Ostomy pouch

Abstract

An ostomy pouch comprising a cavity for containing stoma output. The cavity is defined by a rear wall and a front wall joined at their peripheries and formed of a flexible sheet material. The ostomy pouch further comprises a sheet of woven comfort material covering the outer surface of the front wall. The sheet of comfort material has an outer surface and an opposite inner surface, the outer surface of the sheet of comfort material forming at least a portion of the outer surface of the pouch. The inner surface of the sheet of comfort material is laminated over its entire surface to a continuous layer of film material. At least a portion of the continuous layer of film material is adjacent, facing, and not adhered to the outer surface of the front wall.

Description

[Technical Field]

[0001] The present invention relates to an ostomy pouch for managing drainage from a stoma. [Background technology]

[0002] Ostomy pouches come in a variety of forms, including closed, one-piece, and two-piece. Pouches can have a variety of shapes and components. Typically, a pouch contains a cavity formed from a (usually plastic) film, often formed by welding two layers, a front and a back, around its periphery, with the back layer of film (closest to the ostomate's body in use) containing an opening to allow drainage fluid to enter the pouch.

[0003] For the comfort of the ostomate, a "comfort layer" may be provided on the rear film layer, and usually also on the front film layer. The comfort layer is made of a material that is more comfortable against the skin than the film. The comfort layer is usually a nonwoven material, chosen for its cost or ease of assembly characteristics, for example, because it can be easily attached to the film layer of the pouch by a welding process in which the film layers are bonded to each other around their peripheries.

[0004] Recently, however, in an effort to make ostomate pouches less "medical" looking and more attractive to users, woven materials have been introduced as comfort materials for the Saltz® Confidence Bee® product, which is described in advertising materials as "stylish." The woven materials are more likely to cause others who notice the pouch to mistake it for underwear rather than a medical device.

[0005] While desirable, manufacturing an ostomy pouch with a woven comfort layer can be complex. The Saltz® Confidence Bee® product appears to include a complete layer of specially selected film material adjacent to the woven fabric layer. Thus, in one embodiment, moving outward from the ostomate, there is a posterior woven comfort layer, an opaque posterior wall defining one side of the cavity, a transparent anterior wall defining the other side of the cavity, an opaque intervening wall, and a posterior woven comfort layer. The posterior comfort layer has two overlapping sections, a top and a bottom, separated by a divider, allowing the comfort layer to be pulled apart at the divider to allow inspection of the contents through the transparent wall. The intervening layer similarly has two sections bonded (only) to the periphery of the two comfort layer sections. In this example, the intervening wall appears to prevent fraying of the comfort layer edges, preventing the contents from being visible, or to aid in the workability of the (slightly stretchy) fabric to which it is bonded.

[0006] This additional wall has a number of drawbacks for the pouch, including increased construction complexity, increased cost, increased volume, and the presence of yet another (separate) layer which can create scraping noises, making the pouch noisier in use and more noticeable.

[0007] Other prior art documents have also proposed the use of textile materials as an option for the comfort layer. For example, U.S. Patent Application Publication No. 2005 / 0273064 discloses a pouch in which the cavity-forming walls of the pouch are effectively integrated with the comfort layer. Thus, a laminate is proposed that includes a textile layer, which may be a knitted, woven, or nonwoven fabric, adhered to a film layer by a layer of adhesive that substantially continuously bonds the textile layer to the film layer. While this arrangement requires fewer layers than Saltz's Confidence Bee product, it suffers from the drawback that, for example, typical comfort layers include areas that are not adhered to the cavity-forming film layer, allowing the comfort layer to be pulled back to inspect the interior, whereas the pouch of U.S. Patent Application Publication No. 2005 / 0273064 does not allow this, since the comfort layer is substantially continuously adhered to the pouch wall.

[0008] WO 2021 / 064409 refers to a comfort layer comprising at least one textile layer and at least one film layer, optionally laminated to the at least one textile layer over the entire area of ​​the at least one textile layer. There is no mention of which side of the textile layer the film layer should be on, or any details of the laminate. When trying to implement this aspect of the invention, one skilled in the art would expect to use an intervening adhesive layer between the film and the textile, similar to the laminate of US 2005 / 0273064.

[0009] Against this background, PCT / GB2021 / 051340 proposes an ostomy pouch comprising a cavity for containing stoma waste, the cavity being defined by a rear wall and a front wall joined at their periphery and typically formed of a flexible sheet material. In this ostomy pouch, a sheet of woven comfort material covers the outer surface of the front wall and carries a web of EVA hot melt adhesive on the inner surface of the comfort material. Except for the periphery where the comfort material is adhered to the front wall, at least a portion of the web of EVA hot melt adhesive is adjacent, facing and not adhered to the outer surface of the front wall.

[0010] In PCT / GB2021 / 051340, the web of hot melt adhesive, which comprises a mass and a plurality of voids within the mass, is considered to have advantages over a "full film" in that it avoids the scraping noise associated with films and requires less material than a full film.

[0011] However, when using a web of EVA hot melt adhesive as disclosed in PCT / GB2021 / 051340, a drawback has been identified in that when the EVA coated comfort material is attached to the cavity wall at the periphery (P) of the pouch (by plastic welding), the hot melt adhesive leaks through the comfort material, causing dark spots (S) that make the pouch edge unattractive, as shown in Figure 9.

[0012] It is an aim of embodiments of the present invention to at least partially overcome or mitigate the above problems. Summary of the Invention

[0013] As used herein, the term "stomal output" refers to any gas, liquid, or solid produced by an ostomate that can be secreted from or exits the stoma. Stoma output may comprise stoma gas, stoma fluid, and stoma solids.

[0014] The term "stoma" refers to an opening in the body. Generally, a stoma is a surgical opening in the body torso. The term "stoma" may also refer to internal tissues, organs, and portions thereof exposed by the opening. In non-limiting examples, the internal tissue may be selected from the colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be an end or loop of the small intestine or large intestine.

[0015] As used herein, the term "ostomate" refers to a subject who uses an ostomy pouch disclosed herein. An ostomate typically refers to a subject who has a surgical opening, but as used herein, "ostomate" can also refer to a subject who has a stoma, whether the stoma is created by surgery or other means.

[0016] The term "user" may refer to the ostomate or a person assisting the ostomate, for example, emptying stoma waste from the cavity.

[0017] As used herein, the ostomy pouches disclosed herein may be used to manage a stoma created by, for example, an esophagostomy, gastrostomy, cholecystostomy, choledochostomy, cecostomy, colostomy, duodenostomy, ileostomy, jejunostomy, appendixostomy, tracheostomy, urostomy, nephrostomy, ureterostomy, or cystostomy. The ostomy pouches disclosed herein may be used with additional devices, including, but not limited to, shunts, catheters, plugs, or fecal management systems.

[0018] Advantageously, the ostomy pouches of the present disclosure may enable ostomates to increase the duration of use of each ostomy pouch compared to prior art pouches. This may be achieved, for example, by providing an increased cavity volume of the ostomy pouch while maintaining the care and comfort of the ostomate. Additionally or alternatively, this may be achieved by providing a means for reliably and hygienically venting stoma waste from the cavity, so as to increase the confidence of ostomates in reusing ostomy pouches compared to some prior art pouches. Because ostomates tend to use each ostomy pouch of the present disclosure for longer periods of time, the total number of ostomy pouches used by ostomates in a given period of time may be reduced. This may have environmental benefits, such as reducing the amount of environmental waste generated.

[0019] In this specification, the location and orientation of features may be described with reference to an ostomy pouch "in use" or "oriented as it would be in use," etc. Such terms refer to the intended orientation of the ostomy pouch when attached to an upright ostomate's body, regardless of whether the ostomy pouch is currently performing such use or the ostomate's actual position. The terms "upper" and "lower," and related terms, refer to the relative positions of a portion or portions of the ostomy pouch when oriented in use. For example, one section of the ostomy pouch may be referred to as the "upper" section of the ostomy pouch. In such an example, the section is intended to be the uppermost (vertically) section of the ostomy pouch when attached to an upright ostomate's body. However, as will be appreciated by those skilled in the art, this section may not always be the uppermost section before attachment to the ostomate, and even once attached to the ostomate, this section may not always be the uppermost section when the ostomate is in a non-upright position, such as lying down.

[0020] The terms "left-hand" and "right-hand" and related terms refer to the ostomy pouch when viewed from the rear (e.g., as shown in FIG. 1). Thus, as an illustrative example, in a situation where the ostomy pouch is attached to the front of the ostomate's torso, the "left" edge of the ostomy pouch faces the ostomate's left side.

[0021] The terms "concave" and "convex" and related terms refer to the shape of features of an ostomy pouch when viewed from the outside of the pouch. Thus, as an illustrative example, a circular ostomy wafer would be considered to have a convex periphery.

