Non-invasive measurement system and method for measuring the concentration of an optically-active substance

• US 7,167,736 B2
• Filed: 11/04/2004
• Issued: 01/23/2007
• Est. Priority Date: 11/04/2004
• Status: Expired due to Fees

• Current Assignee: STI Medical Systems LLC
• Original Assignee: Q Step Technologies, Inc. (Science & Technology International, Inc.)
• Inventors: Winther, Dale E.
• Primary Examiner(s): Winakur; Eric
• Assistant Examiner(s): BERHANU, ETSUB D
• Application Number:
  US10/981,181
• Publication Number:
  US 20060094942A1
• Time in Patent Office: 810 Days
• Field of Search: 600/316, 600/317, 600/318, 600/319, 600/321, 600/323
• US Class Current: 600/319
• CPC Class Codes: A61B 5/14558 by polarisation

Abstract

A method and system for non-invasively measuring the concentration of an optically-active substance in a subject are provided. The system includes a light source adapted to transmit light towards a subject or object having a concentration of an optically-active substance, a polarizer positioned between the light source and the subject, an image capturing device, and a processor. The image capturing device is positioned to receive light reflected from the subject and create a measured image therefrom. The measured image defines measured light intensity data. The processor is configured to calculate a concentration of the optically-active substance based on a selected portion of the measured light intensity data.

Claims

1. An apparatus, comprising:

a. a light source adapted to transmit light towards an object containing a solution of an optically-active substance;

b. a polarizer, positioned between said light source and said object;

c. a first image capturing device, positioned to receive a portion of light reflected from said object and adapted to create a measured image therefrom, said measured image defining measured light intensity data;

d. a processor; and

e. a database, said database comprising predetermined concentration data for said optically-active substance and predetermined light intensity data, wherein said processor is further configured to calculate a concentration of said optically-active substance based on a selected portion of said measured light intensity data, a selected portion of said predetermined concentration data, and a selected portion of said predetermined light intensity data;

wherein said predetermined concentration data comprises one or more known concentration values and said predetermined light intensity data comprises one or more predetermined calculation space ratios.

2. The apparatus of claim 1, wherein said object is a human eye having an iris and said measured image comprises a measured image of said iris.

3. The apparatus of claim 1, further comprising a housing, wherein the light source, polarizer, first image capturing device and processor are contained in the housing.

4. The apparatus of claim 3, wherein the apparatus is a hand-held device.

5. The apparatus of claim 3, wherein the apparatus is a portable device.

6. The apparatus of claim 1, wherein said optically-active substance is glucose.

7. The apparatus of claim 1, further comprising a memory, wherein said database is stored in said memory.

8. The apparatus of claim 1 wherein said object is a human eye having an iris and said polarizer is positioned to transmit light from said light source towards said iris such that said transmitted light contacts said iris at one or more angles of incidence, thereby creating said portion of light reflected from said object.

9. The apparatus of claim 8, wherein at least one of said one or more angles of incidence is sufficient to cause polarization.

10. The apparatus of claim 8, wherein at least one of said one or more angles of incidence is Brewster'"'"'s angle.

11. The apparatus of claim 1, wherein said image capturing device is a charge coupled device.

12. The apparatus of claim 1, wherein said first image capturing device comprises a plurality of locations, said first image capturing device is adapted to measure the intensity of light received at each said location, thereby creating one or more measured intensities of said portion of light reflected from said object, and said processor is adapted to receive said one or more measured intensities of said portion of light reflected from said object, wherein said measured light intensity data comprises said one or more measured intensities of light reflected from said object.

13. The apparatus of claim 12, wherein said one or more measured intensities of light reflected from said object defines an array having one or more calculation spaces defined therein, each said calculation space having a plurality of measured light intensities defined therein, and wherein said selected portion of said measured light intensity data comprises at least one of said pluralities of measured light intensities in said one or more calculation spaces.

14. The apparatus of claim 13, wherein said processor is configured to calculate a calculation space ratio corresponding to each said calculation space, wherein said selected portion of said measured light intensity data comprises at least one of said calculation space ratios.

15. The apparatus of claim 14, wherein each said calculation space ratio comprises a ratio of measured light intensities in the corresponding calculation space.

