WO2011141103A1

WO2011141103A1 - Electrode arrangement for at least partially inserting into a ear canal of a person

Info

Publication number: WO2011141103A1
Application number: PCT/EP2011/001697
Authority: WO
Inventors: Christoph Beck; Stefan Bär
Original assignee: Cerbomed Gmbh
Priority date: 2010-04-15
Filing date: 2011-04-06
Publication date: 2011-11-17
Also published as: DE102010015277B4; DE102010015277A1

Abstract

The invention relates to an electrode arrangement (1) for at least partially inserting into an ear canal of a person in order to provide a transcutaneous electrical stimulation to the surface of the ear canal, wherein the electrode arrangement (1) has an elastic retaining element (2), which is designed for retention in the pinna (3), and wherein the electrode arrangement (1) has an electrode head (4), which bears at least one stimulation electrode (5) and at least one reference electrode (6). In order to achieve high durability of the arrangement together with good adaptability to the auditory canal, the retaining element (2) and the electrode head (4) are designed as separate components, which are connected to each other by means of a form-closed and/or force-closed connection element (7, 8; 7', 8').

Description

Electrode arrangement for at least partial introduction into a human ear canal

The invention relates to an electrode assembly for at least partial introduction into a human ear canal to exert on the surface of the ear canal a transcutaneous electrical stimulation stimulus, wherein the electrode assembly comprises an elastic holding element, which is designed for mounting in the pinna, and wherein the electrode assembly comprises an electrode head comprising at least one stimulation electrode and at least one reference electrode.

It is generally known to influence the neurophysiological and neuroelectric quality and thus the function of the stimulated nerves by invasive and non-invasive stimulation of the nerves. As a result, various disease states can be treated. There are numerous devices for both invasive and non-invasive stimulation.

The present invention focuses on the method of transcutaneous electrical nerve stimulation. In this method, pulse currents of different current forms, amplitudes, pulse durations and frequencies are applied through the skin to different nerves and change their status parameters in an advantageous manner. An electrode arrangement of the aforementioned type is known from EP 2 026 872 Bl. Here, an electrode assembly is described which comprises a completely housable in the pinna (auricle) housing. From this extend two curved, wire-shaped sections, wherein these 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.

Another stimulation device is known from US 5 514 175.

Although the previously known electrode arrangement already leads to good treatment results, certain disadvantages of the arrangement have been found in practice. Since, of course, the electrode arrangements have to build very small with their electrodes, the mechanical stability of the required connections, in particular the electrodes with their connecting cables, so far not optimally solved. Therefore, it may lead to insufficient support of the electrodes, which is facilitated by the fact that a very soft conformable material (in particular silicone) must be used for the holder in order to achieve sufficient comfort. Occasionally, with appropriate mechanical loading of the electrode assembly as it is inserted into the ear canal irreparable damage to the contacts of the electrodes.

Furthermore, it has been recognized as disadvantageous that it is difficult to adapt an existing electrode arrangement, if necessary, to the individual size of the pinna or the auditory canal. Another negative aspect is that it is currently very difficult to repair a damaged electrode assembly. This is usually uneconomical, so that currently in case of damage, the entire arrangement must be replaced.

The invention is therefore based on the invention to develop an electrode arrangement of the generic type so that the disadvantages mentioned are overcome. Thus, an electrode arrangement is to be proposed with which even larger mechanical loads can be reliably transmitted, wherein the electrodes can be securely held in position and there is no danger that their electrical contacts will be damaged. Furthermore, a simple possibility is to be created to be able to adapt the electrode arrangement to different sizes if required. Finally, a possibility should be created to be able to carry out an economic repair in the event of damage to the electrode assembly.

The solution to this problem by the invention is characterized in that the holding element and the electrode head are formed as separate components, which are connected to one another via at least one positive and / or non-positive connection means.

The retaining element is preferably made of a softer material than the electrode head. It preferably consists of an elastomeric material, in particular of silicone or of a material which comprises silicone. However, the electrode head preferably consists of a thermoplastic or duroplastic plastic material, in particular of polyurethane. The at least one stimulation electrode and the at least one reference electrode may be at least partially embedded in the material of the electrode head. They can be inserted during injection molding of the electrode head with in the injection mold and then encapsulated by the material of the electrode head.

