阅读说明：本技术 电极 (Electrode for electrochemical cell ) 是由 T·库萨 于 2020-04-02 设计创作，主要内容包括：本发明涉及用于施加在人体皮肤上的电极,该电极包括不导电的载体(1),在载体(1)的背向皮肤的上侧上设有突出的导电的连接元件(2),该连接元件包括用于可松脱地连接信号导体的连接点(2a),设有至少部分地设置在载体(1)的相对置的下侧上的导体(3),该导体与连接元件(2)以及与朝向皮肤的接触介质(4)电气连接,导体(3)和接触介质(4)在载体(1)的下侧上设置在连接元件(2)的连接点(2a)之下,优选在中心延伸通过连接元件(2)的、载体(1)上的虚拟法线同样优选在中心延伸通过导体(3)或在导体(3)中的凹槽(8)和接触介质(4)或在接触介质(4)中的凹槽,导体(3)在其表面上、优选在朝向皮肤的表面上至少局部地具有银/氯化银或锌/氯化锌或其他例如适用于对电极进行去极化的氧化还原对,连接元件(2)具有至少一个伸过载体(1)的突出部(2b),该突出部在其端部上具有扩大区域(BZ)；导体(3)至少部分地设置在扩大区域(BZ)与载体(1)之间。(The invention relates to an electrode for application to the skin of a human body, comprising a non-conductive carrier (1), on the upper side of the carrier (1) facing away from the skin, a projecting, electrically conductive connecting element (2) is provided, which comprises connecting points (2a) for the releasable connection of signal conductors, a conductor (3) which is arranged at least partially on the opposite lower side of the carrier (1) and is electrically connected to the connecting element (2) and to a contact medium (4) facing the skin, the conductor (3) and the contact medium (4) being arranged on the lower side of the carrier (1) below the connecting point (2a) of the connecting element (2), preferably a virtual normal line on the carrier (1) running centrally through the connecting element (2), preferably also running centrally through the conductor (3) or a recess (8) in the conductor (3) and the contact medium (4) or a recess in the contact medium (4), the conductor (3) has silver/silver chloride or zinc/zinc chloride or another redox couple suitable for depolarizing the electrode, for example, at least in places on its surface, preferably on the surface facing the skin, the connecting element (2) having at least one projection (2b) which projects beyond the carrier (1) and has an enlarged region (BZ) at its end; the conductor (3) is at least partially arranged between the enlarged region (BZ) and the carrier (1).)

1. Electrode for application to the skin of a human body, comprising a non-conductive carrier (1), on the upper side of the carrier (1) facing away from the skin, a projecting, electrically conductive connection element (2) is provided, which connection element comprises a connection point (2a) for the releasable connection of a signal conductor; a conductor (3) which is arranged at least partially on the opposite lower side of the carrier (1) and which is electrically connected to the connecting element (2) and to a contact medium (4) facing the skin; the conductor (3) and the contact medium (4) are arranged on the underside of the carrier (1) below the connection point (2a) of the connection element (2); a virtual normal line on the carrier (1), which preferably extends centrally through the connecting element (2), likewise preferably centrally through the recess (8) in the conductor (3) or in the conductor (3) and the contact medium (4) or in the contact medium (4); the conductor (3) has silver/silver chloride or zinc/zinc chloride or another redox couple suitable, for example, for depolarizing the electrode, at least in places on its surface, preferably on the surface facing the skin, characterized in that the connecting element (2) has at least one projection (2b) which projects beyond the carrier (1) and has an enlarged region (BZ) at its end; and the conductor (3) is at least partially arranged between the enlarged region (BZ) and the carrier (1).

2. Electrode according to claim 1, characterized in that the side of the conductor (3) facing the contact medium (4) is partly or completely covered by the connection element (2).

3. The electrode according to claim 1 or 2, characterized in that the area of the conductor (3) with silver/silver chloride or zinc/zinc chloride or other redox couple suitable for depolarizing the electrode is in electrical contact with the connection element (2) and/or with the contact medium (4).

4. Electrode according to one of claims 1 to 3, characterized in that the conductor (3) is designed as a layer made of a first material (3b), which layer is provided with an electrically conductive second material (3a), preferably coated with an electrically conductive second material, in the region of the contact medium (4).

5. The electrode according to claim 4, characterized in that the second material (3a) is annularly arranged on the first material (3 b).

6. The electrode according to claim 4, characterized in that the second material (3a) is arranged substantially over the entire surface of the first material (3 b).

