Ostomy bag

Abstract

The invention relates to an ostomy bag comprising a cavity for storing an ostomy output. The cavity is defined by a rear wall and a front wall, which are joined at their peripheries and are formed from a flexible sheet. The ostomy bag also includes 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 opposing inner surface, and the outer surface of the sheet of comfort material forms at least a portion of the outer surface of the pocket. The inner surface of the sheet of comfort material is laminated across its entire surface onto the continuous layer of film material. At least a portion of the continuous layer of film material is adjacent and facing the outer surface of the front wall and is not bonded to the outer surface of the front wall.

Description

Technical Field

[0001] The present invention relates to an ostomy bag for managing stomal effluent. Background Art

[0002] There are many forms of ostomy bags, such as open and closed, one-piece or two-piece. Bags can have various shapes and various components. Typically, they include a cavity formed by a film (usually a plastic film), usually formed by welding / melting / pressing together the front and back layers at their peripheries, the back layer of the film (the layer closest to the body of the ostomate in use) including an orifice through which the effluent can enter the bag.

[0003] For the comfort of the ostomate, a "comfort layer" may be provided which overlies the rear film layer and usually also the front film layer. The comfort layer is made of a material which is more comfortable against the skin than the film. Typically, the comfort layer is a nonwoven / non-woven material - non-woven materials are chosen for their cost and ease of assembly, for example, because they can be easily attached to the film layer of the bag by the same welding process which bonds / bonds the film layers to each other at their peripheries.

[0004] However, recently, as part of an effort to make ostomy bags look less "medical" and more attractive to users, woven materials have been introduced as a comfort material for the Salts (RTM) Confidence BE (RTM) product, which is described in advertising materials as a "fashionable fit". Woven materials are more likely to be mistaken by others for underwear rather than a medical device.

[0005] While this is considered desirable, the production of ostomy bags with a woven comfort layer is considered to be complex. The Salts (RTM) Confidence BE (RTM) product appears to include an integral layer of a specially selected film material adjacent to a woven layer. Thus, in one example, from the ostomy outwardly 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 middle wall; and a woven front comfort layer. The front comfort layer is provided in two parts, namely a top and a bottom part separated by a slit and overlapping in the area of ​​the slit, so that the comfort layer can be pulled apart at the slit to inspect the contents through the transparent wall. Similarly, the middle layer is provided in two parts, which are (only) bonded to the periphery of the two parts of the comfort layer. In this example, the middle wall appears to avoid fraying of the edges of the comfort layer; avoid visibility of the contents; or contribute to the processability of the (somewhat stretchy) fabric to which it is adhered.

[0006] This extra wall has a number of disadvantages to the bag including: increased complexity of construction, which increases cost; increased bulk, and increased noise in use, as there is another (separate) layer that rustles, making the bag less low profile.

[0007] Other prior art documents also propose the use of woven materials as an option in the comfort layer, for example, US2005 / 0273064 discloses a bag which effectively bonds the bag wall forming the cavity to the comfort layer. Thus, a laminate is proposed comprising a fabric layer, which may be a knitted fabric, a woven fabric or a non-woven fabric, adhered to a film layer by an adhesive layer, which substantially continuously bonds the fabric layer to the film layer. This arrangement, while requiring fewer layers than the Salts Confidence BE product, also has other disadvantages, for example, the typical comfort layer includes areas that are not adhered to the film layer forming the cavity, so that the comfort layer can be pulled aside and the interior inspected, but this is not possible with the bag of US2005 / 0273064 because the comfort layer is substantially continuously bonded to the bag wall.

[0008] WO 2021 / 064409 also mentions a comfort layer comprising at least one fabric layer and at least one film layer, wherein the film layer is optionally pressed onto the at least one fabric layer over the entire area of ​​the at least one fabric layer. No explanation is provided as to which side of the fabric layer the film layer should be provided, nor are any details of the lamination provided. To implement this aspect of the invention, a person skilled in the art may contemplate the use of an intervening adhesive layer between the film and the fabric, as in the laminate of US2005 / 0273064.

[0009] In this context, PCT / GB2021 / 051340 proposes an ostomy bag, which includes a cavity for storing ostomy output; the cavity is defined by a rear wall and a front wall, which are connected at their peripheries and are generally formed of a flexible sheet. In the ostomy bag, a sheet of woven comfort material covers the outer surface of the front wall, and has an EVA hot melt adhesive mesh on the inner surface of the comfort material. Except for the periphery where the comfort material is bonded to the front wall, at least part of the EVA hot melt adhesive mesh is adjacent to, facing, and not bonded to the outer surface of the front wall.

[0010] In PCT / GB2021 / 051340, the hot melt adhesive web comprises a substance and multiple voids in the substance, which is considered to be superior to a "full film" in terms of requiring less material than a full film and avoiding the rustling sound associated with a film.

[0011] However, it has been found that the use of an EVA hot melt adhesive web as disclosed in PCT / GB2021 / 051340 has disadvantages, because when the EVA-coated comfort material is attached to the wall of the cavity at the periphery (P) of the bag (by plastic welding), the hot melt adhesive leaks through the comfort material, such as Fig. 9 As shown, black spots (S) are generated, making the edge of the bag unsightly.

[0012] An object of embodiments of the present invention is to at least partially overcome or alleviate the above problems. Summary of the invention

[0013] In this specification, the term "stomal output" refers to any gas or liquid or solid produced by a person with a stoma / ostomate that can be secreted from or out of the stoma. Stoma output can include stoma gas, stoma liquid and stoma solid.

[0014] In this specification, the term "stoma" refers to an opening in the body. Typically, a stoma is a surgical opening in the torso of the body. In some cases, the term "stoma" also refers to internal tissue, an organ, or a portion thereof exposed by the opening. As a non-limiting example, the internal tissue may be selected from the group consisting of the colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be the end or loop of the small intestine or large intestine.

[0015] In this specification, the term "ostomate" refers to a subject that can use the ostomy bag disclosed herein. Although an ostomate generally refers to a subject with a surgical opening, as used herein, "ostomate" can refer to a subject with a stoma, whether the stoma is created by surgery or other means.

[0016] The term "user" may refer to the ostomate, or another person who assists the ostomate, for example, in emptying stoma output from a cavity.

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

[0018] Beneficially, the ostomy bag of the present disclosure may allow the ostomate to increase the time each ostomy bag is used compared to the ostomy bags of the prior art. This may be achieved, for example, by providing the ostomy bag with an increased cavity volume while maintaining the ostomate's discretion and comfort. Additionally or alternatively, this may also be achieved by providing a device for reliably and hygienically discharging the ostomy output from the cavity, so as to increase the ostomate's confidence in reusing the ostomy bag compared to some prior art bags. Because the ostomate may tend to use each ostomy bag of the present disclosure for a longer period of time, the total number of ostomy bags used by the ostomate in a given time may be reduced. This may produce environmental benefits in terms of reducing the amount of environmental waste generated.

[0019] In this specification, the position and orientation of features may be described with reference to the ostomy bag "in use", "in the orientation in which it is in use", or the like. These terms refer to the intended orientation of the ostomy bag when it is attached to the body of the ostomy when the ostomy is in a standing position, regardless of whether the ostomy bag is currently being used in this way or the actual position of the ostomy. The terms "upper" and "lower" and related terms refer to the relative position of a part or portion of the ostomy bag when in use. For example, a part of the ostomy bag may be referred to as the "upper" section of the ostomy bag. In such an example, when attached to the body of a standing ostomy, the section will be the uppermost section (in the vertical direction) of the ostomy bag. However, those skilled in the art will understand that the section may not always be the uppermost section before being attached to the ostomy, and further, when attached, if the ostomy adopts a non-standing posture, such as lying down, the section may not always be the uppermost section.

[0020] The terms "left side" and "right side" and related terms refer to the side when viewed from the rear (e.g. Figure 1 Thus, as an illustrative example, with the ostomy bag attached to the front torso of an ostomy person, the "left" edge of the ostomy bag would be towards the left hand side of the ostomy person.

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

[0022] In this specification, the terms "front" and "back" refer to the relative position of a component or a part of the ostomy bag with respect to the body of the ostomy person when the ostomy bag is attached to the body. "Back" refers to a position closer to the ostomy person's body than the comparative position / relative position of the so-called "front". "Front" refers to a position farther from the ostomy person's body than the comparative position of the so-called "back".

