EP1384466A1 - Bouteille de plastique destinée à recevoir un fluide, notamment une solution de nutrition entérale - Google Patents

Bouteille de plastique destinée à recevoir un fluide, notamment une solution de nutrition entérale Download PDF

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Publication number
EP1384466A1
EP1384466A1 EP20020016516 EP02016516A EP1384466A1 EP 1384466 A1 EP1384466 A1 EP 1384466A1 EP 20020016516 EP20020016516 EP 20020016516 EP 02016516 A EP02016516 A EP 02016516A EP 1384466 A1 EP1384466 A1 EP 1384466A1
Authority
EP
European Patent Office
Prior art keywords
plug
plastic bottle
bottle according
spike
bottle
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Withdrawn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
EP20020016516
Other languages
German (de)
English (en)
Inventor
Bernd Dr. 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 Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
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 Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Priority to EP20020016516 priority Critical patent/EP1384466A1/fr
Publication of EP1384466A1 publication Critical patent/EP1384466A1/fr
Withdrawn legal-status Critical Current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
    • A61J1/1475—Inlet or outlet ports
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1418—Threaded type
    • 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/18—Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
    • B65D51/20—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
    • 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
    • A61J1/1468—Containers characterised by specific material properties

Definitions

  • the invention relates to a plastic bottle for holding a liquid, especially a solution for enteral nutrition.
  • Systems are known for enteral nutrition, which contain a container for receiving the nutrient solution, a transfer device connected to the container and one the transfer device connected probe over which the patient Nutrient solution is applied in the stomach.
  • the nutrient solution bags are made of oxygen-tight materials with a low permeation coefficients, which are hot sterilizable, so that after Filling the aseptic or low germ count is ensured. Because of their low In practice, the pouches have weight and ease of use proven.
  • plastic bottles are also known, which are used in extrusion or Injection blow molding can be produced.
  • Aroma barriers are generally plastics with a multilayer structure used.
  • Preferred barrier materials are EVOH and PA.
  • Coated plastics are now available, almost have similar barrier properties to glass.
  • PET is mostly used as a polymer compared to polyolefins has a significantly better barrier effect.
  • the disadvantage is that a Hot sterilization with steam or water for bottles made of coated PET not possible. In this respect, such plastic bottles are for inclusion enteral nutrient solution can only be used if the filling is in the sterile Packaging takes place under aseptic conditions.
  • the invention has for its object a plastic bottle for receiving a liquid, especially an enteral nutrient solution, to create their Aseptic or low germ count even after production and maintains one offers great comfort and a high level of safety for the user.
  • the port system of the plastic bottle according to the invention has a Bottle with sterile sealing stopper and a cover for the Plug on, with the plug or cover as one the spike of the connection system receiving guide piece is formed.
  • the plug is connected to one of the Spike pierceable weakening zone.
  • the bottle can be used both immediately after Manufacturing as well as sterile after filling. So that's one Separate manufacture of the bottle regardless of what is possible offers economic advantages.
  • the stopper should be such that, on the one hand, a sterile closure guaranteed and on the other hand the plug is easy to loosen.
  • the plastic bottle can be manufactured using the known injection blow molding process become. This process involves the manufacture of the bottle mouth as Preform in the injection molding process and the subsequent training of Bottle body in the blowing process. Then the coating of the injection-blown bottle. Since the blowing process under radiant heat at a Temperature of about 120 ° C, the plastic bottle can be considered almost sterile be considered. Also a coating process under plasma after the Blowing the bottle body to improve the barrier increases sterility. This sterility is ensured by the immediate closure of the bottle with the stopper maintained. Through the closure and with the aseptic filling, the Hot sterilization is no longer necessary, as is the case with the known materials comparable barrier effect with glass, is not possible.
  • the Sealing plug on an outer cylindrical portion which in the Bottle body can be used sealingly.
  • On the outer cylindrical section adjoins an outer annular section, which on the outer edge of the Bottle body lies sealingly. This plug can be easily released and seals securely.
  • the plug as a guide piece receiving the spike of the connection system is formed.
  • the plug preferably has an inner one cylindrical section that is concentric in the outer cylindrical Section is arranged.
  • the pierceable weakening zone is preferred arranged sunk in the inner cylindrical portion. The room in front of the The weakened zone is then kept sterile and sterile by the cover.
  • the So bottle not only offers advantages in terms of production technology, but also that required microbiological safety is guaranteed.
  • the cover for the sealing plug can be a screw cap or a film his.
  • the screw cap has the advantage that the sealing plug is secure can be jammed.
