Infusion bag

Abstract

The present invention relates to a medical package designed as an infusion bag, which is made of a multilayer film welded together and is filled with a medicinal solution for infusion and / or parenteral nutrition. The invention is illustrated by a medical package designed as an infusion bag filled with a medicinal solution, made of a film with multiple layers welded together and having at least one weld seam, preferably a longitudinal and a transverse weld seam. The multilayer film has at least one inner layer of a matrix phase polymer system, an intermediate layer of a matrix phase polymer system, and an outer layer of a matrix phase polymer system. The matrix polymer of the matrix phase polymer system of the inner, intermediate, and outer layers comprises, in each case, a polypropylene polymer (PP) having a specified weight part in each phase, and the phase polymer of the matrix phase polymer system of the inner, intermediate, and outer layers comprises, in each case, a styrene-ethylene / butylene-styrene block copolymer (SEBS) having a specified weight part 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 styrene-ethylene / butylene-styrene block copolymer (SEBS) of the outer layer has a styrene-ethylene / butylene ratio (S / EB A ) and S / EB A >S / EB M It has been shown that the mechanical properties of the multilayer film can be improved in this way, especially when stretching the multilayer film in the region of the welded seam. The improved mechanical properties are present both at room temperature and at temperatures as low as 4°C. [Selected Figure] Figure 1

Description

[Technical Field]

[0001] The present invention relates to a medical package designed as an infusion bag, which is made from a film with several layers welded together and is filled with a medicinal solution for infusion or parenteral nutrition. [Background technology]

[0002] Infusion bags are known that consist of films with multiple layers welded together. These films are directly welded together and include at least one outlet port. The requirements for infusion bags are high. Therefore, they must be able to withstand a significant amount of mechanical stress. At the same time, the films used for this purpose must be free of contaminants. Another requirement is that the bags be able to be subjected to heat sterilization, typically at a temperature of 121°C.

[0003] Among other things, PVC films are used. However, multilayer films of PP (polypropylene) are particularly suitable. The tear resistance can be increased in particular by different layers of PP, i.e., by providing a multilayer PP film. Infusion bags made of multilayer flexible films have high mechanical stability with respect to film tearing, since the film can bend under mechanical load. However, in the case of flexible films, it is more difficult to ensure high mechanical stability in the area of the welded seam.

[0004] It is also known that the mechanical properties of PP films can be improved by providing a matrix phase polymer system, in which a thermoplastic elastomer can be distributed in the PP matrix, etc. This increases the impact strength of the material and improves the tear resistance of multilayer composites.

[0005] For example, Patent Document 1 (Fresenius AG) presents a multilayer PP film, the layers of which may contain styrene-ethylene / butylene-styrene block copolymer (SEBS) or styrene-isoprene-styrene block copolymer (SIS). In this way, stability in the event of impact and tensile loads can be improved. Multilayer PP films containing SEBS are also described in two patent applications: Patent Document 2 and Patent Document 3. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 5,783,269 [Patent Document 2] International Publication No. 2011 / 128185 [Patent Document 3] Korean Patent Application Publication No. 2003 046120 Summary of the Invention [Problem to be solved by the invention]

[0007] The underlying objective of the present invention is to improve the mechanical properties of medical packaging designed as polypropylene-based infusion bags.

[0008] In particular, it is an object of the present invention to provide an infusion bag made of a multilayer PP film, which has high flexibility in the area of the welded seam and which prevents the welded seam from tearing. [Means for solving the problem]

[0009] The object of the present invention has already been achieved by a medical package designed as an infusion bag as claimed in claim 1.

[0010] Preferred embodiments of the invention can be inferred from the subject matter of the dependent claims, the description and the drawings.

