ANALYTE SENSOR

• US 20090018424A1
• Filed: 03/25/2008
• Published: 01/15/2009
• Est. Priority Date: 10/04/2006
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Leach, Jacob S., Rong, Daiting, Kamath, Apurv Ullas, Brister, Mark, Simpson, Peter C., Saint, Sean, Li, Ying
• Granted Patent: US 8,364,231 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• 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 5/6848 Needles
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/7235 Details of waveform analysis A61B5/349 takes precedence
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

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 continuous analyte sensor system, comprising:

a continuous analyte sensor configured for exposure to a circulatory system of a host and configured to generate a signal associated with an in vivo analyte concentration when the sensor is implanted in the host, and;

sensor electronics configured to process the signal, wherein the sensor electronics comprise a fail-safe module configured to detect a malfunction of the system.

2. The system of claim 1, wherein the fail-safe module is further configured to detect an electrical malfunction.

3. The system of claim 2, wherein the electrical malfunction comprises a short circuit.

4. The system of claim 2, wherein the electrical malfunction is associated with at least one of start-up and sensor break-in.

5. The system of claim 1, wherein the fail-safe module is further configured to detect a fluidics malfunction.

6. The system of claim 5, further comprising a flow control system in fluid communication with the sensor, wherein the system is configured to contact at least a portion of the sensor with a sample of the circulatory system, wherein the fluidics malfunction comprises a malfunction of the flow control system.

7. The system of claim 6, wherein the malfunction of the flow control system comprises at least one of a washing malfunction, a sample collection malfunction, a constriction of a component of the flow control system, and a blood clotting on a portion of the sensor.

8. The system of claim 6, wherein the flow control system comprises a vascular access device comprising a lumen, and at least a portion of the analyte sensor is further configured to reside within the lumen.

9. The system of claim 6, wherein the flow control system comprises a vascular access device and the analyte sensor is integrally formed with the vascular access device.

10. The system of claim 6, wherein the flow control system is configured to deliver a reference solution into the vascular access device.

11. The system of claim 1, wherein the fail-safe module is further configured to detect a sensor malfunction.

12. The system of claim 11, wherein the sensor malfunction comprises at least one of noise on the signal, drift of a sensitivity, drift of a baseline of the sensor, a broken component of the sensor, blood clotting on a portion of the sensor, and cross-talk.

13. The system of claim 1, wherein the fail-safe module is further configured to perform a waveform analysis of the signal.

14. The system of claim 1, wherein the fail-safe module is further configured to perform a steady state and/or transient state analysis of the signal.

15. The system of claim 1, wherein the fail-safe module is further configured to perform a steady state analysis and a transient analysis of the signal.

16. The system of claim 15, wherein the fail-safe module is further configured to evaluate a relationship between the steady state analysis and the transient analysis.

17. The system of claim 1, wherein the fail-safe module is further configured to provide at least one of an alert, an alarm and an instruction.

18. The system of claim 17, wherein the fail-safe module is further configured to evaluate a detected malfunction against a criterion.

19. The system of claim 1, wherein the analyte is glucose.

20. A method for processing continuous analyte sensor data, the method comprising:

placing a continuous analyte sensor in fluid communication with a circulatory system of a host, wherein a sensor system comprises the sensor and sensor electronics, wherein the sensor is configured to generate a signal associated with an in vivo analyte concentration when the sensor is implanted in the host, and wherein the sensor electronics comprises a fail-safe module configured to detect a system malfunction;

exposing the sensor to a sample from the host'"'"'s circulatory system; and

detecting a malfunction of the system.

21. The method of claim 20, further comprising generating a signal associated with glucose.

22. The method of claim 20, wherein the detecting step further comprises detecting an electrical malfunction.

23. The method of claim 20, wherein the detecting step further comprises detecting a fluidics malfunction.

24. The method of claim 20, wherein the placing step further comprises inserting a vascular access device into the host'"'"'s circulatory system.

25. The method of claim 24, wherein the placing step further comprises fluidly coupling the sensor to the vascular access device.

26. The method of claim 20, wherein the detecting step further comprises detecting a sensor malfunction.

27. The method of claim 20, wherein the detecting step further comprises performing a waveform analysis of the signal.

28. The method of claim 20, wherein the detecting step further comprises performing an equilibrium and/or kinetic analysis of the signal.

29. The method of claim 28, wherein the performing step further comprises evaluating a relationship between the equilibrium analysis and the kinetic analysis.

30. The method of claim 20, further comprises providing at least one of an alert, an alarm, and an instruction.

31. The method of claim 30, further comprising evaluating the detected malfunction against a criterion.

32. The method of claim 20, wherein the detecting step further comprises evaluating steady-state information and/or transient information.

33. The method of claim 32, wherein the evaluating step comprises evaluating at least one of sensitivity information and baseline information.