EP0113758A1 - Systeme sterile de transfert de fluide et dispositif associe de transfert de fluide a acces multiples - Google Patents

Systeme sterile de transfert de fluide et dispositif associe de transfert de fluide a acces multiples

Info

Publication number
EP0113758A1
EP0113758A1 EP83902378A EP83902378A EP0113758A1 EP 0113758 A1 EP0113758 A1 EP 0113758A1 EP 83902378 A EP83902378 A EP 83902378A EP 83902378 A EP83902378 A EP 83902378A EP 0113758 A1 EP0113758 A1 EP 0113758A1
Authority
EP
European Patent Office
Prior art keywords
fluid transfer
ports
fluid
multiple access
closure means
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.)
Withdrawn
Application number
EP83902378A
Other languages
German (de)
English (en)
Inventor
Daniel R. Boggs
Daniel B. Granzow
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.)
Baxter International Inc
Original Assignee
Baxter Travenol Laboratories 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 Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc
Publication of EP0113758A1 publication Critical patent/EP0113758A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • B29C65/14Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/1429Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the way of heating the interface
    • B29C65/1435Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the way of heating the interface at least passing through one of the parts to be joined, i.e. transmission welding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04Heat
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08Radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/14Tube connectors; Tube couplings for connecting tubes having sealed ends
    • A61M39/143Tube connectors; Tube couplings for connecting tubes having sealed ends both tube ends being sealed by meltable membranes pierced after connection by use of heat, e.g. using radiant energy
    • 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
    • B29C65/14Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/1429Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the way of heating the interface
    • B29C65/1464Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation characterised by the way of heating the interface making use of several radiators
    • 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
    • B29C65/56Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits
    • B29C65/58Snap connection
    • 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
    • B29C65/74Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area
    • B29C65/747Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area using other than mechanical means
    • B29C65/7473Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by welding and severing, or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area using other than mechanical means using radiation, e.g. laser, for simultaneously welding and severing
    • 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
    • B29C66/12Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections
    • B29C66/122Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section
    • B29C66/1222Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a lapped joint-segment
    • 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
    • B29C66/12Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections
    • B29C66/122Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section
    • B29C66/1224Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a butt joint-segment
    • 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
    • B29C66/137Beaded-edge joints or bead seals
    • 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
    • B29C66/534Joining single elements to open ends of tubular or hollow articles or to the ends of bars
    • 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
    • B29C66/534Joining single elements to open ends of tubular or hollow articles or to the ends of bars
    • B29C66/5346Joining single elements to open ends of tubular or hollow articles or to the ends of bars said single elements being substantially flat
    • B29C66/53465Joining single elements to open ends of tubular or hollow articles or to the ends of bars said single elements being substantially flat said single flat elements being provided with holes facing the tube ends, e.g. for making heat-exchangers
    • 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
    • B29C66/73General 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
    • B29C66/737General 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 state of the material of the parts to be joined
    • B29C66/7377General 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 state of the material of the parts to be joined amorphous, semi-crystalline or crystalline
    • B29C66/73775General 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 state of the material of the parts to be joined amorphous, semi-crystalline or crystalline the to-be-joined area of at least one of the parts to be joined being crystalline
    • B29C66/73776General 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 state of the material of the parts to be joined amorphous, semi-crystalline or crystalline the to-be-joined area of at least one of the parts to be joined being crystalline the to-be-joined areas of both parts to be joined being crystalline
    • 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
    • B29C66/73General 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
    • B29C66/739General 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
    • B29C66/7392General 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
    • B29C66/73921General 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
    • 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
    • B29C66/84Specific machine types or machines suitable for specific applications
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    • AHUMAN NECESSITIES
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    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1027Quick-acting type connectors
    • AHUMAN NECESSITIES
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    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1083Tube connectors; Tube couplings having a plurality of female connectors, e.g. Luer connectors
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C35/02Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
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    • B29C35/0805Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using electromagnetic radiation
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
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    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/14Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
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    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
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    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
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    • 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
    • B29C66/73General 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
    • B29C66/733General 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 optical properties of the material of the parts to be joined, e.g. fluorescence, phosphorescence
    • B29C66/7336General 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 optical properties of the material of the parts to be joined, e.g. fluorescence, phosphorescence at least one of the parts to be joined being opaque, transparent or translucent to visible light
    • B29C66/73361General 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 optical properties of the material of the parts to be joined, e.g. fluorescence, phosphorescence at least one of the parts to be joined being opaque, transparent or translucent to visible light at least one of the parts to be joined being opaque to visible light
    • 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
    • B29C66/73General 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
    • B29C66/733General 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 optical properties of the material of the parts to be joined, e.g. fluorescence, phosphorescence
    • B29C66/7336General 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 optical properties of the material of the parts to be joined, e.g. fluorescence, phosphorescence at least one of the parts to be joined being opaque, transparent or translucent to visible light
    • B29C66/73365General 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 optical properties of the material of the parts to be joined, e.g. fluorescence, phosphorescence at least one of the parts to be joined being opaque, transparent or translucent to visible light at least one of the parts to be joined being transparent or translucent to visible light
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING 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
    • B29K2995/00Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0018Properties of moulding materials, reinforcements, fillers, preformed parts or moulds having particular optical properties, e.g. fluorescent or phosphorescent
    • B29K2995/0025Opaque
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING 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
    • B29K2995/00Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0018Properties of moulding materials, reinforcements, fillers, preformed parts or moulds having particular optical properties, e.g. fluorescent or phosphorescent
    • B29K2995/0026Transparent
    • B29K2995/0027Transparent for light outside the visible spectrum

