WO2021223702A1

WO2021223702A1 - Cranial nerve regulator

Info

Publication number: WO2021223702A1
Application number: PCT/CN2021/091856
Authority: WO
Inventors: 胥红来; 寇宇畅; 洪宇祥; 黄肖山; 刘涛; 窦莲莲; 李旭
Original assignee: 博睿康科技（常州）股份有限公司
Priority date: 2020-05-07
Filing date: 2021-05-06
Publication date: 2021-11-11

Abstract

The present invention relates to the technical field of electronic medical treatment, and provided is a cranial nerve regulator, comprising an implant (1000) and an in-vitro machine (2000). The implant (1000) comprises an implant main body (1100) and at least one electrode group (1200). The electrode group (1200) is electrically connected to the implant main body (1100) by means of an electrode wire (1300). The implant main body (1100) comprises an energy receiver (1120) and an implant main machine (1110). The in-vitro machine (2000) comprises an in-vitro machine main machine (2010) and an energy emitter (2020). The energy emitter (2020) is electrically connected to the in-vitro machine main machine (2010) by means of a connecting conductor (2030). The energy receiver (1120) is adapted to be wirelessly coupled with the energy emitter (2020) to obtain electrical energy from the in-vitro machine (2000) to power the implant main machine (1110), and the implant main machine (1110) is adapted to be in wireless communication connection to the in-vitro machine main machine (2010). During use, the main body part of the implant (1000) is implanted under the cortex of the rear part of the ear of the user, and an electrode is led to a diseased region in a subcutaneous penetration manner. Therefore, the electrode wire is shorter, and the receiving of interference signals is reduced. The electrode is a cortex electrode, is placed between dura mater and bones, and does not damage brain tissue. Power is supplied by means of magnetic coupling without affecting signal transmission and signal acquisition.

Description

Neuroregulator

Cross-references to related applications

This application claims the priority of the Chinese invention patent application No. 202010376321.7 filed on May 7, 2020 and the Chinese utility model patent application No. 202020730485.0 filed on May 7, 2020. The entire content of the patent application is incorporated herein by reference.

Technical field

The present invention relates to the field of electronic medical technology, in particular to a brain neuromodulator.

Background technique

Implantable cranial nerve regulators are used for cranial nerve signal acquisition and treatment, and are widely used in the treatment of chronic diseases such as Parkinson's, dystonia, essential tremor, epilepsy and so on. In the prior art, as shown in FIG. 1, an implantable cranial neuromodulator usually includes an implant 1 and an electrode 2. The implant 1 is usually placed under the skin of the chest wall, and the electrode 2 is implanted in the brain. The implant 1 is connected to an electrode 2 through a subcutaneous wire 3, and the electrode 2 collects physiological electrical signals from the target nucleus 4 and outputs electrical stimulation signals.

However, the existing cranial nerve adjustment devices implanted in the chest wall/abdominal wall have the following problems:

1. Skin ulcer infection caused by implants or connecting wires: It is more likely to occur in elderly patients or patients with thinner skin and poor elasticity. Moreover, once infection occurs, debridement, deep embedding, and antibiotic application are usually ineffective, and only the implant can be removed.

2. The electrode wire is easy to break: most of the breakage occurs behind the ear, especially at the interface between the intracranial electrode and the extension wire.

3. Connecting wires to introduce interference signals: For feedback-type implanted cranial nerve modulation equipment, cranial nerve signals need to be collected, and too long wires will introduce more interference signals.

4. Short life: using built-in battery, short life, does not support large amount of data and long-term data transmission.

Summary of the invention

The embodiment of the present invention provides a brain neuromodulator, which is suitable for being directly implanted into the cerebral cortex and wirelessly powered to solve some or all of the above technical problems in the prior art.

The brain neuromodulator provided by the embodiments of the present invention may include an implant and an external machine that communicates with the implant through wireless communication;

The implant includes an implant body suitable for implanting into the cortex of the back of the user's ear and at least one electrode group suitable for implanting into the cerebral cortex of any target part of the user, and the electrode group is connected to the implant via an electrode wire. The main body of the implant is electrically connected, and the main body of the implant includes an energy receiver and the main body of the implant;

The extracorporeal machine includes an extracorporeal machine host and an energy transmitter, and the energy transmitter is electrically connected to the extracorporeal machine host through a connecting wire;

Wherein, the energy receiver is adapted to be wirelessly coupled with the energy transmitter to obtain electrical energy for powering the implant host from the external machine.

