacturing method described above. For this reason, even if it is a case where it manufactures by sealing the cylindrical body comprised with the sheet | seat with a strong bending resilience, the thin part or the pinhole part is not formed in the folding | turning part of a cylindrical body.

次に、本発明の医療用容器の製造方法の実施例及び比較例について説明する。
（実施例１）
シート状筒状体として、ポリプロピレンにスチレン−エチレン−ブチレン−スチレンブロック共重合体をブレンドし柔軟化した軟質樹脂をインフレーション成形により肉厚３３０μｍの円筒状［折れ径（横幅２１０ｍｍ）］に成形したものを用いた。
そして、図７に示すような熱金型と、図８に示すように熱金型受け台を用いて、シート状筒状体の上端部及び下端部に加熱プレスにより図２，図３に示す形状のシール部を形成した。加熱プレス面圧は、５５Ｎ／ｃｍ２、熱金型の温度としては、シート状筒状体の形成材料の融点より９０℃高い２２５℃とし、プレス時間は、４秒とした。 Next, the Example and comparative example of the manufacturing method of the medical container of this invention are demonstrated.
(Example 1)
As a sheet-like cylindrical body, a soft resin made by blending polypropylene with a styrene-ethylene-butylene-styrene block copolymer and then softening is formed into a cylindrical shape [folded diameter (width 210 mm)] having a thickness of 330 μm by inflation molding. Was used.
7 and FIG. 8 are used to heat and press the upper end portion and the lower end portion of the sheet-like cylindrical body using a hot die as shown in FIG. 7 and a hot die holder as shown in FIG. A shaped seal was formed. The heating press surface pressure was 55 N / cm 2 , the temperature of the hot mold was 225 ° C., which was 90 ° C. higher than the melting point of the material for forming the sheet-like cylindrical body, and the pressing time was 4 seconds.

次に、図１３に示すような冷却金型と、図６に示すような冷却金型受け台を用いて、溶融状態のシール部を、図２，図３に示す両側部の他端側に入り込んだ部分の先端部を除いて冷却プレスするとともに、先端部と薬剤室形成部との境界部に形成された膨出部を、図１４に示すようにプレスした。冷却プレスのプレス面圧は、５５Ｎ／ｃｍ２であった。金型温度は、２０℃、プレス時間４秒であった。実施例１に用いられた冷却金型の膨出部プレス面はメインプレス面より低く、メインプレス面との高さの差は、０．３ｍｍであった。 Next, using the cooling mold as shown in FIG. 13 and the cooling mold cradle as shown in FIG. 6, the melted seal portion is placed on the other end side of both sides shown in FIGS. 2 and 3. Cooling press was performed except for the tip of the part that entered, and the bulging part formed at the boundary between the tip and the drug chamber forming part was pressed as shown in FIG. The pressing surface pressure of the cooling press was 55 N / cm 2 . The mold temperature was 20 ° C. and the press time was 4 seconds. The bulging portion press surface of the cooling mold used in Example 1 was lower than the main press surface, and the height difference from the main press surface was 0.3 mm.

次に、加熱プレスにより、シート状筒状体の中央部より少し下端側となる位置に図１に示すような形状の剥離可能な弱シール部を形成した。弱シール部の分岐部の縦方向の幅は、２８ｍｍで、中間部の幅は１０ｍｍであった。弱シール部形成のためのシール面圧は、８５Ｎ／ｃｍ２、熱金型の温度は、シート状筒状体の形成材料の融点より１５℃低い１２０℃であり、プレス時間３秒、冷却時間２秒であった。また、弱シール部のシール強度は、３．０〜８．０Ｎ／１ｃｍ幅であった。
そして、図１に示すように薬剤を充填した後、排出ポートを上端部及び下端部に取りつけ、実施例の医療用容器を作製した。 Next, a peelable weak seal portion having a shape as shown in FIG. 1 was formed by a heating press at a position slightly lower than the center portion of the sheet-like cylindrical body. The longitudinal width of the branch portion of the weak seal portion was 28 mm, and the width of the intermediate portion was 10 mm. The seal surface pressure for forming the weak seal portion is 85 N / cm 2 , the temperature of the hot mold is 120 ° C. which is 15 ° C. lower than the melting point of the forming material of the sheet-like cylindrical body, the press time is 3 seconds, and the cooling time is 2 seconds. Moreover, the seal strength of the weak seal portion was 3.0 to 8.0 N / 1 cm width.
And after filling a chemical | medical agent as shown in FIG. 1, the discharge port was attached to the upper end part and the lower end part, and the medical container of the Example was produced.

