Ostomy appliances
By designing a foldable filter channel in the intestinal fistula equipment and setting a bend point to prevent the entry of liquid and solid substances, the expansion and movement of the equipment caused by gas accumulation is solved, and the stability and leakage protection effect of the equipment are achieved.
Patent Information
- Application Number
- JP2022561520
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-04-15
- Filing Date
- 2021-04-14
- Publication Date
- 2025-04-16
- Estimated Expiration
- 2041-04-14
AI Technical Summary
The prior art is difficult to effectively solve the problem of expansion caused by gas accumulation in intestinal fistula equipment, resulting in equipment movement, leakage or detachment.
An intestinal fistula device is designed, using a foldable filter channel to prevent the entry of liquid and solid substances by setting bend points in the channel, thereby preventing gas accumulation.
It effectively prevents gas accumulation, reduces the expansion of the equipment, improves the stability of the equipment, and prevents the equipment from moving, leaking or disengaging.
Smart Images

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Abstract
Description
[Technical field]
[0001] The present disclosure relates to an ostomy appliance for managing outflow from a stoma, and in particular to an ostomy appliance including a filter arrangement. The present disclosure further provides a method of manufacturing an ostomy appliance. [Background technology]
[0002] Ostomate appliances come in many forms, attempting to provide a safe and comfortable fit for the ostomate. However, stoma output gas may accumulate in the ostomy appliance, resulting in swelling of the ostomy appliance and increasing the likelihood of the ostomy appliance moving from its original position during use. In addition to forming a visible bulge under the ostomate's clothing, any movement of the ostomate may cause leakage or the ostomy appliance to fall off the ostomate. Thus, the ostomy appliance may include an outlet for stoma output gas to escape from the ostomy appliance. The outlet may employ an odor-absorbing gas filter. However, the outlet and / or filter may become clogged, resulting in swelling of the ostomy appliance, which may still occur.
[0003] US-B-8298201 discloses a filter for an ostomy device, comprising a passage for directing gas to a vent of an ostomy bag, and a protective element included in said passage to prevent solid or semi-liquid waste from blocking the passage. A channel formed by a liquid impermeable layer defines the passage and includes a protective element of an open cell compressible material having memory and a pore size of at least 60 PPI. The protective element extends in the same direction as the flow of gas in the flow path. The channel has an opening providing access to the passage from the interior of the bag, and the passage has another opening connected to the vent of the ostomy bag, optionally via a deodorizing filter.
[0004] US-A-2003 / 0014023 discloses an internal waste collection device. US-B-5250042 discloses an ostomate bag combined with a filter. [Prior art documents] [Patent documents]
[0005] [Patent Document 1] U.S. Patent No. 8,298,201 [Patent Document 2] US Patent Application Publication No. 2003 / 0014023 [Patent Document 3] U.S. Patent No. 5,250,042 Summary of the Invention [Problem to be solved by the invention]
[0006] There is a need for an ostomy appliance that improves the ease of use for ostomates, particularly in the areas of improving the breathability of stoma gas discharged and suppressing the expansion of the ostomy appliance due to stoma gas discharged. [Means for solving the problem]
[0007] As used herein, the term "stoma output" refers to any gas or fluid or solid produced by an ostomate that may be secreted or exit the stoma. Stoma output may include stoma gas, stoma liquid, and stoma solid. As used herein, "stoma" refers to an opening in the body. A stoma is generally a surgical opening in the torso of the body. In some cases, the term "stoma" may also refer to the internal tissue, organ, or part thereof exposed by the opening. As non-limiting examples, the internal tissue may be selected from the colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be an end or loop of the small intestine or large intestine.
[0008] As used herein, the term "ostomate" refers to a subject who may have the use of an ostomy appliance disclosed herein. Although an ostomate typically refers to a subject with a surgical opening, as used herein, "ostomate" may refer to a subject with a stoma, whether the stoma was created by surgery or other means. The term "user" may refer to the ostomate or another person who assists, for example, in emptying the output of the stoma from the cavity.
[0009] As used herein, the ostomy appliances disclosed herein can be used to manage a stoma created by, for example, an esophagostomy, gastrostomy, cholecystostomy, biliary stomy, cecostomy, colostomy, duodenostomy, ileostomy, jejunostomy, appendicostomy, tracheostomy, urinary diversion, nephrostomy, ureterostomy, or cystostomy. The ostomy appliances disclosed herein can be used with additional devices, including, but not limited to, shunts, catheters, plugs, or fecal management systems.
[0010] As used herein, the location and orientation of features may be described with reference to the ostomy appliance being "in use," "at one orientation when in use," or the like. Such terms refer to the intended orientation of the ostomy appliance when secured to the body of an ostomate in a standing position, regardless of whether the ostomy appliance is currently in such use, or the actual position of the ostomate. The terms "upper," "lower," "top," "bottom," and related terms refer to the relative positions of parts or regions of the ostomy appliance when oriented to be in use. For example, the apex of the ostomy appliance may be referred to as the "upper" apex in use of the ostomy appliance. In such an example, the apex would be intended to be the topmost apex (in a vertical direction) of the ostomate appliance when attached to the body of a standing ostomate. However, one of ordinary skill in the art will understand that the apex will not always be the topmost apex prior to fitting to the ostomate, and further, the apex will not always be the topmost apex if the ostomate assumes a non-upright position, such as a recumbent position, when fitted.
[0011] As used herein, the terms "inner" and "outer" refer to the relative location of a portion or area of an ostomy appliance with respect to the ostomate's body when the appliance is attached to the body. "Inner" refers to a location relatively closer to the ostomate's body than a comparable location that would be "outer." "Outer" refers to a location relatively farther from the ostomate's body than a comparable location that would be "inner." As used herein, "periphery" refers to a portion at or toward the edge of the referenced item.
[0012] The present disclosure provides an ostomy appliance comprising at least one appliance wall of a flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall having a stoma inlet for receiving the stoma output and a gas vent for allowing the stoma gas to travel out of the cavity, and a filter arrangement attached to the at least one appliance wall, the filter arrangement having at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, the at least one filter channel inlet being located in the cavity for receiving the stoma output from the cavity, the filter channel outlet being attached in communication with the gas vent for allowing the stoma gas to travel from the at least one filter channel to the gas vent.
[0013] The disclosure also provides a method of manufacturing an ostomy appliance comprising forming at least one appliance wall from a flexible sheet material including a stoma inlet and a gas vent; forming a filter arrangement having at least one filter channel extending from at least one filter channel inlet to a filter channel outlet; attaching the filter arrangement and the at least one appliance wall to one another, whereby the at least one appliance wall forms a cavity for containing a stoma output having stoma gas and stoma liquids and / or stoma solids, the stoma inlet being positioned to receive the stoma output, the gas vent being positioned to allow the stoma gas to travel out of the cavity, the at least one filter channel inlet being positioned in the cavity to receive the stoma output from the cavity, and the filter channel outlet being attached in communication with the gas vent to allow the stoma gas to travel from the at least one filter channel to the gas vent.
[0014] In use, stoma output may be received into the cavity from the stoma inlet. Stoma gas may travel from the cavity to the at least one filter channel inlet, through the at least one filter channel, and out of the ostomy appliance via the at least one filter channel outlet and the gas vent. The gas vent may thus allow stoma gas trapped in the ostomy appliance to travel therefrom and prevent it from bulging outward.
[0015] However, when an ostomate moves around wearing an ostomy appliance, they may change the orientation of the ostomy appliance (e.g., when the ostomy appliance is upside down or on its side while the ostomate is lying down) such that stoma solids and / or stoma liquid contact at least one filter channel inlet. Under such conditions, some stoma solids and / or stoma liquid may enter at least one filter channel from at least one filter channel inlet.
[0016] The filter arrangement may have first and second filter walls of flexible sheet material forming at least one filter channel extending between the first and second filter walls around at least one bend for restricting passage of stoma liquid and / or stoma solids along the at least one filter channel.
[0017] The at least one bend can restrict and / or filter the flow of stoma solids and / or stoma liquid from reaching the filter channel outlet and prevent them from contacting the gas vent. In particular, the at least one bend can create at least one pinch point, which can be blocked by the stoma output when it reaches the at least one bend. When the at least one pinch point is formed, stoma gas can accumulate at the at least one bend, and the pressure can push the first filter wall and the second filter wall apart at the at least one pinch point. As a result, the stoma gas can flow around the at least one bend, functioning as a self-regulating valve, while the stoma solids and / or stoma liquid may not be able to pass beyond the at least one bend. Therefore, the gas vent can effectively release stoma gas because the stoma liquid and stoma solids do not adhere to and are not clogged.
[0018] The at least one filter channel may extend along at least one channel section extending to and / or from the at least one bend. In the at least one channel section, the first and second walls may be substantially parallel to the at least one appliance wall. The filter channel may be folded back on itself about the at least one bend. Thus, a method of forming a filter arrangement may include folding the at least one filter channel back on itself at least once to form the at least one bend. Such an arrangement is beneficial in forming an effective pinch point that helps restrict the flow of stoma solids and / or stoma liquid along the filter channel.
[0019] The at least one filter channel may extend between the first and second filter walls around the first and second bends such that the at least one filter channel is Z-shaped. The use of multiple bends can further restrict the passage of stoma liquid and / or stoma solids.
[0020] At least one of the filter channel inlets and / or filter channel outlets may, in use, be located above the center of the stoma inlet. The first bend may be located above the second bend and / or filter channel inlet and the second bend may be located below the filter channel outlet, such that gravity may help to keep some of the stoma liquid and / or stoma solids from migrating from the second bend towards the filter channel outlet.
[0021] The at least one bend may include a first bend, and the at least one filter channel may include a first channel section extending to the first bend and a second channel section extending from the first bend. The first channel section may extend from the at least one filter channel inlet to the first bend. The at least one bend may include a second bend, and the at least one filter channel may extend along the second channel section from the first bend to the second bend and may include a third channel section extending from the second bend. The third channel section may extend from the second bend to the filter channel outlet.
[0022] The first or second filter wall may form the inside of the at least one bend and may be formed from at least one flexible sheet folded over itself around the at least one bend, or may be formed from a flexible sheet extending from and away from the inside of the at least one bend.The first or second filter wall may form the outside of the at least one bend and may be formed from at least one flexible sheet folded over itself around the at least one bend.
