Ostomy barrier appliance including floating convex insert

Abstract

An ostomy barrier appliance for attaching an ostomy pouch appliance to a peristomal skin surrounding a stoma includes a skin barrier layer and a convex insert attached to a distal side of the skin barrier layer to define a convexity of the ostomy barrier appliance. The convex insert is attached to the skin barrier layer at a single attachment zone, such that the convex insert is substantially decoupled from the skin barrier layer. The ostomy barrier appliance is configured to allow convex insert to deform and conform to user's peristomal skin independently of the skin barrier layer when the ostomy barrier appliance is pressed against the user's peristomal skin, while the skin barrier layer remains attached to the user's peristomal skin.

Description

OSTOMY BARRIER APPLIANCE INCLUDING FLOATING CONVEX INSERTBACKGROUND

[0001] The following description relates to ostomy appliances, more particularly, adaptable convex ostomy barrier appliances.

[0002] Ostomy pouches for collecting bodily waste are used by individuals who have had surgery such as a colostomy, ileostomy, or urostomy. An ostomy pouch may be secured to a user via an ostomy barrier appliance that seals around the stoma and attached to the peristomal skin surface and protect the peristomal surface from exposure to stomal effluent. However, the topography of stomas and peristomal skin surfaces varies greatly among patients, and sealing an ostomy barrier appliance against such different peristomal skin surfaces and stomas remain as an area for further improvements. For example, a stoma may protrude more or less, or may even be flush or recessed.

[0003] Convex ostomy barrier appliances, such as a convex base plate including a convex insert, may be used in instances where the stoma is retracted or sunken into the user’s body. The convex base plate may apply pressure to the peristomal skin area surrounding the stoma in such a way that the stoma may project outward and be received through a stoma opening defined in the convex base plate. However, some conventional convex base plates can be relatively stiff, inflexible and do not conform to user’s body well, and thus, users often find them uncomfortable. Soft convex base plates have been developed to improve user comfort. US 2022 / 0370232, which is assigned to the Applicant of the present application and incorporated herein by reference, discloses convex ostomy barrier appliances having improved flexibility while maintaining compressibility sufficient to apply adequate pressure to user’s peristomal skin to protrude the stoma.

[0004] Convex ostomy barrier appliances that are configured to conform and adapt to user’s peristomal topography have also been developed. WO 2023 / 212537, which is assigned to the Applicant of the present application and incorporated herein by reference, discloses ostomy barrier appliances having self-activating adjustable convexity that are configured to provide localized and customized adjustments of at least one convexity characteristic of the barrier appliance. Further,U.S. Patent Application No. 63 / 597,163, which is assigned to the Applicant of the present application and incorporated herein by reference, discloses gentle and adjustable convex ostomy barrier appliances configured to allow convexity adjustment from a positive convexity depth to a negative convexity depth to conform to user’s peristomal topography.

[0005] Improvements in the adaptability of an ostomy convex barrier appliance to conform to various peristomal topographies can provide many benefits, such as minimizing a risk of ostomy effluent leakage and protecting user’s peristomal skin health. Thus, it is desirable to provide convex ostomy barrier appliances that can further improve the adaptability of ostomy barrier appliances.BRIEF SUMMARY

[0006] An ostomy barrier appliance configured to allow a convex insert to float within the ostomy barrier appliance and conform to user’s peristomal skin topography independently of a skin barrier layer is provided according to various embodiments.

[0007] In one aspect, an ostomy barrier appliance for attaching an ostomy pouch appliance to a peristomal skin surrounding a stoma may include a skin barrier layer, a convex insert attached to a distal side of the skin barrier layer to define a convexity of the ostomy barrier appliance, and an inlet opening for receiving the stoma. The skin barrier layer may include a skin barrier adhesive and a backing layer. The convex insert may be attached to the skin barrier layer at a single attachment zone, such that the convex insert is substantially decoupled from the skin barrier layer. The ostomy barrier appliance may be configured to allow convex insert to deform and conform to user’s peristomal skin independently of the skin barrier layer when the ostomy barrier appliance is pressed against the user’s peristomal skin, while the skin barrier layer remains attached to the user’s peristomal skin.

[0008] In an embodiment, the single attachment zone may be located proximate an outer periphery of the convex insert. The single attachment zone may be formed as a ring-shaped attachment zone having a width of about 0.5 mm to about 8 mm. The single attachment zone may be formed by heat sealing or other known sealing technologies.

[0009] In an embodiment, the backing layer may be formed from a polymeric material, and the ostomy barrier appliance may be configured to allow the convex insert to move and slide alongthe backing layer to adjust and conform to the user’s peristomal skin.

[0010] In some embodiments, the ostomy barrier appliance may include the convex insert configured to adjust the convexity from a first positive convexity depth to a second convexity depth as the ostomy barrier appliance is attached to the user’s peristomal skin. The second convexity depth may be a second positive convexity depth, a zero convexity depth, or a negative convexity depth. For example, the convex insert may be configured for a convexity depth adjustment from the first positive convexity depth of about 6 mm to the second convexity depth (D2), wherein -6 mm < D2 < 6 mm. In another example, the convex insert may be configured to provide a soft deep convexity having a convexity depth of about 15 mm. In yet another example, the convexity insert may be configured to have a depth of about 7.5 mm. The convexity depth is measured from a body side surface of a base of the convex insert to an apex of the convex insert. In an embodiment, the convex insert may be initially provided to have a first positive convexity depth and configured for a sectional convexity depth adjustment as the ostomy barrier appliance conforms to the user’s peristomal topography.

[0011] In an embodiment, the ostomy barrier appliance may include the convex insert configured for a convexity slope adjustment from about 50° to about -50°, wherein the convexity slope is a maximum slope measured on a body side surface of the convex insert. The convex insert may be configured to have a flexibility of about 20 N*mm to about 30 N*mm, wherein the flexibility is measured in energy expended to deform the convex insert by 30% according to the flexibility test method described hereinbelow. The convex insert may be configured to have a compressibility of about 5 N*mm to about 10 N*mm, wherein the compressibility is measured in energy expended to compress 3 mm of a convex dome of the convex insert according to the compressibility test method described hereinbelow.

[0012] In an embodiment, the ostomy barrier appliance may include the convex insert configured to have a convexity depth of about 6.5 mm to 7 mm, a convexity slope of about 50°, a flexibility of about 25 N*mm measured in energy expended to deform the convex insert by 30%, and a compressibility of about 7 N*mm measured in energy expended to compress 3 mm of a convex dome of the convex insert.

[0013] In an embodiment, the ostomy barrier appliance may include the convex insert comprising a plurality of radially extending members, wherein each of the plurality of radiallyextending members is separated from an adjacent radially extending member by a gap. Each of the radially extending members may be configured to be flexed independently according to a force applied to each of the radially extending member as the ostomy barrier appliance is pressed against the user’s peristomal skin.

[0014] In another embodiment, the ostomy barrier appliance may include the convex insert comprising a convex member and a plurality of beam members, wherein the convex member includes a convex dome, a base, and a middle portion connecting the convex dome and the base. In such an embodiment, each of the plurality of beam members may extend radially and configured to be flexed independently to provide a localized convexity adjustment.

[0015] In some embodiment, the ostomy barrier appliance may include the convex insert configured to have a ratio of a dome thickness to a hoop thickness of about 0.25: 1.0 to about 0.8: 1.0, wherein the dome thickness is a minimum cross sectional thickness of the convex insert in a convex dome portion, and the hoop thickness is a maximum cross sectional thickness of the convex insert in a concave body side portion.

[0016] In an embodiment, the ostomy barrier appliance may include the convex insert configured to have a pivot point proximate a base of the convex insert, wherein a dome and a middle portion of the convex insert are configured to surround a stoma when inverted to provide a funnel-like protection around the stoma.

