WO2000043189A1 - Procede de scellage d'un tube dans un contenant - Google Patents

Procede de scellage d'un tube dans un contenant Download PDF

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Publication number
WO2000043189A1
WO2000043189A1 PCT/US2000/001163 US0001163W WO0043189A1 WO 2000043189 A1 WO2000043189 A1 WO 2000043189A1 US 0001163 W US0001163 W US 0001163W WO 0043189 A1 WO0043189 A1 WO 0043189A1
Authority
WO
WIPO (PCT)
Prior art keywords
planar members
rounded member
interface area
tubing
fluid
Prior art date
Application number
PCT/US2000/001163
Other languages
English (en)
Inventor
Sydney T. Smith
Bradley Buchanan
Larry A. Rosenbaum
Original Assignee
Baxter International Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter International Inc. filed Critical Baxter International Inc.
Priority to KR1020017008626A priority Critical patent/KR20010111092A/ko
Priority to BR0007824A priority patent/BR0007824A/pt
Priority to EP00904398A priority patent/EP1135246A4/fr
Priority to CA 2358653 priority patent/CA2358653A1/fr
Priority to AU26164/00A priority patent/AU764318B2/en
Priority to JP2000594631A priority patent/JP2002535162A/ja
Publication of WO2000043189A1 publication Critical patent/WO2000043189A1/fr

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B1/00Layered products having a non-planar shape
    • B32B1/08Tubular products
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/004Preventing sticking together, e.g. of some areas of the parts to be joined
    • B29C66/0042Preventing sticking together, e.g. of some areas of the parts to be joined of the joining tool and the parts to be joined
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11Joint 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
    • B29C66/112Single lapped joints
    • B29C66/1122Single lap to lap joints, i.e. overlap joints
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/13Single 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
    • B29C66/133Fin-type joints, the parts to be joined being flexible
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/20Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/24Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight
    • B29C66/242Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours
    • B29C66/2422Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being circular, oval or elliptical
    • B29C66/24223Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being closed, i.e. forming closed contours being circular, oval or elliptical being oval
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/347General aspects dealing with the joint area or with the area to be joined using particular temperature distributions or gradients; using particular heat distributions or gradients
    • B29C66/3474General aspects dealing with the joint area or with the area to be joined using particular temperature distributions or gradients; using particular heat distributions or gradients perpendicular to the plane of the joint
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General 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
    • B29C66/51Joining 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
    • B29C66/53Joining single elements to tubular articles, hollow articles or bars
    • B29C66/532Joining single elements to the wall of tubular articles, hollow articles or bars
    • B29C66/5326Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
    • B29C66/53261Enclosing tubular articles between substantially flat elements
    • B29C66/53262Enclosing spouts between the walls of bags, e.g. of medical bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General 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
    • B29C66/63Internally supporting the article during joining
    • B29C66/632Internally supporting the article during joining using a fluid
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General 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
    • B29C66/72General 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
    • B29C66/723General 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
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/80General aspects of machine operations or constructions and parts thereof
    • B29C66/81General 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
    • B29C66/814General 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
    • B29C66/8141General 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
    • B29C66/81431General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined comprising a single cavity, e.g. a groove
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/80General aspects of machine operations or constructions and parts thereof
    • B29C66/81General 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
    • B29C66/814General 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
    • B29C66/8145General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the constructional aspects of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/81451General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the constructional aspects of the pressing elements, e.g. of the welding jaws or clamps being adaptable to the surface of the joint
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
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    • B29C66/80General aspects of machine operations or constructions and parts thereof
    • B29C66/81General 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
    • B29C66/814General 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
    • B29C66/8145General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the constructional aspects of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/81457General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the constructional aspects of the pressing elements, e.g. of the welding jaws or clamps comprising a block or layer of deformable material, e.g. sponge, foam, rubber
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/80General aspects of machine operations or constructions and parts thereof
    • B29C66/83General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
    • B29C66/832Reciprocating joining or pressing tools
    • B29C66/8322Joining or pressing tools reciprocating along one axis
    • B29C66/83221Joining or pressing tools reciprocating along one axis cooperating reciprocating tools, each tool reciprocating along one axis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/90Measuring or controlling the joining process
    • B29C66/91Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/90Measuring or controlling the joining process
    • B29C66/91Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • B29C66/91411Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/90Measuring or controlling the joining process
    • B29C66/91Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9161Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the heat or the thermal flux, i.e. the heat flux
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/90Measuring or controlling the joining process
    • B29C66/91Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/919Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • B29C66/9192Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams
    • B29C66/91921Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature
    • B29C66/91931Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature in explicit relation to the fusion temperature or melting point of the material of one of the parts to be joined
    • B29C66/91935Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature in explicit relation to the fusion temperature or melting point of the material of one of the parts to be joined lower than said fusion temperature
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    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/90Measuring or controlling the joining process
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    • B29C66/919Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • B29C66/9192Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams
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    • B29C66/91941Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature in explicit relation to Tg, i.e. the glass transition temperature, of the material of one of the parts to be joined
    • B29C66/91943Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature in explicit relation to Tg, i.e. the glass transition temperature, of the material of one of the parts to be joined higher than said glass transition temperature
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    • B29C65/022Particular heating or welding methods not otherwise provided for
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    • B29C66/70General 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
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    • B29C66/70General 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
    • B29C66/73General 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
