GB2528305A - Flushable two piece ostomy bag - Google Patents

Abstract

An ostomy bag has a flange 4 separably attached to at least one pouch. The pouch has an inlet leading to a waste collection space defined by two opposing surfaces of two walls. The flange 4 has a plurality of pouch-facing, removable layers 21 enabling it to be reused with a plurality of separate pouches. A fresh adhesive surface is revealed by removing a layer each time a bag is removed for emptying. The ostomy pouch may have an inner and outer bag. The inner bag may be flushable. The flange layers may have a laminated structure. The body facing layer may be hydrocolloid adhesive 30 with manuka honey, covered with a release liner 31. The other side may have a backing layer 19 on which the removable layers 21 are placed. The removable layers 21 may have tabs 32.

Description

Intellectual Property Office Application No. GB1412727.8 RTM Date:28 January 2015 The following terms are registered trade marks and should be read as such wherever they occur in this document: Exopack (registered) Intellectual Property Office is an operating name of the Patent Office www.ipo.govuk

FLUSHABLE TWO PIECE OSTOMY BAG

The present invention relates to an ostomy bag for coilection of waste from a human or animal body. In particular the invention provides a flushable two piece ostomy bag.

8ackgmund of the Invent/on Ostomy bags are medical devices that are worn by an indMdual and they can be used for the collection of waste from a surgically diverted bowel or urinary system of the indMdual. They are used to coUect waste that is output from a stoma created in the ostomate's skin and connected to the intestine or urinary system.

Known ostomy bags compnse a collection pouch and in some cases the coflection pouch is attached mechanically or with adhesive to a flange, common'v referred to as a mountng plate, wafer or a baseplate The flange is fixed to tie skin of an individual and the ostomy bag aVows waste to drain from a stoma into the codection pouch, while protectinq the surrounding skin from contarninatioi by tne waste Cstomy bags should be a.r and water-tight and they should allow the individual to lead ar active norma lifestyle that can incude al forms of sports and recreation In addition, there is a need to make ostomy bags discrete, The need to provide discrete ostomy bags must be balanced with the needs (1) to provide a secure connection and (2) to provide a sufficiently large collection bag so that unexpected deposits can be accommodated by the bag. For example, if an individual suffers from an upset bowel, the bag should not overflow. Typically, ostomy bags are emptied at least once per day.

Ostomy bags can be secured to an individual by means of a belt or strap, but more usually they are affixed to the patient by means of an adhesive flange which surrounds the stomal orifice. Typically the flange has a layer of a dermatologically compatible hydrocolloid adhesive. Although the hydrocollold adhesives are relatively benign, repeated application and removal of fresh adhesive flanges can cause irritation and discomfort to the patient and, for this reason, in situations where an ostomy bag needs to be changed frequently, a two-piece ostomy bag is often used.

A two-piece ostomy bag typcally has a two-part connector, one part of which has an adhesive flange attached thereto, and the other part of which is attached to a pouch.

One advantage to such an arrangement is that the adhesive flange may be left in position on the patient's skin whilst the pouch can be replaced as required.

However, a disadvantage with existing two-part connectors is that they are frequently formed from a relativeiy rigid material, and have a high profile which means that they can be seen easily through a user's clothing.

In addition, they can be uncomfortable, as weD as being relatively cumbersome to use.

In this regard, some known devices use a lockng ring arrangenent which requires accurate positioning and good manual dexterity This can pose problems for cieople who have impaired manual dexterity.

Furthermore, a major problem is that it is difficult to dispose of a used ostorny bag in a convenient and hygienic nanrer For example, sore existing bags require a user to cut an edge of the bag to deposit the bag's content down a toilet, whilst the soiled bag is disposed of separately. The soiled bag needs to be wrapped and placed in a bin or incinerated The disposal of a bag in this way is unhygienic, unpleasant and inconvenient for a user.