[0017] In an embodiment, the ostomy barrier appliance may include the convex insert including a base and a convex dome, wherein the convex insert may be configured to have a depth of about 3 mm to about 10 mm, a convexity slope of about 15° to about 80°, a flexibility of about 5 N*mm to about 75 N*mm measured in energy expended to deform the convex insert by 30%, and a compressibility of about 5 N*mm to about 25 N*mm measured in energy expended to compress 3 mm of the convex dome of the convex. For example, the convex insert may be configured to have the depth of about 6 mm to about 7 mm, the convexity slope of about 55° to about 65°, the flexibility of about 15 N*mm to about 35 N*mm measured in energy expended to deform the convex insert by 30%, the compressibility of about 10 N*mm to about 15 N*mm measured in energy expended to compress 3 mm of the convex dome of the convex, and a ratio of dome thickness to hoop thickness of about 0.4: 1.0 to about 0.8: 1.0.

[0018] In any of the foregoing embodiments, the convex insert may be formed from ethylenevinyl acetate copolymer (EVA) having a modulus of about 7400 psi and durometer of about 90A. In some embodiments, the convex insert may be formed from a thermoplastic elastomer (TPE), polyurethane (PU), polyethylene (PE), polypropylene (PP), EVA or mixtures thereof. The skin barrier may include a hydrocolloid adhesive and / or a silicone adhesive.

[0019] The foregoing general description and the following detailed description are examples only and are not restrictive of the present disclosure. Other aspects, objectives and advantages will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0020] 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:

[0021] FIG. 1 is a perspective body side view of a convex ostomy barrier appliance according to an embodiment;

[0022] FIG. 2. is a perspective distal side view of the convex ostomy barrier appliance of FIG. 1;

[0023] FIG. 3 is an illustration of a depth of a convex barrier appliance;

[0024] FIG. 4 is an illustration of compressibility of a convex barrier appliance;

[0025] FIG. 5 is an illustration of flexibility of a convex barrier appliance;

[0026] FIGS. 6A and 6B are illustrations of tension locations of a convex barrier appliance;

[0027] FIG. 7 is an illustration of a slope of a convex barrier appliance;

[0028] FIGS. 8 A and 8B are schematic cross-sectional view of prior art ostomy barrier appliances;

[0029] FIG. 9 is a schematic cross-sectional view of an ostomy barrier appliance according to an embodiment;

[0030] FIG. 10A is a perspective distal side view of an ostomy barrier appliance with a portionremoved to illustrate its layered structure;

[0031] FIG. 10B is a schematic cross-sectional view of the ostomy barrier appliance of FIG.10 A;

[0032] FIG. 10C a schematic cross-sectional view of the ostomy barrier appliance of FIG. 10A conformed to a protruding peristomal topography;

[0033] FIG. 11 shows an example of a tensile testing machine configured to measure compressibility of a convex ostomy barrier appliance;

[0034] FIG. 12 is a perspective view of a base platen and an adapter for the tensile testing machine of FIG. 11 according to an embodiment;

[0035] FIG. 13 shows examples of differently sized securement plates for the tensile testing machine of FIG. 11;

[0036] FIG. 14 shows an example of a load cell for the tensile testing machine of FIG. 11 ;

[0037] FIG. 15 shows examples of differently sized platen inserts for the tensile testing machine of FIG. 11;

[0038] FIG. 16 shows examples of securement pins for the tensile testing machine of FIG. 11;

[0039] FIG. 17 shows an ostomy barrier appliance arranged on the tensile testing machine ofFIG. 11 during setup for a compressibility test according to an embodiment;

[0040] FIG. 18 is a side view of an ostomy barrier appliance arranged on the tensile testing machine of FIG. 11 during a compressibility test according to an embodiment;

[0041] FIG. 19 shows an example of a tensile testing machine configured to measure flexibility of an ostomy barrier appliance;

[0042] FIG. 20 shows an ostomy barrier appliance arranged in the tensile testing machine of FIG. 19 according to an embodiment;

[0043] FIG. 21 shows an example of an ostomy barrier appliance being prepared for a flexibility test according to an embodiment;

[0044] FIG. 22 shows another example of an ostomy barrier appliance being prepared for a flexibility test according to an embodiment;

[0045] FIG. 23 is a plan view showing an example of a trimmed ostomy barrier appliance for a flexibility test according to an embodiment;

[0046] FIG. 24 is an enlarged view of a positioning groove in the tensile testing machine ofFIG. 19 according to an embodiment;

[0047] FIG. 25 shows an example of an ostomy barrier appliance being positioned in the tensile testing machine of FIG. 19 for a flexibility test according to an embodiment;

[0048] FIG. 26 shows another example of an ostomy barrier appliance being positioned in the tensile testing machine of FIG. 19 for a flexibility test according to an embodiment;

[0049] FIG. 27 shows another example of an ostomy barrier appliance being positioned in the tensile testing machine of FIG. 19 for a flexibility test according to an embodiment;

[0050] FIG. 28 is a partial perspective view of the tensile testing machine of FIG. 19 with an ostomy barrier appliance arranged for a flexibility test according to an embodiment;

[0051] FIG. 29 shows an ostomy barrier appliance in an intended bending pattern during a flexibility test according to an embodiment;

[0052] FIG. 30 shows an ostomy barrier appliance in an unintended bending pattern during a flexibility test according to an embodiment;

[0053] FIG. 31A is a perspective body side view of a convex insert according to an embodiment;

[0054] FIG. 3 IB is a perspective distal side view of the convex insert of FIG. 31A;

[0055] FIG. 31C is a partial cross-sectional view of the convexity adjusting device of FIG. 31 A;

[0056] FIG. 32A is a perspective body side view of a convex insert according to another embodiment;

[0057] FIG. 32B is a perspective distal side view of the convex insert of FIG. 32A;

[0058] FIG. 32C is a partial cross-sectional view of the convex insert of FIG. 32A; and

[0059] FIGS. 33 A-D are schematic cross-sectional views of an ostomy barrier appliance according to an embodiment conforming to various peristomal topographies.DETAILED DESCRIPTION

[0060] 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.

[0061] FIGS. 1 and 2 show a convex ostomy barrier appliance 10 according to an embodiment. FIG. l is a perspective body side view, and FIG. 2 is a perspective distal side view of the convex ostomy barrier appliance 10. The ostomy barrier appliance 10 may be a base plate configured for detachable connection to an ostomy pouch (not shown). The ostomy barrier appliance 10 may include a skin barrier layer 12 for attachment to user’s peristomal skin and a convex insert 14 (also referred to herein as a convexity adjusting device) attached to a distal side of the skin barrier layer 12 to support and define a convex portion 15 and a convex body side contour 17 of the ostomy barrier appliance 10. The ostomy barrier appliance 10 may also include an outer flange 16 with an adhesive layer for attachment to user’s peristomal skin, and an inlet opening 18 (also referred to herein as a stoma opening) for receiving the stoma. The ostomy barrier appliance 10 may include a coupling member 20 on the pouch-facing side (also referred to herein as a distal side), to which an ostomy pouch appliance may be coupled. The inlet opening 18 may extend through the ostomy barrier appliance 10 from the body-facing side to the pouch-facing side. Accordingly, effluent from the stoma may be received in an ostomy pouch (not shown) connected to the ostomy barrier appliance 10.

[0062] Characteristics that define a convexity of an ostomy barrier appliance, such as a convex base plate, can include depth, compressibility, flexibility, tension location, and slope. See, McNichol, L., Cobb, T., Depaifve, K, 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 a convex skin barrier can be defined as a distance from the apex of a dome to a base of the convex skin barrier. Id, at pg. 526. The depth can be measured as a magnitude of a convexity from a base lying on the peristomal skin to the highest point of a convex skin barrier as shown in FIG. 3. Individual user’s peristomal condition, such as depths of creases and folds around the stoma, should be carefully considered when selecting a depth of a convex skin barrier to provide an optimal seal around the peristomal skin. Id.

