WO2022218125A1 - 植入式神经刺激器系统 - Google Patents

植入式神经刺激器系统 Download PDF

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Publication number
WO2022218125A1
WO2022218125A1 PCT/CN2022/082960 CN2022082960W WO2022218125A1 WO 2022218125 A1 WO2022218125 A1 WO 2022218125A1 CN 2022082960 W CN2022082960 W CN 2022082960W WO 2022218125 A1 WO2022218125 A1 WO 2022218125A1
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WO
WIPO (PCT)
Prior art keywords
energy controller
external energy
implantable
implantable neurostimulator
stimulation
Prior art date
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PCT/CN2022/082960
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English (en)
French (fr)
Inventor
徐天睿
Original Assignee
北京领创医谷科技发展有限责任公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Priority claimed from CN202110412431.9A external-priority patent/CN113274640A/zh
Priority claimed from CN202110412753.3A external-priority patent/CN112972896A/zh
Application filed by 北京领创医谷科技发展有限责任公司 filed Critical 北京领创医谷科技发展有限责任公司
Priority to EP22787354.4A priority Critical patent/EP4324511A1/en
Priority to US18/554,709 priority patent/US20240042218A1/en
Publication of WO2022218125A1 publication Critical patent/WO2022218125A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37247—User interfaces, e.g. input or presentation means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/3615—Intensity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A61N1/37223—Circuits for electromagnetic coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/378—Electrical supply
    • A61N1/3787—Electrical supply from an external energy source

Definitions

  • the present invention relates to an implantable nerve stimulation system, comprising an external energy controller and a corresponding implantable nerve stimulator.
  • the present invention also relates to the above-mentioned external energy controller.
  • Neurostimulation systems incorporating implantable neurostimulators have been widely used in the medical field.
  • an implantable neurostimulator is implanted into a patient to effect treatment of the patient site.
  • the treatment regimen includes, for example, the pulse width, frequency, etc. of the stimulation pulses. This is undoubtedly painful for patients with long treatment cycles.
  • Chinese invention patents CN104080509B and CN107789730B disclose such neural stimulator systems.
  • the implantable neurostimulator performs radio frequency communication and energy transmission with the external energy controller, and the external energy controller provides electrical stimulation pulses in real time to drive the stimulation electrodes of the implantable neurostimulator, thereby applying stimulation to the patient's treatment site. and the external energy controller provides radio frequency electric energy to the implantable neural stimulator to maintain the operation of the implantable neural stimulator.
  • radio frequency-based neurostimulators can obtain unlimited power supply, so there is no need to worry about battery drain. Moreover, this radio frequency-based implantable neurostimulator can adjust the electrical stimulation pulse at any time by the external energy controller according to the treatment plan. So there is no need to worry about repeated implants due to battery drain and changing treatment regimens.
  • CN107789730B adopts a dual-frequency working mode, at the cost of increasing the complexity of the product and manufacturing cost, and may lead to an increase in the size of the implantable neurostimulator. And this volume increase is obviously not conducive to the implantation of neurostimulators.
  • the electrical stimulation pulses of the implantable neurostimulator are provided by the external controller in real time, it is necessary to ensure reliable communication between the neurostimulator implanted in the patient and the external controller.
  • the reliability of this communication will be affected by many factors. For example, when the external energy controller is far away from the patient for some reason, or when the external energy controller is accidentally impacted or damaged, even for a very short time, the treatment process of the implantable neurostimulator will be detrimental. influences.
  • the purpose of the present invention is to provide an external energy controller of a nerve stimulation system, which constitutes a nerve stimulation system together with an implantable nerve stimulator through radio frequency communication.
  • the nerve stimulation system can also include upper computer software to facilitate operation and setting. Its characteristic is that the operation control of the implantable neurostimulator is not completed by the external energy controller, but is realized by the main control chip that comes with the implantable neurostimulator; the external energy controller is used to configure the implanted neurostimulator. It stores clinical treatment parameters of the implantable neurostimulator and stores operational data from the implantable neurostimulator, and adjusts transmit power in response to commands from the implantable neurostimulator. Thereby, the problems of treatment safety and product complexity caused by the need for real-time communication in the prior art implantable neurostimulator system are overcome.
  • the present invention provides an implantable neurostimulator system, comprising an implantable neurostimulator and an external energy controller, the implantable neurostimulator has a stimulator antenna module, and the external energy controller has a controller antenna module, through the stimulator antenna module and the controller antenna module, the implantable neurostimulator communicates with the external controller in a radio frequency manner and receives electrical energy, wherein the implantable neurostimulator has A main control CPU, a main control memory, and a stimulation electrode, the main control memory for storing control information including clinical stimulation parameters, the main control CPU using the clinical stimulation parameters to actively generate a stimulation pulse sequence and apply the stimulation pulse sequence to the stimulation electrode.
  • the implantable neural stimulator further comprises a rectifier energy storage circuit and a pre-measurement feedback circuit, and the rectified energy storage circuit is used to store the received electrical energy,
  • the pre-measurement feedback circuit is used to measure the electric energy storage amount in the rectifier energy storage circuit.
  • the main control CPU sends a power adjustment instruction to the external energy controller, and the in vitro energy The controller adjusts the transmit power of the external energy controller according to the received power adjustment instruction.
  • the implantable neurostimulator further comprises a post-measurement feedback circuit, and the post-measurement feedback circuit is used to measure the real-time stimulation parameters on the stimulation electrodes and transmit them
  • the main control CPU stores the real-time stimulation parameters in the main control memory, and periodically sends the real-time stimulation parameters to the external energy controller, or responds to data reading instructions to The real-time stimulation parameters are sent to the external energy controller;
  • the in vitro energy controller includes a storage unit to store the real-time stimulation parameters received from the implantable neurostimulator.
  • the external energy controller further comprises an input device, a display device and a power supply; the input device and the display device are used to realize human-computer interaction, so as to facilitate the implantation
  • the implantable neurostimulator sends the control information; the control information includes instructions to modify clinical stimulation parameters.
  • control information further includes an up/down gear instruction, so as to adjust the stimulation intensity of the stimulation pulse sequence as required.
  • the external energy controller further comprises a storage unit, which stores the operation program of the external energy controller, the information input from the input device, and the data from the implantable neurostimulator. data received by the receiver;
  • the control information also includes the data reading instructions to read operational data including real-time stimulation parameters from the implantable neurostimulator at any time.
  • the implantable neurostimulator system further includes a host computer as a control and information processing platform, the external energy controller further includes a host computer communication module, the host computer The computer communicates with the external energy controller through the host computer communication module, so as to send instructions to the implantable neural stimulator through the external energy controller, or read data from the external energy controller.
  • the upper computer communication module is a wireless communication module such as Bluetooth.
  • the host computer has host computer software, and the user can send instructions to the external energy controller of the neurostimulation system through the host computer software, so as to control the neurostimulation system.
  • the external energy controller of the neurostimulation system is used to operate, or the implantable neurostimulator is operated through the external energy controller of the neural stimulation system, and the operation includes setting, measuring, programming, and data management of clinical stimulation parameters, so
  • the data involved in the data management includes measurable related parameters, correction data and observation variables generated when the external controller of the neurostimulation system and the implantable neurostimulator are operating.
  • the upper computer software can operate the upper computer to connect to a network or an internal server, so as to backup and update programs and data.
