Multi-chamber pouch for producing dialysate

Abstract

The invention relates to a multi-chamber pouch for producing a medical solution, in particular a dialysate, comprising at least two chambers which are connected to one another via a peeling seam and which are defined by respective sealing seams located at a first side and at a second side opposite the first side, the multi-chamber bag further comprises a third side part formed by the folded film, and at least one connecting part is formed on the third side part by means of butt welding.

Description

Technical Field

[0001] The invention relates to a multi-chamber bag for producing a dialysate and a method for producing such a multi-chamber bag. Background Art

[0002] During dialysis, bags containing pre-made dialysis fluid or at least some of its components are often used. For example, for reasons of storage stability, it may be advantageous to store some of the components of the solution (e.g., dialysis fluid) separately and only mix them immediately before use.

[0003] For this purpose, multi-chamber bags are often used, which contain the individual subcomponents in separate chambers, which are mixed together immediately before the solution is used.

[0004] For example, such a multi-chamber bag can have two different solutions, a solution and a dry concentrate, a solution and a paste concentrate or any other content. Examples include solutions for peritoneal dialysis or hemofiltration and preparations for parenteral nutrition.

[0005] EP 0 935 967 discloses a solution for peritoneal dialysis consisting of two separate solutions provided in a dual-chamber bag. The first separate solution contains calcium ions, other electrolyte salts, and glucose in an osmotic concentration. The second separate solution contains bicarbonate and a salt of a weak acid with a pKa < 5. Prior to use, the two chambers must be mixed to obtain a ready-to-use peritoneal dialysis solution.

[0006] WO 2003 / 059417 discloses a two-part dialysis solution comprising a first component comprising a bicarbonate concentrate and a second component comprising an electrolyte concentrate, the dialysis solution being provided in a dual compartment bag and mixed immediately before use.

[0007] Conventional multi-chamber bags each have a connection or filling port for filling the corresponding chamber, by means of which each chamber can be filled. The connectors, filling nozzles and sealing caps required for this purpose complicate the production and application of such multi-chamber bags. Summary of the Invention

[0008] Against this background, the object of the present invention is to alleviate or even completely eliminate the problems of the prior art. In particular, the object of the present invention is to create a simplified and more cost-effective multi-chamber bag and a related manufacturing method.

[0009] This object is achieved by a multi-chamber bag having the features of claim 1 and a method having the features of claim 9 .

[0010] Further advantageous modifications of the invention are the subject matter of the dependent claims.

[0011] Accordingly, a multi-chamber bag for producing medical solutions, in particular dialysate, is provided, the multi-chamber bag comprising at least two chambers connected to one another by a peel seam and bounded by sealed seams on a first side and a second, opposite side of the bag, respectively. The multi-chamber bag further comprises a third side formed from a folded film, on which at least one connection is arranged by means of a butt weld.

[0012] Attaching the connection part to the third side part preferably has the advantage that the connection part is located on the outermost layer of the folded film rather than being integrated into the folded film or its layer structure or sandwiched between two films.

[0013] Preferably, the term "butt welding" refers to a method of butt welding two end faces together in a manner that they are in contact with each other. Butt welding is also called mirror welding.

[0014] For example, the connection portion may comprise a tubular section. First, the tubular section is widened at one end (preferably in a tulip shape) to form a larger end face, similar to a flange. The end face of the tubular section is then placed on a surface (e.g., a membrane) and welded to the surface.

[0015] In this process, the end face of the tubular section lies on the surface of the membrane but is not integrated into the membrane, for example in the case of a multilayer membrane it is not arranged between layers of the membrane or sandwiched between two membranes.

[0016] Butt welding can be used to create particularly strong and resilient joints.

[0017] A plurality of connections can be arranged on the third side, wherein at least one connection, preferably all connections, are arranged on the membrane by means of butt welding.

[0018] According to one embodiment, the multi-chamber bag comprises a sealing seam on a fourth side opposite the third side, preferably with a hanging eyelet or a plurality of hanging eyelets. The width of the sealing seam is preferably such that the hanging eyelet is completely surrounded by the sealing seam.

[0019] Preferably, the multi-chamber bag or at least one chamber of the multi-chamber bag does not have a filling port for filling at least one chamber of the multi-chamber bag, preferably in the form of a connection, a port or a connector.

[0020] Such a filling port is preferably understood to be an access to the receiving area of ​​the bag, which is designed to enable filling of the receiving area of ​​the bag before the bag or bag system is delivered to the end user or before the bag is used for peritoneal dialysis. After filling, the filling port is usually permanently closed, for example with a sealing cap.

[0021] Such a filling port is preferably not required, since the multi-chamber bag according to the invention is preferably filled using the method according to the invention before the bag is closed.

[0022] It is therefore not necessary to convey the liquid into the chamber of the bag, for example via a port, but rather the chamber is closed and formed only after filling.

[0023] It is conceivable that the multi-chamber bag thus has only one connection for removing the contents from the bag, wherein preferably at least one chamber of the multi-chamber bag does not have its own connection, port or connector. The contents of a chamber can preferably only reach the outside via a connection of another chamber of the multi-chamber bag, for example after opening a peel seam that separates the chambers.

