EP4701588A1

EP4701588A1 - Deep convex ostomy barrier appliance

Info

Publication number: EP4701588A1
Application number: EP24724734.9A
Authority: EP
Inventors: Gregory J. CZAPLEWSKI
Original assignee: Hollister Inc
Current assignee: Hollister Inc
Priority date: 2023-04-25
Filing date: 2024-04-10
Publication date: 2026-03-04
Also published as: WO2024226298A1; AU2024261540A1

Abstract

A convex ostomy barrier appliance for attaching an ostomy pouch appliance to a peristomal skin surrounding a stoma includes a skin barrier and a convex insert attached to a distal side of the skin barrier to define the convexity of the convex ostomy barrier appliance. The deep convex insert is configured to have a depth, convexity slope, flexibility, compressibility, and a ratio of dome thickness to hoop thickness to provide a desired balance of depth, softness and flexibility while maintaining the integrity of the convex insert when applying pressure against the peristomal skin. A convex insert is also disclosed.

Description

DEEP CONVEX OSTOMY BARRIER APPLIANCE

BACKGROUND

[0001] The following description relates to ostomy appliances, more particularly, deep 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 attaches to the peristomal skin surface and protects the peristomal skin surface from exposure to stomal effluent. However, the topography of stomas and peristomal surfaces surrounding stomas varies among patients, and sealing an ostomy barrier appliance against such different peristomal surfaces and stomas remains 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 applies pressure to the user’s body in the area surrounding the stoma in such a way that the stoma projects outward and is received through a stoma opening defined in the convex base plate. However, some conventional convex base plates can be relatively stiff and inflexible, and may not conform to the user’s body well; thus, users often find them uncomfortable.

[0004] Soft convex base plates have been developed to improve user comfort. Some soft convex base plates may have a higher degree of flexibility than “firm” convex base plates. However, increased flexibility and comfort of the soft convex base plate can take away from the purpose of the convex base plate to maintain pressure against the peristomal area to adequately protrude the stoma.

[0005] Accordingly, it is desirable to provide a deep convex ostomy appliance that can provide softness and flexibility characteristics to improve user comfort while still having structural integrity to maintain adequate pressure against the peristomal area.

BRIEF SUMMARY

[0006] A deep convex insert for an ostomy barrier appliance configured to provide a desired balance of depth, softness and flexibility while maintaining the integrity of the deep convex insert when applying pressure against the peristomal skin is provided according to various embodiments.

[0007] In one aspect, a convex ostomy barrier appliance for attaching an ostomy pouch appliance to peristomal skin surrounding a stoma may include a skin barrier comprising an adhesive, a deep convex insert attached to a distal side of the skin barrier to define a convexity of the convex ostomy barrier appliance, and an inlet opening for receiving the stoma. The deep convex insert may include a base and a convex dome, and may be configured to have a depth of about 6 mm to about 15 mm, a convexity slope of about 25° to about 85°, a flexibility of about 50 N*mm to about 125 N*mm, and a compressibility of about 10 N*mm to about 40 N*mm. The depth is measured from a body side surface of the base to an apex of the deep convex insert. The convexity slope is the slope of a tangent line to the body side surface measured at one-half of the depth of the deep convex insert. The flexibility is measured in energy expended to deform the deep convex insert by 30% according to the flexibility test method described herein, and the compressibility is measured in energy expended to compress 3 mm of the convex dome according to the compressibility test method described herein. In embodiments, the convexity slope of the convex insert can vary based on clinical application. The convexity slope can be in the range of 15° to about 80°. For example, the convexity slope can be more gradual at about 45° +/- 10° or the convexity slope can be more aggressive at about 66° +/- 10°.