  • the electrical pulse stimulation is implemented based on the combination of treatment parameters stored in the main control memory of the implantable neurostimulator, it is only necessary to provide radio frequency power from the external energy controller, and it is not necessary to obtain real-time electrical pulses containing stimulation from the external energy controller Therefore, the reliability of the operation of the implantable neurostimulator is improved, and there is no need to worry about treatment failure caused by sudden communication interruption or poor communication.
  • the implantable nerve stimulator itself has an energy storage circuit, it can also ensure a short-term power supply in the case of sudden communication interruption or poor communication, so as not to interrupt the treatment.
  • the memory of the implantable neurostimulator can store various operating parameters, and can send these data to the external energy controller during intermittent periods of treatment or when the communication is not busy, it can further ensure the smooth flow of communication when it is required, thereby improving the equipment. performance.
  • Figure 1 shows a functional block diagram of one embodiment of a neural stimulation system incorporating the extracorporeal controller of the present invention.
  • Figure 2 shows a functional block diagram of another embodiment of a neural stimulation system incorporating the extracorporeal controller of the present invention.
  • FIG. 3 shows a functional block diagram of the external controller of the neurostimulation system of the present invention.
  • FIG. 4 shows a functional block diagram of the implantable neurostimulator in the implantable neurostimulator system of the present invention.
  • FIG. 5 shows a functional block diagram of another implantable neurostimulator in the implantable neurostimulator system of the present invention.
  • FIG. 1 shows a functional block diagram of one embodiment of a neurostimulation system incorporating an extracorporeal controller of the present invention.
  • the neural stimulation system includes two parts: an implantable neural stimulator 1 and an external energy controller 2 .
  • Figure 2 shows a functional block diagram of another embodiment of a neural stimulation system incorporating the extracorporeal controller of the present invention.
  • the embodiment in FIG. 2 adds a host computer 3 .
  • the host computer is not necessary. Adding a host computer helps to improve the human-computer interaction function, making it easier for doctors or patients to operate the neurostimulation system, and to set more complex functions for the neurostimulation system.
  • FIG. 3 shows a functional block diagram of the external controller of the neurostimulation system of the present invention.
  • the external energy controller 2 of the neurostimulation system of the present invention transmits electrical energy to and communicates with the implantable neurostimulator 1 by means of radio frequency.
  • the external energy controller 2 of the neurostimulation system of the present invention includes: an input device 20 , the in vitro energy controller 2 receives information through the input device 20 ; an antenna module 21 , an antenna module 21 and an implantable neurostimulator The stimulator antenna of 1 performs radio frequency coupling, thereby sending input signals containing electrical energy and control information to the implantable neural stimulator 1, and can receive instructions and data from the implantable neural stimulator 1; display device 22, the display The device 22 displays the current state of the external energy controller 2 and the information input from the input device 20, and also displays the data and instructions received from the implantable neurostimulator 1; the storage unit 23 stores the operation program of the external energy controller 2 , the information input from the input device 20 and the data received from the implantable neurostimulator 1; the power supply 24 for power
  • the user can operate the input device.
  • the information input from the input device 20 may include information to configure the external controller 2 , information to configure the implantable neurostimulator 1 , and instructions to read data to the implantable neurostimulator 1 .
  • any information of the external energy controller 2 itself can also be displayed, including the information stored in the storage unit 23 (eg, operating data from the implantable neurostimulator 1).
  • the input device 20 may be any device suitable for inputting information, such as keys, handwriting screens, and voice input microphones.
  • the input device 20 has a stimulation intensity adjustment unit, which can adjust the stimulation intensity of the implantable neural stimulator 1 in a manner of increasing or decreasing gears.
  • the stimulation intensity adjustment unit may be an up/down button, or a virtual button displayed on the screen.
  • the display device 22 may be any device capable of displaying information, such as a liquid crystal display screen, an LED display, and the like.
  • the storage unit 23 is preferably a non-volatile memory in order to store data even after a power failure.
  • the external energy controller 2 of the neurostimulation system only needs to be configured for each patient according to the treatment plan before each treatment stage, and it can be applied to the entire treatment stage. Therefore, frequent setting of the extracorporeal controller 2 of the neurostimulation system by the doctor is avoided.
  • the power source 24 can be an ordinary battery or a rechargeable battery.
  • the above-mentioned instruction received from the implantable neurostimulator 1 is an instruction to adjust the transmit power of the external energy controller, and the control unit 25 adjusts the transmit power of the antenna module 21 according to the instruction to conform to the transmit power of the implantable neurostimulator 1. operational requirements. This way of adjusting the transmit power according to the operating requirements of the implantable neural stimulator 1 is obviously more helpful to ensure the reliable operation of the implantable neural stimulator 1 .
  • the external energy controller 2 of the neurostimulation system of the present invention may also have a host computer communication module 26 for receiving instructions from the host computer 3 and sending data to the host computer 3. Configure or configure the implantable neurostimulator 2; or for transmitting various data of the external energy controller 2 of the neurostimulation system and data from the implantable neurostimulator 1 to the host computer 3.
  • the host computer 3 may have a dedicated host computer software, and the user can send instructions to the external energy controller 2 of the neurostimulation system through the host computer software, so as to operate the external energy controller 2 of the neurostimulation system, or through the neural stimulation system.
  • the external energy controller 2 of the system operates the implantable neurostimulator 1, and the operation includes setting, measuring, programming, and data management of clinical stimulation parameters.
  • the upper computer software can also operate the upper computer 3 to connect to a network or an internal server to back up and update programs and data.
  • the upper computer 3 and the included upper computer software can improve the convenience of operation and help to set a more complicated treatment plan.
  • the host computer communication module 26 of the external energy controller 2 of the neurostimulation system of the present invention may be a wireless communication module, so as to exchange commands and data with the host computer 3 in an infinite communication manner.
  • the infinite communication method can make the connection between the external energy controller 2 of the nerve stimulation system and the upper computer 3 more convenient, thereby improving the convenience of operation and the simplicity of product design.
  • the above-mentioned wireless communication module may be a Bluetooth module.
  • the extracorporeal controller 2 of the neurostimulation system of the present invention is often designed to be worn on the body, so as to be able to move anywhere with the patient.
  • This kind of wearable design needs to minimize the size of the product, so the size of its battery will also be minimized, which requires full consideration of the energy-saving design of the device.
  • Bluetooth communication has the characteristics of low power consumption, which can well meet this energy-saving demand.
  • the implantable neurostimulator 1 as an in vivo treatment device, requires high safety. That is, to prevent illegal operators or illegal external control devices from interfering with the implantable neurostimulator 1.
  • Bluetooth also provides two layers of password protection, which can effectively prevent this illegal intrusion risk.
  • the above wireless communication module may also be a WIFI module.
  • WIFI communication has a fast transmission speed, which helps to meet this demand.
  • the external energy controller 2 of the neurostimulation system of the present invention does not need to send real-time stimulation signals including stimulation electrical pulses to the implantable neurostimulator 1, but only needs to provide radio frequency power, so even if the communication is interrupted due to an emergency Or poor communication will not lead to treatment failure.
  • the implantable neurostimulator 1 can send these data to the external energy controller during the intermittent period of treatment or when the communication is not busy
  • the external energy controller 2 of the neurostimulation system of the present invention can further ensure that the communication is kept unblocked when communication is required. , thereby improving the performance of the device. For example, while the doctor or patient operates the external energy controller to send instructions to the implantable neurostimulator, the implantable neurostimulator will not send data to the outside to ensure smooth communication.
