WO2025259495A1

WO2025259495A1 - Concave barrier ring or strip

Info

Publication number: WO2025259495A1
Application number: PCT/US2025/032284
Authority: WO
Inventors: Walter R. Pedersen; Jesper R. WIKLANDER
Original assignee: Hollister Inc
Current assignee: Hollister Inc
Priority date: 2024-06-10
Filing date: 2025-06-04
Publication date: 2025-12-18
Anticipated expiration: 2026-12-10

Abstract

A concave ostomy barrier ring or strip is configured for positioning between an ostomy barrier and a user's peristomal skin. The ostomy barrier ring or strip is a ring or strip of a material having a first side and a second side. The first side has a concave profile, and the second side has a convex profile, a flat profile, or a concave profile.

Description

CONCAVE BARRIER RING OR STRIP

BACKGROUND

[0001] The present disclosure relates to a ring or strip for use with an ostomy appliance, and more particularly to a ring or strip for use in situations in which a concave surface facilitates effective use.

[0002] Ostomy pouches for collecting bodily waste are used by individuals who have had surgery such as a colostomy, ileostomy, or urostomy. Whether the user is using a one- piece pouch or a two-piece pouch, the ostomy pouch can be attached to a user via an ostomy barrier. The barrier is configured to seal against peristomal skin surfaces and protect the peristomal surfaces from exposure to stomal effluent. The barrier must effectively provide a seal around the entirety of the stoma.

[0003] 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 remains as an area for further improvement. For example, a stoma may protrude more or less, or may even be flush or recessed. Further, the user’s abdominal surface may have a challenging topography, having folds or other inconsistent or out of the ordinary features

[0004] The convexity of conventional convex ostomy barriers or inserts are fixed and may not work efficiently for all ostomates. That is, the conventional convex members may not allow for efficiently and effectively following a user’s abdominal contours thus allowing for a proper barrier seal.

[0005] Accordingly, it is desirable to provide an improved ostomy barrier appliance. Desirably such an appliance is a ring or strip that can be positioned between the ostomy barrier and the user’s peristomal skin. More desirably still such a barrier ring or strip can take various shapes to allow for conforming to the user’s peristomal skin topography.

BRIEF SUMMARY

[0006] In an aspect, an ostomy barrier accessory may be configured for positioning between an ostomy barrier and a user’s peristomal skin. The ostomy barrier accessory may have a first side and a second side, wherein the first side has a concave surface profile. The second side may have a convex surface profile, a flat surface profile, or a concave surface profile.

[0007] In an embodiment, the first side may have a concave surface profile and the second side may have a concave surface profile. In such an embodiment, the ostomy barrier accessory may have a varying thickness, wherein the thickness at outer end portions of the ostomy barrier accessory is greater than the thickness at a center portion.

[0008] In another embodiment, the first side may have a concave surface profile and the second side may have a convex surface profile. In such an embodiment, the ostomy barrier accessory may have a consistent thickness throughout the body of the ostomy barrier accessory.

[0009] In yet another embodiment, the first side may have a concave surface profile and the second side may have a flat surface profile. In such an embodiment, the ostomy barrier accessory may have a varying thickness, wherein the thickness at outer end portions of the ostomy barrier accessory is greater than the thickness at a center portion.

[0010] In any one of the foregoing embodiments, the ostomy barrier may be a convex barrier including a convex domed portion. In such embodiments, the first side of the ostomy barrier accessory may be configured to conform to the convex domed portion when the ostomy barrier accessory is positioned between the convex barrier and the user’s skin with the first side facing the convex barrier.

[0011] In any one of the foregoing embodiments, the ostomy barrier accessory may be a barrier strip having a generally rectangular body or a barrier ring having a ring-shaped body.

[0012] In any one of the foregoing embodiments, the ostomy barrier accessory may be formed from a hydrocolloid adhesive or a silicone adhesive. In some embodiments, the ostomy barrier accessory may be formed from a skin barrier material including at least one skin health ingredient, such as natural ceramide, synthetic ceramide or pseudo-ceramide. For example, the ostomy barrier accessory may be formed from a hydrocolloid adhesive including ceramide or pseudo-ceramide.

