EP0790051B1 - 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 necessary, 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 flexible, homogeneous, polymerized material, with three-part interior, the interior parts from each other by sealing welds from the The casing material is separated and each interior part is cordoned off Passage is provided, which can be opened at will so that the Contents of the interior part can flow into another, with the container in its upper part two adjacent interior parts (3,4) and in its lower Part contains an interior part (5) and just before use, for recording and then mixing lipids, amino acids and sugar is determined, each interior part is provided with a lockable opening, to bring the connection from outside through it or to its content thereby emptying outwards and the material of the casing opposite each compound and their mixtures chemically and biologically is inert. These bags are filled with and after sterilization Provide a pouch 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 in the Mixed phase arranged one above the other and surrounded by an outer edge Chambers that are separated from one another by at least one web and one form the upper chamber and a mixing chamber, with at least one in the web arranged and closed by an opening locking device Connection device between the chambers, which after opening a Creates flow connection between the chambers with at least one Hanging opening on the upper edge area and with one on the mixing chamber arranged outlet device and a second, the first-mentioned outlet device opposite and in Second suspension opening arranged circumferential region of the mixing chamber.

US 4,465,488 describes a flexible container for holding medical solutions or powders, which has a plurality of separate and sealed chambers. Flow connections between the chambers can be established by means of break valves which can be opened from the outside through the casing.
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 separate 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 further components such as vitamins, oligo elements or, for example, glutamic acid, 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, glutamic acid.

In a first embodiment, the aforementioned problem of the present invention is solved by a flexible plastic container (1) for spatially separated storage and optionally selective sterilization of the ingredients of parenterals or enterals
at least four compartments, namely a first compartment (2), a second compartment (3), a third compartment (4) and a fourth compartment (5) and optionally a fifth compartment (6), which are suitable for receiving trace elements in the first Compartment (2), carbohydrates in the second compartment (3), fats in the third compartment (4) and amino acid solutions in the fourth compartment (5) and optionally electrolytes and / or vitamins in the fifth compartment (6), each with a closable filler 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 in such a way that, when in use, a complete mixing of all the ingredients in the fourth compartment (5) by means of a suspension device (17) Opening of the connecting devices (13, 13 '), (14, 14') and (15, 15 ') and optionally (16, 16') is possible;
the volume ratio of the first compartment (2) to the second compartment (3) is selected such that in the use position by means of the hanging device (17) a complete mixture of the contents of the compartments (2) and (3) in the compartment (3) by opening the Connecting device (13) is possible and, if necessary, the volume ratio of the third compartment (4) to the fifth compartment (6) is selected such that a complete mixture of the contents of the compartments (4) and (6) in the use position by means of the suspension device (17) the compartment (4) is possible by opening the connecting device (16, 16 ').

It is particularly advantageous if the container has another one Suspension device (18) in the area of the web between the Connection device (14, 14 ') and (15, 15'), between the second and third compartments (3, 4) and the fourth Has compartment (5).

The connecting devices (13,), (14) and (15) and optionally (16) in the form of crushing valves and / or Breaking pin or also the connecting devices (13 '), (14') and / or (15 ') and optionally (16') in the form of peelable Heat seal seams should be formed.

For the purposes of the present invention, it is particularly advantageous if the compartment (3) carbohydrates, the compartment (4) fats and the compartment (5) contains amino acid solution.

Compartment (2) can then, for example, vitamins, oligo elements, Contain electrolytes or trace elements, being vitamins are advantageously contained in compartment (6).

With the help of the present invention it is possible to determine the ingredients of the Parenterals or Enterals more selective in the individual compartments, if necessary, only after prescription by the treating person Doctor, fill in and a targeted, that is, in particular step by step Subject to sterilization. In addition, it is therefore possible to Selectively mixing patient-adapted ingredients with each other homogeneous mixtures without any additional effort by the To get hospital staff. Of course, this presupposes that not in the delivery state Filled compartments are sterile to ensure sterile mixing of components to enable.

1 to 4, a flexible plastic container 1 is shown, each 5 compartments 2, 3, 4, 5 and 6 comprises. The compartments are for inclusion of trace elements, carbohydrates, fats, amino acid solutions and electrolytes as well as vitamins. In particular, the volume ratios the compartments adjusted so that the compartment 2 for receiving Trace elements, compartment 3 for the absorption of carbohydrates, the Compartment 4 for the absorption of fats, the compartment 5 for the absorption of amino acid solutions and compartment 6, if necessary, for inclusion of electrolytes and / or vitamins. The ingredients of Compartments mentioned are each through the closable filler openings 7, 8, 9 and 10 and optionally 11 simultaneously or in succession placed in the flexible plastic container. The connecting devices 13, 14, 15 and 16 are designed in the form of crushing valves or crushing pins, which can be opened sterile from the outside.

