Analyte monitoring device and methods

• US 8,965,477 B2
• Filed: 04/14/2011
• Issued: 02/24/2015
• Est. Priority Date: 02/26/2009
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Hoss, Udo, Feldman, Benjamin J., Liu, Zenghe, Cho, Hyun, Rush, Benjamin M.
• Primary Examiner(s): D'ANGELO, MICHAEL J
• Application Number:
  US13/087,190
• Publication Number:
  US 20110257495A1
• Time in Patent Office: 1,412 Days
• Field of Search: 600345-347, 600/365
• US Class Current: 600/347
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation

Abstract

Method and system for determining real time analyte concentration including an analyte sensor having a portion in fluid contact with an interstitial fluid under a skin layer, an on-body electronics including a housing coupled to the analyte sensor and configured for positioning on the skin layer, the on-body electronics housing including a plurality of electrical contacts, on the housing; and a data analysis unit having a data analysis unit housing and a plurality of probes, on the housing. Each of the probes configured to electrically couple to a respective electrical contact when the data analysis unit is positioned in physical contact with the on-body electronics. The one or more signals on the probes correspond to one or more of a substantially real time monitored analyte concentration level (MACL), MACL over a predetermined time period, or a rate of change of the MACL, or combinations thereof, are provided.

Claims

1. A system for determining real time analyte concentration, comprising:

an analyte sensor having a portion in fluid contact with an interstitial fluid under a skin layer;

an on-body electronics including a housing coupled to the analyte sensor and configured for positioning on the skin layer, the on-body electronics housing including a plurality of electrical contacts provided on the housing; and

a data analysis unit having a data analysis unit housing and including a plurality of probes provided on the data analysis unit housing, each of the plurality of probes on the data analysis unit housing configured to electrically couple to the respective one of the plurality of the electrical contacts on the on-body electronics housing when the data analysis unit is positioned in physical contact with the on-body electronics;

wherein the on-body electronics comprise a first and second resistor-capacitor (RC) pair in series and electrically coupled to the analyte sensor such that a first voltage across the first RC pair represents a real-time current analyte concentration level, a second voltage across the second RC pair represents an average analyte concentration level over a period of time, and a difference between the first and second voltages represents a real-time trending of the analyte concentration level; and

wherein one or more signals on the plurality of probes on the data analysis unit housing comprises the first voltage and the second voltage and corresponds to one or more of a substantially real time monitored analyte concentration level, monitored analyte concentration level over a predetermined time period, or a rate of change of the monitored analyte concentration level, or one or more combinations thereof.

2. The system of claim 1, wherein the analyte sensor is a self powered sensor.

3. The system of claim 1, wherein the analyte sensor is a glucose sensor.

4. The system of claim 1, wherein the plurality of electrical contacts on the on-body electronics housing are concentrically positioned on the on-body electronics housing.

5. The system of claim 4, wherein each of the plurality of electrical contacts on the on-body electronics housing are spaced apart by a predetermined distance relative to each other.

6. The system of claim 1, wherein the data analysis unit includes one of a reader or a blood glucose meter.

7. The system of claim 1, wherein the data analysis unit includes an output unit to output one or more indications related to the one or more of the substantially real time monitored analyte concentration level, the monitored analyte concentration level over a predetermined time period, the rate of change of the monitored analyte concentration level, or one or more combinations thereof.

8. The system of claim 7, wherein the output unit includes one or more of a visual output unit, an audible output unit, or a vibratory output unit.

9. The system of claim 1, wherein the predetermined time period includes about three hours.

10. The system of claim 1, wherein the on-body electronics includes one or more data processing components to one or more filter, encode, store, analyze the one or more signals from the analyte sensor.

11. The system of claim 10, wherein the one or more data processing components determines a three hour trend information based on analyte concentration monitored by the analyte sensor.

12. The system of claim 1, wherein the data analysis unit calculates the difference between the first voltage and the second voltage to determine the real-time trending of the analyte concentration level.

13. The system of claim 12, wherein the data anlysis unit includes an output unit that outputs a first indication of the real-time current analyte concentration level and a second indication of the real-time trending of the analyte concentration level.

