WO2007092289A2

WO2007092289A2 - Ostomy article including hot melt superabsorbent polymer composition and method of using the same

Info

Publication number: WO2007092289A2
Application number: PCT/US2007/002843
Authority: WO
Inventors: Sharf U. Ahmed; Eugene R. Simmons; Stephen G. Rippe; Charles W. Graves
Original assignee: HB Fuller Licensing and Financing Inc
Current assignee: HB Fuller Licensing and Financing Inc
Priority date: 2006-02-02
Filing date: 2007-02-02
Publication date: 2007-08-16
Anticipated expiration: 2008-08-02
Also published as: WO2007092289A3

Abstract

An ostomy appliance (10) that includes an ostomy pouch (11) and an ostomy article (20) operably coupled to the ostomy pouch. The ostomy article includes a first surface, a second surface (22) opposite the first surface, the second surface for contacting the skin of a user, a liquid permeable layer (41) and a hot melt superabsorbent polymer composition (21) that includes superabsorbent polymer particles (25) and thermoplastic polymer.

Description

OSTOMY ARTICLE INCLUDING HOT MELT SUPERABS ORBENT POLYMER

COMPOSITION AND METHOD OF USING THE SAME CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Serial No. 60/765,342 filed on February 2, 2006, entitled, "Ostomy Article Including Hot Melt Superabsorbent Polymer Composition," and incorporated herein.

BACKGROUND This invention relates to absorbing exudates from the body and in particular stomas and the surface of the skin surrounding a stoma.

Procedures such as colostomy, ileostomy, tracheotomy, urostomy, and other similar surgeries, leave a patient with an artificial orifice or opening. Often bodily material emerges from such openings and is collected in a ostomy bag, which is usually adhered to the skin by means of an adhesive plate or pad having an inlet for accommodating a stoma extending from the patient.

The ostomy bag, which is also referred to as a pouch, and the adhesive plate or pad make up the ostomy appliance. Ostomy appliances may be one-piece or two-piece appliances. When using a one-piece ostomy appliance, the ostomy plate or pad and the ostomy pouch are both removed and replaced when the pouch is full or the appliance requires changing. Frequently, however, the ostomy pouch component of the appliance is drainable and reusable. Therefore, two-piece ostomy appliances have been developed that provide for the removal and replacement of the ostomy plate or pad while allowing the ostomy pouch to be reused. At times, the ostomy plate or pad is left on the skin of the user for several days, and only the ostomy pouch is replaced.

Moisture in the form of perspiration tends to build up under the surface of the ostomy plate or pad because it typically is in intimate contact with the skin and is not breathable. This accumulation of moisture is undesirable because the area around the opening should remain dry. SUMMARY

In one aspect, the invention features an ostomy appliance that includes an ostomy pouch and an ostomy article, oper ably coupled to the ostomy pouch. The ostomy article includes a first surface, a second surface opposite the first surface, the second surface for contacting the skin of a user, a liquid permeable layer, and a hot melt superabsorbent polymer composition that includes superabsorbent polymer particles and thermoplastic polymer. In one embodiment, the ostomy article includes a second pressure sensitive adhesive composition disposed on the first surface of the ostomy article and in contact with the ostomy pouch. In another embodiment, the ostomy article includes a first pressure sensitive adhesive composition disposed on the second, i.e., skin contacting surface, of the ostomy article.

In other embodiments, the ostomy article further includes a release liner disposed on the pressure sensitive adhesive composition. In some embodiments, the ostomy article further includes a liquid permeable, superabsorbent polymer particle impermeable barrier disposed between the liquid permeable layer and the hot melt superabsorbent polymer composition.

In other embodiments, the ostomy article further includes a nonwoven layer, the hot melt superabsorbent polymer composition being disposed between the liquid permeable layer and the nonwoven layer.

In another embodiment, the ostomy article further includes a liquid impermeable layer disposed between the hot melt superabsorbent polymer composition and the nonwoven layer. In one embodiment, the liquid impermeable layer exhibits a moisture vapor transmission rate of at least about 100 g/m²/day. In other embodiments, the liquid impermeable layer includes a one-way liquid permeable layer.

In some embodiments, the ostomy article defines an opening that extends from the liquid permeable layer through the hot melt superabsorbent polymer composition.

In other embodiments, the liquid permeable layer includes a liquid permeable fibrous media that includes fibers selected from the group consisting of synthetic polymers, natural polymers and combinations thereof. In some embodiments, the liquid permeable layer is hydrophilic.

In one embodiment, the hot melt superabsorbent polymer composition is a discontinuous layer.

In another aspect, the invention features a method of attaching an ostomy appliance to a mammal, the method including contacting the mammal with a first surface of an ostomy article that includes the first surface, a second surface opposite the first surface, a liquid permeable layer, and a hot melt superabsorbent polymer composition that includes superabsorbent polymer particles and thermoplastic polymer. In one embodiment, the method further includes attaching an ostomy pouch to the ostomy article. In another embodiment, the method further includes removably attaching an ostomy pouch to the ostomy article.

In other embodiments, the attaching occurs through a mechanical fastener, an adhesive composition or a combination thereof.

In some embodiments, the ostomy article further includes a liquid permeable, superabsorbent polymer particle impermeable barrier disposed between the liquid permeable layer and the hot melt superabsorbent polymer composition. In one embodiment, the ostomy article further includes a nonwoven layer, the hot melt superabsorbent polymer composition being disposed between the liquid permeable layer and the nonwoven layer. In another embodiment, the ostomy article defines an opening that extends from the liquid permeable layer and through the hot melt superabsorbent polymer composition.

In other embodiments, the ostomy article further includes a pressure sensitive adhesive disposed on the skin contacting surface of the ostomy article.

In other aspects, the invention features an ostomy article that includes a first surface for contacting the skin of a user, a second surface opposite the first surface, a liquid permeable layer, a hot melt superabsorbent polymer composition that includes superabsorbent polymer particles and thermoplastic polymer, and a pressure sensitive adhesive composition disposed on the skin contacting surface, the ostomy article defining an opening that extends from the liquid permeable layer through the hot melt superabsorbent polymer composition. In one embodiment, the article further includes a liquid permeable, superabsorbent polymer particle impermeable barrier disposed between the liquid permeable layer and the hot melt superabsorbent polymer composition. In other embodiments, the article further includes a nonwoven layer, the hot melt superabsorbent polymer composition being disposed between the liquid permeable layer and the nonwoven layer. In some embodiments, the article further includes a liquid impermeable layer disposed between the hot melt superabsorbent polymer composition and the nonwoven layer. In another embodiment, the opening is dimensioned to accommodate a stoma of a user.

