Ostomy appliance

Details Ostomy appliance Ostomy appliance

2000-02-29

2001-11-06

Weiss, John G. (Department: 3761)

Surgery

Means and methods for collecting body fluids or waste material

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

C604S327000, C604S332000, C604S336000, C604S337000, C604S338000, C604S339000, C604S341000, C604S343000, C604S344000

Reexamination Certificate

active

06312415

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to an ostomy appliance, and the use of a mechanical fastening means for securing a separately exchangeable receiving member or bag for receiving secretions from an ostomy to a body side ostomy member.
BACKGROUND OF THE INVENTION
In connection with surgery for a number of diseases in the gastro-intestinal tract a consequence is, in many cases, that the patient is left with an abdominal stoma such as a colostomy, an ileostomy or an urostomy. In such cases or 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 secretions 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, the body side ostomy member is let 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 secretions and of the tightness between the ostomy and the body side ostomy member.
In the known appliances it is necessary to change the body side member of two-piece appliance when the centre part of the adhesive wafer or pad has been sufficiently deteriorated to allow access of the aggressive secretions 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 secretions to the skin is causing skin problems.
Skin problems are common for persons having a stoma. Generally, about 40% have skin problems (Pearl et. al. 1985 “Early local complications from intestinal stomas”, Arch. Surg. 120; 1145-1147.) and the frequency is especially high for persons having an urostomy or ileostomy. About 80% of the persons having an ileostomy have skin problems (Hellman, J. D., Lago, C. P. 1990 “Dermatologic complications in colostomy and ileostomy patients”, International Journal of Dermatology, 29 (2); 129-133.). The skin problems are mostly pronounced in a circular area about the stoma ½ inch from the stoma) (Hellman and Lago 1990).
Frequent changing of the body side member of a two-piece appliance or the frequent exchange of a one-piece appliance is undesirable due to the irritation of the skin and the quality of life 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.
It is known to place a ring on the skin before applying the body side member or to make a filling between the edge of the stoma and the shaped whole of the ostomy appliance in order to form a seal between the stoma and the ostomy appliance in order to alleviate the problems using a commercially available medical grade adhesive paste. Such pastes are e.g. sold by Bristol-Myers Squibb under the trademark Stomahesive® or by Coloplast under the trade mark Coloplast® Paste.
These pastas, however, do not have a composition which has a sufficiently cohesion ensuring safe removal thereof without leaving residues on the skin and, on the other hand, the pastes often are so sticky that they cannot easily be shaped using the finger without sticking to the finger.
A paste should have a composition which is sufficiently tacky to secure the appliance or skin barrier to the abdomen, and cohesion ensuring safe removal thereof without leaving residues on the skin. On the other hand, the paste must not be so sticky that it cannot easily be shaped by a finger or hand without sticking to the hand. Furthermore, the paste must show a sufficient elasticity in order to be able to follow the movements of the patient without slipping the skin and should also show a great resistance to erosion caused by aggressive secretions from an ostomy.
In GB Patent Application No. GB 2 290 974 is disclosed an ostomy appliance wherein a body-side is combined with a mouldable mass of non-hypoallergenic, non-memory putty-like adhesive, particularly based on hydrocolloid or hydrogel.
GB Patent Application No. GB 2 290 974 discloses a body-side ostomy member comprising a ring to which a bag-side coupling ring or a bag can be attached, said ring comprising a rib and a flange, said flange being mounted on a wafer of medical grade adhesive having a central whole of diameter at least 65% of the internal diameter of the ring. A mouldable mass of non-hypoallergenic, non-memory putty-like adhesive, particularly based on hydrocolloid or hydrogel, is disposed radially inward of the wafer so that it forms a protective mass surrounding the stoma. The mouldable mass has a thickness of 1.25-3 times that of the wafer and a central hole therein of a diameter no more than {fraction (1/10)} th of the internal diameter of the ring. Both the medical grade adhesive and the mouldable adhesive are adhered to the skin.
European Patent application No. EP 0 686 281 discloses an ostomy appliance comprising a collection pouch and faceplate assembly including a flexible patch having a stoma-receiving opening, a first layer of skinfriendly hydrocolloid-containing adhesive material along one side of said patch about said opening for securing said faceplate assembly to peristomal skin surfaces, and a second layer of relatively soft, easy-deformable and extrudable, adhesive sealant material of a composition that is resistant to being dissolved or disintegrated by stomal fluids and that immediately surrounds said opening; said second layer being displaceable inwardly and axially into said opening for forming a stoma-engaging annular gasket to prevent stomal fluids from contacting the peristomal skin and said first adhesive layer.
The mouldable mass of non-hypoallergenic, non-memory putty-like adhesive or flexible patch disclosed in GB Patent Application No. GB 2 290 974 and European Patent application No. EP 0 686 28 both are secured to the rim of the hole for receiving the stoma.
Published GB patent application No. 2 041 753 discloses an ostomy appliance 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, a stoma sealing duct and a separately exchangeable receiving member or bag secured to the body side ostomy member for receiving secretions from the ostomy, wherein the separately exchangeable receiving member is secured releasably to the body side member by a mechanical fastening means.
The ostomy appliances disclosed in GB Patent Application No. GB 2 290 974 and European Patent application No. EP 0 686 281 as well as GB patent application No. 2 041 753 suffer from the drawback that the mouldable sealing material is only foreseen to be changed together with the body side member of the appliance. There is no teaching nor indication that the mouldable sealing material might be exchanged separately without removing the body-side member from the skin. Such separate exchange is not possible either for the embodiments shown in the drawings of these applications.
It has suprisingly been found that it is possible to provide an ostomy appliance having a separate sealing member disposed in the hole of the wafer or pad surrounding the stoma offering a convenient and comfortable solution to the above problems and at the same time separating the two functions of the sealing around an ostomy and the securing of a separately exchangeable receiving member or bag for receiving secretions from an ostomy to a body side ostomy member.
None of the above mentioned patents describes the use of a separate sealing member which may be exchanged or substituted separately.
This idea according to the invention differs from the above mentioned patents since the c

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