Multilayer film including foam layer and ostomy products made therefrom

Abstract

An ostomy appliance includes a multilayer composite film comprising at least one foam layer. An outer foam layer can function as a skin contact layer providing comfort and softness characteristics that are comparable to a nonwoven comfort layer. Preferably, at least one foam layer includes a vinyl-bond rich triblock copolymer and provides sound absorbing properties. The multilayer composite film can also include at least one layer comprising a filler to further enhance sound absorbing properties.

Claims

1. A sound insulating ostomy pouch, comprising: a first wall; a second wall, wherein the first wall and the second wall are sealed along their peripheral edges to define a cavity; and wherein only one of the first wall and the second wall is formed of a composite film including at least one foam layer comprising a vinyl-bond rich triblock copolymer, and wherein the composite film is formed from a plurality of coextruded, non-laminated layers, wherein the composite film further includes an odor barrier layer, and wherein the at least one foam layer includes an outer foam layer configured to contact a user's skin when the ostomy pouch is attached to the user.

2. The sound insulating ostomy pouch of claim 1, wherein the at least one foam layer is formed from a blend comprising a non-hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer and a polyolefin based material.

3. The sound insulating ostomy pouch of claim 1, wherein the at least one foam layer is formed from a blend comprising a hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer and a polyolefin based material.

4. The sound insulating ostomy pouch of claim 1, wherein the composite film further includes a seal layer.

5. The sound insulating ostomy pouch of claim 4, wherein the composite film has a six layer construction including seal layer/tie layer/odor barrier layer/tie layer/inner foam layer/outer foam layer.

6. The sound insulating ostomy pouch of claim 4, wherein the composite film has a seven layer construction including seal layer/tie layer/odor barrier layer/tie layer/foam layer/foam layer/outer foam layer.

7. The sound insulated ostomy pouch of claim 1, wherein the at least one foam layer includes an outer foam layer, wherein the sound insulated ostomy pouch is configured such that the outer foam layer is in contact with user's skin when the sound insulated ostomy pouch is attached to the user, wherein the outer foam layer comprises a slip agent and has an open-cell construction.

8. The sound insulated ostomy pouch of claim 1, wherein the composite film further includes at least one layer comprising mica, barium sulfate, or talc.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) 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:

(2) FIG. 1 is a cross-sectional illustration of a prior art ostomy appliance;

(3) FIG. 2 is a cross-sectional illustration of an ostomy pouch according to an embodiment of the present disclosure;

(4) FIG. 3 is a cross-sectional illustration of a six-layer composite film according to an embodiment;

(5) FIG. 4 is a cross-sectional illustration a seven-layer composite film according to an embodiment;

(6) FIG. 5 is a graph showing sound transmission loss data for composite film samples:

(7) FIG. 6 is a cross-sectional illustration of a five-layer composite film according to an embodiment;

(8) FIG. 7 is a cross-sectional illustration of an ostomy pouch according to another embodiment of the present disclosure; and

(9) FIG. 8 is a graph showing film noise data in a-weighted sound pressure level for composite film samples;

(10) FIG. 9 is a graph showing film noise data in mean overall sound pressure level for composite film samples;

(11) FIG. 10 is a graph showing sound transmission loss data for laminate samples including barium sulfate; and

(12) FIG. 11 is graph showing sound transmission loss data for laminate samples including talc.

DETAILED DESCRIPTION

(13) While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiment illustrated.

(14) FIG. 1 is a cross-sectional illustration of a prior art one-piece ostomy pouch 10. The ostomy pouch 10 generally includes a pouch 12 and a skin barrier 14. The pouch 12 includes first and second opposing walls 16, 18, which are sealed around peripheral edges 20 thereof to define a cavity 22 for collecting body waste. The pouch 12 also includes a first nonwoven layer 24 attached to the first wall 16, and a second nonwoven layer 26 attached to the second wall 18. The nonwoven layers 24, 26 are attached to the respective walls 16, 18 via heat sealing or an adhesive. Each of the first and second walls 16, 18 is formed of a suitable odor barrier film, which may be a single layer film or a multilayer film.

(15) Typically, each side of the pouch is configured to have a total thickness of about 10 mil to about 12 mil. For example, each side includes a nonwoven layer heat sealed to a wall, in which the wall has a thickness of about 3 mil and the nonwoven layer has a thickness of about 8 mil to provide a total thickness of about 11 mil. In another example, each side includes a nonwoven layer attached to a wall by an adhesive therebetween, in which the wall has a thickness of about 2.25 mil, and the adhesive has a thickness of about 1.1 mil, and the nonwoven layer has a thickness of about 8 mil to provide a total thickness of about 11.35 mil.

(16) FIG. 2 is a cross-sectional illustration of an embodiment of a one-piece ostomy pouch 110. The ostomy pouch 110 is similarly configured to the ostomy pouch 10 of FIG. 1, and generally includes a pouch 112 and a skin barrier 114. The pouch 112 includes first and second opposing walls 116, 118, which are sealed around peripheral edges 120 thereof by heat sealing or by any other suitable means to define a cavity 122 therebetween for collecting body waste.

(17) Each of the first and second walls 116, 118 is formed of a multilayer composite film 124. The composite film 124 is designed to replace the film/nonwoven construction or the film/adhesive/nonwoven construction of prior art pouches. The composite film 124 includes at least one odor barrier film layer and at least one foam layer, which are coextruded. Thus, manufacturing processes of the pouch can be simplified by reducing number of suppliers required for film, nonwoven and adhesive, and eliminating steps for laminating or heat sealing the layers, which in turn provides cost savings. The foam layer of the composite film is configured to have softness sufficient for skin contact to replace the nonwoven layer of prior art pouches. The foam layer can be configured to have a skin contact quality soft feel by using rubbery resins and fine foam cells. Preferably, the foam layer also provides sound absorbing characteristics.

