WO2006077438A1

WO2006077438A1 - Ostomy bag

Info

Publication number: WO2006077438A1
Application number: PCT/GB2006/000232
Authority: WO
Inventors: Rory James Maxwell Smith; Paul Bird; Richard Patrick Finn
Original assignee: Welland Medical Limited
Priority date: 2005-01-24
Filing date: 2006-01-24
Publication date: 2006-07-27
Also published as: GB2422312B; GB2422312A; GB0501400D0

Abstract

The invention provides a drainage bag assembly for receiving bodily waste; the drainage bag assembly comprising outer (6) and inner (12) bags secured to one side of a flange (2), the flange (2) being provided with means defining an orifice to enable bodily waste to be received by the inner bag (12), and the flange (2) having connected to an opposite side thereof means for securing the drainage bag assembly to the body of a patient; the outer bag (6) being secured to a first attachment zone (4) on the flange and the inner bag being detachably and replaceably secured to a second attachment zone (16) on the flange, wherein the first attachment zone (4) surrounds the second attachment zone (16) and is non-overlapping therewith; and the second attachment zone (16) surrounds the means defining the orifice; and wherein the outer bag (6) can be replaceably removed or opened to permit access to the interior thereof and removal and replacement of the inner bag (12).

Description

OSTOMY BAG

This invention relates to drainage bag assemblies, such as ostomy bags, for receiving bodily waste, and more particularly to an ostomy bag containing a removable inner liner.

Background of the Invention

Ostomy bags for receiving bodily waste from colostomy and ileostomy patients are well known. One of the problems faced by users of ostomy bags, particularly colostomy bags, is how to dispose of the contents of the bag.

Many known forms of ostomy bag are made from materials that are not biodegradable and are not easily flushed down a W.C. because of, for example, the buoyancy and relative bulk of the bags. With non-flushable bags, it has been common practice to cut an edge of the bag and then deposit the contents of the bag in the W.C. for flushing away, leaving the soiled bag for separate disposal, e.g. by incineration or by wrapping and placing in a waste bin.

One solution to this problem has been to provide ostomy bags made from materials that are capable of being flushed down a W.C. and examples of such bags are disclosed in WO 94/12128, EP 0259184, US 2004/0059306, EP 0320895, US 5,989,235, GB 2083762, EP 388924, GB 2227668 and GB 2193925.

In many cases, the flushable ostomy bag comprises an inner bag which is formed from a material that disintegrates or dissolves in water or is otherwise disposable and a protective outer bag formed from a material that is resistant to water. The outer bag can be constructed so as to be reusable several times, means being provided for opening the outer bag to permit removal and replacement of the inner bag or liner. The outer and inner bags may both be attached, directly or indirectly, to an adhesive flange which comprises a layer of a bio-compatible adhesive such as a hydrocolloid adhesive to secure the ostomy bag to the body of the patient about the stomal opening. US 2004/0059306 in particular describes several forms of construction of two piece ostomy bags in which the inner bag or liner is replaceable and a re-fastenable opening is provided in the outer bag to give access to the inner bag so that it can be replaced.

US 5,785,695 (Alcare) discloses ostomy appliances comprising inner and outer bags that are releasably attached to an adhesive flange by means of mechanical couplings comprising coupling rings having annular grooves that engage corresponding annular rims on the adhesive flange to form snap-fit connections.

US 2003/0153883 (Hansen) discloses ostomy appliances comprising an adhesive flange to which is secured a first mechanical coupling ring for the attachment of an outer bag. An inner bag or liner can also be secured to the first mechanical coupling ring by means of a second mechanical coupling ring which encircles the mouth of the inner bag and which forms a snap-fit connection against the radially inner surface of the first mechanical coupling ring.

A problem with ostomy appliances employing coupling rings to connect the inner and outer bags to an adhesive flange is that the coupling rings almost invariably make the appliance stiffer and less flexible and hence less comfortable to wear. In addition, where the coupling rings for the inner and outer bags are placed relatively close together, this can make separation and replacement of the bags difficult, particularly for people with impaired or reduced manual dexterity. A further problem with ostomy appliances of this type is that the coupling ring for the inner bag must be removed from the inner bag before disposal down a WC. This adds a further and potentially awkward step to the removal and disposal process and may result in the user's hands being soiled by waste matter in the mouth or neck of the inner bag.

