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EP-4087465-B1 - WEARABLE NYSTAGMUS DETECTION DEVICES

EP4087465B1EP 4087465 B1EP4087465 B1EP 4087465B1EP-4087465-B1

Inventors

  • RESSMEYER, Ryan Kazuo
  • SANTA MARIA, PETER LUKE
  • KUO, PO HUNG
  • SILVERNAGEL, Michael Paul
  • POON, ADA SHUK YAN
  • STEENERSON, Kristen K.
  • KARGOTICH, Stephen
  • FAN, Danyang
  • DHULDHOYA, Jay

Dates

Publication Date
20260506
Application Date
20210104

Claims (11)

  1. A wearable device, comprising: a unitary substrate comprising a first electrode and a second electrode; and circuitry operably coupled to the first electrode and the second electrode the unitary substrate dimensioned for unilateral placement to only one side of one eye of a user's face to position the first electrode substantially above one eye of the subject and the second electrode substantially to the side of the same eye of the subject, thereby to detect monocular corneo-retinal potentials correlated with horizontal and vertical movement of that single eye, wherein the circuitry is configured to detect horizontal and vertical movements of that single eye of the user from the corneo-retinal potentials detected by the first electrode and the second electrode.
  2. The device according to claim 1, wherein the circuitry comprises an electronic component removably insertable into a compartment on the unitary substrate, and wherein the electronic component when inserted into the compartment is in electronic communication with the circuitry.
  3. The device according to claim 1 or claim 2, wherein the circuitry comprises an analog front end and a digital circuit, preferably with one of the following: • wherein the analog front end comprises a noise filtering circuit and an amplifier circuit; • wherein the digital circuit comprises an analog to digital converter and a microcontroller; • wherein the digital circuit further comprises a digital signal processor.
  4. The device according to any preceding claim, wherein the first electrode is positioned on the substrate such that when placed on a user's face a midpoint of a plane of the first electrode is superior to a transverse (horizontal) plane passing through the center of one of the right eye or the left eye, and the second electrode is positioned on the substrate such that when placed on a user's face a midpoint of a plane of the second electrode is positioned temporally to a sagittal plane passing through a pupil of the eye when looking straight ahead.
  5. The device according to any preceding claim, further comprising a third sensor, wherein the third sensor is configured to sense head position, head movement, and/or head orientation of the user, and wherein the circuitry is operably coupled to the third sensor, preferably wherein the third sensor is an accelerometer, an inertial mass unit, a magnetometer, a gyroscope, or a combination thereof.
  6. The device according to claim 5, wherein the device is configured to continuously monitor eye movement and head position, movement or orientation, or wherein the device is configured to monitor eye movement and head position, movement or orientation in near real time.
  7. The device according to any of claims 5 or 6, further comprising: a storage component operably coupled to the circuitry, wherein the circuitry and the storage component are configured to record eye movement data and head position, movement or orientation data onto the storage component, preferably wherein the storage component is a removable memory card.
  8. The device according to any of claims 5-7, further comprising a transmitter operably coupled to the circuitry, wherein the circuitry and the transmitter are configured to transmit eye movement data, head movement data, head position data, head orientation data, or a combination thereof, preferably wherein the transmitter is a wireless transmitter and wherein the circuitry, and the wireless transmitter are configured to wirelessly transmit eye movement data and data from head movement, position or orientation.
  9. The device according to any preceding claim, with one or more of the following: • further comprising a photosensor configured to sense ambient light, wherein the circuitry is operably coupled to the photosensor and is configured to detect ambient light based on signals from the photosensor; • wherein the circuitry is further configured to detect torsional eye movements; • wherein in addition to the first electrode and a second electrode, the wearable device comprises an electronic component, and the electronic component is on a substrate separate from the unitary substrate on which the first electrode and second electrode are affixed; • wherein the circuitry comprises an electronic component on a substrate separate from the unitary substrate, and the circuitry is operably coupled to the first electrode and the second electrode.
  10. A system for detecting eye movements of a subject, comprising: a wearable device according to any one of the preceding claims and a software application comprising an algorithm for processing data received from the wearable device.