[0063] The compressibility of a convex skin barrier can be defined as a capacity of a dome portion to be displaced or flattened as illustrated in FIG. 4. Id, at pg. 528. The compressibility may be measured as a force required to displace or flatten the dome portion of a convex skin barrier by a predetermined distance. A relatively easily compressible soft convex barrier may conform betterto users with postoperative edema and / or a relatively firm abdominal. Id. A relatively less compressible firm convex barrier may apply more pressure on the peristomal skin to provide support needed for users with a relatively soft abdominal tone and / or creases around the stoma. Id.

[0064] The flexibility of a convex skin barrier can be defined as how easily the convex skin barrier can bend, as illustrated in FIG. 5. Id, at pg. 529. The flexibility is an important characteristic to consider when a skin barrier needs to bend to conform to abdominal contours. Id. A relatively more flexible convex skin barrier may work well for users with multiple creases around stoma due to loose skin. Id.

[0065] The tension location of a convex skin barrier is defined as the position in which a convex dome exerts downward and outward forces on the peristomal topography, as illustrated in FIGS. 6A and 6B. Id, at pg. 530. A convex skin barrier configured to apply a tension close to a stoma may provide a consistent and reliable seal around the stoma that is flush to the skin or retraced below the skin. Id. For users with creases and folds around the stoma, a convex barrier skin barrier configured to apply a tension away from the stoma may help flatten the peristomal skin to provide a good seal. Id.

[0066] The slope of a convex skin barrier is defined as an angle from a base of the dome to a periphery of the apex of the dome, as illustrated in FIG. 7. Id, at pg. 53. Creases and folds around the stoma can compromise a seal between a skin barrier and the skin. Adjusting the slope of a convex skin barrier according to user’s peristomal topography can improve the seal. For example, a convex skin barrier with a relatively small slope and wider plateau may help flatten the peristomal skin creases and folds to achieve a good seal. Id.

[0067] FIGS. 8 A and 8B show schematic cross-sectional views of prior art ostomy barrier appliances 10*, 10**. The ostomy barrier appliances 10*, 10** generally includes a skin barrier layer 12*, 12** comprising a skin barrier adhesive for attachment to user’s peristomal skin and a convex insert 14*, 14**. Typically, the convex insert 14*, 14** in prior art ostomy barrier appliances is attached to the skin barrier layer 12*, 12**, such that the convex insert 14*, 14** and the skin barrier layer 12*, 12** stay together as a single unit when the ostomy barrier appliance is applied to user’s body. In FIGS. 8A and 8B, the skin barrier layer 12*, 12** and the convex insert 14*, 14** are shown with an exaggerated space therebetween for the purpose of illustratingand describing attachment zones 11 *, 11 **, 13*.

[0068] In the prior art ostomy barrier appliance 10* of FIG. 8A, the skin barrier layer 12* is attached to the convex insert 14* at two attachment zones 11*, 13*, which may be formed by heat sealing, an adhesive, or other known methods. Since the skin barrier layer 12* and the convex insert 14* are secured together proximate an outer periphery by a first attachment zone 11* and proximate an inner periphery by a second attachment zone 13*, the skin barrier layer 12* and the convex insert 14* remain as a single unit and move together when the ostomy barrier appliance 10* is pressed against and applied to user’s body.

[0069] In the prior art ostomy skin barrier appliance 10**, the skin barrier layer 12** is attached to the convex insert 14** along a single relatively long attachment zone 11** covering at least 50% of the surface area between the skin barrier layer 12** and the convex insert 14** as shown in FIG. 8B. As it was with the prior art ostomy barrier appliance 10*, the skin barrier layer 12** and the convex insert 14** of the ostomy barrier appliance 10** remain as a single unit and move together when the ostomy barrier appliance 10** is pressed against and applied to user’s body.

[0070] FIG. 9 shows a schematic cross-sectional view of an ostomy barrier appliance 10’ according to an embodiment of the present disclosure. The ostomy barrier appliances 10’ may generally include a skin barrier layer 12’ and a convex insert 14’. The skin barrier layer 12’ may include a backing layer 7’ and a skin barrier adhesive 9’ for attachment to user’s peristomal skin. The skin barrier layer 12’ may be attached to the convex insert 14’, such that the skin barrier layer 12’ and the convex insert 14’ are substantially decoupled to allow each member to move and adjust independently of each other as the ostomy barrier appliance 10’ is pressed against and applied to user’s body. Decoupling of the skin barrier layer 12’ from the convex insert 14’ may allow the skin barrier layer 12’ to maintain contact with user’s peristomal skin while the convex insert 14’ deforms, adjusts and conforms to the peristomal skin topography, thereby reducing shear force against the peristomal skin when compared to prior art ostomy barrier appliances, such as the ostomy barrier appliances 10*, 10**, that are configured such that the skin barrier layer and the convex insert are coupled together as a single unit.

[0071] In the embodiment of FIG. 9, the skin barrier layer 12’ may be attached to the convexinsert 14’ at a single attachment zone 11 ’ proximate an outer periphery. The attachment zone 11 ’ may be formed by heat sealing, an adhesive, or other known methods. The attachment zone 11 ’ may be formed as a ring-shaped attachment zone having a width W of about 0.5 mm to about 8 mm. The single attachment zone 11 ’ proximate an outer periphery may be configured to allow the convex insert 14’ to separate from the skin barrier layer 12’ and to float within the ostomy barrier appliance 10’, such that the convex insert 14’ may deform and adjust independently from the skin barrier layer 12’, while the skin barrier layer 12’ is attached to the peristomal skin to minimize shear force applied to the peristomal skin.

[0072] The ostomy barrier appliance 10’ may be configured to allow the convex insert 14’ to move and slide along the backing layer 7’ of the skin barrier layer 12’ as the convex insert 14’ flex and deform when the ostomy barrier appliance 10’ is pressed against the peristomal skin. In such an embodiment, the skin barrier layer 12’ and the convex insert 14’ may function as two separate members attached at an outer periphery and allow the convex insert 14’ to adapt and conform to the peristomal skin while moving and sliding long the backing layer 7’ of the skin barrier layer 12’ instead of pulling and forcing the skin barrier layer 12’ to move and deform with the convex insert 14’ as in the prior art ostomy barrier appliances 10*, 10**. The floating convex insert 14’ feature may allow the convex insert 14’ to conform to and redistribute its pressure against the peristomal skin more effectively, when compared to the prior art ostomy barrier appliances 10*, 10**, while minimizing shear force against the peristomal skin.

[0073] The floating convex insert 14’ feature may enhance the adaptability of soft convex ostomy barrier appliances, such as those disclosed in US 2022 / 0370232, self-adjusting convex ostomy barrier appliances, such as those disclosed in WO 2023 / 212537, and adjustable convex ostomy barrier appliances that are configured to allow convexity adjustment from a positive convexity depth to a negative convexity depth, such as those disclosed in U.S. Patent Application No. 63 / 597,163.

[0074] FIGS. lOAand 10B show an ostomy barrier appliance 300 according to an embodiment. In FIG. 10A, the ostomy barrier appliance 300 is shown with a portion removed and viewed from a pouch-facing side (also referred to herein as a distal side) to illustrate a layered construction of the ostomy barrier appliance 300. FIG. 10B is a schematic cross-sectional view of the ostomybarrier appliance 300. The ostomy barrier appliance 300 may generally include a tape 302, a skin barrier layer 312, a convex insert 314, and an inlet opening 318 for receiving a stoma. The tape 302 may include a substrate layer 304 (also referred to herein as a backing layer) and an adhesive layer 306. The convex insert 314 may be configured to adjust the convexity of the ostomy barrier appliance 300 according to user’s peristomal topography. The convex insert 314 may include radially extending members 320 separated by gaps 322, wherein each of the radially extending members may be configured to independently adjust the convexity of the ostomy barrier appliance 300 according to the respective peristomal topography.