Wherein, the electrode group may include stimulation electrodes for outputting stimulation signals and collection electrodes for collecting physiological electrical signals. The number of electrodes is not limited in the present invention, and can be set arbitrarily according to requirements.

In an embodiment of the present invention, the implant host includes the following circuit modules:

The implant receiving power supply unit is electrically connected to the energy receiver to convert the energy received by the energy receiver from the energy transmitter into a power supply voltage suitable for the implant host;

A stimulation unit, electrically connected to the stimulation electrode, for generating the stimulation signal;

An acquisition unit, electrically connected to the acquisition electrode, for receiving the physiological electrical signal;

The external machine communication unit is adapted to receive control instructions sent by the external machine or send data to the external machine through the wireless communication method;

The implant control unit is used to control the respective operations of the implant receiving power supply unit, the stimulation unit, the acquisition unit, and the external machine communication unit.

Wherein, the external machine host may include:

An external machine power supply unit for supplying power to the external machine;

The power supply unit for the implant is electrically connected with the energy transmitter to wirelessly transmit electric energy to the energy receiver of the implant through the energy transmitter;

For the implant communication unit, it is suitable for sending control instructions to the implant or receiving data sent by the implant via wireless communication;

Storage unit, used to store various data and programs;

The extracorporeal machine control unit is used to control the respective operations of the extracorporeal machine power supply unit, the implant power supply unit, the implant communication unit, and the storage unit.

Optionally, the extracorporeal machine host may further include: a communication unit for external devices adapted to communicate with other devices through wired or wireless communication.

In the embodiment of the present invention, the wireless communication method may include Bluetooth and near field communication.

In some embodiments of the present invention, the energy transmitter includes an extracorporeal resonant coil, and the energy receiver includes an intracorporeal resonant coil.

In another embodiment of the present invention, the external machine host may include: a power amplifier, an external machine modulation module, an external machine demodulation module, an external machine DC/DC module, and an external machine microcontroller. The extracorporeal machine modulation module converts the information generated by the extracorporeal machine microcontroller into a digital signal waveform and sends it to the power amplifier; the extracorporeal machine DC/DC module converts the DC voltage provided by the external machine's power supply Is a power supply voltage suitable for the implant and sent to the power amplifier; the power amplifier converts the digital signal waveform and the power supply voltage suitable for the implant into a radio frequency waveform and passes the external resonance The coupling of the coil and the internal resonant coil is transmitted to the implant; the external machine demodulation module converts the radio frequency wave on the external resonant coil containing the information sent back by the implant into a digital signal and Send to the external machine microcontroller.

Wherein, the implant host may include: an implant modulation module, an implant demodulation module, an AC/DC module, an implant DC/DC module, and an implant microcontroller. The AC/DC module converts the radio frequency waveform on the internal resonance coil into a direct current voltage, and the implant DC/DC module converts the direct current voltage into a direct current supply voltage suitable for powering the implant host The implant demodulation module converts the radio frequency waveform containing the information sent by the external machine on the internal resonance coil into a digital signal waveform and sends it to the implant control unit; the implant modulates The module changes the resonance state of the internal resonant coil according to the digital signal generated by the implant microcontroller to generate the radio frequency waveform containing the information sent back by the implant on the external resonant coil.

In some embodiments of the present invention, the main body of the extracorporeal machine is provided with a connecting member suitable for fixing to the user's arm or neck or waist belt.

Using the brain stimulation regulator provided by each embodiment of the present invention can achieve the following beneficial effects:

1. The main body of the implant is implanted under the cortex of the back of the user's ear, and the electrode is guided to the lesion under the skin. The length of the electrode wire is greatly shortened compared with the prior art solution, which reduces the reception of interference signals. At the same time, the main body of the implant is located on the head of the user, and there is no relative movement between the main body of the implant and the electrode caused by the movement of the user’s neck. The probability of breaking is greatly reduced, and motion noise will not be introduced.