[0023] In this specification, the term "smooth blending" and related terms refer to the smooth merging of two edges, lines, or contours without abrupt changes in contour.

[0024] In this specification, the term "peripheral / surrounding area" refers to a portion located at or towards the edge of the referred item.

[0025] The term "turning up" as used herein may include folding or rolling up of a component.

[0026] Ostomy bag is attached to the body by ostomy piece usually, and this ostomy piece comprises one or more adhesive layers.Ostomy piece usually has the opening for stoma, and this opening is sometimes called starting hole, and before attachment, the user can cut this opening into required size.Ostomy piece typically includes the adhesive layer on the body-facing side, for adhering ostomy piece to the body of ostomate.Typically, peelable liner covers the body-facing side of ostomy piece, is removed by the user before being attached on the skin.In this manual, term " ostomy piece " can be used interchangeably with term " adapter ", " thin sheet ", " substrate " or " layered adhesive sheet ".In this manual, term " ostomy piece " comprises the ostomy piece for " two-piece bag " and " one-piece bag ".

[0027] In this specification, a "two-piece bag" refers to a bag in which the ostomy disc forms part of a separate body fitting component that is attached to the remainder of the bag by a releasable coupling. The two-piece bag allows the body fitting component to be separated from the bag without damage, so that at least one component can continue to be used in terms of functionality. For example, the body fitting component can remain in place on the body of an ostomate.

[0028] In this specification, a "one-piece bag" refers to a bag in which the ostomy disc is permanently attached to the bag so that the ostomy disc cannot be easily separated without risking the bag being damaged. A one-piece bag is intended to be used as an integral unit.

[0029] Stoma bags are generally configured as closed bags or open bags. In the present specification, a "closed bag" refers to a bag that is not intended to discharge stoma output from the cavity. Therefore, a closed bag can generally be configured as a disposable, disposable and non-reusable bag. In the present specification, an "open bag" refers to a bag for discharging stoma output from the cavity. Therefore, an open bag can be configured as a reusable bag so that it can be reused and emptied multiple times while attached to the body, although this is not required. In an open bag, stoma output can be discharged intermittently under the operation of the ostomist, or can be discharged intermittently or continuously because the cavity is fluidly connected to a drainage tube (e.g., a nighttime drainage tube).

[0030] The present invention provides an ostomy bag. Specifically, the present invention provides an ostomy bag having a sheet of comfort material, which is laminated with a film material layer / film layer across its inner surface. At least a portion of the inner surface may be adjacent to and facing a cavity for storing stoma output, and not combined with the cavity. The cavity may be defined by a rear wall and a front wall, which may be connected at their peripheries and may be formed by a flexible sheet. The comfort material may be woven. 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 bag. The inner surface of the sheet of comfort material may be laminated to the film material layer across its entire surface. The film material layer may be a continuous film material layer. At least a portion of the continuous film material layer may be adjacent to and facing the outer surface of the front wall, and not combined with the outer surface of the front wall.

[0031] According to a broad aspect of the invention, there is provided an ostomy bag comprising a cavity for storing ostomy output; the cavity being defined by a rear wall and a front wall, the rear wall and the front wall being joined at their peripheries and being formed by a flexible sheet; the ostomy bag further comprising a sheet of comfort material covering the outer surface of the front wall; the sheet of comfort material having an outer surface and an opposing inner surface, wherein the outer surface of the sheet of comfort material forms at least a portion of the outer surface of the bag, and the inner surface of the sheet of comfort material is laminated to a continuous film material layer across its entire surface; at least a portion of the continuous film material layer is adjacent to and facing the outer surface of the front wall and is not bonded to the outer surface of the front wall. The comfort material may be a woven material. The continuous film material layer may be laminated to the comfort material without the need for an intermediate adhesive.

[0032] According to a first aspect of the present invention, there is provided an ostomy bag comprising a cavity for storing ostomy output; the cavity being defined by a rear wall and a front wall, the rear wall and the front wall being joined at their peripheries and being formed by a flexible sheet; the ostomy bag further comprising a sheet of woven comfort material covering the outer surface of the front wall; the sheet of comfort material having an outer surface and an opposing inner surface, wherein the outer surface of the sheet of comfort material forms at least a portion of the outer surface of the bag, and the inner surface of the sheet of comfort material is laminated to a continuous film material layer across its entire surface without an adhesive interposed therebetween; at least a portion of the continuous film material layer is adjacent to and facing the outer surface of the front wall, and is not bonded to the outer surface of the front wall.

[0033] Compared with PCT / GB2021 / 051340, the continuous membrane material layer can be understood as an uninterrupted layer, and it can also be understood as a "solid / entity" layer without gaps.

[0034] When the comfort material is welded to the wall of the cavity, this layer of membrane material will not have the same tendency to leak through the woven material - because forming a mesh generally requires spraying technology (spraying onto the comfort material, or spraying into a layer, which is formed into a roll and laminated to the comfort material (as disclosed in PCT / GB2021 / 051340)); therefore, in order to spray, the inventors recognize that the EVA hot melt adhesive must have a relatively low viscosity or other properties that cause problematic leakage of the comfort material. Without being bound by theory, the inventors believe that materials with higher viscosities are less likely to flow through the comfort material and can be easily made into a continuous film; therefore, based on the present disclosure, a person skilled in the art can easily select a continuous film with appropriate properties to avoid this problem.

[0035] Clearly, the ostomy bag of the first aspect of the invention has some advantages over the Salts (RTM) Confidence BE (RTM) product, such as no separate intermediate layer, and therefore less rustling. Furthermore, since the film layer is laminated to the woven comfort material, without an adhesive layer in between, the process of attaching the comfort layer to the cavity is simplified, since the already laminated woven layer can be attached directly to the film forming the cavity, so there are fewer rolls of material that need to be joined during the manufacturing process.

[0036] Of course, the advantages of the present disclosure over US2005 / 0273064 are the same as those over PCT / GB2021 / 051340.

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

[0039] The continuous film material layer may have a thickness of at least 0.5, 1, 5, 10, 15, 16 or 20 g / m 2 and / or not exceeding 500, 100, 50, 40, 35, 30 or 25 g / m 2 The surface density / surface density / area density is preferably 10-50g / m 216-35g / m 2 18-30g / m 2 or 20-25g / m 2 , for example 23g / m 2 .

[0040] Therefore, in a preferred embodiment, there is provided an ostomy bag, which comprises a cavity for storing ostomy output; the cavity is defined by a rear wall and a front wall, the rear wall and the front wall being connected at their peripheries and formed by a flexible sheet; the ostomy bag 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, wherein the outer surface of the sheet of comfort material forms at least a portion of the outer surface of the bag, and the inner surface of the sheet of comfort material is laminated to a continuous film material layer across its entire surface without an adhesive in between; at least a portion of the continuous film material layer is adjacent to and facing the outer surface of the front wall and is not bonded to the outer surface of the front wall; wherein the continuous film material layer has a 18-30 g / m 2 Surface density.

[0041] The continuous film material layer is formed by a material bonded to the material constituting the comfort layer, and no adhesive is required to be interposed therebetween. Like this, the continuous film material layer can be a continuous hot melt adhesive material layer.

[0042] The continuous layer of membrane material may be formed from the same material as the front and rear walls. This improves the attachment of the comfort material to the cavity, as the two materials typically melt at the same temperature during the plastic welding step and bond well to each other.

[0043] The continuous film material layer and the front wall and the rear wall may be formed of a polymer having the same chemical structure. The continuous film material layer and the front wall and the rear wall may be formed of a polymer having the same molecular weight M n The continuous film material layer and the front wall and the rear wall can be made of a polymer having the same melting point M p The continuous membrane material layer and the front and rear walls may be formed from a polymer obtained from the same source and having the same name. The use of polymers obtained from the same source and having the same name should ensure that other features defining similarity (e.g., structure, M n 、M p ) can be considered the same without measurement.

[0044] The continuous film material layer is preferably formed from EVA. Alternatively, the continuous film material layer may be formed from another plastic material such as polyethylene, provided that the film selected has suitable properties and can be bonded to the comfort material without an intermediate adhesive layer and will not leak.

