WO2016061434A1 - Brides de stomie à base de stratifié élastomère à mousse thermoplastique pour une soudure facile à une poche de stomie - Google Patents

Brides de stomie à base de stratifié élastomère à mousse thermoplastique pour une soudure facile à une poche de stomie Download PDF

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Publication number
WO2016061434A1
WO2016061434A1 PCT/US2015/055893 US2015055893W WO2016061434A1 WO 2016061434 A1 WO2016061434 A1 WO 2016061434A1 US 2015055893 W US2015055893 W US 2015055893W WO 2016061434 A1 WO2016061434 A1 WO 2016061434A1
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WO
WIPO (PCT)
Prior art keywords
foam
ostomy
thermoplastic elastomer
layer
flange
Prior art date
Application number
PCT/US2015/055893
Other languages
English (en)
Inventor
Michael PLANCKAERT
Original Assignee
Avery Dennison Corporation
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Avery Dennison Corporation filed Critical Avery Dennison Corporation
Publication of WO2016061434A1 publication Critical patent/WO2016061434A1/fr

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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; Portable urination aids; 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; Portable urination aids; Colostomy devices
    • A61F5/443—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having adhesive seals for securing to the body, e.g. of hydrocolloid type, 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; Portable urination aids; Colostomy devices
    • A61F5/445—Colostomy, ileostomy or urethrostomy devices
    • A61F5/448—Means for attaching bag to seal ring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L28/00—Materials for colostomy devices
    • A61L28/0007—Materials for colostomy devices containing macromolecular materials
    • A61L28/0011—Materials for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L28/00—Materials for colostomy devices
    • A61L28/0034—Use of materials characterised by their function or physical properties
    • A61L28/0053—Porous materials, e.g. foams or sponges

Definitions

  • the present subject matter relates to ostomy flanges, ostomy appliances, and related methods of making and using the same.
  • Ostomy appliances are designed for collecting waste, discharge, or exudate from a stoma resulting from a surgically diverted biological system, such as a colon, ileum, bladder, etc. Stoma sites can result from certain medical procedures such as colostomy, urostomy, tracheostomy, and gastrostomy procedures.
  • Ostomy pouching systems/appliances allow discharge from the stoma of an ostomy patient to drain into a sealed collection pouch, while protecting the surrounding skin from contamination from the discharge.
  • One-piece ostomy systems typically include a flange and a pouch joined together as a single unit.
  • the one-piece ostomy appliance includes an adhesive on the flange for bonding the flange to peristomal skin surrounding a stoma of an ostomy patient.
  • Typical ostomy flanges comprise a foam substrate and typical pouches include a flexible bag comprising a polymer film construction.
  • the flange and pouch are typically produced at different times and separately from one another, and often by different manufacturers.
  • One manufacturer may produce the ostomy pouch and a second manufacturer may produce the foam flange having an appropriate skin contacting adhesive on one side.
  • a third manufacturer joins the flange and pouch together to complete the assembly of an ostomy appliance.
  • the third manufacturer may use an adhesive to bond the foam substrate to the pouch.
  • the flanges including the adhesive may be stacked one upon another, resulting in the flanges sticking together.
  • the application of such adhesive to the flange requires significant precautions be taken so that the adhesive on the flange is not contaminated for example, by coming into contact with dirt, moisture, or a different surface or substrate than the intended pouch.
  • These precautions must be employed after the adhesive is applied to the flange and before the flange is bonded to the pouch, i.e. when the adhesive is exposed on the surface of the flange.
  • Such precautions may require economically costly activities, time, and resources devoted to protecting the adhesive from such contamination, and may thereby add to the cost of producing such ostomy appliances.
  • the present subject matter relates to foam-thermoplastic elastomer laminate based ostomy flanges designed for easy welding to ostomy pouches, and related methods of forming an ostomy flange.
  • foam-thermoplastic elastomer laminate based ostomy flanges designed for easy welding to ostomy pouches, and related methods of forming an ostomy flange.
  • Such flanges can be easily attached to a pouch and have sufficient seal strength with the pouch.
  • the flanges and related methods do not require additional and costly precautions to be taken to prevent contamination of an adhesive that is typically applied to the ostomy flange for bonding to an ostomy pouch.
  • the ostomy flanges made in accordance with the present subject matter can be handled without fear of contaminating an adhesive on the ostomy flange, and thus do not require economically costly activities, time, and resources devoted to protecting against such contamination.
  • the present subject matter provides an ostomy flange comprising a foam substrate including a first face and a second face, a thermoplastic elastomer layer, a hydrocolloid adhesive layer, and a tie layer.
  • the thermoplastic elastomer layer is bonded with the first face of the foam substrate.
  • the tie layer bonds the hydrocolloid adhesive layer with the second face of the foam substrate.
  • the present subject matter provides an ostomy flange comprising a first foam substrate including a first face and a second face, a second foam substrate including a first face and a second face, a hydrocolloid adhesive layer, and a tie layer.
  • the second foam substrate contains at least one thermoplastic elastomer.
  • the second foam substrate containing the thermoplastic elastomer is bonded with the first face of the first foam substrate.
  • the tie layer bonds the hydrocolloid adhesive layer with the second face of the first foam substrate.
  • the present subject matter provides an ostomy appliance comprising a pouch, a foam wafer, and an adhesive layer.
  • the pouch defines an interior and includes an opening providing access to the interior.
  • the foam wafer is bonded with the pouch and includes a first surface and a second surface.
  • the adhesive layer covers the second surface of the foam wafer.
  • a thermoplastic elastomer forms a weld between the first surface of the foam wafer and an outer surface of the pouch and the weld surrounds the opening.
  • the present subject matter provides an ostomy appliance comprising a pouch, a foam wafer, and an adhesive layer.
  • the pouch defines an interior and includes an opening providing access to the interior.
  • the foam wafer is bonded with the pouch and includes a first foam layer with a first and second surface and a second foam layer with a first and second surface.
  • the adhesive layer covers the second surface of the first foam layer of the foam wafer.
  • the second foam layer of the foam wafer contains a thermoplastic elastomer.
  • the second foam layer with the thermoplastic elastomer forms a weld between the surface of the foam wafer and an outer surface of the pouch and the weld surrounds the opening.
  • a method of making an ostomy flange includes providing a foam washer defining a first face and a second face.
  • a thermoplastic elastomer film is laminated to the first face of the foam washer.
  • a hydrocolloid adhesive layer is laminated to the second face of the foam washer using a tie material situated between the second face of the foam washer and the hydrocolloid adhesive layer.
  • a method of making an ostomy flange includes providing a foam washer that includes a first foam layer with a first and second surface and a second foam layer with a first and second surface.
  • the second foam layer contains a thermoplastic elastomer.
  • the second foam layer is laminated to the first face of the first foam layer of the foam washer.
  • a hydrocolloid adhesive layer is laminated to the second face of the first foam layer of the foam washer using a tie material situated between the second face of the foam washer and the hydrocolloid adhesive layer.
  • a method of making an ostomy appliance is provided. The method includes providing a pouch defining an interior and including an opening providing access to the interior.
  • a foam wafer which defines a first surface and a second surface and includes an adhesive layer covering the second surface.
  • the first surface of the foam wafer is welded with an outer surface of the pouch.
  • Welding includes i) positioning a thermoplastic elastomer between the foam wafer and the outer surface of the pouch, and ii) pressing together the foam wafer and the pouch while heating the thermoplastic elastomer. A resulting weld surrounds the opening in the pouch.
  • a method of making an ostomy appliance includes providing a pouch defining an interior and including an opening providing access to the interior.
  • a foam wafer is provided, including a first foam layer which defines a first surface and a second surface and a second foam layer, the foam wafer includes an adhesive layer covering the second surface of the first foam layer.
  • the second foam layer contains a thermoplastic elastomer. The second foam layer of the foam wafer is welded with an outer surface of the pouch.
  • Welding includes i) positioning a second foam layer containing the thermoplastic elastomer between the first foam layer of the foam wafer and the outer surface of the pouch, and ii) pressing together the foam wafer and the pouch while heating the thermoplastic elastomer containing second foam layer. A resulting weld surrounds the opening in the pouch.
  • Figure 1 is a schematic, perspective view of an ostomy flange in accordance with the present subject matter.
