EP0390898B1 - Recipient pour la conservation separee et sterile d'au moins deux substances et pour leur melange - Google Patents

Recipient pour la conservation separee et sterile d'au moins deux substances et pour leur melange Download PDF

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Publication number
EP0390898B1
EP0390898B1 EP19890911020 EP89911020A EP0390898B1 EP 0390898 B1 EP0390898 B1 EP 0390898B1 EP 19890911020 EP19890911020 EP 19890911020 EP 89911020 A EP89911020 A EP 89911020A EP 0390898 B1 EP0390898 B1 EP 0390898B1
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EP
European Patent Office
Prior art keywords
chamber
container according
container
tubular section
bag
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
EP19890911020
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German (de)
English (en)
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EP0390898A1 (fr
Inventor
Reinhold Herbert
Klaus Sommermeyer
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
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Application filed by Fresenius SE and Co KGaA filed Critical Fresenius SE and Co KGaA
Priority to AT89911020T priority Critical patent/ATE87197T1/de
Publication of EP0390898A1 publication Critical patent/EP0390898A1/fr
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Anticipated expiration legal-status Critical
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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
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • 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

Definitions

  • the invention relates to a container for separate sterile storage of at least two substances and for mixing these substances according to the preamble of claim 1 or 9.
  • the invention also relates to a method for producing a sterile medical mixing arrangement according to one of claims 1 to 18.
  • Medical storage bags are among others used for the storage of infusion solutions and must therefore be heat sterilizable above 100 ° C in order to meet the usual hygienic requirements. Such bags are known for example from DE-PS 32 00 264 or DE-PS 33 05 365.
  • These can be two liquid components that are mixed before the infusion or powdered medications, such as Antibiotics or cytostatics that are in a carrier solution, e.g. an aqueous saline solution.
  • a carrier solution e.g. an aqueous saline solution.
  • Bags are known for the storage and subsequent mixing of liquid active ingredient and carrier liquid, which are based on the above-mentioned.
  • Storage bags are made. To form two chambers, these bags are welded in the middle, a pipe section and a break-off part closing the pipe section being arranged in the weld seam as a connection between the two chambers. The break-off part is broken off before the infusion and then falls into the interior of one chamber. The liquid can then be transferred from one chamber to the second chamber, while maintaining the required sterility.
  • Such an infusion bag consisting of two chambers is also known from German utility model 77 19 528.
  • Several infusion solutions can be stored and applied separately in this infusion bag.
  • the two chambers are separated from each other by welds, in which an easy-to-open breaking cannula is attached, which is divided into several parts.
  • Another problem is that the required sterilization of the plastic bag cannot prevent water vapor from diffusing through the bag wall into the inside of the bag.
  • the inside of most bags bond inseparably to one another during sterilization without filling. Since the powder, which can only be filled in after heat sterilization and which can be, for example, antibiotics or cytostatics, must be kept dry in the container, it would be necessary in a further production step to remove the diffused water again, which would be associated with the corresponding effort .
  • US-A-4,507,114 shows the arrangement of two interconnected flexible bags, the interior of which can be connected via a tube section which is closed by a break-off part in the non-operational state. The tube cutout is opened by breaking off the break-off part, so that the contents of the upper bag can flow into the lower bag.
  • This configuration may be functional in the case of liquids, but this configuration cannot be used in the desired mixture of a powdery substance with a liquid substance.
  • US-A-4,606,734 shows a flexible bag which is provided at its upper area with a tubular adapter into which a rigid container can be inserted. The contents of the rigid container can be passed into the flexible container by opening the adapter.
  • This embodiment does not meet the requirements, particularly with regard to sterility, since the adapter cannot be attached in a sterile manner. Furthermore, it is not possible to store or transport the container as a unit, in which two medical substances are kept sterile.
  • the object of the invention is to provide a container and a mixing arrangement which allows two media (powder and liquid) to be stored under sterile conditions and to be mixed with one another in a simple manner under sterile conditions.
  • the mixing arrangement according to the invention has a first chamber made of an essentially rigid material with a tube section, the end part of which is closed and designed as a break-off part.
  • the tube section is welded into the bag edge in such a way that the break-off part is located in the interior of the bag and, after breaking off, releases the first substance for filling into the first rammer.
  • the container according to the invention is first manufactured and then the first chamber is closed and radiation sterilization with e ⁇ or ⁇ rays of the entire container is carried out. This pre-sterilization is particularly important for the first chamber.
  • the aqueous solution or carrier solution is then poured into the second chamber and the latter is closed. This is followed by heat sterilization of the entire container, with the closed first chamber being re-sterilized at the same time.