(18) Preferably, the composite film 124 is configured to have a thickness similar to the total thickness of the film/nonwoven construction or the film/adhesive/nonwoven construction of prior art ostomy pouches. For example, the composite film 124 has an overall thickness of about 10 mil to about 12 mil. The composite film 125 can also be configured to have thinner thicknesses, for example, about 7 mil, to provide a lower cost composite film which still has similar softness and film characteristics as the thicker composite films. In some embodiments, the first wall 116 and the second wall 118 can be formed of different composite films, or only one of the first and second walls 116, 118 can be formed of a composite film.

(19) FIG. 3 is a cross-sectional illustration of an embodiment of the composite film 124. The composite film 124 has a six-layer construction including a seal layer 126, tie layers 128, 132, a barrier layer 130, and foam layers 134, 136. In this embodiment, the composite film 124 has the structure ABCBDE, where A represents the seal layer, B represents the tie layers, C represents the barrier layer, D represents an inner foam layer, and E represents an outer foam layer.

(20) In other embodiments, the composite film can include more than six layers or less than six layers. For example, a composite film can have a five-layer construction including a barrier layer, two tie layers, a seal layer, and one foam layer (i.e. ABCBE). FIG. 6 is a cross-sectional illustration of a five-layer composite film embodiment including a seal layer 162, tie layers 164, 168, a barrier layer 166, and a foam layer 170. The composite film 160 has a seal/tie/barrier/tie/foam construction. Alternatively, a composite film can have a seven-layer construction including a barrier layer, two tie layers, a seal layer, and three foam layer (e.g. ABCBDDE).

(21) The seal layer 126 is formed of a material having suitable heat sealability, such that the seal layers of the first and second walls 116, 118 can be heat sealed along their perimeter to form the pouch 112. Suitable materials for the seal layer 126 include copolymers of ethylene with vinyl esters, such as vinyl acetate copolymer (EVA) and copolymers of ethylene methyl acrylate (EMA). Suitable EVA copolymers can contain about 10 wt. % to 35 wt. % vinyl acetate and more preferably, about 18 wt. % vinyl acetate, by weight of the copolymer. One such material is available from ExxonMobil as product Escorene Ultra FL00218. Such a material has a melting point temperature of 86 C. and a Shore A hardness of about 91. EVA is known to exhibit the necessary characteristics for joining to another EVA member, as by heat sealing, to provide an air-tight, liquid-tight seal at the joint or seal. EVA materials can be blended to facilitate formation and film extrusion. For example, an EVA blend can have about 98 percent by weight (wt. %) EVA with about 2 wt. % anti-block and slip additives, in an EVA carrier. One suitable additive is available from A. Schulman Inc., as Polybatch SAB-1982VA.

(22) Suitable EMA copolymers can include about 10 wt. % to about 35 wt. % of the methyl acrylate and preferably about 18.5 wt. % to about 30 wt. % methyl acrylate. Such EMA copolymers typically have melting point temperatures of about 85 C. to 87 C. and a Shore A hardness of about 73 and Shore D hardness of about 20 to 25. Such materials are available from Arkema Inc. as Lotryl18AM02 and from DuPont as Elvaloy1330AC. The EMA resins can also be blended with anti-block and slip additives in an EVA carrier. One suitable material for blending is the aforementioned Polybatch SAB-1982VA. Such a blend can have, for example EMA at about 98 wt. %, with about 2 wt. % Polybatch SAB-1982VA anti-block and slip additive.

(23) The seal layer 126 can also be formed of blends of EVA copolymer (e.g. EscoreneFL00218 present at 49 wt. %) and PP-elastomer (e.g. Versify2200 present at 49 wt. %) with anti-block and slip additives, or blends of EMA copolymer (e.g. Elvaloy1330AC present at 49 wt. %) and PP-elastomer (e.g. Versify2200 present at 49 wt. %) also with anti-block and slip additives. PP-elastomers such as Versify from Dow, Vistamaxx from Exxon, and Notio from Mitsui are also suitable.

(24) In addition to heat sealability, the seal layer 126 can also provide sound absorbing properties. In such an embodiment, the seal layer 126 can comprise a vinyl-bond rich triblock copolymer, such as Hybrar, to enhance sound absorbing properties and mechanical properties of the composite film. For example, the seal layer 126 can be formed from a blend of a non-hydrogenated styrene isoprene copolymer (Hybrar 5127), a PP-elastomer (Vistamaxx), and an EMA (Lotryl 20MA08).

(25) On either side of the barrier layer 130 are the tie layers 128, 132. The tie layers facilitate adhesion of the barrier layer 130 to the remainder of the composite film structure. The seal layer 126 and the inner foam layer 134 are adjacent to the tie layers 128, 132, respectively. The tie layers 128, 132 can be formed of the same material or different materials. Suitable materials for the ties layers 128, 132 include maleated polyolefins, such as a maleated ethylene methyl acrylate copolymers having maleic anhydride present at about 0.3 wt. % and methyl acrylate present at about 20 wt. % of the resin. One such material is available from Arkema, Inc. as Lotader4503.