[0022] As used herein, the terms "front" and "rear" refer to the relative location of a portion or portions of an ostomy pouch with reference to the ostomate's body when the ostomy pouch is attached to the body. "Rear" refers to a position that is relatively closer to the ostomate's body than a comparable position that is "front." "Front" refers to a position that is relatively farther from the ostomate's body than a comparable position that is "outside."

[0023] As used herein, the term "smoothly blends" and related terms refer to the smooth merging of two edges, lines, or contours without abrupt changes in contour.

[0024] As used herein, the term "peripheral region" refers to a portion located at or towards the edge of the referenced item.

[0025] As used herein, the term "turned up" may include folding or rolling up a component.

[0026] Ostomy pouches are typically attached to the body by an ostomy wafer containing one or more adhesive layers. Ostomy wafers typically have an opening for the stoma, sometimes called a starter hole, which may be cut to the required size by the user prior to attachment. Ostomy wafers typically have an adhesive layer on the body-facing side to adhere the ostomy wafer to the ostomate's body. The body-facing side of the ostomy wafer is typically covered with a release liner, which is removed by the user before application to the skin. As used herein, the term "ostomy wafer" may be used interchangeably with the terms "adapter," "wafer," "baseplate," or "layered adhesive wafer." As used herein, the term "ostomy wafer" includes ostomy wafers for "two-piece pouch" and "one-piece pouch" applications.

[0027] As used herein, a "two-piece pouch" refers to an ostomy pouch in which the ostomy wafer forms part of a separate, body-attached component that is attached to the remainder of the pouch by a releasable bond. Two-piece pouches allow the body-attached component to be separated from the pouch without damage, so that at least one of the components remains functionally usable. For example, the body-attached component can remain in place on the ostomate's body.

[0028] As used herein, "one-piece pouch" refers to an ostomy pouch in which the ostomy wafer is permanently attached to the pouch to the extent that the ostomy wafer cannot be easily separated without risking damage to the pouch. One-piece pouches are intended to be used as an integral unit.

[0029] Ostomy pouches may generally be configured as closed pouches or open pouches. As used herein, a "closed pouch" refers to a pouch in which stoma waste is not intended to be discharged from the cavity. Thus, a closed pouch may generally be configured as a single-use, disposable, non-reusable pouch. As used herein, an "open pouch" refers to a pouch in which stoma waste is intended to be discharged from the cavity. Thus, an open pouch may be configured as a reusable pouch, and may be reused and emptied multiple times while attached to the body, although this is not required. In an open pouch, stoma waste may be discharged intermittently, as caused by the ostomate's actions, or intermittently or continuously due to the cavity being fluidly connected to a drain, e.g., a night drain line.

[0030] The present invention provides an ostomy pouch. In particular, the present invention provides an ostomy pouch having a sheet of comfort material laminated over its inner surface with a layer of film material. At least a portion of the inner surface may be adjacent to, facing, and unadhered to a cavity for accommodating stoma waste. The cavity may be defined by a rear wall and a front wall, which may be joined at their peripheries and may be formed of a flexible sheet material. The comfort material may be a woven fabric. The sheet of comfort material may cover the outer surface of the front wall. The sheet of comfort material may have an outer surface and an opposing inner surface. The outer surface of the sheet of comfort material may form at least a portion of the outer surface of the pouch. The inner surface of the sheet of comfort material may be laminated over its entire surface to a layer of film material. The layer of film material may be a continuous layer of film material. At least a portion of the continuous layer of film material may be adjacent to, facing, and unadhered to the outer surface of the front wall.

[0031] According to a broad aspect of the present invention, there is provided an ostomy pouch including a cavity for containing stoma waste, the cavity being defined by a rear wall and a front wall joined at their peripheries and formed of a flexible sheet material, the ostomy pouch further including a sheet of comfort material covering an outer surface of the front wall, the sheet of comfort material having an outer surface and an opposite inner surface, the outer surface of the sheet of comfort material forming at least a portion of the outer surface of the pouch, the inner surface of the sheet of comfort material being laminated over its entire surface to a continuous layer of film material, at least a portion of the continuous layer of film material being adjacent, facing, and unadhered to the outer surface of the front wall. The comfort material may be a woven material. The continuous layer of film material may be laminated to the comfort material without an intervening adhesive.

[0032] According to a first aspect of the present invention, there is provided an ostomy pouch comprising a cavity for containing stoma output, the cavity being defined by rear and front walls joined around their peripheries and formed of a flexible sheet material, the ostomy pouch further comprising a sheet of woven comfort material covering an outer surface of the front wall, the sheet of comfort material having an outer surface and an opposite inner surface, the outer surface of the sheet of comfort material forming at least a part of the outer surface of the pouch, the inner surface of the sheet of comfort material being laminated over its entire surface to a continuous layer of film material without intervening adhesive, at least a part of the continuous layer of film material adjacent, facing and not adhered to the outer surface of the front wall.

[0033] A continuous layer of film material may be understood to mean an uninterrupted layer, and in contrast to PCT / GB2021 / 051340, a "solid" layer without voids.

[0034] Forming webs, meshes, nets, or the like typically requires spray coating techniques (spraying or spraying a layer onto the comfort material, forming it into a roll, and laminating it to the comfort material (as disclosed in PCT / GB2021 / 051340)), so the layer of such film material must not have the properties to leak through the woven material when the comfort material is fused to the cavity wall. Thus, to be spray-coated, the inventors understand that the EVA hot melt adhesive must necessarily have a relatively low viscosity or other properties that cause problems with leakage through the comfort material. Without being bound by theory, the inventors believe that a material with a high viscosity will make the comfort material less likely to flow and be easier to manufacture as a continuous film. Therefore, in light of the present disclosure, one skilled in the art can easily select a continuous film with appropriate properties to avoid this problem.

[0035] Clearly, compared to Saltz®'s Confidence Bee® product, the ostomy pouch of the first aspect of the present invention has advantages such as no separate intervening layer and therefore less scraping noise. Furthermore, the film layer is laminated to the woven comfort material without an intervening adhesive layer, simplifying the process of attaching the comfort layer to the cavity; an already laminated woven layer can be attached directly to the film that forms the cavity, thereby reducing the number of rolls of material that need to be joined in the manufacturing process.

[0036] Compared with the specification of US Patent Application Publication No. 2005 / 0273064, the advantages are naturally almost the same as those in PCT / GB2021 / 051340.

[0037] The continuous layer of film material may have a uniform thickness (i.e., a substantially uniform thickness) across the entire surface of the sheet of woven comfort material. The thickness variation across the entire surface of the film material may be less than 10 microns, preferably less than 5 microns, more preferably less than 3 microns, for example less than 2 microns.

[0038] The continuous layer of film material may have a thickness (i.e., average thickness) of less than 60 microns (preferably less than 40 microns, more preferably less than 30 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 10 microns (preferably greater than 15 microns, more preferably greater than 20 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 20 microns and 30 microns, e.g., between 23 microns and 27 microns, e.g., about 23 microns across the entire surface of the sheet of woven comfort material.

[0039] The continuous layer of film material must be at least 0.5 g / m 2 , 1g / m 2 , 5g / m 2 , 10g / m 2 , 15g / m 2 , 16g / m 2 , or 20 g / m 2 and / or have an areal density of 500 g / m 2 , 100g / m 2 , 50g / m 2 , 40g / m 2 , 35g / m 2 , 30g / m 2 or 25 g / m 2 It may have an areal density of less than 10 g / m 2 from 50g / m 2 , 16g / m 2 from 35g / m 2 , 18g / m 2 from 30g / m 2 or 20 g / m 2 from 25 g / m 2 , e.g., 23 g / m 2 may have an areal density of

[0040] Thus, in one preferred embodiment there is provided an ostomy pouch comprising a cavity for storing stoma waste, the cavity being defined by rear and front walls joined at their peripheries and formed of a flexible sheet material, the ostomy pouch further comprising a woven sheet of comfort material covering an outer surface of the front wall, the sheet of comfort material having an outer surface and an opposite inner surface, the outer surface of the sheet of comfort material forming at least a portion of the outer surface of the pouch, the inner surface of the sheet of comfort material being laminated over its entire surface to a continuous layer of film material without an intervening adhesive, at least a portion of the continuous layer of film material adjacent, facing and not adhered to the outer surface of the front wall, the continuous layer of film material having a woven weight of 18 g / m 2 from 30g / m 2 has an areal density of

[0041] The continuous layer of film material is formed of a material that will adhere to the material of the comfort layer without the need for an intervening adhesive, and thus the continuous layer of film material may be a continuous layer of hot melt adhesive material.

