OSTOMY APLLIANCE

Abstract: A series of sequentially peelable adhesive members are provided for attaching an ostomy bag to a body-attachable pad. The series is attachable to a pad of medical grade adhesive. Each said adhesive member has a grasping tab, the tabs being arranged so that peeling off one tab exposes a following tab, the latter tab not being accessible to the user until the said one tab has been peeled off. An ostomy appliance comprising a bag for receiving discharged wastes, a stomal orifice in one wall of the bag. The medical grade adhesive pad carries a flange having an inner peripheral rib having a tapered annular outer surface at the end thereof.

Description: This invention relates to an ostomy appliance; and to a series of sequentially peelable adhesive members for attaching an ostomy bag to a body-attachable pad. In a successful known system, described and illustrated in British Patent No. 1 571 657, an ostomy bag is attached to a skin-compatible medical grade adhesive pad by a releasable coupling. In the case of some ostomates, however, it may be desirable to provide a lightweight, simple adhesive attachment system. A composite sealing ring is disclosed in British Patent No. A-1 256 866. This ring is attached to the body of a wearer. An ostomy bag is attached to the ring by a ring of material which has adhesive on both faces. According to the present invention, there is provided a series of sequentially peelable adhesive members for attaching an ostomy bag to a body-attachable pad, the said series being attachable to a pad of medical grade adhesive serving as the body-attachable pad, each said adhesive member having a grasping tab, the tabs being arranged so that peeling off one tab exposes a following tab, the latter tab not being accessible to the user until the said one tab has been peeled off. According to an embodiment of the invention there is provided an ostomy appliance in combination with a series of adhesive members, the appliance comprising a bag for receiving discharged wastes, a stomal orifice in one wall of the bag, a medical grade adhesive pad carrying a flange and having a stomal aperture therein, there being adhesive means for adhesively attaching the bag to the flange, said flange being characterised by an inner peripheral rib having a tapered annular outer surface at the end thereof. The peelable adhesive members are intended for sequential use in attaching the bag, via its flange, to a pad of medical grade adhesive material which the wearer has attached to his (or her) skin at the peristomal region. The reason for having a plurality of adhesive layers separated by peelable cover annuli is so that a new double sided annulus can be exposed by peeling off the outer cover layer. Hence each time a bag is emptied or changed it can be securely reattached to the medical grade adhesive pad and there is no need to frequently remove the pad. This is a considerable advantage in that the operation of removing and replacing such a pad is one of some difficulty and is often painful. This application is divided out of European Patent No. 146,367 B to which the reader is referred. The invention will be better understood from the following non-limiting description of examples thereof given with reference to the accompanying diagrammatic drawings in which:- Figures 1 and 2 show, in cross-section and in front elevation respectively, one embodiment of a skin-compatible medical grade adhesive pad carrying a plurality of sequentially peelable "peel off" adhesive annuli; Figures 3 and 4 show, in cross-section and in front elevation respectively, a second embodiment of a pad carrying a different arrangement of "peel off" adhesive annuli; Figures 5 and 6 show, in cross-section and in front elevation respectively, a pad carrying yet another arrangement of "peel off" adhesive annuli; Figure 7 diagrammatically shows a further embodiment of a body-attachable pad together with an ostomy bag; Figures 8, 9 and 10 illustrate a tapered or angled rib feature of one embodiment of the present invention, Figure 8 being a front view, Figure 9 a vertical axial cross-section, and Figure 10 being an enlargement of part of Figure 9; Figures 11 and 12 are front view and vertical axial cross-sections of an embodiment of the invention wherein a marginal portion of the bag wall surrounding the stomal aperture acts as a wiper to wipe the peripheral rib of the body-attachable flange. Figures 13 and 14 are like views respectively of a washer or flange for attachment to an ostomy bag to render it highly suitable for use as a peel-off bag; Figure 15 is an enlargement for clarity of part of Figure 14; and Figures 16 and 17 are a front view and a vertical axial cross-section, respectively, of an ostomy appliance and bag illustrating a stack of peelable adhesive members and a tapered rim on a peripheral rib of the body side flange. In the drawings, like parts bear like reference numerals. Referring firstly to Figures 16 and 17, the illustrated ostomy appliance includes a medical grade adhesive pad 2724 and an ostomy bag 2722. The ostomy bag has a stomal orifice which is surrounded by a flange, e.g. of synthetic plastics material, having an annular flat surface which is intended to face towards the body of the wearer when the appliance is in use. The medical grade adhesive pad 10 also has secured thereto a flange 2720 which optionally includes an inner peripheral rib. The flange 2720 has an outwardly facing flat annular surface, intended to receive a stack of sequentially peelable adhesive annuli. The medical grade adhesive pad 2724 may be bonded to a plastics film layer, in conventional manner. In use, a hole is cut in the pad and the film so that the user's stoma can be passed therethrough. Suitable medical grade adhesives comprise