WO2018033413A1

WO2018033413A1 - Flange extender having removal tab

Info

Publication number: WO2018033413A1
Application number: PCT/EP2017/069850
Authority: WO
Inventors: Arash MOAVENIAN
Original assignee: Welland Medical Limited
Priority date: 2016-08-18
Filing date: 2017-08-04
Publication date: 2018-02-22
Also published as: GB201614115D0; GB2553096B; GB2553096A

Abstract

A flange extender (4) for extending the flange of an ostomy bag, thereby increasing security of the connection between a user and the ostomy bag, has at least one removal tab (9) which facilitates removal of the flange extender from a user after use. The flange extender is especially suitable for medical purposes, in particular the flange extender can be used to maintain and promote healthy skin, in particular in the peri-stomal area.

Description

Flange Extender Having Removal Tab

The present invention relates to a flange extender having a removal tab, wherein the flange extender can be used to extend the flange of an ostomy bag, thereby increasing security of the connection between a user and the ostomy bag; and the removal tab facilitates removal of the flange extender from a user after use. The flange extender according to the present invention is especially suitable for medical purposes, in particular the flange extender can be used to maintain and promote healthy skin, in particular in the peri-stomal area.

Background of the Invention

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

Known ostomy bags comprise a pouch or collection bag manufactured of film and in some cases the pouch is attached mechanically or with adhesive to a flange which forms a mounting plate, commonly referred to as a wafer or a baseplate. In use, the flange is fixed to the skin of an individual and the ostomy bag allows the waste to drain from a stoma into the pouch, while protecting the surrounding skin from contamination by the waste.

Ostomy bags should be air- and water-tight and they should allow the individual to lead an active normal lifestyle that can include all forms of sports and recreation. Generally there is a need to make ostomy bags discrete and secure.

The need to provide discrete ostomy bags must be balanced with the need to provide a sufficiently large collection bag so that unexpected deposits can be accommodated by the bag. In addition, the mounting plate must provide a secure attachment to the skin of an ostomate, but it must also be discrete and allow for the ostomy bag to be removed for emptying or disposal. Typically, ostomy bags are emptied at least once per day.

The flange which forms a mounting plate is commonly manufactured of a hydrocolloid and it is coated with an adhesive which serves to attach the ostomy bag to the skin.

Secure attachment of the ostomy bag to the skin is of great importance to the user and to the functioning of the product. The level of adhesion, however, varies from product to product and also from person to person, with different skin types and conditions. Loss of, or declines in, adhesion can have potentially difficult and embarrassing consequences for an ostomate, due to the nature of the waste in the pouch and unpredictable output of effluent from the stoma.

In addition to lack of adhesion in some cases, abdominal and peri-stomal irregularities pose another major concern; such irregularities, either as a result of herniation, surgery or anatomical deformity can further increase the risk of pouch detachment due to decreased adhesive contact area and difficulty in application. Thus, ostomates frequently feel that additional security is needed.

Flange extenders for ostomy bags are known. They attempt to address this issue. They are generally arc-shaped pads, typically manufactured of hydrocolloid, which are placed around the peripheral edge of the flange of an ostomy bag to provide an increased area for adhesion. The typical arc shape is based on the circular or near- circular flange shape itself, around which it is applied.

These known flange extenders, partly overlap the flange and provide additional adhesive support in the area immediately around the flange periphery. This goes some way to address the problem of a secure attachment. However, it can make the flange of an ostomy bag difficult for a user to remove when changing ostomy bags. The need to change an ostomy bag frequently means a continued cycle of application and removal of the baseplate and flange extender. However, removal of a flange extender, for example to allow cleaning of the skin surrounding a stoma, can lead to skin irritation, skin thinning, inflammation, redness, pain and make the compromised skin more susceptible to infection and further damage. Therefore, there is a need to facilitate easy removal of a flange extender.

In addition, flange extenders while providing additional security are not traditionally designed to help promote healthy peri-stomal skin which is exposed to constant application and removal of stoma care devices.

