GB2394897A

GB2394897A - Ostomy appliance and spacing means therefor

Info

Publication number: GB2394897A
Application number: GB0223987A
Authority: GB
Inventors: Hugh K Brady; John Williams
Original assignee: ALPHA MED
Current assignee: ALPHA MED
Priority date: 2002-10-15
Filing date: 2002-10-15
Publication date: 2004-05-12
Anticipated expiration: 2022-10-15
Also published as: GB2394897B; GB0223987D0

Abstract

An ostomy appliance, an ostomy kit and a spacing means for use with an ostomy appliance. The ostomy appliance comprises a hollow bag having opposing internal surfaces and an opening for receiving a stoma. In addition, a spacing means 20 is either inserted by the user prior to use or supplied as an integral part of the ostomy appliance. The spacing means reduces the problem known as "pancaking" where the creation of a partial vacuum within the ostomy appliance causes the internal surfaces of the hollow bag to stick together. The use of the spacing means reduces the risk of pancaking and thereby reduces the possibility of leakage onto the peristomal skin of the user.

Description

- 1 - Ostomy Appliance and Spacing Means Therefor The present invention

relates to an ostomy appliance, an ostomy kit and a spacing means for an 5 ostomy appliance.

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 10 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 15 with faecal waste; and a urostomy, which is concerned i. À. 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 À. À waste material collected in an ostomy appliance or . 20 stoma bag.

In the past a problem known as "pancaking" has À occurred where the internal surfaces of the hollow bag stick together. This problem is caused by the creation of a partial vacuum within the hollow bag at 25 the time it is applied to the users abdomen. This problem has been exacerbated by the use of integral filters, which are incorporated into the majority of ostomy appliances and which allow the air inside the bag to escape, thus exacerbating the "pancaking" 30 effect. When the user of the ostomy appliance experiences a bowel movement the waste matter attempts to enter the hollow bag under gravity, but is unable to do so due to the pancaking of the internal surfaces of the hollow bag. This may lead to leakage of the 35 waste matter around the stoma and onto the peristomal skin. This in turn may cause distress to the patient, sore skin as a result of the leakage and may make it

2 - necessary to change the ostomy appliance.

It is therefore desirable to provide an ostomy appliance which reduces the risk of pancaking and as a result reduces the risk of leakage of waste matter 5 around the stoma and on the peristomal skin.

According to the present invention there is provided an ostomy appliance comprising a hollow bag having opposing internal surfaces, an opening for receiving a stoma and spacing means disposed within 10 the hollow bag to maintain the internal surfaces in spaced relationship.

A number of embodiments of the present invention will now be described by way of example with reference . to the accompanying drawings in which: 15 Figure 1 is a front elevational view of an ostomy À e.. apcliar.ce in accordance with the present invention; A.: Figure 2 is a cross-sectional side view of an À Àe ostomy appliance in accordance with the present invention; .: 20 Figures 3a and 3b show examples of spacing means À À. À for use with the present invention.

Referring to figures 1 and 2, there is shown an ostomy appliance 10 comprising a hollow bag 12 which has opposing internal surfaces 14 and 16, and an 25 opening 18 for receiving a stoma. Preferably the - hollow bag 12 is made of two distinct layers of plastic film which are heat welded at the edges to form a closed structure. In addition, a spacing means 20 is shown inside the hollow bag 12 between the 30 opposing internal surfaces 14 and 16. The spacing means.20 may be inserted by the user prior to use, or supplied as an integral part of the ostomy appliance 10. The spacing means 20 may be formed of any convenient material. Preferably the spacing means 20 is resiliently deformable to ensure maximum comfort during use. Preferably the spacing means 20 is made

- 3 of one of the following group of materials: open cell foam, closed cell foam, rubber or a suitable polymer.

However, it would be appreciated by a person skilled in the art that any three dimensional cellular 5 structure would be suitable.

Alternatively, the spacing means 20 may be made of a solid material such as, but not limited to, plastic material. Under such circumstances the spacing means 20 is preferably adapted so as to be 10 capable of flexing. Alternatively the spacing means 20 may be made of segments hinged to provide a flexible spacing means 20.

The advantages of the spacing means 20 being resiliently deformable are that the spacing means 20 i.. 15 will be easier to insert into the hollow bag 12 through the opening 18 and that the spacing means 20 . is then able to deform in use, whilst still preventing ÀÀ. pancaking, so as to be discrete and comfortable for Àe- the user.

. 20 With reference to Figures 1 and 2, it is seen ÀÀe that in one embodiment of the present invention the t... Opening 18 is located towards one end of the hollow bag 12. Preferably the spacing means 20 is located in the region between the opening 18 and said one end of 25 the hollow bag 12. Since the inflow of waste matter is under gravity this flow would be downwards from the opening 18. Positioning the bridging member above the opening 18 would therefore stop the spacing means 20 interrupting the flow of the waste material into the 30 hollow bag 12.

In order to facilitate easy insertion of the spacing means 20, the spacing means 20 may be substantially smaller than the opening 18 in the hollow bag 12. This will be of particular importance 35 if the spacing means 20 is made of a solid material and cannot otherwise be deformed sufficiently to fit through the opening 18. It is also preferable that

- 4 the spacing means 20 has at least one contact surface dimensioned so as to be smaller than the distance between the opening 18 and the end of the hollow bag 12 to enable the spacing means 20 to be placed in the 5 most advantageous position, ie. between the opening 18 and the end of the hollow bag 12.

