Capacitive coupled energy transfer neurostimulation system and its in-vivo neurostimulator and ex-vivo energy controller

Abstract

A capacitive coupling energy transmission nerve electric stimulation system, an in-vivo nerve electric stimulator and an out-vivo energy controller thereof. The capacitive coupling energy transmission nerve electric stimulation system comprises an in-vivo nerve electric stimulator and an out-vivo energy controller, and can further comprise a program controller with an APP of an upper computer control. The in-vivo nerve electric stimulator comprises at least one stimulator coupling capacitor plate, a stimulator compensation resonant network, a rectifier circuit, a filter capacitor, a main control chip, a stimulator harmonic communication module, multiple groups of stimulation electrodes and corresponding balance capacitors. The stimulator coupling capacitor plate is coupled with an energy controller coupling capacitor plate of the out-vivo energy controller, thereby receiving electric energy from the out-vivo energy controller and realizing information exchange. The capacitive coupling energy transmission nerve electric stimulation system can improve the transmitted electric power.

Description

TECHNICAL FIELD

[0001] The present application relates to a transcutaneous non-contact energy transmission system for nerve electrical stimulation. BACKGROUND

[0002] Transcutaneous energy transmission system (TETS) is different from implantable battery power supply, which is a kind of energy source placed outside the body, through the magnetic field and electromagnetic induction to transmit to the implanted device in the body through the skin. According to the different working frequency and power level, the transcutaneous energy transmission method currently applied to the implanted device of human body can be divided into two types: radio frequency energy transmission and TETS based on non-contact transformer.

[0003] The external radio frequency power supply technology is widely used in human body implanted device energy and data transmission, which provides power from outside to inside by electromagnetic induction and magnetic field coupling of radio frequency, or directly supplies power to the internal circuit, or charges the rechargeable battery in the body. In recent years, due to the increasing complexity of the electronic system implanted in the body, the power consumption of the internal electronic system is also increasing. Due to the limitation of its own topology, the radio frequency power supply technology cannot realize the power supply of large power implanted devices such as artificial heart.

[0004] For example, Chinese patent CN103796715B discloses a nerve stimulator system, which uses an external controller to send electric energy to the implanted part in the body through a radio frequency antenna. Due to the above limitations, the transmission distance of this system is short (<6cm), and the transmission power is limited by the battery capacity of the external controller.

[0005] To solve the above problems, transcutaneous energy transmission using non-contact transformer is increasing. Similar to the principle of radio frequency energy transmission, both of them use electromagnetic induction principle to realize electromagnetic, magnetic-electric conversion and non-contact transmission of energy. The difference is that this new type of inductive energy transmission uses a non-contact transformer with large primary and secondary air gaps as the key link of energy transmission, the secondary side of the transformer is implanted in the body, the primary side of the transformer is opposite to the secondary side, located outside the body, and the electric energy is transmitted to the implanted device in the body through electromagnetic induction in the form of magnetic field. Compared with the above radio frequency energy transmission, the working frequency of this system is relatively low. Because the split transformer has a large leakage inductance, the energy transmission efficiency of this system is adversely affected.

[0006] The information disclosed in the background section of this application is only intended to increase the understanding of the overall background of the application, and should not be regarded as acknowledging or implying in any form that this information constitutes prior art known to those skilled in the art. SUMMARY

[0007] The application aims to provide an implantable neuro-electric stimulator system based on capacitive coupling for electric energy transmission. Compared with the implantable neuro-electric stimulator system based on radio frequency transmission or transformer transmission, the capacitive coupling electric energy transmission of the application can transmit higher electric power.

[0008] The application provides an in-vivo neuro-electric stimulator, comprising: at least one stimulator coupling capacitor plate for coupling with an energy controller coupling capacitor plate of an external energy controller, so as to receive electric energy from the external energy controller and realize information exchange; a stimulator compensation resonance network connected to the stimulator coupling capacitor plate, so as to compensate for the reactive power in the received electric energy; a rectifier circuit connected to the stimulator compensation resonance network, for converting the compensated alternating current electric energy into direct current electric energy; a filter capacitor connected to the rectifier circuit, for direct current filtering of the rectified direct current electric energy; a master control chip for controlling the operation of the in-vivo neuro-electric stimulator, connected to the rectifier circuit and the filter capacitor and powered thereby; a stimulator harmonic communication module connected between the stimulator coupling capacitor plate and the master control chip, for modulating and demodulating communication information; and a plurality of sets of stimulating electrodes and corresponding balancing capacitors, wherein each balancing capacitor is connected between the master control chip and the corresponding stimulating electrode, receives a stimulating pulse from the master control chip and applies the stimulating pulse to the corresponding stimulating electrode, and realizes charge balance.

[0009] In the in-vivo neuro-electric stimulator, preferably, two stimulator coupling capacitor plates are included, wherein the stimulator compensation resonance network is configured in such a manner that one of the two stimulator coupling capacitor plates is connected to the rectifier circuit through a stimulator compensation inductor, and the other of the two stimulator coupling capacitor plates is directly connected to the rectifier circuit.

