System for noninvasive determination of analytes in tissue

• US 8,174,394 B2
• Filed: 09/17/2009
• Issued: 05/08/2012
• Est. Priority Date: 04/11/2001
• Status: Expired due to Term

• Current Assignee: Rockley Photonics Limited
• Original Assignee: TruTouch Technologies, Inc.
• Inventors: Ridder, Trent, ver Steeg, Ben, Mills, Mike, Laaksonen, Bentley, McNally, James, Maynard, John, Abbink, Russell
• Primary Examiner(s): TRIEU, VAN THANH
• Application Number:
  US12/562,050
• Publication Number:
  US 20100010325A1
• Time in Patent Office: 964 Days
• Field of Search: 340/573.1, 340/573.4, 340/573.5, 340/573.7, 340/552, 340/554, 340/555, 340/557, 340/567, 340/575, 340/576, 340/5.2, 340/5.53, 340/5.83, 600/310, 600/312, 600/316, 600/322, 600/473, 600/476, 702/104, 250/339.08, 250/339.09, 250/573
• US Class Current: 340/573.1
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/0088 for oral or dental tissue
• 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 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4845 Toxicology, e.g. by detection of alcohol, drug or toxic products A61B5/4848 takes precedence
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: G01J 2003/1286 Polychromator in general
• CPC Class Codes: G01J 3/02 Details
• CPC Class Codes: G01J 3/0205 Optical elements not provided otherwise, e.g. optical manifolds, diffusers, windows
• CPC Class Codes: G01J 3/0218 using optical fibers
• CPC Class Codes: G01J 3/0229 using masks, aperture plates, spatial light modulators or spatial filters, e.g. reflective filters
• CPC Class Codes: G01J 3/0291 Housings; Spectrometer accessories; Spatial arrangement of elements, e.g. folded path arrangements
• CPC Class Codes: G01J 3/14 using refracting elements, e.g. prisms G01J3/18, G01J3/26 take precedence prisms per se G02B5/04
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 21/474 Details of optical heads therefor, e.g. using optical fibres
• CPC Class Codes: G01N 2201/129 Using chemometrical methods

Abstract

An apparatus and method for noninvasive determination of analyte properties of human tissue by quantitative infrared spectroscopy to clinically relevant levels of precision and accuracy. The system includes subsystems optimized to contend with the complexities of the tissue spectrum, high signal-to-noise ratio and photometric accuracy requirements, tissue sampling errors, calibration maintenance problems, and calibration transfer problems. The subsystems can include an illumination/modulation subsystem, a tissue sampling subsystem, a data acquisition subsystem, a computing subsystem, and a calibration subsystem. The invention can provide analyte property determination and identity determination or verification from the same spectroscopic information, making unauthorized use or misleading results less likely than in systems that use separate analyte and identity determinations. The invention can be used to control and monitor individuals accessing controlled environments.

Claims

1. An apparatus for initiating an action responsive to an individual entering or leaving or attempting to enter or leave a controlled environment, comprising:

a) a spectroscopic system adapted to determine a spectroscopic signal from the response of at least a portion of the individual'"'"'s tissue to incident electromagnetic radiation, wherein the spectroscopic system comprises;

i) an illumination/modulation subsystem;

ii) a tissue sampling subsystem;

iii) a data acquisition subsystem;

iv) an analysis subsystem adapted to determine from the spectroscopic signal one or more analyte properties characteristic of the individual; and

v) a calibration subsystem;

b) an action initiation system adapted to initiate an action responsive to the one or more analyte properties.

2. An apparatus as in claim 1, wherein the analysis system is further adapted to determine an identity characteristic of the individual from the spectroscopic signal, and wherein the action initiation system is adapted to initiate an action responsive to both the identity characteristic and the one or more analyte properties.

3. An apparatus as in claim 2, where the identity characteristic comprises verification or nonverification of the purported identity of the subject.

4. An apparatus as in claim 3, further comprising an identity input system comprising at least one of:

an alphanumeric password entry device, a key input device, a magnetic swipe card reader, a GPS location device, a finger print reader, a voice recognition system, a retina scanner, bar code scanner, or an implanted sensor or material.

5. An apparatus as in claim 2, where the identity characteristic comprises determination of whether the individual is part of a predetermined group, without requiring the individual to indicate a purported identity.

