Ostomy barrier device with self-actuating adjustable protrusions

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 configured to provide a convexity to the skin barrier and adjust said convexity according to the topography of the peristomal skin of a user when the convex ostomy barrier assembly is applied to the user. The convexity adjustment device is configured to provide a localized, customized adjustment of at least one characteristic of the convexity.

Description

[Technical field]

[0001] The present disclosure relates to a convex ostomy barrier. More particularly, the present disclosure relates to an ostomy barrier device having an adjustable convexity feature. [Background technology]

[0002] Ostomy pouches for collecting waste are used by individuals who have undergone surgery such as colostomy, ileostomy, or urinary stomy. Ostomy pouches may be attached to a user via an ostomy barrier configured to seal against the peristomal skin surface and protect the peristomal surface from exposure to stoma discharge. 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 individuals with flush or concave stomas may find that applying external support or pressure from a barrier in the peristomal area helps to direct the exit of stoma outflow directly into the ostomy pouch. Thus, the effectiveness of the adhesive seal between the ostomy barrier and the peristomal skin surface (i.e., the seal formed by the adhesive layer) may be extended. Thus, convex inserts and convex ostomy barriers, such as ADAPT® convex barrier rings available through the present applicant, have been developed to apply pressure across such peristomal areas.

[0004] However, the convexity of a conventional convex ostomy barrier or insert is fixed and may not work efficiently for all ostomates. Therefore, convex ostomy barriers and convex inserts with various convexity depths are available in the market. Furthermore, US Patent Application Publication No. 2019 / 0231580, which is assigned to the applicant of the present application and is incorporated herein by reference, discloses an ostomy barrier appliance including a convexity adjustment device configured to allow a user to adjust the convexity depth of the skin barrier. However, these ostomy barrier systems are configured to uniformly adjust the convexity depth only around the skin barrier and rely on the user's intervention to accurately select or adjust the convexity depth of the ostomy barrier.

[0005] It is therefore desirable to provide an improved Ostomy barrier appliance that requires minimal user intervention to tailor the various characteristics of the barrier protrusions 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 Ostomi skin barrier is provided that is configured to automatically adjust the convexity of the skin barrier.

[0007] In one aspect, a convex ostomy barrier assembly for attaching an Ostomy appliance to peristomal skin surrounding a stoma may include a skin barrier, an entrance opening defined in the skin barrier for receiving a stoma, and a convexity adjustment device. The convexity adjustment device may be configured to provide a convexity to the skin barrier and to automatically adjust the convexity according to the topography of the user's peristomal skin when the convex ostomy barrier assembly is applied to the user. The convexity adjustment device is configured to provide localized, customized adjustment of at least one characteristic of the convexity.

[0008] In one embodiment, the protrusion adjustment device may include a plurality of radially extending members configured to define and support a protrusion of the Ostomy barrier assembly. Each of the plurality of radially extending members may be separated from an adjacent radially extending member by a gap, and each of the radially extending members may be configured to bend independently according to a force applied to the radially extending member when the skin barrier is pressed against the peristomal skin of a user. Each of the radially extending members may be configured to automatically and locally adjust at least one of the slope, depth, compressibility, and tension position of the protrusion. The protrusion adjustment device may include a dome, a base, and an intermediate portion connecting the dome and the base, and the dome may be formed by the plurality of radially extending members.

[0009] In one embodiment, the protrusion adjustment device may be configured to have a depth of about 3 mm to about 15 mm and a slope of about 15° to about 80°. In another embodiment, the protrusion adjustment device may be configured to have a depth of about 7 mm to about 9 mm and a slope of about 55° to about 62° and may include 10 to 16 radially extending members, each of which may be separated by a gap having a width of about 2 mm to about 4 mm.

[0010] In one embodiment, the protrusion adjustment device may include a protrusion member and a plurality of beam members. The protrusion member may include a dome, a base, and an intermediate portion connecting the dome and the base. The plurality of beam members may extend radially from an edge of the dome to the base and may be configured to provide localized adjustment of the protrusion slope. Each of the plurality of beam members may be configured to bend independently and may include at least one hinge configured to facilitate bending of the beam members. The protrusion adjustment device may be configured with each of the plurality of beam members initially extended away from the intermediate portion, and each of the plurality of beam members may be configured to be pressed to bend independently when the skin barrier is pressed against the peristomal skin of the user to provide customized localized adjustment of the slope.

[0011] In one embodiment, the protrusion adjustment device comprises 36 beam members. In some embodiments, the middle portion may comprise a plurality of gaps, each of which may be disposed below a respective one of the beam members. The beam members may be integrally formed with the protrusion member as a single unit, or may be formed separately and attached to the protrusion member.