7. The electrode according to claim 4, 5 or 6, characterized in that the first material (3b) is a plastic, in particular a plastic film, or the conductor is made of steel, for example; the second material (3a) is preferably silver/silver chloride, zinc/zinc chloride or other redox couple suitable for depolarizing the electrode.

8. The electrode according to one of claims 4 to 7, characterized in that the first material (3b) has a thickness between 10 μm and 250 μm, preferably between 30 μm and 100 μm; the second material (3a) has a thickness between 0.05 μm and 30 μm, preferably between 0.1 μm and 3 μm.

9. The electrode according to one of claims 1 to 8, characterized in that the conductor (3) is formed by a layer made of an electrically conductive material applied, preferably embossed, onto the carrier (1).

10. The electrode according to one of claims 1 to 9, characterized in that the conductor (3) is a metal or a metal alloy, or an artificial membrane guided through or at the surface, for example through conductive carbon fibers, or a textile material guided through or at the surface.

11. The electrode according to one of claims 1 to 10, characterized in that the conductor (3) is substantially rotationally symmetrical, in particular annularly shaped.

12. The electrode according to one of claims 1 to 11, characterized in that the conductor (3) is substantially square-shaped.

13. The electrode according to one of claims 1 to 12, characterized in that the conductor (3) has an opening (8) for introducing the connecting element (2).

14. The electrode according to one of claims 1 to 13, characterized in that the connecting element (2) consists of metal, preferably of deep-drawn sheet metal, or of electrically conductive plastic, preferably of ABS doped with electrically conductive carbon fibers.

15. The electrode according to one of claims 1 to 14, characterized in that the connecting element (2) consists of at least two parts (2 ', 2 "), one of said parts (2') having a connection point (2a) for the releasable connection of a signal line.

16. The electrode according to claim 15, characterized in that the at least two portions of the connecting element (2) consist of the same or at least two different materials.

17. The electrode according to one of claims 1 to 14, characterized in that the connecting element (2) consists of a single part having a connection point (2a) for the releasable connection of a signal line.

18. The electrode according to one of claims 1 to 17, characterized in that the connecting element (2) and/or the conductor (3) and/or the contact medium (4) are substantially rotationally symmetrical overall.

19. The electrode according to one of claims 1 to 18, characterized in that the enlarged region (BZ) is formed by deformation, by means of which deformation the enlarged region (BZ) can establish an electrical connection between the conductor (3) and the connecting element (2a) on the one hand and can form a mechanical fixing of the connecting element (2) on the carrier (1) on the other hand.

20. The electrode according to one of claims 1 to 19, characterized in that the contact medium (4), which is preferably arranged in the interstices of the paste layer (7), is a gel, preferably doped with chloride, configured as an electrically conductive adhesive or as a sponge filled with a salt solution.

21. The electrode according to one of claims 1 to 20, characterized in that the connection element (2) is connected to the carrier (1) on the underside and/or the upper side thereof, preferably with a flat conductor (3) connected in between.

22. The electrode according to one of claims 1 to 21, characterized in that a plaster layer (7) is provided on the underside of the electrode facing away from the skin, the plaster layer (7) being able to be adhered to the skin, preferably by means of a patient-side coating made of a biocompatible adhesive material, in order to fix the electrode.

23. Electrode according to claim 22, characterized in that the paste layer (7) is bonded to the carrier (1) by a layer made of a self-adhesive or a heat-activatable adhesive applied to the paste layer or the carrier (1).

24. The electrode according to one of claims 1 to 23, characterized in that the carrier (1) consists of a film, in particular of polyethylene terephthalate (PET).

25. The electrode according to one of claims 1 to 24, characterized in that the carrier (1) is coated on the skin-facing side with an adhesive material, preferably with a skin adhesive (11), which is preferably configured as self-adhesive or thermally activatable; or has a layer of paste (7) provided with an adhesive material, preferably with a skin adhesive.

26. The electrode according to one of claims 1 to 25, characterized in that the connecting element (2) is free of silver or silver/silver chloride and of zinc or zinc/zinc chloride on its surface and of other redox couples or components thereof, such as are suitable for depolarizing the electrode.

27. The electrode according to one of claims 1 to 26, characterized in that the carrier (1) has at least one cutout in the area beside the connecting element (2), which cutout allows the movability of the connecting element (2) with respect to the layer of paste provided for adhesion to the skin.