[0042] The continuous layer of film material may be formed from the same material as the front and rear walls, which improves attachment of the comfort material to the cavity since the two materials typically melt at the same temperature in a plastic welding process and adhere well to each other.

[0043] The continuous layer of film material and the front and rear walls may be formed of polymers having the same chemical structure. n The continuous layer of film material and the front and rear walls may be formed of a polymer having the same melting point M p The continuous layer of film material and the front and rear walls may be formed of polymers obtained from the same source and having the same name. By using polymers obtained from the same source and having the same name, other characteristics that define similarity (e.g., structure, M n , M p ) should be guaranteed to be the same without the need for measurement.

[0044] The continuous layer of film material is preferably formed from EVA, although it may alternatively be formed from other plastic materials, such as polyethylene, provided that the film is selected to have suitable properties in terms of being able to adhere to the comfort material without an intervening adhesive layer and without leaking.

[0045] The pouch may have a front side and a rear side. A sheet of woven comfort material may form at least a portion of the front side of the pouch. The front and rear sides of the pouch may both be formed from the sheet of woven comfort material. Thus, the ostomy pouch may further comprise a sheet of woven comfort material covering an outer surface of the rear wall, the sheet of comfort material having an outer surface and an opposite inner surface, the outer surface of the sheet of comfort material forming at least a portion of the outer surface of the pouch, the inner surface of the sheet of comfort material being laminated over its entire surface to a continuous layer of film material, at least a portion of the continuous layer of film material adjacent, facing, and not adhered to the outer surface of the rear wall.

[0046] Thus, such an embodiment of the present invention provides a pouch that is covered on both sides (front and back) with a woven comfort material that provides increased comfort to the user, and that has a continuous layer of film material laminated to the sheet of comfort material such that the pouch can be easily manufactured without additional welding steps or the introduction of intermediate layers and without adhesive leaking through the comfort layer. In effect, the laminated sheet of comfort material can be bonded to the remainder of the pouch, e.g., the front wall defining one side of the cavity and the back wall defining the other side of the cavity, in the same manner that a nonwoven fabric is bonded (usually in a single welding step in which the peripheral edges of all layers are bonded together).

[0047] The woven comfort material may comprise any one or more of natural materials, such as cotton or wool, and / or synthetic materials, such as polyester, nylon, viscose, polyethylene, or polypropylene. The woven material may be woven with a density of 20 g / m 2from 200 g / m 2 , preferably 40 g / m 2 from 80g / m 2 , e.g. 58g / m 2 The woven material may have an areal density of 200N to 400N, preferably 250N to 350N, e.g., 300N for the warp and 280N for the weft. The woven material may have a tear strength of 5N to 50N, preferably 10N to 30N, e.g., 18N. The woven material may have a colorfastness rating of 4 to 5 against one or more of rubbing, perspiration, and washing (40°C). The woven material may have a durability of 50,000 or more abrasion tests. The woven material may be waterproof. For example, the woven material may comprise woven polyester with a water-repellent finish. The water-repellent finish may be fluorocarbon-based. The water-repellent finish may be dye-heatset or boil-off heatset.

[0048] The woven comfort layer may have a thickness of from 50 micrometers to 1000 micrometers, preferably from 60 micrometers to 500 micrometers, more preferably from 75 micrometers to 300 micrometers.

[0049] The rear wall and the front wall may have substantially the same shape. The rear wall and the front wall may be formed of a plastic film. The rear wall and / or the front wall may be opaque. The rear wall and / or the front wall may be transparent. In particular, at least a portion of the front wall may be transparent. The rear wall and / or the front wall may be formed of, for example, any one of polyurethane, polyethylene (PE), polyvinylidene chloride (PVDC), or ethylene vinyl acetate (EVA). The rear wall and / or the front wall may each have a thickness of 50 μm to 150 μm. The rear wall and / or the front wall may each have a thickness of 75 μm to 100 μm. The rear wall and the front wall may have corresponding inner and outer surfaces. The inner surfaces of the rear wall and the front wall may form the interior of the cavity. The outer surfaces of the rear wall and the front wall may form the exterior of the cavity. The sheet of woven comfort material may have substantially the same shape as the front wall. The sheet of comfort material may be adhered to the exterior surface of the cavity wall at its periphery and free from adhesion to the wall other than at the periphery.

[0050] The sheet of woven comfort material covering the front side of the pouch may comprise one or more sections. The sheet of woven comfort material covering the front side of the pouch may comprise an upper section and a lower section. The upper and lower sections, when joined together, may have the same shape as the front wall. The upper section may extend from the upper end of the pouch to a position 20% to 50% of the length below the upper end. The lower section may extend from the lower end of the pouch to a position 15% to 50% of the length below the upper end. An overlapping region may be provided where the upper and lower sections overlap. The upper section may extend over the lower section (or vice versa), forming an overlap at the overlapping region. The upper and lower sections may be separable from each other at the overlapping region. The overlapping region may extend horizontally when the ostomy pouch is in use. Thus, particularly when the front wall is formed of a transparent film, the present invention provides a device that allows convenient observation of the stoma and / or the contents of the pouch, as needed.

[0051] The pouch may include a drain. The drain may be located 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 configuration and an unfolded configuration. The drain may be in a closed state in the folded configuration. The drain may be in an open state in the unfolded configuration. When the drain is open, the drain may allow stomal waste to exit the cavity of the pouch. When the drain is closed, the drain may prevent stomal waste from exiting the cavity of the pouch.

[0052] The drain may include one or more purging strips. Each purging strip may span the width of the drain. Each purging strip may extend the same distance along the length of the drain. Each purging strip may provide localized stiffness to the drain. Each purging strip may be formed from polystyrene. Each purging strip may define the location and orientation of one or more folds in the drain. Each purging strip may include a strip of flexible material attached to the drain. The strip may have a higher stiffness than the material of the drain. Each purging strip may have a degree of resilience once attached to the drain. Thus, the purging strip may be compressed laterally to cause the purging strip to arch, thereby assisting in opening the drain.

[0053] The purging strip may be provided on the rear wall. The purging strip may be provided adjacent to the lower end of the drain. The purging strip may be provided on an outer surface of the rear wall. The purging strip may be provided on the front wall. The purging strip on the front wall may be provided on the outer surface of the front wall. The purging strip on the front wall may be provided above the purging strip on the rear wall. The purging strip on the front wall may be provided midway between the upper and lower ends of the drain. A longitudinal gap may be provided between an upper edge of the purging strip on the rear wall and a lower edge of the purging strip on the front wall. The longitudinal gap may define the position of a first fold of the drain.

[0054] A fastening element may be disposed on an outer surface of the rear wall. The rear fastening element may be disposed above the front purging strip. A longitudinal gap may be provided between an upper edge of the purging strip on the front wall and a lower edge of the second fastening element. The longitudinal gap may define a position of a fold in the drain. The rear fastening element may be disposed adjacent to an upper end of the drain.

[0055] A closure mechanism for a drain of an ostomy pouch may be attached to a sheet of comfort material covering the front of the pouch. The closure mechanism may be attached to an outer 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 outer surface and an inner surface. The inner surface of the closure flap may be adjacent to the outer surface of the comfort material. The closure mechanism may include a front fastening element. The front fastening element may cooperate with a rear fastening element to fasten. Tightening the fastening member may close the drain.

[0056] The closure flap may comprise a woven comfort material (optionally comprising a continuous layer of film material), which is desirable as forming the closure flap from the same material as the comfort material makes it more subtle / discreet.

[0057] The front fastening element may be positioned above the rear fastening element. The front fastening element may be positioned adjacent to a lower 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 a position for a fold of the drain. The rear fastening element may be positioned adjacent to an upper edge of the drain.

[0058] The drain may be closed by repeatedly folding the drain upward around creases defined by the front and rear pursing strips and the front and rear fastening elements. The folded drain may be held between a woven comfort material and a closure flap. The sides of the closure flap may not extend beyond the edges of the comfort material. The closure flap may include 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.

[0059] The drain can thus be conveniently closed against the comfort material and secured in place by the closure flap, thus eliminating the need to fold or secure the drain under the comfort material, making the pouch easier to use. The provision of tabs facilitates deployment of the drain by allowing access to lift the closure flap to release the fastening elements, as well as including fastening elements that do not span the entire width of the drain.

[0060] According to a second aspect of the present invention, there is provided a method of forming a comfort layer laminate for adhering to a cavity of an ostomy pouch, the method comprising laminating a continuous layer of film material directly to a sheet of comfort material without an intervening adhesive layer.

[0061] Preferably, a continuous layer of film material is laminated to the sheet of comfort material under conditions of elevated temperature (above ambient temperature) and pressure, for example by calendering.

