Bag which is filled with a medical fluid and has curved tear zones, 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. The bag is 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 three chambers by a first peel seam and a second peel seam. The first peel seam extends from the bottom cross-seam to the top cross-seam. The second peel seam extends from the bottom cross-seam to the second longitudinal seam.

Description

[0001] MEDICINAL LIQUID-FILLED BAG WITH CURVED TEAR ZONES AND METHOD FOR THE PRODUCTION THEREOF

[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 parenteral nutrition 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, preferably laterally, 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 is referred to therein as the so-called tear zone and which supports the tearing of the peel weld seams.

[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 accidental tearing of the peel seals during transport, thus opening the chambers. On the other hand, the peel seals should be designed in such a way that the user does not have to exert excessive force to exert sufficient pressure when rolling the bag 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 generally smaller, usually less than 1000 ml.

[0012] When the bag 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 adequate mixing of the various components of the nutritional composition. This is especially important for pediatric applications, as the contents of the bag 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, which has improved tear-open properties of the peel weld seams, in particular for smaller volumes, for example for pediatric applications, of less than 1000 ml or less than 750 ml.

[0015] Summary of the invention

[0016] The object of the invention is already achieved by a bag filled with a medical liquid and by a method for producing a bag filled with a medical 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 bag is formed from two films which are welded to one another 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 into three chambers by a first peel weld seam and a second peel weld seam, wherein the first peel weld seam extends from the lower transverse weld seam to the upper transverse weld seam, and wherein the second peel weld seam extends from the lower transverse weld seam to the second longitudinal weld seam. For example, a first chamber, a second chamber and a third chamber are thereby formed in the bag. The bag is designed here as a bag with exactly three or at least three chambers.

[0019] According to independent claim 1, the invention is described by a bag filled with a medicinal liquid, which is formed from two films which 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 first peel weld seam extends from the lower transverse weld seam to the upper transverse weld seam, wherein the second peel weld seam extends from the lower transverse weld seam to the second longitudinal weld seam, and wherein the bag is divided into three chambers by a first peel weld seam and a second peel weld seam, and wherein at least three ports are arranged in the lower transverse weld seam, each of which is connected to one of the three chambers.

[0020] A first outer chamber, particularly arranged on the right here, extends from the lower transverse weld seam to the upper transverse weld seam. In contrast to the aforementioned prior art for three-chamber bags, the first chamber, particularly arranged on the right here, does not extend across the entire width of the medical bag. The second chamber, in the middle here, extends from the lower transverse weld seam to the upper transverse weld seam.

[0021] The third chamber, specifically the one on the left here, which is filled with a fat emulsion, borders only two sides of the outer edge of the bag and is thus located in a corner area within a central chamber. The third chamber is delimited by the second peel seal, the lower transverse seal, and the longitudinal seal, shown here on the left.

[0022] It has been shown that such a configuration of the peel welds results in a significantly improved

[0023] Tear resistance is ensured, especially for smaller bags.

[0024] 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 also defined, in particular, by the position of the hanger and the hanging of the bag from a stand via its hanger.

[0025] In particular, when the bag is rolled, the first peel weld seam opens, which runs from the lower cross weld seam to the upper cross weld seam or which runs between the lower cross weld seam and the upper cross weld seam.

[0026] As the bag is further rolled up, the second peel-weld seam opens, revealing the chamber, which is preferably filled with a lipid emulsion. This tear-open action allows the user to use the third chamber of the bag only optionally. Especially in pediatric applications, the addition of a lipid component is sometimes omitted.

[0027] The terms "longitudinal weld seam" and "transverse weld seam" serve to differentiate between the two within the meaning of the invention. By definition, the lower cross-sectional seam forms the lower edge or side of the bag when used as intended, ie when the bag is used with a port facing downwards for administering the medical fluid. The longitudinal weld seams therefore do not necessarily have to be longer than the transverse weld seams. However, the medical bag preferably has a height h which is greater than its width b.

[0028] In a preferred embodiment of the invention, the second peel weld seam runs over a first curvature in the direction of the second longitudinal weld seam.

[0029] The second peel weld seam changes direction via the curve and ends at the second longitudinal weld seam or merges into it.

[0030] The first bend of the second peel weld seam provides a left-hand curve. The first bend of the second peel weld seam preferably extends at approximately 90° and can, for example, be formed as a quarter circle.

