Infusion Bags

Abstract

The present invention relates to a medical packaging designed as an infusion bag, the medical packaging consisting of mutually welded multilayer films and filled with medical liquid for infusion and / or parenteral nutrition. The present invention is described by a medical packaging designed as an infusion bag, the medical packaging consisting of mutually welded multilayer films and having at least one weld seam, the weld seam preferably being a longitudinal weld seam and a transverse weld seam, and the medical packaging being filled with medical liquid, wherein the multilayer film has at least one inner layer made of a matrix-phase-polymer system, an intermediate layer made of a matrix-phase-polymer system, and an outer layer made of a matrix-phase-polymer system, wherein the matrix polymers of the matrix-phase-polymer system of the inner layer, the intermediate layer, and the outer layer respectively include a polypropylene polymer (PP) having a defined mass fraction in each layer, and the phase polymers of the matrix-phase-polymer system of the inner layer, the intermediate layer, and the outer layer respectively include a styrene-ethylene / butylene-styrene block copolymer (SEBS) having a defined mass fraction in each layer. The film is characterized in that the styrene-ethylene / butylene-styrene block copolymer (SEBS) of the intermediate layer has a styrene-ethylene / butylene ratio (S / EB M ), and the outer layer of styrene-ethylene / butylene-styrene block copolymer (SEBS) has a styrene-ethylene / butylene ratio (S / EB A ), where S / EB A >S / EB M It has been shown that the mechanical properties of the multilayer film can be improved in this way, in particular when the multilayer film is stretched in the region of the weld seam. The improved mechanical properties are manifested both at room temperature and at lower temperatures of up to 4° C.

Description

Technical Field

[0001] The present invention relates to a medical package designed as an infusion bag, which is composed of a plurality of films welded to each other and is filled with a medical liquid for infusion or parenteral use. Background Art

[0002] Infusion bags made of multilayer films welded to one another are known. The infusion bags consist of films welded directly to one another and comprise at least one removal port. High requirements are placed on the infusion bags. Therefore, the infusion bags should be able to withstand a large degree of mechanical loads. At the same time, the films used for the infusion bags must be free of harmful substances. It is also generally required that the infusion bags can withstand heat sterilization, which is conventionally carried out at a temperature of 121° C.

[0003] In addition, PVC films are also used. However, multilayer films made of PP (polypropylene) are particularly suitable. The breaking strength can be increased in particular by varying the number of PP layers, i.e. by providing a multilayer PP film. Infusion bags made of multilayer ductile films have a high mechanical stability with respect to film tearing, since the films can yield under mechanical load. However, in the case of ductile films, it is more difficult to ensure high mechanical stability in the area of ​​the weld seam.

[0004] It is also known that the mechanical properties of PP films can be improved by providing a matrix-phase-polymer system. Here, for example, a thermoplastic elastomer can be distributed in the PP matrix. This increases the impact toughness of the material and thus improves the fracture strength of the multilayer composite material.

[0005] For example, US Pat. No. 5,783,269 A (Fresenius AG) shows a multilayer PP film. The layers of this film can contain styrene-ethylene / butylene-styrene block polymer copolymers (SEBS) or styrene-isoprene-styrene block polymer copolymers (SIS). This can improve the stability under impact loads and tensile loads. Multilayer PP films with SEBS are also described in the two patent applications WO 2011 / 128185 A1 and KR 2003 046120 A. Summary of the invention

[0006] The technical problem to be solved by the present invention is to improve the mechanical properties of a medical packaging designed as an infusion bag and based on polypropylene.

[0007] In particular, the technical problem to be solved by the present invention is to provide an infusion bag made of a multi-layer PP film, wherein the film has a high degree of extensibility in the weld seam area without tearing of the weld seam.

[0008] The technical problem to be solved by the present invention has been solved by a medical package designed as an infusion bag according to claim 1 .

[0009] Preferred embodiments of the invention are given in the dependent claims, the description and the drawings.