[0011] The present invention generally relates to a medical package designed as an infusion bag, made of a film with several layers welded together, having at least one weld seam, preferably both longitudinal and transverse weld seams, filled with a medicinal solution, The multilayer film has at least one inner layer of a matrix phase polymer system, an intermediate layer of a matrix phase polymer system, and an outer layer of a matrix phase polymer system, wherein the matrix polymer of the matrix phase polymer systems of the inner layer, the intermediate layer, and the outer layer each comprises a polypropylene polymer (PP); the phase polymer of the matrix phase polymer system of the inner layer, the intermediate layer, and the outer layer each comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS); The styrene-ethylene / butylene-styrene block copolymer (SEBS) in the middle layer has a styrene-ethylene / butylene ratio (S / EB M ), and the styrene-ethylene / butylene-styrene block copolymer (SEBS) of the outer layer has a styrene-ethylene / butylene ratio (S / EB A ), especially S / EB A >S / EB M This is illustrated by the medical packaging.

[0012] According to claim 1, the invention provides a medical package designed as an infusion bag, made of a film with several layers welded together, having at least one welded seam, and filled with a medicinal solution, The multilayer film has at least one inner layer of a matrix phase polymer system, an intermediate layer of a matrix phase polymer system, and an outer layer of a matrix phase polymer system; The matrix polymer of the matrix phase polymer system of the inner layer has a weight percentage G in the range of 70% by weight to 90% by weight. IM and containing polypropylene polymer (PP), The matrix phase polymer of the inner layer has a weight percentage G in the range of 10% by weight to 30% by weight. IP and a styrene-ethylene / butylene-styrene block copolymer (SEBS), The matrix polymer of the matrix phase polymer system of the intermediate layer has a weight ratio G in the range of 40 wt% to 60 wt%. MM and containing polypropylene polymer (PP), Weight ratio G of the phase polymer of the matrix phase polymer system of the intermediate layer (9b) MP is in the range of 40% to 60% by weight and includes styrene-ethylene / butylene-styrene block copolymer (SEBS); The matrix polymer of the matrix phase polymer system of the outer layer has a weight percentage G in the range of 75% by weight to 95% by weight. AM and containing polypropylene polymer (PP), The phase polymer of the matrix phase polymer system of the outer layer has a weight percentage G of the phase polymer in the range of 5 wt% to 25 wt%. AP The styrene-ethylene / butylene-styrene block copolymer (SEBS) in the middle layer has a styrene-ethylene / butylene ratio (S / EB M ), and the styrene-ethylene / butylene-styrene block copolymer (SEBS) of the outer layer has a styrene-ethylene / butylene ratio (S / EB A ) and S / EB A >S / EB M This is illustrated by the medical packaging.

[0013] A medical package designed as an infusion bag is made of a film having multiple layers welded together and has at least one weld seam, preferably at least one longitudinal and at least one transverse weld seam, along which two multi-layer films are welded together.

[0014] In particular, the package comprises two longitudinal weld seams and two transverse weld seams.

[0015] Furthermore, a package designed as an infusion bag can further comprise at least one port for discharging the medicinal solution. The port is particularly welded at its lower part to a welded seam or to one of the welded seams, particularly a transverse welded seam. The lower part of the port can be, for example, in the shape of a shuttle. The port can be part of a connector, in particular in which a sealing element is arranged. For example, a needle, a spike or a luer lock connector can be connected to the connector.

[0016] The medical package may further comprise a hanger for attachment to a rack or an IV stand. The hanger may in particular be designed as a recess or indentation in the lateral weld seam opposite the port.

[0017] The package according to the invention is filled with a medicinal solution, for example with saline solution, and preferably has a storage volume of between 50 ml and 1000 ml, in particular per chamber.

[0018] The multilayer film used for packaging is a polypropylene-based film, which is a film containing polypropylene as the main component, specifically forming a PP matrix, as described below. The film preferably does not contain PVC.

[0019] A multilayer film has at least three, preferably exactly three, layers that are bonded to one another in a materially bonded manner, in particular by coextrusion at elevated temperatures to form a joint.

[0020] 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.

[0021] The inner layer is in contact with the medical solution, and the outer layer is the surface of the medical package designed as an infusion bag.

[0022] In matrix phase polymer systems, at least two different polymers are present, one of which exists segregated, particularly as dispersed rigid drops, in a matrix of the other polymer.

[0023] The matrix polymer of each of the matrix phase polymer systems of the inner layer, the intermediate layer, and the outer layer includes a polypropylene polymer, and the matrix is particularly made of polypropylene.

