WO1993004734A1 - Epidural electrode system intended to be introduced in the epidural space - Google Patents
Epidural electrode system intended to be introduced in the epidural space Download PDFInfo
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- WO1993004734A1 WO1993004734A1 PCT/FR1991/000719 FR9100719W WO9304734A1 WO 1993004734 A1 WO1993004734 A1 WO 1993004734A1 FR 9100719 W FR9100719 W FR 9100719W WO 9304734 A1 WO9304734 A1 WO 9304734A1
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- electrode system
- epidural
- support
- conductive
- epidural electrode
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- 230000005540 biological transmission Effects 0.000 claims abstract description 5
- 239000011810 insulating material Substances 0.000 claims description 5
- 238000009413 insulation Methods 0.000 claims description 3
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 2
- 229910052799 carbon Inorganic materials 0.000 claims description 2
- 239000002184 metal Substances 0.000 claims description 2
- 150000001768 cations Chemical class 0.000 claims 1
- 230000000638 stimulation Effects 0.000 description 12
- 210000001951 dura mater Anatomy 0.000 description 7
- 230000005284 excitation Effects 0.000 description 4
- 210000000278 spinal cord Anatomy 0.000 description 4
- 238000006073 displacement reaction Methods 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- 230000006439 vascular pathology Effects 0.000 description 3
- 230000002146 bilateral effect Effects 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 229920002635 polyurethane Polymers 0.000 description 2
- 239000004814 polyurethane Substances 0.000 description 2
- 229920000260 silastic Polymers 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 241001269524 Dura Species 0.000 description 1
- 239000004809 Teflon Substances 0.000 description 1
- 229920006362 Teflon® Polymers 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 230000001663 anti-spastic effect Effects 0.000 description 1
- 210000001175 cerebrospinal fluid Anatomy 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
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- 238000000034 method Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0551—Spinal or peripheral nerve electrodes
- A61N1/0558—Anchoring or fixation means therefor
Definitions
- the invention relates to an epidural electrode system intended to be introduced into the epidural space, with a view either to collecting or transmitting an electrical signal.
- This electrode system is applicable to all areas of posterior epidural neurostimulation, including vascular pathology.
- variable level which may become lower than the threshold of spinal excitation in certain positions of the body, - an absence of bilaterality and symmetry of stimulation, in particular in vascular pathology.
- the present invention aims to overcome all of the aforementioned drawbacks and has as main objective to provide an epidural electrode system guaranteeing, whatever the position of the body, a stable positioning of the electrode in the epidural space, and a stimulation greater than the threshold of spinal excitation.
- Another object of the invention is to provide an epidural electrode system making it possible to obtain bilateral and symmetrical stimulation.
- the invention relates to an epidural electrode system which is to be introduced into the epidural space with a view to either collecting or transmitting an electrical signal, characterized in that it comprises:
- a radially elastic support comprising an equatorial region and two spindle-shaped regions, called distal and proximal, extending on either side of said equatorial region, and secured respectively at the proximal and distal ends of the support,
- At least one active conductive zone situated in the equatorial region of the elastic support, and arranged to undergo the same radial deformations as said support,
- This electrode system therefore comprises an elastic support secured to its proximal and distal ends, capable of dynamic behavior in space allowing it to be applied anteriorly and posteriorly to the two sheets of the dura mater delimiting the space. epidural, regardless of the position of the body. Therefore, the electrode is autostatic and is positioned stably in the epidural space, without risk of displacement longitudinal, even when the patient is standing.
- the active area of the electrode forming an integral part of this support is permanently applied to the dura mater, and is at a minimum distance from the spinal cord whatever body position. Since the applied electrical charge is inversely proportional to the distance between the electrode and the spinal cord, minimizing this distance makes it possible to obtain, in all circumstances, stimulation greater than the threshold of spinal excitation.
- only the equatorial region of the elastic support has an active zone which is applied permanently against the dura mater, and, through it, against the cerebrospinal fluid, so that the variations geometric of the epidural space do not cause any variation in the active conductive surface and the impedance of the electrode / cellulo-fatty tissue system.
- the elastic support comprises an active area in the equatorial region, an active area in the distal region and an active area in the proximal region.
- the active surface of the elastic support applying against the dura is inversely proportional to the dimensions of the epidural space. Consequently, the electrical density is proportional to the dimensions of this epidural space. Knowing that the impedance of the electrode / cellulo-fatty tissue system is also inversely proportional to the active surface of the electrode and that consequently any reduction in this space results in an increase in the intensity delivered, this characteristic makes it possible to compensate for this increase intensity thanks to the increase in the active surface applied to the dura mater and therefore to obtain stimulation at a substantially constant level.
- the elastic support consists of at least two arch-shaped arches secured towards their ends, and distributed around the axis of said support.
- each of these arches preferably consists of a conductive strand sheathed with an insulating material, each of said strands being stripped over a length at least equivalent to the equatorial region.
- the conductive link consists of a conductive cable secured to the end of the proximal spindle, and comprising a so-called proximal end provided with an electrical connection plug comprising a number of contacts equivalent to the number of arches.
- the conductive cable comprises a number of conductive strands at least equivalent to the number of arches, and each of said arches is formed by the extension of one of said conductive strands secured to each other at the ends. proximal and distal of the support.
- the conductive cable comprises a general insulation sheath of the conductive strands, said sheath, interrupted at the proximal end of the support, being adapted to secure the strands at said end. .
- this epidural electrode system advantageously comprises a device for introducing and removing the elastic support in the epidural space, consisting of a sheath of internal diameter adapted to accommodate said support in a radially folded state.
- the sheath which encloses the electrode in its fully folded configuration, for the implantation thereof, allows this electrode to be released at the location of the chosen stimulation site, by a simple retraction of this sheath along the conductor cable.
- the sheath can be left in place so as to allow the withdrawal of the electrode and the possible reintroduction of another electrode.
- the tapered shape of the proximal and distal regions of the elastic support is particularly suitable for allowing this support to penetrate inside the sheath.
