ANALYTE SENSOR

• US 20080197024A1
• Filed: 03/25/2008
• Published: 08/21/2008
• Est. Priority Date: 12/05/2003
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Kamath, Apurv Ullas, Brister, Mark, Simpson, Peter C., Wightlin, Matthew, Saint, Sean, Pryor, Jack, Nolting, John, Leach, Jacob S., Swanson, Vance, Hanson, Curtis
• Application Number:
  US12/055,078
• Publication Number:
  US 20080197024A1
• Time in Patent Office: Days
• US Class Current: 205/778
• 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 5/14865 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: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• 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 system for continuously detecting an analyte in a host in vivo comprising:

a vascular access device configured for fluid communication with a circulatory system of a host; and

a continuous analyte sensor, the sensor comprising a first working electrode disposed beneath an active enzymatic portion of a sensor membrane and configured to generate a first signal associated with associated with the analyte and non-analyte related electroactive compounds having a first oxidation potential, and a second working electrode disposed beneath an inactive-enzymatic or a non-enzymatic portion of the sensor membrane and configured to generate a second signal associated with noise of the analyte sensor, wherein the noise comprises signal contribution due to non-analyte related electroactive species with an oxidation potential that substantially overlaps with the first oxidation potential.

2. The system of claim 1, wherein the first working electrode comprises a first electroactive surface and the second working electrode comprises a second electroactive surface, and wherein the first working electrode and the second working electrode are configured such that an area of the first electroactive surface exposed to a fluid is substantially equivalent to an area of the second electroactive surface exposed to a fluid.

3. The system of claim 2, wherein a configuration of the first working electrode and the second working electrode is at least one of bundled, twisted, and helical.

4. The system of claim 1, wherein the non-analyte related electroactive species comprise at least one species selected from the group consisting of interfering species, non-reaction-related hydrogen peroxide, and other electroactive species.

5. The system of claim 1, further comprising electronics operably connected to the first working electrode and the second working electrode, and configured to process the first signal and the second signal to generate analyte concentration data substantially without signal contribution due to noise.

6. The system of claim 1, wherein the sensor comprises an electrical insulator located between the first working electrode and the second working electrode, wherein the insulator comprises a physical diffusion barrier configured to structurally block a substantial amount of diffusion of at least one of an analyte and a co-analyte between the first working electrode and the second working electrode by a structure that protrudes from a plane that intersects both the first working electrode and the second working electrode.

7. The system of claim 1, wherein the sensor comprises an insulator located between the first working electrode and the second working electrode, wherein the insulator comprises a diffusion barrier configured to substantially block diffusion of at least one of an analyte and a co-analyte between the first working electrode and the second working electrode wherein the diffusion barrier comprises a temporal diffusion barrier configured to block or avoid a substantial amount of diffusion or reaction of at least one of the analyte and the co-analyte between the first working electrode and the second working electrode.

8. The system of claim 1, wherein the sensor comprises an insulator located between the first working electrode and the second working electrode, wherein the insulator comprises a sensor membrane configured to substantially block diffusion of at least one of an analyte and a co-analyte between the first working electrode and the second working electrode by a discontinuity of the sensor membrane between the first working electrode and the second working electrode.

9. The system of claim 1, wherein the first working electrode and the second working electrode are spaced a distance greater than a diffusion distance of at least one of an analyte and a co-analyte such that cross-talk substantially does not occur.

10. The system of claim 1, wherein the first working electrode and the second working electrode are configured and arranged around a circumference of the sensor.

11. The system of claim 1, wherein the vascular access device comprises a lumen and at least a portion of the sensor is disposed within the lumen.

12. The system of claim 1, wherein the vascular access device comprises a hub and the continuous analyte sensor is disposed substantially within the hub.

13. The system of claim 1, wherein the sensor is configured to reside substantially above a plane defined by the host'"'"'s skin.

14. The system of claim 1, wherein the sensor is disposed on a surface of the vascular access device.

15. The system of claim 1, wherein the vascular access device is configured for insertion into at least one of an artery, a vein, a fistula, and an extracorporeal circulatory device configured to circulate at least a portion of the host'"'"'s blood outside of the host'"'"'s body.

16. The system of claim 1, further comprising a flow control device configured to meter a flow of a fluid through the vascular access device.

17. The system of claim 16, wherein the flow control device is configured to meter a flow of a sufficient flow rate of a non-bodily fluid such that the sensor contacts the non-bodily fluid for a sufficient amount of time, such that biofouling does not occur for at least about 3 days of sensor use.