pressure sensitive adhesive formulations that consist of a homogeneous blend of one or more water soluble or water swellable hydrocolloids dispersed in a viscous elastomeric substance such as polyisobutylene as disclosed by Chen in United States Patent 3,339,506. Optionally, the adhesive composition can also include one or more cohesive strengthening agents described by Chen et al in U.S. Patent 4,192,785 or one or more hydratable natural or synthetic polymers as described by Pawelchak et al in U.S. Patent 4,393,080. Other medical grade adhesives designed for ostomates and available on the market are also suitable. The bag 2722 may be either a bag having a drain outlet, or may alternatively be a closed bag intended to be thrown away when full. The words "annulus" and "annuli" are used in the application without a strict geometrical meaning. That is to say, a double sided annulus as used in this invention need not be geometrically circular; an adhesive layer of any shape which surrounds the stomal orifice and which can be peeled off from an adjacent layer to expose a region of adhesive would be suitable. As seen in Figures 1 and 2, a pad 70 of skin-compatible medical grade adhesive material such as that described above, and carrying a strippable rear cover layer 72 supports a front cover sheet 74 whose function is to cover over the edges 76 of the pad 70 which would otherwise be exposed, there being a strippable annular paper or like layer 78 which protects adhesive on the rear surface (left hand side as seen in FIG. 1) of the protective layer 74 where this extends beyond the pad 70. As illustrated, the pad 70 is in the form of a flat disc and the protective layer 74 is substantially rectangular. Attached to the pad 70 is a plastics disc 82 carrying a central circular rim 84 which defines a stomal aperture 86. The disc 82 carries, stacked over the layer 74, a stacked pile of annular adhesive attachment members, herein called plasters, each plaster being constituted by a layer of tough paper or flexible plastics film bearing adhesive 85 and having a grippable tab 92. The tab arrangement as illustrated in FIG. 2 is such that the rearmost plaster has the largest tab and the forwardmost plaster has a relatively small tab as seen at 94. The assembly is protected by a front cover annular layer of release paper or other suitable material which is identified at 98. It will be seen that by peeling off firstly the cover layer, an annular region of adhesive is exposed to which an ostomy bag may be applied, and after that bag has been filled, then by peeling off the first adhesive plaster 94 further fresh adhesive on the so-exposed face of the next underlying plaster is made available for attaching a subsequent ostomy bag to the appliance. FIGS. 3 and 4 show an alternative version of this embodiment of the invention, the difference being that in this embodiment the tabs of the adhesive plasters 100 are all of the same size. As seen in FIGS. 3 and 4, no adhesive is provided between the plasters outside the annular region, so that one tab can readily be separated from the next and so that the cover sheet 102 can be removed at the beginning of the use of the appliance. Another variation of this embodiment of the invention is illustrated in FIGS. 5 and 6. According to this advantageous version, each of the cover layers 106 and the plasters 108 is annular in form with an upwardly projecting tab, the tab being denoted 110 in the case of the cover layer and 112 for each of the plasters. Each of the plasters has a tab of progressively increasing height, moving from the plaster closest to the disc 82 to the plaster furthest from the disc 82. Moreover, each tab has an elongated slot cut therein, near to the top of the tab, to enable a user to insert his fingernail in the slots so as to more readily separate one tab from the next. The slot in the cover layer is indicated at 114 and the aperture in the front tab 112 is indicated at 116. For simplicity of illustration in FIG. 6, the other apertures in the tabs 108 are not shown. Referring to the versions of the invention shown in FIGS. 1-6, it will be realized that any convenient numbers of separate plasters may be employed. Although five plasters have been illustrated in FIG. 1, and four plasters in FIGS. 3 and 5, any selected number of plasters, e.g. one for each day of the week, can be included in the appliance. Moreover, while in some instances it may be preferable for the ostomy bag which is to be used with the illustrated appliances to have a relatively stiff plastics flange surrounding the stomal orifice in one of its walls, in other instances no such stiff flange would be needed and the bag wall could be adhesively secured directly to the exposed adhesive surface. An alternative embodiment of the invention is shown in FIG. 7, which is a diagrammatic cross-section illustrating the skin 120 of a wearer with a body-attachable pad 122 of medical grade adhesive material such as that referred to above. The stoma of the patient is seen at 124, projecting through a suitable hole in the pad 122. A disc 126 carrying a circular rim 128 is connected to the pad 122 by a flexible annular sheet 130. The sheet 130 may be of fabric or of a thin flexible plastics film. The disc 126 carries a stack of annular plasters 132, each of which has a tab 134. A strippable protective front cover layer 136 protects the adhesive 138 on the outermost plaster. An ostomy bag 140 having a stomal aperture 142 surrounded by a flat thin plate of annular form 144 cooperates with the body-attachable appliance including the pad 122. In use, the protective layer 134 is stripped off exposing the adhesive layer 138 and the bag is brought in face to face manner up against this adhesive, the rim 128 then extending just within