2. Compared with the prior art, the path damage caused by the arrangement of the electrode wire is greatly shortened, which is beneficial to the surgical operation and the rehabilitation of the patient.

3. The main body of the implant is implanted under the cortex of the back of the user's ear, without the need for an incision in the chest. The skull at the back of the ear has a smooth shape and a certain thickness, which is suitable for grinding bone to cut a groove for placing part of the pulse stimulator. After the operation, the main part of the implant body is flush with the outer surface of the skull without protrusions, and the skin is restored and sutured smoothly without protrusions and without force, which reduces the possibility of infection and rupture. After the incision is restored, the hair will be covered, and the appearance will not be affected.

4. Reduce or replace the internal battery of the implant through wireless charging, while supporting higher internal circuit power consumption to achieve more complex circuit functions and wireless communication functions. The service life of the device is greatly extended, and there is no failure caused by the exhaustion of the built-in battery.

5. Each electrode group contains several collection electrodes and stimulation electrodes. By placing different electrode groups in different positions of the cortex, multi-point collection and stimulation can be realized, or multiple groups can be used at the same time to realize complex EEG collection and stimulation electrodes Configuration mode.

6. The electrode is a cortical electrode (not a deep electrode), and the electrode is placed between the dura mater and the bone, which will not cause damage to the brain tissue.

7. The energy transmitter and the energy receiver are wirelessly coupled for only energy transmission, which has higher transmission efficiency and does not affect signal transmission and signal acquisition.

8. The extracorporeal machine and the implant use Bluetooth communication, which has a long transmission distance and stable signal transmission, which is not susceptible to interference.

Description of the drawings

Fig. 1 is a schematic diagram of the application of the existing cranial nerve regulator.

Fig. 2 is a schematic diagram of the application of a brain neuromodulator according to an exemplary embodiment of the present invention.

Fig. 3 is a schematic diagram of an implant of a cranial nerve regulator according to an exemplary embodiment of the present invention.

Fig. 4 is a partial cross-sectional view of an implant of a cranial nerve regulator according to an exemplary embodiment of the present invention.

Fig. 5 is a schematic diagram of an extracorporeal machine of a brain neuromodulator according to an exemplary embodiment of the present invention.

Fig. 6 is a circuit block diagram of a brain neuromodulator according to an exemplary embodiment of the present invention.

Fig. 7 is a schematic diagram of cortical electrode implantation according to an exemplary embodiment of the present invention.

Fig. 8 is a circuit block diagram of a brain neuromodulator according to another embodiment of the present invention.

Detailed ways

The various aspects of the present invention will be described in detail below with reference to the drawings and specific embodiments. Among them, well-known components, modules, units and their mutual connections, links, communications or operations are not shown or detailed. And, the described features, structures or functions can be combined in any manner in one or more embodiments. Those skilled in the art should understand that the following various embodiments are only used for exemplification, and are not used to limit the protection scope of the present invention. It can also be easily understood that the modules or units or processing methods in the various embodiments described herein and shown in the drawings can be combined and designed in various different configurations.

Fig. 2 shows an exemplary application scenario of the brain neuromodulator provided by the present invention. In an exemplary embodiment of the present invention, the brain neuromodulator includes an implant body 1000 and an extracorporeal machine 2000. Wherein, unlike the prior art implant 1 shown in FIG. 1, which is usually placed under the skin of the chest wall, the implant 1000 of this embodiment is suitable for implanting in the cerebral cortex of a user, that is, the patient's cerebral cortex, while the extracorporeal machine 2000 is placed outside the user's body. .

In an exemplary embodiment of the present invention, as shown in FIG. 3, the implant 1000 includes an implant body 1100 adapted to be implanted into the back cortex of a user's ear, and at least one implant body 1100 suitable for implantation in any target part of the user The electrode group of the cerebral cortex is 1200. In the exemplary embodiment, the implant 1000 includes two electrode groups 1200. The present invention does not limit this. According to the physiological condition of the patient, one electrode group can be set, or more than three electrode groups can be implanted in different positions of the cortex. The electrode group 1200 may include stimulation electrodes 1201 for outputting stimulation signals and collection electrodes 1202 for collecting physiological electrical signals. The electrode group 1200 is electrically connected to the implant body 1100 through an electrode wire 1300, and the implant body includes an energy receiver 1120 and an implant body 1110.

