Dynamic Convex Ostomy Barrier

Abstract

A convex ostomy barrier assembly for attaching an Ostomy appliance to peristomal skin surrounding a stoma includes a skin barrier, an entrance opening defined in the skin barrier for receiving the stoma, and a convexity adjustment device, the convexity adjustment device including a convex insert and an inflatable bladder, the convex insert configured to provide a convexity to the skin barrier, and the inflatable bladder configured to adjust at least one characteristic of the convexity.

Description

[Technical Field]

[0001] The present disclosure relates to convex ostomy barriers. More particularly, the present disclosure relates to ostomy barrier devices having localized, adjustable convex features. [Background technology]

[0002] Ostomy pouches for collecting waste are used by individuals who have undergone surgery, such as a colostomy, ileostomy, or urostomy. Ostomy pouches may be attached to the user via an ostomy barrier, which is configured to seal against the peristomal skin surface and protect the peristomal surface from exposure to stoma output. However, the topography of the stoma and the peristomal surface around the stoma varies from patient to patient, and sealing the ostomy appliance against such different peristomal surfaces and stomas remains an area for further improvement. For example, the stoma may be more or less protruding, or may be flush or recessed.

[0003] Ostomy patients with flush or recessed stomas may find that applying external support or pressure from a barrier in the peristomal area helps direct stoma outflow directly into the ostomy pouch. This may extend the effectiveness of the adhesive seal between the ostomy barrier and the peristomal skin surface (i.e., the seal formed by the adhesive layer). Accordingly, convex inserts and convex ostomy barriers, such as the ADAPT® Convex Barrier Ring available through the present assignee, have been developed to apply pressure across such peristomal areas.

[0004] However, the convex portions of conventional convex ostomy barriers or inserts are fixed and may not function effectively for all ostomates. Therefore, convex ostomy barriers and convex inserts with various convex depths are available on the market. Furthermore, U.S. Patent Application Publication No. 2019 / 0231580, assigned to the present applicant and incorporated herein by reference, discloses an ostomy barrier appliance that includes a convexity adjustment device configured to allow a user to provide a convex portion to a substantially flat skin barrier.

[0005] It is therefore desirable to provide an improved ostomy barrier device that allows the various properties of the barrier projections to be locally tailored according to the topography of the user's stoma and peristomal surfaces. Summary of the Invention

[0006] According to various embodiments, a convexity adjustment device for an Ostomy skin barrier is provided that is configured to adjust the convexity of the skin barrier. In one aspect, a convex ostomy barrier assembly for attaching an Ostomy appliance to peristomal skin surrounding a stoma can include a skin barrier, an entrance opening defined in the skin barrier for receiving the stoma, and a convexity adjustment device. The convexity adjustment device can include a convex insert and an inflatable bladder, where the convex insert can be configured to provide a convexity in the skin barrier and the inflatable bladder can be configured to adjust at least one characteristic of the convexity.

[0007] In one embodiment, the inflatable bladder may be compartmentalized into multiple bladders, and the protrusion adjustment device may be configured to separately inflate or deflate each of the multiple bladders. The protrusion insert may include a base and an upper layer. The upper layer may extend from the base to the inner periphery, and the inflatable bladder may be disposed adjacent to a distal surface of the upper layer between the base and the upper layer. In such an embodiment, the inflatable bladder may be configured to locally adjust the compressibility and / or depth of the protrusion by inflating or deflating one or more of the multiple bladders.

[0008] In one embodiment, the ostomy barrier assembly may be provided with a plurality of bladders each inflated to provide a substantially uniform first compressibility around the ridge. In such an embodiment, one or more of the plurality of bladders may be deflated to adjust the first compressibility to a second compressibility at one or more corresponding locations to provide localized, customized adjustment of the compressibility of the ridge, the first compressibility being greater than the second compressibility. In other embodiments, the ostomy barrier assembly may be provided with a plurality of bladders each inflated to provide a substantially uniform third compressibility around the ridge. In such an embodiment, one or more of the plurality of bladders may be inflated to adjust the third compressibility to a fourth compressibility at one or more corresponding locations to provide localized, customized adjustment of the compressibility of the ridge, the third compressibility being less than the fourth compressibility.

