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：本发明涉及一种用于施加在人的皮肤上的电极,所述电极具有不导电的载体(1),所述载体在该载体的背离皮肤的上侧上具有突出的导电的接线元件(2),所述接线元件具有用于可脱开地连接信号导体的接线位置(2a),其中,设有至少部分设置在所述载体(1)的相对置的下侧上的导体(3),所述导体与接线元件(2)以及与面向皮肤的接触介质(4)处于电连接中,其中,所述接线元件(2)具有穿过所述载体(1)的至少一个突出部(2b),所述至少一个突出部在其端部处具有通过成型形成的扩展的区域(BZ),其中,通过该成型的扩展的区域(BZ),一方面能够在导体(3)与接线元件(2a)之间建立电连接,并且另一方面能建立接线元件(2)在载体(1)上的机械式的固定。(The invention relates to an electrode for application to the skin of a person, comprising a non-conductive carrier (1) which, on the upper side thereof facing away from the skin, has a projecting, electrically conductive terminal element (2) having terminal points (2a) for detachably connecting signal conductors, wherein conductors (3) are provided which are arranged at least partially on the opposite lower side of the carrier (1) and are electrically connected to the terminal element (2) and to a contact medium (4) facing the skin, wherein the terminal element (2) has at least one projection (2b) which passes through the carrier (1) and which has an expanded region (BZ) formed by shaping at the end thereof, wherein, on the one hand, an electrical connection can be established between the conductor (3) and the terminal element (2a) by means of the shaped expanded region (BZ), and on the other hand, a mechanical fixing of the connection element (2) to the carrier (1) can be established.)

1. An electrode for application to the skin of a person, having a non-conductive carrier (1) which, on its upper side facing away from the skin, has a projecting, electrically conductive terminal element (2) with terminal locations (2a) for detachably connecting signal conductors, wherein conductors (3) are provided which are arranged at least partially on the opposite lower side of the carrier (1) and are electrically connected to the terminal element (2) and to a contact medium (4) facing the skin, characterized in that the terminal element (2) has at least one projection (2b) which passes through the carrier (1) and which has an expanded region (BZ) formed by shaping at its end, wherein, by means of the shaped expanded region (BZ), on the one hand an electrical connection can be established between the conductor (3) and the terminal element (2a), and on the other hand, a mechanical fixing of the connection element (2) to the carrier (1) can be established.

2. Electrode according to claim 1, characterized in that the wiring element (2) is made of one single part with wiring positions (2a) for releasable connection of signal lines.

3. The electrode according to claim 1 or 2, characterized in that the wiring element (2) is made of metal, preferably a deep drawn metal plate, or of an electrically conductive plastic, preferably ABS doped with electrically conductive carbon fibers.

4. The electrode according to any one of claims 1 to 3, characterized in that the wiring element (2) has: a substantially spherical head (2c), a neck (2d) which is connected to the head and which is reduced in diameter, a retaining region (2e) which projects laterally in the form of a flange and which is connected to the end of the neck (2d), and at least one projection (2b) which is connected to the retaining region (2 e).

5. The electrode according to any one of claims 1 to 4, characterized in that the at least one projection (2b) is formed by at least one first section (5) and at least one second section (6), wherein the at least two sections (5, 6) are preferably located in a horizontal position (H) or in a vertical position (V) in the starting position, or at least one section of the at least two sections (5, 6) is located in a horizontal position (H) and at least one second section of the at least two sections (5, 6) is located in a vertical position (V) and a flange-like holding region (2e) is formed by at least one section of the at least two sections (5, 6).

6. The electrode according to claim 5, characterized in that the at least one projection (2b) is configured as a spike tapering in a direction opposite to the holding region (2 e).

7. The electrode according to claim 4, characterized in that the laterally projecting flange-like holding region (2e) is disk-shaped.

8. The electrode according to one of claims 1 to 7, characterized in that the connection element (2) has at least two wing sections (9), wherein the at least two wing sections (9) have a section (9a) which is inclined with respect to a horizontal position (H), wherein each wing section forms a projection (2b) and a laterally projecting flange-like holding region (2e), wherein preferably the at least two wing sections (9) are at least in sections configured as sharp-edged.

9. The electrode according to any one of claims 1 to 8, characterized in that the wiring element (2) is constructed substantially rotationally symmetrical overall.

