DE102011119111A1 - Stimulation device for application of transmucosal electrical stimulation impulses to surface of mucous membrane portion of human, has holding element arranged at electrode carrier for fixing electrode carrier in mouth area or in nose - Google Patents

Abstract

The device (1) has a controller for generating electrical voltage between stimulation and reference electrodes. The electrodes are arranged on or in an electrode carrier (5). The electrode carrier is placed on a mucous membrane portion or in nose of human such that the electrodes have contact to the mucous membrane portion or nose. A holding element (6) comprising a rod-shaped part is arranged at the electrode carrier for fixing the electrode carrier in mouth area or in the nose in an inserted position. The electrode carrier is made from plastically deformable material.

Description

The invention relates to a stimulation device for applying a transmucosal (transcutaneous) electrical stimulation stimulus to the surface of a mucosal section of a person, the stimulation device having at least one stimulation electrode and at least one reference electrode and a control with which an electrical voltage can be generated between the electrodes.

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 is based on the method of transmucosal (transcutaneous) electrical nerve stimulation. In this method, pulse currents of different current forms, amplitudes, pulse durations and frequencies are applied through the (mucous) skin to different nerves and change their status parameters in an advantageous manner.

A stimulation device of the type mentioned is from the EP 2 026 872 B1 known. Here, a stimulation device with an electrode assembly is described, which comprises a completely housable in the pinna (auricle) housing. From this extend two curved, wire-shaped sections, which are designed as resilient mounts. Thus, the electrode assembly can be brought by gentle clamping in the pinna in the required position, so that the auditory canal can be acted upon with a transcutaneous stimulation stimulus. It has been proven that the vagus nerve is subjected to electrical stimulation in the region of the ear.

Although the prior art electrode assembly already leads to good treatment results, certain disadvantages of the arrangement have been found in practice.

The attachment of the stimulation device has, depending on the degree of miniaturization of the device more or less, the result that a third person can relatively easily recognize that a patient is using the stimulation device. This can have a certain stigmatizing effect, because of which the use of the device on the patient side is rejected.

Furthermore, when attaching the stimulation device on or in the ear, the hearing can be adversely affected. Furthermore, by the known generic devices certain cranial nerves such. As the Nervus glossopharyngeus and the trigeminal nerve, can not be achieved.

The invention is therefore based on the object to further develop a stimulation device of the generic type so that an efficient electrical nerve stimulation even the neurostimulation inaccessible cranial nerve branches is possible, yet it is achieved that the stimulation device is practically imperceptible to third parties.

The solution to this problem by the invention is characterized in that the at least one stimulation electrode and the at least one reference electrode are arranged on or in an electrode carrier, wherein the electrode carrier is designed to be placed in particular on a mucous membrane portion in the mouth or in the nose of the human to be that the at least one stimulation electrode and the at least one reference electrode contact the mucosal surface in the mouth or in the nose, wherein at least one holding element is arranged on the electrode carrier, with which the electrode carrier in the position inserted into the mouth or in the nose in the oral cavity or can be fixed in the nose.

The electrode carrier is preferably designed as a surface lying on the mucous membrane element, wherein it may in particular have a crescent-shaped or crescent-shaped shape. The holding element may comprise a first, web-shaped part which is attached to the electrode carrier and adapted for passage between two teeth of man, and a second contact part, which is attached to the first web-shaped part and for engaging behind the two teeth one in relation to the first, web-shaped part has greater width.

The holding element may also be formed as a hook-shaped part, which - is designed for hooking behind a tooth of man - in the manner of a brace.

According to another embodiment of the invention, and in particular for intranasal transmucosal electrostimulation, the electrode carrier may at least in sections have the shape of a cylinder or ellipsoid extending in a longitudinal direction. The holding element may in this case be designed as insertion restriction, which is arranged at an axial end of the electrode carrier and extends laterally to the longitudinal direction. Thus, the electrode carrier can not be inserted through a maximum insertion path in the nose. The retaining element formed as insertion restriction can, according to a preferred embodiment of the invention, connect two electrode carriers to one another, the two electrode carriers being designed in particular for insertion into both nostrils. The electrode carrier can have at least one air channel which passes through it along its entire longitudinal extent. This can be breathed easily even when inserted into the nose electrode carrier.

The electrode carrier preferably consists at least partially, preferably completely, of a plastically deformable material.

Particularly preferably, it is provided that the control is arranged on the electrode carrier or integrated in the electrode carrier. Thus, an integral, self-contained unit is created that can be placed in the mouth or nose and is invisible to third parties when using the stimulation device.

