Method and system for determining bilirubin concentration

• US 6,882,873 B2
• Filed: 11/26/2002
• Issued: 04/19/2005
• Est. Priority Date: 01/17/1996
• Status: Expired due to Term

• Current Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Original Assignee: Respironics Incorporated
• Inventors: Xu, Fan, Newman, Gregory J., Eppstein, Jonathan A., Ignotz, Keith D., Samuels, Mark A.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): Kremer, Matthew J
• Application Number:
  US10/303,832
• Publication Number:
  US 20030109773A1
• Time in Patent Office: 875 Days
• Field of Search: 600309-310, 600/322, 600/315
• US Class Current: 600/315
• CPC Class Codes: A61B 2560/0233 Optical standards
• CPC Class Codes: A61B 2562/247 Hygienic covers, i.e. for covering the sensor or apparatus during use
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence

Abstract

A system and method embodying the invention can be used to detect a characteristic or condition of a patient. A method embodying the invention may include the steps of illuminating a portion of a skin of the patient with light, detecting a frequency spectrum of light scattered from the skin, determining, from first and second portions of the spectrum, a first parameter indicative of a blood content of the skin and a second parameter indicative of a melanin content of the skin, determining, from a third portion of the spectrum, a third parameter indicative of an uncorrected bilirubin concentration, and calculating a corrected bilirubin concentration based on the first, second and third parameters.

Claims

1. A method for determining a bilirubin concentration of a patient, comprising the steps of:

a) illuminating a portion of a skin of the patient with light;

b) detecting a frequency spectrum of light scattered from the skin;

c) determining, from first and second portions of the spectrum, a first parameter indicative of a blood content of the skin and a second parameter indicative of a melanin content of the skin;

d) determining, from a third portion of the spectrum, a third parameter indicative of an uncorrected bilirubin concentration; and

e) calculating a corrected bilirubin concentration based on at least one calibration factor corresponding to at least one of the first, second, and third parameters and values consisting essentially of the first, second and third parameters.

2. The method of claim 1, further comprising the step of performing a calibration measurement on a calibration target and storing resulting calibration data prior to illuminating the patient'"'"'s skin with light, wherein the at least one calibration factor included in the step of calculating a corrected bilirubin concentration is based on the calibration data.

3. The method of claim 1, wherein the first and second portions of the spectrum are at centered at wavelengths of approximately 563-566 nm and approximately 517-518 nm, respectively.

4. The method of claim 3, wherein the third portion of the spectrum is centered at a wavelength of approximately 484 nm.

5. The method of claim 1, wherein the third portion of the spectrum is centered at a wavelength of approximately 484 nm.

6. The method of claim 1, wherein the performance of steps a-e result in a first corrected bilirubin concentration, further comprising the steps of:

f) repeating steps a-e to calculate a second corrected bilirubin concentration; and

g) calculating an average corrected bilirubin concentration based on the first and second corrected bilirubin concentrations.

7. The method of claim 6, wherein different portions of the patient'"'"'s skin are illuminated each time steps a-e are performed.

8. The method of claim 7, wherein the different portions of the patient'"'"'s skin are located on different portions of the patient'"'"'s body.

9. The method of claim 1, wherein the performance of steps a-e result in a first corrected bilirubin concentration, further comprising the steps of:

f) repeating steps a-e at least twice to calculate at least second and third corrected bilirubin concentrations;

g) calculating an average corrected bilirubin concentration and a standard deviation using at least the first, second and third corrected bilirubin concentrations;

h) comparing the calculated standard deviation to a predetermined maximum standard deviation; and

i) repeating steps a-g if the calculated standard deviation exceeds the predetermined maximum standard deviation.

10. A system for determining a bilirubin concentration in a patient, comprising:

means for illuminating a portion of the patient'"'"'s skin with light;

means for detecting a frequency spectrum of light scattered from the skin;

means for determining, from first and second portions of the spectrum, a first parameter indicative of a blood content of the skin and a second parameter indicative of a melanin content of the skin;

means for determining, from a third portion of the spectrum, a third parameter indicative of an uncorrected bilirubin concentration; and

means for calculating a corrected bilirubin concentration based on at least one calibration factor corresponding to at least one of the first, second, and third parameters and values consisting essentially of the first, second and third parameters.

