Ostomi Pouch

Abstract

The ostomy pouch comprises inner and outer walls of a flexible sheet material defining a cavity for containing stoma output, a deployable drain for draining stoma output from the cavity, and at least one sheet of comfort material. The drain moves between an expanded configuration for draining stoma output and a stored configuration for containing the drain. A first sheet of comfort material is attached to the outer wall, and a portion of the first sheet of comfort material forms a flap. The flap folds between a covering position and an access position along a fold line, the fold line being between the deployable drain and a top edge of the ostomy pouch in the stored position.

Description

[Technical field]

[0001] The present invention relates to an ostomy pouch, and more particularly to a drainable ostomy pouch. [Background technology]

[0002] An ostomy pouch can be used to collect and hold stoma output from a stoma formed in the ostomate's body. A stoma is generally a surgical opening in the torso of the ostomate's body, but can also refer to an internal tissue, organ, or portion thereof exposed by the opening. An ostomy pouch generally takes the form of a pair of walls that are sealed together to form a cavity through which stoma output can exit the ostomate through the formed stoma.

[0003] Considering the nature and uses of the ostomy pouch, it is desirable that the pouch can be worn as easily and discreetly as possible by the ostomate. It is also advantageous for the pouch to be worn for extended periods of time to increase the convenience for the ostomate. For this reason, some ostomy pouches may be provided with a drain that allows the ostomate to intermittently drain stoma discharge from the cavity. The drain is generally movable in some manner (e.g., by folding and / or rolling) between a stowed position in which the pouch is closed and a deployed position in which the drain is open and allows the contents of the pouch to be discharged therefrom, for example by opening a drain opening in the pouch.

[0004] It may be desirable for the user that the contents of the Ostomy pouch and / or drain be hidden during normal use (having the ability to identify an emptyable device is an undesirable feature, as the emptying process is considered to be somewhat unpleasant).

[0005] Thus, some known solutions include some type of device for hiding the drain, such as ConvaTec's Esteem®+Convex Invisiclose Drainable Pouch with Lock-it Pocket™ pouch, which provides a device with an additional layer or layers of comfort material placed at the base of the pouch to form a pocket in which the drain can be hidden when folded upwards and the pocket is inverted. However, such pouches require additional manufacturing steps, are cumbersome from an ease of use perspective due to their increased complexity, and may require the ostomate to use both hands to fully contain (and hide) the drain. For example, the Lock-it Pocket™ is closed by placing thumbs on the bottom corners of the Lock-it Pocket™ and turning it inside out like closing a money bag to securely hold the drain. Whilst this certainly improves discretion and reliability, the product still has a flat base and takes its form from an upwardly folded drain and is therefore identifiable as a drainable device (considered an undesirable characteristic as the draining process is considered to be somewhat unpleasant).

[0006] The SALTs Confidence BE drainable pouch offers an alternative in that the base of the opaque comfort layer and the adjacent opaque film layer are welded to the periphery of the two film layers forming the cavity, except for the base, thus forming a small flap behind which the drain can be hidden when it is contained / folded and introduced into the opening formed between the flap and the cavity. However, due to the way in which this flap is formed by being welded with the film layers forming the cavity, there is a risk of damaging the entire pouch. In particular, the inventors have determined that since the fold line around which the flap is folded overlaps the contained drain, the user may apply excessive force to expose the drain, which may result in the adhesion of the covering layer being damaged. This is undesirable, as damage to the pouch may result in the pouch being discarded too soon, and damage is understood as preventing the functioning of the pouch.

[0007] It is an aim of embodiments of the present invention to overcome or at least partially alleviate one or more problems in the prior art. Summary of the Invention

[0008] In accordance with a broad aspect of the present invention, an ostomy pouch is provided that includes a deployable drain and a flap of comfort material configured to fold between a cover position and an access position along a fold line that is located between the deployable drain and a top edge of the ostomy pouch in the stored position (i.e., located above the deployable drain when stored).

[0009] The ostomy pouch may include inner and outer walls of a flexible sheet material. The inner and outer walls may define a cavity for accommodating stoma drainage. The ostomy pouch may have at least one sheet of comfort material. The deployable drain may be movable between an expanded configuration for accommodating stoma drainage from the cavity and a stored configuration for accommodating the deployable drain. A first sheet of comfort material may be attached to the outer wall. At least a portion of the first sheet of comfort material may form a flap. The flap may be configured to fold along a fold line between a covering position where the flap covers the deployable drain when the deployable drain is in the stored configuration and an access position where the deployable drain in the stored configuration is not covered by the flap and is accessible for deployment.

[0010] According to one aspect of the invention, there is provided an ostomy pouch comprising inner and outer walls of a flexible sheet material defining a cavity for accommodating stoma discharge, a deployable drain for accommodating stoma discharge from the cavity, and at least one sheet of comfort material, the deployable drain being movable between an expanded configuration for accommodating stoma discharge from the cavity and a stored configuration for accommodating the deployable drain, a first sheet of comfort material attached to the outer wall, at least a portion of the first sheet of comfort material forming a flap, the flap configured to fold along a fold line between a covering position in which the flap covers the deployable drain when the deployable drain is in the stored configuration and an access position in which the deployable drain is not covered by the flap in the stored configuration and is accessible for deployment, the fold line being between the deployable drain in the stored position and a top edge of the ostomy pouch.