（実施例２）
冷却金型のメインプレス面と膨出部プレス面との段差を、０．２５ｍｍとした以外は、実施例１と同じ方法により医療用容器を作製した。
（実施例３）
冷却金型のメインプレス面と膨出部プレス面との段差を、０．３５ｍｍとした以外は、実施例１と同じ方法により医療用容器を作製した。
（比較例１）
冷却金型のメインプレス面と膨出部プレス面との段差を、０ｍｍとした以外は、実施例１と同じ方法により医療用容器を作製した。 (Example 2)
A medical container was produced in the same manner as in Example 1 except that the step between the main press surface and the bulging portion press surface of the cooling mold was 0.25 mm.
(Example 3)
A medical container was produced in the same manner as in Example 1 except that the step between the main press surface and the bulging portion press surface of the cooling mold was 0.35 mm.
(Comparative Example 1)
A medical container was produced by the same method as in Example 1 except that the step between the main press surface and the bulging portion press surface of the cooling mold was set to 0 mm.

（比較例２）
冷却金型のメインプレス面と膨出部プレス面との段差を、０．２ｍｍとした以外は、実施例１と同じ方法により医療用容器を作製した。
（参考例１）
冷却金型のメインプレス面と膨出部プレス面との段差を、０．４ｍｍとした以外は、実施例１と同じ方法により医療用容器を作製した。
（参考例２）
冷却金型の側部プレス面と膨出部プレス面との段差を、０．５ｍｍとした以外は、実施例１と同じ方法により医療用容器を作製した。 (Comparative Example 2)
A medical container was produced in the same manner as in Example 1 except that the step between the main press surface and the bulging portion press surface of the cooling mold was 0.2 mm.
(Reference Example 1)
A medical container was produced in the same manner as in Example 1 except that the step between the main press surface and the bulging portion press surface of the cooling mold was 0.4 mm.
(Reference Example 2)
A medical container was produced in the same manner as in Example 1 except that the step between the side press surface and the bulging portion press surface of the cooling mold was set to 0.5 mm.

（比較例３）
冷却金型の側部プレス面と膨出部プレス面との段差を、０．７ｍｍとした以外は、実施例１と同じ方法により医療用容器を作製した。
（比較例４）
冷却金型の側部プレス面と膨出部プレス面との段差を、１．０ｍｍとした以外は、実施例１と同じ方法により医療用容器を作製した。
また、図１０に示すように、実施例１及び比較例１から実施例６の冷却金型によるプレス前における膨出部５８（６８）の頂点と溶着部５２ａ（５３ａ）のシート表面との段差ｄ１は、約０．４５ｍｍであり、膨出部の頂点５８（６８）と未シール部（薬剤室形成部）１５ａ（１５ｂ）のシート表面３ａとの段差ｄ２は、約０．２４ｍｍであり、未シール部のシート表面と溶着部との段差ｄ３は、約０．２ｍｍであり、溶着部の厚み（溶着された２枚のシートの厚み）ｔは、約０．４５ｍｍである。
上述したように作製した実施例１、比較例１〜６の医療用容器を用いて以下の実験を行った。 (Comparative Example 3)
A medical container was produced in the same manner as in Example 1 except that the step between the side press surface and the bulging portion press surface of the cooling mold was 0.7 mm.
(Comparative Example 4)
A medical container was produced in the same manner as in Example 1 except that the step between the side press surface and the bulging portion press surface of the cooling mold was 1.0 mm.
Further, as shown in FIG. 10, the step between the apex of the bulging portion 58 (68) and the sheet surface of the welded portion 52a (53a) before pressing by the cooling molds of Example 1 and Comparative Examples 1 to 6 is used. d1 is about 0.45 mm, the step d2 between the apex 58 (68) of the bulging part and the sheet surface 3a of the unsealed part (drug chamber forming part) 15a (15b) is about 0.24 mm, The step d3 between the sheet surface of the unsealed portion and the welded portion is about 0.2 mm, and the thickness of the welded portion (the thickness of the two sheets welded) t is about 0.45 mm.
The following experiments were conducted using the medical containers of Example 1 and Comparative Examples 1 to 6 produced as described above.