[0009] In one embodiment, inflatable bladders may be disposed between the convex insert and the skin barrier, and each of the plurality of bladders may be configured to be separately inflated or deflated to provide localized, customized adjustment of the slope of the convex portion. In such an embodiment, the inflatable bladders may be disposed in the recesses of the convex insert. One or more of the plurality of bladders may be inflated to decrease the slope of the convex portion at one or more corresponding locations, or deflated to increase the slope of the convex portion at one or more corresponding locations.

[0010] In one embodiment, the convex ostomy barrier assembly may be provided with a plurality of bladders each filled with air to impart a substantially uniform slope around the periphery of the convex portion, and one or more of the plurality of bladders may be compressed or collapsed to increase the slope of the convex portion at one or more corresponding locations.

[0011] In one embodiment, an inflatable bladder may be disposed between the convex insert and the skin barrier within the dome region and configured to adjust the depth of the convexity. In such an embodiment, the convex ostomy barrier assembly may be provided with an inflatable bladder that is substantially deflated to provide a first depth, and the inflatable bladder may be configured to be inflated by a user to increase the depth to a second depth, the second depth being greater than the first depth. Alternatively, the convex ostomy barrier assembly may be provided with an inflatable bladder that is inflated to provide a third depth, and the inflatable bladder may be configured to be deflated by a user to decrease the depth to a fourth depth, the fourth depth being less than the third depth.

[0012] In one embodiment, an inflatable bladder may be disposed within the recess of the convex insert between the convex insert and the skin barrier and configured to adjust the slope of the convex portion. In such an embodiment, the convex ostomy barrier assembly may be provided with an inflatable bladder that is substantially deflated to provide a first slope, and the inflatable bladder may be configured to be inflated by a user to reduce the slope to a second slope, the second slope being less than the first slope. Alternatively, the convex ostomy barrier assembly may be provided with an inflatable bladder that is inflated to provide a third slope, and the inflatable bladder may be configured to be deflated by a user to increase the slope to a fourth slope, the fourth slope being greater than the third slope.

[0013] In one embodiment, the inflatable bladder may be positioned adjacent to the distal surface of the convex insert and configured to adjust the compressibility of the convex portion. The convex ostomy barrier assembly may be configured such that the compressibility of the convex portion can be adjusted by inflating or deflating the inflatable bladder while the depth and slope of the convex portion defined by the convex insert remain unchanged. For example, the inflatable bladder may be configured to be inflated to increase the compressibility of the convex portion and deflated to decrease the compressibility of the convex portion. In such an embodiment, the inflatable bladder may be positioned proximate the base region of the convex insert.

[0014] In any of the foregoing embodiments, the convex ostomy barrier assembly may include a fluid inlet and a fluid pathway connecting the fluid inlet to the inflatable bladder, wherein the fluid inlet and fluid pathway may provide a pathway for fluid to enter and exit the inflatable bladder. The inflatable bladder may be configured to be inflated by inserting a fluid into the inflatable bladder and deflated by releasing a fluid from the inflatable bladder. The fluid may be air.