[0012] In one embodiment, each of the plurality of beam members may include a convex dome portion configured to match a convex body side contour of an adjacent dome region of the convex member.

[0013] In one embodiment, the protrusion adjustment device may include a mesh portion configured to automatically bend and mold to conform to the topography of the user's peristomal skin and to provide self-actuated and localized adjustment of the protrusion slope, depth, and / or tension position based on the amount of force applied to the mesh portion by the user's peristomal skin. In some embodiments, the mesh portion may be formed from a diamond pattern mesh. In other embodiments, the mesh portion may be formed from mesh having a variety of different patterns, such as circles, ellipses, squares, triangles, etc. In one embodiment, the protrusion adjustment device may include an inner edge, an outer edge, and a mesh portion extending radially between the inner edge and the outer edge.

[0014] In one embodiment, the protrusion adjustment device may include an inner edge, a base, and an intermediate portion extending therebetween. The intermediate portion may include a convex dome portion, a recess, and a plurality of openings and / or grooves. The plurality of openings and / or grooves may include a plurality of long openings and / or grooves extending radially in the convex dome portion and a plurality of short openings and / or grooves in the recess.

[0015] The plurality of openings and / or grooves may include an equal number of long openings and / or grooves and short openings and / or grooves, with each of the plurality of short openings and / or grooves aligned with one of the long openings and / or grooves to form a plurality of pairs of long openings / grooves and short openings / grooves. Each pair of long openings / grooves and short openings / grooves may extend radially and be spaced apart from an adjacent pair of long openings / grooves and short openings / grooves configured to facilitate bending and flexing of the convex ostomy barrier assembly along the pair of long openings / grooves and short openings / grooves. In some embodiments, each of the plurality of long openings and / or grooves may be defined by an opening that extends through the entire thickness of the convex adjusting device, and each of the plurality of short openings and / or grooves may be defined by a groove having a depth less than the thickness of the convex adjusting device, such that the groove does not extend through the entire thickness of the convex adjusting device.

[0016] The foregoing general description and the following detailed description are exemplary only and are not restrictive of the present disclosure. Other aspects, objects and advantages will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

[0017] 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 description of the drawings]

[0018] [Figure 1] FIG. 1 is a distal perspective view of an Ostomy barrier appliance including a ridge adjustment device according to one embodiment, with portions removed to show its layered structure. [Diagram 2] FIG. 2 is a partial enlarged view of the Ostomy barrier device of FIG. [Figure 3A] FIG. 3A is a perspective view of a main body side of a protrusion adjustment device according to an embodiment. [Figure 3B] 3B is a cross-sectional view of the protrusion adjusting device of FIG. 3A. [Figure 4]FIG. 4 is a distal perspective view of an Ostomy barrier appliance including a ridge adjustment device according to another embodiment, with portions removed to show its layered structure. [Diagram 5] FIG. 5 is a partial enlarged view of the Ostomy barrier device of FIG. [Figure 6] FIG. 6 is a distal perspective view of yet another embodiment of an Ostomy barrier appliance including a ridge adjustment device with portions removed to show its layered structure. [Figure 7] FIG. 7 is a partial enlarged view of the Ostomy barrier device of FIG. [Figure 8] FIG. 8 is a distal perspective view of an Ostomy barrier appliance including a ridge adjustment device according to one embodiment, with portions removed to show its layered structure. [Figure 9] FIG. 9 is a partial enlarged view of the Ostomy barrier device of FIG. [Figure 10] FIG. 10 is an illustration of the depth of a convex skin barrier. [Figure 11] FIG. 11 is an illustration of the compressibility of a convex skin barrier. [Figure 12] FIG. 12 is an illustration of the flexibility of a convex skin barrier. [Figure 13A] FIG. 13 is an illustration of the tension position of a convex skin barrier. [Figure 13B] FIG. 13B is an illustration of the tension position of a convex skin barrier. [Figure 14] FIG. 14 is an illustration of the slope of the convex skin barrier 13B. [Figure 15A] FIG. 15A is a perspective view of the main body side of the protrusion adjustment device according to the embodiment. [Figure 15B] 15B is a cross-sectional view of the protrusion adjusting device of FIG. 15A. [Figure 16A] FIG. 16A is a distal perspective view of a protrusion adjustment device according to one embodiment. [Figure 16B] 16B is a partial distal perspective view of the protuberance adjustment device of FIG. 16A. [Figure 17A] FIG. 17A is a perspective view of the main body side of the protrusion adjustment device according to the embodiment. [Figure 17B] 17B is a cross-sectional view of the protrusion adjusting device of FIG. 17A. [Figure 18A] FIG. 18A is a perspective view of the main body side of the protrusion adjustment device according to the embodiment. [Figure 18B] 18B is a cross-sectional view of the protrusion adjusting device of FIG. 18A. [Figure 19A] FIG. 19A is a perspective view of the main body side of the protrusion adjustment device according to the embodiment. [Figure 19B] 19B is a cross-sectional view of the protrusion adjusting device of FIG. 19A. [Figure 20] FIG. 20 is a perspective view of the main body side of the protrusion adjustment device according to the embodiment. [Figure 21] 21 is a distal perspective view of the protuberance adjustment device of FIG. 20. FIG. [Figure 22] FIG. 22 is a perspective view of the main body side of the protrusion adjustment device according to the embodiment. [Figure 23] 23 is a distal perspective view of the protuberance adjustment device of FIG. 22. FIG. [Figure 24] 24 is a partial cross-sectional view of the protrusion adjusting device of FIG. 22. FIG. [Diagram 25] FIG. 25 is a perspective view of the main body side of the protrusion adjustment device according to the embodiment. [Figure 26] 26 is a distal perspective view of the protuberance adjustment device of FIG. 25. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] While the present disclosure is susceptible of embodiment in various forms, it is understood that the disclosure is to be considered as illustrative and is not intended to limit the disclosure to the particular embodiments illustrated in the drawings and described below as presently preferred embodiments.