[0011] Advantageously, the location of the fold line between the deployable drain and the top edge of the Ostomy pouch in the retracted position (i.e. such that the fold line does not overlap the deployable drain) means that the entire (retracted) drain is accessible when the flap is folded upwards (unlike the SALTS Confidence BE (RTM) product mentioned above). This allows easy access to the deployable drain and reduces the risk of damage to the adhesion of the comfort material. This may in turn reduce the risk of damage to the entire pouch during draining. Because the risk of damage is reduced, the lifespan of an individual pouch may be increased and fewer pouches are required. This may have the environmental benefit of reducing the amount of environmental waste.

[0012] Any feature presented below may apply to any aspect of the invention, as appropriate.

[0013] The inner and outer walls may define a deployable drain for draining stoma discharge from the cavity. The drain may have an elongated extension of the inner and outer walls. The inner and outer walls together may define an elongated drain channel extending from a drain inlet in the cavity and a drain opening at a distal end of the drain channel through which drain discharge from within the cavity may be discharged from the pouch.

[0014] The inner and outer walls may be sealed (e.g., welded) around their perimeter to define a cavity and / or drain. The seal / weld may comprise a single continuous edge seal. The single continuous edge seal may extend from a first edge (e.g., left edge) of the drain channel to a second edge (e.g., right edge) of the pouch drain channel. The single continuous edge seal may have a weld width, for example, optionally between 2 mm and 6 mm, or between 3 mm and 5 mm, or about 4 mm. The single continuous edge seal may have a constant width around the perimeter of the Ostomy pouch.

[0015] The first sheet of comfort material may be joined to the outer wall around at least a portion of its perimeter. The joining may be by use of welding, adhesive, or equivalent means. The weld attaching the first sheet of comfort material to the outer wall may be contiguous with the welds that define the cavity. A single joining operation may be used to join the inner wall, the outer wall, and the first sheet of comfort material together. For example, a single weld may be used to join the three layers. The first sheet of comfort material may be attached directly to the outer wall around its perimeter.

[0016] The fold line may be defined by a line extending between two points around the perimeter where the attachment between the first sheet of comfort material and the outer wall terminates. The fold line may be defined by a further point of attachment between the first sheet of comfort material and the outer wall. The fold line may be located at a distance of between 20mm and 50mm, or between 30mm and 40mm, for example about 35mm, for example about 34mm, from the lowest edge of the pouch when the drain is in the retracted position.

[0017] The flap may be configured to fold about a fold line such that a distal end of the flap from the fold line lifts away from the pouch toward a top edge of the pouch to move to the access position. The flap may be configured to fold about a fold line such that a distal end of the flap from the fold line moves toward a bottom edge of the pouch to move to the cover position. The bottom edge of the pouch may be defined by an interface between the drain and the cavity. The interface between the drain and the cavity may be defined by a fold line between the drain and the cavity.

[0018] The flap may be shaped such that its distal end from the fold line matches the shape of the periphery of the Ostomy pouch. The flap may be shaped to correspond to one or more contours of the Ostomy pouch. For example, in some embodiments, the pouch may have one or more curved edges and the flap may be similarly curved to correspond to the contours of the curved edges of the pouch. The distal end of the flap may be heated to give the appearance of a weld (to align with the weld line around the periphery of the pouch).

[0019] The first sheet of comfort material may have a first portion and a second portion, and the first portion and the second portion may be joined to the exterior wall such that the first portion partially overlaps the second portion or the second portion partially overlaps the first portion at the overlap region. The first portion and the second portion may be separable from one another at the overlap region to form a window opening for viewing the cavity. The overlap region may be angled to extend horizontally when the pouch is in use. The first portion and the second portion of the first sheet of comfort material may be configured to slide against one another at the overlap region to accommodate expansion of the underlying exterior wall. The first portion and the second portion may be joined to one another at a first end and a second end of the overlap region. The first portion and the second portion may be welded to one another at the first end and the second end of the overlap region, optionally as part of a perimeter weld of the pouch. An outer edge of one or more portions of the first sheet of comfort material may be shaped and sized to correspond to the shape, form, and contour of the exterior wall.

[0020] The Ostomy pouch may include a second sheet of comfort material. The second sheet of comfort material may be attached to the inner wall. The Ostomy pouch may be provided with an opening between the second sheet of comfort material and the inner wall. The opening may be adjacent to the deployable drain. The or each sheet of comfort material may be attached to the respective wall around its periphery. The opening may be provided by a gap in the attachment in the region of the periphery.

[0021] If present, the second sheet of comfort material may have a single portion or multiple portions. The second sheet of comfort material may cover only a portion of the inner wall. However, the second sheet of comfort material preferably covers substantially the entire inner wall. An opening may be provided in the inner comfort layer corresponding to the location of the inlet in the inner wall of the pouch. The inner comfort layer may be shaped and sized to correspond to the shape, form, and contour of the inner wall. The inner comfort layer may be provided with a wafer opening corresponding to the location of the inlet in the inner wall to allow fluid connection between the inlet in the inner wall and the Ostomy wafer.

[0022] A deployable drain may be movable between a stowed position and a deployed position, for example, by rolling or folding the drain about one or more fold lines in the drain. In use, the drain may be moved from the deployed position to the stowed position by folding and / or rolling the drain upwards and away from the ostomate.

[0023] In the retracted position, the drain may extend between 20mm and 50mm, or between 25mm and 40mm, for example about 30mm from the lowest edge of the pouch. In particular, it is a distance from the lowest edge of the pouch that the upper edge of the retracted drain (the top of the drain), defined for example by the penultimate fold, may extend between 20mm and 50mm, or between 25mm and 40mm, for example about 30mm from the lowest edge of the pouch.