14. A method, comprising:

positioning a portion of an analyte sensor in fluid contact with an interstitial fluid under a skin layer;

positioning an on-body electronics including an on-body electronics housing coupled to the analyte sensor on the skin layer, the on-body electronics housing including a plurality of electrical contacts provided on the housing; and

contacting a plurality of probes provided on a data analysis unit housing to the respective one of the plurality of the electrical contacts on the on-body electronics housing to receive one or more analyte sensor related signals corresponding to one or more of a substantially real time monitored analyte concentration level, monitored analyte concentration level over a predetermined time period, or a rate of change of the monitored analyte concentration level, or one or more combinations thereof,

wherein the on-body electronics comprise a first and second resistor-capacitor (RC) pair in series and electrically coupled to the analyte sensor such that a first voltage across the first RC pair represents a real-time current analyte concentration level, a second voltage across the second RC pair represents an average analyte concentration level over a period of time, and a difference between the first and second voltages represents a real-time trending of the analyte concentration level; and

wherein the one or more analyte sensor related signals comprises the first voltage and the second voltage.

15. The method of claim 14, wherein the analyte sensor is a self powered sensor.

16. The method of claim 14, wherein the analyte sensor is a glucose sensor.

17. The method of claim 14, wherein the plurality of electrical contacts on the on-body electronics housing are concentrically positioned on the on-body electronics housing.

18. The method of claim 17, wherein each of the plurality of electrical contacts on the on-body electronics housing are spaced apart by a predetermined distance relative to each other.

19. The method of claim 14, wherein the data analysis unit includes one of a reader or a blood glucose meter.

20. The method of claim 14, comprising outputting one or more indications related to the one or more of the substantially real time monitored analyte concentration level, the monitored analyte concentration level over a predetermined time period, the rate of change of the monitored analyte concentration level, or one or more combinations thereof.

21. The method of claim 20, wherein outputting includes generating one or more visual, audible or vibratory output signals.

22. The method of claim 14, wherein the predetermined time period includes about three hours.

23. The method of claim 14, comprising one or more filtering, encoding, storing or analyzing the one or more signals from the analyte sensor.

24. The method of claim 23, comprising determining a three hour trend information based on analyte concentration monitored by the analyte sensor.

25. The method of claim 14, comprising calculating, with the data analysis unit, the difference between the first voltage and the second voltage to determine the real-time trending of the analyte concentration level.

26. The method of claim 25, comprising outputting a first indication of the real-time current analyte concentration level and a second indication of the real-time trending of the analyte concentration level.

27. An analyte monitoring system, comprising:

an on-body housing having a plurality of external electrical contacts;

a transcutaneous analyte sensor electrically coupled to the plurality of external electrical contacts and extending from the on-body housing;

a hand-held analyte measurement instrument having an instrument housing and a plurality of probes extending from the instrument housing, each of the plurality of probes on the instrument housing configured to electrically couple to a respective one of the plurality of the electrical contacts on the on-body housing when the hand-held analyte measurement instrument is positioned in physical contact with the on-body housing;

a temperature sensor unit coupled to the on-body housing or the hand-held analyte measuring instrument; and

an on-body electronics coupled to the housing and electrically coupled to the transcutaneous analyte sensor and the plurality of external electrical contacts;

wherein the on-body electronics comprise a first and second resistor-capacitor (RC) pair in series and electrically coupled to the transcutaneous analyte sensor such that a first voltage across the first RC pair represents a real-time current analyte concentration level, a second voltage across the second RC pair represents an average analyte concentration level over a period of time, and a difference between the first and second voltages represents a real-time trending of the analyte concentration level; and

wherein, when the hand-held analyte measurement instrument is positioned in physical contact with the on-body housing, the hand-held analyte measurement instrument receives the first voltage and second voltage via the plurality of probes.

28. The analyte monitoring system of claim 27, wherein the temperature sensor unit is a thermistor or thermocouple.

29. The analyte monitoring system of claim 28, wherein the hand-held analyte measurement instrument further includes a temperature measurement circuit to electrically couple with the thermistor/thermocouple when the hand-held analyte measurement instrument is positioned in physical contact with the on-body housing.

