WO2012100913A1

WO2012100913A1 - Device for arranging on or in an ear for transcutaneous stimulation of a nerve

Info

Publication number: WO2012100913A1
Application number: PCT/EP2012/000136
Authority: WO
Inventors: Wolf Gerhard Frenkel; Andreas Hartlep; Christoph Beck
Original assignee: Cerbomed Gmbh
Priority date: 2011-01-26
Filing date: 2012-01-13
Publication date: 2012-08-02
Also published as: DE102011009528A1; DE102011009528B4

Abstract

The application relates to a device (1) for transcutaneous stimulation of a nerve of the human body, which device has at least one stimulation electrode (2) and at least one reference electrode (3) for transcutaneous nerve stimulation, wherein the at least one stimulation electrode (2) and the at least one reference electrode (3) communicate with a control unit (4) and can be subjected to an electrical current by the latter, wherein the at least one stimulation electrode (2) and the at least one reference electrode (3) are arranged in or on a housing (5) which is designed to be placed on or in the human ear, wherein the housing (5) has a bow-shaped continuation (6) designed to be introduced into the auditory canal, wherein the bow-shaped continuation (6) simulates the shape of the external acoustic meatus or the external auditory canal, and wherein the end of the bow-shaped continuation (6) is provided with an electrode head (7), which has at least two contacts (8, 9) for the at least two electrodes (2, 3). To achieve a reliable mode of operation with a high level of comfort, the application proposes that the bow-shaped continuation (6) is designed as an inherently stiff element and is or comprises a spring element (20) which is designed to generate an elastic contact force for placing the electrode head (7) on a section of the auditory canal.

Description

APPARATUS FOR MOUNTING ON OR IN AN EYE

TRANSCUTANEOUS STIMULATION OF A NERVO

The invention relates to a device for transcutaneous stimulation of a nerve of the human body, which has 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 connected to a control unit and from this with 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 or in the human ear, wherein the housing has a bow-shaped extension which is designed for insertion into the auditory canal, wherein the bow-shaped extension of the shape of the auditory canal entrance and the external auditory canal is modeled and wherein at the end of the bow-shaped extension an electrode head is arranged, the at least two contact points for the mind at least two electrodes.

Devices of the generic type are known in many ways. A transcutaneous nerve and muscle stimulation is used, for example, in sports medicine for stimulating a muscle, for this purpose Electrodes are placed on the skin or glued on. The advantage is that there is no trauma to the skin surface when the electrode is placed in position (non-invasive application of the electrode). This is also faced with previously known possibilities in which electrodes are implanted in or under the skin.

In devices for transcutaneous nerve stimulation, it is known to influence the neuroelectric quality and thus the function of the nerves to be stimulated by invasive or noninvasive electrical stimulation of the nerves. The aim of this approach is to induce psycho-vegetative changes such as stress reduction or to treat neuropsychiatric disorders.

Special significance has long been the stimulation of the vagus nerve. He is the tenth cranial nerve of the main nerve of the parasympathetic system. In addition, he is involved in the motor control of the larynx and throat and transmits taste sensations from the tongue base and touch sensations from the pharynx, the larynx and a part of the external auditory canal (Ramus auricularis).

In particular, invasive vagus nerve stimulation is now regarded as an established therapy method in neurology for the treatment of epilepsy, for example on Penry JK, Dean JC: Prevention of intractable partial seizures by intermittent vagal stimulation in humans: preliminary results. Epilepsy 1990; 31 Suppl 2: 40-43, and Uthman BM, Wilder BJ, Hammond EJ, Reid SA: Efficacy and safety of vagus nerve Stimulation in patients with complex partial seizures. Epilepsy 1990; 31 Suppl 2: 44-50. In this case, the patient is surgically exposed to the neurosurgical in the left neck area of the vagus nerve and wrapped with a current conductor as an electrode. The device for current pulse generation is implanted under the skin in the left shoulder area. The vagus nerve stimulator can later be programmed externally by means of an electromagnetic field. The electrical vagus nerve stimulation stimulates the brain in different areas, which can be demonstrated in imaging procedures. In addition to the effectiveness in epilepsy, the stimulation treatment also leads to mental effects, eg. B. to antidepressant effects, s. Elger G, Hoppe C, Falkai P, Rush AJ, Elger CE: Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res 2000; 42: 203-210.

