WO2011070372A1

WO2011070372A1 - A method of modifying a component part of an ostomy appliance

Info

Publication number: WO2011070372A1
Application number: PCT/GB2010/052070
Authority: WO
Inventors: Neil Wiltshire; Peter Argent
Original assignee: Salts Healthcare Limited
Priority date: 2009-12-10
Filing date: 2010-12-10
Publication date: 2011-06-16
Also published as: GB2476080B; GB0921643D0; GB2476080A

Abstract

A method of modifying a component part of an ostomy appliance is described. The method includes the step of making an incision in the component part using a laser.

Description

Title: A Method of Modifying a Component Part of an Ostomy Appliance Description of Invention

This invention relates to a method of modifying a component part of an ostomy appliance. More particularly, but not exclusively, this invention relates to a method of modifying a device intended to surround a stoma of a user.

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. It is known to provide a user with an ostomy appliance including a pouch which has an opening to receive the stoma. A body-side portion of the pouch is provided with an adhesive member for adhering the pouch to a user's skin surrounding the stoma . 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 injection moulding techniques which are well known in the art, and the material used is, typically, polyurethane (e.g. that known as Alphathane™), 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. One issue, however, with these devices is their compatibility with length of a user's stoma. As is well known in the art, stomas come in a variety of lengths and it may often be the case that the length of the peripheral wall of the device is too long for a user's stoma. To address this, it has been proposed to manufacture the devices in a variety of lengths. However, the desired range of lengths, in combination with the variety of diameters required (as discussed above), would have given rise to substantial manufacturing costs, because a specific mould is required for each combination of opening diameter and wall length. Thus, the current situation is that the device is only manufactured in one length, but this has several disadvantages.

Users have been known to cut the peripheral wall of their device to length, rather crudely, e.g. using a pair of scissors, in order to match the length of the peripheral wall of the device with their stoma (either because they cannot purchase a device with a peripheral wall which is short enough, or because a device with the correct wall length is not available). As will be appreciated, this crude modification results in an uneven finish at the end of the device, and can give rise to distortion to the peripheral wall (because the wall deforms as it is being cut, so it is difficult to cut in a straight line), thus reducing the effectiveness of the fluid-tight seal. Furthermore, some users will need to change the device regularly throughout the day, and will therefore have to cut numerous devices, which will take up a significant proportion of their time.

In addition, it is not easily possible to judge the length of peripheral wall which needs to be removed without first placing the device over the stoma. User's may attempt to cut the wall to length when the device is in situ, which is dangerous and can result in injury to the user, particularly if they have poor sight.

According to the present invention, we provide a method of modifying a component part of an ostomy appliance, the method including the step of making an incision in the component part using a laser.

Utilising a laser in this way means that, for example, a device for surrounding a user's stoma can be cut to a user's desired length, before it is purchased by them. This means that the device can be manufactured (e.g. injection moulded) with only one length of peripheral wall, which can then be cut to length as desired. This reduces, considerably, manufacturing costs and renders the device more easy to use by the end user.

The incision may result in the removal of a portion of the component part.

The incision may result in the shortening of a portion of the component part.

The method may include the step of making a continuous, e.g. circumferential, incision in the component part. The component part may be a device for surrounding a stoma, the device including an opening, to receive the stoma, surrounded by a peripheral wall, and the method including the step of making an incision in the peripheral wall of the device.

The method includes the step of making an incision in the peripheral wall so as to remove a portion of the wall, thus reducing its length.

The incision may be continuous and may extend circumferentially around the peripheral wall.

The laser used may be a CO2 laser, or alternatively any laser which is capable of cutting the material. For example, gas, solid state, dye, diode, green light and excimer lasers could be used.

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 use with an ostomy appliance; and

Figure 2 is a plan view of the device of figure 1 .

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 1 3 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 1 3. The flange part 14 extends substantially radially away from an axis 16 of the opening. The flange part 14 and the peripheral wall 1 3 are connected by a curved portion 1 5 which extends away from the axis 1 6 of the opening 12 as it extends from the peripheral wall 13 to the flange part 14. The curved portion 15 between the peripheral wall 13 and the flange part 14 assists a user in centring the opening 12 over their stoma.

In this example, the peripheral wall 1 3 tapers towards the axis 1 6 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:-

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 Alphathane™) and is, as a result, elastically deformable. This material property is essential for the device 10, 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.

