Method and apparatus for providing analyte sensor insertion

• US 9,795,331 B2
• Filed: 04/28/2016
• Issued: 10/24/2017
• Est. Priority Date: 12/28/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Stafford, Gary Ashley
• Primary Examiner(s): JANG, CHRISTIAN YONGKYUN
• Application Number:
  US15/141,819
• Publication Number:
  US 20160242684A1
• Time in Patent Office: 544 Days
• 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 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• 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 5/14546 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

Abstract

Devices and methods for positioning a portion of a sensor at a first predetermined location, displacing the portion of the sensor from the first predetermined location to a second predetermined location, and detecting one or signals associated with an analyte level of a patient at the second predetermined location are disclosed. Also provided are systems and kits for use in analyte monitoring.

Claims

1. A method, comprising:

positioning a portion of an analyte sensor at a first predetermined location at a first predetermined speed, the analyte sensor positioned in fluid contact with a bodily fluid under a skin surface;

displacing the analyte sensor at a second predetermined speed slower than the first predetermined speed from the first predetermined location to a second predetermined location;

retrieving, using one or more processors, a factory determined calibration value stored in a memory storage component, the factory determined calibration value being not modified during a lifetime of the analyte sensor;

detecting one or more signals associated with an analyte level in the bodily fluid under the skin surface; and

generating, using the one or more processors, clinically accurate calibrated analyte sensor data by processing the detected one or more signals with the factory determined calibration value, wherein the detected one or more signals are processed substantially immediately after the positioning the analyte sensor in fluid contact with the bodily fluid, and further, wherein the clinically accurate calibrated analyte sensor data correlates to the analyte level in blood.

2. The method 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.

3. The method of claim 2, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

4. The method of claim 2, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

5. The method of claim 1, wherein the detected one or more signals correspond to monitored analyte levels in at least one of (i) dermal fluid or (ii) interstitial fluid.

6. The method of claim 1, wherein the clinically accurate calibrated analyte sensor data is generated by processing the detected one or more signals only with the factory determined calibration value during an entire lifetime of the analyte sensor spanning from positioning the analyte sensor in contact with the bodily fluid to removal of the analyte sensor from contact with the bodily fluid.

7. The method of claim 1, wherein the memory storage component is operatively coupled to the one or more processors, and wherein the one or more processors are processors of sensor electronics physically coupled to the analyte sensor.

8. The method of claim 1, further including wirelessly communicating the generated clinically accurate calibrated analyte sensor data to a remote location for display.

9. The method of claim 1, wherein the detected one or more signals are processed within 1 to 3 hours after positioning the analyte sensor in fluid contact with the bodily fluid.

10. An apparatus, comprising:

an analyte sensor having a portion for positioning at a first predetermined location at a first predetermined speed and in fluid contact with bodily fluid under a skin surface, the analyte sensor configured to generate one or more signals corresponding to a monitored analyte level, the analyte sensor further configured to have a portion displaced from the first predetermined position to a second predetermined position at a second predetermined speed slower than the first predetermined speed; and

sensor electronics physically coupled to the analyte sensor to receive the generated one or more signals from the analyte sensor, the sensor electronics including a memory storage component and one or more processors operatively coupled to the memory storage component, the one or more processors of the sensor electronics configured to retrieve a factory determined calibration value stored in the memory storage component, to generate clinically accurate calibrated analyte sensor data by processing the generated one or more signals with the factory determined calibration value, wherein the generated one or more signals are processed substantially immediately after the positioning the analyte sensor in fluid contact with the bodily fluid, and further, wherein the clinically accurate calibrated analyte sensor data correlates to the analyte level in blood.

11. The apparatus of claim 10, 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.

12. The apparatus of claim 11, wherein the analyte-responsive enzyme is chemically bonded to the polymer disposed on the working electrode.

13. The apparatus of claim 11, wherein the working electrode comprises a mediator bonded to the polymer disposed on the working electrode.

14. The apparatus of claim 10, wherein the generated one or more signals correspond to monitored analyte levels in at least one of (i) dermal fluid or (ii) interstitial fluid.

15. The apparatus of claim 10, wherein the one or more processors of the sensor electronics is configured to process the generated one or more signals to generate the clinically accurate calibrated analyte sensor data only with the factory determined calibration value during an entire lifetime of the analyte sensor spanning from positioning the analyte sensor in contact with the bodily fluid to removal of the analyte sensor from contact with the bodily fluid.

16. The apparatus of claim 10, wherein the sensor electronics further includes a communication component operatively coupled to the one or more processors, the communication component configured to wirelessly communicate the generated clinically accurate calibrated analyte sensor data to a remote location.

17. The apparatus of claim 10, wherein the one or more processors of the sensor electronics is configured to process the generated one or more signals within 1 to 3 hours after positioning the analyte sensor in fluid contact with the bodily fluid.