[0031] According to a development of the invention, the second peel weld seam merges into the second longitudinal weld seam via a second curvature, which runs in particular in the direction of the upper transverse weld seam. In this embodiment, the second peel weld seam therefore does not end at a right angle in the second longitudinal weld seam, but rather makes a curve, preferably an upward curve, and then ends in the second longitudinal weld seam. This second curvature can, for example, be designed as a segment of a circle. It is provided in particular that the second curvature of the second peel weld seam has an apex which, based on the width of the bag, is arranged between the second longitudinal weld seam and the first curvature of the second peel weld seam.

[0032] In the overlap area of ​​the second longitudinal weld and the second peel weld, these welds preferably run at an acute angle relative to their center, preferably at an angle of less than 70°, in particular at an angle of 0° to 50°. Thus, a tangent following the center of the second peel weld in the overlap area is at an angle of less than 70°.

[0033] By running the second peel weld seam in a curve, pressure peaks in this area are avoided.

[0034] This ensures in particular that the second peel weld seam, when used as intended, first tears open below the first bend and then opens up to the lower transverse weld seam.

[0035] In a preferred embodiment of the invention, the first peel weld initially runs along a first, lower curve toward the second peel weld and then returns along a second, upper curve toward the upper transverse weld. The first peel weld thus has a lateral offset. In particular, the first peel weld has an S-shaped region formed by the two curves.

[0036] This allows the volume of the first chamber, which is filled in particular with a glucose-containing solution, to be increased compared to the other chambers.

[0037] Furthermore, this design ensures that when the bag is rolled up from above, in particular from the top right, downwards, in particular to the bottom left, the first peel weld seam opens in an area between the first curvature and the lower transverse weld seam and then tears open downwards to the lower transverse weld seam.

[0038] In contrast to the prior art mentioned above, the S-shaped curve formed by the two curves preferably does not serve as the initial tear zone. Rather, the initial tear zone, where tearing begins, is located below it. In particular, the initial tear zone is located essentially centrally in the lower straight section.

[0039] In a further development of the invention, the apex of the first curvature of the first peel weld seam, starting from the upper transverse weld seam, is positioned lower than the apex of the first curvature of the second peel weld seam. The first curvatures of the two peel weld seams are thus offset in height relative to the longitudinal weld seams.

[0040] This arrangement also improves the tearing behavior in that the first peel weld seam begins to tear below the first bend and then tears up to the lower transverse weld seam.

[0041] In a preferred embodiment of the invention, at least two, preferably three ports are arranged in the first transverse weld seam, each of which is connected to one of the three chambers.

[0042] The ports can be used to fill the chambers of the medical bag.

[0043] 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.

[0044] 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 and / or additives can be transferred into the bag, for example, using a syringe.

[0045] 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.

[0046] The withdrawal and / or injection port are preferably designed as connectors. The connector on the withdrawal port is used to connect a transfer set, for example by opening or piercing the withdrawal port using a spike on the transfer set. A pharmaceutical or an additive can be transferred into the bag at the injection port 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 each be used with a suitable syringe, e.g. a Luer or a Luer-Lock syringe. According to one embodiment, the first peel weld seam comprises, from bottom to top, a lower straight section, a first bend in the direction of the second peel weld seam, a second bend in the direction of the upper transverse weld seam and an adjoining upper straight section.

[0047] In one embodiment, the lower straight section and / or the upper straight section runs or runs substantially parallel, preferably parallel, to the longitudinal weld seams.

[0048] The first peel weld runs from bottom to top, exhibiting a lateral offset along an S-shaped curve. Viewed from below, the lateral offset runs in the direction of the second peel weld or the second longitudinal weld.

[0049] According to one embodiment, the second peel weld seam comprises a lower straight section which merges via the first curvature of the first peel weld seam into a region running transversely in the direction of the second longitudinal weld seam.

[0050] In one embodiment, the first rectilinear region runs substantially parallel, preferably parallel, to the longitudinal weld seams.

[0051] The first curvature of the second peel weld seam is preferably formed substantially as a 90° curve.

[0052] Thus, the region running transversely in the direction of the second longitudinal weld seam can, at least in sections, run essentially parallel, preferably parallel, to the transverse weld seams. According to another embodiment, there is no straight-line region between the first curvature and the second curvature, in particular, the first curvature merges directly into the second curvature of the second peel weld seam.

