WO2012056224A1

WO2012056224A1 - Ostomy appliance

Info

Publication number: WO2012056224A1
Application number: PCT/GB2011/052065
Authority: WO
Inventors: Peter Argent
Original assignee: Salts Healthcare Limited
Priority date: 2010-10-29
Filing date: 2011-10-25
Publication date: 2012-05-03
Also published as: GB2484978A; GB201018308D0

Abstract

An ostomy appliance (10) including: - a first wall (12) and a second wall (14) which are connected to each other to define a cavity for receipt of waste; a first aperture (16) provided in the first wall for receipt of a stoma; and a second aperture (18) provided in the first or second wall to permit waste gases to exit from the cavity during use; wherein the appliance includes a berrier member (30) through which waste gases must pass during use to exit the appliance, the barrier member including a portion which is permeable to waste gases but impermeable to liquid waste.

Description

Title: Ostomy Appliance Description of Invention

The invention relates to an ostomy appliance for collecting human waste. Whilst the invention has been devised primarily in relation to a drainable ostomy appliance, it should be understood that the invention can be utilised in non-drainable ostomy appliances. The invention is applicable to both one piece and two piece ostomy appliances.

It is known to provide in a wall of an ostomy appliance ('bag' or 'pouch' as they are commonly known in the art) an aperture to permit waste gases to escape from the ostomy appliance in use. This is necessary to prevent the bag expanding with gas pressure and potentially for leakage or bursting whilst filled with waste. In some prior art ostomy appliances the aperture is covered by a filter, the purpose of which is to de-odorise the waste gases before they exit to atmosphere. In the known ostomy appliances the aperture/filter is usually, but not always, positioned in an upper part of the bag, above the opening to the bag which receives the stoma.

For colostomy appliances, where the waste is solid/semi-solid, such a configuration is usually satisfactory, because waste rarely comes into contact with the upper part of the bag where the aperture/filter is located. However, ileostomy appliances are used for patients with an ileum stoma, and the waste which exits through this stoma is usually in liquid form. This often results in the aperture/filter becoming blocked (particularly at night when the patient is laying in bed) which preventing gas from exiting the chamber.

According to the present invention, we provide an ostomy appliance including:- a first wall and a second wall which are connected to each other to define a cavity for receipt of waste;

a first aperture provided in the first wall for receipt of a stoma; and a second aperture provided in the first or second wall to permit waste gases to exit from the cavity during use;

wherein the appliance includes a barrier member through which waste gases must pass during use to exit the appliance, the barrier member including a portion which is permeable to waste gases but impermeable to liquid waste.

Further features of the invention are set forth in the dependent claims.

Embodiments of the invention will be described by way of example only with reference to the accompanying drawings, of which:-

Figure 1 a schematic (i.e. not to scale) side cross-sectional view of a first embodiment of an ostomy appliance in accordance with the present invention;

Figure 2 is a schematic front view of the ostomy appliance of figure 1 ;

Figure 3 is a schematic plan view of part of a first embodiment of a barrier member in accordance with the present invention;

Figure 4 is a schematic plan view of a second embodiment of a barrier member in accordance with the present invention;

Figure 5 is a schematic front view of a second embodiment of an ostomy appliance in accordance with the present invention; Figure 6 is a schematic side cross-sectional view of the ostomy appliance of figure 5; Figure 7 is a schematic front view of a third embodiment of an ostomy appliance in accordance with the present invention; Figure 8 is a schematic side cross-sectional view of the ostomy appliance of figure 7;

Figure 9 is a schematic front view of a fourth embodiment of an ostomy appliance in accordance with the present invention; and

Figure 10 is a schematic side cross-sectional view of the ostomy appliance of figure 9.