Furthermore, the invention relates to a method for transmucosal stimulation of the mucosa of the mouth or nose, wherein a stimulation device of the type described is inserted into the mouth or into the nose so that the electrodes of the stimulation device have contact with the mucosal surface.

In intraoral nerve stimulation, d. H. During electrical transmucosal nerve stimulation in the oral cavity, the trigeminal nerve can be reached via the nasopalatine nerve (scarpae) on the anterior third of the palate, the nasal posterior and the maxillary nerves.

Furthermore, the trigeminal nerve on the gum line of the upper dental arch can be reached via the superior alveolar nerves and, in turn, the maxillary nerve.

There is also good accessibility to the trigeminal nerve via the mucous membrane of the cheek, vestibulum oris, buccal buccal from the 2nd molar to the 2nd premolar to the buccal nerve, masticator nerve and the mandibular nerve.

Furthermore, the trigeminal nerve can be stimulated via the gums of the lower jaw, the inferior alveolar nerve and again the mandibular nerve.

Finally, there is good accessibility of the trigeminal nerve via the lingual mucosa of the lower jaw and the posterior area of the oral cavity, the lingual nerve and again the mandibular nerve.

The electrode carrier is adapted to the anatomical structure of the mouth or (by plastic deformation of the electrode carrier) customizable. The retaining element ensures a good fixation at the selected stimulation site.

The electrode carrier may be in the form of a brace which, as is known per se with such clips, is provided with a holding element in the form of a toothed armature.

The electrodes can be arranged on the electrode carrier so that both the gum and the inside of the lower or upper lip is given.

The electrode carrier may be nestled on the outside of the lower rack, wherein it is then arranged between the lower lip and the rack and has at least one holding element in the form of a toothed armature.

The electrode carrier can also be nestled on the outside of the upper rack, wherein it is then arranged between the upper lip and the rack and has at least one holding element in the form of a toothed armature.

The electrode carrier can be equipped with electrodes so that they have both the gum and the inside of the lower and upper lip.

The electrode carrier may have the shape of a three-dimensionally shaped bottom of the mouth and be provided with at least one holding element in the form of a toothed anchor.

It is also possible that the electrode carrier has two mirror-image three-dimensional molded plates or parts for the left and right side of the floor of the mouth.

The electrodes can be placed so that they both have contact with the floor of the mouth and the underside of the tongue.

The electrode carrier can be designed such that it has plaque electrodes held by plastically deformable connecting elements, which make contact both with the floor of the mouth and with the underside of the tongue.

Another possibility is to use as an electrode carrier a tampon, the is impregnated with an electrically conductive solution which is physiologically harmless.

Similarly, a sponge impregnated with an electrically conductive solution which is physiologically harmless may be used as the electrode carrier.

It is preferred that the electrodes are supplied with a stimulation current by a self-sufficient stimulation device (control), which is mounted or arranged within the oral cavity. The stimulation device, d. H. the controller can be connected to the electrode carrier to form a unit. In particular, the controller may be integrated in the electrode carrier.

As an alternative, however, is also possible to make the supply of the electrodes with a stimulation current through a control that is located outside the oral cavity; For example, the controller may be attached to the body or configured as a stationary stimulation device. Then, an electrical connection z. B. be made by a cable that is passed through the mouth opening.

In intranasal nerve stimulation, d. H. In electrical transmucosal nerve stimulation in the nose, there is good accessibility of the trigeminal nerve via the ethmoid anterior nerve to the nasal mucosa in front of the shells and on the lateral nasal wall, to the nasociliary nerve and the ophthalmic nerve.

Furthermore, the nervus trigeminus can be reached via the nasal mucosa of the upper and middle nasal passage and the septum to the nasal posterior lateral and septi innervating there and the maxillary nerve.

Finally, the trigeminal nerve can be stimulated via the inferior nasal passage and the antrum through the inferior rami nasales, the nervi palatini and the maxillary nerve.

The electrode carrier is in turn adapted to the anatomical structure of the nose height. The holding elements serve to fix the electrode carrier at the selected stimulation site and also to extract the electrode carrier from the nostril.

The electrode carrier is preferably made of a soft plastic, such as silicone, and has a fit in the nasal vestibule in front of the nasal turbinates and an anchor element protruding from the nostril, which bends outwardly in front of the nasal opening and the electrode carrier so in terms of maximum insertion depth into the nose in holding the correct position.

