WO2017060560A1 - Agencement pour conduire des mesures d'électrode - Google Patents

Agencement pour conduire des mesures d'électrode Download PDF

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Publication number
WO2017060560A1
WO2017060560A1 PCT/FI2015/050676 FI2015050676W WO2017060560A1 WO 2017060560 A1 WO2017060560 A1 WO 2017060560A1 FI 2015050676 W FI2015050676 W FI 2015050676W WO 2017060560 A1 WO2017060560 A1 WO 2017060560A1
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WO
WIPO (PCT)
Prior art keywords
electrodes
arrangement
electrode
skin
measurement data
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PCT/FI2015/050676
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English (en)
Inventor
Jari KELLOKOSKI
Reijo Lappalainen
Pasi LEPOLA
Esa MERVAALA
Katja MYLLYMAA
Sami MYLLYMAA
Kirsi SIPILÄ
Juha TÖYRÄS
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University Of Eastern Finland
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Priority to PCT/FI2015/050676 priority Critical patent/WO2017060560A1/fr
Publication of WO2017060560A1 publication Critical patent/WO2017060560A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • 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
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282—Holders for multiple electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/291—Bioelectric electrodes therefor specially adapted for particular uses for electroencephalography [EEG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/296—Bioelectric electrodes therefor specially adapted for particular uses for electromyography [EMG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4538—Evaluating a particular part of the muscoloskeletal system or a particular medical condition
    • A61B5/4542—Evaluating the mouth, e.g. the jaw
    • A61B5/4557—Evaluating bruxism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • 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
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6814—Head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • 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
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6822—Neck
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0412—Low-profile patch shaped housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0443—Modular apparatus
    • A61B2560/045—Modular apparatus with a separable interface unit, e.g. for communication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0214—Capacitive electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0215—Silver or silver chloride containing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/043—Arrangements of multiple sensors of the same type in a linear array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/166—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted on a specially adapted printed circuit board
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
    • A61B5/259—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes using conductive adhesive means, e.g. gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/30—Input circuits therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/398—Electrooculography [EOG], e.g. detecting nystagmus; Electroretinography [ERG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4812—Detecting sleep stages or cycles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4818—Sleep apnoea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • 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
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6823—Trunk, e.g., chest, back, abdomen, hip

Definitions

  • the invention relates to the field of medical technology, more specifically to the arrangement and method for determination of sleep stages, associated events and objective diagnosis of sleep bruxism and other sleep disorders.
  • apnea-hypopnea index i.e. apneas plus hypopneas per hour of sleep
  • AHI apnea-hypopnea index
  • type II devices including EEG channels
  • Type II devices are intended to offer a complete sleep evaluation in an attended surrounding at patients' home, allowing not only the diagnosis of sleep disordered breathing, but also other sleep disorders like periodic leg movements during sleep, central sleep apnea, insomnia and sleep bruxism.
  • REM sleep rapid eye movement
  • NREM sleep non-rapid eye movement
  • AASM American Academy of Sleep Medicine
  • AASM AASM
  • scalp electrodes to measure EEG in PSG two frontal electrodes (F3 and F4), two central electrodes (C3 and C4), and two occipital electrodes (Ol and O2).
  • two mastoid electrodes Ml and M2 are used as reference electrodes.
  • the primary recording derivations are F4-M1, C4-M1 and O2-M1.
  • another set of electrodes are attached to another side of scalp in order to record the back-up derivations F3-M2, C3-M2 and O1-M2.
  • the AASM also recommends the use of left and right EOG derivations (E1-M2 and E2-M2) and chin EMG (primary channel and back-up channel).
  • Attaching cup electrodes on the scalp sites requires preparation of the skin, that is, mechanical scraping of the skin to remove the dead surface layer (epidermis), and dosing of a conductive me- dium (electrode gel). Finally, the adhesion of the electrodes is ensured by different attachment systems, such as tapes, bands, nets, caps or adhesive fixing paste. The preparations for measurement thus require a lot of experience and special know-how.
  • a measuring wire connected to each electrode makes the measuring connection rigid and uncomfortable, hindering the patient's normal movements and sleep, and may thus cause motion artefacts and other interferences in the measuring signal and thus complicate the interpretation of the sleep recording data. It is easily understood that this kind of electrode setup is not suitable for patient self-application.
  • the operating time of the electrode is said to be 4 hours.
