Electrode device for electrical stimulation, electrode body thereof and method for manufacturing the electrode device

Abstract

An electrode body (20) of an electrode device for electrically stimulating tissue of a living being is described, the electrode device being particularly used for nerve stimulation. The electrode body (20) is designed to be arranged at a location between the skull and the scalp of the living being. The electrode body (20) has a stimulation surface, which is designed to contact the tissue of the living being so as to generate electrical stimulation to the tissue by means of alternating current pulses and / or direct current pulses. The electrode body (20) comprises: a portion having at least 50 mm 2 The stimulation surface has an area of ​​at least 20 mm 2 The invention relates to a stimulation surface of an area of ​​1000 mm / s; and an additional surface treatment that can increase the effective stimulation surface; a fixing structure for fixing the electrode body (20) to the tissue of a living being; a conductor connection part, via which the electrode body (20) can be connected to an electrical conductor (4) by soldering, bonding, welding or other connection technology, for electrically connecting the electrode body (20) to an electrical device or another electrode body (20); the electrode body (20) can be completely surrounded by an electrically insulating carrier material (6) except for the stimulation surface; and / or the electrode body (20) has grooves (16) arranged in a circumferentially distributed manner for fixing the electrode body (20) in the carrier material (6). In addition, an electrode device and a method for producing the electrode device are provided.

Description

Technical Field

[0001] The present invention relates to an electrode body of an electrode device, the electrode device is used for electrically stimulating biological tissue, especially for nerve stimulation. The present invention also relates to an electrode device for electrically stimulating biological tissue, especially for nerve stimulation. In addition, the present invention also relates to a method for manufacturing an electrode device for electrically stimulating biological tissue. Background Art

[0002] Such electrode bodies and electrode arrangements generate an electric field in the region of biological tissue to electrically stimulate the tissue, wherein the electrodes are fed by an energy source. The terms electrode and electrode body are essentially equivalent, wherein the term electrode body is used hereinafter in particular to describe the construction and structure of such electrodes of an electrode arrangement.

[0003] EP 2 709 716 A1 shows a device for implantation in or on the head, wherein the device has a housing in which a plurality of electrodes are arranged, wherein the electrodes generate an electric field in a specific area of ​​the head. The device is designed to receive and send data via a W-LAN.

[0004] WO 2005 / 002665 A2 discloses an electrode system for implantation in the human body, which has two electrode rows, wherein a plurality of electrodes arranged side by side in a line are arranged in one electrode row. The electrode rows can be controlled with different voltages, wherein an electric field is generated.

[0005] EP 2 038 004 B1 shows an electrode system for implantation outside the skull at the head, which electrode system has a plurality of disk electrodes, wherein the disk electrodes are arranged in a matrix. Here, depending on the application, the selected disk electrodes can be controlled by a switching subsystem in order to generate the desired electric field without having to change the position of the disk electrodes. Summary of the invention

[0006] Based on this, the object of the present invention is to provide an improved electrode body of an electrode arrangement and an improved electrode arrangement. In addition, the object of the present invention is to provide an improved method for producing an electrode arrangement.

[0007] This object is achieved by an electrode body having the features of the invention. Advantageous embodiments are described herein.

[0008] Accordingly, an electrode body of an electrode device is proposed, which is used for electrically stimulating the tissue of a living being, in particular for nerve stimulation. In this case, the electrode body is configured to be arranged at a position between the skull and the scalp of the living being. The electrode body has a stimulation surface, which is configured to contact the tissue of the living being so as to generate electrical stimulation to the tissue by means of alternating current pulses and / or direct current pulses. This also includes combined or superimposed alternating current pulses and direct current pulses, for example also asymmetric pulses, which do not have the same instantaneous current flow or integrated current flow in the positive and negative directions.

[0009] The electrode body can have a stimulation surface having a surface area of ​​at least 50 mm 2 The electric field generated by the electrode body of the electrode device is weakened by the skull of the creature. At least 50mm through the electrode body 2 The stimulation surface of the present invention generates a sufficiently strong electric field without damaging the stimulation surface due to the electrochemical process, which can better compensate for this weakening caused by the skull. In addition, if electric pulses with long pulse durations are applied, at least 50 mm 2 A large stimulation surface has been shown to be advantageous because the electrical pulses at a constant current intensity result in a lower current density on the stimulation surface, thereby reducing irreversible electrochemical processes. In addition, the potentially stimulable brain area is increased. A relatively large stimulation surface also has a positive effect on the signal-to-noise ratio.

[0010] Alternatively or additionally, the electrode body can have an area of ​​at least 20 mm 2 The present invention also provides a surface treatment which can increase the effective stimulation surface. For example, in such a surface treatment, a rougher or uneven surface or even a fractal surface can be produced, which results in an increase in the surface area and a reduction in the transition impedance between the electrode body and the tissue, so that the signal-to-noise ratio is improved.

[0011] Alternatively or additionally, the electrode body can have a fastening structure for fastening the electrode body to biological tissue.

[0012] Alternatively or additionally, the electrode body can have a conductor connection, via which the electrode body can be connected to an electrical conductor by soldering, adhesive bonding, welding or another connecting technique in order to be able to electrically connect the electrode body to an electrical device or to a further electrode body.

[0013] Alternatively or additionally, the electrode body can be completely surrounded by an electrically insulating carrier material, except for the stimulation surface. This enables a simple arrangement and fixing of the electrode body in a superordinate structure, in particular in an electrode device. In addition, leakage currents and short-circuit currents are prevented or at least reduced by the electrically insulating carrier material. In this case, the electrode body can also be surrounded by a variety of electrically insulating carrier materials. For example, a polyimide substrate can be applied to the electrode body, the polyimide substrate being additionally embedded in silicone.

[0014] Alternatively or additionally, the electrode body can have grooves which are arranged in a circumferentially distributed manner for fixing the electrode body in a carrier material. Such grooves have the advantage that the electrode body can be better fixed in the carrier material, in that an improved form-fitting connection can be achieved. During production, an initially liquid carrier material, such as silicone, enters into the grooves of the electrode body, wherein after the carrier material has hardened, the electrode body is firmly connected to the carrier material. The grooves can be arranged, for example, annularly around the fastening opening of the electrode body and / or along the electrode edge.

[0015] In a particularly advantageous embodiment, the carrier material has an at least partially surrounding first sealing lip on the exposed contact side of the electrode body. The surrounding sealing lip has the following advantages: the electrode body is protected from undesired interactions with the surrounding environment at the implantation site, wherein the surrounding sealing lip provides an insulation portion, which remains intact even when the electrode body or the electrode device that accommodates the electrode body is deformed. In this way, the durability can be improved compared to the electrode bodies and electrode devices known from the prior art, and short circuits caused by electrolytes or tissues located between the electrode and the skull can be prevented or at least significantly reduced. In addition, the signal-to-noise ratio is also improved. It is conceivable that the surrounding first sealing lip can be formed in one piece from the carrier material.

