CN113274640A

CN113274640A - Implantable neurostimulator system

Info

Publication number: CN113274640A
Application number: CN202110412431.9A
Authority: CN
Inventors: 徐天睿
Original assignee: Beijing Lingchuang Yigu Technology Development Co ltd
Current assignee: Beijing Lingchuang Yigu Technology Development Co ltd
Priority date: 2021-04-16
Filing date: 2021-04-16
Publication date: 2021-08-20

Abstract

An implantable neurostimulator system comprises an implantable neurostimulator and an external energy controller, wherein the implantable neurostimulator is communicated with the external energy controller in a radio frequency mode and receives electric energy, the implantable neurostimulator is provided with a main control CPU, a main control memory and a stimulation electrode, the main control memory is used for storing control information containing clinical stimulation parameters, and the main control CPU actively generates stimulation pulse sequences by utilizing the clinical stimulation parameters and applies the stimulation pulse sequences to the stimulation electrode. Because the electric pulse stimulation is implemented based on the treatment parameter combination stored in the implanted nerve stimulator, only the radio frequency electric energy is provided by the external energy controller, thereby improving the operation reliability of the implanted nerve stimulator. Because the implanted nerve stimulator is provided with the energy storage circuit, the electric energy supply in a short time can be ensured under the condition of sudden communication interruption or unsmooth communication, and the treatment can not be interrupted.

Description

Implantable neurostimulator system

Technical Field

The invention relates to an implanted nerve stimulator system, which comprises an implanted nerve stimulator and an external energy controller, wherein the implanted nerve stimulator and the external energy controller form the nerve stimulator system through radio frequency communication between the implanted nerve stimulator and the external energy controller.

Background

Neurostimulation systems incorporating implantable neurostimulators have become widely used in the medical field. In such systems, an implantable neurostimulator is implanted within a patient to effect treatment of the affected site.

Conventional implantable neurostimulators require their own battery to supply power. When the battery is depleted, the neurostimulator implanted in the patient needs to be removed in order to reinstall the battery. In addition, when a physician needs to change the treatment plan, the neurostimulator implanted in the patient also needs to be removed in order to reconfigure the treatment plan. The treatment regimen includes, for example, the pulse width, frequency, etc. of the stimulation pulses. This is clearly painful for patients with long treatment periods.

To address this pain, implantable neurostimulation systems based on radio frequency control have emerged. Chinese invention patents CN104080509B and CN107789730B disclose such neurostimulator systems. The external energy controller provides electrical stimulation pulses in real time to drive a stimulation electrode of the implantable nerve stimulator so as to apply stimulation signals to a treatment part of a patient; and the external energy controller provides radio frequency electric energy to the implanted nerve stimulator to maintain the operation of the implanted nerve stimulator.

Compared with the traditional implantable neurostimulation system, the radio frequency-based neurostimulator can obtain almost endless electric energy supply, so that the problem of battery exhaustion is not needed to be worried about. Moreover, the radio frequency-based implantable neural stimulator can adjust the electrical stimulation pulse at any time by the external energy controller according to the treatment scheme. There is no concern about repeated implantation problems due to battery depletion and changing treatment regimens.

However, there are many drawbacks to such prior art radio frequency based neurostimulation systems.

Since the external energy controller needs to provide the electrical energy and the input signal (such as various stimulation pulse sequences) to the implantable neurostimulator at the same time, and needs to monitor the working state of the implantable neurostimulator in real time, it may not be able to implement the real-time operation of the implantable neurostimulator, which also has an adverse effect on the treatment process. To solve this problem, CN107789730B adopts a dual-frequency operation mode, which increases the complexity and manufacturing cost of the product and may result in an increase in the volume of the implantable neurostimulator. This increase in volume is clearly detrimental to the implantation of the neurostimulator.

In addition, since the electrical stimulation pulses of the implantable neurostimulator are provided by the external energy controller in real time, reliable communication between the neurostimulator implanted in the patient and the external energy controller must be ensured. The reliability of such communications can be affected by a number of factors. For example, even a very short period of time when the external energy controller is away from the patient by some factor or when the external energy controller is accidentally impacted or damaged, the therapeutic process of the implantable neurostimulator can be adversely affected.

