GB2064333A

GB2064333A - Ostomy device

Info

Publication number: GB2064333A
Application number: GB8039448A
Authority: GB
Original assignee: GD Searle LLC
Current assignee: GD Searle LLC
Priority date: 1979-12-10
Filing date: 1980-12-09
Publication date: 1981-06-17
Also published as: GB2064333B

Abstract

An ostomy device (1) comprises an outer cover (2) of a non-woven material bonded by a radio frequency welded seam (3) to an inner impermeable pouch (4). The pouch (4) has a stoma-surrounding aperture (5) and the outer cover (2) has a slightly larger aperture (6). The edge of the pouch aperture (5) is radio frequency welded to a flange (7) of non-woven material. The material of the cover (2) and the flange (7) is non-dielectric and is not thermoplastic at the heat sealing temperature of the material of the inner <IMAGE>

Description

SPECIFICATION Ostomy device This invention relates to ostomy devices and to a composite element which may be used, for example, in ostomy devices.

Following ileostomy, colostomy and similar surgery it is usually necessary for the patient to wear an ostomy device which may be merely a cap to cover the stoma created in the operation or a socalled ostomy pouch to collect material discharged from the stoma. In either case the device is fre quentlysecured by an adhesive flange surrounding the stoma which may be additionally supported by a belt worn around the body.

Conventional ostomy devices are made from polyvinyl chloride, polyvinylidene chloride or polyethylene film material and the adhesive flange comprises a flange of the same plastic material coated with a suitable adhesive. It is a disadvantage of many of the adhesive flanges used in conjunction with conventional devices that both the flange and the adhesive are impervious to air and moisture with the result that the skin to which the flange is attached cannot 'breathe' and perspire normally with resulting discomfort to the patient, usually associated with skin irritation.

Attempts to overcome this disadvantage have been made by coating the plastic flange with a microporous adhesive. The use of the microporous adhesive does have the advantage that some permeability is established in the adhesive layer, ie. in a direction parallel to the face of the flange, but the benefit is only limited since the impermeable plastic flange itself prevents diffusion of air and moisture overthe greatest area of the flange, i.e. in a direction at right angles to the flange face.

It has been a feature of previous ostomy devices that both the device and its flange are made from the same plastic material and are heat sealed or welded together. Since it is essential that the material of the device shall be impervious to liquids and gases to ensure retention of the contents in the case of a pouch and to prevent escape of odour in all types of device, the problem of producing an adequately permeable flange has remained unsolved.

British Patent Specification No. 1470419 describes a stoma drainage bag formed from plastic film having an adhesive patch in associated with a stomasurrounding aperture, the adhesive patch being formed from a porous, air permeable, thermoplastic, weldable, woven or non-woven fabric provided on the skin-contacting face with discrete separated areas of a pressure-sensitive adhesive composition.

It is said in the specification that an advantage obtained from producing the adhesive patch from a porous, air permeable fabric is that the skin beneath the patch can 'breathe', at least in those areas not coated with the adhesive, and skin irritation is thereby reduced.

We have now found that the advantages of the stoma drainage bag of British Specification No.

1470419 can be achieved and even improved upon by using forthe adhesive patch (the flange) certain non-woven materials which are non-thermoplastic at the heat sealing temperature of the plastic film used for the main body of the device but can be united to plastic materials conventionally used to produce ostomy devices by radio frequency (RF) welding even though the non-woven material itself is not RF weldable, i.e. is not a dielectric. Such a flange can be coated with a microporous adhesive in such a way that it remains permeable to moisture and gases over its entire surface.

Accordingly, in a first aspect of the present invention there is provided an ostomy device comprising an aperture adapted to surround the stoma and associated with a flange whereby the device can be adhesively secured to the skin surrounding the stoma, wherein the device is made from an odour proof and liquid impermeable, plastic film material and is provided with a flange surrounding the aperture in the device, which flange is united to the device by radio frequency welding and is made from a porous non-woven fibre material in which neither the fibre nor any binder material used is a dielectric and is not thermoplastic at the heat sealing tempera- tu re of the plastic film material.

The flange can be so coated with a microporous adhesive that the pores in the fibre material are not substantially occluded.

This aspect of the invention is applicable not only to colostomy pouches but also to other ostomy devices such as stoma caps to be used where irrigation of the stoma is carried out.

The RF welding of the flange and the plastic film forming the device itself is carried out in conventional manner using a conventional RF welding electrode and, surprisingly, a good bond is obtained in spite of the fact that the material of the flange does not have the physical characteristics normally required for RF welding. Preferred RFweldable plastic materials for the main body of the device are ethylene vinyl acetate film (heat sealing temperature 65 to 85"C); polyvinylidene chloride/polyvinyl chloride copolymer film (heat sealing temperature 90 to 110 C) or plasticised polyvinylchloride film (heat sealing temperature 100 to 1 500C) or laminates thereof, for example a layer of polyvinylidene chloride sandwiched between two layers of ethylene vinyl acetate.

