Electrode for attachment to the human skin

Abstract

The invention relates to an electrode (1) for attachment to the human skin, comprising an electrically nonconductive carrier (2) and an electrically conductive connection element (3) for connecting a signal conductor (4), with provision being made for a conductor (5) which is at least partially arranged on the lower side (2a) of the carrier (2) intended to be skin side and which is electrically connected to the connection element (3) and to a contact medium (6) intended to be skin side, wherein the connection element (3) is joined to the signal conductor (4) and / or the conductor (5) by heat staking.

Description

[0001] Electrode for application to human skin

[0002] The invention relates to an electrode for application to human skin, comprising an electrically non-conductive carrier, an electrically conductive connection element for connecting a signal conductor, wherein a conductor is provided which is arranged at least partially on the underside of the carrier facing the skin and which is electrically connected to the connection element and to a contact medium facing the skin, and to a method for producing an electrode for application to human skin.

[0003] Such electrodes are already known from the prior art. The conductor is usually a metal foil. The signal conductor is then riveted to the conductor and the carrier, thus establishing both an electrical and a mechanical connection between the conductor / carrier and the signal conductor. The disadvantage is that riveting the signal conductor to the conductor / carrier is relatively complex.

[0004] When performing examinations using various X-ray techniques, it is often desirable to collect additional data or monitor certain patient parameters using measuring electrodes. However, the electrodes described above are not suitable for this purpose, as the metallic components of the electrodes create shadows on the X-ray image, which can render the X-ray image unsuitable for further analysis.

[0005] To avoid this, it is known to manufacture a conductor from X-ray transparent material, for example carbon fiber or conductive plastic, in order to minimize the influence of the electrodes on an X-ray image. However, metallic conductors and connection elements are still often used, which in turn are visible on an X-ray image. If an X-ray transparent signal conductor is also provided, this is usually glued to the conductor. For this purpose, the wires of the signal conductor are fanned out and bonded to the conductor using adhesive and / or adhesive tape. Fanning out serves to create the best possible electrically conductive connection between the signal conductor and conductor. This type of connection is complex and has relatively low mechanical strength.

[0006] The object of the invention is to at least partially eliminate the disadvantages described above and to provide an electrode which is improved compared to the prior art and a method for producing an electrode.

[0007] This object is achieved by the features of independent claims 1 and 18 .

[0008] According to the invention, it is therefore provided that the connecting element is hot-stitched to the signal conductor and / or the conductor.

[0009] Hot-staking provides a simple and uncomplicated way to electrically and mechanically connect the signal conductor to the connection element and / or the conductor to the connection element, and thus the signal conductor via the connection element to the conductor. Hot-staking creates a positive and force-locking connection, thus ensuring sufficient mechanical strength.

[0010] With regard to a method according to the invention, the following

[0011] Process steps provided: Arranging, preferably gluing or printing, a conductor on the underside of an electrically non-conductive carrier facing the skin,

[0012] Inserting a connecting element into the carrier, wherein the connecting element - preferably with a flange-like holding area - rests on the underside of the conductor facing the skin and / or the upper side of the carrier facing away from the skin,

[0013] Inserting a signal line into a receiving area of ​​the connection element and hot-staking the receiving area.

[0014] Compared to gluing or riveting the signal conductor to the conductor / carrier, hot-staking is significantly simpler and faster. This allows an electrode to be manufactured in a shorter time, which in turn brings economic advantages.

[0015] Further advantageous embodiments of the invention are defined in the dependent claims.

[0016] Particularly preferably, the electrode can be designed to be at least partially X-ray transparent. This makes it possible to use the electrode during measurements during

[0017] to use X-ray examinations.

[0018] Preferably, it can be provided that the connecting element is made of a conductive plastic and / or carbon fiber.

[0019] It can further be provided that the conductor is made of a conductive plastic and / or carbon fiber. Finally, it can be provided that the signal conductor is made at least partially of a conductive plastic and / or carbon fiber.

[0020] This represents a simple way to make the conductive components of the electrode X-ray transparent. It is particularly advantageous if the connecting element, the conductor, and the signal conductor are made of a conductive plastic and / or carbon fiber, as the electrode is thus completely X-ray transparent.