[0016] Advantageously, the at least partially surrounding first sealing lip protrudes from the electrode body by 0.05 mm to 1 mm, in particular by 0.1 mm to 0.3 mm. It has been shown that these dimensions ensure the flexibility of the electrode body and of the electrode arrangement accommodating the electrode body and at the same time provide effective insulation of the electrode body from external influences. The sealing lip can extend from the electrode body in any spatial direction. For example, the sealing lip can extend from the electrode body in the direction normal to the stimulation surface and / or centripetally relative to the stimulation surface.

[0017] According to an advantageous embodiment, the electrode body is designed to be round, oval, ring-shaped or bean-shaped. Such a shape results in a good contact of the electrode body with the biological tissue.

[0018] Advantageously, the conductor connection of the electrode body is designed as a tangential conductor connection. The tangential conductor connection is perpendicular to the connecting line between the contact point and the center point of the electrode body. The conductor that can be connected to the electrode body via the conductor connection contacts the electrode body like a tangent. This has the following advantages: the connection point is relieved of load in the event of mechanical loading of the electrical conductor, for example by tension, so that the probability of damage to the connection point and thus failure of the electrode is reduced. The electrical conductor can be welded or soldered to the electrode body, for example.

[0019] However, it is also conceivable to configure the conductor connection part of the electrode body as a right-angle conductor connection. A right-angle conductor connection is understood to be a conductor connection that intersects the contour line or circumference line of the electrode body at right angles in the connection area, so that a right angle is formed between the conductor and the contour line or circumference line in the connection area. Compared with a tangential conductor connection, a right-angle conductor connection extends parallel to the connection line between the contact point and the center point of the electrode body, but not perpendicular to the connection line. This conductor connection shape is advantageous, for example, in the case of a polyimide substrate.

[0020] In an advantageous embodiment, an electrical conductor is connected to the conductor connection for electrically connecting the electrode body to an electrical device or to another electrode body.

[0021] Advantageously, the electrical conductor is extended in a corrugated manner. The corrugated arrangement reduces the loads on the electrical conductor, in particular in its connection region, which can be generated, for example, by bending and stretching of the electrode arrangement that accommodates the electrode body. The load reduction can be further improved by arranging the conductor on a curved track. Advantageously, the curved track extends around the primary electrode over an angle range of 40° to 100° based on a 360° system.

[0022] According to an advantageous embodiment, the connection between the electrical conductor and the electrode body is sealed, in particular with epoxy resin. This has the advantage that the sensitive connection is protected from external influences, such as liquids, which could cause failure of the electrode, for example due to corrosion.

[0023] In an advantageous embodiment, the conductor consists of a material or material combination which, in an ion-containing solution, does not form electrochemical local units with the material of the electrode body. This material selection reduces the probability of corrosion processes which could cause damage to the electrode or conductor.

[0024] Advantageously, the electrode body or at least the stimulation surface consists completely or partially of a biocompatible and inert material, for example platinum-iridium, which has a high charge injection capacity either by itself or by a special coating, for example with iridium oxide or graphene.

[0025] Advantageously, the fastening structure of the electrode body has an insulating sleeve which is designed to insulate the mechanical fastening element relative to the electrode body. The insulating sleeve thus provides electrical insulation of the mechanical fastening element, such as a screw, so that no undesired current flows from the electrode body to the fastening element.

[0026] The fastening structure of the electrode body can have fastening means embedded in the carrier material at the circumference or at one end of the electrode body, or also near or adjacent to the electrode body, in order to connect the electrode body to biological tissue.

[0027] In an advantageous embodiment, the fixing structure has at least one fastening opening in the electrode body, through which the electrode body can be fixed to the tissue of the organism by means of a mechanical fastening element, such as a screw, a nail, a clamp, a wire or a similar mechanical fastening element. It is also particularly advantageous if the above-mentioned insulating material sleeve is arranged in the fastening opening. The electrode body can then be fixed, for example, to the bone structure of the organism via the fastening opening in that the mechanical fastening element, such as a screw, is guided through the fastening opening, particularly advantageously through the insulating material sleeve arranged in the fastening opening and fixed to the bone structure. However, other fastening mechanisms, such as surgical wires for fixing the electrode body, are also conceivable. In this case, the fastening opening, and advantageously also the insulating material sleeve arranged in the fastening opening, is configured so that it is possible to fix an alternative fastening mechanism. For example, in the case of surgical wires, the insulating material sleeve has at least two openings.

[0028] According to an advantageous embodiment, the insulating sleeve has an at least partially circumferential second sealing lip. This has the advantage that the electrode body is protected from liquid, which can reach the electrode body through the gap between the electrode body or the electrode arrangement accommodating the electrode body and the insulating sleeve. It is conceivable that the insulating sleeve or the circumferential second sealing lip can be formed in one piece from the carrier material.

[0029] Advantageously, the insulating sleeve is at least partially made of polyetheretherketone (PEEK). PEEK is a high-temperature-resistant thermoplastic, which is also used in medical technology. PEEK has the advantage that it is biocompatible and transparent to X-rays. In addition, the material has a low coefficient of friction, which enables only a small amount of force to be transmitted from the fastening means, such as a screw, to the insulating sleeve and then to the electrode body, thereby protecting the electrode body from damage, such as in the form of deformation. PEEK also acts as an electrical insulator, so that no undesired current can flow between the electrode body and the mechanical fastening means.

[0030] According to an advantageous design of the present invention, the electrode body has a preformed concave stimulation surface. Such a stimulation surface can be optimally adapted to the outer shape of a large part of the skull region of a living being. Thus, the electrode body is better matched to the curvature of the bone structure.

[0031] Alternatively, the electrode body can have a preformed planar stimulation surface having at least one cutout and / or recess, by which a flexible adaptation of the electrode body to the outer contour of the skull of a living being is improved.

[0032] Advantageously, the electrode body is also suitable for detecting biological electrical signals of a living being. For example, an electroencephalogram (EEG) or an electrocardiogram (EKG) or an electromyogram (EMG) can be recorded with the aid of the electrode body. For this purpose, an amplifier with an analog and digital converter (ADC) and optionally an analog or digital signal filter can be connected to or integrated into the electrode body, which can be used for diagnostic purposes or for controlling stimulation immediately after the detection of the biological electrical signals of the living being. For this purpose, an evaluation and control unit can also be connected to the electrode body, or can be integrated into an energy source that can be connected to the electrode body.

[0033] In an advantageous embodiment, the area of ​​the electrode body is at most 7.1 cm 2 , especially the area of ​​​​maximum 4.6cm 2 This relatively small structure of the electrode body can achieve good integration and reduce the intervention of biological tissue, thereby reducing the risk of tissue damage.

