Ostomy appliance with extrudable gasket

• US 5,496,296 A
• Filed: 06/06/1994
• Issued: 03/05/1996
• Est. Priority Date: 06/06/1994
• Status: Expired due to Term

• Current Assignee: Dansac A/S
• Original Assignee: Dansac A/S
• Inventors: Holmberg, Steen
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): CLARKE, ROBERT A
• Application Number:
  US08/254,503
• Time in Patent Office: 638 Days
• Field of Search: 604/332-344
• US Class Current: 604/336
• CPC Class Codes: A61F 5/443 having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums adhesives or sealing pads therefor A61L24/00

Abstract

An ostomy appliance of one-piece or two-piece construction having an adhesive faceplate with a stoma-receiving opening for peristomal adhesive attachment of the appliance to a wearer. The faceplate includes a flexible patch which may be formed of non-woven material and is covered on one side with a first layer of pressure-sensitive adhesive material--particularly a skinfriendly, tacky, hydrocolloid-containing, moisture-absorbing skin barrier material--surrounding the stoma-receiving opening, and a second layer of a soft, easily-deformable, and extrudable fluid-resistant sealant material also surrounding that opening. Inward displacement of the sealant material following adhesive attachment of the faceplate to a patient results in the formation in situ of a fluid-resistant gasket that prevents stomal fluids from contacting the peristomal skin surfaces and the first layer of skinfriendly adhesive and possibly dissolving that layer and/or disrupting its attachment to the skin.

Claims

1. An ostomy appliance comprising a collection pouch and faceplate assembly;

said faceplate assembly including a flexible patch having a stoma-receiving opening, a first layer of skinfriendly hydrocolloid-containing adhesive material along one side of said patch about said opening for securing said faceplate assembly to peristomal skin surfaces, and a second layer of adhesive sealant material immediately surrounding said opening;

said adhesive sealant material of said second layer being softer more easily deformable and extrudable, and more resistant to being dissolved or disintegrated by stomal fluids than the skinfriendly hydrocolloid-containing adhesive material of said first layer and being displacable inwardly and axially into said opening for forming a stoma-engaging annular gasket to prevent stomal fluids from contacting said first adhesive layer.

2. The appliance of claim 1 in which said adhesive material of said second layer includes a continuous phase containing a physically cross-linked or irradition cross-linked polymer and one or more hydrocolloids in particulate form dispersed in said continuous phase.

3. The appliance of claims 1 or 2 in which said flexible patch is formed of microporous sheet material.

4. The appliance of claims 1 or 2 in which said first and second layers are in direct planar contact with each other.

5. The appliance of claim 4 in which said faceplate assembly is contoured and has a relatively thick annular inner portion of adhesive material and a relatively thin annular outer flange portion of adhesive material;

said relatively thick annular inner portion being composed of both said first adhesive layer and said second adhesive layer.

6. The appliance of claim 5 in which said outer annular flange portion of adhesive material is composed substantially entirely of said first adhesive layer.

7. The appliance of claims 1 or 2 in which said appliance is a one-piece appliance with said pouch and faceplate permanently connected together.

8. The appliance of claims 1 or 2 in which said appliance is a two-piece appliance with said pouch and faceplate being detachably connected together.

9. An ostomy appliance comprising a collection pouch and faceplate assembly;

said faceplate assembly including a flexible patch having a stoma-receiving opening, a first layer of skinfriendly hydrocolloid-containing adhesive material along one side of said patch about said opening for securing said faceplate assembly to peristomal skin surfaces, and a second layer of relatively soft, easily-deformable and extrudable, adhesive sealant material of a composition that is resistant to being dissolved or disintegrated by stomal fluids and that immediately surrounds said opening;

said second layer being displacable inwardly and axially into said opening for forming a stoma-engaging annular gasket to prevent stomal fluids from contacting said first adhesive layer;

said first and second layers being in direct planar contact with each other;

said faceplate assembly being contoured and having a relatively thick annular inner portion of adhesive material and a relatively thin annular outer flange portion of adhesive material;

said relatively thick annular inner portion and said annular outer flange portion being composed of both of said first adhesive layer and said second adhesive layer.

10. An ostomy appliance comprising a collection pouch and faceplate assembly;

said faceplate assembly including a flexible patch having a stoma-receiving opening, a first layer of skinfriendly hydrocolloid-containing adhesive material along one side of said patch about said opening for securing said faceplate assembly to peristomal skin surfaces, and a second layer of relatively soft, easily-deformable and extrudable, adhesive sealant material of a composition that is resistant to being dissolved or disintegrated by stomal fluids and that immediately surrounds said opening;

said second layer being displacable inwardly and axially into said opening for forming a stoma-engaging annular gasket to prevent stomal fluids from contacting said first adhesive layer;

said appliance being a two-piece appliance with said pouch and faceplate being detachably connected together;

said second adhesive layer having opposite faces covered by first and second films of thin, flexible material;

said films each having concentric inner and outer portions with said inner portion of one of said films being secured to said patch adjacent said opening;

said one film having its outer portion unsecured to said patch to permit the outer portions of said films to be squeezed together between a user'"'"'s fingers for extruding said sealant material of said second adhesive layer into said stoma opening.

11. The appliance of claim 10 in which a relatively stiff flange ring is secured to said outer portions of said films;

said pouch being provided with an adhesive attachment ring for detachable connection to that part of said faceplate assembly providing said stiff flange ring.