Bag system for peritoneal dialysis

Abstract

The invention relates to a bag system for peritoneal dialysis, comprising a solution bag and a drainage bag, which are fluidically connected to each other, preferably via a three-way valve, each comprising a side formed from a folded membrane, which side forms at least one connection by butt welding. The invention also relates to a method for manufacturing such a bag system.

Description

Technical Field

[0001] The present invention relates to a bag system for peritoneal dialysis and a method for producing such a bag system. Background Art

[0002] A bag system for peritoneal dialysis is known in the prior art and comprises a solution bag filled with fresh dialysate and a drainage bag for collecting spent dialysate. The solution bag and the drainage bag are connected to a three-way valve via a connector and a hose assembly.

[0003] Connecting the tube sets to the corresponding bags traditionally requires a rather complex construction, where for example a connector with a special cross-sectional geometry is glued or welded between the two film layers of the bag so that the films are flush with the connector, thus ensuring a tight seal.

[0004] If the bag serving as solution bag is empty, the bag is usually filled with ready-to-use dialysate, for example via a filling port specially provided for this purpose.

[0005] This procedure increases the number of individual components required for the bag system and also involves a significant amount of time in filling the bag through the filling port. Summary of the Invention

[0006] Based on this background, the present invention aims to alleviate or even completely eliminate the problems existing in the prior art. Specifically, the present invention aims to provide an economical and easy-to-fill peritoneal dialysis bag system.

[0007] This object is achieved by a bag system having the features of claim 1 and a method having the features of claim 8 .

[0008] Advantageous further modifications of the invention are the subject matter of the dependent claims.

[0009] Therefore, a bag system for peritoneal dialysis is provided, comprising a solution bag and a drain bag, which are preferably fluidically connected to each other via a three-way valve. The solution bag and / or the drain bag further each comprise an edge formed by a folded film, on which at least one connector is arranged by butt welding.

[0010] Attaching the connector to the edge formed by the folded film preferably offers the advantage that the connector is located at the outermost layer of the folded film and is not integrated into the folded film or its layer structure or inserted between two layers of film forming the bag.

[0011] Preferably, the term "butt welding" refers to a method of welding two end surfaces together. Butt welding is also called mirror welding.

[0012] For example, a butt-weld connection can consist of a pipe segment. First, the pipe segment is widened at one end, preferably in a tulip shape, to form a larger end face in the form of a flange. The end face of the pipe segment is then placed on a surface, such as a membrane, and welded thereto.

[0013] In this process, the end faces of the tube segments are located on the surface of the membrane, rather than being integrated into the membrane, for example being arranged between layers of a multilayer membrane or inserted between two membranes in the case of a multilayer membrane.

[0014] Butt welding can be used to create particularly strong and resilient connections.

[0015] A plurality of connecting elements can be arranged on the edge of the bag formed from the folded film, wherein at least one connecting element, preferably all connecting elements, are arranged on the film by butt welding.

[0016] According to one embodiment, the solution bag and the drainage bag have the same structure. This makes the design of the bag system particularly simple. Preferably, the solution bag and the drainage bag have no filling port except for their respective butt-welded connections.

[0017] It is also conceivable that the solution bag and / or the drainage bag are respectively provided with a sealing seam on the side opposite to the connector, the sealing seam preferably having one or more hanging holes. The width of the sealing seam is preferably such that the hanging hole is completely surrounded by the sealing seam.

[0018] According to one embodiment, the solution bag and / or the drain bag has a receiving area which is delimited on three sides by sealed seams and on one side by a folded film.

[0019] Before the bag system is used for peritoneal dialysis, the receiving area of ​​the solution bag is preferably filled with ready-to-use dialysate, and the receiving area of ​​the drain bag is empty. At the beginning of a peritoneal dialysis treatment cycle, spent dialysate from the previous treatment cycle is drained from the patient's peritoneal cavity into the drain bag. The contents of the solution bag are then transferred to the patient's peritoneal cavity.

[0020] According to one embodiment, at least the solution bag and preferably the drainage bag has no filling opening, in particular in the form of a nipple, port or connector, for filling the receiving area of ​​the bag.

[0021] Preferably, such a filling port is understood to be an access to the receiving area of ​​the bag, which is configured to fill 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 using a sealing cap.

[0022] According to one embodiment, the connection piece of the solution bag and / or the drain bag is welded in such a way that it is located at the outermost layer of the folded film and is not integrated into the folded film, the two folded layers of film or the layer structure of the film.