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

[0016] Benefits and advantages of the present embodiments will become more readily apparent to those skilled in the art after reviewing the following detailed description and accompanying drawings. [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 1 is a distal perspective view of an ostomy barrier appliance, with portions removed to show its layered structure, according to one embodiment, including a ridge adjustment device with multiple bladders for localized, customized adjustment of ridge compressibility and / or depth. [Figure 2]FIG. 2 is a distal perspective view of an Ostomy barrier appliance including a ridge adjustment device with an inflatable bladder for customized adjustment of ridge depth, according to one embodiment, with portions removed to show its layered structure. [Figure 3A] 3A is a schematic cross-sectional view of the bulge adjustment device of FIG. 2 with the bladder deflated. [Figure 3B] 3B is a schematic cross-sectional view of the ridge adjustment device of FIG. 2 with the bladder inflated. [Figure 4A] FIG. 4A is a schematic cross-sectional view of a convexity adjusting device with an inflatable bladder for customized adjustment of convex slope according to another embodiment, in which the inflatable bladder is deflated. [Figure 4B] 4B is a schematic cross-sectional view of the ridge adjustment device of FIG. 4A with the inflatable bladder inflated. [Figure 5A] FIG. 5A is a schematic cross-sectional view of a protrusion adjustment device with an inflatable bladder for customized adjustment of compressibility according to yet another embodiment, with the inflatable bladder in a deflated state. [Figure 5B] 5B is a schematic cross-sectional view of the ridge adjustment device of FIG. 5A with the inflatable bladder inflated. [Figure 6] FIG. 6 is a distal perspective view of an ostomy barrier appliance including a convexity adjustment device with multiple bladders for localized, customized adjustment of convexity slope, according to one embodiment, with portions removed to show its layered structure. [Figure 7] FIG. 7 is an illustration of the depth of the convex skin barrier. [Figure 8] FIG. 8 is an illustration of the compressibility of a convex skin barrier. [Figure 9] FIG. 9 is an illustration of the flexibility of the convex skin barrier. [Figure 10A] FIG. 10A is an example of the tension position of a convex skin barrier. [Figure 10B] FIG. 10B is an example of the tension position of the convex skin barrier. [Figure 11] FIG. 11 is an example of the slope of the convex skin barrier. DETAILED DESCRIPTION OF THE INVENTION

[0018] While the present disclosure is susceptible of embodiments in various forms, the presently preferred embodiments are illustrated in the drawings and described below, with the understanding that the disclosure is to be considered as illustrative and is not intended to be limited to the particular embodiments illustrated. The words "a" or "an" should be construed to include both the singular and the plural. Conversely, reference to plural items shall include the singular where appropriate.

[0019] The characteristics of the convex portion of the skin barrier can include depth, compressibility, flexibility, tension position, and slope. See McNichol, L., Cobb, T., Depaifve, Y., Quigley, M., Smitka, K., & Gray, M., "Properties and Clinical Use of Convex Skin Barriers: Results of an International Consensus Panel," J Wound Ostomy Continence Nurs., (2021) 48(6), 524-532, Abstract. The depth of the convex skin barrier is defined as the distance from the apex of the dome to the base of the skin barrier, as described on page 526 of the same publication. Depth D can be measured as the size of the convex portion from the base located on the peristomal skin to the highest point of the skin barrier, as shown in Figure 7 of the same publication. As described in the same publication, when determining the depth of the convex skin barrier to achieve an optimal peristomal seal, careful consideration must be given to the individual user's peristomal conditions, such as the depth of peristomal wrinkles and folds.

[0020] The compressibility of a convex skin barrier is defined as the volume of the convex dome to be displaced or flattened, as shown in Figure 8 on page 528 of the same publication. Compressibility can be measured as the force required to displace or flatten the dome portion of the convex skin barrier a predetermined distance. As described therein, a soft convex barrier that is relatively easily compressible may better accommodate users with postoperative edema and / or a relatively stiff abdomen. As described therein, a stiff convex barrier that is relatively less compressible may apply more pressure to the peristomal skin to provide the necessary support for users with a relatively softer abdominal tone and / or wrinkles around the stoma.

[0021] As shown in Figure 9 on page 529 of the same publication, the flexibility of a convex skin barrier is defined as how easily the convex skin barrier can bend. As described therein, flexibility is an important property to consider when the skin barrier needs to bend to fit the contours of the abdomen. As described therein, a relatively flexible convex skin barrier may work well for users who have multiple wrinkles around the stoma due to loose skin.