[0075] In this embodiment, the skin barrier layer 312 may be attached to a body-side surface of the tape 302. The convex insert 314 may be attached to a distal surface of the substrate layer 304 of the tape 302 at a single attachment zone 311 proximate an outer periphery of the convex insert 314. Similar to the ostomy barrier appliances 10, 10’, the ostomy barrier appliance 300 may be configured to allow the convex insert 314 to float and slide along the substrate layer 304 of the tape 302 as the convex insert 304 flexes and adjusts when the ostomy barrier appliance 300 is pressed against the peristomal skin.

[0076] The ostomy barrier appliance 300 may be provided as a convex base plate having a positive convexity depth D, wherein a dome of the ostomy barrier appliance 300 (an inner portion proximate the inlet opening 318) protrudes toward a user when the ostomy barrier appliance 300 is placed adjacent the user as shown in FIGS. 10A and 10B. The ostomy barrier appliance 300 may be configured to allow adjustment of the convexity depth D from a positive depth (FIGS. 10A and 10B), wherein the dome protrudes toward a user, to a negative depth (FIG. 10C), wherein the dome is inverted and protrudes away from a user.

[0077] In an embodiment, the ostomy barrier appliance 300 may be initially provided as a convex base plate having a predetermined positive convexity depth D (FIG. 10B) and may be adjusted as the ostomy barrier appliance 300 is attached to a user to provide a different convexity depth D in at least one section according to the topography of user’s peristomal skin. For example, a user may have a protruding peristomal topography, and the ostomy barrier appliance 300 may be adjusted to provide a negative convexity depth D (FIG. 10C) to accommodate the protruding peristomal topography. In another example, a user may have a complex peristomal topography including a first section having a protruding peristomal topography, a second section having asunken depressed peristomal topography and a third section having a generally flat peristomal topography. For such a peristomal topography, the ostomy barrier appliance 300 may be adjusted to provide a first section having a negative convexity depth D corresponding to the protruding peristomal topography, a second section having a positive convexity depth D corresponding to the sunken depressed peristomal topography, and a third section having a generally zero convexity depth D corresponding to the generally flat peristomal topography.

[0078] FIGS. 33A-D show schematic cross-sectional views of the ostomy barrier appliance 300 conforming to various peristomal topographies according to an embodiment. In this embodiment, the convex insert 314 may be configured to have a pivot point 321 proximate a base 330, such that a dome 332 and a middle portion 334 may pivot at pivot point 321 as the convex insert 314 conforms to various peristomal topographies as shown in FIGS. 33A-34D.

[0079] FIG. 33 A shows the ostomy barrier appliance 300 in an initial state and arranged adjacent user’s peristomal skin 301. The ostomy barrier appliance 300 may be configured to have a positive convexity depth DI that protrudes toward user’s peristomal skin 301 in the initial state. As a user attaches the ostomy appliance 300 to the peristomal skin 301, pressure P may be applied to the dome 332 and / or middle portions 334. FIG. 33B shows the ostomy barrier appliance 300 being conformed to a sunken concave peristomal topography 301, wherein the dome 332 and middle portion 334 have been pressed down to provide a positive convexity depth D2 that is less than the positive convexity depth DI . The convex insert 314, which is attached to the skin barrier layer 312 at the single attachment zone 311, may deform independently of the skin barrier layer 312 to conform the peristomal topography, while the skin barrier layer 312 remains attached to the peristomal skin 301 as shown in FIG. 33B.

[0080] FIG. 33C shows the ostomy barrier appliance 300 being conformed to a generally flat peristomal topography 301’, wherein the dome 332 and middle portion 334 have been inverted to provide a negative convexity depth D3. FIG. 33 D shows the ostomy barrier 300 being conformed to a protruding peristomal topography 301”, wherein the dome 332 and middle portion 334 have been inverted to a maximum compression inversion state providing a negative convexity depth D4 greater than the negative convexity depth D3. The convex insert 314, which is attached to the skin barrier layer 312 at the single attachment zone 311, may deform and invert independently of theskin barrier layer 312 to conform the peristomal topography, while the skin barrier layer 312 remains attached to the peristomal skin 301” as shown in FIG. 33D. As shown in 34C and 34D, the convex insert 314 may be configured such that the dome 424 and middle portion 426 may provide a funnel or a cone-like protection around the stoma 402 when inverted. In such embodiments, the inverted dome 424 and middle portion 426 may facilitate flow of stoma effluent into an ostomy pouch and deter stoma effluent away from the peristomal skin.

[0081] The convex insert 14, 14’, 314 may be configured to have a convexity depth D, a convexity slope 0, flexibility, and compressibility characteristics to provide the convexity adjustment feature of the ostomy barrier appliance 300.

[0082] The compressibility of an ostomy barrier appliance, for example, the convex ostomy barrier appliance 10, 10’, 300 or the convex insert 14, 14’, 314 can be measured to quantify the “softness” of the ostomy barrier appliance. The compressibility may be measured as compression resistance values in a unit of energy, such as N*mm, calculated as an area under a force vs. displacement curve. To measure the compression resistance, a force may be applied to a convex portion of an ostomy barrier appliance with the ostomy barrier appliance laid flat on its pouchfacing side, and the energy expended to displace or compress the convex portion a predetermined distance is measured as a compression resistance value. The compression resistance values disclosed in the present disclosure are measured according to a test method described and referred to herein as compressibility test method, which measures a force to compress a convex portion of an ostomy barrier appliance a fixed distance. The test method is performed using a tensile testing machine, such as an MTS tensile testing machine.

[0083] FIG. 11 shows an example of a tensile testing machine 110 configured to perform the compressibility test method for measuring compression resistance of a convex ostomy barrier appliance. The tensile testing machine 110 may include a base platen 112 having an adapter 114, one or more securement plates 116 disposed on the base platen 112, a load cell 118, a platen insert 120 and one or more securement pins 122.

[0084] FIG. 12 is a perspective view of the base platen 112 and the adapter 114. The base platen 112 may include a plurality of fastening holes configured to receive corresponding fasteners 124. The fasteners 124 may be configured to attach the securement plate or plates 116 to the baseplaten 112. The fasteners 124 may be, for example, bolts, pins, or other known suitable fasteners or combinations of different fasteners. The base platen 124 may have a substantially flat, planar support surface 126. The adapter 114 may be configured to attach the base platen 112 to a base of the tensile testing machine 110.

[0085] FIG. 13 shows examples of differently sized securement plates 116 according to an embodiment. Each securement plate 116 may be a two-piece plate, with pieces being substantially mirror images of one another. For example, each securement plate 116 may include a first piece 128 and a second piece 130. Each piece 128, 130 may include one or more plate fastener holes 132 and a semi-circular opening 134. The securement plates 116 may be differently sized according to a diameter of the semi-circular openings 134. The semi-circular openings 134 may be sized to corresponds to different sizes of ostomy barrier appliances. For example, the semicircular openings 134 may correspond to the size (diameter) of a convex portion of the convex ostomy barrier appliance 10 or convex insert 14 to be tested. Accordingly, the securement plates 116 may be configured to constrain a radially outer portion of an ostomy barrier appliance, such as the outer flange 16 of the convex ostomy barrier appliance 10 or the base of the convex insert 14, without constraining the convex portion.

[0086] FIG. 14 shows an example of the load cell 118 according to an embodiment. The load cell 118, or load cell end effector, may be a top fixture on the tensile testing machine 110, i.e., mounted above the base platen 112, and configured to be moved toward the base platen 112 along a vertical axis during the compressibility test. The load cell 118 may have a width of 5 mm at a contact end 136 configured to compress the convex portion of an ostomy barrier appliance 10 during the compressibility test. The load cell 118 may be attached to the tensile testing machine 110 using two load cell fasteners 138 to maintain radial alignment.