  • the external energy controller 2 of the neurostimulation system of the present invention receives an instruction to adjust the transmit power from the implantable neurostimulator, and adjusts the transmit power of the antenna module in response to the instruction, so the implantable neurostimulator 1 can obtain Stable power supply.
  • the implantable neurostimulator system of the present invention includes an implantable neurostimulator 1 and an external energy controller 2.
  • the implantable neurostimulator 1 communicates with the external energy controller through radio frequency.
  • the device 2 communicates and receives electrical energy, wherein the implantable neurostimulator has a main control CPU, a main control memory and stimulation electrodes, the main control memory is used to store control information including clinical stimulation parameters, and the main control CPU A stimulation pulse sequence is actively generated using the clinical stimulation parameters and applied to the stimulation electrodes.
  • the implantable neural stimulator 1 further includes a rectification energy storage circuit and a pre-measurement feedback circuit, the rectified energy storage circuit is used to store the received electrical energy, and the pre- A measurement feedback circuit is set to measure the electric energy storage amount in the rectifier energy storage circuit.
  • the main control CPU sends a power adjustment command to the external energy controller, thereby adjusting the power of the external energy controller. transmit power.
  • the implantable neurostimulator 1 further includes a post-measurement feedback circuit, which is used to measure the real-time stimulation parameters on the stimulation electrodes and transmit them to the
  • the main control CPU stores the real-time stimulation parameters in the main control memory, and periodically sends the real-time stimulation parameters to the external energy controller, or responds to a data reading instruction to send the real-time stimulation parameters
  • the parameters are sent to the extracorporeal controller; the extracorporeal controller includes a storage unit to store real-time stimulation parameters received from the implantable neurostimulator.
  • the external energy controller 2 further includes an input device, a display device and a power supply; the input device and the display device are used to realize human-computer interaction, so as to provide the implantable neurostimulator with Send the control information; the control information includes an instruction to temporarily modify the clinical stimulation parameters, and after the system is restarted, the temporarily modified clinical stimulation parameters will be restored to the original set values.
  • control information further includes an up/down gear instruction, so as to adjust the stimulation intensity of the stimulation pulse sequence as required.
  • control information further includes the data reading instruction, so as to read the operation data including real-time stimulation parameters from the implantable neurostimulator at any time.
  • Figure 2 shows a functional block diagram of another embodiment of an implantable neurostimulator system incorporating the present invention.
  • the embodiment in FIG. 2 adds a host computer 3 .
  • the host computer is not necessary. Adding a host computer helps to improve the human-computer interaction function, making it easier for doctors or patients to operate the neurostimulation system, and to set more complex functions for the neurostimulation system.
  • a host computer is added as a control and information processing platform, and the external energy controller also includes a host computer communication module.
  • the host computer communication module communicates with the external energy controller, so as to send instructions to the implantable neural stimulator through the external energy controller, or read data stored in the external energy controller.
  • the communication module of the upper computer can be a wireless communication module, such as a Bluetooth communication module, so as to make the communication connection more convenient.
  • the above-mentioned upper computer may also have a data analysis and management system for analyzing and managing the data read from the external energy controller, thereby helping to specify and modify the combination of clinical stimulation parameters.
  • FIG. 4 shows a functional block diagram of the implantable neurostimulator in the neurostimulation system of the present invention.
  • the implantable neurostimulator 1 of the present invention which communicates with the external energy controller and receives electrical energy by radio frequency, includes: a main control chip 11, the main control chip includes a main control CPU 111, The main control memory 112 and the digital-to-analog conversion current source circuit (i-DAC) 113; the stimulator antenna and its impedance matching circuit 12, which are RF-coupled with the external energy controller to receive information including power and control from the external energy controller input signal, and can send data to the external energy controller; rectifier energy storage circuit 13, which is respectively connected to the impedance matching circuit 12 and the main control chip 11, so as to extract and store electrical energy from the received input signal power supply to the main control chip 11; modulation/demodulation circuit 14, which is connected to the impedance matching circuit 12 and the main control chip 11, so as to extract control information from the received input signal, and to The control information is transmitted to the main control chip 11, and the data sent by the main control chip 11 is modulated and then transmitted to the impedance matching circuit, and sent to
  • the main control memory 112 is preferably non-volatile memory so that data can be stored even after a power failure. In this way, the implantable neurostimulator 1 only needs to be configured for each patient according to the treatment plan before each treatment stage, and it can be applied to the whole treatment stage. Therefore, frequent settings of the implantable neurostimulator 1 by the physician are avoided.
  • the clinical stimulation parameter combination may include multiple groups, each group of clinical stimulation parameter combination has its own code, the control information further includes clinical stimulation parameter code, the clinical stimulation parameter code and the multiple groups of clinical stimulation parameters stored in the main control memory.
  • the codes for stimulus parameter combinations correspond one-to-one. In this way, the user (doctor or patient) can directly call the corresponding treatment plan (corresponding to the corresponding clinical stimulation parameter combination) by operating the external energy controller according to the treatment process. It avoids the trouble of frequently configuring implantable neurostimulators as the patient's condition improves.
  • the above-mentioned control information further includes an up/down shift control instruction, and the main control chip 11 adjusts the pulse intensity of the stimulation pulse sequence in a stepwise manner in response to the up/down shift control instruction. In this way, patients can adjust the intensity of stimulation at any time according to their own experience.
  • the control information further includes a data read instruction, and the main control CPU sends the corresponding data stored in the main control memory to the external energy controller 2 in response to the data read instruction.
  • the patient or doctor can obtain various combination of treatment parameters stored in the implantable neurostimulator 1, and can also obtain the data generated by the operation of the implantable neurostimulator 1.
  • Implantable neurostimulators use sequences of stimulation pulses to treat patients.
  • the pulse frequency is high, the charge between adjacent stimulation pulses cannot be fully released, thus making the actual pulse waveform sequence different from the pulse waveform sequence required for treatment. This will affect the effectiveness of the treatment and also reduce the lifespan of the implantable neurostimulator itself.
  • the parameters of the clinical stimulation parameter combination further include a charge balance time, and the length of the charge balance time is sufficient to ensure that the charges between adjacent electrical stimulation pulses are fully released, so as to achieve passive charge balance. This overcomes the problem that the electric charge between adjacent electrical stimulation pulses existing in the existing neural stimulator cannot be released.
  • a charge balance circuit 17 is also connected between the electrode interface 15 and the digital-to-analog conversion current source circuit 113 of the main control chip 11 , and the charge balance circuit 17 can Active charge balancing is achieved by applying reverse pulses to the electrode interface 15 between adjacent electrical stimulation pulses. Compared with passive charge balancing of natural discharge, active charge balancing can complete the discharge process faster. Clearly, this active charge balancing allows for higher stimulation pulse frequencies. Conversely, the charge balancing circuit 17 is not necessary, depending on the frequency of the stimulation pulses used by the implantable neurostimulator 1 .
  • the implantable neural stimulator 1 further includes an operating data storage 18 for storing various operating data generated during the operation of the implantable neural stimulator.
  • the control information received from the external energy controller also includes a data reading instruction, and the main control CPU 111 sends the data stored in the operating data memory 18 to the external energy controller 2 in response to the data reading instruction.
  • the operating data memory 18 is not necessary, and various operating data generated during the operation of the implantable neurostimulator can also be stored in a certain partition of the main control memory 112, as long as the storage capacity of the main control memory is sufficient Big enough.