[0023] The first and second channel sections may extend between the ends of the channel sections and between the sides of the channel sections. The at least one filter channel inlet may be at a channel section end of the first channel section. The at least one bend may be between the channel section ends of the first and second channel sections, or the at least one bend may be between the channel section sides of the first and second channel sections. The at least one filter channel may have the first and second channel sections extending in series along one axis prior to folding. The at least one filter channel may be folded back on itself at least once to form the at least one bend between the channel section ends of the first and second channel sections.Thus, in one embodiment, a method includes forming at least one appliance wall including a stoma inlet and a gas vent from a flexible sheet material; and forming a filter arrangement including first and second filter walls of the flexible sheet material forming at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, wherein the at least one filter channel extends between the first and second filter walls around at least one bend, the at least one appliance wall forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the stoma inlet being arranged to receive the stoma output, the gas vent being arranged to allow stoma gas to travel out of the cavity, and the at least one filter channel inlet being arranged to receive the stoma output. and a filter arrangement and at least one appliance wall are attached to one another such that the filter arrangement is disposed in a cavity at a stoma outlet and is disposed to receive a stoma output from the cavity, a filter channel outlet is attached in communication with a gas vent to allow transfer of stoma gas from the at least one filter channel to the gas vent, and at least one bend is disposed to restrict passage of stoma liquid and / or stoma solids along the at least one filter channel, wherein the at least one filter channel has first and second channel sections extending along a single axis in series prior to folding, and is folded back on itself at least once to form at least one bend between the channel section ends of the first and second channel sections.
[0024] The at least one filter channel may have a first channel section and a second channel section that extend parallel to each other before folding. The at least one filter channel may fold at least once to form at least one bend between sides of the channel section of the first channel section and the second channel section. Thus, in one embodiment, a method for manufacturing a filter arrangement includes forming at least one appliance wall from a flexible sheet material including a stoma inlet and a gas vent, and forming a filter arrangement including a first filter wall and a second filter wall of the flexible sheet material forming at least one filter channel extending from the at least one filter channel inlet to a filter channel outlet, wherein the at least one filter channel extends between the first filter wall and the second filter wall around the at least one bend, the at least one appliance wall forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the stoma inlet is arranged to receive the stoma output, the gas vent is arranged to allow stoma gas to travel out of the cavity, the at least one filter channel inlet is in the cavity and the gas vent is arranged to allow stoma gas to travel out of the cavity, the at least one filter channel inlet is in the cavity and the filter arrangement includes a first filter wall and a second filter wall of the flexible sheet material forming at least one filter channel extending from the at least one filter channel inlet to a filter channel outlet, wherein the at least one filter channel extends between the first filter wall and the second filter wall around the at least one bend, the at least one appliance wall forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the stoma inlet is arranged to receive the stoma output, the gas vent is arranged to allow stoma gas to travel out of the cavity, the at least one filter channel inlet is in the cavity and the filter arrangement includes a first filter wall and a second filter wall of the flexible sheet material forming at least one filter channel extending from the at least one filter channel inlet to a filter channel outlet, wherein the at least one filter channel extends between the first filter wall and the second filter wall around the at least one bend, the at least one filter channel extending from the at least one filter a filter arrangement and at least one appliance wall attached to one another such that a filter channel outlet is attached in communication with a gas vent to allow transfer of stoma gas from the at least one filter channel to the gas vent, and at least one bend is arranged to restrict passage of stoma liquid and / or stoma solids along the at least one filter channel, wherein the at least one filter channel includes a first channel section and a second channel section extending parallel to one another prior to folding, and wherein the at least one filter channel is folded back upon itself at least once to form at least one bend between sides of the channel sections of the first channel section and the second channel section.
[0025] The ostomy appliance may further comprise at least one gas filter element disposed adjacent the gas vent. The at least one gas filter element may be disposed in the at least one filter channel adjacent the filter channel outlet. The gas vent may be located in a top half of the ostomy appliance, in use, and may define an opening in at least one of the at least one appliance walls.
[0026] The at least one appliance wall may have an inner wall and an outer wall. The inner wall and the outer wall may be joined, preferably around a peripheral joint. The filter arrangement may be located between the inner wall and the outer wall and may be attached to the inner wall and / or the outer wall, such as at least in part by the peripheral joint.
[0027] The filter arrangement may include a first filter channel and a second filter channel extending from a first filter channel inlet and a second filter channel inlet, respectively, to a filter channel outlet. Each of the first filter channel and the second filter channel may extend between the first filter wall and the second filter wall around at least one bend to restrict the passage of stoma liquid and / or stoma solids along the first filter channel and the second filter channel. Having multiple filter channels increases gas flow to the filter channel outlet and further reduces bulging. The first filter channel and the second filter channel may extend substantially perpendicular to each other from the gas vent.
[0028] Thus, in one embodiment, there is provided a filter arrangement comprising at least one appliance wall of flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall comprising a stoma inlet for receiving the stoma output and a gas vent for allowing stoma gas to move out of the cavity, and first and second filter walls of flexible sheet material attached to the at least one appliance wall and forming at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, the at least one filter channel inlet being located in the cavity for receiving the stoma output from the cavity and the filter channel outlet being located in the gas vent for allowing stoma gas to move from the at least one filter channel to the gas vent. and a filter arrangement mounted in communication with the gas vent, wherein at least one filter channel extends between the first and second filter walls around at least one bend for restricting the passage of stoma liquid and / or stoma solids along the at least one filter channel, and the ostomy appliance further comprises first and second filter channels extending from the first and second filter channel inlets to filter channel outlets, respectively, each of the first and second filter channels extending between the first and second filter walls around at least one bend for restricting the passage of stoma liquid and / or stoma solids along the first and second filter channels, and the first and second filter channels extending substantially perpendicular to each other from the gas vent.
[0029] The filter arrangement may include at least one separation element extending at least partially along the at least one filter channel for maintaining the at least one filter channel in an open configuration along at least a portion of the at least one filter channel for passing stoma gas. In particular, the at least one separation element may extend at least partially along the at least one filter channel for separating the first and second filter walls from each other along at least a portion of the at least one filter channel. The separation element may extend around at least one bend. Thus, the separation element prevents the first and second filter walls from adhering to each other and the filter channel from adhering to itself to form a restriction in the at least one filter channel.
[0030] The separation element may have a mesh. The mesh is particularly preferred because it can provide a complex path sufficient to prevent the passage of stoma liquid and stoma solids, but at least one mesh channel can allow the flow of stoma gas. The mesh may be rigid. The mesh may be composed of a regular arrangement of weft and warp threads. The at least one separation element may include at least one separation element channel and / or the mesh may include at least one mesh channel extending therethrough for passing stoma gas through the at least one separation element or mesh to the filter channel outlet. The at least one separation channel may be formed between adjacent warp threads or adjacent weft threads of the at least one mesh. As a result, the at least one separation element channel can always ensure a gas path to the filter channel outlet.Thus, in one embodiment, an apparatus is provided comprising at least one appliance wall of a flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall having a stoma inlet for receiving the stoma output and a gas vent for allowing the stoma gas to travel out of the cavity; and a filter arrangement attached to the at least one appliance wall, at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, the at least one filter channel inlet being located in the cavity for receiving the stoma output from the cavity and the filter channel outlet being located in the cavity for allowing the stoma gas to travel from the at least one filter channel to the gas vent. and at least one separation element extending along the at least one filter channel for maintaining the at least one filter channel in an open configuration along at least a portion of the at least one filter channel to allow stoma gas to pass therethrough, the at least one separation element including at least one mesh, the at least one separation element having at least one separation element channel for stoma gas to pass through the at least one separation element toward a filter channel outlet, the at least one separation channel being formed between adjacent warp yarns or adjacent weft yarns of the at least one mesh.
[0031] In combination with the above-mentioned embodiments, the filter arrangement may comprise first and second filter walls of a flexible sheet material forming at least one filter channel, the at least one filter channel having at least one separating element extending between the first and second filter walls around at least one bend for restricting the passage of stoma liquid and / or stoma solids along the at least one filter channel.
[0032] Alternatively, the filter arrangement may be comprised of filter walls that overlap one another to form at least one filter channel, with channel sections formed between the filter walls, and the channel sections may be fluidly connected by at least one opening through the filter walls.
[0033] The at least one separation element may have a hollow housing and at least one mesh disposed within the housing and extending along at least a portion of the housing. The hollow housing may extend from at least one housing inlet to at least one housing outlet. The at least one housing outlet may be aligned with a filter channel outlet. The at least one housing inlet may be disposed adjacent to the at least one filter channel inlet. Thus, in one embodiment, an apparatus is provided comprising at least one appliance wall of a flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall comprising a stoma inlet for receiving the stoma output and a gas vent for allowing the stoma gas to move out of the cavity, and a filter arrangement attached to the at least one appliance wall, at least one filter channel extending from the at least one filter channel inlet to the filter channel outlet, the at least one filter channel inlet being located within the cavity for receiving the stoma output from the cavity and the filter channel outlet being located within the cavity for allowing the stoma gas to move from the at least one filter channel to the gas vent. and at least one separation element extending at least partially along the at least one filter channel to maintain the at least one filter channel in an open configuration along at least a portion of the at least one filter channel to allow stoma gas to pass therethrough, the at least one separation element including a hollow housing and at least one mesh located within the housing and extending along at least a portion of the housing, the hollow housing extending from at least one housing inlet to at least one housing outlet, the at least one housing outlet aligned with a filter channel outlet.
[0034] The at least one filter channel may extend in a serpentine manner between the filter wall and the at least one instrument wall and may include a plurality of filter channel sections partially separated from one another by attachment lines between the filter wall and the at least one instrument wall.
[0035] The ostomy appliance may further include a shielding wall extending partially between the inner and outer walls and positioned to overlap the stoma entrance such that the shielding wall is capable of deflecting stoma output downwardly away from the stoma entrance.
[0036] Thus, in one embodiment, there is provided at least one appliance wall of a flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall having a stoma inlet for receiving the stoma output and a gas vent for allowing the stoma gas to migrate out of the cavity; and a filter arrangement attached to the at least one appliance wall, at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, the at least one filter channel inlet being located in the cavity for receiving the stoma output from the cavity; and a filter arrangement including a filter channel, the filter channel outlet including a filter channel mounted in communication with a gas vent to allow stoma gas to travel from the at least one filter channel to the gas vent, and at least one separation element extending at least partially along the at least one filter channel to maintain the at least one filter channel in an open configuration along at least a portion of the at least one filter channel to allow stoma gas to pass therethrough, wherein the at least one appliance wall includes an inner wall and an outer wall and further includes a shielding wall extending partially between the inner wall and the outer wall and positioned to overlap the stoma entrance.
