Bag which is filled with a medical fluid, and method for producing same

Abstract

The invention relates to a bag which is filled with a medical fluid and which is made from two films which are sealed along a bottom cross-seam, a top cross-seam, a first longitudinal seam, and a second longitudinal seam At least one extraction port is provided in the bottom cross-seam. The bag is divided into at least a first chamber, a second chamber, and a third chamber by a first peel seam and a second peel seam. The first peel seam comprises a first curved tear zone, and the second peel seam comprises a second curved tear zone. The first tear zone, starting from the bottom cross-seam, is positioned higher than the second tear zone.

Description

[0001] Bag filled with a medicinal liquid and method for its manufacture

[0002] Description

[0003] Field of the invention

[0004] The invention relates to a bag filled with a medical fluid. In particular, the invention relates to a three-chamber bag containing an enteral or parenteral nutritional composition. The invention further relates to a method for producing a medical bag.

[0005] Background of the invention

[0006] Foil pouches are often used for enteral or parenteral nutritional compositions. Such a foil pouch is equipped with at least one withdrawal port. This can be pierced with a spike or needle, allowing the nutritional composition to be transferred to the patient using a transfer set.

[0007] Such nutritional compositions generally comprise a glucose-containing solution, an amino acid-containing solution, and a fat emulsion. However, these components can only be stored separately for extended periods of time. The published patent application WO 2006 / 010410 A1 (applicant: Fresenius Kabi Deutschland GmbH) shows a three-chamber bag made of welded films. The bag is divided into three chambers by peel-weld seams. The largest chamber, which is generally filled with the glucose-containing solution, extends over the other two chambers in the upper area of ​​the bag. The peel-weld seams are weld seams that tear open when pressure is applied to the bag, in particular by rolling the bag up, particularly laterally, preferably from top to bottom, so that the contents of the three chambers can mix.

[0008] The medical bag described in the above document comprises peel seams with an S-shaped zone which supports the initial tearing of the peel welds.

[0009] Peel welds differ from other or permanent welds in that the material is less liquefied during welding, for example due to a lower welding temperature and / or a shorter contact time.

[0010] On the one hand, the peel seals must be sufficiently strong to prevent them from accidentally tearing during transport, thus opening the chambers. On the other hand, the peel seals should also be designed in such a way that the user does not have to exert excessive force, for example, when rolling the bag to exert sufficient pressure to open the peel seals.

[0011] It has been shown that it is more difficult to provide peel seals with good tear properties, especially for relatively small medical pouches. Especially for pediatric applications, the volume of medical fluid in the pouch is smaller, usually less than 2000 ml.

[0012] When the pouch is rolled up, the peel seals should open all the way down, i.e., to the lower transverse seal where the dispensing port is located. This is the only way to ensure thorough mixing of the various components of the nutritional composition. This is especially important for pediatric applications, as the pouch contents may only be partially used.

[0013] Object of the invention

[0014] The invention is based on the object of providing a multi-chamber bag, in particular a three-chamber bag, with improved tear-open properties of the peel-weld seams. The multi-chamber bag is intended in particular for pediatric applications.

[0015] Summary of the invention

[0016] The object of the invention is already achieved by a bag filled with a medicinal liquid and by a method for producing a bag filled with a medicinal liquid according to one of the independent claims.

[0017] Preferred embodiments and further developments of the invention can be found in the subject matter of the dependent claims, the description and the drawings.

[0018] The invention relates to a bag filled with a medicinal liquid, which is formed from two films, which are provided with a lower transverse weld seam and an upper transverse weld seam and with a first

[0019] Longitudinal weld seam and a second longitudinal weld seam are welded to one another, wherein at least one removal port is arranged in the lower transverse weld seam, wherein the bag is divided into at least a first chamber, a second chamber and a third chamber by a first peel weld seam and a second peel weld seam, wherein the first peel weld seam comprises a first curved tear-open zone and the second peel weld seam comprises a second curved tear-open zone, and wherein the first tear-open zone, starting from the lower transverse weld seam, is arranged higher than the second tear-open zone.

[0020] According to independent claim 1, the invention is described as follows: a bag filled with a medicinal liquid, which is formed from two films that are welded together with a lower transverse weld seam and an upper transverse weld seam and with a first longitudinal weld seam and a second longitudinal weld seam, wherein at least one removal port is arranged in the lower transverse weld seam, wherein the bag is divided by a first peel weld seam and a second peel weld seam into at least a first chamber, a second chamber, and a third chamber, wherein the first peel weld seam comprises a first curved tear-open zone and the second peel weld seam comprises a second curved tear-open zone, wherein the first peel weld seam, starting from the lower transverse weld seam, has a lower rectilinear section that merges into an upper rectilinear section via the first curved tear-open zone,wherein the upper straight section extends over a third curve to the second longitudinal weld seam over a straight region, wherein the second peel weld seam, starting from the lower transverse weld seam, has a first lower straight section which, via the second curved tear-open zone, merges into an upper straight section which ends in the straight region of the first peel weld seam, and wherein the first curved tear-open zone of the first peel weld seam, starting from the lower transverse weld seam, is arranged higher than the second curved tear-open zone of the second peel weld seam. The invention is based on the finding that, when used as intended, the first peel weld seam can be opened up to the lower transverse weld seam via a first peel weld seam, which comprises a curved tear-open zone which, relative to the lower transverse weld seam, is higher than a second tear-open zone of the second peel weld seam.before the second transverse weld begins to tear.

