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

[0002] Ostomy pouches come in various forms, including open / close, one-piece, and two-piece designs. Pouches can have a variety of shapes and components. Typically, a pouch has a cavity formed of film (usually plastic), often consisting of two layers, a front and a back, welded at the edges, with the back layer of film (closest to the ostomate's body during use) containing an opening for drainage into the pouch.

[0003] For the comfort of ostomates, a "comfort layer" is sometimes provided on the rear film layer, and usually on top of the front film layer as well. The comfort layer is made of a material that is more comfortable against the skin than the film. Typically, the comfort layer is made of nonwoven fabric, which is selected for its cost-effectiveness or ease of assembly, for example, because it can be easily attached to the film layer of the pouch in a welding process that bonds the film layers together at their edges.

[0004] However, recently, as part of efforts to make ostomate pouches less "medical" and more appealing to users, textile materials have been introduced as comfort materials for Soltz® Confidence B® products, which are described as "stylish" in advertising materials. Textile materials make it more likely that others who notice the pouch will mistake it for underwear rather than a medical device.

[0005] While desirable, the manufacture of ostomy pouches with woven comfort layers is considered complex. Soltz® Confidencebee® products appear to include a complete layer of specially selected film material adjacent to the woven layer. Thus, in one embodiment, moving outward from the ostomate, there is a rear woven comfort layer, an opaque rear wall defining one side of the cavity, a transparent front wall defining the other side of the cavity, an opaque intervening wall, and a front woven comfort layer. The front comfort layer is divided by a split section, comprising two parts, an upper and a lower, which overlap at the split section, allowing the comfort layer to be separated at the split section and the contents to be inspected through the transparent wall. The intervening layer similarly comprises two parts that are (only) bonded to the outer periphery of the two parts of the comfort layer. In this example, the intervening wall appears to prevent fraying of the edges of the comfort layer, prevent the contents from being visible, or aid in the workability of the bonded (slightly stretchable) fabric.

[0006] This additional wall presents numerous drawbacks for the pouch. These include increased structural complexity, higher costs, increased volume, and, due to the presence of yet another (separate) layer, increased noise during use and making the pouch more conspicuous.

[0007] Other prior art documents have also proposed the use of woven materials as one of the options for the comfort layer; for example, U.S. Patent Application Publication 2005 / 0273064 discloses a pouch in which the pouch walls forming the cavity are effectively integrated with the comfort layer. Thus, laminates including a woven layer, which may be a knitted fabric, woven fabric, or nonwoven fabric, have been proposed, and the woven layer is bonded to the film layer by a layer of adhesive that bonds the woven layer substantially continuously to the film layer. While this arrangement requires fewer layers than Soltz's Confidencebee product, it has the disadvantage that, for example, a typical comfort layer includes areas that are not bonded to the film layer forming the cavity, allowing the comfort layer to be pulled in and inspected internally, whereas in the pouch of U.S. Patent Application Publication 2005 / 0273064, this is not possible because the comfort layer is bonded substantially continuously to the pouch walls.

[0008] International Publication No. 2021 / 064409 refers to a comfort layer comprising at least one woven layer and at least one film layer, wherein the film layer is selectively laminated to the at least one woven layer over the entire area of ​​the at least one woven layer. There is no description of which side of the woven layer the film layer should be provided on, nor any detail of the laminate. When attempting to realize this aspect of the invention, a person skilled in the art would expect to use an intervening adhesive layer between the film and the woven fabric, similar to the laminate described in U.S. Patent Application Publication No. 2005 / 0273064.

[0009] Against this backdrop, PCT / GB2021 / 051340 proposes an ostomy pouch having a cavity for containing stoma waste, the cavity being defined by a posterior and anterior wall joined at the periphery and formed typically of a flexible sheet material. In this ostomy pouch, a sheet of woven comfort material covers the outer surface of the anterior wall, and the inner surface of the comfort material has a web of EVA hot melt adhesive. Except for the periphery to which the comfort material is bonded to the anterior wall, at least a portion of the web of EVA hot melt adhesive is adjacent to, facing, and not bonded to the outer surface of the anterior wall.

[0010] PCT / GB2021 / 051340 states that webs of hot melt adhesives, comprising lumps and multiple voids within those lumps, are considered advantageous over "full films" in that they avoid the rubbing noise associated with film and require less material compared to full films.

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

[0012] An object of an embodiment of the present invention is to at least partially overcome or alleviate 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 exit a stoma. Stomal output may include 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 of a torso. The term "stoma" may also refer to internal tissues, organs, and parts 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 with a surgical opening, but as used herein, "ostomate" may refer to a subject with a stoma, regardless of whether the stoma was formed surgically or by other means.

[0016] The term "user" may refer to an ostomate or a person who assists an ostomate, such as a person who empties stomal output from a cavity.

[0017] In this specification, the ostomy pouches disclosed herein may be used to manage a stoma created by, for example, esophagotomy, gastrectomy, cholecystostomy, common bile duct reconstruction, cecum reconstruction, colectomy, duodenum reconstruction, ileum reconstruction, jejunal reconstruction, appendectomy, tracheostomy, artificial bladder reconstruction, nephrostomy, ureter reconstruction, or cystostomy. The ostomy pouches disclosed herein may be used in conjunction with further devices including, but not limited to, shunts, catheters, plugs, or fecal management systems.

[0018] Beneficially, the ostomy pouches of this disclosure may enable ostomates to increase the lifespan 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 ostomate care and comfort. Additionally or alternatively, this may also be achieved by providing a means for reliably and hygienically removing stoma waste from the cavity, thereby increasing ostomates' confidence in reusing ostomy pouches compared to some prior art pouches. As ostomates tend to use each ostomy pouch of this disclosure for a longer period, the total number of ostomy pouches used by an ostomate over a given period may decrease. This may result in the environmental benefit of reducing the amount of environmental waste generated.

