ELECTRODE
20220022793 · 2022-01-27
Inventors
Cpc classification
A61B2562/125
HUMAN NECESSITIES
International classification
Abstract
An electrode for applying to human skin, has an electrically non-conductive support. The support has on its upper side a projecting, electrically conductive connection element with a connection location for the releasable connection of a signal conductor. A conductor is provided, and the conductor is arranged at least to some extent on the opposite, underside of the support and is connected electrically to the connection element and to a contact medium, which is directed towards the skin. The connection element has at least one protrusion, which extends through the support and, at its end, has a widened region formed by deformation. This deformed, widened region makes it possible to establish, on the one hand, an electrical connection between the conductor and the connection element and, on the other hand, a mechanical fastening of the connection element on the support.
Claims
1. An electrode for application to the human skin having an electrically non-conducting carrier which on its top side that faces away from the skin has a projecting electrically conducting connecting element having a connecting location for releasable connection of a signal conductor, wherein there is provided a conductor which is arranged at least partially on the opposite underside of the carrier and which is electrically connected to the connecting element and to a contact medium that faces towards the skin, wherein the connecting element has at least one projection which passes through the carrier and which at its end has an enlarged region formed by deformation, wherein on the one hand an electrical connection between the conductor and the connecting element and on the other hand mechanical fixing of the connecting element to the carrier can be made by that deformed enlarged region.
2. The electrode as set forth in claim 1, wherein the connecting element comprises a single part which has the connecting location for releasable connection of a signal line.
3. The electrode as set forth in claim 1, wherein the connecting element comprises metal, preferably a deep-drawn metal sheet, or conductive plastic, preferably ABS doped with conductive carbon fibers.
4. The electrode as set forth in claim 1, wherein the connecting element has a substantially ball-shaped head, a neck of reduced diameter adjoining same, a holding region which adjoins the end of the neck and which projects laterally in a flange shape and at least one projection adjoining the holding region.
5. The electrode as set forth in claim 1, wherein the at least one projection is formed from at least one first segment and at least one second segment, wherein the at least two segments in a starting position are preferably in a horizontal position or in a vertical position, or wherein at least one of the at least two segments is in a horizontal position and at least a second of the at least two segments is in a vertical position and the flange-like holding region is formed by at least one of the at least two segments.
6. The electrode as set forth in claim 5, wherein the at least one projection is in the form of a spike narrowing in the direction opposite to the holding region.
7. The electrode as set forth in claim 4, wherein the laterally projecting flange-like holding region is of a plate-shaped configuration.
8. The electrode as set forth in claim 1, wherein the connecting element has at least two wing segments, wherein the at least two wing segments have a portion inclined with respect to a horizontal position, wherein the wing segments form the projection and the laterally projecting flange-like holding region, wherein preferably the at least two wing segments are at least portion-wise of a sharp-edged configuration.
9. The electrode as set forth in claim 1, wherein the connecting element is overall of a substantially rotationally symmetrical configuration.
10. The electrode as set forth in claim 1, wherein the conductor is in the form of a conducting plate projecting at least partially beyond the deformed enlarged region.
11. The electrode as set forth in claim 1, wherein the conductor is provided, preferably coated, preferably on one side, with an electrically conducting material.
12. The electrode as set forth in claim 1, wherein the conductor is in the form of a layer comprising a first material, which is provided, preferably coated, with a second material in the region of the contact medium—and preferably only there.
13. The electrode as set forth in claim 12, wherein the second material is an electrically conducting material and is formed by a pair silver/silver chloride or tin/tin chloride or another redox couple suitable for example for depolarization of the electrode.
14. The electrode as set forth in claim 12, wherein the first material is a plastic, in particular a plastic film.
15. The electrode as set forth in claim 12, wherein the first material is of a thickness between 10 μm and 250 μm, preferably a thickness between 30 μm and 100 μm, and the second material is of a thickness between 0.05 μm and 30 μm, preferably a thickness between 0.1 μm and 3 μm.
16. The electrode as set forth in claim 1, wherein the conductor is formed by a layer of a conductive material, which is applied, preferably by printing, to the carrier.
17. The electrode as set forth in claim 1, wherein the conductor is a metal or a metal alloy or a plastic film which is conducting throughout or at the surface for example by conductive carbon fibers or is a textile material which is conducting throughout or at the surface.
18. The electrode as set forth in claim 1, wherein the conductor is of a substantially rotationally symmetrical, in particular ring-shaped configuration.
19. The electrode as set forth in claim 1, wherein the conductor is of a substantially cuboidal configuration.
20. The electrode as set forth in claim 1, wherein the conductor has an opening for introduction of the connecting element.