  • This prior art implementation in question may be suitable for paramedic and intensive care unit use, but not for several other EEG examinations, such as long- term sleep studies. Especially that is not suitable for patient self-application.
  • Bruxism is defined as a repetitive jaw-muscle activity characterized by clenching or grinding of the teeth and/or by bracing or thrusting of the mandible.
  • Bruxism has two distinct circadian manifestations: it can occur during sleep (indicated as sleep bruxism) or during wakefulness (indicated as awake bruxism).
  • Sleep bruxism is associated with a number of clinical problems, including muscle and joint pain, awakening headache, dental damage and loss of dental implants.
  • Several methods are used in the diagnostics of sleep bruxism. A recent international consensus statement proposed a new diagnostic grading system of "possible”, “probable”, or "definite” SB depending on diagnostic technique employed.
  • Self-reported questionnaires yield only a 'possible' diagnosis of bruxism.
  • clinical evaluations may be utilized that include an examination of wear patterns of the teeth combined with patient interview yielding probable diagnosis of sleep bruxism.
  • Polysomnography (PSG) is the gold standard method for assess- ment of sleep bruxism.
  • EMG electromyographic
  • RMMA rhythmic masticatory muscle activity
  • In-lab PSG is the most reliable method yielding "definite" diagnosis of sleep bruxism but unfortunately this technique is applicable only to a small fraction of patients due to the high cost and limited availability. Better solutions are needed for wide use and screening.
  • the Bruxoff (SpesMedica, Genova, Italy) is a three channel portable monitor able to simultaneously record EMG activity bilaterally from the masseter muscles and the heart frequency.
  • this system is not suitable for determination of sleep architecture or for detection of neurophysiological phenomena recently known to be associated with sleep bruxism.
  • the etiology of sleep bruxism is multifactorial and still partly unknown.
  • different morphological factors like occlusal discrepancies and the anatomy of the bony structures, have been considered as main factors for bruxism.
  • recent studies have given evidences that these factors play only a small role, if any. Sleep bruxism appears to be mainly regulated centrally, not peripherally.
  • the patent publication US8588883B2 relates to a method and an apparatus for monitoring activity of the temporal and/or masseter muscle, in particular temporal and/or masseter muscle activity due to bruxism.
  • the electrode assembly comprises three electrodes in a fixed spatial relationship one to another.
  • this electrode measurement arrangement does not include electrodes located on the area of forehead, chin or chest to enable the re- cording of electrical activity of the brain or muscles or heart, respectively. Due to these shortcomings this arrangement is not suitable to reliable determination of sleep stages or objective diagnosis of sleep bruxism.
  • WO2014072582A1 an arrangement for carrying out electrode measurement on the surface of skin of a patient's head for recording the electrical activity of the brain.
  • This arrangement comprises a matrix electrode configuration comprising a body part of non- conductive material conforming to the contours of the surface of the skin.
  • the arrangement comprises electrodes for producing the measurement data connected to the said body part, means for transmitting said measurement data and a measurement data unit for receiving said measurement data for further processing.
  • the body part comprises an electrode placement configuration for maintaining the mutual placement of the electrodes essentially the same with respect to one another and further comprises an active attachment surface located between the electrodes and the surface of the skin for forming a firm and electro-conductive contact between the electrodes and the surface of the skin.
  • this electrode measurement arrangement does not include electrodes located on the area of chin or cheeks to perform the recording the electrical activity measurement of muscle activity. Due to these shortcomings this arrangement is not suitable to reliable determination of sleep stages or objective diagnosis of sleep bruxism.
  • the aim of this invention is to eliminate and reduce the problems relating to the prior art measurement systems and to allow reliable sleep bruxism and other polysomnography studies cost-efficiently at home.
  • the aim of the invention is to realize an electrode measurement implementation for determining the sleep architecture and sleep bruxism events by recording simultaneously electroencephalography (EEG), electrooculography (EOG) and electromyography (EMG) signals.
  • an arrangement for carrying out electrode measurements on the surface of the skin of a patient comprising electrodes for producing measurement data and an active attachment surface located between the electrodes and the surface of the skin for forming a firm and electroconductive attachment contact be- tween the electrodes and the surface of the skin for transmitting measurable signals from the patient to the electrodes through said electroconductive active attachment surface to produce measurement data, said electroconductive active attachment surface comprising hydrogel or other electroconductive adhesive material which adheres well to the skin in order to form a sta- ble and essentially interference-free attachment contact between the electrodes and the skin surface.
