# US 2018/0021164 A1 · Mounting assemblies for ostomy appliances comprising an adhesive skin barrier member having a multi-petaled outer perimeter > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2018/0021164 A1 - Document ID: US20180021164A1 - Status: Published application - Kind: A1 - Application number: 15/548,294 - Filed: 2016-12-09 - Published: 2018-01-25 - Earliest claimed: 2016-05-12 - Assignees: Marlen Manufacturing and Development Co. - Applicants: Marlen Manufacturing and Development Co. - Inventors: Gary H. Fenton - Web page: https://patentgrep.com/patent/US20180021164A1 ## CPC - A61F 5/443: having {adhesive seals for securing to the body, e.g. of} hydrocolloid type seals, e.g. gels, starches or karaya gums - A61F 5/445: Colostomy, {ileostomy or urethrostomy} devices (A61F5/441, A61F5/442, A61F5/443 take precedence) - A61F 5/448: Means for attaching bag to seal ring - A61F 13/02: Adhesive bandages or dressings - A61F 2005/4483: {Convex pressure ring} - A61F 2013/00978: {attachments assembly for prosthesis; pouch, e.g. ostomy} - 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 A mounting assembly for an ostomy appliance is disclosed. The mounting assembly comprises a body flange comprising a flexible plastic member comprising a flange ring, a rim, and first and second loops, and an adhesive skin barrier member. The mounting assembly also comprises an ostomy pouch comprising a proximal sheet having an aperture, a distal sheet, and a pouch ring attached to the proximal sheet, surrounding the aperture, the pouch ring comprising an adhesive coating thereon and third and fourth loops extending radially therefrom. The body flange and ostomy pouch are configured for the third and fourth loops to engage within the pocket of the first and second loops, respectively, the pouch ring to fit around the flange ring, and the rim of the flexible plastic member to contact the adhesive coating on the pouch ring. The adhesive skin barrier member has a multi-petaled outer perimeter. ## Claims ### Claim 1 A mounting assembly for an ostomy appliance, comprising: (a) a body flange comprising: (i) a flexible plastic member located on a first side of the body flange, the flexible plastic member comprising a flange ring projecting axially from the body flange, a rim surrounding the flange ring, and first and second loops extending radially from the rim, each of the first and second loops comprising a raised fence around an opening that forms a pocket, and (ii) an adhesive skin barrier member located on an opposite second side of the body flange, and (b) an ostomy pouch comprising: (i) a proximal sheet having an aperture, (ii) a distal sheet sealed to the proximal sheet at their respective peripheries to form the ostomy pouch, and (iii) a pouch ring attached to the proximal sheet, surrounding the aperture of the proximal sheet, the pouch ring comprising an adhesive coating on the pouch ring and third and fourth loops extending radially from the pouch ring, wherein the body flange and ostomy pouch are configured for the third and fourth loops to engage within the pocket of the first and second loops, respectively, the pouch ring to fit around the flange ring, and the rim of the flexible plastic member to contact the adhesive coating on the pouch ring, for assembly of the ostomy appliance; the adhesive skin barrier member has a multi-petaled outer perimeter that has a shape corresponding to 2 to 8 petals extending radially from the adhesive skin barrier member, distributed uniformly around the adhesive skin barrier member, and separated by notches that expand radially from the adhesive skin barrier member; and the 2 to 8 petals each have a width that first increases, then decreases, radially outwardly from the adhesive skin barrier member. ### Claim 2 (depends on 1) The mounting assembly of claim 1, wherein the flexible plastic member further comprises a central dome. ### Claim 3 (depends on 1) The mounting assembly of claim 1, wherein the body flange further comprises: (a) a first double-sided adhesive substrate member adhered to the flexible plastic member opposite the flange ring, and having a size smaller than the multi-petaled outer perimeter of the adhesive skin barrier member, and (b) a second double-sided adhesive substrate member adhered to the first double-sided adhesive substrate member and the adhesive skin barrier member and having a multi-petaled outer perimeter that substantially corresponds in size and shape to the multi-petaled outer perimeter of the adhesive skin barrier member. ### Claim 4 (canceled) ### Claim 5 (depends on 1) The mounting assembly of claim 1, wherein the adhesive skin barrier member has a maximum radius, and at least 50% of the multi-petaled outer perimeter of the adhesive skin barrier member extends to the maximum radius of the adhesive skin barrier member. ### Claim 6 (depends on 1) The mounting assembly of claim 1, wherein the shape of the multi-petaled outer perimeter of the adhesive skin barrier member corresponds to 3 to 6 petals. ### Claim 7 (depends on 1) The mounting assembly of claim 1, wherein the rim of the flexible plastic member is substantially annular. ### Claim 8 (depends on 1) The mounting assembly of claim 1, wherein the first and second loops are