Ostomy body attachment

Abstract

The present invention relates to an ostomy body attachment for forming a seal between an ostomy appliance and an ostomy of an ostomy person. An ostomy body attachment has an adhesive pad and a first removable release layer adhered to a first side of the adhesive pad. The adhesive pad has a stoma aperture formed therethrough. The first removable release layer includes an image on a surface thereof. The image is at least partially occluded by a portion of the ostomy body appendage when viewed from a second side of the adhesive pad opposite the first side with the ostomy body appendage in an unused state. The portion is movable between a first position in an unused state and a second position in which an image is at least partially revealed through the stoma aperture when viewed from the second side of the adhesive pad.

Description

TECHNICAL FIELD

[0001] The present invention relates to an ostomy body attachment for forming a seal between an ostomy appliance and a stoma of an ostomate. BACKGROUND

[0002] People who are unable to naturally excrete waste due to illness or injury can require a colostomy, ileostomy or urostomy. A colostomy or ileostomy involves attaching a section of the colon or small intestine, respectively, to an opening in the abdominal wall. A urostomy involves attaching a section of the urinary system to the abdominal wall in cases where urine cannot be drained through the bladder and urethra. In each case, a stoma is formed at the opening protruding from the abdominal wall for excreting waste from the body.

[0003] Ostomy appliances typically comprise a skin barrier or ostomy body attachment having a stoma hole therein and a pouch for collecting excreted waste. The ostomy body attachment of the ostomy appliance can be adhered to the body of the person around the stoma by an adhesive for collecting waste excreted from the stoma into the pouch. The ostomy appliance can be provided as a single piece comprising both the ostomy body attachment and the pouch in a single pouch system. Alternatively, the ostomy appliance can be provided as a multi-piece, for example two-piece, pouch system in which the ostomy body attachment and the stoma pouch are separate components that can be attached together. For a multi-piece system, the ostomy body attachment can be first affixed to the body of the ostomate around the stoma and the pouch can be affixed to the ostomy body attachment to form the ostomy appliance for collecting waste. Regardless of the system employed, it is important that an effective seal is formed between the stoma and the ostomy appliance to prevent leakage of excreted waste.

[0004] As the ostomy appliance is typically fitted by the patient themselves, it is also important to provide the user with an easy, safe, reliable method of attaching the ostomy appliance to the body without discomfort. Furthermore, as ostomy appliances are not aesthetically pleasing, it is important to ensure that these devices are as discreet as possible.

[0005] Reference is made to EP1378219 in which an ostomy appliance is described that incorporates a formable adhesive that can be manipulated to form a customised form fit around the stoma of the wearer.

[0006] Reference is also made to Figures 1 to 3, in which a prior art skin barrier or ostomy wafer 1 is depicted for providing a seal between a user and an ostomy appliance comprising a three-layer laminate 3 having a centrally located stomal hole 5. The three-layer laminate comprises a first, skin-facing lower layer 7 comprising an adhesive for attaching the device to the skin of a patient, a second, elastic intermediate layer 9 having a degree of memory so as to spring back and fit / wrap around a stoma, and a third, pouch-facing upper layer 11 comprising a viscous hydrocolloid material which is inflatable and wraps around the stoma when in use. A removable release layer or inner liner (not shown) can be attached to the skin-facing layer 7 and the pouch-facing layer 11 to protect the respective layers until the device is installed by the user.

[0007] The ostomy wafer 1 is intended to be installed according to a procedure comprising a number of consecutive handling steps. The handling steps include removal of the release layer from the pouch-facing layer 11 and rolling the three-layer structure 3 outwards and upwards from the inner edge 13 of the stomal hole 5, as shown in Figure 2, forming a raised collar or "high collar neck ring" 15. As shown in Figure 3, the device is adhered to the skin of a patient with the stoma 17 extending through the stomal hole 5 of the wafer 1, the rolled collar 15 extending upwards from the pouch-facing layer 11 and wrapping the outer wall of the stoma 17 in a snug manner. A pouch (not shown) can then be adhered to the ostomy wafer 1 by means of the adhesive surface of the pouch-facing layer 11, thereby forming a secure and reliable seal between the stoma 17 and the final ostomy appliance.

[0008] As mentioned above, one problem with the prior art ostomy wafer is that the user has difficulties following the multi-step application procedure, even if instructions are included. Thus, the user often removes the wrong release layer at the wrong time and / or rolls the device in the wrong direction. This can result in the device being applied incorrectly, with the collar extending inwards towards the user and / or with the wrong adhesive side adhered to the skin of the user. Incorrect application of the ostomy wafer can compromise the sealing effect between the ostomate and the ostomy appliance, resulting in undesired leakage and discomfort for the ostomate.

[0009] The present invention seeks to provide an improved ostomy wafer which at least alleviates the above-mentioned problems. SUMMARY

[0010] The present invention provides an ostomy wafer according to the appended claims.

[0011] The present invention provides an ostomy body attachment. The ostomy body attachment can be suitable for forming a seal between an ostomy appliance and a stoma of a ostomate. The ostomy body attachment can comprise an adhesive pad. A first removable release layer can be adhered to a first side of the adhesive pad. The adhesive pad can comprise a stoma hole formed therethrough. The first removable release layer can comprise an image on a surface thereof. The image can be at least partially hidden by a portion of the ostomy body attachment when the ostomy body attachment is in an unused state. The image can be at least partially hidden by the portion of the ostomy body attachment when viewed from a second side of the adhesive pad opposite the first side. The portion can be movable between a first position in the unused state and a second position in which the image is at least partially revealed when viewed from the second side of the adhesive pad (e.g. through the stoma hole).