Referring firstly to figures 1 to 3 there is shown an ostomy appliance 10 in accordance with the present invention. The appliance 10 includes a first wall 12, a second wall 14 and an intermediate barrier member 30 sandwiched therebetween. The first 12, second 14 and barrier member 30 are made from sheet plastics materials, the composition of which are well known in the art of ostomy appliances. The first 12, second 14 and barrier member 30 are preferably welded to each other at or near their peripheries so as to form a cavity for receipt of waste. In the present example the ostomy appliance 10 is for use with an ileum stoma, and thus includes an outlet 22 at a lower end thereof through which waste can be drained from the cavity. As is also shown in figure 1 , the appliance 10 includes a hydrocolloid annular member 15, which is connected to an exterior surface of the first wall 12 and which includes an aperture 16 for receipt of a stoma. The appliance 10 includes a further wall 13 positioned exterior to the wall 12. The wall 13 is made from a, usually soft, material which increases user comfort (the rear of the appliance 10 abuts the skin of a user). The appliance 10 also includes a plurality of further walls 17a, 17b, 17c, 17d which are connected and are positioned exterior to the wall 14. These walls 17a, 17b, 17c, 17d are configured as is well known in the art and thus will not be discussed in any further detail. The outlet 22, as can be seen from figures 1 and 2, includes fastening means 24, 25 to facilitate closing of the outlet 22. The lower most ends of the walls 12, 14 and 30 are rolled up and then held in position to prevent any waste from exiting through the outlet 22. Such a configuration is also well known in the art.

The second wall 14 includes an aperture 18 which, as can be seen from figures 1 and 2 is positioned laterally to one side of a general centre line of the appliance 10 and upwardly from the aperture 16 in the first wall 12. The aperture 18 is provided to permit waste gases to exit from the cavity, between the walls 12 and 14, to atmosphere. An exterior side (it could be on the interior side, however) of the aperture 18 is covered by a filter 20 the purpose of which is to de-odorise waste gases which pass through the aperture 18 before exiting to atmosphere. It should be appreciated that the aperture 18 and the filter 20 could be positioned at any location, on the first 12 or second 14 walls.

As mentioned above, the appliance 10 includes a barrier member 30 in accordance with the present invention, the purpose of which is to prevent or at least inhibit the aperture 18 and/or filter 20 from becoming blocked during use by waste. The barrier member 30 is configured such that any waste gases contained in the cavity must pass therethrough during use in order to exit the appliance 10 (when the outlet 22 is closed). As can be seen from figures 1 and 2 a number of different configurations of the barrier member 30 have been shown, each of which are in accordance with the present invention. It should be noted that the configurations of barrier member 30 are shown by way of examples and there are many other configurations which could be used to achieve the same technical effect.

The barrier member 30a is generally circular and is connected by any appropriate method (e.g. heat welding) to the second wall 14 such that it surrounds the aperture 18. It should be appreciated that the barrier member 30a need not be circular. All that is required is that it be connected to the wall 14 so that the only passage for waste gas from the cavity is through the barrier member 30a.

The barrier members 30b and 30c are similar in configuration. The only difference is that the barrier member 30c extends further downwardly towards the outlet 22 than the barrier member 30b. Both barrier members 30b and 30c are connected to the second wall 14 at or near their peripheries such that the only passage for waste gas from the cavity is through the barrier member 30b, or 30c, as the case may be.

The barrier member 30d is similar to the barrier member 30c except that it extends even further downwardly so that a lowermost end of barrier member 30d is positioned at or near an entrance to the outlet 22. The remainder of the periphery of the barrier member 30d is connected to the wall 14. In order to ensure that the only passage for waste gas from the cavity, during use, is through the barrier member 30d, the lowermost free end of the barrier member 30d is held between the fastening means 24 when the lowermost end of the appliance 10 is rolled up and the outlet 22 closed.

Two or more of the barrier members 30a, 30b, 30c, 30d may be used in combination in order to increase protection against blocking of the aperture 18 and/or filter 20, whilst permitting the exit of gases. Referring specifically to figure 3, this shows a magnified view of a region of the barrier member 30a, 30b, 30c, 30d. As can be seen, in the present example the barrier member 30 includes a plurality of groups 31 of apertures 31 a, the apertures 31 a being sized so as to permit waste gases to pass therethrough but which are sized so as not to permit liquid to flow therethrough. The apertures 31 a are created by a laser, although it should be appreciated that other techniques could be used.