  • the operating data memory 18 is preferably a non-volatile memory in order to store data even after a power failure. In this way, within the range allowed by the storage space, the external energy controller can retrieve the operation data of the implantable neural stimulator as needed within a period of time. Data loss due to sudden communication interruption is also prevented.
  • the implantable nerve stimulator 1 further includes a post-measurement feedback circuit 19, and the post-measurement feedback circuit 19 is respectively connected to the electrode interface 15 and the main control chip 11, so as to measure
  • the real-time stimulation parameters on the stimulation electrodes 16 are transmitted to the main control chip 11 , and the main control chip stores the real-time stimulation parameters in the operation data memory 18 .
  • the main control chip 11 can compare the real-time stimulation parameters with the stored clinical stimulation parameters, and correct the stimulation signals applied to each stimulation electrode according to the comparison results.
  • the post-measurement feedback circuit is not necessary.
  • the implantable neurostimulator can be designed into a simple and reliable working mode without the need to measure the working parameters of the stimulation electrodes. Doing so helps keep costs down.
  • the implantable nerve stimulator 1 shown in FIG. 4 further includes a pre-measurement feedback circuit 10 , and the pre-measurement feedback circuit 10 is arranged between the rectifier energy storage circuit 13 and the main control chip 11 . , so as to measure the real-time electric energy storage amount in the rectifier energy storage circuit 13 at any time and transmit it to the main control chip 11 , and the main control chip stores the real-time electric energy storage amount in the operation data memory 18 .
  • the main control chip 11 evaluates whether it is necessary to adjust the electric energy input by the radio frequency according to the real-time electric energy storage amount. When the real-time electric energy storage amount is lower than the set value, the main control chip 11 passes the stimulator antenna and its impedance matching circuit. 12 Send a power adjustment command to the antenna of the external energy controller 2, so as to adjust the transmit power of the external energy controller 2.
  • the implantable neurostimulator 1 of the present invention has a main control memory and an operating data memory.
  • the main control chip 11 can actively send data to the external energy controller, that is, periodically send various data stored in the main control memory and/or operating data memory to the in vitro energy controller.
  • the main control chip 11 only includes a main control CPU 111, a main control memory 112 and a digital-to-analog conversion current source circuit (i-DAC) 113, wherein the circuit part serves as a Peripheral circuits.
  • i-DAC digital-to-analog conversion current source circuit
  • the main control chip 11 includes a main control CPU 111, a main control memory 112, and a digital-to-analog conversion current source circuit (i-DAC) 113, Pre-measurement feedback circuit 110 , modulation/demodulation circuit 114 , electrode interface 115 , charge balance circuit 117 , operating data memory 118 , and post-measurement feedback circuit 119 .
  • i-DAC digital-to-analog conversion current source circuit
  • the implantable neural stimulator 1 of the present invention is configured with parameters by the external energy controller, and is activated and started to work by the external energy controller. Once activated, the implantable neurostimulator 1 starts to operate actively depending on the configured parameters, and completes the electrode pulse stimulation therapy for the patient.
