Ostomy Pouch
20210369493 · 2021-12-02
Inventors
Cpc classification
International classification
Abstract
The invention relates to an ostomy pouch 10. The pouch 10 includes inner and outer walls 18b, 20b of flexible sheet material which sealed about a periphery. The walls 18b, 20b define a cavity for containing a stomal output and a drain 32 for draining stomal output from the cavity. An opaque comfort layer 18a, 20a is provided, at over an outer surface of the inner and/or outer walls 18b, 20b. The drain 32 is moveable between a deployed position for draining the stomal output from the cavity and a stowed position for storage of the drain 32, with at least part of the drain 32 overlying a portion of the comfort layer 18a, 20a in the stowed position. The drain 32 is substantially opaque on one side, and at least partly transparent on an opposing side.
Claims
1. An ostomy pouch, comprising: inner and outer walls of flexible sheet material sealed about a periphery thereof to define: a cavity for containing a stomal output; and a deployable drain for draining stomal output from the cavity; a substantially opaque comfort layer provided, at least in part over an outer surface of the inner and/or outer walls of the flexible sheet material; and a fastener arrangement configured to retain the deployable drain in the stowed position, the fastener arrangement comprising a first fastener located on an outer surface of the comfort material and a second fastener provided on the inner wall or outer wall of the ostomy pouch; wherein the deployable drain is moveable between a deployed position for draining the stomal output from the cavity and a stowed position for storage of the deployable drain, with at least part of the drain overlying a portion of the comfort layer in the stowed position; and wherein 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 partly transparent.
2. An ostomy pouch of claim 1, wherein the drain comprises an elongate extension of the inner and outer walls, extending from a drain inlet at the cavity and a drain aperture at a distal end of the drain channel through which stomal output from within the cavity can be drained from the pouch.
3. An ostomy pouch as claimed in claim 1, wherein the deployable drain is moveable between stowed and deployed positions by rolling or folding the drain and wherein the drain is moveable, in use, from the deployed position to the stowed position by folding and/or rolling the drain in a direction which is upwards and away from the ostomate.
4. (canceled)
5. An ostomy pouch as claimed in claim 1, wherein the second fastener is located on a portion of the inner wall of the pouch at least partly defining the drain.
6. An ostomy pouch as claimed in claim 1, wherein the first fastener comprises a flap, which is secured to the comfort layer.
7. An ostomy pouch as claimed in claim 6, wherein the flap is provided on a comfort layer overlying an outer wall of the pouch, away from the ostomate, in use.
8. (canceled)
9. An ostomy pouch as claimed in claim 6, wherein the pouch comprises one or more curved edges, and the flap is similarly curved to correspond the contours of the curved edge(s) of the pouch.
10. An ostomy pouch as claimed in claim 6, wherein the flap extends across at least substantially the entire width of the pouch.
11. An ostomy pouch as claimed in claim 1, wherein the drain comprises a pair of pursing strips, each strip being adhesively or otherwise fixed to the inner or outer wall of the pouch.
12. An ostomy pouch as claimed in claim 1, wherein the drain is sub-divided into two or more segments defined by fold lines about which the drain may be folded when moving between deployed and stowed positions, wherein the drain segments are sequentially folded to overlie one another in moving from the deployed position to the stowed position.
13. (canceled)
14. An ostomy pouch as claimed in claim 12, wherein the drain is sub-divided into three segments, with a first pursing strip positioned on the inner wall of the pouch and defining, at least in part a first segment of the drain, a second pursing strip positioned on the outer wall of the pouch and defining, at least in part a second segment of the drain, and with the second fastener provided on the inner wall of the pouch and defining, at least in part, a third segment of the drain.
15. An ostomy pouch as claimed in claim 1, wherein at least a portion of the deployable drain is visible in the stowed position.
16. An ostomy pouch as claimed in claim 6, wherein at least a portion of the deployable drain is visible in the stowed position and wherein in the stowed position the deployable drain is partly covered by the flap, but also has one or more portions which remain uncovered and thereby visible, in use.
