The present invention pertains to the field of electroencephalogram (EEG) devices. In particular, the invention relates to an in-ear electroencephalography device. Said device is particularly configured to enable the diagnosis, monitoring or treatment of neurological or physiological diseases or disorders requiring electrical brain activity measurements.
The EEG is a sample of electrical brain activity. A minimum of 20 minutes of artefact-free recording (including activation procedures) is necessary to assess baseline brain electrical activity. Longer recordings improve the chance of recording an abnormality and of demonstrating their variability. Moreover, the medical monitoring of persons undergoing their usual activities is useful in many cases. Thus, monitoring means must not disrupt or disturb the subject's life, for example in the case of the elderly, during sleep or in other situations.
The present invention aims at providing a device that measures electrical brain activity for a long period of time, for example for more than 20 minutes, while being compact, comfortable, ergonomic and easy to use. Such a device allows an easier examination and a more reliable diagnosis and/or monitoring.
The present invention relates to an in-ear device comprising a cloth defining a concave surface, at least one electrode in or on said cloth, and at least one conductive track connected to said at least one electrode. In a preferred embodiment, said cloth has a shape of a sleeve which has dimension adapted to fit into at least a portion of the auditory canal of an ear of a patient. Advantageously, the hollow shape of the cloth allows the in-ear device of the invention to be highly multifunctional. Indeed, the hollow shape of the cloth allows to accommodate into the ear of a subject nor only the in-ear device but also any other desired object and/or instruments matching the dimension of the in-ear device and the ear of the subject. Therefore, advantageously the EEG recording may be acquired from the electrodes of the in-ear device for example, while an object is attenuating the sound that reaches the ear (i.e., ear plug) or while an ear speaker diffuses a sound into the ear.
According to one embodiment, said cloth is a knitted textile, a non-woven textile, a woven textile or a combination thereof. Advantageously, the use of a textile cloth improves the comfort of the subject carrying the in-ear device into his/her auditory canal.
Preferably, said cloth is made of polyamide.
According to one embodiment, said at least one electrode is a textile electrode that is woven, knit, stitched, stuck or deposited in or on said cloth.
In one embodiment, said at least one electrode and/or said conductive track is made of silvered polyamide, advantageously allowing an improved comfort for the subject that needs to wear the in-ear device during many hours.
According to one embodiment, said in-ear device comprises at least two electrodes, preferably at least 3 electrodes, more preferably at least 4 electrodes, even more preferably at least 5 electrodes.
In one embodiment, said electrodes are disposed on either side of a plane that passes through the longitudinal axis of the in-ear device, and faces each other.
In another embodiment, said electrodes are disposed on either side of a plane that passes through the longitudinal axis of the in-ear device, and are shifted from each other's.
In another embodiment, said electrodes are disposed on either side of a plane perpendicular to the longitudinal axis of the in-ear device.
According to one embodiment, said in-ear device further comprises an ear plug that is at least partially surrounded by the cloth. In this embodiment, the ear plug is configured to be fitted inside the hollow space of the sleeve shape cloth and therefore has dimension adapted to fit the cloth and, as consequence, the ear canal of a subject.
In one embodiment, said in-ear device further comprises an instrument such as a microphone or an earphone, said instrument is at least partially surrounded by the cloth. In this embodiment, the ear plug is configured to be fitted inside the hollow of the cloth and therefore has dimension adapted to fit the cloth and, as consequence, the ear canal of a subject.
The present invention also relates to a method of monitoring neurological or physiological diseases or disorders, comprising the setting up of an in-ear device according to the present invention in an ear of a subject and the measurement of an electrical activity.
The present invention also relates to a method of collecting electroencephalography data, comprising the setting up of an in-ear device according to the present invention in an ear of a subject and the measurement of an electrical activity.
The present invention further relates to a process for manufacturing an in-ear device comprising the following steps:
In the present invention, the following terms have the following meanings:
The present invention relates to an in-ear device comprising a cloth defining a concave surface, at least one electrode in or on said cloth, and at least one conductive track connected to said at least one electrode.
According to one embodiment, said concave surface is a sleeve. Said sleeve can be either open at both ends, open at one end and closed at the other end, or closed at both ends.
Preferably, said sleeve is closed at least at one end, more preferably said sleeve is open at one end and closed at the other end (see
The in-ear device and in particular the cloth is dimensioned so as to be insertable into the ear canal of a subject. According to one embodiment, the shape of said cloth is like the shape of an ear plug (see
According to a preferred embodiment, the shape of said cloth is a cone whose beginning diameter h is about 8 mm, whose end diameter H is about 10 mm, and whose length L is about 25 mm.
