Electrode

Abstract

An electrode for application to human skin, comprising an electrically non-conductive support (1) having on its upper side, directed away from the skin, a projecting electrically conductive connecting element (2) with a connection location (2a) for the releasable connection of a signal conductor, wherein a conductor (3) is provided, said conductor being disposed at least to some extent on the opposite, lower side of the support (1) and electrically connected to the connecting element (2) and to a contact means (4), directed towards the skin, wherein the connecting element (2) has at least one protrusion (2b), extending through the support (1) and, at its end, having a deformed enlarged region (BZ), wherein this deformed enlarged region (BZ) enables, on the one hand, the establishment of an electrical connection between the conductor (3) and the connecting element (2a) and, on the other hand,a mechanical fixing of the connecting element (2) to the support (1).,

Description

[0001] The invention relates to an electrode according to the preamble of claim 1. The invention further relates to a method for manufacturing such an electrode.

[0002] These medical skin electrodes can be used as measuring electrodes to detect electrical signals from the human body. They can also be used as therapeutic electrodes to deliver electrical currents to the body. For this purpose, the electrodes are adhered to the skin and generally have an electrically conductive gel or other contact medium on their underside, which is galvanically connected to a terminal element of the electrode. An electrical signal conductor can be connected to this terminal element, allowing currents to be drawn from or supplied to the electrode.

[0003] One type of electrode has a protruding, electrically conductive connecting element on the upper side facing away from the skin, with a connection point that is usually essentially spherical, to which a neck is attached.

[0004] In previous designs of this type of electrode, the connection element was a two-part design. The upper part (upper stud) serves as a contact and anchor element for standard signal conductors, such as ECG leads. Essentially below the electrode carrier, on the side facing the skin, is a lower stud (eyelet) that receives electrical potentials directly from the gel (contact medium) or transfers them to the gel. The eyelet is connected to the stud both electrically and mechanically, generally by riveting the two parts together, such that the electrode carrier material is firmly clamped between a flange-like, laterally projecting retaining area of ​​the stud and a similar retaining area of ​​the eyelet.Such a design offers, on the one hand, good mechanical retention of the connecting element on the electrode carrier and, on the other hand, allows the eyelet to be manufactured from materials that possess electrically favorable properties for a signal electrode. For example, it can be coated with silver, whereby the silver layer is then completely or at least partially covered by a layer of silver / silver chloride (Ag / AgCl) in the area that contacts the gel. It is also possible for the eyelet not to directly contact the gel. In these so-called off-center electrodes, a transverse conductor is provided to connect the eyelet to the gel.

[0005] However, state-of-the-art electrodes are expensive – although even slight price differences are significant for such mass-produced items.

[0006] The applicant's own patent specification AT 519280 A1 / WO 2018 / 071944 A2 therefore proposes that, instead of a commonly used two-part construction in which the connection element consists of two riveted parts (stud and eyelet), a single part should now be provided as the connection element, which on the one hand provides the connection point for the detachable connection of a signal conductor and on the other hand is connected to the electrical transverse conductor (preferably galvanically).

[0007] Patent specifications WO 01 / 17423 A2 and US 5,150,708 A also disclose electrodes with such one-piece formed connection elements.

[0008] However, such a one-piece design of the connecting element still has some disadvantages.

[0009] For example, an additional support layer is required to adequately secure the connection element to the carrier. This affects both the material requirements for an electrode and the manufacturing time of an electrode.

[0010] However, the material requirements and the manufacturing time of an electrode are decisive factors in its production costs. It is therefore desirable to keep the material requirements and the manufacturing time of an electrode as low as possible.

[0011] The object of the invention is therefore to provide an improved electrode compared to the electrode disclosed in patent specification AT 519280 A1 - particularly with regard to manufacturing costs and duration - as well as a method for manufacturing such an electrode.

[0012] According to the invention, this is achieved by an electrode according to claim 1 and a method according to claim 14.

[0013] It is therefore provided that the connecting element has at least one projection extending through the support, which at its end has an expanded area formed by deformation, whereby this deformed, expanded area enables, on the one hand, an electrical connection between the conductor and the connecting element and, on the other hand, a mechanical fastening of the connecting element to the support.

