Infrared ATR glucose measurement system (II)

• US 6,424,851 B1
• Filed: 04/12/2000
• Issued: 07/23/2002
• Est. Priority Date: 10/13/1998
• Status: Expired due to Fees

• Current Assignee: Vivomedical, Inc. (Biotech-IgG Equity AB)
• Original Assignee: Medoptix Incorporated
• Inventors: Roe, Jeffrey N., Berman, Herbert L.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US09/547,433
• Time in Patent Office: 832 Days
• Field of Search: 600/309-310, 600/316, 600/322-324, 600/335, 356/39-42
• US Class Current: 600/322
• CPC Class Codes: A61B 2562/245 Means for cleaning the sensor in-situ or during use, e.g. hygienic wipes
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: G01N 21/552 Attenuated total reflection

Abstract

This involves a non-invasive glucose measurement device and a process for determining blood glucose level in the human body using the device. In typical operation, the glucose measurement device is self-normalizing in that it does not employ an independent reference sample in its operation. The device uses attenuated total reflection (ATR) infrared spectroscopy. Preferably, the device is used on a fingertip and compares two specific regions of a measured infrared spectrum to determine the blood glucose level of the user. Clearly, this device is especially suitable for monitoring glucose levels in the human body, and is especially beneficial to users having diabetes mellitus. The device and procedure may be used for other analyte materials which exhibit unique mid-IR signatures of the type described herein and that are found in appropriate regions of the outer skin.

Claims

1. An analyte level measurement device for measuring said analyte level in a human body by contacting a skin surface of the human body, comprising:

a.) an infrared source for emitting an IR beam into an ATR plate, said IR beam having components at least in the region of a referencing wavelength and a measuring wavelength,

b.) said ATR plate having a measurement surface for contact with said human skin surface and for directing said IR beam against said human skin surface,

c.) at least two IR sensors for simultaneously measuring absorbance of at least said referencing wavelength and said measuring wavelength, and

d.) a calculator for determining said analyte level using said measured absorbance of said skin surface.

2. The analyte measurement device of claim 1 wherein said ATR plate is configured to permit multiple internal reflections against said measurement surface prior to measuring said absorbance.

3. The analyte measurement device of claim 2 wherein said ATR plate is configured for 3-15 internal reflections against said measurement surface.

4. The analyte measurement device of claim 1 further comprising a pressure maintenance member for maintaining adequate pressure of said human skin surface against said ATR plate surface.

5. The analyte measurement device of claim 4 wherein said pressure maintenance member is configured to maintain a constant and above a selected minimum pressure of said human skin surface against said ATR plate surface.

6. The analyte measurement device of claim 1 further comprising a pressure measurement member situated to measure the pressure of said human skin surface against said ATR plate surface.

7. The analyte measurement device of claim 1 wherein said analyte is glucose and said referencing wavelength is between about 8.25 micrometers and about 8.75 micrometers.

8. The analyte measurement device of claim 1 wherein said analyte is glucose and said measuring wavelength is between about 9.50 micrometers and about 10.00 micrometers.

9. The analyte measurement device of claim 1 further comprising a beam splitter situated between said ATR plate and said at least two IR sensors to form two beams, said two beams for introduction each to one of said at least two IR sensors.

10. The analyte measurement device of claim 9 wherein

a.) a first of said at least two IR sensors measures said measuring wavelength and provides a measuring signal related to absorbance of said measuring wavelength; and

b.) a second of said at least two IR sensors measures said referencing wavelength and provides a referencing signal related to absorbance of said referencing wavelength.

11. The analyte measurement device of claim 1 wherein

a.) a first of said at least two IR sensors measures said measuring wavelength and provides a measuring signal related to absorbance of said measuring wavelength, and

b.) a second of said at least two IR sensors measures said referencing wavelength and provides a referencing signal related to absorbance of said referencing wavelength.

12. The analyte measurement device of claim 11 wherein said analyte is glucose and further comprising a comparator for comparing said measuring signal to said referencing signal and providing a signal indicative of blood glucose concentration.

13. The analyte measurement device of claim 12 further comprising a display for displaying said blood glucose concentration.

14. The analyte measurement device of claim 11 wherein said analyte is glucose and further comprising a computer component for comparing said measuring signal to said referencing signal and providing a digital signal indicative of blood glucose concentration.

15. The analyte measurement device of claim 14 further comprising a display for displaying said blood glucose concentration.

16. The analyte measurement device of claim 1 wherein said infrared source is a broadband source.

17. The analyte measurement device of claim 1 wherein said infrared source is a non-laser source.

18. The analyte measurement device of claim 1 wherein said infrared source comprises two selected wavelength lasers.

19. A method for determining the blood glucose level in a human being using a glucose measurement device, comprising the steps of

a.) contacting a skin surface on said human being with an ATR plate in said glucose measurement device, said ATR plate having a surface for contact with said human skin surface,

b.) irradiating said human skin surface with an IR beam having components at least in the region of a referencing wavelength and a measuring wavelength through said ATR plate to produce a reflected IR beam indicative of the blood glucose level in said human being, and

c.) detecting and quantifying said referencing wavelength and said measuring wavelength components in said reflected IR beam as emitted from said skin surface.

20. The method of claim 19 further comprising the step of maintaining said skin surface on said ATR plate at an adequate pressure.

21. The method of claim 19 further comprising the step of maintaining said skin surface on said ATR plate at a constant and above a selected minimum pressure.

22. The method of claim 19 further comprising the step of measuring the pressure of said skin surface on said ATR plate and maintaining said pressure at a relatively constant and above a selected minimum pressure.