- FIG. 1 is a perspective view with a partial cutaway of an epidural electrode system according to the invention
- FIG. 2 is a cross section on an enlarged scale of the conductive cable of this system
- FIG. 3 is a perspective view, on an enlarged scale, of the electrode of this system
- FIG. 4 is a schematic section representing the electrode system implanted in the epidural space, in the lying position of a patient,
- FIG. 5 is a diagrammatic cross-section through a plane A in FIG. 3,
- FIG. 6 is a diagrammatic section representing the electrode system implanted in the epidural space, in the standing position of a patient,
- FIG. 7 is a schematic cross section through a plane B in FIG. 5,
- FIG. 8 is a schematic perspective view of an alternative embodiment of an epidural electrode system according to the invention, shown without its introduction sheath.
- the electrode systems represented in FIGS. 1, 2, 3 and 7 are intended to be introduced into the epidural space, for the purpose of either transmitting or collect an electrical signal. These systems apply, in particular, to percutaneous epidural stimulation electrodes, applicable to all areas of posterior epidural neurostimulation, in particular to vascular pathology.
- the epidural electrode system represented in FIGS. 1, 2 and 3 comprises three elements: a conductive cable 1 for connection with electrical transmission means such as a pulse generator (not shown), an electrode head 2, and an introduction sheath 3-
- the conductive cable 1 with a diameter of 1 mm, consists of four twisted strands 4, as shown in FIG. 2, or of eight twisted strands, and a sheath 7 of general insulation of said strands strands.
- These strands 4, made of reinforced carbon, stainless steel ... have a diameter of 0.3 mm, and are coated with an insulator 5 such as polyurethane, high performance silastic ...
- These conductive strands 4 are armed with a metallic wire 6 embedded in the mass which provides the rigidity and possibly the radio-opacity necessary for the percutaneous introduction of the electrode under image intensifier, and for its subsequent radiological monitoring.
- the proximal end of the conductive cable 1 is provided with an electrical connection plug 9 comprising four electrical contacts, for the connection of this cable to electrical transmission means.
- the electrode head 2 is constituted by the extension of the four strands 4 of the conductive cable 1, shaped so as to form four arches 8 in the form of a hanger distributed regularly around the axis of this cable.
- the electrode head 2 therefore comprises two anterior arches and two posterior arches, each of these arches comprising an equatorial section 8a, and two sections, distal 8b and proximal 8c, extending on either side of the equatorial section.
- the distal sections 8b of these four arches 8 have a curved shape and are welded at their ends. These sections are sheathed with an insulating material and form the essentially elastic distal region, spindle-shaped, with a developed length substantially between 1 mm and 2.5 mm, from the electrode head 2.
- the middle sections 8a of the four arches 8 constitute the active part of the electrode head. These sections are stripped and form the equatorial region with a developed length substantially between 1.5 mm and 2.5 mm from the electrode head 2.
- proximal sections 8c of the arches 8 have a symmetrical curved shape of the distal sections 8b and are secured at their end by the sheath 7. These sections are sheathed with an insulating material and form the proximal region, spindle-shaped , of a length substantially between 1 mm and 2.5 mm, from the electrode head 2.
- This electrode head 2 therefore has a conductive active surface located in its equatorial region having a substantially cylindrical shape with a height of the order of 2 mm.
- This active surface has an area of approximately 1.89 mm 2 , ie a total area for the electrode head of 7.56 mm 2 .
- the main feature of this electrode head 2 is to have a radial elasticity allowing it to be applied, at least by its active surface, anteriorly and posteriorly on the dura mater, whatever or the position of the body.
- this electrode head 2 thus has a diameter of the order of 2.5 mm in its folded shape corresponding to a lying position of the patient, and a diameter of the order of 4 to 4.5 mm in its deployed position corresponding to the standing position of this patient.
- this electrode head 2 comprises four arches 8 each provided with an active surface, makes it possible to systematically position the latter so that two arches 8 are applied to the internal sheet of the dura mater symmetrically on either side of the spinal cord.
- This electrode head 2 makes it possible to obtain symmetrical and bilateral stimulation.
- the epidural electrode system finally comprises a sheath for introducing the electrode head 2 into the epidural space.
- This sheath 3 made of a material such as teflon, polyurethane, silastic, etc., has an internal diameter slightly greater than the diameter of the conductive cable 1.
- This sheath 3 has, in addition, a slightly tapered end allowing it to be introduced optionally onto a thin metal guide, itself passed through a conventional "TUOHY" needle.
- the conductive cable 1 will include a hollow core making it possible to introduce the electrode 2 / sheath 3 assembly coaxially onto the guide.
- This sheath 3 intended to accommodate the conductive cable 1 and the electrode head 2, in the fully folded configuration thereof, makes it possible to implant this electrode head 2 at the location of the chosen stimulation site.
- the electrode head 2 is released by a simple retraction of the sheath 3 along the conductive cable 1, and deploys radially, under the effect of its elasticity, so as to come to be applied at least by its active surface on the two sheets of the dura mater.
- the sheath 3 can be left in place so as to allow the withdrawal of the electrode head 2 and the possible introduction of another electrode head.
- the electrode head 2 described above is particularly suitable, by its dimensions, for being located at the level of the dorsolumbar stage D11-L1. However, it is evident that these dimensions can be modified in order to implant this electrode head at different levels of the posterior epidural space. Furthermore, the electrode head can also consist of six arches 8, - three anterior arches and three posterior arches, distributed regularly around the axis of the conductive cable 1. This particular configuration makes it possible to apply bi-polar stimulation paramedian, using the middle arch as an anode.
- FIG. 8 represents an alternative embodiment of an epidural electrode system according to the invention, comprising several electrode heads 2 spaced along a single conductive cable 1, and constituting a multifunctional multipolar electrode.
Abstract
The invention relates to an epidural electrode system intended to be introduced in the epidural space in order to receive and/or transmit an electric signal. Said epidural electrode is comprised of a radially elastic support (2) having an equatorial region (8a) and two bundle-shaped regions, called distal (8b) and proximal (8c) extending on either side of said equatorial region, at least one conducting active area situated in the equatorial region (8a) of said elastic support (2) and a conducting connection (1) between each of said active zones and electric transmission means.