[0024] The phase polymers of the matrix phase polymer systems of the inner, intermediate and outer layers each include at least one styrene-ethylene / butylene-styrene block copolymer (SEBS) as the phase polymer.

[0025] SEBS is a block copolymer composed of styrene, butylene, and ethylene moieties, including a hydrogenated butadiene moiety flanked by styrene groups. It is typically produced by polymerization of styrene and butadiene monomers and subsequent hydrogenation of prepolymerized SBS. The hydrated butadiene forms a soft midblock between the styrene blocks. SEBS bonds well with PP matrix polymers.

[0026] The styrene-ethylene / butylene-styrene block copolymer (SEBS) in the middle layer has a styrene-ethylene / butylene ratio of S / EB M The styrene-ethylene / butylene-styrene block copolymer (SEBS) of the outer layer has a styrene-ethylene / butylene ratio of S / EB A The styrene-ethylene / butylene ratio is in each case the weight proportion of styrene divided by the weight proportion of ethylene plus butylene.

[0027] The weight ratio of styrene to the sum of ethylene and butylene can be determined by determining the weights of the styrene and butadiene monomers used in the polymerization. After polymerization, the styrene content can be determined using UV spectroscopy. After extracting and dissolving the sample, measurements can be performed with a UV spectrometer. The percentage of bound styrene is calculated by the peak absorbance at the absorption wavelength assigned to the styrene component using a calibration curve.

[0028] According to the present invention, S / EB A >S / EB M Therefore, the middle layer has a higher butylene / ethylene ratio than the outer layer.

[0029] In this way it has been shown that the mechanical properties of the multilayer film can be significantly improved, especially in the case of elongation of the multilayer film in the region of the welded seam.

[0030] In particular, in the case of a sterile multilayer film, it was also possible to stretch the film in the region of the weld seam, preferably the longitudinal weld seam, by at least 150%, preferably at least 200%, of its length without tearing the film in the region of the weld seam.

[0031] The maximum elongation (elongation at break according to DIN EN ISO 527 (version 2012-06)) of the unsterilized, unwelded multilayer film alone is preferably more than 500%, particularly preferably more than 600% and / or less than 800%. The tensile strength of the unsterilized multilayer film alone is preferably 20 N / mm 2 Over and / or 40N / mm 2 is less than.

[0032] The multi-layer non-sterile film has a measurable yield strength. The yield strength (measured according to DIN EN ISO 527) is preferably 5 N / mm 2 More than 6 N / mm 2 Over and / or 15N / mm 2The elongation when the yield strength is reached is preferably more than 10%, particularly preferably more than 15% and / or less than 30%.

[0033] After heat sterilization, the yield strength cannot be determined for films of packages designed as infusion bags. The maximum elongation (elongation at break according to DIN EN ISO 527 (version 2012-06)) of the sterilized multilayer film alone is preferably more than 400%, particularly preferably more than 500% and / or less than 700%. The tensile strength of the sterilized multilayer film is preferably 20 N / mm 2 Over and / or 40N / mm 2 The improved mechanical properties for the sterilization bags are exhibited both at room temperature and at temperatures as low as 4°C.

[0034] In addition to the soft material in the interlayer, the distribution of SEBS within the PP matrix may be responsible for the improved mechanical properties, without being bound by theory.

[0035] In one embodiment of the present invention, the styrene-ethylene / butylene-styrene block copolymer of the inner layer has a styrene-ethylene / butylene ratio S / EB I and S / EB I >S / EB M Therefore, an inner layer having a lower butylene / ethylene ratio compared to the middle layer is also provided.

[0036] According to one embodiment of the present invention, S / EB A >1.2S / EB M , preferably S / EB A >1.5S / EB M , and / or S / EB I >1.2S / EB M , preferably S / EB I >1.5S / EB M , and / or S / EB I =S / EB A Preferably, S / EB A <2.0S / EB M and / or S / EB I <2.0S / EBM is.