The electrode carrier preferably has a longitudinally extending air channel which has respective outside and inside breathing openings.

A preferred embodiment has two approximately mirror-inverted shaped electrode carrier, which are permanently connected to one another with a holding element arranged between the two nose openings in the form of a connecting web; this connecting web takes over the task of an anchor element at the same time.

The electrode carrier can also be designed as a tampon, which is impregnated with an electrically conductive and physiologically harmless solution. Furthermore, a drawstring can be fastened to the tampon in order to be able to pull it out of the nose in a simple manner.

Furthermore, the electrode carrier can also be designed as a sponge, which is impregnated with an electrically conductive and physiologically harmless solution. In turn, a drawstring can be attached to the sponge so that it can easily be pulled out of the nose again.

The supply of the electrodes with a stimulation current can in turn be carried out with a control, which is also housed in the nose height, for which purpose it is preferably arranged on the electrode carrier or integrated into it. Thus, there may be a fixed unit in which the controller is part of the electrode carrier.

Alternatively, it can also be provided that the supply of the electrodes with a stimulation current through an outside of the nasal cavity, for example on the body, arranged or stationary stimulation device (control) takes place, in which case a connection can be made to the electrode carrier via a guided through the nostril cable.

The proposed embodiment of a stimulation device provides the advantageous possibility of offering a hidden, non-stigmatizing neurostimulation to a patient who attaches importance to it, which is completely inconspicuous in everyday life because it is invisible. In this case, especially the self-sufficient embodiment of the device is interesting, in which the controller is integrated into the electrode carrier.

Advantageously, it is also possible-in comparison with the stimulation of the vagus nerve in the ear-to work with lower stimulation currents, because intraorally or intranasally on account of the present mucosa a lower contact resistance and a higher sensitivity exist.

Advantageously, in particular the trigeminal nerve is better achieved than in other stimulation approaches.

During intraoral stimulation, a nerve trunk of the glossopharyngeal nerve is detected particularly well, while in the intranasal stimulation primarily receptive fields can be applied.

The intraoral stimulator can be worn completely invisible for third parties under the tongue, where there is enough space for him to receive. The same is true for intranasal stimulation.

Due to the sufficient receiving space under the tongue an excellent wearing comfort can be realized and thus a good acceptance in the patient can be expected.

The stimulation device, and especially the electrode carrier, may or may not be adapted to the individual anatomical conditions of the floor or nasal cavity. The anatomical variability of the floor under the tongue is low in adults. Therefore, in any case over certain areas a single geometric configuration of the electrode carrier can be used.

The stimulator or the electrode carrier can be fixed well and securely by the mentioned toothed anchor, for which purpose the interdental spaces are used, through which a part of the holding element engages. This is very comfortable for the user. Hereby, the electrode carrier can be easily removed after use. One embodiment is based on bracket of thin wire, each loop around a molar of the left and right teeth. This type of fixation is a proven and accepted by the patient principle corrective braces. Slipping or even swallowing the electrode carrier is just as unlikely as with a prosthesis.

If the glossopharyngeal nerve is the target of stimulation, this nerve can be easily reached, as it runs as a palpable strand to the left and right of the tongue ligament at a depth of a few millimeters along the floor of the mouth. It is structurally not a problem, both nerves, d. H. the left and right, simultaneously with a stimulation device or with an electrode carrier to stimulate.

With regard to the materials that can be used for the parts of the stimulation device, dentistry has proven and succeeds ISO 10993 Approved materials available.

Due to the constantly moist environment (especially in the intraoral stimulation, given by the excretory ducts of the sublingual glands, which are in the immediate vicinity of the nerve cord), a good contact quality of the electrodes is achieved.

• – Neuralgien des Nervus glossopharyngeus;
• – Schluckstörungen bzw. Schlucklähmungen, vor allem nach Schlaganfall;
• – Schlundkrämpfe;
• – Stimulation des Speichelflusses bei Xerostomie, z. B. durch M. Sjögren;
• – Unterstützung logopädischer Maßnahmen;
• – Bruxismus.

Particular preferred applications of the proposed stimulation device are the following diseases and conditions:

• - Neuralgia of the glossopharyngeal nerve;
• - dysphagia or paralysis, especially after stroke;
• - pharyngeal spasms;
• - Stimulation of salivary flow in xerostomia, z. By M. Sjögren;
• - support of speech therapy measures;
• - bruxism.

The stimulation device is preferably completely self-contained and preferably hermetically welded. The charging of the required battery can be done inductively (as known from electric toothbrushes).

