Device and method for determining analyte levels

  • US 8,676,288 B2
  • Filed: 06/22/2011
  • Issued: 03/18/2014
  • Est. Priority Date: 03/04/1997
  • Status: Expired due to Fees
First Claim
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1. A device for measuring glucose in a bodily fluid, the device comprising:

  • a sensor operably connected to an electronic circuit and configured to continuously measure a signal associated with a glucose concentration in a host, the sensor comprising a working electrode and a reference electrode, wherein the working electrode and the reference electrode are configured for implantation in a subcutaneous tissue of the host; and

    a membrane disposed on a portion of the sensor, configured to provide at least two phases of sensor function, wherein the at least two phases of sensor function comprise;

    a first phase that occurs after implantation of the device in the subcutaneous tissue and during which the signal provides an unstable measurement of the glucose concentration in the host; and

    a second phase that occurs after the first phase and during which the signal provides a stable measurement of the glucose concentration in the subcutaneous tissue of the host, wherein at least 95% of glucose concentration values measured by the signal are within 25% of one or reference glucose values over a period of time no less than 3 days in the subcutaneous tissue of the host, and wherein the one or more reference values are determined by analysis of the host'"'"'s blood glucose;

    wherein the device is configured to respond substantially linearly to changes in glucose concentration at a glucose concentration of up to about 400 mg/dL.

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