Electrodes for attachment to human skin

Abstract

An electrode (1) for attachment to human skin, comprising a non-conductive support (2) and a conductive connection element (3) for connecting a signal conductor (4), the electrode (1) being provided with a conductor (5) at least partially disposed on a lower surface (2a) of the support (2) that is to face the skin, the conductor (5) being electrically connected to the connection element (3) and a contact medium (6) that is to face the skin, the connection element (3) being heat staked to the signal conductor (4) and / or the conductor (5).

Description

[Technical Field]

[0001] The present invention relates to an electrode for attachment to human skin, comprising a non-conductive support and a conductive connection element for connecting a signal conductor, with a conductor at least partially arranged on the underside of the support that is to face the skin, the conductor being electrically connected to the connection element and to a contact medium that is to face the skin, and to a method for manufacturing an electrode for attachment to human skin.

[0002] Such electrodes are already known from the prior art. Here, the conductor is generally a metal foil. In this case, the signal conductor is riveted to the conductor and the support, thereby forming an electrical connection on the one hand and a mechanical connection on the other hand between the conductor / support and the signal conductor. The disadvantage here is that riveting the signal conductor to the conductor / support is relatively time-consuming.

[0003] In examinations using various X-ray methods, it is often desirable to collect additional data during the examination by means of measuring electrodes or to monitor certain patient parameters, but the electrodes described above are not suitable for this, since their metallic components may cast shadows on the X-ray image, making it unsuitable for further analysis.

[0004] To avoid this, it is known to make the conductors from radiolucent materials, such as carbon fiber or conductive plastics, so that the influence of the electrodes on the X-ray image is minimized, but in this case, metal conductors and connecting elements are often also used, which are also visible on the X-ray image.

[0005] If radiolucent signal conductors are provided, they are typically glued to the conductors. For this purpose, the core wires of the signal conductors are fanned out and glued to the conductors using glue and / or adhesive tape. This fanning is used to ensure the best possible electrical connection between the signal conductors. This type of connection is laborious and has relatively low mechanical strength.

[0006] SUMMARY OF THE INVENTION It is an object of the present invention to at least partially overcome the above-mentioned drawbacks and to provide an electrode and a method for producing an electrode which are improved over the prior art.

[0007] The above problem is solved by the features of independent claims 1 and 18.

[0008] Therefore, according to the invention, the connection element is configured to be heat staked to the signal conductor and / or the conductor.

[0009] Heat staking provides a simple and uncomplicated means for electrically and mechanically connecting the signal conductor and / or conductor to the connecting element, and thus the signal conductor to the conductor via the connecting element, whereby a positive and force-locking connection is produced, which also ensures sufficient mechanical strength.

[0010] With regard to the method according to the invention, the following method steps are involved: - placing, preferably by gluing or printing, a conductor on the underside of the non-conductive support that is to face the skin; - introducing the connection element into the support, so that the connection element abuts - preferably with a flange-shaped holding area - against the underside of the conductor that is to face the skin and / or against the upper side of the support facing away from the skin; - introducing a signal conductor into the receiving area of ​​the connection element; - heat staking the containment area; The method can be configured to include:

[0011] Heat staking is significantly simpler and faster than gluing and riveting the signal conductor to the conductor / support, allowing electrodes to be fabricated in a shorter time, which also provides economic advantages.

[0012] Further advantageous embodiments of the invention are defined in the respective dependent claims.

[0013] Particularly preferably, the electrodes can be configured to be at least partially radiolucent, which allows them to be used for measurements during X-ray examinations.

[0014] Preferably, the connection elements can be configured to be made from conductive plastic and / or carbon fiber.

[0015] Additionally, the conductors can be configured to be made from conductive plastic and / or carbon fiber.

[0016] Finally, the signal conductors can be configured to be at least partially made from conductive plastic and / or carbon fiber.

[0017] This is a simple way to make the conductive parts of the electrode radiolucent. It is particularly advantageous if the connection elements, conductors and signal conductors are made from conductive plastic and / or carbon fiber, since this allows the electrode to be completely radiolucent.

