System for the physiological evaluation of brain function

• US 9,101,312 B2
• Filed: 02/19/2014
• Issued: 08/11/2015
• Est. Priority Date: 04/18/2012
• Status: Active Grant

• Current Assignee: TBI Diagnostics, LLC
• Original Assignee: TBI Diagnostics, LLC
• Inventors: Waldorf, Ronald A., Handmaker, Hirsch
• Primary Examiner(s): HASAN, MOHAMMED A
• Application Number:
  US14/184,465
• Publication Number:
  US 20140171756A1
• Time in Patent Office: 538 Days
• Field of Search: 351200-246
• US Class Current: 1/1
• CPC Class Codes: A61B 3/0083 provided with means for patient positioning
• CPC Class Codes: A61B 3/032 Devices for presenting test symbols or characters, e.g. test chart projectors A61B3/036 takes precedence
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 5/163 by tracking eye movement, gaze, or pupil change
• CPC Class Codes: A61B 5/4005 for evaluating the sensory system A61B5/12, A61B5/4058 take precedence
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

The OculoKinetic Device is used to test an individual to evaluate brain function including, but not limited to, identifying the presence of a traumatic brain injury or central nervous system disease which manifests itself through abnormal ocular responses to stimuli by using the high-speed tracking of an individual'"'"'s eye movements (monocular or binocular, and either conjugate or disconjugate in horizontal, vertical, or torsional directions or combinations thereof), pupil size and reactivity, eyelid position, and blink parameters, and optionally along with other ocular elements, i.e., eyeball pressure, temperature, blood flow, etc. The eye movement stimulus protocol uses a target that moves in any direction of a two- or three-dimensional plane and may use a color display or geometric shapes. In addition, the stimuli can be used in conjunction with cognitive testing, balance assessment, and other non-eye tests.

Claims

1. A method for computing a measure of the ocular response of a test subject, in response to predetermined stimuli, which are presented on a stimulus presentation display that can be viewed by the eyes of the test subject, for viewing by the test subject, comprising:

generating a stimulus including visual target movement in at least one of;

a random pattern, a discontinuous movement, and an oblique direction on the stimulus presentation display, for display to the test subject;

measuring, using an ocular measurement device, at least one of a temporal eye movement, a spatial eye movement, pupil size, and pupil reactivity of the test subject in responding to the visual stimulus presently displayed by the stimulus presentation device; and

computing a score representative of at least one of the measured ability of the test subject'"'"'s eyes to track the visual stimulus and the measured pupillary metrics of the test subject'"'"'s eyes, comprising;

scanning an iris of the test subject to generate a present set of iris characteristics that are unique to the test subject;

retrieving from a test subject database baseline data comprising a previously generated set of iris characteristics that are unique to the test subject;

determining a variance between the presently generated set of iris characteristics that are unique to the test subject and the retrieved baseline data comprising the previously generated set of iris characteristics that are unique to the test subject;

authenticating, in response to the presently generated set of iris characteristics that are unique to the test subject corresponding to the retrieved previously generated set of iris characteristics that are unique to the test subject, the identity of the test subject;

retrieving baseline data, indicative of the test subject'"'"'s previously measured ocular responses, from a database; and

determining a variance between the presently measured ability of the test subject'"'"'s ocular responses and the retrieved baseline data indicative of the test subject'"'"'s previously measured ocular responses.

2. The method of computing a measure of the ocular response of a test subject of claim 1, further comprising:

storing the presently generated set of iris characteristics that are unique to the test subject in the test subject database.

3. The method of computing a measure of the ocular response of a test subject of claim 1 wherein the step of scanning comprises:

mapping the striations of the test subject'"'"'s iris; and

plotting these distinct iris markings located on the test subject'"'"'s iris.

4. The method of computing a measure of the ocular response of a test subject of claim 3, further comprising:

storing the presently captured data of the test subject'"'"'s iris and the plotted distinct iris markings located on the test subject'"'"'s iris in the test subject database.

5. The method of computing a measure of the ocular response of a test subject of claim 1 wherein the step of measuring comprises:

calculating a speed, which may include rates of change of velocity, of the test subject'"'"'s eye in tracking movement of the visual stimulus.

6. The method of computing a measure of the ocular response of a test subject of claim 1 wherein the step of measuring comprises:

calculating the accuracy of the test subject'"'"'s eye in tracking movement of the visual stimulus.

7. The method of computing a measure of the ocular response of a test subject of claim 1 wherein the step of measuring comprises:

calculating the overshoot/undershoot of the test subject'"'"'s eye in tracking movement of the visual stimulus.

8. The method of computing a measure of the ocular response of a test subject of claim 1 wherein the visual stimuli are at least one of:

geometric shapes, multi-color images, or flashing images.

9. The method of computing a measure of the ocular response of a test subject of claim 1 wherein the step of comparing comprises:

retrieving baseline data indicative of the test subject'"'"'s abilities to track the visual stimulus from a test subject database; and

determining a variance between the measured ability of the test subject'"'"'s eyes to track the visual stimulus and the retrieved baseline data indicative of baseline values of the test subject'"'"'s abilities to track the visual stimulus.

10. The method of computing a measure of the ocular response of a test subject of claim 9 wherein the step of comparing further comprises:

converting the determined variance in ability to track the visual stimulus into a scaled score.

