EP2043737A1 - System for the transcutaneous stimulation of a nerve of the human body - Google Patents

System for the transcutaneous stimulation of a nerve of the human body

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Publication number
EP2043737A1
EP2043737A1 EP07765128A EP07765128A EP2043737A1 EP 2043737 A1 EP2043737 A1 EP 2043737A1 EP 07765128 A EP07765128 A EP 07765128A EP 07765128 A EP07765128 A EP 07765128A EP 2043737 A1 EP2043737 A1 EP 2043737A1
Authority
EP
European Patent Office
Prior art keywords
stimulation
electrode
nerve
connection
control element
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP07765128A
Other languages
German (de)
French (fr)
Inventor
Stefan Dietrich
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cerbomed GmbH
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 EP2043737A1 publication Critical patent/EP2043737A1/en
Withdrawn legal-status Critical Current

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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
    • A61N1/18—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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • 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
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile

Definitions

  • the invention relates to a system for transcutaneous stimulation of a nerve of the human body comprising a device having at least one stimulation electrode and at least one reference electrode for transcutaneous nerve stimulation, wherein the at least one stimulation electrode and the at least one reference electrode are in communication with a control unit and this can be acted upon by an electric current, wherein the at least one stimulation electrode and the at least one reference electrode are arranged in or on a housing which is designed for attachment to, in or behind the human ear.
  • a transcutaneously operating nerve stimulation device of the aforementioned type is known, for example, from DE 10 2005 003 735 A1.
  • the stimulation parameters must be set on the device itself, which results in an increased space requirement for electrical components. This is usually done via small potentiometers, which are brought with a miniature screwdriver in the desired position.
  • Carriers of such devices in particular for the treatment of depression, are interested in a most inconspicuous and small design, since this avoids a certain stigmatization effect.
  • the invention is therefore based on the invention, a system of the type mentioned in such a way that this desire is satisfied.
  • a system for transcutaneous nerve stimulation is to be created, which makes it possible to connect a stimulation device carried on, in or behind the ear to a programming unit by means of a wired or wireless connection. Via the connection, a wide variety of stimulation parameters, for example in the form of stimulation algorithms, can be transmitted. Furthermore, data should also be able to be read from a storage medium in the stimulation device.
  • the system mentioned above is characterized in that the system further comprises a programming device, with the course of at least one stimulation parameter for the nerve stimulation is definable, wherein the device further comprises a programmable control having a memory element which is connected to the control unit of the device and in which a program can be stored, which comprises the course of at least one stimulation parameter, wherein at least one temporary communication connection between the programming device and the control element for the transmission of information, in particular of data for the stimulation parameters, between the programming device and the control element can be produced.
  • the base device is designed for nerve stimulation, in particular for stimulating the vagus nerve in the region of the external auditory canal and / or the auricle.
  • the device is preferably constructed so that the housing has a bow-shaped extension which is used for positioning an electrode head in the region of the external auditory canal and / or
  • Auricle is formed.
  • the bow-shaped extension can be modeled on the shape of the external auditory canal and / or the auricle.
  • An object of the invention set forth here is the possibility of generating, on the part of the stimulation device, a wide variety of stimulation parameters, such as the frequency, the pulse width, the pulse duration or the amplitude.
  • the device has a programmable memory element which is used either as a stand-alone component z.
  • B. may be in the form of a flash or RAM or is shown as an integrated region on a microprocessor.
  • There algorithms are stored, which map the different settings of the stimulation parameters and via various other circuits, eg. B. causes a pulse generator, a supply of current to the stimulation electrode.
  • On such a memory in addition to information and algorithms for the stimulation parameters and other data, such.
  • an external programming device For programming, an external programming device is proposed with which the course of at least one stimulation parameter can be defined.
  • a further development provides for this purpose to use a commercially available PC on which a software for parameter and data definition is installed.
  • the programmer can also consist of its own housing with display and controls.
  • connection can be a wireless (eg BlueTooth, IR, DECT, ZigBee) or wired (eg USB) connection type.
  • wireless eg BlueTooth, IR, DECT, ZigBee
  • wired eg USB
  • a further development provides that the parameters set by a person with authorization (eg by a doctor) can no longer be changed by the wearer of the device, ie by the patient.
  • the attending physician gives the patient the option of setting at least one stimulation parameter as desired or in a specific value range himself. This can be done for example by means of a rotary knob or a multi-function switch.
  • the stimulation device is provided to equip the stimulation device with a clock (real-time clock or timer).
  • a clock real-time clock or timer
  • the device is also in addition to the skin power source, for example in the form of a rechargeable battery equipped with at least one auxiliary power source.
  • a refinement provides for a charging station belonging to the stimulation device for recharging the integrated accumulator so that, on the one hand, a charging of the current source on the other hand enables a data exchange between the stimulation device and the programmer via contact elements. This data exchange can be accomplished for example by electrical contact elements or else by optical (eg infrared), acoustic (eg Bluetooth) or other media.
  • the charging station, programming unit and stimulation device are preferably coordinated with one another via specific circuits in such a way that no stimulation current can be applied to the stimulation electrode of the stimulation device during data transmission or charging, thereby achieving high patient safety.
  • Fig. 1 shows schematically the circuit of a stimulation device for transcutaneous stimulation of the vagus nerve and the connection with a programming device and
  • Fig. 2 shows schematically the stimulation device, designed as a BTE (behind-the-ear) device, which is located in a charging station.
  • BTE behind-the-ear
  • Fig. 1 the circuit diagram of a system 1 for transcutaneous stimulation of a nerve is shown.
