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WO2025101759A1 - Appareil de barrière de stomie ayant une convexité réglable douce - Google Patents

Appareil de barrière de stomie ayant une convexité réglable douce Download PDF

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Publication number
WO2025101759A1
WO2025101759A1 PCT/US2024/054933 US2024054933W WO2025101759A1 WO 2025101759 A1 WO2025101759 A1 WO 2025101759A1 US 2024054933 W US2024054933 W US 2024054933W WO 2025101759 A1 WO2025101759 A1 WO 2025101759A1
Authority
WO
WIPO (PCT)
Prior art keywords
convexity
adjusting device
depth
ostomy barrier
appliance
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/054933
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English (en)
Inventor
Gregory J. Czaplewski
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Hollister Inc
Original Assignee
Hollister Inc
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Filing date
Publication date
Application filed by Hollister Inc filed Critical Hollister Inc
Publication of WO2025101759A1 publication Critical patent/WO2025101759A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type seals, e.g. gels, starches, karaya gums
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F2005/4483—Convex pressure ring

Definitions

  • ostomy appliances More particularly, ostomy barrier appliances having gentle adjustable convexity.
  • Ostomy pouches for collecting bodily waste are used by individuals who have had surgery such as a colostomy, ileostomy, or urostomy.
  • An ostomy pouch may be secured to a user via an ostomy barrier appliance that seals around the stoma and attached to the peristomal skin surface and protect the peristomal surface from exposure to stomal effluent.
  • an ostomy barrier appliance that seals around the stoma and attached to the peristomal skin surface and protect the peristomal surface from exposure to stomal effluent.
  • 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 remain as an area for further improvements.
  • a stoma may protrude more or less, or may even be flush or recessed.
  • Convex ostomy barrier appliances such as a convex base plate including a convex insert, may be used in instances where the stoma is retracted or sunken into the user’s body.
  • the convex base plate may apply pressure to the user’s body in the area surrounding the stoma in such a way that the stoma may project outward and be received through a stoma opening defined in the convex base plate.
  • some conventional convex base plates can be relatively stiff, inflexible and do not conform to user’s body well, and thus, users often find them uncomfortable.
  • Soft convex base plates have been developed to improve user comfort. Some soft convex base plates may have a higher degree of flexibility than “firm” convex base plates.
  • ostomates with hernia having bulging peristomal area typically stayed away from convex ostomy barrier appliances as the convexity of the ostomy barrier do not conform to the bulging peristomal skin area.
  • some ostomates may have complex peristomal topography. For example, an ostomate may have a bulging peristomal topography in one area and a depressed peristomal topography in another area.
  • An ostomy barrier appliance configured to allow a sectional convexity adjustment from a positive convexity depth to a negative convexity depth to conform to user’s peristomal topography is provided according to various embodiments.
  • an ostomy barrier appliance for attaching an ostomy pouch appliance to a peristomal skin surrounding a stoma may include a skin barrier comprising an adhesive, a convexity adjusting device attached to a distal side of the skin barrier to define a convexity of the ostomy barrier appliance, and an inlet opening for receiving the stoma.
  • the convexity adjusting device may be configured for an adjustment of the convexity of the ostomy barrier appliance from a first positive convexity depth to a second convexity depth as the ostomy barrier appliance conforms to user’s peristomal topography when applied to a user.
  • the convexity adjusting device may be configured to adjust the convexity of the ostomy barrier appliance automatically, without user’s manual intervention, in response to the amount of force applied by the user’ peristomal topography pushing back against portions of the convexity adjusting device, such as a dome portion defined by a plurality of petal-like members.
  • the second convexity depth may be a second positive convexity depth, a zero convexity depth, or a negative convexity depth, wherein the first or second positive convexity depth provides an ostomy barrier appliance that protrudes toward the user, the zero convexity depth provides a generally flat ostomy barrier appliance, and the negative convexity depth provides an inverted ostomy barrier appliance that protrudes away from the user.
  • the convexity adjusting device may be configured to automatically adjust a convexity slope of the ostomy barrier appliance as a dome portion of the convexity adjusting device is pressed down in response to the force applied by the user’s peristomal topography.
  • the convexity adjusting device may be configured for local adjustments of the convexity slope from about 55° +/- 10° (the starting slope) to about 0° (when pressed flat) to about -60° (when inverted).