[0021] This makes it easy to use the composition in the third chamber, which only opens when the second peel weld seam is torn open, only optionally.

[0022] The first peel weld seam is designed in particular in such a way that it begins further to the right at the lower transverse weld seam than the second peel weld seam.

[0023] In particular, an inflection point of the first peel weld, starting from the lower transverse weld, is higher than an inflection point of the second peel weld.

[0024] Furthermore, the beginning of the first curved tear zone is preferably located higher than the beginning of the second tear zone. The beginning of a tear zone is defined in particular by a straight section of the first and second peel weld seams transitioning into a curve.

[0025] In one embodiment of the invention, the turning point of the first tear zone of the first peel weld seam is 5 - 150 mm, preferably 10 - 30 mm, particularly preferably 15 - 25 mm, starting from the lower transverse weld seam, higher than the turning point of the second tear zone of the second peel weld seam.

[0026] In a preferred embodiment of the invention, the first curved tear zone and / or the second curved tear zone is formed from a first curvature which merges into a second opposite curvature.

[0027] The first and the second curvature can in particular be designed as a quarter circle and / or as a 90° arc or curvature.

[0028] In a further development of the invention, the first curvature has a smaller inner radius and / or a smaller outer radius than the second curvature.

[0029] In this embodiment of the invention, preferably when the bag is used as intended by rolling from top to bottom, in particular by rolling from top right to bottom left, the force acting on the first or second peel weld seam is highest at the first curve, which is narrower than the second curve, so that the first or second peel weld seam begins to tear open at the first curve.

[0030] The tearing of the first and / or second peel weld seam then continues downwards to the lower transverse weld seam.

[0031] This ensures that the components of the first and second chambers, and optionally the third chamber, are mixed evenly.

[0032] The first peel weld seam is in particular designed such that it has a lower straight section.

[0033] In one embodiment, the lower rectilinear section originates from the lower transverse weld seam and extends upwards, in particular substantially parallel, preferably parallel, to the longitudinal weld seams. The lower rectilinear section then transitions via the first tear zone into an upper rectilinear section. This upper rectilinear section also runs substantially parallel, preferably parallel, to the longitudinal weld seams.

[0034] The upper straight section then runs over a third bend to the second longitudinal weld seam.

[0035] The third bend provides a left-hand bend. The third bend is preferably formed as a 90° bend and / or a quarter circle. After the third bend, the first peel weld runs transversely to the upper straight section of the first peel weld.

[0036] In particular, the first peel weld seam runs after the third bend over a straight line region running essentially parallel, preferably parallel, to the lower transverse weld seam and / or to the upper transverse weld seam up to the second longitudinal weld seam.

[0037] In one embodiment, the second peel weld seam comprises a first lower rectilinear section which runs in particular substantially parallel, preferably parallel, to the longitudinal weld seams.

[0038] The lower straight section starts from the lower transverse weld seam and initially runs upwards to the second tear zone.

[0039] The second tear zone then transitions into an upper, straight section, which ends or opens into the first peel weld seam. The upper, straight section of the second peel weld seam runs essentially parallel, preferably parallel, to the longitudinal weld seams.

[0040] In particular, the second peel weld seam ends or opens in the preferably horizontal, straight region of the first peel weld seam.

[0041] The bag is thus divided into three chambers, with the first chamber extending from the lower cross-weld seam to the upper cross-weld seam and over the second chamber and the third chamber.

[0042] The first chamber is thus particularly angularly shaped, with one leg, particularly the right one, extending from the lower transverse weld seam to the upper transverse weld seam. The other leg extends from the first longitudinal weld seam to the second longitudinal weld seam and thus partially over the second chamber and the third chamber.

[0043] The second chamber and the third chamber preferably extend over one-third to two-thirds of the height of the first chamber.

[0044] Preferably, two, in particular three ports are arranged in the lower transverse weld seam, each of which is connected to one of the three chambers.

[0045] The ports can be used to fill the chambers of the medical bag.

[0046] At least one first port is provided, designed as a withdrawal port. This can comprise a sealing element, in particular a so-called stopper, that can be pierced by a needle or a spike, in order to withdraw the medical fluid and transfer it to the patient, for example, via a transfer system.

[0047] A second port can be designed as an injection port. This also includes a pierceable sealing element, in particular a so-called septum, through which medications or additives can be transferred into the bag, for example, using a syringe.

[0048] Finally, there may also be a third port, preferably designed as a blind port. This serves only to fill one chamber of the bag and is closed with a plug and a cap.