6. An apparatus as in claim 5, where the authorized group consists of only one individual.

7. An apparatus as in claim 1, wherein the one or more analyte properties comprises the presence of alcohol or one or more alcohol byproducts in the individual;

the concentration of alcohol or one or more alcohol byproducts in the individual;

the presence of a substance of abuse in the individual;

the concentration of a substance of abuse in the individual;

or a combination of the preceding.

8. An apparatus as in claim 1, wherein the action initiation system is adapted to perform at least one of:

communicate the one or more analyte properties to an agent associated with the controlled environment;

record the one or more analyte properties;

allow or disallow access to the controlled environment based on the one or more analyte properties;

or communicate to an agent associated with the controlled environment the result of a comparison of the one or more analyte properties with predetermined values.

9. An apparatus as in claim 1, wherein the portion of the individual'"'"'s tissue comprises at least one of:

the finger, forearm, ear lobe, palm, lip, hand, or skin of the individual.

10. An apparatus as in claim 1, where the controlled environment or site is one of:

a hospital, area of a hospital, surgical suite, prison, area of a prison, jail, health clinic, dental office, aircraft cockpit, airport terminal, area of an airport, automobile, a truck, a bus, parole office, probation office, court building, courtroom, home arrest location, residential treatment center, office building, warehouse, storage facility, office or offices within a building, factory, regions within a factory, construction site, sports facility, recreational facility, amusement park, school, school activity site, dormitory, restaurant, bar, club, day care facility, ship, military installation, roadside stop, traffic accident site, DUI checkpoint, train control room, train, research facilities, laboratories, maintenance facilities, classified facilities, air traffic control facility, security center, historic sites, parks, machine shop, dispatch office, dispatch center, garages, school bus facilities, a space from which alcohol is accessed, or a power plant.

11. An apparatus as in claim 1, wherein the analysis system is adapted to determine from the spectroscopic signal the presence of topical or chemical interferents.

12. An apparatus as in claim 1, wherein the analysis system determines the one or more analyte properties in part by correcting, filtering, or adjusting the spectroscopic signal for topical or chemical interferents.

13. An apparatus as in claim 1, wherein the spectroscopic system is adapted to determine the response of the portion of tissue at a single distribution of path lengths through the portion of tissue.

14. An apparatus as in claim 1, wherein the spectroscopic system is adapted to determine the response of the portion of tissue at a first distribution of path lengths through the tissue, and at a second distribution of path lengths through the tissue, wherein the second distribution of path lengths is different from the first distribution of path lengths.

15. An apparatus as in claim 1, wherein:

a) the illumination/modulation subsystem comprises a plurality of light sources, wherein each light source emits light at a different narrow range of wavelengths, and a modulator for modulating the intensity of each of the light sources;

b) the tissue sampling subsystem is adapted to introduce the light emitted by the illumination subsystem into the tissue of the subject and to collect an optical output signal comprising the portion of the light not absorbed by the tissue; and

c) the data acquisition subsystem comprises a single element detector adapted to detect the optical output signal as a function of time.

16. An apparatus as in claim 1, wherein the illumination/modulation subsystem comprises at least one of a solid state light source, a light emitting diode, a vertical cavity surface emitting laser, or a quantum cascade laser.

17. An apparatus as in claim 1, wherein the illumination/modulation subsystem comprises a plurality of solid state light sources, each modulated in intensity at a frequency different from that of at least one other of said light sources, and with the output of the plurality of light sources optically combined into a single beam.

18. An apparatus as in claim 1 wherein the illumination/modulation subsystem comprises one or more solid state light sources, and electronic circuitry to control at least one of the drive current, the drive voltage, or the temperature of the solid state light source.

19. An apparatus as in claim 1, wherein the illumination/modulation subsystem comprises a plurality of solid state light sources, and a light homogenizer that accepts light from the solid state light sources and provide angular homogenization, spatial homogenization, or both, of the light.

20. An apparatus as in claim 1, wherein the illumination/modulation subsystem produces illumination light at a plurality of wavelengths, and wherein the illumination/modulation subsystem comprises an etalon with transmission peaks at wavelengths desired for the spectroscopic signal, or a dispersive grating configured to encode the wavelengths into separate spatial locations.

