Medical bag and method for the production thereof

Abstract

The present invention relates to a medical bag (1), which is filled with an enteral or parenteral food solution and comprises at least one first chamber (12a). The bag (1) is made from welded-together plastic films (11). An inner container (20) is inserted in the bag (1), said inner container comprising a port (30d-30h) which is welded into a weld seam (14a) of the bag (1).

Description

[0001] Medical bag and method for its manufacture

[0002] Description

[0003] Field of the invention

[0004] The invention relates to a medical bag filled with a nutritional solution for enteral or parenteral nutrition. The invention further relates to an inner container designed for such a medical bag. The invention further relates to a method for producing a medical bag.

[0005] Background of the invention

[0006] For enteral and parenteral nutrition, bags made of welded foils are used. Such a bag includes a withdrawal port, which is particularly designed as a connector. The medical fluid can be withdrawn and transferred to the patient via a withdrawal port, which can be pierced, for example, with a spike or needle. Furthermore, such a medical bag usually also includes an injection port, through which a fluid, such as a medication, can be transferred into the bag.

[0007] Medical bags for enteral and parenteral nutrition are usually designed as multi-chamber bags. Such a three-chamber bag is known, for example, from published patent application EP 1 621 178 A1. The bag comprises three chambers, one containing a glucose-containing solution, another containing an amino acid-containing solution, and another containing a lipid-containing solution or emulsion. Separating the individual components of the nutritional solution ensures its long shelf life. The components of the nutritional solution are only mixed together immediately before use.

[0008] For this purpose, the multi-chamber bag known from the aforementioned prior art comprises so-called peel seams, which separate the individual chambers from one another. Such a peel seam is a welded seam that can be opened by applying pressure, for example by means of rollers. Before use, the multi-chamber bag is rolled, in particular starting from the bottom seam where the hanger is arranged, whereby the peel seams tear open and the individual chambers are connected to one another. The then ready-mixed nutritional solution can then be transferred to the patient.

[0009] It is often desirable for the patient to receive additional additives, such as vitamins or trace elements, along with the nutritional solution. This can be accomplished with a multi-chamber bag using the injection port. However, this is laborious for the user. When using a powder component, the user must even dissolve it beforehand in order to then transfer it into the medical bag via the injection port.

[0010] The published patent application JP 2015-131056 A2 shows a two-chamber container which comprises an inner container which can be filled with a medicament, for example.

[0011] However, providing such an inserted inner container is technically difficult from a production perspective. In particular, it is difficult to provide an additional station in a filling system for aseptic filling where the inner container is inserted into the medical bag.

[0012] Object of the invention

[0013] The invention is therefore based on the object of reducing the aforementioned disadvantages of the prior art. It is a particular object of the invention to provide a medical bag in which an additional chamber for the additive of a medical nutritional solution can be easily provided. It is a further object of the invention to provide a medical bag which comprises an optionally usable chamber with an additive for the nutritional solution. In particular, the medical bag should be designed such that the integration of an additional chamber is particularly simple, even with a conventional method for producing a medical bag.

[0014] Summary of the invention

[0015] The object of the invention is already achieved by a medical bag, by an inner container designed for the medical bag and by a method for producing a medical bag according to one of the independent claims.

[0016] Preferred embodiments and further developments of the invention can be found in the subject matter of the dependent claims, the description and the drawings.

[0017] According to a first aspect, the invention relates to a medical bag which is filled with an enteral or parenteral nutrition solution and comprises at least one first chamber, wherein the bag is formed from plastic films welded together.

[0018] According to the invention, an inner container is inserted into the bag, which inner container comprises a port welded into the weld seam of the bag. The port is, in particular, welded into an outer weld seam of the bag.

[0019] The outer seal forms the edge or boundary of the bag. The outer seal is, in particular, a non-peelable seal. The outer seal is generally provided by the bag's two transverse seals and two longitudinal seals.

[0020] In one embodiment of the invention, the port is arranged in a transverse weld seam, preferably the so-called head weld seam.

[0021] The invention therefore provides an additional inner container which is welded to the bag via the port.

[0022] The inner container can in particular be designed as a foil bag.

[0023] Attaching the inner container over the port is particularly easy during production and the inner container can be securely connected to the rest of the bag.

[0024] The medical bag can therefore comprise an outer bag into which the inner bag is inserted.

[0025] For the purposes of the invention, the medical bag into which the inner container, in particular the inner bag, is inserted can also be defined as an outer bag on its own, i.e., without the inner container. When reference is made below to chambers of the medical bag, this refers to the chambers of the outer bag and not the chamber formed by the inner bag.

[0026] If the medical bag, in particular the outer bag itself, is designed as a multi-chamber bag, the inner bag can optionally be opened easily and independently of the chambers of the outer bag.

[0027] For example, the medical bag, in particular the outer bag, may comprise peel seams which can be opened by applying pressure, for example by rolling and / or pressing.

[0028] An additional chamber is provided above the inner bag, which can contain an additive for the nutritional solution. Depending on the intended use, the user can decide whether or not to open the inner bag, for example, by applying pressure.

[0029] The port of the inner container and / or a port of the outer bag is preferably designed as a connector. Such a connector comprises a welded lower part and an upper part. A seal is arranged between the upper and lower parts.

[0030] In one embodiment of the invention, at least one first port of the medical bag, in particular of the outer bag, which is connected to the first chamber, is welded into the weld seam in which the port of the inner container is welded.