11. The method of computing a measure of the ocular response of a test subject of claim 10 wherein the step of comparing further comprises:

measuring at least one physiological characteristic of the test subject selected from the set of physiological characteristics including, but not limited to;

pupillography, cognition, balance test results, cognitive test results, blood pressure, and body temperature; and

determining a variance between at least one physiological characteristic of the test subject and retrieved baseline data indicative of baseline values of an individual'"'"'s at least one physiological characteristic of the test subject.

12. The method of computing a measure of the ocular response of a test subject of claim 11 wherein the step of comparing further comprises:

converting the determined variance in ability to track the visual stimulus combined with the determined variance in at least one physiological characteristic of the test subject into a scaled score.

13. The method of computing a measure of the ocular response of a test subject of claim 11 wherein the at least one physiological characteristic of the test subject comprises pupil size, pupil reaction to light stimulation, and hippus.

14. The method of computing a measure of the ocular response of a test subject of claim 11 wherein the at least one physiological characteristic of the test subject comprises blinks or ptosis.

15. A method for computing a measure of the ocular response of a test subject, in response to predetermined stimuli, which are presented on a stimulus presentation display of an ocular measurement device that can be seen by the eyes of the test subject, for viewing by the test subject, comprising:

generating a visual stimulus including visual target movement in at least one of a random pattern, a discontinuous movement, and an oblique direction on the stimulus presentation display, for display to the test subject;

generating, using the ocular measurement device, ocular response test data which measures at least one of the ability of the test subject'"'"'s eyes to track the visual stimulus and measured pupillary metrics of the test subject'"'"'s eyes indicative of at least one of a temporal eye movement, a spatial eye movement, pupil size, and pupil reactivity of the test subject in responding to the visual stimulus presently displayed by the stimulus presentation device; and

computing a score based on ocular response test data, comprising;

retrieving baseline data from a database, indicative of the test subject'"'"'s previously measured ocular response test data; and

determining a variance between the presently measured test subject'"'"'s ocular response test data and the retrieved baseline data indicative of the test subject'"'"'s previously measured ocular response test data.

16. The method of computing a measure of the ocular response of a test subject of claim 15, further comprising:

scanning an iris of the test subject to generate a present set of iris characteristics that are unique to the test subject;

retrieving from a test subject database a previously generated set of iris characteristics that are unique to the test subject;

comparing the presently generated set of iris characteristics that are unique to the test subject with the retrieved previously generated set of iris characteristics that are unique to the test subject; and

authenticating, in response to the presently generated set of iris characteristics that are unique to the test subject corresponding to the retrieved previously generated set of iris characteristics that are unique to the test subject, the identity of the test subject.

17. The method of computing a measure of the ocular response of a test subject of claim 16, further comprising:

storing the presently generated set of iris characteristics that are unique to the test subject in the test subject database.

18. The method of computing a measure of the ocular response of a test subject of claim 16 wherein the step of scanning comprises:

mapping the characteristics of the test subject'"'"'s iris; and

plotting distinct iris markings located on the test subject'"'"'s iris.

19. The method of computing a measure of the ocular response of a test subject of claim 18, further comprising:

storing the presently mapped characteristics of the test subject'"'"'s iris and the plotted distinct iris markings located on the test subject'"'"'s iris in the test subject database.

20. The method of computing a measure of the ocular response of a test subject of claim 15 wherein the step of generating ocular response test data comprises:

calculating a speed, which may include rates of change of velocity of the test subject'"'"'s eye in tracking movement of the visual stimulus.

21. The method of computing a measure of the ocular response of a test subject of claim 15 wherein the step of generating ocular response test data comprises:

calculating the accuracy of the test subject'"'"'s eye in tracking movement of the visual stimulus.

22. The method of computing a measure of the ocular response of a test subject of claim 15 wherein the step of generating ocular response test data comprises:

calculating the overshoot/undershoot, i.e., Accuracy, of the test subject'"'"'s eye in tracking movement of the visual stimulus.

23. The method of computing a measure of the ocular response of a test subject of claim 15 wherein the visual stimuli are at least one of geometric shapes, multi-color images, or flashing images.

24. The method of computing a measure of the ocular response of a test subject of claim 15 wherein the step of comparing comprises:

retrieving baseline data indicative of the test subject'"'"'s abilities to track the visual stimulus from a test subject database; and

determining a variance between the measured ability of the test subject'"'"'s eyes to track the visual stimulus and the retrieved baseline data indicative of baseline values of the test subject'"'"'s abilities to track the visual stimulus.

25. The method of computing a measure of the ocular response of a test subject of claim 24 wherein the step of comparing further comprises:

converting the determined variance in ability to track the visual stimulus into a scaled score.

26. The method of computing a measure of the ocular response of a test subject of claim 25 wherein the step of comparing further comprises:

measuring at least one physiological characteristic of the test subject selected from the set of physiological characteristics including, but not limited to, pupillography, cognition, balance test results, cognitive test results, blood pressure, and body temperature; and

determining a variance between at least one physiological characteristic of the test subject and retrieved baseline data indicative of baseline values of an individual'"'"'s at least one physiological characteristic of the test subject.

27. The method of computing a measure of the ocular response of a test subject of claim 26 wherein the step of comparing further comprises:

converting the determined variance in ability to track the visual stimulus combined with the determined variance in at least one physiological characteristic of the test subject into a scaled score.

28. The method of computing a measure of the ocular response of a test subject of claim 26 wherein the at least one physiological characteristic of the test subject comprises pupil size, pupil reaction to light stimulation, and hippus.

29. The method of computing a measure of the ocular response of a test subject of claim 26 wherein the at least one physiological characteristic of the test subject comprises blinks or ptosis.