21. The electrode as set forth in claim 1, wherein the connecting element on the one hand and the contact medium on the other hand are arranged at laterally mutually displaced positions on the carrier.
22. The electrode as set forth in claim 1, wherein the contact medium—preferably arranged in a recess in a plaster layer—is a gel preferably doped with chlorides, is in the form of a conductive adhesive or is in the form of a sponge filled with saline solution.
23. The electrode as set forth in claim 1, wherein the connecting element is connected on the underside and the top side of the carrier to same—preferably with interposition of a flat conductor.
24. The electrode as set forth in claim 1, wherein a plaster layer is provided on an underside of the electrode that faces away from the skin, wherein the plaster layer can be glued on to the skin—preferably by means of a patient-side coating of biocompatible adhesive—in order to fix the electrode.
25. The electrode as set forth in claim 24, wherein the plaster layer can be glued to the carrier by way of a layer of pressure sensitive adhesive that is applied to the plaster layer or the carrier or a thermoactivatable adhesive.
26. The electrode as set forth in claim 1, wherein the carrier comprises a film, in particular of PET.
27. The electrode as set forth in claim 1, wherein the carrier is coated on the side towards the skin with adhesive, preferably a skin adhesive, which is preferably a pressure sensitive adhesive or is thermoactivatable, or has a plaster layer provided with an adhesive, preferably a skin adhesive.
28. The electrode as set forth in claim 1, wherein in the region beside the connecting element the carrier has at least one incision which allows moveability of the connecting element with respect to a plaster layer intended for adhesive bonding to the skin.
29. The electrode as set forth in claim 1, wherein the conductor and the contact medium are formed by separate components and preferably comprise different materials.
30. The electrode as set forth in claim 1, wherein the conductor and the contact medium 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.
31. The electrode as set forth in claim 1, wherein the connecting element, the conductor and/or the contact medium 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.
32. A method of producing an electrode for application to the human skin, in particular as set forth in claim 1, comprising: arranging, preferably gluing or printing, a conductor on the underside, towards the skin, of an electrically non-conducting carrier, introducing a connecting element from the top side of the carrier through same in such a way that the projection of the connecting element projects on the opposite underside of the carrier and the connecting element bears against the top side of the carrier—preferably with a laterally projecting plate-shaped holding region, and deformation of the projection of the connecting element in such a way that there is produced a deformed enlarged region which on the one hand makes an electrically conductive connection between the connecting element and the conductor and on the other hand provides for mechanical fixing of the connecting element to the carrier.
33. The method as set forth in claim 32, wherein prior to introduction of a connecting element a through opening is made through the carrier and the conductor, preferably by stamping.
34. The method as set forth in claim 32, wherein in that a through opening is produced by penetrating the carrier and the conductor by means of the narrowing projection from the side of the carrier, that is remote from the skin.
35. The method as set forth in claim 32, wherein introduction of a connecting element is effected by rotation of the connecting element from the top side of the carrier into the carrier and the conducting plate in such a way that the wing segments pass through the carrier and the conducting plate.
36. The method as set forth in claim 32, wherein deformation of the projection is effected by: fusing of the projection, and/or beading over of the projection, and/or spreading the projection open, and/or bending the projection over.
37. The method as set forth in claim 32, comprising the following further steps: applying—preferably gluing—a plaster layer which is adhesive on the skin side to the carrier, and introducing an electrical contact medium—preferably a gel—into the recess in the plaster layer in such a way that the subjacent conductor is contacted.
38. The method as set forth in claim 32, wherein prior to introduction of the connecting element the carrier is coated over its full surface area or part of its surface area with an adhesive, preferably a skin adhesive.
39. The method as set forth in claim 38, wherein after coating of the carrier with an adhesive, preferably a skin adhesive, an electrical contact medium is applied in such a way that the subjacent conductor is contacted.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] Further advantages and details of the invention are described by means of the specific description hereinafter. In the drawings:
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DETAILED DESCRIPTION OF THE INVENTION
[0062] With reference to
[0063] The basic starting point is an electrically non-conducting carrier 1. The carrier material serves for anchoring the electrical components of the electrode. It can comprise for example a (flexible) film (for example of PET or TPU) which on the underside facing upwardly in the drawing of
[0064] Now in a next step a rotationally symmetrical conductor 3 is fixed on that carrier material, in particular by adhesive or by being printed thereon. In accordance with a preferred variant of the invention the conductor has two differently electrically conducting materials or an electrically non-conducting material 3b and an electrically conducting material 3a, wherein the electrically conducting material 3a or one of the two electrically conducting materials is later galvanically connected to the electrical connecting element 2 and to the contact medium 4 (gel).
