Robust accurate non-invasive analyte monitor

• US 6,278,889 B1
• Filed: 09/30/1999
• Issued: 08/21/2001
• Est. Priority Date: 08/24/1993
• Status: Expired due to Term

• Current Assignee: National Technology & Engineering Solutions Of Sandia LLC (Honeywell International Inc.)
• Original Assignee: Mark R. Robinson
• Inventors: Robinson, Mark R.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/410,193
• Time in Patent Office: 691 Days
• Field of Search: 600/322, 600/323, 600/310, 356/41
• US Class Current: 600/322
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/046 in a matrix array
• 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 21/359 using near infrared light
• CPC Class Codes: G01N 21/49 within a body or fluid
• CPC Class Codes: G01N 2201/0621 Supply

Abstract

An improved method and apparatus for determining noninvasively and in vivo one or more unknown values of a known characteristic, particularly the concentration of an analyte in human tissue. The method includes: (1) irradiating the tissue with infrared energy (400 nm-2400 nm) having at least several wavelengths in a given range of wavelengths so that there is differential absorption of at least some of the wavelengths by the tissue as a function of the wavelengths and the known characteristic, the differential absorption causeing intensity variations of the wavelengths incident from the tissue; (2) providing a first path through the tissue; (3) optimizing the first path for a first sub-region of the range of wavelengths to maximize the differential absorption by at least some of the wavelengths in the first sub-region; (4) providing a second path through the tissue; and (5) optimizing the second path for a second sub-region of the range, to maximize the differential absorption by at least some of the wavelengths in the second sub-region. In the preferred embodiment a third path through the tissue is provided for, which path is optimized for a third sub-region of the range. With this arrangement, spectral variations which are the result of tissue differences (e.g., melanin and temperature) can be reduced. At least one of the paths represents a partial transmission path through the tissue. This partial transmission path may pass through the nail of a finger once and, preferably, twice. Also included are apparatus for: (1) reducing the arterial pulsations within the tissue; and (2) maximizing the blood content in the tissue.

Claims

1. A method of determining noninvasively an unknown value of a known characteristic, particularly the concentration of at least one analyte in tissue containing multiple spectral interferences, said method including the steps of:

(a) providing at least one source of infrared energy having multiple wavelengths;

(b) using at least one means for introducing said infrared energy into said tissue and at least one means for collecting said infrared energy to provide first and second optical paths of different lengths through said tissue;

(c) measuring with at least one detector the intensities of at least some of said multiple wavelengths which have traversed said tissue through said first and second optical paths; and

(d) calculating said unknown value by using said measured intensities from said first and said second optical paths, said calculating using said measured intensities from both optical paths to compensate for said spectral interferences in said tissue.

2. The method as set forth in claim 1, wherein said spectral interferences include but are not limited to differences in hydration, the amount of blood in said tissue, temperature differences, melanin differences, blood analyte concentration differences and epidermal differences.

3. The method as set forth in claim 1 wherein said wavelengths collected from said first path are different from the wavelengths collected from said second path.

4. In a method of determining noninvasively and in vivo one or more unknown values of a known characteristic, including the steps of irradiating human tissue with at least one source of infrared energy having at least several wavelengths in a given range of wavelengths so that there is differential absorption of at least some of said wavelengths by said tissue as a function of said wavelengths and said characteristic, said differential absorption causing intensity variations of said wavelengths, collecting with at least one detector at least some of said wavelengths that have traversed an average optical path through said tissue, and calculating said one or more unknown values of said known characteristic, the improvement comprising:

positioning said at least one source and at least one detector relative to said tissue to provide at least first and second average optical paths through said tissue, said first path being different in length from said second path, and wherein said calculating uses intensities obtained from said first and second paths to compensate for spectral interferences.

5. The method as set forth in claim 4, wherein said range is between 400 and 2400 nm.

6. The method as set forth in claim 4, wherein at least one of said paths represents a partial transmission path through said tissue.

7. The method as set forth in claim 6, wherein said tissue is a finger and wherein said partial transmission path passes through the nail of said finger at least once.

8. The method as set forth in claim 4, wherein said tissue is irradiated by a plurality of sources of infrared energy.

9. The method as set forth in claim 4, wherein said wavelengths are collected by a plurality of detectors.

10. A method as set forth in claim 4 wherein some of said wavelengths collected from said first path and some of said wavelenght collected from said second path are the same.

11. In a method of determining nonivasively and in vivo one or more unknown values of a known characteristic, including the steps of irradiating human tissue with at least one source of infrared energy having at least several wavelengths in a given range of wavelengths so that there is differential absorption of at least some of said wavelengths by said tissue as a function of said wavelengths and said characteristic, said differential absorption causing intensity variations of said wavelengths, collecting with at least one detector at least some of said wavelengths that have traversed an average optical path through said tissue, and calculating said one or more unknown values of said known characteristic, the improvement comprising:

positioning said at least one source and said at least one detector relative to said tissue to provide at least first, second and third average optical paths through said tissue, said fist, second and third paths being different in length from each other.

12. The method as set forth in claim 11, wherein said first path is for the wavelength sub-region of 2000-2400 nm, said second path is for the wavelength sub-region of 1400-2000 nm, and said third path is for the wavelength sub-region of 400-1400 nm.

13. The method as set forth in claim 12, wherein said first path has a length in the range of 0.5-3 mm, said second path has a length in the range of 3-7 mm, and said third path has a length of approximately 10 mm.

14. In method of determining noninvasively and in vivo one or more unknown values of a known characteristic, including the steps of irradiating human tissue with at least one source of infrared energy having at least several wavelengths in a given range of wavelengths so that there is differential absorption of at least some of said wavelengths by said tissue as a function of said wavelengths and said characteristic, said differential absorption causing intensity variations of said wavelengths, collecting wilh at least one detector at least some of said wavelengths that have traversed an average optical path through said tissue, and calculating said one or more unknown values of said known characteristics, the improvement comprising:

positioning said at least one source and said at least one detector relative to said tissue to provide at least first and second average optical paths through said tissue, said first path being different in length from said second path, one of said paths representing a partial transmission path which passes through the nail of a finger twice.