Bag which is filled with a medical fluid and has curved tear zones, and method for producing same
Patent Information
- Application Number
- AU2025247415
- Authority / Receiving Office
- AU · AU
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-03-25
- Filing Date
- 2025-03-25
- Publication Date
- 2026-09-17
Smart Images
Figure 00000000_0000_ABST
Abstract
Description
Field of the invention The invention relates to a bag filled with a medical fluid. In particular, the invention relates to a three-chamber bag with an enteral or parenteral nutritional composition. The invention further relates to a method for producing a medical bag. Background of the invention Film bags are often used for enteral or parenteral nutritional compositions. A film bag of this kind is provided with at least one withdrawal port. It can be pierced with a spike or a needle such that the nutritional composition can be transferred to the patient by means of a transfer set. Parenteral nutritional compositions of this kind generally comprise a glucose-containing solution, an amino acid-containing solution and a fat emulsion. However, these components can only be stored separately from one another for a longer period of time. The published patent application WO 2006 / 010410 A1 (Applicant: Fresenius Kabi Deutschland GmbH) shows a three-chamber bag made of films welded to one another. The bag is divided into three chambers via peel weld seams. The largest chamber, which is usually filled with the glucose-containing solution, extends via the other two chambers in the upper region of the bag. The peel weld seams are weld seams which, when pressure is applied to the bag, in particular by rolling up the bag, preferably laterally, from top to bottom, tear open such that the contents of the three chambers can mix. The medical bag described in the above document comprises peel seams with an S-shaped zone, which is referred to there as what is known as a tearopen zone and which assists in tearing open the peel weld seams. Peel weld seams differ from other or permanent weld seams in that the material is less strongly liquefied during welding, for example due to a lower welding temperature and / or a shorter contact time. On the one hand, the peel weld seams must be sufficiently stable such that the peel weld seams are not unintentionally torn open during transport of the bag, thereby opening the chambers. On the other hand, however, the peel weld seams should also be designed in such manner that the user does not have to exert excessive force, when rolling the bag, to exert sufficient pressure to open the peel weld seams. It has been shown that it is more difficult, in particular in the case of relatively small medical bags, to provide peel weld seams with good tear-open properties. In particular, for paediatric applications, the volume of medical fluid in the bag is generally lower, usually below 1000 ml. The peel weld seams should open when the bag is rolled up downwards, i.e. up to the lower transverse weld seam in which the withdrawal port is located. This is the only way to ensure that the various components of the nutritional composition are sufficiently well mixed. This is particularly important for paediatric applications, as the contents of the bag may also only be partially used. Object of the invention The object underlying the invention is to provide a multi-chamber bag, in particular a three-chamber bag, which has an improved tear-open behaviour of the peel weld seams, in particular for smaller volumes, for example for paediatric applications, of less than 1000 ml or less than 750 ml. Summary of the invention The object of the invention is already achieved by a bag filled with a medical fluid and by a method for producing a bag filled with a medical fluid according to one of the independent claims. Preferred exemplary embodiments and further developments of the invention can be found in the subject matter of the dependent claims, the description and the drawings. The invention relates to a bag which is filled with a medical fluid and which 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 withdrawal 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 up to the upper transverse weld seam, and wherein the second peel weld seam 3 extends from the lower transverse weld seam up 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 here in the form of a bag with exactly three or at least three chambers. According to independent claim 1, the invention is described by way of a bag which is filled with a medical fluid and which 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 withdrawal port is arranged in the lower transverse weld seam, wherein the first peel weld seam extends from the lower transverse weld seam up to the upper transverse weld seam, wherein the second peel weld seam extends from the lower transverse weld seam up 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 in the lower transverse weld seam are arranged at least three ports, each of which is connected to one of the three chambers A first outer chamber, in particular arranged here on the right, extends from the lower transverse weld seam to the upper transverse weld seam. In particular, in contrast to the aforementioned prior art for three-chamber bags, the first chamber, in particular arranged here on the right, therefore does not extend over the entire width of the medical bag. The second, here the middle, chamber extends from the lower transverse weld seam up to the upper transverse weld seam. The third chamber, in