The information disclosed in this background section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person skilled in the art.

Disclosure of Invention

The invention aims to provide an implanted nerve stimulator system, which comprises an implanted nerve stimulator and an external energy controller, wherein the implanted nerve stimulator and the external energy controller form a nerve stimulation system through radio frequency communication between the implanted nerve stimulator and the external energy controller. The neurostimulation system may also include upper computer software to facilitate the set-up of the operation. The operation control of the implanted nerve stimulator is not completed by an external energy controller, but is realized by a main control chip carried by the implanted nerve stimulator. Therefore, the problems of treatment safety and product complexity caused by the need of real-time communication of the implanted nerve stimulator system in the prior art are solved.

The invention provides an implantable neural stimulator system, which comprises an implantable neural stimulator and an external energy controller, wherein the implantable neural stimulator is communicated with the external energy controller in a radio frequency mode and receives electric energy, the implantable neural stimulator is provided with a main control CPU, a main control memory and a stimulation electrode, the main control memory is used for storing control information containing clinical stimulation parameters, and the main control CPU actively generates a stimulation pulse sequence by utilizing the clinical stimulation parameters and applies the stimulation pulse sequence to the stimulation electrode.

In the above-mentioned implantable neurostimulator system of the present invention, preferably, the implantable neurostimulator further includes a rectifying energy storage circuit and a pre-measurement feedback circuit, the rectifying energy storage circuit is configured to store the received electric energy, the pre-measurement feedback circuit is configured to measure an electric energy storage amount in the rectifying energy storage circuit, and when the electric energy storage amount is insufficient, the main control CPU sends a power adjustment command to the external energy controller, so as to adjust the transmission power of the external energy controller.

In the above-mentioned implantable neurostimulator system of the present invention, preferably, the implantable neurostimulator further comprises a post-measurement feedback circuit, the post-measurement feedback circuit is configured to measure a real-time stimulation parameter on the stimulation electrode and transmit the real-time stimulation parameter to the main control CPU, and the main control CPU stores the real-time stimulation parameter in the main control memory and sends the real-time stimulation parameter to the external energy controller at regular time, or sends the real-time stimulation parameter to the external energy controller in response to a data reading instruction; the external energy controller includes a memory unit to store real-time stimulation parameters received from the implantable neural stimulator.

In the above-mentioned implantable neurostimulator system of the present invention, preferably, 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 for realizing human-computer interaction so as to send the control information to the implantable neural stimulator; the control information includes instructions to modify a clinical stimulation parameter.

In the above-mentioned implantable neurostimulator system of the present invention, preferably, the control information further comprises an upshift or downshift instruction so as to adjust the stimulation intensity of the stimulation pulse sequence as needed.

In the above-mentioned implantable neurostimulator system of the invention, preferably, the control information further comprises the data reading instruction, so as to read the operation data including the real-time stimulation parameters from the implantable neurostimulator at any time.

In the above-mentioned implantable neurostimulator system of the present invention, preferably, the system further comprises an upper computer as a control and information processing platform, and the external energy controller further comprises an upper computer communication module, and the upper computer communicates with the external energy controller through the upper computer communication module, so as to send an instruction to the external energy controller and to the implantable neurostimulator through the external energy controller, or read data from the external energy controller.

In the above-mentioned implantable neurostimulator system of the invention, preferably, the upper computer communication module is a wireless communication module such as bluetooth.

In the above-described implantable neurostimulator system of the present invention, the host computer preferably has a data analysis management system for analyzing and managing data read from the external energy controller, thereby facilitating specification and modification of the clinical stimulation parameter combination.