[0014] This can reduce both the material requirements and the manufacturing time of an electrode.

[0015] It is also advantageous that the connecting element is connected to the support and / or the conductor both positively and force-fit by means of the extended area formed by deformation.

[0016] Particularly preferred is the provision that the connection element consists of a single part which has the connection point for the detachable connection of a signal line.

[0017] The connecting element itself can consist of several materials, for example nickel-plated brass or a plastic doped with conductive material (especially carbon fibers).

[0018] A particularly preferred embodiment of the connecting element is one in which the connecting element is designed such that it has a substantially spherical head, a neck with a reduced diameter adjoining it, a flange-shaped holding area projecting laterally at the end of the neck, and at least one projection adjoining the holding area.

[0019] The projection is guided through an opening in the support (preferably without lateral contact), while the flange-shaped, laterally projecting retaining area rests on the top of the support. The flange-shaped, laterally projecting retaining area, with its increased diameter, securely holds the connecting element to the support material, even under high compressive loads.

[0020] The deformed, extended area of ​​the projection of the retaining element rests against the underside of the support or the conductor facing the skin, thus ensuring a good hold of the connecting element on the support even under pressure loads.

[0021] It can also be provided that the at least one projection consists of at least one first segment and at least one second segment, wherein both segments are in a horizontal or vertical position in an initial position, or wherein at least one of the at least two segments is in a horizontal position and at least one second of the at least two segments is in a vertical position, and that the holding area is formed by at least one of the at least two segments.

[0022] In this embodiment of the invention, the deformation of the deformable area can be achieved by simply bending at least one of the at least two segments.

[0023] According to a further embodiment of the invention, it can be provided that the laterally projecting flange-like holding area consists of at least two wing segments, wherein the at least two wing segments have a section inclined relative to a horizontal position, and that the projection is formed by the at least two wing segments, wherein preferably the at least two wing segments are formed with sharp edges at least in sections.

[0024] The at least two wing segments can be congruent or incongruent. In the latter case, the inclined sections in particular can be of different lengths.

[0025] In such an embodiment, it is possible to insert the connecting element into the support and conductor without first creating a through-hole through the support and the conductor – by combining a rotational and compressive movement of the connecting element on the top of the conductor. At least one of the at least two inclined sections can be reshaped by simply bending it towards the underside of the support.

[0026] If the wing segment sections have sharp edges, this facilitates penetration of a support and a conductor.

[0027] Another embodiment of the invention provides that the at least one projection is designed as a mandrel tapering in a direction opposite to the holding area. This makes it possible to insert the connecting element into the support or conductor without first creating a through-hole through the conductor and the support. This eliminates one work step.

[0028] The electrical properties of the connecting element are not subject to stringent requirements in the invention. It can therefore be made of inexpensive material, such as a simple sheet of metal. The connecting element itself does not need to possess any special electrical properties, because only the conductor in contact with the electrical contact medium can exhibit these properties, which are advantageous for bioelectrodes.

[0029] This conductor can, in principle, have any geometry; however, in preferred embodiments of the invention, the conductor can be designed as a rotationally symmetrical or substantially cuboid-shaped conductor disk. This conductor disk can project at least partially beyond the deformed, expanded area.

[0030] To achieve low noise and depolarization in defibrillation at an electrode, redox couples are currently used. These can be oxidized or reduced, thereby accepting or donating at least one electron. Currently, a wide variety of substances are used for this depolarization. Silver / silver chloride and tin / tin chloride are the most common. However, for the present invention, any redox couple that enables electrode depolarization is conceivable. The redox couples can be actively added or possibly generated in situ through reactions.Since, for example, silver / silver chloride is a relatively expensive substance, it is sufficient if, according to a further aspect of the invention, the conductor is provided on one side with an electrically conductive material which is galvanically connected to the connecting element and to the contact medium.

[0031] Further cost savings can be achieved by providing the conductor with an electrically conductive material on one side, as described in the invention. The actual conductor can use cost-effective materials such as metal or plastic, while a second, electrically conductive material, such as silver / silver chloride, can be used at the transition area to the electrical contact medium (especially gel), which is critical for the favorable electrical properties of the bioelectrode. It is sufficient for this material to be present only locally in this area.

