Reduction of errors in non-invasive tissue sampling

• US 20040204868A1
• Filed: 04/09/2003
• Published: 10/14/2004
• Est. Priority Date: 04/09/2003
• Status: Abandoned Application

• Current Assignee: Inlight Solutions, Inc.
• Original Assignee: Inlight Solutions, Inc.
• Inventors: Fleming, Cliona M., Maynard, John D., Hendee, Shonn P., Robinson, Mark Ries, Brown, Christopher D., Ridder, Trent D., Hull, Edward L., Vanslyke, Stephen J.
• Application Number:
  US10/410,006
• Publication Number:
  US 20040204868A1
• Time in Patent Office: Days
• US Class Current: 702/30
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/146 for optical coupling
• 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: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01N 21/49 within a body or fluid

Abstract

The present invention provides methods and devices for using feedback to improve non-invasive tissue measurements by making measurements faster, easier to perform, and less error prone. In some embodiments, a set of metrics is identified as measurable potential sources of measurement error that can be controlled by a user. In some embodiments, the set of metrics can be analyzed to determine which metrics are related to one another, and some possible error metrics can be discarded, and others used as surrogate metrics for measuring and monitoring measurement errors.

Claims

1. A method of acquiring a plurality of scans from a subject for use in a determination of a biological attribute, comprising:

a. Acquiring a spectrum, comprising a subset of the plurality of scans, from the subject;

b. Determining whether the spectrum is suitable for use in the determination, and, if so, indicating that the spectrum is suitable for use in the determination; and

c. Repeating steps a and b until the plurality of scans has been acquired.

2. A method as in claim 1, wherein the plurality of scans does not include any spectra not identified as suitable for use in the determination.

3. A method as in claim 1, wherein determining whether the spectrum is suitable comprises analyzing the spectrum for suitability.

4. A method as in claim 3, wherein determining whether the spectrum is suitable further comprises analyzing an auxiliary sensor.

5. A method as in claim 3, wherein analyzing the spectrum for suitability comprises analyzing the spectrum for the magnitude, variability, direction of variability, measure of dispersion, trend, or combination thereof, of a metric determined from the spectrum.

6. A method as in claim 5, wherein the metric comprises a mean water metric.

7. A method as in claim 6, wherein the mean water metric is derived from one or more of the dermal water value, peak to trough value, and path metrics.

8. A method as in claim 5, wherein the metric comprises a path stability metric.

9. A method as in claim 8, wherein the path stability metric is derived from one or more of the scatter offset standard deviation, and the dermal water standard deviation.

10. A method as in claim 5, wherein the metric comprises a contact metric.

11. A method as in claim 10, wherein the contact metric is derived from one or more of the specular value, path metrics, peak to trough value, and scatter slope.

12. A method as in claim 5, wherein the metric comprises an energy captured metric.

13. A method as in claim 12, wherein the energy captured metric is derived from one or more of the mean energy value, the scaled noise value, the out of band energy value, and the specular value.

14. A method as in claim 5, wherein the metric comprises an energy stability metric.

15. A method as in claim 14, wherein the energy stability metric is derived from one or more of the scan change value, the absorbance variance, and the cepstrum values.

16. A method as in claim 5, wherein the measure of dispersion comprises standard deviation, mean absolute deviation, median absolute deviation, or interquartile range.

17. A method of acquiring a spectrum from a subject for use in determination of a biological attribute, comprising:

a. Acquiring a spectrum from the subject;

b. Determining whether a subject-affected characteristic of the spectrum acquisition is likely to affect the accuracy of the determination, and, if so, communicating information to the subject that allows the subject to affect the characteristic.

18. A method as in claim 17, further comprising repeating steps a and b until step b indicates that the characteristic is unlikely to cause an error in the determination.

19. A method as in claim 17, wherein determining whether a subject-affected characteristic of the spectrum acquisition is likely to affect the accuracy of the determination comprises analyzing the spectrum for the magnitude, variability, direction of variability, measure of dispersion, trend, or combination thereof, of a metric determined from the spectrum

20. A method as in claim 19, wherein the spectrum comprises a plurality of scans, and wherein analyzing the spectrum comprises comparing a first scan within the spectrum with a second scan within the spectrum.