  • Such convexity slope adjustments may be made possible by providing a dome portion defined by a plurality of petal-like members that can pivot and invert independently.
  • the convexity adjusting device may be configured to automatically adjust a tension location of the ostomy barrier appliance in response to the force applied by the user’s peristomal topography.
  • An initial tension location (starting tension location) of the ostomy barrier appliance may define the tension location closest to the stoma, wherein the tension location may be moved out peripherally as the convexity adjusting device pivots and/or inverts in response to the force applied by the user’s peristomal topography.
  • the ostomy barrier appliance may be initially provided including a convex skin barrier having the first positive convexity depth and configured for a sectional convexity depth adjustment as the ostomy barrier appliance conforms to user’s peristomal topography when applied to a user.
  • the ostomy barrier appliance may be configured for the sectional convexity depth adjustment from the first positive convexity depth to a second negative convexity depth in a first section corresponding to user’s first peristomal area having a protruding convex peristomal topography, and the sectional convexity depth adjustment from the first positive convexity depth to the zero convexity depth in a second section corresponding to user’s second peristomal area having a generally flat peristomal topography.
  • the ostomy barrier appliance may be configured for the sectional convexity depth adjustment from the first positive convexity depth to a second positive convexity depth in a first section corresponding to user’s first peristomal area having a sunken depressed peristomal topography, and the sectional convexity depth adjustment from the first positive convexity depth to a second negative convexity depth in a second section corresponding to user’s second peristomal area having a protruding convex peristomal topography.
  • the ostomy barrier appliance may be configured for the sectional convexity depth adjustment from the first positive convexity depth to a second negative convexity depth in a first section corresponding to user’s first peristomal area having a protruding convex peristomal topography, and the sectional convexity depth adjustment from the first positive convexity depth to a second positive convexity depth in a second section corresponding to user’s second peristomal area having a sunken depressed peristomal topography, and the sectional convexity depth adjustment from the first positive convexity depth to the zero convexity depth in a third section corresponding to user’s third peristomal area having a generally flat peristomal topography.
  • the convexity adjusting device may be configured for the convexity depth adjustment from the first positive convexity depth of about 6 mm to the second convexity depth (D2), wherein -6 mm ⁇ D2 ⁇ 6 mm, wherein the convexity depth is measured from a body side surface of a base of the convexity adjusting device to an apex of the convexity adjusting device.
  • the convexity adjusting device may be configured for a convexity slope adjustment from about 50° to about -50°, wherein the convexity slope is a maximum slope measured on a body side surface of the convexity adjusting device.
  • the convexity adjusting device may also be configured to have a flexibility of about 20 N*mm to about 30 N*mm, wherein the flexibility is measured in energy expended to deform the convexity adjusting device by 30% according to the flexibility test method, and a compressibility of about 5 N*mm to about 10 N*mm, wherein the compressibility is measured in energy expended to compress 3 mm of a convex dome of the convexity adjusting device according to the compressibility test method.
  • the convexity adjusting device may be provided as a convex device having the first positive convexity depth of about 6.5 mm to 7 mm, wherein the convexity depth is measured from a body side surface of a base of the convex device to an apex of the convex device, a convexity slope of about 50°, wherein the convexity slope is a maximum slope measured on the body side surface of the convexity adjusting device, a flexibility of about 25 N*mm, wherein the flexibility is measured in energy expended to deform the convexity adjusting device by 30% according to the flexibility test method, and a compressibility of about 7 N*mm, wherein the compressibility is measured in energy expended to compress 3 mm of a convex dome of the convexity adjusting device according to the compressibility test method.
  • the convexity adjusting device may include a plurality of radially extending members configured to define and support the convexity.
  • Each of the plurality of radially extending members may be separated from an adjacent radially extending member by a gap and configured to be flexed independently according to a force applied to each of the radially extending member as the skin barrier is pressed against the user’s peristomal skin.
  • the convexity adjusting device may include a convex dome, a base, and a middle portion connecting the convex dome and the base, wherein the convex dome is formed by the plurality of radially extending members.
  • Each of the plurality of radially extending members may be configured for flexing, moving and inverting independently to adjust a convexity depth of the corresponding portion of the convexity adjusting device according to the corresponding peristomal topography.
  • the convexity adjusting device may be configured to allow the plurality of radially extending members to flex, move and invert independent of the middle portion and base.
  • the convexity adjusting device may be configured to allow the plurality of radially extending members and the middle portion to flex, move and invert independent of the base.