[0020] The characteristics of the convexity 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., Characteristics of Convex Skin Barriers and Clinical Application: 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, which is described on page 526 of the same book. The depth D can be measured as the size of the convexity from the base located on the peristomal skin to the highest point of the skin barrier, as shown in Figure 10 of the same book. As described therein, when determining the depth of the convex skin barrier to provide 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.

[0021] The compressibility of the convex skin barrier is defined as the volume of the convex dome to be displaced or flattened as shown in FIG. 11 on page 528 of the same publication. Compressibility may be measured as the force required to displace or flatten the dome portion of the convex skin barrier a given distance. As described in the same publication, a relatively easily compressible soft convex barrier may better accommodate users with post-operative edema and / or a relatively stiff abdomen. As described in the same publication, a relatively less compressible stiff convex barrier 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.

[0022] As shown in FIG. 12 on page 529 of the same publication, the flexibility of a convex skin barrier is defined as how much the convex skin barrier can bend easily. As described therein, flexibility is an important property to consider when the skin barrier needs to bend to conform to 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.

[0023] The tension position of the convex skin barrier is defined as the position where the convex dome exerts downward and outward force on the peristomal topography, as shown in Figures 13A and 13B 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 with 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.

[0024] As shown in FIG. 14 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 may compromise the seal between the skin barrier and the skin. By adjusting the slope of the convex skin barrier according to the user's peristomal topography, the seal can be improved. 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 of the peristomal skin to achieve a good seal.

[0025] By customizing and adjusting the depth, compressibility, flexibility, tension position, and / or tilt of the convex skin barrier according to the peristomal topography of the user, an optimal seal can be achieved around the stoma. The present disclosure provides an ostomy barrier appliance including a convexity adjustment device configured to automatically adjust one or more of the convexity characteristics of the skin barrier according to various embodiments. The convexity adjustment device may be configured as a self-actuating device that can automatically adjust and form according to the peristomal topography of the user when the ostomy barrier appliance is applied to the user.

[0026] Referring now to the drawings, Figures 1-2 show an ostomy barrier appliance 10 according to one embodiment. Figure 1 is a perspective view of the ostomy barrier appliance 10 with a portion 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 18, a protrusion adjustment device 14, and an entrance opening 16 for receiving a stoma. The protrusion adjustment device 14 may include radially extending members 20 separated by a gap 22, which may be configured to automatically adjust the protrusion of the ostomy barrier appliance 10 to provide a conformable seal without user interaction. The radially extending members 20 include an end 24 near the entrance opening 16. The protrusion adjustment device 14 may be attached to the distal side of the skin barrier 18 or may be provided as a protrusion insert that may be inserted into the ostomy barrier appliance 10.

[0027] 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 polymeric film. In other embodiments, tape 12 may include a hydrocolloid adhesive and a film backing layer.

[0028] In some embodiments, the skin barrier 18 may include a second backing layer laminated to the pouch side surface of the skin barrier 18. 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 18 may be formed from a suitable skin contact adhesive, such as a hydrocolloid adhesive.

[0029] In one embodiment, the protuberance adjustment device 14 may include a plurality of radially extending members 20, also referred to herein as petals. The plurality of petals 20 may be configured to define and support a protuberance of the skin barrier 18. Each of the plurality of petals 20 may be separated from an adjacent petal 20 by a gap 22, such that each petal 20 may be adjusted relatively independently of one another to allow localized adjustment of at least one characteristic of the protuberance of the ostomy barrier appliance 10 to better accommodate the peristomal region according to the peristomal topography. For example, the plurality of petals 20 may be configured to provide localized, customized adjustment of the slope, depth, and / or tension position of the convex skin barrier 18.

