FR2942968A1 - APPARATUS USED IN TRANSCRANIAL STIMULATION USING A MAGNETIC STIMULATION ANTENNA - Google Patents

Abstract

The invention relates to an apparatus (1) used in the context of a transcranial stimulation using a magnetic stimulation antenna. According to the invention, the apparatus comprises at least one instrument (3) for holding a person's head, comprising: - a support (4) for supporting the head, - a device (17) for fixing the supporting support (4) to a support frame (18) - and a mounting structure (30) for the magnetic stimulation antenna, mounted on the support support (4) and for moving the antenna relative to the support (4), this mounting structure (38) being equipped with locking means for placing the antenna in a fixed position relative to the support support (4).

Description

The present invention relates to the general technical field of transcranial magnetic stimulation (SMT) and more specifically to an apparatus for use in the context of a transcranial stimulation using a magnetic antenna.

In general, the transcranial magnetic stimulation technique consists, after identifying a target zone of the brain, to emit, on this target area, a specific magnetic field using an antenna causing modifications of the neuronal activity. The magnetic stimulation technique has many medical applications where therapeutic effects are known notably in neurology for the treatment of motor disorders, in the algology for the treatment of pain or in psychiatry for the treatment of chronic depression, obsessive-compulsive disorders, post-traumatic stress, schizophrenia, etc.

A device for providing transcranial stimulation generally comprises a generator connected to a transmitting antenna mounted on a gripping support so as to enable it to be positioned facing the target zone of the brain. The positioning of the magnetic stimulation antenna is carried out for example by neuronavigation, by functional response, with the aid of magnetic resonance imaging tracking equipment, etc. Maintaining the position of the antenna in relation to the target zone is often a delicate operation to carry out. For example, it is known to maintain the antenna in a rudimentary manner using, for example, a bracelet or an adhesive holding strip.

The positioning of the antenna directly on the patient's head leads to inconvenience and difficulty in setting up and maintaining in a precise position. In addition, it should be noted that most transcranial magnetic stimulation applications require repeated stimulation of the same areas of the brain. The known prior art does not offer the possibility of simply and repeatedly positioning the stimulation antenna with respect to a target zone of the brain.

The present invention therefore aims to remedy the drawbacks of the state of the art by proposing a new apparatus that can be used in the context of a transcranial stimulation performed using a magnetic stimulation antenna, this apparatus being designed to enable to position the magnetic stimulating antenna in a simple and precise manner without causing any inconvenience to the patient. Another object of the invention is to provide an apparatus providing the possibility of positioning the magnetic stimulation antenna in a precise position and repeatedly.

To achieve such an objective, the present invention relates to an apparatus used in the context of a transcranial stimulation using a magnetic stimulation antenna. According to the invention, the apparatus comprises at least one holding instrument for the head of a person, comprising: a support support for the head, a device for fixing the support support to a support frame, and a mounting structure for the magnetic stimulation antenna, mounted on the support support and for moving the antenna relative to the support support, this mounting structure being equipped with locking means for placing the antenna in a fixed position relative to the support support. The apparatus according to the invention can be implemented with one and / or the other of the following characteristics: the support support comprises at least one posterior support and anterior support for the head, the support of support comprises means for adjusting the relative position of the posterior support relative to the previous support, the means for adjusting the relative position of the anterior support relative to the posterior support comprise two movable mounted rings 30 in rotation relative to a body, on either side of the posterior support being each traversed by a leg of a bow provided with the front support and able to slide relative to the rings, each ring being provided with a member ensuring the angular locking of the ring and the blocking sliding of the bow, the bow is equipped on each of its branches, a temporal support member, the fixing device comprises a flexible system allowing soft the fastening device comprises as a flexible system, a fastening tab extending from the body and whose rigidity is adapted to allow the limited bending of the support of support in a sagittal plane and in a frontal plane. Another object of the invention is to provide an apparatus adapted to identify a zone or a target position of the patient's head with respect to which the stimulation antenna is to be positioned.

