GB2476081A

GB2476081A - A method of modifying or manufacturing a colostomy appliance

Info

Publication number: GB2476081A
Application number: GB0921645A
Authority: GB
Inventors: Neil Wiltshire; Peter Argent
Original assignee: Salts Healthcare Ltd
Current assignee: Salts Healthcare Ltd
Priority date: 2009-12-10
Filing date: 2009-12-10
Publication date: 2011-06-15
Anticipated expiration: 2029-12-10
Also published as: WO2011070373A1; GB0921645D0; EP2509545A1; GB2476081B

Abstract

A method of manufacturing a colostomy appliance 20 comprising a pouch for receipt of waste, a pouch flange 31 connected to the pouch, the flange including an opening to the interior of the pouch, a surface of the pouch flange in use faces a user and includes an adhesive surface 33 covered by a removable cover member 32. The method includes making an incision in the removable cover of the adhesive using a laser, said incision extending substantially around the opening and defining a portion which can be removed separately. The appliance includes a device 10 for surrounding a user's stoma having an opening to receive the stoma and a lip extending away from the opening to which the exposed adhesive surface is attached. The remaining cover can then be removed to allow the device to be secured around the stoma.

Description

Title: A Method of Modifying an Adhesive Member and a Method of Manufacturing an Ostomy Appliance

Description of Invention

This invention relates to a method of modifying an adhesive member. More particularly, but not exclusively, this invention relates to a method of modifying a body-side flange or pouch flange for an ostomy appliance, and to a method of manufacturing an ostomy appliance.

A stoma is a surgically constructed tube of a user's digestive tract that protrudes through a user's skin and allows for waste to be collected therefrom.

1 5 It is known to provide a user with an ostomy appliance including a pouch which has an opening to receive the stoma. A flange portion of the pouch is provided with an adhesive member (e.g. a hydrocolloid wafer, covered by a removable cover member) for adhering the pouch either directly to a user's skin surrounding the stoma (known as a one-piece appliance) or for adhering the pouch to a body-side flange, which itself is adhered to the user's skin around their stoma (known as a two-piece appliance). Each flange has an opening therethrough (for receipt of the stoma) which is, conventionally, created by a rotary die cutting process. The rotary die cuts through the hydrocolloid layer and the removable cover member (in that order) to create the opening.

In use, waste from the user's digestive tract is expelled through the stoma and is collected in the pouch. The user then either replaces the pouch or drains the collected waste from the pouch (if the pouch provides for such draining -usually by the provision of a resealable aperture at a lower part of the pouch).

One common problem with known ostomy pouches is that if a good seal around the stoma is not provided leaks can occur which can cause damage to the skin around the user's stoma. This can result in irritation and great discomfort to the user.

To address this problem, it is known to provide a device having an opening (to receive the stoma) surrounded by a peripheral wall, and a flange part connected to the peripheral wall, the flange part extending substantially perpendicularly (e.g. radially) away from the opening. The peripheral wall of the device is elastically deformable, so as to provide, in use, a fluid-tight seal between the peripheral wall and the user's stoma, thus preventing leakage etc.. The device is typically manufactured in a variety of sizes -e.g. a range of opening diameters -and the user can select the size which will match, as closely as possible, the external diameter of their stoma.

The device is typically manufactured using a moulding process, for example 1 5 injection moulding techniques which are well known in the art, and the material used is, typically, polyurethane (e.g. that known as AlphathaneTM), although any other suitable material could be utilised. Using injection moulding is beneficial, because the thickness (and thus the force required to stretch the opening) of the peripheral wall can be controlled to a tight tolerance. This is important, because a decreased elasticity could render the device harder for a user to position around their stoma and could possibly give rise to discomfort if the fit between the device and the stoma is too tight.

The device is positioned by the user over their stoma. The user then removes the removable cover member from the pouch flange or body-side flange (as the case may be for one-and two-piece appliances) and positions the pouch flange or body-side flange on top of the device. The user applies pressure so as to adhere the pouch flange or body-side flange to the device and to their skin. In the case of a two-piece appliance the user then adheres the pouch flange to the body-side flange.

One problem with this configuration is that it is time-consuming for the user to install, which is an issue if the user requires a number of installations per day.

In addition, due to the adhesive nature of the flanges, it can often be the case that the flange becomes adhered to a wall part of the device which can increase the difficulty of installation.

