WO2016055154A1 - Dispositif pour appliquer un stimulus électrique transcutané - Google Patents

Dispositif pour appliquer un stimulus électrique transcutané Download PDF

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Publication number
WO2016055154A1
WO2016055154A1 PCT/EP2015/001958 EP2015001958W WO2016055154A1 WO 2016055154 A1 WO2016055154 A1 WO 2016055154A1 EP 2015001958 W EP2015001958 W EP 2015001958W WO 2016055154 A1 WO2016055154 A1 WO 2016055154A1
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WO
WIPO (PCT)
Prior art keywords
signal
tone
electrodes
measured resistance
ear
Prior art date
Application number
PCT/EP2015/001958
Other languages
German (de)
English (en)
Inventor
Andreas HARTLEB
Original Assignee
Cerbomed Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cerbomed Gmbh filed Critical Cerbomed Gmbh
Publication of WO2016055154A1 publication Critical patent/WO2016055154A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear

Definitions

  • the invention relates to an apparatus for applying a transcutaneous electrical stimulation stimulus to the surface of a portion of the human ear having a number of electrodes disposed on or in an electrode carrier, the apparatus comprising a controller which controls the production of a potential difference between the electrodes the device comprising signal means which can indicate or indicate a signal which depends on the resistance between the electrodes when the potential difference is present and in the device placed on or in the ear, the signal means comprising a tone generator and a loudspeaker element, wherein the signal means is adapted to convert a dependent of the measured resistance signal by means of the tone generator into an associated audio signal, wherein the audio signal is outputable via the speaker element.
  • a device of the generic type disclosed in DE 10 2013 021 175 AI Similar and other solutions are described in US 5 514 175 A and US 2009/0082831 Al.
  • CONFIRMATION COPY It is generally known to influence the neurophysiological and neuroelectric quality and thus the function of the stimulated nerves by invasive and non-invasive stimulation of the nerves. As a result, various disease states can be treated. There are numerous devices for both invasive and non-invasive stimulation.
  • the present invention focuses on the method of transcutaneous electrical nerve stimulation.
  • pulse currents of different current forms, amplitudes, pulse durations and frequencies are applied through the skin to different nerves and change their status parameters in an advantageous manner.
  • a device for transcutaneous stimulation of the vagus nerve from DE 10 2010 054 165 B3 is known.
  • a device whose electrode head is arranged with two electrodes in the area of the cymbal conchae; Such positioning of the electrodes has proved to be advantageous.
  • the area of the cymba conchae is the area of the concha of the ear, which lies above the crus helicis; it is also called Hemiconcha superior. Below the crus helicis downwards extends the area of the cavum conchae.
  • the present invention is based on the object of providing a device of the type mentioned, with which it is possible for the patient or user of the device in a simple manner to position the stimulation device in the ear in such a way that the best possible contact quality for the stimulation is achieved can. Accordingly, the optimal position of the device for efficient transcutaneous stimulation should be easily found.
  • the solution to this problem by the invention is characterized in that the tone generator is designed such that it generates a sound signal as a function of a change in the measured resistance within a predetermined time (resistance gradient).
  • the loudspeaker element can be arranged on the device in such a way that it comes to lie near the auditory canal in the case of a device attached to or in the ear, or even protrudes into it.
  • the tone generator can be designed to generate a tone signal which generates a tone of defined frequency as a function of the measured resistance gradient.
  • the tone generator is designed to generate a sound signal that generates a tone of defined amplitude (volume) as a function of the measured resistance gradient.
  • the tone generator is designed to generate a tone signal which generates a defined speech output as a function of the measured resistance gradient.
  • the tone generator is designed to generate a tone signal which generates a tone sequence with a predetermined sequence of individual tone signals as a function of the measured resistance gradient; the individual audio signals then have the same frequency and the same volume (but not necessarily).
  • the tone generator can accordingly generate a tone signal which generates a sequence of tones with different rapid succession of the individual tone signals as a function of the measured resistance gradient, for example in such a way that the speed with which the tone signals follow one another slows down as the contact quality deteriorates and accelerated as the contact quality improves.
  • the signaling means are preferably firmly connected to the device.
  • the speaker element may comprise a speaker diaphragm. But it is also possible that the speaker element is or comprises a piezoelectric crystal. Furthermore, it is possible for the loudspeaker element to be designed to output particularly low-frequency tones or to comprise such an element, ie in this case it is a vibrating or oscillating element, the vibration or oscillation not being (only) acoustically, but also on the vibration sense of the skin (father-Pacini body / Corpusculum lamellosum) is perceptible.