Definitions

  • This invention generally relates to systems and devices which serve to transfer fluids, and, in particular, systems and devices Which transfer fluids in a sterile manner.
  • This invention also generally relates to systems and devices which serve to intermix, or compound, fluids.
  • a fluid network is one associated with peritoneal dialysis.
  • dialy ⁇ ate is transferred directly into the peritoneal cavity of a patient. After about 3 to 4 hours, the dialysate is drained from the peritoneal cavity and replaced with fresh dialysate.
  • This procedure requires a multiplicity of connections to be made on a daily basis to introduce and remove the dialysate.
  • each connection must be made in as sterile a manner as possible.
  • gloves, masks, gauze strips, and disinfectant solutions are typically employed. However, since these precautions often prove cumbersome and inconvenient, they are subject to neglect and human error.
  • fluid networks involving multiple connections include those associated with chemical compounding and solution formulation. These include fluid networks which enable the compounding and infusion of medicines, pharmaceuticals, parenteral fluids, blood and blood components, and the like into the human body.
  • a more specific example of this type of network is one involved in the compounding of hyperalimentation solutions.
  • Hyperalimentation therapy includes the intravenous feeding of a protein-carbohydrate mixture when the patient's protein and caloric requirements cannot be otherwise satisfied by oral feeding.
  • the protein may consist of a free-amino acid or protein hydrolysate, and the carbohydrate can include dextrose. Vitamins and electrolytes can also be included in the protein-carbohydrate mixture. It is, of course, desirable that these mixtures be administered to the patient in a sterile condition.
  • parenteral ingredients are particularly susceptible to the growth of deleterious organisms.
  • hyperalimentation solutions cannot always be compounded by the manufacturer. Rather, they must be compounded in a sterile manner at the time of their use, for example, by a hospital pharmacist.
  • these solutions are compounded under a device known as a laminar flow hood.
  • This device operates by taking room air and passing it through a prefilter to remove airborne contaminants (such a dust and lint). The air is then compressed and channeled through bacterial retentive filter in the hood to remove all bacteria from the air.
  • i-t is another one of the principal objects of this invention to provide a fluid transfer device and system which permits the formation, without reliance upon a laminar flow hood and the like, of multiple component solutions in a manner which does not breach the sterile integrity of any of the component ingredients or of the formed solution itself.
  • the invention provides a fluid transfer device which enables a multiplicity of sterile connections to be made quickly and virtually in a foolproof manner.
  • the device which embodies the features of the invention includes a body having wall means which defines a hollow interior. Entry means is provided for defining at least two ports in the wall means. Means is provided for selectively attaching the end portion of a fluid conduit in communication with each of the ports. A flow of fluid into and through the hollow interior of the device can thus be established.
  • the device further includes closure means which extends across each of the ports and which normally seals the ports from communication with the atmosphere. Once sterilized, the sterile integrity of the interior of the device can thus be maintained.
  • each of the closure means is removable to open the associated port.
  • removal of each of the closure means requires an active sterilization step which serves to sterilize the fluid path formed through the port.
  • an active sterilization step accompanies the establishment of fluid communication into and through the device.
  • the closure means is made of a material which melts in response to exposure to a source of radiant energy and at temperatures which result in the rapid destruction of any bacterial contamination on the surface of the material.
  • the wall means of the body is preferably made of a material which is generally nonabsorbent of, and thus transparent to, the radiant energy used to melt the closure means. The wall means material thus passes the radiant energy without itself being heated to any great extent. This arrangement also promotes a fast and efficient transfer of radiant heat to melt the closure means.
  • the wall means includes at least two diametrically spaced walls.
  • the entry means includes a plurality of ports in each of the diametrically spaced walls, each port being sealed by the meltable closure means. A multiplicity of connections can thus be accommodated upstream and downstream of the intended fluid flow path through the device.
  • the axis of each of the ports defined in one of the spaced walls is preferably laterally spaced from the axis of each of the ports defined in the other one of the spaced walls.