[0032] In particular, the conductor can consist of a plastic film coated with an electrically conductive material.

[0033] Overall, the invention is based on the fundamental idea of ​​designing the connection 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 thus cost-effective materials can be used.

[0034] On the other hand, the more expensive materials intended for efficient electrical signal transmission can only be used in the electrically critical area at the interface with the electrical contact medium (gel). This task is performed by the conductor. In short, one could say that the electrically conductive connection element, apart from the fundamental property of electrical conductivity, is primarily responsible for the "mechanics." The conductor is the opposite: it does not need to fulfill any special mechanical requirements and only needs to be made of suitable materials in the area of ​​the interface with the electrical contact medium (gel). Therefore, the transverse conductor, without any special mechanical functions, is responsible for the "electrical" aspects.

[0035] Further advantages and details of the invention are explained in more detail with reference to the following description of figures. These show: Fig. 1 a schematic underside view (later the side facing the skin) of the manufacturing steps of an embodiment of an electrode according to the invention up to the finished electrode, Fig. 2 a schematic top view of the manufacturing steps of an embodiment of an electrode according to the invention up to the finished electrode, wherein only a part of the process steps are shown in a top view, Fig. 3 a sequence of sections along line AA of the Figure 1, wherein the representation is to be understood as a schematic representation for better visualization, Fig. 4 a schematic bottom view (later the side facing the skin) of the manufacturing steps of a further embodiment of an electrode according to the invention up to the finished electrode, Fig. 5 a schematic top view of the manufacturing steps of a further embodiment of an electrode according to the invention up to the finished electrode, wherein only a part of the process steps are shown in a top view, Fig. 6 a sequence of sections according to line AA of the Figure 4, wherein the representation is to be understood as a schematic representation for better visualization, Fig. 7 a schematic underside view (later the side facing the skin) of the manufacturing steps of a further embodiment of an electrode according to the invention up to the finished electrode, Fig. 8 a schematic top view of the manufacturing steps of a further embodiment of an electrode according to the invention up to the finished electrode, wherein only a part of the process steps are shown in a top view, Fig. 9 a sequence of sections according to line AA of the Figure 7, wherein the illustration is to be understood as a schematic representation for better visualization, Fig. 10 a schematic underside view of an embodiment of a carrier according to the invention with an adhesive layer, Fig. 11 a schematic underside view of a further embodiment of a carrier according to the invention with an adhesive layer, Fig. 12a a schematic side view of an embodiment of a connection element according to the invention, Fig. 12b a schematic top view of an embodiment of a connection element according to the invention, Fig. 13a a schematic side view of an anchoring process of a connection element according to the invention in a carrier, Fig. 13b a schematic top view (later the side facing away from the skin) of an anchoring process of a connection element according to the invention in a carrier, Fig. 14a a schematic view of a further embodiment of a connection element according to the invention, Fig.Fig. 14a schematic view of a further embodiment of a connection element according to the invention, Fig. 15a a schematic side view of a further embodiment of a connection element according to the invention, Fig. 15a schematic top view of a further embodiment of a connection element according to the invention, Fig. 16a a schematic side view of a further embodiment of a connection element according to the invention, Fig. 16a schematic top view of a further embodiment of a connection element according to the invention, Fig. 17a a schematic side view of a further embodiment of a connection element according to the invention, and Fig. 17a schematic top view of a further embodiment of a connection element according to the invention.Fig. 18 A schematic underside view (later the side facing the skin) of the manufacturing steps of a further embodiment of an electrode according to the invention, up to the finished electrode. Fig. 19 A schematic top view of the manufacturing steps. Fig. 20 A sequence according to the . Figures 18 and 19 in a sectional view. Figs. 21, 22 and 23 are similar views to those in the Figures 18, 19 and 20 , however, for a further embodiment.

[0036] With reference to the Figures 1 to 3 The process for manufacturing an embodiment of an electrode according to the invention for application to human skin will now be explained in more detail.