The term non-woven fibre material is intended to cover any non-woven material made from fibres, with or without a binder, where neither the fibre nor any binder is a dielectric. It is preferred that the material (or any of its components) shall not be thermoplastic at temperatures below 200 C. Specific examples are materials made from polyester fibres or cellulose fibres, for example viscose rayon fibres. Suitable binders, where used, are cross-linked latices of styrene-butadiene, polyisoprene or acrylic polymers.

The fabrics can be spunlaced or wet or dry laid using a binder.

The drawing(s) originally filed were informal and the print here reproduced is taken from a later filed formal copy.

Any of the microporous adhesives used in conjunction with present ostomy devices can be coated onto the flange.

Processes for applying microporous adhesives to porous fabrics so as to retain the porosity of the fabric are known. U.K. Patent 987,933 describes coating onto a release paper as adhesive composition in a volatile solvent, evaporating off a proportion of the solvent, applying the coated surface of the release paper to the desired fabric, peeling off the release paper and evaporating off the remainder of the sol- vent from the coated fabric with the result that the adhesive shrinks back onto the fibres of the fabric leaving the pores not substantially occluded.

As previously stated the main body of an ostomy device, for example the pouch, needs to be made from a gas and liquid impermeable material, usually a polyvinyl chloride, polyvinylidene chloride or polyethylene film. However, such materials have the disadvantages in use that, being impermeable to liquids, they become damp as a result of condensation onto their surfaces of moisture and perspiration and at least when initially positioned feel unpleasant against the skin. In addition, the material may emit an embarrassing rustle when flexed.

Attempts have been made to overcome these disadvantages by enclosing the device in a removable fabric covering but this is not entirely satisfactory since the separate fabric cover and the means needed to secure it increase the bulk of the device and complicate its fitting.

In order to ensure a fluid and odour-proof appliance, it has been considered necessary to form the device by heat-sealing or welding the edges of plastic film in the desired shape and it has not, therefore, been possible, except with the use of adhesives, which wou Id greatly complicate manufacture, to make a pouch with an integral cover.

According to another aspect of the invention there is provided an ostomy pouch comprising a drainage pouch made from two sheets of a liquid and odour impermeable plastic film material capable of radio frequency welding and a cover for the pouch made from one or two sheets of a woven or non-woven fibre material in which the fibre and any binder used is non-dielectric, the film and the one or two sheets of fibre material being all united together at their edges with a radio frequency welded seam.

Two pieces of the woven or non-woven material are used when it is desired to provide an overall coverforthe pouch, one is used when a covering is to be provided only on the patient side of the pouch.

The pouch according to this aspect of the invention has the advantage that its feel against the skin is acceptable and the rustle associated with the plastic material of the device is greatly reduced.

In one form of this aspect of the present invention there is provided an ostomy pouch comprising a main body made from an odour-proof and liquid impermeable plastic film material capable of radio frequency welding and provided with an aperture adapted to surround the stoma, a flange surrounding the aperture and made from a non-woven fibre material and a covering on at least one side of the main body made from a woven or non-woven fibre material wherein the woven or non-woven fibre material is made from fibres, and if desired a binder in the case of non-woven material, which are not dielectric and are not thermoplastic at the heat sealing temperature of the film, and the flange and the cover are united to the plastic material by radio frequency welding.

It should further be mentioned that the reduction in rustle provided by this aspect of the presentinven- tion can be used to advantage in the production of liquid impermeable undergarments for use in incontinence.

In another aspect thereof, the invention relates to a composite element comprising a layer of an odour and liquid impermeable film material united with a moisture absorbent layer. The invention is particularly concerned with articles and materials for medical use.

It is frequently desirable that 'textile' materials for medical use shall be both odour and liquid impermeable but that they shall also be moisture absorbent and have a pleasant feel. Conventionally this combination of properties may be achieved in relation to some articles by using a flock coated plastic film by producing a laminate of two or more layers of material adhesively bonded or sewn together. These method of fabrication have many disadvantages. Flock coating requires complex and expensive equipment and produces a material of only limited water absorption on the flocked side.

Lamination by adhesive bonding or sewing is complicated, particularly where complex shaped are required.

According to this aspect of the invention there is provided a composite element comprising at least one sheet of a liquid and odour impermeable plastic film material capable of radio frequency welding bonded at its edges or in discrete separated areas to one or more sheets of a woven or non-woven fibre material in which the fibre and any binder used are non-dielectric.

Using this aspect of the invention a composite material having the desired properties can be produced easily and economically, even when complex shapes are required. Using the conventional process of radio frequency welding (RF welding) the materials are surprisingly securely bonded together at the weld, in spite of the fact that the fibre material is itself a non-dielectric and therefore would not be expected to be RF mveidable. The use of a conventional RF welding electrode makes possible the production of the composite material according to the invention in any desired size and shape, including the provision of vents and apertures in the material where desired.

The composite elements provided by this aspect of the invention can take the form ole, for example, of disposable operation drapes, gowns and hoods, disposable bedding sheets and garments. The invention has applicability for any use where odour and/or liquid impermeability moisture absorbence and a pleasant handle are required. Any polymeric film material which is odour and liquid impermeable and can be RF welded can be used as one layer of the composite element. Suitable examples are films made from ethylene vinyl acetate, polyvinylidene chloride/polyvinyl chloride copolymer, plasticised polyvinyl chloride and laminates thereof.