As an alternative to using mechanical couplings, adhesive bonding has been used to secure the inner and outer bags to the adhesive flange. Examples of ostomy bags making use of adhesive bonding can be found in US 5,865,819 (Hollister) and WO 2004/082452 (Coloplast). US 5,865,819 discloses an arrangement in which the inner and outer bags each have their own separate adhesive flange for direct connection to the body of the patient.

WO 2004/082452 discloses ostomy bags comprising an adhesive flange for attachment to the body of a patient, and inner and outer bags. The outer and inner bags are each provided with adhesive rings for attachment to the adhesive flange. In the preferred ostomy bag constructions disclosed in WO 2004/082452, the outer diameter of the adhesive ring of the inner bag is larger than the inner diameter of the adhesive ring of the outer bag and hence there is overlap between the two adhesive rings.

Summary of the Invention

The present invention provides drainage bag assemblies such as ostomy bags that give improved access to the inner bag to make removal and replacement of the inner bag easier and more convenient.

Accordingly, in a first aspect, the invention provides a drainage bag assembly for receiving bodily waste; the drainage bag assembly comprising outer and inner bags secured to one side of a flange, the flange being provided with means defining an orifice to enable bodily waste to be received by the inner bag, and the flange having connected to an opposite side thereof means for securing the drainage bag assembly to the body of a patient; the outer bag being secured to a first attachment zone on the flange and the inner bag being detachably and replaceably secured to a second attachment zone on the flange, wherein the first attachment zone surrounds the second attachment zone and is non-overlapping therewith; and the second attachment zone surrounds the means defining the orifice; and wherein the outer bag can be replaceably removed or opened to permit access to the interior thereof and removal and replacement of the inner bag.

In another aspect, the invention provides a drainage bag assembly for receiving bodily waste; the drainage bag assembly comprising outer and inner bags secured to one side of a flange, the flange being provided with means defining an orifice to enable bodily waste to be received by the inner bag, and the flange having connected to an opposite side thereof means for securing the drainage bag assembly to the body of a patient; the outer bag being secured by means of adhesive to a first attachment zone on the flange and the inner bag being detachably and replaceably secured by means of adhesive to a second attachment zone on the flange, wherein the first attachment zone surrounds the second attachment zone and is non- overlapping therewith; and the second attachment zone surrounds the means defining the orifice; and wherein the outer bag can be replaceably removed or opened to permit access to the interior thereof and removal and replacement of the inner bag.

Particular and preferred embodiments of the invention are as set out in the claims appended hereto or in the paragraphs below.

The outer bag can be replaceably removable or can have a reclosable opening to permit access to the interior thereof and removal and replacement of the inner bag. The terms "replaceably removable" and "replaceably removed" as used herein mean that the outer bag may be detached from the flange to permit access to the inner bag and then re-attached after changing the inner bag. The outer bag may be fully detached from the flange, or may be only partially removable. Where the outer bag is only partially detached, the partial detachment of the outer bag serves to form a reclosable opening giving access to the bag interior. In order to permit full or partial removal of the outer bag, the outer bag may be secured to the first attachment zone on the flange by means of a peelable adhesive or by a releasable mechanical interlocking mechanism that extends around the entire length of the first attachment zone. Alternatively, a portion of the bond between the first attachment zone and the outer bag may be constituted by a peelable adhesive or releasable mechanical interlocking mechanism, and the remainder of the bond between the first attachment zone and the outer bag may be of a more permanent nature, such as a welded (e.g. Rf welded) joint or a permanent (non-peelable) adhesive joint.

In the context of the inner bag, the term "detachably and replaceably secured" means that the nature of the means of attachment to the adhesive flange is such that the inner bag could be detached, emptied and put back on to the adhesive flange if required, or it could be replaced by a new inner bag having the same type of attachment means. In practice however, once used, a soiled inner bag will almost always be thrown away and replaced by a new inner bag.

Instead of the outer bag being folly or partially removable from the flange, the reclosable opening may be formed in other ways. For example, the outer bag may comprise front and rear panels bonded together around their respective peripheries, but wherein a portion of the seam between the front and rear panels may be opened to provide the reclosable opening. Unless the context indicates otherwise, the term "front" as used herein refers to a panel or other portion of the bag which faces outwardly, i.e. away from the patient, whereas the term "rear" as used herein refers to a panel or other portion of the bag which faces inwardly, i.e. towards the patient.