  • the auricular spaceus of the vagus nerve is stimulated to influence psycho-vegetative parameters. hereby For example, it can reduce physical and emotional stress, or it can have a positive effect on depression or other neuropsychiatric disorders.
  • the device 2 for transcutaneous stimulation of the vagus nerve consists essentially of a programmable control with stimulation circuit 8, a memory element 9, an electronic clock 12, a control unit 5, a first power supply (eg battery / accumulator) 13 for supplying the main circuit, a second power source (battery / accumulator) 14 as an auxiliary power supply, at least one adjusting means 15 and a stimulation electrode 3 and a reference electrode 4.
  • the components of the device 2 are housed in a housing 6.
  • the device 2 can be connected to a programming device 7 via a communication link 10 consisting of the communication devices 10 'and 10 "
  • the programming device has a PC 24 and a data input device 11 (keyboard).
  • the one part 10 "of the communication link 10 is located in the housing 6 of the device 2, the other part 10 'is connected to the PC 24.
  • FIG. 2 schematically shows the device 2 for transcutaneous nerve stimulation in a charging station 16.
  • the housing 6 of the device 2 is inserted into the charging station 16. There it can be connected via various contact elements 18 connection with z.
  • means 17 for inhibiting a stimulation current as long as the device 2 is located in the charging station 16. These means 17 prevent current from being applied to contact points 21 or 22.
  • the contact points 21, 22 are arranged in an electrode head 20, which in turn is arranged at the end of a bow-shaped extension 19.
  • a sensor 23 may be accommodated in the electrode head 20.
  • the proposed system 1 enables a particularly advantageous mode of operation of the device 2 for transcutaneous stimulation of the vagus nerve:
  • the doctor who has the programming device 9, can make contact with the device 2 via the communication connection 10 and, for example, transmit data for the treatment from the programming device 9 to the device 2 and, in particular, to the memory element 9.
  • These are in particular the above-mentioned parameters I, U, t and f.
  • the individual parameters can be given information whether and, if so, to what extent the patient himself can change the parameters by adjusting the device 2.
  • Parameter-specific value ranges can be defined for this, within which the patient himself can make a setting.
  • Other parameters may be from the Adjustment by the patient should be excluded if this is not recommended for the treatment.

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

Abstract

The invention relates to a system (1) for the transcutaneous stimulation of a nerve of the human body. Said system comprises a device (2) having at least one stimulation electrode (3) and at least one reference electrode (4) for transcutaneous nerve stimulation. The at least one stimulation electrode (3) and the at least one reference electrode (4) are connected to a control unit (5) and can be supplied by the latter with an electric current. The at least one stimulation electrode (3) and the at least one reference electrode (4) are arranged in or on a housing (6) that is adapted to be fastened on, in or behind the human ear. In order to increase functionality, the system (1) also comprises a programming device (7) which can be used to define the profile of at least one stimulation parameter (I, U, t, f) for the nerve stimulation. Said device (7) comprises a programmable control element (8) having a memory element (9) which is connected to the control unit (5) of the device (2) and in which a program can be stored that comprises the profile of at least one stimulation parameter (I, U, t, f), at least one temporary communication link (10, 10', 10'') for transmitting information, especially data for the stimulation parameters (I, U, t, f,), being establishable between the programming device (7) and the control element (8).

Description

System zur transkutanen Stimulation eines Nervs System for transcutaneous stimulation of a nerve
des menschlichen Körpersof the human body
Die Erfindung betrifft ein System zur transkutanen Stimulation eines Nervs des menschlichen Körpers, das eine Vorrichtung umfasst, die mindestens eine Stimulationselektrode und mindestens eine Referenzelektrode zur transkutanen Nervenstimulation aufweist, wobei die mindestens eine Stimulationselektrode und die mindestens eine Referenzelektrode mit einer Steuereinheit in Verbindung stehen und von dieser mit einem elektrischen Strom beaufschlagt werden können, wobei die mindestens eine Stimulationselektrode und die mindestens eine Referenzelektrode in oder an einem Gehäuse angeordnet sind, das zur Anbringung am, im oder hinter dem menschlichen Ohr ausgebildet ist.The invention relates to a system for transcutaneous stimulation of a nerve of the human body comprising a device having at least one stimulation electrode and at least one reference electrode for transcutaneous nerve stimulation, wherein the at least one stimulation electrode and the at least one reference electrode are in communication with a control unit and this can be acted upon by an electric current, wherein the at least one stimulation electrode and the at least one reference electrode are arranged in or on a housing which is designed for attachment to, in or behind the human ear.
Es ist generell bekannt, durch invasive und non-invasive Reizung der Nerven Einfluss auf deren neurophysiologische und neuroelektrische Qualität und damit auf die Funktion der stimulierten Nerven zu nehmen. Hierdurch können verschiedene Krankheitszustände behandelt werden. Es existieren zahlreiche Vorrichtungen sowohl zu invasiven als auch zu non-invasiven Stimulation. Ausgangsbasis der hier dargelegten Erfindung ist die Methode der transkutanen elektrischen Nervenstimulation. Bei diesem Verfahren werden Impulsströme verschiedener Stromformen, Amplituden, Impulsdauern und Frequenzen durch die Haut hindurch an verschiedenen Nerven appliziert und verändern deren Statusparameter in vorteilhafter Weise.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 basis of the invention presented here is the method of transcutaneous electrical nerve stimulation. In this method, pulse currents of different current forms, amplitudes, pulse durations and Frequencies through the skin applied to different nerves and change their status parameters in an advantageous manner.
