Multi-barrier layer film for ostomy appliance

Abstract

A multi-barrier layer film for an ostomy appliance includes a first outer layer, a first barrier layer formed from a first polymer, a second barrier layer formed from a polymer different from the first barrier layer, a tie or adhesive layer between the first barrier layer and the second barrier layer and a second outer layer opposite the first outer layer. The first and second barrier layers have different tensile elongation properties.

Description

MULTI-BARRIER LAYER FILM FOR OSTOMY APPLIANCE BACKGROUND

[0001] The following description relates to ostomy appliances, and more particularly, to a multi-barrier layer film for an ostomy appliance such as an ostomy pouch.

[0002] Ostomy pouches for collecting bodily waste are used by individuals who have had surgery such as a colostomy, ileostomy, or urostomy. An ostomy pouch may be secured to a user via an ostomy appliance that seals around the stoma and is attached to the peristomal skin surface and protects the peristomal surface from exposure to stomal effluent. The attachment to the user is via a skin-friendly adhesive.

[0003] Ostomy pouch material typically includes multiple layers some of which provide specific properties. Specific properties include, among others, mechanical strength, vapor and odor barrier resistant characteristics, liquid and stoma effluent impermeability, and low noise. All of these properties, and others, are important characteristics of ostomy pouch material. In such a material, the layers can be coextruded or joined to one another.

[0004] An issue can arise when such materials are overstretched. These overstretched materials can lose some of the important properties required for an acceptable ostomy pouch. That is, some of these materials do not have sufficient tensile strength to provide a high integrity ostomy pouch.

[0005] Accordingly, there is a need for an ostomy pouch film that provides the vapor and odor barrier, and mechanical performance properties needed for a high integrity ostomy pouch. Desirably, such a material maintains its mechanical, and vapor and odor barrier properties under over stretching conditions. More desirably still, such a material is suitable for deep draw, over-stretching applications while providing vapor and foul odor protection from leak through. BRIEF SUMMARY

[0006] An ostomy pouch film provides a vapor and odor barrier, and mechanical performance properties for a high integrity ostomy pouch. Such a material maintains its mechanical, and vapor and odor barrier properties under over stretching conditions, and is suitable for deep draw, over-stretching applications while providing vapor and foul odorprotection from leak through.

[0007] In one aspect, a multi-barrier layer film for an ostomy appliance includes a first outer layer or skin, a first barrier layer formed from a first polymer, a second barrier layer formed from a polymer different from the first barrier layer, a tie or adhesive layer between the first barrier layer and the second barrier layer and a second outer layer or skin opposite the first outer layer. The first and second barrier layers have different tensile elongation properties.

[0008] In embodiments, a difference in the tensile elongation properties of the first and second barrier layers is at least a factor of 2.

[0009] The first and second barrier layers are different from one another and each are formed from one or a combination of nylon, ethylene vinyl alcohol (EVOH), cyclic olefin copolymers (COCs), polyvinylidene chloride (PVDC), LDPE, medium density polyethylene (MDPE), and polypropylene (PP).

[0010] In embodiments, the first and second outer layers are formed from one or a combination of ethylene vinyl acetate (EVA), ethyl methacrylate (EMA), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene LLDPE (mLLDPE), thermoplastic elastomer (TPE), and thermoplastic olefin (TPO).

[0011] In embodiments, the tie layer is one or a combination of anhydride modified ethylene vinyl acetate, acid modified ethylene vinyl acetate, acrylate modified ethylene vinyl acetate, acid modified ethylene acrylate, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, anhydride grafted ethylene acrylate, anhydride grafted methyl acrylate, anhydride modified low density polyethylene, and anhydride modified linear low density polyethylene.

[0012] In some embodiments the multi-barrier layer film includes 5 layers including a first outer layer, a first barrier layer adjacent the first outer layer, a tie layer adjacent the first barrier layer, a second barrier layer adjacent the tie layer, and a second outer layer adjacent the second barrier layer. The ratio by weight percent of the layers can be: 40% first outer layer; 5% first barrier layer; 5% tie layer; 5% second barrier layer; and 45% second outer layer, or the ratio by weight percent of the layers can be: 40% first outer layer; 8% first barrier layer; 6% tie layer; 8% second barrier layer; and 38% second outer layer.