[0021] It can also be provided that the conductor is coated on its side facing the contact medium with a pair of silver / silver chloride, tin / tin chloride or another redox pair suitable, for example, for depolarizing the electrode.

[0022] These redox pairs serve to achieve low noise and depolarization in an electrode during defibrillation. They can be oxidized or reduced, thereby gaining or losing at least one electron. Silver / silver chloride, tin / tin chloride, and tin-antimony are the most commonly used. However, any redox pairs that enable depolarization of the electrode are conceivable for the present invention. The redox pairs can be actively added or possibly generated in situ through reactions.

[0023] It can be provided that the signal conductor has at least one wire and insulation.

[0024] It can further be provided that at least one wire and / or the insulation is hot-stitched to the connecting element. An electrical and mechanical connection between the signal conductor and the connecting element can be achieved via the wire. If the insulation is also hot-stitched to the connecting element, a more stable mechanical connection can be achieved.

[0025] According to one embodiment, the at least one wire and the insulation can be hot-stitched to the connecting element separately from one another.

[0026] This allows the insulation to act as strain relief for the signal conductor.

[0027] In principle, it is also conceivable that the connecting element or a part of the connecting element is an integral part of the signal conductor. For example, the connecting element or a part of it can be injection-molded onto the signal conductor during production.

[0028] It can be provided that the connecting element is formed in one piece.

[0029] This represents the simplest and most cost-effective design for a connecting element. However, a multi-part design of the connecting element is also conceivable.

[0030] Advantageously, it can be provided that the connecting element has at least one flange-like holding area for contact with the underside of the conductor facing the skin and / or the upper side of the carrier facing away from the skin.

[0031] This facilitates the manufacture of an electrode, as the connecting element can be secured to the electrode via the holding area. Furthermore, the holding area provides the electrode with increased stability in the area where it connects to the signal conductor.

[0032] Preferably, it can be provided that the connection element has at least one receiving area for at least partially receiving the signal line.

[0033] The receiving area can be formed by a simple opening or by slots. In principle, however, a wide variety of receiving area designs are conceivable.

[0034] It can also be provided that the connecting element has a connecting region for connecting the connecting element to the conductor and / or carrier.

[0035] The connection area can also take on a variety of shapes. A simple option would be a pin, which is then hot-stitched.

[0036] If the carrier and / or the conductor has an opening for the insertion of the connecting element, the connecting element can be easily and safely connected to the carrier and / or conductor.

[0037] Furthermore, it can be provided that the connecting element is connected to the carrier by interposing the conductor on the underside and the top side of the carrier.

[0038] This ensures the best possible mechanical connection between the connecting element and the carrier.

[0039] Preferably, it can be provided that the carrier is coated on the underside facing the skin with adhesive, preferably a skin adhesive, which is preferably self-adhesive or thermo-activated, or has a plaster layer provided with an adhesive, preferably a skin adhesive.

[0040] This provides a simple way to position the electrode on a patient.

[0041] Particularly preferably, it can be provided that the adhesive is electrically conductive and the contact medium is formed by the adhesive.

[0042] This simplifies the design and manufacture of the electrode.

[0043] With regard to a method, it can be provided that before the introduction of a connecting element, a through opening is produced through the carrier and the conductor, preferably by punching.

[0044] The connecting element can then be inserted into the opening.

[0045] It can also be provided that a connection area - and thus the connecting element with the carrier - is hot-stitched.

[0046] This provides a simple way to connect the connecting element to the carrier.

[0047] The following additional steps may also be required:

[0048] Coating the underside of the carrier facing the skin with adhesive, or

[0049] Applying a with an adhesive, preferably a

[0050] Skin adhesive, provided plaster layer, and introduction of a contact medium - preferably a gel - into a recess of the plaster layer in such a way that the underlying conductor is contacted.

[0051] Further details and advantages of the invention are explained in more detail below with reference to the figures and the drawings.