In the present example, the groups 31 are positioned at regular intervals from each other, in an array, over the region of the barrier member 30. Looking more closely, it can be seen that each group 31 includes thirteen apertures 31 a which are configured in a diamond or rectangular array. It should be appreciated that more of fewer apertures 31 a can be provided in each group 31 . In addition, it should also be appreciated that groups 31 can be positioned in any number of different patterns in relation to each other.

Referring specifically to figure 4, this shows a second embodiment of a barrier member 30' for use as the barrier member in the first embodiment of ostomy appliance 10. Features which correspond to those shown in figure 3 have been given the same reference numeral with the addition of a prime symbol. As can be seen, the barrier member includes a plurality of groups 31 ' of apertures 31 'a. In this embodiment each group 31 includes an array of holes (twenty five in five rows of five apertures). Each aperture has a diameter of between 3 and 20 microns, preferably 3 to 15 microns, more preferably 3 to 8 microns, and most preferably 3 to 5 microns. Preferably the apertures 31 'a are each substantially the same diameter. In the embodiment shown in figure 4 the apertures 31 'a are positioned such that their centres are spaced at 100 microns from each other, horizontally and vertically. Each array of apertures is spaced at between 10mm and 20mm from adjacent arrays, both vertically and horizontally. During use, the barrier member 30 permits waste gases to exit from the cavity of the appliance 10, but inhibits or prevents any waste from coming into contact with or blocking the aperture 18. This is highly advantageous, especially for ileostomy appliances where the waste is usually in liquid form. Even if waste comes into contact with the barrier member 30, the apertures 31 a, 31 'a therein are small enough such that they will not likely become blocked. Even if some of the apertures 31 a, 31 'a do become blocked, there will still be some remaining apertures 31 a, 31 'a through which waste gases can exit the cavity.

Although not shown in the figures, the barrier member, rather than being connected to the first or second walls could be formed as an integral part of the first or second walls, i.e. a section/area of the wall including apertures for the exit of gases.

It should also be appreciated that the size (i.e. diameter/shape) of, or a proportion of, the apertures 31 a, 31 'a may be adjusted so as to provide regulation of the waste gas to atmosphere, to prevent or at least inhibit the first and second walls from coming into contact with each other. In other words, smaller holes would provide a lower flow rate of waste gas through the barrier member, whereas larger apertures would increase the flow rate of gas. In each of the above examples herein described, flow rates (at a pressure of 1 psi in the cavity) of waste gas existing the apparatus of 20 litres per hour, 50 litres per hour, 70 litres per hour, or even up to 100 litres per hour are achievable.

Referring to figures 5 and 6 these show a second embodiment of an ostomy appliance in accordance with the present invention. Features which correspond to those shown in the first embodiment (figures 1 and 2) have been given the same reference numeral with the addition of a double prime symbol. The ostomy appliance 10" includes a pair of barrier members 51 , 52, which are positioned one behind the other and are connected to the walls 12", 14" of the appliance 10" around their peripheries by any appropriate method (e.g. heat welding). A lowermost end of each barrier member 55, 56 is connected at 70 to the wall 12" across its width and spaced from the outlet 22"'. The barrier members 51 , 52 are similar in shape and position to the barrier member 30b in the first embodiment. The provision of a pair of barrier members, used in combination, increases the protection against blocking of the apertures therein and/or the filter 20" whilst permitting the exit of gases from the cavity. Waste gases must past firstly through the first barrier member 51 and then subsequently through the second barrier 52 in order to exit the appliance, through the filter 20". In one proposal the diameter of each of the apertures in the first barrier member 51 is larger than the diameter of each of the apertures in the second barrier member 52. In an alternative proposal the diameter of each of the apertures in the second barrier member 52 is larger than the diameter of each of the apertures in the first barrier member 51 . In yet a further proposal the diameter of the apertures in the first and second barrier members 51 , 52 are the same.

Although not shown in the drawings means may be provided for maintaining an air passage from the first barrier member 51 to the second barrier member 52. Such means may be the provision of at least one spacing member positioned between a first and second barrier members 51 , 52. Alternatively, or in addition to the at least one spacing member, the facing surfaces of the first and second barrier members 51 , 52 may be textured, contoured and/or embossed, in order to prevent those surfaces from adhering to each other in the presence of moisture, thus maintaining a passageway for gases to escape from the cavity, thus maintaining a passageway for exhaust gases to escape.