To achieve such an objective, the apparatus according to the invention comprises a removable frame for locating a target position in the space with respect to which the stimulation antenna is to be positioned, this removable frame comprising: a base provided with a positioning system of the frame relative to the head, equipped with at least one support member on the holding instrument, and a mobile structure mounted on the base and equipped with a locating element of the target position , this mobile structure being provided with locking means for placing the marker element in a fixed position. The removable frame can be implemented with one and / or the other of the following characteristics: the mobile structure is provided with graduations making it possible to know the position of the locating element with respect to the base, the structure mobile comprises: o a semicircular arc mounted at each of its ends, pivoting on the base according to a half-axis establishing in the frontal plane, o a slide mounted movably sliding along the semicircular arc , o a platform for mounting the marker mounted movably on the slide, o and locking means in position of the semicircular arc, the positioning system of the frame has two insertion rods in the auditory canals coaxially mounted to each other being adjustable in spacing-approximation relative to each other, the support member being slidably mounted in a direction perpendicular to the rods and being provided with a double FourC he anchor on the previous support.

Another object of the invention is to provide an apparatus adapted to locate with coordinates a zone or a target position of the brain of a patient. For this purpose, the apparatus according to the invention comprises an imaging material comprising a U-shaped body provided with two mounting rods in the auditory ducts and an anterior support member, the U-shaped body being equipped with markers detectable by MRI. The apparatus also comprises a system for converting the coordinates of a target point determined using the co-ordinate locating material identifiable by the marker element carried by the movable structure of the removable frame mounted on the support support of the sustaining instrument. Various other characteristics appear from the description given below with reference to the accompanying drawings which show, by way of non-limiting examples, embodiments of the subject of the invention.

Figure 1 is a perspective view of a holding instrument according to the invention forming part of an apparatus used in the context of transcranial stimulation.

Figure 2 is a 3/4 perspective rear view of the holding instrument illustrated in FIG. 1 and provided with a stimulation antenna. Figure 3 is a perspective of a removable locating frame forming part of an apparatus according to the invention.

Figures 4 and 5 are perspective respectively of profile and top of the removable locating frame mounted on a holding instrument. Figure 6 is a perspective of imaging tracking equipment. As is more particularly apparent from Figs. 1 and 2, the object of the invention relates to an apparatus 1 adapted to be used in the context of a transcranial stimulation of a zone or a target point of the brain by implementing a magnetic stimulation antenna 2. The apparatus 1 according to the invention comprises at least one instrument 3 ensuring the maintenance of the head of a person, but also the support of the magnetic stimulation antenna 2 in a precise position of the space as a function of the target area. For the sake of clarity, the maintenance of a head is considered with respect to the frontal plane or front view F, sagittal plane S that is to say the vertical plane perpendicular to the frontal plane F, to the transverse plane, c that is, the horizontal plane perpendicular to the sagittal and frontal planes.

The holding instrument 3 comprises a support support 4 for the head of a person, adapted to maintain the head during the implementation of the magnetic stimulation. Advantageously, the support support 4 allows maintenance of the head in at least two opposite sides of the head. In the exemplary embodiment illustrated in the drawings, the support support 4 comprises at least one posterior support 6 for the head and an anterior support 7 for the head. According to a preferred embodiment, this holding instrument 3 comprises means 9 for adjusting the relative position of the anterior support 7 with respect to the posterior support 6 so as to allow the passage of the head and the adaptation of the this instrument of maintenance 3 to different sizes and shapes of people's heads.

