HYBRID INTRACEREBRAL ELECTRODE
20220047203 · 2022-02-17
Inventors
Cpc classification
A61B5/37
HUMAN NECESSITIES
A61B5/4836
HUMAN NECESSITIES
A61B5/384
HUMAN NECESSITIES
A61B5/686
HUMAN NECESSITIES
International classification
A61B5/37
HUMAN NECESSITIES
Abstract
The invention relates to a hybrid intracerebral electrode comprising a narrow, elongated body intended to be implanted in the brain of a patient in order to carry out at least one multi-scale electroencephalographic exploration. Said hybrid intracerebral electrode comprises, in its active part, a plurality of first electrical contact elements forming stationary macro-contacts, and a plurality of second electrical contact elements forming movable micro-contacts. The hybrid intracerebral electrode is characterised by control means which are built into the electrode in a coupling tip integral with the body. The control means are designed to move the second electrical contact elements between a passive position in which same are retracted inside the body and an active position in which same protrude outside the body, and simultaneously to adjust the controlled projection length thereof with respect to the body of the electrode.
Claims
1. A hybrid intracerebral electrode comprising a body narrow and elongated along a longitudinal axis, intended to be implanted in the brain of a patient for performing at least one multi-scale electroencephalographic exploration, said electrode having a distal end and a proximal end, and an active part provided on the distal end side, said active part being provided with at least one first electrical contact element forming a fixed macro-contact, arranged on the surface of said body and used in particular for recording the activity of an area of the brain under study, and at least one second electrical contact element forming a mobile micro-contact, projecting outside said body over a controlled projection length, and used at least to record the activity of small cell groups or even of a single neuron in said area of the brain under study, said at least one first electrical contact element and said at least one second electrical contact element each being electrically connected to at least one recording device by a dedicated conductor wire, said electrode further comprising means for controlling the relative position of said at least one second electrical contact element relative to said body of the electrode, wherein said electrode comprises at a proximal end a coupling tip integral with said body and on which is mounted said control means for controlling the relative position of said at least one second electrical contact element so that they form an integral part of said electrode, and wherein said control means is arranged firstly to displace said at least one second electrical contact element between a passive position in which the at least one second electrical contact element is retracted inside said body and an active position in which the at least one second electrical contact element projects outside said body, and secondly to adjust the controlled projection length of said at least one second electrical contact element relative to said body of the electrode.
2. The electrode according to claim 1, wherein said control means comprises at least one driving member movable in rotation relative to said coupling tip around a rotation axis coincident with the longitudinal axis of said body, and a driven member coupled to said driving member so as to be displaced in reciprocating axial translation in the direction of rotation of said driving member, and wherein said driven member is integral with said at least one second electrical contact element so that the at least one second electrical contact element is movable in translation in the longitudinal axis of said body over a stroke at least equal to the controlled projection length of the at least one second electrical contact element.
3. The electrode according to claim 2, wherein said driving member takes the form of a thumbwheel which may be actuated manually, coupled in rotation with said coupling tip by a thread, and movable in translation relative to said coupling tip.
4. The electrode according to claim 3, wherein said driven member takes the form of a pusher actuated in one direction and in an opposite direction according to the direction of rotation of said driving member.
5. The electrode according to claim 2, wherein the said driving member takes the form of a thumbwheel which may be actuated manually, coupled in rotation with said coupling tip by a guide surface, and fixed in axial translation relative to said coupling tip.
6. The electrode according to claim 5, wherein said driven member takes the form of an adjusting screw guided axially in said coupling tip, coupled in translation with said driving member by a thread, and fixed in rotation relative to said driving member.
7. The electrode according to claim 1, wherein said control means comprises at least one driving member movable in reciprocating axial translation relative to said coupling tip along an axis parallel to or coincident with the longitudinal axis of said body, and a driven member coupled to said driving member so as to be displaced in reciprocating axial translation in the direction of displacement of said driving member, and wherein said driven member is integral with said at least one second electrical contact element so that the at least one second electrical contact element is movable in translation along the longitudinal axis of said body over a stroke at least equal to the controlled projection length of the at least one second electrical contact element.
8. The electrode according to claim 1, wherein said control means comprises stroke limiters arranged in order to control an axial displacement of a driven member over a stroke at least equal to the controlled projection length of said at least one second electrical contact element.
9. The electrode according to claim 8, wherein said stroke limiters comprise at least one axial slot extending over a length corresponding to said stroke and cooperating with at least one guide pin, said axial slot being provided in one of the parts of said driven member or of said coupling tip, and said guide pin being provided in the other part of said coupling tip or of said driven member.
