Ostomy pouch

Abstract

The present invention relates to an ostomy pouch 10, 110. The pouch 10, 110 includes an inner wall 18b, 118b and an outer wall 20b, 120b sealed around at least a portion of their perimeter to define a cavity for containing stoma waste. An entrance 22, 122 is provided in the cavity for receiving stoma waste from an ostomate during use. The cavity includes multiple sections 12, 14, 16, 112, 114, 116 separated by waist sections 13, 15, 113, 115. The maximum width of the sections 12, 14, 16, 112, 114, 116 is greater than the minimum width of the waist sections 13, 15, 113, 115.

Description

Technical Field of the Invention

[0001] The present invention relates to an ostomy pouch having a cavity for containing stoma excrement. Background of the Invention

[0002] An ostomy pouch can be used to collect and hold stoma excrement from a stoma formed in the body of an ostomate. Generally, a stoma is a surgical opening in the torso of the ostomate's body, although it may also refer to internal tissue, organs, or a part thereof exposed by the opening. An ostomy pouch typically takes the form of sealing a pair of walls to form a cavity into which stoma excrement is discharged from the ostomate through the formed stoma.

[0003] One exemplary prior art urostomy pouch is disclosed in GB2268882. The pouch includes a front wall and a rear wall joined by a peripheral weld and includes an additional pair of inwardly extending V-shaped welds that define a check valve. The V-shaped welds can be seen as defining one waist between the first (upper) section and the second (lower) section of the pouch.

[0004] Another exemplary urostomy pouch is disclosed in EP1068848. The bag consists essentially of a first upper curved arcuate portion and a second lower arcuate portion, and at least one of the arcuate portions has a maximum width that is greater than the width of the "waist" portion where the two portions meet. In the disclosure, this arrangement is described as being in the shape of an "8", but it is characteristic that the upper section of the "8" is not wider than the "slight waist".

[0005] Considering the nature and use of an ostomy pouch, it is desirable that the pouch can be worn as simply and unobtrusively as possible for ostomates. To enhance the convenience of ostomy, it is also advantageous that the pouch can be worn for a long period of time. However, in order to increase the usage time of the pouch, generally it is necessary to increase the volume of the pouch, which may be disadvantageous in terms of the inconspicuousness of the pouch during use. Some ostomy pouches may be provided with a drain that allows the ostomate to drain the stoma excrement from the cavity. Thereby, the ostomate can control the discharge amount in the cavity at one time, but since the ostomate needs to intermittently discharge from the pouch, the convenience is reduced.

[0006] Therefore, it would be advantageous to provide an ostomy pouch that does not suffer from the same drawbacks as the prior art in terms of inconspicuousness to the ostomate even when the volume increases.

[0007] An object of one or more embodiments of the present invention is to overcome or at least partially alleviate one or more problems associated with the prior art.

Summary of the Invention

[0008] According to one aspect of the present invention, there is provided an ostomy pouch for containing stoma excrement, the cavity including at least a first section, a second section, and a third section, a first waist section located between the first section and the second section, and a second waist section located between the second and third sections.

[0009] According to one aspect of the present invention, an ostomy pouch is provided, wherein the inner and outer walls are sealed around at least a portion of their periphery to define a cavity for accommodating stoma waste, the cavity including at least a first section, a second section, and a third section, a first waist section located between the first and second sections, and a second waist section located between the second and third sections, wherein the first and second sections have a maximum width greater than the minimum width of the first waist section, and the second and third sections have a maximum width greater than the minimum width of the second waist section.

[0010] Advantageously, the ostomy pouch of the present invention may enable ostomates to extend the duration of pouch use compared to prior art appliances. This is achieved by increasing the pouch cavity volume while maintaining the ostomate's discretion and comfort. Furthermore, the provision of a pair of waist sections inhibits (i.e., prevents or significantly reduces) pouch sagging when filled with stoma output, allowing the ostomate to accommodate a greater volume of stoma output before needing to empty or replace the pouch. This is particularly useful in cases of high stoma output. In certain embodiments, this further benefits by providing a means for reliable and hygienic drainage of the stoma output cavity, increasing ostomates' confidence in reusing pouches compared to some prior art appliances. Because ostomates may tend 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 in a given period of time may be reduced. This may also have environmental benefits, such as reducing environmental waste.

[0011] Any of the features described below may be applied to any aspect of the invention as appropriate.

[0012] The ostomy pouch may be configured to be used substantially vertically. In such an embodiment, the first section may form the upper section of the pouch. The third section may form the lower section of the pouch. The second section may form an intermediate section between the upper section and the lower section.

[0013] The ostomy pouch may be configured to be used substantially horizontally. In such an embodiment, the first section may form the first end. The third section may form the second end. The second section may form an intermediate section between the first end section and the second end section. In an embodiment, the first section forms the right side portion of the pouch. The third section may form the left side portion of the pouch. The second section may form an intermediate section between the right side portion and the left side portion.

[0014] The inner wall of the pouch may include an inlet for receiving stoma excrement into the cavity. The inlet may be provided within a portion of the inner wall that defines at least a portion of the first section of the cavity. In a presently preferred embodiment, the inlet is provided within a portion of the inner wall that defines at least a portion of the upper section of the pouch. In a further embodiment, the inlet may be provided, for example, within a portion of the second section, preferably within a portion of the inner wall that defines the intermediate section of the pouch, when used in a substantially horizontal orientation.