Various proposals have been made for oston'y bags which can be flushed down a toilet However, there are significant disadvantages with the products that have been developed to cate The buoyancy, lack of degradabiht»= and bulk of used bags mdkes it difficult to flush them away. In particular, one part of the two-part connector discussed above remains attached to the pouch of known two-piece bags. Its rigidity and bulk, required cor function as part of a connector, means that it is oifflcult to flush away and does not decompose or degrade readily. If they do not decompose or degrade readily th' cause a pollution problem in the sewerage system and environmental damage foliowing disposal.

The ostomy bags disclosed in EP0703762 and EP0768848 sought to overcome some of the problems descrioed above by providiry a removable inner bag provided wthin ar outer bag. In use, the inner bag is sumciently water-impermeable to prevent leakage but, when disposed of, would gradually dissolve to be flushed down a toilet after use.

The inner flushable bag is secured to the durable outer protective bag by a peelable coinection After use, when the inner bag is to be disposed of, the peelable conrection is torn away and the inner bag has to be removed from the outer bag to be ñushed down the toilet, The outer bag would not be soiled by the bodily waste but has to be disposed of separately, for example, with other household refuse, The removal of the nner bag still remains an inconvenience for a user and may be impractical for patients unable to carry out such tasks Also the outer bag, which is not biodegradable, ados to landfill.

A peelable and flushable ostomy appliance is also disclosed in EPO4795863 To allow disposal of the bag, a peelable sealing seam is broken such that the outer pouch walls are peeled away from an inner pouch. The inner pouch and fts contents can be deposited in the bowl of a toilet and flushed away. However, the outer pouch walls need to be folded together and disposed of in some other manner, for instance in a pocket or a refuse container. The removal of the inner bag again is an inconvenience for a user and may be impractical for patients unable to carry out such tasks, such as the eiderly or disabled. The outer bag, which is not biodegradable, adds to landfilL In view of the above, there is a need for alternative ostomy bags which address one or more of the problems presented by prior art arrangements. In particular, the present nventioi seeks to provide a two-piece ostomy bag which Is dscrete and whith has an inner pouch which can be flushed away in a toilet and which has a flange that is protected from contamination so that it can be used with a plurality of inner and outer pouches.

Sumrnatv of the Invention Remarkably, it has now been found that an ostomy bag can be provided that is in the form of a two p ece ostomy bag naving an nner pouch that can be flushed away The invention provides the advantage that an ostomy bag can be provided that has a more discrete aopearance than known ostomy bags, but it is capable of containing the same volume as known ostomy bags. In addition, the invention provides an ostomy bag having a flange that is protected from contamination so that it can be used with a plurafity of inner and outer pouches.

In accordance with the present invention, there is provided an ostomy bag having a flange adjoining separably at least one poach wherein the pouch has an inlet leading to a waste collection space defined by two opposing surfaces of two walk, the opoosing surfaces configured to separate on the introduction of waste through the inlet and wherein the flange has a plurality of pouch facing removable layers enabling it to be reused with a plurality of separate pouches.

Preferably, a single flange is used with a plurality of separate pouches successively.

Preferably, the removable layers have adhesive appiled thereto and can be rem. oved separately to expose a fresh surface allowing for clean apphcatioi of a new pouch when renewal is required. Preferably, the removabie layers are release liner layers. In addition, the bulk associated with prior art connectors used in known two-piece ostomy bags is avoided, thereby providing a flushable product.

Preferably, the pouch comprises a foam gasket around the inlet.

Preferably, the ostoniy bag comprises an inner pouch and a separate outer pouch.

Advantageously, the inner pouch Is provided for stornal waste collection and the outer pouch is providec for protection of the in ier pouch Preferably, in use the inner pouch is located loose in the outer pouch.

Preferably, adhesive is applied to the gasket for seaUng to a pouch facing removable k3yer of the flange Preferably the adhesive apphed to the gasket is protected by a release liner until it is ready for use.

Preferably, the inner pouch comprises an inner pouch ring around the inlet The inner pouch is placed inside the outer oouch and the inner ouch ring is located concentncally inside the gasket of the outer pouch.