10. The electrode according to claim 1, wherein said coupling tip comprises a central bore in which a driven member is guided in axial translation and wherein said central bore defines a reserve in which the conductor wire dedicated to said at least one first electrical contact element may accumulate in order to absorb the travel of said driven member.
11. The electrode according to claim 1, wherein said control means comprises means for locating the outlet position of said at least one second electrical contact element.
12. The electrode according to claim 11, wherein said locating means comprises a slider integral with said at least one second electrical contact element and arranged to slide axially in a guide bore of said coupling tip or of a driving member, said slider comprise a marking and said guide bore comprise at least one through-hole for displaying said marking.
13. The electrode according to claim 1, wherein said body comprises at least one outlet port provided in the active part of the electrode, through which said at least one second electrical contact element projects outside said body in the active position.
14. The electrode according to claim 13, wherein the active part of the electrode comprises a plurality of first electrical contact elements distributed along the body of the electrode and separated from one another by intermediate insulating elements, and wherein the said at least one second electrical contact element projects through the said at least one outlet port provided in the said active part in one of the said intermediate insulating elements and/or in one of the said first electrical contact elements.
15. The electrode according to claim 13, wherein said at least one outlet port is provided on the periphery of said body and wherein said at least one second electrical contact element projects radially outside said body relative to the longitudinal axis.
16. The electrode according to claim 15, wherein the active part of the electrode comprises at least two second electrical contact elements distributed radially around said body.
17. The electrode according to claim 13, wherein the said active part comprises a plurality of second electrical contact elements grouped at least by two to exit through a same outlet port.
18. The electrode according to claim 13, wherein said active part comprises a plurality of outlet ports distributed over at least two levels along the body of the electrode and wherein said control means is arranged to individually or simultaneously control the second electrical contact elements per level.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0024] The present invention and the advantages thereof will appear more clearly in the following description of a plurality of embodiments given for purposes of illustration only and not intended to limit the scope of the invention, with reference to the accompanying drawings, wherein:
[0025]
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DETAILED DESCRIPTION
[0039] In the embodiments shown, identical elements or parts bear the same reference numbers. Furthermore, the variants described for the different embodiments of the invention may be combined with one another.
[0040] With reference to
[0041] The first electrical contact elements 5 form “macro-contacts” or “macro-electrodes” as opposed to the second electrical contact elements 6 which form “micro-contacts” or “micro-electrodes” whose contact surface is infinitely small compared to that of the “macro-contacts”. For example only, the first electrical contact elements 5 may have a diameter of 800 μm and a length of 2 mm, whereas the second electrical contact elements 6 may have a transverse dimension of 20 μm. Thus, the surface area ratio between the “macro-contacts” and the “micro-contacts” may be very high and, for example, be approx. 16000.sup.e, without the values stated being limiting.
[0042] Each first electrical contact element 5 is made of electrically conductive materials, preferably permeable to magnetic radiation, such as, by way of non-limiting examples, titanium, titanium-nickel alloys, graphite carbon, cobalt-based alloys, tantalum, platinum, platinum-iridium alloys, non-ferrous alloys based on copper, nickel-zinc alloys, zamak and copper-beryllium alloys, or similar. The first electrical contact elements 5 may be formed by pads, patches, rings, or any other part equivalent in shape, each connected to one of the conductor wires 52. They may be assembled together and/or to said body 2 of the electrode 1 by layering, gluing, crimping, overmoulding, or any other suitable assembly method. In the embodiment shown, the first contact elements 5 are formed by conductive rings interposed with insulating rings in order to form the active part 4 of the electrode 1. The insulating rings advantageously form insulating intermediate elements 7, which may be made differently depending on the embodiment of said first contact elements 5. In variant embodiments (not shown), the first electrical contact elements 5 may be made by any other suitable manufacturing process, such as, for example, by physical deposition of metal under vacuum (PVD), by semiconductor technology (MEMS: Microelectromechanical systems), or any other equivalent process. In this case, the insulating intermediate elements 7 may be constituted directly by the body 2 of the electrode 1. The first electrical contact elements 5 are distributed along the body 2 of the electrode 1, and preferably in its active part 4. They may or may not be identical, and may or may not be spaced apart by a regular pitch, this pitch being determined particularly by the insulating intermediate elements 7. They may or may not also comprise a first electrical contact element 5 at the distal end of said body 2. The techniques for manufacturing these first contact elements 5 may correspond to those already used in known deep electrodes, or they may make use of new technologies.