[0012] Thus, a first aspect of the present invention provides an ostomy body attachment for forming a seal between an ostomy appliance and a stoma of an ostomate, the ostomy body attachment comprising an adhesive pad comprising a stoma hole formed therethrough and a first removable release layer adhered to a first side of the adhesive pad, wherein the first removable release layer comprises an image on a surface thereof, wherein, in an unused state, the image is at least partially hidden by a portion of the ostomy body attachment when viewed from a second side of the adhesive pad opposite the first side, and wherein the portion is movable between a first position in the unused state and a second position in which the image is at least partially revealed when viewed from the second side of the adhesive pad.

[0013] Advantageously, the image can be hidden until it is required to be revealed to a user of the ostomy body attachment. This can be particularly useful when the image relates to one of a series of operational steps that are required to correctly apply the ostomy body attachment to the body of the ostomate. Where there is one or more other operational steps before the operational step indicated by the image, it is advantageous to hide the image until the operational step should be performed. This helps to ensure that the user of the ostomy body attachment performs each operational step in the correct order, thereby helping to ensure that the user correctly fits the ostomy body attachment to the ostomate. It is currently believed that a barrier to the use of certain ostomy body attachments (particularly those that form part of a two-piece pouch system and are to be adhered to the skin of the user on one side and subsequently to a pouch on the other side) is that the user does not understand, or even read, the instructions provided in the packaging in which the body attachment is provided. This can result, for example, in the incorrect side of the body attachment being adhered to the body of the user, or the attachment being flipped over in the wrong direction, thereby not sealing well to the user.

[0014] The portion of the ostomy body attachment that at least partially hides the image in the unused state can completely hide the image in the unused state.

[0015] The portion of the ostomy body attachment that at least partially conceals the portion of the image in the unused state can comprise a portion of the adhesive pad. The adhesive pad can be deformable to enlarge the size of the stoma hole. The adhesive pad and the first removable release layer can be relatively arranged such that the image is proximate to the edge of the stoma hole (when in the unused state). The adhesive pad and the first removable release layer can be relatively arranged such that when the adhesive pad is manipulated to a second position (in which the size of the stoma hole can be enlarged), the image is revealed.

[0016] The image can be located on a region of the surface of the first removable release layer that is between the boundary of the stoma hole in the unexpanded state and the boundary of the stoma hole in the maximally expanded state.

[0017] The adhesive pad can be deformable to enlarge the size of the stoma hole and the image can be located on a region of the surface of the first removable release layer that is between the boundary of the stoma hole in the unexpanded state and the edge of the stoma hole in the maximally expanded state.

[0018] In the first position, the image can be located on the surface of the first removable release layer within 10mm of the edge of the stoma hole. The image can be arranged within 5mm, 4mm, 3mm or 2mm of the edge of the stoma hole. The image can curve with the edge of the stoma hole such that it extends at least partially around the stoma hole.

[0019] The adhesive pad can be rollable / turnable (e.g. to enlarge the size of the stoma hole). The image can be revealed when the adhesive pad is turned outwards from the edge of the stoma hole. The image can be located on a region of the surface of the first removable release layer that is within the boundary of the stoma hole defined by the adhesive pad in the maximally turned out state.

[0020] The ostomy body attachment can further comprise a second removable release layer that is accessible / proximal from a second side of the adhesive pad. The portion of the ostomy body attachment that at least partially conceals the portion of the image in the unused state can comprise the second removable release layer, i.e. the second removable release layer is the moveable portion of the ostomy body attachment. The second removable release layer can comprise an adhesive sticker.

[0021] Thus, one preferred embodiment of the present invention provides an ostomy body attachment for forming a seal between an ostomy appliance and a stoma of an ostomate, the ostomy body attachment comprising an adhesive wafer, a first removable release layer adhered to a first side of the adhesive wafer, and a second removable release layer accessible from a second side of the adhesive wafer; the adhesive wafer comprising a stoma hole formed therethrough, wherein the first removable release layer comprises an image on a surface thereof, wherein, in an unused state, the image is at least partially concealed by the second removable release layer when viewed from the second side of the adhesive wafer opposite the first side, and wherein the second removable release layer is movable between a first position in the unused state and a second position in which the second removable release layer is removed from the remainder of the ostomy body attachment and the image is at least partially revealed through the stoma hole when viewed from the second side of the adhesive wafer.

[0022] The first removable release layer can comprise a further image that is at least partially concealed by the second removable release layer in the unused state. The first and second removable release layers can be relatively arranged such that, when the second removable release layer is removed from the remainder of the ostomy body attachment, the image and / or the further image is at least partially revealed.

[0023] The movement from the first position in the unused state to the second position in which the image is at least partially revealed through the stoma hole when viewed from the second side of the adhesive wafer can be removal of the second removable release layer.

[0024] Thus, one preferred embodiment of the present invention provides an ostomy body attachment for forming a seal between an ostomy appliance and a stoma of an ostomate, the ostomy body attachment comprising an adhesive wafer, a first removable release layer adhered to a first side of the adhesive wafer, and a second removable release layer accessible from a second side of the adhesive wafer; the adhesive wafer comprising a stoma hole formed therethrough, wherein the first removable release layer comprises an image on a surface thereof, wherein, in an unused state, the image is at least partially concealed by the second removable release layer when viewed from the second side of the adhesive wafer opposite the first side, and wherein the second removable release layer is movable between a first position in the unused state and a second position in which the second removable release layer is removed from the remainder of the ostomy body attachment and the image is at least partially revealed through the stoma hole when viewed from the second side of the adhesive wafer.