[0008] In an embodiment, the deep convex insert can include a plurality of radially extending members configured to define and support the convexity. Each of the plurality of radially extending members can be separated from an adjacent radially extending member by a gap, wherein each of the radially extending members can be configured to be flexed independently according to a force applied to the radially extending member as the skin barrier is pressed against the user’s peristomal skin. The deep convex insert can also include a middle portion connecting the convex dome and the base, wherein the convex dome can be formed by the plurality of radially extending members.

[0009] In an embodiment, the deep convex insert can include an inner rim, the base, and a middle portion extending therebetween. The middle portion can include the convex dome, a concave portion, and a plurality of openings and/or grooves. The plurality of openings and/or grooves can include a plurality of long openings and/or grooves radially extending in the convex dome and a plurality of short openings and/or grooves in the concave portion. [0010] The plurality of openings and/or grooves can include an equal number of the long openings and/or grooves and the short openings and/or grooves, wherein each of the plurality of short openings and/or grooves is aligned with one of the long openings and/or grooves to form a plurality of pairs of long opening/groove and short opening/groove. Each of the pairs of long opening/groove and short opening/groove can extend radially and spaced part from an adjacent pair of long opening/groove and short opening/groove and configured to facilitate bending and flexing of the convex ostomy barrier appliance along the pair of long opening/groove and short opening/groove. Each of the plurality of long openings and/or grooves can be defined by an opening extending entirely through the thickness of the deep convex insert and/or a groove having a depth that is less than the thickness of the deep convex insert.

[0011] In an embodiment, the deep convex insert can be configured to have a depth of about 8 mm to about 13 mm, a convexity slope of about 30° to about 80°, a flexibility of about 60 N*mm to about 100 N*mm, and a compressibility of about 15 N*mm to about 25 N*mm.

[0012] In another embodiment, the deep convex insert can be configured to have a depth of about 9 mm to about 11 mm, a convexity slope of about 65° to about 75°, a flexibility of about 70 N*mm to about 80 N*mm, and a compressibility of about 17 N*mm to about 23 N*mm.

[0013] In some embodiments, the deep convex insert can be configured to have a ratio of dome thickness to hoop thickness of about 0.2: 1.0 to about 0.6: 1.0, wherein the dome thickness is a minimum cross sectional thickness of the deep convex insert in the convex dome, and the hoop thickness is a maximum cross sectional thickness of the deep convex insert in a concave body side portion. In an embodiment, the deep convex insert can be configured to have a ratio of dome thickness to hoop thickness of about 0.3: 1.0 to about 0.5: 1.0. In another embodiment, the deep convex insert can be configured to have a ratio of dome thickness to hoop thickness of about 0.4:1.0 to about 0.5: 1.0.

[0014] In an embodiment, the thickness of the concave body side portion of the deep convex insert may decrease gradually from the hoop thickness toward the convex dome. The convex insert can be formed from an ethylene vinyl acetate (EVA) copolymer have a modulus of about 7400 psi and a durometer of about 90A.

[0015] In an embodiment, the deep convex insert can be configured to have a depth of about 9.5 mm, a convexity slope 0 of about 72°, a flexibility of about 75 N*mm, a compressibility of about 20 N*mm, and the ratio of dome thickness to hoop thickness of about 0.45: 1.0. some embodiments, the convexity slope can be more gradual at about 45° +/- 10° or the convexity slope can be more aggressive at about 66° +/- 10°. In some embodiments, the convexity slope is 45° +/- 10°. In some embodiments, the convexity slope is 66° +/-1O⁰.

[0016] In an aspect, a convex insert comprises a base and a convex dome defining a body side surface. The convex insert can have a depth of about 6 mm to about 15 mm, a convexity slope of about 25° to about 80°, a flexibility of about 50 N*mm to about 125 N*mm, and a compressibility of about 10 N*mm to about 40 N*mm. The depth is measured from a body side surface of the base to an apex of the convex insert, the convexity slope is a slope of a tangent line to the body side surface measured at one-half of the depth of the convex insert, 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.