（実験）
医療用容器内の薬液を排出ポートから排出させた後、シール部の両側部の他端側に入り込んだ部分（突出した部分）を水平に切断し、切断面を観察したところ図１６の表１に示す結果となった。
表１によると、膨出部プレス面とメインプレス面の段差ｄが、０ｍｍ、０．２ｍｍのとき、膨出部プレス面により膨出部及び未シール部（薬剤室形成部）のシート表面が強くプレスされるため、シートの反発は生じないが、未シール部のエアーが溶着部に押し込まれることにより泡抱き部が生じる。また、段差が０．５ｍｍ、０．７ｍｍ、１．０ｍｍのときは、膨出部プレス面により膨出部がプレスされないため泡抱き部は生じないが、膨出部がプレスされないことによりシートの反発が生じた。また、段差が０．４ｍｍのときは膨出部プレス面により未シール部のシート表面がプレスされないため泡抱き部は生じないが、膨出部が十分にプレスされないためシートの弱い反発があった。
一方、段差ｄが０．３ｍｍのときは、膨出部プレス面により適度に膨出部がプレスされるため、シートの反発及び泡抱き部は生じなかった。 (Experiment)
After discharging the medical solution in the medical container from the discharge port, the part (protruded part) that entered the other end of both sides of the seal part was cut horizontally, and the cut surface was observed. Table 1 in FIG. The result was shown in.
According to Table 1, when the level difference d between the bulge portion press surface and the main press surface is 0 mm and 0.2 mm, the bulge portion press surface causes the sheet surface of the bulge portion and the unsealed portion (drug chamber forming portion) to Since the sheet is strongly pressed, the sheet is not repelled, but a bubble-embedding part is generated when the air in the unsealed part is pushed into the welded part. In addition, when the step is 0.5 mm, 0.7 mm, or 1.0 mm, the bulging part is not pressed by the bulging part pressing surface, so that no bubble embossing part is generated, but the bulging part is not pressed, so that the sheet A rebound occurred. In addition, when the level difference is 0.4 mm, the sheet surface of the unsealed portion is not pressed by the bulging portion pressing surface, so that the foam-embracing portion does not occur, but since the bulging portion is not sufficiently pressed, there was a weak repulsion of the sheet. .
On the other hand, when the level difference d was 0.3 mm, the bulging portion was appropriately pressed by the bulging portion pressing surface, and thus the sheet repulsion and the bubble holding portion did not occur.

