ANS assessment systems, kits, and methods

• US 10,791,924 B2
• Filed: 08/07/2015
• Issued: 10/06/2020
• Est. Priority Date: 08/10/2014
• Status: Active Grant

• Current Assignee: Autonomix Medical, Inc.
• Original Assignee: Autonomix Medical, Inc.
• Inventors: Toth, Landy, Schwartz, Robert S.
• Primary Examiner(s): Abouelela, May A
• Application Number:
  US15/503,180
• Publication Number:
  US 20170231490A1
• Time in Patent Office: 1,887 Days
• Field of Search: 600300, 600558, 351206, 351246, 351209, 606 10, 606 13
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• CPC Class Codes: A61B 2018/00434 Neural system
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• CPC Class Codes: A61B 2018/1861 with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 3/0025 characterised by electronic signal processing, e.g. eye models
• CPC Class Codes: A61B 3/0033 characterised by user input arrangements
• CPC Class Codes: A61B 3/0041 characterised by display arrangements
• CPC Class Codes: A61B 3/113 for determining or recording eye movement
• CPC Class Codes: A61B 3/14 Arrangements specially adapted for eye photography apparatus or arrangements for taking photographs per se G03B
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/0051 by applying vibrations
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• CPC Class Codes: A61B 5/02055 : Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 : Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02405 : Determining heart rate variability
• CPC Class Codes: A61B 5/026 : Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0261 : using optical means, e.g. infrared light
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• CPC Class Codes: A61B 5/1075 : for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer A61B8/0858 takes precedence
• CPC Class Codes: A61B 5/1079 : using optical or photographic means
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• CPC Class Codes: A61B 5/14551 : for measuring blood gases
• CPC Class Codes: A61B 5/16 : Devices for psychotechnics using teaching or educational appliances G09B1/00 - G09B7/00; Testing reaction times ; Devices for evaluating the psychological state
• CPC Class Codes: A61B 5/163 : by tracking eye movement, gaze, or pupil change
• CPC Class Codes: A61B 5/165 : Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/259 : using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/318 : Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/389 : Electromyography [EMG]
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• CPC Class Codes: A61B 5/40 : Detecting, measuring or recording for evaluating the nervous system A61B5/4806, A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/4035 : Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/486 : Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/4884 : inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61B 5/6803 : Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/6814 : Head
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/721 : using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/7221 : Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/744 : Displaying an avatar, e.g. an animated cartoon character
• CPC Class Codes: A61B 5/7445 : Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/745 : using a holographic display
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61F 2007/0075 : using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 7/007 : characterised by electric heating
• CPC Class Codes: A61M 5/00 : Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61N 1/36014 : External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
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• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/70 : for mining of medical data, e.g. analysing previous cases of other patients

Abstract

Systems, devices, methods, and kits for monitoring one or more physiologic and/or physical signals from a subject are disclosed. A system including a head mounted display to monitor one or more physiologic signals from the face or head of the subject is disclosed. A method for analyzing an ocular parameter of the subject to determine a sympathetic and a parasympathetic outflow thereto is disclosed.

Claims

1. A method for assessing at least one of sympathetic and parasympathetic neural activity in an eye of a subject, the method being performed by at least one processing device coupled to one or more back-facing image sensors of a head-mounted display the method comprising:

taking a plurality of images of the eye over a period of time utilizing the one or more back-facing image sensors of the head-mounted display;

identifying and tracking a position of a plurality features of an iris of the eye across the plurality of images to generate a plurality of trajectories, each of the plurality of trajectories characterizing the position of at least one of the plurality of features of the iris of the eye over the period of time;

analyzing the plurality of trajectories to determine a relative movement between two or more features of the iris of the eye;

generating at least one corrected movement of at least one of the two or more features of the iris of the eye based at least in part on the determined relative movement between the two or more features of the iris of the eye to correct for a series mechanical interconnection of sphincter and dilator muscles of the eye; and

utilizing the at least one corrected movement to generate one or more metrics relating to at least one of sympathetic and parasympathetic neural activity in the eye.

2. The method in accordance with claim 1, wherein the plurality of features of the iris comprise two or more of a ciliary zone, a pupil, a sphincter muscle/pupillary zone, a crypt, a peripheral crypt, a contraction furrow, a mole, a region of alternative/distinct color, a color distorted region, a region of contrast, an identifiable region, a diameter, boundary, centroid, area, and distortion.

3. The method in accordance with claim 1, wherein the position of one or more of the plurality of features is calculated relative to a reference point in the plurality of images, the reference point being substantially a center of a pupil of the eye.

4. The method in accordance with claim 3, wherein one or more of the plurality of trajectories comprises at least one of a radial movement and a rotational movement about the reference point.

5. The method in accordance with claim 1, further comprising altering a light field near to one or more of the plurality of features in one or more of the plurality of images, wherein altering the light field occurs over an optical spectrum visible in the images but without substantially impacting a light reflex of the eye.

6. The method in accordance with claim 1, further comprising administering a medicament to the eye to affect at least one of a parasympathetic muscular response and a sympathetic muscular response of the eye, the medicament comprising at least one of an anticholinergic agent, an alpha andrenergic agent, a muscarinic receptor agonist, and a sympathomimetic agent.

