EP0495330A1 - Access device for flexible containers - Google Patents

Access device for flexible containers Download PDF

Info

Publication number
EP0495330A1
EP0495330A1 EP91500092A EP91500092A EP0495330A1 EP 0495330 A1 EP0495330 A1 EP 0495330A1 EP 91500092 A EP91500092 A EP 91500092A EP 91500092 A EP91500092 A EP 91500092A EP 0495330 A1 EP0495330 A1 EP 0495330A1
Authority
EP
European Patent Office
Prior art keywords
addition
extraction
elastomeric
needle
piece
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Withdrawn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
EP91500092A
Other languages
German (de)
English (en)
French (fr)
Inventor
Francisco Faraco Munoz
Miguel Angel Moreno De La Guerra
Gregorio Frias Garcia
Carlos Manuel Sandoval Balcazar
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.)
INSTITUTO DE BIOLOGIA Y SUEROTERAPIA SA
Original Assignee
INSTITUTO DE BIOLOGIA Y SUEROTERAPIA SA
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 INSTITUTO DE BIOLOGIA Y SUEROTERAPIA SA filed Critical INSTITUTO DE BIOLOGIA Y SUEROTERAPIA SA
Publication of EP0495330A1 publication Critical patent/EP0495330A1/en
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports

Definitions

  • the present invention as expressed in the title of this Specification, comprises an external device attached to flexible containers, for the extraction and/or addition of liquids contained, or to be contained, in said containers; being sterilizable and of particular application for large-volume parenteral solutions.
  • the devices currently available are characterized in being formed with an elaborated edge, on manufacturing the flexible container, clamping therein an elastomeric member, included in a tubular piece of material such as polyethylene or polyvinylchloride, maintaining sterility with an adhesive cover, or with a strip of polyvinylchloride which is torn off at the time of use; they have the drawback of several materials being in contact with the contained solutions, the elastomer itself, the polyethylene or polyvinylchloride of the member containing the elastomer and the material which the flexible container is composed of, which can be polyvinylchloride, polyolefines, polyamides, etc., and their adhesives and further additives, which involves an extraction of products of those materials in a greater variety, undesired due to the problems they can promote on administering the solution; in other cases they are external systems attached to flexible multilayer containers, which layers are joined by adhesives which can migrate to the contained solution, likewise an undesired effect for administration of the contained
  • the object of the invention relies on achieving an outer device to the container, that would contain the necessary elastomers to serve as liquid retaining joint, around the punches of the administration equipments and needles for addition and/or extraction, avoiding leakages through dripping; which, as safety measure, serve to confirm that the container has not been tampered with; being attached to the outer surface of single- or multi-layer coextruded flexible containers, without the need for adhesives, manufactured from different types of materials but kept in contact with the polyolefines solution to reduce transfer; this attachment being carried out by physical means such as heat, ultrasound, or high frequency welding, without using adhesives, the arrangement of solution, container and access device being susceptible to sterilization at temperatures between 100 C and 130 C, with wet heat in equipments with vapor or superheated water.
  • the device has a flat and flexible zone (1), to attach the device to the outer part of the flexible container by heat, ultrasound or high frequency welding without the need to use adhesives, on the piece being manufactured with materials identical to those of the multilayer of the container: polyolefine homopolymers, polyolefine copolymers, natural and synthetic elastomers, polyamides and combinations, modifications or special arrangements thereof; in the lower side this zone has two openings (2) and (3) formed at the time of injection, thereby avoiding the particles that can be produced if carried out by piercing; such holes serve to allow entry or release of the liquid once the outside of the container has been pierced.
  • elastomeric pieces (6) and (7) which are inserted into the openings (2) and (3) before deforming the bulges (4) and (5);
  • one of the elastomeric pieces (6) serves for effecting the closure around the punch of the administration equipment and can be solid, in which case the punch should pierce it, or in O-ring shape with circular cross-section, in which case the ring engages the outside of the punch;
