Patent Description:
Ostomy pouches for collecting bodily waste are used by individuals who have had surgery such as a colostomy, ileostomy, or urostomy. Two common types of ostomy pouch systems are available, to wit, a one-piece pouch system and a two-piece pouch system. In a one-piece pouch system, an ostomy barrier is permanently attached to a pouch. In such a one-piece pouch system, the entire pouch system including the ostomy barrier is removed when a user wants to replace the pouch.

In a two-piece pouch system, a pouch and an ostomy barrier are provided as two separate devices. The two-piece pouch system typically includes a pair of coupling rings, one of which is fixedly attached to the ostomy barrier, while the other is attached to the pouch. The coupling rings are configured to mate with each other, such that the pouch may be securely and removeably attached to the ostomy barrier by engaging the coupling rings together. In use, the ostomy barrier is first attached to a user, and the pouch is secured to the faceplate by engaging the coupling rings together. Thus, two-piece pouch systems allow a user to remove and replace a pouch without removing the ostomy barrier from the user. This can help to reduce the discomfort and irritation associated with removing skin barrier adhesive from user's skin.

Ostomy barriers are configured to seal against peristomal skin surfaces and protect the peristomal surfaces from exposure to stomal effluent. However, the topography of stomas and peristomal surfaces surrounding stomas varies among patients, and sealing an ostomy appliance against such different peristomal surfaces and stomas remain as an area for further improvements. A person having a stoma that is flush or recessed may find that applying external support or pressure from a barrier in the peristomal region aids in directing the discharge of effluent from the stoma directly into the ostomy pouch. Accordingly, the effectiveness of an adhesive seal between the ostomy barrier and the peristomal skin surface (i.e., a seal formed by the adhesive layer) may be prolonged.

<CIT> discloses an insert (D) received within the coupling ring (<NUM>) of a faceplate of a two piece ostomy device. The coupling ring has an axially extending rib and a rigid sealing flange defined in part by a radially inwardly extending surface (<NUM>). The insert includes a convex annular body (<NUM>) with an arcuate relatively non-deformable portion and a deformable circumferential portion (<NUM>). The deformable portion has an outer edge with a circumference which is normally slightly larger than the inner circumference of the sealing flange. The circumference of the deformable portion is temporarily reduced as the insert passes through the ring. Once the insert is situated under the flange surface, the circumference returns to its normal dimension and the insert is securely seated.

<CIT> discloses a base plate comprising an adhesive wafer and a convex supporting device. An ostomy appliance comprising a base plate with an adhesive wafer and a convex supporting device.

The present disclosure provides an improved flexible convex barrier according to various embodiments.

The present disclosure provides a convex ostomy barrier assembly as detailed in claim <NUM>. Advantageous features are provided in dependent claims.

In one aspect, a convex ostomy barrier for attaching an ostomy appliance to the peristomal skin surrounding a stoma is provided. The ostomy barrier may comprise a skin barrier including an adhesive, an inlet opening for receiving a stoma, and a convex insert arranged adjacent the skin barrier. The convex insert may have a convex ring-like body and include an inner flange, an outer flange, and a middle portion arranged therebetween. The middle portion may include a pouch-side surface, a core-out portion configured to improve the flexibility of the convex insert, and a skin barrier support structure for supporting the skin barrier. The inner flange and the outer flange may be arranged in different axial planes to define the convex ring-like body. The convex ostomy barrier may also comprise a flange including a body-side coupling ring attached to the pouch-side surface of the convex insert.

In an embodiment, the skin barrier support structure may include a plurality of support structures extending axially from a body-side of the radial wall, wherein the plurality of support structures form a split ring-like shape. Each of the plurality of support structures may be surrounded by the core-out portion and include a sloped body-side surface configured to support the skin barrier having a convex body-side surface.

In another embodiment, the core-out portion may be defined by a plurality of core-out windows, and the skin barrier support structure may include a plurality of ribs. The plurality of core-out windows and the plurality of ribs may be arranged, such that adjacent ribs are spaced apart from each other by a core-out window therebetween, and each of the core-out windows is defined by a radial wall, an axial wall, and the adjacent ribs. In such an embodiment, the convex insert may include about <NUM> ribs to about <NUM> ribs.