particular a chamber arranged here on the left and filled with a fat emulsion, on the other hand, only adjoins an outer edge of the bag on two sides and is thus arranged in a corner region within a middle chamber. The third chamber is delimited by the second peel weld seam, the lower transverse weld seam and the longitudinal weld seam arranged here on the left. It has been shown that a configuration of this kind of the peel weld seams ensures a significantly improved tear-open behaviour, in particular with smaller bags. The right and left sides of the bag are defined in particular by the bag being placed with its rear side on a table. The peel seams of the bag are preferably opened by rolling up the bag from top right to bottom left. Here, in particular, the upper side of the bag is also defined by the position of the hanger and the hanging of the bag on a stand via its hanger. In particular, when the bag is rolled, the first peel weld seam opens first, which runs from the lower transverse weld seam to the upper transverse weld seam or which runs between the lower transverse weld seam and the upper transverse weld seam. When the bag is rolled up further, the second peel weld seam opens, thereby opening the chamber, which is preferably filled with a fat emulsion. This tear-open behaviour allows the user to use the third chamber of the bag only optionally. In particular, in paediatric applications, the addition of a fat component is sometimes dispensed with. The terms "longitudinal weld seam" and "transverse weld seam" are used for the purposes of distinction within the meaning of the invention. By definition, the lower transverse weld seam forms the lower edge or - lower side of the bag during intended use, i.e. when the bag is used with a downward-facing port 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 w. In a preferred embodiment of the invention, the second peel weld seam runs via a first curve in the direction of the second longitudinal weld seam. The second peel weld seam therefore changes the direction via the curve and ends at the second longitudinal weld seam or merges into it. The first curve of the second peel weld seam provides a left curve. The first curve of the second peel weld preferably runs at approximately 90° and can, for example, be in the form of a quarter circle. According to a further development of the invention, the second peel weld seam merges into the second longitudinal weld seam via a second curve, running in particular in the direction of the upper transverse weld seam. In this configuration, the second peel weld seam therefore does not end at a right angle in the second longitudinal weld seam, but instead makes a curve, preferably a curve upwards, and then ends in the second longitudinal weld seam. This second curve can, for example, be in the form of a circle segment. In particular, it is provided that the second curve of the second peel weld seam has an apex which, with respect to the width of the bag, is arranged between the second longitudinal weld seam and the first curve of the second peel weld seam. In the overlap region of the second longitudinal weld seam and the second peel weld seam, these weld seams run, with respect to their centre, preferably at an acute angle, preferably at an angle of less than 70°, in particular at an angle of 0° - 50°. There is therefore a tangent following the course of the second peel weld seam centrally in the overlap region at an angle of less than 70°. Pressure peaks in this region are avoided by the second peel weld seam ending in a curve. This ensures, in particular, that the second peel weld seam initially tears open below the first curve during intended use and then opens up to the lower transverse weld seam. In a preferred embodiment of the invention, the first peel weld seam runs via a first, lower curve initially in the direction of the second peel weld seam and is then led back via a second, upper curve in the direction of the upper transverse weld seam. The first peel weld seam therefore has a lateral offset. In particular, the first peel weld seam has an S-shaped region which is formed by the two curves. This allows, on the one hand, the volume of the first chamber, which is filled in particular with a glucose-containing solution, to be increased in relation to the other chambers. Furthermore, this configuration ensures that when the bag is rolled up from the top, in particular from top right, to the bottom, in particular to bottom left, the first peel weld seam opens in a region between the first curve and the lower transverse weld seam and then tears open downwards up to the lower transverse weld seam. In contrast to the prior art mentioned at the outset, the S-shaped course formed by the two curves is preferably not used as the initial tear-open zone. The initial tear-open zone, where the tearing starts, is rather located therebelow. In particular, the initial tear-open zone is located substantially centrally in the lower straight section. In a further development of the invention, the apex of the first curve of the first peel weld seam, starting from the upper transverse weld seam, is arranged lower than the apex of the first curve of the second peel weld seam. The first curves of the two peel weld seams therefore lie offset in height with respect to the longitudinal weld seams. This arrangement also improves the tear-open behaviour such that the first peel weld seam begins to tear open below the first curve and then tears open up the lower transverse weld seam. In a preferred