diametrically opposed, and the third and fourth loops are diametrically opposed. ### Claim 9 (depends on 1) The mounting assembly of claim 1, wherein the adhesive skin barrier member comprises an elastomer hydrocolloid mixture. ### Claim 10 (depends on 1) The mounting assembly of claim 1, further comprising a first removable protective film covering the adhesive skin barrier member, and a second removable protective film covering the adhesive coating on the pouch ring. ### Claim 11 (depends on 1) The mounting assembly of claim 1, wherein the flexible plastic member and the adhesive skin barrier member each have a stoma inlet portal, centrally positioned and extending therethrough. ### Claim 12 (depends on 1) An ostomy appliance comprising the mounting assembly of claim 1, wherein the body flange and the ostomy pouch are in assembled engagement based on the third and fourth loops engaging within the pocket of the first and second loops, respectively, the pouch ring fitting around the flange ring, and the rim of the flexible plastic member contacting the adhesive coating on the pouch ring. ### Claim 13 (depends on 1) A method of adhering an ostomy appliance to an ostomate at a peristomal skin surface of the ostomate, the ostomy appliance comprising the mounting assembly of claim 1, wherein the flexible plastic member and the adhesive skin barrier member each have a stoma inlet portal, centrally positioned and extending therethrough, the method comprising the steps of: (1) placing the adhesive skin barrier member at the peristomal region of the ostomate, such that the stoma inlet portals of the flexible plastic member and the adhesive skin barrier member are aligned with a stoma of the ostomate, (2) engaging the third loop with the pocket of the first loop, (3) fitting the pouch ring around the flange ring, (4) engaging the fourth loop with the pocket of the second loop, and (5) contacting the rim of the flexible plastic member to the adhesive coating on the pouch ring, thereby adhering the ostomy appliance to the ostomate at the peristomal skin surface of the ostomate. ### Claim 14 (depends on 13) The method of claim 13, wherein the mounting assembly further comprises a first removable protective film covering the adhesive skin barrier member, and a second removable protective film covering the adhesive coating on the pouch ring, the method further comprising: a step of removing the first removable protective film from the adhesive skin barrier member prior to step (1); and a step of removing the second removable protective film from the adhesive coating on the pouch ring prior to steps (2) to (5). ### Claim 15 (depends on 13) The method of claim 13, wherein the ostomy appliance adheres to the ostomate at the peristomal skin surface of the ostomate with a smooth fit. ### Claim 16 (depends on 13) The method of claim 13, wherein the ostomy appliance adheres to the ostomate at the peristomal skin surface of the ostomate without application of adhesive tape to the ostomy appliance or to the ostomate. ### Claim 17 (depends on 1) A method of adhering an ostomy appliance to an ostomate at a peristomal skin surface of the ostomate, the ostomy appliance comprising the mounting assembly of claim 1, the method comprising the steps of: (0) cutting a stoma inlet portal through at least the adhesive skin barrier member, such that the flexible plastic member and the adhesive skin barrier member each have a stoma inlet portal, centrally positioned and extending therethrough, (1) placing the adhesive skin barrier member at the peristomal region of the ostomate, such that the stoma inlet portals of the flexible plastic member and the adhesive skin barrier member are aligned with a stoma of the ostomate, (2) engaging the third loop with the pocket of the first loop, (3) fitting the pouch ring around the flange ring, (4) engaging the fourth loop with the pocket of the second loop, and (5) contacting the rim of the flexible plastic member to the adhesive coating on the pouch ring, thereby adhering the ostomy appliance to the ostomate at the peristomal skin surface of the ostomate. ### Claim 18 (depends on 17) The method of claim 17, wherein the mounting assembly further comprises a first removable protective film covering the adhesive skin barrier member, and a second removable protective film covering the adhesive coating on the pouch ring, the method further comprising: a step of removing the first removable protective film from the adhesive skin barrier member prior to steps (0) and (1); and a step of removing the second removable protective film from the adhesive coating on the pouch ring prior to steps (2) to (5). ### Claim 19 (depends on 17) The method of claim 17, wherein the ostomy appliance adheres to the ostomate at the peristomal skin surface of the ostomate with a smooth fit. ### Claim 20 (depends on 17) The method of claim 17, wherein the ostomy appliance adheres to the ostomate at the peristomal skin surface of the ostomate without application of adhesive tape to the ostomy appliance or to the ostomate. ### Claim 21 (depends on 1) The method of claim 1, wherein the width of each of the 2 to 8 petals is a width measured as an arcuate length with respect to a center of the adhesive skin barrier member.