In one feature, said cloth is at least slightly elastic, in order to advantageously conform to the shape of the ear canal. The elasticity of said cloth allows the manufacture of only one size of said cloth as if it is sufficiently elastic so that it can fit various adult ear canals.
The material of the cloth is compatible with skin contact and is non-conductive. According to one embodiment, the cloth is made of textile. Preferably, said cloth is a knitted textile, a non-woven textile, a woven textile or a combination thereof. The use of a knitted textile and/or a woven textile for manufacturing the cloth advantageously provides the desired elasticity to said cloth. More preferably, said cloth is made of polyamide. Even more preferably, said cloth is a knitted textile made of polyamide, such as the polyamide 6,6.
Advantageously, said cloth is seamless, for example a seamless knitted cloth. The absence of seams improves comfort as it allows the surface of the cloth to be smooth. In addition, a smooth surface improves the quality of contact between electrode and skin of the subject, and hence improves the quality of electrical signal measured.
The in-ear device comprises at least one electrode in or on the cloth that defines a concave surface. Said at least one electrode is(are) able to measure electrical brain activity. The in-ear electrode should be comfortable in order to permit the wearer to sleep. The electrode should if possible, not be elastic in order to have a constant size. The material of the in-ear electrode should be compatible for skin contact.
According to one embodiment, said at least one electrode is a textile electrode that is woven, knit, stitched, sticked or deposited in or on said cloth. According to a preferred embodiment, said at least one electrode is made of silvered polyamide. According to another preferred embodiment, said at least one electrode is made by two-yarns knitting, one yarn being of polyamide 6,6 and one yarn being of silvered polyamide.
Preferably, the cloth of the in-ear device is a knitted textile and the at least one textile electrode(s) is/are knitted in said knitted cloth. In other words, the cloth and the at least one electrode represent only one textile, said textile comprising areas made of conductive yarns and areas made of non-conductive yarns, delimiting conductive areas that are the at least one electrode(s) and insulating areas that are the cloth. In this embodiment, the in-ear device is a seamless knitting, which is more comfortable and provide with better electrical signal because it has a smooth surface. More preferably, the conductive yarns are silvered polyamide yarns and/or the non-conductive yarns are polyamide 6,6 yarns.
Alternatively, the conductive areas are made by two-yarns knitting, one yarn being of polyamide 6,6 and one yarn being of silvered polyamide, and the insulating areas are made by knitting polyamide 6,6 yarns.
Moreover, concerning polyamide 6,6 and silver polyamide, the biocompatibility of the polyamide 6,6 and of silver is well-known, they are very safe materials.
According to another embodiment, said at least one electrode is made of an elastic ink that comprises silver or silver chloride, and is preferably deposited on said cloth.
According to one embodiment, said in-ear device comprises one electrode (see
According to alternative embodiment, the in-ear device comprises 2, 3, 4, 5 or 6 electrodes (see
The at least one electrode of said in-ear device can be positioned in or on said cloth in any way suitable for measurements of electrical signal.
In one embodiment, the position of the electrodes is invariable by rotation along the axis of the cloth. If there is rotational symmetry along the axis of the cloth, there is no need to orient the direction of the cloth in the ear of the subject, and therefore the use of the in-ear device is easier.
In one embodiment, said electrodes are disposed on either side of a plane that passes through the longitudinal axis of the in-ear device, and facing each other. In another embodiment, said electrodes are disposed on either side of a plane that passes through the longitudinal axis of the in-ear device, and shifted from each other's. In another embodiment, said electrodes are disposed on either side of a plane perpendicular to the longitudinal axis of the in-ear device.
The in-ear electrode should go deep in the ear, as deep as an ear plug (about 23 mm). Preferably, the at least one electrode starts at between 1 and 6 mm from the top of the concave-shaped cloth, preferably at between 2 mm and 5 mm, more preferably at about 4 mm (the deepest part in the ear).
According to one embodiment, the length of the at least one electrode is between 10 and 20 mm, preferably between 12 and 18 mm, more preferably between 15 and 17 mm, even more preferably about 15 mm or about 17 mm; and the width of the at least one electrode is between 1 and 8 mm, preferably between 2 and 6 mm, more preferably between 4 and 5 mm, even more preferably about 4 mm or about 5 mm For example, as shown in
In one embodiment, the at least one electrode has shape and dimension to form a closed loop around the cloth of the in-ear device.
The shape of the electrodes may be any shape suitable for measuring electrical brain activity, for example square, round, oval, rectangular, diamond shaped etc.
According to one embodiment, said at least one electrode does not require gel for use, preferentially said at least one reference electrode is a dry conductive electrode.