  • Figure 2 is a schematic, cross-sectional perspective view of the ostomy flange depicted in Figure 1 with an optional release liner, in accordance with the present subject matter.
  • Figure 3 is a schematic, plan view of an ostomy appliance in accordance with the present subject matter.
  • Figure 4 is a schematic, cross-sectional view of the ostomy appliance of FIG. 3 taken along line 4-4 from FIG. 3.
  • Figure 5 is a schematic, detailed cross-sectional view of the ostomy appliance of FIG. 4 taken from the portion indicated by hashed circle 5 in FIG. 4, and applied to peristomal skin of an ostomy patient.
  • Figure 6 is a schematic, perspective view of another ostomy flange in accordance with the present subject matter.
  • Figure 7 is a schematic, cross-sectional perspective view of the ostomy flange depicted in Figure 6 with an optional release liner, in accordance with the present subject matter.
  • Figure 8 is another schematic, cross-sectional view of the ostomy appliance of FIG. 3 taken along line 4-4 from FIG. 3.
  • Figure 9 is a schematic, detailed cross-sectional view of the ostomy appliance of FIG. 8 taken from the portion indicated by hashed circle 5 in FIG. 8, and applied to peristomal skin of an ostomy patient.
  • Ostomy flanges can typically include a polyethylene foam substrate.
  • Polyethylene foam is not easily welded onto ostomy pouches because in order to do so, high temperatures and pressures are required that risk damage to the pouches and flanges which may result in leakage of the contents of the pouches.
  • ostomy appliance manufacturers typically apply a ring of adhesive onto the foam substrate of the ostomy flange, which is used at a later time to bond the foam substrate to the ostomy pouch. The flanges are stacked before a final operation of bonding the flange to the pouch.
  • the stacked flanges are then removed from the stack and individually bonded to an ostomy pouch in a bonding step.
  • the application of the adhesive is performed prior to the final bonding step and therefore, the adhesive remains exposed on a surface of the foam substrate for a period of time.
  • the exposed adhesive may cause two or more flanges to stick together. Sticking of stacked flanges may lead to efficiency losses in the manufacturing process of the ostomy appliance, and may require costly precautions to be taken by the manufacturer in order to prevent flanges from sticking together or other adhesive contamination. Such precautions may include drying or curing the adhesive, applying a release liner over the exposed adhesive, or the like.
  • the ostomy flanges of the present subject matter address these problems and incorporate a thermoplastic elastomer layer on a foam substrate.
  • the thermoplastic elastomer layer is used to bond the flange to the ostomy pouch.
  • the thermoplastic elastomer layer is applied and cooled on the foam substrate during manufacturing of the ostomy flange itself - at a time before final bonding of the foam substrate to the ostomy pouch.
  • the thermoplastic elastomer layer is not tacky during subsequent handling or processing steps that may be performed by a final ostomy appliance manufacturer. Accordingly, the final ostomy appliance manufacturer does not need to take precautions to prevent contamination of an adhesive layer that may otherwise be needed to bond the flange to an ostomy pouch.
  • the ostomy flanges of the present application address the problem by including a second foam layer that includes a thermoplastic elastomer.
  • the second foam layer that includes the thermoplastic elastomer is used to bond the flange to the ostomy pouch.
  • the final ostomy appliance manufacturer needs to only heat and/or press the thermoplastic elastomer layer or thermoplastic elastomer containing foam between the flange and pouch, and then cool the thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer to create a weld between the flange and pouch.
  • the heating required to form the weld does not damage, such as by heat degradation, either the pouch or the foam substrate, yet provides an adequate bond so that the flange does not separate from the pouch during normal use by an ostomy patient.
  • Such bonding operations can be accomplished by a final ostomy appliance manufacturer using conventional thermoplastic converting equipment.
  • the welding of the flange to the ostomy pouch may provide a one-piece ostomy appliance used to collect discharge from a stoma in an ostomy patient.
  • the resulting combination of the flange and pouch can be used in a two-piece ostomy appliance.
  • the foam substrate includes an adhesive on a side of the foam substrate opposite from the thermoplastic elastomer layer.
  • the first foam layer of the foam substrate includes an adhesive on the side opposite the second foam layer containing the thermoplastic elastomer.
  • the adhesive layer may be used to adhere the ostomy appliance to peristomal skin of an ostomy patient.
  • the adhesive layer on the foam substrate may include a hydrocolloid adhesive which can be anchored to the foam substrate with a tie layer.
  • a release liner may be used to cover an exposed surface of the adhesive layer.
  • the ostomy flange is both flexible and yielding to conform to the contours of peristomal skin, and at the same time includes the thermoplastic elastomer that adequately bonds the foam substrate to the ostomy pouch. As such, the flange will not pull away from the ostomy pouch during normal use. Further, the ostomy flange includes the adhesive layer that adequately bonds the flange to peristomal skin such that a seal is created around the stoma that prevents the peristomal skin from being contaminated with discharge from the stoma.
  • the ostomy flange 10 includes an adhesive layer 20, a tie layer 30, a foam layer/substrate 40, and a thermoplastic elastomer layer 50.
  • the ostomy flange includes a skin contacting side 11 defined by the adhesive layer 20, and an ostomy pouch contacting side 12 defined by the thermoplastic elastomer layer 50.
  • the flange includes hole 13 extending from the skin contacting side 11 to the ostomy pouch contacting side 12.
  • hole 13 may not be included in the flange 10, wherein the ostomy flange may present a substantially continuous layered construction. In this instance, an ostomy patient may form hole 13 just prior to application to peristomal skin.
  • the ostomy flange 10 can also include a release liner 60 covering an exposed portion of the adhesive layer 20, e.g. covering the skin contacting side 11 of the flange 10. As will be understood, such release liner 60 can be removed from the adhesive layer 20 prior to application of the ostomy flange 10 to peristomal skin of an ostomy patient.
  • the foam layer 40 includes a first surface/face 41 and a second surface/face 42.
  • the thermoplastic elastomer layer 50 covers the first surface 41 of the foam layer 40 and the tie layer 30 covers the second surface 42 of the foam substrate 40.
  • the ostomy flange may include the foam substrate 40 and the thermoplastic elastomer layer 50 without necessarily including the adhesive layer 10, the tie layer 20, or the release liner 60; wherein all, some, or none of these layers are incorporated in the ostomy flange at a later production step.
  • the ostomy flange is welded to an ostomy pouch as illustrated in FIGS. 3 and 4.
  • an ostomy appliance 100 is designed for collecting discharge from a stoma, and includes an ostomy pouch 110 having an ostomy flange 10 welded/bonded thereto.
  • the pouch 110 defines an interior 111 and includes an opening 112 providing access to the interior.
  • the pouch 110 may include a drain 113 (illustrate by a hashed line) for removing stoma discharge from the interior 111 of the pouch 110.
  • the flange 10 is shown in FIG. 4 to cover the opening 112 of the pouch 110, wherein hole 13 in the flange 10 aligns with the opening 112.
  • the ostomy appliance 100 includes a release liner 60 and is shown in FIG. 4 covering the skin contacting side 11 of the flange, i.e. covering the adhesive layer 20. It will be understood that the release liner 60 can be removed from the adhesive layer 20 before application of the appliance 100 to peristomal skin of an ostomy patient.
  • the release liner 60 covering the adhesive layer may include a finger tab 62 as shown in FIG. 3. The tab 62 may be present so that an ostomy patient may easily remove the release liner 60 by pulling the tab 62 by hand.
  • the ostomy appliance can be applied to peristomal skin surrounding a stoma. This is shown for example in FIG. 5, wherein an ostomy appliance 100, including a flange 10 and pouch 110, is adhered to the peristomal skin 310 surrounding a stoma 200.
  • FIG. 5 is a close up illustration showing the section of the flange 10 indicated by the hashed circle 5 in FIG. 4, wherein the release liner has been removed and the ostomy appliance is applied to the peristomal skin 310.
  • the stoma 200 is shown in FIG. 5 to protrude outward from tissue 300 of an ostomy patient.
  • the stoma may be flush or recessed with the peristomal skin of an ostomy patient, as is common.
  • the ostomy flange may be convex and somewhat rigid so that the flange can be pressed firmly into the tissue 300 in order to properly seal to the peristomal skin 310 around the stoma 200.
