Ostomy appliance with flexible membrane connector

• US 4,681,574 A
• Filed: 02/07/1986
• Issued: 07/21/1987
• Est. Priority Date: 09/12/1983
• Status: Expired due to Term

• Current Assignee: Eastman Medical Patent Company
• Original Assignee: Dianne Eastman Revocable Trust
• Inventors: Eastman, Dianne
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): KRUTER, JEROME
• Application Number:
  US06/827,795
• Time in Patent Office: 529 Days
• Field of Search: 604/332-345, 128/132 D
• US Class Current: 604/344
• 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 in which an ostomy bag is supported on the user'"'"'s skin by a membrane adhesively held on the skin where the membrane and adhesive layer are very thin, flexible, elastic and highly permeable to water vapor and oxygen tranmission. A stiffening member is removably provided for mounting the very thin, flexible membrane in a spread out condition while it is being attached to the skin, and the stiffening member is thereafter removed so that the appliance is supported on the skin only by the flexible permeable membrane.

Claims

1. An ostomy appliance comprising:

a bag having an opening for receiving material from a stoma,

a thin, flexible membrane having a bag side and a skin side, the membrane having an inner portion connected to the bag circumscribing the opening and an outer portion which is adapted to be supported on the user'"'"'s skin with the bag side exposed to the air,

adhesive means on the skin side of the membrane for attaching the membrane to the peristomal area of the user, said outer portion of said membrane with said adhesive means thereon adapted to transmit weight from the ostomy appliance to the skin of the user, and

a cover sheet overlying the adhesive means on the skin side of the membrane, the cover sheet being removable to expose the underlying adhesive means for attachment of the membrane and the bag to the peristomal area,

said membrane and adhesive layer having;

a combined thickness of less than about ten thousandths of an inch,

a combined elasticity coefficient of less than about 1.6 pounds per inch at 20% elongation, and

a combined water vapor permeability greater than about 300 grams per square meter per 24 hours at 40°

C. and 80% relative humidity.

2. The ostomy appliance of claim 1 having stiffening means removably attached to the outer portion of the membrane for stiffening membrane as it is adhesively mounted on the skin with the stiffening means removably connected to the membrane so that it can be removed after the membrane is adhesively bonded to the skin.

3. The ostomy appliance of claim 2 in which said stiffening means comprises a sheet of material removably attached to the bag side of the membrane over the outer portion of the membrane.

4. The ostomy appliance of claim 3 having a stiffener flange bonded to the bag surrounding the opening with the membrane fixed to the flange in said inner area with the flange having an extension extending outwardly from the flange and downwardly from the opening and attached to the membrane below the opening to prevent wrinkling of the skin and membrane below the opening.

5. The ostomy appliance of claim 2 in which said stiffening means comprises means for removably attaching the outer portion of the bag side of the membrane to the bag.

6. The ostomy appliance of claim 2 in which said stiffening means comprises a portion of the outer portion of the membrane which is severable from the remainder of the membrane after attachment of the inner portion of the membrane to the skin.

7. The ostomy appliance of claim 1 in which said membrane is a film of polyurethane less than two thousandths of an inch thick.

8. The ostomy appliance of claim 1 in which said membrane and adhesive layer have:

a combined thickness of less than about three thousandths of an inch,

a combined elasticity coefficient less than about 0.6 pounds per inch at 20% elongation, and

10. The ostomy appliance of claim 8 in which said membrane is a film of polyurethane less than two thousandths of an inch thick.

9. a combined water vapor permeability greater than about 500 grams per square meter per 24 hours at 40°

C. and 80% relative humidity.