embodiment of the invention, in the first transverse weld seam are arranged at least two, preferably three, ports, each of which is connected to one of the three chambers. The ports can be used to fill the chambers of the medical bag. At least one first port is provided, which is in the form of a withdrawal port. It can comprise a sealing element which can be pierced by means of a needle or a spike, in particular what is known as a stopper, in order to be able to withdraw the medical fluid and transfer it to the patient, for example via a delivery system. A second port can be in the form of an injection port. It also comprises a pierceable sealing element, in particular what is known as a septum, through which, for example, medicines and / or additives can be transferred into the bag by means of a syringe. Lastly, there may also be a third port, which is preferably in the form of a blind port. It is used only for filling a chamber of the bag and is closed with a stopper and a cap. The withdrawal port and / or the injection port are preferably in the form of connectors. The connector on the withdrawal port is used to connect a transfer set, for example by opening or piercing the withdrawal port by means of a spike of 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 in the form of a threadless Luer connection or a Luer lock connection with a thread, and can 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 curve in the direction of the second peel weld seam, a second curve in the direction of the upper transverse weld seam, and an adjoining upper straight section. In one embodiment, the lower straight section and / or the upper straight section run(s) substantially parallel, preferably parallel, to the longitudinal weld seams. The first peel weld seam thus runs from bottom to top, wherein it has a lateral offset via an S-shaped curve. The lateral offset runs, viewed from below, in the direction of the second peel weld seam or the second longitudinal weld seam. According to one embodiment, the second peel weld seam comprises a lower straight section which, via the first curve of the first peel weld seam, merges into a region running transversely in the direction of the second longitudinal weld seam. In one configuration, the first straight region runs substantially parallel, preferably parallel, to the longitudinal weld seams. The first curve of the second peel weld seam is preferably substantially in the form of a 90° curve. The region running transversely in the direction of the second longitudinal weld seam can therefore run, at least in sections, substantially parallel, preferably parallel, to the transverse weld seams. According to another embodiment, it is provided that there is no straight region present between the first curve and the second curve, in particular that the first curve merges directly into the second curve of the second peel weld seam. The first peel weld seam and the second peel weld seam divide the bag into a right first chamber, a middle second chamber and a left third chamber. The first chamber is in particular the outer right chamber. The third chamber is in particular the outer left chamber. The second chamber lies 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. The right first chamber extends in the upper region only via the middle second chamber, but not via the third left chamber. The second chamber extends via the third left chamber in the upper region. The bag is preferably arranged sterile in a secondary package. In particular, the bag is arranged in a tear-open bag. According to a preferred embodiment of the invention, the bag is filled with 200 - 600 ml of medical fluid, in particular with 200 - 300 ml or with 400 - 600 ml of medical fluid. Within the meaning of the invention, this is understood to mean the total amount of medical fluid in the three chambers. Preferably, in addition to the medical fluid, there is a gas volume located in the chambers, in particular an inert gas, such as nitrogen. Since the gas volume is compressible, impacts are better absorbed and the likelihood of the bag bursting, for example if it falls, is minimised. 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. The bag is preferably designed in such manner that when the bag is rolled up, in particular laterally, from top to bottom, the first peel weld seam initially begins to tear open in a region between the first curve and the lower transverse weld seam. The tearing-open then preferably proceeds upwards and downwards. In particular, during intended use, the first peel weld seam opens up to the lower transverse weld seam. An upper region, adjoining the upper transverse weld seam, may open, but does not have to. The chambers are then connected to one another at least in their lower region such that the components of the first chamber and the second chamber can mix well. The second peel weld seam also begins to tear open when the bag is rolled up in a region between the first curve and the lower transverse weld seam. Here, the tearing-open takes place in particular downwards and upwards, preferably until the second peel weld seam is torn open up to the lower transverse weld seam during intended use. The second peel weld seam does not have to open all the way upwards to the upper transverse weld seam either. This tear-open behaviour in particular allows the third chamber to be used only optionally. The bag preferably has a height to width ratio, h to w, of 1.05 - 1.8, particularly preferably of 1.1 - 1.6. This ratio is particularly suitable for small volumes. According to one embodiment, the apices of the first curve of the first peel weld seam and the first curve of the second peel weld seam are spaced at least 3 mm, preferably 3 - 50 mm, in particular 5 - 30 mm, in height (along the longitudinal weld seam). In one embodiment of the invention, the second curve of the second peel weld seam has a radius of 10 - 20 mm. The first and / or second curve of the first peel weld seam can have a radius of 20 - 40 mm. By definition, the radius is in each case the outer radius of the curve. The first chamber preferably has the largest volume of fluid. 