[0024] According to one embodiment, the multi-chamber bag comprises a first chamber and a second chamber, wherein the first chamber is limited by a third side having the connecting portion, and the second chamber can be connected to the first chamber by opening the peel seam, so that the content of the second chamber can only be transferred to the outside via the first chamber and the connecting portion located on the third side of the bag.

[0025] Preferably, the second chamber is limited only by the peel seam, the sealing seams on the first and second side portions, and the sealing seam on the fourth side portion.

[0026] Preferably, the longitudinal axis of the peel seam extends at right angles or substantially at right angles to the longitudinal axis of the multi-chamber bag.This makes it easy to form two chambers of different sizes.

[0027] Alternatively, the peel seam can also extend parallel to the longitudinal axis of the multi-chamber bag.

[0028] According to one embodiment, at least two chambers of the bag each have contents designed to produce a ready-to-use dialysate when said contents are combined with the contents of another chamber of the multi-chamber bag.

[0029] For example, at least one chamber may contain an acidic concentrate, while another chamber may contain an ionic solution.At least one chamber may contain bicarbonate and / or an osmotic agent, such as a sugar.

[0030] The present invention also relates to a method for producing a multi-chamber bag, preferably a multi-chamber bag according to the present invention, comprising the following steps:

[0031] a) providing a flat film having two outer edges, wherein the flat film can be a multilayer film or a single layer film;

[0032] b) fixing at least one connection to the flat membrane by means of butt welding and preferably producing an opening in the flat membrane in the region of the connection, for example by punching or using a hot mandrel;

[0033] c) producing a film tube from the flat film, preferably by means of forming a shoulder over which the flat film extends and by sealing the outer edges of the flat film together;

[0034] d) producing a peel seam between the two layers of the flat film of the film tube, said peel seam detachably joining the two layers of the flat film to one another, said peel seam extending in the longitudinal direction of the film tube between the two outer edges of the film tube, thereby producing at least two receiving areas which are separated from one another by means of the peel seam;

[0035] e) producing a sealing seam extending perpendicularly or substantially perpendicularly to the peel seam, thereby creating a receiving pocket in each of the two receiving areas;

[0036] f) filling the two receiving bags along the longitudinal direction of the film tube, preferably with two different contents; and

[0037] g) Closing the two receiving pockets by creating an additional sealing seam extending perpendicularly or substantially perpendicularly to the peel seam, thereby closing the receiving pockets and forming at least two completely closed chambers.

[0038] The following parameters are preferably used for the butt welding in step b):

[0039]

[0040] The following parameters are particularly preferred:

[0041]

[0042] Welding pressure: 3000N where A=6300mm 2 →0.48N / mm 2

[0043] Preferably, multi-chamber bags are produced continuously along a continuous film tube, which are respectively connected to one another via sealing seams and which are separated from one another by separation along sealing seams extending perpendicularly or substantially perpendicularly to the peel seams.

[0044] In other words, preferably a continuous film tube is produced which is filled in the longitudinal direction of the tube and is divided into different bags by being sealed in the transverse direction.

[0045] This means that when the tube is filled, preferably two parallel columns of filling material are produced which are separated by the peel seam and which are divided into a plurality of multi-chamber bags by transverse seals.

[0046] According to one embodiment, in step f), the at least two receiving bags are filled with a liquid, solid and / or pasty content, preferably designed for producing a dialysate, by means of two separate filling guns.

[0047] Preferably, the multi-chamber bag according to the invention and its butt-welded connections are made of polymer material and are designed as a disposable or throwaway product.

[0048] Preferably, the method according to the invention is performed by a single machine.

[0049] It should be pointed out here that the present disclosure is not limited to the explicitly disclosed feature combinations, and the features disclosed herein may also be claimed in other combinations or individually.

[0050] Further advantages, effects and features of the present invention are shown in the following description of preferred embodiments with reference to the accompanying drawings, in which like reference numerals denote like or similar components. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] In the attached figure:

[0052] Figure 1 A multi-chamber bag according to the present invention is shown, and

[0053] Figure 2 The continuous production of a multi-chamber bag according to the invention from a continuous film tube is shown. DETAILED DESCRIPTION

[0054] Figure 1 A multi-chamber bag 1 according to the invention is shown having two chambers A and B which are connected to one another by a peel seam 2 and which are limited on a first side and a second opposing side 3 and 4 respectively by respective sealing seams.

[0055] The multi-chamber bag 1 further comprises a third side portion 5 formed from a folded film, on which two connections in the form of tubular sections 6 are arranged by means of butt welding.

[0056] The bag 1 is made from a flat film by folding the film on a third side 5 and sealing the outer edges of the flat film together on a fourth side to form a sealing seam 7, thereby first forming a film tube. At least one hanging eyelet 8 is located in the sealing seam 7 opposite the connection 6.

[0057] Then at the lower end of the bag 1 (second side 4) a Figure 1 The transverse sealed seams shown in .