17. An ostomy pouch as claimed in claim 16, wherein the or each portion visible in the stowed position comprises a region or regions of the drain at or proximal to one or more edges.
18. An ostomy pouch as claimed in claim 17, wherein the or each portion visible in the stowed position comprises a portion of the opaque inner wall of the pouch defining the drain.
19. (canceled)
20. An ostomy pouch as claimed in claim 1, wherein the pouch comprises an inner comfort layer and an outer comfort layer, the inner comfort layer overlying at least a portion of the inner wall of the pouch and the outer comfort layer overlying at least a portion of the outer wall of the pouch.
21. An ostomy pouch as claimed in claim 20, wherein the comfort layer(s) do not overlie the inner or outer walls of the pouch at the portions of the inner and/or outer walls which define the drain.
22. An ostomy pouch as claimed in claim 1, wherein the cavity comprises an upper section, a lower section, and a waisted section located between the upper and lower sections, wherein the waisted section comprises a minimum width which is less than the maximum width of the upper and/or lower sections.
23. An ostomy pouch according to claim 12 wherein the flap extends up to the seal about the periphery of the pouch.
24. An ostomy pouch according to claim 12 wherein the flap extends across the entire width of the pouch, right to the edge of the pouch.
Description
DETAILED DESCRIPTION OF THE INVENTION
[0061] In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which:
[0062]
[0063]
[0064]
[0065]
[0066]
[0067]
[0068]
[0069]
[0070]
[0071]
[0072] When used herein and throughout the specification, the term “stomal output” refers to any gases, liquids or solids produced by an ostomate that may be secreted from a stoma or that exit a stoma of the ostomate. The stomal output may comprise gaseous, fluid, liquid and/or solid stomal output.
[0073] The term “stoma” refers to an opening in the body. Generally the stoma is a surgical opening in the torso of the body. In some instances, the term “stoma” also refers to internal tissue, organs or portions thereof that are exposed by the opening. By way of non-limiting example, internal tissue may be selected from colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be an end or a loop of a small or large intestine.
[0074] The term “ostomate” refers to a subject that may have use of the ostomy pouch described herein. While ostomate usually refers to a subject with a surgical opening, as used herein, “ostomate” may refer to a subject who has a stoma, regardless of whether the stoma was created by surgery or other means.
[0075] The term “user” may refer to an ostomate, or to another person assisting the ostomate, for example, with emptying of the stomal output from the cavity.
[0076] Ostomy pouches disclosed herein may, for example, be used for managing a stoma created by an esophagostomy, a gastrostomy, a cholecystostomy, a choledochostomy, a cecostomy, a colostomy, a duodenostomy, an ileostomy, a jejunostomy, an appendicostomy, a tracheostomy, a urostomy, a nephrostomy, a ureterostomy, or a vesicostomy. The ostomy pouches disclosed herein may be used with additional devices including, but not limited to, a shunt, a catheter, a plug or a faecal management system.
[0077] In this specification locations and orientations of features may be described with reference to the ostomy pouch being “in use”, “orientated as it would be in use” or similar. Such terms refer to the intended orientation of the ostomy pouch when it is adhered or otherwise secured to a body of an ostomate, e.g. with the ostomate in a standing position, irrespective of whether the ostomy pouch is currently performing such a use or the actual position of the ostomate. The terms “upper” and “lower” and related terms refer to the relative position of a part or portion of the ostomy pouch when orientated as it may be in use. For example, a section of the ostomy pouch may be referred to as an “upper” section of the ostomy pouch. In such an example, said section will be intended to be the uppermost section (in the vertical direction) of the ostomy pouch when attached to the body of a standing ostomate. However the reader skilled in the art will appreciate that before attachment to the ostomate said section may not always be the uppermost section and in addition when attached the section may not always be the uppermost section if the ostomate adopts a non-standing position, for example lying down.
