NEUROSTIMULATION SYSTEM

Abstract

The present disclosure relates to a neurostimulation system, in particular for Cortical and/or Deep Brain Stimulation, comprising:

at least one implant unit comprising:

at least one first antenna, and

at least one lead having at least one electrode array with at least one electrode; and

at least one wearable device comprising at least one second antenna,

wherein the at least one wearable device is configured to wirelessly control and wirelessly communicate with the at least one implant unit, and wherein the at least one electrode is made of reduced graphene oxide, such as hydrothermally reduced graphene oxide.

Claims

1. A neuromodulation system, in particular for Cortical and/or Deep Brain Stimulation and/or Modulation, comprising: at least one implant unit comprising: at least one first antenna, and at least one lead having at least one electrode array with at least one electrode; and at least one wearable device comprising at least one second antenna, wherein the at least one wearable device is configured to wirelessly control and wirelessly communicate with the at least one implant unit, and wherein the at least one electrode is made of reduced graphene oxide.

2. The neuromodulation system according to claim 1, wherein the implant unit further comprises a pulse generator.

3. The neurostimulation system according to claim 1, wherein the implant unit further comprises a recording system and/or sensing system to acquire signals, especially neurophysiological signals.

4. The neurostimulation system according to claim 3, wherein the wearable device is rechargeable.

5. The neurostimulation system according to claim 3, wherein the wearable device is configured to wirelessly charge or power the at least one implant unit.

6. The neurostimulation system according to claim 3, wherein the wearable device is form-fitted to a human ear.

7. The neurostimulation system according to claim 3, wherein the wearable device has a personalized and/or customized form-fit to specific ear of a human.

8. The neurostimulation system according to claim 3, wherein the wearable device comprises a device software.

9. The neurostimulation system according to claim 3, wherein the wearable device is configured to wirelessly exchange data with a mobile device and/or a data base station.

10. The neurostimulation system according to claim 7, wherein the mobile device comprises a software application configured to process data received from the wearable device and/or establish a network data link to the data base station.

11. The neurostimulation system according to claim 3, wherein the implant unit is wirelessly rechargeable.

12. The neurostimulation system according to claim 3, wherein the implant unit is anatomically fitted to an implant site and configured to be implanted cranially.

13. A method for neurostimulation, which comprises the following steps: establishing a first bidirectional wireless connection between an implant unit comprising a pulse generator and a wearable device; and transmitting pulse commands from the wearable device to the implant unit via the first bidirectional wireless connection to cause a stimulation of a target.

14. The method for neurostimulation according to claim 13, further comprising a step of transmitting signals, recorded by the implant unit, from the implant unit to the wearable device via the first bidirectional wireless connection.

15. The method for neurostimulation according to claim 13, further comprising a step of wirelessly charging the implant unit by the wearable device via the first bidirectional wireless connection.

16. The method for neurostimulation according to claim 13, further comprising at least the following steps: providing at least two implant units; establishing a bidirectional wireless connection between implant units comprising a pulse generator; and exchanging information regarding stimulation settings and/or therapy parameters and/or feedback information and/or synchronization of the stimulation pulses.

17. The method for neurostimulation according to claim 16, further comprising at least the following steps: providing at least two wearable devices; establishing a bidirectional wireless connection between wearable devices; and exchanging information regarding stimulation settings and/or therapy parameters and/or feedback information and/or synchronization of the stimulation pulses.

18. The method for neurostimulation according to claim 16, further comprising at least the following steps: establishing a bidirectional wireless connection between the wearable device, the mobile device and a second wearable device either directly and/or indirectly; and exchanging information regarding stimulation settings, therapy parameters, feedback information and synchronization of the stimulation pulses.

19. The neuromodulation system according to claim 1, wherein the reduced graphene oxide is hydrothermally reduced graphene oxide.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0091] Further details of the present disclosure shall now be disclosed in the connection with the drawings.