[0037] Further, in an alternative embodiment of the present invention, there is provided an appliance comprising at least one appliance wall of flexible sheet material forming a cavity for containing a stoma output including stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall having a stoma inlet for receiving the stoma output and a gas vent for allowing stoma gas to travel out of the cavity, and a filter arrangement attached to the at least one appliance wall, the filter arrangement having first and second filter walls of flexible sheet material forming at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, the at least one filter channel being configured to pass through the at least one filter channel. and a filter arrangement, wherein a filter inlet is positioned in the cavity for receiving a stoma output from the cavity, a filter channel outlet is attached in communication with the gas vent for allowing stoma gas to travel from the at least one filter channel to the gas vent, and the at least one filter channel extends between first and second filter walls around at least one bend for restricting passage of stoma liquid and / or stoma solids along the at least one filter channel, the at least one appliance wall having an inner wall and an outer wall, and further comprising a shield wall extending partially between the inner and outer walls and positioned to overlap the stoma inlet.
[0038] The shielding wall may be attached to the inner and / or outer walls such that a gas path is formed between the shielding wall and the at least one filter channel inlet. Thus, one embodiment of the present invention comprises at least one appliance wall of flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall having a stoma inlet for receiving the stoma output and a gas vent for allowing the stoma gas to move out of the cavity, and a filter arrangement attached to the at least one appliance wall, the filter arrangement having first and second filter walls of flexible sheet material forming at least one filter channel extending from the at least one filter channel inlet to a filter channel outlet, the at least one filter channel inlet being connected to the cavity for receiving the stoma output from the cavity. and a filter arrangement located at a location adjacent to the stoma wall, the filter channel outlet being attached in communication with the gas vent to allow stoma gas to travel from the at least one filter channel to the gas vent, the at least one filter channel extending between the first and second filter walls around at least one bend to restrict passage of stoma liquid and / or stoma solids along the at least one filter channel, the at least one appliance wall including an inner wall and an outer wall and further including a shielding wall positioned to extend partially between the inner and outer walls and overlap the stoma inlet, the shielding wall being attached to the inner and / or outer wall such that a gas pathway is formed between the shielding wall and the at least one filter channel inlet.
[0039] Accordingly, the present disclosure provides an ostomy appliance comprising inner and outer walls of a flexible sheet material forming a cavity for containing a stoma output, the inner wall including a stoma entrance for receiving the stoma output, and a shielding wall of flexible sheet material extending between the inner and outer walls across the stoma entrance, the shielding wall including a spacer arrangement for at least partially separating the shielding wall from the inner and / or outer walls to form a fluid pathway therebetween, the spacer arrangement including at least one undulation in the flexible sheet material of the shielding wall.
[0040] The present disclosure further provides a method of manufacturing an ostomy appliance comprising: attaching inner and outer walls of a flexible sheet material together to form a cavity for containing a stoma output, wherein the inner wall includes a stoma entrance for receiving the stoma output; attaching a shielding wall of flexible sheet material to the inner and / or outer walls such that the shielding wall extends across the stoma entrance; and forming at least one undulation in the flexible sheet material of the shielding wall to form a spacer arrangement at least partially separating the shielding wall from the inner and / or outer wall to form a fluid pathway therebetween.
[0041] In such an arrangement, the outer wall may include a gas vent for allowing stoma gas of the stoma output to travel out of the cavity, and the fluid pathway allows the stoma gas to reach the gas vent. The ostomy appliance may further comprise a filter arrangement attached across the gas vent for allowing stoma gas to travel from the cavity through the filter arrangement and out of the ostomy appliance via the gas vent. The filter arrangement may be as disclosed herein. The at least one undulation may form a fluid pathway extending adjacent the shielding wall to at least one filter channel inlet. The shielding wall may be attached and positioned between the filter arrangement and the inner wall.
[0042] By maintaining a fluid pathway, stoma gases can effectively flow from the stoma inlet through the shield wall and the inner wall, and between the shield wall and the outer wall, to the filter channel inlet. The shield wall can thus prevent stoma output from passing through the stoma inlet and directly contacting any filter arrangement.
[0043] The shielding wall may include a flexible sheet material extending across an area of the shielding wall. The shielding wall may overlap the inner wall and / or the outer wall across the overlapping portions of the inner wall and / or the outer wall. The area of the shielding wall may be greater than the area of the overlap. Thus, the at least one undulation may be formed by an area of excess flexible sheet material of the shielding wall relative to the overlapping areas of the inner wall and / or the outer wall. As a result, the spacer arrangement may be formed solely from flexible sheet material. The thickness of the flexible sheet material of the shielding wall may be constant across the at least one undulation.
[0044] The shielding wall may extend from a top of the ostomy appliance between the sides of the ostomy appliance. The shielding wall may extend to a bottom side spaced from the bottom edge of the cavity to allow stoma output to pass between the bottom edge and the bottom edge of the cavity. The shielding wall may extend from a top of the ostomy appliance between the sides of the ostomy appliance to a bottom side spaced from the bottom edge of the cavity to allow stoma output to pass between the bottom edge and the bottom edge of the cavity. The shielding wall may have a substantially impermeable region facing and generally overlapping the stoma entrance.
[0045] The shield wall may include at least one shield wall opening therethrough, the at least one shield wall opening being positioned adjacent to but not overlapping with the stoma entrance. The at least one shield wall opening may help prevent additional and unnecessary wrinkles from forming in the shield wall that may impede the flow of stoma gas.
[0046] The flexible sheet material of the shielding wall can extend across a substantially flat plane prior to forming the at least one undulation. Forming the at least one undulation may include moving at least a portion of the flexible sheet material of the shielding wall out of the flat plane. Forming the at least one undulation may occur during attachment of the shielding wall to the interior wall and / or the exterior wall. Thus, in one embodiment, there is provided a method of manufacturing an ostomy appliance comprising attaching inner and outer walls of a flexible sheet material together to form a cavity for accommodating stoma output, wherein the inner wall includes a stoma entrance for receiving the stoma output, attaching a shielding wall of flexible sheet material to the inner and / or outer wall such that the shielding wall extends across the stoma entrance, forming at least one undulation in the flexible sheet material of the shielding wall to form a spacer arrangement to at least partially separate the shielding wall from the inner and / or outer wall to form a fluid pathway therebetween, the method further comprising forming at least one undulation between attachment of the shielding wall to the inner and / or outer wall.
[0047] The method may include disposing a shielding wall over the inner wall or the outer wall. The method may include moving at least a portion of the shielding wall relative to the inner wall or the outer wall to form the at least one undulation. The method may include attaching the shielding wall to the inner wall and / or the outer wall to maintain the at least one undulation of the shielding wall. Thus, in one embodiment, there is provided a method of manufacturing an ostomy appliance comprising attaching inner and outer walls of a flexible sheet material together to form a cavity for accommodating stoma output, wherein the inner wall includes a stoma entrance for receiving the stoma output, attaching a shielding wall of flexible sheet material to the inner and / or outer walls such that the shielding wall extends across the stoma entrance, and forming at least one undulation in the flexible sheet material of the shielding wall to form a spacer arrangement to at least partially separate the shielding wall from the inner and / or outer walls to form a fluid pathway therebetween, the method further comprising positioning the shielding wall over the inner or outer wall, moving at least a portion of the shielding wall relative to the inner or outer wall to form the at least one undulation, and attaching the shielding wall to the inner and / or outer wall to maintain the at least one undulation of the shielding wall.
[0048] After the shielding wall is positioned over the interior or exterior wall, the shielding wall may be partially attached to the interior or exterior wall. Thus, in one embodiment, there is provided a method of manufacturing an ostomy appliance comprising attaching inner and outer walls of a flexible sheet material together to form a cavity for containing a stoma output, wherein the inner wall includes a stoma entrance for receiving the stoma output, attaching a shielding wall of flexible sheet material to the inner and / or outer walls such that the shielding wall extends across the stoma entrance, and forming at least one undulation in the flexible sheet material of the shielding wall to form a spacer arrangement to at least partially separate the shielding wall from the inner and / or outer walls to form a fluid pathway therebetween, the method further comprising disposing the shielding wall over the inner or outer wall, moving at least a portion of the shielding wall relative to the inner or outer wall to form the at least one undulation, and attaching the shielding wall to the inner and / or outer wall to maintain the at least one undulation in the shielding wall, wherein after disposing the shielding wall over the inner or outer wall, the shielding wall is partially attached to the inner or outer wall.
[0049] The ostomy appliance may be a closed or open appliance. A closed appliance is not configured to allow the stoma output to be discharged from the cavity. Thus, a closed appliance may typically be configured as a one-time disposable, non-reusable appliance. In the ostomy appliance of the present disclosure, the cavity may therefore be completely sealed within the ostomy appliance from the outside environment, except through the gas vent and the stoma inlet. An open appliance is configured to allow the stoma output to be discharged from the cavity. Thus, an open appliance may be configured as a reusable appliance so that it can be reused and emptied multiple times while worn on the body, but this is not required. In an open appliance, the stoma output may be discharged intermittently as triggered by the ostomate's actions, or may be discharged intermittently or continuously because the cavity is fluidly connected to a drain. Thus, the ostomy appliance of the present disclosure may include a selectively openable drain to allow the stoma output to be selectively discharged from the cavity.
[0050] Thus, in one embodiment, an apparatus is provided comprising at least one appliance wall of a flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall comprising a stoma inlet for receiving the stoma output and a gas vent for allowing the stoma gas to travel outside the cavity; and a filter arrangement attached to the at least one appliance wall, at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, the at least one filter channel inlet being located within the cavity for receiving the stoma output from the cavity, the filter channel outlet being located within the cavity for receiving the stoma output from the cavity, and the filter channel outlet being located within the cavity for receiving the stoma gas from at least one filter channel inlet. and a filter arrangement including a filter channel attached in communication with the gas vent to allow gas to pass from the filter channel to the gas vent, and at least one separation element extending at least partially along the at least one filter channel to maintain the at least one filter channel in an open configuration along at least a portion of the at least one filter channel to allow stoma gas to pass therethrough, the ostomy appliance further comprising a selectively openable and closable drain to selectively vent the stoma output from the cavity or the cavity is sealed within the ostomy appliance other than through the gas vent and the stoma inlet.
[0051] Further, in an alternative embodiment, there is provided an appliance comprising at least one appliance wall of flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall including a stoma inlet for receiving the stoma output and a gas vent for allowing the stoma gas to travel out of the cavity, and a filter arrangement attached to the at least one appliance wall, the filter arrangement having first and second filter walls of flexible sheet material forming at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, the at least one filter channel inlet directing the stoma output from the cavity. and a filter arrangement positioned in the cavity to receive the stoma gas, the filter channel outlet being attached in communication with the gas vent to allow stoma gas to travel from the at least one filter channel to the gas vent, the at least one filter channel extending between the first filter wall and the second filter wall around at least one bend to restrict passage of stoma liquid and / or stoma solids along the at least one filter channel, the ostomy appliance further comprising a selectively openable and closable drain to selectively allow stoma output to drain from the cavity, or the cavity is sealed within the ostomy appliance other than through the gas vent and the stoma inlet.