[0023] For example, the connecting piece can be made of a pipe section, or comprise a pipe section. Preferably, the pipe section forms the connecting piece so that the pipe section is directly butt-welded to the film of the bag.

[0024] In the region of the connecting piece, the bag preferably has an opening in the membrane, through which the contents can flow out of the receiving region of the bag.

[0025] According to one embodiment, the solution bag, the drain bag, and the tubing sets fluidly connecting the bags are made of a polymer material and are preferably configured as single-use items or disposables.

[0026] A further aspect of the invention relates to the use of the bag system according to the invention for peritoneal dialysis.

[0027] Furthermore, the present invention relates to a method for producing a bag system according to the invention, comprising the following steps:

[0028] a) providing a flat film having two outer edges, wherein the flat film can be a multilayer film or a single-layer film;

[0029] b) fixing at least one connecting element to the flat membrane by butt welding and producing an opening in the flat membrane, preferably in the region of the connecting element, for example by punching or using a hot rod;

[0030] c) forming the flat film into a film tube, preferably by forming a shoulder and sealing the outer edges of the flat film together;

[0031] d) producing a sealing seam extending perpendicularly or substantially perpendicularly to the longitudinal direction of the film tube, thereby producing a receiving pocket in the film tube;

[0032] e) selectively filling the receiving bag with a medical solution, preferably a ready-to-use dialysate, along the longitudinal direction of the film tube; and

[0033] f) closing the receiving bag by producing an additional second sealing seam extending perpendicularly or substantially perpendicularly to the longitudinal direction of the film tube, which second sealing seam is spaced apart from the first sealing seam in the longitudinal direction of the film tube, thereby closing the receiving bag and forming a bag.

[0034] The individual bags are then separated from the film tube by separation along first and second sealing seams extending transversely to the longitudinal direction of the film tube.

[0035] Two such bags are then used in the bag system according to the invention, wherein one bag has been filled according to step e) and serves as a solution bag, while the other bag is initially empty and serves as a drainage bag.

[0036] In other words, to produce the bag system according to the invention, preferably two bags produced by the method according to the invention are provided, one of which is filled according to step e) and the other is empty, and each bag is connected to a common three-way valve by a butt-welded connection. Filling is preferably carried out vertically from above.

[0037] According to one embodiment of the method of the invention, bags are continuously manufactured along a continuous film tube, each bag being connected to each other via a sealing seam, and the bags are separated from each other by separation along the sealing seam extending perpendicularly or substantially perpendicularly to the longitudinal direction of the film tube.

[0038] The butt welding in step b) preferably adopts the following parameters:

[0039] Soldering temperature: 150℃≤T≤300℃

[0040] Welding time: 0.7s≤t≤2s

[0041] Welding pressure: 0.1N / mm 2 ≤σ≤2N / mm 2

[0042] The following parameters are particularly preferred:

[0043] Soldering temperature: 190℃≤T≤250℃

[0044] Welding time: 0.9s≤t≤1.5s

[0045] Welding pressure: 3000N, where A=6300mm 2 →0.48N / mm 2

[0046] Preferably, the bags are manufactured continuously along a continuous film tube, the bags being each connected to one another via a sealing seam, the bags being separated from one another by separation along transverse sealing seams extending perpendicularly or substantially perpendicularly to the longitudinal direction of the film tube.

[0047] In other words, a continuous film tube is preferably produced, for example, which is filled with ready-to-use dialysate in the longitudinal direction of the tube and divided into different bags by transverse sealing.

[0048] Thus, for example, when the tube is filled, a column of filling material is produced which is divided by transverse seals into a plurality of bags which can be used as solution bags of the bag system of the present invention.

[0049] Preferably, steps a) to f) of the method according to the invention are performed by a single machine.

[0050] According to one embodiment of the method of the present invention, filled bags and unfilled drain bags are manufactured on different production lines and then combined to form a bag system. For example, filled solution bags are manufactured on a first machine and unfilled drain bags are manufactured on a second machine.

[0051] At this point, it should be noted that the present disclosure is not limited to the explicitly disclosed feature combinations, but that the features disclosed herein can also be claimed in other combinations or in isolation. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Further advantages, effects and features of the present invention will be apparent from the following description of preferred embodiments with reference to the accompanying drawings, in which like reference characters designate like or similar components.