[0010] In general, the present invention is described as a medical package designed as an infusion bag, the medical package consisting of mutually welded multilayer films and having at least one weld seam, preferably having longitudinal and transverse weld seams, and filled with a medical liquid, wherein the multilayer film has at least one inner layer made of a matrix-phase-polymer system, an intermediate layer made of a matrix-phase-polymer system, and an outer layer made of a matrix-phase-polymer system, wherein the matrix polymers of the matrix-phase polymer system of the inner layer, the intermediate layer, and the outer layer respectively comprise a polypropylene polymer (PP), and the phase polymers of the matrix-phase polymer system of the inner layer, the intermediate layer, and the outer layer respectively comprise a styrene-ethylene / butylene-styrene block copolymer (SEBS), and wherein the styrene-ethylene / butylene-styrene block copolymer (SEBS) of the intermediate layer has a styrene-ethylene / butylene-styrene ratio of S / EB. M , and the outer layer of styrene-ethylene / butylene-styrene block copolymer (SEBS) has a styrene-ethylene / butylene ratio S / EB A , especially S / EB A > S / EB M .

[0011] According to claim 1, the present invention is described as a medical package designed as an infusion bag, the medical package consisting of mutually welded multilayer films and having at least one weld seam, and filled with a medical liquid, wherein the multilayer film has at least one inner layer made of a matrix-phase-polymer system, an intermediate layer made of a matrix-phase-polymer system, and an outer layer made of a matrix-phase-polymer system, wherein the matrix polymer of the matrix-phase-polymer system of the inner layer includes a mass fraction G in the range of 70% to 90% by mass IM The phase polymer of the matrix-phase-polymer system of the inner layer includes a mass fraction G in the range of 10% to 30% by mass. IP The matrix polymer of the matrix-phase-polymer system of the intermediate layer includes a mass fraction G in the range of 40% to 60% by mass. MM The mass fraction of the phase polymer in the matrix-phase-polymer system of the intermediate layer is G MPIn the range of 40% to 60% by weight and including styrene-ethylene / butylene-styrene block copolymer (SEBS), the matrix polymer of the matrix-phase-polymer system of the outer layer includes a mass fraction G in the range of 75% to 95% by weight AM The phase polymer of the matrix-phase-polymer system of the outer layer comprises a polypropylene polymer (PP) having a mass fraction G in the range of 5% to 25% by mass AP The styrene-ethylene / butylene-styrene block copolymer (SEBS) of the intermediate layer has a styrene-ethylene / butylene ratio S / EB M , and the outer layer of styrene-ethylene / butylene-styrene block copolymer (SEBS) has a styrene-ethylene / butylene ratio S / EB A , where S / EB A > S / EB M .

[0012] The medical packaging designed as an infusion bag consists of a plurality of films welded to one another and has at least one weld seam, preferably at least one longitudinal weld seam and at least one transverse weld seam, at which two multilayer films are welded to one another. In particular, the packaging comprises two longitudinal and two transverse weld seams.

[0013] The package designed as an infusion bag can also include at least one port for removing the medical liquid. In particular, the port is also welded with its lower part in a weld seam or in one of several weld seams, in particular in a transverse weld seam. The lower part of the port can be configured, for example, as a boat. The port can be a component of a connector, in which a sealing element is particularly arranged. For example, a needle, a lancet or a Luer lock connector can be connected to the connector.

[0014] The medical package may also include a hanger for attachment to a stent or an IV pole. The hanger may be specifically designed as a void or cutout in the transverse weld seam opposite the port.

[0015] The package according to the invention is filled with a medical liquid, for example with a saline solution.The package preferably comprises a capacity of 50 to 1000 ml, in particular each chamber comprises a capacity of 50 to 1000 ml.

[0016] The multilayer film used for packaging is a film based on polypropylene. The film is a film with polypropylene as the main component, and the polypropylene forms a PP matrix as described below. The film is preferably free of PVC.

[0017] The multilayer film has at least three layers, preferably exactly three layers. These layers are connected to each other in a material-bonded manner. In particular, these layers are connected to each other by coextrusion and butt-jointing in a hot state.

[0018] The multilayer film comprises at least one inner layer made of a matrix-phase-polymer system, an intermediate layer made of a matrix-phase-polymer system and an outer layer made of a matrix-phase-polymer system.

[0019] The inner layer is in contact with the medical fluid, and the outer layer is the surface of the medical packaging designed as an infusion bag.