[0022] The tension position of a convex skin barrier is known as the position where the convex dome exerts downward and outward forces on the peristomal topography, as shown in Figures 10A and 10B on page 530 of the same publication. As described therein, a convex skin barrier configured to apply tension near the stoma can provide a consistent and reliable seal around the stoma that is flush with the skin or pulled under the skin. As described therein, for users who have wrinkles and folds around the stoma, a convex skin barrier configured to apply tension away from the stoma can help flatten the peristomal skin to provide a good seal.

[0023] As shown in Figure 11 on page 53 of the same publication, the slope of the convex skin barrier is defined as the angle from the base of the dome to the circumference of the apex of the dome. Wrinkles and folds around the stoma can compromise the seal between the skin barrier and the skin. Adjusting the slope of the convex skin barrier according to the user's peristomal topography can improve the seal. For example, as described in the same publication, a convex skin barrier with a relatively small slope and a wider plateau can help flatten wrinkles and folds in the peristomal skin to achieve a good seal.

[0024] By customizing and adjusting the depth, compressibility, flexibility, tension position, and / or tilt of the convex skin barrier according to the user's peristomal topography, an optimal seal can be achieved around the stoma. The present disclosure provides ostomy barrier appliances including a convexity adjustment device configured to adjust one or more of the convexity characteristics of the skin barrier according to various embodiments.

[0025] Referring now to the figures, Figures 1-6 illustrate an ostomy barrier appliance according to some embodiments. Figure 1 is a perspective view of an ostomy barrier appliance 10 according to one embodiment, with portions removed from the pouch-facing side (also referred to herein as the distal side) to show the layered structure of the ostomy barrier appliance 10. The ostomy barrier appliance 10 may generally include a tape 12, a skin barrier 16, a protrusion adjustment device 14, and an entrance opening 18 for receiving a stoma (not shown). The protrusion adjustment device 14 may include an inflatable adjustment member 26 configured to adjust at least one characteristic of the protrusion of the ostomy barrier appliance 10.

[0026] Tape 12 may include a first adhesive layer and a first backing layer. The first adhesive layer of tape 12 may be formed from a suitable medical adhesive, such as an acrylic adhesive. The first backing layer may be formed from a suitable material, such as a nonwoven material or a thin polymer film. In other embodiments, tape 12 may include a hydrocolloid adhesive and a film backing layer.

[0027] In some embodiments, the skin barrier 16 may include a second backing layer laminated to the pouch-side surface of the skin barrier 16. The second backing layer may be formed from a suitable heat-sealable polymeric material such that the backing layer may be heat-sealed to the tape 12. The skin barrier 16 may also be formed from a suitable skin-contact adhesive, such as a hydrocolloid adhesive.

[0028] In one embodiment, the protrusion adjustment device 14 may be formed as a convex insert 14 including a base 22, an upper layer 20, and an inflatable adjustment member 26. The convex insert 14 may be configured to define and support the protrusion of the skin barrier 16. The upper layer 20 may extend from the base 22 to the inner periphery 32, and the inflatable bladder 26 may be disposed adjacent to the distal surface (pouch side) of the upper layer 20 between the base 22 and the upper layer 20.

[0029] 1, the inflatable bladder 26 may be compartmentalized into multiple bladders 27, each of which may be separately inflated or deflated to provide localized adjustment of the compressibility and / or depth of the convex portions of the ostomy barrier device 10. Each of the multiple bladders 27 may be separated from adjacent bladders by a sealing section 28 and may be inflated through the container 24.

[0030] In one embodiment, the ostomy barrier device 10 may be configured as a convex ostomy barrier including a dome 30 supported by a convex insert 14 containing inflatable bladders 26, each of which may be inflated to provide a substantially uniform initial compressibility and depth around the dome 30. In use, a user may deflate one or more of the bladders 27 according to the user's peristomal topography to reduce compressibility and / or depth in desired areas and create a seal that best suits the user's needs. Alternatively, the ostomy barrier device 10 may be provided with each of the multiple bladders 27 deflated or nearly deflated, and a user may inflate one or more of the multiple bladders 27 to increase compressibility and / or depth in desired areas. A user may inflate or deflate one or more of the multiple bladders 27 by inserting or expelling a fluid, such as air, in controlled amounts to achieve the desired compressibility and / or depth.