21. A method as in claim 19, wherein analyzing the spectrum comprises determining a metric from the data in the spectrum, and comparing the metric with a predetermined value.

22. A method as in claim 21, wherein the metric comprises a mean water metric.

23. A method as in claim 22, wherein the mean water metric is derived from one or more of the dermal water value, peak to trough value, and path metrics.

24. A method as in claim 21, wherein the metric comprises a path stability metric.

25. A method as in claim 24, wherein the path stability metric is derived from one or more of the scatter offset standard deviation, and the dermal water standard deviation.

26. A method as in claim 21, wherein the metric comprises a contact metric.

27. A method as in claim 26, wherein the contact metric is derived from one or more of the specular value, path metrics, peak to trough value, and scatter slope.

28. A method as in claim 21, wherein the metric comprises an energy captured metric.

29. A method as in claim 28, wherein the energy captured metric is derived from one or more of the mean energy value, the scaled noise value, the out of band energy value, and the specular value.

30. A method as in claim 21, wherein the metric comprises an energy stability metric.

31. A method as in claim 30, wherein the energy stability metric is derived from one or more of the scan change value, the absorbance variance, and the cepstrum values.

32. A method as in claim 19, wherein the spectrum comprises a plurality of scans, and wherein analyzing the spectrum comprises determining a measure of dispersion of the plurality of scans.

33. A method as in claim 32, wherein the measure of dispersion comprises standard deviation, mean absolute deviation, median absolute deviation, or interquartile range.

34. A method as in claim 19, wherein the spectrum comprises a plurality of scans, and wherein analyzing the spectrum comprises determining a trend of a metric determined from the data in the plurality of scans.

35. A method of determining a biological attribute of tissue of a subject, comprising:

a. Acquiring a spectrum of the tissue;

b. Determining a plurality of metrics from the spectrum;

c. Determining whether any of the determined metrics indicate a likelihood of error in an attribute determination using the spectrum, and, if so, identifying the spectrum as not-to-be-used, if not, identifying the spectrum as to-be-used;

d. Determining whether any of the determined metrics indicate that a subject action is likely to affect the value of a metric and, if so, communicating information to the subject that allows the subject to perform such action;

e. Repeating steps a, b, c, and d until a terminal condition is reached;

f. Determining the biological attribute using a multivariate model applied to the spectra identified as to-be-used.

36. A method as in claim 35, wherein the terminal condition comprises acquisition of a desired number of spectra identified as to-be-used.

37. A method as in claim 35, wherein the terminal condition comprises lapse of a selected time.

38. A method as in claim 35, wherein the terminal condition depends on at least one of the determined metrics.

39. A method as in claim 35, wherein the spectrum comprises a plurality of scans, and wherein analyzing the spectrum comprises comparing a first scan within the spectrum with a second scan within the spectrum.

40. A method as in claim 35, wherein at least one of the plurality of metrics comprises a mean water metric.

41. A method as in claim 40, wherein the mean water metric is derived from one or more of the dermal water value, peak to trough value, and path metrics.

42. A method as in claim 35, wherein at least one of the plurality of metrics comprises a path stability metric.

43. A method as in claim 42, wherein the path stability metric is derived from one or more of the scatter offset standard deviation, and the dermal water standard deviation.

44. A method as in claim 35, wherein at least one of the plurality of metrics comprises a contact metric.

45. A method as in claim 44, wherein the contact metric is derived from one or more of the specular value, path metrics, peak to trough value, and scatter slope.

46. A method as in claim 35, wherein at least one of the plurality of metrics comprises an energy captured metric.

47. A method as in claim 46, wherein the energy captured metric is derived from one or more of the mean energy value, the scaled noise value, the out of band energy value, and the specular value.

48. A method as in claim 35, wherein at least one of the plurality of metrics comprises an energy stability metric.

49. A method as in claim 47, wherein the energy stability metric is derived from one or more of the scan change value, the absorbance variance, and the cepstrum values.

50. A method as in claim 35, wherein the spectrum comprises a plurality of scans, and wherein analyzing the spectrum comprises determining a measure of dispersion of the plurality of scans.