[0020] In the case of matrix-phase-polymer systems, at least two different polymers are present, one of which is present in a dissociated state, in particular in the form of dispersedly distributed solidified droplets, within a matrix of the other polymer.

[0021] The matrix polymer of the matrix-phase-polymer system of the inner layer, the middle layer and the outer layer comprises a polypropylene polymer in each case. The matrix consists in particular of polypropylene.

[0022] The phase polymer of the matrix-phase-polymer system of the inner layer, the middle layer and the outer layer each comprises at least one styrene-ethylene / butylene-styrene block copolymer (SEBS) as the phase polymer.

[0023] SEBS is a block polymer consisting of a styrene portion, a butylene portion and an ethylene portion, which includes a hydrogenated butadiene portion to which a styrene group is attached. SEBS is made in particular by polymerizing styrene and butadiene monomers and then hydrogenating the previously polymerized SBS. The hydrated butadiene forms a soft mid-block between the styrene blocks. SEBS forms a good connection with the PP matrix polymer.

[0024] The styrene-ethylene / butylene-styrene block copolymer (SEBS) of the middle layer has a styrene-ethylene / butylene ratio of S / EB. M The outer layer of styrene-ethylene / butylene-styrene block copolymer (SEBS) has a styrene-ethylene / butylene ratio of S / EB. A The styrene-ethylene / butylene ratio is accordingly the mass fraction of styrene divided by the mass fraction of the sum of ethylene and butylene.

[0025] The weight ratio of styrene to the sum of ethylene and butene can be determined by determining the weight of styrene monomer and butadiene monomer consumed by polymerization. After polymerization, the styrene content can be determined using UV spectroscopy. After extracting and dissolving the sample, the measurement can be performed using a UV spectrometer. The content of the relevant styrene is calculated by using a calibration curve with the aid of an absorption peak at an absorption wavelength corresponding to the styrene component.

[0026] According to the present invention, S / EB A >S / EB M The middle layer has a higher butene / ethylene content than the outer layers.

[0027] It has been shown that this can significantly improve the mechanical properties of the multilayer film, in particular when the multilayer film is stretched in the region of the weld seam.

[0028] In particular, it is possible to extend the sterilizing multilayer film also in the region of its weld seam, preferably in the region of its longitudinal weld seam, to at least 150%, preferably at least 200% of its length without the film being torn in the region of the weld seam.

[0029] The maximum extension of the non-sterile, unfused multilayer film itself (breaking strain according to DIN EN ISO 527 (Edition 2012-06)) is preferably greater than 500%, particularly preferably greater than 600% and / or less than 800%.

[0030] The tensile strength of the non-sterile multilayer film itself is preferably higher than 20 N / mm 2 and / or less than 40 N / mm 2 .

[0031] The non-sterile multilayer film has a measurable tensile limit. The tensile limit (measured according to DIN EN ISO 527) is preferably higher than 5 N / mm 2 , particularly preferably above 6 N / mm 2 and / or less than 15 N / mm 2 The elongation when reaching the yield point is preferably higher than 10%, particularly preferably higher than 15% and / or lower than 30%.

[0032] After heat sterilization, the tensile limit of films designed as packaging for infusion bags cannot be determined. The maximum extension of the sterilized multilayer film itself (breaking strain according to DIN EN ISO 527 (Edition 2012-06)) is preferably greater than 400%, particularly preferably greater than 500% and / or less than 700%. The tensile strength of the sterilized multilayer film is preferably greater than 20 N / mm 2 and / or less than 40 N / mm 2 Improvements in the mechanical properties of the sterilization bags were demonstrated at room temperature and at lower temperatures up to 4°C.

[0033] Without being bound by theory, the distribution of SEBS within the PP matrix, in addition to the softer material of the middle layer, is responsible for the improved mechanical properties.

[0034] In one embodiment of the present invention, the styrene-ethylene / butylene-styrene block polymer of the inner layer has a styrene-ethylene / butylene ratio S / EBI , where S / EB I >S / EB M There is also provided an inner layer having a lower butene / ethylene content than the middle layer.

[0035] According to one embodiment of the present invention, S / EB A >1.2 S / EB M , preferably S / EB A >1.5 S / EB M , and / or S / EB I >1.2 S / EB M , preferably S / EB I >1.5 S / EB M , and / or S / EB I = S / EB A . Preferably, S / EB A <2.0 S / EB M and / or S / EB I <2.0 S / EB M .

