BACKGROUND TO THE INVENTION Most existing colostomy product comprise a two-part apparatus having a cover plate which has an adhesive surface and is stuck on to the abdomen of a stoma patient, and a transparent and plastic pocket, which clips onto the cover plate. The cover plate (wafer) has a central aperture which fits over the stoma. This aperture has to be cut to an appropriate size by the patient. A plastic ring-shaped clip arrangement is mounted on the non-adhesive side of the wafer. This matches a corresponding ring which is integral with the pocket. By this means the pocket is clipped into position and waste matter passes into the pocket.

In another existing form, the pocket and cover plate are a single unit which is stuck onto the skin and must be pulled off again once it is full. A fresh unit must then be stuck on. The pocket is open at the remote end and sealed with a clip.

Both these products hang on to the patient's body without any additional support.

For many patients neither of these arrangements is suitable for one or more of the following reasons :- a) The skin of the abdomen is irritated or infected by the adhesive substances used, the acid from the stomach or the weight of the apparatus pulling on the skin. b) The pocket is easily dislodged.

c) The clip for sealing the remote end of the pocket easily opens with disastrous consequences for the user. d) The pocket is unsightly and may cause psychological problems. e) The product has an unpleasant smell. f) Draining and washing the pocket is unpleasant. g) The wafer often crumbles or breaks and sometimes comes loose. h) A bump on the abdomen may cause the wafer to cut the stoma or damage the skin. i) In cutting out the right sized hole for the stoma, the resulting sharp edge also damages the stoma. j) Removal of the wafer (which is glued on) is often painful and damages the skin. k) The pocket is inclined to stick to the skin of the abdomen, especially on hot days.

1) The existing products are very expensive. m) With the existing colostomy products, a patient is dependant on a range of very expensive medications some of which are not always available.

The colostomy apparatus according to the present invention seeks to overcome all or at least most of the abovementioned disadvantages.

SUMMARY OF THE INVENTION According to the invention a colostomy apparatus for use in connection with a stoma is characterised by a combination of the following elements- : a) an absorbent pad having a centrally located hole manufactured to accommodate the stoma of an individual and which pad makes contact with the skin surrounding the stoma ;

b) a cup shaped stoma seal having a centrally located hole at its base manufactured to accommodate the stoma of an individual and a external sealing flange at its midsection, c) a base plate which comprises a ring shaped threaded collar having an inwardly projecting flange at the far end of the thread and a flexible skirt projecting out from the collar; d) a utricle having a neck and forming a reservoir for waste matter from the stoma and; e) a utricular nut for sealing the utricle and having an external thread corresponding to the thread of the collar in the base plate ; the arrangement being such that in use the cup shaped stoma seal is placed in the neck of the utricle and the reservoir section is fed through the utricular nut so that the leading edge of the utricular nut seals the neck of the utricle against the flange on the cup shaped stoma seal and the utricular nut may be screwed into the collar of the base plate to press the flange of the cup shaped stoma seal against the flange of the collar in the base plate.

Further a colostomy apparatus according to the invention includes an abdominal belt provided with a pocket for holding the apparatus and hiding the utricle.

Further a colostomy apparatus according to the invention includes a pocket formed by a flap which can be opened and closed.

Further a colostomy apparatus according to the invention is provided with a belt in two sections which may be joined by Velcro strips on the ends of both sections.

Further a colostomy apparatus according to the invention is provided with an absorbent pad which has a waterproof plastic backing facing the base plate and a non-sticking layer which makes contact with the skin of the patient around the stoma.

Further a colostomy apparatus according to the invention is provided with a cup shaped stoma seal manufactured from a flexible plastic.

Further a colostomy apparatus according to the invention has a base plate in which the flexible skirt is manufactured from a body-friendly monprene compound or medical rubber compound.

Further a colostomy apparatus according to the invention has a base plate in which the collar is manufactured from Polypropylene, nylon or other suitable compounds.

Further a colostomy apparatus according to the invention is provided with a base plate in which the skirt and collar are manufactured to form a unit by using an over-moulding technique.

Further a colostomy apparatus according to the invention is provided with a utricle which is opaque.

Further a colostomy apparatus according to the invention is provided with a utricle having a gas discharge passage and a clip for closing the discharge passage.

Further a colostomy apparatus according to the invention is provided with a utricle made from a strong elastic or rubber compound which is adapted to withstand hard knocks.

Further a colostomy apparatus according to the invention is provided with a utriclar nut made from Polypropylene, nylon or other suitable compounds Further a colostomy apparatus according to the invention is attachable to a patient other than by gluing or sticking.

Further a colostomy apparatus according to the invention allows a patient to use medication around the stoma while the apparatus is in use.

BRIEF DESCRIPTION OF DRAWINGS FIGURE 1 Is an exploded perspective view, showing the component parts, namely a stoma screen (1), a base plate (2), a cup shaped stoma seal (5), a utricular nut (4), utricle (6), bronchial clip (7), (stoma belt (11) not shown).