[0010] In the in-vivo neuro-electric stimulator, preferably, the stimulator harmonic communication module comprises a filter circuit sensitive to A-th harmonic, so as to extract information from the A-th harmonic in the received signal and transmit the information to the master control chip. Further preferably, the stimulator harmonic communication module further comprises a filter circuit sensitive to B-th harmonic, so as to extract the B-th harmonic from the received signal, and the master control chip controls the impedance modulation of the B-th harmonic by the stimulator harmonic communication module, and the impedance-modulated data is transmitted to the external energy controller by the stimulator coupling capacitor plate. Alternatively, B can be equal to A.

[0011] The application also provides an external energy controller for transmitting electric energy to an internal nerve electric stimulator and communicating with the internal nerve electric stimulator, comprising: a battery module for powering the external energy controller; an energy controller control unit for controlling the operation of the external energy controller; an upper computer communication module connected to the energy controller control unit, the energy controller control unit communicating with a program controller through the upper computer communication module; a storage module for storing electric stimulation signals and connected to the energy controller control unit; an inverter module connected to the battery module and the energy controller control unit, for converting direct current supplied by the battery module into alternating current; an energy controller compensation resonant network connected to the inverter module, for compensating the reactive power of the system, at least one energy controller coupling capacitor pole connected to the output end of the energy controller compensation resonant network; an energy controller harmonic communication module powered by the battery module and connected between the energy controller control unit and the energy controller coupling capacitor pole, for modulating and demodulating communication information; and a key and display module including keys and a display screen, the keys being used for inputting operation instructions, and the display screen being used for displaying input contents and information related to the operation of the internal nerve electric stimulator.

[0012] In the external energy controller, preferably, two energy controller coupling capacitor poles are included, wherein the energy controller compensation resonant network is configured as a series inductance compensation network in the following manner: one of the two energy controller coupling capacitor poles is connected to the inverter module through a first energy controller compensation inductor, and the other of the two energy controller coupling capacitor poles is directly connected to the inverter module.

[0013] In the external energy controller, preferably, two energy controller coupling capacitor poles are included, wherein the energy controller compensation resonant network is configured as an LCL compensation network topology in the following manner: one of the two energy controller coupling capacitor poles is connected to the inverter module through a second energy controller compensation inductor and a third energy controller compensation inductor in series; the other of the two energy controller coupling capacitor poles is directly connected to the inverter module to form a connection point, and the connection point is connected to the common connection end of the second energy controller compensation inductor and the third energy controller compensation inductor through a first energy controller compensation capacitor.

[0014] In the above-mentioned extracorporeal energy controller, preferably, two energy controller coupling capacitor poles are included, wherein the energy controller compensation resonant network is configured in a relay coil compensation resonant network structure in the following manner: a primary winding is connected to a first output end of the inverter module at one end, and connected to a second output end of the inverter module at the other end through a second energy controller compensation capacitor; and a secondary winding is connected to one of the energy controller coupling capacitor poles at one end, and connected to the other of the energy controller coupling capacitor poles at the other end.

[0015] In the above-mentioned extracorporeal energy controller, preferably, the energy controller control unit controls the energy controller harmonic communication module to generate an A-th harmonic wave equivalent to A times the output frequency of the inverter module, and modulates information into the A-th harmonic wave. Further preferably, the energy controller control unit controls the energy controller harmonic communication module to generate a B-th harmonic wave equivalent to B times the output frequency of the inverter module, and sends the B-th harmonic wave to the energy controller coupling capacitor poles. Alternatively, B can be equal to A.

[0016] In the above-mentioned extracorporeal energy controller, preferably, the host computer communication module is a Bluetooth module or a wifi module.

[0017] The present application also proposes a capacitive coupling energy transmission neural electrical stimulation system, which comprises the above-mentioned any one of the intracorporeal neural electrical stimulator and the above-mentioned extracorporeal energy controller.

[0018] In the above-mentioned capacitive coupling energy transmission neural electrical stimulation system, preferably, a program controller is further included, which has a program controller communication module in communication with the extracorporeal energy controller, and has a host computer control APP for realizing human-computer interaction control of the extracorporeal energy controller and the intracorporeal neural electrical stimulator.

[0019] In the above-mentioned capacitive coupling energy transmission neural electrical stimulation system, preferably, the program controller communication module is a Bluetooth module or a wifi module.

[0020] According to the implantable neural electrical stimulator system of the present application, since capacitive coupling is adopted to realize electrical energy transmission, greater electrical power can be transmitted, thereby expanding the application range.

[0021] The method and device of the present application have other characteristics and advantages, which will be apparent or will be described in detail in the accompanying drawings and subsequent detailed description incorporated herein, which together serve to explain the specific principles of the present application. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1A schematic block diagram of a neural electrical stimulator system is shown.

[0023] Figure 2 A schematic block diagram of a program controller is shown.

[0024] Figure 3 A schematic block diagram of an extracorporeal power controller is shown.

[0025] Figure 4 A schematic block diagram of an intracorporeal neural electrical stimulator is shown.

[0026] Figure 5 A schematic block diagram of a master chip structure of an intracorporeal neural electrical stimulator is shown.

[0027] Figure 6 A schematic diagram of a capacitively coupled capacitor plate implementation is shown.

[0028] Figure 7 A first embodiment of a compensated resonant network is shown.

[0029] Figure 8 A second embodiment of a compensated resonant network is shown.