[0034] According to an advantageous embodiment, the electrode body has a thickness of at most 2 mm, in particular a thickness of at most 1 mm. In this way, the device formed by means of one or more electrode bodies can also have a small thickness, for example a thickness of less than 3 mm, less than 2 mm or less than 1 mm. In this way, the implanted electrode device hardly protrudes under the scalp of the living being. This has the advantage of aesthetics, in that the implanted electrode device is not perceived by the surroundings. In addition, the probability of damage caused by external influences is reduced because the potential area for such damage is reduced. The wearing comfort of the living being is also improved by the smaller thickness.

[0035] The object is also achieved by an electrode arrangement having the features of the invention. Advantageous embodiments are described herein.

[0036] Therefore, an electrode device for electrically stimulating biological tissue, in particular an electrode device for nerve stimulation, has at least one primary electrode and at least one secondary electrode. In this case, one, more or all primary electrodes are respectively formed by an electrode body and / or one, more or all secondary electrodes are respectively formed by an electrode body.

[0037] At least one primary electrode and at least one secondary electrode are each connected to a connecting element by means of an electrical conductor, wherein the connecting element is designed for connection to a further electrode or an energy source. Alternatively or additionally, the primary electrode and the secondary electrode are arranged on a common carrier material.

[0038] The electrodes of the electrode device are connected to a connecting element, wherein the connecting element can be connected to an energy source and / or an electrical signal source to supply current to the electrodes. The electrical signal source can be set up to send electrical stimulation signals. The electrodes can be embedded in a carrier material. The connecting element can have a plug connector or be configured as a plug connector. However, it is also conceivable that the connecting element is configured as a polyetheretherketone adapter, which is a transition between the electrode device and the energy source or the electrical signal source. Here, the energy source and / or the signal source can be implanted in a biological body at a position different from the electrode device, wherein the energy source can be connected to the connecting element by means of an electrical conductor, and the electrical conductor can be welded or soldered to the connecting element.

[0039] The object is also achieved by an electrode arrangement having the features of the invention. Advantageous embodiments are described herein.

[0040] Therefore, an electrode device for electrically stimulating the tissue of a living being is proposed, which is particularly used for nerve stimulation, wherein the electrode device is configured to be arranged at a location between the skull and the scalp of the living being. The electrode device has at least one primary electrode and at least one secondary electrode. The electrode device also has a stimulation surface, which is configured to contact the tissue of the living being so as to generate electrical stimulation to the tissue by means of alternating current pulses and / or direct current pulses. This also includes combined or superimposed alternating current pulses and direct current pulses, for example also asymmetric pulses, which do not have the same instantaneous current flow or integrated current flow in the positive and negative directions.

[0041] The electrode device according to the invention can be designed for implantation between the scalp and the skull of a living being. In the field of neurostimulation for epileptic patients in particular, where drug treatment is ineffective, the most invasive method has been used so far, usually by implanting intracranial electrode systems, in order to provide relief for the respective patients. The electrode device according to the invention can be implanted on the skull of a living being in order to achieve the necessary stimulation of a specific brain region, which represents a significantly less invasive intervention for the patient and thus represents a lower burden on the patient.

[0042] The electrode arrangement can have an area of ​​at least 50 mm 2 The total size of the stimulation surface of the primary electrode and / or the total size of the stimulation surface of all secondary electrodes. The electric field generated by the electrode device is weakened by the skull of the living being. At least 50mm through the electrode device 2 This weakening caused by the skull can be better compensated for by a stimulation surface of at least 50 mm in size that generates a sufficiently strong electric field without damaging the stimulation surface by electrochemical processes. In addition, if electric pulses with long pulse durations are applied, then 2 The stimulation surface of a certain size has been shown to be advantageous, because the electric pulses cause a lower current density on the stimulation surface at a constant current intensity, thereby also reducing irreversible electrochemical processes. In addition, the potentially stimulable brain area is increased. A relatively large stimulation surface also has a favorable effect on the signal-to-noise ratio. The electrode surface is limited in this respect by the overall size of the electrode device so that the electrode device can still be implanted in the human body.

[0043] Alternatively or additionally, the electrode arrangement can have an area of ​​at least 20 mm 2The overall size of the stimulation surface of the primary electrode and / or the overall size of the stimulation surface of all secondary electrodes, and additional surface treatments that can increase the effective stimulation surface. For example, in such surface treatments, rougher or uneven surfaces or even fractal surfaces can be produced, resulting in an increase in the surface area and a reduction in the transition impedance between the electrode body and the tissue, so that the signal-to-noise ratio is improved.

[0044] Alternatively or additionally, the electrode arrangement has a fastening structure for fastening the electrode arrangement to biological tissue.

[0045] Alternatively or additionally, except the stimulation surface of the primary and secondary electrodes, the electrode arrangement can be completely surrounded by an electrically insulating carrier material. This can realize the simple arrangement and fixing of the electrode arrangement on the biological tissue. In addition, leakage current and short-circuit current are prevented or at least reduced on the electrode by the electrically insulating carrier material. In this case, the electrode arrangement can also be surrounded by a variety of electrically insulating carrier materials. For example, a polyimide substrate can be applied to the primary and / or secondary electrode, and the polyimide substrate is additionally embedded in the silicone.

[0046] In an advantageous embodiment of the electrode device, a reinforcing element, in particular a reinforcing mesh, is arranged on the carrier material. Such a reinforcing element can increase the tensile strength of the electrode device. This has the advantage that the geometrical accuracy of the electrode device, i.e. the orientation of the primary electrode and the secondary electrode with respect to each other, and thus the required electric field can be ensured, can be ensured. Advantageously, the reinforcing element is a reinforcing mesh, for example a surgical mesh, the strands of which extend between the primary electrode and the secondary electrode. It is possible here that specific parts of the electrode device do not have a reinforcing element. Thus, for example, it is conceivable that no such reinforcing element is arranged on the contact section of the electrode device in order not to reduce its flexibility.

[0047] According to an advantageous embodiment of the electrode arrangement, at least one electrical conductor is at least partially surrounded by a carrier material. This has the advantage that the electrical conductor is held in its position on the carrier material. This avoids undesired displacements of the electrical conductor. In addition, the electrical conductor is insulated from external influences, so that the electrical conductor is shielded, for example, from liquids, thereby preventing undesired reactions.

[0048] Advantageously, the thickness of the electrode device is less than 4 mm, in particular less than 2 mm. In this way, the implanted electrode device barely protrudes below the scalp of the living being. This has aesthetic advantages, wherein the implanted electrode device is not perceptible to the surroundings. In addition, the probability of damage by external influences is reduced, since the potential area for such damage is reduced. The smaller thickness also improves the wearing comfort of the living being.

