INFUSION BAG

Abstract

A medical package is made from a multi-layer film and is filled with a medical liquid for infusion and/or for parenteral nutrition. The medical package has at least one weld seam and 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.

Claims

1. A film comprising: an inner layer; an outer layer; and an intermediate layer disposed between the inner layer and the outer layer, wherein (i) the outer layer comprises a matrix-phase polymer with a phase polymer having a styrene-ethylene/butylene-styrene block copolymer (SEBS), (ii) the intermediate layer comprises a matrix-phase polymer with a phase polymer comprising a SEBS with a proportion by weight G.sub.MP1 and a styrene-isoprene-styrene block copolymer (SIS) with a proportion by weight G.sub.MP2 in which G.sub.MP1 is greater than 3*G.sub.MP2, and (iii) a ratio of styrene to ethylene and butylene of the SEBS of the outer layer is greater than a ratio of styrene to ethylene and butylene of the SEBS of the intermediate layer.

2. The film of claim 1, wherein the ratio of styrene to ethylene and butylene of the SEBS of the outer layer is greater than 1.2 times the ratio of styrene to ethylene and butylene of the SEBS of the intermediate layer.

3. The film of claim 1, wherein G.sub.MP1 is less than 5*G.sub.MP2.

4. The film of claim 1, wherein G.sub.MP1 is in the range of 30-55% and G.sub.MP2 is in the range of 7-13%.

5. The film of claim 1, wherein the matrix-phase polymer of the outer layer and the intermediate layer is a polypropylene polymer, and wherein the polypropylene polymer of the outer layer is harder than the polypropylene polymer of the intermediate layer.

6. The film of claim 5, wherein the polypropylene polymer of the outer layer has a ball impression hardness (H 358/30) of above 55 MPa and below 80 MPa, and the polypropylene polymer of the intermediate layer has a ball impression hardness H 358/30 of above 35 MPa and below 60 MPa.

7. The film of claim 1, wherein the inner layer comprises a matrix-phase polymer with a phase polymer comprising a SEBS, wherein a ratio of styrene to ethylene and butylene of the SEBS of the inner layer is greater than the ratio of styrene to ethylene and butylene of the SEBS of the intermediate layer.

8. A medical package comprising the film of claim 1, wherein the medical package has at least one seam and is configured to be filled with a liquid.

9. A pharmaceutical product comprising an infusion bag comprising the film of claim 1 filled with a medical liquid, wherein the medical liquid comprises at least one of sterile water, a saline solution, a carbohydrate solution, a solution at least one of sterile water, a saline solution, a carbohydrate solution, a solution, emulsion and/or suspension with nutrients for parenteral nutrition, a colloid solution, or a premix comprising an active ingredient.

10. The pharmaceutical product of claim 9, wherein the infusion bag is a multi-chamber bag, wherein each chamber is separated from one another by an inner seam, and the medical liquid in each chamber comprises a solution, emulsion or suspension with nutrients for parenteral nutrition.

11. A film comprising: an inner layer; an outer layer; and an intermediate layer disposed between the inner layer and the outer layer, wherein (i) the outer layer comprises a matrix-phase polymer comprising a polypropylene polymer with a phase polymer having a styrene-ethylene/butylene-styrene block copolymer (SEBS), (ii) the intermediate layer comprises a matrix-phase polymer comprising a polypropylene polymer with a phase polymer comprising a SEBS, (iii) a ratio of styrene to ethylene and butylene of the SEBS of the outer layer is greater than a ratio of styrene to ethylene and butylene of the SEBS of the intermediate layer, and (iv) the polypropylene polymer of the outer layer is harder than the polypropylene polymer of the intermediate layer.

12. The film of claim 11, wherein the polypropylene polymer of the outer layer has a ball impression hardness (H 358/30) of above 55 MPa and below 80 MPa, and the polypropylene polymer of the intermediate layer has a ball impression hardness H 358/30 of above 35 MPa and below 60 MPa.

13. The film of claim 11, wherein the polypropylene polymer of the outer layer is a polypropylene homopolymer and the polypropylene polymer of the intermediate layer is a polypropylene random copolymer.