[0052] The ostomate appliance may include a seal for attachment to the ostomate's body. The ostomy seal may have an opening for the stoma and may be cut to the required size by the user before application. The ostomy seal may include at least one adhesive layer on the body-facing side to adhere the ostomy seal to the ostomate's body. A release liner may cover the body-facing side of the ostomy seal that is removed by the user before application to the skin. The term "seal" may be used interchangeably with the terms "adapter", "base plate" and "layered adhesive seal".
[0053] The ostomy appliance may be a one-piece appliance and may include a paper seal non-releasably attached to the inner wall around the stoma opening such that the ostomy paper seal cannot be easily separated without risk of damaging the appliance. The ostomy appliance may be a two-piece appliance and may include a releasable coupling attached to the inner wall around the stoma opening and a paper seal attached to the releasable coupling such that the coupling can be disengaged to separate the paper seal from the remainder of the ostomy appliance. The ostomy paper seal and / or the releasable coupling may be at least partially disposed in an upper peripheral region of the ostomy appliance.
[0054] Thus, in one embodiment, an apparatus is provided comprising at least one appliance wall of a flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall comprising a stoma inlet for receiving the stoma output and a gas vent for allowing the stoma gas to travel outside the cavity; and a filter arrangement attached to the at least one appliance wall, at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, the at least one filter channel inlet being located within the cavity for receiving the stoma output from the cavity, the filter channel outlet being located within the cavity for allowing the stoma gas to pass through at least one filter channel inlet. and a filter arrangement including a filter channel attached in communication with the gas vent to allow passage of stoma gas from the filter channel to the gas vent, and at least one separation element extending at least partially along the at least one filter channel to maintain the at least one filter channel in an open configuration along at least a portion of the at least one filter channel to allow passage of stoma gas therethrough, the ostomy appliance further including a seal paper non-releasably attached to at least one appliance wall about the stoma entrance, or a releasable coupling attached to at least one appliance wall about the stoma entrance and a seal paper attached to the releasable coupling.
[0055] Further, in an alternative embodiment, there is provided an appliance comprising at least one appliance wall of flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the at least one appliance wall comprising a stoma inlet for receiving the stoma output and a gas vent for allowing the stoma gas to travel out of the cavity, and a filter arrangement attached to the at least one appliance wall, the filter arrangement comprising first and second filter walls of flexible sheet material forming at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, the at least one filter channel inlet being connected to the cavity for receiving the stoma output from the cavity. and a filter arrangement located in the first filter wall and the second filter wall, the filter channel outlet being attached in communication with the gas vent to allow stoma gas to travel from the at least one filter channel to the gas vent, the at least one filter channel extending between the first filter wall and the second filter wall around at least one bend to restrict passage of stoma liquid and / or stoma solids along the at least one filter channel, the ostomy appliance further comprising a seal paper non-releasably attached to the at least one appliance wall around the stoma entrance, or a releasable coupling attached to the at least one appliance wall around the stoma entrance and a seal paper attached to the releasable coupling.
[0056] At least one of the appliance wall, the inner wall, the outer wall, the first filter wall, the second filter wall and / or the shielding wall may be formed from the same or different flexible sheet material and may be formed from at least one layer of such flexible sheet material. The flexible sheet may comprise polyurethane, polyethylene (PE), polyvinylidene chloride (PVDC) and / or ethylene-vinyl acetate (EVA). The flexible sheet(s) may have a thickness of about 50 to about 150 micrometers, preferably about 75 to about 100 micrometers. The flexible sheet may be a single layer or a laminate of multiple layers. [Brief description of the drawings]
[0057] [Figure 1] FIG. 1 is a front view of one embodiment of an ostomy appliance according to the present disclosure. [Diagram 2] FIG. 2 is a cross-sectional view of the ostomy device of FIG. 1 taken along line AA. [Diagram 3] FIG. 3 is a cross-sectional view through section BB of the ostomy appliance of FIG. 1 with the separating element of the filter arrangement hidden from view. [Figure 4] FIG. 4 is a partial cross-sectional view through section BB of the ostomy appliance of FIG. 1 showing the separation element of the filter arrangement. [Diagram 5] FIG. 5 is a partial front view of a further embodiment of an ostomy appliance according to the present invention in which the filter arrangement is separate from the peripheral welds of the ostomy appliance. [Figure 6A] FIG. 6A is a perspective view illustrating the steps of forming the filter arrangement of FIGS. 1 to 5. FIG. [Figure 6B] FIG. 6B is a perspective view illustrating a step of forming the filter arrangement of FIGS. 1 to 5. FIG. [Figure 6C] FIG. 6C is a perspective view illustrating a step of forming the filter arrangement of FIGS. 1-5. [Figure 6D] FIG. 6D is a perspective view illustrating a step of forming the filter arrangement of FIGS. 1-5. [Figure 6E] FIG. 6E is a perspective view illustrating a step of forming the filter arrangement of FIGS. 1-5. [Figure 6F] FIG. 6F is a perspective view illustrating a step of forming the filter arrangement of FIGS. 1-5. [Figure 7A] FIG. 7A is a cross-sectional view through section BB of the ostomy appliance of FIG. 1 showing a further embodiment of a filter arrangement in which the separation element of the filter arrangement is hidden from view. [Figure 7B] FIG. 7B is a perspective view of the filter arrangement of FIG. 6A with the separation element hidden from view. [Figure 8A]FIG. 8A is a perspective view illustrating an alternative method of forming the filter arrangement of FIGS. 1-5. [Figure 8B] FIG. 8B is a perspective view illustrating an alternative method of forming the filter arrangement of FIGS. 1-5. [Figure 9A] 9A is a perspective view of one embodiment of a separation element of the ostomy appliance illustrated in FIG. [Figure 9B] 9B is a cross-sectional view across the width of a filter channel of the filter arrangement of the ostomy appliance of FIG. 1 including the separation element of FIG. [Figure 10A] FIG. 10A is a perspective view illustrating a further embodiment of a filter arrangement in respective exploded and configured configurations according to the present disclosure. [Figure 10B] FIG. 10B is a perspective view illustrating a further embodiment of a filter arrangement in respective exploded and configured configurations according to the present disclosure. [Figure 10C] FIG. 10C is a cross-sectional view through section CC of the filter arrangement shown in FIG. 10B. [Figure 11A] FIG. 11A is a perspective view illustrating a further embodiment of a filter arrangement in respective exploded and formed configurations according to the present disclosure. [Figure 11B] FIG. 11B is a perspective view illustrating a further embodiment of a filter arrangement in respective exploded and formed configurations according to the present disclosure. [Figure 12A] FIG. 12A is a plan view of a further embodiment of an ostomy appliance in accordance with the present disclosure. [Figure 12B] FIG. 12B is a cross-sectional view of the ostomy device of FIG. 11A through section DD. [Figure 13A] FIG. 13A is a perspective view showing a step of forming the ostomy appliance of FIG. 1 having a shield wall. [Figure 13B] FIG. 13B is a perspective view showing a step of forming the ostomy appliance of FIG. 1 having a shield wall. [Figure 13C] FIG. 13C is a perspective view illustrating a step of forming the ostomy appliance of FIG. 1 having a shield wall. [Figure 14A]FIG. 14A is a plan view showing a step of attaching the shield wall of FIG. 13A to the outer wall of the ostomy appliance. [Figure 14B] FIG. 14B is a plan view showing a step of attaching the shield wall of FIG. 13B to the outer wall of the ostomy appliance. [Figure 14C] FIG. 14C is a plan view showing a step of attaching the shield wall of FIG. 13C to the outer wall of the ostomy appliance. [Figure 15A] FIG. 15A is a perspective view of the outer wall and shield wall attached together as in FIG. 14C with the spacer arrangement illustrated. [Figure 15B] FIG. 15B is a partial cross-sectional view of the outer wall and shield wall attached together through section EE of FIG. 14C with the location of the inner wall in the assembled ostomy appliance shown in dashed lines for reference. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0058] One or more embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings.
[0059] In the following description, in different embodiments, the same reference numerals are used to indicate the same or similar features. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the subject matter of the claims belongs. It is understood that the above summary of the disclosure and the following examples are exemplary and explanatory and are not intended to limit any subject matter claimed.
[0060] The following description is directed to embodiments of the present disclosure. The description of the embodiments is not meant to include all possible embodiments of the present disclosure as described in the appended claims. Many modifications, improvements, and equivalents not expressly described in the following embodiments may be included within the scope of the appended claims. Features described as part of an embodiment may be combined with features of one or more other embodiments, unless the context clearly requires otherwise.
[0061] It is understood that at least some of the figures and descriptions of the present disclosure have been simplified to focus on elements relevant to a clear understanding of the present disclosure, while excluding other elements that would be understood by a person skilled in the art for the sake of clarity may be required. Because such elements are well known to those skilled in the art and do not necessarily enhance an understanding of the present disclosure, descriptions of such elements are omitted herein.
[0062] As used herein, the use of the singular includes the plural unless the context clearly dictates otherwise. In this application, the use of "or" means "and / or" unless stated otherwise.
[0063] As used herein, ranges and amounts may be expressed as "about" a particular value or range. About also describes the exact amount. For example, "about 5 mm" means "about 5 mm" and also means "5 mm". In general, the term "about" includes values that are expected to be within experimental error. The term "about" includes values that are 10% smaller to 10% larger than the provided value. For example, "about 50%" means "between 45% and 55%". Also, for example, "about 30" means "between 27 and 33".
[0064] 1-4 illustrate one embodiment of an ostomy device 10 according to the present disclosure. The ostomy device 10 may include a seal and / or a coupling (not shown) and may be a one-piece or two-piece device.
[0065] The ostomy appliance 10 may include at least one appliance wall 11, 12 of flexible sheet material forming a cavity 13 for accommodating the stoma output. The at least one appliance wall 11, 12 may form the exterior of the ostomy appliance 10 and may, as shown, have an inner wall 11 and an outer wall 12. While the cavity 13 is shown as a single volume, in alternative embodiments it may be subdivided into two or more chambers by, for example, a partition, wall member, filter element, etc.
[0066] Prior to initial use and stoma output entering cavity 13, ostomy appliance 10 may have a substantially flat configuration. In the flat configuration, ostomy appliance 10 has a substantially flat planar shape, with inner wall 11 and outer wall 12, and any additional dividers or components therebetween, being substantially adjacent to one another.
