EP0295204B1 - Mehrkammerbehälter zur Aufbewahrung und nachfolgenden Mischung aktiver Komponenten - Google Patents

Mehrkammerbehälter zur Aufbewahrung und nachfolgenden Mischung aktiver Komponenten Download PDF

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Publication number
EP0295204B1
EP0295204B1 EP19880810325 EP88810325A EP0295204B1 EP 0295204 B1 EP0295204 B1 EP 0295204B1 EP 19880810325 EP19880810325 EP 19880810325 EP 88810325 A EP88810325 A EP 88810325A EP 0295204 B1 EP0295204 B1 EP 0295204B1
Authority
EP
European Patent Office
Prior art keywords
compartment
passage
envelope
container according
container
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.)
Revoked
Application number
EP19880810325
Other languages
English (en)
French (fr)
Other versions
EP0295204A1 (de
Inventor
Maurice Loretti
Pierre Vanat
Jacques Andre
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.)
Vifor Medical AG
Original Assignee
Vifor SA
Vifor Medical AG
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=4225101&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP0295204(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Vifor SA, Vifor Medical AG filed Critical Vifor SA
Priority to AT88810325T priority Critical patent/ATE65473T1/de
Publication of EP0295204A1 publication Critical patent/EP0295204A1/de
Application granted granted Critical
Publication of EP0295204B1 publication Critical patent/EP0295204B1/de
Anticipated expiration legal-status Critical
Revoked 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • 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
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3261—Flexible containers having several compartments
    • B65D81/3266—Flexible containers having several compartments separated by a common rupturable seal, a clip or other removable fastening device
    • 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
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts

