Granted Patent B2

US 12,502,110 · App. 18/493,007 · Granted Dec 23, 2025

Inventors: Michael Kowalczyk (Boston, MA); Dexter Ang (Boston, MA); Henry Valk (Boston, MA); David Cipoletta (Boston, MA); Xiaofeng Tan (Boston, MA); Adam Helbling (Boston, MA); Michael Kasparian (Boston, MA)

Assignee: Pison Technology, Inc.

A61B5/162A61B5/165A61B5/256A61B5/294A61B5/311A61B5/388A61B5/7225A61B5/742G06F3/015G06F3/017A61B5/0002A61B2560/045A61B2560/0468A61B2562/0219A61B2562/046A61B2562/164A61B2562/227

Abstract

Claims (42)

1 . A system for assessing a physiological state of a user based at least in part on biopotentials detected at an external surface of a skin portion of the user, the system comprising:

a wearable device configured to be worn by the user, the wearable device comprising:

one or more electrodes configured to be disposed adjacent to an external surface of the skin portion, wherein the skin portion is disposed at a body portion comprising peripheral nerve tissue that is biologically coupled to a central nervous system of the user; and

one or more processors;

wherein the system is configured to:

obtain, using the one or more electrodes, biopotential signals generated at least in part by the peripheral nerve tissue;

determine a first timestamp, the first timestamp indicating a first time at which a stimulus is presented to the user;

determine a second timestamp, the second timestamp indicating a second time at which the biopotential signals indicate an intention by the user to perform a responsive action in response to the stimulus;

based at least on the first timestamp and the second timestamp, determine a subject response time for the user; and

compare the subject response time for the user, or one or more values based thereon, to at least a baseline response time determined based at least in part on (i) one or more prior reaction time tests for the user or (ii) one or more reaction times for a representative population, and, based on this comparison, generate an assessment of a physiological state of the user.

2 . The system of claim 1 , the system further comprising a microcontroller and a light-emitting diode (LED), wherein the stimulus is presented to the user by illuminating the LED, and wherein a stimulus delay between a machine instruction to illuminate the LED and the illumination of the LED is less than a microsecond.

3 . The system of claim 2 , the system further comprising a monotonic clock, the first timestamp is determined by registering a time, on the monotonic clock, that the machine instruction to illuminate the LED is generated, received by the microcontroller, and/or passed to the LED, wherein the wearable device comprises one or more analog-to-digital converters (ADCs) being configured to convert biopotential signals received by the one or more electrodes to a series of biopotential data samples, and each sample of biopotential data has a respective timestamp determined by the same monotonic clock used to generate the first timestamp.

4 . The system of claim 3 , wherein the second timestamp is determined by analyzing the series of biopotential data samples, selecting a set of one or more biopotential data samples, from the series of biopotential data samples, that indicate the intention by the user to perform the responsive action, and determining the second timestamp based on one or more timestamps of the selected set of one or more biopotential samples that indicate the intention by the user to perform the responsive action.

5 . The system of claim 1 , wherein the subject response time determined by the system measures, with an accuracy to within 5 milliseconds, a pre-motor time indicating a time between presentation of the stimulus and peripheral nerve activity responsive to the stimulus.

6 . The system of claim 1 , wherein the assessment of the physiological state of the user relates to one or more of the effects of concussion, intoxication, neurodegenerative disease, mental fatigue, caffeine, adrenaline, sleep deprivation, or circadian rhythms.

7 . The system of claim 1 , wherein the system further comprises a responsive device running a software application, and the system is configured to wirelessly transmit from the wearable device to the responsive device one or more of the assessment of the physiological state of the user, the subject response time, or one or both of the first timestamp and the second timestamp.

8 . The system of claim 7 , wherein the software application is configured to receive a plurality of subject measurements for the user, each subject measurement comprising a respective response time that indicates, with an accuracy to within 5 milliseconds, a respective pre-motor time between presentation of a respective stimulus and respective peripheral nerve activity responsive to the respective stimulus.