[0030] Figure 9 A third embodiment of a compensated resonant network is shown.

[0031] Figure 10 A power-on authentication process of a master chip is shown.

[0032] Figure 11 A power-on reset waveform of a master chip is shown.

[0033] Figure 12 An impedance measurement flowchart is shown.

[0034] Figure 13 A flowchart of an electrical stimulation parameter write process is shown.

[0035] Figure 14 An electrical stimulation implementation flowchart is shown.

[0036] Figure 15 A first electrical stimulation waveform I is shown.

[0037] Figure 16 A second electrical stimulation waveform II is shown.

[0038] Figure 17 A third electrical stimulation waveform III is shown.

[0039] Figure 18 A fourth electrical stimulation waveform IV is shown.

[0040] Figure 19 A fifth electrical stimulation waveform V is shown.

[0041] Figure 20 A flow chart showing the manual adjustment mode is shown.

[0042] Figure 21 A flow chart showing the new device commissioning is shown.

[0043] It should be appreciated that the drawings are not necessarily drawn to scale, and that certain features of the application, which are of a nature to be exaggerated in the drawings, are shown in somewhat simplified form to facilitate explanation of the fundamental principles of the application. The particular design features of the application disclosed herein, including, for example, specific dimensions, orientations, positioning, and shapes, will be determined in part by the particular purpose of the application and the use environment in which the application is to be used.

[0044] In the drawings, like numerals refer to like parts throughout the several views of the drawings. DETAILED DESCRIPTION

[0045] Reference will now be made in detail to various embodiments of the application, examples of which are illustrated in the accompanying drawings and described below. The exemplary embodiments are examples and can be embodied in various forms without departing from the spirit of the application. Therefore, the present application is not limited to the exemplary embodiments described herein.

[0046] As Figure 1 shown, the capacitive coupling energy transfer neural electrical stimulation system of the present application comprises three parts: a program controller 01 (for example, hardware with IOS system, such as iPad, etc.) installed with a host computer control APP, an external energy controller 02, and an internal neural electrical stimulator 03. The program controller 01 and the external energy controller 02 can communicate through a Bluetooth module or an optional wifi module. The external energy controller 02 and the internal neural electrical stimulator 03 communicate through a harmonic communication module or a Bluetooth module. The internal neural electrical stimulator 03 obtains electrical energy from the external energy controller 02 through capacitive coupling.

[0047] The program controller 01 and the APP thereon serve as the main information interaction platform, and can realize all control, debugging procedures, and patient-related information query, internal neural electrical stimulator 03 configuration, etc. The doctor can manage patient information, set treatment programs, adjust parameter configurations, etc. through the program controller 01, and view relevant data recorded during the electrical stimulation treatment.

[0048] In the program controller 01 as Figure 2 shown, a Bluetooth module is provided. At this time, the program controller 01 communicates with the external energy controller 02 through Bluetooth protocol.

[0049] In addition, a wifi module can be integrated in the external controller, so that the doctor can remotely view the data of the patient and adjust the treatment plan. The wifi module can be an optional accessory, which is specified by the patient whether to configure.

[0050] The external controller 02 is a relay part for realizing data transmission and control, debugging, etc. between the program controller 01 and the internal nerve electric stimulator 03, and is also the main part for powering the internal device.

[0051] As shown in Figure 3 , the external controller 02 includes a controller control unit 201, a Bluetooth module 202, a storage module 203, an inverter module 204, a controller harmonic communication module 205, a battery module 206, and at least one controller coupling capacitor plate 207, a controller compensation resonance network 208, a key and display module 209. A wifi module 210 can also be selected, as shown in Figure 3 .

[0052] The external controller 02 communicates with the program controller 01 through the Bluetooth module 202, and configures the internal register data according to the information obtained from the program controller 01, stores all the parameters of the electric stimulation signal to be generated in the storage module 203 (non-volatile memory can be used), and can be stored reliably for a long time.

[0053] At the same time, the external controller 02 converts the direct current of the battery pack into high-frequency alternating current through the inverter module 204, adjusts it through the controller compensation resonance network 208, and sends it to the controller coupling capacitor plate 207 to supply power to the internal nerve electric stimulator 03. The main control chip modulates and demodulates information by using the 2nd or higher harmonic of the high-frequency alternating current generated by the inverter module 204 through the controller harmonic communication module 205, and realizes communication with the internal controller.

[0054] That is, in the external controller, the inverter circuit converts the direct current into alternating current, and the alternating current is composed of different order harmonics, among which the energy of the fundamental wave is the largest and is used for power transmission. In addition to the fundamental wave, the filter circuit also extracts the Ath harmonic and the Bth harmonic. The Ath harmonic is used to send information data to the inside, and the Bth harmonic is used to send data from the inside to the outside.

[0055] The internal nerve electric stimulator 03 includes at least one stimulator coupling capacitor plate 301 for receiving electric energy from the external controller, and discrete elements such as a rectifier circuit 302, a stimulator harmonic communication module 303, a filter capacitor 304, a stimulator compensation resonance network 305, etc. connected thereto. In addition, it also includes a main control chip 306 and a plurality of groups of stimulating electrodes 307 and balance capacitors 308 for realizing electric stimulation function. As shown in Figure 4 .