16. The apparatus of claim 14, wherein said processor is further configured to calculate a first and second sum of measured light intensities in each said calculation space, wherein each said calculation space ratio comprises a ratio of said corresponding first sum and said corresponding second sum.

17. The apparatus of claim 16, wherein each said calculation space has a first length and a first width defining a first region therein and a second length and a second width defining a second region therein, wherein each said first sum comprises a sum of the measured light intensities in each said corresponding first region of said corresponding calculation space, and each said second sum comprises a sum of the measured light intensities in each said corresponding second region of said corresponding calculation space.

18. The apparatus of claim 13, wherein said one or more calculation spaces is four calculation spaces.

19. The apparatus of claim 13, wherein said one or more calculation spaces is two calculation spaces.

20. The apparatus of claim 1, wherein each said predetermined calculation space ratio comprises a predetermined ratio of light intensities, each said predetermined ratio of light intensities corresponds to a predetermined calculation space defined in an array of predetermined light intensities, and wherein each said predetermined light intensity in said array comprises an intensity of light measured at one of a plurality of locations defined by a second image capturing device.

21. The apparatus of claim 20, wherein said first image capturing device and said second image capturing device are the same device.

22. The apparatus of claim 20, wherein each said predetermined ratio of light intensities comprises a ratio of a first sum of said predetermined light intensities and a second sum of said predetermined light intensities, wherein both said first sum and said second sum correspond to the same predetermined calculation space to which said predetermined ratio of light intensities corresponds.

23. The apparatus of claim 22, wherein each said predetermined calculation space comprises a first region having a first length and a first width and a second region having a second length and a second width, wherein each said first sum of predetermined light intensities comprises a sum of the predetermined light intensities in each said first region and each said second sum comprises a sum of the predetermined light intensities in each said second region.

24. The apparatus of claim 1, wherein said object comprises a plurality of object regions, said predetermined concentration data comprises two or more known concentration values of said optically-active substance, and said predetermined light intensity data comprises a plurality of predetermined ratios of light intensities, each said predetermined ratio of light intensities corresponding to both one of said object regions and one of said known concentration values.

25. The apparatus of claim 24, wherein said object is an eye having an iris.

26. The apparatus of claim 24, wherein said light source and said polarizer are positioned to transmit light from said light source towards said plurality of object regions, such that said transmitted light contacts said plurality of object regions at one or more angles of incidence, thereby creating said portion of light reflected from said object, and said processor is configured to calculate at least one measured ratio of light intensities corresponding to each said object region from said portion of light reflected from said object.

27. The apparatus of claim 26, wherein at least one of said angles of incidence is sufficient to cause polarization.

28. The apparatus of claim 26, wherein at least one of said angles of incidence is Brewster'"'"'s angle.

29. The apparatus of claim 1, wherein said processor is configured to generate an offset error array.

30. The apparatus of claim 29, wherein said offset error array comprises a plurality of offset errors, each said offset error having an offset error array location defined by a row that corresponds to a known concentration of said optically-active substance and a column that corresponds to one of a plurality of iris regions of an eye.

31. The apparatus of claim 30, wherein each said offset error comprises the absolute value of the difference between a measured light intensity ratio and a predetermined light, intensity ratio, wherein both said measured light intensity ratio and said predetermined light intensity ratio correspond to the same iris region to which said offset error corresponds.

32. The apparatus of claim 31, wherein said processor is further configured to calculate a minimum offset error array.

33. The apparatus of claim 32, wherein said minimum offset error array comprises a plurality of minimum offset errors, each said minimum offset error corresponding to a row and a column of said offset error array, each said minimum offset error comprising the lowest offset error in the corresponding column of said offset error array such that each minimum offset error corresponds to one of said known concentration values and one of said iris regions.

34. The apparatus of claim 33, wherein said processor is further configured to calculate a cluster offset error sum for one or more clusters, each said cluster comprising a set of iris regions in said plurality of iris regions, each said cluster offset error sum comprising the sum of the minimum offset errors for each iris region comprising the cluster.

35. The apparatus of claim 34, wherein said processor is further configured to calculate a concentration of said optically-active substance by:

(i) selecting the cluster having the minimum cluster offset error sum among said one or more clusters, and (ii) averaging the known concentration values corresponding to the minimum offset errors for the iris regions comprising the selected cluster.