[0049] According to an advantageous embodiment, the electrode arrangement has at least one primary electrode and at least two secondary electrodes. It is particularly advantageous if the electrode arrangement has at least four secondary electrodes. A larger number of electrodes allows a more precise control of the electric field configuration, which can be advantageous, for example, due to inhomogeneities in the electrical conductivity of the tissue or in order to focus the electric field more precisely on a tissue area. In addition, in the case of a plurality of electrodes, it is possible to choose between a plurality of channels for signal derivation, which increases the information content. It is advantageous if the electrode arrangement has between three and eight secondary electrodes, in particular just four secondary electrodes.

[0050] Advantageously, at least one electrical conductor of the secondary electrode is arranged in a corrugated manner around the primary electrode, wherein the corrugated arrangement of the electrical conductor extends along a curved track around the primary electrode. The corrugated arrangement reduces mechanical loads on the electrical conductor, in particular on its connection region, which can be generated, for example, by bending and pulling the electrode arrangement. The load reduction is further improved by the arrangement on a curved track. Advantageously, based on a 360° system, the curved track extends around the primary electrode over an angle range of 40° to 100°.

[0051] In principle, the carrier material of the electrode device can have fastening structures, by means of which the electrode device can be fixed to the bone structure of a living being. The fastening structures can be designed, for example, as screw holes or eyelets for producing a joint connection.

[0052] Alternatively or in combination, at least one of the primary electrode and / or the secondary electrode has at least one fastening opening, wherein an insulating material sleeve is provided in each fastening opening. Then, the electrode device can be fixed to the biological tissue structure via the fastening opening, in the manner of guiding a fastening mechanism such as a screw through the insulating material sleeve provided in the fastening opening and fixing it to the tissue structure. However, other fastening mechanisms, such as surgical wires for fastening electrodes, are also conceivable. In this case, the insulating material sleeve is configured so that the fixing of the alternative fastening mechanism is feasible, for example, in the case of surgical wires, fixing is performed by at least two openings in the insulating material sleeve. By fixing via the primary electrode and / or the secondary electrode, the remaining electrodes can be simultaneously kept in the desired position, and improved contact with the skull can be achieved, so that during the implantation time of the electrode device, a desired electric field can also be generated at the desired position. This fixation also reduces the undesirable tissue ingrowth between the electrode and the skull. Furthermore, the insulating material sleeve provides for electrical insulation of the fastening means, so that no undesired current flow from the primary electrode and / or the secondary electrode to the fastening means can occur.

[0053] The insulating sleeve can be made at least partially of polyetheretherketone (PEEK). PEEK is a high-temperature-resistant thermoplastic, which is also used in medical technology. PEEK has the advantage that it is biocompatible and transparent to X-rays. In addition, the material has a low coefficient of friction, which allows only a small amount of force to be transmitted from the screw to the insulating sleeve and then to the corresponding electrode, thus protecting the electrode from damage such as deformation. PEEK also acts as an electrical insulator, so that no undesired current can flow between the electrode and the screw.

[0054] The insulating sleeve of the electrode arrangement can have an at least partially circumferential second sealing lip. This has the advantage that the electrode is protected from liquids that can reach the electrode through the gap between the electrode arrangement and the insulating sleeve. It is conceivable that the insulating sleeve or the circumferential second sealing lip can be formed in one piece from the carrier material.

[0055] Alternatively or in combination, the primary electrode and / or at least one of the secondary electrodes have grooves arranged in a circumferentially distributed manner for fixing in a carrier material. Such grooves have the advantage that the primary electrode and the secondary electrode can be better held in a fixed manner in the carrier material, in that an improved form-fitting connection can be achieved. During production, an initially liquid carrier material, such as silicone, enters the grooves of the primary electrode and of the secondary electrode, wherein after the carrier material has hardened, the primary electrode and the secondary electrode are firmly connected to the carrier material. The grooves can be arranged, for example, in an annular manner around the fastening opening of the primary electrode and / or of at least one of the secondary electrodes and / or along the electrode edge of the primary electrode and / or of at least one of the secondary electrodes.

[0056] Alternatively or in combination, the connection point of the electrical conductor to the primary electrode and / or to at least one of the secondary electrodes is a tangential conductor connection. The tangential conductor connection is perpendicular to the connecting line between the contact point and the center point of the corresponding electrode. The conductor contacts the electrode like a tangent. This has the advantage that the connection point is relieved in the event of mechanical loading of the electrical conductor, for example by tension, so that the probability of damaging the connection point and thus causing failure of the corresponding electrode is reduced. The electrical conductor can be welded or soldered to the electrode, for example.

[0057] However, it is also conceivable that the connection point of the electrical conductor to the primary electrode and / or to at least one of the secondary electrodes is formed as a right-angled conductor connection. A right-angled conductor connection is understood to be a conductor connection that intersects the contour line or circumference line of the electrode in the connection area at right angles, so that a right angle is formed between the conductor and the contour line or circumference line in the connection area. In contrast to a tangential conductor connection, a right-angled conductor connection extends parallel to the connection line between the contact point and the center point of the electrode, and does not extend perpendicularly to the connection line. This form of conductor connection is advantageous, for example, in the case of polyimide substrates.

[0058] In an advantageous embodiment, the electrode arrangement has a contact section, wherein the connecting element is arranged on the contact section and wherein the contact section protrudes laterally from the electrode arrangement. The protruding contact section enables the connecting element to be mechanically isolated from the region of the primary electrode and the secondary electrode, so that undesired interactions are avoided.

[0059] It is also advantageous if the length of the contact segment is greater than its width. The length is the dimension in the direction of projection of the contact segment, wherein the width is the dimension transversely to the direction of projection of the contact segment. By means of a slim design, forces acting on the contact segment can be dissipated so that they do not enter the region of the electrode and possibly cause damage there.

[0060] It is also advantageous if a fastening element for screw fastening is provided on the contact section. The fastening element can be designed, for example, as an elongated hole, wherein the contact section can be fastened to the living being by means of a screw or other fastening means. In this way, the contact section can be securely fastened to the living being, wherein mechanical forces can be dissipated via the skull. The fastening element can be arranged such that it forms a hexagonal bearing, wherein the rotational and translational degrees of freedom are limited.

[0061] According to an advantageous embodiment, the total area of ​​the secondary electrode is greater than the area of ​​the primary electrode. This embodiment enables good current distribution on the biological tissue surface and reduced risk of tissue damage. It is also advantageous if the primary electrode and / or the secondary electrode each have a 50 mm 2 Up to 71mm 2 area, especially 20mm 2 Up to 46mm 2 With the aid of the electrode surface, a particularly good current distribution can be achieved with reduced risk of tissue damage.

