EP1610736A2

EP1610736A2 - An ostomy appliance

Info

Publication number: EP1610736A2
Application number: EP04723521A
Authority: EP
Inventors: Danuta Ciok; Esben Stroebech
Original assignee: Coloplast AS
Current assignee: Coloplast AS
Priority date: 2003-03-27
Filing date: 2004-03-26
Publication date: 2006-01-04
Also published as: WO2004084778A3; WO2004084778A2

Abstract

An ostomy appliance comprising a front wall (2) and a rear wall (3) of flexible material forming a bag, said rear wall having an opening (4) for receiving a stoma (12), and said rear wall (3) also being provided with an adhesive wafer (5) for securing the appliance to a user’s skin, said wafer (5) having a first hole (6) being aligned with the opening (4) for receiving the stoma (12), wherein the opening (4) has an edge (7,7) being secured to the surface of the adhesive wafer (5) facing away from the user in an attachment zone surrounding the hole (6) of the wafer, said ostomy appliance further comprising a sealing member (13) having a second hole (14) for receiving the stoma (12), wherein the sealing member has a flange (15) projecting from an outer rim thereof, said flange (15) having an outer diameter greater than the diameter of the first hole (6), and said flange (15) comprising a skin-friendly adhesive at a first surface to be placed on the abdomen of an ostomate, and said flange (15) comprising a second surface being capable of adhering to the adhesive at the surface of the wafer (5) to be secured to the user’s skin enables the use of a sealing member together wit one-piece ostomy appliance.

Description

TITLE

An Ostomy Appliance

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to an ostomy appliance and to a method of applying an ostomy appliance body side member around a stoma.

In connection with surgery for a number of diseases in the gastro-intestinal or uri- nary tract a consequence is, in many cases, that the colon, the ileum or the ureter has been exposed surgically and the patient is left with an abdominal stoma, or, in nephrostomy or ureterostomy, the ureter or a catheter is exposed in the back or the chest region or abdominal region, 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 accommodating the stoma/ureter/catheter. Also in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.

Ostomy appliances are well known. Such appliances may be two-piece or one- piece appliances. In both types of appliances, an adhesive barrier member (or base plate) is attached to the wearer's abdomen/back/chest. In case of a one- piece appliance, a receiving member or bag is attached to the base plate. In case of a two-piece appliance, the adhesive barrier member forms part of a body side member and a receiving member or bag is attached releasably to the body side ostomy member for receiving exudates from the stoma.

When using one-piece appliances, the whole appliance, including the adhesive skin barrier securing the appliance to the skin is normally removed and replaced by a fresh appliance. When using two-piece appliances, the body side ostomy member is left in place up to several days, and only the receiving member or bag attached to the body side member is replaced. The attachment means for attaching an ostomy receiving bag may e.g. be a system se comprising matching coupling rings or matching flanges and adhesive surfaces engaging with and sealing against a flange area of the body side member.

It is necessary to change the body side member of a two-piece appliance when the centre part of the adhesive wafer has been sufficiently deteriorated to allow access of the aggressive exudates to the skin surrounding the stoma, irrespective of the fact that the wafer as such has a much longer wearing time. The access of aggressive exudates to the skin is causing skin problems.

Frequent changing of the body side member of a two-piece appliance is undesirable due to the irritation of the skin and the quality of life of the user may be improved and the nuisance of the wearing of an ostomy appliance reduced if the intervals between exchanging of body side member can be increased.

The service time of the body side ostomy member depends inter alia of the amount and the aggressiveness of the exudates and of the sealing between the stoma and the body side ostomy member.

The sealing depends on the fit to the stoma. Conventionally, only a limited number of standard appliances having holes of different size are available and the user or an assistant must customise the body side member by cutting the edge of the hole to adapt the body side member to the stoma. However, the resulting hole may show an exposed edge which may injure the surface of the stoma e.g. when the user bends or turns due to the exposed edge of the carrier sheet which after cutting even may show a serrated edge.

2. Description of the Related Art When cutting the edge of the hole of an adhesive wafer of a conventional one- piece ostomy appliance for adapting the same to the size and shape of a stoma the cutting is complicated by the fact that in order to secure discretion, for decora- tive purposes and for providing softness, low noise generation and comfort the bag is often made from an opaque material or covered and/or provided with a cover or front layer rendering it very difficult, if not impossible for the user or the nurse to observe the stoma area during determination of a cutting line for adapta- lion of the hole or when applying the appliance.