Eine transkutan arbeitende Nerven-Stimulationsvorrichtung der eingangs genannten Art ist beispielsweise aus der DE 10 2005 003 735 Al bekannt.A transcutaneously operating nerve stimulation device of the aforementioned type is known, for example, from DE 10 2005 003 735 A1.
Bei den bisher bekannten Lösungen haben sich folgende Umstände als nachteilig erwiesen:In the previously known solutions, the following circumstances have proven disadvantageous:
Die Stimulationsparameter müssen am Gerät selbst eingestellt werden, was einen erhöhten Platzbedarf für elektrische Bauelemente zur Folge hat. Die geschieht meist über kleine Potentiometer, welche mit einem Miniaturschraubendreher in die gewünschte Position gebracht werden.The stimulation parameters must be set on the device itself, which results in an increased space requirement for electrical components. This is usually done via small potentiometers, which are brought with a miniature screwdriver in the desired position.
Hierdurch wird eine solche Vorrichtung größer und verliert an Tragekomfort. Träger solcher Vorrichtungen, insbesondere zur Behandlung von Depressionen, sind an einer möglichst unauffälligen und kleinen Bauform interessiert, da hierdurch ein gewisser Stigmatisierungseffekt vermieden wird.As a result, such a device becomes larger and loses comfort. Carriers of such devices, in particular for the treatment of depression, are interested in a most inconspicuous and small design, since this avoids a certain stigmatization effect.
Es ist nicht möglich, die Parametereinstellungen absolut zu fixieren.It is not possible to fix the parameter settings absolutely.
Hierdurch kann es zu ungewünschten Einstellungsveränderungen zu Lasten des therapeutischen Nutzens des Gerätes kommen. Zudem wird dem Patienten bzw. Träger der Vorrichtung die Möglichkeit gegeben, eigenständig Einstellungs Veränderungen vorzunehmen, was aus therapeutischer Sicht oft nicht gewünscht ist.This can lead to unwanted changes in attitude at the expense of the therapeutic benefits of the device. In addition, the patient or wearer of the device is given the opportunity to independently make adjustments changes, which is often not desired from a therapeutic point of view.
Es wurde festgestellt, dass das Fehlen eines Speicherelements und einer entsprechenden Verbindung zu einem Programmiergerät es unmöglich macht, Daten über die Stimulationsparameter, Daten über die Stimulation (z. B. Dauer, Zeit, Datum) oder Produktinformationen auf dem Gerät zu speichern und diese bei Bedarf auszulesen oder zu verändern.It has been found that the lack of a memory element and corresponding connection to a programmer makes it impossible to obtain data about the stimulation parameters, data on the stimulation (e.g. Duration, time, date) or to store product information on the device and to read or modify it as needed.
Für einen großflächigen therapeutischen Einsatz der Methode ist es wünschenswert, ein System zu entwickeln, dass diesen Anforderungen Rechnung trägt.For a large-scale therapeutic use of the method, it is desirable to develop a system that meets these requirements.
Der Erfindung liegt daher die A u f g a b e zugrunde, ein System der eingangs genannten Art so weiterzubilden, dass dieser Wunsch befriedigt wird. Es soll ein System zur transkutanen Nervenstimulation geschaffen werden, welches es möglich macht, eine am, im oder hinter dem Ohr getragene Stimulationsvorrichtung mittels einer drahtgebundenen oder drahtlosen Verbindung mit einer Programmiereinheit zu verbinden. Über die Verbindung sollen verschiedenste Stimulationsparameter, beispielsweise in Form von Stimulationsalgorithmen, gesendet werden können. Ferner sollen auch Daten von einem Speichermedium in der Stimulationsvorrichtung ausgelesen werden können.The invention is therefore based on the invention, a system of the type mentioned in such a way that this desire is satisfied. A system for transcutaneous nerve stimulation is to be created, which makes it possible to connect a stimulation device carried on, in or behind the ear to a programming unit by means of a wired or wireless connection. Via the connection, a wide variety of stimulation parameters, for example in the form of stimulation algorithms, can be transmitted. Furthermore, data should also be able to be read from a storage medium in the stimulation device.
Die L ö s u n g dieser Aufgabe durch die Erfindung ist dadurch gekennzeichnet, dass das eingangs genannte System sich dadurch auszeichnet, dass das System weiterhin ein Programmiergerät aufweist, mit dem der Verlauf mindestens eines Stimulationsparameters für die Nervenstimulation definierbar ist, wobei die Vorrichtung weiterhin ein programmierbares Steuerelement mit einem Speicherelement aufweist, das mit der Steuereinheit der Vorrichtung in Verbindung steht und in dem ein Programm speicherbar ist, das den Verlauf mindestens eines Stimulationsparameters umfasst, wobei zwischen dem Programmiergerät und dem Steuerelement zumindest eine temporäre Kommunikationsverbindung zur Übertragung von Informationen, insbesondere von Daten für die Stimulationsparameters, zwischen dem Programmiergerät und dem Steuerelement herstellbar ist.The solution to this problem by the invention is characterized in that the system mentioned above is characterized in that the system further comprises a programming device, with the course of at least one stimulation parameter for the nerve stimulation is definable, wherein the device further comprises a programmable control having a memory element which is connected to the control unit of the device and in which a program can be stored, which comprises the course of at least one stimulation parameter, wherein at least one temporary communication connection between the programming device and the control element for the transmission of information, in particular of data for the stimulation parameters, between the programming device and the control element can be produced.