[0067] At least one of the appliance walls 11, 12, preferably the inner wall 11 as shown, may have a stoma inlet 14 for receiving stoma output from the stoma into the cavity 13. The stoma inlet 14 may be an opening through the inner wall 11. At least one of the appliance walls 11, 12, preferably the outer wall 12 as shown, may have a gas vent 15 for transferring stoma gases out of the cavity 13. The gas vent 15 may have at least one opening through the outer wall 12.
[0068] The stoma entrance 14 and gas vent 15 may be located in the upper half of the ostomy appliance 10 in use. The centre of the gas vent 15 may be located above the centre of the stoma entrance 14 in use. Preferably, the entire circumference of the gas vent 15 is located above the entire circumference of the stoma entrance 14 in use, as shown in Figure 1. The term "above" is intended to mean that the gas vent 15 is located at the very top of the stoma entrance 14 in use, along a line parallel to the inner wall 11 and the outer wall 12 when in the flat configuration.
[0069] The diameter of the at least one opening of the gas vent 15 may be smaller than the diameter of the stoma entrance 14. The diameter of the at least one opening of the gas vent 15 may be at least about 1 mm, may be up to about 10 mm, and / or may be about 5 mm. The diameter of the stoma entrance 14 may be at least about 10 mm, may be up to about 60 mm, and / or may be about 45 mm. The distance between the top of the ostomy appliance 10 and the center of the stoma entrance 14 during use may be at least about 40 mm, may be up to about 60 mm, and / or may be about 49 mm or about 50 mm.
[0070] At least one of the appliance walls 11, 12 may be joined together to define a cavity 13 therebetween. The inner wall 11 and the outer wall 12 may be joined together around their perimeter using welding, adhesives or equivalent means such that a peripheral joint 16 extends around the entire perimeter of the inner wall 11 and the outer wall 12 to form a fluid tight seal therebetween. The peripheral joint 16 may be on the order of 1-3 mm in width, preferably 2 mm. In the illustrated embodiment, the ostomy appliance 10 is a closed appliance such that the cavity 13 is sealed within the ostomy appliance 10 except through the stoma entrance 14 and the gas vent 15. In an alternative embodiment, the ostomy appliance 10 may be an open appliance and may have a drain to allow the stoma output to flow out of the cavity 13.
[0071] The ostomy appliance 10, inner wall 11 and outer wall 12 may be substantially quadrilateral in shape as shown. In other embodiments, they may have any other suitable shape, such as circular or oval. The ostomy appliance 10, inner wall 11 and outer wall 12 may have a length of about 120 mm to about 200 mm, preferably about 140 mm to about 160 mm, for example about 145 mm, and a width of about 120 mm to about 200 mm, preferably about 140 mm to about 160 mm, for example about 140 mm or about 145 mm.
[0072] The inner wall 11 and the outer wall 12 may have one or more, preferably four, vertices 17a-d, at least one of which is preferably rounded as shown. The radius of curvature of each rounded vertex 17a-d may be about 30 mm. In use (i.e., when worn by an ostomate), the inner wall 11 and the outer wall 12 may have an upper vertex 17a pointing substantially vertically upward, a lower vertex 17b pointing substantially vertically downward, and opposing side vertices 17c, 17d pointing substantially to each side, as shown by way of example in FIG. 1. The upper vertex 17a may be joined to opposing side vertices 17c, 17d by first and second sides 18a, 18b, respectively. The lower vertex 17b may be joined to opposing side vertices 17c, 17d by third and fourth sides 18c, 18d, respectively. One or more of the first, second, third and fourth sides 18a-d may be straight between their respective vertices 17a-d. If the vertices 17a-d are rounded, the sides 18a-d may be straight between the rounded vertex(s) 17a-d.
[0073] The gas vent 15 may, in use, be located adjacent the top of the ostomy appliance 10. As a result, the gas vent 15 may be located adjacent the top apex 17a between the first side 18a and the second side 18b.
[0074] Cavity 13 may extend between an upper cavity end 13a adjacent the top of ostomy device 10 and a lower cavity end 13b adjacent the bottom of ostomy device 10. Thus, upper cavity end 13a may be adjacent upper apex 17a and lower cavity end 13b may be adjacent lower apex 17b. Additionally, gas vent 15 may be located adjacent cavity upper end 13a.
[0075] The ostomy appliance 10 may include a filter arrangement 20 for allowing stoma gas to exit the cavity 13 via the gas vent 15 and for filtering the passage of stoma solids and / or stoma liquid to prevent them from exiting the cavity 13 via the gas vent 15. The filter arrangement 20 may be attached to at least one of the appliance walls 11, 12, may be attached to at least the outer wall 12 and / or may be attached between the inner wall 11 and the outer wall 12. The filter arrangement 20 may be attached across the gas vent 15.
[0076] In Figures 2-4, the filter arrangement 20 is shown as being separate from the outer wall 12 for clarity, but may be in contact with and attached to the outer wall 12. The filter arrangement 20 may also extend to and be attached to the inner and outer walls 11 and 12 by the peripheral joint 16 as shown in Figure 1 (not shown in Figures 2-4 for clarity). Thus, the filter arrangement 20 may be located adjacent to the top of the ostomy appliance 10 in use, or may extend along the sides of the inner and outer walls 11 and 12. Thus, the filter arrangement 20 may be located adjacent to the top apex 17a between the first and second sides 18a and 18b.
[0077] 5, the filter arrangement 20 may be separated from the peripheral joint 16 and therefore from the sides, preferably the first side 18a and the second side 18b. The filter arrangement 20 may be welded to the outer wall 12 separately from the peripheral joint 16 or adjacent to the peripheral joint 16. As a result, the thickness of the peripheral joint 16 can be reduced, improving manufacturability and flexibility.
[0078] 3, 4 and 6A-6F, the filter arrangement 20 may include a first filter wall 21 and a second filter wall 22 of a flexible sheet material. The first filter wall 21 and the second filter wall 22 may define at least one filter channel 23, 24 therebetween that extends from at least one filter channel inlet 25, 26 to at least one filter channel outlet 27. In particular, the at least one filter channel 23, 24 may be formed between major surfaces of the flexible sheet material of the first filter wall 21 and the second filter wall 22.
[0079] The first filter wall 21 and the second filter wall 22 may comprise at least one strip of flexible sheet material joined together along at least one channel side 50, 51, preferably the first channel side 50 and the second channel side 51, and at least one filter channel 23, 24 may extend between faces of the flexible sheet material along at least one channel side 50, 51. The first filter wall 21 and the second filter wall 22 may each be constructed from a single continuous layer or strip of flexible sheet material forming at least one filter channel 23, 24, as shown in Figures 3, 4 and 6A-6F.
[0080] At least one filter channel inlet 25, 26 may be for receiving stoma output from cavity 13 and may therefore be located in cavity 13. If cavity 13 is divided into multiple chambers, at least one filter channel inlet 25, 26 is preferably located in at least a chamber through which stoma gas can travel.
[0081] At least one filter channel outlet 27 may be mounted in communication with the gas vent 15 to allow stoma gas to migrate from at least one filter channel 23, 24 to the gas vent 15. The filter channel outlet 27 may be located adjacent to and aligned with the gas vent 15 such that stoma gas may pass from the filter channel outlet 27 through the gas vent 15 to the external environment surrounding the ostomy appliance 10. The filter channel outlet 27 may be disposed through the first filter wall 21 or the second filter wall 22 and may have an opening therein as shown. The first filter wall 21 or the second filter wall 22 constituting the filter channel outlet 27 may be mounted on and around the gas vent 15 such that the filter channel outlet 27 overlaps the gas vent 15, for example by bonding the first filter wall 21 or the second filter wall 22 to the outer wall 12.
[0082] 1 and 6A-6F, at least one filter channel 23, 24 may include a first filter channel 23 and a second filter channel 24 extending from a first filter channel inlet 25 and a second filter channel inlet 26, respectively, to a filter channel outlet 27. The first filter channel 23 and the second filter channel 24 may extend in different directions from the gas vent 15, or may extend substantially perpendicular to each other from the gas vent 15 as shown. As a result, the first filter channel 23 and the second filter channel 24 may extend from the gas vent 15 parallel to and along the first side 18a and the second side 18b.
[0083] At least one filter channel 23, 24 may extend between the first filter wall 21 and the second filter wall 22 around at least one bend 30 for restricting the passage of stoma liquid and / or stoma solids along the at least one filter channel 23, 24. In particular, the first filter channel 23 may include at least one bend 30, and the second filter channel 24 may also include at least one bend 30, for restricting the passage of stoma liquid and / or stoma solids along the first filter channel 23 and / or the second filter channel 24.
[0084] The arrangement of the at least one bend 30 is shown in detail in Figures 3 and 4, which show the at least one bend 30, 31 of the first filter channel 23. The following description will generally refer to the first filter channel 23, but it will be understood that the at least one bend 30, 31 (if any) of the second filter channel 24 may have the same features. The same reference numerals are used in the drawings to indicate corresponding features of each of the first filter channel 23 and second filter channel 24.
[0085] The or each filter channel 23, 24 may be folded back on itself about at least one bend 30, 31. The or each filter channel 23, 24 (and flow therealong) may extend to at least one bend 30, 31 in a first direction and extend from at least one bend 30, 31 in an opposite second direction. Thus, or each filter channel 23, 24 may extend parallel to and between the inner wall 11 and the outer wall 12, be folded back on itself about at least one bend 30, 31, and then continue to extend parallel to and between the inner wall 11 and the outer wall 12.
[0086] The or each filter channel 23, 24 may extend along at least one channel section 35, 36, 37 extending into and / or from at least one bend 30, 31, preferably between the first filter wall 21 and the second filter wall 22. In the at least one channel section 35, 36, 37 the first filter wall 21 and the second filter wall 22 are substantially parallel to at least one appliance wall 11, 12, in particular the inner wall 11 and the outer wall 12, when in a flat configuration.
[0087] At least one channel section 35, 36, 37 may have a first channel section 35 extending to the first bend 30 and a second channel section 36 extending from the first bend 30. The first channel section 35 may extend from the respective filter channel inlet 25, 26 to the first bend 30. Although not shown, if at least one bend 30, 31 only has the first bend 30, the second channel section 36 may extend from the first bend 30 to the filter channel outlet 27.
[0088] As in the illustrated embodiment, the or each filter channel 23, 24 may extend between the first filter wall 21 and the second filter wall 22 around the first bend 30 and the second bend 31 such that the or each filter channel 23, 24 has a Z-shaped and / or serpentine path. Thus, a second channel section 36 extends between the first bend 30 and the second bend 31 and at least one channel section 35, 36, 37 has a third channel section 37 extending between the second bend 31 and the filter channel outlet 27.
