Patent Description:
There are many forms of ostomy pouch, for example, open and closed, one-piece or two-piece. Pouches may have various shapes and various components. Typically they comprise a cavity formed of a (normally plastic) film, frequently formed by two layers, front and rear, welded together at their periphery, with the rear layer of film (closest to the ostomate's body in use) including an aperture through which effluent can enter the pouch.

For the comfort of the ostomate, a "comfort layer" can be provided, overlying the rear film layer, and normally the front film layer too. The comfort layer is made of a material that is more comfortable against the skin than the film. Normally, the comfort layer is a non-woven material - non-woven materials are chosen for features such as cost and ease of assembly, for example because they can be easily attached to the film layers of the pouch by the same welding process that bonds the film layers to one another at their periphery.

More recently, however, as part of efforts to make ostomy pouches seem less "medical", and more attractive to users, woven materials have been introduced as the comfort material of the Salts (RTM) Confidence BE (RTM) product, with the product being described in advertising material as "stylish". A woven material is more likely to be mistaken by others noticing the pouch as an undergarment, rather than as a medical appliance.

Whilst this is considered desirable, the production of an ostomy pouch with a woven comfort layer is considered to be complex. The Salts (RTM) Confidence BE (RTM) product appears to include a complete layer of specially chosen film material adjacent the woven layer. Thus in one example, moving from the ostomate out, there is: a rear woven comfort layer; an opaque rear wall defining one side of a cavtiy; a clear front wall defining the other side of the cavity; an opaque intervening wall; and, a front woven comfort layer. The front comfort layer is provided in two parts, top and bottom separated by a split and overlapping in the region of the split, so that the comfort layer can be pulled apart att the split to inspect the contents through the clear wall. The intervening layer is similarly provided in two parts, bonded (only) to the periphery of the two parts of the comfort layer. In this example, the intervening wall appears to avoid fraying of the edges of the comfort layer; avoid visibility of the contents; or aid in the processability of the (somewhat stretchy) fabric that it is adhered to.

This additional wall has a number of drawbacks for the pouch including: increased complexity of construction, increased cost; increased bulk, and increased noise in use as there is yet another (separate) layer which can rustle making the pouch less discreet.

Other prior art documents have also proposed use of woven materials as one option in comfort layers, for example, <CIT> discloses a pouch which effectively integrates the walls of the pouch which form the cavity with the comfort layer. Thus a laminate is proposed including a fabric layer which can be a knit fabric, a woven fabric or a non-woven fabric, with the fabric layer adhered to a film layer by a layer of adhesive that substantially continuously bonds the fabric layer to the film layer. This arrangement, whilst requiring fewer layers than that of the Salts Confidence BE product suffers other disadvantages, for example, a typical comfort layer includes regions not adhered to the film layers that make up the cavity, such that the comfort layer can be pulled aside and the interior inspected, but this would not be possible with the pouch of <CIT> on account of the comfort layer being substantially continuously bonded to the wall of the pouch.

<CIT> also makes reference to a comfort layer comprising at least one fabric layer and at least one film layer, with the film layer optionally laminated to the at least one fabric layer over the entire area of the at least one fabric layer. No explanation is provided as to which side of the fabric layer should be provided with the film layer, nor any details of the lamination. In looking to work this aspect of the invention, those skilled in the art could be expected to use an intervening adhesive layer between the film and the fabric, just as in the laminate of <CIT>.

Against that background, <CIT> proposed an ostomy pouch comprising a cavity for storing stomal output; the cavity defined by a rear wall and a front wall joined at their peripheries and formed of flexible sheet material as is typical. In this ostomy pouch, a sheet of woven comfort material covers the outside surface of the front wall and has a web of EVA hot-melt adhesive on the inside surface of the comfort material. Except at the periphery where the comfort material is bonded to the front wall, at least part of the web of EVA hot-melt adhesive is adjacent, facing and unbonded to the outside surface of the front wall.

In <CIT> the web of hot melt adhesive comprises a mass and a plurality of voids in the mass which is considered to be advantageous over a "full film" in terms of requiring reduced material compared to a full film, as well as avoiding the rustling associated with films.

However, a disadvantage has been identified with using a web of EVA hot melt adhesive as disclosed in <CIT>, in that when the EVA-coated comfort material is attached at the periphery (P) of the pouch to the walls of the cavity (by plastic-welding) the hot melt adhesive leaks through the comfort material as shown in <FIG> causing darkened spots (S) which make the edge of the pouch unattractive.

<CIT> discloses a film/nonwoven laminate which incorporates a low gauge machine direction oriented film layer laminated to a nonwoven support layer. The individual layers are designed such that the film layer in the laminated state has an elongation at break value in the cross machine direction that is greater the elongation at peak load value for the nonwoven layer in the same direction. Consequently, if the laminate is subjected to severe stretching forces in the cross machine direction, the nonwoven layer will fail before the film layer. In addition, the laminate has a peak load value of at least <NUM> grams. As a result, the laminate is particularly useful as, for example, an outercover material for personal care absorbent articles.

It is an object of embodiments of the present invention to at least partially overcome or alleviate the above problems.

In this specification, the term "stomal output" refers to any gases or fluids or solids produced by an ostomate that may be secreted from the stoma or that exit the stoma. The stomal output may comprise stomal gas, stomal liquid and stomal solids.

In this specification, the term "stoma" refers to an opening in the body. Generally the stoma is a surgical opening in the torso of the body. In some instances, the term "stoma" also refers to internal tissue, organs or portions thereof that are exposed by the opening. By way of non-limiting example, internal tissue may be selected from colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be an end or a loop of a small or large intestine.

In this specification, the term "ostomate" refers to a subject that may have use of the ostomy pouch disclosed herein. While ostomate usually refers to a subject with a surgical opening, as used herein, "ostomate" may refer to a subject who has a stoma, regardless of whether the stoma was created by surgery or other means.

The term "user" may refer to an ostomate, or to another person assisting the ostomate, for example, with emptying of the stomal output from the cavity.

In this specification, the ostomy pouches disclosed herein may, for example, be used for managing a stoma created by an esophagostomy, a gastrostomy, a cholecystostomy, a choledochostomy, a cecostomy, a colostomy, a duodenostomy, an ileostomy, a jejunostomy, an appendicostomy, a tracheostomy, a urostomy, a nephrostomy, an ureterostomy, or a vesicostomy. The ostomy pouches disclosed herein may be used with additional devices including, but not limited to, a shunt, a catheter, a plug or a fecal management system.

Beneficially, the ostomy pouches of the present disclosure may permit an ostomate to increase the period of use of each ostomy pouch compared to prior art pouches. This may be achieved, for example, by providing an increased cavity volume for the ostomy pouch while maintaining ostomate discretion and comfort. Additionally or alternatively, this may also be achieved by providing means for draining the cavity of stomal output reliably and hygienically so as to increase an ostomate's confidence in reusing the ostomy pouch compared to some prior art pouches. Since the ostomate may be inclined to use each ostomy pouch of the present disclosure for longer, the total number of ostomy pouches used by the ostomate in a given time period may be reduced. This may produce an environmental benefit in reducing the amount of environmental waste produced.

In this specification locations and orientations of features may be described with reference to the ostomy pouch being "in use", "orientated as it would be in use" or similar. Such terms refer to the intended orientation of the ostomy pouch when it is adhered to a body of an ostomate with the ostomate in a standing position, irrespective of whether the ostomy pouch is currently performing such a use or the actual position of the ostomate. The terms "upper" and "lower" and related terms refer to the relative position of a part or portion of the ostomy pouch when orientated as it would be in use. For example, a section of the ostomy pouch may be referred to as an "upper" section of the ostomy pouch. In such an example, said section will be intended to be the uppermost section (in the vertical direction) of the ostomy pouch when attached to the body of a standing ostomate. However the reader skilled in the art will appreciate that before attachment to the ostomate said section may not always be the uppermost section and in addition when attached the section may not always be the uppermost section if the ostomate adopts a non-standing position, for example lying down.