(26) The barrier layer 130 can be formed from various materials having gas barrier properties. Preferably, the barrier layer 130 is formed from a non-chlorine containing polymer that is substantially impermeable to malodor causing compounds typically encountered in ostomy pouches. Such malodor causing compounds can include sulfur containing compounds and indoles. Suitable barrier layer materials include resins such as amorphous polyamide (nylon) resin, and an anhydride-modified olefinic polymer or copolymer, or an epoxy modified olefin polymer or copolymer. For example, the barrier layer 130 can be formed from a blend of an amorphous polyamide, such as Selar PA3426R, by DuPont Company, and a functionalized rubber blend or compound, such as Lotader 4720.

(27) The inner foam layer 134 and the outer foam layer 136 can be formulated from the same material or different materials. For example, the inner foam layer 134 can be formed from a polyolefin with a blowing agent and a color additive, and the outer foam layer 136 can be formed from the same polyolefin with a blowing agent, and slip and antiblock agents. Ethylene based polymers, such as copolymers of ethylene with vinyl esters, e.g. EVA and EMA, ethylene-octene (EO) plastomers, and ethylene-propylene (EP) copolymers (PP-elastomer) are suitable for the foam layers. One suitable material is an ethylene vinyl acetate (EVA) copolymer having a vinyl acetate content of about 8 wt. % to 30 wt. %, and preferably about 10 wt. % to about 25 wt. %, a melting point temperature of about 86 C. and a Shore A hardness of about 91, such as EscoreneFL00218, available from ExxonMobil Corporation. Suitable EMA copolymers can include about 10 wt. % to about 35 wt. % methyl acrylate and preferably about 18.5 wt. % to about 30 wt. % methyl acrylate. Such EMA copolymers typically have melting point temperatures of about 85 C. to 87 C., a Shore A hardness of about 73 and Shore D hardness of about 20 to 25. Such materials are available from Arkema Inc. as Lotryl18AM02 and from DuPont as Elvaloy1330AC.

(28) Another suitable material is an EO plastomer having a melting point temperature of about 95 C. and specific gravity of about 0.902, such as Exact 0203 resin, also available from ExxonMobil Corporation, which has a specific gravity of about 0.88 and a Shore A hardness of about 95. Still another suitable resin is an ethylene-propylene copolymer (PP-elastomer) resin. It has excellent compatibility with polypropylene (PP) and polyethylene (PE). One such material is available from Dow Chemical as Versify2200. This resin has melting point of about 82 C., a Shore A hardness of 94 and a Shore D hardness of 42. It has a specific gravity of 0.878. Blends of various PP copolymer resins are also suitable, for example, blends of Versify2200 and Versify3400, which is a similar PP copolymer resin, but has a higher melting point of about 97 C., a Shore A hardness of 72 and a Shore D hardness of 22, and a specific gravity of about 0.865. Suitable blends can have ratios of about 50 percent of Versify2200 to about 75 percent of Versify2200 by weight of the blend. PP-elastomers such as Versify from Dow, Vistamaxx from Exxon, and Notio from Mitsui, and blends thereof are also suitable.

(29) Preferably, the foam layers 134, 136 also provide at least some sound absorbing properties. In such an embodiment, each of the foam layers 134, 136 comprises a vinyl-bond rich triblock copolymer, such as Hybrar from Kuraray Co. Ltd., to enhance mechanical properties and sound absorbing properties of the composite film. For example, each of the foam layers can be formed from a blend comprising a non-hydrogenated vinyl-bond rich styrene-isoprene-styrene (SIS) block copolymer, e.g. Hybrar 5125 and 5127, or a hydrogenated vinyl-bond rich styrene-isoprene-styrene (SIS) block copolymer, e.g. Hybrar 7125, and at least one other polymer, such as EMA (e.g. Lotryl 20MA08).

(30) In one embodiment, the six-layer composite film 124 has a total thickness of about 280 m (11 mil), in which the seal layer 126 has a thickness of about 64 m, each of the tie layers 128, 132 has a thickness of about 4 m, the barrier layer 130 has a thickness of about 4 m, the inner foam layer 134 has a thickness of about 140 m, and the outer foam layer 136 has a thickness of about 64 m.

(31) In this embodiment, the seal layer 126 is formed a blend comprising about 49 wt. % of EVA copolymer (Escorene FL00218), about 49 wt. % of PP-elastomers (Vistamaxx 3980FL), and about 2 wt. % of a slip and antiblock agent (Polybatch SAB-1982VA). Each of the tie layers 128, 132 is formed from a blend comprising about 80 wt. % EMA (Lotryl 18MA02) and about 20 wt. % MAH grafted LLDPE (Bynel CXA41E710). The barrier layer is formed from a blend comprising about 85 wt. % amorphous polyamide (Selar PA3426R) and 15 wt. % functionalized rubber blend (Lotader 4720). The inner foam layer 134 is formed from a blend comprising about 45 wt. % of EVA copolymer (Escorene FL00218), about 45 wt. % of PP-elastomers (Vistamaxx 3980FL), about 8 wt. % of color masterbatch, and about 2 wt. % of blowing agent (Safoam FP-40 from Reedy International). The outer foam layer 136 is formed from a blend comprising about 48 wt. % of EVA copolymer (Escorene FL00218), about 48 wt. % of PP-elastomers (Vistamaxx 3980FL), about 2 wt. % of blowing agent (Safoam FP-40), and about 2 wt. % of slip and antiblock agent (Polybatch SAB-1982VA). The foam layers 134, 136, particularly the outer foam layer 136, include fine foam cells for soft skin touch feel. Further, the slip agent is added to the blend for the outer foam layer 136 to improve the smooth sleek feel of the foam.

(32) Preferably, the foam layers provide sound absorbing properties in addition to a smooth soft feel for improved comfort for wearers. Thus, at least one foam layer comprises a vinyl-bond rich triblock copolymer such as a non-hydrogenated vinyl-bond rich styrene-isoprene-styrene (SIS) block copolymer, e.g. Hybrar 5125 and 5127, or a hydrogenated vinyl-bond rich styrene-isoprene-styrene (SIS) block copolymer, e.g. Hybrar 7125.