30. The analyte monitoring system of claim 27, wherein the temperature sensor is thermally connected to the skin through a thermally conductive pathway.

31. The analyte monitoring system of claim 30, wherein the hand-held analyte measurement instrument further includes an IR laser configured thermometer to shine on the thermally conductive pathway when the hand-held analyte measurement instrument is positioned in physical contact with the on-body housing.

32. The analyte monitoring system of claim 27, wherein the analyte sensor is a self-powered sensor.

33. The analyte monitoring system of claim 27, wherein the analyte sensor is a glucose sensor.

34. The analyte monitoring system of claim 27, wherein the analyte sensor is a ketone sensor.

35. The analyte monitoring system of claim 27, wherein the plurality of electrical contacts on the on-body housing are concentrically positioned on the on-body housing.

36. The analyte monitoring system of claim 27, wherein the on-body housing further includes a data processing component to filter, encode, store, or analyze a signal from the analyte sensor.

37. The analyte monitoring system of claim 36, wherein the data processing component determines trend information based on analyte concentration monitored by the analyte sensor.

38. The analyte monitoring system of claim 27, wherein a data analysis unit on the hand-held analyte measurement instrument calculates the difference between the first voltage and the second voltage to determine the real-time trending of the analyte concentration level.

39. The analyte monitoring system of claim 38, wherein the hand-held analyte measurement instrument outputs a first indication of the real-time current analyte concentration level and a second indication of the real-time trending of the analyte concentration level.

40. A method, comprising:

positioning an on-body housing on a skin surface;

implanting a portion of a transcutaneous analyte sensor under the skin surface below the on-body housing;

electrically coupling the analyte sensor to a plurality of electrical contacts provided on the on-body housing; and

providing a temperature sensor on the on-body housing;

providing a hand-held analyte measurement instrument having an instrument housing and a plurality of probes extending from the instrument housing, each of the plurality of probes configured to electrically couple to a respective one of the plurality of the electrical contacts on the on-body housing when the hand-held analyte measurement instrument is positioned in physical contact with the on-body housing;

contacting the plurality of probes to the respective plurality of the electrical contacts on the on-body housing to receive one or more analyte sensor related signals; and

coupling a temperature measurement circuit within the hand-held analyte measurement instrument with the temperature sensor on the on-body housing,

wherein on-body electronics are coupled to the housing and comprise a first and second resistor-capacitor (RC) pair in series and electrically coupled to the analyte sensor such that a first voltage across the first RC pair represents a real-time current analyte concentration level, a second voltage across the second RC pair represents an average analyte concentration level over a period of time, and a difference between the first and second voltages represents a real-time trending of the analyte concentration level, and the method comprises receiving the first voltage and the second voltage via the plurality of probes.

41. The method of claim 40, wherein the temperature sensor unit is a thermistor.

42. The method of claim 40, wherein the temperature sensor provides a thermally conductive pathway to the skin.

43. The method of claim 40, wherein the hand-held analyte measurement instrument further includes an IR laser configured to shine on the thermally conductive pathway to couple the temperature measurement circuit with the temperature sensor.

44. The method of claim 40, wherein the analyte sensor is a self-powered sensor.

45. The method of claim 40, wherein the analyte sensor is a glucose sensor.

46. The method of claim 40, wherein the analyte sensor is a ketone sensor.

47. The method of claim 40, wherein the plurality of electrical contacts on the on-body housing are concentrically positioned on the on-body housing.

48. The method of claim 40, wherein the on-body housing further includes a data processing component to filter, encode, store, or analyze a signal from the analyte sensor.

49. The method of claim 48, wherein the data processing component determines trend information based on analyte concentration monitored by the analyte sensor.

50. The method of claim 40, comprising calculating, with a data analysis unit on the hand-held analyte measurement instrument, the difference between the first voltage and the second voltage to determine the real-time trending of the analyte concentration level.

51. The method of claim 50, comprising outputting a first indication of the real-time current analyte concentration level and a second indication of the real-time trending of the analyte concentration level.