Patent Description:
Ostomy pouches for the collection of body waste output from a stoma are well known and used by individuals who have had surgery such as a colostomy, ileostomy or urostomy. Ostomy pouches are generally attached to a user via an ostomy barrier, which is 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 can vary among patients and providing a single ostomy appliance which can effectively seal against such different peristomal surfaces and stomas can be particularly challenging. For example, a stoma may protrude more or less, or may even be flush or recessed.

A person with an ostomy 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 which can prevent undesirable leakage of body waste output between the barrier and the 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. Thus, convex inserts and convex ostomy barriers, such as ADAPT® convex barrier rings available through the assignee of the present application, have been developed to apply pressure around such peristomal regions.

However, the convexity of a conventional convex ostomy barrier or insert is fixed and may not work efficiently for all ostomates. Thus, convex ostomy barriers and convex inserts of various convexity depths have been made available in the market. Further, an ostomate may wish to incrementally adjust the convexity of an ostomy barrier to achieve an optimal convexity for his/her topography of stoma.

<CIT> discloses a pliable skin barrier ring adapted for placement in a skin fold or crease located around a stoma of a user. The pliable barrier ring includes a first layer of a relatively harder adhesive material having a proximal surface and a distal surface. The pliable barrier ring further includes a second layer of relatively softer adhesive material provided at least on the proximal surface of the first layer of adhesive material. The first adhesive layer includes a relatively thicker bulk portion located in a central portion of the ring, and a relatively thinner flange portion extending radially inwards from an outer peripheral edge of the ring and transitioning into the bulk portion. The relatively thicker bulk portion provides a proximally projecting expanded shape to the central portion of the ring.

<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.

<CIT> discloses an ostomy barrier appliance for attaching an ostomy appliance to peristomal skin surrounding a stoma. The ostomy barrier appliance includes a skin barrier, an inlet opening for receiving a stoma, and a convexity adjusting device arranged adjacent the skin barrier. The convexity adjusting device is configured to adjust the convexity of the skin barrier.

Accordingly, for at least the above-noted reasons, there is a critical need in the art for a customizable ostomy appliance that can accommodate a variety of stomal features and provide a desired degree of convex support to particular localized regions around the stoma inlet/opening. There is further a desire to provide a customizable ostomy appliance that can provide varying degrees of support around the stoma inlet/opening and that can enable a user to adjust or set the amount of flexibility or rigidity to different support regions. There is further a need in the art for an ostomy appliance that can provide the necessary flexibility upon application without compromising the structural rigidity as a support when in use.

Embodiments presented herein are directed to an ostomy appliance comprising a ring member and a rib member. The ring member can have an interior surface and an engagement portion encircling a centrally-located input opening. The engagement portion can comprise a plurality of spaced-apart flexible tabs extending radially inward into the input opening. The flexible tabs can have opposing side edges and opposing interior and exterior surfaces with an opening extending therebetween. The opening can be centrally located between the opposing side edges. A plurality of spaced-apart teeth can extend radially inward from the inside surface of the ring member into the input opening. The teeth can be in alignment in a first direction with spaces between the plurality of flexible tabs and can have an inside surface facing the interior surface of the plurality of flexible tabs.

According to embodiments presented herein, the rib member can have a curved body portion with opposing inside and outside surfaces joined together by opposing top and bottom edges and opposing side edges. The rib member can have a dowel, pins and a notched section in the body portion. The dowel can extend radially inward from the inside surface of the body portion. The pins can extend axially away from the top edge of the body portion. The notched section can form a recess along the inside surface and bottom edge of the body portion. The rib member can be removably securable to the ring member whereby the pins of the rib member can be insertable into openings of adj acent flexible tabs of the plurality of flexible tabs and a first tooth of the plurality of spaced-apart teeth in alignment in the first direction with a space between the adjacent flexible tabs is received within the notched section of the rib member. The notched section can be seated on the inside surface of the tooth.