[0037] The SEBS used in the intermediate layer is preferably softer than the SEBS used in the inner and / or outer layer, in particular the SEBS of the intermediate layer or layers has a Shore hardness A (measured according to DIN EN ISO 868 (version 2003-10) and DIN ISO 7619-1 (version 2012-02)) of less than 50, preferably less than 45 and / or more than 30.

[0038] The SEBS used in the inner and / or outer layers may have a Shore A hardness of greater than 55, preferably greater than 62 and / or less than 80.

[0039] Intermediate layer ratio S / EB M is in one embodiment of the present invention less than 0.16, preferably less than 0.14 and / or greater than 0.10, preferably greater than 0.13. For example, an SEBS polymer having such properties is available under the trade designation Asahi Tuftec™ H1221.

[0040] S / EB ratio of inner layer and / or S / EB of outer layer A The ratio is, in one embodiment of the invention, greater than 0.18, preferably greater than 0.20, and / or less than 0.28, preferably less than 0.24. For example, an SEBS polymer having such properties is available under the trade designation Asahi Tuftec™ H1062.

[0041] In a further development of the invention, the phase polymer of the matrix phase polymer system of the intermediate layer also comprises a styrene-isoprene-styrene block copolymer (SIS).

[0042] In particular, styrene-ethylene / butylene-styrene block copolymer (SEBS) is present in a weight percentage of G MP1 and a weight percentage of styrene-isoprene-styrene block copolymer (SIS) is G MP2 Available in G MP1 >3G MP2 and / or GMP1 <5G MP2 is.

[0043] The matrix polymer of the intermediate layer, according to a further embodiment of the invention, is a polypropylene random copolymer, which combines well with the SEBS used, which has a high butylene / ethylene ratio, contributing to a soft intermediate layer.

[0044] According to one embodiment, the matrix polymer is in the intermediate layer a G MP or G of the phase polymer MP1+2 Weight proportion G substantially corresponding to the weight proportion of MM In particular, G MM =0.9~1.1 * G MP1+2 or G MM =0.9~1.1 * G MP G MP is especially G MP1 and G MP2 It is the harmony of.

[0045] The matrix polymer of the outer layer is, according to one embodiment of the invention, a polypropylene homopolymer rather than a PP random copolymer, thus achieving a fixed outer layer of the layer packet.

[0046] The softening temperature (Vicat softening temperature A / 50 / N) of the polypropylene used in the outer layer is preferably higher than that of the polypropylene used in the intermediate and / or inner layer, in particular the polypropylene of the outer layer has a softening temperature that is at least 10°C, preferably at least 15°C, higher than that of the polypropylene of the intermediate layer.

[0047] The Vicat softening temperature A / 50 / N of the PP of the outer layer is preferably above 140° C., particularly preferably above 150° C. and / or below 170° C. (measured in accordance with DIN EN ISO 306 (version 2014-03)).

[0048] The films according to the invention exhibit good weldability and good resistance in the case of heat sterilization, especially in the case of autoclaving.

[0049] The PP polymer used for the outer layer is preferably harder than the PP polymer used for at least the intermediate layer. According to one embodiment of the invention, the PP polymer used for the outer layer has a ball impression hardness H358 / 30 (according to DIN 53 505 (version 2000-08) / ISO 2039 (version 2003-06)) of more than 55 MPa, preferably more than 60 MPa and / or less than 80 MPa. The PP used for the intermediate and / or inner layer may have a ball impression hardness H358 / 30 of less than 60 MPa, preferably less than 50 and / or more than 35 MPa.

[0050] In the outer layer, the matrix polymer preferably has a weight percentage G AM and the phase polymer has a weight fraction G AP G AM >4G AP is.

[0051] According to one embodiment of the present invention, in the inner layer, the matrix polymer has a weight percentage G IM and the phase polymer has a weight fraction G IP G IM >3G IP In particular, in the inner layer, the weight ratio G of the matrix polymer IM is in the range of 70 wt% to 90 wt%, and the weight fraction G of the phase polymer IP is in the range of 10% by weight to 30% by weight.

[0052] The matrix polymer of the inner layer is also preferably a polypropylene random copolymer.