[0015] The pouch may be a closed pouch. In an alternative embodiment, the pouch may include an open pouch and may include a drain for releasing stoma excrement from the cavity. The drain may include a drain opening within the pouch for discharging stoma excrement from the cavity. The drain and / or the drain opening may be at least partially defined by the inner and outer walls of the pouch.

[0016] The drain may include a deployable drain that is movable between a storage position and a deployed position. The deployable drain may be movable between a storage time and a deployed position, for example, about one or more fold lines of the drain, by winding or folding the drain.

[0017] The pouch may include a fastener for holding the drain in the storage position. The fastener may be one or more fasteners. The one or more fasteners may be composed of having a pair of fastener elements. The fastener elements may include a strip of hook fastener and a strip of loop fastener that together form a hook and loop fastener configuration. The fastener elements may include two strips of hook fastener that form a double hook fastener configuration. The pouch may include a first fastener element disposed on the inner wall of the pouch. The second fastener element may be provided on the outer wall of the pouch, and in some embodiments, may be provided on the outer comfort layer of the pouch. The second fastener element may be provided on a flap and may itself be fixed (e.g., by an adhesive or other means) to the outer wall of the pouch or the outer comfort layer (if present).

[0018] The drain may be composed of one or more pursing strips. The pursing strips can be associated with the inner or outer wall of the pouch. For example, the pursing strips can be adhered or otherwise fixed to the inner or outer wall of the pouch. The pursing strips may, in part, separate the inner and outer walls of the pouch and assist in defining a drain opening in the pouch for discharging stoma excrement from the cavity.

[0019] In an embodiment, the drain is provided in a third section of the pouch. In a preferred embodiment, the drain is provided in the lower section of the pouch, for example, when the pouch is configured to be used in a substantially vertical orientation.

[0020] The pouch may include a filter arrangement. The filter arrangement can include a vent for venting gas stoma excrement from the cavity. The filter arrangement may constitute an odor filter. The odor filter can comprise, for example, a filter of charcoal or activated carbon. The odor filter may be substantially circular or disc-shaped. The major face of the circular / disc-shaped filter may be open so that gas stoma excrement can enter the filter therefrom. The odor filter can comprise, for example, a strip filter with both ends open.

[0021] The filter arrangement, or its components, such as the vent, may be provided in or associated with the outer wall of the ostomy pouch. For example, in certain embodiments, the filter arrangement may be constituted by an odor filter disposed on the outer surface of the outer wall of the pouch. In such embodiments, the vent may be an opening within the outer wall, for example, a substantially circular opening disposed in proximity to the odor filter and providing a vent through which, in use, gas stoma excrement can exit the interior of the pouch and enter the odor filter. Advantageously, by housing the odor filter inside the pouch, exposure of the filter to stoma excrement, particularly solid and liquid stoma excrement which, over a long period, can clog the filter and as a result cause the pouch to undesirably expand or balloon, can be minimized. Such a configuration is thought to be particularly useful, for example, for open pouches where the same pouch may be used by the user for an extended period.

[0022] In other embodiments, the filter arrangement may consist of an odor filter provided on the inner surface of the outer wall of the pouch. In such embodiments, the vent may be constituted by one or more slits, openings, etc. within the outer wall of the ostomy pouch. The slit may be arranged adjacent to the odor filter, for example, adjacent to the rear surface of the odor filter adhesively or otherwise coupled to the entire outside of the pouch. While suffering from the drawback that liquid and solid stoma excrement may come into contact with the odor filter for a long time, the embodiment in which the odor filter is provided inside the pouch provides a cost-effective solution and may be particularly suitable for use in a closed pouch designed for much shorter wear periods compared to, for example, an open pouch. Here, although the filter may be exposed to stoma excrement, since it is for a much shorter period, the possibility of clogging before the end of the usage period may be reduced.

[0023] The filter arrangement may have a pre-filter. The pre-filter may be configured to control the content of stoma excrement that contacts the vent and / or the odor filter. For example, the pre-filter may be advantageously configured to prevent or at least reduce the level of solid or liquid stoma excrement that can come into contact with the vent and / or the odor filter.

[0024] 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, etc. within the outer wall of the ostomy pouch. The filter arrangement may be provided within or associated with the first section of the pouch, preferably within the upper section of the pouch configured to be used in a substantially vertical orientation.

[0025] The filter arrangement may be provided with a filter cap. The filter cap may be provided, for example, on the outer surface of the outer wall of the pouch or, if present, on the outer surface of the outer comfort layer, and may be disposed around an odor filter that forms part of the filter arrangement of the pouch. The filter cap may protect the filter arrangement, and in particular may be provided for and operable to protect an odor filter in use. The filter cap may include one or more openings or slits therein, such as one or more S-shaped slits, thereby allowing gas ventilation.

[0026] The filter arrangement may further include a filter cover label. The filter cover label may be disposed on top of the filter cap during use and may be composed of a removable component capable of sealing the openings / slits therein. This is particularly effective when the ostomate plans to swim, take a bath, or shower. The label can prevent water from entering through the openings / slits of the cap, thereby preventing clogging of the odor filter by water.

[0027] The maximum widths of the first, second, and / or third sections may be equal (or substantially equal). The maximum widths of the first, second, and / or third sections may be different. For example, in some embodiments, the maximum width of the first section may be greater than the maximum widths of the second and / or third sections. The maximum width of the second section may be greater than the maximum widths of the first and / or third sections. The maximum width of the third section may be greater than the maximum widths of the first and / or second sections. In presently preferred embodiments, the maximum width of the first section is greater than the maximum width of the second section, and the maximum width of the second section is greater than the maximum width of the third section. In further embodiments, the maximum widths of the first and third sections may be greater than the maximum width of the second section. For example, the maximum widths of the first and third sections may be approximately equal and greater than the maximum width of the second section.