[0078] The terms “left-hand” and “right-hand” and related terms may refer to the ostomy pouch when viewed from the rear (for example, as shown in
[0079] The terms “concave” and “convex” and related terms refer to shaping of features of the ostomy pouch when viewed from an exterior of the ostomy pouch. Thus, as an illustrative example, an ostomy wafer of circular shape would be considered to have a convexly shaped peripheral edge.
[0080] The terms “inner” and “outer” refer to the relative position of a part or portion of the ostomy pouch with reference to the body of an ostomate when the ostomy pouch is attached (e.g. adhesively or otherwise) to the body of the ostomate. “Inner” refers to a position relatively closer to the body of the ostomate than a comparative position that is “outer”. “Outer” refers to a position relatively further away from the body of the ostomate than a comparative position that is “inner”.
[0081] Ostomy pouches are commonly attached to the body of an ostomate by means of an ostomy wafer which includes an adhesive layer or layers. The ostomy wafer typically has an opening for the stoma sometimes referred to as a starter hole which may be cut to a required size by a user before attachment. The ostomy wafer typically comprises an adhesive layer on a body-facing side for adhering the ostomy wafer to the body of the ostomate. Typically, a release liner covers a body-facing side of the ostomy wafer that is removed by the user prior to fitting to the skin. In this specification, the term “ostomy wafer” may be used interchangeably with the terms “adapter,” “wafer,” “baseplate”, or “layered adhesive wafer.” The “ostomy wafer”, “adapter,” “wafer,” “baseplate”, or “layered adhesive wafer” may form a skin barrier between the ostomate and the pouch. In this specification, the term “ostomy wafer” includes ostomy wafers for a “two-piece appliance” and for a “one-piece appliance”.
[0082] A “two-piece pouch” refers to an ostomy pouch where the ostomy wafer forms part of a separate body fitment component that is attached by a releasable coupling to a pouch. A two-piece pouch permits the body fitment component to be separated from the pouch without damage, so that at least one of the parts continues to be functionally usable. For example, the body fitment component may remain in place on the body of the ostomate. In contrast, a “one-piece pouch” refers to an ostomy pouch where the ostomy wafer is permanently attached to the appliance, to the extent that the ostomy wafer cannot easily be separated without risk of damaging the appliance. A one-piece pouch is intended to be used as an integral unit.
[0083] Ostomy pouches may commonly be configured as “closed” pouches or “open” pouches. In this specification a “closed pouch” refers to an ostomy pouch where it is not intended that stomal output is drained from the cavity. Thus, a closed pouch may typically be configured as a one-use, disposable and non-reusable pouch. In this specification an “open pouch” refers to an ostomy pouch where it is possible for the stomal output to be drained from the cavity and the pouch reused. Thus, an open pouch may be configured as a reusable pouch, such that it can be reused and emptied multiple times whilst attached to the body, although this is not essential. In an open pouch the stomal output may be drained intermittently as instigated by an action of the ostomate or may be drained intermittently or continuously due to the cavity being fluidly connected to a drain, for example a night drain line.
[0084] The use of a closed pouch or an open pouch may be, in part, due to user preference, but equally either a closed or open pouch may be more suited depending on the particular ostomate's needs, and depending on the position of the stoma for the ostomate. For example, for stomas formed via ileostomy the stomal output may tend to be looser and be easily drainable which may lead to an open pouch being suitable. For stomas formed by colostomy, the stomal output may tend to be more solid and may not be readily drained by a user. In such instances, a closed pouch may be more suited.
[0085] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.
[0086]
[0087] The inner and outer walls 18b, 20b are formed of a flexible, plastics sheet material. The pouch 10 also includes inner and outer comfort layers 18a, 20a which overlie respective inner and outer walls 18b, 20b. The comfort layers 18a, 20a are formed of a woven, fabric material and define an outer surface of the pouch 10. In the illustrated embodiment, the inside surfaces of the woven layers are coated with a web of hot-melt adhesive (in the example, EVA), so a single joining operation is able to be used to join the inner comfort layer 18a, the inner wall 18b, the outer wall 20b and the outer comfort layer 20a together, here through welding.