According to embodiments presented herein the ring member can further comprise an outer flange and a middle portion. The middle portion can be between the outer flange and the engagement portion and can be curved to elevate the engagement portion from the outer flange in the first direction. The plurality of spaced apart flexible tabs can encircle the entirety of the engagement portion and the input opening. Each of the plurality of spaced-apart tabs can be substantially equivalent in size and can be spaced a same distance apart from adjacent ones of the plurality of flexible tabs. A first distance can separate the openings of the adjacent flexible tabs and the pins of the rib member can be reciprocally spaced apart from one another by said first distance. The first tooth can be spaced halfway between the openings of the adjacent flexible tabs in a second direction perpendicular to the first direction. The ring member can be provided as an insert between layers of an ostomy barrier. The ring member can be removably securable to an ostomy barrier securable to a user. The plurality of spaced-apart flexible tabs can be curved. Upon being applied to a user, the inside surface of the plurality of flexible tabs can be configured to engage an adjacent parastomal region of the user and pull the adjacent parastomal region towards a pouch-side of the ring member. Upon securing the rib member to the ring member, the adjacent flexible tabs can have reduced flexibility. A plurality of rib members substantially identical to the rib member can be further provided, each of the plurality of rib members can be removably securable and repositionable between adjacent tabs of the plurality of flexible tabs and a tooth of the plurality of spaced apart teeth positioned between the adjacent tabs.

Embodiments presented herein are further directed to a convex support for an ostomy appliance. The convex support can comprise an annular ring member having an interior surface and an engagement portion encircling a centrally-located input opening. The engagement portion can comprise a plurality of spaced-apart flexible tabs extending radially inward into the input opening. The flexible tabs can have opposing side edges and opposing interior and exterior surfaces with an opening extending therebetween. The opening can be centrally located between the opposing side edges. A plurality of spaced-apart teeth can extend radially inward from the inside surface of the ring member into the input opening. The teeth can be in alignment in a first direction with spaces between the plurality of flexible tabs and can have an inside surface facing the interior surface of the plurality of flexible tabs.

According to embodiments presented herein, the convex support can further comprise a rib member. The rib member can have a curved body portion with opposing inside and outside surfaces joined together by opposing top and bottom edges and opposing side edges. The rib member can have a dowel, pins and a notched section in the body portion. The dowel can extend radially inward from the inside surface of the body portion. The pins can extend axially away from the top edge of the body portion. The notched section can form a recess along the inside surface and bottom edge of the body portion. The rib member can be removably securable to the ring member whereby the pins of the rib member can be insertable into openings of adjacent flexible tabs of the plurality of flexible tabs and a first tooth of the plurality of spaced-apart teeth in alignment in the first direction with a space between the adjacent flexible tabs is received within the notched section of the rib member. The notched section can be seated on the inside surface of the tooth.

According to embodiments presented herein the plurality of flexible tabs of the convex support can comprise sixteen tabs that encircle the entirety of the engagement portion and the input opening. Each of the sixteen tabs can be substantially equivalent in size and being spaced a same distance apart from one another. The plurality of spaced-apart teeth can comprise sixteen teeth equivalently spaced apart from one another around the interior side of the ring member. A plurality of rib members substantially identical to the rib member can further be provided and the plurality of rib members can be of a quantity between two and eight. The plurality of spaced-apart teeth can comprise a distal end having an elevated barbed section to retain the rib member thereon. The plurality of spaced-apart teeth can comprise the first tooth, a second tooth and a third tooth located in sequence along a portion of the ring member and the plurality of spaced apart flexible tabs can comprise a first and second tab. The first tab can be aligned in the first direction between the first tooth and the second tooth and the second tab can be aligned in the first direction between the second tooth and the third tooth.

According to embodiments presented herein, the rib member of the convex support can be secured to the ring member. A first portion of the bottom edge of the body portion can be between the first tooth and the second tooth and a second potion of the bottom edge of the body portion can be between the second tooth and the third tooth. The rib member can comprise a first rib member and a second rib member substantially identical to the first rib member. The first and second rib members can be securable to the ring member in adjacent positions alongside one another and upon being secured in the adjacent positions, the first tooth can be between one of the opposing side edges of the first rib member and one of an opposing side edge of the second rib member. The rib member can be securable to the ring member by being snap fit thereon whereby the outside surface of the rib member snaps into place against the interior surface of the ring member.

Other objects, advantages and features of the present disclosure will be understood and appreciated by persons of ordinary skill in the art from consideration of the following specification taken in conjunction with the accompanying drawings.

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 now to the accompanying figures, and <FIG> in particular, a convex ring member <NUM> is shown according to embodiments. As shown schematically in <FIG>, convex ring member <NUM> can have an outer flange <NUM>, a middle portion <NUM> and an interior stoma engagement portion <NUM> comprising a plurality of spaced apart flexible tabs 18a. n arranged around an inlet opening configured for receiving at least a portion of a stoma. According to embodiments, convex ring member <NUM> can be securable to, or integrated within, an ostomy skin barrier (not shown) and protrude axially toward a body-side direction to provide a convex ring-like shaped body configured to apply pressure around the peristomal area. More particularly, as shown in <FIG>, convex ring member <NUM> can have a body-side surface <NUM> and an ostomy pouch-side surface <NUM> that can be securable to the ostomy barrier which can in turn be removably coupled or secured to an ostomy pouch (not shown). Alternatively, convex ring member can be provided as an insert between layers of an ostomy barrier.