  • the hole 13 in the ostomy flange 10 is aligned both with the stoma 200 and with the opening 112 in the pouch 110.
  • discharge from the stoma 200 can pass through hole 13 and through opening 112, such that the discharge from the stoma can be collected in the interior 111 of the pouch 110.
  • the foam substrate 40 is shown to include a first surface 41 and a second surface 42, wherein the thermoplastic elastomer layer 50 is applied to the first surface 41 and the tie layer 30 is applied to the second surface 42.
  • the ostomy flange 10 includes an adhesive layer 20, a tie layer 30, a first foam layer/substrate 40, and a thermoplastic elastomer containing second foam layer 55.
  • the ostomy flange includes a skin contacting side 11 defined by the adhesive layer 20, and an ostomy pouch contacting side 12 defined by the thermoplastic elastomer containing second foam layer 55.
  • the flange includes hole 13 extending from the skin contacting side 11 to the ostomy pouch contacting side 12.
  • hole 13 may not be included in the flange 10, wherein the ostomy flange may present a substantially continuous layered construction. In this instance, an ostomy patient may form hole 13 just prior to application to peristomal skin.
  • the ostomy flange 10 can also include a release liner 60 covering an exposed portion of the adhesive layer 20, e.g. covering the skin contacting side 11 of the flange 10. As will be understood, such release liner 60 can be removed from the adhesive layer 20 prior to application of the ostomy flange 10 to peristomal skin of an ostomy patient.
  • the first foam layer 40 includes a first surface/face 41 and a second surface/face 42.
  • the thermoplastic elastomer containing second foam layer 55 covers the first surface 41 of the foam layer 40 and the tie layer 30 covers the second surface 42 of the foam substrate 40.
  • the ostomy flange may include the foam substrate 40 and the thermoplastic elastomer containing second foam layer 55 without necessarily including the adhesive layer 10, the tie layer 20, or the release liner 60; wherein all, some, or none of these layers are incorporated in the ostomy flange at a later production step.
  • the ostomy flange is welded to an ostomy pouch as illustrated in FIGS. 3 and 8.
  • an ostomy appliance 100 is designed for collecting discharge from a stoma, and includes an ostomy pouch 110 having an ostomy flange 10 welded/bonded thereto.
  • the pouch 110 defines an interior 111 and includes an opening 112 providing access to the interior.
  • the flange 10 is shown in FIG. 8 to cover the opening 112 of the pouch 110, wherein hole 13 in the flange 10 aligns with the opening 112.
  • the ostomy appliance 100 includes a release liner 60 and is shown in FIG. 8 covering the skin contacting side 11 of the flange, i.e. covering the adhesive layer 20. It will be understood that the release liner 60 can be removed from the adhesive layer 20 before application of the appliance 100 to peristomal skin of an ostomy patient.
  • the release liner 60 covering the adhesive layer may include a finger tab 62 as shown in FIG. 3. The tab 62 may be present so that an ostomy patient may easily remove the release liner 60 by pulling the tab 62 by hand.
  • the ostomy appliance can be applied to peristomal skin surrounding a stoma. This is shown for example in FIG. 9, wherein an ostomy appliance 100, including a flange 10 and pouch 110, is adhered to the peristomal skin 310 surrounding a stoma 200.
  • FIG. 9 is a close up illustration showing the section of the flange 10 indicated by the hashed circle 5 in FIG. 8, wherein the release liner has been removed and the ostomy appliance is applied to the peristomal skin 310.
  • the stoma 200 is shown in FIG. 9 to protrude outward from tissue 300 of an ostomy patient.
  • the stoma may be flush or recessed with the peristomal skin of an ostomy patient, as is common.
  • the ostomy flange may be convex and somewhat rigid so that the flange can be pressed firmly into the tissue 300 in order to properly seal to the peristomal skin 310 around the stoma 200.
  • the hole 13 in the ostomy flange 10 is aligned both with the stoma 200 and with the opening 112 in the pouch 110.
  • discharge from the stoma 200 can pass through hole 13 and through opening 112, such that the discharge from the stoma can be collected in the interior 111 of the pouch 110.
  • the foam substrate 40 is shown to include a first surface 41 and a second surface 42, wherein the thermoplastic elastomer containing second foam layer 55 is applied to the first surface 41 and the tie layer 30 is applied to the second surface 42.
  • the ostomy flange includes a foam substrate.
  • the foam substrate is provided to at least partially fill the space between peristomal skin of an ostomy patient and an ostomy pouch.
  • the foam substrate also provides a base to which the thermoplastic elastomer layer and the adhesive layer and tie layer are applied.
  • the foam substrate seals the ostomy pouch with the peristomal skin of an ostomy patient.
  • the foam substrate can be two different layers. The second layer containing the thermoplastic elastomer. In this embodiment there is no separate thermoplastic elastomer layer.
  • the foam substrate used in the flange is not particularly limited by the present subject matter and in one embodiment the foam substrate is to some degree yielding, compliant, and flexible.
  • the foam substrate can be one layer or two separate layers.
  • the ostomy flange is able to fill the space between two or more joined objects, e.g. between the ostomy pouch and peristomal skin of an ostomy patient, that do not necessarily have flat and smooth surfaces.
  • the foam substrate allows less-than-perfect mating surfaces, i.e. mating surface that are not totally flat or smooth, to be sealed together, wherein the ostomy flange can fill irregularities in the mating surfaces between the ostomy pouch and the peristomal skin.
  • the foam layer is compliant, yielding, and flexible such that irregularities in the peristomal skin of an ostomy patient may be accommodated by the compliant foam substrate.
  • any folds, creases, or contours of the peristomal skin can be accommodated by using the flexible foam substrate.
  • the flexible foam substrate thereby generally allows the ostomy flange to prevent leakage from or into the joined objects.
  • the foam substrate is somewhat rigid or is made somewhat rigid by incorporating a rigid layer or construction as part of the ostomy appliance.
  • a shape of the foam substrate is substantially retained during use of the flange in collecting waste from a stoma.
  • the ostomy appliance can additionally include a rigid material to impart a particular shape, for example convex, to the ostomy flange.
  • the shape of the foam substrate is not particularly limited by the present subject matter, and may be in the form of a gasket, wafer, washer, disk, plate, or shape as desired for a particular application. Accordingly, the terms foam substrate, foam gasket, foam wafer, foam washer, foam disk, foam plate, and the like are used interchangeably herein to refer to the foam layer 40 of the ostomy flange 10. As shown in the figures, the foam substrate comprises a generally flat, smooth, and round layer. However, the foam substrate is not limited to such shapes and configurations and can include other shapes and configurations as desired for a particular application, including square, hexagon, or other shapes having a contoured or curved shape and a surface that is not smooth.
  • the foam substrate is shown in FIGS. 1, 2, 4, 5, and 6-9 to include, or to partially define, the hole 13 in the ostomy flange 10.
  • the hole formed in the ostomy flange may not initially be present in the foam substrate 40, but may be formed in a post-production step wherein an ostomy patient or a health care worker may form the hole 13 in the ostomy flange just prior to application to peristomal skin of the ostomy patient.
  • the foam layer 40, and other layers of the ostomy flange may be substantially continuous layers being free of voids or apertures which may otherwise define hole 13 in the flange 10.
  • the first surface 41 of the foam substrate 10 is on a side of the foam substrate opposite from the second surface 42. That is, the first surface 41 and the second surface 42 are oppositely directed.
  • a thermoplastic elastomer layer 50 or thermoplastic elastomer containing second foam layer 55 covers the first surface 41 of the foam substrate 40.
  • the thermoplastic elastomer layer 50 or thermoplastic elastomer containing second foam layer 55 directly abuts the first surface 41 of the foam substrate 40.
  • the adhesive layer 20 covers the second surface 42 of the foam substrate 40.
  • the adhesive layer 20 may be anchored to the second surface 42 of the foam substrate 40 with a tie layer 30 as shown in the drawings.
  • the composition, density, and thickness of the foam substrate are not particularly limited by the present subject matter.
  • the foam layer may comprise an open- or closed-cell foam made from one or more polymers including but not limited to polyurethane, polyisocyanurate, polyvinyl chloride, polyimides, silicone, phenolic resins, polystyrene, polyolefins, acrylates, or combinations thereof.