[0053] The first peel seal and the second peel seal divide the bag into a right-hand first chamber, a middle second chamber, and a left-hand third chamber. The first chamber is specifically the outer right chamber. The third chamber is specifically the outer left chamber. The second chamber is located in a lower section centrally between the first chamber and the third chamber. An upper section of the second chamber forms an outer chamber section.

[0054] The right first chamber extends in the upper area only over the middle second chamber, but not over the third left chamber.

[0055] The second chamber extends over the third left chamber in the upper area.

[0056] The bag is preferably placed in a sterile secondary packaging. In particular, the bag is placed in a tear-open bag.

[0057] According to a preferred embodiment of the invention, the bag is filled with 200 - 600 ml of medical liquid, in particular with 200 - 300 ml or with 400 - 600 ml of medical liquid.

[0058] For the purposes of the invention, this refers to the total amount of medical fluid in the three chambers. Preferably, in addition to the medical fluid, the chambers contain a gas volume, in particular an inert gas such as nitrogen. Since the gas volume is compressible, shocks are better absorbed and the likelihood of the bag bursting, for example, if it is dropped, is minimized. In particular, at least the first and / or second chamber can contain 5-20 ml of gas. The third chamber can contain less gas volume than the first or second chamber, in particular less than 5 ml of gas.

[0059] The bag is preferably designed in such a way that when the bag is rolled up, in particular laterally, from top to bottom, the first peel weld seam begins to tear open in an area between the first curvature and the lower transverse weld seam.

[0060] The tearing then preferably occurs upwards and downwards. In particular, when used as intended, the first peel weld seam opens up to the lower transverse weld seam. An upper area adjacent to the upper transverse weld seam may, but does not have to, open. The chambers are then connected to each other at least in their lower areas, allowing the components of the first and second chambers to mix well.

[0061] The second peel seal also begins to tear when the bag is rolled up in an area between the first bend and the lower cross seal.

[0062] Here, the tearing occurs primarily downwards and upwards, preferably until the second peel weld seam has torn open all the way to the lower transverse weld seam during intended use. The second peel weld seam does not have to open all the way to the upper transverse weld seam. This tearing behavior, in particular, enables the optional use of the third chamber.

[0063] Preferably, the bag has a height to width ratio, h to b, of 1.05 - 1.8, particularly preferably 1.1 - 1.6. This ratio is particularly suitable for small volumes.

[0064] According to one embodiment, the vertices of the first curvature of the first peel weld seam and the first curvature of the second peel weld seam are spaced apart by at least 3 mm, preferably 3 - 50 mm, in particular 5 - 30 mm in height (along the longitudinal weld seam).

[0065] In one embodiment of the invention, the second bend of the second peel weld seam has a radius of 10-20 mm. The first and / or second bend of the first peel weld seam can have a radius of 20-40 mm. By definition, the radius is the outer radius of the bend.

[0066] The first chamber preferably has the largest volume of liquid.

[0067] According to one embodiment, the first chamber, in particular the chamber filled with a glucose component, has 0.4 - 0.7 times, in particular 0.5 - 0.6 times, the total volume of the medicinal liquid.

[0068] The second chamber, in particular the middle chamber, is preferably filled with an amino acid component and has 0.3-0.6 times, in particular 0.35-0.5 times, the volume of the medicinal liquid. The third chamber, in particular the left chamber, which is preferably filled with a fat component, preferably a fat emulsion, contains, according to one embodiment, 0.05-0.15 times, in particular 0.08-0.14 times, the volume of the medicinal liquid.

[0069] The peel weld seams preferably have a width of 2 - 4 mm, particularly preferably 2.5 to 3.5 mm.

[0070] The vertices of the first curvature of the first peel weld seam and / or the first curvature of the second peel weld seam are preferably arranged in a range of 1 / 3 - 2 / 3 of the height of the bag.

[0071] According to one embodiment, the first peel weld seam ends approximately centrally in the upper transverse weld seam.

[0072] The first peel weld seam can, in particular, end in an area of ​​the second transverse weld seam in which a hanger for hanging the bag is located. This can, in particular, be an incision or a through hole.

[0073] The first curvature and / or the second curvature of the first peel weld seam can each be formed as an eighth of a circle. The first curvature of the second peel weld seam is preferably formed as a quarter circle.