[0062] Alternatively, in an advantageous design, the total area of ​​the secondary electrodes can also be smaller than the area of ​​the primary electrodes. This design allows a reversed stimulation current direction, like anodic stimulation, instead of cathodic stimulation, without causing electrode damage due to corrosion. Thus, different indications and clinical manifestations can be treated.

[0063] Advantageously, the secondary electrodes are arranged on at least one circular track around the primary electrode. In another advantageous embodiment, the secondary electrodes of the electrode arrangement can be arranged equidistantly on at least one circular track around the primary electrode. It is also advantageous that the secondary electrodes are distributed on concentric circular tracks around the primary electrode. This distribution of the secondary electrodes around the primary electrode additionally helps to generate an electric field through a shield, such as a skull cap.

[0064] According to an advantageous embodiment, the center point of at least one of the secondary electrodes is arranged at a distance of 5 mm to 55 mm, in particular 10 mm to 50 mm, from the center point of the primary electrode. It is also advantageous that the edge of at least one of the secondary electrodes is arranged at a distance of 1 mm to 8 mm, in particular 2 mm to 6 mm, from the edge of the primary electrode. It has been shown that a small distance between the secondary electrodes and the primary electrode enables optimal focusing of the electric field, wherein the probability of leakage currents and short-circuit currents is reduced or such leakage currents and short-circuit currents are prevented by a sufficient distance between the secondary electrodes and the primary electrode and the penetration depth of the electric field into the head can be increased. The distance thus forms an optimized intermediate path between the opposite focusing requirements and leakage currents or short-circuit currents. A larger distance between the electrodes results in a higher signal, but also a lower degree of focusing.

[0065] Advantageously, the carrier material has at least one recess, wherein the recesses are respectively arranged between adjacent secondary electrodes. It is also conceivable that the carrier material has a tapering in sections, i.e. a reduced or smaller material thickness. In this way, the electrode arrangement can be constructed to be flexible. The recesses or tapers increase the flexibility, in particular at the secondary electrodes, wherein a recess or taper is advantageously provided between every two adjacent secondary electrodes. Thus, by means of the increased flexibility, it is possible to react to irregular surfaces of the skull of a living being in such a way that the electrode arrangement has sufficient contact with the skull at any position.

[0066] It is proposed that the carrier material has an at least partially surrounding first sealing lip on the exposed contact side of the primary electrode and / or at least one of the secondary electrodes. The surrounding sealing lip has the following advantages: the electrode is protected from undesired interactions with the surrounding environment at the implantation site, wherein the surrounding sealing lip provides an insulation part, which remains intact even when the electrode device is deformed. In contrast to the electrode devices known in the prior art, the durability can be improved and short circuits caused by electrolytes or tissues located between the electrode and the skull can be prevented or at least significantly reduced. In addition, the signal-to-noise ratio is also improved. It is conceivable that the surrounding first sealing lip can be formed in one piece from the carrier material.

[0067] According to an advantageous embodiment, the at least partially surrounding first sealing lip at least partially extends beyond one, several or all primary electrodes and / or at least partially beyond one, several or all secondary electrodes by 0.05 mm to 1 mm, in particular by 0.1 mm to 0.3 mm. It has been shown that these dimensions ensure the flexibility of the electrode arrangement and at the same time provide effective insulation of the electrodes from external influences. The sealing lip can extend beyond the electrode body in any spatial direction. For example, the sealing lip can extend beyond the electrode body in the normal direction of the stimulation surface and / or centripetally relative to the stimulation surface.

[0068] Any insulation described in this application, for example an insulation formed by a carrier material or a sealing lip, also contributes to improving the signal quality of the electrode, so that the signal-to-noise ratio is improved.

[0069] The connection points of the electrical conductor to the primary electrode and / or at least one of the secondary electrodes can be sealed, in particular with epoxy resin or another sealant. This has the advantage that the sensitive connection points are protected from external influences, such as liquids, which could cause failure of the corresponding electrode, for example due to corrosion.

[0070] Advantageously, the conductor is made of a material which does not form electrochemical local units in an aqueous electrolyte solution as long as it is in electrical contact with the electrode material. This choice of material reduces the probability of corrosion processes which could cause damage to the electrode or conductor.

[0071] The object is also achieved by a method having the features of the invention. Advantageous embodiments are described herein.

[0072] Therefore, a method for producing an electrode device for electrical stimulation of biological tissue is provided, in particular a method for producing an electrode device according to the above features.

[0073] In method step a), the electrode body is made of a film of electrode material with a suitable thickness, for example by laser cutting or stamping. In method step b), a surface coating and / or a surface structured portion is optionally applied to at least a portion of the electrode surface. In method step c), an electrical conductor is applied to each electrode body, or the electrical conductor is made in one piece with the electrode. In method step d), epoxy resin or another electrical insulator is optionally applied to the connection point. In method step e), the shape of the electrode device is made of a carrier material. In method step f), the electrode body and any electrical conductors, as well as any reinforcing elements, are embedded. In method step g), the electrical conductor is connected to the contact section of the electrode device.

[0074] The object is also achieved by a method having the features of the invention. Advantageous embodiments are described herein.

[0075] Therefore, a method for producing an electrode arrangement for electrical stimulation of biological tissue is proposed, in particular a method for producing an electrode arrangement according to the above features.

[0076] In method step a), a carrier material is provided. In method step b), one or more electrode bodies are produced on the carrier material by a vapor deposition process and / or by electrodeposition. In method step c), a surface coating and / or a surface structuring is optionally applied to at least a portion of the electrode surface. In method step d), the carrier material is optionally embedded in a further insulating carrier material.

[0077] In an advantageous embodiment of the method, at least one electrical conductor for electrically connecting the electrode body to an electrical device or a further electrode body is produced by a vapor deposition process and / or by electrodeposition and connected to the electrode body. BRIEF DESCRIPTION OF THE DRAWINGS

[0078] The invention is explained in more detail below by way of example with reference to the accompanying drawings. The accompanying drawings show:

[0079] Figure 1 shows a schematic structure of an electrode body;

[0080] Figure 2 A schematic diagram of an electrode body is shown with a connected electrical conductor and an insulating material sleeve;

[0081] Figure 3 Show Figure 2 A schematic diagram of an electrode body in which the electrode body has a carrier material;

[0082] Figure 4 A schematic diagram showing a plurality of electrode bodies connected to an energy source via electrical conductors;

[0083] Figure 5 A schematic diagram showing an electrode body embedded in a carrier material in side view;

[0084] Figure 6 A schematic diagram showing an electrode device in top view;

[0085] Figure 7 A schematic diagram of an electrode arrangement is shown in a side view, the electrode arrangement having an electrode embedded in a carrier material;

[0086] Figure 8 A schematic diagram showing a method for manufacturing an electrode device;

[0087] Fig. 9 A schematic diagram shows a further method for producing an electrode arrangement. DETAILED DESCRIPTION

[0088] Figure 1 The schematic structure of the electrode body 20 is shown. The electrode body 20 shown here is designed as a round electrode. However, other electrode shapes are also conceivable. It is clear that the electrode body 20 has a fastening opening 10 for fastening to a living being. It is also clear that the electrode body 20 has grooves 16 arranged in a distributed manner over its circumference. The grooves 16 enable an improved fastening of the electrode body 20 to the living being. Figure 3 In the carrier material 6 shown in FIG. 2 , in the manufacturing of the electrode body 20 Figure 6 In the case of the electrode arrangement 1 shown in FIG. 1 , the carrier material 6 is distributed in the recesses 16 , so that the electrode body 20 can be fixedly held after the carrier material 6 has hardened.