  • the foam substrate comprises polyethylene foam.
  • the density of the foam substrate can range anywhere from about 25 - 330 kg/m 3 , or from about 80 - 120 kg/m 3 .
  • the thickness of the foam substrate can range anywhere from 0.2 mm to about 8 mm, or from about 0.5 mm to about 3.0 mm or more.
  • the foam substrate (or first foam substrate) can be from .7-.9 mm thick.
  • the foam substrate comprises compliant polyethylene foam having a density of about 100 kg/m 3 and a thickness of about 1.0 mm.
  • a suitable foam substrate can include polyolefin foam of grade TA S Z, TL SRZ, or TEE SRZ, provided by Sekisui Alveo AG, of Luzern, Switzerland. In one embodiment the foam substrate is .8 mm.
  • thermoplastic elastomer such as, but not limited to, ethylene vinyl acetate, ethyl methacrylate, polycaprolactone, polycarbonates, fluoropolymers, polypyrrole, ethylene acrylate, styrenic block copolymers (TPE-s), thermoplastic elastomer polyolefin blends (TPE-o), elastomeric polyolefin alloys (TPE-v or TPV), thermoplastic polyurethanes (TPU), thermoplastic vulcanizates, thermoplastic copolyester, thermoplastic polyamides, metallocene- catalyzed polyolefin plastomers & elastomers
  • TPE thermoplastic elastomer
  • TPU thermoplastic elastomer
  • the foam layer containing the thermoplastic elastomer can be a polyethylene foam with ethyl methacrylate as the thermoplastic elastomer.
  • the thickness of this thermoplastic containing foam layer can be from .1 mm to about 8 mm, from about .1 mm to .5 mm or from about .1 mm to .3 mm. In one instance the foam layer containing the thermoplastic elastomer is .2 mm.
  • the foam layer containing the thermoplastic elastomer is included to provide an adequate bond between the foam wafer and the ostomy pouch.
  • the use of a foam layer containing the thermoplastic elastomer avoids having to apply a separate adhesive to the foam substrate for bonding the flange to the ostomy pouch, which is typically used.
  • a separate processing step of applying an adhesive to the first face 41 of the foam substrate 40 is not required and the problem of separating ostomy flanges that stick together when stacked is avoided.
  • the foam layer containing the thermoplastic elastomer can be applied to the foam substrate in any known fashion, such as by heating and flowing the thermoplastic elastomer and applying it to the foam substrate.
  • the thermoplastic elastomer When cooled to about room temperature (i.e. about 23 °C), the thermoplastic elastomer is not tacky.
  • the foam layer containing the thermoplastic elastomer can be applied to the foam substrate in a processing step that is separate from and prior to a bonding step, wherein the foam substrate is bonded with the ostomy pouch. Because the thermoplastic elastomer is not tacky when at room temperature, the ostomy flanges can be subject to additionally processing steps after application of the foam layer containing the thermoplastic elastomer to the foam substrate.
  • the foam layer containing the thermoplastic elastomer is used to weld the foam substrate to the ostomy pouch and thus is designed to provide adequate seal strength between the ostomy pouch and the foam substrate to thereby prevent removal of the foam substrate from the ostomy pouch during regular use by an ostomy patient.
  • the foam layer containing the thermoplastic elastomer is welded to the first face of the foam substrate.
  • a thermoplastic elastomer foam layer that has been previously formed is brought into contact with the foam substrate and welded to the foam substrate by using at least one of heat and pressure, for example.
  • Heating can be accomplished by any means such as forced air heating, radio frequency heating, UV heating, heat impulse, or other heating that brings the thermoplastic elastomer to a temperature above its glass transition temperature.
  • Pressure can include mechanically pressing the foam layer containing the thermoplastic elastomer between the foam substrate and the adhesive layer. Such application of pressure may itself heat the thermoplastic elastomer above its glass transition temperature.
  • a foam layer containing the thermoplastic elastomer is melted and coated to the first face of the foam substrate and then cooled to form the thermoplastic elastomer containing foam layer. Formation of the foam layer containing the thermoplastic elastomer can be accomplished using conventional thermoplastic converting equipment.
  • the foam layer containing the thermoplastic elastomer is shown in several figures to at least partially define hole 13 in the flange 10.
  • the foam layer containing the thermoplastic elastomer may be substantially continuous, and may not define hole 13. Rather, hole 13 may be formed by an ostomy patient just prior to application to the peristomal skin.
  • the foam layer containing the thermoplastic elastomer may include one or more thermoplastic elastomers and other ingredients as desired for a particular application.
  • the foam layer containing the thermoplastic elastomer comprises polyethylene foam and ethylene vinyl acetate thermoplastic elastomer.
  • the foam layer containing the thermoplastic elastomer comprises polyethylene foam and ethyl methacrylate thermoplastic elastomer. Thermoplastic Elastomer
  • the ostomy flange can include a thermoplastic elastomer layer.
  • the thermoplastic elastomer layer is used to weld the ostomy flange to an ostomy pouch, which in several embodiments, comprises a polymer film construction. Therefore, in one embodiment the thermoplastic elastomer layer is designed to weld the ostomy flange to these types of polymer film constructions, among others.
  • the thermoplastic elastomer layer can be a film or have a polymer film construction.
  • the composition of the thermoplastic elastomer layer is not particularly limited by the present subject matter and can include a thermoplastic elastomer (TPE) such as, but not limited to, ethylene vinyl acetate, ethyl methacrylate, polycaprolactone, polycarbonates, fluoropolymers, polypyrrole, ethylene acrylate, styrenic block copolymers (TPE-s), thermoplastic elastomer polyolefin blends (TPE-o), elastomeric polyolefin alloys (TPE-v or TPV), thermoplastic polyurethanes (TPU), thermoplastic vulcanizates, thermoplastic copolyester, thermoplastic polyamides, metallocene- catalyzed polyolefin plastomers & elastomers, reactor-made thermoplastic polyolefin elastomers, and combinations thereof.
  • TPE thermoplastic elastomer
  • TPE thermoplastic elastomer
  • thermoplastic elastomer layer can also be a combination of any of the above-noted elastomers, in any ratio.
  • the thermoplastic elastomer layer can also be multiple layers of different or the same thermoplastic elastomer.
  • the thermoplastic elastomer layer consists of ethyl methacrylate.
  • the thermoplastic elastomer layer is included to provide an adequate bond between the foam wafer and the ostomy pouch.
  • the use of a thermoplastic elastomer layer avoids having to apply a separate adhesive to the foam substrate for bonding the flange to the ostomy pouch, which is typically used. Thus, a separate processing step of applying an adhesive to the first face 41 of the foam substrate 40 is not required and the problem of separating ostomy flanges that stick together when stacked is avoided.
  • the thermoplastic elastomer can be applied to the foam substrate in any known fashion, such as by heating and flowing the thermoplastic elastomer and applying it to the foam substrate.
  • thermoplastic elastomer When cooled to about room temperature (i.e. about 23 °C), the thermoplastic elastomer is not tacky. In this way the thermoplastic elastomer layer can be applied to the foam substrate in a processing step that is separate from and prior to a bonding step, wherein the foam substrate is bonded with the ostomy pouch. Because the thermoplastic elastomer is not tacky when at room temperature, the ostomy flanges can be subject to additionally processing steps after application of the thermoplastic elastomer layer to the foam substrate.
  • the thermoplastic elastomer layer is used to weld the foam substrate to the ostomy pouch and thus is designed to provide adequate seal strength between the ostomy pouch and the foam substrate to thereby prevent removal of the foam substrate from the ostomy pouch during regular use by an ostomy patient.
  • the coating weight or thickness of the thermoplastic elastomer layer is not particularly limited by the present subject matter and the thickness can be about 10-200 ⁇ , about 50- ⁇ , or about 70 ⁇ . Alternatively, the coating weight can range from about 10-100 g/m 2 . In one aspect, the thermoplastic elastomer layer has a coating weight of about 25 g/m 2 .
  • the thermoplastic elastomer layer is welded to the first face of the foam substrate.
  • a thermoplastic elastomer film that has been previously formed is brought into contact with the foam substrate and welded to the foam substrate by using at least one of heat and pressure, for example.