[0074] The first curvature and / or the second curvature of the first peel weld seam run in a transition region, in particular at an inflection point, preferably obliquely but not perpendicularly to the longitudinal weld seams, in particular at an angle of 30-60°. The films are preferably formed as multilayer polyolefin films. The films are in particular formed as multilayer polypropylene films.

[0075] At least one layer of the film, in particular all layers of the film, can be designed as a matrix-phase polymer system.

[0076] 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.

[0077] 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.

[0078] The phase polymer of the matrix-phase polymer system of the inner layer, the middle layer and the outer layer may each comprise at least one styrene-ethylene / butylene-styrene block copolymer (SEBS) as a phase polymer.

[0079] 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.

[0080] 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.

[0081] According to one embodiment, the first and second peel weld seams are designed such that the films of a 30 mm long straight strip separate from each other at a force between 10 and 30 N, preferably between 15 and 25 N, particularly preferably between 17.2 and 22 N.

[0082] A 30 mm wide cutout is cut out along a straight section of the peel weld seam.

[0083] 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 measuring device.

[0084] According to one embodiment, the bag does not comprise an inner bag. 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, which are formed from exactly two films welded together.

[0085] The bag is designed especially for pediatric applications.

[0086] The invention further relates to a method for producing a bag filled with a medicinal liquid, comprising the steps:

[0087] - Providing a first and a second slide;

[0088] - Welding the first and the second film to form the bag, wherein in a lower transverse weld seam at least one

[0089] - Dividing the bag into three chambers by welding a first peel weld and a second

[0090] Peel weld seam, and wherein the first peel weld seam is welded in such a way that it runs from the lower transverse weld seam to an opposite side of the bag, wherein the second peel weld seam is welded in such a way that it initially runs upwards from the lower transverse weld seam and then changes direction via a curve and ends on a long side of the bag.

[0091] According to independent claim 18, the invention is described by a method for producing a bag filled with a medicinal liquid, comprising the steps:

[0092] - Providing a first and a second slide;

[0093] - welding the first and second films to form the bag, wherein at least one removal port is welded into a lower transverse weld seam,

[0094] - Dividing the bag into three chambers by welding a first peel weld and a second

[0095] Peel weld seam, and wherein the first peel weld seam is welded in such a way that it runs from the lower transverse weld seam to an opposite side of the bag, wherein the second peel weld seam is welded in such a way that it initially runs upwards from the lower transverse weld seam and then changes direction via a curve and ends on a long side of the bag, wherein at least three ports are arranged in the lower transverse weld seam, which ports are each connected to one of the three chambers, and wherein the three chambers of the bag are each filled with a medicinal liquid via a port. Preferably, at least one 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.

[0096] In particular, it is provided that the peel welds are welded after the welding of the longitudinal and transverse welds.

[0097] The peel welds overlap with the respective longitudinal and transverse welds where the peel weld ends. This ensures that no weakening zone of the respective transverse or longitudinal weld is created in the overlap area.

[0098] In the overlap area, there is only an imprint of the overlapping peel weld on the transverse or longitudinal weld seam.

[0099] 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.

[0100] At least the lower transverse weld seam and the peel weld seams are preferably welded by means of a contact welding process.

[0101] In this type of contact welding process, a welding tool is pressed onto the weld, which has a heatable sealing bar that conforms to the contour of the respective weld. The contact time and temperature, as well as the pressure of the sealing bar on the weld, can be used to determine whether the weld is a peel weld, a longitudinal weld, or a transverse weld.

[0102] 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.

[0103] After filling and closing the ports, the bag is preferably packaged in secondary packaging and sterilized in the secondary packaging. The secondary packaging can, in particular, be designed as a tear-open bag, i.e., a bag with welded films.

[0104] Preferably, the films of the tear-open bag comprise an oxygen barrier layer, in particular a metal or metal oxide layer.

[0105] Sterilization of the bag packed in the secondary packaging is preferably carried out by autoclaving.

[0106] Brief description of the drawings

[0107] The subject matter of the invention will be explained in more detail below with reference to the drawings Fig. 1 to Fig. 5.

[0108] Fig. 1 shows an embodiment of a bag filled with a medicinal liquid. Fig. 1a is a detailed view of the second peel weld seam in the area of ​​the transition to the longitudinal weld seam.

[0109] Fig. 2 shows the arranged in a secondary packaging

[0110] Bag from Fig. 1 (with caps attached).