  • each of the plurality of radially extending members may have a petal-like shape extending from the middle portion.
  • the convexity adjustment device can provide a localized convexity adjustment, wherein each of the plurality of radially extending members can locally adjust the corresponding convexity.
  • each of the plurality of radially extending members can locally adjust the corresponding convexity.
  • the individual positions around the convex dome inherently influence one another because the convex insert is formed as one continuous ring-ring device without gaps/breaks therein.
  • the convexity adjustment device including the plurality of radially extending members e.g. petal-like members
  • the convexity adjusting device may include a convex member and a plurality of beam members.
  • the convex member may include the convex dome, the base, and a middle portion connecting the convex dome and the base.
  • Each of the plurality of beam members may extend radially and configured to be flexed independently to provide localized adjustment of the convexity.
  • Each of the plurality of beam members may comprise at least one hinge configured to facilitate flexing of the beam member.
  • the convexity adjusting device may be initially configured with each of the plurality of beam members extended away from the middle portion, wherein each of the plurality of beam members may be configured to be pressed to flex independently as the skin barrier is pressed against user’s peristomal skin.
  • each of the plurality of beam members may include a convex dome portion configured to match a convex body side contour of an adjacent dome area of the convex member.
  • the convexity adjusting device may be configured to have a ratio of a dome thickness to a hoop thickness of about 0.25: 1.0 to about 0.8: 1.0, wherein the dome thickness is a minimum cross sectional thickness of the convexity adjusting device in a convex dome portion, and the hoop thickness is a maximum cross sectional thickness of the convexity adjusting device in a concave body side portion.
  • the convexity adjusting device may be configured to have a pivot point proximate a base of the convexity adjusting device, wherein a dome and a middle portion of the convexity adjusting device are configured to surround a stoma when inverted to provide a funnel-like protection around the stoma.
  • the convexity adjusting device may be formed from an ethylene vinyl acetate copolymer.
  • the skin barrier may include a hydrocolloid adhesive and/or a silicone adhesive.
  • FIG. 1 is a perspective distal side view of an ostomy barrier appliance including a convexity adjusting device according to an embodiment with a portion removed to illustrate its layered structure;
  • FIGS. 2A - 2D are schematic cross-sectional views of the ostomy barrier appliance of FIG. 1 conformed to various peristomal topographies;
  • FIG. 3 is an illustration of a depth of a convex skin barrier appliance
  • FIG. 4 is an illustration of compressibility of a convex skin barrier appliance
  • FIG. 5 is an illustration of flexibility of a convex skin barrier appliance
  • FIGS. 6A and 6B are illustrations of tension locations of a convex skin barrier appliance
  • FIG. 7 is an illustration of a slope of a convex skin barrier appliance
  • FIG. 8 is a perspective body side view of a convexity adjusting device according to an embodiment
  • FIG. 10 is a cross sectional view of the convexity adjusting device of FIG. 8;
  • FIG. 11 shows an example of a tensile testing machine configured to measure compressibility of a convex ostomy barrier appliance
  • FIG. 12 is a perspective view of a base platen and an adapter for the tensile testing machine of FIG. 11 according to an embodiment
  • FIG. 13 shows examples of differently sized securement plates for the tensile testing machine of FIG. 11;
  • FIG. 14 shows an example of a load cell for the tensile testing machine of FIG. 11;
  • FIG. 16 shows examples of securement pins for the tensile testing machine of FIG. 11 ;
  • FIG. 17 shows an ostomy barrier appliance arranged on the tensile testing machine of
  • FIG. 11 during setup for a compressibility test according to an embodiment
  • FIG. 18 is a side view of an ostomy barrier appliance arranged on the tensile testing machine of FIG. 11 during a compressibility test according to an embodiment
  • FIG. 19 shows an example of a tensile testing machine configured to measure flexibility of an ostomy barrier appliance
  • FIG. 20 shows an ostomy barrier appliance arranged in the tensile testing machine of FIG. 19 according to an embodiment
  • FIG. 21 shows an example of an ostomy barrier appliance being prepared for a flexibility test according to an embodiment
  • FIG. 22 shows another example of an ostomy barrier appliance being prepared for a flexibility test according to an embodiment
  • FIG. 23 is a plan view showing an example of a trimmed ostomy barrier appliance for a flexibility test according to an embodiment
  • FIG. 24 is an enlarged view of a positioning groove in the tensile testing machine of FIG. 19 according to an embodiment
  • FIG. 25 shows an example of an ostomy barrier appliance being positioned in the tensile testing machine of FIG. 19 for a flexibility test according to an embodiment
  • FIG. 26 shows another example of an ostomy barrier appliance being positioned in the tensile testing machine of FIG. 19 for a flexibility test according to an embodiment
  • FIG. 27 shows another example of an ostomy barrier appliance being positioned in the tensile testing machine of FIG. 19 for a flexibility test according to an embodiment
  • FIG. 28 is a partial perspective view of the tensile testing machine of FIG. 19 with an ostomy barrier appliance arranged for a flexibility test according to an embodiment
  • FIG. 29 shows an ostomy barrier appliance in an intended bending pattern during a flexibility test according to an embodiment
  • FIG. 30 shows an ostomy barrier appliance in an unintended bending pattern during a flexibility test according to an embodiment
  • FIG. 31 is a perspective body side view of a convexity adjusting device according to an embodiment
  • FIG. 32 is a perspective distal side view of the convexity adjusting device of FIG. 31;
  • FIG. 33 is a partial cross sectional view of the convexity adjusting device of FIG. 31.