According to a preferred embodiment, the posterior support 6 is in the form of a support cushion shaped diabolo to allow support for the neck of the patient. This posterior support 6 is carried by a body 10 made in the example illustrated in the form of a stirrup. For example, the support cushion 6 is mounted between the branches of the stirrup 10 being carried by a not shown shaft projecting from the support cushion 6 which is thus engaged between the two branches of the stirrup 10. The front support 7 is carried by a hoop 12 of generally U-shaped supported by the body 10. The hoop 12 thus has two branches 121 extending parallel to one another and connected by a portion of link in which the medium is provided with the anterior support 7. In the exemplary embodiment illustrated, the anterior support 7 is intended to be positioned at the level of the crown of the patient's nose. In the illustrated example, this front support 7 has a diabolo shape being coated or not with a soft material in contact. Similarly, the posterior support cushion 6 may be provided with a soft contact coating for the patient's head. According to a preferred embodiment, the adjustment means 9 allow between the posterior support 6 and the front support 7 on the one hand a relative approximation and spacing and, on the other hand, an adjustable relative angulation. In the illustrated example, the two branches 121 of the hoop 12 are engaged in rings 14 mounted on the shaft protruding from the branches of the stirrup 10. These rings 14 each comprise a bore allowing the passage of a branch. 121 of the hoop 12 thus allowing the hoop to slide relative to the body 10. The rings 14 are mounted free to rotate about the axis so as to allow the rotation of the hoop in the sagittal plane S allowing the relative angulation between the supports. Each ring 14 is provided with a member 15 such as a clamping screw for ensuring the angular locking of the ring 14 and the sliding locking of the arch 12. The holding instrument 3 also comprises a fixing device 17 support support 4 to a support frame 18 in the general sense such as an armchair or a bed for example. According to a preferred embodiment, the fixing device 17 comprises a flexible system 20 allowing limited movements of the support 4 relative to the support frame 18 to improve the comfort of the patient during the implementation of the technique of magnetic stimulation. This flexible system 20 thus allows movements on a limited stroke in one or more directions. In the exemplary embodiment illustrated, the flexible system 20 allows the movements of the support support in at least two directions and with a limited amplitude in each of these directions. For example, the flexible system 20 allows the bending of the support support 4 in the sagittal plane S and its rotation about its vertical axis Z allowing a rotation in the transverse plane T. It should be understood that the fastening device 17 ensures complete blocking of the head with the exception of a possibility of limited inclination from front to back of the head and rotation of the head from left to right and vice versa. For example, these movements are limited to an angular amplitude at most equal to 15 °. This limited freedom of movement prevents the patient the phenomenon of stress attached to a complete blockage of the head. In the exemplary embodiment illustrated, the flexible system 20 is made by a fixing lug fixed on the body 10. This fixing lug 20 has a rigidity adapted to ensure the fixed position of the support support 4 to the except for the possibility of bending in the sagittal plane S and rotation about its longitudinal axis in limited amplitudes. This fixing lug 20, which has a generally elongated flat shape, comprises a series of holes 25 for adjusting its fixing position on the support frame 18. The locking in position of the lug 20 on the support frame 18 is provided for example The holding instrument 3 also comprises a mounting structure 30 for the magnetic stimulation antenna 2. This structure 30 is supported by the support support 4 and allows the positioning of the support to be adjusted. magnetic stimulation antenna 2 relative to the head, that is to say relative to the support support 4. In the example illustrated, the mounting structure 30 comprises a rod 31 fixed on the body 10 to the using a ring 311. This rod 31 extends from the body 10 in a direction opposite to that of extension of the arch 12. This mounting structure 30 also comprises a ring 32 mounted to slide on the rod 31 and supporting an articulated compass 33 at the end of which is mounted a receiving member 34 of the magnetic stimulation antenna 2. The ring 32 can be locked in position along the rod 31 by a locking member 35, such as a clamping screw. Similarly, the articulation of the compass 33 is provided with a locking element 36 enabling the magnetic stimulation antenna 2 to be locked in a fixed position with respect to the body 10. It should be noted that the receiving member 34 can in the illustrated example, the receiving member 34 is provided with a bore for receiving the handle 21 of the antenna which is locked in position. By means of the above description it will be seen that the holding instrument 3 according to the invention makes it possible to provide a function for holding the head of a person, combined with a support function for the body. Magnetic stimulation antenna 2. It should be noted that the magnetic stimulation antenna 2 is not supported by the patient, but by the body 10. Advantageously, the holding instrument 3 offers a possibility of movements limited to the t is guaranteeing relative comfort to the patient. The use of the holding instrument 3 according to the invention is relatively simple to carry out and follows from the foregoing description. After fixing the support support 4 to a frame 18 with the aid of the fixing device 17, the patient's head is placed in support, by its nape, on the posterior support 6. To facilitate this maneuver, the The hoop 12 is pivotally or retracted away from the support 10. The hoop 12 is then pivotally and / or slidably displaced so that the anterior support 7 comes into contact with the upper part of the nose. The locking of the clamping screws 15 makes it possible to obtain a good hold of the head in the clamped or pinched position between the posterior supports 6 and front 7, with the possibility of micromovements as explained above. It should be noted that according to a preferred embodiment, the hoop 12 can be equipped on each of its branches, a temporal support member 38. For example, each temporal support member 38 is mounted on a ring 39 slidably mounted on a leg of the hoop 12 and locked in position by a locking screw 39i. After mounting the magnetic stimulation antenna 2 on the receiving member 34, the mounting structure 30 is adjusted so that the antenna 2 is positioned in relation to the target area of the brain. The positioning of the antenna 2 in relation to a target zone can be carried out in any appropriate manner. The mounting structure 30 is then locked to maintain the antenna 2 in its final position. For this purpose, the locking member 35, the locking member 36 and the receiving member 37 are blocked. It should be noted that the antenna 2 follows the micromovements of the body 10. Thus, once the antenna 2 is locked in position and the patient's head is held tight between the posterior supports 6 and front 7, the movements of the patient's head do not change the relative position of the antenna 2 relative to the head. According to another object of the invention, the apparatus 1 according to the invention comprises a removable frame 40 for locating a target position in the space with respect to which the magnetic stimulation antenna 2 is to be positioned.

