WO2013007262A1

WO2013007262A1 - Ostomy appliance having means for separating bag walls

Info

Publication number: WO2013007262A1
Application number: PCT/DK2012/050255
Authority: WO
Inventors: Lars Drøgemüller KJELDSEN; Leonard PIPER
Original assignee: Coloplast A/S
Priority date: 2011-07-08
Filing date: 2012-07-05
Publication date: 2013-01-17

Abstract

The current invention relates to an ostomy appliance comprising means for keeping the walls of the collecting bag separated and thereby reducing the risk of pancaking. Moreover, in particular,the current invention relates to means for reducing the risk of pancaking which also reduces the pull exerted on the collecting bag.

Description

OSTOMY APPLIANCE HAVING MEANS FOR SEPARATING BAG WALLS

TECHNICAL FIELD

The current invention relates to an ostomy appliance comprising means for keeping the walls of the collecting bag separated, thereby reducing the risk of pancaking.

Moreover, in particular, the current invention relates to means for reducing the risk of pancaking which also reduces the pull exerted on the collecting bag.

BACKGROUND

Ballooning and pancaking are two common issues relating to the use of ostomy appliances.

Ballooning occurs when there is a high pressure inside the collecting bag. This results in an inflated collecting bag which is uncomfortable, visibly disturbing and ultimately this may result in the ostomy appliance detaching from the user's skin because of the high pressure causing leakage.

Contrary to ballooning, pancaking occurs when there is a low pressure inside the collecting bag. The low pressure causes the walls of the collecting bag to be sucked together preventing output from the stoma from falling correctly into the collecting bag. Instead, the output will build up at the inlet opening of the collecting bag providing a build up that prevents further output from exiting the stoma. Ultimately, pancaking may cause the ostomy appliance to detach or even damage the stoma.

The following invention seeks to alleviate the issues caused by low pressure inside the collecting bag thereby avoiding pancaking.

BRIEF DESCRIPTION

The present invention relates to an ostomy appliance comprising a base plate having a proximal adhesive surface and a through-going hole extending in an axial direction through the base plate, the ostomy appliance further comprising a collecting bag arranged on the distal side of the base plate, the collecting bag comprising a proximal wall and a distal wall, where an opening is provided in the proximal wall for communication with the through-going hole, wherein the ostomy appliance further comprises a support member, wherein a first part of the support member is arranged and supported between the base plate and the collecting bag and a second part of the support member which has a distance from the first part of the support member along the axial direction of the ostomy appliance and engagement means are provided for engaging the second part of the support member to the distal wall of the collecting bag. In this way, a support member is provided which is able to keep the collecting bag open by keeping the walls of the collecting bag separated and thus reducing the risk of pancaking. Moreover, in this arrangement the support member is arranged and supported in an area between the base plate and the collecting bag. This prevents drag and pull from being formed in the collecting bag which may cause discomfort to the user or cause the upper part of the collecting bag to be pulled forward. This may cause closing of the bag or stop of the flow through the filter since, in many bag constructions, the filter is provided at the top part.

It should be understood that the walls of the collecting bag are not necessarily only formed of one material. They may be laminates of different material types or the walls may comprise different sheet materials placed next to each other but only attached to each other at the edges or at points by welds, adhesives or similar means. The distal wall can for example be formed by a laminated sheet which is liquid and odour tight for preventing output and odour therefrom from penetrating the wall, while a second sheet of a non woven material is placed next to the laminated sheet. The non woven sheet provides a comfortable feel against the skin and provides a moisture and vapour transporting material which keeps the skin dry. Thus, the second part of the support member can be engaged to any of the parts of the distal wall.

In one embodiment, the first part of the support member comprises coupling means and the support member further comprises a bridging element comprising at least a first and a second coupling area and wherein the coupling areas are separated by an intermediate section forming the second part of the support member.

In another embodiment of the ostomy appliance, the intermediate section extends along the distal surface of the distal wall of the collecting bag. Thus, it is easy to provide engagement means.

Many different types of engagement means can be incorporated.

For example, the engagement means can be provided as a sleeve on the distal wall forming a channel which is sized to receive at least part of the intermediate section of the bridging element.

