IMPLANTABLE ELECTRODE ARRANGEMENT

20170319846 · 2017-11-09

    Inventors

    Cpc classification

    International classification

    Abstract

    An implantable electrode arrangement provides spatially-selective detection of neuronal electrical signals, which propagate along at least one nerve fiber contained in a nerve fascicle, and for selective electrical stimulation of the at least one nerve fiber, comprising a biocompatible carrier substrate, which has at least one carrier substrate region that can be placed around the nerve fascicle in a cuff and has a straight cylinder-shaped carrier substrate surface which faces the nerve fascicle in the implanted state. The carrier substrate surface has an axial extension and an extension oriented circumferentially in a direction and a first electrode arrangement attached thereto. The electrode arrangement comprises in an axial sequence, at least three first electrode structures with at least two first electrode surfaces arranged in the circumferentially, and at least two spaced first electrode strips, displayed in the axial direction which extend circumferentially which are in a ring shape, which encloses the at least three electrode structures on both sides in the axial direction. The electrodes are connectable or are connected to a signal detector and generator.

    Claims

    1-30. (canceled)

    31. An implantable electrode arrangement for spatially-selective detection of neuronal electrical signals, which propagate along at least one nerve fiber contained in a nerve fascicle, and for selective electrical stimulation of the at least one nerve fiber, comprising: a biocompatible carrier substrate, including at least one carrier substrate region placeable around the nerve fascicle as a cuff, and having a cylindrical carrier substrate oriented to face the nerve fascicle in an implanted state, an axial extension, circumferential extension and a first electrode arrangement attached thereto, the electrode arrangement including, at least three axially spaced first electrode structures with each first electrode structure comprising at least two first electrode surfaces disposed circumferentially; at least two axially spaced apart first electrode strips which assume a ring shape, the first electrode strips enclosing the at least three electrode structures on both sides in an axial direction and being connectable or connected to a signal detector and generator; at least one second electrode arrangement spaced from the first electrode arrangement and facing the nerve fascicle including at least two spaced apart second electrode strips which have an annular shape and at least one second electrode structure, extending axially between the at least two second electrode strips and each comprising at least two second electrode surfaces which are equally spaced circumferentially; and wherein the second electrode arrangement is connected at least with the signal detector and generator or to another signal generator.

    32. The electrode arrangement according to claim 31, wherein: the first and second electrode surfaces are equally distributed circumferentially when implanted.

    33. The electrode arrangement according to claim 31, wherein: the first and second electrode surfaces each extend axially and extend circumferentially; the extensions of the first electrode surfaces are identical; the extensions of the second electrode surfaces are identical; and the extensions of the second electrode surfaces which are oriented circumferentially is greater than the extension of the first electrode surfaces which are oriented circumferentially.

    34. The electrode arrangement according to claim 33, wherein: the axial extension of the first and second electrode surfaces are identical.

    35. The electrode arrangement according to claim 31, wherein: a carrier substrate surface to which the first and second electrode arrangement are applied and is a continuous single piece.

    36. The electrode arrangement according to claim 31, comprising: an axial spacing between the first electrode strips which is equal to or greater than the axial spacing between the second electrode strips; and an axial spacing between the second electrode strips is between 0.5 cm and 3 cm.

    37. The electrode arrangement according to claim 36, wherein the axial spacing between the second electrode strips is between 0.75 cm and 1.25 cm.

    38. The electrode arrangement according to claim 31, wherein: a shape and size of the first and second electrode strips is identical; and an area of the first and second electrode surfaces is smaller than an area of the first or second electrode strips.

    39. The electrode arrangement according to claim 38, wherein an area of the first or second electrode strips is less than one quarter of an area of the second electrode strips.

    40. The electrode arrangement according to claim 31, wherein: the first electrode surfaces are metallic and have a higher charge transfer capacity than a material from which the second electrode surfaces are made.