[0089] Figure 2 The electrode body 20 which is also configured as a circular electrode is schematically shown, and the electrode body has a connected electrical conductor 4. In order to connect the electrical conductor 4, a conductor connection 7 is provided on the electrode body 20, and the conductor connection can be configured, for example, as a protrusion extending from the circular surface of the circular electrode, so as not to reduce the effective stimulation surface of the electrode body 20. At present, the conductor connection 7 is configured as a tangential conductor connection 7, so that the connected electrical conductor 4 contacts the electrode body 20 like a tangent. Therefore, when a tensile force occurs, the connection part is relieved, thereby preventing damage to the conductor connection part 7 and the resulting failure of the electrode. The electrical conductor 4 can be soldered or welded to the conductor connection part 7 of the electrode body 20, wherein it is advantageous that the connection part is sealed, for example, with epoxy resin, to protect it from external influences. It can be recognized that the electrical conductor 4 is stretched in a corrugated shape. This reduces the load on the electrical conductor 4, especially the load in its connection area on the conductor connection 7, which can be generated, for example, by bending and pulling the electrode device 1 that accommodates the electrode body.

[0090] It can also be seen that the electrode body 20 has a fastening opening 10, into which an insulating material sleeve 11 is inserted. Therefore, the electrode body 20 can be fixed to the skull of a living being via a fastening element, such as a screw, through the insulating material sleeve 11. The insulating material sleeve 11 prevents: excessive torque is transmitted to the electrode body 20 and thus damages the electrode body. In addition, an undesirable current flow between the electrode body 20 and the fastening element is avoided. The insulating material sleeve 11 can be composed of polyetheretherketone, for example. By fixing the electrode body 20 via the fastening opening 10, the precise orientation of the electrode body 20 can be ensured, which can generate the desired electric field in the target area.

[0091] exist Figure 3 Shown in Figure 2 . It can be seen in this view that the electrode body 20 is embedded in the carrier material 6 represented by the hatching. The carrier material 6 is electrically insulating and completely surrounds the electrode body 20 except for the stimulation surface. The carrier material 6 can be composed of silicone, for example. However, other materials that meet the application-related properties (biocompatibility, flexibility, electrical insulation, etc.) are also conceivable. The carrier material 6 enables the electrode body 20 to be simply arranged and fixed in the superstructure, in particular in the electrode device 1. In addition, the electrically insulating carrier material 6 prevents or at least reduces the occurrence of leakage currents and short-circuit currents.

[0092] Furthermore, electrode body 20 has recesses 16 . During the production process, initially liquid carrier material 6 enters into recesses 16 and thus assists in fixing electrode body 20 in carrier material 6 after curing.

[0093] Figure 4 Schematically, a plurality of electrode bodies 20, namely a total of four electrode bodies 20, are shown, which are connected to an energy source 21 via an electrical conductor 4. The energy source 21 can be designed as a supply source in order to supply the electrode body with current so that the electrode body can be operated. Alternatively or additionally, the energy source 21 can be designed as a signal source in order to generate electrical stimulation signals in a targeted manner on the electrode.

[0094] It can be seen that the electrode body 20 does not have to be directly connected to the energy source 21. An arrangement is also conceivable in which the electrode body 20 is connected to another electrode body 20, which in turn is connected to the energy source 21. For this purpose, the corresponding electrical conductor 4 extends between the electrode body 20 and the energy source 21 or between the two electrode bodies 20. By indirectly connecting the electrode body 20 to the energy source 21 via the other electrode body 20, it is also possible to reach tissue areas that are far away from the energy source 21 without having to maintain a longer electrical conductor 4 or to extend the electrical conductor and thus expose it to a higher risk of load. Obviously, multiple electrode bodies 20, that is, more than two electrode bodies, can also be connected to another electrode body 20. Multiple conductors 4 can be soldered, for example, side by side on the conductor connection 7 provided for connecting the electrical conductors 4. In principle, of course, it is also conceivable to use a longer conductor 4 for the electrode body 20 that is farther away in space and to connect the other electrode body 20 that is closer in space as a branch.

[0095] Figure 5 The electrode body 20 embedded in the carrier material 6 is shown in a side view. It can be seen that the electrode body 20 has a continuous fastening opening 10, wherein an insulating material sleeve 11 is arranged in the fastening opening 10, and wherein the electrode body 20 can be fixed to the bone or other tissue structure of a living being via the insulating material sleeve 11 by means of a fastening element (not shown). It is clear that the carrier material 6 has a first circumferential sealing lip 14 on the contact side 15 of the electrode body 20. The circumferential sealing lip 14 can be formed in one piece from the carrier material. In this way, although the electrode body 20 is not flat, it can still be fixed at the site to be implanted without deformation occurring on the electrode body 20. It is also conceivable that the circumferential sealing lip 14 partially protrudes from the electrode body 20, thereby enabling improved fixation of the electrode body 20 in the carrier material 6. It can also be seen that the electrode body 20 is exposed on the contact side 15 and is covered by the carrier material 6 in an insulating manner on the other side. The electrode body 20 is thus embedded in the carrier material 6. This allows effective insulation of electrode body 20 to the outside and at the same time ensures the generation of the desired electric field in the body region facing contact side 15. It is also conceivable for insulating sleeve 11 to have a circumferential second sealing lip (not shown) which additionally contributes to this effect.

[0096] Figure 6A schematic diagram of an electrode arrangement 1 is shown in a top view. For illustration purposes, the electrode arrangement 1 is partially cut away, wherein the different layers of the electrode arrangement 1 are recognizable. The electrode arrangement 1 has a primary electrode 2, wherein the primary electrode 2 is surrounded by four secondary electrodes 3. The secondary electrodes 3 are arranged on a common circular track surrounding the primary electrode 2. The primary electrode 2 and the secondary electrode 3 are connected to a connecting element 5 via an electrical conductor 4, wherein the connecting element 5 is designed for connection to an energy source 21. The primary and secondary electrodes 2, 3 can advantageously have the other features of the electrode body 20 described above.