  • Heating can be accomplished by any means such as forced air heating, radio frequency heating, UV heating, heat impulse, or other heating that brings the thermoplastic elastomer to a temperature above its glass transition temperature.
  • Pressure can include mechanically pressing the thermoplastic elastomer layer between the foam substrate and the adhesive layer. Such application of pressure may itself heat the thermoplastic elastomer above its glass transition temperature.
  • thermoplastic elastomer is melted and coated to the first face of the foam substrate and then cooled to form the thermoplastic elastomer layer. Formation of the thermoplastic elastomer layer can be accomplished using conventional thermoplastic converting equipment.
  • thermoplastic elastomer layer is shown in several figures to at least partially define hole 13 in the flange 10.
  • the thermoplastic elastomer layer may be substantially continuous, and may not define hole 13. Rather, hole 13 may be formed by an ostomy patient just prior to application to the peristomal skin.
  • the thermoplastic elastomer layer may include one or more thermoplastic elastomers and other ingredients as desired for a particular application.
  • the thermoplastic elastomer layer comprises ethylene vinyl acetate at a thickness of about 70 ⁇ , or at a coating weight of about 25 g/m 2 .
  • the thermoplastic elastomer layer comprises ethyl methacrylate at a thickness of about 70 ⁇ , or at a coating weight of about 25 g/m 2 .
  • the ostomy flange includes an adhesive layer provided to adequately bond the flange and the ostomy appliance to peristomal skin of an ostomy patient.
  • the adhesive layer is configured and designed to provide a seal around the stoma so that discharge from the stoma will not migrate through the seal to contact the peristomal skin, which may result in irritation to the peristomal skin.
  • the adhesive layer is designed so that discharge from the stoma will travel through the hole 13 in the flange, through the opening 112 in the pouch, and be collected in the interior 111 of the pouch 110. As such, the adhesive layer acts as a barrier coating for the peristomal skin.
  • the composition and thickness/coating weight of the adhesive layer is not particularly limited by the present subject matter, as long as the adhesive layer provides a sufficient bond between the ostomy appliance and the peristomal skin of an ostomy patient and provides adequate barrier protection for the peristomal skin.
  • the adhesive may be applied at a coating weight of from about 1 g/m 2 to 200 g/m 2 , about 5 g/m 2 to 150 g/m 2 , or about 10 g/m 2 to 100 g/m 2 depending on the end use envisioned and the type of adhesive used.
  • the adhesive layer may also be characterized by being present at a thickness of about .1 to 2.0 millimeters (mm).
  • the adhesive layer can be continuous as shown in several figures, or alternatively discontinuous, e.g. in form of a pattern of dots, spirals, or stripes.
  • the adhesive layer covers the second surface of the foam substrate. In one aspect, the adhesive layer is directly abutting the foam substrate. In another aspect, the adhesive layer is anchored to the foam substrate with a tie layer between the adhesive layer and the foam substrate.
  • the composition of the adhesive layer is not particularly limited by the present subject matter, and can include any adhesive suitable for direct contact with peristomal skin of a patient.
  • the adhesive layer can comprise one or more adhesives including removable pressure sensitive adhesives, for example acrylic-based adhesives, silicone-based adhesives, rubber-based adhesives, polyurethane- based adhesives, and other types of adhesives and/or agents.
  • the acrylic adhesive for use in the present subject matter may be a solvent-based acrylic adhesive and may be any pressure sensitive acrylic adhesive that is capable of adhering to mammalian skin and that is free of ingredients known to cause undue irritation or toxicity to mammals. These adhesives typically include one or more acrylate copolymers.
  • Useful acrylate copolymers may or may not be self-crosslinking and are formed from at least two monomers chosen from: (1) hydroxyalkyi esters of acrylic or methacrylic acid in which the alkyl group comprises 2 to 4 carbon atoms, such as 2-hydroxyethyl acrylate, 2-hydroxyethyl methacrylate, 2- hydroxypropyl acrylate and 2-hydroxypropyl methacrylate; (2) alkyl esters of acrylic or methacrylic acid in which the alkyl group of the ester comprises 4 to 18 carbon atoms, such as n-butyl acrylate or methacrylate, isopropyl acrylate or methacrylate, n-hexyl methacrylate and 2-ethylhexyl acrylate; (3) ⁇ , ⁇ -unsaturated monocarboxylic or dicarboxylic acids, their anhydrides and their alkyl or alkenyl esters in which the alkyl group contains from 1 to 3 carbon atoms
  • Silicone pressure sensitive adhesives include two major components; a polymer or gum, and a tackifying resin.
  • the polymer is typically a high molecular weight polydimethylsiloxane or polydimethyldiphenylsiloxane, that contains residual silanol functionality (SiOH) on the ends of the polymer chain, or a block copolymer including polydiorganosiloxane soft segments and urea terminated hard segments.
  • the tackifying resin may generally be a three-dimensional silicate structure that is endcapped with trimethylsiloxy groups (OSiMe 3 ) and also contains some residual silanol functionality.
  • Examples of rubber-based pressure sensitive adhesives may include those comprising solid rubbers such as linear or radial A-B-A block copolymers or mixtures of these A-B-A block copolymers with simple A-B block copolymers. These block copolymers can be based on styrene-butadiene, styrene- isoprene, and hydrogenated styrene-diene copolymers such as styrene ethylene-butylene.
  • Suitable styrene-diene copolymers are exemplified by a blend of linear styrene-isoprene-styrene triblock copolymer and linear styrene-isoprene diblock copolymer.
  • polyurethanes can include polyurethanes.
  • Polyurethanes may be produced by reacting a polyisocyanate with a polyalcohol (polyol).
  • the functional groups can be alkanes, esters, ethers, and other components.
  • Isocyanates can be aromatic, such as diphenylmethane diisocyanate (MDI) or toluene diisocyanate (TDI); or aliphatic, such as hexamethylene diisocyanate (HDI) or isophorone diisocyanate (IPDI).
  • MDI diphenylmethane diisocyanate
  • TDI toluene diisocyanate
  • HDI hexamethylene diisocyanate
  • IPDI isophorone diisocyanate
  • the adhesive layer can also comprise fluid absorbing adhesives such as hydrocolloid adhesives comprising a dispersion of a discontinuous phase of one or more water-soluble and/or water swellable absorbent polymers, in a continuous phase comprising a pressure sensitive adhesive as described above.
  • Hydrocolloid adhesives have a duality of attributes in that they are inherently adhesive and inherently absorbent. They are useful as wound dressings because they can be applied directly to open wounds and can be secured on the surrounding intact skin, and as skin barriers because they protect the peristomal skin of ostomy patients.
  • the hydrocolloid adhesive generally comprises a mixture comprising a continuous phase formed from a pressure sensitive adhesive matrix as described above, and a discontinuous phase comprising one or more natural or synthetically derived water soluble and/or water insoluble absorbents.
  • the hydrocolloid adhesive is tacky at room temperature as well as at the skin temperature of ostomy patients.
  • the adhesive is dermatologically acceptable, which means that after continuous contact with skin there is little adhesive residue upon removal and there is no significant reaction with the skin during the adhesion period.
  • the adhesive strength of the continuous phase must be sufficient to adhere to the skin of the patient for the time determined by the use of the ostomy appliance.
  • Suitable permanently tacky pressure sensitive adhesive components may be used singly or in admixture, and include natural rubber, polyisobutylene, styrene-diene block copolymers, styrene-hydrogenated diene block copolymers, butyl rubber, acrylic polymers, silicone rubber, polyurethane rubber, polyvinyl ether and other like substances.
  • the discontinuous phase may comprise one or more hydrophilic polymers that are soluble or insoluble but swellable in water as the moisture-absorbing component.
  • One or more swellable polymers may be present.
  • Suitable insoluble swellable polymers include but are not limited to cross- linked sodium carboxymethyl cellulose, crystalline sodium carboxymethyl cellulose, cross-linked dextran and starch-acrylonitrile graft copolymer.
  • the swellable polymer may also be a so-called "super absorbent" material such as starch sodium polyacrylate.
  • Other hydratable polymers such as gluten and polymers of methyl vinyl ether and maleic acid and derivatives thereof may also be included in the discontinuous phase.
  • Suitable water soluble polymers include sodium carboxymethyl cellulose, pectin, gelatin, guar gum, locust bean gum, collagen, karaya gum and the like.