  • the screw cap preferably has a cylindrical portion Shot of the spike on.
  • the cylindrical section is preferably behind outside, but can also protrude inside, and is preferably with one
  • the break-off part is closed, not only for the bacterial protection of the puncture site serves, but also represents a tamper-evident closure.
  • the sealing plug is made of an oxygen-tight material with a low permeation coefficient.
  • the area-related permeation coefficient should be less than 30 cc / m 2 d bar, preferably less than 1 cc / m 2 d bar.
  • the overall barrier of the bottle which is predetermined by the bottle material or the coating of the bottle, should not deteriorate by more than a factor of 2 due to the closure.
  • barrier in the embodiment with the screw cap as the cover required barrier can also be created in that between Screw cap and sealing plug a sealing washer from one oxygen-tight material with a low permeation coefficient is inserted.
  • the same result if the film is made of an oxygen-tight material.
  • the sealing plug Foil preferably designed as a tear-off tab.
  • the plastic bottle consists of a bottle belly, bottle neck and Bottle body 1 and a port system 2.
  • Figure 1 shows a sectional view of the bottle mouth of the plastic bottle with port system 2.
  • the bottle body consists of an oxygen-tight plastic with a low permeation coefficient.
  • the plastic is a polymeric substrate, for example PET, which is coated with a non-polymer, for example SiO x .
  • the bottle mouth 1 has a peripheral edge 1a.
  • the port system 2 comprises a plug 3 and a screw cap 4.
  • the spike is inserted into the guide piece 7 of the plug 3, and the plug 3 is pierced with the spike.
  • An internal thread 11a is provided on the inside of the screw cap 4, while an external thread 11b is provided on the outside of the bottle mouth 1 above the annular extension 1a.
  • the screw cap 4 holds the plug 3 in a clamped manner.
  • the stopper consists of oxygen-tight material with a low permeation coefficient, for example less than 30 cc / m 2 d bar, preferably less than 1 cc / m 2 d bar. It has an outer cylindrical section 5, which sits sealingly in the bottle mouth 1.
  • An outer annular section 6 adjoins the outer cylindrical section and lies sealingly on the outer edge of the bottle mouth.
  • the sealing plug 3 has an inner cylindrical section 7, which is arranged concentrically in the outer cylindrical section 5.
  • the inner cylindrical section 7 serves as a guide piece for receiving a spike, not shown, of a connection system for transferring the enteral nutrient solution.
  • the inner cylindrical section 7 is closed with a base piece 8 which has a weakening zone 9 which is delimited by a circular predetermined breaking line 10.
  • the plastic bottle is manufactured in the known injection blow molding process.
  • the bottle mouth 1 is used as a preform in the injection molding process manufactured, with the injection molding process very tight component tolerances let achieve.
  • the bottle body is injection molded made, the bottle body under radiant heat at about 120 ° C and high pressure is inflated through the bottle mouth. Because of the high The temperature of the bottle body is almost sterile. This makes sterility maintain that the bottle body immediately after manufacture with the stopper is closed.
  • the Bottle can now be filled aseptically with the known processes, whereby the The stopper is only removed immediately before the filling process. Directly after filling, the bottle mouth is closed again with the stopper. Finally, the screw cap is screwed on.
  • FIG. 2 shows an alternative embodiment of the port system of the plastic bottle of Figure 1.
  • the corresponding parts are provided with the same reference numerals.
  • the embodiment of FIG. 2 differs from the embodiment of FIG. 1 in that an additional sealing washer 12 made of an oxygen-tight material with a low permeation coefficient, for example less than 30 cc / m 2 d bar, preferably less than 1 cc / m 2 d bar, is inserted between screw cap 4 and plug 3.
  • the sealing plug itself is made of PP, ie not of an oxygen-tight material. Such materials are easier to manufacture by injection molding and have greater flexibility than the known barrier materials.
  • FIG 3 shows another embodiment of the plastic bottle.
  • the corresponding parts are again with the same reference numerals Mistake.
  • the embodiment differs from the embodiment according to Figure 1 by the shape of the plug 3 'and the screw cap 4 '.
  • the screw cap 4 ' has a tubular section 13 External thread 14, which protrudes outwards.
  • the tubular section 13 receives a cylindrical portion 15 which serves as a guide for the spike.
  • the guide piece 15 is with a break-off part 16 with two wing-shaped Lugs 16a, 16b closed.
  • the plug 3 has a bottom part 17 with a central recess 18, which is closed by a base piece 19, which again via a Attenuation zone 20 has an annular line of weakness is limited.
  • the screw cap is required to connect the spike 4 'not to be removed.
  • the spike is removed after removing the break-off part 16 inserted into the guide piece 15 and the sealing plug 3 ' pierced.
  • FIG. 4 shows an exemplary embodiment of the plastic bottle with a port system, which differs from the embodiment according to FIG. 1 in that that instead of a screw cap, a film 21 designed as a tear-off tab is provided, which is welded to the top of the sealing plug 3.
  • the Foil 21 is made of oxygen-tight material with a low Permeation coefficient, so that the sealing plug from more flexible Materials with poorer barrier properties can exist.
  • the film and plug can be welded using the known ultrasonic welding process respectively.