  • FIGS. 34 A-D are schematic cross sectional views of an ostomy barrier appliance according to an embodiment conforming to various peristomal topographies.
  • FIGS. 1 and 2A show an ostomy barrier appliance 10 according to an embodiment.
  • the ostomy barrier appliance 10 is shown with a portion removed and viewed from a pouch-facing side (also referred to herein as a distal side) to illustrate a layered construction of the ostomy barrier appliance 10.
  • FIG. 2A is a cross sectional view of the ostomy barrier appliance 10.
  • the ostomy barrier appliance 10 may generally include a tape 12, a skin barrier 18, a convexity adjusting device 14, and an inlet opening 16 for receiving a stoma.
  • the tape 12 may include a substrate layer 11 (also referred to herein as a backing layer) and an adhesive layer 13.
  • the convexity adjusting device 14 may be configured to provide a partial or sectionalized adjustment of the barrier convexity as the ostomy barrier appliance 10 is applied to a user and conforms to the user’s peristomal topography.
  • Characteristics that define a convexity of an ostomy barrier appliance can include depth, compressibility, flexibility, tension location, and slope. See, McNichol, L., Cobh, T, Depai f’e, Y, Quigley, M., Smitka, K., & Gray, M., Characteristics of Convex Skin Barriers and Clinical Application: Results of an International Consensus Panel, J Wound Ostomy Continence Nurs., (2021) 48(6), 524-532, Abstract.
  • the depth of a convex skin barrier can be defined as a distance from the apex of a dome to a base of the convex skin barrier. Id, at pg.
  • the depth can be measured as a magnitude of a convexity from a base lying on the peristomal skin to the highest point of a convex skin barrier as shown in FIG. 3.
  • Individual user’s peristomal condition such as depths of creases and folds around the stoma, should be carefully considered when selecting a depth of a convex skin barrier to provide an optimal seal around the peristomal skin. Id.
  • the compressibility of a convex skin barrier can be defined as a capacity of a dome portion to be displaced or flattened as illustrated in FIG. 4. Id, at pg. 528. The compressibility may be measured as a force required to displace or flatten the dome portion of a convex skin barrier by a predetermined distance.
  • a relatively easily compressible soft convex barrier may conform better to users with postoperative edema and/or a relatively firm abdominal. Id.
  • a relatively less compressible firm convex barrier may apply more pressure on the peristomal skin to provide support needed for users with a relatively soft abdominal tone and/or creases around the stoma. Id.
  • the flexibility of a convex skin barrier can be defined as how easily the convex skin barrier can bend, as illustrated in FIG. 5. Id, at pg. 529. The flexibility is an important characteristic to consider when a skin barrier needs to bend to conform to abdominal contours. Id. A relatively more flexible convex skin barrier may work well for users with multiple creases around stoma due to loose skin. Id.
  • the tension location of a convex skin barrier is defined as the position in which a convex dome exerts downward and outward forces on the peristomal topography, as illustrated in FIGS. 6A and 6B. Id, at pg. 530.
  • a convex skin barrier configured to apply a tension close to a stoma may provide a consistent and reliable seal around the stoma that is flush to the skin or retraced below the skin.