[0111] Fig. 3 shows another embodiment of a bag filled with a medical liquid.

[0112] Fig. 4 shows the bag from Fig. 3 to illustrate the measurement of the tear forces (without caps attached).

[0113] Fig. 5 is a flowchart of a method for manufacturing a medical bag according to an embodiment.

[0114] Detailed description of the drawings

[0115] Fig. 1 shows an embodiment of a bag 10 filled with a medicinal fluid. The bag 10 is designed here as a three-chamber bag 10. The bag 10 is shown in its unfilled state. Information regarding dimensions and the course of the weld seams refers, by definition, to the unfilled or empty bag 10.

[0116] The bag 10 is formed from two films welded together.

[0117] 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.

[0118] The bag 10 is rectangular in shape. A hanger 13 is located in the upper transverse weld seam 11b for attaching or hanging the bag 10 on a rack or stand. The hanger 13 is designed as an arcuate notch. The upper transverse weld seam 11b widens in the area of ​​the hanger 13.

[0119] The bag 10 is divided into a first chamber 16a, a second chamber 16b and a third chamber 16c via a first peel weld seam 14 and a second peel weld seam 15.

[0120] According to this embodiment, the bag 10 is filled with a total of 220 - 280 ml of a medical liquid.

[0121] The first chamber 10 is preferably filled with a glucose solution and in this embodiment occupies 52 - 58% of the volume, based on the filled liquid.

[0122] The second middle chamber 16b is preferably filled with an amino acid-containing solution and in this embodiment occupies 46 - 50% of the volume.

[0123] The third chamber 16c is preferably filled with a fat emulsion and in this embodiment takes up 0.05 - 0.15 times the volume.

[0124] The first chamber 16a is preferably filled with 110-150 ml. The second chamber 16b is preferably filled with 90-130 ml. The third chamber 16c is preferably filled with 10-30 ml.

[0125] The first chamber 16a has a width of preferably 55-75 mm in its lower section, measured between the right-hand longitudinal weld seam 12a and the lower straight section 14a. The second chamber 16b has a width of preferably 57-77 mm in its lower section, measured between the lower straight sections 14a and 15a. The third chamber 16c has a width of preferably 33-53 mm, measured between the lower straight section 15a and the left-hand longitudinal weld seam 12b.

[0126] The first chamber 16a, here on the right, has a larger width in its upper section than its lower section. The first chamber 16a preferably has a width of 83 - 103 mm in its upper section, measured between the longitudinal weld seam 12a (here on the right) and the straight section 14d.

[0127] The second, central chamber 16b has a larger width in its upper section than its lower section. The second chamber 16b preferably has a width of 75-95 mm in the upper section, measured between the longitudinal weld seam 12b (here on the left) and the straight section 14d.

[0128] Preferably, the upper straight section 14d of the first peel weld seam 14 and the lower straight section 15a of the second peel weld seam 15 are arranged at a distance of 30 to 50 mm from each other.

[0129] Preferably, the lower straight section 14a of the first peel weld 14 has a height or length of 85 to 105 mm, measured between the lower transverse weld 11a and the first bend 14b.

[0130] Preferably, the third chamber 16c has a height of 110-140 mm, particularly measured from the lower transverse weld seam 11a to the transverse section 15c. Three ports 20a-20c are arranged in the lower transverse weld seam 11a.

[0131] The ports 20a - 20c are each closed with an upper part 23, which is placed on a lower part 21.

[0132] There is a seal (not shown) between the lower part 21 and the upper part 23.

[0133] 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.

[0134] 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 10 or to dose it into the bag 10.

[0135] 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.

[0136] 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.

[0137] Port 20a is spaced from port 20b by the distance dl.

[0138] Port 20b is spaced apart from port 20c by a distance d2. In this exemplary embodiment, d2 is greater than dl. dl is 45-55 mm, d2 is 55-65 mm, or 55-60 mm. Preferably, d2 is 5-15 mm greater than dl. This improves the tightness of the welded connection. The ratio of height h to width b of bag 10 in this exemplary embodiment is 1.05-1.25. Bag 10 preferably has a width b of b = 175-205 mm and / or a length or height h of h = 205-235 mm.

[0139] The first peel weld seam 14 is formed from a lower straight section 14a, which merges into an upper straight section 14d via a first curvature 14b and a second curvature 14c.

[0140] The first peel weld seam 14 starts from the lower transverse weld seam 11a between the removal port 20a and the injection port 20b.