In other embodiments, the second surface includes a pressure sensitive adhesive composition and is available for contact with an ostomy pouch. The present invention features ostomy articles that exhibit good absoiption, good bodily fluid containment, good flexibility and an ability to conform to the surface with which they are in contact.

Other features and advantages will be apparent from the following description of the preferred embodiments and from the claims. GLOSSARY

In reference to the invention, these terms have the meanings set forth below:

The term "tackifier" means a component that imparts tack to a composition.

The term "tack" means the property of a material that enables it to form a bond of measurable strength immediately on contact with another surface. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a proximal (i.e., body facing) side of an ostomy appliance according to one embodiment of the invention;

FIG. 2 is a plan view of the proximal side of an ostomy article according to one embodiment of the invention; FIG. 3 is a cross-sectional view of the ostomy article of FIG. 2, taken along view line A-A;

FIG. 4 is a cross-sectional view of an ostomy article according to another embodiment;

FIG. 5 is a cross-sectional view of an ostomy article according to another embodiment;

FIG. 6 is a cross-sectional view of an ostomy article according to another embodiment;

FIG. 7 is a cross-sectional view of an ostomy article according to another embodiment; FIG. 8 is a cross-sectional view of an ostomy article according to another embodiment; and FIG. 9 is a cross-sectional view of an ostomy article according to another embodiment.

DETAILED DESCRIPTION

Referring to FIG. 1, the ostomy appliance 10 includes an ostomy pouch 11 and an ostomy article 20 that includes a skin contacting layer 22 (i.e., a layer intended to be worn proximal to the skin) and a hot melt superabsorbent polymer composition 2L A pressure sensitive adhesive 24 extends along the perimeter of the skin contacting layer. Prior to use, the ostomy article can include a release liner (not shown) to protect the utility of the pressure sensitive adhesive 24. FIGS. 1-3 illustrate an ostomy article 20 that includes a skin contacting layer 22, a hot melt superabsorbent polymer composition 21, and a pressure sensitive adhesive 24 adhered along the perimeter of the proximal surface of the skin contacting layer 22. The hot melt superabsorbent polymer composition 21 includes superabsorbent polymer particles 25. An opening 26, which is defined by a wall 27 that extends from skin contacting layer 22 through the wall of the ostomy pouch and to the chamber of the ostomy pouch 11, is available to accommodate the stoma (e.g., tube) extending from the user.

In another embodiment, the ostomy article 40 includes a tissue layer 41 disposed between the skin contacting layer 22a and the hot melt superabsorbent polymer composition 21a, which includes superabsorbent polymer particles 25a, an opening 26a, which is defined by wall 27a that extends from the hot melt superabsorbent polymer composition 21a, through tissue layer 41 and through the skin contacting layer 22a, and a pressure sensitive adhesive composition 24a disposed on the skin contacting layer 22a, as illustrated in FIG. 4. The tissue layer preferably is a liquid permeable, superabsorbent polymer particle impermeable barrier layer. A liquid permeable, superabsorbent polymer particle impermeable barrier layer is preferably positioned relative to the hot melt superabsorbent polymer composition so as to prevent superabsorbent polymer particles from contacting the skin of a user when the ostomy article is in position on a body. The liquid permeable, superabsorbent polymer particle impermeable banner can provide a useful skin contacting layer. The ostomy article can optionally include a nonwoven layer on the ostomy pouch contacting surface. In FIG. 5, the ostomy article 50 includes a hot melt superabsorbent polymer composition 21b, which includes superabsorbent polymer particles 25b, disposed between a skin contacting layer 22b, a non woven layer 57, a pressure sensitive adhesive composition 24b disposed on the skin contacting layer 22b, and an opening 26b, which is defined by wall 27b that extends from nonwoven layer 57, through the hot melt superabsorbent polymer composition 21b and through the skin contacting layer 22b.

In another embodiment, the ostomy article 60 includes a tissue layer 41c disposed between the hot melt superabsorbent polymer composition 21c, which includes superabsorbent polymer particles 25c, and the skin contacting layer 22c, as shown in .FIG. 6. A pressure sensitive adhesive composition 24c is disposed on the skin contacting layer 22c. An opening 26c is defined by wall 27c that extends from nonwoven layer 57c, through the hot melt superabsorbent polymer composition 21c, through tissue layer 41c and through the skin contacting layer 22c.

In other embodiments, a liquid impermeable layer is disposed between the distal surface of the hot melt superabsorbent polymer composition and the distal nonwoven layer. In FIG. 7, the ostomy article 70 includes a liquid impermeable layer 71 disposed between the hot melt superabsorbent polymer composition 21d, which includes superabsorbent polymer particles 25d, and a distal nonwoven layer 57d and a pressure sensitive adhesive composition 24d disposed on the skin contacting layer 22d. An opening 26d is defined by wall 27d that extends from nonwoven layer 57d, through liquid impermeable layer 71, through the hot melt superabsorbent polymer composition 21d and through the skin contacting layer 22d.

The ostomy article 80 can optionally include a tissue layer 41e disposed between the proximal surface of the hot melt superabsorbent polymer composition 21e, which includes superabsorbent polymer particles 25e, and the proximal skin contacting layer 22e, as shown in FIG. 8. The ostomy article 80 also includes a pressure sensitive adhesive composition 24e disposed on the skin contacting layer 22e. An opening 26e is defined by wall 27e that extends from nonwoven layer 57e, through liquid impermeable layer 71e, through the hot melt superabsorbent polymer composition 21e, through tissue layer 41 e and through the skin contacting layer 22e. The ostomy article can optionally include a pressure sensitive adhesive in the form of a continuous or discontinuous layer on the exposed surface of the distal layer. In FIG. 9, the ostomy article 90 includes a skin contacting layer 22f, a hot melt superabsorbent polymer composition 21f that includes superabsorbent polymer particles 25f, a first pressure sensitive adhesive composition 24f disposed on the proximal surface of the skin contacting layer 22f, and a second pressure sensitive adhesive 91 disposed along the perimeter of the distal surface of the skin contacting layer 22f and encircling the hot melt superabsorbent polymer composition 21f. When moisture is absorbed by the hot melt superabsorbent polymer composition 21f, the moisture is contained within the border created by the seal between the pressure sensitive adhesive 91 and the surface to which it is adhered, e.g., a bag (not shown). A wall 27f defines an opening 26f that extends from the hot melt superabsorbent polymer composition 21f and through the skin contacting layer 22f.

