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EP-4590246-B1 - MULTI-LAYER FILM FOR OSTOMY APPLIANCES

EP4590246B1EP 4590246 B1EP4590246 B1EP 4590246B1EP-4590246-B1

Inventors

  • ZHOU, Sean, Xixian

Dates

Publication Date
20260513
Application Date
20230914

Claims (15)

  1. A multilayer film (10) for an ostomy appliance, comprising: a barrier layer (12), the barrier layer being substantially impermeable to malodor causing compounds; wherein the barrier layer (12) is arranged between a first and a second outer layer (22, 24), and characterised in that the first and second outer layers are formed from a polymeric mixture: - comprising about 90 wt.% to about 99 wt.% of a polar polymer and about 1 wt.% to about 10 wt.% of a slip agent and/or an anti-block agent, - the polymeric mixture being free of a non-polar polymer, and- the polar polymer being selected from ethylene vinyl acetate (EVA) copolymer, ethylene methyl acrylate copolymer, ethylene acrylic acid copolymer, ethylene methyl acrylic acid copolymer, and polylactic acid homopolymer.
  2. The multilayer film (10) of claim 1, wherein the multilayer film has a kinetic coefficient of friction of about 0.05 to about 0.30 when measured according to ASTM D1894 as valid at the priority date of the present disclosure, 22 September 2022.
  3. The multilayer film (10) of any of claims 1-2, wherein the multilayer film has a blocking force below about 100g/100cm 2 when measured according to ASTM D3354 as valid at the priority date of the present disclosure, 22 September 2022.
  4. The multilayer film (10) of claim 1, wherein the multilayer film has a kinetic coefficient of friction of about 0.06 to about 0.20 when measured according to ASTM D1894, as valid at the priority date of the present disclosure, 22 September 2022, and a blocking force below about 70g/100cm 2 when measured according to ASTM D3354 as also valid at the priority date of the present disclosure.
  5. The multilayer film (10) of any of claims 1-4, wherein each of the first and second outer layers (22, 24) is formed from a polymeric mixture comprising about 92 wt.% to about 97 wt.% of a polar polymer and about 3 wt.% to about 8 wt.% of a slip agent and/or an anti-block agent.
  6. The multilayer film (10) of any of claims 1-3. wherein each of the first and second outer layers (22, 24) is formed from a polymeric mixture comprising about 93 wt.% to about 96 wt.% of a polar polymer and about 4 wt.% to about 7 wt.% of a slip agent and/or an anti-block agent.
  7. The multilayer film (10) of any of claims 1-6, wherein the slip agent is selected from the group consisting of oleamide, erucamide, stearamide, behenamide. oley/palmitamide, stearyl erucamide, ethylene bis-steramide, ethylene bis-oleamide, and the blends thereof.
  8. The multilayer film (10) of any of claims 1-7, wherein the anti-block agent is selected from the group consisting of silica, talc, kaolin, mica, calcium carbonate, paraffinic waxes, ethylene and propylene oxide, fatty 7 acid soaps, fatty 7 acid amides, silicones.
  9. The multilayer film (10) of claim 1, wherein each of the first and second outer layers (22, 24) is formed from a polymeric mixture comprising about 93 wt.% to about 95 wt.% of an EVA copolymer, about 3 wt.% to about 5 wt.% of a slip agent, and about 1 wt.% to about 3 wt.% of an anti-block agent, wherein the multilayer film has a kinetic coefficient of friction of about 0.06 to about 0.20 when measured according to ASTM D1894, as valid at the priority date of the present disclosure, 22 September 2022, and a blocking force below- about 70g/100cm 2 when measured according to ASTM D3354 as also valid at the priority date of the present disclosure.
  10. The multilayer film (10) of claim 1, wherein each of the first and second outer layers (22, 24) is formed from a polymeric mixture comprising about 94 wt.% of an EVA copolymer, about 4 wt.% of a slip agent, and about 2 wt.% of an anti -block agent, wherein the multilayer film has a kinetic coefficient of friction of about 0.06 to about 0.20 when measured according to ASTM D1894, as valid at the priority date of the present disclosure, 22 September 2022, and a blocking force below about 70g/100cm 2 when measured according to ASTM D3354, as also valid at the priority date of the present disclosure.
  11. The multilayer film (10) of any of claims 1-10, wherein the barrier layer is formed from a mixture comprising about 65 wt.% to about 100 wt.% of an amorphous polyamide and about 0 wt.% to about 35 wt.% of a maleic anhydride modified olefin or an epoxy modified olefin.
  12. The multilayer film (10) of any of claims 1-11, wherein the multilayer film has, in order, an outer layer (22), an inner layer (18), a tie layer (14), a barrier layer (12), a tie layer (16), an inner layer (20), and an outer layer (24) construction.
  13. The multilayer film (10) of claim 12, wherein the tie layers are formed from a maleic anhydride grafted resin, wherein the resin is one or more of an ethylene based copolymer, a propylene-based copolymer, an ethylene-octene polymer and a styrene block copolymer, and wherein the inner layers are formed from an ethylene propylene copolymer (polypropylene elastomer) based resin, an ethylene-octene based resin or blends thereof.
  14. The multilayer film (10) of any of claims 12-13, wherein the multilayer film has an Elmendorf tear strength in machine direction measured by ASTM D19222-09, as valid at the priority date of the present disclosure, 22 September 2022, of at least about 200g/0.0254mm (200g/mil).
  15. An ostomy pouch (100, 200, 300, 400) formed of the multilayer film (10) of any of claims 1-14, comprising: two side walls, wherein each of the side walls is formed of the multilayer film (10) of any of claims 1-14; a stoma-receiving opening (112) on one of the side walls; and wherein the two side walls are heat sealed together along peripheral edges of the side walls.