  • the energy used to melt the closure means can be easily focused through one wall upon a selected closure means defined in an opposite wall.
  • the invention also provides a fluid transfer assembly which includes the multiple access transfer device heretofore defined.
  • the conduit attachment means of the device includes connector means which is attachable to the end of a fluid conduit and which is operative for engagement with each of the ports defined in the wall means.
  • the connector means includes closure means which normally seals each conduit end portion and which is removable only in conjunction with an active sterilization step.
  • the closure means of the port and the closure means of the connector means are held in facing contact.
  • the facing closure means are further operative for jointly melting to form a fluid path through the facing portions, but only in response to exposure to sterilizing temperatures.
  • an active sterilization step occurs simultaneously with the formation of the fluid path.
  • the invention also provides a sterile fluid transfer system which includes a multiple access fluid transfer assembly as heretofore defined.
  • the system also includes at least one source of fluid and at least one fluid receiving receptable.
  • one connector means of the fluid transfer assembly communicates with the fluid source and the receiving receptacle.
  • Fig. 1 is a perspective view, with portions broken away, of a multiple access fluid transfer assembly which embodies the features of the invention
  • Fig. 2 is a partial section view generally taken along line 2-2 in Fig. 1 and which shows the multiple access fluid transfer device and connector means which together comprise the assembly shown in Fig. 1
  • Fig. 3 is an enlarged section view of the multiple access fluid transfer assembly shown in Fig. 2 with the connector means coupled to the transfer device and being exposed to a source of radiant energy to open a fluid path therethrough
  • Fig. 4 is an enlarged section view of the assembly shown in Fig. 3 after the fluid path has been opened between the connector means and the transfer device;
  • Fig. 5 is a sterile fluid transfer system which includes the fluid transfer assembly which is shown in Fig. 1;
  • Fig. 6 is a sterile fluid transfer system which includes another embodiment of a multiple access fluid transfer assembly which embodies the features of the invention.
  • a multiple access fluid transfer device 10 is shown in Fig. 1.
  • the device includes a body 12 having wall means 14 which defines a hollow interior 16.
  • the device 10 also includes entry means which defines at least two access ports 20 in the wall means 14.
  • the ports 20 open the hollow interior 16 of the device 10 to communication with the atmosphere.
  • the device 10 also includes means 22 which accommodates the attachment of the end portion of a conduit 24 in fluid communication with any of the ports 20. Fluid flow into and through the hollow interior 16 of the device 10 can thus be established.
  • the body 12 of the device 10 may be variously constructed.
  • the body 12 constitutes an injection molded plastic part.
  • the device 10 takes the form of a generally rectangular box.
  • the wall means 14 includes three pairs of diametrically spaced walls 15 (i.e., a total of six walls 15) which collectively define the hollow interior 16.
  • the ports 20 are formed only in a selected pair of the diametrically spaced walls 15.
  • these walls when the device 10 is positioned as shown in Fig. 1, these walls constitute the top, or upstream, wall (designated 15a in Fig. 1) and the bottom, or downstream, wall (designated 15b in Fig. 1) of the device 10.
  • Such an arrangement facilitates the gravity flow of fluids into and through the device 10.
  • the number of ports 20 can vary according to the intended function of the device 10. In the illustrated embodiment, a plurality of ports 20 are associated with each of the selected pair of walls 15a and b.
  • the device 10 further includes closure means 26 which extends across each of the ports 20 to normally seal the ports 20.
  • closure means 26 which extends across each of the ports 20 to normally seal the ports 20.
  • the hollow interior 16 of the device 10 is thus normally sealed by the closure means 26 from communication with the atmosphere.
  • Each of the closure means 26 is selectively removable to open a fluid path through the associated port 20.
  • the closure means 26 may be variously constructed and employ different means of operation. However, to meet the desired objectives of the invention, the closure means 26 must (1) normally close each port 20 from communication with the atmosphere, and (2) be removable only in conjunction with an active sterilization step which serves to sterilize the regions adjacent to the fluid path through each port 20 as the port 20 is opened. It has been determined that the closure means associated with the connector described in Granzow et al U.S. Patents 4,157,723 and 4,265,280 meets the above criteria. For this reason, this embodiment of the closure means 26 is preferred, and the disclosures of these patents are incorporated herein by reference.