[0019] In this specification, the position and orientation of features may be described with reference to an ostomy pouch “in use” or an ostomy pouch “orientated as it would be in use.” Such terms refer to the intended orientation of the ostomy pouch when attached to the body of an upright ostomate, regardless of whether the ostomy pouch is currently performing such use or the actual position of the ostomate. The terms “upper” and “lower” and related terms refer to the relative position of a portion or part of the ostomy pouch when oriented as in use. For example, one section of an ostomy pouch may be called the “upper” section of the ostomy pouch. In such an example, the section is intended to be the uppermost section (in the vertical direction) of the ostomy pouch when attached to the body of an upright ostomate. However, as those skilled in the art will know, before attachment to the ostomate, the section is not always the uppermost section, and even after attachment to the ostomate, when the ostomate is not standing, for example, lying down, the section is not always the uppermost section.

[0020] The terms “left-hand” and “right-hand” and related terms refer to the ostomy pouch as viewed from the rear (for example, as shown in Figure 1). Therefore, in an exemplary example, when the ostomy pouch is attached to the front of the ostomate’s torso, the “left-hand” edge of the ostomy pouch faces the left side of the ostomate.

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

[0022] In this specification, the terms “front” and “rear” refer to the relative position of a portion or part of the ostomy pouch with respect 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 the relative position that is “front.” “Front” refers to a position that is relatively further away from the ostomate’s body than the relative position that is “outside.”

[0023] In this specification, the term "smoothly blends" and related terms refer to the smooth fusion of two edges, lines, or contours without abruptly altering their shape.

[0024] In this specification, the term “peripheral region” refers to the portion of an item that is located at or extending towards the edge of the item being referenced.

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

[0026] Ostomy pouches are generally attached to the body by an ostomy wafer containing one or more adhesive layers. The ostomy wafer generally has an opening for the stoma, sometimes called a starter hole, which may be cut to the required size by the user before attachment. The ostomy wafer generally has an adhesive layer on the body-facing side to adhere the ostomy wafer to the ostomate's body. Generally, the body-facing side of the ostomy wafer is covered with a release liner, which is removed by the user before conforming 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 “two-piece pouches” and “one-piece pouches.”

[0027] In this specification, “two-piece pouch” refers to an ostomy pouch in which an ostomy wafer forms part of a separate body-worn component that is attached to the rest of the pouch by a releasable coupling. The two-piece pouch allows the body-worn component to be separated from the pouch without damage, so that at least one of the components remains functionally usable. For example, the body-worn component can remain in place on the ostomate’s body.

[0028] In this specification, “one-piece pouch” refers to an ostomy pouch in which the ostomy wafer is permanently attached to the pouch to such an extent that it cannot be easily separated without risking damage to the pouch. One-piece pouches are intended to be used as a single unit.

[0029] Ostomy pouches can generally be configured as either closed or open pouches. In this specification, “closed pouch” refers to a pouch not intended for stoma waste to be discharged from a cavity. Therefore, closed pouches can generally be configured as single-use, non-reusable pouches. In this specification, “open pouch” refers to a pouch intended for stoma waste to be discharged from a cavity. Therefore, open pouches can be configured as reusable pouches and may be reused and emptied multiple times while attached to the body, although this is not mandatory. In an open pouch, stoma waste may be discharged intermittently as caused by the ostomate’s actions, or intermittently or continuously as a result of the cavity being fluidly connected to a drain, such as a nighttime 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 with layers of film material laminated over its inner surface. At least a portion of the inner surface may be adjacent to, facing, and not bonded to a cavity for containing stoma waste. The cavity may be defined by a posterior wall and an anterior wall, which may be joined at their periphery, 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 anterior wall. The sheet of comfort material may have an outer surface and an inner surface on the opposite side. 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 have its entire surface laminated 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 not bonded to the outer surface of the anterior wall.

[0031] According to a broad aspect of the present invention, an ostomy pouch is provided having a cavity for containing stoma waste, the cavity being defined by a posterior and anterior wall formed of a flexible sheet material joined at its periphery, the ostomy pouch further comprising a sheet of comfort material covering the outer surface of the anterior 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 in a continuous layer of film material, at least a portion of the continuous layer of film material being adjacent to, facing, and not bonded to the outer surface of the anterior 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, an ostomy pouch is provided having a cavity for containing stoma discharge, the cavity being defined by a posterior and anterior wall formed of a flexible sheet material joined at its periphery, the ostomy pouch further comprising a sheet of woven comfort material covering the outer surface of the anterior 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 into a continuous layer of film material without the interposition of adhesive, at least a portion of the continuous layer of film material being adjacent to, facing, and not bonded to the outer surface of the anterior wall.

[0033] A continuous layer of film material may be understood as meaning an uninterrupted layer, and may also be understood as a void-free "solid" layer, in contrast to PCT / GB2021 / 051340.

[0034] Forming webs, meshes, or nets typically requires spray coating techniques (spraying onto a comfort material, or spraying to form a layer, which is then formed into a roll and laminated onto the comfort material (disclosed in PCT / GB2021 / 051340)), so that such layers of film material do not have the property of leaking through the fabric material when the comfort material is welded to the cavity walls. Thus, for spray coating, the inventors understand that the EVA hot melt adhesive must necessarily be relatively low viscosity or have other properties that cause the problem of leaking through the comfort material. Without being bound by theory, the inventors believe that a high viscosity material makes it difficult for the comfort material to flow and can be easily manufactured as a continuous film. Therefore, in light of this disclosure, those skilled in the art can easily select a continuous film with the appropriate properties to avoid this problem.

[0035] Clearly, compared to Soltz®'s Confidence B® products, the ostomy pouch of the first embodiment of the present invention has advantages such as the absence of a separate intervening layer and therefore less rubbing noise. Furthermore, since the film layer is laminated to the woven comfort material without the intervening of an adhesive layer, the process of attaching the comfort layer to the cavity is simplified, and since the already laminated woven layer can be directly attached to the film forming the cavity, the number of rolls of material that need to be joined during the manufacturing process can be reduced.

[0036] Compared to U.S. Patent Application Publication No. 2005 / 0273064, the advantages are, naturally, almost identical to those in PCT / GB2021 / 051340.

