Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1998-03-05
2001-04-17
Lewis, Kim M. (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C604S317000
Reexamination Certificate
active
06217562
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of water-dispersible disposable health care goods and particularly but not exclusively to ostomy and faecal and urinary incontinence pouches.
BACKGROUND OF THE INVENTION
There are a surprisingly large number of patients, most notably in the UK and USA, who have undergone major surgery of the digestive track and are reliant upon a colostomy or ileostomy pouch to collect unabsorbed or excreted waste material from the digestive tract. For such patients use of these pouches represents a very considerable hardship and invariably involves wearing the pouch for many hours on end and awkward fitment and removal at frequent intervals with the further problem that upon removal of the pouch it must then be disposed of.
Fitment and removal of an ostomy pouch is generally carried out within the confines of a water closet and the pouch then is either emptied of its contents into the water closet bowl with the pouch then being binned or sealed away for carriage to a remote waste disposal unit or the pouch is adapted to be flushed away, following emptying or complete with its contents.
A variety of different designs of ostomy bag exist that are adapted for flushing and which are, for example, either adapted to be softened in the cold water of the toilet bowl or dispersed in hot water such as arises in the sludge digester of a sewage treatment plant and as disclosed in, for example, GB 2 290 968.
For those designs that are adapted to disperse or biodegrade in the environment of a sludge digester this does not, of course, facilitate the flushing of the product or its transit through the soil pipe and sewage drains. Other product designs are adapted to disperse upon contact with cold water when the pH of that water is adjusted to a level at which the material of the pouch is cold water soluble. Examples of the latter include U.S. Pat. No. 5,417,677 and GB 2 195 919. Such prior art systems of flushing disposal of ostomy and incontinence pouches are, however, not necessarily swift methods of disposal or do not allow for complete dispersal prior to flushing or, furthermore, require the carrying of potentially dangerous acid or alkali by the patient/wearer.
It is a general objective of the present invention to provide an ostomy/incontinence pouch or bag that is rapidly dispersible for flushing down a water closet without necessitating carrying of acidic or alkaline substances to facilitate the dispersion.
SUMMARY OF THE INVENTION
According to a first aspect of the present invention there is provided a water-dispersible disposable enclosure such as an ostomy pouch or urinary incontinence pouch which is adapted for flushing down the bowl of a water closet and is formed of a material that at the time of disposal into a water closet bowl is combined with a water-activated exothermic reagent that raises the temperature of the enclosure or the water that comes into contact with the enclosure, prior to or upon placement in the water closet bowl, to a level at which the material melts, dissolves or otherwise disperses for ease of flushing.
The preferred material of the enclosure is a hot water soluble material such as hot water soluble polyvinyl alcohol and the preferred water-activated exothermic reagent is silica gel, aluminium chloride or calcium chloride. Each of these water-activated exothermic reagents is capable of raising the localised temperature of the aqueous media within the enclosure or the immediately surrounding water to a level of 60° C. or 80° C. necessary to dissolve or disperse the hot water soluble polyvinyl alcohol from which the enclosure is formed or to heat and melt an enclosure formed of low melting point material such as 60° C. MP polycaprolactone film.
It will be appreciated that the material forming the enclosure is not soluble, dispersible or meltable at body temperature and is, therefore, not vulnerable to degradation by the warm bodily liquids that it is adapted to store. Therefore, by provision of the water-activated exothermic reagent only upon the external surface of the enclosure the enclosure is vulnerable only to externally applied water/aqueous media. Alternatively, by introducing the exothermic reagent into the enclosure only at time of disposal it retains its integrity until disposal.
The water-activated exothermic reagent may be coated upon the external surface of the enclosure at the time cf manufacture and may be applied continuously or discontinuously as necessary to achieve adequate disintegration of the product upon disposal. For the greater comfort of the user, depending upon the nature of reagent used, the reagent may be best applied substantially solely to the face of the pouch/enclosure that is remote from the wearer, rather than adjacent the skin of the wearer.
The water-activated exothermic reagent may be applied at the time of disposal by means of a spray, wipe or applicator pen or may be incorporated in or on the enclosure, for example inside a sachet which is punctured or ruptured by the action of a tool or force after the useful life of the enclosure or within a pocket: on the enclosure that is cold water soluble to release the reagent upon placements in the bowl of the water closet, or may be introduced into the enclosure through a valve.
According to a second aspect of the present invention there is provided a water-dispersible disposable enclosure such as an ostomy pouch or urinary incontinence pouch, which enclosure is formed from a material that is rapidly soluble in an organic solvent and which solvent is introduced into. released onto or coated onto the external surface of the enclosure at the time of disposal into a water closet bowl.
The present invention also provides a method of disposal of a water disposable enclosure of the second aspect of the invention which includes the step of applying solvent to the enclosure, internally or externally by a spray or other applicator means immediately prior to flushing the enclosure down the water closet.
Preferred examples of organic solvent soluble material forming the enclosure include polycaprolactone film and gelatinised starch film, both of which are soluble in the solvent N-methyl pyrrolidone. For this purpose, N-methyl pyrrolidone is a preferred solvent since it is not only very effective but also both biodegradable and non-inflammable.
According to a third major aspect of the present invention there is provided a water-dispersible disposable enclosure such as an ostomy pouch or urinary incontinence pouch, which enclosure is formed from a material that will dissolve or otherwise disperse in aqueous media as a result of salt replacement, the salt being applied to the external surface of the enclosure at the time of disposal into a water closet bowl. A particular preferred example of such material and salt are a film of calcium alginate that will dissolve in presence of aqueous sodium salt due to relative solubility of sodium alginate. Therefore, by providing sodium chloride in association with the disposable enclosure formed of calcium alginate, either stored in a pocket or sachet on the enclosure that is ruptured or dissolved at time of disposal or by independently applying then sodium salt to the enclosure at time of disposal, the sodium salt will dissolve in the water of the water closet bowl and replace the calcium of the calcium alginate film to render the enclosure cold water soluble.
Where the enclosure is an ostomy pouch it is suitably of the type which has a 2-part attachment to the wearer, having a base portion that semi-permanently mounts around the abdominal opening in the patient and a corresponding flange. on the pouch that cooperatively engages with the base portion, the flange being of a substantially rigid construction and in accordance with a further aspect of the present invention being formed of a rigid grade of the material of any of the previous aspects of the present invention, ie one which is meltable, soluble or dispersible as described herein above, or which is slowly cold-water soluble ie dissolves in co
Brown Malcolm David
Muncaster Barry John
Lewis Kim M.
Synnestvedt & Lechner LLP
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