The ostomy article can be of any size and preferably is of a size well suited to its intended application. An ostomy article used for a tracheotomy, for example, is often smaller in size relative to than an ostomy article used for a colostomy. While the ostomy article is illustrated as being generally square in shape it could exhibit a variety of shapes including, e.g., polygonal (e.g., rectangular, triangular, pentagonal, heptagonal, and hexagonal), round, oval and hemispherical.

For a two-piece ostomy appliance, the proximal side of the ostomy article is positioned over a stoma of the user such that the ostomy opening of the ostomy article is in alignment with the user's stoma. Once in position, the ostomy article can be secured with a suitable mechanical device including, e.g., an ostomy belt. Alternatively or in addition, where a pressure sensitive adhesive is present on the proximal surface of the ostomy article, the ostomy article can be secured to the user through the adhesive. The user applies pressure to the ostomy article in the area of the adhesive until a secure bond is formed with the user. The user can then attach the ostomy pouch to the distal side of the ostomy article using any suitable mechanism including, e.g., mechanical means (e.g., thread and groove, clips, snaps, and hook and loop structures), adhesive means (e.g., a pressure sensitive adhesives and contact adhesives), and combinations thereof. Alternatively, the user can attached the ostomy pouch to the distal side of the ostomy article, as described above, before the user positions the proximal side of the ostomy article over the user's stoma.

If the appliance is a one-piece ostomy appliance, the proximal side of the appliance is positioned over the stoma of the user such that the ostomy opening of the ostomy article is in alignment with the user's stoma. Once in position, the ostomy appliance can be secured with using a mechanical device, e.g., an ostomy belt. Alternatively or in addition, where a pressure sensitive adhesive is present on the proximal surface of the ostomy article, the ostomy article can be secured to the user through the adhesive. The user then applies pressure to the ostomy article in the area of the adhesive until a secure bond is formed.

HOT MELT SUPERAB SORBENT POLYMER COMPOSITION The hot melt superabsorbent polymer composition can be any suitable hot melt superabsorbent polymer composition that includes a blend of thermoplastic polymer and superabsorbent polymer particles including, e.g., a hot melt adhesive composition that includes superabsorbent polymer particles. The hot melt superabsorbent polymer composition can be tacky (e.g., a hot melt superabsorbent polymer pressure sensitive adhesive composition) or nontacky. In some embodiments, the superabsorbent particles are additionally present on the surface of the hot melt superabsorbent polymer composition. Useful thermoplastic polymers include, e.g., styrenic block copolymers, polyolefins (e.g., amorphous and crystalline polyolefins including homogeneous and substantially linear ethylene/alpha-olefin interpolymers), interpolymers and copolymers of ethylene including, e.g., ethylene-vinyl acetate, ethylene-vinyl acetate ethylene-acrylic acid, ethylene-methacrylic acid, ethylene-methyl acrylate, ethylene-ethyl acrylate and ethylene n-butyl acrylate and derivatives (e.g., incorporating at least two comonomers), polyacrylic acids, polymethacrylic acids, polyacrylates, polyvinyl acetates, polylactic acids, polylactides, caprolactone polymers, poly (hydroxy-butyrate/hydroxyvalerate), polyvinyl alcohols, polyesters, copolyesters (e.g., biodegradable copolyesters), poly(ethy!ene oxide)polyether amide, polyester ether block copolymers, polyvinyl pyrrolidone, polyvinyl pyrrolidone-vinyl acetate copolymer, polyetheroxazoline, polyvinyl ethers (e.g., polyvinyl methyl ether), polyamides, polyacrylamide, and combinations thereof. A wide variety of block copolymers are useful including, e.g., A-B-A triblock copolymers, A-B diblock copolymers, and (A-B)n radial block copolymers, and branched and grafted versions thereof, wherein the A blocks are non-elastomeric polymer blocks , typically comprising polystyrene, and the B blocks are unsaturated conjugated diene or hydrogenated version thereof. Suitable B blocks include, e.g., isoprene, butadiene, ethylene/butylene (hydrogenated butadiene), ethylene/propylene (hydrogenated isoprene), and combinations thereof. Useful block copolymers are commercially available under the KRATON D and G series of trade designations from Shell Chemical Company (Houston, Texas), EUROPRENE Sol T trade designation from EniChem (Houston, Texas), and Vector® series of trade designations from Exxon (Dexco) (Houston, Texas).

Useful commercially available polyolefins include, e.g., AFFINITY substantially linear ethylene polymers polyolefin plastomers from The Dow Chemical Company

(Midland, Michigan) and EXACT homogeneous linear ethylene polymers from Exxon Chemical Company (Houston, Texas). Useful amorphous polyolefins and amorphous polyalphaolefins include homopolymers, copolymers, and terpolymers Of C₂-C₈ alphaolefins. Useful commercially available amorphous polyalphaolefins include, e.g., REXTAC and REXFLEX propylene based homopolymers, ethylene-propylene copolymers and butene-propylene copolymers available from Rexene (Dallas, Texas), VESTOPLAST alpha-olefin copolymers available from HuIs (Piscataway, New Jersey).