In an exemplary embodiment of the present invention, as shown in FIGS. 2 and 5, the external machine 2000 includes an external machine host 2010 and an energy transmitter 2020, and the energy transmitter 2020 is connected to the external machine through a connecting wire 2030. The host 2010 is electrically connected.

Wherein, the energy receiver 1120 can be wirelessly coupled with the energy transmitter 2020 to obtain electrical energy from the extracorporeal machine 2000 to power the implant host 1110, and the implant host 1110 can communicate with the implant host 1110. External machine host 2010 wireless communication connection.

In an exemplary embodiment of the present invention, as shown in FIG. 4, the implant body 1110, the energy receiver 1120, the electrode wire 1300, and the electrode group 1200 are made of silicone 1400 that meets the biocompatibility requirements of the implant. Cover, and each electrode end of the electrode group 1200 is exposed from the silica gel 1400.

The implant main body 1110 includes a bottom shell 1111, a protective cover 1112, an implant circuit board 1113, a feeder plate 1114, and an antenna 1115 (that is, an internal antenna implanted in the body during use). Wherein, the bottom shell 1111 and the protective cover 1112 are combined and define a space for accommodating the implant circuit board 1113 and the feeder plate 1114, the antenna 1115 is arranged outside the bottom shell 1111, and the implant The body-in circuit board 1113 is combined with the feeding plate 1114 to be electrically connected to the energy receiver 1120, the electrode group 1200 and the antenna 1115 through the feeding plate 1114. Wherein, the bottom shell 1111, the protective cover 1112, the implant circuit board 1113, the power feeding plate 1114, and the antenna 1115 are entirely covered by silica gel 1400.

The energy receiver 1120 includes a magnet 1121 (ie, an in-vivo magnet implanted in the body when in use) and an in-body resonant coil 1122, wherein the magnet 1121 is located in the housing 1123 and is surrounded by the in-body resonant coil 1122. The housing 1123, the magnet 1121, and the internal resonant coil 1122 are entirely covered by silica gel 1400 and connected with the implant main body 1110 to form an implant main body 1100 as a whole. Correspondingly, as shown in FIG. 5, the energy transmitter 2020 of the extracorporeal machine 2000 includes a housing 2023, a magnet 2021 (that is, a magnet located outside the body during use), and an extracorporeal resonance coil 2022 surrounding the magnet 2021. The magnet 2021 and the external resonance coil 2022 are located in the housing 2023. As shown in FIG. 2, the magnet 1121 and the magnet 2021 are attracted to each other to adsorb and fix the energy transmitter 2020 and the energy receiver 1120. The external resonant coil 2022 converts the supply voltage into electromagnetic radiation and emits it. The internal resonant coil 1122 receives the electromagnetic radiation and converts it into a supply voltage for the implant 1000. In the embodiment of the present invention, the energy transmitter and the energy receiver are wirelessly coupled to only perform energy transmission, which has higher transmission efficiency and does not affect signal transmission and signal acquisition.

The electrode wire 1300 is formed by wrapping a metal wire 1301 with silica gel 1400, and is connected to the main body 1110 of the implant as a whole. The electrode wire 1300 is used to electrically connect the electrode group 1200 and the implant body host 1110 to transmit stimulation signals and collect data. Wherein, the electrode group 1200 is formed into a sheet-like or flat-shaped member by covering each electrode with silica gel 1400, and is integrated with the electrode wire 1300, on which the motor end portion is exposed from the silica gel 1400. In an exemplary embodiment of the present invention, on the strip-shaped sheet member, that is, the electrode group 1200, two stimulation electrodes 1201 are close to both ends, and three collection electrodes 1202 are located between the two stimulation electrodes 1201. In an alternative embodiment of the present invention, each electrode group can be set with or without collection electrodes according to the needs of the patient's physiological condition, and the number of stimulation electrodes and collection electrodes can also be set according to needs. As shown in FIG. 7, the electrode 1200 is a cortical electrode (not a deep electrode), as shown in the wound 3000, it is placed between the dura mater and the bone and will not cause damage to the brain tissue.

