Design and optimization of a selective subcutaneously implantable glucose electrode based on "wired" glucose oxidase

An implantable 0.29 mm o.d. flexible wire electrode was designed for subcutaneous monitoring of glucose. The electrode was formed by sequentially depositing in a 0.09 mm deep shielded recess at the tip of a polyimide-insulated 0.25 mm gold wire a "wired" glucose oxidase (GOX) sensing layer, a mass transport limiting layer, and a nonfouling biocompatible layer. The glucose sensing layer was formed by cross-linking (poly[(1-vinylimidazolyl)osmium(4,4'-dimethylbipyridine)2Cl] )+/2+(PVI13-dme - Os) and GOX with poly(ethylene glycol) diglycidyl ether (PEG). The glucose mass transport restricting layer consisted of a poly(ester sulfonic acid) film (Eastman AQ 29D) and a copolymer of polyaziridine and poly(vinyl pyridine) partially quaternized with methylene carboxylate. The outer biocompatible layer was formed by photo-cross-linking tetraacrylated poly(ethylene oxide). The three layers contained no leachable components and had a total mass less than 2.2 micrograms (approximately 50 ng of Os). When poised at +200 mV vs SCE and operated at 37 degrees C, the 5 x 10(-4) cm2 electrode had in vitro a sensitivity of 1-2.5 nA mM-1. The current increased with the glucose concentration up to 60 mM, and the 10-90% response time was approximately 1 min when the glucose concentration was abruptly raised from 5 to 10 mM. The sensitivity decreased by less than 4% over a test period of 1 week, during which the electrode was operated continuously in a 10 mM glucose physiological buffer solution at 37 degrees C.(ABSTRACT TRUNCATED AT 250 WORDS)