Preferably, adhesive applied to the gasket of the outer pouch has weaker achesion compared to adhesive applied to the inner pouch ring. This provides the advantage of FaC litating removal of the outer pouch prior to removal of the inner pouch Preferably, the adhesive applied to the gasket of the outer poucn has sufficient strength to hold the pouch in position for up to 12 hours, but it is easily removable for pouch detachment, and this provides the advantage that detachment causes as little damage to the pouch components as possible.

Preferably, the flange has a laminated structure having a plurality of layers.

Preferably the flange comprises a body facing layer. Preferably, the body facing layer comprises hydrocolloid. More preferably, it comprises hydrocolloid and manuka honey.

Preferably, the body facing layer s PL backed Preferably, the body facing layer is covered by a release liner prior to use The release liner can be peeled away to expose the body faciri layer To facilitate peeling the release liner from the body facing layer, the release liner preferably has a tab. The tab can be gripped and pulled to peel the release liner from the body facing layer Preferably, the release liner is of PET.

Preferably, the fiance comrlses a backing layer Preferably, the backing layer is aojacent to the body facing layer Preferably, the backing layer is welded or stuck with adhesive or hot melt adhesive to the body facing layer, Preferably, the backing layer is of PVC.

Preferably, the flange comprises a plurality of removable layers applied to the backing laye Preferably, each removable release liner layer is of PET Preferably, each removable release liner layer is coated with adhesive. Preferably! the adhesive is applied to both sides of the removable release liner layer. Preferably, the adhesive is silicone based.

Preferabiy, each removable layer has a tab. The tab can be gripped and pulled to peel the removable layer from an adjacent layer.

Preferably, there are at least two removable layers. More preferably, there are at least three removable layers.

In a preferred embodiment, there are four or five removable layers.

The laminated structure provides the advantage that the height of the coupling between the pouch and the distance the flange extends prom a users body is minimised compared to known two piece ostomy bags having mechanical coupl ngs which in turn means that visiblity through a users clothing s minimised

Br/sf Description of the Drawings

The invention will now be described in detail by reference to the accompanying drawings, in which, Figure 1 shows front and back views an ostomy bag according to the invention; Figure 2 shows an exploded view of the constructon of an ostomy bag according to the invention Figure 3 shows a view of the flange of the ostomy bag of Figures 1 and 2; FIgure 4 shows an exploded view of the construction of a flange of Figure 3; FIgure 5 shows an exploded view of the disassembly of the flange shown in FIgure 3; Figure 6 shows a view of the aflgnment of an inner pouch and outer pouch of an ostomy bag shown in Figures 1 and 2; and Figure 7 shows a view of an ostomy bag having assembied flange, together with inner and outer pouches Detailed Descnot/on of the invent/on ft will be appreciated that aspects, embodiments and preferred features of the invention have been described herein in a way that aHows the specification to be wriften in a clear and concise ways However, unless circumstances dearly dictate otherwise, aspects, embodments and preferred features can be variously combned or separated in accordance with the invention. In a preferred embodiment1 a device in accordance with the invention comprises all aspects of the invenuon.

Within the context of this specification, the word "about" means preferably plus or minus 20%, more preferably plus or minus 10%, even more preferably plus or minus 5%, most preferably plus or minus 2%.

Within the context of this specification, the word "comprises" means "includes, among other things" and should not be construed to mean "consists of only".

Within the context of this specification, the word "substantially" means preferably at least 90%, more preferably 95%, even more preferably 98%, most preferably 99%.

According to the invention, the bag can be a dosed bag, or a drainable bag having an opening through which the bag may be drained Referring to the drawings, figure 1 shows front and back views of an ostomy bag [1] according to one embodiment of the invention which comprises a flange [4], ar outer protective pouch [2] and an inner waste-collecting pouch [3].

Preferably, the bag comprises a flange [4] which abuts the inlet. In this regard, the flange [4] defines an aperture [5, 13, 22]. In use, the flange [4] is appfled to the skin around a stoma and provides a surface to which a pouch [2,31 can be applied.

Preferably, the bag comprises a disposable or degradable inner pouch enclosed in a hydrophobic outer pouch and means for conveniently removing the inner pouch for disposal.

