IP Library › Granted Patent US 12,376,984
Granted Patent B2
US 12,376,984 · App. 17/424,895 · Granted Aug 5, 2025

Stomal sensor patch

Inventor: Esben Stroebech (Hoersholm, DK)
Assignee: Coloplast A/S
A61F5/443A61B5/6811A61B5/6833A61F5/4404
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Quick Facts
Patent No.
US 12,376,984
App. No.
17/424,895
Granted
Aug 5, 2025
Kind
B2
Abstract

Disclosed is a sensor patch ( 50 ) for attachment to a base plate for an ostomy appliance, and a method for manufacturing such sensor patch. The sensor patch having a proximal side and a distal side. The distal side being adapted for attachment to an adhesive surface of the base plate, wherein the adhesive surface of the base plate is adapted for attachment of the base plate to the skin surface of a user. The sensor patch comprises: a sensor assembly ( 204 ) comprising a plurality of electrodes ( 216 ), and a first adhesive sensor layer ( 52 ) forming the proximal side of the sensor patch and being adapted for attachment of the sensor patch to the skin surface of the user. The first adhesive sensor layer comprises a first centre portion ( 62 ) having a first centre thickness and a first outer rim portion ( 64 ) surrounding the first centre portion. The first outer rim portion has a first outer rim thickness decreasing along a radial direction from adjacent the first centre portion to a first outer periphery of the first adhesive sensor layer.

Claims (33)

1. A sensor patch for attachment to a base plate of an ostomy appliance, the sensor patch comprising:

a sensor assembly layer comprising a plurality of electrodes including a first electrode and a second electrode for forming a first sensor;

a first adhesive sensor layer forming a distal side of the sensor patch and being adapted for attachment of the distal side of the sensor patch to the proximal surface of the base plate, wherein the first adhesive sensor layer comprises a first centre portion having a first centre thickness and a first outer rim portion surrounding the first centre portion, wherein the first outer rim portion has a first outer rim thickness decreasing along a radial direction from adjacent the first centre portion to a first outer periphery of the first adhesive sensor layer, and wherein the first outer rim thickness adjacent the first centre portion is the first centre thickness and the first outer rim thickness at the first outer periphery of the first adhesive sensor layer is a first minimum outer rim thickness, wherein the sensor patch comprises a stomal opening with a centre point, the stomal opening being configured to allow passage of output through the stomal opening and into an ostomy pouch attached to the base plate.

2. The sensor patch according to claim 1 , wherein the first centre thickness is between 0.5 mm and 1.5 mm and the first minimum outer rim thickness is less than 0.5 mm.

3. The sensor patch according to claim 1 , wherein a radial distance from the centre point to the first outer rim portion adjacent the centre portion is between 15-35 mm.

4. The sensor patch according to claim 1 , wherein a radial distance from the first outer rim portion adjacent the centre portion to the first outer periphery of the first adhesive sensor layer is between 0.5-20 mm.

5. The sensor patch according to claim 1 , wherein the first adhesive sensor layer has a first inner rim portion being surrounded by the first centre portion, wherein the first inner rim portion has a first inner rim thickness increasing along a radial direction from a first inner periphery of the first adhesive sensor layer to the first centre portion, and wherein the first inner rim thickness adjacent the first centre portion is the first centre thickness and the first inner rim thickness at the first inner periphery of the first adhesive sensor layer is a first minimum inner rim thickness.

6. The sensor patch according to claim 5 , wherein the first minimum inner rim thickness is less than 0.5 mm.

7. The sensor patch according to claim 1 , wherein a radial distance from the centre point to the first centre portion adjacent the first inner rim portion is between 10-30 mm.

8. The sensor patch according to claim 1 , wherein a radial distance of the first inner rim portion from the first inner periphery of the first adhesive sensor layer to the first centre portion is between 0.5-20 mm.

9. The sensor patch according to claim 1 , wherein the first adhesive sensor layer comprises hydrocolloids.

10. The sensor patch according to claim 9 , wherein the hydrocolloids are arranged such that the hydrocolloids being arranged along the first outer periphery of the first adhesive sensor layer have a first outer rim average grain size, and wherein the hydrocolloids arranged in the first centre portion have a first centre average gran size, and wherein the first outer rim average grain size is less than the first centre average grain size.

11. The sensor patch according to claim 10 , wherein the first outer rim average grain size is less than half of the first centre average grain size.

12. The sensor patch according to claim 9 , wherein the hydrocolloids have an average grain size of less than 0.2 mm.

13. The sensor patch according to claim 1 , comprising a first sensor release liner arranged to protect the first adhesive sensor layer and configured to be peeled off by the user prior to application of the base plate with the attached sensor patch to the skin.

