EP1096914B1 - Connecteur sterile pour recipients contenant des liquides a usage medical - Google Patents

Connecteur sterile pour recipients contenant des liquides a usage medical Download PDF

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Publication number
EP1096914B1
EP1096914B1 EP99932848A EP99932848A EP1096914B1 EP 1096914 B1 EP1096914 B1 EP 1096914B1 EP 99932848 A EP99932848 A EP 99932848A EP 99932848 A EP99932848 A EP 99932848A EP 1096914 B1 EP1096914 B1 EP 1096914B1
Authority
EP
European Patent Office
Prior art keywords
barrier module
base
connector
connector according
barrier
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.)
Expired - Lifetime
Application number
EP99932848A
Other languages
German (de)
English (en)
Other versions
EP1096914A1 (fr
Inventor
Bernd Knierbein
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.)
Fresenius SE and Co KGaA
Original Assignee
Fresenius SE and Co KGaA
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 Fresenius SE and Co KGaA filed Critical Fresenius SE and Co KGaA
Publication of EP1096914A1 publication Critical patent/EP1096914A1/fr
Application granted granted Critical
Publication of EP1096914B1 publication Critical patent/EP1096914B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61J1/05—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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52—Details
    • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/5861—Spouts
    • B65D75/5872—Non-integral spouts
    • B65D75/5883—Non-integral spouts connected to the package at the sealed junction of two package walls
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2575/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D2575/52—Details
    • B65D2575/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D2575/583—Opening or contents-removing devices added or incorporated during package manufacture the non-integral spout having an elongate cross-sectional shape, e.g. canoe or boat shaped

