Non-invasive blood analyte measuring system and method utilizing optical absorption

• US 6,898,451 B2
• Filed: 03/21/2002
• Issued: 05/24/2005
• Est. Priority Date: 03/21/2001
• Status: Expired due to Fees

• Current Assignee: Minformed LLC
• Original Assignee: Minformed LLC
• Inventors: Wuori, Edward R.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US10/104,782
• Publication Number:
  US 20030050541A1
• Time in Patent Office: 1,160 Days
• Field of Search: 600309-310, 600322-326, 600/316, 600/476, 600/473
• US Class Current: 600/322
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• 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 device and method for measuring the concentration of analytes in the blood of a portion of tissue. The device includes a sensor module, a monitor, and a processor (separate from or integral with the sensor module). The sensor module includes a radiation source for emitting radiation to the tissue; a collimator and narrow band filter for processing the radiation after it has transmitted through or been reflected by the tissue; and one or more sensors for sensing the transmitted or reflected radiation. The one or more sensors send a signal to the processor which algorithmically converts the radiation using linear regression or orthogonal functions to determine the concentration of one or more blood analytes. The device self-calibrates to eliminate error caused by variables such as skin character. The sensor module is integrated to reduce size and weight such that it is inobtrusive, and the monitor is compact for transport

Claims

1. A method of non-invasively measuring the concentration of one or more blood analytes in a portion of tissue of a human or animal comprising the steps of:

positioning the portion of tissue near a light source and one or more sensors such that infrared radiation transmitted by the light source is reflected from or transmitted through the portion of tissue and onto the one or more sensors;

exposing the portion of tissue to infrared radiation from the light source;

detecting the infrared radiation transmitted or reflected from the portion of tissue with the one or more sensors;

generating spectral data from the one or more sensors in response to receiving the infrared radiation and communicating the spectral data to a processor;

determining the concentration of one or more blood analytes by orthogonal analysis using self calibration of the spectral data in which the ratio of blood analyte to a blood reference material is used; and

displaying the concentration of the one or more blood analytes.

2. The method of claim 1, wherein step of determining the concentration of one or more blood analytes by orthogonal analysis further includes using weighting functions.

3. The method of claim 2, further including the step of filtering the radiation from the tissue into a plurality of wavelengths before it is detected by the one or more sensors.

4. The method of claim 2, wherein the portion of tissue is an earlobe.

5. The method of claim 2, wherein the blood analyte is lactic acid.

6. The method of claim 2, wherein the blood reference material is selected from the group consisting of water and hemoglobin.

7. The method of claim 2, further including the step of separating the one or more blood analytes by using a ratio of pulsatile hemoglobin to total hemoglobin.

8. The method of claim 2 wherein the concentration of the one or more blood analytes is determined in less than 5 seconds.

9. The method of claim 2, wherein the steps of:

exposing the tissue to infrared radiation,

detecting the infrared radiation,

generating spectral data and communicating it to a processor,

determining the concentration of one or more blood analytes by orthogonal analysis using weighting functions and self calibration of the spectral data in which the ratio of blood analyte to a blood reference material is used; and

displaying the concentration of the one or more blood analytes,

are rapidly repeated to provide continuous information on blood analyte concentrations.

10. The method of claim 9, wherein the human or animal remains ambulatory during the measurement of blood analyte concentrations.

11. A method of detecting injury or fatigue in humans or animals including the steps of:

positioning a portion of tissue near a light source and one or more sensors such that infrared radiation transmitted by the light source is reflected from or transmitted through the portion of tissue and onto the one or more sensors;

exposing the portion of tissue to infrared radiation from the light source;

detecting the infrared radiation transmitted or reflected from the portion of tissue with the one or more sensors;

generating spectral data from the one or more sensors in response to receiving the infrared radiation and communicating the spectral data to a processor;

determining the concentration of lactic acid by orthogonal analysis using weighting functions and self calibration of the spectral data in which the ratio of lactic acid to a blood reference material is used; and

displaying the concentration of the lactic acid.

12. The method of claim 11, wherein the steps of:

exposing the tissue to infrared radiation,

detecting the infrared radiation,

generating spectral data and communicating it to a processor,

determining the concentration of lactic acid by orthogonal analysis using weighting functions and self calibration of the spectral data in which the ratio of lactic acid to a blood reference material is used; and

displaying the concentration of lactic acid,

are rapidly repeated to provide continuous information on lactic acid concentration.

13. The method of claim 12, further including the step of issuing a warning signal when lactic acid levels rise above a predetermined level.

