Method and device for producing a bag with a butt-welded connection

Abstract

The invention relates to a method for producing a bag for receiving a medical product, in particular a dialysate, and / or a dry medical concentrate, having the steps of: providing a flat film with two outer edges, fixing at least one connection to the flat film by means of butt-welding, producing a film tube out of the flat film using a forming shoulder and by sealing the outer edges of the flat film together, producing a seal seam which runs perpendicularly or substantially perpendicularly to the longitudinal direction and / or the running direction of the film tube, whereby a receiving pocket is produced in the film tube, filling the receiving pocket along the longitudinal direction and / or the running direction of the film tube, preferably in the vertical direction from above, with liquid and / or solid contents, and closing the receiving pocket by producing an additional seal seam which runs perpendicularly or substantially perpendicularly to the longitudinal direction and / or the running direction of the film tube, whereby the receiving pocket is closed and a completely closed chamber is formed.

Description

[0001] Method and apparatus for producing a bag with a butt-welded connection

[0002] The present invention relates to a method and a device for producing a bag with at least one butt-welded connection.

[0003] In particular, the present invention relates to bags from the medical field, which are used, for example, for storing medical solutions, in particular dialysate or a component of dialysate, such as a concentrate. Further examples of medical solutions include aqueous solutions of sodium chloride, sodium citrate, or calcium chloride, as well as preparations for parenteral nutrition.

[0004] Traditionally, pouches in the medical sector are made from two layers of film that are sealed together. Connectors, connections, or ports of the pouches are usually sandwiched between the two layers of film. To do this, the two film layers must first be separated, then the connectors are inserted and the films are sealed.

[0005] In practice, leaks or weak spots often occur, particularly at the so-called triple points, which represent the transition between the two foils and the connection. Furthermore, welding a three-dimensional contour, such as that formed by the intermediate seal, requires complex tools.

[0006] Furthermore, thin spots in the film often occur in the area of ​​such welded connections, which can lead to weak spots in the bag.

[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 method and a device by means of which medical bags can be equipped with connections in a simple, durable, and cost-effective manner.

[0008] This object is achieved by a method having the features of claim 1 and a device having the features of claim 9. Furthermore, the present invention relates to a correspondingly manufactured bag.

[0009] Advantageous modifications of the invention are the subject of the subclaims.

[0010] Accordingly, a method is provided for producing a bag for receiving a medical device, preferably a medical solution, in particular dialysate, and / or a medical dry concentrate, comprising the steps of: a) providing a flat film with two outer edges; b) fixing at least one connection to the flat film by butt welding, c) producing a film tube from the flat film by means of a forming shoulder and by sealing the outer edges of the flat film to one another, d) producing a sealing seam running at right angles or substantially at right angles to a longitudinal direction and / or running direction of the film tube, whereby a receiving pocket is created in the film tube, e) filling the receiving pocket along the longitudinal direction and / or running direction of the film tube, preferably in a vertical direction from above and with a liquid and / or solid content;and f) closing the receiving pocket by creating a further sealing seam running at right angles or substantially at right angles to the longitudinal direction and / or running direction of the film tube, whereby the receiving pocket is closed and a completely closed chamber is formed;

[0011] In the broadest sense, steps a) and c) to f) are optional and a method according to the invention for producing a bag according to the invention is characterized in that according to step b) at least one connection of the bag is arranged or fixed to the bag by means of butt welding.

[0012] Attaching the connector to the film by butt welding preferably offers the advantage that the connector sits on an outermost layer of the folded film and is not integrated into the film or its layer structure or welded between two layers of film forming the bag.

[0013] 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.

[0014] For example, the butt-welded connection can comprise a hose section. First, the hose section is widened at one end face, preferably in a flange-like or tulip-shaped manner, to create a larger end face similar to a flange. The end face of the hose section is then butt-fitted to a surface, such as a film, and welded to it under pressure and heat. With this procedure, the end face of the hose section rests on the surface of the film and is not integrated into it or sandwiched between two films.

