WO2010122347A1

WO2010122347A1 - Ostomy pouch material

Info

Publication number: WO2010122347A1
Application number: PCT/GB2010/050662
Authority: WO
Inventors: Phillip Arthur Hadley
Original assignee: Phillip Arthur Hadley
Priority date: 2009-04-24
Filing date: 2010-04-23
Publication date: 2010-10-28
Also published as: GB2469686A; GB2469686B; GB0907051D0

Abstract

A material (10) for the manufacture of an ostomy pouch, including a plurality of layers, including a degradable layer (12) which is sandwiched between a first, inner layer (14) and a second, outer layer (16), a portion of the second, outer layer (16) being separable from the degradable layer (12), to expose at least a part of the degradable layer (12) to a degrader, such that in use the material (10) is inhibited from degradation until the degradable layer (12) is exposed. This is intended to speed up the degradation process after disposal of an ostomy pouch manufactured from the material (10).

Description

Title: Ostomy Pouch Materia!

Description of Invention

This invention relates to a material suitable for use in the manufacture of ostomy pouches, and to ostomy pouches manufactured from such material.

it is known in the art to provide ostomy pouches of durable water resistant materials, such as a PVC material so the ostomy pouch is able to be used in the shower, for example, and so the pouch adequately performs its primary function, to contain waste.

An outer surface, or at least the part of an outer surface of the pouch which is, in use, intended to come into contact with the skin of the user, is generally covered with a comfortable layer, which may be dimpled or perforated, to avoid the materia! inadvertently adhering to the user's skin.

A disadvantage of manufacturing ostomy pouches from such durable materials is that the pouch is difficult to dispose of. If the pouch is disposed of in a waste bin, the pouch generally ends up at a landfill site, and the PVC material takes a long time to degrade, if ever doing so. If the pouch is disposed of in a lavatory, the PVC can cause blockages of domestic and municipal drainage systems.

According to a first aspect of the present invention, there is provided a material for the manufacture of an ostomy pouch, including a plurality of layers, including a degradable layer which is sandwiched between a first, inner layer and a second, outer layer, a portion of the second outer layer being separable from the degradable layer, to expose at least a part of the degradabie layer to a degrader, such that in use the material is inhibited from degradation until the degradable layer is exposed,

An advantage of this materia! is that the ostomy pouch does not degrade during use, and is water resistant, by virtue of the properties of the inner and outer layers. Liquid in the waste contained within the pouch is unable to come into contact with the degradabie layer by virtue of the inner iayer, and the pouch is shower proof, by virtue of the outer layer. Thus the inner and outer layers maintain the integrity of an ostomy pouch manufactured from the material before and during use.

The degradable layer preferably provides a major proportion of the material, such that exposing the degradable iayer to a degrader, for example liquid or light, causes a major proportion of the material, to degrade.

The properties of the degradabie layer are such that once the degradabie iayer has been exposed to a degrader, degradation begins instantaneously, taking a relatively short time, of the order of minutes or hours, for the degradable layer to completely degrade. The voiume of material remaining after the degradable layer has degraded is small compared with the original volume of material present, and compared with the volume of durable material present in conventional ostomy pouches.

The degradabie layer may be attached to each of the inner and outer layers by a water-soluble adhesive, such that once the water-soluble adhesive is exposed to the degrader, the material wil! begin to disintegrate. Even in the event that the degradabie layer is covered by adhesive when the user attempts to expose the degradable layer, the solubility of the adhesive means that the degradable layer will be exposed to the degrader in due course. The second, outer layer may be covered with a protective, water-resistant layer. The protective layer may be more suitabSe for skin contact. The protective layer may be a "comfort" layer, which is suitable for prolonged contact with the skin. This protective layer may be manufactured from a water-resistant, yet breathable material. The protective layer further inhibits inadvertent and undesired degradation of the materiai during use of a pouch manufactured from the material.