[0045] The bag may have a front portion and a rear portion. The sheet of woven comfort material may form at least a portion of the front surface of the bag. Both the front and rear surfaces of the bag may be formed of the sheet of woven comfort material. Thus, the ostomy bag 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 opposing inner surface, wherein the outer surface of the sheet of comfort material forms at least a portion of the outer surface of the bag, and the inner surface of the sheet of comfort material is laminated to a continuous film material layer across its entire surface; at least a portion of the continuous film material layer is adjacent to and facing the outer surface of the rear wall and is not bonded to the outer surface of the rear wall.

[0046] Thus, this embodiment of the invention provides a bag that is covered on both sides (front and back) with a woven comfort material, which provides enhanced comfort to the user, and which has a continuous layer of film material laminated to a sheet of comfort material, so that the bag can be easily manufactured without the need for additional welding steps or the introduction of intermediate layers, and does not suffer from the problem of adhesive leakage through the comfort layer. In fact, the laminated sheet of comfort material can be bonded to the rest of the bag, such as the front wall defining one side of the cavity and the back wall defining the other side of the cavity, in the same way as nonwoven materials are bonded, typically in a single-step welding process, so that the peripheries of all layers are bonded to each other.

[0047] Woven comfort materials may include natural materials, such as cotton or wool, and / or synthetic materials, such as any one or more of polyester, nylon, viscose, polyethylene, polypropylene, etc. The surface density of the woven material may be 20 to 200 g / m 2 , preferably 40-80g / m 2 , for example 58g / m 2 . The tensile strength of the woven material can be 200 to 400N, preferably 250 to 350N, for example 300N for warp and 280N for weft. The tear strength of the woven material can be 5 to 50N, preferably 10-30N, for example 18N. The color fastness of the woven material to any one or more of friction, perspiration or washing (400) can be 4 to 5. The woven material can have an abrasion of> 50,000. The woven material can have a waterproof coating. For example, it can include a woven polyester with a water-repellent finish. The water-repellent finish can be fluorocarbon-based. The water-repellent finish can be dye heat-set or evaporate heat-set.

[0048] The thickness of the woven comfort layer may be from 50 to 1000 microns, preferably from 60 to 500 microns, more preferably from 75 to 300 microns.

[0049] The back wall and the front wall can be substantially the same shape. The back wall and the front wall can be formed by plastic film. The back wall and / or the front wall can be opaque. The back wall and / or the front wall can be transparent. In particular, at least a portion of the front wall can be transparent. The back wall and / or the front wall can be formed by any one of, for example, polyurethane, polyethylene (PE), polyvinylidene chloride (PVDC) or ethylene-vinyl acetate copolymer (EVA). The back wall and / or the front wall can each have a thickness of 50 to 150 microns. The back wall and / or the front wall can each have a thickness of 75 to 100 microns. The back wall and the front wall can have corresponding inner and outer surfaces. The inner surface of the back wall and the inner surface of the front wall can form the inside of the cavity. The outer surface of the back wall and the outer surface of the front wall can form the outside of the cavity. The woven comfort material sheet can have substantially the same shape as the front wall. A comfort material sheet / the comfort material sheet can be bonded to the outer surface of the cavity wall at the periphery, but not bonded to the wall other than the periphery.

[0050] The sheet of woven comfort material covering the front of the bag may include one or more parts. The sheet of woven comfort material covering the front of the bag may include an upper part and a lower part. The upper part and the lower part may have the same shape as the front wall when they are put together. The upper part may extend from the top edge of the bag to a position of 20-50% of the length from the top downward. The lower part may extend from the bottom edge of the bag to a position of 15-50% of the length from the top downward. An overlapping area may be provided where the upper part and the lower part overlap. The upper part may extend over the lower part (or vice versa) to form an overlap in the overlapping area. The upper part and the lower part may be separated from each other in the overlapping area. When the ostomy bag is used, the overlapping area may extend horizontally. Therefore, particularly in the case where the front wall is formed by a transparent film, the present invention provides a device that allows convenient observation of the contents of the stoma and / or bag when necessary.

[0051] The bag may include a drain tube. In use, the drain tube may be disposed at the bottom of the bag. The drain tube may be formed by the front and rear walls of the bag. The drain tube may be rectangular. The drain tube may be foldable. The drain tube may be folded along its length. The drain tube may be movable between a folded configuration and an expanded configuration. The drain tube may be in a closed state in its folded configuration. The drain tube may be in an open state in its expanded configuration. When open, the drain tube may allow stoma output to leave the cavity of the bag. When closed, the drain tube may prevent stoma output from leaving the cavity of the bag.

[0052] The drain tube may be provided with one or more tuck-in strips. The tuck-in strip or each tuck-in strip may span the width of the drain tube. The tuck-in strip or each tuck-in strip may extend the same distance along the length of the drain tube. The tuck-in strip or each tuck-in strip may provide local rigidity to the drain tube. The tuck-in strip or each tuck-in strip may be formed of polystyrene. The tuck-in strip or each tuck-in strip may define the position and direction of one or more folds of the drain tube. The tuck-in strip or each tuck-in strip may comprise a strip of flexible material attached to the drain tube. The strip of material may have a higher rigidity than the drain tube material. Once attached to the drain tube, the tuck-in strip or each tuck-in strip may have a certain elasticity. Therefore, the tuck-in strip may be squeezed laterally to cause the tuck-in strip to arch, thereby facilitating the opening of the drain tube.

[0053] A tuck-in strip may be provided on the rear wall. The tuck-in strip may be provided adjacent to the bottom end of the drainage tube. The tuck-in strip may be provided on the outer surface of the rear wall. A tuck-in strip may be provided on the front wall. The front wall tuck-in strip may be provided on the outer surface of the front wall. The front wall tuck-in strip may be provided above the rear wall tuck-in strip. The front wall tuck-in strip may be provided midway between the top and bottom ends of the drainage tube. A longitudinal gap may be provided between the upper edge of the rear wall tuck-in strip and the lower edge of the front wall tuck-in strip. The longitudinal gap may define a first folded position of the drainage tube.

[0054] The fastening element may be disposed on the outer surface of the rear wall. The rear fastening element may be disposed above the front gather strip. A longitudinal gap may be provided between the upper edge of the front wall gather strip and the lower edge of the second fastening element. The longitudinal gap may define a folded position of the drainage tube. The rear fastening element may be disposed adjacent to the top end of the drainage tube.

[0055] The closure mechanism for the drainage tube of the ostomy bag can be attached to a sheet of comfort material covering the front of the bag. The closure mechanism can be attached to the outer surface of the comfort material. The closure mechanism can be a closure flap. The closure flap can be welded to the woven comfort material. The welding can be along the top edge of the closure flap. The closure flap can have an outer surface and an inner surface. The inner surface of the closure flap can be adjacent to the outer surface of the comfort material. The closure mechanism can include a front fastening element. The front fastening element can be fastened in conjunction with a rear fastening element. The fastening of the fastening element can close the drainage tube.

[0056] The containment flap may comprise a woven comfort material (optionally comprising a continuous layer of film material). This is desirable because forming the containment flap from the same material as the comfort material makes it more subtle / low profile.

[0057] The front fastening element may be disposed above the rear fastening element. The front fastening element may be disposed adjacent to a bottom edge of the comfort material. A longitudinal gap may be disposed between an upper edge of the rear fastening element and a lower edge of the front fastening element. The longitudinal gap may define a folded position of the drainage tube. The rear fastening element may be disposed adjacent to a top end of the drainage tube.

[0058] The drainage tube can be closed by repeatedly folding the drainage tube upward around the fold line defined by the front and rear gather strips and the front and rear fastening elements. The folded drainage tube can be kept between the woven comfort material and the closure flap. The sides of the closure flap cannot extend beyond the edge of the comfort material. The closure flap can include a tab. The tab can extend beyond the bottom edge of the comfort material. The front and rear fastening elements can have the same size. The front and rear fastening elements may not span the entire width of the drainage tube.

[0059] The drain tube can thus be conveniently closed against the comfort material and secured in place with the closure flap. It is therefore not necessary to fold or secure the drain tube beneath the comfort material, which makes the bag easier to use. The provision of the tab makes deployment of the drain tube easier, as the closure flap can be lifted, allowing access to release fastening elements, including fastening elements that do not span the entire width of the drain tube.

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

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

[0062] Of course, the comfort layer and film material may have any of the features outlined above, such as the materials and / or maximum thickness outlined, which makes the film material layer suitable as a backing for the comfort layer, which should be easily conformable, but not suitable for forming the walls of the cavity.

