CONTAINER ARRANGEMENT AND METHOD FOR FILLING THESE

Description

[0001] The present invention relates to a container arrangement comprising a first container in which a concentrate is located which is designed to form a ready-to-use dialysis solution or a component thereof when diluted with a solvent, preferably with pure water.

[0002] Furthermore, the present invention relates to such a container arrangement in which the first container is empty. For example, the first container in this case is a drainage bag of a peritoneal dialysis system in which used dialysis solution is collected.

[0003] It is known from the prior art to use a sterile solution containing water as a solvent, some physiological salts, buffers, and glucose for dialysis treatment of a patient. The main component of the solution is water, which constitutes the majority of the solution by volume and weight. During the manufacturing process, storage, and transport, large quantities of ultrapure water are moved. This not only presents handling and transport disadvantages, but also involves the additional energy consumption associated with transport and storage.From DE19510759A1 a container arrangement for producing fresh dialysis solution and / or receiving used dialysis solution is known, which container arrangement has an outer and an inner container, wherein the inner container is an elastic bag containing a concentrate which is designed to form a ready-to-use dialysis solution when diluted with water, wherein the bag is dimensioned such that it corresponds to the interior of the outer container without elastic deformation.

[0004] The present invention is based on the object of creating an easy-to-handle container assembly for preparing a dialysis solution and reducing the amount of water that needs to be moved during handling to prepare a dialysis solution. Furthermore, a further object of the present invention is to provide an improved drainage bag for peritoneal dialysis.

[0005] This object is achieved by a container arrangement having the features of claim 1.

[0006] According to this, it is provided that the container arrangement has a second container in which the first container is accommodated, wherein the first container has greater elasticity than the second container and wherein the first container is designed to expand as far as the second container. The present invention is therefore based on the idea of ​​arranging a first container in a second container, wherein the first container is designed to be elastic in such a way that it can expand as far as the second container when filled with a solvent, in particular with pure water (water for injection), or another liquid. Pure water is suitable for use in medical solutions, in particular for injection into the patient. Consequently, pure water is usually sterilized.

[0007] The first container thus has the task of holding the concentrate and the diluted, preferably ready-to-use dialysis solution or a portion thereof, and the second container has the task of providing structural strength to the container arrangement and limiting the expansion of the first container.

[0008] The present invention makes it possible to reduce the water content and provide a preferably liquid concentrate, which is preferably adequately packaged (stable, steam sterilizable, etc.). It is preferred if this concentrate can be refilled to a ready-to-use solution near or at the patient's location simply by adding ultrapure water via a special port.

[0009] Preferably, the second container does not come into contact with liquid and, in this case, does not have to fulfil any special properties with regard to the absorption of a liquid.

[0010] This makes it possible to separate or distribute the tasks (liquid absorption and structural strength) between the two containers, whose material can then be selected accordingly.

[0011] For example, it is conceivable for the second container to be flexible but not elastic. "Non-elastic" also means a case where there is very little elasticity. This elasticity is preferably so low that the second container limits the expansion of the first container when it is filled with solvent.

[0012] The first bag is preferably flexible and elastic. The film of the first bag preferably has a breaking elongation of 400-900% in both the longitudinal and transverse directions.

[0013] To prevent an insulating effect caused by an air cushion during heat sterilization of the container assembly, it is preferably provided that a vacuum is maintained between the first and second containers. The first container expands into this evacuated area when filled, preferably until it rests against the second container. The air between the two bags can be easily removed during production by welding / sealing under vacuum.

[0014] It is thus preferably provided that the second container represents a volume limitation in the expansion of the first container and provides structural strength to the container arrangement.

[0015] A particularly preferred embodiment results when the first and / or the second container is a bag.

[0016] The first and second containers can be connected to each other directly or indirectly at one or more locations. An indirect connection means that the first and second containers are fixed to a part of the container assembly, such as a connector for filling and emptying the first container, but are not directly connected to each other.

[0017] A direct connection of the two containers at one or more points or sides, e.g. by welding, is preferred.

[0018] A preferred connection of the containers is thus achieved by welding the containers.

[0019] It is conceivable that the first and second containers each have an upper and a lower end, and that the containers are connected, in particular welded, to one another at these two ends or at one of these ends. Other variants are also conceivable, such as welding the bags on only one side, i.e., on the right or left side.

