Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
2001-01-11
2004-09-14
Calvert, John J. (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C604S332000
Reexamination Certificate
active
06790200
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a method of assembling an ostomy pouch and, more particularly, to a method of assembling a mounting plate for an ostomy pouch and for attracting the plate to a plastic sheet which forms one side of an ostomy pouch.
Typical one-piece ostomy appliances include a mounting faceplate interposed between a convex disc and an ostomy pouch. The proximal convex face of the disc is covered with a hydrocolloid skin barrier to seal against the periostomal skin surfaces of the ostomate. The distal wall of the faceplate is secured to a proximal wall of the pouch about a stoma opening in the pouch either by an adhesive, ultrasonic sealing, or heat sealing. The proximal wall of the faceplate is adhered to the distal face of the convex disc by an adhesive. The faceplate extends beyond the periphery of the convex disc so that the adhesive coating on the proximal wall of the faceplate is adhered to the ostomate's skin to mount the ostomy appliance.
Even though the mounting adhesive is hypoallergenic, medical grade, pressure-sensitive adhesive that is permeable to gas and water vapor, many ostomates find that the repeated removal of adhesive faceplates is quite painful, and, in some cases, causes skin ulceration. Those ostomates prefer the appliance to be belt-mounted with only the hydrocolloid skin barrier in contact with the periostomal skin areas.
SUMMARY OF THE INVENTION
This invention provides an ostomy appliance which overcomes many of the prior art problems and provides a simplified technique for making the appliance.
A method of assembly includes the steps of providing a flexible plastic disc having a convex central body portion and a surrounding annular rim. A first foam disc is provided. The disc has first and second faces coated with a pressure-sensitive adhesive and an outer diameter substantially corresponding to the outer diameter of the plastic disc. A second foam disc having a pressure-sensitive adhesive coating on one of its faces and having an outer diameter greater than the outer diameter of the plastic disc is provided. The other uncoated face of the second foam disc is adhered to the first foam disc. An adhesive hydrocolloid skin barrier disc having an outer diameter corresponding to that of the second foam disc is adhered to the adhesive face of the second disc. The second face of the first foam disc is adhered to the plastic disc. Heat and pressure are applied to the hydrocolloid disc in an annular zone surrounding the convex body portion of the plastic disc to seal the first and second foam disc assembly to the plastic disc, to mold the hydrocolloid disc to the shape of the convex body portion, and to form a mounting disc.
At least one mounting disc is placed on a plastic sheet which will form the proximal wall of one or more ostomy pouches. The proximal surface of the sheet may be covered with a cloth-like porous material for the comfort of the wearer. The center of each disc is die-cut to provide a stoma-receiving opening. The sheet is provided with apertures having diameters generally coinciding with the inside diameter of the annular rim of the convex disc.
With a mounting disc positioned so that the annular rim of the convex disc contacts an annular zone of the sheet surrounding the aperture, heat is applied to the disc to fuse the sheet thereto. Thereafter, the sheet and its attached mounting discs are placed on another sheet which will form the distal wall of the ostomy pouch or pouches. Each pouch is then die-cut to shape and the pouch perimeter is heat-sealed.
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patent: 4561858 (1985-12-01), Allen, Jr. et al.
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patent: 5004464 (1991-04-01), Leise, Jr.
patent: 5015244 (1991-05-01), Cross
patent: 5330454 (1994-07-01), Klingler et al.
patent: 5429626 (1995-07-01), Fenton
patent: 5618276 (1997-04-01), Leise et al.
United Surgical Corporation Training Manual and Catalog, copyright 1968.
Calvert John J.
Kidwell Michele
Marlen Manufacturing and Development Co., Inc.
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