    • B29C66/731General 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 intensive physical properties of the material of the parts to be joined
    • B29C66/7311Thermal properties
    • B29C66/73115Melting point
    • B29C66/73116Melting point of different melting point, i.e. the melting point of one of the parts to be joined being different from the melting point of the other part
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    • B29C66/73General 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
    • B29C66/731General 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 intensive physical properties of the material of the parts to be joined
    • B29C66/7314Electrical and dielectric properties
    • B29C66/73143Dielectric properties
    • BPERFORMING OPERATIONS; TRANSPORTING
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    • B29C66/73General 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
    • B29C66/731General 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 intensive physical properties of the material of the parts to be joined
    • B29C66/7315Mechanical properties
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    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/80General aspects of machine operations or constructions and parts thereof
    • B29C66/81General 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
    • B29C66/814General 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
    • B29C66/8141General 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
    • B29C66/81411General 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
    • B29C66/81421General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined characterised by its cross-section, e.g. transversal or longitudinal, being non-flat being convex or concave
    • B29C66/81423General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined characterised by its cross-section, e.g. transversal or longitudinal, being non-flat being convex or concave being concave
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    • B29C66/90Measuring or controlling the joining process
    • B29C66/91Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • B29C66/91431Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature the temperature being kept constant over time
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    • B29C66/90Measuring or controlling the joining process
    • B29C66/91Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9161Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the heat or the thermal flux, i.e. the heat flux
    • B29C66/91651Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the heat or the thermal flux, i.e. the heat flux by controlling or regulating the heat generated by Joule heating or induction heating
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    • B29K2023/00Use of polyalkenes or derivatives thereof as moulding material
    • BPERFORMING OPERATIONS; TRANSPORTING
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    • B29K2023/00Use of polyalkenes or derivatives thereof as moulding material
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    • B29K2023/06PE, i.e. polyethylene
    • B29K2023/0608PE, i.e. polyethylene characterised by its density
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    • B29K2023/00Use of polyalkenes or derivatives thereof as moulding material
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    • BPERFORMING OPERATIONS; TRANSPORTING
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    • B29K2995/00Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037Other properties
    • B29K2995/007Hardness
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/712Containers; Packaging elements or accessories, Packages
    • B29L2031/7148Blood bags, medical bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00Containers; Receptacles
    • B32B2439/70Food packaging
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00Containers; Receptacles
    • B32B2439/80Medical packaging
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2597/00Tubular articles, e.g. hoses, pipes

Definitions

  • This invention relates generally to a port or dispensing tube for use with flexible containers and more specifically to a method for attaching such a tube to a medical grade or food grade container.
  • beneficial agents are packaged in flexible containers such as IN. bags and are ultimately delivered through tubing such as an administration set to patients to achieve therapeutic effects.
  • Port tubing is a necessary feature of the container and provides access to the contents of the container.
  • IN. bags are most commonly fabricated from polymers such as polyvinyl chloride, ethylene vinyl acetate, or polyolefm alloys, such as those disclosed in commonly assigned U.S. Patent No. 5,686,527.
  • the IN. containers usually have two confronting walls or panels that are attached to one another along a peripheral seam to make a fluid tight compartment.
  • Panel ports are attached to the container on a panel and are often centrally disposed.
  • the panel port extends perpendicularly from the face of the panel.
  • Edge ports are attached between the two panels along a peripheral seam of the container and extend in the plane of the panels.
  • Panel ports are easily installed but have a number of drawbacks.
  • panel ports by design, necessitate the use of one or more injection molded parts. These injection molded parts are costly, especially at lower production volumes.
  • Containers having panel ports also have the undesired tendency to retain a residual volume of fluid due to incomplete drainage.
  • Edge ports have a different set of design issues. Edge ports are prone to a manufacturing defect known as "channel leak.” Channel leakage occurs along the port tube and results from an incomplete seal at the position where the planar surfaces of the two panels and the rounded surface of the port tube meet. Channel leakage is more likely to occur when the container is fabricated from a sheeting material that has a high modulus, and especially when using thin layers of such a stiff material, as the material will have a tendency to crease upon folding.
  • injection molded parts are commonly used in containers constructed from biaxially oriented nylon, foil, TEFLON®, polyester, and multilayer structures containing these polymers or similar inelastic materials.
  • the injection molded parts are inserted between the panels and, in most instances, have a tapered outer profile. The purpose of the taper is to provide fillet material to the area where channel leakage is likely to occur.
  • these injection molded parts are relatively expensive, especially in low volume production.
  • edge port tubes Another design issue with edge port tubes is that a mandrel must be used to install the edge port.
  • the mandrel is inserted through an opening in the port tube, and into the fluid flow channel of the tubing.
  • the tubing and mandrel are positioned between the sidewalls of the container.
  • welding dies are used to compress the container sidewalls and tubing to seal the tubing between the sidewalls.
  • the mandrel serves several purposes.
  • the mandrel prevents the tubing interior wall from deforming.
  • the mandrel, along with the external welding dies, are precisely dimensioned to achieve the desired compression forces against the mandrel.
  • tubing material can stick to the mandrel making withdrawal of the mandrel difficult. Also, since the mandrel must be threaded through the port tube opening, the tubing segment must be of a relatively short length.
  • the present invention provides a method for connecting rounded members, such as port tubes, between planar members, such as the sheet stock of flexible containers.
  • the process provides for either sealing without the use of a mandrel or by using a mandrel that does not directly contact the interior walls of the tubing.
  • the methods disclosed can be used to seal monolayer tubing or multilayered tubing.
  • the present invention further provides a mandrel that delivers fluid under pressure to an interior surface of the tubing sidewalk
  • the pressure is applied in a radial direction and has sufficient force to cause intimate contact between the external periphery of the tubing and the inner surfaces of the container sidewall during the sealing process.
  • This method allows for sealing the tubing without collapsing the interior sidewall surfaces into contact with one another, and without having the mandrel contact the tubing sidewall in the seal area.
  • the fluid is air, but the use of liquids is also contemplated.
  • the present invention also provides a method of sealing tubing without the use of a mandrel.
  • the wall thickness to ID ratio is inversely related to the modulus of the material so that as the modulus of the material increases the required wall thickness to ID may decrease.
  • the method of the present invention provides an outer layer with a first hardness and an inner layer with a second hardness that is greater than the first hardness.