Therefore, the method has recently been applied in psychiatry and has already proven itself in the treatment of otherwise refractory severe depression (see Carpenter LL, Friehs GM, Price LH: Cervical vagus nerve stimulation for treatment-resistant depression., Neurosurg Clin N 2003, 14: 275-282, Goodnick PJ, Rush AJ, George MS, Marangell LB, Sackeim HA: Vagus nerve stimulation in depression, Expert Opin Pharmacother 2001; 2: 1061-1063, and Rush AJ, George MS, Sackeim HA , Marangell LB, Husain MM, Giller C, Nahas Z, Haines S, Simpson RK, Jr., Goodman R: Vagus nerve stimulation (VNS) for treatment-resistant depressions: a multicenter study, Biol Psychiatry 2000; 47: 276-286 ).

For the stimulation of nerves in general, various solutions have already been proposed. The US 5,458,625 shows a device of the type mentioned for nerve stimulation by means of electrical impulses. The current pulses are introduced by means of electrodes which are attached to the earlobe of the patient.

Other solutions for introducing electrical impulses into the human body are known from JP 101 08 913 A, from DE 39 18 329 A1 and from FR 2 717 699 A1.

EP 0 645 162 B l describes a stimulation device for the stimulation of muscles and nerves, which comprises a function generator for generating a waveform with a sequence of pulses. It is especially intended for pain therapy. EP 0 757 573 A1 and EP 1 064 047 A I describe systems and methods for electrical nerve stimulation in general.

EP 1 145 736 A2 proposes an implantable, multimodal neurostimulator. EP 0972 538 A2 describes a system for delivering electrical stimulation to a part of the nervous system by means of a needle electrode. EP 1 048 319 A2 discloses a system for the selective activation of brain neurons, spinal parenchyma or peripheral nerves operating with an introducer cannula.

EP 1 022 034 A1 describes a method and a device for stimulating muscles or nerve tissue by generating pulse signals. EP 1 393 773 A1 describes an external nerve stimulator of the phrenic nerve by means of an oesophageal electrode. EP 0 962 234 A1 describes a device for electrical nerve stimulation, wherein a placement of the electrodes is not disclosed. WO 97/45160 describes a device for the modulation of neural brain plasticity. In WO 01/00273 a non-invasive method and apparatus for heart rate stabilization by means of skin electrodes is described. EP 1 420 854 A2 uses a diaphragmatic electrode for the treatment of neuropsychiatric disorders. Finally, EP 1 418 981 A1 stimulates nerves in the vicinity of the diaphragm to treat movement disorders. In the previously known solutions, the following circumstances have proven disadvantageous:

Numerous procedures require the invasive introduction of the stimulation electrode and in addition to the usual risks of anesthesia and surgery are particularly associated with the risk of nerve injury and infection risk.

If the therapy is unsuccessful, the stimulation device must be removed with the same risks as described above.

There is therefore an inhibition on the part of the patient to undergo such an operation.

In addition, under certain circumstances, the feeling of being delivered to a machine implanted in the body and not be able to easily get rid of this when needed. In addition, the devices described often have a large, unwieldy construction and are therefore suitable only for clinical use but not for domestic long-term stimulation. The stimulation device and electrodes are often connected by longer cables, which has a detrimental effect on handling.

Because of the handling (eg large adhesive electrodes), stimulation can only take place at a fixed berth, but not inconspicuously and not disturbing when performing daily work.

For a large-scale therapeutic use of the method of transcutaneous vagal stimulation, it is desirable to integrate the technique in a small handy, wireless as possible device that can be worn at any time, uncomplicated and unobtrusive.