In an attempt to overcome this problem, it has been proposed to provide the device as an integral part of an ostomy appliance. To achieve this integration, it has been proposed to remove, at the manufacturing facility, the removable cover member covering the flange, adhere the device to the flange, so that the peripheral wall extends though the opening, and then re-apply the removable cover member to the exposed adhesive surface of the flange. Whilst this solves the problem of providing a "finished" product for the user, it is a very time-consuming process and often results in degradation to the adhesive surface of the flange. This is because it is virtually impossible to re-apply the removable cover member to the adhesive surface of the flange without trapping pockets of air therebetween. The regions of the adhesive surface adjacent these pockets of air dry out over time, and it is often the case that when the ostomy appliance reaches the user, the flange does not adhere properly to their skin (or to the body-side flange) -thus rendering the ostomy appliance useless.

According to a first aspect of the invention we provide a method of modifying an adhesive member, said adhesive member having an adhesive surface which is covered by a removable cover member, characterised in that the method includes the step of making an incision in the removable cover member using a laser, said incision defining a portion of the removable cover member which can be removed separately from the remainder of the removable cover member.

The laser may be directed onto a surface of the removable cover member and may make an incision only in the removable cover member.

The incision may originate at a periphery of the removable cover member.

The incision may extend inwardly towards a central region of the removable cover member.

The method may include the further step of removing a portion of the removable cover member so as to expose a portion of the adhesive surface thereof.

The adhesive member may be a body-side flange or pouch flange for an ostomy appliance, the flange including an opening for receiving a user's stoma.

A portion of the removable cover member adjacent the opening in the body-side flange or pouch flange may be removed.

The incision may extend inwardly towards the opening.

The incision may extend around the opening in the flange.

The incision around the opening may be substantially circular.

The removed portion of the removable cover member may be substantially annular.

According to a second aspect of the invention we provide a method of manufacturing an ostomy appliance, the ostomy appliance including:-a pouch for receipt of waste; a pouch flange connected to the pouch, the pouch flange having an opening communicating with an interior of the pouch, wherein a surface of the pouch flange which in use faces a user includes an adhesive for adhering the pouch flange to either a user's skin or a body-side flange, the adhesive surface being is covered by a removable cover member; and a device for surrounding a user's stoma, the device having an opening, surrounded by a peripheral wall, to receive the stoma, and a flange part connected to the peripheral wall, which flange part extends substantially perpendicularly away from the opening; 1 0 characterised in that the method includes the steps of:-making an incision in the removable cover member using a laser, said incision extending substantially around the opening and defining a portion of the removable cover member which can be removed separately from the remainder of the removable cover member; removing the portion of the removable cover member adjacent the opening in the pouch flange; and adhering the flange part of the device to the exposed adhesive surface of the pouch flange.

The incision may originate at a periphery of the removable cover member.

The incision may extend inwardly towards the opening, and then may extend around the opening.

The incision may extend radially inwardly towards the opening.

The incision around the opening maybe substantially circular.

The removed portion of the removable cover member may be substantially annular.

Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, of which:-Figure 1 is a side cross-sectional view of a device for surrounding a user's stoma; Figure 2 is a plan view of the device of figure 1; Figure 3 is a side cross-sectional view of an ostomy appliance in accordance with the second aspect of the invention; and Figure 4 is a plan view of a pouch flange with a removable cover member connected thereto.

It will be appreciated by the skilled person that the method in accordance with the present invention could be utilised in connection with any adhesive member which is covered by a removable cover member. The following example therefore illustrates one way of implementing the method of the present invention, and should not be viewed as limiting.

Referring to figures 1 and 2 these shown a device 10 for use with an ostomy appliance. The device 10 has an opening 12, surrounded by a substantially cylindrical peripheral wall 13 which in this example is less than or equal to 0.2mm in thickness. In use, and discussed in more detail below, the opening 12 receives a stoma (not shown). The device 10 also includes an annular flange part 14 which is connected to and extends substantially perpendicularly away from one end of the peripheral wall 13. The flange part 14 extends substantially radially away from an axis 1 6 of the opening.

The flange part 14 and the peripheral wall 13 are connected by a curved portion 15 which extends away from the axis 16 of the opening 12 as it extends from the peripheral wall 13 to the flange part 14. The curved portion between the peripheral wall 13 and the flange part 14 assists a user in centring the opening 1 2 over their stoma.

