Implantable neurostimulator, external programmer, and implantable neurostimulator system

Abstract

The present application relates to an implantable nerve stimulator, an external programmer and an implantable nerve stimulator system. The implantable nerve stimulator comprises an antenna, a stimulation parameter register, a CRC register and a processor. The processor generates a stimulation voltage by using received energy, and generates a stimulation pulse sequence by using stimulation parameters stored in the stimulation parameter register; when antenna position offset is determined according to the stimulation voltage during stimulation, the stimulation is paused, and a state of the stimulation pause is sent to the external programmer; when it is determined that the external programmer reads the CRC code stored in the CRC register, the CRC code of the stimulation parameters stored in the stimulation parameter register is calculated by using the CRC register, and the calculated CRC code is sent to the external programmer to determine whether the antenna position offset causes the stimulation parameters stored in the stimulation parameter register to change. The present application can cope with the decrease of the stimulation voltage and the mutation of the stimulation parameters caused by the antenna offset.

Description

Technical Field

[0001] This invention relates to the field of nerve stimulation technology, specifically to implantable nerve stimulators, external programmers, and implantable nerve stimulator systems. Background Technology

[0002] Implantable neurostimulator systems, which include external programmers and implantable neurostimulators, are already widely used in the medical field. Figure 1 This is a block diagram of an implantable neurostimulator system in the prior art. For example... Figure 1 As shown, the implantable neurostimulator 10 includes an antenna 11, a processor 12, a stimulation parameter register 13, and multiple electrodes 14. The external programmer 20 includes a communication unit 21, a processing unit 22, and a storage unit 23. The communication unit 21 of the external programmer 20 is radio frequency coupled to the antenna 11 of the implantable neurostimulator 10, allowing the external programmer 20 to send input signals containing energy and stimulation parameters (e.g., stimulation frequency and stimulation amplitude) to the implantable neurostimulator 10 and to receive data (e.g., the operating state of the implantable neurostimulator 10) from the implantable neurostimulator 10. The processor 12 of the implantable neurostimulator 10 can generate a stimulation voltage using the energy received via the antenna 11. The stimulation parameter register 13 can store the stimulation parameters received via the antenna 11, and the processor 12 uses the stimulation parameters stored in the stimulation parameter register 13 to generate a stimulation pulse sequence and apply the stimulation pulse sequence to the electrodes 14. The electrodes 14 perform stimulation to achieve treatment of the affected site.

[0003] However, during stimulation, the position of the antenna 11 may shift due to actions such as the patient turning over or bending over, resulting in a decrease in the voltage supplied to the implantable neurostimulator 10 and the stimulation voltage generated by the processor 12. Furthermore, stimulation activities consume energy, accelerating the decrease in stimulation voltage. This can lead to abrupt changes in the values ​​of stimulation parameters in the stimulation parameter register 13, causing abnormal stimulation behavior (such as asymmetry between positive and negative stimulation, charge imbalance, etc.), which can easily lead to nerve damage.

[0004] To avoid these potentially harmful stimulation behaviors, in the first prior art, after the processor 12 detects an abnormal stimulation voltage, the implantable neurostimulator 10 automatically resets, resulting in the loss of stimulation parameters stored in the stimulation parameter register 13 and a pause in stimulation. After the external programmer 20 receives the paused stimulation status from the implantable neurostimulator 10, it restarts the initialization process of the implantable neurostimulator 10. That is, the external programmer 20 adjusts the radio frequency energy supply and sends the previous stimulation parameters and the instruction to continue stimulation back to the implantable neurostimulator 10. However, while this method avoids potential harm to the patient from abnormal stimulation, it complicates the processing flow of the external programmer 20, and the reinitialization of the implantable neurostimulator 10 is time-consuming and energy-intensive.

