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.

The present disclosure provides an improved flexible convex barrier and a method of making convex barriers of various softness/hardness according to various embodiments.

<CIT> discloses a convex ostomy barrier includes a skin barrier, an inlet opening for receiving a stoma, and a convex insert. The convex insert includes an inner flange, an outer flange, and a middle portion arranged therebetween. The middle portion includes a pouch side surface for attaching a flange, 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 present disclosure provides a convex ostomy barrier for attaching an ostomy appliance to a peristomal skin surrounding a stoma according to claim <NUM>, and a method of making convex ostomy barriers of various softness/hardness according to claim <NUM>. Advantageous features are provided in dependent claims.

In one aspect, a convex ostomy barrier for attaching an ostomy appliance to a peristomal skin surrounding a stoma as set out in claim <NUM> is provided.

In an embodiment, the convex insert may include a core-out portion configured to receive the ring. In such an embodiment, the ring may be arranged in the core-out portion of the convex insert to form the convex insert system having a convex ring-like body. The convex insert may include an inner flange, a middle portion including the core-out portion, and an outer flange. The inner flange and the outer flange may be connected by the middle portion and arranged in different axial planes, wherein the convex insert system is configured to support the skin barrier on a body-side surface. 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 core-out portion is defined by the radial wall and the axial wall on a body-side. The inner flange may extend from the axial wall toward the inlet opening, and wherein the outer flange, the middle portion, and the inner flange provides a step-like protrusion in the body-side direction.

In some embodiments, the convex ostomy barrier may be configured for a two-piece ostomy pouch system comprising a flange including a coupling ring. The flange may be attached to a pouch-side surface of the radial wall of the convex insert.

The convex ostomy barrier of any of the foregoing embodiments may be configured such that the convex ostomy barrier of various softness/hardness may be provided by using different rings in the convex insert system. For example, the convex ostomy barrier may be configured to have a first softness/hardness by incorporating the convex insert system formed from the convex insert and the ring having a first characteristic, or configured to have a second softness/hardness different than the first softness/hardness by incorporating the convex insert system formed from the convex insert and the ring having a second characteristic.

In another aspect, a method of making convex ostomy barriers of various softness/hardness as set out in claim <NUM> is provided.

In an embodiment, the plurality of the rings may include a first ring having a first characteristic and a second ring having a second characteristic. The convex insert may be assembled with the first ring to form a first convex insert system for a first convex ostomy barrier, or the convex insert may be assembled with the second ring to form a second convex insert system for a second convex ostomy barrier, wherein the first convex ostomy barrier has a first softness/hardness and the second convex ostomy barrier has a second softness/hardness that is different than the first softness/hardness.

In some embodiments, the step of providing a convex insert and plurality of rings may include the step of providing the convex insert including a core-out portion configured to receive one of the plurality of rings. In such embodiments, the step of assembling the convex insert and the selected ring may comprise arranging the selected ring in the core-out portion of the convex insert to form the convex insert system having a convex ring-like body. The convex insert may include an inner flange, a middle portion including the core-out portion, and an outer flange, wherein the inner flange and the outer flange are connected by the middle portion and arranged in different axial planes. The convex insert system may be configured to support the skin barrier on a body-side surface.

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 core-out portion is defined by the radial wall and the axial wall on a body-side. The inner flange may extend from the axial wall toward the inlet opening, wherein the outer flange, the middle portion, and the inner flange provide a step-like protrusion in the body-side direction.

The method of any of the foregoing embodiments may further include the step of providing a flange including a coupling ring, wherein the flange is attached to a pouch-side surface of the radial wall of the convex insert.

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>, a convex 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 convex ostomy barrier <NUM>. The convex ostomy barrier <NUM> may be configured for a two-piece pouch system, and may generally comprise a skin barrier <NUM>, a flange <NUM>, a convex insert system <NUM>, release liners <NUM>, <NUM>, and an inlet opening <NUM> for receiving a stoma.

<FIG> are illustrations of the convex insert system <NUM> including a convex insert <NUM> and a ring <NUM> according to an embodiment. The convex insert <NUM> and the ring <NUM> may be configured to be assembled together to form the convex insert system <NUM> having a convex ring-like shaped body. The convex insert system <NUM> may be configured to provide the convexity of the convex ostomy barrier <NUM> to apply pressure around the peristomal area when the convex ostomy barrier <NUM> is attached to a user.

The softness/hardness of the convex ostomy system <NUM> may be determined by the combined softness/hardness of the convex insert <NUM> and the ring <NUM>. As such, the softness/hardness of the convex ostomy system <NUM> may be easily altered or controlled by incorporating a ring <NUM> having a different softness/hardness. Such a feature may provide significant cost savings since convex ostomy barriers <NUM> of various convexity hardness/softness may be manufactured by making and incorporating rings <NUM> of various softness/hardness, instead of making convex inserts of various softness/hardness.