[0089] The first channel section 35, the second channel section 36, and, if present, the third channel section 37 may extend between the channel section ends, may be elongated between the channel section ends, or may extend between the channel section sides 50, 51. In the embodiments of Figures 3, 4 and 6A-6F, at least one bend 30, 31 is between the channel section ends. As a result, fluid flow around the or each filter channel 23, 24 extends approximately 180 degrees about one axis around the at least one bend 30, 31. Thus, the fluid flow only changes direction about a single axis as it travels around the at least one bend 30, 31 between the channel sections 35, 36, 37.
[0090] In particular, a first channel section 35 may extend between the first channel section ends, with the filter channel inlets 25, 26 located at the first channel section ends and a first bend 30 located at the opposite first channel section end. A second channel section 36 may extend between the second channel section ends, with the first bend 30 located at the second channel section end and a second bend 31 or filter channel outlet 27 located at the opposite second channel section end. A third channel section 37 may extend between the third channel section ends, with the second bend 31 located at the third channel section end and a filter channel outlet 27 located at the opposite third channel section end.
[0091] The length along the or each filter channel 23, 24 from the respective filter channel inlet 25, 26 to the filter channel outlet 27 may be at least about 70 mm, may be up to about 120 mm, and / or may be about 95 mm. The width of the or each filter channel 23, 24 may be at least about 15 mm, may be up to about 30 mm, and / or may be about 22 mm. The first channel section 35 may be at least about 5 mm long, may be up to about 15 mm long, and / or may be about 10 mm long. The second channel section 36 may be at least about 30 mm long, may be up to about 40 mm long, and / or may be about 35 mm long. The third channel section 37 may be at least about 30 mm long, may be up to about 70 mm long, and / or may be about 50 mm long.
[0092] The inner and outer sides of each bend 30, 31 may each be formed from one of the first filter wall 21 and the second filter wall 22. As shown in Figures 3 and 4, the first filter wall 21 or the second filter wall 22 may be formed from a layer of flexible sheet material superimposed on itself around the inner or outer periphery of at least one bend 30, 31. Thus, the inner side of each bend 30, 31 may be formed from two layers of flexible sheet material forming the first filter wall 21 (as in the first bend 30 in Figure 3) or the second filter wall 22 (as in the second bend 31 in Figure 3).
[0093] The ostomy appliance 10 may further include at least one gas filter element 40 disposed adjacent to the gas vent 15. The at least one gas filter element 40 may be disposed in the at least one filter channel 23, 24 adjacent to and above the filter channel outlet 27 as shown, such that stoma gas must pass through the at least one gas filter element 40 to exit the filter channel outlet 27. In alternative embodiments, the at least one gas filter element 40 may be disposed between the filter channel outlet 27 and the gas vent 15, or may be attached to the outside of the outer wall 12 beyond the gas vent 15. In the latter case, the gas vent 15 may further include a filter cap (not shown) disposed over the at least one gas filter element 40. The at least one gas filter element 40 may be an odor filter, such as, for example, a charcoal or activated carbon filter, to reduce odor from the expelled stoma gas. The at least one gas filter element 40 may be a disk, which may be circular, as shown. The diameter of the at least one gas filter element 40 may be at least about 10 mm, may be up to about 20 mm, and / or may be about 15 mm.
[0094] 4, the filter arrangement 20 may further include at least one separation element 45, 46 extending at least partially along the at least one filter channel 23, 24 to separate the first filter wall 21 and the second filter wall 22 from each other along at least a portion of the at least one filter channel 23, 24. The at least one separation element 45, 46 is not shown in FIGS. 3, 7A or 7B so that the first filter channel 23 can be clearly identified.
[0095] At least one separation element 45, 46 may substantially impede or prevent stoma liquid and / or stoma solids from migrating along at least one filter channel 23, 24. At least one separation element 45, 46 may allow stoma gas to travel along at least one filter channel 23, 24 and may define at least one separation element channel 47 for allowing such passage of stoma gas (see FIG. 8A). Filter arrangement 20 may include a first separation element 45 and a second separation element 46 disposed in first filter channel 23 and second filter channel 24, respectively.
[0096] The or each separation element 45, 46 may extend around at least one bend 30, 31 and may extend between at least the first bend 30 and the second bend 31, i.e. along at least the second channel section 36. The or each separation element 45, 46 may extend from at least one filter channel inlet 25, 26, as shown. The or each separation element 45, 46 may extend along at least about 50%, at least about 75% or at least about 85% of the length of the or each filter channel 23, 24 between the respective filter channel inlet 25, 26 and the filter channel outlet 27. In particular, the or each separation element 45, 46 may extend from the respective filter channel inlet 25, 26 around at least one bend 30, 31, preferably around both the first bend 30 and the second bend 31, towards the filter channel outlet 27.
[0097] 6A-6F show an exemplary method for forming the filter arrangement 20 shown in FIGS. 1, 2 and 4, including at least one separation element 45 and first and second filter channels 23 and 24 extending between the first and second filter walls 21 and 22 around the first and second bends 30 and 31. First, the first and second filter walls 21 and 22 may be cut as V-shaped strips from a flexible sheet material, as in FIG. 6A, and the first and second separation elements 45 and 46 may be formed as elongated strips to provide at least one gas filter element 40. The filter channel outlet 27 may be formed by cutting an opening in the first filter wall 21. The twelfth and second separation elements 45 and 46 may be disposed (and optionally attached) on the first filter wall 21, as in FIG. 6B, and at least one gas filter element 40 may be attached above the filter channel outlet 27. As in FIG. 6C, the second filter wall 22 may be disposed over the first filter wall 21, the first and second separation elements 45 and 46, and the at least one gas filter element 40. At least one filter channel joint or weld 70 may then be applied along the first and second channel sides 50 and 51 to connect the first and second filter walls 21 and 22. Prior to folding, the at least one filter channel 23, 24 and its channel sections 35, 36, 37 extend along a single axis and / or in series. As in FIG. 6D and FIG. 6E, the first and second filter channels 23, 24 may be folded back on themselves to form a first bend 30 and a second bend 31 in each of the first and second filter channels 23, 24, whereby the first and second bends 30, 31 are between the channel section ends. As shown in FIG. 6F, additional filter channel bonds or welds 71 may then be applied along first channel side 50 and second channel side 51 to hold filter arrangement 20 in its Z-shape.
[0098] Other configurations of the first and second filter walls 21, 22 and the at least one bend 30, 31 extending between the first and second filter walls 21, 22 are within the scope of the present disclosure. In alternative embodiments, they may instead have multiple layers or strips located adjacent to one another along the at least one filter channel 23, 24. Figures 7A and 7B illustrate an embodiment in which the first and second filter walls 21, 22 are not formed of a continuous strip of flexible sheet material. The inside of the at least one bend 30, 31 may have a single layer of flexible sheet material forming one of the first and second filter walls 21, 22. This single layer may extend from and away from the inside of the at least one bend 30, 31 without being folded back on itself. The outside of the at least one bend 30, 31 may have a layer of flexible sheet material folded back on itself. 7A and 7B, the first filter wall 21 may have one strip-shaped flexible sheet material, and the second filter wall 22 may have two strip-shaped flexible sheet material. The inside of the first bent portion 30 and the outside of the second bent portion 31 may have the strip-shaped first filter wall 21. The outside of the first bent portion 30 may be formed from one strip-shaped second filter wall 22, and the inside of the second bent portion 31 may be formed from the other strip-shaped second filter wall 22.
[0099] Figures 8A and 8B show a further arrangement of a filter arrangement 20 similar to that shown in Figure 1, including at least one separation element 45 and first and second filter channels 23, 24 extending between the first and second filter walls 21, 22 around at least one bend 30, 31. The above description applies equally to Figures 8A and 8B, and like reference numerals are used. However, rather than being between the channel section ends as in Figures 3, 4 and 6A-6F, at least one bend 30, 31 is located at and between the channel sides 50, 51 of the channel sections 35, 36, 37. As a result, fluid flow around the or each filter channel 23, 24 may extend over approximately 180 degrees around one axis around the at least one bend 30, 31. Thus, the fluid flow may change direction about two axes as it travels around the at least one bend 30, 31 between channel sections 35, 36, 37. In particular, the fluid flow may first change direction about 90 degrees about a first axis to reach the at least one bend 30, 31 at the channel side 50, 51. The fluid flow may then change direction about 180 degrees about a second axis, which may be perpendicular to the first axis and parallel to the main direction of fluid flow in the channel sections 35, 36, 37. Similar to Figures 8A and 8B, the or each filter channel 23, 24 may thus still extend between the first filter wall 21 and the second filter wall 22 around the first bend 30 and the second bend 31 so as to have a Z-shaped and / or serpentine path.
[0100] In particular, the first channel section 35 may extend between the first channel section ends, with the filter channel inlets 25, 26 located at the first channel section ends and the first bend 30 located at a side 51 of the first channel section (which may be adjacent to, but not around, the opposing first channel section ends). The second channel section 36 may extend between the second channel section ends, with the first bend 30 located at a side 51 of the second channel section (which may be adjacent to, but not around, the opposing second channel section ends), and the second bend 31 located at a side 50 of the opposing second channel section (which may be adjacent to, but not around, the opposing second channel section ends). The third channel section 37 may extend between the third channel section ends, with the second bend 31 located at a side 50 of the third channel section (which may be adjacent to, but not around, the opposing third channel section ends), and the filter channel outlet 27 located at the opposing third channel section ends.
[0101] 8A illustrates the folds required to form such an arrangement. Prior to folding, the channel sections 35, 36, 37 extend adjacent and parallel to one another. Channel section end welds, joints and / or heat seals 55 may be applied between the first filter wall 21 and the second filter wall 22 to form the separate channel sections 35, 36, 37. At least one filter channel 23, 24 may be folded back on itself at least once to form at least one bend 30, 31 between the channel section sides 50, 51 of the channel sections 35, 36, 37. In particular, the first channel section 35 and the second channel section 36 may be folded back on one another about the channel section side 51 to form the first bend 30. The second channel section 36 and the third channel section 37 may be folded back on one another about the channel section side 50 to form the second bend 31.
[0102] As shown in more detail in Figures 9A and 9B, the at least one separation element 45, 46 may comprise a mesh 45, 46. The mesh 45, 46 may be substantially rigid and / or incompressible to maintain the separation between the first filter wall 21 and the second filter wall 22, and may be sufficiently flexible to bend around at least one bend 30, 31. The mesh 45, 46 may have a plurality of weft threads 48 and warp threads 49, which may be regularly arranged with openings therebetween. The weft threads 48 and warp threads 49 may overlap each other as shown, may be connected, or may be a lattice of continuous thickness. In particular, the mesh 45, 46 may not be a nonwoven fabric, may not be a randomly woven material, may not be an open cell material, and may not be a foam.