7. The method in accordance with claim 1, further comprising performing a stress test on the subject at least one of before and during the tracking, the one or more metrics being related to a response of the subject to the stress test.

8. The method in accordance with claim 1, further comprising:

treating a target site within the subject, the one or more metrics being related to a response of the subject to the treatment of the target site; and

administering at least one of a subsequent treatment and a stress test to the target site, wherein the one or more metrics at least one of during and after said at least one of the subsequent treatment and the stress test being indicative of a state of completion of the treatment of the target site.

9. The method in accordance with claim 1, wherein generating the at least one corrected movement converts movement of the at least one feature based at least in part on coupling of the sphincter and dilator muscles to each other and the sphincter and dilator muscles being substantially anchored to the eye at an edge of the iris.

10. The method in accordance with claim 9, wherein the edge of the iris comprises an interface between the iris and a sclera of the eye.

11. The method in accordance with claim 1, wherein analyzing the plurality of trajectories comprises independently determining sphincter muscle related movement and dilator muscle related movement.

12. The method in accordance with claim 11, wherein determining the sphincter muscle related movement is based at least in part on determining relative movement between two or more of the plurality of features located in a vicinity of a pupil, and wherein determining the dilator muscle related movement is based at least in part on determining relative movement between two or more of the plurality of features located in a vicinity of an edge of the iris.

13. The method in accordance with claim 12, further comprising utilizing the determined sphincter muscle related movement to generate one or more metrics related to parasympathetic nervous system (PNS) outflow to the eye and utilizing the identified dilator muscle movement to generate one or more metrics related to sympathetic nervous system (SNS) outflow to the eye.

14. A system for assessing at least one of sympathetic and parasympathetic neural activity in an eye of a subject, the system comprising:

a head-mounted display comprising one or more back-facing image sensors; and

at least one processing device coupled to the one or more back-facing image sensors;

the at least one processing device being configured;

to utilize the one or more back-facing image sensors to take a plurality of images of the eye over a period of time;

to identify and track a position of a plurality features of an iris of the eye across the plurality of images to generate a plurality of trajectories, each of the plurality of trajectories characterizing the position of at least one of the plurality of features of the iris of the eye over the period of time;

to analyze the plurality of trajectories to determine a relative movement between two or more features of the iris of the eye;

to generate at least one corrected movement of at least one of the two or more features of the iris of the eye based at least in part on the determined relative movement between the two or more features of the iris of the eye to correct for a series mechanical interconnection of sphincter and dilator muscles of the eye; and

to utilize the at least one corrected movement to generate one or more metrics relating to at least one of sympathetic and parasympathetic neural activity in the eye.

15. The system in accordance with claim 14, wherein the plurality of features of the iris comprise two or more of a ciliary zone, a pupil, a sphincter muscle/pupillary zone, a crypt, a peripheral crypt, a contraction furrow, a mole, a region of alternative/distinct color, a color distorted region, a region of contrast, an identifiable region, a diameter, boundary, centroid, area, and distortion.

16. The system in accordance with claim 14, wherein the position of one or more of the plurality of features is calculated relative to a reference point in the plurality of images, the reference point being substantially a center of a pupil of the eye.

17. The system in accordance with claim 16, wherein one or more of the plurality of trajectories comprises at least one of a radial movement and a rotational movement about the reference point.

18. The system in accordance with claim 14, wherein the at least one processing device is further configured to alter a light field near to one or more of the plurality of features in one or more of the plurality of images, wherein altering the light field occurs over an optical spectrum visible in the images but without substantially impacting a light reflex of the eye.

19. The system in accordance with claim 14, wherein generating the at least one corrected movement converts movement of the at least one feature based at least in part on coupling of the sphincter and dilator muscles coupled to each other and the sphincter and dilator muscles being substantially anchored to the eye at an edge of the iris.

20. The system in accordance with claim 19, wherein the edge of the iris comprises an interface between the iris and a sclera of the eye.

21. The system in accordance with claim 14, wherein analyzing the plurality of trajectories comprises independently determining sphincter muscle related movement and dilator muscle related movement.

22. The system in accordance with claim 21, wherein determining the sphincter muscle related movement is based at least in part on determining relative movement between two or more of the plurality of features located in a vicinity of a pupil, and wherein determining the dilator muscle related movement is based at least in part on determining relative movement between two or more of the plurality of features located in a vicinity of an edge of the iris.

23. The system in accordance with claim 22, wherein the at least one processing device is further configured:

to utilize determined relative movement between two or more of the plurality of features located in a vicinity of the pupil to identify the sphincter muscle related movement; and

to utilize determined relative movement between two or more of the plurality of features located in a vicinity of an edge of the iris to identify the dilator muscle movement.

24. The system in accordance with claim 23, wherein the at least one processing device is further configured to utilize the identified sphincter muscle related movement to generate one or more metrics related to parasympathetic nervous system (PNS) outflow to the eye and utilizing the identified dilator muscle movement to generate one or more metrics related to sympathetic nervous system (SNS) outflow to the eye.