[0037] The continuous layer of film material may have a uniform thickness (i.e., substantially uniform thickness) across the entire surface of the sheet of woven comfort material. The thickness deviation 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 the 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 woven comfort material sheet. The continuous layer of the film material may have a thickness of at least more than 10 microns (preferably more than 15 microns, more preferably more than 20 microns) across the entire surface of the woven comfort material sheet. For example, the continuous layer of the film material may have a thickness between 20 microns and 30 microns, for example, between 23 microns and 27 microns, for example, about 23 microns across the entire surface of the woven comfort material sheet.

[0039] The continuous layer of the film material is at least 0.5 g / m 2 、1 g / m 2 、5 g / m 2 、10 g / m 2 、15 g / m 2 、16 g / m 2 、or 20 g / m 2 and may have an areal density of, and / or, less than 500 g / m 2 、100 g / m 2 、50 g / m 2 、40 g / m 2 、35 g / m 2 、30 g / m 2 or 25 g / m 2 and may preferably have an areal density of from 10 g / m 2 to 50 g / m 2 、16 g / m 2 to 35 g / m 2 、18 g / m 2 to 30 g / m 2 or 20 g / m 2 to 25 g / m 2 、for example 23 g / m 2 and may have an areal density.

[0040] Therefore, in one preferred embodiment, an ostomy pouch is provided having a cavity for storing stoma waste, the cavity being defined by a posterior and anterior wall formed of a flexible sheet material joined at the periphery, the ostomy pouch further comprising a sheet of woven comfort material covering the outer surface of the anterior 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 interposing an adhesive, at least a portion of the continuous layer of film material being adjacent to, facing, and not bonded to the outer surface of the anterior wall, and the continuous layer of film material being 18 g / m 2 From 30g / m 2 It has a surface density of .

[0041] The continuous layer of film material is formed of a material that adheres to the comfort layer material without the need for an intermediary adhesive. Thus, the continuous layer of film material may also 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 back walls. This improves the fit of the comfort material into the cavity because the two materials typically melt at the same temperature during the plastic welding process and bond well to each other.

[0043] The continuous layer of the film material, the front wall, and the back wall may be formed of polymers having the same chemical structure. n It may be formed from a polymer having the same melting point M. The continuous layer of the film material and the front and back walls have the same melting point M. p It may be formed from a polymer having the following properties. The continuous layer of the film material, and the front and back walls may be formed from 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 properties that define similarity (e.g., structure, M) may be used. n M p ) should be guaranteed to be the same without the need for measurement.

[0044] The continuous layer of the film material is preferably formed of EVA. Alternatively, the continuous layer of the film material may be formed of other plastic materials, such as polyethylene, in which case the film is selected to have suitable properties in that it can adhere to the comfort material without the need for an adhesive layer and without leakage.

[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 surface of the pouch. Both the front and rear surfaces of the pouch may be formed from a sheet of woven comfort material. Thus, the ostomy pouch may further comprise a sheet of woven comfort material covering the outer surface of the rear wall, the sheet of comfort material having an outer surface and an inner surface on the opposite side, 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 in a continuous layer of film material, and at least a portion of the continuous layer of film material being adjacent to, facing, and not bonded to the outer surface of the rear wall.

[0046] Accordingly, such embodiments of the present invention provide a pouch having a continuous layer of film material laminated to a sheet of comfort material, where both sides (front and rear) are covered with a woven comfort material to improve user comfort, and the pouch can be easily manufactured without additional welding steps or the introduction of an intermediate layer, and adhesive does not leak through the comfort layer. In effect, the laminated sheet of comfort material can be bonded to the rest of the pouch, for example, a front wall defining one side of the cavity and a rear wall defining the other side of the cavity, in the same way that nonwoven fabrics are bonded (usually a single welding step in which the periphery of all layers is bonded to each other).

[0047] The woven comfort material may comprise one or more of the following: natural materials, such as cotton or wool, and / or synthetic materials, such as polyester, nylon, viscose, polyethylene, or polypropylene. The woven material may have a density of 20 g / m². 2From 200g / m 2 Preferably 40 g / m 2 From 80g / m 2 For example, 58 g / m 2 The woven material may have an area density of . The woven material may have a tensile strength of 200N to 400N, preferably 250N to 350N, for example, 300N in the warp and 280N in the weft. The woven material may have a tear strength of 5N to 50N, preferably 10N to 30N, for example, 18N. The woven material may have a colorfastness of 4 to 5 against one or more of the following: abrasion, sweat, and washing (40°C). The woven material may have a durability of 50,000 or more cycles in abrasion tests. The woven material may be waterproofed. For example, the woven material may comprise woven polyester that has been treated with a water-repellent finish. The water-repellent finish may be fluorocarbon-based. The water-repellent finish may be dye heat-set or boil-off heat-set.

[0048] The woven comfort layer may have a thickness of 50 to 1000 micrometers, preferably 60 to 500 micrometers, and more preferably 75 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, 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 comfort material sheet is adhered to the outer surface of the cavity wall at the periphery, but does not need to be adhered to the walls other than the periphery.

[0050] A 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 and a lower part. The upper and lower parts, when joined together, may have the same shape as the anterior wall. The upper part may extend from the top edge of the pouch to a position 20% to 50% below the top edge. The lower part may extend from the bottom edge of the pouch to a position 15% to 50% below the top edge. An overlapping region may be provided where the upper and lower parts overlap. The upper part may extend over the lower part (or vice versa), forming an overlap in the overlapping region. The upper and lower parts may be separable from each other in the overlapping region. The overlapping region may extend horizontally when the ostomy pouch is in use. Therefore, particularly when the anterior wall is formed of a transparent film, the present invention provides, if necessary, a device that allows for convenient observation of the stoma and / or pouch contents.

[0051] The pouch may be equipped with a drain. The drain may be located at the bottom of the pouch when in use. The drain may be formed from the front and back 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 closed in the folded configuration. The drain may be open in the unfolded configuration. When the drain is open, it may allow stoma waste to exit the pouch cavity. When the drain is closed, it may prevent stoma waste from exiting the pouch cavity.

[0052] The drain may comprise 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 local rigidity to the drain. Each purging strip may be formed from polystyrene. Each purging strip may define the position and orientation of one or more folds in the drain. Each purging strip may comprise a strip of flexible material attached to the drain. The strip may have greater rigidity than the material of the drain. Each purging strip may have some elasticity once attached to the drain. Thus, the purging strip can be compressed laterally, causing it to arch, which in turn can help open the drain.