FIGURE 2 Is a perspective view of the assembled apparatus but without the stoma screen (1), base plate (2) and stoma belt (11).

FIGURE 3 Is a perspective view of an assembled apparatus showing the base plate (2), the utricular nut (4) utricle (6) and bronchial clip (7), (stoma screen (1), cup shaped stoma seal (5), and stoma belt (11) not shown).

FIGURE 4 Is a plan view of part of the stoma belt (11) with pocket closed.

FIGURE 4A Is a perspective view of part of the stoma belt 11 with pocket closed.

FIGURE 5 Is a plan view of a part of the stoma belt (11) with pocket open.

FIGURE 5A Is a perspective view of a part of the stoma belt (11) with pocket open.

FIGURE 6 Is a front view showing the complete colostomy apparatus including stoma belt (11) in position on a patient with the pocket open.

FIGURE 7 Is a front view showing the complete colostomy apparatus including stoma belt (11) in position on a patient with the pocket closed.

FIGURE 8 Is a cross-section through the assembled base plate (2), cup shaped stoma seal (5), utricular nut (4), and part of the utricle (6).

BEST MODE OF CARRYING OUT THE INVENTION As can be seen in Figures 1, 2,3 and 8 a colostomy apparatus according to the invention comprises the following parts:- 1. A stoma screen (1); 2. A base plate (2) having an internally threaded collar (3) with a flexible skirt (2A); 3. A cup shaped stoma seal (5); 4. An utricle (6) having a neck (19), a gas discharge passage (10) and a bronchial clip (7) for sealing off the discharge passage (10); 5. An utricular nut (4) having an external thread to match the internal thread of collar (3) in the base plate (2).

In addition to the above there is provided a stoma belt (11) which is shown in Figures 4,4A, 5 and 5A.

A detailed description of each of the above components follows :- 1. STOMA SCREEN (1).

The stoma screen (1) is a sterile absorbent pad which makes contact with the skin of the abdomen and is provided with a hole (17) which is made large enough to fit neatly around the stoma. The stoma screen (1) absorbs any stomach acid which may leak out of the stoma and also any perspiration which may form beneath the base plate (2). The stoma screen 1 is oval-shaped and is slightly larger than the flexible skirt (2A) of the base plate (2). Ideally it projects about 3-4 mm beyond all the edges of the flexible skirt (2A).

Micropore or Propore (or any other suitable surgical plaster) is used to stick the base plate (2) and stoma screen (1) to the abdomen of a stoma patient.

2. BASE PLATE (2).

The flexible skirt (2A) is manufactured from a body-friendly Monprene or a medical rubber compound. The collar (3) is manufactured from suitably hardened Polypropylene, nylon or other suitable compound. It is provided with an internal thread and a flange (18).

3. CUP SHAPED STOMA SEAL (5).

The cup shaped stoma seal (5) is also manufactured from a body-friendly plastic or PVC product with the required density. At the one end of the cup shaped stoma seal there is a hole (5A) which is manufactured to fit the size of the individual patient's stoma. The cup shaped stoma seal (5) presses down on the stoma screen (1) and makes a seal right around the stoma so that no waste matter can penetrate between the base plate (2) and the stoma screen (1). At the same time the skin is protected against stomach acid.

4. UTRICLE 6.

The utricle (6) is an opaque plastic bag having a neck (19), a gas discharge passage (10), and a bronchial clip (7). The utricle (6) is disposable and not intended for reuse. It is designed to have a relatively flat cross-section when blown up or extended. It is thus not spherical and noticeable under the clothing of the user. In use the gas discharge passage (10) will be kept closed by the bronchial clip (7) (see Figure 2). Should the need arise the gas may be released from the utricle (6) by opening the bronchial clip (7) and allowing the gas to escape. When the utricle (6) is full, it together with the cup shaped stoma seal (5) is disposed of. The bronchial clip (7) however is retained for further use.

The utricle (6) may be manufactured in varying strengths and thicknesses to accommodate users with an active lifestyle.

5. UTRICULAR NUT (4) The utricular nut (4) is used to screw the neck of the utricle (6) up against the flange (20) of the cup shaped stoma seal (5) which in turn makes a seal against flange (18) of the collar (3) of the base plate (2). The utricular nut (4) has a sharp leading ridge to make a seal against the flange (20) of the cup shaped stoma seal (5). This is more fully described below. By means of the utricular nut (4), the utricle (6) is sealed so that it is completely water tight and gas tight. The utricle is designed to provide a firm grip on the utricular nut (4).

The apparatus described thus far is used in conjunction with a stoma belt. This comprises a front section (11) and a back section not shown. It's function can be readily understood by referring to Figures 4,4A, 5,5 A, 6 and 7. Both sections are made from a strong linen having stitching (14). The front section (11) is provided with a hole (15) which is located over the stoma. A flap (12) and Velcro fastening (13) forms a pocket which can be opened and closed.

Velcro fastening (13) is also sewn on to the ends of the front section (11) and the back section.

