Transcutaneous analyte sensor

• US 8,000,901 B2
• Filed: 08/09/2010
• Issued: 08/16/2011
• Est. Priority Date: 08/01/2003
• Status: Expired due to Term

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brister, Mark C., Kamath, Apurv Ullas, Brauker, James H., Goode, Paul V.
• Primary Examiner(s): Lau; Tung S
• Application Number:
  US12/853,235
• Publication Number:
  US 20100305869A1
• Time in Patent Office: 372 Days
• Field of Search: 702/19
• US Class Current: 702/19
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots

Abstract

The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Claims

1. A device for monitoring a glucose concentration in a host, the device comprising:

a substantially continuous glucose sensor configured to produce sensor data indicative of a glucose concentration in a host; and

an integrated receiver configured to receive the sensor data from the substantially continuous glucose sensor, wherein the integrated receiver comprises;

an in vitro single point glucose monitor configured to receive a biological sample from the host and to measure a glucose concentration in the sample;

a processor module; and

a computer readable memory comprising;

instructions configured to cause the processor module to calibrate the sensor data received from the substantially continuous glucose sensor;

instructions configured to cause the processor module to determine a rate of change of the calibrated sensor data;

instructions configured to cause the processor to determine whether the rate of change is within a range of rates of change delimited by maximum normally sustainable rates of change of glucose in humans; and

instructions configured to allow the processor module to calibrate the sensor data when the rate of change is within the range of rates of change delimited by maximum normally sustainable rates of change of glucose in humans, but not allow the processor module to calibrate the sensor data when the rate of change is outside the range of rates of change delimited by maximum normally sustainable rates of change of glucose in humans.

2. The device of claim 1, wherein the maximum normally sustainable rates of change of glucose in humans is within of a range of about +/−

4 mg/dL/min.

3. The device of claim 1, wherein the instructions configured to allow the processor module to calibrate the sensor data comprise instructions configured to match the sensor data with a substantially time corresponding glucose concentration measurement obtained from the in vitro single point glucose monitor.

4. The device of claim 3, wherein the computer readable memory further comprises instructions configured to cause the processor module to evaluate a sensitivity of the substantially continuous glucose sensor determined from the calibration.

5. The device of claim 1, wherein the computer readable memory further comprises instructions configured to cause the processor module to evaluate a concordance of the sensor data and a substantially time corresponding glucose concentration measurement obtained from the in vitro single point glucose monitor.

6. The device of claim 1, wherein the computer readable memory further comprises instructions configured to cause the processor module to evaluate a clinical acceptability of a deviation of the sensor data from a substantially time corresponding reference glucose measurement obtained from the in vitro single point glucose monitor and a risk of the deviation based on a glucose value indicated by the sensor data and/or the reference glucose measurement.

7. The device of claim 1, wherein the computer readable memory further comprises instructions configured to use in vitro sensitivity information during the calibration.

8. The device of claim 1, wherein the computer readable memory further comprises instructions configured to cause the processor module to evaluate an acceleration of the calibrated sensor data.