ANALYTE SENSOR

• US 20090242399A1
• Filed: 03/25/2008
• Published: 10/01/2009
• Est. Priority Date: 03/25/2008
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Kamath, Apurv Ullas, Brister, Mark, Simpson, Peter C., Li, Ying, Shariati, Mohammad Ali
• Application Number:
  US12/055,098
• Publication Number:
  US 20090242399A1
• Time in Patent Office: Days
• US Class Current: 204/403.100
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: C12Q 1/001 Enzyme electrodes

Abstract

Systems and methods of use for continuous analyte measurement of a host'"'"'s vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host'"'"'s circulatory system.

Claims

1. A method for processing sensor data from a dual-electrode continuous analyte sensor configured for exposure to a circulatory system of a host in vivo the method comprising:

applying a dual-electrode continuous analyte sensor to a host, wherein the sensor comprises a first working electrode disposed beneath an enzymatic portion of a membrane system and a second working electrode disposed beneath a non-enzymatic portion of the membrane system, wherein the enzymatic portion comprises an enzyme for detecting an analyte and the non-enzymatic portion comprises no enzyme or an inactive form of the enzyme;

receiving a first signal from the first working electrode associated with the analyte and non-analyte related electroactive compounds, and receiving a second signal from the second working electrode associated with the non-analyte related electroactive compounds, wherein the non-analyte related electroactive compounds have an oxidation potential that substantially overlaps with an oxidation potential of the analyte;

estimating a scaling factor, wherein the scaling factor defines a relationship between the first working electrode and the second working electrode; and

processing the first signal and the second signal to obtain a signal substantially without contribution due to non-analyte related electroactive compounds, wherein the processing comprises using the scaling factor.

2. The method for claim 1, wherein the step of applying the sensor to a host comprises contacting the sensor with a fluid.

3. The method for claim 2, wherein the fluid is a bodily fluid and the step of estimating the scaling factor comprises comparing steady-state information of the first signal and steady-state information of the second signal.

4. The method for claim 2, wherein the fluid is a non-bodily fluid and the step of contacting comprises holding the non-bodily fluid substantially stagnant during a time period.

5. The method for claim 4, wherein the step of estimating the scaling factor comprises comparing a signal increase on each of the first working electrode and the second working electrode during the time period.

6. The method for claim 1, wherein the step of estimating a scaling factor comprises evaluating transient signal information for each of the first working electrode and the second working electrode.

7. The method for claim 1, wherein the step of estimating comprises determining a noise amplitude for each of the first working electrode and the second working electrode.

8. The method for claim 6, wherein the step of determining a noise amplitude comprises determining a signal residual for each of the first working electrode and the second working electrode.

9. The method for claim 7, wherein the step of determining a noise amplitude further comprises averaging a stream of signal residuals for each of the first working electrode and the second working electrode.

10. The method for claim 6, wherein the step of estimating is performed during a transient period of a signal, wherein the transient period of the signal comprises at least one of sensor break-in and signal artifact.

11. A system for measuring an analyte, comprising:

a continuous analyte sensor configured for exposure to a circulatory system of a host in vivo the continuous analyte sensor comprising a first working electrode disposed beneath an enzymatic portion of a membrane system and a second working electrode disposed beneath a non-enzymatic portion of the membrane system, wherein the enzymatic portion comprises an enzyme for detecting the analyte and the non-enzymatic portion comprises no enzyme or an inactive form of the enzyme;

a vascular access device configured for fluid contact with a circulatory system of the host, wherein the sensor is located in or on the vascular access device;

a receiving module configured to receive a first signal from the first working electrode and a second signal from the second working electrode, wherein the first signal is associated with the analyte and non-analyte related electroactive compounds, and the second signal is associated with the non-analyte related electroactive compounds, wherein the non-analyte related electroactive compounds have an oxidation potential that substantially overlaps with an oxidation potential of the analyte; and

a processor module configured to process the first signal and the second signal and to estimate a scaling factor, wherein the scaling factor defines a relationship between the first working electrode and the second working electrode, and wherein the processor module is configured to process the first signal and the second signal using the scaling factor, whereby a signal substantially without contribution due to non-analyte related electroactive compounds is obtained.

12. The system of claim 11, further comprising a flow control device configured to meter a flow of a fluid through the vascular access device.

13. The system of claim 12, wherein the fluid is a bodily fluid and the flow control device is configured to withdraw a sample of bodily fluid from the host, whereby the sensor is contacted with the bodily fluid.

14. The system of claim 12, wherein the fluid is a non-bodily fluid and the flow control device is configured to hold the non-bodily fluid substantially stagnant during a time period.

15. The system of claim 14, wherein the processor module is configured to compare a signal increase on each of the first working electrode and the second working electrode during the time period.

16. The system of claim 11, wherein the processor module is configured to evaluate transient signal information for each of the first working electrode and the second working electrode to estimate the scaling factor.

17. The system of claim 11, wherein the processor module is configured to determine a noise amplitude for each of the first working electrode and the second working electrode to estimate the scaling factor.

18. The system of claim 17, wherein the processor module is configured to determine the noise amplitude by determining a signal residual for each of the first working electrode and the second working electrode.

19. The system of claim 17, wherein the processor module is configured to average a stream of signal residuals to determine the noise amplitude for each of the first working electrode and the second working electrode.

20. The system of claim 17, wherein the processor module is configured to determine the noise amplitude during a transient period of a signal, wherein a transient period of the signal comprises at least one of sensor break-in and signal artifact.

21. A system for measuring an analyte, comprising:

a continuous analyte sensor configured for continuous measurement of an analyte in vivo comprising a first working electrode configured to generate a signal comprising analyte and non-analyte components and a second working electrode configured to generate a second signal comprising a non-analyte related component; and

a processor module configured to process the first signal and the second signal using a scaling factor, whereby a signal substantially without contribution due to the non-analyte component is obtained, wherein the scaling factor defines a relationship between the first working electrode and the second working electrode.

22. The system of claim 21, further comprising a flow control device configured to expose the continuous analyte sensor to at least one fluid.

23. The system of claim 22, wherein the fluid is a sample of bodily fluid and the processor module is configured to process steady state information of the first signal and the second signal to estimate the scaling factor.

24. The system of claim 23, wherein the steady state information of the first signal and the second signal is generated after the analyte present in the sample has been substantially used up.

25. The system of claim 22, wherein the fluid is a non-bodily fluid and the processor module is configured to process the steady state information of the first signal and the second signal to estimate the scaling factor.

26. The system of claim 25, wherein the flow control device is configured to hold the non-bodily fluid substantially stagnant for a period of time, and wherein the processor module is configured to process the first signal and the second signal generated during a period of time to estimate the scaling factor.

27. The system of claim 21, wherein the flow control device is configured to wash the continuous analyte sensor with a non-bodily fluid for at least 50% of a time period during which the continuous analyte sensor is applied to a host.

28. The system of claim 27, wherein the flow control device is configured to wash the continuous analyte sensor with a non-bodily fluid for at least 80% of a time period during which the continuous analyte sensor is applied to a host.

29. The system of claim 21, wherein the scaling factor is determined in vitro.

30. The system of claim 21, wherein the scaling factor is at least one of automatically entered into the system, manually entered into the system, programmed into the system, and coded into the system.