Description
SYSTEME D'ELECTRODE EPIDURALE APPELEE A ETRE INTRODUITE DANS L'ESPACE EPIDURAL EPIDURAL ELECTRODE SYSTEM CALLED TO BE INTRODUCED IN THE EPIDURAL SPACE
L'invention concerne un système d'électrode épidurale appelée à être introduite dans l'espace epidural, en vue soit de recueillir, soit de transmettre un signal électrique.The invention relates to an epidural electrode system intended to be introduced into the epidural space, with a view either to collecting or transmitting an electrical signal.
Ce système d'électrode est applicable à tous les domaines de la neurostimulation épidurale postérieure, notamment à la pathologie vasculaire.This electrode system is applicable to all areas of posterior epidural neurostimulation, including vascular pathology.
Les effets analgésiques et antispastiques de la neurostimulation épidurale postérieure sont exploités en thérapeutique depuis une vingtaine d'années. Toutefois, à l'heure actuelle, cette technique thérapeutique n'est pas encore totalement maîtrisée en raison des spécificités géométriques de la zone d'implantation de l'électrode, à savoir l'espace epidural, dont la largeur varie selon que le patient est en position couchée, de procubitus, ou debout. Avec les électrodes conventionnelles, ces variations de la largeur de la zone d'implantation de ces électrodes conduisent, en effet, à des échecs résultant notamment :The analgesic and antispastic effects of posterior epidural neurostimulation have been used therapeutically for about twenty years. However, at present, this therapeutic technique is not yet fully mastered due to the geometrical specificities of the implantation zone of the electrode, namely the epidural space, the width of which varies according to whether the patient is lying down, prone, or standing. With conventional electrodes, these variations in the width of the implantation area of these electrodes lead, in fact, to failures resulting in particular:
- du déplacement longitudinal de l'électrode à l'intérieur de l'espace epidural, - de la fracture de cette électrode soumise à des contraintes de compression,- the longitudinal displacement of the electrode inside the epidural space, - the fracture of this electrode subjected to compression stresses,
- d'une stimulation de niveau variable, pouvant devenir inférieure au seuil d'excitation médullaire dans certaines positions du corps, - d'une absence de bilatéralité et de symétrie de la stimulation, notamment en pathologie vasculaire.- stimulation of a variable level, which may become lower than the threshold of spinal excitation in certain positions of the body, - an absence of bilaterality and symmetry of stimulation, in particular in vascular pathology.
En l'absence d'électrodes spécifiques permettant de solutionner ces inconvénients, les praticiens se trouvent donc obligés d'accepter un pourcentage d'échecs lors de l'application de ce traitement de neurostimulation épidurale.In the absence of specific electrodes enabling these drawbacks to be resolved, practitioners are therefore forced to accept a percentage of failures when applying this epidural neurostimulation treatment.
Pour tenter de pallier ces inconvénients, une solution a consisté à réaliser une électrode décrite dans le brevet européen EP 23.410, comportant un système de
stabilisation par ailettes dont l'ouverture est commandée par un mandrin central. Un tel système permet, en effet, de minimiser les risques de déplacement longitudinal. Toutefois, il n'assure pas l'obtention d'une stimulation systématiquement supérieure au seuil d'excitation médullaire car la zone active de l'électrode est fixe dans l'espace et peut donc se trouver plus ou moins éloignée de la moelle épinière.In an attempt to overcome these drawbacks, one solution consisted in producing an electrode described in European patent EP 23,410, comprising a system of stabilization by fins, the opening of which is controlled by a central mandrel. Such a system makes it possible, in fact, to minimize the risks of longitudinal displacement. However, it does not ensure that stimulation is systematically higher than the spinal excitation threshold because the active area of the electrode is fixed in space and can therefore be more or less distant from the spinal cord.
La présente invention vise à pallier l'ensemble des inconvénients précités et a pour principal objectif de fournir un système d'électrode épidurale garantissant, quelle que soit la position du corps, un positionnement stable de l'électrode dans l'espace epidural, et une stimulation supérieure au seuil d'excitation médullaire.The present invention aims to overcome all of the aforementioned drawbacks and has as main objective to provide an epidural electrode system guaranteeing, whatever the position of the body, a stable positioning of the electrode in the epidural space, and a stimulation greater than the threshold of spinal excitation.
Un autre objectif de l'invention est de fournir un système d'électrode épidurale permettant d'obtenir une stimulation bilatérale et symétrique.Another object of the invention is to provide an epidural electrode system making it possible to obtain bilateral and symmetrical stimulation.
A cet effet, l'invention vise un système d'électrode épidurale appelée à être introduite dans l'espace epidural en vue, soit de recueillir, soit de transmettre un signal électrique, caractérisé en ce qu'il comprend :To this end, the invention relates to an epidural electrode system which is to be introduced into the epidural space with a view to either collecting or transmitting an electrical signal, characterized in that it comprises:
- un support radialement élastique comportant une région équatoriale et deux régions en forme de fuseau, dites distale et proximale, s'étendant de part et d'autre de ladite région équatoriale, et solidarisées respectivement au niveau des extrémités proximale et distale du support,a radially elastic support comprising an equatorial region and two spindle-shaped regions, called distal and proximal, extending on either side of said equatorial region, and secured respectively at the proximal and distal ends of the support,
- au moins une zone active conductrice située dans la région équatoriale du support élastique, et agencée pour subir les mêmes déformations radiales que ledit support,at least one active conductive zone situated in the equatorial region of the elastic support, and arranged to undergo the same radial deformations as said support,
- et une liaison conductrice entre des moyens de transmission électrique et chaque zone active.- And a conductive link between electrical transmission means and each active area.