In <FIG>, the convex insert <NUM> is illustrated with three rings <NUM>, <NUM>', <NUM>". Each of the rings <NUM>, <NUM>', <NUM>" may be configured to have a different softness/hardness. As such, a convex insert system prepared by assembling the convex insert <NUM> and the ring <NUM> may provide a first softness/hardness, and a convex insert system prepared by assembling the convex insert <NUM> and the ring <NUM>' may provide a second softness/hardness that is different from the first softness/hardness, and a convex insert system prepared by assembling the convex insert <NUM> and the ring <NUM>" may provide a third softness/hardness that is different from the first or second softness/hardness.

The convex insert <NUM> may be configured to protrude axially toward a body-side direction and configured to receive the ring <NUM> as shown in <FIG>. 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>. 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>. The radial wall <NUM> including the pouch-side surface <NUM> may be arranged in the middle portion <NUM>. The middle portion <NUM> also may include a core-out portion <NUM> configured to receive the ring <NUM>. The core-out portion <NUM> may be defined by the radial wall <NUM>, which may radially extend from the outer flange <NUM> toward the inlet opening <NUM>, and an axial wall <NUM>, which may axially extend from the radial wall <NUM> toward a body-side direction. The inner flange <NUM> may radially extend from the axial wall <NUM> toward the inlet opening <NUM>. The middle portion <NUM> may be configured to provide a step-like axial protrusion in the body-side direction from the outer flange <NUM> to the inner flange <NUM>.

The ring <NUM> may have a relatively thin ring-like body as shown in <FIG>. The ring <NUM> may be configured such that the pouch-side of the ring <NUM> may fit in the core-out portion <NUM> of the convex insert <NUM> as best shown in FIGS. 4B60
and <NUM>. In an embodiment, the ring <NUM> may include a radial pouch-side surface <NUM> and an axial pouch-side surface <NUM>, and a sloped body-side surface <NUM>. When received in the core-out portion <NUM> of the convex insert <NUM>, the radial pouch-side surface <NUM> may be arranged adjacent the radial wall <NUM> of the convex insert <NUM> and the axial pouch-side surface <NUM> may be arranged adjacent the axial wall <NUM> of the convex insert <NUM>. In such an embodiment, the body-side surface of the inner flange <NUM> of the convex insert <NUM>, the sloped body-side surface <NUM> of the ring <NUM>, and the body-side surface of the outer flange <NUM> of the convex insert <NUM> may form a generally continuous body-side surface of the convex insert system <NUM> as shown in <FIG>.

The convex insert <NUM> and the ring <NUM> may be formed from the same or different materials. Suitable materials for the convex insert <NUM> and the ring <NUM> may include, but are not limited to, polymeric materials, rubber, silicone, and metallic materials. For example, the convex insert <NUM> and the ring <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> and the ring <NUM> may be formed from a foam or silicone.

In <FIG>, the convex insert system <NUM> is used in the convex ostomy barrier <NUM> for a two-piece pouch system, which may include the flange <NUM> having a body-side coupling ring <NUM> for attaching an ostomy pouch. In other embodiments, the convex insert system <NUM> including the convex insert <NUM> and the ring <NUM> may be used in a convex ostomy barrier for a one-piece pouch system. 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> may be 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 system <NUM> may be 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 system <NUM> may be attached to a pouch-side surface of the skin barrier <NUM>.

In the embodiment of <FIG>, the flange film <NUM> may be attached to the pouch-side surface <NUM> of the convex insert <NUM> to secure the flange <NUM>. For example, the flange film <NUM> may be heat sealed to the pouch-side surface <NUM> of the convex insert <NUM>. As shown in <FIG>, the body-side surfaces of the outer flange <NUM> of the convex insert <NUM>, the sloped body-side surface <NUM> of the ring <NUM>, and the body-side surface of the inner flange <NUM> of the convex insert <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 provided on the body-side surface of the convex insert system <NUM> for attachment to the tape <NUM>.

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.

Claim 1:
A convex ostomy barrier (<NUM>) for attaching an ostomy appliance to a peristomal skin surrounding a stoma, the convex ostomy barrier comprising:
a skin barrier (<NUM>) formed from a skin friendly adhesive;
an inlet opening (<NUM>) for receiving a stoma; and
a convex insert system (<NUM>) arranged adjacent the skin barrier and configured to provide a convex body-side contour of the convex ostomy barrier, wherein the convex insert system includes a convex insert (<NUM>) and a plurality of rings (<NUM>, <NUM>', <NUM>") including a first ring having a first characteristic and a second ring having a second characteristic, wherein the convex insert and one of the plurality of rings are configured to be assembled together to form the convex insert system, wherein the convex ostomy barrier (<NUM>) is configured to have a first softness/hardness comprising the convex insert system formed from the convex insert (<NUM>) and the first ring (<NUM>), wherein the convex ostomy barrier (<NUM>) is configured to have a second softness/hardness comprising the convex insert system formed from the convex insert (<NUM>) and the second ring (<NUM>'); wherein the first softness/hardness is different from the second softness/hardness and the first characteristic is different from the second characteristic.