Apparatus and method for noninvasively monitoring for the presence of alcohol or substances of abuse in controlled environments

• US 7,616,123 B2
• Filed: 09/05/2006
• Issued: 11/10/2009
• 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, Maynard, John D., McNally, James, Abbink, Russell E.
• Primary Examiner(s): TRIEU, VAN THANH
• Application Number:
  US11/515,565
• Publication Number:
  US 20070073118A1
• Time in Patent Office: 1,162 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, 340/576, 600/310, 600/316, 600/322, 600/473, 436/501, 713/186
• US Class Current: 340/573.1
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• 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 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: G01J 3/02 Details
• CPC Class Codes: G01J 3/0218 using optical fibers
• CPC Class Codes: G01J 3/0291 Housings; Spectrometer accessories; Spatial arrangement of elements, e.g. folded path arrangements
• 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

The present invention relates generally to non-invasive methods and apparatuses for determining analyte properties of a subject and identity characteristics of a subject. Embodiments of the present invention provide analyte property determination and identity determination or verification from the same spectroscopic information, making unauthorized use or misleading results less likely that in systems that include 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;

b) An analysis system adapted to determine from the spectroscopic signal one or more analyte properties characteristic of the individual, wherein the analysis system is further adapted to determine an identity characteristic of the individual from the spectroscopic signal;

c) An action initiation system adapted to initiate an action responsive to the one or more analyte properties, wherein the action initiation system is adapted to initiate an action responsive to both the identity characteristic and the one or more analyte properties.

2. 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, or both.

3. An apparatus as in claim 1, wherein the action initiation system is adapted to communicate the one or more analyte properties to an agent associated with the controlled environment.

4. An apparatus as in claim 1, wherein the action initiation system is adapted to record the one or more analyte properties.

5. An apparatus as in claim 1, wherein the action initiation system is adapted to allow or disallow access to the controlled environment based on the one or more analyte properties.

6. An apparatus as in claim 1, wherein the action initiation system is adapted to communicate to an agent associated with the controlled environment the result of a comparison of the one or more analyte properties with predetermined values.

7. An apparatus as in claim 1, where the one or more analyte properties comprise the presence, concentration, or both of a substance of abuse in the individual.

8. An apparatus as in claim 1, where the spectroscopic system operates using one or more of:

near infrared absorption spectroscopy, near infrared emission spectroscopy, infrared absorption spectroscopy, infrared emission spectroscopy, Raman spectroscopy, visible absorption spectroscopy, or fluorescence spectroscopy.

9. An apparatus as in claim 1, wherein the analysis system is adapted to determine at least one analyte property using multivariate analysis of the spectroscopic signal.

10. An apparatus as in claim 9, wherein the multivariate analysis comprises using a neural network, K-nearest neighbors, discriminant analysis, classification analysis, principal components analysis, partial least squares regression, classical least squares regression, logistic regression, nonlinear regression, or a combination thereof.

11. 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.

12. An apparatus as in claim 1, where the identity characteristic comprises verification or nonverification of the purported identity of the subject.

13. An apparatus as in claim 12, 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.

14. An apparatus as in claim 1, 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.

15. An apparatus as in claim 14, where the authorized group consists of only one individual.

16. 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 faculties, or a power plant.

17. An apparatus as in claim 1, wherein the spectroscopic system comprises a dispersive spectrometer.

18. An apparatus as in claim 1, wherein the spectroscopic system comprises an interferometric/modulating spectrometer.

19. An apparatus as in claim 1, wherein the spectroscopic system comprises a combination of a dispersive spectrometer and an interferometric/modulating spectrometer.

20. 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.

21. An apparatus as in claim 20, wherein the analysis system is adapted to determine from the spectroscopic signal the presence of topical or chemical interferents by applying to the spectroscopic signal a model relating a spectroscopic signal to presence of an interferent, and from the result determining whether the spectrum indicates an interferent condition, and wherein the analysis system is adapted to determine the one or more analyte properties from the spectroscopic system and from the indicated interferent condition.

22. 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.

23. 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.

24. 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.

25. An apparatus as in claim 1, wherein the spectroscopic system comprises

a) an illumination subsystem;

b) a tissue sampling subsystem, in optical communication with the illumination subsystem;

c) a spectrometer subsystem in optical communication with the tissue sampling subsystem, said spectrometer subsystem including a spectrometer;

d) a data acquisition subsystem including a detector which receives an output from the spectrometer subsystem and converts said output to a communicable representation, said data acquisition subsystem including means for modifying said communicable representation and producing an analyzable representation thereof.

26. An apparatus as in claim 1, wherein the analysis system is adapted to determine at least one analyte property or identity characteristic using multivariate analysis of the spectroscopic signal.

27. 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;

b) An analysis system 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;

c) An output system adapted to communicate a signal responsive to the determination of the analysis system.

28. An apparatus as in claim 27, wherein the analysis system compares a determined indication of alcohol concentration with a predetermined threshold indication of alcohol concentration, and wherein the output system communicates the result of that comparison.

29. An apparatus as in claim 28, wherein the output system activates an alert signal if the determined indication of alcohol concentration exceeds the predetermined threshold indication of alcohol concentration.

30. An apparatus as in claim 27, wherein the output system records in persistent storage the determination by the analysis system.

31. An apparatus as in claim 27, wherein the output system communicates to a remote location the determination of the analysis system.

32. A method of monitoring the sobriety of individuals entering a treatment facility, comprising determining and recording with an apparatus as in claim 27 the presence or concentration of alcohol in the tissue of an individual and an identity characteristic, and, if the alcohol concentration exceeds a predetermined threshold or the identity characteristic is deemed incorrect, communicating and recording an alert signal.

33. A method of controlling access to a workplace by individuals, comprising determining with an apparatus as in claim 27 the presence or concentration of alcohol in the tissue of an individual and the identity of the individual, and, if the alcohol concentration exceeds a predetermined threshold, communicating an indication that access to the workplace by that individual be denied.

34. A method of monitoring compliance of a monitored individual with requirements related to verifying sobriety, comprising determining with an apparatus as in claim 27 the presence or concentration of alcohol in the tissue of a testing individual and an identity characteristic of the testing individual, and, if the alcohol concentration exceeds a predetermined threshold then communicating a corresponding signal to a remote agent, and, if the identity characteristic of the testing individual does not match the identity of the monitored individual, then communicating a corresponding signal to a remote agent.

35. A method as in claim 34, further comprising, if a testing individual has not been determined to have an acceptable alcohol concentration and an identity characteristic matching that of the monitored individual within a predetermined time, then communicating a corresponding signal to a remote agent.

36. A system for monitoring compliance with requirements related to alcohol or substance of abuse consumption, comprising a plurality of apparatuses as in claim 27 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.

37. 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 27 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.

38. A method of controlling access to a workplace by individuals, comprising determining with an apparatus as in claim 27 the presence or concentration of alcohol in the tissue of an individual and whether the individual belongs to a predetermined group of individuals, and, if the alcohol concentration exceeds a predetermined threshold or the individual does not belong to the predetermined group of individuals, then communicating an indication that access to the workplace by that individual be denied.