Patent Description:
An ostomy appliance is a medical device or prosthetic that provides a means for collecting waste from a stoma typically created as a result of a surgical procedure to divert a portion of the colon or small intestine. One type of ostomy appliance is a pouch that is attached to a user around the stoma or the peristomal area.

Typically, an ostomy wafer including a skin barrier, a backing layer and an inlet opening for receiving a stoma is used to secure an ostomy pouch to a user. The ostomy wafer may be attached to an ostomy pouch for a one-piece pouch system. Alternatively, the ostomy wafer may be configured as a faceplate for a two-piece pouch system including a body-side coupling that is configured to engage a pouch-side coupling attached to an ostomy pouch.

The skin barriers may remain adhered to a user's skin for extended periods to secure an ostomy pouch. Thus, the skin barriers should have sufficient adhesive strength, yet not be so aggressive as to risk skin injury or irritation during use and upon removal. Due to the extensive wear time, it is desirable that skin barriers include ingredients to minimize skin irritation and promote skin health.

A skin barrier including ceramide has been developed and available through the Applicant of the present application under the trade name, CeraPlus®. However, adding skin health ingredients, such as ceramide, into skin barriers can become costly, and may be limited due to possible interactions between skin healthy ingredients and skin barrier materials. Further, a large portion of skin friendly ingredients dispersed in the skin barrier matrix may not migrate to the skin contact surface. Thus, the present disclosure provides an improved skin barrier including skin friendly ingredients.

<CIT> discloses an ostomy appliance with inner and outer pouches separably joined together by peelable seams. A vent passage and deodorising filter are also provided, most advantageously located externally of the pouches, and a pre-filter is preferably positioned in advance of the deodorising filter.

<CIT> discloses a collecting device comprising a collecting pouch and an adhesive wafer for attachment to the body, said wafer comprising at least one low-modulus backing layer and an elastic adhesive gel layer comprising a polyalkyleneoxide polymer and an organosiloxane based cross-linked adhesive system.

<CIT> discloses that a blowout means that the excrement enters an area between its faceplate and the one's skin, externally leaking out. In case of blowout, a clothing and a bedding are wasted and people around the ostomate gets annoyed, causing serious problems in preventing people from an advance into society. This invention is intended to prevent the excrement leaked out from externally spreading out. Adhesion unit (<NUM>) is provided so that a caption hole (<NUM>) is arranged on the circumference of the faceplate (<NUM>). An auxiliary storage bag (<NUM>) is prepared to store the excrement leaking in case of blowout. The first opening (<NUM>) through the auxiliary storage bag is coupled to the adhesion unit. The second opening (<NUM>) through the auxiliary storage bag is coupled to the faceplate. The auxiliary storage bag envelops the caption hole. The excrement as a result of blowout leaking from the caption hole is captured in the auxiliary storage bag to prevent the spread-out.

<CIT> discloses a covering bag which comprises a front sheet, a right back sheet disposed from the upper right to the lower left and a left back sheet disposed in the opposite direction from the upper left to the lower right, both the back sheets being disposed to partially cover the back side of said front sheet, in order to form a bag, whereby the skin contact plate of an artificial anus outfit can be exposed outside from a nearly triangular opening formed at a portion above the intersection of the oblique fringes of the back sheets. The covering bag is provided with fasteners at the outer periphery of the opening thereof. A belt to be used with the covering bag is also provided with fasteners at the outer periphery of a through hole thereof for supporting the artificial anus outfit, the fasteners being disposed in correspondence with the above-mentioned fasteners provided on the covering bag. The covering bag can be supported at least in the longitudinal direction of the belt and in a direction perpendicular to the longitudinal direction of the belt as desired in accordance with the combination of the fasteners to be engaged with each other.

<CIT> discloses an adhesive element having an adhesive surface showing adhesive properties for adhering to a substrate wherein at least a part of the surface has been treated, resulting in alteration of the surface properties of the heat treated part of the surface. By heat treatment it is possible to provide an adhesive surface having parts showing different colour, water absorption properties, and/or adhesive properties.