In an embodiment, the convex insert may include a radial wall radially extending from the outer flange toward the inlet opening, and an axial wall extending axially from the radial wall in a body-side direction, wherein the inner flange
may extend from the axial wall toward the inlet opening. In such an embodiment, the outer flange, the middle portion, and the inner flange may be configured to provide a step-like protrusion in the body-side direction.

In any of the foregoing embodiments, the convex ostomy barrier may also include a tape. The convex insert may be attached to a pouch-side of the tape, and the skin barrier may be attached to a body-side of the tape. The outer flange may have a concave body-side surface configured to conform to a curved contour of a lower base section of a convex portion of the convex ostomy barrier. In such an embodiment, at least some portion of a body-side surface of the outer flange, the skin barrier support structure, or a body-side surface of the inner flange may be attached to the tape Further, at least the body-side surface of the outer flange may be heat sealed to the tape.

In any of the foregoing embodiments, the middle portion of the convex insert may include a radial wall. In such an embodiment, the pouch-side surface of the middle portion may be defined on a pouch-side of the radial wall. Further, the flange may be attached to the convex insert via a flange film, in which the flange film is attached to the pouch side surface. The pouch side surface may be generally flat, and the flange film may be heat sealed to the pouch side surface.

In another aspect, a convex insert for an ostomy barrier having a convex ring-like body is provided. The convex insert may comprise an inlet opening, an inner flange, an outer flange, and a middle portion including a pouch-side surface, a core-out portion configured to improve the flexibility of the convex insert, and a skin barrier support structure. The inner flange and the outer flange may be connected by the middle portion and arranged in different axial planes to define the convex-ring like body.

In some embodiments, the convex insert may include a radial wall radially extending from the outer flange toward the inlet opening, and an axial wall extending axially from the radial wall in a body-side direction, wherein the inner flange extends from the axial wall toward the inlet opening. In such embodiments, the outer flange, the middle portion, and the inner flange may provide a step-like protrusion in the body-side direction. The pouch-side surface may be defined on a pouch-side of the radial wall.

In an embodiment, the skin barrier support structure may include a plurality of support structures extending axially from a body-side of the radial wall, wherein the plurality of support structures form a split ring-like shape. Each of the plurality of support structures may be surrounded by the core-out portion and include a sloped body-side surface.

In another embodiment, the core-out portion may be defined by a plurality of core-out windows, and the skin barrier support structure may include a plurality of ribs. The plurality of core-out windows and the plurality of ribs may be arranged, such that adjacent ribs are spaced apart from each other by a core-out window therebetween, and each of the core-out windows is defined by a radial wall, an axial wall, and the adjacent ribs.

In yet another embodiment, the skin barrier support structure may include a ring-like structure extending axially from a body-side of the radial wall, and the core-out portion may be defined by two ring-like core-out portions. In such an embodiment, the skin barrier support structure may be arranged between the two ring-like core-out portions and have a sloped body-side surface.

In an embodiment, the skin barrier support structure may include a plurality of rod-like structures or a plurality of tube-like structures extending axially from a body-side surface of the radial wall.

In another embodiment, the core-out portion may be defined by a plurality of openings in the middle section, and the skin barrier structure may be provided between the plurality of openings on the body-side of the middle portion.

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 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.

Referring to <FIG>, an ostomy barrier <NUM> according to an embodiment is shown with a portion removed and viewed from a pouch-side to illustrate a layered construction of the ostomy barrier <NUM>. The ostomy barrier <NUM> may be configured as an ostomy barrier for a two-piece pouch system, and may generally include a skin barrier <NUM>, a flange <NUM>, a convex insert <NUM>, release liners <NUM>, <NUM>, and an inlet opening <NUM> for receiving a stoma.

