EP0790051A2 - Flexible plastic container - Google Patents

Abstract

The container has at least four compartments (2,3,4,5). Each compartment has its own inlet opening (7,8,9,10). An outlet (12) feeds the liquids into the body into the intestines or via any other way. The compartments can be interconnected by valves (13,14,15) which can be opened from the outside. By selectively opening these valves, liquids in the compartments may be completely mixed.

Description

The invention relates to a plastic container for spatially separate storage and, if appropriate, sterilization of the ingredients of parenterals or enterals, comprising at least four compartments.

EP-0 295 204 B1 describes a container for medical use, in particular containers for infusions, consisting of a covering made of flexible, homogeneous, polymerized material with a three-part interior, the interior parts being separated from one another by sealing welds from the material of the covering and each Interior part is provided with a blocked passage which can be opened at will so that the contents of the interior part can flow into another, the container in its upper part two adjacent interior parts (3,4) and in its lower part an interior part (5) contains and is intended just before their use, for the absorption and subsequent mixing of lipids, amino acids and sugar, each interior part is provided with a lockable opening in order to supply the connection through it from the outside or to thereby empty its contents to the outside and the material the wrapping towards everyone he considered compound and their mixtures is chemically and biologically inert. After filling and sterilization, these bags are provided with an outer bag in which, for example, commercially available oxygen absorbers are integrated.

DE 94 01 288 U1 relates to a multi-chamber bag with at least two chambers arranged one above the other in the mixing phase and surrounded by an outer edge, which are separated from one another by at least one web and form an upper chamber and a mixing chamber, with at least one arranged in the web and by one locking device to be opened, closed connecting device between the chambers, which creates a flow connection between the chambers after opening, with at least one suspension opening at the upper edge region and with one at the mixing chamber arranged outlet device and a second, opposite the former outlet device and arranged in the peripheral region of the mixing chamber second suspension opening.

In the aforementioned plastic containers of the prior art, a further separation of the individual components of the parenterals or enterals is not possible due to the predetermined number of compartments. A spatially separated storage and, if necessary, selective sterilization of the contents of a flexible plastic bag is not possible due to the size and number of compartments and the arrangement of the connecting devices between the compartments. In addition, the admixture of other components such as vitamins, oligo elements or, for example, glutamine, which the doctor treating the doctor may prescribe on site in the hospital, is not possible.

Accordingly, the problem of the present invention is to provide an improved flexible plastic container for the spatially separate storage and optionally selective sterilization of the ingredients of parenterals or enterals, which is suitable, in addition to the essential essential components carbohydrates, amino acids and fats, also other components such as vitamins, oligo elements, electrolytes, trace elements or, for example, glutamine.

• wenigstens vier Kompartimente 2, 3, 4 und 5 sowie gegebenenfalls ein Kompartiment 6, die geeignet sind zur Aufnahme von Spurenelementen im Kompartiment 2, Kohlenhydraten im Kompartiment 3, Fetten im Kompartiment 4 und Aminosäurelösungen im Kompartiment 5 sowie gegebenenfalls Elektrolyten und/oder Vitaminen im Kompartiment 6 mit jeweils einer verschließbaren Einfüllöffnung 7, 8, 9 und 10 sowie gegebenenfalls 11;
• eine Auslauföffnung 12 zur Applikation des Gemisches der Inhaltsstoffe der Parenteralien oder Enteralien;
• steril von außen zu öffnende Verbindungseinrichtungen 13, 13', 14, 14' und 15, 15' sowie gegebenenfalls 16, 16' mit denen jeweils Strömungsverbindungen zwischen den Kompartimenten 2, 3, 4 und 5 sowie gegebenenfalls 6 herstellbar sind;
  wobei
  • die Volumenverhältnisse der Kompartimente 2, 3, 4 und 5 sowie gegebenenfalls 6 derart gewählt sind, daß bei Gebrauchslage mittels der Aufhängevorrichtung 17 eine vollständige Mischung aller Inhaltsstoffe in dem Kompartiment 5 durch Öffnen der Verbindungseinrichtungen 13, 13',14, 14' und 15, 15' sowie gegebenenfalls 16, 16' möglich ist;
  • das Volumenverhältnis des Kompartiments 2 zum Kompartiment 3 derart gewählt ist, daß bei Gebrauchslage mittels der Aufhängeeinrichtung 17 eine vollständige Mischung der Inhaltsstoffe der Kompartimente 2 und 3 in dem Kompartiment 3 durch Öffnen der Verbindungseinrichtung 13,13' möglich ist und
  • gegebenenfalls das Volumenverhältnis des Kompartiments 4 zum Kompartiment 6 derart gewählt ist, daß bei Gebrauchslage mittels der Aufhängevorrichtung 17 eine vollständige Mischung der Inhaltsstoffe der Kompartimente 4 und 6 in dem Kompartiment 4 durch Öffnen der Verbindungseinrichtung 16, 16' möglich ist.