    41. The electrode arrangement according to claim 40, wherein: the first electrode surfaces comprises iridium oxide; and the second electrode surfaces are metallic or are an electrically conductive polymer.

    42. The electrode arrangement according to claim 31, wherein: the first and second electrode arrangements comprise a tripolar electrode arrangement, with first and second electrode strips each being polarized with an opposite polarity relative to the first and second electrode structure.

    43. The electrode arrangement according to claim 31, comprising: at least one optical waveguide is part of a region of the second electrode arrangement and comprises at least two separate light wave conductor openings which are distributed circumferentially.

    44. The electrode arrangement according claim 43, wherein: the light wave conductor openings are equally distributed circumferentially; and the light wave conductor openings include an axial extension and circumferential extension corresponding to an extension of the second electrode surfaces.

    45. The electrode arrangement according to claim 31, wherein: the first electrode surfaces and the first electrode strips of the first electrode arrangement and the second electrode surfaces and the second electrode strips of the second electrode arrangement are attached to the carrier substrate surface but do not protrude beyond the carrier substrate surface.

    46. The electrode arrangement according to claim 31, wherein: the carrier substrate comprises at least one biocompatible polymer having an active substance inhibiting inflammation reactions at least in regions on the cylindrical carrier substrate surface facing the nerve fascicle.

    47. The electrode arrangement according to claim 31, comprising: at least the signal detector and generator, the second signal detector and an electrical power supply unit are hermetically enclosed separately from the carrier substrate within a housing or are integral parts of the carrier substrate.

    48. The electrode arrangement according to claim 31, wherein: the carrier substrate contains a biocompatible polymer.

    49. The electrode arrangement according to claim 48, wherein: at least one of the first and second electrode strips have at least one local opening, and at least one of the first and second electrode strips are connected in planar configuration to the carrier substrate surface with the polymer penetrating through the at least one opening.

    50. The electrode arrangement according to claim 31, wherein: at least two reference electrode surfaces are attached to the carrier substrate on a rear side thereof in relation to the carrier substrate surface.

    51. The electrode arrangement according to claim 31, wherein: the biocompatible carrier substrate in a region of the straight cylindrically-shaped carrier substrate surface oriented to face the nerve fascicle has edge regions disposed opposite one another axially, at which the carrier substrate has a greater substrate thickness than in any other carrier substrate region; and the edge regions have rounded edges.

    52. The electrode arrangement according to claim 31, wherein: the biocompatible carrier substrate has a carrier substrate region that cannot be placed around the nerve fascicle in a cuff and has at least one fastening opening fully penetrating the carrier substrate.

    53. The electrode arrangement according to claim 52, wherein: the at least one fastening opening is surrounded by a metal material.

    54. The electrode arrangement according to claim 48, wherein: at least one of the first and second electrode strips has a metal base plate with a flat upper side and flat lower side, with at least one element protruding orthogonally beyond the upper side; the flat surface of the metal base plate is oriented parallel to the carrier substrate surface; and the metal base plate is encased by the biocompatible polymer with an exception of a first surface region of the at least one element which is oriented to face the carrier substrate surface and does not protrude therebeyond.

    55. The electrode arrangement according to claim 54, wherein: an adhesion layer is introduced at least between the lower side of the metal base plate and the biocompatible polymer of the carrier substrate.

    56. The electrode arrangement according to claim 54, wherein: the first surface region of the at least one element or a plane associated with the first surface region is oriented parallel to the carrier substrate surface with the first surface region being accessible from sides of the carrier substrate surface and at least one structural element is integrally connected to the metal base plate.

    57. The electrode arrangement according to claim 54, wherein: identical elements as disposed on an upper side of the metal base plate in a geometric pattern.

    58. The electrode arrangement according to claim 54, wherein: the at least one structural element comprises a pillar, a rib, a sleeve or a web.