  • the arrangement for carrying out at least one hour sleeping time or non-sleeping time electrode measurements comprises a matrix electrode configuration, which comprises a body part of non- conductive material conforming to the contours of the surface of the skin, and which body part comprises an electrode placement configuration for maintaining the mutual placements of the electrodes essentially the same with respect to one another, and which arrangement comprises electrodes being arranged to measure electroencephalography (EEG) signals and electromyography (EMG) signals, at least one electrooculography (EOG) electrode to measure eye movements, at least one electrode attached in the pa- tient's chest area for carrying out electro cardiac measurements (ECG), and electrodes for performing jaw region measurements, means for transmitting the measurement data obtained by said electrodes, said means for transmitting being connected to the body part, and a measurement data unit for receiving the measurement data transmitted by said means for further pro- cessing of the measurement data.
  • EEG electroencephalography
  • EMG electromyography
  • EOG electrooculography
  • ECG electrooculography
  • ECG electrooculography
  • the invention is based on a matrix electrode configuration, which comprises a body part of non-conductive material conforming to the contours of the surface of the skin, and an electrode placement configuration for maintaining the mutual placements of the electrodes essentially the same with respect to one another.
  • the invention is further based on electrodes which are arranged to measure electroencephalography (EEG) signals and electromyography (EMG) signals, at least one electrooculography (EOG) electrode to identify eye movements, at least one electrode attached in the patient's chest area for carrying out electro cardiac measurements (ECG), and electrodes for performing jaw region (EMG) measurements.
  • EEG electroencephalography
  • EMG electromyography
  • EOG electrooculography
  • Extensive sweating on fore head and tempus areas can cause shortcircuiting or detachment of electrodes.
  • these large areas surrounding electrodes are preferably perforated or semipermeable or composed of water vapor transparent films to allow easy removal of moisture by water vapor evaporation.
  • This kind of perforation or similar may be implemented on the body part 100, but excluding the areas of the active electrodes 110a.
  • the benefit of the invention is that it enables carrying out simultaneous electroencephalography (EEG), electromyography (EMG), electrooculography (EOG), cardiac measurements (ECG), and jaw region measurements by so simple and easy measurements that a patient even can set up the whole system by itself at home, which makes easy overnight recording possible and affordable.
  • Fig. 1 presents an exemplary assembly on patients face according to present invention.
  • Fig. 2 presents an exemplary matrix electrode configuration according to the present invention.
  • Fig. 3 presents one preferred embodiment according to the present invention.
  • Fig. 4 presents one exemplary embodiment about the details of the electrode structure.
  • a facial assembly is presented.
  • the assembly may be e.g. in connection with a breast collar.
  • the patient may be connected e.g. to electrocardiography sensors, a pulse oximeter and/or respisratory effort belts detecting the movements of chest and abdomen and/or nasal cannula pressure transducers detecting respiratory airflow.
  • the plurality of sensors may be integrated into one measurement system. Further sensors may be inte- grated also with the body part 100 of the present invention.
  • Fig. 2 is shown an embodiment with three separate connectors according to the present invention.
  • Fig. 3 is shown an embodiment with one connectors according to the present invention.
  • Fig. 4 is presented a more detailed look at the electrode structure.
  • the electrodes 102 are spiral shaped and of conductive silver.
  • the means 104 for transmitting are surrounded by an insulation 106.
  • the attachment surface 110a shown in an exploded view to make the inner structure of the electrodes and transmitting means visible, is of hydrogel and the areas of the body part 100 nearby the electrodes 102 are of medical foam 110b.
  • the electrodes may be shaped as platy (as disclosed in Figs. 2 and 3), spiral (as in Fig. 4) dactylate, meshy or such. They may also said to be disc, elliptic disc, ring, finger-like shape, snake-like shape or spiral shape.
  • an arrangement for carrying out electrode meas- urements on a surface of skin of a patient comprises electrodes 102 for producing measurement data and an active attachment surface 110 located between the electrodes 102 and the surface of the skin for forming a firm and electroconductive attachment contact between the electrodes and the surface of the skin for transmitting measurable signals from the patient to the electrodes through said electroconductive active attachment surface 110 to produce measurement data.