[0049] The withdrawal and / or injection ports are preferably designed as connectors. The connector serves to connect a transfer set to the withdrawal port, for example, by opening the withdrawal port using a spike of the transfer set. A pharmaceutical and / or an additive can be transferred into the bag at the injection port, for example, using a needle syringe. The injection port can also be designed as a threadless Luer connector or as a Luer-Lock connector with a thread, and can be used with a suitable syringe, e.g., a Luer or Luer-Lock syringe.

[0050] The bag is preferably placed in a sterile secondary packaging. In particular, the bag is placed in a tear-open bag.

[0051] According to one embodiment of the invention, the bag is filled with 500-2000 ml of medicinal fluid, in particular with 800-1200 ml, preferably with 900-1100 ml, or with 1300-1700 ml, preferably with 1400-1600 ml of medicinal fluid. For the purposes of the invention, this refers to the total amount of medicinal fluid in the three chambers.

[0052] The bag is preferably designed in such a way that when the bag is rolled up from top to bottom, in particular from top right to bottom left or sideways, the first peel weld seam in the area of ​​the first tear-open zone initially begins to tear open.

[0053] Furthermore, the bag is preferably designed such that when the bag is rolled up from top to bottom, in particular from top right to bottom left, the first peel weld seam tears open as far as the lower transverse weld seam during intended use, in particular with the second peel weld seam only beginning to tear open at the second tear zone thereafter. This allows for the optional use of the third chamber component.

[0054] The right and left sides of the bag are defined, in particular, when the bag is stored with its back on a table. Preferably, the peel seams of the bag are opened by rolling the bag from the top right to the bottom left. In this case, the top side of the bag is defined, in particular, by the position of the hanger and the hanging of the bag from a stand via its hanger.

[0055] In one embodiment of the invention, the bag has a ratio of height h to width b of 0.7 - 1.5, preferably 0.8 - 1.2.

[0056] In particular, in a further embodiment, the bag may have a ratio of h to b of 1.0-1.2 or 0.8-1.0. The first curvature of the first peel weld seam and / or the second peel weld seam may have an inner radius of 2-4 mm and / or an outer radius of 8-12 mm.

[0057] The second curvature of the first peel weld and / or the second peel weld may have an inner radius of 10 - 16 mm and / or an outer radius of 15 - 20 mm.

[0058] As described above, the tear zone of the first peel weld seam and / or the second peel weld seam is more curved at the first bend than at the second, opposite bend. Tearing of the peel weld seam thus preferably begins in the area of ​​the first bend.

[0059] In one embodiment of the invention, the first tear zone has the same course as the second tear zone.

[0060] According to one embodiment of the invention, the first curvature of the first tear zone begins at a distance of 50 - 70 mm from the lower transverse weld seam.

[0061] According to one embodiment of the invention, the first curvature of the second tear zone begins at a distance of 35 - 45 mm from the lower transverse weld seam.

[0062] In one embodiment, the peel weld seams have a width of 5 to 9 mm, in particular 6 to 8 mm.

[0063] The first chamber is preferably filled with a glucose component. The first chamber can contain 0.4–0.7 times, in particular 0.5–0.7 times, the volume of the medicinal liquid. The second chamber is preferably filled with an amino acid component. The second chamber can contain 0.2–0.4 times, in particular 0.35–0.4 times, the volume of the medicinal liquid.

[0064] The third chamber is preferably filled with a fat component, in particular a fat emulsion. The third chamber can contain 0.05–0.15 times, in particular 0.08–0.14 times, the volume of the medicinal liquid.

[0065] Preferably, in addition to the medicinal fluid, the chambers contain a gas volume, particularly an inert gas such as nitrogen. Since the gas volume is compressible, shocks are better absorbed. The likelihood of the bag bursting, for example, if it falls, is reduced. In particular, at least the first, second, and / or third chambers can contain 5-20 ml of gas.

[0066] The films of the bag are preferably formed as multilayer polyolefin films. The films are particularly formed as multilayer polypropylene films.

[0067] At least one layer of the film, in particular all layers of the film, can be designed as a matrix-phase polymer system.

[0068] In a matrix-phase polymer system, at least two different polymers are present, with one polymer being present in a demixed form, in particular as dispersed solidified drops, in the matrix of the other polymer.

[0069] 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 polypropylene. The phase polymer of the matrix-phase polymer system of the inner layer, the middle layer, and the outer layer can each comprise at least one styrene-ethylene / butylene-styrene block copolymer (SEBS) as the phase polymer.

[0070] SEBS is a block polymer composed of styrene, butylene, and ethylene segments, which includes a hydrogenated butadiene segment followed by styrene groups. This polymer 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. The SEBS bonds with the PP matrix polymer.

[0071] Such a multi-layer system can provide highly transparent and at the same time very tear-resistant films by using other components and / or compositions in the respective layers, which can be easily welded into a bag.

