GB2408211A

GB2408211A - Ostomy bag with multiple releasable attachment means

Info

Publication number: GB2408211A
Application number: GB0425528A
Authority: GB
Inventors: Charles Gaffney
Original assignee: Edward Gaffney
Current assignee: Edward Gaffney
Priority date: 2003-11-19
Filing date: 2004-11-19
Publication date: 2005-05-25
Anticipated expiration: 2024-11-19
Also published as: GB2408211B; GB0425528D0

Abstract

An improved ostomy bag for use by a subject following a surgical procedure during which the stoma is formed. The bag comprises a sealed waterproof pouch having a wall proximal to the body in use and a wall distal from the body in use. The pouch has a lower edge 3 and an upper edge 4 and the proximal wall 11 has an aperture 5 spaced from the upper edge of the pouch to be in registry with a stoma in use. An adhesive ring 14 is disposed around the aperture 5 to act as primary attachment means. The pouch further comprises a releasable attachment means 7 disposed above and separate from the aperture in use for releasably fastening the pouch onto the body of the subject above the stoma.

Description

240821 1

AN IMPROVED BAG FOR USE BY A SUBJECT FOLLOWING

A SURGICAL PROCEDURE DURING WHICH A STOMA IS FORMED

The present invention relates to an improved bag for use by a subject following a colostomy, ileostomy or similar surgical procedure.

Digestive problems and in particular bowel problems result in large numbers of people receiving surgery each year where the outcome of the surgery requires the patient to wear a colostomy bag. The term colostomy bag is used throughout the remainder of the 0 specification but it will be understood to mean any bag suitable for use by a subject following any one of a number of surgical procedures including a colostomy and an ileostomy.

At present, most conventional colostomy bags comprise a flexible waterproof sheet material formed as a pair of walls disposed face to face and permanently secured together along their peripheries to define the bag. One of the bag's walls has an aperture adjacent to but spaced apart from the upper edge of the bag and the aperture is adapted to receive a stoma. Localised attachment means in the form of an adhesive annular stiffening ring is provided around the aperture for attaching the bag to the body wall of the patient. :- 'e.

In the days following a surgical procedure such as a bowel operation, the patient

. to receives bowel irrigation a number of times a day which necessitates frequent bag changes : ' : leaving the skin around the stoma irritated, inflamed and very painful. The skin gradually ^ heals when the irrigation treatment is completed and the bag then only needs daily replacement. However, there are still many problems associated with conventional colostomy bags due to the weight of the bag when filling which puts stress on the skin area surrounding the stoma. This results in frequent leakage and generates a high infection risk due to the damaged skin coming into contact with the leaked material. A number of adhesives have been developed in order to obviate or mitigate these problems such as the Eakin_ cohesive and these cohesive materials provide some relief without directly addressing the core problems associated with conventional colostomy bags...DTD: Additionally, when the conventional colostomy bag part fills, the upper portion of the bag is pulled out and down from the body wall of the patient putting further pressure on the skin surrounding the stoma where the bag is attached. As the bag continues to fill, further distortion of the bag causes the wall of the bag distal from the patient's body wall to be l o pulled down around the aperture of the bag and to block the passage of waste thereby preventing further waste from dropping down into the bag and further exacerbating the problem. In this configuration, the top of the bag projects out from the abdomen and is liable to catch on objects close to the body of the patient. Finally, in this configuration, the contents of the bag are visible through the transparent material which is an undesirable situation for couples wishing to become intimate, for example.

It is an object of the present invention to obviate or mitigate the problems of leakage, drooping, waste blockage and waste visibility associated with conventional colostomy bags.

Accordingly, the present invention provides an improved bag for use by a subject e following a surgical procedure during which a stoma is formed, the bag comprising a sealed ë waterproof pouch having a wall proximal to the body in use and a wall distal from the body in use, the pouch having a lower edge and an upper edge and the proximal wall having an ..

( . aperture spaced from the upper edge of the pouch to be in registry with a stoma in use, wherein the pouch further comprises a releasable attachment means disposed above and separate from the aperture in use for releasably fastening the pouch onto the body of the subject above the stoma.

Preferably, the releasable attachment means is disposed adjacent at least a portion of the upper edge of the pouch.