36. The apparatus of claim 1, wherein said light source is adapted to transmit light at a plurality of selected wavelengths.

37. The apparatus of claim 1, wherein said apparatus comprises a plurality of light sources, each of which is adapted to transmit light at one or more selected wavelengths.

38. The apparatus of claim 1, wherein said object is a human eye having an iris and a pupil within said iris, said iris comprising a plurality of iris regions, and said measured image comprises a measured image of said iris and a measured image of said pupil.

39. The apparatus of claim 38, wherein said plurality of iris regions comprises three or more iris regions.

40. The apparatus of claim 39, wherein said processor is adapted to calculate a plurality of measured light intensity ratios from said measured light intensity data, each said measured light intensity ratio corresponding to one of said plurality of iris regions, and wherein said selected portion of said measured light intensity data comprises at least one of said measured light intensity ratios.

41. The apparatus of claim 38, wherein said plurality of iris regions comprises four iris regions, each corresponding to an iris image region in said measured image of said iris, said four iris image regions defining first and second pairs of iris image regions, wherein each said pair of iris image regions defines a line through said pupil image.

42. The apparatus of claim 38, wherein each said iris region comprises a first and second rectangular regions, wherein each said first rectangular region defines first rectangular region measured light intensity data and wherein each said second rectangular region defines second rectangular region measured light intensity data, said processor is further configured to calculate a first sum of said first rectangular region measured light intensity data and a second sum of said second rectangular region measured light intensity data, and wherein each said measured light intensity ratio comprises a ratio of the first sum and the second sum corresponding to the same iris region to which said measured light intensity ratio corresponds.

43. The apparatus of claim 38, said apparatus further comprising a database operatively coupled to said processor, said database including an array of predetermined light intensity ratios, said array comprising a plurality of array locations, each said array location being defined by a row corresponding to a known concentration value for said optically-active substance and a column corresponding to one of said plurality of iris regions.

44. The apparatus of claim 43, wherein said processor is further configured to calculate a concentration of said optically-active substance according to the following method:

a. subdividing said array into a plurality of sub-arrays;

b. selecting a subarray based on at least one statistical confidence parameter;

c. defining a plurality of clusters, each said cluster comprising a set of iris regions from said plurality of iris regions;

d. selecting one of said plurality of clusters; and

e. calculating said concentration of an optically-active substance based on said selected cluster, said selected subarray and said measured light intensity data.

45. The apparatus of claim 43, wherein said at least one statistical confidence parameter is selected from the group consisting of an array deviation, a cluster sum deviation, a cluster proximity deviation, a cluster proximity deviation ratio, an array deviation ratio, a minimum offset error sum, a dispersion and a proximity Q factor.

46. The apparatus of claim 43, wherein said processor is further configured to calculate an offset error array.

47. The apparatus of claim 46, wherein said processor is adapted to calculate a plurality of measured light intensity ratios from said measured light intensity data, each said measured light intensity ratio corresponding to one of said iris regions, said offset error array comprises a plurality of offset error array locations, each said offset error array location being defined by a row that corresponds to one of said known concentration values and a column that corresponds to one of said iris regions.

48. The apparatus of claim 47, wherein each said offset error in said offset error array is generated according to the following steps:

a. selecting a known concentration value corresponding to one of said rows in said selected subarray;

b. selecting one of said iris regions; and

c. calculating the absolute value of the difference between the measured light intensity ratio corresponding to the selected iris region and the predetermined light intensity ratio corresponding to both the selected iris region and the selected known concentration value.

49. The apparatus of claim 47, wherein said processor is further configured to calculate a minimum offset error corresponding to each said iris region in said plurality of iris regions.

50. The apparatus of claim 49, wherein each said minimum offset error comprises the lowest offset error in the column of the offset error array which corresponds to the same iris region to which the minimum offset error corresponds.

51. The apparatus of claim 50, wherein said processor is further configured to calculate a cluster minimum offset error sum for each said cluster in said plurality of clusters.

52. The apparatus of claim 51, wherein each said cluster minimum offset error sum comprises the sum of the minimum offset errors for the iris regions comprising the cluster.

53. The apparatus of claim 52, wherein said step of selecting one of said plurality of clusters comprises selecting the cluster having the lowest cluster minimum offset error sum.

