In connection with surgery for a number of diseases in the gastrointestinal tract a consequence is, in many cases, that the colon, the ileum or the urethra has been exposed surgically and the patient is left with an abdominal stoma. Such artificial intestinal openings or fistulae cannot be controlled at will and are therefore of necessity incontinent and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accom- modating the stoma. Such appliances may be two-piece or one-piece appliances. In both types of appliances, a body side member is attached to the wearer's abdomen, and optionally a receiving member or bag is attached to the body side ostomy member for receiving exudates from the ostomy in case of a two-piece appliance.

In many instances patients having had a surgery resulting in the formation of a stoma, an accompanying condition is formation of a hernia which may complicate the bandaging of the stoma and even require further surgery. Even if further surgery is carried out there is a considerable risk of a permanent condition which cannot be alleviated.

In such cases, the patient will have to rely on a additional hernia support for a mechanical reposition of the hernia for providing a plane surface around the stoma for application of a collecting appliance in order to secure a proper adher- ence and sealing. Such hernia support is commonly known and may e. g. be in the form of a belt of e. g. of leather with buckles, or in the form of a support

garment made from an elastic fabric being able to apply a sufficient pressure around the stoma.

In the case of a colostomy and in case the ostomist is normally irrigating, a minor cap or collecting bag may be used which enables the use of a firm hernia belt or tight compression briefs for providing a sufficient pressure around the stoma. For ileostomists or urostomists this procedure is not practicable due to the constant rather high output from the ileum or bladder and for urostomists it may be critical to provide a free flow from the stoma in order to prevent a build-up of a back pressure which may destroy the kidneys.

In such cases, it is highly desirable or mandatory to give access to a larger collecting volume which means that the collecting bag itself will have to be situated outside the pressure establishing belt or briefs and that a passageway through the same has to be established.

Determination of the site for placing the stoma is normally carried out prior to the operation after observing the patient in different postures, e. g. sitting, standing and bending over, finding the less critical area. WO 00/67683 discloses a device for use in the determination and marking of the optimum position of a stoma to be for the patient in question.

As the placing of a stoma is not standardised but depends on the condition and the topography of the abdominal area of the patient, it is not possible to provide a simple selection of standard hernia supports fitting the majority of patients. The passageways must be tailored according to the actual conditions of the individual patient.

2. Description of the Related Art DK Patent Application No. PA 1999 01559 discloses a stomal hernial support compression garment in the form of a pair of compression trousers. The trousers are tailored by determining the dimensions of the patient and the localisation of the stoma for producing a pair of trousers specifically for the patient in question for ensuring a specific compression force. The manufacture of such a hernial

support is laborious and expensive as the whole support is made specifically for each patient.

No devices for an easy localisation and marking of a hole for receiving a stoma for tailoring a standard hernia support is disclosed and there is a need for such device in order to enable a better offer of tailoring hernia supports for improving the security against leakage and the quality of life for the patient after this kind of surgery.

The present invention provides a simple device for an easy determination and marking of the site for a customised hole in a standard hernia support for enabling a free flow of effluents from a stoma to pass the hernia support without compromising the hernia supporting properties thereof.

SUMMARY OF THE INVENTION The present invention relates to a device for locating and marking the optimum position of the centre of a hole for receiving a stoma in a stomal hernia support.

Furthermore, the invention relates to a set consisting essentially of a device for locating and marking the optimum position of the centre of a hole for receiving a stoma in a stomal hernia support and an adhesive wafer having a hole corre- sponding to the inner diameter of the flange.

Furthermore, the invention relates to methods of locating and marking the centre of a hole for tailoring a stomal hernia support to a specific user.

Brief Description of the Drawings The invention is disclosed more in detail with reference to the drawings in which Fig. 1 shows a top view of an embodiment of a device of the invention, Fig. 2 shows a sectional view of the embodiment shown in Fig. 1, Fig. 3 shows a top view of another embodiment of a device of the invention, Fig. 4 shows a sectional view of the embodiment shown in Fig. 3, Fig. 5 shows a top view of a further embodiment of a device of the invention, and

Fig. 6 shows a sectional view of the embodiment shown in Fig. 5.

Detailed Description of the Present Invention The invention relates to a device for locating and marking the optimum position of the centre of a hole for receiving a stoma in a stomal hernia support, said device being in the form of a dome-like structure having a flange-like part at the rim and an indication of the centre of the top of the dome wherein the indication is detectable through the material of the hernial support and wherein the dome has a cavity volume capable of accommodating the stoma in question.