[0024] The fold line may be located at least 0.5 mm, at least 1 mm, at least 2 mm, at least 3 mm, or at least 5 mm, at least 7.5 mm, at least 1 cm, or at least 2 cm above the upper edge of the retracted drain. The fold line may be located no more than 5 cm, no more than 3 cm, no more than 2 cm, or no more than 1 cm above the upper edge of the retracted drain, such as preferably between 1 mm and 10 mm, more preferably about 4 mm. Such location of the fold line above the upper edge of the drain in the retracted position allows the fold line to be located between the top of the drain and the top edge of the pouch.

[0025] The ostomy pouch may further comprise a fastener arrangement configured to hold the deployable drain in the retracted position. The fastener arrangement may have a first fastener located on an outer surface (preferably an inner wall) of the deployable drain. The fastener arrangement may have a second fastener located on an outer surface (particularly an outer wall) of the cavity. The second fastener may be provided with a tab. The tab may be fastened to the outer wall of the cavity. When the flap is in the access position, the entire tab may be exposed. The tab may have a fold line configured to fold the tab between the locked and unlocked configurations. The fold line along which the flap is configured to fold may be located between (a) the fold line along which the tab is configured to fold and (b) the top edge of the ostomy pouch. This is beneficial because excessive force is not applied to the fold between the flap and the cavity when the tab is pulled up.

[0026] The fold line along which the tab is configured to fold can be at least 0.1 mm, at least 0.2 mm, at least 0.5 mm, at least 1 mm, or at least 2 mm below the fold line along which the flap is configured to fold. The fold line along which the tab is configured to fold can be no more than 10 mm, no more than 5 mm, or no more than 2 mm below the fold line along which the flap is configured to fold. For example, the fold line along which the tab is configured to fold can be preferably between 2 mm and 7 mm, and more preferably about 5 mm, below the fold line along which the flap is configured to fold.

[0027] In embodiments, the fasteners may be hook-and-loop or hook-and-hook fasteners, for example a first fastener may have a strip of hook fasteners and a second fastener may have a strip of loop fasteners, together forming a hook-and-loop fastener arrangement. Similarly, the second fastener may have a strip of loop fasteners and the first fastener may have a strip of hook fasteners. The first and second fasteners may each have a strip of hook fasteners, forming a dual hook fastener arrangement. Alternative fasteners may include a resealable adhesive.

[0028] The drain may have one or more pursing strips. The pursing strips may comprise a rigid, foldable material. The pursing strips may be associated with the inner and outer walls of the pouch. For example, the pursing strips may be glued or otherwise secured to the inner or outer walls of the pouch. The pursing strips, in part, may aid in the separation of the inner and outer walls of the pouch to define a drain opening in the pouch for stomal discharge to exit the cavity. For example, during use, the pursing strips may bend or arch under application of force by the ostomate / user. The bending or arching of the strips may cause corresponding movement of the inner and / or outer walls of the pouch to define an opening (i.e., a drain opening) in the pouch.

[0029] In an embodiment, the drain may have a pair of pursing strips. The pair of pursing strips may be provided on either side of the drain. For example, the drain may have a first pursing strip on an inner wall and a second pursing strip on an outer wall. The pursing strips may overlap one another. Alternatively, the pursing strips may be offset.

[0030] In embodiments, the drain may be subdivided into two or more segments. The segments may be defined by fold lines along which the drain may fold as it moves between the deployed and stowed positions. For example, the drain segments may be sequentially folded over one another in moving from the deployed to the stowed positions. The drain may have at least two segments, with a first pursing strip located on the inner wall of the pouch and defining at least a portion of the first segment of the drain, and a second pursing strip located on the outer wall of the pouch and defining at least a portion of the second segment of the drain. The drain may be subdivided into three segments, with a second fastener provided on the inner wall of the pouch and defining at least a portion of the third segment of the drain.

[0031] The drain may be provided in a lower portion of the pouch, such as by relying on the bottom of the pouch when the pouch is configured for use in a substantially vertical orientation.

[0032] The flexible sheet material of the inner and outer walls may comprise a single layer or a laminate of several layers. The flexible sheet material of the inner and / or outer walls may comprise polyvinylidene chloride (PVDC) and / or ethylene vinyl acetate (EVA). The thickness of the inner and / or outer walls may be, for example, between 50 and 150 micrometers, or between 75 and 125 micrometers, or between 75 and 100 micrometers.

[0033] The comfort material may be formed from a flexible sheet material. The material of the flexible sheet material may comprise one or more of polyester, nylon, viscose, polyurethane, polyethylene, polypropylene, polyvinylidene chloride (PVDC), and ethylene vinyl acetate (EVA). The comfort layer may comprise a laminate of two or more layers. The comfort layer may comprise at least one fabric layer and at least one film layer. The at least one film layer may be laminated to the at least one fabric layer, optionally over the entire area of ​​the at least one comfort layer. The at least one fabric layer may comprise a woven or non-woven layer. The fabric layer may comprise polyester, nylon, viscose, polyethylene, or polypropylene. The at least one film layer may comprise polyurethane, polyvinylidene chloride (PVDC), or ethylene vinyl acetate (EVA). The thickness of the comfort layer may for example be between 50 and 1000 micrometers, or between 60 and 500 micrometers, or between 75 and 300 micrometers, or between 100 and 200 micrometers.