The present disclosure provides an ostomy wafer as detailed in claim <NUM>, and a method according to claim <NUM>. Advantageous features are provided in dependent claims.

In one aspect, an ostomy appliance comprising at least one skin friendly ingredient is provided. The ostomy appliance may be formed from at least one skin barrier material or at least one stoma base sealing material. The at least one skin friendly ingredient may be provided only on a skin contact surface or only in a skin contact layer of the ostomy appliance.

In an embodiment, the ostomy appliance may be an ostomy wafer comprising a baking layer, a skin barrier, and an inlet opening for receiving a stoma. The skin barrier may be formed from at least one skin barrier material, and the backing layer may be laminated to a distal surface of the skin barrier. The at least one skin barrier material may be a hydrocolloid adhesive.

The at least one skin friendly ingredient may be provided only on a skin contact surface of the skin barrier. In some embodiments, the skin barrier may include a skin contact layer and an inner layer, wherein the at least one skin friendly ingredient may be dispersed in the skin contact layer. In such embodiments, a thickness of the skin contact layer may be less than a thickness of the inner layer.

In an embodiment, the ostomy wafer may be attached to a pouch for a one-piece ostomy pouch system. In another embodiment, the ostomy wafer may further include a body-side coupling ring configured to engage a pouch-side coupling ring attached to a pouch in a two-piece ostomy pouch system.

In another embodiment, the ostomy appliance may be a stoma ring formed from at least one stoma sealing material. The at least one stoma sealing material may comprise a hydrocolloid adhesive and/or a silicone adhesive. The at least one skin friendly ingredient may be provided only on outer surfaces of the stoma ring.

In an embodiment, the stoma ring may include a first outer layer, a second outer layer, and an inner layer therebetween, wherein the at least one skin friendly ingredient may be dispersed in the first and second outer layers.

In any of the foregoing embodiments, at least one skin friendly ingredient may be provided in a pattern. For example, the at least one skin friendly ingredient may be provided in a pattern of concentric circles. In an embodiment, the at least one skin friendly ingredient may be provided on the skin contact surface in a pattern having a thickness, wherein the at least one skin friendly ingredient may be injected into the at least one skin barrier material or at least one stoma sealing material proximate the skin contact surface.

In yet another aspect, a method of making an ostomy appliance is provided. The method may include the steps of forming the ostomy appliance from at least one skin barrier material or at least one stoma sealing material, and providing at least one skin friendly ingredient only on a skin contact surface or only in a skin contact layer.

In an embodiment, the step of providing at least one skin friendly ingredient may include providing the at least one skin friendly ingredient in a powder form and sprinkled the same on the skin contact surface of the ostomy appliance. In another embodiment, the step of providing at least one skin friendly ingredient may include dissolving the at least one skin friendly ingredient in a solvent or water and spraying the same on the skin contact surface of the ostomy appliance. In yet another embodiment, the step of providing at least one skin friendly ingredient may include injecting the least one skin friendly ingredient into the ostomy appliance proximate to the skin contact surface using a device comprising micro-needles.

In yet another embodiment, the ostomy appliance may be formed by pressing the at least one skin barrier material or at least one stoma sealing material on a release liner. In such an embodiment, the method may include a step of applying the at least one skin friendly ingredient on the release liner prior to the pressing step, such that when the skin barrier material is pressed and the release liner is removed, the at least one skin friendly ingredient transfers to the skin contact surface of the at least one skin barrier material or the at least one stoma sealing material. The pressing step may be performed during manufacturing of ostomy appliances. In another embodiment, a user may be instructed to carry out the pressing step before removing the release liner.

In an embodiment, the ostomy appliance may include a skin contact layer formed from a skin barrier material or a stoma sealing material and an inner layer formed from a skin barrier material or a stoma sealing material. The skin contact layer and the inner layer may be coextruded, wherein a skin barrier formulation or a stoma sealing formulation for the skin contact layer may contain the at least one skin friendly ingredient to form the skin contact layer comprising the at least one skin friendly ingredient dispersed therein.