[0103] The meshes 45, 46 may have at least one separation element channel 47 along the meshes 45, 46 for stoma gas to pass through the meshes 45, 46 to the filter channel outlet 27. The at least one separation element channel 47 may extend continuously along the entire mesh 45, 46 to provide a clear stoma gas path therethrough. The at least one separation element channel 47 may be formed between adjacent warp threads 49 or adjacent weft threads 48 of the meshes 45, 46 as shown, particularly when all the weft threads 48 overlap the warp threads 49 and vice versa. In particular, multiple separation element channels may be formed between multiple adjacent weft threads 48 as shown, where the weft threads 48 extend along at least one filter channel 23, 24. In this respect, the terms warp threads 49 and weft threads 48 are used interchangeably merely for nomenclature purposes.
[0104] 9B, the at least one separation element 45 may be separated from the channel sides 50, 51 by at least one separation element gap 52, 53. The at least one separation element gap 52, 53 may provide an additional path for stoma gas to travel along the at least one filter channel 23, 24.
[0105] The mesh 45, 46 may be at least about 10 mm wide, may be up to about 20 mm wide, and / or may be about 15 mm wide. The mesh 45, 46 may be at least about 60 mm long, may be up to about 100 mm long, and / or may be about 80 mm long. The mesh 45, 46 may extend from at least one filter channel inlet 25, 26 by at least about 1 mm, up to about 10 mm, and / or about 5 mm. At least one separation element gap 52, 53 may be at least about 1 mm wide (i.e., at least 1 mm between the mesh 45, 46 and the channel side 50, 51), may be up to about 5 mm wide, and / or may be up to about 3.5 mm wide.
[0106] The present disclosure further provides an ostomy device 10 and a filter arrangement 20, in which the filter arrangement 20 may include at least one separation element 45, preferably in the form of a mesh 45, 46, and may not include at least one filter channel 23, 24 extending between the first filter wall 21 and the second filter wall 22 around at least one bend 30, 31. Alternatively, the filter arrangement 20 may have a differently formed serpentine or Z-shaped path or may be without such a path. Figures 10A-12B show preferred embodiments according to the present disclosure. Similar features to those used in Figures 1-9B are illustrated with similar reference numerals.
[0107] 10A-10C show a filter arrangement 100 including a tortuous path between a first filter wall 21 and a second filter wall 22 without at least one bend 30, 31 and at least one separation element 45, 46, such as in the form of a mesh 45, 46. As shown, the filter arrangement 100 has a plurality of filter walls 101, 102, 103, 104 overlapping each other to form at least one filter channel 23, 24 having a plurality of channel sections 35, 36, 37 therebetween. The channel sections 35, 36, 37 are fluidly connected by at least one opening 105, 106 penetrating the filter walls 102, 103. Thus, stoma gas may travel from at least one filter channel inlet 25, 26 along at least one filter channel 23, 24, through the mesh 45, 46, through the opening(s) 105, 106, to the filter channel outlet 27.
[0108] The filter arrangement 100 may have a first channel section 35 formed between the first filter wall 101 and the second filter wall 102 and extending from at least one filter channel inlet 25, 26 to a first opening 105 in the second filter wall 102. The filter arrangement 100 may have a second channel section 36 formed between the second filter wall 102 and the third filter wall 103 and extending from the first opening 105 to a second opening 106 in the third filter wall 103. The filter arrangement 100 may have a third channel section 37 formed between the third filter wall 103 and the fourth filter wall 104 and extending from the second opening 106 to the filter channel outlet 27. The first, second, third and fourth filter walls 101, 102, 103, 104 may each be formed from separate layers of flexible sheet material and may be welded together at their sides 50, 51. The third filter wall 103 and the fourth filter wall 104 of each of the first filter channel 23 and the second filter channel 24 may be formed from the same layer of material, as shown in Figure 10A. The first filter wall 101 and the second filter wall 102 of each of the first filter channel 23 and the second filter channel 24, respectively, may be formed from different layers of material.
[0109] A separation element 45, 46 may be disposed in at least one, and preferably each, of the channel sections 35, 36, 37, or each separation element 45, 46 may be formed in any manner as described above, and preferably may be a mesh 45, 46. In particular, there may be at least one separation element channel 47 to provide a clear path for the passage of stoma gas along each of the first filter channel 23 and the second filter channel 24.
[0110] 11A and 11B show a further embodiment of a filter arrangement 110 in which at least one filter channel 23, 24 may only have a single channel section 111 and in which a separation element 112 extends through at least one filter channel 23, 24. In particular, each at least one filter channel 23, 24 extends from a filter channel inlet 25, 26 to a filter channel outlet 27 without passing through a bend. The separation element 112 may include a plastic, rigid, semi-rigid, hollow and / or injection molded housing 115, which may be attached to the first filter channel 23 and / or the second filter channel 24. The separation element 112 may be disposed between the first filter wall 21 and the second filter wall 22, as shown in FIG. 11B, and may preferably be heat sealed or welded. The housing 115 may be "n" shaped and may extend along both filter channels 23, 24 and across the filter channel outlet 27. The housing 115 may have a first housing inlet 116A and a second housing inlet 116B and a housing outlet 114. The housing 115 may have a first housing passageway 118A and a second housing passageway 118B leading from the first housing inlet 116A and the second housing inlet 116B, respectively, to the housing outlet 114.
[0111] The separation element 112 may have at least one mesh 113 located within the housing 115, preferably within the first housing passageway 118A and / or the second housing passageway 118B, e.g., by inserting therein or by molding therein. The at least one mesh 113 may have a woven fabric. The or each mesh 113 may extend along a portion of the housing 115 from the first housing inlet 116A and / or the second housing inlet 116B. The housing outlet 114 may be aligned with the filter channel outlet 27.
[0112] In use, stoma fluid may flow through filter channel inlet(s) 25, 26 and through first housing inlet 116A and second housing inlet 116B into housing 115. Stoma fluid may flow along first housing passageway 118A and / or second housing passageway 118B via mesh 113, thereby creating a tortuous path for the stoma fluid such that the flow of stoma liquid and stoma solids is impeded while stoma gas can flow therethrough. The stoma may flow through housing outlet 114 and out filter channel outlet 27 to gas vent 15.
[0113] 12A and 12B show a further embodiment of an ostomy appliance 120 according to the present disclosure having a filter arrangement 121 with a tortuous path. The filter arrangement 121 has a filter wall 122 attached to the outer wall 12 by attachment lines 123 which form at least one filter channel 124, 125, preferably a first filter channel 124 and a second filter channel 125, as shown. The attachment lines 123 may be formed by welding or any other suitable attachment method.
[0114] At least one filter channel 124, 125 may meander (i.e., around at least one bend) from a filter channel inlet 126 to a filter channel outlet 127 at the gas vent 15. At least one filter channel 124, 125 may extend between the filter wall 122 and the outer wall 12. At least one filter channel 124, 125 may have a plurality of filter channel sections 130, 131, 132, 133, 134 that may extend substantially parallel to each other and to the plane of the filter and outer wall 122, 12. They may extend substantially parallel to a centerline defined between the top and bottom of the ostomy appliance 120. The filter channel sections 130, 131, 132, 133, 134 may be partially separated from each other by the attachment line 123 and may be in fluid communication with each other by a gap 129 between the outer wall 12 and the filter wall 122. Thus, fluid flowing through at least one filter channel 124 , 125 may repeatedly meander upwards and downwards as it passes between filter channel inlet 126 and filter channel outlet 127 .
[0115] The filter arrangement 121 may have at least one separation element 135, which may be a mesh as shown, extending through at least one filter channel 124, 125. The filter arrangement 121 may have the separation element 135 extending across multiple filter channel sections 130, 131, 132, 133, 134 as shown. The attachment lines 123 may pass through the at least one separation element 135 so that they are also attached to the outer wall 12 and the filter wall 122. For example, the at least one separation element 135 may be fused to the outer wall 12 and the filter wall 122.
[0116] The ostomy appliance 10 may have a shielding wall 60 extending partially between the inner wall 11 and the outer wall 12 and positioned to extend across, overlap, align with and immediately adjacent to the stoma entrance 14. The shielding wall 60 may direct stoma output received from the stoma entrance 14 down the cavity 13 toward the cavity lower end 13b. The shielding wall 60 may have a substantially impermeable region 65 facing and completely overlapping the stoma entrance 14 such that the stoma output cannot pass directly through the shielding wall 60 after entering the cavity 13 via the stoma entrance 14. The surface area of the impermeable region 65 may completely cover the stoma entrance 14 and / or may be at least, preferably at least 110% of the area of the stoma entrance.
[0117] The shielding wall 60 may be disposed between the inner wall 11 and the filter arrangement 20 as shown. The shielding wall 60 may extend across the inner wall 11 and the outer wall 12 about the top half of the cavity 13. The shielding wall 60 may be substantially triangular in shape and thus have the same shape as the upper portions of the inner wall 11 and the outer wall 12. The sides of the shielding wall 60 may extend from the upper vertex 17a along the second side 18a and 18b toward the opposing side vertices 17c, 17d.
[0118] The shielding wall 60 may extend to a bottom side 64 spaced from the cavity bottom end 13b to allow stoma output to pass between the bottom side 64 and the cavity bottom end 13b. The bottom side 64 may be straight and may extend between the first side 118a and the second side 18b. The bottom side 64 may extend up to about 90% of the length between the cavity top end 13a and the cavity bottom end 13b, and may extend between about 25% to about 75% of the length of the inner wall 11 from the top, upper apex 17a and / or cavity top end 13a of the ostomy device 10.
[0119] The shielding wall 60 may be joined to the inner wall 11 and the outer wall 12 at or adjacent to a part or all of the first side 18a and the second side 18b thereof, preferably by bonding, welding, gluing or a similar means. The joining method is preferably welding, and the peripheral joint joining the inner wall 11 and the outer wall 12 to the shielding wall 60 may be the whole or a part of the peripheral joint 16 joining the inner wall 11 and the outer wall 12. As shown in FIG. 1, the peripheral joint 16 may extend around the entire circumference of the inner wall 11 and the outer wall 12, or may extend around the upper side of the shielding wall 60, i.e., the first side 18a and the second side 18b. The lower side 64 of the shielding wall 60 may be a free side and may be movable relative to the inner wall 11 and / or the outer wall 12.