[0015] Butt welding can be used to create particularly strong and resilient connections.

[0016] A bag according to the invention can have a plurality of connections arranged thereon, of which at least one, preferably all, is / are arranged by butt welding on the film, preferably on a side formed by a folded film or the edge of the bag.

[0017] According to one embodiment, step b) of a method according to the invention comprises at least one of the following steps:

[0018] - Providing a cylindrical hose section,

[0019] - Preforming a connecting section of the hose section by local

[0020] Widening the hose, preferably at an end region of the hose section, whereby a flange-like connection section is formed, preferably by means of pressure and heat,

[0021] - Placing the connecting section onto the flat foil so that the flat foil is sandwiched between the connecting section and a pressure plate, and

[0022] - Welding the connecting section to the flat film by pressing the connecting section while exerting a counterpressure by means of the preferably heated pressure plate, whereby the connecting section is connected to the flat film and forms a connection.

[0023] The cylindrical hose section may have an outer diameter (length a in Fig.

[0024] 1 ) from 5 mm to 10 mm, preferably from 4.9 mm to 8 mm and an inner diameter (length b in Fig. 1 , diameter of the lumen) from 3 mm to 8 mm, preferably from 3.5 mm to 6 mm. According to one embodiment, in step b), a connection section is preformed at a temperature between 80 °C and 300 °C, preferably between 220 °C and 280 °C; for a period of time from 0.1 s to 4 s, preferably from 1.5 s to 3.5 s and with a pressure of 0.1 N / mm 2 up to 2 N / mm 2 , preferably 0.3 N / mm 2 up to 0.5 N / mm 2 This is illustrated in the table below:

[0025] Preforming parameters:

[0026] Welding temperature: 80°C 300°C

[0027] Welding time: 0.1 s 4 seconds

[0028] Welding pressure: 0.1 N / mm 2 2 N / mm 2

[0029] Preferably:

[0030] Welding temperature: 220°C 280°C

[0031] Welding time: 1.5 s 3.5 seconds

[0032] Welding pressure: 0.3 N / mm 2 0.5 N / mm 2

[0033] Furthermore, preferably in step b) during preforming, a flange-like connecting section of a hose section is formed, wherein a thickness of the flange-like connecting section (length c in Fig. 2) in the longitudinal direction of the hose section is between 0.1 mm and 2 mm, preferably between 0.3 mm and 0.5 mm, and in particular is approximately 0.4 mm, and a diameter of an end face of the flange-like connecting section (length d in Fig. 2) is between 5 mm and 25 mm, preferably between 10 mm and 14 mm and in particular is 12 mm.

[0034] In addition, in step b), a connecting section can be placed on the flat film, wherein a temperature of the connecting section, in particular of the flange-like connecting section, is at least partially between 200°C and 280°C.

[0035] A transfer time from a first position, in which the connecting section is initially spaced from the film, to a second position, in which the connecting section sits on the flat film, is from 0.1 s to 1 s. After preforming the connecting section, it is thus placed very quickly on the film and then welded to it.

[0036] Welding of the connecting section to the flat film in step b) can preferably be carried out with a temperature of the pressure plate of 80°C to 150°C, preferably of 90°C to 110°C for a period of time of 0.1 s to 4 s, preferably of 1.5 s to 3.5 s and a pressure of 0.1 N / mm 2 up to 2 N / mm2 , preferably 0.3 N / mm 2 up to 0.5 N / mm 2 take place.