[0072] In one embodiment of the invention, the first and / or second peel weld seam is / are designed such that the films of a 30 mm long straight strip separate from each other at a force between 15 and 50 N, preferably between 20 and 30 N.

[0073] A 30 mm wide cutout is cut out along a straight section of the peel weld seam.

[0074] The films are pulled apart on one side of the strip, and the maximum force required to separate the strips is measured using a force gauge. According to one embodiment, the bag does not comprise an inner bag. Preferably, no additional bags, such as small ones, are arranged or inserted into the chambers of the bag. Each of them is free of an inner bag. In particular, the bag comprises exactly three chambers or at least three chambers formed from exactly two films welded together.

[0075] The bag is designed especially for pediatric applications.

[0076] The invention further relates to a method for producing a bag filled with a medicinal liquid, comprising the steps:

[0077] - Providing a first and a second slide;

[0078] - welding the first and second films to form the bag, wherein at least one removal port is welded into a lower transverse weld seam,

[0079] - dividing the bag into three chambers by welding a first peel weld seam with a first curved tear zone and a second peel weld seam with a second curved tear zone, the first tear zone being arranged higher with respect to the lower transverse weld seam than the second tear zone.

[0080] According to independent claim 18, the invention is described by a method for producing a bag filled with a medicinal liquid, comprising the steps:

[0081] - Providing a first and a second slide;

[0082] - Welding the first and second films to form the bag, wherein at least one removal port is welded into a lower transverse weld seam, - Dividing the bag into three chambers by welding a first peel weld seam with a first curved tear-open zone and a second peel weld seam with a second curved tear-open zone, wherein the first peel weld seam, starting from the lower transverse weld seam, has a lower straight section which transitions via the first curved tear-open zone into an upper straight section, wherein the upper straight section runs over a third curve to the second longitudinal weld seam over a straight section, wherein the second peel weld seam, starting from the lower transverse weld seam, has a first lower straight section which transitions via the second curved tear-open zone into an upper straight section which ends in the straight section of the first peel weld seam,and wherein the first curved tear zone of the first peel weld is arranged higher, with respect to the lower transverse weld, than the second tear zone of the second peel weld.

[0083] Preferably, at least a second longitudinal weld seam is welded, wherein the first peel weld seam and / or the second peel weld seam is / are welded after the welding of the lower transverse weld seam and / or after the welding of at least the second longitudinal weld seam.

[0084] In particular, it is provided that the peel welds are welded after the welding of the longitudinal and transverse welds.

[0085] The peel weld seams overlap with the respective longitudinal and transverse weld seams where the respective peel weld seam terminates. This ensures that no weakening zone of the respective transverse or longitudinal weld seam occurs in the overlap area. In the overlap area, only an imprint of the overlapping peel weld seam remains on the transverse or longitudinal weld seam.

[0086] The chambers of the bag are filled with medicinal liquid via one port each after welding the transverse weld seam and the peel weld seams, especially after welding all weld seams.

[0087] At least the lower transverse weld seam and the peel weld seams are preferably welded by means of a contact welding process.

[0088] In such a contact welding process, a welding tool is pressed on, which has a heatable sealing strip that corresponds to the contour of the respective weld seam.

[0089] The contact time and temperature as well as the pressure of the sealing bar on the weld seam can be used to determine whether it is a peel weld seam or a non-tearable longitudinal or transverse weld seam.

[0090] In particular, the material is less liquefied in peel welds, so they are designed to tear open when pressure is applied to the bag. In particular, the bag is rolled up for this purpose. The bag is preferably rolled up from top to bottom. In one embodiment, the bag is rolled up laterally from top right to bottom left.

[0091] After filling and closing the ports, the bag is preferably packed in secondary packaging and stored in the

[0092] Secondary packaging is sterilized. The secondary packaging can be designed, in particular, as a tear-open bag, i.e., a bag with welded films.

[0093] Preferably, the films of the tear-open bag comprise an oxygen barrier layer, in particular a metal or metal oxide layer.

[0094] Sterilization of the bag packed in the secondary packaging is preferably carried out by autoclaving.

[0095] Brief description of the drawings

[0096] The subject matter of the invention will be explained in more detail below with reference to exemplary embodiments based on the drawings Fig. 1 to Fig. 4.

[0097] Fig. 1 shows an embodiment of a bag according to the invention filled with a medical liquid.

[0098] Fig. la is a detailed view of a tear zone.

[0099] Fig. 2 shows the bag arranged in a secondary packaging.

[0100] Fig. 3 shows another embodiment of a bag filled with a medical liquid.

[0101] Fig. 4 is a flowchart of an embodiment of the method for manufacturing a medical bag according to the invention. Detailed Description of the Drawings

[0102] Fig. 1 shows an embodiment of a bag 10 filled with a medicinal liquid. The bag 10 is shown in an unfilled state. Information regarding dimensions and the course of the weld seams refers, by definition, to the unfilled bag 10.

[0103] The bag 10 is formed from two films welded together.

