Bag system for peritoneal dialysis

Abstract

The present invention relates to a bag system for peritoneal dialysis, comprising a bag containing a solution, and a drainage bag, which are fluidically interconnected, preferably via a three-way valve, the bag containing the solution and the drainage bag each having a side formed by a folded-over film, and at least one port being formed at this side by way of butt welding. The present invention further relates to a method for producing a bag system of this type.

Description

[0001] i

[0002] Bag system for peritoneal dialysis

[0003] The present invention relates to a bag system for peritoneal dialysis and a method for producing such a bag system.

[0004] Bag systems for peritoneal dialysis are known from the state of the art. Each bag contains a solution bag containing fresh dialysate and a drainage bag for collecting used dialysate. The solution bag and drainage bag are connected to a three-way valve via a connector and a tubing set.

[0005] The connection of the hose set to the respective bag traditionally requires a rather complicated structure, in which, for example, connectors with a special cross-sectional geometry, which are intended to enable the film to be placed flush with the connector and thus to ensure a tight seal, are glued or welded between two film layers of a bag.

[0006] Once a bag intended for use as a solution bag is fully formed, it is typically filled with ready-to-use dialysate, for example, via a dedicated fill port after production. This procedure increases the number of individual parts required for the bag system and also involves a significant amount of time for filling the bag through the fill port.

[0007] Against this background, the present invention is based on the object of mitigating or even completely eliminating the problems of the prior art. In particular, the present invention is based on the object of creating a cost-effective and easy-to-fill bag system for peritoneal dialysis.

[0008] This object is achieved by a bag system having the features of claim 1 and a method having the features of claim 8.

[0009] Further advantageous modifications of the invention are the subject of the subclaims.

[0010] Accordingly, a bag system for peritoneal dialysis is provided, comprising a solution bag and a drainage bag, which are fluidically connected to each other, preferably via a three-way valve. The solution bag and / or the drainage bag further comprise a side formed by a folded-over film, to which at least one connection is arranged by butt welding.

[0011] Attaching the connector to the side formed by a folded film preferably offers the advantage that the connector sits on an outermost layer of the folded film and is not integrated into the folded film or its layer structure or is interposed between two layers of film forming a bag.

[0012] The term butt welding preferably refers to a process in which two end faces are butt-welded together. Butt welding is also known as mirror welding. For example, the butt-welded connection can comprise a hose section. First, one end face of the hose section is widened, preferably in a tulip shape, to create a larger end face similar to a flange. The end face of the hose section is then placed on a surface, such as a film, and welded to it.

[0013] In this procedure, the end face of the tube section then sits on the surface of the film and is not integrated into it, for example in the case of a multi-layer film, it is arranged between the layers of the multi-layer film or sandwiched between two films.

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

[0015] A plurality of connections can be arranged on the side of the bag formed by a folded film, at least one of which, preferably all of which, are arranged on the film by means of butt welding.

[0016] According to one embodiment, the solution bag and the drainage bag are designed identically. This enables a particularly simple design of the bag system. Preferably, neither the solution bag nor the drainage bag has a filling port in addition to the butt-welded connection.

[0017] Furthermore, it is conceivable for the solution bag and / or the drainage bag to each have a sealed seam, preferably with one or more hanging loops, on a side opposite the connection. The sealed seam is preferably wide enough so that the hanging loop(s) are completely enclosed by the sealed seam. According to one embodiment, the solution bag and / or the drainage bag each has a receiving area that is bordered on three sides by a sealed seam and on one side by a folded-over film.

[0018] Before using the bag system for peritoneal dialysis, the receiving area of ​​the solution bag is preferably filled with ready-to-use dialysate, and the receiving area of ​​the drainage bag is empty. At the start of each peritoneal dialysis treatment cycle, the used dialysis solution from the previous treatment cycle is drained from the patient's peritoneal cavity into the drainage bag. The contents of the solution bag are then transferred into the patient's peritoneal cavity.

[0019] According to one embodiment, at least the solution bag and preferably also the drainage bag does not have a filling port for filling a receiving area of ​​the bag, preferably in the form of a connection, port or connector.

