WO2021014445A1 - Dispositif de mesure électrophysiologique porté à la main - Google Patents

Dispositif de mesure électrophysiologique porté à la main Download PDF

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Publication number
WO2021014445A1
WO2021014445A1 PCT/IL2020/050814 IL2020050814W WO2021014445A1 WO 2021014445 A1 WO2021014445 A1 WO 2021014445A1 IL 2020050814 W IL2020050814 W IL 2020050814W WO 2021014445 A1 WO2021014445 A1 WO 2021014445A1
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WIPO (PCT)
Prior art keywords
patient
electrodes
hand
recording
user
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PCT/IL2020/050814
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English (en)
Inventor
Sergiu ABRAMOVICI
Original Assignee
Ichilov Tech Ltd.
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Publication of WO2021014445A1 publication Critical patent/WO2021014445A1/fr

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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
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    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
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Definitions

  • the present invention in some embodiments thereof, relates to a hand-worn device for acquiring and/or monitoring patient data, and, more particularly, but not exclusively, to a hand- worn device and interface configured for obtaining and processing electrophysiological data, such as EEG.
  • a measuring system for measuring electrocardiogram signals comprises a diagnostic garment with ECG electrodes that may assume the form of a sleeve or glove.
  • a disposable version of the glove can be inflated.
  • the contour of the body is automatically matched by the contour of the glove.
  • Samples from the ECG electrodes positioned on a diagnostic garment are compensated so that the samples better approximate samples from EEG electrodes that are positioned at classical locations.
  • a system (10) for collecting a plurality of diagnostic information and transmitting the diagnostic information to a remote location comprises a glove member (12) adaptable to be worn on a person's hand and an interface unit (20) in electrical communication with the glove member (12).
  • the interface unit (20) is capable of transmitting information to, and receiving information from, a remote location.
  • the glove member (12) comprises a palm portion (1), a wrist portion (3) and five phalange portions (5-13).
  • the glove member (12) further comprises an EKG diagnostic device, a blood pressure and pulse rate diagnostic device (54) and a temperature device (64).
  • the glove member (12) may also further comprise a % 02 diagnostic device (70) and an auscultation device (80).” (Abstract)
  • a hand- worn device for EEG recording from a patient comprising: at least two sheaths, each sheath shaped and sized for fitting a user’s finger, each sheath including an electrode mounted onto an external surface of the sheath; and circuitry configured to acquire and process EEG signals recorded from a patient by the electrodes and for communicating the recorded EEG signals to a remote device.
  • the at least two sheaths comprise or are made of an electrically insulating material.
  • each of the sheaths comprises an electrically insulating lining covering an internal side of the sheath.
  • the device is formed as a glove shaped and sized for fitting a user’s hand.
  • the glove comprises: at least three sheaths; at least three electrodes, each electrode mounted onto one of the sheaths; and the circuitry includes an analog to digital converter, an amplifier, and a communication module.
  • the circuitry is housed within a cuff portion of the glove.
  • the electrodes are dry electrodes, each electrode comprising a plurality of pins long enough for contacting the patient’s scalp through hair.
  • the pins protrude at least 2 mm away from the external surface of the sheath.
  • the circuitry comprises a controller programmed to control recording by the electrodes based on input received from the remote device.
  • each of the sheaths comprises at least one spring positioned between the electrode and the external surface of the sheath which provides resistance in response to pressure applied onto the electrode.
  • the device comprises one or more optical markers positioned on the external surface, the optical markers detectable by the remote device.
  • a system comprising: a device for example as referred to herein, and a remote device including a user interface, the user interface configured for receiving input data and for generating a patient condition related indication based on the input data and on the EEG signals recorded by the electrodes.
  • the circuitry is programmed to communicate with the remote device and the remote device is programmed to control recording by the electrodes.
  • the input data includes a current position of the electrodes with respect to the patient’s head. In some embodiments, the input data includes one or more of: vital signs, symptoms exhibited by the patient; an assumed medical condition, an associated event which the patient was involved in, and the patient’s medical and surgical history.
  • the user interface comprises a screen for presenting operating instructions to a user relating to the position of the electrodes with respect to the patient’s head.
  • the remote device comprises a smart phone or a tablet computer.
  • the remote device comprises: an imager; and circuitry configured to identify a position of the electrodes with respect to the patient’s anatomy from images acquired by the imager.
  • the user interface is configured as augmented reality glasses to be worn by a user.
  • the glasses are configured to present to a user one or more of: instructions for positioning the hand-worn device on the patient; a duration for measuring; currently recorded data; patient condition related indications.
  • one or both of the hand worn device and the remote device are configured to transfer and/or receive data to and/or from a medical center database.
  • the data includes the patient condition related indication generated by the system.
  • the data includes follow-up instructions generated based on the patient related condition indication.
  • follow up instructions include recommendations for imaging the patient and/or for the type of imaging modality required and/or the anatomical region deemed relevant for imaging.
  • the remote device is configured for generating the patient related condition indication within 3-6 minutes of recording the EEG signals.
  • kits comprising: a set of two hand-worn devices for example as described herein, wherein at least one of the devices further comprises a stimulation module for applying an electrical, visual and/or audible stimulation to the patient.
  • a method for recording EEG of a patient using a hand-wom device comprising a plurality of EEG electrodes, comprising: wearing the hand- worn device on at least a portion of a user’s hand; contacting the plurality of EEG electrodes with the patient’s scalp by separately placing a plurality of user’s fingers on the patient’s head; and recording EEG signals.
  • the method comprises obtaining an automatically generated indication related to a condition of the patient, the indication at least partially based on the recorded EEG signals.
  • recording is for a time period of between 5-30 seconds for each recording position or epoch.
  • the method comprises adjusting a position of the user’s hand relative to the patient’s head to reposition at least some of the plurality of electrodes on the scalp.
  • the hand- worn device comprises or is in communication with a user interface and the placing and/or the adjusting are according to instructions provided by the user interface.
  • recording comprises setting the electrodes in a bipolar montage or in a weighted average montage.
  • one of the plurality of electrodes is used as a reference and ground and in the weighted average montage one of the plurality of electrodes is used as common average.
  • the method comprises repeating the placing and recording steps at a plurality of different positions relative to the patient’s scalp.
  • the indication related to a condition of the patient is generated by determining patterns in the recorded EEG signals using feature extraction techniques and comparing the patterns to pre-established EEG patterns known to be associated with physiological and/or pathophysiological conditions.
  • the indication related to a condition of the patient is from the group of: a stroke, a head or spinal tumor, encephalitis, head trauma, epilepsy, encephalopathy, headache, back pain, spinal cord pathology, multiple sclerosis, other myelopathy, limb weakness/numbness, visual disturbance, unilateral hearing loss.
  • a method for stimulating a patient and detecting a response to the stimulation using a hand-worn device comprising a plurality of electrodes comprising: applying an electrical stimulation to an affected limb; and using the hand-worn device, recording a response to the stimulation via the plurality of electrodes.
  • the electrodes comprise EEG electrodes.
  • the response comprises an evoked potential of the nervous system.
  • applying is via a stimulating device comprising at least an anode, cathode and grounding elements.
  • recording comprises positioning the hand-worn device on the patient’s head such that the electrodes are in contact with the scalp.
  • recording comprises positioning the hand-worn device on any anatomical area such that the electrodes contact the skin.
  • an electrical stimulation is applied to a patient’s upper limb and/or lower limb.
  • recording is performed at one or more locations along a neural path leading to the stimulated anatomical area.