[0013] In some embodiments, the multi-barrier layer film includes 6 layersincluding a first outer layer, a first tie layer adjacent the first outer layer, a first barrier layer adjacent the first tie layer, a second tie layer adjacent the first barrier layer, a second barrier layer adjacent the second tie layer, and a second outer layer adjacent the second barrier layer. The ratio by weight percent of the layers can be: 40% first outer layer; 5% first tie layer; 5% first barrier layer; 5% second tie layer; 5% second barrier layer; and 40% second outer layer, or the ratio by weight percent of the layers can be: 35% first outer layer; 6% first tie layer; 8% first barrier layer; 6% second tie layer; 8% second barrier layer; and 37% second outer layer.

[0014] In some embodiments the multi-barrier layer film includes 7 layers including a first outer layer, a first tie layer adjacent the first outer layer, a first barrier layer adjacent the first tie layer, a second tie layer adjacent the first barrier layer, a second barrier layer adjacent the second tie layer, a third tie layer adjacent the second barrier layer and a second outer layer adjacent the third tie layer. The ratio by weight percent of the layers can be: 40% first outer layer; 5% first tie layer; 5% a first barrier layer; 5% second tie layer; 5% second barrier layer; 5% third tie layer, and 35% second outer layer, or the ratio by weight percent of the layers can be: 35% first outer layer; 6% first tie layer; 8% a first barrier layer; 6% second tie layer; 8% second barrier layer; 6% third tie layer, and 31% second outer layer.

[0015] In some embodiments the multi-barrier layer film includes 7 layers including a first outer layer, a first barrier layer adjacent the first outer layer, a first tie layer adjacent the first barrier layer, a second barrier layer adjacent the first tie layer, a second tie layer adjacent the second barrier layer, a third barrier layer adjacent the second tie layer and a second outer layer adjacent the third barrier layer. The ratio by weight percent of the layers can be: 40% first outer layer; 5% first barrier layer; 5% a first tie layer; 5% second barrier layer; 5% second tie layer; 5% third barrier layer, and 35% second outer layer, or the ratio by weight percent of the layers can be: 30% first outer layer; 8% first barrier layer; 6% a first tie layer; 8% second barrier layer; 6% second tie layer; 8% third barrier layer, and 34% second outer layer.

[0016] In embodiments, the layers adjacent one another are compatible. The layers can be bonded to one another by an adhesive polymer. The outer layers can be formed from the same material or can be formed from different materials. The tie layers can be formed from the same material or can be formed from different materials.

[0017] The foregoing general description and the following detailed descriptionare examples only and are not restrictive of the present disclosure. Other aspects, objectives and advantages will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The benefits and advantages of the present embodiments will become more readily apparent to those of ordinary skill in the relevant art after reviewing the following detailed description and accompanying drawings, wherein:

[0019] FIG.1 is a schematic cross-sectional illustration of an embodiment of a multi-barrier layer film for an ostomy appliance according to the present disclosure, the film being a 5 layer film;

[0020] FIG.2 is a schematic cross-sectional illustration of another embodiment of a multi-barrier layer film for an ostomy appliance according to the present disclosure, the film being a 6 layer film;

[0021] FIG.3 is a schematic cross-sectional illustration of still another embodiment of a multi-barrier layer film for an ostomy appliance according to the present disclosure, the film being a 7 layer film;

[0022] FIG.4 is a schematic cross-sectional illustration of yet another embodiment of a multi-barrier layer film for an ostomy appliance according to the present disclosure, the film being another 7 layer film; and

[0023] FIGS.5a-5c illustrate the multi-barrier film being bent into different configurations in which it maintains its mechanical, and vapor and odor barrier properties.

[0024] In the figures, the thicknesses of the various layers are shown for illustration purposes and are not intended to reflect actual thicknesses of the layers. That is, the thicknesses of the layers are in no way, and should not be inferred to be, to scale. DETAILED DESCRIPTION

[0025] While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described presently preferred embodiments with the understanding that the present disclosure is to be considered anexemplification and is not intended to limit the disclosure to the specific embodiments illustrated.

