Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...
Reexamination Certificate
1999-11-22
2001-03-06
Yasko, John B. (Department: 3763)
Surgery
Means and methods for collecting body fluids or waste material
Receptacle attached to or inserted within body to receive...
C604S344000
Reexamination Certificate
active
06197010
ABSTRACT:
BACKGROUND AND SUMMARY
In conventional manufacture of the faceplate assemblies for use with two-piece ostomy appliances, it is common practice to produce and store each of the several components and then join them together, often by hand, at the time of final assembly. For example, adhesive wafers are customarily manufactured by extruding skin barrier material onto a receiving web and then die-cutting and storing the wafers for later assembly with other parts or sub-assemblies needed for the final product. While it might be thought that manufacturing efficiencies are enhanced by high-speed production of each of the various components and sub-assemblies, just the opposite is believed to be the case if subsequent assembly steps occur at different locations, or at different times, and require storage, handling, and additional procedures such as inspections or re-inspections, further testing, and the like. Furthermore, high-speed production equipment often has the disadvantage of being difficult and time-consuming to convert to the manufacture of similar components differing in size, shape or composition—compelling reasons for favoring large production runs which in turn increases the problems of handling and storage operations.
Co-owned U.S. Pat. No. 5,716,475 is directed to a method of making wafers of adhesive skin barrier material that does not involve extruding a sheet or web of such material and then die-cutting the sheet to form the individual wafers. Instead, such wafers are formed by an injection and compression molding operation in which discrete mounds of soft, pliant barrier material are deposited one-by-one on an intermittently-advanced web, covered by a second web, and then compressed into the desired shape. Although not as adaptable as extrusion techniques for high-speed production of wafers, the patented method results in products that are considered superior in quality because the molecular orientations of each wafer are more uniform in radial directions in contrast to wafers of extruded barrier material which tend to have molecular orientations predominately in the machine direction and, as a result, have physical properties that can be considerably different depending on the direction of measurement.
One aspect of this invention lies in the discovery that the injection/compression molding method of the aforementioned patent has the further advantage of being particularly amenable to coordination with automated production of other components, with all such operations being carried out simultaneously and continuously in an in-line fashion to yield finished products, thereby eliminating most if not all of the problems and expenses of handling, storage and transfer described above. More specifically, the method is a combination of in-line operations in which the assembling procedures are integrated with the molding, forming, cutting, and other parts-making operations to provide a continuity of automated steps resulting in the production of finished products, thereby greatly reducing the labor content in the manufacturing cost.
A faceplate embodying this invention comprises a coupling ring having a radially outwardly-extending flange portion that is embedded within the faceplate and is therefore not visible or subject to exposure from either side of the faceplate. In addition to appearance advantages, such a construction shields the flange portion of the coupling ring, prevents liquids (and solids) from migrating inwardly between the outer edge of the flange portion and the front (pouchside) surface of the faceplate, and enhances the security of attachment between the coupling ring and the faceplate per se. A protective cover layer is preferably formed of a soft, flexible nonwoven fabric and extends without interruption from the annular connecting portion of the coupling ring to the outermost limits of the faceplate. Unlike many other faceplate constructions that also utilize nonwoven fabric, usually in the form of windowframing strips or rings of microporous adhesive tape, the faceplate of this invention utilizes hydrocolloid-containing skin barrier material as a skinfriendly moisture-absorbing adhesive and as the sole means for securing the entire bodyside surface of the faceplate to the peristomal skin surfaces of a wearer. A liquid-impervious backing film interposed between the layer of skin barrier adhesive and the nonwoven layer, and coextensive in area with the liquid-absorbing adhesive layer, prevents strike-through of effluent into the nonwoven fabric. Thus, the backing film, skin barrier adhesive layer, and nonwoven layer all have coextensive outer peripheral edges.
Other features, advantages, and objects of the invention will become apparent from the specification and drawings.
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Botten Ronald S.
Leise, Jr. Walter F.
McDonald, Jr. John W.
Passalaqua James J.
Rigas Demetrios
Hollister Incorporated
Tilton Fallon Lungmus
Yasko John B.
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