[0053] in:

[0054] Figure 1 A conventional bag system for peritoneal dialysis is shown;

[0055] Figure 2 shows a bag system for peritoneal dialysis according to the present invention; and

[0056] Figure 3 A process for continuously manufacturing bags from a continuous film tube that can be used within the scope of the present invention is shown. DETAILED DESCRIPTION

[0057] Figure 1 A bag system 1 according to the invention for peritoneal dialysis is shown, comprising a bag 2 (also called solution bag) filled with a solution, eg ready-to-use dialysate, and an empty bag 3 (also called drainage bag), eg for receiving spent dialysate.

[0058] The bags 2 and 3 each have a connector or connection piece 4 which is arranged between two layers of film of the bag which are welded together in the region of the connection piece 4. In other words, each connection piece 4 is arranged between the film layers forming the bag 2 or 3 and is surrounded by them.

[0059] The bag 2 further comprises a filling port 5 which is non-detachably closed by a sealing cap 6. The filling port 5 is used to fill the bag 2 with a solution (eg, dialysate).

[0060] Once the bag 2 is filled to the desired volume, the filling opening 5 is permanently closed by the sealing cap 6 , so that the end user cannot open the filling opening 5 .

[0061] The bags 2 and 3 can each be fluidly connected to a three-way valve 8 via a tube 7 or line or to a three-way valve 8 via a tube 7 or line. The three-way valve 8 is preferably also connected to a patient connector 9.

[0062] Using the three-way valve 8 , fresh dialysate can be conveyed from the bag 2 to the patient via the patient connector 9 , and used dialysate can be conveyed from the patient into the drain bag 3 via the patient connector 9 .

[0063] The bag 2 may be placed in an elevated position relative to the patient, such as in a gravimetric peritoneal dialysis system, so that the dialysate flows from the bag 2 to the patient connector 9 due to gravity.

[0064] For this purpose, the bag 2 also has a hanging area 10 with hanging eyelets 11 .

[0065] Figure 1 The disadvantages of conventional bag systems are shown to be inter alia the following:

[0066] - the connection 4 provided between the foils of the individual bags 2 , 3 involves high production costs;

[0067] - a filling port 5 is required to fill the bag 2; and

[0068] - Filling the bag 2 via the filling opening 5 .

[0069] Figure 2 A bag system 1 according to the invention for peritoneal dialysis is shown, comprising a bag 2 (also called solution bag) filled with a solution, eg ready-to-use dialysate, and an empty bag 3 (also called drainage bag), eg for receiving spent dialysate.

[0070] According to this embodiment, the solution bag 2 and the drainage bag 3 preferably have the same structure.

[0071] The bags 2 and 3 each have a receiving area 10, the receiving area of ​​the solution bag 2 preferably being filled with fresh dialysate, whereas the receiving area of ​​the drain bag is initially empty but can be gradually filled with spent dialysate.

[0072] The receiving area 10 of each of the bags 2 and 3 is delimited by a sealed seam at a first and a second opposite side 11 and 12 respectively.

[0073] The bags 2 , 3 also each have a third edge 13 formed from a folded film, on which at least one connecting element 7 is non-detachably arranged by butt welding.

[0074] The bags 2, 3 have a fourth side 14 opposite the third side 13, with a sealed seam 15 in which at least one hanging eyelet 16 is provided.

[0075] The bags 2 , 3 are each preferably made of a flat film: a film tube is initially formed by folding the film at a third side 13 and sealing the outer edges of the flat film together at a fourth side 14 to form a sealed seam 15 .

[0076] A transverse sealing seam is then formed perpendicularly to the longitudinal direction of the film tube, defining a first side 11 of each bag 2 , 3 .

[0077] In this intermediate state, the receiving area 10 is still open on the side of each bag 2, 3 opposite the first side 11 and can therefore be easily filled as required. The bag can also remain empty.

[0078] This eliminates the need for a filling port 5 on the solution bag 2. After the receiving area 10 has been filled, the receiving area 10 of each bag 2, 3 is closed by forming a transverse sealing seam provided on the second side 12 of the bag.

[0079] Figure 3 An example of continuous manufacturing of bags from a continuous film tube is shown, which may be used within the scope of the present invention.

[0080] Figure 3 The membrane tube 17 shown is preferably Figure 3 The filling process is shown extending in the vertical direction.

[0081] The film tube 17 is made from a flat film by folding the film and sealing the outer edges of the flat film together at a sealing seam 15 .

[0082] like Figure 3 As shown, the film tube 17 contains four bags, namely two solution bags 2 (one of which is filled and sealed, and the other is being filled) and two drain bags 3 (whose receiving areas 10 are empty).