[0104] The films are welded together via a lower transverse weld seam 11a, an upper transverse weld seam 11b as well as a first longitudinal weld seam 12a, shown here on the right, and a second longitudinal weld seam 12b, shown here on the left.

[0105] The bag 10 is rectangular.

[0106] Located in the upper transverse weld seam 11b is a hanger 13 for attaching or hanging the bag 10 on a rack or stand. The hanger 13 is designed here as an arcuate notch. Furthermore, a cutout is arranged above the hanger 13, which serves as a handle 16 for carrying the bag 10.

[0107] In the area of ​​the hanger 13 and the handle, the upper transverse weld seam 11b widens.

[0108] The bag 10 is divided into a first chamber 16a, a second chamber 16b, and a third chamber 16c by a first peel weld seam 14, located here on the right, and a second peel weld seam 15, located here on the left. According to this exemplary embodiment, the bag 10 is filled with a total of 800-1200 ml, preferably 900-1100 ml, of a medicinal liquid.

[0109] The first chamber 16a is preferably filled with a glucose solution. The second chamber 16b is preferably filled with an amino acid-containing solution. The third chamber 16c is preferably filled with a fat emulsion.

[0110] The first chamber 16a is preferably filled with 550 - 630 ml. The second chamber 16b is preferably filled with 300 - 350 ml. The third chamber 16c is preferably filled with 85 - 130 ml. The second chamber 16b and / or the third chamber 16c preferably has / have a height of 155 - 175 mm (measured between the lower transverse weld seam 11a and the section 14e). Preferably, the first chamber 16a above the third chamber 16c has a height of 110 - 130 mm (measured between the section 14f and the straight region of the upper transverse weld seam 11b).

[0111] The first chamber 16a has a width of preferably 50-70 mm (measured between section 14a and the right longitudinal weld seam 12a) in the lower rectilinear section 14a. The second chamber 16b has a width of preferably 145-165 mm (measured between section 14a and section 15a) in the lower rectilinear section 14a / 15a. The third chamber 16c has a width of preferably 80-100 mm (measured between section 15a and the left longitudinal weld seam 12b) in the lower rectilinear section 15a.

[0112] Three ports 20a - 20c are arranged in the lower transverse weld seam 11a.

[0113] The ports 20a - 20c are each closed with an upper part 23, which is placed on a lower part 21. Between the lower part 21 and the upper part 23 there is a seal (not shown).

[0114] Port 20a is connected to the first chamber 16a and is designed as a withdrawal port 20a. Port 20b is designed as an injection port 20b.

[0115] The withdrawal port 20a and the injection port 20b comprise an upper part 23 provided with a break-off cap 24. After breaking off the break-off cap 24, the seal can be pierced with a spike or needle to withdraw liquid from the bag or to dose it into the bag.

[0116] Port 20c is designed as a blind port and serves only to fill the third chamber 16c. Accordingly, it is closed only by an upper part 23 designed as a cap, with a seal also arranged between the cap and the lower part 21 of port 20c.

[0117] The lower part 21 comprises a welding section 22 with which the respective port 20a to 20c is welded into the lower transverse weld seam 11a.

[0118] The ports 20a - 20c are preferably spaced apart from each other by 90 to 130 mm, in particular 90 to 110 mm (center port to center port).

[0119] The ratio of height h to width b of the bag 10 in this embodiment is 0.85-1.0. Preferably, the bag 10 has a width b of b = 310-350 mm and / or a length or height h of h = 285-330 mm. The bag 10 is divided into three chambers 16a-16c by a first peel weld seam 14 and a second peel weld seam 15.

[0120] The first peel weld seam 14 begins at the lower transverse weld seam 11a between the ports 20a and 20b, runs upwards and then to the second longitudinal weld seam 12b.

[0121] Accordingly, the first chamber 16a extends to the right of the lower transverse weld seam 11a to the upper transverse weld seam 11b and extends adjacently over the second chamber 16b and third chamber 16c to the second longitudinal weld seam 12b. The first chamber 16a is thus formed as an angle.

[0122] The first peel weld seam 14 begins with a lower straight section 14a, which preferably runs parallel to the longitudinal weld seams 12a, 12b. This is followed by the first curved tear zone A1.

[0123] The tear zone A1 is formed by a first curve 14b, which transitions into a second, opposite curve 14c. The curve 14b is narrower than the curve 14c.

[0124] The first peel weld seam 14 therefore makes an approximately S-shaped offset at the first tear zone Al in the direction of the second peel weld seam 15.

[0125] Starting from the first tear zone A1, an upper, straight-line region 14d extends upwards, which also preferably runs parallel to the longitudinal weld seams 12a, 12b. The first peel weld seam 14 then transitions via a third bend 14e into a horizontal, straight section 14f, which extends to the second longitudinal weld seam 12b.

[0126] The second peel weld seam 15 is located between the port 20b and the port 20c and starts at the lower transverse weld seam 11a.