  • a hand- worn device for recording of electrophysiological data from a patient, comprising: at least three sheaths shaped and sized for fitting a user’s fingers; at least three electrodes, each electrode mounted on an external side of each of the sheaths; and circuitry for activating the electrodes to record electrophysiology related signals from a patient and for communicating the recorded signals to a remote device.
  • the electrophysiology data comprises at least one of: Electroencephalography (EEG), Electrocardiogram (ECG) data; Nerve Conduction Velocity (NCV) data; Visual Evoked Potentials (VEP); Brainstem Auditory Evoked Potentials (BAEP); Somatosensory Evoked Potentials (SSEP).
  • a hand- worn device for EEG recording of a patient comprising: at least two sheaths, each sheath shaped and sized for fitting a user’s finger, each sheath including an electrode mounted onto an external side of the sheath, the electrode shaped for contacting the patient’s scalp for recording EEG signals; and circuitry configured to acquire and process signals recorded from a patient by the electrodes and for communicating the recorded signals to a remote device.
  • Implementation of the method and/or system of embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof using an operating system.
  • a data processor such as a computing platform for executing a plurality of instructions.
  • the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data.
  • a network connection is provided as well.
  • a display and/or a user input device such as a keyboard or mouse are optionally provided as well.
  • FIG. 1A is a flowchart of a general method for recording EEG signals using a hand-worn device, according to some embodiments
  • FIG. IB is a diagram of a basic system for recording EEG signals using a hand-worn device, according to some embodiments.
  • FIG. 1C schematically illustrates positioning a hand-wom device on a patient’s head, according to some embodiments
  • FIG. 2 schematically illustrates a hand-wom device in the form of a glove for recording EEG signals, according to some embodiments
  • FIG. 3 illustrates a multi-modality hand- worn device, according to some embodiments
  • FIGs. 4A-F schematically illustrate examples of positions of a hand worn device comprising electrodes on a patient’s head, according to some embodiments;
  • FIG. 5 describes EEG measuring schemes of electrodes mounted on a hand-worn device, according to some embodiments;
  • FIG. 6 is a flowchart of a method of generating a patient condition indication based on data acquired by a hand- worn device, according to some embodiments
  • FIG. 7 is a flow diagram of an exemplary method for processing data acquired by a hand- worn device, according to some embodiments.
  • FIGs. 8A-G are examples of user interface screens of a hand- worn device, according to some embodiments.
  • FIG. 9 is a flow diagram of an exemplary method of using optical means for assisting in positioning of a hand- worn device on a patient, according to some embodiments.
  • FIG. 10 illustrates an example of using optical means in the form of augmented reality glasses for assisting in positioning of a hand-wom device on a patient, according to some embodiments
  • FIG. 11 is a flowchart of a method of using a hand-worn device for stimulating a patient’s body part and/or for detecting a response to the stimulation, according to some embodiments;
  • FIG. 12 illustrates applying stimulation to a patient and detecting a response to the stimulation using at least one hand-wom device, according to some embodiments
  • FIG. 13 illustrates exemplary anatomical positions for stimulating and detecting a response to the stimulation using at least one hand-worn device, according to some embodiments
  • FIGs. 14A-B schematically illustrate applying a renewable conductive gel onto a hand- wom device (FIG. 14A) and a magazine of finger-tip electrodes (FIG. 14B), according to some embodiments;
  • FIGs. 15A-B schematically illustrate a mechanism for providing haptic feedback to a user of a hand worn device, according to some embodiments
  • FIG. 16 schematically illustrates applying a visual stimulation to a patient and detecting a response to the stimulation using a hand worn device, according to some embodiments
  • FIG. 17 is a photo of a prototype of a hand worn device for recording EEG signals, according to some embodiments.
  • FIG. 18 shows various modalities for use in a hand-wom device, according to some embodiments. DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION
  • the present invention in some embodiments thereof, relates to a hand-worn device for monitoring patient data, and, more particularly, but not exclusively, to a hand-wom device and interface configured for obtaining and processing electrophysiological data, such as EEG data.
  • a broad aspect of some embodiments relates to recording data from a patient by placing a hand-wom device comprising a plurality of electrodes on an anatomical area of the patient.
  • electrodes are placed at a selected spatial arrangement, and signals are recorded over a relatively short period of time ranging, for example, between 10-60 seconds.
  • recording is performed from a plurality of different spatial arrangements, and the user wearing the hand-wom device adjusts the electrode positions by moving their hand or only the fingers relative to the patient’s body.
  • positioning of electrodes is by placing the user’s fingers on the patient’s head, optionally by placing each finger separately to thereby place an associated electrode in contact with the patient’s head.
  • a potential advantage of moving the hand or fingers to quickly place an electrode or adjust an electrode position may include utilizing a natural dexterity of the hand, thereby potentially providing for rapid and accurate placing of each of the electrodes at a desired position, and/or for faster switching between positions.
  • rapid collecting of data from the patient is enabled due to that no or only little setup is required, allowing the user to immediately place the hand-worn device and initiate recording, optionally adjusting the electrode position in real time.
  • hand-wom devices and methods of use for example as described herein may be especially advantageous in emergency situations, pre-hospital settings, and/or other locations or situations in which a simple, dynamic assessment of the patient condition is required.
  • an aspect of some embodiments relates to a hand- worn device suitable for acquiring and monitoring EEG of a patient.
  • the hand-wom device is in the form of a glove.
  • a user wearing the device places it on the patient’s head such that the electrodes are in operable contact with the scalp.
  • various device positions e.g. electrode positions
  • for recording during a plurality of epochs are selected based on the clinical context (symptoms exhibited by the patient, an event the patient was involved in [e.g. car accident], a known premorbid condition, etc.).
  • the device is used in a scanning mode, in which the user places the hand-worn device at various spatial positions until detecting abnormal findings (for example, certain EEG patterns) which may be indicative of the patient’s condition.
  • the device comprises 5 electrodes, each electrode located with respect to a user’s finger. Using the 5 electrodes, 8 different recording channels may be obtained. The user may position the 5 electrodes at various arrangements with respect to each other to obtain a selected recording montage, such as a longitudinal (sagittal) or transverse (coronal) bipolar recording montages, or a weighted average recording montage.
  • An aspect of some embodiments relates to interacting with a user of a hand-wom device, for example to instruct the user regarding device positioning.
  • the hand- wom device communicates with a remote device, transferring the recorded data to the remote device and/or receiving input data from the remote device.
  • the remote device comprises a user interface, optionally including a screen for displaying information to the user and/or for receiving input from the user.
  • a user interface may be configured for example on a cellular phone, a tablet computer, a smart watch and/or other optionally portable device.
  • the user interface is configured as augmented reality glasses.
  • the user wears the glasses whilst placing the hand- worn device on the patient’s body.
  • the user interface is programmed to provide the user guidance and/or feedback regarding a position of the electrodes, a duration of recording, an anatomical region to record from.
  • the user interface comprises imaging means (such as a camera) and circuitry configured to assess current electrode positions based on images acquired by the camera.
  • the hand-wom device comprises position indicators (e.g optical markers, position sensors, etc.) detectable by the system.
  • the hand-wom device is constructed to provide haptic feedback to the user, for example to direct electrode positioning, to indicate that recording was initiated, to indicate poor contact with the skin, to indicate potential existence of a pathology or irregularity, and/or other indications.
  • the hand-wom device comprises a vibrating mechanism, such as a spring based vibrating mechanism, which sets vibrations to thereby provide sensory feedback to the user wearing the device.
