Patent ID: 6438414
Filing Date: 2002-08-20
Classification: A61B

Abstract:
A collection assembly, for use in a iontophoretic sampling device useful to monitor glucose present in a biological system, said collection assembly comprisinga) a collection insert layer comprised of first and second hydrogels, each hydrogel comprising, (i) an ionically conductive material, (ii) first and second surfaces, and (iii) glucose oxidase; b) a mask layer comprised of a material that is substantially impermeable to glucose, wherein the mask layer (i) has inner and outer faces and said outer face provides contact with said biological system and the inner face is positioned in facing relation with the first surface of each hydrogel, (ii) defines first and second openings that are aligned, respectively, with the first and second hydrogels of the collection insert layer, (iii) each opening exposes at least a portion of the first surface of the aligned hydrogel, and (iv) has a border which extends beyond the first surface of each hydrogel to provide an overhang; and c) a retaining layer having (i) inner and outer faces wherein the inner face is positioned in facing relation with the second surface of each hydrogel, (ii) defines first and second openings that are aligned, respectively, with the first and second hydrogels of the collection insert layer, (iii) each opening exposes at least a portion of the second surface of the aligned hydrogel, and (iv) has a border which extends beyond the first surface of each hydrogel of the collection insert layer to provide an overhang.