    59. The electrode arrangement according to claim 54, wherein: the at least one structural element has a longitudinal extension oriented orthogonally to an upper side of the metal base plate along which the extension of the structural element provides at least one second surface region, which is oriented parallel to the upper side of the metal base plate and to which the adhesion layer or an adhesion layer arrangement is applied; and the second surface region is spaced from the first surface region and is surrounded completely by the biocompatible polymer.

    60. The electrode arrangement according to claim 31, wherein: the carrier substrate is surrounded by a cuff which at least in a region of the carrier substrate which does not contain the carrier substrate surface.

    61. The electrode structure according to claim 53, wherein: the cuff has an upper side and a lower side which are connected to one another in a hinge; and the upper side and the lower side each have fastening openings which are congruent to the fastening openings of the carrier substrate in the cuff surrounding the carrier substrate.

    62. The electrode structure according to claim 48, wherein: the carrier substrate has a thickness oriented orthogonal to the carrier substrate surface and the base plate is disposed centrally in relation to the substrate thickness.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0036] The invention will be described hereinafter by way of example, without limitation of the general inventive concept, on the basis of exemplary embodiments with reference to the drawings, in which:

    [0037] FIG. 1 shows a plan view of a schematic implantable electrode arrangement with a second electrode arrangement for the inhibition of selective nerve fibers;

    [0038] FIGS. 2a and b show illustrations of an implantable electrode arrangement, known per se, for the spatially-selective detection of neuronal electrical signals and also selective electrical stimulation of individual nerve fibers;

    [0039] FIG. 3a shows an illustration of an electrode strip with opening;

    [0040] FIG. 3b shows a detailed illustration of an electrode strip integrated in the carrier substrate;

    [0041] FIG. 3c shows an alternative design of a structural element;

    [0042] FIGS. 4a-f show illustrations of a cuff additionally strengthening the implantable electrode arrangement; and

    [0043] FIG. 5 shows hydraulic application structures of the implantable electrode arrangement.

    DETAILED DESCRIPTION OF THE INVENTION

    [0044] FIG. 1 shows a schematic plan view of an implantable cuff electrode CE formed in accordance with the invention, with a second electrode arrangement 7 for the inhibition of at least one selective nerve fiber being applied to the carrier substrate 1 of the cuff electrode. The carrier substrate is preferably made of polyimide. In addition the first electrode arrangement 2 is provided for the spatially-selective detection of neuronal electrical signals and also for selective electrical stimulation of individual nerve fibers. In order to avoid repetition, reference is made to the above description of FIGS. 2a and b with regard to the explanation of the individual electrodes of the first electrode arrangement 2.

    [0045] The second electrode arrangement 7, for inhibiting the signal propagation along efferent nerve fibers, which here are nerve fibers leading to the heart H, comprises two axially spaced-apart second electrode strips 8, between which there is provided, centrally, a second electrode structure 13, which has four second electrode surfaces 9 arranged separately from one another. All electrodes 8 and 13 of the second electrode arrangement 2 are connected or connectable via electrical conductive tracks L applied to the carrier substrate 1 or integrated therein to a signal generator 6′, which together with the signal detector and generator 6 and also with a power source is integrated in a separately encapsulated, implantable unit. The electrical conductive tracks L can optionally comprise a separable connection structure V.

    [0046] The second electrode arrangement 2 optionally comprises light wave conductor arrangements 10, which in each case comprise four separate light wave conductor openings 11 distributed circumferentially in direction U. The light wave conductors LI run within the carrier substrate 1 to the individual light wave conductor openings or apertures 11 and can be combined proximally with a uniform light source LQ or with separate light sources LQ of different wavelengths so as to bring about optogenetically selectively activated stimulations and/or optically activated and selective inhibition along specific nerve fibers.