The terms "left-hand" and "right-hand" and related terms refer to the ostomy pouch when viewed from the rear (for example, as shown in <FIG>). Thus, as an illustrative example, a "left-hand" edge of the ostomy pouch will be towards a left-hand side of the ostomate in the situation where the ostomy pouch is attached to the front torso of the ostomate.

The terms "concave" and "convex" and related terms refer to shaping of features of the ostomy pouch when viewed from an exterior of the ostomy pouch. Thus, as an illustrative example, an ostomy wafer of circular shape would be considered to have a convexly shaped peripheral edge.

In this specification the terms "front" and "rear" refer to the relative position of a part or portion of the ostomy pouch with reference to the body of an ostomate when the ostomy pouch is attached to the body. "Rear" refers to a position relatively closer to the body of the ostomate than a comparative position that is "front". "Front" refers to a position relatively further away from the body of the ostomate than a comparative position that is "rear".

In this specification the term "smoothly blends" and related terms refers to the smooth merging of two edges, lines or contours without abrupt changes in contour.

In this specification the term "peripheral region" refers to a portion situated on or towards an edge of the item being referred to.

The term "turned up" used herein may include folding or rolling of the components.

Ostomy pouches are commonly attached to the body by means of an ostomy wafer which includes an adhesive layer or layers. The ostomy wafer typically has an opening for the stoma sometimes referred to as a starter hole which may be cut to a required size by a user before attachment. The ostomy wafer typically comprises an adhesive layer on a body-facing side for adhering the ostomy wafer to the body of the ostomate. Typically, a release liner covers a body-facing side of the ostomy wafer that is removed by the user prior to fitting to the skin. In this specification, the term "ostomy wafer" may be used interchangeably with the terms "adapter," "wafer," "baseplate", or "layered adhesive wafer. " In this specification, the term "ostomy wafer" includes ostomy wafers for a "two-piece pouch" and for a "one-piece pouch".

In this specification a "two-piece pouch" refers to a pouch where the ostomy wafer forms part of a separate body fitment component that is attached by a releasable coupling to the remainder of a pouch. A two-piece pouch permits the body fitment component to be separated from the pouch without damage, so that at least one of the parts continues to be functionally usable. For example, the body fitment component may remain in place on the body of the ostomate.

In this specification a "one-piece pouch" refers to a pouch where the ostomy wafer is permanently attached to the pouch, to the extent that the ostomy wafer cannot easily be separated without risk of damaging the pouch. A one-piece pouch is intended to be used as an integral unit.

Ostomy pouches are commonly configured as closed pouches or open pouches. In this specification a "closed pouch" refers to an pouch where it is not intended that stomal output is drained from the cavity. Thus, a closed pouch may typically be configured as a one-use, disposable and non-reusable pouch. In this specification an "open pouch" refers to an pouch where it is intended that stomal output is drained from the cavity. Thus, an open pouch may be configured as a reusable pouch, such that it can be reused and emptied multiple times whilst attached to the body, although this is not essential. In an open pouch the stomal output may be drained intermittently as instigated by an action of the ostomate or may be drained intermittently or continuously due to the cavity being fluidly connected to a drain, for example a night drain line.

The present invention provides an ostomy pouch having the features defined claim <NUM>.

A continuous layer of film material is to be understood as a "solid" layer having no voids, in contrast to that of <CIT>.

Such layers of film material do not have the same propensity to leak through a woven material when the comfort material is welded to the walls of the cavity - because forming a web, mesh, net or the like, typically requires a spray coating technique (either spraying onto the comfort material, or spraying to form a layer, that is formed into a roll and laminated to the comfort material (as disclosed in <CIT>)); as such, to be spray-coated, the inventors understand that the EVA hot melt adhesive must necessarily have a relatively low viscosity, or other characteristics which lead to the problematic leaking through the comfort material. Without being bound by the theory, the inventors believe that a material with a higher viscosity will be less likely to flow through the comfort material and can be easily produced as a continuous film; as such, those skilled in the art can, in light of this disclosure, easily select continuous films with appropriate characteristics to avoid this issue.

Obviously, as compared to the Salts (RTM) Confidence BE (RTM) product the ostomy pouch of the first aspect of the invention has advantages such as the lack of a separate intervening layer, hence less rustling. Moreover, as the film layer is laminated to the woven comfort material, with no intervening adhesive layer, the process of attaching the comfort layer to the cavity is simplified, because the already-laminated woven layer can be attached directly to the films forming the cavity, so fewer rolls of material need to be joined in the manufacturing process.

As compared to <CIT>, of course, the advantages are much the same as they are in <CIT>.

The continuous layer of film material may have an even thickness (i.e. a substantially even thickness) across the entire surface of the sheet of woven comfort material. The deviation in thickness across the entire surface of the film material may be less than <NUM> microns, preferably less than <NUM> microns, more preferably less than <NUM> microns, such as less than <NUM> microns.

The continuous layer of film material may have a thickness (i.e. an average thickness) of less than <NUM> microns (preferably less than <NUM> microns, more preferably less than <NUM> microns) across the entire surface of the sheet of woven comfort material. The continuous layer of film material may have a thickness of at least than <NUM> microns (preferably more than <NUM> microns, more preferably more than <NUM> microns) across the entire surface of the sheet of woven comfort material. For example, the continuous layer of film material may have a thickness of between <NUM> and <NUM> microns, e.g. <NUM> to <NUM> microns, such as about <NUM> microns across the entire surface of the sheet of woven comfort material.

The continuous layer of film material may have an area density of at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM>/m<NUM>, and/or no more than <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM>/m<NUM> preferably <NUM>-<NUM>/m<NUM>, <NUM>-<NUM>/m<NUM>, <NUM>-<NUM>/m<NUM>, or <NUM>-<NUM>/m<NUM>, for example <NUM>/m<NUM>.

Accordingly in one preferred embodiment there is provided an ostomy pouch comprising a cavity for storing stomal output; the cavity defined by a rear wall and a front wall joined at their peripheries and formed of flexible sheet material; the ostomy pouch further comprising a sheet of woven comfort material covering the outside surface of the front wall; the sheet of comfort material having an outside surface and an opposite inside surface, wherein the outside surface of the sheet of comfort material forms at least part of the outside surface of the pouch, and the inside surface of the sheet of comfort material is laminated across its entire surface to a continuous layer of film material, with no intervening adhesive; at least part of the continuous layer of film material being adjacent, facing and unbonded to the outside surface of the front wall; wherein the continuous layer of film material has has no voids.

The continuous layer of film material is formed of a material which bonds to the material of the comfort layer without the need for an intervening adhesive. As such, the continuous layer of film material may be a continuous layer of hot-melt adhesive material.

The continuous layer of film material may be formed of the same material as the front wall and the rear wall. This improves attachment of the comfort material to the cavity, because the two materials will typically melt at the same temperature in a plastic-welding step and bond well to one another.

The continuous layer of film material and the front and rear walls may be formed of polymers with the same chemical structure. The continuous layer of film material and the front and rear walls may be formed of polymers with the same molecular weight Mn. The continuous layer of film material and the front and rear walls may be formed of polymers with the same melting point, Mp. The continuous layer of film material and the front and rear walls may be formed of polymers obtained from the same source, with the same designation. Using polymers obtained from the same source, and having the same designation should ensure that other characteristics defining the similarity (e.g. structure, Mn, Mp) can be relied upon to be the same, without the need for measurement.