  • the electrode carrier is preferably designed such that it comes to rest with the electrodes in the cymbal conchae when the device is attached to or in the ear.
  • the stimulation quality which is to be achieved in that the user or patient of the device feedback (feedback) is given by the device on the contact quality. This is done by means of acoustic signals.
  • the same information is given to the user as to how he may need to change the position of the electrodes on the skin surface in order to achieve a better result.
  • this is preferably a tone with a defined volume or pitch - the device thus gives the user an indication of how it is ordered to the contact quality of the electrodes. It can then be moved by the user, for example, by "trial and error" of the electrode head on the skin surface until an improved contact quality has set, which is signaled by the sound and in particular its volume or frequency.
  • the user may, inter alia, take the following measures: the change in position of the electrode pair relative to the skin, in particular in the area of the cymbal conchae, may include a translational movement of the electrode head; this movement can generally be provided in all directions on the skin surface and parallel to it.
  • the Stimulationsort can then also by circular pivoting of the Electrode or the electrode carrier can be changed in one place. It can also be made a pivoting of the electrode formed by the plane of the electrodes relative to the skin level in order to achieve a higher degree of parallelism to the skin surface. It can also be a change - usually in the form of an increase - the contact pressure of the electrodes on the skin are envisaged.
  • the audible signal may indicate that the skin under the electrode and / or the electrode itself must be cleaned.
  • the electrodes are provided with structural means for increasing or equalizing the contact conditions (eg a "shell" for the electrode carrier).
  • the information by means of the signal means provided according to the invention in this case provides an indicator with regard to the electrical Resistance between the electrodes of the stimulation device (or for its reciprocal, ie for the electrical conductivity).
  • a test current of 100 .mu. ⁇ can be used as the basis and the signal means the voltage required to achieve said test current.
  • the audio signal changes, so that the user of the device knows that now a position of the stimulation device and, in particular, its electrodes is found, which is suitable for transcutaneous stimulation.
  • the optimal stimulation range must be delimited not only upwards (in the direction of high voltages) but also downwards, for which purpose the above-mentioned "short circuit" is referenced. If the contact quality is too good, possibly even before contact with the ear (for example, if too much contact gel has been applied, which establishes an electrically conductive connection between the electrodes before insertion into the ear), the user of the device should also be audible References to the optimization, analogous to the high voltage, but then also at too low voltage.
  • a defined voltage can be specified, which must be applied for the achievement of a test current.
  • the resistance defined by the required voltage for achieving the desired current, is within the therapeutically effective range up to a permissible limit value.
  • the resistance (corresponding to the required voltage to reach a desired current) may be too high because the contact quality between the skin and the electrode is insufficient.
  • the resistance may be too low; There is then a short circuit across the skin surface from the stimulation to the reference electrode, without the skin and thus the receptive fields of the nerves are flowed through by the current. Accordingly, according to the proposed concept, it may be provided that the current status of the contact quality is signaled by characteristic sounds by means of the loudspeaker element to the user of the device.
  • the measured resistance values may vary depending on the specific circumstances and on the individual user, so that it is sometimes difficult to determine values ranges for the resistance or the contact voltage in advance, ie before a concrete application be signaled to the user via loudspeaker element.
  • a development provides that the ranges for the measured values and the resulting characteristic tones are individually determined or at least adapted, ie set. So the system would be able to learn so far or it can adapt itself to concrete circumstances in the sense of self-learning software. In this case, it can therefore be provided that a software is used for the operation of the stimulation device, which is "self-learning" and automatically carries out corresponding adaptation.
  • the user of the device would be constantly informed if he is on the right track in the search for optimal positioning of the electrodes.
  • a device 1 for transcutaneous stimulation of a portion of the human ear 2 is sketched.
  • the device 1 has a holding rod 8, which is longitudinally displaceable in a base part, which also comprises a control device 6.
  • a support part 9 is arranged at the base part.
  • the general positioning of the device 1 in the ear 2 results from the marking of the essential regions of the ear 2, namely the pinna P with the cavum conchae Ca, the cymbal conchae Cy, the tragus T and the crus helicis Cr.