[0005] In the second prior art, to avoid the repetitive action of reconfiguring stimulation parameters after the implantable neurostimulator 10 is reset, a rewritable non-volatile memory (such as EEPROM, NAND Flash, etc.) can be additionally provided. In this case, even if the implantable neurostimulator 10 is automatically reset, the stimulation parameters stored in the non-volatile memory will not be lost. If the stimulation parameters do not need to be corrected, the repetitive action of reconfiguring the stimulation parameters is avoided, and stimulation interruptions caused by antenna misalignment can be quickly adjusted, allowing stimulation to resume without affecting the patient's experience. However, while the method of embedding EEPROM in the implantable neurostimulator 10 avoids the reconfiguration of stimulation parameters when the implantable neurostimulator 10 is restarted, EEPROM increases the area and power consumption of the implantable neurostimulator 10 compared to traditional RAM or registers. In addition, EEPROM itself has a limited number of erase / write cycles, which limits the changes to the patient's stimulation parameters. In terms of manufacturing processes, due to the special structures of EEPROM, such as floating-gate transistors, more precise processes are required to control the characteristics of the transistors and the performance of the memory cells. These include factors such as the thickness of the oxide layer of the floating gate and the amount of injected charge. These precise process requirements make the manufacturing process of EEPROM more complex. While NAND Flash is also a non-volatile memory, its characteristics are suitable for large-capacity, sequential access, and cost-sensitive data storage, but not for scenarios like implantable neurostimulators 10, which only store key stimulation parameters.

[0006] The above description of the background technology is only for the purpose of facilitating a deeper understanding of the technical solution of the present invention (the technical means used, the technical problems solved, and the technical effects produced, etc.), and should not be regarded as an admission or in any form an implication that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0007] The purpose of this invention is to provide an implantable neurostimulator, an external programmer, and an implantable neurostimulator system that can cope with the reduction in stimulation voltage caused by antenna offset of the implantable neurostimulator and the sudden change in the value of stimulation parameters in the stimulation parameter register.

[0008] According to one embodiment of the present invention, an implantable neurostimulator is provided, comprising: an antenna configured to: communicate with and receive energy from an external programmer via radio frequency coupling to a communication unit of an external programmer; a stimulation parameter register configured to: store stimulation parameters received from the external programmer via the antenna; and a cyclic redundancy check (CR) register. The processor is configured to: store intermediate values ​​during CRC code calculation and the CRC code as the calculation result; generate a stimulation voltage using energy received via the antenna and generate a stimulation pulse sequence using stimulation parameters stored in the stimulation parameter register; pause stimulation when an antenna position offset is determined based on a comparison between the stimulation voltage and a set reference voltage during stimulation; send the paused stimulation status to the external programmer via the antenna when the external programmer's access to the implanted neurostimulator is determined based on an access signal received via the antenna; calculate the CRC code of the stimulation parameters stored in the stimulation parameter register using the CRC register; and send the calculated CRC code to the external programmer via the antenna so that the external programmer can determine whether the antenna position offset has caused a change in the stimulation parameters stored in the stimulation parameter register.

[0009] The processor can be configured to: monitor the stimulation voltage in real time during the process of determining whether the antenna position is offset, compare the monitored stimulation voltage with a reference voltage, determine that the antenna position is offset when the monitored stimulation voltage is less than the reference voltage, and determine that the antenna position is not offset when the monitored stimulation voltage is greater than or equal to the reference voltage; the reference voltage is set by the external programmer according to the stimulation parameters to be sent to the implantable neurostimulator, and the processor receives the reference voltage from the external programmer via the antenna.

[0010] The processor can be further configured to generate a higher stimulation voltage using the energy amplified by the external programmer received via the antenna after sending the state of stimulation pause to the external programmer.

[0011] The processor can be further configured to: after sending the calculated CRC code to the external programmer, continue stimulation when a command to continue stimulation is received from the external programmer via the antenna; and change the stimulation parameters stored in the stimulation parameter register to the received stimulation parameters before receiving the command to continue stimulation from the external programmer via the antenna.

[0012] According to another embodiment of the present invention, an external programmer is provided, comprising: a communication unit configured to: communicate with an implantable neurostimulator via radio frequency coupling with an antenna of the implantable neurostimulator and to send energy to the implantable neurostimulator; a storage unit, at least a portion of which is configured to: store intermediate values ​​and CRC codes as calculation results during the CRC code calculation process; and a processing unit configured to: set stimulation parameters to be sent to the implantable neurostimulator; calculate the CRC codes of the stimulation parameters to be sent to the implantable neurostimulator using at least a portion of the storage unit; and periodically access the status of the implantable neurostimulator by sending an access signal to the implantable neurostimulator via the communication unit at reference time intervals. The process involves several steps: When a stimulation pause state is received from the implanted neurostimulator via the communication unit, a read signal is sent to the implanted neurostimulator via the communication unit to read the CRC code stored in the CRC register; when a CRC code is received from the implanted neurostimulator via the communication unit, the received CRC code is compared with the CRC code stored in the storage unit; if the received CRC code matches the CRC code stored in the storage unit, it is determined that the antenna position offset has not caused a change in the stimulation parameters stored in the stimulation parameter register; if the received CRC code does not match the CRC code stored in the storage unit, it is determined that the antenna position offset has caused a change in the stimulation parameters stored in the stimulation parameter register.

