GB2431355A

GB2431355A - Ostomy appliance coupling system

Info

Publication number: GB2431355A
Application number: GB0615225A
Authority: GB
Inventors: Neil Philip Wiltshire; Eric Davison; John Edwards
Original assignee: Salts Healthcare Ltd
Current assignee: Salts Healthcare Ltd
Priority date: 2005-10-18
Filing date: 2006-08-01
Publication date: 2007-04-25
Anticipated expiration: 2026-08-01
Also published as: GB0521096D0; GB0615225D0; GB2431355B

Abstract

A two piece ostomy appliance 10 is described which has a pouch flange (30, fig.3) comprising an outer periphery and an opening 18; a pouch 24 for the receipt of waste is secured thereto. On a face of the pouch flange distant from the pouch, adhesive (36, fig.3) is provided for adhering the pouch flange to a bodyside flange 12. The bodyside flange is provided with an opening 18 and a hydrocolloid wafer 14 for securing the ostomy appliance to the body of a user around their stoma. The bodyside flange further includes a locating formation 16 around at least a part of the opening for co-operation with the opening of the pouch flange. The locating formation may be situated around only part of the opening, within a certain angular range, or may be annularly situated around the whole of the opening. Preferably, the pouch flange also includes a locating formation around at least a part of the opening for co-operation with the locating formation on the bodyside flange. The bodyside flange and the pouch flange locating formations may also include matching tapers so as to provide a close fit when the flanges are brought together.

Description

Title: Ostomy Appliance DescriDtion of Invention The invention relates to

an ostomy appliance and in particular to a coupling system incorporated into an ostomy appliance which comprises a first part for securing to the body of the user and a pouch releasably securable to the bodyside part for receipt of waste.

Such ostomy appliances are known and are referred to as two piece appliances. The manner of securing the pouch to the bodyside part can in the prior art be adhesive or by means of some form of engagement system with co-operating formations on the bodyside part and the pouch. Many of the prior art products suffer from the problem that the users, who are often elderly and thus have relatively poor eyesight and/or are not very dextrous, have difficulty in aligning the pouch with the bodyside part to ensure good connection. This can lead to leaks and hence poor customer satisfaction.

It is an aim of the present invention to provide an alternative two piece ostomy appliance which seeks to mitigate the above described problem.

According to a first aspect of the present invention there is provided a two piece ostomy appliance having: a pouch flange with an outer periphery and an opening and secured thereto a pouch for receipt of waste and, on a face of the flange distant from the pouch, adhesive for adhering the pouch flange to the bodyside flange, and a bodyside flange with an opening and a hydrocolloid wafer secured thereto for securing the appliance to the body of a user around their stoma, wherein the bodyside flange includes a locating formation around at least a part of the opening for co-operation with the opening of the pouch flange.

A11592GB The invention provides the advantage that the location formation on the bodyside flange is provided to assist the user in locating the pouch flange accurately with respect to the bodyside flange by feel rather than sight, and to do so positively.

Conveniently the locating formation of the bodyside flange is around the opening for a distance in the range 90 to 270 degrees. More preferably the locating formation of the bodyside flange is around the opening for a distance in the range 150 to 210 degrees. More preferably still the locating formation of the bodyside flange is around the opening for a distance in the range 170 to degrees.

The locating formation of the bodyside flange may however extend around the whole of the opening, i.e. be annular.

The pouch flange may further include a locating formation around at least a part of the opening for co-operation with the locating formation on the bodyside flange.

The locating formation on the pouch flange may be annular.

The adhesive may cover the face of the pouch flange from adjacent the opening radially outwards towards its outer edge. Alternatively the adhesive covers the face of the pouch flange from a location at least 2mm from the opening radially outwards towards its outer edge, leaving an adhesive free zone of at least 2mm radius around the opening. In a further alternative the adhesive covers the face of the pouch flange from a location about a third of the way from the opening to its outer periphery radially outwards towards its outer periphery, leaving an adhesive free zone from the opening to the location about a third of the way to the outer periphery.

Al 1592GB The adhesive covers the face of the pouch flange to a location about two thirds of the way from the opening to the outer periphery.