In any of the foregoing embodiments, the at least one skin friendly ingredient may be selected from various materials that protect skin, reduce skin irritation, aid healing, and/or promote skin health, such as vitamin E, ceramide, cholesterol, fatty acids, micro-pockets of pH buffers, polysaccharides, and anti-wrinkle agents.

The method of providing at least one skin friendly ingredient only on a skin contact surface or only in a skin contact layer according to the foregoing embodiments may be used to make other skin contact products, such as wound care products.

Other aspects, objectives and advantages will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

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:.

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

Referring to <FIG>, an embodiment of an ostomy wafer <NUM> for an ostomy appliance is shown. The ostomy wafer <NUM> may generally include a skin barrier <NUM>, a backing layer <NUM>, a release liner <NUM>, and inlet opening <NUM> for receiving a stoma. As best shown in <FIG>, the skin barrier <NUM> may include skin friendly ingredients <NUM> provided only on a skin contact surface <NUM> of the skin barrier <NUM>.

The skin friendly ingredients may include materials that protect skin, reduce skin irritation, aid healing, and/or promote skin health, such as collagen boosters. Suitable skin friendly ingredients include, but are not limited to, vitamin E, vitamin A, vitamin C, aloe vera extract, ceramide, cholesterol, fatty acids, polysaccarides, such as Karaya, anti-wrinkle agents, anti- inflammatory/soothing agents, such as ginkgolide A, hydrolyzed collagen, alpha- amyrin, beta-amyrin, oleanolic acid, and antiperspirants, such as Alcloxa. In an embodiment, the skin friendly ingredients <NUM> may comprise fatty acids, which may function as antimicrobial agent, anti-viral agent, anti-inflammatory agent, and/or antifungal agent that can combat fungal infections prevalent in ostomates. For example, the skin friendly ingredients <NUM> may comprise fatty acids from coconut oil having antibacterial, antifungal and anti-inflammatory properties. In another embodiment, the skin friendly ingredients <NUM> may comprise anti-wrinkle agents to minimize skin crevices proximate a stoma base to provide a smooth surface to improve barrier adhesion. For example, the skin friendly ingredients may comprise rose oil having anti-wrinkle, antimicrobial, and anti-inflammatory properties. Yet in another embodiment, the skin friendly ingredients <NUM> may comprise micro-encapsulated pain relieving ingredients configured to release when exposed to stoma effluent. The skin friendly ingredients <NUM> may also comprise micro-pockets of pH buffers.

The skin friendly ingredients may be provided in various forms, for example, fine powder, liquid, or encapsulated, such as encapsulated skin health formulations available from Salvona, Hamilton, NJ. Some skin friendly ingredients may be dissolved in a solvent or water.

The skin barrier <NUM> may be formed from a suitable medical grade adhesive, such as various hydrocolloid adhesives comprising water absorbing hydrocolloid particles dispersed in skin friendly adhesive compositions. In an embodiment, the skin barrier <NUM> may be formed from an adhesive composition comprising viscoelastic adhesive elastomers, such as polyisobutylene and styrene block copolymer, tackifier, antioxidant, and hydrocolloids, such as sodium carboxymethylcellulose. An example of such hydrocolloid adhesive compositions is disclosed in <CIT>, which is assigned to Applicant of the present application. Other suitable skin barrier materials may include, but are not limited to, silicone based adhesives and acrylic adhesives.

In an embodiment, at least one skin friendly ingredient, such as particles of vitamin E encapsulated in gelatinous micro shell, may be sprinkled on a release liner <NUM>, which is subsequently laminated to the skin barrier <NUM>. The ostomy wafer <NUM> may be configured such that when the release liner <NUM> is removed prior to use, the skin friendly ingredients <NUM> transfer to the skin barrier <NUM> to provide the skin barrier <NUM> with the skin friendly ingredients <NUM> provided only on the skin contact surface <NUM> as shown in <FIG>. When compared to skin barriers including skin friendly ingredients dispersed throughout the entire skin barrier matrix, the ostomy wafer <NUM> requires significantly less skin friendly ingredients, which may provide a substantial cost reduction. Further, since the skin friendly ingredients are provided only on the skin contact surface of a skin barrier, almost all of the skin friendly ingredients may come in contact with user's skin to maximize benefits provided by the skin friendly ingredients.