[0088] The outer comfort layer includes first and second parts 20a′, 20a″ which are joined to the outer wall 20b so that the first part 20a partially overlaps the second part 20a″ in an overlap region. In use, the first part 20a and the second part 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 part 20a″ overlies the first part 20a′, however in some instances the outer comfort layer 20a of the pouch 10 may be configured in the opposite sense, with the first part 20a′ provided overlying the second part 20a″.
[0089] The inner wall 18b comprises an opening therein defining a stomal inlet 48 in the pouch 10 for receiving stomal output into the cavity. Here, the stomal inlet 48 is provided within the upper section 12 of the pouch 10. An aperture 46 is provided in the inner comfort layer 18a defining a wafer aperture into which an ostomy wafer 24 is located and positioned over the stomal inlet 48, in use.
[0090] The ostomy wafer 24 includes a central aperture 22, an adhesive region 28, and a removable release liner 25 for exposing the adhesive region 28 which may subsequently be used to secure the pouch 10 to and about the stoma of the ostomate, in use. A tab 26 is provided on the release liner 25 to assist the user in removing the release liner 25. The ostomy wafer 24 is suitably secured to the inner wall 18b, e.g. through use of a further adhesive region. The adhesive region 28 is mouldable to the extent that it may be manipulated to adjust the shape and size the central aperture 22 according to the size and shape of the ostomate's stoma. When used here and throughout the specification, the term “mouldable” is intended to cover a component, here the adhesive region 28, which can be shaped under application of a force (e.g. rolling) by a user. In an alternative arrangement the adhesive region may be configured such that it may be shaped to fit the stoma by a user cutting the region to make the central aperture 22 the required size and shape, for example.
[0091] A separation filter 50 is provided within the pouch 10, positioned between the inner and outer walls 18b, 20b, separating the cavity into two cavity chambers. The separation filter 50 is fluid-permeable, and is operable to filter fluid (i.e. gaseous and liquid) stomal output from solid stomal output. Specifically, and in use, stomal output is received through the stomal inlet 48 into the first chamber of the cavity. This stomal outlet may be both fluid and solid. The separation 50 is arranged to allow passage of fluid stomal output into the second chamber, proximal to the outer wall 20b, whilst retaining the solid stomal output in the first chamber, proximal to the inner wall 18b. In the illustrated embodiment, the separation filter 50 is shaped and sized substantially the same as the inner and outer walls 18b, 20b, and is sealed about its periphery (except in a region proximal to the drain 32) to the inner and outer walls 18b, 20b.
[0092] The illustrated embodiment additionally includes a filter system comprising a vent 30 provided in the outer wall 20b for venting of gaseous stomal output from the cavity. This can advantageously maximise the capacity of the pouch 10 for receiving liquid and solid stomal output, and prevent “bloating” or “ballooning” of the pouch 10 which may adversely affect discreetness of the pouch 10 in use. The filter system is provided within the upper section 12 of the pouch. The vent 30 is provided with an odour filter (e.g. a charcoal or activated carbon filter) for reducing the release of unpleasant odours from the cavity. Here, the odour filter is substantially circular in shape, although other shapes and forms of odour filter are equally applicable, as will be appreciated. The filter is located on the outer surface of the outer wall 20b, proximal to the position of the vent 30 such that gaseous stomal output released through the vent 30 is released from the pouch 10 via the filter.
[0093] In the illustrated embodiment, slits 52 are provided in the outer comfort layer 20a proximal to the position of the vent 30 such that gaseous stomal output release through the vent 30 is released from the pouch 10. Gas may escape through the gap between the first and second parts 20a′, 20a″ and therefore in some instances the slits 52 may not be provided.
[0094] As stated above, pouch 10 is an “open” pouch 10 which includes a drain 32 for draining stomal output from the cavity. The drain 32 comprises a drain aperture 35 formed of an unsealed portion of the periphery of the pouch 10, i.e. a region of the periphery of the inner and outer walls 18b, 20b which is not sealed together. Stomal output may be released from the cavity through the drain aperture 35, in use.