54. The apparatus of claim 53, wherein said step of calculating a concentration of said optically-active substance comprises averaging the known concentration values corresponding to the minimum offset errors of the iris regions comprising the selected cluster.

55. The apparatus of claim 1, wherein said processor is further configured to generate a plurality of rotated images from said measured image, thereby creating rotated image data, and wherein said processor is configured to calculate said concentration of said optically-active substance based on said rotated image data and said selected portion of measured light intensity data.

56. A method of calculating a concentration of an optically-active substance in an object containing a solution of said optically-active substance, the method comprising the steps of:

a. providing at least one measured image of said object, each said measured image defining an array of measured intensities of light reflected from said object;

b. calculating at least one ratio of measured light intensities from said array of measured intensities of light reflected from said object;

c. calculating a concentration of said optically-active substance based on said at least one ratio of measured intensities, wherein calculating said concentration of said optically-active substance based on said at least one ratio of measured intensities comprises;

(1) defining a plurality of calculation spaces in said measured image, each said calculation space defining a plurality of measured intensities of light; and

(2) calculating a calculation space ratio in each said calculation space, wherein said at least one ratio of measured light intensities comprises at least one of said calculation space ratios; and

d. displaying said calculated concentration.

57. The method of claim 56, wherein said object is a human eye having an iris.

58. The method of claim 56, wherein said step of calculating a calculation space ratio in each said calculation space comprises:

a. defining first and second regions in each said calculation space, wherein said first region defines a first region of measured light intensities and said second region defines a second region of measured light intensities;

b. calculating a sum of measured light intensities in said first region, thereby creating a first sum;

c. calculating a sum of measured light intensities in said second region, thereby creating a second sum; and

d. calculating a ratio of said first sum and said second sum.

59. The method of claim 56, wherein said plurality of calculation spaces comprises three or more calculation spaces.

60. The method of claim 56, wherein said plurality of calculation spaces comprises four calculation spaces.

61. The method of claim 60, wherein said measured image of an object comprises a measured image of an iris and a pupil, said four calculation spaces define first and second pairs of calculation spaces, and wherein each said pair of calculation spaces defines a line passing through said pupil image.

62. The method of claim 61, wherein each said first region of each said calculation space and each said second region of each said calculation space are rectangular in shape and positioned adjacent with respect to one another.

63. The method of claim 61, wherein each said first region of each said calculation space and each said second region of each said calculation space form an L-shape.

64. The method of claim 56, further comprising:

a. providing a plurality of predetermined images of a reference object, each said predetermined image corresponding to a known concentration of said optically-active substance and defining an array of predetermined intensities of light reflected from said object; and

b. calculating at least one predetermined ratio of intensities within each said array of predetermined intensities of light reflected from said reference object;

wherein said step of calculating a concentration of said optically-active substance comprises calculating a concentration of said optically-active substance based on said at least one ratio of measured intensities and said at least one predetermined ratio of intensities within each said array of predetermined intensities of light reflected from said reference object.

65. The method of claim 64, wherein said reference object is said object.

66. The method of claim 64, wherein said step of calculating at least one predetermined light intensity ratio within each said array of predetermined intensities of light reflected from said reference object comprises:

a. defining at least one predetermined calculation space in each said predetermined image; and

b. calculating a predetermined calculation space ratio in each said predetermined calculation space, wherein said at least one predetermined light intensity ratio comprises at least one of said predetermined calculation space ratios.

67. The method of claim 66, wherein said step of calculating a predetermined calculation space ratio in each said calculation space comprises:

a. defining a first predetermined region and a second predetermined region in each said predetermined calculation space, wherein said first predetermined region defines a first predetermined region of predetermined light intensities and said second predetermined region defines a second predetermined region of predetermined light intensities;

b. calculating a sum of predetermined intensities in said first predetermined region, thereby creating a first predetermined sum;

c. calculating a sum of predetermined intensities in said second predetermined region, thereby creating a second predetermined sum; and

d. calculating a ratio of said first predetermined sum and said second predetermined sum.

68. The method of claim 67, wherein said at least one predetermined calculation space comprises three or more calculation spaces.

69. The method of claim 67, wherein said at least one predetermined calculation spaces comprises four calculation spaces.