10. The electrode according to any one of claims 1 to 9, characterized in that the conductor (3) is configured as a conductive pad which at least partially protrudes beyond the shaped expanded zone (BZ).

11. The electrode according to any one of claims 1 to 10, characterized in that the conductor (3) is preferably provided, preferably coated, with an electrically conductive material on one side.

12. The electrode according to any one of claims 1 to 11, characterized in that the conductor (3) is configured as a layer made of a first material (3b) which is provided, preferably coated, with a second material (3a) in the region of the contact medium (4), and preferably only there.

13. The electrode according to claim 12, characterized in that the second material (3a) is an electrically conductive material and is made of a pair of silver/silver chloride or tin/tin chloride or other redox couple suitable for depolarizing the electrode, for example.

14. The electrode according to claim 12 or 13, characterized in that the first material (3b) is a plastic, in particular a plastic film.

15. The electrode according to any of claims 12 to 14, characterized in that the first material (3b) has a thickness between 10 μ ι η and 250 μ ι η, preferably between 30 μ ι η and 100 μ ι η, and the second material (3a) has a thickness between 0.05 μ ι η and 30 μ ι η, preferably between 0.1 μ ι η and 3 μ ι η.

16. The electrode according to any one of claims 1 to 15, characterized in that the conductor (3) is formed by a layer made of an electrically conductive material applied, preferably printed, onto the carrier (1).

17. The electrode according to any one of claims 1 to 16, characterized in that the conductor (3) is a metal or metal alloy, or a plastic film that is conducted through or on the surface, for example by conductive carbon fibers, or a fabric material that is conducted through or on the surface.

18. The electrode according to any one of claims 1 to 17, characterized in that the conductor (3) is configured substantially rotationally symmetrical, in particular annular.

19. The electrode according to any one of claims 1 to 17, characterized in that the conductor (3) is configured substantially square.

20. The electrode according to any one of claims 1 to 19, characterized in that the conductor (3) has an opening (8) for introducing a wiring element (2).

21. The electrode according to any one of claims 1 to 20, characterized in that the wiring element (2) on the one hand and the contact medium (4) on the other hand are arranged on the carrier (1) at positions laterally offset from one another.

22. The electrode according to any one of claims 1 to 21, 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, a binder configured to be conductive or a sponge configured to be filled with a salt solution.

23. The electrode according to one of claims 1 to 22, characterized in that the connection element (2) is connected to the carrier (1) on the underside and on the upper side thereof, preferably with a flat conductor (3) connected in between.

24. The electrode according to any of claims 1 to 23, characterized in that a paste layer (7) is provided on the underside of the electrode facing away from the skin, wherein the paste layer (7) can be adhered to the skin, preferably by means of a coating of biocompatible adhesive material on the patient side, in order to fix the electrode.

25. Electrode according to claim 24, characterized in that the paste layer (7) is bonded to the carrier (1) via a layer made of a self-adhesive or of a heat-activatable adhesive applied to the paste layer or the carrier (1).

26. The electrode according to any one of claims 1 to 25, characterized in that the carrier (1) is made of a film, in particular of PET.

27. The electrode according to any one of claims 1 to 26, characterized in that the carrier (1) is coated on the side facing the skin with an adhesive material, preferably a skin adhesive, which is preferably embodied self-adhesive or thermally activatable, or has a paste layer (7) provided with an adhesive material, preferably a skin adhesive, on the side facing the skin.

28. The electrode according to any one of claims 1 to 27, characterized in that the carrier (1) has at least one cutout in the area next to the wiring element (2), which cutout allows mobility of the wiring element (2) relative to the layer of paste provided for adhesion to the skin.

29. The electrode according to any of claims 1 to 28, characterized in that the conductor (3) and the contact medium (4) are formed by separate components and preferably made of different materials (fig. 1 to 17 b).

30. The electrode according to any of claims 1 to 28, characterized in that the conductor (3) and the contact medium (4) are formed by the same member, preferably by an electrically conductive adhesive (fig. 18 to 23), with which the electrode can be adhered to the skin of a patient.

31. The electrode according to any one of claims 1 to 30, characterized in that the wiring element (2), the conductor (3) and/or the contact medium (4) are made of or contain, at least in sections, a pair of silver/silver chloride, tin/tin chloride or other redox couple, for example suitable for depolarizing the electrode.