[0097] It is clear that the components (primary electrode 2, secondary electrode 3, electrical conductor 4 and connecting element 5) are arranged on a carrier material 6. The carrier material 6 can be made of silicone, for example. However, other materials can also be considered, which meet the application-related properties (biocompatibility, flexibility, electrical insulation, etc.). It is clear that the primary electrode 2 and the secondary electrode 3 and the electrical conductor 4 are embedded in the carrier material 6. It is also clear that the electrical conductor 4 of the secondary electrode 3 at the rear away from the connecting element 5 is arranged around the primary electrode 1 in a corrugated shape, wherein this corrugated arrangement extends on a curved track around the primary electrode 2. In this way, the load on the electrical conductor 4 can be reduced, and thus the failure probability of the secondary electrode 3 can also be reduced. The electrical conductor 4 is connected to the secondary electrode 3 via a connection point, wherein the connection point is a tangential conductor connection 7. The electrical conductor 4 can be soldered or welded to the secondary electrode 3, wherein it is advantageous that the connection point is sealed, for example, with epoxy resin to protect it from external influences.

[0098] A reinforcing element 8 in the form of a surgical mesh is arranged on the electrode arrangement 1, wherein the reinforcing element 8 is drawn between the outer layers of the carrier material. The reinforcing element 8 is arranged between the primary electrode 2 and the secondary electrode 3 in order to improve the tensile strength.

[0099] It can be seen that the connecting element 5 is arranged on the contact section 9, wherein the contact section 9 protrudes laterally from the electrode arrangement 1 and has a length L that is greater than the width B. The elongated design of the contact section 9 has the advantage that the connecting element 5 is decoupled from the primary electrode 2 and the secondary electrode 3, wherein forces acting on the contact section 9 are compensated over the length L of the contact section 9, so that the forces are not transmitted further to the electrode arrangement 1 at all or only very weakly. In order to ensure the flexibility of the contact section 9, it can be advantageous if the reinforcing element 8 is not arranged on the contact section 9 and extends only to the transition region to the contact section 9 or extends into the contact section 9 in a manner similar to a kink protection, tapering.

[0100] The electrode device 1 is set up for implantation, for example, between the scalp and the skull of a living being. Here, the primary electrode 2 and the secondary electrode 3 have a fastening opening 10, wherein an insulating sleeve 11 is respectively inserted into the fastening opening 10. Then, the electrode device 1 can be fixed on the skull of a living being via a fastening element, for example, via a screw through the insulating sleeve 11. The insulating sleeve 11 prevents: excessive torque is transmitted to the primary electrode 2 or the secondary electrode 3, thereby damaging the primary electrode or the secondary electrode. In addition, the undesirable current flow between the electrode (primary electrode 2 and secondary electrode 3) and the fastening element is avoided. The insulating sleeve 11 can be composed of polyetheretherketone, for example. By fixing the electrode device 1 on the corresponding electrode (primary electrode 2 and secondary electrode 3) via the fastening opening 10, the precise orientation of the electrode can be ensured, which can generate a desired electric field in the target area. It can also be recognized that two fastening elements 12 are provided on the contact section 9 for screw fastening on the living being. The contact section 9 can be fixed to the skull of a living being via the fastening element 12 .

[0101] It is clear that the electrode arrangement 1 has a cutout 13 between the secondary electrodes 3. The cutout 13 increases the flexibility of the electrode arrangement 1, in particular in the region of the secondary electrodes 3. Since the bones of a living being are usually not flat, but the electrodes (primary electrode 2 and secondary electrode 3) must be positioned precisely on the bones, it is advantageous that the flexibility of the electrode arrangement 1 is correspondingly high, so that the electrodes 2, 3 can be fixed accordingly near the bones and the electrode arrangement 1 can be well adapted to the shape of the bones.

[0102] Figure 7 The schematic diagram shows a primary electrode 2 and a secondary electrode 3 in a carrier material 6 in a side view. It can be seen that the primary electrode 2 and the secondary electrode 3 each have a continuous fastening opening 10, wherein an insulating sleeve 11 is arranged in the fastening opening 10, and wherein the electrode arrangement 1 can be fixed to a bone or tissue structure of a living being by means of a fastening element via the insulating sleeve 11.

[0103] It is clear that the carrier material 6 has a first circumferential sealing lip 14 on the exposed contact side 15 of the secondary electrode 3. The circumferential sealing lip 14 can be formed in one piece from the same material as the carrier material 6. In this way, the electrode device 1 can be fixed at the site to be implanted, although it is not flat, without deformation at the secondary electrode 3. It is also conceivable that the circumferential sealing lip 14 partially extends beyond the secondary electrode 3, so that an improved fixation of the secondary electrode 3 in the carrier material 6 can be achieved. In addition, it can be seen that the secondary electrode 3 is exposed on the contact side 15 and is covered by the carrier material 6 in an insulating manner on the other side. Therefore, the secondary electrode 3 is embedded in the carrier material 6. This can achieve effective insulation of the secondary electrode 3 to the outside and at the same time ensure that the desired electric field is generated in the body area facing the contact side 15. It is also conceivable that the insulating material sleeve 11 has a circumferential second sealing lip 17, which also contributes to this effect. Advantageously, all electrodes of the electrode device 1 have such a structure.

[0104] Figure 8 A method for producing an electrode arrangement for electrical stimulation of biological tissue, in particular a method for producing an electrode arrangement 1 according to the above-described features, is schematically shown.

[0105] In method step a), the electrode body 20 is produced from a film of electrode material with a suitable thickness by stamping or blanking, for example by laser stamping or blanking. In optional method step b), a surface coating and / or a surface structured portion is applied to at least a portion of the electrode surface. In method step c), an electrical conductor 4 is applied to each electrode body 20. In optional method step d), epoxy resin or another electrical insulator is applied to the connection point. In method step e), the shape of the electrode device 1 is cast from a carrier material 6. In method step f), the electrode body 20 and optionally the electrical conductor 40 and optionally the reinforcing element 8 are embedded. In method step g), the electrical conductor 4 is connected to the contact section 9 of the electrode device 1.

[0106] Fig. 9 Another method for producing an electrode device 1 for electrically stimulating biological tissue, in particular a method for producing an electrode device 1 according to the above-mentioned features, is schematically shown. In method step a), a carrier material 6 is provided. In method step b), one or more electrode bodies 20 are produced on the carrier material 6 by a vapor deposition process and / or by electrodeposition. In an optional method step c), a surface coating and / or a surface structured portion is applied to at least a portion of the electrode surface. In an optional method step d), the carrier material 6 is embedded in another insulating carrier material.

[0107] The drawings are to be understood as realizable embodiments. Other forms of teaching according to the invention are also conceivable. Furthermore, the configurations of the embodiments are not inseparably connected to one another, so that, for example, the implementation of the invention is not relevant to the specifically described configurations of the embodiments. Thus, variability, for example, in the number or in the installation of individual elements, such as the primary electrode 2, the secondary electrode 3, the cutout 13 and / or the recess 16, can be considered at any time.

