Low profile ostomy system with repositionable pouch

• US 5,722,965 A
• Filed: 02/29/1996
• Issued: 03/03/1998
• Est. Priority Date: 02/29/1996
• Status: Expired due to Term

• Current Assignee: Convatec Incorporated (ConvaTec Group Plc)
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Kuczynski, Thomas J.
• Primary Examiner(s): Clarke, Robert A.
• Application Number:
  US08/609,318
• Time in Patent Office: 733 Days
• Field of Search: 604/332, 604/336, 604/338, 604/342, 604/344
• 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
• CPC Class Codes: A61F 5/448 Means for attaching bag to seal ring

Abstract

The low profile ostomy system includes an adhesively securable repositionable pouch that bonds to a body-side mounting wafer. The repositionable pouch is removable from the mounting wafer for repositioning if necessary. In a preferred embodiment of the invention, a resealable tape, which is in the form of a foam tape, is located on a face plate of the pouch and a releasable film, which is backed by a foam tape, is located on a body-side mounting wafer. The face plate of the pouch is formed with an extension tab that is accessible before and after the pouch has been secured to the body-side mounting wafer. The extension tab facilitates peeling of the face plate from the body-side mounting wafer during removal of the pouch from the mounting wafer. The foam tape on the body-side mounting wafer and the face plate inhibit formation of wrinkles or kinks at the engagement surfaces of the face plate and body-side mounting wafer when the pouch is removed from the body-side mounting wafer.

Claims

1. An ostomy system comprising:

a) An ostomy pouch including a pouch envelope formed of flexible plastic material defining a waste collection chamber for body waste that passes through a stoma, a waste inlet opening formed in said envelope for positioning around said stoma to permit passage of waste material from said stoma to said collection chamber, a flexible annular adhesive coupling means for said pouch on said envelope at said waste inlet opening, said pouch coupling means having a resealable coupling adhesive, a manipulation tab extending from a generally circular peripheral portion of said pouch coupling means to manipulate positioning and repositioning of said pouch coupling means around the stoma, and

b) a generally annular body-side mounting wafer having an opening for a stoma, said mounting wafer having a biocompatible adhesive layer on one side for securement to a body surface around the stoma, said biocompatible adhesive layer having a peripheral edge and an opposite side with a release film for engagement with the resealable coupling adhesive of said pouch coupling means, such that said pouch can be secured to said mounting wafer when the resealable coupling adhesive of the pouch coupling means engages the releasable film of the mounting wafer, the adhesion between said releasable film and said resealable coupling adhesive being predetermined to permit repeated removal of said pouch coupling means from said mounting wafer, said tab facilitating manipulation, removal and resecurement of said pouch coupling means relative to said mounting wafer, and wherein said body-side mounting wafer includes support means for said releasable film for avoiding wrinkling of said releasable film when said releasable film is flexed or is separated from a coupling bond with the pouch coupling means and wherein said body-side mounting wafer further includes an annular border tape attached to a peripheral portion of said releasable film to overlap the peripheral edge of said biocompatible adhesive layer to cover said peripheral edge of said biocompatible adhesive layer.

2. The ostomy system as claimed in claim 1, wherein said releasable film has an outer circular periphery and an inner circular periphery with a landing surface defined between the outer and inner periphery for the resealable coupling adhesive of said pouch coupling means, said resealable coupling adhesive being on a substrate having an outer circular periphery and an inner circular periphery sized to fit within the outer and inner circular periphery of the releasable film to permit the resealable coupling adhesive to engage the landing surface of the releasable film.

3. The ostomy system as claimed in claim 1, wherein said releasable film extends beyond the perimeter of said resealable coupling adhesive.

4. The ostomy system as claimed in claim 1, wherein said support means is a layer of polyethylene closed cell foam of predetermined thickness.

5. The ostomy system as claimed in claim 4, wherein said polyethylene foam layer is disposed between said biocompatible adhesive layer and said releasable film of said mounting wafer.

6. The ostomy system as claimed in claim 5, wherein said biocompatible adhesive layer, said releasable film and said polyethylene foam layer are substantially co-extensive.