  • a convex barrier skin barrier configured to apply a tension away from the stoma may help flatten the peristomal skin to provide a good seal. Id.
  • the slope of a convex skin barrier is defined as an angle from a base of the dome to a periphery of the apex of the dome, as illustrated in FIG. 7. Id, at pg. 53. Creases and folds around the stoma can compromise a seal between a skin barrier and the skin. Adjusting the slope of a convex skin barrier according to user’s peristomal topography can improve the seal. For example, a convex skin barrier with a relatively small slope and wider plateau may help flatten the peristomal skin creases and folds to achieve a good seal. Id.
  • the ostomy barrier appliance 10 may be provided as a convex barrier having a positive convexity depth D, wherein a dome of the ostomy barrier appliance 10 (an inner portion proximate the inlet opening 16) protrudes toward a user when the ostomy barrier appliance 10 is placed adjacent the user.
  • the ostomy barrier appliance 10 may be configured to allow adjustment of the convexity depth D from a positive depth (FIG. 2A), wherein the dome protrudes toward a user, to a negative depth (FIG. 2B), wherein the dome is inverted and protrudes away from a user according to the peristomal topography of a user.
  • the ostomy barrier appliance 10 may be configured for sectional adjustment of the convexity depth D according to user’s peristomal topography.
  • the ostomy barrier appliance 10 may be initially provided as a convex barrier having a predetermined positive convexity depth D around the inlet opening 16 (FIG. 2A) and may be adjusted as the ostomy barrier appliance 10 is attached to a user to provide a different convexity depth D in at least a section around the inlet opening 16 according to the topography of user’s peristomal skin.
  • a user may have a protruding convex peristomal topography T1 in one area and a generally flat peristomal topography T2 in another area (FIG. 2C).
  • the ostomy barrier appliance 10 may be adjusted to provide a section having a negative convexity depth D corresponding to the protruding convex peristomal topography T1 and a section having a generally zero convexity depth D corresponding to the generally flat peristomal topography T2 as shown in FIG. 2C.
  • a user may have a protruding convex peristomal topography T1 in one area and a sunken depressed peristomal topography T3 in another area (FIG. 2D).
  • the ostomy barrier appliance 10 may be adjusted to provide a section having a negative convexity depth D corresponding to the protruding convex peristomal topography T1 and a section having a positive convexity depth D corresponding to the sunken depressed peristomal topography T3 as shown in FIG. 2D.
  • a user may have a complex peristomal topography including a first section having a protruding convex peristomal topography, a second section having a sunken depressed peristomal topography and a third section having a generally flat peristomal topography.
  • the ostomy barrier appliance 10 may be adjusted to provide a first section having a negative convexity depth D corresponding to the protruding convex peristomal topography, a second section having a positive convexity depth D corresponding to the sunken depressed peristomal topography, and a third section having a generally zero convexity depth D corresponding to the generally flat peristomal topography.
  • the convex adjusting device 14 may be configured to provide the sectional convexity adjustment feature of the ostomy barrier appliance 10 that allows adjustment of a convexity depth D from a positive depth to a negative depth and any depth therebetween according to user’s peristomal topography.
  • the convexity adjusting device 14 may include radially extending members 20 separated by gaps 22, which may be configured to separately adjust the convexity depth D of the ostomy barrier appliance 10.
  • the radially extending members 20 include ends 24 near inlet opening 16.
  • the convexity adjusting device 14 may be attached to a distal side of the skin barrier 18.
  • FIGS. 8-10 show the convexity adjusting device 14’ according to an embodiment.
  • FIG. 8 is a perspective body side view of the convexity adjusting device 14’
  • FIG. 9 is a perspective distal side view of the convexity adjusting device 14’
  • FIG. 10 is a schematic partial cross sectional view of the convexity adjusting device 14’.
  • the convexity adjusting device 14’ may be used in an ostomy barrier appliance, such as the convex ostomy barrier appliance 10.
  • the convexity adjusting device 14’ may include a base 22’, a dome 24’, and a middle portion 26’ connecting the base 22’ and the dome 24’.
  • the dome 24’ may be defined by a plurality of radially extending members 28’, wherein each of the plurality of radially extending members 28’ may be separated by a gap 30’.
  • Each of the radially extending members 28’ may include a peripheral end 32’ defining an inlet opening.