Definitions

  • the subject of the invention is a container for medical use, in particular a container for infusions, comprising an envelope of flexible polymerized material divided into three compartments separated from each other by sealed seals of the material of the envelope and each provided with a closed passage which can be released at will to allow the content to be transferred from one compartment to another.
  • a known model of container with two compartments can be succinctly described as follows: the upper compartment, intended to contain an aqueous solution of amino acids, is provided at its top with a closable passage serving to introduce said solution and, at its base , a closed transfer passage opening into the lower compartment, intended to contain the glucose solution. After rupture of the closure, the sterile mixture of amino acids is transferred to the lower compartment, the final product then being able to flow through an evacuation passage, located at the base of the lower compartment.
  • Such containers are based on flexible polymerized material, polyethylene for example.
  • Such containers are not suitable, however, for the sterile storage and administration of more complex mixtures, such as ternary mixtures.
  • the invention makes it possible to fill this gap. It consists of a container as defined in claim 1.
  • the container 1, according to FIGS. 1 and 2 comprises an envelope of homogeneous flexible polymerized material divided into three compartments separated from one another by sealed welds of the material of the envelope and each provided with a closed passage can be released at will to allow the content to be transferred from one compartment to another.
  • This container 1 is characterized in that it comprises in its upper part, two adjacent compartments 3, 4 and, in its lower part, a compartment 5, in that it is intended for separate storage and then for subsequent mixing, just before use, lipids, amino acids and sugars, in that each compartment is provided with a closable passage allowing the compound to be introduced from the outside or, respectively, to evacuate its content towards the outside and in that the material of the envelope is chemically and biologically inert with respect to each of the compounds considered and their mixtures.
  • each upper compartment 3, 4 is provided with an introduction passage 7, 8 closable at its somnet and the lower compartment is provided with a closable evacuation passage 9 at its base , each of the two compartments of the upper part 3, 4 opening into the compartment of the lower part 5 by a closed passage 10, 11 located at its base.
  • each upper compartment 3, 4 is provided with an introduction passage 7 ′, 8 ′ which can be closed at its top and the compartment in the lower part is provided with a closed discharge passage 9 ′ at its base, compartment 3 comprising at its base a closed transfer passage 10 ′ opening into the adjacent compartment 4, the latter being provided at its base with a closed transfer passage 11 ′ opening into the lower compartment 5.
  • the introduction passages 7, 8 respectively 7 ′, 8 ′ are most generally rigid or semi-rigid and welded to the material of the envelope. They are most often closed after the introduction of the given compounds into their respective compartments, using any suitable means ensuring an absolutely tight seal resistant, preferably under the conditions of sterilization. It is the same with regard to the discharge passage 9, respectively 9 ′, the latter being able to be further either connected to a nozzle, or perforated by a hollow needle for discharging the ready-to-use mixture.
  • the transfer passages 10, 11 respectively 10 ′, 11 ′ may include rigid or semi-rigid parts depending on the circumstances. They can consist of a manually breakable tip, a tearable weld under the effect of lateral pressure or a ball tightened in a flexible tube and which can be expelled manually. Such passages use known techniques and can ensure, if necessary, the sterile transfer of the contents from one compartment to another. As a rule, they are welded to the material of the envelope.
  • the material of the envelope must meet several conditions. Essentially, it must be flexible, of homogeneous composition and chemically and biologically inert with respect to each of the compounds considered and their mixtures. It must also be weldable using the usual techniques such as hot welding, ultrasonic or high frequency and compatible with the common materials used to make the passages mentioned above. It must also be impermeable to liquids, gases and vapors and preferably transparent, although the latter condition is not essential.
  • the envelope 2 may consist of a single sheet of a polymerized material meeting the conditions listed above. Envelope 2 can also be made up of a composite sheet, double or even triple depending on the case, only the material in contact with the given compounds then having to be chemically inert with respect to these or their mixtures.
  • polystyrene-ethylene-butyl examples include polyethylene, polypropylene, blocked polyether polyamide or mixtures of polyethylene and styrene-ethylene-butyl, polyethylene and ethylene-vinyl acetate , linear polyethylene, polypropylene and styrene-ethylene-butyl.
  • a single sheet or, as the case may be, the inner layer of a composite sheet is preferably formed.
  • complex materials constituting composite sheets the following may be mentioned: polyamide-polypropylene (PA / PP), linear polyamide-polyethylene, low density or high density (PA / PE) for example.
  • the container of the invention can be used as follows.
  • compartment 3 of the container according to FIG. 1 an emulsion based on lipids (essentially triglycerides) assimilated by the human body is introduced.
  • compartment 4 an aqueous solution of essential amino acids is introduced and, in the lower container 5, an aqueous solution of glucose, for example at 40% in H2O.
  • the introduction of these liquids is carried out according to the usual techniques, through the passages 7, 8 and 9 respectively, which are then closed in a sealed manner, after introduction.
  • the container thus filled can then be sterilized in an autoclave (temperature> 100 ° C) and stored as is for several months, even several years.
  • the procedure is as follows: the breakable passage 11 is broken manually and the amino acid solution is passed into the lower compartment 5.
  • the mixture can be activated by trituration of the compartment 5.
  • the procedure is identical with the breakable passage 10, passing the lipid emulsion into compartment 5.
  • the resulting mixture ready for use, can be administered after the nozzle 9 would have been connected to an infusion probe for example.

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Package Specialized In Special Use (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Claims (7)