[0053] In the outer layer, the matrix polymer is present in a weight percentage G AM and the phase polymer has a weight fraction G AP and preferably G AM >4G AP is.

[0054] In the outer layer, the weight fraction of the matrix polymer G AM is preferably in the range of 75% by weight to 95% by weight, and the weight proportion G of the phase polymer AP is in the range of 5% by weight to 25% by weight.

[0055] Weight fraction G of the phase polymer in the intermediate layer MP1+2 is the weight fraction of the outer layer phase polymer G AP Higher than G MP1+2 >3G AP and / or G MP1+2 <5G AP It is preferable that:

[0056] In the middle layer, the weight fraction of the matrix polymer G MM is preferably in the range of 40% by weight to 60% by weight, and / or the weight fraction G of the phase polymer MP or weight ratio G of phase polymer MP1+2 In one embodiment, G is in the range of 40% to 60% by weight. MP is preferably at least G MP1 and G MP2 It consists of:

[0057] In particular, in the intermediate layer, the weight proportion G of styrene-ethylene / butylene-styrene block copolymer (SEBS) as the phase polymer MP1 is in the range of 30% by weight to 55% by weight, and / or the weight proportion G of styrene-isoprene-styrene block copolymer (SIS) as a further phase polymer MP2 is in the range of 0% by weight to 20% by weight.

[0058] According to one embodiment of the invention, the inner layer has a thickness D I and the intermediate layer has a thickness D M and the outer layer has a thickness D A It has 4D I <D M <5D A and / or 4D A <D M <5DI is.

[0059] The multilayer films used for packaging preferably have a total thickness of more than 150 μm, particularly preferably more than 180 μm and / or less than 250 μm, particularly preferably less than 220 μm.

[0060] The inner and / or outer layer of the multilayer film preferably has a thickness of more than 15 μm, particularly preferably more than 25 μm and / or less than 45 μm, particularly preferably less than 35 μm.

[0061] The intermediate layer preferably has a thickness of more than 100 μm, particularly preferably more than 120 μm and / or less than 170 μm, particularly preferably less than 150 μm, in particular from 125 μm to 145 μm.

[0062] According to the invention, the medical package is designed as an infusion bag filled with a medicinal liquid. The medicinal liquid is a liquid used for medical purposes, here preferably administered intravenously. Therefore, in a preferred embodiment, the medicinal liquid is an infusion liquid. Possible examples of such infusion liquids include: Sterile water; Physiological saline solutions, especially those containing NaCl, KCl, CaCl and / or Mg; sugar-containing solutions, especially glucose solutions; Solutions, emulsions and / or suspensions containing nutrients, in particular lipids, amino acids and / or glucose, for parenteral nutrition; Colloidal solutions, in particular colloidal solutions for blood replacement therapy (e.g. Voluven™); and / or So-called premix systems in which the active ingredient, e.g. paracetamol, is already added to the medicinal solution.

[0063] A medical package designed as an infusion bag filled with a medical solution may also be designated as a medicine.

[0064] Medical packages designed as infusion bags preferably have a storage capacity of 50 ml to 1000 ml.

[0065] If the infusion bag is designed as, for example, a multi-chamber bag, the infusion bag can have a total storage capacity of up to 3000 ml. Thus, according to one exemplary embodiment, the infusion bag can be configured as a three-chamber bag for parenteral nutrition. In each case, each chamber contains a component (lipid, amino acid, or glucose). The three chambers must first be separated from one another, for example, by inner tearable seams. Before applying the nutritional composition, these inner separating seams must be torn and the components must be mixed together.

[0066] The medical package designed as an infusion bag referred to above in this specification is characterized in that it is made of a film with multiple layers welded together, has at least one welded seam, and is filled with a medicinal solution, and the features described in the claims are also characterized in the weldable film described below and / or the welding method described below.