[0017] In embodiments, the convex insert is configured to have a depth of about 8 mm to about 13 mm, a convexity slope of about 30° to about 80°, a flexibility of about 60 N*mm to about 100 N*mm, and a compressibility of about 15 N*mm to about 24 N*mm.

[0018] In embodiments, the convex insert can be configured to have a depth of about 9 mm to about 11 mm, a convexity slope of about 65° to about 75°, a flexibility of about 70 N*mm to about 80 N*mm, and a compressibility of about 17 N*mm to about 23 N*mm. In embodiments, the convex insert can be configured to have a ratio of dome thickness to hoop thickness of about 0.2: 1.0 to about 0.6: 1.0, in which 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.

[0019] In embodiments, the convex insert is configured to have a ratio of dome thickness to hoop thickness of about 0.3: 1.0 to about 0.5: 1.0, in which 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. In embodiments, the convex insert is configured to have a ratio of dome thickness to hoop thickness of about 0.4: 1.0 to about 0.5: 1.0, in which 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.

[0020] In embodiments, a thickness of the concave body side portion gradually decreases from the hoop thickness toward the convex dome. The convex insert can be formed from an ethylene vinyl acetate copolymer having a modulus of about 7400 psi and durometer of about 90A. One suitable material is an ethylene vinyl acetate copolymer having a modulus of about 7400 psi and durometer of about 90A. In embodiments, the convex insert is configured to have the depth of about 9.5 mm, the convexity slope of about 72°, the flexibility of about 75 N*mm, the compressibility of about 20 N*mm, and a ratio of dome thickness to hoop thickness of about 0.45:1.0. In some embodiments, the convexity slope is 45° +/- 10°, and in some embodiments, the convexity slope is 66° +/- 10°.

[0021] In any of the foregoing embodiments, the deep convex insert is formed from an ethylene vinyl acetate copolymer having a modulus of about 7400 psi and durometer of about 90A.

[0022] 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

[0023] 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:

[0024] FIG. l is a perspective body side view of a convex ostomy barrier appliance according to an embodiment;

[0025] FIG. 2 is a perspective distal side view of the convex ostomy barrier appliance of FIG. 1;

[0026] FIG. 3 is an illustration of a depth measurement of a convex skin barrier appliance;

[0027] FIG. 4 is an illustration of the compressibility characteristic of a convex skin barrier appliance; [0028] FIG. 5 is an illustration of the flexibility characteristic of a convex skin barrier appliance;

[0029] FIGS. 6A and 6B are illustrations of tension locations of a convex skin barrier appliance;

[0030] FIG. 7 is an illustration of a slope of a convex skin barrier appliance;

[0031] FIG. 8 is a perspective body side view of a deep convex insert according to an embodiment;

[0032] FIG. 9 is a perspective distal side view of the deep convex insert of FIG. 8;

[0033] FIG. 10 is a schematic partial cross sectional view of the deep convex insert of FIG. 8, and showing the location at which the convexity slope is measured;

[0034] FIG. 11 shows an example of a tensile testing device for measuring the compressibility of a convex ostomy barrier appliance;

[0035] FIG. 12 is a perspective view of a base platen and an adapter for the tensile testing device of FIG. 11 according to an embodiment;

[0036] FIG. 13 shows examples of differently sized securement plates for the tensile testing device of FIG. 11;

[0037] FIG. 14 shows an example of a load cell for the tensile testing device of FIG. 11;

[0038] FIG. 15 shows examples of differently sized platen inserts for the tensile testing device of FIG. 11;

[0039] FIG. 16 shows examples of securement pins for the tensile testing device of FIG. 11;

[0040] FIG. 17 shows an ostomy barrier appliance arranged on the tensile testing device of

FIG. 11 during setup for a compressibility test according to an embodiment;

[0041] FIG. 18 is a side view of an ostomy barrier appliance arranged on the tensile testing device of FIG. 11 during a compressibility test according to an embodiment;