[0056] In addition, the in-vivo nerve electric stimulator 03 can also be configured with a Bluetooth module, because the capacitive coupling mode can deliver more electric energy. In this case, the in-vitro energy controller can also perform real-time bilateral communication with the in-vivo nerve electric stimulator 03 through Bluetooth.

[0057] The stimulator coupling capacitor plate 301 obtains electric energy from the energy controller coupling capacitor plate 207 of the in-vitro energy controller through capacitive coupling, and compensates for the reactive power through the stimulator compensation resonant network 305. The alternating current energy is converted into direct current energy through the rectifier circuit 302, and is filtered through the filtering capacitor 304, which can also store a small amount of electric energy. The rectified and filtered direct current energy is supplied to the main control chip 306. In addition, the stimulator harmonic communication module 303 is connected with the stimulator coupling capacitor plate 301 to realize the functions of modulating and demodulating harmonic signals. Data is exchanged with the main control chip.

[0058] The stimulation electrode 307 is the main execution component of the nerve electric stimulation, which implements current pulse stimulation on the nerve. The balancing capacitor 308 functions to ensure that the static charge of each electrode 307 is zero during the implementation of the nerve electric stimulation, so as to realize charge balance.

[0059] The main control chip 306 can realize the functions of configuration information storage, data calculation, control of electric stimulation pulse generation, etc., and is the main control component for realizing the in-vivo electric stimulation function. The main control chip 306 can also integrate a Bluetooth module, which replaces the function of the harmonic communication module. The internal block diagram of the main control chip 306 is shown in Figure 5 .

[0060] The main control chip 306 is internally configured with a controller, a memory, a controllable current source, an electrode interface circuit, a measurement feedback circuit, a modulation and demodulation circuit. In addition, a voltage stabilizing circuit and an overvoltage protection circuit are also configured at the power supply end to ensure that the supply voltage does not exceed the warning voltage value, thereby protecting the main control chip 306. The memory can use a non-volatile memory to realize power saving, and is used to reliably save the related setting parameters of the electric stimulation pulse for a long time. The Bluetooth module can be selected inside the chip to support the Bluetooth communication protocol.

[0061] The main control chip 306 controls the controllable current source circuit through the controller to generate the required current pulse stimulation signal, and sends the pulse to the specified electrode through the electrode interface circuit.

[0062] Figure 6 The implementation method of the energy controller coupling capacitor plate 207 and the stimulator coupling capacitor plate 301 is shown in the schematic diagram. Figure 6As shown, the energy controller coupling capacitor pole 207 of the external energy controller 02 and the stimulator coupling capacitor pole 301 of the internal neuro-electric stimulator 03 are arranged on the outside and inside of the patient's skin respectively when in use.

[0063] The operation of the capacitive coupling energy transmission neuro-electric stimulation system of the present application is described in detail below.

[0064] Electrical energy transfer process

[0065] The transmission of electric energy is mainly controlled by the external energy controller 02, and the battery module 206 in the external energy controller 02 is the main electric energy storage component. The energy controller control unit 201 converts the direct current electric energy provided by the battery module 206 into high-frequency alternating current through the control of the inverter module 204, and the frequency can be from 1 MHz to 40 MHz. Since the coupling between the energy controller coupling capacitor pole 207 and the stimulator coupling capacitor pole 301 is capacitive coupling, there is a large equivalent series capacitance, so in order to compensate for the reactive power of the system, the energy controller compensation resonance network 208 and the stimulator compensation resonance network 305 are arranged. For the stimulator compensation resonance network 305 of the internal implanted part, due to the need to consider the nuclear magnetic resonance compatibility and volume factors, a simple series inductance compensation or no compensation can be used.

[0066] However, the energy controller compensation resonance network 208 of the external energy controller part can have multiple optional implementation schemes.

[0067] Scheme 1 is the simplest series inductance compensation, as shown in Figure 7 .

[0068] Scheme 2 is an LCL compensation network topology, as shown in Figure 8 . Scheme 2 can effectively compensate for the reactive power while also transforming the impedance characteristics of the system and improving the problem of system resonance frequency drift.

[0069] Scheme 3 is a compensation resonance network scheme with a relay coil, in which the energy controller coupling capacitor pole 207 and the secondary winding of the relay coil produce strong resonance, which can increase the performance of the maximum transmission power of the system.

[0070] The electric energy can be transmitted to the rectifier circuit 302 in the internal neuro-electric stimulator 03 through the equivalent capacitance between the energy controller coupling capacitor pole 207 and the stimulator coupling capacitor pole 301, and the high-frequency alternating current energy is converted into direct current energy by the rectifier circuit 302 for use by the internal neuro-electric stimulator 03.

[0071] Communication implementation process

[0072] For the optional solution of the main control chip 306 of the in-vivo nerve electric stimulator 03 integrating the Bluetooth module, the communication can be realized through the Bluetooth transmission protocol, thus not described here. The following introduces the implementation scheme of using the harmonic communication module.

