NONINVASIVE ANALYZER APPARATUS AND METHOD OF USE THEREOF FOR SEPARATING DISTRIBUTED PROBING PHOTONS EMERGING FROM A SAMPLE

• US 20160242682A1
• Filed: 12/10/2015
• Published: 08/25/2016
• Est. Priority Date: 07/16/2012
• Status: Abandoned Application

• Current Assignee: Zyomed Corp.
• Original Assignee: Zyomed Corp.
• Inventors: Gulati, Sandeep, Ruchti, Timothy, Hazen, Kevin H.
• Application Number:
  US14/965,807
• Publication Number:
  US 20160242682A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/1079 using optical or photographic means
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: G01J 3/0218 using optical fibers
• CPC Class Codes: G01J 3/2803 using photoelectric array detector
• CPC Class Codes: G01J 3/36 Investigating two or more bands of a spectrum by separate detectors
• CPC Class Codes: G01J 3/42 Absorption spectrometry; Double beam spectrometry; Flicker spectrometry; Reflection spectrometry beam switching arrangements G01J3/08
• CPC Class Codes: G01N 2021/317 Special constructive features
• CPC Class Codes: G01N 2021/4797 time resolved, e.g. analysis of ballistic photons
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 21/4795 spatially resolved investigating of object in scattering medium in vivo A61B
• CPC Class Codes: G01N 2201/062 LED's

Abstract

A noninvasive analyzer apparatus and method of use thereof is described for spatially separating light having noninvasively probed a tissue volume into groups, which narrows standard deviations of probed tissue pathlength for each of the groups. Reduction in tissue pathlength uncertainty subsequently enhances noninvasive analyte concentration determination accuracy. Control of individual detector distance from an illumination zone in combination with control of area of a detection zone coupled to an individual detector yields intensity control of the various groups. The intensity control is optionally aided using several intensity control elements including: control of detector response shape, hardware gain settings set as function of distance from the illumination zone, varying numerical aperture of light collection optics as a function of position from the illumination zone, multiple illumination-detector linked bundlets, micro-optics, segmented spacers, arcs of detector elements, and/or outlier analysis based on detected intensity as a function of position.

Claims

1. An apparatus for detecting distributed probing light emerging from a subject, comprising:

a noninvasive analyzer, comprising;

a near-infrared light source configured to provide photons during use;

an optical interface to the subject, comprising;

an illumination area; and

a detection area comprising, during use, a surface area of the subject,

wherein, during use, the photons sequentially pass through the illumination area into a portion of the subject and out of the subject through the detection area;

a set of detectors within ten centimeters of the illumination area, said set of detectors comprising;

a first detector optically coupled to a first detection zone of the detection area; and

a second detector optically coupled to a second detection zone of said detection area,

the second detection zone;

(1) at least twenty percent larger than the first detection zone and (2) positioned radially outward from the illumination area relative to the first detection zone.

2. The apparatus of claim 1, said set of detectors further comprising:

a first group of detectors, electrically connected for readout in series, said first group of detectors optically linked to a first set of detection zones at least partially circumferentially encircling the illumination area at a first radial distance;

a second group of detectors, electrically connected for readout in series, said second group of detectors optically linked to a second set of detection zones at least partially circumferentially encircling the illumination area at a second radial distance.

3. The apparatus of claim 2, further comprising:

a segmenting spacer extending perpendicularly from the detection area into said optical interface between;

(1) said first group of detectors and (2) said second group of detectors, said segmenting spacer comprising at least one of;

an air gap;

a mirrored surface; and

a change in refractive index, as measured by Snell'"'"'s Law, sufficient to redirect photons striking the segmented spacer back toward an axis running both perpendicular to the detection area and through a point of exit of the photons from the subject during use.

4. The apparatus of claim 2, the illumination area further comprising:

a first ring illumination area coupled to a first light source; and

a second ring illumination area coupled to a second light source.

5. The apparatus of claim 2, further comprising:

a two-dimensional optical filter array; and

a two-dimensional micro-optic array comprising a first face substantially in proximate contact with said two-dimensional optical filter array, at least one of said two-dimensional optical filter array and said two-dimensional micro-optic array comprising a second face substantially in proximate contact with said set of detectors.

6. The apparatus of claim 2, said set of detectors further comprising:

a first hardware gain linked to said first group of detectors; and

a second hardware gain linked to said second group of detectors, said second hardware gain at least ten percent larger than said first hardware gain.