11. The system of claim 10, further comprising:

means for performing a calibration measurement on a calibration target and for storing resulting calibration data, wherein the at least one corresponding calibration factor used by the means for calculating a corrected bilirubin concentration is based on the calibration data.

12. The system of claim 10, further comprising:

means for calculating an average corrected bilirubin concentration and a standard deviation using at least three calculated corrected bilirubin concentrations; and

means for comparing the calculated standard deviation to a predetermined maximum standard deviation.

13. The system of claim 10, further comprising means for holding a removable calibration target that can be used to calibrate the system prior to determining the bilirubin concentration of a mammal.

14. The system of claim 13, further comprising a removable calibration target mounted on the calibration target holding means.

15. The system of claim 14, wherein the removable calibration target comprises a structure that remains attached to the calibration target holding means after a portion of the removable calibration target is removed to allow a measurement to be made.

16. A system for measuring a bilirubin concentration of a patient by directing radiation onto a portion of a skin of the patient and analyzing scattered or reflected radiation returning from the skin, comprising:

a radiation analyzing device for analyzing radiation scattered or reflected from the patient'"'"'s skin and for outputting radiation data;

a radiation source;

at least one radiation transmitting conduit for directing radiation from the radiation source to a portion of the patient'"'"'s skin;

at least one radiation receiving conduit for directing radiation scattered from the patient'"'"'s skin to the radiation analyzing device; and

means for calculating a bilirubin concentration of the patient based on calibrated measurements of the reflected or scattered radiation at first and second wavelength bands indicative of a blood content of the patient'"'"'s skin, and of a melanin content of the patient'"'"'s skin, respectively, and on a calibrated measurement of the reflected or scattered radiation at a third wavelength band indicative of the patient'"'"'s bilirubin concentration.

17. The system of claim 16, wherein the at least one radiation transmitting conduit directs radiation at the patient'"'"'s skin at acute angle relative to an axis perpendicular to the skin surface.

18. The system of claim 17, wherein the angle is approximately twelve degrees.

19. The system of claim 17, wherein the angle is large enough to reduce radiation backscattering.

20. The system of claim 16, wherein the at least one radiation transmitting conduit comprises a plurality of radiation transmitting conduits, and wherein the at least one radiation receiving conduit is surrounded by the plurality of radiation transmitting conduits.

21. The system of claim 20, wherein the plurality of radiation transmitting conduits are arranged in first and second annular rings, the first annular ring surrounding the at least one radiation receiving conduit, and the second annular ring surrounding the at least one radiation receiving conduit and the first annular ring.

22. The system of claim 16, wherein a numerical aperture of the at least one radiation transmitting conduit is matched to the radiation source, and wherein a numerical aperture of the at least one radiation receiving conduit is matched to the radiation analyzing device.

23. The system of claim 22, wherein the numerical aperture of the at least one radiation transmitting conduit is different from the numerical aperture of the at least one radiation receiving conduit.

24. The system of claim 16, further comprising a window located between the radiation transmitting and receiving conduits and an exterior measuring end of the system, wherein the window comprises a soft polymer that acts as an index matching agent between the radiation transmitting and receiving conduits and the patient'"'"'s skin.

25. The system of claim 16, wherein a length of the at least one radiation receiving conduit is sufficiently long such that mode scrambling occurs.

26. The system of claim 16, further comprising a proximity sensing device for sensing a proximity of a distal end of the radiation transmitting and receiving conduits to the patient'"'"'s skin.

27. The system of claim 26, wherein the system only measures the condition of the patient when the proximity sensing device indicates that the radiation transmitting and receiving conduits are within a predetermined proximity to the patient'"'"'s skin.

28. The system of claim 26, wherein the proximity sensing device comprises a spring loaded annulus that surrounds the radiation transmitting and receiving conduits.