The implanted nerve stimulator system can realize the following beneficial technical effects:

because the electric pulse stimulation is implemented based on the treatment parameter combination stored in the main control memory of the implanted nerve stimulator, only the external energy controller is required to provide radio frequency electric energy, and a real-time stimulation signal containing stimulation electric pulses is not required to be obtained from the external energy controller, so the operation reliability of the implanted nerve stimulator is improved, and the treatment failure caused by sudden communication interruption or unsmooth communication is not necessary to worry.

Because the implanted nerve stimulator is provided with the energy storage circuit, the electric energy supply in a short time can be ensured under the condition of sudden communication interruption or unsmooth communication, and the treatment can not be interrupted.

The memory of the implanted nerve stimulator can store various operation parameters and can send the data to the external energy controller in the intermittent treatment period or in the busy communication period, so that the smoothness of communication can be further ensured when the communication is needed, and the performance of the equipment is improved.

The method and apparatus of the present invention have other features and advantages which will be apparent from or are set forth in detail in the accompanying drawings and the following detailed description, which are incorporated herein, and which together serve to explain certain principles of the invention.

Drawings

Figure 1 illustrates a functional block diagram of one embodiment of an implantable neurostimulator system of the present invention.

Fig. 2 illustrates a functional block diagram of another embodiment of an implantable neurostimulator system of the present invention.

Fig. 3 illustrates a functional block diagram of an implantable neurostimulator in an implantable neurostimulator system of the present invention.

Fig. 4 illustrates a functional block diagram of another implantable neurostimulator in the implantable neurostimulator system of the present invention.

Figure 5 illustrates a functional block diagram of an external energy controller in an implantable neurostimulator system of the present invention.

It is to be understood that the drawings are not necessarily to scale, illustrating features of the basic principles of the invention which are somewhat simplified. The specific design features of the invention disclosed herein, including, for example, specific dimensions, orientations, and configurations, will be determined in part by the particular intended application and use environment.

In the drawings, like or equivalent elements of the invention are designated with reference numerals throughout the several views of the drawings.

Detailed Description

Reference will now be made in detail to the various embodiments of the invention, examples of which are illustrated in the accompanying drawings and described below. While the invention is described in conjunction with the exemplary embodiments, it will be understood that this description is not intended to limit the invention to those exemplary embodiments. On the contrary, the invention is intended to cover not only these exemplary embodiments, but also various alternatives, modifications, equivalents and other embodiments, which may be included within the spirit and scope of the invention as defined by the appended claims.

[ implantable neural stimulator system ]

Figure 1 illustrates a functional block diagram of one embodiment of an implantable neurostimulator system incorporating the present invention. As shown in fig. 1, the neurostimulation system comprises an implantable neurostimulator 1 and an external energy controller 2.

The implantable neural stimulator system comprises an implantable neural stimulator 1 and an external energy controller 2, wherein the implantable neural stimulator 1 is communicated with the external energy controller 2 in a radio frequency mode and receives electric energy, the implantable neural stimulator is provided with a main control CPU, a main control memory and a stimulation electrode, the main control memory is used for storing control information containing clinical stimulation parameters, and the main control CPU actively generates stimulation pulse sequences by utilizing the clinical stimulation parameters and applies the stimulation pulse sequences to the stimulation electrode.

In the above-mentioned implantable neurostimulator system, the implantable neurostimulator 1 further comprises a rectification energy storage circuit and a pre-measurement feedback circuit, the rectification energy storage circuit is used for storing the received electric energy, the pre-measurement feedback circuit is used for measuring the electric energy storage amount in the rectification energy storage circuit, and when the electric energy storage amount is insufficient, the main control CPU sends a power adjustment instruction to the external energy controller, so as to adjust the transmitting power of the external energy controller.

In the above-mentioned implantable neurostimulator system, the implantable neurostimulator 1 further comprises a post-measurement feedback circuit, the post-measurement feedback circuit is used for measuring the real-time stimulation parameters on the stimulation electrode and transmitting the real-time stimulation parameters to the main control CPU, the main control CPU stores the real-time stimulation parameters in the main control memory and sends the real-time stimulation parameters to the external energy controller at regular time, or responds to a data reading instruction and sends the real-time stimulation parameters to the external energy controller; the external energy controller includes a memory unit to store real-time stimulation parameters received from the implantable neural stimulator.