51. A method as in claim 50, wherein the measure of dispersion comprises standard deviation, mean absolute deviation, median absolute deviation, or interquartile range.

52. A method as in claim 35, wherein the spectrum comprises a plurality of scans, and wherein analyzing the spectrum comprises determining a trend of a metric determined from the data in the plurality of scans.

53. A method as in claim 35, wherein the metrics comprise a metric correlated with the contribution of another substance to the spectrum, and wherein communicating information comprises communicating information regarding the presence of the other substance if the metric so indicates.

54. A method as in claim 35, wherein communicating information comprises providing a text display accessible by the subject.

55. A method as in claim 35, wherein communicating information comprises providing a graphic display accessible by the subject.

56. A method as in claim 35, wherein the metrics comprise a metric correlated with the stability of an interface between the tissue and a spectrum acquisition instrument.

57. A method as in claim 35, wherein communicating information comprises providing a sound audible to the subject.

58. A method as in claim 35, wherein communicating information comprises providing words audible to the subject.

59. A method as in claim 35, wherein the metrics comprise a metric correlated with one or more of:

placement of a spectrum acquisition sensor with respect to the tissue, cleanliness of an interface between the tissue and a spectrum acquisition instrument, steadiness of the placement of a spectrum acquisition sensor with respect to the tissue, the type of tissue analyzed, characteristics of a medium disposed between a spectrum acquisition sensor and the tissue, temperature, existence of extraneous substances in or near the interface between the tissue and a spectrum acquisition instrument, the angle at which the interface between the tissue and a spectrum acquisition instrument occurs with respect to the tissue, and variations in the distance between a spectrum acquisition sensor and the tissue.

60. A method of determining user-interactive metrics relating to spectra used in determining biological attributes in a system interacting with a user, comprising:

a. Determining a plurality of initial metrics determinable from information in a spectrum;

b. Selecting a plurality of preferred metrics as those initial metrics whose values are related to improved performance of the determination method;

c. Associating a user interaction with at least some of the preferred metrics, where the user interaction comprises information related to actions of a user that are related to the associated metric.

61. A method as in claim 60, wherein selecting a plurality of preferred metrics comprises identifying and combining preferred metrics whose combination is related to improved performance of the determination method.

62. A method as in claim 60, wherein the user interaction comprises information to be communicated to the user that allows the user to affect the metric.

63. An apparatus for determining a biological attribute of tissue, comprising:

a. A spectrum acquisition system;

b. A metric determination system, responsive to spectra acquired by the spectrum acquisition system;

c. A user interaction system, responsive to the metric determination system;

d. An attribute determination system, comprising a multivariate model and responsive to the spectrum acquisition system.

64. An apparatus as in claim 63, wherein the metric determination system comprises means for analyzing the spectrum for the magnitude, variability, direction of variability, measure of dispersion, trend, or combination thereof, of a metric determined from the spectrum.

65. An apparatus as in claim 63, wherein the metric determination system comprises means for analyzing the spectrum to determine a mean water metric.

66. An apparatus as in claim 63, wherein the metric determination system comprises means for analyzing the spectrum to determine a path stability metric.

67. An apparatus as in claim 63, wherein the metric determination system comprises means for analyzing the spectrum to determine a contact metric.

68. An apparatus as in claim 63, wherein the metric determination system comprises means for analyzing the spectrum to determine an energy captured metric.

69. An apparatus as in claim 63, wherein the metric determination system comprises means for analyzing the spectrum to determine an energy stability metric.

70. An apparatus as in claim 63, wherein the spectrum acquisition system comprises a cradle adapted to receive a human forearm, the cradle having an optical interface adapted to acquire a spectrum from forearm tissue placed in proximity thereto.

71. An apparatus as in claim 63, wherein the user interaction system comprises an audio output device and a plurality of audio signals associated with information from the metric determination system.

72. An apparatus as in claim 63, wherein the user interaction system comprises a display whose visible appearance is changeable responsive to information from the metric determination system.

73. An apparatus as in claim 72, wherein the display comprises a status light, a text display, a bar graph display, a dial display, or a combination thereof.