Where the outer bag is only partially removable, the opening formed by partial removal of the outer bag is typically towards the upper end of the ostomy bag and is preferably an upwardly facing opening. In order to facilitate repeated opening and closing of the outer bag, a reinforced hinge mechanism may be employed. The hinge mechanism may comprise a pair of arcuate limbs linked together at both ends by living hinges, one of the arcuate limbs being bonded to the flange and one being bonded to the outer bag. The length of the arcuate limbs can, for example, approximate to the arc of a semi-circle. The limbs are typically formed from a plastics material capable of forming a living hinge and thus withstanding repeated opening and closing without breaking. Examples of such materials include polypropylene, polyethylene and polyamides such as "Nylon".

The reclosable opening can be formed by partial opening of a seam between two panels of the outer bag, for example front and rear panels. The panels can be bonded together by Rf welding or by means of a non-peelable adhesive along a portion of the seam between the two panels and connected together by a peelable adhesive or by releasable mechanical interlocking means along another portion of the seam between the two panels. The releasable mechanical interlocking means can comprise, for example, interlocking ridges and grooves that form a releasable snap-fit connection between the panels, or a "Ziploc" type fastening extending around the seam, or releasable clamping means for holding the two panels together. In another embodiment, an opening (such as a "porthole") is formed in a panel (e.g. a front panel) of the bag, the opening being covered by a removable and replaceable cover. The cover may be releasably secured about the opening by means of a peelable adhesive or by means of a mechanical interlocking means as described above.

In the drainage bags of the invention, the attachment zones for the inner and outer bags do not overlap, and, in this respect, the bags differ from the ostomy bags disclosed in US 2004/0059306 and WO 2004/082452, where the attachment zones for the inner and outer bags are shown as overlapping.

In the bags of the present invention, the first and second attachment zones may be contiguous or they may be spaced apart.

Where the first and second attachment zones are spaced apart, they may be spaced apart by a distance greater than the width of either attachment zone. It will be appreciated from this that when one attachment zone is wider than the other, the first and second attachment zones are spaced apart by a distance that is greater than the width of the widest of the two attachment zones.

In one embodiment, the first and second attachment zones may be spaced apart by a distance greater than one and half times the width of either attachment zone, or greater than twice the width of either attachment zone.

In a preferred embodiment of the invention, the first attachment zone has opposed inner edges and the lateral distance between the opposed inner edges along a line passing through the centre of the orifice is greater than the maximum lateral dimension of the inner bag.

The arrangement of the attachment zones for the outer and inner bags provides a number of advantages and these include greater ease of access to the interior of the outer bag for replacement of the inner bag and greater ease of manufacture. Moreover, because the attachment zones for the outer and inner bags do not overlap, it is possible to impart different properties to the two zones. For example, the degree of adhesion of each bag to its respective attachment zone can be controlled by using different types or grades of adhesive for each zone.

The outer bag is typically formed from a waterproof material which acts as a barrier to flatus gases. Examples of such materials include polyvinyl chloride (PVC), polyvinyl dichloride (PVDC)₅ ethylene vinyl alcohol and related materials and combinations thereof.

In order to prevent the undesirable build up of flatus gases within the bag, the wall of the outer bag can be provided with a flatus filter which permits gases to exit the bag but filters out malodorous and noxious gases. Such filters are well known and need not be described here.

The inner bag is preferably detachably and replaceably secured by means of adhesive to the second attachment zone on the flange. The adhesive is a peelable adhesive and may, for example, be a pressure sensitive adhesive that allows the inner bag to be attached to the second attachment zone by the application of finger pressure by the patient or carer. The peelable adhesive can be located on the second attachment zone, or on a ring surrounding the mouth of the inner bag, or on both. In one embodiment, the inner bag is provided with a ring of peelable adhesive surrounding the mouth of the bag.