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

[0021] According to one embodiment, the connection of the solution bag and / or drainage bag is welded such that it rests on an outermost layer of the folded film and is not integrated into the folded film, two folded layers of the film or a layer structure of the film.

[0022] The connection can, for example, consist of a hose section or comprise a hose section. Preferably, the hose section forms the connection, so that the hose section is butt-welded directly to the film of the bag.

[0023] In the area of ​​the connection, the bag preferably has an opening in the film through which contents can flow out of the receiving area of ​​the bag.

[0024] According to one embodiment, the solution bag and the drainage bag as well as a hose set fluidically connecting these bags are made of a polymer material and are preferably designed as single-use items or disposable.

[0025] Another aspect of the present invention relates to the use of a bag system according to the invention for peritoneal dialysis.

[0026] Furthermore, the present invention relates to a method for producing a bag system according to the invention, comprising the steps of: a) providing a flat film with two outer edges; wherein the flat film can be a multi-layer or single-layer film, b) fixing at least one connection to the compartment film by butt welding, and preferably creating an opening in the flat film in the region of the connection, for example by punching or by means of a hot mandrel, c) producing a film tube from the flat film, preferably by means of a forming shoulder and sealing the outer edges of the flat film to one another, d) creating a first sealing seam running at right angles or substantially at right angles to a longitudinal direction of the film tube, thereby creating a receiving pocket, e) optionally filling the receiving pocket along the longitudinal direction of the film tube with a medicinal solution, preferably ready-to-use dialysate;and f) closing the receiving pocket by creating a further second sealing seam running at right angles or substantially at right angles to the longitudinal direction of the film tube and spaced from the first sealing seam in the longitudinal direction of the film tube, whereby the receiving pocket is closed and a bag is formed;

[0027] This is followed by a separation along the first and second sealing seams, which run transversely to the longitudinal direction of the film tube, whereby a single bag is separated from the film tube.

[0028] Two such bags are then used in a bag system according to the invention, wherein one of the bags has been filled according to step e) and serves as a solution bag and the other bag is initially empty and serves as a drainage bag.

[0029] In other words, to produce a bag system according to the invention, two bags manufactured using a method according to the invention are preferably provided, one bag being filled according to step e) and the other bag being empty, and the bags each being connected by their butt-welded connection to a common three-way valve. Filling preferably takes place vertically from above.

[0030] According to one embodiment of a method according to the invention, bags are continuously produced along a continuous film tube, each bag being connected to one another via a sealing seam, which bags are each separated from one another by cutting along a sealing seam running at right angles or substantially at right angles to the longitudinal direction of the film tube.

[0031] During butt welding in step b), the following parameters are preferably used:

[0032] Welding temperature: 150°C < T < 300°C

[0033] Welding time: 0.7 s < t < 2 s

[0034] The following parameters are particularly preferred: Welding pressure: 0.1 N / mm 2 < a < 2 N / mm 2

[0035] Welding temperature: 190°C < T < 250°C

[0036] Welding time: 0.9 s < t < 1 .5 s

[0037] Welding pressure: 3000N at A=6300mm 2 — ► 0.48 N / mm 2

[0038] Preferably, bags are produced continuously along a continuous film tube, each of which is connected to one another via a sealing seam, and which are each separated from one another by cutting along a transverse sealing seam running at right angles or substantially at right angles to the longitudinal direction of the film tube.

[0039] In other words, a continuous film tube is preferably produced, which is filled, for example, with ready-to-use dialysate in the longitudinal direction of the tube and which is portioned into different bags by sealing in the transverse direction.

[0040] Thus, when filling the tube, for example, a column of filling material is created, which is divided into several bags by transverse sealing, which can serve as solution bags within the framework of a bag system according to the invention.

[0041] Preferably, steps a) to f) of a method according to the invention are carried out with a single machine.

[0042] According to one embodiment of a method according to the invention, the filled bags and the unfilled drainage bags are produced on separate production lines and subsequently combined to form the bag system. For example, the filled solution bags are produced on a first machine, while the drainage bags are produced on a second machine. It should be noted at this point that the present disclosure is not limited to the explicitly stated combinations of features, but the features disclosed herein may also be claimed in other combinations or in isolation.

[0043] Further advantages, effects and features of the present invention will become apparent from the following description of preferred embodiments with reference to the drawings, in which like reference numerals designate like or similar components.