28. Method for manufacturing an electrode for application on human skin, in particular according to one of claims 1 to 27, characterized in that:

-providing, preferably gluing or stamping, a conductor (3) on the lower, skin-facing side of the non-conductive carrier (1);

-introducing the connecting element (2) through the carrier (1) such that the projection (2b) of the connecting element (2) projects on the lower or upper side of the carrier (1) and the connecting element (2) rests preferably with a laterally projecting, disk-shaped holding region (2e) on the upper or lower side of the carrier (1);

-anchoring the connection element (2) in the carrier (1) such that an electrically conductive connection between the connection element (2) and the conductor (3) is established and a mechanical fixing of the connection element (2) on the carrier (1) is formed.

29. Method according to claim 28, characterized in that the through-going openings (8) through the carrier (1) and the conductor (3) are made before the introduction of the connection element (2), preferably by punching.

30. Method according to claim 29, characterized in that the anchoring of the connecting element (2) is achieved by deformation of a projection (2b) of the connecting element (2).

31. Method according to claim 30, characterized in that the deformation of the projection (2b) is achieved by:

-melting of the protrusion (2 b); and/or

-crimping of the tab (2 b); and/or

-the divergence of the projections (2 b); and/or

-bending of the projection (2 b).

32. Method according to claim 28, characterized in that the anchoring of the connection element (2) is achieved by a connection, preferably a plug-in connection, of the second part (2 ") of the connection element with the first part (2') of the connection element (2).

33. Method according to one of the claims 28 to 32, characterized by the further step of:

-applying, preferably adhering, a skin-side adhesive plaster layer (7) to the carrier (1);

-introducing an electrical contact medium (4), preferably a gel, into the interstices of the paste layer (7) so that the conductors (3) located below are contacted.

34. Method according to one of claims 28 to 33, characterized in that the carrier (1) is coated over the entire surface or in sections with an adhesive material, preferably a skin adhesive, before the introduction of the connecting element (2).

35. Method according to claim 34, characterized in that the electrical contact medium (4) is applied after the carrier (1) has been coated with an adhesive material (11), preferably a skin adhesive, so that the conductors (3) located underneath are contacted.

Technical Field

The present invention relates to an electrode according to the preamble of claim 1. The invention further relates to a method for producing an electrode.

Background

Such medical skin electrodes may be used as measuring electrodes, which derive electrical signals from the human body. However, such medical skin electrodes may also be used as therapy electrodes for supplying electric current to the human body. For this purpose, the electrodes are glued to the skin and generally have on their underside an electrically conductive gel or other electrical contact medium, which is in electrical contact with the connecting elements of the electrodes. An electrical signal conductor can be connected to the connecting element, via which signal conductor current can be drawn from the electrode or supplied to the electrode.

One type of electrode has a protruding, electrically conductive connecting element on the upper side facing away from the skin, which comprises a mostly substantially bulb-shaped connection point to which the neck is connected.

In previous constructions of electrodes of this type, the connecting element is formed in two parts. The upper part (upper button, Stud) serves as a contact and anchoring element for a commercial standard signal conductor, for example an Electrocardiogram (EKG) line. Essentially below the carrier, i.e. on the side facing the skin, is a lower button (eye) for receiving the potential directly from the gel (contact medium) or for transferring the potential to the gel. The Eyelet is connected to the Stud both electrically and mechanically, more precisely by riveting the two parts, so that the carrier material of the electrode is clamped securely between the flange-like laterally projecting holding region of the Stud and the holding region of the Eyelet, which is also the holding region. Such a design on the one hand provides good mechanical retention of the connecting element on the carrier of the electrode and on the other hand allows the production of the Eyelet from a material having electrically favorable properties for the signal electrode, for example, it is possible to coat this with silver, which in turn is covered over the entire surface or at least in the partial region in contact with the gel with a layer made of silver/silver chloride (Ag/AgCl).

However, the electrodes according to the prior art are expensive, and a small difference in price in such a large-scale product has a great influence.

Furthermore, in the electrodes according to the prior art, the layer made of, for example, silver/silver chloride (Ag/AgCl) is in contact with the contact medium over the entire surface. This results in: from the beginning (initial contact of the contact medium with the silver/silver chloride layer) the silver/silver chloride layer is acted upon by the contact medium. The silver is converted to silver chloride by the contact medium over the entire face of the silver/silver chloride layer. A relatively large amount of silver must therefore be provided in order to ensure the functional capability of the electrode. This in turn leads to high costs in the electrodes according to the prior art.