29. The system of claim 16, further comprising a transmitter for transmitting data regarding the calculated condition of the patient to a remote recording device.

30. The system of claim 29, wherein the transmitter comprises an infrared transmitter.

31. The system of claim 16, wherein the radiation analyzing device comprises a spectrometer.

32. The system of claim 16, wherein the radiation analyzing device comprises a diffraction grating and a plurality of detectors, wherein the diffraction grating focuses radiation having predetermined wavelengths on respective ones of the plurality of detectors.

33. The system of claim 16, wherein the radiation analyzing device comprises at least one radiation detector and a plurality of radiation filters, each of the plurality of radiation filters allowing only a narrow wavelength band of radiation to reach the at least one radiation detector.

34. The system of claim 16, wherein the radiation analyzing device comprises a radiation detector and a linear variable filter for allowing selected wavelengths of radiation to reach the radiation detector.

35. A method for determining a bilirubin concentration of a patient, comprising the steps of:

a) illuminating a portion of a skin of the patient with light;

b) detecting a frequency spectrum of light scattered from the skin;

c) determining, from first and second portions of the spectrum, a first parameter indicative of a blood content of the skin and a second parameter indicative of a melanin content of the skin;

d) determining, from a third portion of the spectrum, a third parameter indicative of an uncorrected bilirubin concentration; and

e) correcting the first, second and third parameters based on a calibration factor, and calculating a corrected bilirubin concentration based on the corrected first, second and third parameters.

36. The method of claim 35, further comprising the step of performing a calibration measurement on a calibration target and storing resulting calibration data prior to illuminating the patient'"'"'s skin with light, wherein the calibration factor used to correct the first, second and third parameters is based on the calibration data.

37. The method of claim 35, wherein the first and second portions of the spectrum are at centered at wavelengths of approximately 563-566 nm and approximately 517-518 nm, respectively.

38. The method of claim 37, wherein the third portion of the spectrum is centered at a wavelength of approximately 484 nm.

39. The method of claim 35, wherein the performance of steps a-e result in a first corrected bilirubin concentration, further comprising the steps of:

f) repeating steps a-e to calculate a second corrected bilirubin concentration; and

g) calculating an average corrected bilirubin concentration based on the first and second corrected bilirubin concentrations.

40. The method of claim 35, wherein the performance of steps a-e result in a first corrected bilirubin concentration, further comprising the steps of:

f) repeating steps a-e at least twice to calculate at least second and third corrected bilirubin concentrations;

g) calculating an average corrected bilirubin concentration and a standard deviation using at least the first, second and third corrected bilirubin concentrations;

h) comparing the calculated standard deviation to a predetermined maximum standard deviation; and

i) repeating steps a-g if the calculated standard deviation exceeds the predetermined maximum standard deviation.

41. A system for determining a bilirubin concentration in a patient, comprising:

means for illuminating a portion of the patient'"'"'s skin with light;

means for detecting a frequency spectrum of light scattered from the skin;

means for determining, from first and second portions of the spectrum, a first parameter indicative of a blood content of the skin and a second parameter indicative of a melanin content of the skin;

means for determining, from a third portion of the spectrum, a third parameter indicative of an uncorrected bilirubin concentration; and

means for calculating a corrected bilirubin concentration based on corrected parameters corresponding to the first, second and third parameters.

42. The system of claim 41, further comprising:

means for performing a calibration measurement on a calibration target and for storing resulting calibration data, wherein the corrected parameters are based on the calibration data.

43. The system of claim 41, further comprising:

means for calculating an average corrected bilirubin concentration and a standard deviation using at least three calculated corrected bilirubin concentrations; and

means for comparing the calculated standard deviation to a predetermined maximum standard deviation.

44. The system of claim 41, further comprising means for holding a removable calibration target that can be used to calibrate the system prior to determining the bilirubin concentration of a mammal.

45. The system of claim 44, wherein a removable calibration target mounted on the calibration target holding means comprises a structure that remains attached to the calibration target holding means after at least a portion of the removable calibration target is removed to allow a measurement to be made.