[0025] The second removable release layer can comprise one or more of a number, a letter, a graphical representation, and a pattern on a surface thereof and arranged to at least partially conceal the image and / or the further image in the unused state. The second removable release layer can be opaque.

[0026] Alternatively, the second removable release layer can be translucent. The translucency of the second removable release layer can make features of the adhesive pad contacting the release layer visible through the second removable release layer. The translucency of the second removable release layer can make features separated from the second removable release layer, for example features of more than 0.1 mm, 0.2 mm, 0.5 mm, 1 mm, invisible through the second removable release layer. The first removable release layer can be separated from the second removable release layer by at least 0.1 mm, 0.2 mm, 0.5 mm, 1 mm or 2 mm, for example by the thickness of the intervening adhesive pad. Thus, in the stoma hole region, there can be a gap of at least 0.1 mm, 0.2 mm, 0.5 mm, 1 mm or 2 mm between the first removable release layer and the second removable release layer. Thus, the image and / or the further image can be hidden in the unused state, because the translucency of the second removable release layer makes features on the first removable release layer invisible through the second removable release layer due to the gap in the stoma hole region.

[0027] The image and / or the further image can relate to an operational step in use of the ostomy body attachment. The first removable release layer can be arranged relative to the component such that the image and / or the further image is at least partially revealed after completion of one or more previous operational steps in use of the ostomy body attachment, which operational steps result in movement of the component from the first position to the second position.

[0028] The image can comprise indicia. The image / indicia can comprise one or more of a number, a letter, a graphical representation and a pattern. The image can comprise text that is to be followed / continued / completed when viewed from the second side of the adhesive pad. Thus, the text can be mirrored when viewed from a first side of the adhesive pad opposite the second side.

[0029] The stoma hole can be circular in the unused state. The stoma hole can be formed through the centre of the adhesive pad. The adhesive pad can be disc shaped. The adhesive pad can be substantially planar.

[0030] The adhesive pad can comprise a convex or concave profile. The adhesive pad can comprise a three layer laminate structure. The three layer laminate structure can comprise a skin facing layer, a pouch facing layer and a base layer between the skin facing layer and the pouch facing layer. The skin facing layer and the pouch facing layer can comprise adhesive. At least one of the skin facing layer and the pouch facing layer can be mouldable. The adhesive pad can comprise part of a two part ostomy appliance pouch system. The adhesive pad can be releasably attachable to an ostomy pouch.

[0031] In a second aspect, the present invention provides a method of forming a seal between an ostomy appliance and a stoma of an ostomate, comprising utilising an ostomy body attachment according to the first aspect of the present invention.

[0032] The method can comprise the step of moving a portion of the ostomy body attachment from a first position in an unused state to a second position in which the image is at least partially revealed through the stomal hole when viewed from the second side of the adhesive wafer. The method can comprise rolling up / turning up / lifting up a portion of the ostomy body attachment. In particular, the method can comprise rolling up the adhesive wafer to reveal the image.

[0033] The method can comprise the step of attaching a pouch of the ostomy appliance to the adhesive wafer. The pouch can be attached to the adhesive wafer after the adhesive wafer has been adhered to the body of the ostomate.

[0034] In a third aspect, the present application provides an ostomy appliance comprising an ostomy body attachment according to the first aspect of the present application. The ostomy appliance can further comprise an ostomy pouch. The ostomy pouch and the ostomy body attachment can be releasably attachable.

[0035] In a fourth aspect, the present application provides a method of manufacturing an ostomy body attachment, comprising the steps of:

[0036] forming an adhesive wafer defining a stomal hole;

[0037] applying an image to a release layer; and

[0038] adhering the release layer to a first side of the adhesive wafer such that, when viewed from a second side of the adhesive wafer opposite the first side, in an unused state, the image is at least partially concealed by a moveable portion of the ostomy body attachment;

[0039] wherein the moveable portion is moveable between a first position in an unused state and a second position in which, when viewed from the second side of the adhesive wafer, the image is at least partially revealed through the stomal hole.

[0040] The step of applying an image to a release layer can comprise printing or drawing the image.

[0041] The skilled person will appreciate that features described in relation to any one aspect, embodiment or example described herein can be applied to any other aspect, embodiment or example, except where such application is either mutually exclusive or the subject-matter of the prior art. Furthermore, any feature described herein can be applied to any aspect described herein and / or in combination with any other feature described herein, except where such application is either mutually exclusive or the subject-matter of the prior art. BRIEF DESCRIPTION OF DRAWINGS

[0042] For a more clear understanding of the application, one or more embodiments thereof will now be described with reference to the attached drawings, in which:

[0043] Figure 1 shows a perspective view of a schematic illustration of an existing ostomy body attachment;

[0044] Figure 2 shows a rendered perspective view of a user manipulating an existing stoma body accessory to form a stoma opening;

[0045] Figure 3 shows the stoma body accessory of Figure 2 when applied to the body of a stoma patient, so that the stoma extends through the stoma opening.

[0046] Figure 4 A perspective view showing an example stoma body accessory to which the present invention can be implemented;

[0047] Figure 5 A plan view of the stoma body accessory according to the present invention is shown;

[0048] Figure 6 It shows Figure 5 The diagram shows a plan view of the stoma body attachments, with the release liner removed;

[0049] Figure 7 It shows Figure 6 The diagram shows a plan view of the stoma body attachment, in which a portion of the stoma body attachment has been moved from a first position to a second position to increase the diameter of the stoma opening, and an instruction / guidance image is displayed on another release liner;

[0050] Figure 8 It shows Figure 7 The bottom view of the stoma body attachment shown, with another release liner removed;

[0051] Figure 9 It shows Figure 8 A plan view of the ostomy body parts and accessories shown;

[0052] Figure 10 It shows Figure 9 The diagram shows a plan view of a stoma body accessory that is attached to the stoma patient's body so that the stoma extends through the stoma opening of the stoma body accessory.