  • the other elastomeric piece (7) serves to carry out the closure around the addition or extraction needle, while piercing and self-sealing is being effected when the needle is withdrawn;
  • these pieces can be manufactured by moulds of different materials such as virgin gum, butyl chloride, butyl bromide, EPDM, silicone gum and other elastomers, as well as by the injection of thermoplastic elastomers; in all the cases they should be compatible with large-volume solutions and with sterilization at temperatures between 100 c and 130 C with wet heat.
  • the device narrows inside, to avoid said pieces (8 and 9) moving, in tube shape and suitable sizes, in the one case, to the punch of the administration equipment (8) and, in the other case, to that of the addition or extraction needle (9).
  • tubular shapes end in flat zones which serve as seal to guarantee the container has not been tampered with, which can be planes (10) and (11) parallel to the welding plane (1), in which case the opening is effected by piercing with the punch or with the needle, or planes (12) and (13) perpendicular to the welding plane (1) in suitable shape to hold such planes with the fingers, pincers and pliers or other similar instrument, and by twisting leaving exposed the tubular accesses to the elastomeric pieces, aided by respective perimetral recesses (14) and (15) which facilitate the tearing.
  • planes (10) and (11) parallel to the welding plane (1) in which case the opening is effected by piercing with the punch or with the needle, or planes (12) and (13) perpendicular to the welding plane (1) in suitable shape to hold such planes with the fingers, pincers and pliers or other similar instrument, and by twisting leaving exposed the tubular accesses to the elastomeric pieces, aided by respective perimetral rece
  • tubular piece (9) adapted to the addition or extraction needle may have injected shapes (16) of male screws of the luer type, luer-lock, record or any other suitable screw or figure for attaching accessories, that allow facilitating the addition or extraction of liquids or solutions, once the security seal (11) or (13) is removed.
  • the device may comprise a flat zone (17) perpendicular to the welding plane (1) joining the two tubular access shapes (8) and (9).
  • Figure 1 represents the plant and an elevational section of a device in which the bulges (4) and (5) appear undeformed in the left-hand part of the elastomeric pieces (6) and (7) and deformed in the right-hand side; it is characterized by having both solid elastomeric pieces and the flat zones (10) and (11) of the security seal parallel to the welding plane (1), and the length of the tubular shape (9) suitable for all kinds of needles.
  • Figure 2 represents an elevational section of a device in which the bulges (4) and (5) appear undeformed in the left-hand part of the elastomeric pieces (6) and (7) and deformed in the right-hand part; it is characterized by having both solid elastomeric pieces, the flat zones (12) and (13) of the security seal perpendicular to the welding plane (1) and the length of the tubular shape (9) suitable for all kinds of needles.
  • Figure 3 represents an elevational section of a device in which the bulges (4) and (5) appear undeformed in the left-hand part of the elastomeric pieces (6) and (7) and deformed in the right-hand side; it is characterized by having the elastomeric piece (6) for the closure at the punch of the administration equipment in O-ring shape and the solid elastomeric piece (7), the flat zones (12) and (13) of the security seal perpendicular to the welding plane (1) and the length of the tubular shape (9) suitable for long needles.
  • Figure 4 represents an elevational section of a device in which the bulges (4) and (5) appear as injected, i.e., undeformed; the elastomeric pieces (6) and (7) are the same as in Figure 3, one being solid and the other one being an O-ring, the flat zones (12) and (13) of the security seal perpendicular to the welding plane (1), the length of the tubular shape (9) suitable for long needles and the length of the tubular shape (8) suitable for short punches.
  • Figure 5 represents an elevational section of a device of similar characteristics to that of figure 4, with the difference that the lengths of the tubular shapes (8) and (9) are suitable for every kind of punch and needle.
  • Figure 6 represents the plant and an elevational section of a device with characteristics similar to those of Figure 5, in which a male screw (16) has been represented to allow attaching the accessories for addition or extraction, once the security seal (13) is removed.
  • Figure 7 represents top views and side sections of the elastomeric pieces (6) and (7).
  • Figure 8 represents a side view of a device according to the invention, attached to a flexible container (18).