[0062] Of course, the comfort layer and film material may have any of the characteristics outlined above, such as the described materials and / or a maximum thickness that would make the layer of film material suitable as a backing for the comfort layer and would be easily adaptable, but not suitable for forming the wall of the cavity.

[0063] Thus, for example, in one embodiment, the layer of comfort material is woven. There is thus provided a method of forming a comfort layer laminate for adhering 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 without an intervening adhesive layer.

[0064] Of course, the method should form the material such that the layer of comfort material remains continuous, i.e., no step in the method should introduce voids or openings. Thus, in one embodiment, there is provided a method of forming a comfort layer laminate for adhering to a cavity of an ostomy pouch, the method comprising laminating a continuous layer of film material directly to a sheet of comfort material, without an intervening adhesive layer, to form a woven sheet of comfort material having an outer surface and an opposite inner surface, the inner surface of the sheet of comfort material being laminated over its entire surface to the continuous layer of film material, without an intervening adhesive, and the continuous layer of film material being an uninterrupted "solid" layer with no voids.

[0065] According to a third aspect of the present invention there is provided a method of forming an ostomy pouch, the method comprising providing a sheet of comfort material having a continuous layer of film material laminated over an entire first surface thereof, and adhering only a portion of the first surface of the sheet of comfort material to an outer surface of a wall of a cavity of the ostomy pouch, whereby at least a portion of the continuous layer of film material is adjacent, facing and not adhered to the outer surface of the front wall.

[0066] A sheet of comfort material having a continuous layer of film material laminated over a first surface thereof is preferably formed according to the second aspect of the invention.

[0067] Thus, a preferred method of forming an ostomy pouch includes first forming a comfort layer laminate for application to the cavity of the ostomy pouch by laminating a continuous layer of film material directly to a sheet of comfort material without an intervening adhesive layer to provide a sheet of comfort material having a continuous layer of film material laminated across an entire first surface thereof, and then adhering only a portion of the first surface of the sheet of comfort material to the exterior surface of the wall of the ostomy pouch cavity to form the ostomy pouch, whereby at least a portion of the continuous layer of film material is adjacent, facing, and not adhered to the exterior surface of the front wall.

[0068] The step of laminating the continuous layer of film material directly to the sheet of comfort material may be performed separately from the step of adhering the inner surface of the woven comfort material sheet to the pouch wall. For example, it may be performed temporally separately, e.g., at least 5 minutes, 10 minutes, 1 hour, 12 hours, or 24 hours, before adhering the inner surface of the comfort material sheet to the wall. Alternatively / additionally, the step of laminating the continuous layer of film material directly to the sheet of comfort material may be performed physically separate from the step of adhering the inner surface of the woven comfort material sheet to the pouch wall. For example, it may be performed in a different room, a different building, or in a different city, county, or state.

[0069] Thus, 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 the ostomy pouch, the method comprising laminating a continuous layer of film material directly to a sheet of comfort material, without an intervening adhesive layer, to provide a sheet of comfort material having a continuous layer of film material laminated across an entire first surface, and then forming the ostomy pouch by adhering only a portion of the first surface of the sheet of comfort material to an outer surface of a wall of the cavity of the ostomy pouch, whereby at least a portion of the continuous layer of film material is adjacent to, facing, and not adhered to the outer surface of the front wall, and wherein the step of laminating the continuous layer of film material directly to the sheet of comfort material is performed separately in time from the step of adhering the inner surface of the sheet of woven comfort material to the wall of the pouch at least 12 hours before adhering the inner surface of the sheet of comfort material to the wall.

[0070] Preferably the method comprises adhering a 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 adhering is welding.

[0071] Preferably, the cavity is defined by rear and front walls joined at their periphery and formed of a flexible sheet material. The method may comprise providing rear and front walls formed of a flexible sheet material and joining the rear and front walls at their periphery. The method may include adhering an inner surface of a sheet of comfort material at its periphery to one or more of the rear and / or front walls of the ostomy pouch. The method may include simultaneously joining the front and rear walls of the cavity and adhering a portion of a first surface (inner surface) of the sheet of comfort material to at least one of the walls of the cavity.

[0072] The sheet of comfort material may comprise two or more sections, and the method may include arranging the sections of the sheet of comfort material and adhering the sections of the sheet of comfort material to the pouch. Adhering of the sections of the sheet of comfort material may be performed simultaneously. Adhering may be performed by welding. Thus, the present invention allows for complex arrangements of materials to be applied to the pouch in a single manufacturing step, reducing manufacturing complexity and cost.

[0073] According to a fourth aspect of the present invention there is provided an ostomy pouch formed by the method of the third aspect of the present invention. Again, of course the ostomy pouch may be an ostomy pouch according to the broad aspect or the first aspect above and may have any of the features defined above.

[0074] According to a fifth aspect of the present invention, there is provided a method of collecting stoma output using an ostomy pouch according to any aspect described herein. The method may comprise attaching the ostomy pouch to an ostomate's stoma. If the pouch comprises a one-piece ostomy pouch, the ostomy pouch may be attached to the stoma using an ostomy wafer of the pouch. Alternatively, the method may comprise attaching an ostomy wafer of a body-worn component of a two-piece ostomy pouch to the stoma and attaching the pouch to the body-worn component. The pouch may be attached to the body-worn component before or after the ostomy wafer is attached to the stoma. If the ostomy pouch comprises an open pouch or an open pouch, the method may include draining stoma output from the ostomy pouch.

[0075] Again, the fifth aspect of the invention may include any feature associated with any of the first to fourth aspects of the invention.

[0076] 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, in which: [Brief explanation of the drawings]

[0077] [Figure 1] FIG. 1 is a rear view of an ostomy pouch. [Figure 2] FIG. 2 is a front view of the ostomy pouch of FIG. [Figure 3] FIG. 3 is a cross-sectional side view of the ostomy pouch of FIG. [Figure 4] FIG. 4 is a front view of an alternative ostomy pouch. [Figure 5] FIG. 5 is a cross-sectional side view of the ostomy pouch of FIG. [Figure 6] FIG. 6 is an exploded perspective view of the ostomy pouch of FIG. [Figure 7] FIG. 7 is a side view of an apparatus for manufacturing ostomy pouches. [Figure 8] FIG. 8 is a partial view of an ostomy pouch according to any of the embodiments of FIGS. 1 to 8, showing no leakage of the laminated film layer through the woven comfort material in the area where the comfort material is adhered to the cavity. [Figure 9] FIG. 9 is a partial view of an ostomy pouch having a layer of comfort material manufactured according to a prior art method, showing hot melt adhesive leaking through the woven comfort material in the area where the comfort material is adhered to the cavity. DETAILED DESCRIPTION OF THE INVENTION

[0078] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the claimed subject matter belongs. It should be understood that the foregoing summary of the disclosure and the following examples are exemplary and explanatory and are not intended to limit any of the claimed subject matter.

[0079] The following description is directed to embodiments of the present disclosure. The description of the embodiments is not intended to include all possible embodiments of the present disclosure as set forth in the appended claims. Many variations, modifications, and equivalents not expressly described 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.

[0080] As used herein, 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 specifically stated otherwise. Furthermore, the use of the term "including," as well as other forms such as "include," "includes," "included," etc., is not limiting.

[0081] As used herein, ranges and amounts may be expressed by adding "about" to a particular value or range. "About" includes the exact amount. For example, "about 5 mm" means "about 5 mm" and "5 mm." In general, the term "about" includes amounts that are expected to be within experimental error. The term "about" includes values ​​less than 5% to greater than 5% of the provided value. For example, "about 30 mm" means "between 28.5 mm and 31.5 mm."

[0082] 1 to 3, there is shown an embodiment of the present invention in which an ostomy pouch 1 comprises a rear wall 2, a front wall 3, a separation wall 4, a rear comfort layer 5, a front comfort layer 6, and an ostomy wafer 7. In other embodiments within the scope of the claimed invention, one or more of the separation wall 4, rear comfort layer 5, and front comfort layer 6 may be omitted if desired.

[0083] In this embodiment, the ostomy pouch 1 is a one-piece pouch, and the ostomy wafer 7 is permanently attached (in the sense that it cannot be easily removed and reattached without damaging the pouch) to the ostomy pouch 1. However, other embodiments may be two-piece pouches, comprising a pouch component and a body-attached component, which together form the ostomy pouch. In some of these embodiments, the pouch comprises a rear wall 2, a front wall 3, a separation wall 4, a rear comfort layer 5, and a front comfort layer 6, and the body-attached component comprises the ostomy wafer 7.