[0028] The maximum width of the first, second, and / or third section 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 first section may be 140 mm to 142 mm, the maximum width of the second section may be 137 mm to 139 mm, and the maximum width of the third section may be 134 mm to 136 mm.

[0029] The minimum width of the first and / or second waist section may be, for example, 105 mm to 135 mm, or 110 mm to 125 mm, or 115 mm to 130 mm, or 120 mm to 135 mm, or 115 mm to 120 mm, or 120 mm to 125 mm, or 125 mm to 130 mm, or about 120 mm. In an exemplary embodiment, the minimum width of the first and / or second waist section may be about 129 mm, or 119 mm, or 109 mm.

[0030] It is desirable that the minimum width of the first waist section is 5 mm or more and 30 mm or less, or 10 mm or more and 20 mm or less, or 15 mm or more and 20 mm or less than the maximum width of the second section. The minimum width of the waist portion may be, for example, 10 mm to 35 mm smaller than the maximum width of the first section, 15 mm to 30 mm smaller than the maximum width of the first section, or 20 mm to 25 mm smaller than the maximum width of the first section.

[0031] The minimum width of the first waist section may be 75% or more and 95% or less, or 80% or more and 90% or less, or 83% or more and 88% or less of the maximum width of the second section. The minimum width of the first waist section may be 73% or more and 92% or less, or 75% or more and 85% or less, or 80% or more and 85% or less of the maximum width of the first section.

[0032] The minimum width of the second waist section may be smaller than the maximum width of the third section by 5 mm or more and 30 mm or less, or may be smaller by 10 mm or more and 20 mm or less, or may be smaller by 15 mm or more and 20 mm or less. The minimum width of the waist portion may be, for example, 10 mm to 35 mm smaller than the maximum width of the second section, may be 15 mm to 30 mm smaller than the maximum width of the second section, or may be 20 mm to 25 mm smaller than the maximum width of the second section.

[0033] The minimum width of the second waist section may be 75% or more and 95% or less of the maximum width of the third section, or may be 80% or more and 90% or less of the maximum width of the third section, or may be 83% or more and 88% or less of the maximum width of the third section. The minimum width of the second waist section may also be 73% or more and 92% or less of the maximum width of the second section, may be 75% or more and 85% or less of the maximum width of the second section, or may be 80% or more and 85% or less of the maximum width of the second section.

[0034] In an embodiment where the pouch is a closed pouch, the pouch may have a length of, for example, 150 mm to 350 mm, or 200 mm to 300 mm, or 200 mm to 250 mm, or 205 mm to 235 mm, or 208 mm to 230 mm. In an embodiment where the pouch is an open pouch, the pouch may have a length between, for example, 200 mm to 400 mm, or between 225 mm to 350 mm, or between 250 mm to 300 mm, or between 260 mm to 290 mm, or between 270 mm to 280 mm. In an embodiment where the pouch consists of a deployable drain, the length when the deployable drain is in the deployed position may be 240 mm to 350 mm, and the length when the deployable drain is in the stored position may be 200 mm to 240 mm.

[0035] The opposing edges of the first and / or second waist sections may each be curved concavely. The opposing edges of the first and / or second waist sections may each have a radius of curvature, or a mixture of radii of curvature, and 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 about 40 mm. The opposing edges of the first and / or second waist sections may be configured in substantially the same manner or form, for example, being mirror images of each other.

[0036] The first, second, or third section may be generally rounded in shape. For example, the first section may have a continuously curved edge extending from the first edge (e.g., the left end) of the first waist section to the second edge (e.g., the right end) of the second waist section. The second section may have a first continuously curved edge extending from the first edge (e.g., the left end) of the second waist section to the first edge (e.g., the left end) of the first waist section. The second section may have a second continuously curved edge extending from the second edge (e.g., the right end) of the second waist section to the second edge (e.g., the right end) of the first waist section. The third section may have a continuously curved edge extending from the first edge (e.g., the left end) of the second waist section to the second edge (e.g., the right end) of the second waist section.

[0037] The continuously curved ends of the first, second, and / or third sections may be convexly curved. The continuously curved ends of the first, second, and / or third sections may have no inflection points or abrupt contour changes. The continuously curved ends of the first, second, and / or third sections may have a radius of curvature, or a combination of radii of curvature, and each radius of curvature may be, for example, from 40 mm to 80 mm, or from 55 mm to 75 mm, or from 60 mm to 73 mm, or from 65 mm to 70 mm. The curvature or each radius of the first, second, and third sections may be substantially equal. In an embodiment, the curvature or each radius of the second section may be greater than the curvature or each radius of the first and / or third sections.

[0038] In other embodiments, one or more of the first, second, and / or third sections may be one or more edges that form or constitute a substantially straight one. For example, the second section may be composed of a first substantially straight edge extending from the first edge (e.g., the left end) of the first waist section to the first edge (e.g., the left end) of the second waist section. The second section may be composed of a second substantially straight edge extending from the second edge (e.g., the right end) of the first waist section to the second edge (e.g., the right end) of the second waist section. In such embodiments, the first and / or third sections may have an overall rounded shape in the manner described herein.

[0039] The branch points of the first or second section and the first waist section can be demarcated by an inflection point at a single point between the left end of the first or second section and the left end of the first waist section, and an inflection point at a single point between the right end of the first or second section and the right end of the first waist section. The branch points of the second or third section and the second waist section can be defined by an inflection point at a single point between the left end of the second or third section and the left end of the second waist section, and an inflection point at a single point between the right end of the second or third section and the right end of the second waist section.