[0053] Figure 11 It shows Figure 10 The diagram shows a plan view of the adhesive pad of the stoma body accessory, with the last release liner removed;

[0054] Figure 12 It shows Figure 11 The diagram shows a plan view of an adhesive pad that is adhered to the body of the ostomy patient, with a portion of the ostomy apparatus bag attached to the adhesive pad.

[0055] Figure 13 A rendered perspective view of the ostomy body accessory according to the invention, housed within a sealed box, is shown;

[0056] Figure 14 A plan view of the ostomy body attachment is shown, with the release liner removed from the pouch, exposing the ostomy body attachment placed within the pouch; Figure 13 A plan view of the ostomy body attachment is shown, with the release liner removed from the pouch, exposing the ostomy body attachment placed within the pouch;

[0057] Figure 15 A plan view of the ostomy body attachment is shown, with the release liner removed from the pouch, exposing the ostomy body attachment placed within the pouch;

[0058] Figure 16 A plan view of the ostomy body attachment is shown, with the release liner removed from the pouch, exposing the ostomy body attachment placed within the pouch; Figure 15 A plan view of the ostomy body attachment is shown, with the release liner removed from the pouch, exposing the ostomy body attachment placed within the pouch;

[0059] Figure 17 A plan view of the ostomy body attachment is shown, with the release liner removed from the pouch, exposing the ostomy body attachment placed within the pouch; Figure 16 A plan view of the ostomy body attachment is shown, with the release liner removed from the pouch, exposing the ostomy body attachment placed within the pouch; DETAILED DESCRIPTION

[0060] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the various embodiments and the inventive concepts presented herein. However, those skilled in the art will understand that the present invention can be practiced without these specific details, or with an equivalent set of

[0061] In the following description, unless otherwise stated, "skin-facing / peri- skin" and "pouch-facing / peri-pouch" are to be understood in relation to the body of the user of the ostomy body attachment or "ostomate". For example, the peri-skin layer is to be understood as the layer intended to be adhered or attached to the skin of the ostomate, the pouch-facing layer / peri-pouch layer is to be understood as the layer facing away from the body of the ostomate when the peri-skin layer is adhered to the skin of the ostomate.

[0062] Figure 4An ostomy body attachment 101 of a two-piece pouch system is depicted for forming a seal between a stoma (not shown) and an ostomy pouch (not shown). The ostomy body attachment 101 comprises an adhesive wafer 102 having a three-layer structure 103. The three-layer structure 103 defines a stoma aperture 105 having an inner edge 113 for receiving a stoma 117 of a stomate. The stoma aperture 105 is generally circular in its initial undeformed state so as to substantially correspond to the generally circular outer wall of the stoma. The initial diameter of the stoma aperture 105 can be between 10 mm and 100 mm, preferably between 20 mm and 60 mm. Preferably, the stoma aperture 105 can be deformed from a first diameter to a second diameter, preferably by about 10 mm. In one form, the initial diameter of the stoma aperture 105 is generally about 20 mm and can be deformed to a diameter of about 30 mm. In another form, the initial diameter of the stoma aperture 105 is generally about 30 mm and can be deformed to a diameter of about 40 mm. In another form, the initial diameter of the stoma aperture 105 is generally about 40 mm and can be deformed to a diameter of about 50 mm.

[0063] The three-layer structure 103 of the adhesive wafer 102 comprises a skin-facing adhesive layer 107, an intermediate substrate layer 109 and a pouch-facing adhesive layer 111. The skin-facing adhesive layer 107 and / or the pouch-facing adhesive layer 111 are made from a flexible and / or moldable and / or formable adhesive. For example, both adhesive layers 107, 111 can comprise a medical grade adhesive such as a low sensitizing hydrocolloid. An example of a suitable adhesive is the adhesive produced by ConvaTec under the brand name DuoDERM®. This adhesive is generally tacky, putty-like, substantially inelastic, with low memory. The choice of adhesive can depend on the intended use of the ostomy appliance and its duration of application. For example, where the ostomy appliance comprises a closed pouch or bag for short-term wear or an open pouch or bag for short-term / medium-term wear, the skin-facing adhesive layer 107 can comprise a DuoDERM® adhesive. Where the ostomy appliance is intended for medium-term / long-term wear by an ileostomy or urostomy patient, both adhesive layers 107, 111 can comprise a more durable and For example, where the ostomy appliance comprises a closed pouch or bag for short-term wear or an open pouch or bag for short-term / medium-term wear, the skin-facing adhesive layer 107 can comprise a DuoDERM® adhesive. Where the ostomy appliance is intended for medium-term / long-term wear by an ileostomy or urostomy patient, both adhesive layers 107, 111 can comprise a more durable The pouch-facing side 111 can comprise a DuoDERM® adhesive. For example, where the ostomy appliance comprises a closed pouch or bag for short-term wear or an open pouch or bag for short-term / medium-term wear, the skin-facing adhesive layer 107 can comprise a DuoDERM® adhesive. Where the ostomy appliance is intended for medium-term / long-term wear by an ileostomy or urostomy patient, both adhesive layers 107, 111 can comprise a more durable At least one and preferably both adhesive layers 107, 111 are translucent so that the substrate layer 109 is visible from either or both sides of the ostomy body attachment 101.