The present invention seeks to provide a flange extender which addresses one or more of the problems presented by prior art arrangements. In particular, the present invention seeks to provide a flange extender which may help to facilitate removal and thereby maintain or improve peri-stomal skin condition.

Summary of the Invention

Remarkably, it has now been found that removal of a flange extender can be facilitated by including at least one removal tab that can be gripped by a user to assist in peeling a flange extender away from the skin of a user. Although the removal tab facilitates removal, the flange extender still provides a secure attachment, which is discrete and does not compromise on comfort for the user.

In accordance with the present invention, there is provided a flange extender for an ostomy bag, wherein the flange extender can be used to extend the flange of an ostomy bag, thereby increasing security of the connection between a user and the ostomy bag and the flange extender has at least one removal tab which is substantially non-adhesive and substantially does not adhere to the skin of a user, thereby facilitating removal of the flange extender from a user after use. Preferably, the flange extender has only one removal tab. Alternatively, the flange extender has two or more removal tabs. For example, the flange extender has two or three removal tabs.

Preferably, the removal tab has a width of about 2mm to about 20mm.

Preferably, the removal tab has a width of about 5mm to about 15mm.

Most preferably, the removal tab has a width of about 10mm.

Preferably, the removal tab has a length of about 2mm to about 20mm

Preferably, the removal tab has a length of about 5mm to about 15mm.

Most preferably, the removal tab has a length of about 10mm.

Preferably, the removal tab is approximately rectangular, or approximately triangular. Preferably, it has one or more rounded corners. This provides the advantage that it does not become caught, for example on clothing.

In one embodiment, the removal tab has a shape substantially defined by a circular arc or great arc.

Preferably, the flange extender can be produced in one of a multitude of geometries and dimensions to meet the needs for its intended application within ostomy and may also be tailored to a particular pouch or flange style. In an embodiment, the flange extender is curved or arcuate. For example, two or three or four flange extenders can be arranged together end to end to form an annulus. The maximum width of the flange extender is the difference between the radius of the outer edge of the annulus and the radius of the inner edge of the annulus.

Preferably, the flange extender of the invention has a maximum width of about 20mm to about 50mm. More preferably, the flange extender of the invention has a maximum width of about 25mm to about 45mm. Most preferably, the flange extender of the invention has a maximum width of about 30mm. This provides the advantage of an increased area for adhesion and this provides added security.

Preferably, the flange extender has rounded corners. This provides the advantage that they do not catch, for example on clothing.

Preferably, the removal tab is located at a first end of the flange extender. More preferably, a first removal tab is located at a first end of the flange extender and a second removal tab is located at second end of the flange extender, axially opposite to the first end. In an embodiment, a third removal tab is located between the first and second removal tabs, for example the third removal tab adjoins a long side of the flange extender.

Preferably, the removal tab(s) are located at the periphery of the flange extender. Preferably, one or more tabs are provided. For example, two, three or four tabs are provided. For convenience, they can be provided at one or more ends of the flange extender or they can be provided at one or more of any locations around the periphery of the flange extender. For example, a removal tab is located at the apex of the curvature of the flange extender; and / or at one end of the flange extender; and / or at both opposing end of the flange extender; and / or surrounding the entire periphery of the flange extender.

Preferably, the flange extender further comprises an adhesive coating. Preferably, the adhesive is acrylic based or silicone-based or PU-based. More preferably, the adhesive is acrylic based. Preferably, the adhesive coating is applied to at least a body facing surface of the flange extender, but it is not applied to the removal tab. Alternatively, the adhesive coating is applied to the removal tab, but the adhesive on the removal tab is covered so that the removal tab is incapable of adhering to the skin of a user.

In an alternative embodiment, the composition of the flange extender itself provides an adhesive. According to this embodiment, the removal tab is of a different composition or the removal tab is covered so that the removal tab is incapable of adhering to the skin of a user.

Preferably, the flange extender further comprises at least one easy-release liner. The easy-release liner covers the adhesive until the flange extender is ready for use. Just before use, the easy release liner can be peeled away to expose the adhesive. This provides the advantage of protecting the adhesive until it is ready for use.

