Ostomy appliances
By using flexible sheets, curved components and partition elements in ostomy instruments, the expansion and blockage problems caused by gas accumulation are solved, and the effective emission of ostomy gas and the stability of the instrument are improved.
Patent Information
- Application Number
- CN202180028910.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-04-15
- Filing Date
- 2021-04-14
- Publication Date
- 2024-12-20
- Estimated Expiration
- 2041-04-14
AI Technical Summary
During use, existing ostomy instruments are prone to expand due to gas accumulation, resulting in movement and leakage, and the filter is easily blocked, affecting the effective emission of ostomy output gas.
An ostomy instrument consisting of a flexible sheet is designed, equipped with a filter configuration, which prevents the stoma solids and liquid from entering the filter passage through the bending parts and the partitioning elements, ensuring that the gas can be discharged efficiently and through the gas. Filter elements reduce odor.
Effectively prevent the expansion and blockage of ostomy instruments, ensure the smooth emission of ostomy gas, reduce the risk of leakage caused by the movement of the instrument, and improve the stability and reliability of the instruments.
Smart Images

Figure CN115484901B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to an ostomy appliance for managing stoma effluent, and in particular to an ostomy appliance comprising a filter arrangement. The present invention also provides a method of manufacturing an ostomy appliance. Background Art
[0002] There are many attempts to provide ostomy appliances that are secure, reliable, and comfortable to wear for ostomates. However, stoma output gases may accumulate in the ostomy appliance, causing it to swell and increasing the likelihood that it will move from its original position during use. In addition to forming a visible bulge under the ostomate's clothing, any movement of the ostomy appliance may cause leakage or the appliance to fall off the ostomate. Therefore, ostomy appliances may include an outlet for allowing stoma output gases to escape from the ostomy appliance. An odor-absorbing gas filter may be used at the outlet. However, the outlet and / or the filter may become blocked, and thus swell of the ostomy appliance may still occur.
[0003] US-B-8298201 discloses a filter for ostomy appliances, comprising a passageway for directing gas to a vent in an ostomy bag and a protective element contained within the passageway to prevent blockage of the passageway by solid or semi-liquid waste. The passageway is defined by a liquid-impermeable layer and comprises a protective element of an open-pore, compressible material having a memory and a pore size of at least 60 PPI. The protective element extends in the same direction as the airflow within the passageway. The passageway has an opening that allows access to the passageway from the interior of the bag and another opening that is optionally connected to the vent on the ostomy bag via a deodorizing filter.
[0004] US-A-2003 / 0014023 discloses a body waste collector. US-B-5250042 discloses an ostomy bag with a filter assembly.
[0005] There remains a need for ostomy appliances with enhanced usability for ostomates, particularly in terms of improving the drainage of stoma output gases and reducing inflation of ostomy appliances due to stoma output gases. Summary of the Invention
[0006] In this specification, the term "stomal output" refers to any gas, liquid or solid produced by a stoma user that can be secreted from or leave the stoma. Stoma output may include stoma gas, stoma liquid and stoma solid.
[0007] As used herein, the term "stoma" refers to an opening in the body. Typically, a stoma is a surgical opening in the trunk of the body. In some cases, the term "stoma" also refers to internal tissue, an organ, or a portion thereof exposed by the opening. As non-limiting examples, the internal tissue can be selected from the group consisting of the colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue can be the end or loop of the small or large intestine.
[0008] In this specification, the term "ostomate" refers to a subject who can use the ostomy appliances disclosed herein. Although an ostomate is typically referred to as a subject with a surgical opening, as used herein, "ostomate" can refer to a subject with a stoma, whether created surgically or otherwise. The term "user" can refer to the ostomate, or another person who assists the ostomate, such as by emptying stoma output from a cavity.
[0009] In the present specification, the ostomy appliances disclosed herein can be used, for example, to manage a stoma created by an esophagostomy, gastrostomy, cholecystostomy, choledochostomy, cecostomy, colostomy, duodenostomy, ileostomy, jejunostomy, appendostomy, tracheostomy, urethrostomy, 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] In this specification, the position and orientation of features may be described with reference to the ostomy appliance "in use", "as it is oriented in use", or similar terms. These terms refer to the intended orientation of the ostomy appliance when the ostomy appliance is attached to the body of an ostomy user when the ostomy user is in a standing position, regardless of whether the ostomy appliance is currently being used in this manner or the actual position of the ostomy user. The terms "upper", "lower", "top", "bottom" and related terms refer to the relative position of a component or part of the ostomy appliance when it is oriented as it will be in use. For example, when the ostomy appliance is in use, the apex of the ostomy appliance may be referred to as the "upper" apex. In such an example, when attached to the body of a standing ostomy user, the apex would be intended to be the uppermost apex (in the vertical direction) of the ostomy appliance. However, those skilled in the art will understand that the apex may not always be the uppermost apex before attachment to the ostomy user, and further, when attached, the apex may not always be the uppermost apex if the ostomy user adopts a non-standing posture, such as lying down.
[0011] In this specification, the terms "interior / inner" and "exterior / outer" refer to the relative position of a component or portion of an ostomy appliance relative to the body of an ostomy user when the ostomy appliance is attached to the body. "Interior / inner" refers to a position closer to the body of an ostomy user than the relative position of "exterior / outer". "Exterior / outer" refers to a position further away from the body of an ostomy user than the relative position of "interior / inner". In this specification, the term "peripheral" refers to a portion located at or toward the edge of the referenced item.
[0012] The present disclosure provides an ostomy appliance comprising: at least one appliance wall constructed of a flexible sheet material, the at least one appliance wall forming a cavity for accommodating ostomy output comprising ostomy gas and ostomy liquid and / or ostomy solid, the at least one appliance wall comprising a stomy inlet for receiving the stomy output and an exhaust port for allowing ostomy gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising 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 inlet is located in the cavity for receiving ostomy output from the cavity, and the filter channel outlet is mounted to communicate with the exhaust port for allowing ostomy gas to migrate from the at least one filter channel to the exhaust port.
[0013] The present invention also provides a method of manufacturing an ostomy appliance, the method comprising: forming at least one appliance wall from a flexible sheet, the appliance wall comprising a stoma inlet and an exhaust outlet; forming a filter arrangement comprising at least one filter channel extending from at least one filter channel inlet to a filter channel outlet; and mounting the filter arrangement and at least one appliance wall to each other such that: the at least one appliance wall forms a cavity for accommodating stoma output comprising stoma gas and stoma liquid and / or stoma solid, the stoma inlet being arranged to receive the stoma output, and the exhaust outlet being arranged to allow stoma gas to migrate out of the cavity; and the at least one filter channel inlet being located in the cavity and arranged to receive the stoma output from the cavity, and the filter channel outlet being mounted to communicate with the exhaust outlet to allow stoma gas to migrate from the at least one filter channel to the exhaust outlet.
[0014] In use, stoma output can be received in the cavity through the stoma inlet. Stoma gas can migrate from the cavity to the at least one filter channel inlet, pass through the at least one filter channel, and migrate out of the ostomy appliance via the at least one filter channel outlet and the vent. Thus, the vent can allow stoma gas accumulated in the ostomy appliance to escape therefrom and prevent the ostomy appliance from bulging outward.
[0015] However, when an ostomy user moves around with the attached ostomy appliance, they may change the orientation of the ostomy appliance so that ostomy solids and / or ostomy liquids contact the at least one filter channel inlet (e.g., if the ostomy appliance is inverted or on its side while the ostomy user is lying down). In this case, some ostomy solids and / or ostomy liquids may enter the at least one filter channel through the at least one filter channel inlet.
[0016] The filter arrangement may comprise first and second filter walls of a flexible sheet material forming the at least one filter channel. The at least one filter channel extends between the first and second filter walls around at least one bend for restricting passage of stoma fluid and / or stoma solids along the at least one filter channel.
[0017] The at least one bend can restrict the flow of stoma solids and / or stoma liquids and / or can filter out stoma solids and / or stoma liquids to prevent them from reaching the filter channel outlet and preventing them from contacting the exhaust port. In particular, the at least one bend can create at least one twist point / pinch point / narrow point, and when stoma output reaches the at least one bend, it may be blocked by the stoma output. When stoma gas accumulates at the at least one bend due to the at least one twist point formed by the at least one bend, pressure can force the first and second filter walls to separate at the at least one twist point. As a result, stoma gas may be able to flow around the at least one bend, which thus acts as a self-regulating valve, while stoma solids and / or stoma liquids may not be able to cross the at least one bend. The exhaust port can therefore remain free of stoma liquid and / or stoma solids, and it does not become blocked, so that it can still effectively discharge stoma gas.
[0018] The at least one filter channel may extend along at least one channel section that extends 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 device wall. The filter channel may fold back around the at least one bend. Thus, the method of forming a filter configuration may include folding the at least one filter channel back at least once to form the at least one bend. This configuration may advantageously form an effective kink point to help restrict the flow of stoma solids and / or stoma liquids along the filter channel.
[0019] The at least one filter channel may extend between the first and second filter walls around first and second bends such that the at least one filter channel is Z-shaped.Using multiple bends may help to further restrict the passage of stoma liquids and / or stoma solids.
[0020] In use, the at least one filter channel inlet and / or filter channel outlet may be located above the center of the stoma inlet. The first bend may be located above the second bend and / or the filter channel inlet, and the second bend may be located below the filter channel outlet. As a result, gravity may help prevent some stoma fluid and / or stoma solids from migrating from the second bend toward 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 segment extending to the first bend and a second channel segment extending from the first bend. The first channel segment 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 from the first bend to the second bend along the second channel segment, and may include a third channel segment extending from the second bend. The third channel segment may extend from the second bend to the filter channel outlet.
[0022] The first or second filter wall may form the inner side of the at least one bend and may be formed by at least one flexible sheet material that overlaps around the at least one bend, or may be formed by a flexible sheet material that extends from the inner side of the at least one bend and extends away from the bend. The first or second filter wall may form the outer side of the at least one bend and may be formed by at least one flexible sheet material that overlaps around the at least one bend.