  • the closure means 26 is made of a meltable material which absorbs radiant, or electromagnetic, energy, such as radio waves, infrared waves, visible light, ultraviolet waves, x-rays, and the like.
  • closure means 26 is purposely selected so that it melts only in response to temperatures sufficient to rapidly destroy any bacterial conntaminant on the surface of the material.
  • the walls 15 of the body 12 are preferably made of a material which, relative to the absorption characteristics of the closure means material, is generally nonabsorbant of, and thus generally transparent to, the radiant energy used to melt the closure means 26.
  • the walls 15 are not themselves heated to any great extent. Rather, the walls 15 serve to pass the radiant energy directly to the closure means 26. The transfer of radiant heat to the closure means 26 thus remains fast and efficient.
  • the axis of the ports 20 on one of the walls 15 are preferably laterally spaced from each of the axis of the ports 20 disposed in the opposite wall 15.
  • the device 10 preferably forms a component part of a fluid transfer assembly 28 shown in Fig. 1.
  • the attachment means 22 includes connector means 30 which is attachable to the end portion of the fluid conduit 24.
  • the connector means 30 is operative for secure engagement within the attachment means 22 of the device 10. A positive connection between the device 10 and the conduit 24 is thus assured.
  • the connector means 30 also includes, like the ports 20 associated with the device 10, closure means 32 for normally sealing each connector means 30, and thus the fluid conduit 24 itself, from communication with the atmosphere.
  • each connector means 30 is also selectively removable to open the conduit 24 to fluid flow.
  • the closure means 32 is removable in the identical manner as the closure means 26 associated with the ports 20.
  • the connector means 30 may be variously constructed. However, in the illustrated embodiment (see, in particular, Figs. 2 through 4), each connector means 30 includes a tubular housing 36 which defines a hollow interior 38.
  • the closure means 32 preferably takes the form of a meltable, radiant energy absorbing wall which normally seals or closes the interior 38 from communication with the atmosphere.
  • Each housing 36 further includes a tubular passage portion 40 (see Fig. 1) which communicates with the interior 38 and which serves to interconnect the housing 36 with its associated length of fluid conduit 24. While the housing 36 may be variously attached to the end of the conduit 24, in the illustrated embodiment, a hermetic, friction fit with the tubular passage portion 40 is envisioned. As is shown in Fig. 1, an elastic band 42, such as one made from a latex material, preferably encircles the outer periphery of the junction to assure a fluid-tight, hermetic fit between the passage portion 40 and the respective conduit 24.
  • an inline valve member 44 is provided to normally prevent fluid flow communication with the interior 38 of the housing 36. While the valve member 44 may be variously constructed, in the illustrated embodiment, it takes the form of a inline frangible valve member such as the valve member disclosed in Carter et al, U.S. Patent No. 4,294,247.
  • the frangible valve member 44 can form an integral part of the connector housing 36, as is generally shown in Granzow et al, U.S. Patent No. 4,265,280.
  • the housing 36 is preferably made of material which does not absorb, and is thus transparent to, the particular type of
  • the closure means 26 and 32 are both made of a material fabricated from poly(4-methyl-l-pentene) which is sold under the trademark TPX by Mitsui Chemical • ⁇ ⁇ Company. This material has a crystalline melting point of approximately 235°C and is further discussed in Boggs et al, U.S. Patent No. 4,325,417.
  • the material of the closure means 26 and 32 includes a carbon filler so as to absorb virtually any type of 0 radiant energy which lies in a continuous band encompassing infrared, visible, and ultraviolet radiation.
  • the walls 15 of the device 10 and the housing 36 of the connector means 30 are each made of a clear TPX material which is generally transparent 5 to the passage of radiant energy lying in this band.
  • the attachment means 22 of the device 10 also includes a diametrically spaced pair of upstanding shoulders 46 peripherally surrounding 0 each port 20. As shown in Fig. 2, the shoulders 46
  • Cl',71 are resiliently deformable axially outwardly of the axis of the associated port 20.
  • a locking groove 48 (see Figs. 2 through 4) is formed circumferentially about the interior of each of the shoulders 46.
  • the housing 36 of each of the connector means 30 includes a locking ridge 50.
  • the ridge 50 resiliently deforms the shoulders -46 axially outwardly.