[0083] The solution bags 2 and the drainage bags 3 are alternately arranged along the longitudinal direction of the film tube 17 .

[0084] It is also conceivable to arrange only the solution bag 2 or only the drainage bag 3 in the film tube 17. If the solution bag 2 and the drainage bag 3 are arranged in the frame of the film tube 17, the relative arrangement between them is arbitrary.

[0085] like Figure 3 As shown by the film tube 17 , the bags 2 and 3 are not yet separated from each other, but are connected to each other via a common transverse sealing seam on the edges 11 , 12 , respectively.

[0086] The folded side of the flat film forms the third side 13 ( Figure 3 On the left side), a sealed seam 15 forms a fourth side 14 of each bag 2 , 3 .

[0087] Each bag 2 , 3 is provided with at least one butt-weld connection 7 on its third side 13 .

[0088] Figure 3 The top bag shown in FIG illustrates the filling of the receiving area 10 of the solution bag 2. In this bag 2, the receiving area 10 is Figure 2 The upper end is shown as not yet closed or sealed, thereby forming a receiving pocket 18 for fill material.

[0089] The receiving bag 18 is filled with a specific content, such as dialysate as indicated by hatching, preferably from vertically above using a separate filling device, such as a filling lance 19. Once the receiving bag 18 is sufficiently filled, it is closed by a transverse seal.

[0090] This filling method does not require a filling port 5 for each solution bag 2. In addition, compared with the conventional filling method using a filling port 5, the filling speed can be increased.

[0091] In order to separate the individual bags 2 , 3 of the continuous film tube 17 from one another, they are cut open in the transverse direction along the common transverse sealing seam on the edges 11 , 12 .

[0092] The bags 2 and 3 can then be used as part of a bag system according to the invention.

Claims

1. A bag system for peritoneal dialysis, comprising a solution bag and a drainage bag, wherein the solution bag and the drainage bag are fluidically connected to each other, preferably via a three-way valve, characterized in that The solution bag and / or the drain bag each comprises an edge formed from a folded film, on which at least one connection element is arranged by butt welding.

2. The bag system according to claim 1, characterized in that The solution bag and the drainage bag are of the same design.

3. The bag system according to claim 1 or 2, characterized in that The solution bag and / or the drainage bag comprises a respective sealing seam on the side opposite to the connecting piece, the sealing seam preferably having a hanging eyelet.

4. Bag system according to any one of the preceding claims, characterized in that The solution bag and / or the drain bag comprises a receiving area which is bounded on three sides by sealed seams and on one side by a folded film.

5. Bag system according to any one of the preceding claims, characterized in that At least the solution bag and preferably the drain bag have no filling opening, in particular in the form of a nipple, port or connector, for filling the receiving area of ​​the bag.

6. Bag system according to any one of the preceding claims, characterized in that The connection element of the solution bag and / or the drain bag is welded in such a way that it is located on the outermost layer of the folded film and is not integrated into the folded film, the two folded layers of the film or the layer structure of the film.

7. Bag system according to any one of the preceding claims, characterized in that The solution bag and the drain bag, as well as the tubing sets fluidly connecting the bags, are made of a polymer material and are preferably configured as disposable items.

8. A method for manufacturing a bag system according to any one of claims 1 to 7, comprising the following steps: a) providing a flat membrane having two outer edges; b) securing at least one connecting element to the flat membrane by butt welding; c) forming a film tube from the flat film by sealing the outer edges of the flat film together; d) producing a sealing seam extending perpendicularly or substantially perpendicularly to the longitudinal direction of the film tube, thereby producing a receiving pocket in the film tube; e) selectively filling the receiving bag with a medical solution, preferably a ready-to-use dialysate, along the longitudinal direction of the film tube; as well as f) closing the receiving bag by producing an additional second sealing seam, which extends perpendicularly or substantially perpendicularly to the longitudinal direction of the film tube and is spaced apart from the first sealing seam in the longitudinal direction of the film tube, thereby closing the receiving bag and forming a bag.

9. The method according to claim 8, characterized in that Bags are manufactured continuously along a continuous film tube, each bag being connected to one another via a sealing seam, and the bags being separated from one another by sealing seams extending perpendicularly or substantially perpendicularly to the longitudinal direction of the film tube.

10. The method according to claim 9, characterized in that Two bags manufactured according to the method of claim 5 are provided, one bag being filled according to step e) and the other being empty, and each bag being connected to a common three-way valve by a respective butt-weld connection.

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