The locating formation on the pouch flange may include a tapering lead-in on the side of the pouch and the locating formation on the bodyside flange may include a tapering chute on the side distant from the hydrocolloid wafer, the tapering lead-in and tapering chute having matching tapers such that the chute is a close fit within the lead-in when the pouch flange and the bodyside flange are brought together.

The tapering lead-in on the pouch flange may have a flexible seal portion at its free end which is displaced by the chute when the pouch flange and the bodyside flange are brought together.

The locating formation on the pouch flange may alternatively include a generally U-shaped formation which provides a groove facing away from the pouch and the locating formation on the bodyside flange may then include an upstand on the side distant from the hydrocolloid wafer shaped to be a close fit within the groove when the pouch flange and the bodyside flange are brought together.

In such cases the locating formation on the pouch flange may further include a protuberance on the free end of the generally U-shaped formation and the locating formation on the bodyside flange then further include an undercut on the upstand for the receipt of the protuberance when the pouch flange and the bodyside flange are brought together.

In a further alternative the locating formation on the pouch flange may include a generally U-shaped formation which provides a groove facing away from the pouch and the locating formation on the bodyside flange then includes an upstand on the side distant from the hydrocolloid wafer shaped to be a close A11592GB fit within the groove on the radially outer side and has a flexible seal portion on the radially inner side which is displaced by the groove when the pouch flange and the bodyside flange are brought together.

Conveniently the pouch flange may further include belt loops on opposite sides of the flange for attachment of a belt to further secure the appliance to the user.

Embodiments of ostomy appliances according to the invention will now be described, by way of example only, with reference to the accompanying drawings in which: Figure 1 is a view of single use (non-drainable) ostomy appliance according to the invention from the bodyside; Figure 2 is a view of a drainable ostomy appliance according to the invention from the bodyside; Figure 3 shows a section through (a) and detail of (b) a first embodiment of a pouch flange according to the invention; Figure 4 shows sections through (a & c) and detail of (b & d) two bodyside flanges for use with the pouch flange of Figure 3; Figure 5 shows a section through (a) and detail of (b) a modified version of the pouch flange of Figure 3; Figure 6 shows a section through (a) and detail of (b) a further modified version of the pouch flange of Figure 3; Figure 7 shows a section through (a) and detail of (b) a further modified version of the pouch flange of Figure 3, having the features incorporated in both Figures 5 and 6; Figure 8 shows a section through (a) and detail of (b) a second embodiment of a pouch flange according to the invention; Figure 9 shows a section through (a) and detail of (b) a bodyside flange for use with the pouch flange of Figure 8; Al 1592GB Figure 10 shows a section through (a) and detail of (b) a modified version of the pouch flange of Figure 8; Figure 11 shows a section through (a) and detail of (b) a third embodiment of a pouch flange according to the invention; Figure 12 shows a section through (a) and detail of (b) a bodyside flange for use with the pouch flange of Figure 11; Figure 13 shows a section through (a) and detail of (b) a modified version of the pouch flange of Figure 11; Figure 14 shows a section through (a) and detail of (b) a modified version of the bodyside flange of Figure 12; Figure 15 shows a view of a single use (non drainable) ostomy appliance according to yet another embodiment from a) the body side and b) in cross section; and Figure 16 shows a) a plan view and b) a cross section through a bodyside flange for use with the pouch of Figure 15.

Referring first to Figure 1, a two piece ostomy appliance 10 is viewed from the bodyside. The two piece appliance 10 comprises a bodyside flange 12 secured to a hydrocolloid wafer 14 (shown in chain lines only in order to illustrate the further components) for securing to the users body in conventional manner around their stoma. The bodyside flange 12 includes an annular locating formation 16 around a central opening 18 and, on the side of the flange distant from the hydrocolloid wafer 14, adhesive 20 (shown hatched). The two piece appliance 10 further comprises a pouch flange (not shown) with secured to it a pouch 24 for receipt of waste. The pouch 24 is of the closed (single use) variety rather than being drainable. The pouch flange includes an annular locating formation 26 (not visible in Figure 1), around a central opening 18, for co-operation with the annular locating formation 16 of the bodyside flange 12, and belt loops 28 on either side to provide an additional form of securing the appliance 10 in place.

