DYNAMIC RADIALLY CONTROLLED LIGHT INPUT TO A NONINVASIVE ANALYZER APPARATUS AND METHOD OF USE THEREOF

• US 20150015888A1
• Filed: 07/12/2013
• Published: 01/15/2015
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: Zyomed Holdings, Inc.
• Original Assignee: Zyomed Corp.
• Inventors: Gulati, Sandeep, George, Thomas, Ruchti, Timothy, Abul-Haj, Alan, Hazen, Kevin H.
• Granted Patent: US 9,766,126 B2
• Time in Patent Office: Days
• US Class Current: 356/446
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: G01J 3/42 Absorption spectrometry; Double beam spectrometry; Flicker spectrometry; Reflection spectrometry beam switching arrangements G01J3/08
• CPC Class Codes: G01N 2021/4742 comprising optical fibres
• CPC Class Codes: G01N 2021/4747 Concentric bundles
• CPC Class Codes: G01N 21/474 Details of optical heads therefor, e.g. using optical fibres
• CPC Class Codes: G01N 2201/0826 Fibre array at source, distributing

Abstract

An analyzer apparatus and method of use thereof is described to dynamically irradiate a sample with incident light where the incident light is varied in time in terms of any of: position, radial position relative to a point of the skin of a subject, solid angle, incident angle, depth of focus, energy, and/or intensity. For example, the incident light is varied in radial position as a function of time relative to one or more of a sample site, a point on skin of the subject, a detection optic, and/or a sample volume observed by a detection system. The radially varied incident light is used to enhance and/or vary light probing the epidermis, the dermis, and/or the subcutaneous fat of the subject or of a group of subjects.

Claims

1. An apparatus for noninvasively determining an analyte concentration at a sample site of a subject, comprising:

a noninvasive analyzer, comprising;

a source configured to provide photons;

means for independently irradiating as a function of time each member of a set of mean radial distances from a center of the sample site of the subject with the photons,

wherein a first member of said set of mean radial distances, comprises a first distance of less than two and a half millimeters and greater than six hundred micrometers,

wherein a second member of said set of mean radial distances comprises a second distance of less than one millimeter and greater than one-quarter millimeter, and

wherein a third member of said set of mean radial distances comprises a third distance of less than one-half millimeter; and

a detector configured to sequentially detect the photons traversing through each member of said set of mean radial distances independently of remaining members of said set of mean radial distances, said analyzer configured to use the detected photons in determination of the analyte concentration.

2. The apparatus of claim 1, wherein said means for independently irradiating comprises:

a fiber optic bundle, comprising a set of irradiation fiber optics configured at at least three radial distances from at least one collection fiber optic; and

means for sequentially irradiating each of;

a first fiber, a second fiber, and a third fiber of said set of irradiation fiber optics with the photons.

3. The apparatus of claim 2, wherein said means for sequentially irradiating comprises:

a mask element, said mask element configured to selectively mask individual groups of fibers of said set of irradiation fiber optics from the photons from said source as a function of time.

4. The apparatus of claim 2, wherein said means for sequentially irradiating comprises:

a tiltable optic configured to selectively irradiate, as a function of time, at least four fiber subsets of said set of irradiation fiber optics using the photons from said source as a function of time.

5. The apparatus of claim 1, wherein said means for sequentially irradiating comprises:

a tiltable optic configured to, during use, dynamically direct the photons along two axes to selected separately and distinctly positioned zones of a grid, the grid forming a plane both perpendicular to the sample site and tangentially contacting the sample site.

6. The apparatus of claim 1, said means for independently irradiating as a function of time further comprising a computer controlled tiltable optic configured to:

irradiate the subject with the photons at a first mean angle off of a first axis perpendicular to the subject at the first distance of said set of mean radial distances; and

subsequently irradiate the subject with the photons at a second mean angle off of a second axis perpendicular to the subject at the second distance of said set of mean radial distances, wherein the first mean angle and the second mean angle differ by at least ten degrees.

7. The apparatus of claim 6, said computer control tiltable optic further configured to:

irradiate the subject with the photons at a third mean angle off of a third axis perpendicular to the subject at the third distance of said set of mean radial distances,

wherein the first mean angle and the third mean angle differ by at least ten degrees, and

wherein the second mean angle and the third mean angle differ by at least five degrees.

8. The apparatus of claim 1, said means for independently irradiating comprising a controller of said noninvasive analyzer configured to, as a function of time while analyzing a subject, move an optic of said analyzer to vary a focal plane used to direct the photons to at least one member of a set of mean radial distances from the center of the sample site of the subject.

