Zero corrected optical blood analyte detector

• US 7,039,448 B2
• Filed: 04/27/2004
• Issued: 05/02/2006
• Est. Priority Date: 05/02/2003
• Status: Active Grant

• Current Assignee: DIRAmed LLC
• Original Assignee: DIRAmed LLC
• Inventors: Ricca, Steven V., Rihl, John M., Schlegel, Robert P.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): Natarajan, Vivek
• Application Number:
  US10/832,873
• Publication Number:
  US 20040220459A1
• Time in Patent Office: 735 Days
• Field of Search: 600/310, 600/316, 600/322, 600/473
• 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

Abstract

The present invention is directed to method and apparatus for non-invasively measuring the concentration of an unknown blood analyte present in a patient. The method involves determining the concentration of a reference analyte present in the patient. Using the non-invasive optical instrument of the invention, the concentrations of the reference analyte and unknown analyte are measured. If the measured reference analyte concentration and determined reference analyte concentration are substantially the same, then the measured unknown analyte concentration is displayed. If the measured reference analyte concentration and determined reference analyte concentration are not substantially the same, then an adjustment factor is applied to the measured unknown analyte concentration and the unknown analyte concentration is displayed.

Claims

1. A non-invasive method for measuring the concentration of an unknown blood analyte present in a patient, which comprises the steps of:

(a) determining the concentration of a reference analyte present in said patient;

(b) non-invasively, optically measuring the concentrations of said reference analyte and said unknown analyte;

(c) displaying said measured unknown analyte concentration when said measured reference analyte concentration and said determined reference analyte concentration are substantially the same; and

(d) if said measured reference analyte concentration and said determined reference analyte concentration are not substantially the same, applying an adjustment factor to said measured unknown analyte concentration and displaying said unknown analyte concentration.

2. The method of claim 1, wherein said reference analyte comprises cholesterol and said unknown analyte comprises glucose.

3. The method of claim 1, wherein said reference analyte comprises keratin and said unknown analyte comprises glucose.

4. The method of claim 1, wherein said adjustment factor of step (d) comprises a value selected from a look-up table of values based on the concentration difference between said determined reference analyte concentration and said measured reference analyte concentration.

5. The method of claim 1, wherein said step (a) comprises determining the concentration of said reference analyte in said patient by conducting an in vitro blood sample analysis.

6. The method of claim 1, wherein said steps (b), (c), and (d) are performed using an instrument comprising:

(i) an IR source generating an IR output capable of penetrating through target tissue of said patient to produce a tissue IR output correlative with said reference analyte concentration and said unknown analyte concentration,

(ii) an optical detector capable of detecting said tissue IR output,

(iii) a signal treatment system for converting said tissue IR output into said reference analyte concentration and said unknown analyte concentration,

(iv) memory capable of storing said determined reference analyte concentration, said measured reference analyte and unknown analyte concentrations, and said adjustment factor,

(v) a microprocessor programmed to compare said detected reference analyte concentration to said determined reference analyte concentration and transmit said detected unknown analyte concentration to said display when said detected reference analyte concentration and said determined reference analyte concentration are substantially the same, or to apply said adjustment factor to said unknown analyte concentration and transmit said unknown analyte concentration to said display when said detected reference analyte concentration and said determined reference analyte concentration are not substantially the same,

(vi) a display for displaying said unknown analyte concentration, and

(vii) said IR source, said optical detector, said signal treatment system, said memory, said microprocessor, and said display being in communication.

7. The method of claim 6, wherein one or more of said IR source, optical detector, signal treatment system, memory, microprocessor, or display are housed in one or more housings.

8. The method of claim 6, wherein one or more of said signal treatment system, said memory, said microprocessor or said display are located at a site remote from said patient.

9. The method of claim 6, wherein said optical detector comprises said signal treatment system.

10. The method of claim 6, wherein said signal treatment system treats said IR source output by one or more of autozeroing, amplifying, or filtering.

11. An instrument for non-invasively measuring the concentration of an unknown blood analyte in a patient, which comprises:

(a) an IR source generating an IR output capable of penetrating through target tissue of said patient to produce a tissue IR output correlative with said reference analyte concentration and said unknown analyte concentration;

(b) an optical detectors capable of detecting said tissue IR output;

(c) a signal treatment system for converting said tissue IR output into said reference analyte concentration and said unknown analyte concentration;

(d) memory capable of storing said determined reference analyte concentration, said measured reference analyte and unknown analyte concentrations, and said adjustment factor;

(e) a microprocessor programmed to compare said detected reference analyte concentration to said determined reference analyte concentration and transmit said detected unknown analyte concentration to said display when said detected reference analyte concentration and said determined reference analyte concentration are substantially the same, or to apply said adjustment factor to said unknown analyte concentration and transmit said unknown analyte concentration to said display when said detected reference analyte concentration and said determined reference analyte concentration are not substantially the same;

(f) a display for displaying said unknown analyte concentration; and

(g) said IR source, said optical detector, said signal treatment system, said memory, said microprocessor, and said display being in communication.

12. The instrument of claim 11, wherein said optical detector comprises said signal treatment system.

13. The instrument of claim 11, wherein said reference analyte comprises cholesterol and said unknown analyte comprises glucose.

14. The instrument of claim 11, wherein said reference analyte comprises keratin and said unknown analyte comprises glucose.

15. The instrument of claim 11, wherein one or more of said IR source, optical detector, signal treatment system, memory, microprocessor, or display are housed in one or more housings.

16. The instrument of claim 11, wherein one or more of said signal treatment system, said memory, said microprocessor or said display are located at a site remote from said patient.

17. The instrument of claim 11, wherein said signal treatment system treats said IR source output by one or more of autozeroing, amplifying, or filtering.