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)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Closures For Containers (AREA)
EP20020016516 2002-07-23 2002-07-23 Bouteille de plastique destinée à recevoir un fluide, notamment une solution de nutrition entérale Withdrawn EP1384466A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP20020016516 EP1384466A1 (fr) 2002-07-23 2002-07-23 Bouteille de plastique destinée à recevoir un fluide, notamment une solution de nutrition entérale

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20020016516 EP1384466A1 (fr) 2002-07-23 2002-07-23 Bouteille de plastique destinée à recevoir un fluide, notamment une solution de nutrition entérale

Publications (1)

Publication Number Publication Date
EP1384466A1 true EP1384466A1 (fr) 2004-01-28

Family

ID=29797168

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20020016516 Withdrawn EP1384466A1 (fr) 2002-07-23 2002-07-23 Bouteille de plastique destinée à recevoir un fluide, notamment une solution de nutrition entérale

Country Status (1)

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EP (1) EP1384466A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7896859B2 (en) 2005-10-20 2011-03-01 Tyco Healthcare Group Lp Enteral feeding set
CN104013528A (zh) * 2014-04-17 2014-09-03 上海洁诺德塑胶制品有限公司 口服液瓶
CN104491939A (zh) * 2015-01-14 2015-04-08 中国医学科学院北京协和医院 肠内营养液滴注辅助装置
EP2247274B1 (fr) * 2008-02-01 2016-10-26 Plümat Plate & Lübeck GmbH & Co. Bouchon de fermeture pour récipients

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4524809A (en) * 1983-01-29 1985-06-25 Sterimatic Holdings Limited Fitments for containers from which liquid is intended to be withdrawn by a hollow needle or tube
US5332113A (en) * 1989-11-30 1994-07-26 Elan Pharmaceutical Research Corporation Cap assembly
WO1996026681A1 (fr) * 1995-02-27 1996-09-06 Migada, Inc. Poche de perfusion avec orifice d'injection
FR2772727A1 (fr) * 1997-12-24 1999-06-25 Rvp Finance Joint anti-retour pour orifice de recipient
EP0960616A2 (fr) * 1998-05-16 1999-12-01 Bracco International B.V. Bouchon universel à utilisations multiples
EP0974330A2 (fr) * 1998-07-20 2000-01-26 Bracco International B.V. Connecteur universel pour utilisation multiple

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4524809A (en) * 1983-01-29 1985-06-25 Sterimatic Holdings Limited Fitments for containers from which liquid is intended to be withdrawn by a hollow needle or tube
US5332113A (en) * 1989-11-30 1994-07-26 Elan Pharmaceutical Research Corporation Cap assembly
WO1996026681A1 (fr) * 1995-02-27 1996-09-06 Migada, Inc. Poche de perfusion avec orifice d'injection
FR2772727A1 (fr) * 1997-12-24 1999-06-25 Rvp Finance Joint anti-retour pour orifice de recipient
EP0960616A2 (fr) * 1998-05-16 1999-12-01 Bracco International B.V. Bouchon universel à utilisations multiples
EP0974330A2 (fr) * 1998-07-20 2000-01-26 Bracco International B.V. Connecteur universel pour utilisation multiple

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7896859B2 (en) 2005-10-20 2011-03-01 Tyco Healthcare Group Lp Enteral feeding set
US8357136B2 (en) 2005-10-20 2013-01-22 Covidien Lp Enteral feeding set
EP2247274B1 (fr) * 2008-02-01 2016-10-26 Plümat Plate & Lübeck GmbH & Co. Bouchon de fermeture pour récipients
CN104013528A (zh) * 2014-04-17 2014-09-03 上海洁诺德塑胶制品有限公司 口服液瓶
CN104491939A (zh) * 2015-01-14 2015-04-08 中国医学科学院北京协和医院 肠内营养液滴注辅助装置
CN104491939B (zh) * 2015-01-14 2024-02-09 中国医学科学院北京协和医院 肠内营养液滴注辅助装置

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