14. The sensor patch according to claim 1 , wherein the first electrode forms a first loop surrounding the centre point, and wherein a radial distance from the centre point to the first loop is less than the radial distance from the centre point to the first outer rim portion.

15. The sensor patch according to claim 14 , wherein the second electrode forms a second loop surrounding the centre point, and wherein a radial distance from the centre point to the second loop is less than the radial distance from the centre point to the first loop.

16. The sensor patch according to claim 1 , wherein the first outer rim thickness is decreasing convexly along the radial direction from adjacent the first centre portion to the first outer periphery of the first adhesive sensor layer.

17. The sensor patch according to claim 1 , wherein the first outer rim thickness is decreasing concavely along the radial direction from adjacent the first centre portion to the first outer periphery of the first adhesive sensor layer.

18. The sensor patch according to claim 1 , wherein the first outer rim thickness is decreasing substantially linearly along the radial direction from adjacent the first centre portion to the first outer periphery of the first adhesive sensor layer.

19. A method for manufacturing a sensor patch, the method comprising:

providing a first adhesive sensor material;

laying out a layer of the first adhesive sensor material for forming a first adhesive sensor layer of the sensor patch, wherein the first adhesive sensor material is laid out to form a first centre portion and a first outer rim portion surrounding the first centre portion, wherein the first centre portion has a first centre thickness and the first outer rim portion has a first outer rim thickness gradually decreasing along a radial direction from adjacent the first centre portion to the first outer periphery of the first adhesive sensor layer, and wherein the first outer rim thickness adjacent the first centre portion is the first centre thickness and the first outer rim thickness at the first outer periphery of the first adhesive sensor layer is a first minimum outer rim thickness;

providing a sensor assembly comprising a plurality of electrodes including a first electrode and a second electrode for forming a first sensor; and

arranging the sensor assembly on a distal side of the first adhesive sensor layer, wherein a proximal side of the first adhesive sensor layer is adapted for attachment of the sensor patch to the skin surface of a user and a distal side of the sensor patch is adapted for attachment to an adhesive surface of a base plate, the adhesive surface of the base plate being adapted for attachment to a skin surface of the user.

20. The method according to claim 19 , comprising providing a first sensor release liner, and wherein laying out the layer of the first adhesive sensor material comprises laying out the layer of the first adhesive sensor material on a distal side of the first sensor release liner.

21. The method according to claim 19 , wherein providing the first adhesive sensor material comprises sorting hydrocolloids of the first adhesive sensor material according to grain size.

22. The method according to claim 21 , wherein laying out the layer of the first adhesive sensor material comprises laying out the layer of the first adhesive sensor material for forming the first centre portion with hydrocolloids having a first centre average grain size, and laying out the layer of the first adhesive sensor material for forming the first outer rim portion with hydrocolloids having a first outer rim average grain size, wherein the first outer rim average grain size is less than the first centre average grain size.

23. The method according to claim 21 , wherein sorting the hydrocolloids comprises sorting the hydrocolloids to achieve an average grain size of the hydrocolloids of less than 0.2 mm.

24. The method according to claim 19 , wherein laying out the layer of the first adhesive sensor material for forming the first adhesive sensor layer comprises extruding the first adhesive sensor layer.

25. The method according to claim 19 , wherein laying out the layer of the first adhesive sensor material for forming the first adhesive sensor layer comprises moulding, such as injection moulding, of the first adhesive sensor layer, wherein the mould has a non-planar surface shaped to provide the first outer rim thickness gradually decreasing along the radial direction from adjacent the first centre portion to the first outer periphery of the first adhesive sensor layer.

26. The method according to claim 19 , wherein laying out the layer of the first adhesive sensor material for forming the first adhesive sensor layer comprises scraping the first adhesive sensor material onto a non-planar surface shaped to provide the first outer rim thickness gradually decreasing along the radial direction from adjacent the first centre portion to the first outer periphery of the first adhesive sensor layer.

27. The sensor patch according to claim 1 , wherein the sensor patch is sized to expose an outer portion of the adhesive surface of the base plate, thereby enabling adhesion by the outer portion of the adhesive surface of the base plate to the skin surface of the user, in addition to adhesion by the first adhesive sensor layer of the sensor patch.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 16, 2021
From: STROEBECH, ESBEN
To: COLOPLAST A/S
Reel/Frame 057496/0401 →
Priority Claims (1)
DK PA 2019 70070 · Jan 31, 2019 · national
Continuity (1)
Related Publication 20220087851A1 · Mar 24, 2022
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