Thus, the present invention provides a simple device for an easy determination and reliable marking of the site for providing a customised hole in a standard hernia support for enabling a free flow of effluents from a stoma to pass the hernia support without compromising the hernia supporting properties thereof.

Marking may be made by pressing the material against the device of the inven- tion and detecting and marking the centre using e. g. a pen, pencil, knife or stiletto leaving a mark or hole at the intended place. It is preferred that the indica- tion of the centre of the top of the dome is visible for facilitating the detection.

The indication may also be detected by feeling or using a tracing instrument, e. g. based on utilisation of magnetism or metal detection.

In one simple embodiment of the invention, the indication is in the form of a point or spike protruding at the top of the dome which may easily be used for marking by simply pressing the support against the spike leaving a mark or a hole at the intended place.

In another embodiment of the invention, the indication is in the form of an inden- tation at the top of the dome which may function as a guide when pressing a pen, pencil, knife or stiletto against the support for leaving a mark or a hole at the intended place.

The device is preferably essentially hemispheric.

For an easier retrieval of the centre of the hole-to-be, it is preferred that the indentation is centrally located at the top of the dome and even more preferred that the indentation is surrounded by a rim protruding from the surface of the dome-like structure which will be more easily detected visually.

In another preferred embodiment of the invention, the top part of the dome-like structure is provided with a relatively flat area indicating the size of the hole to be cut out in the hernia support. This enables a simple making of holes in especially elastic support materials as the borders of the hole may easily be indicated while the support is in a stretched state covering the stoma facilitating the cutting of the hole using e. g. a knife or a pair of scissors.

In one embodiment, the device of the invention further comprises an adhesive wafer secured to the flange which wafer has a hole for receiving a stoma. Such device may be placed in a very simple manner on the abdomen in a similar manner as an ostomy body side member when using the device.

The invention also relates to a set consisting essentially of a device for locating and marking the optimum position of the centre of a hole for receiving a stoma in a stomal hernia support, said device being in the form of a dome-like structure having a flange-like part at the rim and an indication of the centre of the top of the dome, wherein the indication is detectable through the material of the hernial support and wherein the dome has a cavity volume capable of accommodating the stoma in question, and an adhesive wafer having a hole corresponding to the inner diameter of the flange. This embodiment has the advantage that the dome- like part of the device needs not be disposed when the service time of the adhesive wafer is spent due to disappearing of the adhesive properties due to "killing"by dust or loose skin parts or similar. The adhesive wafer may suitably be a conventional body side member of a two-piece ostomy appliance. In such case, the dome-like structure may be provided with coupling means known per se for ostomy appliances such as means matching with conventional coupling rings. In this case, the device of the invention may be used together with the users own body side member then serving as one part of the set.

Furthermore, the invention relates to a method of locating and marking the centre of a hole for tailoring a stomal hernia support to a specific user comprising locating a device being in the form of a dome-like structure having a flange-like part at the rim and further comprising an adhesive wafer secured to the flange which wafer has a hole for receiving a stoma and an indication of the centre of the top of the dome, wherein the indication is detectable through the material of the hernial support and wherein the dome has a cavity volume capable of accommodating the stoma in question, in such a manner that the adhesive wafer supports at and adheres to the skin around the stoma, applying the stomal hernia support and marking on the support the localisation of the indentation, removing the hernia support and then cutting a suitable hole for receiving the stoma, said hole having the centre coinciding with the mark.

Still further, the invention relates to a method of locating and marking the centre of a hole for tailoring a stomal hernia support to a specific user comprising locat- ing a device being in the form of a dome-like structure having a flange-like part at the rim and an indication of the centre of the top of the dome, wherein the indica- tion is detectable through the material of the hernial support and wherein the dome has a cavity volume capable of accommodating the stoma in question, in such a manner that the flange supports at the skin around the stoma, locating an adhesive wafer having a hole corresponding to the inner diameter of the flange in such a manner that it adheres to the surface of the flange facing away from the user and, at the same time adhering to the skin surrounding the device, applying the stomal hernia support and marking on the support the localisation of the indentation, removing the hernia support and then cutting a suitable hole for receiving the stoma, said hole having the centre coinciding with the mark.

The latter method may be carried out somewhat differently in case of a dome-like structure having coupling means known per se for ostomy appliances. In this case the dome-like structure is secured to the coupling means of the ostomy body side member already placed on the skin around the stoma in the same manner as a collecting bag.