Al 1592GB Referring now to Figure 2 a two piece appliance 10' is shown and parts common to the appliance 10 of Figure 1 are like referenced. The only difference between the appliance 10 of Figure 1 and the appliance 10' of Figure 2 is that the pouch 24' of the appliance 10' is drainable.

The annular locating formations 16, 26 incorporated into the two piece appliances 10 and 10' are parts of the bodyside and pouch flanges and these may be of any of the forms discussed below with reference to Figures 3 to 16, or indeed any other forms falling within the scope of the present invention.

Typically the flanges will be injection moulded from suitable plastics materials.

Referring now to Figure 3, a pouch flange 30 is illustrated in (a) section through the belt loops 28 and (b) a portion of it in greater detail. The pouch flange 30 is roughly annular, (although it will have indents on two sides as shown in Figures 1 and 2, if belt loops are included as illustrated), and in use the pouch 24 is attached to the uppermost side shown in the Figure. The pouch flange 30 has an outer periphery (not shown) beyond which the belt loops extend and a locating formation in the form of a tapering lead-in 34 around the central opening 18. Adhesive 36 is provided on the annular surface between the outer periphery and the opening 18 on the side distant from the pouch location. The adhesive 36 covers this surface from close to the opening 18 to a distance about half way towards the outer periphery. The tapering lead-in 34 is set at an angle of 100 degrees to the annular surface and protrudes about 1.5mm above that surface.

Referring now to Figure 4, two variations of a bodyside flange 40, 40' are shown, and when the bodyside part is assembled the hydrocolloid wafer (not shown) is secured to the lower side as shown in the Figure. The flanges 40 and 40' are annular, with a tapering thickness towards their outer edges. The flange 40 has a tapering chute 42 protruding 3mm from the outer annular surface 44 of the flange, in use away from the user's body. The flange 40' has Al 1592GB a tapering chute 42' protruding 5mm from the annular surface of the flange, in use away from the user's body. The chutes 42 and 42' taper at the same angle as the tapering lead-in 34 of the pouch flange, in this case 100 degrees.

When the pouch flange 30 is used with the bodyside flange 40 or 40' the pouch flange 30 is readily located by the user, by aligning the pouch flange 30 such that the chute 42 or 42' is received in the lead-in 34. The matching tapers, in this case at 100 degrees, but any other suitable angle can be made, assist in providing a seal, but the appliance is retained in place primarily by the adhesive 36 on the pouch flange 30 adhering to the outer annular surface 44 or 44' of the bodyside flange 40 or 40'.

Referring now to Figure 5, a modified version 30' of the pouch flange 30 is shown in (a) section through the belt loops 26 and (b) in greater detail, with parts common to the pouch flange 30 being like referenced. The only difference between the pouch flange 30 and the modified pouch flange 30' being that the adhesive 36' does not start adjacent the opening 18, but rather covers an area of the flange surface starting about 6.5mm from the opening 18 to a distance about two thirds of the way towards the outer periphery. An adhesive free zone 37 surrounds the opening 18. This is provided to enable users to locate the pouch flange 30' on the bodyside flange 40 or 40' more easily without the adhesive 36' actually adhering to the surface of the bodyside flange 40 or 40', thus permitting repositioning if necessary, before the user firmly presses the pouch flange onto the bodyside flange to cause the adhesive to adhere.

Referring now to Figure 6, a further modified version 30" of the pouch flange 30, in which again like parts are like referenced. The only difference between the pouch flange 30 and the modified flange 30" is that the tapered lead-in 34' has a flexible seal formation 35 protruding from it's free end. The flexible seal is displaced by contact with the chute 42 or 42' of the bodyside flange 40 or A11592GB 40' when the pouch flange is engaged with it, and improves the level of sealing between the two flanges 30" and 40 or 40'.

Referring now to Figure 7, a further modified version 30" of the pouch flange 30 includes the features of both the previously described modified flanges 30' and 30", with like parts being like referenced. Thus the pouch flange 30" includes an adhesive free zone 37 and a flexible seal 35.