[0040] The position of the minimum width of the first waist section may be at a distance of 90 mm to 125 mm, or 95 mm to 120 mm, or 100 mm to 115 mm, or 105 mm to 115 mm, or about 99 mm, 109 mm, 119 mm from the upper end of the stoma pouch. The position of the minimum width of the second waist section may be at a distance of 90 mm or more and 125 mm or less, or 95 mm or more and 120 mm or less, or 100 mm or more and 115 mm or less from the lowermost end of the stoma pouch. The distance between the position of the minimum width of the first waist section and the upper edge of the stoma pouch, and / or the distance between the position of the minimum width of the second waist section and the lower edge of the stoma pouch may be, for example, 20 to 45% of the length of the pouch, or 25 to 40% of the length of the stoma pouch, or 30 to 35% of the length of the stoma pouch.

[0041] The inner wall and the outer wall may be joined by one continuous edge seal. For example, when the pouch is a closed pouch, one continuous edge seal can form a closed peripheral seal. When the stoma pouch is an open pouch, one continuous edge seal may be in the range from the first edge (e.g., the left end) of the drainage port to the second edge (e.g., the right end) of the drainage port of the pouch. One continuous edge seal may constitute a welded part, and this joint may optionally have a width of, for example, 2 mm to 6 mm, or 3 mm to 5 mm, or about 4 mm. One continuous edge seal may have a constant width around the periphery of the stoma pouch.

[0042] The inner wall and the outer wall may be formed from a flexible sheet material. The flexible sheet material may be a single layer or a multi-layer laminate. The flexible sheet material of the inner wall and / or the outer wall may be made of polyvinylidene chloride (PVDC) and / or ethylene vinyl acetate (EVA). The inner wall and / or the outer wall may have a thickness of, for example, 50 to 150 μm, or 75 to 125 μm, or 75 to 100 μm.

[0043] The pouch may further comprise at least one comfort layer overlying at least a portion of one of the inner and outer walls. The pouch may comprise an inner comfort layer and / or an outer comfort layer.

[0044] If present, the outer comfort layer may comprise a first section and a second section and may be joined to the outer wall such that the first section overlaps the second section at an overlap region. The first and second sections 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 during use of the pouch. The first and second sections 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 sections may be joined to each other at first and second ends of the overlap region. The first and second sections may be welded to each other at the first and second ends of the overlap region, optionally as part of a peripheral 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.

[0045] 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. However, it is preferred that the inner comfort layer cover 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 connection of the inlet in the inner wall to the Ostomy wafer.

[0046] At least one comfort layer may be formed from a flexible sheet material. The material of the flexible sheet material may be composed of one or more of polyester, nylon, viscose, polyurethane, polyethylene, polypropylene, polyvinylidene chloride (PVDC), and ethylene vinyl acetate (EVA). At least one comfort layer may include a laminate of two or more layers. At least one comfort layer can include at least one fabric layer and at least one film layer. At least one film layer may be laminated to at least one fabric layer, and optionally, may be laminated to at least one fabric layer over the entire area of at least one comfort layer. At least one fabric layer may include a woven or non-woven layer. The fabric layer can include polyester, nylon, viscose, polyethylene, or polypropylene. At least one film layer may include polyurethane, polyvinylidene chloride (PVDC), or ethylene vinyl acetate (EVA). At least one comfort layer can have a thickness, for example, between 50 and 1000 micrometers, or between 60 and 500 micrometers, or between 75 and 300 micrometers, or between 100 and 200 micrometers.

[0047] The inner wall and the inner comfort layer may be joined at their peripheries, and / or the outer wall and the outer comfort layer may be joined at their peripheries. Joining can be done using welding, adhesives, or equivalent means. In one bonding operation, the inner comfort layer, the inner wall, the outer wall, and the outer comfort layer can be joined. For example, a single weld can be used to join the four layers.

[0048] 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 partitions, wall members, or filter elements. In some embodiments, the pouch includes a septum between an inner wall and an outer wall that defines the cavity into a first and a second chamber. The septum may have a filtering element. The filtering element may be fluid permeable and may be operable to filter fluidic stoma excrement from solid stoma excrement.

[0049] The filtering element may include an array of openings that allow fluidic stoma excrement to pass therethrough. The openings may have a diameter 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, from 0.80 mm to 2.20 mm, or from 1.00 mm to 2.00 mm, or from 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.

[0050] In use, the first chamber of the cavity is arranged to receive both liquid and solid stoma excrement from the ostomate through an inlet in the inner wall. The septum is arranged to allow the liquid stoma excrement to pass through to the second chamber while retaining the solid stoma excrement in the first chamber. In embodiments where the pouch consists of a filter arrangement, the filter arrangement is further used to separate the gaseous stoma emissions from the fluidic stoma excrement and can allow the gaseous stoma emissions to be removed from the cavity.

[0051] The pouch can include either an ostomy wafer disposed within or otherwise associated with the inlet of the inner wall, or a releasable coupling disposed within or otherwise associated with the inlet of the inner wall. In an embodiment, the releasable coupling may be configured to couple with a body fitting component that makes up the ostomy wafer. If present, the ostomy wafer can extend through an opening in the inner wall and / or the inner comfort layer. The ostomy wafer may include a peelable liner that the user can remove prior to securing the pouch to the ostomate during use.