  • the user interface is configured for processing of signals recorded from a patient, optionally in real time.
  • processing of the signals is carried out by detecting patterns in the recorded data (for example using feature extraction techniques), and comparing the patterns to pre-established patterns, such as patterns known from literature, patterns previously recorded from the same patient, patterns associated with a population, patterns associated with a certain physiological and/or pathophysiological state, optionally compared to a similar state in a large cohort (which may be considered as a normal baseline). Based on the detected patterns, an indication related to the patient condition is generated. Optionally, a differential diagnosis is generated and displayed to the user. Examples of conditions which may be detected and/or assessed by devices and systems for example as described may include: encephalopathy (e.g.
  • An aspect of some embodiments relates to detecting and optionally recording an evoked potential in response to stimulation using at least one hand-worn device comprising a plurality of electrodes.
  • a stimulation is applied to a patient (e.g. an electrical stimulation; a visual stimulation; an audible stimulation) and a neural response to the stimulation is detected by the hand- worn device (i.e. evoked potentials).
  • electrical stimulation is applied to a limb, and the hand-worn device is placed on the patient’s scalp to record a somatosensory evoked potential (SSEP).
  • SSEP somatosensory evoked potential
  • visual stimulation is applied using a light source (Visual Evoked Potential-VEP).
  • audible stimulation is applied via headphones or the like (for Brainstem Auditory Evoked Potentials-BAEP). Stimulating and measuring may be carried out via a pair of hand worn devices (e.g. using one device to apply the stimulation, and the other to measure the response) or alternatively using any stimulating device (e.g. sleeve, clip comprising suitable circuitry) and a hand-worn device to measure the response.
  • stimulation is applied to a distal limb portion, and recording is performed from a plurality of positions along the ascending neuro-axis.
  • the glove is positioned at a plurality of locations along the neural path (e.g. the peripheral nerve, portions of the plexus, spinal cord, scalp).
  • a location of transmission interruption is detected, indicating a possible pathology.
  • detection of evoked potentials may provide for identifying a pathological source or condition.
  • FIG. 1A is a flowchart of a general method for recording EEG signals using a hand-wom device, according to some embodiments.
  • a method for example as described herein is implemented for diagnosing (or otherwise contributing to diagnosis) of a patient during emergency situations, when a fast, dynamic assessment of the patient condition is advantageous.
  • a method for example as described herein may be carried out in a non-hospital setting (such as for emergency medicine providers, military medicine, ambulance, rural clinics and the like), or, alternatively, in a clinical setting, such as in an emergency room, physician clinic and/or generally at any situation in which a rapid and simple assessment of the patient condition is advantageous, for example in assisting diagnostic and/or therapeutic decision making.
  • a method for example as described herein is implemented during non-emergency situations, for example, as a protocol for standard assessment and screening of a patient for predetermined conditions, such as at a family practice clinic.
  • a method as described herein may be especially advantageous for identifying conditions related, for example, but not limited to: diffuse or focal encephalopathy (of any etiology- such as, but not limited to: ischemic stroke, brain hemorrhage, brain tumor); status epilepticus, seizures, interictal epileptiform discharges; assisting in ruling out electrophysiological changes in cases of structural brain injury, headaches; assessing for electrophysiological disturbance in cases of focal weakness or numbness, altered mental status, back pain, spinal cord pathology (tumors, abscess, myelopathy of other causes such as multiple sclerosis), visual disturbance (either of central origin via occipital EEG, or pre-cortical - via VEP), focal hearing loss, toxic or metabolic encephalopathy, assessment after anoxic brain injury (such as in, but not limited to: drowning, prolonged resuscitation), neurodegenerative disease (periodic patterns, P300 latency) and/or other conditions.
  • diffuse or focal encephalopathy of
  • a user e.g. physician, nurse, physician assistant, paramedic, emergency medical technician (EMT), other care giver or in some embodiments, the patient themselves wears the hand-wom device on their hand.
  • the device is in the form of a glove, and the user inserts their hand into the glove.
  • the device comprises a plurality of EEG electrodes positioned such that upon placing of the device on the patient’s head, the electrodes come into operable contact with the scalp.
  • the user places their hand on the patient’s head, ensuring that at least some of the electrodes operably contact the scalp.
  • contact is made through patient’s hair, for example by the device including electrodes having pins, spikes or other suitable design for passing through hair to contact the scalp.
  • the user adjusts a position of one or more of the electrodes relative to the scalp, for example by moving one or more fingers and/or by moving their hand as a single unit relative to the patient’s head.
  • setting and/or adjusting a device position is according to guidance, for example automatic guidance provided to the user by a user interface of the hand-worn device, such as via a dedicated cellular phone or tablet application.
  • guidance provided to the user includes instructions for spatially positioning the electrodes, a minimal duration for recording EEG at each position, and/or requests for input (such as personal patient data and/or data relating to a current condition or symptom and/or relevant past medical and/or surgical history) from the user.
  • the user interface is programmed to provide guidance in accordance with input data inserted by the user, for example, the user inserts an estimation of a medical condition, a list of symptoms exhibited by the patient, and/or other input data, and guidance (e.g. regarding device positioning) is selected according to the input data.
  • a scanning mode is implemented, for example in which no pre-assumed condition is inputted, and the user places the device at multiple different spatial scalp positions while scanning for potential electrophysiological changes (such as EEG patterns) which may be indicative of the patient’s condition.
  • an experienced and/or expert user e.g. neurologist
  • EEG signals are recorded for a time period of, for example, between 5-30 seconds, such as 10 seconds, 20 seconds, 25 seconds or intermediate, longer or shorter time periods.
  • the duration is influenced by the quality of the acquired data.
  • calibration of the device is performed, for example to set operation settings according to the current electrode positions. In some cases, device calibration may add between 2-6 seconds to each recording session.
  • the recorded data is transferred to a device memory or database.
  • the recorded data is communicated, optionally in real time, to a medical center, a physician’s clinic, cloud memory, and the like.
  • steps 103-107 are repeated.
  • the user adjusts a position of the hand with respect to the patient’s head, so as to position at least some of the electrodes at different spatial locations relative to the previous spatial locations recorded from.
  • the user skims through several (e.g. 2, 3, 4, 5, 10 or intermediate, larger or smaller number) different spatial positions.
  • a patient condition-related indication is generated.
  • the condition-related indication is generated by processing the EEG or other electrodiagnostic data collected over the plurality of recording sessions.
  • the condition-related indication is generated in accordance with other input data, including, for example: personal patient information (e.g. age, weight, height, past medical and/or surgical history); symptoms exhibited by the patient; events associated with a current patient condition (e.g. the patient was involved in car accident, the patient fainted); an assumed medical diagnosis; vital signs such as body temperature, heart rate, blood pressures, respiration rate and/or other data.
  • the vital signs assist in determining a patient’s condition, for example, slow heart rate and high blood pressure may support existence of increased intracranial pressure; low blood pressure with a high fever may indicate sepsis; etc.
  • processing of the collected EEG data is carried out using pattern recognition techniques.
  • patterns identified in the collected data e.g. using feature extraction techniques
  • pre-established patterns e.g. patterns pertaining to the same patient, normal physiological and pathophysiological patterns as collected in large cohort population, literature-based patterns, and/or other
  • the user determines how to continue treating the patient.
  • the decision is made in accordance with the generated differential diagnosis.
  • the user interface automatically suggests a plan for continuing investigation and/or treatment.