[0026] Referring now to the figures, and in particular to FIG.1, there is shown an embodiment of a multi-barrier layer film 10 for an ostomy appliance. The film 10 includes at least two barrier layers 12, 14. The barrier layers 12, 14 provide, among other things, vapor and odor barrier properties to contain vapors and odors that are associated with stomal effluent. The multi-barrier layer film 10 also provides the desired mechanical performance properties under over stretching conditions.

[0027] In embodiments, the two or more barrier layers 12, 14 include at least two different polymers having distinct barrier properties and tensile elongation. In embodiments, a tie layer 16 can be applied between adjacent barrier layers 12, 14. The tie layer 16 can be a polymer material. A modified polymer may be formulated in the barrier layer 12, 14 polymers for improved adhesion with the tie layer 15 polymers. In embodiments, the difference in the elongations of the barrier layer 12, 14 polymers are at least a factor of two. That is, the difference in the elongations of the barrier layer 12, 14 polymers is at least two times. Such multilayer polymers are suitable for a deep draw, over-stretching application while providing optimal vapor and odor protection.

[0028] The film 10 can be thermoformed or stretched to at least two times its original dimension at different temperatures for a 2-piece drum head of soft convex and firm convex skin adhesive wafer application without losing is foul vapor and odor resistance and technical properties. The barrier layers 12, 14 are bonded together using one or more tie layer 16 or adhesive polymers. The skin layers 18, 20 are heat sealable or adhesive bondable to other components, such as flanges and the like, of the ostomy pouch.

[0029] Various structures are contemplated for the multi-barrier film 10. For example, five, six and seven layer films (10, 110, 210, 310) are contemplated. In one example of a 5 layer film 10, as seen in FIG.1, the film 10 includes the following layers: skin 18 / barrier 1 12 / tie 16 / barrier 214 / skin 20. It will be understood that the “skin’ layers are the outer layers of the film. In one example of a 6 layer film 110, the film 110 includes the following layers: skin 118 / tie 116 / barrier 1112 / tie 116 / barrier 2114 / skin 120. In one example of a 7 layer film 210, the film 210 includes the following layers: skin 218 / tie 216 / barrier 1212 / tie 216 / barrier 2214 / tie216 / skin 220. In another example of a 7 layer film 310, the film 310 includes the following layers: skin 318 / barrier 1312 / tie 316 / barrier 2314 / tie 316 / barrier 3322 / skin 320. It will be appreciated that the skin layers 18, 118, 218, 318, 20, 120, 220, 320 are the outer layers of the respective films 10, 110, 210, 310.

[0030] In the above-noted 5 layer film 10 example, the ratios, by weight percent, of the various layers can be, following the structure above, for example: 40 / 5 / 5 / 5 / 45 or 40 / 8 / 6 / 8 / 38. In the above-noted 6 layer film 110, the ratios, by weight percent of the various layers can be, following the structure above, for example: 40 / 5 / 5 / 5 / 5 / 40 or 35 / 6 / 8 / 6 / 8 / 37. In the first above-noted 7 layer film 210, the ratios, by weight percent of the various layers can be, following the structure above, for example: 40 / 5 / 5 / 5 / 5 / 5 / 35 or 35 / 6 / 8 / 6 / 8 / 6 / 31, and in the second above-noted 7 layer film 310, the ratios, by weight percent of the various layers can be, following the structure above, for example: 40 / 5 / 5 / 5 / 5 / 5 / 35 or 30 / 8 / 6 / 8 / 6 / 8 / 34.

[0031] Suitable polymers for the skin layers 18, 118, 218, 318, 20, 120, 220, 320 include but are not limited to: ethylene vinyl acetate (EVA), ethyl methacrylate (EMA), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene LLDPE (mLLDPE), thermoplastic elastomer (TPE), and thermoplastic olefin (TPO). Other suitable polymers for the skin layer will be recognized by those skilled in the art.

[0032] Suitable polymers for the barrier layers 12, 112, 212, 312, 14, 114, 214, 314, 322 include but are not limited to: nylon, ethylene vinyl alcohol (EVOH), cyclic olefin copolymers (COCs), polyvinylidene chloride (PVDC), LDPE, medium density polyethylene (MDPE), and polypropylene (PP). Other suitable polymers for the barrier layers will be recognized by those skilled in the art.