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 medical fluid. The second chamber, in particular the middle chamber, is preferably filled with an amino acid component and has 0.3 to 0.6 times, in particular 0.35 to 0.5 times, the volume of the medical fluid. 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 medical fluid. The peel weld seams preferably have a width of 2 - 4 mm, particularly preferably of 2.5 to 3.5 mm. The apices of the first curve of the first peel weld seam and / or the first curve of the second peel weld seam are preferably arranged in a range 1 / 3 - 2 / 3 of the height of the bag. According to one embodiment, the first peel weld seam ends approximately centrally in the upper transverse weld seam. The first peel weld seam can in particular end in a region of the second transverse weld seam in which a hanger for hanging the bag is located. This can in particular be a cut or a through-hole. The first curve and / or the second curve of the first peel weld seam can each be in the form of one-eighth of a circle. The first curve of the second peel weld seam is preferably in the form of a quarter circle. The first curve and / or the second curve of the first peel weld seam run in a transition region, in particular at a turning point, preferably obliquely, but not perpendicularly to the longitudinal weld seams, in particular at an angle of 30 -60°. The films are preferably in the form of multi-layer polyolefin films. The films are in particular in the form of multi-layer polypropylene films. At least one layer of the film, in particular all layers of the film, can be in the form of a matrix-phase polymer system. In a matrix-phase polymer system, there are at least two different polymers present, wherein one polymer is present in the matrix of the other polymer in a demixed state, in particular as dispersed, solidified droplets. 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. SEBS is a block polymer which is composed of styrene, butylene and ethylene segments and which comprises a hydrogenated butadiene segment followed by styrene groups. This is produced in particular by polymerising a styrene and butadiene monomer and then hydrogenating the previously polymerised SBS. The hydrogenated butadiene forms a soft middle block between styrene blocks. The SEBS forms a bond with the PP matrix polymer. By way of a multi-layer system of this kind, by using other components and / or compositions in the respective layers, highly transparent and at the same time very tear-resistant films can be provided, which can be easily welded to form a bag. According to one embodiment, the first and second peel weld seams are designed in such manner that the films of a 30 mm long straight strip separate from one another with a force of between 10 and 30 N, preferably between 15 and 25 N, and particularly preferably between 17.2 and 22 N. A 30 mm wide cutout is cut out along a straight section of the peel weld seam. The films are pulled apart on one side of the strip and the maximum force required to separate the strips is measured by means of a force measuring device. According to one embodiment, the bag does not comprise an inner bag. No further bags, for example small, bags are arranged or introduced in the chambers of the bag. They are each free of an inner bag. In particular, the bag comprises exactly three chambers, which are formed from exactly two films welded to one another. The bag is designed in particular for paediatric applications. The invention further relates to a method for producing a bag filled with a medical fluid, comprising the steps: - Providing a first and a second film; - Welding the first and second films to form the bag, wherein at least one withdrawal port is welded in a lower transverse weld seam, - Dividing the bag into three chambers by welding a first peel weld seam and a second peel weld seam, and wherein the first peel weld seam is welded in such manner that it runs starting from the lower transverse weld seam to an opposite side of the bag, wherein the second peel weld seam is welded in such manner that it first runs upwards from the lower transverse weld seam and then changes the direction via a curve and ends at a long side of the bag. According to independent claim 18, the invention will be described by a method for producing a bag filled with a medical fluid, comprising the steps: - Providing a first and a second film; - Welding the first and second films to form the bag, wherein at least one withdrawal port is welded in a lower transverse weld seam, - Dividing the bag into three chambers by welding a first peel weld seam and a second peel weld seam, and wherein the first peel weld seam is welded in such manner that it runs starting from the lower transverse weld seam to an opposite side of the bag, wherein the second peel weld seam is welded in such manner that it first runs upwards from the lower transverse weld seam