[0065] The illustrated embodiment involves a circular conductor 3 of a plastic film, which is shown in black or gray. The conductor 3 however can also comprise a metal or a conductive plastic doped with carbon fibers.
[0066] In the region of the later contact location with the electrical contact medium 4 (gel) that conductor 3 is coated with a layer 3a of for example silver/silver chloride or tin/tin chloride or another redox couple.
[0067] In a further step an opening 8 is now provided through the electrical conductor 3 and the carrier 1. That can be done for example by stamping. The connecting element 2 which has a projection 2b which projects beyond the underside of the carrier 1 and the conductor 3 is then introduced.
[0068] In the illustrated embodiment adjoining the substantially ball-shaped head 2c the connecting element 2 has a neck 2d of reduced diameter, which is adjoined by a holding region 2e projecting laterally in a flange shape, and a projection 2b.
[0069] Overall the laterally projecting flange-shaped holding region 2e is of a substantially plate-shaped configuration. It is responsible for distribution and transmission of pressure forces applied to the connecting element 2, to the carrier 1.
[0070] When using a connecting element 2 which comprises a single part which on the one hand is connected to the electrical conductor 3 and which on the other hand has the connecting location 2a for releasable connection of a signal conductor (not shown here) inexpensive manufacture of the electrode is possible in that way because the generally cost-intensive eyelet (underneath knob) can be omitted. The one-part configuration of the connecting element is sufficient for mechanical anchoring.
[0071] The demands made in terms of the electrical properties are low. In that way it is possible to use simple structures like for example a deep-drawn metal part as the connecting element 2. The somewhat more difficult electrical functions are therefore implemented here not by the otherwise usual eyelet but the conductor 3 which is joined to the electrical contact medium 4 (gel) which is later applied.
[0072] This therefore involves separation of the functions. Apart from the basic property of being electrically conducting the electrical connecting element 2 is substantially responsible for the mechanical hold in the electrode while the conductor 3 is substantially freed of mechanical tasks. That makes it possible to adopt a favorable material. In particular it is possible to provide more costly materials—which are favorable from the electrical point of view—only where (location 3a) contact with the gel later occurs.
[0073] As already mentioned the electrically conducting connecting element 2 can comprise a deep-drawn metal sheet. It is then at least partially hollow in its interior. It can however also comprise a conductive plastic, for example ABS, which is doped with conductive carbon fibers.
[0074] More desirably the connecting element is of a substantially rotationally symmetrical configuration. Other variants are also possible.
[0075] In order to fix the electrical connecting element 2 definitively in the electrode and in particular also to secure it against tensile loadings a next step provides for deforming the projection 2b in such a way as to produce a deformed enlarged region BZ.
[0076] Deformation of the projection 2b can be effected in that case by fusing, beading over, spreading or bending over. It is however also possible to use any other suitable method.
[0077] The deformation of the projection 2b provides that a galvanic connection is made between the connecting element 2 and the conducting material 3a of the conductor by way of the deformed enlarged region BZ while on the other hand mechanical fixing of the connecting element 2 to the carrier 1 is effected by means of positively locking and/or force-locking relationship.
[0078] A plaster layer 7 is now applied to the underside of the carrier 1, in particular by adhesive, wherein the plaster layer can preferably be stuck on the skin by means of a patient-side coating of biocompatible plastic in order to fix the electrode.
[0079] In that respect it is also possible for the plaster layer to be glued to the carrier 1 by way of a layer applied to the plaster layer and comprising pressure-sensitive adhesive or a thermoactivatable adhesive.
[0080] The plaster material ultimately serves to fix the electrode on the patient skin. Suitable plaster materials can comprise for example a film (for example PE), a foam band (for example PE foam) or non-woven materials. The plaster materials are usually coated on the patient side with a biocompatible adhesive.
[0081] In the last step in the production of the electrode shown in
[0082] At any event the electrical contact medium 4, as the last step in
[0083] The cooperation of the electrically conducting material 3a, in particular the coating with silver/silver chloride or another suitable material on the one hand and the material of the electrically conducting contact medium 4 on the other hand makes it possible to achieve favorable electrical properties of the electrode like for example noise-free signal transmission or depolarizing effects, in which case the use of the relatively costly electrically conducting material 3a of the conductor 3 can remain restricted to that region in which contact with the contact medium 4 occurs. That further reduces the costs.
[0084] Overall in the production shown in
[0085] The method steps which are essential for the embodiment shown in
[0089] Finally the following steps are then also implemented to finish the electrode: [0090] applying—preferably gluing—a plaster layer (7) which is adhesive on the skin side to the carrier (1), and [0091] introducing an electrical contact medium (4)—preferably a gel—into the recess in the plaster layer (7) in such a way that the subjacent conductor (3) is contacted.