  • the ridge 50 locks into a secure snap-fit engagement with the groove 48 at the time the closure means 26 and 32 are in facing contact.
  • the attachment means 22 could take the form of a twist lock, screw, or other snap-fit arrangement which securely interlocks the connector means 38 and the device 10 with the closure means 26 and 32 in facing contact.
  • the radiant energy source 18 which, in the illustrated embodiment, consists of incandescent quartz lamp having a tungsten filament operating at about 3150" K.
  • the lamp is focused on the radiant energy-absorbing closure means 26 and 32.
  • the closure means 26 and 32 melt and fuse together, as can be seen in Fig. 4.
  • closure means 26 and 32 form the hermetically sealed fluid path 34 which is at once sterile and closed to communication with the atmosphere.
  • one of the closure means 26 or 32 could be made of a meltable transparent material which would melt by conductive heat transfer as the other opaque closure means 26 or 32 melts in response to radiant heat.
  • Bacillus subtilis var niger globiguii
  • Bacillus subtilis var niger globiguii
  • This organism was chosen because of its high resistance to dry heat (see Angelotti, et al, "Influence of Spore Moisture Content on the Dry Heat Resistance of Bacillus subtilis var niger", Appl. Microbiol. , v 16 (5): 735-745, 1968).
  • Test Connectors were coupled together, forming forty (40) connections between the empty containers and the SCD broth containers.
  • the noninoculated Negative Control Connectors were also coupled together, forming eight (8) connections between the empty containers and the SCD broth containers. Each connection was exposed to the quartz lamp radiant energy source as heretofore described to fuse the walls together and open a fluid path. The medium was then passed through the connections.
  • a sterile fluid transfer system 54 is shown which is suited for use in the compounding of hyperalimentation solutions and the like. To assure sterility during compounding, the system 54 includes a multiple access fluid transfer assembly 28 as heretofore described.
  • the system 54 also includes one or more sources 56 of fluid.
  • the sources 56 In hyperalimentation therapy, one of the sources 56 would contain a protein; one would contain a carbohydrate; one would contain a vitamin, etc.
  • Each fluid source 56 includes an integrally attached fluid conduit 58 which conducts fluid from the source 56.
  • One connector means 30 is attached at the end of each fluid conduit 58.
  • the system 54 also includes one or more fluid receiving receptacles 60. The hyperalimentation solution will be compounded, or mixed, in this receptacle 60.
  • Each receptacle 60 includes an integrally attached fluid conduit 62 which serves to conduct fluid into the receptacle 60.
  • One connector means 30 is attached to the end of the conduit 62.
  • the protein, carbohydrate, and vitamin fluids contained in the sources 56 can be compounded, or mixed, in one or more of the fluid receiving receptacles 60. As already explained, this compounding can occur in a manner which does not breach the sterile integrity of the sources 56, the receptacles 60, or of any of the formed solutions.
  • the connector means 30 associated with the fluid sources 56 of the fluid ingredients can be attached to the ports 20 on one of the walls 15 of the device 10.
  • the connector means 30 associated with one or more of the fluid receiving receptacles 60 can be attached to a port 20 on the oppositely facing wall 15.
  • the fluid ingredients can be transferred by gravity from the attached sources 56. into the attached fluid receptacles 60.
  • inline roller clamps 64 or the like can be operatively connected with each conduit 58 and 62 to meter the transfer of fluids.
  • the devices 10 may be manufactured and packaged in a unit 11 comprising a plurality of the devices 10.
  • the devices 10 may be joined together with a frangible connection 55 along adjacent walls 15.
  • Each device 10 can be broken away from the unit 11 at the time of use.
  • FIG. 6 An alternate embodiment of a fluid mixing system 55 which utilizes the fluid transfer assembly 28 is shown in Fig. 6.
  • the conduit 58 which is integrally attached with the fluid receiving receptacle 60 is itself integrally attached to one port 20 of the fluid transfer device 10.
  • the transfer of fluids from the sources 56 into the receiving receptacle can progress as heretofore described, except that, in this embodiment, there is no need to form a connection between the fluid receiving receptacle 60 and the device 10.
  • the device 10 can be integrally attached (as in Fig. 6) to a length of tubing communicating with the peritoneal cavity of a patient on peritoneal dialysis.
  • the connector means 30 would be carried at the end of a conduit which communicates with a dialysate container.
  • the multiple connections required during the course of peritoneal dialysis can be sequentially accommodated via the device 10 to introduce and drain the dialysate.