[0052] The pouch may consist of only three sections. Alternatively, the pouch includes at least three sections. The pouch may have one or more additional sections, such as a fourth section and / or a fifth section. One or more additional sections may be separated from one or more other sections of the pouch by respective waist sections. The waist section may have a minimum width that is less than the maximum width of the additional section.

[0053] According to one aspect of the present invention, a method for collecting stoma excrement using an ostomy pouch according to any of the aspects described herein is provided. The method may include attaching the ostomy pouch to the stoma of the ostomate. The ostomy pouch can be attached to the stoma using the ostomy wafer of the pouch if the pouch is a one-piece ostomy pouch. Alternatively, the method may include attaching the ostomy wafer of the body fitting component of a two-piece ostomy pouch around the stoma, and may include attaching the pouch to the body fitting component. The pouch may be attached to the body fitting component before or after the ostomy wafer is attached around the stoma. If the ostomy pouch is an open or drainable pouch, the method can include draining stoma excrement from the ostomy pouch. Detailed Description of the Invention

[0054] To understand the present invention more clearly, one or more embodiments thereof will now be described by way of example only with reference to the accompanying drawings.

Brief Description of the Drawings

[0055]

Figure 1A

Figure 1B

Figure 1C

Figure 2A

Figure 2B

Figure 3A

Figure 3B

Figure 4

Figure 5

Figure 6

[0056] As used herein and throughout this specification, the term "stoma excrement" refers to any gas, liquid or solid that can be secreted from the stoma or that exits from the stoma of an ostomate, generated by the ostomate. The stoma excrement may consist of gaseous, fluid, liquid and / or solid stoma excrement.

[0057] The term "stoma" refers to an opening in the body. Generally, a stoma is a surgical opening in the torso. In some cases, the term "stoma" also refers to the internal tissue, organ, or a part thereof that is exposed by the opening. As a non-limiting example, the internal tissue can be selected from the colon, ileum, small intestine, large intestine, jejunum, and duodenum, as well as combinations thereof. The internal tissue can be the end or loop of the small intestine or large intestine.

[0058] The term "ostomate" refers to a subject who may utilize the ostomy pouch described herein. An ostomate typically refers to a subject having a surgical opening, but as used herein, "ostomate" may refer to a subject having a stoma regardless of whether the stoma was created by surgery or other means.

[0059] The term "user" may refer to an ostomate or, for example, another person who assists the ostomate when emptying stoma excrement from a cavity.

[0060] The ostomy pouch disclosed herein may be used for the management of stomas created by, for example, esophagostomy, gastrostomy, cholecystostomy, choledochostomy, colostomy, colectomy, duodenostomy, ileostomy, jejunostomy, appendicostomy, tracheostomy, urostomy, nephrostomy, ureterostomy, or cystostomy. The ostomy pouch disclosed herein may be used in conjunction with additional devices including, but not limited to, shunts, catheters, plugs, or fecal management systems.

[0061] In this specification, the position and orientation of features may be described in terms of the ostomy pouch being "in use" or "oriented as it would be in use". Such terms refer to the intended orientation of the ostomy pouch when the ostomy appliance is adhered or otherwise secured to the body of the ostomate, regardless of whether the ostomy pouch is currently being used in such a manner or the actual position of the ostomate, for example, when the ostomate is standing. The terms "upper" and "lower", and related terms, refer to the relative position when a part or parts of the ostomy pouch are oriented as if 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, the section is intended to be the uppermost (in the vertical direction) part of the ostomy pouch when worn on the body of a standing ostomate. However, those skilled in the art will understand that before attachment to the ostomate, the section is not always the uppermost, and further, when the ostomate assumes a non-standing position, such as a recumbent position, during attachment, the section is not always the uppermost.

[0062] The terms "left side" and "right side", and related terms, may refer to the case when the ostomy pouch is viewed from the rear (for example, as shown in Figure 1A). Thus, by way of example, in a situation where the ostomy pouch is attached to the front torso of the ostomate, the "left side" edge of the ostomy appliance will be directed towards the left side of the ostomate.

[0063] The terms "concave" and "convex", and related terms, refer to the shape of the features of the ostomy pouch when viewed from the outside of the ostomy pouch. Thus, by way of example, a circular ostomy wafer is considered to have a convex peripheral edge.

[0064] The terms "inner" and "outer" refer to the relative position of a portion or part of the ostomy pouch with respect to the ostomate's body when the ostomy pouch is attached (e.g., by an adhesive or other means) to the ostomate's body. "Inner" refers to a position relatively closer to the body than the "outer" of the ostomate. "Outer" refers to a position relatively farther from the ostomate's body than the comparative position that is "inner".

[0065] The ostomy pouch is generally attached to the ostomate's body by an ostomy wafer that includes one or more adhesive layers. The ostomy wafer typically includes an opening for the stoma, called a starter hole, and may be cut to the required size by the user prior to attachment. The ostomy wafer typically includes an adhesive layer on the side facing the body for adhering the ostomy wafer to the ostomate's body. Usually, a release liner covers the side of the ostomy wafer facing the body and is removed by the user prior to application to the skin. As used herein, the term "ostomy wafer" may be used interchangeably with the terms "adapter", "wafer", "baseplate", or "laminated adhesive wafer". An "ostomy wafer", "adapter", "wafer", "baseplate", or "laminated adhesive wafer" can form a skin barrier between the ostomate and the pouch. As used herein, the term "ostomy wafer" includes ostomy wafers for "two-piece appliances" and "one-piece appliances".