[0034] The comfort layer (of the first sheet and / or the second sheet) may be a fabric layer, such as a nonwoven or woven layer. The fabric layer may have a hot melt adhesive (e.g., EVA netting). The hot melt adhesive may be disposed on the inner surface of the comfort layer. The hot melt adhesive may penetrate the fabric layer. The netting may have an adhesive mass with voids therein to reduce the amount of material required.

[0035] The hot melt adhesive coating may be applied as a net. The hot melt adhesive net may comprise a mass and a plurality of voids in the mass. The net may be a lattice, mesh, or grid. The net may be a net or dots. The voids may be regularly spaced. The voids may be irregularly spaced. The voids may be regularly shaped. The net may have a regular and consistent distribution of adhesive. The voids may be irregularly shaped. The net may have an irregular and inconsistent distribution of adhesive. Each void may comprise an absence (i.e. a substantial absence) of hot melt adhesive provided in the comfort layer compared to the mass. The voids may comprise at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, or at least 70% of the net.

[0036] This type of netting can therefore be made thinner and / or with less material than a full film, also avoiding the rustling noise associated with films.

[0037] The hot melt adhesive may comprise one or more of polyolefin, ethylene vinyl acetate (EVA), polyurethane, polyvinylidene chloride (PVDC), silicone rubber, fluoropolymer, polycarbonate, styrenic block copolymer, polyester, polyamide, or polycaprolactone. In particular it may comprise EVA or a copolyester. In one embodiment, the hot melt adhesive is a polyolefin. In one embodiment, the hot melt adhesive is ethylene vinyl acetate (EVA). In one embodiment, the hot melt adhesive is a polyurethane. In one embodiment, the hot melt adhesive is polyvinylidene chloride (PVDC). In one embodiment, the hot melt adhesive is a silicone rubber. In one embodiment, the hot melt adhesive is a fluoropolymer. In one embodiment, the hot melt adhesive is a polycarbonate. In one embodiment, the hot melt adhesive is a styrenic block copolymer. In one embodiment, the hot melt adhesive is a polyester. In one embodiment, the hot melt adhesive is a polyamide. In one embodiment, the hot melt adhesive is polycaprolactone. The hot melt adhesive has an areal density of at least 5, 10, 15, 16, or 20 g / m 2 , and / or 50, 40, 35, 30, or 25 g / m 2 Preferably 10 to 50 g / m 2 , 16~35g / m 2 , 20~30g / m 2 , or 23-27g / m 2 , e.g. 25g / m 2 It could be.

[0038] The hot melt adhesive may have a maximum or mean thickness of less than 0.05 mm, less than 0.04 mm, less than 0.03 mm, less than 0.02 mm, or less than 0.01 mm, for example less than 0.005 mm. By providing the hot melt adhesive as a thin layer / web, reduced amounts are required with corresponding advantages in terms of cost, weight of starting materials required, etc.

[0039] The inner surface of the sheet of comfort material may be divided into one or more regions. Hot melt adhesive may be applied to the region or to one or more of the regions. If there is more than one region, specific properties of the netting may be selected for each region. One or more of the regions may not have hot melt adhesive applied to them.

[0040] The first sheet of comfort material may have an outer surface and an inner surface, with at least a portion of the inner surface (preferably including at least the flap) being coated with a web of hot melt adhesive.

[0041] The inner wall of the pouch may have an inlet for receiving stoma discharge into the cavity.

[0042] The pouch may have either an ostomy wafer located within or otherwise associated with the opening in the inner wall, or a releasable fitting located within or otherwise associated with the opening in the inner wall. In embodiments, the releasable fitting may be configured to mate with a body-worn component having an ostomy wafer. If present, the ostomy wafer may extend through an opening in the inner wall and / or inner comfort layer. The ostomy wafer may be provided with an releasable liner that, in use, may be removed by the user prior to securing the pouch to the ostomate.

[0043] In embodiments, the cavity may have one or more portions, such as an upper portion and a lower portion. The cavity may have a waist portion located between the upper portion and the lower portion. The waist portion may have a minimum width that is less than the maximum width of the upper portion and / or the lower portion.

[0044] In embodiments, the cavity may have an upper portion, a lower portion, and a waist portion located between the upper and lower portions.

[0045] The upper and / or lower portions may be generally rounded in shape. For example, the upper portion may have a continuously curved edge that extends from a first edge (e.g., a left edge) of the waist portion to a second edge (e.g., a right edge) of the waist portion. The lower portion may have a continuously curved edge that extends from a first edge (e.g., a left edge) of the waist portion to a second edge (e.g., a right edge) of the waist portion.

[0046] The continuously curved edges of the upper and / or lower portions may be convexly curved. The continuously curved edges of the upper and / or lower portions may not have any inflection points or abrupt changes in contour.

[0047] The juncture between the upper and / or lower portion and the waist portion may be defined by a single inflection point between a left edge of the upper or lower portion and a left edge of the waist portion, and a single inflection point between a right edge of the upper or lower portion and a right edge of the waist portion.

[0048] In accordance with another broad aspect of the invention, a method of draining an Ostomy pouch is provided, the method comprising folding a flap of comfort material upwardly along a fold line located between the deployable drain and a top edge of the Ostomy pouch in a stored configuration to an access position exposing the deployable drain.