  • the implantable neural stimulator 1 since the implantable neural stimulator 1 itself has a rectifier energy storage circuit 13 , the electrical energy stored in the rectified energy storage circuit 13 supplies the entire implantable neural stimulator 1 to operate. At the same time, the rectifier energy storage circuit 13 receives the radio frequency electric energy of the external energy controller 2 for charging, so as to maintain the continuous operation of the implantable nerve stimulator 1 . The amount of electrical energy stored in the rectified tank circuit 13 can be monitored by the pre-measurement circuit. When the electrical energy storage capacity decreases, the implantable neural stimulator 1 will send an instruction to the external energy controller 2, and the external energy controller 2 will increase the transmission power. Therefore, the implantable neurostimulator 1 can be supplied with stable power.
  • the electrical pulse stimulation is implemented based on the combination of treatment parameters stored in the main control memory of the implantable neurostimulator 1, only the external energy controller needs to provide radio frequency electric energy, There is no need to obtain real-time stimulation signals containing stimulating electrical pulses from an external energy controller. Therefore, even if the communication is interrupted or the communication is poor due to an emergency, the treatment will not fail.
  • the implantable neurostimulator system of the present invention since the implantable neurostimulator itself has an energy storage circuit, the radio frequency electric energy received from the external energy controller can be stored, so even if the communication is interrupted due to an emergency If the radio frequency power supply is interrupted for a short time due to poor communication, the implantable neurostimulator of the present invention can also continue to operate for a period of time until the communication returns to normal, so that the treatment will not be interrupted.
  • the memory of the implantable neural stimulator can store various operating parameters, and can send these data to the external controller during the treatment interval or when the communication is not busy, therefore
  • the implantable nerve stimulator of the present invention can further ensure smooth communication when communication is required, thereby improving the performance of the device. For example, while the doctor or patient operates the external energy controller to send instructions to the implantable neurostimulator, the implantable neurostimulator will not send data to the outside to ensure smooth communication.

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Abstract

本发明公开了一种植入式神经刺激器系统。该植入式神经刺激器系统的体外能控器通过射频方式对植入式神经刺激器传输电能并与之通讯，包括：输入装置，体外能控器通过该输入装置接收信息；天线模块，天线模块与植入式神经刺激器的刺激器天线进行射频耦合；显示装置，用于显示数据、指令和输入信息；存储单元，其存储体运行程序、输入信息和数据；以及控制单元，所述控制单元分别连接输入装置、天线模块和显示装置，从而控制整个体外能控器的运行。本发明的神经刺激系统能够克服因短时通讯中断而导致的治疗失败，并使植入式神经刺激器获得稳定的供电。

Description

植入式神经刺激器系统 技术领域
本发明涉及植入式神经刺激系统，包括体外能控器和对应的植入式神经刺激器。本发明还涉及上述体外能控器。
背景技术
包含有植入式神经刺激器的神经刺激系统已经在医疗领域广为应用。在这种系统中，植入式神经刺激器被植入到患者体内，以实现对病患部位的治疗。
传统的植入式神经刺激器需要自带电池供电。当电池电量耗尽后，就需要取出植入患者体内的神经刺激器，以便重新安装电池。此外，当医生需要更改治疗方案时，也需要取出植入患者体内的神经刺激器，以便重新配置治疗方案。所述治疗方案包括例如刺激脉冲的脉宽、频率等。这对于治疗周期较长的患者而言无疑是痛苦的。
为解决这种痛苦，已经出现了基于射频控制的神经刺激系统。中国发明专利CN104080509B和CN107789730B就公开了这样的神经刺激器系统。其中的植入式神经刺激器与体外能控器进行射频通讯和能量传输，由体外能控器实时提供电刺激脉冲来驱动植入式神经刺激器的刺激电极，从而向患者的治疗部位施加刺激信号；并由体外能控器向植入式神经刺激器提供射频电能，来维持植入式神经刺激器的运行。
相比于以往的植入式神经刺激系统，基于射频的神经刺激器可以获得无限的电能供应，因此无需担心电池耗尽的问题。而且，这种基于射频的植入式神经刺激器，可以根据治疗方案由体外能控器随时调整电刺激脉冲。因此无需担心因电池耗尽和更改治疗方案所导致的反复植入问题。
然而现有技术的这种基于射频的神经刺激系统还存在着诸多缺陷：
由于体外能控器要同时对植入式神经刺激器提供电能和输入信号(例如各种刺激脉冲序列)，还需要实时监控植入式神经刺激器的工作 状态，可能导致无法实现对植入式神经刺激器的实时操作，这也对治疗过程产生不利影响。为解决这问题，CN107789730B采用了双频率工作模式，这样做的代价是增加了产品的复杂程度和制造成本，且可能导致植入式神经刺激器的体积增大。而这种体积增大显然不利于神经刺激器的植入。