Ce système d'électrode comporte donc un support élastique solidarisé vers ses extrémités proximale et distale, capable d'un comportement dynamique dans l'espace lui permettant de s'appliquer antérieurement et postérieurement sur les deux feuillets de la dure-mère délimitant l'espace epidural, quelle que soit la position du corps. De ce fait, l'électrode est autostatique et se trouve positionnée de façon stable dans l'espace epidural, sans risque de déplacement
longitudinal, et ce même lors de stations debout du patient.This electrode system therefore comprises an elastic support secured to its proximal and distal ends, capable of dynamic behavior in space allowing it to be applied anteriorly and posteriorly to the two sheets of the dura mater delimiting the space. epidural, regardless of the position of the body. Therefore, the electrode is autostatic and is positioned stably in the epidural space, without risk of displacement longitudinal, even when the patient is standing.
De plus, grâce à ce comportement dynamique du support élastique, la zone active de l'électrode faisant partie intégrante de ce support s'applique en permanence sur la dure-mère, et se trouve à une distance minimale de la moelle épinière quelle que soit la position du corps. La charge électrique appliquée étant inversement proportionnelle à la distance entre électrode et moelle épinière, le fait de minimiser cette distance permet d'obtenir, en toutes circonstances, une stimulation supérieure au seuil d'excitation médullaire.In addition, thanks to this dynamic behavior of the elastic support, the active area of the electrode forming an integral part of this support is permanently applied to the dura mater, and is at a minimum distance from the spinal cord whatever body position. Since the applied electrical charge is inversely proportional to the distance between the electrode and the spinal cord, minimizing this distance makes it possible to obtain, in all circumstances, stimulation greater than the threshold of spinal excitation.
Selon un premier mode de réalisation, seule la région équatoriale du support élastique comporte une zone active qui vient s'appliquer en permanence contre la dure-mère, et, à travers elle, contre le liquide céphalo- rachidien, de telle sorte que les variations géométriques de l'espace epidural n'entrainent aucune variation de la surface active conductrice et de l'impédance du système électrode/tissu cellulo-graisseux.According to a first embodiment, only the equatorial region of the elastic support has an active zone which is applied permanently against the dura mater, and, through it, against the cerebrospinal fluid, so that the variations geometric of the epidural space do not cause any variation in the active conductive surface and the impedance of the electrode / cellulo-fatty tissue system.
Selon un deuxième mode de réalisation, le support élastique comporte une zone active dans la région équatoriale, une zone active dans la région distale et une zone active dans la région proximale. Dans ce cas, la surface active du support élastique s'appliquant contre la dure-mère est inversement proportionnelle aux dimensions de l'espace epidural. Par conséquent, la densité électrique est proportionnelle aux dimensions de cet espace epidural. Sachant que l'impédance du système électrode/tissu cellulo-graisseux est également inversement proportionnelle à la surface active de l'électrode et que par conséquent toute diminution de cet espace entraîne une augmentation de l'intensité délivrée, cette particularité permet de compenser cette augmentation d'intensité grâce à l'augmentation de la surface active appliquée sur la dure-mère et donc d'obtenir une stimulation à un niveau sensiblement constant.According to a second embodiment, the elastic support comprises an active area in the equatorial region, an active area in the distal region and an active area in the proximal region. In this case, the active surface of the elastic support applying against the dura is inversely proportional to the dimensions of the epidural space. Consequently, the electrical density is proportional to the dimensions of this epidural space. Knowing that the impedance of the electrode / cellulo-fatty tissue system is also inversely proportional to the active surface of the electrode and that consequently any reduction in this space results in an increase in the intensity delivered, this characteristic makes it possible to compensate for this increase intensity thanks to the increase in the active surface applied to the dura mater and therefore to obtain stimulation at a substantially constant level.
Selon une autre caractéristique de l'invention, le support élastique est constitué d'au moins
deux arches en forme de cintre solidarisées vers leurs extrémités, et réparties autour de l'axe dudit support.According to another characteristic of the invention, the elastic support consists of at least two arch-shaped arches secured towards their ends, and distributed around the axis of said support.
En outre, chacune de ces arches est preferentiellement constituée d'un brin conducteur gainé d'un matériau isolant, chacun desdits brins étant dénudé sur une longueur au moins équivalente à la région équatoriale.In addition, each of these arches preferably consists of a conductive strand sheathed with an insulating material, each of said strands being stripped over a length at least equivalent to the equatorial region.
Selon une autre caracté istique de l'invention, la liaison conductrice est constituée d'un câble conducteur solidaire de l'extrémité du fuseau proximal, et comprenant une extrémité dite proximale dotée d'une fiche de connexion électrique comportant un nombre de contacts équivalent au nombre d'arches.According to another characteristic of the invention, the conductive link consists of a conductive cable secured to the end of the proximal spindle, and comprising a so-called proximal end provided with an electrical connection plug comprising a number of contacts equivalent to the number of arches.
En outre, selon un mode de réalisation préféré, le câble conducteur comporte un nombre de brins conducteurs au moins équivalent au nombre d'arches, et chacune desdites arches est constituée par le prolongement d'un desdits brins conducteurs solidarisés entre eux au niveau des extrémités proximale et distale du support. Cette caractéristique additionnelle présente un intérêt notable en raison de la facilité de fabrication d'un tel système d'électrode dont le support élastique est réalisé d'un seul tenant avec le câble conducteur et constitue l'épanouissement terminal des brins conducteurs de ce câble. Selon une autre caractéristique de l'invention, le câble conducteur comprend une gaine d'isolation générale des brins conducteurs, ladite gaine, interrompue au niveau de l'extrémité proximale du support, étant adaptée pour assurer la solidarisation des brins au niveau de ladite extrémité.In addition, according to a preferred embodiment, the conductive cable comprises a number of conductive strands at least equivalent to the number of arches, and each of said arches is formed by the extension of one of said conductive strands secured to each other at the ends. proximal and distal of the support. This additional characteristic is of notable interest due to the ease of manufacture of such an electrode system, the elastic support of which is made in one piece with the conductive cable and constitutes the terminal development of the conductive strands of this cable. According to another characteristic of the invention, the conductive cable comprises a general insulation sheath of the conductive strands, said sheath, interrupted at the proximal end of the support, being adapted to secure the strands at said end. .
Par ailleurs, ce système d'électrode épidurale comprend avantageusement un dispositif d'introduction et de retrait du support élastique dans l'espace epidural, constitué d'un fourreau de diamètre interne adapté pour loger ledit support dans un état radialement replié.Furthermore, this epidural electrode system advantageously comprises a device for introducing and removing the elastic support in the epidural space, consisting of a sheath of internal diameter adapted to accommodate said support in a radially folded state.