The inner bag may be formed from a non-disposable waterproof material of a type described above for the outer bag, but preferably the inner bag is formed from a material that is biodegradable or disposable, such as polyvinyl alcohol. For example, the inner bag can be formed from a polymer, such as polyvinyl alcohol, of a type or grade that is slowly soluble in cold water but is more soluble in hot water. Examples of types of polyvinyl alcohol suitable for use in the fabrication of inner bags or liners are described in our earlier application WO94/12128.

Brief Description of the Drawings

Figure 1 is an exploded schematic view showing a flange, inner bag and outer bag of an ostomy bag according to one embodiment of the invention. Figure 2 illustrates a liner or inner bag for an ostomy bag.

Figure 3 illustrates an ostomy bag in which the outer bag has been opened to reveal the inner bag.

Figure 4 illustrates a hinge mechanism for a reclosable opening in an outer bag.

Figure 5 illustrates an outer bag with a reclosable opening along its edge seam.

Figure 6 illustrates an outer bag with a porthole to provide access to the inner bag.

Figures 7a and 7b illustrate a reclosable opening in an outer bag of an ostomy bag according to another embodiment of the invention.

Detailed Description of the Invention The invention will now be described in more detail, but not limited, by reference to the specific embodiments illustrated in the drawings.

Referring now to the Figures, Figure 1 is an exploded schematic view showing the component parts of an ostomy bag according to one embodiment of the invention. The ostomy bag comprises an adhesive flange 2 comprising a backing layer of a polyethylene material to one side of which is attached a layer of hydrocolloid adhesive. The hydrocolloid adhesive, which may be of conventional type, serves to secure the ostomy bag to the body of a patient. A silicone release layer (not shown) covers the hydrocolloid adhesive layer and protects the adhesive layer against damage and/or drying out prior to use of the bag.

On the side of the flange opposite to the hydrocolloid adhesive is a first attachment zone designated in Figure 1 by the numeral 4. An outer bag 6 having an opening 8 surrounded by a ring 10 of peelable adhesive is secured to the flange 2, the ring of peelable adhesive 10 bonding to the flange at the first attachment zone 4.

Disposed within the outer bag, is a removable inner bag or liner 12. The inner bag or liner 12 is provided with a ring of peelable adhesive 14, which bonds to the flange 2 at the second attachment zone 16. The ring of peelable adhesive 14 is provided with a tab 18 to facilitate removal of the inner bag from the flange. The first attachment zone 4 and the second attachment zone 16 are spaced apart radially and the spacing between the two attachment zones is greater than the width of either of the two attachment zones. In the embodiment shown, the lateral distance D along a line running through the centre of the orifice 20 between opposed inner edges 4a and 4b of the first attachment zone is greater than the maximum lateral dimension of the inner bag 12.

An advantage of this arrangement is that it enables the inner bag 12 to be separated from the outer bag 6 more easily. A further advantage arising from the wider spacing between the concentric attachment zones is that a single release paper can be used for the adhesive rings 10 and 14 of both the inner and outer bags which are thereby held together and can be supplied to the user as a single unit. This reduces the number of parts and hence the relative cost of the ostomy appliance.

A still further advantage of the arrangement of the spaced concentric attachment zones is that it provides improved access to the inner bag. This can be of considerable benefit where the inner bag has become inflated with excess flatus gas since the user is easily able to partially separate the inner bag from the adhesive flange to allow escape of the flatus gas, and then reseal the inner bag against the adhesive flange.

The outer bag 6 in this embodiment can be formed from materials well known for the construction of ostomy bags. Thus, for example, it can be formed from a tough, flexible, transparent, waterproof material such as polyvinyl chloride (PVC), polyvinyl dichloride (PVDC), ethylene vinyl alcohol, related materials and combinations thereof in known fashion. The outer bag may be formed from a pair of sheets of the flexible waterproof material, one sheet being cut so as to form the opening 8 and the other sheet having the same outer periphery, but no opening. The two sheets can be secured together around their respective peripheries by welding, (for example Rf welding) or by means of adhesive.

In use, faecal material from a stomal opening passes through the opening 20 in the flange and into the interior of the inner bag or liner 12. When the inner bag or liner 12 is full, the outer bag 6 may be peeled away from the flange, giving access to the inner bag, which may also be peeled away and then disposed of. A new liner or inner bag 12 may then be attached to the flange, and the outer bag 6 re-attached to the flange.