Furthermore, electrical connection cables between the electrodes and a connecting cable can be embedded in the electrode head. For this purpose too, it can be provided that the injection-molding technique known per se is used.

The positive and / or non-positive connection means may have a projection arranged on the holding element or on the electrode head, which engages in a congruently shaped recess in the electrode head or in the holding element. The projection and the recess are tolerated to each other to produce a frictionally firm connection with each other so advantageous that the projection sits in the folded state of the holding element and the electrode head with a press fit in the recess. The projection may have a non-circular shape in a section perpendicular to its longitudinal axis, which produces or supports the positive engagement. The projection is designed conically in the direction of its longitudinal axis according to a preferred embodiment of the invention. In this case, the diameter can increase at a distance from the holding element, so that after assembly, a particularly strong frictional bond between the holding element and the electrode head is formed.

The holding element can furthermore have a preferably cylindrical connecting section extending in the direction of a longitudinal axis, at its end remote from the electrode head a bow-shaped section is arranged. The latter serves to hold the electrode arrangement in the pinna. The longitudinal axis of the projection and the longitudinal axis of the connecting portion can be perpendicular to each other. The positive and / or non-positive connection means may also be alternatively or additionally formed as a snap connection, which are effective between the holding element and the electrode head and hold these parts together positively in the folded state. The snap connection may have at least one hook-shaped projection, which is preferably formed on the holding element; this can engage in at least one congruent recess, which is preferably formed on the electrode head.

On the holding element may finally be formed a stop which limits the insertion of the electrode head into the ear canal. Thus, the maximum insertion of the electrode assembly is limited in the ear canal and so injury can be avoided.

It is advantageous that a much more stable construction is achieved by the proposed embodiment of the electrode assembly, without negatively affecting the wearing comfort. The electrodes are held stable and reliable in the required position, since they are arranged on the relatively stable electrode head. The electrodes are therefore held securely in the longitudinal direction of the electrode arrangement, in particular if a hard polyurethane material is used for the electrode head. There is no risk of damage to the electrical connections between the electrodes and the connection cable. The electrode assembly is protected due to the proposed design against a break at a lateral pressure, which was previously a certain problem. Due to the two-part design, it is now also possible to replace the holding element (preferably made of silicone). This is interesting from the point of view that differently sized holding elements can be used in order to be able to adapt the electrode arrangement to ears of different sizes or different ear shapes. On the other hand, this opens up an economic possibility of repairing the electrode arrangement in the event of damage.

The proposed solution also has the advantage that the production of the components can be made simpler, so that a better dimensional stability of the components and thus of the entire electrode arrangement is made possible.

There is an easy way to produce the electrode assembly (earmold) in a mirror image manner (by mirroring the CAD data of the construction), so that mirror-image electrodes for both ears can be inexpensively manufactured in two mold cavities of the same injection mold.

In the drawing, an embodiment of the invention is shown. Show it:

Fig. 1 shows the view of a pinna (auricle), in which a

Electrode assembly is used for applying a transcutaneous stimulation stimulus, 2 is a perspective view of the electrode assembly consisting of a holding element and an electrode head in the fully assembled, not inserted into the ear canal (force-free) state,

Fig. 3 shows the electrode assembly of FIG. 2 in exploded view and

Fig. 4 is a plan view of the electrode head of the electrode assembly, wherein the holding element of the electrode assembly is indicated by dashed lines.

FIG. 1 shows the pinna 3 of a human being, into which an electrode arrangement 1 has been inserted, with which a transcutaneous electrical stimulation of the skin surface of the auditory canal or auditory canal is to take place. In any case, the electrode assembly 1 is partially inserted into the ear canal of a human ear, wherein after insertion the position shown in Fig. 1 is taken. With the electrode arrangement 1, a transcutaneous electrical nerve stimulation can be performed on the inner surface of the auditory canal - where the vagus nerve runs. For this purpose, the electrode arrangement has a stimulation electrode and a reference electrode (see below), between which an electrical potential is generated; the funds required for this purpose are well known in the art, so they need not be further described here. Reference is made by way of example to DE 10 2005 003 735 B4 of the Applicant and reference is hereby expressly made.