[0036] The SEBS used for the middle layer is preferably softer than the SEBS used for the inner layer and / or the outer layer. In particular, the middle layer or the SEBS of the middle layer has a Shore A hardness of less than 50, preferably less than 45, and / or greater than 30 (measured according to DIN EN ISO 868 (Edition 2003-10) and DIN ISO 7619-1 (Edition 2012-02)).

[0037] The Shore A hardness of SEBS used for the inner layer and / or the outer layer may be greater than 55, preferably greater than 62, and / or less than 80.

[0038] In one embodiment of the present invention, the ratio S / EB of the intermediate layer M Less than 0.16, preferably less than 0.14, and / or greater than 0.10, preferably greater than 0.13. SEBS polymers with such properties are available, for example, under the trade name AsahiTuftec® H1221.

[0039] In one embodiment of the present invention, the ratio S / EB of the inner layer I and / or the ratio S / EB of the outer layer A Greater than 0.18, preferably greater than 0.20, and / or less than 0.28, preferably less than 0.24. SEBS polymers with such properties are available, for example, under the trade name Asahi Tuftec® H1062.

[0040] In a development of the invention, the phase polymer of the matrix-phase-polymer system of the intermediate layer additionally comprises a styrene-isoprene-styrene block copolymer (SIS).

[0041] In particular, providing a mass fraction G MP1 Styrene-ethylene / butylene-styrene block copolymer (SEBS) and mass fraction G MP2 Styrene-isoprene-styrene block polymer (SIS), where G MP1 > 3 G MP2 and / or G MP1 <5G MP2 .

[0042] According to another embodiment of the present invention, the matrix polymer of the middle layer is a polypropylene random copolymer. This is well combined with SEBS with a high butene / ethylene content and helps to form a soft middle layer.

[0043] According to one embodiment, the matrix polymer in the intermediate layer has a mass fraction G MM , which basically corresponds to the mass fraction of the phase polymer G MP Or the mass fraction of several phase polymers G MP1+2 In particular, G MM = (0.9-1.1) G MP1+2 or G MM = (0.9-1.1) G MP In particular, G MP It's G MP1 and G MP2 The sum of .

[0044] According to one embodiment of the invention, the matrix polymer of the outer layer is not a PP random copolymer, but a polypropylene homopolymer. In this way, a strong outer layer of the layer packaging is achieved.

[0045] The softening temperature (Vicat softening temperature A / 50 / N) of the polypropylene used for the outer layer is preferably higher than the softening temperature of the polypropylene used for the middle layer and / or inner layer. In particular, the softening temperature of the polypropylene of the outer layer is at least 10°C higher, preferably at least 15°C higher than that of the polypropylene of the middle layer.

[0046] The Vicat softening temperature A / 50 / N (measured in accordance with DIN EN ISO 306 (edition 2014-03)) of the PP of the outer layer is preferably above 140°C, particularly preferably above 150°C and / or below 170°C.

[0047] The films according to the invention exhibit good weldability and good stability with respect to thermal sterilization, in particular with respect to autoclaving.

[0048] Preferably, the PP polymer for the outer layer is at least harder than the PP polymer for the middle layer. According to one embodiment of the invention, the PP polymer for the outer layer has a ball pressure hardness H 358 / 30 greater than 55 MPa, preferably greater than 60 MPa and / or less than 80 MPa (according to DIN 53505 (2000-08 edition) / ISO 2039 (2003-06 edition)). The PP for the middle layer and / or the inner layer may have a ball pressure hardness H 358 / 30 less than 60 MPa, preferably less than 50 MPa and / or greater than 35 MPa.

[0049] In the outer layer, the matrix polymer preferably has a mass fraction G AM , and the phase polymer has a mass fraction G AP , where G AM > 4 G AP .

[0050] According to one embodiment of the present invention, the matrix polymer in the inner layer has a mass fraction G IM , the phase polymer has a mass fraction G IP , where G IM >3 G IP In particular, the mass fraction of the matrix polymer in the inner layer G IM In the range of 70% to 90% by mass, and the mass fraction of the phase polymer G IP In the range of 10% to 30% by mass.

