Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
2002-07-03
2004-11-09
Calvert, John J. (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C337S344000
Reexamination Certificate
active
06814720
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a medical appliance comprising a body side member comprising an adhesive wafer for securing the appliance to the patient's skin, said wafer or pad having an aperture allowing bodily fluids or exudates to enter the appliance, and an optionally separately exchangeable collecting bag secured to the body side ostomy member for collecting fluids or excretions.
BACKGROUND OF THE INVENTION
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 is 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 which has developed between an internal organ and the abdominal surface, the patient will have to rely on an appliance to collect the bodily material emerging from such opening. Collecting bags may also be used for collecting exudates from a wound or collection of bodily material in connection with post operation or drainage purposes.
Such appliances are well known and 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 collecting member or bag is attached to the body side member for collecting exudates from the stoma or wound 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, the body side member is left in place for several days, and only the collecting 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.
DESCRIPTION OF THE RELATED ART
The service time of ostomy appliances may be reduced for several reasons. Due to the aggressiveness of the exudates, the adhesive material of the adhesive wafer may deterioriate and give access to the skin for the exudates. This may call for a change of appliance in order to protect the skin. Furthermore, a leakage around the stoma may give rise to appearance of unpleasant materials or odours at the abdomen of the patient which may give rise to skin problems as well as embarrassing situations. In order to increase the service time of especially ostomy appliances it has been proposed to adapt the size of the aperture of the adhesive wafer to the size of the actual stoma. One-piece ostomy appliances and body side members of two-piece ostomy appliances are normally offered having adhesive wafers having a range of sizes of apertures for better adaptation to the size of the actual stoma and the adhesive wafer is often provided with a cutting guide typically having series of concentric printed lines having an indication of the diameter thereof for facilitating a more accurate customisation using e.g. scissors.
GB Patent Application No. 2 017 501 discloses a device for sealing an ostomy bag to the skin of a patient which device comprises a sheet of material capable of adhering to the skin of a patient and having a slit or cut extending as a spiral or the like. An aperture may then be produced in the sheet by unwinding the coil defined by the slit. The sheet may be of a gelatinous material having a basis of Karaya gum and/or another hydrophilic material.
The appliances disclosed in GB Patent Application No. 2 017 501 are one-piece appliances.
U.S. Pat. No. 3,604,421 discloses a one piece disposable bag having a variable size opening surrounded by separately removable concentric annular strips for forming an opening of variable diameter. However U.S. Pat. No. 3,604,421 is silent with respect to the problems associated with removal of all of the bag when substituting the bag.
These two references are silent with respect to problems concerning a complete removal of the bag flange of the appliances when substituting the bag and both teach the presence of a central disc to be removed before using the appliance.
In connection with two-piece appliances, the size of the aperture of the collecting bag for receiving a stoma is often greater than the size of the apertures of the commonly used body side members, and there is a considerable risk of access of exudates to the distal surface of the adhesive wafer of the body side member. This opens the door for chemical attack on the adhesive from the “back” and may furthermore give rise to soiling or contamination of the distal surface of the body side member, especially in connection with ileostomies and colostomies. This may reduce the wearing time of the body side member and furthermore give rise to problems when substituting the collecting bag with a fresh bag as the coupling area may have to be cleaned in order to ensure a proper coupling and sealing of the fresh bag and also to ensure that residues giving rise to unpleasant odours are not left on the body side member. Altogether there is a considerable risk of having to exchange the body side member before its technical service time has been exhausted.
It has been found that these drawbacks may be alleviated by the present invention.
SUMMARY OF THE INVENTION
The invention relates in its broadest aspect to a medical appliance comprising a body side member comprising a flange in the form of an adhesive wafer for securing the appliance to a patient's skin, said wafer having an aperture allowing bodily fluids or exudates to enter the appliance, and an optionally separately exchangeable collecting bag secured to the body side member for collecting fluids or excretions, wherein the flange has an inner rim defining the aperture therein and a central area encircling the aperture which area has a predetermined weakening pattern.
The invention further relates to a medical appliance comprising a body side member comprising an adhesive wafer for securing the appliance to a patient's skin, said wafer having an aperture allowing bodily fluids or exudates to enter the appliance, and a separately exchangeable collecting bag having a bag flange having an aperture allowing bodily fluids or exudates to enter the appliance, wherein the body side member comprises first coupling means being fixedly connected to the body side member and the collecting bag comprises corresponding second coupling means adapted for releasable coupling and sealing to the body side member, wherein the bag flange has an inner rim defining the aperture therein and a central area encircling the aperture which area has a predetermined weakening pattern.
Furthermore, the invention relates to an ostomy collecting bag having a bag flange having an aperture allowing bodily fluids or exudates to enter the appliance, the bag comprising coupling means for releasable coupling and sealing to corresponding coupling means fixedly connected to a body side member comprising an adhesive wafer for securing the body side member to a patient's skin, said wafer having an aperture allowing bodily fluids or exudates to enter the appliance, wherein the bag flange has an inner rim defining the aperture therein and a central area encircling the aperture which area has a predetermined weakening pattern.
Still further, the invention relates to a flange for a medical collecting bag in the form of a substantially annular flange having an inner rim defining an aperture therein and a central area encircling the aperture which area has a predetermined weakening pattern
REFERENCES:
patent: 3604421 (1971-09-01), Pizzella
patent: 4095599 (1978-06-01), Simonet-Haibe
patent: 4367732 (1983-01-01), Poulsen et al.
patent: 0 276 042 (1988-07-01), None
patent: 2 017 501 (1979-10-01), None
patent: WO
Leisner Henrik
Olsen Eskil Hoelland
Calvert John J.
Coloplast A/S
Jacobson & Holman PLLC
Truong Linh
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