[0073] In the scheme of using the harmonic for communication, when the in-vivo nerve electric stimulator 03 transmits data to the in-vivo nerve electric stimulator 03, the controller control unit 201 controls the controller harmonic communication module 205 to generate the A-th harmonic equal to the A times of the output frequency of the inverter module 204, and modulates the information into the A-th harmonic. The modulation method can use the ASK mode. The A-th harmonic enters the in-vivo nerve electric stimulator 03 through the coupling of the controller coupling capacitor pole piece 207 and the stimulator coupling capacitor pole piece 301.

[0074] The stimulator harmonic communication module 303 in the in-vivo nerve electric stimulator 03 is configured with a filter circuit sensitive to the A-th harmonic. After being extracted by the filter circuit, it is sent to the main control chip 306 for processing.

[0075] When the in-vivo nerve electric stimulator 03 needs to read the data of the in-vivo nerve electric stimulator 03, the in-vivo nerve electric stimulator 03 controls the controller harmonic communication module 205 to generate the B-th harmonic, and sends the harmonic to the controller coupling capacitor pole piece 207.

[0076] The B-th harmonic can be transmitted to the in-vivo nerve electric stimulator 03 through the capacitive coupling between the controller coupling capacitor pole piece 207 and the stimulator coupling capacitor pole piece 301. The main control chip 306 controls the stimulator harmonic communication module 303 to modulate the impedance of the B-th harmonic, and uses the impedance modulation mode to transmit the data to the in-vivo nerve electric stimulator 03. The controller harmonic communication module 205 in the in-vivo nerve electric stimulator 03 measures the equivalent impedance value of the system under the B-th harmonic, so as to obtain the feedback data of the in-vivo nerve electric stimulator 03.

[0077] The A-th harmonic and the B-th harmonic can be different harmonic orders, or can be the same harmonic order. It can be a fixed harmonic order, or can be a real-time changing harmonic order. It can be a digital quantity modulation mode, or can be an analog quantity modulation mode.

[0078] Power-on authentication process for master chip

[0079] As Figure 10As shown. First, the external controller 02 transmits energy through capacitive coupling between the controller coupling capacitor 207 and the stimulator coupling capacitor 301, waiting for the main control chip 306 in the in vivo neurostimulator 03 to power on and reset. After the voltage across the filter capacitor 304 in the internal circuit of the in vivo neurostimulator 03 reaches the specified voltage, a reset signal is generated, the main control chip 306 starts working, and feeds back the chip ID (i.e., chip identifier). The power-on reset signal is as follows: Figure 11 As shown.

[0080] When the external controller 02 receives the chip ID information for the first time, it sends the information to the program controller 01 for confirmation and records the chip ID in the EEPROM memory, thus achieving device binding. After device binding, the program controller 01 is no longer required for subsequent authentication.

[0081] Impedance measurement process

[0082] The external controller 02 sends an impedance measurement request and a key to the internal neural stimulator 03. Upon receiving the request, the main control chip 306 of the internal neural stimulator 03 first verifies the validity of the key, and then begins the impedance measurement procedure. The measurement process is as follows: Figure 12 As shown.

[0083] The main control chip 306 first measures the output voltage of the rectifier circuit and sends this voltage value to the external energy controller 02. The external energy controller 02 then determines whether to make adjustments based on this voltage value. Figure 12 The display indicates whether to adjust the inverter module or whether to start the impedance measurement process. After receiving the command from the external controller to start the measurement process, the main control chip 306, according to the standard test procedure, controls the application of a current pulse of standard amplitude and duration to a specific electrode combination, measures the voltage between the transmitting and receiving electrodes, and stores the measured values ​​in a designated storage space within the main control chip 306 after AD conversion. After one electrical stimulation pulse cycle, the measurement data is sent to the external controller 02. After receiving and verifying the data, the external controller 02 sends the data to the program controller 01 and sends a confirmation message to the internal nerve stimulator 03. Upon receiving the confirmation message, the internal nerve stimulator 03 begins the impedance testing process for the next set of electrodes.

[0084] An "electrode combination" refers to a set of electrodes of the same polarity, including a set of emitting electrodes (where the electrodes in the set are positive), a set of returning electrodes (where the electrodes in the set are negative), and a set of vacant electrodes (where the electrodes in the set are zero). Various different electrode combinations can be formed by assigning electrode polarities.

[0085] This cycle continues until all impedance measurement procedures are implemented. All data are finally collected in the program controller 01 for storage and calculation, and the impedance between all electrodes that need to be measured are calculated.

[0086] Electrical stimulation implementation process

[0087] Figure 13 The writing process of the electrical stimulation parameters is shown. Through this process, the program controller 01 containing the host computer control APP only writes the electrical stimulation parameters to the in-vivo neural electrical stimulator 03 by the external controllable device 02. All required parameters of the electrical stimulation are stored in the memory of the in-vivo neural electrical stimulator 03.

[0088] The external transmitter does not need to actively control during the implementation of the conventional electrical stimulation. The implementation is as follows.

[0089] First, the power-on authentication process is performed. After the power-on authentication is completed, the in-vivo neural electrical stimulator 03 generates the required current source pulse stimulation signal according to the stored electrical stimulation parameters, and loads the stimulation signal to the corresponding electrode. Then, the actual stimulation current is measured, and the measured value is stored in the corresponding position of the data memory of the chip. When a electrical stimulation pulse is implemented, a charge balance process is implemented to restore the net charge on the electrode to 0, which can be divided into active charge balance process and passive charge balance process. The implemented electrical stimulation waveform can be the waveform as shown in Figure 15 、 Figure 16 、 Figure 17 、 Figure 18 、 Figure 19 The chip can output any shape of electrical stimulation waveform as long as the net charge at the end of a single electrode is zero through internal control.