Description

BACKGROUND The present disclosure relates to a multilayer film material, and more particularly to multi-layer films for ostomy appliances. Ostomy products and other applications relating to the storage of bodily liquids are highly demanding and typically subject materials used in such products to high levels of moisture. At the same time, it is extremely important that the odor barrier properties of the material are and remain high throughout their useful life. In addition, it is imperative that the mechanical strength of the material is also high and remains high for a sufficiently long period of time for extended use of the product. Other factors and properties that must also be considered in ostomy product use are the comfort of the material, as such products are worn next to the user's body, the flexibility of the material so that it conforms to the user's movements, and the quietness of the product so that wearing such a product is as audibly imperceptible as possible. One film used in the manufacture of ostomy pouches, disclosed in International application publication WO93/11938, is a five-layer barrier structure having a gas barrier layer, two moisture barrier layers and optionally one or more adhesive layers disposed therebetween. The moisture barrier layer is a mesophase PP-based material which contacts one or both of the sides of the gas barrier layer. The gas barrier layer is made of an EVOH copolymer. Other multi-layer films, such as those disclosed in U.S. Patent Nos. 4,239,826 and 4,254,169, which include an oxygen barrier layer formed of vinyl alcohol polymer or copolymers (e.g. PVOH, EVOH), and moisture barrier layers formed of partially hydrolyzed vinyl acetate polymer or copolymer, or modified polyolefins, are also known. Such films have been found to be useful in the manufacture of food packaging containers. A five layer chlorine-free ostomy pouch film is also known. Such a film, which is disclosed in Giori, U.S. Patent No. 7,270,860, has a core odor barrier layer formed of a blend or a compound including amorphous polyamide, and anhydride-modified olefin polymer or copolymer. The film also includes two tie layers on both sides of the core layer and two EVA or EVA-based surface layers. Still another multilayer film for an ostomy bag is disclosed in Chang et al., U.S. Patent No. 9,301,869. Chang et al. discloses a multilayer film including a barrier layer formed from amorphous polyamide resin and a maleic anhydride modified olefin or an epoxy modified olefin, tie layers formed from maleic anhydride (MAH) grafted blend of ethylene propylene rubber (EPR) and polypropylene (PP), inner layers formed from one of an ethylene propylene copolymer based resin, an ethylene-octene based resin and blends-thereof, and outer layers formed from a blend of ethylene vinyl acetate and polypropylene-based resin. JP2015502984A discloses polymeric films that include at least one odor absorbing layer. Specifically, the odor absorbing layer may include a polyvinylidene chloride polymer and magnesium oxide, a magnesium salt, magnesium hydroxide, a zeolite, or a combination thereof. The use of the disclosed films in ostomy pouches and other medical products is also described. Present disclosure provides a multilayer film having improved sealing properties when compared to multilayer films including outer layers that contain a non-polar polymer, while maintaining other film properties necessary for ostomy appliances. BRIEF SUMMARY The present disclosure provides a multilayer film as detailed in claim 1, and an ostomy pouch as detailed in claim 15. Advantageous features are provided in dependent claims. In the following, it is understood that 1 inch corresponds to 2.54 cm, 1 psi corresponds to 0.06895 bar, and 365 °F corresponds to 185 °C. In one aspect, a multilayer film for an ostomy pouch includes a barrier layer arranged between first and second outer layers. The barrier layer is substantially impermeable to malodor causing compounds. Each of the first and second outer layers is formed from a polymeric mixture comprising about 90 wt.% to about 99 wt.% of a polar polymer, such as acidic copolymer, ester copolymer, maleic anhydride modified polyolefin, and blends thereof, and about 1 wt.% to about 10 wt.% of a slip agent and/or an anti-block agent, wherein the polar polymer is selected from the group consisting of ethylene vinyl acetate (EVA) copolymer, ethylene methyl acrylate copolymer, ethylene acrylic acid copolymer, ethylene methyl acrylic acid copolymer, and polylactic acid homopolymer, and wherein the polymeric mixture may be free of a non-polar polymer. In an embodiment, the multilayer film may be configured to have a kinetic coefficient of friction of about 0.05 to about 0.30 when measured according to ASTM D1894. For example, the multilayer film may be configured to have a kinetic coefficient of friction of about 0.06 to about 0.28 or 0.08 to about 0.25. In an embodiment, the multilayer film may be conf