[0031] 2-6 illustrate some embodiments of ostomy barrier appliances 110, 210, 310, 410. The ostomy barrier appliances 110, 210, 310, 410 may be configured similarly to the ostomy barrier appliance 10 of FIG. 1 and may generally include a tape 12, a skin barrier 16, a protrusion adjustment device 114, 314, 414, 414, and an entrance opening 18 for receiving a stoma. The protrusion adjustment device 114, 214, 314 may include an inflatable bladder 126, 226, 326 that may be configured to adjust at least one characteristic of the protrusion of the ostomy barrier appliance 110, 210, 310.

[0032] FIG. 2 is a perspective view of an ostomy barrier appliance 110 according to one embodiment. The ostomy barrier appliance 110 may include a protrusion adjustment device 114 comprising a convex insert 122 and an inflatable bladder 126. In this embodiment, the inflatable bladder 126 may be positioned within the dome region 30 between the convex insert 122 and the skin barrier 16 to adjust the protrusion depth of the skin barrier 16. In one embodiment, the ostomy barrier appliance 110 may include a fluid pathway 128 configured to allow fluid, such as air, to enter and exit the inflatable bladder 126. FIG. 3A shows the inflatable bladder 126 substantially deflated, with the protrusion depth D of the ostomy barrier appliance 110 substantially defined by the depth of the convex insert 122. FIG. 3B shows the inflatable bladder 126 inflated to increase the protrusion depth D', with the inflated depth D' being greater than the deflated depth D. The inflatable bladder 26 may be configured to be inflated or deflated by inserting or expelling a volume of fluid to provide a desired depth of the protrusion of the ostomy barrier device 110 .

[0033] 4A and 4B are cross-sectional views of an ostomy barrier appliance 210 according to another embodiment. Similar to the protrusion adjustment device 114, the protrusion adjustment device 214 may include a convex insert 222 and an inflatable bladder 226. In this embodiment, the inflatable bladder 226 may be disposed between the convex insert 222 and the skin barrier 16 in a concave region 230 of the convex insert 222 to adjust the convex slope of the skin barrier 16. In FIG. 4A, the inflatable bladder 226 may be substantially deflated, and the convex portion of the ostomy barrier appliance 210, including the slope, is substantially defined by the convex portion of the convex insert 222. In FIG. 4B, the inflatable bladder 226 is inflated to reduce the slope. As shown, the slope of the convex barrier appliance 210 is less or shallower when the inflatable bladder 226 is inflated ( FIG. 4B ) than when the inflatable bladder 226 is deflated ( FIG. 4A ). The inflatable bladder 226 may be configured to be inflated or deflated by inserting or expelling a volume of fluid, such as air, to impart a desired slope to the convex portion of the ostomy barrier device 210 .

[0034] 5A and 5B are cross-sectional views of an ostomy barrier appliance 310 according to one embodiment. Similar to the protrusion adjustment devices 114, 214, the protrusion adjustment device 314 may include a convex insert 322 and an inflatable bladder 326. In this embodiment, the inflatable bladder 326 is positioned adjacent to the distal (pouch-side) surface of the convex insert 322 proximate the base region 330 and may be configured to adjust the compressibility of the convex portion of the skin barrier 16. In one embodiment, the ostomy barrier appliance 310 may be configured such that the compressibility can be adjusted by inflating or deflating the inflatable bladder 326, while the depth and slope of the convex portion defined by the convex insert 322 may remain unchanged. In other embodiments, the ostomy barrier appliance 310 may be configured such that the compressibility, depth, and / or slope of the convex portion defined by the convex insert 322 may be adjusted by inflating or deflating the inflatable bladder 326. In Figure 5A, the inflatable bladder 326 may be substantially contracted such that the compressibility of the ostomy barrier device 310 may be substantially determined by the compressibility of the convex insert 322. In Figure 5B, the inflatable bladder 326 may be inflated to increase the compressibility of the ostomy barrier device 310. The compressibility of the ostomy barrier device 310 may be greater or firmer when the inflatable bladder 326 is inflated compared to when the inflatable bladder 326 is deflated. The inflatable bladder 326 may be configured to be inflated or deflated by inserting or releasing a volume of fluid, such as air, to provide a desired compressibility of the convex portion of the ostomy barrier device 310.