[0064] The thickness of the skin-facing and pouch-facing adhesive layers 107, 111 is between about 0.3 mm and 1.5 mm. The thickness of the intermediate base layer 109 is between 0.2 mm and 1.0 mm, and is generally thinner than the thickness of the adhesive layers 107, 111 alone. In the illustrated embodiment, the thickness of the skin-facing adhesive layer 107 is 0.38 mm, the thickness of the base layer 109 is 0.2 mm, and the thickness of the pouch-facing adhesive layer is 1.14 mm. The pair of adhesive layers 107, 111 and the base layer 109 have a substantially uniform thickness throughout, and are substantially coextensive, i.e., they each extend through substantially the same area. In the illustrated embodiment, the three layers 107, 109, 111 are substantially disc-shaped, and each has an outer diameter of about 100 mm. Those skilled in the art will appreciate that one or more of the three layers 107, 109, 111 can have a variable thickness over its respective diameter, in order to create areas having different material properties, e.g., areas having different stiffness or surface shape.

[0065] Each adhesive layer 107, 111 is covered by a release layer 119, 121 in the form of a thin, circular sheet made of or coated with a suitable material such as silicone, in order to facilitate removal of the release layers 119 and 121 from the respective adhesive layers 107 and 111. Each release layer 119, 121 extends beyond the outer bounds of the adhesive layer 107, 111, and serves to protect the adhesive layers 107 and 111 until use of the ostomy body attachment 101 by an ostomate. Each release layer 119, 121 includes a small tab 123, 125 that protrudes from the outer edge of the respective release layer 119 and 121, to allow the user of the ostomy body attachment 101 to easily grasp the release layer 119, 121 and remove it from the respective adhesive layer 107, 111 when applying it to the stoma. As discussed further below, the release layers 119, 121 provide a surface on which one or more images (not shown) can be formed.

[0066] As used herein, an "image" can include one or more of a number, a letter, a graphical representation, and a pattern, and can be created by one or more color media that can have a variety of colors or contrasting textures.

[0067] While Figure 4The illustrated ostomy body attachment includes a single release layer 119, 121 to protect the respective adhesive layer 107, 111, but it is understood that each adhesive layer 107 and 111 can be provided with multiple release layers 119 and 121. For example, two or more release layers can be provided that individually partially cover different areas of the respective adhesive layer 107, 111 and collectively cover the entire surface of the adhesive layer 107 and 111. Advantageously, different areas of the adhesive layer 107, 111 can be exposed at different times, so that one or more operational steps can be performed on a portion of the ostomy body attachment 101 while protecting other portions until subsequent operational steps in the installation of the ostomy body attachment 101.

[0068] Referring to Figure 5 An ostomy body attachment 201 according to the present application is shown, which includes an adhesive wafer 202. Figure 5 The adhesive wafer 202 of the ostomy body attachment 201 of Figure 4 is the same as the adhesive wafer of Figure 5 therefore the same reference numerals (increased by 100) are used for the same features. Thus, Figure 5 The ostomy body attachment 201 of

[0069] The first release layer 219 is adhered to the pouch-facing side of the adhesive wafer 202. The first release layer 219 is shaped to cover the ostomy hole 205 and an inner region of the pouch-facing side of the adhesive wafer 202. Thus, in the present embodiment, the first release layer 219 has a substantially circular body that covers the entire ostomy hole 205 and an inner radial portion of the pouch-facing side of the adhesive wafer 202. A portion of the first release layer 219 projects radially outwardly from the body and beyond the outer boundary of the adhesive wafer 202 to form a tab 223 for grasping. A first image 227 in the form of the number "1" is printed on the tab 223 to indicate to the user the order in which to remove the first release layer 219 from the adhesive wafer 202.

[0070] The first release layer 219 also includes a second image 229 in the form of a company logo, for example Device Mark. In addition to identifying the brand of the ostomy body attachment 201, a second image 229 is provided to obscure the stoma hole 205 through the partially transparent first release layer 209 when viewed from the bag-facing side of the ostomy body attachment 201. Of course, the second image 229 can comprise any type of image or even a solid color block to obscure the stoma hole 205 and any underlying elements that can be visible through the stoma hole 205 when viewed from the bag-facing side of the ostomy body attachment 201.

[0071] A second release layer 221 is adhered to the skin-facing side of the adhesive pad 202. The second release layer 221 has a larger surface area than the adhesive pad 202 such that the second release layer 221 covers the entire skin-facing side of the adhesive pad 202 as well as the stoma hole 205 and extends beyond the adhesive pad 202. The second release layer 221 is substantially circular and also includes a tab 225 extending radially outward from the outer edge of the second release layer 221 so that the user of the ostomy body attachment 201 can grasp the second release layer 221.

[0072] A third image 231 in the form of the number "3" is printed on the tab 225 of the second release layer 221. As described above, this number is provided to indicate to the user of the ostomy body attachment 201 the sequence in which the second release layer 221 is removed from the adhesive pad 202 during an installation process that includes a plurality of sequential steps.

[0073] Referring to Figure 6 When the adhesive pad 202 and the second release layer 221 are properly arranged relative to one another, a fourth image 233 is printed on the second release layer 221 centered within the fourth image 223 in the stoma hole 205. In the present embodiment, the fourth image 233 includes the number "2", the text "roll up / turn up / flip up", and a plurality of arrows extending radially outward from the center of the second release layer 221 to indicate to the user of the ostomy body attachment 201 the direction in which to roll up the adhesive pad 202 and the sequence in which to do so.