Dabei ist die Basisvorrichtung zur Nervenstimulation insbesondere zur Stimulation des Nervus vagus im Bereich des äußeren Gehörgangs und/oder der Ohrmuschel ausgebildet. Zur optimalen Positionierung der mindestens einen Stimulationselektrode und der mindestens einen Referenzelektrode ist die Vorrichtung vorzugsweise so konstruiert, dass das Gehäuse einen bügeiförmigen Fortsatz aufweist, der zur Positionierung eines Elektrodenkopfes im Bereich des äußeren Gehörgangs und/oder derIn this case, the base device is designed for nerve stimulation, in particular for stimulating the vagus nerve in the region of the external auditory canal and / or the auricle. For optimum positioning of the at least one stimulation electrode and the at least one reference electrode, the device is preferably constructed so that the housing has a bow-shaped extension which is used for positioning an electrode head in the region of the external auditory canal and / or
Ohrmuschel ausgebildet ist. Der bügelförmige Fortsatz kann der Form des äußeren Gehörgangs und/oder der Ohrmuschel nachgebildet sein.Auricle is formed. The bow-shaped extension can be modeled on the shape of the external auditory canal and / or the auricle.
Ein Gegenstand der hier dargelegten Erfindung ist die Möglichkeit, seitens der Stimulationsvorrichtung verschiedenste Stimulationsparameter wie beispielsweise die Frequenz, die Impulsbreite, die Impulsdauer oder Amplitude zu generieren. Hierzu weist die Vorrichtung ein programmierbares Speicherelement auf, welches entweder als stand-alone Komponente z. B. in Form eines Flash oder RAMs ausgebildet sein kann oder als integrierte Region auf einem Mikroprozessor dargestellt ist. Dort werden Algorithmen abgelegt, welche die verschiedenen Einstellungen der Stimulationsparameter abbilden und über verschiedene weitere Schaltkreise, z. B. einen Impulsgenerator, ein Beaufschlagen von Strom an der Stimulationselektrode veranlasst. Auf einem solchen Speicher können neben Informationen und Algorithmen zu den Stimulationsparametern auch weitere Daten, wie z. B. Patientendaten oder Informationen aus mindestens einem Sensor, welcher in die Vorrichtung integriert ist, abgelegt werden. Zur Programmierung wird ein externes Programmiergerät vorgeschlagen, mit dem der Verlauf mindestens eines Stimulationsparameters definierbar ist. Eine Weiterbildung sieht vor, hierfür einen handelsüblichen PC zu verwenden, auf dem eine Software zur Parameter- und Datendefinition installiert ist. Das Programmiergerät kann auch aus einem eigenen Gehäuse mit Display und Steuerelementen bestehen.An object of the invention set forth here is the possibility of generating, on the part of the stimulation device, a wide variety of stimulation parameters, such as the frequency, the pulse width, the pulse duration or the amplitude. For this purpose, the device has a programmable memory element which is used either as a stand-alone component z. B. may be in the form of a flash or RAM or is shown as an integrated region on a microprocessor. There algorithms are stored, which map the different settings of the stimulation parameters and via various other circuits, eg. B. causes a pulse generator, a supply of current to the stimulation electrode. On such a memory, in addition to information and algorithms for the stimulation parameters and other data, such. B. patient data or information from at least one sensor, which is integrated into the device, are stored. For programming, an external programming device is proposed with which the course of at least one stimulation parameter can be defined. A further development provides for this purpose to use a commercially available PC on which a software for parameter and data definition is installed. The programmer can also consist of its own housing with display and controls.
Zwischen dem Programmiergerät und der Stimulationsvorrichtung besteht zumindest temporär eine Verbindung, um einen Informationsaustausch herüber und hinüber zu gewährleisten. Bei der Verbindung kann es sich um eine drahtlose (z. B. BlueTooth, IR, DECT, ZigBee) oder drahtgebundene (z. B. USB) Verbindungsart handeln.There is at least a temporary connection between the programming device and the stimulation device in order to ensure an exchange of information over and over. The connection can be a wireless (eg BlueTooth, IR, DECT, ZigBee) or wired (eg USB) connection type.
Eine Weiterbildung sieht vor, dass die von einer Person mit Berechtigung eingestellten Parameter (z. B. von einem Arzt) nicht mehr vom Träger der Vorrichtung, also vom Patienten, geändert werden können. Es kann aber auch vorgesehen sein, dass der behandelnde Arzt dem Patienten die Möglichkeit gibt, mindestens einen Stimulationsparameter beliebig oder in einem bestimmten Wertebereich selbst einzustellen. Dies kann beispielsweise mittels eines Drehrädchens oder eines Multifunktionsschalters geschehen.A further development provides that the parameters set by a person with authorization (eg by a doctor) can no longer be changed by the wearer of the device, ie by the patient. However, it can also be provided that the attending physician gives the patient the option of setting at least one stimulation parameter as desired or in a specific value range himself. This can be done for example by means of a rotary knob or a multi-function switch.