[0051] The matrix polymer of the inner layer is also preferably a polypropylene random copolymer.

[0052] In the outer layer, the matrix polymer has a mass fraction G AM , and the phase polymer has a mass fraction G AP , where preferably G AM >4G AP .

[0053] In the outer layer, the mass fraction of the matrix polymer G AM Preferably, the mass fraction of the phase polymer G is in the range of 75% to 95% by mass. AP In the range of 5% to 25% by mass.

[0054] Preferably, the mass fraction of the phase polymer in the middle layer is MP1+2 The mass fraction of the phase polymer relative to the outer layer G AP Increase, where G MP1+2 >3 G AP and / or G MP1+2 <5 G AP.

[0055] In the middle layer, the mass fraction of the matrix polymer G MM Preferably, the mass fraction G of the phase polymer is in the range of 40% to 60% by mass. MP Or the mass fraction of several phase polymers G MP1+2 In the range of 40% to 60% by mass. In one embodiment, G MP Preferably at least G MP1 and G MP2 composition.

[0056] In particular, the mass fraction G of styrene-ethylene / butylene-styrene block copolymer (SEBS) as the phase polymer in the middle layer is MP1 In the range of 30 to 55% by mass, and / or the mass fraction G of styrene-isoprene-styrene block polymer (SIS) as an additional phase polymer MP2 In the range of greater than or equal to 0% to 20% by mass.

[0057] According to one embodiment of the present invention, the inner layer has a thickness D I , the middle layer has a thickness D M , and the outer layer has a thickness D A , of which 4 D I <D M <5 D A and / or 4D A <D M <5 D I .

[0058] The total thickness of the multilayer film used for packaging is preferably greater than 150 μm, particularly preferably greater than 180 μm and / or less than 250 μm, particularly preferably less than 220 μm.

[0059] The thickness of the inner layer and / or outer layer of the multilayer film is preferably greater than 15 μm, particularly preferably greater than 25 μm and / or less than 45 μm, particularly preferably less than 35 μm.

[0060] The thickness of the intermediate layer is preferably greater than 100 μm, particularly preferably greater than 120 μm and / or less than 170 μm, particularly preferably less than 150 μm, in particular 125 μm to 145 μm.

[0061] According to the present invention, the medical packaging is designed as an infusion bag filled with a medical liquid. The medical liquid is a liquid used for medical purposes and is preferably administered intravenously. Therefore, in a preferred embodiment, the medical liquid is an infusion solution. Possible examples of such infusion solutions include:

[0062] - Sterile water;

[0063] - salt solutions, in particular solutions containing NaCl, KCl, CaCl and / or Mg;

[0064] - solutions containing carbohydrates, in particular glucose solutions;

[0065] - solutions, emulsions and / or suspensions with nutrients for parenteral nutrition, in particular with lipids, amino acids and / or glucose;

[0066] - colloid solutions, in particular those used in blood replacement therapy (e.g. Voluven®); and / or

[0067] - So-called premixed systems, to which the active ingredient (eg paracetamol) is already added to the medicinal liquid.

[0068] Medical packaging designed as an infusion bag filled with medical liquid can also be called a pharmaceutical product.

[0069] The medical packaging designed as an infusion bag preferably has a capacity of 50 ml to 1000 ml, for example, if the infusion bag is designed as a multi-chamber bag, its total capacity can also be up to 3000 ml. Therefore, according to one embodiment, the infusion bag can be designed as a three-chamber bag for parenteral nutrition. Each chamber contains a component (lipid, amino acid or glucose). The three chambers are initially separated from each other, for example by internal tearable seams. Before administering the nutritional composition, these internal seams for separation are torn and the components are mixed with each other.

[0070] The features of the medical packaging designed as an infusion bag mentioned above in the specification (the infusion bag is composed of multiple layers of films welded to each other and has at least one weld seam and is filled with a medical liquid) and the features described in the claims are also the features of the weldable film described below and / or the features of the welding process described below.

