Analyte monitoring device and methods of use

• US 10,478,108 B2
• Filed: 02/05/2016
• Issued: 11/19/2019
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wolpert, Howard, Heller, Adam
• Primary Examiner(s): Messersmith, Eric J
• Application Number:
  US15/017,565
• Publication Number:
  US 20160151004A1
• Time in Patent Office: 1,383 Days
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/1118 Determining activity level
• 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 5/1473 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: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• 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: H01L 23/3107 the device being completely enclosed
• CPC Class Codes: H01L 23/49548 Cross section geometry H01L23/49562 takes precedence
• CPC Class Codes: H01L 2924/00 Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/0002 Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H01L 2924/19041 being a capacitor
• CPC Class Codes: H01L 2924/3011 : Impedance

Abstract

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

Claims

1. A physiological monitoring system, comprising:

an analyte sensor to generate signals corresponding to monitored analyte level in bodily fluid under a skin surface of a user;

a motion detector to monitor an activity level of the user corresponding to a completed exercise activity by the user;

a processor operatively coupled to the analyte sensor and the motion detector to determine a previously monitored variation in the analyte level monitored by the analyte sensor based on the monitored activity level of the user, to receive a user-determined bolus quantity, to enable a therapy device to deliver the user-determined bolus quantity, to determine that the determined previously monitored variation in the analyte level exceeds a predetermined threshold, and in response to the determined previously monitored variation in the analyte level exceeding the predetermined threshold, temporarily disable the therapy device from delivering the user-determined bolus quantity; and

a user interface in signal communication with the processor to output a warning of an impending hypoglycemic condition based on the determined previously monitored variation in the analyte level based on the monitored activity level of the user, the user interface configured to output the warning by at least displaying a therapy information relating to the user-determined bolus quantity and a prompt to receive a user input to confirm that the user-determined bolus quantity should be delivered, the therapy information and the prompt to receive the user input being overlaid on a real-time depiction of the analyte level;

wherein the processor is configured to, in response to the user input, re-enable the therapy device to deliver the user-determined bolus quantity.

2. The system of claim 1, wherein the activity level includes a level of exercise.

3. The system of claim 1, wherein when the processor determines an impending hypoglycemic condition, the processor is further configured to modify one or more medication administration related thresholds.

4. The system of claim 3, wherein the medication is insulin.

5. The system of claim 1, wherein the processor is configured to modify a medication administration related threshold based on a low blood glucose index.

6. The system of claim 1, wherein the processor is configured to determine an impending hypoglycemic condition when medication administration exceeding a predetermined threshold is detected.

7. The system of claim 1, wherein the processor is configured to determine the variation in the analyte level after exercise based on the activity level monitored with the motion detector.

8. The system of claim 1, wherein the analyte sensor comprises a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

9. The system of claim 8, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

10. The system of claim 8, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

11. The system of claim 10, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

12. The system of claim 1, wherein the analyte sensor comprises a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.

22. The system of claim 1, wherein the processor is operatively coupled to the analyte sensor and the motion detector to determine the previously monitored variation in the analyte level monitored by the analyte sensor in at least substantially real time.

13. A method, comprising:

receiving analyte signals corresponding to monitored analyte level in bodily fluid under a skin surface of a user using an analyte sensor;

receiving motion signals corresponding to an activity level of the user from a motion detector, the activity level corresponding to a completed exercise activity by the user;

determining a previously monitored variation in the analyte level monitored by the analyte sensor based on the motion signals;

receiving a user-determined bolus quantity;

enabling a therapy device to deliver the user-determined bolus quantity;

determining that the determined previously monitored variation in the analyte level exceeds a predetermined threshold;

in response to the determined previously monitored variation in the analyte level exceeding the predetermined threshold, temporarily disabling the therapy device from delivering the user-determined bolus quantity;

outputting information associated with an impending hypoglycemic condition based on the determined previously monitored variation in the analyte level, the information including a therapy information relating to the user-determined bolus quantity and a prompt to receive a user input to confirm that the user-determined bolus quantity should be delivered, the therapy information and the prompt to receive the user input being overlaid on a real-time depiction of the analyte level; and

in response to the user input, re-enabling the therapy device to deliver the user-determined bolus quantity.

14. The method of claim 13, wherein the previously monitored variation in the analyte level monitored by the analyte sensor is determined in at least substantially real time.

15. The method of claim 13, further including modifying one or more medication administration related thresholds when an impending hypoglycemic condition is determined.

16. The method of claim 13, further including modifying a medication administration related threshold based on a low blood glucose index.

17. The method of claim 13, further including determining an impending hypoglycemic condition when medication administration exceeding a predetermined threshold is detected.

18. The method of claim 13, wherein the analyte sensor comprises a plurality of electrodes including a working electrode comprising an analyte-responsive enzyme bonded to a polymer disposed on the working electrode.

19. The method of claim 18, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

20. The method of claim 18, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

21. The method of claim 20, wherein the mediator is crosslinked with the polymer disposed on the working electrode.