[0084] The rear wall 2 and the front wall 3 define a cavity for containing stoma output. In this embodiment, both the rear wall 2 and the front wall 3 are formed of flexible sheet material in the form of a plastic film and are joined together to define the cavity. An exemplary film is ethylene vinyl acetate (EVA). The film typically has a thickness of 75 μm to 100 μm, but in some embodiments may have a thickness of 50 μm to 150 μm.

[0085] In this embodiment, the ostomy pouch 1 has an upper section 10, a lower section 11, and a waist section 12 located between the upper section 10 and the lower section 11. The upper section 10 has a maximum width A, the lower section 11 has a maximum width B, and the waist section 12 has a minimum width C. In this embodiment, the maximum width A of the upper section 10 is greater than the maximum width B of the lower section 11, and the maximum width B of the lower section 11 is greater than the minimum width C of the waist section 12.

[0086] In this embodiment, the ostomy pouch 1, when viewed from the back, has a left edge 13 and a right edge 14. The waist section 12 has a left edge 13c and a right edge 14c, both of which are smoothly rounded and merge with the left edges 13a, 13b and right edges 14a, 14b of the upper section 10 and the lower section 11, respectively.

[0087] The shape and dimensions of the ostomy pouch 1 are not particularly limited, so long as they remain unobtrusive and comfortable to wear when in use. Exemplary dimensions and other suitable shapes are described in the prior art documents cited in the introduction, such as PCT / GB2021 / 051340, which is incorporated by reference.

[0088] In this embodiment, the left and right edges 13c, 14c of the waist portion 12 have a concave curvature with a radius of curvature r1.

[0089] In this embodiment, both the upper section 10 and the lower section 11 are rounded and include continuously curved edges 15, 16, respectively. The curved edges 15, 16 extend from the upper and lower ends of the left edge 13c of the waist section 12 to the corresponding upper and lower ends of the right edge 14c of the waist section 12. The edges 15, 16 are convexly curved with radii of curvature r2, r3, respectively. In this embodiment, r2 and r3 are constant along the corresponding edges 15, 16, respectively, but in alternative embodiments, they may be variable.

[0090] In this embodiment, upper section edge 15 incorporates left and right edges 13a, 14a of upper section 10, and lower section edge 16 incorporates corresponding left and right edges 13b, 14b of the lower section.

[0091] In this embodiment, the junction between the upper section 10 and the waist section 12 may be defined by a single inflection point 17 between edges 13a, 14a of the upper section 10 and edges 13c, 14c of the waist section 12. Similarly, the junction between the lower section 11 and the waist section 12 may be defined by a single inflection point 18 between edges 13b, 14b of the lower section 11 and edges 13c, 14c of the waist section 12.

[0092] The rear wall 2 and the front wall 3 are joined at their peripheries by welding. Welding is the preferred method of joining the rear wall 2 and the front wall 3 because it allows all layers of the pouch 1 to be joined simultaneously, as described below.

[0093] In this embodiment, the rear wall 2 and front wall 3 are joined together by a single continuous edge seal 8 that extends around the entire periphery of the rear wall 2 and front wall 3 to form a liquid tight seal.

[0094] The rear wall 2 is provided with a stoma entrance 20 for receiving stoma output into the cavity. The stoma entrance 20 is an opening cut in the rear wall 2 in the upper section 10 of the ostomy pouch 1, within which the wafer 7 is provided, the wafer having a hole through which the stoma normally extends.

[0095] In this embodiment, the rear comfort layer 5 and the front comfort layer 6 are substantially the same shape as the rear wall 2 and the front wall 3. The rear comfort layer 5 and the front comfort layer 6 form the outside of the ostomy pouch 1 and cover the rear wall 2 and the front wall 3, respectively. The rear comfort layer 5 also includes a wafer opening that aligns with the stoma entrance 20 in the rear wall 2, and into which the wafer 7 is placed.

[0096] The rear comfort layer 5 and the front comfort layer 6 are formed from flexible sheets of textile fabric laminated over their entire surfaces to a continuous layer of film material that forms an uninterrupted, solid layer with no voids, thus completely covering one surface of the comfort layer 6, i.e., the inner surface in use.

[0097] In this embodiment, the textile layers form the outer surfaces of the rear comfort layer 5 and front comfort layer 6, respectively, and continuous layers of film material are disposed on corresponding inner surfaces, facing the rear wall 2 and front wall 3. In other embodiments, additional textile and / or film layers may be included as desired. In this embodiment, the textile layer may comprise polyester, although in other embodiments, any one or more of nylon, viscose, polyethylene, and polypropylene may be used in addition to or as an alternative.

[0098] In this embodiment, the fabric layer is 58 g / m 20.01 mm, a tensile strength of 280 N to 300 N, and a tear strength of 18 N. Other embodiments have different compositions, e.g., 50 g / m 2 from 70 g / m 2 The fabric may have an areal density of 100 to 400 N, a tensile strength of 200 to 400 N, and a tear strength of 10 to 30 N. Some embodiments may have a colorfastness rating of 4 to 5 against either rubbing, sweat, or washing (at 40°C), and may have a durability of 50,000 or more cycles in the abrasion test. Particular embodiments comprise a woven polyester with a water-repellent finish. The water-repellent finish may be fluorocarbon-based and may be dye-heatset or boil-off heatset. A suitable polyester woven layer is available from Newton Textiles, Northamptonshire, UK, under the designation 75DCWR, such as 75DCWRWHITE (white version).

[0099] In this embodiment, the continuous layer of film material comprises ethylene vinyl acetate (EVA).

[0100] In this embodiment, the continuous layer of film material is 23 g / m 2 A suitable EVA film is available from Protechnique, Cernay, France, under the designation 3X9S23.

[0101] A continuous layer of film material is laminated to the textile layer over the entire area of ​​the inner surface of the rear comfort layer 5 and front comfort layer 6. A lamination process, such as calendering at high temperature and pressure, forms a laminate in which the continuous layer of film material extends to a uniform thickness and without voids over the entire area of ​​the comfort layers 5 and 6. Because the EVA film is bonded at high temperature, there is no adhesive layer between the continuous film and the comfort layers; rather, the continuous layer of film material is laminated directly to the comfort layers.

[0102] Advantageously, by providing a continuous layer of film material, both comfort layers 5, 6 and both walls 2, 3 can be simultaneously bonded to one another, if desired, in the same manner and with the same welding process as nonwoven materials, improving bonding without the need for special intervening layers or adhesives during the construction process. In this embodiment, peripheral welds defined by edge seal 8 bond the rear comfort layer 5 to the rear wall 2 and the front comfort layer 6 to the front wall 3. In other embodiments, different welds may be used as needed or desired. For example, the welds may correspond to only a portion of the welds joining the rear wall 2 and the front wall 3. The welds attaching the rear comfort layer 5 to the rear wall 2 may be different from the welds attaching the front comfort layer 6 to the front wall 3. The continuous layer of film material also protects the woven layers from undesirable fraying.

[0103] In this embodiment, the front comfort layer 6 includes an upper portion 6a and a lower portion 6b, which, when combined, conform to the shape of the front wall 3. The upper portion 6a extends from the top of the pouch 1 to an inflection point 17 between the upper section 10 and the waist section 12. The lower portion 6b extends from the bottom of the pouch 1, below the upper portion 6a, to a position slightly above the inflection point 17. Thus, the upper portion 6a partially overlaps the lower portion 6b at an overlap region 115. The upper and lower portions 6a and 6b are separable from each other at the overlap region 115, forming a window opening for viewing the cavity. The overlap region 115 extends horizontally when the ostomy pouch 1 is in use. In some embodiments, the overlap region 115 does not need to coincide with the inflection point 17 and may straddle the pouch 1 at any suitable location along the length of the pouch 1. Importantly, without the continuous layer of film material, regardless of the choice of material for the walls 2, 3, the two portions 6a, 6b of the front comfort layer 6 will not be bonded to each other at all, as the wall material will not participate in bonding in that area.

[0104] In other embodiments, the front layer may be made up of multiple parts, which may have the same shape and dimensions as the front wall 3 when the multiple parts are combined.

[0105] In this embodiment, the ostomy wafer 7 is aligned with the stoma entrance 20 in the rear wall 2 and extends through the wafer opening in the rear comfort layer 5. The ostomy wafer 7 comprises an adhesive and a release liner 31. The ostomy wafer 7 is attached to the rear wall 2 by welding. In other embodiments, the wafer 7 may be attached by any suitable alternative means (e.g., adhesive).