  • the inner layer can, in effect, serve as a mandrel upon which the outer layer may be compressed by the dies causing material from the outer layer to flow into interstitial spaces between the container sidewalls and exterior walls of the tubing to provide fillet material to the weld.
  • FIG. 1 is a front elevational view of a container having a pair of port tubes sealed in a perimeter edge of the container in accordance with the present invention
  • FIG. 2 is a schematic cross-sectional view of a two-layered coextruded tube in accordance with the present invention
  • FIG. 2a is a cross-sectional view of a three-layered coextruded tube in accordance with the present invention
  • FIG. 2b is a cross-sectional view of a monolayer tubing in accordance with the present invention
  • FIG. 3 is a cross-sectional view showing the port tube in a perimeter edge of the container between flat welding dies that are open;
  • FIG. 4 is a cross-sectional view of the port tube of FIG. 3 wherein the dies are partially closed;
  • FIG. 5 is a cross-sectional view of the port tube of FIG. 3 wherein the dies are closed;
  • FIG. 6 is a schematic view of a fluid administration set
  • FIG. 7 is a schematic view of a mandrel in accordance with the present invention.
  • FIG. 8 is a diagrammatic view of a method for attaching a dispensing tube to a flexible container
  • FIG. 9 is a schematic view of another embodiment of the mandrel of the present invention.
  • FIG. 10 is an end view of another embodiment of a mandrel of the present invention. Best Mode for Carrying Out the Invention
  • FIG. 1 shows a container assembly, such as a flexible container, generally designated by the reference numeral 10.
  • the assembly 10 includes a flexible container 12 having port or dispensing tubes 14 sealed in a perimeter edge of the container 12.
  • the container 12 includes a pair of facing planar members or sidewalls 16, which are joined at their perimeter edges 18 (FIGS. 1 and 3) to define a fluid compartment 23 therebetween.
  • the planar members 16 can be constructed from a number of different materials including poly vinyl chloride, polyolefins, polyolefm copolymers, polyolefm alloys and blends, polyamides, polyesters and other materials as will be described in greater detail below.
  • FIG. 2 shows a multilayered port tubing 14, including a first or outer layer 20 and a second or inner layer 22 and a fluid passageway 25.
  • the outer layer is a thermoplastic polymer that has a tan delta measured in accordance with ASTM No. D 4065-95 from 0-0.08, more preferably from 0.02-0.075 and most preferably from 0.03-0.06 or any combination or subcombination of ranges therein.
  • Suitable thermoplastic polymers include polyolefins having a tan delta as set forth above.
  • the thermoplastic polymer is an ethylene «-olefin copolymer wherein the «-olefin comonomer has less than 12 carbons.
  • the ethylene copolymer is an ultra-low density polyethylene (ULDPE) having a density of from about 0.880-0.910 g/cm 3 and most preferably are produced using a metallocene catalyst system.
  • ULDPE ultra-low density polyethylene
  • Such a catalyst is said to be a "single site” catalyst because it has a single sterically and electronically equivalent catalyst position as opposed to the Ziegler-Natta type catalyst which are known to have a mixture of catalyst sites.
  • metallocene catalyzed ethylene ⁇ -olefins are sold by Dow under the tradename AFFINITY, and by Exxon under the tradename EXACT.
  • the inner layer 22 has sufficient resistance to compression to act as a mandrel.
  • the inner layer 22 of the tubing 14 should be composed of polyolefins, polyolefm copolymers, polyolefm alloys, polyamides, polyesters, and polyvinyl chloride (PVC) and block copolymers, for example polyester-polyether block copolymers such as those sold under the trademark HYTREL®.
  • the inner layer 22 is composed of polyvinyl chloride or a blend containing polyester-polyether block copolymers, which are capable of being bonded using solvent bonding techniques.
  • Figure 2b shows a monolayer tubing of the present invention.
  • the monolayer tubing may be of the same materials as set forth above for the outer layer 20 of the multilayered tubing.
  • a material of Shore A hardness of 70 it is critical for the monolayer tubing to have a ratio of wall thickness to inner diameter dimension that is greater than 0.20 and more preferably greater than or equal to 0.25.
  • Monolayer tubings of these types of materials having these critical dimensions allow for the inner portion of the tubing to remain in a solid phase and to act, in effect, as a mandrel while allowing the sealing portion of the tubing to flow upon applying heat and compression.
  • the tubing 14 may be sealed to the planar members 16 using any energy source which causes melting of the sealing layers or sealing portion of a monolayer tubing to form a weld between the tubing 14 and the planar members 16.
  • energy sources may be applied through, but not limited to, impulse welding equipment, constant temperature equipment, or by induction welding techniques such as radio frequency. Any of these sealing energies whether causing heating through induction or conduction shall be collectively referred to as sealing energies.
  • Disposing of the use of a mandrel is significant for several reasons including that it adds flexibility to the manufacturing steps for connecting a fluid administration set 26 (FIG. 6) to a flexible container.
  • a mandrel limits the length of a port or dispensing tube as the mandrel must be inserted through a distal end of the tubing 14 into the fluid passageway 25 and into an area where the tubing 14 is sealed to the planar members 16. It is not practical to insert a mandrel through a long length of tubing of an administration set 26.
  • disposing of the need for a mandrel allows the tubing 14 to be of a standard length of a port-tube of 0.375-1.0 inches as shown in Figure 1, or extend from the container 12 to some distal site and serve as a fluid administration set 26 as shown in FIG. 6.
  • disposing of a mandrel alleviates the problems caused when the tubing sticks to the mandrel.
  • a fluid supply line which can be used to pressurize the fluid passageway 25 of the tubing to, in effect, function as a mandrel.
  • a mandrel in a preferred form, has a generally J shape.
  • the planar members 16 may be constructed of any flexible polymeric material including PVC, polyolefins and polyolefm alloys.