It is also contemplated and considered an embodiment of the invention that the locating and marking the centre of a hole for tailoring a stomal hernia support to a specific user may be carried out using a marker such as a spike or more blunt projection protruding from the surface of the dome-like structure which marker may be detected automatically and transferred electronically and used in the production of a tailored stomal hernia support in a manner analogous to the method for manufacturing breast prostheses as disclosed in WO 99/25536.

Description of the Preferred Embodiments The invention is now explained more in detail with reference to the drawings showing preferred embodiments of the invention.

Reference is made to Fig. 1 and 2 which show a device of the invention for locat- ing and marking the optimum position of the centre of a hole for receiving a stoma in a stomal hernia support, said device consisting essentially of an adhesive wafer 1 for adhering to the user's abdomen, a relatively stiff dome-like structure 2 having a flange-like part 3 at the rim and an indentation 4 at the top of the dome. The adhesive wafer has a release liner 5 protecting the surface to be in contact with the skin which release liner is removed before applying the siting device. Furthermore, the wafer comprises a hole 6 for accommodating a stoma when using the device which hole may be enlarged in a manner known per se such as cutting using a knife or a pair of scissors. This embodiment of a device of the invention for locating and marking the optimum position of the centre of a hole in a stomal hernia support for receiving a stoma may be compared to a one-piece ostomy appliance in which the collecting bag has been substituted by a dome-like structure. In use, the device of the invention is adapted to the stoma in question and placed in an analogous manner like an ostomy appliance, and the stomal hernia support is localised in the intended place, and the centre of the hole to be made is marked using e. g. a pen, pencil, knife or stiletto leaving a mark or hole at the intended place during which the indentation 4 functions as a guide. Then, a hole may be made in the support in a manner known per se using e. g. a knife or a pair of scissors. The hole should have a size allowing the

accommodation of the stoma and also for the collecting bag to stretch through the hole in order to collect the effluents from the stoma.

Figures 3 and 4 show another embodiment of a device of the invention, in the form of a separate and relatively stiff dome-like structure 2 having a flange-like part 3 at the rim and an indentation 4 at the top of the dome. In this embodiment, the indentation 4 is surrounded by a rim 7 protruding from the surface of the dome which facilitates the localisation of the indentation through a stomal hernia support. This embodiment of the device of the invention may be secured to the user's abdomen using a conventional ostomy body side member having a flange 8 for adhesive coupling to a collecting bag, the flange 3 being located between the user's skin and the adhesive surface 9 of the body side member. The diame- ter of the dome-like structure and the hole 10 of the body side member should be adapted so that the rim 3 stretches under the adhesive surface.

Figures 5 and 6 show a further embodiment of a device of the invention for locat- ing and marking the optimum position of the centre of a hole for receiving a stoma in a stomal hernia support, said device consisting essentially of an adhesive wafer 1 for adhering to the user's abdomen, a relatively stiff dome-like structure 12 having a flange-like part 3 at the rim and a protruding spike 8 at the top of the dome. The adhesive wafer has a release liner 5 protecting the surface to be in contact with the skin which release liner is removed before applying the siting device. Furthermore, the wafer comprises a hole 6 for accommodating a stoma when using the device which hole may be enlarged in a manner known per se such as cutting using a knife or a pair of scissors. In this embodiment, the top part of the dome-like structure is provided with a relatively flat area 11 having a periphery 13 indicating the size of the hole to be cut out in the hernia support.

This embodiment of a device of the invention may also be compared to a one-piece ostomy appliance in which the collecting bag has been substituted by a dome-like structure as the embodiment shown in Figs. 1 and 2. In use, this embodiment of a device of the invention is adapted to the stoma in question and placed in an analogous manner like an ostomy appliance, and the stomal hernia support is localised in the intended place, and the centre of the hole to be made

is marked by pressing the support against the spike 8 leaving a mark or hole at the intended place. Alternatively, the centre may be marked by contacting the support covering the protruding spike with a printing pad known per se leaving a coloured spot on the protruding part of the support. Then, a hole may be made as discussed above.

An adhesive wafer for adhering to the user's abdomen and a release liner may be made from any suitable material known per se and used in the conventional manufacture of ostomy appliances. The dome-like structure may be made from any suitable material being compatible with the adhesive wafers and may e. g. be made from a polyolefin such as polyethylene or polypropylene of a PVC material or a copolymer such as EVA. In a preferred embodiment, the dome-like structure is made from a transparent material such as polymethyl methacrylate which allows for watching the stomal area during the marking process. The dome-like structure may be made by any suitable manner known per se such as vacuum forming or injection moulding.