The invention is therefore based on the object, a device of the type mentioned in such a way that this desire is satisfied. Ie. A device for nerve stimulation is to be created which enables a particularly efficient and simple stimulation of the vagus nerve in everyday life and in a simple and virtually invisible manner. The device should be applicable to the patient in a particularly simple manner and in particular make it possible, if necessary, to be able to be removed quickly from the body. An efficient external, non-invasive device for the stimulation of the vagus parts should be proposed, which is characterized by a high wearing comfort, whereby the stimulation should be possible at any time and uncomplicated. In addition, the patient is given the opportunity to control the therapy become. Furthermore, the device should turn off a simple, stable and safe stimulation method.

The solution to this problem by the invention is characterized in that, for optimal positioning of the electrodes, the bow-shaped extension is formed as an intrinsically stiff element, wherein it is a spring element or comprises a spring element for generating an elastic contact force for contacting the electrode head to a Section is formed, in particular on a surface region of the ear canal.

The spring element preferably extends along at least part of the extension of the bow-shaped extension.

The spring element according to a preferred embodiment of the invention consists of a shape memory material which assumes a predetermined shape when a predetermined temperature is reached. The spring element consists preferably of metallic alloys of nickel-titanium (NiTi), copper-zinc (CuZn), copper-zinc-aluminum (CoZnAl), copper-zinc-nickel (CuZnNi), iron-nickel-aluminum (FeNiAl) or from a shape memory polymer.

The use of said shape-memory material affords the advantage that a fit-fitting insertion of an otoplastic into the ear is thereby considerably simplified. First, namely, the bow-shaped extension can be bent into a position in which a problem-free insertion of the stimulation device in the ear is possible. Only then, when the spring element placed in the ear warms up by the body heat, it takes the original form and thus creates optimal investment conditions in the ear. The insertion of the ear into the ear is so essential especially if the user does not have sufficient fine motor skills (eg old people); the optimal fit of the earmold in the ear is ensured in each case. Alternatively, it is also possible that the spring element is a spring wire.

In this case, the spring element can run concentrically in the bow-shaped extension. The spring element is encased by the material of the bow-shaped extension. But it is also possible that the spring element is attached to one side of the bow-shaped extension.

If a spring element made of spring steel is used, it can be provided that the pretensioning force of the spring element is kept adjustable. This adjustment can be created for example by telescopically telescoping parts of the spring element. It is also possible to connect two spring elements by two sliding sleeves together so that the extension over which the two spring elements extend parallel to each other, is adjustable (like a bed slatted frame). About the setting of the parallel effective length of the two spring elements, the stiffness can then be adjusted by appropriate positioning of the sliding sleeves.

In this case, the device for stimulating the vagus nerve in the region of the external auditory canal and / or the auricle is designed and suitable.

Preferably, the control unit is arranged in the housing. But it can also be provided that the control unit is removable from the housing and is in communication with the electrodes. The connection can be a Be wire connection; but it is also possible a wireless connection, such as a wireless connection.

The electrode head is advantageously made of a soft material, in particular soft silicone. The contact points can be formed by metal balls. They can also be formed by flat surface electrodes. Furthermore, it is possible that the contact points are formed by an element made of a material with electrical surface conductivity, in particular a sponge with graphite inclusions.

The control unit may be suitable for influencing the frequency of an alternating current flowing through the electrodes. The same applies to the influence of the height of the current flowing through the electrodes, for influencing the length of pulses of the current flowing through the electrodes, for influencing temporal stimulation intervals of the current flowing through the electrodes and / or for influencing the time course of the through the electrodes flowing current.

Preferably, a rechargeable battery is arranged in the device, which supplies power to the control unit.

