Ostomy pouch
The ostomy pouch design addresses the visibility and usability issues of transparent drains by using a partially opaque inner and transparent outer wall configuration, enabling discreet and comfortable drainage monitoring.
Patent Information
- Application Number
- JP2022573769
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-06-02
- Filing Date
- 2021-06-01
- Publication Date
- 2025-12-25
- Estimated Expiration
- 2041-06-01
AI Technical Summary
Existing ostomy pouches with transparent drainage sections fail to adequately conceal waste when the drain is retracted, requiring complex mechanisms and additional manufacturing steps, and are uncomfortable to use.
An ostomy pouch design featuring a deployable drain with a fastener arrangement that includes a partially opaque inner wall and partially transparent outer wall, allowing the drain to be stowed over a comfort layer, ensuring discretion and ease of use.
The design enables extended pouch wear time, reduces environmental waste, and allows users to monitor drainage without the drain being visibly obvious, enhancing user comfort and convenience.
Smart Images

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Abstract
Description
[Technical Field]
[0001] FIELD OF THE INVENTION The present invention relates to ostomy pouches, and more particularly to drainable ostomy pouches. [Background technology]
[0002] An ostomy pouch can be used to collect and retain stoma output from a stoma created in the ostomate's body. Generally, a stoma is a surgical opening in the torso of the ostomate's body, but it can also refer to the internal tissue, organ, or part thereof exposed by the opening. An ostomy pouch usually has a pair of sealed walls to form a cavity into which stoma output is discharged from the ostomate through the created stoma.
[0003] Given the nature and uses of ostomy pouches, it is desirable that they be as easy and unobtrusive as possible for the ostomate to wear. It is also advantageous for the pouch to be able to be worn for extended periods of time, for increased convenience to the ostomate. Therefore, ostomy pouches may be provided with a drain to allow intermittent drainage of stoma output from the cavity. The drain is usually movable in some way (e.g., by folding or rolling) between a stowed position in which the pouch is closed and an expanded position in which the drain is open to allow the contents of the pouch to be drained therefrom—for example, by opening a drain opening in the pouch.
[0004] It may be desirable for the user to have the contents of the ostomy pouch hidden during normal use. Therefore, pouches are typically made from opaque materials and / or have an opaque cover or "comfort" layer over the pouch walls. However, the ostomate / user may also desire to be able to see the contents of the pouch during drainage, or at least the stoma output passing through the pouch drain, in order to have more control over the process.
[0005] Thus, some known solutions include substantially opaque ostomy pouches with a transparent drainage section that allows the user to see the stoma waste as it is drained. However, many current solutions suffer from the problem that the transparent portion of the pouch (e.g., the drain) still allows some of the waste within the pouch to be seen, even when the drain is retracted and folded. Furthermore, solutions such as those used in ConvaTec's Esteem®+ Convex Invisiclose Drainable Pouch with Lock-it Pocket® pouches use an additional or multiple layers of comfort material on the bottom of the pouch to form a pocket that folds over and conceals the drain when the pouch is inverted. While their primary purpose is to provide a means to secure the drain in the retracted position, such arrangements can also be used to conceal the visible transparent portion of the pouch that contains the drain. However, such pouches require additional manufacturing steps, are more complex from a usability perspective, and may require the ostomate to use both hands to fully retract (and conceal) the drain. For example, the Lock-it Pocket® is closed by placing one's thumbs into the bottom corners of the Lock-it Pocket® and turning it inside out like closing a drawstring bag, holding the drain tight. While this certainly improves discretion and safety, the product still has a flat bottom and takes its shape from that of the folded drain, making it recognizable as a drainable device (this is considered an undesirable characteristic, as the draining process is considered to be somewhat uncomfortable).
[0006] It is an object of one or more embodiments of the present invention to overcome or at least partially alleviate one or more problems associated with the prior art. Summary of the Invention
[0007] According to one aspect of the present invention, there is provided an ostomy pouch comprising inner and outer walls defining a cavity for receiving stoma waste and a drain for discharging the stoma waste from the cavity, a comfort layer at least partially disposed on an outer surface of the inner and / or outer walls of the cavity, and a fastener arrangement configured to hold the drain in a stowed position, the fastener arrangement including a first fastener located on the comfort material and a second fastener disposed on the inner or outer wall of the ostomy pouch, wherein at least a portion of the inner wall defining the drain is substantially opaque and at least a portion of the outer wall defining the drain is at least partially transparent.
[0008] According to one aspect of the present invention, there is provided an ostomy pouch comprising: a cavity for containing stomal waste defined by inner and outer walls of a flexible sheet material sealed around its periphery; a deployable drain for draining stomal waste from the cavity; a substantially opaque comfort layer at least partially disposed on an outer surface of the inner and / or outer walls of the flexible sheet material; and a fastening arrangement configured to hold the deployable drain in a stowed position, the fastening arrangement including a first fastener disposed on the outer surface of the comfort material and a second fastener disposed on the inner or outer wall of the ostomy pouch, wherein the deployable drain is movable between a deployed position for draining stomal waste from the cavity and a stowed position for stowed the deployable drain, wherein in the stowed position at least a portion of the drain overlies a portion of the comfort layer, and at least a portion of the inner wall defining the deployable drain is substantially opaque and at least a portion of the outer wall defining the deployable drain is at least partially transparent.
[0009] Advantageously, the ostomy pouch of the present invention may enable ostomates to extend the duration of pouch use by providing a reliable and hygienic means for draining stoma waste into the pouch cavity. Because ostomates may be inclined to use each ostomate appliance of the present disclosure for a longer period of time, the total number of ostomate appliances used by an ostomate over a given period of time may be reduced. This may also have environmental benefits, such as reducing the generation of environmental waste. By providing a drain that is at least partially transparent on one side, particularly the outer wall side, the ostomate or user can view the contents of the pouch while draining. By providing a drain that is substantially opaque on one side, particularly the inner wall side, and locating a fastener in a comfort material overlying one or both walls of the pouch, the drain can be moved to a storage position above the comfort material, allowing the contents of the pouch to be stored while remaining hidden.
[0010] Any of the features described below may be applied to any aspect of the invention, as appropriate.
[0011] The drain may have an elongated extension of the inner and outer walls that together may define an elongated drain channel extending from a drain inlet in the cavity and an outlet at a distal end of the drain channel through which stomal waste from within the cavity may exit the pouch.
[0012] The inner and outer walls may be sealed (e.g., welded) around their perimeter to define the cavity and / or drain. The seal / weld may have 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 drain channel of the pouch. The single continuous edge seal may have a weld, which may optionally have a width, for example, 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.
[0013] The deployable drain may also be movable between the stowed position and the deployed position, for example, by rolling or folding the drain about one or more fold lines on the drain. In use, the drain can be moved from the deployed position to the stowed position by folding and / or rolling the drain in an upward direction, away from the ostomate.
[0014] In embodiments, the first fastener may comprise a strip-shaped hook fastener and the second fastener may comprise a strip-shaped loop fastener, together forming a hook-and-loop fastener configuration. Similarly, the second fastener may comprise a strip-shaped loop fastener and the first fastener may comprise a strip-shaped hook fastener. The first and second fasteners may each comprise a strip-shaped hook fastener to form a dual hook fastener configuration.
