Container device and method for filling a container device

Abstract

The invention relates to a container arrangement having a first container, wherein the first container is a container in which a concentrate is present or is an empty container, the concentrate being designed to form a ready-to-use dialysis solution or its components when diluted with a solvent, preferably pure water (water for infusion), wherein the container arrangement has a second container in which the first container is accommodated, wherein the first container has a greater elasticity than the second container and wherein the first container is designed to expand toward the expansion of the second container.

Description

Technical Field

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

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

[0003] It is known from the prior art to use sterile solutions for the dialysis treatment of patients, which contain water as solvent, some physiological salts, buffers and glucose. The main component of the solution is water, which accounts for the majority of the solution by volume and weight. Thus, large amounts of highly pure water are moved during the preparation process, storage and transportation. This not only has handling and transportation disadvantages, but is also associated with the disadvantage that transportation and storage bring about energetic disadvantages. Summary of the invention

[0004] The invention is based on the object of realizing a container device for preparing a dialysis solution that is easy to handle and reduces the amount of water moved during the process for preparing the dialysis solution. In addition, another object of the invention is to provide an improved drainage bag for peritoneal dialysis.

[0005] This object is achieved by a container device having the features of an embodiment.

[0006] It is proposed that the container device has a second container, in which the first container is accommodated, wherein the first container has a greater elasticity than the second container, and wherein the first container is designed to expand toward the second container. The invention is therefore based on the following basic idea, that the first container is arranged in the second container, wherein the first container is elastically designed so that the first container can expand toward the second container when filled with a solvent, in particular pure water (water for infusion) or another liquid. Pure water is suitable for medical solutions, in particular for injection into a patient. Therefore, pure water is usually sterile.

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

[0008] The invention makes it possible to reduce the water content and to provide a preferably liquid concentrate which is preferably packaged in an appropriate manner (stable, autoclavable, etc.) Preferably, the concentrate can be replenished with a ready-to-use solution via a dedicated port near or at the patient simply by filling with pure water.

[0009] Preferably, the second container is not in contact with the liquid, and in this case does not need to meet any special properties in terms of containing the liquid.

[0010] It is thereby possible to divide or distribute the tasks (liquid storage and structural strength) between the two containers, whose materials can then be selected accordingly.

[0011] For example, it is conceivable that the second container is flexibly but not elastically configured. "Not elastic" is also understood to mean that there is very little elasticity. This elasticity is preferably so small that the second container limits the expansion of the first container when the first container is filled with solvent.

[0012] The first bag is preferably flexible and elastic. Here, the film of the first bag preferably has an elongation at break of 400-900% in the longitudinal and transverse directions.

[0013] In order to prevent insulating effects caused by air cushions during heat sterilization of the container arrangement, it is preferably provided that a vacuum exists between the first and second container. When the first container is filled, it expands into this evacuated area, preferably until it rests against the second container. During production, the air between the two bags can be removed very easily by welding / sealing in a vacuum.

[0014] It is therefore preferably provided that the second container is a limitation in terms of volume when the first container is expanded and provides structural strength to the container arrangement.

[0015] A particularly preferred embodiment results when the first and / or 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. By indirectly connected is understood that the first and second containers are fixed to a part of the container device, for example to a connector for filling and emptying the first container, but are not directly connected to each other.

[0017] Preference is given to a direct connection of the two containers at one or more locations or sides, for example by means of welding.

[0018] The preferred connection of the containers is therefore achieved by welding the containers.

[0019] It is conceivable that the first and second containers have an upper end and a lower end respectively, and the containers are connected to each other at these two ends or at one of these ends, especially welded. Other variants are also contemplated, such as welding the bag only on one side, ie on the right or left side.

[0020] Furthermore, it can be provided that the first container is provided with a connector leading outward from the interior of the first container. The connector or a hose with the connector is used to fill the first container with solvent or to empty the ready-to-use dialysis solution or part of the dialysis solution from the expanded first container.

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

[0022] The second container can be an outer packaging of the first container. The function of the outer packaging is to construct a water vapor barrier. Therefore, the film of the second container preferably has a water vapor barrier of 0.2-5.0 g / (m 2* d) permeability.

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

[0024] Furthermore, it is conceivable that the second container is partially or completely folded or rolled up around the first container, so that a space-saving container arrangement is produced, in particular during storage and transport.