[0023] The first and second channel segments may extend between the channel segment ends and between the channel segment edges. The at least one filter channel inlet may be located at the channel segment end of the first channel segment. The at least one bend may be between the channel segment ends of the first and second channel segments, or the at least one bend may be between the channel segment edges of the first and second channel segments. The at least one filter channel may include first and second channel segments extending in series along a single axis prior to folding. The at least one filter channel may fold back on itself at least once to form the at least one bend between the channel segment ends of the first and second channel segments. Thus, in one embodiment, a method of manufacturing an ostomy appliance is provided, comprising: forming at least one appliance wall from a flexible sheet material, the appliance wall comprising a stoma inlet and an exhaust port; forming a filter arrangement comprising first and second filter walls constructed from the flexible sheet material, the first and second filter walls 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; and mounting the filter arrangement and the at least one appliance wall to each other such that: the at least one appliance wall forms a cavity for accommodating stoma output comprising stoma gas and stoma liquid and / or stoma solids, the stoma inlet being arranged to receive an ostomy gas or stoma liquid and / or stoma solids. the at least one filter channel inlet being located in the cavity and arranged to receive stoma output from the cavity, and the vent being arranged to allow stoma gas to migrate out of the cavity; the at least one filter channel inlet being located in the cavity and arranged to receive stoma output from the cavity, and the filter channel outlet being mounted to communicate with the vent to allow stoma gas to migrate from the at least one filter channel to the vent; and the at least one bend being arranged to restrict the passage of stoma liquid and / or stoma solids along the at least one filter channel, wherein the at least one filter channel comprises first and second channel segments extending in series along a single axis before folding, and wherein the at least one filter channel folds back on itself at least once to form the at least one bend between channel segment ends of the first and second channel segments.
[0024] The at least one filter channel may comprise first and second channel segments extending parallel to each other 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 channel segment edges of the first and second channel segments. Thus, in one embodiment, a method of manufacturing an ostomy appliance is provided, comprising: forming at least one appliance wall from a flexible sheet, the appliance wall comprising a stoma inlet and an exhaust outlet; forming a filter arrangement comprising first and second filter walls constructed from a flexible sheet, the first and second filter walls forming at least one filter channel extending from the at least one filter channel inlet to the filter channel outlet, wherein the at least one filter channel extends between the first and second filter walls around the at least one bend; and mounting the filter arrangement and the at least one appliance wall to each other such that: the at least one appliance wall forms a cavity for accommodating stoma output comprising stoma gas and stoma liquid and / or stoma solid, the stoma inlet The filter channel is arranged to receive stoma output, and the exhaust port is arranged to allow stoma gas to migrate out of the cavity; the at least one filter channel inlet is located in the cavity and is arranged to receive stoma output from the cavity, and the filter channel outlet is installed to communicate with the exhaust port to allow stoma gas to migrate from the at least one filter channel to the exhaust port; and the at least one bend is arranged to restrict the passage of stoma liquid and / or stoma solids along the at least one filter channel, wherein the at least one filter channel includes first and second channel segments extending parallel to each other before folding, and wherein the at least one filter channel is folded back on itself at least once to form the at least one bend between channel segment edges of the first and second channel segments.
[0025] The ostomy appliance may further comprise at least one gas filter element located proximate to the vent. The at least one gas filter element may be located in the at least one filter channel adjacent to the filter channel outlet. In use, the vent may be located in the upper portion of the ostomy appliance and may comprise at least one aperture in the at least one appliance wall.
[0026] The at least one appliance wall may include an inner wall and an outer wall. The inner wall and the outer wall may be joined together, 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, for example at least partially via the peripheral joint.
[0027] The filter arrangement may include first and second filter channels extending from first and second filter channel inlets to filter channel outlets, respectively. Each of the first and second filter channels may extend between the first and second filter walls around at least one bend, the at least one bend being configured to restrict passage of stoma fluid and / or stoma solids along the first and second filter channels. By having multiple filter channels, gas flow to the filter channel outlets may be increased, thereby further reducing bloating. The first and second filter channels may extend from the exhaust port substantially perpendicular to each other.
[0028] Thus, in one embodiment, there is provided an ostomy appliance comprising: at least one appliance wall constructed of a flexible sheet material, the at least one appliance wall forming a cavity for accommodating ostomy output comprising ostomy gas and ostomy liquid and / or ostomy solids, the at least one appliance wall comprising a stoma inlet for receiving the stomy output and an exhaust port for allowing the stomal gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising first and second filter walls constructed of a flexible sheet material, the first and second filter walls 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 inlet is located in the cavity for receiving the stomal output from the cavity, and the filter channel outlet being mounted in communication with the exhaust port for allowing stoma gas to migrate from the at least one filter channel to the exhaust port, wherein the at least one filter channel extends between first and second filter walls around at least one bend, the at least one bend being configured to restrict the passage of stoma liquid and / or stoma solids along the at least one filter channel, wherein the ostomy appliance further comprises first and second filter channels extending from first and second filter channel inlets to filter channel outlets, respectively, wherein: each of the first and second filter channels extends between first and second filter walls around at least one bend being configured to restrict the passage of stoma liquid and / or stoma solids along the first and second filter channels; and the first and second filter channels extend from the exhaust port substantially perpendicular to each other.
[0029] The filter arrangement may comprise at least one partition 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. In particular, the at least one partition 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 partition element may extend around at least one bend. Thus, the partition element prevents the first and second filter walls from adhering to each other and prevents the filter channel from adhering to itself and forming a restriction in the at least one filter channel.
[0030] The separator element may comprise a mesh. A mesh may be particularly suitable because it may provide a sufficiently complex path to block the passage of stoma liquids and stoma solids, but the at least one mesh channel may allow the flow of stoma gas. The mesh may be rigid. The mesh may comprise a regular array of weft and warp threads. The at least one separator element may comprise at least one separator element channel and / or the mesh may comprise at least one mesh channel extending along it for allowing stoma gas to pass through the at least one separator element or mesh to reach the filter channel outlet. The at least one separator element 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 separator element channel ensures that there is always a gas path leading to the filter channel outlet. Thus, in one embodiment, there is provided an ostomy appliance comprising: at least one appliance wall constructed of a flexible sheet material, the at least one appliance wall forming a cavity for accommodating ostomy output comprising ostomy gas and ostomy liquid and / or ostomy solids, the at least one appliance wall comprising a stoma inlet for receiving the ostomy output and an exhaust port for allowing the ostomy gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising: 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 inlet is located in the cavity for receiving the ostomy output from the cavity, and the filter channel outlet Installed to communicate with the exhaust port, for allowing stoma gas to migrate from the at least one filter channel to the exhaust port; and at least one partition element, which extends 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, wherein: the at least one partition element includes at least one mesh member; the at least one partition element includes at least one partition element channel along it, for allowing stoma gas to pass through the at least one partition element to reach the filter channel outlet; and the at least one partition element channel is formed between adjacent warp threads or adjacent weft threads of the at least one mesh member.
[0031] The filter arrangement may comprise at least one separating element in combination with the previous embodiment, wherein the filter arrangement comprises first and second filter walls of flexible sheet material forming the at least one filter channel, and wherein the 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.
[0032] Alternatively, the filter arrangement may comprise filter walls overlapping each other to form the at least one filter channel. A plurality of channel segments may be formed between the filter walls. The plurality of channel segments may be fluidically connected via at least one hole through the filter walls.
[0033] The at least one partitioning element may comprise a hollow shell and at least one mesh member located in and extending along at least a portion of the shell. The hollow shell may extend from at least one shell inlet to at least one shell outlet. The at least one shell outlet may be aligned with the filter channel outlet. The at least one shell inlet may be located adjacent to the at least one filter channel inlet. Therefore, in one embodiment, an ostomy appliance is provided comprising: at least one appliance wall constructed of a flexible sheet, the at least one appliance wall forming a cavity for accommodating ostomy output comprising ostomy gas and ostomy liquid and / or ostomy solid, the at least one appliance wall comprising a ostomy inlet for receiving the ostomy output and an exhaust port for allowing the ostomy gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising: at least one filter channel extending from the at least one filter channel inlet to the filter channel outlet, wherein the at least one filter channel inlet is located in the cavity for receiving the ostomy output from the cavity, and the filter a filter channel outlet mounted to communicate with the exhaust port for allowing stoma gas to migrate from the at least one filter channel to the exhaust port; and at least one partition 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, wherein the at least one partition element comprises a hollow shell and at least one mesh member positioned in and extending along at least a portion of the shell, wherein the hollow shell extends from at least one shell inlet to at least one shell outlet, the at least one shell outlet being aligned with the filter channel outlet.
[0034] The at least one filter channel may extend meanderingly between the filter wall and the at least one vessel wall and may comprise a plurality of filter channel segments which are partially separated from one another by attachment lines between the filter wall and the at least one vessel wall.
[0035] The ostomy appliance may further comprise a shield wall extending partially between the inner wall and the outer wall, the shield wall being arranged to overlap said stoma entrance.Thereby, the shield wall may deflect stoma output downwardly from the stoma entrance.
[0036] Thus, in one embodiment, there is provided an ostomy appliance comprising: at least one appliance wall constructed of a flexible sheet material, the at least one appliance wall forming a cavity for accommodating ostomy output comprising ostomy gas and ostomy liquid and / or ostomy solids, the at least one appliance wall comprising a stoma inlet for receiving the stomy output and an exhaust port for allowing the stoma gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising: 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 inlet is located within the cavity. The apparatus further comprises a filter channel configured to receive stoma output from the cavity, the filter channel outlet being mounted in communication with the exhaust port for allowing stoma gas to migrate from the at least one filter channel to the exhaust port; and at least one partition 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, wherein the at least one apparatus wall comprises an inner wall and an outer wall, and further comprises a shield wall extending partially between the inner wall and the outer wall and arranged to overlap the stoma inlet.
[0037] Furthermore, in an optional embodiment of the present invention, there is provided an ostomy appliance comprising: at least one appliance wall formed of a flexible sheet material, the at least one appliance wall forming a cavity for accommodating ostomy output comprising ostomy gas and ostomy liquid and / or ostomy solid, the at least one appliance wall comprising a stomy inlet for receiving the stomy output and an exhaust port for allowing the stomy gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising first and second filter walls formed of a flexible sheet material, the first and second filter walls 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 inlet is located in the cavity for receiving stoma output from the cavity, and the filter channel outlet is installed to communicate with the exhaust port for allowing stoma gas to migrate from the at least one filter channel to the exhaust port, wherein the at least one filter channel extends between first and second filter walls around at least one bend, the at least one bend being configured to restrict the passage of stoma liquid and / or stoma solids along the at least one filter channel, wherein the at least one appliance wall includes an inner wall and an outer wall, and further includes a shield wall extending partially between the inner wall and the outer wall and arranged to overlap the stoma inlet.