In a first embodiment, the aforementioned problem of the present invention is solved by a flexible plastic container 1 for spatially separate storage and, optionally, selective sterilization of the ingredients of parenterals or enterals

• at least four compartments 2, 3, 4 and 5 and, if appropriate, a compartment 6, which are suitable for receiving trace elements in compartment 2, carbohydrates in compartment 3, fats in compartment 4 and amino acid solutions in compartment 5 and, if appropriate, electrolytes and / or vitamins in compartment 6, each with a closable filling opening 7, 8, 9 and 10 and optionally 11;
• an outlet opening 12 for application of the mixture of the ingredients of the parenterals or enterals;
• Connecting devices 13, 13 ', 14, 14' and 15, 15 ', which can be opened sterile from the outside, and optionally 16, 16', with which flow connections between compartments 2, 3, 4 and 5 and, if appropriate, 6 can be established;
  in which
  • the volume ratios of the compartments 2, 3, 4 and 5 and optionally 6 are chosen such that, in the position of use by means of the hanging device 17, a complete mixture of all ingredients in the compartment 5 by opening the connecting devices 13, 13 ', 14, 14' and 15, 15 'and optionally 16, 16' is possible;
  • the volume ratio of the compartment 2 to the compartment 3 is selected such that a complete mixing of the contents of the compartments 2 and 3 in the compartment 3 is possible by opening the connecting device 13, 13 'in the position of use by means of the suspension device 17 and
  • optionally the volume ratio of the compartment 4 to the compartment 6 is selected such that a complete mixing of the contents of the compartments 4 and 6 in the compartment 4 is possible by opening the connecting device 16, 16 'in the position of use by means of the suspension device 17.

With the help of the present invention, it is possible to fill the ingredients of the parenterals or enterals more selectively into the individual compartments, possibly partially only after prescription by the attending physician, and to subject them to targeted, that is to say in particular gradual, sterilization. In addition, it is thus possible to selectively mix ingredients adapted to the patient with one another in order to obtain homogeneous mixtures as possible without additional effort by the hospital staff. Of course, this presupposes that not in the delivery state filled compartments are sterile to enable sterile mixing of components.

1 to 4, a flexible plastic container 1 is shown, each comprising 5 compartments 2, 3, 4, 5 and 6. The compartments are suitable for the absorption of trace elements, carbohydrates, fats, amino acid solutions and electrolytes as well as vitamins. In particular, the volume ratios of the compartments are adapted such that compartment 2 for the absorption of trace elements, compartment 3 for the absorption of carbohydrates, compartment 4 for the absorption of fats, compartment 5 for the absorption of amino acid solutions and compartment 6 for the absorption of electrolytes and / or vitamins. The contents of the above-mentioned compartments are introduced into the flexible plastic container at the same time or in succession through the closable filler openings 7, 8, 9 and 10 and optionally 11. The connecting devices 13, 14, 15 and 16 are designed in the form of breaking valves or breaking pins which can be opened in a sterile manner from the outside.