Referring now to Figure 8, a second embodiment of a pouch flange 80 according to the invention is illustrated in (a) section through the belt loops 28 and (b) in greater detail. The pouch flange 80 is roughly annular, (although it will have indents on two sides as shown in Figures 1 and 2, if belt loops are included as illustrated), and when assembled with the pouch 24 or 24' the pouch will be located on the upper side as shown in the Figure. The pouch flange 80 has an outer periphery and a locating formation 83 which is roughly U-shaped in cross-section and provides an annular groove 84 around the central opening 18. The annular groove 84 is shaped to accept a co-operating formation on the bodyside flange, as will be described below. The pouch flange 80 also includes adhesive 36 provided on the annular surface between the outer periphery and the opening 18 on the side distant from the pouch location. The adhesive 86 covers this surface from close to the opening 18 to a distance about two thirds of the way towards the outer periphery.

Referring now to Figure 9, a bodyside flange 90 for use with the pouch flange 80 is illustrated in (a) section and (b) greater detail. When the bodyside part is assembled the hydrocofloid wafer (not shown) is secured to the lower side of the bodyside flange 90 as shown in the Figure. The flange 90 is annular, with a tapering thickness towards its outer edge. The flange 90 has a locating formation in the form of an upstand 92 protruding about 3.5mm from the outer annular surface 94 of the flange, in use away from the user's body. The upstand 92 is shaped to be a close fit within the groove 84 provided by the Al 1592GB generally U-shaped locating formation 83 of the pouch flange described above with reference to Figure 8.

When the pouch flange 80 is used with the bodyside flange 90 the pouch flange 80 is readily located by the user, by aligning the pouch flange 80 such that the upstand 92 on the bodyside flange 90 is received in the groove 84 of the locating formation 83 of the pouch flange 80. The matching shapes of the groove 84 and the upstand 92 assist in providing a seal, but the appliance is retained in place primarily by the adhesive 86 on the pouch flange 80 adhering to the outer annular surface 94 of the bodyside flange 90.

Referring now to Figure 10, a modified version 80' of the pouch flange 80 is shown in (a) section and (b) in greater detail, with parts common to the pouch flange 80 being like referenced. The only difference between the pouch flange 80 and the modified pouch flange 80' being that the adhesive 86' does not start adjacent the opening 18, but rather covers an area of the flange surface starting about 6.5mm from the opening 18 to a distance about two thirds of the way towards the outer periphery. An adhesive free zone 87 surrounds the opening 18.

Referring now to Figure 11, a further modified version 80" of the pouch flange 80, is illustrated in (a) section and (b) greater detail, and again like parts are like referenced. The only difference between the pouch flange 80 and the modified flange 80" is that the generally U-shaped locating formation 83' includes a protuberance 85 at it's free end facing in towards the groove 84.

The protuberance 85 is provided to co-operate with an undercut provided on the bodyside flange as will be described below.

Referring now to Figure 12, a modified version 90' of the bodyside flange 90 is illustrated in (a) section and (b) greater detail, with parts common to the bodyside flange 90 being like referenced. The only difference between the Al 1592GB bodyside flange 90 and the modified version 90's an undercut 95 provided on the surface of the upstand facing the opening 18. The undercut 95 is provided for receipt of the protuberance 85 of the corresponding pouch flange 80", such that when the pouch flange 80" is located and secured to the bodyside flange 90' the sealing provided by the locating formations is improved.

Referring now to Figure 13, a further modified version 80" of the pouch flange is illustrated in (a) section and (b) greater detail, with parts common to previously described version being like referenced. Essentially the pouch flange 80" includes the additional features of both pouch flanges 80' and 80", i.e. both the adhesive free zone 87 and the protuberance 85.

Referring now to Figure 14, a further modified version 90" of the bodyside flange 90 is illustrated in (a) section and (b) greater detail, with parts common to previously described version being like referenced. The bodyside flange 90" includes an upstand 92" which is shaped to fit one side of the groove 84 of the pouch flange 80, this being the radially outer side, but not to fit the other side so closely. Instead the radially inner side of the upstand 92" has a flexible seal 96 which is slightly displaced by the groove 84 when the pouch flange is located in place. This displacement ensures a good seal between the two flanges 80 and 90".

