Deep convex ostomy barrier appliance

Abstract

A convex ostomy barrier appliance for attaching an ostomy pouch appliance to the periostomy skin surrounding a stoma includes a skin barrier portion and a convex insertion portion attached distal to the skin barrier portion, defining the convex shape of the convex ostomy barrier appliance. The deep convex insertion portion is configured to have a depth, convex slope, flexibility, compressibility, and a ratio of dome thickness to hoop thickness that provides a desired balance of depth, flexibility, and pliability while maintaining the integrity of the convex insertion portion when pressure is applied to the periostomy skin. A convex insertion portion is also disclosed.

Description

Technical Field

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

Background Art

[0002] An ostomy pouch for collecting excrement is used by individuals who have undergone surgeries such as colostomy, ileostomy, or urinary diversion. The ostomy pouch may be fixed to the user via an ostomy barrier appliance that seals around the stoma, adheres to the surface of the skin around the stoma, and protects the surface of the skin around the stoma from exposure to stoma effluent. However, the topography of the stoma and the peristomal surface surrounding the stoma varies among patients, and there remains room for further improvement in adhering the ostomy barrier appliance to such different peristomal surfaces and stomas. For example, the stoma may be more or less protruding, flat, or sunken.

[0003] When the stoma is recessed or sunken into the user's body, a convex ostomy barrier appliance such as a convex baseplate including a convex insertion portion may be used. The convex baseplate applies pressure to the user's body in the area surrounding the stoma such that the stoma protrudes outward and is received through a stoma opening defined in the convex baseplate. However, some conventional convex baseplates are relatively rigid and non-flexible and may not conform well to the user's body. Thus, users often feel discomfort from them.

[0004] To improve user comfort, soft convex baseplates have been developed. Some soft convex baseplates may have a higher level of flexibility than "rigid" convex baseplates. However, the improved flexibility and comfort provided by soft convex baseplates may deviate from the purpose of a convex baseplate, which is to maintain pressure on the area around the stoma in order to adequately protrude the stoma.

[0005] Therefore, it is desirable to provide a deep convex ostomy appliance that can offer flexibility and pliability to improve user comfort while still possessing structural integrity to maintain sufficient pressure on the area around the stoma. [Overview of the project]

[0006] A deep convex insertion for an ostomy barrier appliance is provided according to various embodiments, configured to provide a desired balance of depth, flexibility, and pliability while maintaining the integrity of the deep convex insertion when pressure is applied to the skin around the ostomy.

[0007] In one embodiment, a convex ostomy barrier appliance for attaching an ostomy pouch appliance to the periostomy skin surrounding a stoma may include a skin barrier portion containing adhesive, a deep convex insertion portion attached distal to the skin barrier portion and defining the convex shape of the convex ostomy barrier appliance, and an inlet opening for receiving the stoma. The deep convex insertion portion may include a base and a convex dome, and may be configured to have a depth of approximately 6 mm to approximately 15 mm, a convex slope of approximately 25° to approximately 85°, a flexibility of approximately 50 N·mm to approximately 125 N·mm, and a compressibility of approximately 10 N·mm to approximately 40 N·mm. The depth is measured from the body-side surface of the base to the apex of the deep convex insertion portion. The convex slope is the tangent slope to the body-side surface, measured at a position half the depth of the deep convex insertion portion. Flexibility is measured by the energy expended to deform the deep convex insert by 30% according to the flexibility test method described herein, and compressibility is measured by the energy expended to compress the convex dome by 3 mm according to the compressibility test method described herein. In embodiments, the convex slope of the convex insert may vary based on the clinical application. The convex slope may be in the range of 15° to about 80°. For example, the convex slope can be gentler, about 45°±10°, or it can be steeper, about 66°±10°.

[0008] In one embodiment, the deep convex insertion portion may include a plurality of radially extending members configured to define and support the convex shape. Each of the plurality of radially extending members may be separated from adjacent radially extending members by gaps, and each radially extending member may be configured to bend independently in accordance with the force applied to the radially extending member when the skin barrier portion is pressed against the user's ostomy-peripheral skin. The deep convex insertion portion may also include an intermediate portion connecting the convex dome and the base, and the convex dome may be formed by the plurality of radially extending members.

[0009] In one embodiment, the deep convex insertion portion may include an inner rim, a base, and an intermediate portion extending between the inner rim and the base. The intermediate portion may include a convex dome, a recess, and a plurality of openings and / or grooves. The plurality of openings and / or grooves may include a plurality of long openings and / or grooves extending radially within the convex dome and a plurality of short openings and / or grooves within the recess.

[0010] Multiple openings and / or grooves may include an equal number of long openings and / or grooves and short openings and / or grooves, each of which is aligned with one of the long openings and / or grooves to form multiple pairs of long openings / grooves and short openings / grooves. Each pair of long openings / grooves and short openings / grooves may extend radially, be spaced apart from adjacent pairs of long openings / grooves and short openings / grooves, and be configured to facilitate curvature and bending of the convex ostomy barrier appliance along the pairs of long openings / grooves and short openings / grooves. Each of the multiple long openings and / or grooves may be defined by an opening that extends through the thickness of the deep convex insertion and / or a groove that is shallower than the thickness of the deep convex insertion.

[0011] In one embodiment, the deep convex insertion portion may be configured to have a depth of approximately 8 mm to approximately 13 mm, a convex slope of approximately 30° to approximately 80°, a flexibility of approximately 60 N·mm to approximately 100 N·mm, and a compressibility of approximately 15 N·mm to approximately 25 N·mm.

[0012] In another embodiment, the deep convex insertion portion may be configured to have a depth of approximately 9 mm to approximately 11 mm, a convex slope of approximately 65° to approximately 75°, a flexibility of approximately 70 N·mm to approximately 80 N·mm, and a compressibility of approximately 17 N·mm to approximately 23 N·mm.

[0013] In some embodiments, the deep convex insertion section may be configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.2:1.0 to approximately 0.6:1.0. The dome thickness is the minimum cross-sectional thickness of the deep convex insertion section in the convex dome, and the hoop thickness is the maximum cross-sectional thickness of the deep convex insertion section in the concave body portion. In one embodiment, the deep convex insertion section may be configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.3:1.0 to approximately 0.5:1.0. In another embodiment, the deep convex insertion section may be configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.4:1.0 to approximately 0.5:1.0.

[0014] In one embodiment, the thickness of the concave body-side portion of the deep convex insertion section may gradually decrease from the hoop thickness toward the convex dome. The convex insertion section can be formed from an ethylene vinyl acetate (EVA) copolymer having an elastic modulus of approximately 7400 psi and a durometer hardness of approximately 90 A.