Um es z. B. einem Arzt möglich zu machen, im Nachhinein Informationen zum Stimulationsvorgang zu erhalten, ist vorgesehen, die Stimulationsvorrichtung mit einer Uhr (Real-Time-Clock oder Timer) auszustatten. In Kombination mit anderen Bauelementen, z. B. einem Mikroprozessor oder einem Flash, kann so eine Tragekontrolle ermöglicht werden. Hierzu ist das Gerät zudem neben der Hautstromquelle beispielsweise in Form eines wieder aufladbaren Akkumulators mit mindestens einer Hilfsstromquelle ausgestattet. Eine Weiterbildung sieht vor, eine zur Stimulationsvorrichtung gehörende Ladestation zum Wiederaufladen des integrierten Akkumulators so weiterzubilden, dass über Kontaktelemente einerseits ein Aufladen der Stromquelle andererseits ein Datenaustausch zwischen Stimulationsvorrichtung und Programmiergerät ermöglicht wird. Dieser Datenaustausch kann beispielsweise durch elektrische Kontaktelemente oder aber durch optische (z. B. Infrarot), akustische (z. B. Bluetooth) oder andere Medien bewerkstelligt werden.To z. As a doctor to make it possible to obtain information on the stimulation process in retrospect, it is provided to equip the stimulation device with a clock (real-time clock or timer). In combination with other components, eg. As a microprocessor or a flash, so a wearing control can be enabled. For this purpose, the device is also in addition to the skin power source, for example in the form of a rechargeable battery equipped with at least one auxiliary power source. A refinement provides for a charging station belonging to the stimulation device for recharging the integrated accumulator so that, on the one hand, a charging of the current source on the other hand enables a data exchange between the stimulation device and the programmer via contact elements. This data exchange can be accomplished for example by electrical contact elements or else by optical (eg infrared), acoustic (eg Bluetooth) or other media.
Vorzugsweise sind Ladestation, Programmiereinheit und Stimulationsgerät über bestimmte Schaltkreise so aufeinander abgestimmt, dass während einer Datenübertragung oder des Ladevorgangs kein Stimulationsstrom auf die Stimulationselektrode der Stimulationsvorrichtung beaufschlagt werden kann, wodurch eine hohe Patientensicherheit erreicht wird.The charging station, programming unit and stimulation device are preferably coordinated with one another via specific circuits in such a way that no stimulation current can be applied to the stimulation electrode of the stimulation device during data transmission or charging, thereby achieving high patient safety.
In der Zeichnung ist ein Ausführungsbeispiel der Erfindung dargestellt. Es zeigen:In the drawing, an embodiment of the invention is shown. Show it:
Fig. 1 schematisch den Schaltkreis einer Stimulationsvorrichtung zur transkutanen Stimulation des Vagusnervs und die Verbindung mit einem Programmiergerät undFig. 1 shows schematically the circuit of a stimulation device for transcutaneous stimulation of the vagus nerve and the connection with a programming device and
Fig. 2 schematisch das Stimulationsgerät, ausgebildet als HdO-(Hinter- dem-Ohr)-Gerät, das sich in einer Ladestation befindet.Fig. 2 shows schematically the stimulation device, designed as a BTE (behind-the-ear) device, which is located in a charging station.
In Fig. 1 ist das Schaltbild eines Systems 1 zur transkutanen Stimulation eines Nervs gezeigt. Stimuliert wird insbesondere der Raumus auricularis des Nervus vagus zur Einflussnahme auf psycho vegetative Parameter. Hierdurch kann beispielsweise der Abbau von körperlichem und seelischem Stress erfolgen oder es kann positiv auf Depressionen oder andere neuro- psychiatrische Störungen Einfluss genommen werden.In Fig. 1, the circuit diagram of a system 1 for transcutaneous stimulation of a nerve is shown. In particular, the auricular spaceus of the vagus nerve is stimulated to influence psycho-vegetative parameters. hereby For example, it can reduce physical and emotional stress, or it can have a positive effect on depression or other neuropsychiatric disorders.
Die Vorrichtung 2 zur transkutanen Stimulation des Vagusnervs besteht im wesentlichen aus einem programmierbaren Steuerelement mit Stimulationsschaltkreis 8, einem Speicherelement 9, einer elektronischen Uhr 12, einer Steuereinheit 5, einer ersten Stromversorgung (z. B. Batterie/ Akkumulator) 13 zur Versorgung des Hauptstromkreises, einer zweiten Stromquelle (Batterie/ Akkumulator) 14 als HilfsStromversorgung, mindestens einem Einstellmittel 15 und einer Stimulationselektrode 3 und einer Referenzelektrode 4. Die Komponenten der Vorrichtung 2 sind in einem Gehäuse 6 untergebracht.The device 2 for transcutaneous stimulation of the vagus nerve consists essentially of a programmable control with stimulation circuit 8, a memory element 9, an electronic clock 12, a control unit 5, a first power supply (eg battery / accumulator) 13 for supplying the main circuit, a second power source (battery / accumulator) 14 as an auxiliary power supply, at least one adjusting means 15 and a stimulation electrode 3 and a reference electrode 4. The components of the device 2 are housed in a housing 6.
Die Vorrichtung 2 kann über eine Kommunikationsverbindung 10, bestehend aus den Kommunikationsbausteinen 10' und 10", mit einem Programmiergerät 7 verbunden werden. Das Programmiergerät weist einen PC 24 sowie eine Dateneingabevorrichtung 11 (Tastatur) auf.The device 2 can be connected to a programming device 7 via a communication link 10 consisting of the communication devices 10 'and 10 "The programming device has a PC 24 and a data input device 11 (keyboard).
Der eine Teil 10" der Kommunikationsverbindung 10 befindet sich in dem Gehäuse 6 der Vorrichtung 2, der andere Teil 10' ist mit dem PC 24 verbunden.The one part 10 "of the communication link 10 is located in the housing 6 of the device 2, the other part 10 'is connected to the PC 24.