1. Behälter zur medizinischen Verwendung, insbesondere Behälter für Infusionen, bestehend aus einer Umhüllung aus flexiblem, homogenem, polymerisiertem Material, mit dreigeteiltem Innenraum, wobei die Innenraumteile voneinander durch Dichtschweissungen aus dem Material der Umhüllung getrennt sind und jeder Innenraumteil mit einem abgesperrten Durchlass versehen ist, der willentlich geöffnet werden kann, damit der Inhalt eines Innenraumteiles in einen anderen fliessen kann, dadurch gekennzeichnet, dass der Behälter in seinem oberen Teil zwei benachbarte Innenraumteile (3, 4) und in seinem unteren Teil einen Innenraumteil (5) enthält, und dadurch, dass er, gerade vor ihrer Verwendung, zur Aufnahme und anschliessenden Mischung von Lipiden, Aminosäuren und Zuckern bestimmt ist, sowie dadurch, dass jeder Innenraumteil mit einer absperrbaren Oeffnung versehen ist, um von aussen durch sie die Verbindung zuzuführen oder um seinen Inhalt dadurch nach aussen zu entleeren, und des weiteren dadurch, dass das Material der Umhüllung gegenüber jeder betrachteten Verbindung und ihren Gemischen chemisch und biologisch inert ist.
2. Behälter nach Patentanspruch 1, dadurch gekennzeichnet, dass die absperrbare Zuführöffnung eines jeden oberen Innenraumteiles (3,4) an dessen obersten Ende (7, 8) angeordnet ist, und dass die absperrbare Auslassöffnung (9) des unteren Innenraumteiles an dessen unterem Ende angeordnet ist, und dass jede der beiden Innenraumteile des oberen Teiles (3 und 4) in den Innenraumteil des unteren Teiles (5) mit einer an ihren unteren Enden angeordneten, absperrbaren Oeffnung (10, 11) einmündet.
3. Behälter nach Patentanspruch 1, dadurch gekennzeichnet, dass die absperrbare Zuführöffnung eines jeden oberen Innenraumteiles (3, 4) an dessen obersten Ende (7′, 8′) angeordnet ist, und dass die absperrbare Auslassöffnung (9′) des unteren Innenraumteiles an dessen unterem Ende angeordnet ist, wobei der Innenraumteil (3) an seinem unteren Ende eine abgesperrte Oeffnung (10′) aufweist, die in den benachbarten Innenraumteil (4) einmündet, wobei letzterer an seinem unteren Ende mit einer abgesperrten Uebertrittsöffnung (11′) versehen ist, die in den unteren Innenraumteil (5) mündet.
4. Behälter nach einem der Patentansprüche 1 bis 3, dadurch gekennzeichnet, dass die abgesperrten Uebertrittsöffnungen (10, 11, 10′, 11′) von Hand ausbrechbar sind.
5. Behälter nach einem der Patentansprüche 1 bis 4, dadurch gekennzeichnet, dass das mit den Verbindungen in Kontakt stehende Material der Umhüllung (2) Polypropylen ist.
6. Behälter nach einem der Patentansprüche 1 bis 5, dadurch gekennzeichnet, dass die Umhüllung (2) eine einfache Folie ist.
7. Behälter nach einem der Patentansprüche 1 bis 5, dadurch gekennzeichnet, dass die Umhüllung eine Verbundfolie ist.
EP19880810325 1987-05-29 1988-05-24 Mehrkammerbehälter zur Aufbewahrung und nachfolgenden Mischung aktiver Komponenten Revoked EP0295204B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT88810325T ATE65473T1 (de) 1987-05-29 1988-05-24 Mehrkammerbehaelter zur aufbewahrung und nachfolgenden mischung aktiver komponenten.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH2066/87 1987-05-29
CH02066/87A CH686778A5 (fr) 1987-05-29 1987-05-29 Récipient destiné au stockage séparé de composés actifs et à leur mélange subséquent.

Publications (2)

Publication Number Publication Date
EP0295204A1 EP0295204A1 (de) 1988-12-14
EP0295204B1 true EP0295204B1 (de) 1991-07-24

Family

ID=4225101

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19880810325 Revoked EP0295204B1 (de) 1987-05-29 1988-05-24 Mehrkammerbehälter zur Aufbewahrung und nachfolgenden Mischung aktiver Komponenten

Country Status (7)

Country Link
US (1) US4997083A (de)
EP (1) EP0295204B1 (de)
JP (1) JPH07106755B2 (de)
AT (1) ATE65473T1 (de)
CH (1) CH686778A5 (de)
DE (1) DE3863849D1 (de)
ES (1) ES2024048B3 (de)

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EP2386284A1 (de) 2010-05-10 2011-11-16 B. Braun Melsungen AG Form
EP2386283A1 (de) 2010-05-10 2011-11-16 B. Braun Melsungen AG Befüllen
EP2386286A1 (de) 2010-05-10 2011-11-16 B. Braun Melsungen AG Handhabung

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CH686778A5 (fr) 1996-06-28
US4997083A (en) 1991-03-05
ATE65473T1 (de) 1991-08-15
JPS63317481A (ja) 1988-12-26
EP0295204A1 (de) 1988-12-14
ES2024048B3 (es) 1992-02-16
JPH07106755B2 (ja) 1995-11-15
DE3863849D1 (de) 1991-08-29

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