  • an electrode support 5 is arranged, which has two electrodes 2 and 4, between which a potential difference is established for the purpose of transcutaneous stimulation.
  • the device 1 initially corresponds to previously known solutions, reference being particularly and expressly made to DE 10 2010 054 165 B3 of the patentee, where such a device is explained in more detail.
  • the device 1 is accordingly designed to be attached to the ear 2 of the person using the device in the region of the vagus nerve. This can be done a transcutaneous stimulation of the vagus nerve.
  • the device 1 in the present case comprises signal means 7 which indicate or indicate the electrical resistance prevailing between the electrodes 3 and 4 when the device is attached to or into the ear 2.
  • These signal means 7 comprise a tone generator 7 'and a loudspeaker element 7 "which, depending on the measured resistance, emit a sound signal into the auditory canal of the user of the device
  • the signal means 7 comprises a tone generator 7' and a loudspeaker element 7";
  • the signal means 7 is designed so that it can convert the measured resistance between the electrodes 3, 4 by means of the tone generator 7 'in a sound signal, which is assigned to the measured resistance. The sound signal is then output via the loudspeaker element 7 "directly into the auditory canal of the ear 2.
  • the measured electrical resistance changes, so that depending on this - in the sense of the above explanations - by means of the tone generator 7 'a tone defined pitch (frequency) is generated.
  • the user hears this sound via the loudspeaker element 7 "and thus experiences immediately whether there are good or at least suitable conditions for carrying out a transcutaneous stimulation If, for example, the pitch is in a conspicuously high (or low) range (eg higher than 1,000 Hz), this can signal to the user that the contact quality is not good and a repositioning of the electrode carrier 5 with the electrodes 3, 4 is required Frequency below 200 Hz), the user knows that the contact quality is now good or good. If the resistance is too high, a contact gel can provide a remedy; if the resistance is too low, it may be necessary to clean / degrease the electrodes or the electrode carrier (contact gel) or the skin surface.
  • the optimum position for the stimulation can be found by observing the sound output from the speaker element 7 ".
  • the stimulation device 1, and in particular its electrode carrier 5 is displaced over the surface of the skin until the user hears a characteristic sound via the loudspeaker element 7 "(for example a tone with a frequency below 200 Hz), which signals to him that the contact quality is now good.
  • the tone generator 7 ' may advantageously be designed such that it generates a tone signal as a function of a change in the measured resistance within a predetermined time (ie a resistance gradient corresponding to a change in resistance per time).
  • the signal means 7 and in particular the tone generator 7 ' monitors the prevailing resistance between the electrodes 3, 4 and determines the difference between two measured resistance values which occur at the beginning and at the end of a predetermined time interval (e.g. 0.5 seconds).
  • a predetermined time interval e.g. 0.5 seconds
  • the resistance gradient (AR / At) can then be determined and a tone signal generated therefrom
  • a tone signal generated therefrom
  • an assigned high-frequency sound can be generated, with a low resistance gradient a low-frequency sound can be generated
  • a speech output takes place in plain text, that is to say, for example, to place the stimulation device optimally in the ear, successfully or unsuccessfully or to improve or worsen the contact quality.
  • “poor contact quality” or “good contact quality” as soon as the right or at least one useful for the stimulation position of the electrode carrier is found.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Otolaryngology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un dispositif (1) pour appliquer un stimulus électrique transcutané à la surface d'une section de l'oreille humaine (2), qui présente un certain nombre d'électrodes (3, 4) qui sont disposées sur ou dans un support (5) d'électrode, le dispositif (1) comprenant un dispositif de commande (6) qui commande ou régule la réalisation d'une différence de potentiel entre les électrodes (3, 4), le dispositif (1) comprenant des moyens de signal (7), qui peuvent indiquer ou donner un signal qui dépend de la résistance qui existe entre les électrodes (3, 4) à la différence de potentiel appliquée et en fonction du dispositif (1) placé sur ou dans l'oreille (2), le moyen de signal (7) comprenant un générateur de son (7') et un élément haut-parleur (7"), le moyen de signal (7) étant réalisé de manière telle qu'il peut transformer un signal dépendant de la résistance mesurée au moyen du générateur de son (7') en un signal de son associé, le signal de son pouvant être émis via l'élément haut-parleur (7"). Pour pouvoir trouver de manière simple la meilleure qualité de contact possible pour la stimulation, selon l'invention, le générateur de son (7') est réalisé de manière telle qu'il génère un signal de son en fonction d'une modification de la résistance mesurée en un laps de temps prédéfini.
PCT/EP2015/001958 2014-10-11 2015-10-06 Dispositif pour appliquer un stimulus électrique transcutané WO2016055154A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102014015079.8A DE102014015079B4 (de) 2014-10-11 2014-10-11 Vorrichtung zur Aufbringung eines transkutanen elektrischen Stimulationsreizes
DE102014015079.8 2014-10-11