(33) In one embodiment, the six-layer composite film 124 has a total thickness of about 288 m (11.3 mil), in which the seal layer 126 has a thickness of about 20 m, each of the tie layers 128, 132 has a thickness of about 3 m, the barrier layer 130 has a thickness of about 4 m, the inner foam layer 134 has a thickness of about 238 m, and the outer foam layer 136 has a thickness of about 20 m.

(34) In this embodiment, the seal layer 126 is formed from a blend comprising about 49 wt. % of EVA copolymer (Escorene FL00218), about 49 wt. % of PP-elastomers (Vistamaxx 3980FL), and about 2 wt. % of a slip and antiblock agent (Polybatch SAB-1982VA). Each of the tie layers 128, 132 is formed from a blend comprising about 80 wt. % EMA (Lotryl 18MA02) and about 20 wt. % MAH grafted LLDPE (Bynel CXA41E710). The barrier layer 130 is formed from a blend comprising about 85 wt. % amorphous polyamide (Selar PA3426R) and 15 wt. % functionalized rubber blend (Lotader 4720). The inner foam layer 134 is formed from a blend comprising about 47 wt. % of hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), about 47 wt. % of EMA (Lotryl 20MA08), about 4 wt. % of color masterbatch, and about 2 wt. % of blowing agent (Safoam FP-20). The outer foam layer 136 is formed from a blend comprising about 48 wt. % of hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), about 48 wt. % of EMA (Lotryl 20MA08), about 2 wt. % of blowing agent (Safoam FP-20), and about 2 wt. % of slip and antiblock agent (Polybatch SAB-1982VA). Preferably, the foam layers 134, 136 include fine foam cells for soft smooth feel, and open cell structure to maximize sound absorbing properties of the foam layers. Further, the slip agent is added to the blend for the outer foam layer 136 for improved smooth sleek feel of the foam.

(35) In another embodiment, the six-layer composite film 124 has a total thickness of about 288 m (11.3 mil), in which the seal layer 126 has a thickness of about 20 m, each of the tie layers 128, 132 has a thickness of about 3 m, the barrier layer 130 has a thickness of about 40 m, the inner foam layer 134 has a thickness of about 202 m, and the outer foam layer 136 has a thickness of about 20 m. In this embodiment, the barrier layer 130 is formed from a low melting point nylon, and thus, a non-hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 5125 or 5127), which has a lower melting point than the hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), can be used for the foam layers 134, 136. In the previously described embodiment, the amorphous polyamide (Selar PA3426R) used for the barrier layer has a relatively high melt flow temperature, thus requires a relatively high processing temperature. Therefore, the hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer, which has a higher melting point temperature, and is thus more heat stable than the non-hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer, was selected for the foam layers. The non-hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymers can provide additional cost benefits and improved sound absorbing properties in some embodiments.

(36) In this embodiment, the seal layer 126 is formed from a blend comprising about 59 wt. % of EMA (Lotryl 20MA08), about 39 wt. % of PP-elastomers (Vistamaxx 3980FL), and about 2 wt. % of a slip and antiblock agent (Polybatch SAB-1982VA). Each of the tie layers 128, 132 is formed from a blend comprising about 80 wt. % EMA (Lotryl 20MA08) and about 20 wt. % MAH grafted LLDPE (Bynel CXA41E710). The barrier layer 130 is formed from a blend comprising about 85 wt. % low melting point nylon (Grilon BM13 from EMS-Grivory) and 15 wt % functionalized rubber blend (Lotader 4720). The inner foam layer 134 is formed from a blend comprising about 46.5 wt. % of non-hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 5127), about 46.5 wt. % of EMA (Lotryl 20MA08), about 5 wt. % of color masterbatch, and about 2 wt. % of blowing agent (Safoam FP-20). The outer foam layer 136 is formed from a blend comprising about 48 wt. % of non-hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 5127), about 48 wt. % of EMA (Lotryl 20MA08), about 2 wt. % of blowing agent (Safoam FP-20), and about 2 wt. % of slip and antiblock agent (Polybatch SAB-1982VA). Preferably, the foam layers 134, 136 include fine foam cells for soft smooth feel, and open cell structure to maximize sound absorbing properties of the foam layers. Further, the slip agent is added to the blend for the outer foam layer 136 for an improved smooth sleek feel of the foam.

(37) In some embodiments, a composite film includes at least one layer comprising a filler to provide improved sound absorbing or sound deadening properties. Fillers having a platelet shape, such as mica and talc, are preferred. For example, a composite film having improved sound absorbing properties can include at least one sound absorbing foam layer comprising a vinyl-bond rich triblock copolymer and at least one other layer comprising a filler, such as mica, barium sulfate, and/or talc.