[0015] The second fastener may be located on the inner wall of the pouch. In embodiments, the second fastener is located on a portion of the inner wall of the pouch that at least partially defines the drain. Advantageously, when the drain is retracted (e.g., by rolling or folding the drain upward and away from the ostomate during use), the fastener located on the inner wall of the pouch (i.e., the second fastener) can be adjacent to the fastener located on the outer surface of the pouch (i.e., the comfort layer) (i.e., the first fastener).
[0016] The first fastener may comprise a flap, which itself may be secured (e.g., adhesively using adhesive tape, welded, or otherwise) to the comfort layer of the pouch. For example, in some embodiments, the first fastener may comprise a hook-and-loop fastener strip provided on a flap secured to the outer surface of the comfort layer. The flap may comprise a flexible material, for example, a flexible plastic material.
[0017] The comfort material may be a nonwoven or woven layer. In the case of a woven layer, the woven layer may include a hot melt adhesive (e.g., a web of EVA) in the area of the flap to aid in bonding the flap and comfort material, for example, during a welding operation. The hot melt adhesive may be disposed on the inner surface of the woven layer, and the flap may be attached to the outer layer. The hot melt adhesive may penetrate the woven layer during welding to improve the bond between the flap and the woven layer. The entire inner surface of the comfort material to which the flap is attached may be coated with a web of hot melt adhesive. The web may have adhesive masses with voids therein to reduce the amount of material required.
[0018] The flap may be provided on a comfort layer that, in use, overlaps the outer wall of the pouch away from the ostomate.
[0019] The flap may be shaped to correspond to one or more contours of the ostomy pouch. For example, in some embodiments, the pouch has 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 flap may be wider than the drain. The flap may extend across substantially the entire width of the pouch. This may allow the folded drain to be less noticeable than if the flap were attached to the drain itself. The flap may extend to the edge of the pouch or to the seal around the perimeter of the pouch. In some embodiments, if the flap extends to the seal, it may be glued or welded to the pouch. In some embodiments, if the flap extends to the edge of the pouch, it may be adhered to the pouch using, for example, adhesive tape. Advantageously, the flap can extend the greatest distance across the width of the pouch without interfering with the sealed perimeter of the pouch. By providing a flap rather than an inverted pocket to cover the drain, the fact that the product is drainable may be less obvious, as the base shape can be freely designed without being constrained by the shape of the folded drain. Furthermore, closing a flap may be easier than closing a pocket, for example, with one hand or for users with reduced manual dexterity.
[0020] The drain may have one or more pursing strips. The pursing strips may be constructed of a rigid, flexible material. The pursing strips may be associated with the inner or outer wall of the pouch. For example, the pursing strip may be secured to the inner or outer wall of the pouch with an adhesive or the like. The pursing strip may, in part, separate the inner and outer walls of the pouch and help define a drain opening within the pouch for stoma waste to exit the cavity. For example, in use, the pursing strip may bend or arch depending on the force applied by the ostomate / user. The bending or arching of the strip may cause a corresponding movement of the inner and / or outer wall of the pouch, thereby defining an opening (i.e., a drain opening) within the pouch.
[0021] In embodiments, the drain may include a pair of pursing strips. The pair of pursing strips may be located on opposite sides 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 each other. Alternatively, the pursing strips may be offset.
[0022] The parsing strip may be substantially rectangular in shape and may have one or more curved corners. In some embodiments, the parsing strip may include one or more cutouts or notches that define an interaction area for the user—i.e., an area where the user can apply force to the strip to cause it to bend / arch. For example, the parsing strip may include a pair of opposing cutout areas / notches. In embodiments consisting of a pair of parsing strips, each of the parsing strips may have one or more cutout areas or notches, which may optionally be aligned (where the strips overlap) or positioned adjacent (where the strips are offset from one another) to corresponding cutout areas or notches in the other parsing strip. Advantageously, the cutout areas / notches of a pair of parsing strips can together define an interaction area for the user.
[0023] In embodiments, the drain may be divided 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 retracted positions. For example, the drain segments may sequentially fold over one another as it moves from the deployed to the retracted position. The drain may have at least two segments, with a first pursing strip disposed 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 disposed on the outer wall of the pouch and defining at least a portion of the second segment of the drain. The drain may be divided into three segments, with a second fastener disposed on the inner wall of the pouch and defining at least a portion of the third segment of the drain.
[0024] At least a portion of the deployable drain is visible in the stowed position. For example, in the stowed position, a portion of the deployable drain is covered by a flap, but one or more portions are uncovered, thereby remaining visible even during use. The portion or portions visible in the stowed position can include a region or regions of the drain at or proximal to one or more edges, and optionally one or more lateral edges, of the drain. The portion or portions visible in the stowed position may preferably comprise a portion of the opaque interior wall of the pouch defining the drain.
[0025] The drain may be located in the lower section of the pouch, for example, if the pouch is configured for use in a substantially vertical orientation.
[0026] The inner wall of the pouch may include an inlet for receiving stoma waste into the cavity. In a currently preferred embodiment, the inlet is provided in a portion of the inner wall that defines at least a portion of the upper section of the pouch.
[0027] The flexible sheet material of the inner and outer walls may be a single layer or a laminate of multiple layers. The flexible sheet material of the inner and / or outer walls may be made of polyvinylidene chloride (PVDC) and / or ethylene vinyl acetate (EVA). The inner and / or outer walls may have a thickness of, for example, 50 to 150 μm, or 75 to 125 μm, or 75 to 100 μm.
[0028] The comfort layer may be formed from a flexible sheet material. The flexible sheet material may include one or more of polyester, nylon, viscose, polyurethane, polyethylene, polypropylene, polyvinylidene chloride (PVDC), and ethylene vinyl acetate (EVA). The comfort layer may have a laminate of two or more layers. The comfort layer may have 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 woven fabric layer, optionally across the entire area of the at least one comfort layer. The at least one fabric layer may include a woven or nonwoven fabric layer. The fabric layer may include polyester, nylon, viscose, polyethylene, or polypropylene. The at least one film layer may include polyurethane, polyvinylidene chloride (PVDC), or ethylene vinyl acetate (EVA). The comfort layer may for example have a thickness of between 50 and 1000 μm, or between 60 and 500 μm, or between 75 and 300 μm, or between 100 and 200 μm.
[0029] The pouch may include an inner comfort layer and / or an outer comfort layer. The inner comfort layer may cover at least a portion of the inner wall of the pouch. The outer comfort layer may cover at least a portion of the outer wall of the pouch. The comfort layer (e.g., the inner and / or outer comfort layer) may not overlap the inner or outer wall of the pouch in the portion of the inner and / or outer wall that defines the drain.