[0037] In other words, the parameters for butt welding according to step b) can be as follows:

[0038] Contact temperature connection section (residual heat)

[0039] Welding temperature: 200°C < T < 280

[0040] °C

[0041] Welding time: 0.1 s < t < 4 s

[0042] Heated counterpressure plate foil

[0043] Welding temperature: 80°C < T < 150°C

[0044] Welding time: 0.1 s < t < 4 s

[0045] Welding pressure: 0.1 N / mm 2 < <j < 2 N / mm 2

[0046] Preferably:

[0047] Welding temperature: 90°C 110°C Welding time: 1.5 s 3.5 seconds

[0048] Welding pressure: 0.3 N / mm 2 0.5 N / mm 2

[0049] When welding film to film, for example to create seal seams or a peel seam, the following parameters can also be used:

[0050] Welding temperature: 150°C < T < 300°C

[0051] Welding time: 0.7 s < t < 2 s

[0052] Welding pressure: 0.1 N / mm 2 < <j < 2 N / mm 2

[0053] The following parameters are particularly preferred:

[0054] Welding temperature: 190°C < T < 250°C

[0055] Welding time: 0.9 s < t < 1 .5 s

[0056] Welding pressure: 3000N at A=6300mm 2 — ► 0.48 N / mm 2

[0057] Tensile tests

[0058] The stability of the butt-welded joint between bag film and tube was tested using tensile tests on a universal testing machine. Ten test specimens were manufactured and measured. The tensile tests were each repeated 10 times.

[0059] The results of the tensile tests are summarized in Table 1.

[0060] This means:

[0061] VS=Hose failure

[0062] VF=Failure Foil

[0063] VSS=weld failure

[0064] VST=Failure of tension point Table 1: Results of tensile tests

[0065] For a particularly efficient production of bags, completely closed chambers can be produced continuously along a continuous film tube, each connected to one another via a sealing seam, which 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 and / or running direction of the film tube, whereby separate bags are produced, each having one or more chambers.

[0066] In other words, several bags can be produced from one strand or film tube.

[0067] According to one embodiment, a bag manufactured using a method according to the invention can be a multi-chamber bag.

[0068] According to this embodiment, a peel seam running in the longitudinal direction is preferably also produced in the film tube, which peel seam releasably connects two layers of the film tube to one another, whereby in step d) two receiving pockets arranged next to one another and separated by the peel seam are produced, which in step e) are preferably filled by two separate filling lances each with a liquid, solid and / or pasty content which is designed for the production of dialysate.

[0069] Another aspect of the present invention relates to a device for fixing at least one connection of a film by butt welding, comprising:

[0070] - a holding device for holding a hose section with a preferably flange-like connection section,

[0071] - a receiving section in which the film can be positioned preferably in contact with the connecting section, and

[0072] - a movable and preferably heatable printing plate, wherein

[0073] - a control unit is provided which is programmed to control the device to carry out a method according to the present invention.

[0074] Preferably, the control unit is programmed to move and control the holding device and / or the pressure plate relative to each other in such a way that a connecting portion held in the holding device is pressed together with a film positioned in the receiving portion for a specific period of time and at a specific temperature and pressure, so that the connecting portion is butt-welded to the film and forms a connection.

[0075] A further aspect of the present invention relates to a bag manufactured according to a method according to the invention and / or with a device according to the invention and having at least one side formed by a folded film, to which at least one connection, preferably with a tube section, is permanently arranged by butt welding. The bag can be a multi-chamber bag with at least two chambers separated from one another by an openable peel seam.

[0076] Preferably, in addition to the at least one connection arranged on the bag by butt welding, the bag does not have a preferably permanently closed filling port which is designed to fill the bag or at least one chamber thereof with a desired content at the factory, i.e. preferably before the bag is delivered to the end user.

[0077] Such a filling port is preferably understood to mean an access to a receiving area of ​​the bag, which is designed to fill the receiving area of ​​the bag before delivery of the bag or a bag system comprising the bag to an end user or before use of the bag, for example, in peritoneal dialysis. After filling, the filling port is usually permanently closed, for example, with a cap.

[0078] Furthermore, the present invention relates to a bag system for peritoneal dialysis with a solution bag and a drainage bag which are connected to a common three-way valve, wherein the solution bag and / or the drainage bag is a bag according to the invention.