[0063] Thus, for example, in one embodiment, the comfort material layer is woven. Thus, there is provided a method of forming a comfort layer laminate for attachment to a cavity of an ostomy bag; the method comprising laminating a continuous film material layer directly to a sheet of woven comfort material without an adhesive layer interposed therebetween.

[0064] Naturally, the method should form a material in which the comfort material layer remains continuous, i.e. no voids or pores should be introduced at any step in the method. Thus, in one embodiment, a method of forming a comfort layer laminate is provided, the comfort layer laminate being used to be bonded to the cavity of an ostomy bag; the method comprising laminating a continuous film material layer directly to a sheet of comfort material, without an adhesive layer interposed therebetween, to form a woven comfort material sheet having an outer surface and an opposing inner surface, wherein the inner surface of the sheet of comfort material is laminated across its entire surface to the continuous film material layer, without an adhesive interposed therebetween; the continuous film material layer being an uninterrupted "solid" layer without voids.

[0065] According to a third aspect of the invention, there is provided a method of forming an ostomy bag, the method comprising providing a sheet of comfort material having a continuous film material layer laminated across an entire first surface, and bonding only a portion of the first surface of the sheet of comfort material to an outer surface of a cavity wall of the ostomy bag, such that at least a portion of the continuous film material layer is adjacent to and facing the outer surface of the front wall and is not bonded to the outer surface of the front wall.

[0066] The sheet of comfort material has a continuous layer of film material laminated across the entire first surface, preferably formed in accordance with the second aspect of the invention.

[0067] Similarly, a preferred method of forming an ostomy bag comprises first forming a comfort layer laminate for application to a cavity of an ostomy bag; the method comprises laminating a continuous film material layer directly to a sheet of comfort material without an adhesive layer interposed therebetween to provide a sheet of comfort material having a continuous film material layer laminated across an entire first surface; and then forming the ostomy bag by bonding 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 bag, such that at least a portion of the continuous film material layer is adjacent to and facing the outer surface of the front wall and is not bonded to the outer surface of the front wall.

[0068] The step that continuous membrane material layer is directly laminated on the comfortable material sheet can be separated from the step that the inner surface of weaving comfortable material sheet is attached to the bag wall in terms of material / by law of nature.For example, it can be separated in time, for example, before the inner surface of comfortable material sheet is attached to the wall, at least 5 minutes, 10 minutes, 1 hour, 12 hours or 24 hours are carried out.Alternatively / additionally, the step that continuous membrane material layer is directly laminated on the comfortable material sheet can be separated from the step that the inner surface of weaving comfortable material sheet is attached to the bag wall physically.For example, it can be carried out in separate room, separate building or separate city, county or province.

[0069] Therefore, in one embodiment, a method of forming an ostomy bag is provided, the method comprising first forming a comfort layer laminate for application to a cavity of an ostomy bag; the method comprising laminating a continuous film material layer directly to a comfort material sheet without an adhesive layer in between to provide a comfort material sheet having a continuous film material layer laminated across the entire first surface; and then forming the ostomy bag by bonding only a portion of the first surface of the comfort material sheet to the outer surface of the wall of the cavity of the ostomy bag, such that at least a portion of the continuous film material layer is adjacent to and facing the outer surface of the front wall and is not bonded to the outer surface of the front wall; wherein the step of laminating the continuous film material layer directly to the comfort material sheet is performed separately in time from the step of bonding the inner surface of the woven comfort material sheet to the bag wall, and is performed at least 12 hours before bonding the inner surface of the comfort material sheet to the wall.

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

[0071] Preferably, the cavity is defined by a rear wall and a front wall, which are joined at their peripheries and are formed of a flexible sheet. The method may comprise providing the rear wall and the front wall formed of a flexible sheet and joining them at their peripheries. The method may comprise bonding an inner surface of a sheet of comfort material to a periphery of one or more of the rear wall and / or the front wall of the ostomy bag. The method may comprise simultaneously achieving: joining the front wall and the rear wall of the cavity, and bonding a portion of a first (inner) surface of the sheet of comfort material to at least one wall of the cavity.

[0072] The sheet of comfort material may comprise two or more parts, and the method may comprise arranging the parts of the sheet of comfort material and bonding the parts of the sheet of comfort material to the bag. The bonding of the parts may be performed simultaneously. The bonding may be performed by welding. Thus, the present invention allows complex material arrangements to be applied to the bag in a single manufacturing step, reducing the complexity and cost of production.

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

[0074] According to a fifth aspect of the present invention, there is provided a method for collecting stoma output using an ostomy bag according to any aspect described herein. The method may include attaching the ostomy bag around the stoma of an ostomist. The ostomy bag may be attached around the stoma using a ostomy piece of the bag, wherein the bag comprises a one-piece ostomy bag. Optionally, the method may include attaching the ostomy piece of a body fitting part of a two-piece ostomy bag around the stoma; and attaching the bag to the body fitting part. The bag may be attached to the body attachment part before or after the ostomy piece has been attached around the stoma. In the case where the ostomy bag comprises an open bag or a drainable bag, the method may include draining the ostomy output from the ostomy bag.

[0075] Likewise, the fifth aspect of the present invention may include any optional features associated with any one of the first to fourth aspects of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0076] In order that the present invention may be more clearly understood, one or more embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0077] Figure 1 This is a rear view of the ostomy bag.

[0078] Figure 2 yes Figure 1 Front view of an ostomy bag.

[0079] Figure 3 yes Figure 1 A cut-away side view of an ostomy bag.

[0080] Figure 4 This is a front view of another type of ostomy bag.

[0081] Figure 5 yes Figure 4 A cut-away side view of an ostomy bag.

[0082] Figure 6 yes Figure 4 An exploded perspective view of an ostomy bag.

[0083] Figure 7 is a side view of an apparatus for producing ostomy bags.

[0084] Figure 8 is based on Figure 1-8 A partial view of an ostomy bag of any embodiment of the present invention, showing that the laminated film layer does not leak through the woven comfort material in the area where the comfort material is bonded to the cavity; and

[0085] Fig. 9is a partial view of an ostomy bag with a comfort material layer manufactured according to prior art methods, showing leakage of hot melt adhesive through the woven comfort material in the area where the comfort material is bonded to the cavity. DETAILED DESCRIPTION

[0086] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by readers in the field to which the claimed subject matter belongs. It should be understood that the foregoing summary and the following examples of the present disclosure are exemplary and explanatory only and are not intended to limit any subject matter claimed.

[0087] 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 claimed in the appended claims. Many modifications, improvements, and equivalents not explicitly 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.

[0088] In this specification, the use of the singular includes the plural, unless the context clearly dictates otherwise. In this application, the use of "or" means "and / or" unless otherwise stated. In addition, the use of the term "includes" and other forms, such as "have", "includes" and "including", are not limiting.

[0089] As used herein, ranges and amounts may be expressed as "about" a particular value or range. About also includes exact amounts. For example, "about 5 millimeters" means "about 5 millimeters" and may also be "5 millimeters." In general, the term "about" includes amounts that are expected to be within the range of experimental error. The term "about" includes values ​​that fall within the range of 5% less than the provided value to 5% greater than the provided value. For example, "about 30 millimeters" means "between 28.5 millimeters and 31.5 millimeters."

[0090] Reference Figures 1 to 3 , shows an embodiment of the present invention, wherein the ostomy bag 1 comprises a rear wall 2, a front wall 3, a partition wall 4, a rear comfort layer 5, a front comfort layer 6 and a stoma piece 7. In other embodiments within the scope of the claimed invention, one or more of the partition wall 4, the rear comfort layer 5 and the front comfort layer 6 may be omitted if necessary.

[0091] In this embodiment, the ostomy bag 1 is a one-piece bag, wherein the ostomy flap 7 is permanently attached to the ostomy bag 1 (in a sense that the ostomy bag cannot be easily removed and reattached without damaging the bag). However, other embodiments may be two-piece bags, including a bag component and a body fitting component that together form the ostomy bag. In some of these embodiments, the bag includes a rear wall 2, a front wall 3, a dividing wall 4, a rear comfort layer 5 and a front comfort layer 6, and the body fitting component includes the ostomy flap 7.