図１は、本発明の医療用容器の一実施例の正面図である。FIG. 1 is a front view of an embodiment of the medical container of the present invention. 図２は、本発明の医療用容器を構成する軟質バッグの上側部分の拡大図である。FIG. 2 is an enlarged view of the upper portion of the soft bag constituting the medical container of the present invention. 図３は、本発明の医療用容器を構成する軟質バッグの下側部分の拡大図である。FIG. 3 is an enlarged view of the lower portion of the soft bag constituting the medical container of the present invention. 図４は、図２に示す軟質バッグの上側部分の部分拡大図である。4 is a partially enlarged view of an upper portion of the soft bag shown in FIG. 図５は、図３に示す軟質バッグの下側部分の部分拡大図である。FIG. 5 is a partially enlarged view of a lower portion of the soft bag shown in FIG. 図６は、本発明の医療用容器の製造方法に使用される金型の説明図である。FIG. 6 is an explanatory diagram of a mold used in the method for producing a medical container of the present invention. 図７は、本発明の医療用容器の製造方法に使用される金型を構成する熱金型の外観図である。FIG. 7 is an external view of a thermal mold constituting a mold used in the method for producing a medical container of the present invention. 図８は、図７に示す熱金型の内縁部分の断面図である。FIG. 8 is a cross-sectional view of the inner edge portion of the thermal mold shown in FIG. 図９は、図７に示す熱金型の内縁部分の断面図である。9 is a cross-sectional view of the inner edge portion of the thermal mold shown in FIG. 図１０は、本発明の医療用容器の製造方法を説明するための説明図である。FIG. 10 is an explanatory view for explaining the method for producing the medical container of the present invention. 図１１は、本発明の医療用容器の製造方法を説明するための説明図である。FIG. 11 is an explanatory view for explaining the method for producing the medical container of the present invention. 図１２は、本発明の医療用容器の製造方法に使用される冷却金型の説明図である。FIG. 12 is an explanatory diagram of a cooling mold used in the method for producing a medical container of the present invention. 図１３は、本発明の医療用容器の製造方法を説明するための説明図である。FIG. 13 is an explanatory view for explaining the method for producing the medical container of the present invention. 図１４は、本発明の医療用容器の製造方法を説明するための説明図である。FIG. 14 is an explanatory view for explaining the method for producing the medical container of the present invention. 図１５は、参考例の医療用容器の製造方法を説明するための説明図である。FIG. 15 is an explanatory diagram for explaining a method of manufacturing a medical container of a reference example. 図１６は、実験結果を示す表である。FIG. 16 is a table showing experimental results.

符号の説明Explanation of symbols

１ 医療用容器
３ シート状筒状体
３ａ シート表面
５ 上端側シール部
６ 下端側シール部
７，８ 側辺
１５ａ，１５ｂ 薬剤室形成部
５２ａ，５３ａ，６２ａ，６３ａ 境界部及びその周辺部
５８，６８ 膨出部
７０ 熱金型
９０ 冷却金型
９５ 側部プレス面
９７ 膨出部プレス面 DESCRIPTION OF SYMBOLS 1 Medical container 3 Sheet-like cylindrical body 3a Sheet surface 5 Upper end side seal part 6 Lower end side seal part 7, 8 Side 15a, 15b Drug chamber formation part 52a, 53a, 62a, 63a A boundary part and its peripheral part 58, 68 Swelling part 70 Thermal mold 90 Cooling mold 95 Side press surface 97 Swelling part press surface

Claims (12)