[0037] The starting point is an electrically non-conductive substrate 1. The substrate material serves to anchor the electrical components of the electrode. It can, for example, consist of a (flexible) film (e.g., made of PET or TPU) which is applied to the substrate shown in the drawing. Figure 1The underside facing upwards is completely or partially coated with an adhesive, which may be, for example, self-adhesive (pressure sensitive adhesive) or thermo-activated (hot melt).

[0038] In a next step, a rotationally symmetrical conductor 3 is attached to this carrier material, in particular by gluing or printing. According to a preferred embodiment of the invention, the conductor comprises two differently electrically conductive materials or an electrically 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 galvanically connected to the electrical connection element 2 and to the contact medium 4 (gel).

[0039] The illustrated embodiment is a circular conductor 3, shown in black or gray, made of a plastic film. However, the conductor 3 can also be made of a metal or a conductive plastic doped with carbon fibers.

[0040] In the area of ​​the later contact point with the electrical contact medium 4 (gel), this conductor 3 is coated with a layer 3a of, for example, silver / silver chloride or tin / tin chloride or another redox couple.

[0041] In a further step, an opening 8 is provided through the electrical conductor 3 and the support 1. This can be done, for example, by punching. The connecting element 2, which has a projection 2b extending beyond the underside of the support 1 and the conductor 3, is then inserted.

[0042] In the illustrated embodiment, the connecting element 2 has a neck 2d with a reduced diameter following the essentially spherical head 2c, to which a flange-shaped, laterally projecting retaining area 2e and a projection 2b are attached.

[0043] Overall, the laterally projecting, flange-shaped retaining area 2e is essentially plate-shaped. It serves to distribute and transfer compressive forces applied to the connecting element 2 to the support 1.

[0044] If a connection element 2 is used, consisting of a single part that is connected to the electrical conductor 3 on one side and has the connection point 2a for the detachable connection of a signal conductor (not shown here) on the other, cost-effective manufacturing of the electrode is possible because the usually expensive eyelet (bottom knob) can be omitted. The one-piece design of the connection element is sufficient for mechanical anchoring.

[0045] The requirements for the electrical properties are low. This allows for the use of simple designs, such as a deep-drawn metal part as the connection element 2. The somewhat more complex electrical tasks are therefore not performed by the usual eyelet (bottom button) but by the conductor 3, which is in contact with the subsequently applied electrical contact medium 4 (gel).

[0046] Thus, the tasks are separated. Apart from its basic property of being electrically conductive, the electrical connection element 2 is essentially responsible for the mechanical hold in the electrode, while conductor 3 is largely relieved of mechanical functions. This allows for a more favorable choice of material. In particular, it is possible to use more expensive – and electrically advantageous – materials only where (point 3a) contact with the gel later occurs.

[0047] The electrically conductive connection element 2 can – as already mentioned – consist of a deep-drawn metal sheet. In this case, it is at least partially hollow inside. However, it can also consist of a conductive plastic, for example ABS doped with conductive carbon fibers.

[0048] Ideally, the connecting element should be designed to be essentially rotationally symmetrical. Other variations are also possible.

[0049] In order to finally fix the electrical connection element 2 in the electrode and in particular to secure it against tensile loads, in a next step the projection 2b is deformed in such a way that a deformed, extended area BZ is produced.

[0050] The deformation of the projection 2b can be achieved by melting, crimping, spreading, or bending. However, any other suitable method is also applicable.

[0051] By deforming the projection 2b, a galvanic connection is established between the connecting element 2 and the conductive material 3a of the conductor 3 via the deformed, extended area BZ, and on the other hand, a mechanical fastening of the connecting element 2 to the carrier 1 is established by means of form and / or force locking.

[0052] A layer of adhesive tape 7 is now applied to the underside of the carrier 1, in particular by gluing, wherein the adhesive tape layer is preferably able to be adhered to the skin by means of a patient-side coating of biocompatible adhesive in order to fix the electrode.

[0053] It is also possible to bond the plaster layer to the carrier 1 via a layer of self-adhesive or a thermo-activated adhesive applied to it.

[0054] The adhesive material ultimately serves to fix the electrode to the patient's skin. Suitable adhesive materials can consist of, for example, a film (e.g., PE), a foam strip (e.g., PE foam), or non-woven fabrics. The adhesive materials are usually coated on the patient side with a biocompatible adhesive.

