Ostomy appliance with perforated flange

Details Ostomy appliance with perforated flange Ostomy appliance with perforated flange

2001-05-21

2003-09-30

Mar, Michael (Department: 3751)

Surgery

Means and methods for collecting body fluids or waste material

Receptacle attached to or inserted within body to receive...

C604S332000, C604S342000, C604S344000

Reexamination Certificate

active

06626878

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to an ostomy appliance comprising a body side member comprising an adhesive wafer or pad for securing the appliance to the user's skin, said wafer or pad having a hole for receiving a stoma, and a separately exchangeable receiving bag secured to the body side ostomy member for receiving secretions from the ostomy, wherein the body side member comprises a first substantially annular first flange which is fixedly connected to the base plate and the receiving bag comprises a substantially annular second flange adapted for removable and adhesive coupling and sealing to said fist flange.
DESCRIPTION OF THE RELATED ART
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 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. 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, 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.
When using one-piece appliances, the whole appliance, including the adhesive wafer or pad securing the appliance to the skin is removed and replaced by a fresh appliance. When using two-piece appliances, a body side ostomy member or carrier device is left in place for several days, and only the receiving member or bag is replaced.
The service time of the body side ostomy member depends on the amount and aggressiveness of the exudates and of the tightness between the ostomy and the body side ostomy member.
In a collecting system of this type known from EP patent application No. 0 276 043, a flange for adhesive connection with the flange of the collecting bag or with the bag itself being fastened on a base plate in the form of an adhesive pad.
In such a collecting system, the base plate of the carrier device must be able to remain on the user over a long period of time, for example up to 8-10 days. During this whole period of time, the carrier device must be capable of undergoing deformation owing to the user's movements, washing, exposure to bag replacements, etc. Conventionally, the base plate of such a carrier device is designed as a thin adhesive foil, optionally with some sort of stiffening reinforcement disc for maintaining a plane adhesive surface for the bag. However, such a reinforcement disc prevents the base plate from following the contours of the body when the user moves, and it does not provide the desired shock absorbing effect between the collecting bag and the user, which, of course, reduces comfort. A less rigid disc would be able to follow the base plate during such movements, to be sure, but would thus exert a pull in it, which, in addition to transmitting an unpleasant pulling effect to the user's skin, also weakens the adhesive effect between base plate and skin. Furthermore, the adhesive surface facing the bag will not in that case remain plane owing to the inevitable deformations, which results in problems of rearranging the bag on the user.
In the above EP patent application, an attempt has been made to eliminate these problems by connecting a rigid flange with the base plate via a flexible sheet, which, however, provides an unstable and insecure connection. Furthermore, the adhesive connection taught between bag and carrier device is provided either by a number of layers of adhesive applied to the flange of the base plate and activated one after the other, which reduces the number of times to which the base plate may be exposed to a change of bag to the number of layers of adhesive, or by using a new bag with a fresh layer of adhesive, which renders the system more expensive in use.
One solution to this problem is disclosed in the applicants own WO 96/38106 in which is disclosed an ostomy collecting system which comprises a collecting bag having an inlet opening formed in a bag wall and with surrounding connecting elements for connection with a stoma in a user, and a carrier device for the collecting bag. The carrier device comprises a base plate for fastening on the user and a substantially annular first flange connected to the base plate via a first connecting section. The connecting elements comprise a substantially annular second flange, which is fixedly connected to the collecting bag via a substantially annular second connecting section and is designed for removable and adhesive connection with said first flange. The first and the second flanges are connected with the base plate and the collecting bag, respectively, in such a manner that the outer radius of said second connecting section exceeds the outer radius of said first connecting section by a value which at least equals the total thickness of the first and the second flanges. The adhesive connection between the collecting bag and the carrier device is provided by a layer of adhesive applied on said second flange and capable of repeated adhesion with the first flange, and the first and the second flanges are made from a flexible and resilient material.
Although this design provides a connection between carrier device and collecting bag, which is stable against displacement forces, and which acts as a shock absorbing element there is still a need for a even more safe solution in which the connecting surface between the collecting bag and the body side member is maintained largely independently of the deformation of the body side member caused by, for example, the user's movements, but which is nevertheless stable and continues to exhibit an even and flexible adhesive surface without wrinkles or gaps opening for passage of liquid between the flanges of the bag and the body side member. It is a further object that it should be possible to remove and reapply one or more bags repeatedly without any reduction in the life of the base plate and to reduce the necessary cleaning of the body side member when substituting the collecting bag.
SUMMARY OF THE INVENTION
The invention relates to a substantially annular flange for an ostomy collecting bag. The flange is divided in a radial direction into an inner portion and an outer portion by at least one opening therethrough in a substantially circular zone.
Furthermore, the invention relates to an ostomy collecting bag having a substantially annular flange connected thereto by a substantially annular connecting section. The annular flange is designed for removable and adhesive connection with a second flange connected with a body side member of an ostomy appliance by a second connecting section. The annular flange has at least one opening therethrough so as to divide the annular flange into an inner portion and an outer portion in a radial direction.
Still further, the invention relates to an ostomy appliance having a body side member with an adhesive wafer for securing the appliance to a user's skin, the wafer having a hole for receiving a stoma, and a separately exchangeable collecting bag. A substantially annular first flange is connected to the body side member via a first connecting section, and a substantially annular second flange is connected to the collecting bag via a second connecting section for adhesive connection with the first flange. The second flange has at least one opening therethrough that divides the second flange into an inner portion and an outer portion in a radial direction.


REFERENCES:
patent: 3667469 (1972-06-01), Marsan
patent: 47239

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