Analyte monitoring device and methods of use
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.
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.