The continuous layer of film material is preferably formed of EVA. The continuous layer of film material may alternatively be formed of another plastics material, for example polyethylene, provided the film is selected to have suitable properties in terms of being able to bond to the comfort material without an intervening adhesive layer and without leaking through.

The pouch may have a front and a rear. The sheet of woven comfort material may form at least part of the front surface of the pouch. The front and rear surfaces of the pouch may be both formed by sheets of woven comfort material. As such, the ostomy pouch may further comprise a sheet of woven comfort material covering the outside surface of the rear wall; the sheet of comfort material having an outside surface and an opposite inside surface, wherein the outside surface of the sheet of comfort material forms at least part of the outside surface of the pouch, and the inside surface of the sheet of comfort material is laminated across its entire surface to a continuous layer of film material; at least part of the continuous layer of film material being adjacent, facing and unbonded to the outside surface of the rear wall.

Such an embodiment of the present invention therefore provides a pouch covered on both sides (front and rear) in woven comfort material that provides enhanced comfort for the user and which has a continuous layer of film material laminated to the sheet of comfort material so that the pouch can be easily manufactured without additional welding steps or the introduction of intermediate layers and does not suffer from adhesive leaking through the comfort layer. Effectively, the laminated sheets of comfort material can be bonded to the remainder of the pouch, for example a front wall defining one side of a cavity and a rear wall defining the other side of a cavity, in just the same way as a non-woven material would be bonded - typically a single step welding process whereby the peripheries of all the layers are bonded to each other.

The woven comfort material may comprise a natural material, for example cotton or wool and/or a synthetic material, for example any one or more of polyester, nylon, viscose, polyethylene, polypropylene, or the like. The woven material may have an area density of <NUM> to <NUM>/m<NUM>, preferably <NUM>-<NUM>/m<NUM>, for example <NUM>/m<NUM>. The woven material may have a tensile strength of <NUM> to <NUM> N, preferably <NUM> to <NUM> N, for example 300N in the warp and 280N in the weft. The woven material may have a tear strength of <NUM> to <NUM> N, preferably <NUM>-30N, for example <NUM> N. The woven material may have a colour fastness to any one or more of rubbing, perspiration or washing (<NUM>°) of <NUM> to <NUM>. The woven material may have an abrasion of ><NUM>,<NUM>. The woven material may have a water resistant finish. For example, it may comprise woven polyester with a water repellent finish. The water repellent finish may be fluorocarbon based. The water repellent finish may be dyed heat set or boil off heat set.

The woven comfort layer may have a thickness of <NUM> to <NUM> micrometres, preferably <NUM> to <NUM> micrometres, more preferably <NUM> to <NUM> micrometres.

The rear wall and front wall may be substantially the same shape. The rear wall and front wall may be formed of plastics film. The rear wall and/or front wall may be opaque. The rear wall and/or front wall may be transparent. In particular at least part of the front wall may be transparent. The rear wall and/or front wall may be formed for example of any one of polyurethane, polyethylene (PE), polyvinylidene chloride (PVDC), or ethylene-vinyl acetate (EVA). The rear wall and/or front wall may each have a thickness of <NUM> to <NUM>. The rear wall and/or front wall may each have a thickness of <NUM> to <NUM>. The rear wall and front wall may have corresponding inside and outside surfaces. The inside surfaces of the rear and front walls may form the interior of the cavity. The outside surfaces of the rear and front walls may form the exterior of the cavity. The sheet of woven comfort material may be substantially the same shape as the front wall. A/the sheet of comfort material may be bonded to the outside surface of a wall of the cavity at the periphery, but unbonded to the wall other than at the periphery.

The sheet of woven comfort material covering the front of the pouch may comprise one or more parts. The sheet of woven comfort material covering the front of the pouch may comprise an upper part and a lower part. The upper part and lower part when taken together may be the same shape as the front wall. The upper part may extend from a top edge of the pouch to a point <NUM> - <NUM>% down its length from the top. The lower part may extend from a bottom edge of the pouch to a point <NUM> - <NUM>% down its length from the top. An overlap region may be provided where the upper part and lower part overlap. The upper part may extend over the lower part (or vice versa) to form the overlap in the overlap region. The upper part and the lower part may be separable from each other in the overlap region. The overlap region may extend horizontally when the ostomy pouch is in use. Thus, especially when the front wall is formed of a transparent film, the present invention provides a device that can permit convenient viewing of the stoma and/or the contents of the pouch if required.

The pouch may comprise a drain. The drain may be disposed at the bottom of the pouch in use. The drain may be formed from the front and rear walls of the pouch. The drain may be rectangular. The drain may be foldable. The drain may be foldable along its length. The drain may be movable between a folded and unfolded configuration. The drain may be in a closed state in its folded configuration. The drain may be in an open state in its unfolded configuration. When open, the drain may permit stomal output to leave the cavity of the pouch. When closed, the drain may prevent stomal output leaving the cavity of the pouch.

The drain may be provided with one or more pursing strips. The or each pursing Strip may span the width of the drain. The or each pursing strip may extend the same distance along the length of the drain. The or each pursing strip may provide localised rigidity to the drain. The or each pursing strip may be formed from polystyrene. The or each pursing strip may define the locations and orientations of one or more folds of the drain. The or each pursing strip may comprise a strip of flexible material attached drain. The strip may have a higher rigidity than the material of the drain. The or each pursing strip may have some resilience once attached to the drain. Therefore, the pursing strips can be squeezed laterally to arch the pursing strip and thereby assist in opening the drain.

A pursing strip may be provided on the rear wall. The pursing strip may be provided adjacent a bottom end of the drain. The pursing strip may be provided on the outside surface of the rear wall. A pursing strip may be provided on the front wall. The front wall pursing strip may be provided on the outside surface of the front wall. The front wall pursing strip may be provided above the rear wall pursing strip. The front wall pursing strip may be provided midway between a top end and the bottom end of the drain. A longitudinal gap may be provided between an upper edge of the rear wall pursing strip and a lower edge of the front wall pursing strip. The longitudinal gap may define the location of a first fold of the drain.

A fastening element may be disposed on an outside surface of the rear wall. The rear fastening element may be disposed above the front pursing strip. A longitudinal gap may be provided between an upper edge of the front wall pursing strip and a lower edge of the second fastening element. The longitudinal gap may define the location of a fold of the drain. The rear fastening element may be disposed adjacent the top end of the drain.

A closure mechanism for the drain of the ostomy pouch may be attached to a sheet of comfort material covering the front of the pouch. The closure mechanism may be attached to the outside surface of the comfort material. The closure mechanism may be a closure flap. The closure flap may be welded to the woven comfort material. The weld may be along a top edge of the closure flap. The closure flap may have an outside surface and an inside surface. The inside surface of the closure flap may be adjacent the outside surface of the comfort material. The closure mechanism may comprise a front fastening element. The front fastening element may co-operate to fasten with the rear fastening element. Fastening of the fastening elements may close the drain.

The closure flap may comprise a woven comfort material (optionally comprising the continuous layer of film material). This is desirable as forming the closure flap of the same material as the comfort material makes it more subtle/discreet.

The front fastening element may be disposed above the rear fastening element. The front fastening element may be disposed adjacent a bottom edge of the comfort material. A longitudinal gap may be provided between an upper edge of the rear fastening element and a lower edge of the front fastening element. The longitudinal gap may define the location of a fold of the drain. The rear fastening element may be disposed adjacent the top end of the drain.

The drain may be closed by repeatedly folding the drain upwards about the fold lines defined by the front and rear pursing strips and front and rear fastening elements. The folded drain may be retained between the woven comfort material and closure flap. The sides of the closure flap may not extend beyond the edges of the comfort material. The closure flap may comprise a tab. The tab may extend beyond the bottom edge of the comfort material. The front and rear fastening elements may be the same size. The front and rear fastening elements may not span the width of the drain.