此外，由于植入式神经刺激器的电刺激脉冲由体外能控器实时提供，因此必须确保植入患者体内的神经刺激器与体外能控器之间的可靠通讯。而这种通讯的可靠性会受到诸多因素的影响。例如，当体外能控器因某种因素远离患者时，或者当体外能控器受到意外冲击或受损时，哪怕是非常短的时间，都会对植入式神经刺激器的治疗过程产生不利的影响。
公开于本发明背景部分的信息仅仅旨在增加对本发明的总体背景的理解，而不应当被视为承认或以任何形式暗示该信息构成已为本领域一般技术人员所公知的现有技术。
发明内容
本发明的目的是提供一种神经刺激系统的体外能控器，其通过射频通讯与植入式神经刺激器一起构成神经刺激系统。该神经刺激系统还可以包括上位机软件，以方便操作设置。其特点是，植入式神经刺激器的运行控制不是由体外能控器来完成，而是由植入式神经刺激器中自带的主控芯片来实现的；体外能控器用于配置植入式神经刺激器的临床治疗参数和存储来自植入式神经刺激器的运行数据，并响应植入式神经刺激器的指令来调整发射功率。由此克服现有技术的植入式神经刺激器系统因需要实时通讯所带来的治疗安全性问题和产品复杂性问题。
本发明提供一种植入式神经刺激器系统，包括植入式神经刺激器和体外能控器，所述植入式神经刺激器具有刺激器天线模块，所述体外能控器具有能控器天线模块，通过所述刺激器天线模块和所述能控器天线模块，所述植入式神经刺激器以射频方式与体外能控器进行通讯并接收电能，其中所述植入式神经刺激器具有主控CPU、主控存储器和刺激电极，所述主控存储器用于存储包含临床刺激参数的控制信 息，所述主控CPU利用所述临床刺激参数主动地产生刺激脉冲序列并将刺激脉冲序列施加至刺激电极。
根据本发明的植入式神经刺激器系统，优选地，所述植入式神经刺激器还包括整流储能电路和前置测量反馈电路，所述整流储能电路用于储存所接收的电能，所述前置测量反馈电路用于测量所述整流储能电路中的电能储存量，当所述电能储存量不足时，所述主控CPU向体外能控器发送功率调整指令，所述体外能控器根据接收到的功率调整指令调节体外能控器的发射功率。
根据本发明的植入式神经刺激器系统，优选地，所述植入式神经刺激器还包括后置测量反馈电路，所述后置测量反馈电路用于测量刺激电极上的实时刺激参数并传输给所述主控CPU，所述主控CPU将所述实时刺激参数存储在所述主控存储器中，并定时将所述实时刺激参数发送给体外能控器，或响应数据读取指令将所述实时刺激参数发送给体外能控器；所述体外能控器包括存储单元，从而储存从植入式神经刺激器接收到的实时刺激参数。
根据本发明的植入式神经刺激器系统，优选地，所述体外能控器还包括输入装置、显示装置和电源；所述输入装置和所述显示装置用于实现人机交互，以便对植入式神经刺激器发送所述控制信息；所述控制信息包括修改临床刺激参数的指令。
根据本发明的植入式神经刺激器系统，优选地，所述控制信息还包括加减档指令，以便根据需要调整所述刺激脉冲序列的刺激强度。
根据本发明的植入式神经刺激器系统，优选地，其中所述体外能控器还包括存储单元，其存储体外能控器的运行程序、从输入装置输入的信息以及从植入式神经刺激器接收的数据；
所述控制信息还包括所述数据读取指令，以便随时从植入式神经刺激器读取包括实时刺激参数在内的运行数据。
根据本发明的植入式神经刺激器系统，优选地，植入式神经刺激器系统还包括作为控制和信息处理平台的上位机，所述体外能控器还包括上位机通讯模块，所述上位机通过所述上位机通讯模块与所述体外能控器进行通讯，从而通过体外能控器向所述植入式神经刺激器发送指令，或从所述体外能控器读取数据。
根据本发明的植入式神经刺激器系统，优选地，其中所述上位机通讯模块为诸如蓝牙的无线通讯模块。
根据本发明的植入式神经刺激器系统，优选地，其中所述上位机具有上位机软件，用户可通过所述上位机软件向神经刺激系统的体外能控器发送指令，从而对神经刺激系统的体外能控器进行操作，或通过所述神经刺激系统的体外能控器对植入式神经刺激器进行操作，所述操作包括对临床刺激参数进行设定、测量、编程、数据管理，所述数据管理涉及的数据包含神经刺激系统的体外能控器和植入式神经刺激器运行时产生的可测量的相关参数、修正数据和观察变量。
根据本发明的植入式神经刺激器系统，优选地，其中所述上位机软件能够操作所述上位机来连接网络或内部服务器，以进行程序和数据的备份、更新。
本发明的植入式神经刺激器系统可实现如下有益技术效果：
由于基于存储在植入式神经刺激器的主控存储器中的治疗参数组合实施电脉冲刺激，因此只需要由体外能控器提供射频电能，而无需从体外能控器获得实时的包含刺激电脉冲的刺激信号，因此提高了植入式神经刺激器运行的可靠性，不必担心因突发的通讯中断或通讯不畅而导致的治疗失败。
由于植入式神经刺激器自身带有储能电路，因此在突发的通讯中断或通讯不畅的情况下也能保证短时间内的电能供应，而不至于使治疗中断。
由于植入式神经刺激器的存储器能存储各种运行参数，并可以治疗间歇期或通讯不繁忙时向体外能控器发送这些数据，因此可以进一步保证在需要通讯时畅通的畅通，从而改善设备的性能。
本发明的方法和装置具有其他的特性和优点，这些特性和优点从并入本文中的附图和随后的具体实施方式中将是显而易见的，或者将在并入本文中的附图和随后的具体实施方式中进行详细陈述，这些附图和具体实施方式共同用于解释本发明的特定原理。
附图说明
图1示出了包含有本发明的体外能控器的神经刺激系统的一个实 施方案的原理框图。
图2示出了包含有本发明的体外能控器的神经刺激系统的另一个实施方案的原理框图。
图3示出了本发明的神经刺激系统的体外能控器的原理框图。
图4示出了本发明的植入式神经刺激器系统中的植入式神经刺激器的原理框图。
图5示出了本发明的植入式神经刺激器系统中的另一种植入式神经刺激器的原理框图。
应当了解，附图并不必须是按比例绘制的，其示出了某种程度上经过简化了的本发明的基本原理的各个特征。在此所公开的本发明的特定的设计特征，包括例如特定的尺寸、定向、定位和外形，将部分地由特定目的的应用和使用环境所确定。
在这些附图中，在贯穿附图的多幅图形中，附图标记指代本发明的相同或等效的部分。
具体实施方式
现在将具体参考本发明的各个实施例，在附图中和以下的描述中示出了这些实施例的实例。虽然本发明与示例性实施例相结合进行描述，但是应当了解，本说明书并非旨在将本发明限制为那些示例性实施例。相反，本发明旨在不但覆盖这些示例性实施例，而且覆盖可以被包括在由所附权利要求所限定的本发明的精神和范围之内的各种替换、修改、等效形式以及其它实施例。
图1示出了包含有本发明的体外能控器的神经刺激系统的一个实施方案的原理框图。如图1所示，该神经刺激系统包括植入式神经刺激器1、体外能控器2两个部分。
图2示出了包含有本发明的体外能控器的神经刺激系统的另一个实施方案的原理框图。相比于图1中的实施方案，图2的中的实施方案增加了上位机3。上位机不是必须的。增加上位机有助于改善人机交互功能，使得医生或患者可以更方便地操作神经刺激系统，也便于为神经刺激系统设置更加复杂的功能。
图3示出了本发明的神经刺激系统的体外能控器的原理框图。
如图1、图2所示，本发明的神经刺激系统的体外能控器2，通过射频方式对植入式神经刺激器1传输电能并与之通讯。如图3所示，本发明的神经刺激系统的体外能控器2包括：输入装置20，体外能控器2通过输入装置20接收信息；天线模块21，天线模块21与植入式神经刺激器1的刺激器天线进行射频耦合，从而向植入式神经刺激器1发送包含电能和控制信息的输入信号，并能从植入式神经刺激器1接收指令和数据；显示装置22，所述显示装置22显示体外能控器2的当前状态以及从输入装置20输入的信息，还显示从植入式神经刺激器1接收的数据和指令；存储单元23，其存储体外能控器2的运行程序、从输入装置20输入的信息以及从植入式神经刺激器1接收的数据；电源24，用于为整个神经刺激系统的体外能控器供电；以及控制单元25，所述控制单元控制分别连接输入装置20、天线模块21、电源24和显示装置22，从而控制整个体外能控器2的运行。
用户可以操作输入装置。从输入装置20输入的信息可以包括配置体外能控器2的信息、配置植入式神经刺激器1的信息，以及向植入式神经刺激器1读取数据的指令。此外，通过操作输入装置20，还可以显示体外能控器2本身的任何信息，包括存储单元23中存储的信息(例如来自植入式神经刺激器1的运行数据)。
输入装置20可以为按键、手写屏、语音输入麦克风等任何能够适合输入信息的装置。优选地，所述输入装置20具有刺激强度调节单元，能够以加减档的方式调节植入式神经刺激器1的刺激强度。所述刺激强度调节单元可以为加减档按键，或者屏幕显示虚拟按键。
显示装置22可以为液晶显示屏、LED显示器等任何能够显示信息的装置。
存储单元23优选为非易失性存储器，以便即使在断电后也能存储数据。这样，只需针对每个患者在每个治疗阶段开始前根据治疗方案对神经刺激系统的体外能控器2进行配置，即可适用于整个治疗阶段。因此，避免了需要医生对神经刺激系统的体外能控器2进行频繁的设置。
电源24可以为普通电池，也可以为充电电池。