[0092] It is shown in

[0093] FIG. 1 a prior art neurostimulation system;

[0094] FIG. 2 an embodiment of a neuromodulation system according to the present disclosure; and

[0095] FIG. 3 the neuromodulation system of FIG. 2 attached and worn by a patient.

DETAILED DESCRIPTION

[0096] Neural implants offer therapeutic options to patients suffering from certain neurological disorders and other neural impairments (e.g. deafness, Parkinson's disease, amputations, etc.). Such technology currently consists of implantable devices that either electrically record or stimulate the nervous system using millimetre-scale metallic electrodes. To achieve broader acceptance of neural implants as a therapy, there is a need for a step-change improvement to their efficacy so that the therapeutic approach outweighs inter alia the risks from surgical implantation.

[0097] FIG. 1 shows a prior art embodiment of a neuromodulation system 10 implanted in a patient.

[0098] The embodiment of the neuromodulation system 10 shown in FIG. 1 comprises two leads 12, a pulse generator 16 and one connecting cable 14 per lead 12 to connect the leads 12 separately to the pulse generator 16.

[0099] The prior art neuromodulation system 10 needs the pulse generator 16 to be implanted in the patient's chest region, as can be derived from FIG. 1. Consequently, a follow-up surgery after first implantation of the neurostimulation system 10 is required as soon as the battery or power source of the pulse generator 16 tends to reach its end of service life.

[0100] Moreover, the connecting cables 14 must be surgically routed from the impulse generator 16 to the leads 12 during the surgical insertion. In this regard, care must be taken that the connecting cables 14 and in particular the connection between the pulse generator 16 and the leads 12 are not affected by the patient's body movements after implantation.

[0101] What is more is that generally the settings or parameters of the pulse generator 16 are set once before the implantation and it is not possible to adjust these settings after implantation. This applies in principle to the first-generation pulse generators. Modern implantable pulse generators are adjustable via a wireless connection between the pulse generator 16 and a terminal station. These terminals are often only available in a medical facility, so a patient is forced to visit a respective facility for an adjustment of the settings.

[0102] FIG. 2 shows an embodiment of a neuromodulation system 100 according to the present disclosure comprising an implant unit 110, a wearable device 130, a mobile device 150, such as a smart phone.

[0103] The neuromodulation system 100 may further comprise a data base station (not shown).

[0104] The implant unit 110 comprises a first antenna 112, a lead 114 and a pulse generator (not shown).

[0105] The first antenna 112 may be an omnidirectional antenna.

[0106] The lead 114 comprises an electrode array having at least one electrode. The lead 114 has a proximal end 116 and a distal end 118, wherein the electrode array is arranged at the distal end 118 of the lead 114.

[0107] The electrodes of the electrode array may be made of graphene, or of a hydrothermally reduced graphene oxide.

[0108] The wearable device 130 comprises a portion 132 adapted or form-fitted to the anatomy of a patient's ear and a housing 134.

[0109] The portion 132 may be made of a sufficiently flexible and adaptable material.

[0110] In particular, the core of the portion 132 may have a fixed shape.

[0111] This shape will anatomically align with the position of the implant on the body. It is possible to add a sleeve of for example silicon rubber or another soft material to optimize the comfort of wearing the device and/or fixate the position better (e.g. movement and position relative to the antenna and/or prevent detachment during daily life activities).

[0112] The housing 134 accommodates inter alia a rechargeable power source, control electronics unit and a second antenna.

[0113] The control electronic unit comprises a device software which is updatable either via a wireless connection or a port provided at the wearable device 130.

[0114] The implant unit 110 and the wearable device 130 are wirelessly connected via the first bidirectional wireless connection 120. By means of this first wireless bidirectional connection 120 control signals or commands and measured values or recorded data can be exchanged as well as power beaming, i.e. inductive coupling to charge the implant unit 110, can be conducted.