[0090] After the charge balance process is completed, the entire pulse period is waited to end, and then a complete pulse stimulation process is implemented.

[0091] The master control chip 306 confirms the required direct current voltage value according to the feedback, and compares it with the actual direct current rectified voltage value output by the rectifier circuit 302.

[0092] When the rectified voltage value is insufficient, the master control chip 306 sends a request to the external controllable device 02 to increase the transmission power level. When the rectified voltage value is too high, the master control chip 306 sends a request to the external controllable device 02 to reduce the transmission power.

[0093] The external controllable device 02 adjusts the transmission power according to the received request.

[0094] Patient manual adjustment mode

[0095] The system provides a patient manual adjustment mode, which can be switched at any time according to the patient's personal feelings. There are two implementation methods for manual adjustment mode. As shown in Figure 20 .

[0096] Implementation method 1: manual adjustment of correction coefficient.

[0097] In implementation method 1, the patient manually adjusts a digital correction amount defined by the external controller 02. The external controller 02 sends the digital correction amount to the RAM of the internal neurostimulator 03, and the internal neurostimulator 03 superimposes the correction amount on the original stored stimulation amplitude parameter, and then outputs the stimulation pulse with the corrected amplitude.

[0098] Implementation method 2: open loop control mode.

[0099] In implementation method 2, the patient adjusts the transmission power of the external controller 02. The internal neurostimulator 03 switches to a voltage source type stimulation pulse mode. In this mode, the period, frequency, and corresponding electrode configuration of the stimulation pulse remain unchanged. However, the amplitude is directly loaded to the electrodes by the DC voltage output by the rectifier circuit 302 to implement stimulation. Therefore, the amplitude of the stimulation is controlled by the transmission power of the external controller 02. At this time, the control is open loop control, and the amplitude of the stimulation is completely manually adjusted by the patient.

[0100] New device commissioning

[0101] Figure 21 The flowchart of the new device debugging is shown.

[0102] Controlled by the program controller 01, the program controller 01 sends the debugging instructions to the external controller 02 through Bluetooth. The external controller 02 starts the debugging operation. As shown in Figure 21 .

[0103] The external controller 02 first starts the power-on authentication process.

[0104] After confirming that the chip ID is legal, the external controller 02 sends the device debugging instruction to the internal neurostimulator 03. After receiving the instruction, the internal neurostimulator 03 starts the impedance measurement program between electrodes.

[0105] After the impedance measurement is completed, the program controller 01 sets the stimulation parameters, and sends the parameter information to the internal neurostimulator 03 through the external controller 02. After receiving the stimulation parameters, the internal neurostimulator 03 stores all the parameters in the internal EEPROM.

[0106] After the parameters are stored, the main control chip 306 starts the following electrical stimulation test process according to the parameters:

[0107] First, the main control chip 306 implements several groups of electrical stimulation pulses according to the electrical stimulation parameters and completes the necessary measurement task, i.e., measuring the voltage between the electrodes. After the stimulation, the measurement data are transmitted to the program controller 01 containing the host computer APP through the external controllable device 02. Then the continuous transmission of the electrical stimulation pulses is started until the next command is received or the timer is exceeded.

[0108] Then, the program controller 01 containing the host computer APP adjusts the stimulation parameters according to the measurement data and the patient's feeling and then performs the above electrical stimulation test process again. This is repeated until all the electrical stimulation parameters are confirmed.

[0109] Finally, the program controller 01 containing the host computer APP transmits the finally confirmed parameters to the in-vivo neural electrical stimulator 03 through the external controllable device 02 for storage.

[0110] Stimulus current abnormality handling one

[0111] In the conventional electrical stimulation implementation process, a controllable current source circuit is used to generate the electrical stimulation pulses. If the measured current can never reach the theoretical control value, it is an abnormal situation of low current and needs to be handled. This is usually caused by insufficient amplitude of the rectified voltage output by the rectifier circuit 302 or changes in electrode impedance.

[0112] The main control chip 306 first checks the amplitude of the rectified voltage according to the abnormal handling program. If the amplitude of the rectified voltage is insufficient, a request for increasing the transmission power is sent to the external controllable device 02. If the amplitude of the rectified voltage is still insufficient after sending the request for N (a reasonable value) times in succession, a fault code is sent for processing by the external controllable device 02. If the amplitude of the rectified voltage is normal or returns to normal after several requests, the impedance measurement program is started.

[0113] After the impedance measurement program is completed, the measured impedance is compared with the original recorded impedance value. If an abnormality is confirmed, a fault code is sent to the external controllable device 02. If there is no abnormality, the conventional electrical stimulation program is tried again.

[0114] If the stimulation current abnormality disappears, the handling is completed. If the stimulation current abnormality still exists after the above-mentioned handling process is performed twice, it is possible that the in-vivo electrical stimulation itself has a fault, a fault code is sent to the external electrical stimulator, and the machine is stopped.

