Device for performing a tVNS treatment

Abstract

The present invention relates to a device for performing a tVNS treatment having at least one electrode for generating a stimulation pulse, with the device having at least one detection means that is configured to detect one or more parameter values, and with the device having a control or regulation unit that is suitable to set one or more parameters of the stimulation pulse delivered by the electrode in dependence on the detected parameter value or values.

Claims

1. A device for performing a tVNS (transcutaneous vagus nerve stimulation) treatment having at least one electrode for generating a stimulation pulse, wherein the device has detection means configured to detect one or more parameter values, and a control or regulation unit configured to set one or more parameters of the stimulation pulse delivered by the electrode in dependence on the detected one or more parameter values, the detection means are configured to measure the one or more parameter values in real time, the control or regulation unit is configured to set the stimulation pulse in dependence on the one or more parameter values measured in real time, the detection means comprise pupillometry and/or skin conductivity sensors, the control or regulation unit is configured to influence sympathovagal balance based on tone detected by said sensors, the device comprises a closed loop to regulate the tone to a desired value or range, and the detection means comprise a breathing and/or movement sensor configured to detect and communicate periodic state of a sympathovagal system to the control or regulation unit which is configured to trigger the device in response to a breathing signal and/or a signal relating to the movement of the patient from the detection means.

2. A device in accordance with claim 1, wherein the control or regulation unit is configured to coordinate the stimulation pulses with periodically occurring physiological processes of the patient.

3. A device in accordance with claim 2, wherein the physiological processes are neurological processes.

4. A device in accordance with claim 1, wherein the electrode is an ear electrode.

5. A device in accordance with claim 4, wherein the electrode comprises a loudspeaker.

6. A device in accordance with claim 1, wherein the detection means comprise an EEG and/or ECG sensor.

7. A device in accordance with claim 1, wherein the measured one or more parameter values are added to an inflexible stimulation routine.

8. A device in accordance with claim 1, wherein the one or more parameter values are not stored in the device when measured in real time.

Description

DESCRIPTION OF THE PREFERRED EMBODIMENTS

(1) Preferred features of the method can be found in the description herein.

(2) It is pointed out at this point that the terms a and one do not necessarily refer to exactly one of the elements, even though this represents a possible embodiment, but can also designate a plurality of elements. The use of the plural equally also includes the presence of the element in question in the singular and, conversely, the singular also includes a plurality of the elements in question.

(3) Further details and advantages of the invention will be explained in more detail with reference to an embodiment described in the following.

(4) The embodiment relates to a device for performing a tVNS treatment that has one or more electrodes, preferably ear electrodes, for delivering stimulation pulses.

(5) The vagus stimulation is based on a branch of the vagus nerve in the form of the Ramus auricularis nervi vagi (RANV) sensitively supplying the skin of the auricle in the region of the concha.

(6) The RANV can be stimulated transcutaneously, that is through the skin, with electrical pulses by means of the electrode. The stimulation of the RANV causes an excitation of the vagus nerve that, as in conventional (non-transcutaneous) VNS, enters into the more highly disposed centers of the brain via the brainstem.

(7) The device generates electrical pulses and can have the size of a smartphone.

(8) One or two ear electrodes can be used. The electrodes deliver the pulses through the skin to the branch of the vagus nerve. The ear electrodes can be configured such that they have loudspeakers so that the patient can hear music or the like during the treatment.

(9) Unlike a known device for performing a tVNS, the device in accordance with the invention is a device for adaptive tVNS, i.e. a device whose stimulation protocol is not always identical, but rather depends on one or more parameters specific to the patient and/or one or more parameters not specific to the patient.

(10) The basic idea of the present invention thus comprises the expansion of a conventional tVNS stimulation device by various sensors that serve the control or variation of the stimulation parameters.

(11) The response to an event is named as a first embodiment.

(12) It is thus known that the heart rate of the patient increases briefly before an epileptic fit. The stimulation unit in accordance with the invention is able to monitor the progression of the heart rate and to adapt its stimulation to the current heart rate via an ECG sensor.

(13) The synchronization of the delivered pulses with periodically occurring processes of the patient is named as a second embodiment.

(14) Certain neurological processes are subject to a certain periodicity. The tVNS device in accordance with the invention can thus, for example, be synchronized to the physiological rhythm by means of an EEG sensor and can thus dramatically improve the therapeutic effect because it always treats in the sensitive phase of the patient.

(15) In a further example, the detection means is a breathing sensor that is configured to measure the periodic state of the sympathovagal system. The breathing sensor communicates the periodic state of the sympathovagal system and the tVNS device in accordance with the invention triggers in response to this breathing signal.

(16) In a further example, a closes loop embodiment is conceivable, i.e. a regulation of a parameter to a desired value or in a desired value range.

(17) By way of example, it can be named as an example for this that the tVNS influences the autonomous tone, more exactly the sympathovagal balance. If this tone is detected, for example, via pupillometry or skin conductivity sensors, the stimulation can be specifically influenced and can thus be adapted to the current need of the patient. The tone can be maintained in a specific desired value range individual to the patient in this manner, with the stimulation pulse or pulses serving as an actuator.

(18) It is pointed out that the aforesaid embodiments do not restrict the invention. A plurality of sensors is generally conceivable. All the vital parameters are generally suitable, but also external physical variables such as movement, temperature, or pressure.