Ostomy pouch and method of assembly

An ostomy appliance and a mounting disc include an ostomy pouch having a stoma receiving portal. The mounting disc is sealed about the portal and includes a flexible plastic disc having a convex central body portion and a surrounding annular rim. A first foam disc having an outer diameter corresponding to the outer diameter of the rim is adhesively adhered to the plastic disc. A second foam disc is adhered to an adhesive face of the first foam disc and has an outer diameter greater than the plastic disc. A hydrocolloid skin shield disc having an outer diameter corresponding to the outer diameter of the second foam disc is adhesively adhered to an adhesive face of the second disc.

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.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings, and particularly toFIGS. 1-3, there is illustrated an ostomy appliance assembly10according to this invention. The assembly10includes a mounting disc12, adapted to be attached to a fastening belt (not shown) of an ostomate, and an ostomy pouch14.

The mounting disc12includes a flexible plastic disc16having a convex central body portion18and a surrounding annular rim20. The disc may be molded from a copolymer of ethylene and vinyl acetate (EVA). The EVA copolymer may be “ELVAX”® 450, produced by E.I. DuPont de Nemours, Inc., Wilmington, Del. The disc16is provided with diametrically opposed and radially extending belt mounting loops22at its periphery.

A first soft resilient thermoplastic foam disc24covers the flexible plastic disc16. The foam disc24has pressure-sensitive adhesive layers26and28on each of its faces and one face is attached to the plastic disc16. The foam disc24, when applied to the disc16, has an outer diameter substantially corresponding to the outer diameter of the disc16.

A second soft, resilient thermoplastic foam disc30covers the first foam disc24. The foam disc30has a pressure-sensitive adhesive layer32on one face, and the other face of the disc24is adhesively attached to the adhesive layer28of the first foam disc24so that the pressure-sensitive layer is exposed. The foam disc30has an outer diameter greater than the outer diameters of the first foam disc24and the disc16. The belt mounting loops22do not extend beyond the diameter of the second foam disc30so that the skin of the ostomate is protected from belt hooks passing through the belt mounting loops22.

An adhesive hydrocolloid skin barrier disc34having an outer diameter corresponding to that of the second foam disc30is placed on the adhesive layer32of the second foam disc30. Preferably the exposed surface of the disc34is covered by a thin release film36which is removed just prior to use. Heat and pressure are applied to an annular zone z (FIG. 2) to seal the discs and to smooth the foam and hydrocolloid discs over the convex central body portion18of the plastic disc16.

The adhesive skin barrier disc34is pliable and has both dry and wet tack. Suitable materials are Karaya-glycerine formulations or mixtures of polyacrylamide resins and other polyols and mixtures of elastomers and hydrocolloids. A stoma inlet portal38is provided at the center of the assembly, as illustrated in FIG.2.

The first and second foam discs24and30, the hydrocolloid skin barrier disc34, and the plastic disc16are assembled in the following manner. For ease of handling during the assembly operation, the pressure-sensitive adhesive layers26and28of the first foam disc24are respectively covered by protective liners40and42, and the adhesive layer32of the foam disc30is covered by a protective liner44. The release liner42is stripped from the adhesive layer28and the disc24is adhered concentrically to the foam disc30. To aid in this operation, pilot apertures46and48are respectively provided at the centers of the discs24and30.

After the discs24and30are assembled, the liner44is stripped from the adhesive layer32of the disc30and the adhesive layer32of the disc30is applied concentrically to one face50of the adhesive hydrocolloid skin barrier disc34. To aid in this operation, a pilot aperture52is provide at the center of the adhesive hydrocolloid skin barrier disc34.

After the discs24,30and34are assembled, the liner40is stripped from the adhesive layer26of the disc24and the adhesive layer of the disc24is applied concentrically to the convex face of the plastic disc16. To aid in this operation, a pilot aperture60is provided at the center of the disc16.

After heat and pressure is applied at the zone z, as was previously described, at least one mounting disc12is placed on a plastic sheet54(FIG. 4) which will form the proximal wall56of one or more ostomy pouches14. Each disc12is placed over an opening62(FIG. 2) in the sheet54. The proximal surface of the sheet54may be covered with a cloth-like porous material58for the comfort of the wearer. The pilot openings52,48,46, and60may be die-cut to form the properly sized stoma inlet portal38. Heat and pressure are again applied at the zone z to seal the annular rim20to the sheet54. After the sealing operation, the sheet54is backed by another sheet64which will form a distal wall66of one or more ostomy pouches14. The pouches14are then formed by die-cutting along a line68and heat sealing along a peripheral band70(FIG.1).

While the invention has been shown and described with respect to particular embodiments thereof, those embodiments are for the purpose of illustration rather than limitation, and other variations and modifications of the specific embodiments herein described will be apparent to those skilled in the art, all within the intended spirit and scope of the invention. Accordingly, the invention is not to be limited in scope and effect to the specific embodiments herein described, nor in any other way that is inconsistent with the extent to which the progress in the art has been advanced by the invention.