[0042] FIG. 19 shows an example of a testing device configured to measure flexibility of an ostomy barrier appliance;

[0043] FIG. 20 shows an ostomy barrier appliance arranged in the testing device of FIG. 19 according to an embodiment;

[0044] FIG. 21 shows an example of an ostomy barrier appliance being prepared for a flexibility test according to an embodiment;

[0045] FIG. 22 shows another example of an ostomy barrier appliance being prepared for a flexibility test according to an embodiment;

[0046] FIG. 23 is a plan view showing an example of a trimmed ostomy barrier appliance for a flexibility test according to an embodiment;

[0047] FIG. 24 is an enlarged view of a positioning groove in the tensile testing device of FIG. 19 according to an embodiment;

[0048] FIG. 25 shows an example of an ostomy barrier appliance being positioned in the tensile testing device of FIG. 19 for a flexibility test according to an embodiment;

[0049] FIG. 26 shows another example of an ostomy barrier appliance being positioned in the tensile testing device of FIG. 19 for a flexibility test according to an embodiment;

[0050] FIG. 27 shows another example of an ostomy barrier appliance being positioned in the tensile testing device of FIG. 19 for a flexibility test according to an embodiment;

[0051] FIG. 28 is a partial perspective view of the tensile testing device of FIG. 19 with an ostomy barrier appliance arranged for a flexibility test according to an embodiment;

[0052] FIG. 29 shows an ostomy barrier appliance in an intended bending pattern during a flexibility test according to an embodiment;

[0053] FIG. 30 shows an ostomy barrier appliance in an unintended bending pattern during a flexibility test according to an embodiment;

[0054] FIG. 31 is a perspective body side view of a deep convex insert according to an embodiment; and

[0055] FIG. 32 is a perspective distal side view of the deep convex insert of FIG. 31.

DETAILED DESCRIPTION

[0056] While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiment illustrated.

[0057] FIGS. 1 and 2 show a convex ostomy barrier appliance 10 according to an embodiment. FIG. 1 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 can be a base plate configured for detachable connection to an ostomy pouch (not shown). The ostomy barrier appliance 10 can include a skin barrier adhesive 12 and a convex insert 14 attached to a distal side of the skin barrier adhesive 12 for supporting a convex portion 15 and defining a convex body side contour 17 of the ostomy barrier appliance 10. The ostomy barrier appliance 10 can also include an outer flange 16 configured to attach to the user’s body peristomal skin around the stoma, for example, with an adhesive, and a stoma opening 18 (also referred to herein as an inlet opening) for receiving the stoma. The ostomy barrier appliance 10 can include a coupling member 20 on the pouch-facing side (also referred to herein as a distal side), to which an ostomy pouch appliance can be coupled. The stoma opening 18 extends 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) mounted to the ostomy barrier appliance 10.

[0058] Characteristics that define the convexity of an ostomy barrier appliance, such as a convex skin barrier, can include depth, compressibility, flexibility, tension location, 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). Referring to FIG. 3, the depth of a convex skin barrier can be defined as the distance from the apex of the dome to the base of the convex skin barrier. The depth can be measured as the magnitude of the convexity from the base lying on the peristomal skin to the highest point of the 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 the depth of a convex skin barrier to provide an optimal seal around the peristomal skin.

[0059] 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. The compressibility may be measured as the force required to displace or flatten the dome portion of the convex skin barrier by a predetermined distance. A relatively easily compressible deep convex barrier may conform better to users with postoperative edema and/or a relatively firm abdomen. 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. [0060] The flexibility of a convex skin barrier can be defined as how easily the convex skin barrier can bend, as illustrated in FIG. 5. The flexibility is an important characteristic to consider when a skin barrier needs to bend to conform to abdominal contours. A relatively more flexible convex skin barrier may work well for users with multiple creases around stoma due to loose skin.

[0061] 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. 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. 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.

[0062] 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. 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.