[0030] In one embodiment, the ostomy barrier appliance 10 may be configured as a convex ostomy barrier including a dome 19 supported by a plurality of petals 20, each of which may be formed to provide a uniform initial convex depth and slope around the dome 19, as shown in FIG. 1. In use, each of the plurality of petals 20 may be independently adjusted and shaped to conform to the peristomal topography of a user when the ostomy barrier appliance 10 is placed on the user. The convexity adjustment device 14 may be configured such that each of the plurality of petals 20 may be independently bent, compressed, and / or formed as the skin barrier 18 is pressed against the peristomal skin to provide a customized, localized convexity of the ostomy barrier appliance 10. FIG. 2 illustrates how one of the plurality of petals 20 may be pressed and flattened by a force applied in the direction indicated by the arrow, for example, as the petal 20 is pressed against a protruding portion of the peristomal skin (not shown). Additionally, a user may adjust the orientation of the Ostomi barrier device 10 so that one or more of the gaps 22 can be located across the axis where more flexibility is desired.

[0031] The protrusion adjustment device 14 may be formed from a suitable material, such as a polymeric material, rubber, silicone, or metallic material. For example, the protrusion adjustment device 14 may be formed from a heat-sealable thermoplastic material, such as ethylene vinyl acetate (EVA), a thermoplastic elastomer, or a thermoplastic urethane. In other examples, the protrusion adjustment device 14 may be formed from foam or silicone. The protrusion adjustment device 14 may be formed by thermoforming or other known methods.

[0032] 3A and 3B show a protrusion adjustment device 50 according to one embodiment. FIG. 3A is a perspective view of the protrusion adjustment device 50 from the main body side, and FIG. 3B is a cross-sectional view of the protrusion adjustment device 50. The protrusion adjustment device 50 may be configured similarly to the protrusion adjustment device 14 and may be attached to an ostomy barrier appliance 10 that generally includes a tape 12, a skin barrier 18, and an entrance opening 16 for receiving a stoma. The protrusion adjustment device 50 may include an outer portion 52 (also referred to herein as a base) and a dome 54 extending from the outer portion 52 and projecting toward the main body side. The dome 54 may be defined by a plurality of radially extending members 56, each of which may be separated by a gap 60 (also referred to herein as a slit). Each of the radially extending members 56 may include a peripheral end 58 proximate the entrance opening 16. In this embodiment, each of the gaps 60 may be defined by a generally V-shaped opening, and the width of the gap 60 may be greatest at a first end proximate the peripheral edge 58 and may decrease therefrom toward the end 62 of the gap 60, as best shown in FIG. 3A.

[0033] As best shown in FIG. 3B, the protrusion adjusting device 50 can include a concave body side 64 and a convex body side 66, with the dome 54 defined in the convex body side 66. The protrusion adjusting device 50 may be configured to have a protrusion depth D of about 3 mm to about 15 mm and a protrusion slope 0 of about 15° to about 80°. The protrusion slope 0 is the maximum slope measured at the body side of the protrusion adjusting device 50. In the embodiment of FIG. 3B, the protrusion slope 0 is measured at the transition point 68 between the concave body side 64 and the convex body side 66. In one embodiment, the protrusion adjusting device 50 may be configured to have a protrusion depth D of about 7 mm (FIG. 3B) including 16 radially extending members 56. The protrusion adjusting device 50 may be attached to the skin barrier 18 and / or the distal side of the tape 12. For example, the ridge adjustment device 50 may be heat sealed to the skin barrier 18 and / or tape 12 along inner diameter seal area A and outer diameter seal area B (FIG. 3B).

[0034] In another embodiment, the protrusion adjustment device 50' may be configured to have a protrusion depth D of about 7 mm including twelve radially extending members 56' as shown in Figures 15A and 15B.

[0035] In yet another embodiment, the protrusion adjustment device 50" may be configured to have a protrusion depth of approximately 9 mm including sixteen radially extending members 56", as shown in Figures 16A and 16B. The protrusion adjustment device 50" may be configured to have a protrusion slope of approximately 62°.

[0036] 20 and 21 show a protrusion adjustment device 150 according to one embodiment. FIG. 20 is a perspective view of the body side of the protrusion adjustment device 150, and FIG. 21 is a perspective view of the distal end of the protrusion adjustment device 150. The protrusion adjustment device 150 may be configured similarly to the protrusion adjustment devices 14, 50, and may be attached to an ostomy barrier appliance 10, which generally includes a tape 12, a skin barrier 18, and an entrance opening 16 for receiving a stoma. The protrusion adjustment device 150 may include an outer portion 152 (also referred to herein as a base) and a dome 154 extending from the base 152 and projecting toward the body side. The dome 154 may be defined by a plurality of radially extending members 156, Each of the plurality of radially extending members 156 may be separated by a gap 160. Each of the radially extending members 156 may include a peripheral end 158 proximate the inlet opening 16.'