    [0047] The geometric selection of the shape and size of the individual electrodes, that is of the first and second electrode strips 5 and 8 and also of the first and second electrode surfaces 4 and 9 can be made in principle in a manner coordinated individually with one another and is based in particular on the diameter of the nerve fascicle so as to be able to place the implantable cuff electrode CE in position. The extent of the first and second electrode structures and electrode strips oriented in the circumferential direction U and also possibly the optical light wave conductor arrangements 10 thus preferably corresponds to the circumferential edge of the nerve fascicle around which the cuff electrode CE is to be wound. The axial spacing of the tripolar electrode arrangement should preferably be adapted to the diameter and the resultant spacing of what are known as the nodes of Ranvier in myelinated nerve fibers of the nerve fibers to be excited. In the exemplary embodiment illustrated in FIG. 1, the electrodes are illustrated as rectangular electrode surfaces. It is advantageous to form the electrode surfaces at least with rounded corners, in particular for the purpose of avoiding field line densifications occurring at electrode rectangle corners.

    [0048] In humans, it is necessary to inhibit or to activate specific, large and myelinated fibers. This is possible only at points along the nerve fibers at which these fibers are not myelinated, that is at what are known as nodes of Ranvier. With increasing diameter of the nerve fibers, the intervals, that is the axial distances between the nodes of Ranvier, become larger, and accordingly it is necessary to select the axial spacing between two axially distanced first electrode strips 5 to be approximately the same length as the axial spacing of the rings or slightly greater so as to also reach the nodes of Ranvier of very large fibers with sufficiently high statistical probability. The same is preferably also true for the axial spacing of the second electrode strips 8.

    [0049] The axial total extent of the entire cuff electrode CE should be adapted to the intracorporeal proportions of the particular nerve fascicle and typically should not exceed 4 cm.

    [0050] The additional reference electrode surfaces 12 attached to the carrier substrate 1 on the rear side serve to detect the noise level which is detectable intracorporeally, and thus ECG signals as necessary.

    [0051] The carrier substrate 1 additionally has at least one and preferably two or three openings 14 which are strengthened by metal ring structures The openings serve to fasten the implanted electrode arrangement CE to the nerve fascicle. The fastening is provided with the aid of a surgical thread, which is threaded at least once through each of the openings 14 and is sown in the tissue surrounding the nerve fascicle. In contrast to the region 1B of the carrier substrate rolled into a straight cylinder, to which the first and second electrode arrangements 2 and 7 are applied, such that they contact the surface of the epineurium of the nerve fascicle in the implanted state, the carrier substrate 1 adjoining the carrier substrate region 1B protrudes laterally from the nerve fascicle configured to be a flat lug and projects into the surrounding tissue. The metal ring structures 14 are intended to help mechanically reliably absorb the fastening forces acting along the surgical thread and to prevent damage to the carrier substrate caused by the thread cutting therein.

    [0052] The second electrode arrangement 7 should be arranged along the nerve fascicle on the side H leading to the heart in order to wind the implantable electrode arrangement CE in a cuff-like manner around a nerve fascicle (not illustrated in greater detail). The second electrode arrangement 2 serving for selective detection and also for selective stimulation of localized nerve fibers is attached along the nerve fascicle on the brain side G.

    [0053] The first and second electrode strips 5 and 8 and also the first and second electrode surfaces 4 and 9 are preferably applied to the carrier substrate by vapour deposition or sputtering but a galvanic reinforcement is conceivable. Laser structuring of thin metal foil is also a possible technique. For a permanent joining in particular of the first and second electrode strips 5 and 8, to the carrier substrate 1, the electrode strips have local openings 15 shown in FIG. 3a, through which the polymer material of the carrier substrate 1 passes or projects at least in part. The electrode surface 16 of the first and second electrode strips 5 and 8 are in each case for the remainder arranged flush with the carrier substrate upper side 1′ and directly contact the surface of the nerve fascicle.

    [0054] In order to permanently improve the joining of the electrode strips 5 and 8, it is proposed in a preferred exemplary embodiment to integrate the electrode strips largely into the carrier substrate in the following way as shown in FIG. 3b.