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

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

[0055] A closure mechanism for the ostomy pouch drain may be attached to a sheet of comfort material covering the front of the pouch. The closure mechanism may be attached to the 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. Welding may be performed along the upper 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 be fastened in cooperation with a rear fastening element. When the fastening members are tightened, the drain may be closed.

[0056] The closure flap may comprise a woven comfort material (optionally comprising a continuous layer of film material). This is preferable because forming the closure flap with the same material as the comfort material makes it more discreet / inconspicuous.

[0057] The front fastening element may be positioned above the rear fastening element. The front fastening element may be positioned adjacent to the lower end of the comfort material. A longitudinal gap may be provided between the upper edge of the rear fastening element and the lower edge of the front fastening element. The longitudinal gap may define the position of the drain fold. The rear fastening element may be positioned adjacent to the upper end of the drain.

[0058] The drain may be closed by repeatedly folding it upward around a crease defined by the front and rear pursing strips and the front and rear fastening elements. The folded drain may be held between the woven comfort material and the closing flap. Both sides of the closing flap do not have to extend beyond the edges of the comfort material. The closing flap may have tabs. The tabs may extend beyond the lower edge of the comfort material. The front and rear fastening elements may be the same size. The front and rear fastening elements do not have to straddle the width of the drain.

[0059] Therefore, the drain can be conveniently closed against the comfort material and secured in place by the closing flap. Thus, there is no need to fold the drain or secure it under the comfort material, making the pouch easier to use. The tab allows access to release the fastening elements by lifting the closing flap, as well as including fastening elements that do not span the entire width of the drain, making it easier to deploy the drain.

[0060] A second aspect of the present invention provides a method for forming a comfort layer laminate for bonding to the cavity of an ostomy pouch, the method comprising directly laminating a continuous layer of film material to a sheet of comfort material without interposing an adhesive layer.

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

[0062] Naturally, the comfort layer and the film material should be suitable and easily adaptable to the described material and / or the film material layer as a backing for the comfort layer, but may have any of the characteristics outlined above, such as a maximum thickness that makes them unsuitable for forming cavity walls.

[0063] Therefore, in one embodiment, for example, the comfort material layer is a woven fabric. A method is provided for forming a comfort layer laminate for bonding to the cavity of an ostomy pouch, the method comprising directly laminating a continuous layer of film material to a sheet of woven comfort material without an intervening adhesive layer.

[0064] Naturally, the method should form the material such that the layers of comfort material are maintained continuously, meaning that no step of the method should introduce any gaps or openings. Thus, in one embodiment, a method is provided for forming a comfort layer laminate for bonding to the cavity of an ostomy pouch, the method comprising laminating a continuous layer of film material directly onto a sheet of comfort material without an intervening adhesive layer to form a woven sheet of comfort material having an outer surface and an inner surface on the opposite side, the inner surface of the sheet of comfort material being laminated over its entire surface onto the continuous layer of film material without an intervening adhesive, and the continuous layer of film material being a gapless, uninterrupted "solid" layer.

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

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

[0067] Thus, a preferred method for forming an ostomy pouch comprises first forming a comfort layer laminate for application to the cavity of the ostomy pouch, the method comprising directly laminating a continuous layer of film material 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 over the entire first surface, and then forming an ostomy pouch by bonding only a portion of the first surface of the sheet of comfort material to the outer surface of the cavity wall of the ostomy pouch, so that at least a portion of the continuous layer of film material is adjacent to, facing, and not bonded to the outer surface of the front wall.

[0068] The step of directly laminating a continuous layer of film material onto a 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 separately in terms of time, for example, for 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 directly laminating a continuous layer of film material onto a sheet of comfort material may be performed physically 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 in a different room, a different building, or in a different city, county, or state.

[0069] Accordingly, a method for forming an ostomy pouch is provided, comprising first forming a comfort layer laminate for application to the cavity of the ostomy pouch in one embodiment, the method providing a sheet of comfort material having a continuous layer of film material laminated over the entire first surface by directly laminating a continuous layer of film material to a sheet of comfort material without an intervening adhesive layer, and then forming an ostomy pouch by adhering only a portion of the first surface of the sheet of comfort material to the outer surface of the cavity wall of the ostomy pouch, thereby so that 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 the step of directly laminating the continuous layer of film material to the sheet of comfort material is performed at least 12 hours before adhering the inner surface of the sheet of comfort material to the wall, and separately in time from the step of adhering the inner surface of the woven sheet of comfort material to the wall of the pouch.

[0070] Preferably, the method comprises adhering the first surface of a comfort material sheet to the periphery of the cavity wall of the ostomy pouch. Preferably, the bonding method is welding.

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

[0072] The comfort material sheet may comprise two or more parts, and the method may include arranging multiple parts of the comfort material sheet and bonding multiple parts of the comfort material sheet to a pouch. The bonding of multiple parts may be performed simultaneously. Bonding may be performed by welding. Thus, the present invention enables the application of materials with complex arrangements to pouches in a single manufacturing step, reducing manufacturing complexity and cost.

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

[0074] A fifth aspect of the present invention provides a method for collecting stoma waste using an ostomy pouch according to any aspect described herein. The method may comprise attaching the ostomy pouch to the ostomy of an ostomate. If the pouch comprises a one-piece ostomy pouch, the ostomy pouch may be attached to the stoma using the ostomy wafer of the pouch. Alternatively, the method may comprise attaching the ostomy wafer of the 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 a dischargeable pouch, the method may comprise discharging stoma waste from the ostomy pouch.

[0075] Here again, the fifth aspect of the present invention may include any feature related to any of the first to fourth aspects of the present invention.