[0052] Fig. l is a schematic bottom view (later the side facing the skin) of the manufacturing steps of an embodiment of an electrode,

[0053] Fig. 2 is a schematic plan view of the manufacturing steps of an embodiment of an electrode, with only a part of the process steps being shown in a plan view,

[0054] Fig. 3 is a schematic representation of the sequence of cuts along the line AA of Figure 1,

[0055] Fig. 4 is a schematic bottom view (later the side facing the skin) of the manufacturing steps of a further embodiment of an electrode,

[0056] Fig. 5 is a schematic plan view of the manufacturing steps of a further embodiment of an electrode, wherein only a part of the process steps is shown in a plan view,

[0057] Fig. 6 is a schematic representation of the sequence of cuts along the line AA of Figure 4, and

[0058] Fig . 7 a-7 e schematic representations of various

[0059] Embodiments of a connecting element.

[0060] With reference to Figures 1 to 3, the process sequence for producing an exemplary embodiment of an electrode 1 according to the invention for application to human skin will be explained in more detail below. The starting point is an electrically non-conductive carrier 2. The carrier material serves to anchor the electrical components of the electrode 1. It can, for example, consist of a (flexible) film (e.g., made of PET or TPU).

[0061] In the next step, a conductor 5 is applied to this carrier material, which in this exemplary embodiment completely covers the carrier 2. It is also conceivable that the conductor 5 is applied only at specific locations on the carrier 2. In particular, the conductor 5 is glued or printed.

[0062] In this embodiment, conductor 5 is made of carbon fiber or conductive plastic. If X-ray transparency is not desired, conductor 5 could also be made of metal.

[0063] In this embodiment, the conductor 5 is coated with a layer 5a of, for example, silver / silver chloride, tin / tin chloride, tin-antimony or another redox couple.

[0064] In a further step, an opening 7 is provided through the electrical conductor 5 and the carrier 2. This can be done, for example, by punching. The connecting element 3 is then inserted.

[0065] In the illustrated embodiment, the connecting element 3 has a cylindrical section, to which a flange-shaped, laterally projecting holding region 3a is connected. In this embodiment, both the receiving region 3b and the connecting region 3c are formed on or by the cylindrical section. Overall, the laterally projecting flange-shaped holding region 3a is essentially plate-shaped. If a connecting element 3 is used which consists of a single part, this enables cost-effective production of the electrode. The one-piece design of the connecting element 3 is sufficient for mechanical anchoring.

[0066] In the next step, a coating of biocompatible adhesive is applied to the underside 2a of the carrier 2, by means of which the electrode 1 can be fixed to the skin of a patient.

[0067] In this embodiment, the biocompatible adhesive is electrically conductive and thus acts as a contact medium 6. The electrical contact medium 6 enables the (preferably ion-based) conduction of body-generated electrical potentials or device-generated measuring or stimulation currents from the body surface (skin) to the electrical connection element 3 and vice versa.

[0068] Alternatively, it is also conceivable to apply a plaster layer, which serves to fix the electrode 1 to the patient's skin. The contact medium 6 can then consist, for example, of a chloride-doped gel, which is present either in a more or less liquid form (more or less gelled) or as a cross-linked polymer matrix (hydrogel).

[0069] Suitable plaster materials can consist of, for example, a film (e.g., PE), a foam strip (e.g., PE foam), or nonwovens. The plaster materials are usually coated with a biocompatible adhesive on the patient side.

[0070] Additionally, a rivet insulation 6a is applied, which insulates the area in which the connecting element 3 is arranged from the patient's skin. This prevents excessive stress on the patient's skin below the connecting element 3.

[0071] In a further manufacturing step of the electrode according to Figures 1 to 3, a cover 8 is applied which protects the contact medium 6 until the electrode 1 is used.

[0072] In a next step, a signal conductor 4, in this exemplary embodiment only the wires 4a, is inserted into a receiving area 3b of the connecting element 3. For this purpose, the receiving area has an opening into which the signal conductor 4 can be inserted.

[0073] In order to finally fix the electrical connection element 3 in the electrode 1 and to establish an electrically conductive connection between the signal conductor 4 and the conductor 5, in a next step the signal conductor 4 is hot-stitched in the receiving area 3b to the connection element 3 and the carrier 2 and the conductor 5 are hot-stitched in the connection area 3c to the connection element 3.