As can be seen from FIG. 3, this removable frame 40 comprises a base 41 provided with a positioning system 42 of the frame 40 relative to the head. Preferably, this positioning system 42 is provided with at least one support member 43 on the holding instrument 3 as it appears more specifically in FIGS. 4 and 5. In the exemplary embodiment illustrated, the support member 43 is intended to be supported at the level of the anterior support 7 of the support 4. 2942968 IO The base 41 of generally triangular shape has two 411 arms interconnected in a central zone equipped with the support member 43. In the illustrated example, the support member 43 comprises a rod 44 slidably mounted on the base 41. The rod 44 is provided at one end of a double fork 45 intended to be anchored on the hoop 12 on either side of the front support 7 as shown in FIG. 5. The two arms 411 are provided, at each of their free end, with an insertion rod 46 in an auditory canal. The two rods 46 are mounted coaxially to one another by being adjustable in spacing-approximation 10 relative to each other. For this purpose, each rod 46 slides inside bores arranged in two fingers 412 extending from each end of the branches 411. The two rods 46 and the rod 44 extend in a plane. The rod 44 of the support member 43 slides in a direction perpendicular to the direction of the insertion rods 46. Of course, the rods 44, 46 are slidably adjustable to allow correct and precise positioning on the head. Preferably, the rods 44, 46 are equipped with locking members to lock them in position after adjustment. According to an advantageous embodiment, the rods 44, 46 are provided with graduations to identify their position of extension relative to the base 41. It should be noted that the correct positioning of the frame 40 on the head is obtained when the two rods 46 protrude from the base 41 according to an identical value. In this position, the axis passing through the rod 44 of the support member 43 intersects the axis passing through the two rods 46, in the middle of the distance separating said rods 46. The removable frame 40 also comprises a structure mobile 48 mounted on the base 41 and equipped with a locating element 49 of the target position. This mobile structure 48 is adapted to allow positioning of the locating element 49 at any point in the space 30 corresponding to the target point of the brain. In the exemplary embodiment illustrated, this mobile structure 48 comprises a semicircular arc 51 pivotally mounted at each of its ends, on the base 41 along a half-axis 52 carried by the base 41. As can be seen in FIGS. . 3 to 5, the half-shafts 52 are mounted in a collinear manner in coincidence with the insertion rods 46. This semicircular arc 51 is pivotally mounted around the half-shafts 52, having as a center of rotation, the point d intersection of the axis passing through the rod 44 with the axis passing through the two rods 46. These half-axes 52 are established in the frontal plane F so that the semicircular arc 51 can pivot around the head in the sagittal plane S to be placed in a determined position substantially covering the front to the nape of the neck. This semicircular arc 51 is locked in position by locking means 53 such as a lever. The movable structure 48 also comprises a slider 55 slidably mounted along the semicircular arc 51. The slider 55 is therefore able to be displaced in the plane of the semicircular axis 51 over an angular range of 1 order of 180 °. This slider 55 is provided with a mounting platform 56 on which is mounted the marker element 49. According to an advantageous embodiment, the mounting platform 56 is mounted relative to the slider 55, with a possibility of movement to allow to locate any target point of the brain. In the exemplary embodiment, this mounting platform 56 allows the pivoting element 49 to pivot with respect to the slider 55 in the plane perpendicular to the plane containing the semicircular arc 51. For this purpose, the platform 56 is provided with a pivot axis 57 parallel to the plane defined by the semicircular arc 51, and on which is articulated the locating element 49 (Figure 4). Advantageously, the angular position of the locating element 49 in the plane perpendicular to the plane defined by the semicircular arc 51 is marked by graduations arranged on a disk 60 carried by the platform 56 (FIG 3). Preferably, the mounting platform 56 is rotatably mounted on the slide 55 according to a not shown axis being established perpendicularly to the plane defined by the semicircular arc 51. In this plane, the mounting platform 56 can rotate according to an angular range of 360 °. The angular position of the platform 56 in the plane defined by the semicircular arc 51 is marked by graduations made on the slider 55 (FIG 3). As is apparent from the foregoing description, the removable frame 40 makes it possible to position a locating element 49 such as a laser beam in any of the locations of the brain likely to constitute a target zone. According to the preferred embodiment described above, the mobile structure 48 is provided with graduations to know the position of the locating element 49 relative to the base 41. For this purpose, the half circular arc 51 has along its entire length graduations for locating the position of the slider 55 on the semicircular arc 51. Similarly, the base 41 is provided with a graduated disc 61 to know the angular value of extension of the semicircular arc 51 relative to the base 41. Similarly, as explained above, the mounting platform 56 has graduations to know the angular orientation and inclination of the locating element 49 relative to The removable frame 40 makes it possible to easily locate a target position on the head and consequently also to position the antenna 2 with respect to this target position. Indeed, the removable frame 40 is adapted to the patient's head by the introduction of the rods 44, 46 in the ear canals and the fixation of the support member 43 on the arch 12 of the holding instrument 3 The movable structure 48 is moved so that the registration element 49 can aim at the target point. For this purpose, the semicircular arc 51 is pivoted and locked in position. The slider 55 and the platform 56 are moved and positioned so that the registration element 49 occupies its aiming position of the target point. It should be noted that the slider 55 and the platform 56 are adapted to remain in position only because of the friction involved. The correct positioning of the antenna 2 with respect to the target position identified on the patient's head can be achieved. in any appropriate way. After the positioning of the antenna 2 relative to this target position, the frame 40 can be removed during the implementation of the transcranial stimulation.