  • the discontinuous phase may be included up to about 70% of the total weight of the adhesive, up to about 60% by weight of the adhesive, and may be comprised of any combination of soluble and/or insoluble absorbents.
  • Optional fillers such as silica and pigments and optional active ingredients such as epidermal growth factors and antimicrobial compounds may also be incorporated into the adhesive layer.
  • Silver sulfadiazine and benzalkonium chloride represent non-limiting examples of such antimicrobial ingredients.
  • essential oils such as, for example, lavender oil or tea tree oil may be added in amounts sufficient for efficacy.
  • Other active ingredients such as those that provide a warming or cooling sensation to the skin, for example capsaicin or menthol, may be added.
  • Optional skin moisturizing ingredients such as urea and polyols may be incorporated into the formulations of the instant subject matter.
  • Other ingredients such as tackifiers, plasticizers, and polymer stabilizers may be added to the continuous phase, to modify tack and optimize adhesion properties and to protect polymers from degradation during processing.
  • the hydrocolloid adhesive includes a continuous phase that may include a physically cross-linked solid rubber, which comprises a blend of A-B-A block copolymer, such as a styrene-isoprene-styrene block copolymer and a diblock copolymer such as styrene-butadiene, styrene-isoprene or a hydrogenated styrene-diene copolymer such as styrene/ethylene butylene, a compatible tackifying resin and a low-molecular weight polyisobutylene, and optionally modified by butyl rubber.
  • the discontinuous phase may comprise one or more hydrocolloids that are soluble and/or swellable in water.
  • the hydrocolloid adhesive may comprise a dispersion of a discontinuous phase of one or more water-soluble and/or water swellable absorbent polymers in a continuous phase comprising a mixture of thermoplastic elastomer, a compatible liquid rubber, a polyisobutylene and a low-molecular weight polybutene.
  • the adhesive layer comprises a hydrocolloid adhesive, which can absorb discharge from stoma without significantly affecting the adhesive power of the adhesive layer.
  • the ostomy flange may further include a tie layer for anchoring the hydrocolloid adhesive to the foam substrate.
  • the adhesive layer of the ostomy flange may also include additives, such as filler, to adjust properties of the adhesive layer as desired for a particular application.
  • the adhesive of the instant subject matter can also be stabilized against UV and oxidative degradation by using UV stabilizers and antioxidants.
  • the adhesive layer 20 may have an exposed surface defining the skin contacting side 11 of the ostomy flange 10, which may be covered by a release liner 60 as shown in FIG. 2 and FIG. 4 to protect the adhesive layer foam contamination.
  • the ostomy flange may include a tie layer for anchoring the adhesive layer to the foam substrate.
  • a tie layer may increase the bonding strength between the hydrocolloid adhesive and the foam substrate.
  • a tie layer is not necessarily included in the ostomy flanges.
  • a tie layer may not be needed when the adhesive layer sufficiently bonds to the foam substrate so that the foam substrate will not detach from the adhesive layer during normal use by an ostomy patient.
  • the tie layer may be included if a sufficient bond is not established between the adhesive layer and the foam substrate.
  • the composition and thickness of the tie layer is not particularly limited by the present subject matter and can include any adhesive material that sufficiently anchors the adhesive layer to the foam substrate.
  • the tie layer can comprise contact adhesives, drying adhesives, pressure sensitive adhesives, hot melt adhesives, reactive adhesives, or combinations thereof. Further, the tie layer may be present at a coating weight ranging from about 5 - 200 g/m 2 , or about 10 - 100 g/m 2 . In one aspect, the tie layer comprises a hot melt adhesive being present at a coating weight of about 50 g/m 2 .
  • the ostomy flange may also include a release liner covering the adhesive layer to protect the adhesive layer from contamination prior to application of the ostomy flange to peristomal skin of an ostomy patient.
  • the release liner is not particularly limited by the present subject matter and can be of any shape or size that appropriately covers an exposed surface of the adhesive layer to prevent contamination of the adhesive layer.
  • Suitable release liners include for example, a backing layer of paper or polymer film, such as super calendered glassine or a polyethylene terephthalate film that may have a siliconized surface or other detackified surface designed for easy removal from the adhesive layer.
  • the shape, thickness, configuration, and composition of the release liner are not particularly limited by the present subject matter. As shown in FIGS. 2 and 4, the release liner is shaped and sized to extend over an edge of the ostomy flange as illustrated. However, such configuration is not required and the release liner may extend to, or short of the edge of the ostomy flange.
  • the release liner may also include indicia 61 (FIG. 3) visible to an ostomy patient, wherein such indicia may be printed or otherwise applied to the release liner.
  • indicia 61 may include for example, concentric circles visible on a face of the release liner that provide a guide for making a hole in the flange, for example hole 13 in the flange 10, having a size relative to the size of a stoma.
  • the concentric circles provided on the release liner may be used to create the hole 13 in the ostomy flange having a particular size associated with the chosen concentric circle.
  • the release liner is shown in several figures to be a substantially continuous liner applied over the flange.
  • the release liner may itself include a hole therethrough that is aligned with hole 13 in the flange, if present.
  • the release liner may be removed prior to application of the appliance to the peristomal skin of an ostomy patient.
  • the release liner comprises a siliconized polyethylene terephthalate film with a thickness of about 36 ⁇ .
  • the ostomy flange of the present subject matter can include other layers, additives within or separate from the described layers, or treatments and can include printing, printing receptive layers or treatments, a backing layer, a stiffening layer to impart a convex shape to the flange and make the flange more rigid so that the flange can be pressed into the peristomal skin in the case of a recessed stoma, hydrophobic layers or treatments, additional laminated film layers, or the like. Examples include priming, printing, hydrophobic treatments, etc. Additives, including air and/or oxygen scavengers, slip and antiblock agents, antifogs, antistatics, and processing aids can also be used.
  • the described layers can be coextruded, blended, or laminated with other layers including metal foils, other polymers films, fillers, adhesive/tie layers, or the like.
  • the flange described herein can be used in conjunction with an ostomy pouch to provide an ostomy appliance for the collection of discharge from a stoma.
  • One particular ostomy appliance in accordance with the present subject matter is shown in FIGS. 3, 4, and 7.
  • the ostomy flange 10 is bonded to an ostomy pouch 110.
  • the ostomy pouch is not particularly limited by the present subject matter and can include flexible or rigid containers as desired for a particular application.
  • the pouch can be of any size and shape and can be a flexible bag type contained as depicted in FIGS. 34, and 7.
  • the pouch includes a rigid container for collecting discharge from a stoma.
  • the foam can fill the space between a rigid pouch and contours in peristomal skin of a patient.
  • the ostomy flange is welded to an ostomy pouch to thereby produce an ostomy appliance. Because the thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer is previously applied to the foam substrate and cooled to room temperature to be non-tacky, a separate adhesive does not have to be applied immediately prior to welding the flange and pouch.
  • the ostomy appliance, thus formed can be used by an ostomy patient to collect and temporarily store discharge from a stoma. Because the thermoplastic elastomer layer is included, the situation can be avoided where an adhesive would otherwise be necessary to bond the flange to the pouch and which would cause stacked flanges to stick together.
  • the ostomy pouch is not particularly limited by the present subject matter and can include any type, shape, and size of flexible or rigid container, or com bination thereof.
  • Flexible containers may include bags, pouches, or other containers capable of housing discharge from a stoma.
  • the flexible containers can be made from polymeric film structures that are single- or multi-layer constructions and can include non-woven fabric layers.
  • Rigid containers can include boxes, envelopes, hollow spheres, or other rigid or semi-rigid container capable of housing discharge from a stoma.
  • the ostomy pouch can also include a com bination of rigid and flexible containers or parts.
  • the ostomy pouch includes a polymer film that can be welded with the foam wafer by using the thermoplastic elastomer layer positioned therebetween.
  • the ostomy pouch comprises a multi-layer polymeric film construction as described in WO 2013/028398, which is incorporated herein by reference.
  • a suitable multi layer film used for the ostomy pouch is InteliShieldTM Barrier Film, provided by Avery Dennison Corporation of Glendale, California which can be sealed to itself to form a container by heat, heat impulse and RF welding techniques.