The flange <NUM> may include a body-side coupling ring <NUM> for attaching an ostomy pouch. The body-side coupling ring <NUM> may be configured to mate with a pouch-side coupling ring (not shown), such that the ostomy pouch may be mechanically secured to the ostomy barrier <NUM> when the coupling rings are engaged with each other. The flange <NUM> may be attached to the convex insert <NUM> via a flange film <NUM>. In the embodiment of <FIG>, the flange <NUM> is attached to a pouch-side surface of the flange film <NUM> proximate an outer periphery of the flange film <NUM>. The convex insert <NUM> is attached to a body-side surface of the flange film <NUM> proximate an inner peripheral portion of the flange film <NUM>, such that the flange <NUM> and the convex insert <NUM> are attached on the opposite surfaces of the flange film <NUM> at opposite ends. Such a configuration provides a floating flange feature, in which a user may insert his/her finger between the flange <NUM> and the convex insert <NUM> to facilitate engagement of the coupling rings to attach a pouch to the ostomy barrier <NUM>.

The skin barrier <NUM> may be arranged on the body-side surface of the ostomy barrier <NUM> for attachment to a user. The inlet opening <NUM> may be defined by an inner periphery of the skin barrier <NUM> for receiving a stoma (not shown. ) The skin barrier <NUM> may be formed from a suitable medical-grade adhesive that can adhesively secure the ostomy barrier <NUM> to a patient's skin in the peristomal region, such as a hydrocolloid adhesive composition.

The ostomy barrier <NUM> may also include a tape <NUM> including an adhesive layer <NUM> and a backing layer <NUM>. In some embodiments, the skin barrier <NUM> may include a backing layer <NUM> laminated on the pouch-side surface of the skin barrier <NUM>. The backing layer <NUM> may be formed from a suitable heat sealable polymeric material, such that the backing layer <NUM> may be heat sealed to the tape <NUM>.

In the embodiment of <FIG>, the skin barrier <NUM> is attached to a portion of the adhesive layer <NUM> proximate the inlet opening <NUM> with the backing layer <NUM> therebetween. In such an embodiment, an outer peripheral portion of the adhesive layer <NUM> may be attached to a user surrounding the skin barrier <NUM> to provide additional security.

The adhesive layer <NUM> of the tape <NUM> may be formed from a suitable medical adhesive, such as an acrylic adhesive. The backing layer <NUM> may be formed from a suitable material, such as a nonwoven material or a thin polymeric film.

In other embodiments, the ostomy barrier <NUM> may not include the tape <NUM>. In such an embodiment, the skin barrier <NUM> may be the only means for attaching the ostomy barrier <NUM> to a user.

In the embodiment of <FIG>, the convex insert <NUM> is attached to the backing layer <NUM> of the tape <NUM> to provide a convexity to the skin barrier <NUM>. In other embodiments, the convex insert <NUM> may be attached to a pouch-side surface of the skin barrier <NUM>.

<FIG> are illustrations of the convex insert <NUM> according to an embodiment. The convex insert <NUM> may be configured to protrude axially toward a body-side direction as shown in <FIG> and <FIG> to provide a convex ring-like shaped body configured to apply pressure around the peristomal area when the ostomy barrier <NUM> is attached to a user. The convex insert <NUM> may include an outer flange <NUM>, a middle portion <NUM>, and an inner flange <NUM>, and a radial wall <NUM> providing a generally flat pouch-side surface <NUM> on a pouch-side of the convex insert <NUM> for attachment of the flange <NUM>. As best shown in <FIG> and <FIG>, the outer flange <NUM> may include a concave body-side surface <NUM>, which is configured to conform to a curved contour of a lower base portion <NUM> of a convex portion of the skin barrier <NUM>.

