Device for treating the sensory capacity of a person and method of treatment with the help of such a device

Abstract

A system for treating at least one sensory capacity of a person with the help of a stimulation device comprises an electronic converter of a sensory signal into an electronic signal for controlling at least one transducer for emitting signals that are images of the sensory signal. The stimulation device for direct ultrasound stimulation of the sensory cortex of a brain comprises at least one support that is implantable in a skull and that includes at least one internal wall and at least one ultrasound transducer carried by the support. Means for emitting focused ultrasound waves through the internal wall of the support towards a determined zone of the sensory cortex of the patient's brain in order to generate modulation of the brain activity in the cortex are provided. The ultrasound transducer is driven by the electronic converter to emit focused ultrasound signals that are images of the sensory signal.

Claims

1. A system for treating at least one sensory capacity of a person with a help of a stimulation device comprising an electronic converter for converting a sensory signal into an electronic signal for controlling at least one transducer for emitting signals that are images of the sensory signal, the system being characterized in that the stimulation device is a device for direct ultrasound stimulation of a sensory cortex of a patient's brain, the ultrasound stimulation device comprising: at least one support that is adapted to be implanted in a patient's skull and that includes at least one internal wall; and at least one ultrasound transducer carried by the support (2) and adapted for emitting ultrasound waves (U) through the internal wall of the support towards a determined zone of the sensory cortex of the patient's brain in order to generate modulation of a brain activity in the cortex, the ultrasound transducer being driven by the electronic converter to emit ultrasound signals that are images of the sensory signal; wherein the ultrasound stimulation device is provided with a flap presenting an internal face through which ultrasound waves are emitted, wherein the flap is designed to be slid between hemispheres of the patient's brain; wherein the flap is concave and semi-rigid and the implanted support comprises an internal face through which ultrasound waves are emitted, and the flap has ultrasound waves also emitted therethrough.

2. A treatment system according to claim 1, characterized in that the electronic converter has its input connected to at least one sensor adapted to pick up a sensory signal present in an environment of the person.

3. A treatment system according to claim 1, characterized in that the support comprises a fastener for fastening to the patient's skull and the support having an external wall (21) connected to the internal wall via a peripheral wall.

4. A treatment system according to claim 2, characterized in that the sensor is an image acquisition system and in that the ultrasound transducer focuses the ultrasound waves towards a determined zone of a patient's visual cerebral cortex.

5. A treatment system according to claim 1, characterized in that the internal wall of the support includes an external surface covered in a flexible material of varying thickness to provide a continuous contact interface with the brain or a dura mater and to facilitate propagation of ultrasound waves into the brain.

6. A treatment system according to claim 1, comprising an external remote control for controlling and driving the ultrasound stimulation device wirelessly.

7. A treatment system (1) according to claim 1, comprising an external control device connectable to the ultrasound stimulation device (3).

8. A treatment system according to claim 1 comprising at least one rechargeable battery arranged in the support or implanted under a skin of the patient's body.

9. A treatment system according to claim 1, comprising electrodes on an external contact surface of the internal wall of the support for monitoring an electrical activity of the brain and for preventing any epileptic event.

10. A treatment system according to claim 1, comprising an emergency stop switch in a top wall of the support.

11. A treatment system according to claim 1, wherein the electronic converter has an input thereof connected to a system for delivering computerized sensory information that is stored in said system or that comes from a remote appliance.

12. A method of treatment comprising using ultrasound waves emitted in a cranium of a patient in order to stimulate a determined zone of a sensory cortex of a patient's brain using a treatment system, wherein the method further comprises: forming a craniectomy hole in the patient's cranium in register with a zone of a primary visual cortex of the brain; opening dura mater; sliding a flap of an ultrasound stimulation device between the brain hemispheres; and emitting ultrasound waves through an internal face of the flap; wherein the treatment system comprises: an electronic converter for converting a sensory signal into an electronic signal for controlling at least one transducer for emitting signals that are images of the sensory signal, the treatment system being characterized in that the ultrasound stimulation device is a device for direct ultrasound stimulation of the sensory cortex of the patient's brain, the ultrasound stimulation device comprising: at least one support that is adapted to be implanted in the patient's skull and that includes at least one internal wall; and at least one ultrasound transducer carried by the support and adapted for emitting ultrasound waves through the internal wall of the support towards the determined zone of the sensory cortex of the patient's brain in order to generate modulation of a brain activity in the cortex, the ultrasound transducer being driven by the electronic converter to emit ultrasound signals that are images of the sensory signal; wherein the ultrasound stimulation device is provided with the flap presenting an internal face through which ultrasound waves are emitted, wherein the flap is designed to be slid between hemispheres of the patient's brain and is used after the support has been mounted in the patient's skull in register with the zone for treatment of the sensory cortex of the brain; wherein the flap is concave and semi-rigid and the implanted support comprises an internal face through which ultrasound waves are emitted, and the flap has ultrasound waves also emitted therethrough.