Referring to figures 7 and 8, these show a third embodiment of an ostomy appliance in accordance with the present invention. Features of which correspond to those used in the first embodiment (figures 1 and 2) have been given the same reference numeral with the addition of three prime symbols. The third embodiment 10"' is similar to the second embodiment in that two barrier members 55, 56 have been provided.

Whereas in the second embodiment the peripheries of the first and second barrier members 51 , 52 are heat welded, or otherwise connected, to the walls 12", 14" of the appliance at their peripheries, the barrier members 55, 56 in the third embodiment are heat welded, or otherwise connected at 71 , to the wall 12"' spaced from a periphery of the wall 12"'. A lowermost end of each barrier member 58, 59 is connected at 72 to the wall 12"' across its width and spaced from the outlet 22"'.

The provision of a pair of barrier members, used in combination, increases the protection against blocking of the apertures therein and/or the filter 20"' whilst permitting the exit of gases from the cavity. Waste gases must past firstly through the first barrier member 55 and then subsequently through the second barrier 56 in order to exit the appliance, through the filter 20"'. In one proposal the diameter of each of the apertures in the first barrier member 55 is larger than the diameter of each of the apertures in the second barrier member 56. In an alternative proposal the diameter of each of the apertures in the second barrier member 56 is larger than the diameter of each of the apertures in the first barrier member 55. In yet a further proposal, the diameter of the apertures in the first and second barrier members 55, 56 are the same.

As shown in figure 8, a spacing member 80 is provided for maintaining an air passage from the first barrier member 55 to the second barrier member 56 (one or more further spacing members could be provided). The spacing member 80 is sized slightly smaller than the space between the first 55 and second 56 barrier members. In the present example, the spacing member 80 is 'floating', in the sense that it is not connected or otherwise fixed to the first 55 or second 56 barrier members. The spacing member 80 could, however, be connected to either or both of the first 55 and/or second 56 barrier members. Alternatively, or in addition to the spacing member 80, the facing surfaces of the first 55 and second 56 barrier members may be textured, contort and/or embossed, in order to prevent those surfaces from adhering to each other in the presence of moisture, thus maintaining a passageway for gases to escape from the cavity.

Referring to figures 9 and 10, these show a fourth embodiment of an ostomy appliance in accordance with the present invention. Features which correspond to those used in the first embodiment (figures 1 and 2) have been given the same reference with the addition of four prime symbols. As can be seen from the figures, the ostomy appliance 10"" includes a pair of barrier members 58, 59, each of which is annular in frontal view. The barrier members 58, 59 are positioned one behind the other and provide a dual protection against leakage from the cavity to the filter 20"". The barrier members 58, 59 are heat welded, or otherwise connected at their inner 60 and outer 61 peripheries to the wall 12"" spaced.

The provision of a pair of barrier members, used in combination, increases the protection against blocking of the apertures therein and/or the filter 20"" whilst permitting the exit of gases from the cavity. Waste gases must past firstly through the first barrier member 58 and then subsequently through the second barrier 59 in order to exit the appliance, through the filter 20"". In one proposal the diameter of each of the apertures in the first barrier member 58 is larger than the diameter of each of the apertures in the second barrier member 59. In an alternative proposal the diameter of each of the apertures in the second barrier member 59 is larger than the diameter of each of the apertures in the first barrier member 58. In yet a further proposal, the diameter of the apertures in the first and second barrier members 58, 59 are the same. As shown in figure 10, an annular spacing member 81 is provided for maintaining an air passage from the first barrier member 58 to the second barrier member 59 (one or more further spacing members could be provided). The spacing member 81 is sized slightly smaller than the space between the first 58 and second 59 barrier members. In the present example, the spacing member 81 is 'floating', in the sense that it is not connected or otherwise fixed to the first 58 or second 59 barrier members. The spacing member 81 could, however, be connected to either or both of the first 58 and/or second 59 barrier members. Alternatively, or in addition to the spacing member 81 , the facing surfaces of the first 58 and second 59 barrier members may be textured, contort and/or embossed, in order to prevent those surfaces from adhering to each other in the presence of moisture, thus maintaining a passageway for gases to escape from the cavity.