[0049] According to one aspect of the invention, there is provided a method of draining an Ostomy pouch, the method comprising folding a flap of comfort material upwardly along a fold line located between the deployable drain in a stored configuration and a top edge of the Ostomy pouch to an access position exposing the deployable drain, deploying the deployable drain to an extended configuration, draining stoma drainage from a cavity, storing the deployable drain in the stored configuration, and folding the flap downwardly along the fold line to a covering position over the deployable drain. The method may further comprise releasing a fastener prior to deploying the deployable drain to the extended position. The method may further comprise securing the deployable drain in the stored configuration with a fastener. The method may further comprise releasing the fastener prior to deploying the deployable drain.

[0050] According to one aspect of the invention, there is provided a method of collecting stoma output using an ostomy pouch according to any aspect described herein. The method comprises attaching the ostomy pouch around the stoma of an ostomate. The ostomy pouch may be attached around the stoma by use of an ostomy wafer of the pouch if the pouch constitutes a one-piece ostomy pouch. Alternatively, the method may comprise attaching an ostomy wafer of a body-worn part of a two-piece ostomy pouch around the stoma, attaching the pouch to the body-worn part. The pouch may be attached to the body-worn part before or after the ostomy wafer is attached around the stoma. If the ostomy pouch has an opening or a drainable pouch, the method may comprise draining the stoma output from the ostomy pouch. The ostomy pouch may be drained according to the method of the preceding aspect of the invention.

[0051] In accordance with another broad aspect of the invention, there is provided a method of forming an ostomy pouch, the method comprising attaching a first sheet of comfort material to an exterior wall of the ostomy pouch and maintaining a flap disposed to cover a deployable drain when in a stored position, the flap being configured to fold along a fold line, the fold line being located between the deployable drain and a top edge of the ostomy pouch in the stored configuration.

[0052] According to one aspect of the invention, there is provided a method of forming an ostomy pouch comprising providing inner and outer walls defining a cavity for accommodating stoma discharge and a deployable drain for draining stoma discharge from the cavity, the deployable drain being movable between an expanded configuration for draining stoma discharge from the cavity and a stored configuration for accommodating the deployable drain, attaching a first sheet of comfort material to the outer wall, and maintaining a flap disposed to cover the deployable drain when in the stored position, the flap configured to fold along a fold line, the fold line being located between the deployable drain and a top edge of the ostomy pouch in the stored configuration.

[0053] In either method, the pouch may be a pouch of any aspect of the invention outlined above, and may include any additional features disclosed above, or combinations thereof. [Brief description of the drawings]

[0054] In order that the invention may be more clearly understood, one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of the body side of an embodiment of an Ostomy pouch according to the present invention. [Diagram 2] FIG. 2 is a perspective view of the garment side of the Ostomy pouch of FIG. 1. [Figure 3a] FIG. 2 is a cross-sectional schematic view of the drain of the Ostomy pouch of FIG. 1 in a deployed position. [Figure 3b] FIG. 2 is a cross-sectional schematic view of the drain of the Ostomy pouch of FIG. 1 in a retracted position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0055] As used here and throughout the specification, the term "stoma output" refers to any gas, liquid, or solid that may be produced by an ostomate and secreted from the stoma, or that is present in the stoma of an ostomate. Stoma output can include gas, fluid, liquid, and / or solid stoma output.

[0056] The term "stoma" refers to an opening in the body. Generally, a stoma is a surgical opening in the torso of the body. In some examples, the term "stoma" also refers to an internal tissue, organ, or portion thereof exposed by the opening. As 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.

[0057] The term "ostomate" refers to a patient who may use the ostomy pouch described herein. Although an ostomate typically refers to a patient with a surgical opening, as used herein, "ostomate" may refer to a patient with a stoma, whether or not the stoma was created by surgery or other means.

[0058] The term "user" may refer to the ostomate or another person assisting the ostomate, for example emptying stoma drainage from the cavity.

[0059] The Ostomy pouches disclosed herein may be used to manage stomas created by, for example, esophagostomy, gastrostomy, cholecystostomy, choledochostoma, cecostomy, colostomy, duodenostomy, ileostomy, jejunostomy, appendicostomy, tracheostomy, urinary diversion, nephrostomy, ureterostomy, or cystostomy. The Ostomy pouches disclosed herein may be used with additional devices, including, but not limited to, shunts, catheters, plugs, or fecal management systems.

[0060] As used herein, the location and orientation of features may be described with reference to the ostomy pouch being "in use", "oriented to be in use", or the like. Such terms refer to the intended orientation of the ostomy pouch when it is attached or otherwise secured to the ostomate's body, for example in the ostomate's standing position, regardless of whether the ostomy pouch is currently in such use or the ostomate's actual location. The terms "upper" and "lower" and related terms refer to the relative locations at which a portion or portions of the ostomy pouch are oriented when it may be in use. For example, a portion of the ostomy pouch may be referred to as an "upper" portion of the ostomy pouch and may refer to the top edge of the pouch. In such an embodiment, the portion / edge is intended to be the topmost portion (vertically) of the ostomy pouch when attached to the body of a standing ostomate. However, a person skilled in the art will understand that this portion may not always be the uppermost portion prior to attachment to the ostomate, and furthermore, that this portion may not always be the uppermost portion when attached if the ostomate is in a non-upright position, such as a recumbent position.

[0061] The terms "left side" and "right side" and related terms may refer to the ostomy pouch when viewed from the rear (e.g., as shown in FIG. 1). Thus, as an illustrative embodiment, the "left side" edge of the ostomy appliance faces the left hand side of the ostomate in the situation where the ostomy pouch is attached to the front torso of the ostomate.