[0127] The second peel weld seam 15 also comprises a lower straight section 15a, which transitions into an upper straight section 15d via the second curved tear zone A2. The lower straight section 15a and the upper straight section 15d preferably run parallel to the longitudinal weld seams 12a, 12b.

[0128] The upper straight section 15d runs up to the horizontal straight section 14f of the first peel weld 14.

[0129] Starting from the intersection point of the first peel weld seam 14 with the second peel weld seam 15, a part of the horizontal straight section 14f of the first peel weld seam 14 thus serves to close the third chamber 16c.

[0130] It is understood that, by definition, this area could also be formed as part of the second peel weld seam 15. The first peel weld seam 14 and the second peel weld seam 15 can, in particular, also be formed with a single welding tool, the sealing strips of which are arranged according to the arrangement of the peel weld seams 14, 15.

[0131] Due to the opposing curvatures 14b, 14c, 15b, 15c, the first tear zone A1 comprises an inflection point W1, and the second tear zone A2 comprises an inflection point W2. According to the invention, the inflection point W1 of the first curved tear zone A1 is higher than the inflection point W2 of the second tear zone A2, relative to the lower transverse weld seam 11a.

[0132] Preferably, the vertices of the curvatures 14b and 14c of the first peel weld seam 14 are also higher than the respective vertices of the curvatures 15b and 15c of the second peel weld seam 15.

[0133] Due to the illustrated configuration of the peel weld seams 14, 15, when the bag 10 is rolled from top to bottom, in particular from top right to bottom left, the first peel weld seam 14 opens in the area of ​​the curved tear zone A1.

[0134] The first peel weld seam then opens downwards to the lower transverse weld seam 11a. The first peel weld seam 14 can also tear open further upwards. At least if the first chamber 16c is not to be opened, the first peel weld seam 14 does not need to tear open beyond the third bend 14e. What is crucial is that the first chamber 16a, adjacent to the lower transverse weld seam 11a, is now connected to the second chamber 16b.

[0135] As the bag 10 is further rolled up, the second peel weld seam 15 opens in the area of ​​the second tear-open zone A2. Starting from the tear-open zone A2, the second peel weld seam 15 opens at least downwards to the lower transverse weld seam 11a, so that the third chamber 16c is then also connected to the remaining bag volume.

[0136] Fig. 1a is a detailed view of the tear zones A1 and A2. The first bend 14b / 15b and the second bend 14c / 15c each have an inner radius r± and an outer radius r a The first bend 14b / 15b has an inner radius of 2 to 4 mm and an outer radius of 8 to 12 mm. The second bend 14c / 15c has an inner radius of 10 to 16 mm and an outer radius of 15 to 20 mm.

[0137] As illustrated with reference to Fig. 2, the bag 10 is packaged in a secondary packaging, preferably equipped with an oxygen barrier. The secondary packaging is designed here as a tear-open bag 30 made of two films welded together.

[0138] A longitudinal weld seam of the tear-open bag 30 has a notch 31 on the edge to facilitate tearing open the tear-open bag 30.

[0139] Fig. 3 shows an alternative embodiment of a bag 10 filled with a medical liquid.

[0140] In contrast to the example shown in Fig. 1, the present bag 10 is higher, ie the distances between the ports 20a - 20c and the peel weld seams 14, 15 correspond to the embodiment according to Fig. 1.

[0141] The ratio of height h to width b in this embodiment is 1.05 - 1.2. Preferably, the bag 10 has a width b of b = 310 - 350 mm and / or a length or height h of h = 345 - 390 mm.

[0142] The bag shown in Fig. 3 is filled with a total of 1300 - 1700 ml, preferably 1400 - 1600 ml, of liquid.

[0143] The first chamber 16a is preferably filled with a glucose solution. The second chamber 16b is preferably filled with an amino acid-containing solution. The third chamber 16c is preferably filled with a fat emulsion. The first chamber 16a is preferably filled with 840 - 920 ml. The second

[0144] Chamber 16b is preferably filled with 450–525 ml. The third chamber 16c is preferably filled with 140–190 ml.

[0145] Preferably, the second chamber 16b and / or the third chamber 16c has / have a height of 210-230 mm (measured between the lower transverse weld seam 11a and the section 14e). Preferably, the first chamber 16a above the third chamber 16c has a height of 110-140 mm (measured between the section 14f and the straight area of ​​the upper transverse weld seam 11b).

[0146] The first chamber 16a has a width of preferably 50-70 mm in the lower rectilinear section 14a. The second chamber 16b has a width of preferably 145-165 mm in the lower rectilinear section 14a / 15a. The third chamber 16c has a width of preferably 80-100 mm in the lower rectilinear section 15a.

[0147] The first chamber 16a has a width of preferably 50-70 mm (measured between section 14a and the right longitudinal weld seam 12a) in the lower rectilinear section 14a. The second chamber 16b has a width of preferably 145-165 mm (measured between section 14a and section 15a) in the lower rectilinear section 14a / 15a. The third chamber 16c has a width of preferably 80-100 mm (measured between section 15a and the left longitudinal weld seam 12b) in the lower rectilinear section 15a.

