OSTOMY APPLIANCE

Abstract: An ostomy appliance includes a bag for receiving discharged wastes. There is a stomal orifice (2518) in one wall of the bag and a washer (2512) attached to the wall of the bag and having a flat surface (2514) intended to face towards the body of the wearer when the appliance is worn, surrounding said orifice. A medical grade adhesive pad carries a flange and has an inner peripheral rib (2522). Adhesive means (2323) is used for adhesively attaching said bag to said flange. The washer (2512) further comprises a flexible seal strip (2520) at the inner margin of said washer surrounding said stomal orifice.

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 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 in that said washer further comprises a flexible seal strip at the inner margin of said washer surrounding said stomal orifice capable in use of wiping waste material from the outside of the inner peripheral rib. A flexible microporous layer or tape may be used to assist in attaching the medical grade adhesive pad to the skin of the wearer. In an arrangement having a body-attachable pad carrying a flange to which is adhesively secured a stack of sequentially peelable adhesive members for attaching an ostomy bag to the flange, the flange and the pad may be connected by a flexible web which permits limited relative movement therebetween in a direction substantially perpendicular to the pad. Using such an arrangement, an ostomate can place his/her fingers behind the flange (i.e. between the flange and his body) so as to absorb the pressure which is applied to fix the bag to the exposed one of the stack of plasters. The invention will be better understood from the following non-limiting description of examples thereof given with reference to the accompanying drawings in which:- Figure 1 is an exploded view illustrating an adhesive plaster; Figure 2 is a cross-section taken in a vertical plane through the adhesive plaster shown in Figure 1 with the thickness exaggerated for clarity of illustration; Figures 3 and 4 are front views and vertical axial cross sections respectively of a washer or flange according to the present invention for attachment to an ostomy bag to render it highly suitable for use as a peel-off bag; and Figure 5 is an enlargement for clarity of part of Figure 4. Referring firstly to Figures 1-5, the illustrated ostomy appliance includes a medical grade adhesive pad 218 and an ostomy bag 2510. The ostomy bag has a stomal orifice 2518 which is surrounded by a flange 2514, 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 also has secured thereto a flange. 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 may be either a bag having a drain outlet or may alternatively be a closed bag intended to be thrown away when full. The illustrated adhesive plaster 210 (Figs. 1 and 2) includes a substrate 212 (which may for example be a conventional fabric substrate as found in conventional sticking plasters) having a central hole 214 therein to constitute a stomal aperture. The rear (body side) surface of the substrate carries adhesive 216 whereby the plaster can be fixed to a body-attachable member 218, not shown in Figure 2. The front (or bag side) surface carries adhesive 220 which is covered by a peelable protective layer 222. The layer 222 is divided into five annular regions 222a to 222e by circular partial cuts 224 which extend through, for example, about three quarters of the thickness of the protective layer 222. These cuts may be made by a punching or stamping operation. Alternatively, the cuts may extend completely through the layer 222, or lines of weakening may be produced by having rows of perforations. Other expedients will occur to a man of average skill in the art. While a circular hole 214 and circular cuts 224 have been described, it will be appreciated that a non-circular, e.g. oval, configuration could be employed although circular is preferred. In use of the assembled appliance, an intervening member 230 herein called a chute member is fixed to a body-attachable pad 218 of medical grade adhesive and the cylindrical wall 230a of the chute is passed through the hole 214, the latter being of a sufficient size to accommodate the chute. The chute functions to guide any waste products issuing from the stoma into the interior of an ostomy bag and to minimize the chance of any of them coming into contact with the adhesive 216 or the adhesive 220. If such contact were to occur, the security of attachment provided by the adhesive would be made less reliable. However, in some instances, e.g. when a very simple and inexpensive ostomy system is desired, the chute 230 can be omitted and the plaster 10 attached directly by the adhesive 216 to the pad 218. In use, the inner ring 222a is peeled or stripped off, so exposing an annular area of adhesive 220, and the wall of an ostomy bag having a stomal orifice therein is brought in face to face contact with the exposed area of adhesive 220, with the stomal orifice in the bag wall substantially in registry with the hole 214. To facilitate stripping off the rings 222a to 222e, each ring may carry a tab or projection which can be grasped between finger and thumb. The tabs may if desired be numbered as shown in Figure 1. The ostomy bag employed may be of the kind which has a flat annular flange on its rear wall surrounding the stomal orifice therein, or such a flange may be omitted and the bag rear wall directly applied to the adhesive 220. The intermediate member 230 may advantageously be made by vaccum forming a synthetic plastics film, and its flange 230b is preferably ultrasonically welded to a plastics film forming the outer surface boundary of the pad 218. In an advantageous embodiment of the invention, the adhesive 216 may be such as to have a higher "peel strength" than the adhesive 220. This ensures that the attachment of the plaster 210 to the pad 18 remains secure when force is applied to peel off one of the rings 222a to 222e. A washer or flange may be employed for attachment to an ostomy bag of the form shown in Figures 3 to 5. This washer or flange 2512 may for example be of ethylene vinyl acetate polymer and is attached to an ostomy bag surrounding the stomal aperture thereof, the bag being shown at 2510. The washer or flange 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 deflectible seal strip 2520 forming part of the washer 2512. This seal strip 2520 assists in wiping waste material clear of the cylindrical rib portion of a flange such as flange 230. 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. In this connection, the reader is referred to our European Patent No. (EP-B)146367. Moreover, the arrangement according to the invention is light in weight, has a very flat configuration, does not produce an unsightly bulge under the clothes, and is easily and inexpensively manufactured.

Claims: An ostomy appliance comprising a bag (2510) for receiving discharged wastes, a stomal orifice (2518) in one wall of the bag, a washer (2512) attached to the wall of the bag, surrounding said orifice, and having a flat surface (2514) intended to face towards the body , of the wearer when the appliance is worn, a medical grade adhesive pad (218) carrying a flange (230) having an inner peripheral rib (230a), and adhesive means (210;) for adhesively attaching said bag to said flange, characterised in that said washer (2512) further comprises a flexible seal strip (2520) at the inner margin of said washer surrounding said stomal orifice capable in use of wiping waste material from the outside of the inner peripheral rib (230a).. An appliance according to claim 1 in which the adhesive means comprises an adhesive layer (220) covered by a peelable protective layer divided into annular regions (222a to 222e) by partial cuts, whereby the annular regions can be peeled off sequentially in use. An appliance according to claim 1 or 2 in which the adhesive means comprises a plurality of peelable annular members (232) each having a layer of adhesive on one side thereof and a peripherally projecting portion (Fig. 22) for grasping by a user when it is desired to peel off one annular member. An appliance according to claim 3 in which the peripherally projecting portions of adjacent members are angularly spaced apart from one another. An appliance according to claim 1, 2, 3 or 4 in which a layer of self-adhesive fabric (212) overlies a flange (230b) located at the base of a stack of peelable adhesive members constituting the adhesive means.

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