[0087] FIG. 15 shows examples of differently sized platen inserts 120. Each platen insert 120 may include a plurality of platen insert fastener openings 140 and an opening 142. The opening 142 may be a circular opening, and the differently sized platen inserts 120 may be sized according to a diameter of the opening 142. Differently sized platen inserts 120, i.e., platen inserts 120 having differently sized openings 142 may be used for testing differently sized ostomy barrier appliances. In one embodiment, the openings 142 may be sized to receive a coupling flange of differently sizedostomy barrier appliances.

[0088] FIG. 16 shows examples of the securement pins 122. The securement pins 122 may be configured to secure the securement plate 116 to the platen insert 120. In one embodiment, four securement pins 122 may be used such that each of the first piece 128 and the second piece 130 of the securement plate 116 is fastened to the platen insert 120 using two securement pins 122. The securement pins 122 may extend into or through, for example, one or more platen insert fastener openings 140 and one or more aligned support plate fastener holes 132. Each securement pin 122 may include a shank 144 and a removable spring 146 on the shank 144 so that the securement springs 122 may accommodate different heights of ostomy barrier appliances.

[0089] FIG. 17 shows a convex ostomy barrier appliance 10 arranged on the tensile testing machine 110 during setup for the compressibility test according to an embodiment. A platen insert 120 may be selected based on the size of the convex ostomy barrier appliance 10 to be tested. The platen insert 120 may be disposed on / or attached to the base platen 112. The convex ostomy barrier appliance 10 may be positioned on the platen insert 120 such that the convex portion 15 is substantially aligned with and extends over or across the opening 142. The securement plate 116 may also be selected based on the size of the ostomy barrier appliance 10 to be tested. The first piece 128 of the securement plate 116 may be disposed over a portion of the outer flange 16. The semi-circular opening 134 of the first piece 128 may fit around a peripheral portion of the convex portion. Although not shown in FIG. 17, it is understood that the second piece 130 of the securement plate 116 may be disposed over another portion of the outer flange 16 and that the semi-circular opening 134 of the second piece 130 may fit around another peripheral portion of the convex portion. Accordingly, the convex portion on a body-facing side of the ostomy barrier appliance 10 may be exposed in the semi-circular openings 134. At least a portion of the outer flange 16 may be disposed between the first piece 128 and the platen insert 120 and the second piece 128 and the platen insert 120. In this manner, the ostomy barrier appliance 10 may be held for the compressibility test to be performed.

[0090] FIG. 18 is a side view of an ostomy barrier appliance 10 arranged on the tensile testing machine 110 during the compressibility test. In one embodiment, the first piece 128 and the second piece 130 of the securement plate 116 may be disposed over respective portions of the outerflange 16 of the ostomy barrier appliance. The first piece 128 and the second piece 130 may be connected to the platen insert 120 with the securement pins 122. The convex portion of the ostomy barrier appliance 10 may be disposed semi-circular openings 134 of the first piece 128 and the second piece 130, and thus, may be exposed. The contact end 136 of the load cell 118 may be moved into contact with the convex portion during the compressibility test.

[0091] The ostomy barrier appliance 10 may be prepared for the compressibility test by removing a release liner and replacing with a lint-free wipe, such as KIMWLPE, or similar. The ostomy barrier appliance 10 may be placed on the platen insert 120 in the manner described above. The securement plate 116 is configured to constrain a perimeter of the ostomy barrier appliance 10, e.g., the outer flange 16, around the convex portion without touching the convex portion, to mimic how the ostomy barrier appliance 10 would be constrained on a user. The load cell 118 may be lowered into contact with the convex portion to apply a preload of about 0.4 N.

[0092] The load cell 118 may be controlled to move at a rate of 5 inches per minute to compress the convex portion. The load cell 118 may be moved through a fixed displacement of 3.0 mm (about 0.118 in.). The tensile testing machine 110 may include, or be operably connected to, a computer configured to execute software for recording and / or calculating basic statistics during the compressibility test. For example, the tensile testing machine 110 may record, with the computer, the force applied at the load cell 118 at different displacements during the softness test method. The tensile testing machine 110, at the computer, may also determine other information, such as mean, minimum, maximum, standard deviation, and % coefficient of variance for record values. The tensile testing machine 110 may also calculate the energy from 0 to 1 mm displacement, 1 to 2 mm, and 2 to 3 mm (area under the force v. displacement curve). Further, the tensile testing machine 110 may calculate or record the compression force at 3 mm displacement and / or the compression distance at 5 N of force. It is understood that the computer for executing the software for recording and / or calculating may be part of the tensile testing machine 110 or a peripheral computing device operably connected to the tensile testing machine 110 or capable of receiving force and displacement information from the tensile testing machine 110.

[0093] The compressibility test may be performed on ostomy barrier appliances of different sizes. For example, the compressibility test may be performed on ostomy barrier applianceshaving 1 .75 in. coupling flange inner diameter, a 2.25 in. coupling flange inner diameter, and 2.75 in. coupling flange inner diameter (which also may be referred to as “small,” “medium” and “large” appliances in this disclosure). The compressibility test may be performed on convex inserts on their own or other 2-piece ostomy barrier appliances having a convex insert as well, which may vary in size from the examples above. In such instances, the tensile testing machine 110 and related components may be adapted as closely as possible in an effort to provide substantially similar testing environments so that test results may be reliably compared.

[0094] The flexibility of an ostomy barrier applicance may be quantified by measuring a bending resistance of the ostomy barrier appliance arranged vertically, i.e., with a diameter of the ostomy barrier appliance on a vertical axis, when a compressive force is applied to the ostomy barrier appliance on the vertical axis. The flexibility may be measured as a unit of energy, such as N*mm, calculated as an area under a force vs. displacement curve. That is, in the present disclosure, the flexibility may be measured as the energy expended to strain the ostomy barrier appliance by a predetermined amount. For example, flexibility may refer to the energy expended to deform the vertically arranged ostomy barrier appliance 10 by 30%, i.e., so that the height of the vertically arranged ostomy barrier appliance 10 is reduced by 30% by application of a compressive force.

[0095] FIGS. 19-30 are directed to a test method for testing flexibility of an ostomy barrier appliance, for example, the convex ostomy barrier appliance 10 or the convex insert 14, which is described and referred herein as the flexibility test method. FIG. 19 shows a portion of a tensile testing machine 210 for performing the flexibility test method according to an embodiment. The tensile testing machine 210 may include an upper platen 212 and a lower platen 214. An upper platen insert 216 may be attached to the upper platen 212. The lower platen insert 218 may be attached to the lower plate 218. The upper platen 212 may be moved toward the lower platen 214, or vice versa to perform the flexibility test method. The tensile testing machine 210 may include test works software or equivalent, or be operably coupled to a computing device having test works software or equivalent. The tensile testing machine 210 may provide a constant rate of traverse when one platen moves toward the other.

[0096] FIG. 20 shows an ostomy barrier appliance 10 arranged on the tensile testing machine 210 for performing the flexibility test. The ostomy barrier appliance 10 may be prepared such thatinjection-molded portions, for example, the coupling flange 22, are disposed in contact with the platen inserts 216, 218.

[0097] FIGS. 21 and 22 show examples of ostomy barrier appliances 10 being prepared for the flexibility test. In one embodiment, to prepare the ostomy barrier appliance 10 for the flexibility test, the outer flange 16 may be trimmed as indicated by the cut lines 220. In this manner, as noted above, an injection-molded portion, such as the coupling flange 22 or convex insert 14, may be disposed at or near edges of the ostomy barrier appliance 10 for the flexibility test. The ostomy barrier appliance 10 to be tested should be maintained flat during preparation to avoid bending or creasing.