In the above-mentioned implantable neurostimulator system, the external energy controller 2 further comprises an input device, a display device and a power supply; the input device and the display device are used for realizing human-computer interaction so as to send the control information to the implantable neural stimulator; the control information includes instructions for temporarily modifying the clinical stimulation parameters, and after the system is restarted, the temporarily modified clinical stimulation parameters are restored to the original set values.

In the above implantable neurostimulator system, the control information further comprises an upshift or downshift instruction so as to adjust the stimulation intensity of the stimulation pulse sequence as needed.

In the above-mentioned implantable neurostimulator system, the control information further comprises the data reading instruction, so as to read the operation data including the real-time stimulation parameters from the implantable neurostimulator at any time.

Figure 2 illustrates a functional block diagram of another embodiment of an implantable neurostimulator system incorporating the present invention. Compared to the embodiment in fig. 1, the embodiment in fig. 2 is added with an upper computer 3. The upper computer is not necessary. The addition of the upper computer is beneficial to improving the human-computer interaction function, so that doctors or patients can operate the nerve stimulation system more conveniently, and more complex functions can be set for the nerve stimulation system conveniently.

In the implantable neurostimulator system shown in fig. 2, an upper computer serving as a control and information processing platform is added, the external energy controller further comprises an upper computer communication module, and the upper computer is communicated with the external energy controller through the upper computer communication module, so that instructions are sent to the external energy controller and the implantable neurostimulator through the external energy controller, or data are read from the external energy controller.

The upper computer communication module can be a wireless communication module, such as a Bluetooth communication module, so that communication connection is more convenient. The upper computer can also be provided with a data analysis management system for analyzing and managing the data read from the external energy controller, thereby being beneficial to appointing and modifying the clinical stimulation parameter combination.

[ implantable neural stimulator ]

Fig. 3 shows a functional block diagram of an implantable neural stimulator of the present invention.

As shown in fig. 3, the implantable neurostimulator 1 of the present invention, which communicates with the external energy controller and receives electric energy by radio frequency, comprises: a main control chip 11 including a main control CPU 111, a main control memory 112, and a digital-to-analog conversion current source circuit (i-DAC) 113; a stimulator antenna and its impedance matching circuit 12, which is radio frequency coupled to the external energy controller, to receive input signals containing electrical energy and control information from the external energy controller, and to be able to send data to the external energy controller; a rectifying tank circuit 13 connected to the impedance matching circuit 12 and the main control chip 11, respectively, so as to extract and store electric energy from the received input signal and supply power to the main control chip 11; a modulation/demodulation circuit 14 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 transmit the control information to the main control chip 11, and transmit the data transmitted by the main control chip 11 to the impedance matching circuit after modulating the data, and transmit the data to an external energy controller through a stimulator antenna; an electrode interface 15 connected to the main control chip 11, receiving polarity distribution information from the main control chip 11, and receiving a stimulation pulse sequence from the digital-to-analog conversion current source circuit 113; one or more stimulation electrodes 16 connected to the electrode interface 15, which distributes the stimulation pulse sequences to the respective corresponding stimulation electrodes 16 according to polarity distribution information; the main control memory 112 stores a control program and stores the received control information, the main control CPU runs the control program to control the digital-to-analog conversion current source circuit 113 to generate the stimulation pulse sequence according to the control information, the control information includes a combination of clinical stimulation parameters, and the combination of the clinical stimulation parameters includes a polarity distribution information parameter, a pulse width parameter, a pulse amplitude parameter, and a pulse frequency parameter.

The master memory 112 is preferably a non-volatile memory to store data even after power is removed. In this way, the implantable neurostimulator 1 can be adapted to the entire treatment phase by simply configuring it for each patient according to the treatment protocol before each treatment phase begins. Thus, the need for frequent setup of the implantable neurostimulator 1 by the physician is avoided.