14. The film of claim 11, wherein the ratio of styrene to ethylene and butylene of the SEBS of the outer layer is greater than 1.2 times the ratio of styrene to ethylene and butylene of the SEBS of the intermediate layer.

15. The film of claim 11, wherein the phase polymer of the intermediate layer further comprises a styrene-isoprene-styrene block copolymer (SIS).

16. The film of claim 15, wherein the SEBS of the intermediate layer has a proportion by weight G.sub.MP1 and the SIS has a proportion by weight G.sub.MP2 in which G.sub.MP1 is greater than 3*G.sub.MP2 and is less than 5*G.sub.MP2.

17. The film of claim 16, wherein G.sub.MP1 is in the range of 30-55% and G.sub.MP2 is in the range of 7-13%.

18. The film of claim 11, wherein the inner layer comprises a matrix-phase polymer with a phase polymer comprising a SEBS, wherein a ratio styrene to ethylene and butylene of the SEBS of the inner layer is greater than the ratio of styrene to ethylene and butylene of the SEBS of the intermediate layer.

19. A medical package comprising the film of claim 11, wherein the medical package has at least one seam and is configured to be filled with a liquid.

20. A pharmaceutical product comprising an infusion bag comprising the film of claim 11 filled with a medical liquid, wherein the medical liquid comprises at least one of sterile water, a saline solution, a carbohydrate solution, a solution at least one of sterile water, a saline solution, a carbohydrate solution, a solution, emulsion and/or suspension with nutrients for parenteral nutrition, a colloid solution, or a premix comprising an active ingredient.

21. The pharmaceutical product of claim 20, wherein the infusion bag is a multi-chamber bag, wherein each chamber is separated from one another by an inner seam, and the medical liquid in each chamber comprises a solution, emulsion or suspension with nutrients for parenteral nutrition.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0095] The subject matter of the invention will be explained in more detail below with reference to a schematically represented exemplary embodiment on the basis of the drawings FIG. 1 to FIG. 2.

[0096] FIG. 1 shows a medical package designed as an infusion bag.

[0097] FIG. 2 is a schematic sectional view of the multi-layer PP film used for the infusion bag.

DETAILED DESCRIPTION OF THE DRAWINGS

[0098] FIG. 1 shows a medical package designed as an infusion bag 1.

[0099] The infusion bag 1 consists of two multi-layer films 8 welded to one another. The multi-layer films 8 are connected to one another via the longitudinal weld seams 7 and the transverse weld seams 6, such that a bag is formed, which is filled with a medical liquid. The bag 1 is here a single-chamber bag.

[0100] The multi-layer films 8 are for example connected to one another by means of an impulse welding method. In this case, the films 8 are welded by means of a welding tool with heatable sealing strips, which come into contact with the film, by the sealing strips being temporarily heated, such that the films clamped between the sealing strips are molten at least in sections and are thus welded. An impulse welding method is for example illustrated in the published patent application EP 0 911 141 A2 (Fresenius Medical Care Deutschland GmbH).

[0101] The infusion bag 1 comprises at least one port, in this exemplary embodiment two ports 2a, 3a, of which one port 2a serves to fill liquid, for example to dose a medicine, and another port 3a to withdraw the medical liquid.

[0102] The ports 2a, 3a comprise in this exemplary embodiment a weld-in shuttle, by means of which they are welded in a region 5 of a transverse weld seam 6.

[0103] The two ports 2a and 3a here each provide the lower part of a connector 2 and 3. The two connectors 2 and 3 are each formed by the two mentioned lower parts 2a and 3a and by the upper parts 2b and 3b. The upper part 2b, 3b, is preferably placed on the lower part 2a, 3a, in particular snapped-on. A sealing element (not represented here in the figures), which welds the passage in the port 2a, 3a or in the connector 2, 3 to the bag volume, is preferably enclosed in a positive-locking manner, between the respective lower part 2a, 3a and the upper part 2b, 3b. The mentioned sealing element is a self-closing, resealable elastomer element, which can be penetrated with a spike and/or even with a needle, in order to withdraw or supply liquid. After removing the spike and/or the needle, the sealing element closes automatically. Polyisoprene can e.g. be used as the elastomer material. The upper part 2b, 3b of the connector 2, 3 also in each case comprises a covering, preferably a breakable cap 2c, 3c which covers the sealing element. The respective sealing element is therefore accessible only after removing or breaking off the cap 2c, 3c.