  • the dome 24’ and the middle portion 26’ may extend from the base 22’ and protrude toward a body side direction such that the base 22’ and the dome 24’ are arranged in different planes.
  • 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).
  • the convexity adjusting device 14’ may be configured to include 10 radially extending members 28’.
  • the depth D of the convexity adjusting device 14’ is measured from a body side surface of the base 22’ to the apex of the convexity adjusting device 14’ as shown in FIG. 10.
  • the convexity slope 0 is a maximum slope measured on a body side surface of the convex insert 14’. In the embodiment of FIG. 10, the convexity slope 0 is measured at a transition point 40’ between a concave body side surface 42’ and a convex body side surface 44’.
  • the convex adjusting device 14’ may be configured to have a convexity depth D, a convexity slope 0, flexibility, and compressibility characteristics to provide the sectional convexity adjustment feature of the ostomy barrier appliance 10.
  • the compressibility of an ostomy barrier appliance 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 15 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.
  • 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.
  • the openings 142 may be sized to receive a coupling flange of differently sized ostomy barrier appliances.
  • 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.
  • 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.
  • 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.
  • FIG. 18 is a side view of an ostomy barrier appliance 10 arranged on the tensile testing machine 110 during the compressibility test.
  • 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.
  • 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.
  • 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.
  • 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.
  • the compressibility test may be performed on ostomy barrier appliances of different sizes.
  • 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.
  • 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.
  • 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.
  • FIGS. 19-30 are directed to a test method for testing flexibility of an ostomy barrier appliance, for example, the convex ostomy barrier appliance 10 or the convex insert 14, which is described and referred herein as the flexibility test method.
  • FIG. 19 shows a portion of a tensile testing machine 210 for performing the flexibility test method according to an embodiment.
  • the tensile testing machine 210 may include an upper platen 212 and a lower platen 214.
  • An upper platen insert 216 may be attached to the upper platen 212.
  • the lower platen insert 218 may be attached to the lower plate 218.
  • the upper platen 212 may be moved toward the lower platen 214, or vice versa to perform the flexibility test method.
  • the tensile testing machine 210 may include test works software or equivalent, or be operably coupled to a computing device having test works software or equivalent.
  • the tensile testing machine 210 may provide a constant rate of traverse when one platen moves toward the other.
  • 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.
  • FIGS. 21 and 22 show examples of ostomy barrier appliances 10 being prepared for the flexibility test.
  • the outer flange 16 may be trimmed as indicated by the cut lines 220.
  • an injection-molded portion such as the coupling flange 22 or convexity adjusting device 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.
  • 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.
  • 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.
  • the first length may be longer than a second length.
  • 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
  • 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.
  • FIGS. 25-27 show examples of the ostomy barrier appliance 10 being positioned in the tensile testing machine 210 for the flexibility test.
  • the trimmed, horizontal edges 222 may be arranged in respective positioning slots 224 of the upper and lower platen inserts 216, 218.
  • 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.
  • the ostomy barrier appliance 10 may be substantially centered in a lateral direction of the upper and lower and platen inserts. Referring to FIGS.
  • 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. [0090] FIG.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • FIG. 30 shows an example of the ostomy barrier appliance 10 exhibiting an unintended bending pattern during the flexibility test.
  • 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.
  • 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.
  • 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.
  • 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.
  • an initial speed i.e., a speed of the platen providing the compressive force
  • the strain end point may be approximately 0.5 in/in
  • the data acquisition rate may be approximately 10.0 Hz.
  • 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.
  • 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.
  • N pre-bend force at -2% strain
  • N*mm energy at -30% strain
  • N*mm definite integral from 0 mm extension to 30% of
  • 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.
  • 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.
  • each convexity adjusting device 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.
  • the area under the force measurement curve was calculated to obtain energy at -30% strain of the convexity adjusting device sample.
  • the convexity adjusting device 14, 14’ may be provided as a convex device having a positive convexity depth D and configured to have an adjustable depth D range from about 14 mm to about -14 mm, preferably from about 8 mm to about -8 mm, more preferably from about 6 mm to about -6 mm, and an adjustable convexity slope 0 range from about 80° to about -80°, preferably about 65° to about -65°, more preferably about 50° to about -50°.