As explained above, the cloth is elastic and has dimension and shape adapted to fit the auditory canal the subject. Notably, such a cloth allows to ensure a contact between the in-ear device and internal walls of the auditory canal. The electrodes of the in-ear device are made of conductive material allowing to record the electric activity from the inner wall of the auditory canal without the need of a gel, such as electrolytic cream. The electrodes of the in-ear device are as well adapted for use with a gel. The electrolytic cream may allow to improve the conductivity between the skin and the electrode, thus improving the electrical signal measured. Advantageously, the textile structure of the cloth absorbs the electrolytic cream and releases said cream once the in-ear device is in place in the ear channel; this ensures that there is enough cream on said electrodes and prevents the cream from spreading out on the cloth between said electrodes, which can produce short circuits.
The in-ear device comprises a cloth defining a concave surface, at least one electrode in or on said cloth, and a conductive track connected to said at least one electrode. Preferably, there is one track per electrode.
According to one embodiment, said conductive track is a textile track, preferably a knitted textile track, more preferably a textile track made by knitting silvered polyamide yarns.
In one embodiment, said track goes from the electrode to the edge of the cloth or further than the edge of the cloth for the electrical connection to an acquisition system of electrical brain activity.
Preferably, the conductive track is positioned inside the cloth of the in-ear device in order to be not in contact with the skin outside the auditory canal.
According to an advantageous feature, the materials of the in-ear device, for example polyamide 6,6 for the cloth and silvered polyamide for the at least one electrode and the at least one conductive track, allows said in-ear device to be washed at least 20 times (in conditions suitable to remove ear wax) and/or is of sufficient low price to be disposable. For example, the in-ear device can be washed in a laundry washing machine.
The in-ear device has a thickness that allows to have a large specific surface area in contact with skin and/or electrolytic cream when said in-ear device is crushed in the ear of a subject, which lowers the contact impedance and improves the EEG signal quality. For example, the thickness of said in-ear device is between 0.1 and 5 mm, preferably between 0.1 and 3 mm, more preferably between 0.1 and 1 mm, even more preferably between 0.1 and 0.5 mm, even more preferably between 0.2 and 0.4 mm, even more preferably about 0.3 mm.
According to one embodiment, the in-ear device according to the present invention, as described above, further configured to cooperate or comprises an ear plug and/or an instrument, the cloth being configured to fit the ear plug and/or the instrument. In one feature, the cloth is removably slipped on the ear plug and/or the instrument. For example, the instrument can be a microphone or an earphone. For example, the ear plug can be a foam ear plug, such as an earplug made of polyurethane. Notably, the ear plug and/or the instrument is inserted in the hollow of the sleeve-shaped cloth so that the ear plug and/or the instrument is at least partially surrounded by the cloth. Moreover, the ear plug and/or the instrument has dimensions adapted to fit the auditory canal when inserted into the hollow of the sleeve-shaped cloth. In one preferred embodiment, the outer shape of the ear plug and/or the instrument fits the inner surface of the cloth so that when the in-ear device is inserted into the auditory canal, the ear plug and/or the instrument pushes the electrodes against the internal wall of the auditory canal.
The in-ear device can also further comprise an ear plug and several instruments, provided that the cloth of said in-ear device can fit them. Alternatively, the in-ear device can also further comprise several instruments and no ear plug, provided that the cloth of said in-ear device can fit these instruments.
Indeed, as the cloth of the in-ear device has a concave surface, its hollow allows to put an ear plug and/or an instrument. When the cloth fit at the same time an ear plug and an instrument such as an earphone or a microphone, the ear plug can have been cut at its top in order to allow space for said instrument.
As mentioned above, the cloth of the in-ear device can be at least slightly elastic; this elasticity of said cloth allows the manufacture of only one size of said cloth as if it is sufficiently elastic it can fit the various adult ear canal and the various ear plug sizes.
According to one embodiment, said in-ear device is connected to an acquisition system configured to acquire the signal measured by the at least one electrode and the connexion is detachable. The acquisition system comprises an electronic circuit.
In one embodiment, said acquisition system further comprises a signal processing means. According to one embodiment, said signal processing means comprises a memory unit, said memory unit comprising neurological markers; and the signal processing means is configured to identify a neurological disorder among the signals measured by the at least one electrode based on the neurological markers.
For example, the memory unit can comprise epileptic markers; the identification of epileptic activity among the signals measured by the at least one electrode can use an epileptic activity recognition algorithm based on a neural network analysis.
According to one embodiment, the signal processing means of the in-ear device is configured to identify or annotate the side-effects of a medical treatment via an electronic data collection, said side-effects resulting in changes to electrical brain activity. This collection may be direct (input of subject's data in a software application) or indirect (collection via a third-party computing system).