[0058] In this intermediate state, if Figure 1 As shown, the upper sides of chambers A and B remain open, thereby forming a chamber that can be viewed from above (at Figure 1 (View shown) Conveniently filled receiving bag.

[0059] After filling the receiving bag, a convex shape is produced at the upper end (first side 3) of the bag 1. Figure 1 Transverse sealing seams are shown, thereby closing the receiving bag and forming chambers A and B.

[0060] Chamber B does not have its own connection or port, so that the contents of chamber B can only reach the outside via the opened peel seam 2, chamber A and its connection.

[0061] Figure 2 The continuous production of a multi-chamber bag 1 according to the invention from a continuous film tube 9 is shown.

[0062] like Figure 2 As shown, the film tube 9 preferably extends in the vertical direction during filling. Figure 2 In the view shown, the film tube 9 comprises four multi-chamber bags 1 which are not yet separated from one another in this view, but are connected to one another via a common transverse sealing seam on the side parts 3 , 4 .

[0063] A common transverse sealing seam on the side portions 3, 4 separates the chambers A and B of adjacent multi-chamber bags 1. Each bag 1 is provided with a connection 6 which is butt-welded.

[0064] Figure 2 The top bag shown in FIG shows the filling of chambers A and B. In this bag, as shown in FIG. Figure 2 As shown, the upper ends of chambers A and B are not yet closed, thus forming receiving pockets TA and TB for filling material.

[0065] Each receiving bag TA, TB is filled with specific contents, preferably vertically from above, by means of a separate filling device, such as a filling gun 10, 11. Once the receiving bags TA and TB are sufficiently filled, they are closed by transverse sealing.

[0066] This type of filling eliminates the need to equip each chamber A and B of the multi-chamber bag with a separate filling connection or port.

[0067] In order to separate the individual bags 1 of the continuous film tube 9 from one another, they are cut apart in the transverse direction along the common transverse sealing seam on the side portions 3 , 4 .

Claims

1. A multi-chamber bag for producing medical solutions, in particular dialysate, comprising at least two chambers connected to one another via a peel seam and defined by respective sealing seams at a first side and a second side opposite the first side, characterized in that The multi-chamber bag further comprises a third side portion formed by a folded film, on which at least one connection is formed by means of butt welding.

2. The multi-chamber bag according to claim 1, wherein: The multi-chamber bag comprises a sealed seam on a fourth side opposite the third side, preferably with hanging eyelets.

3. The multi-chamber bag according to claim 1 or 2, characterized in that The multi-chamber bag is free of a filling port for filling at least one chamber of the multi-chamber bag, preferably in the form of a connection, port or connector.

4. The multi-chamber bag according to any one of the preceding claims, characterized in that The multi-chamber bag comprises a first chamber and a second chamber, wherein the first chamber is at least partially limited by a third side portion having the connecting portion, and the second chamber can be connected to the first chamber by opening the peel seam, so that the content of the second chamber can only be transferred to the outside via the first chamber and the connecting portion located on the third side portion.

5. The multi-chamber bag according to claim 4, wherein: The second chamber is limited only by the peel seam, the sealing seams on the first and second side portions, and the sealing seam on the fourth side portion.

6. The multi-chamber bag according to any one of the preceding claims, characterized in that The longitudinal axis of the peel seam extends at right angles or substantially at right angles to the longitudinal axis of the multi-chamber bag.

7. The multi-chamber bag according to any one of the preceding claims, characterized in that At least two chambers of the bag each have contents designed to produce a ready-to-use dialysate when the contents are combined with the contents of another chamber of the multi-chamber bag.

8. The multi-chamber bag according to any one of the preceding claims, characterized in that The connecting portion is welded to the third side portion in such a way that it is located on the outermost layer of the folded film, rather than being arranged between two films or integrated into the folded film or its layer structure.

9. A method for producing a multi-chamber bag, preferably a multi-chamber bag according to any one of claims 1 to 8, comprising the following steps: a) providing a flat membrane having two outer edges; b) fixing at least one connection portion to the flat membrane by means of butt welding; c) producing a film tube from the flat film by sealing the outer edges of the flat film together; d) producing a peel seam extending in the longitudinal direction of the film tube between the two outer edges of the film tube, thereby producing at least two receiving areas separated from one another by means of the peel seam; e) producing a sealing seam extending perpendicularly or substantially perpendicularly to the peel seam, thereby creating a receiving pocket in each of the two receiving areas; f) filling two receiving bags along the longitudinal direction of the film tube, preferably with two different contents; as well as g) Closing the two receiving pockets by creating an additional sealing seam extending perpendicularly or substantially perpendicularly to the peel seam, thereby closing the receiving pockets and forming at least two completely closed chambers.

10. The method according to claim 9, characterized in that Multi-chamber bags are produced continuously along a continuous film tube, which are each connected to one another via a sealing seam and are separated from one another by separation along a sealing seam extending perpendicularly or substantially perpendicularly to the peel seam.

11. The method according to claim 8 or 9, characterized in that In step f), the two receiving bags are filled with a liquid, solid and / or pasty content designed for producing a dialysate by means of two separate filling guns.

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