[0038] The shielding wall may be attached to the inner wall and / or the outer wall such that a gas path is formed between the shielding wall and the at least one filter channel inlet. Thus, in one embodiment of the present invention, there is provided an ostomy appliance comprising: at least one appliance wall constructed of a flexible sheet material, the at least one appliance wall forming a cavity for accommodating ostomy output comprising ostomy gas and ostomy liquid and / or ostomy solid, the at least one appliance wall comprising a stomy inlet for receiving the stomy output and an exhaust port for allowing the stomy gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising first and second filter walls constructed of a flexible sheet material, the first and second filter walls forming at least one filter channel extending from the at least one filter channel inlet to the filter channel outlet, wherein the at least one filter channel inlet is located in the cavity. , for receiving stoma output from the cavity, and the filter channel outlet is installed to communicate with the exhaust port for allowing stoma gas to migrate from the at least one filter channel to the exhaust port, wherein the at least one filter channel extends between the first and second filter walls around at least one bend, the at least one bend being used to restrict the passage of stoma liquid and / or stoma solids along the at least one filter channel, wherein: the at least one appliance wall includes an inner wall and an outer wall, and further includes a shield wall extending partially between the inner wall and the outer wall and arranged to overlap the stoma inlet; and the shield wall is attached to the inner wall and / or the outer wall so that a gas path is formed between the shield wall and the at least one filter channel inlet.
[0039] Therefore, the present invention provides an ostomy appliance comprising: an inner wall and an outer wall formed of a flexible sheet material, the inner wall and the outer wall forming a cavity for accommodating stoma output, the inner wall comprising a stoma inlet for receiving the stoma output; and a shielding wall formed of a flexible sheet material, the shielding wall extending between the inner wall and the outer wall across the stoma inlet and comprising a spacing arrangement for at least partially separating the shielding wall from the inner wall and / or from the outer wall to form a fluid path therebetween, the spacing arrangement comprising at least one corrugated portion of the flexible sheet material of the shielding wall.
[0040] The present invention also provides a method for manufacturing an ostomy appliance, comprising: attaching an inner wall and an outer wall composed of a flexible sheet material together to form a cavity for accommodating stomal output, the inner wall including a stomal entrance for receiving the stomal output; attaching a shielding wall composed of a flexible sheet material to the inner wall and / or the outer wall so that the shielding wall extends across the stomal entrance; and forming at least one corrugated portion in the flexible sheet material of the shielding wall to form a spacing configuration structure, which is used to at least partially separate the shielding wall from the inner wall and / or the outer wall to form a fluid path therebetween.
[0041] In this configuration, the outer wall may include a vent for allowing stoma gas of the stoma output to migrate out of the cavity, and wherein the fluid path allows stoma gas to reach the vent. The ostomy appliance may further include a filter arrangement mounted above the vent for allowing stoma gas to migrate out of the cavity, through the filter arrangement, and out of the ostomy appliance via the vent. The filter arrangement may be as disclosed herein. The at least one corrugated portion may form a fluid path extending adjacent to the shield wall to the at least one filter channel inlet. The shield wall may be attached to the filter arrangement and the inner wall and positioned between the filter arrangement and the inner wall.
[0042] The maintenance of the fluid path ensures that stoma gas can effectively flow through the stoma inlet, and between the shield wall and the inner wall, and between the shield wall and the outer wall, until it reaches the filter channel inlet. Therefore, the shield wall can prevent stoma output from passing through the stoma inlet and directly contacting any filter arrangement structure.
[0043] The shielding wall may comprise a flexible sheet extending across an area of the shielding wall. The shielding wall may overlap the inner wall and / or outer wall across an overlapping area of the inner wall and / or outer wall. The shielding wall area may be greater than the overlapping area. Thus, the at least one corrugated portion may be formed by an area of the shielding wall where the flexible sheet is in excess relative to the overlapping area of the inner wall and / or outer wall. As a result, the spacing arrangement may be formed solely from the flexible sheet. The thickness of the flexible sheet of the shielding wall may be constant across the entire at least one corrugated portion.
[0044] The shield wall may extend from the top of the ostomy appliance between the edges of the ostomy appliance. The shield wall may extend to a lower edge spaced apart from the lower end of the cavity such that stoma output may pass between the lower edge and the lower end of the cavity. The shield wall may extend from the top of the ostomy appliance between the edges of the ostomy appliance and may extend to a lower edge spaced apart from the lower end of the cavity such that stoma output may pass between the lower edge and the lower end of the cavity. The shield wall may include a substantially impermeable region opposite the stoma entrance and overlapping the entire stoma entrance.
[0045] The shield wall may include at least one shield wall hole therethrough, the at least one shield wall hole being located adjacent to and not overlapping the stoma entrance. The at least one shield wall hole may help prevent the formation of additional and unnecessary wrinkles in the shield wall that may otherwise impede the flow of stoma gas.
[0046] Prior to forming the at least one corrugated portion, the flexible sheet material of the shield wall may extend along a substantially flat plane. Forming the at least one corrugated portion may include moving at least a portion of the flexible sheet material of the shield wall out of the flat plane. Forming the at least one corrugated portion may occur during attachment of the shield wall to the inner and / or outer wall. Therefore, in one embodiment, a method for manufacturing an ostomy appliance is provided, comprising: attaching an inner wall and an outer wall composed of a flexible sheet together to form a cavity for accommodating stomal output, the inner wall comprising a stomal entrance for receiving the stomal output; attaching a shielding wall composed of a flexible sheet to the inner wall and / or the outer wall so that the shielding wall extends across the stomal entrance; and forming at least one corrugated portion in the flexible sheet of the shielding wall to form a spacing configuration structure, which is used to at least partially separate the shielding wall from the inner wall and / or the outer wall to form a fluid path between the shielding wall and the inner wall and / or the outer wall, wherein the method also includes forming the at least one corrugated portion during attaching the shielding wall to the inner wall and / or the outer wall.
[0047] The method may include positioning a shield wall above an inner wall or an outer wall. The method may include moving at least a portion of the shield wall relative to the inner wall or the outer wall to form the at least one corrugated portion. The method may include attaching the shield wall to the inner wall and / or the outer wall to retain the at least one corrugated portion in the shield wall. Therefore, in one embodiment, a method for manufacturing an ostomy appliance is provided, comprising: attaching an inner wall and an outer wall composed of a flexible sheet together to form a cavity for accommodating stomal output, the inner wall comprising a stomal entrance for receiving the stomal output; attaching a shielding wall composed of a flexible sheet to the inner wall and / or the outer wall so that the shielding wall extends across the stomal entrance; and forming at least one corrugated portion in the flexible sheet of the shielding wall to form a spacing configuration structure, which is used to at least partially separate the shielding wall from the inner wall and / or the outer wall to form a fluid path between the shielding wall and the inner wall and / or the outer wall, wherein the method further comprises: positioning the shielding wall above the inner wall or the outer wall; moving at least a portion of the shielding wall relative to the inner wall or the outer wall to form the at least one corrugated portion and attaching the shielding wall to the inner wall and / or the outer wall to maintain the at least one corrugated portion in the shielding wall.
[0048] After positioning the shield wall over the inner wall or outer wall, the shield wall may be partially attached to the inner wall or outer wall. Thus, in one embodiment, a method of manufacturing an ostomy appliance is provided, comprising: attaching together an inner wall and an outer wall comprised of a flexible sheet material to form a cavity for accommodating stoma output, the inner wall comprising a stoma entrance for receiving the stoma output; attaching the shield wall comprised of a flexible sheet material to the inner wall and / or the outer wall such that the shield wall extends across the stoma entrance; and forming at least one corrugated portion in the flexible sheet material of the shield wall to form a spacing arrangement for at least partially separating the shield wall from the inner wall and / or from the outer wall. To form a fluid path between the shielding wall and the inner wall and / or the outer wall, wherein the method further comprises: positioning the shielding wall above the inner wall or the outer wall; moving at least a portion of the shielding wall relative to the inner wall or the outer wall to form the at least one corrugated portion and attaching the shielding wall to the inner wall and / or the outer wall to maintain the at least one corrugated portion in the shielding wall, wherein after positioning the shielding wall above the inner wall or the outer wall, the shielding wall is partially attached to the inner wall or the outer wall.
[0049] Ostomy appliances can be closed appliances or open appliances. Closed appliances are not configured to discharge stoma output from the cavity. Therefore, closed appliances can generally be configured as disposable, disposable and non-reusable appliances. Therefore, in the ostomy appliance of the present invention, the cavity can be completely sealed within the ostomy appliance, isolated from the external environment, rather than being connected to the stoma inlet through a vent. Open appliances are configured to enable stoma output to be discharged from the cavity. Therefore, open appliances can be configured as reusable appliances so that it can be reused and emptied multiple times while attached to the body, although this is not required. In open appliances, stoma output can be discharged intermittently under the action of the ostomist, or can be discharged intermittently or continuously due to the cavity being fluidically connected to a drainage structure. Therefore, the ostomy appliance of the present invention may include a drainage structure that can be opened selectively to allow stoma output to be selectively discharged from the cavity.
[0050] Thus, in one embodiment, there is provided an ostomy appliance comprising: at least one appliance wall constructed of a flexible sheet material, the at least one appliance wall forming a cavity for accommodating ostomy output comprising ostomy gas and ostomy liquid and / or ostomy solids, the at least one appliance wall comprising a stoma inlet for receiving the stomy output and an exhaust port for allowing the stoma gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising: 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 inlet is located in the cavity for receiving ostomy output from the cavity. and the filter channel outlet is mounted to communicate with the exhaust port for allowing stoma gas to migrate from the at least one filter channel to the exhaust port; and at least one partition 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, wherein the ostomy appliance further comprises a drainage structure that can be selectively opened to allow stoma output to be selectively discharged from the cavity, or wherein the cavity is sealed within the ostomy appliance without the exhaust port and the stoma inlet.