[0098] FIG. 23 is a plan view of the ostomy barrier appliance 10 after trimming for the flexibility test. As shown in FIG. 23, the cut lines 220, and related trimming, results in two substantially parallel horizontal edges 222, extending tangentially to a 12 o’clock and a 6 o’clock position of the coupling flange 22. If the ostomy barrier appliance for the flexibility test is a one- piece product, the ostomy pouch may be removed from the sample for testing as well, for example, by cutting.

[0099] FIG. 24 is an enlarged view of a positioning groove 224, according to an embodiment. Each of the lower platen insert 216 and the upper platen insert 218 may include the positioning groove 224. The positioning groove 224 may include a first portion 226 having a first length and a second portion 228 having a second length. In one embodiment, the first length may be longer than a second length. In one embodiment the first portion 226 may a first slope and the second portion 228 may have a second slope. An absolute value of the first slope may be less than an absolute value of the second slope. The positioning slot 224 may have a width ‘w’ and a depth ‘d.’ A trough (i.e., a point of maximum depth) may be offset from center in the width ‘w’ direction. The first portion 226 may extend along a surface of the positioning groove 224 from the trough to one end of the positioning groove 224 in the width ‘w’ direction. The second portion 228 may extend along the surface of the positioning groove 224 from the trough to another, opposite end of the positioning groove 224 in the width ‘w’ direction. The positioning groove 224 may be sized and shaped to promote bending of the ostomy barrier appliance 10 in a predetermined direction during the flexibility test. For example, the size and shape of the positioning grooves 224 may promote bending of the ostomy barrier appliance to the right in FIG. 24.

[0100] FIGS. 25-27 show examples of the ostomy barrier appliance 10 being positioned in the tensile testing machine 210 for the flexibility test. As shown in FIG. 25, the trimmed, horizontal edges 222 may be arranged in respective positioning slots 224 of the upper and lower platen inserts 216, 218. In FIG. 26, a position of the ostomy barrier appliance 10 may be adjusted laterally relative to the upper and lower platen inserts 216, 218 such that a compressive force from the tensile testing machine 210 may applied at a consistent location on different ostomy barrier appliances for different flexibility tests. For example, the ostomy barrier appliance 10 may be substantially centered in a lateral direction of the upper and lower and platen inserts. Referring to FIGS. 26 and 27, the ostomy barrier appliance 10 may include first position markings 230 and second position markings 232. The first and second position markings 230, 232 may be at 0 and 180 degrees (12 o’clock and 6 o’clock), respectively. The upper and lower platen inserts 216, 218 may also include third and fourth position markings 234, 236, respectively. The ostomy barrier appliance 10 may be properly positioned relative the upper and the lower platen inserts 216, 218 when the first position marking 230 is substantially aligned with the third position marking 234, and the second position marking 232 is substantially aligned with the fourth position marking 236.

[0101] FIG. 28 is a perspective view of the tensile testing machine 210 having an ostomy barrier appliance 10 arranged for the flexibility test, according to an embodiment. As described above, the trimmed horizontal edges 222 of the ostomy barrier appliance 10 may be positioned in the respective positioning grooves 224 of the upper and lower platen inserts 216, 218. In one embodiment, a release liner may be removed from the convex portion 14 of the ostomy barrier appliance and a lint-free wipe may be disposed over the adhesive.

[0102] FIG. 29 shows the ostomy barrier appliance 10 in the tensile testing machine 210 during the flexibility test, bending in the desired manner for measuring flexibility, according to an embodiment. As shown in FIG. 29, a desired bending pattern for the ostomy barrier appliance 10 may include the coupling flange 22 bending toward the body-facing side of the ostomy barrier appliance 10 (or, to the right as shown in FIG. 29).

[0103] FIG. 30 shows an example of the ostomy barrier appliance 10 exhibiting an unintended bending pattern during the flexibility test. For example, an unintended bending pattern may include the coupling flange 22 bending toward the pouch-facing side (or, to the left as shown in FIG. 30). In such instances, measurements should not be recorded for determining flexibility ofthe ostomy barrier appliance 10.

[0104] The tensile testing machine 210 may be operated to apply a compressive force to the ostomy barrier appliance 10 arranged between the upper and lower platen inserts 216, 218 as described above, for example, by moving one of the platen inserts toward the other. A diameter or height of a functional part, e.g., the coupling flange 22 and / or convex insert 14 may be provided to the tensile testing machine 210. For example, the diameter or height may be provided to a computer having software to control operations of the tensile testing machine 210 to perform the flexibility test. The diameter or height may be measured, for example, with calipers or a ruler, and may refer to the distance between opposite edges of the coupling flange 22 and / or the convex insert 14. The diameter or height of each ostomy barrier appliance to be tested may be provided. The computer may be part of the tensile testing machine 210 or a peripheral device operably connected to the tensile testing machine.

[0105] Other information regarding the ostomy barrier appliance to be tested may be provided to the tensile testing machine 210 as well. For example, a groove depth and / or flexibility test parameters, such as initial speed, strain end point and data acquisition rate may be provided to the computer. In one embodiment, an initial speed (i.e., a speed of the platen providing the compressive force) may be approximately 10 in / min, the strain end point may be approximately 0.5 in / in and the data acquisition rate may be approximately 10.0 Hz.

[0106] In an embodiment, the tensile testing machine 210 may be operated to pre-load to the ostomy barrier appliance 10 to pre-bend the ostomy barrier appliance 10. The pre-bend may be defined in the software controlling the flexibility test and may, for example, have a default value of 2% of the diameter of the functional part of the ostomy barrier appliance 10.

[0107] The computer may record and / or calculate various parameters during the flexibility test. Calculations may be performed according to software executed by the computer, for example, software specific to the tensile testing machine 210. Example calculations include a pre-bend force at -2% strain (N) (static force measurement, useful to understand of the ostomy barrier appliance is properly arranged on the upper and lower platen inserts), energy at -30% strain (N*mm) (definite integral from 0 mm extension to 30% of the total functional part diameter or height as a function of load (N); alternatively, may be an “area under the curve” of the force measurement from extension = 0 mm to 30% of the total part height (mm)), and / or energy at -X% strain (N*mm)(same as above, but for alternative outputs of the test method if other strain % measurements are specified in a testing protocol). The flexibility data may be reported as the “energy at -30% strain” (N*mm) measurement. A minimum of three measurements may be taken per ostomy barrier appliance being tested. The first and second measurements may be discarded, and the third measurement may be reported as the flexibility measurement. In an embodiment, a load cell of the tensile testing machine 210 may be a 50N load cell. The flexibility test may be performed for ostomy barrier appliances of different sizes, such as the small, medium and large sizes described above. The flexibility test may be adapted for other ostomy barrier appliances having sizes different than those described above in an effort to obtain consistent results for reliable flexibility and / or compressibility comparisons.

[0108] Samples of the conves insert 14 that have the desired flexibility and compressibility balance were tested according to the compressiblity and flexibility test methods described above to quantify the convexity characteristics. For the compressibility characteristic, the compression resistance values based on the mean energy up to 3mm and the standard deviation were recorded. For the flexibility characteristic, energy at -30% strain of each convexity adjusting device sample was recorded. The “energy at -30% strain” as used herein is energy expended to deform a convexity adjusting device by 30%. Energy expended to deform an object by X% is the work done on the object to deform the object by X%, which is an “area under the curve” of the force measurement from extension = 0 mm to X% of the total object height (mm):

[0109] For the flexibility test, each convex insert sample was prepared and positioned in the tensile testing machine 210 according to the flexibility test method. A 50N load cell was used for the tensile testing machine 210. The settings used for the tensile testing machine were: initial speed (i.e., a speed of the platen providing the compressive force) - 10 in / min, strain end point - 0.5 in / in, and data acquisition rate - 10.0 Hz. Compressive force applied to a convex insert sample as the top platen moved down towards the bottom platen was recorded from the initial position of the ostomy barrier appliance sample (X=0) to -30% of the ostomy sample height (X=m). The area under the force measurement curve was calculated to obtain energy at -30% strain of the convesinsert sample.