[0074] Hot staking can be carried out in the traditional way using a heated stamp or contactless using laser or infrared radiation.

[0075] Since the receiving area 3b and the connecting area 3c are combined in this exemplary embodiment, hot-staking only needs to be performed once. This allows an electrode 1 to be manufactured quickly and easily. The hot-staking process creates a rivet head, which in turn functions as the holding area 3a.

[0076] In the embodiment shown in Figures 4 to 6, most of the process steps correspond to those in Figures 1 to 3, which is why the same reference symbols designate the same parts.

[0077] The difference essentially consists in the fact that a different embodiment of a connecting element 3 is used.

[0078] It can be seen that the connecting element 3 is now formed in two parts. A lower part is similar to the connecting element 3 according to Figures 1 to 3 and has a holding area 3a and a cylindrical section. The upper part also has a holding area 3a, wherein the upper holding area 3a has an opening for receiving the cylindrical section. The cylindrical section, together with the corresponding opening, forms the connecting area 3c.

[0079] At the top, a section resembling a wire end ferrule can also be seen. This section forms the receiving area 3b.

[0080] In this embodiment, multiple hot-staking steps are necessary. The connecting region 3c with the carrier 2 and the conductor 5 is hot-stacked once to create a mechanical connection between the connecting element and the carrier, as well as an electrical connection between the connecting element 3 and the conductor 5.

[0081] Furthermore, the receiving area 3b of the connecting element 3 is hot-stitched to the signal conductor 4. In this process, the wires 4a and the insulation 4b are hot-stitched separately to the connecting element 3. By separately connecting the wires 4a and the insulation 4b, strain relief of the signal conductor 4 can be achieved.

[0082] Figures 7a to 7e show schematic representations of various embodiments of a connection element 3. The embodiment according to Figure 7a is similar to the connection element 3 shown in Figures 1 to 3. In contrast, however, the connection element 3 according to Figure 7a also has an extension in extension of the opening for receiving the signal conductor 4. This extension serves to receive the insulation 4b of the signal conductor 4, whereby additional mechanical stability can be achieved in the connection between the signal conductor 4 and the connection element 3.

[0083] The embodiment according to Figure 7b has slots for receiving the signal conductor 4, into which the wires 4a of the signal conductor 4 can be inserted. In this embodiment, too, the receiving area 3b and the connecting area 3c are combined.

[0084] The embodiment according to Figure 7c corresponds to the embodiment shown in Figures 4 to 6. The embodiment according to Figure 7d is very similar to that of Figure 7c, but has a snap connector in the connection area 3b for connecting the connection element 3 to the carrier 2 and conductor 5. In this embodiment, therefore, only the signal conductor 4 is hot-stitched to the connection element 3.

[0085] The connecting element 3 according to Figure 7e is a further modification of the embodiments according to Figures 7c and 7d. In this case, the connecting element 3 is again designed in one piece and has only one holding area 3a. A cylindrical section adjoins the holding area 3a in a downward direction. The connecting element according to Figure 7e is not inserted into the carrier 2 from the underside 2a, but from the top side 2b. The connecting element 3 can be connected to the carrier 2 and the conductor 5 by hot-staking the cylindrical section. By forming a rivet head during hot-staking, a holding area 3a is formed on the underside 2a of the carrier 2, which also establishes the electrical contact with the conductor.

[0086] The exemplary embodiments shown in Figures 7a to 7e merely illustrate various possible configurations for connecting element 3. Naturally, numerous other configurations of connecting elements are also conceivable within the scope of this invention.

[0087] Reference symbol list:

[0088] 1 electrode

[0089] 2 carriers

[0090] 2a bottom

[0091] 2b Top

[0092] 3 connecting element

[0093] 3a Holding area

[0094] 3b Recording area

[0095] 3c Connection area

[0096] 4 signal conductors

[0097] 4a wire

[0098] 4b I insulation

[0099] 5 ladders

[0100] 5a Coating redox couple

[0101] 6 Contact medium

[0102] 6a Rivet insulation

[0103] 7 Opening

[0104] 8 Cover

Claims

Patent claims:

1. Electrode (1) for application to human skin, comprising an electrically non-conductive carrier (2), an electrically conductive connection element (3) for connecting a signal conductor (4), wherein a conductor (5) is provided which is arranged at least partially on the underside (2a) of the carrier (2) facing the skin and is electrically connected to the connection element (3) and to a contact medium (6) facing the skin, characterized in that the connection element (3) is hot-stitched to the signal conductor (4) and / or the conductor (5).