An advantage of the arrangement shown in Figure 1 is that it reduces the frequency with which the adhesive flange is removed from the body and a fresh adhesive flange applied. This not only reduces material wastage, but also minimises discomfort to the patient.

The outer bag can be fully removable from the flange, or only partially removable. For example, the bond between the ring 10 and the first attachment zone 4 may be formed partially by means of a peelable adhesive, and partially by means of a more permanent adhesive, or by welding. Alternatively, instead of a peelable adhesive, a physical interlocking system may be used. The physical interlocking system can be, for example, provided by means of a rib on one component engaging a channel on the other component in a snap-fit joint. Alternative physical interlocking systems include hook and loop systems of the "Velcro^®" or Cric Crac^® type, or interlocking "mushroom" fasteners of the type manufactured by Gottlieb Binder GmbH of Holzgerlingen, Germany. Particular fasteners of interest include fasteners that provide a substantially water-tight closure.

An inner bag or liner is illustrated in more detail in Figure 2 and comprises a pair of sheets, 30 and 32 (not shown) secured together by means of a weld 34 around their peripheries. The inner bag or liner 30 has an opening 36 surrounded by a ring of a peelable adhesive 38, covered by a silicone release layer (not shown). A tab 40 assists in removal of the liner from the flange. The inner bag 30 may be formed from a non-disposable waterproof material such as polyvinyl chloride or polyvinyl dichloride or a PVC/EVA or PVDC/EVA laminate, or another material similar to the materials from which the outer bag is made. Alternatively, the inner bag can be formed from materials that are biodegradable or disposable. Examples of materials suitable for forming a disposable liner are described in our earlier patent application WO94/12128 and include polyvinyl alcohol of an appropriate solubility grade. Figure 3 illustrates a two piece ostomy bag in which the outer bag 6 can only be partially separated, to an extent sufficient to allow removal of the liner 12 and its replacement.

In order to provide a firmer engagement and disengagement action when the outer bag is opened or partially removed from the flange, a hinge mechanism may be employed and one such mechanism is shown in Figure 4. The hinge mechanism illustrated in Figure 4 comprises a pair of generally semi-circular limbs 50 and 52, linked together by living hinges 54 and 56. Tabs 58 and 60 are provided to assist the user to pull the two limbs apart. The limb 52 of the hinge mechanism is secured to the first attachment zone of the flange, for example by Rf welding, whilst the second limb 50 of the hinge is secured (again by Rf welding or adhesive) to the outer ostomy bag. The confronting surfaces of the two limbs may be provided with a peelable adhesive to allow them to be releasable secured together, or they may be provided with a mechanical fastening mechanism, for example of the type described above.

In the embodiment shown in Figure 5, the outer bag comprises front 64 and rear panels 66, the rear (i.e. body-side) surface of rear panel 66 being bonded by non- peelable adhesive or by Rf welding around its entire periphery to the adhesive flange 68. The front panel 64 is permanently bonded to the rear panel along part of its periphery but is releasably attached to the rear panel along the remainder of its periphery by means of the line of peelable adhesive 70. Thus, in this embodiment, the seam between the front and drear panels opens up to give access to the interior of the bag for removal of the inner bag or liner 72.

In a further form of construction, a panel or wall of the outer bag may be provided with an opening to allow access to the replaceable inner bag or liner. Figure 6 illustrates an embodiment in which a "porthole" is created in the outer bag wall, and a cover 60 is secured in place by a ring of adhesive around its periphery. A tab 62 is provided to assist in removal of the porthole cover.

In a further alternative, as shown in Figures 7a and 7b, an opening 80 may be formed in the outer bag along a seam, the opening being closed by a temporary closure mechanism 82, such as a clip and folding mechanism using, for example, "Velcro ^®" or an equivalent fastening means such as Cric Crac^®, or interlocking "mushroom" fasteners of the type described above, or a closure of the "Ziploc^®" type.

Equivalents

It will readily be apparent that numerous modifications and alterations may be made to the specific embodiments of the invention described above without departing from the principles underlying the invention. All such modifications and alterations are intended to be embraced by this application.

