Non-invasive analyte measurement device having increased signal to noise ratios

• US 20040225206A1
• Filed: 05/09/2003
• Published: 11/11/2004
• Est. Priority Date: 05/09/2003
• Status: Abandoned Application

• Current Assignee: Medoptix Incorporated
• Original Assignee: Medoptix Incorporated
• Inventors: Kouchnir, Mikhail A.
• Application Number:
  US10/434,963
• Publication Number:
  US 20040225206A1
• Time in Patent Office: Days
• US Class Current: 600/316
• 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: G01N 21/3151 using two sources of radiation of different wavelengths G01N21/33 - G01N21/39 take precedence
• CPC Class Codes: G01N 21/35 using infrared light G01N21/39 takes precedence
• CPC Class Codes: G01N 21/552 Attenuated total reflection

Abstract

A non-invasive analyte measurement device having increased signal to noise ratios is disclosed herein. Typically, the glucose measurement device is self-normalizing in that it does not employ an independent reference sample in its operation. The device uses attenuated total reflection (ATR) infrared spectroscopy. The device is used on a fingertip and compares two specific regions of a measured infrared spectrum to determine the blood glucose level of the user. This device is suitable for monitoring glucose levels in the human body and is especially beneficial to users having diabetes mellitus. Moreover, the device utilizes a periodically modulated optical signal and at least one lock-in amplifier to correlate the signals to gain maximum sensitivity and an increased signal-to-noise ratio. The device and procedure can be used for other analyte materials which exhibit unique mid-IR signatures of the type described herein and that are found in appropriate regions of the outer skin.

Claims

1. An analyte level measurement device for measuring an analyte level in a body by contacting a skin surface, comprising:

an infrared source for emitting an IR beam into an ATR plate, the IR beam having components at least in the region of a referencing wavelength and a measuring wavelength;

at least two IR sensors for simultaneously measuring absorbance of at least the referencing wavelength and the measuring wavelength; and

at least one lock-in amplifier in communication with a corresponding IR sensor, the at least one lock-in amplifier being adapted to correlate the infrared source with an output signal from the IR sensors.

2. The device of claim 1 wherein the ATR plate has a measurement surface for contact with the skin surface and for directing the IR beam against the skin surface.

3. The device of claim 1 further comprising a processor for determining the analyte level using a measured absorbance of the skin surface.

4. The device of claim 3 wherein the processor comprises a comparator for comparing the measuring wavelength to the referencing wavelength and providing a signal indicative of blood glucose concentration.

5. The device of claim 1 further comprising a modulator for periodically modulating an intensity of the IR beam and maintaining a fixed relationship with the at least one lock-in amplifier.

6. The device of claim 5 wherein the fixed relationship is a fixed phase relationship.

7. The device of claim 5 wherein the IR beam intensity is modulated in a pattern selected from the group consisting of sinusoidal, saw tooth, and square wave.

8. The device of claim 1 further comprising a memory unit for storing parameters of the measured absorbance.

9. The device of claim 1 further comprising a display for indicating a processed result from the measured absorbance.

10. The device of claim 1 wherein the ATR plate is configured to permit multiple internal reflections therewithin prior to measuring the absorbance.

11. The device of claim 1 wherein the analyte comprises glucose and the referencing wavelength is between about 8.25 μ

m and 8.75 μ

m.

12. The device of claim 1 wherein the analyte comprises glucose and the measuring wavelength is between about 9.50 μ

m and 10.00 μ

m.

13. The device of claim 1 further comprising a beam splitter positioned between the ATR plate and the at least two IR sensors.

14. The device of claim 1 wherein each of the at least two IR sensors is in communication with a corresponding lock-in amplifier.

15. A method for determining an analyte level in a body with an analyte measurement device, comprising:

contacting a skin surface on the body with an ATR plate in the analyte measurement device, the ATR plate having a surface for contact with the skin surface;

irradiating the skin surface with a periodically modulated IR beam having components at least in a region of a referencing wavelength and a measuring wavelength through the ATR plate to produce a reflected IR beam indicative of the analyte level in the body; and

correlating the referencing wavelength and the measuring wavelength components in the reflected IR beam with the periodically modulated IR beam so as to detect the analyte level.

16. The method of claim 15 further comprising maintaining the skin surface against the ATR plate at an adequate pressure.

17. The method of claim 15 further comprising normalizing the analyte measurement device by simultaneously detecting and quantifying the referencing wavelength and the measuring wavelength components in the reflected IR beam prior to contacting the skin surface on the body with the ATR plate.

18. The method of claim 15 where the periodically modulated IR beam is modulated in a pattern selected from the group consisting of sinusoidal, saw tooth, and square wave.

19. The method of claim 15 where correlating the referencing wavelength and the measuring wavelength components comprises correlating the components via at least one lock-in amplifier.

20. The method of claim 15 further comprising storing parameters of the analyte level in a memory unit.

21. The method of claim 15 further comprising displaying the analyte level.

22. The method of claim 15 wherein the referencing wavelength is between about 8.25 μ

m and about 8.75 μ

m.

23. The method of claim 15 wherein the measuring wavelength is between about 9.50 μ

m and about 10.00 μ

m.

24. The method of claim 15 further comprising splitting the reflected beam to form two beams and introducing the two beams each to one of at least two IR sensors.