and then changes the direction via a curve and ends at a long side of the bag, wherein in the lower transverse weld seam are arranged at least three ports, each of which is connected to one of the three chambers, and wherein the three chambers of the bag are filled with a medical fluid via respectively one 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 welding the lower transverse weld seam and / or after welding at least the second longitudinal weld seam. In particular, it is provided that the peel weld seams are welded after welding the longitudinal and transverse weld seams. The peel weld seams therefore overlap with the respective longitudinal and transverse weld seam, at which the respective peel weld seam ends. This ensures that there is no weakened zone of the respective transverse or longitudinal weld seam in the region of the overlap. In the overlap region, only an imprint of the overlapping peel weld seam is present on the transverse or longitudinal weld seam. After welding the transverse weld seam and the peel weld seams, in particular after welding all weld seams, the chambers of the bag are filled with medical fluid via respectively one port. At least the lower transverse weld seam and the peel weld seams are preferably welded by means of a contact welding method. In a contact welding method of this kind, a welding tool is pressed against the film layers, the welding tool having a heatable sealing bar that corresponds to the contour of the respective weld seam. The contact time and the 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 longitudinal or transverse weld seam. In the case of the peel weld seams, the material is in particular less liquefied such that they are designed in such manner that they can tear open when targeted 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. After filling and closing the ports, the bag is preferably packaged in a secondary package and sterilised in the secondary package. The secondary package can in particular be in the form of a tear-open bag, i.e. a bag with films welded to one another. The films of the tear-open bag preferably comprise an oxygen barrier layer, in particular a metal or metal oxide layer. The bag packaged in the secondary package is preferably sterilised by autoclaving. Brief description of the drawings The subject matter of the invention will be explained in more detail below with reference to the drawings Fig. 1 to Fig. 5. Fig. 1 shows an exemplary embodiment of a bag filled with a medical fluid. Fig. 1a is a detailed view of the second peel weld seam in the region of the transition to the longitudinal weld seam. Fig. 2 shows the bag from Fig. 1 arranged in a secondary package (with caps attached). Fig. 3 shows a further exemplary embodiment of a bag filled with a medical fluid. Fig. 4 shows the bag from Fig. 3 to illustrate the measurement of the tearopen forces (without caps attached). Fig. 5 is a flow diagram of a method for producing a medical bag according to an exemplary embodiment. Detailed description of the drawings Fig. 1 shows an exemplary embodiment of a bag 10 filled with a medical fluid. The bag 10 is here in the form of a three-chamber bag 10. The bag 10 is represented in its unfilled state. Information on size ratios and the course of the weld seams refers by definition to the unfilled or empty bag 10. The bag 10 is formed from two films welded to one another. The films are welded to one another via a lower transverse weld seam 11a, an upper transverse weld seam 11b, a first longitudinal weld seam 12a represented here on the right, and a second longitudinal weld seam 12b represented here on the left. The bag 10 is rectangular in shape. In the upper transverse weld seam 11b there is located a hanger 13 for attaching or hanging the bag 10 on a rack or stand. The hanger 13 is here in the form of an arcuate cut. The upper transverse weld seam 11b widens in the region of the hanger 13. 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. According to this exemplary embodiment, the bag 10 is filled with a total of 220 - 280 ml, of a medical fluid. The first chamber 10 is preferably filled with a glucose solution and, in this exemplary embodiment, takes up 52 - 58% of the volume, with respect to the fluid filled in. The second middle chamber 16b is preferably filled with an amino acidcontaining solution and, in this exemplary embodiment, takes up 46 - 50% of the volume. The third chamber 16c is preferably filled with a fat emulsion and, in this exemplary embodiment, takes up 0.05 - 0.15 times the volume. 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. The first chamber 16a has a width of preferably 55 - 75 mm in its lower section, measured between the longitudinal weld seam 12a, here on the right, 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 longitudinal weld seam 12b, here on the left. The first chamber 16a, here on the right, has a greater width in its upper section than in 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. The second chamber 16b, here in the middle, has a greater width in its upper section than in its lower section. The second chamber 16b preferably has a width of 75 - 95 mm in its upper section, measured between the longitudinal weld seam 12b, here on the left, and the straight section 14d. 