13. A method of treatment according to claim 12, characterized in that a frequency of the emitted ultrasound waves lies in a frequency range 200 kHz to 10 MHz, approximately.

14. A method of treatment according to claim 12, characterized in that an electrical activity of the brain is monitored continuously in the target zone of the cortex for ultrasound emission in order to adjust the power of the transmitted ultrasound waves and to prevent any epileptic event.

15. A method of treatment according to claim 12, comprising recording reflected ultrasound waves returned by the brain so as to determine the acoustic attenuation index of the brain.

16. The treatment system according to claim 1, wherein the flap has a concave shape suitable for stimulating the median visual cerebral cortex.

17. The treatment system according to claim 1, wherein the flap has ultrasound transducers mounted therein.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Various other characteristics appear from the following description with reference to the accompanying drawings that show embodiments of the invention as non-limiting examples.

(2) In the accompanying figures:

(3) FIG. 1 is a fragmentary section of the brain in a magnetic resonance image showing the brain zone of Heschl's gyrus forming the primary auditory cortex, and the principle of activating this brain zone with the help of a system of the invention;

(4) FIG. 2 is a diagrammatic section of the deafness treatment system of the invention implanted in a patient's skull in order to stimulate the primary auditory cortex of the patient's brain in accordance with the treatment method of the invention;

(5) FIG. 3 is a diagrammatic longitudinal section of a first embodiment of deafness treatment system in accordance with the invention;

(6) FIG. 4 is a diagrammatic longitudinal section of a second embodiment of a deafness treatment system in accordance with the invention;

(7) FIGS. 5A and 5B show two respective variant embodiments of the bottom surface of the implantable unit of the treatment system of the invention;

(8) FIGS. 6A and 6B show two respective variant embodiments of the top surface of the implantable unit of the treatment system of the invention;

(9) FIG. 7 is a diagrammatic section view of a vision treatment system in accordance with the invention implanted in the skull of a patient to stimulate the patient's visual cerebral cortex;

(10) FIG. 8 is a diagrammatic posterior view of a patient's skull fitted with a vision treatment system in accordance with the invention; and

(11) FIGS. 9 and 10 are respectively an outside view and an inside view of an embodiment of a vision treatment system in accordance with the invention.

DETAILED DESCRIPTION OF THE INVENTION

(12) The present invention proposes a novel approach for treating the sensory capacities of patients. FIG. 1 to GB relate to an application of the invention in which the sensory capacity treated is hearing and in particular deafness in patients suffering from sensorineural and/or transmissive deafness. As shown diagrammatically in FIGS. 1 and 2, this new approach consists in ultrasound stimulation of the primary auditory cortex of the brain B of a patient by means of a treatment system 1 that is implantable subcutaneously in the patient's skull C and comprising an ultrasound stimulation device 3 suitable for emitting ultrasound waves U that are focused on the zone of Heschl's gyrus (BA41) and/or of the planum temporale (BA42) that form the primary auditory cortex of the human brain B. The ultrasound waves U that are emitted are pulsed waves, modulated by an electronic converter of the ultrasound stimulation device 3 as a function of a sensory signal, and more precisely of external sounds S, for example, that are sensed by at least one sensor such as a microphone 6 connected to said ultrasound stimulation device 3.

