IP Library Granted Patent US 12,642,686
Granted Patent B2
US 12,642,686 · App. 17/823,911 · Granted Jun 2, 2026

Ostomy monitoring system and method

Inventors: Michael Seres (Radlett, GB); Anupriya Jai Tilak Naik (Irvine, CA); David Ramirez-Ayala (Baldwin Park, CA); Yumeng Wu (Tustin, CA); Bryan Went (Camarillo, CA); Erick Went (Camarillo, CA); Sabrina Kaefer (Tustin, CA); Irina Dorofeeva (Riverside, CA); Tianbin Zhao (Irvine, CA)
Assignee: CONVATEC TECHNOLOGIES INC.
A61F5/443A61B5/002A61B5/01A61B5/14539A61B5/445A61B5/4848A61B5/6802A61B5/746A61B7/008A61F5/4404A61F5/441A61F5/445A61F5/448G01F23/261G01K3/10G01K13/02A61B5/4875A61B5/7405A61B5/742A61B5/7455A61B2562/0271A61F13/0213A61F13/0246A61F13/42G01K7/223G01K13/026G01K2213/00
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Quick Facts
Patent No.
US 12,642,686
App. No.
17/823,911
Granted
Jun 2, 2026
Kind
B2
Abstract

An ostomy bag can include one or more sensors for measuring one or more metrics. An ostomy wafer can also include one or more sensors for measuring one or more metrics. The sensors can be temperature sensors and/or capacitive sensors, for example, and the metrics can include bag fill, leakage, skin irritation, and phase of stoma output, among others.

Claims (30)

1 . A method of detecting fill of an ostomy bag, the method comprising:

under control of a hardware processor,

sensing capacitance values of a plurality of capacitive sensors disposed between two layers of one of two walls of an ostomy bag in an array comprising a sensor layer, the sensor layer having an outline shaped and sized like the ostomy bag;

calculating a level of the fill of the bag based at least in part on the capacitance values; and

outputting an indication that a volume of bag fill has increased responsive to detecting change in the capacitance values due to effluent entering the bag.

2 . The method of claim 1 , wherein the calculating is performed by machine learning.

3 . The method of claim 2 , wherein the calculating is performed by a trained neural network model.

4 . The method of claim 1 , further comprising sensing temperature values with a plurality of temperature sensors disposed in the ostomy bag, wherein the calculating is based in part on the temperature values.

5 . The method of claim 1 , further comprising creating a plurality of event flags comprising detection of infusion, detection of drain, and detection of the bag on a user.

6 . The method of claim 5 , wherein the detection of infusion is based on readings from temperature sensors located near an opening of the bag configured to be disposed over a user's stoma.

7 . The method of claim 6 , wherein infusion is detected when the readings from the temperature sensors located near the opening of the bag exceed an infusion criteria.

8 . The method of claim 5 , wherein the calculating is performed upon infusion being detected.

9 . The method of claim 5 , wherein the detection of drain is based on readings from temperature and/or capacitive sensors located near a bottom of the ostomy bag.

10 . The method of claim 9 , wherein drain is detected when the readings from the temperature and/or capacitive located near the bottom of the ostomy bag exceed a drain criteria.

11 . The method of claim 10 , wherein the detection of the bag on the user is based on the temperature sensors located near an opening of the bag configured to be disposed over a user's stoma.

12 . The method of claim 9 , further comprising calibrating the capacitive sensors upon one or more of: detecting the drain, or detecting the bag on the user and first readings from the capacitive sensors have been taken.

13 . The method of claim 1 , further comprising smoothing spikes in raw volume calculations.

14 . The method of claim 1 , further comprising causing to be displayed on a user device in electrical communication with the bag one or more of: a volume of bag fill, a restroom location, or a hydration tracker.

15 . The method of claim 1 , further comprising detecting phasing of effluent in an ostomy bag under control of a hardware processor by:

sensing temperature values of a plurality of temperature sensors disposed in an ostomy bag, the plurality of temperature sensors being in contact with the output; and determining a phase of the effluent based in part on the temperature values.

16 . The method of claim 15 , further comprising subtracting gas volume from the volume of bag fill.

17 . The method of claim 15 , wherein the capacitive sensors are arranged in a pattern of lines at non-90 degree angles with respect to one another in the sensor layer, and wherein the plurality of capacitive sensors are located in different vertical and horizontal positions on the sensor layer.

18 . The method of claim 15 , further comprising an insulation layer disposed between the sensor layer and each one of the two walls of the ostomy bag, wherein the insulation layer comprises a foam or a fibrous material.

19 . The method of claim 15 , further comprising an insulation layer disposed between the sensor layer and each one of the two walls of the ostomy bag, wherein the insulation layer comprises polyester or polyurethane.

20 . The method of claim 15 , wherein the sensor layer is disposed on a side of the ostomy bag facing away from a wafer configured to engage a stoma.

21 . The method of claim 15 , further comprising outputting an alarm indicative of a bag fill level wherein alarms represent different fill levels.

22 . The method of claim 15 , wherein the plurality of capacitive sensors in the array of the sensor layer are connected by curved wires configured to flex under patient movement.

23 . The method of claim 15 , wherein the sensor layer is comprises a plurality of layers comprising the sensor layer comprising the array of capacitive sensors, a thermistor sheet, and a layer free of sensors and wherein stomal output resides between the sensor layer comprising the array of capacitive sensors and the layer free of sensors and wherein the thermistor sheet is closest to a wall of the ostomy bag.

24 . The method of claim 15 , wherein the sensor layer is located a side of the ostomy bag away from a user and wherein the sensors array is printed on an ostomy bag layer.

25 . The method of claim 15 , wherein the sensor layer further comprises a plurality of openings varying in size and location configured to improve flexibility of the sensor layer.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2023
From: CONVATEC INC.
To: CONVATEC TECHNOLOGIES INC.
Reel/Frame 062550/0302 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 20, 2023
From: 11 HEALTH AND TECHNOLOGIES LIMITED
To: CONVATEC, INC.
Reel/Frame 062438/0344 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 17, 2022
From: 11 HEALTH AND TECHNOLOGIES INC.
To: 11 HEALTH AND TECHNOLOGIES LIMITED
Reel/Frame 061815/0888 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 2, 2022
From: SERES, MICHAEL; NAIK, ANUPRIYA JAI TILAK; RAMIREZ-AYALA, DAVID; WU, YUMENG; WENT, BRYAN; WENT, ERICK; KAEFER, SABRINA; DOROFEEVA, IRINA; ZHAO, TIANBIN
To: 11 HEALTH AND TECHNOLOGIES INC.
Reel/Frame 060983/0423 →
Continuity (7)
Continuation 16184828 · Nov 8, 2018
Provisional Application 62675360 · May 23, 2018
Provisional Application 62650511 · Mar 30, 2018
Provisional Application 62637974 · Mar 2, 2018
Provisional Application 62584611 · Nov 10, 2017
Provisional Application 62584018 · Nov 9, 2017
Related Publication 20230240882A1 · Aug 3, 2023
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