Analyte Monitoring Device And Methods Of Use

• US 20100069729A1
• Filed: 11/09/2009
• Published: 03/18/2010
• Est. Priority Date: 04/30/1998
• Status: Active Grant

• Current Assignee: Adam Heller, Behrad Aria, Ephraim Heller, Fredric C. Colman, James Say, Keith A. Friedman, Mark S. Vreeke, Michael F. Tomasco, Phillip John Plante, Yoram Gal
• Original Assignee: Adam Heller, Behrad Aria, Ephraim Heller, Fredric C. Colman, James Say, Keith A. Friedman, Mark S. Vreeke, Michael F. Tomasco, Phillip John Plante, Yoram Gal
• 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 8,175,673 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 method of using an electrochemical sensor, the method comprising:

adhering a mounting unit to a skin of a subject;

after adhering the mounting unit to the skin of the subject, advancing the electrochemical sensor into the skin of the subject using the inserter;

removing the inserter;

mounting a housing of a sensor control unit to the mounting unit; and

coupling at least one conductive contact disposed on the housing with at least one conductive contact of the electrochemical sensor.

2. The method of claim 1, wherein the at least one conductive contact disposed on the housing and the at least one conductive contact of the electrochemical sensor are coupled when the housing is mounted on the mounting unit.

3. The method of claim 1, further comprising applying a skin protecting material to the skin prior to adhering the mounting unit.

4. The method of claim 1, wherein the electrochemical sensor is disposed in a sharp, rigid insertion member of the inserter, the sensor being released from the inserter after insertion.

5. The method of claim 4, wherein the insertion member comprises a substantially U-shaped profile to at least partially support the sensor.

6. The method of claim 4, wherein the insertion member comprises a substantially V-shaped profile to at least partially support the sensor.

7. The method of claim 1, wherein inserting an electrochemical sensor into the skin of the subject by using the inserter comprises providing a force against the inserter to advance the sensor into the skin of the subject.

8. The method of claim 7, wherein a force applied to the inserter is applied manually.

9. The method of claim 7, wherein a force applied to the inserter is applied mechanically.

10. The method of claim 9, wherein a force applied to the inserter is applied by a spring.

11. The method of claim 7, wherein a force applied to the inserter is applied by compressed gas.

12. The method of claim 7, wherein a force applied to the inserter is applied electromagnetically.

13. The method of claim 1, wherein inserting an electrochemical sensor into the skin of the subject by using the inserter comprises providing a force to the sensor to advance the sensor into the skin, while the inserter remains stationary and supports the sensor.

14. The method of claim 13, wherein a force applied to the sensor is applied mechanically.

15. The method of claim 14, wherein a force applied to the sensor is applied by a spring.

16. The method of claim 13, wherein a force applied to the sensor is applied by compressed gas.

17. The method of claim 7, wherein a force applied to the inserter is applied electromagnetically.

18. The method of claim 1, wherein removing the inserter comprises removing the inserter from the skin of the subject.

19. The method of claim 18, wherein removing the inserter from the skin of the subject comprises removing the inserter by use of a spring.

20. The method of claim 18, wherein removing the inserter from the skin of the subject comprises removing the inserter electromagnetically.

21. The method of claim 1, wherein mounting a housing of a sensor control unit to the mounting unit adhered to the skin of the subject comprises mating a portion of the sensor control unit with a portion of the mounting unit.

22. The method of claim 21, wherein coupling the at least one conductive contact disposed on the housing with at least one conductive contact disposed on the electrochemical sensor comprises coupling the at least one conductive contact disposed on the housing with at least one conductive contact of the electrochemical sensor upon mating the portion of the mounting unit with a portion of the sensor control unit.

23. The method of claim 1, further comprising, after coupling the at least one conductive contact disposed on the housing with at least one conductive contact disposed on the electrochemical sensor, activating the sensor control unit.

24. A method of using an electrochemical sensor, the method comprising:

aligning an inserter with a portion of a mounting unit, the inserter configured to carry an electrochemical sensor therewith;

adhering a mounting unit to a skin of a subject;

advancing the electrochemical sensor into the skin of the subject relative to the mounting unit using the inserter;

removing the inserter;

mounting a housing of a sensor control unit to the mounting unit; and

coupling at least one conductive contact disposed on the housing with at least one conductive contact of the electrochemical sensor.

25. The method of claim 24, wherein the at least one conductive contact disposed on the housing and the at least one conductive contact of the electrochemical sensor are coupled when the housing is mounted to the mounting unit.

26. The method of claim 24, further comprising applying a skin protecting material to the skin prior to adhering the mounting unit.

27. The method of claim 24, wherein the electrochemical sensor is disposed in a sharp, rigid insertion member of the inserter, the sensor being released from the inserter after insertion.

28. The method of claim 27, wherein the insertion member comprises a substantially U-shaped profile to at least partially support the sensor.

29. The method of claim 27, wherein the insertion member comprises a substantially V-shaped profile to at least partially support the sensor.

30. The method of claim 24, wherein inserting an electrochemical sensor into the skin of the subject by using the inserter comprises providing a force against the inserter to advance the sensor into the skin of the subject.

31. The method of claim 30, wherein a force applied to the inserter is applied manually.

32. The method of claim 30, wherein a force applied to the inserter is applied mechanically.

33. The method of claim 32, wherein a force applied to the inserter is applied by a spring.

34. The method of claim 30, wherein a force applied to the inserter is applied by compressed gas.

35. The method of claim 30, wherein a force applied to the inserter is applied electromagnetically.

36. The method of claim 24, wherein inserting an electrochemical sensor into the skin of the subject by using the inserter comprises providing a force to the sensor to advance the sensor into the skin, while the inserter remains stationary and supports the sensor.

37. The method of claim 36, wherein a force applied to the sensor is applied mechanically.

38. The method of claim 37, wherein a force applied to the sensor is applied by a spring.

39. The method of claim 36, wherein a force applied to the sensor is applied by compressed gas.

40. The method of claim 36, wherein a force applied to the inserter is applied electromagnetically.

41. The method of claim 24, wherein removing the inserter comprises removing the inserter from the skin of the subject.

42. The method of claim 41, wherein removing the inserter from the skin of the subject comprises removing the inserter by use of a spring.

43. The method of claim 41, wherein removing the inserter from the skin of the subject comprises removing the inserter electromagnetically.

44. The method of claim 24, wherein mounting a housing of a sensor control unit to the mounting unit comprises mating a portion of the sensor control unit with a portion of the mounting unit.

45. The method of claim 44, wherein coupling the at least one conductive contact disposed on the housing with at least one conductive contact disposed on the electrochemical sensor comprises coupling the at least one conductive contact disposed on the housing with at least one conductive contact of the electrochemical sensor upon mating the portion of the mounting unit with a portion of the sensor control unit.

46. The method of claim 24, further comprising, after coupling the at least one conductive contact disposed on the housing with at least one conductive contact disposed on the electrochemical sensor, activating the sensor control unit.