[0115] Furthermore, instead (or additionally) of an inductive coupling also ultrasound can be used to transfer and/or receive power and/or control signals and/or communication signals.

[0116] In case that wearable devices are on both sides of the head of the patient (i.e. on the left and right side), then the devices shall be able to communicate with each other. In particular, it can be realized such that there is one IPG serving for both wearable devices, and so both leads will be controlled via one IPG and via the two wearable devices. The connection can be e.g. established by using Bluetooth or NFMI (Near Field Magnetic Induction communication) or indirectly via a mobile phone, which can be a hub and coupling element.

[0117] In particular, there can be two implant units 110. A bidirectional wireless connection between implant units 110 can be established. This setup of the system is then capable to exchange information regarding stimulation settings and/or therapy parameters and/or feedback information and/or synchronization of the stimulation pulses.

[0118] Also, two wearable devices 130 can be provided. A bidirectional wireless connection between the wearable devices 130 can be established and provided. This setup of the system is capable to exchange information regarding stimulation settings and/or therapy parameters and/or feedback information and/or synchronization of the stimulation pulses.

[0119] The system can be further be capable to establish a bidirectional wireless connection between the wearable device 130, the mobile device 150 and a second wearable device 130 either directly and/or indirectly and is configured to exchange information regarding stimulation settings, therapy parameters, feedback information and synchronization of the stimulation pulses.

[0120] This way a semi-closed loop system or even a closed loop system can be established.

[0121] For reasons of setup or data processing the wearable device can further be wirelessly connected to the mobile device 150 via a second wireless bidirectional connection 140.

[0122] The second bidirectional wireless connection may be one of the group of: a 3G/4G/5G (or further generations) wireless, a WIFI network connection, a near field connection and a Bluetooth connection.

[0123] The mobile device 150 comprises a software application to process the data received from the wearable device 130 and/or to display the data.

[0124] Furthermore, it is possible to adjust the settings or parameters of the neuromodulation therapy by means of the software application. The new settings are forwarded from the mobile device 150 to the wearable device 130 via the second wireless bidirectional connection 140.

[0125] Alternatively or additionally, the mobile device 150 can establish a link to the data base station to exchange measured data of the patient or to receive optimized settings for the therapy. By forwarding the data to a data base station which may be located at a medical facility the responsible clinician can monitor the therapy without the patient having to present.

[0126] The wearable device 150 may additionally be configured to establish an individual wireless connection to the data base as a matter of redundancy.

[0127] In FIG. 3, the implant unit 110 of FIG. 1 is presented implanted in a patient's head. The first antenna 112 of the implant unit 110 is located under the scalp behind one ear, while the distal end 118 of the lead 114 reaches through the patient's cranium so that the electrode array can be brought into contact with the brain tissue.

[0128] The wearable device 130 is positioned behind the corresponding patient's ear, wherein the second antenna accommodated in the housing 134 of the wearable device 130 and the first antenna 112 of the implant unit 110 are aligned to each other.

[0129] It is possible that a patient is equipped with a combination of an implant unit 110 and a wearable device 130 at each ear so that two electrode arrays are stimulating and/or recording at the different target sites of the brain tissue.

[0130] It is also possible that one wearable device 130 controls two implanted implant units 110. In this regard, the wearable device may e.g. either comprise an additional antenna or the antennas 112 of the implant units 110 are controlled with different frequencies.

REFERENCE SIGNS

[0131] 10 prior art neurostimulation system [0132] 12 leads [0133] 14 connecting cables [0134] 16 pulse generator [0135] 100 neuromodulation system [0136] 110 implant unit [0137] 112 first antenna [0138] 114 lead [0139] 116 proximal end of the lead [0140] 118 distal end of the lead [0141] 120 first bidirectional wireless connection [0142] 130 wearable device [0143] 132 form-fitted portion [0144] 134 housing [0145] 140 second bidirectional wireless connection [0146] 150 mobile device