The clinical stimulation parameter combinations may include a plurality of groups, each group of clinical stimulation parameter combinations has a respective code, and the control information further includes a clinical stimulation parameter code, which corresponds to the codes of the plurality of groups of clinical stimulation parameter combinations stored in the main control memory one to one. In this way, the user (doctor or patient) can operate the external energy controller to directly invoke the corresponding treatment protocol (corresponding to the corresponding clinical stimulation parameter combination) according to the progress of the treatment. The trouble that the implantable nerve stimulator needs to be frequently configured along with the improvement of the disease condition of the patient is avoided.

The 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 step-by-step manner in response to the up-down shift control instruction. Thus, the patient can adjust the intensity of stimulation at any time according to the experience of the patient. In the implantable neurostimulator 1, the control information also comprises a data reading instruction, and the main control CPU responds to the data reading instruction and sends corresponding data stored in the main control memory to the external energy controller 2. Thus, the patient or physician may obtain various combinations of treatment parameters stored in implantable neurostimulator 1, as well as data generated by the operation of implantable neurostimulator 1.

Implantable neurostimulators employ a sequence of stimulation pulses to treat a patient. When the pulse frequency is high, the charge between adjacent stimulation pulses cannot be sufficiently released, thereby making the actual pulse waveform sequence different from the pulse waveform sequence required for treatment. This will affect the therapeutic effect and also reduce the lifetime of the implantable neurostimulator itself.

In implantable neurostimulator 1, the parameters of the combination of clinical stimulation parameters further include a charge balance time of sufficient length to ensure that the charge between adjacent electrical stimulation pulses is sufficiently released to achieve passive charge balance. Therefore, the problem that the charges between adjacent electric stimulation pulses cannot be released in the existing nerve stimulator is solved.

As shown in fig. 3, in the implantable neurostimulator 1, a charge balancing circuit 17 is further 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 balancing circuit 17 can apply reverse pulses to the electrode interface 15 between adjacent electrical stimulation pulses, so as to realize active charge balancing. Active charge balancing can complete the discharge process faster than passive charge balancing, which is naturally discharged. Clearly, this active charge balancing allows higher stimulation pulse frequencies to be employed. Conversely, charge balancing circuit 17 is not necessary, depending on the frequency of the stimulation pulses employed by implantable neurostimulator 1.

As shown in fig. 3, the implantable neurostimulator 1 further comprises an operation data memory 18 for storing various operation data generated during the operation of the implantable neurostimulator. The control information received from the external energy controller further includes a data reading instruction, and the main control CPU 111 transmits the data stored in the operation data memory 18 to the external energy controller 2 in response to the data reading instruction.

It should be noted that the operation data memory 18 is not necessary, and various operation data generated during the operation of the implantable neurostimulator can be stored in a certain partition of the main memory 112 as long as the storage capacity of the main memory is large enough. The operating data memory 18 is preferably a non-volatile memory to store data even after power is removed. In this way, the external energy controller can retrieve the operation data of the implanted nerve stimulator as required within a period of time within the allowable range of the storage space. Data loss due to sudden communication interruption is also prevented.

As shown in fig. 3, the implantable neurostimulator 1 further comprises a post-measurement feedback circuit 19, wherein 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 electrode 16 and transmit the real-time stimulation parameters to the main control chip 11, and the main control chip stores the real-time stimulation parameters in the operation data storage 18.

The main control chip 11 can compare the real-time stimulation parameters with the stored clinical stimulation parameters, and modify the stimulation signals applied to the stimulation electrodes according to the comparison result.

It should be noted that a post-measurement feedback circuit is not necessary. As a simplified configuration, the implantable neurostimulator may be designed to operate in a simple and reliable manner without the need to measure the operating parameters of the stimulation electrodes. This helps to reduce costs.

In the implantable neurostimulator 1 shown in fig. 3, the implantable neurostimulator further comprises a pre-measurement feedback circuit 10, the pre-measurement feedback circuit 10 is arranged between the rectification energy storage circuit 13 and the main control chip 11, so as to measure the real-time electric energy storage amount in the rectification energy storage circuit 13 at any time and transmit the real-time electric energy storage amount to the main control chip 11, and the main control chip stores the real-time electric energy storage amount in the operation data storage 18.