Furthermore, it can be provided that the device has a sensor for measuring a physiological parameter of the patient. This may be, for example, the pulse of the patient or the oxygen saturation of the blood of the patient. Furthermore, a memory chip for storing the data measured by means of the sensor can be provided. The electrodes can be integrated in the earpiece or in the headphones of a mobile phone handsfree device and the control unit can be integrated into a mobile phone. It can be provided that the connection between the electrodes and the control unit via a radio link, in particular via a blue-tooth connection or a WLAN connection takes place.

It is also possible that the electrodes are integrated in the headphones of a music playback device and that the control unit is integrated in the music playback device.

Since the vagus nerve also has afferent pathways in the skin of the external auditory canal, electrical vagus nerve stimulation is also possible through the skin of the ear and thus non-invasively by means of a transcutaneous electrode. It has already been proven that an electrical stimulation of the vagus nerve via afferents in the external auditory canal leads to a derivable potential on the cranial surface (sensory evoked potential). The proposed concept thus stimulates the nerve branches (ramus auricular nerve) of the vagus nerve, which extend in the area of the external auditory canal, and thus influence their function. This is achieved by integrating the technique of transcutaneous vagus nerve stimulation into a stimulation device to be worn on or behind the ear, which is similar in appearance to a hearing aid.

External (non-invasive) stimulation units for the vagus nerve in the ear area did not exist so far. Here, the invention provides a remedy. The previously known non-invasive nerve stimulation method by means of Current applications are used for peripheral nerve and muscle stimulation for pain therapy (transcutaneous electrical nerve stimulation - TENS), for muscle training (electrical muscle stimulation - EMS) or for electroacupuncture of certain meridian points. None of these procedures are designed to stimulate the vagus nerve in the ear area to induce changes in the central nervous system.

In contrast, the invention relies on transcutaneous vagus nerve stimulation in the ear area and proposes a particularly simple device for this purpose.

With the proposed invention, therefore, a transcutaneous stimulation of the vagus nerve, in particular for the treatment of neuropsychiatric disorders possible, with a placed in or on the external auditory canal stimulation electrode for transcutaneous stimulation of the auricular branch of the vagus nerve and a placed in or on the external auditory canal reference electrode is provided preferably connected to a control unit which is worn on or behind the ear. When the earpiece is inserted, the electrodes touch the skin surface of the external ear canal and can thus stimulate the vagus nerve parts located there.

With the spring element, it is advantageously possible that a defined biasing force of the arcuate extension or of the electrode head located at its end is exerted on a part of the auditory canal. If according to the preferred embodiment of the invention, a shape memory alloy (metallic or polymer material) used for the spring element, it can be achieved, for example, that z. B. at 28 ° C, the deformation of the spring material in a predetermined shape which is impressed on the spring element, takes place, so that gradually forms the desired defined bias after insertion of the electrode head into the ear canal and so the electrode head is brought into safe working position.

In the drawing, an embodiment of the invention is shown. 1 shows schematically the circuit diagram of a device for transcutaneous

Stimulation of the auricular branch of the vagus nerve and

2 shows the stimulation device, designed as a BTE (behind-the-ear)

Device.

In Fig. 1 the circuit diagram of a device 1 for transcutaneous vagus nerve stimulation is sketched. In particular, the auricular branch is stimulated to influence psycho-vegetative parameters. As a result, for example, can reduce the stress or it can be positively influenced depression or other neuropsychiatric disorders.

The device 1 basically consists of the stimulation electrode unit 1 1 (shown dashed on the left in FIG. 1) and of the control unit 4 (shown dashed in the right in FIG. 1).

The nerve is stimulated via the stimulation electrode 2. The reference electrode 3 serves as the electrical reference point. Both electrodes 2, 3 form the stimulation electrode unit 1 1. Electrodes 2 and 3 Transcutaneous stimulation is known, commercially available or easy to manufacture.

The stimulation frequency and the stimulation intensity are predetermined and generated by the control unit 4. The settings of these parameters are made via various controls 12. For transcutaneous stimulation oscillating signals are needed. These are generated by an oscillator 13 located in the control unit 4. In a logic and control circuit 14, the processing of the input and output signals, which are supplied via an input or output circuit 15 of the stimulation electrode unit 1 1 takes place. The power supply is taken over by a battery 10.