[0013] In an aspect, an ostomy barrier accessory may be formed from an ostomy barrier material and configured for positioning between an ostomy convex barrier and a user’s peristomal skin. The ostomy barrier accessory may comprise a first side having a concave surface profile and a second side having a concave surface profile, a flat surface profile or a convex profile. The ostomy barrier material may be a hydrocolloid adhesive or a silicon adhesive.

[0014] In some embodiments, the ostomy barrier accessory may be a barrier strip having a generally rectangular body or a barrier ring having a ring-shaped body.

[0015] The foregoing general description and the following detailed description are examples only and are not limiting of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] 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:

[0017] FIG. 1 is a perspective view of an example of a convex barrier showing the top or user-facing side of the barrier;

[0018] FIG. 2 is a perspective view of the convex barrier of FIG. 1 shown from bottom or pouch side of the barrier;

[0019] FIG. 3 is a schematic illustration of a convex barrier and a flat strip or ring;

[0020] FIG. 4 is a schematic illustration of a convex barrier and a strip or ring having a flat surface and a concave surface according to an embodiment;

[0021] FIG. 5 is a schematic illustration of a convex barrier and a strip or ring having a concave surface and a convex surface according to an embodiment;

[0022] FIG. 6 is a schematic illustration of a convex barrier and a strip or ring having double concave surfaces according to an embodiment;

[0023] FIG. 7 is a perspective view of a barrier ring according to an embodiment; and

[0024] FIG. 8 is a perspective view of a barrier strip according to an embodiment. DETAILED DESCRIPTION

[0025] 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.

[0026] The present disclosure provides a ring or strip that can be used with a convex ostomy barrier to provide an improved fit and seal between the barrier and the user’s peristomal skin according to various embodiments. One example of a conventional ostomy barrier 1 is illustrated in FIGS. 1 and 2, in which FIG. 1 is a view of the user-side 2 of the barrier 1 and FIG. 2 is a view of the pouch-side 3 of the barrier 1.

[0027] It will be appreciated when viewed from the user-side 2 of the barrier 1, the barrier 1 has a convex domed portion 4 that is positioned around the stoma to facilitate the stoma extending sufficiently toward or into the pouch to direct stomal discharge into the pouch. An opening 5 in the domed portion 4 is configured to receive the stoma. An adhesive A is present on the user-facing side 2 to adhere the barrier 1 to the user’s skin. FIG. 2 illustrates the pouch-facing side 3 of the barrier 1, an interior of the domed portion 4, and the opening 5 through which the stoma extends.

[0028] In a one-piece pouch system the pouch-facing side 3 of the barrier 1 may be attached to the pouch. In a two-piece pouch system, the pouch-facing side 3 of the barrier 1 may include a flange or like member that engages a cooperating member on the pouch to permit removing the pouch while the barrier 1 remains in place on the user.

[0029] As noted above, a user’s abdominal topography may be challenging, having folds or other inconsistent or out of the ordinary features. Referring to FIG. 3, a barrier ring or strip 6 is known that can be positioned between the barrier 1, for example, at the domed portion 4, and the user’s peristomal skin. Such known rings or strips 6 have flat surfaces and may help to apply pressure (or force) to the skin around the stoma. This urges the stoma to extend farther through the barrier opening 5 and into the interior of the domed portion 4. Extension of the stoma into the domed portion 4 in such a manner reduces the opportunity for leakage around the barrier 1. [0030] One issue with known flat rings or strips 6 is that they do not address issues with a user’s peristomal skin topography. Rather, because surfaces of the rings or strips 6 are flat, they may take on the shape of the barrier domed portion 4 only and may not necessarily conform to the user’s peristomal skin.