[0043] Each second electrical contact element 6 is constituted by the end of at least one very fine conductor wire 62 made of electrically conductive materials, measuring approx. 20 μm, but not limited to this size. These materials are preferably also permeable to magnetic radiation, such as those listed above in terms of the first electrical contact elements 5, in order to be compatible with medical magnetic resonance imaging devices. Each second electrical contact element 6 is preferably constituted by the end of a conductor wire 62. Of course, it is possible to multiply the number of conductor wires 62, each then forming a second electrical contact element 6 by itself and each being connected to a terminal of the multi-contact connector 61. In the example shown, the second electrical contact elements 6 are arranged in groups of four, positioned side by side, and form a tetrode. This example is non-limiting and it is possible to group two, three or more than four conductor wires 62 to adapt the number and distribution of the second electrical contact elements 6 to the technical specifications of the electrode 1. The second electrical contact elements 6 arranged in the axial housing 9 of said body 2 are provided to project outside said body 2 at least radially relative to the longitudinal axis A. The term “radially” must be understood in contrast to the term “axially” but without necessarily implying an angle of 90° between the projecting part of the second electrical contact elements 6 and the longitudinal axis A of the body 2. For example,
[0044] The body 2 of the electrode 1 is constituted by a hollow tube which delimits said axial housing 9 and forms a protective sheath for the conductor wires 52, 62 of the first and second electrical contact elements 5, 6. In addition, each of the conductor wires 52 and/or 62 may be individually insulated. Preferably, it is made of a synthetic material providing it with both good mechanical strength and a certain flexibility, and is electrically insulating. Examples of preferable synthetic materials are polyamides, polyether block amides, polycarbonates, polyimides, polytetrafluoroethylenes, or similar. It may have a circular section, or any other section that is compatible with the intended applications. Its transverse dimension is preferably very small, in particular measuring less than one millimetre, for example approx. 800 μm.
[0045] The electrode 1 according to the invention further comprises control means 10 for moving the second electrical contact element or elements 6 simultaneously between a passive position PP in which they are retracted inside the body 2 (see
[0046] In the example shown in
[0047] In this example, the driving member 11 takes the form of a thumbwheel 110, preferably cylindrical, that has a sufficient diameter so that it can be manually actuated by the practitioner. For this purpose, the gripping surface of this thumbwheel 110 has reliefs 111 so that it may be grasped easier without any sliding. The driving member 11 is coupled in rotation with the body 2 of the electrode 1 that is fixed. For this purpose, a coupling tip 20 is fixed to the end of said body 2 corresponding to the proximal end of the electrode 1, in order to carry said thumbwheel 110. This coupling tip 20 is preferably cylindrical and has a diameter substantially equal to the diameter of the thumbwheel 110, a diameter substantially greater than that of said body 2 so that it may be grasped easier. This coupling tip 20 comprises a fingerprint 21, and preferably two diametrically opposite fingerprints 21, making it possible for it to be grasped without sliding in order for it to be held in a fixed position with one hand while the other hand rotates the driving member 11, in one direction or in the opposite direction, according to the arrows R1 and R2 symbolised on the thumbwheel 110. For example, rotating the driving member 11 firstly in the direction of the arrow R1 moves the driven member 12 back and retracts the second electrical contact elements 6 to the passive position PP, in accordance with the symbol represented on the thumbwheel 110. In addition, the rotation of the driving member 11 in the opposite direction according to the arrow R2 leads to advancing the driven member 12 and moving the second electrical contact elements 6 to the active position PA, in accordance with the symbol represented on the thumbwheel 110. Of course, the shape of the thumbwheel 110 and that of the coupling tip 20 may not have a cylindrical shape, and it is essential that this shape be ergonomic and easy to maintain and handle.
[0048] In the example shown in
[0049] Always in this example, the driven member 12 takes the form of an adjusting screw 120 precise to the nearest millimetre, making it possible to very precisely adjust the position of the second electrical contact elements 6 within the nervous tissue. The driven member 12 is, on the one hand, coupled to the driving member 11 by a threaded section 121 screwed into a tapped bore 114 of the driving member 11, coaxial with the longitudinal axis A. The driven member 12 is, on the other hand, guided in axial translation in the coupling tip 20 integral with said body 2. For this purpose, the coupling tip 20 comprises a smooth cylindrical central bore 24 extending in the longitudinal axis A, open, communicating with the tapped bore 114 of the driving member 11, and in which a guide section 122 of the driven member 12 is slidably mounted, by means of an O-ring 124 and a centring bead 125. The O-ring 124 also makes it possible to provide sealing between the body 2 of the electrode 1 and the driving member 11 via the adjusting screw 120.