Disclosure of Invention

It is therefore an object of the present invention to propose an improved electrode and a method for manufacturing such an electrode, in particular avoiding the above-mentioned problems.

According to the invention this is achieved by an electrode according to claim 1 and a method according to claim 28.

It is thus possible to replace the entire Eyelet (end seal element) with an expensive and costly coating of, for example, silver/silver chloride by a conductor which is significantly more cost-effective and can be produced simply.

It can be provided in particular that the side of the conductor facing the contact medium is partially or completely covered by the connecting element.

Whereby only a small part of the silver/silver chloride layer or only its edge layer is in contact with the contact medium. This results in: only this small part of the silver/silver chloride layer or only its edge layer is acted upon by the contact medium and thus at the same time a smaller amount of silver can be converted into silver chloride. This transition occurs only slowly from the contact area of the silver/silver chloride layer to the covered area of the silver/silver chloride layer. It is thus possible to reduce the amount of silver in the silver/silver chloride layer and thus to save further costs.

It can be provided that the connecting element consists of a single part which has a connection point for the releasable connection of the signal lines.

However, it is also possible to provide that the connecting element is composed of at least two parts, one of which has a connection point for the releasable connection of the signal line.

The connecting element itself can be composed of various materials, for example of nickel-plated brass or of plastics doped with electrically conductive materials, in particular carbon fibers.

Particularly preferred is the following configuration of the connecting element: the connecting element is designed in such a way that it has a substantially spherical head, a neck of reduced diameter connected to the head, a retaining region which projects laterally in the form of a flange connected to the end of the neck, and at least one projection connected to the retaining region.

In the case of a one-piece connecting element, the projection (preferably without lateral contact) is guided through an opening in the carrier, while the flange-like holding region projecting laterally rests on the upper side of the carrier. The enlarged-diameter flange-like laterally projecting holding region secures the connecting element to the carrier material even under high pressure loads.

The deformed enlarged region of the projection of the holding element rests against the underside of the carrier facing the skin or against the conductor and thus ensures that the connecting element is held well on the carrier even when a pressure load acts on the connecting element.

In the case of a two-part connecting element, the projection (preferably without lateral contact) is guided through an opening in the carrier, while the flange-like holding region projecting laterally rests on the underside (or upper side) of the carrier. The second part of the connecting element is then arranged on the projection and rests on the upper side (or lower side) of the carrier.

In a further embodiment of the invention, the at least one projection is designed as a spike which tapers in the direction opposite the holding region. It is thereby possible to introduce the connecting element into the carrier or the conductor without previously forming through openings through the conductor and the carrier. Thus saving working steps.

No high demands are made in the context according to the invention on the electrical properties of the connecting element. The connecting element can therefore be composed of a cost-effective material, for example of a simple sheet metal material. The connecting element thus need not have the particular electrical properties, since only the conductor connected to the electrical contact medium can have the electrical properties advantageous for the bioelectrode.

The conductor can in principle have any desired geometric configuration, but in a preferred embodiment of the invention it can be formed as a rotationally symmetrical or substantially square conductor strip. The conductor strip may project at least partially beyond the deformed enlarged region.

In order to achieve small noise and depolarization in defibrillation in the electrodes, redox couples are currently used. The redox couple can be oxidized or reduced and accept at least one electron or emit at least one electron. Currently different substances are used for this depolarization. Silver/silver chloride and zinc/zinc chloride are most often used. However, for the present invention, all redox pairs that can achieve depolarization of the electrodes are contemplated. The redox couple can be actively mixed or generated as far as possible in situ by reaction.

Since, for example, silver/silver chloride is a relatively expensive substance, it is sufficient that: according to a further aspect of the invention, the conductor is preferably provided on one side with an electrically conductive material which is electrically connected to the connecting element and to the contact medium.

Further cost savings are achieved by the provision that the conductors are preferably provided with an electrically conductive material on one side. The actual conductor can thus be made of a cost-effective material, such as, for example, metal or plastic, while a conductive second material, such as, for example, silver/silver chloride, can be used at the transition region to the electrical contact medium (in particular gel), which is critical for the advantageous electrical properties of the bioelectrode. It is sufficient that the material is only present locally in this region.

In particular, the conductor may consist of a plastic film provided with an electrically conductive material.

In general, the invention is based on the following basic idea: the connecting element for the signal conductor is designed such that it is well anchored in the electrode, is less dependent on the electrical properties, and can thus be designed as a cost-effective material.