Über die Kommunikationsverbindung 10 können verschiedene Stimulations- Parameter, wie Stromstärke (I), Spannung (U), Zeitdauer (t) und Frequenz (f), auf die Vorrichtung 2 und namentlich auf deren Speicherelement 9 aufgespielt werden oder Daten von der Vorrichtung 2 abgerufen werden. Fig. 2 zeigt schematisch die Vorrichtung 2 zur transkutanen Nervenstimulation in einer Ladestation 16. Das Gehäuse 6 der Vorrichtung 2 wird in die Ladestation 16 eingesteckt. Dort kann es über verschiedene Kontaktelemente 18 Verbindung mit z. B. einer Kommunikationsverbindung 10" erhalten. Vorgesehen sind weiterhin Mittel 17 zur Unterbindung eines Stimulationsstroms, solange sich die Vorrichtung 2 in der Ladestation 16 befindet. Diese Mittel 17 unterbinden ein Beaufschlagen von Kontaktstellen 21 bzw. 22 mit Strom. Die Kontaktstellen 21 , 22 sind in einem Elektrodenkopf 20 angeordnet, der wiederum am Ende eines bügeiförmigen Fortsatzes 19 angeordnet ist.Via the communication link 10, various stimulation parameters, such as current intensity (I), voltage (U), time duration (t) and frequency (f), can be applied to the device 2 and, in particular, to its memory element 9 or data can be retrieved from the device 2 become. FIG. 2 schematically shows the device 2 for transcutaneous nerve stimulation in a charging station 16. The housing 6 of the device 2 is inserted into the charging station 16. There it can be connected via various contact elements 18 connection with z. Also provided are means 17 for inhibiting a stimulation current as long as the device 2 is located in the charging station 16. These means 17 prevent current from being applied to contact points 21 or 22. The contact points 21, 22 are arranged in an electrode head 20, which in turn is arranged at the end of a bow-shaped extension 19.
Zudem kann - wie im Ausfuhrungsbeispiel zu sehen - im Elektrodenkopf 20 ein Sensor 23 untergebracht sein.In addition, as shown in the exemplary embodiment, a sensor 23 may be accommodated in the electrode head 20.
Das vorgeschlagene System 1 ermöglicht eine besonders vorteilhafte Betriebsweise der Vorrichtung 2 zur transkutanen Stimulation des Vagusnervs:The proposed system 1 enables a particularly advantageous mode of operation of the device 2 for transcutaneous stimulation of the vagus nerve:
Der Arzt, der über das Programmiergerät 9 verfugt, kann über die Kommunikationsverbindung 10 mit der Vorrichtung 2 Kontakt aufnehmen und beispielsweise Daten für die Behandlung vom Programmiergerät 9 in die Vorrichtung 2 und namentlich in das Speicherelement 9 übertragen. Dabei handelt es sich namentlich um die oben genannten Parameter I, U, t und f.The doctor, who has the programming device 9, can make contact with the device 2 via the communication connection 10 and, for example, transmit data for the treatment from the programming device 9 to the device 2 and, in particular, to the memory element 9. These are in particular the above-mentioned parameters I, U, t and f.
Dabei können den einzelnen Parametern Informationen mitgegeben werden, ob und falls ja, inwieweit der Patient selber durch Einstellung an der Vorrichtung 2 die Parameter ändern kann. Hierfür können parameterspezifisch Wertebereiche definiert werden, innerhalb derer der Patient selber eine Einstellung vornehmen kann. Andere Parameter können von der Einstellbarkeit durch den Patienten ausgenommen werden, wenn dies für die Behandlung nicht empfehlenswert ist. In this case, the individual parameters can be given information whether and, if so, to what extent the patient himself can change the parameters by adjusting the device 2. Parameter-specific value ranges can be defined for this, within which the patient himself can make a setting. Other parameters may be from the Adjustment by the patient should be excluded if this is not recommended for the treatment.
Bezugszeichenliste:LIST OF REFERENCE NUMBERS
1 System zur transkutanen Stimulation eines Nervs1 system for transcutaneous stimulation of a nerve
2 Vorrichtung 3 Stimulationselektrode2 device 3 stimulation electrode
4 Referenzelektrode4 reference electrode
5 Steuereinheit5 control unit
6 Gehäuse6 housing
7 Programmiergerät 8 programmierbares Steuerelement mit Stimulationsschaltkreis7 Programmer 8 programmable control with pacing circuitry
9 Speicherelement9 storage element
10 Kommunikationsverbindung10 communication connection
10' Kommunikationsverbindung10 'communication connection
10" Kommunikationsverbindung 1 1 Dateneingabevorrichtung10 "communication link 1 1 data input device
12 elektronische Uhr12 electronic clock
13 erste Batterie13 first battery
14 zweite Batterie14 second battery
15 Einstellmittel 16 Ladestation15 Adjustment 16 Charging station
17 Mittel zur Unterbindung eines Stimulationsstroms17 means for stopping a stimulation current
18 Kontaktelement18 contact element
19 bügeiförmiger Fortsatz19 bow-shaped extension
20 Elektrodenkopf 21 Kontaktstelle20 electrode head 21 contact point
22 Kontaktstelle22 contact point
23 Sensor23 sensor
24 PC24 pcs
I, U, t, f StimulationsparameterI, U, t, f stimulation parameters
I StromI electricity
U Spannung t Zeitdauer f Frequenz U voltage t duration f frequency

Claims

Patentansprüche: claims:
1. System (1) zur transkutanen Stimulation eines Nervs des menschlichen Körpers, das eine Vorrichtung (2) umfasst, die mindestens eine Stimulationselektrode (3) und mindestens eine Referenzelektrode (4) zur transkutanen Nervenstimulation aufweist, wobei die mindestens eineA system (1) for transcutaneous stimulation of a nerve of the human body comprising a device (2) comprising at least one stimulation electrode (3) and at least one reference electrode (4) for transcutaneous nerve stimulation, the at least one