[0141] The first straight section 14a and the second straight section 14d run parallel to the longitudinal weld seams 12a, 12b.

[0142] The upper straight section 14d meets approximately centrally the upper transverse weld seam 11b.

[0143] Due to the first curvature 14b and the second curvature 14c, the first peel weld seam 14 undergoes a lateral offset in the direction of the second peel weld seam 15 or the second longitudinal weld seam 12b.

[0144] The first curvature 14b of the first peel weld seam 14 merges directly into the second curvature 14c.

[0145] At the inflection point W, which is formed by the two merging curves 14b and 14c, or, if there is a straight section between the curves 14b and 14c, the first peel weld seam 14 extends at an angle of 30-60° to the longitudinal weld seam 12a. The first and second curves 14b, 14c can, in particular, be formed as eighth-circle segments.

[0146] The second peel weld seam 15 begins at the lower transverse weld seam 11a between the injection port 20b and the blind port 20c. The straight section 15a transitions via a first bend 15b into a transverse section 15c. The transverse section 15c can be partially straight.

[0147] The second peel weld seam 15 extends upwards into the second longitudinal weld seam 12b via a second bend 15d. This reduces stress peaks in this area when the bag is rolled.

[0148] A vertex of the second curvature 15d is located adjacent to the second transverse weld seam 12b. In the transition region, the second curvature 15d runs at an acute angle into the second longitudinal weld seam 12b or runs at an angle of 0° to the second longitudinal weld seam 12b.

[0149] According to the arrangement of the peel weld seams 14, 15, the first right chamber 16a extends partially over the top of the second middle chamber 16b, but not over the third left chamber 16c.

[0150] The second middle chamber 16b extends completely over the third left chamber 16c in the upper area. The third chamber 16c is located in a lower left corner of the bag 10.

[0151] The apex S1 of the first curvature 14b of the first peel weld seam 14 is located, with respect to the height of the bag 10 from the lower transverse weld seam 11a to the upper transverse weld seam 11b, lower than the apex S2 of the first curvature 15b of the second peel weld seam 15.

[0152] When used as intended, the bag 10 is rolled up to open the peel weld seams 14, 15 starting from the top, preferably from the top right, to the bottom, preferably bottom left.

[0153] Due to the selected peel weld seam configuration, the bag 10 is designed such that the first peel weld seam 14 begins to open in an area between the lower transverse weld seam 11a and the first bend 14b of the first peel weld seam 14. The first peel weld seam 14 then tears open all the way down.

[0154] When used as intended, however, the second peel weld seam 15 only begins to open when the first peel weld seam 14 has already torn open sufficiently.

[0155] The component present in the third chamber 16c can thus be used optionally.

[0156] If the third chamber 16c is to be opened, the bag is rolled further and the second peel weld seam 15 tears open in an area between the lower transverse weld seam 11a and the first bend 15b of the second peel weld seam 15. The second peel weld seam 15 tears open upwards in the direction of the second bend 15b and also opens downwards to the lower transverse weld seam 11a.

[0157] Fig. 1a is a detailed view of the second peel weld 15 in the area of ​​the transition to the longitudinal weld 12b. The second bend 15d merges into the outer edge of the longitudinal weld 12b (dashed line). On the inside, the second bend 15d merges into the inner edge of the longitudinal weld.

[0158] In particular, the second curvature 15d is formed as a ring segment, wherein an outer tangent of the ring segment is approximately aligned with the outer edge of the longitudinal weld seam 12b and an inner tangent of the ring segment is approximately aligned with the inner edge of the longitudinal weld seam.

[0159] As shown with reference to Fig. 2, the bag 10 is packaged in a secondary packaging 30. The secondary packaging 30 is designed as a tear-open bag made of two films welded together.

[0160] 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.

[0161] Fig. 3 shows an alternative embodiment of a bag 10 filled with a medical liquid.

[0162] In contrast to the embodiment shown in Fig. 1, the bag is designed to be higher, ie the distances between the ports 20a - 20c and the peel weld seams 14, 15 correspond or substantially correspond to the embodiment according to Fig. 1.

[0163] The ratio of height h to width b in this embodiment is 1.4-1.7. Preferably, the bag 10 has a width b of b = 175-205 mm and / or a length or height h of h = 275-305 mm. Preferably, the lower rectilinear section 14a of the first peel weld seam 14 has a height or length of 135 to 155 mm, measured between the lower transverse weld seam 11a and the first bend 14b.