[0044] This shows:

[0045] Fig. 1 a conventional bag system for peritoneal dialysis;

[0046] Fig. 2 shows a bag system for peritoneal dialysis according to the invention, and

[0047] Fig.3 shows a continuous production of bags from a continuous film tube, which can be used in the context of the present invention.

[0048] Fig. 1 shows a conventional bag set 1 with a bag 2 filled with a solution, for example ready-to-use dialysate (also referred to as solution bag) and an empty bag 3 (also referred to as drainage bag), for example for receiving used dialysate.

[0049] Bags 2 and 3 each have a connector or connection 4, which is arranged between two film layers of the bag that are welded together in the area of ​​the connection 4. In other words, each connection 4 is arranged between the film layers forming bags 2 or 3 and is enclosed by them. Bag 2 also has a filling port 5, which is permanently sealed with a closure cap 6. The filling port 5 serves to fill bag 2 with a solution, for example, dialysate.

[0050] If the bag 2 is filled with a desired volume, the filling port 5 is permanently closed with the closure cap 6 in such a way that an end user cannot open the filling port 5.

[0051] The bags 2 and 3 are each fluidically connectable or connected to a three-way valve 8 via a hose 7 or a line. The three-way valve 8 is preferably also connected to a patient connector 9.

[0052] By means of the three-way valve 8, fresh dialysate can be supplied from the bag 2 to a patient via the patient connector 9 and used dialysate can be supplied from the patient via the patient connector 9 into the drainage bag 3.

[0053] The bag 2 can be arranged elevated relative to the patient, for example in a gravimetric peritoneal dialysis system, so that the dialysate flows from the bag 2 to the patient connector 9 due to gravity.

[0054] For this purpose, the bag 2 has a hanging area 10 with a hanging eyelet 11.

[0055] Disadvantages of a conventional bag system shown in Fig. 1 are in particular:

[0056] - the connections 4 arranged between the films of the respective bag 2,3, which involve high manufacturing costs,

[0057] - the need for a filling port 5 for filling the bag 2, and

[0058] - filling the bag 2 via the filling port 5. Fig. 2 shows a bag system 1 according to the invention for peritoneal dialysis with a bag 2 filled with a solution, for example with ready-to-use dialysate (also referred to as solution bag) and an empty bag 3 (also referred to as drainage bag), for example for receiving used dialysate.

[0059] According to the present embodiment, the solution bag 2 and the drainage bag 3 are preferably constructed identically.

[0060] The bags 2 and 3 each have a receiving area 10, which in the case of the solution bag 2 is preferably filled with fresh dialysate and in the case of the drainage bag is initially empty, but can be successively filled with used dialysate.

[0061] The receiving area 10 of each bag 2, 3 is delimited on a first and a second opposite side 11 and 12 by a sealing seam each.

[0062] Each of the bags 2, 3 further comprises a third side 13 formed by a folded-over film, to which a hose or connection 7 is permanently arranged by butt welding.

[0063] Opposite the third side 13, each of the bags 2, 3 has a fourth side 14 with a sealing seam 15, in which at least one hanging eyelet 16 is provided.

[0064] Each of the bags 2, 3 is preferably produced from a flat film by folding the film at the third side 13 and sealing the outer edges of the flat film together at the fourth side 14 to form the sealing seam 15, thereby initially forming a film tube. A transverse sealing seam is then formed transversely to a longitudinal direction of the film tube, which delimits the first side 11 of each bag 2, 3.

[0065] In this intermediate state, the receiving area 10 is still open on the side opposite the first side 11 of each bag 2, 3, and can thus be easily filled if desired. The bag can also remain empty.

[0066] The need for a filling port 5 in the solution bag 2 is thus eliminated.

[0067] After filling the receiving area 10, the transverse sealing seam provided on the second side 12 of the bag is created, whereby the receiving area 10 of each bag 2, 3 is closed.

[0068] Fig.3 shows an example of a continuous production of bags from a continuous film tube, which can be used in the context of the present invention.

[0069] The film tube 17 shown in Fig. 3 preferably extends in the vertical direction during the filling shown in Fig. 3.