[0031] Preferably, all ports of the medical bag are welded in a single weld seam. This simplifies production. The inner container, in particular designed as an inner bag, can be prefilled with a medicinal liquid and / or a powder component for production. If a medicinal liquid is provided, the inner container is preferably filled via the port of the inner container.

[0032] The ready-made inner container can be placed between the films of the medical bag or the outer bag and then sealed when at least one port of the outer bag is sealed.

[0033] If the inner container is designed as a film bag, the port, in particular the connector, is preferably welded to the films of the inner container.

[0034] When welding the bag, the weld seam of the bag, especially the outer bag, may extend over the weld seam of the inner container.

[0035] According to another embodiment, the weld seam of the port of the inner container is arranged next to the weld seam of the bag, in particular the outer bag.

[0036] In a preferred embodiment of the invention, the inner container is designed such that it can be opened by applying pressure.

[0037] The pressurisation can be achieved in particular by squeezing the inner container together or by rolling the inner container together with the medical bag.

[0038] For opening by pressure application, the inner container may include at least one peel seam. The peel seam is designed as an external weld seam, i.e., after the peel seam is opened by pressure application, a fluid connection is established between the inner container and the at least one chamber of the medical bag.

[0039] According to a preferred embodiment, the medical bag is designed as a multi-chamber bag, in particular as a two- or three-chamber bag.

[0040] For the purposes of the invention, this refers to the chambers of the outer bag.

[0041] This comprises in particular a first chamber with a glucose-containing filling, a second chamber with an amino acid-containing solution and a third chamber with a lipid-containing solution or emulsion.

[0042] The chambers of the outer bag are preferably separated from each other by peel seams, which can be opened by applying pressure.

[0043] The inner container can be filled with a powder component and / or a liquid.

[0044] A powder component may in particular comprise a powder with vitamins and / or trace elements.

[0045] A medicinal liquid in the inner container may in particular comprise vitamins and / or trace elements.

[0046] Furthermore, electrolyte-containing solutions may be present in the inner container.

[0047] According to one embodiment of the invention, a chamber formed by the inner container is filled with 5 to 50 ml, preferably 20 to 30 ml, of medicinal liquid. Furthermore, a chamber formed by the inner bag can be filled with 0.5 to 10 g, preferably 1 to 3 g, of a

[0048] Powder component. In one embodiment of the invention, the chambers of the medical bag, i.e., the outer bag, are filled with a total of 150 to 600 ml, preferably 400 to 500 ml, of medical fluid. The filling volume of a chamber of the inner container can be 1 to 10%, preferably 3 to 8%, of the total filling volume of the chambers of the medical bag, i.e., the outer bag.

[0049] The volume of the inner container is primarily used for dosing additives and is therefore relatively small.

[0050] In a further development, the inner container is designed as a multi-chamber container, in particular as a two-chamber container.

[0051] In particular, the inner container may comprise an internal peel seam that separates the first chamber of the inner container from the second chamber of the inner container.

[0052] Preferably, the inner container comprises a second, outer peel seam which provides a fluid connection to the outer bag after opening.

[0053] The peel seam can in particular be designed as a transverse weld or longitudinal weld.

[0054] For the purposes of the invention, the transverse welds are considered to be the welds arranged parallel to a weld in which the ports are welded, the so-called head weld. The longitudinal welds run transversely, in particular perpendicularly, to this. Preferably, the inner container is provided with a peel seam on exactly one side only. This facilitates opening the inner container.

[0055] In particular, it is provided that a first chamber of the inner container is filled with a medicinal liquid and a second chamber of the inner container is filled with a powder component. In a further embodiment, it is provided that both a first chamber of the inner container is filled with a medicinal liquid and a second chamber of the inner container is filled with a medicinal liquid.

[0056] When the inner container is pressurized, the pressure on the liquid in the first chamber creates a force that opens the peel seam between the first and second chambers.

[0057] The medicinal fluid then flows into the second chamber and further pressure application opens a peel seam of the second chamber, which provides a fluid connection to the outer bag.

[0058] This eliminates the need for a gas volume in the chamber of the inner container containing the powder component, which would also allow the peel seam to be opened by applying pressure.

[0059] According to a further aspect, the invention relates to a medical bag. This bag can, in particular, comprise the features described above.

[0060] The medical bag is filled with an enteral or parenteral nutrition solution and comprises at least a first chamber, the bag being formed from welded plastic films.

[0061] According to the invention, an inner container designed as a film bag is inserted into the bag, which inner container comprises at least two chambers, a first chamber being filled with a liquid and a second chamber being filled with a powder component. The first chamber is separated from the second chamber of the inner container by a peel seam. In particular, the inner container is welded into an outer weld seam of the bag.

[0062] As already described above, according to this aspect of the invention, the medicinal liquid in the first chamber of the inner container can be used to initially provide a fluid connection between the first chamber of the inner container and the second chamber of the inner container.

[0063] The medicinal liquid, which is now located in both chambers, is then preferably used to open another outer peel seam of the inner container, via which a fluid connection is provided between the inner container and the outer bag.

[0064] The peel seams can in particular be provided as transverse weld seams.

[0065] Preferably, a first peel seam is arranged as an inner peel seam, via which only a fluid connection can be established between the first chamber and the second chamber of the inner container.

[0066] The longitudinal weld seams are preferably not designed as peel seams. Particularly in the case of an inner container designed as a two-chamber bag, only a single outer weld seam is preferably present.