Therefore, the drain can be conveniently closed against the comfort material and secured in place with the closure flap. It is therefore not necessary to fold or secure the drain beneath the comfort material, making the pouch easier to use. The provision of a tab makes unfolding of the drain easier as the closure flap can be lifted allowing access to undo the fastening elements, as does the inclusion of fastening elements that do not span the entire drain width.

According to a second aspect of the invention, there is provided a method of forming a comfort layer laminate for bonding to a cavity of an ostomy pouch; the method comprising laminating a continuous layer of film material directly to a sheet of woven comfort material, with no intervening adhesive layer.

Preferably the continuous layer of film material is laminated to the sheet of comfort material under conditions of elevated (w. t ambient) temperature and pressure, for example by calendaring.

Of course, the comfort layer and the film material may have any of the features outlined above, such as the materials outlined, and/or the maximum thickness, which makes the layer of film material suitable as a backing for a comfort layer, which should be easily conformable, but unsuitable for forming a wall of a cavity.

The layer of comfort material is woven. So there is provided a method of forming a comfort layer laminate for bonding to a cavity of an ostomy pouch; the method comprising laminating a continuous layer of film material directly to a sheet of woven comfort material, with no intervening adhesive layer.

Naturally, the method should form a material in which the layer of comfort material remains continuous, i.e. no steps in the method should introduce voids or apertures. As such in one embodiment there is provided a method of forming a comfort layer laminate for bonding to a cavity of an ostomy pouch; the method comprising laminating a continuous layer of film material directly to a sheet of comfort material, with no intervening adhesive layer to form a sheet of woven comfort material having an outside surface and an opposite inside surface, wherein the inside surface of the sheet of comfort material is laminated across its entire surface to a continuous layer of film material, with no intervening adhesive; the continuous layer of film material being an uninterrupted, "solid" layer having no voids.

According to a third aspect of the present invention, there is provided a method of forming an ostomy pouch, as defined in claim <NUM>.

The step laminating a continuous layer of film material directly to a sheet of comfort material, may be conducted separately from the step of bonding the inside surface of the sheet of woven comfort material to a wall of the pouch. For example, it may be conducted temporally separately, e.g. a least <NUM> minutes, <NUM> minutes, <NUM> hour, <NUM> hours, or <NUM> hours before bonding the inside surface of the sheet of comfort material to the wall. Alternatively/additionally, the step of laminating a continuous layer of film material directly to a sheet of comfort material may be conducted physically separately from the step of bonding the inside surface of the sheet of woven comfort material to a wall of the pouch. For example it may be conducted in a separate room, separate building or separate city, county or state.

Accordingly, in one embodiment, there is provided a method of forming an ostomy pouch comprising first forming a comfort layer laminate for application to a cavity of an ostomy pouch; the method comprising laminating a continuous layer of film material directly to a sheet of comfort material, with no intervening adhesive layer, to provide a sheet of comfort material having a continuous layer of film material laminated across the entirety of a first surface; and then forming an ostomy pouch, by bonding only part of the first surface of the sheet of comfort material to the outside surface of a wall of a cavity of the ostomy pouch whereby at least part of the continuous layer of film material is adjacent, facing and unbonded to the outside surface of the front wall; wherein the step laminating a continuous layer of film material directly to a sheet of comfort material, is conducted temporally separately from the step of bonding the inside surface of the sheet of woven comfort material to a wall of the pouch, at least <NUM> hours before bonding the inside surface of the sheet of comfort material to the wall.

Preferably the method comprises bonding the first surface of the sheet of comfort material to the periphery of the wall of the cavity of the ostomy pouch. preferably the method of bonding is welding.

Preferably the cavity is defined by a rear wall and a front wall joined at their peripheries and formed of flexible sheet material. The method may comprise providing a rear wall and a front wall formed of flexible sheet material and joining them at their peripheries. The method may include bonding the inside surface of the sheet of comfort material to one or more of the rear and/front wall of the ostomy pouch at the periphery thereof. The method may comprise simultaneously joining the front wall and the rear wall of the cavity, and bonding part of the first (inside) surface of the sheet of comfort material to at least one of the walls of the cavity.

The sheet of comfort material may comprise two or more parts and the method may include arranging a plurality of parts of a sheet of comfort material, and bonding the plurality of parts of a sheet of comfort material to the pouch. The bonding of the plurality of parts may be performed simultaneously. The bonding may be performed by welding. Thus, the present invention allows for complex arrangements of material to be applied to the pouch in a single manufacturing step, reducing the complexity and cost of production.

Unless defined otherwise, all technical and scientific terms used in this specification have the same meaning as is commonly understood by the reader skilled in the art to which the claimed subject matter belongs. It is to be understood that the foregoing summary of the disclosure and the following examples are exemplary and explanatory only and are not restrictive of any subject matter claimed.

The following description is directed to embodiments of the disclosure. The description of the embodiments is not meant to include all the possible embodiments of the disclosure that are claimed in the appended claims. Many modifications, improvements and equivalents which are not explicitly recited in the following embodiments may fall within the scope of the appended claims. Features described as part of one embodiment may be combined with features of one or more other embodiments unless the context clearly requires otherwise.

In this specification, the use of the singular includes the plural unless the context clearly dictates otherwise. In this application, the use of "or" means "and/or" unless stated otherwise. Furthermore, use of the term "including" as well as other forms, such as "include", "includes," and "included," is not limiting.

As used herein, ranges and amounts can be expressed as "about" a particular value or range. About also includes the exact amount. For example, "about <NUM>" means "about <NUM>" and also "<NUM>. " Generally, the term "about" includes an amount that would be expected to be within experimental error. The term "about" includes values that are within <NUM>% less to <NUM>% greater of the value provided. For example, "about <NUM>" means "between <NUM> and <NUM>.

Referring to <FIG>, an embodiment of the invention is shown in which an ostomy pouch <NUM> comprises a rear wall <NUM>, a front wall <NUM>, a separation wall <NUM>, a rear comfort layer <NUM>, a front comfort layer <NUM> and an ostomy wafer <NUM>. In other embodiments within the ambit of the invention as claimed, one or more of the separation wall <NUM>, the rear comfort layer <NUM> and the front comfort layer <NUM> may be omitted if desired.

In this embodiment, the ostomy pouch <NUM> is a one-piece pouch wherein the ostomy wafer <NUM> is permanently attached to the ostomy pouch <NUM> (in the sense that it cannot be easily removed and re-attached without damaging the pouch). However, other embodiments may be a two-piece pouch comprising a pouch component and body fitment component that together form the ostomy pouch. In some of these embodiments, the pouch comprises the rear wall <NUM>, the front wall <NUM>, the separation wall <NUM>, the rear comfort layer <NUM> and the front comfort layer <NUM>, and the body fitment component comprises the ostomy wafer <NUM>.

The rear wall <NUM> and the front wall <NUM> define a cavity for containing a stomal output. In this embodiment, the rear wall <NUM> and the front wall <NUM> are both formed of flexible sheet material in the form of a plastics film and are joined together to define the cavity. An exemplary film is Ethylene-vinyl acetate (EVA). The film typically has a thickness of <NUM> to <NUM> but in some embodiments may have a thickness of <NUM> to <NUM>.

In this embodiment, the ostomy pouch <NUM> has an upper section <NUM>, a lower section <NUM> and a waisted section <NUM> that is located between the upper section <NUM> and the lower section <NUM>. The upper section <NUM> has a maximum width, A, the lower section <NUM> has a maximum width, B, and the waisted section, <NUM>, has a minimum width, C. In this embodiment, the maximum width, A, of the upper section <NUM> is greater than the maximum width, B, of the lower section <NUM>, which in turn is greater than the minimum width, C, of the waisted section <NUM>.