[0106] The ostomy pouch 1 may include a gas exhaust port for exhausting stoma gas from the cavity. In this embodiment, the ostomy pouch 1 includes a gas exhaust filter 24 that also functions as an odor filter. A suitable filter may be a charcoal or activated carbon filter to suppress unwanted odor emissions from the cavity. The gas exhaust filter 24 forms part of the gas exhaust port, which includes a gas exhaust opening 27 located in the front wall 3. In some embodiments, the gas exhaust filter 24 is covered by a filter cap, and the gas exhaust filter 24 and filter cap are positioned on the front wall 3 to cover the gas exhaust opening 27. The gas exhaust opening 27 allows gas to pass from the cavity through the gas exhaust filter 24 and the filter cap to the exterior of the ostomy pouch.

[0107] In this embodiment, the gas vent is located in the upper quarter of the ostomy pouch 1 in use. In particular, the center of the gas vent opening 27 is located above the center of the stoma entrance 20 in use. In other embodiments, the gas vent may be located elsewhere in the upper section 10 of the ostomy pouch 1.

[0108] In this embodiment, the separation wall 4 is located between the rear wall 2 and the front wall 3. The separation wall 4 comprises a separation filter 100 for filtering stoma gas and / or stoma liquid from stoma solids contained in the stoma output. The separation filter 100 thus prevents stoma solids from contacting the gas outlet and clogging or otherwise impairing the gas outlet filter 24.

[0109] In this embodiment, the separation wall 4 has the same outer shape and dimensions as the rear wall 2 and the front wall 3 and divides the cavity of the ostomy pouch 1 into a first chamber 101 and a second chamber 102. The first chamber 101 extends between the separation wall 4 and the rear wall 2, and the second chamber 102 extends between the separation wall 4 and the front wall 3. The first chamber 101 and the second chamber 102 have substantially the same volume. In other embodiments, they may have different volumes, and / or the second chamber 102 may have a larger volume than the first chamber 101.

[0110] In this embodiment, the separation wall 4 is welded to the rear wall 2 and the front wall 3 around their peripheries to form a fluid-tight seal therebetween. In another embodiment, the separation wall 4 is joined to the rear wall 2 and the front wall 3 around the entire edge of the top section 10, and additionally joined to the front wall 3 by a horizontal weld at the interface between the upper section 10 and the waist section 12. Thus, the separation wall 4 and the rear wall 2 and the front wall 3 according to some embodiments of the present invention may be joined such that the first chamber 101 and the second chamber 102 are sealed to each other other than through the separation filter 100.

[0111] In this embodiment, the separation wall 4 comprises a flexible sheet material that 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 4 has a thickness of 50 micrometers to 150 micrometers, preferably 75 micrometers to 100 micrometers. In this embodiment, the separation wall 4 comprises a water- and oil-repellent coating applied to the flexible sheet material. In other embodiments, the flexible sheet material may be water- and / or oil-repellent.

[0112] 4 to 6, a further embodiment of an ostomy pouch 201 according to the present invention is similar to the embodiment shown in Figures 1 to 3, with like features being given like reference numerals increased by 200. The main difference is that the lower section 211 of the further embodiment is shaped to accommodate / form a collapsible drain. Thus, in contrast to the above-described embodiment, the ostomy pouch 201 of this embodiment is an open pouch without a sealed periphery.

[0113] Furthermore, in this embodiment, there is no separating wall between the front wall 203 and the rear wall 202, so the cavity is not divided into two sections. The rear wall 202 has a large opening 202i aligned with the stoma entrance 207i of the wafer 207 (the wafer 207 is connected to the rear wall 202 in the area between the periphery of the opening 202i and the periphery of the wafer, so that stoma waste enters the cavity through the stoma entrance of the wafer and the opening 202i in the rear wall). The rear comfort layer 205 also has an opening 205i that is slightly larger than the opening 202i in the rear wall 202 and aligned with the opening 202i so that it is sandwiched between the outermost edge of the wafer and the rear wall 202. The stoma entrance 207i is adjustable to fit the ostomate's stoma.

[0114] As with the first embodiment, the front comfort layer 206 of this embodiment is formed from two parts: an upper part 206a and a lower part 206b. The upper part 206a overlaps the lower part 206b over most of the width of the pouch 201 at a height that aligns with the stoma opening 207i. This overlap is defined by the lower edge 231 of the upper part 206a overlapping the upper edge 232 of the lower part 206b.

[0115] In this embodiment, an optional gas filter 224 is provided, located in the front wall 203 at a level above the stoma entrance 207i to allow gases to exit the pouch 201. In this embodiment, the filter 224 is covered by an optional filter cover patch 225 (not shown in FIG. 5) on the outer surface of the front wall 203. The filter 224 and filter cover patch 225 are thus covered by the upper portion 206a of the front comfort layer 206.

[0116] In this embodiment, the lower section 211 includes a drain opening 40. The drain opening 40 is the unsealed portion of the periphery of the ostomy pouch 201 where the rear wall 202 and front wall 203 are not sealed.

[0117] In this embodiment, lower section 211 includes a rounded portion 211a and a substantially rectangular drain portion 41 that accommodates drain opening 40, with rounded portion 211a adjacent waist section 212 and drain portion 41 distal to waist section 212. Drain portion 41 is foldable along its length between an unfolded configuration and a folded configuration, as described below.

[0118] In this embodiment, lower section 211 has a continuous left edge 42 that extends from left edge 213c of waist section 212 around curved left edge 42c of generally rounded portion 211a and along left edge 42d of drain portion 41 to left apex 44 of drain opening 40. Similarly, continuous right edge 43 extends from right edge 214c of waist section 212 around continuously curved right edge 43c of generally rounded portion 211a and along right edge 43d of drain portion 41 to right apex 45 of drain opening 40. (Note that because FIG. 4 is a front view, the left edge of pouch 1 is on the right side of the figure, and the right edge of pouch 1 is on the left side of the figure.)

[0119] The left and right edges 42d, 43d of the drain portion 41 are parallel to each other along most of their length.

[0120] In this embodiment, a single continuous edge seal 208 extends around the periphery of the pouch 201 from the left apex 44 of the drain opening 40 to the right apex 45 of the drain opening 40, leaving the distal end of the drain opening 40 open.

[0121] In this embodiment, the drain portion 41 defines an elongated drain passageway extending from the cavity of the ostomy pouch 201 to a drain opening 40 located at the lower end of the drain portion 41. Because the drain portion 41 is integral with the lower section 211, the rear wall 202 and the front wall 203 may each be a single piece of material including the upper section 210, the waist section 212, and the lower section 211 (including the drain portion 41). However, in this embodiment, the rear comfort layer 205 and the front comfort layer 206 do not cover the drain portion 41 of the rear wall 202 and the front wall 203.

[0122] In this embodiment, communication between the cavity and the elongated drain passage is via a drain inlet 200 defined as the transition point between the cavity and the drain portion 41. The drain inlet 200 allows the passage of stoma waste from the cavity to the drain portion 41 when the drain portion 41 is deployed.

[0123] In this embodiment, moving the drain portion 41 between the unfolded and collapsed configurations opens and closes the drain opening 40, thereby allowing or preventing the escape of stoma waste contained in the cavity of the ostomy pouch 1.

[0124] In this embodiment, the drain portion 41 can be folded repeatedly in the same direction along its length into multiple segments having generally equal segment lengths and separated by folds. Thus, the drain portion 41 can be folded one or more times in succession so that the segments overlap one another. Each fold is formed across the width of the drain portion 41 and acts to restrict, and preferably prevent, stoma waste from exiting the drain opening 40.

[0125] In this embodiment, a first purging strip 221 and a second purging strip 222 are provided in the drain portion 41. Together, the purging strips 221, 222 provide localized stiffness to the drain portion 41 and define the position and direction of the segments and folds of the drain portion 41. The purging strips 221, 222 comprise strips of flexible material attached to the drain portion 41, and the strips 221, 222 have a stiffness greater than that of the material of the drain portion 41. Additionally, the purging strips 221, 222 have elasticity such that, once attached to the drain portion 41, the purging strips 221, 222 can be laterally compressed, causing the purging strips to become bowed, thereby opening an elongated drain passage. In other embodiments, two or more purging strips may be used.

[0126] In this embodiment, the purging strips 221, 222 are formed from polystyrene, but in other embodiments may comprise any suitable material.

[0127] In this embodiment, the first purging strip 221 is attached to the rear wall 202 of the drain section 41 adjacent the drain opening 40. The second purging strip 222 is attached to the front wall 203 of the drain section 41 above the second purging strip 221. A longitudinal gap is provided between the upper edge of the first purging strip 221 and the lower edge of the second purging strip 222. Thus, the longitudinal gap defines the location of the first fold of the drain section 41. Each purging strip 221, 222 spans the width of the drain section 41 and extends the same distance along the length of the drain section 41.