[0067] This allows sufficient pressure to build up to open this outer peel seam.

[0068] According to a further aspect of the invention, this relates to a medical bag, which can in particular comprise the features described above.

[0069] The medical bag is filled with an enteral or parenteral nutrition solution and comprises a first chamber and a second chamber, the bag being formed from plastic films welded together.

[0070] According to the invention, an inner container is inserted into the bag, which is welded at the edge in a weld seam, in particular in a head weld seam, of the medical bag.

[0071] The invention therefore relates to a multi-chamber bag in which the outer bag in the sense of the invention is designed in particular as a two-chamber or three-chamber bag.

[0072] In addition, an inner container is provided, which is preferably designed as an inner bag and which is welded into a head weld seam of the medical bag.

[0073] The inner container may or may not include a port.

[0074] In particular, according to this aspect of the invention, an inner container can be provided, preferably designed as a film bag, which is welded on the side of the ports of the medical bag.

[0075] In this way, the multi-chamber bag can be provided with an additional chamber in a particularly simple manufacturing process, which can be opened independently of the chambers of the outer bag.

[0076] As described above, the inner bag preferably comprises a peel seam through which a fluid connection to the chamber of the outer bag can be provided.

[0077] The peel seam is preferably arranged on the side of the inner bag opposite the head weld seam.

[0078] According to one embodiment, the bag, in particular the outer bag, and / or the inner bag is made of a polypropylene film.

[0079] According to one embodiment, the bag and inner bag are made of the same film material. This facilitates the recycling of the bag.

[0080] In particular, the film is designed as a multilayer polypropylene film. It is therefore a film that comprises polypropylene as a main component, which, in particular, forms a PP matrix, as explained below. The film is preferably PVC-free.

[0081] The multilayer film has at least three, preferably exactly three, layers. The layers are bonded together. In particular, the layers are welded together by co-extrusion and subsequent joining while hot. The inner layer is in contact with the medicinal liquid. The outer layer encompasses, at least in sections, the surface of the medical packaging designed as a bag.

[0082] In the inner bag, the outer layer of the film is in contact with the liquid that is filled into the bag.

[0083] According to one embodiment, the multilayer film comprises at least one inner layer made of a matrix phase polymer system, a middle layer made of a matrix phase polymer system and an outer layer made of a matrix phase polymer system.

[0084] In a matrix-phase-polymer system, at least two different polymers are present, with one polymer being demixed, in particular as dispersed solidified drops, in the matrix of the other polymer.

[0085] The matrix polymer of the matrix-phase polymer system of the inner layer, the middle layer, and the outer layer each comprises a polypropylene polymer. In particular, the matrix consists of a polypropylene.

[0086] The phase polymer of the matrix-phase polymer system of the inner layer, the middle layer and the outer layer each comprises at least one styrene-ethylene / butylene-styrene block copolymer (SEBS) as phase polymer.

[0087] SEBS is a block polymer composed of styrene, butylene, and ethylene segments, which includes a hydrogenated butadiene segment followed by styrene groups. It is produced by polymerizing a styrene and butadiene monomer, followed by hydrogenation of the previously polymerized SBS. The hydrogenated butadiene forms a soft central block between the styrene blocks.

[0088] According to one embodiment of the invention, the matrix polymer of the outer layer is not a PP random copolymer, but a polypropylene homopolymer. This results in a strong, impact-resistant outer layer and / or improved diffusion resistance of the layer package.

[0089] The invention further relates to an inner container designed as a foil bag for insertion into the medical bag described above.

[0090] The inner container, designed as a foil bag, preferably comprises at least one outer welded seam. The inner container can be opened by applying pressure via this peel seam.

[0091] In a further development of the invention, the inner container designed as a film bag is designed as a two-chamber bag and comprises an inner peel seam and an outer peel seam.

[0092] The inner peel seam serves to provide a fluid connection between the first chamber of the inner bag and the second chamber of the inner bag.

[0093] The inner bag is opened via the outer peel seam.

[0094] A peel seam differs from other weld seams in that, when used as intended, it can be opened by applying pressure or pulling apart. Peel seams are created during the manufacture of a film bag by using a different weld seam than the other weld seams on the film bag, for example, at a lower temperature, with lower welding tool pressure, and / or with a shorter welding time. These other weld seams are therefore non-peelable when used as intended.

[0095] The invention further relates to a method for producing a medical bag, in particular a bag as described above.

[0096] The procedure includes the following steps:

[0097] - Providing an upper and a lower slide;

[0098] - Providing an inner container which comprises at least one port;

[0099] - Insert the inner container between the upper and lower films;

[0100] - Welding the upper film to the lower film to form a bag with at least one chamber, wherein the port of the inner container is welded into at least one weld seam.

[0101] The port is in particular welded into a head weld seam of the medical bag, into which at least one further port for providing a fluid connection to the first chamber of the bag is also welded.

[0102] In a preferred embodiment of the invention, the inner container is sealed into a bag after the upper and lower films have been sealed.

[0103] It is therefore particularly provided that a pocket is initially provided, in particular by welding two longitudinal welds and one transverse weld, which later forms the outer bag. Instead of two longitudinal welds, it is provided according to another embodiment that a tube made of a film is used, which is provided on one side with a

[0104] A transverse weld seam is welded. Even when provided as a hose, two longitudinal weld seams can be formed.

[0105] The inner container is then inserted into the bag. A head weld is used to weld the connectors, which provide fluid communication to the chambers of the outer bag, as well as the port of the inner container.