[0148] With reference to Fig. 3, the determination of the tear force of the peel weld seams 14, 15 will be further explained.

[0149] First, using the peel weld seam 14 as an example, a 30 mm wide section 40 is cut out of the two films along a straight section of the peel weld seam 14. On one side of the strip-shaped section 40, the films are pulled apart parallel to the peel weld seam 14, and the maximum force required to separate the film strips is measured using a force measuring device. This maximum force corresponds to the tearing force.

[0150] Fig. 4 is a flowchart of an embodiment of the method 100 according to the invention for producing a medical bag 10.

[0151] A first and a second film are provided (step 101). The films are preferably formed as multilayer polyolefin films.

[0152] The films are then welded to the bag 10 by means of a contact welding process, wherein at least one removal port 20a is welded into a lower transverse weld seam 11a (step 102).

[0153] The bag is then sealed into the three chambers 16a-16c by welding a first peel weld seam 14 and a second peel weld seam 15 (step 103). The peel weld seams 14, 15 are thus made after the longitudinal and transverse weld seams 11a, 11b, 12a, 12b have been welded.

[0154] The course of the peel weld seams 14, 15 corresponds to the representation according to Fig. 1 or Fig. 3.

[0155] The bag is then packaged in a tear-open bag 30, preferably sealed, (step 104) and autoclaved 105 together with the tear-open bag 30. The invention makes it possible to provide a medical bag which is particularly suitable for pediatric applications.

[0156] Reference symbol list

[0157] 10 bags

[0158] 11a lower transverse weld seam

[0159] 11b upper transverse weld

[0160] 12a first longitudinal weld

[0161] 12b second longitudinal weld

[0162] 13 trailers

[0163] 14 first peel weld

[0164] 14a lower straight area or section

[0165] 14b first bend

[0166] 14 c second bend

[0167] 14d upper straight area or section

[0168] 14e third curvature

[0169] 14 f horizontal straight section

[0170] 15 second peel weld

[0171] 15a lower straight area or section

[0172] 15b first bend

[0173] 15c second bend

[0174] 15d upper straight section

[0175] 16a first chamber

[0176] 16b second chamber

[0177] 16c third chamber

[0178] 20a port / withdrawal port

[0179] 20b Port / Injection port

[0180] 20c port / blind port

[0181] 21 Lower part

[0182] 22 Welding section

[0183] 23 Top

[0184] 24 Break-off cap

[0185] 30 On zipper bag 31 Notch

[0186] 40 Excerpt

[0187] 100 Methods for manufacturing a medical bag

[0188] 101 Providing a first and a second film 102 Welding the first and the second film to the

[0189] Bag (10), wherein at least one removal port (20a) is welded into a lower transverse weld seam (11a)

[0190] 103 Dividing the bag (10) into three chambers (16a- 16c) by welding a first peel weld seam

[0191] (14) and a second peel weld seam (15)

[0192] 104 Sealing the bag (10) in a tear-open bag (30)

[0193] 105 Autoclaving the bag (10) arranged in the tear-open bag (30)

Claims

Claims:

1. Bag (10) filled with a medicinal liquid, which is formed from two films which are provided with a lower transverse weld seam (11a) and an upper transverse weld seam (11b) and with a first Longitudinal weld seam (12a) and a second longitudinal weld seam (12b) are welded together, wherein at least one removal port (20a) is arranged in the lower transverse weld seam (11a), wherein the bag (19) is divided by a first peel weld seam (14) and a second peel weld seam (15) into at least a first chamber (16a), a second chamber (16b) and a third chamber (16c), wherein the first peel weld seam (14) comprises a first curved tear-open zone (A1) and the second peel weld seam (15) comprises a second curved tear-open zone (A2), wherein the first peel weld seam (14), starting from the lower transverse weld seam (11a), has a lower rectilinear section (14a) which merges via the first curved tear-open zone (A1) into an upper rectilinear section (14d), wherein the upper straight section (14d) extends over a third bend (14e) to the second longitudinal weld seam (12b) over a straight area (14f), wherein the second peel weld seam (15),starting from the lower transverse weld seam (11a), has a first lower straight section (15a) which merges via the second curved tear zone (A2) into an upper straight section (15d) which ends in the straight region (14f) of the first peel weld seam (14), and wherein the first curved tear zone (A1) of the first, Peel weld seam (14) , starting from the lower Transverse weld (11a) , higher than the second curved Tear zone (A2) of the second peel weld seam (15).

2. Bag filled with a medicinal liquid according to the preceding claim, characterized in that an inflection point (Wl) of the first tear-open zone (A1) of the first peel weld seam (14), starting from the lower transverse weld seam (11a), is higher than an inflection point (W2) of the second tear-open zone (A2) of the second peel weld seam (15).

3. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the first curved tear-open zone (A1) and / or the second curved tear-open zone (A2) is / are formed from a first curvature (14b, 15b) and a second, opposite curvature (14c, 15c), wherein the first curvature (14b, 15b) merges into the second opposite curvature.

4. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the first curvature (14b, 15b) and the second curvature (14c, 15c) are formed substantially as 90° curvatures.

5. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the first curvature (14b, 15b) has a smaller inner radius and / or a smaller outer radius than the second curvature (14c, 15c).

6. Bag (10) filled with a medicinal liquid according to one of the preceding claims, characterized characterized in that the upper straight section (14d) of the first peel weld seam (14) extends over the third curvature (14e) to the second longitudinal weld seam (12b) via a straight region (14f) running substantially parallel to the lower transverse weld seam (11a).

7. Bag (10) filled with a medicinal liquid according to one of the preceding claims, characterized in that the upper straight section (15d) of the second peel weld seam (15) ends in the horizontal straight region (14f) of the first peel weld seam.

8. Bag (10) filled with a medicinal liquid according to one of the preceding claims, characterized in that the first chamber (16a) extends from the lower transverse weld seam (11a) to the upper transverse weld seam (11b) and over the second chamber (16b) and the third chamber (16c).

9. Bag (10) filled with a medicinal liquid according to one of the preceding claims, characterized in that the second chamber (16b) and the third chamber (16c) extend over 1 / 3 to 2 / 3 of the height of the first chamber (16a).

10. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that two, in particular three, ports (20a-20c) are arranged in the lower transverse weld seam (11a), each of which is connected to one of the three chambers (16a-16c).

11. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the bag (10) is arranged in a sterile manner in a secondary packaging, in particular in a tear-open bag (30).

12. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the bag (10) is filled with 500 to 2000 ml of medical liquid, in particular with 800 to 1200 ml or with 1300 to 1700 ml of medical liquid.

13. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the bag (10) is designed such that when the bag (10) is rolled up from top to bottom, in particular from top right to bottom left, the first peel weld seam (14) begins to tear open in the region of the first tear-open zone (Al).

14. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the bag (10) is designed such that when the bag (10) is rolled up from top to bottom, in particular from top right to bottom left, the first peel weld seam (14) tears open at least as far as the lower transverse weld seam (11a), after which the second peel weld seam (15) begins to tear open at the second tear zone (A2).

15. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the first chamber (16a), in particular the one with a glucose component filled chamber contains 0.4 to 0.7 times, in particular 0.5 to 0.7 times, the volume of the medicinal liquid, and / or that the second chamber (16b), in particular the chamber filled with an amino acid component, contains 0.2 to 0.4 times, in particular 0.35 to 0.4 times, the volume of the medicinal liquid, and / or that the third chamber (16c), in particular the chamber filled with a fat component, contains 0.05 to 0.15 times, in particular 0.08 to 0.14 times, the volume of the medicinal liquid.

16. Bag (10) filled with a medicinal liquid according to one of the preceding claims, characterized in that the first and / or the second peel weld seam (14, 15) is or are designed such that the films of a 30 mm wide rectilinear strip separate from one another at a force between 15 and 50 N, preferably between 20 and 30 N.

17. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the bag (10) is designed for applications in pediatrics.

18. A method for producing a bag (10) filled with a medicinal liquid, comprising the steps of: - Providing a first and a second slide; - welding the first and the second film to form the bag (10), wherein at least one removal port (20a) is welded into a lower transverse weld seam (11a), - dividing the bag (19) into three chambers (16a-16c) by welding a first peel weld seam (14) with a first curved tear zone (Al) and a second peel weld seam (15) with a second curved Tear-open zone (A2), wherein the first peel weld seam (14), starting from the lower transverse weld seam (11a), has a lower straight section (14a), which merges via the first curved tear-open zone (A1) into an upper straight section (14d), wherein the upper straight section (14d) runs via a third curve (14e) to the second longitudinal weld seam (12b) via a straight region (14f), wherein the second peel weld seam (15), starting from the lower transverse weld seam (11a), has a first lower straight section (15a), which merges via the second curved tear-open zone (A2) into an upper straight section (15d), which ends in the straight region (14f) of the first peel weld seam (14), and wherein the first curved tear zone (Al) of the first peel weld seam (14) is arranged higher, with respect to the lower transverse weld seam (11a), than the second tear zone (A2) of the second peel weld seam (15).

19. Method according to the preceding claim, characterized in that the first peel weld seam (14) and / or the second peel weld seam (15) is / are welded after the welding of the lower transverse weld seam (11a) and the welding of at least one second longitudinal weld seam (12b) and / or that the chambers (16a-16c) of the bag (10) are filled with a medicinal liquid via a respective port (20a-20c) after the welding of the transverse weld seam (11a) and the peel weld seams (14, 15).

20. Method according to one of the preceding claims, characterized in that at least the lower transverse weld seam (11a) and the peel weld seams (14, 15) are welded by means of a contact welding process and / or that the bag (10) is packaged in a secondary packaging, in particular a tear-open bag (30), and is sterilized in the secondary packaging.

Images