Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Patent
1996-09-24
1998-02-17
Clarke, Robert A.
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
604332, 604338, 604344, A61F 544
Patent
active
057186960
DESCRIPTION:
BRIEF SUMMARY
This is a 371 of PCT/DK/00114 filed Mar. 10, 1995.
BACKGROUND OF THE INVENTION
The invention concerns an ostomy appliance whose proximal side has a convex face which is provided with adhesive by means of which the ostomy appliance can be adhered to the skin of a user, and whose distal side carries a collection bag or a coupling part therefor.
Below an ostomy patient or an ostomist denotes a person having a colostomy, an ileostomy or a urostomy. In such persons the colon, the ileum or the ureter has been exposed surgically such that the waste products of the body, which are conveyed through these organs, are discharged through an artificial opening and are collected in a collection bag, which is ordinarily adhered to the skin by means of an adhesive plate with an opening surrounding the stoma.
It is frequently seen in ostomy patients that the closest surroundings of the stoma, at a distance of 1-2 cm, are recessed or are positioned in a crater or a cavity with respect to the rest of the skin surface that surrounds the stoma. For such patients it is expedient to use an ostomy product where the adhesive surface around its opening for receiving the stoma has a part which is convex and protrudes toward the user with a view to enabling the adhesive face of the ostomy appliance to engage and adhere to the skin everywhere in the crater or the cavity. In particular, it is important that the ostomy appliance adheres well to the skin as closely to the stoma as possible, and this location is most frequently the one lying deepest. The shape of the forwardly protruding part of the adhesive face may e.g. be domed or conical, and such products are known under the designation convex products. Throughout the specification the term convex has this broad meaning irrespective of the actual embodiment. EP 317 326 describes a convex product where a rigid ring, on its entire convex side, carries an intermediate ring of a soft thermoplastic foam adhered to the rigid ring. The intermediate ring carries a layer of adhesive to position the product on the skin of a user. The foam ring is a cost-adding component, and the attachment by gluing to the rigid ring adds to the cost of the manufacturing process.
WO 93/04646 and EP 416 397 describe convex products where a layer of adhesive suitable for use on the human skin is arranged directly on the convex face of a ring-shaped body. In these convex products the convex shape of the adhesive is given by the convex shape of the ring-shaped body, and the adhesive has no possibility of adapting its shape to the user's shape around the stoma. Accordingly, air pockets may occur, which causes deficient adhesion to the user's skin.
DESCRIPTION OF THE INVENTION
With an ostomy appliance comprising a ring shaped body having a convex proximal side and a distal side and as well as an inner periphery and an outer periphery, and a layer of adhesive to attach the ring-shaped body to a user's skin with the proximal side facing the user's skin, which is characterized in that the adhesive is present on a thermoplastic carrier sheet having at least the same extent as the adhesive, and that the carrier sheet is disposed between the adhesive and the ring-shaped body and is attached to the proximal side of the ring-shaped body along the inner periphery and the outer periphery thereof with mutual spaces. The layer of adhesive is not firmly connected to the ring-shaped body over the entire convex face of the body, but can move with respect to the body. The layer of adhesive is hereby able to follow irregularities in the skin around the user's stoma and to adhere completely to the skin without air pockets. This ensures a more stable adhesion of the ostomy appliance to the user's skin.
The production of ostomy products with a flat proximal adhesive side includes producing a plane disc of adhesive suitable for use on the human skin which is provided with a plastics sheet on both sides. The plastics sheet on the distal side of the adhesive is attached, e.g. by gluing or welding, to a collection bag or to a couplin
REFERENCES:
patent: 4834731 (1989-05-01), Nowak et al.
patent: 4973323 (1990-11-01), Kaczmarek et al.
patent: 5185008 (1993-02-01), Lavender
patent: 5330454 (1994-07-01), Klingler et al.
Clarke Robert A.
Coloplast A/S
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