[0104] The infusion bag 1 also comprises, on the side opposite at least one port 2a, 3a, a hanger 4 for attaching the infusion bag to an infusion stand or a rack. The hanger 4 can be designed as a indent or stamped-out slot in the transverse weld seam 6.

[0105] FIG. 2 is a schematic view of the multi-layer film 8 used for the infusion bag 1.

[0106] The film 8 consists of an inner layer 9c in contact with the medical liquid, an intermediate layer 9b and an outer layer 9a. When the films 8 are welded, the layers 9a, 9b, 9c become molten. In this case, all the material in the region of the weld seam passes to a molten state during the impulse welding.

[0107] The inner and the outer layer 9 c, 9 a are each 25-45 m thick. The intermediate layer 9 b has a thickness of 125-145 m.

[0108] The outer layer 9a consists of a PP homopolymer, to which is added SEBS to improve the mechanical properties. The proportion by weight G.sub.AM of the PP homopolymer is in a range of 82-88% by weight. The proportion by weight G.sub.AP of the SEBS is in a range of 12-18% by weight.

[0109] The inner layer 9c consists of a PP random copolymer, to which is added SEBS to improve the mechanical properties. The proportion by weight G.sub.IM of the PP random copolymer is in a range of 77-83% by weight. The proportion by weight G.sub.IP of the SEBS is in a range of 17-23% by weight.

[0110] The intermediate layer 9b is softer than at least the outer layer 9a. It is also preferably softer than the inner layer 9c. The intermediate layer 9b consists of a PP random copolymer which is softer compared to the PP of the outer layer 9a, to which SEBS and optionally SIS is added. The proportion by weight G.sub.MM of the PP random copolymer is in a range of 47-53% by weight. The proportion by weight G.sub.MP1 of the SEBS is in the range of 37-43% by weight. The proportion by weight G.sub.MP2 of the second thermoplastic elastomer SIS is in the range of 7-13% by weight. The proportion by weight of thermoplastic elastomers (i.e. SEBS and optionally SIS) is in the intermediate layer 9b higher than in the inner and outer layer 9a, 9c.

[0111] The SEBS of the intermediate layer 9b also has a higher proportion by weight of ethylene/butylene than the SEBS in the inner and outer layer 9a, 9c. The S/EB.sub.M ratio in the intermediate layer 9b is 12/88. The S/EB.sub.A ratio in the outer layer 9a and/or in the inner layer 9c is, in contrast, 18/82.

[0112] In this way, a soft intermediate later 9b is provided with SEBS more finely distributed compared to the inner and outer layer 9c, 9a which improves to a great extent the mechanical properties of the infusion bag, in particular in the case of fall tests. These improved mechanical properties appear both at room temperature and also at lower temperatures of down to 4 C.

[0113] The film 8 is produced by co-extrusion of the individual layers 9a-9c.

[0114] The mechanical properties of an infusion bag 1 can be easily improved by the invention in particular in the region of the weld seams 6, 7 and over a wide temperature range.

LIST OF REFERENCE NUMERALS

[0115] 1 Infusion bag [0116] 2 Connector for supplying an additive or medicine [0117] 28 Lower part or port of the connector [0118] 2b Upper part of the connector [0119] 2c Break-off part of the upper part [0120] 3 Connector for withdrawing a medical liquid [0121] 3a Lower part or port of the connector [0122] 3b Upper part of the connector [0123] 3c Break-off part of the upper part [0124] 4 Hanger [0125] 5 Region weld-in shuttle [0126] 6 Transverse weld seam [0127] 7 Longitudinal weld seam [0128] 8 Film [0129] 9a Outer layer [0130] 9b Intermediate layer [0131] 9c Inner layer