Medical Devices and Methods

• US 20160015268A1
• Filed: 08/31/2015
• Published: 01/21/2016
• Est. Priority Date: 08/31/2009
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Bernstein, Daniel Milfred, Fennell, Martin J., Sloan, Mark Kent, Love, Michael, He, Lei, Thomas, Christopher Allen, Hoss, Udo, Feldman, Benjamin Jay, Doniger, Kenneth J., Stafford, Gary Ashley, Hayter, Gary Alan, Yee, Phillip, Kiaie, Namvar, Cole, Jean-Pierre, Dinh, Hung, Taub, Marc Barry, Pace, Louis George, Sicurello, Jeffery Mario
• Application Number:
  US14/841,122
• Publication Number:
  US 20160015268A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0238 Means for recording calibration data
• CPC Class Codes: A61B 5/0017 transmitting optical signals transmission by light H04B10/00
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• 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
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Methods and devices to monitor an analyte in body fluid are provided. Embodiments include continuous or discrete acquisition of analyte related data from a transcutaneously positioned in vivo analyte sensor automatically or upon request from a user.

Claims

1. An apparatus, comprising:

an analyte sensor having a portion configured to be in fluid contact with bodily fluid under a skin surface and configured to generate analyte signals;

a Bluetooth communication module;

a data storage unit that stores calibration information; and

sensor electronics configured to receive the signals generated by the analyte sensor and to process the received signals with the calibration information to generate calibrated analyte sensor data, and to generate one or more data packets that includes the calibrated analyte sensor data so that no user performed calibration is required during the entire period of the analyte sensor usage life;

wherein the communication module is configured to connect with a mobile telephone using Bluetooth, and upon connection with the mobile telephone, the sensor electronics is configured to control the communication module to communicate the generated one or more data packets to the mobile telephone at a programmed communication time interval.

2. The apparatus of claim 1, wherein the sensor electronics includes an application specific integrated circuit (ASIC), and further, wherein the data storage unit stores a unique identification information (ID) number for the ASIC, and the one or more data packets include the unique ID number.

3. The apparatus of claim 1, further including an output unit operatively coupled to the sensor electronics to output one or more output indications based on the generated analyte data.

4. The apparatus of claim 3, wherein the one or more output indications includes a visual indicator.

5. The apparatus of claim 3, wherein the one or more output indications includes an audible indicator.

6. The apparatus of claim 3, wherein the data storage unit is configured to store a predetermined threshold information such that when the sensor electronics determines that the calibrated analyte sensor data deviates from the predetermined threshold information, the output unit is configured to output the one or more output indications.

7. The apparatus of claim 1, wherein the entire period of the analyte sensor usage life starts when the sensor electronics is activated, and ends when the sensor electronics is deactivated.

8. The apparatus of claim 7, wherein the sensor electronics is deactivated when no additional signals from the analyte sensor is processed by the sensor electronics.

9. The apparatus of claim 1, wherein the generated analyte signals correspond to monitored analyte level in dermal fluid.

10. The apparatus of claim 1, wherein the generated analyte signals correspond to monitored analyte level in interstitial fluid.

11. The apparatus of claim 1, wherein the analyte sensor includes 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 13, wherein the mediator is crosslinked with the polymer disposed on the working electrode.

15. The apparatus of claim 1, wherein the analyte sensor includes a plurality of electrodes including a working electrode comprising a mediator bonded to a polymer disposed on the working electrode.