The arrangement according to the invention therefore makes it possible, depending on the state of filling (empty or filled) of the individual compartments different Sterilization process depending on the stability of the ingredients one after the other to perform, for example, sensitive ingredients from high Protect temperatures or high-energy radiation. So sterile Ingredients are filled into already sterile containers that are already with others Ingredients filled and treated by other sterilization processes are.

To apply the mixture of ingredients to the bedside, the invention flexible plastic container 1 has an outlet opening 12 which in Use position by means of the suspension device 17 at the lower edge area of the Compartment 5 is arranged.

With a minimum filling of the compartments with carbohydrates (3), fats (4) and amino acids (5) exist for the hospital pharmacy Applications.

First of all, the application of mixtures that are exclusively possible Contain 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 containing only fats and amino acids contain. 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 use position of the bag first becomes a binary mixture of carbohydrates and amino acids manufactured. Then by opening the connecting devices 15, 15 ' made the ternary mixture.

The production of temporary mixtures of carbohydrates, fats and amino acids has the advantage over the prior art that on the one hand Mixing can be achieved faster and without effort (pressing) and above provides very homogeneous mixtures. When applying the ingredients with a very even concentration, due to the homogeneous Mixture, dispensed. This can be seen, for example, from the little that varies Glucose concentration in the course of the rapid leakage of the mixture point out of the bag after opening the connection devices. On Homogenization through intensive milling is, compared to the prior art, not necessary anymore.

The hospital pharmacist also has the option of one or more To bring components into the empty compartments 2 and / or 6, for example Glutamine, electrolytes, trace elements or vitamins. After insertion In the sterile compartment, the pharmacist can first place one or make several sterile partial mixes during the final mix is performed by the nurse on the patient's bed.

The container with 4 or 5 compartments thus has the advantage that the pharmacist the addition of other components (vitamins, electrolytes, oligo elements etc.) is made possible in sterile compartments without these in come into direct contact with the other components of the bag contents, while the nurse may be on site at the patient's bed only a few days after the final filling of the bags the final Mix all components of the bag contents.

A number of different connecting devices are in the prior art known the contents of compartments 2, 3, 4 and 5 and, if appropriate 6 separate from each other and a mixture of Enable ingredients. Particularly preferred in the sense of the present The invention therefore relates to the connecting devices 13, 14 and 15 and, if appropriate 16 designed in the form of crushing valves or crushing pins. In the Fig. 3 and 4 are each shown plastic containers 1, in which the connecting devices 13 ', 14', 15 'and optionally 16' in the form of peelable Heat seal seams are formed. In the latter variant, the seam, which separates the ingredients of two compartments from each other that by tearing or pressing from the outside the corresponding flow connection is produced between the compartments.

The individual compartments are preferably not heat-sealed peelable bars separated from each other. These bars are sterile from the outside connecting devices 13, 14 and 15 to be opened and optionally 16 with which flow connections between the compartments 2, 3, 4 and 5 and possibly 6 can be produced. In addition to or instead of Connecting devices 13, 14 and 15 and optionally 16 of FIGS. 1 to 4 are of course also corresponding connection devices, not shown possible between compartments 3 and 4 or 2 and 6, if these are connected by common webs. By change the proportions or by changing the course of the dividers in addition, other flow connections possible, which are immediate Mixing the ingredients of compartment 2 with compartment 4 on the one hand or compartment 3 with compartment 6 or the compartment 3 with compartment 4. However, the presence is still there of one or more heat-sealed peelable seams / seams between individual or several compartments possible, which are caused by the action of external pressure on the bags can be opened.

The volume ratios of compartments 2, 3, 4 and 5 and, if necessary 6 are chosen such that in the use position by means of the suspension device 17 a complete mix of ingredients in the one below Compartment 5 by opening the connection means mentioned 13, 13 ', 14, 14' and 15, 15 'and optionally 16, 16' is possible. A complete Mixing of all ingredients in the compartment 5 without expensive Walk and kneading work by the clinic staff is of particular advantage for a practical handling of the flexible plastic container according to the invention.

The volume ratio of compartment 2 to compartment 3 becomes such chosen that in the position of use by means of the suspension device 17 a complete Mixture of ingredients of compartments 2 and 3 in the compartment 3 is possible by opening the connecting device 13, 13 '. Consequently it is possible to start with trace elements located in compartment 2 subject the carbohydrates of compartment 3 to a separate mixture, before the mixture by opening the connecting device 14, 14 'in the Compartment 5 arrives.

