OSTOMY APPLIANCES

A pouch having a vent aperture and a filter secured to the pouch with adhesive and covering the vent aperture. The filter includes an adhesive layer comprising the adhesive and an adsorbent layer on the adhesive layer. The filter also includes a gas permeable cover layer secured to the adhesive layer such that the adsorbent layer is covered by the gas permeable cover layer. The gas permeable cover layer has an outer profile and the adhesive layer has a corresponding outer profile which is in register with the outer profile of the gas permeable cover layer. The adsorbent layer is positioned on a first side of the adhesive layer so that a first portion of the first side of the adhesive layer is not covered by the adsorbent layer and the gas permeable cover layer is secured to the first portion of the first side of the adhesive layer.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to an ostomy appliance and a method of manufacturing such an appliance. The invention also relates to a filter for an ostomy appliance.

BACKGROUND TO THE INVENTION

An ostomy is a surgical procedure which is performed when a patient has lost normal bowel or bladder function as a result of a disease, injury or other defect. Most ostomy procedures are performed on cancer patients. After the ostomy procedure has been performed, waste from the patient is expelled via a surgical opening called a “stoma” into an ostomy appliance such as an ostomy bag.

The waste includes gases and these gases can inflate the ostomy bag causing discomfort to the patient. Further, the gases can potentially overinflate the bag to the extent that the bag bursts, if left unvented. To counter the overinflation problem generally ostomy bags are provided with a vent aperture which allows the gases to leave the bag once they have passed through a filter. The filter removes the foul odour of the gases as they leave the ostomy bag.

A filter for an ostomy bag is described in EP 2 274 068 B1. EP 2 274 068 B1 notes that it is not possible to attach a filter to a ostomy bag with purely adhesive, and therefore a combination of heat welding and adhesive is provided to attach the filter to the bag. In particular, a cover layer of the filter is provided with a peripheral flange which is welded to the bag when the filter is attached to the ostomy bag.

A problem with the EP 2 274 068 B1 filter is that it requires a welding step to be attached to the bag, leading to the use of more energy during manufacture and a long manufacturing time. In addition, the peripheral flange increases the footprint of the filter and increases waste.

It is an object of the present invention to obviate or mitigate at least one problem with prior ostomy appliances and filters for use with such appliances, and/or to provide an improved ostomy appliance and/or filter.

DETAILED DESCRIPTION OF THE INVENTION

In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which:

FIG. 1 shows a filter according to the present invention in plan;

FIG. 2 is a schematic representation showing the filter of FIG. 1 in section;

FIG. 3 is a schematic representation showing a portion of a first embodiment of an ostomy appliance incorporating the filter of FIG. 1;

FIG. 4 is a schematic representation showing a portion of a second embodiment of an ostomy appliance incorporating the filter of FIG. 1;

FIG. 5 is a schematic cross-sectional representation showing the ostomy appliance of FIG. 3 in section; and

FIG. 6 is a schematic interior plan-view showing the filter of FIG. 1 secured within the ostomy appliance of FIG. 3.

With reference to FIGS. 1 and 2, there is shown a filter 10. As shown the filter includes an adhesive layer 12, adsorbent layer 14 and a gas permeable cover layer 16. However, additional layers may be provided.

The adhesive layer 12 comprises adhesive for securing the filter 10 to a pouch of an ostomy appliance. The adhesive layer 12 may comprise an adhesive bearing material provided with adhesive on each side of the bearing material or alternatively may exclusively comprise adhesive. The adhesive layer may be double-sided adhesive tape. Suitable tapes include 3M 9495 LE Double-Sided Tape sold by 3M United Kingdom PLC of Bracknell, UK. The adhesive is optionally liquid and/or gas impermeable and therefore, in this embodiment, a central opening 24 allowing access to the adsorbent layer 14 is provided in the adhesive layer 12.