Any suitable superabsorbent polymer can be included in the composition. Superabsorbent polymers are also referred to as water-insoluble absorbent hydrogel- forming polymers, "hydrogel-forming" polymers, and "hydrocolloids." Superabsorbent polymers are able to absorb many times their own weight in water. Useful superabsorbent polymers include at least partially crosslinked, at least partially neutralized polymers that gel when contacted with water and are preferably substantially water insoluble. Suitable superabsorbent polymers include, e.g., polysaccharides (e.g., carboxymethyl starch, carboxymethyl cellulose, and hydroxypropyl cellulose), polyvinyl alcohol, polyvinyl ethers, polyvinyl pyridine, polyvinyl morpholinione, N,N-dimethylaminoethyl, N₁N- diethylaminopropyl, acrylates, methacrylates, and the quaternary salts thereof. The superabsorbent polymer preferably includes a plurality of functional groups, e.g., sulfonic acid groups, carboxy groups and combinations thereof. Suitable superabsorbent polymers are prepared from polymerizable, unsaturated, acid-containing monomers including, e.g., olefinically unsaturated acids and anhydrides having at least one carbon-carbon olefinic double bond including, e.g., olefinically unsaturated carboxylic acids and acid anhydrides, olefinically unsaturated sulfonic acids and combinations thereof. Useful olefinically unsaturated carboxylic acid and carboxylic acid anhydride monomers include, e.g., acrylic acid, methacrylic acid, ethacrylic acid, chloroacrylic acid, cyanoacrylic acid, crotonic acid, phenylacrylic acid, acrytoxy propionic acid, sorbic acid, chlorosorbic acid, angelic acid, cinnamic acid, p-chlorocinnamic acid, stearylacrylic acid, itaconic acid, citraconic acid, mesaconic acid, glutaconic acid, aconitic acid, maleic acid, fumaric acid, tricarboxyethylene acid anhydride, maleic acid anhydride, and combinations thereof. Useful olefinically unsaturated sulfonic acid monomers include aliphatic and aromatic vinyl sulfonic acids (e.g., vinyisulfonic acid, allyl sulfonic acid, vinyl toluene sulfonic acid and styrene sulfonic acid), acrylic and methacrylic sulfonic acids (e.g., sulfoethyl acrylate, sulfoethyl methacrylate, sulfopropyl acrylate, sulfopropyl methacrylate, 2-hydroxy-3-methacryloxypropyl sulfonic acid and 2-acrylamide-2- methyl propane sulfonic acid), and combinations thereof.

Useful superabsorbent polymers that include carboxy groups include, e.g., hydrolyzed starch-acrylonitrile graft copolymers, partially neutralized hydrolyzed starch- acrylonitrile graft copolymers, starch-acrylic acid graft copolymers, partially neutralized starch-acrylic acid graft copolymers, saponified vinyl acetate-acrylic ester copolymers, hydrolyzed acrylonitrile or acrylamide copolymers, slightly network crosslinked polymers of any of the foregoing copolymers, partially neutralized polyacrylic acid, and slightly network crosslinked polymers of partially neutralized polyacrylic acid. These polymers are disclosed, e.g., in U.S. Patent Nos. 4,076,663, 4,093,776, 4,666,983 and 4,734,478 and incorporated herein. The absorbent gelling particles can have any suitable property including, e.g., size, shape, morphology and combinations thereof. The superabsorbent particles preferably are spherical or substantially spherical and preferably have an average particle size no greater than about 400 μm, no greater than about 350 μm, no greater than about 200 μm, no greater than about 150 μm, no greater than about 100 μm, no greater than about 100 μm, no greater than about 50 μm, no greater than about 40 μm, at least about 10 μm, at least about 20 μm, or even about 20 μm to about 30 μm. Useful commercially available superabsorbent particles include, e.g., sodium polyacrylate superabsorbent particles available under the AQUA KEEP series of trade designations including, e.g., particles having a median particle size of from about 20 μm to about 30 μm available under the trade designation AQUA KEEP 10SH-NF, particles having an average particle size of from 200 μm to 300 μm available under the trade designation AQUA KEEP 10SH-P, particles having an average particle size of from 320 μm to 370 μm available under the trade designation AQUA KEEP SA60S, particles having an average particle size of from 350μm to 390 μm available under the trade designations AQUA KEEP SA60SX, SA55SX II and SA 60SL II, and particles having an average particle size of from 250 μm to 350 μm available under the trade designation AQUA KEEP SA60N TYPE II from Sumitomo Seika Chemicals Col, Ltd. (Japan). Useful superabsorbent polymer forms include, e.g., particles, granules, flakes, pulveruients, interparticle aggregates, interparticle crossHnked aggregates, fibers, foams, and combinations thereof. The hot melt superabsorbent polymer composition preferably includes superabsorbent polymer particles in an amount of at least about 30 % by weight, at least about 40 % by weight, at least about 50 % by weight, no greater than about 70 % by weight, or even no greater than about 60 % by weight.

The hot melt superabsorbent polymer composition can also include other additives including, e.g., plasticizers, tackifiers, waxes, antioxidants, biocides, chitosan, antimicrobial agents, zeolites, carbon black, pigments, fillers (e.g., titanium dioxide and hydrophilic fillers), surfactants, phosphites (e.g., IRGAFOS 168), antiblock additives, and combinations thereof.

Useful plasticizers include phthalate plasticizers (e.g., dioctyl phthalate and butyl benzyl phthalate (e.g., Santicizer 160 from Monsanto)), liquid polyesters (e.g., Dynacol 720 from HuIs, liquid polymeric plasticizer an example of which is commercially available from C. P. Hall, benzoate plasticizers (e.g., 1,4-cyclohexane dimethanol dibenzoate (e.g., BENZOFLEZ 352 commercially available from Velsicol), diethylene glycol/dipropylene glycol dibenzoate (e.g., BENZOFLEZ 50 commercially available from Velsicol), and diethylene glycol dibenzoate (e.g., commercially available 2-45 High Hydroxyl (Velsicol)), phosphite plasticizers (e.g., t-butyl diphenyl phosphate (e.g., SANTICIZER 154 from Monsanto)), liquid rosin derivatives having Ring and Ball softening points below about 60⁰C including, e.g., methyl esters of hydrogenated rosin (e.g., Hcrcoyn D from Hercules), vegetable oils, and animal oils (e.g., glycerol esters of fatty acids and polymerizable products thereof, citric acid esters (e.g., citric acid esters commercially available under the CITROFLEX series of trade designations), and toluene sulfonamide.

Useful water soluble or water dispersible plasticizers include polyethylene glycol having a molecular weight less than about 2000, derivatives of polyethylene glycol including Pycal 94, the phenyl ether of PEG available from ICI; ethoxylated bis phenol A (e.g., Macol 206 EM from PPG Industries) and dionyl phenol ethyloxylates (e.g., Surfonic DNP from Huntsman Chemical Corp.).

