Medical devices and methods

• US 10,492,685 B2
• Filed: 08/31/2015
• Issued: 12/03/2019
• Est. Priority Date: 08/31/2009
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• 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, Taub, Marc Barry, Pace, Louis George, Sicurello, Jeffery Mario
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US14/841,224
• Publication Number:
  US 20160015267A1
• Time in Patent Office: 1,555 Days
• Field of Search: 600309, 600345-366
• 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 signals corresponding to monitored analyte level in the bodily fluid;

a power supply;

a data storage unit for storing analyte sensor calibration information, the analyte sensor calibration information including a factory calibration value for calibrating data for the generated signals corresponding to the monitored analyte level in the bodily fluid, wherein the factory calibration value is not modified during the entire period of the analyte sensor usage life; and

sensor electronics operatively coupled to the analyte sensor and the power supply, the sensor electronics including a communication component configured to receive the signals generated by the analyte sensor and one or more other components to generate one or more data packets including the received signals from the analyte sensor;

wherein the sensor electronics is configured to operate in a first mode wherein the communication component is in a low power state while the sensor electronics draw power from the power supply to operate the one or more other components; and

wherein the sensor electronics is configured to switch from operating in the first mode into operating in a second mode for the sensor electronics to draw power from radio frequency (RF) power of a remote device and to operate the communication component only using the power drawn from the RF power of the remote device to transmit the generated one or more data packets to the remote device, while the sensor electronics is simultaneously drawing the power from the power supply to operate the one or more other components.

2. The apparatus of claim 1, wherein the sensor electronics is configured to begin drawing the power from the RF power of the remote device when a predetermined level of RF power is detected.

3. The apparatus of claim 2, wherein the sensor electronics only uses the power drawn from the power supply to generate the one or more data packets.

4. The apparatus of claim 2, further including a switch connecting the power supply to the sensor electronics, wherein the switch is open when the predetermined level of RF power is detected such that the sensor electronics begins drawing the power from the RF power of the remote device.

5. The apparatus of claim 4, wherein the switch is closed when the predetermined level of RF power is no longer detected by the sensor electronics such that the sensor electronics only uses the power drawn from the power supply.

6. The apparatus of claim 1, further including a rechargeable power source operatively coupled to the sensor electronics, wherein when the remote device is positioned within a predetermined distance from the sensor electronics, the RF power from the remote device charges the rechargeable power source.

7. The apparatus of claim 1, wherein the bodily fluid includes one of dermal fluid or interstitial fluid.

8. 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.

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

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

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

12. 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.

13. The apparatus of claim 1, wherein the entire period of the analyte sensor usage life corresponds to a time period of monitoring the analyte level in the bodily fluid, and starts when the sensor electronics is activated, and ends when the sensor electronics is deactivated.

14. The apparatus of claim 13, wherein the sensor electronics is deactivated when no additional signals from the analyte sensor is processed by the sensor electronics.

15. The apparatus of claim 1, wherein the data storage unit is further for storing an identification information.

16. The apparatus of claim 15, wherein the sensor electronics is operatively coupled to the data storage unit, and the generated one or more data packets include the identification information and the analyte sensor calibration information.

17. The apparatus of claim 1, wherein the one or more other components comprise a processing component.

18. The apparatus of claim 1, wherein the sensor electronics draws power from the RF power of the remote device, and the communication component transmits the generated one or more data packets to the remote device, at a range of 5 inches or less.

19. A system, comprising:

a subcutaneous analyte sensor in contact with bodily fluid and configured to generate signals corresponding to monitored analyte level in the bodily fluid;

a display device configured to generate an electromagnetic field for communication; and

sensor electronics communicatively coupled to the analyte sensor to receive the generated signals from the analyte sensor and in response generate one or more data packets including the received signals, the sensor electronics comprising;

a rechargeable power source, a processor and a communication component for communicating with the display device using the electromagnetic field, the sensor electronics further configured to draw power from the power source and the electromagnetic field generated by the display device, wherein the sensor electronics is configured to operate in a first mode wherein the communication component is in a low power state while the sensor electronics draw power from the power source to operate the processor to generate the one or more data packets, and to switch the communication component into an operational mode wherein the communication component is powered only using the power drawn from the electromagnetic field so as to transmit the generated one or more data packets to the display device while the sensor electronics is simultaneously drawing the power from the power source to operate the processor, and wherein the sensor electronics is configured to generate the one or more data packets only using power drawn from the rechargeable power source.

20. The system of claim 19, wherein the power source of the sensor electronics does not have an electrical connection with the communication component of the sensor electronics.