The electrode assembly 1 comprises a holding element 2 made of silicone, which consists of a connecting portion 14 and a bow-shaped portion 15th consists. The connecting section 14, at the end of which an electrode head, which can not be seen in FIG. 1, is arranged, as already mentioned partially extends into the auditory canal. The bow-shaped portion 15 is due to its elastic material property in a position to apply elastic to the inner contour of the pinna and thus to produce a holding function for the electrode assembly 1. In FIGS. 2 to 4, the electrode arrangement 1 can be seen in detail in different views. In Fig. 2, the arrangement is completely assembled to see, where it is not yet used in the Pinna. Accordingly, no forces act on the holding element 2 in this illustration. The same applies to the illustration according to FIG. 3, where an exploded view can be seen. In Fig. 4, only the electrode head of the arrangement is outlined.

The electrode assembly 1 consists essentially of two parts, namely the holding element 2 and the electrode head 4. The electrode head 4 carries in the exemplary embodiment, a stimulation electrode 5 and a reference electrode 6, between which an electrical potential can be established. For this purpose, two connection cables 9 and 10 are connected to a power source. The two connection cables 9, 10 are discharged via a connecting cable 1 1 from the electrode head 4. It should be noted at this point that any types are possible to build the electrical potential between the electrodes 5, 6, ie to put the two connecting cables 9, 10 under tension. One possibility is to discharge the connection cable 1 1 from the area of the pinna and to give up the voltage via an external device of the electrode arrangement 1. Alternatively, however, it is also possible to miniaturize the voltage-generating unit together with the controller into the electrode arrangement 1 or to arrange it so that the entire stimulation device can be accommodated in the pinna. It is essential that the holding element 2 and the electrode head 4 are formed as separate components. These are connected to one another via a positive and / or non-positive connection means 7, 7 ', 8, 8'.

As can be seen in particular in Fig. 3, said positive and non-positive connection means 7, 8 are formed in the embodiment, first of all by a projection 12 which is integrally formed on the support member 2 to this.

Assigning a longitudinal axis R to the connecting section 14, the longitudinal axis L of the prismatic projection 12 in the exemplary embodiment is substantially perpendicular to this. In the electrode head 4, a recess 13 is provided, which corresponds to the shape of the projection 12, but is formed slightly smaller in size. If only the projection 12 is inserted into the recess 13 (pressed in), both a positive and a frictional connection between the holding element 2 and the electrode head 4 is produced. The positive connection can thereby be produced particularly well if a non-circular cross-section of the projection 12 and thus of the recess 13 is provided, as can be clearly seen in FIG. 4 in plan view. The adhesion is, however, generated by the interference fit, which is present between the projection 12 and the recess 13 in the mounted state of the electrode assembly 1.

In the exemplary embodiment, it is additionally provided that a further form-locking connection in the form of the connecting means 7 ', 8' holds the two parts holding element 2 and electrode head 4 together.

In Fig. 3 it can be clearly seen that a hook-shaped projection 7 'is integrally formed on the holding element 2, which can engage in a corresponding recess 8' in the electrode head 4. Accordingly, here is a connection made in the manner of a snap connection.

The maximum insertability of the electrode head 4 in the ear canal is limited by a stop 16 which is molded onto the holding element 2.

For the retaining element 2 is preferably used as the material biocompatible silicone, which is soft and gently rests against the inner contour of the Pinna 3. The electrode head 4 with the overmolded electrodes 5, 6, however, preferably consists of a thermosetting material, in particular hard polyurethane. Since both the electrodes 5, 6 and the connection cables 9, 10 are encapsulated by the material of the electrode head 4, a stable hold for these relatively sensitive parts is ensured, which provides a sufficient mechanical strength. Damage to these components is excluded in this respect. A particularly secure hold of the electrodes 5, 6 in the material of the electrode head results from, for example, formed as recesses undercuts 5 ', 6', which - as can be seen in Fig. 2 - an axial tearing of the electrodes 5, 6 difficult or prevent. The use of the positive or non-positive connection means 7, 7 ', 8, 8' is basically arbitrary. Combinations of these agents or exclusively positive or non-positive means can be used.