Other useful plasticizers include hydrocarbon oils (paraffinic oils, naphthenic oils and oils having low aromatic content), polybutene, liquid tackifying resins and liquid elastomers. Plasticizer oils are preferably low in volatility, transparent and have as little color and odor as possible.

Useful waxes include 12-hydroxystearamide, N-(2-hydroxy ethyl 12-hydroxy stearamide (Paricin 220 and 285 from CasChem), stearamide (Kemamide S from Witco), glycerin monostearate, sorbitan monostearate, and 12-hydroxy stearic acid. Other useful waxes include paraffin waxes, microcrystalline waxes, Fischer-Tropsch, polyethylene and by-products of polyethylene. Also useful in combination with the above waxes are waxes such as N,N'-ethylene-bis stearamide (Kemamide W-40 from Witco), hydrogenated castor oil (castor wax), oxidized synthetic waxes, and functionalized waxes such as oxidized polyethylene waxes (Petrolite E-JL 040).

Waxes are usefully employed to reduce viscosity as well as increase the blocking resistance at concentrations ranging from about 2 % by weight to about 25 % by weight, or even from about 10 % by weight to about 20 % by weight.

Useful tackifying agents include, e.g., resins derived from renewable resources such as rosin derivatives including wood rosin, tall oil and gum rosin, as well as rosin esters, natural and synthetic terpenes and derivatives thereof, aliphatic, aromatic and mixed aliphatic-aromatic petroleum based tackifiers. Examples of useful hydrocarbon resins include alpha-methyl styrene resins, branched and unbranched C₅-C10 resins and styrenic and hydrogenated modifications thereof. Useful tackifying resins range from being a liquid at 37°C to having a ring and ball softening point of about 135°C. The composition can include tackifying resin in an amount from 0 % by weight to about 50 % by weight, from about 5 % by weight to about 40 % by weight, or even from about 10 % by weight to about 20 % by weight.

Useful antioxidants include, e.g., hindered phenolics (e.g., IRGANOX 1010, IRGANOX 1076).

Hydrophilic fillers are a preferred class of additives, which are useful to alter the surface properties and/or increase the rate of absorption. Hydrophilic fillers include calcium carbonate, hydroxyethyl cellulose, hydroxypropyl cellulose, starch and cellulose esters (e.g., acetates), attagel clay, guargum, bentonite, hectorite, diatomaceous earth, talc, and combinations thereof.

Suitable surfactants include nonionic, anionic, and silicone surfactants. The composition can include surfactant in an amount from 0 % by weight to about 25 % by weight, or even from about 5 % by weight to about 15 % by weight.

Useful antimicrobial agents can be dissolved or suspended in the thermoplastic polymer of the composition. The antimicrobial agent can be mixed into a hot melt superabsorbeπt polymer composition, applied to the surface thereof, and combinations thereof. The antimicrobial also can be introduced into the composition by adding the antimicrobial in a powder form or adding antimicrobial agent carried on a powder support to the composition. Any suitable antimicrobial agent can be used including, e.g., sulfadiazine, silver ions, silver sulfadiazine, benzalkonium chloride, cetalkonium chloride, methylbenzethonium, neomycin sulfate, hexachlorophene, eosin, penicillin G, cephalothin, cephaloridine, tetracycline, linkomycin, nystatin, kanamycin, penicillinase-resistant penicillins, fradiomycin sulfate, camphor, and combinations thereof. In other methods, the antimicrobial agent is added to an aqueous solution, which is then applied to the surface of the hot melt superabsorbent polymer composition. The amount of antimicrobial agent should be sufficient to provide an effective antimicrobial concentration or dose rate of the material to the skin surface. Typical concentrations of standard antimicrobials range from about 0.01 % by weight to 5 % by weight based on the weight of the composition. Useful hot melt superabsorbent polymer compositions are described in, e.g., U.S. Patent Nos. 6,534,572, and 6,458,877, and U.S. Patent Application Serial Nos. 10/050,375 (published as U.S. Publication No. 2003/0134552), and 11/007,470, and incorporated herein. Useful hot melt superabsorbent polymer compositions are commercially available under the HYDROLOCK series of trade designations from H.B. Fuller Company (Vadnais Heights, Minnesota).

The hot melt superabsorbent polymer composition can be provided in a variety of forms including, e.g., a coating (e.g., a continuous or discontinuous coating), a film (e.g., a continuous or discontinuous film), a spray pattern, a mass, and combinations thereof, using any suitable technique including, e.g., contact coating, noncontact coating, spraying (e.g., spiral spraying and random spraying), extrusion (e.g., single screw extrusion and twin screw extrusion), slot coating, melt blown, foaming, engraved roller, gravure, screen printing, flexographic and compositions thereof.

The configuration, location and amount of the hot melt superabsorbent polymer composition present in the ostomy article is selected to optimize the absorbent properties of the ostomy article including, e.g., penetration time, penetration rate, wet back, absorbent capacity, fluid retention, and combinations thereof. The hot melt superabsorbent polymer composition can be present in the ostomy article in a variety of configurations including, e.g., random, pattern, stripes, dots having a variety of shapes (e.g., round, oval, square, diamond, and triangle), wavy lines, spiral spray, fanciful forms (e.g., leaves, flowers, and petals), and combinations thereof. The hot melt superabsorbent polymer composition is preferably in the form of a discontinuous layer.

One useful configuration includes a number of stripes of hot melt superabsorbent polymer composition, which can exist in a variety of configurations including, e.g., single or multiple stripes (e.g., one, two, three, four, and five), and continuous or discontinuous stripes. Where multiple stripes of hot melt superabsorbent polymer are present any suitable spacing between the individual regions can exist including, e.g., constant (e.g., equal spacing distances) or variable spacing distances. The stripes can also be positioned in any orientation including, e.g., along the length of the article, the width of the article, at any angle to the longitudinal axis of the article, at any angle to the latitudinal axis of the article, and combinations thereof. The width and length of the stripes can also be constant or variable. The spacing between the regions of hot melt superabsorbent polymer composition is preferably sufficient to allow the superabsorbent polymer freedom to expand as it would when contacted with water.

The configuration can also be selected to optimize leakage control, e.g., to prevent exudates from extending beyond a certain location.