[0055] In a final manufacturing step of the electrode according to the Figures 1 to 3The electrical contact medium 4 is introduced into a designated recess in the patch material 7. The electrical contact medium 4 enables the (preferably ion-based) conduction of body-generated electrical potentials or device-generated measurement or stimulation currents from the body surface (skin) to the electrical connection element 2 and vice versa. The contact medium 4 can, for example, consist of a chloride-doped gel, which is either in a more or less liquid form (more or less gelled) or as a cross-linked polymer matrix (hydrogel). However, it is also possible to produce the electrical contact medium 4 using other means, such as a conductive adhesive or a sponge filled with saline solution.

[0056] In any case, the electrical contact medium 4, as described in the last step in the Figures 1 to 3The figure shows that it is inserted into the recess in the paving material 7. It makes contact with the electrically conductive material 3a (especially silver / silver chloride) within it.

[0057] The interaction of the electrically conductive material 3a, in particular the coating with silver / silver chloride or another suitable material, on the one hand, and the material of the electrically conductive contact medium 4, on the other hand, makes it possible to achieve favorable electrical properties of the electrode, such as noise-free signal transmission or depolarizing effects, whereby the use of the relatively expensive electrically conductive material 3a of the conductor 3 can be limited to the area where contact with the contact medium 4 occurs. This further reduces costs.

[0058] Overall, the manufacturing process according to the Figures 1 to 3 a "central" electrode in which the connection element 2 and the contact medium 4 (gel) are arranged directly on top of each other.

[0059] The embodiment according to the Figures 1 to 3 The essential procedural steps are as follows: Arranging, preferably by gluing or printing, a conductor (3) on the underside of an electrically non-conductive carrier (1) facing the skin, inserting a connection element (2) from the top of the carrier through it, such that the projection (2b) of the connection element (2) protrudes on the opposite underside of the carrier (1) and the connection element (2) – preferably with a laterally projecting, plate-shaped retaining area (2e) – rests against the top of the carrier (1), deforming the projection (2b) of the connection element (2) such that a deformed, expanded area (BZ) is produced which on the one hand creates an electrically conductive connection between the connection element (2) and the conductor (3) and on the other hand provides a mechanical fastening of the connection element (2) to the carrier (1).

[0060] Finally, the following steps are taken to complete the electrode: Attaching - preferably bonding - a skin-side adhesive patch layer 7 to the carrier 1, introducing an electrical contact medium 4 - preferably a gel - into a recess of the patch layer 7, such that the underlying conductor 3 is contacted.

[0061] In the Figures 4 to 6 In the illustrated embodiment, most of the process steps correspond to those in Figures 1 to 3 They are identical, which is why the same reference symbols denote the same parts.

[0062] The main difference is that a "decentralized" electrode is used. This means that the contact medium 4 and the connection element 2 are offset from each other in a horizontal plane H.

[0063] In such an embodiment, it is necessary to provide an electrically conductive transverse conductor 10, which establishes a galvanic connection between the conductor 3 and the connecting element 2.

[0064] During the deformation of the projection 2b, pressure can be exerted on the layers, causing them to contour accordingly and bond together. The in Figure 6 The cross-section shown after the application of paving layer 7, with the edges shown there, is merely a schematic representation. In reality, the layer thicknesses are usually less and the course of the layers is much more rounded.

[0065] It is further evident that the deformed, enlarged area BZ is no longer circular, but lamellar in shape. In principle, however, the deformed, enlarged area BZ can have any shape.

[0066] In the Figures 7 to 9In the illustrated embodiment, most of the process steps correspond to those in Figures 1 to 3 They are identical, which is why the same reference symbols denote the same parts.

[0067] The main difference is that the carrier 1 has a biocompatible adhesive layer 11 for attaching the electrode to a patient's skin. This eliminates the need for the adhesive layer 7 and saves a further process step.

[0068] The adhesive layer 11 can be applied before or after the conductor 3 is applied to the carrier 1, or the adhesive layer 11 may already be present on the base material of the carrier 1.

[0069] In the Figures 10 and 11 The above-mentioned variants for applying the adhesive 11 are shown.