At least a portion of the protective layer may be separable from the materiai. The separable portion of the protective layer and may be adhered to the second outer layer by a bond which is stronger than that between the outer layer and the degradabie layer, such that the separable portion of the second layer is separable from the degradabie layer and the inner layer along with the separable portion of the protective layer. The separable portion of the outer layer is removed quickly and simply, by removal of the separable portion of the protective layer. The protective layer may have a skirt or grip portion, which is easily graspabie, and hence is easily separable from the remainder of the material.

The degradabie layer may be water-soluble, such that an ostomy pouch manufactured from the materiai is disposable in a lavatory, i.e. "flushable", without leading to blockage of drains, etc. which is a problem encountered if ostomy pouches manufactured from conventional materials are disposed of in a lavatory.

The degradabie layer may include a layer of water-soluble polyvinyl alcohol foam. Foamed polyvinyl alcohol is more quickly dissolved on contact with water than non-foamed polyvinyl alcohol, owing to its increased surface area,

The degradabie layer may include a dye for colouring water. This dye may indicate when the foam has been contacted by water and has begun to degrade, for example to indicate that the material, or more particularly an ostomy pouch manufactured from the material, may be flushed away.

The degradable layer may be compostable. !n the event that an ostomy pouch manufactured from the material ends up on a landfill site, for example through being discarded in a waste bin, the materia! will degrade more quickly than the materials from which ostomy pouches are conventionally manufactured, for example over a period of weeks, up to a maximum of six months.

At least one of the first, inner layer and the second outer layer may be degradable. The or each of the first and second layers may be biodegradable or compostable for examples, such that each of the inner and outer layers is degradable over a longer period of time than the degradable layer. For example, at least 90% of the each of the first inner layer and the second, outer layer may be converted into carbon dioxide within six months when exposed to micro-organisms, moisture, nitrogen and oxygen. Thus, whilst the integrity of the pouch is maintained before and during use, once a pouch manufactured from the material has been discarded, the entire pouch will disintegrate more quickly than a pouch manufactured from conventional materials.

At least one of the layers of the material may include an antibacterial agent. This inhibits or prevents the proliferation of bacteria, and reduces the likelihood of infection during use of a pouch made from the material.

According to a second aspect of the invention, there is provided an ostomy pouch manufactured from materia! according to the first aspect of the invention, such that the pouch is inhibited from degrading during use, but at least a major proportion of the pouch is degradable once the degradable layer has been exposed to a degrader. A major proportion of the pouch may be water-soluble, such that the pouch may be disposed of in a lavatory, and a major proportion of the ostomy pouch is degradable within a few hours from exposure to a degrader. Alternatively, the pouch may be biodegradable, such that the pouch degrades within a maximum of six months.

The pouch may include a degradable filter and/or a degradable wafer, such that the entire pouch is degradable.

The invention will now be described, by way of example only, with reference to the accompanying drawings, of which:

FIGURE 1 is an illustrative cross sectional view of each side of an ostomy pouch manufactured from the material of the present invention,

FIGURE 2 is an exploded, illustrative view of one side of an ostomy pouch, showing each of the layers of material,

FIGURE 3 shows the approximate relative thicknesses of each of the layers of the material, and

FIGURE 4 shows an ostomy pouch manufactured from an alternative embodiment of the material of the present invention.

Referring to the figures there is shown a material 10 which is suitable for use in the manufacture of ostomy pouches.

The material 10 includes a degradable layer 12, which is sandwiched between a first, inner layer 14 and a second, outer layer 16. The degradable layer 12 is, in this example, a film of polyvinyl alcohol. Polyvinyl alcohol is water- soluble, generally within a period of minutes, up to a few hours, depending upon the thickness of the film and the characteristics of the water acting as a solvent, for example the type, volume, temperature and motion of the water.. As an alternative to the degradable layer 12 being a water-soluble film, it may be a photodegradable or biodegradable material. The degradable layer 12 may be compostable.