[0051] Furthermore, in an alternative embodiment, an ostomy appliance is provided, comprising: at least one appliance wall constructed of a flexible sheet material, the at least one appliance wall forming a cavity for accommodating stomal output comprising stomal gas and stomal liquid and / or stomal solids, the at least one appliance wall comprising a stomal inlet for receiving the stomal output and an exhaust port for allowing the stomal gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising first and second filter walls constructed of a flexible sheet material, the first and second filter walls 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 inlet is a filter channel inlet. A filter channel inlet is located in the cavity for receiving stoma output from the cavity, and the filter channel outlet is installed to communicate with the exhaust port for allowing stoma gas to migrate from the at least one filter channel to the exhaust port, wherein the at least one filter channel extends around at least one bend between the first and second filter walls for restricting the passage of stoma liquid and / or stoma solids along the at least one filter channel, wherein the ostomy appliance further includes a drainage structure that can be selectively opened to allow stoma output to be selectively discharged from the cavity, or wherein the cavity is sealed within the ostomy appliance without the exhaust port and the stoma inlet.
[0052] An ostomy appliance may include a wafer for attaching it to an ostomate's body. The ostomy wafer may have an opening for the stoma, which can be cut to the desired size by the user before attachment. The ostomy wafer may include at least one adhesive layer on a body-facing side for adhering the ostomy wafer to the ostomate's body. A release liner may cover the body-facing side of the ostomy wafer and be removed by the user before application to the skin. The term "wafer" may be used interchangeably with the terms "adapter," "substrate," or "layered adhesive wafer."
[0053] The ostomy appliance may be a one-piece appliance and may include a sheet that is non-releasably attached to the inner wall around the stoma entrance, such that the ostomy sheet cannot be easily separated without risking damage to the appliance. The ostomy appliance may be a two-piece appliance and may include a sheet and a releasable coupler attached to the inner wall around the stoma entrance, the sheet being attached to the releasable coupler such that the coupler can be disengaged to separate the sheet from the rest of the ostomy appliance. The ostomy sheet and / or the releasable coupler may be located at least partially in an upper peripheral region of the ostomy appliance.
[0054] Thus, in one embodiment, there is provided an ostomy appliance comprising: at least one appliance wall constructed of a flexible sheet material, the at least one appliance wall forming a cavity for accommodating ostomy output comprising ostomy gas and ostomy liquid and / or ostomy solids, the at least one appliance wall comprising a stoma inlet for receiving the stomy output and an exhaust port for allowing the stomal gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising: 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 inlet is located in the cavity for receiving the stomal output from the cavity, and the a filter channel outlet mounted to communicate with the exhaust port for allowing stoma gas to migrate from the at least one filter channel to the exhaust port; and at least one partition 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, wherein the ostomy appliance further comprises a sheet non-releasably attached to the at least one appliance wall around the stoma entrance, or the ostomy appliance comprises a releasable connector attached to the at least one appliance wall around the stoma entrance and a sheet attached to the releasable connector.
[0055] Furthermore, in an alternative embodiment, an ostomy appliance is provided, comprising: at least one appliance wall constructed of a flexible sheet material, the at least one appliance wall forming a cavity for accommodating stomal output including stomal gas and stomal liquid and / or stomal solid, the at least one appliance wall comprising a stoma inlet for receiving the stomal output and an exhaust port for allowing the stoma gas to migrate out of the cavity; and a filter arrangement mounted to the at least one appliance wall, the filter arrangement comprising: 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 inlet is located in the cavity for receiving stomal output from the air. The ostomy appliance further comprises a stoma output of a cavity, and the filter channel outlet is mounted in communication with the exhaust port for allowing stoma gas to migrate from the at least one filter channel to the exhaust port, wherein the 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, wherein the ostomy appliance further comprises a sheet non-releasably attached to the at least one appliance wall around the stoma entrance, or the ostomy appliance comprises a releasable coupler attached to the at least one appliance wall around the stoma entrance and a sheet attached to the releasable coupler.
[0056] Described at least one utensil wall, inner wall, outer wall, first filter wall, second filter wall and / or shielding wall can be formed by identical or different flexible sheet materials, and can be formed by at least one deck this flexible sheet material.Flexible sheet material can comprise polyurethane, polyethylene (PE), polyvinylidene chloride (PVDC) and / or ethylene-vinyl acetate copolymer (EVA).Flexible sheet material can have the thickness of approximately 50 microns to approximately 150 microns, preferably approximately 75 microns to approximately 100 microns.Flexible sheet material can comprise single layer or multilayer laminated material. BRIEF DESCRIPTION OF THE DRAWINGS
[0057] One or more embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:
[0058] Figure 1 is a front view of one embodiment of an ostomy appliance according to the present invention;
[0059] Figure 2 yes Figure 1 A cross-sectional view of an ostomy appliance taken along section AA;
[0060] Figure 3 yes Figure 1 A cross-sectional view of an ostomy appliance along section BB, wherein the separating element of the filter arrangement is obscured;
[0061] Figure 4 yes Figure 1 A partial cross-sectional view of an ostomy appliance through section BB showing a separating element of a filter arrangement;
[0062] Figure 5 is a partial front view of another embodiment of an ostomy appliance according to the present invention, wherein the filter arrangement is separated from the peripheral weld of the ostomy appliance;
[0063] Figures 6A to 6F is a perspective view showing the formation of Figures 1 to 5 Steps for configuring the filter structure;
[0064] Figure 7A yes Figure 1 a cross-sectional view of an ostomy appliance along section BB showing another embodiment of a filter arrangement, wherein a separating element of the filter arrangement is obscured;
[0065] Figure 7B yes Figure 6A A perspective view of a filter arrangement with the separator element obscured;
[0066] Figure 8A and 8B is a perspective view showing the formation of Figures 1 to 5 An alternative to the filter configuration structure;
[0067] Figure 9A yes Figure 1 a perspective view of one embodiment of a dividing element of the illustrated ostomy appliance;
[0068] Figure 9B is along the partition element including FIG10, Figure 1 a cross-sectional view of a filter channel width of a filter arrangement of an ostomy appliance;
[0069] Figure 10A and 10B is a perspective view showing another embodiment of a filter arrangement according to the present invention in an exploded configuration and a formed configuration, respectively;
[0070] Figure 10C It passes through Figure 10B a cross-sectional view of section CC of the filter arrangement shown;
[0071] Figure 11A and 11B is a perspective view showing another embodiment of a filter arrangement according to the present invention in an exploded configuration and in a formed configuration, respectively;
[0072] Figure 12A is a plan view of another embodiment of an ostomy appliance according to the present invention;
[0073] Figure 12B yes Figure 11A A cross-sectional view of the ostomy appliance along section DD;
[0074] Figures 13A to 13C is a perspective view showing a structure including a shielding wall. Figure 1 Steps for ostomy appliances;
[0075] Figures 14A to 14C is a plan view showing the Figures 13A to 13C the step of attaching the shielding wall of the ostomy appliance to the outer wall of the ostomy appliance;
[0076] Figure 15A Yes Figure 14C a perspective view of the outer wall and shield wall attached together showing the spacing arrangement; and
[0077] Figure 15B The outer wall and the shield wall are attached together through Figure 14C A partial cross-sectional view of section EE of FIG, wherein for reference the position of the inner wall in the assembled ostomy appliance is shown in dotted lines. DETAILED DESCRIPTION
[0078] In the following description, the same reference numerals are used in different embodiments to represent the same or similar features. Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by readers in the field of the claimed subject matter. It should be understood that the foregoing summary of the present disclosure and the following embodiments are only exemplary and explanatory and do not limit any subject matter claimed.
[0079] The following description is directed to embodiments of the present disclosure. The description of the embodiments is not intended to encompass all possible embodiments of the present disclosure as claimed in the appended claims. Many modifications, improvements, and equivalents not explicitly described in the following embodiments may fall within the scope of the appended claims. Features described as part of one embodiment may be combined with features of one or more other embodiments unless the context clearly requires otherwise.
[0080] It should be understood that at least some of the drawings and descriptions of the present disclosure have been simplified to focus on elements relevant to a clear understanding of the present disclosure, while other elements that may be required that will be understood by those skilled in the art have been omitted for clarity. Since these elements are well known to those skilled in the art and since they may not necessarily contribute to a better understanding of the present disclosure, descriptions of these elements are not provided here.
[0081] In this specification, 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.
[0082] As used herein, ranges and amounts may be expressed as "about" a particular value or range. About also includes the exact amount. For example, "about 5 mm" means "about 5 mm" and also means "5 mm." In general, the term "about" includes amounts that are expected to be within the range of experimental error. The term "about" includes values that fall within the range of 10% less than the provided value to 10% greater than the provided value. For example, "about 50%" means "45% to 55%." Similarly, for example, "about 30" means "27 to 33."
[0083] Figures 1 to 4 One embodiment of an ostomy appliance 10 according to the present invention is shown. The ostomy appliance 10 may comprise a wafer and / or a coupling (not shown) and may be a one-piece or a two-piece appliance.
[0084] The ostomy appliance 10 may include at least one appliance wall 11, 12 formed from a flexible sheet material, the at least one appliance wall forming a cavity 13 for receiving stoma output. The at least one appliance wall 11, 12 may form the outer surface of the ostomy appliance 10 and may include an inner wall 11 and an outer wall 12 as shown. The cavity 13 is shown as having a single volume, but in alternative embodiments, it may be subdivided into two or more chambers by, for example, partitions, wall members, filter elements, etc.
[0085] The ostomy appliance 10 may have a substantially flat configuration before first use and before stoma output enters the cavity 13. In the flat configuration, the ostomy appliance 10 has a substantially flat planar shape, and the inner wall 11 and the outer wall 12 and any further partitions or components therebetween are substantially adjacent to each other.
[0086] The at least one appliance wall 11, 12, preferably the inner wall 11 as shown, may include a stoma inlet 14 for receiving stoma output from the stoma into the cavity 13. The stoma inlet 14 may be a hole extending through the inner wall 11. The at least one appliance wall 11, 12, preferably the outer wall 12 as shown, may include a vent 15 for allowing stoma gas to migrate out of the cavity 13. The vent 15 may include at least one hole extending through the outer wall 12.