In some manufacturing processes, the skin friendly ingredients may be applied on a release liner or film prior to a skin barrier cookie being pressed onto the release liner or film to allow the skin friendly ingredients to transfer to the skin barrier. The skin friendly ingredients may be sprinkled on the release liner or film in powder form, or may be dissolved in a solvent or water and sprayed on the release liner or film. In some embodiments, the skin friendly ingredients may be applied directly on the skin contact surface of a skin barrier. Further, the skin friendly ingredients may be formulated to provide additional functions, such as improving skin barrier adhesion and/or other skin barrier properties, such as erosion.

The backing layer <NUM> may be formed from a suitable material, such as a gas-permeable, water-resistant material. Preferably, the backing layer <NUM> is highly flexible, so that it will conform readily to body contours and body movements, and relatively strong and durable.

The ostomy wafer <NUM> may be attached to a pouch <NUM> for a one-piece ostomy pouch <NUM> as shown in <FIG>. Alternatively, the ostomy wafer <NUM> may be used to make a faceplate <NUM> including a body-side coupling ring <NUM> configured to engage a pouch-side coupling ring <NUM> for a two-piece ostomy pouch system as shown in <FIG>.

<FIG> is a cross-sectional illustration of an ostomy wafer <NUM> according to another embodiment. The ostomy wafer <NUM> may comprise a two-layer skin barrier <NUM>, a backing layer <NUM>, and an inlet opening <NUM> for receiving a stoma. The two-layer skin barrier <NUM> may include a first skin barrier layer <NUM> comprising skin friendly ingredients <NUM> and a second skin barrier layer <NUM>. The skin friendly ingredients <NUM> may be dispersed in the first skin barrier layer <NUM>. In an embodiment, the two-layer skin barrier <NUM> may be formed via a known coextrusion process, wherein the skin friendly ingredients are mixed with an adhesive formulation for the first skin barrier layer <NUM> and extruded. The first and second skin barrier layers <NUM>, <NUM> may be formed from the same or different adhesive formulations.

In some embodiments, the first skin barrier layer <NUM> is thinner than the second skin barrier layer <NUM>. For example, a thickness of the first skin barrier layer <NUM> may be less than about <NUM>% of a thickness of the second barrier layer <NUM>, preferably less than about <NUM>%, more preferably less than about <NUM>%.

<FIG> is a cross-sectional illustration of an ostomy wafer <NUM> according yet another embodiment. The wafer <NUM> may comprise a first adhesive <NUM>, a second adhesive <NUM>, a backing layer <NUM>, and an inlet opening <NUM> for receiving a stoma. The first adhesive <NUM> may include skin friendly ingredients <NUM> provided only on a skin contact surface <NUM>. The first adhesive <NUM> may be formed from a suitable pliable and tacky adhesive formulation capable of engaging and sealing the peristomal area, such as hydrophilic adhesives and skin barrier materials discussed in the foregoing embodiments. The second adhesive <NUM> may be formed from a hydrophilic adhesive or a hydrophobic adhesive, such as silicone adhesives or acrylic adhesives. The first and second adhesives <NUM>, <NUM> may be formed from a same adhesive formulation or different adhesive formulations. In an embodiment, the first adhesive <NUM> may include a first skin contact layer and a second layer, wherein skin friendly ingredients are dispersed in the first skin contact layer. In some embodiments, skin friendly ingredients may also be provided on a skin contact surface <NUM> of the second adhesive <NUM>.

In some embodiments, skin friendly ingredients may be provided on a portion of a skin contact surface. For example, skin friendly ingredients <NUM> may be provided in a pattern of concentric circles <NUM>, <NUM>, <NUM> on an ostomy skin barrier <NUM> as shown in <FIG>. Although the pattern of the skin friendly ingredients <NUM> of <FIG> includes three concentric circles, the pattern of the skin friendly ingredients may include one or two circles, or more than three circles in other embodiments. The skin friendly ingredients may also be provided in various different patterns on a skin contact surface of a skin barrier.