[0030] If present, the outer comfort layer may include a first portion and a second portion, and may be bonded to the outer wall such that the first portion overlaps the second portion at an overlap region. The first and second portions may be separable from each other at the overlap region to form a window opening for viewing the cavity. The overlap region may be angled to extend laterally when the pouch is in use. The first and second portions of the outer comfort layer may be configured to slide over each other at the overlap region to accommodate expansion of the underlying outer wall. The first and second portions may be joined to each other at first and second ends of the overlap region. The first and second portions may be welded to each other at the first and second ends of the overlap region, optionally as part of a perimeter weld of the pouch. The outer edges of one or more components of the outer comfort layer are shaped and sized to correspond to the shape, configuration, and contour of the outer wall.
[0031] If present, the inner comfort layer may be comprised of a single piece or multiple pieces. The inner comfort layer may cover only a portion of the inner wall. Preferably, however, the inner comfort layer covers substantially the entire inner wall. The inner comfort layer may have an opening 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 have a wafer opening corresponding to the location of the inlet in the inner wall to allow fluid communication between the inlet in the inner wall and the Ostomy wafer.
[0032] The inner wall and inner comfort layer may be joined at their peripheries, and the outer wall and outer comfort layer may be joined at their peripheries. Joining may be by welding, adhesive, or equivalent means. A single joining operation may join the inner comfort layer, inner wall, outer wall, and outer comfort layer. For example, a single weld may be used to join all four layers.
[0033] The cavity may be a single volume or may be divided into two or more chambers. For example, the two or more chambers may be separated by, for example, one or more dividers, wall members, or filter elements. In some embodiments, the pouch includes a partition between the inner and outer walls that defines the cavity into first and second chambers. The partition may have a filtration element. The filtration element may be fluid-permeable and operable to filter fluid stoma waste from solid stoma waste.
[0034] The filtering element may include an array of openings that allow fluid stoma waste to pass therethrough. The openings may have diameters of, for example, 0.02 mm to 0.10 mm, or 0.03 mm to 0.08 mm, or 0.04 mm to 0.06 mm, or 0.06 mm to 0.08 mm, or 0.10 mm to 0.40 mm. The spacing between adjacent openings in the array may be, for example, 0.80 mm to 2.20 mm, or 1.00 mm to 2.00 mm, or 1.25 mm to 1.75 mm. The openings may extend over at least 50%, or at least 75%, or at least 80%, or at least 90% of the surface of the filtering element. The filtering element may span at least the lower half or lower quarter of the cavity and / or at least the upper half or upper quarter of the cavity.
[0035] In use, the first chamber of the cavity is arranged to receive both fluid and solid stoma waste from the ostomate via an inlet in the inner wall. The dividing wall is arranged to allow liquid stoma waste to pass to the second chamber while retaining solid stoma waste in the first chamber. In embodiments where the pouch comprises a filter arrangement, the filter arrangement can further be used to separate gas stoma waste from fluid stoma waste, allowing the gas stoma waste to be removed from the cavity.
[0036] The pouch may have either an ostomy wafer positioned within or otherwise associated with the opening in the inner wall, or a releasable coupling positioned within or otherwise associated with the opening in the inner wall. In embodiments, the releasable coupling may be configured to couple with a body fitting component including 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 include a releasable liner that the user can remove prior to securing the pouch to the ostomate during use.
[0037] The pouch may include a filter arrangement. The filter arrangement may include a vent for venting gas stoma waste from the cavity. The filter arrangement may have an odor filter. The odor filter may comprise, for example, a charcoal or activated carbon filter. The odor filter may be substantially circular or disc-shaped. The major surface of the circular / disc-shaped filter may be open to allow gas stoma waste to enter the filter. The odor filter may comprise, for example, a strip filter open at both ends.
[0038] The filter arrangement, or a component thereof, such as a vent, may be provided within or associated with the outer wall of the ostomy pouch. For example, in certain embodiments, the filter arrangement may comprise an odor filter disposed on the exterior surface of the pouch's outer wall. In such embodiments, the vent may comprise an opening in the outer wall, e.g., a substantially circular opening disposed adjacent to the odor filter and providing a vent through which, in use, gas stoma waste may exit the interior of the pouch and enter the odor filter. Advantageously, mounting the odor filter inside the pouch minimizes exposure of the filter to stoma waste, particularly solid and liquid stoma waste, which can clog the filter over long periods of exposure, resulting in undesirable pouch distension or ballooning. Such a configuration may be particularly useful, for example, for open pouches where a user may use the same pouch for extended periods of time.
[0039] In other embodiments, the filter arrangement may comprise an odor filter disposed on the inner surface of the pouch's outer wall. In such embodiments, the vent may comprise one or more slits, openings, etc., in the outer wall of the ostomy pouch. The slit may be disposed adjacent to the odor filter, for example, adjacent to the rear surface of an odor filter that is glued or otherwise bonded to the outer wall of the pouch. While suffering from the disadvantage that liquid and solid stomal waste may come into contact with the odor filter for extended periods, embodiments in which the odor filter is disposed on the interior of the pouch may provide a cost-effective solution and may be particularly suitable for use with, for example, closed pouches, which are designed for much shorter wear periods than open pouches. Here, the filter may be exposed to stomal waste, but for a much shorter period of time, potentially reducing the likelihood of clogging before the end of its useful life.
[0040] The filter arrangement may include a pre-filter. The pre-filter may be configured to control the amount of stoma waste that comes into contact with the vent and / or odor filter. For example, the pre-filter may be advantageously configured to prevent or at least reduce the level of solid or liquid stoma waste that can come into contact with the vent and / or odor filter. The filter arrangement may be provided within or associated with the outer wall of the ostomy pouch. For example, the vent may have one or more slits, openings, or the like, in the outer wall of the ostomy pouch. The filter arrangement may be provided within or associated with the upper section of the pouch, which may be at the opposite end of the pouch from the drain.
[0041] The filter arrangement may be provided with a filter cap. The filter cap may be provided, for example, on the outer surface of the pouch's outer wall or, if present, on the outer surface of the outer comfort layer, and may be disposed around an odor filter forming part of the pouch's filter arrangement. The filter cap may protect the filter arrangement, and in particular may be provided and operable to protect the odor filter during use. The filter cap may include one or more openings or slits therein, for example, one or more S-shaped slits, which allow gas to pass through.
[0042] The filter arrangement may further include a filter cover label. The filter cover label may comprise a removable part that can be placed over the filter cap during use and seal the opening / slit therein. This is particularly useful, for example, when the ostomate plans to swim, bathe, or shower. The label can prevent water from entering through the opening / slit in the cap, thereby preventing water from clogging the odor filter.
[0043] In embodiments, the cavity may include one or more sections, such as an upper section and a lower section. The cavity may also include a waist section located between the upper and lower sections. The waist section may also have a minimum width that is smaller than the maximum width of the upper and / or lower sections.
[0044] In an embodiment, the cavity may have an upper section, a lower section, and a waist section located between the upper and lower sections.
[0045] The maximum widths of the upper and lower sections may be equal (or substantially equal). The maximum widths of the upper and lower sections may be different. For example, in some embodiments, the maximum width of the upper section may be greater than the maximum width of the lower section.