[0015] In one embodiment, the deep convex insertion section may be configured such that it has a depth of approximately 9.5 mm, a convex slope Θ of approximately 72°, a flexibility of approximately 75 N·mm, a compressibility of approximately 20 N·mm, and a dome thickness to hoop thickness ratio of approximately 0.45:1.0. In some embodiments, the convex slope can be made gentler, approximately 45° ± 10°, or steeper, approximately 66° ± 10°. In some embodiments, the convex slope is 45° ± 10°. In some embodiments, the convex slope is 66° ± 10°.

[0016] In one embodiment, the convex insertion portion includes a base and a convex dome defining the body-side surface. The convex insertion portion may be configured to have a depth of approximately 6 mm to approximately 15 mm, a convex slope of approximately 25° to approximately 80°, a flexibility of approximately 50 N·mm to approximately 125 N·mm, and a compressibility of approximately 10 N·mm to approximately 40 N·mm. The depth is measured from the body-side surface of the base to the apex of the convex insertion portion, the convex slope is the tangent slope to the body-side surface measured at half the depth of the convex insertion portion, the flexibility is measured by the energy expended to deform the convex insertion portion by 30% according to a flexibility test method, and the compressibility is measured by the energy expended to compress the convex dome of the convex insertion portion by 3 mm according to a compressibility test method.

[0017] In this embodiment, the convex insertion portion may be configured to have a depth of approximately 8 mm to approximately 13 mm, a convex slope of approximately 30° to approximately 80°, a flexibility of approximately 60 N·mm to approximately 100 N·mm, and a compressibility of approximately 15 N·mm to approximately 24 N·mm.

[0018] In the embodiment, the convex insertion portion may be configured to have a depth of approximately 9 mm to approximately 11 mm, a convex slope of approximately 65° to approximately 75°, a flexibility of approximately 70 N·mm to approximately 80 N·mm, and a compressibility of approximately 17 N·mm to approximately 23 N·mm. In the embodiment, the convex insertion portion may be configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.2:1.0 to approximately 0.6:1.0. The dome thickness is the minimum cross-sectional thickness of the convex insertion portion in the convex dome, and the hoop thickness is the maximum cross-sectional thickness of the convex insertion portion in the concave body side portion.

[0019] In one embodiment, the convex insertion portion is configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.3:1.0 to approximately 0.5:1.0, where the dome thickness is the minimum cross-sectional thickness of the convex insertion portion in the convex dome, and the hoop thickness is the maximum cross-sectional thickness of the convex insertion portion in the concave body side portion. In another embodiment, the convex insertion portion is configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.4:1.0 to approximately 0.5:1.0, where the dome thickness is the minimum cross-sectional thickness of the convex insertion portion in the convex dome, and the hoop thickness is the maximum cross-sectional thickness of the convex insertion portion in the concave body side portion.

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

[0021] In any of the embodiments described above, the deep convex insertion portion is formed from an ethylene vinyl acetate copolymer having an elastic modulus of approximately 7400 psi and a durometer hardness of approximately 90 A.

[0022] The general descriptions above and the detailed descriptions below are illustrative and not limiting to this disclosure. Other aspects, purposes, and advantages will become more apparent from the detailed descriptions below in conjunction with the accompanying drawings.

[0023] The advantages and merits of this embodiment will become more readily apparent to those skilled in the art after reviewing the following detailed description and accompanying drawings. [Brief explanation of the drawing]

[0024] [Figure 1] Perspective view of the body side of the convex ostomy barrier device according to one embodiment. [Figure 2] Distal perspective view of the convex ostomy barrier device of FIG. 1. [Figure 3] Diagram showing the depth measurement of the convex skin barrier device. [Figure 4] Diagram showing the compression characteristics of the convex skin barrier device. [Figure 5] Diagram showing the flexible characteristics of the convex skin barrier device. [Figure 6A] Diagram showing the tension position of the convex skin barrier device. [Figure 6B] Another diagram showing the tension position of the convex skin barrier device. [Figure 7] Diagram showing the gradient of the convex skin barrier device. [Figure 8] Perspective view of the body side of the deep convex insertion part according to one embodiment. [Figure 9] Distal perspective view of the deep convex insertion part of FIG. 8. [Figure 10] Schematic partial cross-sectional view of the deep convex insertion part of FIG. 8, showing the position where the convex gradient is measured. [Figure 11] Diagram showing an example of a tensile test device for measuring the compressibility of the convex ostomy barrier device. [Figure 12] Perspective view of the base platen and adapter for the tensile test device of FIG. 11 according to one embodiment. [Figure 13] Diagram showing examples of fixed plates of different sizes for the tensile test device of FIG. 11. [Figure 14] Diagram showing an example of a load cell for the tensile test device of FIG. 11. [Figure 15] Diagram showing examples of platen insertion parts of different sizes for the tensile test device of FIG. 11. [Figure 16] Diagram showing an example of a fixing pin for the tensile test device of FIG. 11. [Figure 17]This figure shows an ostomy barrier appliance placed on the tensile testing apparatus of Figure 11 during setup for a compressibility test, according to one embodiment. [Figure 18] This is a side view of an ostomy barrier appliance placed on the tensile testing apparatus shown in Figure 11 during a compressibility test, according to one embodiment. [Figure 19] This figure shows an example of a test apparatus configured to measure the flexibility of an ostomy barrier appliance. [Figure 20] This figure shows an ostomy barrier appliance placed in the test apparatus shown in Figure 19, according to one embodiment. [Figure 21] This figure shows an example of an ostomy barrier appliance prepared for a flexibility test according to one embodiment. [Figure 22] This figure shows another example of an ostomy barrier appliance prepared for a flexibility test according to one embodiment. [Figure 23] This is a plan view showing an example of an ostomy barrier appliance trimmed for flexibility testing according to one embodiment. [Figure 24] This is an enlarged view of the positioning groove of the tensile testing apparatus shown in Figure 19, according to one embodiment. [Figure 25] This figure shows an example of an ostomy barrier appliance placed in the tensile testing apparatus shown in Figure 19 for a flexibility test, according to one embodiment. [Figure 26] This figure shows another example of an ostomy barrier appliance placed in the tensile testing apparatus of Figure 19 for a flexibility test, according to one embodiment. [Figure 27] This figure shows another example of an ostomy barrier appliance placed in the tensile testing apparatus of Figure 19 for a flexibility test, according to one embodiment. [Figure 28] Figure 19 is a partial perspective view of a tensile testing apparatus in which an ostomy barrier appliance is positioned for flexibility testing, according to one embodiment. [Figure 29] This figure shows the intended bending pattern of an ostomy barrier appliance during a flexibility test according to one embodiment. [Figure 30]This figure shows an ostomy barrier appliance exhibiting an unintended bending pattern during a flexibility test, according to one embodiment. [Figure 31] This is a perspective view of the body-side side of a deep convex insertion part according to one embodiment. [Figure 32] Figure 31 is a perspective view of the distal side of the deep convex insertion section. [Modes for carrying out the invention]

[0025] While various forms of embodiment are possible with respect to the present disclosure, it should be considered illustrative and is not intended to limit the present disclosure to any particular embodiment shown in the drawings. A currently preferred embodiment is shown in the drawings and described below.

