GB2311467A

GB2311467A - Ostomy appliance and adhesive flange therefor

Info

Publication number: GB2311467A
Application number: GB9606925A
Authority: GB
Inventors: Hugh Brady
Original assignee: Individual
Current assignee: Individual
Priority date: 1996-04-02
Filing date: 1996-04-02
Publication date: 1997-10-01
Anticipated expiration: 2016-04-02
Also published as: GB9606925D0; GB2311467B

Description

OSTOMY APPLIANCE AND ADRISIVE FLANGE THEREFOR The present invention relates to an ostomy appliance comprising a pouch and an adhesive flange coupled to the pouch and also relates to an adhesive flange for an ostomy appliance in cases where the appliance is of a two part or multi-part construction with the adhesive flange separate from the pouch.

Ostomy appliances are designed to be used by people who, for a number of clinical reasons, can no longer pass body waste, whether it be faecal or urinary, in the usual manner. Such a situation might occur, for example, where a large section of the intestines or bladder are diseased or damaged and where surgical intervention is required in order to form a stoma. There are three basic types of stoma: a colostomy; an ileostomy, both of which are concerned with faecal waste; and a urostomy, which is concerned with urinary waste. In all three cases an appropriate section of intestine or, in the case of a urostomy, the ureters, is diverted through the abdominal wall and the waste material collected in an ostomy appliance or stoma bag.

In the past these appliances have come in two forms: as a one piece system or as a two part or multi-part system. The one piece system consists of a bag which is generally formed of a plastics material such as PVDC which is then bonded to a means of adhering the bag to the abdomen. The material used for this is primarily hydrocolloid which is a mixture of pectin, gelatin, polyisobutylene and carboxymethycellulose bonded to an appropriate backing material and which is considered to be more friendly to the skin than previous materials such as zinc oxide, blenderm or microporous adhesives.

By contrast, the two part or multi-part systems comprise a "flange" of hydrocolloid material which is adhered to the abdomen in the usual way and a separate bag or pouch which is detachably mounted to the flange by means of a Tupperware-type seal. What both these forms of appliance have in common therefore is the hydrocolloid flange which is used to adhere both appliances to the abdomen. This hydrocolloid flange is currently manufactured in a range of shapes and sizes so that existing appliances may incorporate a square, circular, diamond or oval shaped flange.

Although some manufactures have made efforts to increase the flexibility of these hydrocolloid flanges by either progressively tapering the flange towards the edges or providing flanges of reduced thickness, the resulting flanges still lack sufficient flexibility. The reason why flexibility is important is that often the hydrocolloid flange has to adhere not to a flat even surface but to one which might include several skin folds. The surface to which the hydrocolloid flange must adhere might also include scar tissue, whilst hernias and other complications might also make it difficult for the flange to adhere effectively. When an ostomy appliance does not adhere properly then leakage can result causing distress to the patient and sore skin as a result of the leakage.

In order to avoid problems with leakage, there has been a tendency for manufactures to increase the surface area of the hydrocolloid flange. However, by increasing the surface area the flexibility of the resulting flange is simultaneously reduced.

Whilst hydrocolloid is accepted as causing fewer allergic reactions then previous adhesives, it still has the capacity to cause soreness to the skin and general discomfort. Thus, whilst increasing the surface area of the flange might reduce the risk of leakage, it not only decreases the resulting flexibility of the flange but also increases the risk of patient discomfort due to sore skin.

For the above reasons most hydrocolloid flanges are made to approximately the same 10cm x 10cm size which is regarded as being an acceptable balance between the desire to prevent leakage and the wish to ensure patient comfort. Despite this convergence of opinion, it would still be desirable to provide an ostomy appliance which offered the wearer increased comfort whilst not increasing the risk of leakage.

According to a first aspect of the present invention there is provided an ostomy appliance comprising a pouch and an adhesive flange coupled to the pouch for securing the appliance with respect to the skin of a wearer, the adhesive flange having an aperture which communicates with an interior of the pouch and comprising a plurality of fingers which extend away from the aperture.

According to a second aspect of the present invention there is provided an adhesive flange for an ostomy appliance comprising a pouch which is adapted to be coupled to the flange, the adhesive flange comprising an aperture capable of communicating with an interior of the pouch and a plurality of fingers which extend away from the aperture.

A number of embodiments of the present invention will now be described by way of example with reference to the accompanying drawings in which: Figure 1 is a plan view of an ostomy appliance in accordance with a first embodiment of the present invention; Figure 2 is a plan view of an ostomy appliance in accordance with a second embodiment of the present invention; and Figure 3 is a plan view of an ostomy appliance in accordance with a third embodiment of the present invention.

Referring initially to Figure 1, there is shown a one piece ostomy appliance 10 comprising a stoma bag 12 and an adhesive flange 14. The adhesive flange 14 is provided with a central apperture 16 and this apperture communicates with an interior of the stoma bag 12. In addition to the aperture 16, the adhesive flange 14 also comprises four fingers 18,20,22 and 24, each of which extends in a direction away from the aperture. In the example shown, each finger 18,20,22 and 24 extends in a generally rectilinear fashion and in a direction which is substantially uniformly angularly spaced around the periphery of the aperture 16. Thus, since there are four fingers 18,20,22 and 24, each extends in a direction which is substantially at right angles to the adjacent figures. For the purpose of assessing the surface area of the resulting flange 14, the fingers 18,20,22 and 24 can be thought of as extending along the diagonals of a rectangle 26 having sides whose length falls within the range from 10cm to 20cm.