[0128] In this embodiment, the rear fastening element 215a is arranged on the rear wall 202, and the front fastening element 215b is arranged on a flap 223 attached to the front comfort layer 206. In this example of a two-piece front comfort layer 206, the flap 223 is attached to the lower part 206b of the comfort layer 206. The rear fastening element 215a and the front fastening element 215b have corresponding hook-and-loop fastener elements. The rear fastening element 215a is arranged on the drainage section 41 above the second pursing strip 222. A longitudinal gap is provided between the upper edge of the second pursing strip 222 and the lower edge of the rear fastening element 215a. Thus, the longitudinal gap defines the position of the second fold of the drainage section 41.

[0129] In this embodiment, the flap 223 comprises a first flange 223a and a second flange 223b formed in one piece. The first flange 223a spans substantially all of the width of the rounded lower section 211a, but does not extend beyond the edge seal 208 at a point one-third of the way up the length of the rounded section 211a from the drain inlet 200. The first flange 223a is attached to the comfort material 206 by a single weld that spans substantially the entire width.

[0130] The flap 223 may be formed from the same material as the comfort layer, i.e., a sheet of woven comfort material, with a continuous layer of film material laminated to its inner surface. In this manner, the weld between the outer surface of the comfort layer 206b and the flap 223 is enabled by the continuous layer of film material forming the inner 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 1 only by the first flange 223a. The second flange 223b is shaped to conform to the shape of the rounded portion 211a but is thinned to follow the inner edge of the peripheral weld 208. In this manner, the second flange 223b extends downward from the first flange 223a within the periphery defined by the edge seal 208 of the pouch 201.

[0131] In this embodiment, the flap 223 has an outer surface facing away from the ostomate during use and an opposite inner surface. The front fastening element 215b is positioned on the inner surface of the second flange 223b at a position higher than the rear fastening element 215a. A longitudinal gap is provided between the upper edge of the rear fastening element 215a and the lower edge of the front fastening element 215b, and this longitudinal gap defines the position of the third fold of the drain section 41. The flap 223 is formed from a flexible sheet material that is more rigid than the flexible sheet material of the rear wall 202, the front wall 203, and the comfort layers 205 and 206. In this embodiment, the flap 223 is formed from a plastic foam that provides the desired rigidity.

[0132] The drain portion 41 may be folded as follows: First, the distal end of the drain portion 41 is folded upward and away from the rear surface of the ostomy pouch 201 along a first fold line, positioning the first purging strip 221 above the second purging strip 222. Second, the drain portion 41 and the purging strips 221, 222 are folded again in the same orientation along a second fold line and then a third fold line, so that the folded and stacked first purging strip 221, second purging strip 222, and first fastening element 215a are positioned below the second flange 223b of the flap 223, with the rear fastening element 215a exposed and adjacent to the front fastening element 215b. Finally, the second flange 223b of the flap 223 is pressed against the folded drain portion to secure the rear fastening element 215a and the front fastening element 215b together.

[0133] In these embodiments, the drain portion 41 can be deployed by reversing the above procedure.

[0134] As with the first embodiment, in the second embodiment, the rear comfort layer 205 and the front comfort layer 206 are formed from a flexible sheet material comprised of a woven fabric layer with a continuous layer of film material laminated to one surface, i.e., its inner surface in use. In this embodiment, the woven fabric layer forms the outer surface of the rear comfort layer 205 and the front comfort layer 206, respectively, and a continuous layer of film material is disposed on the corresponding inner surface facing the rear wall 202 and the front wall 203. Other embodiments may include additional woven and / or film layers as desired. In this embodiment, the woven fabric layer comprises polyester, but in other embodiments, one or more of nylon, viscose, polyethylene, and polypropylene may be used in addition to or instead of the woven fabric layer.

[0135] In this embodiment, the fabric layer is 58 g / m 2 0.01 mm, a tensile strength of 280 N to 300 N, and a tear strength of 18 N. Other embodiments have different compositions, e.g., 50 g / m 2 from 70 g / m 2 The fabric may have an areal density of 100 to 400 N, a tensile strength of 200 to 400 N, and a tear strength of 10 to 30 N. Some embodiments may have a colorfastness rating of 4 to 5 against either rubbing, sweat, or washing (at 40°C), and may have a durability of 50,000 or more cycles in the abrasion test. Particular embodiments comprise a woven polyester with a water-repellent finish. The water-repellent finish may be fluorocarbon-based and may be dye-heatset or boil-off heatset. A suitable polyester woven layer is available from Newton Textiles, Northamptonshire, UK, under the designation 75DCWR, such as 75DCWRWHITE (white version).

[0136] In this embodiment, the continuous layer of film material is 23 g / m 2 A suitable EVA film is available from Protechnique, Cernay, France, under the designation 3X9S23.

[0137] In this embodiment, a continuous layer of film material is again laminated directly to the textile layer over the entire area of ​​the inner surface of the rear comfort layer 205 and front comfort layer 206, without the need for an intervening adhesive as the film layer itself is adhesive at high temperatures.

[0138] Advantageously, as with the first embodiment, the use of a continuous layer of film material allows both comfort layers 205, 206 and both walls 202, 203 to be simultaneously bonded to one another, if desired, in the same manner and with the same welding process as nonwoven materials, without the need for special intervening layers or adhesives during the construction process, and with adhesive properties even in areas where the textile layers are bonded to one another (i.e., overlapping areas). In this embodiment, peripheral welds defined by edge seals 208 join the rear comfort layer 205 to the rear wall 202 and the front comfort layer 206 to the front wall 203. In other embodiments, different welds may be used as needed or desired. For example, the welds may correspond to only a portion of the welds joining the rear wall 202 and the front wall 203. The welds attaching the rear comfort layer 205 to the rear wall 202 may be different from the welds attaching the front comfort layer 206 to the front wall 203.

[0139] Referring to Figure 7, a schematic diagram of an apparatus for use in the method of forming a pouch of the present invention is shown. In this embodiment, apparatus 300 includes four rollers 301, 302, 303, and 304, a stamp welder 305, and a cutter 306. Rollers 301, 302, 303, and 304 are used to advance first flexible sheet material 311, second flexible sheet material 312, third flexible sheet material 313, and fourth flexible sheet material 314, respectively, in the direction of arrow D. For simplicity, additional rollers used to advance the sheet materials are not shown.

[0140] In this embodiment, the device 300 is configured to construct an ostomy pouch 310 similar to the ostomy pouch 1,201 of Figures 1-6, which includes a rear comfort layer 5, 205, a rear wall 2, 202, a front wall 3, 203, and a front comfort layer 6, 206. However, this process is shown in a simplified manner without illustrating features such as the separation layer 4 or aspects of the drainage portion 41 described in the previous embodiments, or the assembly of wafers and filters, etc., which may be provided in a manner known to those skilled in the art.

[0141] The first sheet 311 and second sheet 312 of material are plastic films used for the rear and front walls, respectively, of the pouch 310. As such, the materials used for these sheets are the same and correspond to the materials described in connection with the ostomy pouch 1,201 described above.

[0142] In this embodiment, third and fourth sheets of material 313 and 314 are used for the rear and front comfort layers of pouch 310, respectively. As discussed above, the material used for the comfort layers comprises a woven fabric layer laminated to a continuous layer of film material. Thus, third and fourth sheets of material 313 and 314 comprise woven fabric layers 313a and 314a, which in turn have continuous layers 313b and 314b of film material laminated to woven fabric layers 313a and 314a, respectively. In FIG. 7, layers 313b and 314b of film material face each other, with first and second layers 311 and 312 of sheet material disposed therebetween, forming the rear and front walls of the cavity.

[0143] The third and fourth sheets of material 313 and 314 were preformed several days earlier in a separate facility using a lamination process, such as calendering, in which a thin, solid sheet of EVA film 313b, 314b (without voids therein) was unwound from a roll and laminated under high temperature and pressure directly onto a similarly unwound sheet of woven material 313a, 313b, then cooled and fed onto a new roll for rewinding. As noted above, no adhesive was present between the solid sheet of EVA film and the woven sheet. This process creates a continuous layer of EVA film of uniform thickness across the entire surface of the woven material and avoids the formation of voids in the continuous layers of EVA film 313b, 314b. For example, a laminate of EVA film available under the designation 3X9S23 from Protechnique, Cernay, France, can provide full surface coverage on a textile comfort material, and the thickness of the EVA film can remain substantially unchanged from a constant starting thickness of 23.2 μm ± 1 μm (23.2 μm = / - 1 μm) over its entire length and width.

[0144] In this embodiment, the stamp welder 305 is arranged to weld the layers of material together using a hot stamp, the shape of the weld corresponding to the peripheral seal 8 as depicted in the ostomy pouch 1,201 of Figures 1-3 and 4-6.