[0076] To better understand the present invention, one or more embodiments of the present invention will be described only illustratively with reference to the accompanying drawings. [Brief explanation of the drawing]

[0077] [Figure 1] Figure 1 is a posterior view of the ostomy pouch. [Figure 2] Figure 2 is a front view of the ostomy pouch shown in Figure 1. [Figure 3] Figure 3 is a cross-sectional side view of the ostomy pouch shown in Figure 1. [Figure 4] Figure 4 is a front view of an alternative ostomy pouch. [Figure 5] Figure 5 is a cross-sectional side view of the ostomy pouch shown in Figure 4. [Figure 6] Figure 6 is an exploded perspective view of the ostomy pouch shown in Figure 4. [Figure 7] Figure 7 is a side view of the apparatus used to manufacture ostomy pouches. [Figure 8] Figure 8 is a partial view of an ostomy pouch according to any embodiment of Figures 1 to 8, showing no leakage of the laminated film layer through the woven comfort material in the region where the comfort material is bonded to the cavity. [Figure 9] Figure 9 is a partial view of an ostomy pouch having a layer of comfort material manufactured according to a prior art method, showing that hot melt adhesive is leaking through the woven comfort material in the area where the comfort material is bonded to the cavity. [Modes for carrying out the invention]

[0078] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art in the field to which the subject matter described in the claims pertains. It should be understood that the above summary of this disclosure and the following examples are illustrative and descriptive, and do not limit any subject matter described in the claims.

[0079] The following description is directed toward embodiments of the present disclosure. The description of embodiments is not intended to include all possible embodiments of the present disclosure as described in the appended claims. Many modifications, improvements, and equivalents not expressly described in the following embodiments may be included in 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] In this specification, unless otherwise clearly indicated by the context, the use of the singular form includes the plural form. In this application, the use of "or" means "and / or" unless otherwise specified. Furthermore, the use of the term "including" is not limited to other forms such as "include," "includes," and "included."

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

[0082] Referring to Figures 1 to 3, an embodiment of the present invention is shown in which the 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 present invention as described in the claims, one or more of the separation wall 4, the rear comfort layer 5, and the front comfort layer 6 may be omitted as desired.

[0083] In this embodiment, the ostomy pouch 1 is a single-piece pouch, and the ostomy wafer 7 is permanently attached to the ostomy pouch 1 (in the sense that it cannot be easily removed without damaging the pouch and cannot be reattached). However, other embodiments may be a two-piece pouch comprising a pouch component and a body-mounted component, the pouch component and the body-mounted component together forming 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-mounted component comprises the ostomy wafer 7.

[0084] The posterior wall 2 and the anterior wall 3 define a cavity for containing stoma waste. In this embodiment, both the posterior wall 2 and the anterior wall 3 are formed from a 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 it 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 has a left edge 13 and a right edge 14 when viewed from the rear. 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, as long as they are inconspicuous and comfortable to wear during use. Exemplary dimensions and other suitable shapes are described in the prior art documents cited in the introduction, for example, PCT / GB2021 / 051340 incorporated by reference.

[0088] In this embodiment, the left edge 13c and the right edge 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 have continuously curved edges 15 and 16, respectively. The curved edges 15 and 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 and 16 are convexly curved with radii of curvature r2 and r3, respectively. In this embodiment, r2 and r3 are constant along the corresponding edges 15 and 16, respectively, but in alternative embodiments, they may be variable.

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

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

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

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

[0094] The posterior wall 2 is provided with a stoma opening 20 for receiving stoma waste into the cavity. The stoma opening 20 is an opening in the upper section 10 of the ostomy pouch 1 where the posterior wall 2 is cut out, and a wafer 7 is provided inside it, the wafer having a hole through which the stoma normally extends.

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

[0096] The rear comfort layer 5 and the front comfort layer 6 are formed from a flexible sheet material consisting of a woven fabric layer, which is laminated over the entire surface of a continuous layer of film material. The continuous layer of film material forms a seamless solid layer without voids, and therefore completely covers one surface of the comfort layer 6, i.e., the inner surface during use.

[0097] In this embodiment, the woven layers form the outer surfaces of the rear comfort layer 5 and the front comfort layer 6, respectively, and the continuous layers of film material are arranged on the corresponding inner surfaces and face the rear wall 2 and the front wall 3. In other embodiments, additional woven layers and / or film layers may be provided as needed. In this embodiment, the woven layers may be made of polyester, but in other embodiments, one or more of nylon, viscose, polyethylene, and polypropylene may be used in addition or as substitutes.

[0098] In this embodiment, the woven layer is 58 g / m². 2It has an area density, a tensile strength of 280N to 300N, and a tear strength of 18N. Other embodiments have different compositions, for example, 50g / m 2 From 70g / m 2 It may have an area density, a tensile strength of 200N to 400N, and a tear strength of 10N to 30N. Some embodiments may have a colorfastness of 4 to 5 to abrasion, sweat, or washing (40°C), and may have durability of 50,000 or more cycles in abrasion tests. Certain embodiments include a water-repellent woven polyester. The water-repellent treatment may be fluorocarbon-based and may be dye-heat-set or boil-off heat-set. Suitable polyester fabric layers are available from Newton Textiles Ltd. in Northamptonshire, UK, under the name 75DCWR, such as 75DCWRWHITE (white version).

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

[0100] In this embodiment, the continuous layer of the film material is 23 g / m². 2 It has the following area density. A suitable EVA film can be obtained from Protechnik in Cernay, France, under the name 3X9S23.

[0101] The continuous layer of film material is laminated onto the fabric layer over the entire inner surface area of ​​the rear comfort layer 5 and the front comfort layer 6. Through lamination processing, such as calendering at high temperature and pressure, a laminate is formed in which the continuous layer of film material extends uniformly and without gaps over the entire surface 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 layer; rather, the continuous layer of film material is directly laminated onto the comfort layer.

[0102] Advantageously, by providing a continuous layer of film material, both comfort layers 5, 6 and both walls 2, 3 can be joined to each other simultaneously using the same welding process as in which nonwoven material is attached, if desired, improving joinability and eliminating the need for special intervening layers or adhesives during the construction process. In this embodiment, the peripheral weld defined by the edge seal 8 joins the rear comfort layer 5 to the rear wall 2 and the front comfort layer 6 to the front wall 3. In other embodiments, various 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. Furthermore, the continuous layer of film material protects the woven layers from undesirable fraying.