[0087] In use, the stoma entrance 14 and the vent 15 may be located in the upper half of the ostomy appliance 10. In use, the center of the vent 15 may be located above the center of the stoma entrance 14. Preferably, in use, the entire periphery of the vent 15 is located above the entire periphery of the stoma entrance 14, as shown in FIG. Figure 1The term "above" is intended to mean that the vent 15 is located above the highest point of the stoma entrance 14 along a line parallel to the inner and outer walls 11, 12 when in the flat configuration, in use.
[0088] The diameter of the at least one hole of the vent 15 can be smaller than the diameter of the stoma entrance 14. The diameter of the at least one hole of the vent 15 can be at least about 1 mm, can be up to about 10 mm, and / or can be about 5 mm. The diameter of the stoma entrance 14 can be at least about 10 mm, can be up to about 60 mm, and / or can be about 45 mm. In use, the distance between the top of the ostomy appliance 10 and the center of the stoma entrance 14 can be at least about 40 mm, can be up to about 60 mm, and / or can be about 49 mm or about 50 mm.
[0089] The at least one appliance wall 11, 12 may be joined together to define a cavity 13 therebetween. The inner and outer walls 11, 12 may be joined together around their peripheral edges using a weld, adhesive, or equivalent mechanism such that a peripheral joint 16 may extend around the entire periphery of the inner and outer walls 11, 12 to form a fluid-tight seal therebetween. The peripheral joint 16 may have a width of 1 mm to 3 mm, preferably about 2 mm. In the embodiment shown, the ostomy appliance 10 is a closed appliance such that the cavity 13 is sealed within the ostomy appliance 10, rather than via / having a stoma inlet 14 and vent 15. In an alternative embodiment, it may be an open appliance and may include a drainage structure for allowing stoma output to flow out of the cavity 13.
[0090] The ostomy appliance 10, the inner wall 11, and the outer wall 12 can be generally quadrilateral as shown. In other embodiments, they can have any other suitable shape, such as a circle or an oval. The ostomy appliance 10, the inner wall 11, and the outer wall 12 can have a length of about 120 mm to about 200 mm, preferably about 140 mm to about 160 mm, such as about 145 mm, and can have a width of about 120 mm to about 200 mm, preferably about 140 mm to about 160 mm, such as about 140 mm or about 145 mm.
[0091] The inner wall 11 and the outer wall 12 may have one or more, preferably four, vertices 17a-d, wherein, as shown, at least one vertex is preferably rounded. The radius of curvature of each rounded vertex 17a-d may be about 30 mm. When in use (i.e., when worn by an ostomate), the inner wall 11 and the outer wall 12 may include an upper vertex 17a pointing substantially vertically upward, a lower vertex 17b pointing substantially vertically downward, and opposite side vertices 17c, 17d pointing substantially to each side, such as Figure 1. Upper vertex 17a may be connected to opposite side vertices 17c, 17d via first and second edges 18a, 18b, respectively. Lower vertex 17b may be connected to opposite side vertices 17c, 17d via third and fourth edges 18c, 18d, respectively. One or more of the first, second, third, and fourth edges 18a-d may be straight between their respective vertices 17a-d. In the event that vertices 17a-d are rounded, edges 18a-d may be straight between the rounded vertices 17a-d.
[0092] In use, the vent 15 may be located near the top of the ostomy appliance 10. As a result, the vent 15 may be located between the first and second edges 18a, 18b adjacent the upper apex 17a.
[0093] The cavity 13 can extend between an upper cavity end 13a adjacent the top of the ostomy appliance 10 and a lower cavity end 13b adjacent the bottom of the ostomy appliance 10. Thus, the upper cavity end 13a can be adjacent the upper apex 17a and the lower cavity end 13b can be adjacent the lower apex 17b. The vent 15 can be positioned adjacent the upper cavity end 13a.
[0094] The ostomy appliance 10 may comprise a filter arrangement 20 for allowing stoma gases to exit the cavity 13 via the vent 15 and for filtering out stoma solids and / or stoma liquids so as to prevent them from exiting the cavity 13 via the vent 15. The filter arrangement 20 may be mounted to the at least one appliance wall 11, 12, may be mounted to at least the outer wall 12 and / or may be mounted between the inner wall 11 and the outer wall 12. The filter arrangement 20 may be mounted above the vent 15.
[0095] exist Figures 2 to 4 In the drawings, the filter arrangement 20 is shown as being separated from the outer wall 12 for clarity, but may be in contact with and attached to the outer wall 12. Figure 1 As shown, the filter arrangement 20 may also extend into the peripheral joint 16 and may be attached to the inner wall 11 and the outer wall 12 via the peripheral joint 16 (for clarity this is omitted in the example). Figures 2 to 4 17a ). Thus, in use, the filter arrangement 20 may be located near the top of the ostomy appliance 10 and may extend along the edges of the inner wall 11 and the outer wall 12. Thus, the filter arrangement 20 may be located between the first and second edges 18a, 18b adjacent the upper apex 17a.
[0096] Alternatively, as Figure 5As shown, the filter arrangement 20 can be separated from the peripheral joint 16 and thus can be separated from the edges, preferably the first and second edges 18a, 18b. The filter arrangement 20 can be welded to the outer wall 12 independently of the peripheral joint 16 and can be welded adjacent to the peripheral joint 16. As a result, the thickness of the peripheral joint 16 can be reduced, thereby improving manufacturability and flexibility.
[0097] like Figure 3 、 4 As shown in Figures 6A to 6F, the filter arrangement 20 may include first and second filter walls 21, 22 formed of a flexible sheet material. The first and second filter walls 21, 22 may define at least one filter channel 23, 24 therebetween, the filter channel extending 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 the main planes of the flexible sheet material of the first and second filter walls 21, 22.
[0098] The first and second filter walls 21, 22 may comprise at least one strip of flexible sheet material joined together along at least one channel edge 50, 51, preferably a first and a second channel edge 50, 51, and the at least one filter channel 23, 24 may extend along the at least one channel edge 50, 51 between the planes of the flexible sheet material. Figure 3 、 4 As shown in Figures 6A to 6F, the first and second filter walls 21, 22 may each comprise a single continuous layer or strip of flexible sheet material forming the at least one filter channel 23, 24.
[0099] The at least one filter channel inlet 25, 26 may be used to receive stoma output from the cavity 13 and may therefore be located in the cavity 13. If the cavity 13 is divided into a plurality of chambers, the at least one filter channel inlet 25, 26 is preferably located in at least the chamber into which stoma gas may migrate.
[0100] The at least one filter channel outlet 27 can be mounted in communication with the exhaust port 15 and can be used to allow stoma gas to migrate from the at least one filter channel 23, 24 to the exhaust port 15. The filter channel outlet 27 can be located adjacent to and aligned with the exhaust port 15 so that stoma gas can pass from the filter channel outlet 27 through the exhaust port 15 into the external environment surrounding the ostomy appliance 10. The filter channel outlet 27 can be positioned through the first or second filter wall 21, 22 and, as shown, can include a hole therethrough. The first or second filter wall 21, 22 including the filter channel outlet 27 can be mounted above the exhaust port 15 around the exhaust port 15 so that the filter channel outlet 27 covers the exhaust port 15, for example, by attaching the first or second filter wall 21, 22 to the outer wall 12.
[0101] like Figure 1 and 6A 6F , the at least one filter channel 23, 24 may include first and second filter channels 23, 24 extending from first and second filter channel inlets 25, 26 to a filter channel outlet 27, respectively. The first and second filter channels 23, 24 may extend from the exhaust port 15 in different directions and may extend from the exhaust port 15 substantially perpendicular to each other, as shown. As a result, the first and second filter channels 23, 24 may extend from the exhaust port 15 parallel to and along the first and second edges 18a, 18b.
[0102] The at least one filter channel 23, 24 may extend between the first and second filter walls 21, 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 and / or second filter channels 23, 24.
[0103] The at least one bent portion 30 is arranged in Figure 3 and Figure 4 As shown in detail, Figure 3 and Figure 4 At least one bend 30, 31 of the first filter channel 23 is shown. The following description generally refers to the first filter channel 23, but it should be understood that the at least one bend 30, 31 of the second filter channel 24 (if any) may include the same features. The same reference numerals are used in the drawings to indicate corresponding features of each of the first and second filter channels 23, 24.
[0104] The or each filter channel 23, 24 may fold back on itself around the at least one bend 30, 31. The or each filter channel 23, 24 (and the flow along it) may extend into the at least one bend 30, 31 in a first direction and out of the at least one bend 30, 31 in an opposite, second direction. Thus, the or each filter channel 23, 24 may extend parallel to the inner and outer walls 11, 12 between the inner and outer walls 11, 12, fold back around the at least one bend 30, 31, and then continue to extend parallel to the inner and outer walls 11, 12 between the inner and outer walls 11, 12.
[0105] The or each filter channel 23, 24 may extend along at least one channel section 35, 36, 37, which extends to and / or from the at least one bend 30, 31 and preferably between the first and second filter walls 21, 22. When in the flat configuration, in the at least one channel section 35, 36, 37, the first and second filter walls 21, 22 are substantially parallel to the at least one vessel wall 11, 12, in particular the inner wall 11 and the outer wall 12.
[0106] The at least one channel section 35, 36, 37 may include 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 corresponding filter channel inlet 25, 26 to the first bend 30. Although not shown, if the at least one bend 30, 31 includes only the first bend 30, the second channel section 36 may extend from the first bend 30 to the filter channel outlet 27.
[0107] As in the illustrated embodiment, the or each filter channel 23, 24 may extend between the first and second filter walls 21, 22 around first and second bends 30, 31, such that the or each filter channel 23, 24 is Z-shaped and / or has a tortuous path. Thus, the second channel segment 36 extends between the first and second bends 30, 31, and the at least one channel segment 35, 36, 37 includes a third channel segment 37 extending between the second bend 31 and the filter channel outlet 27.