Referring now to Figure 15, a two piece ostomy appliance 10' is viewed from the bodyside, and parts common with the two piece ostomy appliance 10 in Figure 1 are like referenced. In this embodiment the hydrocolloid wafer 14 secured to the body flange 12' has a much smaller central opening 18' such that the user can increase the size of the opening as appropriate for their own stoma (this can also be the case with all the previous embodiments). The bodyside flange 12', is shown in detail in Figure 16, and will be described further in relation to that Figure in due course.

A11592GB The pouch 24 has secured to it a pouch flange 22, but in this case it is only made of foam, and not of injection moulded plastics material as for the other flanges previously described. It should however be noted that a similar embodiment could include a plastic support ring as well as the foam. The pouch flange 22 has adhesive 20, shown hatched in Figure 15(a), on much of the surface distant from the pouch itself. However, an adhesive free zone 20' is provided immediately around the central opening 18.

Referring now to Figure 16 in particular, the bodyside flange 12' is annular with a tapering thickness towards its outer edge. The flange 12' has a tapering upstand 96 around a little more than half the circumference (about 190 degrees) of the central opening 18. In use the upstand 96 is intended to be below the patient's stoma.

The upstand 96 could extend around a different proportion of the opening 18.

Preferably it extends around a part of the opening in the range 90 to 270 degrees, and more preferably in the range 150 to 210 degrees.

In use, the bodyside flange 12' is affixed to the patient's skin around their stoma by means of the hydrocolloid wafer 14, the central opening 18' having been increased in diameter if appropriate. To affix the pouch 24 onto the bodyside flange 12', any release paper is removed from the adhesive 20 on the pouch flange 22, and the pouch flange 22 is brought up against the upstand 96 around the lower part of the patient's stoma. When the pouch flange 22 is up against the upstand 96 the lower part of the pouch flange 22 is pressed against the lower part of the bodyside flange 12' such that the adhesive 20 sticks to the bodyside flange 12', the remaining part of the pouch flange 22 is then rolled upwardly onto the remaining part of the bodyside flange 12' and pressed into place such that the adhesive 20 sticks to the bodyside flange 12'.

A11592GB It has been found that having an upstand 96 around only the lower part of the circumference of the stoma, along with a simple pouch flange 22 of foam only, rather than something which locates positively onto the bodyside flange 12', is much easier for the users to handle, but still provides an acceptable form of location.

In the above description the openings in the pouch and bodyside flanges are all described as being central, however, it will be understood that they need not be centrally located.

It has been found that adhesive free zones around the central openings of pouch flanges may be as small as 2mm radially from the central opening or as large as about half the distance between the central opening and the outer periphery. Thus adhesive free zones within this range may be incorporated into ostomy appliances according to the invention.

The materials from which the embodiments of the invention may be constructed are not limited in any way except by the properties of the materials themselves. However, examples of suitable materials are: for the pouches themselves one or more layers of ethylene vinyl acetate (EVA) and a barrier layer such as polyvinylidene chloride (PVDC); for foam elements, polyethylene foam; for the injection moulded plastic flanges, ethylene vinyl acetate (EVA) or polyehtylene.

When used in this specification and claims, the terms "comprises" and "comprising" and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or components.

A11592GB The features disclosed in the foregoing description, or the following 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.