[0070] In Figure 10The adhesive 11 is already present on the carrier 1 or is applied before the conductor 3 is applied. The conductor 3 is then applied to the adhesive layer 11. The adhesive layer 11 holds the conductor 3 in place, eliminating the need for additional bonding of the conductor 3 to the carrier 1.

[0071] In Figure 11 The conductor 3 is applied to the carrier 1, and then the adhesive 11 is applied to the carrier 1. A recess 11a is provided so that the conductor 3 is not covered by the adhesive 11.

[0072] The Figures 12a and 12bFigure 1 shows an embodiment of a connecting element 2 according to the invention. It can be seen that the connecting element 2 has wing segments 9, which form both the projection and the holding area of ​​the connecting element 2. The wing segment sections 9a, which are inclined relative to a horizontal position H, can be of the same or different lengths. It is also conceivable that the wing segments 9 are at least partially sharp-edged to facilitate penetration of a support 1 and a conductor 3.

[0073] The Figures 13a and 13b The schematic views show an anchoring process of a connection element according to the invention in a support, with a [missing information] as in the Figures 12a and 12b shown connection element 2.

[0074] In a first step, the connecting element 2 is pressed from the upper side of a support 1 (which will later face away from the skin) through the support 1 and the conductor 3 (not shown) attached to the underside of the support 1. That is, the connecting element 2 penetrates the support 1 and the conductor 3 with the wing segment sections 9a.

[0075] In the next step, the connecting element 2 is rotated in direction D. This results in better anchoring of the connecting element 2 in the support 1.

[0076] In a final step, the wing segment sections 9a are bent upwards towards the underside of the support 1 beyond a horizontal position H, thereby clamping the support 1 and the conductor 3. This ensures both an electrical connection between the connecting element 2 and the conductor 3, as well as a mechanical fastening of the connecting element 2 to the support 1. However, it is also possible to bend the wing segment sections upwards only until they reach a horizontal position H.

[0077] The Figure 14a Figure 1 shows an embodiment of a connecting element 2 in which the projection 2b is designed as a tapered mandrel. This makes it possible to insert the connecting element 2 into the support 1 or the conductor 3 without first creating a through opening 8 through the conductor 3 and the support 1. This eliminates one work step.

[0078] Figure 14bFigure 1 shows an embodiment of a connecting element 2 in which two projections 2b are designed as tapered mandrels. However, any number of projections 2b can be provided. Furthermore, several projections 2b that are not mandrel-shaped can also be provided. The majority of projections 2b can be arranged rotationally symmetrically or non-rotationally symmetrically on the connecting element 2.

[0079] The Figures 15a to 17b Figure 1 shows exemplary embodiments of a connecting element 2 in which the projection and the flange-like holding area of ​​the connecting element 2 are formed from at least a first segment 5 and at least a second segment 6.

[0080] It is also evident that the second segments 6 are longer than the first segments 5. Segments 5 and 6 can also be of the same length, or segments 5 can be longer than segments 6.

[0081] Figure 15a The connecting element is shown in a frontal view when all segments 5, 6 are in a horizontal position H. Figure 15b shows the corresponding top view.

[0082] Figure 16a The diagram shows the connection element in a frontal view when segments 5 are in a horizontal position H and segments 6 are in a vertical position V. Figure 16b shows the corresponding top view.

[0083] Figure 17a The connecting element is shown in a frontal view when all segments 5, 6 are in a vertical position H. Figure 17b shows the corresponding top view.

[0084] In the case of a connection element 2 according to the Figures 15a and 15bBefore the connection element 2 is inserted into the support 1, at least one first segment 5 of the at least two segments 5,6 is transferred into a vertical position V and after the connection element 2 is inserted into the support 1, at least one first segment 5 is transferred back into a horizontal position H.

[0085] In an embodiment of a connecting element 2 according to the Figures 17a and 17b Before the connection element 2 is inserted into the support 1, at least a first segment 5 is transferred into a horizontal position H, and after the connection element 2 is inserted into the support 1, at least a second segment 6 is transferred into a horizontal position H.