[0037] In this embodiment, each of the gaps 160 may include a generally oval or rounded end 162, and the width of the gaps 160 may decrease from a first end proximate the circumferential end 158 toward the rounded end 162 and increase at the rounded end 162, as shown in Figures 20 and 21. The increased width of the gaps 160 at the rounded end 162 may improve the compressibility and / or flexibility of each of the radially extending members 156 when compared to the protrusion adjustment device 50 including a generally V-shaped gap 60. The base 152 may include extended side wings 164 and an opening 166 defined therein for engaging an Ostomy Belt coupling member (not shown).

[0038] The ridge adjustment devices 50, 50', 50'', 150 may be configured to operate similarly to the ridge adjustment device 14, and each of the radially extending members 56, 56', 56'', 156 may be independently adjusted and shaped to conform to the peristomal topography of a user when the ostomy barrier appliance 10 is worn by the user.

[0039] The protrusion adjustment device 50, 50', 50", 150 may include a base 52, 52', 52", 152 and a dome 54, 54', 54", 154. The dome 54, 54', 54", 154 may be defined by a plurality of radially extending members 56, 56', 56", 156, each of which may be separated by a gap 60, 60', 60", 160. Each of the radially extending members 56, 56', 56", 156 may include a peripheral end 58, 58', 58", 158 proximate the inlet opening 16.

[0040] 4 and 5 show an ostomy barrier appliance 110 according to one embodiment. The ostomy barrier appliance 110 may be configured similarly to the ostomy barrier appliance 10 of FIG. 1 and may generally include a tape 12, a skin barrier 18, a protrusion adjustment device 114, and an entrance opening 16 for receiving a stoma. The protrusion adjustment device 114 may include a protrusion member 118 and a plurality of beam members 120. The protrusion member 118 may include a base 122, a dome 124, and an intermediate portion 126. The protrusion member 118 may be attached distally to the skin barrier 18 and / or the tape 12 along an inner circumference 128 and an outer circumference 130. The plurality of beam members 120 are configured to extend radially between an edge of the dome 124 and the base 122 and may be configured for localized adjustment of the protrusion of the ostomy barrier appliance 10, for example, the protrusion slope. The plurality of beam members 120 may be formed integrally with the convex member 118 or may be formed separately and attached to the convex member 118 .

[0041] 4 and 5, the beam members 120 may be integrally formed with the convex member 118 as a single unit. The beam members 120 may be defined between cuts formed in the intermediate portion 126. Each of the beam members 120 may be extruded or extended away from the intermediate portion 126 to reduce the convex slope at the corresponding location, as shown in FIG. 4. In such an embodiment, the gaps 116 may be formed in the intermediate portion 126 below the beam members 120, as shown in FIG. 4.

[0042] The protrusion adjustment device 114 may be adapted to allow each of the beam members 120 to bend independently. In one embodiment, the protrusion adjustment device 114 may be configured with each of the beam members 120 initially extending away from the middle portion 126, as shown in FIG. 4. In use, each of the beam members 120 may be independently pressed and bent as the skin barrier 18 is pressed against the peristomal skin to provide a customized, localized adjustment of the protrusion slope. FIG. 5 shows one of the beam members 120 bent distally as the beam member 120 is pressed against a protruding portion of the peristomal skin (not shown), thereby providing a localized, customized increase in the protrusion slope according to the topography of the peristomal skin.

[0043] 6 and 7 show an ostomy barrier appliance 210 according to another embodiment. The ostomy barrier appliance 210 may be configured similarly to the ostomy barrier appliance 110 of FIG. 4 and may generally include a tape 12, a skin barrier 18, a protrusion adjusting device 214, and an entrance opening 16 for receiving a stoma. The protrusion adjusting device 214 may be configured similarly to the protrusion adjusting device 114 and may include a protrusion member 220 and a plurality of beam members 216, except that the protrusion member 220 does not include a gap in the middle portion 226. In this embodiment, the plurality of beam members 216 may be formed separately and attached to the protrusion member 220, as best shown in FIG. 7. Each of the beam members 216 may include a hinge 218 configured to facilitate bending of the beam members 216 when the ostomy barrier appliance 210 is applied to a user. The hinge 218 may be formed on a distal side proximate a center of the beam members 216 and / or on a body side. In one embodiment, hinge 218 may be formed on a body side of beam member 216 and another hinge may be formed on an opposite distal side from hinge 218 .