Published International Patent Applications Nos. WO 98/17212 and WO 98/53771 disclose ostomy appliances comprising a body side member comprising an adhesive wafer for securing the appliance to the user's skin, said wafer having a hole for receiving a stoma, and an optionally separately exchangeable receiving member or bag secured to the body side ostomy member for receiving secretions from the ostomy said ostomy appliance further comprising a sealing member disposed in the hole of the wafer surrounding the stoma and having a hole for accommodating the stoma.

The ostomy appliance disclosed in Published International Patent Application No. WO 98/53771 has a sealing member having balanced plastic and elastic properties allowing a better adaptation of the hole of the ostomy appliance to a stoma by a temporary enlarging of the hole by everting or rolling up the inner rim of the hole for accommodating the stoma.

WO 98/17212 and WO 98/53771 only teach the use of such a sealing member together with two-piece ostomy appliances and do neither disclose nor indicate how to use a sealing member together with one-piece ostomy devices.

It has been found desirable in practice to make use of separate sealing members for facilitating the adaptation of ostomy appliances and the sealing between the ostomy appliance and the stoma.

If used with a one-piece ostomy appliance, such a sealing member would be difficult to manipulate for several reasons. Firstly, it is very difficult to adapt the sealing member to the stoma after applying the ostomy appliance if the sealing member has a tacky surface on the side facing the bag as it will then adhere to the bag during attempts to adapt the sealing member to the stoma which must be performed by pressing the wall of the bag against the sealing member. Then, also a risk exists that the wall of the bag is torn when trying to disengage the contact.

Secondly, due to the measures to secure discretion, for decorative purposes and for providing softness, low noise generation and comfort stated above it also in this case very difficult, if not impossible for the user or the nurse to observe the stoma area during adaptation of such a sealing member when applying one- piece appliances.

SUMMARY OF THE INVENTION The invention relates to an ostomy appliance comprising a front wall and a rear wall of flexible material forming a bag, said rear wall having an opening for receiving a stoma, and said rear wall also being provided with an adhesive wafer for securing the appliance to a user's skin, said wafer having a first hole being aligned with the opening for receiving the stoma, wherein the opening has an edge being secured to the surface of the adhesive wafer facing away from the user in an attachment zone surrounding the hole of the wafer, said ostomy appliance further comprising a sealing member having a second hole for receiving the stoma and a flange projecting from an outer rim thereof.

Furthermore, the invention relates to am ostomy sealing member comprising a mouldable adhesive material which member shows adhesiveness to adhere to the skin of an ostomate and to seal around a stoma and between the stoma and an ostomy appliance adapted to receive secretions from the stoma and a sufficient cohesion to be removed in one piece without leaving remaining adhesive material on the skin, said sealing member having a hole for receiving the stoma and a flange projecting from an outer rim thereof. Still further, the invention relates to methods of applying to an ostomate an ostomy appliance comprising a front wall and a rear wall of flexible material forming a bag, said rear wall having an opening for receiving a stoma, and said rear wall also being provided with an adhesive wafer for securing the appliance to a user's skin, said wafer having a hole being aligned with the opening for receiving the stoma, said opening comprising a sealing member having a second hole for receiving the stoma and a flange projecting form an outer rim thereof, wherein the opening of the bag has an edge being secured to the surface of the adhesive wafer facing away from the user in an attachment zone surrounding the hole of the wafer.

Brief Description of the Drawings

The invention is disclosed more in detail with reference to the drawings in which Fig. 1 shows a sectional view of an embodiment of an ostomy appliance of the invention after application to the skin of an ostomate,

Fig. 2 shows a sectional view of another embodiment of an ostomy appliance of the invention after application to the skin of an ostomate, Fig. 3 shows collection bag for use as a part of an ostomy appliance of the invention in its open state, Fig. 4 shows a further embodiment of an ostomy appliance of the invention in its open state applied to a users abdomen,

Fig. 5 shows further embodiment of an ostomy appliance of the invention in its closed state, and Fig. 6 shows a stiffening element for use in an ostomy appliance of the invention.