[0067] The present invention can also be illustrated by a weldable film, in particular the weldable film described above for medical packaging designed as an infusion bag, which is a multilayer film having at least one inner layer made of a matrix phase polymer system, a middle layer made of a matrix phase polymer system, and an outer layer made of a matrix phase polymer system, The matrix polymer of the matrix phase polymer systems of the inner layer, the intermediate layer, and the outer layer each comprises a polypropylene polymer (PP); the phase polymer of the matrix phase polymer system of the inner layer, the intermediate layer, and the outer layer each comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS); The styrene-ethylene / butylene-styrene block copolymer (SEBS) in the middle layer has a styrene-ethylene / butylene ratio of S / EB Mand the styrene-ethylene / butylene-styrene block copolymer (SEBS) of the outer layer has a styrene-ethylene / butylene ratio S / EB A and S / EB A >S / EB M It is characterized in that:

[0068] The film is processed using a welding method, for example an impulse welding method, to produce a medical package designed as an infusion bag and made of a multilayer film, 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; The matrix polymer of the matrix phase polymer systems of the inner layer, the intermediate layer, and the outer layer each comprises a polypropylene polymer (PP); the phase polymer of the matrix phase polymer system of the inner layer, the intermediate layer, and the outer layer each comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS); The styrene-ethylene / butylene-styrene block copolymer (SEBS) in the middle layer has a styrene-ethylene / butylene ratio of S / EB M and the styrene-ethylene / butylene-styrene block copolymer (SEBS) of the outer layer has a styrene-ethylene / butylene ratio S / EB A and S / EB A >S / EB M It is characterized in that:

[0069] The present invention provides an improved package made of a multilayer PP film that has high extensibility in the area of the welded seam, and does not tear the welded seam or cause ruptures in the area of the welded seam.

[0070] The proportion of PP in the multilayer film is preferably more than 55% by weight, particularly preferably more than 60% by weight and / or less than 70% by weight, particularly preferably less than 65% by weight.

[0071] The subject matter of the invention will be explained in more detail below with reference to an exemplary embodiment that is diagrammatically represented on the basis of FIGS. [Brief explanation of the drawings]

[0072] [Figure 1] FIG. 1 shows a medical package designed as an infusion bag. [Figure 2] FIG. 1 is a schematic cross-sectional view of a multilayer PP film used in an infusion bag. DETAILED DESCRIPTION OF THE INVENTION

[0073] FIG. 1 shows a medical package designed as an infusion bag 1 .

[0074] The infusion bag 1 consists of two multilayer films 8 welded together. The multilayer films 8 are joined together via a longitudinal weld seam 7 and a transverse weld seam 6 to form the bag, which is filled with a medicinal solution. The bag 1 here is a single-chamber bag.

[0075] The multilayer films 8 are joined together, for example, by impulse welding. In this case, the films 8 are welded by a welding tool with heatable sealing strips that contact the films by temporarily heating the sealing strips so that the films clamped between the sealing strips are melted and welded at least in sections. The impulse welding method is described, for example, in the published patent application EP 0 911 141 (Fresenius Medical Care Deutschland GmbH).

[0076] The infusion bag 1 has at least one port, and in this exemplary embodiment, of the two ports 2a, 3a, one port 2a serves to fill with liquid, for example to administer medicine, and the other port 3a serves to deliver the medicinal liquid.

[0077] The ports 2 a, 3 a are in this exemplary embodiment equipped with a weld-in shuttle, by means of which the ports 2 a, 3 a are welded to the region 5 of the transverse weld seam 6 .

[0078] Here, two ports 2a and 3a constitute the lower parts of connectors 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 arranged on the lower parts 2a and 3a, in particular by snap-on. A sealing element (not shown in the figures) that welds the ports 2a and 3a or the passages of connectors 2 and 3 to the bag volume is preferably enclosed in a positive locking manner between the respective lower parts 2a and 3a and upper parts 2b and 3b. The above-mentioned sealing elements are self-closing, resealable elastomeric elements that can be pierced with a spike and / or even a needle to extract or dispense liquid. After the spike and / or needle is removed, the sealing elements close automatically. For example, polyisoprene can be used as the elastomeric material. The upper parts 2b and 3b of connectors 2 and 3 also in each case comprise a cover, preferably a breakable cap 2c and 3c, that covers the sealing element. The respective sealing element is therefore only accessible after removing or cutting off the cap 2c, 3c.