In another embodiment, the engagement means are provided as cooperating velcro elements provided on the distal wall and the intermediate section.

Alternatively, the engagement means can be provided as an adhesive provided on either the distal wall, the intermediate section or both.

On many ostomy appliances known in the art, belt ears are provided for allowing the user to attach a belt to the base plate in order to provide added security from detachment. However, in many cases, these belt ears, which are often in the shape of looped rings, are not used. Thus, in one embodiment of the ostomy appliance, at least a first and a second coupling ear are provided on the distal side of the base plate and the first and the second coupling area of the bridging element are adapted for coupling with the first and second coupling ear, respectively. The looped rings may of course also be provided on the ostomy appliance for the purpose of supporting a support member according to the invention. This provides an easy coupling between the support member and the rest of the ostomy appliance by using features already provided on many common well-known ostomy base plates

As mentioned, the first and the second coupling ear may be in the shape of first and second looped rings, whereby the first and the second coupling areas may advantageously be in the form of first and second hooks having a size allowing them to couple with the looped rings.

In one embodiment, the support member further comprises at least one interposed element arranged between the base plate and the collecting bag, and the bridging element is adapted to be coupled to the interposed element at the respective first and second coupling areas.

The interposed element can in many regards be viewed as an adapter to allow the bridging element to be coupled to the ostomy appliance. Thus, the interposed element has means for coupling to the area between the base plate and the collecting bag and also has means for coupling to the bridging element.

Accordingly, in one embodiment of the ostomy appliance, the at least one interposed element is in the form of a flange element having an annular mounting opening with a diameter which is larger than the diameter of the through-going hole and the opening.

Thus, the flange element can be mounted around the coupling between the base plate and the collecting bag.

In another embodiment, the at least one interposed element is provided as two adapter elements each having a bridging coupling area for coupling with the respective first and second coupling area of the bridging element and a plate coupling area for coupling with the base plate.

It is often preferred by users to have as few pieces and parts for the ostomy appliance as possible. Thus, it is advantageous if the support member can be formed as one piece. Accordingly, in one embodiment, the first part of the support member comprises a flange element comprising an annular mounting opening with a diameter larger than the diameter of the through-going hole and the opening in the proximal wall and wherein the support member further comprises a bridging element extending from a first attachment area towards a coupling area, wherein the attachment area and the coupling area is separated by an intermediate section forming the second part of the support member.

In embodiments, the at least one interposed element comprises one or more removable elements making the diameter annular mounting opening therein size- adaptable. These elements may be in the form of one or more annular rings in the interposed element that may each be individually removable so as to provide the possibility of adapting the annular mounting opening in the interposed element according to the size of the through-going hole and the opening of the ostomy appliance of an individual user.

The annular rings may be essentially punched out in advance and/or may only be withheld in the interposed element by a small amount of material in one or more retention areas. Alternatively or additionally, the annular rings may have weakened annular lines between them so that they will be easily pressed out by the finger force of a user.

Thus, the removable elements make the diameter of the annular mounting opening in the interposed element size-adaptable according to individual needs.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 a, 1 b and 1 c show a first embodiment of a support member,

Fig. 2 shows a first embodiment of a support member arranged on an ostomy appliance.

Figs. 3 - 5 show a second embodiment of a support member,

Fig. 6 shows a third embodiment of a support member, and Fig. 7 shows a fourth embodiment of a support member.

DETAILED DESCRIPTION

A first embodiment of an ostomy appliance 1 according to the invention is shown in Fig. 2. Figures 1 a, 1 b and 1 c show, in greater detail, a support member 2 used in the first embodiment of the ostomy appliance 1 . The support member 2 is formed of a bridging element 3 and an interposed element in the form of a flange element 20.

The bridging element 3 is in the form of a strip 4 having first and second ends 5,6 separated by an intermediate section 7. The first and second ends are provided with first and second ribs 8,9 provided on the edge of the first end 5 and with third and fourth ribs 10, 1 1 provided on the edge of the second end 6.

The respective ribs are placed apart from each other along the edge, thereby creating a fork-like configuration at each end.