Any amount of hot melt superabsorbent polymer composition can be present in the article. Preferably the ostomy article includes hot melt superabsorbent polymer composition in an amount of at least about 10 grams per square meter (g/m²), at least about 20 g/m², at least about 50 g/m², at least about 100 g/m², at least about 150 g/m², at least about 250 g/m², at least about 500 g/m², or even from about 50 g/m² to about 500 g/m².

SKIN CONTACTING LAYER

The skin contacting layer is a layer that is available for contact with the skin of a user. The skin contacting layer is exposed or can be exposed upon the removal of a release liner, where present. Useful skin contacting layers include, e.g., liquid permeable layers and liquid permeable, superabsorbent polymer particle impermeable barrier layers, and combinations thereof. A useful skin contacting layer is a liquid permeable fibrous media that includes fibers, which can be made from a variety of polymers including, e.g., synthetic polymers, natural polymers and combinations thereof. Suitable synthetic polymers include, e.g., polyolefins (e.g., polyethylene and polypropylene), polyesters, polyacrylates, ethylene vinyl acetate, and copolymers and blends thereof, biodegradable polymers (e.g., biodegradable polyester), and combinations thereof. Suitable natural polymers include cellulose (e.g., cotton and wood pulp fibers), and treated natural fibers including, e.g., treated cellulose fibers (e.g., cellulose acetate), and combinations thereof. The skin contacting layer can be in a variety of forms including, e.g., woven webs, nonwoven webs, knits, and combinations thereof. Useful methods of making nonwoven webs include, e.g., air laid, wet laid, meltblown, spunbonded, carded, thermally bonded, air-through bonded, powder bonded, latex bonded, solvent bonded, spunlaced, and combinations thereof.

The skin contacting layer can optionally be in the form of an apertured formed film. Apertured formed films are pervious to exudates and, if properly apertured, have a reduced tendency to allow liquids to pass back through and recontact the user's skin. Thus, the surface of the formed film that is in contact with the body remains dry. Suitable formed films are described in, e.g., U.S. Patent Nos. 3,929,135, 4,324,246, 4,342,314, 4,463,045, 4,637,819, 4,780,352, 5,006,394, and 6,180,052 and incorporated herein. A variety of aperlured formed films suitable for skin contacting sheets are commercially available from Ahlstrom (Windsor Lock, Connecticut) and First Quality Nonwoven (Greatneck, New York) and under the SOFTSKIN trade designation from BBA Nonwovens (Nashville, Tennessee). The skin contacting layer can optionally be made from a non-stick media. Nonstick media include apertured films that are liquid permeable and can be made from a variety of polymers including, e.g., polyurethane, polyethylene, polypropylene, polyamide, polyester polypropylene, polyethylene, polyether-amide, chlorinated polyethylene, styrene/butadiene block copolymers and polyvinyl chloride. The non-stick media may be in the form of moisture vapor permeable films, apertured films, woven-, non-woven and knit webs, and scrims.

The skin contacting surface of the skin contacting layer is preferably hydrophilic to allow liquids to transfer more readily there through, which improves the ability of the exudates to flow into and be absorbed by the absorbent components. The skin contacting surface of the skin contacting layer optionally can be made hydrophilic by treatment with a surfactant. Suitable methods of treating a sheet with a surfactant are described in, e.g., U.S. Patent No. 4,950,254 and incorporated herein. Alternately, surfactant can be incorporated into the polymer of the skin contacting layer as described in, e.g., in PCT Publication No. WO93/09741 and incorporated herein. Useful skin contacting layers can have any suitable thickness including at least about 12 microns (μm), at least about 25 μm, at least about 100 μm, at least about 150 μm, or even no greater than about 200 μm. In the case where the skin contacting layer is a nonwoven, useful nonwovens have a basis weight of from 10 g/m² to 200 g/m².

LIQUID PERMEABLE, SUPERAB S ORBENT POLYMER PARTICLE IMPERMEABLE BARRIER Useful liquid permeable, superabsorbent particle impermeable barriers include tissues, nonwoven webs, woven webs, apertured films or sheets, and combinations thereof. Preferably the liquid permeable, superabsorbent particle impermeable barrier is a tissue, e.g., a sheet that includes fibers, suitable examples of which include cellulose fibers, creped cellulose, comminuted wood pulp, modified crosslinked cellulose fibers, cotton (e.g., woven cotton), and combinations thereof. Useful commercially available tissues include those tissues available under the 1-PL YTISSUE series of trade designations from CityForest Corp. (Ladysmith, Wisconsin).

The woven and nonwoven webs can be made from a variety of fibers including natural fibers (e.g., cellulose fibers (e.g., cotton fibers and wood pulp fibers), creped cellulose fibers, comminuted wood pulp fibers, modified crosslinked cellulose fibers, and combinations thereof), and synthetic fibers made from a variety of polymers including, polyolefins (e.g., polyethylene and polypropylene), styrene, polyethylene terephthalate, ethylene-vinyl acetate, ethylene-vinyl acetate ethylene-acrylic acid, ethylene-methacrylic acid, ethylene-methyl acrylate, ethylene-ethyl acrylate and ethylene n-butyl acrylate and derivatives thereof (e.g., incorporating at least two comonomers), polyacrylic acids, polymethacrylic acids, polyacrylates, polyvinyl acetates, polylactic acids, polylactides, caprolactone polymers, poly (hydroxy-butyrate/hydroxyvalerate), polyesters, copolyesters (e.g., biodegradable copolyesters), poly(ethylene oxide)polyether amide, polyester ether block copolymers, polyvinyl pyrrolidone, polyvinyl pyrrolidone-vinyl acetate copolymer, polyetheroxazoline, polyvinyl ethers (e.g., polyvinyl methyl ether), polyamides, polyacrylamide, and combinations thereof, and combinations thereof, and combinations thereof.

The liquid permeable superabsorbent particle barrier can be prepared using any suitable method including, air laid, wet laid, meltblown, spunbonded, carded, spunlaced, and combinations thereof. Preferred tissues include wet laid tissues.

Apertured films can also be formed from the above-described polymers and formed into an apertured film using any suitable technique including those methods described in, e.g., U.S. Patent 5,980,814, 5,916,462, and 5,824,352 and incorporated herein.