[0063] The convex insert 14 may be a deep convex insert 14 having a relatively deep depth of convexity according to various embodiments. The deep convex insert 14 may be configured to provide a desirable balance of depth, softness, and flexibility of the ostomy barrier appliance 10 for increased user comfort and fit while maintaining the integrity of the deep convex insert 14 when applying pressure against the peristomal skin surface to facilitate a flush or recessed stoma to protrude adequately to be received through the stoma opening 18. Deep convex insert configurations have been identified that can provide the desired convexity balance when used in an ostomy barrier appliance.

[0064] FIGS. 8-10 show the deep convex insert 14 according to an embodiment. FIG. 8 is a perspective body side view of the deep convex insert 14, FIG. 9 is a perspective distal side view of the deep convex insert 14, and FIG. 10 is a schematic partial cross sectional view of the deep convex insert 14. The deep convex insert 14 may be used in an ostomy barrier appliance, such as the convex ostomy barrier appliance 10 that generally includes a skin barrier adhesive 12, an outer flange 16 and an inlet opening 18 for receiving a stoma. The deep 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 proximate the inlet opening 18. 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.

[0065] 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. 8 and 9. 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 deep convex insert 14 may be configured to include 10 radially extending members 28.

[0066] The convexity characteristics to achieve the desired balance of depth, softness and flexibility while maintaining the integrity of the deep convex insert 14 to apply sufficient pressure against the peristomal skin may be defined by a combination of a range of depth, a range of convexity, a range of flexibility, and a range of compressibility. Further, it has been discovered that a ratio of a dome thickness 46 to a hoop thickness 48 (FIG. 10) may be an important component to consider when configuring the deep convex insert 14 having the target combination of depth, slope, softness, and flexibility that can still maintain the intergrity when applying pressure against the perisomtal skin without collapsing.

[0067] The depth D of the deep convex insert 14 is measured from a body side surface of the base 22 to the apex of the deep convex insert 14 as shown in FIG. 10.

[0068] The convexity slope 0 is the slope of a tangent line T to the body side surface 44 measured at one half (1/2) of the depth (D) of the convex insert 14.

[0069] The compressibility of an ostomy barrier appliance, for example, the convex ostomy barrier appliance 10 or the deep convex insert 14, 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 pouch-facing 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.

[0070] 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.

[0071] 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 base platen 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.

[0072] 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 semi-circular openings 134 may correspond to the size (diameter) of a convex portion 15 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 22 of the convex insert 14, without constraining the convex portion.

[0073] 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 1 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.

[0074] 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 sized ostomy barrier appliances.

[0075] 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.

[0076] 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 15. 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 15. Accordingly, the convex portion 15 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.

[0077] 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 outer flange 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 15 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 15 during the compressibility test.

[0078] 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 KIMWIPE, 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 15 without touching the convex portion 15, 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 15 to apply a preload of about 0.4 N. [0079] The load cell 118 may be controlled to move at a rate of 5 inches per minute to compress the convex portion 15. 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.

[0080] The compressibility test may be performed on ostomy barrier appliances of different sizes. For example, the compressibility test may be performed on ostomy barrier appliances having 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.

[0081] 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.

[0082] FIGS. 19-30 are illustrations of a test apparatus and a 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.

[0083] 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 that injection-molded portions, for example, the coupling flange 22, are disposed in contact with the platen inserts 216, 218.

[0084] 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 deep convex insert 26, 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.

[0085] 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.

[0086] 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.

[0087] 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. [0088] 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.

[0089] 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).

[0090] 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 of the ostomy barrier appliance 10.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] 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.

[0095] Samples of the deep convex 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 deep convex insert sample was recorded. The “energy at -30% strain” as used herein is energy expended to deform a deep convex insert 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):

[0096] For the flexibility test, each deep 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 deep 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 deep convex insert sample.