The flange element 20 is in the form of an annular ring 21 having a first through- going hole 22. On diametrically opposed side of the annular ring, a first and a second radially protruding gripping part 23, 24 are provided. The first and second gripping parts are formed of a first and second gripping flange 25, 26 that protrudes radially from the annular ring and is in the same plane as the annular ring. A respective first and second angled gripping flange 27, 28 extends from the first and the second gripping flange at an angle a1 , a2 between the surfaces of the respective gripping flanges and angled gripping flanges.

The angles are preferably below 90° so that the angled gripping flanges extend backwards towards the annular ring. The angle between the respective gripping flanges and angled gripping flanges provides respective first and second receiving grooves 29, 30.

The respective ribs of the edges of the bridging element are spaced apart with a distance that is greater than the length of the receiving grooves, corresponding to the width of the respective gripping flanges. Moreover, the length of the bridging element, from edge to edge, is longer than the distance between the first and the second receiving grooves 29, 30.

Thus, as shown in fig. 1 c, the support member is assembled by placing the edges of the bridge element in respective first and second receiving grooves, thereby forming respective coupling means. As at least the bridging element is flexible and/or resilient, it will bend due to the longer length and arch away from the plane of the annular ring of the flange element, wherein the coupling means are also arranged.

Fig. 2 shows how the support member is provided on an ostomy appliance in use. The flange element is placed between the ostomy bag 30 and the base plate 31 . The first through-going hole of the flange element has a size that allows it to fit around the connection between the base plate and the ostomy bag. A sleeve 32 is provided on the outer surface of the distal wall of the ostomy bag. The sleeve extends across the surface of the distal wall and has a size and orientation allowing the bridging element to be placed therein. The length between the receiving grooves is greater than the extent of the bag in the same direction. This allows for the coupling means to be established beyond the boundary of the ostomy pouch. Thus, as the bridging element bends, it will bend away from the base plate which is placed on the surface of the skin during use. During use, this results in the distal wall being spaced apart from the skin and thereby also the stoma, allowing the output from the stoma to fall into the ostomy pouch instead of being pressed against the distal wall.

A second embodiment of the support member 100 is shown in figures 3 - 5. The support member is in the form of a bridging element 101. The bridging element has an intermediate section 102, which separates two end sections 103, 104. The end sections are formed as two respective flaps 105, 106 which are bent backwards so that they travel back along the intermediate section. At the end of each flap, a hook shaped protrusion is provided.

The second embodiment of the support member 100 is suited for use with commonly known base plates 1 10 whereon diametrically opposed belt ears 1 1 1 , 1 12 are provided around the stoma receiving hole 1 13 of the base plate.

The hooks of the bridging element are sized and shaped so as to fit and couple with the belt ears. In this manner, the support member can be supported by the belt ears and thereby the base plate, without creating a pull on the ostomy pouch 120. A velcro strip 107 is provided on the proximal surface of the intermediate section of the bridging element. The velcro strip couples with the distal surface of the ostomy pouch and thus keeps the pouch open. In order to couple with the velcro strip, a corresponding strip is provided on the distal surface of the ostomy pouch. In some embodiments, the velcro strip on the intermediate section may couple with a non- woven cover sheet provided on the distal side of the ostomy pouch.

Fig. 6 shows a third embodiment of a one-piece support member 200 for use in an ostomy appliance according to the invention. The support member comprises a flange element in the form of an annular ring 201 defining a through-going hole 202. The hole has a size which allows the support member to be arranged around the connection between the urine bag and the base plate. A tab 203 extends radially out from the annular ring. Diametrically opposite the tab, a bridging element 204 also extends radially out from the annular ring. The bridging element has a length that is greater than the diameter of the annular ring 201 .

The support member 200 of the third embodiment is used very similar to that of the support member of the first embodiment. The annular ring is mounted around the ostomy appliance between the base plate and the urine bag and the bridging element is then bent backwards and the free end 205 of the bridging element is coupled to the tab 203. During or after this operation, the intermediate section 206 of the bridging element is engaged to the distal wall of the collecting bag. The coupling between the free end of the bridging element and the tab can be provided in different ways. It can, for example, be provided by an adhesive or a hook can be provided on one part and a corresponding hole, or several holes, can be provided on the opposite part. The hook can then couple with one of the holes in order to lock the support member.

