Method and apparatus for non-invasive monitoring of blood glucose

• US 5,119,819 A
• Filed: 05/02/1990
• Issued: 06/09/1992
• Est. Priority Date: 05/02/1990
• Status: Expired due to Term

• Current Assignee: Miles, Inc. (Bayer AG)
• Original Assignee: Miles, Inc. (Bayer AG)
• Inventors: Watson, Roger M., Noell, J. Oakey, Thomas, Graham H.
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US07/517,699
• Time in Patent Office: 769 Days
• Field of Search: 128/660.02, 128/632, 128/637, 128/597
• US Class Current: 600/438
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: G01N 2291/02466 Biological material, e.g. blood
• CPC Class Codes: G01N 2291/02809 Concentration of a compound, e.g. measured by a surface mass change
• CPC Class Codes: G01N 2291/02881 Temperature
• CPC Class Codes: G01N 29/024 by measuring propagation velocity or propagation time of acoustic waves
• CPC Class Codes: G01N 29/326 compensating for temperature variations

Abstract

A new and improved method and apparatus are provided for non-invasive monitoring of changes in blood glucose concentration in a tissue specimen and particularly in an individual. The method uses acoustic velocity measurements for monitoring the effect of glucose concentration upon the density and adiabatic compressibility of the serum.

In a preferred embodiment, the acoustic velocity measurements are made through the earlobe of a subject by means of an acoustic probe or monitor which includes a transducer for transmitting and receiving ultrasonic energy pulses to and from the blood flowing in the subject'"'"'s earlobe and a reflector for facilitating reflection of the acoustic pulses from the blood. The probe is designed in such a way that when properly affixed to an ear, the transducer is positioned flush against the anterior portion of an earlobe while the reflector is positioned flush against the interior portion of the earlobe. A microthermocouple is provided on the probe for monitoring the internal temperature of the blood being sampled.

An electrical system, essentially comprising a frequency generator, a time intervalometer and an oscilloscope, is linked to the glucose monitoring probe. The electrical system analyzes selected ones of the pulses reflected from the blood sample in order to determine therefrom the acoustic velocity of the blood which, in turn, provides a representation of the blood glucose concentration levels at the time of the acoustic velocity measurements.

Claims

1. A non-invasive monitor of changes in blood glucose concentration in a tissue specimen comprising:

means for transmitting and receiving ultrasonic energy pulses to and from the tissue specimen;

means for reflecting said ultrasonic energy pulses from said tissue specimen, said reflecting means being spaced from said transmitting and receiving means,

means for measuring the travel time between selected ones of said reflected ultrasonic energy pulses to calculate the associated acoustic velocity; and

support means for interconnecting and mounting said transmitting and receiving means for placement of the tissue specimen therebetween, whereby the calculated acoustic velocity is representative of the blood glucose concentration in said tissue specimen.

2. The non-invasive monitor set forth in claim 1 further comprising a thermocouple mounted on said support means for monitoring the internal temperature of said tissue specimen.

3. The non-invasive monitor of claim 2 wherein said monitored temperature is used to adjust said calculated acoustic velocity.

4. Apparatus for non-invasive monitoring of blood glucose concentration levels in a blood sample, comprising:

means disposed in proximity to one of two opposing surfaces of the blood sample for transmitting and receiving a series of acoustic energy pulses to and from said blood sample;

means disposed adjacent the other of said two opposing surfaces of said sample for reflecting said acoustic energy pulses after having passed through said blood sample;

means for measuring the travel time between selected ones of said reflected ultrasonic energy pulses to calculate the associated acoustic velocity, said acoustic velocity being representative of the blood glucose concentration;

support means for interconnecting and mounting said transmitting and receiving means and said reflecting means for placement of said blood sample therebetween; and

means disposed on said support means for monitoring the temperature of said blood sample.

5. The non-invasive blood glucose concentration monitor claimed in claim 4 wherein said monitored temperature is used to adjust said calculated acoustic velocity.

6. A method for non-invasive monitoring of changes in blood glucose concentration in a tissue specimen, comprising the steps of:

generating pulses of acoustic energy;

transmitting said pulses of acoustic energy into the tissue specimen;

sensing the pulses of acoustic energy reflected back from said tissue specimen;

measuring the travel time between selected ones of said reflected acoustic energy pulses; and

using said measurements of travel time to calculate the acoustic velocity in said specimen, whereby said calculated acoustic velocity provides an indication of the blood glucose concentration in said tissue specimen.

7. The method for non-invasive monitoring of blood glucose concentration set forth in claim 6 further comprising the steps of monitoring the internal temperature of said tissue specimen and using the monitored temperature to adjust said calculated acoustic velocity.

8. A method of non-invasive monitoring of qlucose concentration levels in blood or like glucose-containing solution, said method comprising the steps of:

transmitting acoustic energy pulses into said solution;

receiving acoustic energy pulses reflected back from said solution; and

analyzing said reflected pulses to determine the acoustic velocity of said solution, whereby said determined acoustic velocity provides an indication of the glucose concentration level of said solution.

9. The non-invasive glucose monitoring method of claim 8 wherein an acoustic transducer is used for transmitting and receiving said acoustic energy pulses to and from said solution.

10. The non-invasive glucose monitoring method of claim 8 wherein reflective means are provided adjacent said solution to facilitate reflection of said acoustic energy pulses.

11. The non-invasive glucose monitoring method of claim 8 wherein the travel time between selected ones of said reflected pulses is determined and the acoustic velocity of said solution calculated therefrom.

12. The non-invasive monitoring technique of claim 8 further including the steps of monitoring the internal temperature of said solution and using the monitored temperature to adjust said determined acoustic velocity.

13. A method of non-invasive monitoring of glucose concentration levels in blood or other glucose-containing solution by

(i) measuring the acoustic velocity of said solution;

and

(ii) using the measured acoustic velocity as a linear measure of the glucose concentration level in said solution.

14. The non-invasive glucose monitoring method of claim 13 wherein the acoustic velocity is measured by using an acoustic transducer for transmitting and receiving acoustic energy pulses to and from said solution and determining the travel time between selected ones of reflected pulses received from said solution.

15. The non-invasive glucose monitoring method of claim 14 wherein said acoustic transducer is used in conjunction with associated delay means for delaying, by a fixed time period, reflected pulses received by said transducer from said solution.