9. The apparatus of claim 1, said means for independently irradiating further comprising an imager configure to:

selectively target valleys of an epidermal ridge of the subject with a greater number of the photons compared to a lesser number of the photons delivered to the epidermal ridge.

10. The apparatus of claim 1, said means for independently irradiating further comprising an optic configured to alter an axial cross-sectional area of a beam shape of the photons to each of:

a first cross-sectional area when irradiating at the first distance of said set of mean radial distances,

a second cross-sectional area when irradiating at the second distance of said set of mean radial distances, and

a third cross-sectional area when irradiating at the third distance of said set of mean radial distances.

11. The apparatus of claim 1, said analyzer further comprising:

a fiber optic bundle comprising;

a first irradiation fiber optic comprising a first axial cross-sectional area; and

a second irradiation fiber optic comprising a second axial cross-sectional area, said second cross-sectional area at least twenty percent larger than said first cross-sectional area, both said first irradiation fiber optic and said second irradiation fiber optic configured to receive the photons.

12. The apparatus of claim 11, said fiber optic bundle further comprising:

a sample light collection optic configured to optically connect to said detector, wherein said first fiber optic comprises a first physical separation distance from said sample light collection optic at an interface of the fiber optic bundle to the subject, wherein said second fiber optic comprises a second physical separation distance from said light collection optic at the interface of the fiber bundle to the subject, said second physical separation distance at least twice said first physical separation distance.

13. The apparatus of claim 1, wherein the photons transmitting through a subject/analyzer interface at:

the first distance, wherein the first distance correlates to a first mean maximum depth path into a subcutaneous fat layer of skin of the subject; and

the third distance, wherein the third distance correlates to a second mean path maximum depth path through an epidermis layer of skin of the subject without penetrating to the subcutaneous fat layer of the skin of the subject.

14. A method for noninvasively determining an analyte concentration at a sample site of a subject, comprising the steps of:

using a source of an analyzer to provide photons;

guiding the photons with a photon transport system to a set of mean radial distances from a center of the sample site of the subject;

wherein a first member of said set of mean radial distances, comprises a first distance of less than two and a half millimeters and greater than six hundred micrometers,

wherein a second member of said set of mean radial distances comprises a second distance of less than one millimeter and greater than one-half millimeter, and

wherein a third member of said set of radial distances comprises a third distance of less than one-half millimeter; and

sequentially detecting the photons traversing through each of said first member, said second member, and said third member of said set of mean radial distances independently of detection of the photons of remaining member distances of said first member, said second member, and said third member of said set of mean radial distances.

15. The method of claim 14, further comprising the step of:

using a data processing system to determine a mean radial distance of the photons comprising a mean maximum depth penetrating into subcutaneous fat of the subject using the detected photons.

16. The method of claim 14, further comprising the steps of:

irradiating the subject with the photons at a first mean angle off of an axis perpendicular to the sample site at the first distance of said set of mean radial distances; and

irradiating the subject with the photons at a second mean angle relative to the axis perpendicular to the sample site at the second distance of said set of mean radial distances,

wherein the first mean angle and the second mean angle differ by at least ten degrees.

17. The method of claim 14, further comprising the steps of, during analysis of the subject:

selectively irradiating at the first distance of the sample site by tilting an optic of said photon transport system to a first position; and

subsequently selectively irradiating at the second distance to the sample site by tilting said optic of said photon transport system to a second position.

18. The method of claim 14, further comprising the step of, during analysis of the subject:

changing a focus length of an optic of said photon transport system from a first length to a second length,

wherein said step of sequentially detecting operates during a first period with said optic configured at said first length and during a second subsequent period with said optic configured at said second length.

19. The method of claim 14, further comprising the steps of, during analysis of the subject:

clipping an outer perimeter of a beam path of the photons to form a first axial cross-sectional area at a first location at a first point in time; and

clipping an outer perimeter of the beam path to form a second axial cross-sectional area at the first location at a second point in time,

wherein the first axial cross-sectional area is at least thirty percent larger than the second axial cross-sectional area.

20. The method of claim 14, further comprising the steps of, during analysis of the subject:

concentrating the photons to a first intensity per unit area at a first interface to an outer surface of skin of the subject during a first period of time; and

concentrating the photons to a second intensity per unit area at a second interface to the subject during a second period of time,

wherein the first intensity comprises at least fifty percent more photons per unit area than the second intensity.