[0103] In this embodiment, the front comfort layer 6 comprises an upper portion 6a and a lower portion 6b, which, when joined together, have the same shape as 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, passing below the upper portion 6a, to slightly above the inflection point 17. Thus, the upper portion 6a partially overlaps with the lower portion 6b in the overlapping region 115. The upper portion 6a and the lower portion 6b are separable from each other in the overlapping region 115, forming a window opening for viewing the cavity. The overlapping region 115 extends horizontally when the ostomy pouch 1 is in use. In some embodiments, the overlapping region 115 does not have to coincide with the inflection point 17 and may straddle the pouch 1 at any suitable position along the length of the pouch 1. Importantly, if there is no continuous layer of film material, regardless of the choice of materials for walls 2 and 3, the two portions 6a and 6b of the front comfort layer 6 will not be joined to each other at all, because the wall material is not involved in the joining of those areas.

[0104] In other embodiments, the front layer may consist of multiple parts. The external shape and dimensions of the multiple parts may be the same as those of the front wall 3 when the multiple parts are joined together.

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

[0106] The ostomy pouch 1 may have a gas outlet for releasing stoma gas from the cavity. In this embodiment, the ostomy pouch 1 includes a gas outlet filter 24, which also serves as an odor filter. A suitable filter may be a charcoal filter or an activated carbon filter to suppress the release of unwanted odors from the cavity. The gas outlet filter 24 forms part of the gas outlet, which includes a gas outlet opening 27 located in the front wall 3. In some embodiments, the gas outlet filter 24 is covered by a filter cap, and the gas outlet filter 24 and filter cap are located on the front wall 3, covering the gas outlet opening 27. The gas outlet opening 27 allows gas to pass from the cavity to the outside of the ostomy pouch through the gas outlet filter 24 and filter cap.

[0107] In this embodiment, the gas outlet is located in the upper quarter of the ostomy pouch 1 when in use. In particular, the center of the gas outlet opening 27 is positioned above the center of the stoma inlet 20 when in use. In other embodiments, the gas outlet 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 includes a separation filter 100 for filtering stoma gas and / or stoma fluid from stoma solids contained in the stoma discharge. Thus, the separation filter 100 prevents stoma solids from coming into contact with the gas outlet and clogging or otherwise impairing the function of the gas outlet filter 24.

[0109] In this embodiment, the separation wall 4 has the same external 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 joined to the rear wall 2 and the front wall 3 by welding at their periphery, forming a liquid-tight seal between them. In another embodiment, the separation wall 4 is joined to the rear wall 2 and the front wall 3 along the entire edge of the upper 10, and additionally, to the front wall 3 by horizontal welding 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 in 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 except through the separation filter 100.

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

[0112] Referring to Figures 4 to 6, further embodiments of the ostomy pouch 201 according to the present invention are similar to the embodiments shown in Figures 1 to 3, and similar features are given similar reference numerals with 200 added. The main difference is that the lower section 211 of the further embodiment is shaped to accommodate / form a foldable drain. Thus, in contrast to the embodiments described above, 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, and therefore the cavity is not divided into two sections. The rear wall 202 has a large opening 202i that is aligned with the stoma inlet 207i of the wafer 207 (the wafer 207 is connected to the rear wall 202 in the region between the periphery of the opening 202i and the periphery of the wafer, so that stoma waste enters the cavity through the stoma inlet of the wafer and the opening 202i of the rear wall). The rear comfort layer 205 also has an opening 205i that is slightly larger than the opening 202i of the rear wall 202 and aligned with the opening 202i, so as to be sandwiched between the outermost edge of the wafer and the rear wall 202. The stoma inlet 207i is adjustable to fit the ostomate's stoma.

[0114] Similar to the first embodiment, the front comfort layer 206 in this embodiment is formed from two parts: an upper portion 206a and a lower portion 206b. The upper portion 206a overlaps the lower portion 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 portion 206a, which overlaps the upper edge 232 of the lower portion 206b.

[0115] In this embodiment, a selective gas filter 224 is provided, positioned on the front wall 203 at a height above the stoma inlet 207i, to allow gas to exit the pouch 201. In this embodiment, the filter 224 is covered by a selective filter cover patch 225 (not shown in Figure 5) on the outer surface of the front wall 203. Thus, the filter 224 and the filter cover patch 225 are covered by the upper part 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 an unsealed portion of the periphery of the ostomy pouch 201, where the rear wall 202 and the front wall 203 are not sealed.

[0117] In this embodiment, the lower section 211 comprises a rounded portion 211a and a substantially rectangular drain portion 41 that accommodates the drain opening 40, the rounded portion 211a being adjacent to the waist section 212 and the drain portion 41 being distal to the waist section 212. The drain portion 41 is foldable along its longitudinal direction between an unfolded configuration and a folded configuration, as will be described later.

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

[0119] The left edge 42d and the right edge 43d of the drain section 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 vertex 44 of the drain opening 40 to the right vertex 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 passage extending from the cavity of the ostomy pouch 201 to a drain opening 40 located at the lower end of the drain portion 41. Since the drain portion 41 is integral with the lower section 211, the rear wall 202 and the front wall 203 may be made of a single material including the upper section 210, the waist section 212, and the lower section 211 (including the drain portion 41), respectively. 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, the cavity and the elongated drain passage are connected via a drain inlet 200 defined as a transition point between the cavity and the drain section 41. The drain inlet 200 allows stoma waste to pass from the cavity to the drain section 41 when the drain section 41 is deployed.

[0123] In this embodiment, moving the drain section 41 between an unfolded and folded configuration causes the drain opening 40 to open and close. This allows or prevents the outflow of stoma waste contained in the cavity of the ostomy pouch 1.

[0124] In this embodiment, the drain portion 41 can be repeatedly folded along its length in the same orientation, and is folded into multiple segments having substantially 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 each other. Each fold is formed across the width of the drain portion 41 and acts to suppress, preferably prevent, stoma waste from coming out of the drain opening 40.

