OSTOMY APPLIANCE

Abstract: An ostomy appliance comprises a bag for receiving discharged wastes, a stomal orifice in one wall of the bag, a washer (2325) attached to the wall of the bag and having a flat surface intended to face towards the body of the wearer when the appliance is worn. The washer surrounds the orifice. A medical grade adhesive pad (2310) carries a flange (2320) having an inner peripheral rib (2322), and adhesive means (2323) adhesively attaches the bag to the flange. The bag wall (2327) extends inwardly of the inner edge of said washer surrounding said stomal orifice. In use, the outside wall of the rib tends to be kept clean of waste materials by said inner extending bag wall (2331).

Description: This invention relates to an ostomy appliance. In a successful known ostomy 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 post-surgical drainage appliance is disclosed in British Patent (GB-A) No. 1,256,866. This application has a sealing ring which comprises an inner and an outer ring. The inner ring is formed of a gelatinous material, such as a mixture of karaya powder and glycerol, and the outer ring is located concentrically about the inner ring and attached thereto, the outer ring being formed of a cellular synthetic plastics material. A backing ring is adhesively attached to the sealing ring. According to the present invention, there is provided an ostomy appliance comprising a bag for receiving discharged wastes, a stomal orifice in one wall of the bag, a washer attached to the wall of the bag and surrounding said orifice and having a flat surface intended to face towards the body of the wearer when the appliance is worn, a medical grade adhesive pad carrying a flange having an inner peripheral rib, and adhesive means for adhesively attaching said bag to said flange, characterised by said washer being so constructed that it has a central orifice whose diameter is somewhat greater than the outside diameter of the rib wall, and by said bag wall extending inwardly of the inner edge of said washer and wiping against the outside wall of the rib so tending to keep the outside wall of the rib clean of waste materials. According to one embodiment of the invention, the said adhesive comprises a plurality of peelable annular members having an adhesive layer on at least one side thereof and carried by said pad. Such an appliance may include a plurality of double sided adhesive annuli, separated by peelable cover annuli carried by the pad, each of the double sided adhesive annuli having a peripherally projecting portion. The double-sided adhesive annuli 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. Such an appliance can be used as a 4-day bag or a 5-day bag by providing a corresponding number of double sided adhesive annuli. Each cover layer may have a radially projecting finger tab which serves two purposes, firstly it can carry a number or indication (e.g. "Monday") and secondly it enables the cover layer to be readily stripped off to expose the adhesive surface of the underlying double sided adhesive layer so that the flat surface of the flange on the bag can be brought into face-to-face contact with the so exposed adhesive surface. In accordance with one preferred embodiment of the invention, such an appliance may include a layer of self adhesive fabric placed between said flange and said plurality of peelable annular members. A flexible microporous layer or tape may be used to assist in attaching the pad to the skin of the wearer. In one embodiment the tabs are arranged so that peeling off a first tab exposes a second tab, the latter not being accessible to the user until the first tab has been peeled off. In another embodiment the tabs are radially extending and angularly spaced apart from tabs of adjacent adhesive numbers. Alternatively, double sided adhesive layers may be alternated with peelable cover layers, and the cover layers may be shaped and arranged so that they are sequentially peelable, that is to say, each cover layer has a grasping tab and these tabs are so arranged that peeling off one tab exposes an underlying tab. Each cover layer is peeled off when it is desired to expose a fresh region of adhesive in order to attach a clean bag to the pad of skin-compatible material which is adhesively attached to the peristomal region. The invention will be better understood from the following non-limiting description of an example thereof given with reference to the accompanying diagrammatic drawings in which: Figures 1 and 2 are front view and vertical axial cross-sections illustrating the present 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. In the drawings, like parts bear like reference numerals. Referring to Figures 1 and 2, the illustrated ostomy appliance includes a medical grade adhesive pad 2310 and an ostomy bag 2327, 2329. The ostomy bag has a stomal orifice which is surrounded by a flange or washer 2325, 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 2310 also has secured thereto a flange 2320 which optionally includes an inner peripheral rib 2322. The flange 2320 has an outwardly facing flat annular surface, intended to receive a stack of adhesive annuli 2323 which are interleaved with annular cover layers. The medical grade adhesive pad 2310 may be bonded to a plastics film layer in conventional manner. 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 adhesive annuli are indicated at 2323, and for example, seven are here shown. This would be appropriate for a 7-day ostomy appliance. The seventh one in order of use is directly adhesively attached by one of its adhesive surfaces to a self-adhesive fabric 2321 and by its other surface to a peelable annular cover layer. Like cover layers are located between adjacent adhesive annuli, and these cover layers as seen best in Figure 1 each have a radially projecting finger tab useful firstly for peeling off the cover layer and secondly for carrying a numeral or other visible indication to assist the user of the appliance. The bag 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, an 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. The layer of self adhesive fabric 2321 is placed over the flange 2320 beneath the base of the stack of peelable adhesive members 2323. The flange or plastics washer 2325 is flat, annular, and of plastics material and is secured to the wall 2327 of the 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. 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 Applicant's 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 attention of the reader is drawn to our European Patent No. B-146367.

Claims: An ostomy appliance comprising a bag (2329) for receiving discharged wastes, a stomal orifice in one wall of the bag, a washer (2325) attached to the wall of the bag and surrounding said orifice and having a flat surface intended to face towards the body of the wearer when the appliance is worn, a medical grade adhesive pad (2310) carrying a flange (2320) having an inner peripheral rib (2322), and adhesive means (2323) for adhesively attaching said bag to said flange, characterised by said washer (2325) being so constructed that it has a central orifice whose diameter is somewhat greater than the outside diameter of the rib wall (2322), and by said bag wall (2327) extending inwardly of the inner edge of said washer (2325) and wiping against the outside wall of the rib (2322) so tending to keep the outside wall of the rib (2322) clean of waste materials. An appliance according to claim 1 wherein said adhesive means (2323) comprises a plurality of peelable annular members having an adhesive layer on at least one side thereof and carried by said pad. An appliance according to claim 2 wherein said plurality of peelable annular members comprises at least seven members. An appliance according to claim 2 or 3 wherein said appliance further comprises: a layer (2321) of self adhesive fabric placed between said flange (2320) and said plurality of peelable annular members. An appliance according to claim 2, 3, or 4 in which each peelable member has a radially-projecting tab. An appliance according to claim 5 in which each said tab carries a letter or a numeral.

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