In the exemplary embodiment of the present invention, the implant body 1100 and the electrode 1200 are formed into an integral structure by the silicone 1400, which reduces the risk of unreliability caused by the plug connection.

In an exemplary embodiment of the present invention, for the implant 1100 covered by the silicone, as shown in FIG. 4, the thickness of the part where the main body 1110 of the implant is located is greater than the part where the energy receiver 1120 is located. The part where the energy receiver 1120 is located is bent at a predetermined angle with respect to the part where the implant body 110 is located, and the predetermined angle is set so that the implant body 1100 fits the shape of the skull behind the human ear the size of.

In an exemplary embodiment of the present invention, for the implant 1100 covered by the silicone, the silicone 1400 of the part where the energy receiver 1120 is located has an opening for removing and installing the internal magnet, so that the magnet 1121 can The silica gel 1400 is embedded and can be taken out from the silica gel 1400.

In an exemplary embodiment of the present invention, the external machine host includes a housing, an external antenna (that is, an antenna located outside the body of the user when in use), and an external machine circuit board, and the external machine circuit board is located in the housing The external antenna may be arranged inside or outside the housing, that is, it may be an internal antenna or an external antenna. As shown in FIG. 5, the external machine host 2010 is connected to the energy transmitter 2020 through a connecting wire 2030. Wherein, the connecting wire 2030 and the external machine host 2010 are connected in a plug-in type, that is, a jack is provided on the outer shell of the external machine host 2010, and the connecting wire 2030 has a plug, which is realized by inserting the plug into the jack. The connection between the connecting wire and the external machine host. The energy transmitter 2020 includes a housing 2023, a magnet 2021, and an external resonance coil 2022 surrounding the magnet 2021, and the magnet 2021 and the external resonance coil 2022 are located in the housing 2023. As shown in FIG. 2, the magnet 2021 and the magnet 1121 are attracted to each other to fix the energy transmitter 2020 and the energy receiver 1120 by adsorption. The external resonant coil 2022 converts the supply voltage into electromagnetic radiation and emits it. The internal resonant coil 1122 receives the electromagnetic radiation and converts it into a supply voltage for the implant 1000. In an alternative embodiment, one of the magnet 2021 and the magnet 1121 is a magnet, and the other may be a component that can attract each other with the magnet. In an optional embodiment, one of the magnet 2021 and the magnet 1121 is a magnet, and the other is a magnet with an opposite polarity. In other optional embodiments, one or both of the magnet 2021 and the magnet 1121 may be omitted, and a soft band is used to fix the energy transmitter in a position aligned with the energy receiver.

In an exemplary embodiment of the present invention, as shown in FIG. 6, the circuit structure of the implant host 1110 may include the following circuit modules:

The implant receiving power supply unit 1001 is electrically connected to the energy receiver 1120 to convert the energy received by the energy receiver 1120 from the energy transmitter 2020 into a power supply voltage suitable for the implant host 1110;

The stimulation unit 1002, which is electrically connected to the stimulation electrode 1201, is used to generate stimulation signals;

The collection unit 1003 is electrically connected to the collection electrode 1202, and is configured to receive the physiological electrical signals sensed by the collection electrode 1202;

The external machine communication unit 1004 is electrically connected to the antenna 1115, and is adapted to receive control instructions sent by the external machine 2000 or send data to the external machine 2000 through the antenna 115;

The control unit 1005 (ie, the implant control unit) is used to control the respective operations of the implant receiving power unit 1001, the stimulation unit 1002, the acquisition unit 1003, and the external machine communication unit 1004.

In an exemplary embodiment of the present invention, the control unit 1005 of the implant is responsible for controlling the system functions of the entire implant, and communicates with the extracorporeal machine 2000 through the extracorporeal machine communication unit 1004. The control unit 1005 can receive a control instruction of the extracorporeal machine 2000 to control the acquisition unit 1003 and the stimulation unit 1002. The control unit 1005 may also analyze the collected data through an algorithm, and actively initiate stimulation through the stimulation unit 1002 according to the analysis result. In an exemplary embodiment of the present invention, the control unit 1005 may be realized by a single-chip microcomputer or the like.

In an optional embodiment of the present invention, the implant host 1110 may further include a secondary battery that stores the electrical energy received by the energy receiver, for example, a lithium ion battery.