In this embodiment, the ostomy pouch <NUM> has a left-hand <NUM> and right-hand <NUM> edge when viewed from the rear. The waisted section <NUM> has a left-hand edge 13c and a right-hand edge 14c that are both smoothly rounded and merge into the respective left-hand edges 13a, 13b and right-hand edges 14a, 14b of the upper section <NUM> and the lower section <NUM>.

The shape and dimensions of the ostomy pouch <NUM> are not particularly limited so long as it remains discreet and comfortable to wear in use. Exemplary dimensions and other suitable shapes are set out in the prior art documents cited in the introduction, such as <CIT>.

In this embodiment, the left-hand edge 13c and the right-hand edge 14c of the waisted section <NUM> have concave curvature with a radius of curvature, r1.

In this embodiment, both the upper <NUM> and lower <NUM> sections are rounded and comprise continuously curved edges <NUM>, <NUM> respectively. The curved edges <NUM>, <NUM> extend from the upper and lower ends of left-hand edge 13c of the waisted section <NUM> to the corresponding upper and lower ends of the right-hand edge 14c of the waisted section <NUM>. The edges <NUM>, <NUM> are convexly curved with a radius of curvature of r2 and r3 respectively. In this embodiment, the r2 and r3 are constant along their respective edges <NUM>, <NUM>, however in alternative embodiments they may be variable.

In this embodiment, the upper section edge <NUM> incorporates the left-hand edge 13a and the right-hand edge 14a of the upper section <NUM> while the lower section edge <NUM> incorporates the corresponding left-hand 13b and right-hand edge 14b of the lower section.

In this embodiment, a junction between the upper section <NUM> and the waisted section <NUM> may be demarcated by a single point of inflection <NUM> between the edges 13a, 14a of the upper section <NUM> and the edges 13c, 14c of the waisted section <NUM>. Similarly, a junction between the lower section <NUM> and the waisted section <NUM> may be demarcated by a single point of inflection <NUM> between the edges 13b, 14b of the lower section <NUM> and the edges 13c, 14c of the waisted section <NUM>.

The rear wall <NUM> and front wall <NUM> are joined around their peripheral edges by use of welding. Welding is a preferred method of joining the rear wall <NUM> and the front wall <NUM> as it allows all the layers of the pouch <NUM> to be joined simultaneously, as described later.

In this embodiment, the rear wall <NUM> and the front wall <NUM> are joined together by a single continuous edge seal <NUM> that extends around a full perimeter of the rear wall <NUM> and the front wall <NUM> to create a fluid-tight seal.

The rear wall <NUM> is provided with a stomal inlet <NUM> for receiving the stomal output into the cavity. The stomal inlet <NUM> is an aperture that is cut out of the rear wall <NUM> in the upper section <NUM> of the ostomy pouch <NUM>, in which the wafer <NUM> is provided, the wafer having a hole through which a stoma normally extends.

In this embodiment, the rear comfort layer <NUM> and front comfort layer <NUM> are substantially the same shape as the rear <NUM> and front <NUM> walls. The rear <NUM> and front <NUM> comfort layers form the outside of the ostomy pouch <NUM> and cover the rear <NUM> and front <NUM> walls respectively. The rear comfort layer <NUM> also comprises a wafer aperture that is in register with the stomal inlet <NUM> of the rear wall <NUM>, in which the wafer <NUM> is arranged.

The rear comfort layer <NUM> and the front comfort layer <NUM> are formed of a flexible sheet material comprised of a woven fabric layer which is laminated across its entire surface to a continuous layer of film material. The continuous layer of film material forms an uninterrupted, solid layer having no voids, thus completely covering one surface of the comfort layer <NUM>, namely its inside surface in use.

In this embodiment, the fabric layer forms the outside surface of the rear <NUM> and front <NUM> comfort layers respectively, with the continuous layer of film material disposed on the corresponding inside surfaces, facing the rear <NUM> and front <NUM> walls. Other embodiments may comprise additional fabric layers and/or film layers as required. In this embodiment, the woven fabric layer comprises polyester but in other embodiments any one or more of nylon, viscose, polyethylene and polypropylene could be used in addition or as an alternative.

In this embodiment, the woven fabric layer has an area density of <NUM>/m<NUM>, a tensile strength of <NUM> to <NUM> N, and a tear strength of <NUM> N. Other embodiments may have different compositions, for example an area density of <NUM> to <NUM>/m<NUM>, a tensile strength of <NUM> to <NUM> N, and a tear strength of <NUM> to <NUM> N. Some embodiments may also have a colour fastness to any one or more of rubbing, perspiration or washing (<NUM>°) of <NUM> to <NUM>, and an abrasion of ><NUM>,<NUM>. Certain embodiments also comprise a woven polyester with a water repellent finish. The water repellent finish may be fluorocarbon based and may be dyed heat set or boil off heat set. A suitable woven polyester layer is available from Newton Textiles Limited of Northamptonshire, UK, under the 75DCWR Designation, such as 75DCWRWHITE (for a white variant).

In this embodiment, continuous layer of film material comprises ethylene-vinyl acetate (EVA).

In this embodiment, the continuous layer of film material has an area density of <NUM>/m<NUM>. A suitable EVA film is available from Protechnic SA of Cernay, France under the designation 3X9S23.

The continuous layer of film material is laminated to the fabric layer over the entire area of the inside surface of the rear <NUM> and the front <NUM> comfort layers. Lamination, e.g. calendaring at elevated temperature and pressure, creates a laminate in which the continuous layer of film material extends across the entire area of the comfort layers <NUM>, <NUM> with an even thickness throughout and no voids therein. Because the EVA film in question is adhesive at elevated temperature, no intervening adhesive layer is between the continuous film and the comfort layer, rather, the continuous layer of film material is laminated directly to the comfort layer.

Advantageously, the provision of the continuous layer of film material allows both comfort layers <NUM>, <NUM> and both walls <NUM>, <NUM> to be joined together simultaneously in the same welding process if desired, in the same manner as a non-woven material would be attached, improving the bond, without the need for specialist intervening layers or the application of adhesive during the construction process. In this embodiment, the peripheral weld defined by the edge seal <NUM> also joins the rear comfort layer <NUM> to the rear wall <NUM> and the front comfort layer <NUM> to the front wall <NUM>. In other embodiments, various welds may be used as required or desired. For example, the weld may only correspond to a portion of the weld joining the rear <NUM> and front <NUM> walls. The weld attaching the rear comfort layer <NUM> to the rear wall <NUM> may be different from the weld attaching the front comfort layer <NUM> to the front wall <NUM>. In addition, the continuous layer of film material protects the fabric layers from undesirable fraying.

In this embodiment, the front comfort layer <NUM> comprises an upper part 6a and a lower part 6b, which when taken together are the same shape as the front wall <NUM>. The upper 6a extends from the top of the pouch <NUM> to the point of inflection <NUM> between the upper section <NUM> and waisted section <NUM>. The lower part 6b extends from the bottom of the pouch <NUM>, beneath the upper part 6a to a point slightly above the point of inflection <NUM>. As such, the upper 6a part partially overlaps the lower part 6b in an overlap region <NUM>. The upper part 6a and the lower part 6b are separable from each other in the overlap region <NUM> to form a window opening for viewing the cavity. The overlap region <NUM> extends horizontally when the ostomy pouch <NUM> is in use. In some embodiments, the overlap region <NUM> may not coincide with the point of inflection <NUM> and may span the pouch <NUM> at any suitable location along its length. Importantly, without the presence of the continuous layer of film material, the two parts 6a, 6b, of the front comfort layer <NUM> would not bond to one another at all, regardless of the choice of material for the walls <NUM>,<NUM>, because the material of the wall is not involved in the bond in that region.