Definitions

  • the invention relates to a sterile connector for medical liquids, especially containers containing liquids for enteral nutrition.
  • Known plastic containers for holding enteral nutrient solutions consist of Composite films that are sufficiently diffusion-tight.
  • the disadvantage is that the generally consisting of polyolefins, especially polypropylene Connector (port) of the known foil bag is permeable to certain gases. There is therefore a risk of undesirable reactions of the contents Oxygen. Flavorings contained in the contents can also be passed through the connector diffuse.
  • the storage of enteral nutrient solutions a decrease in vitamin C levels over time. To that extent the storage time is limited.
  • DE 297 06 159 proposes on the underside of the container facing the container Connector a barrier module in the form of a flexible plastic film from one Attach material with sufficient diffusion tightness.
  • the barrier module creates a barrier between the contents of the container and the connector, which Prevents or at least significantly limits the passage of gases.
  • Foil bag is the one intended for welding the lower part of the connector Piece of film a well-known composite film based on a gas-tight metallic foil material with a coating of a Plastic material that can be welded to the connector.
  • the disadvantage is that these films are not sorted. They are also sealed with EVOH foils Connectors known.
  • EVOH as a barrier material disadvantageous in that the exposed cut edges of the film piece very much are sensitive, since the piece of film consists of a cut into strips Foil sheet is punched. So it has been shown that on the open cut edges increased discoloration and delamination after exposure to temperature and humidity as in sterilization. They are also direct Interactions between the internal film components and the Product cannot be excluded.
  • barrier modules in the form of flexible pieces of film is that positive and non-positive connections are not possible. In this respect, the connection technology is limited.
  • the welding of the piece of film to the connector is relative consuming.
  • the effort corresponds approximately to that of welding the connector in the foil pouch. Leaks can also occur at the weld seam.
  • the invention has for its object to provide a sterile connector which guarantees high gas tightness, is easy to handle and large Lots can be produced inexpensively.
  • the barrier module is an injection molded part with a core and an envelope.
  • the core consists of one for certain Gases are essentially impermeable material while wrapping out a material corresponding to the base body, so that base body and Injection molded part can be welded together.
  • the sterile connector is sealed in a foil pouch, the Pouch film with both the base body, the one with the film weldable material exists, as well as welded to the barrier module become; which is made of the same material as the base body. This is it is possible to seal the container closure almost completely for gases.
  • the barrier module can be used as an injection molded part in large quantities can be manufactured inexpensively with low tolerances.
  • the known injection molding machines which have two plasticizing units, be used. With the injection molding machine first the wrapping and then the core is injected into a tool cavity. This procedure will also referred to as sandwich or co-injection.
  • the sandwich structure of the injection molded in one piece Barrier module is relatively insensitive. Open cut edges that are made with foils EVOH due to high temperatures and high humidity, as with Sterilize, lead to delamination and discoloration. are with the Barrier module not available.
  • the barrier module is attached to the Base body welded on.
  • barrier module and Base body connected by force and / or positive engagement. So can the barrier module on the base body, for example with a snap or Clamp connection to be attached.
  • Base body and barrier module can, for example, by Film hinges are held together so that these parts after Injection molding can be folded and firmly connected.
  • the barrier module preferably forms a pierceable membrane Closure of the passage in the connector by means of a piercing dome can be pierced.
  • the barrier module is one of the sub and / or Plate covering the top of the base body.
  • the barrier module is on the Base body between one closing the passage and one the passage releasing position slidably attached. This forms the barrier module as it were a closure part which is actuated by the connecting pin 33.
  • the barrier module preferably has an oxygen barrier less than 1 cm 3 / m 2 d bar.
  • the material from which the essentially diffusion-tight core of the barrier module is made is preferably EVOH (ethylene-vinyl alcohol copolymer) or PA (polyamide).
  • the covering of the barrier module is preferably made of polypropylene, so that the known bag films, which have a sealing layer on the inside made of the same material, can be easily welded to the barrier module.
  • the welded parts have a higher melting point than the sterilization temperature and can therefore be sterilized in an autoclave.
  • the connector according to the invention can be used in medical packaging units different training can be used.
  • a preferred one Areas of application are with a medical fluid, especially one Fluid for enteral nutrition, filled foil bags.
  • the connector 1 manufactured as an injection molded part from polypropylene comprises one Base body 2 with a lower part 3 and formed in the manner of a boat a tubular upper part 4 and a protective cap 5: the lower part 3 has a tubular section 6 with two radially projecting wing-like Approaches 7, 8 is provided, which lie in one plane.
  • the lower part 3 is with the Inside of the bag film of the known film bags for medical Liquids welded.
  • the tubular upper part 4, which connects to the lower part 3, is with a External thread 9 provided for screwing on a union nut.
  • the upper part 4 On his upper edge, the upper part 4 has an inwardly projecting projection 10, the in a receptacle 11 for the rotationally secure reception of a piercing mandrel transforms.
  • the protective cap 5 closing the upper part 4 of the connector 1 is provided in the area of its lower edge with a ring break zone 12 and with the approach 11 of the upper part 4 connected.
  • the trained as a break-off part Protective cap 5 is provided with two radially projecting wings 13, 14. To the Opening the connector, the protective cap 5 is rotated about its longitudinal axis, so that the wall breaks at the annular weakening zone 12.
  • the barrier module 15 is a plate-shaped injection molding, which is a sandwich structure in one piece is injection molded. It covers the entire underside of the base body and is included welded to the base body.
  • FIG. 3 shows the sandwich structure of the barrier module.
  • the injection molded part has a core 15a made of a material which is essentially impermeable to certain gases.
  • the core consists of a gas-tight plastic such as EVOH (ethylene vinyl alcohol copolymer) and forms an oxygen barrier of less than 20 cm 3 / m 2 d bar, preferably less than 1 cm 3 / m 2 d bar.
  • the core 15a is enclosed by a covering 15b made of the same material as the base body 2. Since the sheath 15b, like the base body 2, is made of polypropylene, the barrier module and base body can be welded together. It is also possible to weld the bag film to the edge of the barrier module 15.
  • the barrier module 15 is also on the upper side facing the base body provided a ring break zone 16, the diameter of that of the passage in corresponds to the base body, so that the barrier module when inserting the Spike can be pierced.
  • FIG. 4 shows the connector arrangement consisting of the connector 1 and the Spike 17 with union nut 18.
  • the tubular spike 17 has a tip 17a at one end and can with its other end with a plastic hose not shown in the figures Hose line system are connected, which in the upper approach 17b of the Spike is inserted.
  • the spike seals against that inner receptacle 11 of the connector top 4. Is against losing the union nut through a circumferential web 20 on the hose side End piece of the piercing mandrel secured.
  • FIGS 5a to c show different connection techniques Attachment of the barrier module 15 to the base body 2 of the connector.
  • Figure 5a shows a snap connection.
  • the lower part 3 has on its underside of the base body on a peripheral edge 22 which is undercut.
  • the Barrier module 15 is dimensioned such that it fits into the recess 23 of the Base body can be used and the undercut 24th is snapped in place.
  • FIG. 5b shows a clamp connection of the barrier module 15.
  • the barrier module has on its upper side a plurality of conical pins 25 which are circumferential are distributed. Are on the underside of the lower part 3 of the base body corresponding recesses 26 are provided, in which the pins of the Have the barrier module pressed in.
  • Figure 5c shows an embodiment in which the barrier module together with the base body of the connector is made as an injection molded part.
  • barrier module 15 and base body 2 are connected to one another by a film hinge 15c. After the injection molding, the barrier module is placed on the underside of the Base body folded and these two parts are welded together.
  • FIG. 6 shows a partial view of a further embodiment of the connector.
  • This embodiment differs from that with reference to FIG Figures 1 to 4 described embodiments in that the Barrier module 27 not on the underside of the lower part 3 of the base body 2, but is attached to the top.
  • the barrier module 27 is together with the upper part 4 of the connector as an injection molded part.
  • the top of the base body are along with the barrier module welded to the lower part of the base body.
  • this consists of the core and the casing existing barrier module 29 formed as a closure body.
  • the barrier module has a peripheral edge 30 or circumferentially distributed on its top arranged guide pins on, on the underside of the lower part 3 of the Base body 2 of the connector an annular recess 31 or corresponding recesses are provided into which the peripheral edge 30 or engage the guide pins of the barrier module 29 with slight clamping, so that the barrier module for opening the passage from the base body pushed away or to close the passage to the base body can be pushed up.
  • To seal the barrier module 29 against the lower part 3 of the base body is one outside the peripheral edge 30 lying ring seal 32 is provided on the top thereof.
  • the closure is actuated by means of a connecting pin 33 which instead of the piercing mandrel of the above embodiments in the channel-shaped Recess of the connector is introduced.
  • the connecting mandrel 33 instructs its lower end a revolving neck 34, while in the Barrier module 29 has a cylindrical recess 35 with an inward projecting projection 36 is provided on the upper edge in which the lower End of the connecting mandrel 33 can be snapped.
  • the connecting pin 33 is advanced or pushed back, whereby the barrier module designed as a closure body 29 is operated.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Packages (AREA)
  • Closures For Containers (AREA)