(13) As shown in FIGS. 2 to 4, the deafness treatment system 1 of the invention comprises a support such as unit 2 for implanting in a patient's skull C, in particular in a burr hole made in register with the zone of the brain B that forms the primary auditory cortex. This unit 2 may be of any shape, and in particular it may be circular or rectangular in section. Advantageously, the unit 2 is made of a non-ferromagnetic material so as to ensure that it is compatible with magnetic resonance imaging (MRI). It comprises a top or external wall 21 and a bottom or internal wall 22 which are connected together by a peripheral wall 23, and it also comprises fastener means 24 for fastening the housing 2 to the patient's skull. The fastener means 24 may comprise fastener tabs 25 projecting from the sides of the top wall 21 of the unit 2 and through which screws are inserted as shown in FIGS. 6A and 6B, or they may be screw threads on the outside surface of the peripheral wall 23 to allow the unit 2 to be screwed into the burr hole in the skull. When fixed in position, the unit 2 passes right through the skull C so that its bottom wall 22 leads directly onto the brain B, as shown in FIGS. 3 and 4.

(14) An ultrasound stimulation device 3 is arranged inside the unit 2. This ultrasound stimulation device 3 comprises at least one ultrasound transducer 4, and preferably a plurality of them, mounted and oriented in the unit 2 to emit pulsed ultrasound waves 5 through the bottom wall 22 of the unit 2 in order to generate neural depolarization and thus brain activity in the primary auditory cortex as a function of ambient sound S picked up by the microphone(s) 6. As explained above, the ultrasound stimulation device 3 includes means for emitting focused ultrasound waves U through the bottom wall 22 of the unit 2 without passing through the skull C and towards a determined zone of the primary auditory cortex of the patient's brain. The bottom wall 22 is thus made of a material that is permeable to ultrasound waves.

(15) As shown in FIG. 5A, the bottom wall 22 of the unit 2 is preferably made up completely or at least in part of ultrasound micro-transducers 4 covering at least 50% of the area of said bottom wall 22 of the unit 2.

(16) In one embodiment of the invention, the bottom wall 22 of the unit 2 may have an outer surface that is covered in a flexible material of varying thickness in order to procure a continuous contact interface with the brain or the dura mater in the patient's skull C and thus facilitate the propagation of ultrasound waves U into the brain B. The bottom wall 22 of the unit 2 is made of a biocompatible material, given that it is implanted inside the skull C.

(17) In the invention, the ultrasound transducers 4 may be selected from piezo-composite elements, piezo-ceramic elements, capacitive micro-machined ultrasonic transducers (CMUTs), polyvinylidene fluoride (PVDF) elements, or other elements suitable for emitting pulsed ultrasound waves.

(18) The ultrasound waves U emitted by the transducers arranged in the unit are pulsed ultrasound waves that are focused towards the primary auditory cortex (zones BA41, BA42) of the brain for specifically and selectively modulating the activity of the brain over a zone of very small area. The focused ultrasound waves U thus reach this zone of the brain B directly without passing through the skull C, insofar as the bottom wall 22 of the unit 2 through which the ultrasound waves pass is in contact with the brain B. The ultrasound waves emitted by the device of the invention are preferably at a frequency of the order of 200 kHz to 10 MHz.

(19) This frequency range is particularly suitable and necessary for adapting the emission and treatment parameters of the system 1 of the invention to any patient and to any anatomical configuration, and in particular for enabling the ultrasound beam to be correctly oriented and for enabling the beam to be focused during treatment by varying the phase differences between the emitters, by adding filters, by adding acoustic lenses, or by a combination of these means.

(20) In the example shown in the drawings, the ultrasound stimulation device 3 is placed inside a support that is in the form of a unit 2 provided with fastener means 25 for fastening to the patient's skull. It should be observed that it is possible to envisage placing the ultrasound stimulation device 3 inside a support made in the form of a membrane that is inserted inside a skull C and that includes an internal face through which the ultrasound waves are emitted and that comes into contact with the brain or the dura mater.

(21) The ultrasound stimulation device 3 also has at least one microphone 6 adapted to pick up audible ambient sounds in the direct environment of the implanted patient. The microphone 6 in a preferred first embodiment may be positioned in the top wall 21 of the unit 2 as shown in FIG. 6A. Where appropriate, and as shown in FIG. 6B, a plurality of microphones 6 may be used so that each microphone 6 picks up a determined range of sound wavelengths.