  • Said electrocon- ductive active attachment surface 110 comprises hydrogel or other electro- conductive adhesive material which adheres well to the skin in order to form a stable and essentially interference-free attachment contact between the electrodes 102 and the skin surface.
  • the arrangement according to the present invention is arranged for carrying out at least one hour sleeping time or non-sleeping time electrode measurements.
  • the arrangement comprises a matrix electrode configuration, which comprises a body part 100 of non-conductive material conforming to the contours of the surface of the skin.
  • FIG 2 is presented an exemplary matrix electrode configuration according to the present invention.
  • the body part 100 comprises an electrode placement configuration 108 for maintaining the mutual placements of the electrodes essentially the same with respect to one another.
  • the arrangement according to the present invention comprises electrodes being arranged to measure electroencephalography (EEG) signals and electromyography (EMG) signals, at least one electrooculography (EOG) electrode to measure eye movements, at least one electrode 102 attached in the patient's chest area for carrying out electro cardiac measurements (ECG), and also electrodes for performing jaw region measurements.
  • the arrange- ment further comprises means 104 for transmitting the measurement data obtained by said electrodes, said means 104 for transmitting being connected to the body part 100, and the arrangement comprises a measurement data unit for receiving the measurement data transmitted by said means 104 for further processing of the measurement data.
  • the means 104 for trans- mitting the measurement data can be implemented by wired or wireless signal transmission techniques.
  • the wireless means 104 comprises transmitter for sending the measurement data and a receiver for receiving the measurement data.
  • the wired means 104 that comprise transmission lines, in which the measurement data is transmitted.
  • Said lines 104 can be e.g. opti- cal cables or electrical wires.
  • the electrodes are made of Ag/AgCI surrounded by a hydrogel collar or ring.
  • the breathing movements are detected by respiratory effort belts fastened around the chest and/or abdomen.
  • respiratory airflow can be detected by nasal cannula pressure transducers.
  • the sensors further to include a thermistor located in front of patients mouth.
  • the body part 100 can comprise an electrode placement configuration 108 for maintaining the mutual placements of the electrodes 102 essentially the same with respect to one another for easy attachment of the matrix electrode construction in the hairless skin areas of the patient's head by means of the active attachment surface 110.
  • Each electrode attaches to its intended measuring point in the said hairless skin areas of the head.
  • the active at- tachment surface can comprise an electroconductive surface 110a and a non-conductive surface 110b.
  • the electrode placement configuration may include the placement of electrodes El and E2 on the level of the patient's eyes and the orientation of the electrodes LM1 and LM2 is such that they are parallel to the muscle fibres. Further, the distance of the electrodes may be optimized such, that they both are on a muscle for maximizing the signal intensity.
  • the word "hair” is supposed to mean only the hair growing from persons head, which can grow into length of dozens of centimeters if not specifically cut. This term should not be understood to mean the fluffy skin hair around the human body, neither is it supposed to mean any facial fair or other male or female typical hair growth on the skin. It is to be understood, that the hairless areas of the skin can include skin hair or facial hair.
  • the arrangement for carrying out electrode measurements can comprise an optimised electrode configuration to provide an essentially good signal-to-noise ratio (S/N), as well as magnetic resonance imaging (MRI) and computed imaging (CT) compatibility.
  • the arrangement for carrying out electrode measurements can comprise integrated wiring and measurement electronics enabling patient to use the arrangement independently.
  • FIG 3 is presented one preferred embodiment according to the present invention in which electrodes and transmission lines are incorporated into a solid body. Only one connector is then needed.
  • FIG 2 is presented one preferred embodiment of an arrangement for carrying out measurement for determination of sleep stages and detecting of sleep bruxism events according to the present invention.
  • the arrangement comprises a matrix electrode configuration, which comprises a body part 100 of non-conductive material conforming to the contours of the surface of the skin. Electrodes 102 are produced e.g. using screen printing technique on the body part for picking bio-signals (e.g. EEG, EOG, EMG, ECG) from human body.
  • the transmission lines 104 for transferring the measurement data are also connected to the body part.
  • the transmission lines are, for example, screen-printed silver conductor lines which transfer bio-signals from electrodes to e.g.
  • the measurement and storage data unit is, for example, sleep monitor attached to the patient's chest, through which measurement data is further transferred to computer unit for scoring and diagnostic examinations.
  • the breathing movements can be detected by a respiratory effort belts fastened around the chest and/or abdomen. Further, respiratory airflow can be detected by nasal cannula pressure transducers.