Preferably, the outer protecuve pouch [2] comprIses a laminate material with an outer layer of water-impermeable material and an inner layer of water-soluble material.

Preferably, the inner waste-collecting pouch [3] enclosed within the outer protective pouch [2] compnses a laminate material with an outer layer of water-soluble materia' and an inner layer of water-impermeable material.

Preferably, the walls of the inner and outer pouches [2] and [3] are welded together at their edges.

Preferably, the inner aid outer protective pouches [2] and [3] are removably sealed to the flange [4] and both the outer protective pouch and the inner waste-collecting pouch are of a structure which is weakened upon immersion in a toilet bowl to become less buoyant such that the pouches can be flushed away.

It is to be understood that reference to the inner layer refers to the layer closest to the waste collected and the outer layer refers to the layer furthest from the waste collected.

Preferably, the or each layer of the inner waste-coflecting pouch [3] is odour impermeable.

Preferably, the water-soluble material comprises polyvinyl acetate/ polyvinyl alcohol.

Preferably, the water-soluble material is formed from biodegradable fibres.

Optionally, the water-solub!e material is hydrophobic.

An outermost layer of nydrophobic material provides the advartage of allowirg a user to bathe or shower without the bag absorbing water and becoming uncomfortable to wear.

A hydrophobic outer layer aUows the bag to be dried and enhances the comfort of the bag when worn by a user.

Preferably, the water-mpermeabie material comprises ethylene vinyl alcohol, or silicon or PTFE eg Teflon (RTM), or a starch-based fOm, or a film having a surface that is hydrophobic.

1; Preferably, the water-impermeable material Is plasma treated or coated with a hydrophobic layer ft is envisaged that, by plasma treatment or coating, the water-impermeable material is adapted to be hydrophobic Optionally, the outer protective pouch 2] further comprises an outermost layer of fibrous material.

An outermost layer of fibrous material is used as a comfort layer to make the bag more attractive to a user and more comfortable to wear next to the skin.

Preferably, a waD of the outer protective pouch [2] is provided with a flaWs filter, optionally comprising activated charcoal. A flaWs fliter permits gas to be exhausted from the bag, whilst filtering out malodorous gases. Preferably) the activated charcoal is supported by a degradable polymer, such as polylactic acid.

More preferably, the filter is laminated on its major surfaces with a biodegradable fVm, such as poyvinyl acetate.

Preferably, the laminate materIal of the outer protective pouch [2] has a thickness of between about 0.025 and 0,100mm, wherein the outer layer of water-impermeable material has a thickness of between about 0,005 and 0.020mm and the inner layer of water-soluble material has a thickness of between about 0.020 and 0.080mm, Preferably, the laminate rnateral of the inner waste-collecting pouch [3j has a thickness of between about 0 025 and 0 100mm, wherein the outer layer of water-soluble material has a thickness of between about 0.005 and 0.020mm and the inner layer of watei -impermeable natenal has a th ckness of between about 0 023 and 0 080mm The inner pouch [3j is made of a laminate material. The innermost layer [6] of the inner pouch [3] is a thin EVA (ethylene vinyl alcohol) film, such as DEV-07-04A from Exopack.

The innermost layer [6] is waterproof and strong enough to contain bodily waste held therein and provides an odour barrier. The innermost EVA layer [6j is only a small proportion of the total thickness of the inner pouch [3L such that it is relatively insignificant to the bulk of the inner pouch [3]. This allows the inner pouch [31 to be flushed away.

The outer pouch [2] is formed from front [7] and rear (8] sheets of a touch waterproof multiiaminar film material comprising a layer of polyAnylidene dichloride and optionally one or more further barrier layers sandwiched between two ayers of ethylenevinylacetate (EVA) Such film can be obtained from W R Grace Gmbh of Larderstedt, Germany Sheets [7] and [8] are sealed together around their peripheral margins [9] and [101 by welding, for example RF welding. Optionally, a third layer [11]

-H -

which is a comfort layer formed from a non-woven material is secured to sheet [7, 8], again by means of welding around its peripheral margins [12].