[0062] The terms "concave" and "convex" and related terms refer to the shape of features of the ostomy pouch when viewed from the outside of the ostomy pouch. Thus, as an illustrative example, a circular ostomy wafer would be considered to have a convex shaped outer periphery.

[0063] The terms "inside" and "outside" refer to the relative location of a part or portions of the ostomate's body when the ostomate's pouch is attached (e.g., glued or otherwise) to the ostomate's body. "Inside" refers to a position relatively closer to the ostomate's body than a comparable position that is "outside." "Outside" refers to a position relatively farther from the ostomate's body than a comparable position that is "inside." In the art, inside is synonymous with "body side," while outside is synonymous with "garment side."

[0064] The ostomy pouch is generally attached to the ostomate's body by an ostomy wafer that includes an adhesive layer. The ostomy wafer generally has an opening for the stoma, sometimes called a starter hole, that can 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, a release liner covers the body-facing side of the ostomy wafer and is removed by the user before application to the skin. In this specification, the term "ostomy wafer" may be used interchangeably with the terms "adapter", "wafer", "base plate", or "layered adhesive wafer". The "ostomy wafer", "adapter", "wafer", "base plate", or "layered adhesive wafer" may form a skin barrier between the ostomate and the pouch. In this specification, the term "ostomy wafer" includes ostomy wafers for "two-piece appliance" and "one-piece appliance".

[0065] A "two-piece pouch" refers to an ostomy pouch in which the ostomy wafer forms part of another body-worn component that is attached to the pouch by a releasable connection. A 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 may remain in place on the ostomate's body. In contrast, a "one-piece pouch" refers to an ostomy pouch in which the ostomy wafer is permanently attached to the appliance to the extent that it cannot be easily separated without risk of damaging the appliance. A one-piece pouch is intended to be used as an integral unit.

[0066] An ostomy pouch may generally be configured as a "closed" pouch or an "open" pouch. As used herein, a "closed pouch" refers to an ostomy pouch in which stoma discharge is not intended to be discharged from the cavity. Thus, a closed pouch may generally be configured as a single-use, disposable and non-reusable pouch. As used herein, an "open pouch" refers to an ostomy pouch in which stoma discharge is discharged from the cavity and the pouch can be reused. Thus, an open pouch may be configured as a reusable pouch such that it can be reused and emptied multiple times while attached to the body, but this is not required. In an open pouch, stoma discharge may be discharged intermittently, instigated by the ostomate's movements, or intermittently or continuously, by the cavity being fluidly connected to a drain, e.g., a night drain line.

[0067] The use of a closed or open pouch may be in part a matter of user preference, but similarly either a closed or open pouch may be more suitable depending on the particular ostomate's needs and depending on the location of the ostomate's stoma. For example, the stoma drainage for a stoma created by an ileostomy may tend to be loose and easy to drain, resulting in an open pouch being suitable. The stoma drainage for a stoma created by a colostomy tends to be more solid and may not be easily drained by the user. In such cases, a closed pouch may be more suitable.

[0068] Conditional words such as "can," "could," "might," or "may," unless specifically stated otherwise or understood otherwise within the context in which they are used, are generally intended to convey that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional words are generally not intended to entail that features, elements, and / or steps are somehow required in one or more embodiments, or that one or more embodiments necessarily include logic that, with or without user input or action, determines whether those features, elements, and / or steps are included or performed in any particular embodiment.

[0069] 1-3 show an exemplary ostomy pouch 10 having an inner wall 19 and an outer wall 21 sealed around at least a portion of its periphery 11 to define a cavity 12 for accommodating stoma output, and a deployable drain 13. The pouch 10 is thus "open" and has a single provided seal 14 that is a continuous seal around the periphery 11 of the pouch 10 except for the drain opening 15, which will be described in detail below. In this embodiment, the cavity includes a first upper portion 16 and a second lower portion 17 that are generally rounded in shape with convex curved edges. The upper and lower portions 16 and 17 are separated by a waist portion 18 that is narrower than the upper and lower portions 16 and 17. The waist portion 18 has concave curved edges. The deployable drain 13 extends from the lower portion 17 of the pouch.

[0070] Those skilled in the art will readily appreciate that the shape of the Ostomy pouch is not limited to that described above, and in addition, the techniques disclosed herein may be similarly applied to other pouch shapes, such as pouches without a waist portion or pouches having multiple waist portions.

[0071] The inner wall 19 and the outer wall 21 in this embodiment are formed from a flexible plastic sheet material. The pouch 10 also includes a first sheet of comfort material forming an outer comfort layer 31, which in this embodiment also includes a second sheet of comfort material forming an inner comfort layer 32. The inner comfort layer 32 overlies the inner wall 19, and the outer comfort layer 31 overlies the outer wall 21. In this embodiment, the comfort layers 31, 32 are formed from a woven material and define the outer surfaces of the pouch 10. The surfaces of the inner and outer comfort layers 31, 32 facing the inner and outer walls 19 and 21, respectively, are coated with a net of hot melt adhesive (EVA in this example) to allow the comfort layers to be fused to the pouch without the need for an intervening layer. However, it will be appreciated that the comfort layers may be formed from a variety of other materials, provided as multiple layers, etc.