As shown schematically in <FIG>, middle portion <NUM> between outer flange <NUM> and engagement portion <NUM> can have a curved or elevated contour to provide depth to ring member <NUM>. According to embodiments convex ring member <NUM> including outer flange <NUM>, middle portion <NUM> and engagement portion <NUM> can be comprised of a flexible biocompatible material such as silicone or other polymeric materials which can allow the ring member10 to bend or flex. Such flexibility can be important upon application of the ring member10 to the user as well as from the perspective of flexibly supporting the peristomal region. As shown in <FIG> and <FIG>, ring member <NUM> can have an annular configuration with a round outer edge. It will be understood however that ring member <NUM> can have alternate shapes and sizes without limitation.

As best shown in <FIG>, flexible tabs 18a. n can be arranged entirely around engagement portion <NUM> and extend radially inward into the inlet opening. n can have side edges and opposing interior and exterior surfaces <NUM>, <NUM> with a thickness therebetween. As shown in <FIG>, an opening <NUM> can extend through the thickness of each of the tabs 18a. Opening <NUM> can be centrally located between the side edges of tabs 18a. As shown schematically in <FIG>, tabs 18a. n can have a distal end <NUM> having a smooth surface suitable for engagement with locations of the peristomal surface. n can taper as they extend inward toward distal end <NUM> such that the side edges are closer together at the distal end <NUM> than at an opposing proximal end adjacent middle potion <NUM>. As shown in <FIG> and <FIG>, tabs 18a. n can have a bowed or curved shape between the proximal and distal <NUM> ends. In ordinary use, it will be understood that when ring member <NUM> is being applied to a user, it may be configured to press against the peristomal skin to facilitate the stoma to project outward to better direct discharge into an associated pouch.

According to embodiments shown schematically in <FIG> and <FIG>, tabs 18a. n can be evenly spaced apart from one another with gaps or recesses therebetween; the recesses being defined by the side edges of adjacent tabs. As shown in <FIG> and <FIG>, tabs 18a. n can be identically sized and evenly spaced around the entirety of engagement portion <NUM> such that the distance between centrally-located openings <NUM> of adjacent tabs can be consistent around the entirety of engagement portion <NUM>. Similarly, the size of the recesses between adjacent tabs 18a. n and distance between adjacent recesses can also be substantially identical around the entirety of engagement portion <NUM>. For example, the size of the recesses between adjacent tabs 18a. n and distance between adjacent recesses can be such that there is no functional difference between them around the entirety of engagement portion <NUM>.

<FIG> and <FIG> illustrates a cross-section views of ring member <NUM>. As shown schematically in <FIG> and. <FIG>, ring member <NUM> can have an interior surface <NUM> between the underside of the interior surface of the tabs 18a. n and the body-side <NUM> of ring member <NUM>. According to embodiments shown schematically in <FIG> and <FIG>, a plurality of flange-like teeth 36a. n can radially extend inward from the interior surface <NUM> of ring member <NUM> toward the inlet opening. As shown schematically in <FIG> and <FIG>, the teeth 36a. n can have a bottom surface that can be flush with the pouch-side <NUM> of the ring member <NUM> and an opposing top surface having a hook-like configuration comprising an proximal grooved portion adjacent the inside surface <NUM> of the insert and a distal barbed portion comprising an upwardly extending projection. As shown schematically in <FIG>, interior surface <NUM> of ring member <NUM> can be circular and at least partially define the inlet opening and be suitable for receiving a stoma therethrough.

<FIG> illustrates an insertable rib member <NUM> according to embodiments. As shown schematically in <FIG>, rib member <NUM> can have a body portion <NUM> with opposing inside and outside surfaces <NUM>, <NUM> joined together by opposing top and bottom edges <NUM>, <NUM> and opposing side edges. The body portion <NUM> of rib member <NUM> can have a curved or arcuate orientation whereby opposing the opposing side edges curve inward toward the inside surface <NUM>. As described in further detail below, rib member <NUM> can engage along the inside surface <NUM> of ring member <NUM> via snap fit and the curvature of body portion <NUM> can correspond to that of the interior surface <NUM> of the ring member.