The arrangement according to the invention therefore makes it possible, depending on the filling state (empty or filled) of the individual compartments, to carry out different sterilization processes in succession depending on the stability of the ingredients, in order to protect sensitive ingredients from high temperatures or high-energy radiation, for example. In this way, sterile ingredients can be filled into already sterile containers that have already been filled with other ingredients and have been treated using other sterilization processes.

To apply the mixture of ingredients to the bedside, the flexible plastic container 1 according to the invention has an outlet opening 12 which is arranged in the use position by means of the hanging device 17 at the lower edge region of the compartment 5.

With a minimum filling of the compartments with carbohydrates (3), fats (4) and amino acids (5), there are several possible uses for the hospital pharmacy.

First of all, it is possible to apply mixtures that contain only carbohydrates and amino acids. By filling the compartment 2 it is possible to selectively add additives to this mixture. The same applies to the application of mixtures that contain only fats and amino acids. According to the invention, the bags contain 3 carbohydrates in the compartment, 4 fats in the compartment and 5 amino acids in the compartment. By opening the connecting devices 14, 14 'in the position of use of the bag, a binary mixture of carbohydrates and amino acids is first produced. The ternary mixture is then produced by opening the connecting devices 15, 15 '.

The production of ternary mixtures of carbohydrates, fats and amino acids has the advantage over the prior art that, on the one hand, the mixture can be reached more quickly, without effort (pressing) and, moreover, provides very homogeneous mixtures. During application, the ingredients are released at a very uniform concentration due to the homogeneous mixture. This can be demonstrated, for example, by the little varying glucose concentration in the course of the rapid leakage of the mixture from the bag after the connection devices have been opened. Homogenization by intensive milling is no longer necessary compared to the prior art.

The hospital pharmacist also has the option of introducing one or more components into the empty compartments 2 and / or 6, for example glutamine, electrolytes, trace elements or vitamins. After being introduced into the sterile compartment, the pharmacist can first make one or more sterile partial mixtures while the final mixture is performed by the nurse on the patient's bed.

The container with 4 or 5 compartments thus has the advantage that the pharmacist is able to add other components (vitamins, electrolytes, oligo elements, etc.) in sterile compartments, without these coming into direct contact with the other components of the sachet contents, while the nurse on site at the patient's bed, if necessary, does not finally mix all components of the bag contents until a few days after the bags have been finally filled.

A number of different connecting devices are known in the prior art which separate the contents of compartments 2, 3, 4 and 5 and, if appropriate, 6 from one another and enable a mixture of the ingredients by opening from the outside. For the purposes of the present invention, the connecting devices 13, 14 and 15 and, if appropriate, 16 are therefore particularly preferably in the form of crushing valves or crushing pins. 3 and 4 each show plastic containers 1 in which the connecting devices 13 ', 14', 15 'and optionally 16' are designed in the form of peelable heat-sealed seams. In the latter variant, the seam which separates the contents of two compartments from one another is formed in such a way that the corresponding flow connection between the compartments is produced by tearing or pressing from the outside.

The individual compartments are preferably separated from one another by heat-sealed, non-peelable webs. These webs have the connection devices 13, 14 and 15 and optionally 16, which can be opened in a sterile manner from the outside, with which flow connections between the compartments 2, 3, 4 and 5 and optionally 6 can be produced. In addition to or instead of the connecting devices 13, 14 and 15 and optionally 16 of FIGS. 1 to 4, corresponding connecting devices (not shown) between compartments 3 and 4 or 2 and 6 are of course also possible, if these are connected by common webs. By changing the size ratios or by changing the course of the separating webs, further flow connections are also possible, which enable a direct mixing of the contents of compartment 2 with compartment 4 on the one hand or compartment 3 with compartment 6 or compartment 3 with compartment 4. However, the presence of one or more heat-sealed peelable seams between individual or multiple compartments, which are opened by the action of external pressure on the bags, is also possible.