[0092] In the embodiment shown in
[0093] The difference is essentially that there is provided a “decentral” electrode. In other words, the contact medium 4 on the one hand and the connecting element 2 on the other hand are displaced relative to each other in a horizontal plane H.
[0094] In such an embodiment it is necessary to provide an electrically conducting transverse conductor 10 which makes a galvanic connection between the conductor 3 and the connecting element 2.
[0095] In deformation of the projection 2b pressure can be exerted on the layers so that they are correspondingly contoured and interconnected. The cross-section shown in
[0096] It can further be seen that the deformed enlarged region BZ can also no longer be circular but of a lamellar configuration. The deformed enlarged region BZ can basically be of any desired shape.
[0097] In the embodiment shown in
[0098] The difference is substantially that there is provided on the carrier 1 a biocompatible adhesive layer 11 for attaching the electrode to the skin of a patient. The plaster layer 7 can thus be eliminated and a further process step is saved.
[0099] In this case the adhesive layer 11 can be applied prior to or after application of the conductor 3 to the carrier 1 or the adhesive layer 11 is already provided on the starting material of the carrier 1.
[0100] The above-mentioned variants for applying the adhesive 11 are shown in
[0101] In
[0102] In
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[0105] For that purpose in a first step the connecting element 2 is pushed from a top side of a carrier 1, that later faces away from the skin, through the carrier 1 and the conductor 3 (not shown) which is attached to the underside of the carrier 1. This means that the connecting element 2 penetrates the carrier 1 and the conductor 3 with the wing segment portions 9a.
[0106] In a next step the connecting element 2 is rotated in a direction D. That provides for better anchorage of the connecting element 2 in the carrier 1.
[0107] In a last step the wing segment portions 9a are bent up in the direction of the underside of the carrier 1 beyond a horizontal position H whereby the carrier 1 and the conductor 3 are clamped. This also ensures an electrical connection of the connecting element 2 to the conductor 3 and a mechanical fixing of the connecting element 2 on the carrier 1. It will be appreciated however that it is also possible for the wing segment portions to be only bent up until they are in a horizontal position H.
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[0111] It can also be seen that the second segments 6 are longer than the first segments 5. The segments 5, 6 can also be of equal length or the segments 5 can be longer than the segments 6.
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[0115] In a connecting element 2 as shown in
[0116] In an embodiment of a connecting element 2 as shown in
[0117] In the previous embodiments shown in
[0118] There is however also the possibility of the conductor 3 and the contact medium 4 being formed by one and the same component, preferably by an electrically conducted adhesive, so that it is possible to save overall on components. That is described in greater detail hereinafter with reference to
[0119] In the embodiment shown in
[0120] In the embodiment shown in
[0121] In the embodiment shown in
[0122] Additionally in a last step an also adhesive plaster material 7 having a central opening is applied, through which the electrically conductive adhesive is still free as the contact medium. Overall therefore adhesive connection to the skin is effected on the one hand by way of the adhesive plaster material 7 and on the other hand by way of the electrically conductive adhesive 12. The advantage of the variant shown in
[0123] In the embodiments of the invention it is possible in particular for a second layer of the conductor—as described above—to be formed by a layer of silver/silver chloride or tin/tin chloride or another redox couple.
[0124] It is however also possible that in addition other electrically conducting components are provided with such redox couples, in particular also the contact medium 4 and/or the connecting element 2. In the sense of economically managing with the relatively costly redox components not all conductive elements will be simultaneously provided with such redox couples, although that is also theoretically possible. As already mentioned, it is sufficient if a second layer of the conductor 3 is provided with such a redox couple. In principle it is also possible to save on the redox couples entirely and to provide that neither the connecting element 2 nor the conductor 3 nor the contact medium 4 contains such a redox couple.
LIST OF REFERENCES
[0125] 1 carrier [0126] 2 connecting element [0127] 2a connecting location [0128] 2b projection [0129] 2c head [0130] 2d neck [0131] 2e holding region [0132] 2f lower holding region [0133] 3 conductor [0134] 3a electrically conducting material [0135] 3b electrically non-conducting material [0136] 4 contact medium [0137] 5 first segment [0138] 6 second segment [0139] 7 plaster layer [0140] 8 opening [0141] 9 wing segment [0142] 9a wing segment portion [0143] 10 transverse conductor [0144] 11 adhesive layer (skin adhesive) [0145] 11a opening [0146] 12 electrically conductive adhesive [0147] H horizontal [0148] V vertical [0149] BZ deformed enlarged region