[0110] FIGS. 31A-C show the convex insert 14’ according to an embodiment. As discussed above with regard to FIG. 9, the convex insert 14’ may be attached to the skin barrier layer 12’ at the single attachment zone 11 ’ proximate an outer periphery. FIG. 31 A is a perspective body side view of the convex insert 14’, FIG. 3 IB is a perspective distal side view of the convex inert 14’, and FIG. 31C is partial cross-sectional view of the convex insert 14’. The convex insert 14’ may be used in an ostomy barrier appliance, such as the convex ostomy barrier appliance 10, 10’, 300. The convex insert 14’ may include a base 22’, a dome 24’, and a middle portion 26’ connecting the base 22’ and the dome 24’. The dome 24’ may be defined by a plurality of radially extending members 28’, wherein each of the plurality of radially extending members 28’ may be separated by a gap 30’. Each of the radially extending members 28’ may include a peripheral end 32’ defining an inlet opening. The dome 24’ and the middle portion 26’ may extend from the base 22’ and protrude toward a body side direction such that the base 22’ and the dome 24’ are arranged in different planes.

[0111] In this embodiment, each of the gaps 30’ may include a generally oval shape or rounded end 34’, wherein a width of the gap 30’ may decrease from a first end proximate the peripheral end 32’ towards the rounded end 34’ and increase in the rounded end 34’ as shown in FIGS. 31A and 3 IB. The increased width of the gap 30’ in the rounded end 34’ may be configured to improve compressibility and / or flexibility of each of the radially extending member 28’ . The base 22’ may include extended side wings 36’ and openings 38’ defined therein for engaging with ostomy belt coupling members (not shown). In an embodiment, the the convex insert 14’ may be configured to include 10 radially extending members 28’.

[0112] The depth D of the convex insert 14’ is measured from a body side surface of the base 22’ to the apex of the convex insert 14’ as shown in FIG. 31C. The convexity slope 6 is a maximum slope measured on a body side surface of the convex insert 14’ . In the embodiment of FIG. 31C, the convexity slope Q is measured at a transition point 40’ between a concave body side surface 42’ and a convex body side surface 44’.

[0113] FIGS. 32A-32C show a convex insert 414 according to another embodiment. FIG. 32A is a perspective body side view of the convex insert 414, FIG. 32B is a perspective distal side view of the convex insert 414, and FIG. 32C is a partial cross-sectional view of the convex insert 414.The convex insert 414 may be used in an ostomy barrier appliance, such as the convex ostomy barrier appliance 10, 10’, 300, and may be attached to a skin barrier layer at a single attachment zone proximate an outer periphery similar to the foregoing embodiments. The convex insert 414 may be configured to have the similar convexity characteristics (e.g., depth, slope, compressibility, flexibility, and dome thickness to hoop thickness ratio) of the convex insert 14, 14’, 314 and may include a convex member 418, which has a similar cross sectional configuration as that of the convex insert 14, 14’, 314 and a plurality of beam members 420. The convex insert 414 may be configured such that each of the plurality of beam members 420 may be flexed independently. In an embodiment, the convex insert 414 may be initially configured with each of the plurality of beam members 420 extended away as shown in FIG. 32C. In use, each of the plurality of beam members 420 may be independently pressed to flex as the ostomy barrier appliance is pressed against the peristomal skin and the convexity is adjusted according to the corresponding topography of the peristomal skin. Further, the convex insert 414 may be configured for adjustment of a convexity depth D from a positive depth to a negative depth to conform to user’s peristomal topography.

[0114] Each of the plurality of beam members 420 may include a hinged zone 428 configured to facilitate flexing of the beam member 420. The hinged zone 428 may be formed on body side and distal side of each of the beam members 420 as best shown in FIG. 32C. In other embodiments, the hinged zone 428 may be formed only on the distal side of each of the beam members 420 or formed only on the body sides of the beam members 420. In this embodiment, each of the beam members 420 includes a convex dome portion 432 configured to generally match a convex body side contour of adjacent dome 424 areas of the convex member 418.

[0115] In an embodiment, the convex insert 14, 14’, 314, 414 may be configured to have an adjustable depth D range from about 14 mm to about -14 mm, preferably from about 8 mm to about -8 mm, more preferably from about 6 mm to about -6 mm, and an adjustable convexity slope 0 range from about 80° to about -80°, preferably about 65° to about -65°, more preferably about 50° to about -50°. The convex insert 14, 14’, 314, 414 may be configured to have a flexibility measured in energy expended to deform the convexity adjusting device by 30% according to the flexibility test method of about 0 N*mm to about 50 N*mm, preferably about 10 N*mm to about 40 N*mm, more preferably about 20 N*mm to about 30 N*mm, and compressibility measured inenergy expended to compress 3 mm of the convex portion of the soft convex inert according to the compressibility test method of about 0 N*mm to about 25 N*mm, preferably about 3 N*mm to about 15 N*mm, more preferably about 5 N*mm to about 10 N*mm. In such an embodiment, the convex insert 14, 14’, 314 may be configured to have a ratio of dome thickness 46’ to hoop thickness 48’ (FIG. 31C) of about 0.25: 1.0 to about 0.8: 1.0, preferably about 0.58: 1.0 to about 0.7: 1.0, and more preferably of about 0.6: 1.0. The dome thickness is a minimum cross sectional thickness of the convex insert 14, 14’, 314 in the convex body side portion 44’, and the hoop thickness is a maximum cross sectional thickness of the convex insert 14, 14’, 314 in the concave body side portion 42’.

[0116] In an embodiment, the convex insert 14, 14’, 314, 414 may be configured to have an intitial positive convexity depth D of about 6.5 mm to 7 mm, a convexity slope 0 of about 50°, flexibility measured in energy expended to deform the convexity adjusting device by 30% according to the flexibility test method of about 25 N*mm, compressibility measured in energy expended to compress 3 mm of the convex portion according to the compressibility test method of about 7 N*mm, and a ratio of dome thickness 46’ to hoop thickness 48’ of about 0.6: 1.0.

[0117] In an embodiment, the the convex insert 14, 14’, 314, 414 may be configured as a soft conves insert having a depth D of about 3 mm to about 10 mm, preferably about 5 mm to about 8 mm, more preferably about 6 mm to about 7 mm, a convexity slope 0 of about 15° to about 80°, preferably about 30° to about 70°, more preferably about 55° to about 65°, flexibility measured in energy expended to deform the soft convex insert by 30% according to the flexibility test method of about 5 N*mm to about 75 N*mm, preferably about 10 N*mm to about 50 N*mm, more preferably about 15 N*mm to about 35 N*mm, and compressibility measured in energy expended to compress 3 mm of the convex portion of the soft convex inert according to the compressibility test method of about 5 N*mm to about 25 N*mm, preferably about 8 N*mm to about 20 N*mm, more preferably about 10 N*mm to about 15 N*mm. In such an embodiment, the soft convex insert 14, 14’, 314 may be configured to have a ratio of dome thickness 46’ to hoop thickness 48’ of about 0.4: 1.0 to about 0.8: 1.0, preferably about 0.5: 1.0 to about 0.7: 1.0, and more preferably of about 0.6: 1.0. The dome thickness is a minimum cross sectional thickness of the soft convex insert 14, 14’, 314 in the convex body side portion 44’, and the hoop thickness is a maximum cross sectional thickness of the soft convex insert 14, 14’, 314 in the concave body side portion 42’.