Advantageously, the provision of an attachment means adjacent at least a portion of the upper edge of the pouch, above and separate from the aperture in use has a number of technical advantages. The weight of the bag and it's contents is now concentrated on the abdomen region where muscle and skin are much stronger than the muscle and tissue around the stoma. As almost none of the weight of the bag is supported around the stoma region, lo this results in a lot less irritation of the skin in this area due in part to the reduction of friction. Another valuable technical advantage with the location of the attachment means adjacent the upper edge is that the wall of the pouch distal from the body of a person in use is held taut between the lower edge and the upper edge of the pouch. This prevents the previously inherent bunching up of the walls of the pouch around the aperture which is in registry with the waste delivering stoma in use. This is a major technical advance over conventional colostomy bags. :e ..e ...

Furthermore, as the weight of the bag and its contents is no longer concentrated : around the area of the stoma there is a much reduced occurrence of leaks which reduces the : incidence of infection or irritation of skin surrounding the stoma. Finally, the waste material 2b is no longer visible as the top edge of the pouch is attached to the abdomen of the patient. . .

. .: The improved bag has enhanced overall security and safety which increases the confidence levels of the person wearing the device.

Advantageously, a person wearing this bag with an improved aesthetic appearance has greater confidence, security, safety and comfort. In use, the bag is now flatter and more streamlined reducing friction with clothing. Furthermore, when a person wearing the bag is engaged in exercise, there is no longer a need to wear a tight restrictive girdle associated s with bags of the prior art, which girdle also had the negative effect of blocking the flow of discharge from the stoma.

Ideally, the releasable attachment means is extending along the upper edge of the pouch.

Preferably, the releasable attachment means is attached to the distal wall of the pouch lo along the upper edge thereof and has a flap protruding above the upper edge of the pouch.

Ideally, the flap has a surface proximal to the person's body in use and at least a portion of the proximal surface of the flap has adhesive disposed thereon for adhering the flap to the abdominal region of the person.

Preferably, the entire proximal surface of the flap is covered with the adhesive.

Ideally, the releasable attachment means extends over the entire surface of the distal - .e wall of the pouch. Beneficially, the tensile force caused by the weight of the bag and the waste material in the bag is transmitted through the attachment means expanding over the distal wall of the pouch which is held taut and as a result avoiding sagging/clumping of the . distal wall around the stoma. As a result, the discharge from the stoma finds its way directly ë it to the bottom of the bag.

Advantageously, leaks can now be reduced and ideally controlled to be dry odour leaks. Previously, when a leak occurred, the only weight bearing adhesive was attached to the often delicate, raw peristomal skin. As a result of the load on the leak cavity, the leak progressed rapidly around the adhesive flange, resulting in an unavoidable total failure of the bag attachment. A dry vertical odour leak can now be easily controlled by retiring discretely for a brief period and effecting a simple repair with a couple of strips of micro pore tape for example, which can be easily kept conveniently at hand. Panic, concern, worry and confusion can be avoided and a person's confidence and peace of mind is improved. The person wearing the bag is no longer a slave to the bag.

Preferably, the releasable attachment means is a flexible strip having one surface attached to the proximal wall of the pouch along the upper edge thereof and at least a portion lo of the exposed surface of the strip has an adhesive disposed thereon.

The adhesive releasably fastens the pouch to the abdominal region of the patient away from the stoma.

Ideally, the adhesive is protected by a releasable cover prior to use by a patient.

As with conventional colostomy bags, a stiffening annular ring is disposed around the aperture of the improved colostomy bag, the ring having a portion of adhesive and a :e portion of antiseptic material carried thereon. .. I.

Ideally, a reduced volume of adhesive is carried on the annular ring of the improved ë bag compared to standard bags. This is due to the fact that a substantial volume of adhesive is disposed on the attachment member. . .

do Preferably, the adhesive on the annular stiffening ring provides a waterproof seal between the ring and body preventing the bag and body from separating and generating leaks. The stiffening ring is not required to carry any of the weight of the bag and its contents.

Ideally, the colostomy bag has a resealable discharge opening at the lower edge of the pouch. This allows the bag to be emptied intermittently.

Ideally, the upper half of the annular stiffening ring in use has a weakened adhesive force compared to the lower half of the annular stiffening ring. As most leaks/bag failures occur as a result of the bag being squeezed in a ballooned state, if the adhesive force acting between the upper half of the annular stiffening ring and a person's body is less than the adhesive force acting between the lower half of the annular stiffening ring and the person's lo body, then it is more likely the leak will occur on the upper half of the seal between ring and body. This area of the adhesive annular ring is referred to as nine o'clock to three o'clock.