32. Method for manufacturing an electrode for application on the skin of a person, in particular according to any one of claims 1 to 31, characterized in that:

-arranging, preferably gluing or printing, the conductor (3) on the lower, skin-facing side of the non-conductive carrier (1),

-introducing a wiring element (2) through the carrier (1) from the upper side thereof such that the projections (2b) of the wiring element (2) project on the opposite lower side of the carrier (1) and the wiring element (2), preferably with a laterally projecting disc-shaped holding region (2e), rests on the upper side of the carrier (1),

-shaping the projection (2b) of the terminal element (2) so as to produce a shaped extended region (BZ) which on the one hand establishes an electrically conductive connection between the terminal element (2) and the conductor (3) and on the other hand establishes a mechanical fixing of the terminal element (2) on the carrier (1).

33. Method according to claim 32, characterized in that the through-going openings (8) through the carrier (1) and the conductors (3) are made before introducing the terminal elements (2), preferably by punching.

34. Method according to claim 32, characterized in that the through-going opening (8) is made by penetrating the carrier (1) and the conductor (3) from the side of the carrier (1) facing away from the skin by means of a tapering projection (2 b).

35. Method according to any one of claims 32 to 34, characterized in that the wiring element (1) is introduced by rotating the wiring element (1) into the carrier (1) and the conductive pad (3) from the upper side of the carrier, such that the wing section (9) passes through the carrier (1) and the conductive pad (3).

36. Method according to any one of claims 32 to 35, characterized in that the shaping of the protrusion (2b) is carried out by:

-melting the protrusion (2b), and/or

-flanging the projection (2b), and/or

-deploying the projection (2b), and/or

-bending the protrusion (2 b).

37. A method according to any one of claims 32 to 36, wherein there is 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 as to make contact with the conductor (3) located therebelow.

38. Method according to one of claims 32 to 37, characterized in that the carrier (1) is coated over the whole or part of its surface with an adhesive material, preferably a skin adhesive, before the introduction of the terminal element (2).

39. Method according to claim 38, characterized in that after coating the carrier (1) with an adhesive material, preferably a skin adhesive, an electrical contact medium (4) is applied in order to make contact with the conductor (3) located thereunder.

Technical Field

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

Background

Such medical skin electrodes may be used as measuring electrodes, which are capable of deriving electrical signals from the human body. The skin electrode may also be used as a treatment electrode to deliver current to the body. For this purpose, the electrode is adhesively bonded to the skin and usually has an electrically conductive gel or other electrical contact medium on its underside, which is in galvanic contact with the connecting element of the electrode. An electrical signal conductor can be connected to the connection element, via which an electrical current can be conducted from the electrode or to the electrode.

One type of electrode has a protruding, electrically conductive terminal element on the upper side facing away from the skin, which has a generally substantially spherical terminal location to which the neck is connected.

In previous designs of this type of electrode, the connecting element is designed in two parts. The upper part (top button, column) is used for contact and anchoring elements of commercially available signal conductors, such as electrocardiographs. Essentially below the carrier, i.e. on the side facing the skin, a lower button portion (eyelet member) is used to receive or transfer an electrical potential directly from or to the gel (contact medium). In this case, the eyelet is not only electrically conductive but also mechanically connected to the column, more precisely, usually by riveting the two parts together, so that the carrier material of the electrode is firmly clamped between the flange-like projecting holding region of the column and the same holding region of the eyelet. Such a structure on the one hand provides good mechanical retention of the connection element on the carrier of the electrode and on the other hand allows the eyelet to be manufactured from a material which has electrically advantageous properties for the signal electrode, for which purpose the eyelet is coated with silver, wherein the silver layer is in turn covered over the entire surface or at least in a partial region in contact with the gel with a layer made of silver/silver chloride (Ag/AgCl). There is also the possibility that the eyelet members do not directly contact the gel. Transverse conductors connecting the eyelet members to the gel are then provided in such so-called eccentric electrodes.

However, the electrodes according to the prior art are expensive-wherein even minor price differences are significant in such mass-produced items.

The applicant's own patent document AT519280a1 therefore proposes, instead of the generally customary two-part construction in which the connection element consists of two parts riveted to one another (post and eyelet), a single part now being provided as the connection element, which on the one hand provides a connection point for the detachable connection of the signal conductors and on the other hand is in connection (preferably electrically conductive) with the electrical transverse conductors.