In embodiments, and exemplified in Fig. 7, the coupling 307 between the free end 305 and the tab 303 of the support member 300 is adjustable by means of one or more protruding attachment means 308 attachable to corresponding means 309, shown in the drawing as receiving holes. The term adjustable should be understood at least so that the coupling may provide the possibility to position the free end 305 and the tab 303 in several different positions in relation to each other, e.g. facilitating that they can be set in relatively longer or shorter configurations effectively ensuring that a user may choose and/or adjust the distance of the intermediate section 306 of the second part of the support member 300 from the first part or annular ring 301 of the support member 300 depending on which hole(s) 309 attaches to which protruding attachment means 308.

In addition to the improved control and adjustability, the support member of the present invention effectively increases security against malfunction and/or any unintended collapse of the means for keeping the bag side walls apart and thus against pancaking.

Claims

1 . An ostomy appliance comprising a base plate having a proximal adhesive surface and a through-going hole extending in an axial direction through the base plate, the ostomy appliance further comprising a collecting bag arranged on the distal side of the base plate, the collecting bag comprising a proximal wall and a distal wall, where an opening is provided in the proximal wall for communication with the through-going hole, wherein

the ostomy appliance further comprises a support member, wherein a first part of the support member is arranged and supported between the base plate and the collecting bag and a second part of the support member which has a distance from the first part of the support member along the axial direction of the ostomy appliance and engagement means are provided for engaging the second part of the support member to the distal wall of the collecting bag.

2. An ostomy appliance according to claim 1 , wherein the first part of the support member comprises coupling means and wherein the support member further comprises a bridging element comprising at least a first and a second coupling area and wherein the coupling areas are separated by an intermediate section forming the second part of the support member.

3. An ostomy appliance according to claim 1 or 2, wherein the second part of the support member extends along the distal surface of the distal wall of the collecting bag.

4. An ostomy appliance according to claim 1 , 2 or 3, wherein the engagement means are provided as a sleeve on the distal wall forming a channel which is sized to receive at least part of the second part of the support member.

5. An ostomy appliance according to claim 1 , 2, 3 or 4, wherein the engagement means are provided as cooperating velcro elements provided on the distal wall and the second part of the support member.

6. An ostomy appliance according to claim 1 , 2, 3, 4 or 5, wherein the engagement means are provided as an adhesive provided on either the distal wall, the second part of the support member or both.

7. An ostomy appliance according to any one of the claims 2 - 6, wherein at least a first and a second coupling ear are provided on the distal side of the base plate, and wherein the first and the second coupling area of the bridging element are adapted for coupling with the first and the second coupling ear, respectively.

8. An ostomy appliance according to claim 7, wherein the first and the second coupling ear are in the shape of first and second looped rings, and the first and the second coupling areas are in the form of first and second hooks having a size allowing them to couple with the looped rings.

9. An ostomy appliance according to any one of the claims 2 - 6, wherein the support member further comprises at least one interposed element arranged between the base plate and the collecting bag, and wherein the bridging element is adapted to be coupled to the interposed element at the respective first and second coupling areas.

10. An ostomy appliance according to claim 9, wherein the at least one interposed element is in the form of a flange element having an annular mounting opening with a diameter which is larger than the diameter of the through-going hole and the opening in the proximal wall.

1 1 . An ostomy appliance according to claim 9, wherein the at least one interposed element is provided as two adapter elements each having a bridging coupling area for coupling with the respective first and second coupling area of the bridging element and a plate coupling area for coupling with the base plate.

12. An ostomy appliance according to any one of the claims 1 , 3, 4, 5 or 6, wherein the first part of the support member comprises a flange element comprising an annular mounting opening with a diameter larger than the diameter of the through- hole and the opening in the proximal wall and wherein the support member further comprises a bridging element extending from a first attachment area towards a coupling area, wherein the attachment area and the coupling area is separated by an intermediate section forming the second part of the support member.

13. An ostomy appliance according to claim 10, wherein the at least one interposed element comprises one or more removable elements.