[0092] The back wall 2 and the front wall 3 define a cavity for accommodating stoma output. In this embodiment, the back wall 2 and the front wall 3 are both formed by a flexible sheet in the form of a plastic film and are joined together to define the cavity. An exemplary film is ethylene-vinyl acetate copolymer (EVA). The film typically has a thickness of 75 to 100 microns, but in some embodiments may have a thickness of 50 to 150 microns.

[0093] In this embodiment, the ostomy bag 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.

[0094] In this embodiment, when viewed from the rear, the ostomy bag 1 has a left side 13 and a right side 14. The waist section 12 has a left side edge 13c and a right side edge 14c, both of which are smoothly rounded and merge into the left side edges 13a, 13b and the right side edges 14a, 14b of the upper section 10 and the lower section 11, respectively.

[0095] The shape and size of the ostomy bag 1 are not particularly limited as long as it remains inconspicuous and comfortable to wear during use. Exemplary sizes and other suitable shapes are described in the prior art documents cited in the background technology, such as PCT / GB2021 / 051340, which is incorporated herein by reference.

[0096] In this embodiment, the left-hand edge 13c and the right-hand edge 14c of the waist section 12 have a concave curvature with a radius of curvature r1.

[0097] In this embodiment, both the upper section 10 and the lower section 11 are circular 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 a radius of curvature of r2 and r3, respectively. In this embodiment, r2 and r3 are constant along their respective edges 15, 16, however, in alternative embodiments, they may be variable.

[0098] In this embodiment, the upper section edge 15 includes the left side edge 13a and the right side edge 14a of the upper section 10, while the lower section edge 16 includes the corresponding left side edge 13b and right side edge 14b of the lower section.

[0099] In this embodiment, the junction between the upper section 10 and the waist section 12 may be demarcated 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 junction between the lower section 11 and the waist section 12 may be demarcated 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.

[0100] The rear wall 2 and the front wall 3 are joined around their peripheral edges using welding. Welding is the preferred method of joining the rear wall 2 and the front wall 3 as it allows all layers of the bag 1 to be joined simultaneously as described below.

[0101] In this embodiment, the rear wall 2 and the front wall 3 are joined together by a single continuous edge seal 8 which extends around the entire periphery of the rear wall 2 and the front wall 3 to form a fluid tight seal.

[0102] The rear wall 2 is provided with a stoma inlet 20 for receiving stoma output into the cavity. The stoma inlet 20 is a hole cut in the rear wall 2 in the upper section 10 of the ostomy bag 1, wherein a sheet 7 is provided having a hole through which the stoma typically extends.

[0103] In this embodiment, the rear comfort layer 5 and the front comfort layer 6 have 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 exterior of the ostomy bag 1 and cover the rear wall 2 and the front wall 3, respectively. The rear comfort layer 5 further comprises a sheet hole which is aligned with the stoma entrance 20 of the rear wall 2, wherein the sheet 7 is arranged in the sheet hole.

[0104] The rear comfort layer 5 and the front comfort layer 6 are formed by a flexible sheet material comprising a woven fabric layer laminated to a continuous membrane material layer across its entire surface. The continuous membrane material layer forms an uninterrupted solid layer without gaps, thereby completely covering one surface of the comfort layer 6, i.e., its inner surface when in use.

[0105] In this embodiment, the fabric layers form the outer surfaces of the rear comfort layer 5 and the front comfort layer 6, respectively, and the continuous film material layer is arranged on the corresponding inner surfaces, facing the rear wall 2 and the front wall 3. Other embodiments may include additional fabric layers and / or film layers as required. In this embodiment, the woven fabric layer includes polyester, but in other embodiments, any one or more of nylon, viscose fiber, polyethylene and polypropylene may be used in addition or as an alternative.

[0106] In this embodiment, the woven fabric layer has a thickness of 58 g / m 2 The surface density of the fiber is 280 to 300 N, the tensile strength is 280 to 300 N, and the tear strength is 18 N. Other embodiments may have different compositions, such as 50 to 70 g / m 2 The invention also provides a woven polyester / polyester with a surface density of 1000N, a tensile strength of 200 to 400N, and a tear strength of 10 to 30N. Some embodiments may also have a color fastness of 4 to 5 for any one or more of friction, perspiration or washing (400), and an abrasion of >50,000. Certain embodiments also include a woven polyester / polyester with a water repellent finish. The water repellent finish may be fluorocarbon based and may be dye heat set or evaporate heat set. A suitable woven polyester layer is available from Newton Weaving Co., Ltd. of Northamptonshire, England under the name 75DCWR, for example 75DCWR WHITE (for white variant).

[0107] In this embodiment, the continuous film material layer comprises ethylene vinyl acetate (EVA).

[0108] In this embodiment, the continuous film material layer has a thickness of 23 g / m 2 A suitable EVA film is available from Protechnic SA of Cernay, France, under the name 3X9S23.

[0109] The continuous film material layer is laminated to the fabric layer over the entire area of ​​the inner surface of the rear comfort layer 5 and the front comfort layer 6. Lamination - for example calendering at elevated temperature and pressure - produces a laminate in which the continuous film material layer extends across the entire area of ​​the comfort layers 5, 6, has a uniform thickness and has no voids therein. Because the EVA film in question is tacky at elevated temperatures, there is no adhesive layer between the continuous film and the comfort layer, but the continuous film material layer is laminated directly to the comfort layer.

[0110] Advantageously, the provision of a continuous film material layer allows the comfort layers 5, 6 and walls 2, 3 to be simultaneously joined together in the same welding process when necessary in the same manner as the attachment of nonwoven materials, improving the bond without the need for a dedicated intermediate layer and without the need to apply adhesives during the construction process. In this embodiment, the peripheral weld defined by the edge seal 8 also 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, a weld may correspond only to a portion of the weld joining the rear wall 2 and the front wall 3. The weld attaching the rear comfort layer 5 to the rear wall 2 may be different from the weld attaching the front comfort layer 6 to the front wall 3. In addition, the continuous film material layer protects the fabric layer from unwanted wear.

[0111] In this embodiment, the front comfort layer 6 comprises an upper portion 6a and a lower portion 6b, which when combined have the same shape as the front wall 3. The upper portion 6a extends from the top of the bag 1 to the inflection point 17 between the upper section 10 and the waist section 12. The lower portion 6b extends from the bottom of the bag 1, below the upper portion 6a, to a point slightly above the inflection point 17. In this way, the upper portion 6a partially overlaps the lower portion 6b in the overlap area 115. The upper portion 6a and the lower portion 6b can be separated from each other in the overlap area 115 to form a window for observing the cavity. When the ostomy bag 1 is used, the overlap area 115 extends horizontally. In some embodiments, the overlap area 115 may not coincide with the inflection point 17 and may span the bag 1 at any suitable position along the length of the bag 1. Importantly, if there is no continuous film material layer, regardless of the material selection of the walls 2, 3, the two parts 6a, 6b of the front comfort layer 6 will not be bonded to each other at all, because the material of the walls does not participate in the bonding in this area.

[0112] In other embodiments, the front layer may be composed of multiple parts. The outer shape and size of the multiple parts together may be the same as that of the front wall 3.

[0113] In this embodiment, the stoma flap 7 is aligned with the stoma entrance 20 of the rear wall 2 and extends through the flap hole of the rear comfort layer 5. The stoma flap 7 includes an adhesive and a peelable liner 31. The stoma flap 7 is mounted to the rear wall 2 by welding. In other embodiments, the flap 7 can be mounted by any suitable alternative means (e.g., adhesive).

[0114] The ostomy bag 1 may also be provided with an exhaust port for exhausting stoma gases from the cavity. In this embodiment, the ostomy bag 1 comprises an exhaust filter 24, which is also an odour filter. A suitable filter may be a charcoal or activated carbon filter for reducing the release of unwanted odours from the cavity. The exhaust filter 24 forms part of the exhaust port, which comprises an exhaust hole 27 located in the front wall 3. In some embodiments, the exhaust filter 24 is covered by a filter cover, and the exhaust filter 24 and the filter cover are located on the front wall 3 above the exhaust hole 27. The exhaust hole 27 allows gas to flow from the cavity to the outside of the ostomy bag through the exhaust filter 24 and the filter cover.

[0115] In this embodiment, when in use, the vent is located at the upper quarter of the ostomy bag 1. Specifically, when in use, the center of the vent hole 27 is arranged above the center of the stoma entrance 20. In other embodiments, the vent can be located at other positions of the upper section 10 of the ostomy bag 1.