23. The method of claim 19 further comprising the step of normalizing the glucose measurement device by simultaneously detecting and quantifying said referencing wavelength and said measuring wavelength components in said reflected IR beam prior to the step of contacting said skin surface on said human being to said ATR plate.

24. The method of claim 19 wherein said referencing wavelength is between about 8.25 micrometers and about 8.75 micrometers.

25. The method of claim 19 wherein said measuring wavelength is between about 9.50 micrometers and about 10.00 micrometers.

26. The method of claim 19 further comprising splitting said reflected beam to form two beams and introducing said two beams each to one of at least two IR sensors.

27. The method of claim 19 further comprising the steps of

a.) measuring the absorbance of said measuring wavelength in a first of at least two IR sensors and providing a measuring signal related to the absorbance of said measuring wavelength and

b.) measuring the absorbance of said referencing wavelength in a second of said at least two IR sensors and providing a referencing signal related to the absorbance of said referencing wavelength.

28. The method of claim 27 further comprising the steps of comparing said measuring signal to said referencing signal and providing a signal indicative of blood glucose concentration.

29. The method of claim 28 further comprising the step of calculating said blood glucose concentration using stored calibration constants.

30. The method of claim 29 further comprising the step of displaying said glucose concentration.

31. The method of claim 27 further comprising the steps of comparing said measuring signal to said referencing signal with a digital computer and providing a digital signal indicative of blood glucose concentration.

32. The method of claim 31 further comprising the step of calculating said blood glucose concentration using stored calibration constants.

33. The method of claim 32 further comprising the step of displaying said glucose concentration.

34. The method of claim 19 wherein said irradiating step comprises the step of actuating broadband infrared source.

35. The method of claim 19 wherein said irradiating step comprises the step of actuating a non-laser infrared source.

36. The method of claim 19 wherein said irradiating step comprises the step of actuating two selected wavelength lasers.

37. A method for determining the analyte level in a human being using an analyte measurement device, comprising the steps of

a.) contacting a skin surface on said human being with an ATR plate in said analyte measurement device, said ATR plate having a surface for contact with said human skin surface,

b.) irradiating said human skin surface with an IR beam having components at least in the region of,a referencing wavelength and a measuring wavelength through said ATR plate to produce a reflected IR beam indicative of the analyte level in said human being, and

c.) detecting and quantifying said referencing wavelength and said measuring wavelength components in said reflected IR beam as emitted from said skin surface.

38. The method of claim 37 further comprising splitting said reflected beam to form two beams and introducing said two beams each to one of at least two IR sensors.

39. The method of claim 38 further comprising the steps of

a.) measuring the absorbance of said measuring wavelength in a first of said at least two IR sensors and providing a measuring signal related to the absorbance of said measuring wavelength and

b.) measuring the absorbance of said referencing wavelength in a second of said at least two IR sensors and providing a referencing signal related to the absorbance of said referencing wavelength.

40. The method of claim 39 further comprising the steps of comparing said measuring signal to said referencing signal with a digital computer and providing a digital signal indicative of said analyte level.

41. The method of claim 40 further comprising the step of calculating said analyte level using stored calibration constants.

42. The method of claim 41 further comprising the step of displaying said analyte level.

43. The method of claim 37 further comprising the steps of comparing said measuring wavelength to said referencing signal and providing a wavelength indicative of said analyte level.

44. The method of claim 40 further comprising the step of calculating said analyte level using stored calibration constants.

45. The method of claim 44 further comprising the step of displaying said analyte level.

46. The method of claim 37 wherein said irradiating step comprises the step of actuating broadband infrared source.

47. The method of claim 37 wherein said irradiating step comprises the step of actuating a non-laser infrared source.

48. The method of claim 37 wherein said irradiating step comprises the step of actuating two selected wavelength lasers.

49. An in vivo method for determining the blood glucose level in a human being using a glucose measurement device, comprising the steps of:

a.) irradiating human skin surface with light containing at least a mid-IR component so to produce a reflected mid-IR beam from said skin surface indicative of the blood glucose level in said human being, and

b.) detecting and analyzing only said reflected mid-IR beam to determine said blood glucose level.

50. The method of claim 49 wherein said human skin has a stratum corneum and said mid-IR component does not penetrate below said stratum corneum.

51. The method of claim 49 wherein said human skin has a basal layer and said mid-IR component penetrates into said human skin only above said basal layer.

52. The method of claim 49 wherein said light containing at least a mid-IR component is of a strength such that it does not penetrate human skin to a depth sufficient to reach vascular structure.

53. The method of claim 49 wherein said reflected mid-IR beam has not penetrated said human skin to a depth sufficient to reach vascular structure.

54. The method of claim 49 wherein said reflected mid-IR beam contains at least a component wavelength between about 8.25 micrometers and about 8.75 micrometers.

55. The method of claim 49 wherein said reflected mid-IR beam contains at least a component wavelength between about 9.50 micrometers and about 10.00 micrometers.

56. A method for determining the blood glucose level in a human being using a glucose measurement device, comprising the steps of:

a.) irradiating a human body region substantially free of cholesterol, water, gamma globulin, albumin, and blood with light containing at least a mid-IR component so to produce a reflected mid-IR beam indicative of the blood glucose level in said human being, and

b.) detecting and analyzing said reflected mid-IR beam to determine said blood glucose level.

57. The method of claim 56 wherein said reflected mid-IR beam contains at least a component wavelength between about 8.25 micrometers and about 8.75 micrometers.

58. The method of claim 56 wherein said reflected mid-IR beam contains at least a component wavelength between about 9.50 micrometers and about 10.00 micrometers.