Ostomy bags

Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...

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Details

604332, A61F 544

Patent

active

057761205

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 application of PCT/GB95/01423 filed Jun. 19, 1995.


BACKGROUND OF THE INVENTION

The present invention relates to laminar structures, and in particular ostomy bags incorporating such laminar structures.
Ostomy bags for receiving bodily waste from colostomy and ileostomy patients are well known and a major problem with such bags is that it can be difficult to dispose of the used bag in a convenient and hygienic manner. A known approach to this problem has been to make the ostomy bag from a material which degrades or dissolves in water and can therefore be flushed down a W.C. bowl after use. One material which has been employed for this purpose is a polymeric film formed from polyvinylalcohol/ polyvinylacetate (PVA). As is generally known, the water-solubility of a particular grade of PVA will depend upon the extent of hydrolysis of the ester groups in the polymer, the water solubility in general increasing with the number of free hydroxyl groups in the polymer. Thus it is possible to obtain grades of PVA which are readily soluble in hot water but remain insoluble over a period of several days (i.e. for the maximum time over which an ostomy bag would normally be worn) in cold water. Such hot water-soluble grades of PVA can be used to form ostomy bag liners which have the advantage that over a more prolonged period, they are biodegradable.
However, although disposable ostomy bags formed of PVA have been found to perform well, it has also been found that it is somewhat difficult to provide a secure attachment between the PVA bag wall and the material of the adhesive flanges typically used to attach ostomy bags to the abdomens of patients. In particular, where moisture is allowed to come into contact with the PVA bag wall in the region of the bond between the PVA wall and the adhesive flange, the moisture has a tendency to destroy the bond, leading to the bag wall and adhesive flange becoming detached.
It is an object of the present invention to overcome or at least alleviate this problem.


SUMMARY OF THE INVENTION

It has now been found that by interposing a layer of a water-impermeable water-insoluble material between the PVA bag wall and adhesive flanges, and by bonding the water-impermeable, water-insoluble material to the PVA bag wall by means of a cyanoacrylate adhesive, the aforementioned problem can be overcome.
Accordingly, in a first aspect, the invention provides a drainage bag, such as an ostomy bag or like drainage bag, for receiving bodily waste, the drainage bag having a wall portion formed of a water-softenable or hot-water-soluble first film material, the wall portion having an opening therein for receiving the bodily waste or bodily fluid; a water-impermeable, water-insoluble polymeric film material being adhered to the outer surface of the said wall portion so as to surround said opening, the water-impermeable, water-insoluble layer being adhered to the said wall portion by means of a cyanoacrylate layer interposed therebetween; and the outer surface of the water-impermeable, water-insoluble layer having secured thereto an adhesive flange for securing the drainage bag to the body wall of a patient.
The water-softenable or hot-water-soluble film is one which has negligible solubility at room temperature (25.degree. C.), is slowly soluble at around 38.degree. C. over a period of at least two days, but which disintegrates within less than 60 minutes, preferably less than 30 minutes at water temperatures in excess of 50.degree. C.
The water-softenable or hot-water-soluble first film material is preferably a film formed from polyvinylacetate/polyvinylalcohol. One particularly suitable PVA film material is the 30 .mu. thick PVA film marketed under the reference code EC600 by NEDI of Middlewich, Cheshire, UK. Such film dissolves or disintegrates within 30 seconds at 50.degree. C. in water, but at 38.degree. C. is only very slowly soluble, and at room temperature is reasonably stable. This particular film is not only soluble in hot water, but is also degraded by bacteria r

REFERENCES:
patent: 4203445 (1980-05-01), Jessup et al.
patent: 4230761 (1980-10-01), Watts
patent: 5108382 (1992-04-01), Wright et al.

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