[0044] In one embodiment, the convex member 220 does not include a gap in the middle portion 226, and the convex member 220 can function as a cover to prevent fluids or other substances from entering the convex adjustment device 214 and coming into contact with the beam member 216. For example, when the convex adjustment device 214 is secured around the stoma, fluids or other substances may not enter the convex adjustment device 214 when the Ostomy bag is overfilled or lifted by the user, causing reflux into the Ostomy bag.

[0045] In one embodiment, the ridge adjustment device 214 may be configured to automatically adjust the ridge slope of the skin barrier 18 according to the peristomal topography when the ostomy barrier appliance 210 is secured around the stoma. The ridge adjustment device 214 may be configured to automatically regain its initial configuration when removed from around the stoma.

[0046] 17A and 17B show a protrusion adjusting device 114' according to one embodiment. FIG. 17A is a perspective view of the protrusion adjusting device 114' from the main body side, and FIG. 17B is a cross-sectional view of the protrusion adjusting device 114'. The protrusion adjusting device 114' may be configured similarly to the protrusion adjusting device 114 and may include a protrusion member 118' and a plurality of beam members 120'. The protrusion adjusting device 114' may be configured to provide a protrusion having a depth D of about 3 mm to about 15 mm, a protrusion tilt O of about 15° to about 80°, and a tension position radially spaced from the stoma about 1 mm to about 50 mm. In one embodiment, the protrusion member 118' may be configured to have a depth D of about 6 mm (FIG. 17B). The plurality of beam members 120' may include 36 beam members configured to support the skin barrier 18 without creating a ripple look or feel on the Ostomy barrier appliance while allowing for localized tilt adjustment.

[0047] 18A and 18B show a protrusion adjustment device 114'' according to one embodiment. FIG. 18A is a perspective view of the protrusion adjustment device 114'' from the body side, and FIG. 18B is a cross-sectional view of the protrusion adjustment device 114''. The protrusion adjustment device 114'' may be configured similarly to the protrusion adjustment device 114 and may include a protruding member 118'' and a plurality of beam members 120''. In this embodiment, each of the plurality of beam members 120'' may include a hinged zone 218''. The hinged zone 218'' may be formed adjacent to the center of each beam member 120'' on the body side, as shown in FIG. 18A and 18B. In other embodiments, the hinged zone 218'' may be formed on the distal side of each beam member 120'', or on both the distal side and the body side of the beam member 120''.

[0048] 22-24 illustrate a protrusion adjusting device 114''' according to one embodiment. FIG. 22 is a proximal perspective view of the protrusion adjusting device 114''', FIG. 23 is a distal perspective view of the protrusion adjusting device 114''', and FIG. 24 is a partial cross-sectional view of the protrusion adjusting device 114'''. The protrusion adjusting device 114''' may be configured similarly to the protrusion adjusting device 114'' and may include a protruding member 118''' and a plurality of beam members 120'''. Each of the plurality of beam members 120''' may include a hinged zone 218''' configured to facilitate bending of the beam member 120''' when the Ostomy barrier appliance is worn by a user. The hinged zone 218''' may be formed on the proximal and distal sides of each beam member 120''', as best shown in FIG. 24. In other embodiments, hinged zones 218''' may be formed only on the distal side of each beam member 120''', or may be formed only on the body side of beam members 120'''. In this embodiment, each of beam members 120''' includes a convex dome portion 132''' configured to generally match the convex body side contour of the convex member 118''' region of the adjacent dome 124'''.

[0049] 8 and 9 show an ostomy barrier appliance 310 according to one embodiment. The ostomy barrier appliance 310 may be configured similarly to the ostomy barrier appliance 10 of FIG. 1 and may generally include a tape 12, a skin barrier 18, a protuberance adjustment device 314, and an entrance opening 16 for receiving a stoma. The protuberance adjustment device 314 may include an inner edge 318, an outer edge 320, and a mesh portion 316 extending radially therebetween. The mesh portion 316 may include a mesh pattern configured to allow the protuberance adjustment device 314 to bend and mold according to the topography of the user's peristomal skin when the ostomy barrier appliance 310 is applied to a user. The protuberance adjustment device 314 may be configured to achieve localized, customized adjustment of the slope, depth, and / or tension position of the skin barrier 18 based on how a force is applied to the protuberance adjustment device 314 when the ostomy barrier appliance 310 is applied to a user. In one embodiment, the protrusion adjustment device 314 may be configured to provide a protrusion having a depth D of about 3 mm to about 15 mm, a protrusion slope of about 15° to about 80°, and a tension position radially spaced from the stoma about 1 mm to about 50 mm.