Figures 1 and 2 depict the spacing means 20 in the shape of a cuboid. Alternatively the spacing means 20 may take any three dimensional form. For 10 example, a cylinder as shown in Figure 3b. An advantage of providing tessellating shaped spacing means 20 is that the spacing means may be cut efficiently from a larger piece of material.

À.. The depth (h) of the spacing means 20 should be .. - 15 sufficiently large to stop pancaking but sufficiently stall to ensure that the ostomy appliance 10 remains . discrete when worn under clothing.

À Àe In order to keep the spacing means 20 in position Àe i: is advantageous to supply one or both of the . 20 contact surfaces 22a and 22b of the spacing means 20 À Àe with an adhesive. Preferably this adhesive is covered À..e with a non-adhesive release layer prior to insertion to maintain maximum adhesion when the spacing means 20 is in position within the hollow bag 12. This release 25 layer is removed by the user prior to insertion of the spacing means 20 into the hollow bag 12.

To further aid adhesion the contact surfaces are preferably planar.

The ostomy appliance 10 illustrated in figure l 30 has a number of advantages over those of the prior art. Baby providing a spacing means 20, and in particular by permanently fixing the spacing means 20 to the internal surfaces 14 and 16 of the hollow bag 12, it has been found that the risk of pancaking is 35 significantly reduced, thereby reducing the possibility of leakage onto the peristomal skin of the user. By reducing the risk of leakage it is also

possible to reduce the requirement to change the ostomy appliance 10 more frequently than would otherwise be required.

It will be apparent to those skilled in the art 5 that the present invention is not limited to the shape of the hollow bag 12 used or the shape of the spacing means 20 provided. In particular, the shape of the spacing means 20 is not limited to the examples illustrated in the figures.

10 Likewise, although the present invention has been described with reference to a one piece ostomy appliance 10, it will be apparent to those skilled in the art that the present invention is not limited to À.. such appliances. Indeed, two part or multi part e. e. 15 ostomy appliances may also benefit from the present À 1nventlon. À À. À Àe À. À À.. À.e

Claims

- 6 - Claims

1. An ostomy appliance comprising: a hollow bag having opposing internal surfaces and 5 defining an opening for receiving a stoma; and spacing means disposed within said bag to maintain said surfaces in spaced relationship.

2. An ostomy appliance in accordance with claim 1 10 wherein said spacing means is formed integrally with said hollow bag.

3. An ostomy appliance in accordance with claim 1 :'' wherein said bag is formed from a first material and ,. I. 15 said spacing means is formed from a second material different from said first material.

À . ,

4. An ostomy appliance in accordance with any preceding claim wherein said spacing means is : 20 resiliently deformable.

À '

5. An ostomy appliance in accordance with any preceding claim wherein said spacing means is formed from a material selected from the list comprising: a 25 closed cell foam, an open cell foam, rubber or a polymer.

6. An ostomy appliance in accordance with any preceding claim wherein said opening is located towards 30 one end of said hollow bag and said spacing means is disposed in a region between said opening and said one end. 7. An ostomy appliance in accordance with any 35 preceding claim wherein said ostomy appliance comprises a filter.

7 -

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

9. An ostomy kit comprising: 5 a hollow bag having opposing internal surfaces and defining an opening for receiving a stoma; and spacing means for use in maintaining said surfaces in spaced relationship.

10 10. An ostomy kit in accordance with claim 9 wherein said spacing means is resiliently deformable.

11. An ostomy kit in accordance with claim 9 or claim :'. 10 wherein said spacing means is formed from a material .. I. 15 selected from the list comprising: a closed cell foam, an open cell foam, rubber or a polymer.

c Àe

12. An ostomy kit in accordance with any of claims 9 to 11 wherein said opening is located towards one end of 9.: 20 said hollow bag.

À:

13. An ostomy kit in accordance with any of claims 9 to 12 wherein said spacing means defines a contact surface which in use contacts at least one of said 25 internal surfaces of said hollow bag, the contact surface being provided with adhesive.

14. An ostomy kit in accordance with any of claims 9 to 13, wherein said spacing means defines two mutually 30 opposed contact surfaces at least one of which is provided with adhesive.

15. An ostomy kit in accordance with claim 13 or claim 14 wherein the adhesive is covered with a release layer 35 prior to use.

16. An ostomy kit in accordance with any of claims

- 8 - 9 to IS wherein said hollow bag comprises a filter.

17. An ostomy kit substantially as herein described with reference to the accompanying drawings.

18. A spacing means for use with an ostomy appliance comprising a hollow bag member having opposing internal surfaces and defining an opening for receiving a stoma, the spacing means, in use, serving to maintain said 10 surfaces in spaced relationship.

19. A spacing means in accordance with claim 18 wherein said spacing means is resiliently deformable.

À:'. .. 15

20. A spacing means in accordance with claim 18 or claim 19 wherein said spacing means is formed from a : material selected from the list comprising: a closed À. cell foam, an open cell foam, rubber or a polymer.

À 20

21. A spacing means in accordance with any of claims 18 to 20, wherein said spacing means defines a contact surface which in use contacts at least one of said internal surfaces of said hollow bag, the contact surface being provided with adhesive.

22. A spacing means in accordance with any of claims 18 to 21 wherein said spacing means defines two mutually opposed contact surfaces at least one of which is provided with adhesive.

23. A spacing means in accordance with claim 21 or claim 22 wherein said adhesive is covered with a release layer prior to use.

35

24. A spacing means for use with an ostomy appliance, the spacing means being substantially as herein described with reference to the accompanying drawings.