As can be seen in FIG. 2, the device 1 is similar in construction to a hearing aid worn behind the ear and has a housing 5. The stimulation electrode unit in the form of an electrode head or an ear electrode 7 is introduced into the external auditory canal, so that the stimulation electrode 2 and the reference electrode 3 come to rest on the skin surface. The connection between the electrode head 7 and the portion of the housing 5 shown on the left in Fig. 2 is formed as a bow-shaped extension 6, which also leads the entire supply and discharge lines between stimulation electrode unit and control unit; the bow-shaped extension 6 is placed over the upper edge of the auricle. At the end of the connection or transfer, the control unit 4 is in the housing 5 with an approximate size of 5 cm x 2 cm x 1 cm.

The bow-shaped extension 6 in this case has a coaxially extending in it spring element 20. It consists of a shape memory alloy. If the bow-shaped extension 6 inserted into the ear canal, it heats up due the body temperature. The material of the spring element (eg of an alloy of nickel and titanium - "nitinol") is chosen so that at about 28 ° C, the spring element returns to its original shape, which is impressed him, so that on the Electrode head 7 is applied a gentle biasing force, which so gradually applied to the desired part of the ear canal and presses.

Built into the control unit 4 is first a stimulation intensity regulator 16 for controlling the amplitude (strength) of the stimulation signal. Large amplitudes stimulate the nerve more than low amplitudes. In addition, the required stimulation intensity varies between individuals.

Further, a pacing frequency regulator 17 is included for controlling the frequency pattern of the stimulation signal. Thus, signals following one another at a greater distance can be driven quickly as well as signals which follow one another.

There is also an on / off switch 18 for activating or deactivating the device 1. A battery compartment 19 serves to accommodate a small button cell battery, preferably of the size 13 to 675.

An example of an application of the proposed device to the vagus nerve is as follows: The applied current is between 0.25 and 1.5 mA. The frequency of the current is between 20 and 30 Hz. The pulse width is between 250 and 500 μ5. The current is given every 3 to 5 minutes for about 30 sec.

The proposed stimulation device 1 is very small and is therefore ideal for home use. It gives the wearer a big one Freedom, because placement behind the ear is very beneficial and not disturbing.

The stimulation and reference electrodes 2, 3 must be in electrical contact with the skin surface of the patient, using pads 8 and 9, respectively, which may be formed as metallic beads. Hereby the electrodes 2, 3 lie on the inside of the tragus, d. H. an anatomical part of the auricle. The distance between the contact points 8, 9 is preferably between 1 mm and 15 mm, more preferably between 2 mm and 6 mm.

Another variant of the solution provides to introduce the ear piece further into the ear canal and there also to perform a vagus nerve stimulation. For this purpose, the electrodes 2, 3 z. B. be formed as a flat surface electrodes. Deeper in the auditory canal, more nerve endings of the vagus nerve are stimulated.

The electrodes 2, 3 are connected to cables (not shown), which are guided invisibly in the ear piece. The cable connections in turn are connected to the preferably located behind the ear control unit 4. The connection is made, as explained, via the bow-shaped extension 6. The setting of the stimulation frequency, the stimulation intensity, the pulse duration and the stimulation intervals and the current form takes place via the pacing frequency regulator 17.

Similar to an in-the-ear hearing aid, the entire technique can also be integrated in a device which lies in the concha of the ear and fills it. The device is powered by the battery 10 and is thus independent of an external power source. It can be provided that the power is supplied via a rechargeable battery 10, which is integrated in the housing 5. For the charging process, the device 1 is placed in a special box, which is connected to an external power source and, for example, via induction charges the battery 10 overnight.