By making the belt in two sections, it is possible to make provision for different body shapes and different positions of the stoma. The back section is additionally designed to provide support to the back. The hard Velcro is fitted on the ends of the back section with the Velcro facing to the outside and the soft Velcro is fitted to the front section and faces to the inside.

METHOD OF USING THE COLOSTOMY APPARATUS The way in which a patient will use the colostomy apparatus will now be described.

Firstly the cup shaped stoma seal (5) is placed in the neck (19) of the utricle (6). The spherical part of the cup shaped stoma seal (5) must face outwards from the utricle and will eventually form a seal around the stoma by pressing on the stoma screen (1). The cup shaped stoma seal (5) is pressed into the neck (19) of the utricle (6) until it is just above the gas discharge passage (10). Now the lower part of the utricle (6) is fed through the utricular nut (4) which is pushed in so that it presses against the flange (20) of the cup shaped stoma seal (5). The neck (19) of the utricle (6) is neatly cut away just above the flange (20) of the cup shaped stoma seal (5) using a pair of scissors. Thereafter the utricular nut (4) with the

cup shaped stoma seal (5) and utricle (6) is firmly screwed into the collar (3) of the base plate (2) (as can best be seen in Figure 8). The bronchial clip (7) is applied by inserting the gas discharge passage (10) through a slot (7A) (Figure 2) in the bronchial clip (7) bending it back on itself and closing the clip (7).

It is important at this stage to test utricle (6) for leaks by placing the mouth over the stoma seal (5) and blowing into the utricle (6). Should a leak be detected in the utricle (6), it must be replaced with another one.

Now the assembled unit with base plate (2) is placed downwards on a towel and 48 mm Micropore or Propore stuck around the edges and neatly trimmed. Preferably Porpore is used as it is waterproof. Thereafter the stoma screen (1) is positioned on the base plate (2) so that the hole (17) in the stoma screen (1) corresponds with the hole (SA) in the cup shaped stoma seal (5). The edges of the stoma screen (1) extend slightly beyond the edges of the flexible skirt (2A) as it is made slightly larger than the skirt (2A). The Micropore or Propore can then be pressed on to the stoma screen (1) to hold it in position. The colostomy apparatus is now ready for use. The skin of the abdomen around the stoma must be thoroughly cleaned preferably using surgical spirit. The patient has to pull in the stomach and the stoma screen (1) with assembled apparatus and Propore or Micropore placed carefully in position around the stoma. Once it is correctly positioned and comfortable and with the stomach still pulled in, the Micropore or Propore is firmly pressed down on the skin until it holds.

Thereafter the stomach is slowly released and the patient makes sure that the device is fitting correctly and comfortably. If not, the Micropore or Propore can be lifted and adjustments made. Thereafter the stoma belt (11) is put on with the utricle (6) being passed through hole (15) in the pocket of the belt and held in position by flap (12). The stoma belt (11) is provided with Velcro (13) which allows the pocket to be opened and closed. A back section of the belt (not illustrated) also has Velcro ends and allows for variations in body shapes.

The back section of the stoma belt (11) also offers back support.

RELEASE OF GAS Should it be necessary to release gas from the utricle (6), the flap (12) is opened and the bronchial clip (7) unfastened. The gas discharge passage (10) is nipped between two fingers and pointed upwards while gently pressing the utricle (6). After releasing the gas, the forward part of the gas discharge passage (10) (i. e. beyond the clip (7)) is pulled through a piece of paper towel or toilet paper to remove any drops of liquid which may be there.

REPLACEMENT OF UTRICLE (6) When it becomes necessary to replace the utricle, the following steps are : 1. Have a shopping bag ready.

2. Remove or fold back any clothing that may be in the way.

3. Open the pocket on the belt (11) (see Figure 6).

4. Have a new apparatus as shown in Figure 2 assembled and ready.

5. Screw out the full utricle (6), clean the base plate (2A) with toilet paper, and screw the new assembly in.

6. Remove the bronchial clip (7) and utricular nut (4), and place the utricle (6) and cup shaped stoma seal (5) in the shopping bag and dispose of it.

BATHING AND SHOWERING Before showering or bathing, only the stoma belt (11) is removed and showering or bathing done with the apparatus in position. Thereafter the usual replacement procedure is followed.

The patient must make sure that the body is thoroughly cleaned and dried and soap removed where the Micropore or Propore must be stuck. Should the stoma feel inflamed or bleed excessively, normally due to an incorrect diet, the stoma itself should be washed with Stomawash which immediately stops bleeding and irritation. If the stoma needs to be treated the patient can him or herself apply ointment or powder to the stoma.

INDUSTRIAL APPLICATION A colostomy apparatus as previously described has application in the field of medicine.

It is used as an appendage for patients who have undergone a colostomy and have a stoma in the abdominal wall. It is used for the purpose of dealing with solid, gaseous and liquid waste matter from the digestive tract which passes out of the body of the patient.