[0066] The "two-piece pouch" refers to an ostomy pouch in which the stoma wafer forms part of another body-fitting component attached to the pouch by a removable connection. The two-piece pouch allows the body-fitting component to be separated from the pouch without damaging it, so at least one of the parts can continue to be used functionally. For example, the body-fitting component may remain attached to the body of the ostomate. In contrast, the "one-piece pouch" refers to an ostomy pouch in which the stoma wafer is permanently attached to the appliance, and the stoma wafer cannot be easily separated without risking damage to the appliance. The one-piece pouch is intended to be used as an integrated unit.

[0067] Ostomy pouches may generally be configured as "closed" pouches or "open" pouches. As used herein, a "closed pouch" refers to an ostomy pouch in which stoma effluent is not intended to flow out of the cavity. Thus, a closed pouch may typically be configured as a single-use, disposable, non-reusable pouch. As used herein, an "open pouch" refers to an ostomy pouch that allows stoma effluent to be drained from the cavity and the pouch to be reused. Thus, an open pouch, although not essential, can be configured as a reusable pouch so that it can be reused multiple times and emptied while attached to the body. In an open pouch, stoma effluent may be drained intermittently, induced by the actions of the ostomate, or may be drained intermittently or continuously because the cavity is fluidly connected to a drain pipe, such as a night drainage line.

[0068] The use of a closed pouch or an open pouch depends on user preference, but depending on the needs of a particular ostomate and the location of the ostomate's stoma, one or the other may be more suitable. For example, in the case of a stoma formed by ileostomy, the stoma excrement is more loose and tends to be easier to discharge, so an open pouch may be suitable. In the case of a stoma formed by an artificial anus, the stoma excrement tends to solidify and the user may not be able to discharge it easily. In such cases, a closed pouch may sometimes be more suitable.

[0069] Conditional language such as "can", "could", "might", or "may", unless otherwise specified or understood within the context in which it is used, is generally not intended to convey that a particular embodiment includes a particular feature, element, and / or step and that other embodiments do not. Thus, such conditional language is generally not intended to mean that a feature, element, and / or step is required in any way in one or more embodiments, or that one or more embodiments necessarily include logic for determining whether these features, elements, and / or steps are included in, or performed in, any particular embodiment in response to user input or prompting.

[0070] The figures illustrate a series of embodiments of the present invention. Where equivalent components exist between embodiments, like reference numerals are used.

[0071] Generally, the present invention relates to an ostomy pouch 10, 110 defined by inner walls 18b, 118b and outer walls 20b, 120b that are sealed at least in part around their perimeter and having a cavity for containing stoma excrement.

[0072] Figures 1A - 1C are diagrams showing a first embodiment of the ostomy pouch 10 of the present invention.

[0073] The pouch 10 consists of an inner wall 18b and an outer wall 20b sealed around its perimeter, defining a cavity for accommodating stoma excrement. The pouch 10 is a closed pouch, and a seal is provided as a single continuous seal around the entire perimeter of the pouch 10. The cavity includes a first section 12, a second section 14, and a third section 16 that are generally rounded in shape with a convex curved surface, defining an upper section, a lower section 12, 16, and an intermediate section 14 located between the upper and lower sections 12, 16. The upper section, middle section, and lower section 12, 14, 16 are separated by waist sections 13, 15 that are narrower than the upper section, middle section, and lower section 12, 14, 16. Specifically, the pouch 10 includes a first waist section 13 located between the upper section 12 and the intermediate section 14, and the maximum widths of the upper section 12 and the intermediate section 14 are greater than the minimum width of the first waist section 13. Further, the pouch 10 includes a second waist section 15 located between the intermediate section 14 and the lower section 16, and the maximum widths of the intermediate section 14 and the lower section 16 are greater than the minimum width of the second waist section 15.

[0074] The inner wall and outer wall 18b, 20b are formed of a flexible plastic sheet material. The pouch 10 also includes inner and outer comfort layers 18a, 20a that overlap the respective inner wall and outer wall 18b, 20b. The comfort layers 18a, 20a are formed of a woven fabric or cloth material and define the outer surface of the pouch 10. In the illustrated embodiment, the inner comfort layer 18a, the inner wall 18b, the outer wall 20b, and the outer comfort layer 20a are joined together here by welding at one time.

[0075] The inner wall 18b includes an opening therein that defines a stoma inlet 48 within the pouch 10 for receiving stoma excrement into the cavity. Here, the stoma inlet 48 is provided within the upper section 12 of the pouch 10. An ostomy wafer 24 is disposed on the inner comfort layer 18a, and an opening 46 is provided that defines a wafer opening disposed above the stoma inlet 48 during use.

[0076] 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 an ostomate's stoma during use. The release liner 25 is provided with a tab 26 to assist a user in removing the release liner 25. The ostomy wafer 24 is preferably further secured to the interior wall 18b, such as by using the 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 according to 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 another configuration, the adhesive region can be configured to fit a stoma, for example, by a user cutting the region to form the central opening 22 to the desired size and shape.

[0077] 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 compartments. The separation filter 50 is fluid-permeable and operable to filter fluid (i.e., gases and liquids) 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 contain both liquids and solids. 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 to the inner and outer walls 18b, 20b.

[0078] To vent the gas stoma discharge from the cavity, another filter arrangement 30 is provided within the outer wall 20b. Thereby, advantageously, the capacity of the pouch 10 for receiving liquid and solid stoma excreta can be advantageously maximized, preventing the "swelling" or "ballooning" of the pouch 10 that may adversely affect the inconspicuousness during use of the pouch 10. The filter arrangement 30 is provided within the upper section 12 of the pouch.