9 . The system of claim 8 , wherein the software application is configured to compare the subject response time for the user, or one or more values based thereon, to at least a baseline response time, or one or more values based thereon, for the user that was previously determined by the software application, wherein the comparison is performed by the software application comparing an aggregate measure, determined based on multiple of the plurality of subject measurements for the user, to the baseline response time for the user.

10 . The system of claim 1 , wherein the wearable device is configured to be shared across multiple subjects, the user being among the multiple subjects, wherein the system comprises a software application installed in one or more responsive devices, and the software application is configured to:

receive a human instruction to perform a response time measurement for the user;

cause a software instruction to present the stimulus to the user to be wirelessly transmitted to the wearable device;

receive, from the wearable device, user measurement data, the user measurement data comprising a user premotor time and/or one or more user timestamps; and

associate the user measurement data with a user account for the user and store the user measurement data.

11 . A method for assessing a physiological state of a user based at least in part on biopotentials detected at an external surface of a skin portion of the user, the method comprising:

obtaining, using a plurality of electrodes, biopotential signals generated at least in part by the peripheral nerve tissue;

determining a first timestamp, the first timestamp indicating a first time at which a stimulus is presented to the user;

determining a second timestamp, the second timestamp indicating a second time at which the biopotential signals indicate an intention by the user to perform a responsive action in response to the stimulus;

based at least on the first timestamp and the second timestamp, determining a subject response time for the user; and

comparing the subject response time for the user, or one or more values based thereon, to at least a baseline response time determined based at least in part on (i) one or more prior reaction time tests for the user or (ii) one or more reaction times for a representative population, and, based on this comparison, generating an assessment of a physiological state of the user.

12 . The method of claim 11 , further comprising presenting the stimulus to the user by illuminating a light-emitting diode (LED), wherein a stimulus delay between a machine instruction to illuminate the LED and the illumination of the LED is less than a microsecond.

13 . The method of claim 12 , wherein the first timestamp is determined by registering a time, on a monotonic clock, that the machine instruction to illuminate the LED is generated, received by a microcontroller, and/or passed to the LED, the method further comprising converting the biopotential signals received by the plurality of electrodes to a series of biopotential data samples, and each sample of biopotential data has a respective timestamp determined by the same monotonic clock used to generate the first timestamp.

14 . The method of claim 13 , wherein the second timestamp is determined by analyzing the series of biopotential data samples, selecting a set of one or more biopotential data samples, from the series of biopotential data samples, that indicate the intention by the user to perform the responsive action, and determining the second timestamp based on one or more timestamps of the selected set of one or more biopotential samples that indicate the intention by the user to perform the responsive action.

15 . The method of claim 11 , wherein the determined subject response time measures, with an accuracy to within 5 milliseconds, a pre-motor time indicating a time between presentation of the stimulus and peripheral nerve activity responsive to the stimulus.

16 . The method of claim 11 , wherein the assessment of the physiological state of the user relates to whether the user is one or more of concussed, intoxicated, has a neurodegenerative disease, or mentally fatigued.

17 . The method of claim 11 , further comprising running a software application configured to wirelessly transmit from a wearable device to a responsive device one or more of the assessment of the physiological state of the user, the subject response time, or one or both of the first timestamp and the second timestamp.

18 . The method of claim 17 , wherein the software application is configured to receive a plurality of subject measurements for the user, each subject measurement comprising a respective response time that indicates, with an accuracy to within 5 milliseconds, a respective pre-motor time between presentation of a respective stimulus and respective peripheral nerve activity responsive to the respective stimulus.

19 . The method of claim 18 , wherein the software application is configured to compare the subject response time for the user, or one or more values based thereon, to at least a baseline response time for the user that was previously determined by the software application, wherein the comparison is performed by the software application comparing an aggregate measure, determined based on multiple of the plurality of subject measurements for the user, to the baseline response time for the user.

20 . The method of claim 11 , further comprising:

receiving a human instruction to perform a response time measurement for the user;

causing a software instruction to present the stimulus to the user to be wirelessly transmitted to a wearable device;

receiving, from the wearable device, user measurement data, the user measurement data comprising a user premotor time and/or one or more user timestamps; and

associating the user measurement data with a user account for the user and storing the user measurement data.

Assignments (2)

Continuity (1)

References Cited (400)