The first, inner layer 14 is water resistant, so as to be suitable for forming an inner surface of an ostomy pouch. The second outer layer 16 is also water- resistant so as to protect the degradabie layer 12 from degradation before and during use. Each of the inner and outer layers 14, 16 is a polymer. In this example the inner and outer layers are extruded films of an organic, i.e. food- based, polymer. The polymer is preferably polyiactic acid. However, as an alternative, the polymer may be a blend of polyethylene and potato starch. Whilst the integrity of each of the inner and outer layers 14, 16 is maintained during use, and each of the layers 14, 16 is water resistant to an extent, the inner and outer layers 14, 16 are degradable in the medium to long term, for example over a period of several weeks, up to six months. Each of the inner and outer layers 14, 16 is preferably compostable {degrading into carbon dioxide and biomass), biodegradable or photodegradable. Thus, prolonged exposure to an appropriate degrader will cause the degradation of the inner and outer layers 14, 16. The inner and outer layers 14, 16 preferably degrade over a period of approximately four to six weeks.

The outer layer 16 includes an aperture 17. A separable portion 16a of the outer layer 16 covers and seals the aperture 17 and is separable from the remainder of the outer iayer 16. The separable portion 16a of the outer layer 16 may be attached to the remainder of the outer layer 16 by a quantity of water-soluble adhesive 18c. The degradable layer 12 is attached to each of the inner and outer layers 14, 16 by a water-soluble adhesive 18a, 18b. The layers 12, 14, 16 and 18 are extruded together.

The thickness of the degradable layer 12 is approximately 73% to 90% of the thickness of the material 10, preferably approximately 80%, Each polymer layer 14, 16 accounts for approximately 2% to 6%, preferably approximately 4% of the thickness of the material 10, and each layer of adhesive 18 is approximateiy 1% to 3%, preferably approximately 2% of the thickness of the materia! 10.

In this example, the outer iayer 16 is covered by a protective iayer 20. The protective layer 20 is comfortable to wear adjacent the skin and also assists in protecting the other layers of the materia! 10. The protective layer 20 may also be an organic, e.g. potato starch-based polymer, and hence is breathable, but is eventually degradable, over a similar period of time to the Inner and outer layers 14, 16, for example approximately four to six weeks.

The layer 20 also includes an aperture 21 which is sealed by a portion 20a of the same material as the remainder of the layer 20. The portion 20a of the protective iayer 20 is attached to and is separable from the remainder of the protective layer 20. The edges of the separable portion 20a may abut corresponding edges of the aperture 21 in the layer 20. Alternatively, the separable portion 20a is slightly larger than the aperture 21 in the layer 20, such that the separable portion 20a completely covers and overlies a part of the remainder of the layer 20, In the latter case, the part of the separable portion 20a which overlaps the layer 20 forms a skirt of material which is easily graspable between the fingers of one hand, so as to aid the separation of the separable portion 20a from the remainder of the material 10. Each of the separable portions 16a, 20a is an elongate strip, as this is the most straightforward arrangement to produce when extruding the material 10. Alternatively the separable portions 16a, 20a may be any other shape as desired, for example each may be a patch which is surrounded on all sides by the remainder of the respective layer 16, 20 of material.

The protective layer 20 is attached to the outer layer 16 of the material 10, for example by a hot-melt adhesive 22. The separable portion 1δa of the outer layer 16 and the separable portion 20a of the protective layer 20 are also adhered to one another. The adhesive 22 is applied in strips which extend along the material 10, between the outer iayer 16 and the protective layer 20. Alternatively, the adhesive may be applied in dots, or in any other desired configuration. The bond between the separable portion 20a of the protective layer 20 and the separable portion 16a of the outer layer 16 is stronger than that between the outer layer 16 and the degradabie layer 12 which is formed by the water-soluble adhesive 18b. The protective layer 20 is incorporated into the material 10 as a separate manufacturing step from the extrusion process.

At least one of the layers 12, 14, 16, 20 of the materia! 10 optionally includes an antibacterial agent. In particular, the protective layer 20 preferably includes an antibacterial agent. An example of a suitable antibacterial agent is BioSilver (TM).

At least one of the layers, preferably the degradabie layer 12, includes a fragrance, for example to neutralise the odour of the polyvinyl alcohol.

