Ostomy appliance

Patent metadata

Field	Value
Publication number	US-10278857-B2
Application number	US-201414764033-A
Country	US
Kind code	B2
Filing date	Jan 28, 2014
Priority date	Jan 29, 2013
Publication date	May 7, 2019
Grant date	May 7, 2019

Abstract

A one-piece or two-piece ostomy appliance comprising a base plate ( 1 ), the base plate comprising an adhesive wafer ( 11 ) that comprises a top film ( 8 ) and at least one skin-friendly adhesive ( 9 ) on a proximal surface thereof, for attaching the base plate to the skin of a user, and a first through-going-hole ( 5 ). Further, a convex element ( 10 ) is arranged distal to a user-interface of the adhesive wafer and has a second through-going hole ( 15 ) of the same diameter as the first through-going hole and being co-axially arranged therewith. The convex element comprises a material which reacts to moisture.

First claim

The invention claimed is:

1. An ostomy appliance comprising a base plate, the base plate comprising:
an adhesive wafer having a first adhesive on a proximal surface of a backing layer, where a proximal surface of the first adhesive forms a user-interface adapted for attachment of the base plate to skin around a stoma of a user, the adhesive wafer having a first through-going hole with a first diameter; and
a convex element connected to the adhesive wafer, the convex element located distal to the user-interface of the adhesive wafer, the convex element having a second through-going hole that forms an innermost edge of the convex element, with the first through-going hole and the second through-going hole adaptable to be sized to fit around a stoma of the user and the second through-going hole is co-axial with the first through-going;
wherein the convex element has a thickness measured between a proximal side and a distal side of the convex element, and the thickness of the convex element measured from the innermost edge of the convex element to an outermost perimeter of the convex element is substantially uniform;
wherein the convex element comprises a second adhesive provided at least at the innermost edge that reacts to moisture by one of dissolving when exposed to moisture, swelling when exposed to moisture, and forming a gel when exposed to moisture such that the innermost edge of the second through-going hole provides a lubricating surface when exposed to moisture from the stoma;
wherein the convex element has a depth of convexity that is greater than the thickness of the convex element.

2. The ostomy appliance according to claim 1 , wherein the convex element is attached to the backing layer.

3. The ostomy appliance according to claim 1 , wherein the convex element is embedded between the first adhesive layer connected to the backing layer and a third adhesive layer located on a side opposite from the first adhesive layer.

4. The ostomy appliance according to claim 1 , wherein a level of moisture absorption of the convex element is equal to or less than a level of moisture absorption of the first adhesive.

5. The ostomy appliance according to claim 1 , wherein the second adhesive is a thermoplastic hydrocolloid.

6. The ostomy appliance according to claim 1 , wherein the second adhesive of the convex element and the first adhesive are formed from identical polymer materials.

7. The ostomy appliance according to claim 1 , wherein the convex element comprises one or more polyethylene based polymers; one or more ethylene vinyl A acetate-based polymers; one or more hydrocolloid powders; one or more hydrophilic polyurethane-based polymers; one or more filler materials and one or more water swellable/soluble polymers.

8. The ostomy appliance according to claim 1 , wherein a portion of the proximal side of the convex element is formed to be convex and a portion of the distal side of the convex element is formed to be concave.

9. The ostomy appliance according to claim 1 , wherein the convex element is connected to the backing layer, and the convex element is concave on a side of the convex element that is farthest way from the backing layer.

10. The ostomy appliance according to claim 1 , wherein the innermost edge of the second through-going hole of the convex element is adapted to change from a solid state to a semi-liquid state when exposed to the moisture of the stoma.

11. The ostomy appliance according to claim 1 , wherein the second through-going hole is co-axial with the first through-going hole such that, when the base plate is applied to the skin of the user, the convex element is configured to overlay a peristomal skin area around the stoma.

12. The ostomy appliance according to claim 1 , wherein the ostomy appliance is a one-piece appliance with an ostomy bag connected to the base plate.

13. The ostomy appliance according to claim 1 , wherein the convex element provides a convexity to the adhesive wafer and to the base plate, and the convex element is adapted to maintain more than 75% of the convexity of the base plate when the base plate is exposed to an axial load of 2.6 Newtons.

14. The ostomy appliance according to claim 1 , wherein a first portion of the proximal side of the convex element adjacent to the innermost edge of the second through-going hole is formed to be convex and a second portion of the proximal side of the convex element adjacent to the outermost perimeter of the convex element is formed to be concave.

15. An ostomy appliance base plate comprising:
a backing film;
a first adhesive coupled to a proximal side the backing film with the first adhesive configured to secure the ostomy appliance around a stoma of a user;
a convex element connected directly to one of the backing film and the first adhesive; and
a through-going hole formed through the backing film, the first adhesive, and the convex element;
wherein a thickness measured between a proximal side and a distal side of the convex element is approximately uniform, and the convex element is formed to have a depth of convexity that is greater than the thickness of the convex element;
wherein the convex element is moisture reactive such that an innermost edge of the through-going hole of the convex element provides a lubricating surface when exposed to moisture of the stoma.

16. The ostomy appliance base plate of claim 15 , wherein the first adhesive contacts a proximal side of the backing film and the convex element contacts a distal side of the backing film.

17. The ostomy appliance base plate of claim 15 , wherein the convex element is located between the first adhesive and the backing film.

18. The ostomy appliance base plate of claim 15 , wherein the convex element is formed from a second adhesive, and the second adhesive is identical to the first adhesive coupled to the backing film.

19. The ostomy appliance base plate of claim 15 , further comprising an ostomy bag connected to a distal side of the backing film.

20. The ostomy appliance according to claim 15 , wherein a first portion of the proximal side of the convex element adjacent to the through-going hole is formed to be convex and a second portion of the proximal side of the convex element adjacent to an outermost perimeter of the convex element is formed to be concave.

Assignees

• Coloplast As

Inventors

• Hansen Michael
• Stroebech Esben

Classifications

• A61F5/4404 Primary

  Details or parts · CPC title

• A61F5/443 Primary

  having {adhesive seals for securing to the body, e.g. of} hydrocolloid type seals, e.g. gels, starches, karaya gums · CPC title

• A61F5/445 Primary

  Colostomy, {ileostomy or urethrostomy} devices (A61F5/441, A61F5/442, A61F5/443 take precedence) · CPC title

• A61F2005/4483

  Convex pressure ring · CPC title

• A61F5/448

  Means for attaching bag to seal ring · CPC title