[0079] Preferably, steps a) to f) of a method according to the invention are carried out with a single machine.

[0080] At this point, it should be noted that the present disclosure is not limited to the explicitly mentioned combinations of features, but the features disclosed herein may also be claimed in other combinations or in isolation.

[0081] 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.

[0082] This shows:

[0083] Fig. 1 shows a hose section as can be used in the context of a method according to the invention;

[0084] Fig. 2 shows the hose section from Fig. 1 with a shaped connection section;

[0085] Fig.3 shows the process of butt welding in a device according to the invention, and

[0086] Fig. 4 is a schematic view of a bag according to the invention.

[0087] Fig. 1 shows a hose section 1 as it can be used in the context of a method according to the invention.

[0088] The tube section preferably consists of a polymer material and can have an outer diameter (length a in Fig. 1 ) of 5 mm to 10 mm, preferably of 4.9 mm to 8 mm and an inner diameter (length b in Fig. 1 , diameter of the lumen) of 3 mm to 8 mm, preferably of 3.5 mm to 6 mm.

[0089] As shown in Fig. 2, a tulip-shaped or flange-like connection section 2 is formed on the hose section 1 by expanding it under the influence of heat.

[0090] A thickness of the connecting section 2 in the longitudinal direction of the hose section (length c in Fig. 2) is between 0.1 mm and 2 mm, preferably between 0.3 mm and 0.5 mm, and in particular is approximately 0.4 mm. A diameter of an end face of the flange-like connecting section (length d in Fig. 2) is between 5 mm and 25 mm, preferably between 10 mm and 14 mm, and in particular is 12 mm.

[0091] Fig. 3 schematically shows a device according to the invention for butt welding. The device has a holding device in the form of two movable holding jaws 3, between which the hose section 1 is clamped and fixed.

[0092] The holding jaws 3 preferably completely surround the hose section 1 in their holding position.

[0093] A film 4 is positioned in a receiving section of the device and is in contact with the connecting section 2 of the hose section 1 .

[0094] In this arrangement, the film 4 is arranged between the connecting section 2 and a movable and heatable pressure plate 5. The pressure and heat of the pressure plate 5 weld the preheated connecting section 2 to the film 4 and firmly bond it.

[0095] Fig. 4 shows a schematic view of a bag 6 according to the invention, which is formed by folding over the film 4 and sealing two outer edges of the film 4 to form a sealing seam 7 on a side opposite the connection 8 formed by the tube section 1 connected to the film 4.

[0096] The sealing seam 7 has at least one hanging loop 9. The bag 6 is defined by a sealing seam on each of two opposite sides 10 and 11. In the area of ​​the connection 8, the film 4 has an opening 12 through which the contents of the bag 6 can flow outward through the connection 8.

[0097] The opening can be created, for example, by punching out the film before butt welding the connection or by inserting it into the film 4 using a hot mandrel after butt welding the connection.

Claims

Claims 1. A method for producing a bag for containing a medical device, preferably a medical solution, in particular dialysate, and / or a medical dry concentrate, 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 means of a forming shoulder and by sealing the outer edges of the flat film to one another, d) producing a sealing seam running at right angles or substantially at right angles to a longitudinal direction and / or running direction of the film tube, whereby a receiving pocket is created in the film tube, e) filling the receiving pocket along the longitudinal direction and / or running direction of the film tube, preferably in a vertical direction from above and with a liquid and / or solid content;and f) closing the receiving pocket by creating a further pocket running at right angles or substantially at right angles to the longitudinal direction and / or running direction of the film tube; Sealing seam, which closes the receiving pocket and forms a completely sealed chamber.