The available stimulation device receiving space does not require excessive miniaturization of the device.

In the drawings, embodiments of the invention are shown. Show it:

1 the view of an open mouth, in which a stimulation device is inserted in both the upper and the lower row of teeth,

2 one too 1 similar solution, wherein in addition a further stimulation device was inserted into the mouth,

3 the view of an open mouth with raised tongue, under which a stimulation device was inserted,

4 one too 3 alternative solution,

5 an electrode carrier according to a first embodiment of the invention,

6 an electrode carrier according to a second embodiment of the invention,

7 an electrode carrier according to a third embodiment of the invention,

8th an electrode carrier according to a fourth embodiment of the invention,

9 an electrode carrier according to a fifth embodiment of the invention,

10 a tampon-trained electrode carrier,

11 the section through a head, wherein an inserted into the nose electrode carrier is shown,

12 according to the electrode carrier 11 in front view,

13 the front view of a head, wherein in the nose of the electrode carrier according to 11 respectively. 12 is inserted, and

14 the section through a head, in the nose of an electrode carrier is inserted in the form of a tampon.

In the 1 to 10 is an intraoral stimulation by means of a stimulation device 1 shown.

In 1 An open mouth of a human being is shown, with the upper lip 14 and the (outgrown) lower lip 15 you can see. The tongue is still recognizable 16 and the suppository 17 ,

In the area between upper lip 14 and upper row of teeth is an electrode carrier 5 used, which is part of a stimulation device 1 is. The electrode carrier 5 has a shape adapted to the shape of said area and is provided with - not shown in this figure - stimulation and reference electrodes, with which a transmucosal electrostimulation can be made. The electrode carrier is thus on the gingiva (gingival) in the upper jaw (maxillary) and also contacts the labial mucosa (inner surfaces of the lips).

So that the electrode carrier 5 remains in the intended position during use, is a holding element 6 intended. This has a web-shaped part 7 (S. 7 ) on the electrode carrier 5 is formed; at his from the electrode carrier 5 the far end is at the web-shaped part 7 a widened part of the system 10 formed. The bar-shaped part 7 penetrates the tooth gap between two teeth 8th and 9 ; the widened part of the plant 10 engages behind these teeth and thus fixes the electrode carrier 5 ,

Analog is in the lower mouth between the lower lip 15 and the bottom row of teeth an electrode carrier 5 placed. This has in the present case two holding elements 6 on, the described embodiment with web-shaped part 7 and part of the system 10 have and in the manner described the electrode carrier 5 fix. The electrode carrier is thus again on the gingiva (gingival) and now in the lower jaw (mandibular) on.

Another additive or alternative electrode carrier 5 can - as in 2 to see - also in the palate area, so palatal, be arranged. For the embodiment and the holding element or the holding elements the same applies as stated above.

Another additive or alternative electrode carrier 5 can - as in 3 to see - also be arranged in the area under the tongue (sublingual). Again, the same applies to the embodiment and the holding element or the holding elements as stated above. The tongue 16 is shown raised here and the tongue ribbon 18 to recognize.

In 4 It can be seen that - for example for the sublingual area - the electrode carrier 5 shortened to stimulate only one half of the relevant range. Here is further illustrated that as an electrode carrier and such in the form of a tampon 19 can be used.

In the 5 to 10 are different embodiments of electrode carriers 5 respectively. 19 to see, in particular, the execution of the holding elements 6 is apparent.

The electrode carrier 5 are with stimulation electrodes 2 or reference electrodes 3 provided, between which an electrical potential can be established. This is done in the present case via a controller 4 placed in the electrode carrier 5 is integrated, as it is in the 5 and 8th is indicated.

At the electrode carriers 5 is usually the retaining element 6 as a web-shaped part 7 with terminally arranged and widened system part 10 formed, preferably from the material of the electrode carrier 5 , The web-shaped parts are inserted between a tooth gap and fixed the electrode carrier so in the mouth.

An adaptation to the anatomical conditions can be done by, for example, a notch 20 is provided.

The labial electrodes and the gingival electrodes are on different sides of the electrode carrier 5 arranged, at least for the maxillary and mandibular use (according to 5 : mandibular; according to 7 : maxillary). For the palatal application (s. 6 ), the arrangement of the electrodes on one side is sufficient.

8th shows the electrode holder for the double sublingual use, 9 show him for a simple sublingual use. In both cases, the electrodes are 2 . 3 again on both sides on the electrode holder 5 placed.

The tampon electrode 19 is in 10 to see.