[0026] Figures 1 and 2 show a convex ostomy barrier appliance 10 according to one embodiment. Figure 1 is a body-side perspective view of the convex ostomy barrier appliance 10, and Figure 2 is a distal perspective view of the convex ostomy barrier appliance 10. The ostomy barrier appliance 10 may be a base plate configured to be detachably connected to an ostomy pouch (not shown). The ostomy barrier appliance 10 may include a skin barrier adhesive 12 and a convex insertion portion 14 attached distal to the skin barrier adhesive 12 to support a convex portion 15 and define a convex body-side contour 17 of the ostomy barrier appliance 10. The ostomy barrier appliance 10 may also include an outer flange 16 configured to be attached to the periostomy skin around the stoma on the user's body, for example using an adhesive, and a stoma opening 18 (also referred to herein as an entrance opening) for receiving the stoma. The ostomy barrier appliance 10 may include a connecting member 20 on the pouch-facing side (also referred to herein as the distal side), to which an ostomy pouch appliance can be connected. The stoma opening 18 extends through the ostomy barrier appliance 10 from the body-facing side to the pouch-facing side. Thus, waste from the stoma can be received in an ostomy pouch (not shown) attached to the ostomy barrier appliance 10.

[0027] Characteristics defining the shape of the convex portion of an ostomy barrier appliance, such as a convex skin barrier portion, can include depth, compressibility, flexibility, tension position, and gradient. See "Characteristics of Convex Skin Barriers and Clinical Application: Results of an International Consensus Panel" by McNichol, L., Cobb, T., Depaifve, Y., Quigley, M., Smitka, K., & Gray, M., J Wound Ostomy Continence Nurs, (2021) 48(6). Referring to Figure 3, the depth of the convex skin barrier portion can be defined as the distance from the apex of the dome to the base of the convex skin barrier portion. The depth can be measured as the size of the convex portion from the base on the periostomy skin to the highest point of the convex skin barrier portion, as shown in Figure 3. When selecting the depth of the convex skin barrier to optimally seal the skin around the stoma, it is necessary to carefully consider the individual user's peristoma condition, including the depth of wrinkles and folds around the stoma.

[0028] The compressibility of the convex skin barrier can be defined as the ability of the dome portion to be displaced or flattened, as shown in Figure 4. Compressibility may also be measured as the force required to displace or flatten the dome portion of the convex skin barrier by a predetermined distance. A deep convex barrier that is relatively easily compressible may be better suited to users with postoperative edema and / or a relatively firm abdomen. A rigid convex barrier with relatively low compressibility may apply more pressure to the skin around the stoma, providing the necessary support to users with a relatively flexible abdominal tone and / or wrinkles around the stoma.

[0029] The flexibility of the convex skin barrier can be defined as how easily it can be bent, as shown in Figure 5. Flexibility is an important property to consider when the skin barrier needs to bend to conform to the contour of the abdomen. A relatively flexible convex skin barrier may function well for users with multiple wrinkles around the stoma due to loose skin.

[0030] The tension position of the convex skin barrier is defined as the position where the convex dome exerts downward and outward forces on the topography around the stoma, as shown in Figures 6A and 6B. A convex skin barrier configured to apply tension near the stoma can provide a consistent and reliable seal around a stoma that is flush with the skin or recessed beneath the skin. For users with wrinkles and folds around the stoma, a convex barrier skin barrier configured to apply tension away from the stoma can help flatten the skin around the stoma for a better seal.

[0031] The slope of the convex skin barrier is defined as the angle from the base of the dome to the circumference of the dome's apex, as shown in Figure 7. Wrinkles and folds around the stoma can impair the seal between the skin barrier and the skin. The seal can be improved by adjusting the slope of the convex skin barrier according to the user's ostomy topography. For example, a convex skin barrier with a relatively small slope and a wider flat area may help flatten wrinkles and folds in the skin around the stoma to achieve a good seal.

[0032] The convex insertion portion 14 may be a deep convex insertion portion 14, depending on the various embodiments, having a relatively deep convexity. The deep convex insertion portion 14 may be configured to provide a desired balance of depth, flexibility, and pliability of the ostomy barrier appliance 10 to enhance user comfort and fit, while maintaining the integrity of the deep convex insertion portion 14 when pressure is applied to the periostomy skin surface to easily and sufficiently protrude a flat or recessed stoma through the stoma opening 18. Configurations of deep convex insertion portions have been identified that can provide a desired convexity balance when used in an ostomy barrier appliance.

[0033] Figures 8 to 10 show a deep convex insertion section 14 according to one embodiment. Figure 8 is a perspective view of the deep convex insertion section 14 from the body side, Figure 9 is a perspective view of the deep convex insertion section 14 from the distal side, and Figure 10 is a schematic partial cross-sectional view of the deep convex insertion section 14. The deep convex insertion section 14 may be used in an ostomy barrier appliance such as a convex ostomy barrier appliance 10 which generally includes a skin barrier adhesive 12, an outer flange 16, and an entrance opening 18 for receiving a stoma. The deep convex insertion section 14 may include a base 22, a dome 24, and an intermediate section 26 connecting the base 22 and the dome 24. The dome 24 may be defined by a plurality of radially extending members 28, each of which may be separated by a gap 30. Each of the radially extending members 28 may include a circumferential end 32 adjacent to the entrance opening 18. The dome 24 and the intermediate portion 26 may extend from the base 22 and project toward the body so that the base 22 and the dome 24 are positioned in different planes.

[0034] In this embodiment, each of the gaps 30 may include a substantially elliptical or round end 34, and the width of the gap 30 may narrow from a first end adjacent to the circumferential end 32 toward the round end 34, as shown in Figures 8 and 9, and widen at the round end 34. The increase in the width of the gap 30 at the round end 34 may be configured to improve the compressibility and / or flexibility of each of the radially extending members 28. The base 22 may include an extended side wing portion 36 and an opening 38 defined within the side wing portion 36 for engaging with a stoma belt connecting member (not shown). In one embodiment, the deep convex insertion portion 14 may be configured to include 10 radially extending members 28.