7. The ostomy system as claimed in claim 1, wherein said pouch coupling means is mounted on an outside surface of said pouch envelope to surround said waste inlet opening.

8. The ostomy system as claimed in claim 1, wherein said annular pouch coupling means includes support means for said resealable coupling adhesive for avoiding wrinkling of said resealable coupling adhesive when said pouch coupling means is flexed or is separated from a coupling bond with the body-side mountin wafer, said support means including a layer of polyethylene closed cell foam.

9. The ostomy system as claimed in claim 8, wherein the layer of polyethylene closed cell foam forms a substrate for said resealable coupling adhesive.

10. The ostomy system as claimed in claim 9, wherein said tab is integrally formed with said layer of polyethylene closed cell foam and said tab is an extension of said layer of polyethylene closed cell foam.

11. The ostomy system as claimed in claim 10, wherein one side of said layer of polyethylene closed cell foam is bonded to an outside surface of said pouch envelope, said tab having a first corresponding surface that corresponds to the one side of said layer of polyethylene closed cell foam, said first corresponding surface of said tab being adhesive-free, such that said tab is movable with respect to the outside surface of said pouch envelope.

12. The ostomy system as claimed in claim 11, wherein an opposite side of said layer of polyethylene closed cell foam is coated with said resealable coupling adhesive, and said tab has a second corresponding surface that corresponds to the opposite side of said layer of polyethylene closed cell foam, said second corresponding surface of said tab being rendered non-adhesive, such that said tab is freely movable and manually accessible when the resealable coupling adhesive of said pouch coupling means is engaged with the releasable film of said mounting wafer.

13. The ostomy system as claimed in claim 12, wherein the second corresponding surface of said tab is covered with a film that has a non-adhesive outside surface facing the body-side mounting wafer when the pouch coupling means is adhesively coupled to the body-side mounting wafer.

14. The ostomy system as claimed in claim 1, wherein said annular border tape has a non-adhesive surface corresponding to the release film and an adhesive surface corresponding to the biocompatible adhesive layer, a removable protective paper being provided on the adhesive surface of said annular border tape, said removable protective paper having at least two score lines that define three sections of said removable protective paper, the score lines permitting removal of each one of the sections of said removable protective paper independently of the other two sections, such that removal of one of said three sections of said removable protective paper from said body-side mounting wafer permits manipulation of said body-side mounting wafer to an attachment position on the body surface by gripping the other two sections of the annular border tape while they are covered with said protective paper.

15. The ostomy system as claimed in claim wherein said other two sections of said removable protective paper are located at opposite side edges of said annular border tape and said one section of said removable protective paper is located intermediate said other two sections to permit removal of said protective paper from said other two sections after the border tape at said one section is secured to said body surface.

16. A method for providing wrinkle-free securement, removal and resecurement of an adhesive coupling member of an ostomy pouch and a body-side mounting wafer, comprising:

a) providing the body-side mounting wafer with a landing surface formed of a releasable film,

b) incorporating within the mounting wafer a first layer of polyethylene closed cell foam to support the releasable film, to avoid wrinkling of the releasable film when the releasable film is flexed or separated from a coupling bond with an ostomy pouch,

c) providing an ostomy pouch with an adhesive coupling having an exposed resealable adhesive for engagement with the releasable film of the body-side mounting wafer,

d) supporting the resealable adhesive with a second layer of polyethylene closed cell foam, to avoid wrinkling of the resealable adhesive when the adhesive coupling of the pouch is flexed or separated from a coupling bond with the body-side mounting wafer,

e) attaching the second layer of polyethylene closed cell foam to an outside surface of the ostomy pouch,

f) engaging the resealable adhesive of the pouch coupling with the releasable film of the mounting wafer, and

g) forming a manipulation tab that extends from the periphery of the pouch coupling integral with the first layer of polyethylene closed cell foam for manual gripping to manipulate attachment, removal and resecurement of the pouch coupling with respect to the mounting wafer, and

h) providing a film layer on the tab to inhibit stretching of said tab during gripping of the tab for manipulation of the pouch coupling.