  • the sensors may further include a thermistor located in front of patients mouth. The attachment of nasal cannula/thermistor can be integrated with the body part 100 of the present invention. Additionally, further sensors may be added in the system.
  • EMG electrodes located on the legs to detect movement of legs, especially for restless leg syndrome; inertia sensors for motion tracking and/or sleep position; temperature sensor, for body temperature; sensors for measuring galvanic skin response; snoring sensors; and transcutaneous C0 2 sensors. These sensors can be connected either by wired or wirelessly to a measurement data unit for further processing.
  • the body part 100 comprises an electrode place- ment configuration 108, by means of which the mutual placements of the electrodes are maintained essentially the same with respect to one another. Electrodes 102 attached to the solid body part are adhered preferably on the patient's forehead, temple, cheek, jaw and behind the ears.
  • the arrangement for carrying out electrode measurements may comprise at least one electrode attached in the patient's chest area for carrying out electro cardiac measurements (ECG).
  • ECG electro cardiac measurements
  • HRV heart rate variability
  • PWA pulse wave amplitude
  • the active attachment surface 110 based on hydrogel immediately provides a stable contact with the skin which may last over the night.
  • the matrix electrode is relatively simple and eco- nomical and thus suitable to be disposable.
  • the matrix electrode is delivered sterilized in a disposable package.
  • the matrix electrode configuration according to the invention can be formed, for example, by a method of implementation based on screen printing technique.
  • As the body part (base layer) of the matrix electrode is used a thin polymer film, such as Mylar, Kapton, polyester, polyethene, polypropene or polyimide film, which conforms to the contours of the face.
  • the electrodes and their transmission lines are thick-film structures made of conductive ink (e.g.
  • the body part of the matrix electrode is coated with insulating material (insulant layer) to avoid short-circuiting of the wires.
  • insulating material for example, AG602, Amgel Technologies,
  • hydrogel layer is covered with a protective layer (release liner layer) which gives support during the mounting of the electrode.
  • release liner layer also protects the electrodes from drying; the film may be, for example, a thin plastic film, which is torn off at the stage when the attachment of the electrode is begun.
  • All transmission lines 104 preferably end in the projecting part of matrix electrode, from which the recorded bio-signals are guided by means of a quick coupling to an amplifier/sleep monitor.
  • an arrangement for carry out measurement for determination of sleep stages and detecting of sleep bruxism events consists of total of 17 electrodes (Fig. 2). From these electrodes, there are six EEG electrodes (Fpl, Fp2, Af7, Af8, T9, T10, see figure), two EOG electrodes (El, E2), and bipolar electrode pairs for measuring the electrical activity of masseter muscles (LM1, LM2), reference elec- trade (Ref) and ground electrode (Gnd). If necessary, it is possible to use T9 and T10 as a reference or connect Ref and Gnd together in a measuring device or in the electrode embodiment. This increases the contact area of grounding and may improve the signal quality.
  • a separate electrode set for measurement of electrical activity of chin muscle (EMGl, EMG2, EMGF) is used. It is clear that this chin muscle set can also be incorporated in the main part of the matrix electrode configuration.
  • the Ag/AgCI electrodes 102 are integrated on the body part 100. On the insulation, there is a hole in the same location.
  • the size if the structure is preferably about 6mm- 10mm, more preferably about 7mm-9mm and most preferably approximately 8mm.
  • the size of the hydrogel disc above the electrode may be about 22mm-26mm, more prefer- ably 23mm-25mm, and most preferably approximately 24mm.
  • the width of the transmission lines is preferably 0.5mm-1.5mm, more preferably 0.75mm- 1.25mm and most preferably approximately 1.00mm.
  • the size or diameter of the central area of the electrodes T9 and T10 may typically be approximately 20mm.
  • the matrix electrode described in the invention can be implemented with very different techniques, for example, with thin film and lithographic methods, silk-screen printing technique, printing techniques, various lamination techniques, etc.
  • the arrangement according to the invention for carrying out electrode measurements can be utilized and used, for example, in the following applications.
  • TST total sleeping time
  • Particular merit of invention is a very accurate determination of TST that enables relia- ble determination of many sleep indices such as apnea-hypopnea index (AHI, events/h) that uses TST as the denominator.
  • the present invention therefore offers a significant advancement in portable sleep studies.