In an embodiment, a layer of skin barrier material comprising skin friendly ingredients incorporated therein may be formed in a desired pattern and laminated to a skin contact surface of an ostomy skin barrier. For example, a layer of skin barrier material, which may be formed from the same or a different skin adhesive than that of the ostomy skin barrier <NUM>, comprising skin friendly ingredients may be formed as concentric circles and laminated to the ostomy skin barrier <NUM> to form the pattern of concentric circles <NUM>, <NUM>, <NUM> as shown in <FIG>. In another embodiment, the skin friendly ingredients may be injected into an ostomy skin barrier proximate a skin contact surface in desired shapes, patterns and depths, for example, using micro-needles, to minimize any waste of skin friendly ingredients during manufacturing. For example, the skin friendly ingredients <NUM>, such as microencapsulated skin friendly ingredients, may be injected into the ostomy skin barrier <NUM> to form the pattern of concentric circles <NUM>, <NUM>, <NUM>. In an embodiment, a hydrophobic skin friendly adhesive may be provided to contour the outer periphery of the skin facing side of the ostomy skin barrier to minimize or prevent swelling and lifting of hydrocolloid adhesives and nonwoven fabric.

<FIG> illustrate a stoma ring <NUM> according to an embodiment. The stoma ring <NUM> may generally comprise a stoma sealing material <NUM> and skin friendly ingredients <NUM> provides on outer surfaces of the stoma ring <NUM>. The stoma sealing material <NUM> may be formed from a medical grade sealing material suitable for sealing around a stoma, such as hydrocolloid adhesives and silicone adhesives. The skin friendly ingredients <NUM> may be provided on at least a portion of the outer surfaces of the stoma ring <NUM> similar to the skin friendly ingredients <NUM>, <NUM>, <NUM>, <NUM> of the foregoing embodiments. In an embodiment, the stoma ring <NUM> may comprise two outer layers and an inner layer arranged therebewteen, wherein the outer layers comprise skin friendly ingredients incorporated therein.

Skin friendly ingredients may be provided on or incorporated into at least portion of an ostomy skin barrier or a stoma ring to maximize benefits to user's peristomal skin while maintaining sufficient tackiness and adhesive to support an ostomy pouch as it fills up with stoma effluent and to maintain leak-free seal around the stoma. In an embodiment, skin friendly ingredients may be provided such that the ostomy skin barrier or the stoma ring including the skin friendly ingredients may maintain at least about <NUM>% of the original barrier properties of the ostomy skin barrier or the stoma ring without the skin friendly ingredients. Preferably, the ostomy skin barrier or the stoma ring including the skin friendly ingredients may have substantially the same barrier properties as the ostomy skin barrier or the stoma ring without the skin friendly ingredients. Further, the ostomy barrier or the stoma ring including the skin friendly ingredients may be configured such that the peelability or removability of the ostomy skin barrier or the stoma ring from a user after use is about the same as that of the ostomy barrier or the stoma ring.

A skin barrier comprising skin friendly ingredients only on a skin contact surface or in a skin contact layer may also be used for other skin-adhering devices, such as wound dressings and the like.

Claim 1:
An ostomy wafer comprising a backing layer (<NUM>, <NUM>, <NUM>), a skin barrier (<NUM>, <NUM>, <NUM>, <NUM>), and an inlet opening (<NUM>, <NUM>, <NUM>) for receiving a stoma, wherein the skin barrier is formed from at least one skin barrier material, and the backing layer is laminated to a distal surface of the skin barrier, wherein the at least one skin barrier material is a hydrocolloid adhesive, characterised in that the skin barrier includes a skin contact layer and an inner layer, wherein at least one skin friendly ingredient is dispersed only in the skin contact layer, wherein the at least one skin friendly ingredient (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is selected from vitamin E, ceramide, cholesterol, fatty acids, micro-pockets of pH buffers, and anti-wrinkle agents.