Field of the Invention

The present invention is directed to a stoma bag and, especially, to an easy release stoma bag flange.

Background of the Invention

A colostomy is a surgical procedure in which a patient's colon is provided with an artificial opening, referred to as a stoma, through which the colon may be artificially evacuated. A disposable colostomy bag is coupled with the stoma for the collection of human waste. The bag is typically constructed with plastics material, rubber or a similar liquid impermeable material and has an opening thereon for receiving the stoma. Once the bag is full, it is usually detached from the stoma, discarded, and replaced. Existing stoma bags are attached to the body using an adhesive flange plate. Upon changing these stoma bags, an adhesive remover in spray form is used to dissolve the adhesive layer between the stoma bag flange plate and the wearer’s skin. The flange is then gently prized from the body.

However, the existing stoma bags require the application of adhesive remover spray repeatedly to the outer rim of the stoma bag flange plate which creates slow and sometimes uncomfortable removal. This process is also time-consuming and requires excessive amounts of adhesive remover spray than is required which may be costly.

It is an aim of the present invention to provide a stoma bag with a system that provides an easy release of the stoma bag for repeated, even daily, use.

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SUBSTITUTE SHEET (RULE 26) Statements of the Invention

Accordingly, a first aspect of the present invention is directed to a stoma bag comprising:

- a pouch for collecting human waste; and

- a flange plate coated with an adhesive layer configured to attach the pouch to the abdomen of a human body having a spiral pathway in the adhesive layer; wherein, the spiral pathway comprises a first end point to receive an adhesive remover fluid and a second end point at its extremity to release pressure or excess adhesive remover.

In a preferred embodiment of the invention said fluid may be a liquid or a gas.

In a preferred embodiment of the invention the gas may be air or a gas that corresponds with the nature of the adhesive whereby, the air lifts the flange away from the skin to facilitate removal of the dressing, or the gas degrades the adhesive and also, ideally, works to lift the flange away from the skin to facilitate removal of the dressing. Alternatively, the adhesive remover may be a liquid which degrades the adhesive and also, ideally, works to lift the flange away from the skin to facilitate removal of the dressing.

Advantageously, the spiral pathway is a spiral groove in the flange plate or more particularly the adhesive of the flange plate. This provides the advantage to better guide the adhesive removal solution into the centre of or across the flange plate. Preferably, the stoma bag further comprises attachment means at the first end point. Advantageously, the attachment means are a connector adapted to receive an adhesive remover fluid, gas or solution, such as a spray.

This system provides the advantage that an adhesive remover fluid, gas or solution, can be directly injected into the heart of the flange plate through the opening thus creating a more effective removal of the stoma bag.

This penetrative system will enable the use of less adhesive removal fluid and will ease the work for a carer to remove the stoma bag from a sick or injured patient for example children. This will also reduce the chances of damaging the skin upon removal of the stoma bag.

This system will also enable the use of stronger medical adhesives on stoma bag flanges thus creating a stronger seal between the stoma flange and the skin, resulting in less chance of leakage of human waste from the flange. This is a very important consideration for users of stoma bags.

In any preferred aspect or embodiment of the invention said spiral pathway may, advantageously, also include tributaries or capillaries i.e. , small off-shoots that enable the adhesive remover to penetrate a greater surface area of the flange to further facilitate removal of the flange from the epidermis. Most ideally, the tributaries or capillaries are concentrated near to the pouch and so in the area where the skin is most fragile. In a preferred embodiment of the invention the flanges are preferably made from hydrocolloids or breathable silicon.

Most suitably the adhesive remover used is an organosilicon compound, such as hexamethyldisiloxane.

Those skilled in the art will appreciate that the invention is concerned with the safe removal of a stoma bag by ensuring an adhesive remover penetrates a layer of adhesive to either breakdown the adhesive thus gently ensuring it can be easily lifted from the skin or to provide a force to lift it evenly and with equally applied pressure from the skin.

