Methods for noninvasively measuring analyte levels in a subject

• US 8,548,549 B2
• Filed: 09/09/2011
• Issued: 10/01/2013
• Est. Priority Date: 08/11/2004
• Status: Active Grant

• Current Assignee: Masimo Corporation
• Original Assignee: GLT Acquisition Corporation
• Inventors: Schurman, Matthew J., Shakespeare, Walter J., Bennett, William Henry
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (J J)
• Application Number:
  US13/229,410
• Publication Number:
  US 20110319731A1
• Time in Patent Office: 753 Days
• Field of Search: 600/310, 600/320, 600/322, 600/323, 600/326, 600/328, 600/340, 600/344, 600/473, 600/476
• US Class Current: 600/328
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• 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

Abstract

A method for noninvasively measuring analyte levels includes using a non-imaging OCT-based system to scan a two-dimensional area of biological tissue and gather data continuously during the scanning. Structures within the tissue where measured-analyte-induced changes to the OCT data dominate over changes induced by other analytes are identified by focusing on highly localized regions of the data curve produced from the OCT scan which correspond to discontinuities in the OCT data curve. The data from these localized regions then can be related to measured analyte levels.

Claims

1. A physiological monitoring system for determining a hemoglobin level using an optical sensor, the system comprising:

a non-invasive reflective optical sensor configured to irradiate biological tissue using a beam of light; and

a physiological monitor comprising at least one processor, the physiological monitor configured to;

obtain scattering measurements of light from the beam reflected by the biological tissue using Optical Coherence Tomography;

identify portions of the measurements of the light corresponding to measurements taken within one or more blood vessels within the biological tissue; and

estimate the hemoglobin level based at least partly on the measurements taken within the one or more blood vessels.

2. The system of claim 1, wherein the beam comprises at least two different wavelengths having measurably different scattering properties for hemoglobin-containing tissue.

3. The system of claim 2, wherein the physiological monitor is configured to estimate the hemoglobin level by identifying hemoglobin-containing tissue based at least partly on the different scattering properties of the at least two different wavelengths of the beam.

4. The system of claim 1, wherein the physiological monitor is configured to identify the portions of the measurements by:

generating a first scattering profile;

identifying a localized region in the first scattering profile where measurement changes due to blood hemoglobin predominate; and

selecting portions of the measurements of the light corresponding to the identified localized region.

5. The system of claim 4, wherein the physiological monitor is further configured to:

generate a second scattering profile; and

compare the second scattering profile with the first scattering profile to identify a region where measurement changes due to blood hemoglobin predominate.

6. The system of claim 1, wherein the beam comprises at least one of infrared and near infrared light.

7. The system of claim 1, wherein the non-invasive reflective optical sensor is configured to generate a reference beam that is adjusted to constructively interfere with the light reflected by the biological tissue.

8. The system of claim 1, wherein the measurements of light include light reflected from hemoglobin in the biological tissue.

9. A physiological monitoring system for determining a hemoglobin level using an optical sensor, the system comprising:

a physiological monitor comprising at least one processor, the physiological monitor configured to;

obtain measurements of reflected light detected by a non-invasive reflective optical sensor from a beam of light generated by the reflective sensor and reflected from biological tissue, the beam of light comprising two or more wavelengths selected to differentiate hemoglobin from another biological constituent based on scattering properties of the beam;

generate light scatter measurements based at least partly on the measurements of the reflected light from the beam of light;

process the light scatter measurements to determine the hemoglobin level of the biological tissue based at least partly on identifying hemoglobin from the light scatter measurements.

10. The system of claim 9, wherein the physiological monitor is configured to process the light scatter measurements by identifying the hemoglobin based at least partly on the scattering properties of the beam.

11. The system of claim 9, wherein the non-invasive reflective optical sensor is configured to generate a reference beam that is adjusted to constructively interfere with the reflected light from the illuminated biological tissue.

12. The system of claim 9, wherein the measurements of reflected light include light reflected from hemoglobin in the biological tissue.

13. The system of claim 9, wherein the two or more wavelengths each have different scattering properties for hemoglobin-containing tissues from the other.

14. The system of claim 13, wherein the at least two wavelengths comprise wavelengths at about 1310 nm, and either about 1450 nm or about 820-960 nm.

15. The system of claim 13, wherein at least one of the two or more wavelengths of light is infrared or near infrared light.

16. The system of claim 13, wherein differences in the scattering properties produced by the at least two wavelengths indicates the presence of hemoglobin.

17. A method of measuring hemoglobin concentration within biological tissue, the method comprising:

generating a beam of light, the beam comprising two or more wavelengths selected to differentiate hemoglobin from another biological constituent based on scattering properties of the beam; and

illuminating biological tissue with the beam;

generating light scatter measurements based at least partly on light from the beam reflected by the illuminated biological tissue; and

processing the light scatter measurements to determine a hemoglobin level of the biological tissue based at least partly on identifying hemoglobin based on the scattering properties of the beam.

18. The method of claim 17, further comprising generating a reference beam and interfering said reference beam with the light from the beam to generate light scatter measurements.

19. The method of claim 17, wherein the two or more wavelengths each have different scattering properties for hemoglobin-containing tissues from the other.

20. The method of claim 19, wherein the at least two wavelengths comprise wavelengths at about 1310 nm, and either about 1450 nm or about 820-960 nm.

21. The method of claim 19, wherein at least one of the two wavelengths of light is infrared or near infrared light.

22. The method of claim 19, wherein differences in the scattering properties produced by the at least two wavelengths indicates the presence of hemoglobin.

23. The method of claim 19, wherein the at least two wavelengths are selected to accentuate contrast between hemoglobin and one or more other biological constituents.

24. The method of claim 17, wherein the beam comprises at least three wavelengths, each having different scattering properties for hemoglobin-containing tissues from the other.

25. The method of claim 17, wherein the hemoglobin level is estimated based at least partly on identifying hemoglobin using light scatter measurements corresponding to one or more blood vessels.

26. The method of claim 23, wherein the one or more other biological constituents are located around the hemoglobin.

27. The method of claim 17, wherein the light from the beam reflected by the illuminated biological tissue includes light reflected from hemoglobin in the illuminated biological tissue.