Preferably, the easy release liner comprises a tab which does not adhere to the adhesive. This provides the advantage that the tab can be easily gripped and facilitates removal of the easy-release liner to expose the adhesive.

Preferably, adhesive is applied to the body facing surface of the flange extender. More preferably, adhesive is applied to both the body facing surface and an ostomy bag facing surface of the flange extender. Such an adhesive may take the form a patterned adhesive mesh or perforated adhesive sheet.

Preferably, at least one easy release liner covers the adhesive on the body facing surface of the polyurethane film or easy release liners cover adhesive on both the body facing surface and an ostomy bag facing surface of the flange extender until the flange extender is ready for use. Just before use, the easy release liner or liners can be peeled away from the flange extender surface or both the body facing surface and an ostomy bag facing surface of the flange extender to expose the adhesive. This provides the advantage of protecting the adhesive until it is ready for use.

Preferably, the flange extender comprises hydrocolloid.

Preferably, the flange extender comprises about 95.0% to about 99.99% hydrocolloid by weight.

Preferably, the flange extender comprises honey. In this regard, the composition of the flange extender has therapeutic properties and helps to promote healthy skin around a stoma. Preferably, the honey is medical grade honey. More preferably, the honey is medical grade Manuka honey.

In one embodiment, the adhesive comprises honey or honey is applied to the flange extender as a coating.

In an alternative embodiment, the flange extender comprises about 0.01% to about 2.0% honey by weight. More preferably, the flange extender comprises about 0.1- 1.0% honey by weight.

Advantageously, it has been found that the incorporation of honey into a flange extender provides anti-bacterial and anti-inflammatory properties to the skin of an ostomate. These advantages provide increased comfort for a user.

In a preferred embodiment, after removal of the easy release liner or liners, the flange extender comprises a composition of hydrocolloid and medical grade Manuka honey, and no other materials.

In an alternative embodiment, the flange extender comprises an ultra-thin highly conformable support film wherein the ultrathin support film is selected from a polyurethane film, polyvinylchloride film, polyester film and vinyl film, and the film has a thickness of about 5pm to about 200pm . Preferably, the ultra-thin support film has an adhesive applied to at least one of a body facing surface and an ostomy bag facing surface.

Advantageously, the moisture transmission rate is remarkably high compared to known flange extenders and this makes the flange extender more comfortable for a user to wear for extended periods. In addition, the thickness of the support film or flange extender of this embodiment of the invention is remarkably thin compared to known flange extenders. This has the advantage of assisting with ensuring that the flange extender of the invention does not catch on clothing of a user and this prevents the edges of the support film or flange extender being rolled away from the skin of a user at its edges.

Preferably, the ultrathin support film is ultrathin polyurethane film.

Preferably, the ultrathin support film has a thickness of about 5pm to about 100pm, more preferably, the ultrathin support film has a thickness of about 5pm to about 50pm, even more preferably the ultrathin support film has a thickness of about 5pm to about 10pm, most preferably the ultrathin support film has a thickness of about 7pm.

Advantageously, it has been found that a flange extender comprising an ultrathin support film according to the invention exhibits high levels of extensibility and is highly breathable. These advantages provide increased comfort for a user.

Preferably, the moisture vapour transmission rate (MVTR) value of the ultrathin support film is in the range of about 500 g/m2/24h to about 5000 g/m2/24h. More preferably, it is at least (equal to or greater than) 2000g/m2/24h. For example, in an embodiment it is 2444.1 g/m2/24h.

Preferably, the film is transparent or translucent. This provides the advantage that in use the skin where the flange extender is placed can be inspected. In addition, it provides the advantage of maximum discretion for a user.

Preferably, the adhesive applied to the ultrathin support film is acrylic based or silicone-based or PU-based. More preferably, the adhesive is acrylic based.

Preferably, the adhesive applied to the ultrathin support film has a thickness of about 0.2pm to about 2pm, more preferably, the adhesive has a thickness of about 0.8pm to about 1.2pm, even more preferably the adhesive has a thickness of about lpm.