Stimulationselektrode (3) und die mindestens eine Referenzelektrode (4) mit einer Steuereinheit (5) in Verbindung stehen und von dieser mit einem elektrischen Strom beaufschlagt werden können, wobei die mindestens eine Stimulationselektrode (3) und die mindestens eine Referenzelektrode (4) in oder an einem Gehäuse (6) angeordnet sind, das zur Anbringung am, im oder hinter dem menschlichen Ohr ausgebildet ist,Stimulation electrode (3) and the at least one reference electrode (4) with a control unit (5) are connected and can be acted upon by this with an electric current, wherein the at least one stimulation electrode (3) and the at least one reference electrode (4) in or arranged on a housing (6), which is designed for attachment to, in or behind the human ear,
dadurch gekennzeichnet,characterized,
dass das System (1) weiterhin ein Programmiergerät (7) aufweist, mit dem der Verlauf mindestens eines Stimulationsparameters (I, U, t, f) für die Nervenstimulation definierbar ist,the system (1) furthermore has a programming device (7) with which the course of at least one stimulation parameter (I, U, t, f) can be defined for the nerve stimulation,
wobei die Vorrichtung (2) weiterhin ein programmierbaresthe device (2) further comprising a programmable
Steuerelement (8) mit einem Speicherelement (9) aufweist, das mit der Steuereinheit (5) der Vorrichtung (2) in Verbindung steht und in dem ein Programm speicherbar ist, das den Verlauf mindestens eines Stimulationsparameters (I, U, t, f) umfasst, wobei zwischen dem Programmiergerät (7) und dem Steuerelement (8) zumindest eine temporäre Kommunikationsverbindung (10, 10', 10") zur Übertragung von Informationen, insbesondere von Daten für die Stimulationsparameters (I, U, t, f), zwischen dem Programmiergerät (7) und dem Steuerelement (8) herstellbar ist.Having a control element (8) with a memory element (9) which is connected to the control unit (5) of the device (2) and in which a program can be stored which stores the course of at least one stimulation parameter (I, U, t, f) includes, wherein between the programming device (7) and the control element (8) at least one temporary communication link (10, 10 ', 10 ") for transmitting information, in particular data for the stimulation parameters (I, U, t, f), between the programmer (7) and the control element (8) can be produced.
2. System nach Anspruch 1, dadurch gekennzeichnet, dass das2. System according to claim 1, characterized in that the
Programmiergerät (7), die Kommunikations Verbindung (10, 10', 10") und das Steuerelement (8) so ausgebildet sind, dass alle relevanten Stimulationsparameters (I, U, t, f) für die Stimulation eines Nervs vom Programmiergerät (7) auf das Steuerelement (8) übertragbar sind.Programming device (7), the communication link (10, 10 ', 10 ") and the control element (8) are designed so that all relevant stimulation parameters (I, U, t, f) for the stimulation of a nerve from the programming device (7) on the control element (8) are transferable.
3. System nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass die3. System according to claim 1 or 2, characterized in that the
Vorrichtung (2) weiterhin Einstellmittel (15) aufweist, mit denen ein definierter Teil der Stimulationsparameters (I, U, t, f) insbesondere von der die Vorrichtung (2) tragenden Person beeinflusst werden kann.Device (2) further comprises adjusting means (15) with which a defined part of the stimulation parameters (I, U, t, f) can be influenced in particular by the person carrying the device (2).
4. System nach Anspruch 3, dadurch gekennzeichnet, dass die4. System according to claim 3, characterized in that the
Einstellmittel (15) so ausgebildet sind, dass die mit den Einstellmitteln (15) beeinflussbaren Stimulationsparameter (I, U, t, f) nur in vorgegebenen Wertebereichen beeinflussbar sind. Setting means (15) are formed so that the stimulation parameters (I, U, t, f) which can be influenced by the adjusting means (15) can be influenced only in predetermined value ranges.
5. System nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass die Steuereinheit (5), das Steuerelement (8) und das Speicherelement (9) so ausgelegt sind, dass auf dem Speicherelement (9) die dem Benutzer der Vorrichtung (2) aufgegebene Stimulationsparameter (I, U, t, f) gespeichert werden können.5. System according to any one of claims 1 to 4, characterized in that the control unit (5), the control element (8) and the storage element (9) are designed so that on the storage element (9) to the user of the device (2 ) paced stimulation parameters (I, U, t, f) can be stored.
6. System nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass die Vorrichtung (2) weiterhin eine elektronische Uhr (12) umfasst, die mit dem Steuerelement (8) in Verbindung steht.6. System according to one of claims 1 to 5, characterized in that the device (2) further comprises an electronic clock (12) which is in communication with the control element (8).
7. System nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass die Kommunikationsverbindung (10, 10', 10") einen Verbindungsdraht umfasst, der zwischen dem Programmiergerät (7) und der Vorrichtung (2) angeordnet werden kann.7. System according to one of claims 1 to 6, characterized in that the communication link (10, 10 ', 10 ") comprises a connecting wire which can be arranged between the programming device (7) and the device (2).
8. System nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass die Kommunikationsverbindung (10, 10', 10") als drahtlose Verbindung ausgebildet ist. 8. System according to any one of claims 1 to 6, characterized in that the communication link (10, 10 ', 10 ") is designed as a wireless connection.
9. System nach Anspruch 8, dadurch gekennzeichnet, dass die drahtlose Verbindung eine Funkverbindung, insbesondere eine Blue-Tooth- Verbindung, eine WLAN- Verbindung, eine DECT- Verbindung oder eine ZigBee-Verbindung ist.9. System according to claim 8, characterized in that the wireless connection is a radio connection, in particular a blue-tooth connection, a WLAN connection, a DECT connection or a ZigBee connection.