  • the user continues treating the patient; additionally, or alternatively, the patient is transferred to a medical center and/or to other medical personnel to receive additional treatment.
  • the follow-up treatment plan includes imaging the patient, for example via CT/MRI, while indications obtained by the hand- worn device may assist is determining a specific anatomical region to be imaged (thereby potentially saving time, money, and/or discomfort to the patient).
  • FIG. IB is a diagram of a basic system for recording EEG signals using a hand-wom device, according to some embodiments.
  • system 131 comprises a hand-wom device 133, including a plurality of electrodes 135, for example 2, 3, 4, 5, 10 electrodes or intermediate, larger or smaller amount.
  • the electrodes are EEG electrodes.
  • device 133 is designed to fit on at least a portion of a user’s hand, for example, being formed as a glove.
  • the device comprises any wearable arrangement which is suitable for positioning electrodes 135 relative to the user’s hand so that the user is able to move the electrodes by moving their fingers.
  • electrodes may be mounted on a set of sheaths which fit on the user’s fingers.
  • electrodes include an adhesive material, and are used as stickers that the user can attach onto their bear hand or onto a glove, e.g. a disposable glove, a netting, and/or other.
  • electrodes 135 are positioned facing the anterior (palmar) side of the hand. In some embodiments, electrodes 135 are positioned at a tip of each of the fingers. In an example, 5 electrodes are distributed at the tips of the 5 fingers. Having the electrodes arranged on device 133 such that the electrodes are mounted with respect to an anterior (palmar) side of the user’s hand when the device is worn by the user provides for controlling a position of the electrodes utilizing a dexterity of the fingers.
  • the user adjusts electrode position by moving their hand as a whole and/or moving one or more fingers.
  • the user adjusts electrode contact with the patient’s scalp, for example by pressing down on and/or slightly lifting up one or more selected electrodes relative to the patient’s scalp and/or adjusting the contact angle.
  • electrodes 133 are connected via circuitry 137 suitable for electrically activating the electrodes, such as by connecting the electrodes to a power source 139 (e.g. a battery, for example a 5V battery).
  • a power source 139 e.g. a battery, for example a 5V battery.
  • circuitry 137 is configured as thin wiring, optionally embedded within the glove material.
  • the power source is integrated in the hand worn device.
  • the power source is positioned separate from the device, optionally powering it remotely (via wired and/or wireless communication).
  • device 133 comprises circuitry for digitizing the recorded signals, for example an analog to digital converter 142.
  • passive and/or active electrodes may be used, affecting the powering requirements.
  • device 133 (optionally via circuitry 137) is connected to or comprises a controller 140. Additionally or alternatively, control of the hand worn device is via a computational unit of a personal electronic device such as a designated device, a cell phone or a tablet. Functions as described herein with respect to the controller may be carried out by the computational unit, in replacement and/or addition to the device controller.
  • controller 140 controls activation of electrodes 133.
  • controller 140 comprises a processor 141 programmed to analyze the recorded data (i.e. EEG or other).
  • the processor is programmed to apply various algorithms on the collected data, for example, to carry out deep neural network analysis of the data.
  • controller 140 is in communication with a database 143.
  • recorded data is communicated to the database and stored there.
  • database stores pre-established patterns which the recorded data is compared to.
  • database 143 stores protocols for device activation, for example including timing of recording sessions and/or electrode positioning information.
  • database stores recorded data of a plurality of patients.
  • the recorded data is linked to a patient condition, medical indication and/or differential diagnosis.
  • system 131 comprises a user interface 145.
  • user interface 145 is configured on a personal device, optionally a hand-held device, such as cellular phone or tablet, a personal watch (e.g. smart watch), and/or other wearable or other in-network environmental computing system.
  • user interface 145 comprises a display 147.
  • the interface (for example via a screen display, such as a touch screen display) is configured for receiving input from the user (e.g. patient personal information, symptoms, vital signs, related event and/or other).
  • display presents visual feedback to the user, for example guidance for positioning electrodes, a graphical analysis of recorded signals, proposed diagnosis, proposed plan for continuing treatment, and/or other data.
  • user interface 145 provides audible feedback (e.g. voice instructions to the user).
  • user interface 145 provides tactile feedback to the user, for example, the device (e.g. cell phone) vibrates when an electrode is properly placed.
  • circuitry including, for example, signal amplifier, converter, communication components and/or other components
  • circuitry is separable or provided separately from the device (e.g. glove) itself.
  • circuitry is configured at the user interface and/or other remote device.
  • the user interface is configured to receive input from the user in the form of manual commands (e. g. by pressing a button); voice commands; text commands and/or other.
  • FIG. 1C schematically illustrates positioning a hand- worn device on a patient’s head, according to some embodiments.
  • recording of data such as of EEG signals is performed when a user places their hand 161 (while wearing the device) on the patient’s head 163.
  • the device electrodes 165 e.g. at least 2 electrodes
  • all device electrodes e.g. 5 electrodes
  • one or more other electrodes do not come in contact with the scalp.
  • recording is performed from a plurality of different spatial scalp locations. All scalp regions may be evaluated using the hand-worn device: frontal, temporal, central, parietal, occipital.
  • recording positions are selected based on the suspected and/or detected condition and/or on the type of measurement performed. For example, in the case of assessing limb weakness by measuring evoked potentials, electrode positions Fz- Ci/Cc may be used. In the case of assessing visual evoked potentials, electrode positions 01/02- Cz/Pz may be used. In the case of assessing brainstem auditory evoked potential, electrode positions M1/M2 may be used, and/or other suitable positions. In some embodiments, electrodes are positioned over the spine, plexus locations and/or large peripheral nerve locations.
  • Exemplary electrode positions may include a position in which the user’s fingers are clustered together, locating the plurality of electrodes in proximity to each other (e.g. to measure from a single specific scalp region); alternatively, the user’s fingers are spread apart, optionally positioning the electrodes at relative distances from each other.
  • FIG. 2 schematically illustrates a hand-wom device in the form of a glove for recording EEG signals, according to some embodiments.
  • glove 201 comprises a covering for the hand, made of a flexible material, suitable to fit different size hands.
  • glove 201 comprises an inner insulating layer (not shown), for example an electrically and/or thermally insulating layering, and an outer layer onto which the electrodes are mounted.
  • a potential advantage of an insulating layer may include reducing or preventing noise such as due to user related artifacts (i.e. self bioelectricity interference).
  • the glove comprises a fluid-resistant exterior layer (e.g. a dense synthetic fiber layer, optionally with a hydrophobic coating).
  • a fluid-resistant exterior layer e.g. a dense synthetic fiber layer, optionally with a hydrophobic coating.
  • an outer insulating later is provided.
  • glove 201 includes sheaths 202 for the fingers.
  • electrodes 203 are mounted or embedded at the tip of each sheath, for example, one electrode on each of five sheaths.
  • the other electrodes may be referred to as F1-F4.
  • the electrode settings may vary from use to use, for example changed according to instructions sent by the controller.
  • electrodes are used according to the following examples of montages: a bipolar montage - measuring potential between F1-F2, F2- F3, F3-F4, with the thumb electrode serving as grounding/reference electrode.
  • a Laplacian channel is calculated, by measuring potential differences between the thumb electrode, and the average of the finger electrodes (Fl- F4), optionally positioned to surround the thumb electrode.
  • the different montages are obtained by applying a computational manipulation to the recorded data.
  • electrodes 203 comprise dry electrodes, optionally each including a plurality of protruding pins 207.
  • pins 207 are long enough to contact the patient’s scalp through a layer of hair.