A11592GB

Claims

Claims 1. A two piece ostomy appliance having: a pouch flange with an

outer periphery and an opening and secured thereto a pouch for receipt of waste and, on a face of the flange distant from the pouch, adhesive for adhering the pouch flange to the bodyside flange, and a bodyside flange with an opening and a hydrocolloid wafer secured thereto for securing the appliance to the body of a user around their stoma, wherein the bodyside flange includes a locating formation around at least a part of the opening for co-operation with the opening of the pouch flange.
2. A two piece ostomy appliance according to claim 1 wherein the locating formation of the bodyside flange is around the opening for a distance in the range 90 to 270 degrees.
3. A two piece ostomy appliance according to claim 2 wherein the locating formation of the bodyside flange is around the opening for a distance in the range 150 to 210 degrees.
4. A two piece ostomy appliance according to claim 3 wherein the locating formation of the bodyside flange is around the opening for a distance in the range 170 to 190 degrees.
5. A two piece ostomy appliance according to claim 1 wherein the locating formation of the bodyside flange is around the whole of the opening.
6. A two piece ostomy appliance according to anyone of the preceding claims wherein the pouch flange further includes a locating formation around at least a part of the opening for co-operation with the locating formation on the bodyside flange.

A11592GB
7. A two piece ostomy appliance according to claim 6 wherein the locating formation on the pouch flange is annular.
8. A two piece ostomy appliance according to any one of the preceding claims wherein the adhesive covers the face of the pouch flange from adjacent the opening radially outwards towards its outer edge.
9. A two piece ostomy appliance according to any one of claims 1 to 7 wherein the adhesive covers the face of the pouch flange from a location at least 2mm from the opening radially outwards towards its outer edge, leaving an adhesive free zone of at least 2mm radius around the opening.
10. A two piece ostomy appliance according to claim 9 wherein the adhesive covers the face of the pouch flange from a location about a third of the way from the opening to its outer periphery radially outwards towards its outer periphery, leaving an adhesive free zone from the opening to the location about a third of the way to the outer periphery.
11. A two piece ostomy appliance according to any one of claims 8, 9 or 10 wherein the adhesive covers the face of the pouch flange to a location about two thirds of the way from the opening to the outer periphery.
12. A two piece ostomy appliance according to claim 6 or any one of claims 7 to 11 as dependent on claim 6 wherein the locating formation on the pouch flange includes a tapering lead-in on the side of the pouch and the locating formation on the bodyside flange includes a tapering chute on the side distant from the hydrocolloid wafer, the tapering lead-in and tapering chute having matching tapers such that the chute is a close fit within the lead- in when the pouch flange and the bodyside flange are brought together.

A11592GB
13. A two piece ostomy appliance according to claim 12 wherein the tapering lead-in on the pouch flange has a flexible seal portion at its free end which is displaced by the chute when the pouch flange and the bodyside flange are brought together.
14. A two piece ostomy appliance according to claim 6 or any one of claims 7 to 11 as dependent on claim 6 wherein the locating formation on the pouch flange includes a generally U-shaped formation which provides a groove facing away from the pouch and the locating formation on the bodyside flange includes an upstand on the side distant from the hydrocolloid wafer shaped to be a close fit within the groove when the pouch flange and the bodyside flange are brought together.
15. A two piece ostomy appliance according to claim 14 wherein the locating formation on the pouch flange further includes a protuberance on the free end of the generally U-shaped formation and the locating formation on the bodyside flange further includes an undercut on the upstand for the receipt of the protuberance when the pouch flange and the bodyside flange are brought together.
16. A two piece ostomy appliance according to claim 6 or any one of claims 7 to 11 as dependent on claim 6 wherein the locating formation on the pouch flange includes a generally U-shaped formation which provides a groove facing away from the pouch and the locating formation on the bodyside flange includes an upstand on the side distant from the hydrocolloid wafer shaped to be a close fit within the groove on the radially outer side and has a flexible seal portion on the radially inner side which is displaced by the groove when the pouch flange and the bodyside flange are brought together.
17. A two piece ostomy appliance according to any one of the preceding claims wherein the pouch flange further includes belt loops on opposite sides A11592GB of the flange for attachment of a belt to further secure the appliance to the user.
18. A two piece ostomy appliance substantially as herein before described with reference to figures 1 or 2 of the accompanying drawings in combination with figures 3 and 4, or figures 4 and 5, or figures 4 and 6, or figures 4 and 7, or figures 8 and 9, or figures 9 and 10, or figures 11 and 12, or figures 11 and 13, or figures 8 and 14, or figures 15 and 16.
19. Any novel feature or novel combination of features described herein and/or in the accompanying drawings.

Al 1592GB