  11. The system of claim 10 with one or more of the following: • wherein the software application is downloadable to a mobile device, preferably • wherein the mobile device comprises a processor operably connected to a memory for storage of the algorithm, wherein the algorithm is configured to process the data to (i) distinguish between horizontal, vertical and torsional eye movements or (ii) recognize one or more specific patterns of eye movement, more preferably • wherein the algorithm process the data to recognize one or more specific patterns of eye movement corresponding to neutral gaze, leftward gaze, rightward gaze, upward gaze, downward gaze or a nystagmus event; • wherein the system is configured to recognize characteristic eye movements of nystagmus events associated with benign paroxysmal positioning vertigo, Meniere's disease or vestibular neuritis.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62/957,563, filed January 6, 2020. TECHNICAL FIELD The subject matter described herein relates to wearable device with sensors to detect or derive corneo-retinal potential signals related to eye movement of a subject and circuitry operably coupled to the sensors. BACKGROUND Nystagmus refers to characteristic eye movements that may arise in patients when they experience attacks of dizziness originating from underlying vestibular or neurological conditions. Such characteristic eye movements, nystagmus events, result from the neural connections between the inner ear and the eye, i.e., the vestibular ocular reflex, and generally do not occur when a patient is not experiencing dizziness. Nystagmus events can be characterized based on the nature of the eye movements exhibited by patients. Differentiating the types of eye movements may facilitate diagnosis of a patients' underlying vestibular or neurological conditions. For example, patients with benign paroxysmal positional vertigo tend to exhibit triggered nystagmus typically lasting less than about sixty seconds in at least three distinct directional patterns. Patients with Meniere's disease tend to exhibit unidirectional horizontally beating nystagmus lasting twenty minutes to twelve hours with then reversal of direction following the attack. Patients with vestibular migraines tend to exhibit combinations of vertical and horizontal nystagmus lasting up to several hours to days. Thus, even though patients with these different conditions may all express the common complaints of an attack of dizziness, examining the nature of nystagmus events may facilitate diagnosing the underlying vestibular or neurological conditions. Accurate diagnosis of these conditions is important, in part, because of the dramatic range of treatments for each condition, from a repositioning maneuver for benign paroxysmal positional vertigo, to trans-tympanic injections or surgery for Meniere's disease, to oral medications for vestibular migraines. Traditionally, patients would have to visit a doctor's office or other clinical setting for detection of the different nystagmus events and diagnosis of the associated, underlying conditions. Currently, a common technique for doing so in a clinic is video nystagmography (VNG). VNG entails a patient wearing head-mounted goggles with infrared cameras that image and record eye movements of the patient during about two hours of testing in the clinic. Unfortunately, the diagnostic accuracy of VNG is generally poor since patients are not necessarily likely to experience a dizziness attack while undergoing testing in the clinic. Other limitations of VNG include unrepresentative and sub-physiologic measurements of vestibular function, delayed as well as limited accessing of VNG testing due to the need for bulky, stationary equipment and highly skilled technologists or audiologists, a high cost to insurance companies, limitations due to directly imaging and recording eye movements such as being unable to perform measurements when the eyes are closed, sensing artifacts from blinking, eye makeup or a structurally obtrusive eyelid architecture. EP 338 623 Al discloses determining eye movement using piezo-electric sensors. Thus, an alternative technique for monitoring eye movements so as to detect nystagmus events in patients has the potential to improve diagnoses and patient treatment as well as to reduce associated costs. The devices, systems, methods and kits described herein provide such techniques. BRIEF SUMMARY The invention is defined by a device according to claim 1. Further embodiments are defined by dependent claims 2-11. In one embodiment, the circuitry comprises an analog front end and a digital circuit. In one embodiment, the analog front end comprises a noise filtering circuit and an amplifier circuit. In one embodiment, the digital circuit comprises an analog-to-digital converter and a microcontroller. In one embodiment, the digital circuit further comprises a digital signal processor. In one embodiment, the first and second sensors are configured to measure a difference in electrical potential between a cornea and a retina of the subject. In one embodiment, the first and second sensors are configured to measure electrical activity of muscles. In one embodiment, the first and second sensors are configured to measure the electrical activity of extraocular and facial muscles. In one embodiment, the one or more first electrodes are positioned at one or more first locations and the one or more second electrodes are positioned at one or more second locations, wherein the one or more first and second locations are proximal to one eye of the subject. In one embodiment, the one or more first electrodes and the one or more second electrodes are positioned asymmetrically with respect to horizontal and vertical axes that intersect a pupil. In o