[0108] The first channel segment 35, the second channel segment 36, and, if present, the third channel segment 37 may extend between channel segment ends, may be elongated between channel segment ends, and may extend between channel segment edges 50, 51. Figure 3 、 4In the embodiments of filters 6A to 6F, the at least one bend 30, 31 is located between the ends of the channel segments. As a result, fluid flow around the or each filter channel 23, 24 extends approximately 180 degrees around the at least one bend 30, 31 about a single axis. Thus, as the fluid flow travels around the at least one bend 30, 31 between the channel segments 35, 36, 37, the fluid flow changes direction only about a single axis.
[0109] Specifically, the first channel segment 35 may extend between first channel segment ends, with the filter channel inlets 25, 26 located at one first channel segment end and the first bend 30 located at the opposite first channel segment end. The second channel segment 36 may extend between second channel segment ends, with the first bend 30 located at one second channel segment end and the second bend 31 or filter channel outlet 27 located at the opposite second channel segment end. The third channel segment 37 may extend between third channel segment ends, with the second bend 31 located at one third channel segment end and the filter channel outlet 27 located at the opposite third channel segment end.
[0110] The length along the filter channel 23,24 from respective filter channel inlet 25,26 to the filter channel outlet 27 can be at least about 70mm, can be up to about 120mm and / or can be about 95mm. The width of the filter channel 23,24 can be at least about 15mm, can be up to about 30mm and / or can be about 22mm. The first channel section 35 can be at least about 5mm long, can be up to about 15mm long and / or can be about 10mm long. The second channel section 36 can be at least about 30mm long, can be up to about 40mm long and / or can be about 35mm long. The third channel section 37 can be at least about 30mm long, can be up to about 70mm long and / or can be about 50mm long.
[0111] Each of the inner and outer sides of each bend 30, 31 may be formed by one of the first and second filter walls 21, 22. Figure 3 and 4 As shown, the first or second filter wall 21, 22 can be formed by a flexible sheet layer that is overlapped / bent upon itself around the inside or outside of at least one bend 30, 31. Thus, the inside of each bend 30, 31 can be formed by forming the first filter wall 21 (e.g. Figure 3 The first bend 30 in the filter) or the second filter wall 22 (such as Figure 3 The second curved portion 31 in the figure is formed by two layers of flexible sheets.
[0112] The ostomy appliance 10 may further include at least one gas filter element 40 located near the exhaust port 15. The at least one gas filter element 40 may be located in the at least one filter channel 23, 24 adjacent to and covering 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 located between the filter channel outlet 27 and the exhaust port 15, or may be mounted above the exhaust port 15 on the exterior side of the outer wall 12. In the latter case, the exhaust port 15 may further include a filter cap (not shown) located above the at least one gas filter element 40. The at least one gas filter element 40 may be an odor filter, such as a charcoal or activated carbon filter, to reduce odor from the exhausted stoma gas. The at least one gas filter element 40 may be a disk-shaped member, which may be circular, as shown. The diameter of the at least one gas filter element 40 may be at least about 10 mm, up to about 20 mm, and / or may be about 15 mm.
[0113] like Figure 4 As shown, the filter arrangement 20 may further comprise at least one separating element 45, 46, which extends at least partially along the at least one filter channel 23, 24 and which may be used to separate the first and second filter walls 21, 22 from one another along at least a portion of the at least one filter channel 23, 24. The at least one separating element 45, 46 is not provided in the filter arrangement. Figure 3 、 7A 7B to ensure that the first filter channel 23 is clearly visible.
[0114] The at least one partition element 45, 46 may substantially / substantially obstruct or prevent stoma liquid and / or stoma solids from traveling along the at least one filter channel 23, 24. The at least one partition element 45, 46 may allow stoma gas to travel along the at least one filter channel 23, 24 and may include at least one partition element channel 47 for allowing such passage of stoma gas (see Figure 8A ). The filter arrangement 20 may comprise first and second separation elements 45 , 46 located in each of the first and second filter channels 23 , 24 , respectively.
[0115] The or each partition element 45, 46 may extend around at least one bend 30, 31 and may extend at least between the first and second bends 30, 31, i.e., along at least the second channel section 36. As shown, the or each partition element 45, 46 may extend beyond the at least one filter channel inlet 25, 26. The or each partition element 45, 46 may extend along at least approximately 50%, at least approximately 75%, or at least approximately 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 partition element 45, 46 may extend from the respective filter channel inlet 25, 26 and around the at least one bend 30, 31, preferably around both the first and second bends 30, 31, and toward the filter channel outlet 27.
[0116] Figures 6A to 6F Shown for forming Figure 1 、 2 4 and 5, the filter arrangement 20 comprising at least one partition element 45 and first and second filter channels 23, 24 extending between first and second filter walls 21, 22 around first and second bends 30, 31. Initially, as Figure 6A As shown, the first and second filter walls 21, 22 can be cut from a flexible sheet in the form of V-shaped strips, the first and second partition elements 45, 46 can be formed as elongated strips, and the at least one gas filter element 40 can be provided. The filter channel outlet 27 can be formed by cutting a hole in the first filter wall 21. Figure 6B As shown, the first and second partition elements 45, 46 may be positioned on (and optionally attached to) the first filter wall 21, and the at least one gas filter element 40 may be mounted above the filter channel outlet 27. Figure 6C As shown, the second filter wall 22 can be located above the first filter wall 21, the first and second separation elements 45, 46 and the at least one gas filter element 40. At least one filter channel joint or weld 70 can then be applied along the first and second channel edges 50, 51 to connect the first and second filter walls 21, 22. Before folding, the at least one filter channel 23, 24 and its channel segments 35, 36, 37 extend along a single axis and / or extend in series / sequentially. Figure 6D and 6EAs shown, the first and second filter channels 23, 24 may be folded back upon themselves to form first and second bends 30, 31 in each of the first and second filter channels 23, 24, and such that the first and second bends 30, 31 are located at and between the channel segment ends. Figure 6F As shown, additional filter channel ties or welds 71 may then be applied along the first and second channel edges 50, 51 to retain the filter arrangement 20 in its Z-shape.
[0117] 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 also fall within the scope of the present disclosure. In alternative embodiments, they may instead comprise multiple layers or strips positioned adjacent to each other along the at least one filter channel 23, 24. Figure 7A and 7B An embodiment is shown in which the first and second filter walls 21, 22 are not formed from a continuous strip of flexible sheet material. The inner side of at least one bend 30, 31 may include a single layer of flexible sheet material forming one of the first and second filter walls 21, 22. This single layer may extend from the inner side of the at least one bend 30, 31 in a direction away from the bend without folding back on itself. The outer side of the at least one bend 30, 31 may include a layer of flexible sheet material folded back on itself. For example, Figure 7A and 7B As shown, first filter wall 21 may comprise one strip of flexible sheet material, and second filter wall 22 may comprise two strips of flexible sheet material. The inside of first bend 30 and the outside of second bend 31 may comprise the strip of first filter wall 21. The outside of first bend 30 may be formed by one strip of second filter wall 22, while the inside of second bend 31 may be formed by another strip of second filter wall 22.
[0118] Figure 8A and 8B Shows something like Figure 1 Another arrangement of the filter arrangement 20 is shown, comprising the at least one separating element 45 and the 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 also applies to Figure 8A and 8B , and identical reference numerals are used. However, the at least one bend 30, 31 is located at and between the channel edges 50, 51 of the channel sections 35, 36, 37, rather than Figure 3 、 4and 6A to 6F are located between the ends of the channel segments. As a result, the fluid flow around the or each filter channel 23, 24 can extend about 180 degrees around at least one bend 30, 31 about a single axis. Therefore, as the fluid flow travels around at least one bend 30, 31 between the channel segments 35, 36, 37, the fluid flow can change direction about two axes. In particular, the fluid flow may initially change direction by about 90 degrees about a first axis in order to reach the at least one bend 30, 31 at the channel edge 50, 51. The fluid flow may then change direction by about 180 degrees about a second axis, which second axis may be perpendicular to the first axis and parallel to the main direction of fluid flow in the channel segments 35, 36, 37. As Figure 8A and 8B As shown, the or each filter channel 23, 24 may therefore still extend between the first and second filter walls 21, 22 around the first and second bends 30, 31 so that the or each filter channel 23, 24 is Z-shaped and / or has a tortuous path.
[0119] Specifically, the first channel segment 35 may extend between first channel segment ends, with the filter channel inlets 25, 26 located at a first channel segment end, and the first bend 30 located at a first channel segment edge 51 (which may be adjacent to, but not surrounding, the opposite first channel segment end). The second channel segment 36 may extend between second channel segment ends, with the first bend 30 located at a second channel segment edge 51 (which may be adjacent to, but not surrounding, the second channel segment end), and the second bend 31 may be located at an opposite second channel edge 50 (which may be adjacent to, but not surrounding, the opposite second channel segment end). The third channel segment 37 may extend between third channel segment ends, with the second bend 31 located at a third channel segment edge 50 (which may be adjacent to, but not surrounding, a third channel segment end), and the filter channel outlet 27 located at the opposite third channel segment end.
[0120] Figure 8A The folding required to form this arrangement is shown. Prior to folding, the channel segments 35, 36, 37 extend adjacent to and parallel to one another. A channel segment edge weld, joint, and / or heat seal 55 can be applied between the first and second filter walls 21, 22 to form the separated channel segments 35, 36, 37. The at least one filter channel 23, 24 can be folded back on itself at least once to form the at least one bend 30, 31 between the channel segment edges 50, 51 of the channel segments 35, 36, 37. In particular, the first and second channel segments 35, 36 can be folded together around the channel segment edge 51 to form the first bend 30. The second and third channel segments 36, 37 can be folded together around the channel segment edge 50 to form the second bend 31.
[0121] like Figure 9A and 9B In further detail shown in, described at least one separating element 45,46 may comprise mesh 45,46.Mesh 45,46 can be fully hard and / or incompressible basically, to keep the separation between the first and second filter walls 21,22, and can be fully flexible so that it can bend around described at least one bend 30,31.Mesh 45,46 may comprise many wefts 48 and warp 49, and these wefts 48 and warp 49 can be arranged in a regular array, and can comprise opening therebetween.As shown in the figure, weft 48 and warp 49 can overlap each other, can be interconnected or can be the grid form with continuous thickness.Especially, mesh 45,46 may not be nonwoven material, may not be irregular woven material, may not be open-cell material, and may not be foam.