[0095] The drain 32 is integral with the inner and outer walls 18b, 20b, and forms an elongated portion of the pouch 10 which extends downwardly from a 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 aligns with the inner and outer comfort layers 18a, 20a does not extend into the drain 32. The separation filter 50 here is not sealed to the inner and outer walls 18b, 20b at its lowermost edge, allowing for stomal output to drain from both the first and second cavity chambers of the cavity through the drain 32.
[0096] The drain 32 is a deployable drain 32 which is moveable between a deployed position (shown in
[0097] Pursing strips 38a, 38b are provided on opposing sides of the drain 32, with a first pursing strip 38a provided on the portion of the inner wall 18b defining the first segment 33 of the drain 32, and a second pursing strip 38b provided on the portion of the outer wall 20b defining the second segment 34 of the drain 32. The pursing strips 38a, 38b provide localised rigidity to the drain 32 and assist with the opening of the drain aperture 35, in use. Specifically, the pursing strips 38a, 38b may be squeezed laterally to arch the pursing strips 38a, 38b (and hence the inner and outer walls 18b, 20b respectively) in opposing directions to open the drain aperture 35.
[0098] The pursing strips 38a, 38b are largely rectangular but include cut out regions at corners thereof as shown in
[0099] The drain 32 includes a first fastening element in the form of a strip of hook fasteners 40 provided on an outer surface of the inner wall 18b. Specifically, the strip of hook fasteners 40 is provided on the outer surface of the portion of the inner wall 18b defining the third segment 36 of the drain 32. A corresponding second fastening element 42 is provided on a flap 44 attached (e.g. welded with the hot-melt adhesive bonding to the flap, or alternatively adhesively secured, for example using adhesive tape) to an outer surface of the outer comfort layer 20a. The second fastening element similarly takes the form of a strip of hook fasteners 42.
[0100] The flap 44 extends across substantially the entire width of the pouch 10, out towards the sealed periphery of the pouch 10 as shown specifically in
[0101] In use, the drain 32 is moved from the deployed position to the stowed position by folding the drain 32 about fold lines 37, 39 upwards and away from the ostomate, by first bringing the first segment 33 adjacent to and overlying the second segment by folding along fold line 37, and subsequently folding the folded first and second segments 33, 34 about the fold line 39 bringing those segments adjacent to and overlying the third segment 36. Finally, the drain 32 is folded once more bringing the folded drain 32 to a position where it overlies a portion of the outer comfort layer 20a as shown in
[0102] The drain 32 is moved from the stowed position to the deployed position in the opposite manner.
[0103] As discussed 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. In this way, when in the stowed position with the drain 32 folded up and over itself away from the ostomate, the inner wall 18b forms an opaque outer surface of the folded drain 32. Together with the flap 44, and by folding the drain 32 up and over an outer surface of an opaque comfort layer 20a, the opaque outer surface of the drain 32 prevents the contents of the pouch 10 being visible with the drain 32 in the stowed position. This is beneficial from a user point of view where the contents of the pouch may be unsightly, and the ostomate may wish for the contents to be concealed during normal use of the pouch. At the same time, the portion of the outer wall 20b defining the drain 32 is transparent. In this way, when deployed, the outermost surface of the drain 32 is transparent allowing the ostomate/user to view the contents of the pouch 10, and specifically the contents passing through the drain 32 during a draining process. Advantageously, this provides greater control over the draining process.
[0104]
[0105] Where the features of pouch 110 are equivalent to those of pouch 10, like reference numerals have been used. Equivalent features are configured in the same way in pouch 110 as pouch 10 described herein, unless otherwise stated herein. For features that are common, reference should be made to the preceding description also.
[0106] Pouch 110 is formed of an inner wall and an outer wall sealed about their periphery and define a cavity for containing a stomal output. 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 waisted section 113 which is narrower in width than upper and lower sections 112, 114. The pouch 110 is dimensioned approximately equal to the dimensions of pouch 10 discussed herein.
