Implantable biosensor
First Claim
1. A system for monitoring analyte levels in an individual comprisingan implantable biosensor that uses an oxidoreductase enzyme and has multiple electrodes, anda processor that receives signals from the electrodes, excludes outlying signals based on a statistical median analysis, and calculates a mean or median from the remaining signals, wherein the statistical median analysis uses a Z-statistic, Median of Absolute Deviations.
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Abstract
The invention consists of a sensor with multiple indicating (sensing) electrodes covered with a selectively permeable membrane for monitoring fluid concentrations in a biological environment. The indicating electrodes respond to changes in certain analytes, such as glucose, through an enzyme-mediated reaction. The currents generated from the enzyme-mediated reactions are transmitted through radio signals to an external receiver where the information is processed and recorded. Through the use of various biomaterials and biochemicals associated with the sensor, the monitoring accuracy is improved and the overall viability is prolonged. The process of foreign body fibrosis (formation of a scar capsule around the implanted sensor) eventually limits the functional life of the device. We teach methods of delivery of certain biochemicals that can increase the functional life of the sensor by inhibiting the formation of the foreign body capsule or by stimulating the growth of capillaries into the capsule.
191 Citations
12 Claims
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1. A system for monitoring analyte levels in an individual comprising
an implantable biosensor that uses an oxidoreductase enzyme and has multiple electrodes, and a processor that receives signals from the electrodes, excludes outlying signals based on a statistical median analysis, and calculates a mean or median from the remaining signals, wherein the statistical median analysis uses a Z-statistic, Median of Absolute Deviations.
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2. A system for monitoring analyte levels in an individual comprising
an implantable biosensor that uses an oxidoreductase enzyme and has multiple electrodes, and a processor that receives signals from the electrodes, excludes outlying signals based on a statistical median analysis, and calculates a mean or median from the remaining signals, wherein each electrode generates a sensor glucose value (SG), outlier exclusion being determined based on a Z score calculated for each sensor at a given time, the Z score being calculated according to the following formula:
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5. A system for monitoring analyte levels in an individual comprising
an implantable biosensor that uses an oxidoreductase enzyme and has multiple electrodes, and a processor that receives signals from the electrodes, excludes outlying signals based on a statistical median analysis, and calculates a mean or median from the remaining signals, wherein the statistical median analysis uses a Z-score.
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7. A system for monitoring analyte levels in an individual comprising
an array of implantable glucose sensors, each sensor using an electrode pair and glucose oxidase to generate real time glucose sensor values (SG), and a processor programmed to exclude outlying SG values based on the difference between a given SG value and the median SG value of all units, wherein the processor is programmed to exclude outlying SG values based on the difference between a given SG value and the median SG value of all units divided by a scaled SG value of all units.
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9. A system for monitoring analyte levels in an individual comprising
an array of implantable glucose sensors, each sensor using an electrode pair and glucose oxidase to generate real time glucose sensor values (SG), and a processor programmed to exclude outlying SG values based on a Z-score.
Specification