Le fourreau qui renferme l'électrode dans sa configuration totalement repliée, en vue de l'implantation de celle-ci, permet de dégager cette électrode à l'endroit du site de stimulation choisi, par un simple recul de ce fourreau
le long du câble conducteur.The sheath which encloses the electrode in its fully folded configuration, for the implantation thereof, allows this electrode to be released at the location of the chosen stimulation site, by a simple retraction of this sheath along the conductor cable.
En outre, après mobilisation, le fourreau peut être laissé en place de façon à permettre le retrait de l'électrode et la réintroduction éventuelle d'une autre électrode.In addition, after mobilization, the sheath can be left in place so as to allow the withdrawal of the electrode and the possible reintroduction of another electrode.
Il est à noter, à cet effet, que la forme en fuseau des régions proximale et distale du support élastique est particulièrement adaptée pour permettre à ce support de pénétrer à l'intérieur du fourreau.It should be noted, for this purpose, that the tapered shape of the proximal and distal regions of the elastic support is particularly suitable for allowing this support to penetrate inside the sheath.
D'autres caractéristiques, buts et avantages de l'invention ressortiront de la description détaillée qui suit en référence aux dessins annexés, qui en représentent à titre d'exemples non limitatifs un mode de réalisation préférentiel et une variante de réalisation. Sur ces dessins qui font partie intégrante de la présente description :Other characteristics, objects and advantages of the invention will emerge from the detailed description which follows with reference to the appended drawings, which represent, by way of non-limiting examples, a preferred embodiment and an alternative embodiment. On these drawings which form an integral part of this description:
- la figure 1 est une vue en perspective avec un arraché partiel d'un système d'électrode épidurale conforme à l'invention, - la figure 2 est une coupe transversale à échelle agrandie du câble conducteur de ce système,- Figure 1 is a perspective view with a partial cutaway of an epidural electrode system according to the invention, - Figure 2 is a cross section on an enlarged scale of the conductive cable of this system,
- la figure 3 est une vue en perspective, à échelle agrandie, de l'électrode de ce système,FIG. 3 is a perspective view, on an enlarged scale, of the electrode of this system,
- la figure 4 est une coupe schématique représentant le système d'électrode implanté dans l'espace epidural, en position couchée d'un patient,FIG. 4 is a schematic section representing the electrode system implanted in the epidural space, in the lying position of a patient,
- la figure 5 est une coupe transversale schématique par un plan A de la figure 3,FIG. 5 is a diagrammatic cross-section through a plane A in FIG. 3,
- la figure 6 est une coupe schématique représentant le système d'électrode implanté dans l'espace epidural, en position debout d'un patient,FIG. 6 is a diagrammatic section representing the electrode system implanted in the epidural space, in the standing position of a patient,
- la figure 7 est une coupe transversale schématique par un plan B de la figure 5,FIG. 7 is a schematic cross section through a plane B in FIG. 5,
- la figure 8 est une vue en perspective schématique d'une variante de réalisation d'un système d'électrode epidural conforme à l'invention, représenté sans son fourreau d'introduction.- Figure 8 is a schematic perspective view of an alternative embodiment of an epidural electrode system according to the invention, shown without its introduction sheath.
Les systèmes d'électrodes représentés aux figures 1, 2, 3 et 7 sont destinés à être introduits dans l'espace epidural, en vue soit de transmettre, soit de
recueillir un signal électrique. Ces systèmes s'appliquent, en particulier, aux électrodes de stimulation épidurale percutanée, applicables à tous les domaines de la neurostimulation épidurale postérieure, notamment à la pathologie vasculaire.The electrode systems represented in FIGS. 1, 2, 3 and 7 are intended to be introduced into the epidural space, for the purpose of either transmitting or collect an electrical signal. These systems apply, in particular, to percutaneous epidural stimulation electrodes, applicable to all areas of posterior epidural neurostimulation, in particular to vascular pathology.
Le système d'électrode épidurale représenté aux figures 1, 2 et 3 comprend trois éléments : un câble conducteur 1 de liaison avec des moyens de transmission électrique tel qu'un générateur d'impulsions (non représenté), une tête d'électrode 2, et un fourreau d'introduction 3-The epidural electrode system represented in FIGS. 1, 2 and 3 comprises three elements: a conductive cable 1 for connection with electrical transmission means such as a pulse generator (not shown), an electrode head 2, and an introduction sheath 3-
En premier lieu, le câble conducteur 1, d'un diamètre de 1 mm, est constitué de quatre brins 4 torsadés, tel que représenté à la figure 2, ou de huit brins torsadés, et d'une gaine 7 d'isolation générale desdits brins.Firstly, the conductive cable 1, with a diameter of 1 mm, consists of four twisted strands 4, as shown in FIG. 2, or of eight twisted strands, and a sheath 7 of general insulation of said strands strands.
Ces brins 4, réalisés en carbone armé, en acier inoxydable... présentent un diamètre de 0,3 mm, et sont enrobés d'un isolant 5 tel que polyuréthane, silastic haute performance... Ces brins conducteurs 4 sont armés d'un fil métallique 6 noyé dans la masse qui assure la rigidité et éventuellement la radio-opacité nécessaires à l'introduction percutanée de l'électrode sous amplificateur de brillance, et à sa surveillance radiologique ultérieure. Enfin, l'extrémité proximale du câble conducteur 1 est dotée d'une fiche de connexion électrique 9 comportant quatre contacts électriques, pour le raccordement de ce câble à des moyens de transmission électrique.These strands 4, made of reinforced carbon, stainless steel ... have a diameter of 0.3 mm, and are coated with an insulator 5 such as polyurethane, high performance silastic ... These conductive strands 4 are armed with a metallic wire 6 embedded in the mass which provides the rigidity and possibly the radio-opacity necessary for the percutaneous introduction of the electrode under image intensifier, and for its subsequent radiological monitoring. Finally, the proximal end of the conductive cable 1 is provided with an electrical connection plug 9 comprising four electrical contacts, for the connection of this cable to electrical transmission means.