[0013] The processing unit can be configured to set a reference voltage according to the stimulation parameters to be sent to the implantable neurostimulator, and send the reference voltage to the implantable neurostimulator via a communication unit.

[0014] The processing unit can be configured to: when receiving a state of stimulation pause from the implantable neurostimulator, increase the energy to be sent to the implantable neurostimulator, and send the increased energy to the implantable neurostimulator via the communication unit.

[0015] The processing unit is configured to: after sending the increased energy to the implantable neurostimulator via the communication unit, send a stimulation voltage feedback command to the implantable neurostimulator via the communication unit; receive the stimulation voltage fed back by the implantable neurostimulator via the communication unit; compare the stimulation voltage fed back by the implantable neurostimulator with a reference voltage; and when it is determined that the stimulation voltage fed back by the implantable neurostimulator is less than the reference voltage, further increase the energy to be sent to the implantable neurostimulator.

[0016] The processing unit can be further configured to: when it is determined that the antenna position offset has not caused a change in the stimulation parameters stored in the stimulation parameter register, send a command to continue stimulation to the implantable neurostimulator via the communication unit; when it is determined that the antenna position offset has caused a change in the stimulation parameters stored in the stimulation parameter register, resend the set stimulation parameters to the implantable neurostimulator via the communication unit, and after sending the set stimulation parameters, send a command to continue stimulation to the implantable neurostimulator via the communication unit again.

[0017] According to another embodiment of the present invention, an implantable neurostimulator system is provided, which includes the above-described implantable neurostimulator and the above-described external programmer.

[0018] The present invention, employing the above technical solution, has the following beneficial effects: The present invention allows the external programmer to set the reference voltage simultaneously with the stimulation parameters, and the external programmer has sufficient processing time. When the detected stimulation voltage is lower than the reference voltage, the implantable neurostimulator can promptly pause stimulation, reducing energy consumption. Furthermore, the external programmer can promptly adjust the radio frequency energy to prevent the stimulation voltage from falling below the normal operating voltage requirement. Under conditions of high energy consumption, a small probability of sudden changes in stimulation parameter values ​​may occur. The external programmer can determine whether the CRC code in the implantable neurostimulator matches the CRC code in the external programmer. When the two CRC codes match, the stimulation parameters do not need to be reconfigured, thus shortening the processing time for voltage anomalies. Attached Figure Description

[0019] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. For clarity, the same components in different drawings are shown with the same reference numerals. It should be noted that the drawings are for illustrative purposes only and are not necessarily drawn to scale. In these drawings:

[0020] Figure 1 This is a block diagram of an implantable neurostimulator system in the prior art.

[0021] Figure 2This is a block diagram of an implantable neurostimulator, an external programmer, and an implantable neurostimulator system including the implantable neurostimulator and the external programmer according to an embodiment of the present invention.

[0022] Figures 3A to 3C This is a schematic diagram of the data flow of an implantable neurostimulator system according to an exemplary embodiment of the present invention. Detailed Implementation

[0023] The following provides a detailed description of the embodiments of the present invention. These embodiments are implemented based on the technical solution of the present invention, and provide detailed implementation methods and specific operation processes. However, the scope of protection of the present invention is not limited to the following embodiments.

[0024] Figure 2 This is a block diagram of an implantable neurostimulator, an external programmer, and an implantable neurostimulator system including the implantable neurostimulator and the external programmer, according to an embodiment of the present invention. Figure 2 As shown, the implantable neurostimulator according to an embodiment of the present invention includes an antenna 11, a processor 12, a stimulation parameter register 13, a cyclic redundancy check (CRC) register 15, and multiple electrodes 14. The external programmer according to an embodiment of the present invention includes a communication unit 21, a processing unit 22, and a storage unit 23.