  • the planar members 16 may be multilayered structures or monolayer structures.
  • the planar members 16 is a multilayered film ( Figure 8) having a core layer 80 of a vinyl alcohol copolymer; a solution contact layer 82 of a polyolefm positioned on a first side of the core layer; an outer layer 84 positioned on a second side of the core layer opposite the solution contact layer 82, the outer layer being selected from the group consisting of polyamides, polyesters and polyolefins; and, optionally, a tie layer 86 adhered to each of the first and second sides of the core layer and positioned between the solution contact layer and the core layer and between the outer layer and the core layer.
  • the core layer 14 is an ethylene vinyl alcohol copolymer having an ethylene content of from about 25-45 mole percent (ethylene incorporated, as specified in EVALCA product literature). Kuraray Company, Ltd. produces EVOH copolymers under the tradename EVAL® which have about 25-45 mole percent of ethylene, and a melting point of about 150-195°C. Most preferably the EVOH has a ethylene content of 32 mole percent.
  • the outer layer preferably is a polyamide, polyester, polyolefm or other material that aids in the transport of water away from the core layer.
  • Acceptable polyamides include those that result from a ring-opening reaction of lactams having from 4-12 carbons. This group of polyamides therefore includes nylon 6, nylon 10 and nylon 12. Most preferably, the outer layer is a nylon 12.
  • Acceptable polyamides also include aliphatic polyamides resulting from the condensation reaction of di-amines having a carbon number within a range of 2-13, aliphatic polyamides resulting from a condensation reaction of di-acids having a carbon number within a range of 2-13, polyamides resulting from the condensation reaction of dimer fatty acids, and amide containing copolymers.
  • suitable aliphatic polyamides include, for example, nylon 66, nylon 6J0 and dimer fatty acid polyamides.
  • Suitable polyesters for the outer layer include polycondensation products of di- or polycarboxylic acids and di or poly hydroxy alcohols or alkylene oxides.
  • the polyesters are a condensation product of ethylene glycol and a saturated carboxylic acid such as ortho or isophthalic acids and adipic acid. More preferably the polyesters include polyethyleneterphthalates produced by condensation of ethylene glycol and terephthalic acid; polybutyleneterephthalates produced by a condensations of 1 ,4-butanediol and terephthalic acid; and polyethyleneterephthalate copolymers and polybutyleneterephthalate copolymers which have a third component of an acid component such as phthalic acid, isophthalic acid, sebacic acid, adipic acid, azelaic acid, glutaric acid, succinic acid, oxalic acid, etc.; and a diol component such as 1,4-cyclohexanedimethanol, diethyleneglycol, propyleneglycol, etc., and blended mixtures thereof.
  • an acid component such as phthalic acid, isophthalic acid, sebacic acid, a
  • Suitable polyolefins for the outer layer are preferably selected from homopolymers and copolymers of polyolefins.
  • Suitable polyolefins are selected from the group consisting of homopolymers and copolymers of alpha-olefins containing from 2 to about 20 carbon atoms, and more preferably from 2 to about 10 carbons. Therefore, suitable polyolefins include polymers and copolymers of propylene, ethylene, butene-1, pentene-1, hexene-1, heptene-1, octene-1, nonene-1 and decene-1.
  • Suitable polyolefins further include lower alkyl and lower alkene acrylates and acetates and ionomers thereof.
  • lower alkyl means alkyl groups having 1-5 carbon atoms such as ethyl, methyl, butyl and pentyl.
  • ionomer is used herein to refer to metal salts of the acrylic acid copolymers having pendent carboxylate groups associated with monovalent or divalent cations such as zinc or sodium.
  • the inner layer is selected from ethylene ⁇ -olefin copolymers especially ethylene-butene-1 copolymers which are commonly referred to as ultra-low density polyethylenes (ULDPE).
  • ULDPE ultra-low density polyethylenes
  • the ethylene -olefin copolymers are produced using metallocene catalyst systems.
  • Suitable metallocene catalyzed ethylene ⁇ -olefins are sold by Dow under the tradename AFFINITY, and by Exxon under the tradename EXACT.
  • the ethylene ⁇ -olefins preferably have a density from 0.880- 0.910 g/cc.
  • Suitable tie layers include modified polyolefins blended with unmodified polyolefins.
  • the modified polyolefins are typically polyethylene or polyethylene copolymers.
  • the polyethylenes can be ULDPE, low density (LDPE), linear low density (LLDPE), medium density polyethylene (MDPE), and high density polyethylenes (HDPE).
  • the modified polyethylenes may have a density from 0.850- 0.95 g/cc.
  • the polyethylene may be modified by grafting with carboxylic acids, and carboxylic anhydrides.
  • Suitable grafting monomers include, for example, maleic acid, fumaric acid, itaconic acid, citraconic acid, allylsuccinic acid, cyclohex-4-ene-l ,2- dicarboxylic acid, 4-methylcyclohex-4-ene-l,2-dicarboxylic acid, bicyclo[2.2J]hept- 5-ene-2,3-dicarboxylic acid, x-methylbicyclo[2.2J]hept-5-ene-2,3-dicarboxylic acid, maleic anhydride, itaconic anhydride, citraconic anhydride, allylsuccinic anhydride, citraconic anhydride, allylsuccinic anhydride, cyclohex-4-ene-l,2-dicarboxylic anhydride, 4-methylcyclohex-4-ene-l,2-dicarboxylic anhydr
  • Examples of other grafting monomers include C,-C 8 alkyl esters or glycidyl ester derivatives of unsaturated carboxylic acids such as methyl acrylate, methyl methacrylate, ethyl acrylate, ethyl methacrylate, butyl acrylate, butyl methacrylate, glycidyl acrylate, glycidyl methacrylate, monoethyl maleate, diethyl maleate, monomethyl maleate, diethyl maleate, monomethyl fumarate, dimethyl fumarate, monomethyl itaconate, and diethylitaconate; amide derivatives of unsaturated carboxylic acids such as acrylamide, methacrylamide, maleicmonoamide, maleic diamide, maleic N-monoethylamide, maleic N,N-diethylamide, maleic N- monobutylamide, maleic N,N dibutylamide, fumaric monoamide, fumaric diamide,
  • the unmodified polyolefins can be selected from the group consisting of ULDPE, LLDPE, MDPE, HDPE and polyethylene copolymers with vinyl acetate and acrylic acid.