Preferably, the flange extender is incorporated within the flange design of an ostomy bag and is integral with the ostomy bag. In this embodiment, the flange extender is applied to the flange of an ostomy bag and in use, a user is simply required to apply the flange extender to the skin.

Alternatively, the flange extender may be provided separately for use with an ostomy bag. In this embodiment, in use, a user is required to apply the flange extender to the skin and also to the flange of an ostomy bag. This can be achieved by applying the flange extender to the skin of an ostomate first followed by attachment of the flange extender to the flange of an ostomy bag. Alternatively, the flange extender is attached to the flange of an ostomy bag followed by attachment of the flange extender to the skin of an ostomate.

Preferably, a flange extender according to the invention is stacked and packaged in a package. This has the advantage of protecting the flange extender.

Preferably, the package is of a moulded or vacuum formed plastics material, in which the flange extender is provided. Preferably, the package contains one or more flange extenders. More preferably, the package contains two or three or more flange extenders according to the invention, for example, about 10, about 20 or about 30.

Brief Description of the Drawings

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

Figure 1 shows a flange extender according to the invention. In the drawing the parts are identified by numbering as follows: (1): Flange, (2): Stoma hole, (3): pouch, (4): flange extender, (5): two flange extenders, (6): three flange extenders, and (9): removal tab;

Figure 2 a flange extender (4) according to the invention having a tab (8) for easy removal of the release liner (7), and a removal tab (9) for easy removal of the flange extender after use; Figure 3 shows illustrations of flange extenders (4) of the invention having one or more release liners (7) having release liner removal tabs (8) and flange extender removal tabs (9); and

Figure 4 shows illustrations of flange extenders (4) of the invention having one or more release liners (7) having release liner removal tabs (8) and flange extender removal tabs (9).

Detailed Description of the Invention

It will be appreciated that aspects, embodiments and preferred features of the invention have been described herein in a way that allows the specification to be written in a clear and concise way. However, it will be appreciated that the scope of the invention may include embodiments having combinations of all or some of the features described. Unless circumstances clearly dictate otherwise, aspects, embodiments and preferred features can be variously combined or separated in accordance with the invention. In a preferred embodiment, a device in accordance with the invention comprises all aspects of the invention.

The word "about" is taken to mean optionally plus or minus 20%, more preferably optionally plus or minus 10%, even more preferably optionally plus or minus 5%, even more preferably optionally plus or minus 2.5%, most preferably optionally plus or minus 1%.

Within the context of this specification the word "comprises" is taken to mean "includes, among other things". It is not intended to be construed as "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%. Within the context of this specification, a "flange extender" is intended to mean a discrete device applied to a user separately from the flange of an ostomy bag to extend the area on a user's skin that is adhered to and to provide additional adhesive support in the area around the flange periphery.

Details of flange extenders according to the invention for use with ostomy bags are shown in Figures 1 to 4.

The ostomy bags have a flange (1), a stoma hole (2) and a pouch (3).

The flange extender (4) (5) or (6) can be used to extend the flange (1) of an ostomy bag, thereby increasing security of the connection between a user and the ostomy bag. The flange extender (4) (5) or (6) has at least one removal tab (9) which is non-adhesive and does not adhere to the skin of a user, thereby facilitating removal of the flange extender (4) (5) or (6) from a user after use.

The flange extender (4) (5) or (6) shown in Fig 4(a) has only one removal tab. Alternatively, the flange extenders shown in Fig 4(b) or 4(c) have two removal tabs. The flange extender shown in Fig 4(d) has a continuous removal tab substantially around its periphery.

The removal tab (9) has a width of about 2mm to about 20mm.

The removal tab (9) has a length of about 2mm to about 20mm.