[0025] Figures 3A to 3C This is a schematic diagram of the data flow of an implantable neurostimulator system according to an exemplary embodiment of the present invention. The following will be combined with... Figure 2 as well as Figures 3A to 3C The configuration of each component of the implantable neurostimulator and external programmer according to an embodiment of the present invention will be described in detail.

[0026] like Figure 3A As shown, from the perspective of the external programmer 20, the communication unit 21 is radio frequency coupled to the antenna 11 of the implantable neurostimulator 10, thereby enabling communication with the implantable neurostimulator 10 and transmitting energy to the implantable neurostimulator 10 (S31). From the perspective of the implantable neurostimulator 10, the antenna 11 is radio frequency coupled to the communication unit 21 of the external programmer 20, thereby enabling communication with the external programmer 20 and receiving energy from the external programmer 20 (S31). The processor 12 uses the energy received via the antenna 11 to generate a stimulation voltage (S32).

[0027] Processing unit 22 can set the stimulation parameters to be sent to implantable neurostimulator 10 (S33). According to an embodiment of the present invention, processing unit 22 uses at least a portion of storage unit 23 to calculate the CRC code of the stimulation parameters to be sent to implantable neurostimulator 10, and at least a portion of storage unit stores intermediate values ​​and the CRC code as the calculation result during the CRC code calculation process (S34). The calculation of the CRC code requires data bit operations to be performed through registers, including shifting, XOR operations, etc. Specifically, the CRC16 CCIT / AUG algorithm can be used. For example, in sixteen-bit data processing, the register stores the data to be calculated and the generator polynomial, and generates the check code through shifting and XOR operations. Therefore, at least a portion of storage unit 23 can be used as a CRC code register.

[0028] Typically, stimulus parameters may include the duration of positive stimulation, the duration of negative stimulation, the time interval between positive and negative stimuli, and the stimulus amplitude. According to embodiments of the present invention, stimulus parameters comprising multiple values ​​are converted into a single 16-bit value, which helps reduce communication costs.

[0029] Processing unit 22 can send preset stimulation parameters to implantable neurostimulator 10 via communication unit 21 (S35). Processor 12 receives stimulation parameters from external programmer 20 via antenna (S36). Processor 12 stores the stimulation parameters received from external programmer 20 via antenna 11 in stimulation parameter register 13 (S37). When processor 12 generates stimulation voltage, processor 12 can generate stimulation pulse sequence using the stimulation parameters stored in stimulation parameter register 13 (S38) and apply stimulation pulse sequence to electrode 14 (S39). Therefore, electrode 14 can perform stimulation (S40).

[0030] like Figure 3B As shown, during stimulation performed by the implanted neurostimulator 10 (i.e., electrode 14), the processor 12 determines whether the antenna position has shifted based on a comparison between the stimulation voltage and a set reference voltage. Specifically, the processor 12 can monitor the stimulation voltage in real time (S41) and compare the monitored stimulation voltage with the reference voltage to determine whether the monitored stimulation voltage is less than the reference voltage (S42).

[0031] When it is determined that the stimulation voltage is greater than or equal to the reference voltage (S42 "No"), the processor 12 determines that the antenna position has not shifted.

[0032] When it is determined that the stimulation voltage is less than the reference voltage (S42 "Yes"), the processor 12 determines that the antenna position is offset. Furthermore, when the antenna position is offset, the processor 12 pauses the stimulation (S43).

[0033] The external programmer 20 can periodically access the state of the implantable neurostimulator 10 by sending an access signal to the implantable neurostimulator 10 via the communication unit 21 at reference intervals. Therefore, when the external programmer 20 once again accesses the state of the implantable neurostimulator 10 by sending an access signal to the implantable neurostimulator 10 via the communication unit 21 (S61), the implantable neurostimulator 10 determines the state of the external programmer 20 accessing the implantable neurostimulator 10 based on the access signal received from the external programmer 20 via the antenna 11 (S62), and sends the state of stimulating pause to the external programmer 20 via the antenna 11 (S44).

[0034] In an exemplary embodiment, the reference voltage is set by the external programmer 20 according to the stimulation parameters to be sent to the implantable neurostimulator 10, and in step S36, the processor 12 receives the reference voltage from the external programmer 20 in addition to the stimulation parameters via the antenna 11. That is, in step S33, the processing unit 22 sets the reference voltage according to the stimulation parameters to be sent to the implantable neurostimulator 10, and in step S35, the stimulation parameters and the reference voltage are sent together to the implantable neurostimulator 10 via the communication unit 21.