  • Suitable modified polyolefm blends are sold, for example, by DuPont under the tradename BYNEL®, by Chemplex Company under the tradename PLEXAR®, and by Quantum Chemical Co. under the tradename PREXAR.
  • Planar members 16 may also be multilayered or monolayer structures fabricated from the polyolefm alloys disclosed in commonly assigned U.S. Patent No. 5,686,527 which is incorporated herein by reference and made a part hereof.
  • multiple component polymer alloys such as a 3-5 component polymer alloys that are RF responsive or RF susceptible.
  • RF susceptible is that the material will have a dielectric loss when excited with a signal having a frequency between 1 and 60 MHz, and between the temperature range of 25-250 °C, greater than or equal to 0.05 and more preferably greater than or equal to OJ
  • the first component will confer heat resistance and flexibility to the composition.
  • This component may be selected from the group consisting of amorphous polyalpha olefins and preferably is a flexible polyolefm. These polyolefins should resist distortions to high temperatures up to 121 °C, having a peak melting point of greater than 130°C and be highly flexible, having a modulus of not more than 20,000 psi.
  • a flexible polyolefm is sold under the product designation Rexene FPO 90007 which has a peak melting point of 145° C and a modulus of 11,000 psi.
  • certain polypropylenes with high syndiotacticity also posses the properties of high melting point and low modulus.
  • the first component should constitute from 40-90% by weight of the composition.
  • the second component of the three component composition is an RF susceptible polymer which confers RF sealability to the composition and may be selected from either of two groups of polar polymers.
  • the first group consists of ethylene copolymers having 50-85% ethylene content with at least one comonomer selected from the group consisting of acrylic acid, methacrylic acid, ester derivatives of acrylic acid with alcohols having 1-10 carbons, ester derivatives of methacrylic acid with alcohols having 1-10 carbons, vinyl acetate, and vinyl alcohol.
  • the RF susceptible polymer may also be selected from a second group consisting of polymers and copolymers containing at least one monomer or segment of urethane, ester, urea, imide, sulfone, and amide.
  • the RF susceptible polymer should constitute by weight from 5-50% of the composition.
  • the RF component is copolymers of ethylene methyl acrylate with methyl acrylate within the range of 15-25% by weight of the polymer.
  • the final component of the three component compound confers compatibility between the first two components, and is selected from a styrene and hydrocarbon block copolymer and more preferably a styrene-ethylene-butene-styrene block (SEBS) copolymer, styrenic block copolymers and most preferably SEBS block copolymer that is maleic anhydride functionalized.
  • SEBS styrene-ethylene-butene-styrene block
  • the first component confers RF sealability and flexibility over the desired temperature range.
  • the first component confers high temperature resistance ("temperature resistant polymer") and is chosen from the group consisting of polyamides, polyimides, polyurethanes, polypropylene, and polymethylpentene.
  • temperature resistant polymer is chosen from the group consisting of polyamides, polyimides, polyurethanes, polypropylene, and polymethylpentene.
  • the first component constitutes by weight within the range of 30-60% of the composition, and preferably is polypropylene.
  • the second component confers RF sealability and flexibility over the desired temperature range.
  • the RF polymer is selected from the first and second groups identified above with the exception of ethylene vinyl alcohol.
  • the second component should constitute by weight within the range of 30-60% of the composition.
  • the third component ensures compatibility between the first two components and is chosen from SEBS block copolymers and preferably is maleic anhydride functionalized.
  • the third component should constitute by weight within the range
  • the first component confers heat resistance.
  • This component may be chosen from polyolefins, most preferably polypropylenes, and more specifically the propylene alpha-olefin random copolymers (PPE).
  • PPE propylene alpha-olefin random copolymers
  • the PPE's will have a narrow molecular weight range. However, by themselves, the PPE's are too rigid to meet the flexibility requirements. When combined by alloying with certain low modulus polymers, good flexibility can be achieved. Examples of acceptable PPE's include those sold under the product designations Soltex 4208, and Exxon Escorene PD9272.
  • low modulus copolymers can include ethylene based copolymers such as ethylene vinyl acetate (“EVA”), ethylene co-alpha olefins, or the so-called ultra low density (typically less than 0.90Kg/L) polyethylenes (“ULDPE”).
  • EVA ethylene vinyl acetate
  • ULDPE ultra low density polyethylenes
  • TAFMER® Mitsubishi Chemical Co.
  • EXACT® Exxon Chemical Company
  • product designations 4023-4024 trademarks 4023-4024
  • INSITE® technology polymers Low Chemical Co.
  • poly butene-1 such as those sold by Shell Chemical Company under product designations PB-8010, PB- 8310; thermoplastic elastomers based on SEBS block copolymers, (Shell Chemical Company), poly isobutene (“PIB”) under the product designations Vistanex L-80, L- 100, L-120, L-140 (Exxon Chemical Company), ethylene alkyl acrylate, the methyl acrylate copolymers (“EMA”) such as those under the product designation EMAC 2707, and DS-1130 (Chevron), and n-butyl acrylates (“ENBA”) (Quantum Chemical) were found to be acceptable copolymers.