[0035] The convexity characteristics for achieving a desired balance of depth, flexibility, and pliability while maintaining the integrity of the deep convex insert 14, and for applying sufficient pressure to the periostomy skin, may be defined by a combination of depth range, convexity range, pliability range, and compressibility range. Furthermore, it has been found that the ratio of the dome thickness 46 to the hoop thickness 48 (Figure 10) can be an important component to consider when constructing a deep convex insert 14 having a target combination of depth, gradient, flexibility, and pliability that can still maintain integrity without collapsing when pressure is applied to the periostomy skin.

[0036] The depth D of the deep convex insertion portion 14 is measured from the body-side surface of the base portion 22 to the apex of the deep convex insertion portion 14, as shown in Figure 10.

[0037] The convex gradient Θ is the gradient of the tangent line T to the body-side surface 44, measured at half (1 / 2) the depth (D) of the convex insertion portion 14.

[0038] The "flexibility" of an ostomy barrier appliance, such as a convex ostomy barrier appliance 10 or a deep convex insertion part 14, can be quantified by measuring its compressibility. Compressibility may be measured as a compressive resistance value in energy units such as N·mm, calculated as the area under the force-displacement curve. To measure compressive resistance, the ostomy barrier appliance may be placed flat with the pouch-facing side down, and a force may be applied to the convex part of the ostomy barrier appliance. The energy required to displace or compress the convex part by a predetermined distance may be measured as the compressive resistance value. The compressive resistance values ​​disclosed herein are measured according to the compressibility test method described and referenced herein, which measures the force required to compress the convex part of the ostomy barrier appliance by a certain distance. The test method is performed using a tensile testing machine such as an MTS tensile testing machine.

[0039] Figure 11 shows an example of a tensile testing machine 110 configured to perform a compressibility test method for measuring the compressive 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 fixing plates 116 positioned on the base platen 112, a load cell 118, a platen insertion section 120, and one or more fixing pins 122.

[0040] Figure 12 is a perspective view of the base platen 112 and 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 a fixing plate 116 to the base platen 112. The fasteners 124 may be, for example, bolts, pins or other known suitable fasteners, or a combination 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 the base of a tensile testing machine 110.

[0041] Figure 13 shows examples of fixing plates 116 of different sizes according to one embodiment. Each fixing plate 116 may be two plates that are substantially mirror images of each other. For example, each fixing plate 116 may include a first piece 128 and a second piece 130. Each piece 128, 130 may include one or more plate fastening holes 132 and a semicircular opening 134. The fixing plate 116 may be of various sizes depending on the diameter of the semicircular opening 134. The semicircular opening 134 may be sized to correspond to ostomy barrier appliances of various sizes. For example, the semicircular opening 134 may correspond to the size (diameter) of the convex portion 15 of the convex ostomy barrier appliance 10 or convex insertion portion 14 being tested. Therefore, the fixing plate 116 may be configured to restrain the radially outer portion of the ostomy barrier appliance, such as the outer flange 16 of the convex ostomy barrier appliance 10 or the base 22 of the convex insertion portion 14, without restraining the convex portion.

[0042] Figure 14 shows an example of a load cell 118 according to one embodiment. The load cell 118 or load cell end effector may be an upper fixture on the tensile testing machine 110, i.e., mounted above the base platen 112 and configured to move toward the base platen 112 along the vertical axis during the compressibility test. The load cell 118 may have a width of 5 mm at the contact end 136 configured to compress the protrusion 15 of the ostomy barrier appliance 10 during the compressibility test. The load cell 118 may be mounted on the tensile testing machine 110 using two load cell fasteners 138 to maintain radial alignment.

[0043] Figure 15 shows examples of platen insertion sections 120 of different sizes. Each platen insertion section 120 may include a plurality of platen insertion section fastening openings 140 and openings 142. The openings 142 may be circular openings, and the platen insertion sections 120 of different sizes may be of various sizes depending on the diameter of the openings 142. Platen insertion sections 120 of different sizes, i.e., platen insertion sections 120 having openings 142 of different sizes, may be used to test ostomy barrier appliances of different sizes. In one embodiment, the openings 142 may be sized to accommodate the connecting flanges of ostomy barrier appliances of different sizes.

[0044] Figure 16 shows an example of a fixing pin 122. The fixing pin 122 may be configured to fix the fixing plate 116 to the platen insertion portion 120. In one embodiment, four fixing pins 122 may be used so that the first piece 128 and the second piece 130 of the fixing plate 116 are fastened to the platen insertion portion 120 using two fixing pins 122 each. The fixing pins 122 may extend, for example, into or through one or more platen insertion fastening openings 140 and one or more aligned support plate fastening holes 132. Each fixing pin 122 may include a shaft 144 and a removable spring 146 on the shaft 144, so that the fixing spring 122 can accommodate ostomy barrier appliances of different heights.

[0045] Figure 17 shows a convex ostomy barrier appliance 10 positioned on a tensile testing machine 110 during setup for a compressibility test, according to one embodiment. The platen insertion section 120 may be selected based on the size of the convex ostomy barrier appliance 10 to be tested. The platen insertion section 120 may be positioned on and / or attached to the base platen 112. The convex ostomy barrier appliance 10 may be positioned on the platen insertion section 120 such that the convex portion 15 is substantially aligned with the opening 142 and extends over or across the opening 142. The fixing plate 116 may also be selected based on the size of the convex ostomy barrier appliance 10 to be tested. The first piece 128 of the fixing plate 116 may be positioned on a portion of the outer flange 16. The semicircular opening 134 of the first piece 128 may be fitted onto the periphery of the convex portion 15. Although not shown in Figure 17, it is understood that the second piece 130 of the fixing plate 116 may be positioned on another portion of the outer flange 16, and the semicircular opening 134 of the second piece 130 may be fitted onto another periphery of the protrusion 15. This allows the body-facing protrusion 15 of the ostomy barrier appliance 10 to be exposed at the semicircular opening 134. At least a portion of the outer flange 16 may be positioned between the first piece 128 and the platen insertion portion 120, and between the second piece 128 and the platen insertion portion 120. In this way, the ostomy barrier appliance 10 may be held for compressibility testing.