  • the convexity adjusting device 14, 14’ may be configured to have a flexibility measured in energy expended to deform the convexity adjusting device by 30% according to the flexibility test method of about 0 N*mm to about 50 N*mm, preferably about 10 N*mm to about 40 N*mm, more preferably about 20 N*mm to about 30 N*mm, and compressibility measured in energy expended to compress 3 mm of the convex portion 15 of the soft convex inert according to the compressibility test method of about 0 N*mm to about 25 N*mm, preferably about 3 N*mm to about 15 N*mm, more preferably about 5 N*mm to about 10 N*mm.
  • the convexity adjusting device 14, 14’ may be configured to have a ratio of dome thickness 46’ to hoop thickness 48’ (FIG. 10) of about 0.25: 1.0 to about 0.8: 1.0, preferably about 0.58: 1.0 to about 0.7: 1.0, and more preferably of about 0.6: 1.0.
  • the dome thickness is a minimum cross sectional thickness of the convexity adjusting device 14, 14’ in the convex body side portion 44’
  • the hoop thickness is a maximum cross sectional thickness of the convexity adjusting device 14, 14’ in the concave body side portion 42’.
  • the convexity adjusting device 14, 14’ may be provided as a convex device having a positive convexity depth D of about 6.5 mm to 7 mm, a convexity slope 0 of about 50°, flexibility measured in energy expended to deform the convexity adjusting device by 30% according to the flexibility test method of about 25 N*mm, compressibility measured in energy expended to compress 3 mm of the convex portion 15 according to the compressibility test method of about 7 N*mm, and a ratio of dome thickness 46’ to hoop thickness 48’ of about 0.6: 1 .0.
  • FIGS. 31-33 show a convexity adjusting device 314 according to an embodiment.
  • FIG. 31 is a perspective body side view of the convexity adjusting device 314,
  • FIG. 32 is a perspective distal side view of the convexity adjusting device 314, and
  • FIG. 33 is a partial cross-sectional view of the convexity adjusting device 314.
  • the convexity adjusting device 314 may be configured to have the similar convexity characteristics (e.g., depth, slope, compressibility, flexibility, and dome thickness to hoop thickness ratio) of the convexity adjusting device 14, 14’ and may include a convex member 318, which has a similar cross sectional configuration as that of the convexity adjusting device 14, 14’, and a plurality of beam members 320.
  • the convexity adjusting device 314 may be configured such that each of the plurality of beam members 320 may be flexed independently.
  • the convexity adjusting device 314 may be initially configured with each of the plurality of beam members 320 extended away as shown in FIG. 33.
  • each of the plurality of beam members 320 may be independently pressed to flex as the ostomy barrier appliance is pressed against the peristomal skin to adjust the convexity according to the topography of the peristomal skin.
  • the convexity adjusting device 314 may be configured for adjustment of a convexity depth D from a positive depth to a negative depth to conform to user’s peristomal topography similar to the convexity adjusting device 14, 14’.
  • Each of the plurality of beam members 320 may include a hinged zone 328 configured to facilitate flexing of the beam member 320 as the ostomy barrier appliance is applied to a user.
  • the hinged zone 328 may be formed on body side and distal side of each of the beam members 320 as best shown in FIG. 33. In other embodiments, the hinged zone 328 may be formed only on the distal side of each of the beam members 320 or formed only on the body sides of the beam members 320.
  • each of the beam members 320 includes a convex dome portion 332 configured to generally match a convex body side contour of adjacent dome 324 areas of the convex member 318.
  • the convexity adjusting device 14, 14’, 314 may be formed from a suitable material, such as polymeric materials, rubber, silicone, or metallic materials.
  • the convexity adjusting device 14, 14’, 314 may be formed from a heat sealable thermoplastic material, such as ethylene vinyl acetate (EVA) copolymer, thermoplastic elastomer, or thermoplastic urethane.
  • EVA ethylene vinyl acetate
  • convexity adjusting device 14, 14’, 314 may be formed from EVA copolymer having a modulus of about 7400 psi and durometer of about 90A, such as ELVAXTM-450 available from Dow.
  • FIGS. 34A-D show schematic cross-sectional views of an ostomy barrier appliance 400 conforming to various peristomal topographies according an embodiment.
  • the ostomy barrier appliance 400 may be configured similar to the ostomy barrier appliance 10 generally comprising a skin barrier 418 and a convexity adjusting device 414.
  • the convexity adjusting device 414 may be configured similarly to the convexity adjusting device 14, 14’.