[0122] The mesh 45, 46 may include at least one separator element channel 47 along it for stoma gas to pass through the mesh 45, 46 to reach the filter channel outlet 27. The at least one separator element channel 47 may extend continuously along the entire mesh 45, 46 to provide a smooth stoma gas path therethrough. As shown, the at least one separator element channel 47 may be formed between adjacent warps 49 or adjacent wefts 48 of the mesh 45, 46 (particularly if the wefts 48 all overlie the warps 49, or vice versa). In particular, as shown, multiple separator element channels may be formed between multiple adjacent wefts 48 that extend along at least one filter channel 23, 24. In this regard, the terms "warp" 49 and "weft" 48 are used for nomenclature only and are interchangeable.
[0123] like Figure 9B As shown, the at least one partition element 45 may be spaced apart from the channel edges 50, 51 by at least one partition element gap 52, 53. The at least one partition element gap 52, 53 may provide an additional path for stoma gas to travel along the at least one filter channel 23, 24.
[0124] The mesh members 45, 46 can be at least about 10 mm wide, up to about 20 mm wide, and / or can be about 15 mm wide. The mesh members 45, 46 can be at least about 60 mm long, up to about 100 mm long, and / or can be about 80 mm long. The mesh members 45, 46 can extend at least about 1 mm, up to about 10 mm, and / or about 5 mm from the at least one filter channel inlet 25, 26. The at least one separator element gap 52, 53 can be at least about 1 mm wide (i.e., at least 1 mm between the mesh members 45, 46 and the channel edges 50, 51), up to about 5 mm wide, and / or can be about 3.5 mm wide.
[0125] The present disclosure also provides an ostomy appliance 10 and a filter arrangement 20, wherein the filter arrangement 20 may include the at least one separation element 45, which is preferably in the form of a mesh 45, 46, and the filter arrangement may not include at least one filter channel 23, 24 extending between the first and second filter walls 21, 22 around at least one bend 30, 31. Instead, the filter arrangement 20 may include a tortuous or Z-shaped path formed in a different manner, or may be devoid of such a path. Figures 10A to 12B A suitable embodiment according to the present invention is shown. Similar features are used in conjunction with Figures 1 to 9B Like reference numerals are used in the drawings.
[0126] Figures 10A to 10C A filter arrangement 100 is shown, comprising a tortuous path without at least one bend 30, 31 between first and second filter walls 21, 22, and at least one separator element 45, 46, for example in the form of a mesh 45, 46. As shown, the filter arrangement 100 comprises a plurality of filter walls 101, 102, 103, 104 stacked one on top of another to form the at least one filter channel 23, 24, with a plurality of channel segments 35, 36, 37 therebetween. The channel segments 35, 36, 37 are fluidically connected via at least one aperture 105, 106 extending through the filter walls 102, 103. Thus, stoma gas can travel via at least one filter channel inlet 25, 26 to a filter channel outlet 27 by traveling along the at least one filter channel 23, 24, through the mesh 45, 46, and through the apertures 105, 106.
[0127] The filter arrangement 100 may include 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 hole 105 in the second filter wall 102. The filter arrangement 100 may include a second channel section 36 formed between the second filter wall 102 and the third filter wall 103 and extending from the first hole 105 to a second hole 106 in the third filter wall 103. The filter arrangement 100 may include a third channel section 37 formed between the third filter wall 103 and the fourth filter wall 104 and extending from the second hole 106 to the filter channel outlet 27. The first, second, third and fourth filter walls 101, 102, 103, 104 may each be formed from a separate layer of flexible sheet material and may be welded together at their edges 50, 51. As shown in FIG. Figure 10AAs shown, the third and fourth filter walls 103, 104 of each of the first and second filter channels 23, 24 may be formed from the same layer of material.The first and second filter walls 101, 102 of each of the first and second filter channels 23, 24 may each be formed from different layers of material.
[0128] A partitioning element 45, 46 may be located in at least one, and preferably each, channel section 35, 36, 37. The or each partitioning element 45, 46 may be formed in any manner as described above, and is preferably a mesh 45, 46. In particular, it may include at least one partitioning element channel 47 for providing a clear path for stoma gas to pass along each of the first and second filter channels 23, 24.
[0129] Figure 11A and 11B Another embodiment of a filter arrangement 110 is shown, wherein the at least one filter channel 23, 24 may comprise only a single channel section 111, and wherein a partition element 112 extends through the at least one filter channel 23, 24. In particular, each of the 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 partition element 112 may comprise a housing 115, which may be plastic, rigid, semi-rigid, hollow and / or injection-molded, and which may be mounted in the first and / or second filter channel 23, 24. Figure 11B As shown, the partition element 112 can be positioned (preferably heat sealed or welded) between the first and second filter walls 21, 22. The housing 115 can be "n" shaped and can extend along both the filter channels 23, 24 and can extend across the filter channel outlet 27. The housing 115 can include first and second housing inlets 116A, 116B and a housing outlet 114. The housing 115 can include first and second housing passages 118A, 118B leading from the first and second housing inlets 116A, 116B to the housing outlet 114, respectively.
[0130] The partition element 112 may include at least one mesh 113 positioned within the housing 115, for example, by being inserted into the housing or molded therein, and preferably positioned within the first and / or second housing passageways 118A, 118B. The at least one mesh 113 may comprise a textile. The or each mesh 113 may extend from the first and / or second housing inlet 116A, 116B along a portion of the housing 115. The housing outlet 114 may be aligned with the filter channel outlet 27.
[0131] In use, stoma fluid can flow into the housing 115 through the filter channel inlets 25, 26 and through the first and second housing inlets 116A, 116B. The stoma fluid can flow along the first and / or second housing passages 118A, 118B via the mesh 113, which can form a tortuous path for the stoma fluid, thereby hindering the flow of stoma liquids and stoma solids while allowing stoma gas to flow therethrough. The stoma gas can flow through the housing outlet 114 and out of the filter channel outlet 27 to the exhaust port 15.
[0132] Figure 12A and 12B Another embodiment of an ostomy appliance 120 according to the present invention is shown, comprising a filter arrangement 121 having a tortuous path. The filter arrangement 121 may comprise a filter wall 122 attached to the outer wall 12 by an attachment line 123, the attachment line 123 forming at least one filter channel 124, 125, preferably first and second filter channels 124, 125 as shown. The attachment line 123 may be formed by welding or any other suitable attachment method.
[0133] The at least one filter channel 124, 125 can extend zigzag (i.e., around at least one bend) from a filter channel inlet 126 to a filter channel outlet 127 at the exhaust port 15. The at least one filter channel 124, 125 can extend between the filter wall 122 and the outer wall 12. The at least one filter channel 124, 125 can include a plurality of filter channel segments 130, 131, 132, 133, 134 that can extend substantially parallel to each other and to the planes of the filter wall 122 and the outer wall 12. They can extend substantially parallel to a centerline defined between the top and bottom of the ostomy appliance 120. The filter channel segments 130, 131, 132, 133, 134 can be partially separated from each other by the attachment line 123 and can be in fluid communication with each other by a gap 129 between the outer wall 12 and the filter wall 122. Therefore, the fluid flowing through the at least one filter channel 124 , 125 may meander upward and downward repeatedly while passing between the filter channel inlet 126 and the filter channel outlet 127 .
[0134] The filter arrangement 121 may include at least one separator element 135, which may be a mesh as shown, extending through the at least one filter channel 124, 125. As shown, the filter arrangement 121 may include a separator element 135 extending across a plurality of filter channel segments 130, 131, 132, 133, 134. The attachment line 123 may pass through the at least one separator element 135 so that it is also attached to the outer wall 12 and the filter wall 122. For example, the at least one separator element 135 may be welded to the outer wall 12 and the filter wall 122.
[0135] The ostomy appliance 10 may include a shield wall 60 that partially extends between the inner wall 11 and the outer wall 12 and is arranged to extend across, overlap / cover, align with, and be immediately adjacent to / directly adjacent to the stoma entrance 14. The shield wall 60 may direct stoma output received from the stoma entrance 14 downward into the cavity 13 and toward the cavity lower end 13b. The shield wall 60 may include a substantially impermeable region 65 that is opposite and completely covers the stoma entrance 14, such that stoma output cannot directly pass through the shield wall 60 after entering the cavity 13 through the stoma entrance 14. The surface area of the impermeable region 65 may completely cover the area of the stoma entrance 14 and / or the surface area of the impermeable region 65 may be at least equal to the area of the stoma entrance 14, preferably at least 110% of the area of the stoma entrance 14.
[0136] As shown, the shield wall 60 can be located between the inner wall 11 and the filter arrangement 20. The shield wall 60 can extend across approximately the upper half of the cavity 13, the inner wall 11, and the outer wall 12. The shield wall 60 can be substantially triangular, thus having the same shape as the upper portions of the inner wall 11 and the outer wall 12. The edges of the shield wall 60 can extend from the upper vertex 17a along the first and second edges 18a, 18b to the opposing side vertices 17c, 17d.
[0137] The shield wall 60 can extend to a lower edge 64 that is separate from the cavity lower end 13b, such that stoma output can pass between the lower edge 64 and the cavity lower end 13b. The lower edge 64 can be straight and can extend between the first and second edges 18a, 18b. The lower edge 64 can extend from the top, upper apex 17a, and / or cavity upper end 13a of the ostomy appliance 10 up to about 90% of the length between the cavity upper end 13a and the cavity lower end 13b, and can extend up to about 25% to about 75% of the length of the inner wall 11.
[0138] The shield wall 60 may be joined to the inner wall 11 and the outer wall 12 at or near a portion or all of the first and second edges 18a, 18b of the inner wall 11 and the outer wall 12, preferably by using bonding, welding, adhesives or equivalent means. Welding is a preferred joining method, and the peripheral joining portion joining the inner wall 11 and the outer wall 12 and the shield wall 60 may be all or a portion of the peripheral joining portion 16 joining the inner wall 11 and the outer wall 12. Figure 1 As shown, the peripheral joint 16 can extend around the entire periphery of the inner wall 11 and the outer wall 12, and can extend around the top edge, i.e., the first and second edges 18a, 18b of the shield wall 60. The lower edge 64 of the shield wall 60 can be a free edge and can move relative to the inner wall 11 and / or the outer wall 12.