[0031] Referring now to FIGS. 4-6, there are shown various embodiments of concave barrier rings or strips. The ring or strip 10 in FIG. 4 may have a varying thickness indicated at 12 (thinner towards the center and thicker at the outer ends), a concave surface 14, and an opposite flat surface 16. The ring or strip 10 may be positioned between an ostomy barrier 1 and the user’s peristomal skin as appropriate. The concave surface 14 of the ring or strip 10 may be configured to conform to the convex domed portion 4 of the barrier 1. The ring or strip 10 may provide a flat surface 16 to conform to a user’s peristomal skin and further provide added force on the skin due to the thickness 12 of the ring or strip 10. The concave 14 surface applied to the convex domed barrier 4 may conform to the domed surface 4. The flat surface 16 can apply a greater force on the peristomal skin to extend a stoma farther into the barrier opening 5 to permit a “better” fit of the barrier 1, via the ring or strip 10, to the user’s skin’s unique topography and to reduce the opportunity for leakage around the barrier 1.

[0032] Referring to FIG. 5, a ring or strip 110 may have a consistent thickness 112, a concave surface 114 and an opposite convex surface 116. Again, the concave surface 114 may be configured to conform to the convex domed portion 4 of the barrier 1 and may be positioned between the domed portion 4 and the user’s peristomal skin. The ring or strip 110 may provide a convex surface 116 to conform to a user’s peristomal skin as appropriate, and may provide added force on the skin due to the thickness 112 of the ring or strip 110. The concave surface 114 applied to the convex domed barrier 4 may conform to the domed surface 4, while the convex 116 surface (similar to the barrier 4 profile) applies a greater force on the peristomal skin to extend a stoma farther into the barrier opening 5 to permit a “better” fit of the barrier 1 to the user’s skin’s topography to reduce the opportunity for leakage around the barrier 1.

[0033] FIG. 6 illustrates a ring or strip 210 that may have a varying thickness 212 (thinner towards the center and thicker at the outer ends), a concave surface 214 and an opposite concave surface 216. At least one of the dual concave surfaces 214, 216 of the ring or strip 210 may be configured to conform to the convex domed portion 4 of the barrier 1 and may be positioned between the domed portion 4 and the user’s peristomal skin. In an embodiment, the ring or strip 210 may provide a concave surface 214 to conform to the domed portion 4, and a concave surface 216 to conform to a user’s peristomal skin. In some embodiments, the surface curvature or degree of concavity of the concave surface 214 may be different than that of the concave surface 216. In other embodiments, the surface curvature or degree of concavity of the concave surface 214 and the concave surface 216 may be same. The ring or strip 210 may be configured to provide added force on the skin due to the thickness 212 of the ring or strip 210, while the concave surface 214 applied to the convex domed barrier 4 conforms to the domed surface 4, and the concave surface 216 conforms to the peristomal skin to permit a “better” fit of the barrier 1 to the user’s skin’s topography to reduce the opportunity for leakage around the ostomy barrier 1.

[0034] It is envisioned that all of the concave skin barrier ring or strip 10, 110, 210 embodiments may be formed from a material similar to the ostomy barrier 1 material to prevent leakage and to absorb dej ecta that may otherwise leak around the ostomy barrier 1. Such materials include, for example, known skin barrier materials and skin adhesives. In an embodiment, the barrier ring or strip 10, 110, 210 may be formed a hydrocolloid adhesive or a silicone adhesive. In some embodiments, the material for the barrier ring or strip 10, 110, 210 may include at least one skin health ingredient for improving skin health, such as natural or synthetic ceramides and pseudo-ceramides. For example, the barrier ring or strip 10, 110, 210 may be formed from a hydrocolloid adhesive containing ceramides.

[0035] All of the concave ring or strip 10, 110, 210 embodiments are configured to facilitate a better fit of a skin barrier 1 to a user’s skin. A concave ring or strip 10, 110, 210 of barrier or similar compatible material for use with known ostomy skin barriers also provides an additional absorbent sealant for the barrier. Although the present concave rings or strips 10, 110, 210 are described in use with convex skin barriers, it will be appreciated that the present concave rings or strips 10, 110, 210 will also function well and facilitate use in situations where the concave surface provides an effective fit with a flat ostomy barrier wafer.

