Device and method for determining analyte levels
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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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.
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Citations
26 Claims
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1. A device for measuring glucose in a bodily fluid, the device comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A device for measuring glucose in a bodily fluid, the device comprising:
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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 the membrane provides for at least 95% of glucose concentration values measured by the signal being within 25% of one or more reference glucose 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 the host'"'"'s blood glucose. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26)
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Specification