The ear piece may additionally be provided with a sensor for measuring the pulse and the oxygen saturation, whereby such sensors for the measurement of the respiratory function and the pulse are known and commercially available. The measured values can be recorded on a memory chip, which is located in the housing 5 behind or in the ear, for later reading out by a physician via a wireless interface and to be able to evaluate by software. By changing the pulse rate variability calculated by the software, the physician can obtain important information about the psychovegetative modulation effect of the stimulation device and thus also receives control data on the course of the therapy. The described device can be made in its design according to standard values, or the ear piece and other parts can be made individually.

An alternative embodiment provides that the electrode head 7 and the control unit 4 are kept separate and connected via a cable.

As a further alternative, it may be provided to integrate the stimulation technique in a mobile telephone and its hands-free device. The control unit 4 and its electronics can in this case in the circuits be integrated in the mobile phone. The stimulation unit 7 with stimulation and reference electrode 2, 3 can be installed in the ear piece of the hands-free device. The communication between earpiece and mobile phone can be done both wirelessly, for example by means of Bluetooth technology, or via a connecting cable.

Furthermore, it is possible to integrate the technology in headphones and devices, for example, for digital media playback. This can be in addition to MP3 players in particular MD player or Discmans.

LIST OF REFERENCE NUMBERS

1 Device for transcutaneous stimulation of a nerve

2 stimulation electrode

3 reference electrode

4 control unit

5 housing

6 bow-shaped extension

7 electrode head

8 contact point

9 contact point

10 battery

1 1 stimulation electrode unit

12 controls

13 oscillator

14 logic and control circuit

15 input or output circuit

16 stimulation strength controls

17 pacing rate controls

18 on / off switch

19 battery compartment

20 spring element

Claims

claims:

1. Device (1) for transcutaneous stimulation of a nerve of the human body, comprising at least one stimulation electrode (2) and at least one reference electrode (3) for transcutaneous nerve stimulation, wherein the at least one stimulation electrode (2) and the at least one reference electrode (3) with a control unit (4) are connected and can be acted upon by this with an electric current, wherein the at least one stimulation electrode (2) and the at least one reference electrode (3) in or on a housing (5) are arranged, for attachment is formed on or in the human ear, wherein the housing (5) has a bow-shaped extension (6), which is designed for insertion into the ear canal, wherein the bow-shaped extension (6) of the shape of the auditory canal entrance or of the external auditory canal is modeled and wherein at the end of the bow-shaped extension (6) an electrode head (7) is arranged, the at least zw ei contact points (8, 9) for the at least two electrodes (2, 3), characterized in that the bow-shaped extension (6) is designed as an inherently rigid element, wherein it is a spring element (20) or includes such, the Generation of an elastic contact force for conditioning the electrode head (7) is formed on a portion of the ear canal.

Apparatus according to claim 1, characterized in that the spring element (20) extends along at least part of the extension of the bow-shaped extension (6).

Apparatus according to claim 1 or 2, characterized in that the spring element (20) consists of a shape memory material which assumes a predetermined shape upon reaching a predetermined temperature.

Device according to claim 3, characterized in that the spring element (20) consists of metallic alloys of nickel-titanium (NiTi), copper-zinc (CuZn), copper-zinc-aluminum (CuZnAl), copper-zinc-nickel (CuZnNi), Iron-nickel-aluminum (FeNiAl) or consists of a shape memory polymer.

5. Apparatus according to claim 1 or 2, characterized in that the spring element (20) is a spring wire.

6. Device according to one of claims 1 to 5, characterized in that the spring element (20) concentrically in the bow-shaped extension (6).

7. Device according to one of claims 1 to 6, characterized in that it is designed and suitable for stimulation of the vagus nerve in the region of the external auditory canal and / or the pinna.

8. Device according to one of claims 1 to 7, characterized in that the electrode head consists of a soft material, in particular made of soft silicone.

9. Device according to one of claims 1 to 8, characterized in that it comprises a sensor for measuring a physiological parameter of the patient.

10. Apparatus according to claim 9, characterized by a memory chip for storing the data measured by means of the sensor.