[0120] The shielding wall 60, like at least one of the appliance walls 11, 12 and the first and second filter walls 21, 22, may comprise a flexible sheet material.
[0121] The shielding wall 60 may have at least one shielding wall opening 61, 62 penetrating therethrough. The at least one shielding wall opening 61, 62 may be disposed adjacent to the stoma entrance 14 so as not to overlap. The at least one shielding wall opening 61, 62 may preferably have a first shielding wall opening 61 and a second shielding wall opening 62 on opposite sides of the impermeable region 65 (i.e., toward opposite side vertices 17c, 17d). Also, each of the at least one shielding wall opening 61, 62 may be triangular as shown, and the hypotenuses of the first shielding wall opening 61 and the second shielding wall opening 62 may face each other as shown.
[0122] 13A-13C show an exemplary method for forming the ostomy appliance 10 illustrated in FIGS. 1-4. As in FIG. 13A, the inner wall 11 and the outer wall 12 may be formed from a flexible sheet material having a stoma entrance 14 and a gas vent 15. The shielding wall 60 may be formed from a flexible sheet material having a first shielding wall opening 61 and a second shielding wall opening 62 therethrough. The filter arrangement 20 may be disposed on and optionally attached to the outer wall 12. As in FIG. 13B, the shielding wall 60 may be positioned over and attached to the filter arrangement 20 and the outer wall 12. As in FIG. 13C, the inner wall 11 may be attached over the outer wall 12, the filter arrangement 20 and the shielding wall 60 and then bonded or welded thereto around the peripheral joint 16. A closure paper or coupling may then be attached over the stoma entrance 14. It will be appreciated that additional steps may occur if other elements, such as a separation wall, a drain or a filter, are also to be included in the ostomy appliance 10. It will further be appreciated that the shielding wall 60 may be attached to the inner wall 11 instead of or in addition to the outer wall 12.
[0123] 15A and 15B, the shielding wall 60 may have a spacer arrangement 66 for at least partially separating the shielding wall 60 from the inner wall 11 and / or the outer wall 12 such that a fluid path 68, preferably a gas path, is formed between the inner wall 11 and the shielding wall 60 and / or between the shielding wall 60 and the outer wall 12. The fluid path 68 may lead from the stoma inlet 14 to the lower edge 64 and / or from the lower edge 64 to at least one filter channel inlet 25, 26. Such a fluid path 68 may be formed by mounting the shielding wall 60 such that it is at least partially separated from the outer wall 12, particularly when in a flat configuration.
[0124] The spacer arrangement 66 may have at least one undulation 67 of the flexible sheet material of the shielding wall 60, as shown in Figures 15A and 15B. Thus, the shielding wall 60 may be attached to the inner wall 11 and / or the outer wall 12 such that they are at least partially not aligned parallel to each other. In particular, the at least one undulation 67 may be in the form of an area of excess flexible sheet material of the shielding wall 60 relative to the overlapping areas of the inner wall 11 and / or the outer wall 12. The area of excess flexible sheet material may thus form a space between the shielding wall 60 and the inner wall 11 and / or the outer wall 12, which may form a fluid path 68. The at least one undulation 67 may form a fluid path 68 extending adjacent the shielding wall 60 to at least one filter channel inlet 25, 26.
[0125] In particular, the shielding wall 60 may have flexible sheet material extending across a shielding wall area. The shielding wall area may be considered as the area within the perimeter of the shielding wall 60, and thus the area of at least one shielding wall opening 61, 62 is included in the shielding wall area. The shielding wall 60 may overlap the inner wall 11 and / or the outer wall 12 across the overlap area of the inner wall 11 and / or the outer wall 12. The shielding wall area may be larger than the overlap area such that at least one undulation 67 is formed by an area of excess flexible sheet material of the shielding wall 60 relative to the overlap area of the inner wall 11 and / or the outer wall 12. Thus, the footprint of the shielding wall 60 may be the same as the overlap area, but the shielding wall 60 may extend across an area larger than the overlap area.
[0126] The thickness of the flexible sheet material of the shielding wall 60 may be constant across at least one undulation 67. Thus, the spacer arrangement 66 may not include anything other than the flexible sheet material that forms the shielding wall 60.
[0127] 14A-14C illustrate a preferred method of attaching the shielding wall 60 to the inner and / or outer wall 12, whereby a fluid pathway 68 is formed therebetween, in particular allowing stoma gas to reach at least one filter channel inlet 25, 26. Preferably, as shown, at least one undulation 67 is formed during attachment of the shielding wall 60 to the inner and / or outer wall 11, 12.
[0128] Initially, the shielding wall 60 may be positioned over and at least partially attached to the inner wall 11 or the outer wall 12. Prior to attachment, the flexible sheet material of the shielding wall 60 may extend across a substantially flat plane before forming at least one rib 67. As in Figure 14A, the shielding wall 60 may be positioned over and at least partially attached to the outer wall 12, preferably along the first side 18a and the second side 18b.
[0129] At least one ripple 67 may then be formed in the shielding wall 60. Forming the at least one ripple 67 may include lifting at least a portion of the flexible sheet material of the shielding wall 60 off of a flat plane. For example, as in FIG. 14B, a central portion 80 of the shielding wall 60 may then be moved upward 81 relative to the exterior wall 12 by moving the contact point 82 upward. The central portion 80 may extend from the bottom edge 64 between the first shielding wall opening 61 and the second shielding wall opening 62, substantially corresponding to the impermeable region 65. As a result, an excess of material of the shielding wall 60 relative to the exterior wall 12 may be formed.
[0130] The shield wall 60 may then be attached to the inner wall 11 and / or the outer wall 12 to maintain the at least one undulation 67 of the shield wall 60. The excess of material may be permanently incorporated into the shield wall 60 by further bonding to the outer wall 12, for example, as in FIG. 14C. For example, at least one center joint 83 may be formed between the shield wall 60 and the outer wall 12 around the perimeter of the center portion 80, around the perimeter of the first and second shield wall openings 61 and 62, and / or along the bottom edge 64.
Claims
1. at least one appliance wall of a flexible sheet material forming a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, said at least one appliance wall having a stoma inlet for receiving said stoma output and a gas vent for allowing said stoma gas to travel outside of said cavity; A filter arrangement attached to the at least one appliance wall, comprising: at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, said at least one filter channel inlet being located within said cavity for receiving said stoma output from said cavity, said filter channel outlet being mounted in communication with said gas vent for allowing stoma gas to travel from said at least one filter channel to said gas vent; at least one separation element extending at least partially along the at least one filter channel for maintaining the at least one filter channel in an open configuration along at least a portion of the at least one filter channel to allow stoma gas to pass therethrough; a filter arrangement having Equipped with the filter arrangement having first and second filter walls of flexible sheet material forming the at least one filter channel; the at least one filter channel extends between the first filter wall and the second filter wall around at least one bend to restrict passage of stoma liquid and / or stoma solids along the at least one filter channel.
2. The at least one separation element comprises at least one mesh. The ostomy device of claim 1.
3. The mesh has a regular arrangement of weft and warp threads. The ostomy device of claim 2.
4. the at least one separation element having at least one separation element channel therealong for passing stoma gas through the at least one separation element to the filter channel outlet. The ostomy device according to any one of claims 1 to 3.
5. The at least one separation element channel is formed between adjacent warp threads or adjacent weft threads of the at least one mesh.
5. An ostomy device according to claim 4 when dependent on claim 2 or 3.
6. the at least one separation element extends around the at least one bend in the at least one filter channel. The ostomy device according to any one of claims 1 to 5.
7. the filter arrangement has overlapping filter walls to form the at least one filter channel, with channel sections formed between the filter walls, the channel sections fluidly connected by at least one opening through the filter walls. The ostomy device according to any one of claims 1 to 6.
8. the filter arrangement includes a first filter channel section formed between a first filter wall and a second filter wall and extending from the at least one filter channel inlet to a first opening in the second filter wall, and a second channel section formed between the second filter wall and the third filter wall and extending from the first opening to a second opening in the third filter wall.
8. The ostomy device of claim 7.
9. the at least one separation element comprises a hollow housing and at least one mesh disposed in the hollow housing and extending along at least a portion of the hollow housing; the hollow housing extends from at least one housing inlet to at least one housing outlet, the at least one housing outlet aligned with a filter channel outlet; The ostomy device according to any one of claims 1 to 6.
10. the at least one filter channel having a plurality of filter channel sections extending in a serpentine manner between a filter wall and the at least one instrument wall and partially separated from one another by an attachment line between the filter wall and the at least one instrument wall. The ostomy device according to any one of claims 1 to 6.
11. The at least one appliance wall has an inner wall and an outer wall, and further has a shielding wall extending partially between the inner wall and the outer wall and positioned to overlap the stoma entrance. The ostomy device according to any one of claims 1 to 10.
12. a selectively openable and closable drain for selectively allowing the stoma output to be evacuated from the cavity. An ostomy device according to any one of claims 1 to 11.
13. The cavity is sealed within the ostomy appliance other than through the gas vent and the stoma entrance. An ostomy device according to any one of claims 1 to 11.
14. Further comprising a seal paper non-releasably attached to the at least one appliance wall around the stoma opening, or further comprising a releasable coupling attached to the at least one appliance wall around the stoma opening and a seal paper attached to the releasable coupling. An ostomy device according to any one of claims 1 to 11.
15. forming at least one appliance wall from a flexible sheet material having a stoma entrance and a gas vent; forming a filter arrangement having first and second filter walls of a flexible sheet material forming at least one filter channel extending from at least one filter channel inlet to a filter channel outlet, and at least one separation element extending at least partially along the at least one filter channel to maintain the at least one filter channel in an open configuration along at least a portion of the at least one filter channel to allow the passage of stoma gas, wherein the at least one filter channel extends between the first and second filter walls around at least one bend; the at least one appliance wall defines a cavity for containing a stoma output having stoma gas and stoma liquid and / or stoma solids, the stoma inlet is arranged to receive the stoma output, and the gas vent is arranged to allow the stoma gas to travel out of the cavity; the at least one filter channel inlet is positioned in the cavity to receive the stoma output from the cavity, and the filter channel outlet is mounted in communication with the gas vent to allow stoma gas to travel from the at least one filter channel to the gas vent; the at least one bend is positioned to restrict passage of stoma liquid and / or stoma solids along the at least one filter channel. and attaching the filter arrangement and the at least one appliance wall to each other so that A method for manufacturing an ostomy appliance, comprising:
16. The at least one appliance wall includes an inner wall and an outer wall; The inner wall has the stoma entrance, The outer wall has the gas vent. The method of claim 15.
Citation Information
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