[0018] The conductor can also be configured so that it is coated on the side facing the contact medium with a silver / silver chloride couple, a tin / tin chloride couple or another redox couple suitable for example for polarizing the electrode.

[0019] The redox couples used here are used in electrodes to achieve low noise and depolarization during defibrillation. The electrodes are oxidizable and reducible, absorbing or releasing at least one electron. Silver / silver chloride, tin / tin chloride, and tin-antimony are most frequently used. However, the present invention contemplates any redox couple that allows electrode depolarization. In this case, the redox couple can be actively added or, in some cases, generated in situ by a reaction.

[0020] The signal conductor may be configured to have at least one core and an insulation portion.

[0021] Additionally, at least one of the conductors and / or the insulation can be configured to be heat staked to the connection element.

[0022] The core wire provides both an electrical and mechanical connection between the signal conductor and the connection element, and if the insulation is also heat-stakingly attached to the connection element, a more stable mechanical connection can be achieved.

[0023] According to one embodiment, at least one conductor and the insulation may be heat staked separately from each other to the connection element.

[0024] This allows the insulation to act as a strain relief for the signal conductors.

[0025] In principle, it is also conceivable that the connection element or parts of the connection element are integral components of the signal conductor, for example, the connection element or parts thereof may be injection-molded onto the signal conductor during its production by injection molding.

[0026] The connection element can be configured to be integrally formed.

[0027] This is the simplest and cheapest construction of the connection element, although it is of course also conceivable for the connection element to be made up of several parts.

[0028] Advantageously, the connection element can be configured to have at least one flange-like holding area abutting the lower surface of the conductor that is to face the skin and / or the upper surface facing away from the skin.

[0029] This facilitates the manufacture of the electrode, since the connection element can be fixed to the electrode via the holding area, which in turn provides high stability in the area of ​​connection with the signal conductor.

[0030] Preferably, the connection element is configurable to have at least one receiving area for at least partially receiving a signal conductor.

[0031] In this case, the receiving area can be formed by a simple opening or by a slit, although in principle, various different embodiments of the receiving area are conceivable.

[0032] The connection element may also be configured to have a connection area for connecting it to the conductor and / or the support.

[0033] The connection area can also have various shapes, the simplest being a pin which in this case is heat staked.

[0034] If the support and / or the conductor have openings for introducing the connection elements, the connection elements can be easily and reliably connected to the support and / or the conductor.

[0035] Furthermore, the connection element may be configured to be connected to the support with conductors interposed between the lower and upper surfaces of the support.

[0036] This makes it possible to ensure the best possible mechanical connection between the connection element and the support.

[0037] Preferably, the support can be configured so that on its underside, which is to face the skin, it is coated with an adhesive, preferably a skin adhesive, which is preferably formed to be self-adhesive or heat-activatable, or has a plaster layer on which an adhesive, preferably a skin adhesive, is provided.

[0038] This is a simple means for placing electrodes on the patient.

[0039] Particularly preferably, the adhesive is electrically conductive and the contact medium can be configured to be formed by the adhesive.

[0040] Therefore, the structure and manufacturing of the electrode can be simplified.

[0041] The method can be arranged such that, before the introduction of the connection element, through-openings are formed through the support and the conductor, preferably by stamping.

[0042] A connecting element can then be introduced into the opening.

[0043] It is also possible to provide that the connection region and thus the connection element are heat-stakingly secured to the carrier.

[0044] This is a simple means of connecting the connection element to the support.

[0045] Also, the following further steps: - coating the underside of the support that is to face the skin with adhesive, or - applying a layer of plaster provided with an adhesive, preferably a skin adhesive; - introducing a contact medium, preferably a gel, into the recess of the plaster layer so as to contact the underlying conductor; It can also be configured to perform the following.