[0116] In this embodiment, the partition wall 4 is located between the rear wall 2 and the front wall 3. The partition wall 4 includes 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 exhaust port and blocking or impairing the function of the exhaust filter 24.

[0117] In this embodiment, the partition wall 4 has the same outer shape and size as the rear wall 2 and the front wall 3, and divides the cavity of the ostomy bag 1 into a first chamber 101 and a second chamber 102. The first chamber 101 extends between the partition wall 4 and the rear wall 2, and the second chamber 102 extends between the partition 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.

[0118] In this embodiment, the partition wall 4 is joined to the rear wall 2 and the front wall 3 by welding at the peripheral edges of the rear wall 2 and the front wall 3 to create a fluid tight seal between them. In another embodiment, the partition wall 4 is joined to the rear wall 2 and the front wall 3 around the entire edge of the upper section 10, and is additionally joined to the front wall 3 by horizontal welding at the interface between the upper section 10 and the waist section 12. Therefore, according to some embodiments of the present invention, the joining of the partition wall 4 to the rear wall 2 and the front wall 3 can make the first chamber 101 and the second chamber 102 sealed from each other except by the separation filter 100.

[0119] In this embodiment, the partition wall 4 includes a flexible sheet material, which can be formed by polyurethane, polyethylene (PE), polyvinylidene chloride (PVDC) and / or ethylene-vinyl acetate copolymer (EVA). In certain embodiments, the flexible sheet material of the partition wall 4 has a thickness of 50 to 150 microns, preferably 75 to 100 microns. In this embodiment, the partition wall 4 includes a hydrophobic coating and an oleophobic coating applied to the flexible sheet material. In other embodiments, the flexible sheet material can be hydrophobic and / or oleophobic.

[0120] Reference Figures 4 to 6 Another embodiment of the ostomy bag 201 according to the present invention is Figures 1 to 3 The illustrated embodiment is similar and similar features have similar reference numerals, only increased by 200. The main difference is that the lower section 211 of the other embodiment is shaped to accommodate / form a collapsible drainage tube. Thus, in contrast to the above-described embodiment, this embodiment of the ostomy bag 201 is an open bag that does not include a sealed perimeter.

[0121] Furthermore, in this embodiment, no partition wall is provided between the front wall 203 and the rear wall 202, so that the cavity is not divided into two sections. The rear wall 202 has a large opening 202i aligned with the stoma inlet 207i of the sheet 207 (which is connected to the rear wall 202 in the area between the periphery of the opening 202i and the periphery of the sheet, so that the stoma output enters the cavity via the stoma inlet of the sheet and the opening 202i in the rear wall. The rear comfort layer 205 also has an opening 205i slightly larger than and aligned with the opening 202i in the rear wall 202, so as to be sandwiched between the outermost edge of the sheet and the rear wall 202. The stoma inlet 207i is adjustable to fit the stoma of the ostomate.

[0122] In a manner similar to the first embodiment, the front comfort layer 206 of this embodiment is formed of two parts: an upper part 206a; and a lower part 206b. The upper part 206a overlaps the lower part 206b across most of the width of the bag 201 at a point at a height aligned with the stoma entrance 207i. The overlap is defined by the lower edge 231 of the upper part 206a overlapping the upper edge 232 of the lower part 206b.

[0123] In this embodiment, there is also an optional gas filter 224 located in the front wall 203 at a height above the stoma entrance 207i to allow gas to leave the bag 201. In this embodiment, the filter 224 is covered by an optional filter cover patch 225 ( Figure 5 In this way, the filter 224 and the filter covering patch 225 are covered by the upper part 206a of the front comfort layer 206.

[0124] In this embodiment, the lower section 211 includes a drainage hole 40. The drainage hole 40 is an unsealed portion of the periphery of the ostomy bag 201 where the rear wall 202 and the front wall 203 are not sealed.

[0125] In this embodiment, the lower section 211 includes a circular portion 211a adjacent to the waist section 212 and a generally rectangular drainage portion 41 accommodating the drainage holes 40. The drainage portion 41 is foldable along its length between expanded and folded configurations, as described below.

[0126] In this embodiment, the lower section 211 includes a continuous left edge 42 extending from the left edge 213c of the waist section 212 to the left vertex 44 of the drainage hole 40, around the curved left edge 42c of the generally circular portion 211a and along the left edge 42d of the drainage portion 41. Similarly, the continuous right side edge 43 extends from the right edge 214c of the waist section 212 to the right vertex 45 of the drainage hole 40, around the continuously curved right edge 43c of the generally circular portion 211a and along the right edge 43d of the drainage portion 41. (Note that due to Figure 4 It is a front view, the left edge of bag 1 is on the right side of the figure, and the right edge of bag 1 is on the left side of the figure. )

[0127] The left edge 42d and the right edge 43d of the drainage portion 41 are parallel to each other along most of their lengths.

[0128] In this embodiment, a single continuous edge seal 208 extends around the perimeter of the bag 201 from the left apex 44 of the drainage hole 40 to the right apex 45 of the drainage hole 40 , leaving the distal end of the drainage hole 40 open.

[0129] In this embodiment, the drainage portion 41 defines an elongated drainage channel extending from the cavity of the ostomy bag 201 to the drainage hole 40 located at the lower end of the drainage portion 41. The drainage portion 41 is integral with the lower section 211, and therefore, the rear wall 202 and the front wall 203 can be a single piece of material including the upper section 210, the waist section 212 and the lower section 211 (including the drainage portion 41). However, in this embodiment, the rear comfort layer 205 and the front comfort layer 206 do not cover the drainage portion 41 of the rear wall 202 and the front wall 203.

[0130] In this embodiment, communication between the cavity and the elongated drainage channel is achieved through a drainage inlet 200, which is defined as a transition point between the cavity and the drainage portion 41. The drainage inlet 200 allows stoma output to enter the drainage portion 41 from the cavity when the drainage portion 41 is deployed.

[0131] In this embodiment, movement of the drainage portion 41 between its expanded or folded configuration opens or closes the drainage hole 40. This either allows or prevents the outflow of stoma output stored in the cavity of the ostomy bag 1.

[0132] In this embodiment, the drainage portion 41 can be repeatedly folded in the same manner along its length into multiple sections, which have approximately equal section lengths and are separated by folds. Therefore, the drainage portion 41 can be folded one or more times in succession so that the sections overlap each other. Each fold is formed across the width of the drainage portion 41 and is used to inhibit and preferably prevent stoma output from passing through the drainage hole 40.

[0133] In this embodiment, a first tuck-in strip 221 and a second tuck-in strip 222 are disposed on the drainage portion 41. The tuck-in strips 221, 222 provide local rigidity to the drainage portion 41 and also define the positions and directions of the sections and folds of the drainage portion 41. The tuck-in strips 221, 222 comprise strips of flexible material attached to the drainage portion 41, wherein the tuck-in strips 221, 222 have a higher rigidity than the material of the drainage portion 41. The tuck-in strips 221, 222 also have some elasticity, so that once attached to the drainage portion 41, the tuck-in strips 221, 222 can each be laterally squeezed to make the tuck-in strips arched, thereby opening an elongated drainage channel. In other embodiments, two or more tuck-in strips may be used.

[0134] In this embodiment, the gather strips 221, 222 are formed from polystyrene, but other embodiments may include any suitable material.

[0135] In this embodiment, a first tuck strip 221 is attached to the rear wall 202 of the drainage portion 41 adjacent to the drainage hole 40. A second tuck strip 222 is attached to the front wall 203 of the drainage portion 41 above the second tuck strip 222. A longitudinal gap is provided between the upper edge of the first tuck strip 221 and the lower edge of the second tuck strip 222. Thus, the longitudinal gap defines the location of the first fold of the drainage portion 41. Each tuck strip 221, 222 spans the width of the drainage portion 41 and extends the same distance along the length of the drainage portion 41.

[0136] In this embodiment, the rear fastening element 215a is arranged on the rear wall 202, and the front fastening element 215b is arranged on the wing 223 mounted to the front comfort layer 206. In this example of a two-part front comfort layer 206, the wing 223 is mounted to the lower part 206b of the comfort layer 206. The rear fastening element 215a and the front fastening element 215b include corresponding hook and loop type fastening elements. The rear fastening element 215a is located on the drainage portion 41 above the second gathering strip 222. A longitudinal gap is provided between the upper edge of the second gathering strip 222 and the lower edge of the rear fastening element 215a. Therefore, the longitudinal gap defines the position of the second fold of the drainage portion 41.