The main control chip 11 evaluates whether the radio frequency input electric energy needs to be adjusted according to the real-time electric energy storage amount, and when the real-time electric energy storage amount is lower than a set value, the main control chip 11 sends a power adjustment instruction to the external energy controller 2 antenna through the stimulator antenna and the impedance matching circuit 12 thereof, so as to adjust the transmitting power of the external energy controller 2.

As described above, the implantable neurostimulator 1 of the present invention has a master memory and an operation data memory. As a data management measure, the main control chip 11 may actively transmit data to the external energy controller, that is, periodically transmit various data stored in the main control memory and/or the operation data memory to the external energy controller.

In the schematic block diagram of the implantable neurostimulator shown in fig. 3, the main control chip 11 only comprises 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 parts serve as peripheral circuits. Of course, in consideration of balancing the improvement of integration, the reduction of volume, and the process cost, some or all of the pre-measurement feedback circuit, the modulation/demodulation circuit, the electrode interface, the charge balance circuit, the operation data memory, and the post-measurement feedback circuit may be designed in the main control chip 11. For example, in the schematic block diagram of another implantable neurostimulator shown in fig. 4, the main control chip 11 comprises a main control CPU 111, a main control memory 112, a digital-to-analog conversion current source circuit (i-DAC)113, a pre-measurement feedback circuit 110, a modulation/demodulation circuit 114, an electrode interface 115, a charge balance circuit 117, a running data memory 118 and a post-measurement feedback circuit 119.

In summary, the implantable neurostimulator 1 of the present invention is configured with parameters by the external energy controller, and starts to operate by the external energy controller. Once activated, the implantable neurostimulator 1 begins to operate actively, depending on the configured parameters, to complete the electrode pulse stimulation therapy for the patient.

[ in vitro energy control device ]

As shown in fig. 1 and 2, the external energy controller 2 of the neurostimulation system of the present invention transmits electric energy to the implantable neurostimulator 1 by radio frequency and communicates with the implantable neurostimulator 1. As shown in fig. 5, the in vitro energy controller 2 of the neurostimulation system of the present invention comprises: an input device 20, the external energy controller 2 receives information through the input device 20; the antenna module 21 is in radio frequency coupling with a stimulator antenna of the implantable neural stimulator 1, so that an input signal containing electric energy and control information is sent to the implantable neural stimulator 1, and instructions and data can be received from the implantable neural stimulator 1; a display device 22, wherein the display 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 neural stimulator 1; a storage unit 23 that stores an operation program of the external energy controller 2, information input from the input device 20, and data received from the implantable neurostimulator 1; a power supply 24 for supplying power to the external energy controller of the whole nerve stimulation system; and a control unit 25 controlling the connection of the input device 20, the antenna module 21, the power supply 24, and the display device 22, respectively, thereby controlling the operation of the entire external energy controller 2.

The user may operate the input device. The information input from input device 20 may include information to configure external controller 2, information to configure implantable neurostimulator 1, and instructions to read data into implantable neurostimulator 1. In addition, by operating input device 20, any information of in vitro controller 2 itself, including information stored in memory unit 23 (e.g., operational data from implantable neurostimulator 1) may also be displayed.

The input device 20 may be any device suitable for inputting information, such as a key, a hand-written screen, a voice input microphone, etc. Preferably, the input device 20 has a stimulation intensity adjustment unit, which can adjust the stimulation intensity of the implantable neurostimulator 1 in an up-down manner. The stimulation intensity adjusting unit can be an up-down shifting key or a screen display virtual key.

The display device 22 may be any device capable of displaying information, such as a liquid crystal display, an LED display, or the like.