[0035] After step S44, when the processing unit 22 receives a stimulation pause state from the implantable neurostimulator 10 via the communication unit 21 (S45), the processing unit 22 adjusts (specifically, increases) the energy to be sent to the implantable neurostimulator 10 and sends the increased energy to the implantable neurostimulator 10 via the communication unit 21. Accordingly, the processor 12 can use the increased energy received via the antenna 11 to generate a higher stimulation voltage (S46). Therefore, the problem of reduced stimulation voltage caused by antenna 11 position offset is solved.

[0036] In a preferred embodiment, after sending the increased energy to the implantable neurostimulator 10 via the communication unit 21, the processing unit 22 can send a stimulation voltage feedback command to the implantable neurostimulator 10 via the communication unit 21. Accordingly, after receiving the stimulation voltage feedback command via the antenna 11, the processor 12 included in the implantable neurostimulator 10 feeds back the stimulation voltage to the external programmer 20 via the antenna 11. The processing unit 22 included in the external programmer 20 receives the stimulation voltage fed back by the implantable neurostimulator 10 from the implantable neurostimulator 10 via the communication unit 21 and compares the stimulation voltage fed back by the implantable neurostimulator 10 with a reference voltage. When the processing unit 22 determines that the stimulation voltage fed back by the implantable neurostimulator 10 is still less than the reference voltage, it indicates that the energy increased by the external programmer 20 is insufficient, and therefore the energy to be sent to the implantable neurostimulator 10 can be further increased. In this case, the external programmer 20 can increase the energy to be sent to the implantable neurostimulator 10 in stages.

[0037] Since the displacement of antenna 11 not only leads to a decrease in stimulation voltage but may also cause abrupt changes in the stimulation parameters in stimulation parameter register 13, it is necessary to determine whether the stimulation parameters in stimulation parameter register 13 have changed. If it is determined that the stimulation parameters in stimulation parameter register 13 have changed, it is necessary to correct the stimulation parameters to avoid nerve damage caused by abnormal stimulation behavior.

[0038] Therefore, such as Figure 3C As shown, when the processing unit 22 receives the state of stimulation pause from the implantable neurostimulator 10 via the communication unit 21 (S45), the processing unit 22 reads the CRC code stored in the CRC register 15 by sending a read signal to the implantable neurostimulator 10 via the communication unit 21 (S48).

[0039] When processor 12 determines, based on the read signal received from external programmer 20 via antenna 11, that the external programmer has read the CRC code stored in CRC register 15 (S49), processor 12 uses CRC register 15 to calculate the CRC code of the stimulation parameter stored in stimulation parameter register 13. The CRC register stores intermediate values ​​during the CRC code calculation process and the CRC code as the calculation result (S50). The method by which processor 12 calculates the CRC code of the stimulation parameter is the same as the method by which processing unit 22 calculates the CRC code in step S35. Therefore, based on the same stimulation parameters, the same CRC code can be calculated. Based on different stimulation parameters, different CRC codes can be calculated.

[0040] The processor 12 sends the calculated CRC code to the external programmer 20 via the antenna 11 (S51) so that the external programmer 20 can determine whether the position offset of the antenna 11 causes a change in the stimulation parameters stored in the stimulation parameter register 13.

[0041] When the processing unit 22 receives the CRC code from the implanted neurostimulator 10 (S52), it compares the received CRC code with the CRC code stored in the storage unit 23 in step S34 to determine whether the received CRC code is consistent with the CRC code stored in the storage unit 23 (S53).

[0042] When the received CRC code matches the CRC code stored in the storage unit 23 (S53 "Yes"), the processing unit 22 can determine that the position offset of the antenna 11 has not caused a change in the stimulation parameters stored in the stimulation parameter register 13. Therefore, when the processing unit 22 determines that the position offset of the antenna 11 has not caused a change in the stimulation parameters, the processing unit 22 sends a command to continue stimulation to the implanted neurostimulator 10 via the communication unit 21 (S57).