LIST OF REFERENCE NUMBERS

1 electrode arrangement

2 retaining element

3 Pinna

4 electrode head

5 stimulation electrode

5 'undercut (puncture)

6 reference electrode

6 'undercut (puncture)

7, 7 'connecting means

8, 8 'connecting means

9 connection cable

10 connection cable

1 1 connection cable

12 lead

13 recess

14 connecting section

15 bow-shaped section

16 stop

L longitudinal axis

R longitudinal axis

Claims

claims:

1. Electrode arrangement (1) for at least partial introduction into a human auditory canal in order to exert on the surface of the auditory canal a transcutaneous electrical stimulation stimulus, wherein the electrode arrangement (1) comprises an elastic retaining element (2) which is designed for mounting in the pinna (3 is formed, and wherein the electrode assembly (1) comprises an electrode head (4) carrying at least one stimulation electrode (5), characterized in that the holding element (2) and the electrode head (4) are formed as separate components, via at least one positive and / or non-positive connection means (7, 8, 7 ', 8') are interconnected.

2. An electrode assembly according to claim 1, characterized in that the electrode head (4) further carries at least one reference electrode (6).

3. An electrode assembly according to claim 1 or 2, characterized in that the holding element (2) consists of a softer material than the electrode head (4).

4. Electrode arrangement according to one of claims 1 to 3, characterized in that the holding element (2) consists of a biocompatible elastomeric material, in particular made of silicone or of a material having silicone.

5. electrode assembly according to one of claims 1 to 4, characterized in that the electrode head (4) consists of a thermoplastic or thermosetting plastic material, in particular of polyurethane.

6. An electrode arrangement according to one of claims 1 to 5, characterized in that the at least one stimulation electrode (5) and optionally present at least one reference electrode (6) in the material of the electrode head (4) are at least partially embedded, in particular by an injection molding encapsulated are.

7. An electrode assembly according to claim 6, characterized in that electrical connection cable (9, 10) between the electrodes (5, 6) and a connecting cable (1 1) are embedded in the electrode head (4).

8. Electrode arrangement according to one of claims 1 to 7, characterized in that the positive and / or non-positive connection means (7, 8) on the holding element (2) or on the electrode head (4) arranged projection (12) which in a congruent shaped recess (13) in the electrode head (4) or in the holding element (2) engages.

9. electrode assembly according to claim 8, characterized in that the projection (12) and the recess (13) are tolerated to each other so that the projection (12) in the assembled state of the holding element (2) and electrode head (4) with a press fit in the Recess (13) sits.

10. An electrode assembly according to claim 8 or 9, characterized in that the projection (12) in a section perpendicular to its longitudinal axis (L) has a non-circular shape.

1 1. An electrode assembly according to one of claims 8 to 10, characterized in that the projection (12) in the direction of its longitudinal axis (L) is conical, wherein the diameter increases with increasing distance from the holding element (2).

12. Electrode arrangement according to one of claims 1 to 11, characterized in that the holding element (2) extending in the direction of a longitudinal axis (R) extending, preferably cylindrical connection section (14), at its end remote from the electrode head (4) a bow-shaped portion (15) is arranged.

Electrode arrangement according to one of claims 8 to 11 and 12, characterized in that the longitudinal axis (L) of the projection (12) and the longitudinal axis (R) of the connecting portion (14) are perpendicular to each other.

Electrode arrangement according to one of claims 1 to 13, characterized in that the positive and / or non-positive connection means (7 ', 8') are designed as a snap connection, between the holding element (2) and the electrode head (4) are effective and these parts hold together positively in the assembled state.

Electrode arrangement according to claim 14, characterized in that the snap connection has at least one hook-shaped projection (7 '), which is preferably formed on the holding element (2), which can engage in at least one congruent recess (8'), which preferably at the electrode head (4 ) is formed.

16. Electrode arrangement according to one of claims 1 to 15, characterized in that on the holding element (2) has a stop (16) is formed, which limits the insertability of the electrode head (4) in the ear canal.