Analyte Monitoring Device And Methods Of Use

• US 20100056890A1
• Filed: 11/09/2009
• Published: 03/04/2010
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Colman, Fredric C., Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Tomasco, Michael F.
• Granted Patent: US 8,265,726 B2
• Time in Patent Office: Days
• 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. A sensor control unit comprising:

an electrochemical sensor configured for at least partial implantation in the skin of a subject and comprising a working electrode on a distal end and a first conductive contact disposed on a proximal end thereof;

a mounting unit adapted for placement on the skin of the subject and to removably support a portion of the electrochemical sensor extending out of the skin of the subject; and

a housing comprising an rf transmitter disposed therein and a second conductive contact adapted to couple to the proximal portion of the sensor without intervening wires between the sensor and the housing, and adapted for coupling with the mounting unit.

2. The sensor control unit of claim 1, wherein the mounting unit adapted to removably support a portion of the electrochemical sensor extending out of the skin of the subject comprises a support structure for holding the sensor.

3. The sensor control unit of claim 1, wherein the mounting unit adapted to removably support a portion of the electrochemical sensor extending out of the skin of the subject comprises a support structure for holding the sensor against the second conductive contact.

4. The sensor control unit of claim 1, wherein coupling of the housing and the mounting unit establishes contact between the first conductive contact and the second conductive contact.

5. The sensor control unit of claim 1, further comprising adhesive for adhering the sensor control unit to skin.

6. The sensor control unit of claim 1, wherein the housing is adapted for placement substantially over an insertion site of the sensor.

7. The sensor control unit of claim 1, wherein the housing comprises an opening adapted for penetration by the sensor.

8. The sensor control unit of claim 1, wherein the housing is a single integral component.

9. The sensor control unit of claim 1, wherein the housing comprises two or more interlocking structures.

10. The sensor control unit of claim 9, wherein the interlocking structures are connected by a hinge.

11. The sensor control unit of claim 9, wherein the interlocking structures are configured to form a water resistant seal when coupled.

12. The sensor control unit of claim 1, wherein the housing is water resistant.

13. The sensor control unit of claim 1, further comprising a battery disposed in the housing.

14. The sensor control unit of claim 13, wherein the battery is sealed within the housing of the sensor control unit.

15. The sensor control unit of claim 13, wherein the battery is removable from the housing.

16. The sensor control unit of claim 1, wherein the second conductive contact is disposed on an interior surface of the housing.

17. The sensor control unit of claim 1, wherein the second conductive contact is disposed on an exterior surface of the housing.

18. The sensor control unit of claim 1, wherein the housing comprises guiding rails for positioning the sensor.

19. The sensor control unit of claim 1, wherein the second conductive contact comprises one or more pins.

20. The sensor control unit of claim 1, wherein the first conductive contact comprises a contact pad.

21. The sensor control unit of claim 1, wherein one of the first conductive contact and the second conductive contact is fabricated from a metal or alloy and one of the first conductive contact and the second conductive contact is fabricated from a non-metallic conductive material.

22. A method for monitoring a level of an analyte using the analyte monitoring system of claim 1, the method comprising:

mounting the mounting unit to the skin of the subject;

inserting the sensor into the skin of a subject such that a portion of the sensor extending out of the skin of the subject is removably supported by the mounting unit;

coupling the housing and the mounting unit such that the second conductive contact is coupled to the first conductive contact of the sensor;

collecting data, using the sensor control unit, regarding a level of an analyte from signals generated by the sensor; and

transmitting the collected data using the rf transmitter of the sensor control unit.

23. The method of claim 22, further comprising providing a support structure for holding the sensor.

24. The method of claim 22, further comprising providing a support structure for holding the sensor against the second conductive contact.

25. The method of claim 22, further comprising providing adhesive for adhering the sensor control unit to skin.

26. The method of claim 22, wherein mounting the mounting unit comprises mounting the mounting unit substantially over an insertion site of the sensor.

27. The method of claim 22, further comprising providing an opening in the mounting unit.

28. The sensor control unit of claim 24, wherein mounting the mounting unit comprises locating the opening substantially over an insertion site of the sensor.

29. The sensor control unit of claim 22, wherein coupling the housing and the mounting unit comprises coupling the first conductive contact and the second conductive contact without intervening wires.

30. The sensor control unit of claim 22, wherein one of the first conductive contact and the second conductive contact is fabricated from a metal or alloy and one of the first conductive contact and the second conductive contact is fabricated from a non-metallic conductive material.