Note that the frame 40 can be used again to locate the same target area using the settings (i.e. ticks) to place the registration element 49 in its aiming position. The antenna 2 can thus be positioned easily during the repeated sessions necessary for the implementation of the transcranial stimulation technique. According to another object of the invention, the apparatus 1 according to the invention comprises an imaging locating material 70 adapted to locate, that is to say, to determine the coordinates of the target zone of the brain in a reference frame. adapted, for example from Leksell.

In the exemplary embodiment illustrated in FIG. 6, the marking material 70 comprises a U-shaped body 71 provided with two rods 72 for mounting in the auditory ducts extending opposite each other at a distance from one another and coaxially to each other. other. The body 71 is also provided with an anterior support member 73 whose axis intersects the axis passing through the two mounting rods 72. The two mounting rods 72 are slidably mounted and are provided with graduations so that in the correct mounting position of the marking material 70 on the head, the two rods 72 project from the body 71 in an identical value. These two rods are locked in position by locking members 74.

In this symmetrical position of the rods, the axis passing through the anterior support member 73 intersects the axis passing through the two rods 72, in the middle of the distance between the two rods 72. The body 71 is equipped with marks 75 detectable by MRI. In the illustrated example, these detectable marks 75 are made by two N-shaped bodies. The imaging locating material 70 allows initial identification of the target area of the brain to be treated: either with the aid of the atlas Talairach (proportional atlas can find any areas of the brain by anatomical proportion) and a software for converting the coordinates of the target area in the frame of removable frame 40 to determine the coordinates to position the Antenna 2, - either using MRI exams with the use of software / charts to determine the target coordinates of the areas to be reached in MRI, and convert them into the frame of removable frame 40 using • software / charts.