According to embodiments shown schematically in <FIG>, rib member <NUM> can have a dowel <NUM> extending radially inward from the inside surface <NUM> of body portion <NUM> and a notched section <NUM> along the bottom edge <NUM>. As shown schematically in <FIG>, both dowel <NUM> and notched section <NUM> can be centrally located along the body portion <NUM> between the opposing side edges with the notched section extending below an underside of the dowel <NUM> to the bottom edge <NUM> of rib member <NUM>. It will be understood, however, that either or both of dowel <NUM> and notched section <NUM> can be positioned at other locations along rib member <NUM> and that rib member <NUM> can have a plurality of dowels and notched sections without limitation. As best shown in <FIG>, notched section <NUM> can form recesses within both the bottom edge and within the interior side of the body portion <NUM> of rib member <NUM>. At least a portion of notched section <NUM> can also have a back ledge extending downward below dowel <NUM>.

As shown schematically in <FIG>, rib member <NUM> can have spaced-apart pins <NUM> extending orthogonally from the top edge <NUM> of the body portion <NUM>. Pins <NUM> can be spaced apart from one another by a distance D. Pins <NUM> can be adapted to be insertable within the openings <NUM> of tabs 18a. n and it will be understood from the subject disclosure that distance D can correspond to the space between openings <NUM> in adjacent tabs <NUM> on ring member <NUM>. According to embodiments shown schematically in <FIG>, pins <NUM> can also be horizontally spaced from the center of the notched section <NUM> by a distance on the order of <NUM>/<NUM> D, and thus notched section <NUM> can be horizontally positioned half way between pins <NUM>. As described in further detail below, such orientation can enable rib member <NUM> to be removably secured along the interior surface <NUM> of ring member <NUM>.

<FIG> illustrate ring member <NUM> with a rib member <NUM> secured thereto in one representative location of a plurality of locations. According to embodiments, one or more rib members <NUM> can be removably secured to ring member <NUM> as shown in <FIG> by being snap fit thereon. As shown schematically in <FIG>, upon securing rib member <NUM> to ring member <NUM>, the pins <NUM> of rib member can be inserted into the openings <NUM> of adjacent flange members <NUM> from below and the body portion of rib member can be pressed against the interior surface <NUM> of ring member <NUM> such that the outside surface <NUM> of rib member <NUM> is flush against or adjacent the inside surface <NUM> of ring member <NUM>. Upon being pressed into ring member <NUM>, notched section <NUM> of along the bottom edge <NUM> of rib member <NUM> can receive, engage and be seated upon a tooth <NUM> located between adjacent tabs <NUM>. More particularly, the downwardly facing edge of the ledge of notched section <NUM> can be seated within the groove along the top surface of the tooth <NUM> and held in place by the upwardly projecting barb at the distal end of the tooth.

Thus, as can be seen in <FIG>, rib member <NUM> and ring member can be correspondingly sized such that rib member <NUM> can be held securely in place below adjacent flexible tabs <NUM> and a tooth <NUM> located therebetween whereby the bottom of the rib member <NUM> is supported by the top surface of the tooth <NUM> and the top of the rib member is supported by the underside of adjacent tabs <NUM>, and more particularly by engagement of the pins <NUM> within openings <NUM>. According to embodiments shown schematically in <FIG>, when the rib member <NUM> is secured to the ring member <NUM>, the sides of the body portion of rib member are flush against or adjacent side edges of alternating teeth 36a. As can be seen in <FIG>, when secured together, the dowel <NUM> of rib member can extend radially inward toward the inlet opening. In such configuration, support can be facilitated by the rib member(s) <NUM> preventing the associated tabs <NUM> from folding towards the interior surface <NUM> of the ring member <NUM> thus providing a more rigid localized support at the stomal area adjacent the rib member(s) <NUM>.

According to embodiments presented herein, the convex ring member <NUM> can be applied to a user by inserting the stoma through the inlet opening such that the ring member <NUM> encircles the stoma with the body side <NUM> facing inward towards the user's body and the pouch-side <NUM> is facing outward away from the user. In placing the ring member <NUM> around the stoma, the soft, flexible composition of the ring member <NUM> and tabs 18a. n can gently push on the peristomal skin surrounding the stoma to protrude or project the stoma outward to aid in directing the discharge of effluent from the stoma directly into the ostomy pouch. Upon being applied around the stoma, the user can apply the rib members <NUM> as desired.

From the subject disclosure, it will be recognized and appreciated, that upon application of ring member <NUM> around a stoma, the rib members <NUM> can be snapped into place along the ring member <NUM> at particular locations where the adjacent stomal area requires deeper convexity or additional firmness or rigidity to be adequately supported. According to embodiments, it will be recognized that the ring member <NUM> can alternatively be applied to a user with the rib members <NUM> already in place, such as for example, where a user has knowledge and familiarity with stomal locations that are in need of deeper convexity support and has previously customized the appliance accordingly.