18. The system of claim 17, wherein the sufficient amount of time comprises at least about 50% of a sensor session.

19. The system of claim 16, wherein the flow control device is configured to control fluid contact with the continuous analyte sensor.

20. The system of claim 16, wherein the flow control device meters the non-bodily fluid through the vascular access device for a sufficient amount of time with a sufficient flow rate such that the vascular access device remains patent during a sensor session.

21. The system of claim 20, wherein the sufficient amount of time comprises at least about 50% of a sensor session.

22. The system of claim 1, further comprising an electronics module configured to determine a scaling factor that defines a relationship between the first working electrode and the second working electrode.

23. The system of claim 1, further comprising a fluid coupler configured and arranged to mate with a vascular access device on a first end, and wherein the sensor is at least one of disposed within at least one of a portion of the fluid coupler and disposed at a surface of the fluid coupler.

24. The system of claim 1, wherein the system is configured to calibrate the continuous analyte sensor using a reference fluid.

25. The system of claim 24, wherein the system is configured to auto calibrate without an external reference value.

26. The system of claim 24, wherein the system is configured to calibrate the sensor without a reference data point provided by an external analyte monitor.

27. The system of claim 1, wherein the system is configured to calibrate the sensor using single-point calibration.

28. The system of claim 1, further comprising a reference sensor configured to generate a reference signal associated with a reference analyte in the sample, wherein the continuous analyte sensor is further configured to generate a third signal associated with the reference analyte, and wherein the system is configured to calibrate the continuous analyte sensor using the reference signal and the third signal.

29. The system of claim 28, wherein the reference sensor comprises an optical sensing apparatus.

30. The system of claim 28, wherein the reference sensor and the continuous analyte sensor are configured for simultaneous exposure to a sample of the circulatory system.

31. The system of claim 1, wherein the continuous analyte sensor is a glucose sensor.

32. The system of claim 1, wherein a substantial portion of the continuous analyte sensor has a diameter of less than about 0.025 inches.

33. The system of claim 1, wherein the continuous analyte sensor further comprises a bioinert material or a bioactive agent incorporated therein or thereon.

34. The system of claim 33, wherein the bioactive agent comprises at least one agent selected from the group consisting of vitamin K antagonists, heparin group anticoagulants, platelet aggregation inhibitors, enzymes, direct thrombin inhibitors, Dabigatran, Defibrotide, Dermatan sulfate, Fondaparinux, and Rivaroxaban.

35. A method for continuously detecting an analyte in the host in vivo comprising:

inserting a vascular access device into a circulatory system of a host;

contacting a continuous analyte sensor with a sample from the circulatory system;

generating a first signal associated with the analyte and non-analyte related electroactive compounds having a first oxidation potential in the sample;

generating a second signal associated with noise of the analyte sensor, wherein the noise comprises signal contribution due to non-analyte related electroactive species with an oxidation potential that substantially overlaps with the first oxidation potential in the sample; and

processing the first signal and the second signal to provide a processed signal substantially without a signal component associated with noise.

36. The method of claim 35, further comprising contacting the continuous analyte sensor with a reference solution, whereby at least one reference data point is provided.

37. The method of claim 36, further comprising auto calibrating the continuous analyte sensor using the reference data point.

38. The method of claim 37, wherein the auto calibrating comprises repeatedly contact the continuous analyte sensor with the reference solution during a sensor session.

39. The method claim 35, wherein the contacting step comprises withdrawing a blood sample.

40. The method claim 35, wherein the processing step further comprises determining a scaling factor that defines a relationship between the first working electrode and the second working electrode.

41. The method claim 40, wherein the processing step further comprises calibrating the continuous analyte sensor using the scaling factor.

42. The method claim 35, further comprising contacting a reference sensor with the sample.

43. The method claim 42, further comprising generating a third signal associated with a reference analyte in the sample.

44. The method claim 42, further comprising optically generating a reference signal associated with the reference sensor.

45. The method claim 44, further comprising calibrating the processed signal using the third signal and the reference signal.

46. The method claim 35, wherein the analyte is glucose.

47. The method claim 35, wherein the processing step comprises evaluating steady-state information and transient information, wherein the first and second signals each comprise steady state and transient information.

48. The method claim 47, wherein the evaluating step comprises evaluating at least one of sensitivity information and baseline information.