Analyte monitoring device and methods of use

• US 8,391,945 B2
• Filed: 03/17/2009
• Issued: 03/05/2013
• Est. Priority Date: 04/30/1998
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Say, James, Tomasco, Michael F., Heller, Adam, Gal, Yoram, Aria, Behrad, Heller, Ephraim, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Colman, Fredric C.
• Primary Examiner(s): Natnithithadha, Navin
• Application Number:
  US12/405,643
• Publication Number:
  US 20090177057A1
• Time in Patent Office: 1,449 Days
• Field of Search: 600/309, 600345-366
• US Class Current: 600/345
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• 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 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• 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 5/14503 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 5/1486 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 5/72 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: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• 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: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: C12Q 1/54 : involving glucose or galactose
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: H01L 23/3107 : the device being completely enclosed
• CPC Class Codes: H01L 23/49548 : Cross section geometry H01L23/49562 takes precedence
• CPC Class Codes: H01L 2924/00 : Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/0002 : Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H01L 2924/19041 : being a capacitor
• CPC Class Codes: H01L 2924/3011 : Impedance
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49124 : On flat or curved insulated base, e.g., printed circuit, etc.

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. An electrochemical biosensor assembly, at least a portion of which is configured to be positioned beneath a skin surface of a user, comprising:

a mounting unit configured to adhere to the skin surface of the user;

a housing unit; and

a biosensor configured to couple with the housing unit, the biosensor including a substrate having a first surface and a second surface, and at least one electrode formed on the substrate;

wherein the biosensor includes a portion configured to connect with the housing unit, the portion of the biosensor configured to connect with the housing unit maintained at a first predetermined angle relative to the skin surface, the portion of the biosensor configured to be positioned beneath the skin surface maintained at a second predetermined angle relative to the skin surface, the flexibility of the biosensor varying along a continuum and the biosensor is bent; and

wherein the biosensor is configured to advance through the mounting unit after the mounting unit is adhered to the skin surface of the user, the biosensor is further configured to connect with the housing unit after the portion of the biosensor is positioned beneath the skin surface of the user, and a conductive contact of the biosensor is configured to couple with at least one conductive contact disposed on the housing unit.

2. The biosensor assembly of claim 1 wherein the at least one electrode includes a carbon compound.

3. The biosensor assembly of claim 2 wherein the at least one electrode includes carbon.

4. The biosensor assembly of claim 2 wherein the at least one electrode includes a first electrode and a second electrode each including carbon.

5. The biosensor assembly of claim 4 wherein the first and second electrodes are formed on the same surface of the substrate.

6. The biosensor assembly of claim 4 including a third electrode formed on the substrate.

7. The biosensor assembly of claim 6 wherein the first electrode and the second electrode are formed on the first surface of the substrate, and the third electrode is formed on the second surface of the substrate.

8. The biosensor assembly of claim 1 including an enzyme on the at least one electrode.

9. The biosensor assembly of claim 8 wherein the enzyme includes glucose oxidase or glucose dehydrogenase.

10. The biosensor assembly of claim 8 including a redox compound present with the enzyme.

11. The biosensor assembly of claim 10 wherein the redox compound includes a redox polymer.

12. The biosensor assembly of claim 1 wherein the biosensor is configured to operate over a period of at least seven days.

13. The biosensor assembly of claim 1 wherein the biosensor is configured to provide one or more signals to the housing unit.

14. The biosensor assembly of claim 1 wherein the at least one conductive contact disposed on the housing unit and the at least one conductive contact of the biosensor are configured to couple when the housing unit is mounted to the mounting unit.

15. The biosensor assembly of claim 1 wherein the biosensor is disposed in a sharp, rigid insertion member of an inserter, the biosensor is configured to release from the inserter after being positioned beneath the skin surface of the user.

16. The biosensor assembly of claim 1 wherein the biosensor is configured to be positioned beneath the skin surface of the user by providing a force against the inserter to advance the sensor beneath the skin of the user.

17. An analyte biosensor assembly, comprising:

a mounting unit configured to adhere to a skin surface of a user;

a housing unit; and

a biosensor configured to couple with the housing unit, the biosensor including a substrate, and a first electrode and a second electrode provided on the substrate;

wherein at least a portion of the biosensor is configured to connect to the housing unit to receive analyte related data from the biosensor, the portion of the biosensor configured to connect to the housing unit maintained at a first predetermined angle relative to the skin surface, and at least a portion of the biosensor is configured to be positioned beneath the skin surface and is maintained at a second predetermined angle relative to the skin surface;

wherein the flexibility of the biosensor varies along a continuum and the biosensor is bent; and

wherein the biosensor is configured to advance through the mounting unit after the mounting unit is adhered to the skin surface of the user, the biosensor is further configured to connect with the housing unit after the portion of the biosensor is positioned beneath the skin surface of the user, and a conductive contact of the biosensor is configured to couple to at least one conductive contact disposed on the housing unit.

18. The biosensor assembly of claim 17 wherein the biosensor is configured to provide one or more signals to the housing unit.

19. The biosensor assembly of claim 17 wherein the biosensor is configured to provide the one or more signals to the housing unit, the housing unit configured for wireless transmission of the received analyte related data from the biosensor to a remote location.

20. The biosensor assembly of claim 17 wherein the at least one conductive contact disposed on the housing unit and the at least one conductive contact of the biosensor are configured to couple when the housing unit is mounted to the mounting unit.

21. The biosensor assembly of claim 17 wherein the biosensor is disposed in a sharp, rigid insertion member of an inserter, the biosensor is configured to release from the inserter after being positioned beneath the skin surface of the user.