The storage unit 23 is preferably a nonvolatile memory so as to store data even after power is turned off. In this way, the external energy controller 2 of the neurostimulation system only needs to be configured for each patient according to the treatment scheme before each treatment phase begins, and the method can be applied to the whole treatment phase. Thus, the need for frequent set-up of the external energy controller 2 of the neurostimulation system by the physician is avoided.

The power source 24 may be a conventional battery or a rechargeable battery.

The instruction received from the implantable neurostimulator 1 is an instruction for adjusting the transmitting power of the external energy controller, and the control unit 25 adjusts the transmitting power of the antenna module 21 according to the instruction so as to meet the operation requirement of the implantable neurostimulator 1. This way of adjusting the transmit power according to the operational requirements of the implantable neurostimulator 1 is clearly more helpful to ensure reliable operation of the implantable neurostimulator 1.

The external energy controller 2 of the nerve stimulation system can also be provided with an upper computer communication module 26 for receiving instructions from the upper computer 3 and sending data to the upper computer 3, wherein the instructions configure the external energy controller 2 for the incoming nerve stimulation system or configure the implantable nerve stimulator 2; or used for transmitting various data of the external energy controller 2 of the nerve stimulation system and data from the implanted nerve stimulator 1 to the upper computer 3.

The upper computer 3 can be provided with special upper computer software, and a user can send an instruction to the external energy controller 2 of the nerve stimulation system through the upper computer software, so as to operate the external energy controller 2 of the nerve stimulation system, or operate the implantable nerve stimulator 1 through the external energy controller 2 of the nerve stimulation system, wherein the operation comprises setting, measuring, programming and data management of clinical stimulation parameters.

The upper computer software can also operate the upper computer 3 to connect with a network or an internal server to perform backup and update of programs and data.

Obviously, the upper computer 3 and the software containing the upper computer can improve the convenience of operation and is beneficial to setting a more complex treatment scheme.

The upper computer communication module 26 of the external energy controller 2 of the nerve stimulation system of the present invention may be a wireless communication module, so as to exchange commands and data with the upper computer 3 in a wireless communication manner. Obviously, the wireless communication mode can make the connection between the host computer 3 of the external energy controller 2 of the nerve stimulation system more convenient to improve the convenience of operation and the simplicity of product design.

The wireless communication module can be a Bluetooth module.

The external energy control device 2 of the neurostimulation system of the present invention is often designed to be worn on-person so as to be able to move anywhere with the patient. This wearable design requires a reduction in the size of the product and therefore the battery size, which requires significant consideration for the energy saving design of the device. The Bluetooth communication has the characteristic of low power consumption, and can well meet the energy-saving requirement.

The implantable neurostimulator 1 is required to have high safety as an in vivo therapeutic device. That is, an illegal operator or an illegal external control device is to be prevented from interfering with the implantable neurostimulator 1. Bluetooth also provides two-layer password protection, can prevent this illegal invasion risk more effectively.

Optionally, the wireless communication module may also be a WIFI module. Depending on the treatment regimen, certain treatment regimens may yield a large amount of data. This increases the amount of data that needs to be transmitted. The WIFI communication has high transmission speed, and the requirement is favorably met.

[ technical advantages ]

In the implantable neural stimulator system, the implantable neural stimulator 1 is provided with the rectifying and energy-storing circuit 13, so that the electric energy stored by the rectifying and energy-storing circuit 13 is supplied to the whole implantable neural stimulator 1 to operate. Meanwhile, the rectifying 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 implanted nerve stimulator 1. The storage of electrical energy in the rectified tank circuit 13 can be monitored by a pre-measurement circuit. When the electric energy storage capacity is reduced, the implanted nerve stimulator 1 sends an instruction to the external energy controller 2, and the external energy controller 2 increases the transmitting power. Therefore, the implanted nerve stimulator 1 can be stably supplied with power.

In the implantable neurostimulator system, because the electrical pulse stimulation is implemented based on the treatment parameter combination stored in the main control memory of the implantable neurostimulator 1, only the radio-frequency electrical energy needs to be provided by the external energy controller, and the real-time stimulation signal containing the stimulation electrical pulse does not need to be obtained from the external energy controller. Therefore, even if the communication is interrupted or is not smooth due to an emergency, the treatment failure can not be caused.