[0046] The maximum width of the upper and / or lower sections may be, for example, 120 mm to 170 mm, or 130 mm to 160 mm, or 135 mm to 150 mm, or 135 mm to 140 mm, or 140 mm to 145 mm. In an exemplary embodiment, the maximum width of the upper section may be approximately 142 mm, and the maximum width of the lower section may be between 137 mm and 139 mm.
[0047] The minimum width of the waist section may be, for example, 105mm to 135mm, or 110mm to 130mm, or 110mm to 125mm, or 115mm to 130mm, or 120mm to 135mm, or 115mm to 120mm, or 120mm to 125mm, or 125mm to 130mm, or approximately 120mm. In exemplary embodiments, the minimum width of the waist section may be approximately 129mm, 119mm, or 109mm.
[0048] The minimum width of the waist section may be 5 mm to 30 mm smaller than the maximum width of the lower section, or 10 mm to 20 mm smaller than the maximum width of the lower section, or 15 mm to 20 mm smaller than the maximum width of the lower section. The minimum width of the waist section may be, for example, 10 mm to 35 mm smaller than the maximum width of the upper section, or 15 mm to 30 mm smaller than the maximum width of the upper section, or 20 mm to 25 mm smaller than the maximum width of the upper section.
[0049] The minimum width of the waist section may be between 75% and 95% of the maximum width of the lower section, or between 80% and 90% of the maximum width of the lower section, or between 83% and 88% of the maximum width of the lower section.
[0050] The minimum width of the waist section may be between 73% and 92% of the maximum width of the upper section, between 75% and 85% of the maximum width of the upper section, or between 80% and 85% of the maximum width of the upper section.
[0051] The pouch may have a length of between 150mm and 300mm when the deployable drain is in the deployed position and / or a length of between 200mm and 240mm when the deployable drain is in the stowed position.
[0052] For example, the pouch can have a length of 230 mm to 300 mm, optionally a length of 240 mm to 290 mm, optionally a length of 256 mm or 286 mm when the ostomy appliance drain is in the deployed configuration. The open ostomy appliance may have a length of 180 mm to 240 mm, optionally a length of 190 mm to 230 mm, optionally a length of 194 mm, 208 mm, 224 mm or 230 mm when the ostomy appliance drain is in the collapsed configuration.
[0053] Opposing edges of the waist section may be concavely curved. Opposing edges of the waist section may have a radius of curvature or a blend of radii of curvature, where the or each radius of curvature may be, for example, between 20 mm and 60 mm, or between 30 mm and 50 mm, or between 35 mm and 45 mm. The radius of curvature may be approximately 40 mm. Alternatively, the left and right ends of the waist section may each have a radius of curvature or a blend of radii of curvature, where each radius of curvature is between 30 mm and 80 mm, optionally between 35 mm and 75 mm, optionally between 40 mm and 70 mm, and optionally 60 mm. Opposing edges of the waist section may be configured in substantially the same manner or shape, for example, as mirror images of each other.
[0054] The upper section and / or the lower section may have a generally rounded shape. For example, the upper section may have a continuously curved edge extending from a first edge (e.g., left end) of the waist section to a second edge (e.g., right end) of the waist section. The lower section may include a continuously curved edge extending from a first edge (e.g., left end) of the waist section to a second edge (e.g., right end) of the waist section.
[0055] The continuously curved edges of the upper and / or lower sections may be convexly curved. The continuously curved edges of the upper and / or lower sections may be free of inflection points or abrupt changes in contour. The continuously curved edges of the upper and / or lower sections may have a radius of curvature or a blend of radii of curvature, where each radius of curvature may be, for example, 40 mm to 80 mm, or 55 mm to 75 mm, or 60 mm to 73 mm, or 65 mm to 70 mm.
[0056] In embodiments, the upper and / or lower sections may be elongated and may have both rounded and generally rectangular portions. The generally rectangular portions may have opposing straight edges. The rounded portions may be located away from the waist section. The generally rectangular portions may be located proximal to the waist section.
[0057] The junctions between the upper and / or lower sections and the waist section may be defined by a single inflection point between the left end of the upper or lower section and the left end of the waist section, and a single inflection point between the right end of the upper or lower section and the right end of the waist section.
[0058] The waist section's minimum width may be located 90mm to 125mm, or 95mm to 120mm, or 100mm to 115mm, or 105mm to 115mm, or about 99mm, or 109mm, or 119mm from the top edge of the ostomy pouch. The waist section's minimum width may be located 90mm to 125mm, or 95mm to 120mm, or 100mm to 115mm from the bottom edge of the ostomy pouch. The distance may be between 45% and 60% of the pouch length, or between 47% and 57% of the pouch length, or between 50% and 55% of the pouch length.
[0059] The pouch may have one or more additional sections, such as a third section and / or a fourth section. The additional section or sections may be separated from one or more other sections of the pouch by respective waist sections. The waist sections may also have a minimum width that is smaller than the maximum width.
[0060] According to one aspect of the present invention, there is provided a method for collecting stomal output using an ostomy pouch according to any of the aspects described herein. The method may include attaching the ostomy pouch to an ostomate's stoma. If the pouch comprises a one-piece ostomy pouch, the ostomy pouch can be attached to the stoma using an ostomy wafer on the pouch. Alternatively, the method may comprise attaching an ostomy wafer on a two-piece body-fitting component to the stoma; and attaching the pouch to the body-fitting component. The pouch can be attached to the body-fitting component before attachment to the stoma, or the ostomy wafer can be attached after attachment to the stoma. If the ostomy pouch comprises an open or drainable pouch, the method may comprise draining the stomal output from the ostomy pouch. [Brief explanation of the drawings]
[0061] In order that the present invention may be more clearly understood, one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, in which: [Figure 1A] FIG. 2 is a side perspective view of one embodiment of an ostomy pouch according to the present invention in a deployed position, illustrating the flow of the ostomy pouch. [Figure 1B] FIG. 1B is another side perspective view of the ostomy pouch of FIG. 1A showing the drain in a stowed position. [Figure 2A] FIG. 1B is a side perspective view showing section A of FIG. 1A. [Figure 2B] 1B is a side perspective view showing section B of FIG. 1B. [Figure 3]FIG. 2 is an exploded perspective view of the ostomy pouch shown in the previous figure. [Figure 4A] Side cross-sectional view of Figure 2A. [Figure 4B] Side cross-sectional view of Figure 2B. [Figure 5] FIG. 2 is a side perspective view of a second embodiment of an ostomy pouch of the present invention. [Figure 6A] FIG. 10 is a side perspective view of a third embodiment of an ostomy pouch according to the present invention in a deployed position, showing the outflow of the ostomy pouch. [Figure 6B] 6B is another side perspective view of the ostomy pouch of FIG. 6A showing the drain in a stowed position. [Figure 7] FIG. 6C is an exploded perspective view of the ostomy pouch shown in FIGS. 6A and 6B. DETAILED DESCRIPTION OF THE INVENTION
[0062] As used herein and throughout the specification, the term "stoma waste" refers to any gas, liquid, or solid produced by an ostomate that may be secreted from the stoma or that exits the ostomate's stoma. Stoma waste may consist of gas, fluid, liquid, and / or solid stoma waste.