[0046] Figure 18 is a side view of the ostomy barrier appliance 10 positioned on a tensile testing machine 110 during a compressive test. In one embodiment, the first piece 128 and the second piece 130 of the fixing plate 116 may be positioned on 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 insertion portion 120 by fixing pins 122. The protrusion 15 of the ostomy barrier appliance 10 may be positioned in the semicircular openings 134 of the first piece 128 and the second piece 130, and therefore may be exposed. The contact end 136 of the load cell 118 may be moved to contact the protrusion 15 during the compressive test.

[0047] The ostomy barrier appliance 10 may be prepared for compressibility testing by removing the release liner and replacing it with a lint-free wipe such as KIMWIPE®. The ostomy barrier appliance 10 may be positioned on the platen insertion section 120 in the manner described above. The fixing plate 116 is configured to restrain the peripheral portion of the ostomy barrier appliance 10 around the protrusion 15, for example, the outer flange 16, without contacting the protrusion 15, thereby simulating how the ostomy barrier appliance 10 is restrained by the user. The load cell 118 may be lowered and contact the protrusion 15, applying a preload of approximately 0.4 N.

[0048] The load cell 118 may be controlled to move at a speed of 5 inches per minute to compress the protrusion 15. The load cell 118 may also move with a fixed displacement of 3.0 mm (approximately 0.118 inches). The tensile testing machine 110 may include, or be operably connected to, a computer configured to run software for recording and / or calculating basic statistics during the compressibility test. For example, the tensile testing machine 110 may record the forces applied to the load cell 118 at various displacements during the flexibility test method using the computer. The tensile testing machine 110 may also determine other information in the computer, such as the mean, minimum, maximum, standard deviation, and coefficient of variation % of the recorded values. The tensile testing machine 110 may also calculate the energy (area under the force-displacement curve) for displacements of 0-1 mm, 1-2 mm, and 2-3 mm. Furthermore, the tensile testing machine 110 may calculate or record the compressive force at a displacement of 3 mm and / or the compressive distance at a force of 5 N. It is understood that the computer for running software for recording and / or calculations may be part of the tensile testing machine 110, or may be 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.

[0049] Compression tests may be performed on ostomy barrier appliances of different sizes. For example, compression tests may be performed on ostomy barrier appliances with a connecting flange inner diameter of 1.75 inches, a connecting flange inner diameter of 2.25 inches, and a connecting flange inner diameter of 2.75 inches (also referred to in this disclosure as “small,” “medium,” and “large” appliances). Compression tests may be performed on the convex insert of those ostomy barrier appliances, or on the convex insert of other two-piece ostomy barrier appliances having a similar convex insert, which may differ in size from the examples above. In such cases, the tensile testing machine 110 and its associated components may be fitted as tightly as possible to provide a substantially similar testing environment so that the test results can be reliably compared.

[0050] The flexibility of an ostomy barrier appliance may be quantified by measuring the bending resistance of an ostomy barrier appliance positioned vertically, i.e., with its diameter on the vertical axis, when a compressive force is applied to the ostomy barrier appliance on the vertical axis. Flexibility may be measured as an energy unit such as N·mm calculated as the area under the force-displacement curve. That is, in this disclosure, flexibility may be measured as the energy expended to deform the ostomy barrier appliance by a predetermined amount. For example, flexibility may refer to the energy expended to deform a vertically positioned ostomy barrier appliance 10 by 30%, i.e., to reduce the height of the vertically positioned ostomy barrier appliance 10 by 30% due to the application of a compressive force.

[0051] Figures 19 to 30 illustrate a test apparatus and method for testing the flexibility of an ostomy barrier appliance, such as a convex ostomy barrier appliance 10 or a convex insert 14, as described and referred to herein as a flexibility test method. Figure 19 shows a portion of a tensile testing machine 210 for performing a flexibility test method according to one 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. A lower platen insert 218 may be attached to the lower platen 218. To perform the flexibility test method, the upper platen 212 may be moved toward the lower platen 214, or vice versa. The tensile testing machine 210 may include test operation software or equivalent, or may be operably connected to a computing device having test operation software or equivalent. The tensile testing machine 210 may provide a constant transverse speed as one platen moves toward the other.

[0052] Figure 20 shows an ostomy barrier appliance 10 positioned on a tensile testing machine 210 for performing a flexibility test. The ostomy barrier appliance 10 may be prepared such that injection-molded portions, such as connecting flanges 22, are positioned in contact with platen insertion portions 216, 218.

[0053] Figures 21 and 22 show examples of ostomy barrier appliances 10 prepared for flexibility testing. In one embodiment, the outer flange 16 may be trimmed as indicated by the cutting line 220 in order to prepare the ostomy barrier appliance 10 for flexibility testing. Thus, as described above, injection-molded portions such as the connecting flange 22 or the deep convex insert 26 may be positioned on or near the edge of the ostomy barrier appliance 10 for flexibility testing. The ostomy barrier appliance 10 to be tested should be kept flat during preparation to avoid bending or wrinkling.

[0054] Figure 23 is a plan view of the ostomy barrier appliance 10 after trimming for flexibility testing. As shown in Figure 23, the cutting line 220 and associated trimming result in two substantially parallel horizontal edges 222 extending tangentially to the 12 o'clock and 6 o'clock positions of the connecting flange 22. If the ostomy barrier appliance for flexibility testing is a single-piece product, the ostomy pouch may also be removed from the sample for testing, for example, by cutting.

[0055] Figure 24 is an enlarged view of a positioning groove 224 according to one embodiment. The lower platen insertion portion 216 and the upper platen insertion portion 218 may each include a 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 the second length. In one embodiment, the first portion 226 may have a first slope, and the second portion 228 may have a second slope. The absolute value of the first slope may be less than the absolute value of the second slope. The positioning slot 224 may have a width "w" and a depth "d". The valley (i.e., the tip of the maximum depth) may be offset from the center in the width "w" direction. The first portion 226 may extend along the surface of the positioning groove 224 in the width "w" direction from the valley to one end of the positioning groove 224. The second portion 228 may extend in the width "w" direction along the surface of the positioning groove 224 from the valley to the other end of the positioning groove 224. The positioning groove 224 may be sized and shaped to facilitate bending of the ostomy barrier appliance 10 in a predetermined direction during flexibility testing. For example, the size and shape of the positioning groove 224 may facilitate bending of the ostomy barrier appliance to the right in Figure 24.