[0050] In one embodiment, the mesh portion 316 may be formed from a diamond pattern mesh configured to automatically adjust the convexity of the skin barrier 18 according to the user's peristomal topography when the ostomy barrier appliance 310 is secured around the stoma. The convexity adjustment device 314 may be configured to provide localized, customized changes in slope, flexibility, and / or depth of the skin barrier 18 based on the force applied by the user's skin topography. FIG. 9 shows the ostomy barrier appliance 310 being pushed proximate to its inner periphery in response to the force (indicated by the arrow) applied by the user's peristomal skin (not shown) when the ostomy barrier appliance 310 is attached to the user. In one embodiment, the convexity adjustment device 314 may not include an inner edge 318, as shown in FIG. 9. In such an embodiment, the inner periphery of the convexity adjustment device 314 may be defined by the inner periphery of the mesh portion 316 to provide greater flexibility for sealing around the stoma.

[0051] 19A and 19B show a protrusion adjusting device 314' according to one embodiment. FIG. 19A is a side view of the main body of the protrusion adjusting device 314', and FIG. 19B is a cross-sectional view of the protrusion adjusting device 314'. The protrusion adjusting device 314' may be configured similarly to the protrusion adjusting device 314 and may include a mesh portion 316', an inner edge 318', and an outer edge 320'. The protrusion adjusting device 314' is configured to provide a protrusion having a depth D of about 3 mm to about 15 mm, a protrusion slope O of about 15° to about 80°, and a tension position radially spaced from the stoma about 1 mm to about 50 mm. In one embodiment, the protrusion member 314' may be configured to have a depth D of about 7 mm (FIG. 19B).

[0052] 25 and 26 show a protrusion adjustment device 314″ according to one embodiment. FIG. 25 is a main body side view of the protrusion adjustment device 314″, and FIG. 26 is a distal side view of the protrusion adjustment device 314″. The protrusion adjustment device 314″ may be configured similarly to the protrusion adjustment device 314′ and may include an inner edge 318″ and an outer edge 320″ (also referred to herein as a base). In this embodiment, the protrusion adjustment device 314″ may include a middle portion with a plurality of openings and / or grooves 316″ instead of the mesh portion 316′. The plurality of openings and / or grooves 316″ may include a plurality of long openings and / or grooves 370″ extending radially in the convex dome portion 366″ and a plurality of short openings and / or grooves 372″ in the concave middle portion 364″ of the protrusion adjustment device 314″.

[0053] In one embodiment, the plurality of apertures and / or grooves 316" can include an equal number of long apertures and / or grooves 370" and short apertures and / or grooves 372", where each of the plurality of short apertures and / or grooves 372" can be aligned with a corresponding long aperture / groove 370", as shown in FIG. 25. In such an embodiment, each pair of long apertures / grooves 370" and short apertures / grooves 372" that extend radially away from an adjacent pair can be configured to facilitate bending and flexing of the ostomy barrier appliance including the protrusion adjustment device 314" along the pair of long apertures / grooves 370" and short apertures / grooves 372". In the embodiment of FIGS. 25 and 26, each of the plurality of long apertures / grooves 370" can be an aperture formed through the entire thickness. The protrusion adjustment device 314" and each of the plurality of short openings / grooves 372" may be formed as a groove having a depth less than the thickness of the protrusion adjustment device 314", such that the groove 372" does not extend through the entire thickness of the protrusion adjustment device 314". In some embodiments, the plurality of long openings and / or grooves 370" and the plurality of short openings and / or grooves may include only openings, only grooves, or a mixture of openings and grooves.

[0054] All patents referred to herein are incorporated herein by reference in their entirety, whether or not specifically indicated as such within the body of this disclosure.

[0055] In this disclosure, 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.

[0056] 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 to be understood that no limitation with respect to the specific 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 convexity adjustment device configured to provide a convexity to the skin barrier and to adjust the convexity according to the topography of a user's peristomal skin when the convex ostomy barrier assembly is applied to a user, the convexity adjustment device being configured to make localized, customized adjustments of at least one characteristic of the convexity.

2. 2. The convex ostomy barrier assembly of claim 1, wherein the protrusion adjustment device comprises a plurality of radially extending members configured to define and support the protrusions, each of the plurality of radially extending members separated from adjacent radially extending members by gaps, each of the radially extending members configured to bend independently in accordance with a force applied thereto when the skin barrier is pressed against the peristomal skin of the user, and each of the radially extending members configured to automatically and locally adjust at least one of the slope, depth, and / or tension position of the protrusions.

3. the protrusion adjustment device includes a dome, a base, and an intermediate portion connecting the dome and the base; The convex ostomy barrier assembly of claim 2 , wherein the dome is formed by the plurality of radially extending members.