Detailed Description of the Present Invention

In its broadest aspect the present invention relates to an ostomy appliance in the form of a set comprising a one-piece appliance and a sealing member. The invention relates to an ostomy appliance comprising a front wall and a rear wall of flexible material forming a bag, said rear wall having an opening for receiving a stoma, and said rear wall also being provided with an adhesive wafer for securing the appliance to a user's skin, said wafer having a first hole being aligned with the opening for receiving the stoma, wherein the opening has an edge being secured to the surface of the adhesive wafer facing away from the user in an attachment zone surrounding the hole of the wafer, said ostomy appliance further comprising a sealing member having a second hole for receiving the stoma, wherein the sealing member has a flange projecting from an outer rim thereof, said flange having an outer diameter greater than the diameter of the first hole, and said flange comprising a skin-friendly adhesive at a first surface to be placed on the abdomen of an ostomate, and said flange comprising a second surface being capable of adhering to the adhesive at the surface of the wafer to be secured to the user's skin.

Thus in connection with one-piece appliances it is possible to work with a sealing member which is cut or rolled and shaped and positioned around the stoma and brought into sealing contact with the stoma whereafter a one-piece appliance having a hole having a diameter usable with all stoma sizes but still having a sealing overlap with the sealing member is applied.

In a second aspect the invention relates to an ostomy appliance comprising a front wall and a rear wall of flexible material forming a bag, said rear wall having an opening for receiving a stoma, and said rear wall also being provided with an adhesive wafer for securing the appliance to a user's skin, said wafer having a first hole being aligned with the opening for receiving the stoma, wherein the opening has an edge being secured to the surface of the adhesive wafer facing away from the user in an attachment zone surrounding the hole of the wafer, said ostomy appliance further comprising a sealing member having a second hole for receiving the stoma, wherein a first part of the edge of the opening of the bag is secured to the surface of the wafer in a corresponding first part of the attachment zone, wherein a second, remaining part of the edge of the opening of the bag is prepared for adhesive sealing of the same to the remaining second part of the attachment zone, and wherein the sealing member has a flange projecting from an outer rim thereof, said flange having an outer diameter greater than the diameter of the first hole, and said flange comprising a skin-friendly adhesive at a first surface to be placed on the abdomen of an ostomate, and said flange comprising a second surface being capable of adhering to the adhesive at the surface of the wafer to be secured to the user's skin.

As a part of the edge of the bag of a one-piece appliance is not secured to the adhesive wafer, that part of the edge may be folded back giving access to the stoma area from the distal side of the appliance facing away from the user during the application of the appliance. Thus, a simple evaluation of the stoma area for cutting the wafer for adapting the same to the specific stoma and manipulation and location of an adhesive wafer in relation to the stoma is enabled. All such adaptation and application may be carried out having full view over the stoma area from the distal side. Then, edge of the bag is easily sealed to the wafer along the remaining part of the attachment zone, and thus along the full periphery of the bag, using an adhesive. The adhesive is preferably protected by a release liner until the final sealing of the bag. The bag is preferably sealed permanently to the wafer. Thus, in use, after application the product works like a conventional one-piece appliance, and advantages of access to the stoma area when working with two-piece appliances are transferred to the one-piece technology.

The resulting hole may however show an exposed edge which does not provide a sufficient sealing against a stoma ensuring that no leak occurs and may injure the surface of the stoma e.g. when the user bends or turns due to the exposed edge of the carrier sheet which after cutting even may show a serrated edge.

The use according to the invention of a sealing member enables the use of such a sealing member with conventional one-piece ostomy appliances and enables an easy manipulation and shaping of such sealing member before application and to seal against the stoma avoiding direct contact between the stoma and the edge of the hole.

The use of such a separate sealing member also enables a reduction in the number of available sizes of holes as one or a few large sizes of holes may be tailored to most stomas using the separate sealing member, which has not been possible for one-piece ostomy appliances until now. Furthermore, the cutting for enlarging the hole of an ostomy appliance for accommodating a stoma is rendered easier as the fit is not critical.

In accordance with a suitable embodiment of the invention, the second part of the edge of the bag is secured to one surface of a stiffening element reducing the risk of wrinkling of the edge of the bag.

When the first and the second part of the edge of the bag are secured to a first and a second part, respectively, of one surface of the stiffening element, the handling of the bag and the securing of the first part of the edge of the bag to the first part of the attachment zone are facilitated and the process is readily adapted for automatic production.

