GB2179556A - Ostomy appliance - Google Patents

Abstract

An improved ostomy appliance has two interengageable coupling elements, one of which 14 (herein called the body side coupling element) is secured to a medical grade adhesive pad 16 and the other side of which 12 is secured to an ostomy bag 10. A flexible chute ring 30 is interposed between the body side coupling element 14 and the adhesive pad 16 and has a radially inner annular region 42 which is connected to the pad and a radially outer annular region 46 which is connected to the coupling ring 14. <IMAGE>

Description

SPECIFICATION Ostomy appliance This invention relates to an ostomy appliance.

The ostomy appliance shown in British Patent Spec. No. 1 571 657 has received wide acceptance and approval among those persons needing to wear an ostomy bag. It has been realised more recently (see British Patent Application No. 15288) that it can be desirable to provide an appliance with enhanced flexibility so that any possible discomfort tothewearerisminimised. Furthermore, many current designs of ostomy appliance exhibit crevices or other zones where discharged faecal material can stickoraccumulate. This is readily seen to be undesirable as it means that bag changing is necessarily a messy and unhygienic operation.

It is an aim of the present invention to provide an improved ostomy appliance of the type which has two interengagable coupling elements, one of which (herein called the body side coupling element) is, or can be, secured to a medical grade adhesive pad and the other side of which is, or can be, secured to an ostomy bag.

According to the present invention, a flexible chute ring is interposed between the bodysidecoupling element and the adhesive pad.

With such an arrangement, a chute portion ofthe ring entirely eliminates or greatly reduces the chance that particles of discharged matterwill become lodged on or in the bag side coupling element, and the said element and the pad can be together in such a way as to facilitate coupling and uncoupling ofthe appliance in a mannerwhich minimises discomfort to the wearer.

According to an advantageous feature ofthe invention, the flexible chute ring is secured to the adhesive pad ata firstannular region which is radially inwardly ofthe coupling and to the body side coupling element at a second annular region which is radially outwardly of the first annular region.

According to a preferred feature ofthis embodiment ofthe invention, the second annular region has a greater radial extentthan the first. This leads to the desirable resultthatthe flexible chute ring can flex at a region just radially outwardly of the first annular region so allowing a wearerto get his finger orthumb behind the chute ring and between the latter and the adhesive pad.

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 a diagrammatic axial cross section through one example of ostomy in accordance with the invention; Figure 2 is a view showing coupling by the wearer of a bag and bag side coupling element to a pad and body side coupling element, using a finger and thumb, and illustrating how the chute ring enables thewearerto get his thumb under an outer peripheral portionofaflangeonthebodyside coupling element; Figure 3 shows the cross-sectional shape of one preferred form of flexible chute ring; Figure 4 is a cross-sectional detail view showing part of an alternative configuration for the flexible chute ring;; Figure 5 is a part-sectional view of an optional but advantageous version ofthe rim end ofthe chute ring showing an external peripheral pip or bump located to substantially coincide with an edge of a bag side coupling elementwhich is innermost, relative to the bag,the pip or bump serving two purposes, namely to help to hold the flexible chute ring in its assembled position and secondly to help to close off any crevice existing between the bag side coupling element and the bag wall to which it is secured; Figures 6 and 7 illustrate, on a smaller scale, alternative configurations of flexible chute ring, and Figure 8 is a diagrammatic illustration of a possible method of manufacture of an ostomy appliance showing an alternative (but presently less preferred) design offlexible ring, and indicating the sequence of welding steps; in the illustration the body side coupling element is shown for clarity, but in fact, in the manufacture, the bag side coupling element alone would be welded to the intervening flexible ring.

In the drawings, like parts are indicated by like reference numerals.

Referring firstly to Figure 1, the illustrated ostomy applianceincludesabag 10,abagsidecoupling element 12, a body side coupling element 14, and a pad 16 of medical grade adhesive. Suitable medical grade adhesives are those sold underthetrade names"Stomahesive"or"Varihesive", by E. R.

Squibb & Sons Limited andlortheir associated companies throughout the world, but other medical grade adhesives designed for ostomates and available on the market are also suitable.

The ostomy bag 10 hasstomal aperture 18 in its body side wall, and the bag 10 is fixed in any suitable mannerforexamplebya plasticsweldingoperation to the bag side coupling element 12 with the aperture 18 in registry with the stomal orifice 20 which is defined by the coupling elements. The coupling elements 12 and 14 are constructed to interengage and the element 14 has a deflectable sealing skirt 22.

For a fuller description of these features, the reader is referred to British Patent Specifications Numbers 1 568 860 and 1 571 657.

The outer periphery ofthe medical grade adhesive pad 16 has welded thereto, by a weld 24, an annular cover sheet 26 which serves to coverthe outer edge 28 of the adhesive pad 16.

According to the present invention, a flexible chute ring 30 is interposed between the body side coupling element and the adhesive pad 16. The ring 30 has chute portion 32 and a flange portion 34. As illustrated it also has an outer marginal bead 36 but this is not essential. The flexible chute ring 30 also has a zone of weakening or increased flexibility 31, which may be constituted by the bend 31 as shown in Figure 1 but a notch 31 a as shown in Figure 6 or by a thin region 31 b as shown in Figure 7 can equally well be used. The purpose of the zone of weakening or zone of increased flexibility 31 to facilitate some bending of the flexible chute ring so that a wearer can interpose a finger or a thumb as shown in the Figure 2 between the pad 16 and the ring 30.This is of particular assistance when coupling the coupling elements 12 and 14 together.

