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Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator

  • US 6,461,496 B1
  • Filed: 10/27/1999
  • Issued: 10/08/2002
  • Est. Priority Date: 10/08/1998
  • Status: Expired due to Term
First Claim
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1. An electrochemical sensor strip for determining the concentration of glucose in blood or interstitial fluid, the sensor strip comprising:

  • (a) a first inert, non-conducting polymeric base layer and a second inert, non-conducting polymeric base layer, each layer having a side length and a shorter end length;

    (b) a spacer material positioned between and connecting the first and second base layers, the spacer material shaped to define a channel between the layers, the spacer defining;

    (i) a first opening at a first end of the sensor strip;

    (ii) a second opening at a first side edge of the sensor strip; and

    (iii) a sample chamber adjacent the first opening;

    (c) an electrode pair comprising a first working electrode and a counter electrode, each formed on one of the base layers and exposed to the sample chamber, at least a portion of the first working electrode being within 200 μ

    m of a portion of the counter electrode;

    (d) a measurement zone adjacent the first working electrode and counter electrode within the sample chamber, the measurement zone sized to contain a volume of no more than 1 μ

    L of sample;

    (e) redox mediator disposed in the sample chamber;

    (f) an indicator electrode that is a second working electrode formed on the same base layer as the first working electrode and the counter electrode, the indicator electrode;

    (i) exposed to the sample chamber; and

    (ii) positioned farther along the channel from the first opening than the first working electrode; and

    (g) a conductive trace extending from each of the electrodes along a length of the base layer and extending to a position adjacent a second end length of the sensor strip.

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