However, such a one-piece construction of the terminal element still has some disadvantages.

For example, an additional support layer is required in order to adequately fix the terminal element to the carrier. This affects on the one hand the material requirements of the electrode and also the length of time the electrode is manufactured.

However, the material requirements and the length of time for manufacturing the electrode are decisive for the manufacturing costs of such electrodes. Therefore, it is desirable to keep the material requirements and the length of time the electrode is manufactured as low as possible.

Disclosure of Invention

It is therefore the object of the present invention to provide an electrode which is improved with respect to the electrodes disclosed in patent document AT519280a1, in particular with respect to production costs and production times, and a method for producing such an electrode.

According to the invention, this is achieved by an electrode according to claim 1 and a method according to claim 32.

It is therefore provided that the terminal element has at least one projection which passes through the carrier and has an expanded region formed by shaping at its end, wherein by means of such a shaped expanded region, on the one hand an electrical connection between the conductor and the terminal element and, on the other hand, a mechanical fixing of the terminal element to the carrier can be established.

This not only reduces the material requirements but also reduces the production time of the electrode.

It is also advantageous if the connecting element is connected to the carrier and/or the conductor not only in a form-fitting manner but also in a force-fitting manner via the expanded region formed by the shaping.

In a particularly advantageous manner, it can be provided that the connection element is made of a single component which has connection points for the detachable connection of signal lines.

The terminal element itself can be produced entirely from various materials, for example nickel-plated brass or plastic with conductive materials, in particular carbon fibers.

Particularly preferred is a configuration of the terminal element, wherein the terminal element is configured such that it has a substantially spherical head, a neck which is reduced in 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 which is connected to the retaining region.

The projection is guided (preferably without lateral contact) through an opening in the carrier, while the flange-shaped laterally projecting holding region rests on the upper side of the carrier. The holding region, which projects laterally in the form of a flange and is expanded in diameter, holds the connecting element securely on the carrier material even under high compressive loads.

The shaped, expanded region of the projection of the holding element bears against the underside of the carrier facing the skin or against the conductor and thus also ensures that the terminal element is held on the carrier in the event of a pressure load on the terminal element.

It can also be provided that the at least one projection is composed of at least one first section and at least one second section, wherein the two sections are located in a horizontal position or in a vertical position in the starting position, or at least one of the at least two sections is located in a horizontal position and at least one second section of the at least two sections is located in a vertical position, and the holding region is formed by at least one of the at least two sections.

In this embodiment of the invention, the shaping of the shapeable region may be performed by simply bending at least one of the at least two segments.

According to a further embodiment of the invention, it can be provided that the laterally projecting flange-like holding region is composed of at least two wing segments, wherein the at least two wing segments have a section which is inclined with respect to the horizontal position and the projection is formed by the at least two wing segments, wherein preferably the at least two wing segments are at least in sections embodied as sharp-edged.

The at least two wing sections can be configured to be identical or non-identical. In the latter case, in particular, the inclined sections can be of different lengths.

In such an embodiment, it is possible to introduce the connection element into the carrier or the conductor without previously producing a through-opening through the carrier and the conductor by combining a rotating and pressing movement of the connection element on the upper side of the conductor. At least one of the at least two inclined sections can be deformed by simply bending in the direction of the underside of the carrier.

This makes it easier to pass through the carrier and the conductor if the wing section sections are configured to be sharp-edged.

In a further embodiment of the invention, it is provided that the at least one projection is designed as a barb which tapers in the opposite direction to the retaining region. It is thereby possible to introduce the connecting element into the carrier or the conductor without previously producing a through-opening through the carrier and the conductor. Thus saving work steps.

No high demands are put on the electrical properties of the line elements under the subject of the invention. The terminal element can therefore be produced from a cost-effective material, for example from a simple metal sheet. I.e. the connection element, need not have special electrical properties, since only the conductors, which are in connection with the electrical contact medium, may have these electrical properties which are advantageous for the bioelectrode.

The conductor can in principle have any desired geometry, however, in a preferred embodiment of the invention, the conductor can be designed as a rotationally symmetrical or substantially square conductive pad. The conductive pad can project at least partially over the shaped expanded region.