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 one another. Preferably, the lower straight section 14a of the first peel weld seam 14 has a height or length of 85 to 105 mm, measured between the lower transverse weld seam 11a and the first curve 14b. The third chamber 16c preferably has a height of 110 - 140 mm, in particular measured from the lower transverse weld seam 11a up to the transversely running section 15c. Three ports 20a - 20c are arranged in the lower transverse weld seam 11a. The ports 20a - 20c are each closed with an upper part 23, which is placed on a lower part 21. There is located a seal (not represented) between the lower part 21 and the upper part 23 in each case. The port 20a is connected to the first chamber 16a and is in the form of a withdrawal port 20a. The port 20b is in the form of an injection port 20b. The withdrawal port 20a and the injection port 20b each comprise an upper part 23, which is provided with a break-off cap 24. After breaking off the break-off cap 24, the seal can be pierced with a spike or a needle in order to withdraw fluid from the bag 10 or to dose it into the bag 10. The port 20c is in the form of a blind port and is only used to fill the third chamber 16c. Accordingly, it is only closed with an upper part 23 in the form of a cap, wherein a seal is also arranged between the cap and the lower part 21 of the port 20c. The lower part 21 each comprises a weld-in section 22, with which the respective port 20a to 20c is welded in the lower transverse weld seam 11a. The port 20a is spaced from the port 20b by the distance d1. The port 20b is spaced from the port 20c by a distance d2. In this exemplary embodiment, d2 is greater than d1. d1 is 45 - 55 mm, d2 is 55 - 65 or 55 - 60 mm. Preferably, d2 is 5 - 15 mm greater than d1. This improves the tightness of the welded connection. The ratio of height h to width w of the bag 10 is 1.05 - 1.25 in this exemplary embodiment. Preferably, the bag 10 has a width w of w = 175 - 205 mm and / or a length or height h of h = 205 - 235 mm. The first peel weld seam 14 is formed from a lower straight section 14a, which merges via a first curve 14b and a second curve 14c into an upper straight section 14d. The first peel weld seam 14 starts from the lower transverse weld seam 11a between the withdrawal port 20a and the injection port 20b. The first straight section 14a and the second straight section 14d run parallel to the longitudinal weld seams 12a, 12b. The upper straight section 14d meets the upper transverse weld seam 11b approximately centrally. Due to the first curve 14b and the second curve 14c, the first peel weld seam 14 makes a lateral offset in the direction of the second peel weld seam 15 or the second longitudinal weld seam 12b. The first curve 14b of the first peel weld seam 14 merges here directly into the second curve 14c. At the turning point W, which is formed by the two merging curves 14b and 14c, or, if there is a straight section located between the curves 14b and 14c, the first peel weld seam 14 runs there at an angle of 30 - 60° to the longitudinal weld seam 12a. The first and second curves 14b, 14c can in particular be in the form of one-eighth-circle segments. 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 merges via a first curve 15b into a transversely running section 15c. The transversely running section 15c may be partially straight. The second peel weld seam 15 runs upwards via a second curve 15d into the second longitudinal weld seam 12b. This reduces stress peaks when the bag is rolled in this region. An apex of the second curve 15d is arranged next to the second transverse weld seam 12b. In the transition region, the second curve 15d runs into the second longitudinal weld seam 12b at an acute angle or runs at an angle of 0° to the second longitudinal weld seam 12b. In accordance with the arrangement of the peel weld seams 14, 15, the first right chamber 16a extends at the top in regions via the second middle chamber 16b, but not via the third left chamber 16c. The second middle chamber 16b extends completely via the third left chamber 16c in the upper region. The third chamber 16c is arranged in a left lower corner of the bag 10. The apex S1 of the first curve 14b of the first peel weld seam 14 lies, 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 curve 15b of the second peel weld seam 15. During intended use, 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 to the bottom left. Due to the chosen peel weld seam configuration, the bag 10 is designed in such manner that the first peel weld seam 14 begins to open in a region between the lower transverse weld seam 11a and the first curve 14b of the first peel weld seam 14. The first peel weld seam 14 then tears open downwards. In contrast, during intended use, the second peel weld seam 15 begins to open in particular only when the first peel weld seam 14 has already been torn open sufficiently. The component present in the third chamber 16c can thus be used optionally. If the third chamber 16c is to be opened, the bag is rolled further and the second peel weld seam 15 tears open in a region between the lower transverse weld seam 11a and the first curve 15b of the second peel weld seam 15. The second peel weld seam 15 thereby tears open upwards in the direction of the second curve 15b and also opens downwards up to the lower transverse weld seam 11a. Fig. 1a is a detailed view of the second peel weld seam 15 in the region of the transition to the longitudinal weld seam 12b. The second curve 15d merges externally into the outer edge of the longitudinal weld seam 12b (dashed line). On the inside, the second curve 15d merges into the inner edge of the longitudinal weld seam. In particular, the second curve 15d is designed 