This invention relates to a device for preventing noise production from a stoma. The invention is particularly applicable to use with colostomies and ileostomies.

A stoma is an opening made in the digestive tract often in response to an illness which impairs or alters the function of the digestive tract, for example colon cancer. The stoma may either be temporary or permanent. The presence of a stoma means that bowel contents are diverted from the normal route through the digestive tract and pass out of the body through the stoma into a bag where they are collected.

Figure 1 illustrates a conventional colostomy and colostomy bag. In a conventional arrangement a locking ring 10 having an adhesive backing 12 is attached to the patient's body with the locking ring 10 surrounding the stoma 14. A colostomy bag 16 has a complementary ring 18 which enables the colostomy bag 16 to be attached to the first ring 10 and hence to the patient. This configuration results in an uninterrupted passage between the stoma 14 and the colostomy bag 16 allowing stools to pass from the stoma 14 to the colostomy bag 16.

Once the stoma is in place, however, gas created by the digestion of food builds up behind the stoma and when the pressure is too great for the stoma opening to prevent its release, the gas escapes through the stoma in a sequential series of closely linked gas bubbles, causing the stoma to rapidly open and close. The rapid opening and closing of the stoma creates an audible noise. This flatulence can become a problem as the user has no way of

controlling the escape of gas from the stoma or the noise associated with this. Additionally, the noise can often cause embarrassment to a person having a colostomy.

Much attention has been paid to the reduction of smells associated with colostomies, for example by introducing carbon into the bag, and also reducing the noise made by the colostomy bag itself, for example by insulating all or a part of the colostomy bag. Less attention has been paid to reducing the noise caused by gas passing out of the stoma although this can be equally as disturbing to the patient.

US Patent 4,406,657 describes a method for reducing the noise resulting from flatulence. It describes an oblong device made of porous material which is inserted into the colon using the stoma. The device has a hole which acts to keep the stoma open so that gases can pass through the device and the stoma without any pressure build-up and consequent noise production. However, whenever a stool is passed the device is pushed out of the stoma and into the colostomy bag. This results in a number of disadvantages, for example, after a stool has been passed the device is no longer in the stoma and therefore, the patient is susceptible to gas build up and consequent noises discussed above. Alternatively, it is suggested that the device ejected into the bag can be reinserted by hand into the end portion of the intestine; however, this may not always be convenient.

What is needed therefore, is an improved method for reducing the disturbance caused by the noise when gas exits the stoma.

According to one aspect of the present invention there is provided a device adapted to interrupt the seal of a stoma, comprising a body adapted to pass through the stoma and an

anchor attached to the body, wherein the device is arranged such that the body of the device constantly penetrates the stoma.

Preferably, the anchor is positioned external to the stoma. More preferably, the anchor comprises an anchor ring adapted to attach to a colostomy bag. Preferably the anchor ring is also adapted to attach to a ring attached to a patient. Alternatively, the anchor may be integral to the colostomy bag.

The device may be made from biocompatible material. Preferably the biocompatible material is polypropylene or polyethylene.

According to a second embodiment of the present invention there is provided a method for reducing noise produced by a stoma comprising the steps of preventing complete closure of the stoma by placing a device through the stoma and anchoring the device in place.

According to a further embodiment of the present invention there is provided an anchor for securing the body of a device in place comprising an anchor ring adapted to attach to a ring attached to a patient.

Embodiments of the invention will now be described, by way of example, and with reference to the drawings in which:

Figure 1 illustrates a conventional colostomy bag configuration;

Figure 2 illustrates an interference device having an external anchor;

Figure 3 illustrates the interference device and external anchor; and Figure 4 illustrates an interference device with an internal anchor.

According to one embodiment there is an interrupting device arranged to pass through the stoma to interfere with the closing of the stoma. The prevention of the complete closure of the stoma allows a constant flow of gas to escape from the stoma preventing any gas build- up. The device may be made from any material such as a non-toxic plastic or non-reactive metal which is arranged to pass through the stoma. However, preferably, the interrupting device is made from polypropylene or polyethelene and more preferably it is made from a biocompatible material used for an implantable/long-term surface dwelling device.

The anchor is a ring 20 intermediate to the locking ring 10 attached to the patient and the complementary ring 18 attached to the colostomy bag 16. The anchor has at least one prong 22 as shown in Figure 2. The intermediate ring 20 is configured so that it attaches to the locking ring 10 attached to the adhesive backing 12 with the prong 22 directed towards the stoma 14 and penetrating through the end of the stoma 14 as shown in Figure 3. The complementary ring 18 attached to the colostomy bag 16 may then attach to the intermediate ring 20 allowing passage of any stools from the stoma 14 to the colostomy bag 16 without the device 24 being displaced. Preferably the outer aspect of the intermediate ring 20 duplicates the outer surface of the locking ring 10 allowing a conventional complementary ring 18 for a colostomy bag to attach to the intermediate ring 20 without modification.

The prong 22 is attached at one end to the intermediate ring 20. Preferably the prong 22 is made of biocompatible implantantable material. Additionally, there are preferably multiple prongs 22. The prongs 22 may be separate or connected together where they penetrate the stoma. By having multiple prongs 22 the prongs 22 can co-operate holding the stoma's

ends apart from each other. The distal ends of prongs 22 are preferably flattened in order to more effectively hold the ends of the stoma apart.

In this way it can be seen that the interrupting device 24 prevents complete closure of the stoma 14 allowing gas to slowly and continuously leak out from the stoma 14 and thereby preventing the noise commonly associated with a colostomy. Furthermore, the presence of the intermediate ring 20 means that the interrupting device 24 is not displaced and therefore does not need to be replaced after a stool has been passed. Additionally, by anchoring the device 24 in this matter the device 24 is readily replaceable when it has reached the end of its lifetime.

In alternative arrangements the prongs may be integral with the locking ring 10, attached to the adhesive or backing 12, or the second ring 18 attached to the colostomy bag 16.

In a second embodiment the interrupting device 24 is attached to the mucosal wall 26 of the colon by endoscope and/or any other means using an internal anchor 28 as shown in Figure 4. The device 24 may be attached by suturing the device 24 to the wall 26 of the colon. A prong 22 or number of prongs 22 anchored in this manner may then pass from the inside of the stoma 14 through the stoma to the inside of the colostomy bag 16 This prevents complete closure of the stoma 14 and hence the production of noises.