(38) In one embodiment, a six-layer composite film 124 (FIG. 3) includes a seal layer comprising a filler. The composite film has a total thickness of about 288 m (11.3 mil) including a seal layer 126 having a thickness of about 25 m, two tie layers 128, 132, each of which having a thickness of about 4 m, a barrier layer 130 having a thickness of about 4 m, an inner foam layer 134 having a thickness of about 166 m, and an outer foam layer 136 having a thickness of about 85 m. The seal layer 126 is formed from a polymer blend comprising about 33.3 wt. % of a EMA/mica blend (the EMA/mica blend includes about 50 wt. % mica (Suzorite 60S from Imerys Pigments) and about 50 wt. % EMA (Lotryl 20MA08)), about 25 wt. % of EMA (Lotryl 20MA08), about 40 wt. % of PP-elastomers (Vistamaxx 3980FL), and about 1.7 wt. % of a slip and antiblock agent (Polybatch SAB-1982VA). Each of the tie layers 128, 132 is formed from a blend comprising about 80 wt % EMA (Lotryl 18MA02) and about 20 wt. % MAH grafted LLDPE (Bynel CXA41E710). The barrier layer 130 is formed from a blend comprising about 85 wt. % amorphous polyamide (Selar PA3426R) and about 15 wt. % functionalized rubber blend (Lotader 4720). The inner foam layer 134 is formed from a blend comprising about 55 wt. % of hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), about 31 wt. % of EMA (EMAC 2207 from West Lake), about 11 wt. % of color masterbatch, and about 3 wt. % of blowing agent (Expancel 950 MB80 from Akzo). The outer foam layer 136 is formed from a blend comprising about 52 wt. % of hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), about 43 wt. % of EMA (Lotryl 20MA08), about 3 wt. % of blowing agent (Expancel 950MB80), and about 2 wt. % of slip and antiblock agent (Polybatch SAB-1982VA).

(39) FIG. 7 is a cross-sectional illustration of a one-piece ostomy pouch 210 according to anther embodiment. The ostomy pouch 210 is similarly configured as the ostomy pouch 110 of FIG. 2, and generally includes a pouch 212 and a skin barrier 214. In this embodiment, a first wall 216 is formed of a composite film 224, and a second wall 218 is formed of a film 226. Further, the ostomy pouch 210 includes a nonwoven layer 228 attached to the second wall 218 to accommodate users who desire characteristics of a nonwoven comfort panel, for example, breathability.

(40) The composite film 224 includes at least one sound absorbing foam layer comprising a vinyl-bond rich triblock copolymer such as a non-hydrogenated vinyl-bond rich styrene-isoprene-styrene (SIS) block copolymer, e.g. Hybrar 5125 and 5127, or a hydrogenated vinyl-bond rich styrene-isoprene-styrene (SIS) block copolymer, e.g. Hybrar 7125. The composite film 224 can have any of the multilayer composite constructions discussed in this disclosure. For example, the composite film 224 can have a six-layer construction including a seal layer, two tie layers, a barrier layer, and two foam layers, as shown in FIG. 3. Alternatively, the composite film 224 can have a five-layer construction as shown in FIG. 6 or a seven-layer construction as shown in FIG. 4

(41) The second wall 218 can be formed of a suitable monolayer or multilayer film, such as a composite film including at least one sound absorbing foam layer comprising a vinyl-bond rich triblock copolymer. For example, the film 226 can be the same composite film as the composite film 224 or a different composite film. In one embodiment, the composite film 224 and the film 226 are the same composite film having a six-layer construction of FIG. 3, which includes two foam layers 134, 136 comprising a vinyl-bond rich triblock copolymer. In another embodiment, the film 226 is a different composite film than the composite film 224. For example, the film 226 can be a thinner composite film than the composite film 224. For example, the composite film 224 can have a thickness of about 11 mil, while the film 226 is a composite film having a thickness of about 7 mil.

(42) Alternatively, the film 226 can be a suitable polymeric film, which does not include a foam layer. The film 226 can be a single layer film or a multilayer film. Preferably, the multilayer film includes at least one odor barrier layer. For example, the film 226 can be a six-layer film having a thickness of about 2.24 mil (57 m) and a seal layer/tie layer/barrier layer/tie layer/inner layer/seal layer construction. In another example, the film 226 can be a seven-layer film having a seal layer/inner layer/tie layer/barrier layer/tie layer/inner layer/seal layer construction. In some embodiments, the multilayer film for the second wall 218 includes at least one layer comprising a vinyl-bond rich triblock copolymer.

(43) Although the embodiments of FIGS. 2 and 7 are a one-piece ostomy appliance with a closed-end pouch, the above discussed multilayer composite films can be used to make other types of ostomy appliances, such as two-piece ostomy appliances and drainable ostomy pouches.

Examples and Test Results

(44) Three composite film samples and a control laminate were prepared and tested for their mechanical and sound absorbing properties. Each of the composite film samples had a total thickness of about 288 m (11.3 mil) and a seven-layer construction (seal layer/tie layer/barrier layer/tie layer/foam layer/foam layer/foam layer). Each of the foam layers included hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125) for sound absorbing properties. The control laminate, which is currently used in some known ostomy pouches, had a total thickness of about 11.3 mil including a PE nonwoven layer, an adhesive layer, and a multilayer barrier film.