The volume ratios of the compartments 2, 3, 4 and 5 and optionally 6 are chosen such that, in the position of use by means of the hanging device 17, a complete mixture of the ingredients in the compartment 5, which is then located below, by opening said connecting devices 13, 13 ', 14, 14 'and 15, 15' and optionally 16, 16 'is possible. A complete mixture of all ingredients in the compartment 5 without time-consuming kneading and kneading work by the hospital staff is particularly advantageous for practical handling of the flexible plastic container according to the invention.

The volume ratio of the compartment 2 to the compartment 3 is chosen such that a complete mixing of the contents of the compartments 2 and 3 in the compartment 3 is possible by opening the connecting device 13, 13 'in the position of use by means of the suspension device 17. It is thus possible to subject trace elements located in compartment 2 to a separate mixture with the carbohydrates of compartment 3 before the mixture reaches compartment 5 by opening connecting device 14, 14 '.

In the same way, in the event that the flexible plastic container 1 comprises the compartment 6, the volume ratio of the compartment 4 to Compartment 6 is selected such that a complete mixing of the contents of the compartments 4 and 6 in the compartment 4 is possible after opening the connecting device 16 in the position of use by means of the suspension device 17. It is thus possible to subject the fats in the compartment 4 with electrolytes and / or vitamins of the compartment 6 to a separate mixture by opening the connecting device 16, 16 'before opening the connecting device 15, 15' to mix these ingredients into the Compartment 5 arrives, the volume of which is sufficient to accommodate all of the ingredients of the aforementioned compartments. It is thus possible to mix all the ingredients in this compartment 5 with one another without the additional work of the clinic personnel solely by gravity.

In a preferred embodiment of the present invention, the container comprises four compartments 2, 3, 4 and 5, that is to say the flexible plastic container shown in FIGS. 1 to 4 is without the connecting web which carries the connecting device 16, 16 'and the associated filling opening 10 or 11 manufactured.

In a further preferred embodiment, also shown in FIGS. 1 to 4, of the present invention, the flexible plastic container has a further suspension device 18 in the region of the web between the connecting devices 14, 14 'and 15, 15'. This device, known per se from DE 94 01 288 U1, has the advantage that the relatively large, bulky plastic containers can be reduced in volume, at least during use and application to the patient. By folding down the upper half of the container comprising compartments 2, 3, 4 and optionally 6 after mixing the ingredients in compartment 5, it is possible to reduce the apparent volume of the flexible plastic containers.

2 shows an alternative embodiment of the plastic container according to the invention shown, in which the compartments 2 and 6 were spatially separated. This arrangement has the advantage that a separate opening of the connecting devices 13 and 16 is better possible.

The web 19 shown in FIGS. 3 and 4, which may carry the suspension device 18, prevents the direct mixing of the ingredients of the compartments 3 and 4, which is undesirable for reasons of stability, before the ingredients enter the compartment 5.

Another embodiment of the invention consists in the partially or completely filled plastic containers. It is particularly preferred to fill compartment 3 with carbohydrates, compartment 4 with fats and compartment 5 with amino acids. Due to the greater density of the carbohydrates in relation to amino acids, a particularly simple mixture of these components is possible.

The bags according to the invention are particularly preferably put on the market without additional outer bags. This is possible due to the excellent separation of interfering components.

Embodiments example

In a 5-chamber bag according to FIG. 2 containing a usual aqueous solution of trace elements (10 ml) in compartment 2, a 38.2% dextrose solution (655 ml) in compartment 3, a usual fat emulsion (365 ml) in compartment 4, in compartment 5, a common amino acid solution (640 ml) and in compartment 6, a common solution containing vitamins (10 ml), binary mixtures of trace elements and dextrose or, respectively, were first opened by opening the connecting devices 13 and 16 in compartments 3 and 4. Vitamins and fats made.

A ternary mixture of vitamins fat emulsion and amino acids in compartment 5 was then produced by opening the connecting device 15. After the complete emptying of the compartment 4, the connecting device 14 was opened and a mixture of all components in the compartment 5 was mixed. After the complete emptying of compartment 3, an infusion was simulated at a rate of 2.5 ml / min.

The quality of the mixture could be visually observed.