Claims

1. An electrode body (20) of an electrode device for electrically stimulating tissue of a living being, wherein the electrode body (20) is configured to be arranged at a location between a skull and a scalp of the living being, and wherein the electrode body (20) has a stimulation surface, which is configured to be in contact with the tissue of the living being so as to generate electrical stimulation to the tissue by means of alternating current pulses and / or direct current pulses, It is characterized in that The electrode body (20) has grooves (16) which are arranged distributed over the circumference and are used to fix the electrode body (20) in the carrier material (6). The electrode body (20) has a fixing structure for fixing the electrode body (20) to biological tissue, wherein the fixing structure has an insulating material sleeve (11) which is designed to insulate a mechanical fastening element relative to the electrode body (20).

2. The electrode body (20) according to claim 1, It is characterized in that The electrode arrangement is used for nerve stimulation.

3. The electrode body (20) according to claim 1 or 2, It is characterized in that The electrode body (20) has a conductor connection portion (7), via which the electrode body (20) can be connected to an electrical conductor (4) by soldering, bonding or welding, for electrically connecting the electrode body (20) to an electrical device or another electrode body (20).

4. The electrode body (20) according to claim 3, It is characterized in that The conductor connection (7) is designed as a tangential or right-angled conductor connection (7).

5. The electrode body (20) according to claim 3, It is characterized in that An electrical conductor (4) is connected to the conductor connection (7) for electrically connecting the electrode body (20) to an electrical device or another electrode body (20), wherein the electrical conductor (4) extends in a corrugated manner.

6. The electrode body (20) according to claim 1 or 2, It is characterized in that The fixing structure has at least one fastening opening (10) in the electrode body (20), and the electrode body (20) can be fixed to the tissue of the organism through the fastening opening by the mechanical fastening element.

7. The electrode body (20) according to claim 6, It is characterized in that The mechanical fastening elements are screws, nails, clips or wires.

8. The electrode body (20) according to claim 6, It is characterized in that The insulating material sleeve (11) is arranged in the fastening opening (10).

9. The electrode body (20) according to claim 1 or 2, It is characterized in that The insulating material sleeve (11) has an at least partially circumferential second sealing lip (17).

10. An electrode arrangement (1) for electrically stimulating biological tissue, the electrode arrangement comprising at least one primary electrode (2) and at least one secondary electrode (3), wherein one, more or all of the primary electrodes (2) are each formed by an electrode body (20) and / or one, more or all of the secondary electrodes (3) are each formed by an electrode body (20), wherein the primary electrode (2) and the secondary electrode (3) are arranged on a common carrier material (6), It is characterized in that The carrier material (6) has, on the exposed contact side (15) of the electrode body (20), an at least partially circumferential first sealing lip (14), which at least partially protrudes beyond one, several or all primary electrodes (2) and / or at least partially beyond one, several or all secondary electrodes by 0.05 mm to 1 mm.

11. The electrode device (1) according to claim 10, It is characterized in that The electrode device is used for nerve stimulation.

12. The electrode device (1) according to claim 10 or 11, It is characterized in that The first sealing lip (14) at least partially protrudes beyond one, a plurality of or all primary electrodes (2) and / or at least partially protrudes beyond one, a plurality of or all secondary electrodes by 0.1 mm to 0.3 mm.

13. The electrode device (1) according to claim 10 or 11, It is characterized in that A reinforcing element (8) is arranged on the carrier material (6).

14. The electrode device (1) according to claim 13, It is characterized in that The reinforcing element is a reinforcing mesh.

15. The electrode device (1) according to claim 10 or 11, It is characterized in that The at least one primary electrode (2) and the at least one secondary electrode (3) are each connected to a connecting element (5) by means of an electrical conductor (4), wherein the connecting element (5) is designed for connection to a further electrode or an energy source (21).

16. The electrode device (1) according to claim 15, It is characterized in that At least one of the electrical conductors (4) is at least partially surrounded by the carrier material (6).

17. The electrode device (1) according to claim 15, It is characterized in that At least one electrical conductor (4) of the secondary electrode (3) is arranged in a corrugated manner around the primary electrode (2), wherein the corrugated arrangement of the electrical conductor (4) runs along a curved path around the primary electrode (2).

18. The electrode device (1) according to claim 15, It is characterized in that The electrode arrangement (1) has a contact section (9), wherein the connecting element (5) is arranged on the contact section (9), and wherein the contact section (9) protrudes laterally from the electrode arrangement (1).

19. The electrode device (1) according to claim 18, It is characterized in that A fastening element (12) for screw fastening is arranged on the contact section (9).

20. The electrode device (1) according to claim 10 or 11, It is characterized in that The secondary electrode (3) is arranged on at least one circular track around the primary electrode (2).

21. A method for producing an electrode device (1) for electrically stimulating biological tissue, Features The method comprises the following steps: a) producing an electrode body (20) from a film of electrode material having a suitable thickness, c) producing recesses in the electrode body (20) which are arranged distributed over the circumference in order to fix the electrode body (20) in the carrier material (6); d) applying or producing one electrical conductor (4) on each electrode body (20), f) casting the shape of the electrode arrangement (1) from the carrier material (6), g) embedding the electrode body (20) and possibly the electrical conductor (4), and possibly the reinforcing element (8), h) connecting an electrical conductor (4) to a contact section (9) of the electrode arrangement (1), i) Providing an electrode body (20) having a fixing structure for fixing the electrode body (20) to biological tissue, wherein the fixing structure has an insulating material sleeve (11) which is designed to insulate a mechanical fastening element relative to the electrode body (20).

22. The method according to claim 21, Features The method further comprises the following steps: b) Applying a surface coating and / or a surface structuring to at least a part of the electrode surface.

23. The method according to claim 21, Features The method further comprises the following steps: e) Apply epoxy resin to the connection points.

24. The method according to claim 21, It is characterized in that The method is a method for producing an electrode arrangement (1) according to any one of claims 10 to 20.

25. The method according to claim 21 or 22, It is characterized in that The electrode body (20) is manufactured by laser cutting.

26. A method for manufacturing an electrode device (1) for electrically stimulating biological tissue according to any one of claims 10 to 20, Features The method comprises the following steps: a) providing a carrier material (6), b) producing one or more electrode bodies (20) on the support material (6) by a vapor deposition process and / or by electrodeposition.

27. The method according to claim 26, Features The method further comprises the following steps: c) Applying a surface coating and / or a surface structuring to at least a part of the electrode surface.

28. The method according to claim 26, Features The method further comprises the following steps: d) embedding the carrier material (6) in another insulating carrier material.

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