[0115] Stimulus current abnormality handling two

[0116] In some electric stimulation implementation, current over high abnormality may occur. Since current source circuit is used, it has the ability to suppress current over high by itself, so current over high abnormality usually means chip failure. The processing method is to report fault code to external controller 02 and stop.

[0117] Radio frequency rectification circuit output voltage abnormality

[0118] If the voltage amplitude is significantly insufficient, refer to the processing method of voltage amplitude deficiency in the "patient manual adjustment" section. This case is not within the scope of this item abnormality.

[0119] If the voltage amplitude is significantly over high, unknown interference source may occur. At this time, the main control chip 306 sends fault code and performs short circuit operation or impedance switching operation on the antenna, or changes the antenna structure, so as to suppress voltage over high and protect the in-vivo nerve electric stimulator 03.

[0120] Charge balancing method

[0121] The system uses a combination of active charge balance and passive charge balance.

[0122] A set of capacitors, i.e. balance capacitors 308, are connected in series between the interface circuit of the main control chip 306 and the stimulation electrodes 307. The balance capacitors 308 can ensure that the static charge on each electrode is zero. If the static charge on the electrode is not zero, the main control chip 306 controls the interface circuit to provide a discharge loop for the balance capacitors 308. The capacitor discharge process will automatically achieve charge balance of each electrode.

[0123] When the electric stimulation pulse frequency is low, the time between two electric stimulation pulses is usually long enough to allow the balance capacitors to fully discharge and complete passive charge balance.

[0124] When the electric stimulation frequency is high, the time between two pulses may not be sufficient to fully discharge the capacitors, so active charge balance is needed. That is, after implementing an electric stimulation pulse, all configured electrodes are reversed (the transmitting electrode becomes the return electrode, the return electrode becomes the transmitting electrode, and the idle electrode remains unchanged), and then another electric stimulation pulse of the same amplitude is implemented. It is equivalent to implementing a forward pulse on the electrode, and then immediately implementing a reverse pulse of the same amplitude.

[0125] The active charge balance method can also be applied in reverse, i.e. a reverse pulse is implemented first, and then a forward pulse is implemented immediately. This implementation method can output an electric stimulation pulse of a higher current amplitude that cannot be output otherwise.

[0126] For convenience of explanation and precise definition of the appended claims, the terms "upper", "lower", "inner" and "outer" are used to describe features of the exemplary embodiments with reference to the positions of these features shown in the drawings.

[0127] The foregoing description of specific exemplary embodiments of the application has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the application to the precise form disclosed, and various changes and modifications can be effected and should be seen as within the scope of the application as defined by the appended claims. The exemplary embodiments were chosen and described in order to explain the principles of the application and its practical application to thereby enable others skilled in the art to best utilize the application and various embodiments with various modifications as are suited to the particular use contemplated.

[0128] List of reference signs:

[0129] 01 program controller

[0130] 02 external controllable device

[0131] 201 controllable device control unit

[0132] 202 Bluetooth module

[0133] 203 storage module

[0134] 204 inverter module

[0135] 205 controllable device harmonic communication module

[0136] 206 battery module

[0137] 207 controllable device coupling capacitor plate

[0138] 208 controllable device compensation resonant network

[0139] 209 key and display module

[0140] 210 wifi module

[0141] 03 internal neural electrical stimulator

[0142] 301 stimulator coupling capacitor plate

[0143] 302 rectifier circuit

[0144] 303 stimulator harmonic communication module

[0145] 304 filter capacitor

[0146] 305 stimulator compensation resonant network

[0147] 306 master control chip

[0148] 307 stimulating electrode

[0149] 308 balancing capacitor

Claims

1. An in vivo neurostimulator (03), comprising: At least one stimulator coupling capacitor electrode (301) is used to couple with the controller coupling capacitor electrode (207) of the external controller (02), thereby receiving electrical energy from the external controller (02) and exchanging information. Stimulator compensation resonant network (305) is connected to stimulator coupling capacitor plate (301) to compensate for reactive power in the received electrical energy; A rectifier circuit (302) is connected to a stimulator compensation resonant network (305) to convert compensated AC power into DC power. The filter capacitor (304) is connected to the rectifier circuit (302) to perform DC filtering on the rectified DC power. The main control chip (306) controls the operation of the in vivo nerve electrical stimulator, is connected to the rectifier circuit (302) and the filter capacitor (304) and receives power from them; The stimulator harmonic communication module (303) is connected between the stimulator coupling capacitor electrode (301) and the main control chip (306) and is used to modulate and demodulate the communication information; Multiple sets of stimulation electrodes (307) and corresponding balancing capacitors (308), wherein each balancing capacitor (308) is connected between the main control chip (306) and the corresponding stimulation electrode (307), receives stimulation pulses from the main control chip (306) and applies them to the corresponding stimulation electrode (307), and achieves charge balance; The external energy controller (02) generates high-frequency alternating current, which includes a fundamental wave and harmonics. The internal nerve stimulator (03) receives electrical energy through the fundamental wave and exchanges information through the harmonics.