[0036] It will be appreciated that each user’s peristomal skin topography is different and that a proper fit of the skin barrier 1 is necessary to proper functioning of the ostomy system. The present concave barrier rings or strips 10, 110, 210 allow for a better fit of the ostomy skin barrier 1 increasing the opportunity for ostomates to have an active lifestyle without worry or concern for ostomy appliance leakage or failure. The various concave rings and strips 10, 110, 210 embodiments that can be positioned between the ostomy barrier and the user’s peristomal skin can take various shapes to conform to the user’s peristomal skin topography. FIG. 7 shows a barrier ring 10, 110, 210 according to an embodiment, and FIG. 8 shows a barrier strip 10, 110, 210 according to an embodiment.

[0037] In the present disclosure the words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular. The words “first,” “second,” “third,” and the like may be used in the present disclosure to describe various information, such information should not be limited to these words. These words are only used to distinguish one category of information from another. The directional words such as, but not limited to, “upper” “lower” “raised” “lowered” “top” “bottom” “above” “below” “up” “down” “alongside” “front” “back” “left” and “right” and the like are used for purposes of illustration and as such, are not limiting. Depending on the context, the word “if’ as used herein may be interpreted as “when” or “upon” or “in response to determining.”

[0038] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present disclosure. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

CLAIMS What is claimed is:

1. An ostomy barrier accessory configured for positioning between an ostomy barrier and a user’s peristomal skin, the ostomy barrier accessory comprising a first side and a second side, wherein the first side has a concave surface profile.

2. The ostomy barrier accessory of claim 1, wherein the second side has a concave surface profile.

3. The ostomy barrier accessory of claim 2, wherein the ostomy barrier accessory has a varying thickness, wherein a thickness at outer end portions of the ostomy barrier accessory is greater than a thickness at a center portion of the ostomy barrier accessory.

4. The ostomy barrier accessory of claim 1, wherein the second side has a convex surface profile.

5. The ostomy barrier accessory of claim 4, wherein the ostomy barrier accessory has a consistent thickness.

6. The ostomy barrier accessory of claim 1, wherein the second side has a flat surface profile.

7. The ostomy barrier accessory of claim 6, wherein the ostomy barrier accessory has a varying thickness, wherein a thickness at outer end portions of the ostomy barrier accessory is greater than a thickness at a center portion of the ostomy barrier accessory.

8. The ostomy barrier accessory of any one of claims 1-7, wherein the ostomy barrier is a convex barrier including a convex domed portion, wherein the first side is configured to conform to the convex domed portion when the ostomy barrier accessory is positioned between the convex barrier and the user’s skin with the first side facing the convex barrier.

9. The ostomy barrier accessory of any one of claims 1-8, wherein the ostomy barrier accessory is a barrier strip having a generally rectangular body.

10. The ostomy barrier accessory of any one of claims 1-8, wherein the ostomy barrier accessory is a barrier ring having a ring-shaped body.

11. The ostomy barrier accessory of any one of claims 1-10, wherein the ostomy barrier accessory is formed from a hydrocolloid adhesive.

12. The ostomy barrier accessory of any one of claims 1-10, wherein the ostomy barrier accessory is formed from a silicon adhesive.

13. The ostomy barrier accessory of any one of claims 1-12, wherein the ostomy barrier accessory is formed from a skin barrier material including at least one skin health ingredient.

14. The ostomy barrier accessory of claiml3, wherein the at least one skin health ingredient includes a natural ceramide, a synthetic ceramide, or a pseudo- ceramide.

15. The ostomy barrier accessory of any one of claims 1-10, wherein the ostomy barrier accessory is formed from a hydrocolloid adhesive including a ceramide or a pseudo-ceramide.

16. An ostomy barrier accessory configured for positioning between an ostomy convex barrier and a user’s peristomal skin, comprising: a first side having a concave surface profile; and a second side having a concave surface profile, a flat surface profile or a convex profile; wherein the ostomy barrier accessory is formed from an ostomy barrier material.

17. The ostomy barrier accessory of claim 16, wherein the ostomy barrier material is a hydrocolloid adhesive.

18. The ostomy barrier accessory of claim 16, wherein the ostomy barrier material is a silicon adhesive.

19. The ostomy barrier accessory of any one of claims 16-18, wherein the ostomy barrier accessory is a barrier strip having a generally rectangular body or a barrier ring having a ring-shaped body.