チューブ状に成形され、折り曲げられることにより形成された２つの側辺と、シールされた上端部及び下端部と、内部に形成された薬剤室と、該薬剤室に収容された薬剤とを備える医療用容器の製造方法であって、該医療用容器の製造方法は、軟質合成樹脂によりチューブを作製し、該チューブを折り曲げることによりシート状筒状体を準備する工程と、該シート状筒状体の上端部及び下端部を熱金型によりプレスして上端側シール部及び下端側シール部を形成し、該上端側シール部と該下端側シール部の内側に薬剤室形成部を形成する加熱プレス工程と、前記上端側シール部及び該下端側シール部を冷却金型を押し当てることにより冷却する冷却プレス工程を行うものであり、かつ、前記冷却プレス工程は、前記加熱プレス工程において前記上端側シール部と前記薬剤室形成部との境界部付近に形成された膨出部の両側下端部ならびに前記下端側シール部と前記薬剤室形成部との境界部付近に形成された膨出部の両側上端部が前記冷却金型により冷却されるとともに該膨出部を完全に押しつぶさないように行うものであることを特徴とする医療用容器の製造方法。 Medical device comprising two sides formed by being bent into a tube shape and bent, sealed upper and lower ends, a drug chamber formed inside, and a drug stored in the drug chamber A method for producing a medical container, the method comprising producing a tube with a soft synthetic resin, preparing a sheet-like cylindrical body by bending the tube, and the sheet-like cylindrical body The upper end portion and the lower end portion are pressed by a hot die to form an upper end side seal portion and a lower end side seal portion, and a heat press for forming a drug chamber forming portion inside the upper end side seal portion and the lower end side seal portion And a cooling press step for cooling the upper end side seal portion and the lower end side seal portion by pressing a cooling mold, and the cooling press step is performed before the heating press step. Lower end portions on both sides of the bulging portion formed near the boundary portion between the upper end side seal portion and the drug chamber forming portion, and a bulging portion formed near the boundary portion between the lower end side seal portion and the drug chamber forming portion. A method for producing a medical container, characterized in that the upper end portions on both sides are cooled by the cooling mold so that the bulging portion is not completely crushed. 前記冷却プレス工程は、前記冷却金型が前記膨出部を押圧するとともに、該膨出部付近の前記薬剤室形成部を形成するシート表面に実質的に接触しないように行うものである請求項１に記載の医療用容器の製造方法。 The cooling press step is performed so that the cooling mold presses the bulging portion and does not substantially contact the sheet surface forming the drug chamber forming portion near the bulging portion. A method for producing a medical container according to 1. 前記冷却プレス工程では、前記上端側シール部および前記下端側シール部は、前記膨出部のプレスよりも強く冷却金型によりプレスされるものである請求項１または２に記載の医療用容器の製造方法。 3. The medical container according to claim 1, wherein in the cooling press step, the upper end side seal portion and the lower end side seal portion are pressed by a cooling mold stronger than the bulge portion press. Production method. 前記冷却プレス工程では、前記両側下端部を除く部分の前記上端側シール部側の膨出部は、前記両側下端部の膨出部のプレスと同様もしくは該プレスよりも強く冷却金型によりプレスされるものであり、前記両側上端部を除く部分の前記下端側シール部側の膨出部は、前記両側上端部の膨出部のプレスと同様もしくは該プレスよりも強く冷却金型によりプレスされるものである請求項１ないし３のいずれかに記載の医療用容器の製造方法。 In the cooling press step, the bulging portion on the upper end side seal portion side of the portion excluding the lower end portions on both sides is pressed by a cooling mold in a manner similar to or stronger than the pressing of the bulging portion at the lower end portions on both sides. The bulging portion on the lower seal portion side of the portion excluding the upper end portions on both sides is pressed by a cooling mold in the same manner as the bulge portion on the upper end portions on both sides or stronger than the press. The method for producing a medical container according to any one of claims 1 to 3, wherein the medical container is a product. 前記加熱プレス工程は、前記上端側シール部及び下端側シール部の内縁が前記側辺に向かうに従って向かい合う他端に近づく形態となるように行うものである請求項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 said heat press process is performed so that it may become a form which approaches the other end which faces the inner edge of the said upper end side seal part and a lower end side seal part toward the said side. A method for producing a medical container. 前記冷却プレス工程に使用される冷却金型は、前記上端側シール部及び下端側シール部をプレスするメインプレス面と、前記膨出部をプレスする膨出部プレス面と、前記薬剤室形成部上に配置される非プレス面とを備えている請求項１ないし５のいずれかに記載の医療用容器の製造方法。 The cooling mold used in the cooling press step includes a main press surface that presses the upper end side seal portion and the lower end side seal portion, a bulge portion press surface that presses the bulge portion, and the drug chamber forming portion. The method for producing a medical container according to any one of claims 1 to 5, further comprising a non-pressing surface disposed on the top. 前記冷却金型における前記膨出部プレス面と前記メインプレス面間の段差は、０．２５〜０．３５mmである請求項６に記載の医療用容器の製造方法。 The method for manufacturing a medical container according to claim 6, wherein a step between the bulging portion press surface and the main press surface in the cooling mold is 0.25 to 0.35 mm. 前記冷却金型における前記膨出部プレス面と前記メインプレス面間の段差は、前記シート状筒状体のシート厚さｔに対して、０．７６ｔ〜１．１ｔの範囲内である請求項６または７に記載の医療用容器の製造方法。 The step between the bulging portion press surface and the main press surface in the cooling mold is in a range of 0.76 t to 1.1 t with respect to a sheet thickness t of the sheet-like cylindrical body. A method for producing a medical container according to 6 or 7. 前記加熱プレス工程および前記冷却プレス工程は、前記シート状筒状体の加熱プレス工程および冷却プレス工程後のシール部分の厚さが、前記シート状筒状体におけるシート１枚の厚さｔに対して、１．２ｔ〜１．５ｔの範囲内となり、前記上端側シール部及び下端側シール部の両側部と前記薬剤室形成部との境界部における厚さが、１．９６ｔ〜２．６ｔとなるように行うものである請求項１ないし８のいずれかに記載の医療用容器の製造方法。 In the heating press process and the cooling press process, the thickness of the seal portion after the heating press process and the cooling press process of the sheet-like cylindrical body is equal to the thickness t of one sheet in the sheet-like cylindrical body. Thus, the thickness at the boundary between the both side portions of the upper end side seal portion and the lower end side seal portion and the drug chamber forming portion is 1.96 t to 2.6 t. The method for producing a medical container according to any one of claims 1 to 8, wherein the method is performed as described above. 前記シート状筒状体は、インフレーション成形によってチューブ状に成形されたものである請求項１ないし８のいずれかに記載の医療用容器の製造方法。 The method for manufacturing a medical container according to any one of claims 1 to 8, wherein the sheet-like cylindrical body is formed into a tube shape by inflation molding. 前記製造方法は、前記薬剤室形成部を仕切る仕切用シール形成工程を有している請求項１ないし１０のいずれかに記載の医療用容器の製造方法。 The said manufacturing method is a manufacturing method of the medical container in any one of Claim 1 thru | or 10 which has the seal | sticker seal formation process which partitions off the said chemical | medical agent chamber formation part. 請求項１ないし１１のいずれかに記載の医療用容器の製造方法により製造されたことを特徴とする医療用容器。