[0050] The driven member 12 is fixed in rotation relative to the driving member 11 and locked in rotation relative to said body 2 by means of two diametrically opposed guide pins 25 passing through a corresponding port provided in the guide section 22 and in a plane perpendicular to the longitudinal axis A. The end of each guide pin 25 cooperates with an axial slot 123 provided in the outer face of the guide section 122 of the driven member 12. These axial slots 123 extend over a determined stroke C in order to form, with the guide pins 25, stroke limiters arranged to control the axial displacement of the driven member 12 over a stroke C corresponding at least to the maximum projection length L6 of the second electrical contact elements 6. Of course, any other means for locking the driven member 12 from rotating relative to the driving member 11 and to the body 2, as well as any other stroke-limiter may be suitable.
[0051] The central bore 24 provided in the coupling tip 20 is deeper than the length of the guide section 122 of the driven member 12, including its stroke C, for the purpose of creating a reserve 26 in which the conductor wires 52 of the first electrical contact elements 5 may accumulate freely to absorb said stroke C of the driven member 12 (see
[0052] The control means 10 also comprises a member 13 for locating the axial position of the driven member 12 and therefore the position of the second electrical contact elements 6. In the example shown in
[0053] The component parts of the control means 10 are traversed by an axial housing 14 coinciding with the longitudinal axis A, coaxial with said axial housing 9 provided in the body 2, to make it possible for the conductor wires 52 and 62 to electrically connect the first electrical contact elements 5 and the second electrical contact elements 6 to a connected medical device. In order to make the free axial displacement of the conductor wires possible 52, 62 simultaneously with the driven member 12, the corresponding multi-wire sheaths 50, 60 are connected to the different moving parts 12 and 130 by means, for example, of plugs 15 arranged to close the corresponding axial bore 14 by sealing said sheaths. These plugs 15 may be formed by glue joints, inserts, or similar. Starting from the multi-contact connectors 51, 61, a first plug 15a closes the inlet of the axial housing 14a provided in the slider 130, and a second plug 15b closes the inlet of the axial housing 14b provided in the adjusting screw 120. Then, the multi-wire sheaths 50, 60 stop. The conductor wires 62 of the second electrical contact elements 6 are then secured to a guide tube 16 via a gluing area 17, itself firmly secured to the adjusting screw 120 by a third plug 15c closing the outlet of the axial housing 14b. This advantage of this guide tube 16 is that it accompanies and guides the conductor wires 62 of the second electrical contact elements 6 in their translational movement. The conductor wires 52 of the first electrical contact elements 5 are secured to the adjusting screw 120 by the third plug 15c closing the outlet of the axial housing 14b. Finally, the coupling tip 20 and the body 2 of the electrode 1 are secured by a fourth plug 15d closing the outlet of the axial bore 14d provided in the coupling tip 20. This embodiment is non-limiting, and any other equivalent means for connecting the sheaths 50, 60 to the parts 12, 13 may be used.
[0054] The control means 10 which has just been described with reference to
[0055] In another variant embodiment, shown in
[0056] With reference to
[0057] The various constituent parts of the electrode 1 may be manufactured by industrial processes and be made of materials compatible depending on the mechanical, electrical and magnetic stresses, in accordance with what is currently performed in terms of existing intracranial electrodes and/or according to different processes but compatible with this application.
[0058] The protocol for implanting deep intracerebral electrodes for performing stereoelectroencephalography (SEEG) has the advantage of not requiring modifications when standard deep electrodes are replaced by hybrid deep electrodes (macro-contacts and micro-contacts) according to the invention. In fact, electrode 1 is implanted in the brain of a patient, the second electrical contact elements 6 having returned to the passive position PA. Plug 3 makes it possible for the electrode 1 implanted on a screw or similar, previously anchored in the patient's skull to be maintained in position and sealed. The multi-contact connectors 51 and 61 are connected to a medical device. The practitioner, generally a neurosurgeon, may then actuate the control means 10 to move the second electrical contact elements 6 into the active position PA, and to adjust the controlled projection length L6 of these second electrical contact elements 6 throughout the implantation of the electrode 1.
[0059] This new electrode 1 has the advantage of being able to be used as a standard deep electrode, while making much higher quality and precise exploration and processing possible. Thus, it is clear from this description that the electrode 1 according to the invention meets the objectives set and provides substantial advantages over the hybrid electrodes of the prior art.
[0060] This invention is not limited to the examples embodiment described herein, but encompasses all amendments and alternatives that are clear to a person skilled in the art. In particular, the number of first electrical contact elements 5 as well as the number of second electrical contact elements 6, the number of conductor wires grouped to form each second electrical contact element 6, the pitch between the first electrical contact elements 5, the positioning and orientation of the second electrical contact elements 6 relative to these first electrical contact elements 5, etc. are variable parameters depending on the technical specifications of the electrode 1.