Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1999-08-09
2004-03-23
Lo, Weilun (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
Reexamination Certificate
active
06709421
ABSTRACT:
The present invention relates to ostomy pouches for the collection of waste, or discharge, from a temporary or permanent ostomy opening. The invention is applicable equally to so-called one piece designs in which the pouch is integral with an attachment pad or wafer for attaching the pouch to the body of the ostomate, and with so-called two-piece designs in which the pad or wafer for securing the pouch to the ostomate is separate from, and is releasably attachable to, the pouch.
One aspect of the invention relates to a filtered flatus vent which is commonly provided in certain ostomy pouches. The vent allows flatus gas within the pouch to escape, in order to avoid ballooning of the pouch. A sticker is sometimes provided which is initially adhered over the exit from the vent in order to prevent, initially, any gas from flowing through the vent. The purpose of this is, when the pouch is first worn, to allow some gas to build up within the pouch and thereby prevent the sides of the pouch from sticking to each other, which could cause undesirable pancaking. Once the pouch has begun to inflate (and the sides separated from each other), the sticker can be removed in order to allow flatus to vent in the normal way.
In one broad aspect, the invention provides a filtered vent for an ostomy pouch having a plurality of outlets, and adhesive sticker means which can be positioned to selectively expose or cover one or more of the plurality of outlets.
This aspect can provide a very simple, yet, convenient way of allowing the user to control the flow rate of flatus passing through the vent. This is in contrast to the prior art in which the sticker and the single exit can provide only on/off control. When the sticker is removed, if the flow rate of gas through the filter is too high (depending on a particular person's metabolism and on the food consumed), the sides of the pouch may tend to stick to each other again, and cause pancaking. However, with this aspect of the present invention, the ostomate can selectively cover, or uncover, a desired number of the outlets to control the rate at which flatus vents, and thereby control the degree of pouch inflation to prevent pancaking.
In one embodiment, the sticker means might be dimensioned so that it is of sufficient size to be able to cover all the outlets (when positioned appropriately) and can expose one or more of the exits by being moved to an offset position.
In an alternative embodiment, the patch means may consist of a number of separable sticker segments which can be peeled away to selectively expose one or more exits under each segment.
In a yet further form, the sticker means may comprise a plurality of individual stickers each of which can be attached, or removed, from a respective exit.
The exits may be in the form of slits, or other apertures, formed in a plastics film covering, for example, the filter. Alternatively, the exits may be in the form of clearances between one or more welds, or weld segments.
If desired, a flow constricting layer may be provided upstream of the outlets (for example, under a plastics layer having outlet apertures). This can allow the apertures to be made larger, and more easily identifiable, without such critical dependency on aperture size.
In a further aspect, the invention provides a vent for an ostomy pouch, the vent comprising aperture means, a flow constricting layer upstream of the aperture means, and adhesive sticker means which can be positioned to selectively block one or more areas of the aperture means.
The presence of the flow constricting layer can enable larger aperture(s) to be used because the flow is constricted by the layer. The aperture may either be a single aperture (for example, a relatively large aperture), or a plurality of individual apertures.
The flow constricting layer may, for example, consist of micro-porous material. The layer might, in some embodiments, by formed by a filter element.
In a further aspect, the invention relates to an ostomy pouch having a so-called comfort layer. Such a comfort layer is generally soft and permeable, and is provided outside the non-permeable plastics wall of the pouch to provide more comfortable wearing characteristics. Customers generally prefer a comfort layer to be provided on both the rear face (i.e. adjacent to the skin) and on the front face (i.e. facing the wearer's clothing).
In this aspect, the invention provides an ostomy pouch in which a first wall of the pouch is provided with a comfort layer and with a flatus vent, the pouch further comprising adhesive sticker means attached, or attachable to the vent to control the flow of flatus through the vent.
Preferably, the outlet of the vent is defined by at least one segment of smooth, substantially impermeable, plastics material positioned outside the comfort layer. This can provide surface with excellent characteristics to allow the adhesive sticker means to adhere to provide a gas-tight (or at least substantially gas-tight) seal, and thereby enable the sticker to control the flow of gas through the vent. To the best of the inventor's knowledge, it is unknown hitherto to employ a sticker for a vent through a wall carrying a comfort layer. In particular, it might difficult to achieve a gas-type seal if the sticker is applied directly to the comfort layer. In the preferred embodiment, the provision of the smooth plastics material outside the comfort layer can overcome this problem.
As explained previously, there is a need for some form of device, at least initially, to block or constrict the flow of flatus through the vent, in order to prevent pancaking. The ability to provide a simple adhesive sticker means with a comfort-layer adorned pouch is an extremely significant advantage.
Preferably, the comfort layer is provided outside the majority of at least the upper portion of the pouch. Preferably, the smooth material described above overlies a portion of the comfort layer, and is secured to the underlying wall of the pouch through the comfort layer (for example, by welding, or by adhesive).
Preferably, the smooth material outside the comfort layer forms an outer cover for the filter, and is secured to the underlying pouch wall around the filter. The line of attachment (e.g. welding) may be continuous, or it may be discontinuous to provide one or more vent exits.
In another aspect, the invention relates to the construction of a filtered vent for an ostomy pouch which has a comfort layer.
In this third aspect, the invention broadly provides an ostomy pouch comprising a first wall of substantially liquid and gas impermeable plastics material, an aperture being provided in the first wall to allow the venting of flatus, a comfort layer provided outside the first wall, and a filter cover layer outside the comfort layer and secured to the first wall through the comfort layer, the cover layer and the portion of the first wall underlying the cover layer defining a housing in which is received a filter for processing the flatus vented through the aperture.
The filter may, for example, include material for deodorising the flatus, and/or material for absorbing any liquid which accidentally escapes through the aperture in the first wall.
The filter may be positioned between the first wall and the comfort layer. In that case, the filter is preferably attached to the first wall, to provide a seal around the aperture in the first wall. Alternatively, the filter may be provided between the comfort layer and the cover layer. In that case, the filter may either be attached to the cover layer, or it may be attached to the first wall.
A yet further aspect of the invention relates to the adhesive wafer which is provided conventionally for securing the pouch to the wearer's skin.
In accordance with this broad aspect, the wafer (or a cover layer provided on the wafer) is provided with guidelines for enabling a person to cut the wafer to a desired aperture size, the guidelines including at least one generally circular guideline, and at least one generally non-circular guideline.
Preferably,
Bogart Michael
Bristol--Myers Squibb Company
Krieger Stuart E.
Lo Weilun
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