A stiffening element is preferably in the form of a ring being secured to the circumference of the opening of the bag. Such stiffening element may suitably be made from a plastics material, which is flexible and relatively rigid so that it is substantially dimensionally stable under normally occurring loads. Polyolefins, particularly polyethylene, e.g. in the form of a blend of high and low density poly- ethylenes, have been found suitable, but other materials having similar properties may be used. The stiffening element may alternatively be in the form of a flange of a foam material such as a cellular plastic material conventionally used for production of flanges for ostomy appliances. A polyurethane foam is suitably used.

The adhesive for adhesive sealing of the second part of the edge of the bag or the stiffening element to the second part of the attachment zone is suitably an "aggressive" adhesive material providing an immediate grip when contacted with the other surface after removing a release liner. It is preferred that the adhesive material has a sufficient thickness and is sufficiently mouldable to provide a reliable sealing of the edge of the bag. A suitable adhesive material is a pressure sensitive adhesive suitable for use with the parts to be united such as acrylic ad- hesives, elastomeric adhesives, polyurethane adhesives, or polyester adhesives. The choice of adhesive may be made in accordance with the above requirements, as it is not critical for the invention in the respect that the adhesive is not in contact with the skin. It is also contemplated that the adhesive properties of the adhesive and the second part of the edge of the bag or the stiffening element and the second part of the attachment zone are balanced enabling an opening and reseating of the bag, if desired.

It is suitable when the stiffening element is a flat ring provided with two notches dividing the flat ring into two parts. The shape of such ring should correspond to the shape of the attachment zone and may e.g. be circular or elliptical. Such notches provide predetermined zones in which the stiffening element is readily folded back giving access to the distal side of the adhesive wafer. The notches may be present on the proximal surface of the stiffening element of on the distal surface of the stiffening element whichever deemed most appropriate. When placed on the distal surface of the stiffening element, care must be taken when securing the edge of the bag to the stiffening element that the edge of the bag is reliably sealed to the surface without canals in the notch-area. The securing may e.g. be effected by welding or suitably applying an adhesive, preferably in an amount ensuring a reliable sealing in the notch-area. A combination of a welding seam and adhesive sealing may be used if deemed appropriate.

It is especially suitable to locate the notches stretch essentially along a chord of the circular ring facilitating the bending of the stiffening element. The notches stretch essentially along a diameter of the circular ring giving a large opening to the stoma site in the ostomy appliance.

In one embodiment of the invention the part of the stiffening element secured the second part of the bag is provided with an adhesive layer being covered by a pro- tecling layer. In case that the notches are located on the proximal surface of the stiffening element, care must be taken to ensure that the notch is sealed reliably when adhering the second of the edge of the bag to the second part of the at- tachment zone, e.g. by applying a sufficient amount of adhesive material to fill the notch.

A stiffening element to be used in accordance with the present invention may be made by a method known per se for manufacturing products from the selected materials such as injection moulding, die casting, pressing, or foaming using corresponding moulds. Alternatively, a stiffening element may be cut from a work- piece of the desired material such as a foam block. A notch may be prepared when forming the stiffening element or later using methods known per se such as cutting or milling.

In another embodiment of the invention the second part of the attachment zone of the wafer is provided with an adhesive layer being covered by a protecting layer. In case that the notches are located on the proximal surface of the stiffen- ing element, care must also be taken in this case to ensure that the notch is sealed reliably when adhering the second of the edge of the bag to the second part of the attachment zone, e.g. by applying a sufficient amount of adhesive material at the site of the attachment zone near the notch to fill the notch.

