Method for monitoring an analyte, analyte sensor and analyte monitoring apparatus

• US 10,575,767 B2
• Filed: 05/29/2015
• Issued: 03/03/2020
• Est. Priority Date: 05/29/2015
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Patel, Anuj M., Decke, Zachary, Liang, Bradley C.
• Primary Examiner(s): Jang, Christian
• Assistant Examiner(s): Alter, Mitchell E
• Application Number:
  US14/726,224
• Publication Number:
  US 20160345873A1
• Time in Patent Office: 1,740 Days
• Field of Search: 600345
• 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 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps

Abstract

A method for monitoring an analyte within the body of a patient, an analyst sensor, and an analyte monitoring apparatus are presented here. In accordance with certain embodiments, the method for monitoring an analyte within the body of a patient includes implanting an analyte sensor at a sensor placement site in the patient. The analyte sensor includes a reference electrode, a counter electrode, a primary working electrode having a first structure, and an auxiliary working electrode having a second structure different from the first structure. The method includes communicating a primary signal from the primary working electrode and an auxiliary signal from the auxiliary working electrode to a processor. Further, the method includes monitoring the primary signal and the auxiliary signal with the processor to characterize a change in a physiological characteristic at the sensor placement site.

Claims

1. A method for monitoring an analyte within the body of a patient, the method comprising:

implanting an analyte sensor at a sensor placement site in the patient, the analyte sensor comprising;

a reference electrode;

a counter electrode;

at least one primary working electrode having a first electrochemical surface area; and

at least one auxiliary working electrode having a second electrochemical surface area less than the first electrochemical surface area;

communicating a primary constant potential sensor current (primary Isig) from the at least one primary working electrode and an auxiliary constant potential sensor current (auxiliary Isig) from the at least one auxiliary working electrode to a processor, wherein the primary Isig and the auxiliary Isig are analyte dependent;

monitoring a level of the analyte in the body of the patient based on the primary Isig and the auxiliary Isig;

identifying an increase in the primary Isig as a result of a decline in oxygen at the sensor placement site;

simultaneous with the increase in the primary Isig, identifying a decrease in the auxiliary Isig as a result of the decline in oxygen at the sensor placement site;

detecting the onset of the decline in oxygen at the sensor placement site in response to the increase in the primary Isig and the simultaneous decrease in the auxiliary Isig; and

further investigating the primary Isig in response to detecting the onset of the decline in oxygen at the sensor placement site.

2. The method of claim 1 further comprising characterizing an increase in electroactive interferent concentration at the sensor placement site in response to the increase in the primary Isig and the decrease in the auxiliary Isig.

3. The method of claim 1 wherein the at least one primary working electrode is adapted to have a first response to an electroactive interferent, wherein the at least one auxiliary working electrode is adapted to have a second response to the electroactive interferent different from the first response.

4. The method of claim 1 wherein each of the at least one primary working electrode and the at least one auxiliary working electrode includes a deposited metal layer, wherein the deposited metal layer forms an outer surface of the at least one auxiliary working electrode, and wherein the at least one primary working electrode includes a plated metal layer that is plated on the deposited metal layer and that forms an outer surface of the at least one primary working electrode.

5. The method of claim 1 further comprising supplying a same operating voltage to the at least one primary working electrode and the at least one auxiliary working electrode.

6. The method of claim 1 further comprising supplying different operating voltages to the at least one primary working electrode and the at least one auxiliary working electrode.

11. The method of claim 1 further comprising supplying a same operating voltage to the at least one primary working electrode and the at least one auxiliary working electrode.

12. The method of claim 1 further comprising supplying different operating voltages to the at least one primary working electrode and the at least one auxiliary working electrode.

7. A method for monitoring an analyte within the body of a patient, the method comprising:

implanting an analyte sensor at a sensor placement site in the patient, the analyte sensor comprising;

a reference electrode;

a counter electrode;

at least one primary working electrode having a first electrochemical surface area; and

at least one auxiliary working electrode having a second electrochemical surface area different from the first electrochemical surface area;

providing measurements of glucose levels at the sensor placement site in a primary constant potential sensor current (primary Isig) from the at least one primary working electrode;

providing measurements of an electroactive interferent at the sensor placement site in an auxiliary constant potential sensor current (auxiliary Isig) from the at least one auxiliary working electrode;

communicating the primary Isig and the auxiliary Isig to a processor wherein the primary Isig and the auxiliary Isig are analyte dependent;

monitoring the primary Isig to identify changes in glucose levels at the sensor placement site; and

monitoring the auxiliary Isig with the processor and comparing simultaneous measurements of the auxiliary Isig and the primary Isig to identify an increase in the electroactive interferent and to further investigate the primary Isig when the primary Isig increases and the auxiliary Isig decreases as a result of the decline in oxygen at the sensor placement site.

8. The method of claim 7 wherein monitoring the primary Isig and the auxiliary Isig comprises sensing alterations in the primary Isig from the at least one primary working electrode and the auxiliary Isig from the at least one auxiliary working electrode.

9. The method of claim 7 wherein the at least one primary working electrode is adapted to have a first response to the electroactive interferent, wherein the at least one auxiliary working electrode is adapted to have a second response to the electroactive interferent different from the first response.

10. The method of claim 7 wherein each of the at least one primary working electrode and the at least one auxiliary working electrode includes a deposited metal layer, wherein the deposited metal layer forms an outer surface of the at least one auxiliary working electrode, and wherein the at least one primary working electrode includes a plated metal layer that is plated on the deposited metal layer and that forms an outer surface of the at least one primary working electrode.