Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1995-02-17
2003-08-05
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...
C604S338000
Reexamination Certificate
active
06602232
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention is directed to ostomy systems, and more particularly to a novel ostomy system that permits repeated removal of an adhesively installed ostomy pouch to permit repositioning of the pouch around the stoma.
Ostomy systems with adhesive coupling devices for securing an ostomy pouch around a stoma are shown in European Patent Application Publication 0 611 122 A1. After an ostomy pouch has been adhesively secured around a stoma, it is often desirable to make a further readjustment of the pouch position. However, it is well known that removal of an adhesively secured pouch from its position around a stoma can cause wrinkling or kinks in the faceplate of the pouch that includes the adhesive coupling member. Pouch removal can also cause wrinkling and kinks in a body-side mounting wafer that surrounds the stoma and forms a landing surface for the pouch faceplate when the pouch is adhesively secured to the abdominal area.
Removal and resecurement of an adhesively mounted closed-end pouch after the pouch has been worn for at least a day is especially troublesome since the mounting wafer landing surface for the pouch does not usually remain flat and smooth after a full day's wear. Readherence of the pouch to a non-smooth landing surface is likely to produce gaps or channels at the adhesive interface between the pouch faceplate and the body-side mounting wafer. Such gaps are detrimental to the integrity of the seal between the pouch and wafer, and can provide a path for undesirable leakage of vapor and material from the pouch.
Thus, an ostomy system which has leaks at the interface between the pouch and the body-side wafer due to repositioning of the pouch may require complete replacement of the entire system before it has been used for the normal time duration.
It is also common practice for a user to have assistance in placing or positioning a pouch on the abdomen in order to ensure that the pouch is satisfactorily positioned around the stoma. However, if assistance is not available when needed, the user may proceed to install the ostomy pouch without assistance, thereby risking unsatisfactory positioning and a need for readjustment of the pouch position.
The risk of wrinkle formation at the interface between an adhesively secured pouch and a body-side wafer because of a prospective need for repositioning of the pouch can discourage use of adhesively secured pouches, even though adhesive coupling is generally less bulky than mechanical coupling devices.
It is thus desirable to provide an ostomy system that permits easy removal and repositioning of an adhesively secured pouch without damaging the pouch faceplate or the mounting wafer and without compromising the leak-tight securement of the pouch during such repositioning.
OBJECTS AND SUMMARY OF THE INVENTION
Among the several objects of the invention may be noted the provision of a novel ostomy system, a novel ostomy system with a repositionable ostomy pouch, a novel ostomy system wherein the pouch is adhesively secured and repositionable without compromising a leak-tight seal between the pouch and a body-side wafer, a novel ostomy system wherein an installed body-side wafer remains substantially flat and smooth to provide a flat landing zone around the stoma, even after the pouch is removed from the installed wafer, a novel ostomy system wherein a stiffening member is provided on a body-side wafer to minimize the formation of wrinkles or folds on an installed wafer during repositioning of a previously installed ostomy pouch, a novel ostomy system wherein an ostomy pouch includes a refastenable adhesive member, and a novel method of repositioning an ostomy pouch around a stomal opening.
Other objects and features of the invention will be in part apparent and in part pointed out hereinafter.
In accordance with the invention, the ostomy system includes a repositionable pouch, which can be closed-end or drainable, and a body-side mounting wafer. The pouch comprises an envelope formed of flexible plastic sheet material that defines a chamber for collection of body waste from the stoma. A waste inlet opening is formed in the pouch to receive waste material that passes from the stoma into the collection chamber. Coupling means for securing the pouch to the body-side mounting wafer are provided on the pouch envelope at the waste inlet opening. The body-side mounting wafer has a stomal opening and an adhesive layer on one side for securement of the wafer to the body surface around the stoma. An opposite side of the wafer is engageable with the pouch coupling means.
The ostomy system coupling means include a resealable tape and a releasable film, one of which is provided on the pouch and the other of which is provided on the body-side mounting wafer.
In a preferred embodiment of the invention, the resealable tape is provided on the pouch and the releasable film is provided on the body-side mounting wafer. Thus the pouch can be secured to the wafer when the resealable tape engages the releasable film. The releasable film and the resealable tape permit repeated removal of the pouch from the wafer and repeated resecurement and/or replacement of a closed-end pouch to the wafer.
Under this arrangement the pouch can be easily repositioned on the body-side wafer, even after the pouch has been worn for a day.
The ostomy system also includes a support means disposed behind the releasable film to inhibit the formation of wrinkles on the releasable film and help keep the film flat and smooth. By maintaining the releasable film flat and smooth, leak-tight seals are obtainable between the pouch and the wafer, even when the pouch is repositioned several times on the body-side wafer.
A stiffening member can also be provided behind the resealable tape of the pouch coupling member to facilitate application of the pouch to the body-side wafer.
In several embodiments of the invention the resealable tape of the pouch is mounted on an outside surface of the pouch envelope. In other embodiments of the invention the resealable tape is mounted on an inside surface of the pouch envelope, such that exposed portions of the resealable tape are bordered by the pouch side-wall.
In some embodiments of the invention the support means of the body-side wafer are coextensive with the releasable film and a body-side adhesive. In other embodiments of the invention the support means include two support members, one of which is of smaller extent than the releasable film.
The faceplate of the pouch, which includes the pouch coupling member, can be heat-welded or adhesively bonded to a wall of the pouch.
The invention also includes a method of repositioning an ostomy pouch around a stomal opening, including the securing of a body-side wafer around the stomal opening, providing the mounting wafer with a landing surface formed of releasable film and providing the ostomy pouch with an adhesive coupling having an exposed resealable tape for engagement with the releasable film of the body-side mounting wafer to permit repeated removal, replacement and resecurement of the pouch to the mounting wafer.
The invention accordingly comprises the constructions and method hereinafter described, the scope of the invention being indicated in the claims.
REFERENCES:
patent: 4701169 (1987-10-01), Steer
patent: 4890608 (1990-01-01), Steer
patent: 4894058 (1990-01-01), Jensen
patent: 5496296 (1996-03-01), Holmberg
E.R. Squibb & Sons, Inc.
Krieger Stuart E.
Ruhl Dennis
Weiss John G.
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