It must be considered that the imaging registration material 70 must be used in association with a system (charts or software) ensuring the conversion of the coordinates of a target point determined using the marking material 70 in coordinates locatable on the removable frame 40 to place the marker element 49 in the position of said target point.

The invention is not limited to the examples described and shown because various modifications can be made without departing from its scope.

Claims (1)

CLAIMS1 - Apparatus (1) used in the context of transcranial stimulation using a magnetic stimulation antenna (2), characterized in that it comprises at least one instrument (3) for holding a person's head , comprising: - a support (4) for supporting the head, - a device (17) for fixing the support support (4) to a support frame (18) and a mounting structure (30) for the magnetic stimulation antenna (2), mounted on the support support (4) and for moving the antenna relative to the support support (4), this mounting structure (38) being equipped with locking means for place the antenna in a fixed position relative to the support (4). 2 Apparatus according to claim 1, characterized in that the support support (4) comprises at least one posterior support (6) and an anterior support (7) for the head. 3 - Apparatus according to claim 2, characterized in that the support support (4) comprises means (9) for adjusting the relative position of the posterior support (6) relative to the anterior support (7) . 4 - Apparatus according to claim 3, characterized in that the adjusting means (9) of the relative position of the anterior support (7) relative to the posterior support (6) comprise two rings (14) mounted movably in rotation relative to a body (10), on either side of the posterior support (6) each being traversed by a leg of a bow (12) provided with the front support (7) and adapted to relatively slide relative to the rings (14), each ring (14) being provided with a member (15) ensuring the angular locking of the ring and the locking sliding of the arch. 5 - Apparatus according to claim 4, characterized in that the bow 30 (12) is equipped on each of its branches, a temporal support member (38) .6 - Apparatus according to claim 1, characterized in that that the fixing device (17) comprises a flexible system (20) allowing limited movements of the support support (4) relative to the support frame (18). 7 - Apparatus according to claim 6, characterized in that the fastening device (17) comprises as a flexible system (20), a fastening tab extending from the body (10) and whose rigidity is suitable for allow limited flexion of the support support (4) in a sagittal plane and in a frontal plane. 8 - Apparatus according to one of claims 1 to 7, characterized in that it comprises a removable frame (40) for locating a target position in the space with respect to which the stimulation antenna (2) is to be positioned , this removable frame comprising: a base (41) provided with a positioning system (42) of the frame with respect to the head, equipped with at least one support member (43) on the holding instrument ( 3), and a movable structure (48) mounted on the base (41) and equipped with a locating element (49) of the target position, this mobile structure being provided with locking means for placing the element of locating (49) in a fixed position. 9 - Apparatus according to claim 6 or more, characterized in that the movable structure (48) is provided with graduations to know the position of the registration element relative to the base (41). 10 - Apparatus according to claim 6, characterized in that the movable structure (48) comprises: a semicircular arc (51) mounted at each of its ends, pivoting on the base (41) along a half-axis ( 52) being established in the frontal plane, - a slider (55) slidably mounted along the semicircular arc (51), a mounting platform (56) of the locating element (49). mounted movably on the slider (55), and locking means (53) in position of the semicircular arc (51). 11 - Apparatus according to claim 8, characterized in that the system (42) for positioning the frame (40) comprises two rods (46) for insertion into the auditory ducts mounted coaxially to one another by being adjustable in spacing-approaching relative to each other, the support member (43) being slidably mounted in a direction perpendicular to the rods (46) and being provided with a double anchoring fork (45) on the previous support (7). 12 - Apparatus according to one of claims 1 to 11, characterized in that it comprises a material (70) for locating imaging having a body (71) in U provided with two rods (72) for mounting in the ear canals and an anterior support member (73), the U-shaped body being provided with MRI detectable markers (75). 13 - Apparatus according to claim 12, characterized in that it comprises a system for converting the coordinates of a target point determined using the marking material (70) in coordinates identifiable by the registration element carried by the mobile structure (48) of the removable frame (40) mounted on the support support (4) of the holding instrument.