	US 12,201,547 B2
	Method of providing a signal to alert an ostomate of an imminent leakage of stoma fluids
Kristoffer Hansen, Naerum (DK)
Assigned to Coloplast A/S, Humlebaek (DK)
Filed by Coloplast A/S, Humlebaek (DK)
Filed on Jul. 17, 2023, as Appl. No. 18/222,530.
Application 18/222,530 is a continuation of application No. 16/324,909, granted, now 11,744,725, previously published as PCT/DK2017/050259, filed on Aug. 9, 2017.
Claims priority of application No. PA 2016 70619 (DK), filed on Aug. 12, 2016.
Prior Publication US 2023/0355422 A1, Nov. 9, 2023
Int. Cl. A61F 5/44 (2006.01); A61F 5/443 (2006.01)

CPC A61F 5/4404 (2013.01) [A61F 5/443 (2013.01)]

12 Claims

1. A method of providing a signal to alert an ostomate of an imminent leakage of stoma fluids from an ostomy device worn by the ostomate, the method comprising:

providing an ostomy appliance comprising a carrier sheet having a first adhesive deposited on a proximal side of the carrier sheet and adapted to secure the ostomy appliance to skin of the ostomate, a second material deposited on a distal side of the carrier sheet, a hole formed through the first adhesive and the carrier sheet and the second material with the hole adapted to fit the ostomy appliance around a stoma of the ostomate, a connector coupling disposed on the distal side of the carrier sheet and adapted to secure an ostomy bag around the hole, and a signal generator located on the distal side of the carrier sheet and in contact with the second material;

determining a first dissipation rate of the first adhesive that is indicative of at least one of a reduction in load-carrying of the first adhesive and a reduction in liquid barrier of the first adhesive due to contact of the first adhesive with stomal output;

dimensioning a second dissipation rate of the second material to be higher than the first dissipation rate of the first adhesive;

locating the signal generator between the hole and the connector coupling for exposing the signal generator to an interior of the ostomy bag secured to the ostomy appliance and locating an indicator outside of the ostomy bag by positioning the indicator between connector coupling and an outermost perimeter of the carrier sheet; and

providing a warning to the ostomate with the indicator located outside of the ostomy bag of a potential leakage of the stomal output relative to the first adhesive on the proximal side of the carrier sheet based on a dissipation of the second material due to the stomal output sensed by the signal generator exposed to the interior of the ostomy bag.