  • the ostomy pouch 110 can include a drain 113 for removing stoma discharge collected in the interior 111 of the container.
  • the pouch or the flange may additionally include odor filters, or odor blocking/barrier layers or other components to reduce or eliminate odor emanated from the discharge of the stoma.
  • a method of making an ostomy flange includes providing a foam substrate, e.g. a foam washer, defining a first face and a second face.
  • a foam substrate e.g. a foam washer
  • the first face and the second face are oppositely directed, such as the configuration shown in FIG. 2, wherein the first surface 41 is oppositely directed from the second surface 42 of the foam layer 40.
  • the method includes laminating a thermoplastic elastomer film or foam layer containing the thermoplastic elastomer to the first face of the foam washer.
  • Such lamination includes bringing the thermoplastic elastomer film or foam layer containing the thermoplastic elastomer into contact with the foam washer and applying heat and/or pressure to the thermoplastic elastomer film or foam layer containing the thermoplastic elastomer so that the thermoplastic elastomer film or foam layer containing the thermoplastic elastomer is raised to a temperature above the glass transition temperature of the thermoplastic elastomer in the film or thermoplastic elastomer containing foam layer.
  • the foam washer can include a hole passing through the foam washer from the first face to the second face. Alternatively, the foam washer may not include such hole and may be a substantially continuous foam layer, such as a foam plate for example.
  • thermoplastic elastomer film can be applied to the foam substrate in other manners such as a coating method, wherein for example the thermoplastic elastomer is melted and applied to the foam washer in liquid form.
  • the thermoplastic elastomer or foam layer containing the thermoplastic elastomer may be applied as a separate film, wherein the film has been previously formed, and then laid over the first surface of the foam washer.
  • the heating and application of the thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer to the first surface of the foam washer welds or laminates the thermoplastic elastomer layer to the foam washer.
  • Heating can include heated air, heat impulse and radio frequency ( F) welding techniques for example. In several embodiments, heating does not degrade the foam substrate, such as by carbonizing the foam substrate.
  • F radio frequency
  • thermoplastic elastomer film or foam layer containing the thermoplastic elastomer may be allowed to cool, thus providing a solidified thermoplastic elastomer layer on the foam washer.
  • the thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer may be cooled to about room temperature (i.e. about 23 °C) to thereby bond with the foam washer.
  • the thermoplastic elastomer layer or thermoplastic elastomer containing foam layer thus cooled, does not require a release liner because it is non-tacky at this temperature. However, a release liner may nevertheless be used to cover the exposed surface of the thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer as desired.
  • the method also includes applying an adhesive layer to the second face of the foam washer.
  • the adhesive may include a hydrocolloid adhesive.
  • bonding can include using a tie material or tie layer situated between the second face of the foam washer and the hydrocolloid adhesive.
  • the tie layer is used to anchor the adhesive layer to the foam washer.
  • Such tie layer is used to prevent the hydrocolloid adhesive from separating from the foam washer during normal use of the ostomy flange, for example when used as part of an ostomy appliance.
  • the method can further include covering an exposed surface of the adhesive layer with a release liner. When the exposed surface of the adhesive layer defines the skin contacting side of the ostomy flange, then the release liner covers the skin contacting side of the ostomy flange.
  • the resulting flange may be welded to an ostomy pouch, e.g. a pouch comprising a polymer film, by heating the thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer to a tem perature above its glass transition temperature and pressing the thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer against the ostomy pouch.
  • Heating can include heated air, heat impulse and radio frequency ( F) welding techniques for example. In several em bodiments, heating does not degrade the foam substrate, such as by carbonizing the foam substrate.
  • a method of making an ostomy appliance includes providing a pouch defining an interior and including an opening providing access to the interior.
  • the pouch is not particularly limited and can include a flexible polymer film as previously described.
  • the opening in the pouch is also not particularly limited and can be any size sufficient to accommodate stomas of an ostomy patient.
  • the method includes providing a foam substrate, for example a foam wafer defining a first surface and a second surface and including an adhesive layer covering the second surface.
  • the adhesive layer can be a continuous adhesive layer or can be a layer having discontinuities such as a patterned layer of adhesive.
  • the adhesive can be applied in any known manner, such as roll coating, curtain coating, or extrusion for example.
  • the method includes welding the first surface of the foam wafer with an outer surface of the pouch.
  • Welding can include positioning a thermoplastic elastomer or foam layer containing the thermoplastic elastomer between the first surface of the foam wafer and the outer surface of the pouch.
  • Welding can also include pressing the foam wafer and the pouch together while the thermoplastic layer or foam layer containing the thermoplastic elastomer is at a temperature above its glass transition temperature.
  • thermoplastic layer or foam layer containing the thermoplastic elastomer When the thermoplastic layer or foam layer containing the thermoplastic elastomer is cooled below its glass transition temperature, a weld is formed between the first surface of the foam wafer and the outer surface of the pouch and bonds the ostomy flange to the ostomy pouch to thereby produce an ostomy appliance.
  • the weld between the flange and pouch surrounds the opening of the pouch.
  • the adhesive layer covering the second surface of the foam wafer may be anchored to the foam wafer by means of a tie layer situated between the adhesive layer and the foam wafer.
  • the tie layer may be included when the adhesive layer comprises a hydrocolloid adhesive and the foam layer comprises polyethylene foam.
  • the method can also include forming a hole in the foam wafer and through the adhesive layer and thermoplastic elastomer layer or thermoplastic elastomer containing foam layer.
  • the method need not include the formation of such hole. Rather, the hole can be formed after production of the ostomy appliance, and can be formed later by an ostomy patient just prior to application of the ostomy appliance over a stoma.
  • the method includes aligning the hole in the wafer with the opening in the pouch. In this way, discharge from a stoma of an ostomy patient may travel through the hole and through the opening in the pouch to be collected in the interior of the pouch.
  • a method of adhering an ostomy flange to an ostomy pouch includes providing an ostomy pouch defining an interior and including an opening providing access to the interior.
  • the method also includes providing an ostomy flange including a foam wafer defining a first face and a second face.
  • the ostomy flange includes a thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer covering the first face of the foam wafer.
  • the ostomy pouch may include a polymer film construction.
  • the method includes welding the ostomy flange to the ostomy pouch by pressing together the ostomy flange and the ostomy pouch while the thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer is above a glass transition temperature of the thermoplastic elastomer. Pressing and heating operations may be conducted at the same time or may be conducted separately. The pressing operation may be performed for example, after, during, or before heating the thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer above its glass transition temperature. In one embodiment, the thermoplastic elastomer layer or foam layer containing the thermoplastic elastomer maintains a temperature above the glass transition temperature of the thermoplastic elastomer during pressing operations. Alternatively, the method can include only one of pressing and heating.
  • the ostomy flange does not include opening 13 that is depicted in the figures. Rather, the ostomy flange may include a substantially continuous foam layer, tie layer, adhesive layer, and thermoplastic elastomer layer or thermoplastic elastomer containing foam layer. In this aspect, the ostomy flange seals the opening of the ostomy pouch when the ostomy flange is welded to the ostomy pouch. In another aspect, a weld created between the ostomy flange and ostomy pouch surrounds the opening in the ostomy pouch.
  • the ostomy flange may include an adhesive layer covering the second face of the foam wafer.
  • the adhesive layer includes a hydrocolloid adhesive.
  • the ostomy flange may also include a tie layer anchoring the adhesive layer to the foam wafer.
  • the ostomy flange can include a release liner covering the adhesive layer. If included, the release liner is removed from the adhesive layer prior to applying the ostomy appliance to the peristomal skin of an ostomy patient. Examples
  • Example 1 A representative ostomy flange in accordance with the present subject matter was produced, wherein a polyethylene foam substrate of TLS1801 (100 kg/m 3 - 1.0mm thick) from Sekisui Alveo of Luzern, Switzerland was laminated with a 25g/m 2 ethylene vinyl acetate film (lamination done by Sekisui Alveo). A tie layer of T2101 (50 g/m 2 ) hot melt adhesive from Avery Dennison Corporation of Glendale, California along with a BG 5200 paper liner also from Avery Dennison Corporation was coated onto a side of the foam substrate opposite from the ethylene vinyl acetate film.