[0046] Further details and advantages of the invention will be explained in detail below with reference to the drawings, which are included in the description of the figures, in which: [Brief explanation of the drawings]

[0047] [Figure 1] 1A-1C are schematic diagrams showing the manufacturing process of one embodiment of an electrode (side that will later face the skin) viewed from below. [Figure 2] 1A-1C are schematic plan views illustrating the manufacturing steps of one embodiment of an electrode, where only some of the process steps are shown in top view. [Figure 3] 2 is a schematic diagram showing a sequence of cross sections taken along line AA in FIG. 1. [Figure 4] 10A-10C are schematic diagrams showing the manufacturing process of another embodiment of an electrode (the side that will later face the skin) as viewed from below. [Figure 5] 1 is a schematic diagram showing a top view of the manufacturing process of another embodiment of an electrode, where only some of the process steps are shown in top view. [Figure 6] 5 is a schematic diagram showing a sequence of cross sections taken along line AA in FIG. 4. [Figure 7] 7a to 7e are schematic diagrams showing various embodiments of the connection element.

[0048] The flow of a method for manufacturing an electrode 1 according to one embodiment of the present invention for attachment to human skin will be described in more detail below with reference to FIGS.

[0049] We start with a non-conductive support 2. The support material serves to fasten the electrical components of the electrode 1. The support material may consist, for example, of a (flexible) film (for example PET or TPU).

[0050] In a next step, conductors 5 are applied to the carrier material, which in this example completely cover the carrier 2. It is also conceivable that the conductors 5 are applied only to specific locations on the carrier 2. In particular, the conductors 5 are glued or printed.

[0051] The conductor 5 is made of carbon fiber or conductive plastic in this embodiment, but may also be made of metal if radiolucency is not desired.

[0052] In this embodiment, the conductor 5 is coated with a layer 5a, for example consisting of silver / silver chloride, tin / tin chloride, tin-antimony or other redox couple.

[0053] Now, in a further step, openings 7 are provided through the electrical conductors 5 and the support 2. This can be done, for example, by punching. The introduction of the connection elements 3 then follows.

[0054] In the illustrated embodiment, the connecting element 3 has a cylindrical section to which a laterally projecting flange-like holding area 3a is connected. In this embodiment, both the receiving area 3b and the connecting area 3c are formed adjacent to or through the cylindrical section. Overall, the laterally projecting flange-like holding area 3a is substantially dish-shaped.

[0055] In this way, an inexpensive production of the electrode is possible if a single-piece connecting element 3 is used: the one-piece construction of the connecting element 3 is sufficient for mechanical fixation.

[0056] In a next step, the underside 2a of the support 2 is provided with a coating of a biocompatible adhesive, which makes it possible to fix the electrode 1 to the patient's skin.

[0057] In this embodiment, the biocompatible adhesive is electrically conductive and therefore acts as the contact medium 6. The electrical contact medium 6 allows electrical potentials generated in the body or measuring or stimulating currents generated in the device to be conducted (preferably ionically) from the body surface (skin) to the electrical connection element 3 and vice versa.

[0058] Alternatively, it is also conceivable to apply a plaster layer which is used to fix the electrode 1 to the patient's skin. In this case, the contact medium 6 may consist, for example, of a chloride-doped gel, which is present in a more or less liquid (more or less gelled) form or as a crosslinked polymer matrix (hydrogel).

[0059] Suitable plaster materials may consist, for example, of a film (e.g. PE), a foam tape (e.g. PE foam) or a nonwoven fabric. The plaster material is usually coated with a biocompatible adhesive on the patient side.

[0060] Furthermore, a rivet insulation 6a is applied, which insulates the area where the connection element 3 is located from the patient's skin, thereby preventing excessive stress on the patient's skin below the connection element 3.

[0061] In a further manufacturing step of the electrode according to FIGS. 1 to 3, a cover 8 is applied which protects the contact medium 6 until the electrode 1 is used.

[0062] In a next step, the signal conductor 4, in this example only the conductor 4a, is introduced into the receiving area 3b of the connection element 3. For this purpose, the receiving area has an opening through which the signal conductor 4 can be introduced.