[0025] The invention relates to a method for filling a container arrangement according to an embodiment with a solvent, in particular pure water, wherein the solvent is filled into a first container which is expanded here. Instead of the solvent, any other liquid can also be used.

[0026] Preferably, filling is performed in such a way that the first container expands as far as the second container, which is a structural limit to the expansion of the first container.

[0027] The invention furthermore relates to the use of a solution produced by the process according to the invention as a ready-to-use dialysis solution, in particular a peritoneal dialysis solution, or a component thereof.

[0028] By means of a 10-fold (or higher) concentrated solution, sufficient miscibility of the contents of a common dialysis solution (glucose, salts, buffer) at the required concentrations can be achieved. Accordingly, the concentrate in the first container is preferably concentrated 10-fold or higher.

[0029] The concentrate preferably contains at least one osmotic substance and / or one or more electrolytes and / or one or more buffers and particularly preferably contains all the components required for the preparation of the dialysis solution, apart from the water required in total.

[0030] Furthermore, it has proven to be advantageous in practice if the first container is a drainage bag of a peritoneal dialysis system.

[0031] Preferably, in such an application, the second container has a perforated and / or mesh-like structure, which forms a reliable support structure for the first container with preferably minimal material consumption. The second container can be made, for example, as a mesh bag and / or made of wire, strips or ropes. The use of such a second container makes it possible for the first container / drainage bag to be made particularly thin-walled and / or made of a particularly elastic material, since the second container supports and protects the first container.

[0032] In this regard, it should be noted that the terms "a" and "an" do not necessarily refer to exactly one of the elements described, although this is a possible embodiment, but can also refer to multiple elements. Likewise, the use of the plural number also includes the existence of the discussed element in the singular, and vice versa, the singular also includes a plurality of the discussed elements.

[0033] In other words, the present invention can also be described as follows:

[0034] Aspect 1 of the invention relates to a container arrangement having a first container in which a concentrate is present, which is designed to form a ready-to-use dialysis solution or its components when diluted with a solvent, preferably with pure water (water for infusion), characterized in that the container arrangement has a second container in which the first container is accommodated, wherein the first container has a greater elasticity than the second container and wherein the first container is designed to expand toward the second container.

[0035] Aspect 2 of the present invention relates to the container device according to aspect 1, characterized in that the second container is flexibly but not elastically constructed, and / or the first bag is flexible and elastic.

[0036] Aspect 3 of the present invention relates to the container device according to aspect 1 or 2, wherein a vacuum exists between the first container and the second container.

[0037] Aspect 4 of the present invention relates to a container device according to one of the above aspects, characterized in that the second container is a volume restriction when the first container expands and provides structural strength to the container device.

[0038] Aspect 5 of the present invention relates to a container device according to one of the above aspects, characterized in that the first and / or second container is a bag.

[0039] Aspect 6 of the present invention relates to a container device according to one of the above aspects, characterized in that the first and second containers are directly or indirectly connected to each other at one or more locations.

[0040] Aspect 7 relates to the container device according to aspect 6, characterized in that the connection is achieved by welding.

[0041] Aspect 8 of the invention relates to a container arrangement according to one of the above aspects, characterized in that the first and second containers have an upper end and a lower end, and the containers are connected to each other at these two ends or at one of these ends, in particular welded.

[0042] Aspect 9 of the present invention relates to the container device according to one of the above aspects, characterized in that the first container is provided with a connector leading from the inside toward the outside of the first container.

[0043] Aspect 10 of the present invention relates to a container device according to one of the above aspects, characterized in that the second container is an outer packaging of the first container.

[0044] Aspect 11 of the present invention relates to a container device according to one of the above aspects, characterized in that the concentrate is in liquid form.

[0045] Aspect 12 of the present invention relates to a container device according to one of the above aspects, characterized in that the second container is partially or completely folded or rolled around the first container.

[0046] Aspect 13 of the present invention relates to a method for filling a container device according to one of aspects 1 to 12 with a solvent, in particular pure water (water for infusion), wherein the solvent is filled into a first container which is expanded therein.

[0047] Aspect 14 relates to the method according to aspect 13, characterized in that the filling is performed such that the first container expands towards the second container, the second container being a structural limit to the expansion of the first container.