Sheets [9] and [11] define generally drcular openings [13] and [14] respectively providing an inlet through which bodily waste from the stomal orifice of a user can pass Welded to sheet [8] and surrounding the opening [13] is an annular gasket [15] formed from a flexible grade of foam. For example, the foam can be of EVA. The annular gasket [151 has a generally semi-circular tab [16], the purpose of which will be appaitnt

from the description below.

Affixed to the annular gasket [15] by means of heat seahng is a refastenable adhesrve tape [17] The outwardly facing adhesive layer is normally covered with an annular release paper [18]. The refastenable adhesive tape [17] forms one half of a refastenable tape arrangement of the tyoe available from the Minnesota Mining ano Manufacturing Company.

Referring now to Figures 4 and 5, the flange [4] is provided with a backing layer [19] coated with hydrocolloid adhesive layer [30] which serves to adhere the flange [4] to the skin of a patient about the stomal orifice. The flange [4] has a generally semi-circular tab [20] to assist in removal of the flange [4] after use. Secured to the flange [4] is removable layer of an annular release layer [21] to which the refastenable adhesive tape [17] on the ostomy bag can be releasably attached.

A release paper [31] covers the hydrocolloid adhesive layer [30] prior to use. Attached to the front surface (also referred to as the pouch facing surface) of the flange [4] are multiple removable layers [21] also referred to as release layers or release Iriets [21] in use, the user removes the release paper [31] from the rear or body facing surface of the flange [4], the central opening [22] being cut to the appropriate size to accommodate the protruding end of a stoma The flange [4] is then adhesivey fixed in place to the skin about the stomal opening. -12-

The inner and outer pouches [3] and [2] of the ostomy bag [1] are adhered to the flange [4] by firstly placing the nner pouch [3] insIde the outer pouch [2.], aligning the inner pouch ring [23] concentrically inside the annular gasket [15] of the outer pouch [2], and secondly bringing the flange 4] and the inner pouch ring [23] on the inner pouch [31 as well as the annular gasket [15] on the outer pouch [2] together so that substantially watefrtight seals between the flange [4] and the inner pouch ring [23] as well as between the flange [4] and the gasket [15] of the outer pouch [2] are formed To fadfltate alignment of the inner pouch dng [23] of the inner pouch [3] concentrically inside the gasket [15] of the outer pouch [2], one or more alignment tabs [24] are provided.

The adhesive tape [25] on the annular gasket [15] as well as adhesive on the inner pouch ring [23] engages the removable layer [21] on the flange [4 to form an adhesive union between the flange [4] and the gasket [15] as well as the inner pouch ring [23].

In so doing, the inner and outer pouches [3] and [2] are coupled to the flange [4].

In time, the inner pouch [3] fills up with stomal waste products and will require changing. Rather than remove the entire assembly, the outer pouch [2] is removed from the flange [4] by separating the flange [4] and annular gasket [15]. The semi-circular tabs [16] can be grasped to assIst in the pulling apart of the flange [4] and the annular gasket [15] The outer pouch [2] can then be dscarded or reused This leaves the inner pouch [3j still adhered to the flange [4].

The inner pouch [3] is removed from the flange [41 by separating the fldnge [4] and the inner pouch ring [23]. The semi-circular tabs [27] can be grasped to assist in the pulling apart of the flange [4] and the inner pouch ring [23], The inner pouch [3I can then be discarded by removing the release liner [29] from the inner pouch ring [23] and by flushing it away After removing a removable layer [21] from the flange [4] to expose a clean uncontaminated surface, fresh inner and outer pouches [3] and [2] can be coupled to the flange [4]. In this regard, a fresh inner pouch [3] can be placed inside a fresh outer pouch [2], release liners [29] and [18] can be removed from the inner pouch ring [23] and the gasket [15], and the inner and outer pouches [3] and [2] can be applied together to the flange [4].