[0020] Furthermore, the first container can be provided with a connector that leads from the interior of the first container to the exterior. This connector, or hose with a connector, serves to fill the first container with solvent or to empty the ready-to-use dialysis solution, or a portion thereof, from the expanded first container.

[0021] Preferably, the second container completely surrounds the first container.

[0022] The second container can serve as the outer packaging for the first container. One function of the outer packaging is to create a water vapor barrier. Therefore, the film of the second container preferably has a permeability of 0.2-5.0 g / (m2< *d) at 25°C and 40% relative humidity.

[0023] Preferably, the concentrate in the first container is in liquid form. In principle, the use of a solid concentrate or a combination of a solid and a liquid concentrate is also conceivable and encompassed by the invention.

[0024] It is also conceivable that the second container is partially or completely folded or rolled around the first container, so that a space-saving container arrangement is achieved, particularly during storage and transport.

[0025] The present invention relates to a method for filling a container assembly according to one of claims 1 to 12 with solvent, in particular with pure water, wherein the solvent is poured into the first container, which expands in the process. Any other liquid can also be used instead of the solvent.

[0026] Preferably, the filling is carried out in such a way that the first container expands up to the second container, which represents a structural limitation of the expansion of the first container.

[0027] Sufficient miscibility of the ingredients of typical dialysis solutions (glucose, salts, buffers) at the required concentration can be achieved with a 10-fold (or higher) concentrated solution. Accordingly, the concentrate in the first container is preferably 10-fold or higher concentrated.

[0028] Preferably, the concentrate contains at least one osmotic agent and / or one or more electrolytes and / or one or more buffers and particularly preferably, apart from the total water required, all the components required to produce a dialysis solution.

[0029] It has also proven advantageous in practice if the first container is a drainage bag of a peritoneal dialysis system.

[0030] In such an application, the second container preferably has a perforated and / or mesh-like structure, which forms a reliable support structure for the first container with preferably minimal material consumption. For example, the second container can be made as a mesh bag and / or from threads, strips, or cords. The use of such a second container makes it possible to manufacture the first container / drainage bag with particularly thin walls and / or from a particularly elastic material, since the second container supports and protects the first container.

[0031] It should be noted here that the terms "a" and "an" do not necessarily refer to exactly one of the elements, although this is a possible interpretation, but can also refer to a plurality of the elements. Likewise, the use of the plural also includes the presence of the element in question in the singular, and conversely, the singular also encompasses several of the elements in question.

[0032] In other words, the invention can also be described as follows: Aspect 1 of the invention relates to a container arrangement with a first container in which a concentrate is located which is designed to form a ready-to-use dialysis solution or a component thereof when diluted with a solvent, preferably with pure water (water for injection), characterized in that the container arrangement has a second container in which the first container is received, wherein the first container has greater elasticity than the second container and wherein the first container is designed to expand up to the second container. Aspect 2 of the invention relates to a container arrangement according to aspect 1, characterized in that the second container is flexible but not elastic and / or that the first bag is flexible and elastic. Aspect 3 of the invention relates to a container arrangement according to aspect 1 or 2, in that there is a vacuum between the first and the second container.Aspect 4 of the invention relates to a container arrangement according to one of the preceding aspects, characterized in that the second container represents a volume limitation during the expansion of the first container and provides structural strength to the container arrangement. Aspect 5 of the invention relates to a container arrangement according to one of the preceding aspects, characterized in that the first and / or the second container is a bag. Aspect 6 of the invention relates to a container arrangement according to one of the preceding aspects, characterized in that the first and the second container are directly or indirectly connected to one another at one or more points. Aspect 7 relates to a container arrangement according to aspect 6, characterized in that the connection is made by welding.Aspect 8 of the invention relates to a container arrangement according to one of the preceding aspects, characterized in that the first and the second container have an upper and a lower end and that the containers are connected to one another at these two ends or at one of these ends, in particular welded. Aspect 9 of the invention relates to a container arrangement according to one of the preceding aspects, characterized in that the first container is provided with a connector which leads from the interior of the first container to the outside. Aspect 10 of the invention relates to a container arrangement according to one of the preceding aspects, characterized in that the second container represents the outer packaging of the first container. Aspect 11 of the invention relates to a container arrangement according to one of the preceding aspects, characterized in that the concentrate is in liquid form.Aspect 12 of the invention relates to a container arrangement according to one of the preceding aspects, characterized in that the second container is partially or completely folded or rolled around the first container. Aspect 13 of the present invention relates to a method for filling a container arrangement according to one of aspects 1 to 12 with solvent, in particular with pure water (water for injection), wherein the solvent is filled into the first container, which expands in the process. Aspect 14 relates to a method according to aspect 13, characterized in that the filling is carried out in such a way that the first container expands up to the second container, which represents a structural limitation of the expansion of the first container.

