GB2296662A - Two piece ostomy coupling - Google Patents

Abstract

A two-piece coupling for joining a pad or dressing to an ostomy bag. The first member 10 has a formation defining two opposing walls 11, 12. A second member 20 of closed loop form defines a stomal aperture. The second member 20 has an annular first rib 23 which can be positioned between the two walls, and from which extends a flexible annular seal element 24 dimensioned and positioned to resiliently bear against one 11 of the walls, when the members are connected. The rib 23 makes sealing engagement with said one wall. The base of the first rib is integral with or secured to a radially extending flange. The second member 20 has an annular second rib 26 which faces towards the first member and extends into a complementary annular groove 40, in the first member in the mutually coupled condition of the first and second members. <IMAGE>

Description

OSTOMY COUPLING This invention relates to a coupling for fixing an ostomy bag to a pad or surgical dressing.

Such couplings have been proposed. Examples can be seen in British Patents Nos. 1,571,657; 2,121,902 and 2,254,785. It has been found that the comfort in wear, and the security of attachment of the bag to the pa4, are seriously affected if it is possible for one coupling part to tilt relative to the other. In this context, "tilt" refers to a twisting possibly with partial deformation of a channel-shaped coupling member so that its planar surface, to which a medical grade adhesive pad is normally attached, lies substantially out of a plane located perpendicular to the axis of the coupling. It will be understood that an ostomy coupling normally has a circular stomal orifice, and the axis referred to is a line normal to the plane of that orifice and passing through the centre of the orifice.Such a tilt might be caused in use, for example, because the weight of the bag contents applies a force transverse to the coupling axis.

Another problem arising with ostomy couplings is that if the slightest leakage occurs, it is usually extremely embarrassing for the wearer.

It has been proposed, in our International Patent Application No. W093/23229, that a coupling element for use in an ostomy coupling should comprise an annular body provided with an undercut formation, said formation comprising a series of arcuate sections alternating with spaces, a plurality of the arcuate sections each having an undercut radially extending surface which subtends an angle to the axis of the body sufficient to give a required degree of security to the coupling element in respect of its attachment to a counterpart coupling element. With such an arrangement, the thinning of the base of the coupling element which occurs due to the presence of a ring-like array of spaced recesses, may reduce the stiffness of the element and hence may increase the likelihood of undesired leaks.

The aim of the present invention is to provide an ostomy coupling ,n which these difficulties are eliminated or at least greatly reduced.

According to the present invention, there is provided an coupling for joining a pad or dressing to an ostomy bag including a first member of closed loop form for defining a stomal aperture therein, the first member having a formation which defines two opposed walls, and a second member of closed loop form also defining a stomal aperture, the second member having an annular first rib which can be positioned between the two walls, and from which rib extends a flexible annular seal element dimensioned and positioned to resiliently bear against one of the walls, when the members are connected, in such a way as to make sealing engagement with said one wall, the base of the first rib being integral with or secured to a radially extending flange, characterised in that the second member has an annular second rib which faces towards the first member and extends into a complementary annular groove in the first member in the mutually coupled condition of the first and second members.

In an embodiment of the invention, each coupling member is of resilient synthetic plastics material.

The first member may be secured to the bag and the second member may be secured to the pad or dressing. Alternatively, the first member may be secured to the pad or dressing and the second member secured to the bag. The first of these alternatives is preferred.

The invention will be better understood from the following non-limiting description of an example thereof given with reference to the accompanying drawings in which: Figure 1 is a cross-sectional view, taken on a radial plane intersecting the coupling axis, showing part of one example of an ostomy coupling according to the invention with the two coupling members in their mutually coupled condition; and Figure 2 is a view similar to Figure 1 showing an alternative embodiment according to the invention.

In this specification, the terms "top" and "bottom" are used as applied to the representations of the parts as shown in Figures 1 and 2. These words are used for descriptive purposes and are not used by way of limitation of the scope of the claims.

It will be appreciated that in practical use the body side flange 22 bearing the medical grade adhesive pad will be located nearest to the skin of the wearer and the channel shaped coupling member 10 will be further from the skin of the wearer.

The illustrated ostomy coupling comprises a first member 10 and a second member 20 which, in use, both surround a stomal orifice 30. It will be understood from Figures 1 and 2 that the coupling members 10 and 20 are of closed-loop usually annular form surrounding a usually circular stomal orifice and that Figures 1 and 2 each show only one end of a radius, the other end parts being a mirror-image. In the embodiment illustrated, the first member is the bag side member and the second member is the body side member but in an alternative embodiment these may be reversed. A bag or pouch (not shown) for collection of discharge wastes, is secured, e.g. by heat welding, to a surface 10A of the first member 10. A medical grade adhesive pad is secured in any convenient way to the surface 21 of the flange 22. The medical grade adhesive pad may be made as disclosed by Chen in U.S.