[0107] As with pouch 10, the inner and outer walls are formed of a flexible, plastics sheet material and are provided with inner comfort layer 118a and outer comfort layers formed of woven, fabric material and which overlie respective inner and outer walls. Again, a stomal inlet is provided in the upper section 112 of the pouch 110 for receiving stomal output into the cavity, with an ostomy wafer 124 located within an aperture in the inner comfort layer 118a and positioned over the stomal inlet, in use. The ostomy wafer 124 is configured in the same way as ostomy wafer 24 described hereinabove. The pouch similarly includes a deployable drain 132 configured in substantially the same manner as drain 32 of pouch 10. As with pouch 10, the deployable drain 132 is moveable between a deployed position (shown in
[0108] Pouch 110 differs in that the lower section 114 of pouch 110 is shaped differently, and in particular is more elongated. Here, the lower section 114 of the pouch 110 includes straight edge portions 115a, 115b extending from the waisted section 113 to define a lower section 114 which has a generally rectangular portion proximal to the waisted section 113, and a generally rounded section at a lowermost edge of the pouch 110. The elongated lower section 114 may advantageously have a greater capacity for storing stomal output therein.
[0109]
[0110] Where the features of pouch 210 are equivalent to those of pouch 10, like reference numerals have been used. Equivalent features are configured in the same way in pouch 210 as pouch 10 described herein, unless otherwise stated herein. For features that are common, reference should be made to the preceding description also.
[0111] Pouch 210 is formed of an inner wall and an outer wall sealed about their periphery and define a cavity for containing a stomal output. Again, the cavity includes a first, upper section 212, and a second, lower section 214 which are generally rounded in shape with convex curved edges. The upper and lower sections 212, 214 are separated by a waisted section 213 which is narrower in width than upper and lower sections 212, 214. Whilst similar in shape, the pouch 210 of the third embodiment is somewhat squatter than that of the embodiments discussed above, with a “standard” sized length of 194 mm when the drain is stowed and 256 mm when the drain is deployed, (a “large” size is envisaged with a shape similar to that of the second embodiment and a length of 224 mm stowed, and 286 mm with the drain deployed). Another difference in terms of shape is that the waist curvature radii in this example is 60 mm. Of course those skilled in the art will have no trouble determining suitable alternative sizes and shapes.
[0112] As with pouch 10, the inner and outer walls 218b, 220b are formed of a flexible, plastics sheet material and are provided with inner comfort layer 218a and outer comfort layers 220a formed of woven, fabric material and which overlie respective inner and outer walls. Again, a stomal inlet is provided in the upper section 212 of the pouch 210 for receiving stomal output into the cavity, with an ostomy wafer 224 located within an aperture in the inner comfort layer 218a and positioned over the stomal inlet, in use. The ostomy wafer 224 is configured in the same way as ostomy wafer 24 described hereinabove. The pouch similarly includes a deployable drain 232 configured in substantially the same manner as drain 32 of pouch 10. As with pouch 10, the deployable drain 232 is moveable between a deployed position (shown in
[0113] In addition to the different size, the pouch 210 of the third embodiment differs in that it does not include a separation filter extending the length of the pouch, but rather just a separation panel 250 provided between the inner and outer walls 218b, 220b, in the top half of the pouch, to avoid waste blocking the filter 230 through which stomal gas is vented. It also does not include slits in the outer comfort layers 220a, with gas instead escaping through the gap between the upper and lower comfort layers 220a.
[0114] However, the most notable difference in terms of the invention is that in this third embodiment, the flap 244 on which one of the fasteners 242 is provided extends across the entire width of the pouch 210, out to the sealed periphery of the pouch 210 as shown specifically in
[0115] In use, the drain 232 is moved in exactly the same way as the first embodiment and as in the first embodiment (as shown in
[0116] The one or more embodiments are described above by way of example only. Many variations are possible without departing from the scope of protection afforded by the appended claims.