[0106] According to one embodiment of the invention, an inner container is provided which is already prefilled with a powder component and / or a liquid.

[0107] The filling of the medical bag, namely the filling of the chambers of the outer bag, is preferably carried out after the inner container has been welded in via the ports of the bag.

[0108] In a further embodiment of the invention, the inner container can also be filled via the port of the inner container after the head weld seam has been welded.

[0109] In particular, the inner container and outer bag can be filled in a single filling station.

[0110] Furthermore, an inner container can be provided in which a first chamber is filled or pre-filled with a liquid and a second chamber is filled with a powder component. An inner container can also be provided in which both a first chamber and a second chamber are filled with a liquid. In particular, the chamber that is filled with liquid can be filled with the remaining bag after the inner container has been sealed.

[0111] Preferably, the medical bag is filled, then packed in a secondary packaging and then sterilized, in particular by autoclaving.

[0112] The secondary packaging can be designed as a film bag, in particular as a tear-open film.

[0113] Preferably, the secondary packaging is made of a multi-layer film, in particular of a multi-layer polypropylene film.

[0114] The secondary packaging may comprise a barrier layer to protect against oxygen diffusion and / or a layer to protect against light. The barrier layer may, in particular, be formed as an aluminum and / or silicon oxide layer. The barrier layer may, in particular, also be formed as an aluminum and / or polysiloxane layer.

[0115] According to a further aspect, the invention relates to a method for producing a medical bag, in particular a bag as described above, comprising the steps of:

[0116] - Providing an upper and a lower slide;

[0117] - Providing an inner container which comprises at least one port;

[0118] - Insert the inner container between the upper and lower films;

[0119] - Provide at least one port:

[0120] - Welding the upper film to the lower film to form a bag with at least one chamber, wherein both the port and the inner container are welded in at least one weld seam, in particular a head weld seam.

[0121] According to the invention, at least one port, in particular a port providing fluid access to a chamber of the bag, is welded into the same weld seam as the inner container. This particularly facilitates the integration of the inner container into an existing production process.

[0122] The inner container can be pre-filled and placed in a bag. The ports are then prepared and sealed with a top seam.

[0123] A weld seam of the inner container can be located below the head weld seam or offset to the side.

[0124] Brief description of the drawings

[0125] The subject matter of the invention will be explained in more detail below with reference to exemplary embodiments shown in the drawings Fig. 1 to Fig. 14.

[0126] Fig. 1 is a plan view of a medical bag according to a first embodiment of the invention.

[0127] Fig. la is a detailed view of area A of Fig. 1

[0128] Fig. 2 to Fig. 8 show various alternative embodiments of a medical bag according to the illustration in Fig. 1.

[0129] Fig. 9 is a side view of a medical bag. Figs. 10 to 13 are plan views of further embodiments of a medical bag according to the invention.

[0130] Fig. 14 is a flowchart of the method steps of an embodiment of a method for manufacturing a medical bag according to the invention.

[0131] Detailed description of the drawings

[0132] Fig. 1 shows a plan view of a lying medical bag 1, a first embodiment of the invention.

[0133] The medical bag 1 is designed as a film bag made of welded films 11 and comprises a bag 10, which is also defined as an outer bag 10 in the sense of the invention.

[0134] The bag 10 is a multi-chamber bag.

[0135] In this embodiment, the bag is divided into three chambers 12a - 12c.

[0136] Bag 10 is filled with an enteral or parenteral nutrition solution.

[0137] The components of the nutritional solution are distributed into chambers 12a - 12c.

[0138] For example, a glucose-containing solution can be located in chamber 12a, an amino acid-containing solution in chamber 12b, and a lipid-containing solution in chamber 12c. The films 11 are connected to one another via longitudinal weld seams 13a, 13b and transverse weld seams 14a, 14b. This forms a bag 1 filled with a medicinal liquid. The two longitudinal weld seams 13a and 13b as well as the two transverse weld seams 14a and 14b are the outer weld seams of the bag 1. They form the bag 1 and the edge of the bag 1, respectively. They delimit the interior of the bag 1. These outer or edge weld seams 13a, 13b, 14a, and 14b are generally permanent and therefore non-peelable weld seams.

[0139] The films 11 are joined together, in particular, by means of an impulse welding process. The films 11 are welded together using a welding tool with heatable sealing strips that come into contact with the film. This occurs by temporarily heating the sealing strips so that the films clamped between the sealing strips become molten, at least in sections, and are thus welded together. Such an impulse welding process is known, for example, from published patent application EP 0 911 141 A2.

[0140] A front transverse weld seam 14a, in which the connectors 30a - 30d, which form the ports, are welded, is also referred to as head weld seam 14a in the sense of the invention.

[0141] The chambers 12a - 12c are separated from each other by the peel seams 16a and 16b.

[0142] In this embodiment, the peel seams 16a, 16b extend from the head weld seam 14a to the transverse weld seam 14b. The peel seams 16a and 16b comprise a stepped tear-open zone 17. When the bag 1 is rolled, the peel seams 16a, 16b preferably tear open starting from or in the region of the tear-open zone 17, so that the chambers 12a-12c are connected to one another and the components of the nutritional solution mix.

[0143] The bag 1 includes a hanger 15 for hanging the bag on a rack or stand. The hanger 15 can be designed as a cut or punched-out section.