[0056] Figures 25-27 show examples of ostomy barrier appliances 10 positioned in a tensile testing machine 210 for flexibility testing. As shown in Figure 25, the trimmed horizontal edge 222 may be positioned in the respective positioning slots 224 of the upper platen insertion section 216 and the lower platen insertion section 218. In Figure 26, the position of the ostomy barrier appliance 10 may be adjusted laterally with respect to the upper platen insertion section 216 and the lower platen insertion section 218 so that compressive forces from the tensile testing machine 210 can be applied to specific positions of different ostomy barrier appliances for different flexibility tests. For example, the ostomy barrier appliance 10 may be approximately centered laterally between the upper and lower platen insertion sections. Referring to Figures 26 and 27, the ostomy barrier appliance 10 may include a first position mark 230 and a second position mark 232. The first position mark 230 and the second position mark 232 may be located at 0 degrees and 180 degrees (12 o'clock and 6 o'clock), respectively. The upper platen insertion section 216 and the lower platen insertion section 218 may also include a third position mark 234 and a fourth position mark 236, respectively. When the first position mark 230 is substantially aligned with the third position mark 234 and the second position mark 232 is substantially aligned with the fourth position mark 236, the ostomy barrier appliance 10 may be appropriately positioned relative to the upper platen insertion section 216 and the lower platen insertion section 218.

[0057] Figure 28 is a partial perspective view of a tensile testing machine 210 having an ostomy barrier appliance 10 arranged for flexibility testing according to one embodiment. As described above, the trimmed horizontal edge 222 of the ostomy barrier appliance 10 may be positioned within the positioning grooves 224 of the upper platen insertion section 216 and the lower platen insertion section 218, respectively. In one embodiment, the release liner may be removed from the protrusion 14 of the ostomy barrier appliance and a lint-free wipe may be placed on top of the adhesive.

[0058] Figure 29 shows an ostomy barrier appliance 10 in a tensile testing machine 210 during a flexibility test, bent in a desired manner for flexibility measurement according to one embodiment. As shown in Figure 29, the desired bending pattern of the ostomy barrier appliance 10 may include the connecting flange 22 bending toward the body-facing side of the ostomy barrier appliance 10 (or to the right, as shown in Figure 29).

[0059] Figure 30 shows an example of an ostomy barrier appliance 10 exhibiting an unintended bending pattern during a flexibility test. For example, an unintended bending pattern may include the connecting flange 22 bending toward the pouch-facing side (or to the left as shown in Figure 30). In such cases, measurements should not be recorded to determine the flexibility of the ostomy barrier appliance 10.

[0060] The tensile testing machine 210 may be operated to apply a compressive force to the ostomy barrier appliance 10 positioned between the upper platen insertion section 216 and the lower platen insertion section 218 as described above, for example, by moving one of the platen insertion sections toward the other. Functional components, such as the diameter or height of the connecting flange 22 and / or convex insertion section 14, may be provided to the tensile testing machine 210. For example, the diameter or height may be provided to a computer having software that controls the operation of the tensile testing machine 210 to perform a flexibility test. The diameter or height may be measured, for example, using a caliper or ruler, or it may refer to the distance between the opposing edges of the connecting flange 22 and / or convex insertion section 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 it may be a peripheral device operably connected to the tensile testing machine.

[0061] Other information regarding the ostomy barrier appliance being tested may also be provided to the tensile testing machine 210. For example, groove depth and / or flexibility test parameters such as initial speed, strain termination point, and data acquisition speed can be provided to the computer. In one embodiment, the initial speed (i.e., the speed of the platen supplying the compressive force) may be about 10 inches / min, the strain termination point may be about 0.5 inches / inch, and the data acquisition speed may be about 10.0 Hz.

[0062] In one embodiment, the tensile testing machine 210 may be operated to pre-bend the ostomy barrier appliance 10 by applying a preload to it. The pre-bending may be defined in the software that controls the flexibility test, and may have a default value of, for example, 2% of the diameter of the functional part of the ostomy barrier appliance 10.

[0063] The computer may record and / or calculate various parameters during the flexibility test. Calculations may be performed according to software run by the computer, for example, software specific to the tensile testing machine 210. Exemplary calculations include the pre-bending force (N) at -2% strain (a static force measurement useful for determining whether the ostomy barrier appliance is properly positioned in the upper and lower platen insertions), the energy at -30% strain (N·mm) (which may be the definite integral from elongation 0 mm to 30% of the total diameter or total height of the functional part as a function of load (N), or the "area under the curve" of the force measurement from elongation = 0 mm to 30% of the total height (mm) of the functional part), and / or the energy at -X% strain (N·mm) (the same as above, but for output of an alternative test method if other strain % measurements are specified in the test protocol). Flexibility data may be reported as the "energy at -30% strain" (N·mm) measurement. A minimum of three measurements may be performed for each 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 one embodiment, the load cell of the tensile testing machine 210 may be a 50N load cell. The flexibility test may be performed on ostomy barrier appliances of different sizes, such as the small, medium, and large sizes described above. The flexibility test may be adapted to other ostomy barrier appliances of different sizes than those described above in order to obtain consistent results for reliable comparison of flexibility and / or compressibility.

[0064] Samples of deep convex inserts 14 having the desired balance of flexibility and compressibility were tested according to the compressibility and flexibility test methods described above to quantify the convex shape characteristics. For compressive characteristics, the compressive resistance value and standard deviation based on the average energy up to 3 mm were recorded. For flexibility characteristics, the energy of -30% strain was recorded for each deep convex insert sample. As used herein, "-30% strain energy" refers to the energy expended to deform the deep convex insert by 30%. The energy expended to deform an object by X% is the amount of work done on the object to deform it by X%, and this is the "area under the curve" of the force measurement from elongation = 0 mm to X% of the total height (mm) of the object. JPEG2026516771000002.jpg4287

[0065] For flexibility testing, each deep convex insertion sample was prepared and placed on a tensile testing machine 210 according to the flexibility testing method. A 50N load cell was used on the tensile testing machine 210. The settings used on the tensile testing machine were: initial speed (i.e., speed of the platen providing compressive force) -10 inches / min, strain termination point -0.5 inches / inch, and data acquisition speed -10.0 Hz. The compressive force applied to the deep convex insertion sample as the upper platen moved downward toward the lower platen was recorded from the initial position of the ostomy barrier sample (X=0) to -30% of the ostomy sample height (X=m). The area under the force measurement curve was calculated to obtain the energy of the deep convex insertion sample at -30% strain.

