# US 12,594,181 B2 · Ostomy appliance > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,594,181 B2 - Document ID: US12594181B2 - Status: Granted - Kind: B2 - Application number: 17/062,063 - Filed: 2020-10-02 - Published: 2021-04-08 - Granted: 2026-04-07 - Earliest claimed: 2019-10-04 - Assignees: Convatec Limited - Applicants: Convatec Limited - Inventors: Marcus Hoggarth; Oliver Poyntz; Kimahni Emsley; Daljinder Sanghera - Web page: https://patentgrep.com/patent/US12594181B2 ## CPC - A61F 5/441: having {venting or} deodorant means, e.g. filters {; having antiseptic means, e.g. bacterial barriers} - A61F 5/4404: {Details or parts} - A61F 5/4405: {Valves or valve arrangements specially adapted therefor (A61F5/441 takes precedence); Fluid inlets or outlets (A61F5/4407 takes precedence)} - A61F 5/445: Colostomy, {ileostomy or urethrostomy} devices (A61F5/441, A61F5/442, A61F5/443 take precedence) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract An ostomy appliance that has inner and outer walls of flexible sheet material. The inner wall has a stomal inlet and the outer wall has a gas vent. A separation wall is between the inner and outer walls forming separate first and second chambers and has a liquid and gas permeable separation filter. In use the first chamber is arranged to receive stomal output directed into the ostomy appliance via the stomal inlet. The separation filter is arranged to communicate, from the stomal output in the first chamber, stomal liquid and stomal gas to the second chamber. The gas vent is arranged to allow the stomal gas to migrate from the second chamber to outside of the ostomy appliance. ## Claims ### Claim 1 An ostomy appliance comprising: inner and outer walls of flexible sheet material, the inner wall comprising a stomal inlet and the outer wall comprising a gas vent; a separation wall between the inner and outer walls forming separate first and second chambers and comprising a liquid and gas permeable separation filter, the separation filter at least partially extending across a lower half of the ostomy appliance; a protective structure located within the second chamber and comprising a protective panel attached to the outer wall and forming a protective chamber around the gas vent, the protective panel comprising an impervious flexible sheet; and a protective chamber gas inlet comprises at least one through-hole or cut-out located in the protective panel for allowing the stomal gas to migrate from the second chamber into the protective chamber and a protective chamber liquid outlet formed between the protective panel and at least one wall to which the protective panel is attached for allowing the stoma liquid to migrate out of the protective chamber, where the protective chamber liquid outlet is located along a lower edge of the protective chamber, below the gas vent, and is formed within an attachment region between the protective panel and the outer sheet, such that any stoma liquid in the protective chamber is directed to migrate out of the protective chamber via the liquid outlet, and wherein, in use: the first chamber is arranged to receive stomal output directed into the ostomy appliance via the stomal inlet; the separation filter is arranged to communicate, from the stomal output in the first chamber, stoma liquid and stomal gas to the second chamber; and the gas vent is arranged to allow the stomal gas to migrate from the second chamber through the protective chamber to outside of the ostomy appliance. ### Claim 2 (depends on 1) The ostomy appliance as claimed in claim 1 wherein the separation filter comprises an array of wall apertures. ### Claim 3 (depends on 2) The ostomy appliance as claimed in claim 2 wherein the maximum diameter of each wall aperture is in the range of from about 0.03 mm to about 0.8 mm inclusive; wherein the spacing between adjacent wall apertures in the array is in the range of from about 0.8 mm to about 2.2 mm; wherein the array of wall apertures have an entirely stochastic distribution. ### Claim 4 (depends on 1) The ostomy appliance as claimed in claim 1 wherein the separation filter extends across at least 50%, at least 75% or at least 90% of the surface area of the separation wall and wherein the separation wall extends across at least 50%, at least 75% or all of the surface area of the inner and/or outer walls. ### Claim 5 (depends on 1) The ostomy appliance as claimed in claim 1 wherein the separation filter extends between: the lower half or lower quarter of the separation wall and/or inner and outer walls; and the upper half or upper quarter of the separation wall and/or inner and outer walls. ### Claim 6 (depends on 1) The ostomy appliance as claimed in claim 1 wherein the first and second chambers are sealed from one another other than via the separation filter. ### Claim 7 (depends on 1) The ostomy appliance as claimed in claim 1 wherein the separation wall at least partially extends across a lower half or lower quarter of the ostomy appliance. ### Claim 8 (depends on 1) The ostomy appliance as claimed in claim 1 wherein the separation wall comprises a non-perforated area at least partially surrounded by the separation filter and aligned with the stomal inlet. ### Claim 9 (depends on 1) The ostomy appliance as claimed in claim 1 wherein the separation wall is attached to the inner wall by at least one first attachment region