[0063] The term "stoma" refers to a bodily opening. Generally, a stoma is a surgical opening in the torso. In some cases, the term "stoma" also refers to an internal tissue, organ, or portion thereof exposed by the opening. By way of non-limiting example, 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.
[0064] The term "ostomate" refers to a subject who may utilize an ostomy pouch as described herein. Although an ostomate typically refers to a subject with a surgical opening, as used herein, "ostomate" can also refer to a subject with a stoma, whether the stoma is created by surgery or other means.
[0065] The term "user" may refer to the ostomate or another person assisting the ostomate, for example, in emptying the stoma waste from the cavity.
[0066] The ostomy pouches disclosed herein may be used to manage a stoma created by, for example, an esophagostomy, gastrostomy, cholecystostomy, choledochostomy, colostomy, colostomy, duodenostomy, ileostomy, jejunostomy, appendixostomy, tracheostomy, urostomy, nephrostomy, ureterostomy, or cystostomy. The ostomy pouches disclosed herein may be used with additional devices, including, but not limited to, shunts, catheters, plugs, or fecal management systems.
[0067] As used herein, the location and orientation of features may be described in terms of the ostomy pouch being "in use" or "orientation as it would be in use." Such terms refer to the intended orientation of the ostomy pouch when adhered or otherwise secured to the ostomate's body, e.g., when the ostomate is standing, regardless of whether the ostomy pouch is currently in such use or the ostomate's actual position. The terms "upper" and "lower," and related terms, refer to the relative positions of a portion or portions of the ostomy pouch when oriented as in use. For example, a section of the ostomy pouch may be referred to as the "upper" section of the ostomy pouch. In such an example, that section would be intended to be the top (upper or lower) portion of the ostomy pouch when worn on the body of a standing ostomate. However, those skilled in the art will appreciate that the section may not always be at the top before application to the ostomate, and furthermore, the section may not always be at the top if the ostomate is in a non-upright position, such as a recumbent position, when applied.
[0068] The terms "left side" and "right side" and related terms may refer to the ostomy pouch as viewed from the rear (e.g., as shown in Figure 1A). Thus, by way of illustration, in a situation where the ostomy pouch is attached to the anterior torso of the ostomate, the "left side" edge of the ostomate appliance would be toward the left side of the ostomate.
[0069] The terms "concave" and "convex" and related terms refer to the shape of features of the ostomy pouch when viewed from the exterior of the ostomy pouch. Thus, by way of example, a circular ostomy wafer would be considered to have a convex periphery.
[0070] The terms "inside" and "outside" refer to the relative position of a part or parts of the ostomy pouch with respect to the ostomate's body when the ostomy pouch is attached to the ostomate's body (e.g., adhesively or otherwise). "Inside" refers to a position relatively closer to the body than the "outside" of the ostomate. "Outside" refers to a position relatively farther from the ostomate's body than the comparable position, which is "inside."
[0071] Ostomy pouches are typically attached to the ostomate's body by an ostomy wafer containing one or more adhesive layers. Ostomy wafers typically have a stoma opening, called a starter hole, and may be cut to the required size by the user before application. Ostomy wafers typically contain an adhesive layer on the body-facing side to adhere the ostomy wafer to the ostomate's body. A release liner usually covers the body-facing side of the ostomy wafer and is removed by the user before application to the skin. As used herein, the term "ostomy wafer" may be used interchangeably with the terms "adapter," "wafer," "base plate," or "layered adhesive wafer." The "ostomy wafer," "adapter," "wafer," "base plate," or "layered adhesive wafer" can form a skin barrier between the ostomate and the pouch. As used herein, the term "ostomy wafer" includes ostomy wafers for both "two-piece appliances" and "one-piece appliances."
[0072] A "two-piece pouch" refers to an ostomy pouch in which the ostomy wafer forms part of a separate body-fitting component that is attached to the pouch by a releasable bond. A two-piece pouch allows the body-fitting component to be separated from the pouch without damage, so that at least one of the components remains functionally usable. For example, the body-fitting component may remain attached to 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, and the ostomy wafer cannot be easily separated without risk of damaging the appliance. One-piece pouches are intended for use as a single unit.
[0073] Ostomy pouches may generally be configured as "closed" or "open" pouches. As used herein, a "closed pouch" refers to an ostomy pouch in which stoma waste is not intended to flow out of the cavity. Thus, a closed pouch is typically configured as a single-use, disposable, non-reusable pouch. As used herein, an "open pouch" refers to an ostomy pouch in which stoma waste can be drained from the cavity and the pouch reused. Thus, an open pouch can be configured as a reusable pouch so that it can be reused and emptied multiple times while still attached to the body. In an open pouch, stoma waste may be drained intermittently, triggered by the ostomate's actions, or intermittently or continuously because the cavity is fluidly connected to a drainage pipe, e.g., a nighttime drainage line.
[0074] While the use of a closed or open pouch is a matter of user preference, depending on the needs of a particular ostomate and the location of the ostomate's stoma, either a closed or open pouch may be more appropriate. For example, for stomas created by ileostomy, stoma output tends to be looser and easier to pass, so an open pouch may be more appropriate. For stomas created by colostomy, stoma output tends to solidify and may not be easily passed by the user. In such cases, a closed pouch may be more appropriate.
[0075] Conditional language such as "can," "could," "may," or "might," unless otherwise indicated or as understood within the context in which it is used, is generally intended to convey that certain embodiments include certain features, elements, and / or steps and other embodiments do not. Thus, such conditional language is generally not intended to imply that the features, elements, and / or steps are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic that, in conjunction with user input or prompting, determines whether those features, elements, and / or steps are included in or performed in any particular embodiment.
[0076] 1A-4B illustrate an ostomy pouch 10 having an inner wall 18b and an outer wall 20b sealed around at least a portion of its periphery to define a cavity for containing stoma waste. The pouch 10 is an open pouch with a single, continuous seal about the periphery of the pouch 10, except for a drainage opening 35, described in detail below. The cavity includes a first, upper section 12 and a second, lower section 14, which are generally rounded and have convex, curved edges. The upper and lower sections 12, 14 are separated by a waist section 13, which is narrower than the upper and lower sections 12, 14. A deployable drain 32 (described in more detail below) extends from the lower section 14 of the pouch 10. It will be understood that the pouch shape and configuration of the pouch 10 shown in the figures are provided by way of example only, and that other configurations are contemplated and within the scope of the present invention.
[0077] The inner and outer walls 18b, 20b are formed from flexible plastic sheet material. The pouch 10 also includes inner and outer comfort layers 18a, 20a overlying the respective inner and outer walls 18b, 20b. The comfort layers 18a, 20a are formed from a woven, fabric material and define the exterior surface of the pouch 10. In the illustrated embodiment, the inner surface of the fabric layer is coated with a web of hot melt adhesive (EVA in this example) so that the inner comfort layer 18a, inner wall 18b, outer wall 20b, and outer comfort layer 20a can be joined in a single joining operation, here by welding.