In use, two sheets of the material 10 are arranged back to back, and are welded together to form an ostomy pouch, as shown in Figure 1 , The weid extends around the edges of the ostomy pouch, in a conventional manner such that the pouch is sealed. Alternatively a single sheet of material 10 could be folded, to form two sides of an ostomy pouch, with the open sides being welded together to form a sealed pouch. The ostomy pouch may be any shape or size as required.

The inner layers 14 of the two sheets of material 10 form an inner surface of the ostomy pouch, and retain ail waste products within the pouch, without the pouch degrading whilst in use. The degradable layer 12 is sandwiched between the inner layer 14 and the outer layer 16 and is shielded from coming

Into contact with liquid by these layers 14, 16 during use. The protective layer

20 provides comfort to the user of the ostomy pouch and also provides a further protective layer for the degradable layer 12. The protective layer 20 may extend over the entire outer surface of the outer layer 16, and hence over the entire outer surface of the ostomy pouch.

A wafer 24 is provided, which provides an adhesive seai for attachment of the ostomy pouch to the user's body. The wafer 24 is attached to the outer surface of the ostomy pouch, outside the protective layer 20. A part of the wafer 24 may extend through the materia! 10, to the inner layer 14 of the material 10, to support an opening in the ostomy pouch for receiving a user's stoma.

The wafer 24 may be adaptable in size. The wafer 24 may be of the kind which provides a one-piece or two-piece ostomy pouch. Irrespective of whether the pouch is one-piece or two-piece, the wafer 24 is aiso manufactured from degradabie material, for example polylactic acid. Thus, the wafer 24 is likely to degrade within four to six weeks in appropriate conditions, up to a maximum of six months. The wafer 24 may also include an antibacterial agent.

A filter, for example a carbon filter, may be provided in the pouch, to filter gases which are released from the pouch. The filter is preferably contained in a capsule of degradable material, for example a water-soluble film or compostable film.

An ostomy pouch manufactured from the material 10 will not degrade during use. The ostomy pouch may be exposed to liquid, for example during showering, and the pouch material 10 wiil not degrade. The dβgradable layer

12 is protected from contact with liquid by the inner and outer layers 14, 16, which retain their integrity for long enough when in contact with liquid for the pouch to remain intact during use. Until the degradabie layer 12 is exposed to a degrader, by the removal of the separable portion 16a of the protective layer

16, the degradabie layer is inhibited from degrading, such that the integrity of the material 10, and therefore the pouch, is maintained.

When the ostomy pouch is to be discarded, the user peels back the separable portion 20a from the protective layer 20. Since the bond between the separable portion 20a of the protective layer and the separable portion 16a of the outer layer 16 is stronger than the bond formed by the water-soluble adhesive 18 between the outer layer 16 and the degradable layer 12, the separable portion 16a of the outer layer 16 is separated from the remainder of the outer layer 16. Thus, the aperture 17 is exposed. The separable portions

16a, 20a may be completely separated from the remainder of the material 10, or may simply be peeled back, so as to remain partially in contact with the remainder of the material 10. In the event that the separable portion 20a is attached to the wafer 24, simply detaching the pouch from the wafer 24, as is known in the art, can cause the separable portion 20a of the protective layer, and hence the separable portion 16a, to separate from the remainder of the material 10.

This separation of the separable portion 16a from the remainder of the outer layer 16 causes an area of water-soluble adhesive 18 to be exposed. If the degradable layer 12 is a water-solubie materia!, and the pouch is disposed of in a lavatory, water is abie to permeate through the material 10, dissolving the water-soluble adhesive 18 and the degradabie layer 12. The degradable layer 12 accounts for a major proportion of the volume of the material 10, such that once the degradable layer 12 is exposed, the majority of the ostomy pouch begins to disintegrate virtually instantaneously, and preferably compieteiy disintegrates within a few hours. Thus even If the inner and outer layers 14, 16 are non-degradable (which term encompasses materials which never degrade, and those which degrade over a very long period of time, in the order of several years), the amount of non-degradable material remaining after exposure of the degradable material is very smali compared with the volume of materia! 10 originally used to provide an ostomy pouch of adequate strength and durability to fulfil its primary purpose, i.e. to contain waste.