In this embodiment, the radial wall <NUM> including the pouch-side surface <NUM> is provided in the middle portion <NUM>. The middle portion <NUM> also may include a plurality of core-out windows <NUM> configured to improve the flexibility of the convex insert <NUM> and a support structure <NUM> on the body-side of the convex insert <NUM> for supporting the skin barrier <NUM>. For example, a plurality of ribs <NUM> may be provided on the body-side to support the skin barrier <NUM> as shown in <FIG>. In this embodiment, the plurality of ribs <NUM> and the plurality of core-out windows <NUM> may be arranged, such that adjacent ribs <NUM> are spaced apart from each other by a core-out window <NUM> therebetween. Each of the core-out windows <NUM> may be defined by the radial wall <NUM>, which radially extends from the outer flange <NUM> toward the inlet opening <NUM>, and an axial wall <NUM>, which axially extends from the radial wall <NUM> toward a body-side direction, and two adjacent ribs <NUM>. The inner flange <NUM> may radially extend from the axial wall <NUM> toward the inlet opening <NUM> as shown in <FIG> and <FIG>.

In such an embodiment, the middle portion <NUM> is configured to provide a step-like protrusion in the body-side direction from the outer flange <NUM> to the inner flange <NUM>. The lengths of the radial wall <NUM> and/or axial wall <NUM> may be adjusted to provide a desired convexity angle α and a convexity depth D.

The convex insert <NUM> may be configured to include about <NUM> ribs to about <NUM> ribs, preferably about <NUM> ribs to about <NUM> ribs, and more preferably to about <NUM> ribs to about <NUM> ribs. In the embodiment of <FIG>, the convex insert <NUM> includes eighteen ribs. As shown, in <FIG>, which is an expanded view of the rib <NUM> and the core-out window <NUM> of <FIG>, each of the rib <NUM> extends from the outer flange <NUM> to the inner flange <NUM>. The thickness of each of the rib <NUM> may taper from the outer flange <NUM> to the inner flange <NUM>, such that an outer thickness t<NUM> may be greater than an inner thickness t<NUM>.

In the embodiment of <FIG>, each of the ribs <NUM> has an outer thickness t<NUM> of about <NUM> (<NUM> inches) and an inner thickness t<NUM> of about <NUM> (<NUM> inches). In another embodiment, each of the rib <NUM> may be configured to have an outer thickness t<NUM> of about <NUM> (<NUM> inches) and an inner thickness t<NUM> of about <NUM> (<NUM> inches). Yet in another embodiment, each of the rib <NUM> may be configured to have an outer thickness t<NUM> of about <NUM> (<NUM> inches) and an inner thickness t<NUM> of about <NUM> (<NUM> inches). The number of ribs and the thicknesses of the ribs may be adjusted to provide a desired flexibility of the convex barrier <NUM>. For example, the number of the ribs and/or the thicknesses of the ribs may be increase to provide a more rigid convex barrier <NUM>. Similarly, the number of the ribs and/or the thicknesses of the ribs may be decreased to prove a more flexible soft convex barrier <NUM>.

In the embodiment of <FIG>, the flange film <NUM> may be attached to the pouch-side surface <NUM> to secure the flange <NUM> to the convex insert <NUM>. For example, the flange film <NUM> may be heat sealed to the pouch-side surface <NUM>. As shown in <FIG>, the body-side surfaces of the outer flange <NUM>, the plurality of ribs <NUM>, and the inner flange <NUM> may be in contact with the tape <NUM>, wherein at least some portions of which are attached to the backing layer <NUM>. For example, the body-side surface of the outer flange <NUM> may be heat sealed to the backing layer <NUM> of the tape <NUM>. In another example, an adhesive may be applied on the body-side surface of the convex insert <NUM> for attachment of the tape <NUM>.

The convex insert <NUM> may be formed from a suitable material, such as polymeric materials, rubber, silicone, or metallic materials. For example, the convex insert <NUM> may be formed from a heat sealable thermoplastic material, such as ethylene vinyl acetate (EVA), thermoplastic elastomer, or thermoplastic urethane. In another example, the convex insert <NUM> may be formed from a foam or silicone. The convex insert <NUM> may be formed via thermoforming or other known methods. The convex insert <NUM> may be configured to have a thickness t<NUM> of about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches), preferably about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches), and more preferably about <NUM> (<NUM> inches) to about <NUM> (<NUM> inches). In the embodiment of <FIG>, the convex insert <NUM> is configured to have a thickness t<NUM> of about <NUM> (<NUM> inches). In another embodiment, the convex insert <NUM> is configured to have a thickness t<NUM> of about <NUM> (<NUM> inches). In yet another embodiment, the convex insert <NUM> is configured to have a thickness t<NUM> of about <NUM> (<NUM> inches).