[0071] The invention can also be described by a weldable film, in particular a weldable film for medical packaging designed as an infusion bag as described above. The film is a multilayer film, wherein the multilayer film has at least one inner layer made of a matrix-phase polymer system, an intermediate layer made of a matrix-phase polymer system and an outer layer made of a matrix-phase polymer system, wherein the matrix polymer of the matrix-phase polymer system of the inner layer, the intermediate layer and the outer layer respectively comprises a polypropylene polymer (PP), and the phase polymer of the matrix-phase polymer system of the inner layer, the intermediate layer and the outer layer respectively comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS), characterized in that the styrene-ethylene / butylene-styrene block copolymer (SEBS) of the intermediate layer has a styrene-ethylene / butylene ratio of 1:1. M The outer layer of styrene-ethylene / butylene-styrene block copolymer (SEBS) has a styrene-ethylene / butylene ratio S / EB A , where S / EB A > S / EB M .

[0072] The film is processed by a welding method, such as an impulse welding method, for producing a medical packaging designed as an infusion bag from a multilayer film, wherein the multilayer film has at least one inner layer made of a matrix-phase polymer system, an intermediate layer made of a matrix-phase polymer system and an outer layer made of a matrix-phase polymer system, wherein the matrix polymer of the matrix-phase polymer system of the inner layer, the intermediate layer and the outer layer respectively comprises a polypropylene polymer (PP), and the phase polymer of the matrix-phase polymer system of the inner layer, the intermediate layer and the outer layer respectively comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS), characterized in that the styrene-ethylene / butylene-styrene block copolymer (SEBS) of the intermediate layer has a styrene-ethylene / butylene block copolymer ratio of S / EB. M The outer layer of styrene-ethylene / butylene-styrene block copolymer (SEBS) has a styrene-ethylene / butylene ratio S / EB A , where S / EB A > S / EB M .

[0073] The invention makes it possible to provide an improved packaging made of a multilayer PP film. The film has a high degree of ductility in the region of the weld seam without tearing at the weld seam or in the region of the weld seam.

[0074] The PP content of the multilayer film is preferably higher than 55% by mass, particularly preferably higher than 60% by mass, and / or lower than 70% by mass, particularly preferably lower than 65% by mass. BRIEF DESCRIPTION OF THE DRAWINGS

[0075] The following is by reference Figure 1 and Figure 2 The schematically illustrated exemplary embodiments explain the subject matter of the invention in more detail.

[0076] Figure 1 A medical package designed as an infusion bag is shown.

[0077] Figure 2 It is a schematic cross-sectional view of a multi-layer PP film used for an infusion bag. DETAILED DESCRIPTION

[0078] Figure 1 A medical package designed as an infusion bag 1 is shown.

[0079] The infusion bag 1 is made of two multilayer films 8 welded to each other. The multilayer films 8 are connected to each other via longitudinal weld seams 7 and transverse weld seams 6, so that a bag filled with medical fluid is formed. The bag 1 is a single-chamber bag here.

[0080] The multilayer film 8 is connected to one another, for example, by an impulse welding method. In this case, the film 8 is welded by means of a welding tool with heatable sealing strips in contact with the film, which is performed by temporarily heating the sealing strips so that the film sandwiched between the sealing strips at least partially melts and is thus welded. For example, the impulse welding method is described in the publication EP 0 911 141 A2 (Fresenius MedicalCare Deutschland GmbH).

[0081] The infusion bag 1 comprises at least one port, in this embodiment comprises two ports 2a, 3a, wherein one port 2a is used for filling with liquid, for example, dosing of medicine, and the other port 3a is used for taking out medical liquid.

[0082] In this embodiment, the ports 2a, 3a comprise weld boats, with which the ports 2a, 3a are welded in the region 5 of the transverse weld seam 6.

[0083] The two ports 2a and 3a provide the lower part of the connector 2 and 3 respectively. The two connectors 2 and 3 are formed by the two lower parts 2a and 3a and the upper parts 2b and 3b respectively. The upper parts 2b and 3b are preferably placed on the lower parts 2a and 3a, especially bumped on the lower parts 2a and 3a. The sealing element (not shown in the figure here) that closes the channel in the port 2a and 3a or the channel in the connector 2 and 3 relative to the bag space is preferably included between the corresponding lower part 2a, 3a and the upper parts 2b and 3b in a shape-fitting manner. The sealing element is a self-closing, reclosable elastomeric element that can be pierced with a lancet and / or a needle to remove or supply liquid. After the lancet and / or the needle are pulled out, the sealing element is automatically closed. Polyisoprene can be used as an elastomeric material, for example. In addition, the upper parts 2b and 3b of the connectors 2 and 3 respectively include a covering member covering the sealing element, and the covering member is preferably a breakable cover 2c and 3c. The respective sealing element is therefore only accessible after the cover 2c, 3c has been removed or broken off.