[0063] In order to finally fix the electrical connection element 3 within the electrode 1 and form a conductive connection between the signal conductor 4 and the conductor 5, in the next step the signal conductor 4 in the accommodating area 3b is heat-stakingly attached to the connection element 3, and the support 2 and the conductor 5 are heat-stakingly attached to the connection element 3 in the connection area 3c.

[0064] In this case, heat staking can typically be done via a heated stamp or contactlessly using laser or infrared radiation.

[0065] In this embodiment, after the receiving area 3b and the connecting area 3c are assembled and formed, only one heat staking process is required, which allows for a simple and quick formation of the electrode 1. The heat staking process forms a rivet head, which functions as the holding area 3a.

[0066] In the embodiment shown in Figures 4-6, many method steps correspond to those shown in Figures 1-3, and therefore like reference numerals refer to like elements.

[0067] The difference is mainly that a different embodiment of the connecting element 3 is used.

[0068] It can be seen that the connection element 3 is now formed from two parts. The lower part is similar to the connection element 3 according to FIGS. 1 to 3 and has a holding area 3a and a cylindrical section. The upper part also has a holding area 3a, except that the upper holding area 3a has an opening for receiving the cylindrical section. The cylindrical section forms the connection area 3c together with the corresponding opening.

[0069] In the upper part, a section similar to a conductor end sleeve can also be seen, which forms the receiving area 3b.

[0070] In this embodiment, multiple heat staking steps are required: once to heat stake the connection area 3c to the support 2 and the conductor 5, thereby forming a mechanical connection between the connection element and the support, and an electrical connection between the connection element 3 and the conductor 5.

[0071] Furthermore, the receiving area 3b of the connection element 3 is heat-stakingly attached to the signal conductor 4. At this time, the core 4a and the insulator 4b are heat-stakingly attached to the connection element 3 separately from each other. The separate connection of the core 4a and the insulator 4b allows strain relief of the signal conductor 4 to be achieved.

[0072] 7a to 7e show various embodiments of the connection element 3 in a schematic manner.

[0073] 1 to 3, but differs from the connection element 3 according to Fig. 7a in that it further comprises a protrusion in the extension of the opening for accommodating the signal conductor 4. The protrusion is used to accommodate the insulating part 4b of the signal conductor 4, which makes it possible to achieve additional mechanical stability in the connection between the signal conductor 4 and the connection element 3.

[0074] 7b has a slit for receiving the signal conductor 4, into which the wire 4a of the signal conductor 4 can be introduced. In this embodiment too, the receiving area 3b and the connection area 3c are combined.

[0075] The embodiment according to Fig. 7c corresponds to the embodiment shown in Fig. 4 to 6. The embodiment according to Fig. 7d is very similar to the embodiment according to Fig. 7c, but in the connection region 3b a snap connector is provided for connecting the connection element 3 to the support 2 and the conductor 5. In this embodiment, only the signal conductor 4 is heat-staken to the connection element 3.

[0076] The connection element 3 according to FIG. 7e is another variant of the embodiments according to FIGS. 7c and 7d. Here, the connection element 3 is again made in one piece and has only one holding area 3a. The cylindrical section is oriented downwards and connected to the holding area 3a. The connection element according to FIG. 7e is introduced into the support body 2 from the upper surface 2b rather than from the lower surface 2a. The connection element 3 can be connected to the support body 2 and the conductor 5 by heat staking the cylindrical section. During heat staking, a rivet head is formed, thereby forming the holding area 3a on the lower surface 2a of the support body 2, which also forms an electrical contact connection to the conductor.

[0077] 7a-e show, by way of example only, various means for forming the connection element 3. Of course, many other configurations of the connection element are also conceivable within the scope of the invention. [Explanation of symbols]

[0078] 1 electrode 2 Support 2a Bottom side 2b Top side 3 Connecting Elements 3a Holding area 3b Containment area 3c Connection Area 4 signal conductors 4a core wire 4b Insulation part 5 Conductors 5a Coating, Redox Couple 6 Coupling medium 6a Rivet insulation 7 aperture 8 Cover

Claims

1. An electrode (1) for attachment to human skin, comprising: It comprises a non-conductive support (2) and a conductive connection element (3) for connecting a signal conductor (4), a conductor (5) at least partially disposed on the lower surface (2a) of the support (2) to be exposed to the skin, the conductor (5) being electrically connected to the connection element (3) and a contact medium (6) to be exposed to the skin; In the electrode (1), The connection element (3) is heat-stakingly attached to the signal conductor (4) and / or the conductor (5). An electrode (1).