[0033] Suitable polymers for the tie layer 16, 116, 216, 316 include, but are not limited to: anhydride modified ethylene vinyl acetate, acid modified ethylene vinyl acetate, acrylate modified ethylene vinyl acetate, acid modified ethylene acrylate, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, anhydride grafted ethylene acrylate, anhydride grafted methyl acrylate, anhydride modified low density polyethylene, and anhydride modified linear low density polyethylene. Other suitable polymers for the tie layer will be recognized by those skilled in the art.

[0034] Some other examples of 6 layer films include:EVA / EVOH / tie / nylon / tie / EVA, EVA / EVOH / tie / COC / tie / EVA, and EVA / EVOH / tie / PVDC / tie / EVA. Some other examples of 7 layer films include: EVA / tie / PVDC / tie / nylon / tie / EVA, EVA / tie / COC / tie / nylon / tie / EVA, EVA / EVOH / tie / nylon / tie / mLLDPE, and EVA / tie / PVDC / tie / nylon / tie / mLLDPE.

[0035] Examples of some barrier layer 12 / 14, 112 / 114, 212 / 214, 312 / 314 / 322 polymers having different elongations include: amorphous nylon 20%, EVOH 180-350%, cyclic olefin copolymer (COC) 2-5%, nylon 12 flexible 300-340%, PVDC 160-250%, and PET 30- 70%.

[0036] It will be understood by those skilled in the art that the materials of each layer must be compatible with the materials of each layer to which it is adjacent. It will also be understood by those skilled in the art that the first and second skin or outer layers 18 / 20, 118 / 120, 218 / 220, 318 / 320 can be formed from the same material / polymer or can be formed from different materials / polymers. Likewise, the tie layers 16, 116, 216, 316 can be formed from the same material / polymer or can be formed from different materials / polymers.

[0037] It will be appreciated that the present multi-barrier layer film 10, 110, 210, 310 for an ostomy pouch, which includes at least two different and distinct barrier layers 12 / 14, 112 / 114, 212 / 214, 312 / 314 / 322 provides the vapor and odor barrier, and mechanical performance, e.g., elongation and strength, properties needed for a high integrity ostomy pouch. The presently described materials maintain their mechanical, and vapor and odor barrier properties under over stretching conditions. Such materials are suitable for deep draw, over- stretching applications while providing foul vapor and odor protection from leak through.

[0038] All patents referred to herein, are hereby incorporated herein in their entirety, by reference, whether or not specifically indicated as such within the text of this disclosure. In addition, it is understood that terminology referring to directions or relative orientations, such as, but not limited to, “forward” “rearward” “inner” “outer” “upper” “lower” “raised” “lowered” “top” “bottom” “above” “below” “alongside” “left” and “right” are used for purposes of example and do not limit the scope of the subject matter described herein to such orientations or relative positioning.

[0039] In the present disclosure, the words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, whereappropriate, include the singular.

[0040] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present disclosure. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

CLAIMS What is claimed is:

1. A multi-barrier layer film for an ostomy appliance, comprising: a first outer layer; a first barrier layer formed from a first polymer; a second barrier layer formed from a polymer different from the first barrier layer; a tie or adhesive layer between the first barrier layer and the second barrier layer; and a second outer layer opposite the first outer layer, wherein the first and second barrier layers have different tensile elongation properties.

2. The multi-barrier layer film of claim 1, wherein a difference in the tensile elongation properties of the first and second barrier layers is at least a factor of 2.

3. The multi-barrier layer film of claim 1, wherein the first and second barrier layers are different from one another and each are formed from one or a combination of: nylon, ethylene vinyl alcohol (EVOH), cyclic olefin copolymers (COCs), polyvinylidene chloride (PVDC), LDPE, medium density polyethylene (MDPE), and polypropylene (PP).

4. The multi-barrier layer film of any one of claims 1-3, wherein the first and second outer layers are formed from one or a combination of ethylene vinyl acetate (EVA), ethyl methacrylate (EMA), low density polyethylene (LDPE), linear low density polyethylene (LLDPE), metallocene LLDPE (mLLDPE), thermoplastic elastomer (TPE), and thermoplastic olefin (TPO).

