Search

EP-4734891-A1 - RELEASE LINERS FOR OSTOMY LEAKAGE SENSING ACCESSORY

EP4734891A1EP 4734891 A1EP4734891 A1EP 4734891A1EP-4734891-A1

Abstract

A sensing accessory for an ostomy leakage detection system including a sensing region including a plurality of sensors for detecting a leakage, a skin barrier layer for attachment to a user's peristomal skin arranged on a body-side of the sensing region, and a distal-side of the sensing region opposite the body-side, the distal-side configured to attach to an ostomy barrier appliance. The sensing accessory further includes an inlet opening defined by an inner periphery of the sensing region for receiving a stoma, a body-side release liner covering the skin barrier layer, and a distal-side release liner covering the distal-side of the sensing region. The body-side release liner and the distal-side release liner are configured to facilitate removal of the distal-side release liner before the body-side release liner.

Inventors

  • CARLSSON, Jonas P.
  • LATTANZI, Lauren M.
  • SMITH, Anthony B.

Assignees

  • HOLLISTER INCORPORATED

Dates

Publication Date
20260506
Application Date
20240628

Claims (20)

  1. CLAIMS What is claimed is: 1. A sensing accessory for an ostomy leakage detection system comprising: a sensing region comprising a plurality of sensors for detecting a leakage; a skin barrier layer for attachment to user’s peristomal skin arranged on a body-side of the sensing region; a distal-side of the sensing region opposite the body-side, the distal-side configured to attach to an ostomy barrier appliance; an inlet opening defined by an inner periphery of the sensing region for receiving a stoma; a body-side release liner covering the skin barrier layer; and a distal-side release liner covering the distal-side of the sensing region; wherein the body-side release liner and the distal-side release liner are configured to facilitate removal of the distal-side release liner before the body-side release liner, wherein the sensing accessory is attached to the ostomy barrier appliance after removal of the distal-side release liner while the body-side release liner remains attached to the skin barrier layer.
  2. 2. The sensing accessory of claim 1, wherein the body-side release liner is configured to be removed from the sensing accessory with a greater force than the distal-side release liner.
  3. 3. The sensing accessory of claims 1 or 2, wherein the body-side release liner is adhered to the skin barrier layer and the distal-side release liner is adhered to a portion of the skin barrier layer extending past the sensing region.
  4. 4. The sensing accessory of any one of claims 1-3, wherein a line of contact between the body-side release liner and the skin barrier layer, during peeling of the body-side release liner, is greater than a line of contact between the distal-side release liner and the skin barrier layer, during peeling of the distal-side release liner.
  5. 5. The sensing accessory of any one of claims 1-4, wherein the distal-side release liner is opaque.
  6. 6. The sensing accessory of any one of claims 1-5, wherein the body-side release liner is translucent.
  7. 7. The sensing accessory of any one of claims 1-6, wherein the body-side release liner is more rigid than the distal-side release liner.
  8. 8. The sensing accessory of any one of claims 1-7, wherein the distal-side release liner and the body-side release liner are formed from two different materials.
  9. 9. The sensing accessory of any one of claims 1-8, wherein the body-side release liner is formed from a polymeric film.
  10. 10. The sensing accessory of claim 9, wherein the body-side release liner is formed from a polyester film coated with a silicone release agent on one side.
  11. 11. The sensing accessory of any one of claims 1-10, wherein the distal-side release liner is formed from a paper material.
  12. 12. The sensing accessory of claim 11, wherein the distal-side release liner is formed from a polyethylene-coated white paper including a silicone release agent coated on one side.
  13. 13. The sensing accessory of any one of claims 1-12, wherein the body-side release liner comprises printed graphics configured to illustrate where the skin barrier layer is to be mounted, and wherein the distal-side release liner comprises printed graphics configured to illustrate where the distal-side is to be mounted.
  14. 14. The sensing accessory of any one of claims 1-13, wherein the body-side release liner comprises a body-side pull tab and the distal-side release liner comprises a distal-side pull tab.
  15. 15. The sensing accessory of claim 14, wherein the body-side pull tab is a first color and the distal-side pull tab is a second color different than the first color, and wherein the first color and second color are different than a color of body-side release line and a color of the distal-side release liner.
  16. 16. The sensing accessory of any one of claims 14 or 15, wherein the body-side pull tab defines a cutout, wherein the body-side pull tab and the distal-side pull tab extend past the sensing region at the same location, and wherein the distal-side pull tab extends past the cutout.
  17. 17. The sensing accessory of any one of claims 1-16, wherein the skin barrier layer is formed from a hydrocolloid adhesive.
  18. 18. The sensing accessory of any one of claims 1-17, wherein the body-side release liner extends past at least one edge of the skin barrier layer, and wherein the distal-side release liner extends past the at least one edge of the skin barrier layer.
  19. 19. The sensing accessory of any one of claims 1-18, wherein the body-side release liner includes a first center opening defined by an inner periphery of the body-side release liner and aligned with the inlet opening, and the distal-side release liner includes a second center opening defined by an inner periphery of the distal-side release liner and aligned with the inlet opening, wherein a width of at least one of the first and second center openings is a universal width that is less than a width of the inlet opening, wherein the universal width is configured such that the inner periphery of the corresponding release liner is in contact with a post of a sensing accessory packaging while the inner periphery of the sensing region is arranged at a distance away from the post when the sensing accessory is packaged in the sensing accessory packaging.
  20. 20. The sensing accessory of claim 19, wherein, a width of the first center opening is the universal width, and a width of the second center opening is greater than the width of the universal width.