On the other hand, more expensive materials provided for advantageous electrical signal lines can be used only in electrically critical areas at the transition to the electrical contact medium (gel). The conductor takes over this task. For a very short description it can be said that: the electrically conductive connecting elements are primarily responsible for "mechanics" in addition to the basic properties of the electrical lines. The situation is exactly the opposite in a conductor: the conductor does not need to satisfy special mechanical properties and consists of a material which is advantageous for this purpose only in the region of the transition point to the electrical contact medium (gel). In this regard, the conductor is responsible for "electrical" without special mechanical tasks.

Drawings

Further advantages and details of the invention are further elucidated on the basis of the following description of the drawings. In the drawings:

fig. 1 shows a schematic bottom view (on the subsequent skin-facing side) of the manufacturing steps up to the completed electrode according to one embodiment of the electrode of the invention;

fig. 2 shows a schematic top view of the manufacturing steps up to the finished electrode according to an embodiment of the electrode according to the invention, wherein only a part of the process steps is shown in the top view;

fig. 3 shows the sequence of the individual steps according to line a-a of fig. 1, wherein this view for better visualization is understood as a schematic illustration;

FIG. 4 is cancelled;

FIG. 5 is cancelled;

FIG. 6 is cancelled;

fig. 7 shows a schematic bottom view (on the subsequent skin-facing side) of the manufacturing steps up to the completed electrode according to another embodiment of the electrode according to the invention;

fig. 8 shows a schematic top view of the manufacturing steps up to the finished electrode according to a further exemplary embodiment of the electrode according to the invention, wherein only a part of the process steps is shown in the top view;

fig. 9 shows the sequence of the individual steps according to line a-a of fig. 7, wherein this view for better visualization is understood as a schematic illustration;

FIG. 10 shows a schematic bottom view of one embodiment of a carrier with a layer of adhesive material according to the present invention;

fig. 11 shows a schematic bottom view of another embodiment of a carrier with a layer of adhesive material according to the invention;

FIG. 12a shows a schematic side view of an embodiment of a connecting element according to the invention;

FIG. 12b shows a schematic top view of an embodiment of a connecting element according to the invention;

fig. 13a shows a schematic side view of an anchoring process of a connection element according to the invention in a carrier;

fig. 13b shows a schematic top view of the anchoring process of the connection element according to the invention in a carrier (on the subsequent side facing away from the skin);

fig. 14a shows a schematic view of another embodiment of a connecting element according to the invention;

fig. 14b shows a schematic view of another embodiment of a connecting element according to the invention;

fig. 15a shows a schematic side view of another embodiment of a connecting element according to the invention;

fig. 15b shows a schematic top view of another embodiment of a connecting element according to the invention;

fig. 16a shows a schematic side view of another embodiment of a connecting element according to the invention;

fig. 16b shows a schematic top view of another embodiment of a connecting element according to the invention;

fig. 17a shows a schematic side view of another embodiment of a connecting element according to the invention;

fig. 17b shows a schematic top view of another embodiment of a connecting element according to the invention;

FIG. 18 shows an exploded view of another embodiment having a two-piece connecting element;

fig. 19 shows a schematic bottom view (on the subsequent skin-facing side) of an embodiment of the electrode according to the invention (two-part connecting element) up to the manufacturing step of the finished electrode;

FIG. 20 shows a schematic top view of the manufacturing steps up to a finished electrode according to one embodiment of the electrode of the present invention, wherein only a portion of the process steps are shown in the top view; and

fig. 21 shows the sequence of the individual steps according to line a-a of fig. 18, wherein this view for better visualization is understood as a schematic illustration.

Detailed Description

With reference to fig. 1 to 3, a method flow for manufacturing an embodiment of an electrode for application on human skin according to the invention is now further elucidated.

Here based on a non-conductive carrier 1. The carrier material serves to anchor the electrical components of the electrode. The carrier material can consist, for example, of a (flexible) film (for example of PET or TPU), which is completely or partially coated with an adhesive material on the underside pointing upwards in the drawing of fig. 1, which adhesive material can be designed, for example, as a self-adhesive (pressure-sensitive adhesive) or as a thermally activatable (hot melt adhesive).

In a next step, the rotationally symmetrical conductor 3 is now fixed, in particular glued or stamped, to the carrier material. According to a preferred variant of the invention, the conductor has two different electrically conductive materials or a non-conductive material 3b and an electrically conductive material 3a, wherein the electrically conductive material 3a or one of the two electrically conductive materials is subsequently electrically connected to the electrical connection element 2 and the contact medium 4 (gel).