In order to achieve low noise and depolarization in defibrillation situations in the electrodes, redox couples are currently used. The redox couple may be oxidized or reduced and at this time absorb at least one electron or emit at least one electron. Currently, the most different substances are used for such depolarization. Silver/silver chloride and tin/tin chloride are most commonly used. However, for the present invention, all redox couples capable of effecting depolarization of the electrodes are contemplated. The redox couple can be actively added or possibly generated in situ by the reaction.

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

One can further save costs by the measure that the conductor is preferably provided with an electrically conductive material on one side. I.e. the actual conductor may use a cost-effective material, such as metal or plastic, while at the transition region to the electrical contact medium (in particular gel) critical for the advantageous electrical properties of the bioelectrode, a conductive second material, such as silver/silver chloride, may be used. It is sufficient that such material is only locally present in this region.

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

Overall, the basic concept of the invention is to design the terminal element for the signal conductor in such a way that it is well anchored in the electrode, while the electrical properties are less important and therefore cost-effective materials can be used.

On the other hand, expensive materials for providing advantageous electrical signal lines can be used only in electrically critical regions at the transition to the electrical contact medium (gel). The conductor takes over this task. In short, it can be said that the conductive wiring elements are mainly responsible for "mechanics" in addition to the basic characteristics of the wire. For conductors, the situation is reversed: the conductor does not need to satisfy special mechanical properties and is made of a material that is advantageous for this purpose only in the region of the transition to the electrical contact medium (gel). In this connection, the transverse conductor is responsible for "electricity" without special mechanical tasks.

Drawings

Further advantages and details of the invention are set forth in more detail in the description of the figures that follows. In the drawings:

figure 1 shows a schematic bottom view (subsequently the skin-facing side) of an embodiment of an electrode according to the invention up to the manufacturing steps of the finished electrode,

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

fig. 3 shows a sequence of sections according to the line a-a in fig. 1, wherein, for better visualization, the representation can be understood as a schematic representation,

figure 4 shows a schematic bottom view (subsequently the skin-facing side) of the manufacturing steps up to the finished electrode according to another embodiment of the electrode according to the invention,

fig. 5 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. 6 shows a sequence of sections according to line a-a of fig. 4, wherein, for better visualization, the representation can be understood as a schematic representation,

figure 7 shows a schematic bottom view (subsequently the skin-facing side) of the manufacturing steps up to the finished 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 a sequence of sections according to the line a-a of fig. 7, wherein, for better visualization, the representation can be understood as a schematic representation,

figure 10 shows a schematic bottom view of an embodiment of a carrier according to the invention together with a layer of adhesive material,

figure 11 shows a schematic bottom view of another embodiment of a carrier according to the invention together with a layer of adhesive material,

figure 12a shows a schematic side view of an embodiment of a wire connecting element according to the invention,

figure 12b shows a schematic top view of an embodiment of a terminal element according to the invention,

figure 13a shows a schematic side view of the anchoring process of a wire connection element according to the invention in a carrier,

figure 13b shows a schematic top view of the anchoring process of the wiring element according to the invention in the carrier (the side subsequently facing away from the skin),

figure 14a shows a schematic view of another embodiment of a terminal element according to the invention,

figure 14b shows a schematic view of another embodiment of a terminal element according to the invention,

figure 15a shows a schematic side view of another embodiment of a terminal element according to the invention,

figure 15b shows a schematic top view of another embodiment of a terminal element according to the invention,

figure 16a shows a schematic side view of another embodiment of a terminal element according to the invention,

figure 16b shows a schematic top view of another embodiment of a terminal element according to the invention,

figure 17a shows a schematic side view of another embodiment of a terminal element according to the invention,

figure 17b shows a schematic top view of another embodiment of a terminal element according to the invention,

figure 18 shows a schematic bottom view (subsequently the skin-facing side) of the manufacturing steps up to the finished electrode according to another embodiment of the electrode according to the invention,

figure 19 shows a schematic top view of the various manufacturing steps,

figure 20 shows the sequence according to figures 18 and 19 in a sectional view,

fig. 21, 22 and 23 show similar illustrations as in fig. 18, 19 and 20, however for further embodiments.

Detailed Description

A method flow for manufacturing an embodiment of an electrode for application on the skin of a person according to the invention is now set forth in more detail with reference to fig. 1 to 3.