In other embodiments, the front layer may be comprised of multiple parts. The external shape and dimensions of the multiple parts when taken together may be the same as that of the front wall <NUM>.

In this embodiment, the ostomy wafer <NUM> is in register with the stomal inlet <NUM> of the rear wall <NUM> and extends through the wafer aperture of the rear comfort layer <NUM>. The ostomy wafer <NUM> comprises an adhesive and a release liner <NUM>. The ostomy wafer <NUM> is mounted to the rear wall <NUM> by welding. In other embodiments the wafer <NUM> may be mounted by any suitable alternative means (e.g. adhesive).

The ostomy pouch <NUM> may also be provided with a gas vent for venting of stomal gases from the cavity. In this embodiment, the ostomy pouch <NUM> comprises a gas vent filter <NUM> which is also an odour filter. Suitable filters could be a charcoal or activated carbon filter, for reducing the release of unwanted odours from the cavity. The gas vent filter <NUM> forms a part of the gas vent, which comprises a gas vent aperture <NUM> located in the front wall <NUM>. In some embodiments, the gas vent filter <NUM> is covered by a filter cap and the gas vent filter <NUM> and filter cap are located on the front wall <NUM> over the gas vent aperture <NUM>. The gas vent aperture <NUM> permits the passage of gas from the cavity towards an exterior of the ostomy pouch through the gas vent filter <NUM> and filter cap.

In this embodiment, the gas vent is located, in use, in the upper quarter of the ostomy pouch <NUM>. In particular, the centre of the gas vent aperture <NUM> is disposed, in use, above the centre of the stomal inlet <NUM>. In other embodiments, the gas vent may be located elsewhere in the upper section <NUM> of the ostomy pouch <NUM>.

In this embodiment, the separation wall <NUM> is located between the rear wall <NUM> and the front wall <NUM>. The separation wall <NUM> comprises a separation filter <NUM> for filtering stomal gases and/or stomal liquids from stomal solids contained in the stomal output. The separation filter <NUM> thus prevents stomal solids from contacting the gas vent and clogging or otherwise impairing the functionality of the gas vent filter <NUM>.

In this embodiment, the separation wall <NUM> has the same external shape and dimensions as the rear wall <NUM> and the front wall <NUM> and divides the cavity of the ostomy pouch <NUM> into a first and a second chamber <NUM>, <NUM>. The first chamber <NUM> extends between the separation wall <NUM> and the rear wall <NUM>, and the second chamber <NUM> extends between the separation wall <NUM> and the front wall <NUM>. The first and second chambers <NUM>, <NUM> have substantially the same volume. In other embodiments, they may have different volumes and/or the second chamber <NUM> may have a larger volume than the first chamber <NUM>.

In this embodiment, the separation wall <NUM> is joined to the rear wall <NUM> and front wall <NUM> at their peripheral edges by use of welding to create a fluid-tight seal therebetween. In another embodiment, the separation wall <NUM> is joined to the rear <NUM> and front <NUM> walls about the whole of the edge of the upper section <NUM>, and is additionally joined to the front wall <NUM> by a horizontal weld at the interface between the upper <NUM> and waisted <NUM> sections. Therefore, the joining of the separation wall <NUM> with the rear and front walls <NUM>, <NUM> according to some embodiments of the invention may be such that the first and second chambers <NUM>, <NUM> are sealed from one another other than via the separation filter <NUM>.

In this embodiment, the separation wall <NUM> comprises a flexible sheet material, which may be formed of polyurethane, polyethylene (PE), polyvinylidene chloride (PVDC) and/or ethylene-vinyl acetate (EVA). In some embodiments, the flexible sheet material of the separation wall <NUM> has a thickness of <NUM> to <NUM> micrometres, preferably <NUM> to <NUM> micrometres. In this embodiment, the separation wall <NUM> comprises a hydrophobic and oleophobic coating applied to the flexible sheet material. In other embodiments, the flexible sheet material may be hydrophobic and/or oleophobic.

Referring to <FIG>, a further embodiment of an ostomy pouch <NUM> according to the present invention is similar to that shown in <FIG>, with like features having similar reference numerals, incremented by <NUM>. The main difference is that the lower section <NUM> of the further embodiment is shaped to accommodate/form a foldable drain. Thus, in contrast to the embodiments described above, this embodiment of the ostomy pouch <NUM> is an open pouch that does not comprise a sealed perimeter.

Moreover, in this embodiment, no separation wall is provided between the front <NUM> and rear <NUM> walls, and as such the cavity is not divided into two sections. The rear wall <NUM> features a large opening 202i in register with the stomal inlet 207i of the wafer <NUM> (which is connected to the rear wall <NUM> in the region between the periphery of the opening 202i and the periphery of the wafer, such that stomal output enters the cavity via the stomal inlet of the wafer and the opening 202i in the rear wall. The rear comfort layer <NUM> also features an opening 205i slightly larger than the opening 202i in the rear wall <NUM> and in register with it, so as to be sandwiched between teh outermost edge of the wafer and the rear wall <NUM>. The stomal inlet 207i is adjustable to fit the stoma of the ostomate.

In a similar fashion to the first embodiment, the front comfort layer <NUM> of this embodiment is formed of two parts: an upper part 206a; and a lower part 206b. The upper part 206a overlaps the lower part 206b across the majority of the width of the pouch <NUM> at a point on its height in register with the stomal inlet 207i. The overlap being defined by the lower edge <NUM> of the upper part 206a that overlaps the upper edge <NUM> of the lower part 206b.

In this embodiment, there is also an optional gas filter <NUM> positioned in the front wall <NUM> at a height above the stomal inlet 207i to allow gas to exit the pouch <NUM>. in this embodiment, the filter <NUM> is covered by an optional filter cover patch <NUM> (not shown in <FIG>) on the outside surface of the front wall <NUM>. As such, the filter <NUM> and filter cover patch <NUM> are covered by the upper part 206a of the front comfort layer <NUM>.

In this embodiment, the lower section <NUM> comprises a drain aperture <NUM>. The drain aperture <NUM> is an unsealed portion of the perimeter of the ostomy pouch <NUM> where the rear <NUM> and front <NUM> walls are not sealed.

In this embodiment, the lower section <NUM> comprises a rounded portion 211a and a substantially rectangular drain portion <NUM> that accommodates the drain aperture <NUM>, with the rounded portion 211a being adjacent the waisted section <NUM> and the drain portion <NUM> being distal the waisted section <NUM>. The drain portion <NUM> is foldable along its length between an unfolded and a folded configuration as described later.

In this embodiment, the lower section <NUM> comprises a continuous left edge <NUM> that extends from the left edge 213c of the waisted section <NUM> to a left vertex <NUM> of the drain aperture <NUM> around the curved left edge 42c of the generally rounded portion 211a and along a left edge 42d of the drain portion <NUM>. Similarly, a continuous right-hand edge <NUM> extends from the right edge 214c of the waisted section <NUM> to a right vertex <NUM> of the drain aperture <NUM> around a continuously curved right edge 43c of the generally rounded portion 211a and along a right edge 43d of the drain portion <NUM>. (Note that as <FIG> is a front view, the left edges of the pouch <NUM> are on the right of the figure and right edges of the pouch <NUM> on the left of the figure.

The left 42d and right 43d edges of the drain portion <NUM> are parallel to one another along the majority of their length.

In this embodiment, a single continuous edge seal <NUM> extends around the perimeter of the pouch <NUM> from the left vertex <NUM> of the drain aperture <NUM> to the right vertex <NUM> of the drain aperture <NUM>, leaving the distal end of the drain aperture <NUM> open.