The adsorbent layer 14 is positioned on the adhesive layer 12 and the gas permeable cover layer 16 is secured to the adhesive layer 12 such that the gas permeable cover layer 16 covers the adsorbent layer 14. In this embodiment, the gas permeable cover layer 16 is directly secured to the adhesive layer, although one or more intermediate layers may be provided. As shown, the adsorbent layer 14 is positioned on the adhesive layer 12 such that a first portion 18 of a first side 19 of the adhesive layer is left uncovered by the adsorbent layer 14. The gas permeable cover layer 16 is larger than the adsorbent layer, and the first portion 18 which is uncovered by the adsorbent layer 14 is arranged outward of the adsorbent layer, on the cover layer 16. In the depicted example, a second portion 21 of the first side of the adhesive layer is covered by the adsorbent layer 14. Thus, the first portion 18 surrounds the second portion 21 and extends to an outer periphery of the adhesive layer 12. In the depicted example, the second portion 21 extends from the first portion 18 to the opening 24. Each of the first portion 18 and second portion 21 is a substantially rectangular ring-shaped area, and the first portion 18 surrounds the second portion 21. The second portion 21 surrounds the opening 24. The first portion 18 may have a first portion width (i.e. the distance between the second portion 21 and the outer periphery of the adhesive layer) of around 5 mm and the second portion 21 may have a second portion width (i.e. the distance between the first portion and the opening) of around 2.5 mm to 4 mm.

The adsorbent layer 14 of this embodiment comprises adsorbent particles in a fine fibre web, which in this embodiment comprises activated carbon; of course, alternative adsorbent layers could be used. As best shown in FIG. 1, the adsorbent layer 14 in this embodiment has a substantially rectangular outer profile. In particular, in the depicted example, the outer profile of the adsorbent layer 14 is a rectangle with rounded corners. Of course, those skilled in the art will appreciate that other shapes could be used instead.

As shown a second side of the adhesive layer 12 may include an adhesive region that surrounds the opening 24, and the adhesive region may overlap an outer perimeter of the adsorbent layer 14. In particular, the adhesive region of the second side of the adhesive layer 12 is provided across an entirety of the second side of the adhesive layer 12 and comprises a window which defines the opening 24.

As shown, the gas permeable cover layer 16 is secured to the first portion 18 of the adhesive layer 12. In this embodiment, the gas permeable cover layer 16 is directly secured to the first portion 18 of the adhesive layer 12. However, the gas permeable cover layer 16 may be indirectly secured to the first portion 18 of the adhesive layer 12.

In this embodiment, the adsorbent layer 14 comprises a first adsorbent layer side 30, a second adsorbent layer side 32 opposite the first adsorbent layer side 30, and at least one connecting surface 34 connecting the first and second adsorbent layer sides 30, 32. The gas permeable cover layer 16 extends around an edge 36 where the at least one connecting surface 34 meets the second adsorbent layer side 32.

As shown best in FIGS. 1 and 2, the gas permeable cover layer 16 has an outer profile 20 and the adhesive layer 12 has a corresponding outer profile 22 which is in register with the outer profile of the gas permeable cover layer 16. In other words, the gas permeable cover and adhesive layers 16, 12 have the same outer profiles and those profiles are in total alignment. There is no overlap/underlap between the gas permeable cover layer 16 and adhesive layer 12. It should be noted that the adhesive of the adhesive layer 12 which in use secures the filter 10 to the ostomy pouch has an adhesive layer outer profile that is in register with (i.e. the same as) the gas permeable layer 16 of the filter 10.

The gas permeable cover layer 16 can be microporous and/or formed from a transparent material. The gas permeable cover layer 16 may be formed from a polypropylene support scrim, and an ePTFE membrane, which are attached to each other with polyurethane adhesive.

With reference to FIGS. 3 and 5, an ostomy appliance 100 according to the present invention includes the filter 10 of FIG. 2 secured to a pouch 42. The filter 10 is secured to the pouch 42 exclusively with the adhesive of the adhesive layer 12, and such that the filter covers a vent aperture 45 provided in the pouch 42. In the depicted example, there are two vent apertures 45 provided in the pouch and the filter 10 covers both of them. These vent apertures 45 are slits cut into the pouch. In the depicted example, the filter 10 is secured to an inner surface of the pouch 42. However, it should be understood that the filter 10 may instead be secured to an outer surface of the pouch 42.

As shown the pouch 42 may comprise an outer skin 46 and an inner wall 48. In the depicted example, the outer skin 46 is the outermost layer. The inner wall 48 is the innermost layer and defines the pouch cavity 53 into which waste from the user may fall via an inlet aperture 51 provided in the pouch 42. The inner wall 48 comprises a film.