In an exemplary embodiment of the present invention, part or all of the implant receiving power supply unit 1001, the stimulation unit 1002, the acquisition unit 1003, the external communication unit 1004, and the control unit 1005 are arranged on the implant circuit board. 1113 on.

In an exemplary embodiment of the present invention, as shown in FIG. 6, the external machine host 2010 may include the following circuit modules:

The external machine power supply unit 2001 is used to supply power to the external machine, and can be powered by a battery or USB;

The implant power supply unit 2002 is electrically connected to the energy transmitter 2020 to wirelessly transmit electric energy to the energy receiver 1120 of the implant 1000 through the energy transmitter 2020;

The implant communication unit 2003 is electrically connected to the external antenna, and is adapted to send control instructions to the implant 1000 or receive data sent by the implant 1000 through the external antenna;

The storage unit 2004 is used to store various data;

The control unit 2005 (ie, the external machine control unit) is used to control the respective operations of the external machine power supply unit 2001, the implant power supply unit 2002, the implant communication unit 2003, and the storage unit 2004.

In an alternative embodiment of the present invention, the external machine host further includes an external device communication unit 2006 adapted to communicate with other devices through wired or wireless communication.

In an exemplary embodiment of the present invention, the extracorporeal machine control unit is used to control the operation of the entire extracorporeal machine system. For example, receiving instructions from external devices, sending instructions to implants, receiving and processing data sent by implants, controlling whether to start/cut power supply to implants, etc. In an exemplary embodiment of the present invention, the control unit 2005 may be realized by a single-chip microcomputer or the like.

In an exemplary embodiment of the present invention, the implant 1000 and the extracorporeal machine 2000 and/or the extracorporeal machine 2000 and other external devices communicate via Bluetooth. Bluetooth has a long transmission distance and stable signal transmission, which is not susceptible to interference. In an alternative embodiment of the present invention, NFC (Near Field Communication) may also be used for communication between the devices.

In the exemplary embodiment of the present invention, the external machine power supply unit 2001, the implant power supply unit 2002, the implant communication unit 2003, the storage unit 2004, the control unit 2005, and the external device communication unit 2006 are part of or All are arranged on the circuit board of the extracorporeal machine.

In some embodiments of the present invention, the external machine main body may have a connecting part suitable for fixing with the user's arm or neck or waist belt, for example, a strap, a lanyard, a clip, and the like.

In some embodiments of the present invention, the external machine host may have a power indicator.

In some embodiments of the present invention, the external machine host may have an alarm adapted to give an alarm when the external machine is disconnected from the internal machine. For example, when the external machine control unit detects that the energy transmitter is disconnected from the energy receiver or the wireless communication connection is disconnected, an alarm will be triggered.

In some embodiments of the present invention, a debugging interface is provided on the external machine host.

In some embodiments of the present invention, the external machine power supply unit 2001 includes a secondary battery, for example, a lithium ion battery.

The implant body of the embodiment of the present invention is implanted under the skin of the back of the user's ear, and is closely attached to the skull. The skull at the back of the ear has a smooth shape and a certain thickness, which is suitable for grinding the bone to cut a groove for the part of the cranial nerve regulator. After the operation, the main body of the implant is flush with the outer surface of the skull without protrusions, and the skin is restored and sutured smoothly without protrusions. After the incision is restored, there will be hair covering, which does not affect the appearance. The electrodes are placed in close contact with the appropriate areas of the cerebral cortex in the user's cranium. The energy transmitter (external resonant coil) of the extracorporeal machine is magnetically attached to the user's head, aligned and coupled with the energy receiver (internal resonant coil), and the extracorporeal machine powers the implant through the extracorporeal resonant coil.

Figure 8 shows another embodiment of the present invention. As shown in Fig. 8, in this embodiment, similar to Fig. 2, the cranial nerve regulator includes an external machine and an implant. The difference from the foregoing exemplary embodiment is that the extracorporeal machine and the implant are magnetically coupled with a resonant coil for power supply and communication. In other words, in this embodiment, the wireless communication method is a radio frequency communication method. The differences are described in detail below, and other identical or similar components and processing will not be repeated.