  • the rigid material of the first chamber preferably consists of polycarbonate, rigid PVC or polypropylene, there is no risk that liquid will penetrate into the first chamber and thus spoil the powdery material.
  • the first chamber can then be opened while maintaining the sterile conditions and, under sterile conditions, for example under laminar flow, a powdered medicament can be introduced into the first chamber, which is then closed with a sterile stopper.
  • a powdered medicament can be introduced into the first chamber, which is then closed with a sterile stopper.
  • the previous heat sterilization can be carried out with an outer bag, which is removed during the introduction. The entire bag is thus sterile on the outside.
  • Such a way of filling is particularly advantageous in the case of powdered pharmaceutical substances which are sensitive to heat and may only be filled at room temperature.
  • the filled and sterilized container can be hung directly on the bedside, where a nurse or doctor only has to break off the break-off part before the infusion in order to get the to bring both substances together.
  • the break-off part falls into the second chamber, and at the same time opens the connection opening to the first chamber arranged above it, so that the powdered or liquid medicament slips down into the second chamber without any further manipulations and especially under sterile conditions.
  • the fact that the first chamber consists of a rigid material and is preferably funnel-shaped ensures that no powdery material remains in the first chamber.
  • the first chamber can also be rinsed out with the carrier solution.
  • an appropriate infusion tube is connected to the outlet opening, which is provided with a membrane and a cap or a pierceable insert.
  • the pipe section which establishes the connection between the first and the second chamber and the break-off part preferably consist of the same material as the first chamber.
  • the pipe section is preferably welded into the edge of the second chamber, which consists of a plastic bag, and the material of the pipe section can be welded in either directly with the bag material or via an intermediate layer made of an additional welding material (for example according to DE-PS 3305365).
  • the first chamber has a capacity of 2 to 50 ml and the second chamber a capacity of 50 to 250 ml.
  • the container according to the invention has a first chamber 2 and a second chamber 3.
  • the chamber serves to receive the powdery substance 17 and is closed with a stopper 9 and a crimp cap 11.
  • a closure can also be welded to the edge 16.
  • the chamber 2 is generally funnel-shaped and merges with its tapered end 15 into the pipe section 10, which is closed at its lower end with the break-off part 4.
  • the pipe section 10 is welded into the welding edge 5 of the second chamber 3.
  • This second chamber 3 preferably consists of a plastic film and contains the carrier solution 18.
  • This plastic bag 3 has a hanger 8 at the upper end.
  • the outlet opening 6 is located at the lower end of this bag.
  • a further pipe section 14 or a hose is inserted, which is closed at the lower end with a conventional connecting part 12 with a plug 9 'and a cap 11'.
  • the closure element is displaceable in the form of a formed on the second chamber 2, which is provided with an O-ring seal 22.
  • the piston In the sealing position shown in Figure 2a, the piston is in sealing engagement with the pipe section 10 and has a piston rod 20 which extends through the Interior of the first chamber 2.
  • the upper end of the first chamber 2 is closed by means of an elastic wall 21 which is held on an upper flange of the first chamber 2 by means of a retaining ring 23.
  • the piston rod 20 extends to the underside of the elastic wall 21.
  • FIG. 2b shows the open position of the first chamber 2, it being evident that the piston 19 or the piston rod 20 connected to it can be moved into the open position by an elastic, manually caused deformation of the elastic wall 21.
  • the piston rod 20 is guided in a manner not shown on the first chamber 2, for example by means of a separate spacer element, which at the same time also serves as a captive device to prevent the piston 19 from falling off the first chamber 2 in the open position.
  • FIG. 2 c shows a detailed view of the locking piston 19 as well as the O-ring seal 22 and the piston rod 20.
  • the rod 20 can be provided with a spacer 25, which in the example may consist of four star-shaped arms 26 which point radially outwards and are supported on the inner wall 27 of the cylindrical main part of the container 2 can.
  • a certain frictional force is applied, which holds the piston 19 securely in its closed and open position.
  • the closure device according to the invention is extremely simple to manufacture and can be actuated in a safe manner, it also being possible, if necessary, to move the piston 11 back from its open position shown in FIG. 2 back to its closed position, for which purpose pressure is applied to the end flange 16 is required, which prevents damage to the sealing portion 15, since it engages radially on the outside.

Abstract

Est décrit un récipient (1) pour la conservation séparée et stérile d'au moins deux substances (17, 18) et pour leur mélange, qui comporte une première chambre (2) destinée à recevoir une substance pulvérulente (17), et une deuxième chambre (3) destinée à recevoir un liquide (18). Tandis que la deuxième chambre (3) se compose de préférence d'un film plastique, la chambre (2) est réalisée dans un matériau rigide, de préférence du polycarbonate, du PVC dur ou du polypropylène. Les deux chambres (2, 3) communiquent par l'intermédiaire du tronçon de tube (10) qui est obturé par la partie cassante (4). Pour le mélange des deux substances (17, 18), la partie cassante (4) est rompue le long d'une ligne d'affaiblissement (7). Le mélange est prélevé par l'orifice de décharge (6). Ce récipient (1) permet une conservation séparée de deux substances (17, 18) et leur mélange dans des conditions stériles.