Abstract

Un assemblage de transfert de fluide comprend un dispositif de transfert de fluide à accès multiples (10) possédant une série d'orifices d'accès (20), ainsi que deux ou plusieurs organes connecteurs (30) chacun desquels peut être raccordé à une conduite de fluide (24). Chaque orifice d'accès (20) et chaque organe connecteur (30) est normalement isolé de l'atmosphère au moyen d'une fermeture étanche (26), (32) qui peut être enlevée uniquement en combinaison avec une étape active de stérilisation. L'organe connecteur (30) peut être raccordé à l'un quelconque des orifices d'accès (20), les fermetures respectives (26 et 32) étant en contact en vis à vis. Pendant l'étape active de stérilisation, les fermetures sont enlevées pour former un chemin de fluide hermétique stérile. Grâce aux multiples raccordements stériles que l'on peut établir, l'assemblage ci-décrit est tout à fait indiqué pour une utilisation dans des systèmes de fluide associés à des procédures médicales, telles que la thérapie d'hyperalimentation et la dialyse péritonéale.
EP83902378A 1982-07-09 1983-06-09 Systeme sterile de transfert de fluide et dispositif associe de transfert de fluide a acces multiples Withdrawn EP0113758A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US39656082A 1982-07-09 1982-07-09
US396560 1982-07-09

Publications (1)

Publication Number Publication Date
EP0113758A1 true EP0113758A1 (fr) 1984-07-25

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EP (1) EP0113758A1 (fr)
WO (1) WO1984000340A1 (fr)

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DE3520044A1 (de) * 1985-06-04 1986-12-04 Baxter Travenol Laboratories, Inc., Deerfield, Ill. Anordnung zur verabreichung und/oder herstellung von medikament- und/oder naehrloesungen, insbesondere parenteralen naehrloesungen
US4915688A (en) * 1987-12-03 1990-04-10 Baxter International Inc. Apparatus for administering solution to a patient
US7175336B2 (en) * 2001-01-26 2007-02-13 Depuy Acromed, Inc. Graft delivery system
EP2377570B1 (fr) 2010-04-13 2013-09-11 Gambro Lundia AB Connecteur pour ligne de transport de fluide d'un dispositif médical
EP3524288A3 (fr) 2011-03-23 2019-11-20 NxStage Medical Inc. Systèmes de dialyse péritonéale
US9861733B2 (en) 2012-03-23 2018-01-09 Nxstage Medical Inc. Peritoneal dialysis systems, devices, and methods
US11872337B2 (en) 2018-02-28 2024-01-16 Nxstage Medical, Inc. Fluid preparation and treatment devices methods and systems

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US4265280A (en) * 1979-01-23 1981-05-05 Baxter Travenol Laboratories, Inc. Connector member for sealed conduits
US4325417A (en) * 1979-04-06 1982-04-20 Baxter Travenol Laboratories, Inc. Connector member for sealed conduits utilizing crystalline plastic barrier membrane
US4298001A (en) * 1980-08-08 1981-11-03 Hargest Iii Thomas S Fluid flow connector unit and method

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