In this embodiment, the extracorporeal machine includes an extracorporeal machine host and a resonant coil 816 (ie, an extracorporeal resonant coil), wherein the resonant coil 816 and the extracorporeal resonant coil 2022 may have the same configuration. The external machine host may include: MCU 811 (i.e. external machine microcontroller), adjustable DC/DC812 (i.e. external machine DC/DC module), Class E (Class E) power amplifier 813, modulation module 814 (i.e. external Machine modulation module), and a demodulation module 815 (that is, an external machine demodulation module).

The implant includes an implant main body and a resonant coil 826 (ie, an internal resonant coil), wherein the resonant coil 826 and the external resonant coil 1122 may have the same configuration. The implant host may include: MCU 821 (i.e. implant microcontroller), implant AC/DC 822, implant DC/DC 823, modulation module 824 (i.e. implant modulation module), and Demodulation module 825 (ie implant demodulation module).

On the one hand, in the external machine, the MCU 811 is responsible for generating the information to be sent (for example, stimulation instructions), and the modulation module 814 converts the information to be sent into the corresponding digital signal waveform and sends it to the Class E power amplifier 813, Class The E power amplifier converts the digital signal waveform into a corresponding radio frequency waveform. For example, the modulation module 814 generates a drive signal of the power amplifier according to the digital signal waveform, so that the power amplifier outputs the modulated radio frequency waveform, which passes through the resonant coil 816 and the resonant coil The 826 wireless coupling (specifically, magnetic coupling) is transmitted to the implant demodulation module 825. In addition, the adjustable DC/DC 812 can generate an adjustable DC voltage according to the power supply of the external machine. This voltage is directly supplied to the Class E power amplifier 813. By outputting different voltages, the Class E power amplifier 813 can output radio frequency waveforms of different amplitudes. To the resonant coil 816, electric energy is sent to the implant through the magnetic coupling between the resonant coil 816 and the resonant coil 826. Thus, the power amplifier can generate a radio frequency waveform containing the information sent by the external machine to the implant, and transmit it to the resonant coil 826 through magnetic coupling.

In the implant, on the one hand, the RF waveform on the resonant coil 826 is converted into a DC voltage through the implant AC/DC 822, and the implant DC/DC 823 is converted into a DC voltage suitable for other circuits of the implant. . On the other hand, the demodulation module 825 demodulates the radio frequency waveform on the resonant coil 826 to obtain a digital signal waveform, and transmits the digital signal waveform to the MCU 821 for calculation and processing to obtain corresponding information, such as stimulation instructions. Thus, information transmission and power supply are realized through magnetic coupling.

On the other hand, in the implant, the modulation module 824 sends the information that the implant needs to send back to the external machine (for example, the collected data obtained through the collection electrode, which is sent to the modulation module 824 through the MCU 821), after being modulated, passes through The magnetic coupling between the resonant coil 826 and the resonant coil 816 is transmitted to the demodulation module 815 of the external machine. For example, the modulation module 824 changes the resonance state (for example, the resonant frequency) of the resonant coil 826 according to the digital signal waveform output by the MCU 821, so that the The radio frequency waveform generated on the resonant coil 816 contains the information that the implant needs to send back to the external machine. The demodulation module 815 demodulates the radio frequency waveform to obtain a digital signal waveform that can be recognized by the MCU 811, and the digital signal waveform is processed by the MCU to obtain corresponding information and send it to the MCU 811.

The brain neuromodulator according to the embodiment of the present invention realizes energy transmission and information (including stimulation instructions and collected data) transmission through the magnetic coupling of the resonant coil, so that the circuit configuration of the implant is compared with the additional wireless communication Transmission is more simplified. Moreover, since only magnetic coupling is performed through the resonant coil, there is no ionization signal, so that the transmission is more stable (less affected by the surrounding environment, especially in the human environment such as muscles and physiological saline).

The various aspects of the present invention have been described in detail above through various embodiments. Those skilled in the art should understand that what is disclosed above is only the embodiments of the present invention, and of course the scope of rights of the present invention cannot be limited by this. Equivalent changes made according to the embodiments of the present invention are still covered by the claims of the present invention. Scope.