4. 4. The convex ostomy barrier assembly of claim 3, wherein the convex adjustment device has a depth of about 7 mm, a slope of about 55°, and comprises twelve radially extending members.

5. 4. The convex ostomy barrier assembly of claim 3, wherein the convex adjustment device has a depth of about 7 mm to about 9 mm and a slope of about 55° to about 62°, and comprises sixteen radially extending members.

6. 2. The convex ostomy barrier assembly of claim 1, wherein the convex portion adjustment device comprises a convex member and a plurality of beam members, the convex member including a dome, a base, and an intermediate portion connecting the dome and the base, each of the plurality of beam members extending radially and configured to be independently bent to locally adjust the slope of the convex portion.

7. 7. The convex ostomy barrier assembly of claim 6, wherein each of the plurality of beam members comprises at least one hinge configured to facilitate bending of the beam member.

8. 8. The convex ostomy barrier assembly of claim 6 or claim 7, wherein the convex portion adjustment device is initially configured with each of the plurality of beam members extending away from the intermediate portion, and each of the plurality of beam members is configured to be pressed to independently bend as the skin barrier is pressed against the user's peristomal skin to provide customized, localized adjustment of the slope.

9. 8. The convex ostomy barrier assembly of claim 6 or claim 7, wherein the convexity adjustment device comprises 36 beam members.

10. 8. The convex ostomy barrier assembly of claim 6 or claim 7, wherein the intermediate portion comprises a plurality of gaps, each of the plurality of gaps being disposed below a respective one of the plurality of beam members.

11. 8. The convex ostomy barrier assembly of claim 6 or claim 7, wherein the intermediate section and the plurality of beam members are integrally formed as a single unit.

12. 8. The convex ostomy barrier assembly of claim 6 or claim 7, wherein the plurality of beam members are formed separately and attached to the intermediate section.

13. 7. The convex ostomy barrier assembly of claim 6, wherein each of the plurality of beam members includes a convex dome portion configured to match a convex body-side contour of an adjacent dome region of the convex member.

14. 2. The convex ostomy barrier assembly of claim 1, wherein the convex portion adjustment device comprises a mesh portion that automatically bends and shapes to conform to the topography of the user's peristomal skin and is configured to provide self-actuated and localized adjustment of the slope, depth, and / or tension position of the convex portion based on the amount of force applied to the mesh portion by the user's peristomal skin.

15. 15. The convex ostomy barrier assembly of claim 14, wherein the mesh portion is formed from a diamond pattern mesh.

16. 16. The convex ostomy barrier assembly of claim 14 or claim 15, wherein the mesh portion comprises mesh openings, the mesh openings near the entrance opening being smaller than the mesh openings further from the entrance opening.

17. 16. The convex ostomy barrier assembly of claim 14 or claim 15, wherein the convex adjustment device has a depth of about 7 mm and includes 120 mesh openings.

18. 16. The convex ostomy barrier assembly of claim 14 or claim 15, wherein the convex adjustment device includes an inner edge, an outer edge, and the mesh portion extending radially between the inner edge and the outer edge.

19. 2. The convex ostomy barrier assembly of claim 1, wherein the convex adjustment device comprises an inner edge, a base, and an intermediate portion extending between the inner edge and the base, the intermediate portion including a convex dome portion, a recess, and a plurality of openings and / or grooves, the plurality of openings and / or grooves including a plurality of long openings and / or grooves extending radially within the convex dome portion and a plurality of short openings and / or grooves within the recess.

20. 20. The convex ostomy barrier assembly of claim 19, wherein the plurality of openings and / or grooves comprises an equal number of the long openings and / or grooves and the short openings and / or grooves, each of the plurality of short openings and / or grooves being aligned with one of the long openings and / or grooves to form a plurality of pairs of long openings / grooves and short openings / grooves, each pair of long openings / grooves and short openings / grooves extending radially and spaced apart from an adjacent pair of long openings / grooves and short openings / grooves, and configured to facilitate bending and flexing of the convex ostomy barrier assembly along the pair of long openings / grooves and short openings / grooves.

21. 21. The convex ostomy barrier assembly of claim 19 or claim 20, wherein each of the plurality of long openings and / or grooves is an opening that extends through the entire thickness of the convex adjustment device, and each of the plurality of short openings and / or grooves is a groove that has a depth that is less than the thickness of the convex adjustment device, such that the groove does not extend through the entire thickness of the convex adjustment device.

22. 21. The convex ostomy barrier assembly of claim 19 or claim 20, wherein the protrusion adjustment device is configured to provide the protrusion with a depth of about 3 mm to about 15 mm, a slope of about 15° to about 80°, and a tension position radially spaced from the stoma about 1 mm to about 50 mm.

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