Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1999-12-20
2002-06-04
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, C604S338000, C604S339000, C604S341000, C604S342000, C604S385190
Reexamination Certificate
active
06398768
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a faecal management device for babies, children or adults to be attached to the perianal area of the wearer, said device having optimum containment properties, i.e., being so configured as to avoid detachment of the bag when the bag contains faecal material, in a wide range of wearing conditions, including situations in which the wearer is not bedridden, but active.
BACKGROUND OF THE INVENTION
Faecal management devices are known articles of manufacture that are designed to be worn principally by incontinence sufferers and in particular by bedridden patients. Such faecal management devices are attached to the perianal region of the wearer and are intended to entrap and immediately contain faecal material and other bodily discharges. Such devices as they are mostly known today are constituted of a relatively long and narrow tube at one extremity of which is positioned the aperture and the attachment device, which can be adhesive.
Because of their shape and dimensions, such devices can twist around the thighs of the wearers and lead to folds and kinks in the devices themselves. Such features naturally affect the storage capacity of the device and may result in unintentional detachment of the device from the wearer leading to undesirable and distressing consequences both for the wearer and carer. Moreover such devices hinder the free movement of the wearer.
Such bags are disclosed in e. g. the following documents:
U.S. Pat. No. 3,577,989, which details a disposable elimination-trapping bag for incontinence sufferers including a container member having an open-top portion, and a flange secured to the container member around the open-top portion. The container member includes two opposed side members, preferably substantially identical, and of a generally rectangular configuration, joined together along common edges. U.S. Pat. No. 4,784,656, which describes a receptacle for collecting faecal matter from incontinence sufferers. The faecal collector comprises a gasket, conduit means or a cylinder and a receptacle; the receptacle and conduit means are each formed from two sheets of thermoplastic film that are heat sealed along their side edges, respectively. GB 2 152 387, which teaches a faecal collector for incontinence sufferers comprising a collection bag and a ring. The faecal collector comprises a pair of panels of thermoplastic sheet material joined at their margins to define an elongate bag having an opening at one end. In a preferred embodiment, the collection bag is formed from a single sheet of odour-barrier thermoplastic film folded along a vertical midline to provide a pair of continuous panels. SE 8 104 934, which discloses an oblong bag made from a thin, flexible and fluid tight material. The collecting bag comprises an inlet portion and a bottom portion at an angle of 120 degrees to the longitudinal direction of the inlet portion. The bag is so designed as to enable it to assume an advantageous position along the thigh of the person when in use.
Other types of faecal management bags of a flatter shape are known from EP 245 064. Such types of flatter bags are also disclosed in U.S. Pat. No. 4,946,720, particularly suited however for collecting faecal matters discharged through the artificial anus. EP 245 064 discloses bags having a front and a rear wall, the front wall containing the aperture and attachment means to the body. The general shape of said front and rear wall is rectangular, i.e., the bag has two opposed long sides and two opposed short sides, the width of the bags being relatively short compared to the length of the bag. Furthermore, the aperture in the front wall is positioned close to one of said short sides of said front wall. Such bags, while improved over the tube-type bags described hereinabove, are still not exhibiting optimum containment properties, especially not in a wide range of wearing conditions.
Hence, a real consumer need can be identified for a faecal management device, which is correctly shaped and dimensioned so as to guarantee the wearer maximum functionality, excellent coverage of the buttocks, and superior comfort.
A problem naturally associated with these devices is their secure attachment to the human body whilst allowing for the faecal matter to be safely contained within the bag. The approach which is mostly used in the field is to provide the device with a flange which surrounds an aperture and provide adhesive on the flange, which will provide sufficient adhesion to the perianal area.
As it is known in the art, the secure adhesive attachment of the faecal management device to allow for a variety of wearing conditions is not easily achieved: The area of the flange is limited, since on the one hand the aperture needs to be of a sufficient size and on the other hand the flange should not be too large for good anatomical fit. Furthermore the adhesive should not be too aggressive in order to avoid pain during the removal of the device.
The wearing conditions will depend on the nature of the wearer; when the wearer is active, such as a baby or a child, or an incontinent adult not being bedridden, the wearing conditions for the bag will become much more stressed and the risk of detachment of the bag will increase substantially, due to the movement of the wearer and pressure from the wearer's body, if the containment properties are not optimum, i.e., there is a likelihood that the faecal material, once excreted and contained in the bag, will exert pressure, in particular onto the inner periphery of the flange, which may result in the unintentional detachment of the bag. Sitting on the bag, for example, will result in a largely reduced volume in some areas of the bag.
Furthermore such pressure exerted by the entrapped faecal material occurring in various wearing conditions may lead to the rupture of the bag, which is an undesirable and distressing consequence, even if only minor leakage of the bag is induced by a rupture. The seals, where different pieces of material used for the bag are joined, e.g. by heat sealing, are typically less resistant to rupture under pressure than other areas of the bag. The weakest areas along such seals are typically bends occurring at the corners of a bag, e.g. when made of essentially rectangular pieces of material as described in the prior art. Bags for faecal management devices are typically made in mass production under economic constraints. Thus a bag having a shape which avoids the need for particularly high quality seals of high economic benefit for the producer and also provides an at least psychological assurance for the user.
It has now been found that the above drawbacks will be substantially alleviated if the bags are configured in a specific manner, thus allowing utilization of the bags for babies, children and active adult incontinents in addition to bedridden adult management device with a specific shape and dimension. It has been found that the resultant faecal management device is uniquely advantageous and exhibits an enhanced level of efficiency and comfort.
It has also been found that the position of the aperture in said specifically configured bags should preferably be selected as well.
In another aspect of the present invention, the faecal management device with its specifically configured shape and dimensions can be advantageously used in combination with a reusable underwear garment or preferably with a disposable diaper.
SUMMARY OF THE INVENTION
The present invention relates to a faecal management device (
10
) comprising a bag (
11
), said bag (
11
) having an aperture (
21
) and a flange (
12
) surrounding said aperture for adhesive attachment to perianal of a wearer. The invention resides principally in providing said bag (
11
) in an optimal shape and with optimal containment properties, so that detachment of the bag is avoided, when the bag contains faecal material, in a wide range of wearing conditions, including situations in which the wearer not bedridden, but active. The present invention relates to a faecal managem
D'Acchioli Vincenzo
Palumbo Gianfranco
Bogart Michael
Huston Larry L.
Kolodesh Michael S.
Patel Ken K.
Weiss John G.
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