[0035] FIG. 6 is a perspective view of an ostomy barrier device 410 according to one embodiment, viewed from the distal side with portions removed. The ostomy barrier device 410 may be configured similarly to the ostomy barrier device 210, which includes a convexity adjustment device 414 including a convex insert 422 and an inflatable bladder 426. The inflatable bladder 426 may be positioned between the convex insert 422 and the skin barrier 16, generally in a middle portion or recess 430 of the convex insert 422, and configured to adjust the convexity slope of the skin barrier 16. In this embodiment, the inflatable bladder 426 may include multiple bladders 427, each of which may be separately inflated or deflated to provide localized adjustment of the convexity slope. In use, a user may inflate one or more of the multiple bladders 427 to decrease the convexity slope or deflate one or more of the multiple bladders 427 to increase the convexity slope at a desired location. In one embodiment, the inflatable bladder 426 may include multiple pockets 427 filled with air. In use, a user may compress or collapse one or more of the plurality of air pockets 427 to increase the convex slope at a desired location around the ostomy barrier device 410 .

[0036] From the foregoing, it will be observed that numerous modifications and variations may be effected without departing from the true spirit and scope of the novel concepts of the present disclosure. It is understood that no limitation with respect to the particular embodiments illustrated is intended or should be inferred. The present disclosure is intended to cover, by the appended claims, all such modifications that fall within the scope of the claims.

Claims

1. 1. A convex ostomy barrier assembly for attaching an ostomy appliance to peristomal skin surrounding a stoma, comprising: a skin barrier comprising an adhesive; an entrance opening defined in the skin barrier for receiving the stoma; a protrusion adjustment device comprising a protrusion insert and an inflatable bladder; the convex insert is configured to provide a convex portion in the skin barrier, and the inflatable bladder is configured to adjust at least one characteristic of the convex portion. A convex ostomy barrier assembly, wherein the inflatable bladder is compartmentalized into a plurality of bladders, and the convexity adjustment device is configured to enable each of the plurality of bladders to be separately inflated or deflated.

2. A convex ostomy barrier assembly as described in claim 1, wherein the convex insert includes a base and an upper layer, the upper layer extending from the base to the inner circumference, the inflatable bladder positioned adjacent to the distal surface of the upper layer between the base and the upper layer, and the inflatable bladder configured to locally adjust the compressibility and / or depth of the convex portion by expanding or contracting one or more of the plurality of bladders.

3. A convex ostomy barrier assembly as described in claim 1 or claim 2, wherein the convex ostomy barrier assembly is provided with each of the plurality of bladders that is inflated to impart a substantially uniform first compressibility around the convex portion, and one or more of the plurality of bladders is contracted to adjust the first compressibility to a second compressibility at one or more of corresponding positions to provide localized, customized adjustment of the compressibility of the convex portion, the first compressibility being greater than the second compressibility.

4. A convex ostomy barrier assembly as described in claim 1 or claim 2, wherein the convex ostomy barrier assembly is provided with each of the plurality of bladders that is contracted to impart a substantially uniform third compressibility around the convex portion, and one or more of the plurality of bladders is inflated to adjust the third compressibility to a fourth compressibility at one or more of corresponding positions to provide localized, customized adjustment of the compressibility of the convex portion, the third compressibility being less than the fourth compressibility.