10. System nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, dass das Programmiergerät (7) eine Dateneingabevorrichtung (11), insbe- sondere eine Tastatur, umfasst.10. System according to any one of claims 1 to 9, characterized in that the programming device (7) comprises a data input device (11), in particular a keyboard.
11. System nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, dass das Programmiergerät (7) einen PC (24) umfasst.11. System according to one of claims 1 to 10, characterized in that the programming device (7) comprises a PC (24).
12. System nach einem der Ansprüche 1 bis 11, dadurch gekennzeichnet, dass die Vorrichtung (2) weiterhin eine erste Batterie (13) zur12. System according to any one of claims 1 to 11, characterized in that the device (2) further comprises a first battery (13) for
Stromversorgung insbesondere der Steuereinheit (5) der Vorrichtung (2) aufweist.Power supply in particular the control unit (5) of the device (2).
13. System nach einem der Ansprüche 1 bis 12, dadurch gekennzeichnet, dass die Vorrichtung (2) weiterhin eine zweite Batterie (14) zur Stromversorgung insbesondere des Steuerelements (8) der Vorrichtung (2) aufweist. 13. System according to any one of claims 1 to 12, characterized in that the device (2) further comprises a second battery (14) for power supply in particular of the control element (8) of the device (2).
14. System nach Anspruch 12 oder 13, dadurch gekennzeichnet, dass es weiterhin eine Ladestation (16) zum Aufladen zumindest der ersten14. System according to claim 12 or 13, characterized in that it further comprises a charging station (16) for charging at least the first
Batterie (13) aufweist.Battery (13).
15. System nach Anspruch 14, dadurch gekennzeichnet, dass die15. System according to claim 14, characterized in that the
Vorrichtung (2) und/oder die Ladestation (16) mit Mitteln (17) versehen sind, die die Erzeugung eines Stimulationsstroms an den Elektroden (3, 4) der Vorrichtung (2) bei sich in der Ladestation (16) befindlicher Vorrichtung (2) unterbinden.Device (2) and / or the charging station (16) with means (17) are provided, the generation of a stimulation current to the electrodes (3, 4) of the device (2) in befindlicher in the charging station (16) device (2 ) stop.
16. System nach Anspruch 14 oder 15, dadurch gekennzeichnet, dass die Ladestation (16) ein Element (10") zur Herstellung der Kommunikationsverbindung aufweist, wobei Kontaktelemente (18) vorhanden sind, mit denen eine Verbindung zwischen der Vorrichtung (2) und dem Element (10") zur Herstellung der Kommunikationsverbindung bei sich in der Ladestation (16) befindlicher Vorrichtung (2) hergestellt wird.16. System according to claim 14 or 15, characterized in that the charging station (16) has an element (10 ") for producing the communication connection, wherein contact elements (18) are provided, with which a connection between the device (2) and the Element (10 ") for establishing the communication connection is in befindlicher in the charging station (16) device (2) is produced.
17. System nach einem der Ansprüche 1 bis 16, dadurch gekennzeichnet, dass die Vorrichtung (2) einen bügelförmigen Fortsatz (19) aufweist, der zur Einführung in den Gehörgang ausgebildet ist, wobei der bügeiförmige Fortsatz (19) der Form des Gehörgangeinganges bzw. des äußeren Gehörgangs nachgebildet ist und wobei am Ende des bügeiförmigen Fortsatzes (19) ein Elektrodenkopf (20) angeordnet ist, der zwei Kontaktstellen (21, 22) für die beiden Elektroden (3, 4) aufweist.17. System according to one of claims 1 to 16, characterized in that the device (2) has a bow-shaped extension (19), the is designed for insertion into the auditory canal, wherein the bow-shaped projection (19) of the shape of the auditory canal entrance or the external auditory canal is modeled and wherein at the end of the bow-shaped extension (19) an electrode head (20) is arranged, the two contact points (21, 22) for the two electrodes (3, 4).
18. System nach Anspruch 17, dadurch gekennzeichnet, dass der18. System according to claim 17, characterized in that the
Elektrodenkopf (19) zur Stimulation des Nervus vagus im Bereich des äußeren Gehörgangs und/oder der Ohrmuschel ausgebildet und geeignet ist.Electrode head (19) is designed and suitable for stimulating the vagus nerve in the region of the external auditory canal and / or the auricle.
19. System nach Anspruch 17 oder 18, dadurch gekennzeichnet, dass der Elektrodenkopf (19) aus einem weichen Material besteht, insbesondere aus weichbleibendem Silikon.19. System according to claim 17 or 18, characterized in that the electrode head (19) consists of a soft material, in particular made of soft silicone.
20. System nach einem der Ansprüche 1 bis 19, dadurch gekennzeichnet, dass die Vorrichtung (2) weiterhin mindestens einen Sensor (23) zur Messung eines physiologischen Parameters der die Vorrichtung benutzenden Person aufweist. 20. System according to any one of claims 1 to 19, characterized in that the device (2) further comprises at least one sensor (23) for measuring a physiological parameter of the person using the device.
EP07765128A 2006-07-18 2007-07-09 System for the transcutaneous stimulation of a nerve of the human body Withdrawn EP2043737A1 (en)

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RU2446841C2 (en) 2012-04-10
JP2009543621A (en) 2009-12-10
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WO2008009362A1 (en) 2008-01-24
US20080021520A1 (en) 2008-01-24
CN101489626A (en) 2009-07-22
KR20090040342A (en) 2009-04-23
CA2658565A1 (en) 2008-01-24
DE102006033623A1 (en) 2008-01-24
RU2009105493A (en) 2010-08-27

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