[0043] When the processor 12 receives a command to continue stimulation from the external programmer 20 via the antenna 11 (S58), the processor 12 continues the stimulation (S59).

[0044] When the received CRC code is inconsistent with the CRC code stored in the storage unit 23 (S53 "No"), the processing unit 22 determines that the position offset of the antenna 11 has caused a change in the stimulation parameters stored in the stimulation parameter register 13. Therefore, when the processing unit 22 determines that the position offset of the antenna 11 has caused a change in the stimulation parameters in the stimulation parameter register 13, the processing unit 22 resends the stimulation parameters set in step S33 to the implantable neurostimulator 10 via the communication unit 21 (S55), and after sending the set stimulation parameters, it sends a command to continue stimulation to the implantable neurostimulator 10 via the communication unit 21 (S57).

[0045] Before the processor 12 receives the instruction to continue stimulation from the external programmer 20 via the antenna 11 (S58), when the processor 12 receives the stimulation parameters from the external programmer 20 via the antenna 11, the processor 12 changes the stimulation parameters stored in the stimulation parameter register 13 to the received stimulation parameters (S60), that is, corrects the stimulation parameters whose values ​​have changed abruptly due to the positional shift of the antenna 11. Subsequently, after the processor 12 receives the instruction to continue stimulation from the external programmer 20 via the antenna 11 (S58), the processor 12 continues the stimulation (S59), that is, generates a stimulation pulse sequence according to the corrected stimulation parameters and applies the stimulation pulse sequence to the electrode 14.

[0046] According to embodiments of the present invention, the implantable neurostimulator, external programmer, and implantable neurostimulator system allow the external programmer to set a reference voltage simultaneously with the stimulation parameters, and the external programmer has sufficient processing time. When the detected stimulation voltage is lower than the reference voltage, the implantable neurostimulator can promptly pause stimulation to reduce energy consumption, and the external programmer can promptly adjust the radio frequency energy to prevent the stimulation voltage from falling below the normal operating voltage requirement (e.g., 1V). In cases of high energy consumption, a small probability of sudden changes in stimulation parameter values ​​may occur. The external programmer can determine whether the CRC code in the implantable neurostimulator matches the CRC code in the external programmer. When the two CRC codes match, the stimulation parameters do not need to be reconfigured, thus shortening the processing time for voltage anomalies.

[0047] Compared with the prior art, which immediately resets the implanted neurostimulator upon detecting a voltage abnormality and then reconfigures the stimulation parameters, the implanted neurostimulator, external programmer, and implanted neurostimulator system according to the embodiments of the present invention can greatly reduce the workload of the external programmer 20 and shorten the processing time for voltage abnormalities.

[0048] Compared to the second method of adding non-volatile memory within the implantable neurostimulator, the implantable neurostimulator, external programmer, and implantable neurostimulator system according to the embodiments of the present invention only add a small amount of hardware control logic to perform CRC code calculation of stimulation parameters, thus avoiding the increase in the area and power consumption of the implantable neurostimulator and the complexity of the manufacturing process.

[0049] The various embodiments of the present invention are not an exhaustive list of all possible combinations, but are intended to describe representative aspects of the invention, and the contents described in the various embodiments can be applied independently or in two or more combinations.

[0050] The description of the exemplary embodiments presented above is merely illustrative of the technical solutions of the present invention and is not intended to be exhaustive, nor is it intended to limit the invention to the precise forms described. Obviously, those skilled in the art can make many changes and variations based on the above teachings. The exemplary embodiments were chosen and described to explain the specific principles of the invention and its practical applications, thereby enabling others skilled in the art to understand, implement, and utilize the various exemplary embodiments of the invention and their various alternatives and modifications. The scope of protection of the present invention is intended to be defined by the appended claims and their equivalents.

