Method and apparatus for non-invasively measuring the amount of glucose in blood

• US 6,067,463 A
• Filed: 01/05/1999
• Issued: 05/23/2000
• Est. Priority Date: 01/05/1999
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Pezzaniti, Joseph Larry, Stalder, Arnold F., Szuts, Ete Z., Khalil, Omar S., Jeng, Tzyy-Wen, Hanna, Charles F., Oosta, Gary M., Yeh, Shu-Jen, Lindberg, John M.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/225,430
• Time in Patent Office: 504 Days
• Field of Search: 600/310, 600/316, 600/317, 600/322, 600/323, 600/326, 600/336, 600/473, 600/476
• US Class Current: 600/336
• 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 and apparatus for measuring the concentration of an analyte of interest, e.g. glucose, in blood non-invasively, i.e., without penetrating the skin or obtaining a biological sample from the body of a patient. The method and apparatus uses a plurality of measurement channels with appropriate wavelengths of interest to control variations of signal and to separate the contribution of the analyte of interest from those of interfering compounds. The method and apparatus of this invention can also be adapted to allow a portion of a body part to be engorged with blood to bring about greater accuracy in optical measurements. In the method of this invention, at least two similar, but not identical, measurements are made concurrently. For example, at least two measurements can be made with similar, but not identical, wavelengths of electromagnetic radiation. The two wavelengths should not be overlapping to allow maximum non-identity. By making measurements concurrently, each measurement channel in the system experiences variations as they occur substantially simultaneously in all channels. By selecting one of the channels as a reference channel and by normalizing the optical measurements of the other channels to this reference channel, the variations common to all channels are eliminated. Removing these common variations from the optical measurements by normalization, such as by calculating ratios of the measurement of each of the measuring channels to that of the reference channel, will allow the actual changes of the signal for a specific analyte of interest to be measured.

Claims

1. An apparatus for determining the concentration of an analyte of interest within the body of a mammal comprising;

(a) at least one source of light, said at least one source of light capable of generating electromagnetic radiation at a plurality of wavelengths;

(b) means for transmitting said radiation into a body part, said transmitting means comprising at least one measurement channel and at least one reference channel;

(c) means for concurrently measuring radiation that has emerged from said body part;

(d) means for normalizing the measurement of radiation from said at least one measurement channel to said at least one reference channel so that noise common to said at least one measurement channel and said at least one reference channel is removed; and

(e) means for processing data to convert said normalized measurement to the concentration of said analyte.

2. The apparatus of claim 1, wherein said at least one source of light is capable of providing light having wavelengths ranging from about 750 nm to about 2500 nm.

3. The apparatus of claim 1, wherein said analyte of interest is selected from the group consisting of glucose, urea, creatinine, ketone, bilirubin, hemoglobin, urobilinogen, and protein.

4. The apparatus of claim 1, wherein said at least one measurement channel comprises at least two measurement channels.

5. The apparatus of claim 1, wherein said at least one measurement channel comprises from two channels to seven channels.

6. The apparatus of claim 1, said means for transmitting said radiation further comprising at least one rotating filter wheel.

7. The apparatus of claim 1, said means for transmitting said radiation further comprising at least one beam splitter.

8. The apparatus of claim 1, said means for concurrently measuring radiation further comprising at least one detector.

9. The apparatus of claim 1, further comprising a means for causing blood to become engorged in an area where said light is transmitted.

10. The apparatus of claim 1, further comprising a means for calibrating said apparatus with known reference values of said analyte of interest.

11. A method for determining the concentration of an analyte of interest within the body of a mammal comprising;

(a) generating electromagnetic radiation at a plurality of wavelengths, said wavelengths being selected so that at least one of said wavelength is used for measurement of said analyte and at least one of said wavelengths is used for reference, said wavelengths not overlapping;

(b) transmitting said electromagnetic radiation into a body part;

(c) concurrently measuring electromagnetic radiation that has emerged from said body part;

(d) normalizing the radiation measured at the wavelength used for measurement to the radiation used for reference to remove noise that is common to both said measurement radiation and said reference radiation, thereby generating a noise reduced measurement;

(e) converting said noise reduced measurement to the concentration of said analyte of interest.

12. The method of claim 11, wherein said electromagnetic radiation has wavelengths ranging from about 750 nm to about 2500 nm.

13. The method of claim 11, wherein said analyte of interest is selected from the group consisting of glucose, urea, creatinine, ketone, bilirubin, hemoglobin, urobilinogen, and protein.

14. The method of claim 11, wherein said step of concurrently measuring is verified by the criteria that the peak value of the cross correlation function of a segment of reference measurement to a measurement reference is greater than 0.5, the size of segment being equivalent to data points covered in a heartbeat pulse.

15. The method of claim 11, wherein said step of concurrently measuring is verified by the criteria that the peak value of the cross correlation function of a segment of reference measurement to a measurement reference is at least 0.90, the size of segment being equivalent to data points covered in a heartbeat pulse.

16. The method of claim 11, wherein said normalizing step involves determining the ratio of said at least one measurement reading to said at least one reference reading.

17. The method of claim 11, further including the step of increasing the amount of blood in the area where radiation is transmitted.

18. The method of claim 17, wherein said step of increasing the amount of blood is carried out by applying heat or vacuum to the surface of skin where radiation is transmitted.

19. The methods of claim 11, wherein the data of said measurement and said reference have been preprocessed by calculating slope of the heartbeat before said normalizing step.

20. The method of claim 11, further including the step of using a multivariate analysis method to relate the noise reduced signals to the known value of the analyte of interest.

21. The method of claim 20, wherein said multivariate analysis method is selected from the group consisting of classical least squares, partial least squares, principle component analysis, and neural networks.