As shown in figure 1 , the device 10 is manufactured with a relatively long peripheral wall 13, which ends at an end face 36. This length of peripheral wall 13 would be required by a user having a long stoma. However, if the peripheral wall 13 up to the end face 36 is too long for the user, its length can be reduced using the method of the present invention. This is achieved by making an incision in the peripheral wall 13 along, for example, one of the circumferentially extending lines 31 , 32, 33, 34 or 35 using a laser (or any desired axial position along the peripheral wall 13). The incision is, preferably, a continuous incision and results in the removal of a length of the peripheral wall 13, thus shortening the peripheral wall 13, to the desired length.

The incision can be made in a number of ways - all that is required is to effect some form of relative movement between the device and the laser.

In one, preferred, method the device 10 may be supported on a rotatable mandrel which then effects rotation of the device 10 relative to a stationary laser angled so as to direct its beam radially onto the surface of the rotating device 10. Thus, the laser makes the incision around the peripheral wall 13 as the device 10 is rotated by the mandrel. In an alternative method, the device 10 may be supported by a mandrel, but the mandrel may not rotate and instead the laser may be caused to rotate around the device 10 so as to make the incision therein, again with the laser angled so as to direct its beam radially onto the surface of the rotating device 10.

In a further alternative, the device 10 may be supported and then moved unidirectionally through a stationary laser. Thus, the laser may make the incision laterally through the wall 13 like a knife cutting axially through a carrot.

In yet a further alternative, the device 10 may be supported in a fixed position, with the laser being moved unidirectionally (e.g. laterally) through the device 10, so as to make the incision. Again, the laser would make an incision through the wall 13 like a knife cutting axially through carrot.

It is also possible to make an angled incision (see for example dashed line 37 in figure 1 ) in the peripheral wall 13, as this may match more closely the shape of the device 10 to the shape of the user's stoma. In fact, it is possible to make an incision of any desired shape, and in any desired direction. For example, the laser could make (when viewed laterally as shown in figure 1 ) V-shaped, convex or concave incisions, or indeed any shape to conform to the shape of a user's stoma. Examples of these shapes are shown in figure 1 in dotted lines 38, 39 and 40. The laser used to make the incision in the device 10 is a CO2 laser, which is well known in the art of lasers. It should be appreciated, however, that any suitable laser could be utilised so long as it is capable of making an incision in the device 10, whatever material the device 10 is manufactured from. In addition, it should be understood that the incision need not be continuous - it may have interruptions along its length (e.g. perforated). Furthermore, it will also be understood that multiple incisions (e.g. multiple rings of perforations) could be made in the peripheral wall 13, with it being left to the user to decide which perforation applies for their length of stoma. The perforations can be made small enough such that they do not permit easily the passage of fluid.

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

1 . A method of modifying a component part of an ostomy appliance, the method including the step of making an incision in the component part using a laser.

2. A method according to claim 1 wherein the incision results in the removal of a portion of the component part.

3. A method according to claim 1 wherein the incision results in the shortening of a portion of the component part.

4. A method according to any preceding claim including the step of making a continuous incision in the component part.

5. A method according to any preceding claim wherein the component part is a device for surrounding a stoma, the device including an opening, to receive the stoma, surrounded by a peripheral wall, and the method including the step of making an incision in the peripheral wall of the device.

6. A method according to claim 5 wherein the method includes the step of making an incision in the peripheral wall so as to remove a portion of the wall, thus reducing its length.

7. A method according to claim 5 or claim 6 wherein the incision is continuous and extends circumferentially around the peripheral wall.

8. A method according to any preceding claim wherein the laser used is a CO2 laser.

9. A component part of an ostomy appliance modified using the method of any one of claims 1 to 8.

10. A device for surrounding a stoma modified using the method of any one of claims 1 to 9.

1 1 . An ostomy appliance having a component part modified using the method of any one of claims 1 to 8.

12. A component part of an ostomy appliance substantially as hereinbefore described with reference to and/or as shown in the accompanying drawings.

13. A device for surround ing a stoma su bstantially as herein before described with reference to and/or as shown in the accompanying drawings.

14. Any novel feature or novel combination of features described herein with reference to and/or in the accompanying drawings.