    [0055] The electrode strips 5 and 8 in each case have a metal base plate 17, having an upper side 18 and a lower side 19. Orthogonally raised structural elements 20 are provided integrally with the upper side 18 of the base plate 17, which are distributed in a planer over the surface of the upper side 18. Preferably the raised structural elements 20 are distributed over the entire surface of the upper side, preferably in the form of a pillar, rib, web, or sleeve extensions, which have a surface region 21 facing the carrier substrate surface 1′. The surface region can be in direct contact with the epineurium of the nerve fascicle. In addition, an adhesion promoting layer 22 is advantageously provided at least between the lower side 19 and the polymer material of the carrier substrate 1 surrounding the base plate 17. The adhesion promoting layer 22 can additionally also be applied to the upper side 18. Particularly suitable adhesion promoting layers are silicon carbide (SiC) and also diamond-like carbon (DLC). The electrode strips 5 and 8 are preferably manufactured from iridium oxide, which is a material having one of the highest charge transfer capacity.

    [0056] A further improved variant for forming the structural elements 20, which are applied in a distributed manner to the upper side of the base plate 17, is illustrated in FIG. 3c. FIG. 3c shows the longitudinal section through a structural element 20 which has a longitudinal extent LA oriented orthogonally to the upper side 18 of the metal base plate 17, along which the structural element 20 has at least one second surface region 23, which is oriented parallel to the upper side 18 of the metal base plate 17 and to which the adhesion promoting layer 22 or an adhesion promoting layer arrangement 22′ is applied. The second surface region 23 is fully surrounded by the biocompatible polymer in a manner arranged at a distance and separated from the first surface region 18 by the first adhesion promoting layer (22) or the adhesion promoting layer arrangement (22′). As can be inferred from FIG. 3c, the second surface region is oriented facing the upper side 18 of the base plate 17 and it is additionally possible and advantageous to provide the adhesion promoting layer 22 or the adhesion promoting layer arrangement 22′ both on a third surface region 24, which is opposite the second surface region 23, and/or on the upper side and/or lower side 18 and 19 of the base plate 17.

    [0057] The number and also arrangement of the individual structural elements 20 can be selected arbitrarily, but geometrically ordered in constellations KO, such as square, pentagonal, hexagonal or higher-value arrangement patterns, which are preferably suitable, as is understood from FIG. 3b.

    [0058] In a preferred arrangement of the base plate 3 within the carrier substrate 1, the base plate 17 is disposed centrally within the carrier substrate 1 that is the thickness of the biocompatible polymer layer bordering the lower side 19 of the base plate 17 should correspond approximately to the thickness of the polymer layer bordering the upper side 18 of the base plate 17. With this arrangement of the base plate 17, there is provided the advantage, which can be demonstrated by way of experiments, that the inherent metal stresses acting on the base plate 17 and which form during a tempering process are compensated. The tempering process is necessary in order to impress a material bias into the carrier substrate, by which the implantable cuff electrode can wind autonomously around the nerve fascicle.

    [0059] FIG. 4a to f illustrate a cuff M which partially surrounds the carrier substrate 1 of the implantable cuff electrode CE and which surrounds the region of the carrier substrate 1, both on the lower side and also upper side thereof, that directly adjoins the carrier substrate region 1B and, in contrast to the carrier substrate region 1B, does not deform independently in a straight cylinder-shaped manner by way of inherent material mechanical bias and in this way is made to be flush against the epineurium of the nerve fascicle in the implanted state.