[0139] The shield wall 60 may comprise a flexible sheet material in a similar manner to the at least one vessel wall 11 , 12 and the first and second filter walls 21 , 22 .
[0140] The shield wall 60 may include at least one shield wall aperture 61, 62 extending therethrough. The at least one shield wall aperture 61, 62 may be located adjacent to and not cover the stoma entrance 14. The at least one shield wall aperture 61, 62 preferably includes first and second shield wall apertures 61, 62 on opposite sides of the impermeable region 65 (i.e., toward opposite side vertices 17c, 17d). The shield wall aperture 61, 62, or each of the at least one shield wall aperture 61, 62, may be triangular in shape as shown, and the hypotenuse of each of the first and second shield wall apertures 61, 62 may face each other, as shown.
[0141] Figures 13A to 13C Shown for forming Figures 1 to 4 An exemplary method of using the ostomy appliance 10 is shown. Figure 13A As shown, the inner wall 11 and the outer wall 12 may be formed from a flexible sheet material with a stoma inlet 14 and an exhaust port 15 therein. The shield wall 60 may be formed from a flexible sheet material with first and second shield wall apertures 61, 62 therethrough. The filter arrangement 20 may be located on the outer wall 12 and may be optionally attached to the outer wall 12. Figure 13B As shown, the shield wall 60 may be positioned above and attached to the filter arrangement 20 and the outer wall 12. Figure 13CAs shown, the inner wall 11 can be mounted over the outer wall 12, the filter arrangement 20, and the shield wall 60 and then joined or welded thereto around the peripheral joint 16. Subsequently, the tab or coupler can be mounted over the stoma entrance 14. It should be understood that additional steps may occur if other elements, such as a dividing wall, a drainage structure, or a filter, are included in the ostomy appliance 10. Furthermore, it should be understood that the shield wall 60 can be attached to the inner wall 11 instead of or in addition to being attached to the outer wall 12.
[0142] like Figure 15A and 15B As shown, the shielding wall 60 may include a spacing arrangement 66 for at least partially separating the shielding wall 60 from the inner wall 11 and / or the outer wall 12, thereby forming a fluid path 68, preferably a gas path, 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 the at least one filter channel inlet 25, 26. Such a fluid path 68 may be formed by attaching the shielding wall 60 such that it is at least partially separated from the outer wall 12, particularly when in the flat configuration.
[0143] like Figure 15A and 15B As shown, the spacing arrangement 66 may include at least one corrugated portion 67 of the flexible sheet material of the shielding wall 60. Thus, the shielding wall 60 can be mounted to the inner wall 11 and / or the outer wall 12 so that they are at least partially not aligned parallel to each other. In particular, the at least one corrugated portion 67 may be in the form of an area of excess flexible sheet material of the shielding wall 60 relative to the overlapping area of the inner wall 11 and / or the outer wall 12. Thus, the area of excess flexible sheet material may be formed in a space between the shielding wall 60 and the inner wall 11 and / or the outer wall 12, and this space may form a fluid path 68. The at least one corrugated portion 67 may form a fluid path 68 extending adjacent to the shielding wall 60 to the at least one filter channel inlet 25, 26.
[0144] In particular, the shielding wall 60 may include a flexible sheet extending across a shielding wall area. The shielding wall area may be considered to be an area of the shielding wall 60 that is within the periphery of the shielding wall 60; thus, the area of the at least one shielding wall aperture 61, 62 is contained within the shielding wall area. The shielding wall 60 may overlap the inner wall 11 and / or outer wall 12 across an overlapping area of the inner wall 11 and / or outer wall 12. The shielding wall area may be larger than the overlapping area, such that the at least one corrugated portion 67 is formed by an area of the shielding wall 60 where the flexible sheet is in excess relative to the overlapping area of the inner wall 11 and / or outer wall 12. Thus, the footprint of the shielding wall 60 may be the same as the overlapping area, but the extended area of the shielding wall 60 may be larger than the overlapping area.
[0145] The thickness of the flexible sheet material of the shield wall 60 may be constant across the at least one corrugated portion 67. Thus, the spacing arrangement 66 may not include anything other than the flexible sheet material forming the shield wall 60.
[0146] Figures 14A to 14C A preferred method of attaching the shield wall 60 to the inner and / or outer wall 12 is shown, such that a fluid path 68 is formed therebetween, in particular such that stoma gas can reach the at least one filter channel inlet 25, 26. Preferably, as shown, the at least one corrugated portion 67 is formed during the attachment of the shield wall 60 to the inner and / or outer wall 11, 12.
[0147] Initially, the shield wall 60 may be located above the inner wall 11 or the outer wall 12 and may be at least partially attached to the inner wall 11 or the outer wall 12. Prior to attachment, the flexible sheet of the shield wall 60 may extend across a substantially flat plane prior to forming the at least one corrugated portion 67. Figure 14A As shown, the shield wall 60 may be positioned above the outer wall 12 and may be partially attached to the outer wall 12 , preferably along the first and second edges 18 a , 18 b .
[0148] Subsequently, at least one corrugated portion 67 may be formed in the shield wall 60. Forming the at least one corrugated portion 67 may include bringing at least a portion of the flexible sheet of the shield wall 60 out of the flat plane. Figure 14B As shown, by moving the contact point 82 upward, the central portion 80 of the shield wall 60 can be moved upward 81 relative to the outer wall 12. The central portion 80 can extend from the lower edge 64 between the first and second shield wall apertures 61, 62 and can substantially correspond to the impermeable area 65. As a result, an excess of material of the shield wall 60 relative to the outer wall 12 can be formed.
[0149] Subsequently, the shielding wall 60 may be attached to the inner wall 11 and / or the outer wall 12 to maintain the at least one corrugated portion 67 in the shielding wall 60. For example, Figure 14C As shown, the excess material can be permanently incorporated into the shield wall 60 by further joining the shield wall 60 to the outer wall 12. For example, at least one central portion joint 83 can be formed between the shield portion 60 and the outer wall 12 around the central portion 80, around the first and second shield wall apertures 61, 62, and / or along the lower edge 64.
Claims
1. An ostomy appliance, include: at least one appliance wall constructed of a flexible sheet material, the at least one appliance wall forming a cavity for receiving stoma output including 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 vent for allowing stoma gas to migrate out of the cavity; as well as A filter arrangement mounted to said at least one appliance wall, the filter arrangement comprising: 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 inlet is located in the cavity for receiving stoma output from the cavity, and the filter channel outlet is mounted in communication with the exhaust port for allowing stoma gas to migrate from the at least one filter channel to the exhaust port; and at least one partition 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, wherein the at least one partition element comprises at least one mesh, and the at least one partition element comprises at least one partition element channel therethrough for allowing stoma gas to pass through the at least one partition element to the filter channel outlet, Wherein, the at least one partition element channel is formed between adjacent warp threads or adjacent weft threads of the at least one mesh member.
2. The ostomy appliance according to claim 1, in, The mesh comprises a regular array of weft and warp threads.
3. The ostomy appliance according to claim 1 or 2, in, The at least one separation element extends around at least one bend of the at least one filter channel.
4. The ostomy appliance according to claim 1 or 2, in, The filter arrangement comprises first and second filter walls formed of a flexible sheet material, the first and second filter walls forming the at least one filter channel, wherein the 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.
5. The ostomy appliance according to claim 1 or 2, in, The filter arrangement comprises filter walls overlapping each other to form the at least one filter channel, a plurality of channel segments being formed between the filter walls, wherein the plurality of channel segments are fluidly connected by at least one hole extending through the filter walls.
6. The ostomy appliance according to claim 5, in, The filter configuration structure includes: a first channel section formed between the first filter wall and the second filter wall, the first channel section extending from the at least one filter channel inlet to a first hole in the second filter wall; and A second channel section is formed between the second filter wall and the third filter wall, the second channel section extending from the first hole to a second hole in the third filter wall.
7. The ostomy appliance according to claim 1 or 2, in, The at least one partition element includes a hollow shell and at least one mesh member located in the shell and extending along at least a portion of the shell, wherein the hollow shell extends from at least one shell inlet to at least one shell outlet, and the at least one shell outlet is aligned with the filter channel outlet.
8. The ostomy appliance according to claim 1 or 2, in, The at least one filter channel extends in a meandering manner between the filter wall and the at least one vessel wall and comprises a plurality of filter channel segments which are partially separated from one another by attachment lines between the filter wall and the at least one vessel wall.
9. The ostomy appliance according to claim 1 or 2, in, The at least one appliance wall comprises an inner wall and an outer wall, and further comprises a shield wall extending partially between the inner wall and the outer wall and arranged to overlap the stoma entrance.
10. The ostomy appliance according to claim 1 or 2, further comprising a selectively openable drainage structure for allowing stoma output to be selectively discharged from the cavity.
11. The ostomy appliance according to claim 1 or 2, further comprising a thin sheet non-releasably attached to the at least one appliance wall around the stoma entrance, or the ostomy appliance comprises a releasable connector attached to the at least one appliance wall around the stoma entrance and a thin sheet attached to the releasable connector.
12. A method of manufacturing an ostomy appliance, include: forming at least one appliance wall from a flexible sheet, the appliance wall comprising a stoma inlet and a vent; forming a filter arrangement comprising at least one filter channel extending from at least one filter channel inlet to a filter channel outlet and at least one partition 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; as well as The filter arrangement and at least one appliance wall are mounted to each other such that: the at least one appliance wall forming a cavity for receiving stoma output including stoma gas and stoma liquid and / or stoma solid, the stoma inlet being arranged to receive the stoma output, and the exhaust port being arranged to allow stoma gas to migrate out of the cavity; and the at least one filter channel inlet being located in the cavity and arranged to receive stoma output from the cavity, the filter channel outlet being mounted to communicate with the exhaust port to allow stoma gas to migrate from the at least one filter channel to the exhaust port, wherein the at least one partition element comprises at least one mesh member, and the at least one partition element comprises at least one partition element channel therethrough for allowing stoma gas to pass through the at least one partition element to the filter channel outlet, Wherein, the at least one partition element channel is formed between adjacent warp threads or adjacent weft threads of the at least one mesh member.
13. The method according to claim 12, in, The at least one appliance wall comprises an inner wall comprising a stoma inlet and an outer wall comprising a vent.