[0066] In one embodiment, the deep convex insertion portion 14 may be configured such that the depth D is about 6 mm to about 15 mm, preferably about 8 mm to about 13 mm, more preferably about 9 mm to about 11 mm, the convex slope Θ is about 25° to about 85°, preferably about 30° to about 80°, more preferably about 65° to about 75°, the flexibility measured by the energy expended to deform the deep convex insertion portion by 30% according to a flexibility test method is 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 the compressibility measured by the energy expended to compress the convex portion 15 of the deep convex insertion portion by 3 mm according to a compressibility test method is 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 embodiments, the deep convex insertion portion 14 may be configured such that the ratio of the dome thickness 46 to the hoop thickness 48 is 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 about 0.4:1.0 to about 0.5:1.0. The dome thickness is the minimum cross-sectional thickness of the deep convex insertion portion 14 within the convex body-side portion 44, and the hoop thickness is the maximum cross-sectional thickness of the deep convex insertion portion 14 within the concave body-side portion 42. In embodiments, the convex slope Θ of the convex insertion portion 14 may vary based on the clinical application. The convex slope Θ may be in the range of about 15° to about 80°. For example, the convex slope Θ can be gentler, about 45°±10°, or it can be steeper, about 66°±10°.

[0067] In one embodiment, the deep convex insertion section 14 may be configured such that the depth D is approximately 9.5 mm, the convex slope Θ is approximately 72°, the flexibility is approximately 75 N·mm as measured by the energy required to deform the deep convex insertion section by 30% according to a flexibility test method, the compressibility is approximately 20 N·mm as measured by the energy required to compress the convex portion 15 of the deep convex insertion section by 3 mm according to a compressibility test method, and the ratio of the dome thickness 46 to the hoop thickness 48 is approximately 0.45:1.0. For example, the deep convex insertion section 14 may be configured such that the dome thickness 46 is approximately 1.75 mm and the hoop thickness is approximately 3.8 mm. In the embodiment shown in Figure 10, the thickness of the recess 42 of the deep convex insertion section 14 may decrease from the hoop thickness towards the dome thickness.

[0068] Figures 31 and 32 show a deep convex insertion section 414 according to one embodiment. Figure 31 is a body-side view of the deep convex insertion section 414, and Figure 32 is a distal view of the deep convex insertion section 414. The deep convex insertion section 414 may be configured to have similar convex shape characteristics to the deep convex insertion section 14 (e.g., depth, gradient, compressibility, flexibility, and ratio of dome thickness to hoop thickness), and may include an inner rim 418, an outer rim 420 (also referred to herein as a base), and an intermediate section including 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 extending radially within the convex dome section 466 and a plurality of short openings and / or grooves 472 within the concave intermediate section 464 of the deep convex insertion section 414.

[0069] In one embodiment, the plurality of openings and / or grooves 416 may include an equal number of long openings and / or grooves 470 and short openings and / or grooves 472, each of which the plurality of short openings and / or grooves 472 may be aligned with a corresponding long opening / groove 470, as shown in Figure 31. In such embodiments, each pair of radially extending, spaced-apart long openings / grooves 470 and short openings / grooves 472 may be configured to facilitate curving and bending of the ostomy barrier appliance including the deep convex insertion section 414 along the pair of long openings / grooves 470 and short openings / grooves 472. In the embodiments of Figures 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 insertion section 414, while each of the plurality of short openings / grooves 472 may be formed as a groove shallower than the thickness of the deep convex insertion section 414, such that the groove 472 does not extend through the entire thickness of the deep convex insertion section 414. In some embodiments, the multiple long openings and / or grooves 470 and the multiple short openings and / or grooves 472 may include only openings, only grooves, or a mixture of openings and grooves.

[0070] The deep-convex insertion sections 14 and 414 may be formed from suitable materials such as polymer materials, rubber, silicone, or metal materials. For example, the deep-convex insertion sections 14 and 414 may be formed from heat-fusible thermoplastic materials such as ethylene vinyl acetate (EVA) copolymer, thermoplastic elastomer, or thermoplastic urethane. In one embodiment, the deep-convex insertion sections 14 and 414 may be formed from an EVA copolymer having an elastic modulus of about 7400 psi and a durometer hardness of about 90 A, such as ELVAX®-450 available from Dow.

[0071] All patents referenced herein, whether or not they are specifically mentioned herein, are incorporated herein in their entirety by reference.

[0072] In this disclosure, the words "a" or "an" should be interpreted as including both singular and plural forms. Conversely, references to multiple items should include the singular form where appropriate.

[0073] From the above, it will be observed that numerous modifications and variations can be achieved without departing from the true spirit and scope of the novel concepts of this disclosure. It should be understood that no limitations are intended and should not be assumed with respect to any particular embodiment shown in the illustrations. This disclosure is intended to be exhaustive, by the appended claims, so that all such modifications are included within the scope of the claims.

Claims

1. A convex ostomy barrier appliance for attaching an ostomy pouch to the periostomy skin surrounding the stoma, A skin barrier portion including adhesive, A convex insertion portion is attached to the distal side of the skin barrier portion and defines the shape of the convex portion of the convex ostomy barrier appliance, An inlet opening for receiving the stoma, Equipped with, The convex insertion portion includes a base and a convex dome, and is configured such that it has a depth of approximately 6 mm to approximately 15 mm, a convex slope of approximately 25° to approximately 85°, a flexibility of approximately 50 N·mm to approximately 125 N·mm, and a compressibility of approximately 10 N·mm to approximately 40 N·mm, wherein the depth is measured from the body-side surface of the base to the apex of the deep convex insertion portion, the convex slope is the slope of the tangent to the body-side surface measured at a position half the depth of the convex insertion portion, the flexibility is measured by the energy expended to deform the deep convex insertion portion by 30% according to a flexibility test method, and the compressibility is measured by the energy expended to compress the convex dome of the convex insertion portion by 3 mm according to a compressibility test method. Convex ostomy barrier appliance.

2. The convex ostomy barrier appliance according to claim 1, wherein the convex insertion portion comprises a plurality of radially extending members configured to define and support the shape of the convex portion, each of the plurality of radially extending members being separated from adjacent radially extending members by a gap, and each of the radially extending members being configured to bend independently in accordance with the force applied to each of the radially extending members when the skin barrier portion is pressed against the user's ostomy-peripheral skin.

3. The convex ostomy barrier appliance according to claim 2, wherein the convex insertion portion further comprises an intermediate portion connecting the convex dome and the base, and the convex dome is formed by the plurality of radially extending members.

4. The convex ostomy barrier appliance according to claim 1, wherein the convex insertion portion comprises an inner rim, a base, and an intermediate portion extending between the inner rim and the base, the intermediate portion including a convex dome, a recess, and a plurality of openings and / or grooves, the plurality of openings and / or grooves including a plurality of long openings and / or grooves extending radially within the convex dome and a plurality of short openings and / or grooves within the recess.