[0079] The filter arrangement 30 includes a vent and an odor filter (such as a charcoal or activated carbon filter) for reducing the release of unpleasant odors from the cavity. The outer comfort layer 20a close to the position of the filter arrangement 30 is provided with a slit 52, such that the gas stoma excreta passing through the filter arrangement 30 is discharged from the pouch 10. The separation filter 50 preferably prevents solid stoma excreta from contacting the filter arrangement 30, thereby preventing or reducing the possibility that the filter arrangement 30 becomes clogged and the cavity cannot be sufficiently ventilated.

[0080] Figures 2A - 4 show a second embodiment of the pouch 110 according to the present invention.

[0081] When the features of the pouch 110 are equivalent to those of the pouch 10, the same reference numerals are used. The functions equivalent to those of the pouch 10 described herein are configured in the same manner in the pouch 110 unless otherwise specified herein. For common features, refer also to the previous description.

[0082] The pouch 110 is formed by an inner wall 118b and an outer wall 120b, with their peripheries sealed therearound, defining a cavity for accommodating stoma excrement. Here too, the cavity includes a first section 112 having an overall rounded shape with a convex curved surface, a second section 114, and a third section 116 defining an upper section 112, a lower section 116, and an intermediate section 114 located between the upper and lower sections 112, 116. The upper, intermediate, and lower sections 112, 114, 116 are delimited by waist sections 113, 115 that are narrower than the upper, intermediate, and lower sections 112, 114, 116. Specifically, the pouch 110 includes a first waist section 113 located between the upper section 112 and the intermediate section 114, and the maximum widths of the upper section 112 and the intermediate section 114 are greater than the minimum width of the first waist section 113. Further, the pouch 110 includes a second waist section 115 located between the intermediate section 114 and the lower section 116, and the maximum widths of the intermediate section 114 and the lower section 116 are greater than the minimum width of the second waist section 115.

[0083] Similar to the pouch 10, the inner and outer walls 118b, 120b are formed of a flexible plastic sheet material, a woven or fabric material, and include inner and outer comfort layers 118a, 120a that overlap the respective inner and outer walls 118b, 120b. Also in this case, a stoma inlet 148 for receiving stoma excrement into the cavity is provided in the upper section 112 of the pouch 110, and the ostomy wafer 124 is positioned within the opening 146 of the inner comfort layer 118a so as to be positioned above the stoma inlet 148 during use. The ostomy wafer 124 is configured as the ostomy wafer 24 described herein in the same manner. The pouch similarly includes a separation filter 150 and a filter arrangement 130 configured substantially in the same manner as the separation filter 50 and the filter arrangement 30 of the pouch 10.

[0084] The pouch 110 is different in that it is an "open" pouch 110 that includes a drain 132 for discharging stoma excrement from the cavity.

[0085] The drain 132 is formed in the lower section 116 of the pouch 110 and constitutes a drain opening 135 that includes an unsealed portion around the pouch 110, that is, an area that is not sealed to each other among the areas around the inner wall and the outer walls 118b, 120b. Stoma excrement may be released from the cavity through the drain opening 135 during use.

[0086] In the illustrated embodiment, the drain 132 is integral with the inner and outer walls 118b, 120b and forms an elongated portion of the pouch 110 that extends downward from the lower edge of the lower section 116. The inner and outer comfort layers 118a, 120a are not provided on the drain 132. Similarly, the separation filter 150 is aligned with the inner and outer comfort layers 118a, 120a and does not extend into the drain 132. Here, the separation filter 150 is not sealed to the inner wall and the outer walls 118b, 120b at its lowermost end, so that stoma excrement can be drained through the drain 132 from both the first chamber and the second chamber of the cavity.

[0087] In the illustrated embodiment, the drain 132 is a deployable drain 132 that is movable between a deployed position (shown in FIGS. 2A and 2B) and a stowed position (shown in FIGS. 3A and 3B). Moving the drain 132 to the stowed position effectively closes the drain opening 135 and prevents stoma excrement from being released from the cavity. Specifically, the drain 132 is foldable between the deployed state and the stowed position about fold lines 137, 139 provided on the drain 13). The fold lines define the drain 132 into first and second segments 134, 136, and the segments 134, 136 can be folded on top of each other around the fold lines 137, 139 when moving, for example, from the deployed position to the stowed position.

[0088] The parsing strips 138a, 138b are provided on opposite sides of the first segment 134 of the drain 132, specifically, on portions of the inner and outer walls 118b, 120b that define the first segment 134 of the drain 132, locally stiffen the drain 132, and assist in opening the drain outlet 135 during use. Specifically, the parsing strips 138a, 138b can be laterally constricted to arch the parsing strips 138a, 138b (and the inner and outer walls 118b, 120b respectively) in an opposing direction to open the drain outlet 135.

[0089] The drain 132 includes a first fastener element in the form of a strip-shaped hook fastener 140 provided on the outer surface of the inner wall 118b. Specifically, the strip of the hook fastener 140 is provided on the outer surface of the portion of the inner wall 118b that defines the second segment 136 of the drain 132. The corresponding second fastener element 142 is provided on a flap 144 attached (e.g., adhesively fixed) to the outer surface of the outer comfort layer 120a. The second fastener element also takes the form of a strip of hook fastener 142.

[0090] During use, as shown in FIG. 3B, the first segment 134 is folded along the fold line 137 to be adjacent to and overlie the second segment, and then the second segment 136 is folded about the fold line 139 so that the folded drain 132 is adjacent to and overlies a portion of the outer comfort layer 120a, away from the ostomy, and the drain 132 is folded upward about the fold lines 137, 139 to move the drain 132 from the deployed position to the storage position. Thereafter, the flap 144 is folded downward to bring the second fastener element 142 into contact and engagement with the first fastener element 140 to hold the drain 132 in the storage position. The drain 132 can be moved from the storage position to the deployed position in the reverse procedure.