[0078] The outer comfort layer includes first and second portions 20a', 20a" joined to the outer wall 20b such that the first portion 20a' overlaps the second portion 20a" in the overlap region. The first and second portions 20a', 20a" are separable from each other in the overlap region to form a window opening for viewing the cavity. In the illustrated embodiment, the second portion 20a" overlaps the first portion 20a'; however, in some cases, the outer comfort layer 20a of the pouch 10 may be configured in the reverse sense, with the first portion 20a' overlapping the second portion 20a".
[0079] The inner wall 18b includes an opening therein that defines a stoma entrance 48 within the pouch 10 for receiving stoma waste into the cavity, where the stoma entrance 48 is located within the upper section 12 of the pouch 10. An opening 46 is provided in the inner comfort layer 18a that defines a wafer opening through which the ostomy wafer 24 is positioned and that, during use, is positioned over the stoma entrance 48.
[0080] The ostomy wafer 24 includes a central opening 22, an adhesive region 28, and a removable release liner 25 to expose the adhesive region 28, which can then be used to secure the pouch 10 to and around the ostomate's stoma during use. The release liner 25 is provided with a tab 26 to assist the user in removing the release liner 25. The ostomy wafer 24 is suitably secured to the interior wall 18b, for example, through the use of an additional adhesive region. The adhesive region 28 is moldable to the extent that it can be manipulated to adjust the shape and size of the central opening 22 depending on the size and shape of the ostomate's stoma. As used herein and throughout, the term "moldable" is intended to refer to a component, here the adhesive region 28, that can be molded under the application of force (e.g., rolling) by a user. In an alternative arrangement, the adhesive region may be configured to be shaped to fit the stoma, for example, by a user cutting the region to provide the required size and shape of the central opening 22.
[0081] A separation filter 50 is provided within the pouch 10, positioned between the inner and outer walls 18b, 20b and separating the cavity into two cavity compartments. The separation filter 50 is fluid-permeable and operable to filter fluid (i.e., gaseous and liquid) stoma waste from solid stoma waste. Specifically, during use, stoma waste is received into the first chamber of the cavity via the stoma entrance 48. This stoma outlet may be both liquid and solid. The separation portion 50 is positioned to retain solid stoma waste in the first chamber adjacent the inner wall 18b, while allowing fluid stoma waste to pass to the second chamber adjacent the outer wall 20b. In the illustrated embodiment, the separation filter 50 is substantially the same shape and size as the inner and outer walls 18b, 20b, and is sealed around its periphery (except for the area adjacent the drain 32) to the inner and outer walls 18b, 20b.
[0082] The illustrated embodiment further includes a filter system comprising a vent 30 in the outer wall 20b for venting gaseous stoma waste from the cavity. This advantageously maximizes the pouch 10's capacity for receiving liquid and solid stoma waste and prevents "expansion" or "ballooning" of the pouch 10, which can adversely affect the pouch's discreetness during use. The filter system is located within the upper section 12 of the pouch. The vent 30 is equipped with an odor filter (e.g., a charcoal or activated carbon filter) to reduce the emission of unpleasant odors from the cavity. Here, the odor filter is substantially circular, although it will be understood that other shapes and configurations of odor filters are equally applicable. The filter is positioned on the outer surface of the outer wall 20b adjacent to the vent 30 so that gaseous stoma waste released through the vent 30 is released from the pouch 10 through the filter.
[0083] In the illustrated embodiment, a slit 52 is provided in the outer comfort layer 20a adjacent to the location of the vent 30 so that gaseous stoma waste released through the vent 30 can be released from the pouch 10. Gas can escape through the gap between the first and second portions 20a', 20a'', and therefore, in some cases, the slit 52 may not be provided.
[0084] As mentioned above, pouch 10 is an "open" pouch 10 that includes a drain 32 for draining stoma waste from the cavity. Drain 32 has a drain opening 35 formed in the unsealed portion of the periphery of pouch 10, i.e., the area around inner and outer walls 18b, 20b that are not sealed together. Stoma waste may be released from the cavity through drain opening 35 during use.
[0085] The drain 32 is integral with the inner and outer walls 18b, 20b and forms an elongated portion of the pouch 10 that extends downwardly from the lower edge of the lower section 14. The inner and outer comfort layers 18a, 20a are not provided over the drain 32. Similarly, the separation filter 50 is aligned with the inner and outer comfort layers 18a, 20a and does not extend into the drain 32. Here, the separation filter 50 is not sealed at its lowermost end to the inner and outer walls 18b, 20b, allowing stoma waste to drain through the drain 32 from both the first and second cavity chambers of the cavity.
[0086] The drain 32 is a deployable drain 32 that is movable between a deployed position (shown in FIG. 1A) and a retracted position (shown in FIG. 1B). When the drain 32 is moved to the retracted position, the drain outlet 35 effectively blocks the stoma waste from leaving the cavity. Specifically, the drain 32 is generally foldable about fold lines 37 and 39 on the drain 32 between the deployed and retracted positions. The fold lines define the drain 32 into first, second, and third segments 33, 34, and 36, which can be folded onto one another about the fold lines 37 and 39, for example, when moving from the deployed position to the retracted position. The relative positions of the first, second, and third segments 33, 34, and 36 of the drain when in the retracted position are shown in FIG. 4B.
[0087] The pursing strips 38a, 38b are provided on opposite sides of the drain 32, with the first pursing strip 38a provided on the inner wall 18b at a portion defining the first segment 33 of the drain 32 and the second pursing strip 38b provided on the outer wall 20b at a portion defining the second segment 34 of the drain 32. The pursing strips 38a, 38b provide localized stiffness to the drain 32 and assist in opening the drain opening 35 during use. Specifically, the pursing strips 38a, 38b may be squeezed laterally to arch the pursing strips 38a, 38b (and thus the inner and outer walls 18b, 20b, respectively) in opposite directions, thereby opening the drain opening 35.
[0088] The pursing strips 38a, 38b are generally rectangular but include cutout areas at their corners, as specifically shown in FIGS. 1A and 2A . The cutout areas of the first pursing strip 38a align with corresponding cutout areas of the second pursing strip to form semicircular interaction areas 64a, 64b within the drain 32. The interaction areas 64a, 64b define locations on the drain 32 where a user can interact to open the drain outlet 35, specifically by squeezing opposing edges of the pursing strips 38a, 38b toward each other and bending or arching the strips away from each other. During use, the user / ostomate can open the drain outlet 35 by, for example, performing a pinching motion using their thumb and index finger on the opposing interaction areas 64a, 64b.
[0089] The drain 32 includes a first fastener in the form of a hook strip 40 attached to the outer surface of the inner wall 18b. Specifically, the hook strip 40 is attached to the outer surface of the inner wall 18b, at a portion thereof that defines the third segment 36 of the drain 32. A corresponding second fastener 42 is attached to a flap 44 attached to the outer surface of the outer comfort layer 20a (e.g., by welding to the flap with a hot melt adhesive or by adhesively securing the flap with, for example, adhesive tape). The second fastener is also in the form of a hook strip 42.