the confines of the stomal orifice 142. The bag is consequently held firmly in position on the disc 126 and during the assembly, the user can if he wishes place his fingers behind the disc 126 to support the disc 126 against the pressure needed to press the plate 144 onto the adhesive 138. When the bag 140 is full, it is removed, the used plaster is also removed so exposing a fresh adhesive surface on the plaster beneath. A new bag can then be applied in a similar way. FIGS. 8-10 illustrate an alternative design of a flange member for attachment to a medical grade adhesive pad. This flange member 1920, like the flange member 2720 of FIG. 17, has an inner peripheral rib 1922. In order to provide a "lead-in" when a user is attaching a bag to an exposed adhesive surface of one of the peelable adhesive members, the inner end, that is to say the end of the rib which extends towards the ostomy bag when the ostomy bag is being applied and which extends into the ostomy bag when it is secured, it canted inwardly as seen best in FIG. 10. at 1923. Consequently, a tapered annular outer surface 1925 is provided which assists a wearer of a bag in bringing the stomal orifice of the bag properly into registry with the flange member 1920. In another embodiment of the invention, there are provided seven peelable adhesive members which may for example be numbered 1-7, and may be arranged in the manner illustrated in FIG. 11. Referring to FIGS. 12 and 13, a medical adhesive pad is shown at 2310, the flange thereon at 2320, and a layer of self adhesive fabric 2321 is placed over the flange 2320 beneath the base of the stack of peelable adhesive members 2323. A flat annular plastics washer 2325 is secured to a wall 2327 of an ostomy bag whose other wall is seen at 2329. The flat annular washer 2325 may be of plastics material and is constructed so that it has a central circular orifice whose diameter is somewhat greater than the outside diameter of the substantially cylindrical rib wall 2322. The material of the bag wall 2327 however extends inwardly of the inner edge of the washer 2325, and in use acts to wipe against the outside wall of the rib 2322 so tending to keep this outside wall clean of waste materials. It will be appreciated that because the diameter of the stomal orifice in the washer 2325 is greater than the outside diameter of the rib wall 2322, applying the bag to the flange does not require a careful and "fiddy" adjustment of relative positions. Instead of utilizing a plain, flat annular washer such as 2325 shown in FIG. 12, one may instead emply a washer for attachment to an ostomy bag of the form shown in FIGS. 13 and 14. This washer may for example be of ethylene vinyl acetate polymer and, referring to FIGS. 13-15 , is attached to an ostomy bag surrounding the stomal aperture thereof, the bag being show at 2510. The washer 2512 has one annular flat surface 2514 intended for presentation to the exposed adhesive of one of the peelable adhesive members. There is a beading 2516 at the outer rim of the washer 2512. The inner margin of the stomal aperture 2518 in the washer 2512 is formed by a flexible deflectable seal strip 2520 forming part of the washer 2512. This seal strip 2520 serves a similar function to the inner portion 2331 of the bag wall 2327 in that it assists in wiping waste material clear of the cylindrical rib portion of a flange such as flange 2320. Equally, it would act similarly in relation to the external cylindrical surface of the rib 1922 illustrated in FIG. 9. FIGS. 16 and 17 illustrate a flange 2720 which is substantially in accordance with the design illustrated in FIGS. 19-21 assembled in conjuction with an ostomy bag 2722 and a medical grade adhesive pad 2724. The bag 2722 is of course not shown in FIG. 16, and the arrangement of peelable adhesive members is similar in broad concept to that illustrated in FIG. 12 of the present patent application. While there have been suggestions in the past, e.g. in British Patent Specification No. 1 256 866, that an ostomy bag can be attached to a body-attachable ring by adhesive, there has been (to the best of Applicants' knowledge and belief) no means hitherto suggested or obtainable other than recent patent applications of the present Applicant whereby a series of ostomy bags can be adhesively attached in turn to a single body-attachable member, while the member remains attached to the body of the wearer. The reader is referred to our European Patent No. EP-B-146367 in this connection. Moreover, the arrangement according to the invention is light in weight, has a very flat configuration, does not produce an unsightly buldge under the clothes, and is easily and inexpensively manufactured.

Claims: A series of sequentially peelable adhesive members (32) for attaching an ostomy bag (12) to a body-attachable pad (10), the said series being attachable to a pad of medical grade adhesive serving as the body-attachable pad, each said adhesive member having a grasping tab (36), the tabs being arranged so that peeling off one tab exposes a following tab, the latter tab not being accessible to the user until the said one tab has been peeled off. An ostomy appliance in combination with a series of adhesive members according to claim 1, the appliance comprising a bag for receiving discharged wastes, a stomal orifice in one wall of the bag, a medical grade adhesive pad carrying a flange (1920) and having a stomal aperture therein, there being adhesive means for adhesively attaching the bag to the flange, said flange being characterised by an inner peripheral rib (1922) having a tapered annular outer surface (1925) at the end thereof.

Inventors: STEER, PETER LESLIE
Applicants: E.R. SQUIBB & SONS, INC.
Application year: 1984
Main classification: A61F5
IPC codes: A61F5, A61N5