[0074] As Figure 5As shown, the first release layer 219 has a degree of opacity for covering the fourth image 233 and at least partially obscuring it when viewed from the pouch-facing side of the ostomy body attachment 201. When the adhesive pad 202 and the first release layer 219 and the second release layer 221 are suitably arranged relative to one another, the presence of the centrally located second image 229 can further enhance the degree to which the fourth image 233 is obscured by the first release layer 219, the second image being located directly over the centre of the stomal hole 205. As previously mentioned, advantageously, by obscuring a portion of the ostomy body attachment 201 with another moveable portion of the ostomy body attachment 201, the time at which the user sees, or at least clearly sees, written instructions relating to the use of the ostomy body attachment 201 can be delayed, thus guiding the user through the correct sequence of operating steps.

[0075] Referring to Figure 7 , a fifth image 235 is printed on the second release layer 221 proximate to the edge 213 of the stomal hole 205. The position of the fifth image 235 is such that it is obscured by the adhesive pad 202 when viewed from the pouch-facing side of the ostomy body attachment 201 and when the ostomy body attachment 201 is in an unused state, thus the adhesive pad 202 is in an undeformed state, as shown in Figure 5 and Figure 6 . In the undeformed state, the position of the fifth image 235 proximate to the edge 213 of the stomal hole 205 is further such that it can be revealed when the user manipulates the adhesive pad 202 to a deformed second position, for example as shown in Figure 7 , at which time the diameter of the stomal hole 205 has increased, for example by rolling the adhesive pad 202 back on itself radially outwardly. In the present embodiment, the fifth image 235 comprises the numeral "3" and the text "remove this release liner", again indicating to the user the procedural steps and sequence to be taken. Preferably, the fifth image 235 is located within a maximum distance (for example 5mm) of the deformation of the stomal hole 205 from its initial state.

[0076] As mentioned above, by obscuring the fifth image 235 with another moveable portion of the ostomy body attachment 201, the revealing of the fifth image 235 to a user of the ostomy body attachment can be delayed. For example, where the fifth image 235 comprises a visual instruction relating to the use of the ostomy body attachment 201, the viewing of the fifth image 235, and thus the performance of the corresponding visual instruction, can be delayed until each preceding operating step has been completed. In this case, the operating step immediately preceding the operating step indicated by the fifth image 235 can involve moving a portion of the ostomy body attachment 201 which obscures or conceals the fifth image 236 to a second position in which the fifth image 238 is revealed to the user.

[0077] Referring to Figure 8A sixth image, 236, in the form of the number "4," is printed on the skin-facing surface of the stoma body accessory 201. In this embodiment, the sixth image 236 is printed on the skin-facing surface of the intermediate layer of the adhesive pad 202, beneath the skin-facing adhesive layer 207. Because the skin-facing adhesive layer 207 is translucent, the sixth image 236 is visible to the user when viewed from the skin-facing side of the stoma bag. The number depicted in the image instructs the user on the correct procedural steps for applying the adhesive pad 202 to the stoma patient's skin.

[0078] like Figures 5 to 7 As shown, a third release layer 237, in an arc shape, adheres to the pouch-facing side of the adhesive pad 202, surrounding and covering most of the outer circumferential area of ​​the pouch-facing side of the adhesive pad 202. The shape of the third release layer 237 is chosen to complement the shape of the first release layer 219, such that they together cover the entire pouch-facing side of the adhesive pad 202 and the stoma orifice 205. One end of the third release layer 237 extends beyond the outer boundary of the adhesive pad 202 to form a protrusion 239 for the user to grip. As shown, a seventh image 241 in the form of the number "5" is printed on the protrusion 239 to indicate to the user the order in which the third release layer 237 is removed when using the stoma body accessory 201.

[0079] like Figures 5 to 8 As shown, each of the first to seventh images 227, 229, 231, 233, 235, 236, and 241 is printed such that they are aligned in the correct direction when viewed from the bag-facing side of the stoma body attachment 201. Thus, for example, the number "3" or the text "roll up" is mirrored when viewed from the skin-facing side of the stoma body attachment 201. This helps guide the user of the stoma body attachment 201 to the correct side for performing the indicated steps, ensuring that the user rolls up the adhesive pad 202 in the correct direction and adheres the correct side of the adhesive pad 202 to the stoma patient's body.

[0080] It should be understood that, where space permits, any number of images can be applied to release layers 219, 221, 237 as needed to provide the user with visual instructions for the correct use of the stoma body accessory 201. It should also be understood that one or more images can be applied to the adhesive pad 202 itself, such as the base layer, to further supplement the instructions for use of the stoma body accessory 201. Therefore, one or more images can be provided on the adhesive pad 202, and one or more images can be provided on release layers 219, 221, 237, and each image can involve a series of instructions for the correct use of the stoma body accessory.

[0081] Each release layer 219, 221, 237 is made of a suitable material, such as silicone, to facilitate removal of the release layer 219, 221, 237 from the corresponding adhesive layer. Each release layer 219, 221, 237 is further made of or coated with a material that facilitates printing or drawing images on its surface.

[0082] While the above embodiments describe and depict a disc-shaped adhesive pad, it should be understood that the adhesive pad can have different shapes, such as square, star-shaped, rectangular, or elliptical, as long as one surface can define and enlarge an appropriately sized stoma opening, and sufficient surface area is required to ensure good contact with the ostomy patient's body. Furthermore, while the above embodiments describe and depict a substantially planar adhesive pad, it should be understood that part or all of the adhesive pad may include convex or concave contours. This may be ideal when used for ostomies with retracted stomas or stomas that are insufficient to protrude from the abdominal wall to extend through the stoma opening of a planar stoma body attachment. The protrusions or recesses of the stoma body attachment can be used to press against the abdominal wall of the ostomy patient and push the stoma into a more prominent position to capture the stoma opening. In this arrangement, the user clearly knows which side is more important to apply to the skin.