5. The convex ostomy barrier appliance according to claim 4, wherein the plurality of openings and / or grooves include an equal number of long openings and / or grooves and short openings and / or grooves, 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 openings / grooves and short openings / grooves, each of the pairs of long openings / grooves and short openings / grooves extends radially and is spaced apart from adjacent pairs of long openings / grooves and short openings / grooves, and is configured to facilitate curving and bending of the convex ostomy barrier appliance along the pairs of long openings / grooves and short openings / grooves.

6. The convex ostomy barrier assembly according to claim 4 or 5, wherein each of the plurality of long openings and / or grooves is an opening that extends through the thickness of the deep convex insertion portion, and each of the plurality of short openings and / or grooves is a groove shallower than the thickness of the deep convex insertion portion, such that it does not extend through the entire thickness of the deep convex insertion portion.

7. The convex insertion portion is configured to have a depth of approximately 8 mm to approximately 13 mm, a convex slope of approximately 30° to approximately 80°, a flexibility of approximately 60 N·mm to approximately 100 N·mm, and a compressibility of approximately 15 N·mm to approximately 25 N·mm, as described in any one of claims 1 to 6.

8. The convex insertion portion is configured to have a depth of approximately 9 mm to approximately 11 mm, a convex slope of approximately 65° to approximately 75°, a flexibility of approximately 70 N·mm to approximately 80 N·mm, and a compressibility of approximately 17 N·mm to approximately 23 N·mm, as described in any one of claims 1 to 6.

9. The convex insertion portion is configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.2:1.0 to approximately 0.6:1.0, the dome thickness is the minimum cross-sectional thickness of the deep convex insertion portion in the convex dome, and the hoop thickness is the maximum cross-sectional thickness of the convex insertion portion in the concave body-side portion, according to any one of claims 1 to 8.

10. The convex ostomy barrier appliance according to any one of claims 1 to 8, wherein the convex insertion portion is configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.3:1.0 to approximately 0.5:1.0, the dome thickness being the minimum cross-sectional thickness of the convex insertion portion in the convex dome, and the hoop thickness being the maximum cross-sectional thickness of the convex insertion portion in the concave body-side portion.

11. The convex ostomy barrier appliance according to any one of claims 1 to 8, wherein the convex insertion portion is configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.4:1.0 to approximately 0.5:1.0, the dome thickness is the minimum cross-sectional thickness of the convex insertion portion in the convex dome, and the hoop thickness is the maximum cross-sectional thickness of the convex insertion portion in the concave body-side portion.

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

13. The convex ostomy barrier appliance according to any one of claims 1 to 12, wherein the convex insertion portion is formed from an ethylene vinyl acetate copolymer having an elastic modulus of approximately 7400 psi and a durometer hardness of approximately 90 A.

14. The convex insertion portion is configured to have a depth of approximately 9.5 mm, a convex slope Θ of approximately 72°, a flexibility of approximately 75 N·mm, a compressibility of approximately 20 N·mm, and a ratio of dome thickness to hoop thickness of approximately 0.45:1.0, as described in any one of claims 1 to 13.

15. The convex ostomy barrier appliance according to any one of claims 1 to 7, wherein the slope of the convex portion is 45° ± 10°.

16. The convex ostomy barrier appliance according to any one of claims 1 to 13, wherein the slope of the convex portion is 66° ± 10°.

17. A convex insertion part comprising a base that defines the body surface and a convex dome, The convex insertion portion has a depth of approximately 6 mm to approximately 15 mm, a convex slope of approximately 25° to approximately 80°, a flexibility of approximately 50 N·mm to approximately 125 N·mm, and a compressibility of approximately 10 N·mm to approximately 40 N·mm, wherein the depth is measured from the body-side surface of the base to the apex of the convex insertion portion, the convex slope is the slope of the tangent to the body-side surface measured at a position half the depth of the convex insertion portion, the flexibility is measured by the energy expended to deform the convex insertion portion by 30% according to a flexibility test method, and the compressibility is measured by the energy expended to compress the convex dome of the convex insertion portion by 3 mm according to a compressibility test method.

18. The convex insertion portion according to claim 17, wherein the convex insertion portion is configured to have a depth of approximately 8 mm to approximately 13 mm, a convex slope of approximately 30° to approximately 80°, a flexibility of approximately 60 N·mm to approximately 100 N·mm, and a compressibility of approximately 15 N·mm to approximately 24 N·mm.

19. The convex insertion portion according to claim 17 or claim 18, wherein the convex insertion portion is configured to have a depth of approximately 9 mm to approximately 11 mm, a convex slope of approximately 65° to approximately 75°, a flexibility of approximately 70 N·mm to approximately 80 N·mm, and a compressibility of approximately 17 N·mm to approximately 23 N·mm.

20. The convex insertion portion is configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.2:1.0 to approximately 0.6:1.0, the dome thickness is the minimum cross-sectional thickness of the convex insertion portion in the convex dome, and the hoop thickness is the maximum cross-sectional thickness of the convex insertion portion in the concave body side portion, according to any one of claims 17 to 19.

21. The convex insertion portion is configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.3:1.0 to approximately 0.5:1.0, the dome thickness is the minimum cross-sectional thickness of the convex insertion portion in the convex dome, and the hoop thickness is the maximum cross-sectional thickness of the convex insertion portion in the concave body side portion, according to any one of claims 17 to 20.

22. The convex insertion portion is configured such that the ratio of the dome thickness to the hoop thickness is approximately 0.4:1.0 to approximately 0.5:1.0, the dome thickness is the minimum cross-sectional thickness of the convex insertion portion in the convex dome, and the hoop thickness is the maximum cross-sectional thickness of the convex insertion portion in the concave body side portion, according to any one of claims 17 to 21.

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

24. The convex insertion portion according to any one of claims 17 to 23, wherein the convex insertion portion is formed from an ethylene vinyl acetate copolymer having an elastic modulus of about 7400 psi and a durometer hardness of about 90 A.

25. The convex insertion portion according to any one of claims 17 to 24, wherein the convex insertion portion is formed from an ethylene vinyl acetate copolymer having an elastic modulus of about 7400 psi and a durometer hardness of about 90 A.

26. The convex insertion portion according to any one of claims 17 to 25, wherein the convex insertion portion is configured to have a depth of approximately 9.5 mm, a convex slope of approximately 72°, a flexibility of approximately 75 N·mm, a compressibility of approximately 20 N·mm, and a ratio of the dome thickness to the hoop thickness of approximately 0.45:1.

0.

27. The convex insertion portion according to claim 17 or claim 18, wherein the slope of the convex portion is 45° ± 10°.

28. The convex insertion portion according to any one of claims 17 to 25, wherein the slope of the convex portion is 66° ± 10°.

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