In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise”, or variations such as “comprises” or “comprising” is used in an inclusive sense i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

All references, including any patent or patent application, cited in this specification are hereby incorporated by reference. No admission is made that any reference constitutes prior art. Further, no admission is made that any of the prior art constitutes part of the common general knowledge in the art. Preferred features of each aspect of the invention may be as described in connection with any of the other aspects.

Other features of the present invention will become apparent from the following examples. Generally speaking, the invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including the accompanying claims and drawings). Thus, features, integers, characteristics, compounds or chemical moieties described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein, unless incompatible therewith.

Moreover, unless stated otherwise, any feature disclosed herein may be replaced by an alternative feature serving the same or a similar purpose.

Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

An example of a stoma bag according to the present invention will now be described hereinbelow with reference to the accompanying drawings, in which:

Figure 1 is a top view of a stoma bag according to the present invention; and Figure 2 is a top view of a stoma flange plate according to a first embodiment of the present invention.

Figure 3A is a cross-sectional view of a flange plate according to a first embodiment the present invention.

Figure 3B is a cross-sectional view of a flange plate according to a second embodiment the present invention.

Figure 1 shows a stoma bag 10 having a top part 1 and a bottom part 2 forming a pouch 12 of a pear shape in this example. The top part 1 has an opening dimensioned and configured to receive the stoma via a flange plate 14 surrounding a stoma hole 16.

Figure 2 shows a flange plate 14 having a spiral groove 18 of around 2mm-4mm diameter set into the flange plate 14 starting at the outer edge 20 and working its way into the centre 22 of the flange plate 14. The spiral groove 18 does not bear adhesive and will act as a pathway for the adhesive remover liquid to reach the adhered areas. Small side grooves 26 branch from the spiral groove 18. The number and the direction of these are adjusted as required, see below. In this example, six small side grooves 26 are shown.

An entry point 23 is located on the outer edge 20 of the flange plate 14 to the spiral groove 18 for attachment of a nozzle of the adhesive spray dispenser. The adhesive remover solution will then move through to the centre 22 of the flange plate 14 via pressure and capillary action. At the end of the spiral 18 a release hole 24 is located to stop the back pressure. The stoma bag 10 is secured to the user’s body like any other stoma bags using a flange plate 14 bearing adhesive.

Figure 3A shows the cross-section of a flange plate 14 having a spiral groove 18 through the adhesive layer 19 acting as a pathway in this instance. The spiral groove 18 bears no adhesive while the other areas outside the spiral groove 18 bears adhesive. The adhesive remover solution will penetrate throughout the spiral groove 18 of the flange plate 14 with one short burst where it is most needed. The flange plate can then be removed with ease.

Figure 3B shows the cross-section of a flange plate 14 having a single track 17 through the adhesive layer 19 acting as a pathway in this instance. The single track 17 bears no adhesive while the other areas outside the single track 17 bears adhesive. The adhesive remover solution will penetrate throughout the single track 17 of the flange plate 14 with one short burst where it is most needed. The flange plate can then be removed with ease.

This system provides a simplified method to attach the nozzle of an adhesive remover spray to the entry point 23 on the flange plate 14. The entry point 23 can be a hole, an extension of the spiral groove 18 or a separated connector adapted to receive an adhesive remover spray.

Optionally, but ideally, channel 18 is provided with a number of off-shoots or side grooves 26 that branch from spiral grove 18. The size of these off- shoots or side grooves can be small to provide a ‘capillary bed’ of interconnected channels that enable adhesive remover to permeate the entire flange, or a large part of the flange, thus optimising removal of same because the adhesive is broken down or lifted substantially across its skin contact area thus facilitating its removal from the skin.

In certain embodiments the number of off-shoots or side grooves 26 are concentrated near the opening where the pouch is situated thus ensuring removal of the stoma bag is facilitated at the part of the skin which is most fragile.