ANALYTE MONITORING DEVICE AND METHODS OF USE

• US 20070244380A1
• Filed: 06/21/2007
• Published: 10/18/2007
• 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: Friedman, Keith, Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Aria, Behrad, Tomasco, Michael, Vreeke, Mark, Colman, Fredric, Plante, Phillip
• Granted Patent: US 9,072,477 B2
• Time in Patent Office: Days
• US Class Current: 600/347
• 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 diabetes management device, comprising:

a housing;

a processor coupled to the housing and configured to process one or more glucose related signals detected by a glucose sensor; and

a display unit coupled to the housing and the processor to concurrently display at least two of the following;

glucose trend information, glucose value, rate that glucose is changing, a message.

2. The device of claim 1, wherein the display unit displays a graph.

3. The device of claim 2, wherein the graph is a glucose trend information.

4. The device of claim 2, wherein the graph is a rate of change of glucose graph.

5. The device of claim 1, wherein the glucose sensor is a sensor to be transcutaneously positioned in a user.

6. The device of claim 1, wherein the rate of glucose change comprises an indicator.

7. The device of claim 6, wherein the indicator comprises an arrow

8. The device of claim 6, wherein the indicator comprises more than one arrow.

9. The device of claim 6, wherein the indicator is color coded.

10. The device of claim 1, wherein the display unit is monochromatic.

11. The device of claim 1, wherein the display unit is polychromatic.

12. The device of claim 1, wherein the display comprises symbols.

13. The device of claim 1, wherein the processor is configured so that a particular display can be selected.

14. The device of claim 1, wherein the display unit displays at least three of the glucose trend information, the glucose value, the rate that glucose is changing, and the message.

15. The device of claim 1, wherein the display unit displays all of the glucose trend information, the glucose value, the rate that glucose is changing, and the message.

16. The device of claim 1, wherein the analyte value is displayed in a numeric value.

17. The device of claim 1, wherein the rate of change indicator includes one or more of an arrow, a composite indicator, a line graph, or a bar graph.

18. The device of claim 1, wherein the message includes one or more text messages.

19. The device of claim 18, wherein the one or more text messages includes glucose level management.

20. The device of claim 1, wherein the rate of glucose change display includes one or more graphs associated with the rate of change or acceleration in the rate of change of the glucose over a predetermined time period.

21. The device of claim 1, wherein the display unit includes an LED display.

22. The device of claim 1, wherein the display unit includes an LCD display

23. The device of claim 1, wherein the display unit includes a segmented display.

24. The device of claim 1, wherein the display unit includes a dot matrix display.

25. The device of claim 1 including a communication unit coupled to the processor to receive the one or more glucose related signals.

26. The device of claim 25, wherein the communication unit includes an rf transmitter.

27. The device of claim 25, wherein the communication unit includes an rf transceiver.

28. The device of claim 1 including a port for receiving a blood glucose test strip.

29. The device of claim 28, wherein the display unit is configured to display a blood glucose value associated with a test performed using a test strip received in the port.

30. The device of claim 29, wherein the port is provided on the housing.

31. The device of claim 1, wherein the device is integrated with an insulin administration unit.

32. A method, comprising:

providing a housing;

coupling a processor to the housing, the processor configured to process one or more glucose related signals detected by a glucose sensor; and

concurrently displaying, under the control of the processor, at least two of the following;

glucose trend information, glucose value, rate that glucose is changing, a message.

33. The method of claim 32 including displaying a graph.

34. The method of claim 33, wherein the graph is a glucose trend information.

35. The method of claim 33, wherein the graph is a rate of change of glucose graph.

36. The method of claim 32 including transcutaneously positioning at least a portion of the glucose sensor in a user.

37. The method of claim 32, wherein the rate of glucose change display comprises an indicator.

38. The method of claim 37, wherein the indicator comprises an arrow

39. The method of claim 37, wherein the indicator comprises more than one arrow.

40. The method of claim 37, wherein the indicator is color coded.

41. The method of claim 32 including displaying at least partially in monochromatic format.

42. The method of claim 32 including displaying at least partially in polychromatic format.

43. The method of claim 32 including displaying symbols.

44. The method of claim 32 including configuring the processor so that a particular display can be selected.

45. The method of claim 32 including displaying at least three of the glucose trend information, the glucose value, the rate that glucose is changing, and the message.

46. The method of claim 32 including displaying all of the glucose trend information, the glucose value, the rate that glucose is changing, and the message.

47. The method of claim 32, wherein the analyte value is displayed in a numeric value.

48. The method of claim 32, wherein the rate of glucose change display includes one or more of an arrow, a composite indicator, a line graph, or a bar graph.

49. The method of claim 32, wherein the message includes one or more text messages.

50. The device of claim 49, wherein the one or more text messages includes glucose level management.

51. The method of claim 32, wherein the rate of glucose change display includes one or more graphs associated with the rate of change or acceleration in the rate of change of the analyte over a predetermined time period.

52. The method of claim 32 including coupling a communication unit to the processor to receive the one or more analyte related signals.

53. The method of claim 52, wherein coupling the communication unit to the processor includes providing an rf transmitter.

54. The method of claim 52, wherein coupling the communication unit to the processor includes providing an rf transceiver.

55. The method of claim 32 including receiving a blood glucose test strip.

56. The method of claim 55 including displaying a blood glucose value associated with a test performed using the received test strip.

57. The method of claim 56 including providing a port on the housing, and further wherein the blood glucose test strip is received in the port.

58. The method of claim 32 including coupling an insulin administration unit to the housing.

59. An analyte monitoring device, comprising:

a housing;

a blood glucose meter coupled to the housing and including a strip port for receiving a test strip;

a processor coupled to the housing and configured to process one or more analyte related signals, the processor further coupled to the blood glucose meter for processing one or more signals related to the blood glucose level associated with the received test strip; and

a display unit coupled to the housing and the processor, the display unit for displaying a trend graph associated with the detected analyte related signals, an analyte value, a rate of change indicator associated with the rate of change of the analyte related signals, and an indication of the blood glucose level associated with the received test strip.

60. The device of claim 59, wherein the processor is configured to control a selective display of the one or more or more of the trend graph associated with the detected analyte related signals, the analyte value, the rate of change indicator associated with the rate of change of the analyte related signals, and the message.

61. The device of claim 59, wherein one or more of the analyte value and the blood glucose level is displayed in a numeric value.

62. The device of claim 59, wherein the rate of change indicator includes one or more of a directional arrow, a composite indicator, a line graph, and a bar graph.

63. The device of claim 59, wherein the rate of change indicator includes one or more graphs associated with the rate of change or acceleration in the rate of change of the analyte over a predetermined time period.

64. The device of claim 59, wherein at least two of the trend graph, the analyte value, the rate of change indicator, and the blood glucose level are concurrently displayed on the display unit.