According to one embodiment, the signal processing means is configured to identify the subject's sleep cycles based on the various signals acquired by the acquisition system.
According to one embodiment, the in-ear device also comprises or is connected to at least one remote storage means and means for communicating to at least one cloud computing or remote server type remote storage means.
Advantageously, said acquisition system further comprises means for transmitting the electrical signal acquired by the acquisition system to said signal processing means. The transmission means is configured to transmit the electrical signals acquired by the acquisition system to the signal processing means. In one embodiment, the signal processing means is remote from this device and is connected wirelessly. In one embodiment, the signal processing means is remote from this device and is connected in a wired manner.
Preferably, the in-ear device comprises a cloth defining a concave surface, at least one electrode in or on said cloth, a conductive track connected to said at least one electrode, and is connected to an acquisition system, which comprises a transmission means and a signal processing means. In one embodiment, the in-ear device comprises a plurality of acquisition systems, transmission means and signal processing means.
An object of the present invention is also a process for manufacturing an in-ear device comprising the following steps:
According to one embodiment, the insulating yarn used in step i. is a polyamide 6,6 yarn.
According to one embodiment, the conductive yarn used in step i. is a silvered polyamide yarn.
According to one embodiment, the insulating yarn used in step i. is a polyamide 6,6 yarn and the conductive yarn used in step i. is a silvered polyamide yarn. One advantage of using polyamide for both cloth and electrode is that the cloth and the at least one electrode as a whole is homogeneous and similarly flexible in all points.
According to one embodiment, the conductive track at step ii. is made by knitting silvered polyamide yarn.
In one embodiment, said cloth and said at least one electrode are knitted on an automatic knitting machine which ensures a better manufacturing quality and reproducibility and which lowers the manufacturing cost, allowing to consider a single-use of the cloth comprising the at least one electrode.
The automatic knitting machine may be of the glove knitting type, with a special program for knitting the textile at least one electrode. For example, said knitting machine can be the machine whose reference is SWG041 and which is manufactured by the company SHIMA, with 240 needles and a gauge of 15.
After step i., once the cloth comprising at least one electrode is knitted, some yarns are shaved and the cloth comprising at least one electrode is washed according to an industrial process called “end of production”. This washing process ensures the cleaning of the sizing oils (used to facilitate knitting) and cleans possible handling stains.
The present invention also relates to a method of monitoring neurological or physiological diseases or disorders, comprising the setting up of an in-ear device in an ear of a subject and the measurement of electrical activity.
The present invention further relates to a method of collecting electroencephalography data, comprising the setting up of an in-ear device in an ear of a subject and the measurement of electrical activity.
According to one embodiment, the in-ear device can be used for capturing an EEG of a subject. This EEG is a useful for diagnosing, monitoring and/or treating neurological or physiological diseases or disorders requiring electrical brain activity measurements, such as epilepsy or sleep disorders.
The invention also relates to the use of an in-ear device according to the present invention, for monitoring neurological or physiological diseases or disorders requiring electrical brain activity measurements.
Advantageously, the device can be set up on a subject by the subject himself or by any other person such as health or non-health professional. Normally mucous membranes of the auditory canal are protected by wax but for a better skin electrode contact the patient will be asked to clean the wax of his/her ears. An electrolytic cream can be used on the at least one electrode.
The size, location and texture of the device, that is an in-ear device comprising a cloth, improves discreetness and user comfort, especially over long periods of time. The in-ear device is comfortable in order to permit the wearer to sleep. For example, for a polysomnography examination, the subject has to wear the device for a period between 4 hours and 48 hours.
Advantageously, the integration of textile electrode(s) such as electrode(s) made of silvered polyamide yarns, in or on the fabric or textile of the cloth, allows a better comfort for the subject that needs to wear the in-ear device during many hours.
The present invention enables a reliable analysis of the electrical brain signal measured by detecting the periods during which said signal is disturbed.
The in-ear device maybe used with the 10-20 international system, the 10-10 system or the 10-5 system.
While various embodiments have been described and illustrated, the detailed description is not to be construed as being limited hereto. Various modifications can be made to the embodiments by those skilled in the art without departing from the true spirit and scope of the disclosure as defined by the claims.
As shown in
The cloth 1 has the following dimensions (see
As shown in
Without wishing to be limited by any theory, using devices in both ears allows for further distance between the active electrode(s) and the reference electrode(s), so as to increase the electrical potential difference.
Said in-ear device illustrated in
Number | Date | Country | Kind |
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20305446.5 | May 2020 | EP | regional |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2021/061991 | 5/6/2021 | WO |