When used in this specification and claims, the terms "comprises" and "comprising" and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or components.

The features disclosed in the foregoing description, or the following claims, or the accompanying drawings, expressed in their specific forms or in terms of a means for performing the disclosed function, or a method or process for attaining the disclosed result, as appropriate, may, separately, or in any combination of such features, be utilised for realising the invention in diverse forms thereof.

Claims

1 . An ostomy appliance including:- a first wall and a second wall which are connected to each other to define a cavity for receipt of waste;

2. An ostomy appliance according to claim 1 wherein the barrier member includes a plurality of apertures therethrough which are sized to as to permit waste gases to pass therethrough but which are sized so as not to permit liquid to flow thererthrough.

3. An ostomy appliance according to claim 2 wherein the apertures each have a diameter of between 3 and 20 microns.

4. An ostomy appliance according to claim 2 wherein the apertures each have a diameter of between 3 and 15 microns.

5. An ostomy appliance according to claim 2 wherein the apertures each have a diameter of between 3 and 8 microns.

6. An ostomy appliance according to claim 2 wherein the apertures each have a diameter of between 3 and 5 microns.

7. An ostomy appliance according to any one of claims 2 to 6 wherein the plurality of apertures are positioned at regular intervals.

8. An ostomy appliance according to any one of claims 2 to 7 wherein the plurality of apertures are arranged in groups of closely adjacent apertures.

9. An ostomy appliance according to any preceding claim including two barrier members, wherein waste gases must pass firstly through the first barrier member and then secondly through the second barrier member to exit the appliance.

10. An ostomy appliance according to claim 9 wherein the diameter of each of the apertures in the first barrier member is larger than the diameter of each of the apertures in the second barrier member.

1 1 . An ostomy appliance according to claim 9 wherein the diameter of each of the apertures in the second barrier member is larger than the diameter of each of the apertures in the first barrier member.

12. An ostomy appliance according to claim 10 or claim 1 1 including means for maintaining an air passage from the first barrier member to the second barrier member.

13. An ostomy appliance according to claim 12 wherein facing surfaces of the first and second barrier members are textured, contoured and/or embossed.

14. An ostomy appliance according to claim 12 or claim 13 including at least one spacing member positioned between the first and second barrier members.

15. An ostomy appliance according to claim 14 wherein the spacing member is a mesh or woven material.

16. An ostomy appliance according to any preceding claim wherein the or each barrier member is a further wall connected to or forming part of the first or second walls.

17. An ostomy appliance according to any preceding claim wherein the or each barrier member has a periphery and wherein a majority of the periphery is connected to the first or second wall.

18. An ostomy appliance according to any preceding claim wherein the or each barrier member has a periphery and wherein the entire periphery is connected to the first or second wall.

19. An ostomy appliance according to any preceding claim wherein the or each barrier member surrounds the second aperture.

20. An ostomy appliance according to any preceding claim wherein the or each barrier member is provided as an intermediate wall positioned between the first and second walls.

21 . An ostomy appliance according to any preceding claim wherein the barrier member(s) is configured to permit waste gases to exit the appliance at a rate of 20 litres per hour at a pressure of 1 psi in the cavity.

22. An ostomy appliance according to any preceding claim wherein the barrier member(s) is configured to permit waste gases to exit the appliance at a rate of 50 litres per hour at a pressure of 1 psi in the cavity.

23. An ostomy appliance according to any preceding claim wherein the barrier member(s) is configured to permit waste gases to exit the appliance at a rate of 70 litres per hour at a pressure of 1 psi in the cavity.

24. An ostomy appliance according to any preceding claim wherein the barrier member(s) is configured to permit waste gases to exit the appliance at a rate of 100 litres per hour at a pressure of 1 psi in the cavity.

25. An ostomy appliance according any one of claims 2 to 24 wherein the apertures are created by a laser.

26. An ostomy appliance according to any preceding claim including a recusable opening to permit the cavity of the appliance to be emptied of its contents.

27. An ostomy appliance substantially as hereinbefore described with reference to and as shown in the accompanying drawings.

28. Any novel feature or novel combination of features described herein and/or in the accompanying drawings.