[0048] Aspect 15 relates to the use of a solution prepared according to the method according to aspect 13 or 14 as a ready-to-use dialysis solution, in particular as a peritoneal dialysis solution or a component thereof. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] Further details and advantages of the invention are explained in greater detail with reference to the exemplary embodiments shown in the drawings.

[0050] The accompanying drawings show:

[0051] Figure 1 A schematic diagram showing a container device in a first embodiment,

[0052] Figure 2 The following diagram shows the different stages of filling the first container with solvent according to Figure 1 A view of a container device,

[0053] Figure 3A schematic diagram showing a container device in a second embodiment.

[0054] Figure 4 The following diagram shows the different stages of filling the first container with solvent according to Figure 3 A view of a container device,

[0055] Figure 5 A schematic diagram showing a container device in a third embodiment,

[0056] Figure 6 Shown when the first container is filled according to Figure 5 View of the container device. DETAILED DESCRIPTION

[0057] The inner, small and flexible bag containing the concentrate is surrounded by another bag, which is larger than the inner flexible bag and is only an outer sheath for stability. This sheath can also be a secondary packaging at the same time.

[0058] In this case, only a further smaller protective packaging would still be needed at the connector. To prepare a ready-to-use solution, the flexible bag, i.e., the first container, is expanded into a larger outer bag, i.e., the second container. In this case, preferably no air is present between the inner bag and the outer bag, i.e., between the first container and the second container. The air is preferably removed so that no insulating effect of trapped air occurs during hot steam sterilization.

[0059] exist Figure 1 In the drawing, reference numeral 10 denotes a first container in the form of an inner bag, and reference numeral 20 denotes a second container which is also designed as a bag and is an outer bag surrounding the inner bag.

[0060] according to Figure 1 The inner bag 10 and the outer bag 20 are welded to each other at the upper and lower ends. The bag expansion of the inner bag in this case takes place in a controlled manner on both sides of the outer bag until it is completely filled, such as from Figure 2 As seen in Figure 2 Population at different time points is shown.

[0061] The inner bag 10 is provided with a connector 30 , by means of which the inner edge bag 10 can be filled with solvent or water and the ready-to-use solution can be discharged from the inner bag 10 .

[0062] In the embodiment shown, 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 as the outer packaging. In the embodiment described, this height is 300 mm. The width of the first bag 10 is 60 mm, while the width of the second bag 20 is 200 mm.

[0063] All the above measurements are non-limiting but merely exemplary and relate to the container device before filling the first bag 10 with solvent, ie in a non-expanded state.

[0064] By filling with a solvent, preferably formed by pure water, a bag device is obtained which contains a volume of 2 liters of ready-to-use solution.

[0065] In accordance with Figure 3 In another variant, the inner bag 10 containing the liquid concentrate is connected to the outer bag 20 only at its upper side (hose welding). Although the inner bag 10 must be pre-welded in an upstream processing step, welding to the outer bag 20 can be omitted, which has advantages in terms of production technology.

[0066] Based on the shown Figure 3 In the embodiment of the invention, the first container 10, i.e. the inner bag, has a volume of 200 ml and does not extend over the entire height of the second bag as the outer packaging. Figure 3 In the embodiment of the present invention, the height of the first container 10 is 200 mm, and the height of the second container 20 is 300 mm. The width of the first bag 10 is 100 mm, and the width of the second bag 20 is 200 mm.

[0067] It also applies to this embodiment that all the above-mentioned measurements are not limiting but merely exemplary and relate to the container device before the first bag 10 is filled with solvent, ie in the non-expanded state.

[0068] By filling with a solvent, preferably formed from pure water, a bag device is obtained which contains a ready-to-use solution in a volume of 2 liters.

[0069] from Figure 4 It can be seen in FIG. 1 that when the first bag 10 is filled with pure water, the first bag 10 expands toward the sides and downward toward the second bag 20 .

[0070] In principle, the two bags and variants can be dimensioned in such a way that different final volumes can be achieved.

[0071] The deviation and ratio of the measurements of the two bags depends on the final volume and flexibility of the inner bag or first container.

[0072] In a preferred embodiment, the initial volume is 0.1 to 6.5 liters, preferably 0.2 to 2 liters, particularly preferably 0.3 to 1 liter, and the final volume is 1 to 65 liters, preferably 1.5 to 12 liters, particularly preferably 2 to 5 liters.