The only requirements for the woven or nonwoven fibre material is that it shall be made from a non-dielectric fibre and that any binder present shall also be non-dielectric. Non-woven materials are preferred for cost reasons. Examples of suitable materials are those made from polyester fibres or cellulose fibres, for example viscose rayon fibres. Examples of suitable binders for use particularly with non-woven materials are latices of styrene-butadiene, polyisoprene or acrylic polymers. Where a non-woven material is used it can be produced by spunlacing or wet or dry laying using a binder.

The composite elements of this aspect of the invention are produced by placing the plastic film and the fibre material in face to face relationship and bonding them together by application in known manner of an RF welding electrode along their edges and/or in any other desired positions.

The invention is particularly suitable for the production of apertured surgical operation drapes, the apertures of window in the drap having the plastic film and the fibre material sealed together at its edges by RF welding.

The principle of this aspect of the invention also has application in the production of ostomy devices, and more particularly ostomy pouches, as will be apparent from what has been said above.

The invention is further illustrated by the accompanying drawings in which: Figure 1 is a view of an ostomy bag according to the invention provided with a flange and an overall covering of the non-woven fibre material and Figure 2 is a section on a larger scale, along the line A-A of Figure 1.

Referring now to the drawings, the pouch 1 comprises an outer cover 2 of a non-woven material, for example, polyester material (Sontara - E. I. DuPont de Nemours) or cellulose-based material, bonded by an RF welded seam 3 to an inner impermeable pouch 4 of a polyvinylidene chloride copolymer. The material of the outer cover is non-dielectric and is not thermoplastic at the heat sealing temperature of the material of the inner pouch 4.

The pouch is provided with a stoma-surrounding aperture 5 and the outer cover 2 is provided with a corresponding, slightly larger aperture 6. The edge of the pouch aperture 5 is RF welded to a flange 7 produced from the same material as the outer cover.

In the finished article the face of the flange 7 is coated with a layer of microporous adhesive protected by a removable non-adhesive cover layer such as siliconised paper. The base 8 of the pouch may be permanently sealed by an RF welded seam or it may be provided with a re-sealable closure so that the pouch can be emptied.

Claims

1. An ostomy device comprising an aperture adapted to surround the stoma and associated with a flange whereby the device can be adhesively secured to the skin surrounding the stoma, wherein the device is made from an odour proof and liquid impermeable, plastic film material and is provided with a flange surrounding the aperture in the device, which flange is united to the device by radio frequency welding and is made from a porous nonwoven fibre material in which neither the fibre nor any binder material used is a dielectric and is not thermoplastic at the heat sealing temperature of the plastic film material.

2. A device according to claim 1, wherein the non-woven fibre material is a spunlaced material.

3. A device according to claim 1 or 2, wherein the non-woven fibre material is a polyester or cellulose material.

4. A device according to claim 1,2 or 3, wherein the said plastic film material is selected from ethylene vinyl acetate, polyvinylidene chloride/polyvinyl chloride copolymer, plasticised polyvinylchloride, and laminates thereof.

5. An ostomy pouch comprising a drainage pouch made from two sheets of a liquid and odour impermeable plastic film material capable of radio frequency welding and a coverforthe pouch made from one or two sheets of a woven or non-woven fibre material, in which the fibre and any binder used is non-dielectric, the film and the one or two sheets of fibre material being all united together at their edges with a radio frequency welded seam.

6. An ostomy pouch comprising a main body made from an odour-proof and liquid impermeable plastic film material capable of radio frequency welding and provided with an aperture adapted to surround the stoma, a flange surrounding the aperture and made from a non-woven fibre material and a covering on at least one side of the main body made from a woven or non-woven fibre material wherein the woven or non-woven fibre material is made from fibres, and if desired a binder in the case of nonwoven material, which are not dielectric and are not thermoplastic at the heat sealing temperature of the film, and the flange and the cover are united to the plastic material by radio frequency welding.

7. A device according to claim 5 or 6, wherein the fibre material is a spunlaced material.

8. A device according to claim 5, 6 or 7, wherein the fibre material is a polyester or cellulose material.

9. A device according to any one of claims 5 to 8, wherein the said plastic film material is selected from ethylene vinyl acetate, polyvinylidene chloride/polyvinyl chloride copolymer, plasticised polyvinylchloride, and laminates thereof.

10. An ostomy device substantially as herein described with reference to the accompanying drawings.

11. A composite element comprising at least one sheet of a liquid and odour impermeable plastic film material capable of radio frequency welding bonded at its edges or in discrete separated areas to one or more sheets of a woven or non-woven fibre material in which the fibre and any binder used are non-dielectric.

12. An element according to claim 11, wherein the fibre material is a spunlaced material.

13. An element according to claim 11 or 12, wherein the fibre material is a polyester or cellulose material.

14. An element according to claim 11, 12 or 13, wherein the said plastic film material is selected from ethylene vinyl acetate, polyvinylidene chloride/polyvinyl chloride copolymer, plasticised polyvinylchloride, and laminates thereof.