[0144] The bag further comprises three ports 30a-30c, through which the three chambers 12a-12c can each be filled. The bag 1 comprises a removal port 30a, which provides a fluid connection to the chamber 12a or the interior volume of the bag 1 after opening the peel seams 16a, 16b.

[0145] Furthermore, the bag 1 comprises an injection port 30b, which in this embodiment provides fluid access to the chamber 12b or, after tearing open the peel seams 16a, 16b, to the entire internal volume.

[0146] Medications and / or additives for the nutritional solution can be added via the injection port 30b.

[0147] Another port 30c provides fluid access to chamber 12c. Port 30c serves only to fill chamber 12c and is therefore designed as a blind port.

[0148] The ports 30a - 30c are designed as connectors 30a - 30c, each of which is designed to close the bag 1 and serves for removing and / or filling the bag 1. Fig. 1a shows a connector 30a in a detailed view of area A.

[0149] The connector 30a comprises a lower part 31, via which a fluid connection to the internal volume is provided.

[0150] The lower part 31 comprises a welded section 32, which is welded into the head weld seam 14a. The welded section 32 can, in particular, be boat-shaped.

[0151] The lower part 31 is closed with an upper part 34.

[0152] Between the lower part 31 and the upper part 34 is a sealing element, for example a septum (not shown in the figure), which closes the fluid passage and can be pierced with a spike or needle. After the spike or needle is removed, the septum closes automatically. The septum can be made, in particular, of polyisoprene.

[0153] In this embodiment, the upper part 34 is closed with a breakable cap 35. After breaking off the cap 35, the septum is accessible.

[0154] In the case of ports or connectors 30c, 30d which are not used for the withdrawal or injection of liquid by the user, the port or connector 30c is designed as a blind port and does not include a break-off cap 35. Otherwise, such a blind port or blind connector 30c is designed identically.

[0155] The connector 30a shown in Fig. 1a preferably also serves to fill the medical bag 1, in particular the chamber 12a. For this purpose, the lower part 31 comprises a flexible, squeezable neck 33. In a filling system, the connector 30a can be grasped at the neck 33. The squeezable neck 33 serves as a valve.

[0156] The chambers 12a-12c of the medical bag are filled, then preferably the neck 33 is squeezed shut. Subsequently, the upper parts 34 are pressed onto the lower parts 31.

[0157] The connectors 30a - 30c are closed so that the neck 33 no longer needs to be squeezed.

[0158] Fig. 1 further shows that the medical bag 1 comprises an inner container 20, in this embodiment designed as an inner bag 20.

[0159] The inner bag 20 is made of films 21 welded together.

[0160] The films 21 are connected via longitudinal weld seams 23a and 23b.

[0161] An outer transverse weld seam 24 is designed as a peel seam 24.

[0162] In this embodiment, the inner bag 20 comprises a connector 30d. The connector 30d is designed as a blind port. In this embodiment, the connector 30d serves solely for filling the inner bag 20.

[0163] An additional chamber 22a is provided in the multi-chamber bag 10 via the inner bag 20.

[0164] During the production of the medical bag, the inner bag 20 can be provided prefilled. The inner bag 20 is inserted between the films 11 of the outer bag 10, with at least the head weld seam 14a not yet set.

[0165] The inner bag 20a is then connected to the outer bag 10 via the head weld seam 14a during welding.

[0166] The head weld seam 14a extends over the weld section 32 of the connector 30d.

[0167] In this embodiment, a head weld seam of the inner container 20 lies below or in the head weld seam 14a of the bag 10 or outer bag 10. The weld seams therefore overlap.

[0168] The inner bag 20 can be opened by applying pressure. This opens the peel seam 24, and the contents of chamber 22a mix with the liquid in chambers 12a-12c.

[0169] The inner bag 20 can be opened independently of the chambers 12a - 12c.

[0170] In particular, one or more inner bags can also be used to provide components whose use is only intended optionally. For example, if a particular additive is not required for the nutritional solution, the user does not open the corresponding inner bag 20.

[0171] Fig. 2 shows another embodiment of a medical bag 1.

[0172] In this embodiment, an inner bag 20a is designed as a two-chamber bag. The inner bag 20a, which is connected to the outer bag 10 as shown in Fig. 1, comprises a first chamber 22a and a second chamber 22b.

[0173] The chambers 22a and 22b are separated from each other by the peel seam 24a. In this embodiment, the peel seam 24a is formed as a transverse weld seam.

[0174] On the side opposite the head weld seam 14a there is an outer peel seam 24b.

[0175] The chamber 22a is preferably filled with a medicinal liquid, in particular a medicinal liquid containing vitamins and / or trace elements.

[0176] The chamber 22b can be filled with a powder component.

[0177] To open the chambers 22a, 22b, the user presses on the medical bag 1 in the area of ​​the inner bag 20a.

[0178] The resulting pressure of the medicinal fluid initially opens the peel seam 24a. The medicinal fluid can now flow into the chamber 22b.

[0179] The user then presses further, and the outer peel seam 24b opens, allowing the liquid now mixed with the powder to enter the interior volume of the medical bag 1. The liquid flowing into the chamber 22b can also directly open the outer peel seam 24b, thereby pushing the powder into the interior volume of the medical bag 1.

[0180] In one embodiment, a medical fluid is introduced into both the first chamber 22a and the second chamber 22b. Furthermore, the medical bag 1 can comprise another inner bag 20b, through which another chamber 22c is provided. The inner bag 20b is located in a different chamber 12b of the outer bag than the inner bag 20a.