In the exemplary embodiment shown, this relates to a circular conductor 3 made of plastic film, shown in black or in gray. The conductor 3 may also consist of metal or of a conductive carbon fiber-doped plastic.

In the region of the subsequent contact point with the electrical contact medium 4 (gel), the conductor 3 is coated with a layer 3a made of, for example, silver/silver chloride or zinc/zinc chloride or other redox couple.

In a further step, an opening 8 is now provided through the electrical conductor 3 and the carrier 1. This can be achieved, for example, by stamping. Next, a connecting element 2 is introduced, which has a projection 2b that projects beyond the underside of the carrier 1 and the conductor 3.

In the exemplary embodiment shown, the connecting element 2 then has a substantially spherical head 2c with a neck 2d of reduced diameter, on which a flange-like laterally projecting holding region 2e and a projection 2b are connected.

Overall, the laterally projecting flange-shaped holding region 2e is formed substantially in the shape of a disk. This holding region is responsible for distributing and transmitting the pressure exerted on the connecting element 2 to the carrier 1.

If a connecting element 2 consisting of a single part is used and this part is connected on the one hand to the electrical conductor 3 and on the other hand has a connection point 2a for the releasable connection of a signal conductor (not shown here), then this makes it possible to produce the electrode in a cost-effective manner, since this mostly makes it possible to dispense with the cost-intensive Eyelet (lower button). This one-piece construction of the connecting element is sufficient for mechanical anchoring.

The requirements on the electrical properties are small. This makes it possible to use simple constructions, such as for example the use of deep-drawn metal parts as connecting element 2. The electrical task which is somewhat troublesome here is thus not taken over as before by the Eyelet (lower button) but by the conductor 3, which is connected to the subsequently applied electrical contact medium 4 (gel).

That is to say to achieve a separation of tasks. The electrical connection element 2 is essentially responsible for mechanical retention in the electrode, apart from the basic property of electrical conduction, while the conductor 3 is released as far as possible from the mechanical task. This allows for an advantageous choice of materials. In particular, it is possible that the more expensive, electrically advantageous, material is only provided at the location of the subsequent contact with the gel (point 3 a).

The electrically conductive connecting element 2 can be composed of a deep-drawn sheet metal material, as described above. The connecting element is thus at least partially hollow in the interior. However, the connecting element can also consist of an electrically conductive plastic doped with electrically conductive carbon fibers, for example ABS.

Advantageously, the connecting element is substantially rotationally symmetrical. Other variations are also possible.

In order to finally fix the electrical connection element 2 in the electrode and in particular also to protect it from tensile loads, the projection 2b is deformed in a next step, so that an enlarged region BZ of deformation is formed.

The deformation of the projection 2b can be achieved here by melting, crimping, spreading or bending. But every other suitable method is also usable.

By deforming the projection 2b, the deformed enlarged region BZ establishes an electrical connection between the connecting element 2 and the conductive material 3a of the conductor 3 and, on the other hand, forms a mechanical fixing of the connecting element 2 on the carrier 1 by means of a form-fit and/or force-fit.

A paste layer 7 is now applied, in particular bonded, to the underside of the carrier 1, wherein the paste layer can be bonded to the skin, preferably by means of a patient-side coating made of a biocompatible adhesive material, in order to fix the electrodes.

It is also possible here to bond the paste layer to the carrier 1 via a layer made of a self-adhesive or a heat-activatable adhesive applied to the paste layer.

The paste material is ultimately used to secure the electrode to the patient's skin. Suitable paste materials may consist, for example, of films (e.g. polyethylene PE), foam tapes (e.g. PE foam) or of nonwovens. The paste material is usually coated on the patient side with a biocompatible adhesive material.

In the final production step of the electrode according to fig. 1 to 3, the electrical contact medium 4 is introduced into the recesses provided for this purpose in the paste material 7. The electrical contact medium 4 enables (preferably ionically based) guiding of body-generated potentials or device-generated measured or analog currents from the body surface (skin) to the electrical connection elements 2 and vice versa. The contact medium 4 may, for example, consist of a chloride-doped gel which is present in a more or less liquid form (more or less gel-like) or as a laterally crosslinked polymer matrix (hydrogel). However, it is also possible to produce the electrical contact medium 4 in another medium, for example as an electrically conductive adhesive or as a sponge filled with a salt solution.