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP91500092A 1991-01-17 1991-08-08 Access device for flexible containers Withdrawn EP0495330A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES9100145U ES1016714Y (es) 1991-01-17 1991-01-17 Dispositivo de acceso para recipientes flexibles.
ES9100145U 1991-01-17

Publications (1)

Publication Number Publication Date
EP0495330A1 true EP0495330A1 (en) 1992-07-22

Family

ID=8270860

Family Applications (1)

Application Number Title Priority Date Filing Date
EP91500092A Withdrawn EP0495330A1 (en) 1991-01-17 1991-08-08 Access device for flexible containers

Country Status (3)

Country Link
EP (1) EP0495330A1 (fi)
ES (1) ES1016714Y (fi)
FI (1) FI912922A (fi)

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5351383A (en) 1992-07-29 1994-10-04 Minnesota Mining And Manufacturing Company Method of making an injection or sampling site
US5658260A (en) 1988-01-25 1997-08-19 Baxter International Inc. Bayonet lock cannula for pre-slit y-site
US5776125A (en) 1991-07-30 1998-07-07 Baxter International Inc. Needleless vial access device
US5797897A (en) 1988-01-25 1998-08-25 Baxter International Inc. Pre-slit injection site and tapered cannula
DE19728775A1 (de) * 1997-07-05 1999-01-21 Fresenius Ag Originalitätsverschluß für medizinische Flüssigkeiten enthaltende Verpackungen
DE19808295A1 (de) * 1998-02-27 1999-11-11 Boehringer Ingelheim Int Behälter für eine medizinische Flüssigkeit
US6193697B1 (en) 1987-03-17 2001-02-27 Baxter International Inc. Pre-slit injection site and tapered cannula
US6217568B1 (en) 1988-01-25 2001-04-17 Edwards Lifesciences Corporation Preslit injection site and tapered cannula for blood sampling
US6685691B1 (en) 1998-02-27 2004-02-03 Boehringer Ingelheim Gmbh Container for a medicinal liquid
US6988496B1 (en) 1999-02-23 2006-01-24 Boehringer Ingelheim International Gmbh Cartridge for a liquid
WO2006042579A1 (de) * 2004-10-20 2006-04-27 Fresenius Kabi Deutschland Gmbh Verschlusskappe für mit medizinischen flüssigkeiten befüllte behältnisse
US7090093B2 (en) 1998-11-07 2006-08-15 Boehringer Ingelheim International Gmbh Pressure compensation device for a two-part container
US7793655B2 (en) 1996-04-19 2010-09-14 Boehringer Ingelheim Pharma Gmbh & Co. Kg Two-chamber cartridge for propellant-free metering aerosols
US7963955B2 (en) 1998-02-27 2011-06-21 Boehringer Ingelheim International Gmbh Container for a medicinal liquid
USD860675S1 (en) 2016-12-29 2019-09-24 Conopco, Inc. Cartridge
USD862924S1 (en) 2016-12-29 2019-10-15 Conopco, Inc. Dispenser

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2160184A (en) * 1984-06-15 1985-12-18 Rexam Medical Packaging Limited Sterile liquid dispensing bags
GB2203118A (en) * 1987-04-07 1988-10-12 Fuso Pharmaceutical Ind Plastics transfusion containers
WO1989006553A2 (en) * 1988-01-25 1989-07-27 Baxter International Inc. Pre-slit injection site and tapered cannula
US4892222A (en) * 1988-11-25 1990-01-09 Baxter International Inc. Port assembly for a container
DE8910550U1 (de) * 1989-09-04 1991-01-10 Pfrimmer Kabi GmbH & Co KG, 8520 Erlangen Beutel zur Aufnahme von in den menschlichen Körper zu überführender Flüssigkeit

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2160184A (en) * 1984-06-15 1985-12-18 Rexam Medical Packaging Limited Sterile liquid dispensing bags
GB2203118A (en) * 1987-04-07 1988-10-12 Fuso Pharmaceutical Ind Plastics transfusion containers
WO1989006553A2 (en) * 1988-01-25 1989-07-27 Baxter International Inc. Pre-slit injection site and tapered cannula
US4892222A (en) * 1988-11-25 1990-01-09 Baxter International Inc. Port assembly for a container
DE8910550U1 (de) * 1989-09-04 1991-01-10 Pfrimmer Kabi GmbH & Co KG, 8520 Erlangen Beutel zur Aufnahme von in den menschlichen Körper zu überführender Flüssigkeit