La tête d'électrode 2 est constituée par le prolongement des quatre brins 4 du câble conducteur 1, conformés de façon à former quatre arches 8 en forme de cintre réparties régulièrement autour de l'axe de ce câble.The electrode head 2 is constituted by the extension of the four strands 4 of the conductive cable 1, shaped so as to form four arches 8 in the form of a hanger distributed regularly around the axis of this cable.
Ces arches sont solidarisées entre elles par soudure au niveau de leur extrémité distale. Au niveau de l'extrémité proximale de la tête d'électrode 2, elles sont solidarisées au moyen de la gaine 7 d'isolation du câble conducteur 1 interrompue au droit de cette extrémité de support.These arches are joined together by welding at their distal end. At the proximal end of the electrode head 2, they are secured by means of the sheath 7 for insulating the conductive cable 1 interrupted at the right of this support end.
La tête d'électrode 2 comprend donc deux arches antérieures et deux arches postérieures, chacune de ces
arches comportant un tronçon equatorial 8a, et deux tronçons, distal 8b et proximal 8c, s'étendant de part et d'autre du tronçon equatorial. Les tronçons distaux 8b de ces quatre arches 8 présentent une forme cintrée et sont soudés au niveau de leur extrémité. Ces tronçons sont gainés d'un matériau isolant et forment la région distale essentiellement élastique, en forme de fuseau, d'une longueur développée sensiblement comprise entre 1 mm et 2,5 mm, de la tête d'électrode 2.The electrode head 2 therefore comprises two anterior arches and two posterior arches, each of these arches comprising an equatorial section 8a, and two sections, distal 8b and proximal 8c, extending on either side of the equatorial section. The distal sections 8b of these four arches 8 have a curved shape and are welded at their ends. These sections are sheathed with an insulating material and form the essentially elastic distal region, spindle-shaped, with a developed length substantially between 1 mm and 2.5 mm, from the electrode head 2.
Les tronçons médians 8a des quatre arches 8 constituent la partie active de la tête d'électrode. Ces tronçons sont dénudés et forment la région équatoriale d'une longueur développée sensiblement comprise entre 1,5 mm et 2,5 mm de la tête d'électrode 2.The middle sections 8a of the four arches 8 constitute the active part of the electrode head. These sections are stripped and form the equatorial region with a developed length substantially between 1.5 mm and 2.5 mm from the electrode head 2.
Enfin, les tronçons proximaux 8c des arches 8 présentent une forme cintrée symétrique des tronçons distaux 8b et sont solidarisés au niveau de leur extrémité par la gaine 7. Ces tronçons sont gainés d'un matériau isolant et forment la région proximale, en forme de fuseau, d'une longueur sensiblement comprise entre 1 mm et 2,5 mm, de la tête d'électrode 2.Finally, the proximal sections 8c of the arches 8 have a symmetrical curved shape of the distal sections 8b and are secured at their end by the sheath 7. These sections are sheathed with an insulating material and form the proximal region, spindle-shaped , of a length substantially between 1 mm and 2.5 mm, from the electrode head 2.
Cette tête d'électrode 2 comporte donc une surface active conductrice située dans sa région équatoriale présentant une forme sensiblement cylindrique d'une hauteur de l'ordre de 2 mm. Cette surface active présente une superficie de 1,89 mm2 environ, soit une superficie totale pour la tête d'électrode de 7,56 mm2. Tel que représenté aux figures 4 à 7, la particularité principale de cette tête d'électrode 2 est de présenter une élasticité radiale lui permettant de s'appliquer, au moins par sa surface active, antérieurement et postérieurement sur la dure-mère, quelle que soit la position du corps.This electrode head 2 therefore has a conductive active surface located in its equatorial region having a substantially cylindrical shape with a height of the order of 2 mm. This active surface has an area of approximately 1.89 mm 2 , ie a total area for the electrode head of 7.56 mm 2 . As shown in Figures 4 to 7, the main feature of this electrode head 2 is to have a radial elasticity allowing it to be applied, at least by its active surface, anteriorly and posteriorly on the dura mater, whatever or the position of the body.
Dans la pratique, cette tête d'électrode 2 présente ainsi un diamètre de l'ordre de 2,5 mm dans sa forme repliée correspondant à une position couchée du patient, et un diamètre de l'ordre de 4 à 4,5 mm dans sa position déployée correspondant à la position debout de ce patient.
En outre, le fait que cette t ête d'électrode 2 comporte quatre arches 8 dotées chacune d'une surface active, permet de positionner systématiquement cette dernière de façon que deux arches 8 viennent s'appliquer sur le feuillet interne de la dure-mère symétriquement de part et d'autre de la moelle épinière. De ce fait, cette tête d'électrode 2 permet d'obtenir une stimulation symétrique et bilatérale. Le système d'électrode épidurale comprend, enfin, un fourreau d'introduction de la tête d'électrode 2 dans l'espace epidural. Ce fourreau 3» réalisé en un matériau tel que du téflon, du polyuréthane, du silastic..., présente un diamètre interne légèrement supérieur au diamètre du câble conducteur 1.In practice, this electrode head 2 thus has a diameter of the order of 2.5 mm in its folded shape corresponding to a lying position of the patient, and a diameter of the order of 4 to 4.5 mm in its deployed position corresponding to the standing position of this patient. In addition, the fact that this electrode head 2 comprises four arches 8 each provided with an active surface, makes it possible to systematically position the latter so that two arches 8 are applied to the internal sheet of the dura mater symmetrically on either side of the spinal cord. As a result, this electrode head 2 makes it possible to obtain symmetrical and bilateral stimulation. The epidural electrode system finally comprises a sheath for introducing the electrode head 2 into the epidural space. This sheath 3 " made of a material such as teflon, polyurethane, silastic, etc., has an internal diameter slightly greater than the diameter of the conductive cable 1.