  • a hydrocolloid adhesive of H2410 (0.5 mm thickness) available from Avery Dennison Corporation was extruded onto a polyethylene terephthalate matt liner (36 ⁇ thickness) of Silphan L3 36 M 3 11017 Clear Matte available from Siliconature S.p.A. and a liner of OPP1060 from Avery Dennison Corporation was laminated thereto.
  • the OPP1060 liner was then removed from the hydrocolloid adhesive and the BG 5200 liner was removed from the tie layer of T2101 hot melt adhesive, and the two exposed layers were laminated together on a conversion line.
  • a kiss-cut followed by a cut-through separated the laminate construction into individual flanges.
  • Examples 2-10 Several ostomy flanges in accordance with the present subject matter were prepared for determining the weld strength between the flanges and an ostomy pouch.
  • the several flanges, listed as Examples 2-10 were prepared by taking a foam substrate laminated with an ethylene vinyl acetate film (EVA) as received from Sekisui Alveo as in Example 1, and laminating a hydrocolloid adhesive and liner construction of M ED 2190H available from Avery Dennison Corporation onto a side of the foam opposite from the EVA film.
  • EVA ethylene vinyl acetate film
  • Ostomy flanges of MED 9651H from Avery Dennison Corporation which include a polyethylene foam substrate, hydrocolloid adhesive layer, and release liner, were used for comparison.
  • the hydrocolloid adhesive layer in the comparative examples 11-13 had the same hydrocolloid thickness as Examples 2-10.
  • the foam is slightly deformed and this causes the formation of a small channel in the hydrocolloid adhesive layer. This might be due to the level of applied pressure and the bottom side of the heat sealing apparatus being not flat and smooth.
  • Comparative The film can be removed by hand from the foam.
  • the film cannot be removed from the foam, although some spots seems to be less welded than others (i.e. partial removability of the film).
  • Foam failure is not desirable, because foam failure is an indication that the foam substrate has undergone degradation due to the heat applied for making the weld. Nevertheless, the seal strength in the sealing direction (and mainly the peak value) is lower for the foam without EVA than for the foam with EVA. This data confirms that the foam splits more easily when higher temperatures (e.g. 120 - 130°C) are applied and confirms that these higher temperatures cause damages to the foam. Accordingly, such high temperatures should not be used to weld such foam flanges to InteliShield film.
  • higher temperatures e.g. 120 - 130°C
  • EVA film laminated onto the foam substrate facilitates the welding of the foam to the InteliShield ostomy film.
  • the data shows that a temperature of 130°C applied for 5 seconds fails to create a uniform seal across the entire sealed surface and causes heavy foam deformation and damage and results in easy foam failure on the sealed surface due to foam degradation.
  • a temperature of 110°C applied for 3 seconds is sufficient to produce a uniform seal with sufficient seal strength between the InteliShield film and the foam substrate having EVA.
  • Example 14 A representative ostomy flange in accordance with the present subject matter was produced, wherein a polyethylene foam substrate of TLS1801 (100 kg/m 3 - 1.0mm thick) from Sekisui Alveo of Luzern, Switzerland was laminated with a 25g/m 2 ethyl methacrylate film (lamination done by Sekisui Alveo). A tie layer of T2101 (50 g/m 2 ) hot melt adhesive from Avery Dennison Corporation of Glendale, California along with a BG 5200 paper liner also from Avery Dennison Corporation was coated onto a side of the foam substrate opposite from the ethyl methacrylate film.
  • a hydrocolloid adhesive of H2410 (0.5 mm thickness) available from Avery Dennison Corporation was extruded onto a polyethylene terephthalate matt liner (36 ⁇ thickness) of Silphan L3 36 M 3R11017 Clear Matte available from Siliconature S.p.A. and a liner of OPP1060 from Avery Dennison Corporation was laminated thereto.
  • the OPP1060 liner was then removed from the hydrocolloid adhesive and the BG 5200 liner was removed from the tie layer of T2101 hot melt adhesive, and the two exposed layers were laminated together on a conversion line.
  • a kiss-cut followed by a cut-through separated the laminate construction into individual flanges.
  • Examples 15-19 Several ostomy flanges in accordance with the present subject matter were prepared for determining the weld strength between the flanges and an ostomy pouch.
  • the several flanges, listed as Examples 15-19 were prepared by taking a foam substrate laminated with an ethyl methacrylate film (EMA) as received from Sekisui Alveo as in Example 1, and laminating a hydrocolloid adhesive and liner construction of MED 2190H available from Avery Dennison Corporation onto a side of the foam opposite from the EVA film.
  • EMA ethyl methacrylate film
  • laminating conditions i.e. temperature and sealing time
  • pressure applied to the construction during welding operations.
  • a one-sided heat sealing apparatus is used to avoid heating of the hydrocolloid adhesive layer, wherein such heating can lead to the undesirable formation of channels in the hydrocolloid adhesive layer.
  • the bottom surface of the heat sealer may be flat and smooth to avoid forming channels in the hydrocolloid adhesive layer.
  • the present subject matter includes all operable combinations of features and aspects described herein. Thus, for example if one feature is described in association with an embodiment and another feature is described in association with another embodiment, it will be understood that the present subject matter includes embodiments having a combination of these features. [0121] As described hereinabove, the present subject matter solves many problems associated with previous strategies, systems and/or devices. However, it will be appreciated that various changes in the details, materials and arrangements of components, which have been herein described and illustrated in order to explain the nature of the present subject matter, may be made by those skilled in the art without departing from the principle and scopes of the claimed subject matter, as expressed in the appended claims.

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Abstract

L'invention concerne des brides de stomie à base de stratifié élastomère à mousse thermoplastique. De telles brides permettent une soudure facile à des poches de stomie, sans nécessiter d'application distincte d'adhésif juste avant la liaison de la bride avec une poche de stomie. Les brides de stomie comprennent un substrat en mousse ayant une couche élastomère thermoplastique sur un côté ou deux substrats en mousse, le second contenant l'élastomère thermoplastique. Une couche adhésive est incluse sur un côté du substrat en mousse à l'opposé de la couche élastomère thermoplastique. Une couche de liaison peut être incluse pour ancrer la couche adhésive sur le substrat en mousse. La bride peut être soudée à une poche de stomie par l'application de chaleur et/ou de pression pour former un appareil de stomie qui peut être appliqué à la peau péristomiale d'un patient de stomie pour collecter l'évacuation d'une stomie.
PCT/US2015/055893 2014-10-16 2015-10-16 Brides de stomie à base de stratifié élastomère à mousse thermoplastique pour une soudure facile à une poche de stomie WO2016061434A1 (fr)

Applications Claiming Priority (4)

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US201462064728P 2014-10-16 2014-10-16
US62/064,728 2014-10-16
US201562139185P 2015-03-27 2015-03-27
US62/139,185 2015-03-27

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3541332B1 (fr) * 2016-11-21 2024-03-06 Hollister Incorporated Barrière de stomie

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4813942A (en) * 1987-03-17 1989-03-21 Bioderm, Inc. Three step wound treatment method and dressing therefor
EP0317326A2 (fr) * 1987-11-19 1989-05-24 Hollister Incorporated Instrument d'ostomie et son anneau convexe de pression
US20060276763A1 (en) * 1995-02-17 2006-12-07 E.R. Squibb & Sons. Inc. Ostomy system with repositionable pouch
WO2013028398A1 (fr) 2011-08-19 2013-02-28 Avery Dennison Corporation Films formant barrière
GB2509752A (en) * 2013-01-14 2014-07-16 Pelican Healthcare Ltd An ostomy pouch assembly

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4813942A (en) * 1987-03-17 1989-03-21 Bioderm, Inc. Three step wound treatment method and dressing therefor
EP0317326A2 (fr) * 1987-11-19 1989-05-24 Hollister Incorporated Instrument d'ostomie et son anneau convexe de pression
US20060276763A1 (en) * 1995-02-17 2006-12-07 E.R. Squibb & Sons. Inc. Ostomy system with repositionable pouch
WO2013028398A1 (fr) 2011-08-19 2013-02-28 Avery Dennison Corporation Films formant barrière
GB2509752A (en) * 2013-01-14 2014-07-16 Pelican Healthcare Ltd An ostomy pouch assembly

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3541332B1 (fr) * 2016-11-21 2024-03-06 Hollister Incorporated Barrière de stomie

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