In the embodiment shown in Figure 1 each finger 18,20,22 and 24 is in part defined by a respective pair of mutually spaced, parallel side edges 28 and 30 and terminates at an end remote from the aperture 16 in a respective generally curved edge 32. In a currently preferred embodiment this curved edge 32 merges smoothly with the two side edges 28 and 30.

At an end proximate the aperture 16, a respective side edge 28 of each of the fingers 18,20,22 and 24 merges smoothly with a respective arcuate edge 34.

This arcuate edge 34 in turn merges smoothly with a side edge 30 of an adjacent finger so that as one moves around the periphery of the flange 14 one does not encounter any sharp angles or other abrupt changes in direction.

The adhesive flange 14 may be formed of any convenient material although a conventional hydrocolloid mixture of pectin, gelatin, polyisobutylene and carboxymethylcellulose is currently preferred. The flange 14 preferably has a thickness of between 0.lmm and 1.5mm while the aperture 16 preferably has a maximum dimension of between 15mm and 60mm. Most stomas can be accommodated with an aperture having a maximum dimension of between 30mm and 55mm however, the flange as a whole is designed so as to provide sufficient adhesion even when an aperture having a maximum dimension of 60mm is cut from a central portion of the flange. In order to facilitate the cutting of different size apertures, the adhesive flange 14 may be overlain, at least initially, with a template 36 on which there is marked a series of concentric circles or oval shapes of different dimensions. Once the desired aperture 16 has been cut from the flange 14, the template 36 can be removed prior to the application of the flange to the abdomen of the wearer.

The ostomy appliance illustrated in Figure 1 has a number of advantages over those of the prior art.

By providing a flange 14 having a plurality of fingers 18,20,22 and 24 it has been found that even though the resulting flange may be of smaller surface area than those of the prior art, it is possible to achieve a greater adherence, particularly on uneven and herniated abdomens as a result of the flange's higher degree of flexibility. Another advantage is that by reducing the surface area of the flange 14, the area of skin in permanent contact with the hydrocolloid material is also reduced thereby minimising the problems associated with "skin stripping" caused by constant application and removal of hydrocolloid material. Indeed, by rotating the flange 14 through 900 on each re-application of the appliance 10, it is possible to "rest" those areas of the skin which lie between adjacent fingers. Thirdly, by providing a flange 14 comprising a plurality of fingers 18,20,22 and 24, the removal of the appliance 10 is rendered less painful since each finger may be peeled back in turn rather than stripping away the entire flange 14 in one operation as is required by the appliances of the prior art.

A second embodiment of the present invention is illustrated in Figure 2. In this embodiment the adhesive flange 14' comprises only three fingers 18',20' and 22' however, as with the first embodiment, each finger extends in a direction which is substantially uniformly angularly spaced around the periphery of the aperture 16'. Since there are three fingers 18',20' and 22', this means that each finger extends in a direction spaced by 1200 from the two neighbouring fingers.

In contrast to the first embodiment, each of the fingers 18',20' and 22' are not in part defined by a respective pair of mutually spaced, parallel side edges 28 and 30. Instead, each finger 18',20' and 22' is substantially pear shaped with the larger lobe portion of the pear at an end remote from the central aperture 16'. To this end the side edges 28' and 30' diverge slightly before each in turn merges with the generally curved edge 32'.

As with the first embodiment, the side edges 28' and 30' of adjacent fingers merge and an end proximate the central aperture 16' via a respective arcuate edge 34'. Since the fingers 18',20' and 22' are spaced to a greater extent than the fingers of the first embodiment, this arcuate edge 34' may be considered as comprising part of a central hub 38' from which the three fingers extend.

The advantage of providing an adhesive flange 14' in which the fingers are generally pear shaped or at least have a width which is greater in a region remote from the central aperture 16' than in a region proximate the central aperture, is that the resulting flange has an increased adherence capability while losing nothing in terms of its flexibility.

Another way of achieving the same result is shown in Figure 3 in which the adhesive flange 14" comprises two oppositely directed fingers 18" and 20". Each finger 18" and 20" is provided with a respective cross-piece 40" which extends from the finger at an angle to the general direction in which the finger extends.

It will be apparent to those skilled in the art that the present invention is not limited to the number or shape of the fingers with which the adhesive flange is provided. In particular, the number of fingers is not limited to the numbers shown in the embodiments described and in principle any number of fingers may be provided. Likewise, the shape of the fingers is not limited to the embodiments illustrated, neither is the invention limited to having fingers which are all of the same shape.

Likewise, although the present invention has been described with reference to a one piece ostomy appliance, it will be apparent to those skilled in the art that the present invention is not limited to such appliances. Indeed, two part or multi-part ostomy appliances may also benefit from the present invention since the adhesive flange may be easily adapted to accommodate a conventional seal, whether it be of the Tupperware-type or another type, by which the flange can be selectively coupled and de-coupled to an associated stoma bag or pouch.