(22) With a single microphone 6, it is also possible to envisage separating the microphone 6 from the unit 2, in particular in order to position it in the pinna of the patient's ear and to transmit information by wire or wirelessly to the unit 2 implanted in the patient's skull C. It is also possible in the same manner to use two microphones 6, each implanted in a respective one of the patient's pinnas in order to pick up ambient sounds S in stereo.

(23) The microphone(s) 6 is/are connected inside the unit 2 to an electronic converter 7 for decoding the sensed sounds S into electronic signals for controlling the ultrasound transducers 4. By means of the converter, the ultrasound waves U emitted by the ultrasound transducers 4 thus form ultrasound signals that are images of the sounds S sensed by the microphone(s) 6.

(24) From the above description, it can be seen that the electronic converter 7 has its input connected to the microphone 6 in order to convert the sounds picked up by the microphone 6 into control signals for the ultrasound transducers 4. Naturally, the electronic converter 7 may serve to convert sounds that have not been picked up by a microphone, but that are generated by a simulation system incorporated in or remote from the stimulation device 3. In this embodiment, the input of the electronic converter 7 is connected to the simulation system in order to convert the simulated sound signals into control signals for the ultrasound transducers 4.

(25) In an embodiment, the auditory information may come directly from computer data taken from computer files without it being necessary to have an auditory detection system (microphone). This makes it possible in a manner that is real to the brain to deliver computerized sensory information that is entirely virtual. Said computer files may be stored in a mobile telephone or they may be received directly from the internet in real time by such a mobile telephone. The input of the electronic converter 7 is thus connected to a system for delivering computerized sensory information coming form a remote appliance or stored in said system.

(26) The electronic converter 7 may advantageously be made in the form of an integrated circuit and/or an electronic card including at least one microprocessor and components for converting signals from the microphone(s) 6 into signals for driving the ultrasound transducers 4. Under such circumstances, the electronic card provides intelligence for controlling the treatment system and may also host any other adjustment or control function for the treatment system 1 and its components.

(27) In particular, the treatment system 1 of the invention also includes control means for controlling the ultrasound stimulation device 3. These control and adjustment means may be provided on the above-mentioned electronic card and may comprise means for wired or wireless communication with an external control device such as a remote control interacting with the ultrasound stimulation device in order to enable the microphone(s) 6, the converter, and the transducers 4 to be switched on and off. The adjustment and control means may also include an external control device, e.g. a monitor, suitable for connection to the ultrasound stimulation device 3 through the skin P over the skull C via a transdermal connector placed in the top wall 21 of the unit 2.

(28) It is also possible to envisage controlling and adjusting the treatment system 1 by means of a mobile telephone and a computer application stored therein in a read-only memory (ROM) and serving to adjust and control the treatment system wirelessly, e.g. using the communications protocols defined by the IEEE 802.11 group (ISO/IEC 8802-11) and better known under the contraction WiFi, or by the IEEE 802.15 group, also better known under the name Bluetooth.

(29) Finally, the deafness treatment system 1 of the invention includes power supply means 8 for electrically powering the ultrasound stimulation device, the microphones, the ultrasound transducers 4, and the control means of the device. In conventional manner, these power supply means 8 may consist in rechargeable batteries arranged in the unit 2 or indeed a subcutaneous battery implanted under the skin over the skull, or indeed away from the patient's head, e.g. under the patient's skin in the chest area, as is common practice in heart surgery for implanting pacemakers. Where appropriate, such a battery can then be charged by an external charger system, such as a magnetic system.

(30) As shown in FIG. 6B, it is also possible to make provision for an emergency stop switch 9 to be located directly in the top wall 21 of the unit 2 level with the surface of the patient's skull.

(31) The treatment system 1 of the invention is preferably compatible with performing analyses by magnetic resonance imaging. That is why the unit 2, and also all of the ultrasound transducers 4, the microphone(s) 6, the converter, and the other control and power supply means are preferably made of materials that are not ferromagnetic.

(32) In a preferred embodiment of the treatment system 1 of the invention, it includes means for focusing and steering the emitted ultrasound waves U towards the target zone of the primary auditory cortex. By way of example, they may be the result of dynamic focusing or beam steering achieved by varying phase differences between emitters, by adding filters, by adding capacitors, by adding lenses, or by a combination of these means.

(33) By way of example, this may be the result of a special shape for the emission faces of the ultrasound transducers 4, in particular giving these emission faces a particular concave shape, or giving such a shape to the bottom wall 22 of the unit 2 carrying the ultrasound transducers 4.

