Convex insert system for an ostomy appliance

Details Convex insert system for an ostomy appliance Convex insert system for an ostomy appliance

1998-12-15

2001-04-03

Yasko, John B. (Department: 3763)

Surgery

Means and methods for collecting body fluids or waste material

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

C604S342000

Reexamination Certificate

active

06210384

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to ostomy appliances and more particularly to an insert attachable to an ostomy coupling so as to provide it with a convex curvature.
Various kinds of ostomy devices are known in the art. A two piece ostomy device typically includes a faceplate having two sides with an adhesive dressing on one side that adheres to the peristomal area of the patient's skin and a pouch which is removably affixed to the opposite side of the faceplate. When a coupling system is employed with a two piece ostomy device, a first coupling member in the form of a plastic ring surrounds an opening in the faceplate which receives the stoma. A second coupling member, also in the form of a plastic ring, is bonded to the ostomy bag around the inlet opening. The first coupling is secured to the second coupling. This can be accomplished by providing the first coupling ring with a rib and the second coupling ring with a channel as described in U.S. Pat. No. 4,460,366 issued Jul. 17, 1984 to Steer, et al. The rib of the first coupling is dimensioned so as to lodge within the channel of the second coupling ring.
A convex insert is particularly helpful in situations where the stoma does not sufficiently protrude beyond the abdominal skin surface or where the muscle surrounding the stoma lack rigidity. In these situations the flat surface of the faceplate does not provide a fluid tight and weight supporting seal. Also, it is considered desirable to cause a stoma that does not normally protrude to protrude into the ostomy appliance. In order to address these situations a faceplate with a convex curvature which is created by a convex insert is considered desirable. The convex insert is secured around the stoma so as to apply pressure against the patient's abdomen thereby causing the stoma to protrude.
U.S. Pat. No. 5,163,930 to ConvaTec discloses a convex insert that is designed for use with a coupling ring having an axially extending rib. The insert is securely lodged under the radially extending surface which partially defines the rigid sealing flange. The insert includes a convex annular body with an arcuate relatively non-deformable portion and a deformable circumferential portion. The deformable portion has an outer edge with a circumference normally slightly larger than the inner circumference of the sealing flange. The circumference of the deformable portion is temporarily reduced as the convex insert is inserted into the coupling ring. Once the insert is positioned under the flange surface, the circumference of the insert returns to its normal surface and the insert is securely seated. The convex insert disclosed in this patent cooperates with and is in contact with the axially extending rib of the coupling ring.
It is an objective of the present invention to provide a convex insert system separate from the portions of the body side and pouch side couplings that join the couplings together.
It is a further objective of the present invention for the convex insert to form a circumferential seal with the coupling on which it is mounted.
SUMMARY OF THE INVENTION
The convex insert of the present invention is entirely resiliently deformable. The resiliently deformable body of the insert includes a circumferential edge and at least one projection or tab, but preferably a plurality of projections or tabs, on its outer surface. The projections are is positioned proximate to the circumferential edge. The convex insert is mounted on an ostomy coupling. The coupling is preferably a circular body-side coupling have a central opening. The coupling includes an annular surface around the opening. The opening fits around the patient's stoma. The inner surface of the coupling includes a radially projecting rib extending at least partly circumferentially around the inner surface. The rib preferably extends around the entire circumference. When deformed the convex insert is capable of insertion into the annular inner surface so that the projection is lodged against the radially extending rib so that the convex insert is captured within the opening upon its resilient return into a substantially undeformed condition.
The convex insert system works well with a modified version of the three piece locking system disclosed in U.S. Pat. Nos. 5,662,628 and 5,662,629, commonly assigned herewith. The three piece system includes a body side coupling, pouch side coupling and a locking ring. Pursuant to the present invention a coupling is modified so as to include a radially projecting rib on its inner annular surface.
It is possible to mount the convex insert on a bag-side coupling that is properly modified to include an inwardly projecting rib.


REFERENCES:
patent: 5163930 (1992-11-01), Blum
patent: 5693036 (1997-12-01), Kilgour
patent: 5730735 (1998-03-01), Holmberg et al.
patent: 5947941 (1999-09-01), Leise, Jr. et al.
patent: WO93/18725 (1993-09-01), None

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