Patent ID: 8343120

Claim:
A process for manufacturing an ostomy bag assembly comprising outer and inner bags secured to one side of a flange; wherein: the flange comprises a polymeric backing film, a layer of bioadhesive for securing the ostomy bag assembly to the body of a patient, and a removable protective layer covering the layer of bioadhesive; the flange has means defining an orifice to enable bodily waste to be received by the inner bag; the outer bag is detachably bonded to a first attachment zone on the polymeric backing film of the flange; the inner bag is secured to a second attachment zone on the polymeric backing film of the flange by means of a pressure sensitive adhesive; the first attachment zone surrounds the second attachment zone and is non-overlapping therewith; the second attachment zone surrounds the means defining the orifice; the first attachment zone is defined by an annular bonding element which is formed from a multilayer polymeric material comprising first and second ethylene vinyl acetate layers and a polymeric support layer interposed therebetween; the first ethylene vinyl acetate layer has a coating of an ethylene vinyl acetate copolymer adhesive thereon; and wherein the first ethylene vinyl acetate layer is bonded to the polymeric backing film of the flange by means of the coating of ethylene vinyl acetate copolymer adhesive, and the second ethylene vinyl acetate layer is bonded to the outer bag; wherein the process comprises the steps of: (a) forming the flange by punching a datum hole in a wafer comprising the polymeric backing film, layer of bioadhesive, and removable protective layer; (b) die cutting the annular bonding element from a web of the multilayer polymeric material; (c) placing the annular bonding element on to the flange so that the annular bonding element is disposed concentrically with respect to the datum hole; (d) heat sealing the annular bonding element to the flange; (e) bringing into contact with the flange a web of a material from which a panel of the outer bag is to be formed and welding said web of a panel of the outer bag to an inner edge of the annular bonding element; (f) placing the inner bag on the flange and applying pressure thereto to bond the pressure sensitive adhesive to the second attachment zone; (g) bringing into contact with said web a panel of the outer bag, a further web of a material from which another panel of the outer bag is to be formed and outline welding said web of a panel of the outer bag and said further web of another panel of the outer bag together so that they form the outer bag and enclose the inner bag; and thereafter (i) cutting said web of a panel of the outer bag and said further web of another panel of the outer bag to release the ostomy bag assembly.