Preferably, there is a reduced volume of adhesive applied on the upper half of the annular stiffening ring.

Alternatively, an adhesive with a reduced adhesive force is applied to the upper half ofthe annular stiffening ring. :e .

. In another embodiment of annular stiffening ring, the surface area of the upper .

portion of the annular stiffening ring is reduced. .e : -e

Preferably, the colostomy bag is manufactured in a range of colours. : ë..

Ideally, the colostomy bag has designs such as flags, emblems or logos disposed ë thereon.

Preferably, the colostomy bag may have a covering of lace, frills, or ribbons. This could help people wearing bags of this type to at least partially overcome confidence issues when meeting partners and/or becoming intimate.

The invention will now be described with reference to the accompanying drawings, s which show by way of example only three embodiments of colostomy bag in accordance with the invention. In the drawings: Figure 1 is a front elevational view of a first embodiment of an improved colostomy bag; Figure 2 is a front elevational view of a second embodiment of an improved lo colostomy bag; and Figure 3 is a front elevational view of a third embodiment of an improved colostomy bag.

In the drawings there is shown a colostomy bag indicated generally by the reference numeral 1. The colostomy bag 1 has a waterproof sealed pouch 2 having a wall 11 proximal to the body in use and a wall (not shown) distal from the body in use. The pouch has a lower ë edge 3 and an upper edge 4 when mounted on a person's body in use. Proximal wall 11 of the bag 1 has an aperture 5 defined therein, the aperture 5 being spaced apart from the upper edge 4. The aperture 5 is in register with a stoma (not shown) in use. An annular ring 14 is disposed on the proximal wall 11 around the aperture 5 and the ring 14 has a portion of ë t adhesive and a portion of antiseptic material disposed thereon. There is a full ring of adhesive to provide the waterproof seal.

Attachment members 7, 17 are disposed on the proximal walls 11 of the bags 1 of Figure 1 and Figure 2 respectively and extend along the upper edge 4 of the respective pouches 2. It will of course be appreciated that the shape ofthe attachment members 7,17 is not limited to the two embodiments shown as it will be apparent to one of ordinary skill in s the art that many shapes and sizes of attachment member will provide the same function and the attachment member may include such arrangements as a plurality of strips or patches.

The attachment members 7, 17 comprise a strip 21 of flexible material having one surface attached to the proximal wall 11 and one exposed surface 22 having an adhesive carried thereon. The upper edge 4 of the pouch 2 of Fig. 1 is flat whereas the upper edge 4 lo of the pouch 2 of Fig. 2 is arcuate and the shape of the upper edge of the strips of both attachment members 7, 17 correspond to the shape of the upper edges 4 of the respective pouches 2. The strips 21 and the annular rings 14 can have releasable purl-off masking (not shown) located thereon prior to applying the bag 1 to the body in order to protect the adhesive. All of the bags 1 have a resealable discharge opening 25 located along their lower Is edge 3.

In use, a person peels the cover off the annular ring 14 and applies the annular ring . .. 14 onto the skin around the stoma. The person then removes the cover from the strip 21 and .- adheres the exposed surface 22 of the strip to their abdomen region. The adhesive on the e.e strip takes the weight of the bag and its contents which means the adhesive on the annular ring 14 has little or no load bearing requirement and is only required to seal the ring 14 to the - .e . : skin around the stoma. ë

Referring now to Fig. 3, attachment member 31 is attached to the wall of the bag 1 distal from a person's body in use. The attachment member 31 may be adhered to a portion of the distal wall adjacent at least a portion of the upper edge 4. Alternatively, the attachment member 31is adhered over the entire surface of the distal wall of the bag 1. The attachment member 31 has a flap 35 protruding beyond the upper edge 4 of the bag 1. The surface 26 of the flap 35 proximal to a person's body in use carries an adhesive for adhering the flap 35to s the person's body above the stoma. The annular stiffening ring 14 is divided into an upper half 37 and a lower half 38. The adhesive force acting between the upper half 37 of the ring 14 and the person's body is less than the adhesive force acting between the lower half 38 of the ring 14 and the person's body to encourage unavoidable leaks to occur between the upper half 37 of the ring 14 and the person's body. It will of course be appreciated that the lo weakened adhesive force may be applied to a more limited range of the annular stiffening ring 14 than the area from nine o'clock around to three o'clock. This feature of the invention would work equally as well with the weakened adhesive force acting between the surface area of the ring 14 defined from ten o'clock around to two o'clock. Broken line 39 is provided on the upper half 37 of the annular stiffening ring 4 to show a person the line to cut along to reduce the surface area of the upper half 37 of the ring 14 in order to reduce the adhesive force between the upper half 37 and the person's body particularly if the adhesive force of the adhesive on the upper and lower halves is the same. . ëc.