[0097] In an embodiment, the the deep convex insert 14 may be configured to have a depth D of about 6 mm to about 15 mm, preferably about 8 mm to about 13 mm, more preferably about 9 mm to about 11 mm, a convexity slope 0 of about 25° to about 85°, preferably about 30° to about 80°, more preferably about 65° to about 75°, flexibility measured in energy expended to deform the deep convex insert by 30% according to the flexibility test method of about 50 N*mm to about 125 N*mm, preferably about 60 N*mm to about 100 N*mm, more preferably about 70 N*mm to about 80 N*mm, and compressibility measured in energy expended to compress 3 mm of the convex portion 15 of the deep convex inert according to the compressibility test method of about 10 N*mm to about 40 N*mm, preferably about 15 N*mm to about 25 N*mm, more preferably about 17 N*mm to about 23 N*mm. In such an embodiment, the deep convex insert 14 may be configured to have a ratio of dome thickness 46 to hoop thickness 48 of about 0.2: 1.0 to about 0.6: 1.0, preferably about 0.3: 1.0 to about 0.5: 1.0, and more preferably of about 0.4: 1.0 to about 0.5: 1.0. The dome thickness is a minimum cross sectional thickness of the deep convex insert 14 in the convex body side portion 44, and the hoop thickness is a maximum cross sectional thickness of the deep convex insert 14 in the concave body side portion 42. In embodiments, the convexity slope 0 of the convex insert 14 can vary based on clinical application. The convexity slope 0 can be in the range of about 15° to about 80°. For example, the convexity slope 0 can be more gradual at about 45° +/- 10° or the convexity slope 0 can be more aggressive at about 66° +/- 10°.

[0098] In an embodiment, the deep convex insert 14 may be configured to have a depth D of about 9.5 mm, a convexity slope 0 of about 72°, flexibility measured in energy expended to deform the deep convex insert by 30% according to the flexibility test method of about 75 N*mm, compressibility measured in energy expended to compress 3 mm of the convex portion 15 of the deep convex inert according to the compressibility test method of about 20 N*mm, and a ratio of dome thickness 46 to hoop thickness 48 of about 0.45: 1.0. For example, the deep convex insert 14 may be configured to have a dome thickness 46 of about 1.75 mm and a hoop thickness of about 3.8 mm. In the embodiment of FIG. 10, the thickness of the concave portion 42 of the deep convex insert 14 may decrease from the hoop thickness toward the dome thickness.

[0099] FIGS. 31 and 32 show a deep convex insert 414 according to an embodiment. FIG. 31 is a body side view of the deep convex insert 414, and FIG. 32 is a distal side view of the deep convex insert 414. The deep 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 deep convex insert 14 and may include an inner rim 418, outer rim 420 (also referred to herein as a base), and a middle portion comprising a plurality of openings and/or grooves 416. The plurality of openings and/or grooves 416 may include a plurality of long openings and/or grooves 470 radially extending in a convex dome portion 466 and a plurality of short openings and/or grooves 472 in a concave middle portion 464 of the deep convex insert 414.

[00100] In an embodiment, the plurality of openings and/or grooves 416 may include the same number of the long openings and/or grooves 470 and the short openings and/or grooves 472, wherein each of the plurality of short openings and/or grooves 472 may be aligned with a corresponding long opening/groove 470 as shown in FIG. 31. In such an embodiment, each pair of the long opening/groove 470 and short opening/groove 472, which extend radially and spaced part from adjacent pairs, may be configured to facilitate bending and flexing of an ostomy barrier appliance including the deep convex insert 414 along the pairs of long opening/groove 470 and short opening/groove 472. In the embodiment of FIGS. 31 and 32, each of the plurality of long openings/grooves 470 may be an opening formed entirely through the thickness of the deep convex insert 414, and each of the plurality of short openings/grooves 472 may be formed as a groove having a depth that is less than the thickness of the deep convex insert 414, such that the groove 472 does not extend through the entire thickness of the deep convex insert 414. In some embodiments, the plurality of long openings and/or grooves 470 and the plurality of short openings and/or grooves 472 may include only openings, only grooves, or a mixture of openings and grooves.