[0079] The infusion bag 1 also has a hanger 4 opposite the at least one port 2a, 3a for attaching the infusion bag to an IV stand or rack. The hanger 4 can be designed as a recess or a punched slot in the transverse welded seam 6.

[0080] FIG. 2 is a schematic diagram of the multilayer film 8 used in the infusion bag 1.

[0081] The film 8 consists of an inner layer 9c, which comes into contact with the chemical solution, a middle layer 9b, and an outer layer 9a. When the film 8 is welded, the layers 9a, 9b, and 9c melt. In this case, all material in the area of the weld seam transitions to a molten state during impulse welding.

[0082] The inner layer 9c and the outer layer 9a each have a thickness of 25 μm to 45 μm, and the intermediate layer 9b has a thickness of 125 μm to 145 μm.

[0083] The outer layer 9a is made of a PP homopolymer to which SEBS has been added to improve the mechanical properties. AM The weight percentage of SEBS G is in the range of 82% by weight to 88% by weight. AP is in the range of 12% to 18% by weight.

[0084] The inner layer 9c is made of a PP random copolymer to which SEBS has been added to improve mechanical properties. IM The weight percentage of SEBS G is in the range of 77% by weight to 83% by weight. IP is in the range of 17% to 23% by weight.

[0085] The intermediate layer 9b is at least softer than the outer layer 9a. It is also preferably softer than the inner layer 9c. The intermediate 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 weight proportion G of the PP random copolymer MM The weight percentage of SEBS G is in the range of 47% by weight to 53% by weight. MP1 The weight proportion G of the second thermoplastic elastomer SIS is in the range of 37% by weight to 43% by weight. MP2 is in the range of 7% by weight to 13% by weight. The weight proportion of the thermoplastic elastomer (ie, SEBS and optionally SIS) is higher in the intermediate layer 9b than in the inner layer 9c and the outer layer 9a.

[0086] The SEBS in the intermediate layer 9b also has a higher ethylene / butylene weight percentage than the SEBS in the inner layer 9c and the outer layer 9a. M The ratio is 12 / 88. S / EB in the outer layer 9a and / or the inner layer 9c A The ratio, in contrast, is 18 / 82.

[0087] In this way, the soft middle layer 9b has a finer distribution of SEBS than the inner layer 9c and the outer layer 9a, which significantly improves the mechanical properties of the infusion bag, especially in the case of drop tests. These improved mechanical properties are evident both at room temperature and at temperatures as low as 4°C.

[0088] The film 8 is produced by coextrusion of the individual layers 9a-9c.

[0089] The mechanical properties of the infusion bag 1 can be easily improved by the present invention, especially in the area of the welded seams 6, 7 and over a wide temperature range. [Explanation of symbols]

[0090] 1 infusion bag 2 Connectors for supplying additives or drugs 2a Bottom of connector or port 2b Top of connector 2c Upper cut 3 Connector for discharging chemicals 3a Bottom of connector or port 3b Top of connector 3c Upper cut 4 hangers 5 Welding shuttle area 6 Horizontal welded seams 7. Vertical welded seams 8 Film 9a outer layer 9b Middle layer 9c Inner layer

Claims

1. A medical package designed as an infusion bag (1), made of a film (8) with several layers welded together, having at least one welded seam (6, 7), and filled with a medicinal solution; The multilayer film (8) has at least one 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, a matrix polymer of the matrix phase polymer system of each of the inner layer, the intermediate layer, and the outer layer includes a polypropylene polymer (PP); a matrix phase polymer of each of the inner layer, the intermediate layer, and the outer layer comprises a styrene-ethylene / butylene-styrene block copolymer (SEBS); the outer layer (9a) is made of a PP homopolymer to which SEBS has been added, the weight proportion G AM of the PP homopolymer being in the range of 82% to 88% by weight, and the weight proportion G AP of the SEBS being in the range of 12% to 18% by weight; the intermediate layer (9b) is made of a PP random copolymer plus SEBS and styrene-isoprene-styrene block copolymer (SIS), the weight percentage G MM of the PP random copolymer is in the range of 47% to 53% by weight, the weight percentage G MP1 of the SEBS is in the range of 37% to 43% by weight, and the weight percentage G MP2 of the SIS is in the range of 7% to 13% by weight; the inner layer (9c) is made of the PP random copolymer to which the SEBS has been added, the weight percentage G IM of the PP random copolymer being in the range of 77% to 83% by weight, and the weight percentage G IP of the SEBS being in the range of 17% to 23% by weight; The styrene-ethylene / butylene-styrene block copolymer (SEBS) of the intermediate layer (9b) has a styrene-ethylene / butylene ratio S / EB Ｍ The styrene-ethylene / butylene-styrene block copolymer (SEBS) of the outer layer (9a) has a styrene-ethylene / butylene ratio S / EB Ａ and S / EB Ａ >S / EB Ｍ This is a medical package designed as an infusion bag.

