Search

US-20260124111-A1 - INFUSION BAG

US20260124111A1US 20260124111 A1US20260124111 A1US 20260124111A1US-20260124111-A1

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.

Inventors

  • Torsten Brandenburger
  • BEATRIX HEUEL-HOEMMEN

Assignees

  • FRESENIUS KABI DEUTSCHLAND GMBH

Dates

Publication Date
20260507
Application Date
20250818
Priority Date
20180821

Claims (20)

  1. 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 MP1 and a styrene-isoprene-styrene block copolymer (SIS) with a proportion by weight G MP2 in which G MP1 is greater than 3*G 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. 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. 3 . The film of claim 1 , wherein G MP1 is less than 5*G MP2 .
  4. 4 . The film of claim 1 , wherein G MP1 is in the range of 30-55% and G MP2 is in the range of 7-13%.
  5. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 15 . The film of claim 11 , wherein the phase polymer of the intermediate layer further comprises a styrene-isoprene-styrene block copolymer (SIS).
  16. 16 . The film of claim 15 , wherein the SEBS of the intermediate layer has a proportion by weight G MP1 and the SIS has a proportion by weight G MP2 in which G MP1 is greater than 3*G MP2 and is less than 5*G MP2 .
  17. 17 . The film of claim 16 , wherein G MP1 is in the range of 30-55% and G MP2 is in the range of 7-13%.
  18. 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. 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. 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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 18/734,051, filed Jun. 5, 2024, and issued as U.S. Pat. No. 12,390,397 on Aug. 19, 2025, which is a continuation of U.S. patent application Ser. No. 17/253,424, filed Dec. 17, 2020, and issued as U.S. Pat. No. 12,005,026 on Jun. 11, 2024, which is a U.S. National Phase of International Application No. PCT/EP 2019/072263, filed Aug. 20, 2019, which claims the benefit of the European Patent Application No. 18189930.3, filed Aug. 21, 2018, the contents of which are hereby incorporated by reference in their entirety. FIELD OF THE INVENTION The invention relates to a medical package designed as an infusion bag, which medical package is made from films comprising multiple layers welded to one another and which is filled with a medical liquid for infusion or for parenteral nutrition. BACKGROUND OF THE INVENTION Infusion bags, which consist of films comprising multiple layers welded to one another, are known. They consist of films that are welded directly to one another and comprise at least one withdrawal port. The requirements for infusion bags are high. Thus, infusion bags must withstand mechanical loads to a significant extent. At the same time, the films used for this purpose must be free of contaminants. In general, there is also the requirement to be able to subject the infusion bag to thermal sterilization, typically at a temperature of 121° C. Amongst others, PVC films are used. Multi-layer films of PP (polypropylene) are, however, particularly suitable. The tear resistance can in particular be increased through different layers of PP, i.e. by providing a multi-layer PP film. Infusion bags made of multi-layer, flexible films have a high mechanical stability in regard to the tearing of a film, since the film can yield in the case of mechanical loads. In the case of flexible films, it is, in turn however, more difficult to ensure high mechanical stability in the region of the weld seams. It is also known that the mechanical properties of PP films can be improved by providing a matrix-phase polymer system, In this case, a thermoplastic elastomer can be distributed e.g. in a PP matrix. This increases the impact strength of the material and thus improves the tear resistance of a multi-layer composite. For example, the patent document U.S. Pat. No. 5,783,269 A (Fresenius AG) presents a multi-layer PP film. The layers of this film can comprise a styrene-ethylene/butylene-styrene block copolymer (SEBS) or a styrene-isoprene-styrene block copolymer (SIS). In this way, the stability in the case of impact and tensile loads can be improved. Multi-layer PP films with SEBS are also described in the two patent applications WO 2011/128185 A1 and KR 2003 046120 A. OBJECT OF THE INVENTION The object underlying the invention is to improve the mechanical properties of a medical package designed as an infusion bag based on polypropylene. It is in particular an object of the invention to provide an infusion bag made of a multi-layer PP film, in which the film has a high flexibility in the region of the weld seams, without the weld seam being tom. SUMMARY OF THE INVENTION The object of the invention is already achieved by a medical package designed as an infusion bag according to claim 1. Preferred embodiments of the invention can be inferred from the subject matter of the dependent claims, the description and the drawings. The invention will be described generally by a medical package designed as an infusion bag, which is made up of a film comprising multiple layers welded to one another and has at least one weld seam, preferably longitudinal and transverse weld seams, and is filled with a medical liquid, with the multi-layer film having 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, with the matrix polymer of the matrix-phase polymer system of the inner layer, the intermediate layer and the outer layer each comprising a polypropylene polymer (PP) andthe phase polymer of the matrix-phase polymer system of the inner layer, the intermediate layer and the outer layer each comprising a styrene-ethylene/butylene-styrene block copolymer (SEBS),and with the styrene-ethylene/butylene-styrene block copolymer (SEBS) of the intermediate layer having a styrene-ethylene/butylene ratio (S/EBM) and the styrene-ethylene/butylene-styrene block copolymer (SEBS) of the outer layer having a styrene-ethylene/butylene ratio (S/EBA), in which in particular S/EBAA>S/EBM. According to claim 1, the invention will be described by a medical package designed as an infusion bag, which is made up of a film comprising multiple layers welded to one another and has at least one weld seam and is filled with a medical liquid, with the multi-layer film having at least one inner layer of a matrix-phase polymer system, an intermediate lay