上述从植入式神经刺激器1接收的指令为调整体外能控器的发射 功率的指令，所述控制单元25根据该指令调整天线模块21的发射功率，以符合植入式神经刺激器1的运行需求。这种根据植入式神经刺激器1的运行需求来调整发射功率的方式，显然更有助于保证植入式神经刺激器1的可靠运行。
本发明的神经刺激系统的体外能控器2还可具有从上位机3接收指令和向上位机3发送数据的上位机通讯模块26，该指令对用于来神经刺激系统的体外能控器2进行配置或者对植入式神经刺激器2进行配置；或者用于将所述神经刺激系统的体外能控器2的各种数据以及来自植入式神经刺激器1的数据传输给所述上位机3。
上位机3可具有专用的上位机软件，用户可通过上位机软件向神经刺激系统的体外能控器2发送指令，从而对神经刺激系统的体外能控器2进行操作，或通过所述神经刺激系统的体外能控器2对植入式神经刺激器1进行操作，所述操作包括对临床刺激参数进行设定、测量、编程、数据管理。
上位机软件还可以操作上位机3来连接网络或内部服务器以进行程序和数据的备份、更新。
显然，上位机3及所包含的上位机软件可以提高操作的便利性，且有助于设置更加复杂的治疗方案。
本发明的神经刺激系统的体外能控器2的上位机通讯模块26可以为无线通讯模块，从而以无限通讯方式与所述上位机3进行命令和数据交换。显然，无限通讯方式可以使神经刺激系统的体外能控器2和上位机3之间的连接更加方便，从而提高操作的便利性和产品设计的简洁性。
上述的无线通讯模块可以为蓝牙模块。
本发明的神经刺激系统的体外能控器2常常设计成随身佩戴的形式，以便于能够随着患者运动到任何地方。这种随身佩戴的设计需要尽量降低产品的尺寸，因此其电池尺寸也会尽量减小，这就需要充分考虑装置的节能设计。蓝牙通讯具有低功耗的特点，能够很好地满足这种节能需求。
植入式神经刺激器1作为一种体内治疗设备，需要很高的安全性。即，要防止非法的操作者或非法体外控制设备干扰植入式神经刺激器 1。蓝牙还提供两层密码保护，可以比较有效地防范这种非法侵入风险。
作为选择，上述无线通讯模块还可以为WIFI模块。根据治疗方案的不同，某些治疗方案可能产生大量的数据。这就增加了需要传输的数据量。WIFI通讯具有传输速度快，有助于满足这种需求。
本发明的神经刺激系统的体外能控器2，由于无需向植入式神经刺激器1发送实时的包含刺激电脉冲的刺激信号，而只需要提供射频电能，因此即使因突发事件导致通讯中断或通讯不畅也不会导致治疗失败。
由于植入式神经刺激器1能够在治疗间歇期或通讯不繁忙时向体外能控器发送这些数据，因此本发明的神经刺激系统的体外能控器2可以进一步保证在需要通讯时保持通讯畅通，从而改善设备的性能。例如，在医生或患者操作体外能控器对植入式神经刺激器发送指令的同时，植入式神经刺激器不会向外发送数据，以确保通讯的畅通。
本发明的神经刺激系统的体外能控器2，由于从植入式神经刺激器接收调整发射功率的指令，并响应该指令调整天线模块的发射功率，因此可以使植入式神经刺激器1得到稳定的电力供应。
如以上的图1所示，本发明的植入式神经刺激器系统，包括植入式神经刺激器1与体外能控器2，所述植入式神经刺激器1通过射频方式与体外能控器2进行通讯并接收电能，其中所述植入式神经刺激器具有主控CPU、主控存储器和刺激电极，所述主控存储器用于存储包含临床刺激参数的控制信息，所述主控CPU利用所述临床刺激参数主动地产生刺激脉冲序列并将刺激脉冲序列施加至刺激电极。
在上述植入式神经刺激器系统中，所述植入式神经刺激器1还包括整流储能电路和前置测量反馈电路，所述整流储能电路用于储存所接收的电能，所述前置测量反馈电路用于测量所述整流储能电路中的电能储存量，当所述电能储存量不足时，所述主控CPU向体外能控器发送功率调整指令，从而调整体外能控器的发射功率。
在上述植入式神经刺激器系统中，所述植入式神经刺激器1还包括后置测量反馈电路，所述后置测量反馈电路用于测量刺激电极上的实时刺激参数并传输给所述主控CPU，所述主控CPU将所述实时刺激参数存储在所述主控存储器中，并定时将所述实时刺激参数发送给体 外能控器，或响应数据读取指令将所述实时刺激参数发送给体外能控器；所述体外能控器包括存储单元，从而储存从植入式神经刺激器接收到的实时刺激参数。
在上述植入式神经刺激器系统中，体外能控器2还包括输入装置、显示装置和电源；所述输入装置和所述显示装置用于实现人机交互，以便向植入式神经刺激器发送所述控制信息；所述控制信息包括临时修改临床刺激参数的指令，在系统重启后，所临时修改的临床刺激参数将恢复为原设定值。
在上述植入式神经刺激器系统中，所述控制信息还包括加减档指令，以便根据需要调整所述刺激脉冲序列的刺激强度。
在上述植入式神经刺激器系统中，所述控制信息还包括所述数据读取指令，以便随时从植入式神经刺激器读取包括实时刺激参数在内的运行数据。
图2示出了包含有本发明的植入式神经刺激器系统的另一个实施方案的原理框图。相比于图1中的实施方案，图2的中的实施方案增加了上位机3。上位机不是必须的。增加上位机有助于改善人机交互功能，使得医生或患者可以更方便地操作神经刺激系统，也便于为神经刺激系统设置更加复杂的功能。
在图2示出的本发明的植入式神经刺激器系统中，增加了作为控制和信息处理平台的上位机，所述体外能控器还包括上位机通讯模块，所述上位机通过所述上位机通讯模块与所述体外能控器进行通讯，从而通过体外能控器向所述植入式神经刺激器发送指令，或读取所述体外能控器中存储的数据。
上述上位机通讯模块可以为无线通讯模块，例如蓝牙通讯模块，以使通讯连接更加方便。上述上位机还可以具有数据分析管理系统，用于分析并管理从体外能控器读取的数据，从而有助于指定和修改临床刺激参数组合。
图4示出了本发明的神经刺激系统中的植入式神经刺激器的原理框图。
如图4所示，本发明的植入式神经刺激器1，其通过射频方式与体外能控器进行通讯和接收电能，包括：主控芯片11，所述主控芯片包 括主控CPU 111、主控存储器112和数模转换电流源电路(i-DAC)113；刺激器天线及其阻抗匹配电路12，其与体外能控器射频耦合，以从体外能控器接收包含有电能和控制信息的输入信号，并能够向体外能控器发送数据；整流储能电路13，其分别连接至所述阻抗匹配电路12和所述主控芯片11，以便从所接收的输入信号中提取电能并存储电能，并对所述主控芯片11供电；调制/解调电路14，其连接至所述阻抗匹配电路12和所述主控芯片11，以便从所接收的输入信号中提取控制信息，并将控制信息传输给主控芯片11，且对主控芯片11发送的数据进行调制后传输给阻抗匹配电路，并通过刺激器天线发送给体外能控器；电极接口15，其连接至所述主控芯片11，并从主控芯片11接收极性分配信息，并从数模转换电流源电路113接收刺激脉冲序列；一个或多个刺激电极16，其连接至所述电极接口15，所述电极接口根据极性分配信息将所述刺激脉冲序列分配给各对应的刺激电极16；其中所述主控存储器112存储有控制程序，并存储所接收的所述控制信息，所述主控CPU运行所述控制程序控制所述数模转换电流源电路113根据所述控制信息产生所述刺激脉冲序列，所述控制信息包括临床刺激参数组合，所述临床刺激参数组合为极性分配信息参数、脉冲宽度参数、脉冲幅值参数和脉冲频率参数的参数组合。
主控存储器112优选为非易失性存储器，以便即使在断电后也能存储数据。这样，只需针对每个患者在每个治疗阶段开始前根据治疗方案对植入式神经刺激器1进行配置，即可适用于整个治疗阶段。因此，避免了需要医生对植入式神经刺激器1进行频繁的设置。
所述临床刺激参数组合可以包括多组，每组临床刺激参数组合具有各自的代码，所述控制信息还包括临床刺激参数代码，所述临床刺激参数代码与所述主控存储器储存的多组临床刺激参数组合的代码一一对应。这样，用户(医生或患者)可以根据治疗的进程，操作体外能控器直接调用相应的治疗方案(对应于相应的临床刺激参数组合)。避免了随着患者病情的改善而需频繁地配置植入式神经刺激器的麻烦。
上述的控制信息还包括加减档控制指令，所述主控芯片11响应所述加减档控制指令以步进的方式调节刺激脉冲序列的脉冲强度。这样， 患者可根据自身的体验，随时调整刺激的强度。在植入式神经刺激器1中，所述控制信息还包括数据读取指令，所述主控CPU响应数据读取指令而将主控存储器中存储的相应数据发送给体外能控器2。由此，患者或医生可以获得植入式神经刺激器1中存储的各种治疗参数组合，也可以获得植入式神经刺激器1运行产生的数据。
植入式神经刺激器采用刺激脉冲序列来对患者进行治疗。当脉冲频率较高时，相邻的刺激脉冲之间的电荷无法得到充分的释放，由此使得实际的脉冲波形序列与治疗所需的脉冲波形序列有所不同。这将影响治疗效果，而且还会降低到植入式神经刺激器本身的使用寿命。
在植入式神经刺激器1中，所述临床刺激参数组合的参数还包括电荷平衡时间，所述电荷平衡时间的长度足以保证相邻的电刺激脉冲之间的电荷得到充分释放，从而实现被动电荷平衡。由此克服了现有的神经刺激器存在的相邻的电刺激脉冲之间的电荷得不到释放的问题。