A medical container manufactured by the method for manufacturing a medical container according to any one of claims 1 to 11.

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Publication number Priority date Publication date Assignee Title
JP2011177443A (en) * 2010-03-03 2011-09-15 Terumo Corp Method for manufacturing medical container and medical container
WO2020064675A1 (en) * 2018-09-25 2020-04-02 Fresenius Kabi Deutschland Gmbh Contour-forming welding tool for pulse welding and contour-forming pulse welding method for a medical pack formed as a bag
WO2024157654A1 (en) * 2023-01-26 2024-08-02 富士フイルム株式会社 Manufacturing method for bag of infusion dissolved at time of use

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JPH07171895A (en) * 1993-12-17 1995-07-11 Otsuka Pharmaceut Factory Inc Manufacture of plastic container
JPH11290421A (en) * 1998-04-09 1999-10-26 Nissho Corp Manufacture of bag for medical use
JP2001225403A (en) * 2000-02-18 2001-08-21 Nipro Corp Method for manufacturing bag using inflation tube sheet

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Publication number Priority date Publication date Assignee Title
JP2011177443A (en) * 2010-03-03 2011-09-15 Terumo Corp Method for manufacturing medical container and medical container
WO2020064675A1 (en) * 2018-09-25 2020-04-02 Fresenius Kabi Deutschland Gmbh Contour-forming welding tool for pulse welding and contour-forming pulse welding method for a medical pack formed as a bag
US11498284B2 (en) 2018-09-25 2022-11-15 Fresenius Kabi Deutschland Gmbh Contour-forming welding tool for pulse welding and contour-forming pulse welding method for a medical pack formed as a bag
WO2024157654A1 (en) * 2023-01-26 2024-08-02 富士フイルム株式会社 Manufacturing method for bag of infusion dissolved at time of use

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