The liquid permeable superabsorbent particle barrier can also include multiple layers. Any suitable method can be used to join the various layers of the liquid permeable superabsorbent particle barrier together including, e.g., thermal bonding, air-through bonding, powder bonding, latex bonding, solvent bonding, knurling, punching and embossing, and combinations thereof. Where the liquid permeable, superabsorbent particle impermeable barrier media is sufficiently durable, the liquid permeable, superabsorbent particle impermeable barrier can function as both the skin contacting layer and the liquid permeable, superabsorbent particle impermeable barrier, thereby eliminating the need for an additional skin contacting layer. The liquid permeable, superabsorbent particle impermeable barrier preferably exhibits a caliper thickness of no greater than about 500 μm, no greater than about 400 μm, at least 50 μm, at least 75 μm, or even from about 25 μm to about 500 μm.

LIQUID IMPERNEABLE LAYER The liquid impermeable layer prevents exudates and liquids absorbed by the ostomy article from escaping from the ostomy article. The liquid impermeable layer is liquid impervious (e.g., impervious to water-based exudates including, e.g., blood, serum, water, mucous, and other exudates) and flexible. The liquid impermeable layer can also exhibit elastic or extensible properties such that it can stretch in at least one direction and is preferably biodegradable. Useful methods of making a layer extensible using a mechanical operation include, e.g., pleating, corrugating, ring rolling, and those methods disclosed, e.g., in U.S. Patent 5,518,801, the relevant portions of which are incorporated herein.

The liquid impermeable layer can be breathable or nonbreathable. The term "breathable" refers to the property of allowing vapors to transfer there through, while preventing the transfer of liquids including such liquids as blood, serum, mucous, water, and other exudates. Suitable breathable films include hydrophilic films including monolithic films. The breathability of a film is determined by its moisture vapor transmission rate. The liquid impermeable layer preferably exhibits a moisture vapor transmission rate of about 100 g/m²/day, at least about 500 g/m²/day, at least about 1000 g/m²/day or even at least about 2500 g/m²/day when measured according ASTM E96-95 Upright Cup Method entitled, "Standard Test Methods for Water Vapor Transmission of Materials," March 6, 1995.

Useful liquid impermeable layers include, e.g., polymeric films (e.g., thermoplastic films of polymers including e.g., polyethylene, polypropylene, polyester and ethylene vinyl acetate), composites including, e.g., film-coated woven and nonwoven webs, foams (e.g., polyurethane foams including, e.g., breathable polyurethane foams), and combinations thereof.

Useful liquid impermeable composites (e.g., laminates) include a fibrous web (e.g., a woven or nonwoven web) and a continuous film bonded thereto. The fibrous web provides a soft touch to the exterior surface of the liquid impermeable layer and therefore the ostomy article. Examples of useful methods for preparing composites are described in U.S. Patent Nos. 6,583,332, 5,827,252, and 6,843,874 and incorporated herein.

In some embodiments, the liquid impermeable layer can include a one-way liquid permeable layer, i.e., a layer that allows liquid to pass from a first surface (e.g., an exterior surface) to a second surface (e.g., an interior surface), and inhibits or preferably prevents liquids from moving from the second surface to the first surface. Examples of useful oneway liquid permeable layers are described in U.S. Patent No. 6,228,462, and incorporated herein.

The liquid impermeable layer is preferably thin and conformable to the body. The liquid impermeable layer preferably has a thickness of from about 12 microns to about 200 μm, no greater than about 150 μm, no greater than about 100 μm, or even from about 12 μm to about 25 μm. Conformability is somewhat dependent on thickness, thus the thinner the film the more conformable the film.

Useful liquid impermeable materials can be made from polymers commercially available under the trade designation PEBAX from Arkema, Inc. (Pittsburgh, PA) and HYTREL from E. I. Du Pont de Nemours and Company (Wilmington, Delaware).

SKIN ATTACHMENT PRESSURE SENSITIVE ADHESIVE

Useful pressure sensitive adhesives that are suitable for application to the skin include pressure sensitive adhesive compositions in which the base polymer includes, e.g., block copolymer (e.g., styrene-isoprene-styrene, styrene-butadiene-styrene, styrene- ethylene-butylene-styrene, and styrene-ethylene-propylene-styrene), acrylic acid, acrylate, silicone, polyurethane, polyurethane elastomers, polyester, polyester elastomers (e.g., aliphatic-aromatic copolyesters, copolyester-copolyether and copolyether-copolyamide), polylactic acid, polyoxyalkanoates, and combinations thereof. Useful adhesives for skin attachment include those adhesives described, e.g., in

U.S. Patent No. 4,917,697, U.S. Patent Application Serial No. 10/934,266 filed August 1, 2002, and U.S. Patent Application Serial No. 10/211,162 filed September 3, 2004 and incorporated herein. Suitable commercially available skin attachment adhesives are available, e.g., under the trade designations LUNATAC D-1053, HL 2711 and HL 2539 from H.B. Fuller Co. (St. Paul, Minnesota). A useful commercially available styrene- isoprene-styrene skin attachment adhesive is available under the trade designation HM 1902 from H.B. Fuller Company (St. Paul, MN).

Other useful skin attachment adhesives are described, e.g., in U.S. Patent Nos. 5,614,310, 6,171,985, and 6,198,016, and PCT Publication Nos. WO 99/13866 and WO 99/13865.

The skin attachment adhesive can optionally include medicaments useful for enhancing healing and antimicrobial agents (e.g., iodine) to prevent infection.

RELEASE LINER The ostomy article can optionally include a release liner to protect the utility of the pressure sensitive adhesive prior to use and for ease of handling. Where present, the release liner is removed prior to using the ostomy article. Any suitable release liner can be used including, e.g., liners made of or coated with polyethylene, polypropylene and fluorocarbons, and silicone coated release papers and polyester films. Useful commercially available release liners include, e.g., silicone coated release papers available under the POLYSLIK trade designations including POLYSLIK S-8004 83 pound bleached silicone release paper from H. P. Smith Co. (Chicago, 111.) and 2-80-BKG-157 80 pound bleached two-sided silicone coated paper from Daubert Chemical Co., (Dixon, III.).

The components of the ostomy article can be joined together using any suitable mechanism including, e.g., adhesive bonding, stitching, heat bonding, pressure bonding, dynamic mechanical bonding, ultrasonic bonding, simultaneously or sequentially extruding at least two components of the ostomy article, and combinations thereof. Methods of attaching components of a ostomy article to each other are well known to the skilled artisan.