5. A convex ostomy barrier assembly as described in claim 1, wherein the inflatable bladders are positioned between the convex insert and the skin barrier, and each of the multiple bladders is configured to be inflated or deflated separately to provide localized, customized adjustment of the slope of the convex portion.

6. A convex ostomy barrier assembly as described in claim 5, wherein the inflatable bladder is positioned within a recess in the convex insert.

7. A convex ostomy barrier assembly as described in claim 5 or claim 6, wherein one or more of the plurality of bladders are inflated to reduce the slope of the convex portion at one or more corresponding positions.

8. A convex ostomy barrier assembly as described in claim 5 or claim 6, wherein one or more of the plurality of bladders are contracted to increase the slope of the convex portion at one or more corresponding positions.

9. A convex ostomy barrier assembly as described in claim 5 or claim 6, wherein the convex ostomy barrier assembly is provided with each of the plurality of bladders filled with air to impart a substantially uniform slope around the convex portion, and one or more of the plurality of bladders can be compressed or crushed to increase the slope of the convex portion at one or more corresponding positions.

10. A convex ostomy barrier assembly as described in claim 1, wherein the inflatable bladder is positioned between the convex insert and the skin barrier within a dome region and is configured to adjust the depth of the convex portion.

11. A convex ostomy barrier assembly as described in claim 10, wherein the convex ostomy barrier assembly is provided with an inflatable bladder that is substantially contracted to provide a first depth, and the inflatable bladder is configured to be inflated by a user to increase the depth to a second depth, the second depth being greater than the first depth.

12. A convex ostomy barrier assembly as described in claim 10, wherein the convex ostomy barrier assembly is provided with an inflatable bladder that is inflated to provide a third depth, and the inflatable bladder is configured to be deflated by a user to reduce the depth to a fourth depth, the fourth depth being less than the third depth.

13. A convex ostomy barrier assembly as described in claim 1, wherein the inflatable bladder is positioned within a recess in the convex insert between the convex insert and the skin barrier and is configured to adjust the inclination of the convex portion.

14. A convex ostomy barrier assembly as described in claim 13, wherein the convex ostomy barrier assembly is provided with an inflatable bladder that is substantially contracted to impart a first slope, and the inflatable bladder is configured to be inflated by a user to reduce the slope to a second slope, the second slope being less than the first slope.

15. A convex ostomy barrier assembly as described in claim 13, wherein the convex ostomy barrier assembly is provided with an inflatable bladder that is inflated to impart a third slope, and the inflatable bladder is configured to be deflated by a user to increase the slope to a fourth slope, the fourth slope being greater than the third slope.

16. A convex ostomy barrier assembly as described in claim 1, wherein the inflatable bladder is positioned adjacent to the distal surface of the convex insert and configured to adjust the compressibility of the convex portion.

17. A convex ostomy barrier assembly as described in claim 16, wherein the convex ostomy barrier assembly is configured so that the compressibility of the convex portion can be adjusted by expanding or contracting the inflatable bladder while the depth and slope of the convex portion defined by the convex insert remain unchanged.

18. A convex ostomy barrier assembly as described in claim 16 or claim 17, wherein the inflatable bladder is positioned adjacent to the base region of the convex insert.

19. A convex ostomy barrier assembly as described in claim 16, wherein the inflatable bladder is configured to be inflated to increase the compressibility of the convex portion and to be deflated to decrease the compressibility of the convex portion.

20. A convex ostomy barrier assembly as described in claim 1, wherein the convex ostomy barrier assembly includes a fluid inlet and a fluid path connecting the fluid inlet to the inflatable bladder, the fluid inlet and the fluid path providing a path for fluid to enter and exit the inflatable bladder.

21. A convex ostomy barrier assembly as described in claim 1, wherein the inflatable bladder is configured to be inflated by inserting a fluid into the inflatable bladder, and the inflatable bladder is configured to be deflated by releasing the fluid from the inflatable bladder.

22. A convex ostomy barrier assembly as described in claim 20, wherein the fluid is air.

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