In the same way, in the event that the flexible plastic container 1 Compartment 6 comprises the volume ratio of the compartment 4 to Compartment 6 selected such that in the position of use by means of the suspension device 17 a complete mixture of the ingredients of the compartments 4 and 6 in the compartment 4 after opening the connecting device 16 is possible. It is thus possible to use the fats in compartment 4 Electrolytes and / or vitamins of compartment 6 are initially separate Mix before opening by opening the connecting device 16, 16 ' by opening the connecting device 15, 15 'the mixture of these ingredients reaches compartment 5, the volume of which is sufficient, all Include ingredients of the aforementioned compartments. So it is possible all ingredients in this compartment 5 with each other without additional Mixing the work of the clinic staff solely by gravity.

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

In a further preferred embodiment, likewise in FIGS. 1 to 4 shown, the present invention has the flexible plastic container further suspension device 18 in the area of the web between the Connecting devices 14, 14 'and 15, 15'. This in itself from DE 94 01 288 U1 known device has the advantage that a volume reduction the relatively large bulky plastic container at least during the Application and application to the patient is possible. 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 spatially apart were 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 be the Hanging device 18 carries, prevents the undesirable for reasons of stability direct mixing of the ingredients of compartments 3 and 4 before entry the ingredients in compartment 5.

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

The bags according to the invention are particularly preferred without additional ones Pouches put on the market. This is due to the excellent separation interfering components possible.

embodiments example

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

Then opened a ternary by opening the connector 15 Mixture of vitamins, fat emulsion and amino acids in compartment 5 manufactured. After the complete emptying of compartment 4, the Connection device 14 opened and a mixture of all components in the Compartment 5 received. After the compartment 3 has been completely emptied 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 determined according to different Withdrawal times measured.

The values are shown in Table 1 below. Time (min) Dextrose content (g / l)
Nominal value 148.8 g / l 0 148.0 2 150.4 5 149.6 10 136.9 15 151.1 20 150.8 30 149.6 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 when the amino acid solution is in the lower compartment and the crush seal 15, which is the fat emulsion from the amino acid solution separates, is broken first.

Comparative example

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

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

Then opened a ternary by opening the connector 14 Mixture of trace elements, amino acids and glucose in compartment 5 manufactured.

After compartment 3 was completely emptied, the Connection device 15 opened and the contents of compartment 4 in the Compartment 5 entered.

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 any case, there was one sharp dividing line between the two layers.

Claims (7)

1. A flexible plastic bag (1) for the spatially separated storage and optionally selective sterilization of the contents of parenteral or enteral nutrition, comprising
   at least four compartments, namely a first compartment (2), a second compartment (3), a third compartment (4) and a fourth compartment (5), and optionally a fifth compartment (6), which are capable of containing trace elements in the first compartment (2), carbohydrates in the second compartment (3), lipids in the third compartment (4) and amino acid solutions in the fourth compartment (5), and optionally electrolytes and/or vitamins in the fifth compartment (6), respectively having occludable inlet passages (7), (8), (9) and (10), and optionally (11);
   a discharge passage (12) for administering the mixture of said contents of parenteral or enteral nutrition;
   connecting means (13, 13'), (14, 14') and (15, 15'), and optionally (16, 16'), which can be opened from the outside under sterile conditions and which are capable of respectively providing fluid communications between compartments (2), (3), (4) and (5), and optionally (6);
   wherein
   the volume ratios between compartments (2), (3), (4) and (5), and optionally (6), are selected to enable thorough mixing of all contents in the fourth compartment (5) by opening connecting means (13, 13'), (14, 14') and (15, 15'), and optionally (16, 16'), in the position of use as provided by a suspension means (17);
   the volume ratio of the first compartment (2) to the second compartment (3) is selected to enable thorough mixing of the contents of compartments (2) and (3) in compartment (3) by opening connecting means (13, 13'), in the position of use as provided by suspension means (17); and
   optionally the volume ratio of the third compartment (4) to the fifth compartment (6) is selected to enable thorough mixing of the contents of compartments (4) and (6) in compartment (4) by opening connecting means (16, 16'), in the position of use as provided by suspension means (17).
2. The container according to claim 1, characterized by a further suspension means (18) in the region of the ridge between connecting means (14, 14') and (15, 15'), between the second and third compartments (3, 4) and the fourth compartment (5).
3. The container according to one or more of claims 1 or 2, characterized in that connecting means (13), (14) and (15) and optionally (16) are designed in the form of breakable valves and/or breakable bungs.
4. The container according to one or more of claims 1 or 2, characterized in that connecting means (13'), (14') and/or (15') and optionally (16') are designed in the form of peelable hot-seal welds.
5. The container according to one or more of claims 1 to 4, characterized in that compartment (3) contains carbohydrates, compartment (4) contains lipids, and compartment (5) contains an amino acid solution.
6. The container according to claim 5, characterized in that compartment (2) contains vitamins, oligoelements, electrolytes or trace elements.
7. The container according to claim 5 or 6, characterized in that compartment (6) contains vitamins.

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