[0090] As specifically shown in FIGS. 1A-2B, the flap 44 extends substantially the entire width of the pouch 10 toward the sealed periphery of the pouch 10. The flap 44 does not overlap the sealed edge of the pouch 10 to avoid interfering with the seal, primarily to avoid interfering with the sealing process during the manufacture of the pouch 10. The flap 44 includes a pair of opposing curved edges 60a, 60b that correspond to the shape and configuration of the curved continuous edge of the pouch 10, thereby maximizing the coverage of the flap 44 against the outer comfort layer 20a. The flap 44 further includes a flange 62 that projects downwardly (in the "in use" orientation) from the flap 44. As specifically shown in FIGS. 1B and 2B, the flange 62 is positioned to cover a portion of the drain 32 when in the retracted position, allowing the flap 44 to provide greater coverage of the drain.
[0091] During use, the drain 32 is folded upward about fold lines 37 and 39, away from the ostomate, first folding along fold line 37 to overlap the first segment 33 adjacent to the second segment, and then folding the first and second segments 33 and 34 about fold line 39 to overlap the third segment 36, thereby moving the drain 32 from the deployed position to the stowed position. Finally, the drain 32 is folded again to overlap a portion of the outer comfort layer 20a, as shown in FIG. 1B, and the flap 44 is folded downward to engage the second fastener 42 with the first fastener 40, holding the drain 32 in the stowed position. As shown in FIGS. 1B and 2B, in the stowed position, the flap 44 does not entirely cover the stowed drain 32. Rather, the drain 32 is only partially covered by the flap 44, with one or more portions of the drain 32 remaining uncovered and visible during use. Specifically, edge regions 31 a, 31 b remain visible along with drain 32 in the retracted position. Edge regions 31 a, 31 b that are visible in the retracted position form part of inner wall 18 b, which is opaque, as described below. This advantageously prevents visibility into the interior of drain 32 when retracted.
[0092] The drain 32 moves from the stowed position to the deployed position in the reverse order.
[0093] As described herein, the drain 32 is formed from portions of the inner and outer walls 18b, 20b of the pouch 10. The portion of the inner wall 18b defining the drain 32 is substantially opaque. Thus, when the drain 32 is in a folded, stowed position away from the ostomate, the inner wall 18b forms an opaque outer surface of the folded drain 32. By folding the drain 32, together with the flap 44, over the outer surface of the opaque comfort layer 20a, the opaque outer surface of the drain 32 prevents the contents of the pouch 10 from being seen when the drain 32 is in the stowed position. This is beneficial from a user's perspective, as pouch contents can be unsightly and ostomates may wish to conceal them during normal use of the pouch. At the same time, the portion of the outer wall 20b defining the drain 32 is transparent. Thus, when positioned, the outermost surface of the drain 32 is transparent, allowing the ostomate / user to see the contents of the pouch 10, particularly the contents passing through the drain 32 during the emptying process. Advantageously, this allows for greater control over the ejection process.
[0094] FIG. 5 shows a second embodiment of a pouch 110 according to the present invention.
[0095] Where features of pouch 110 are equivalent to features of pouch 10, like reference numerals are used. Features equivalent to pouch 10 described herein are configured in the same manner in pouch 110 unless otherwise specified herein. See also the previous description for common features.
[0096] The pouch 110 is formed with inner and outer walls sealed around their peripheries to define a cavity for containing stoma waste. Again, the cavity includes a first upper section 112 and a second lower section 114, which are generally rounded in shape with convex curved edges. The upper and lower sections 112, 114 are separated by a waist section 113 that is narrower than the upper and lower sections 112, 114. The pouch 110 is sized approximately equal to the dimensions of the pouch 10 described herein.
[0097] Similar to pouch 10, the inner and outer walls are formed from a flexible, plastic sheet material, with inner and outer comfort layers 118a and 118b formed from a woven, fabric material overlying the inner and outer walls, respectively. Again, the upper section 112 of pouch 110 is provided with a stoma entrance for receiving stoma waste into the cavity, and an ostomy wafer 124 is positioned within the opening of inner comfort layer 118a to cover the stoma entrance during use. The ostomy wafer 124 is constructed in the same manner as ostomy wafer 24 described above. The pouch also includes a deployable drain 132 configured substantially similarly to drain 32 of pouch 10. Similar to pouch 10, deployable drain 132 is movable between a deployed position (shown in FIG. 5 ) and a stowed position by folding drain 132 about various fold lines 137, 139 and securing it in place with fasteners 140, 142.
[0098] Pouch 110 differs in that lower section 114 of pouch 110 has a different shape, and in particular is more elongated. Here, lower waist section 114 of pouch 110 includes straight edges 115a, 115b extending from waist-waist section 113 to define a generally rectangular portion of lower waist section 114 adjacent waist-waist section 113 and a generally rounded waist section at the bottom end of pouch 110. Elongated lower waist section 114 advantageously provides a greater capacity for storing stoma waste therein.
[0099] 6A, 6B and 7 show a third embodiment of a pouch 210 according to the present invention.
[0100] Where features of pouch 210 are equivalent to features of pouch 10, like reference numerals are used. Features equivalent to pouch 10 described herein are configured in the same manner in pouch 210 unless otherwise specified herein. See also the previous description for common features.
[0101] The pouch 210 is formed by inner and outer walls that define a cavity for containing stoma waste and seal the periphery thereof. Again, the cavity includes a first upper section 212 and a second lower section 214, which have a generally rounded shape with convexly curved edges. The upper and lower sections 212, 214 are separated by a waist section 213 that is narrower than the upper and lower sections 212, 214. The pouch 210 of the third embodiment, while similar in shape, is slightly flatter than the pouches 210 of the previous embodiments. The "standard" size is 194 mm long with the drain retracted and 256 mm long with the drain deployed. (The "large" size is assumed to be similar in shape to the second embodiment, with a retracted length of 224 mm and a deployed length of 286 mm.) Another difference in shape is that the waist radius in this example is 60 mm. Of course, one skilled in the art would have no problem determining the appropriate size and shape.
[0102] Similar to pouch 10, the inner and outer walls 218b, 220b are formed from a flexible, plastic sheet material, woven fabric, or cloth material, with inner and outer comfort layers 218a, 220a covering the respective inner and outer walls. Again, the upper section 212 of pouch 210 is provided with a stoma entrance for receiving stoma waste into the cavity, and an ostomy wafer 224 is positioned within the opening in the inner comfort layer 218a to cover the stoma entrance during use. The ostomy wafer 224 is configured in the same manner as the ostomy wafer 24 described herein. The pouch also includes a deployable drain 232 configured in substantially the same manner as the drain 32 of pouch 10. Similar to pouch 10, deployable drain 232 is similarly movable between a deployed position (shown in FIG. 6A) and a stowed position (shown in FIG. 6B) by folding drain 232 about various fold lines and securing it in place with fasteners 240, 242.
[0103] In addition to being different in size, the pouch 210 of the third embodiment differs in that it does not include a separate filter running the length of the pouch, but rather has only a separator panel 250 located between the inner and outer walls 218b, 220b of the upper half of the pouch to prevent debris from blocking the filter 230 through which stoma gas is vented. Also, the outer comfort layer 220a does not include a slit; instead, gas escapes through the gap between the upper and lower comfort layers 220a.