[0164] Preferably, the third chamber 16c has a height of 175 - 205 mm, in particular measured from the lower transverse weld seam 11a to the transverse section 15c.

[0165] In this embodiment, the first chamber 16a occupies 50-60% of the volume of the medicinal fluid. The second, middle chamber 16b occupies 0.35-0.45% of the volume. The third chamber 16c occupies 0.08-0.15% of the volume of the medicinal fluid.

[0166] The bag shown in Fig. 3 is filled with a total of 400-600 ml, preferably 450-550 ml, of liquid. The first chamber 16a is preferably filled with 240-285 ml. The second chamber 16b is preferably filled with 175-220 ml. The third chamber 16c is preferably filled with 40-75 ml.

[0167] With reference to Fig. 4, the determination of the tear force of the peel weld seams 14, 15 will be further explained.

[0168] First, using the peel weld seam 14 as an example, a 30 mm wide section 17 of the two films is cut out along a straight section of the peel weld seam 14.

[0169] On one side of the strip-shaped cutout 17, 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 tear force. Fig. 5 is a flowchart of an embodiment of the method 100 according to the invention for producing a medical bag 10.

[0170] A first and a second film are provided 101. The films are preferably formed as multilayer polyolefin films.

[0171] The films are then welded to form the bag 10 by means of a contact welding process, wherein at least one removal port 20a is welded 102 into a lower transverse weld seam 11a.

[0172] The bag is then welded 103 into the three chambers 16a - 16c by welding a first peel weld seam 14 and a second peel weld seam 15. The peel weld seams 14, 15 are thus carried out after the welding of the longitudinal and transverse weld seams 11a, 11b, 12a, 12b.

[0173] The course of the peel weld seams 14, 15 corresponds to the representation according to Fig. 1 or Fig. 4.

[0174] The bag is then packed in a tear-open bag 30, preferably shrink-wrapped, 104 and autoclaved 105 together with the tear-open bag 30.

[0175] The invention makes it possible to provide a medical bag 10 which is particularly suitable for relatively small volumes in pediatric applications.

[0176] List of reference symbols

[0177] 10 bags

[0178] 11a lower transverse weld 11b upper transverse weld

[0179] 12a first longitudinal weld

[0180] 12b second longitudinal weld

[0181] 13 trailers

[0182] 14 first peel weld

[0183] 14a lower straight area or section

[0184] 14b first bend

[0185] 14c second bend

[0186] 14d upper straight area or section

[0187] 15 second peel weld

[0188] 15a lower straight area or section

[0189] 15b first bend

[0190] 15c transverse area or section

[0191] 15d second curvature

[0192] 16a first chamber

[0193] 16b second chamber

[0194] 16c third chamber

[0195] 17 Excerpt

[0196] 20a Port / withdrawal port

[0197] 20b Port / Injection port

[0198] 20c port / blind port

[0199] 21 Lower part

[0200] 22 Weld-in section

[0201] 23 Top

[0202] 24 Break-off cap

[0203] 30 On ziplock bags

[0204] 31 notch

[0205] 100 Methods for manufacturing a medical bag

[0206] 101 Providing a first and a second slide

[0207] 102 Welding the first and second foil to the

[0208] Bag (10), wherein at least one removal port (20a) is welded into a lower transverse weld seam (11a). Dividing the bag (10) into three chambers (16a-16c) by welding a first peel weld seam (14) and a second peel weld seam (15). Welding the bag (10) in a tear-open bag (30). 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 first peel weld seam (14) extends from the lower transverse weld seam (11a) to the upper transverse weld seam (11b), wherein the second peel weld seam (15) extends from the lower transverse weld seam (11a) to the second longitudinal weld seam (12b), and wherein the bag (10) is welded by a first peel weld seam (14) and a second peel weld seam (15) is divided into three chambers (16a-16c), and wherein in the lower transverse weld seam (11a) at least three ports (20a-20c) are arranged, each of which is connected to one of the three chambers (16a-16c).

2. Bag (10) filled with a medicinal liquid according to the preceding claim, characterized in that the second peel weld seam (15) runs over a first curvature (15b) in the direction of the second longitudinal weld seam (12b) and / or that the second peel weld seam (15) merges into the second longitudinal weld seam (12b) over a second curvature (15d).