[0084] Furthermore, the infusion bag 1 comprises a hanging piece 4 on the side opposite to the at least one port 2a, 3a for attaching the infusion bag to an infusion stand or a bracket. The hanging piece 4 can be designed as a cutout or a punch hole in the transverse weld seam 6.

[0085] Figure 2 Schematic diagram of a multilayer film 8 used in an infusion bag 1 .

[0086] The film 8 is composed of an inner layer 9c, an intermediate layer 9b and an outer layer 9a, which are in contact with the medical fluid. When the film 8 is welded, the layers 9a, 9b, 9c become molten liquid. Here, for example, in the case of impulse welding, all materials in the weld seam area are converted into molten liquid.

[0087] The thickness of the inner and outer layers 9c, 9a is 25 to 45 μm, respectively. The thickness of the intermediate layer 9b is 125 to 145 μm.

[0088] The outer layer 9a is made of PP homopolymer, to which SEBS is added to improve the mechanical properties. The mass fraction of PP homopolymer G AM In the range of 82% to 88% by mass. AP In the range of 12% to 18% by mass.

[0089] The inner layer 9c is made of PP random copolymer, to which SEBS is added to improve the mechanical properties. IM In the range of 77% to 83% by mass. IP In the range of 17% to 23% by mass.

[0090] The middle layer 9b is at least softer than the outer layer 9a. The middle layer 9b is also preferably softer than the inner layer 9c. The middle layer 9b is made of a PP random copolymer that is softer than the PP of the outer layer 9a, to which SEBS and optionally SIS are added. The mass fraction of the PP random copolymer G MM In the range of 47% to 53% by mass. MP1 The mass fraction G of the second thermoplastic elastomer SIS is in the range of 37% to 43% by mass. MP2 In the range of 7% to 13% by mass. The mass fraction of the thermoplastic elastomer (ie SEBS and optionally SIS) in the middle layer 9b is higher than that in the inner and outer layers 9a, 9c.

[0091] Furthermore, the SEBS in the middle layer 9b has a higher ethylene / butylene mass fraction than the SEBS in the inner and outer layers 9a, 9c. M The ratio S / EB in the outer layer 9a and / or the inner layer 9c is 12 / 88. A It is 18 / 82.

[0092] This provides a soft middle layer 9b with a finer distribution of SEBS than the inner and outer layers 9c, 9a, which greatly improves the mechanical properties of the infusion bag, in particular in the drop test. This improved mechanical properties are exhibited at room temperature and at lower temperatures of up to 4°C.

[0093] The film 8 is produced by coextrusion of the individual layers 9a - 9c .

[0094] The invention makes it possible in a simple manner to improve the mechanical properties of the infusion bag 1 , in particular in the region of the weld seams 6 , 7 and over a wide temperature range.