Claims (20)

  1. Récipient pour la conservation séparée et stérile d'au moins deux substances médicales et pour le mélange de ces substances, comportant une première chambre (2) et une seconde chambre (3) qui est en communication indétachable avec la première chambre (2), cette seconde chambre étant conformée en une poche faite d'une matière thermoplastique, la communication entre la première chambre (2) et la seconde chambre (3) s'effectuant par un bout de tube (10) dont la partie terminale est fermée et forme une partie à rompre (4) et qui est disposé dans le bord de la seconde chambre de telle sorte que seule la partie à rompre (4) se trouve dans l'espace intérieur de la seconde chambre, caractérisé en ce que la première chambre (2) est faite d'une matière rigide appropriée à un remplissage au moyen d'une substance pulvérulente, tandis que la seconde chambre (3) conformée en poche est prévue pour un remplissage au moyen d'un liquide, en particulier d'une solution aqueuse, que la seconde chambre (3) présente à l'extrémité inférieure une ouverture de sortie (6) qui est pourvue d'une pièce de soutirage (12) comportant un bouchon (9′) et un capuchon serti (11′) ou encore une membrane transperçable et que la première chambre (2) est fermée par un bouchon (9) et un capuchon serti (11).
  2. Récipient selon la revendication 1, caractérisé en ce que la première chambre (2) est faite de polycarbonate ou d'un PVC rigide ou de polypropylène.
  3. Récipient selon la revendication 1 ou 2, caractérisé en ce que la seconde chambre (3) est faite d'une feuille de polyoléfines, telles que le polyéthylène, le polypropylène, le poly-n-butylène, le polyisobutylène, le poly-4-méthylpenthène-1, le polyéthylène chlorosulfoné, le polystyrène, les polyéthylènes halogénés ou le polyméthacrylate de méthyle ainsi que leurs copolymères ou leurs polymères mixtes.
  4. Récipient selon l'une quelconque des revendications 1 à 3, caractérisé en ce que le bout de tube (10) et la partie à rompre (4) sont faits de la même matière que la première chambre (2).
  5. Récipient selon l'une quelconque des revendications 1 à 4, caractérisé en ce que le bout de tube (10) est soudé dans le bord (5) de la seconde chambre (3).
  6. Récipient selon l'une quelconque des revendications 1 à 5, caractérisé en ce que la première chambre (2) est conformée en entonnoir et se fond dans le bout de tube (10) par son extrémité conique (15).
  7. Récipient selon l'une quelconque des revendications 1 à 6, caractérisé en ce que la première chambre (2) a une capacité de 2 à 50 ml.
  8. Récipient selon l'une quelconque des revendications 1 à 7, caractérisé en ce que la seconde chambre (3) a une capacité de 50 à 250 ml.
  9. Récipient pour la conservation stérile et séparée d'au moins deux substances médicales et pour le mélange de ces substances, comportant une première chambre (2) et une seconde chambre (3) qui est en communication indétachable avec la première chambre (2), cette seconde chambre étant conformée en une poche faite d'une matière thermoplastique, la communication entre la première chambre (2) et la seconde chambre (3) s'effectuant par un bout de tube (10) dont la partie terminale est disposée fermée dans le bord de la seconde chambre (3), caractérisé en ce que la première chambre (2) est faite d'une matière rigide appropriée à un remplissage au moyen d'une substance pulvérulente tandis que la seconde chambre (3) conformée en poche est prévue pour le remplissage au moyen d'un liquide, en particulier d'une solution aqueuse, que la partie terminale du bout de tube (10) est formée par un élément de fermeture ayant la forme d'un piston de fermeture (19) qui est montée de manière à pouvoir se déplacer et qui peut être amené d'une position de fermeture à une position d'ouverture, le piston de fermeture (19) est guidé dans le bout de tube (10) et est relié à une tige de piston (20) qui est montée de manière à pouvoir se déplacer dans la première chambre (2), que la première chambre (2) est fermée à son extrémité supérieure par une paroi élastique (21) contre laquelle la tige de piston (20) s'appuie et qui peut être déformée à la main pour déplacer la tige de piston (20), et que la seconde chambre (3) présente à son extrémité inférieure une ouverture de sortie (6) qui est pourvue d'une pièce de soutirage (12) comportant un bouchon (9′) et un capuchon serti (11′) ou une membrane transperçable.
  10. Récipient selon la revendication 9, caractérisé en ce que le piston (19) est rendu étanche, dans la position de fermeture, à l'égard du bout de tube (10) à l'aide d'un joint torique d'étanchéité (22).
  11. Récipient selon la revendication 9 ou 10, caractérisé en ce que le piston (19) est maintenu dans la première chambre (2) d'une manière protégée contre toute perte.
  12. Récipient selon l'une quelconque des revendications 9 à 11, caractérisé en ce que la première chambre (2) est faite de polycarbonate ou de PVC rigide ou de polypropylène.
  13. Récipient selon l'une quelconque des revendications 9 à 12, caractérisé en ce que la seconde chambre (3) est faite d'une feuille de polyoléfines, telles que le polyéthylène, le polypropylène, le poly-n-butylène, le polyisobutylène, le poly-4-méthylpenthène-1, le polyéthylène chlorosulfoné, le polystyrène, les polyéthylènes halogénés ou le polyméthacrylate de méthyle ainsi que leurs copolymères ou leurs polymères mixtes.
  14. Récipient selon l'une quelconque des revendications 9 à 13, caractérisé en ce que le bout de tube (10) est soudé dans le bord (5) de la seconde chambre (3).
  15. Récipient selon l'une quelconque des revendications 9 à 14, caractérisé en ce que la première chambre (2) a la forme d'un entonnoir et se fond dans le bout de tube (10) par son extrémité conique (15).
  16. Récipient selon l'une quelconque des revendications 9 à 15, caractérisé en ce que la première chambre (2) est pourvue d'un bouchon (9) et d'un capuchon serti (11).
  17. Récipient selon l'une quelconque des revendications 9 à 16, caractérisé en ce que la première chambre (2) a une capacité de 2 à 50 ml.
  18. Récipient selon l'une quelconque des revendications 9 à 17, caractérisé en ce que la seconde chambre (3) a une capacité de 50 à 250 ml.
  19. Procédé de fabrication d'un dispositif de mélange médical stérile caractérisé par les opérations suivantes :
    - on confectionne un récipient selon l'une quelconque des revendications 1 à 18;
    - on ferme la première chambre (2) et on procède à la stérilisation de la totalité du récipient par exposition à un rayonnement;
    - on remplit d'un liquide la seconde chambre (3) et on la ferme;
    - on stérilise à chaud la totalité du récipient;
    - on ouvre, on remplit et on ferme la première chambre (2) dans des conditions stériles.
  20. Procédé selon la revendication 19, caractérisé en ce que l'ensemble du récipient est pourvu, avant la stérilisation à chaud, d'une poche enveloppante et est stérilisé à chaud avec cette poche enveloppante qui est retirée avant le remplissage de la première chambre (2).
EP19890911020 1988-10-11 1989-10-10 Recipient pour la conservation separee et sterile d'au moins deux substances et pour leur melange Revoked EP0390898B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT89911020T ATE87197T1 (de) 1988-10-11 1989-10-10 Behaelter zur getrennten, sterilen aufbewahrung mindestens zweier substanzen und zur vermischung dieser substanzen.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19883834566 DE3834566A1 (de) 1988-10-11 1988-10-11 Behaelter zur sterilen, getrennten aufbewahrung mindestens zweier substanzen und zur vermischung derselben
DE3834566 1988-10-11