In this example, the material from which the inner and outer layers 14, 16 are manufactured is also degradable. Each of the layers 14, 16 is preferably biodegradable or compostable, such that once exposed to micro-organisms, oxygen, nitrogen and moisture, the layers 14, 16 degrade within a maximum of six months, preferably between four to six weeks. Therefore all of the layers of the material 10, including the separable portions 16a, 20a, are degradabie.

!n the event that the wafer 24 and the capsule which encloses the filter are manufactured from a water-soluble or other degradabie material, the entire pouch is degradable within a maximum time period of six months.

In the event that the degradable layer 12 is water-soluble, once the degradable layer 12 has been exposed to a degrader, the majority of the material 10, provided by the degradable layer 12, and the adhesive 18 begins to degrade instantaneously, and preferably completely degrades within minutes or hours. The inner and outer layers 14, 16, the protective layer 20 and the additional parts of the ostomy pouch, e.g. the wafer 24 and the filter will degrade within a maximum of six months, preferably within four to six weeks. A second embodiment of the materia! is shown at 110 at figure 4. Ail features of the second embodiment of the material 110 which correspond with equivalent features of the first embodiment of the material 10 are referred to with corresponding reference numerals, prefixed with i'.

The general structure of the material 110 is similar to that of the material 10, in that it includes a degradable layer 112 sandwiched between a first, inner layer 114 and a second, outer layer 116, The edges of the inner, outer and degradable layers 114, 116, 112 are thermally sealed. The outer layer 16 is manufactured from a non-solubie or bio-degradable polymer and includes an aperture 116 covered and sealed by a separable portion 116a of the outer layer 116. The outer layer 116 is covered by a protective layer 120 which is manufactured from a non-soluble or bio-degradable polymer and has an aperture 121 which is covered and sealed by a separable portion 120a of the protective layer 120.

In this embodiment of the materia! 110, the degradabie layer 112 includes a layer of polyvinyl alcohol foam 128 and a pair of layers of polyvinyl film 130, The polyvinyl alcohol foam layer 128 is sandwiched between the layers of polyvinyl film 130. Both the polyvinyl alcohol foam 128 and the polyvinyl alcohol fϋm layers are coϊd-water-solubie and are attached to the inner and outer layers 114 and 116 by cold-water-soluble adhesive PVA film 118.

The foam layer 128 forms approximately 50% to 90% of the thickness of a sheet of the material 110. The material 110 is extruded and then separated to enable the foamed polyvinyl alcohol 128 to be included in the composition.

The foam layer 128 is more quickly degradable than non-foamed polyvinyl alcohol degradable layer 12. Foaming the polyvinyl alcohol creates a larger surface area to absorb water, to dissolve the layer 128 so as to degrade the degradable layer 112.

The foam layer 128 may include a coloured dye which acts as an indicator to the user. For exampie, on removing the separable portion 120a of the protective layer 120 and placing a pouch manufactured from the material 110 in water, for exampie by placing in a lavatory for disposal, water may require a short time to come into contact with the foam iayer 128. Upon water coming into contact with the dyed foam layer 128, dye may be released from the foam layer, colouring the water in the lavatory. This provides a visible indication to the user that the pouch has begun to degrade, and that it is permissible to flush the lavatory, in the knowledge that the degradation process will continue.

in a third, alternative embodiment of the material each of the inner and outer layers 14, 16, 114_» 116 is manufactured from cold-water-resistant hot-water- soluble polyvinyl alcohol rather than polylactic acid. An advantage of using such a materia! is that the coid-water-resistant hot-water-soluble polyvinyl alcohol material softens more readily than polylactic acid, Cold-water-resistant hot-water-soluble polyvinyl alcohol material would be resistant to degradation during use, i.e. waste products in contact with the inner layer 14, 114 would not cause the material to degrade. However, the outer layer 16, 116 would have to be completely covered by the protective layer 20, 120 to enable an ostomy pouch manufactured from this version of the material to be usable in the shower.