  • PB poly butene-1
  • Ethylene copolymers such as the acrylic and methacrylic acid copolymers and their partially neutralized salts and ionomers, such as PRIMACOR® (Dow Chemical Company) and SURLYN® (E.I. DuPont de Nemours & Company) are also satisfactory.
  • the first component is chosen from the group of polypropylene homo and random copolymers with alpha olefins which constitute by weight approximately 30-60%, more preferably 35-45%, and most preferably 45%, of the composition and any combination or subcombination of ranges therein.
  • random copolymers of propylene with ethylene where the ethylene content is in an amount within the range of 1 -6%, and more preferably 2-4%, of the weight of the polymer is preferred as the first component.
  • the second component of the four component polymer alloy confers flexibility and low temperature ductility and is a second polyolefm different than that of the first component wherein it contains no propylene repeating units ("non propylene based polyolefm").
  • it is selected from the ethylene copolymers including ULDPE, polybutene, butene ethylene copolymers, ethylene vinyl acetate, copolymers with vinyl acetate contents between approximately 18-50%, ethylene methyl acrylate copolymers with methyl acrylate contents being between approximately 20-40%, ethylene n-butyl acrylate copolymers with n-butyl acrylate content of between 20- 40%, ethylene acrylic acid copolymers with the acrylic acid content of greater than approximately 15%.
  • the second component is either ULDPE sold by Mitsui Petrochemical Company under the designation TAFMER® A- 4085, or polybutene-1, PB8010 and PB8310 (Shell Chemical Co.), and should constitute by weight approximately 25-50%, more preferably 35-45%, and most preferably 45%, of the composition and any combination or subcombination of ranges therein.
  • RF susceptible polymers certain known high dielectric loss ingredients are included in the composition. These polymers may be selected from the group of RF polymers in the first and second group set forth above.
  • RF active materials include PVC, vinylidine chlorides, and fluorides, copolymer of bis-phenol-A and epichlorohydrines known as PHENOXYS® (Union Carbide).
  • the polyamides of the RF susceptible polymer are preferably selected from aliphatic polyamides resulting from the condensation reaction of di-amines having a carbon number within a range of 2-13, aliphatic polyamides resulting from a condensation reaction of di-acids having a carbon number within a range of 2- 13 , polyamides resulting from the condensation reaction of dimer fatty acids, and amides containing copolymers (random, block, and graft). Polyamides are seldom found in the layer which contacts medical solutions as they may contaminate the solution by leaching out into the solution.
  • the most preferred RF susceptible polymer are a variety of dimer fatty acid polyamides sold by Henkel Corporation under the product designations MACROMELT and VERSAMID, which do not lead to such contamination.
  • the RF susceptible polymer preferably should constitute by weight approximately 5-30%, more preferably between 7-13%, and most preferably 10%, of the composition and any combination or subcombination of ranges therein.
  • the fourth component of the composition confers compatibility among the polar and nonpolar components of the composition (sometimes referred to as a "compatibilizing polymer”) and preferably is styrenic block copolymers with hydrocarbon soft segments. More preferably, the fourth component is selected from SEBS block copolymers that are modified by maleic anhydride, epoxy, or carboxylate functionalities, and preferably is an SEBS block copolymer that contains maleic anhydride functional groups ("functionalized"). Such a product is sold by Shell Chemical Company under the designation KRATON® RP-6509.
  • the compatibilizing polymer should constitute by weight approximately 5-40%, more preferably 7-13%, and most preferably 10% of the composition and any combination or subcombination of ranges therein.
  • a fifth component of a nonfunctionalized SEBS block copolymer such as the ones sold by Shell Chemical Company under the product designations KRATON G-1652 and G-1657.
  • the fifth component should constitute by weight approximately 5-40%, and more preferably 7-13% and any combination or subcombination of ranges therein.
  • Another acceptable polymer alloy is a blend of styrene-ethylene-butene-styrene (“SEBS”) block copolymer (40%-85% by weight), ethylene vinyl acetate (0-40% by weight), and polypropylene ( 10%-40% by weight)
  • SEBS styrene-ethylene-butene-styrene
  • the multilayered or monolayer tubing 14 is constructed by an extrusion process. Other manufacturing methods can also be used to produce a tube useful with the present invention although extrusion is preferred.
  • the multilayered tubing 14 could also include additional layers, if desired.
  • the tie layer 24 may be selected from modified polyolefins, and modified ethylene and propylene copolymers, such as those sold under the product designations ADMER (Mitsui), which is a maleic anhyrdride modified polypropylene, PREXAR (Quantum Chemical Co.) and BYNEL (Dupont).
  • the tie layer 24 should be as thin as practical and have a thickness from 0.0002 inches to 0.003 inches. If additional layers are used, it remains important that the hardness of the inner layer 22 is greater than the hardness of the outer layer 20. Although less critical, it is also important that the melt softening temperature range T2 of the inner layer 22 be higher than the melt softening temperature range Tl of the outer layer 20. Although it is possible to form a seal where Tl is greater than or equal to T2 so long as the method of welding heats the outer layer to temperature Tl without heating the inner layer to temperature T2. Although a circular-shaped tubing 14 is shown in FIG. 2, other tubing could be used having other cross-sectional shapes, including oval or polygonal cross-sections.
  • the tubing 14 is compressed, without deflecting the inner layer 22 of the tubing 14 substantially out of round, using a die while applying sealing energies through the die. While the inner layer 22 is not deflected substantially out of round, the outer layer 20 of the tubing 14 is compressed.
  • the sealing process may be carried out using flat dies with an elastomeric buffer or shaped welding dies. The dies are typical of those found in industry.
  • FIG. 3 shows a pair of conventional flat, mating welding dies 32,34 used in the heat sealing process.
  • Each die 32,34 has a compressible membrane 36,38 respectively that has a modulus of elasticity less than that of the tubing.
  • An end portion 14a of the tubing 14 is positioned between the perimeter edges 18 of the pair of planar members 16 to define an interface area 26.