Ce fourreau 3 présente, en outre, une extrémité légèrement effilée permettant de l'introduire éventuellement sur un guide métallique fin, lui-même passé à travers une aiguille de "TUOHY" conventionnelle. Dans ce cas, le câble conducteur 1 comportera une âme creuse permettant d'introduire coaxialement l'ensemble électrode 2/fourreau 3 sur le guide.This sheath 3 has, in addition, a slightly tapered end allowing it to be introduced optionally onto a thin metal guide, itself passed through a conventional "TUOHY" needle. In this case, the conductive cable 1 will include a hollow core making it possible to introduce the electrode 2 / sheath 3 assembly coaxially onto the guide.
Ce fourreau 3, destiné à loger le câble conducteur 1 et la tête d'électrode 2, dans la configuration totalement repliée de celle-ci, permet d'implanter cette tête d'électrode 2 à l'endroit du site de stimulation choisi.This sheath 3, intended to accommodate the conductive cable 1 and the electrode head 2, in the fully folded configuration thereof, makes it possible to implant this electrode head 2 at the location of the chosen stimulation site.
Une fois ce positionnement effectué, la tête d'électrode 2 est dégagée par un simple recul du fourreau 3 le long du câble conducteur 1, et se déploie radialement, sous l'effet de son élasticité, de façon à venir s'appliquer au moins par sa surface active sur les deux feuillets de la dure- mère.Once this positioning has been carried out, the electrode head 2 is released by a simple retraction of the sheath 3 along the conductive cable 1, and deploys radially, under the effect of its elasticity, so as to come to be applied at least by its active surface on the two sheets of the dura mater.
Après cette mobilisation, le fourreau 3 peut être laissé en place de façon à permettre le retrait de la tête d'électrode 2 et l'introduction éventuelle d'une autre tête d'électrode.After this mobilization, the sheath 3 can be left in place so as to allow the withdrawal of the electrode head 2 and the possible introduction of another electrode head.
Il est à noter que la tête d'électrode 2 décrite ci-dessus est particulièrement adaptée, de par ses dimensions, pour être implantée au niveau de l'étage dorso- lombaire D11-L1. Toutefois, il est évident que ces dimensions
peuvent être modifiées en vue d'implanter cette tête d'électrode au niveau d'étages différents de l'espace epidural postérieur. Par ailleurs, la tête d'électrode peut également être constituée de six arches 8,- trois arches antérieures et trois arches postérieures, réparties régulièrement autour de l'axe du câble conducteur 1. Cette configuration particulière permet d'appliquer une stimulation bi-polaire paramediane, en utilisant l'arche médiane comme anode.It should be noted that the electrode head 2 described above is particularly suitable, by its dimensions, for being located at the level of the dorsolumbar stage D11-L1. However, it is evident that these dimensions can be modified in order to implant this electrode head at different levels of the posterior epidural space. Furthermore, the electrode head can also consist of six arches 8, - three anterior arches and three posterior arches, distributed regularly around the axis of the conductive cable 1. This particular configuration makes it possible to apply bi-polar stimulation paramedian, using the middle arch as an anode.
La figure 8 représente une variante de réalisation d'un système d'électrode epidural conforme à l'invention, comprenant plusieurs têtes d'électrodes 2 espacées le long d'un câble conducteur 1 unique, et constituant une électrode multipolaire multifonctions.
FIG. 8 represents an alternative embodiment of an epidural electrode system according to the invention, comprising several electrode heads 2 spaced along a single conductive cable 1, and constituting a multifunctional multipolar electrode.
Claims
REVENDICATIONS 1 / - Système d'électrode épidurale appelée à être introduite dans l' espace epidural en vue de recueillir et/ou de transmettre un signal électrique, caractérisé en ce qu'il comprend :CLAIMS 1 / - Epidural electrode system called to be introduced into the epidural space in order to collect and / or transmit an electrical signal, characterized in that it comprises:
- un support ( 2 ) radialement é las tique comportant une région équatoriale (8a) et deux régions en forme de fuseau, dites dis tale (8 b ) et proximale ( 8 c) , s'étendant de part et d'autre de ladite région équatoriale, et solidarisées respectivement au niveau des extrémités proximale et distale du support,- a radially elastic support (2) comprising an equatorial region (8a) and two spindle-shaped regions, called dis tale (8 b) and proximal (8 c), extending on either side of said equatorial region, and secured respectively at the proximal and distal ends of the support,
- au moins une zone active conductrice située dans la région équatoriale (8a) du support élastique (2) , et agencée pour subir les mêmes déformations radiales que ledit support,- at least one active conductive area located in the equatorial region (8a) of the elastic support (2), and arranged to undergo the same radial deformations as said support,
- et une liaison conductrice ( 1 ) entre des moyens de transmission électrique et chaque zone active.- And a conductive link (1) between electrical transmission means and each active area.
2/ - Système d'électrode épidurale selon la r evendi cat i o n 1 , ca ra c té r i sé en ce q ue le s up p o rt élastique (2 ) est constitué d'au moins deux arches (8) en forme de cintre solidarisées vers leurs extrémités, et réparties autour de l'axe dudit support.2 / - Epidural electrode system according to re vendi cat ion 1, ca ra c té ri se in that the elastic s up po rt (2) consists of at least two arches (8) in the form of a hanger secured towards their ends, and distributed around the axis of said support.
3/ - Système d'électrode épidurale selon la revendication 2, caractérisé en ce qu'il comprend quatre arches (8) régulièrement réparties autour de l'axe du support (2) .3 / - epidural electrode system according to claim 2, characterized in that it comprises four arches (8) regularly distributed around the axis of the support (2).
4/ - Système d'électrode épidurale selon la revendication 2, caractérisé en ce qu'il comprend six arches régulièrement réparties autour de l'axe du support.4 / - epidural electrode system according to claim 2, characterized in that it comprises six arches regularly distributed around the axis of the support.
5/ - Système d'é lectrode épidurale s elon l'une des revendications 2, 3 ou 4, caractérisé en ce que chaque arche (8) est constituée d'un brin conducteur gainé d'un matériau Isolant, chacun desdits brins étant dénudé sur une longueur au moins équivalente à la région équatoriale (8a) .5 / - epidural electrode system according to one of claims 2, 3 or 4, characterized in that each arch (8) consists of a conductive strand sheathed with an insulating material, each of said strands being stripped over a length at least equivalent to the equatorial region (8a).