14. A mobile apparatus for the non-invasive measurement of the concentration of one or more blood analytes in the blood of a portion of tissue comprising:

a light source for generating a spectrum of infrared radiation and transmitting the spectrum of radiation to the portion of tissue;

one or more sensors for detecting radiation from the portion of tissue over a broad spectrum and generating an output regarding the detected radiation;

a mounting device for positioning the light source and the one or more sensors approximately adjacent to the portion of tissue;

a processor for receiving the output from the sensors, the processor being configured for performing orthogonal analysis using weighting functions to determine the concentration of one or more blood analytes in the blood of the portion of tissue using self calibration in which the ratio of blood analyte to a blood reference material is used; and

a display for displaying the concentration of the one or more blood analytes.

15. The mobile apparatus of claim 14, wherein the one or more sensors are configured for detecting infrared radiation reflected from the portion of tissue.

16. The mobile apparatus of claim 14, wherein the one or more sensors are configured for detecting infrared radiation transmitted through the portion of tissue.

17. The mobile apparatus of claim 14, further including a source optics device for focusing the infrared radiation from the light source onto a measurement point on the portion of tissue.

18. The mobile apparatus of claim 17, further including a collimator for focusing infrared radiation onto the one or more sensors after it has passed through or reflected from the portion of tissue.

19. The mobile apparatus of claim 18, wherein the mobile apparatus comprises a pocket monitor module and a sensor module capable of communication with the pocket monitor module.

20. The mobile apparatus of claim 19, wherein the sensor module comprises the light source, the one or more sensors, the source optics device, the collimator, and the mounting device.

21. The mobile apparatus of claim 19, wherein the sensor module comprises two microprocessor chips and wherein the light source is mounted to one microprocessor chip and the one or more sensors are mounted on the other microprocessor chip.

22. The mobile apparatus of claim 20, wherein the sensor module comprises a radio frequency transmitter and the pocket monitor module comprises a radio frequency receiver.

23. The mobile apparatus of claim 22, wherein the sensor module further comprises the mounting apparatus for positioning the light source and the one or more sensors approximately adjacent to the portion of tissue, and wherein the portion of tissue comprises an ear lobe.

24. The mobile apparatus of claim 14, wherein the one or more sensors are capable of detecting near infrared regions of wavelengths of about 700 nm to about 2500 nm.

25. The mobile apparatus of claim 14, wherein the mobile apparatus is adapted to detect blood analytes with an error margin of 10% or less.

26. The mobile apparatus of claim 14, wherein the sensors comprise direct silicon sensors sensitive to radiation of a wavelength range from about 0.4 to 1.1 microns and infrared sensors sensitive to radiation of a wavelength range from 1 to 10 microns.

27. The mobile apparatus of claim 26, wherein the infrared sensors are thermocouples comprising two metal layers and a gold black layer.

28. The mobile apparatus of claim 27, wherein one of the two metal layers comprises a nickel-chromium alloy while the other of the two metal layers comprises a nickel-copper alloy.

29. The mobile apparatus of claim 14, further including a filter for separating radiation from the portion of tissue into various wavelengths, the filter being positioned such that the infrared radiation from the tissue passes through the filter prior to detection by the one or more sensors.

30. An ambulatory system for the rapid and continuous, non-invasive measurement of the concentration of one or more blood analytes comprising a sensor module and a pocket monitor module, wherein the sensor module comprises:

a light source for generating and transmitting infrared radiation to an ear lobe;

a focusing device for focusing the infrared radiation from the light source onto a measurement point on the ear lobe;

a filter for separating the infrared radiation into separate wavelengths;

one or more sensors for detecting infrared radiation transmitted or reflected from the measurement point and generating spectral data corresponding to the detected infrared radiation received;

a means for mounting the light source, the focusing device, the filter, and the one or more sensors on the ear lobe to facilitate the transmission of infrared radiation through the earlobe and to the one or more sensors;

a processor for receiving spectral data from the sensors, the processor being configured for performing orthogonal analysis to determine blood analyte concentration data using self calibration in which the ratio of one or more blood analytes to a blood reference material is used; and

a radio frequency transmitter for transmitting the blood analyte concentration data over a short distance; and

the pocket monitor module comprises;

a radio frequency receiver for obtaining blood analyte concentration data from the sensor module; and

a monitor for displaying the blood analyte concentration data.

31. The ambulatory system of claim 30, wherein the sensor module further includes a collimator for refocusing the infrared radiation after scattering in the ear lobe.