In order to evaluate the mixing ratio, the dextrose content was measured after various withdrawal times.

The values are shown in Table 1 below. Table 1 Time (min) Dextrose content (g / l) nominal value 148.8 g / l 0 148.0 2nd 150.4 5 149.6 10th 136.9 15 151.1 20th 150.8 30th 149.6 45 150.4 60 149.8 90 152.1 120 148.7 180 149.5 240 148.8 300 148.8 360 149.0 420 149.5 480 149.2 540 148.8 600 148.8 660 148.8

The table shows that a homogeneous mixture without further manipulation can be obtained if the amino acid solution is in the lower compartment and the breaking seal 15, which separates the fat emulsion from the amino acid solution, is broken first.

Comparative example

In a 5-chamber bag according to FIG. 2 containing the aqueous solution of trace elements (10 ml) in compartment 2, the amino acid solution (640 ml) in compartment 3, the fat emulsion (365 ml) in compartment 4, and the glucose solution (655 ml in compartment 5) ) and in compartment 6 the vitamin solution (10 ml).

Analogous to Example 1, binary mixtures in compartments 3 and 4 were first produced.

A ternary mixture of trace elements, amino acids and glucose in compartment 5 was then produced by opening the connecting device 14.

After the compartment 3 was completely emptied, the connecting device 15 was opened and the contents of the compartment 4 were run into the compartment 5.

It was found that there was no mixing of the amino acid solution and the dextrose on the one hand and the fat emulsion on the other. In each case there was a sharp dividing line between the two layers.

Claims (8)

Flexible plastic container (1) for spatially separate storage and, if necessary, selective sterilization of the ingredients of parenterals or enterals comprising at least four compartments (2), (3), (4) and (5) and optionally a compartment (6) which are suitable for taking up trace elements in the compartment (2), carbohydrates in the compartment (3), fats in the compartment ( 4) and amino acid solutions in the compartment (5) and optionally electrolytes and / or vitamins in the compartment (6), each with a closable fill opening (7), (8), (9) and (10) and optionally (11); an outlet opening (12) for application of the mixture of the ingredients of the parenterals or enterals; Connecting devices (13, 13 '), (14, 14') and (15, 15 '), which can be opened sterile from the outside, and optionally (16, 16') with which flow connections between the compartments (2), (3), ( 4) and (5) and optionally (6) can be produced;
in which the volume ratios of the compartments (2), (3), (4) and (5) and optionally (6) are selected such that, when in use, the suspension device (17) completely mixes all the ingredients in the compartment (5) by opening the connecting devices (13, 13 '), (14, 14') and (15, 15 ') and optionally (16, 16') are possible; the volume ratio of the compartment (2) to the compartment (3) is selected such that, when in use, the suspension device (17) completely mixes the contents of the compartments (2) and (3) in the compartment (3) by opening the connecting device ( 13) is possible and where appropriate, the volume ratio of the compartment (4) to the compartment (6) is selected such that, in the position of use, the suspension device (17) completely mixes the contents of the compartments (4) and (6) in the compartment (4) by opening the connecting device (16, 16 ') is possible. A container according to claim 1 comprising the compartments (2), (3), (4) and (5). Container according to claim 1 or 2, characterized by a further suspension device (18) in the region of the web between the connecting device (14, 14 ') and (15, 15'). Container according to one or more of claims 1 to 3, characterized in that the connecting devices (13,), (14) and (15) and optionally (16) are designed in the form of crushing valves and / or crushing pins. Container according to one or more of claims 1 to 3, characterized in that the connecting devices (13 '), (14') and / or (15 ') and optionally (16') are designed in the form of peelable heat-sealed seams. Container according to one or more of claims 1 to 5, characterized in that the compartment (3) contains carbohydrates, the compartment (4) fats and the compartment (5) amino acid solution. Container according to claim 6, characterized in that the compartment (2) contains vitamins, oligo elements, electrolytes or trace elements. Container according to claim 6 or 7, characterized in that the compartment (6) contains vitamins.

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