[0083] As described above, the stoma body accessory 201 is preferably installed according to a process comprising multiple consecutive steps. (See reference) Figure 5 and Figure 6 In the first step, the first release layer 219 is removed from the bag-facing side of the adhesive pad 202 to expose the stoma 205 and at least the inner area of ​​the bag-facing side of the adhesive pad 202 so that the user can access the edge 213 of the stoma 205. Figure 6 As shown, removing the first release layer 219 exposes the underlying fourth image 233 of the second release layer 221, which includes instructions for implementing the second step.

[0084] According to the second step shown, as Figure 6 and Figure 7 As shown, the user pushes the inner edge 213 of the stoma opening 205 upwards and outwards to roll the adhesive pad 202 itself along the bag-facing surface of the adhesive pad 202. This has the effect of forming a raised ring extending circumferentially around the stoma opening 205. The deformation and / or rolling action allows the user to increase the diameter of the stoma opening 205 to approximately correspond to the diameter of the target stoma 217. Figure 7 As shown, increasing the diameter of the stoma 205 helps to reveal the fifth image 235, thereby revealing visual instructions related to the next operational step in the installation sequence.

[0085] When the user has reached a stoma hole diameter corresponding to or slightly larger than the diameter of the target stoma 217 according to the visual indication of the fifth image 235, in a third step, the user removes the second release layer 221 from the skin-facing side of the adhesive wafer 202 to fully open the stoma hole 205, as shown in Figure 8 and Figure 9 .

[0086] Referring Figure 8 and Figure 10 , as shown in the sixth image 236 visible from the skin-facing side of the adhesive wafer 202, in a fourth step, the user adheres the adhesive wafer 202 to the skin of the ostomate with the stoma 217 extending through the stoma hole 205. The third release layer 237 provides a surface on which the user can exert pressure when adhering the adhesive wafer 202 to the ostomate without adversely affecting the pouch-facing adhesive layer of the adhesive wafer 202. As shown in Figure 10 and 11 , in a fifth step, the third release layer 237 is removed from the adhesive wafer 202 so that only the adhesive wafer 202 remains adhered to the body of the ostomate. In this position, the adhesive wafer 202 encircles the stoma 217 and the loop formed in the previous steps extends upwards along the outer wall of the stoma 217 away from the body of the ostomate. Due to the degree of memory of the base layer, the adhesive wafer 202 springs back so that the diameter of the stoma hole 205 is reduced and the loop encircles the stoma 217 in a snug manner.

[0087] Referring Figure 12 , in a fifth step which is also the last step, the user adheres the ostomy pouch 243 to the adhesive wafer 202 to form the ostomy appliance 245. Thus, a seal is formed between the ostomy appliance 245 and the stoma 217 so that waste is discharged from the stoma 217 into the pouch 243 without leakage.

[0088] As shown in Figure 13 and Figure 14 , an ostomy body attachment 301 according to the present application can be housed within a sealed case 347. The ostomy body attachment 301 can be substantially identical to the ostomy body attachment 201 described above. The sealed case 347 can comprise a case base 349 made of a plastic material shaped to receive and support the ostomy body attachment 301 in a substantially horizontal position. A foil inner liner 351 is provided extending across the open face of the case base 349 to seal the ostomy body attachment 301 within the case base 349. Thus, in order to access the ostomy body attachment 301, the user can remove the foil inner liner 351 from the case base 349. The case 347 provides a protective sealed environment for the ostomy body attachment 301 for the transportation, storage and sale of the ostomy body attachment 301.

[0089] Figures 15 to 17 An alternative embodiment of the invention is shown, which has the first embodiment of the invention ( Figures 5-12 Many features of ). Therefore, this description focuses on the differences and uses the same numbering system (incrementing by 1000).

[0090] The first major difference in the second embodiment lies in the translucency of the first release layer 1219 and the printing thereon. Specifically, the first release layer 1219 of the first embodiment has sufficient opacity to partially conceal the printed fourth image 233, and further partially conceals it through the second image 229 provided thereon. On the other hand, the material of the first release layer 1219 in this embodiment has no image and is completely blank in the area covering the stoma 1229. However, its translucency allows only the adhesive pad 1202 to be seen through the first release layer, as it contacts the first release layer 1219. The image 1233 on the second layer 1221 is completely hidden because the air gap between it and the first release layer 1219 is equal to the thickness of the adhesive pad 1202 (i.e., approximately 1 mm to 2 mm).

[0091] The second major difference in the second embodiment again relates to the lack of features. In this embodiment, unlike the third embodiment, the roll-up adhesive pad 1202 does not reveal a further image 235, but rather a blank 1235 exists in the area near the raised ring formed by the inner edge of the roll-up adhesive pad. Therefore, in this embodiment, the user must rely on a third image 1231 printed with the number "3" on the tabs 1225 of the second release layer 1221 to indicate that they should remove the second release liner 1225 after the ring is formed.

[0092] Therefore, although the first embodiment has two portions that can move between a first position and a second position in an unused state, and in the second position, when viewed from the second side of the adhesive pad, the image is at least partially exposed through the stoma hole (i.e., the rollable portion of the first release liner 219 and the adhesive pad 202), in the second embodiment, only one portion can move between the first position and the second position in an unused state, and in the second position, when viewed from the second side of the adhesive pad, i.e., the first layer 1219, the image is at least partially exposed through the stoma hole, which can move from a first (unused) position where the image 1221 is completely hidden to a second position where the image 1221 is visible (when it is removed).

[0093] Of course, as mentioned above, the second embodiment is used in exactly the same way as the first embodiment.

[0094] The above description of one or more embodiments is by way of example only. Many variations are possible without departing from the scope of protection provided by the appended claims.