[0181] This inner bag 20b can also be opened independently of the outer bag 10 by pressing. A further, third, chamber 22c is provided above the inner bag 20b.

[0182] In this embodiment, the inner bags 20a, 20b are both provided with a connector 30d, 30e. The connectors 30e and 30d are each designed as blind ports and are welded into the head weld seam 14a with their welded section 32.

[0183] The inner bag 20a is located in the first chamber 12a of the medical bag 1 or the outer bag 10.

[0184] The inner bag 20b is located in the second chamber 12b of the medical bag 1.

[0185] Chamber 12c is preferably filled with a lipid-containing solution. Preferably, there is no inner bag in this chamber 12c, since the liquid in chamber 12c is turbid.

[0186] An inner bag would not be visible or would only be difficult to see from the outside.

[0187] Fig. 3 shows another embodiment of a medical bag 1.

[0188] In this embodiment, the medical bag 1 contains a single inner bag 20a, which provides the chambers 22a and 22b. Otherwise, the medical bag 1 is designed as described above.

[0189] Referring to Fig. 4, it is shown how the medical bag 1 is provided in a secondary packaging 40. The secondary packaging 40, in particular, provides a barrier against oxygen.

[0190] After filling the medical bag 1, it is packaged in a secondary packaging 40, which in this embodiment is also designed as a film bag, in particular as a tear-open bag.

[0191] The secondary packaging is formed from two films which are connected to each other via the longitudinal weld seams 41a, 41b and the transverse weld seams 42a, 42b.

[0192] Preferably, the medical bag 1 is autoclaved in the secondary packaging 40.

[0193] Fig. 5 shows another embodiment of a medical bag 1.

[0194] In this embodiment, the medical bag 1 comprises two inner bags 20a, 20b.

[0195] In this embodiment, the inner bags 20a, 20b are each designed as single-chamber bags and each provide an additional chamber 22a, 22b.

[0196] The inner bags 20a, 20b each comprise a peel seam 24 and can thus be opened by pressure. The inner bag 20a is designed as shown in Fig. 1 and comprises a port 30d, which is designed as a connector 30d.

[0197] The inner bag 20b, however, does not include a port.

[0198] The inner bag 20b is also preferably provided prefilled and is in particular filled with a medicinal liquid or a powder component.

[0199] The inner bag 20b is welded into the head weld seam 14a of the bag 1.

[0200] Since the connectors 30a - 30c are also located in the head weld seam, the connection via the head weld seam 14a is particularly advantageous from a production point of view.

[0201] In this embodiment, the

[0202] Head weld seam 14a with the underlying weld seam of the inner bag 20b.

[0203] Fig. 6 shows another embodiment of a medical bag 1.

[0204] In contrast to the embodiment shown in Fig. 5, the inner bag 20b is now also provided with a port or connector 30e. The inner bag 20b preferably contains a liquid, which has been filled via the port 30e.

[0205] Fig. 7 shows a further embodiment in which two inner bags 22a, 22b are present, each designed as a two-chamber bag. The additional

[0206] Chambers 22a, 22b, 22c and 22d are provided.

[0207] Both inner bags 20a, 20b comprise an inner peel seam 24a and an outer peel seam 24b.

[0208] The inner bag 20a comprises a connector or port 30d.

[0209] The inner bag 20b, on the other hand, does not include a connector and is again welded into the head weld seam 14a.

[0210] Chambers 22a and 22c may contain a medicinal liquid, and chambers 22b and 22d may contain a powder component. In another embodiment, both chambers 22b and 22d, or one of the chambers 22b or 22d, are filled with a medicinal liquid.

[0211] Fig. 8 shows another embodiment of a medical bag 1.

[0212] In contrast to the embodiment shown in Fig. 7, the inner container 20b now also comprises a port or connector 30e.

[0213] The two inner bags 20a and 20b can be inserted completely filled. This means that both chambers 22c and 22d, as well as 22a and 22b, are already filled when the inner bags 20a and 20b are inserted and sealed. In another embodiment, at least one of the chambers 22a or 22c can initially be provided empty and then filled or co-filled when the three large chambers 12a-12c are filled. Filling takes place via an initially open connector 30e or 30d, which is then closed by placing the blind cap.

[0214] Fig. 9 shows a side view of a medical bag 1 according to another embodiment. It shows the connector 30a, designed as a withdrawal port, which is welded between the foils 11.

[0215] The films 11 form a bag 1 which is filled with medicinal liquid and, as shown in the plan view of the lying bag according to Fig. 10, comprises several chambers 12a - 12c.

[0216] In this embodiment, too, the chambers 12a - 12c are separated from each other by peel seams 16a, 16b.

[0217] In this embodiment, however, the peel seam 16a extends from a head weld seam 14a to a longitudinal weld seam 13a.

[0218] The chamber 12a therefore occupies the entire width of the internal volume of the medical bag 1 in an area opposite the head weld seam 14a.

[0219] In this embodiment, an inner bag 20a is located in the chamber 12c, which provides additional volume and includes a peel seam 24. The inner container 20a is sealed on the long sides by the longitudinal weld seams 23a, 23b.

[0220] The inner container 20a comprises a connector or port 30d, which has a welded section 32 which is welded into the head weld seam 14a of the bag 1.

[0221] In contrast to the previously presented embodiments, the inner container comprises a weld seam 25 designed as a head weld seam, which is arranged laterally next to the head weld seam 14a of the bag 1 or inner bag 10. The head weld seam 25 of the inner bag 20a thus extends parallel to the head weld seam 14a of the outer bag 10.