The starting point is a non-conductive support 1. The carrier material serves to anchor the electrical components of the electrode. The carrier material can be made, for example, of a (flexible) film (for example made of PET or TPU) which is completely or partially coated with an adhesive material, which can be embodied as self-adhesive (pressure-sensitive adhesive) or thermally activatable (hot-melt), on the upwardly directed underside in the drawing of fig. 1.

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

In the exemplary embodiment shown, this relates to a circular conductor 3, shown in black or in gray, made of a plastic film. The conductor 3 can also be made of metal or conductive plastic doped with carbon fibres.

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

In a further step, openings 8 are now provided through the electrical conductors 3 and the carrier 1. This can be done, for example, by stamping. Subsequently, a terminal element 2 is introduced, which has a projection 2b projecting from the underside of the carrier 1 and the conductor 3.

In the exemplary embodiment shown, the terminal element 2 has a neck 2d of reduced diameter, which is followed by a substantially spherical head 2c, to which a flange-shaped laterally projecting holding region 2e and a projection 2b are connected.

Overall, the laterally projecting flange-shaped holding region 2e is substantially disk-shaped. The holding area is responsible for distributing and transmitting the pressure applied to the wire connection elements 2 to the carrier 1.

If a terminal element 2 is used which consists of a single part which is connected to the electrical conductor 3 on the one hand and has terminal points 2a for the detachable connection of a signal conductor (not shown here), it is therefore possible to produce the electrode in a cost-effective manner, since the mostly cost-intensive eyelet (lower button) can be dispensed with. The one-piece construction of the terminal element is sufficient for mechanical anchoring.

The requirements on electrical properties are also low. A simple construction, for example a deep-drawn metal part, can thus be used as the connecting element 2. The more difficult electrical task is therefore not taken over by the eyelet (lower button) which is otherwise customary, but by the conductor 3 which is in connection with the later-applied electrical contact medium 4 (gel).

Thus, separation of tasks is performed. Apart from the basic property of electrical conduction, the electrical connection element 2 is essentially responsible for mechanical retention in the electrode, while the conductor 3 is largely free of mechanical tasks. This allows for an advantageous choice of materials. It is possible in particular to provide more expensive, advantageous from an electrical point of view, materials only at the location of the subsequent contact with the gel (location 3 a).

The electrically conductive connecting element 2 can, as already mentioned, be produced from a deep-drawn metal sheet. The terminal element is then at least partially hollow inside. However, the terminal element can also be made of an electrically conductive plastic, for example ABS doped with electrically conductive carbon fibers.

Advantageously, one configures the terminal element substantially rotationally symmetrical. Other variants are also possible.

In order to finally fix the electrical connection element 2 in the electrode and in particular also to prevent tensile loading, the projection 2b is molded in a next step, so that a molded, expanded region BZ is produced.

Here, the protruding portion 2b may be formed by melting, hemming, spreading, or bending. But every other suitable method is also usable.

By shaping the projection 2b, a current-conducting connection is established between the connection element 2 and the electrically conductive material 3a of the conductor 3 via the shaped extended region BZ, and on the other hand a mechanical fixing of the connection element 2 on the carrier 1 is established by means of a form-locking connection and/or a material-locking connection.

Now, a layer of plaster 7 is applied, in particular adhesively bonded, to the underside of the carrier 1, wherein said layer of plaster can be adhesively bonded to the skin, preferably by means of a patient-side coating made of a biocompatible adhesive material, in order to fix the electrode.

In this case, it is also possible for the paste layer to be bonded to the carrier 1 via a layer of a self-adhesive or a heat-activatable adhesive applied to the paste layer.

The paste material is finally used to fix the electrode to the patient's skin. Suitable paste materials may include, for example, films (e.g., PE), foam tapes (e.g., PE foam), or non-woven fabrics. The paste material is typically 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 it in the paste material 7. The electrical contact medium 4 enables (preferably on an ionic basis) the conduction of body-generated potentials or device-generated measuring or stimulating currents from the body surface (skin) to the electrical connection element 2 and vice versa. The contact medium 4 can be made, for example, of a chloride-doped gel which is present more or less in liquid form (more or less gelly) or as a crosslinked polymer matrix (hydrogel). However, it is also possible to generate the electrical contact medium 4 in other ways, for example as a conductive adhesive or as a sponge filled with a salt solution.

In each case, an electrical contact medium 4 is introduced into the interstices of the paste material 7, as shown in the last step of fig. 1 to 3. The contact medium contacts the electrically conductive material 3a (in particular silver/silver chloride) there.