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

3. 3. The electrode according to claim 1, wherein the connecting element (3) is made of conductive plastic and / or carbon fiber.

4. 4. The electrode according to claim 1, wherein the conductor (5) is made of conductive plastic and / or carbon fiber.

5. 5. The electrode according to claim 1, wherein the signal conductor (4) is at least partially made of conductive plastic and / or carbon fiber.

6. 6. The electrode according to claim 1, wherein the conductor (5) is coated on the side facing the contact medium (6) with a silver / silver chloride couple, a tin / tin chloride couple or another redox couple suitable for example for depolarizing the electrode (1).

7. 7. The electrode according to claim 1, wherein the signal conductor (4) comprises at least one core (4a) and an insulating portion (4b).

8. 8. The electrode according to claim 7, wherein the at least one core (4a) and / or the insulation (4b) are heat-stakingly attached to the connection element (3).

9. 9. The electrode according to claim 7 or 8, wherein the at least one core (4a) and the insulating portion (4b) are heat-stakingly secured to the connection element (3) separately from one another.

10. 10. The electrode according to claim 1, wherein the connection element (3) is formed in one piece.

11. 11. The electrode according to claim 1, wherein the connecting element (3) has at least one flange-shaped holding area (3a) which abuts against a lower surface (2a) of the conductor (5) that is to face the skin and / or against an upper surface (2b) of the support (2) facing away from the skin.

12. 12. The electrode according to claim 1, wherein the connection element (3) has at least one receiving area (3b) for at least partially receiving the signal conductor (4).

13. 13. The electrode according to claim 1, wherein the connection element (3) has a connection region (3c) for connecting it to the conductor (5) and / or the support (2).

14. 14. The electrode according to any one of claims 1 to 13, wherein the support (2) and / or the conductor (5) have an opening (7) for introducing the connection element (3).

15. 15. The electrode according to claim 1, wherein the connection element (3) is connected to the support (2) on the lower and upper sides thereof with the conductor (5) interposed therebetween.

16. 16. The electrode according to claim 1, wherein the support (2) is coated on its underside (2a) facing the skin with an adhesive, preferably a skin adhesive, which is preferably self-adhesive or heat-activatable, or has a plaster layer containing an adhesive, preferably a skin adhesive.

17. 17. The 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 manufacturing an electrode for attachment to human skin, in particular according to any one of claims 1 to 17, comprising the following steps: - placing, preferably by gluing or printing, a conductor (5) on the underside (2a) of the non-conductive support (2) that is to face the skin; - introducing a connecting element (3) into the support (2) so that the connecting element (3) - preferably with a flange-shaped holding area (3a) - abuts against the underside (2a) of the conductor (2) that is to face the skin and / or against the upper side (2b) of the support (2) facing away from the skin; - introducing a signal conductor (4) into the receiving area (3b) of said connection element (3); - heat staking said receiving area (3b); A method comprising:

19. 19. Method according to claim 18, characterized in that before the introduction of the connection element (3), through-openings (7) are formed through the support (2) and the conductor (5), preferably by stamping.

20. 20. The method according to claim 18 or 19, wherein the connection region (3c) and thus the connection element (3) are heat staked to the support (2).

21. Before the introduction of said signal conductor (4), the following further steps are carried out: - coating the underside (2a) of said support (2) that is to face the skin with adhesive, or - applying a layer of plaster provided with an adhesive, preferably a skin adhesive; - introducing a contact medium (6), preferably a gel, into the recess of the plaster layer so as to contact the underlying conductor (5); 21. The method according to any one of claims 18 to 20, wherein

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