2. The styrene-ethylene / butylene-styrene block copolymer of the inner layer (9c) has a styrene-ethylene / butylene ratio S / EB Ｉ and S / EB Ｉ >S / EB Ｍ 2. A medical package designed as an infusion bag (1) according to claim 1, characterized in that:

3. S / EB Ａ >1.2S / EB Ｍ , preferably S / EB Ａ >1.5S / EB Ｍ , and / or S / EB Ｉ >1.2S / EB Ｍ , preferably S / EB Ｉ >1.5S / EB Ｍ , and / or S / EB Ｉ = S / EB Ａ A medical package designed as an infusion bag (1) according to claim 1 or 2, characterized in that

4. The S / EB M in the intermediate layer (9b) is 12 / 88, and A medical package designed as an infusion bag (1) according to any one of claims 1 to 3, characterized in that the S / EB A in the outer layer (9a) and / or the inner layer (9c) is 18 / 82.

5. In the intermediate layer (9b), the styrene-ethylene / butylene-styrene block copolymer (SEBS) is contained in a weight ratio of G ＭＰ１ wherein the styrene-isoprene-styrene block copolymer (SIS) is in a weight percentage of G ＭＰ２ It is provided by G ＭＰ１ >3G ＭＰ２ and / or G ＭＰ１ <5G ＭＰ２ A medical package designed as an infusion bag (1) according to any one of claims 1 to 4, characterized in that

6. In the intermediate layer (9b), the matrix polymer has a weight ratio G ＭＰ Weight proportion G substantially corresponding to ＭＭ and G ＭＭ =0.9~1.1*G ＭＰ A medical package designed as an infusion bag (1) according to any one of claims 1 to 5, characterized in that

7. In the inner layer (9c), the matrix polymer has a weight ratio of G ＩＭ and the phase polymer has a weight percentage G ＩＰ and G ＩＭ >3G ＩＰ A medical package designed as an infusion bag (1) according to any one of claims 1 to 6, characterized in that

8. In the outer layer (9a), the matrix polymer has a weight ratio of G ＡＭ and the phase polymer has a weight percentage G ＡＰ and G ＡＭ >4G ＡＰ A medical package designed as an infusion bag (1) according to any one of claims 1 to 7, characterized in that

9. The weight ratio G of the phase polymer in the intermediate layer (9b) ＭＰ１＋２ is the weight ratio G of the phase polymer in the outer layer (9a). ＡＰ Higher than G ＭＰ１＋２ >3G ＡＰ and / or G ＭＰ１＋２ <5G ＡＰ A medical package designed as an infusion bag (1) according to any one of claims 1 to 8, characterized in that

10. The inner layer (9c) has a thickness D Ｉ and the intermediate layer (9b) has a thickness D Ｍ and the outer layer (9a) has a thickness D Ａ and 4D Ｉ <D Ｍ <5D Ａ and 4D Ａ <D Ｍ <5D Ｉ A medical package designed as an infusion bag (1) according to any one of claims 1 to 9, characterized in that

11. A medical package designed as an infusion bag (1) described in any one of claims 1 to 10, wherein the thickness of each of the inner layer (9c) and the outer layer (9a) is 25 to 45 μm, and the thickness of the intermediate layer (9b) is 125 to 145 μm.

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