IMPLANTABLE ELECTRODE ARRANGEMENT
20170319846 · 2017-11-09
Inventors
- Dennis Plachta (Voerstetten, DE)
- Mortimer GIEHRTMUEHLEN (Freiburg, DE)
- Thomas Stieglitz (Freiburg, DE)
- Josef ZENTNER (Freiburg, DE)
Cpc classification
A61B2562/164
HUMAN NECESSITIES
A61B5/24
HUMAN NECESSITIES
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]
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
DETAILED DESCRIPTION OF THE INVENTION
[0044]
[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
[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
[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
[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
[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
[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]
[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
[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
[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
[0063] Opening windows 29, which ensure free access to the reference electrode surfaces 12, are formed in the cuff upper part Mo.
[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
[0065]
[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