[0033] Further details and advantages of the invention are explained in more detail with reference to an embodiment shown in the drawing.

[0034] They show: Figure 1: a schematic view of a container arrangement in a first embodiment, Figure 2: views of the container arrangement according to Figure 1 in different stages of filling the first container with solvent, Figure 3: a schematic view of a container arrangement in a second embodiment Figure 4: views of the container arrangement according to Figure 3 in various stages of filling the first container with solvent. Figure 5: a schematic view of a container arrangement in a third embodiment. Figure 6: a view of the container arrangement according to Figure 5 with the first container full.

[0035] An inner, small, flexible bag containing the concentrate is enclosed by another bag, larger than the inner, flexible bag, which merely serves as an outer shell for stabilization. This shell can also serve as secondary packaging.

[0036] In this case, only an additional, smaller protective package may be necessary at the connector. To produce the ready-to-use solution, the flexible bag, i.e., the first container, expands into the larger outer bag, i.e., the second container. Preferably, there should be no air between the inner and outer bags, i.e., between the first and second containers. Removing the air is preferable to prevent the trapped air from creating an insulating effect during hot steam sterilization.

[0037] Figure 1 shows with the reference number 10 the first container in the form of the inner bag and with the reference number 20 the second container, which is also designed as a bag and represents the outer bag that surrounds the inner bag.

[0038] According to Figure 1The inner bag 10 and the outer bag 20 are welded together at the top and bottom ends. The expansion of the inner bag is controlled in both sides of the outer bag until it is completely filled, as can be seen from Figure 2 which shows the filling at different times.

[0039] The inner bag 10 is provided with a connector 30, by means of which solvent or water can be filled into the inner bag 10 and the ready-to-use solution can be drained from the inner bag 10.

[0040] In the illustrated embodiment, the first container 10, i.e., the inner bag, has a volume of 200 ml and extends over the entire height of the second bag, which constitutes the outer packaging. This height is 300 mm in the illustrated embodiment. The width of the first bag 10 is 60 mm, and the width of the second bag 20 is 200 mm.

[0041] All of the above dimensions are not restrictive, but only exemplary and refer to the container arrangement before filling the first bag 10 with solvent, ie in the non-expanded state.

[0042] By filling with solvent, which is preferably pure water, a bag arrangement is obtained which holds a volume of 2 l of ready-to-use solution.

[0043] In another variant according to Figure 3 The inner bag 10 containing the liquid concentrate is connected to the outer bag 20 only at its top side (tube weld). This means that the inner bag 10 must be pre-welded in an upstream process step; however, welding to the outer bag 20 can be omitted, which has advantages in terms of production technology.

[0044] In the illustrated embodiment according to Figure 3The first container 10, ie the inner bag, has a volume of 200 ml and does not extend over the entire height of the second bag, which represents the outer packaging. The height of the first container 10 is in the embodiment according to Figure 3 The width of the first bag 10 is 200 mm and the width of the second bag 20 is 300 mm.

[0045] Also for this embodiment, all of the above dimensions are not restrictive, but only exemplary and refer to the container arrangement before the first bag 10 is filled with solvent, ie in the non-expanded state.

[0046] By filling with solvent, which is preferably formed by pure water, a bag arrangement is obtained which holds a volume of 2 l of ready-to-use solution.

[0047] How this Figure 4As can be seen, the first bag 10 expands to both sides and downwards towards the second bag 20 when it is filled with pure water.

[0048] In principle, the dimensions of both bags and variants can be designed in such a way that different final volumes can be achieved.

[0049] The dimensions and ratios of the two bags depend on the final volume and flexibility of the inner bag or the first container.

[0050] In a preferred embodiment, the initial volume is 0.1 litres - 6.5 litres, preferably 0.2 litres - 2 litres, particularly preferably 0.3 litres - 1 litre, and the final volume is 1 litre - 65 litres, preferably 1.5 litres - 12 litres, particularly preferably 2 litres - 5 litres.

[0051] The empty protruding parts of the outer bag, i.e., the second container, can be folded and rolled around the bag for transport and storage. It is preferably ensured that easy unfolding during filling occurs through expansion of the inner bag.