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 aligned with the inner edge of the longitudinal weld seam. As represented with reference to Fig. 2, the bag 10 is packaged in a secondary package 30. The secondary package 30 is in the form of a tear-open bag formed from two films welded to one another. A longitudinal weld seam of the tear-open bag 30 has a notch 31 on the edge to make it easier to tear open the tear-open bag 30. Fig. 3 shows an alternative exemplary embodiment of a bag 10 filled with a medical fluid. In contrast to the exemplary embodiment represented in Fig. 1, the bag is higher, i.e. the distances between the ports 20a - 20c and the peel weld seams 14, 15 correspond or substantially correspond to the exemplary embodiment according to Fig. 1. The ratio of height h to width w in this exemplary embodiment is 1.4 - 1.7. Preferably, the bag 10 has a width w of w = 175 - 205 mm and / or a length or height h of h = 275 - 305 mm. Preferably, the lower straight 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 curve 14b. The third chamber 16c preferably has a height of 175 - 205 mm, in particular measured from the lower transverse weld seam 11a up to the transversely running section 15c. In this exemplary embodiment, the first chamber 16a takes up 50 - 60% of the volume of the medical fluid. The second middle chamber 16b takes up 0.35 -0.45% of the volume. The third chamber 16c takes up 0.08 - 0.15% of the volume of the medical fluid. The bag represented in Fig. 3 is filled with a total of 400 - 600 ml, preferably 450 - 550 ml, of fluid in total. 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. With reference to Fig. 4, the determination of the tear-open force of the peel weld seams 14, 15 will also be explained. First, using the peel weld seam 14 as an example, a 30 mm wide cutout 17 of the two films is cut out along a straight section of the peel weld seam 14. 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 for separating the film strips is measured by means of a force measuring device. This maximum force corresponds to the tear-open force. Fig. 5 is a flow diagram of an exemplary embodiment of the method 100 according to the invention for producing a medical bag 10. A first and a second film are provided 101. The films are preferably in the form of multi-layer polyolefin films. The films are then welded to form the bag 10 by means of a contact welding method, wherein at least one withdrawal port 20a is welded 102 in a lower transverse weld seam 11a. The bag is then divided 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 therefore made after welding the longitudinal and transverse weld seams 11a, 11b, 12a, 12b. The course of the peel weld seams 14, 15 corresponds to the representation in Fig. 1 or Fig. 4. The bag is then packaged in a tear-open bag 30, preferably welded in 104, and autoclaved 105 together with the tear-open bag 30. The invention makes it possible to provide a medical bag 10 which is in particular suitable for relatively small volumes in paediatric applications. List of reference numbers 10 Bag 11a Lower transverse weld seam 11b Upper transverse weld seam 12a First longitudinal weld seam 12b Second longitudinal weld seam 13 Hanger 14 First peel weld seam 14a Lower straight region or section 14b First curve 14c Second curve 14d Upper straight region or section 15 Second peel weld seam 15a Lower straight region or section 15b First curve 15c Transversely running region or section 15d Second curve 16a First chamber 16b Second chamber 16c Third chamber 17 Cutout 20a Port / withdrawal port 20b Port / injection port 20c Port / blind port 21 Lower part 22 Weld-in section 23 Upper part 24 Break-off cap 30 Tear-open bag 31 Notch 100 Method for producing a medical bag 101 Providing a first and a second film 102 Welding the first and second films to form the bag (10), wherein at least one withdrawal port (20a) is welded in a lower transverse weld seam (11a) 103 Dividing the bag (10) into three chambers (16a-16c) by welding a first peel weld seam (14) and a second peel weld seam (15) 104 Welding the bag (10) in a tear-open bag (30) 105 Autoclaving the bag (10) arranged in the tear-open bag (30)
Claims
1. A bag (10) which is filled with a medical fluid and which is formed from two films which are welded to one another 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),wherein at least one withdrawal 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) up to the upper transverse weld seam (11b),wherein the second peel weld seam (15) extends from the lower transverse weld seam (11a) up to the second longitudinal weld seam (12b), andwherein the bag (10) is divided into three chambers (16a-16c) by a first peel weld seam (14) and a second peel weld seam (15), andwherein in the lower transverse weld (11a) are arranged at least three ports (20a-20c), each of which is connected to one of the three chambers (16a-16c).
2. The bag (10) filled with a medical fluid according to the preceding claim, characterised in that the second peel weld seam (15) runs via a first curve (15b) in the direction of the second longitudinal weld seam (12b) and / or in that the second peel weld seam (15) merges via a second curve (15d) into the second longitudinal weld seam (12b).
3. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in that the first peel weld seam (14) runs via a first, lower curve (14b) in the direction of the second peel weld seam (15) and is led back via a second, upper curve (14c) in the direction of the upper transverse weld seam (11b).
4. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in that an apex of the first curve (14b) of the first peel weld seam (14) is arranged lower than an apex of the first curve (15b) of the second peel weld seam (15).
5. The bag (10) filled with a medical fluid according to one of the precedingclaims, characterised in that an outer first chamber (16a) and / or a middle second chamber (16b) extend(s) from the lower transverse weld seam (11a) up to the upper transverse weld seam (11b) and / or in that an outer third chamber (16c) is delimited by the second peel weld seam (15), the lower transverse weld seam (11a) and the second longitudinal weld seam (12b).
6. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in that the first peel weld seam (14) comprises, below the first curve (14b), a lower straight section (14a), which in particular merges into the first curve (14b), and / or in that the first peel weld seam (14) comprises, above the second curve (14c), an upper straight section (14d), in particular wherein the second curve (14c) merges into the upper straight section (14d) in the direction of the upper transverse weld seam (11b).
7. The bag (10) filled with a medical fluid according to the preceding claim, characterised in that the lower straight section (14a) of the first peel weld seam (14) and / or the upper straight section (14d) of the first peel weld seam (14) run(s) substantially parallel to the longitudinal weld seam (12a, 12b).
8. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in that the second peel weld seam (15) comprises a lower straight section (15a) which, via the first curve (15b) of the first peel weld seam (15), merges into a region (15c) running transversely in the direction of the second longitudinal weld seam (12b).
9. The bag (10) filled with a medical fluid according to the preceding claim, characterised in that the first straight region (15a) of the second peel weld seam (15) runs substantially parallel to the longitudinal weld seams (12a, 12b) and / or in 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. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in that the bag (10) is divided by the first peel weld seam (14) and the second peel weld seam (15) into a right first chamber (16a), a middlesecond chamber (16b) and a left third chamber (16c).
11. The bag (10) filled with a medical fluid according to the preceding claim, characterised in that the right first chamber (16a) extends in the upper region only via the middle second chamber (16b), but not via the left third chamber (16c), and / or in that the second middle chamber (16b) extends in the upper region via the third left chamber (16c).
12. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in that the bag (10) is arranged sterile in a secondary package, in particular in a tear-open bag (30).
13. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in that the bag (10) is filled with 200 to 600 ml of medical fluid, in particular with 200 to 300 ml or with 400 to 600 ml of medical fluid.
14. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in that the bag (10) is designed in such manner that, when the bag (10) is rolled up from top to bottom, the first peel weld seam (14) can be initially torn open in a region between the first curve (14b) and the lower transverse weld seam (11a), and / or in that, when the bag (10) is rolled up from top to bottom, the second peel weld seam (15) can be initially torn open in a region between the first curve (15b) and the lower transverse weld seam (11a).
15. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in thatthe 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 medical fluid, and / orin 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 medical fluid, and / orin 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 medical fluid.
16. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in that the first peel weld seam (14) and / or the second peel weld seam (15) is or are designed in such manner that the films of a 30 mm long straight strip can be separated from one another with a force of between 10 and 30 N, preferably between 15 and 25 N, particularly preferably between 17.5 and 22.5 N.
17. The bag (10) filled with a medical fluid according to one of the preceding claims, characterised in that the bag (10) is designed for applications in paediatrics.
18. A method for producing a bag (10) filled with a medical fluid, comprising the steps:- Providing a first and a second film;- Welding the first and second films to form the bag (10), wherein at least one withdrawal port (20a) is welded in 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),and wherein the first peel weld seam (14) is welded in such manner that it runs starting 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 manner that it first runs upwards from the lower transverse weld seam (11a) and then changes the direction via a curve (15b) and ends at a long side of the bag (10),wherein in the lower transverse weld (11a) are arranged at least three ports (20a-20c), 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 fluid via respectively one port (20a-20c).
19. The method according to the preceding claim, characterised in that at least one 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 welding the lower transverse weld seam (11a) and / or after welding at least the second longitudinal weld seam (12b), and / or in that the chambers (16a-16c) of the bag(10) are filled with medical fluid via respectively one port (20a-20c) after welding the lower transverse weld seam (11a) and the peel weld seams (14, 15).
20. The method according to one of the preceding claims, characterised in that 5 at least the lower transverse weld seam (11a) and the peel weld seams (14, 15)are welded by means of a contact welding method and / or in that the bag (10) is packaged in a secondary package, in particular a tear-open bag (30), and is sterilised in the secondary package.10