[0091] FIG. 5 shows a third embodiment of the pouch 210 according to the present invention. When the features of the pouch 210 are equivalent to those of the pouches 10 and 110, the same reference numerals are used. Unless otherwise specified herein, equivalent features are configured in the pouch 210 in the same manner as the pouches 10 and 110 described herein. For common features, refer also to the previous description.

[0092] The pouch 210 differs in that it is configured to be used in a horizontal orientation. Here, the inner and outer walls are sealed around their peripheries and divided into a left side portion 212, a right side portion 216, and an intermediate section 214, defining a closed cavity separated by waist sections 213 and 215 that are narrower than the left, middle, and right side portions 212, 214, 216. The pouch 210 is otherwise configured in the same manner as the pouch 10 described herein, and the left side face 212 is specifically configured in the same manner as the upper section 12.

[0093] FIG. 6 shows a fourth embodiment of the pouch 310 according to the present invention. When the features of the pouch 310 are equivalent to those of the pouches 10, 110, and 210, the same reference numerals are used. Unless otherwise specified herein, equivalent features are configured in the pouch 310 in the same manner as the pouches 10, 110, and 210 described herein. For common features, refer also to the previous description.

[0094] The pouch 310 is also configured to be used in a horizontal orientation. Here, the inner and outer walls are sealed around their peripheries and divided into a left side portion 312, a right side portion 316, and an intermediate section 314, defining an open cavity separated by waist sections 313 and 315 that are narrower than the left, middle, and right side portions 312, 314, 316. The pouch 310 is otherwise configured in the same manner as the pouch 110 described herein, with the left side face 312 specifically configured in the same manner as the upper section 112, the right side face 316 configured in substantially the same manner as the lower section 216, and a drain 332 provided at its lowermost end.

[0095] One or more embodiments are described above only by way of example. Many variations are possible without departing from the scope of protection set out in the appended claims.

Claims

1. Defined by an inner wall and an outer wall sealed at least partially around its perimeter, and having a cavity for containing stoma excrement, Said cavity is, A first section, a second section, and a third section, A first waist section between said first section and said second section, A second waist section between said second section and said third section, at least including, Said first and second sections have a maximum width greater than the minimum width of said first waist section, and said second and third sections have a maximum width greater than the minimum width of said second waist section, an ostomy pouch.

2. Said pouch is configured to be used substantially vertically, said first section forms the upper section of said pouch, said third section forms the lower section of said pouch, and said second section forms an intermediate section between said upper section and said lower section, the ostomy pouch according to claim 1.

3. Said pouch is configured to be used substantially horizontally, said first section forms a first end, said third section forms a second end, and said second section forms an intermediate section between said first and second ends, the ostomy pouch according to claim 1.

4. Said first section forms the right side portion of said pouch, and said third section forms the left side portion of said pouch, the ostomy pouch according to claim 3.

5. Said inner wall of said pouch is provided with an inlet for receiving said stoma excrement into said cavity, the ostomy pouch according to any one of claims 1 to 4.

6. Said inlet is provided in a part of said inner wall that defines at least a part of said first section of said cavity, the ostomy pouch according to claim 5.

7. Said inlet is provided in a part of said inner wall that defines at least a part of said second section of said pouch, the ostomy pouch according to claim 5.

8. An ostomy pouch having an open pouch including a drain for discharging stoma excrement from the cavity, the drain including a drain outlet having an opening within the pouch for discharging stoma excrement from the cavity, according to any one of claims 1 to 7.

9. The ostomy pouch according to claim 8, wherein the drain includes a deployable drain movable between a storage position and a deployed position.

10. The ostomy pouch according to claim 8 or claim 9, wherein the drain is provided in the third section of the pouch.

11. An ostomy pouch according to any one of claims 1 to 10, having a filter arrangement including a vent for venting gas from the stoma excrement from the cavity, and an optional odor filter.

12. The ostomy pouch according to claim 11, wherein the filter arrangement comprises a prefilter configured to control the contents of the stoma excrement in contact with the vent and / or the odor filter.

13. The ostomy pouch according to claim 11, wherein the filter arrangement is provided within or associated with the first section of the pouch.

14. The ostomy pouch according to any one of claims 1 to 13, wherein the maximum widths of the first, second and / or third sections are substantially equal.

15. The ostomy pouch according to any one of claims 1 to 13, wherein the maximum widths of the first, second and / or third sections are different.

16. The ostomy pouch according to claim 15, wherein the maximum width of the first section is greater than the maximum width of the second section, and the maximum width of the second section is greater than the maximum width of the third section.

17. The ostomy pouch according to any one of claims 1 to 16, wherein the opposing edges of the first and / or second waist sections are each curved concave.

18. The ostomy pouch according to any one of claims 1 to 17, wherein the first, second and / or third sections are generally rounded in shape and have at least one continuously curved edge.

19. The ostomy pouch according to claim 18, wherein the continuously curved edge of the first, second and / or third section is curved convexly. **Claim 20** The ostomy pouch according to any one of claims 1 to 19, wherein the cavity is divided into two or more chambers. **Claim 21** The ostomy pouch according to claim 20, comprising a partition between the inner wall and the outer wall that defines the cavity into a first and a second chamber, the partition having a fluid permeable filter element operable to filter fluid ostomy excrement from solid ostomy excrement.

Images