[0072] In this embodiment, the outer comfort layer is provided in two parts, a first part 31a covering the lower part 17 and the waist part 18 and partially covering the upper part 16, and a second part 31b partially covering the upper part 16. The first and second parts partially overlap in the overlapping area. The second part 31b is joined to the outer wall 21 around its periphery 11. The first part 31a is joined to the outer wall 21 along a part of its periphery, the first part 31a being joined along a right periphery 35a and a left periphery 35b, which joints terminate in lower welded ends 35a', 35b'. The lower edge of the first part 31a is not joined to the outer wall, but instead forms a flap 33. The flap 33 folds along a flap fold line 34 that extends between lower welded edges 35a', 35b' of the left and right perimeter joints of the first portion 31a. The flap 33 is shaped such that when in a covering position over a deployable drain (described in more detail below) in the stowed position, a distal edge 36 from the flap fold line 34 conforms to the shape of the pouch when the drain is in the stowed position.

[0073] The first and second parts 31a, 31b of the outer comfort layer are separable from one another at the overlap region 22 in order to form a window opening for viewing the cavity, in use. In the embodiment shown, the second part 31b overlaps the first part 31a at the overlap region, but a person skilled in the art will recognize that such overlap can be formed in the opposite way, i.e. the first part 31a overlaps the second part 31b at the overlap region 22, and of course in other embodiments the outer comfort layer may be formed in one part without overlap.

[0074] The inner wall 19 has an opening 50 therein defining a stoma entrance 51 of the pouch 10 for receiving stoma output into the cavity. The stoma entrance 51 is located in the upper portion 16 of the pouch. In this embodiment, the inner comfort layer 32 is provided with an opening 35 located concentrically with the stoma entrance, allowing an Ostomy wafer 52 to be applied to the stoma during use. In this embodiment, the Ostomy wafer 53 is permanently attached to the pouch, i.e. the pouch is a one-piece pouch, although it could of course be separable (i.e. a two-piece pouch).

[0075] In this embodiment, the weld between the inner wall and the inner comfort layer does not extend around its entire periphery, leaving a portion 76 adjacent the drain 13 unwelded such that a gap is formed between the inner wall and the inner comfort layer.

[0076] As mentioned above, the inner wall 19 and the outer wall 21 further define a deployable drain 13. The drain 13 is integral with the inner and outer walls and in this embodiment is elongated, extending from the lower edge of the lower portion 17, with welds around the periphery 11 extending along each edge of the drain to a drain opening 15 where the pouch remains unsealed, i.e., an area of ​​the periphery 11 where the inner and outer walls are not joined to one another. In use, the drain opening 15 may be used to remove stoma discharge from the cavity.

[0077] In this embodiment, the drain 13 is divided along its length into three equal portions 66, 67, 68 by first and second fold lines 63, 64 extending laterally across the drain 13, and a third fold line 65 extends laterally across the drain at the drain / cavity interface defining the lowest edge of the pouch (when the drain is retracted). This embodiment includes a first pursing strip 61 disposed on a portion of the inner wall 19 defining a portion 66 adjacent the drain opening 15. A second pursing strip 62 is disposed on a portion of the outer wall 21 defining an intermediate portion 67 of the drain 13 in this embodiment. A first fastening means 69 is disposed on a portion of the inner wall defining a portion 68 adjacent the cavity, and in this illustrated embodiment the fastening means is a strip of self-gripping fastening hook tape. Those skilled in the art will appreciate that other fastening means are also suitable, that the pursing strips are a desirable but optional feature, and that other configurations are within the scope of the present invention.

[0078] The second fastener 70 is disposed on the lower portion of the exterior wall 21 of this exemplary pouch. The second fastener 70 is disposed centrally and below the fold line extending between the lower welded ends 35a', 35b'. The second fastener 70 in this particular embodiment is formed of a foldable foam tab that folds about a tab fold line 75 that defines two portions of the second fastener 70: an adhesive portion 71 and a fixed portion 73. One side of the adhesive portion 71 is coated with an adhesive 72 that bonds the foam tab to the outer surface of the exterior wall 21. The fixed portion 73 is provided with a second fastening means 74 (in this illustrated embodiment, a strip of self-gripping fastening hook tape) disposed on the opposite surface of the tab to the adhesive 72 on the adhesive portion. In this embodiment, the foldable foam tab is positioned such that its fold line 75 is parallel to, but lower than, the fold line 64 of the flap 33 (i.e., the fold line of the foldable foam tab is positioned closer to the lower edge of the pouch).

[0079] During use, the drain 13 is movable between an extended configuration (as shown in FIG. 3a) and a stored configuration (as shown in FIG. 3b). In this embodiment, the drain 13 moves from the extended configuration to the stored configuration in the following manner: First, a portion 66 of the drain proximate the drain opening 15 is folded away from the body about a first fold line 63 such that the portion of the outer wall 21 forming the intermediate portion 67 of the drain and the portion 66 proximate the drain opening 15 are in contact. Next, the drain is folded away from the body about a second fold line 64 such that the inner wall 19 forming the portion 66 proximate the drain opening 15 and the outer wall 21 forming the portion 68 proximate the cavity are in contact. A third fold is made about the third fold line, again folding the drain 13 away from the body such that the portion 62 of the inner wall 19 forming the intermediate portion 67 is in contact with the outer wall 21 of the cavity. In the stored configuration, the top of the retracted drain as formed by the second fold line 64 is disposed below a line extending between the lower welded ends 35a', 35b'. One skilled in the art will recognize that the drain may have more or fewer portions that may be applied to accommodate more or less number of folds. Additionally, as an alternative to folding the drain, the drain may be stored in an alternative manner, such as by being rolled.