In a further embodiment of the invention, the front wall is provided with an opening provided with cover, which may be released and resealed and thus giving temporary access to the internal space of the bag for inspection of the stoma area during the service time of the ostomy appliance. Such opening is especially of interest in the first period after a stoma having been made in order to allow an inspection of the newly formed stoma without having to remove the appliance and also for establishing a suitable regime for exchange of appliances for the ostomate in question. The opening may be provided with a closure corresponding to an adhesive coupling normally used for coupling of collection bags to ostomy body side members of two-piece appliances or a conventional coupling ring for coupling of collection bags to ostomy body side members of two-piece appliances and a matching closure such as the closure disclosed in WO 98/38952. In a third aspect the invention relates to an ostomy sealing member comprising a mouldable adhesive material which member shows adhesiveness to adhere to the skin of an ostomate and to seal around a stoma and between the stoma and an ostomy appliance adapted to receive secretions from the stoma and a suffi- cient cohesion to be removed in one piece without leaving remaining adhesive material on the skin, said sealing member having a hole for receiving the stoma and a flange projecting from an outer rim thereof, said flange having an outer diameter greater than the diameter of a hole of the ostomy appliance for receiving the stoma, and said flange comprising a skin-friendly adhesive at a first surface to be placed on the abdomen of an ostomate, and said flange comprising a second surface being capable of adhering to the adhesive at the surface of the wafer to be secured to the user's skin.

A sealing member may suitably be made of a material of the kind disclosed in US Patent No. 6,509,391 , or 6,332,879. Thus, the elastic and plastic properties may be selected by the skilled in the art in accordance with the desired properties for the actual purpose, including a self-sealing effect obtainable using a sealing member made from an adhesive material showing absorbing and swelling properties when contacted by aqueous material.

The sealing member may be made in different materials for e.g. colostomy, ileo- stomy, or ureterostmy purposes for fulfilling special requirements with respect to e.g. adhesiveness and water absorption. The choice for a specific use is readily made by the skilled in the art, optionally after few routine experiments. Collection bags with an adhesive wafer only need to be available in a few sizes as the demands on the bag only differ very little for the different types of stomas.

In one embodiment, the sealing member is in the form of a laminate having a hy- drophobic surface facing away from the skin and a water-absorbing surface fac- ing the skin enabling the sealing element and the bag to adhere safe to the skin even under extreme humid conditions. It is preferred that the sealing member has a surface facing away from the user providing a safe adhesion to the adhesive wafer of the bag. It may be suitable to taper the edge of the adhesive wafer and of the sealing member to provide a smooth transition with minimum difference in thickness.

In case the sealing member is relatively thin, it may be suitable to provide the edge of the hole of the adhesive wafer with a bevelling, e.g. of the kind disclosed in US Patent No. 4,867,748 in order to reduce the area of adhesive at the edge of the hole which is exposed to the material discharged through the stoma in order to prolong the service time of the ostomy appliance.

Suitable skin friendly adhesive materials for use for a sealing member of the invention are e.g. the types disclosed in those disclosed in US patent Nos. 4,367,732, 5,051.259, 5,714,225, 6,171,594, 6.303,700, 6,451 ,883, or 6,437,038, or in WO Publication Nos. 00/54820, or 01/05340.

In a fourth aspect the invention relates to a method of applying to an ostomate an ostomy appliance comprising a front wall and a rear wall of flexible material forming a bag, said rear wall having an opening for receiving a stoma, and said rear wall also being provided with an adhesive wafer for securing the appliance to a user's skin, said wafer having a hole being aligned with the opening for receiving the stoma, said opening comprising a sealing member having a second hole for receiving the stoma and a flange projecting form an outer rim thereof, wherein the opening of the bag has an edge being secured to the surface of the adhesive wafer facing away from the user in an attachment zone surrounding the hole of the wafer, wherein the flange has an outer diameter greater than the diameter of the first hole, said method comprising locating the sealing member, locating the stoma, enlarging the second hole of the sealing member by everting or rolling an inner rim of the second hole adapting the size and shape of the hole to the stoma, aligning the stoma and the second hole and placing the sealing member on the abdomen of the ostomate with the stoma projecting into said second hole and bringing the sealing member to seal against the stoma, locating the ostomy appliance, aligning the stoma and the hole of the adhesive wafer, placing the ad- hesive wafer on the flange and the abdomen of the ostomate with the stoma projecting into the hole of the wafer.

The handling of a one-piece ostomy appliance of the invention differs from the handling of two-piece ostomy appliances or one-piece appliances of the state of the art comprising a sealing material for sealing against a stoma as the sealing member is applied first whereafter the one-piece appliance which may be a one- piece appliance known per se is applied on the sealing member.