[0125] In this embodiment, a first purging strip 221 and a second purging strip 222 are provided in the drain section 41. Both purging strips 221 and 222 provide local rigidity to the drain section 41 and define the position and direction of the segments and folds of the drain section 41. The purging strips 221 and 222 consist of strips of flexible material attached to the drain section 41, and the strips 221 and 222 have higher rigidity than the material of the drain section 41. Furthermore, the purging strips 221 and 222 have elasticity such that once they are attached to the drain section 41, they are compressed laterally, causing them to become bow-shaped, 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 and 222 are formed from polystyrene, but in other embodiments, they may be made of 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 to the drain opening 40. The second purging strip 222 is attached to the front wall 203 of the drain section 41 above the second strip 222. 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 position 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 positioned on the rear wall 202, and the front fastening element 215b is positioned on the flap 223 attached to the front comfort layer 206. In this two-part structure of the front comfort layer 206, the flap 223 is attached to the lower portion 206b of the comfort layer 206. The rear fastening element 215a and the front fastening element 215b each have corresponding hook-and-loop fastener elements. The rear fastening element 215a is positioned on the drain portion 41 above the second purging strip 222. A longitudinal gap is provided between the upper edge of the second purging 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 drain portion 41.

[0129] In this embodiment, the flap 223 comprises a first flange 223a and a second flange 223b formed as a single piece. The first flange 223a spans substantially the entire width of the rounded lower section 211a, but does not extend beyond the edge seal 208 at a point one-third of the way from the drain inlet 200 over the length of the rounded section 211a. 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 on its inner surface. Thus, welding between the outer surface of the comfort layer 206b and the flap 223 is made possible 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 by the first flange 223a alone. The second flange 223b is formed to conform to the shape of the rounded portion 211a, but thins to follow the inner edge of the peripheral weld portion 208. Thus, 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 inner surface on the opposite side. The front fastening element 215b is positioned above the rear fastening element 215a and is located on the inner surface of the second flange 223b. 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 portion 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, front wall 203, and comfort layers 205, 206. In this embodiment, the flap 223 is formed from a plastic foam that provides the desired rigidity.

[0132] The drain section 41 may be folded as follows: First, the distal end of the drain section 41 is folded upward away from the back 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 section 41 and the purging strips 221, 222 are folded again in the same orientation along a second fold line, 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 section, securing both the rear fastening element 215a and the front fastening element 215b.

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

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

[0135] In this embodiment, the woven layer is 58 g / m². 2 It has an area density, a tensile strength of 280N to 300N, and a tear strength of 18N. Other embodiments have different compositions, for example, 50g / m 2 From 70g / m 2 It may have an area density, a tensile strength of 200N to 400N, and a tear strength of 10N to 30N. Some embodiments may have a colorfastness of 4 to 5 to abrasion, sweat, or washing (40°C), and may have durability of 50,000 or more cycles in abrasion tests. Certain embodiments include a water-repellent woven polyester. The water-repellent treatment may be fluorocarbon-based and may be dye-heat-set or boil-off heat-set. Suitable polyester fabric layers are available from Newton Textiles Ltd. in Northamptonshire, UK, under the name 75DCWR, such as 75DCWRWHITE (white version).

[0136] In this embodiment, the continuous layer of the film material is 23 g / m². 2 It has the following area density. A suitable EVA film can be obtained from Protechnik in Cernay, France, under the name 3X9S23.

[0137] In this embodiment, the continuous layer of film material is again directly laminated to the fabric layer over the entire inner surface area of ​​the rear comfort layer 205 and the front comfort layer 206, and since the film layer itself is adhesive at high temperatures, there is no need to interpose an adhesive.

[0138] Advantageously, as in the first embodiment, by using a continuous layer of film material, both comfort layers 205, 206 and both walls 202, 203 can be joined to each other simultaneously in the same welding process as in which nonwoven material is attached, as desired, without the need for any special intervening layer or adhesive application during the construction process, and adhesive properties are maintained even in the areas where the woven layers are joined to each other (i.e., overlapping areas). In this embodiment, the peripheral weld defined by the edge seal 208 joins the rear comfort layer 205 to the rear wall 202 and the front comfort layer 206 to the front wall 203. In other embodiments, various welds may be used as needed or desired. For example, the weld may correspond to only a portion of the weld that joins the rear wall 202 and the front wall 203. The weld that attaches the rear comfort layer 205 to the rear wall 202 may be different from the weld that attaches the front comfort layer 206 to the front wall 203.

[0139] Referring to Figure 7, an apparatus used for forming a pouch according to the present invention is schematically shown. In this embodiment, the apparatus 300 comprises four rollers 301, 302, 303, and 304, a stamp welding machine 305, and a cutting machine 306. The rollers 301, 302, 303, and 304 are used to advance the first flexible sheet material 311, the second flexible sheet material 312, the third flexible sheet material 313, and the fourth flexible sheet material 314 in the direction of arrow D, respectively. For simplification, additional rollers used to advance the sheet material are not shown.

[0140] In this embodiment, the apparatus 300 is configured to construct an ostomy pouch 310 similar to the ostomy pouch 1,201 shown in Figures 1 to 6, comprising 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 describing features such as the configuration of the separation layer 4 or drain section 41 as described in the above embodiment, or the assembly of wafers and filters, etc., which can be provided in ways well known to those skilled in the art.

[0141] The first sheet 311 and the second sheet 312 of the material are plastic films used for the posterior and anterior walls of the pouch 310, respectively. Thus, the materials used for these sheets are the same and correspond to the materials described above in relation to the ostomy pouch 1,201.

[0142] In this embodiment, the third sheet 313 and the fourth sheet 314 of the material are used for the rear comfort layer and the front comfort layer of the pouch 310, respectively. As described above, the material used for the comfort layer comprises a woven fabric layer, on which a continuous layer of film material is laminated. Thus, the third sheet 313 and the fourth sheet 314 of the material comprise woven fabric layers 313a and 314a, and the woven fabric layers 313a and 314a each have continuous layers 313b and 314b of film material laminated on the woven fabric layers 313a and 314a, respectively. In Figure 7, the layers 313b and 314b of the film material face each other, and the first layer 311 and the second layer 312 of the sheet material, which form the rear and front walls of the cavity, are arranged between them.