In any case, as shown in the last step in fig. 1 to 3, the electrical contact medium 4 is introduced into the voids in the paste material 7. The contact medium contacts therein a conductive material 3a (in particular silver/silver chloride).

The cooperation of the electrically conductive material 3a, in particular with a coating of silver/silver chloride or other suitable material, on the one hand, and the material of the electrically conductive contact medium 4, on the other hand, allows advantageous electrical properties of the electrode to be achieved, such as, for example, a noise-free signal transmission or depolarization effect, wherein the use of the relatively expensive electrically conductive material 3a of the conductor 3 can remain limited to the area in which contact with the contact medium 4 is achieved. This further reduces costs.

Overall, in the production according to fig. 1 to 3, a "central" electrode is produced, in which the connecting element 2 and the contact medium 4 (gel) are arranged directly one above the other.

The method steps which are important for the embodiment according to fig. 1 to 3 are as follows:

-providing, preferably gluing or stamping, a conductor (3) on the lower, skin-facing side of the non-conductive carrier (1);

-introducing the connecting element (2) through the carrier (1) such that the projection (2b) of the connecting element (2) projects on the lower or upper side of the carrier (1) and the connecting element (2) rests preferably with a laterally projecting, disk-shaped holding region (2e) on the upper or lower side of the carrier (1);

-anchoring the connection element (2) in the carrier (1) such that an electrically conductive connection between the connection element (2) and the conductor (3) is established and a mechanical fixing of the connection element (2) on the carrier (1) is formed.

Finally, the following steps are provided for completing the electrode:

-applying, preferably adhering, a skin-side adhesive plaster layer 7 with the carrier 1;

introducing an electrical contact medium 4, preferably a gel, into the interstices of the paste layer 7 so that the conductors 3 located below are contacted.

The deformed expansion zone BZ can also be formed in a non-circular manner, but in a sheet-like manner. The deformed enlargement area BZ can in principle have any arbitrary shape.

In the exemplary embodiment shown in fig. 7 to 9, most of the method steps correspond to those in fig. 1 to 3, so that the same reference numerals also denote the same parts.

The difference is essentially that a layer 11 of biocompatible adhesive material is provided on the carrier 1 for adhering the electrode to the skin of the patient. The paste layer 7 can be omitted and another process step can be saved.

The adhesive material layer 11 can be applied to the carrier 1 before or after the conductor 3 is applied, or the adhesive material layer 11 can already be present on the starting material of the carrier 1.

The above-described variant for applying the adhesive material 11 is shown in fig. 10 and 11.

In fig. 10, the adhesive material 11 is already present on the carrier 1 or the adhesive material 11 is applied before the conductor 3 is applied. The conductor 3 is then applied to the adhesive layer 11. The conductor 3 can be held by the adhesive layer 11, so that the conductor 3 does not have to be additionally bonded to the carrier 1.

In fig. 11, the conductor 3 is applied to the carrier 1 and then the adhesive material 11 is applied to the carrier 1. Here, a recess 11a is provided, so that the conductor 3 is not covered by the adhesive material 11.

Fig. 12a and 12b show an embodiment of a connecting element 2 according to the invention. It can be seen that the connecting element 2 has wing sections 9 which form not only the projections of the connecting element 2 but also the holding regions of the connecting element. The wing segment sections 9a inclined with respect to the horizontal H can be of the same or different lengths. It is also conceivable for the limb segments 9 to be at least partially designed as sharp edges in order to simplify the passage of the carrier 1 and the conductor 3.

Fig. 13a and 13b show schematic views of the anchoring process of the connection element according to the invention in a carrier, which comprises the connection element 2 as shown in fig. 12a and 12 b.

In a first step, the connecting element 2 is pressed for this purpose from the upper side of the carrier 1, which is subsequently facing away from the skin, over the carrier 1 and the conductor 3, not shown, applied to the lower side of the carrier 1. That is, the connecting element 2 passes through the carrier 1 and the conductor 3 with the limb segment section 9 a.

In a next step, the connecting element 2 is rotated in the direction D. This achieves a better anchoring of the connecting element 2 in the carrier 1.

In a final step, the wing segment section 9a is bent beyond the horizontal position H in the direction of the underside of the carrier 1, whereby the clamping of the carrier 1 and the conductor 3 is achieved. This also ensures the electrical connection of the connecting element 2 to the conductor 3 and the mechanical fixing of the connecting element 2 to the carrier 1. However, it is also possible to bend only the wing segment section until it is in the horizontal position H.