[0137] In this embodiment, the flap 223 includes a first flange 223a and a second flange 223b formed from one integral piece. The first flange 223a substantially spans the entire width of the lower circular segment 211a, but does not extend over the edge seal 208, extending from the inlet 200 at a position one-third of the length of the circular segment 211a. The first flange 223a is attached to the comfort material 206 by a single weld that substantially spans its entire width.

[0138] The wing 223 can be formed by the same material as the comfort layer, that is, the woven comfort material sheet, and a continuous film material layer is laminated on its inner surface. Like this, the welding between the outer surface of the comfort layer 206b and the wing 223 can be realized by the continuous film material layer forming the inner surface of the woven comfort material sheet. The second flange 223b extends from the lower edge of the first flange 223a, and is only connected to the bag 1 by the first flange 223a. The profile of the second flange 223b meets the shape of the circular portion 211a, but is thinner, following the inner edge of the peripheral weld 208. Like this, the second flange 223b extends downwards from the first flange 223a in the perimeter limited by the edge seal 208 of the bag 201.

[0139] In this embodiment, the flap 223 has an outer surface and an opposite inner surface that are away from the ostomate when in use. The front fastening element 215b is located on the inner surface of the second flange 223b at a position above the rear fastening element 215a. The longitudinal gap is arranged between the upper edge of the rear fastening element 215a and the lower edge of the front fastening element 215b, and defines the position of the third fold of the drainage portion 41. The flap 223 is formed by a flexible sheet that is more rigid than the flexible sheet of the rear wall 202, the front wall 203 and the comfort layer 205, 206. In this embodiment, the flap 223 is formed by a plastic foam that provides the required rigidity.

[0140] The folding of the drainage portion 41 can be performed as follows. First, the distal end of the drainage portion 41 is folded upward and away from the rear of the ostomy bag 201 around the first folding line to position the first tuck-in strip 221 on the second tuck-in strip 222. Secondly, the drainage portion 41 and the tuck-in strips 221, 222 are folded around the second folding line again in the same manner, and then folded around the third folding line, so that the folded and stacked first tuck-in strip 221, the second tuck-in strip 222 and the first fastening element 215a are located below the second flange 223b of the flap 223, and the rear fastening element 215a is exposed and adjacent to the front fastening element 215b. Finally, the second flange 223b of the flap 223 is pressed onto the folded drainage portion to fix the rear fastening element 215a and the front fastening element 215b together.

[0141] In these embodiments, the drainage portion 41 may then be deployed by reversing the above process.

[0142] As in the first embodiment, in the second embodiment, the rear comfort layer 205 and the front comfort layer 206 are formed by a flexible sheet material, which includes a woven fabric layer, which has a continuous film material layer laminated to one surface (its inner surface) in use. In this embodiment, the fabric layers form the outer surfaces of the rear comfort layer 205 and the front comfort layer 206, respectively, and the continuous film material layer is arranged on the corresponding inner surface, facing the rear wall 202 and the front wall 203. Other embodiments may include additional fabric layers and / or film layers as needed. In this embodiment, the woven fabric layer includes polyester, but in other embodiments, any one or more of nylon, viscose fiber, polyethylene and polypropylene can be used in addition or as an alternative.

[0143] In this embodiment, the woven fabric layer has a thickness of 58 g / m 2 The surface density of the fiber is 280 to 300 N, the tensile strength is 280 to 300 N, and the tear strength is 18 N. Other embodiments may have different compositions, such as 50 to 70 g / m 2 The invention also provides a woven polyester having a surface density of 100 to 200 N, a tensile strength of 200 to 400 N, and a tear strength of 10 to 30 N. Some embodiments may also have a color fastness of 4 to 5 for any one or more of friction, perspiration or washing (40 °), and a wear of >50,000. Certain embodiments also include a woven polyester with a water repellent finish. The water repellent finish may be fluorocarbon based and may be dye heat set or evaporate heat set. Suitable woven polyester layers are available from Newton Weaving Co., Ltd., Northamptonshire, UK, under the name 75DCWR, for example 75DCWR WHITE (for white variants).

[0144] In this embodiment, the continuous film material layer has a thickness of 23 g / m 2A suitable EVA film is commercially available from Protechnic SA of Cernay, France, under the name 3X9S23.

[0145] In this embodiment, the continuous layer of membrane material is again laminated directly to the fabric layer over the entire area of ​​the inner surface of the rear comfort layer 205 and the front comfort layer 206, without the need for an intermediate adhesive because the membrane layer itself is tacky at elevated temperatures.

[0146] Advantageously, as in the first embodiment, the use of a continuous film material layer allows the comfort layer 205, 206 and the two walls 202, 203 to be simultaneously joined together in the same welding process in the same manner as the attachment of the nonwoven material when necessary, without the need for a special intermediate layer, and without the need to use adhesives during the construction process, even in the area where the woven layers are joined to each other (i.e., the overlapping parts). In this embodiment, the peripheral welding defined by the edge seal 208 also 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 weldings can be used as needed or desired. For example, welding can correspond only to a part of the welding that joins the rear wall 202 and the front wall 203. The welding of the rear comfort layer 205 attached to the rear wall 202 can be different from the welding of the front comfort layer 206 attached to the front wall 203.

[0147] Reference Figure 7 , schematically shows an apparatus for forming a bag of the present invention. In this embodiment, the apparatus 300 includes four rollers 301, 302, 303 and 304, a stamping / embossing welder 305 and a cutter 306. The rollers 301, 302, 303, 304 are used to advance a first flexible sheet 311, a second flexible sheet 312, a third flexible sheet 313 and a fourth flexible sheet 314 in the direction of arrow D, respectively. For simplicity, additional rollers for advancing the sheets are not shown.

[0148] In this embodiment, the device 300 is configured to construct a Figures 1 to 6 The ostomy bag 310 of the ostomy bag 1, 201 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, the process is simplified and shown without features such as the separation layer 4 or the drainage portion 41 described in the above embodiments, and without any description of the assembly of the sheets, filters, etc., which can be provided in a manner known to those skilled in the art.

[0149] The first sheet 311 and the second sheet 312 are plastic films for the rear and front walls, respectively, of the bag 310. The materials used for these sheets are therefore the same and correspond to the materials described in relation to the ostomy bags 1, 201 above.

[0150] In this embodiment, the third sheet 313 and the fourth sheet 314 are used for the rear comfort layer and the front comfort layer of the bag 310, respectively. As described above, the material for the comfort layer includes a woven fabric layer with a continuous film material layer laminated thereon. Thus, the third sheet 313 and the fourth sheet 314 include woven fabric layers 313a, 314a, each of which has a continuous film material layer 313b, 314b laminated thereto. Figure 7 In the embodiment, the film material layers 313b, 314b face each other, and the first sheet material layer 311 and the second sheet material layer 312 to form the rear wall and the front wall of the cavity are arranged therebetween.

[0151] A few days ago, the third sheet 313 and the fourth sheet 314 had been preformed in a separate device by a lamination process such as a calendering process, wherein thin but solid EVA film sheets 313b, 314b (without gaps therein) were advanced from a roller and directly laminated to woven material sheets 313a, 313b similarly advanced from a roller under elevated heat and pressure, then cooled and wound onto a new roller, and transported on a new roller. As described above, there is no adhesive interposed between the solid EVA film sheet and the woven material sheet. This process produces a continuous EVA film layer with uniform thickness over the entire surface of the woven material, and avoids forming any gaps in the continuous EVA film layers 313b, 314b. For example, using an EVA film laminate named 3X9S23 available from Protechnic SA of Cernay, France, on a woven comfort material, the entire surface can be covered with the laminate, and the thickness of the EVA film can remain essentially unchanged from its initial thickness, which is a constant 23.2 μm = / -1 μm (23.2 μm ± 1 μm) across its entire length and width.

[0152] In this embodiment, the stamping welder 305 is arranged to weld the material layers together using hot stamping. The shape of the weld corresponds to Figures 1 to 3 and Figures 4 to 6 The peripheral edge sealing portion 8 described in the ostomy bag 1, 201.