[0070] The film tube 17 was produced from a flat film by folding the film and sealing the outer edges of the flat film together in the sealing seam 15.

[0071] In the view shown in Fig. 3, the film tube 17 comprises four bags, namely two solution bags 2 (one of which is already filled and sealed and one of which is currently being filled) and two drainage bags 3 (the receiving area 10 of which is empty).

[0072] The solution bags 2 and drainage bags 3 are arranged alternately in the longitudinal direction of the film tube 17. However, this arrangement is merely exemplary; it is equally conceivable to provide only solution bags 2 or only drainage bags 3 within a film tube 17. If solution bags 2 and drainage bags 3 are provided within a film tube 17, their arrangement relative to one another is arbitrary.

[0073] In the view of the film tube 17 shown in Fig. 3, the bags 2 and 3 are not yet separated from each other, but are each connected to each other by a common transverse sealing seam on the sides 11, 12.

[0074] The folded side of the flat film forms the third side 13 (left in Fig. 3) of each bag 2, 3 and the sealing seam 15 forms the fourth side 14 of each bag 2, 3.

[0075] Each bag 2,3 is equipped with at least one butt-welded connection 7 on its third side 13.

[0076] The uppermost bag shown in Fig.3 illustrates the filling of the receiving area 10 of a solution bag 2. In this bag 2, the receiving area 10 is not yet closed or sealed at its upper end shown in Fig. 2 and therefore forms a receiving pocket 18 for filling material.

[0077] The receiving pocket 18 is filled with a specific content, such as the dialysate indicated by hatching, preferably vertically from above using a dedicated filling device, e.g., a filling lance 19. Once the receiving pocket 18 is sufficiently filled, it is sealed by transverse sealing.

[0078] This type of filling eliminates the need to equip each solution bag 2 with a filling port 5. Furthermore, the filling speed can be increased compared to conventional filling using a filling port 5. To separate the individual bags 2, 3 of the continuous film tube 17 from one another, they are cut apart transversely along the common transverse seal seam on the sides 11, 12.

[0079] The bags 2 and 3 can now be used within the framework of a bag system according to the invention.

Claims

Claims 1. Bag system for peritoneal dialysis, with a solution bag and a drainage bag, which are fluidically connected to one another preferably via a three-way valve, characterized in that the solution bag and / or the drainage bag each has a side formed by a folded-over film, on which at least one connection is arranged by butt welding.

2. Bag system according to claim 1, characterized in that the solution bag and the drainage bag are identically designed.

3. Bag system according to claim 1 or 2, characterized in that the solution bag and / or the drainage bag each has a sealing seam with preferably a hanging eyelet on a side opposite the connection.

4. Bag system according to one of the preceding claims, characterized in that the solution bag and / or the drainage bag has a receiving area which is delimited on three sides by a sealing seam and on one side by a folded film.

5. Bag system according to one of the preceding claims, characterized in that at least the solution bag and preferably also the drainage bag does not have a filling port for filling a receiving area of ​​the bag, preferably in the form of a connection, port or connector.

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

7. Bag system according to one of the preceding claims, characterized in that the solution bag and the drainage bag as well as a hose set fluidically connecting these bags are made of a polymer material and are preferably designed as a single-use item or disposable.

8. A method for producing a bag system according to the invention according to one of claims 1 to 7, comprising the steps of: a) providing a flat film with two outer edges; b) fixing at least one connection to the compartment film by butt welding, c) producing a film tube from the flat film by sealing the outer edges of the flat film together, d) producing a first sealing seam running at right angles or substantially at right angles to a longitudinal direction of the film tube, thereby creating a receiving pocket, e) Optionally filling the receiving pocket along the longitudinal direction of the film tube with a medicinal solution, preferably ready-to-use dialysate; and f) Closing the receiving pocket by creating a further second sealing seam running at right angles or substantially at right angles to the longitudinal direction of the film tube, which is spaced from the first sealing seam in the longitudinal direction of the film tube, whereby the receiving pocket is closed and a bag is formed.

9. Method according to claim 8, characterized in that bags are produced continuously along a continuous film tube, each of which is connected to one another via a sealing seam, which bags are each separated from one another by cutting along a sealing seam running at right angles or substantially at right angles to the longitudinal direction of the film tube.

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

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