[0095] Reference numerals list

[0096] 1 Infusion bag

[0097] 2 Connectors for supplying additives or medications

[0098] 2a The lower part or port of the connector

[0099] 2b Upper part of the connector

[0100] 2c Upper broken part

[0101] 3 Connectors for removing medical fluids

[0102] 3a The lower part or port of the connector

[0103] 3b Upper part of the connector

[0104] 3c Upper broken part

[0105] 4 Suspension parts

[0106] 5 Weld seam area

[0107] 6 Transverse weld seam

[0108] 7 Longitudinal weld seam

[0109] 8 films

[0110] 9a Outer layer

[0111] 9b Middle Layer

[0112] 9c Inner layer

Claims

1. A medical package designed as an infusion bag (1), the medical package consisting of a plurality of films (8) welded to each other and having at least one weld seam (6, 7), and the medical package being filled with a medical liquid, in, The multilayer film (8) comprises an inner layer (9c) made of a matrix-phase-polymer system, an intermediate layer (9b) made of a matrix-phase-polymer system, and an outer layer (9a) made of a matrix-phase-polymer system. wherein the matrix polymer of the matrix-phase-polymer system of the inner layer (9c), the middle layer (9b) and the outer layer (9a) respectively comprises a polypropylene polymer (PP), and The phase polymers of the matrix-phase-polymer systems of the inner layer (9c), the intermediate layer (9b) and the outer layer (9a) respectively comprise styrene-ethylene / butylene-styrene block copolymers, The outer layer (9a) is composed of a polypropylene homopolymer added with a styrene-ethylene / butylene-styrene block copolymer, wherein the mass fraction of the polypropylene homopolymer is G AM In the range of 82-88% by mass, the mass fraction G of the styrene-ethylene / butylene-styrene block copolymer is AP In the range of 12-18% by mass; Wherein, the intermediate layer (9b) is composed of a polypropylene random copolymer added with styrene-ethylene / butylene-styrene block copolymer and styrene-isoprene-styrene block copolymer, and the mass fraction of the polypropylene random copolymer is G MM In the range of 47-53% by mass, the mass fraction G of the styrene-ethylene / butylene-styrene block copolymer is MP1 In the range of 37-43%, the weight fraction G of the styrene-isoprene-styrene block copolymer (SIS) MP2 In the range of 7-13%; Wherein, the inner layer (9c) is composed of a polypropylene random copolymer added with a styrene-ethylene / butylene-styrene block copolymer, and the mass fraction of the polypropylene random copolymer is G IM In the range of 77-83% by mass, the mass fraction G of the styrene-ethylene / butylene-styrene block copolymer is IP In the range of 17–23% by mass, The styrene-ethylene / butylene-styrene block copolymer of the intermediate layer (9b) has a styrene-ethylene / butylene ratio S / EB M , and the styrene-ethylene / butylene-styrene block copolymer of the outer layer (9a) has a styrene-ethylene / butylene ratio S / EB A , where S / EB A > S / EB M , The ratio S / EB of the intermediate layer (9b) M The styrene-ethylene / butylene-styrene block polymer of the inner layer (9c) has a styrene-ethylene / butylene ratio S / EB of less than 0.16 and greater than 0.

10. I , the ratio S / EB of the inner layer (9c) I and / or the ratio S / EB of the outer layer (9a) A Greater than 0.18 and less than 0.

28.

2. The medical packaging designed as an infusion bag (1) according to the preceding claim, characterized in that S / EB I >S / EB M , 3. The medical packaging designed as an infusion bag (1) according to claim 1 or 2, characterized in that: S / EB A > 1.2S / EB M and / or S / EB I > 1.2 S / EB M .

4. The medical packaging designed as an infusion bag (1) according to claim 1 or 2, characterized in that: The ratio S / EB in the middle layer (9b) M is 12 / 88, and the ratio S / EB in the outer layer (9a) A is 18 / 82, and the ratio S / EB in the inner layer (9c) I It is 18 / 82.

5. The medical packaging designed as an infusion bag (1) according to claim 1 or 2, characterized in that: Providing a mass fraction of G in the intermediate layer (9b) MP1 Styrene-ethylene / butylene-styrene block copolymer and mass fraction G MP2 Styrene-isoprene-styrene block polymer, wherein G MP1 > 3 G MP2 and / or G MP1 <5 G MP2 .

6. The medical packaging designed as an infusion bag (1) according to claim 1 or 2, characterized in that: In the intermediate layer (9b), the matrix polymer has a mass fraction G MM , the mass fraction G MM Mass fraction of the phase polymer G MP Satisfy relationship G MM = (0.9-1.1)G MP .

7. The medical packaging designed as an infusion bag (1) according to claim 1 or 2, characterized in that: The inner layer (9c) has a thickness D I , the intermediate layer (9b) has a thickness D M , and the outer layer (9a) has a thickness D A , of which 4 D I <D M <5 D A and / or 4D A <D M <5 D I .

8. The medical packaging designed as an infusion bag (1) according to claim 1 or 2, characterized in that: The thickness of the inner layer (9c) and the outer layer (9a) is 25 to 45 μm respectively, and the thickness of the intermediate layer (9b) is 125 to 145 μm.

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