In this example, the peripheral wall 13 tapers towards the axis 16 of the opening 12 as it extends away from the flange part 14. This aids in providing an interference, fluid-tight, seal between the peripheral wall 13 and the user's stoma. As an example, the internal diameter of the opening 12 should be selected such that it is 3mm to 6mm smaller than the external diameter of the user's stoma, as this provides for an adequate interference, fluid-tight, seal. It has been found that the following dimensions are appropriate for use:-External Diameter of Internal Diameter of User's Stoma (mm) Opening 12 (mm) 17.0 to 20.0 14.00 20.0 to 23.0 17.00 23.0 to 26.0 20.00 26.0 to 29.0 23.00 29.0 to 32.0 26.00 32.0 to 35.0 29.00 35.0 to 38.0 32.00 38.0 to 41.0 35.00 In the present example, the taper is at an angle of 6°, but is must be appreciated that other angles of taper could be utilised. In addition, the tapering of the peripheral wall 13 provides for compact storage of one or more like devices 10, as they can be stacked one on top of each other, with the peripheral wall 13 of one device 10 received in the opening 12 of an adjacent device 10.

In the present example, the device 10 is manufactured as a one-piece component using a moulding process, for example injection moulding. It should be appreciated, however, that any other appropriate forming process can be used.

The device 10 is manufactured from a polyurethane material (e.g. that known as AlphathaneTM) and is, as a result, elastically deformable. This material property is essential for the device 1 0, as it ensures a fluid-tight fit with a user's stoma. It should be appreciate that other materials could be used so long as they provide for adequate elastic deformation of the opening 12.

Figure 4 shows a pouch flange 30 which has been modified using the method according to the first aspect of the invention. The flange 30 has an opening 38 for receiving a user's stoma and has an adhesive surface (provided by a hydrocolloid layer 31) which is covered by a removable cover member 32.

The opening 38 can be increased in size, depending on the size of the stoma which it is intended to receive.

An incision 35, 36 has been made in the removable cover member 32 using a laser. In more detail, the laser is directed onto the exterior surface of the removable cover member 32 to make the incision 35, 36. The laser originates the incision 35 at a periphery of the removable cover member 32 and from there the laser is moved radially inwardly towards the opening 38 such that the incision 35 also extends radially inwardly towards the opening 38. Once the laser reaches a predetermined distance from the opening 38 (slightly further away from the axis of the opening 38 than the radius of the flange part 14 of the device 10), the laser changes direction and moves in a circular path so as to make a circular incision 36 around the opening 38. The incisions 36 therefore defines an annular portion 32a of the removable cover member 32 which can be removed separately from the remainder of the removable cover member 32. It should be appreciated that two or more lasers could be used to make the incisions 35, 36.

Figure 3 shows cross-sectional view of an ostomy appliance 20 which has been manufactured in accordance with the second aspect of the invention.

The ostomy appliance 20 has a pouch 21, to receive waste, and a body-side flange 31 connected to the pouch 21. The flange 31 is identical to the flange 31 discussed above, albeit that the opening 38 has been increased in size.

The appliance 20 includes a device 10 (as described and shown in figures 1 and 2), the flange part 14 of which is adhered to an exposed adhesive surface 33 of the flange 31.

In more detail, in order to adhere the flange part 14 of the device 10 to the flange 31, the annular portion 32a of the removable cover member 32 is removed thus exposing an annular adhesive surface 33 of the flange 31. The peripheral wall 13 is then inserted through the opening 38 until the flange part 14 abuts the exposed annular adhesive surface 33 of the flange 31. Pressure is then applied at that interface to ensure that the parts adhere satisfactorily to each other. The appliance 20 is then ready for a user to install, and this is achieved in the normal way, as is well known in the art.

It must be appreciated that the flange 31 (whether or not connected to a pouch) may be provided with or without a device 10 connected thereto. In the latter case, the user can connect the device to the flange 31 in the way described above.

It should also be appreciated that the laser may be used to make an incision of any desired shape, and in any desired direction. For example, it is not necessary, although it may be advantageous) to originate the incision from the periphery of the removable cover member -the incision may originate in a central region of the removable cover member or elsewhere on the removable cover member.