- -- Variations and modifications can be made without departing from the scope of the -..

invention defined in the appended claims. -ec . ë- . c .

Claims

1. An improved bag for use by a subject following a surgical procedure during which a stoma is formed, the bag comprising a sealed waterproof pouch having a wall proximal to the body in use and a wall distal from the body in use, the pouch having a lower edge and an upper edge and the proximal wall having an aperture spaced from the upper edge of the pouch to be in registry with a stoma in use, wherein the pouch furler comprises a releasable attachment means disposed above and separate from the aperture in use for releasably fastening the pouch onto the body of the lo subject above the stoma.

2. An improved bag as claimed in claim 1, wherein the releasable attachment means is disposed adjacent at least a portion of the upper edge of the pouch.

3. An improved bag as claimed in claim 1 or claim 2, wherein the releasable attachment means extends along the upper edge of the pouch.

4. An improved bag as claimed in any one of the preceding claims, wherein the releasable attachment means is attached to the distal wall of the pouch along the A. upper edge thereof and has a flap protruding above the upper edge of the pouch.

5. An improved bag as claimed in claim 4, wherein the flap has a surface proximal to the subject's body in use and at least a portion of the proximal surface of the flap has ; adhesive disposed thereon for adhering the flap to the abdominal region of the .

person.

6. An improved bag as claimed in claim 5, wherein the entire proximal surface of the flap is covered with adhesive.

7. An improved bag as claimed in any one of the preceding claims, wherein the releasable attachment means extends over the entire surface of the distal wall of the pouch.

8. An improved bag as claimed in any one of the preceding claims, wherein the releasable attachment means is a flexible strip having one surface attached to the proximal wall of the pouch along the upper edge thereof and at least a portion of the exposed surface of the strip has an adhesive disposed thereon.

lo 9. An improved bag as claimed in any one of the preceding claims, wherein a stiffening annular ring is disposed around the aperture of the improved bag, the ring having a portion of adhesive and a portion of antiseptic material carried thereon.

10. An improved bag as claimed in claim 9, wherein the upper portion ofthe annular stiffening ring in use has a weakened adhesive force compared to the lower portion of the annular stiffening ring. .

11. An improved bag substantially as hereinbefore described with reference to and as shown in the accompanying drawings. He A. ..CLME: Amendments to the claims have been filed as follows l? 1. An improved bag for use by a subject following a surgical procedure during which a stoma is formed, the bag comprising a sealed waterproof pouch having a wall proximal to the body in use and a wall distal from the body in use, the pouch having a lower edge and an upper edge and the proximal wall having an aperture spaced from the upper edge of the pouch to be in registry with a stoma in use, the pouch further comprising a releasable attachment means disposed above and separate from the aperture in use for releasably fastening the pouch onto the body of the subject lo above the stoma, wherein the releasable attachment means is attached to the distal wall of the pouch.

3. An improved bag as claimed in claim 1 or claim 2, wherein the releasable attachment means extends along the upper edge of the pouch and has a flap protruding above the upper edge of the pouch.

4. An improved bag as claimed in claim 3, wherein the flap has a surface proximal to the subject's body in use and at least a portion of the proximal surface of the flap has adhesive disposed thereon for adhering the flap to the abdominal region of the person. 1&

5. An improved bag as claimed in claim 4, wherein the entire proximal surface of the flap is covered with adhesive.

6. AT] improved bag as claimed in any one of the preceding claims, wherein the releasable attachment means extends over the entire surface of the distal wall of the pouch.

7. An improved bag as claimed in any one of the preceding claims, wherein a stiffening annular ring is disposed around the aperture of the improved bag, the ring having a portion of adhesive and a portion of antiseptic material carried thereon.

0 8. An improved bag as claimed in claim 7, wherein the upper portion of the annular stiffening ring in use has a weakened adhesive force compared to the lower portion of the annular stiffening ring.

9. An improved bag substantially as hereinbefore described with reference to and as shown in Fig. 3 of the accompanying drawings