Analyte monitoring device and methods of use

• US 8,652,043 B2
• Filed: 07/20/2012
• Issued: 02/18/2014
• Est. Priority Date: 01/02/2001
• Status: Expired due to Term

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Drucker, Steven H., Jin, Robert Y., Funderburk, Jeffery V.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US13/555,057
• Publication Number:
  US 20120316412A1
• Time in Patent Office: 578 Days
• Field of Search: 600/309, 600345-366
• US Class Current: 600/365
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• 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 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• 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 5/14532 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 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6849 in combination with a needle set
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/743 : Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7445 : Display arrangements, e.g. multiple display units
• CPC Class Codes: H04B 1/707 : using direct sequence modulation
• CPC Class Codes: H04L 1/0071 : Use of interleaving interleaving per se H03M13/27

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 glucose monitoring device, comprising:

a glucose sensor, at least a portion of which is adapted for implantation and contact with bodily fluid, the glucose sensor producing a signal representative of a level of glucose in the bodily fluid; and

a transmitter coupled to the glucose sensor so that the transmitter converts the signal representative of the level of glucose in the bodily fluid into a digital signal representing the level of glucose in the bodily fluid, assembles a plurality of data words into a data message, at least one of the data words containing data derived from the digital signal representing the level of glucose in the bodily fluid, each of the data words comprising a set of bits, wherein for at least two of the data words, the set of bits are organized into a set of data bits and a set of error correction bits, and transmits the plurality of data words in an interleaving sequence, wherein the interleaving sequence includes transmitting a first bit in each of the set of bits of each of the data words of the data message followed by transmitting a second bit in each of the set of bits of each of the data words of the data message until the assembled plurality of data words are transmitted.

2. The device of claim 1, wherein the transmitter transmits each bit of each data word assembled into the data message starting with the least significant bit until the entire data message has been transmitted.

3. The device of claim 1, wherein the transmitter is further configured to transmit the data words of the data message at a predetermined transmission rate in the interleaving sequence to reduce error in the transmitted data message.

4. The device of claim 1, further including a processing unit operatively coupled to the transmitter.

5. The device of claim 1, further including a current to frequency conversion unit operatively coupled to the transmitter, the current to frequency conversion unit configured to receive the signal representative of the level of glucose in the bodily fluid.

6. The device of claim 1, wherein the transmitter is configured to transmit the data message to a remote location.

7. The device of claim 6, wherein the remote location includes one or more of a receiver device or a drug administration system.

8. The device of claim 7, wherein the transmitter is configured to transmit the data message using one or more of RF communication protocol, or infrared communication protocol.

9. The device of claim 1, wherein the transmitter is configured to transmit the data message using frequency modulation.

10. The device of claim 1, wherein the data message includes calibration data.

11. The device of claim 1, wherein the transmitter is configured to encrypt the data message.

12. The device of claim 1, wherein the glucose sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises a glucose-responsive enzyme and a mediator, wherein at least one of the glucose-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the glucose-responsive enzyme and the mediator is crosslinked with the polymer.

13. A method comprising:

collecting, using a glucose sensor, an analog signal representing a level of glucose in a bodily fluid;

converting, using a transmitter, the analog signal into a digital signal representing the level of glucose in the bodily fluid;

assembling, using the transmitter, a plurality of data words into a data message, at least one of the data words containing data derived from the digital signal representing the level of glucose in the bodily fluid, each of the data words comprising a set of bits, wherein for at least two of the data words, the set of bits are organized into a set of data bits and a set of error correction bits; and

transmitting, using the transmitter, the data message, such that the plurality of data words assembled into the data message are transmitted in an interleaving sequence, wherein the interleaving sequence includes transmitting a first bit in each of the set of bits of each of the data words of the data message followed by transmitting a second bit in each of the set of bits of each of the data words of the data message until the assembled plurality of data words are transmitted.

14. The method of claim 13, wherein each bit of each data word assembled into the data message is transmitted starting with the least significant bit until the entire data message has been transmitted.

15. The method of claim 13, further including transmitting the data message to a remote location.

16. The method of claim 13, further including transmitting the data message using one or more of RF communication protocol, or infrared communication protocol.

17. The method of claim 13, further including transmitting the data message based on frequency modulation.

18. The method of claim 13, wherein the data message includes calibration data.

19. The method of claim 13, further including encrypting the data message.

20. The method of claim 13, wherein the glucose sensor comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises a glucose-responsive enzyme and a mediator, wherein at least one of the glucose-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the glucose-responsive enzyme and the mediator is crosslinked with the polymer.