  • electrodes 203 are wet electrodes.
  • a conductive paste or high viscosity gel are applied to the scalp and/or to the wet electrodes to ensure electrical conductivity.
  • glove 201 comprises an electrical stimulator 205 suitable for generation of somatosensory evoked potentials to be recorded, for example, by a second glove.
  • an external stimulator is provided (optionally as a second glove (205) and/or a stimulating sleeve), including at least an anode, cathode and grounding element.
  • Applying of an electrical stimulation and/or other stimulation may be activated via the user interface (e.g. via a touch screen or buttons), and/or optionally via a voice command.
  • glove 201 comprises a control region, in this example shown at the cuff 209 of the glove.
  • the control region includes one or more of: a power source (e.g batteries); circuitry for electrode activation (for example a controller); an amplifier; an analog to digital converter; circuitry for communicating data to and/or from one or more: a user interface (e.g. a cell phone application, a computer); a remote server or database (e.g. cloud database); one or more additional gloves; one or more additional devices such as virtual reality glasses used with the glove; and/or other components or circuitry.
  • a power source e.g batteries
  • circuitry for electrode activation for example a controller
  • an amplifier for example a controller
  • an analog to digital converter circuitry for communicating data to and/or from one or more: a user interface (e.g. a cell phone application, a computer); a remote server or database (e.g. cloud database); one or more additional gloves; one or more additional devices such as virtual reality glasses used with the glove; and/
  • glove 201 comprises one or more mechanisms which provide feedback to the user.
  • haptic feedback is provided, for example using a spring-based mechanism attached at the electrode position.
  • the spring-based mechanism generates vibrations sensed by the finger of the user when an electrode is accurately positioned and is recording or instead when an electrode needs to be moved to improve position and/or contact.
  • tactile feedback is provided to indicate certain findings.
  • the feedback comprises counter pressure sensed by the user.
  • pre-defined vibration sequences are generated in response to detection of certain findings.
  • diverse findings e.g. signal patterns
  • feedback is provided as visual feedback (e.g. light, such as LED) indications on the glove which may assist in positioning.
  • glove 201 comprises one or more markers 211, for example optical markers, which may be used for indicating position.
  • each marker indicates a position of an individual fingertip with respect to the patient’s body.
  • the system identifies the marker positions and locates them with respect to the patient body.
  • image recognition techniques are applied to identify distinct feature.
  • an imager e.g. a camera
  • personal electronic device e.g. cell phone, tablet or designated device
  • designated augmented reality glasses captures an image or a video, and the markers are detected in that image or video.
  • an image of the electrode positions with respect to the patient’s body is projected to the user, for example via a user interface screen and/or on the designated augmented reality glasses.
  • the markers are represented by white dots.
  • glove 201 comprises one or more position sensors 213.
  • the position sensors are integrated within the material of the glove.
  • the device controller and/or user interface receive position related indications from the one or more sensors.
  • FIG. 3 illustrates a multi-modality hand-worn device, according to some embodiments.
  • a multi-modal hand-worn device (e.g. in the form of a glove) includes various sensing and/or stimulating components.
  • a glove 301 comprises one or more of:
  • the system is configured to receive input regarding and/or is configured to automatically recognize (e.g. by identifying an electrode position) which data type the user is interested in measuring and deploys the suitable scale and/or processing algorithms.
  • the electrodes“passively” record EEG data from the scalp.
  • a stimulation is applied in parallel to generate an evoked potential, to be recorded by the electrodes.
  • the system recognizes (e.g. via image processing techniques) and/or receives input regarding the applying of a stimulation, and settings are adjusted accordingly.
  • the epochs may be recorded for a duration of between 60-360 milliseconds (for example: 60 ms for SSEP (which may be suitable for detecting N20 / P37 potentials); 150ms for VEP (which may be suitable for detecting PI 00, a sensory- specific ERP component); 360ms for P300; less then 60ms for BAEP).
  • 60 ms for SSEP which may be suitable for detecting N20 / P37 potentials
  • 150ms for VEP which may be suitable for detecting PI 00, a sensory- specific ERP component
  • 360ms for P300 less then 60ms for BAEP.
  • the system is configured to measure a distance between a stimulating electrode and a recording electrode.
  • the distance is measured via image processing techniques.
  • a nerve conduction velocity can be calculated.
  • a near-infra red spectroscope 309 • a near-infra red spectroscope 309.
  • a near IR source and sensor are used for detecting a tissue oxygen level by a spectral analysis of the light passing through the tissue.
  • the near IR analysis assists in detecting a patient condition.
  • differences in oxygenated blood as indicated by the near-IR analysis may be indicative of the condition, e.g. in the case of a stroke, or active seizures, the flow of oxygenated blood may be affected when compared to the other side.
  • the audible stimulation • means for generating an audible stimulation to the patient.
  • the audible stimulation is generated for producing a recordable brainstem auditory evoked potential (BAEP).
  • BAEP brainstem auditory evoked potential
  • the audible stimulation comprises sounding click sounds in the ipsilateral ear and background noise in the other ear, to isolate the tested side.
  • a light E.G LED, strobe light.
  • the visual stimulation is generated for producing a recordable visual evoked potential.
  • a pair of gloves are configured for communicating with each other and/or with a user interface.
  • communication is via wireless communication modules (e.g. Wi-Fi, Bluetooth).
  • a first glove of the pair is used for stimulation, and a second glove of the pair is used for measuring a response to the stimulation.
  • FIGs. 4A-F schematically illustrate examples of positions of a hand worn device comprising electrodes on a patient’s head, according to some embodiments.
  • Electrodes are positioned spread apart from each other. Alternatively, electrodes are clumped together.
  • FIG. 4A illustrates a position in which the device electrodes are arranged to measure from a frontal position, e.g. recording from the frontal and/or temporal lobes, according to some embodiments;
  • FIG. 4B illustrates a position in which the device electrodes are arranged to measure from a posterior position, e.g. recording from the occipital and/or parietal lobes, according to some embodiments;
  • FIG. 4C illustrates a position in which the device electrodes are arranged to measure from the right side of the head, such as from the right hemisphere;
  • FIG. 4D illustrates a position in which the device electrodes are arranged to measure from the left side of the head such as from the left hemisphere;
  • FIG. 4E illustrates a position in which the device electrodes are arranged to measure at a posterior position, according to some embodiments.
  • the electrodes are arranged in a cross or star pattern for average reference montage;
  • FIG. 4F illustrates a position in which the device electrodes are arranged to measure as a weighted average reference montage from either side of the head, according to some embodiments.
  • the electrodes are arranged in a cross or star pattern.
  • FIG. 5 describes EEG measuring schemes of electrodes mounted on a hand- worn device, according to some embodiments.
  • each channel representing a potential difference, for example as follows:
  • one of the electrodes is used as a reference/ground electrode (marked RG).
  • a reference/ground electrode marked RG
  • channels C1-C4 can be obtained (representing potential difference between Fl- RG, F2-RG, F3-RG, F4-RG).
  • Channels C5-C7 may be obtained by the combination of F1-F4 with each other (e.g. potential difference between F1-F2, F2-F3, F3-F4);
  • Channel C8 may be defined as a Laplacian channel, optionally averaging electrodes F1-F4.
  • channels C1-C8 are recorded simultaneously during an epoch.
  • analysis of the data acquired by the different channels comprises simultaneous feature extraction.
  • FIG. 6 is a flowchart of a method of generating a patient condition indication based on data acquired by a hand- worn device, according to some embodiments.