    [0060] The cuff M primarily serves to provide improved handling of the implantable cuff electrode CE, which on account of its very small carrier substrate thickness and also the filigree electrode arrangements applied to the carrier substrate surface, requires particularly careful handling on the part of the surgeon. The cuff M is preferably formed in one part and has a cuff lower part Mu and a cuff upper part Mo, which are both connected in a hinged manner via a living hinge joint 25 as shown as FIGS. 4b and 4c. The cuff lower part Mu has an indentation 26 in which the carrier substrate 1 is embedded and into which the carrier substrate 1 can be inserted. In the inserted state, the cuff lower part Mu comprises the carrier substrate 1 in the framing manner deducible from FIG. 4b, that is the cuff lower part Mu protrudes laterally beneath the carrier substrate 1.

    [0061] The cuff upper part Mo connected integrally to the cuff lower part Mu via the hinge joint 25 is adapted in terms of shape and size to the cuff lower part Mu and, similarly to the cuff lower part Mu, which has an indentation 27 in which the carrier substrate 1 is embedded, so that in the closed state the cuff M encases the carrier substrate 1 hermetically in the manner illustrated in FIG. 4a, wherein merely the carrier substrate region 1B protrudes from the cuff M.

    [0062] In addition to improved handling, the cuff M in particular also serves to provides an improved fixing of the cuff electrode CE relative to the nerve fascicle. For this purpose, the cuff upper and lower sides Mo, Mu in each case provide fastening openings 14′ as shown in FIGS. 4a, b and d, which, when the cuff M is folded together, are aligned with the fastening openings 14 formed within the carrier substrate 1. In this way, it is possible to guide a surgical thread 28 through the openings 14 and 14′ in the cuff electrode CE surrounded by the cuff M. The fastening opening 14 of the cuff electrode CE, which is surrounded by a metal ring, can thus be relieved by the fastening opening 14′ formed within the cuff M. The cuff M is preferably manufactured from a stable plastic material, which for example may be parylene. In order to further increase the strength, Mo and Mu can also be a polymer hybrid (for example parylene (internally) and silicone rubber (externally)). This hybrid has the advantage that the stability of parylene is combined with the tear resistance of the silicone. In a preferred embodiment, the fastening openings 14′ within the cuff M are reinforced by an appropriate material thickening.

    [0063] Opening windows 29, which ensure free access to the reference electrode surfaces 12, are formed in the cuff upper part Mo. FIG. 4e is a cross-section through the carrier substrate 1. The carrier is comprised by the cuff M on the upper side of reference electrode surfaces 12. The electrode surfaces remain freely accessible through the opening windows 29 formed within the cuff upper part Mo. The opening windows 29 preferably comprise the reference electrode surfaces 12 with a limiting flank 29′ falling away in a sloped manner, which ensures that the reference electrode surfaces 29 can come into body contact with surrounding tissue over the entire surface.

    [0064] In order to ensure that the cuff M remains in a closed state, locking structures V are arranged between the cuff upper part and lower part Mo, Mu and for example are a pin 30 and indentation 31 arranged oppositely as shown in FIGS. 4c and f. When the cuff upper part and lower part are folded together, the pins 30 engage in the corresponding indentation 31 in a manner acted on by a force, which ensures that the pins 31 are held in place permanently in each case in a frictionally engaged manner. The closed state of a locking structure V is illustrated in FIG. 4f. Here, the pin 30, which is attached to the cuff upper part Mo, protrudes through a corresponding opening formed in the carrier substrate 1 and leads at the end into the indentation 31 of the cuff lower part Mu. Of course, alternative embodiments for the locking structures are conceivable, which for example may be in the form of suitably embodied latching mechanisms.

    [0065] FIG. 5 illustrates a further embodiment which enables a facilitated implantation of the cuff electrode CE formed in accordance with the invention. A fluid channel system 32 is formed within the carrier substrate 1 and is comprised fully by the carrier substrate 1. The fluid channel system 32 extends substantially in the region of the carrier substrate region 1B, which, on account of a material-inherent bias, assumes the form of a straight cylinder by way of an autonomous self-rolling, without the application of external force. If, by contrast, the fluid channel system 32 is filled with a fluid, which is preferably water, the water pressure forming along the fluid channel system 32 can thus cause the carrier substrate region 1b to spread out in a planar manner, against the material-inherent rolling forces. For this purpose, the fluid channel system 32 has fluid channel branches 33, which run in the circumferential direction of the lateral surface of the autonomously-forming straight cylinder and which, in the filled state, force the necessary extension of the carrier substrate region 1B.