[0145] As can be seen in Figure 8 (a photograph of sheets 313 / 314 in the area of ​​peripheral seals 315, 8, 208), the welded area is virtually indistinguishable from the remainder of the sheets of textile material 313, 314. This can be visually compared with the image in Figure 9, where the weld perimeter (P) is clearly distinguishable by a mottled edge with unsightly dark spots (S) (not all of which are labeled).

[0146] Referring back to FIG. 7, in this embodiment, the cutter 306 is positioned to cut a portion of the advancing sheet of material in a shape defined by the periphery of the ostomy pouch.

[0147] In this embodiment, first, the first and second sheets 311 and 312 of material are first brought together by rollers (not shown) so that they are in contact and advance at the same speed. Next, the third and fourth sheets 313 and 314 of comfort material are brought together by rollers (not shown) on opposite sides of the first and second sheets 311 and 312 of film material. The third sheet 313 is positioned adjacent to the first sheet 311 so that the continuous layer 313b of film material faces the first sheet 311. Similarly, the fourth sheet 314 is positioned adjacent to the second sheet 313 so that the continuous layer 314b of film material faces the second sheet 312. Thus, all four sheets are in contact and advance at the same speed. Thus, the sheets are stacked in the following order: third sheet 313, first sheet 311, second sheet 312, fourth sheet 314.

[0148] In this embodiment, the advancing sheet of material then enters a stamp welder 305, which applies a heated stamp to the advancing sheet, forming a sealing weld 315 that corresponds to the periphery of the ostomy pouch 310. The heated stamp may be applied to either the comfort layer that will face back in use or the comfort layer that will face front in use, as direct application of heat prevents the continuous layer of film material from leaking through the fabric layer and causing unsightly spots / stains. This contrasts with the approach in PCT / GB2021 / 051340, which rigorously tested various EVA webs and found none that did not leak through the fabric on at least one side.

[0149] The successive layers of film material 313b, 314b facilitate welding of the fabric layers 313a, 314a to the first and second layers 311, 312. This is particularly noticeable when the successive layers of film material 313b, 314b are formed from the same material as the first and second layers 311, 312, for example, when they are all EVA. This process produces a series of sealed ostomy pouches 310 in the advancing sheet. In this embodiment, the stamping machine only welds the perimeter of the pouch, leaving a cavity within the pouch 310.

[0150] In this embodiment, the advancing sheet then enters a cutter 306, which cuts around the perimeter of the sealed weld line 315 formed by the stamper 305. This allows each ostomy pouch 310 to be released from the advancing sheet and retrieved or further prepared. Of course, welding and cutting may occur simultaneously.

[0151] In other embodiments, additional layers of material may be incorporated. In one embodiment, a fifth sheet of comfort layer material is used (not shown) and is applied to the same side of the pouch as the third sheet 313. This allows the front comfort layer to be comprised of an upper portion 6a and a lower portion 6b or 6bi, with the third layer forming the lower portion and the fifth layer forming the upper portion, as described above in connection with Figures 1-3. Advantageously, the third sheet 313 and the fifth sheet can be welded to the pouch simultaneously with the other layers to form a pouch having overlap region 115 in a single stamp welding process.

[0152] One or more embodiments have been described above by way of example only, and many variations are possible without departing from the scope of protection provided by the appended claims.

Claims

1. An ostomy pouch having a cavity for containing stoma output, the cavity being defined by a rear wall and a front wall joined at a periphery and formed of a flexible sheet material; the ostomy pouch further comprising a sheet of woven comfort material covering an exterior surface of the front wall; the sheet of comfort material having an outer surface and an opposite inner surface, the outer surface of the sheet of comfort material forming at least a portion of the outer surface of the pouch, the inner surface of the sheet of comfort material being laminated over its entire surface to a continuous layer of film material without an intervening adhesive; At least a portion of the continuous layer of film material is adjacent, facing, and unadhered to the exterior surface of the front wall.

2. 10. The ostomy pouch of claim 1, wherein the continuous layer of film material has a uniform thickness across the entire surface of the sheet of woven comfort material.

3. 3. The ostomy pouch of claim 1, wherein the continuous layer of film material has a thickness of less than 40 microns across the entire surface of the sheet of woven comfort material.

4. 4. The ostomy pouch of claim 3, wherein the continuous layer of film material has a thickness of less than 30 microns across the entire surface of the sheet of woven comfort material.

5. 5. The ostomy pouch of claim 4, wherein the continuous layer of film material has a thickness of between 20 microns and 25 microns across the entire surface of the sheet of woven comfort material.

6. The continuous layer of film material has a thickness of 18 g / m ２ to 30 g / m ２ 6. The ostomy pouch of claim 1, having an area density of

7. 7. The ostomy pouch of claim 1, wherein the continuous layer of film material is formed from the same material as the front and rear walls.

8. 8. The ostomy pouch of claim 1, wherein the continuous layer of film material, the front wall, and the rear wall are formed of polymers having the same chemical structure.

9. The continuous layer of film material, the front wall, and the back wall have the same molecular weight M ｎ 9. The ostomy pouch of claim 1, wherein the pouch is formed from a polymer having the formula:

10. The continuous layer of film material, the front wall, and the back wall have the same melting point M ｐ 10. The ostomy pouch of claim 1, wherein the pouch is formed from a polymer having the formula:

11. 11. The ostomy pouch of claim 1, wherein the continuous layer of film material, the front wall, and the rear wall are formed of polymers obtained from the same source and having the same name.

12. 13. The ostomy pouch of claim 1, wherein the continuous layer of film material is formed from EVA.

13. 13. The ostomy pouch of claim 12, wherein the front wall and the rear wall are formed of EVA.

14. Said continuous layer of film material has a thickness of at least 5 g / m ２ and 50 g / m ２ 14. The ostomy pouch of claim 1, having an areal density of:

15. 1. A method for forming a comfort layer laminate for adhering 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 without an intervening adhesive layer.

16. 16. The method of claim 15, wherein the continuous layer of film material is laminated to the sheet of comfort material by calendering under conditions of high temperature and pressure.

17. The continuous layer of film material has a uniform thickness across the entire surface of the sheet of woven comfort material, the thickness being between 20 microns and 30 microns across the entire surface of the sheet of woven comfort material, and the continuous layer of film material has a thickness of 18 to 30 g / m ２ and wherein the continuous layer of film material, the front wall, and the rear wall are formed of EVA.

18. 1. A method of forming an ostomy pouch, comprising: The method comprises: providing a sheet of comfort material having a continuous layer of film material laminated over a first surface thereof; Only a portion of the first surface of the sheet of comfort material is adhered to the exterior surface of the wall of the ostomy pouch cavity, such that at least a portion of the continuous layer of film material is adjacent, facing, and unadhered to the exterior surface of the front wall. A method comprising:

19. 1. A method of forming an ostomy pouch comprising first forming a comfort layer laminate for application to a cavity of the ostomy pouch, The method comprises: laminating a continuous layer of film material directly to the sheet of comfort material without an intervening adhesive layer to provide a sheet of comfort material having a continuous layer of film material laminated across its entire first surface; and adhering only a portion of the first surface of the sheet of comfort material to an exterior surface of a wall of the ostomy pouch cavity to form the ostomy pouch, whereby at least a portion of the continuous layer of film material is adjacent, facing, and unadhered to the exterior surface of the front wall. A method comprising:

20. 20. The method of claim 19, wherein the step of laminating a continuous layer of film material directly to a sheet of comfort material is performed separately in time from the step of adhering an inner surface of the sheet of woven comfort material to a wall of the pouch and at least 12 hours before adhering the inner surface of the sheet of comfort material to the wall.

21. 21. The method of any of claims 18 to 20, wherein the method includes adhering the first surface of the sheet of comfort material to the periphery of the wall of the cavity of the ostomy pouch, the method of adhering being welding.

22. the cavity being defined by a rear wall and a front wall joined at a periphery and formed of a flexible sheet material; The method includes providing a rear wall and a front wall formed from a flexible sheet material and joining the rear wall and the front wall around a periphery; The method further includes peripherally adhering an inner surface of the sheet of comfort material to one or more of the rear wall and / or the front wall of the ostomy pouch; 22. A method according to any one of claims 18 to 21, wherein the method comprises simultaneously joining the front and rear walls of the cavity and adhering a portion of the first surface of the sheet of comfort material to at least one of the walls of the cavity.

23. 23. The method of any one of claims 18 to 22, wherein the sheet of comfort material comprises two or more portions, the method comprising positioning the portions of the sheet of comfort material and adhering the portions of the sheet of comfort material to the pouch.

24. 18. An ostomy bag comprising a comfort layer laminate formed by the method of any one of claims 15 to 17.

25. 23. An ostomy pouch formed by the method of any one of claims 18 to 22.

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