70. The method of claim 56, further comprising generating an offset error array.

71. The method of claim 70, wherein said offset error array comprises a plurality of offset errors, each said offset error having an offset error array location defined by a row that corresponds to one of a plurality of known concentration values of said optically-active substance and a column that corresponds to one of a plurality of iris regions of an eye.

72. The method of claim 71, wherein said offset error array comprises the absolute value of the difference between one of said at least one ratio of measured intensities and a predetermined light intensity ratio, wherein both said one of said at least one ratio of measured intensities and said predetermined light intensity ratio correspond to the same iris region to which said offset error corresponds.

73. The method of claim 72, further comprising generating a minimum offset error array.

74. The method of claim 73, wherein said minimum offset error array comprises a plurality of minimum offset errors, each said minimum offset error corresponding to a row and a column of said offset error array, each said minimum offset error comprising the lowest offset error in the corresponding column of said offset error array, whereby each said minimum offset error corresponds to one of said known concentration values and one of said iris regions.

75. The method of claim 74, further comprising:

a. defining a plurality of clusters, wherein each said cluster comprises a set of said iris regions;

b. calculating a sum of the minimum offset errors for the set of iris regions comprising each cluster;

c. selecting the cluster having the lowest sum of the minimum offset errors; and

d. averaging the known concentration values which correspond to the minimum offset errors for each iris region comprising the selected cluster.

76. The method of claim 56 wherein said at least one measured image of said object comprises a plurality of measured images, each said measured image corresponding to a different wavelength of light reflected from said object.

77. A method of calculating a concentration of an optically-active substance in an object containing a solution of said optically-active substance, the method comprising:

a. providing a measured image of said object, said measured image defining an array of measured intensities of light reflected from said object;

b. rotating said measured image to a plurality of rotational positions, wherein said plurality of rotational positions comprises 60 rotational positions, thereby generating a plurality of rotated measured intensities of light reflected from said object;

c. calculating a concentration of said optically-active substance based on said measured intensities of light reflected from said object and said rotated measured intensities of light reflected from said object; and

d. displaying said calculated concentration.

78. The method of claim 77, wherein said rotational positions are spaced apart from one another by about 0.1 degree.

79. The method of claim 77, wherein said plurality of rotated positions define a range of values from about −

3.0 degrees to about +3.0 degrees with respect to said measured image.

80. The method of claim 77 wherein said object is a human eye.

81. A method of calculating a concentration of an optically-active substance in an object containing a solution of said optically-active substance, said object including a plurality of object regions, the method comprising:

a. providing a plurality of measured intensity values of light reflected from said object, each said measured intensity value corresponding to one of said object regions;

b. providing a plurality of predetermined intensities of light reflected from a reference object containing a solution of said optically-active substance, said reference object including a plurality of reference object regions, and each said predetermined intensity of light corresponding to one of said reference object regions and to a known concentration of said optically-active substance;

c. selecting a portion of said plurality of predetermined intensities of light reflected from a reference object based on one or more statistical confidence parameters;

d. calculating a concentration of said optically-active substance in said object based on one or more of said measured intensities of light reflected from said object and said selected portion of said plurality of predetermined intensities of light reflected from a reference object; and

e. displaying said calculated concentration.

82. The method of claim 81, wherein said one or more statistical confidence parameters are selected from the group consisting of an array deviation, a cluster sum deviation, a cluster proximity deviation, an array deviation ratio, a cluster proximity deviation ratio, a dispersion, a proximity Q factor, and a minimum offset error sum.

83. The method of claim 81, wherein said object is a human eye.

84. The method of claim 81, wherein the reference object is the same as said object.

85. The method of claim 81, wherein said measured intensities of light reflected from said object correspond to a plurality of wavelengths of light.

86. A method of calculating the concentration of an optically-active substance in an object containing a solution of said substance, the method comprising:

a. providing a measured image of said object, said measured image defining measured light intensity data;

b. providing a plurality of predetermined images of a reference object containing a solution of said optically-active substance, each said predetermined image corresponding to a known concentration of said optically-active substance, said plurality of predetermined images defining an array of predetermined light intensity data, said array of predetermined light intensity data further defining a plurality of subarrays of predetermined light intensity data;

c. rotating said measured image to a plurality of rotational positions, thereby generating rotated light intensity data;

d. selecting one of said subarrays of predetermined light intensity data;

e. calculating the concentration of said optically-active substance in said object based on said measured light intensity data, said rotated light intensity data and said selected subarray of predetermined light intensity data; and

f. displaying said calculated concentration.