[00101] The deep convex insert 14, 414 may be formed from a suitable material, such as polymeric materials, rubber, silicone, or metallic materials. For example, the deep convex insert 14, 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, deep convex insert 14, 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.

[00102] 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.

[00103] 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.

[00104] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present disclosure. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

CLAIMS What is claimed is:

1. A convex ostomy barrier appliance for attaching an ostomy pouch appliance to a peristomal skin surrounding a stoma, comprising: a skin barrier comprising an adhesive; a convex insert attached to a distal side of the skin barrier to define a convexity of the convex ostomy barrier appliance, and an inlet opening for receiving the stoma; and wherein the convex insert includes a base and a convex dome, wherein the convex insert is configured to have a depth of about 6 mm to about 15 mm, a convexity slope of about 25° to about 85°, a flexibility of about 50 N*mm to about 125 N*mm, and a compressibility of about 10 N*mm to about 40 N*mm, wherein the depth is measured from a body side surface of the base to an apex of the deep convex insert, wherein the convexity slope is a slope of a tangent line to the body side surface measured at one-half of the depth of the convex insert, wherein the flexibility is measured in energy expended to deform the deep 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.

2. The convex ostomy barrier appliance of claim 1, wherein the convex insert comprises a plurality of radially extending members configured to define and support the convexity, 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 a force applied to each of the radially extending member as the skin barrier is pressed against the user’s peristomal skin.

3. The convex ostomy barrier appliance of claim 2, wherein the convex insert further comprises a middle portion connecting the convex dome and the base, wherein the convex dome is formed by the plurality of radially extending members.

4. The convex ostomy barrier appliance of claim 1, wherein the convex insert comprises an inner rim, the base, and a middle portion extending between the inner rim and the base, wherein the middle portion includes the convex dome, a concave portion and a plurality of openings and/or grooves, wherein the plurality of openings and/or grooves includes a plurality of long openings and/or grooves radially extending in the convex dome and a plurality of short openings and/or grooves in the concave portion.

5. The convex ostomy barrier appliance of claim 4, wherein the plurality of openings and/or grooves includes an equal number of the long openings and/or grooves and the short openings and/or grooves, wherein each of the plurality of short openings and/or grooves is aligned with one of the long openings and/or grooves to form a plurality of pairs of long opening/groove and short opening/groove, wherein each of the pairs of long opening/groove and short opening/groove extends radially and spaced part from an adjacent pair of long opening/groove and short opening/groove and configured to facilitate bending and flexing of the convex ostomy barrier appliance along the pair of long opening/groove and short opening/groove.

6. The convex ostomy barrier assembly of any of claims 4-5, wherein each of the plurality of long openings and/or grooves is an opening extending entirely through a thickness of the deep convex insert, and each of the plurality of short openings and/or grooves is a groove having a depth that is less than a thickness of the deep convex insert, such that the groove does not extend through the entire thickness of the deep convex insert.

7. The convex ostomy barrier appliance of any of claims 1-6, wherein the convex insert is configured to have the depth of about 8 mm to about 13 mm, the convexity slope of about 30° to about 80°, the flexibility of about 60 N*mm to about 100 N*mm, and the compressibility of about 15 N*mm to about 25 N*mm.

8. The convex ostomy barrier appliance of any of claims 1-6, wherein the convex insert is configured to have the depth of about 9 mm to about 11 mm, the convexity slope of about 65° to about 75°, the flexibility of about 70 N*mm to about 80 N*mm, and the compressibility of about 17 N*mm to about 23 N*mm.