  • the interface area 26, as indicated by the arrows, includes the area where the planar members 16 bond to the tubing 14.
  • a portion 28 of each of the planar members 16 extends outward from the interface area 26. It is of course possible to apply sealing energies through a single die without departing from the spirit of the invention.
  • the interface area 26 is then positioned between the pair of flat welding dies 32,34.
  • the welding dies begin to close to compress the planar members 16 against the end portion 14a of the tubing 14.
  • the flexible membranes 36,38 flex around the planar members 16 and the tubing 14.
  • FIG. 5 show the welding dies 32,34 fully closed to apply pressure to the interface area 26.
  • the welding dies 32,34 also apply sealing energies, such as heat, within to raise the outer layer to temperature Tl without heating the inner layer to temperature T2.
  • the welding dies 32,34 fully close and compress the planar members 16 around the tubing 14. The outer layer 20 of the tubing 14 is compressed.
  • the inner layer 22 is not deflected substantially out of round (FIG. 5).
  • the outer layer 20 of the tube 14 begins to melt and outer portions of the outer layer 20 flow toward end members 40 of the tubing 14 to supply additional material or fillet material to the weld formed in the interface area 26. This improves the weld between the rounded members 40 and the perimeter edges 18 and further reduces the likelihood of channel leakage.
  • the outer layer 20 of the tubing 14 and perimeter edges 18 of the planar members 16 soften and melt together at the interface area 26.
  • the planar members 16 are welded around an entire periphery of the end portion 14a of the tubing 14. Compressive forces are continually applied until the dies 32,34 contact the portion 28 of the planar members, which linearly extend beyond the interface area 26, and are welded to each other as well (FIG. 5).
  • the welding dies 32,34 are opened, thereby releasing the pressure to the interface area 26. Because the sealing energy is applied ⁇ c that the inner layer inner layer 22 does not reach temperature T2, the inner layer 22 does not melt. Regardless, because the inner layer 22 is not collapsed to a flattened position during the welding process, there is no chance of welding the inner 22 to itself. After the pressure is released, the tube 14 returns to a substantially rounded configuration to provide a pathway for the contents stored in the container. An improved weld is provided by compressing the tubing 14 between the planar members 16 at the time of sealing and melting a portion of the outer layer 20 of the tube 14.
  • sealing energy is continually applied to the interface area 26 and pressure is applied to the compressed tubing 14
  • the outer layer 20 of the tubing 14 continues to melt, allowing a portion of the outer layer 20 to flow and provide fillet material to the weld in the interface area 26.
  • This further improves the seal between the outer layer 20 and the planar members 16 because material can flow to fill any voids or gaps present between the outer layer 20 and planar members 16. It should be understood that it is possible to apply sealing energy to a die prior to collapsing the tube 14 or afterward depending on the welding techniques being used.
  • the same dies and process described above for sealing multilayered tubing may also be used to seal the monolayer tubing shown in Figure 2b.
  • the dies supply heat to the tubing to melt soften the sealing portion 90 (Figure 7) of the tubing while the inner portion 92 remains in a relatively solid state.
  • the melt softened sealing portion 90 flows along the relatively unsoftened inner portion 92 of the tubing to provide fillet material to the weld area.
  • a J-shaped fluid supply line 100 (Figure 7) is employed in the sealing process ( Figure 8).
  • the fluid supply line 100 functions as a mandrel, but without requiring an exterior surface 102 of the supply line 100 to directly contact the tubing sidewall in the interface area 26.
  • the fluid supply line 100 which shall be referred to hereafter as mandrel 100, has a descending leg 104, a horizontal leg 106, an ascending leg 108, a fluid entry port 110, a fluid exit port 112 and a fluid passageway 114 connecting the entry and exit ports.
  • An exterior surface proximate the fluid exit port 112 tapers 118 to a reduced diameter to fit within the fluid passageway 25 of the tubing.
  • the mandrel 100 delivers air under pressure to fluid entry port 110 while a portion of the tubing is crimped 111 either partially or completely to provide axially directed pressure to inflate the tubing sidewalls into contact with the sealing dies 32, 34.
  • the air should be supplied under pressure within the range of approximately 20-40 psi, more preferably from 25-35 psi and most preferably from 27-31 psi or any range or subcombination of ranges therein.
  • the second fluid passageway 120 can be mounted in horizontal or vertical spaced relationship or mounted coaxially.
  • the air escape passages 122 assist in regulating the pressure supplied to the tubing.
  • the air escape passage 122 can also be provided, as shown in Figure 10, by positioning a vent 123 in the outer surface of the mandrel.
  • the method of using the mandrel 100 in sealing tubing includes the steps of positioning an end portion of the tubing between perimeter edges of the pair of planar members 16 to define an interface area 26, inserting the fluid discharge port of the mandrel into the entry port of the rounded member and into the fluid passageway, supplying fluid under pressure through the mandrel 100 into the fluid passageway of the tubing to supply a radially directed force to the inner surface of the sidewall of the tubing to inflate the tubing, and applying sealing energy to the interface area 26 with the welding die to heat the tubing to a temperature sufficient to soften a portion of the rounded member forming a weld between the planar members and the tubing in the interface area.
  • the hot welding die 130 can be applied first to create a weld and the cold welding die 132 can be shuttled to cool the interface area 26.
  • Example 1- a monolayer tubing of ULDPE (Dow PL 8180) was extruded having an inner diameter of 0.375 inches an outer diameter of 0.438, a wall thickness of 0.031 inches and a wall to inner diameter ratio of 0.07.
  • the monolayer tubing was attached between sidewalls of a multilayer sheeting material having a core layer 80 of an ethylene vinyl alcohol copolymer having an ethylene content of 32 mole percent, an outer layer of nylon 12 and an inner layer of ULDPE.