The interaction of the electrically conductive material 3a, in particular a coating with silver/silver chloride or another suitable material on the one hand, with the material of the electrically conductive contact medium 4 on the other hand, allows advantageous electrical properties of the electrode, for example as a noise-free signal transmission or depolarization effect to be achieved, 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 made. This further reduces costs.

Overall, in the production according to fig. 1 to 3, a "central" electrode results, in which the connection element 2 and the contact medium 4 (gel) are arranged directly on top of one another.

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

-arranging, preferably gluing or printing, the conductor (3) on the lower, skin-facing side of the non-conductive carrier (1),

-introducing a wiring element (2) through the carrier (1) from the upper side thereof such that the projections (2b) of the wiring element (2) project on the opposite lower side of the carrier (1) and the wiring element (2), preferably with a laterally projecting disc-shaped holding region (2e), rests on the upper side of the carrier (1),

-shaping the projection (2b) of the terminal element (2) so as to produce a shaped, expanded region (BZ) which on the one hand establishes an electrically conductive connection between the terminal element (2) and the conductor (3) and on the other hand establishes a mechanical fixing of the terminal element (2) on the carrier (1).

Finally, the following steps are then taken to make the electrode:

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

an electrical contact medium 4, preferably a gel, is introduced into the interstices of the paste layer 7, so that contact is made with the conductor 3 located therebelow.

In the exemplary embodiment shown in fig. 4 to 6, most of the method steps correspond to those in fig. 1 to 3, so that the same reference numerals also describe the same components.

The difference is basically that a "central" electrode is provided. That is to say, on the one hand, the contact medium 4 and, on the other hand, the connection elements 2 lie offset from one another in a horizontal plane H.

In such an embodiment, it is necessary to provide an electrically conductive transverse conductor 10, which establishes a connection for the electrical current between the conductor 3 and the terminal element 2.

In the molding of the projections 2b, pressure can be applied to the layers so that they are correspondingly profiled and connected to one another. However, the cross section shown in fig. 6 after the application of the paste layer 7 together with the edges shown there can only be regarded as a schematic illustration. In practice, the layer thicknesses are mostly smaller and the stretching of the layers is considerably more rounded.

Furthermore, it can be seen that the modified expanded region BZ is no longer of circular design, but rather is of sheet-like design. However, the extended region BZ of the variant 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, and therefore, like reference numerals also describe like 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. Thus, the paste layer 7 can be omitted and additional process steps can be saved.

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

Fig. 10 and 11 show the above-described variant for applying the adhesive material 11.

In fig. 10, the adhesive material 11 is already present on the carrier 1 or is applied before the application of the conductors 3. Here, the conductor 3 is then applied to the layer of adhesive material 11. The conductor 3 can be held by the adhesive layer 11, so that no additional adhesion of the conductor 3 to the carrier 1 is required.

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, since the notch 11a is provided, the conductor 3 is not covered with the adhesive material 11.

Fig. 12a and 12b show an embodiment of a terminal element 2 according to the invention. It can be seen that the terminal element 2 has a wing section 9 which forms both a projection and also a holding region of the terminal element 2. The wing segment sections 9a inclined in relation to the horizontal position H can be of the same length or of different lengths. It is also conceivable for the wing segments 9 to be at least sectionally sharp-edged in order to facilitate the passage through the carrier 1 and the conductor 3.

Fig. 13a and 13b show schematic views of the anchoring process of the terminal element according to the invention in a carrier, wherein the terminal element 2 is shown in fig. 12a and 12 b.

For this purpose, in a first step, the thread elements 2 are pressed from the upper side of the carrier 1, which is subsequently facing away from the skin, by the carrier 1 and a conductor extrusion 3, not shown, applied to the lower side of the carrier 1. That is to say, the terminal element 2 passes through the carrier 1 and the conductor 3 with the wing-shaped section sections 9 a.

In the next step, the terminal element 2 is rotated in the direction D. This results in an improved anchoring of the terminal element 2 in the carrier 1.

In a final step, the wing-shaped section 9a is bent upwards in a horizontal position H in the direction of the lower side of the carrier 1, thereby clamping the carrier 1 and the conductor 3. Thus, the electrical connection of the connection element 2 to the conductor 3 and the mechanical fixing of the connection element 2 to the carrier 1 are also ensured. However, it is also possible for the wing section to be bent only upward until it is in the horizontal position H.