Cited By (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6193697B1 (en) 1987-03-17 2001-02-27 Baxter International Inc. Pre-slit injection site and tapered cannula
US5797897A (en) 1988-01-25 1998-08-25 Baxter International Inc. Pre-slit injection site and tapered cannula
US6605076B1 (en) 1988-01-25 2003-08-12 Baxter International Inc. Pre-slit injection site and tapered cannula
US5871500A (en) 1988-01-25 1999-02-16 Baxter International Inc. Pre-slit injection site and tapered cannula
US5658260A (en) 1988-01-25 1997-08-19 Baxter International Inc. Bayonet lock cannula for pre-slit y-site
US6217568B1 (en) 1988-01-25 2001-04-17 Edwards Lifesciences Corporation Preslit injection site and tapered cannula for blood sampling
US6261266B1 (en) 1988-01-25 2001-07-17 Baxter International Inc. Pre-slit injection site and tapered cannula
US6447498B1 (en) 1988-01-25 2002-09-10 Baxter International Inc. Pre-slit injection site and tapered cannula
US6569125B2 (en) 1988-01-25 2003-05-27 Baxter International Inc Pre-slit injection site and tapered cannula
US5776125A (en) 1991-07-30 1998-07-07 Baxter International Inc. Needleless vial access device
US5400500A (en) 1992-07-29 1995-03-28 Minnesota Mining And Manufacturing Company Apparatus for making an injection or sampling site
US5351383A (en) 1992-07-29 1994-10-04 Minnesota Mining And Manufacturing Company Method of making an injection or sampling site
US7793655B2 (en) 1996-04-19 2010-09-14 Boehringer Ingelheim Pharma Gmbh & Co. Kg Two-chamber cartridge for propellant-free metering aerosols
US7980243B2 (en) 1996-04-19 2011-07-19 Boehringer Ingelheim Pharma Gmbh & Co., Kg Two-chamber cartridge for propellant-free metering aerosols
DE19728775A1 (de) * 1997-07-05 1999-01-21 Fresenius Ag Originalitätsverschluß für medizinische Flüssigkeiten enthaltende Verpackungen
DE19728775C2 (de) * 1997-07-05 2002-01-31 Fresenius Ag Originalitätsverschluß für medizinische Flüssigkeiten enthaltende Verpackungen
DE19808295A1 (de) * 1998-02-27 1999-11-11 Boehringer Ingelheim Int Behälter für eine medizinische Flüssigkeit
US7963955B2 (en) 1998-02-27 2011-06-21 Boehringer Ingelheim International Gmbh Container for a medicinal liquid
US6685691B1 (en) 1998-02-27 2004-02-03 Boehringer Ingelheim Gmbh Container for a medicinal liquid
US7090093B2 (en) 1998-11-07 2006-08-15 Boehringer Ingelheim International Gmbh Pressure compensation device for a two-part container
US6988496B1 (en) 1999-02-23 2006-01-24 Boehringer Ingelheim International Gmbh Cartridge for a liquid
US7802568B2 (en) 1999-02-23 2010-09-28 Boehringer Ingelheim International Gmbh Cartridge for a liquid
WO2006042579A1 (de) * 2004-10-20 2006-04-27 Fresenius Kabi Deutschland Gmbh Verschlusskappe für mit medizinischen flüssigkeiten befüllte behältnisse
EA009498B1 (ru) * 2004-10-20 2008-02-28 Фрезениус Каби Дойчланд Гмбх Колпачок для заполненных медицинскими жидкостями емкостей
AU2005297511B2 (en) * 2004-10-20 2012-02-02 Fresenius Kabi Deutschland Gmbh Closing cap for containers filled with medical liquids
US8211081B2 (en) 2004-10-20 2012-07-03 Fresenius Kabi Deutschland Gmbh Closing cap for containers filled with medical liquids
USD860675S1 (en) 2016-12-29 2019-09-24 Conopco, Inc. Cartridge
USD862924S1 (en) 2016-12-29 2019-10-15 Conopco, Inc. Dispenser

Also Published As

Publication number Publication date
FI912922A0 (fi) 1991-06-17
FI912922A (fi) 1992-07-18
ES1016714U (es) 1991-12-01
ES1016714Y (es) 1992-07-01

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