In addition, it will also be understood that multiple incisions could be made in the removable cover member 32, e.g. concentric circular incisions, with it being left to the user to decide which annular ring(s) of removable cover member need to be removed for their size of device 10 (as defined by the diameter of their stoma). Furthermore, the incision need not be continuous -it may have interruptions along its length (e.g. perforated).

Finally, it should be appreciate that the method in accordance with the present invention could be utilised in connection with any adhesive member which is covered by a removable cover member. For example, the method could be used on the removable cover member of an adhesive wound dressing, an adhesive wound management device, an adhesive plaster or the like. In fact, the method can be used on any adhesive member which is covered by a removable cover member.

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.

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.

Claims

CLAIMS1. A method of modifying an adhesive member, said adhesive member having an adhesive surface which is covered by a removable cover member, characterised in that the method includes the step of making an incision in the removable cover member using a laser, said incision defining a portion of the removable cover member which can be removed separately from the remainder of the removable cover member.
2. A method according to claim 1 wherein the laser is directed onto a surface of the removable cover member and makes an incision only in the removable cover member.
3. A method according to any preceding claim wherein the incision originates at a periphery of the removable cover member.
4. A method according to claim 3 wherein the incision extends inwardly towards a central region of the removable cover member.
5. A method according to any preceding claim including the further step of removing a portion of the removable cover member so as to expose a portion of the adhesive surface thereof.
6. A method according to any preceding claim wherein the adhesive member is a body-side flange or pouch flange for an ostomy appliance, the flange including an opening for receiving a user's stoma.
7. A method according to claim 6 as appendent on claim 5 wherein a portion of the removable cover member adjacent the opening in the body-side flange or pouch flange is removed.
8. A method according to any one of claims 5 to 7 wherein the incision extends inwardly towards the opening in the flange.
9. A method according to any one of claims 5 to 8 wherein the incision extends around the opening in the flange.
10. A method according to claim 9 wherein the incision around the opening is substantially circular.
11. A method according to any preceding claim as appendant on claim 5, wherein the removed portion of the removable cover member is substantially annular.
12. A method of manufacturing an ostomy appliance, the ostomy appliance including:-a pouch for receipt of waste; a pouch flange connected to the pouch, the pouch flange having an opening communicating with an interior of the pouch, wherein a surface of the pouch flange which in use faces a user includes an adhesive for adhering the pouch flange to either a user's skin or a body-side flange, the adhesive surface being is covered by a removable cover member; and a device for surrounding a user's stoma, the device having an opening, surrounded by a peripheral wall, to receive the stoma, and a flange part connected to the peripheral wall, which flange part extends substantially perpendicularly away from the opening; characterised in that the method includes the steps of:-making an incision in the removable cover member using a laser, said incision extending substantially around the opening and defining a portion of the removable cover member which can be removed separately from the remainder of the removable cover member; removing the portion of the removable cover member adjacent the opening in the pouch flange; and adhering the flange part of the device to the exposed adhesive surface of the pouch flange.
13. A method according to claim 12 wherein the laser is directed onto a surface of the removable cover member and makes an incision only in the removable cover member.
14. A method according to claim 12 or claim 13 wherein the incision originates at a periphery of the removable cover member.
15. A method according to claim 14 wherein the incision extends inwardly towards the opening, and then extends around the opening.
16. A method according to claim 15 wherein the incision extends radially inwardly towards the opening.
17. A method according to any one of claims 12 to 16 wherein the incision around the opening is substantially circular.
18. A method according to any one of claims 12 to 17 wherein the removed portion of the removable cover member is substantially annular.
19. An adhesive member modified using the method of any one of claims 1 to 11.
20. A body-side flange or pouch flange for an ostomy appliance modified using the method of any one of claims 1 to 11.
21. An ostomy appliance having a body-side flange or pouch flange modified using the method of any one of claims 1 to 11.
22. An ostomy appliance manufactured using the method any one of claims 12to18.
23. An adhesive member as hereinbefore described with reference to and/or as shown in the accompanying drawings.
24. A body-side flange or pouch flange for an ostomy appliance substantially as hereinbefore described with reference to and/or as shown in the accompanying drawings.
25. An ostomy appliance substantially as hereinbefore described with reference to and/or as shown in the accompanying drawings.
26. Any novel feature or novel combination of features described herein with reference to and/or in the accompanying drawings.