[0073] The outer bag, i.e. the empty protruding part of the second container, can be folded and rolled up around the bag for transportation and storage. It is preferably ensured that simple unfolding is carried out by the expansion of the inner bag during filling.

[0074] The main idea of ​​the flexible inner bag 10, which is transported in an outer bag 20 in a protected manner and can then expand into the outer bag when filled, is to separate the flexibility necessary for the function from the outer packaging / support function. This allows for a more cost-effective material selection. The flexible inner bag with a higher proportion of expensive material is significantly smaller in terms of area than a larger outer bag with less demanding and cheaper material and thus has significantly lower consumption.

[0075] In a preferred embodiment, the advantages of the present invention are listed as follows:

[0076] Outer packaging that is smaller or significantly smaller due to the integration of the supporting and protective functions in the film, resulting in less waste and cost savings.

[0077] Less storage and transport volume and less weight. This allows for better filling of the tertiary packaging and requires smaller tertiary packaging, i.e. cartons per solution bag.

[0078] Only smaller solution bags 10 are needed. This results in a smaller surface / volume ratio, which is favorable for low water losses and has the advantage that the filled solution bag can be overfilled, since no or only short transport requirements or correspondingly rigid support structures are required to protect the bag.

[0079] exist Figure 5 In the embodiment of the invention, the invention is applied to a peritoneal dialysis system having a drainage bag 9 as a first container. The drainage bag 9 is accommodated in a second container 10, which surrounds the drainage bag 9 in a meshed manner / in the form of a mesh bag. After removing the cover 1 and connecting to the patient, the drainage liquid / used dialysis liquid flows from the patient connector 2 into the drainage bag 9 via the line 4, the connecting connector 5 and the connecting hose 6.

[0080] Fresh dialysis fluid can be supplied to the patient from the container 8 via the line 3 .

[0081] As in Figure 6 As shown in FIG. 1 , when fluid, in particular used dialysis fluid, is introduced into the drain bag 9 , the drain bag 9 expands in the second container 10 .

Claims

1. A container device having a first container, wherein: The first container is a container in which a concentrate is present, which is designed to form a ready-to-use dialysis solution or a component thereof when diluted with a solvent, characterized in that the container device has a second container, in which the first container is accommodated, wherein the first container has a greater elasticity than the second container, and wherein the first container is designed to expand toward the second container, wherein the second container is flexibly but not elastically designed, wherein the first container is flexible and elastic, and wherein the second container is an outer packaging of the first container.

2. The container device according to claim 1, characterized in that A vacuum exists between the first container and the second container.

3. The container device according to claim 1 or 2, characterized in that: The second container is a volume limiter when the first container is expanded and provides structural strength to the container device.

4. The container device according to claim 1 or 2, characterized in that: The first container and / or the second container is a bag.

5. The container device according to claim 1 or 2, characterized in that: The first container and the second container are directly or indirectly connected to each other at one or more locations.

6. The container device according to claim 5, characterized in that The connection is performed by welding.

7. The container device according to claim 1 or 2, characterized in that: The first container and the second container have an upper end and a lower end, and the containers are connected to each other at the two ends or at one of the two ends.

8. The container device according to claim 1 or 2, characterized in that: The first container is provided with a connector leading from the interior toward the exterior of the first container.

9. The container device according to claim 1 or 2, characterized in that: The concentrate is in liquid form.

10. The container device according to claim 1 or 2, characterized in that: The second container is partially or completely folded or rolled around the first container.

11. The container device according to claim 1, characterized in that The solvent is pure water.

12. The container device according to claim 1, characterized in that The solvent is water for infusion.

13. The container device according to claim 1 or 2, characterized in that: The first container and the second container have an upper end and a lower end, and the containers are welded to each other at the two ends or at one of the two ends.

14. A method for filling a container device according to any one of claims 1 to 13 with a liquid or a solvent, wherein: The liquid or the solvent is filled into the first container, which expands in the process.

15. The method according to claim 14, characterized in that The filling is performed such that the first container expands towards the second container, the second container being a structural limit to the expansion of the first container.

16. The method according to claim 14, characterized in that The liquid or solvent is pure water.

17. The method according to claim 14, characterized in that The liquid or solvent is water for infusion.

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