Non-invasive optical measurement of blood analyte

• US 10,548,520 B2
• Filed: 03/31/2016
• Issued: 02/04/2020
• Est. Priority Date: 04/01/2015
• Status: Active Grant

• Current Assignee: Santec Holdings Corp.
• Original Assignee: Santec Incorporated
• Inventors: Chong, Changho
• Primary Examiner(s): Winakur, Eric F
• Application Number:
  US15/086,520
• Publication Number:
  US 20160287154A1
• Time in Patent Office: 1,405 Days
• Field of Search: 600318
• CPC Class Codes: A61B 3/102 for optical coherence tomography [OCT]
• CPC Class Codes: A61B 3/1233 for measuring blood flow, e.g. at the retina
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/1075 for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer A61B8/0858 takes precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14555 specially adapted for the eye fundus
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6821 Eye

Abstract

Methods and devices for accurate noninvasive measurement of blood analyte concentrations are disclosed. In an example process, optical properties of a blood vessel proximate to the surface of an exposed body part, for example, the sclera or the backside of the eyelid, is measured. Analyte concentrations are determined based on the measured optical properties.

Claims

1. A method comprising:

receiving, by a processing system from a light detector, information associated with first optical signals detected by the light detector, wherein the first optical signals are detected from a first area illuminated by a light source, wherein the first area includes a blood vessel, and wherein the blood vessel is proximate to a surface of an exposed body part; and

determining, by the processing system, a concentration of a blood analyte based on the received information associated with the first optical signals, wherein determining the concentration of the blood analyte comprises;

determining a first light absorption profile from the information associated with the first optical signals detected by the light detector from an area including the blood vessel;

detecting a size of the blood vessel;

comparing the first light absorption profile to a plurality of pre-determined light absorption profiles having known blood analyte concentrations; and

calibrating a determined relative analyte concentration based on the size of the blood vessel.

2. The method of claim 1, wherein there is no skin layer between the blood vessel and the surface of the exposed body part at the first area.

3. The method of claim 1, wherein the first area is on an eye.

4. The method of claim 1, wherein the exposed body part is a sclera of an eye.

5. The method of claim 1, wherein the exposed body part is a backside of an eye lid.

6. The method of claim 1, wherein the blood analyte is one of glucose or oxidized hemoglobin.

7. The method of claim 1, wherein determining the concentration of the blood analyte further comprises:

determining, from the information associated with the first optical signals detected by the light detector, a second light absorption profile for an area not having the blood vessel;

generating a differential light absorption profile based on differences between the first light absorption profile and the second light absorption profile; and

determining the concentration of the blood analyte based on the differential light absorption profile.

8. The method of claim 1, further comprising:

receiving, by the processing system, from the light detector, information associated with second optical signals detected by the light detector, wherein the second optical signals are detected from a second area illuminated by the light source, wherein the second area is adjacent to the first area, and wherein the second area does not include a blood vessel; and

calibrating, by the processing system, the concentration of the blood analyte based on the received information associated with the second optical signals.

9. The method of claim 1, further comprising:

receiving, by the processing system, from a temperature monitor, information associated with a temperature of the first area detected by the temperature monitor; and

calibrating, by the processing system, the concentration of the blood analyte based on the information associated with the temperature.

10. The method of claim 1, wherein the information associated with the first optical signals comprises polarization rotation, Raman spectrum, optical coherence tomography, near infrared spectrum, or mid-infrared spectrum.

11. The method of claim 1, wherein the blood vessel at the first area is located less than 0.5 millimeter deep under the surface of the exposed body part.

12. A non-invasive analyte detection device comprising:

a light source configured to illuminate a first area, wherein the first area includes a blood vessel, and wherein the blood vessel is proximate to a surface of an exposed body part;

a light detector configured to detect first optical signals from the first area; and

a processor configured to;

receive information associated with the first optical signals;

determine a first light absorption profile from the received information associated with the first optical signals

determine a size of the blood vessel; and

determine a concentration of a blood analyte based on the first light absorption profile and the size of the blood vessel.

13. The device of claim 12, wherein the exposed body part is a sclera of an eye.

14. The device of claim 12, wherein the exposed body part is a backside of an eye lid.

15. The device of claim 12, wherein the blood analyte is glucose.

16. The device of claim 12, wherein the blood analyte is oxidized hemoglobin.

17. The device of claim 12, wherein:

the light source is further configured to illuminate a second area, wherein the second area is adjacent to the first area, and wherein the second area does not include a blood vessel;

the light detector is further configured to detect second optical signals from the second area; and

the processor is further configured to;

receive information associated with the second optical signals;

create a second light absorption profile based on the received second optical signals;

calibrate the concentration of the blood analyte based on the second light absorption profile.

18. The device of claim 12, further comprising a temperature monitor configured to detect a temperature of the first area, wherein the processor is further configured to receive information associated with the detected temperature from the temperature monitor and to calibrate the concentration of the blood analyte based on the information associated with the temperature.

19. The device of claim 12, wherein the information associated with the first optical signals comprises polarization rotation, Raman spectrum, optical coherence tomography, near infrared spectrum, or mid-infrared spectrum.