Claims

1. A drainage bag assembly for receiving bodily waste; the drainage bag assembly comprising outer and inner bags secured to one side of a flange, the flange being provided with means defining an orifice to enable bodily waste to be received by the inner bag, and the flange having connected to an opposite side thereof means for securing the drainage bag assembly to the body of a patient; the outer bag being secured by means of adhesive to a first attachment zone on the flange and the inner bag being detachably and replaceably secured by means of adhesive to a second attachment zone on the flange, wherein the first attachment zone surrounds the second attachment zone and is non-overlapping therewith; and the second attachment zone surrounds the means defining the orifice; and wherein the outer bag can be replaceably removed or opened to permit access to the interior thereof and removal and replacement of the inner bag.

2. A drainage bag assembly for receiving bodily waste; the drainage bag assembly comprising outer and inner bags secured to one side of a flange, the flange being provided with means defining an orifice to enable bodily waste to be received by the inner bag, and the flange having connected to an opposite side thereof means for securing the drainage bag assembly to the body of a patient; the outer bag being secured to a first attachment zone on the flange and the inner bag being detachably and replaceably secured to a second attachment zone on the flange, wherein the first attachment zone surrounds the second attachment zone and is non-overlapping therewith; and the second attachment zone surrounds the means defining the orifice; and wherein the outer bag can be replaceably removed or opened to permit access to the interior thereof and removal and replacement of the inner bag.

3. A drainage bag assembly according to claim 1 or claim 2 wherein the first and second attachment zones are contiguous.

4. A drainage bag assembly according to claim 1 or claim 2 wherein the first and second attachment zones are spaced apart.

5. A drainage bag according to claim 4 where the first and second attachment zones are spaced apart by a distance greater than the width of either attachment zone.

6. A drainage bag according to claim 5 wherein the first and second attachment zones are spaced apart by a distance greater than one and half times the width of either attachment zone (for example greater than twice the width of either attachment zone)..

7. A drainage bag according to any one of claims 1 to 6 wherein the first attachment zone has opposed inner edges, the lateral distance between the opposed inner edges along a line passing through the centre of the orifice being greater than the maximum lateral dimension of the inner bag.

8. A drainage bag according to any one of the preceding claims wherein the means for securing the drainage bag assembly to the body of a patient comprises a layer of adhesive such as a hydrocolloid adhesive.

9. A drainage bag according to any one of the preceding claims wherein the outer bag is fully removable from the flange to allow replacement of the inner bag.

10. A drainage bag according to claim 9 wherein the outer bag is releasably bonded to the first attachment zone by means of a peelable adhesive.

11. A drainage bag according to any one of claims 1 to 8 wherein the outer bag is partially removable to allow replacement of the inner bag.

12. A drainage bag according to claim 11 wherein a portion of the outer bag is bonded to the first attachment zone by means of a peelable adhesive.

13. A drainage bag according to any one of the preceding claims wherein a living hinge mechanism is disposed between a portion of the outer bag and the flange, the living hinge mechanism providing a reclosable opening for the outer bag and comprising a pair of hinge limbs linked together at the two ends of each hinge limb by living hinges so as to define a reclosable opening, one of the hinge limbs being attached to a front panel of the outer bag and the other hinge limb being attached to the flange or a rear panel of the outer bag, the two hinge limbs being provided with releasable securing means on confronting surfaces thereof for holding the limbs together to close the opening.

14. A drainage bag according to claim 13 wherein the hinge limbs are arcuate.

15. A drainage bag according to claim 11 wherein the outer bag is formed from front and rear panels secured together around their respective peripheries, a portion of a seam between the pair of panels at the peripheries thereof being openable to permit access to and replacement of the inner bag.

16. A drainage bag according to claim 15 wherein a living hinge mechanism as defined in claim 13 or claim 14 is disposed between the panels in the openable portion of the seam.

17. A drainage bag according to any one of the preceding claims wherein an opening is formed in a panel (e.g. a front panel) of the outer bag, the opening being closed by a removable and replaceable cover.

18. A drainage bag according to claim 17 wherein the cover is releasably secured about the opening by means of a peelable adhesive or a mechanical interlocking means.

19. A drainage bag according to any one of the preceding claims wherein the inner bag is formed from a biodegradable material or a material that disintegrates upon flushing down a W.C.

20. A drainage bag according to any one of the preceding claims which is an ostomy bag.

21. A drainage bag substantially as described herein with reference to the accompanying drawings.