9. The convex ostomy barrier appliance of any of claims 1-8, wherein the convex insert is configured to have a ratio of dome thickness to hoop thickness of about 0.2: 1.0 to about 0.6:1.0, wherein the dome thickness is a minimum cross sectional thickness of the deep 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.

10. The convex ostomy barrier appliance of any of claims 1-8, wherein the convex insert is configured to have a ratio of dome thickness to hoop thickness of about 0.3: 1.0 to about 0.5:1.0, 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.

11. The convex ostomy barrier appliance of any of claims 1-8, wherein the convex insert is configured to have a ratio of dome thickness to hoop thickness of about 0.4: 1.0 to about 0.5:1.0, 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.

12. The convex ostomy barrier appliance of any of claims 9-11, wherein a thickness of the concave body side portion gradually decreases from the hoop thickness toward the convex dome.

13. The convex ostomy barrier appliance of any of claims 1-12, wherein the convex insert is formed from an ethylene vinyl acetate copolymer having a modulus of about 7400 psi and durometer of about 90A.

14. The convex ostomy barrier appliance of any of claims 1-13, wherein the convex insert is configured to have the depth of about 9.5 mm, the convexity slope 0 of about 72°, the flexibility of about 75 N*mm, the compressibility of about 20 N*mm, and a ratio of dome thickness to hoop thickness of about 0.45:1.0.

15. The convex ostomy barrier appliance of any of claims 1-7, wherein the convexity slope is 45° +/-10° .

16. The convex ostomy barrier appliance of any of claims 1-13, wherein the convexity slope is 66° +/- 10°.

17. A convex insert comprising a base and a convex dome defining a body side surface, wherein the convex insert having a depth of about 6 mm to about 15 mm, a convexity slope of about 25° to about 80°, a flexibility of about 50 N*mm to about 125 N*mm, and a compressibility of about 10 N*mm to about 40 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 slope of a tangent line to the body side surface measured at one-half of the depth 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 convex insert of claim 17, wherein the convex insert is configured to have the depth of about 8 mm to about 13 mm, the convexity slope of about 30° to about 80°, the flexibility of about 60 N*mm to about 100 N*mm, and the compressibility of about 15 N*mm to about 24 N*mm.

19. The convex insert of claim 17-18, wherein the convex insert is configured to have the depth of about 9 mm to about 11 mm, the convexity slope of about 65° to about 75°, the flexibility of about 70 N*mm to about 80 N*mm, and the compressibility of about 17 N*mm to about 23 N*mm.

20. The convex insert of any of claims 17-19, wherein the convex insert is configured to have a ratio of dome thickness to hoop thickness of about 0.2: 1.0 to about 0.6: 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.

21. The convex insert of any of claims 17-20, wherein the convex insert is configured to have a ratio of dome thickness to hoop thickness of about 0.3: 1 .0 to about 0.5:1 .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.

22. The convex insert of any of claims 17-21, wherein the convex insert is configured to have a ratio of dome thickness to hoop thickness of about 0.4: 1.0 to about 0.5:1.0, 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.

23. The convex insert of any of claims 17-22, wherein a thickness of the concave body side portion gradually decreases from the hoop thickness toward the convex dome.

24. The convex insert of any of claims 17-23, wherein the convex insert is formed from an ethylene vinyl acetate copolymer having a modulus of about 7400 psi and durometer of about 90A.

25. The convex insert of any of claims 17-24, wherein the convex insert is formed from an ethylene vinyl acetate copolymer having a modulus of about 7400 psi and durometer of about 90A.

26. The convex insert of any of claims 17-25, wherein the convex insert is configured to have the depth of about 9.5 mm, the convexity slope of about 72°, the flexibility of about 75 N*mm, the compressibility of about 20 N*mm, and a ratio of dome thickness to hoop thickness of about 0.45:1.0.

27. The convex insert of any of claims 17-18, wherein the convexity slope is 45° +/- 10°.

28. The convex insert of any of claims 17-25, wherein the convexity slope is 66° +/-

10°.