The advantage of the arrangement illustrated in the drawings is that it is not necessary to tear the flange [4] away from the patient's skin each time it is necessary to change the ostomy bag [1]. In addition, a dean surface is provided for attachment of each ostomy pouch. Therefore, much of the irritation and discomfort assodated with the fitting and removal of the ostomy bag [1] can be avoided.

The ostomy bag arrangement shown in the drawings is particularly advantageous in that it is entirely formed from flexible materials and is therefore more comfortable to the patient than exsting couphng arrangements formed from more rigid materials In addition, in many existing two-part coupling arrangements, a mechanical snap-fit fastening arrangement is employed which comprises an upstanding rim on one half o the connector over which a locking ring is snapped. The result is a rather bulky union which is often visible through the patient's clothing. According to the present invention, the total height of the abutment of the flange and pouch when fitted together is no more than about 3mm and can be as lithe as about 2mm. This contrasts with known airangements in which the two coupling halves are superimposed or concentrically arranged and as a result have coupling arrangements of 6mm or more in depth.

The above described embodiments have been given by way of example only, and the skillec reader will iaturally appreciate that many variations could be made thereto without departing from the scope of the invention. -14-

Claims (22)

1. CLAIMS1. An ostomy hag having a flange adjoining separably at least one pouch wherein the pouch has an inlet leading to a waste collection space defined by two opposing surfaces of two walls, the opposing surfaces configured to separate on the introduction of waste through the inlet and wherein the flange has a plurafity of pouch facing removable layers ena'iling it to be reused with a plurality of separate pouches.
2. 2. An ostomy bag according to claim 1 wherein the pouch comprises a foam gasket around the inlet.
3. 3 An ostomy bag accoróng to clan 1 or 2 wneren adhesive is applied to the gasket for sealing it to a removable layer of the flange.
4. 4. An ostomy bag according to any preceding cia m wherein the ostomy bag comprises an inner pouch and a separate outer pouch.
5. 5. An ostomy bag according to claim 4 wherein the inner pouch comprises an inner pouch ring around the inlet.
6. 6 An ostomy bag according to claim 5 wherein the inner pouch is placed inside the outer pouch and the inner pouch ring is located concentrically inside the gasket of the outer pouch.
7. 7 An ostomy bag according to cairn 6 wherein adhesive is appied to the gasket of the outer pouch and the adhesive has weaker adhesion compared to adhesive applied to the inner pouch rIng.
8. 8.4 An ostorny bag according to claim 7 wherein the adhesive appUed to the gasket of the outer pouch has sufficient strength to hold the pouch in position for up to 12 hours, but it is easily removable for pouch detachment.
9. 9. An ostomy bag according to any proceedIng claim wherein the flange has a laminated structure having a plurality of layers. -15
10. 10. An ostomy bag according to claim 9 wherein the flange comprises a body facing layer.
11. 11 An ostomy bag accorcnng to claim 10 wherein the body fdcing layer comprises hydrocolloid.
12. 12. An ostomy bag according to claim 11 wherein the body facing layer comprises hydrocoUoid and nianuka honey.
13. 13 An ostomy oag according to dny one of claims 10 to 12 wherein the body facing layer is covered by a release ilner prior to use and wherein the release liner can be peeled way to expose the body facing layer.
14. 14. An ostomy bag according to claim 13 wherein the release liner has a tab for easy removal.
15. 15. An ostomy bag according to any one of claims 9 to 14 wherein the flange comprises a backing layer adjacent to the body facing layer.
16. 164 An ostomy bag according to any one of claims 9 to 15 wherein the flange comprises a plurality of removable ayers applied to a backing layer.
17. 17. An ostomy bag according to claim 16 wherein each removable layer is coated with adhesive.
18. 18 An ostomy bag according to claim 17 wherein the adhesive is applied to both sides of the removable layer.
19. 19 An ostomy bag according to any one of claims 16 to 18 wherein each removable layer has a tab for easy removal.
20. An ostomy bag according to any one of claims 16 to 19 wherein there are at least two removable layers.
21. 21. An ostomy bag according to any one of daims 16 to 20 wherein there are at east three removable ayers
22. 22. An ostomy bag substantially as described herein wth reference to the accompanying Figures.