  • Tie layers of BYNEL were interposed between the core and outer layer and between the core and inner layers.
  • the monolayer tubing was inserted between the sheeting material and supplied with 30 psi of pressurized air while a shaped die was closed about the tubing.
  • Example 2-a multilayered tubing was fabricated by coextruding an outer layer of ULDPE (Dow PL 8180) onto an inner layer of PVC (PL 1847). The multilayered tubing was welded to the sheeting material described in Example 1 and tested for channel leakage as described in Example 1. No channel leakage was observed.
  • Example 3- a monolayer tubing of ULDPE (Dow PL 1880) was extruded having an inner diameter of 0J 88 inches an outer diameter of 0.375, a wall thickness of 0.094 inches and a wall to inner diameter ratio of 0.25.
  • the monolayer tubing was attached between sidewalls of a multilayer sheeting material having a core layer 80 of an ethylene vinyl alcohol copolymer having an ethylene content of 32 mole percent, an outer layer of nylon 12 and an inner layer of ULDPE. Tie layers of BYNEL were interposed between the core and outer layer and between the core and inner layers.
  • the monolayer tubing was inserted between the sheeting material while a shaped die was closed about the tubing.
  • the sheeting material was sealed on four sides to form a fluid tight pouch. The pouch was filled with water and no channel leakage was observed.

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Abstract

La présente invention concerne un procédé permettant de sceller un élément arrondi (14) doté d'un premier passage de fluide (25) définissant un diamètre intérieur dudit élément, entre deux éléments plans (16). Ce procédé consiste à placer l'élément arrondi entre les éléments plans (16), définissant ainsi une zone d'interface (26); à fournir un fluide sous pression au premier passage de fluide (25); et à chauffer la zone d'interface (26) pour créer une soudure entre l'élément arrondi (14) et les éléments plans (16).
PCT/US2000/001163 1999-01-22 2000-01-18 Procede de scellage d'un tube dans un contenant WO2000043189A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
KR1020017008626A KR20010111092A (ko) 1999-01-22 2000-01-18 용기 내의 튜브 밀봉 방법
BR0007824A BR0007824A (pt) 1999-01-22 2000-01-18 Processo de vedação de um tubo em um recipiente
EP00904398A EP1135246A4 (fr) 1999-01-22 2000-01-18 Procede de scellage d'un tube dans un contenant
CA 2358653 CA2358653A1 (fr) 1999-01-22 2000-01-18 Procede de scellage d'un tube dans un contenant
AU26164/00A AU764318B2 (en) 1999-01-22 2000-01-18 Method of sealing a tube in a container
JP2000594631A JP2002535162A (ja) 1999-01-22 2000-01-18 チューブを容器に密封する方法

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US09/235,868 1999-01-22

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FR2833483A1 (fr) * 2001-12-17 2003-06-20 Technoflex Ind Embout perfuseur pour poche souple a usage medical
WO2004026961A2 (fr) * 2002-09-20 2004-04-01 Baxter International Inc. Element de raccordement permettant de relier des materiaux dissemblables
WO2004113106A1 (fr) * 2003-06-20 2004-12-29 Peugeot Citroen Automobiles Procede et dispositif de mise en pression d'une feuille d'etancheite sur un element de carrosserie
WO2005042232A1 (fr) * 2003-10-30 2005-05-12 3L Ludvigsen A/S Soudage a un tube
WO2008130324A1 (fr) * 2007-04-24 2008-10-30 Uswe International Ab Système de liquide mobile
WO2010058051A1 (fr) * 2008-11-18 2010-05-27 Volpak, S.A.U. Procédé et mâchoire pour le scellage par thermosoudure des bords terminaux de deux parois latérales d'un emballage souple sur un corps de support d'une embouchure
WO2017075022A1 (fr) * 2015-10-30 2017-05-04 Dow Global Technologies Llc Procédé de scellage d'un accessoire flexible sur un film flexible

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KR100462056B1 (ko) * 2002-01-22 2004-12-16 부영필 환경친화적인 배뇨용기를 제조하는 장치 및 방법
DE10313760B3 (de) * 2003-03-27 2004-06-03 Fresenius Kabi Deutschland Gmbh Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten
JP5243064B2 (ja) * 2008-03-03 2013-07-24 テルモ株式会社 医療用容器
US10155615B2 (en) * 2016-09-26 2018-12-18 Dow Global Technologies Llc Seal bar and process for using same

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FR2833483A1 (fr) * 2001-12-17 2003-06-20 Technoflex Ind Embout perfuseur pour poche souple a usage medical
WO2003051270A3 (fr) * 2001-12-17 2003-12-11 Technoflex Ind Embout perfuseur pour poche souple a usage medical
WO2004026961A2 (fr) * 2002-09-20 2004-04-01 Baxter International Inc. Element de raccordement permettant de relier des materiaux dissemblables
WO2004026961A3 (fr) * 2002-09-20 2004-09-02 Baxter Int Element de raccordement permettant de relier des materiaux dissemblables
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WO2017075022A1 (fr) * 2015-10-30 2017-05-04 Dow Global Technologies Llc Procédé de scellage d'un accessoire flexible sur un film flexible
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US10668670B2 (en) 2015-10-30 2020-06-02 Dow Global Technologies Llc Process for sealing flexible fitment to flexible film
CN107787272B (zh) * 2015-10-30 2020-09-01 陶氏环球技术有限责任公司 将柔性设备密封到柔性膜的方法

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EP1135246A4 (fr) 2003-09-24
BR0007824A (pt) 2002-09-10
JP2002535162A (ja) 2002-10-22
AU764318B2 (en) 2003-08-14
AU2616400A (en) 2000-08-07
EP1135246A1 (fr) 2001-09-26
CA2358653A1 (fr) 2000-07-27
KR20010111092A (ko) 2001-12-15

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