In this embodiment, the drain portion <NUM> defines an elongate drain passage that extends from the cavity of the ostomy pouch <NUM> to the drain aperture <NUM> located at a lower end of the drain portion <NUM>. The drain portion <NUM> is integral with the lower section <NUM> and as such, the rear wall <NUM> and the front wall <NUM> may each be a single piece of material that includes the upper section <NUM>, the waisted section <NUM> and lower section <NUM> (including the drain portion <NUM>). However, in this embodiment, the rear comfort layer <NUM> and front comfort layer <NUM> do not cover the drain portion <NUM> of the rear wall <NUM> and the front wall <NUM>.

In this embodiment, communication between the cavity and the elongate drain passage is via a drain inlet <NUM> defined as the point of transition between the cavity and the drain portion <NUM>. The drain inlet <NUM> allows passage of stomal output from the cavity into the drain portion <NUM> when the drain portion <NUM> is unfolded.

In this embodiment, movement of the drain portion <NUM> between its unfolded or folded configuration opens or closes the drain aperture <NUM>. This either permits or prevents outflow of the stomal output stored in the ostomy pouch <NUM> cavity.

In this embodiment, the drain portion <NUM> can be repeatedly folded in the same sense along its length into a plurality of segments having approximately equal segment lengths and separated by folds. The drain portion <NUM> may therefore be successively folded one or more times such that the segments overlie each other. Each fold is formed across the width of the drain portion <NUM> and acts to inhibit and preferably prevent passage of stomal output out of the drain aperture <NUM>.

In this embodiment, first <NUM> and second <NUM> pursing strips are provided on the drain portion <NUM>. The pursing strips <NUM>, <NUM> provide both localised rigidity to the drain portion <NUM> and also define the locations and orientations of the segments and folds of the drain portion <NUM>. The pursing strips <NUM>, <NUM> comprise strips of flexible material attached drain portion <NUM>, wherein the strips <NUM>, <NUM> have a higher rigidity than the material of the drain portion <NUM>. The pursing strips <NUM>, <NUM> also have some resilience such that once attached to the drain portion <NUM>, the pursing strips <NUM>, <NUM> can each be squeezed laterally to arch the pursing strip and thereby open the elongate drain passage. In other embodiments, two or more pursing strips may be used.

In this embodiment, the pursing strips <NUM>, <NUM> are formed from polystyrene, but other embodiments may comprise any suitable material.

In this embodiment, the first pursing strip <NUM> is attached to the rear wall <NUM> of the drain portion <NUM> adjacent the drain aperture <NUM>. The second pursing strip <NUM> is attached to the front wall <NUM> of the drain portion <NUM> above the second strip <NUM>. A longitudinal gap is provided between an upper edge of the first pursing strip <NUM> and a lower edge of the second pursing strip <NUM>. The longitudinal gap therefore defines the location of a first fold of the drain portion <NUM>. Each pursing strips <NUM>, <NUM> spans the width of the drain portion <NUM> and extends the same distance along a length of the drain portion <NUM>.

In this embodiment, a rear fastening element 215a is arranged on the rear wall <NUM> and a front fastening element 215b is arranged on a flap <NUM> that is mounted to the front comfort layer <NUM>. In this example of a two-part front comfort layer <NUM>, the flap <NUM> is mounted to the lower part 206b of the comfort layer <NUM>. The rear fastening element 215a and the front fastening element 215b comprise corresponding hook-and-loop type fastener elements. The rear fastening element 215a is located on the drain portion <NUM> above the second pursing strip <NUM>. A longitudinal gap is provided between an upper edge of the second pursing strip <NUM> and a lower edge of the rear fastening element 215a. The longitudinal gap therefore defines the location of a second fold of the drain portion <NUM>.

In this embodiment, the flap <NUM> comprises a first flange 223a and a second flange 223b formed of one integral piece. The first flange 223a spans substantially all of the width of the lower rounded section 211a, but does not extend over the edge seal <NUM>, at a point one third up the length of the rounded section 211a from the drain inlet <NUM>. The first flange 223a is attached to the comfort material <NUM> by a single weld that spans substantially its entire width.

The flap <NUM> may be formed from the same material as the comfort layer, that is to say, a sheet of woven comfort material, with a continuous layer of film material laminated to its inside surface. A such, the weld between the outside surface of the comfort layer 206b to the flap <NUM> is made possible by the continuous layer of film material which forms the inside surface of the sheet of woven comfort material. The second flange 223b extends from the lower edge of the first flange 223a and is connected to the pouch <NUM> only by the first flange 223a. The second flange 223b is contoured so as to conform to the shape of the rounded portion 211a but is thinner, tracing the inside edge of the peripheral weld <NUM>. As such, the second flange 223b extends downwards from the first flange 223a within the perimeter defined by the edge seal <NUM> of the pouch <NUM>.

In this embodiment, the flap <NUM> has an outside surface, facing away from the ostomate in use and an opposite inside surface. The front fastening element 215b is located on the inside surface of the second flange 223b at a position above the rear fastening element 215a. A longitudinal gap is provided between an upper edge of the rear fastening element 215a and a lower edge of the front fastening element 215b and defines the location of a third fold of the drain portion <NUM>. The flap <NUM> is formed from a flexible sheet material that is more rigid than the flexible sheet material of the rear wall <NUM>, front wall <NUM> and comfort layers <NUM>, <NUM>. In this embodiment, the flap <NUM> is formed from a plastic foam which provides a desirable rigidity.

Folding of the drain portion <NUM> may be carried out as follows. First, the distal end of the drain portion <NUM> is folded upwards and away from the rear of the ostomy pouch <NUM> about the first fold line to locate the first pursing strip <NUM> over the second pursing strip <NUM>. Secondly, the drain portion <NUM> and the pursing strips <NUM>, <NUM> are folded again, in the same sense, about the second fold line and then the third fold line such that the folded and stacked first pursing strip <NUM>, second pursing strip <NUM> and first fastening element 215a are located beneath the second flange 223b of the flap <NUM> with the rear fastening element 215a being exposed and adjacent the front fastening element 215b. Finally, the second flange 223b of the flap <NUM> is pressed onto the folded drain portion to secure together the rear fastening element 215a and the front fastening element 215b.

In these embodiments, the drain portion <NUM> can then be unfolded by reversing the above procedure.

As in the first embodiment, in the second embodiment, the rear comfort layer <NUM> and the front comfort layer <NUM> are formed of a flexible sheet material comprised of a woven fabric layer with a continuous layer of film material lamiated to one surface - its inside surface in use. In this embodiment, the fabric layer is forms the outside surface of the rear <NUM> and front <NUM> comfort layers respectively, with the continuous layer of film material disposed on the corresponding inside surfaces, facing the rear <NUM> and front <NUM> walls. Other embodiments may comprise additional fabric layers and/or film layers as required. In this embodiment, the woven fabric layer comprises polyester but in other embodiments any one or more of nylon, viscose, polyethylene and polypropylene could be used in addition or as an alternative.

In this embodiment, the continuous layer of film material has an area density of <NUM>/m<NUM>. A suitable EVA film is available from Protechnic SA of Cernay, France under the designation 3X9S23.

In this embodiment, the continuous layer of film material is once again laminated directly onto the fabric layer over an entire area of the inside surface of the rear <NUM> and the front <NUM> comfort layers, with no intervening adhesive required, because the film layer itself is adhesive at elevated temperatures.

Advantageously, as in the first embodiment the use of the continuous layer of film material allows both comfort layers <NUM>, <NUM> and both walls <NUM>, <NUM> to be joined together simultaneously in the same welding process if desired, in the same manner as a non-woven material would be attached, without the need for specialist intervening layers or the application of adhesive during the construction process and with adhesion even in regions where woven layers are joined to each other (i.e. the overlap). In this embodiment, the peripheral weld defined by the edge seal <NUM> also joins the rear comfort layer <NUM> to the rear wall <NUM> and the front comfort layer <NUM> to the front wall <NUM>. In other embodiments, various welds may be used as required or desired. For example, the weld may only correspond to a portion of the weld joining the rear <NUM> and front <NUM> walls. The weld attaching the rear comfort layer <NUM> to the rear wall <NUM> may be different from the weld attaching the front comfort layer <NUM> to the front wall <NUM>.