  • data recorded by the electrodes (such as EEG signals) is transferred to a processing unit, for example including a device processor, a remote server, a cloud server, and/or other.
  • a processing unit for example including a device processor, a remote server, a cloud server, and/or other.
  • patterns detected in the recorded data are compared to pre- established patterns, for example, patterns known in literature, patterns previously collected from the same patient; patterns collected from a plurality of patients, and optionally associated with the same condition, diagnosis and/or symptoms.
  • processing of the data includes identifying a local source of the bioelectrical signal based on the spatial position of the electrodes at the time of recording.
  • a remote device or server comprises a computer in a patient’s room, an ambulance, and/or other setting.
  • the device and/or user interface are configured to communicate with a database such as a hospital patient database (I.e. the electronic medical record - EMR).
  • the user is instructed to perform one or more additional recordings at one or more scalp positions.
  • the one or more positions differ from a previous recording position by a spatial location of at least one of the electrodes.
  • guidance is provided to the user, optionally via the user interface, to assist in positioning and/or instruct regarding a duration of recording, properties of the signal being currently recorded, improvement of contact with the scalp and/or others.
  • a protocol (or sequence) according to which recording is carried out is set based on user input, including for example current symptoms of the patient, an associated event, personal patient data, vital signs, etc.
  • a protocol according to which recording is carried out is set based on an initial recording, optionally one in which the user scans the patient’s head to detect and localize the approximate source of the abnormal signal.
  • real time analysis of the first recording allows for categorizing the patient condition into one of several categories, according to which diagnosis options are suggested and/or a protocol for additional measurements is proposed.
  • the additional data that was recorded is processed and then analyzed, and at 609, a patient condition indication is generated.
  • analysis of the data for reaching a condition related indication is performed in real time, for example within 30 seconds, 1 minute, 5 minutes, 10 minutes or intermediate, longer or shorter time periods from an initial recording.
  • FIG. 7 is a flow diagram of an exemplary method for processing data acquired by a hand- worn device, according to some embodiments.
  • a user presents a clinical problem, optionally inputting the problem via the user interface.
  • the user is guided, optionally by the user interface, to acquire data 705 (such as, but not limited to, EEG signals).
  • data 705 such as, but not limited to, EEG signals.
  • a plurality of recording channels e.g. 8 channels as described in FIG. 5 are used for measuring during, for example, 4 different epochs 709, each epoch performed for a time period of between, for example, 10-30 seconds.
  • recordings are performed not only from a head of the patient, but also from other anatomical locations, e.g. neck, heart, for example as shown at 711.
  • different data types are collected from various locations (e.g. ECG from the heart, evoked potentials, NCV, etc.).
  • an anatomical position is identified, and a recording protocol and/or analysis protocol are selected based on the identified position.
  • the position is identified via imaging, for example using an imager of the user interface device (e.g. cell phone camera). Additionally or alternatively, the position is identified based on indications from one or more position sensors of the device. Optionally, interpreting of the recorded data is based on the electrode positions, for example as indicated by the position sensors.
  • the measurement units are matched to the type of signal being recorded (e.g. for measuring ECG from the heart, the device switches to measurement in millivolts, for measuring EEG from the brain, the device switches to microvolts).
  • noise is reduced during recording, by instructing the user to apply a firm pressure while pressing the electrodes against the scalp, which may decrease impedance.
  • noise is reduced with the aid of active electrode sensors which apply minor current in a certain spot, and recording the change in the minor currents, for example in near- field and far- field electrodes.
  • noise is reduced (or removed) from the recorded data, for example by filtering the data, e.g. using a 1-50 Hz bandpass filter, or other high and/or low pass filter configurations.
  • noise is reduced by average summation of the recorded signals, thus reducing non-persistent signals (such as random or temporary frequency patterns) and amplifying common, repetitive patterns.
  • a notch filter is applied (compatible with the local power grid frequency - 50 or 60 Hz respectively).
  • noise reduction involves isolating the channels recorded by the device from the user’s bioelectricity effects and/or other ambient electromagnetic forces.
  • the recorded data is analyzed.
  • analysis is carried out by filtering the data recorded at the plurality of individual channels 712; applying feature extraction 713; and classification 714 to identify patterns.
  • algorithms such as FFT 710 are applied to convert the recorded signals to the frequency domain.
  • predefined EEG bands such as alpha, theta, beta, delta are sorted, and their power is measured.
  • presence of other specific morphologies and/or artifacts such as triphasic waves, epileptiform sharp waves, spikes, and/or other waveforms are detected.
  • waveforms detected are evaluated for rhythmicity and/or periodicity as their significance differs from a sporadic distribution of the same waveforms.
  • the detected patterns are compared to pre-established patterns.
  • a clinical problem (indication) is reached.
  • the acquired data confirms the initial problem suspected by the user or may offer insight regarding the appropriate differential diagnosis in view of presenting signs, symptoms and/or acquired electrodiagnostic data.
  • the collected data and/or associated clinical indication is optionally stored (e.g. in a device memory, clinical database and/or other).
  • the clinical indication is presented to the user, for example on a user interface screen.
  • significant wave patterns and a condition associated with these patterns may include: increased beta activity may be indicative of alcohol ingestion, use of benzodiazepines or barbiturates; Ictal or interictal epileptiform activity indicates tendency for focal or generalized seizures; triphasic waves may be indicative of metabolic derangements (e.g. liver or kidney failure); increased delta-theta power with subsequent decreased alpha-beta activity in a focal region may be indicative of a stroke (either ischemic or hemorrhagic), but not limited.
  • FIGs. 8A-G are examples of user interface screens of a hand-held device used to control a hand-wom electrode array, according to some embodiments.
  • the user interface is designed and configured to receive input from the user and/or patient; to guide the user during data acquisition; and/or to provide feedback, such as a differential diagnosis, options for continuing treatment, and/or other output.
  • a chief complaint screen including check boxes for indicating one or more of: pain, sensory loss, motor loss, sight loss and/or other.
  • a screen for inputting additional symptoms is presented.
  • the options listed are tailored to the selections in the chief complaint screen. For example, if motor loss or weakness is indicated for both legs, the proposed list of symptoms is set to include“urine retention” and/or“back pain”. In another example, in the case of right arm and leg weakness, the system will inquire regarding symptoms such as“aphasia”,“headache”.
  • the user is presented with guidance and/or feedback for acquiring data.
  • guidance is selected according to the inputted symptoms.
  • the interface presents a graphical indication of the electrode positions; instructions for improving contact if needed; a progress indication (e.g. hourglass, progress bar, and/or other time or progress presenting feature) indicating a remaining duration for recording at a current position; and optionally graphs showing the currently and/or previously recorded signals, as analyzed in real time.
  • a progress indication e.g. hourglass, progress bar, and/or other time or progress presenting feature
  • the interface allows a user to consult an expert, save the data, share the data (e.g. with a physician), and/or reset/start over.
  • data is sent from an emergency medical service to a neurologist, allowing a stroke team at the hospital to optimize care for the patient.
  • the emergency medical team may be routed with the patient to a suitable hospital with brain catheterization competence, therefore potentially saving valuable time and improving patient outcome, thus reducing hospital and post hospital costs.
  • FIG. 9 is a flow diagram of an exemplary method of using optical means for assisting in positioning of a hand- worn device on a patient, according to some embodiments.
  • positioning of the hand worn device 901 is assisted by imaging means suitable for identifying a current electrode position.
  • imaging means suitable for identifying a current electrode position In the example shown, augmented reality glasses 905 are shown.