Claims

CLAIMS:

1. An ostomy appliance comprising a pouch and an adhesive flange coupled to the pouch for securing the appliance with respect to the skin of a wearer, the adhesive flange having an aperture which communicates with an interior of the pouch and comprising a plurality of fingers which extend away from the aperture.

2. An appliance in accordance with claim 1, wherein the fingers extend in directions which are substantial uniformly angularly spaced around a periphery of the aperture.

3. An appliance in accordance with claim 1 or claim 2, wherein one or more of the fingers extend in a generally rectilinear fashion.

4. An appliance in accordance with any preceding claim, wherein one or more of the fingers terminate at an end remote from the aperture in a respective generally curved edge.

5. An appliance in accordance with claim 4, wherein one or more of the fingers is in part defined by a respective pair of side edges, said side edges merging smoothly with said generally curved edge at an end of the finger remote from the aperture.

6. An appliance in accordance with any preceding claim, wherein each of the fingers is part defined by a respective pair of side edges, a side edge of one of the fingers merging smoothly with an arcuate edge at an end of the finger proximate the aperture, said arcuate edge in turn merging smoothly with a side edge of an angularly adjacent finger.

7. An appliance in accordance with any preceding claim, wherein one or more of the fingers is in part defined by a respective pair of parallel side edges.

8. An appliance in accordance with any of claims 1 to 6, wherein one or more of the fingers is in part defined by a respective pair of side edges, said side edges diverging in a direction away from the aperture such that the distance between the edges increases with the distance from the aperture.

9. An appliance in accordance with any preceding claim, wherein one or more of the fingers is provided with a cross-piece which extends from the finger at an angle to the general direction in which the or each finger extends.

10. An appliance in accordance with any preceding claim, wherein the adhesive flange is formed of hydrocolloid.

11. An appliance in accordance with any preceding claim, wherein the flange has a thickness within the range from 0.lam to 1.5mm.

12. An appliance in accordance with any preceding claim, wherein the shape of the adhesive flange is such that it may be cut from a rectangle having sides whose length is in the range from 10cm to 20cm.

13. An appliance in accordance with any preceding claim, wherein the aperture has a maximum dimension within the range from 15mm to 160mm.

14. An appliance in accordance with any preceding claim, wherein the pouch is adapted to be selectively coupled and/or de-coupled from the adhesive flange.

15. An ostomy appliance substantially as herein described with reference to the accompanying drawings.

16. An adhesive flange for an ostomy appliance comprising a pouch which is adapted to be coupled to the flange, the adhesive flange comprising an aperture capable of communicating with an interior of the pouch and a plurality of fingers which extend away from the aperture.

17. An adhesive flange in accordance with claim 16, wherein the fingers extend in directions which are substantial uniformly angularly spaced around a periphery of the aperture.

18. An adhesive flange in accordance with claim 16 or claim 17, wherein one or more of the fingers extend in a generally rectilinear fashion.

19. An adhesive flange in accordance with any of claims 16 to 18, wherein one or more of the fingers terminate at an end remote from the aperture in a respective generally curved edge.

20. An adhesive flange in accordance with claim 19, wherein one or more of the fingers is in part defined by a respective pair of side edges, said side edges merging smoothly with said generally curved edge at an end of the finger remote from the aperture.

21. An adhesive flange in accordance with any of claims 16 to 20 wherein each of the fingers is part defined by a respective pair of side edges, a side edge of one of the fingers merging smoothly with an arcuate edge at an end of the finger proximate the aperture, said arcuate edge in turn merging smoothly with a side edge of an angularly adjacent finger.

22. An adhesive flange in accordance with any of claims 16 to 21, wherein one or more of the fingers is in part defined by a respective pair of parallel side edges.

23. An adhesive flange in accordance with any of claims 16 to 21, wherein one or more of the fingers is in part defined by a respective pair of side edges, said side edges diverging in a direction away from the aperture such that the distance between the edges increases with the distance from the aperture.

24. An adhesive flange in accordance with any of claims 16 to 23, wherein one or more of the fingers is provided with a cross-piece which extends from the finger at an angle to the general direction in which the or each finger extends.

25. An adhesive flange in accordance with any of claims 16 to 24, wherein the adhesive flange is formed of hydrocolloid.

26. An adhesive flange in accordance with any of claims 16 to 25, wherein the flange has a thickness within the range from 0.lmm to 1.5mm.

27. An adhesive flange in accordance with any of claims 16 to 26, wherein the shape of the adhesive flange is such that it may be cut from a rectangle having sides whose length is in the range from 10cm to 20cm.

28. An adhesive flange in accordance with any of claims 16 to 27, wherein the aperture has a maximum dimension within the range from 15mm to 160mm.

29. An adhesive flange in accordance with any of claims 16 to 28, wherein the flange is adapted to be selectively de-coupled from the pouch.

30. An adhesive flange for an ostomy appliance, the adhesive flange being substantially as herein described with reference to the accompanying drawings.