Claims (10)

  1. Connecteur stérile pour récipients contenant des liquides à usage médical, composé d'un élément de base (2), lequel présente une partie inférieure (3) insérable dans la paroi du récipient et étanche par rapport à cette dernière et une partie supérieure (4) dotée d'un passage pour le liquide, un module barrière (15), constitué d'un matériau essentiellement imperméable à certains gaz et recouvrant au moins partiellement la face supérieure de la partie inférieure (3) opposée au récipient et/ou la face inférieure de la partie inférieure (3) tournée ver le récipient, est prévu sur l'élément de base, caractérisé en ce que le module barrière (15) est une pièce moulée par injection possédant un noyau (15a) d'un matériau essentiellement imperméable à certains gaz et une enveloppe (15b) d'un matériau identique à celui de l'élément de base.
  2. Connecteur selon la revendication 1, caractérisé en ce que le module barrière (15) est soudé sur l'élément de base (2).
  3. Connecteur selon la revendication 1, caractérisé en ce que le module barrière (15) et l'élément de base (2) sont assemblés sous l'influence d'une force ou de façon mécanique.
  4. Connecteur selon l'une des revendications 1 à 3, caractérisé en ce qu la partie supérieure (4) de l'élément de base (2) est conçue pour accueillir un perforateur (17) et le module barrière (15) forme une seule et même pièce avec une membrane perforable, laquelle obture le passage dans l'élément de base.
  5. Connecteur selon la revendication 4, caractérisé en ce que le module barrière (15) est doté d'une zone d'amorce (16) au niveau du passage.
  6. Connecteur selon l'une des revendications 1 à 5, caractérisé en ce que le module barrière (15) est une plaque recouvrant la face inférieure et/ou supérieure de l'élément de base (2).
  7. Connecteur selon l'une des revendications 1 à 6, caractérisé en ce que le module barrière (29) est fixé sur l'élément de base (2) de façon déplaçable entre les positions de fermeture et d'ouverture du passage.
  8. Connecteur selon l'une des revendications 1 à 7, caractérisé en ce que le noyau (15a) du module barrière (15) est composé d'un matériau dont la barrière à l'oxygène est inférieure à 20, de préférence à 1 cm3/m2 d bar.
  9. Connecteur selon la revendication 8, caractérisé en ce que le noyau (15a) du module barrière (15) est composé d'un matériau à base d'EVOH.
  10. Connecteur selon l'une des revendications 1 à 9, caractérisé en ce que l'enveloppe (15b) du module barrière (15) est composée d'un matériau à base de polyoléfine, de préférence à base de polypropylène.
EP99932848A 1998-07-11 1999-07-07 Connecteur sterile pour recipients contenant des liquides a usage medical Expired - Lifetime EP1096914B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19831235 1998-07-11
DE19831235A DE19831235C1 (de) 1998-07-11 1998-07-11 Steriler Konnektor für medizinische Flüssigkeiten enthaltende Behälter
PCT/EP1999/004776 WO2000002517A1 (fr) 1998-07-11 1999-07-07 Connecteur sterile pour recipients contenant des liquides a usage medical