[0153] from Figure 8 As can be seen in (photograph of sheet 313 / 314 in the area of ​​peripheral edge seal 315, 8, 208), the area that has been welded is virtually indistinguishable from the remainder of the woven material sheet 313, 314. This can be visually distinguished from Fig. 9 In the image comparison, Fig. 9 In the figure, the weld perimeter (P) is clearly discernible as its mottled edge has unsightly black spots (S) (not all are shown).

[0154] Return to reference Figure 7 , in this embodiment, the cutter 306 is arranged to cut sections of the advancing sheet of material in a shape defined by the perimeter of the ostomy bag.

[0155] In this embodiment, first, the first sheet 311 and the second sheet 312 are brought together by a roller (not shown) so that they contact and advance at the same speed as each other. Next, the third comfortable sheet 313 and the fourth comfortable sheet 314 are brought together by rollers (not shown) on the opposite sides of the first film sheet 311 and the second film sheet 312. The third sheet 313 is brought near the first sheet 311 so that the continuous film material layer 313b faces the first sheet 311. Similarly, the fourth sheet 314 is brought near the second sheet 213 so that the continuous film material layer 314b faces the second sheet 312. In this way, all four sheets are in contact and advance at the same speed. Therefore, the sheets are stacked in the following order: the third sheet 313; the first sheet 311; the second sheet 312; and the fourth sheet 314.

[0156] In this embodiment, the advancing sheet then enters a coining welder 305. The coining welder 305 applies a heated pressing to the advancing sheet, producing a sealing weld line 315 corresponding to the perimeter of the ostomy bag 310. The heated pressing can be applied to the comfort layer that is located at the rear when in use, as well as the comfort layer that is located at the front when in use, because direct heating will not cause the continuous film material layer to leak out of the fabric layer, nor will it cause unsightly spots / stains. This is in contrast to the method of PCT / GB2021 / 051340, in which, despite rigorous testing of various different EVA meshes, no fabric was found to be leak-proof, at least on one side.

[0157] The continuous film material layers 313b and 314b facilitate welding of the fabric layers 313a and 314a to the first layer 311 and the second layer 312 - particularly if the continuous film material layers 313b, 314b are formed of the same material as the first layer 311 and the second layer 312, such as when they are both EVA. This process produces a series of sealed ostomy bags 310 in the advancing sheet. In this embodiment, the stamping machine welds only around the perimeter of the bag, leaving a cavity within the bag 310.

[0158] In this embodiment, the advancing sheet then enters a cutter 306. The cutter cuts around the perimeter of the sealing weld line 315 created by the embossing machine 305. This releases each ostomy bag 310 from the advancing sheet where they can be collected or further prepared. Welding and cutting can of course be performed simultaneously.

[0159] In other embodiments, additional layers of material may be introduced. In one embodiment, a fifth sheet of comfort layer material (not shown) is used and is applied to the same side of the bag as the third sheet of comfort layer material 313. This allows the front comfort layer to consist of an upper portion 6a and a lower portion 6b or 6bi, as described above with respect to Figures 1 to 3 Described, wherein for example the third layer forms the lower part and the fifth layer forms the upper part. Advantageously, the third layer 313 and the fifth layer can be welded to the bag at the same time as the other layers, forming a bag with an overlapping area 115 in a single embossing welding process.

[0160] One or more embodiments have been described above by way of example only. Many variations are possible without departing from the scope of protection provided by the appended claims.

Claims

1. An ostomy bag comprising a cavity for storing ostomy output; The cavity is defined by a rear wall and a front wall, the rear wall and the front wall being joined at their perimeters and formed of a flexible sheet material; The ostomy bag also includes 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 opposing inner surface, wherein: the outer surface of the sheet of comfort material forming at least a portion of the outer surface of the bag, and the inner surface of the sheet of comfort material being laminated across its entire surface to the continuous layer of film material without an intervening adhesive; At least a portion of the continuous layer of film material is adjacent to and facing the outer surface of the front wall, and the at least a portion of the continuous layer of film material is not bonded to the outer surface of the front wall.

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

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

4. The ostomy bag according to claim 3, wherein: The continuous layer of membrane material has a thickness of less than 30 microns across the entire surface of the sheet of woven comfort material.

5. The ostomy bag according to claim 4, wherein: The continuous membrane material layer has a thickness of 20 to 25 microns across the entire surface of the woven comfort material sheet.

6. An ostomy bag according to any one of the preceding claims, wherein The continuous film material layer has a thickness of 18-30 g / m 2 Surface density.

7. An ostomy bag according to any one of the preceding claims, wherein The continuous layer of membrane material is formed from the same material as the front and rear walls.

8. An ostomy bag according to any one of the preceding claims, wherein The continuous layer of membrane material and the front and rear walls are formed from a polymer having the same chemical structure.

9. An ostomy bag according to any one of the preceding claims, wherein The continuous membrane material layer and the front wall and the rear wall are composed of the same molecular weight M n of polymer formation.

10. An ostomy bag according to any one of the preceding claims, wherein The continuous film material layer and the front wall and the rear wall are made of materials having the same melting point M p of polymer formation.

11. An ostomy bag according to any one of the preceding claims, wherein The continuous layer of membrane material and the front and rear walls are formed from a polymer obtained from the same source and having the same name.

12. An ostomy bag according to any one of the preceding claims, wherein The continuous film material layer is formed from EVA.

13. The ostomy bag according to claim 12, wherein: The front and rear walls are formed from EVA.

14. An ostomy bag according to any one of the preceding claims, wherein The continuous film material layer has a thickness of at least 5 g / m 2 And not more than 50g / m 2 Surface density.

15. A method of forming a comfort layer laminate for attachment to a cavity of an ostomy bag; the method comprising laminating a continuous layer of film material directly to a sheet of woven comfort material without an intervening adhesive layer.

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

17. The method according to claim 15 or 16, wherein: The continuous membrane material layer has a uniform thickness across the entire surface of the woven comfort material sheet, the thickness across the entire surface of the woven comfort material sheet being between 20 microns and 30 microns; wherein the continuous membrane material layer has a 18-30 g / m 2 and the continuous film material layer and the front wall and the rear wall are formed of EVA.

18. A method of forming an ostomy bag, the method comprising: providing a sheet of comfort material having a continuous film material layer laminated across an entire first surface, and bonding only a portion of the first surface of the comfort material sheet to an outer surface of a cavity wall of the ostomy bag, such that at least a portion of the continuous film material layer is adjacent to and facing the outer surface of the front wall and is not bonded to the outer surface of the front wall.

19. A method of forming an ostomy bag, the method comprising: First forming a comfort layer laminate for application to the cavity of an ostomy bag; the method comprising laminating a continuous film material layer directly to a sheet of comfort material without an adhesive layer interposed therebetween, such that the sheet of comfort material has a continuous film material layer laminated across the entire first surface; The ostomy bag is then formed by bonding only a portion of the first surface of the comfort material sheet to the outer surface of the cavity wall of the ostomy bag such that at least a portion of the continuous film material layer is adjacent and facing the outer surface of the front wall and is unbonded thereto.

20. The method according to claim 19, wherein: The step of laminating the continuous film material layer directly to the comfort material sheet is separated in time from the step of bonding the inner surface of the comfort material sheet to the bag wall, at least 12 hours before bonding the inner surface of the comfort material sheet to the bag wall.

21. The method according to any one of claims 18 to 20, wherein: The method comprises bonding a first surface of a sheet of comfort material to a periphery of a cavity wall of an ostomy bag by welding.

22. The method according to any one of claims 18 to 21, wherein: The cavity is defined by a rear wall and a front wall, which are connected at their peripheries and are formed by a flexible sheet; the method includes providing a rear wall and a front wall formed by a flexible sheet and connecting them at their peripheries; the method also includes bonding the inner surface of the comfort material sheet to the periphery of one or more of the rear wall and / or the front wall of the ostomy bag; wherein the method includes simultaneously achieving: connecting the front wall and the rear wall of the cavity, and bonding a portion of the first surface of the comfort material sheet to at least one wall of the cavity.

23. The method according to any one of claims 18 to 22, wherein: The sheet of comfort material comprises two or more portions, and the method comprises arranging the portions of the sheet of comfort material and bonding the portions of the sheet of comfort material to the bag.

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

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

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