[0143] The third sheet 313 and the fourth sheet 314 of the material were pre-formed a few days earlier in a separate facility by a lamination process such as calendering. In this process, thin but solid sheets (without voids) of EVA film 313b and 314b are fed from a roll and directly laminated onto sheets of woven material 313a and 313b, which are similarly fed from the roll, under high temperature and pressure. After cooling, they are fed onto a new roll and wound up. As described above, no adhesive is interposed between the solid sheets of EVA film and the woven sheets. This process forms a continuous layer of EVA film of uniform thickness across the entire surface of the woven material, preventing the formation of voids in the continuous layers of EVA film 313b and 314b. For example, a laminate of EVA film available from Protechnik in Cernay, France, under the name 3X9S23, allows the laminate to cover the entire surface of a woven comfort material, and the thickness of the EVA film can remain substantially constant from a constant initial thickness of 23.2 μm ± 1 μm (23.2 μm = -1 μm) over its entire length and width.

[0144] In this embodiment, the stamp welding machine 305 is positioned to weld layers of material together using hot stamping. The shape of the weld corresponds to the peripheral seal 8, as shown in the ostomy pouch 1,201 in Figures 1 to 3 and Figures 4 to 6.

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

[0146] Referring back to Figure 7, in this embodiment, the cutting machine 306 is positioned to cut a portion of the sheet of material as it advances in a shape defined by the outer circumference of the ostomy pouch.

[0147] In this embodiment, first, the first sheet 311 and the second sheet 312 of the material are joined together by rollers (not shown) so that they are in contact and moving forward at the same speed. Next, the third sheet 313 and the fourth sheet 314 of the comfort material are joined together by rollers (not shown) on opposite sides of the first sheet 311 and the second sheet 312 of the film material. The third sheet 313 is placed adjacent to the first sheet 311 so that the continuous layer 313b of the film material faces the first sheet 311. Similarly, the fourth sheet 314 is placed adjacent to the second sheet 213 so that the continuous layer 314b of the film material faces the second sheet 212. Thus, all four sheets are in contact and move forward at the same speed. Therefore, the sheets are stacked in the order of third sheet 313, first sheet 311, second sheet 312, and fourth sheet 314.

[0148] In this embodiment, the advancing sheet of material then enters the stamp welding machine 305. The stamp welding machine 305 presses a heated stamp against the advancing sheet to form a seal weld line 315 corresponding to the outer circumference of the ostomy pouch 310. The heated stamp may be applied to either the comfort layer that will be on the rear side or the comfort layer that will be on the front side during use, because applying heat directly prevents the continuous layer of film material from leaking through the fabric layer and causing unsightly spots / stains. This point is in contrast to the approach in PCT / GB2021 / 051340, in which, despite rigorous testing of various EVA webs, none were found that did not leak through the fabric on at least one side.

[0149] The continuous layers 313b and 314b of the film material facilitate the welding of the woven layers 313a and 314a to the first layer 311 and the second layer 312. This is particularly evident when the continuous layers 313b and 314b of the film material are formed from the same material as the first layer 311 and the second layer 312, for example, when they are all EVA. This process generates a series of sealed ostomy pouches 310 on the advancing sheet. In this embodiment, the stamping machine welds only the outer periphery of the pouch, leaving a cavity inside the pouch 310.

[0150] In this embodiment, the advancing sheet then enters the cutting machine 306. The cutting machine cuts around the outer circumference of the sealed weld line 315 formed by the stamping machine 305. This releases each ostomy pouch 310 from the advancing sheet, allowing it to be collected or further prepared. Of course, welding and cutting may be performed simultaneously.

[0151] In other embodiments, additional materials may be introduced. In one embodiment, a fifth sheet of comfort layer material is used (not shown) and applied to the same side of the pouch as the third sheet 313. This allows the front comfort layer to be composed of an upper portion 6a and a lower portion 6b or 6bi, for example, with the third layer forming the bottom and the fifth layer forming the top, as described above in relation to Figures 1 to 3. Advantageously, the third sheet 313 and the fifth sheet are welded to the pouch simultaneously with the other layers, allowing the pouch with the overlapping region 115 to be formed in a single stamp welding process.

[0152] One or more embodiments are described above for illustrative purposes only. Many modifications are possible without departing from the scope of protection provided by the appended claims.

Claims

1. An ostomy pouch having a cavity for collecting stoma waste, The cavity is defined by a rear wall and a front wall, which are joined at the periphery and formed of a flexible sheet material. The ostomy pouch further comprises a sheet of woven comfort material covering the outer surface of the anterior wall, The comfort material sheet has an outer surface and an inner surface on the opposite side, the outer surface of the comfort material sheet forms at least a portion of the outer surface of the pouch, and the inner surface of the comfort material sheet is laminated over its entire surface onto a continuous layer of film material without the interposition of an adhesive. The continuous layer of the film material is a continuous layer without gaps, An ostomy pouch in which at least a portion of the continuous layer of the film material is adjacent to, facing, and not bonded to the outer surface of the front wall.

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

3. The ostomy pouch according to claim 1 or 2, wherein the continuous layer of the film material has a thickness of less than 40 microns across the entire surface of the sheet of woven comfort material.

4. The continuous layer of the film material has a density of 18 g / m². ２ From 30 g / m ２ An ostomy pouch according to claim 1 or 2, having the area density of the following.

5. The ostomy pouch according to claim 1 or 2, wherein the continuous layer of the film material is formed of the same material as the front wall and the rear wall.

6. The ostomy pouch according to claim 1 or 2, wherein the continuous layer, the front wall, and the rear wall of the film material are formed of a polymer having the same chemical structure.

7. The continuous layer, the front wall, and the back wall of the film material have the same molecular weight M ｎ and the same melting point M ｐ An ostomy pouch according to claim 1 or 2, formed of a polymer having the following properties.

8. The ostomy pouch according to claim 1 or 2, wherein the continuous layer, the front wall, and the rear wall of the film material are formed of polymers obtained from the same source and having the same name.

9. The ostomy pouch according to claim 1 or 2, wherein the continuous layer of the film material is formed of EVA.

10. The ostomy pouch according to claim 9, wherein the anterior wall and the posterior wall are formed of EVA.

11. The continuous layer of the film material has a density of at least 5 g / m². ２ Therefore, 50 g / m ２ The ostomy pouch according to claim 1 or 2, having the following area density.

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