The removal tab(s) (9) are located at the periphery of the flange extender. In an embodiment one or a number of tabs (9) are provided. For convenience, they can be provided at one or more ends of the flange extender or they can be provided at one or more of any locations around the periphery of the flange extender. As shown in Figure 4(a), in an embodiment, the removal tab (9) is located at the apex of the curvature of the flange extender. In Figure 4(b) a further embodiment is shown wherein the removal tab is located at one end of the flange extender. In Figure 4(c) a further embodiment is shown wherein the removal tab is located at both opposing end of the flange extender. In Figure 4(d) a further embodiment is shown wherein the removal tab is located surrounding the entire periphery of the flange extender.

The flange extenders (4) (5) or (6) are manufactured of PU film. They adhere to the skin of an ostomate and to the flange (1) of an ostomy bag.

Adhesive is applied to the PU film and the adhesive is covered by a release liner (7).

A release liner (7) covers the surface to be attached to the skin. The easy release liner (7) can be peeled away prior to use to expose the adhesive. This provides the advantage of protecting the adhesive until it is ready for use.

The easy release liner (7) comprises a tab (8) which does not adhere to the adhesive. This provides the advantage that the tab (8) can be easily gripped and facilitates removal of the easy-release liner (7) to expose the adhesive on the flange extender (4).

The flange extender (4) can be produced in a multitude of geometries and dimensions to meet the needs for its intended application within ostomy and may also be tailored to a particular pouch (4) or flange style (1). Examples of possible flange extenders (4) are shown in Figure 3.

In one embodiment, the flange extender (4) (5) or (6) is incorporated within the flange (1) design of an ostomy bag and is integral with the ostomy bag. In this embodiment, the flange extender (4) (5) or (6) is applied to the flange (1) of an ostomy bag and in use, a user is simply required to apply the flange extender (4) (5) or (6) to the skin.

Alternatively, the flange extender (4) (5) or (6) may be provided separately for use with an ostomy bag. In this embodiment, in use, a user is required to apply the flange extender (4) (5) or (6) to the skin and the flange (1) of an ostomy bag. This can be achieved by applying the flange extender (4) (5) or (6) to the skin of an ostomate first followed by attachment of the flange extender (4) (5) or (6) to the flange (1) of an ostomy bag. Alternatively, the flange extender (4) (5) or (6) is attached to the flange (1) of an ostomy bag followed by attachment of the flange extender (4) (5) or (6) to the skin of an ostomate.

In one embodiment, the flange extender (4) (5) or (6) is sealed in a sachet prior to use. The sachet contains two or three flange extenders (4) (5) or (6).

To manufacture a flange extender (4) (5) or (6), a PU film composition is provided and cut to size. Adhesive is applied to the film so that it has an adhesive surface. An easy release Iiner (7), having a tab (8) for easy removal of the release Iiner (7) is applied to the adhesive surface.

The above described embodiments have been given by way of example only, and the skilled reader will naturally appreciate that many variations could be made thereto without departing from the scope of the claims.

Claims

1. A flange extender for an ostomy bag, wherein the flange extender can be used to extend the flange of an ostomy bag, thereby increasing security of the connection between a user and the ostomy bag and the flange extender has at least one removal tab which is substantially non-adhesive and substantially does not adhere to the skin of a user, thereby facilitating removal of the flange extender from a user after use.

2. A flange extender according to claim 1, wherein the flange extender has only one removal tab.

3. A flange extender according to claim 1, wherein the flange extender has two or more removal tabs.

4. A flange extender according to any one of the preceding claims wherein the removal tab has a width of about 2mm to about 20mm.

5. A flange extender according to any one of the preceding claims wherein the removal tab has a length of about 2mm to about 20mm.

6. A flange extender according to any one of the preceding claims wherein the removal tab is approximately rectangular, or approximately triangular.

7. A flange extender according to any one of claims 1 to 5 wherein the removal tab has a shape substantially defined by a circular arc or great arc.

8. A flange extender according to any one of the preceding claims wherein the flange extender is curved or arcuate.

9. A flange extender according to any one of the preceding claims wherein two or three or four flange extenders can be arranged together substantially end to end or overlapping to form an annulus.