  • a user wears the glasses while placing the hand-worn device on the patient.
  • the glasses are programmed to display one or more layers of information regarding the organ of interest, the anatomical context of the data being recorded, electrophysiology data acquired by the device, time progress indication, the next device position, and/or other operational data.
  • the glasses include a camera 907 directed to acquire images and/or a video of the hand- worn device in order to assess its position.
  • glasses 905 communicate with the user interface 909.
  • User guidance e.g. re positioning
  • the device position is tracked in space (for example by tracking the position of the fingers).
  • computerized reconstruction of the position is performed to determine a location of the device with respect to the organ of interest (or parts thereof).
  • FIG. 10 illustrates an example of using optical means in the form of augmented reality glasses for assisting in positioning of a hand-wom device on a patient, according to some embodiments.
  • glasses 1001 are configured to display to the user various data, including, for example: a current position of electrodes 1003; details regarding the current epoch 1005; time progress (e.g. time until the next epoch) 1007; differential diagnosis of the patient 1009; a graphical representation of the analyzed data of interest 1011; graphs indicating, for example, the spectral power of predetermined EEG frequency bands, as calculated in the current and/or previous epoch 1013.
  • FIG. 11 is a flowchart of a method of using a hand-wom device for stimulating a patient’s body part and/or for detecting a response to the stimulation, according to some embodiments.
  • an electrical stimulation is applied to the patient, for example to a patient’s limb (e.g. arm, leg).
  • a simulating device comprises circuitry suitable for applying an electrical stimulation, for example comprising an anode, cathode and grounding element.
  • the hand-wom device comprises a stimulating module.
  • other devices such as a sleeve or clip comprising a stimulating module may be used.
  • a current of 15-35mA is applied for an upper limb); a current of 30-60mA is applied for a lower limb.
  • the stimulation is applied gradually, until capturing a cortical response and/or other response detected along the neural pathway (i.e. the Evoked Potentials). Occasionally, higher intensities are applied.
  • a stimulation pulse duration is between 100-300 microseconds.
  • a duration of the recorded epoch varies based on the type of potential measured (e.g. 200 ms for VEP, 100ms for SSEP).
  • an anatomical area e.g. the patient’s head
  • an anatomical area is recorded from to detect an evoked potential in response to the applied stimulation.
  • evoked potentials are measured to evaluate a limb numbness and/or weakness.
  • measuring evoked potentials may assist in differentiating between a weak or numb limb that is due to a spinal injury, or a weak or numb limb due to a thalamocortical injury.
  • Conditions that may be assessed by detecting evoked potential may include: myelitis, multiple sclerosis, plexopathy, other myelopathy - compressive or not, and/or or stroke (in which case all neural tract will be intact, except for cortical response).
  • stroke there may be specific signature in the EEG pattern of that region, and absent thalamocortical response with normal rest of neuraxins relevant to the weak limbs.
  • a response to the stimulation may be recorded from various organs or anatomical areas, such as the scalp, brachial or lumbosacral plexus, spinal regions, peripheral nerve, and/or other.
  • FIG. 12 illustrates applying stimulation to a patient and detecting a response to the stimulation using at least one hand-wom device, according to some embodiments.
  • a user wears a pair of hand-worn devices 1201, 1203 one on each of the left and right hands.
  • the user places one device 1201 on the patient’s arm, for applying an electrical stimulation; and the second device 1203 on the patient’s head, for measuring an evoked potential in response to the stimulation.
  • the user wears a pair of AR glasses 1205, for example as described hereinabove.
  • guidance for applying stimulation is provided to the user, for example via the glasses and/or other user interface.
  • FIG. 13 illustrates exemplary anatomical positions for stimulating and detecting a response to the stimulation using at least one hand-worn device, according to some embodiments.
  • a user places a hand worn device 1301 in contact with the patient’s scalp 1303 for recording a cortical response to the applied limb stimulation.
  • the user may then move the hand worn device to a different anatomical position (1305), for example as required by a specific study paradigm.
  • the new anatomical position may include a patient’s cervical spine and Erb point if stimulating the upper limb (positions 2,3), or the T12-Iliac crest region and Popliteal fossa if stimulating the lower limb (positions 4,5).
  • stimulation is applied by a sleeve, but it can alternatively be applied by a second - stimulating glove.
  • the patient suffers from limb weakness or numbness, and recording of evoked potentials is performed to determine the location of discontinuity of neural signal, most likely responsible this condition, for example being one or more of brain pathology, cervical or thoracolumbar myelopathy or other spine pathology, spinal nerve root pathology and/or more peripheral large nerve pathology.
  • the hand-wom device is moved along the neural path leading to the limb.
  • inability to record an evoked response in an anatomical landmark but ability to record evoked response downstream may indicate interruption of transmission between the last anatomical landmark in which signal was recorded, and the one upstream.
  • Examples of recording positions shown in this figure include: CPc (centroparietal- contralateral); Fpz (frontopolar midline); CPi (centroparietal-ipsilateral); C5s (5 th cervical spine region); EPc (Erb’s point contralateral); EPi (Erb’s point ipsilateral); T12 (12 th thoracic spine region); IC (Iliac crest); Popliteal region, and/or other positions for example as referred to in “American Clinical Neurophysiology Society. Guideline 9D: guidelines on short-latency somatosensory evoked potentials.” J Clin Neurophysiol 2006;23(2): 168-179), and/or as described in other medical approved guidelines and electrophysiology manuals.
  • FIGs. 14A-B schematically illustrate applying a renewable conductive gel onto a hand- worn device (FIG. 14A) and a magazine of finger-tip electrodes (FIG. 14B), according to some embodiments.
  • a user in between patients and/or in between epochs, places the electrode tips of the hand-worn device 1401 in high viscosity conductive gel or paste 1403.
  • the gel coating improves electrical conductivity when the electrodes are placed in contact with the scalp.
  • the gel further acts to clean the electrode tips, for example by comprising disinfectant material.
  • the gel is viscous.
  • the gel coating on the electrode is a few mm thick, for example, between 0.5-3 mm thick.
  • the gel is applied warm, and when cooled at room temperature, the gel solidifies to produce a relatively harder coating. The gel may be removed by dipping the electrodes in warm water or the like.
  • FIG. 14B shows an example of a magazine 1405 of electrodes, according to some embodiments.
  • a user places their covered finger (covered by the glove sheath) into the magazine to pick up an electrode from the stack of electrodes, optionally by a Snap-On connection. This may be performed between different patients, to replace the used electrodes with a new set.
  • the whole device e.g. glove
  • the whole device is disposable, and is replaced between patients.
  • cleaning and/or sterilizing methods may be applied, for example, spraying the device with a disinfectant aerosol.
  • FIGs. 15A-B schematically illustrates a mechanism 1500 for providing haptic feedback to a user of a hand worn device, according to some embodiments.
  • the hand-worn device comprises means for providing tactile feedback to the user, for example during electrode positioning, and/or for indicating that recording is taking place.
  • a mechanism 1500 for providing tactile feedback to a user comprises a set of opposing plates 1501 coupled to each other by one or more springs 1503.
  • a rotating unit 1507 positioned in between the plates comprises a distinct curvature.
  • a distance between the two plates varies in response to rotation of the unit relative to a rotation axis 1509.
  • the rotating unit 1507 may either push the plates or apart or allow the plates to be pulled closer to each other due to pulling by the springs.
  • mechanism 1500 is located on an inner surface of the glove sheath, optionally within the lining of the glove.