In a fifth aspect the invention relates to method of applying to an ostomate an ostomy appliance comprising a front wall and a rear wall of flexible material forming a bag, said rear wall having an opening for receiving a stoma, and said rear wall also being provided with an adhesive wafer for securing the appliance to a user's skin, said wafer having a hole being aligned with the opening for receiving the stoma, said opening comprising a sealing member having a second hole for receiving the stoma and a flange projecting form an outer rim thereof, wherein the opening of the bag has an edge being secured to the surface of the adhesive wafer facing away from the user in an attachment zone surrounding the hole of the wafer, wherein a first part of the edge of the opening of the bag is secured to the surface of the wafer in a corresponding first part of the attachment zone, wherein a second, remaining part of the edge of the opening of the bag is prepared for adhesive sealing of the same to the remaining second part of the attachment zone, and wherein the flange has an outer diameter greater than the diameter of the first hole, said method comprising locating the sealing member, locating the stoma, enlarging the second hole of the sealing member by everting or rolling an inner rim of the second hole adapting the size and shape of the hole to the stoma, aligning the stoma and the second hole and placing the sealing member on the abdomen of the ostomate with the stoma projecting into said second hole, locating the ostomy appliance, aligning the stoma and the hole of the adhesive wafer, placing the adhesive wafer on the flange and the abdomen of the ostomate with the stoma projecting into the hole of the wafer, and bringing the sealing member to seal between the adhesive wafer and the stoma. The adhesive wafer may comprise any skin-friendly adhesive known per se, e.g. an adhesive comprising hydrocolloids or other moisture absorbing constituents for prolonging the time of use forming the surface to be secured to the user's skin. The adhesive may e.g. be of the type disclosed in those disclosed in US patent Nos. 4,367,732, 5,051.259, 5,714,225, 6,171 ,594, 6.303,700, 6,451 ,883, or 6,437,038, or in WO Application Nos. 00/54820, or 01/05340.

A carrier sheet may be present on the surface of the adhesive wafer facing the bag and may any suitable thermoplastic material known per se for use in the preparation of ostomy appliances e.g. a foam, a non-woven layer or a polyure- thane, polyethylene, polyester or polyamide suitable for attachment of a collecting bag using an adhesive or by welding.

The collection bag may be made in analogy with and from materials convention- ally used for the preparation of ostomy appliances. Such materials are suitably films composed of any suitable material, which is heat sealable and sufficiently impervious for unpleasant odours such as polyolefin films or combinations of such films, e.g. polyethylene or a coextrudate of polyethylene and polyvinylidene chloride. Suitably the bag is made from front and rear walls welded in a manner known per se along the rim forming a bag. When cutting or punching the walls, an opening for receiving a stoma is suitably also punched in the wall to form the rear wall.

A protective cover or release liner may for instance be siliconized paper. It does not need to have the same contour as the dressing, e.g. a number of dressings may be attached to a larger sheet of protective cover. The protective cover is not present during the use of the dressing of the invention and is therefore not an essential part of the invention.

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 Figs. 1 and 2 showing a sectional view of embodiments of an ostomy appliance of the invention in its closed state after application to the skin of an ostomate. The ostomy appliance comprises a front wall 2 and a rear wall 3 of flexible material forming a bag, said rear wall having an opening 4 for receiving a stoma 12, and said rear wall also being provided with an adhesive wafer 5 for securing the appliance to a user's skin S, said wafer having a hole 6 being aligned with the opening for receiving the stoma. A sealing member 13 of the invention having a hole 14 for receiving the stoma and a flange 15 projecting from an outer rim thereof, said flange having an outer diameter greater than the diameter of a hole of the ostomy appliance for receiving the stoma is placed on the user's skin under a part of the adhesive wafer. In Fig. 2 is shown an embodiment of a sealing member in, which the edge of the hole for receiving the stoma has been rolled forming a torus 16 of adhesive material. The edges of the hole of the adhesive wafer and the outer part of the flange of the sealing member have been tapered for providing a smooth transition with minimum difference in thickness.