A flange extender according to any one of the preceding claims wherein the flange extender has a maximum width of about 20mm to about 50mm.

A flange extender according to any one of the preceding claims wherein the flange extender has rounded corners.

A flange extender according to any one of the preceding claims wherein a removal tab is located at a first end of the flange extender.

A flange extender according to any one of the preceding claims wherein a first removal tab is located at a first end of the flange extender and a second removal tab is located at second end of the flange extender, axially opposite to the first end.

A flange extender according to claim 13 wherein a third removal tab is located between the first and second removal tabs, optionally wherein the third removal tab adjoins a long side of the flange extender.

A flange extender according to any one of the preceding claims wherein the removal tab(s) are located at the periphery of the flange extender.

A flange extender according to any one of the preceding claims wherein the flange extender further comprises an adhesive coating.

A flange extender according to claim 16 wherein the adhesive is acrylic based or silicone-based or PU-based.

A flange extender according to claim 16 or 17 wherein the adhesive coating is applied to at least a body facing surface of the flange extender, but it is not applied to the removal tab.

A flange extender according to claim 16 or 17 wherein the adhesive coating is applied to at least a body facing surface of the flange extender and the removal tab, but the adhesive on the removal tab is covered so that the removal tab is incapable of adhering to the skin of a user.

20. A flange extender according to any one of claims 1 to 15 wherein the composition of the flange extender is itself adhesive.

21. A flange extender according to claim 20 wherein the removal tab is of a different composition to the rest of the flange extender or the removal tab is covered so that the removal tab is incapable of adhering to the skin of a user.

22. A flange extender according to any one of claims 1 to 21 wherein the flange extender further comprises at least one easy-release liner, which covers the adhesive until the flange extender is ready for use.

23. A flange extender according to claim 22 wherein the easy release liner comprises a tab which does not adhere to the adhesive.

24. A flange extender according to any one of claims 1 to 23 wherein adhesive is applied to only the body facing surface of the flange extender or both the body facing surface and an ostomy bag facing surface of the flange extender.

25. A flange extender according to any one of the preceding claims wherein the flange extender comprises hydrocolloid.

26. A flange extender according to claim 25 wherein the flange extender comprises about 95.0% to about 99.99% hydrocolloid by weight.

27. A flange extender according to any one of the preceding claims wherein the flange extender comprises honey, optionally wherein the honey is medical grade honey, optionally medical grade Manuka honey.

28. A flange extender according to any one of claims 1 to 24 wherein the flange extender comprises an ultra-thin highly conformable support film wherein the ultrathin support film is selected from a polyurethane film, polyvinylchloride film, polyester film and vinyl film, and the film has a thickness of about 5μηι to about 200 m.

29. A flange extender according to claim 28 wherein the ultrathin support film has a thickness of about 5pm to about ΙΟΟμπι.

30. A flange extender according to claim 28 or claim 29 wherein the ultrathin support film has a thickness of about 5pm to about 50pm.

31. A flange extender according to any one of claims 28 to 30 wherein the ultrathin support film has a thickness of about 5μηι to about ΙΟμιτι.

32. A flange extender according to any one of claims 28 to 31 wherein the ultrathin support film has a thickness of about 7pm.

33. A flange extender according to any one of claims 28 to 32 wherein the moisture vapour transmission rate (MVTR) value of the ultrathin support film is in the range of about 500 g/m2/24h to about 5000 g/m2/24h.

34. A flange extender according to any one of the preceding claims wherein the flange extender is transparent or translucent.

35. An ostomy bag comprising an integral flange extender according to any one of the preceding claims.

36. A package comprising a flange extender according to any one of claims 1 to 34.

37. A package according to claim 36 which is of a moulded or vacuum formed plastics material, in which the flange extender is provided.

38. A package according to claim 36 or 37 wherein the package contains one or more flange extenders, optionally wherein the package contains two or three or more flange extenders, optionally wherein the package contains about 10, about 20 or about 30 flange extenders according to any one of claims 1 to 34.

39. A flange extender for an ostomy bag substantially as described herein.