arranged to hold the separation wall to the inner wall when the ostomy appliance is inflated such that an open volume is created between the separation wall and outer wall. ### Claim 10 (depends on 1) The ostomy appliance as claimed in claim 1 further comprising a retractable drain and the separation wall extends at least partially into the retractable drain, wherein the retractable drain is configurable in: a retracted position in which the first and second chambers are sealed from one another, other than via the separation filter, by the retractable drain such that the stomal output, stomal liquid and stomal gas are prevented from exiting the first and second chambers via the retractable drain and the stomal liquid and stomal gas can only be communicated from the first chamber to the second chamber via the separation filter; and an extended position in which the stomal output, stomal liquid and stomal gas are able to exit the first and second chambers via the retractable drain. ### Claim 11 (depends on 1) The ostomy appliance as claimed in claim 1 wherein the separation wall comprises one or more pleats configured to partially or fully unfold as the first chamber receives the stomal output. ### Claim 12 (depends on 11) The ostomy appliance according to claim 11 wherein the one or more pleats is configured to partially or fully unfold as the cavity receives the stomal output to promote displacement of a first lateral region and a second lateral region of the ostomy appliance towards the body of the ostomate. ### Claim 13 (depends on 12) The ostomy appliance according to claim 12 wherein the first lateral region, and the second lateral region are two opposed lateral regions and the conformation of the inner wall produces an improved conformation of the inner wall to a torso of the ostomate. ### Claim 14 (depends on 11) The ostomy appliance according to claim 11 wherein each pleat comprises a generally Z-shaped form having two distinct folds. ### Claim 15 (depends on 11) The ostomy appliance according to claim 11 wherein the one or more pleats comprise two pleats which are arranged symmetrically about a vertical midline of the outer wall and aligned with fold lines of the inner wall and/or the outer wall. ### Claim 16 (depends on 1) The ostomy appliance according to claim 1 wherein the protective chamber gas inlet and the protective chamber liquid outlet are located below the gas vent and the at least one through-hole or cut-out comprises a plurality of panel apertures in the protective panel. ### Claim 17 A method of manufacturing an ostomy appliance comprising: inner and outer walls of flexible sheet material, the inner wall comprising a stomal inlet and the outer wall comprising a gas vent; a separation wall between the inner and outer walls forming separate first and second chambers and comprising a liquid and gas permeable separation filter, the separation filter at least partially extending across a lower half of the ostomy appliance; and a protective structure located within the second chamber and comprising a protective panel attached to the outer wall and forming a protective chamber around the gas vent, the protective panel comprising an impervious flexible sheet; and a protective chamber gas inlet comprises at least one through-hole or cut-out located in the protective panel for allowing the stomal gas to migrate from the second chamber into the protective chamber and a protective chamber liquid outlet formed between the protective panel and at least one wall to which the protective panel is attached for allowing the stoma liquid to migrate out of the protective chamber, where the protective chamber liquid outlet is located along a lower edge of the protective chamber, below the gas vent, and is formed within an attachment region between the protective panel and the outer sheet, such that any stoma liquid in the protective chamber is directed to migrate out of the protective chamber via the liquid outlet, and wherein, in use: the first chamber is arranged to receive stomal output directed into the ostomy appliance via the stomal inlet; the separation filter is arranged to communicate, from the stomal output in the first chamber, stoma liquid and stomal gas to the second chamber; and the gas vent is arranged to allow the stomal gas to migrate from the second chamber through the protective chamber to outside of the ostomy appliance; the method comprising laying the inner and outer walls over one another with the separation wall and protective panel therebetween and attaching the inner, outer and separation walls to one another. ### Claim 18 (depends on 16) The ostomy appliance according to claim 16 wherein the protective chamber gas inlet and protective chamber liquid outlet are spaced apart in a range of about 10 mm to about 20 mm, and the protective chamber liquid outlet and a centre of the gas vent are spaced apart in the range of about 25 mm to about 40 mm. ### Claim 19 (depends on 1) The ostomy appliance as claimed in claim 1 wherein the protective panel comprises a substantially triangular shape. ### Claim 20 (depends on 19) The ostomy appliance according to claim 19 wherein the protective panel extends from a top of the ostomy appliance between first and second edges of the ostomy appliance, and the protective panel extends across at least 25% and/or across less than 50% of a surface area of the outer wall.