Athin layer of plastics film 40 advantageously covers the adhesive pad 16, this being present so that other parts can be secured to the pad 16 by plastics welding operations. According to an advantageous feature of the present invention, the flexible chute ring 30 is secured to the film 40 and hence to the pad 16 by a plastics welding operation at a first annular region 42 which is radially inwardly of the ring 30, with reference to the coupling axis 44.

In Figures 1 and 2 the plastics weld is diagrammatically represented by vertical lines. Also according to an advantageous feature of the invention, the flexible chute ring 30 is secured to the body side coupling element 14 by a plastics welding operation at a second annular region 46. The region 46 is radially outwardly of the region 42. As can be seen from Figures 1 and 2, the radial extent of the weld region 46 is greater that the radial extent of the weld region 42. The lesser the radial extent of the weld region 42, the easier is the thumb insertion illustrated in Figure 2, but naturally a sufficent radial extent of weld 42 must be employed to give security of attachment between the film 40 and the ring 30. In Figure 2, a wearer is seen connecting the coupling elements 12 and 14 by pressure between thumb 50 and index finger 52.

Figure 3 illustrates the flexible chute ring 30 having a chute portion 32, a zone of increased flexibility 31, a flange 34 and a marginal bead 36.

There is a step configuration between the flange portion 34 and an inner portion generally indicated at 54. The surface 56 is that which is welded to the film 40 whereas the surface 58 is that which is welded to a flange of the body side coupling element 14.

Figure 4 shows an alternative version of flexible chute ring, the ring shown in Figure 4 being suitable for use with the body side coupling element 60 having a flange 62 which is radially more extensive than the flange 15 of the body side coupling element 14. The ring 64 shown in Figure 4 has a chute portion 66, an increased flexibility zone of weakening 68, and an annularflange region 70 which is welded to the flange 62 of the coupling element 60. The manner of operation use of the flexible chute ring 64 is similar to that of the ring illustrated in Figures 1 and 2.

Figure 5 illustrates the formation in which the chute portion 32 ofthe ring 30 has a pip or bead 74 which serves two purposes, firstly to close off a crevice such as crevice 76 which may exist between the bag wall 10 and the coupling element 12 and secondly to hold the ring 32 assembled to the coupling element 12 and to provide a liquid seal between these two parts. A like pip or bead 74 may also be included on the flexible chute ring 64 of Figure 4.

It will be appreciated that in use there is a passage of faecal material through the stomal orifice 20 and it can readily be seen from Figures 1 and 2 that the chute portion 32 of the flexible ring 30 entirely eliminates or greatly reduces any chance of such faecal material becoming trapped or lodged in or on the coupling elements 12 and 14, in particular in the spaces indicated at 80 and 82 in Figure 1. In addition, the presence of the flexible ring 30 and the arrangement of the securing welds 42 and 46 is highly advantageous in enabling a wearer to conveniently and effectively couple the two coupling elements 12 and 14 together, without any substantial pressure being applied on tender areas of the body in the peristomal region.It will also be appreciated that the flexible ring 30 could be secured to the film 40 and to the coupling element 14 by means other than plastics welding, for example by a suitable adhesive and the present invention is not to be regarded as limited to an arrangement in which a plastics welding operation is used for these purposes.

Figure 8 diagramatically illustrates one possible method of manufacture of an ostomy appliance using an alternative design of flexible ring 90. A bag side coupling element is shown at 92 and a body side coupling element at 94. A pad of medical grade adhesive is shown at 96 having a plastics film layer 98 secured thereto.

As stated, the manufacture would be conducted with the bag side coupling element 92 not present, and the first operation is to make a plastics weld in the direction A between the flange 100 of the coupling element 94 and an annular portion 102 of the flexible ring 90. As a second plastics welding operation, an annular region 104 of the flexible ring 90 is welded to the confronting annular zone 98A of the plastics film 98. This embodiment of the invention differs from that shown in Figures 1 and 2 in that the flexible ring 90 does not have a chute portion corresponding to chute portion 22 of the ring 30. The assembly procedure shown in Figure 8, could equally well be employed with a flexible ring such as ring 30 which does have a chute portion. For certain wearers, particularly those where the nature of the discharge is less likely to lead to clogging problems, a flexible intervening ring of the kind illustrated by 90 will be suitable.

The reader is referred to Application 83 29121, Serial No. 2 148 716, from which the present application is divided.

Claims (3)

1. A body side coupling for an ostomy appliance which includes a pad of medical grade adhesive, a coupling ring, and a flexible ring located between the pad that the coupling ring, the flexible ring having an outer portion extending outwardly radially of the coupling beyond the coupling ring, the flexible ring being connected to the pad at a radially inner annular region surrounding the stomal orifice and to the coupling ring at a second annular region which is spaced from and radially outwardly of the inner annular region.

2. A body side coupling according to claim 1 in which the radially outer portion of the flexible ring has a configuration such that a wearer can easily insert his/her thumbs between the flexible ring and the pad.

3. A body side coupling substantially as herein described with reference to and as illustrated in the accompanying drawings.