Multiplexed pathlength resolved noninvasive analyzer apparatus with dynamic optical paths and method of use thereof

• US 9,585,604 B2
• Filed: 09/22/2014
• Issued: 03/07/2017
• Est. Priority Date: 07/16/2012
• Status: Active Grant

• Current Assignee: Zyomed Holdings, Inc.
• Original Assignee: Zyomed Corp.
• Inventors: Ruchti, Timothy, Abul-Haj, Alan, Hazen, Kevin
• Primary Examiner(s): Makiya, David J
• Assistant Examiner(s): Jo, Taeho
• Application Number:
  US14/493,283
• Publication Number:
  US 20150011850A1
• Time in Patent Office: 897 Days
• Field of Search: 25033901-33909, 2503391-33914
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• 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: A61B 5/6801 specially adapted to be attached to or worn on the body surface

Abstract

A noninvasive analyzer apparatus and method of use thereof is described comprising a near-infrared source, a detector, and a photon transport system configured to direct photons from the source to the detector via an analyzer-sample optical interface. The photon transport system includes a dynamically position light directing unit used to, within a measurement time period for a single analyte concentration determination, change any of: radius, energy, intensity, position, incident angle, solid angle, and/or depth of penetration of a beam of photons entering skin of a subject.

Claims

1. A method for noninvasively determining an analyte concentration of a person, comprising the steps of:

providing a near-infrared analyzer, comprising;

at least one near-infrared source;

a detector; and

a photon transport system configured to direct photons from said source to said detector via an analyzer-sample optical interface;

dynamically changing, within a time window of data collection for a single analyte concentration determination, a mean radial illumination position of incident light from said near-infrared source relative to a center of said analyzer-sample optical interface; and

using a piezoelectrically positioned mirror to change a mean incident radial light path, relative to the center of said analyzer-sample optical interface, into the skin by at least twenty-five percent.

2. The method of claim 1, said step of dynamically changing a mean radial illumination position further comprising the steps of:

at a first time, directing light from said source to a first optic; and

at a second time, directing light from said source to a second optic, said second optic in a distinct optical path not using said first optic.

3. The method of claim 2, further comprising the step of:

within the time window for collection of data for determination of the single analyte concentration determination, changing an effective depth of penetration of the incident light into skin of the person by at least twenty percent.

4. The method of claim 3, further comprising the steps of:

at a first time, directing photons from said near-infrared source to a first subset of fiber optics in a fiber optic bundle; and

at a second time, directing photons from said near-infrared source to a second subset of fiber optics in said fiber optic bundle.

5. The method of claim 4, further comprising the step of:

using a rotatable and selectable opaque perimeter aperture to change a cross-sectional diameter of a light beam from said near-infrared source by at least twenty-five percent within the time window.

6. The method of claim 1, further comprising the step of:

using said piezoelectrically positioned mirror to change an incident angle of the incident light entering the skin of the subject by at least fifteen degrees.

7. The method of claim 1, said step of dynamically changing, within the time window of data collection for the single analyte concentration determination, the mean radial illumination position of incident light, further comprising the steps of:

at a first point in time, radially directing and positioning the incident light at a first radial distance from the center of the analyzer-subject interface yielding a median maximum depth of penetration in an epidermis layer of skin of the subject; and

at a second point in time, radially directing and positioning the incident light at a second radial distance from the center of the analyzer-subject interface yielding a mean maximum depth of penetration in a dermis layer of skin of the subject.

8. The method of claim 1, further comprising the steps of:

generating a subject specific tissue map; and

subsequently performing said step of dynamically changing a mean radial illumination position of the incident light using information from the subject-specific tissue map.

9. The method of claim 1, said step of dynamically changing a mean radial illumination position of the incident light further comprising the steps of:

delivering the incident light proximate at least one of;

an edge of a detector array; and

a corner of a detector array.

10. The method of claim 1, said step of dynamically changing a mean radial illumination position of the incident light further comprising the step of:

delivering the incident light sequentially to at least four optical fibers proximate at least one of;

an edge of a detector array; and

a corner of a detector array.

11. The method of claim 1, further comprising the step of:

dynamically changing, within the time window of data collection for the single analyte concentration determination, a solid angle of incident light striking the analyzer-tissue interface by greater than ten percent.

12. The method of claim 11, said step of dynamically changing a solid angle further comprising the step of:

within the time window, irradiating the subject with two solid angles of incident light overlapping by less than twenty percent.

13. An apparatus for noninvasively determining an analyte concentration of a person, comprising:

a near-infrared analyzer, comprising;

at least one near-infrared source;

a detector; and

a photon transport system configured to direct photons from said source to said detector via an analyzer-sample optical interface, said photon transport system further comprising;

means for dynamically changing, within a time period of data collection for a single analyte concentration determination, a radial illumination position of incident light from said near-infrared source relative to a center of said analyzer-sample optical interface, said means for dynamically changing the radial illumination position comprising a dynamically positioned optic system, said means for dynamically changing the radial position of the incident light, comprising;

a piezoelectrically controlled optic, said piezoelectrically controlled optic configured to change an effective depth of focus of the incident light by at least ten percent for said single analyte concentration determination.

14. The apparatus of claim 13, said means for dynamically changing the radial position of the incident light, comprising:

an electromechanically directed mirror.

15. The apparatus of claim 14, said detector further comprising:

a two-dimensional detector array comprising at least six, electrically connected in series, detector elements along an arc of at least forty-five degrees.

16. The apparatus of claim 13, said means for dynamically changing the radial position of the incident light comprising an array of light emitting diodes at least eighty percent circumferentially surrounded by said detector at the analyzer-sample optical interface, said detector comprising at least one detector array.