A release liner may be provided to cover the skin barrier <NUM> and the tape <NUM>. In the embodiment of <FIG>, the release liner <NUM> is provided to cover an outer peripheral portion of the tape <NUM>, and the release liner <NUM> is provided to cover the entire body-side surface of the ostomy barrier <NUM> including the skin barrier <NUM> and the tape <NUM>. In use, the release liner <NUM> may be removed first for attachment of the skin barrier <NUM> to peristomal skin, and the release liner <NUM> may be removed subsequently to expose the tape <NUM> for further attachment to user's skin.

In the convex insert <NUM> of <FIG>, body-side surfaces of the radial wall <NUM> and the axial wall <NUM> are generally flat, such that an intersection of the radial wall <NUM> and the axial wall <NUM> forms a generally <NUM>° angle. In other embodiments, a body-side surface of the plurality of core-out windows <NUM> may be curved proximate the intersection. <FIG> is a cross sectional view of a convex insert <NUM> including a plurality of core-out windows <NUM> having a curved body-side surface <NUM> according to an embodiment. In this embodiment, the curved body-side surface <NUM> provides a convex contour similar to the convex outer contour of the ribs <NUM>. In another embodiment, the body-side surfaces of the radial wall <NUM> and the axial wall <NUM> may from a one continuous concave surface similar to the concave body-side surface <NUM> of the outer flange <NUM>.

<FIG> illustrate a convex insert <NUM> according to yet another embodiment. The convex insert <NUM> may have convex ring-like shaped body <NUM> including an outer portion <NUM> and a convex inner portion <NUM>. As it was with the convex inserts <NUM>, <NUM>, the convex insert <NUM> may be configured to protrude axially toward a body-side direct as shown in <FIG> and <FIG> to provide the convex ring-like shaped body. The outer portion <NUM> may include a concave body-side surface <NUM>, while the inner portion <NUM> may include a convex body-side surface <NUM>. The convex insert <NUM> may also include an axial wall <NUM> axially extending from a pouch-side surface of the inner portion <NUM> forming a cylindrical wall structure and a pouch-side surface <NUM> for attachment of a flange <NUM> as best shown in <FIG>. A plurality of windows <NUM> may be provided along an inner surface <NUM> of the axial wall <NUM>.

<FIG> are illustrations of a convex insert <NUM> according to an embodiment. The convex insert <NUM> may be configured similar to the convex insert <NUM> of <FIG> including a convex ring-like shaped body for applying pressure around the peristomal area when the ostomy barrier <NUM> is attached to a user. The convex insert <NUM> may comprise an outer flange <NUM>, a middle portion <NUM>, and an inner flange <NUM>. The middle portion may include a radial wall <NUM> providing a generally flat pouch-side surface <NUM> for attaching a flange <NUM>, core-out portions <NUM> configured to improve the flexibility of the convex insert <NUM>, and a plurality of support structures <NUM> protruding axially from a body-side surface of the radial wall <NUM> for supporting a skin barrier <NUM>. In this embodiment, the plurality of support structures <NUM> forms a split ring-like shape as shown in <FIG>. The outer flange <NUM> may extend beyond the radial wall <NUM> to form a protrusion <NUM>, and each of the plurality of support structures <NUM> may include a sloped surface <NUM>, such that the inner flange <NUM>, the plurality of support structures <NUM> and the protrusion <NUM> may provide a concave line of support <NUM> shown in phantom lines in <FIG> for the skin barrier <NUM>.