Description

Attorney Docket No.: 37150-134076WO2 (747.01PCT) ATTORNEY DOCKET NO.37150-134076WO2 (747.01PCT) INTERNATIONAL PATENT APPLICATION TITLE RELEASE LINERS FOR OSTOMY LEAKAGE SENSING ACCESSORY INVENTORS Jonas P. Carlsson Lauren M. Lattanzi Anthony B. Smith RELEASE LINERS FOR OSTOMY LEAKAGE SENSING ACCESSORY CROSS REFERENCE TO RELATED APPLICATIONS [0001] This present application claims the benefit and priority of U.S. Provisional Application No.63/510,669, entitled RELEASE LINER FOR OSTOMY LEAKAGE DETECTION SYSTEM, filed June 28, 2023, the disclosure of which is incorporated by reference herein in its entirety. BACKGROUND [0002] This disclosure is related to an ostomy leakage detection system. More particularly, the present disclosure pertains to a release liner for use with an ostomy sensing accessory of the leakage detection system. [0003] Ostomy leakage detection systems can include sensors for detecting the presence of ostomy effluent (or leakage) around a stoma of a user. Such sensors can be part of an accessory that attaches to a barrier and surrounds a stoma. The sensing accessories may require mounting the sensing accessory in a particular manner for correct use. For example, the sensing accessory may have sensors on a body-side of the accessory and therefore it must attach the body-side of the accessory around the stoma to detect a leak. Some users of ostomy appliances may encounter challenges or frustration with orienting the sensing accessory in the correct position for placement and use. Users can also experience frustration when removing a release liner for exposure of an adhesive layer for securing the accessory to the user and/or an ostomy barrier. Thus, there is a need in the art to address and mitigate such frustrations and provide an improved and easy-to-use sensing accessory. [0004] Sensor accessories can also be difficult to package and/or remove from packaging. For example, different sized sensor accessories can have central openings having differing sizes. Such varying configurations can present challenges in packaging and can require custom packaging designs to accommodate various sizes of the sensor accessories, which can increase costs and production time. In addition, adhesives on the surfaces of the accessory can exude or spread after being applied to the accessory during production. As such, there is a need in the art for a sensing accessory that can be efficiently produced and packaged and to account for potential flow of a hydrocolloid adhesive material after production so as to prevent sensor assemblies from sticking to one another and/or the packaging. BRIEF SUMMARY [0005] A sensing accessory for an ostomy leakage detection system is provided according to example embodiments. [0006] In one aspect, a sensing accessory for an ostomy leakage detection system may include a sensing region including a plurality of sensors for detecting a leakage. The sensing accessory may further include a skin barrier layer for attachment to user’s peristomal skin arranged on a body-side of the sensing region, a distal-side of the sensing region opposite the body-side, the distal-side configured to attach to an ostomy barrier appliance, and an inlet opening defined by an inner periphery of the sensing region for receiving a stoma. The sensing accessory may further include a body-side release liner covering the skin barrier layer, and a distal-side release liner covering the distal-side of the sensing region. The body-side release liner and the distal-side release liner may be configured to facilitate removal of the distal-side release liner before the body-side release liner, wherein the sensing accessory may be attached to the ostomy barrier appliance after removal of the distal-side release liner while the body-side release liner remains attached to the skin barrier layer. [0007] In an embodiment, the body-side release liner may be configured to be removed from the sensing accessory with a greater force than the distal-side release liner. [0008] In an embodiment, the body-side release liner may be adhered to the skin barrier layer and the distal-side release liner may be adhered to a portion of the skin barrier layer extending past the sensing region. [0009] In an embodiment, a line of contact between the body-side release liner and the skin barrier layer, during peeling of the body-side release liner, may be greater than a line of contact between the distal-side release liner and the skin barrier layer, during peeling of the distal-side release liner. [0010] In an embodiment, the distal-side release liner may be opaque. [0011] In an embodiment, the body-side release liner may be translucent. [0012] In an embodiment, the body-side release liner may be more rigid than the distal-side release liner. [0013] In an embodiment, the distal-side release liner and the body-side release liner may be formed from two different materials. [0014] In an embodiment, the body-side release liner may be formed from a