[0118] In an embodiment, the soft convex insert 14, 14’, 314, 414 may be configured to have a depth D of about 6.5 mm to 7 mm, a convexity slope 0 of about 59°, flexibility measured in energy expended to deform the soft convex insert by 30% according to the flexibility test method of about 25 N*mm, compressibility measured in energy expended to compress 3 mm of the convex portion of the soft convex inert according to the compressibility test method of about 12 N*mm, and a ratio of dome thickness 46’ to hoop thickness 48’ of about 0.6: 1.0. For example, the soft convex insert 14, 14’, 314 may be configured to have a dome thickness 46’ of about 1.5 mm and a hoop thickness 48’ of about 2.5 mm.

[0119] The convex insert 14, 14’, 314, 414 may be formed from a suitable material, such as polymeric materials, rubber, silicone, or metallic materials. For example, the insert 14, 14’, 314, 414 may be formed from a heat sealable thermoplastic material, such as ethylene vinyl acetate (EVA) copolymer, thermoplastic elastomer, or thermoplastic urethane. In an embodiment, convex insert 14, 14’, 314, 414 may be formed from EVA copolymer having a modulus of about 7400 psi and durometer of about 90A, such as ELVAX™450 available from Dow.

[0120] All patents referred to herein, are hereby incorporated herein in their entirety, by reference, whether or not specifically indicated as such within the text of this disclosure.

[0121] 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.

[0122] 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

CLAIMSWhat is claimed is:

1. An ostomy barrier appliance for attaching an ostomy pouch appliance to a peristomal skin surrounding a stoma, comprising: a skin barrier layer comprising a skin barrier adhesive and a backing layer; a convex insert attached to a distal side of the skin barrier layer to define a convexity of the ostomy barrier appliance; and an inlet opening for receiving the stoma; and wherein the convex insert is attached to the skin barrier layer at a single attachment zone, such that the convex insert is substantially decoupled from the skin barrier layer, wherein the ostomy barrier appliance is configured to allow convex insert to deform and conform to user’s peristomal skin independently of the skin barrier layer when the ostomy barrier appliance is pressed against the user’s peristomal skin, while the skin barrier layer remains attached to the user’s peristomal skin.

2. The ostomy barrier appliance of claim 1, wherein the single attachment zone is located proximate an outer periphery of the convex insert.

3. The ostomy barrier appliance of claim 1 or 2, wherein the single attachment zone is formed as a ring-shaped attachment zone having a width of about 0.5 mm to about 8 mm.

4. The ostomy barrier appliance of any one of claims 1-3, wherein the backing layer is formed from a polymeric material, wherein the ostomy barrier appliance is configured to allow the convex insert to move and slide along the backing layer to adjust and conform to the user’s peristomal skin.

5. The ostomy barrier appliance of any one of claims 1-4, wherein the single attachment zone is formed by heat sealing.

6. The ostomy barrier appliance of any one of claims 1-5, wherein the convex insert is configured to adjust the convexity of the ostomy barrier appliance from a first positive convexity depth to a second convexity depth as the ostomy barrier appliance is attached to the user’s peristomal skin, wherein the second convexity depth is a second positive convexity depth, a zero convexity depth, or a negative convexity depth.

7. The ostomy barrier appliance of any one of claims 1-6, wherein the convex insert is initially provided to have a first positive convexity depth and configured for a sectional convexity depth adjustment as the ostomy barrier appliance conforms to the user’s peristomal topography.

8. The ostomy barrier appliance of claim 6 or claim 7, wherein the convex insert is configured for the convexity depth adjustment from the first positive convexity depth of about 6 mm to the second convexity depth (D2), wherein -6 mm < D2 < 6 mm, wherein the convexity depth is measured from a body side surface of a base of the convex insert to an apex of the convex insert.

9. The ostomy barrier appliance of any one of claims 1-8, wherein the convex insert is configured for a convexity slope adjustment from about 50° to about -50°, wherein the convexity slope is a maximum slope measured on a body side surface of the convex insert.

10. The ostomy barrier appliance of any one of claims 1-9, wherein the convex insert is configured to have a flexibility of about 20 N*mm to about 30 N*mm, wherein the flexibility is measured in energy expended to deform the convex insert by 30% according to the flexibility test method.

11. The ostomy barrier appliance of any one of claims 1-10, wherein the convex insert is configured to have a compressibility of about 5 N*mm to about 10 N*mm, wherein the compressibility is measured in energy expended to compress 3 mm of a convex dome of the convexinsert according to the compressibility test method.

12. The ostomy barrier appliance of any one of claims 1-11, wherein the convex insert is configured to have a convexity depth of about 6.5 mm to 7 mm, wherein the convexity depth is measured from a body side surface of a base of the convex insert to an apex of the convex insert, and a convexity slope of about 50°, wherein the convexity slope is a maximum slope measured on the body side surface of the convex insert, and a flexibility of about 25 N*mm, wherein the flexibility is measured in energy expended to deform the convex insert by 30% according to the flexibility test method, and a compressibility of about 7 N*mm, wherein the compressibility is measured in energy expended to compress 3 mm of a convex dome of the convex insert according to the compressibility test method.

13. The ostomy barrier appliance of any one of claims 1-12, wherein the convex insert comprises a plurality of radially extending members, wherein each of the plurality of radially extending members is separated from an adjacent radially extending member by a gap, wherein each of the radially extending members is configured to be flexed independently according to a force applied to each of the radially extending member as the ostomy barrier appliance is pressed against the user’s peristomal skin.

14. The ostomy barrier appliance of any one of claim 1-12, wherein the convex insert comprises a convex member and a plurality of beam members, wherein the convex member includes a convex dome, a base, and a middle portion connecting the convex dome and the base, wherein each of the plurality of beam members extends radially and configured to be flexed independently to provide a localized convexity adjustment.

15. The ostomy barrier appliance of any one of claims 1-14, wherein the convex insert is configured to have a ratio of a dome thickness to a hoop thickness of about 0.25: 1.0 to about 0.8: 1.0, wherein the dome thickness is a minimum cross sectional thickness of the convex insert in a convex dome portion, and the hoop thickness is a maximum cross sectional thickness of theconvex insert in a concave body side portion.

16. The ostomy barrier appliance of any one of claims 1-15, wherein the convex insert is configured to have a pivot point proximate a base of the convex insert, wherein a dome and a middle portion of the convex insert are configured to surround a stoma when inverted to provide a funnel-like protection around the stoma.

17. The ostomy barrier appliance of any of claims 1-5, wherein the convex insert includes a base and a convex dome, wherein the convex insert is configured to have a depth of about 3 mm to about 10 mm, a convexity slope of about 15° to about 80°, a flexibility of about 5 N*mm to about 75 N*mm, and a compressibility of about 5 N*mm to about 25 N*mm, wherein the depth is measured from a body side surface of the base to an apex of the convex insert, wherein the convexity slope is a maximum slope measured on the body side surface of the convex insert, wherein the flexibility is measured in energy expended to deform the convex insert by 30% according to the flexibility test method, and the compressibility is measured in energy expended to compress 3 mm of the convex dome of the convex inert according to the compressibility test method.

18. The ostomy barrier appliance of claim 17, wherein the convex insert is configured to have the depth of about 6 mm to about 7 mm, the convexity slope of about 55° to about 65°, the flexibility of about 15 N*mm to about 35 N*mm, the compressibility of about 10 N*mm to about 15 N*mm, and a ratio of dome thickness to hoop thickness of about 0.4: 1.0 to about 0.8: 1.0, wherein the dome thickness is a minimum cross sectional thickness of the convex insert in the convex dome, and the hoop thickness is a maximum cross sectional thickness of the convex insert in a concave body side portion.

19. The ostomy barrier appliance of any one of claims 1-18, wherein the convex insert is formed from an ethylene vinyl acetate copolymer having a modulus of about 7400 psi and durometer of about 90A.

20. The ostomy barrier appliance of any one of claims 1-19, wherein the skin barrier comprises a hydrocolloid adhesive.

21. The ostomy barrier appliance of any one of claims 1-20, wherein the skin barrier comprises a silicone adhesive.

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