5. The multi-barrier layer film of any one of claims 1-4, wherein the tie layer is one or a combination of anhydride modified ethylene vinyl acetate, acid modified ethylene vinyl acetate, acrylate modified ethylene vinyl acetate, acid modified ethylene acrylate, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, anhydride grafted ethylene acrylate, anhydride grafted methyl acrylate, anhydride modified low density polyethylene, and anhydride modified linear low density polyethylene.

6. The multi-barrier layer film of any one of claims 1-4, wherein the multi-barrier layer film includes 5 layers including the first outer layer, the first barrier layer adjacent the first outer layer, the tie layer adjacent the first barrier layer, the second barrier layer adjacent the tie layer, and the second outer layer adjacent the second barrier layer.

7. The multi-barrier layer film of claim 6, wherein the ratio by weight percent of the layers are: 40% first outer layer; 5% first barrier layer; 5% tie layer; 5% second barrier layer; and 45% second outer layer, or 40% first outer layer; 8% first barrier layer; 6% tie layer; 8% second barrier layer; and 38% second outer layer.

8. The multi-barrier layer film of any one of claims 1-4, wherein the multi-barrier layer film includes 6 layers including the first outer layer, a first tie layer adjacent the first outer layer, the first barrier layer adjacent the first tie layer, a second tie layer adjacent the first barrier layer, the second barrier layer adjacent the second tie layer, and the second outer layer adjacent the second barrier layer.

9. The multi-barrier layer film of claim 8, wherein the ratio by weight percent of the layers are: 40% first outer layer; 5% first tie layer; 5% first barrier layer; 5% second tie layer; 5% second barrier layer; and 40% second outer layer, or 35% first outer layer; 6% first tie layer; 8% first barrier layer; 6% second tie layer; 8% second barrier layer; and 37% second outer layer.

10. The multi-barrier layer film of any one of claims 1-4, wherein the multi-barrier layer film includes 7 layers including the first outer layer, a first tie layer adjacent the first outer layer, the first barrier layer adjacent the first tie layer, a second tie layer adjacent the first barrier layer, the second barrier layer adjacent the second tie layer, a third tie layer adjacent the second barrier layer and the second outer layer adjacent the third tie layer.

11. The multi-barrier layer film of claim 10, wherein the ratio by weight percent of the layers are: 40% first outer layer; 5% first tie layer; 5% a first barrier layer; 5% second tielayer; 5% second barrier layer; 5% third tie layer, and 35% second outer layer, or 35% first outer layer; 6% first tie layer; 8% a first barrier layer; 6% second tie layer; 8% second barrier layer; 6% third tie layer, and 31% second outer layer.

12. The multi-barrier layer film of any one of claims 1-4, wherein the multi-barrier layer film includes 7 layers including the first outer layer, the first barrier layer adjacent the first outer layer, a first tie layer adjacent the first barrier layer, the second barrier layer adjacent the first tie layer, the second tie layer adjacent the second barrier layer, a third barrier layer adjacent the second tie layer and the second outer layer adjacent the third barrier layer.

13. The multi-barrier layer film of claim 12, wherein the ratio by weight percent of the layers are: 40% first outer layer; 5% first barrier layer; 5% a first tie layer; 5% second barrier layer; 5% second tie layer; 5% third barrier layer, and 35% second outer layer, or 30% first outer layer; 8% first barrier layer; 6% a first tie layer; 8% second barrier layer; 6% second tie layer; 8% third barrier layer, and 34% second outer layer.

14. The multi-barrier layer film of any one of claims 1-13, wherein the layers adjacent one another are compatible.

15. The multi-barrier layer film of any one of claims 1-14, wherein the layers are bonded to one another by an adhesive polymer.

16. The multi-barrier layer film of any one of claims 1-15, wherein the outer layers are formed from the same material.

17. The multi-barrier layer film of any one of claims 1-15, wherein the outer layers are formed from different materials.

18. The multi-barrier layer film of any one of claims 1-17, wherein the tie layers are formed from the same material.

19. The multi-barrier layer film of any one of claims 1-17, wherein the tie layers are formed from different materials.

Images