CONSTRUCTION ADHESIVE

Where present, the construction adhesive can be any adhesive suitable for maintaining at least two of the components of the ostomy article in fixed relation to each other. The construction adhesive can be applied to the periphery of a layer, the major surface of the layer, the perimeter of the ostomy article and combinations thereof. When applied to the perimeter or periphery, the construction adhesive can be in the form of a continuous or discontinuous coating. When applied to a major surface of the layer, the construction adhesive is provided as a discontinuous coating. The construction adhesive can be applied as a discontinuous coating using any suitable method that produces any suitable discontinuous coating including, e.g., a spiral spray, random spray, gravure, dot and random fibridization. Useful construction adhesives include, e.g., hot melt adhesives, pressure sensitive adhesives, hot melt pressure sensitive adhesives, and blends thereof. One example of a suitable commercially available construction adhesive is HL-1713 styrene-isoprene-styrene based construction adhesive from H.B. Fuller Company (St. Paul, Minnesota). The components can be joined together in any suitable manner including, e.g., joining such that each component is directly secured to another component, a component is secured to an intermediate component, a component is integral with another component, and combinations thereof.

The ostomy article can exhibit a variety of shapes and the ostomy article in its entirety or any component thereof can have any combination of height, width and depth. All references disclosed herein are incorporated herein by reference Other embodiments are within the claims. Although the article has been described as including a hot melt superabsorbent polymer composition comprising a blend of thermoplastic polymer and superabsorbent polymer particles, in other embodiments the article can alternatively or in addition include a thermoplastic composition and superabsorbent polymer particles disposed on at least one surface of the thermoplastic composition and optionally extending into the thermoplastic composition from the surface. What is claimed is:

Claims

1. An ostomy appliance comprising: an ostomy pouch; and an ostomy article operably coupled to said ostomy pouch, said ostomy article comprising a first surface, a second surface opposite said first surface, said second surface for contacting the skin of a user, a liquid permeable layer, and a hot melt superabsorbent polymer composition comprising superabsorbent polymer particles and thermoplastic polymer.

2. The ostomy appliance of claim 1 , wherein said ostomy article further comprises a pressure sensitive adhesive composition disposed on the second surface of said ostomy article.

3. The ostomy appliance of claim 1, wherein said first surface comprises a pressure sensitive adhesive composition, said ostomy pouch being in contact with said pressure sensitive adhesive composition.

4. The ostomy appliance of claim 2, wherein said ostomy article further comprises a release liner disposed on said pressure sensitive adhesive composition.

5. The ostomy appliance of claim 1, wherein said ostomy article further comprises a liquid permeable, superabsorbent polymer particle impermeable barrier disposed between said liquid permeable layer and said hot melt superabsorbent polymer composition.

6. The ostomy appliance of claim 1, wherein said ostomy article further comprises a nonwoven layer, said hot melt superabsorbent polymer composition being disposed between said liquid permeable layer and said nonwoven layer.

7. The ostomy appliance of claim 6, wherein said ostomy article further comprises a liquid impermeable layer disposed between said hot melt superabsorbent polymer composition and said πonwoven layer.

8. The ostomy appliance of claim 7, wherein said liquid impermeable layer exhibits a moisture vapor transmission rate of at least about 100 g/m²/day.

9. The ostomy appliance of claim 6, wherein said liquid impermeable layer comprises a one-way liquid permeable layer.

10. The ostomy appliance of claim 1, wherein said ostomy article defines an opening that extends from said liquid permeable layer through said hot melt superabsorbent polymer composition.

1 1. The ostomy appliance of claim 1 , wherein said liquid permeable layer comprises a liquid permeable fibrous media comprising fibers selected from the group consisting of synthetic polymers, natural polymers and combinations thereof.

12. The ostomy appliance if claim 1, wherein said liquid permeable layer is hydrophilic.

13. The ostomy appliance of claim 1, wherein said hot melt superabsorbent polymer composition comprises a discontinuous layer.

14. A method of attaching an ostomy appliance to a mammal, said method comprising: contacting the mammal with a first surface of an ostomy article comprising said first surface, a second surface opposite the first surface, a liquid permeable layer, and a hot melt superabsorbent polymer composition comprising superabsoibent polymer particles and thermoplastic polymer.

15. The method of claim 14 further comprising attaching an ostomy pouch to said ostomy article.

16. The method of claim 14, further comprising removably attaching an ostomy pouch to said ostomy article.

17. The method of claim 14, wherein said attaching occurs through a mechanical fastener, an adhesive composition or a combination thereof.

18. The method of claim 14, wherein said ostomy article further comprises a liquid permeable, superabsorbent polymer particle impermeable banner disposed between said liquid permeable layer and said hot melt superabsorbent polymer composition.

19. The method of claim 14, wherein said ostomy article further comprises a nonwoven layer, said hot melt superabsorbent polymer composition being disposed between said liquid permeable layer and said nonwoven layer.

20. The method of claim 14, wherein said ostomy article defines an opening that extends from said liquid permeable layer and through said hot melt superabsorbent polymer composition.

21. The method of claim 14, wherein said ostomy article further comprises a pressure sensitive adhesive disposed on said first surface of said ostomy article.

22. An ostomy article comprising: a first surface for contacting the skin of a user; a second surface opposite the first surface; a liquid permeable layer; a hot melt superabsorbent polymer composition comprising superabsorbent polymer particles and thermoplastic polymer; and a pressure sensitive adhesive composition disposed on said first surface, said ostomy article defining an opening that extends from said liquid permeable layer through said hot melt superabsorbent polymer composition.

23. The ostomy article of claim 22 further comprising a liquid permeable, superabsorbent polymer particle impermeable barrier disposed between said liquid permeable layer and said hot melt superabsorbent polymer composition.

24. The ostomy article of claim 23 further comprising a nonwoven layer, said hot melt superabsorbent polymer composition being disposed between said liquid permeable layer and said nonwoven layer.

25. The ostomy article of claim 24 further comprising a liquid impermeable layer disposed between said hot melt superabsorbent polymer composition and said nonwoven layer.

26. The ostomy article of claim 22, wherein said opening is dimensioned to accommodate a stoma of a user.

27. The ostomy article of claim 22, wherein said second surface comprises a pressure sensitive adhesive composition and is available for contact with an ostomy pouch.