6/ - Système d'électrode épidurale selon la revendication 5, caractérisé en ce que chaque arche (8 ) est constituée d'un brin en carbone armé, d'un diamètre sensiblement égal à 0, 3 mm.
7/ - Système d'électrode épidurale selon l'une des revendications précédentes, caractérisé en ce que le support (2) présente une région équatoriale (8a) d'une longueur sensiblement comprise entre 1,5 et 2,5 mm, et deux régions (8b), (8c) en forme de fuseau d'une longueur sensiblement comprise entre 1 et 2,5 mm.6 / - epidural electrode system according to claim 5, characterized in that each arch (8) consists of a strand of reinforced carbon, with a diameter substantially equal to 0.3 mm. 7 / - epidural electrode system according to one of the preceding claims, characterized in that the support (2) has an equatorial region (8a) of a length substantially between 1.5 and 2.5 mm, and two spindle-shaped regions (8b), (8c) of a length substantially between 1 and 2.5 mm.
8/ - Système d'électrode épidurale selon l'une des revendications 5 ou 6, caractérisé en ce que la liaison conductrice est constituée d'un câble conducteur (1) solidaire de l'extrémité du fuseau proximal (8c), et comprenant une extrémité dite proximale dotée d'une fiche (9) de connexion électrique comportant un nombre de contacts équivalent au nombre d'arches (8). 9/ - Système d'électrode épidurale selon la revendication 8, caractérisé en ce que le câble conducteur (1) comporte un nombre de brins conducteurs (4) au moins équivalent au nombre d'arches (8), chacune desdites arches étant constituée par le prolongement d'un desdits brins conducteurs solidarisés entre eux au niveau des extrémités proximale et distale du support (2).8 / - epidural electrode system according to one of claims 5 or 6, characterized in that the conductive connection consists of a conductive cable (1) secured to the end of the proximal spindle (8c), and comprising a said proximal end provided with a plug (9) for electrical connection comprising a number of contacts equivalent to the number of arches (8). 9 / - epidural electrode system according to claim 8, characterized in that the conductive cable (1) comprises a number of conductive strands (4) at least equivalent to the number of arches (8), each of said arches being constituted by the extension of one of said conductive strands secured to each other at the proximal and distal ends of the support (2).
10/ - Système d'électrode épidurale selon la revendication 9, caractérisé en ce que le câble conducteur (1) comprend une gaine (7) d'isolation générale des brins conducteurs (4), ladite gaine, interrompue au niveau de l'extrémité proximale du support (2), étant adaptée pour assurer la solidarisation des brins (4) au niveau de ladite extrémité.10 / - epidural electrode system according to claim 9, characterized in that the conductive cable (1) comprises a sheath (7) for general insulation of the conductive strands (4), said sheath, interrupted at the end proximal of the support (2), being adapted to secure the strands (4) at said end.
11/ - Système d'électrode épidurale selon l'une des revendications 9 ou 10, caractérisé en ce que le câble conducteur (1) comporte au moins quatre brins (4) gainés chacun d'un matériau isolant.11 / - Epidural electrode system according to one of claims 9 or 10, characterized in that the conductive cable (1) comprises at least four strands (4) each sheathed with an insulating material.
12/ - Système d'électrode épidurale selon la revendication 11, caractérisé en ce que chaque brin (4) du câble conducteur (1 ) est armé d'un fil métallique (6).12 / - Epidural electrode system according to claim 11, characterized in that each strand (4) of the conductive cable (1) is armed with a metal wire (6).
13/ - Système d'électrode épidurale selon l'une des revendications 8 à 12, caractérisé en ce qu'il comprend plusieurs supports élastiques (2) espacés le long d'un câble conducteur unique (1). 14/ - Système d'électrode épidurale selon
l'une des revendications précédentes, caractérisé en ce qu' il comprend un dispositif d'introduction et de retrait du support élastique (2) dans l'espace epidural , constitué d'un fourreau (3 ) de diamètre interne adap té pour loger ledit support dans un état radialement replié.13 / - Epidural electrode system according to one of claims 8 to 12, characterized in that it comprises several elastic supports (2) spaced along a single conductive cable (1). 14 / - Epidural electrode system according to one of the preceding claims, characterized in that it comprises a device for introducing and removing the elastic support (2) into the epidural space, consisting of a sheath (3) of internal diameter suitable for housing said support in a radially folded state.
15/ - Système d' électrode épidurale selon l'une des revendications précédentes, caractérisé en ce qu'il comprend un support élastique (2) comportant une zone active au niveau de la seule région équatoriale (8a) .15 / - Epidural electrode system according to one of the preceding claims, characterized in that it comprises an elastic support (2) comprising an active area at the level of the only equatorial region (8a).
16/ - Sys tème d' électrode épidurale selon l'une des revendications 1 à 1 4, caractérisé en ce qu'il comprend un support élastique (2) comportant une zone active dans la région équatoriale , une zone active dans la région distale et une zone active dans la région proximale.
16 / - Epidural electrode system according to one of claims 1 to 1 4, characterized in that it comprises an elastic support (2) comprising an active zone in the equatorial region, an active zone in the distal region and an active area in the proximal region.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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FR9003205A FR2659240B1 (en) | 1990-03-06 | 1990-03-06 | EPIDURAL ELECTRODE SYSTEM CALLED TO BE INTRODUCED INTO THE EPIDURAL SPACE. |
Publications (1)
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WO1993004734A1 true WO1993004734A1 (en) | 1993-03-18 |
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ID=9394679
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/FR1991/000719 WO1993004734A1 (en) | 1990-03-06 | 1991-09-12 | Epidural electrode system intended to be introduced in the epidural space |
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FR (1) | FR2659240B1 (en) |
WO (1) | WO1993004734A1 (en) |
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Also Published As
Publication number | Publication date |
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FR2659240B1 (en) | 1997-07-04 |
FR2659240A1 (en) | 1991-09-13 |
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