Reference is made to figure 3, which shows an ostomy appliance in the form of a collection bag 1 for use as a part of an ostomy appliance of the invention in its open state. The ostomy appliance comprises a front wall 2 and a rear wall 3 of flexible material forming a bag, said rear wall having an opening 4 for receiving a stoma, and said rear wall also being provided with an adhesive wafer 5 for securing the appliance to a user's skin, said wafer having a hole 6 being aligned with the opening for receiving the stoma, wherein the opening has an edge 7,7' being secured to the surface of the adhesive wafer facing away from the user in an attachment zone 8 surrounding the hole of the wafer, wherein a first part of the edge 7 of the bag is secured to the surface of the wafer in a corresponding first part of the attachment zone, and wherein a second, remaining part T of the edge of the bag is prepared for adhesive sealing of the same to the remaining second part 8 of the attachment zone. The edge of the opening of the bag is provided with a stiffening element 9. Fig. 4 shows another embodiment of an ostomy appliance 11 of the invention in its open state applied to a users abdomen. The ostomy appliance comprises a front wall 2 and a rear wall 3 of flexible material forming a bag, said rear wall having an opening 4 for receiving a stoma 12, and said rear wall also being provided with an adhesive wafer 5 for securing the appliance to a user's skin, said wafer having a hole 6 being aligned with the opening for receiving the stoma, wherein the opening has an edge 7,7' being secured to the surface of the adhesive wafer facing away from the user in an attachment zone 8 surrounding the hole of the wafer, wherein a first part of the edge 7 of the bag is secured to the surface of the wafer in a corresponding first part of the attachment zone, and wherein a second, remaining part 7' of the edge of the bag is prepared for adhesive sealing of the same to the remaining second part 8 of the attachment zone. The edge of the opening of the bag is provided with a stiffening element 9. In the hole 6 of the wafer is seen a part of a separate sealing member 13 sealing against the stoma 12.

Fig. 5 shows further embodiment of an ostomy appliance 21 of the invention in its closed state seen from the surface facing away from the user. The ostomy appliance corresponds to the embodiment shown in Fig.1 except that in front wall 2 is provided with an opening provided with cover 14, which may be released and re- sealed and thus giving temporary access to the internal space of the bag for inspection of the stoma area during the service time of the ostomy appliance.

Fig. 6 shows a stiffening element 31 for use in an ostomy appliance of the invention. The stiffening element is in the form of a circular ring 32 provided with two notches 33 dividing the circular ring into two parts. The notches provide predetermined zones in which the stiffening element is readily folded. The notches are in this embodiment placed on the surface to be attached to an adhesive wafer of an ostomy appliance of the invention.

Claims

1. An ostomy appliance comprising a front wall and a rear wall of flexible material forming a bag, said rear wall having an opening for receiving a stoma, and said rear wall also being provided with an adhesive wafer for securing the appliance to a user's skin, said wafer having a first hole being aligned with the opening for receiving the stoma, wherein the opening has an edge being secured to the surface of the adhesive wafer facing away from the user in an attachment zone surrounding the hole of the wafer, said ostomy appliance further comprising a sealing member having a second hole for receiving the stoma, wherein the sealing member has a flange projecting from an outer rim thereof, said flange having an outer diameter greater than the diameter of the first hole, and said flange comprising a skin-friendly adhesive at a first surface to be placed on an ostomate's skin, and said flange comprising a second surface being capable of adhering to the adhe- sive at the surface of the wafer to be secured to the user's skin.

2. An ostomy appliance comprising a front wall and a rear wall of flexible material forming a bag, said rear wall having an opening for receiving a stoma, and said rear wall also being provided with an adhesive wafer for securing the appliance to a user's skin, said wafer having a first hole being aligned with the opening for receiving the stoma, wherein the opening has an edge being secured to the surface of the adhesive wafer facing away from the user in an attachment zone surrounding the hole of the wafer, said ostomy appliance further comprising a sealing member having a second hole for receiving the stoma, wherein a first part of the edge of the opening of the bag is secured to the surface of the wafer in a corresponding first part of the attachment zone, wherein a second, remaining part of the edge of the opening of the bag is prepared for adhesive sealing of the same to the remaining second part of the attachment zone, and wherein the sealing member has a flange projecting from an outer rim thereof, said flange having an outer diameter greater than the diameter of the first hole, and said flange comprising a skin-friendly adhesive at a first surface to be placed on the abdomen of an ostomate, and said flange comprising a second surface being capable of adhering to the adhesive at the surface of the wafer to be secured to the user's skin.

3. An ostomy appliance as claimed in claim 1 or 2 wherein the second part of the edge of the bag is secured to one surface of a stiffening element.