  • the convexity adjusting device 414 may be configured to have a pivot point 421 proximate the base 422, such that a dome 424 and a middle portion 426 may pivot at pivot point 421 as the convexity adjusting device 414 conforms to various peristomal topographies as shown in FIGS. 34A-34D.
  • FIG. 34A shows the ostomy barrier appliance 400 in an initial state and arranged adjacent user’s peristomal skin 401.
  • the ostomy barrier appliance 400 may be configured as a convex ostomy barrier having a positive convexity depth DI that protrudes toward user’s peristomal skin 401 in the initial state as shown in FIG. 34A.
  • pressure P may be applied to the dome 424 and/or middle portions 426.
  • FIG. 34B shows the ostomy barrier appliance 400 being conformed to a sunken concave peristomal topography 401, wherein the dome 424 and middle portion 424 have been pressed down to provide a positive convexity depth D2 that is less than the positive convexity depth D2.
  • FIG. 34C shows the ostomy barrier appliance 400 being conformed to a generally flat peristomal topography 401’, wherein the dome 424 and middle portion 426 have been inverted to provide a negative convexity depth D3.
  • 34 D shows the ostomy barrier 400 being conformed to a protruding peristomal topography 401”, wherein the dome 424 and middle portion 426 have been inverted to a maximum compression inversion state providing a negative convexity depth D4 greater than the negative convexity depth D3.
  • the convexity adjusting device 414 may be configured such that the dome 424 and middle portion 426 may provide a funnel or a cone-like protection around the stoma 402 when inverted.
  • the inverted dome 424 and middle portion 426 may facilitate flow of stoma effluent into an ostomy pouch and deter stoma effluent away from the peristomal skin.

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Abstract

L'invention concerne un appareil de barrière de stomie pour fixer un appareil de poche de stomie à une peau péristomiale entourant une stomie, comprenant une barrière cutanée et un dispositif de réglage de convexité fixé à un côté distal de la barrière cutanée pour définir la convexité de l'appareil de barrière de stomie convexe. Le dispositif de réglage de convexité est conçu pour un réglage de profondeur de convexité de la barrière cutanée d'une première profondeur de convexité positive à une seconde profondeur de convexité lorsque l'appareil de barrière de stomie se conforme à la topographie péristomale d'un utilisateur lorsqu'il est appliqué à l'utilisateur, la seconde profondeur de convexité pouvant être une profondeur de convexité positive inférieure à la première profondeur de convexité positive, nulle ou une profondeur de convexité négative.
PCT/US2024/054933 2023-11-08 2024-11-07 Appareil de barrière de stomie ayant une convexité réglable douce Pending WO2025101759A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100114044A1 (en) * 2007-04-09 2010-05-06 Cramer Kathryn E Adhesive body fitment for ostomy appliane
US20190117441A1 (en) * 2013-01-29 2019-04-25 Coloplast A/S Ostomy appliance having a lubricating edge
US20200337884A1 (en) * 2019-04-25 2020-10-29 Convatec Technologies Inc. Ostomy wafers incorporating adhesives, ostomy devices including the same, and methods of applying ostomy wafers and ostomy devices
CA3233778A1 (fr) * 2021-10-11 2023-04-20 James P. WINES Gabarit de stomie et procede de fabrication d'une barriere cutanee pour stomie personnalisee
WO2023212537A1 (fr) * 2022-04-25 2023-11-02 Hollister Incorporated Appareil de barrière de stomie à convexité ajustable auto-activante

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100114044A1 (en) * 2007-04-09 2010-05-06 Cramer Kathryn E Adhesive body fitment for ostomy appliane
US20190117441A1 (en) * 2013-01-29 2019-04-25 Coloplast A/S Ostomy appliance having a lubricating edge
US20200337884A1 (en) * 2019-04-25 2020-10-29 Convatec Technologies Inc. Ostomy wafers incorporating adhesives, ostomy devices including the same, and methods of applying ostomy wafers and ostomy devices
CA3233778A1 (fr) * 2021-10-11 2023-04-20 James P. WINES Gabarit de stomie et procede de fabrication d'une barriere cutanee pour stomie personnalisee
WO2023212537A1 (fr) * 2022-04-25 2023-11-02 Hollister Incorporated Appareil de barrière de stomie à convexité ajustable auto-activante

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Title
MCNICHOL, LCOBB, TDEPAIFVE, 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., vol. 48, no. 6, 2021, pages 524 - 532

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