2. The in vivo neuroelectric stimulator (03) according to claim 1, comprising two stimulator coupling capacitor plates (301), wherein the stimulator compensation resonant network (305) is configured such that one of the two stimulator coupling capacitor plates (301) is connected to the rectifier circuit (302) through a stimulator compensation inductor (L3), and the other of the two stimulator coupling capacitor plates (301) is directly connected to the rectifier circuit (302).

3. The in vivo neuroelectric stimulator (03) according to claim 1, wherein the stimulator harmonic communication module (303) includes a filter circuit sensitive to the A-harmonic, thereby extracting information from the A-harmonic in the received signal and transmitting the information to the main control chip (306).

4. The in vivo neuroelectric stimulator (03) according to claim 3, wherein the stimulator harmonic communication module (303) further includes a filter circuit sensitive to the B-th harmonic, thereby extracting the B-th harmonic from the received signal, wherein the main control chip (306) controls the stimulator harmonic communication module (303) to modulate the impedance of the B-th harmonic, and the impedance-modulated data is sent to the external energy controller by the stimulator coupling capacitor electrode (301).

5. The in vivo neurostimulator (03) according to claim 4, wherein B equals A.

6. An external energy controller (02) for transmitting electrical energy to and communicating with an in vivo neurostimulator, comprising: A battery module (206) is used to power the external energy controller (02); The energy controller control unit (201) is used to control the operation of the external energy controller (02); The host computer communication module (202) is connected to the energy controller control unit (201), and the energy controller control unit (201) communicates with the program controller (01) through the host computer communication module (202); A storage module (203) is used to store electrical stimulation signals and is connected to the energy controller control unit (201). An inverter module (204), which is connected to the battery module (206) and the energy controller control unit (201), is used to convert the DC power supplied by the battery module (206) into AC power; A resonant network (208) for power control compensation, connected to the inverter module (204), compensates for the reactive power of the system. At least one energy controller coupling capacitor electrode (207) is connected to the output of the energy controller compensation resonant network (208); The energy controller harmonic communication module (205) is powered by the battery module (206) and is connected across the energy controller control unit (201) and the energy controller coupling capacitor plate (207) for modulating and demodulating communication information; as well as A button and display module (209) includes buttons and a display screen, wherein the buttons are used to input operation commands and the display screen is used to display input content and information related to the operation of the in vivo neurostimulator; The external energy controller (02) generates high-frequency alternating current, which includes a fundamental frequency and harmonics. The external energy controller (02) transmits electrical energy through the fundamental frequency and exchanges information through the harmonics.

7. The external controller (02) according to claim 6, comprising two controller coupling capacitor plates (207), wherein the controller compensation resonant network (208) is configured as a series inductor compensation network in such a way that one of the two controller coupling capacitor plates (207) is connected to the inverter module (204) through a first controller compensation inductor (L21), and the other of the two controller coupling capacitor plates (207) is directly connected to the inverter module (204).

8. The external controller (02) according to claim 6, comprising two controller coupling capacitor plates (207), wherein the controller compensation resonant network (208) is configured as an LCL compensation network topology in such a way that one of the two controller coupling capacitor plates (207) is connected in series to the inverter module (204) through a second controller compensation inductor (L22) and a third controller compensation inductor (L23); the other of the two controller coupling capacitor plates (207) is directly connected to the inverter module (204) to form a connection point, the connection point being connected to the common connection terminal of the second controller compensation inductor (L22) and the third controller compensation inductor (L23) through a first controller compensation capacitor (C1).

9. The external controller (02) according to claim 6, comprising two controller coupling capacitor plates (207), wherein the controller compensation resonant network (208) is configured as a compensation resonant network structure with a relay coil in the following manner: comprising a primary winding and a secondary winding, one end of the primary winding being connected to the first output terminal of the inverter module (204), and the other end of the primary winding being connected to the second output terminal of the inverter module (204) through a second controller compensation capacitor (C2); one end of the secondary winding being connected to one of the controller coupling capacitor plates (207), and the other end of the secondary winding being connected to the other of the controller coupling capacitor plates (207).

10. The external energy controller (02) according to claim 6, wherein the energy controller control unit (201) controls the energy controller harmonic communication module (205) to generate an A-th harmonic that is A times the output frequency of the inverter module (204), and modulates information into the A-th harmonic.

11. The external energy controller (02) according to claim 10, wherein the energy controller control unit (201) controls the energy controller harmonic communication module (205) to generate a B-th harmonic that is B times the output frequency of the inverter module (204), and sends the B-th harmonic to the energy controller coupling capacitor plate (207).

12. The external energy controller (02) according to claim 11, wherein B is equal to A.

13. The external energy controller (02) according to claim 6, wherein the host computer communication module (202) is a Bluetooth module or a Wi-Fi module.

14. A capacitively coupled power transfer neurostimulation system comprising an in vivo neurostimulator (03) according to any one of claims 1 to 5 and an external power controller (02) according to any one of claims 6 to 13.

15. The capacitively coupled nerve stimulation system according to claim 14 further includes a program controller (01), the program controller (01) having a program controller communication module that communicates with the external energy controller (02), and having a host computer control APP for realizing human-computer interaction control of the external energy controller (02) and the internal nerve stimulator (03).

16. The capacitively coupled power transfer neural electrical stimulation system according to claim 15, wherein the program controller communication module is a Bluetooth module or a Wi-Fi module.

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