4. An ostomy appliance as claimed in claim 3 wherein the first and the second part of the edge of the bag are secured to a first and a second part, respectively, of one surface of the stiffening element.

5. An ostomy appliance as claimed in claim 3 or 4 wherein the stiffening element is a flat ring provided with two notches dividing the flat ring into two parts.

6. An ostomy appliance as claimed in claim 5, wherein the notches stretch es- sentially along a chord of the flat ring.

7. An ostomy appliance as claimed in claim 6, wherein the notches stretch essentially along a diameter of the flat ring.

8. An ostomy appliance as claimed in any of claims 3-7 wherein the part of the stiffening element secured the second part of the bag is provided with an adhesive layer being covered by a protecting layer.

9. An ostomy appliance as claimed in any of claims 3-7 wherein the second part of the attachment zone of the wafer is provided with an adhesive layer being covered by a protecting layer.

10. An ostomy sealing member comprising a mouldable adhesive material which member shows adhesiveness to adhere to the skin of an ostomate and to seal around a stoma and between the stoma and an ostomy appliance adapted to receive secretions from the stoma and a sufficient cohesion to be removed in one piece without leaving remaining adhesive material on the skin, said sealing mem- ber having a hole for receiving the stoma and a flange projecting from an outer rim thereof, said flange having an outer diameter greater than the diameter of a hole of the ostomy appliance for receiving the stoma, and said flange comprising a skin-friendly adhesive at a first surface to be placed on the abdomen of an ostomate, and said flange comprising a second surface being capable of adhering to the adhesive at the surface of the wafer to be secured to the user's skin.

11. A method of applying to an ostomate an ostomy appliance comprising a front wall and a rear wall of flexible material forming a bag, said rear wall having an opening for receiving a stoma, and said rear wall also being provided with an adhesive wafer for securing the appliance to a user's skin, said wafer having a hole being aligned with the opening for receiving the stoma, said opening comprising a sealing member having a second hole for receiving the stoma and a flange projecting form an outer rim thereof, wherein the opening of the bag has an edge being secured to the surface of the adhesive wafer facing away from the user in an attachment zone surrounding the hole of the wafer, wherein the flange has an outer diameter greater than the diameter of the first hole, said method comprising locating the sealing member, locating the stoma, enlarging the second hole of the sealing member by everting or rolling an inner rim of the second hole adapting the size and shape of the hole to the stoma, aligning the stoma and the second hole and placing the sealing member on the abdomen of the ostomate with the stoma projecting into said second hole and bringing the sealing member to seal against the stoma, locating the ostomy appliance, aligning the stoma and the hole of the adhesive wafer, placing the adhesive wafer on the flange and the ab- domen of the ostomate with the stoma projecting into the hole of the wafer.

12. A method of applying an ostomate an ostomy appliance comprising a front wall and a rear wall of flexible material forming a bag, said rear wall having an opening for receiving a stoma, and said rear wall also being provided with an ad- hesive wafer for securing the appliance to a user's skin, said wafer having a hole being aligned with the opening for receiving the stoma, said opening comprising a sealing member having a second hole for receiving the stoma and a flange pro- jecting form an outer rim thereof, wherein the opening of the bag has an edge being secured to the surface of the adhesive wafer facing away from the user in an attachment zone surrounding the hole of the wafer, wherein a first part of the edge of the opening of the bag is secured to the surface of the wafer in a corre- spending first part of the attachment zone, wherein a second, remaining part of the edge of the opening of the bag is prepared for adhesive sealing of the same to the remaining second part of the attachment zone, and wherein the flange has an outer diameter greater than the diameter of the first hole, said method comprising locating the sealing member, locating the stoma, enlarging the second hole of the sealing member by everting or rolling an inner rim of the second hole adapting the size and shape of the hole to the stoma, aligning the stoma and the second hole and placing the sealing member on the abdomen of the ostomate with the stoma projecting into said second hole, locating the ostomy appliance, aligning the stoma and the hole of the adhesive wafer, placing the adhesive wa- fer on the flange and the abdomen of the ostomate with the stoma projecting into the hole of the wafer, and bringing the sealing member to seal between the adhesive wafer and the stoma renders it possible for a nurse use sealing members together with one-piece appliances and enables a nurse to observe the stoma area during adaptation of such a sealing member when applying one-piece appli- ances.