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WO2016055154A1 true WO2016055154A1 (fr) 2016-04-14

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107519573A (zh) * 2017-09-30 2017-12-29 武汉资联虹康科技股份有限公司 一种具有指示灯的耳夹电极
CN107582375A (zh) * 2017-09-30 2018-01-16 武汉资联虹康科技股份有限公司 一种具有光纤传导的耳夹电极

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102016001093A1 (de) 2016-02-02 2017-08-03 Cerbomed Gmbh Stimulationsvorrichtung

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5514175A (en) * 1994-11-09 1996-05-07 Cerebral Stimulation, Inc. Auricular electrical stimulator
US20090082831A1 (en) * 2007-09-21 2009-03-26 Paul Zachary D Vestibular Stimulation System
WO2011030210A1 (fr) * 2009-09-14 2011-03-17 Medizinishe Universität Wien Appareil de stimulation ponctuelle
DE102010054165B3 (de) * 2010-12-12 2012-05-24 Cerbomed Gmbh Elektrodenanordnung
US20120191161A1 (en) * 2011-01-24 2012-07-26 Cochlear Limited Systems and Methods for Detecting Nerve Stimulation with an Implanted Prosthesis
DE102011018228A1 (de) * 2011-04-19 2012-10-25 Cerbomed Gmbh Vorrichtung und Verfahren zur Aufbringung eines transkutanen elektrischen Stimulationsreizes auf die Oberfläche eines Abschnitts des menschlichen Ohrs

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102013021175B4 (de) * 2013-12-17 2015-10-22 Cerbomed Gmbh Vorrichtung zur Aufbringung eines transkutanen elektrischen Stimulationsreizes

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5514175A (en) * 1994-11-09 1996-05-07 Cerebral Stimulation, Inc. Auricular electrical stimulator
US20090082831A1 (en) * 2007-09-21 2009-03-26 Paul Zachary D Vestibular Stimulation System
WO2011030210A1 (fr) * 2009-09-14 2011-03-17 Medizinishe Universität Wien Appareil de stimulation ponctuelle
DE102010054165B3 (de) * 2010-12-12 2012-05-24 Cerbomed Gmbh Elektrodenanordnung
US20120191161A1 (en) * 2011-01-24 2012-07-26 Cochlear Limited Systems and Methods for Detecting Nerve Stimulation with an Implanted Prosthesis
DE102011018228A1 (de) * 2011-04-19 2012-10-25 Cerbomed Gmbh Vorrichtung und Verfahren zur Aufbringung eines transkutanen elektrischen Stimulationsreizes auf die Oberfläche eines Abschnitts des menschlichen Ohrs

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107519573A (zh) * 2017-09-30 2017-12-29 武汉资联虹康科技股份有限公司 一种具有指示灯的耳夹电极
CN107582375A (zh) * 2017-09-30 2018-01-16 武汉资联虹康科技股份有限公司 一种具有光纤传导的耳夹电极

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DE102014015079A1 (de) 2016-04-14
DE102014015079B4 (de) 2016-08-25

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