(45) TABLE-US-00001 TABLE 1 Composite Film Samples and Control Laminate Sample Code Foam 1 Foam 2 Foam 3 Tie 1 Barrier Tie 2 Seal X3299 85 m 83 m 83 m 4 m 4 m 4 m 25 m 50% Hybrar 65% 65% 80% Lotryl 85% same 50% Lotryl 7125 + 46% Hybrar Hybrar 18MA02 + Selar as 20MA06 + Lotryl 20MA08 + 7125 + 34% 7125 + 34% 20% Bynel PA3426R + Tie 1 48% 2% Safoam EMAC EMAC CXA41E710 15% Vistamaxx FP-20 + 2% 2207 + 1% 2207 + 1% Lotader 3980FL + 2% Polybatch Safoam Safoam 4720 Polybatch SAB-1982VA FP-20 FP-20 SAB-1982VA X3300 85 m 83 m 83 m 4 m 4 m 4 m 25 m 50% Hybrar 65% 65% 80% Lotryl 85% same 50% Lotryl 7125 + 46% Hybrar Hybrar 18MA02 + Selar as 20MA08 + Lotryl 20MA08 + 7125 + 34% 7125 + 34% 20% Bynel PA3426R + Tie 1 48% 2% Safoam EMAC EMAC CXA41E710 15% Vistamaxx FPE-20 + 2% 2207 + 1% 2207 + 1% Lotader 3980FL + 2% Polybatch Safoam Safoam 4720 Polybatch SAB-1982VA FPE-20 FPE-20 SAB-1982VA X3301 85 m 83 m 83 m 4 m 4 m 4 m 25 m 50% Hybrar 65% 65% 80% Lotryl 85% same 50% Lotryl 7125 + 46% Hybrar Hybrar 18MA02 + Selar as 20MA08 + Lotryl 20MA08 + 7125 + 34% 7125 + 34% 20% Bynel PA3426R + Tie 1 48% 2% EMAC EMAC CXA41E710 15% Vistamaxx Expancel 2207 + 1% 2207 + 1% Lotader 3980FL + 2% 950MB80 + 2% Expancel Expancel 4720 Polybatch Polybatch 950MB80 950MB80 SAB-1982VA SAB-1982VA Nonwoven Adhesive 57 m (2.24 mil) 6-layer film Control 203.2 m 28 m Seal Inner Tie 1 Barrier Tie 2 Seal (8 mil) (1.1 mil) 97.5% 87%-89.5% 80% 85% same 97.5% PE adhesive Escorene Escorene Lotryl Selar as Escorene nonwoven FL00218 + FL00218 + 18MA02 + PA3426R + Tie 1 FL00218 + 2.5% 10.5%-13% 20% 15% 2.5% Polybatch Schulman Bynel Lotader Polybatch SAB- T92030 CXA- 4720 SAB- 1982VA Beige 41E710 1982VA

(46) As summarized in Table 1, Sample X3299 is a seven-layer composite film 140 (FIG. 4) having a foam layer 1/foam layer 2/foam layer 3/tie layer 1/barrier layer/tie layer 2/seal layer construction. The seal layer 142 has a thickness of about 25 m, and is formed of a blend comprising about 50 wt. % of EMA (Lotryl 20MA08), about 48 wt. % of PP-elastomers (Vistamaxx 3980FL), and about 2 wt. % of a slip and antiblock agent (Polybatch SAB-1982VA). Each of the tie layer 1 (148) and tie layer 2 (144) has a thickness of about 4 m, and is formed from a blend comprising about 80 wt. % EMA (Lotryl 18MA02) and about 20 wt. % MAH grafted LLDPE (Bynel CXA41E710). The barrier layer 146 has a thickness of about 4 m, and is formed from a blend comprising about 85 wt. % amorphous polyamide (Selar PA3426R) and about 15 wt. % functionalized rubber blend (Lotader 4720). Each of the foam layer 2 (152) and the foam layer 3 (150) has a thickness of about 83 m, and is formed from a blend comprising about 65 wt. % of hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), about 34 wt. % of EMA (EMAC 2207), and about 1 wt. % of blowing agent (Safoam FP-20). The foam layer 1 (154) has a thickness of about 85 m, and is formed from a blend comprising about 50 wt. % of hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), about 46 wt. % of EMA (Lotryl 20MA08), about 2 wt. % of blowing agent (Safoam FP-20), and about 2 wt. % of slip and antiblock agent (Polybatch SAB-1982VA). Thus, the composite film 140 of Sample X3299 has a total thickness of about 288 m (11.3 mil).

(47) Sample X3300 is also a seven-layer composite film 140 having the same layer construction as Sample X3299, which is illustrated in FIG. 4. The seal layer 142 has a thickness of about 25 m, and is formed from a blend comprising about 50 wt. % of EMA (Lotryl 20MA08), about 48 wt. % of PP-elastomers (Vistamaxx 3980FL), and about 2 wt. % of a slip and antiblock agent (Polybatch SAB-1982VA). Each of the tie layer 1 (148) and tie layer 2 (144) has a thickness of about 4 m, and is formed from a blend comprising about 80 wt. % EMA (Lotryl 18MA02) and about 20 wt. % MAH grafted LLDPE (Bynel CXA41E710). The barrier layer 146 has a thickness of about 4 m, and is formed from a blend comprising about 85 wt. % amorphous polyamide (Selar PA3426R) and about 15 wt. % functionalized rubber blend (Lotader 4720). Each of the foam layer 2 (152) and the foam layer 3 (150) has a thickness of about 83 m, and is formed from a blend comprising about 65 wt. % of hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), about 34 wt. % of EMA (EMAC 2207), and about 1 wt. % of blowing agent (Safoam FPE-20). The foam layer 1 (154) has a thickness of about 85 m, and is formed from a blend comprising about 50 wt. % of hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), about 46 wt. % of EMA (Lotryl 20MA08), about 2 wt. % of blowing agent (Safoam FPE-20), and about 2 wt. % of slip and antiblock agent (Polybatch SAB-1982VA). Thus, the composite film 140 of Sample X3300) has a total thickness of about 288 m (11.3 mil).