[0052] The key idea behind the flexible inner bag 10, which is transported protected within an outer bag 20 and can later expand into it during filling, is to separate the flexibility required for its function from the outer packaging / support effect. This allows for a more cost-effective selection of materials. The flexible inner bag, with its high proportion of expensive materials, is significantly smaller in area and thus consumes significantly less energy than the larger outer bag made with less demanding and cheaper materials.

[0053] In a preferred embodiment, the advantages of the present invention are: significantly less outer packaging or less outer packaging by integrating a support function and protective function into one film, thus less waste and cost savings.

[0054] Reduced storage and transport volume and lower weight. This allows for better filling of tertiary packaging and requires less tertiary packaging, i.e., less carton per solution bag.

[0055] Only a smaller solution bag 10 is required. This results in a smaller surface-to-volume ratio, which promotes low water loss and has the advantage that the filled solution bag can be overfilled because no or only shorter transport requirements need to be met, or because appropriate rigid support structures protect the bag.

[0056] In the embodiment from Fig. 5The invention is applied to a peritoneal dialysis system with a drainage bag 9 as the first container. The drainage bag 9 is accommodated in a second container 10, which surrounds the drainage bag 9 in a mesh-like manner. Drainage fluid / used dialysis fluid can flow from a patient connector 2 into the drainage bag 9 via a line 4, a connecting connector 5, and a connecting tube 6 after removal of the cap 1 and connection to the patient.

[0057] Fresh dialysis fluid can be supplied to the patient from a container 8 via a line 3.

[0058] As in Fig. 6 As shown, the drainage bag 9 expands within the second container 10 when fluid, in particular used dialysis fluid, is introduced into the drainage bag 9.

Claims

1. Container arrangement having a first container (10), wherein the first container (10) is either a container in which a concentrate is located that is configured to form a ready-to-use dialysis solution or a component thereof on a dilution with a solvent, preferably with pure water (water for injection), or an empty container suitable as a drainage bag for dialysis, characterized in that the container arrangement has a second container (20) in which the first container (10) is received, with the first container (10) having a greater elasticity than the second container (20) and with the first container (10) being configured to expand up to the second container (20).

2. Container arrangement in accordance with claim 1, characterized in that the second container (20) is flexible, but not elastic; and / or in that the first bag (10) is flexible and elastic.

3. Container arrangement in accordance with claim 1 or claim 2, characterized in that there is a vacuum (10, 20) between the first and second containers.

4. Container arrangement in accordance with one of the preceding claims, characterized in that the second container (20) represents a boundary by volume on the expansion of the first container (10) and gives the container arrangement structural strength.

5. Container arrangement in accordance with one of the preceding claims, characterized in that the first and / or second containers (10, 20) is / are a bag / bags.

6. Container arrangement in accordance with one of the preceding claims, characterized in that the first and second containers (10, 20) are directly or indirectly connected to one another at one or more points.

7. Container arrangement in accordance with claim 6, characterized in that the connection takes place by welding.

8. Container arrangement in accordance with one of the preceding claims, characterized in that the first and second containers (10, 20) have an upper end and a lower end; and in that the containers are connected, in particular welded, to one another at these two ends or at one of these ends.

9. Container arrangement in accordance with one of the preceding claims, characterized in that the first container (10) is provided with a connector (5) that leads from the interior of the first container to the exterior.

10. Container arrangement in accordance with one of the preceding claims, characterized in that the second container (20) represents the outer packaging of the first container (10).

11. Container arrangement in accordance with one of the preceding claims, characterized in that first container (10) is a container in which a concentrate is located that is configured to form a ready-to-use dialysis solution or a component thereof on a dilution with a solvent, preferably with pure water (water for injection), and the concentrate is present in liquid form.

12. Container arrangement in accordance with one of the preceding claims, characterized in that the second container (20) is partly or fully folded or rolled around the first container (10).

13. Container arrangement in accordance with one of the preceding claims, characterized in that the first container (10) is a drainage bag of a peritoneal dialysis system.

14. Container arrangement in accordance with claim 13, characterized in that the second container (20) has a perforated and / or net-like structure.

15. Method of filling a container arrangement in accordance with one of the claims 1 to 14 with liquid or solvent, in particular with pure water (water for injection), wherein the liquid or solvent is filled into the first container that expands in this process.

16. Method in accordance with claim 15, characterized in that the filling is carried out such that the first container (10) expands up to the second container (20) that represents a structural boundary of the expansion of the first container (10).