  • electrode 1511 i.e., the electrode base
  • the lining of the sheath comprises an insulating material.
  • the user presses their finger tip, covered by the glove material, for example against the patient’s head, thereby applying pressure onto the electrode.
  • the one or more elastic elements e.g. springs
  • the extent of compression of the springs is a result of the amount of pressure applied by the user onto the electrode.
  • haptic feedback generated by mechanism 1500 is defined as a result of the signal types and/or patterns currently acquired by electrode 1511, in a pre- established pattern.
  • a soft wavy movement may indicate a focal slowing in the area being investigated;
  • a sharp“tapping” haptic feedback may indicate the presence of sharp waves (epileptiform activity).
  • the feedback pattern and optionally the bioelectrical pattern which triggers it are pre-established and programmed into the system.
  • a visual marker 1513 is positioned atop the user’s finger, e.g. approximately above the finger nail, on an external side of the glove.
  • Visual marker 1513 is, in some embodiments, detectable by the user interface, for example via an image acquired by the user interface.
  • FIG. 16 schematically illustrates applying a visual stimulation to a patient and detecting a response to the stimulation using a hand worn device, according to some embodiments.
  • a hand-worn device and interface for example as described herein may be used for assessment and/or detection of a plurality of conditions.
  • a visual stimulation is applied, for example using a light stimulator of the hand-wom device and/or other stimulating means.
  • the device (such as a second device worn on the user’s second hand) is then placed on the patient’s head to detect an evoked potential in response to the stimulation.
  • measurements are performed to compare functioning of one eye to the other.
  • the shown example further illustrates the possibility of recording Brainstem Auditory Evoked Potentials (BAEP), for example by measuring potential differences between positions Cz and A 1/Ml.
  • BAEP Brainstem Auditory Evoked Potentials
  • Epilepsy using the device, a rapid and initial diagnosis of seizure or interictal epileptiform activity may be provided, thus indicating possible seizure disorder and general characteristics of the seizure. This may provide an advantage over standard 10-20 EEG, which is usually not immediate and readily available, and commonly depends on technical and expert personnel.
  • EEG electronic glycol
  • the patient can be provided with benzodiazepines immediately.
  • Stroke the hand-worn device may detect focal anomaly and potentially accelerate triage examination. If a large area seems to be affected, EMS may suspect a large vessel occlusion and rout the patient to a facility capable of brain catheterization and mechanical thrombectomy. Thus, saving time, brain and improving patient outcome by reducing disability.
  • Head injury and/or headache commonly seen by medical personnel and cleared from injury using imaging means such as CT or MRI.
  • imaging means such as CT or MRI.
  • Use of the hand- worn device for recording EEG may influence the clinical judgement and avoid un-necessary imaging often performed without indication. This may reduce costs and reduce exposure of the patient to radiation.
  • Brain malignancy the hand-worn device may increase suspicion of a tumor, for example by detecting focal changes (this is a non-specific method but will prompt use of specialized imaging like MRI).
  • the hand- worn EEG device may assist obtaining triage for imaging.
  • the hand-worn device may detect encephalopathy.
  • the device can be used for pointing out possible etiologies (i.e. presence of interictal epileptiform activity may indicate a post-ictal state, presence of triphasic waves may indicate a metabolic cause, excess beta activity may indicate benzodiazepine or barbiturate intoxication, etc.)
  • Anoxic Brain damage following prolonged resuscitation, may appear as myoclonic status epilepticus, burst suppression patterns, and other patterns depending on severity.
  • the hand-worn device may assist in rapid determination of patterns, optionally contributing to prognostics and guiding treatment efforts.
  • Spinal injury, myelopathy may be detected by recording somatosensory evoked potentials, for example by using a stimulator and a hand-wom device (or a set of two devices), for example as described herein.
  • stimulation is applied to the wrist and/or ankle, and the recording glove is placed in pre-determined anatomical landmarks along the neural path relevant to the affected limb(s).
  • Plexopathy recording somatosensory evoked potentials, for example by using a stimulator and a hand-wom device (or a set of two devices), for example as described herein may assist in in forming of clinical judgement, for example determining the need for imaging and/or the type of imaging required in the presence of limb weakness and/or numbness.
  • the device may be used for applying stimulation and/or for recording nerve conduction velocity (NCV) along the neural path assessing for increased latencies or conduction blocks.
  • NCV nerve conduction velocity
  • Hearing loss by applying an audible stimulation (optionally via the hand-worn device and/or user interface, e.g. via headphones) a brainstem auditory evoked potential (BAEP) may be recorded. Findings may indicate sensorineural hearing loss or possible higher order disturbance.
  • an audible stimulation optionally via the hand-worn device and/or user interface, e.g. via headphones
  • a brainstem auditory evoked potential (BAEP) may be recorded. Findings may indicate sensorineural hearing loss or possible higher order disturbance.
  • Chest pain the hand worn device may be used for recording electrocardiogram, potentially detecting cardiac ischemia.
  • Neurodegenerative disease e.g. Alzheimer’s, etc.
  • the patient can be presented with certain images and/or sounds, and event related potentials (ERPs) can be recorded in response by the hand-wom device.
  • ERPs event related potentials
  • FIG. 17 is a photo of a prototype of a hand worn device for recording EEG signals, according to some embodiments.
  • a set of electrodes 1701 (in this example, dry electrodes) are mounted at the tips of finger sheaths of a glove 1703.
  • Circuitry 1705 for electrode recording extends from each of the electrodes to an analog to digital converter and to other supporting circuitry, including circuitry for communicating with the computer via Bluetooth and/or Wi-Fi and circuitry connected to a power source (not shown in the image).
  • FIG. 18 shows various modalities for use of a hand-worn device, according to some embodiments.
  • the hand- worn device is constructed for obtaining one or more of several information types, including, but not limited to: Electroencephalography (EEG), Electrocardiogram (ECG) data; Nerve Conduction Velocity (NCV) data; Visual Evoked Potentials (VEP); Brainstem Auditory Evoked Potentials (BAEP); Somatosensory Evoked Potentials (SSEP), Near Infra-Red Spectroscopy (NIRS) and/or other diagnostic data.
  • EEG Electroencephalography
  • ECG Electrocardiogram
  • NCV Nerve Conduction Velocity
  • VEP Visual Evoked Potentials
  • BAEP Brainstem Auditory Evoked Potentials
  • SSEP Somatosensory Evoked Potentials
  • NIRS Near Infra-Red Spectroscopy
  • NIRS Near Infra-Red Spectroscopy
  • compositions, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
  • a compound or “at least one compound” may include a plurality of compounds, including mixtures thereof.
  • range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
  • method refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.
  • the term“treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

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Abstract

Certains modes de réalisation de la présente invention concernent un dispositif porté à la main pour l'enregistrement d'EEG chez un patient, comprenant : au moins deux gaines, chaque gaine étant formée et dimensionnée pour s'adapter au doigt d'un utilisateur, chaque gaine comprenant une électrode montée sur une surface externe de la gaine ; et un circuit conçu pour acquérir et traiter des signaux d'EEG enregistrés chez un patient par les électrodes et pour communiquer les signaux d'EEG enregistrés à un dispositif distant.
PCT/IL2020/050814 2019-07-22 2020-07-22 Dispositif de mesure électrophysiologique porté à la main WO2021014445A1 (fr)

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WO2010129026A2 (fr) * 2009-04-29 2010-11-11 Bio-Signal Group Corp. Ensemble pour électroencéphalographe
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