(48) Sample X3301 is also a seven-layer composite film 140 having the same layer construction as Sample X3299, which is illustrated in FIG. 4. The seal layer 142 has a thickness of about 25 m, and is formed from a blend comprising about 50 wt. % of EMA (Lotryl 20MA08), about 48 wt. % of PP-elastomers (Vistamaxx 3980FL), and about 2 wt. % of a slip and antiblock agent (Polybatch SAB-1982VA). Each of the tie layer 1 (148) and tie layer 2 (144) has a thickness of about 4 m, and is formed from a blend comprising about 80 wt. % EMA (Lotryl 18MA02) and about 20 wt. % MAH grafted LLDPE (Bynel CXA41E710). The barrier layer 146 has a thickness of about 4 m, and is formed from a blend comprising about 85 wt. % amorphous polyamide (Selar PA3426R) and about 15 wt. % functionalized rubber blend (Lotader 4720). Each of the foam layer 2 (152) and the foam layer 3 (150) has a thickness of about 83 m, and is formed from a blend comprising about 65 wt. % of hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), about 34 wt. % of EMA (EMAC 2207), and about 1 wt. % of blowing agent (Expancel 950MB80 from Akzo). The foam layer 1 (154) has a thickness of about 85 m, and is formed from a blend comprising about 50 wt. % of hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 7125), about 46 wt. % of EMA (Lotryl 20MA08), about 2 wt. % of blowing agent (Expancel 950MB80), and about 2 wt. % of slip and antiblock agent (Polybatch SAB-1982VA). Thus, the composite film 140 of Sample X3301 has a total thickness of about 288 m (11.3 mil).

(49) The layers of Samples X3299, X3300, and X3301 were coextruded to form the composite film 140. Each layer was extruded using a separate extruder with appropriate settings for the particular polymer blend.

(50) The control laminate had a thickness of about 11.3 mil, and included a PE nonwoven laminated to a six-layer odor barrier film with an adhesive between them. The six-layer odor barrier film had a thickness of about 2.24 mil (57 m), and a seal layer/tie layer/barrier layer/tie layer/inner layer/seal layer construction. Each of the seal layers was formed from a blend of about 97.5% wt. EVA copolymer (Escorene FL00218 available from ExxonMobil Corporation) and about 2.5 wt. % anti-block/slip additive (Polybatch SAB1982VA available from Schulman Inc.) Each of the tie layers was formed from a blend of about 80 wt. % EMA (Lotryl 18MA02) and about 20 wt. % MAH grafted LLDPE (Bynel CXA41E710.) The barrier layer was formed from a blend of about 85 wt. % of an amorphous polyamide (Selar PA3426R) and about 15 wt. % functionalized rubber blend (Lotader 4720.) The inner layer was formed from a blend of about 87 wt. %-89.5 wt. % EVA copolymer (Escorene FL00218) and about 10.5 wt. %-13 wt. % Schulman T92030 Beige.

(51) Mechanical properties of the sample composites and the control laminate were evaluated, and their data is summarized in Table 2.

(52) TABLE-US-00002 TABLE 2 Mechanical Properties of Samples X3299 X3300 X3301 Control Actual Total Thickness 280 288 294 280 (m) Elmendorf Tear at 800 mm MD 23154 24036 14058 (mN) CD 13327 15872 9847 Elmendorf Tear at 800 mm MD 2049 2127 1244 (mN/mil) CD 1179 1405 871 Elmendorf Tear at 800 mm MD 209 217 127 (gf/mil) CD 120 143 89 Tensile Strength (N/mm.sup.2) MD 6.9 6.6 4.3 6.9 CD 6.7 6.5 4.0 2.8 Tensile Strength (psi) MD 1000 951 626 1001 CD 965 937 586 405 Tensile Yield (N/mm.sup.2) MD 2.8 2.1 2.3 3.6 CD 2.3 2.2 1.7 2.5 Tensile Yield (psi) MD 412 308 333 522 CD 327 312 245 356 Elongation at Break (%) MD 628 746 532 254 CD 746 745 679 403 Elongation at Yield (%) MD 42.9 37.9 32.4 137 CD 33.4 35.1 37.3 86 Modulus (N/mm.sup.2) MD 46.7 34.2 36.7 33.8 CD 37.8 32.8 26.5 26.2 Modulus (ksi) MD 6.8 5.0 5.3 4.9 CD 5.5 4.8 3.8 3.8

(53) The modulus data as shown in Table 2 indicate that Samples X3299, X3300, and X3301 have similar softness as the control laminate. The tensile strength data in machine direction (MD) and cross direction (CD) indicates that the control laminate has more anisotropicity. The elongation at break data indicates that Samples X3299, X3300, and X3301 are more ductile than the control laminate. Further, Samples X3299, X3300, and X3301 have good Elmendorf tear strength. Overall, the data indicates that Samples X3299, X3300, and X3301 have suitable mechanical properties for ostomy pouches.

(54) Samples X3299, X3300, and X3301 and the control laminate were tested according to ASTM E2611-09 (Standard Test Method for Measurement of Normal Incidence Sound Transmission of Acoustical Materials Based on the Transfer Matrix Method) using Bruel & Kjaer Sound Impedance Tube Kit-Type 4206T. In this test, a sound source (e.g. loudspeaker) is mounted at one end of an impedance tube, and the sample is placed in a holder in the tube at a distance away from the sound source. The loudspeaker generates broadband, stationary random sound waves that propagate as plane waves. The plane waves hit the sample with part of the waves reflected back into the source tube, part absorbed by the laminate sample, and part passing through the sample to a receiving tube. By measuring the sound pressure at four fixed locations (two in the source tube and two in the receiving tube) and calculating the complex transfer function using a four-channel digital frequency analyzer, the transmission loss of the laminate sample is determined.

(55) The sound tube transmission loss test data for laminate samples are plotted and shown in FIG. 5. Transmission loss expressed in decibel (dB) shows the degree of sound reduced or absorbed by the samples. The most audible range of human hearing is between about 1,000 Hz to 4,000 Hz. As shown in FIG. 5, Samples X3299, X3300, and X3301 have significantly better sound reduction/absorption properties than the control laminate. For example, Samples X3299 and X3300 provided more sound reduction than the control laminated by more than about 6 dB at around 3,500-4,000 Hz frequencies. In ostomy applications, an improvement in the sound transmission loss of about 6 dB represents a significant reduction of embarrassing flatus gas noise.

