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US 2011/0253533 A1Published application
Device and method for determining analyte levels
AssigneeDexCom, Inc.
InventorsMark C. Shults, Stuart J. Updike, Rathbun K. Rhodes
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Abstract
Devices and methods for determining analyte levels are described. The devices and methods allow for the implantation of analyte-monitoring devices, such as glucose monitoring devices, that result in the delivery of a dependable flow of blood to deliver sample to the implanted device. The devices comprise a unique microarchitectural arrangement in the sensor region that allows accurate data to be obtained over long periods of time.
Claims26
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, wherein the device is 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 a substantially 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 substantially 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 more reference 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 blood,
- 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.
4 more elements
A device for measuring glucose in a bodily fluid, the device comprising:
- a sensor configured to generate a signal associated with a concentration of glucose in a host, wherein the sensor comprises a working electrode and a reference electrode, and 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, wherein the membrane is configured to control a flux of oxygen and glucose therethrough;
- wherein the device is configured, while implanted in the subcutaneous tissue of the host, to respond substantially linearly to changes in glucose concentration at a glucose level up to 400 mg/dL, wherein at least 95% of glucose concentration values measured by the signal are within 25% of one or more reference values for a useful life of the device of no less than 3 days in the subcutaneous tissue of the host, and wherein the reference values are determined by analysis of blood.
1 more element
Dependencies are inferred from the claim text.