[0086] In the previous embodiments according to the Figures 1 to 17b The conductor 3 and the contact medium 4 were formed from separate components and also consist preferably of different materials.

[0087] However, it is also possible that the conductor 3 and the contact medium 4 are formed by one and the same component, preferably an electrically conductive adhesive, which allows for a reduction in the number of components overall. This will be shown below using the following examples. Figures 18 to 23 explained in more detail.

[0088] In the Figures 18 and 20 In the illustrated embodiment, an opening 18 is first made in a carrier. A connecting element is inserted into this opening, and the protruding area is then enlarged by deformation. The enlarged area BZ then securely holds the connecting element 2 to the carrier. Subsequently, a layer of electrically conductive adhesive 12 is applied, which allows the finished electrode to be adhered to the patient's skin. The electrically conductive layer of adhesive 12 therefore assumes the function of the conductor 3 and the contact medium 4.

[0089] During the Figures 18 and 20In the illustrated embodiment, the adhesive 12 is applied over the entire surface of the underside of the carrier 1.

[0090] In the Figures 21 to 23 In the illustrated embodiment, most of the manufacturing steps are identical to those in the example according to the Figures 18 to 20 Only in the penultimate step is the electrically conductive adhesive 12, which takes on the function of the conductor 3 and the contact medium 4, not applied over the entire surface, but only partially – as the Figure 21 shown, in the form of a stripe - applied.

[0091] In a final step, an adhesive patch material 7 with a central opening is applied, through which the electrically conductive adhesive remains exposed as a contact medium. Thus, adhesion to the skin occurs via the adhesive patch material 7 on the one hand and the electrically conductive adhesive 12 on the other. The advantage of the variant according to the Figures 21 to 23This results in excellent adhesion thanks to the adhesive plaster material 7 and a saving in electrically conductive adhesive compared to the full-surface variant according to the Figures 18 to 20 . For the latter figures, an additional building element, namely the paving material 7, can be omitted.

[0092] In the embodiments of the invention, in particular a second layer of the conductor - as described above - can be formed by a layer of silver / silver chloride or tin / tin chloride or another redox couple.

[0093] However, it is also possible that other electrically conductive components are equipped with such redox couples, in particular the contact medium 4 and / or the connection element 2. To conserve the relatively expensive redox components, not all conductive elements will be equipped with such redox couples simultaneously, although this is theoretically possible. As already mentioned, it is sufficient if a second layer of the conductor 3 is equipped with such a redox couple. In principle, it is also possible to omit the redox couples altogether and provide that neither the connection element 2, nor the conductor 3, nor the contact medium 4 contains such a redox couple. Reference symbol list:

[0094] 1. Carrier 2. Connection element 2a. Connection point 2b. Projection 2c. Head 2d. Neck 2e. Holding area 3. Conductor 3a. Electrically conductive material 3b. Electrically non-conductive material 4. Contact medium 5. First segment 6. Second segment 7. Patch layer 8. Opening 9. Wing segment 9a. Wing segment section 10. Transverse conductor 11. Adhesive layer (skin adhesive) 11a. Recess 12. Electrically conductive adhesive H Horizontal V Vertical BZ Deformed, extended area

Claims

1. An electrode for application to the human skin having an electrically non-conducting carrier (1) which on its top side that faces away from the skin has a projecting electrically conducting connecting element (2) having a connecting location (2a) for releasable connection of a signal conductor, wherein there is provided a conductor (3) which is arranged at least partially on the opposite underside of the carrier (1) and which is electrically connected to the connecting element (2) and to a contact medium (4) that faces towards the skin, wherein the connecting element (2) has at least one projection (2b) which passes through the carrier (1) and which at its end has an enlarged region (BZ) formed by deformation, wherein on the one hand an electrical connection between the conductor (3) and the connecting element (2a) and on the other hand mechanical fixing of the connecting element (2) to the carrier (1) can be made by that deformed enlarged region (BZ), wherein the connecting element (2) has a substantially ball-shaped head (2c), a neck (2d) of reduced diameter adjoining the same and a holding region (2e) which adjoins the end of the neck (2d) and which projects laterally in a flange shape and wherein the at least one projection (2b) adjoins the holding region (2e), wherein the conductor (3) is coated with an electrically conducting material on one side, and wherein the electrically conducting material is formed by a pair silver / silver chloride or tin / tin chloride or another redox couple suitable for example for depolarization of the electrode or comprises such redox couples, and wherein the connecting element (2) is connected on the underside and the top side of the carrier (1) to the same with interposition of a flat conductor.