Publications (2)

Publication Number Publication Date
EP0390898A1 EP0390898A1 (fr) 1990-10-10
EP0390898B1 true EP0390898B1 (fr) 1993-03-24

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ID=6364852

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19890911020 Revoked EP0390898B1 (fr) 1988-10-11 1989-10-10 Recipient pour la conservation separee et sterile d'au moins deux substances et pour leur melange

Country Status (9)

Country Link
US (1) US5257986A (fr)
EP (1) EP0390898B1 (fr)
JP (1) JPH03502657A (fr)
AU (1) AU617883B2 (fr)
DE (2) DE3834566A1 (fr)
DK (1) DK140390A (fr)
HU (1) HU210255B (fr)
NO (1) NO179693C (fr)
WO (1) WO1990003775A1 (fr)

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Also Published As

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DE3834566C2 (fr) 1993-07-08
HUT55217A (en) 1991-05-28
HU210255B (en) 1995-03-28
WO1990003775A1 (fr) 1990-04-19
EP0390898A1 (fr) 1990-10-10
AU4340589A (en) 1990-05-01
NO902569D0 (no) 1990-06-11
HU895716D0 (en) 1990-11-28
JPH03502657A (ja) 1991-06-20
DE58903890D1 (de) 1993-04-29
DK140390A (da) 1990-07-04
NO902569L (no) 1990-06-11
NO179693C (no) 1996-12-04
AU617883B2 (en) 1991-12-05
US5257986A (en) 1993-11-02
NO179693B (no) 1996-08-26
DK140390D0 (da) 1990-06-08
DE3834566A1 (de) 1990-04-12

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