7. The apparatus of claim 1, said set of detectors further comprising:

at least three detectors optically linked to a corresponding at least three detection zones of the detection area, the at least three detection zones of increasing area as a function of radial distance from the illumination zone.

8. The apparatus of claim 1, further comprising:

a first geometric unit of detectors positioned a first direction from the illumination zone; and

a second geometric unit of detectors positioned a second direction from the illumination zone, said second geometric unit of detectors comprising a common geometry with said first geometric unit of detectors, said second geometric unit of detectors rotated relative to an orientation of said first geometric unit of detectors.

9. The apparatus of claim 8, further comprising:

a set of detector readout elements placed proximate an outer perimeter of a space occupied by a union of the illumination zone, the first geometric unit of detectors, and the second geometric unit of detectors.

10. The apparatus of claim 1, further comprising:

a set of micro-optics aligned with detection elements of said set of detectors, said set of micro-optics comprising a first micro-optic and a second micro-optic,

said first micro-optic, coupled to the first detection zone, comprising a first numerical aperture,

said second micro-optic, coupled to the second detection zone, comprising a second numerical aperture,

said first numerical aperture coupled to the first detection zone, positioned radially inward from the second detection zone, at least ten percent greater than said second numerical aperture.

11. The apparatus of claim 10, said set of micro-optics further comprising:

at least three optics positioned at increasing radial distance from the illumination zone, said at least three optics comprising three numerical apertures that decrease as a function of distance from the illumination zone.

12. The apparatus of claim 1, the illumination area further comprising:

a set of illumination zones, comprising;

a first illumination zone at least partially circumferentially encircled by a first group of detection zones, the first group of detection zones comprising at least two rings of detection zones linked to at least two groups of detectors of said set of detectors; and

a second illumination zone at least partially circumferentially encircled by a second group of detection zones linked to a third group of detectors, the second illumination zone positioned outside of the first group of detection zones.

13. The apparatus of claim 12, wherein a member of said at least two groups of detectors is a member of said third group of detectors.

14. The apparatus of claim 2, wherein said first detector further comprises a first indium gallium arsenide detection element of a first thickness,

wherein said second detector further comprises a second indium gallium arsenide detection element of a second thickness, said second thickness at least ten percent thicker than said first thickness,

wherein a difference between said first thickness and said second thickness alters a wavelength response profile of said first detector relative to said second detector.

20. The method of claim 10, further comprising the steps of:

illuminating a first sub-area of the illumination area at a first time; and

illuminating a second sub-area of the illumination area at a second time, wherein a difference in distance between;

(1) the first-sub area and the first detection zone and (2) the second-sub area and the first detection zone yields detection of differing mean total pathlengths of the photons in the subject using said set of detectors.

15. A method for detecting distributed probing light emerging from a subject, comprising the steps of:

providing a noninvasive analyzer, comprising;

a near-infrared light source;

an optical interface to the subject comprising;

an illumination area and a detection area comprising a surface area of the subject; and

a set of detectors within ten centimeters of the illumination area, said set of detectors comprising;

a first detector optically coupled to a first detection zone of the detection area; and

a second detector optically coupled to a second detection zone of the detection area,

the second detection zone;

(1) at least twenty percent larger than the first detection zone and (2) positioned radially outward from the illumination area relative to the first detection zone;

providing photons with said near-infrared light source; and

sequentially passing the photons through the illumination area into a portion of the subject and out of the subject through the detection area to said set of detectors.

16. The method of claim 15, further comprising the steps of:

collecting light using the first detection zone, the first detection zone at least partially circumferentially encircling the illumination area, the first detection zone optically linked to a first set of detectors; and

collecting light using the second detection zone, the second detection zone at least partially circumferentially encircling the illumination area, the second detection zone optically linked to a second set of detectors.

17. The method of claim 16, further comprising the step of:

using signals from said first set of detectors to determine an outlier signal corresponding to a member of said signals, said outlier signal comprising a statistically significant difference from a mean signal generated from said signals, said first set of detectors comprising at least six detectors.

18. The method of claim 17, further comprising the step of:

using an algorithm to determine an analyte property of the sample, said algorithm discarding at least one response from a radially outward detector of said set of detectors, wherein said radially outward detector falls on a line passing through the illumination zone and an outlier detector generating said outlier signal.

19. The method of claim 17, further comprising the step of:

mathematically combining said signals from said first set of detectors after removal of the outlier signal, wherein said first set of detectors overlap a single radial distance from the illumination zone.