(56) In addition to the sound absorbing properties, the laminate samples were also evaluated for film noise properties. The film noise properties are different than the sound absorbing properties in that the sound absorbing properties are indicative of sample's ability for reducing flatus noise, whereas the film noise properties are indicative of a level of noise produced by the sample itself, for example, crackling noise made by the sample. The film noise of the laminate samples were measured and plotted in FIGS. 8 and 9. FIG. 8 is a graph of a-weighted sound pressure level, and FIG. 9 is a graph of mean overall sound pressure level of the laminate samples, the control sample and a commercial film for ostomy pouch. The commercial film, which was a multilayer film including a barrier layer comprising vinylidene chloride-methyl acrylate copolymer, had a thickness of 3 mil. As can be seen in FIGS. 8 and 9, Samples X3299, X3300, and X3301 have significantly lower sound pressure levels than the control laminate and the commercial film. Thus, in addition to providing superior sound absorbing properties, the laminate samples also make less noise than the control laminate and the commercial film. That is, ostomy pouches made using the laminate samples can reduce flatus gas noise better, and are also quieter than those made using the control laminate or the commercial film.

(57) Preferably, a composite film also includes at least one layer comprising a filler, such as talc, barium sulfate and/or mica, to further enhance sound absorbing properties. Two-layer laminate samples including a layer comprising barium sulfate or talc (Sample 302-2 and Sample 303-3) were prepared and evaluated for their sound absorbing properties. A two-layer control sample was also prepared. The compositions of the two-layer laminate samples and the control sample are summarized in Table 3.

(58) TABLE-US-00003 TABLE 3 Laminate Samples and Control Sample First Layer (1 mil) Second Layer (2 mil) Control 50.0 wt. % of Lotryl 20MA08 + 48.0 wt. % 60 wt. % Hybrar 5125 + 38 wt. % Vistamaxx 3980FL + 2.0 wt. % Polybatch Lotryl 20MA08 + 2 wt. % SAB-1982VA Polybatch SAB-1982VA Sample 302-2 20.0 wt. % of Lotryl 20MA08 + 48.0 wt. % 60 wt. % Hybrar 5125 + 38 wt. % Vistamaxx 3980FL + 30.0 wt. % Huberbrite Lotryl 20MA08 + 2 wt. % HB1 + 2.0 wt. % Polybatch SAB-1982VA Polybatch SAB-1982VA Sample 302-3 20.0 wt. % of Lotryl 20MA08 + 48.0 wt. % 60 wt. % Hybrar 5125 + 38 wt. % Vistamaxx 3980FL + 30.0 wt. % Luzenac Lotryl 20MA08 + 2 wt. % HAR T-84 + 2.0 wt. % Polybatch SAB-1982VA Polybatch SAB-1982VA

(59) Each of the samples (Sample 302-2 and Sample 303-3) and the control sample had a total thickness of about 3 mil, and included a first layer having a thickness of about 1 mil and a second layer having a thickness of 2 mil. The second layer of Sample 302-2. Sample 303-3, and the control sample was formed of the same film comprising about 60 wt. % of a non-hydrogenated vinyl-bond rich styrene-isoprene-styrene block copolymer (Hybrar 5125), about 38 wt. % of EMA (Lotryl 20MA08), and about 2 wt. % of slip and antiblock agent (Polybatch SAB-1982VA). The first layer of Sample 302-2 comprised about 20.0 wt. % of EMA (Lotryl 20MA08), about 48.0 wt. % of PP-elastomers (Vistamaxx 3980FL), about 30.0 wt. % barium sulfate (Huberbrite HB1 from Huber), and about 2.0 wt. % of slip and antiblock agent (Polybatch SAB-1982VA). The first layer of Sample 302-3 comprised about 20.0 wt. % of EMA (Lotryl 20MA08), about 48.0 wt. % of PP-elastomers (Vistamaxx 3980FL), about 30.0 wt. % talc (LuZenac HAR T-84 from Imerys), and about 2.0 wt. % of slip and antiblock agent (Polybatch SAB-1982VA). The first layer of the control sample comprised about 50.0 wt. % of EMA (Lotryl 20MA08), about 48.0 wt. % of PP-elastomers (Vistamaxx 3980FL), and about 2.0 wt. % of slip and antiblock agent (Polybatch SAB-1982VA).

(60) Multiple samples of Sample 302-2, Sample 303-3, and Control were tested according to ASTM E2611-09. The sound tube transmission loss test data for these samples are plotted and shown in FIGS. 10 and 11. The sound transmission loss expressed in decibel (dB) shows the degree of sound reduced or absorbed by the samples. FIG. 10 shows the sound transmission loss data of Sample 302-2 samples and the control samples. FIG. 11 shows the sound transmission loss data of Sample 302-3 samples and the control samples. As shown in FIGS. 10 and 11, Sample 302-2 including a second layer comprising about 30 wt. % barium sulfate and Sample 302-3 including a second layer comprising about 30 wt. % talc have higher sound transmission loss data than the control samples, which did not include any filler. Thus, a composite film including at least one layer comprising a filler, such as barium sulfate or talc, can provide better sound absorbing properties than those that do not include a filler.

(61) 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, where appropriate, include the singular. All of the concentrations noted herein as percentage are percent by weight unless otherwise noted.

(62) 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 invention. 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.