[0104] However, the most notable difference from the standpoint of the present invention is that in this third embodiment, as specifically shown in Figures 6A, 6B, and 7, a flap 244 provided with one of the fasteners 242 extends across the entire width of the pouch 210, all the way to the sealed periphery of the pouch 210. The flap 244 covers the sealed edge of the pouch 210 and is attached by adhesive, provided in this embodiment as adhesive tape, after the sealing process during manufacture of the pouch 210. The flap 244 includes a pair of opposing curved edges 260a, 260b that correspond not only to the shape and configuration of the curved continuous edge of the pouch 210, but also to the width and position of the curved continuous edge of the pouch. This maximizes the coverage of the outer comfort layer 220a by the flap 244 and provides a streamlined pouch profile. The flap 244 is provided with a flange 262 that projects downwardly from the flap 244 (in the "in use" orientation) and covers a portion of the drain 232 when in the retracted position, thereby increasing the coverage of the drain by the flap 244.
[0105] In use, the drain 232 is moved in exactly the same way as in the first embodiment, and like the first embodiment (as shown in Figures 6B and 6B for this third embodiment), in the retracted position the flaps 244 do not cover the entire retracted drain 232, leaving edge areas visible in the retracted position, these edge areas consisting of parts of the inner wall 218b which are of course opaque. This advantageously prevents the interior of the drain 32 from being seen when it is retracted.
[0106] One or more embodiments have been described above by way of example only: many variations are possible without departing from the scope of protection set forth in the appended claims.
Claims
1. a cavity for containing stoma waste defined by an inner wall (18b, 218b) and an outer wall (20b, 220b) of flexible sheet material sealed about its periphery, and a deployable drain (32, 132, 232) for draining the stoma waste from said cavity; a comfort layer (18a, 20a, 118a, 218a, 220a) at least partially disposed on the outer surface of the inner and / or outer wall of the flexible sheet material; a fastener arrangement configured to hold the deployable drain (32, 132, 232) in a stowed position, the fastener arrangement including a first fastener (40, 140, 240) and a second fastener (42, 142, 242) disposed on the inner wall (18b, 218b) or the outer wall (20b, 220b) of the ostomy pouch (10, 110, 210); at least a portion of the inner wall (18b, 218b) defining the deployable drain (32, 132, 232) is substantially opaque, and at least a portion of the outer wall (20b, 220b) defining the deployable drain (32, 132, 232) is at least partially transparent; the comfort layer (18a, 20a, 118a, 218a, 220a) is substantially opaque, the first fastener (40, 140, 240) is disposed on an outer surface of the comfort layer, and further, the deployable drain (32, 132, 232) is movable between a deployed position for draining the stoma waste from the cavity and a retracted position for retracting the deployable drain (32, 132, 232), wherein in the retracted position at least a portion of the drain overlies a portion of the comfort layer (18a, 20a, 118a, 218a, 220a); Ostomy pouches (10, 110, 210).
2. the drain (32, 132, 232) comprises an elongated extension of the inner wall (18b, 218b) and outer wall (20b, 220b) extending from a drain inlet of the cavity, and an outlet at the distal end of a drain channel (35, 135) through which stoma waste from within the cavity exits the pouch; 2. The ostomy pouch (10, 110, 210) of claim 1.
3. the deployable drain (32, 132, 232) is movable between the stowed position and the deployed position by rolling or folding the drain (32, 132, 232); Preferably, the drain (32, 132, 232) is movable from the deployed position to the stowed position in use by folding and / or rolling the drain (32, 132, 232) in an upward direction away from the ostomate.
3. An ostomy pouch (10, 110, 210) according to claim 1 or claim 2.
4. the second fastener (42, 142, 242) is disposed at a portion of the inner wall (18b, 218b) of the pouch that defines at least a portion of the drain; An ostomy pouch (10, 110, 210) according to any one of claims 1 to 3.
5. the first fastener (40, 140, 240) includes a flap (44, 144, 244) secured to the comfort layer (18a, 20a, 118a, 218a, 220a); An ostomy pouch (10, 110, 210) according to any one of claims 1 to 4.
6. 6. The ostomy pouch (10, 110, 210) of claim 5, wherein the flap (44, 144, 244) is provided on a comfort layer (20a, 220a) that, in use, overlies the outer wall (20b, 220b) of the pouch away from the ostomate.
7. The flaps (44, 144, 244) are configured to correspond to one or more contours of the ostomy pouch (10, 110, 210).
7. An ostomy pouch (10, 110, 210) according to claim 5 or claim 6.
8. the pouch has one or more curved edges, and the flaps are similarly curved to correspond to the contours of the curved edges of the pouch; the flap extends at least substantially across the entire width of the pouch; 8. The ostomy pouch of claim 7.
9. the drain includes a pair of pursing strips (38a, 38b, 138a, 138b), each strip (38a, 38b, 138a, 138b) adhesively or otherwise secured to the inner wall (18b, 218b) or outer wall (20b, 220b) of the pouch; An ostomy pouch (10, 110, 210) according to any one of claims 1 to 8.
10. the drain is divided into two or more segments (33, 34, 36) defined by fold lines (37, 39, 137, 139) that allow the drain (32, 132) to fold as it moves between the deployed and stowed positions; Preferably, the drain segments (33, 34, 36) are folded sequentially onto one another when moving from the deployed position to the stowed position. An ostomy pouch (10, 110) according to any one of claims 1 to 9.
11. The drain (32, 132) is divided into three segments (33, 34, 36), a first pursing strip (38a, 138a) is disposed on the inner wall (18b) of the pouch and defines at least a portion of the first segment (33) of the drain (32, 132), a second pursing strip (38b, 138b) is disposed on the outer wall (20b) of the pouch (10, 110) and defines at least a portion of the second segment (34) of the drain (32, 132), and the second fastener (42, 142) is provided on the inner wall (18b) of the pouch (10, 110) and defines at least a portion of the third segment (36) of the drain (32, 132).
11. An ostomy pouch (10, 110) according to claim 10.
12. In the stowed position, at least a portion of the deployable drain (32, 132, 232) is visible. An ostomy pouch (10, 110, 210) according to any one of claims 1 to 11.
13. in use, in the stowed position, the deployable drain (32, 132, 232) is partially covered by the flap (44, 144, 244), but also has one or more portions that remain uncovered and thereby visible; the or each portion visible in the stowed position includes a region or regions of the drain (32, 132, 232) adjacent to one or more edges of the drain (32, 132, 232); An ostomy pouch (10, 110, 210) according to claim 12 when dependent on any of claims 5 to 8.
14. the or each portion visible in the storage position includes a portion of the opaque inner wall (18b, 218b) of the pouch that defines the drain (32, 132, 232); 14. The ostomy pouch (10, 110, 210) according to claim 13.
15. the comfort layer (18a, 20a, 118a, 218a, 220a) does not cover the inner wall (18b, 218b) or outer wall (20b, 220b) of the pouch in a portion of the inner wall (18b, 218b) and / or outer wall (20b, 220b) that defines the drain; An ostomy pouch (10, 110, 210) according to any one of claims 1 to 14.
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