Fig. 14a shows an embodiment of the terminal element 2, in which the projection 2b is designed as a tapered spike. It is thereby possible to introduce the connecting element 2 into the carrier 1 or the conductor 3 without previously producing a through-opening 8 through the conductor 3 and the carrier 1. Thus saving work steps.

Fig. 14b shows an embodiment of the terminal element 2, in which the two projections 2b are designed as tapered spikes. Any number of projections 2b may be provided. Furthermore, a plurality of projections 2b can also be provided, which are not configured as a thorn. The plurality of projections 2b can be arranged on the terminal element 2 in a rotationally symmetrical or non-rotationally symmetrical manner.

Fig. 15a to 17b show an exemplary embodiment of a terminal element 2, in which the projection and the flange-like holding region of the terminal element 2 are formed by at least one first section 5 and at least one second section 6.

It can also be seen that the second portion 6 is longer than the first portion 5. The segments 5, 6 can also be of equal length, or the segment 5 can be of longer length than the segment 6.

Fig. 15a shows the terminal element in a front view when all the sections 5, 6 are in the horizontal position H. Fig. 15b shows a corresponding top view.

Fig. 16a shows the junction element in a front view when the section 5 is in the horizontal position H and the section 6 is in the vertical position V. Fig. 16b shows a corresponding top view.

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

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

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

In the previous exemplary embodiments according to fig. 1 to 17b, the conductor 3 and the contact medium 4 are formed by separate components and are also preferably made of different materials.

However, it is also possible to produce the conductor 3 and the contact medium 4 from the same component, preferably from an electrically conductive adhesive, as a result of which a component can be saved overall. This is explained in more detail below with respect to fig. 18-23.

In the exemplary embodiment shown in fig. 18 and 20, first of all an opening 18 is provided in the carrier, into which opening the terminal element is pushed and then the region through which it passes is widened by means of shaping. The expanded region BZ then holds the terminal element 2 securely on the carrier, and a layer of an electrically conductive adhesive 12 is then applied, by means of which the electrode produced can be adhered to the skin of the patient. The electrically conductive layer made of the adhesive 12 thus assumes the function of the conductor 3 and the contact medium 4.

In the embodiment shown in fig. 18 and 20, the adhesive 12 is applied over the entire surface of the underside of the carrier 1.

In the embodiment shown in fig. 21 to 23, most of the manufacturing steps are the same as in the example according to fig. 18 and 20. In the next to last step, the electrically conductive adhesive 12 (which takes on the function of the conductor 3 and the contact medium 4) is applied not over the entire surface but locally, as shown in fig. 21, in the form of a strip.

Additionally, in a final step, a likewise viscous paste material 7 with a central opening through which the electrically conductive adhesive remains exposed as a contact medium is applied. Overall, the adhesion to the skin is therefore effected via the adhesive paste material 7 on the one hand and via the electrically conductive adhesive 12 on the other hand. The advantage of the variant according to fig. 21 to 23 is that, due to the excellent adhesion of the viscous paste material 7 and the saving of electrically conductive adhesive in comparison with the full-surface variant according to fig. 18 to 20, an additional structural element, namely the paste material 7, can be dispensed with in the last-mentioned figure.

In embodiments of the invention, in particular, the second layer of the conductor, as described above, may be formed from a silver/silver chloride or tin/tin chloride or other redox couple layer.

However, it is also possible to provide further electrically conductive components with such redox couples, in particular also the contact means 4 and/or the connection element 2. In order to save the use of relatively expensive redox components, not all conductive elements have such redox couples at the same time, although this is theoretically possible. As already mentioned, it is sufficient that the second layer of the conductor 3 is provided with such a redox couple. In principle, it is also possible to save completely redox couples and to specify: neither the wiring element 2, the conductor 3 nor the contact medium 4 comprise such a redox couple.

List of reference numerals

1 vector

2 Wiring element

2a wiring position

2b projection

2c head

2d neck

2e holding area

3 conductor

3a conductive material

3b non-conductive Material

4 contact medium

5 first section

6 second section

7 paste layer

8 opening

9 wing-shaped section

9a wing section

10 transverse conductor

11 adhesive layer (skin adhesive)

11a notch

12 conductive adhesive

H horizontal position

V vertical position

Extended zone of BZ profiling