(34) These variable focusing and steering means for the ultrasound waves U may also include means for electronically scanning one or more zones of the auditory cortex of the patient's brain B by the ultrasound waves U emitted by the ultrasound transducers.

(35) In another embodiment of the treatment system 1 of the invention as shown in FIG. 4, the treatment system 1 may include at least one additional ultrasound emitter 10 placed in the thickness of the unit 2 in order to induce and transmit bone vibration in the skull. Such an additional ultrasound emitter 10, e.g. pressed against the peripheral wall 23 of the unit 2 as shown in FIG. 4 may be found to be particularly useful in cases of transmissive deafness that may be pure or mixed with sensorineural deafness. In this embodiment, the additional ultrasound element 10 is likewise driven by the electronic converter in the unit 2.

(36) In another embodiment shown in FIG. 5B, the treatment system 1 may also include contact electrodes 11 in the bottom wall 22 of the unit 2, e.g. on either side of the ultrasound transducers 4, or even within the ultrasound emitters, in order to monitor the electrical activity of the brain and prevent any epileptic event.

(37) Under such circumstances, the electrical signal from the cortex is monitored by means of electrodes 11 connected to an electronic monitoring card inside the unit 2, and preferably incorporated in or associated with the converter in order to enable the treatment system 1 to be driven in intelligent manner. In the event of an abnormal epileptogenic signal, the ultrasound emission parameters may be stopped automatically for reasons of safety or they may be modified in order to emit an inhibiting ultrasound signal.

(38) The deafness treatment system 1 of the invention thus makes it possible to perform direct stimulation and neuromodulation of the brain activity of the primary auditory cortex of the brain B of a patient suffering from deafness by emitting ultrasound waves U that are focused and pulsed onto a very localized surface having an area of about 1 mm.sup.2 of the primary auditory cortex of the patient's brain B. Such modulation of the primary auditory cortex results from transmitting ultrasound waves U that are images of ambient sounds S sensed by the microphones 6 of the treatment system 1 and they thus make it possible to provide significant treatment for sensorineural deafness pathologies in patients suffering therefrom.

(39) The treatment system 1 of the invention also makes it possible during treatment to monitor the brain B activity of the treated patient by means of contact electrodes 11 and thus to adjust the power of the transmitted ultrasound waves U and prevent any epileptic event. The electrical activity of the brain is thus advantageously monitored continuously in the target zone of the cortex for ultrasound emission.

(40) The treatment system 1 of the invention also makes it possible to monitor the diffusion of ultrasound waves in the brain B of the treated patient before and during treatment by recording reflected ultrasound waves returned by the brain so as to determine the acoustic attenuation index of the patient's brain, in order to detect modifications, if any, to tissue structure, and in order to detect modifications, if any, in perfusion of the brain so as to modulate and adjust the intensity of the emitted waves as well as possible.

(41) The deafness treatment system of the invention provides a novel solution for treating deafness while not interfering with the somatotopy of the brains of patients, thus avoiding the drawback of presently-known treatment implants and procuring greater flexibility and accuracy of treatment without acting on the defective natural auditory apparatus of the patient.

(42) It should also be observed that a treatment system analogous to that of the invention may be envisaged for stimulating the visual cortex of the brain. Under such circumstances, the structure of the treatment system then differs from that to the system of the invention essentially in that the microphones are replaced by at least one image acquisition device, e.g. a micro-camera, that is connected to the control device in which the internal converter converts the image signal coming from the acquisition device into a signal for modulating and controlling ultrasound emitters that focus their waves onto the visual cortex of the brain.

(43) FIGS. 8 to 10 show this other preferred application of the invention to treating vision as the sensory capacity of a patient. In this application, the ultrasound stimulation device 3 has all of the technical characteristics described for the application to treating deafness, but applies to treating vision.