21. An apparatus as in claim 1, wherein the tissue sampling subsystem is adapted to communicate light with a hand of a subject.

22. An apparatus as in claim 1, wherein the tissue sampling subsystem is adapted to communicate light with the top of one or more fingers of a subject, between the first and second knuckles of said finger or fingers.

23. An apparatus as in claim 1, wherein the tissue sampling subsystem is adapted to communicate light multiple sample locations on the skin of a subject.

24. An apparatus as in claim 1, wherein the analysis system comprises a model relating spectroscopic signal to analyte property, and wherein the analysis system is adapted to modify the model responsive to spectroscopic signals acquired from individuals with presumed analyte properties.

25. An apparatus for monitoring compliance of an individual with requirements relating to the consumption of alcohol, comprising:

a) a spectroscopic system adapted to determine a spectroscopic signal from the response of at least a portion of the individual'"'"'s tissue to incident electromagnetic radiation, wherein the spectroscopic system comprises;

i) an illumination/modulation subsystem;

ii) a tissue sampling subsystem;

iii) a data acquisition subsystem;

iv) an analysis subsystem adapted to determine from the spectroscopic signal the presence, concentration, or both, of alcohol or an alcohol byproduct in the individual'"'"'s tissue, and further adapted to determine an identity characteristic of the individual from the spectroscopic signal; and

v) a calibration subsystem;

b) an output system adapted to communicate a signal responsive to the determination of the analysis system.

26. An apparatus as in claim 25, wherein:

a) the illumination/modulation subsystem comprises a plurality of light sources, wherein each light source emits light at different narrow range of wavelengths, and a modulator for modulating the intensity of each of the light sources;

b) the tissue sampling subsystem is adapted to introduce the light emitted by the illumination subsystem into the tissue of the subject and to collect an optical output signal comprising the portion of the light not absorbed by the tissue; and

c) the data acquisition subsystem comprises a single element detector adapted to detect the optical output signal as a function of time.

27. An apparatus as in claim 25, wherein the illumination/modulation subsystem comprises at least one of a solid state light source, a light emitting diode, a vertical cavity surface emitting laser, or a quantum cascade laser.

28. An apparatus as in claim 25, wherein the illumination/modulation subsystem comprises a plurality of solid state light sources, each modulated in intensity at a frequency different from that of at least one other of said light sources, and with the output of the plurality of light sources optically combined into a single beam.

29. An apparatus as in claim 25 wherein the illumination/modulation subsystem comprises one or more solid state light sources, and electronic circuitry to control at least one of the drive current, the drive voltage, or the temperature of the solid state light source.

30. An apparatus as in claim 25, wherein the illumination/modulation subsystem comprises a plurality of solid state light sources, and a light homogenizer that accepts light from the solid state light sources and provide angular homogenization, spatial homogenization, or both, of the light.

31. An apparatus as in claim 25, wherein the illumination/modulation subsystem produces illumination light at a plurality of wavelengths, and wherein the illumination/modulation subsystem comprises an etalon with transmission peaks at wavelengths desired for the spectroscopic signal, or a dispersive grating configured to encode the wavelengths into separate spatial locations.

32. A system for monitoring compliance with requirements related to alcohol or substance of abuse consumption, comprising a plurality of apparatuses as in claim 25 disposed in a plurality of locations remote from each other, with each such apparatus connected to a communication system, wherein each such apparatus is adapted to communicate to a remote monitor the identity and the alcohol status of an individual presenting to the apparatus.

33. A method of remotely monitoring compliance of a plurality of individuals with requirements related to alcohol consumption, comprising disposing a plurality of apparatuses as in claim 25 in a plurality of locations remote from each other, determining with one of such apparatuses the identity and alcohol status of an individual presenting to the apparatus, and communicating the determined identity and determined alcohol status to a remote monitor, and wherein each of the plurality of individuals can present to any of the plurality of apparatuses.

34. An apparatus as in claim 25, wherein the analysis system comprises a model relating spectroscopic signal to presence, concentration, or both, of alcohol or an alcohol byproduct in the individual'"'"'s tissue, and wherein the analysis system is adapted to modify the model responsive to spectroscopic signals acquired from individuals with presumed zero presence or concentration of alcohol or an alcohol byproduct in the individual'"'"'s tissue.