87. The method of claim 86, wherein said plurality of rotational positions comprises 60 rotational positions.

88. The method of claim 86, wherein said plurality of rotational positions range from about −

3 degrees to about +3 degrees from the orientation of the measured image.

89. The method of claim 86, wherein said plurality of rotational positions are spaced apart in increments of about 0.1 degree.

90. The method of claim 86, wherein said step of selecting a subarray is based on one or more statistical confidence parameters.

91. The method of claim 90, wherein said statistical confidence parameters are selected from the group consisting of an array deviation, a cluster sum deviation, a cluster proximity deviation, an array deviation ratio, a cluster proximity deviation ratio, a dispersion, a proximity Q factor, and a minimum offset error.

92. The method of claim 86, further comprising calculating an offset error array based on said measured light intensity data.

93. The method of claim 92, wherein said object comprises a plurality of object regions and said offset error array comprises a plurality of offset errors, each said offset error corresponding to one of said object regions.

94. The method of claim 93, wherein said plurality of object regions is two or more object regions.

95. The method of claim 93, wherein said plurality of object regions is four object regions.

96. The method of claim 95, wherein each said object region comprises first and second subregions, and wherein each said first subregion and second subregion are positioned with respect to one another such that they form an L-shape.

97. The method of claim 93, wherein said measured light intensity data comprises a plurality of measured light intensity values and said array of predetermined light intensity data comprises a plurality of predetermined light intensity values, and wherein each said offset error comprises the difference between a selected ratio of measured light intensity values from said plurality of measured light intensity values and a selected ratio of predetermined light intensity values from said selected plurality of predetermined light intensity values.

98. The method of claim 93, further comprising calculating at least one minimum offset error based on said offset error array, each said minimum offset error corresponding to one of said object regions and one of said known concentration values of said optically-active substance.

99. The method of claim 98, further comprising defining a plurality of clusters, each said cluster comprising a set of object regions, and selecting one of said clusters, wherein said step of calculating the concentration of said optically-active substance is further based on said selected cluster.

100. The method of claim 99, wherein said step of selecting one of said clusters comprises calculating the sum of the minimum offset errors for each of the object regions comprising each cluster and selecting the cluster having the lowest sum of the minimum offset errors.

101. The method of claim 100, wherein said step of calculating the concentration of said optically-active substance comprises averaging the known concentration values corresponding to the minimum offset errors of each of the object regions comprising the selected cluster.

102. The method of claim 86 wherein said object is an eye.

103. The method of claim 86, wherein said optically-active substance is glucose.

104. The method of claim 86, wherein said reference object is the same as said object.

105. A computer readable medium comprising instructions for calculating the concentration of an optically-active substance in an object containing a solution of said substance, the instructions comprising:

a. receiving a measured image of said object, said measured image defining measured light intensity data;

b. receiving a plurality of predetermined images of a reference object containing a solution of said optically-active substance, each said predetermined image corresponding to a known concentration of said optically-active substance, said plurality of predetermined images defining an array of predetermined light intensity data, said array of predetermined light intensity data further defining a plurality of subarrays of predetermined light intensity data;

c. rotating said measured image to a plurality of rotational positions, thereby generating rotated light intensity data;

d. selecting one of said subarrays of predetermined light intensity data; and

e. calculating the concentration of said optically-active substance in said object based on said measured light intensity data, said rotated light intensity data and said selected subarray of predetermined light intensity data.

106. An apparatus for calculating the concentration of an optically-active substance based on light reflected from an object containing a solution of said substance, the apparatus comprising:

a. a memory comprising predetermined concentration data and predetermined light intensity data;

b. means for capturing measured light intensity data for light reflected from said object; and

c. means for calculating a concentration of said optically-active substance based on said measured light intensity data, said predetermined concentration data and said predetermined light intensity data.

107. The apparatus of claim 106, further comprising a means for generating rotated image data.

108. The apparatus of claim 106, further comprising a means for selecting a portion of said predetermined concentration data based on one or more statistical confidence parameters.

109. The apparatus of claim 106, wherein said measured light intensity data corresponds to one or more wavelengths of light.