It will be recognized that such capabilities can provide a more customizable ostomy appliance that is adjustable to suit the particular conditions or needs of an individual user. It will be further recognized that such capabilities can reduce the need for providing, or manufacturing multiple different types of specialized ostomy appliances to attempt to suit different individuals which can be commercially impractical. Accordingly, embodiments presented herein can provide adjustable convexity to account for stomal variations between individual users and also stomal changes that may evolve over time with regard to a specific individual user who may need additional support to different areas at different times. According to embodiments presented herein, such individual can add or reduce support to particular stomal areas by modifying use and positioning of the rib members <NUM>. It will be appreciated that such functionality can better prevent undesirable leakage of body waste output which can improve sanitation and reduce embarrassment.

<FIG> illustrate a sequence for applying and adjusting a convex adjustable ring member according to embodiments presented herein. As shown schematically in <FIG>, a low profile stoma <NUM> is shown and a deep convex customizable ring member <NUM> of the type presented herein is applied <NUM> around the stomal area. During such application, the soft flexible tabs <NUM> a. n help push <NUM> the surrounding skin of the peristomal area. Once applied, the flexible tabs 18a. n protrude the stoma <NUM> more and take the shape of the stoma. According to embodiments shown schematically in <FIG>, the rib member(s) <NUM> can be applied <NUM> to the ring member <NUM> to keep them in place and for added support. The result <NUM> can be a well-protruded stoma that can better prevent leakage.

<FIG> illustrate a further embodiment presented herein. As shown schematically in <FIG>, a ring member <NUM> is provided having characteristics similar to that of ring member illustrated in <FIG>, except that said ring member <NUM> can comprise slotted windows <NUM> around the engagement portion <NUM>. An insertable component <NUM> such as an insertable rib member can be insertable into slotted window(s) <NUM> and slidably adjusted to an area along engagement portion <NUM> requiring additional localize support for an adjacent portion of a peristomal area. As shown schematically in <FIG>, insertable component <NUM> can extend over an interior surface <NUM> of the ring member <NUM>. <FIG> illustrates an additional plan view illustrating the ring members <NUM> of <FIG> affixed to a barrier shield <NUM>. As will be understood by persons of ordinary skill in the art, ring member <NUM> of <FIG> and <FIG> can have a plurality of slotted windows within the engagement portion <NUM> which are separated by one another by breaks <NUM> at opposing ends. The slotted windows can completely encircle the engagement portion <NUM> to enable variable placement of insertable component(s) <NUM> at multiple different locations around ring member <NUM>. As shown schematically in <FIG>, insertable components <NUM> can be slidably received within the slotted windows <NUM>.

Claim 1:
An ostomy appliance comprising:
a ring member (<NUM>, <NUM>) having an interior surface and an engagement portion (<NUM>) encircling a centrally-located input opening, wherein the engagement portion comprises a plurality of spaced-apart flexible tabs (<NUM>) extending radially inward into the input opening, the flexible tabs having opposing side edges and opposing interior and exterior surfaces (<NUM>, <NUM>) with an opening (<NUM>) extending therebetween, the opening being centrally located between the opposing side edges, a plurality of spaced-apart teeth (<NUM>) extending radially inward from the inside surface (<NUM>) of the ring member into the input opening, the teeth being in alignment in a first direction with spaces between the plurality of flexible tabs (<NUM>) and having an inside surface facing the interior surface (<NUM>) of the plurality of flexible tabs; and
a rib member (<NUM>) having a curved body portion (<NUM>) with opposing inside and outside surfaces (<NUM>, <NUM>) joined together by opposing top and bottom edges (<NUM>, <NUM>) and opposing side edges, the rib member having a dowel (<NUM>), pins (<NUM>) and a notched section (<NUM>) in the body portion, the dowel extending radially inward from the inside surface (<NUM>) of the body portion, the pins extending axially away from the top edge (<NUM>) of the body portion, the notched section forming a recess along the inside surface (<NUM>) and bottom edge (<NUM>) of the body portion,
wherein the rib member (<NUM>) is removably securable to the ring member whereby the pins of the rib member are insertable into openings (<NUM>) of adjacent flexible tabs of the plurality of flexible tabs (<NUM>) and a first tooth of the plurality of spaced-apart teeth (<NUM>) in alignment in the first direction with a space between the adjacent flexible tabs and is received within the notched section (<NUM>) of the rib member, the notched section being seated on the inside surface (<NUM>) of the tooth.