Referring to <FIG>, apparatus for use in a method of forming the pouches of the invention is shown schematically. In this embodiment, an apparatus <NUM> comprises four rollers <NUM>, <NUM>, <NUM> and <NUM>, a stamp welding machine <NUM>, and a cutting machine <NUM>. The rollers <NUM>, <NUM>, <NUM>, <NUM> are used to advance a first <NUM>, a second <NUM>, a third <NUM> and a fourth <NUM> flexible sheet material respectively in the direction of the arrow, D. For simplicity, additional rollers used to advance the sheet material are not shown.

In this embodiment, the apparatus <NUM> is configured to construct an ostomy pouch <NUM> similar to the ostomy pouches <NUM>, <NUM> of <FIG> comprising a rear comfort layer <NUM>, <NUM>, rear wall <NUM>, <NUM>, front wall <NUM>, <NUM> and front comfort layer <NUM>, <NUM>. However, the process is shown simplified, without features such as the separation layer <NUM> or aspects of the drain portion <NUM> described in the embodiments above and without any description of the assembly of the wafer, filter and so forth, which can be provided in manner which will be well known to those skilled in the art.

The first <NUM> and second <NUM> sheets of material are plastics film used for the rear and front walls of the pouch <NUM> respectively. As such, the materials used for these sheets are the same and correspond to that described in relation to the ostomy pouches <NUM>, <NUM> described above.

In this embodiment, the third <NUM> and fourth <NUM> sheets of material are used for the rear and front comfort layers of the pouch <NUM> respectively. As described above, the material used for the comfort layers comprise a woven fabric layer with a continuous layer of film material laminated thereto. As such, the third <NUM> and fourth <NUM> sheets of material comprise a woven fabric layers 313a, 314a each having a continuous layer 313b, 314b of film material laminated thereto. In <FIG>, the layers of film material 313b, 314b face towards one another, with the first and second layers of sheet material <NUM>, <NUM> which will form the rear and front walls of the cavity arranged between them.

The third <NUM> and fourth <NUM> sheets of material have been previously formed in a separate facility, days earlier, by a laminating process, such as a calendaring process, in which a thin, but solid sheet of EVA film 313b, 314b (having no voids therein) is advanced from a roll and laminated under elevated heat and pressure directly onto sheet of woven material 313a, 313b similarly advanced from a roll, then cooled and rolled onto a new roll, on which it is delivered. As noted above, no intervening adhesive is provided between the solid sheet of EVA film and the sheet of woven material. This process creates a continuous layer of EVA film with an even thickness across the entire surface of the woven material and avoids the formation of any voids in the continuous layer of EVA film 313b, 314b. For example, with a laminate of EVA film is available from Protechnic SA of Cernay, France under the designation 3X9S23, on the woven comfort material, the entire surface can be covered by the laminate, and the thickness of the EVA film can be substantially unchanged from its starting thickness of a constant <NUM> =/-<NUM> across its entire length and width.

In this embodiment, the stamp welding machine <NUM> is arranged to weld together the layers of material using a hot stamp. The shape of the weld corresponds to the perimeter edge seal <NUM> as described in the ostomy pouches <NUM>, <NUM> of <FIG> and <FIG>.

As can be seen from <FIG> (a photograph of sheet <NUM>/<NUM> in the region of the perimeter edge seal, <NUM>, <NUM>, <NUM>) the region which has been welded is virtually indistinguishable from the remainder of the sheet of woven material <NUM>, <NUM>. This can be compared visually with the image in <FIG>, where the welded periphery (P) is clearly distinguishable, because of its mottled edge, with unsightly dark spots (S) (not all of which are labelled).

Referring back to <FIG>, in this embodiment, the cutting machine <NUM> is arranged to cut sections of the advancing sheet of material in the shape defined by the perimeter of the ostomy pouch.

In this embodiment, first, the first <NUM> and second <NUM> sheets of material are brought together by rollers (not shown) such that they are in contact and advance at the same rate as one another. Next, the third <NUM> and fourth <NUM> sheets of comfort material are brought together on opposite sides of the first <NUM> and second <NUM> sheets of film material by rollers (not shown). The third sheet <NUM> is brought adjacent to the first sheet <NUM> such that the continuous layer of film material 313b faces the first sheet <NUM>. Similarly, the fourth sheet <NUM> is brought adjacent the second sheet <NUM> such that the continuous layer of film material 314b faces the second sheet <NUM>. As such, all four sheets are in contact and advance at the same rate. The sheets thus are stacked in the following order: third <NUM>; first <NUM>; second <NUM>; and, fourth <NUM>.

In this embodiment, the advancing sheet of material then enters the stamp welding machine <NUM>. The stamp welding machine <NUM> applies the heated stamp to the advancing sheet creating a sealed weld line <NUM> that corresponds to the perimeter of the ostomy pouch <NUM>. The heated stamp can be applied either to the comfort layer which will be at the rear in use, or that which will be at the front, since direct application of heat does not cause the continuous layer of film material to leak through the fabric layer and cause unsightly mottling/spotting. This is to be contrasted with the approach of <CIT>, where despite rigorous testing of various different webs of EVA, one could not be found that did not leak through the fabric, at least on one side.

The continuous layers of film material 313b and 314b, facilitate the fabric layers 313a and 314a welding to the first <NUM> and second <NUM> layers - this is especially the case where the continuous layers of film material 313b, 314b are formed from the same material as the first and second layers <NUM>, <NUM>, e.g. when they are all EVA. This process generates a series of sealed ostomy pouches <NUM> in the advancing sheets. In this embodiment, the stamping machine only welds around the perimeter of the pouches, leaving a cavity within the pouch <NUM>.

In this embodiment, the advancing sheets then enter the cutting machine <NUM>. The cutting machine cuts around the perimeter of the sealed weld line <NUM> created by the stamping machine <NUM>. This frees each ostomy pouch <NUM> from the advancing sheets where they can be collected or further prepared. Welding and cutting could of course take place simultaneously.

In other embodiments, additional layers of material may be introduced. In one embodiment, a fifth sheet of comfort layer material is used (not shown) and is applied on the same side of the pouch as the third <NUM> sheet. This allows the front comfort layer to be comprised of an upper part 6a and lower part 6b or 6bi as described in relation to <FIG> above, where for example, the third layer forms the lower part and the fifth layer forms the upper part. Advantageously, the third <NUM> and fifth sheets can be welded to the pouch simultaneously with the other layers, forming the pouch with an overlapping region <NUM> in a single stamp welding process.

Claim 1:
An ostomy pouch (<NUM>) comprising a cavity for storing stomal output;
the cavity defined by a rear wall (<NUM>) and a front wall (<NUM>) joined at their peripheries and formed of flexible sheet material;
the ostomy pouch (<NUM>) further comprising a sheet of woven comfort material (<NUM>) covering the outside surface of the front wall (<NUM>);
the sheet of comfort material (<NUM>) having an outside surface and an opposite inside surface, wherein the outside surface of the sheet of comfort material (<NUM>) forms at least part of the outside surface of the pouch (<NUM>), and wherein the inside surface of the sheet of comfort material (<NUM>) is laminated across its entire surface to a continuous layer of film material, with no intervening adhesive;
the continuous layer of film material having no voids; and
at least part of the continuous layer of film material being adjacent, facing and unbonded to the outside surface of the front wall (<NUM>).