The outer skin 46 is an optional partial or total covering for the inner wall 48 which comprises a comfort material and. In particular, the comfort material used to form the outer skin 46 is a non-woven material, which obscures the content of the bag and is typical of ostomy appliances intended for use outside a hospital environment (In a hospital environment, ostomy appliances are typically provided without a comfort material, in order that health care professionals can easily inspect the contents of the bag through the inner wall 48, which will typically be formed of a transparent film material).

As shown vent apertures 45 provided in the pouch 42 extend completely through the outer skin and inner wall 46, 48. As shown, the inlet aperture 51 is provided in the outer skin 46 and inner wall 48 opposite the vent apertures 45.

FIG. 4 shows an ostomy appliance according to a second embodiment of the present invention. The second embodiment is the same as the first embodiment aside from the fact that the ostomy appliance of the second embodiment does not include a comfort layer. The reference numerals are unchanged with respect to FIG. 3.

With reference to FIG. 5, when the ostomy appliance 100 of the first embodiment is constructed, the first step of the process is to form front and back sections 50 and 52 of the pouch 42. The front section 50 will form the clothing-facing surface of the appliance, on which the filter 10 is provided, and the back section 52 will form the body-facing surface of the appliance, on which a wafer, base-plate or coupling for a wafer or base-plate will be provided.

The front section 50 is formed by welding together a first panel 54 and a second panel 56. The first panel 54 is formed of an outer skin material that will make up the outer skin once the pouch 42 is constructed and the second panel 56 is formed of an inner wall material that will make up the inner wall 48 once the pouch 42 is constructed.

The back section 52 is formed by welding together a third panel 58 of the outer skin material and a fourth panel 60 of the inner wall material. Inlet aperture holes for forming the inlet aperture 51 are cut into the third and fourth panels 58, 60 of the back section 52 before they are welded together to form the inlet aperture. The third and fourth panels 58, 60 are welded in the region of these holes during the welding of the third and fourth panels and a wafer (not shown) or means for coupling a wafer is then fixed in position on the back section such that a patient's stoma may be put into fluid communication with the inlet aperture 51 in use.

When the first and second panels 54, 56 are welded together to form the front section 50 the first and second panels 54, 56 are welded together in the region where the filter is to be applied. Once the first and second panels 54, 56 have been welded together the vent apertures are 45 are cut in the front section 50 using a laser cutting device. During this step the first and second panels 54, 56 are held in alignment by the weld in the region where the filter is to be applied. This ensures that cuts in the first and second panels 54, 56 which form the vent apertures are in register. The filter 10 is then secured to the first panel 54 such that it covers the vent apertures 45 using exclusively adhesive. And

The front section 50 is then secured to the back section 52 by welding the two sections together around their peripheries such that the second and fourth panels 56, 60 form the inner wall 48 defining the cavity 53 and the first and third panels 54, 58 form the outer skin 46 covering the inner wall 48. In particular, the front and back sections 50, 52 are joined together around an outer periphery 59 of the pouch 42.

In this embodiment, smash welding is employed to attach the panels and front and back sections together. However, other types of welding may be employed. Indeed, other methods to welding may be employed to bond the panels, and front and back sections together, such as, for example, using adhesive.

The filter 10 is shown secured to the pouch 42 and covering the vent apertures 45 in FIG. 6. As shown, in this embodiment, the filter 10 is spaced from the outer periphery 59 of the pouch 42.

Adhesive exclusively is used to secure the filter to the pouch and no portion of the filter is welded to the pouch. This removes the need for the filter to include a peripheral flange for welding the filter to the pouch, reducing the footprint of the filter, thereby saving material and reducing waste.

Energy is saved during the manufacture of the ostomy appliance as no welding step is required to attach the filter to the pouch.

The specific construction of the filter allows the filter to be constructed in a very efficient manner with a minimally sized adsorbent layer, thereby saving material and expense.

It is thought that welding the outer skin and inner wall together may help with adhesion of the filter to the pouch.

The one or more embodiments are described above by way of example only. Many variations are possible without departing from the scope of protection afforded by the appended claims.