Fig. 14a shows an embodiment of the connecting element 2 in which one projection 2b is designed as a tapered barb. It is thereby possible to introduce the connection element 2 into the carrier 1 or the conductor 3 without the through-openings 8 of the through-conductor 3 and the carrier 1 being formed beforehand. Thus saving working steps.

Fig. 14b shows an embodiment of the connecting element 2 in which the two projections 2b are designed as tapered prongs. However, any number of projections 2b may be provided. Furthermore, a plurality of protrusions 2b may be provided, which are not formed in a barbed manner. The plurality of projections 2b can be arranged on the connecting element 2 in a rotationally symmetrical or non-rotationally symmetrical manner.

Fig. 15a to 17b show an embodiment of the connecting element 2 in which the projections and the flanged holding regions of the connecting element 2 are formed by at least one first section 5 and at least one second section 6.

It is also clearly visible that the second section 6 is constructed longer than the first section 5. The segments 5, 6 can also be of the same length, or the segment 5 can be longer than the segment 6.

Fig. 15a shows a front view of the connecting element, wherein all segments 5, 6 are in a horizontal position H. Fig. 15b shows a corresponding top view.

Fig. 16a shows a front view of the connecting element with segment 5 in horizontal position H and segment 6 in vertical position V. Fig. 16b shows a corresponding top view.

Fig. 17a shows a front view of the connecting element, wherein all segments 5, 6 are in a vertical position H. Fig. 17b shows a corresponding top view.

In the connecting element 2 according to fig. 15a and 15b, at least a first section 5 of the at least two sections 5, 6 is transferred into a vertical position V before the connecting element 2 is introduced into the carrier 1, and the at least first section 5 is transferred into a horizontal position H after the connecting element 2 is introduced into the carrier 1.

In the exemplary embodiment of the connecting element 2 according to fig. 17a and 17b, at least the first portion 5 is transferred into the horizontal position H before the connecting element 2 is introduced into the carrier 1, and at least the second portion 6 is transferred into the horizontal position H after the connecting element 2 is introduced into the carrier 1.

Another embodiment shown in fig. 18 relates to a center electrode with a two-part connecting element. The two parts of the connecting element 2 are indicated with 2' and 2 ". For assembly, the two parts 2', 2 ″ of the connecting element 2 are introduced from different sides into the opening 8, the carrier 1 and the conductor 3 and plugged together. The two parts can be simply connected to each other in a clamping manner. But the following possibilities also exist: the two parts 2', 2 "are also connected by other means, for example by clamping together of the necks, by gluing, soldering or welding.

Fig. 18 furthermore shows a virtual normal N extending to the carrier 1, which preferably extends centrally or centrally through the connecting element 2. This virtual normal N preferably also extends centrally through the annularly formed conductor 3 (more precisely, through the opening of the conductor loop) and preferably also centrally through the contact medium 4. In this central electrode, the individual parts, i.e. the connecting element 2, the conductor 3 and the contact medium 4, are thus directly superposed and not laterally offset from one another, preferably not at all, as in fig. 18, or only slightly offset, so that the normal N always also extends through all three parts 2, 3 and 4 (or the openings therein) or is tangent thereto.

In the case of rotational symmetry of the member, "in the center" means extending through the center point. In the case of a non-rotationally symmetrical component, "in the center" denotes the center of gravity extending through the plane of the top view.

In the exemplary embodiment shown in fig. 19 to 21, most of the method steps correspond to those in fig. 1 to 3, so that the same reference numerals also denote the same parts.

The difference is essentially that a two-part connecting element 2 is provided. The first part 2' and the second part 2 "are guided by different sides of the carrier 1 and plugged together.

The lower holding region 2f of the second part 2 ″ of the connecting element 2 thus bears against the carrier 1 or the conductor 3 and thus covers that side of the conductor 3 which subsequently faces the contact medium 4. Furthermore, an electrical connection between the contact element 2 and the conductor 3 is thereby established. This lower holding region 2f corresponds essentially in function to the expanded region BZ of the variant of the previous embodiment.

List of reference numerals

1 vector

2 connecting element

2' first part of connecting element 2

2 "second part of the connecting element 2

2a connection point

2b projection

2c head

2d neck

2e holding area

2f lower holding area

3 conductor

3a conductive material

3b non-conductive Material

4 contact medium

5 first subsection

6 second segment

7 paste layer

8 opening

9 wing segment

9a wing segment

11 adhesive layer (skin adhesive)

11a groove

H level

N normal

V vertical

Enlarged area of BZ deformation