2. Electrode according to claim 1, wherein the electrode (1) is at least partially X-ray transparent.

3. Electrode according to one of claims 1 or 2, wherein the connecting element (3) is made of a conductive plastic and / or carbon fiber.

4. Electrode according to one of claims 1 to 3, wherein the conductor (5) is made of a conductive plastic and / or carbon fiber.

5. Electrode according to one of claims 1 to 4, wherein the signal conductor (4) is made at least partially of a conductive plastic and / or of carbon fiber.

6. Electrode according to one of claims 1 to 5, wherein the conductor (5) is coated on its side facing the contact medium (6) with a pair of silver / silver chloride, tin / tin chloride or another redox pair suitable, for example, for depolarizing the electrode (1).

7. Electrode according to one of claims 1 to 6, wherein the signal conductor (4) has at least one wire (4a) and an insulation (4b).

8. Electrode according to claim 7, wherein the at least one wire (4a) and / or the insulation (4b) is hot-stitched to the connecting element (3).

9. Electrode according to one of claims 7 or 8, wherein the at least one wire (4a) and the insulation (4b) are hot-stitched separately from one another to the connecting element (3).

10. Electrode according to one of claims 1 to 9, wherein the Connecting element (3) is formed in one piece.

11. Electrode according to one of claims 1 to 10, wherein the connecting element (3) has at least one flange-like holding region (3a) for contact with the underside (2a) of the conductor (5) facing the skin and / or the upper side (2b) of the carrier (2) facing away from the skin.

12. Electrode according to one of claims 1 to 11, wherein the connection element (3) has at least one receiving area (3b) for at least partially receiving the signal line (4).

13. Electrode according to one of claims 1 to 12, wherein the connecting element (3) has a connecting region (3c) for connecting the connecting element (3) to the conductor (5) and / or carrier (2).

14. Electrode according to one of claims 1 to 13, wherein the carrier (2) and / or the conductor (5) has an opening (7) for inserting the connection element (3).

15. Electrode according to one of claims 1 to 14, wherein the connecting element (3) is connected to the carrier (2) with the conductor (5) interposed on the underside and the top side of the carrier (2).

16. Electrode according to one of claims 1 to 15, wherein the carrier (2) is coated on the underside (2a) facing the skin with adhesive, preferably a skin adhesive, which is preferably self-adhesive or thermo-activatable, or has a plaster layer provided with an adhesive, preferably a skin adhesive.

17. Electrode according to claim 16, wherein the adhesive is electrically conductive and the contact medium (6) is formed by the adhesive.

18. A method for producing an electrode for application to human skin, in particular according to one of claims 1 to 17, characterized by the following steps: - Arranging, preferably gluing or printing, a conductor (5) on the underside (2a) of an electrically non-conductive carrier (2) facing the skin, - introducing a connecting element (3) into the carrier (2), wherein the connecting element (3) - preferably with a flange-like holding area (3a) - rests on the underside (2a) of the conductor (2) facing the skin and / or the upper side (2b) of the carrier (2) facing away from the skin, - Inserting a signal line (4) into a receiving area (3b) of the connection element (3), and - Hot-staking the receiving area (3b).

19. The method according to claim 18, wherein prior to the introduction of a connecting element (3) a through opening (7) through the carrier (2) and the conductor (5), preferably by punching.

20. Method according to one of claims 18 or 19, wherein a connecting region (3c) - and thus the connecting element (3) with the carrier (2) - is hot-stamped.

21. Method according to one of claims 18 to 20, wherein the following further steps are provided before the introduction of the signal line (4): - coating the underside (2a) of the carrier (2) facing the skin with adhesive, or - applying a plaster layer provided with an adhesive, preferably a skin adhesive, and - introducing a contact medium (6) - preferably a Gel - into a recess of the plaster layer, so that the underlying conductor (5) is contacted.

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