In the implantable neural stimulator system, because the implantable neural stimulator is provided with the energy storage circuit, even if radio frequency power supply is interrupted for a short time due to communication interruption or communication unsmooth caused by an emergency, the implantable neural stimulator can continue to operate for a period of time until the communication is recovered to be normal, so that treatment is not interrupted.

In the system of the implanted nerve stimulator, the memory of the implanted nerve stimulator can store various operation parameters and can send the data to the external energy controller during the treatment intermittence period or when the communication is not busy, so the implanted nerve stimulator can further ensure the smooth communication when the communication is needed, thereby improving the performance of the equipment. For example, when a doctor or a patient operates the in-vitro energy controller to send a command to the implanted neural stimulator, the implanted neural stimulator does not send data to the outside to ensure smooth communication.

The foregoing descriptions of specific exemplary embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The exemplary embodiments were chosen and described in order to explain certain principles of the invention and its practical application to enable others skilled in the art to make and use various exemplary embodiments of the invention and various alternatives and modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the following claims and their equivalents.

Claims

1. An implantable neurostimulator system comprises an implantable neurostimulator and an external energy controller, wherein the implantable neurostimulator is communicated with the external energy controller in a radio frequency mode and receives electric energy, the implantable neurostimulator is provided with a main control CPU, a main control memory and a stimulation electrode, the main control memory is used for storing control information containing clinical stimulation parameters, and the main control CPU actively generates stimulation pulse sequences by utilizing the clinical stimulation parameters and applies the stimulation pulse sequences to the stimulation electrode.

2. The implantable neurostimulator system of claim 1, wherein the implantable neurostimulator further comprises a rectifying energy storage circuit and a pre-measurement feedback circuit, the rectifying energy storage circuit is used for storing the received electric energy, the pre-measurement feedback circuit is used for measuring the electric energy storage amount in the rectifying energy storage circuit, and when the electric energy storage amount is insufficient, the main control CPU sends a power adjustment command to an external energy controller so as to adjust the transmitting power of the external energy controller.

3. The implantable neurostimulator system of claim 1, wherein the implantable neurostimulator further comprises a post-measurement feedback circuit, the post-measurement feedback circuit is used for measuring the real-time stimulation parameters on the stimulation electrode and transmitting the real-time stimulation parameters to the master CPU, and the master CPU stores the real-time stimulation parameters in the master memory and sends the real-time stimulation parameters to an external energy controller at regular time or sends the real-time stimulation parameters to the external energy controller in response to a data reading instruction; the external energy controller includes a memory unit to store real-time stimulation parameters received from the implantable neural stimulator.

4. The implantable neurostimulator system of claim 3, wherein the external energy controller further comprises an input device, a display device, and a power source; the input device and the display device are used for realizing human-computer interaction so as to send the control information to the implantable neural stimulator; the control information includes instructions to modify a clinical stimulation parameter.

5. The implantable neurostimulator system of claim 4, wherein the control information further comprises an upshift or downshift instruction to adjust the stimulation intensity of the stimulation pulse sequence as needed.

6. An implantable neurostimulator system as claimed in claim 4 or 5, wherein the control information further comprises the data reading instructions to read operational data including real-time stimulation parameters from the implantable neurostimulator at any time.

7. The implantable neurostimulator system of claim 3, further comprising an upper computer as a control and information processing platform, the external energy controller further comprising an upper computer communication module, the upper computer communicating with the external energy controller through the upper computer communication module to send commands to the external energy controller and through the external energy controller to the implantable neurostimulator, or to read data from the external energy controller.

8. An implantable neurostimulator system as claimed in claim 7 wherein the upper computer communication module is a wireless communication module such as Bluetooth.

9. An implantable neurostimulator system as claimed in claim 7 wherein the host computer has a data analysis management system for analyzing and managing data read from the external energy controller to facilitate the specification and modification of clinical stimulation parameter combinations.