3. Bag (10) filled with a medicinal liquid according to one of the preceding claims, characterized in that the first peel weld seam (14) is a first, lower curve (14b) runs in the direction of the second peel weld seam (15) and is returned via a second, upper curve (14c) in the direction of the upper transverse weld seam (11b).

4. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that an apex of the first curvature (14b) of the first peel weld seam (14) is arranged lower than an apex of the first curvature (15b) of the second peel weld seam (15).

5. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that an outer first chamber (16a) and / or a middle second chamber (16b) extends from the lower transverse weld seam (11a) to the upper transverse weld seam (11b) and / or that an outer third chamber (16c) is delimited by the second peel weld seam (15), the lower transverse weld seam (lla) and the second longitudinal weld seam (12b) .

6. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the first peel weld seam (14) below the first curvature (14b) comprises a lower rectilinear section (14a), which in particular merges into the first curvature (14b) and / or that the first peel weld seam (14) above the second curvature (14c) comprises an upper rectilinear section (14d), in particular wherein the second curvature (14c) in the direction of the upper transverse weld seam (llb) merges into the upper straight section (14d).

7. Bag (10) filled with a medicinal liquid according to the preceding claim, characterized in that the lower rectilinear section (14a) of the first peel weld seam (14) and / or the upper rectilinear section (14d) of the first peel weld seam (14) runs or run substantially parallel to the longitudinal weld seams (12a, 12b).

8. Bag (10) filled with a medicinal liquid according to one of the preceding claims, characterized in that the second peel weld seam (15) comprises a lower rectilinear section (15a) which extends over the first curvature (15b) of the first peel weld seam (15) into a section extending transversely in the direction of the second The area (15c) running along the longitudinal weld seam (12b) passes over.

9. Bag (10) filled with a medical liquid according to the preceding claim, characterized in that the first rectilinear region (15a) of the second peel weld seam (15) runs substantially parallel to the longitudinal weld seams (12a, 12b) and / or that the region (15c) of the second peel weld seam (15) running transversely in the direction of the second longitudinal weld seam (12b) runs at least in sections substantially parallel to the transverse weld seams (11a, 11b).

10. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the bag (10) is divided into a right first chamber (16a), a middle second chamber (16b) and a left third chamber (16c) by the first peel weld seam (14) and the second peel weld seam (15).

11. Bag (10) filled with a medicinal liquid according to the preceding claim, characterized in that the right first chamber (16a) extends in the upper region only over the middle second chamber (16b) but not over the left third chamber (16c), and / or that the second middle chamber (16b) extends in the upper region over the third left chamber (16c).

12. 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).

13. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized in that the bag (10) is filled with 200 to 600 ml of medical liquid, in particular with 200 to 300 ml or with 400 to 600 ml of medical liquid.

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, the first peel weld seam (14) can initially be torn open in a region between the first curvature (14b) and the lower transverse weld seam (11a) and / or that when the bag (10) is rolled up from top to bottom, the second peel weld seam (15) can initially be torn open in a region between the first curvature (15b) and the lower transverse weld seam (11a).

15. Bag (10) filled with a medical liquid according to one of the preceding claims, characterized characterized in that the first chamber (16a), in particular the chamber filled with a glucose component, contains 0.4 to 0.7 times, in particular 0.5 to 0.6 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 0.3 to 0.6 times, in particular 0.35 to 0.5 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 medical liquid according to one of the preceding claims, characterized in that the first peel weld seam (14) and / or the second peel weld seam (15) is / are designed such that the films of a 30 mm long rectilinear strip can be separated from one another at a force between 10 and 30 N, preferably between 15 and 25 N, particularly preferably between 17.5 and 22.5 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 in a lower transverse weld seam (11a) at least one removal port (20a) is welded in, - dividing the bag (10) into three chambers (16a-16c) by welding a first peel weld seam (14) and a second peel weld seam (15), and wherein the first peel weld seam (14) is welded in such a way that it runs from the lower transverse weld seam (11a) to an opposite side of the bag (10), wherein the second peel weld seam (15) is welded in such a way that it initially runs upwards from the lower transverse weld seam (11a) and then changes direction via a bend (15b) and ends on a longitudinal side of the bag (10), wherein at least 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), and wherein the three chambers (16a-16c) of the bag (10) are filled with a medical liquid via a port (20a-20c) each.

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