[0080] When the drain 13 is in the stored configuration, the repeated folding about the three fold lines 63, 64, 65 effectively seals the drain 13 so that stoma discharge does not leak from the cavity. The drain may be held in the stored configuration by folding the second fastener 70 about fold line 72 so that the first and second fastening means 69, 74 contact. The flap 33 may then be folded downwardly about the flap fold line 34 to cover the drain 13 in the stored configuration.

[0081] Conversely, to allow drainage of the pouch 10, the drain 13 may be moved from the stored configuration to the deployed configuration. First, the flap is folded back about the flap fold line 34 to fully expose the retracted drain 13 and the securing tab 70 (i.e., the flap fold line does not overlap the retracted drain or the securing tab). The securing tab 70 may then be removed from the drain and the folding action is reversed to move the drain from the stored configuration to the extended configuration (i.e., unfolding about the third fold line 65, then the second fold line 64, and finally the first fold line 63), such that the drain 12 is no longer sealed and stoma drainage may be allowed to exit the cavity via the drain opening 15.

[0082] In this specification, all numbers indicating quantities of materials, dimensions of devices, and the like, should be understood as being modified by the language "about," unless in the examples or otherwise expressly indicated.

[0083] 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 pouch, comprising: an inner wall and an outer wall of a flexible sheet material defining a cavity for receiving stoma effluent; a deployable drain for discharging the stoma effluent from the cavity; at least one sheet of comfort material; wherein the deployable drain is movable between an expanded configuration for discharging the stoma effluent from the cavity and a stored configuration for storage of the deployable drain; a first sheet of comfort material is attached to the outer wall, and at least a portion of the first sheet of comfort material forms a flap, the flap being configured to fold along a fold line between a cover position where the flap covers the deployable drain when the deployable drain is in the stored configuration and an access position where the deployable drain in the stored configuration is not covered by the flap and is accessible for deployment; the fold line is located between the deployable drain in the stored configuration and the uppermost edge of the ostomy pouch, the ostomy pouch.

2. The first sheet of comfort material is attached to the outer wall at least around at least a portion of its outer periphery, The ostomy pouch according to claim 1.

3. The fold line is defined by a line extending between two points around the outer periphery where the attachment between the first sheet of comfort material and the outer wall terminates, The ostomy pouch according to claim 2.

4. The flap is shaped such that the distal edge from the fold line conforms to the shape of the outer periphery of the ostomy pouch, The ostomy pouch according to claim 1.

5. The comfort material forming the flap is coated with a hot melt adhesive, The ostomy pouch according to claim 1.

6. further comprising a fixture arrangement configured to hold the deployable drain in the stored configuration, the fixture arrangement having a first fixture located on the outer surface of the deployable drain and a second fixture located on the outer surface of the cavity, The ostomy pouch according to claim 1.

7. The second fixture has a tab fixed to the outer wall of the cavity, The ostomy pouch according to claim 6.

8. The tab has a tab fold line configured such that the tab folds between a fixed configuration and a non-fixed configuration, The ostomy pouch according to claim 7.

9. The foldable portion of the tab is exposed when the flap is in the access position. The stoma port according to claim 8.

10. The tab fold line is disposed between the fold line of the flap and the lower edge of the stoma port. The stoma port according to claim 9.

11. The fold line of the flap is disposed between the tab fold line and the uppermost edge of the stoma port. The stoma port according to claim 8.

12. The tab fold line is disposed at least 0.5 mm below the fold line of the flap. The stoma port according to claim 8.

13. The tab fold line is disposed at least 1 mm below the fold line of the flap. The stoma port according to claim 8.

14. The tab fold line is disposed 10 mm or less below the fold line of the flap. The stoma port according to claim 8.

15. The tab fold line is disposed 5 mm or less below the fold line of the flap. The stoma port according to claim 8.

16. The fold line of the flap is disposed at a distance between 20 mm and 50 mm from the lower edge of the stoma port when the drain is in the stored configuration. The stoma port according to claim 1.

17. The fold line of the flap is disposed at a distance between 30 mm and 40 mm from the lower edge of the stoma port when the drain is in the stored configuration. The stoma port according to claim 16.

18. The fold line of the flap is disposed at a distance of at least 1 mm above the upper edge of the stored drain. The stoma port according to claim 1.

19. The flap is configured to fold around the fold line such that the end of the flap distal from the fold line is lifted away from the stoma port and towards the uppermost edge of the stoma port to move to the access position. The stoma port according to claim 1.

20. The stoma port further has a window opening for viewing the cavity. The stoma port according to claim 1.

21. The window opening is disposed on the outer wall, and the first sheet of the comfort material has a first portion and a second portion, wherein the first portion partially overlaps the second portion, or the second portion overlaps the first portion in an overlapping region forming the window opening. The stoma port according to claim 20.

22. A method of forming a stoma port, comprising: providing an inner wall and an outer wall defining a cavity for accommodating stoma discharge, and a deployable drain for discharging the stoma discharge from the cavity, wherein the deployable drain is movable between an expanded configuration for discharging the stoma discharge from the cavity and a retracted configuration for accommodating the deployable drain; attaching a first sheet of a woven comfort material to the outer wall and leaving a flap disposed to cover the deployable drain when in the retracted configuration; wherein the flap is configured to fold along a fold line; the fold line being located between the deployable drain in the retracted configuration and the uppermost edge of the stoma port.

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