2. Electrode according to claim 1, characterized in that the connecting element (2) comprises a single part which has the connecting location (2a) for releasable connection of a signal line.

3. Electrode according to one of claims 1 or 2, characterized in that the at least one projection (2b) is formed from at least one first segment (5) and at least one second segment (6), wherein the at least two segments (5, 6) in a starting position are preferably in a horizontal position (H) or in a vertical position (V), or wherein at least one of the at least two segments (5, 6) is in a horizontal position (H) and at least a second of the at least two segments (5, 6) is in a vertical position (V) and that the flange-like holding region (2e) is formed by at least one of the at least two segments (5, 6).

4. Electrode according to one of claims 1 to 3, characterized in that the at least one projection (2b) is in the form of a spike narrowing in the direction opposite to the holding region (2e).

5. Electrode according to one of claims 1 to 4, characterized in that the connecting element (2) has at least two wing segments (9), wherein the at least two wing segments (9) have a portion (9a) inclined with respect to a horizontal position (H), wherein the wing segments form the projection (2b) and the laterally projecting flange-like holding region (2e), wherein preferably the at least two wing segments (9) are at least portion-wise of a sharp-edged configuration.

6. Electrode according to one of claims 1 to 5, characterized in that the conductor (3) is in the form of a conducting plate projecting at least partially beyond the deformed enlarged region (BZ).

7. Electrode according to one of claims 1 to 6, characterized in that the connecting element (2) on the one hand and the contact medium (4) on the other hand are arranged at laterally mutually displaced positions on the carrier (1).

8. Electrode according to one of claims 1 to 7, characterized in that the carrier (1) is coated on the side towards the skin with adhesive, preferably a skin adhesive, which is preferably a pressure sensitive adhesive or is thermo-activatable, or has a plaster layer (7) provided with an adhesive, preferably a skin adhesive.

9. Electrode according to one of claims 1 to 8, characterized in that the conductor (3) and the contact medium (4) are formed by separate components and preferably comprise different materials (Figures 1 through 17b), or that the conductor (3) and the contact medium (4) are formed by one and the same component - preferably by an electrically conductive adhesive with which the electrode can be glued to the surface of a patient (Figures 18 through 23).

10. Electrode according to one of claims 1 to 9, characterized in that the connecting element (2) and / or the contact medium (4) is at least portion-wise formed by a pair silver / silver chloride, tin / tin chloride or another redox couple suitable for example for depolarization of an electrode or such redox couples or comprises such redox couples.

11. Method for producing an electrode for application to the human skin according to one of claims 1 to 10, characterized by: - arranging, preferably gluing or printing, a conductor (3) on the underside, towards the skin, of an electrically non-conducting carrier (1), wherein the conductor (3) is coated with an electrically conducting material on one side, and wherein the electrically conducting material is formed by a pair silver / silver chloride or tin / tin chloride or another redox couple suitable for example for depolarization of the electrode or comprises such redox couples, - introducing a connecting element (2) from the top side of the carrier (1) through the same in such a way that the projection (2b) of the connecting element (2) projects on the opposite underside of the carrier (1) and the connecting element (2) bears against the top side of the carrier (1) - preferably with a laterally projecting plate-shaped holding region (2e), wherein the connecting element (2) is connected on the underside and the top side of the carrier (1) to the same with interposition of a flat conductor, - deforming the projection (2b) of the connecting element (2) in such a way that there is produced a deformed enlarged region (BZ) which on the one hand makes an electrically conductive connection between the connecting element (2) and the conductor (3) and on the other hand provides for mechanical fixing of the connecting element (2) to the carrier (1).

12. Method according to claim 11, characterized in that deformation of the projection (2b) is effected by: - fusing the projection (2b), and / or - beading over the projection (2b), and / or - spreading open the projection (2b), and / or - bending over the projection (2b).

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