  • the invention makes simultaneous measurement of EEG, EOG, ECG and EMG signals possible with a simple matrix electrode that is easy and quick to apply.
  • the simple construction of the invention enables, that the patient can perform electrode self-application and administration of whole testing without the need of nurse/sleep technician.
  • the recording can be therefore carried out in the natural patient environment, at home.
  • the invention enables reliable sleep bruxism investigations yielding "definite" diagnosis of sleep bruxism without the limitations of high cost and poor availability of present gold standard methodology.
  • the full polysomnography setup consists of electroencephalography (EEG), electrooculography (EOG) and chin electromyography (EMG) recording to allow determination of sleep stages and cortical arousals. Since the invention is easy and quick to apply, it is particularly useful for studies carried out outside the particular sleep labora- tories since no special neurophysiological expertise and skills are required to place it, in contrast to prior the art electrodes.

Abstract

Un objet de la présente invention est un agencement pour conduire des mesures d'électrode sur la surface de la peau d'un patient. L'agencement pour effectuer des mesures d'électrode sur au moins une heure de temps de sommeil ou de temps de non-sommeil comprend une configuration d'électrodes matricielle, qui comprend une partie de corps (100) de matériau non conducteur se conformant aux contours de la surface de la peau, et ladite partie de corps (100) comprend une configuration de placement d'électrodes (108) pour maintenir les placements mutuels des électrodes essentiellement identiques les uns par rapport aux autres, et ledit agencement comprend des électrodes étant agencées pour mesurer des signaux d'électroencéphalographie (EEG) et des signaux d'électromyographie (EMG), au moins une électrode d'électro-oculographie (EOG) pour mesurer les mouvements des yeux, au moins une électrode (102) fixée à la zone thoracique du patient pour effectuer des mesures électrocardiaques (ECG), et des électrodes pour effectuer des mesures de région de mâchoire, des moyens (104) pour transmettre les données de mesure obtenues par lesdites électrodes, lesdits moyens (104) de transmission étant raccordés à la partie de corps (100), et une unité de données de mesure pour recevoir les données de mesure transmises par ledit moyen (104) pour le traitement ultérieur des données de mesure.
PCT/FI2015/050676 2015-10-08 2015-10-08 Agencement pour conduire des mesures d'électrode WO2017060560A1 (fr)

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JP2019025070A (ja) * 2017-07-31 2019-02-21 株式会社東芝 眼電位検出装置、帽子及びヘッドウェア
WO2023239460A1 (fr) * 2022-06-09 2023-12-14 Georgia Tech Research Corporation Système de capteur pouvant être porté sans fil souple et procédé de détection de qualité et de troubles du sommeil

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US20050131288A1 (en) * 2003-08-15 2005-06-16 Turner Christopher T. Flexible, patient-worn, integrated, self-contained sensor systems for the acquisition and monitoring of physiologic data
US20080243020A1 (en) * 2005-10-08 2008-10-02 Chang-An Chou Physiological Signal Collecting And Monitoring Device And System
WO2009061920A1 (fr) 2007-11-06 2009-05-14 Hydrodot, Inc. Dispositif et procédé pour réaliser une électroencéphalographie
US20110251469A1 (en) * 2010-04-09 2011-10-13 The Board Of Trustees Of The University Of Arkansas Wireless nanotechnology based system for diagnosis of neurological and physiological disorders
US8588883B2 (en) 2007-09-21 2013-11-19 Sunstar Suisse Sa Electrode assemblies and bruxism monitoring apparatus
WO2014072582A1 (fr) 2012-11-12 2014-05-15 Mega Electronics Ltd Agencement et procédé de réalisation de mesures d'électrode

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EP0951233B1 (fr) 1996-10-11 2005-03-16 Aspect Medical Systems, Inc. Systeme d'ensemble d'electrodes permettant de mesurer des signaux electrophysiologiques
US20050131288A1 (en) * 2003-08-15 2005-06-16 Turner Christopher T. Flexible, patient-worn, integrated, self-contained sensor systems for the acquisition and monitoring of physiologic data
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019025070A (ja) * 2017-07-31 2019-02-21 株式会社東芝 眼電位検出装置、帽子及びヘッドウェア
WO2023239460A1 (fr) * 2022-06-09 2023-12-14 Georgia Tech Research Corporation Système de capteur pouvant être porté sans fil souple et procédé de détection de qualité et de troubles du sommeil

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