Patent 3,339,546; by Chen et al in U.S. Patent No. 4,192,785; by Pawelchak et al in U.S. Patent No. 4,393,080; or by Doyle et al in U.S. Patent No. 4,551,490, the entire disclosures of each of which are deemed to be included herein.

The first member 10 is basically in the form of an annular channel having an inner wall 11, an outer wall 12, and a base 13.

It has been found that when a bag is heat or RF welded to the annular channel member 10, the plastics of the member 10 may become affected by the application of energy in that area, resulting in a tendency for the member 10 to be more readily deformed. An undesired tilting or bending of the radially outer portion of the member 10 is thus likely to occur.

The inner surface 13A of the base 13 is formed, by injection moulding for example, to have two levels and a series of arcuately spaced recesses. The first level is constituted by an annular surface 14 disposed adjacent to the wall 12. The second level is constituted by an annular surface 15 located adjacent to the inner wall 11. A plurality of recesses 16 are provided in the surface 15. These recesses are equally arcuately spaced in a peripheral sense. There may, for example, be 6, 8, 12 or 24 such recesses. It will be realised that the surface 15 is interrupted at regular intervals by the recesses 16. These recesses are provided to facilitate manufacture by a moulding method such as is disclosed in Application W093/23229.

The second coupling member 20, as stated, comprises an annular flange 22 integral with a first rib 23 and a flexible resilient sealing strip 24. The rib 23 is substantially cylindrical in shape with the strip 24 on its radially inner side and a rim 25, having a flat lower surface 25A, on its radially outer side. The strip 24 makes sealing engagement with the external surface of the wall 11. The top surface 23A of the rib is smoothly curved except for the presence of a second rib 26 which, when the two coupling members are mutually coupled, extends towards and desirably engages the surface 15 of the coupling member 10. The rib 26 extends continuously around the coupling member 20. The presence of the second rib 26, which has a substantially flat top surface 26A, is important in that it serves several purposes. Firstly it accurately locates the member 20 within the annular channel of the member 10; secondly its engagement with wall 14 of the base 13 tends to prevent relative twisting or tilting between the members 10 and 20, and thirdly in the event that the interfit and inter-engagement between the rim 25 and the wall 12 becomes ineffective, it serves to impede leakage of bag contents to the exterior.

The rim 25, in the coupled condition of the members 10 and 20, engages an overhanging surface 12A on the wall 12. This inter-engagement holds together the two coupling members 10 and 12. The extent of inter-engagement is chosen so that the two parts can be peeled apart manually, to enable a bag to be changed. The second rib 26 has sloping sides 26B, each being sloped a few degrees, e.g. between 10 and 20 , preferably about 15 to the central axis of revolution of the coupling. The confronting surface 13C on the base 13 is sloped at substantially the same angle.

An alternative embodiment of the invention is illustrated in Figure 2. Like parts have like reference numerals. The Figure 2 design resembles the Figure 1 design, except that the second rib, 36 in Figure 2, co-operates with a continuous annular groove 40. In other words, in the coupled condition of the members 10, 20 the second rib 26 extends into the groove 40 and substantially prevents any twisting or deformation of the assembled coupling. Hence the wearer can be more confident that an embarrassing leakage will not occur. This groove 40 is adjacent to, and radially outward of, the array of spaced recesses 16 in the base 13. The groove 40 is deeper than each of the recesses 16. It may for example be 1+ times as deep. The groove has a flat bottom and sloping sides 40A, 40B, the side 40B being an intermittent surface which bounds the radially outer ends of the bands which separate the individual recesses 16.

Claims (6)

1. The coupling for joining a pad or dressing to an ostomy bag includes a first member of closed loop form for defining a stomal aperture therein, the first member having a formation which defines two opposed walls, and a second member of closed loop form also defining a stomal aperture, the second member having an annular first rib which can be positioned between the two walls, and from which rib extends a flexible annular seal element dimensioned and positioned to resiliently bear against one of the walls, when the members are connected, in such a way as to make sealing engagement with said one wall, the base of the first rib being integral with or secured to a radially extending flange, characterised in that the second member has an annular second rib which faces towards the first member and extends into a complementary annular groove in the first member in the mutually coupled condition of the first and second members.

2. A coupling according to claim 1 in which the second rib is flat-topped and has sloping sides.

3. A coupling according to claims 1 or 2 in which the groove in the first coupling member is flat-bottomed and has sloping sides.

4. A coupling according to claims 1, 2 or 3 in which the sides of the second rib or of the groove, as the case may be, are disposed at an angle of 10 to 20 degrees to the central axis of revolution of the coupling.

5. An ostomy coupling substantially as herein described with reference to and as illustrated in Figure 1 or Figure 2 of the accompanying drawings.

6. All novel combinations or sub-combinations of features disclosed and/or illustrated herein.