EP0295204B1 - Multiple chamber container for separate storage and subsequent mixture - Google Patents

Abstract

The container (1) is intended for the separate storage of active compositions, especially of liquids or solutions, and for their subsequent mixing just before use. It comprises at least three compartments (3, 4, 5) separated from one another by leakproof seams (6) of the material of the envelope (2), sealable inlet passages (7, 8), sealed transfer passages (10, 11) and a sealable outlet passage (9). The envelope is made of a polymerized and homogeneous flexible material which is chemically inert to each of said compositions and to their mixtures.

Description

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.

In the pharmaceutical field, and more precisely in the field of solutions for infusions, flexible bags have been used for some time for the administration of mixtures of amino acids and glucose. Since such mixtures cannot be subjected as such to sterilization (possibility of Maillard reactions), the amino acids and the glucose solution should be sterilized and stored separately. In order to ensure mixing, then administration of the latter under conditions of absolute sterility, a container such as a flexible bag with two compartments is advantageously used.

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.

In patent specification WO-A-8,301,569, a flexible bag with three compartments is described, allowing three solutions to be stored separately. However, due to its geometry, this container does not allow the production of a perfectly homogeneous ternary mixture. In addition, the compartments are superimposed and that of the middle is not provided with a closable passage allowing to introduce, from the outside, one of the three solutions. Therefore, a transit through the top (or bottom) compartment is mandatory to fill the middle compartment.

Although there are polymeric materials having all the desired qualities, in particular chemical inertness via with respect to amino acids and glucose and their mixture, it has not however been possible, until the present invention, to produce a container with three compartments for separately storing and sterilizing solutions of amino acids, lipids and sugars such as glucose, then administering the resulting mixture in the form of a solution for infusion.

The invention makes it possible to fill this gap. It consists of a container as defined in claim 1.

• La figure 1 représente, vue en plan, la première forme d'exécution.
• La figure 2 représente, vue en plan, la deuxième forme d'exécution.

The accompanying drawings illustrate, by way of example, two embodiments of the container according to the invention.

• Figure 1 shows, in plan view, the first embodiment.
• Figure 2 shows, in plan view, the second embodiment.

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.

In the preferred example according to Figure 1, 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.

In the embodiment according to FIG. 2, 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.

To achieve the intended goals, 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.

Among the polymerized materials advantageously meeting the conditions listed above, mention may be made of the following materials: high density 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. Using such materials, a single sheet or, as the case may be, the inner layer of a composite sheet is preferably formed. As 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.

Such materials have proven to be particularly well suited to the manufacture of the container according to the invention.

In one of its preferred embodiments, the container of the invention can be used as follows. In compartment 3 of the container according to FIG. 1, an emulsion based on lipids (essentially triglycerides) assimilated by the human body is introduced. In 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.

Before use in the form of an infusion, 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. After a new mixing of the components present, the resulting mixture, ready for use, can be administered after the nozzle 9 would have been connected to an infusion probe for example.

Claims (7)

1. A container for medical use, in particular a container for perfusions, comprising an envelope made of a polymerized, homogeneous flexible material which is divided into three compartments separated from one another by leaktight welds of the envelope material and each provided with an occluded passage which can be opened at will to enable the contents to be transferred from one compartment to another, characterized in that it has two adjacent compartments (3, 4) in its upper part and a compartment (5) in its lower part, in that it is intended for the separate storage and subsequent mixing, just before use, of lipids, amino acids and sugars, in that each compartment is provided with one occludable passage for introducing the compound from the outside and one for discharging its contents to the outside, and in that the envelope material is chemically and biologically inert towards each of the compounds in question and mixtures thereof.

2. A container according to Claim 1, characterized in that the occludable inlet passage of each upper compartment (3, 4) is located at its top (7, 8) and the occludable discharge passage (9) of the lower compartment is located at its base, each of the two compartments of the upper part (3 and 4) opening out into the compartment of the lower part (5) through an occluded passage (10, 11) located at its base.

3. A container according to Claim 1, characterized in that the occludable inlet passage of each upper compartment (3, 4) is located at its top (7′, 8′) and the occludable discharge passage (9′) of the lower compartment is located at its base, the compartment (3) having at its base an occluded transfer passage (10′) coming out into the adjacent compartment (4), the latter being provided at its base with an occluded transfer passage (11′) coming out into the lower compartment (5).

4. A container according to any one of Claims 1 to 3, characterized in that the occluded transfer passages (10, 11, 10′, 11′) can be broken by hand.

5. A container according to any one of Claims 1 to 4, characterized in that the material of the envelope (2) in contact with the compounds is polypropylene.

6. A container according to any one of Claims 1 to 5, characterized in that the envelope (2) is a single sheet.

7. A container according to any one of Claims 1 to 5, characterized in that the envelope (2) is a composite sheet.

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