    [0066] In order to fill the fluid channel system 32, at least two channel openings 34 are provided within the carrier substrate 1. The size and arrangement of the openings are such that they open out in a fluid-tight manner at entry and exit openings of fluid feed and discharge lines 35 and 36 running within the cuff M. The feed and discharge lines 35 and 36 running within the cuff M and are fluidically connected to a fluid control system 37, which can be actuated by a surgeon.

    [0067] In the case of an implantation, the fluid channel system 32 is filled with a fluid, whereby the carrier substrate region 1B is stretched out. In this state, the surgeon places the cuff electrode CE in a precise manner at a predefined point along the nerve fascicle. The fluid channel system 32 is then emptied by the surgeon, whereby the carrier substrate region 1B autonomously winds around the nerve fascicle. As a last step, the cuff electrode CE is fixed using a surgical thread to the surrounding tissue by the fastening openings 14′ provided in the cuff.

    [0068] In an advantageous embodiment of the above fluid channel system 32, it is possible to fill the fluid channel system with a shape-memory metal and shape-memory polymer. For the purpose of activation, the channel openings 34 are provided with metallized contacts, via which an electrical voltage can be applied along the feed lines 35 and 36 in order to unfold the implantable electrode arrangement CE via an accordingly modified control apparatus 37, until the electrode is ultimately placed in position.

    REFERENCE LIST

    [0069] 1 carrier substrate [0070] 1′ carrier substrate surface [0071] 1B carrier substrate region [0072] 2 first electrode arrangement [0073] 3 first electrode structures [0074] 4 first electrode surfaces [0075] 4a axial extent of the first electrode surfaces [0076] 4U extent of the first electrode surfaces oriented in the circumferential direction [0077] 5 first electrode strips [0078] 6, 6′ signal detector and generator [0079] 7 second electrode arrangement [0080] 8 second electrode strips [0081] 9 second electrode surfaces [0082] 9a axial extent of the second electrode surfaces [0083] 9U extent of the second electrode surfaces oriented in the circumferential direction [0084] 10 light wave conductor arrangement [0085] 11 light wave conductor openings [0086] 12 reference electrode surfaces, ECG electrode surfaces [0087] 13 second electrode structure [0088] 14 fastening openings [0089] 14′ fastening opening [0090] 15 opening [0091] 16 electrode strip surface [0092] 17 base plate [0093] 18 upper side [0094] 19 lower side [0095] 20 structural element [0096] 21 surface region [0097] 22 adhesion promoting layer [0098] 22′ adhesion promoting layer arrangement [0099] 23 second surface region [0100] 24 third surface region [0101] 24 third surface region [0102] 25 living hinge joint [0103] 26 indentation [0104] 27 indentation [0105] 28 surgical thread [0106] 29 opening window [0107] 29′ delimitation flank [0108] 30 pin [0109] 31 indentation [0110] 32 fluid channel system [0111] 33 fluid channel branches [0112] 34 channel opening [0113] 35 feed line, within the cuff [0114] 36 discharge line, within the cuff [0115] 37 fluid control system [0116] CE cuff electrode [0117] L conductive track [0118] V connection structure [0119] U circumferential direction [0120] A axial direction [0121] M cuff [0122] Mo cuff upper part [0123] Mu cuff lower part [0124] NF nerve fiber [0125] NFB nerve fascicle [0126] G brain [0127] H heart [0128] LI light wave conductor [0129] LQ light source(s) [0130] LA longitudinal axis of the structural element [0131] KO geometric constellations [0132] V locking structure