In the 11 to 14 is an intranasal stimulation by means of a stimulation device 1 shown.

In 11 a head is shown in section, with the nasal cavity 21 can be seen. In the 12 illustrated stimulation device 1 here has two electrode carriers 5 in each case for insertion into a nostril, ie in the nostril 22 (S. 13 ) are formed. The electrode carrier 5 here have a (slightly curved) ellipsoidal shape and extend in a longitudinal direction L. As in 11 can be seen, both have electrode carriers 5 an air duct 11 with an outer opening 12 and an inner opening 13 , The air channels 11 make sure that even when used in the nose electrode carriers 5 breathing through the nose remains possible.

Both electrode carriers 5 are about a holding element 6 connected as best of all 12 and 13 is apparent.

Out 12 also shows that here again the controller 4 into one of the electrode carriers 5 is integrated, so that a compact and self-sufficient stimulation device is given.

In 14 an alternative solution is shown, according to the again an electrode carrier 19 used in tampon form. The electrode carrier 19 is here with a drawstring 23 provided in order to easily pull it out of the nose again.

LIST OF REFERENCE NUMBERS

1

stimulation device

2

stimulation electrode

3

reference electrode

4

control

5

electrode support

6

retaining element

7

web-shaped part

8th

tooth

9

tooth

10

plant part

11

air duct

12

outer opening

13

inner opening

14

upper lip

15

bottom lip

16

tongue

17

suppository

18

frenulum

19

Electrode carrier in tampon form

20

notch

21

nasal cavity

22

nostril

23

drawstring

L

longitudinal direction

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• EP 2026872 B1 [0004]

Cited non-patent literature

• ISO 10993 [0055]

Claims (10)

Stimulation device ( 1 ) for applying a transmucosal electrical stimulation stimulus to the surface of a mucous membrane portion of a human, the stimulation device ( 1 ) at least one stimulation electrode ( 2 ) and at least one reference electrode ( 3 ) and a controller ( 4 ), with which between the electrodes ( 2 . 3 ) an electrical voltage can be generated, characterized in that the at least one stimulation electrode ( 2 ) and the at least one reference electrode ( 3 ) on or in an electrode carrier ( 5 ) are arranged, wherein the electrode carrier ( 5 ) is adapted to be placed on a section of mucous membrane in the mouth or in the nose of the human being in such a way that the at least one stimulation electrode ( 2 ) and the at least one reference electrode ( 3 ) Have contact with the surface of the mucous membrane in the mouth or in the nose, 5 ) at least one retaining element ( 6 ) is arranged, with which the electrode carrier ( 5 ) in the mouth or nose position in the mouth or nose. Stimulation device according to claim 1, characterized in that the electrode carrier ( 5 ) is formed as a surface lying on the mucous membrane element, wherein the electrode carrier ( 5 ) in particular has a crescent-shaped or crescent shape. Stimulation device according to claim 2, characterized in that the holding element ( 6 ) a first, web-shaped part ( 7 ) located on the electrode carrier ( 5 ) and for passage between two teeth ( 8th . 9 ) of the human being, as well as a second part of the plant ( 10 ) at the first, ridge-shaped part ( 7 ) is attached and behind the two teeth ( 8th . 9 ) one in relation to the first, web-shaped part ( 7 ) has greater width. Stimulation device according to claim 2, characterized in that the holding element ( 6 ) is formed as a hook-shaped part, which is designed to hook behind a tooth of man. Stimulation device according to claim 1, characterized in that the electrode carrier ( 5 ) has, at least in sections, the shape of a cylinder or ellipsoid extending in a longitudinal direction (L). Stimulation device according to claim 5, characterized in that the retaining element ( 6 ) is designed as insertion restriction, which at one axial end of the electrode carrier ( 5 ) is arranged and extends laterally to the longitudinal direction (L). Stimulation device according to Claim 6, characterized in that the holding element ( 6 ) two electrode carriers ( 5 ), wherein the two electrode carriers are designed in particular for insertion into both nostrils. Stimulation device according to one of claims 5 to 7, characterized in that the electrode carrier ( 5 ) at least one air duct ( 11 ), which passes through it along its entire longitudinal extent. Stimulation device according to one of claims 1 to 8, characterized in that the electrode carrier ( 5 ) at least partially, preferably completely, consists of a plastically deformable material. Stimulation device according to one of claims 1 to 9, characterized in that the controller ( 4 ) on the electrode carrier ( 5 ) or in the electrode carrier ( 5 ) is integrated.

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