<FIG> are illustrations of convex inserts according to various embodiments. These convex inserts are configured similar to the convex inserts <NUM>, <NUM> having a convex ring-like shaped body and generally include an outer flange, a middle portion, and an inner flange. The middle portion may include a generally flat pouch-side surface for attaching a flange, core-out portions, and a support structure on the body side for supporting a skin barrier. The support structure of these embodiments may be provided in various shapes and forms. For example, the convex insert <NUM> of <FIG> may include a support structure <NUM> that is configured similar to the support structure <NUM> of <FIG>, except the support structure <NUM> is provided as a single continuous ring-like structure. A support structure <NUM> of the convex insert <NUM> of <FIG> may be configured similar to the support structure <NUM> of <FIG>, except the support structure <NUM> is provides as a wavy ring-like structure.

The convex insert <NUM> of <FIG> may be configured similar to the convex insert <NUM> generally comprising an outer flange <NUM>, a middle portion <NUM>, an inner flange <NUM>, a generally flat pouch-side surface for attachment of a flange and a plurality of support structures <NUM> for supporting a skin barrier. In this embodiment, the plurality support structures <NUM> may be provided as rib-like structures defined between a plurality of core-out windows <NUM>, which may undercut below the inner flange <NUM> to provide core-out portions thereunder.

The convex insert <NUM> of <FIG> may comprise a plurality of support structures <NUM> axially extending from a radial wall <NUM>. The plurality of support structures <NUM> may include a plurality of taller rod-like structures <NUM> and a plurality of shorter rod-like structures <NUM>. In this embodiment, the convex insert <NUM> may include the same number of the taller rod-like structures <NUM> and the shorter rod-like structures <NUM>. The taller rod-like structures <NUM> may be arranged in a circle concentric to an inlet opening <NUM>, while the shorter rod-like structures <NUM> may be arranged in a circle surrounding the taller rod-like structures <NUM> and concentric to the inlet opening <NUM>. Further, the taller rod-like structures <NUM> and the shorter rod-like structures <NUM> may be aligned radially in pairs as shown in <FIG>. The each of the taller rod-like structures <NUM> and the shorter rod-like structures <NUM> may include a sloped body-side surface configured to provide a support for a skin barrier <NUM> similar to the plurality of support structures <NUM> of <FIG>. The convex insert <NUM> of <FIG> may include a plurality of support structures <NUM> configured similar to the plurality of support structures <NUM> of <FIG>, except taller rod-like structures <NUM> and shorter rod-like structures <NUM> are staggered and are not radially aligned in pairs.

The convex insert <NUM> of <FIG> may comprise a plurality of support structures <NUM> axially extending from a radial wall <NUM>, each of which having a tube-like body including an opening <NUM> and a sloped body-side surface <NUM> for supporting a skin barrier <NUM>. The convex inserts <NUM>, <NUM>, <NUM> of <FIG> are similarly configured comprising an outer flange <NUM>, <NUM>, <NUM>, a middle portion <NUM>, <NUM>, <NUM>, an inner flange <NUM>, <NUM>, <NUM>, a generally flat pouch-side surface for attachment of a flange, a plurality of core-out portions <NUM>, <NUM>, <NUM>, and a support structure <NUM>, <NUM>, <NUM> defined therebetween for supporting the skin barrier <NUM>.

Claim 1:
A convex ostomy barrier assembly (<NUM>) for attaching an ostomy appliance to a peristomal skin surrounding a stoma, the convex ostomy barrier assembly comprising:
a skin barrier (<NUM>) comprising an adhesive;
an inlet opening (<NUM>) for receiving a stoma;
a convex insert (<NUM>) arranged adjacent the skin barrier, the convex insert having a convex ring-like body and comprising:
an inner flange (<NUM>);
a middle portion (<NUM>) including a pouch-side surface, a core-out portion (<NUM>), and a skin barrier support structure (<NUM>) for supporting the skin barrier; and
an outer flange (<NUM>), wherein the inner flange and the outer flange are connected by the middle portion and arranged in different axial planes to define the convex-ring like body; and
a flange (<NUM>) including a body-side coupling ring (<NUM>) attached to the pouch-side surface of the convex insert, characterized in that the middle portion (<NUM>) includes a radial wall (<NUM>), wherein the pouch-side surface of the middle portion is defined on the radial wall, wherein the flange is attached to the convex insert via a flange film (<NUM>), and wherein the flange film is attached to the pouch-side surface.