Claims

A cranial nerve regulator, which is characterized by comprising an implant and an external machine communicating with the implant through wireless communication;

The implant includes an implant body suitable for implanting into the cortex of the back of the user's ear and at least one electrode group suitable for implanting into the cerebral cortex of any target part of the user, and the electrode group is connected to the implant via an electrode wire. The main body of the implant is electrically connected, and the main body of the implant includes an energy receiver and the main body of the implant;

The extracorporeal machine includes an extracorporeal machine host and an energy transmitter, and the energy transmitter is electrically connected to the extracorporeal machine host through a connecting wire;

Wherein, the energy receiver is adapted to be wirelessly coupled with the energy transmitter to obtain electrical energy for powering the implant host from the external machine.
The brain neuromodulator according to claim 1, wherein the electrode group includes stimulation electrodes for outputting stimulation signals and collection electrodes for collecting physiological electrical signals.
The cranial nerve regulator of claim 2, wherein the implant host includes the following circuit modules:

The implant receiving power supply unit is electrically connected to the energy receiver to convert the energy received by the energy receiver from the energy transmitter into a power supply voltage suitable for the implant host;

A stimulation unit, electrically connected to the stimulation electrode, for generating the stimulation signal;

An acquisition unit, electrically connected to the acquisition electrode, for receiving the physiological electrical signal;

The external machine communication unit is adapted to receive control instructions sent by the external machine or send data to the external machine through the wireless communication method;

The implant control unit is used to control the respective operations of the implant receiving power supply unit, the stimulation unit, the acquisition unit, and the external machine communication unit.
The cranial nerve regulator of claim 3, wherein the external machine host comprises:

An external machine power supply unit for supplying power to the external machine;

The power supply unit for the implant is electrically connected with the energy transmitter to wirelessly transmit electric energy to the energy receiver of the implant through the energy transmitter;

For the implant communication unit, it is suitable for sending control instructions to the implant or receiving data sent by the implant via wireless communication;

Storage unit, used to store various data;

The extracorporeal machine control unit is used to control the respective operations of the extracorporeal machine power supply unit, the implant power supply unit, the implant communication unit, and the storage unit.
The brain neuromodulator according to claim 4, wherein the external machine host further comprises: a communication unit with external equipment adapted to communicate with other equipment through wired or wireless communication.
The brain neuromodulator according to claim 1, wherein the wireless communication method includes Bluetooth and near field communication.
The brain neuromodulator according to claim 1, wherein the energy transmitter comprises an external resonance coil, and the energy receiver comprises an internal resonance coil.
8. The brain neuromodulator of claim 7, wherein the external machine host comprises: a power amplifier, an external machine modulation module, an external machine demodulation module, an external machine DC/DC module, and an external machine microcontroller;

The extracorporeal machine modulation module converts the information generated by the extracorporeal machine microcontroller into a digital signal waveform and sends it to the power amplifier;

The DC/DC module of the external machine converts the DC voltage provided by the power supply of the external machine into a power supply voltage suitable for the implant and supplies it to the power amplifier;

The power amplifier converts the digital signal waveform and the power supply voltage suitable for the implant into a radio frequency waveform and transmits it to the implant through the wireless coupling of the external resonant coil and the internal resonant coil;

The extracorporeal machine demodulation module converts the radio frequency wave on the extracorporeal resonance coil containing the information sent back by the implant into a digital signal waveform and sends it to the extracorporeal machine microcontroller.
The neuromodulator of claim 8, wherein the implant host includes: an implant modulation module, an implant demodulation module, an AC/DC module, an implant DC/DC module, and Implant microcontroller;

The AC/DC module converts the radio frequency waveform on the internal resonant coil into a direct current voltage, and the implant DC/DC module converts the direct current voltage into a direct current supply voltage suitable for powering the implant host ；

The implant demodulation module converts the radio frequency waveform on the internal resonance coil containing the information sent by the external machine into a digital signal waveform and sends it to the implant control unit;

The implant modulation module changes the resonance state of the internal resonant coil according to the waveform of the digital signal generated by the implant microcontroller, and generates the information including the information sent back by the implant on the external resonant coil的RF waveform.
The cranial nerve regulator according to claim 1, wherein the main body of the external machine is provided with a connecting member suitable for fixing with the arm, neck or waist belt of the user.