Non-soluble adhesive tape 26, 126 including non-soluble film coated with a non-soluble adhesive, may be applied to the protective iayer, to sea! the junction between the separable portion 20a, 120a, and the remainder of the protective layer 20, 120 to facilitate bathing and swimming without the material 10, 110 degrading. The adhesive tape 26, 126 should be removed before disposal, to enable removable of the separable portion 20a, 120a. In the event that the degradable layer 12, 112 is compostable, photodegradable or biodegradable, rather than water-soluble, the pouch can be discarded by placing in a waste bin, The most likely destination of the pouch wil! then be a landfill site, and since the majority of the material 10, 110 from which the pouch is manufactured is provided by the degradable layer 12, 112 the entire pouch will degrade more quickly than a pouch manufactured from conventional durable materials, for example within a maximum of six months.

The features disclosed in the foregoing description, or the foliowing claims, or the accompanying drawings, expressed in their specific forms or in terms of a means for performing the disclosed function, or a method or process for attaining the disclosed result, as appropriate, may, separately, or in any combination of such features, be utilised for realising the invention in diverse forms thereof.

Claims

1. A material for the manufacture of an ostomy pouch, including a plurality of layers, including a degraciabie layer which is sandwiched between a first, inner layer and a second, outer layer, at least a portion of the second, outer layer being separable from the degradable iayer, to expose at least a part of the degradable iayer to a degrader, such that in use the material is inhibited from degradation until the degradable layer is exposed.

2. A material according to claim 1 wherein the degradable layer provides a major proportion of the material.

3. A material according to claim 1 or claim 2 wherein the degradable layer is degradable within a time period of the order of minutes or hours.

4, A material according to any of the preceding claims wherein the degradabie layer is attached to each of the inner and outer layers by a water- solubie adhesive.

5. A material according to any of the preceding claims wherein the second, outer layer is covered with a protective, water-resistant layer.

6. A material according to claim 5 wherein the protective layer is suitable for skin contact.

7. A material according to claim 5 or claim 6 wherein at least a portion of the protective layer is separable from the material.

8. A material according to claim 7 wherein the protective layer is adhered to the second outer layer by a bond which is stronger than that between the outer layer and the degradable layer, such that the separable portion of the second layer is separable from the degradable layer and the inner layer along with the separable portion of the protective layer.

9. A material according to any one of the preceding claims wherein the degradable layer is water-soluble.

10. A material according to claim 9 wherein the degradable layer includes a layer of water-soluble polyvinyl alcohoi foam.

11. A material according to claim 9 or claim 10 wherein the degrable layer includes a dye for colouring water.

12. A material according to any one of claims 1 to 8 wherein the degradable layer is compostable.

13. A material according to any of the preceding claims wherein at least one of the first, inner layer and the second outer layer is long-term degradable.

14. A material according to claim 12 wherein the or each of the first and second layers is biodegradable.

15. A material according to any of the preceding claims wherein at least one of the layers of the material includes an antibacterial agent.

16. A material substantially as described herein and/or as shown in the accompanying drawings.

17. An ostomy pouch manufactured from material as claimed in claims 1 to 16 such that the pouch is inhibited from degrading during use, but at least a major proportion of the ostomy pouch is degradabie once the degradable layer has been exposed to a degrader.

18. An ostomy pouch according to claim 17 wherein a major proportion of the pouch is water-soluble.

19. An ostomy pouch according to claim 17 or claim 18 wherein a major proportion of the ostomy pouch is degradable within a time period of the order of minutes or hours of the degradable layer being exposed to a degrader.

20. An ostomy pouch according to any one of claims 17 to 19 wherein at least a proportion of the pouch is biodegradable.

21. An ostomy pouch according to any one of claims 17 to 20 including a degradabie filter.

22. An ostomy pouch according to any one of claims 17 to 21 including a degradable wafer.

23. An ostomy pouch substantially as shown herein and/or as shown in the accompanying drawings.

24. Any novel feature or any novel combination of features substantially as shown herein and/or as shown in the accompanying drawings.