[0222] Fig. 11 is another embodiment of a medical

[0223] Bag 1

[0224] In contrast to the embodiment shown in Fig. 10, there is an inner bag 20a, 20b in both the chamber 12b and the chamber 12c.

[0225] Both inner bags 20a, 20b comprise a connector or port 30d, 30e.

[0226] The two inner bags 20a and 20b can be inserted filled. Both inner bags 20a and 20b are already filled when inserted and sealed. In another embodiment, at least one inner bag 20a or 20b can initially be inserted empty and sealed, and then filled or co-filled when filling the three chambers 12a-12c. Filling occurs via an initially open connector 30e or 30d, which is then closed by placing the blind cap.

[0227] Fig. 12 shows a further embodiment with an inner bag 20a, which is designed as a multi-chamber bag with the chambers 22a and 22b.

[0228] In contrast to the previously illustrated embodiments, the chambers 22a, 22b are separated from each other by a longitudinal weld seam 23c.

[0229] In one embodiment, both chambers 22a, 22b are sealed with a single or continuous outer peel seam 24 and are opened by applying pressure. Both chambers 22a, 22b are connected to a port or connector 30d, 30e.

[0230] Via such a plurality of chambers 22a, 22b arranged next to one another, various additives for the nutritional solution can be provided in a simple manner, which additives can optionally be released into the inner volume of the bag 1 by pressing on the respective chamber 22a, 22b.

[0231] In a further embodiment, the seam 23c arranged between the two chambers 22a, 22b is also designed as a peel seam.

[0232] Fig. 13 shows, in one embodiment, a medical bag 1 in which an inner bag designed as a single-chamber bag is arranged in the chamber 12a and an inner bag 20b, 20c designed as a two-chamber bag is arranged in the chambers 12c and 12b, as shown in Fig. 12.

[0233] This provides five additional chambers containing a medical fluid.

[0234] All chambers are closed with a connector 30d - 30h.

[0235] Fig. 14 is a flowchart of an embodiment of the method for manufacturing a medical bag according to the invention.

[0236] First, an upper and a lower slide are provided 50.

[0237] The films 11 are welded together to form a pocket 51. The pocket is open in the area of ​​the future head weld seam 14a. Three chambers 12a-12c are then created by welding peel seams 52. The peel seams can be created during the welding of the film to form a pocket 51 or even in advance.

[0238] Then, a preferably filled inner bag 20a-20c with a connector is inserted 53 into at least one of the chambers 12a-12c.

[0239] Furthermore, the lower part 31 of a connector 10a-30h for a withdrawal port and an injection port is inserted 54 in a head seam area between the foils 11.

[0240] The head seam 14a is then welded 55.

[0241] Subsequently, the chambers 12a-12c of the bag 1 are filled with a medicinal liquid 56.

[0242] The extraction and injection ports are closed by bouncing the upper parts 34 57.

[0243] The bag 1 is then packed 58 with a secondary packaging 40 and subsequently autoclaved 59.

[0244] The invention made it possible to provide a medical bag 1, in particular a multi-chamber bag, with an additional, optionally openable chamber containing a medical liquid or a powder component in a simple manner.

[0245] I Medical bag

[0246] 10 bags / outer bags

[0247] II Slide

[0248] 12a - 12c Chamber

[0249] 13a, 13b Longitudinal weld seam

[0250] 14a Cross weld / head weld

[0251] 14b Transverse weld seam

[0252] 15 trailers

[0253] 16a, 16b peel seam

[0254] 17 Tear zone

[0255] 20, 20a - 20c inner container / inner bag

[0256] 21 Slide

[0257] 22a - 22d Chamber (of the inner bag)

[0258] 23a, 23b Longitudinal weld seam

[0259] 24, 24a, 24b Peel seam / cross weld seam

[0260] 25 Weld / Head Weld

[0261] 30a - 30h Connector / Port

[0262] 31 Lower part

[0263] 32 Weld-in section

[0264] 33 neck

[0265] 34 top

[0266] 35 Break-off cap

[0267] 40 Secondary packaging

[0268] 41a, 41b Longitudinal weld seam

[0269] 42a, 42b transverse weld seam

[0270] 50 Providing an upper and a lower

[0271] film

[0272] 51 Welding the films into a bag

[0273] 52 Insertion of three chambers by welding peel seams

[0274] 53 Inserting a filled inner bag with a connector into at least one of the chambers 54 Inserting the lower part of a connector for a withdrawal port and an injection port in a head seam area

[0275] 55 Welding the head seam 56 Filling the chambers with a medical

[0276] liquid

[0277] 57 Closing the withdrawal and injection ports

[0278] 58 Packaging with secondary packaging

[0279] 59 Autoclaving

Claims

Claims:

1. Medical bag (1) which is filled with an enteral or parenteral nutrition solution and comprises at least one first chamber (12a), wherein the bag (1) is formed from plastic films (11) welded together, characterized in that an inner container (20) is inserted into the bag (1), which inner container comprises a port (30d- 30h) which is welded into an outer weld seam (14a) of the bag (1).

2. Medical bag (1) according to the preceding claim, characterized in that at least one first port (30a-30c) is welded into the weld seam (14a), which is connected to the first chamber (12a).

3. Medical bag (1) according to one of the preceding claims, characterized in that the inner container (20a-20c) is designed such that it can be opened by applying pressure.