Publications (2)

Publication Number Publication Date
EP1096914A1 EP1096914A1 (fr) 2001-05-09
EP1096914B1 true EP1096914B1 (fr) 2002-10-09

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP99932848A Expired - Lifetime EP1096914B1 (fr) 1998-07-11 1999-07-07 Connecteur sterile pour recipients contenant des liquides a usage medical

Country Status (12)

Country Link
US (1) US6364143B1 (fr)
EP (1) EP1096914B1 (fr)
JP (1) JP2002520093A (fr)
KR (1) KR100602485B1 (fr)
CN (1) CN1303258A (fr)
AR (1) AR019897A1 (fr)
AT (1) ATE225639T1 (fr)
BR (1) BR9912022A (fr)
DE (2) DE19831235C1 (fr)
ES (1) ES2185370T3 (fr)
HK (1) HK1035315A1 (fr)
WO (1) WO2000002517A1 (fr)

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WO2004009158A2 (fr) 2002-07-19 2004-01-29 Baxter International Inc. Systemes et methodes de dialyse peritoneale
US7350669B2 (en) 2002-10-11 2008-04-01 Novartis Ag Closure device for flexible pouches
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DE10348016B4 (de) * 2003-10-15 2007-05-03 Fresenius Kabi Deutschland Gmbh Konnektor für medizinische Flüssigkeiten enthaltende Verpackungen und Verpackung für medizinische Flüssigkeiten
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US7736328B2 (en) 2007-07-05 2010-06-15 Baxter International Inc. Dialysis system having supply container autoconnection
US8057679B2 (en) 2008-07-09 2011-11-15 Baxter International Inc. Dialysis system having trending and alert generation
EP2332610B1 (fr) * 2009-12-10 2013-02-13 Fresenius Kabi Deutschland GmbH Système de raccordement pour récipients d'aliments destinés à la nutrition entérale
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US20160242998A1 (en) * 2013-09-25 2016-08-25 Fresenius Kabi Deutschland Gmbh Food arrangement
DE102014226702B4 (de) * 2014-12-19 2019-02-21 B. Braun Melsungen Ag Verbindungseinheit für ein medizinisches Fluidsystem
WO2016207206A1 (fr) 2015-06-25 2016-12-29 Gambro Lundia Ab Système et procédé de dispositif médical comprenant une base de données distribuée
CN108135775B (zh) * 2015-10-09 2021-10-29 费森尤斯卡比德国有限公司 用于容纳肠内营养液的容器的盖
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BR112019012719A2 (pt) 2016-12-21 2019-11-26 Gambro Lundia Ab sistema de dispositivo médico incluindo infraestrutura de tecnologia de informação tendo domínio de agrupamento seguro suportando domínio externo
WO2021131045A1 (fr) * 2019-12-27 2021-07-01 ウィーン医科大学 Tube de collecte de sang permettant la mesure de la viscosité du sang, dispositif de mesure de la viscosité du sang, et paquet étanche de tube de collecte de sang permettant la mesure de la viscosité du sang
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7703760B2 (en) 2002-09-12 2010-04-27 Ferag Ag Method and a device for processing and separating an imbricate formation of flexible, flat objects

Also Published As

Publication number Publication date
ES2185370T3 (es) 2003-04-16
KR100602485B1 (ko) 2006-07-19
BR9912022A (pt) 2001-04-03
WO2000002517A1 (fr) 2000-01-20
EP1096914A1 (fr) 2001-05-09
AR019897A1 (es) 2002-03-20
DE59903034D1 (de) 2002-11-14
CN1303258A (zh) 2001-07-11
US6364143B1 (en) 2002-04-02
HK1035315A1 (en) 2001-11-23
JP2002520093A (ja) 2002-07-09
KR20010043522A (ko) 2001-05-25
DE19831235C1 (de) 2000-03-16
ATE225639T1 (de) 2002-10-15

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