2. Method according to claim 1, characterized in that step b) of fixing at least one connection to the flat film by butt welding comprises at least one of the following steps: providing a cylindrical tube section, preforming a connection section of the tube section by locally expanding the tube, whereby a flange-like connection section is formed preferably by means of pressure and heat, placing the connection section on the flat film so that the flat film is intermediately stored between the connection section and a pressure plate, and welding the connection section to the flat film by pressing on the connection section while exerting counterpressure by means of the pressure plate, whereby the connection section is connected to the flat film and forms a connection.

3. Method according to claim 1 or 2, characterized in that in step b) a preforming of a connecting section is carried out at a temperature between 80°C and 300°C, preferably between 220°C and 280°C; for a period of time from 0.1 s to 4 s, preferably from 1.5 s to 3.5 s and with a pressure of 0.1 N / mm 2 up to 2 N / mm 2 , preferably 0.3 N / mm 2 up to 0.5 N / mm 2 , takes place.

4. Method according to one of the preceding claims, characterized in that in step b) a flange-like connecting section of a hose section is formed during preforming, wherein a thickness of the flange-like connecting section in the longitudinal direction of the hose section is between 0.1 mm and 2 mm, preferably between 0.3 mm and 0.5 mm and in particular is approximately 0.4 mm, and a diameter of an end face of the flange-like connection section is between 5 mm and 25 mm, preferably between 10 mm and 14 mm, and in particular is 12 mm.

5. Method according to one of the preceding claims, characterized in that in step b) a connecting section is placed on the flat film, wherein a temperature of the connecting section is at least partially between 200°C and 280°C.

6. Method according to one of the preceding claims, characterized in that in step b) the connecting section is welded to the flat film with a temperature of the pressure plate of 80°C to 150°C, preferably of 90°C to 110°C for a period of time of 0.1 s to 4 s, preferably of 1.5 s to 3.5 s and a pressure of 0.1 N / mm 2 up to 2 N / mm 2 , preferably 0.3 N / mm 2 up to 0.5 N / mm 2 occurs.

7. Method according to one of the preceding claims, characterized in that completely closed chambers are produced continuously along a continuous film tube, each connected to one another via a sealing seam, which 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 and / or running direction of the film tube, whereby separate bags are produced, each having one or more chambers.

8. Method according to claim one of the preceding claims, characterized in that the film tube further comprises a longitudinally extending peel seam is created which detachably connects two layers of the film tube to one another, whereby in step d) two receiving pockets arranged next to one another and separated by the peel seam are created, which in step e) are each filled by two separate filling lances with a liquid, solid and / or pasty content which is designed for the production of dialysate.

9. Device for fixing at least one connection of a film by butt welding, comprising: - a holding device for holding a hose section with a preferably flange-like connection section, - a receiving section in which the film can be positioned preferably in contact with the connecting section, and - a movable and preferably heatable printing plate, wherein a control unit is further provided which is programmed to control the device to carry out a method according to one of the preceding claims.

10. Device according to claim 9, wherein the control unit is programmed to move and control the holding device and / or the pressure plate relative to each other in such a way that a terminal section held in the holding device is pressed together with a film positioned in the receiving section for a specific period of time and at a specific temperature and pressure, so that the terminal section is butt-welded to the film and forms a terminal.

11. A bag which is manufactured according to a method according to one of the preceding claims 1 to 8 and / or with a device according to one of claims 9 or 10 and has at least one side which is formed by a folded film, to which at least one connection, preferably a tube section, is arranged in a non-detachable manner by means of butt welding.

12. Bag according to claim 11, characterized in that it is a multi-chamber bag with at least two chambers which are separated from one another by an openable peel seam.

13. Bag according to claim 11 or 12, characterized in that the bag, in addition to the at least one connection arranged on the bag by butt welding, does not have a preferably permanently closed filling port which is designed to fill the bag or at least one chamber thereof with a desired content at the factory.

14. Bag system for peritoneal dialysis with a solution bag and a drainage bag which are connected to a common three-way valve, characterized in that the solution bag and / or the drainage bag is a bag according to one of claims 11 to 13.

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