4. Medical bag (1) according to one of the preceding claims, characterized in that the inner container is designed as a film bag with at least one peel seam (24, 24a, 24b).

5. Medical bag (1) according to one of the preceding claims, characterized in that the bag (1) is designed as a multi-chamber bag, in particular as a two- or three-chamber bag.

6. Medical bag (1) according to one of the preceding claims, characterized in that the inner container (20a-20c) with a powder component and / or a filled with liquid.

7. Medical bag (1) according to one of the preceding claims, characterized in that the inner container (20a-20c) is designed as a multi-chamber bag, in particular as a two-chamber bag.

8. Medical bag (1) according to one of the preceding claims, characterized in that the inner container (20a-20c) comprises at least one peel seam (24a, 24b), wherein the peel seam (24a, 24b) is designed in particular as a transverse weld or longitudinal weld of the inner container (20a-20c).

9. Medical bag (1), in particular according to one of the preceding claims, wherein the bag (1) is filled with an enteral or parenteral nutritional solution and comprises at least a first chamber (12a), wherein the bag (1) is formed from plastic films (11) welded together, characterized in that an inner container (20a-20c) designed as a film bag is inserted into the bag (1), which inner container comprises at least two chambers (22a, 22b), wherein a first chamber (22a) is filled with a liquid and a second chamber (22b) is filled with a powder component, and wherein the first chamber (22a) is separated from the second chamber (22b) of the inner container (20a-20c) by a first peel seam (24a).

10. Medical bag (1) according to the preceding claim, characterized in that the inner container (20a-20c) is welded into an outer weld seam (14a) of the bag (1).

11. Medical bag (1) according to one of the two preceding claims, characterized in that the first chamber (22a) of the inner container (20a-20c) comprises a second peel seam (14b) for providing a fluid connection to the first chamber (12a) of the bag (1).

12. Medical bag (1) according to one of the preceding claims, characterized in that the inner container (20a-20c) comprises a single peel seam (24a) via which only one fluid connection can be established between the first chamber (22a) and the second chamber (22b) of the inner container (20a-20c).

13. Medical bag (20) according to one of the preceding claims, characterized in that the first and / or second peel seam (24, 24a-24b) of the inner container (20a-20c) is / are designed as transverse weld seam(s), in particular wherein longitudinal weld seams (23a-23b) of the inner container (20a-20c) are not designed as peel seams.

14. Medical bag (1) according to one of the preceding claims, characterized in that the inner container (20a-20c) is filled with an electrolyte-containing solution, vitamins and / or trace elements.

15. Medical bag (1), in particular according to one of the preceding claims, which is filled with an enteral or parenteral nutritional solution and comprises at least a first chamber (12a) and a second chamber (12b), wherein the bag (1) is formed from plastic films (11) welded together, characterized in that an inner container (20a-20c) is inserted into the bag (1), which is formed at the edge in a weld seam (14a) of the bag (1).

16. Medical bag (1) according to the preceding claim, characterized in that the inner container (20a-20c) is welded into a head weld seam (14a) of the bag (1).

17. An inner container (20a-20c) designed as a film bag for insertion into a medical bag (1) according to one of the preceding claims, in particular wherein the inner container (20a-20c) comprises an inner peel seam (24a) and an outer peel seam (24b).

18. A method for producing a medical bag, in particular a medical bag according to one of the preceding claims, comprising the steps: - Providing an upper and a lower film (50); - Providing an inner container (20a-20c) which comprises at least one port (30d-30h); - Inserting the inner container between the upper and lower films (53); - Welding the upper film to the lower film to form a bag with at least one chamber, wherein the port (30d-30h) of the inner container (20a-20c) is welded (55) in at least one weld seam (14a).

19. Method according to one of the preceding claims, characterized in that at least one further port (30a) is welded into the weld seam (14a) to provide a fluid connection to the first chamber (12a) of the bag (1).

20. Method according to one of the preceding claims, characterized in that the inner container (20a-20c) is welded into a bag (55) after the upper and lower films have been welded together.

21. Method according to the preceding claim, characterized in that the provided inner container (20a-20c) is prefilled with a powder component and / or a liquid and / or that the inner container (20a-20c) is provided as a two-chamber bag 22. Method according to the preceding claim, characterized in that a first chamber (22a) of the inner container (20a-20c) is filled with a liquid and a second chamber (22b) of the inner container (20a-20c) is filled with a powder component or a liquid, or that a second chamber (22b) of the inner container (20a-20c) is filled with a powder component or a liquid and a first chamber (20b) of the inner container is filled with a liquid after the films (11) have been welded.

23. A method for producing a medical bag, in particular according to one of the preceding claims, comprising the steps: - Providing an upper and a lower film (50); - Providing an inner container (20a-20c) which comprises at least one port (30d-30h); - Inserting the inner container between the upper and lower films (53); - Providing at least one port (30a-30c); - Welding the upper film to the lower film to form a bag with at least one chamber, wherein both the port (30a-30c) and the inner container (20a-20c) are welded in at least one weld seam (14a), in particular a head weld seam.

24. Method according to one of the preceding claims, characterized in that the bag (1) is filled, packed in a secondary packaging (40) and / or then sterilized, in particular by autoclaving.

25. Medical bag (1) comprising an inner container (20a-20c) designed as a film bag according to claim 15 and / or producible, in particular produced, by a method according to one of the preceding claims.

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