Claims

1. An ostomy body accessory for forming a seal between an ostomy instrument and an ostomy patient, the ostomy body accessory comprising an adhesive pad and a first removable release layer adhered to a first side of the adhesive pad, the adhesive pad including an ostomy opening formed through the adhesive pad, wherein the first removable release layer includes an image located on its surface, wherein, In the unused state, when viewed from the second side of the adhesive pad opposite the first side, the image is at least partially hidden by a portion of the stoma body accessory, and wherein the portion is movable between a first position and a second position in the unused state, in the second position, when viewed from the second side of the adhesive pad, the image is at least partially revealed through the stoma hole.

2. The stoma body accessory according to claim 1, wherein, The portion of the image that is at least partially hidden when the stoma body accessory is not in use includes a portion of the adhesive pad.

3. The stoma body accessory according to claim 2, wherein, The adhesive pad is deformable to the second position, in which the size of the stoma hole increases, and wherein the adhesive pad and the first removable release layer are arranged opposite each other such that when in an unused state, the image is close to the edge of the stoma hole, thereby revealing the image when the portion of the adhesive pad is deformed to the second position.

4. The stoma body accessory according to claim 3, wherein, The image is located on a region of the surface of the first removable release layer, the region being located between the boundary of the stoma in its unexpanded state and the boundary of the stoma in its fully expanded state.

5. The stoma body accessory according to any one of claims 2 to 4, wherein, The portion of the adhesive pad is rollable.

6. The stoma body accessory according to claim 5, wherein, The image is located on a region of the surface of the first removable release layer, the region being within the boundary of the stoma opening defined by the adhesive pad in its maximum roll-up state.

7. The stoma body accessory according to claim 3 or 4, wherein, The image is located within 10 mm of the edge of the stoma at the first location on the surface of the first removable release layer.

8. The stoma body accessory according to any one of claims 3 to 7, wherein, The image bends along the edge of the stoma, such that the image extends at least partially around the stoma.

9. The stoma body accessory of claim 1, further comprising a second removable release layer accessible from a second side of the adhesive pad; wherein, The portion of the image that is at least partially hidden when not in use includes a second removable release layer.

10. The stoma body accessory according to claim 9, wherein, The first removable release layer and the second removable release layer are arranged opposite each other such that when the second removable release layer is removed from the rest of the stoma body attachment, the image is at least partially exposed.

11. The stoma body accessory according to claim 9 or 10, wherein, The second removable release layer is semi-transparent.

12. The stoma body accessory according to claim 11, wherein, The translucency of the second removable release layer makes features separated from the second removable release layer by more than 1 mm invisible through the second removable release layer.

13. The stoma body accessory according to claim 12, wherein, The first removable release layer is separated from the second removable release layer by at least 1 mm, such that there is a gap of at least 1 mm between the first removable release layer and the second removable release layer in the region of the stoma, thereby hiding the image in the unused state, because the translucency of the second removable release layer makes the feature structures on the first removable release layer invisible through the second removable release layer due to the gap in the region of the stoma.

14. The stoma body accessory according to claim 9 or 10, wherein the second removable release layer is opaque.

15. The stoma body accessory according to any one of claims 2 to 8, further comprising a second removable release layer accessible from a second side of the adhesive pad, wherein, The first removable release layer includes another image that is at least partially hidden by the second removable release layer when not in use, and wherein the first removable release layer and the second removable release layer are arranged opposite each other such that when the second removable release layer is removed from the remainder of the stoma body attachment, the other image is at least partially exposed.

16. The stoma body accessory according to any one of claims 9 to 15, wherein, The second removable release layer includes one or more of numbers, letters, graphic representations and patterns on its surface, and is arranged to at least partially conceal the image and / or the other image when not in use.

17. The stoma body accessory according to any one of the preceding claims, wherein, The image relates to operational steps in the use of the stoma body accessory, and wherein the first removable release layer is arranged relative to the portion such that the image is at least partially exposed after one or more prior operational steps in the use of the stoma body accessory are completed, the one or more prior operational steps causing the portion to move from the first position to the second position.

18. The stoma body accessory according to any one of the preceding claims, wherein, The image includes one or more of numbers, letters, graphic representations, and patterns.

19. The stoma body accessory according to any one of the preceding claims, wherein, The image includes text that appears to move forward when viewed from the second side of the adhesive pad.

20. The stoma body accessory according to any one of the preceding claims, wherein, The stoma opening is circular when not in use.

21. The stoma body accessory according to any one of the preceding claims, wherein, The ostomy opening is formed through the center of the adhesive pad.

22. The stoma body accessory according to any one of the preceding claims, wherein, The adhesive pad is disc-shaped.

23. The stoma body accessory according to any one of the preceding claims, wherein, The adhesive pad is substantially planar.

24. The stoma body accessory according to any one of claims 1 to 22, wherein, The adhesive pad has a convex profile.

25. The stoma body accessory according to any one of the preceding claims, wherein, The portion of the image that is at least partially hidden when the ostomy body accessory is not in use is the portion that is completely hidden when the ostomy body accessory is not in use.

26. An ostomy apparatus comprising an ostomy body accessory according to any one of claims 1 to 25.

27. A method for manufacturing an ostomy body accessory, comprising the following steps: An adhesive pad defining a stoma opening is formed, an image is applied to a release layer, and the release layer is adhered to a first side of the adhesive pad such that, when viewed from a second side of the adhesive pad opposite the first side, in an unused state, the image is at least partially hidden by a movable portion of the stoma body accessory, wherein the movable portion is movable between a first position and a second position in an unused state, in which, when viewed from the second side of the adhesive pad, the image is at least partially revealed through the stoma opening.

Images