Analyte monitoring device and methods of use

• US 10,231,654 B2
• Filed: 06/23/2015
• Issued: 03/19/2019
• Est. Priority Date: 11/01/2005
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Peyser, Thomas A., Heller, Adam
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US14/747,583
• Publication Number:
  US 20150289789A1
• Time in Patent Office: 1,365 Days
• Field of Search: 600309, 600345-366
• 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 5/0031 Implanted circuitry
• 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 5/14865 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 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units

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 system, comprising:

an in vivo glucose sensor that continuously monitors glucose concentration and generates signals associated with the glucose concentration;

a biocompatible layer located over the sensor to limit one or more biomolecules having one or more predetermined sizes, the biocompatible layer having a pore size smaller than the one or more predetermined sizes;

a processor that processes the generated signals; and

a user interface that outputs information associated with the continuously monitored glucose concentration;

wherein the signals generated by the in vivo glucose sensor have a level of accuracy that increases over a duration of a sensor wear time period measured after a predetermined sensor stabilization period.

2. The system of claim 1, wherein one or more reference measurements associated with a calculation of a mean absolute relative difference value are determined by analysis of blood.

3. The system of claim 1, wherein the level of accuracy corresponds to a mean absolute relative difference value.

4. The system of claim 3, wherein the mean absolute relative difference value decreases during the sensor wear time period.

5. The system of claim 4, wherein the number of generated signals associated with the glucose concentration increases during the sensor wear time period.

6. The system of claim 1, wherein the generated signals associated with the glucose concentration have a level of accuracy corresponding to a first mean absolute relative difference value during a first time period of the sensor wear time period, and a level of accuracy corresponding to a second mean absolute relative difference value at glucose concentrations during a second time period.

7. The system of claim 6, wherein the first time period precedes the second time period during the sensor wear time period.

8. The system of claim 7, wherein the first mean absolute relative difference value is greater than or equal to the second mean absolute relative difference value.

9. The system of claim 6, wherein one or more reference measurements associated with a calculation of the first mean absolute relative difference value and a calculation of the second mean absolute relative difference value are determined by analysis of blood.

10. The system of claim 1, wherein the biocompatible layer is configured to limit at least one of protein or blood clots from adhering to the glucose sensor.

11. The system of claim 1, wherein the biocompatible layer is configured to remain over the sensor for the duration of the sensor wear time period.

12. The system of claim 1, wherein the biocompatible layer is configured to limit one or more biomolecules from adhering to at least an electrode or a sensing layer of the glucose sensor.

13. A device, comprising:

an in vivo glucose sensor that continuously monitors glucose concentration and generates signals associated with the glucose concentration having a level of accuracy that increases on subsequent days over a duration of a sensor wear time period measured after a predetermined sensor stabilization period; and

a biocompatible layer located over the sensor to limit one or more biomolecules having one or more predetermined sizes, the biocompatible layer having a pore size smaller than the one or more predetermined sizes.

14. The device of claim 13, wherein one or more reference measurements associated with a calculation of a mean absolute relative difference value are determined by analysis of blood.

15. The device of claim 13, wherein the level of accuracy corresponds to a mean absolute relative difference value.

16. The device of claim 15, wherein the mean absolute relative difference value decreases during the sensor wear time period.

17. The device of claim 16, wherein the number of generated signals associated with the glucose concentration increases during the sensor wear time period.

18. The device of claim 13, wherein the generated signals associated with the glucose concentration have a level of accuracy corresponding to a first mean absolute relative difference value during a first time period of the sensor wear time period, and a level of accuracy corresponding to a second mean absolute relative difference value at glucose concentrations during a second time period.

19. The device of claim 18, wherein the first time period precedes the second time period during the sensor wear time period.

20. The device of claim 19, wherein the first mean absolute relative difference value is greater than or equal to the second mean absolute relative difference value.

21. The device of claim 19, wherein one or more reference measurements associated with a calculation of the first mean absolute relative difference value and a calculation of the second mean absolute relative difference value are determined by analysis of blood.

22. The device of claim 13, wherein the biocompatible layer is configured to limit at least one of protein or blood clots from adhering to the glucose sensor.

23. The device of claim 13, wherein the biocompatible layer is configured to remain over the sensor for the duration of the sensor wear time period.

24. The device of claim 13, wherein the biocompatible layer is configured to limit one or more biomolecules from adhering to at least an electrode or a sensing layer of the glucose sensor.

25. A device, comprising:

an in vivo glucose sensor that continuously monitors glucose concentration and generates signals associated with the glucose concentration having a level of accuracy corresponding to a mean absolute relative difference value, wherein the mean absolute relative difference value decreases on subsequent days over a duration of a sensor wear time period after a predetermined sensor stabilization period; and

a biocompatible layer located over the sensor to limit one or more biomolecules having one or more predetermined sizes, the biocompatible layer having a pore size smaller than the one or more predetermined sizes.

26. The device of claim 25, wherein one or more reference measurements associated with a calculation of the mean absolute relative difference value are determined by analysis of blood.

27. The device of claim 25, wherein the mean absolute relative difference value progressively decreases during the sensor wear time period.

28. The device of claim 25, wherein the biocompatible layer is configured to limit at least one of protein or blood clots from adhering to the glucose sensor.

29. The device of claim 25, wherein the biocompatible layer is configured to remain over the sensor for the duration of the sensor wear time period.

30. The device of claim 25, wherein the biocompatible layer is configured to limit one or more biomolecules from adhering to at least an electrode or a sensing layer of the glucose sensor.