如图4所示，在植入式神经刺激器1中，在电极接口15和主控芯片11的数模转换电流源电路113之间还连接有电荷平衡电路17，所述电荷平衡电路17能够在相邻的电刺激脉冲之间对电极接口15施加反向脉冲，从而实现主动电荷平衡。相比于自然放电的被动电荷平衡，主动电荷平衡可以更快地完成放电过程。显然，这种主动电荷平衡允许采用更高的刺激脉冲频率。反过来说，电荷平衡电路17并非是必须的，这取决于植入式神经刺激器1所采用的刺激脉冲的频率。
如图4所示，在植入式神经刺激器1中，还包括运行数据存储器18，用于存储植入式神经刺激器运行中产生的各种运行数据。从体外能控器接收的控制信息还包括数据读取指令，主控CPU 111响应数据读取指令而将运行数据存储器18中存储的数据发送给体外能控器2。
需要说明的是，运行数据存储器18并不是必须的，植入式神经刺激器运行中产生的各种运行数据也可以存储在主控存储器112的某个分区中，只要主控存储器的存储容量足够大即可。运行数据存储器18优选为非易失性存储器，以便即使在断电后也能存储数据。这样，在存储空间允许的范围内，体外能控器可以在一段时间内根据需要调取植入式神经刺激器的运行数据。也防止了数据因突然通讯中断而丢失。
如图4所示，在植入式神经刺激器1中，还包括后置测量反馈电路19，所述后置测量反馈电路19分别连接所述电极接口15和所述主控芯片11，以便测量刺激电极16上的实时刺激参数并传输给所述主控芯片11，所述主控芯片将所述实时刺激参数存储在所述运行数据存储器18中。
主控芯片11可以将所述实时刺激参数与所存储的临床刺激参数进行比对，并根据比对结果修正施加至各刺激电极上的刺激信号。
需要说明的是，后置测量反馈电路并非是必须的。作为简化配置，可以将植入式神经刺激器设计成某种简单可靠的工作模式，无需对刺激电极的工作参数进行测量。这样做有助于降低成本。
在图4所示的植入式神经刺激器1中，还包括前置测量反馈电路10，所述前置测量反馈电路10设置在所述整流储能电路13和所述主控芯片11之间，以便随时测量所述整流储能电路13中的实时电能储存量并传输给所述主控芯片11，所述主控芯片将所述实时电能储存量存储在所述运行数据存储器18中。
主控芯片11根据所述实时电能储存量，评估是否需要调整射频输入的电能，当所述实时电能储存量低于设定值时，所述主控芯片11通过刺激器天线及其阻抗匹配电路12向体外能控器2的天线发送功率调整指令，从而调整体外能控器2的发射功率。
如以上所述，本发明的植入式神经刺激器1具有主控存储器和运行数据存储器。作为数据管理措施，主控芯片11可以主动向体外能控器发送数据，即，定期将主控存储器和/运行数据存储器存储的各种数据向体外能控器发送。
在图4所示的植入式神经刺激器的原理框图中，主控芯片11只包括主控CPU 111、主控存储器112和数模转换电流源电路(i-DAC)113，其中电路部分作为外围电路。
当然，出于提高集成度缩小体积与工艺成本的平衡考虑，也可以将前置测量反馈电路、调制/解调电路、电极接口、电荷平衡电路、运行数据存储器和后置测量反馈电路中的一部分或全部都设计在主控芯片11中。例如，在图5所示的另一种植入式神经刺激器的原理框图中，主控芯片11就包括主控CPU 111、主控存储器112和数模转换电流源 电路(i-DAC)113、前置测量反馈电路110、调制/解调电路114、电极接口115、电荷平衡电路117、运行数据存储器118和后置测量反馈电路119。
综上所述，本发明的植入式神经刺激器1由体外能控器配置参数，并由体外能控器启动开始工作。一旦启动之后，植入式神经刺激器1就开始依靠配置好的参数主动运行，完成对患者的电极脉冲刺激治疗。
在本发明的植入式神经刺激器系统中，由于植入式神经刺激器1自身带有整流储能电路13，整流储能电路13所存储的电能供应整个植入式神经刺激器1运行。同时，整流储能电路13接收体外能控器2的射频电能进行充电，以维持植入式神经刺激器1的持续运行。可由前置测量电路监控整流储能电路13的电能的存储量。在电能存储量下降时，植入式神经刺激器1会向体外能控器2发送指令，由体外能控器2提高发射功率。因此可以使植入式神经刺激器1得到稳定的电力供应。
在本发明的植入式神经刺激器系统中，由于基于存储在植入式神经刺激器1的主控存储器中的治疗参数组合实施电脉冲刺激，因此只需要由体外能控器提供射频电能，而无需从体外能控器获得实时的包含刺激电脉冲的刺激信号。因此即使因突发事件导致通讯中断或通讯不畅，也不会导致治疗失败。
在本发明的植入式神经刺激器系统中，由于植入式神经刺激器自身带有储能电路，可将从体外能控器接收的射频电能存储起来，因此即使因突发事件导致通讯中断或通讯不畅而导致射频供电短时间中断，本发明的植入式神经刺激器也能够继续运行一段时间直至通讯恢复正常，因此不至于使治疗中断。
在本发明的植入式神经刺激器系统中，由于植入式神经刺激器的存储器能存储各种运行参数，并可以在治疗间歇期或通讯不繁忙时向体外能控器发送这些数据，因此本发明的植入式神经刺激器可以进一步保证在需要通讯时通讯的畅通，从而改善设备的性能。例如，在医生或患者操作体外能控器对植入式神经刺激器发送指令的同时，植入式神经刺激器不会向外发送数据，以确保通讯的畅通。
前述对本发明的具体示例性实施方案的描述是为了说明和例证的目的。这些描述并非想穷尽本发明，或者将本发明限定为所公开的精 确形式，并且很显然，根据上述教导，可以进行很多改变和变化。对示例性实施例进行选择和描述的目的在于解释本发明的特定原理及其实际应用，从而使得本领域的其它技术人员能够实现并利用本发明的各种不同的示例性实施方案以及各种不同的选择和改变。本发明的范围意在由所附的权利要求书及其等同形式所限定。

Claims (10)

  1. 一种植入式神经刺激器系统，包括植入式神经刺激器和体外能控器，所述植入式神经刺激器具有刺激器天线模块，所述体外能控器具有能控器天线模块，通过所述刺激器天线模块和所述能控器天线模块，所述植入式神经刺激器以射频方式与体外能控器进行通讯并接收电能，其中所述植入式神经刺激器具有主控CPU、主控存储器和刺激电极，所述主控存储器用于存储包含临床刺激参数的控制信息，所述主控CPU利用所述临床刺激参数主动地产生刺激脉冲序列并将刺激脉冲序列施加至刺激电极。
  2. 根据权利要求1所述的植入式神经刺激器系统，其中所述植入式神经刺激器还包括整流储能电路和前置测量反馈电路，所述整流储能电路用于储存所接收的电能，所述前置测量反馈电路用于测量所述整流储能电路中的电能储存量，当所述电能储存量不足时，所述主控CPU向体外能控器发送功率调整指令，所述体外能控器根据接收到的功率调整指令调节体外能控器的发射功率。
  3. 根据权利要求1所述的植入式神经刺激器系统，其中所述植入式神经刺激器还包括后置测量反馈电路，所述后置测量反馈电路用于测量刺激电极上的实时刺激参数并传输给所述主控CPU，所述主控CPU将所述实时刺激参数存储在所述主控存储器中，并定时将所述实时刺激参数发送给体外能控器，或响应数据读取指令将所述实时刺激参数发送给体外能控器；所述体外能控器包括存储单元，从而储存从植入式神经刺激器接收到的实时刺激参数。
  4. 根据权利要求3所述的植入式神经刺激器系统，其中所述体外能控器还包括输入装置、显示装置和电源；所述输入装置和所述显示装置用于实现人机交互，以便对植入式神经刺激器发送所述控制信息；所述控制信息包括修改临床刺激参数的指令。
  5. 根据权利要求4所述的植入式神经刺激器系统，其中所述控制信息还包括加减档指令，以便根据需要调整所述刺激脉冲序列的刺激强度。
  6. 根据权利要求4或5所述的植入式神经刺激器系统，其中所述体外能控器还包括存储单元，其存储体外能控器的运行程序、从输入装置输入的信息以及从植入式神经刺激器接收的数据；
    所述控制信息还包括所述数据读取指令，以便随时从植入式神经刺激器读取包括实时刺激参数在内的运行数据。
  7. 根据权利要求3所述的植入式神经刺激器系统，所述植入式神经刺激器系统还包括作为控制和信息处理平台的上位机，所述体外能控器还包括上位机通讯模块，所述上位机通过所述上位机通讯模块与所述体外能控器进行通讯，从而通过体外能控器向所述植入式神经刺激器发送指令，或从所述体外能控器读取数据。
  8. 根据权利要求7所述的植入式神经刺激器系统，其中所述上位机通讯模块为诸如蓝牙的无线通讯模块。
  9. 根据权利要求7所述的植入式神经刺激器系统，其中所述上位机具有上位机软件，用户可通过所述上位机软件向神经刺激系统的体外能控器发送指令，从而对神经刺激系统的体外能控器进行操作，或通过所述神经刺激系统的体外能控器对植入式神经刺激器进行操作，所述操作包括对临床刺激参数进行设定、测量、编程、数据管理，所述数据管理涉及的数据包含神经刺激系统的体外能控器和植入式神经刺激器运行时产生的可测量的相关参数、修正数据和观察变量。
  10. 根据权利要求9所述的植入式神经刺激器系统，其中所述上位机软件能够操作所述上位机来连接网络或内部服务器，以进行程序和数据的备份、更新。
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