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 Electrochemical sensor

Details
Inventors: Diebold, Eric R.; Kordal, Richard J.; Surridge, Nigel A.; Wilsey, Christopher D.;
Assignee: Boehringer Mannheim Corporation (Indianapolis, IN)
Primary Examiner: Beisner; William H.
Assistant Examiner:
Attorney, Agent or Firm: Young; D. Michael, Kenemore; Max J., Amick; Marilyn L.

A method for fabricating high-resolution, biocompatible electrodes is disclosed, allowing production of an electrochemical sensor which is capable of precise analyte concentration determination on a very small sample size. Electrically conducting material is affixed to a first insulating substrate. A second insulating substrate is then affixed to the electrically conducting material and patterned using photolithography to define an electrode area. Alternatively, the electrically conducting material may be screen printed directly onto a standard printed circuit board substrate in the case of a counter or reference electrode. In either case, the substrate may be rigid or flexible. When the electrodes produced in accordance with the present invention are then used in an electrochemical sensor which includes a reagent, the small and highly-defined electrode areas permit highly-accurate electrochemical analyte measurements to be performed on very small sample sizes.

DETAILED DESCRIPTION This invention is based on the novel adaptation of some techniques common to the PCB industry to produce high-resolution electrodes for use in an electrochemical sensor.
The electrodes produced in accordance with the present invention have highly defined and reproducible size and shape, and importantly have a precisely-defined working electrode area.
When the electrodes are then used in an electrochemical sensor, highly-accurate electrochemical measurements may be performed on very small sample sizes.
A significant advantage to the present invention (when the sensor is used to detect or measure an analyte in a blood sample) is the low blood sample volume required for the electrochemical measurement, thus allowing for a very low pain lancet device which produces low sample volumes.
Since in one embodiment the electrodes are manufactured on separate pieces of substrate material, another advantage of the present invention is the separation of the fabrication processes of the two electrodes, which allows separation of the chemistries associated with the working and the counter electrodes.
Fabricating an electrode in accordance with the present invention involves first attaching a high quality thin metal film (rather than copper foil laminates) to a bare rigid or flexible substrate.
A layer of photoresist is then applied to the thin metal layer and patterned using photolithography to precisely define an electrode area and a contact pad.
Importantly, the photoresist layer is not removed after patterning and acts as an insulator in the finished electrochemical sensor.
Alternatively, a dielectric material may be screen printed directly to the metal layer in a pattern which defines the electrode area and contact pad.
In the case of a reference or counter electrode, the metal may be applied directly to a standard PCB substrate.
The electrodes described above may then be used to fabricate a novel electrochemical sensor in which the electrodes are arranged either in opposing or adjacent form



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