ANALYTE MONITORING SYSTEM AND METHOD

• US 20150374271A1
• Filed: 09/04/2015
• Published: 12/31/2015
• Est. Priority Date: 06/07/2006
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: McGarraugh, Geoffrey V., Feldman, Benjamin J., Peyser, Thomas A., Goodnow, Timothy T., Rebrin, Kerstin, Mazza, John C.
• Application Number:
  US14/846,607
• Publication Number:
  US 20150374271A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• 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 5/1486 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 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• 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 1/006 for glucose
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C

Abstract

Devices and methods for monitoring an analyte are provided. Embodiments include continuous analyte sensors having a high degree of accuracy.

Claims

1. An in vivo analyte monitoring method, comprising:

positioning an electrochemical analyte sensor under a skin surface of a human and in fluid contact with a bodily fluid for a duration of sensor life ranging from 1 day to 30 days, wherein the electrochemical analyte sensor is adapted to sample an analyte level in the bodily fluid;

wirelessly transmitting a data signal from a transmitter coupled with the electrochemical analyte sensor to a receiver device, the data signal corresponding to an analyte level sampled by the electrochemical analyte sensor;

determining, at the receiver device, the analyte level using the data signal received from the electrochemical analyte sensor; and

displaying, on a display of the receiver device, the analyte level, wherein the analyte level is changing at a rate between −

2 mg/dl/min to 2 mg/dl/min and wherein the analyte level is displayed without confirming the accuracy level of the received data signal using an adjunctive measurement.

2. The method of claim 1, wherein the electrochemical analyte sensor is calibrated with factory-only calibration.

3. The method of claim 1, wherein the adjunctive measurement includes a blood glucose measurement.

4. The method of claim 1, further comprising generating an alarm or an alert, at the receiver device, when the analyte level is at or near a threshold level.

5. The method of claim 4, wherein the threshold level is indicative of hypoglycemia.

6. The method of claim 4, wherein the threshold level is indicative of hyperglycemia.

7. The method of claim 1, further comprising:

receiving, by an insulin infusion device, the determined analyte level from the receiver device; and

automatically administering insulin to the human with the insulin infusion device based on the analyte level received from the receiver device.

8. The method of claim 1, wherein an insulin infusion device is integrated with the receiver device, the method comprising automatically administering insulin to the human with the insulin infusion device based on the analyte level determined by the receiver device.

9. The method of claim 1, wherein the electrochemical analyte sensor comprises a working electrode that comprises an analyte-responsive enzyme and a mediator.

10. The method of claim 9, wherein a polymer is chemically bonded to a functional group on a surface of the working electrode.

11. An in vivo analyte monitoring system, comprising:

an electrochemical analyte sensor adapted to be positioned under a skin surface of a human and in fluid contact with a bodily fluid for a duration of sensor life ranging from 1 day to 30 days, wherein the electrochemical analyte sensor is adapted to sample an analyte level in the bodily fluid;

a wireless transmitter coupled with the electrochemical analyte sensor and adapted to transmit a data signal corresponding to an analyte level sampled by the electrochemical analyte sensor;

a receiver device comprising a display, wherein the receiver device is adapted to determine the analyte level using the data signal received from the electrochemical analyte sensor and display the analyte level when changing at a rate between −

2 mg/dl/min to 2 mg/dl/min without confirmation of the accuracy level of the received data signal with an adjunctive measurement.

12. The system of claim 11, wherein the receiver device is operable with the electrochemical analyte sensor calibrated with factory-only calibration.

13. The system of claim 11, wherein the adjunctive measurement includes a blood glucose measurement.

14. The system of claim 11, wherein the receiver device generates an alarm or an alert when the analyte level is at or near a threshold level.

15. The system of claim 14, wherein the threshold level is indicative of hypoglycemia.

16. The system of claim 14, wherein the threshold level is indicative of hyperglycemia.

17. The system of claim 11, further comprising an insulin infusion device adapted to receive the determined analyte level from the receiver device and automatically administer insulin to the human based on the analyte level received from the receiver device.

18. The system of claim 11, further comprising an insulin infusion device integrated with the receiver device, the insulin infusion device adapted to automatically administer insulin to the human based on the analyte level determined by the receiver device.

19. The system of claim 11, wherein the electrochemical analyte sensor comprises a working electrode that comprises an analyte-responsive enzyme and a mediator.

20. The system of claim 19, wherein a polymer is chemically bonded to a functional group on a surface of the working electrode.