(44) In this application, the ultrasound stimulation device 3 has two implantable units 2.sub.1 in which the ultrasound transducers 4 are mounted. Each implantable unit 2.sub.1 is provided with a semi-rigid flap 2.sub.2 of concave shape suitable for stimulating the median visual cerebral cortex as can be seen in FIG. 7. The unit 2.sub.1 and the semi-rigid flap 2.sub.2 present an internal face 2a through which the focused ultrasound waves are emitted as generated by ultrasound transducers 4 mounted in the unit 2.sub.1 and in the semi-rigid flap 2.sub.2. Such a unit 2.sub.1 is implanted in a craniectomy hole previously formed in the patient's cranium in register with the zone of the primary visual cortex of the brain that is to be treated. The semi-rigid flap 2.sub.2 is slid between the hemispheres after the dura mater has been opened. The unit 2.sub.1 is fitted with fastener means 24 for fastening to the patient's skull.

(45) As explained with reference to FIGS. 1 to 6b, the ultrasound transducers 4 are distributed over the internal faces 2a of the implantable units in order to emit ultrasound waves that are preferably focused and at a frequency lying in the range 200 kHz to 10 MHz. The ultrasound waves are focused on a specific zone of small area of the primary visual cortex, e.g. an area of the primary visual cortex equal to about 1 mm.sup.2, in order to activate the visual cortex in highly selective manner while not interfering with the somatotopy of the brain. As explained above, ultrasound waves may be focused dynamically by electronic means for scanning one or more different zones of the visual cortex that is to be treated either simultaneously or consecutively with the emitted ultrasound waves.

(46) Furthermore, in order to adjust the power of the transmitted ultrasound waves and prevent any epileptic event, provision is made to monitor the activity of the brain continuously in the target zone of the visual cortex for ultrasound emission.

(47) The ultrasound transducers 4 are driven as explained above by the electronic converter 7 so that the focused ultrasound signals U are an image of a sensory signal, specifically a visual signal in this application. Such a visual signal is either picked up by a sensor 6.sub.1, such as an image acquisition system, or else it is generated by a computer system for delivering sensory information that is entirely virtual. In the example shown in FIG. 7, the image acquisition system 6.sub.1 has at least one camera for taking images in the environment of the patient. The camera is connected to the input of the electronic converter 7 that is suitable for decoding and processing the visual information sensed by the camera and for transforming it into control signals for controlling the ultrasound transducers 4.

(48) In an embodiment, the visual information may come directly from computer data coming from computer files without any need for a visual detector system (camera). This makes it possible in a manner that is real to the brain to deliver computerized sensory information that is entirely virtual. Said computer files may be stored in a mobile telephone or they may be received directly from the internet in real time by the mobile telephone. The electronic converter 7 thus has its input connected to a system for delivering computerized sensory information coming from a remote appliance or stored in said system.

(49) In a variant embodiment, the electronic converter 7 has means for wired or wireless communication with the ultrasound stimulation device 3, and in particular with the two implantable units 2.sub.1. For example, the camera 6.sub.1 may be incorporated in eyeglasses L that also carry the electronic converter 7.

(50) The treatment system 1 of the invention also includes means for controlling the ultrasound stimulation device 3 enabling the ultrasound stimulation device 3 to be switched on and off. As mentioned above, these control means may be implemented in various ways, e.g. with the help of an external control system connected to the ultrasound stimulation device 3 through the skin of the skull C or with the help of wireless transmission.

(51) Naturally, the vision treatment system 1 includes power supply means 8 for electrically powering the ultrasound stimulation device 3, the camera, and the electronic converter 7. In conventional manner, these power supply means 8 may consist in rechargeable batteries arranged in the units 2 or indeed they may consist in a subcutaneous battery implanted under the skin of the skull or away from the patient's head. Such a battery may also be charged by means of an external charger system such as a magnetic system.

(52) The treatment system 1 of the invention also makes it possible, during treatment, to monitor the cerebral activity of the brain B of the patient being treated by using contact electrodes 11 and thus to adjust the power of the transmitted ultrasound waves U so as to prevent any epileptic event. The electrical activity of the brain is thus advantageously monitored continuously in the target zone of the cortex for ultrasound emission.

(53) The treatment system 1 of the invention also makes it possible to monitor the diffusion of ultrasound waves in the brain B of the treated patient before and during treatment by recording reflective ultrasound waves as returned by the brain in order to determine the acoustic attenuation index of the patient's brain, in order to detect modifications, if any, to tissue structure, and in order to detect modifications, if any, in perfusion of the brain so as to modulate and adjust the intensity of the emitted waves as well as possible.