Claims

1. An implantable neurostimulator, comprising: The antenna is configured to communicate with and receive energy from the external programmable device via radio frequency coupling with the communication unit of the external programmable device. The stimulation parameter register is configured to store stimulation parameters received from the external programmer via the antenna. The Cyclic Redundancy Check (CRC) register is configured to store intermediate values ​​during the calculation of the CRC code and the CRC code as the calculation result. The processor is configured as follows: The energy received via the antenna is used to generate a stimulation voltage, and the stimulation parameters stored in the stimulation parameter register are used to generate a stimulation pulse sequence. When the antenna position shift is determined during stimulation based on a comparison between the stimulation voltage and a set reference voltage, the stimulation is paused. When the external programmer determines the state of access to the implanted neurostimulator based on the access signal received from the external programmer via the antenna, the state of stimulation pause is sent to the external programmer via the antenna. When the read signal received from the external programmer via the antenna determines that the external programmer has read the cyclic redundancy check code stored in the cyclic redundancy check register, the cyclic redundancy check code of the stimulation parameter stored in the stimulation parameter register is calculated using the cyclic redundancy check register. The calculated cyclic redundancy check code is sent to the external programmer via the antenna, so that the external programmer can determine whether the antenna position offset causes a change in the stimulation parameters stored in the stimulation parameter register.

2. The implantable neurostimulator according to claim 1, wherein, The processor is configured as follows: In the process of determining whether the antenna position has shifted, the stimulation voltage is monitored in real time and compared with the reference voltage. When it is determined that the monitored stimulation voltage is less than the reference voltage, the antenna position is determined to have shifted. When it is determined that the monitored stimulation voltage is greater than or equal to the reference voltage, the antenna position is determined to have not shifted. The reference voltage is set by the external programmer based on the stimulation parameters to be sent to the implantable neurostimulator, and the processor receives the reference voltage from the external programmer via an antenna.

3. The implantable neurostimulator according to claim 2, wherein, The processor is further configured as follows: After the stimulation pause state is sent to the external programmer, a higher stimulation voltage is generated using the energy amplified by the external programmer received via the antenna.

4. The implantable neurostimulator according to claim 3, wherein, The processor is further configured as follows: After the calculated cyclic redundancy check code is sent to the external programmer, the stimulation continues when a command to continue stimulation is received from the external programmer via the antenna. Before receiving a command to continue stimulation from the external programmer via the antenna, when stimulation parameters are received from the external programmer via the antenna, the stimulation parameters stored in the stimulation parameter register are changed to the received stimulation parameters.

5. An external programmer, comprising: The communication unit is configured to communicate with the implantable neurostimulator and send energy to the implantable neurostimulator via radio frequency coupling with the antenna of the implantable neurostimulator. A storage unit, at least a portion of which is configured to store intermediate values ​​and cyclic redundancy check codes as the calculation result during the calculation process; The processing unit is configured as follows: Set the stimulation parameters to be sent to the implanted neurostimulator; Using at least a portion of the storage unit, a cyclic redundancy check code is calculated for the stimulation parameters to be sent to the implantable neurostimulator. The status of the implantable neurostimulator is periodically accessed by sending access signals to the implantable neurostimulator via the communication unit at reference intervals. When a state of stimulation pause is received from the implantable neurostimulator via the communication unit, the cyclic redundancy check code stored in the cyclic redundancy check register is read by sending a read signal to the implantable neurostimulator via the communication unit. When a cyclic redundancy check code is received from the implanted neurostimulator via the communication unit, the received cyclic redundancy check code is compared with the cyclic redundancy check code stored in the storage unit. When the received cyclic redundancy check code matches the cyclic redundancy check code stored in the storage unit, it is determined that the antenna position offset has not caused the stimulus parameters stored in the stimulus parameter register to change. When the received cyclic redundancy check code is inconsistent with the cyclic redundancy check code stored in the storage unit, it is determined that the antenna position offset has caused a change in the stimulation parameters stored in the stimulation parameter register.

6. The external programmer according to claim 5, wherein, The processing unit is configured as follows: The reference voltage is set according to the stimulation parameters to be sent to the implantable neurostimulator, and the reference voltage is sent to the implantable neurostimulator via the communication unit.

7. The external programming device according to claim 6, wherein, The processing unit is configured as follows: When a state of stimulation pause is received from the implantable neurostimulator, the energy to be sent to the implantable neurostimulator is increased, and the increased energy is sent to the implantable neurostimulator via the communication unit.

8. The external programming device according to claim 7, wherein, The processing unit is configured as follows: After the increased energy is sent to the implantable neurostimulator via the communication unit, a stimulation voltage feedback command is sent to the implantable neurostimulator via the communication unit. The device receives stimulation voltage fed back from the implanted neurostimulator via a communication unit. The stimulation voltage fed back by the implanted neurostimulator is compared with a reference voltage; When it is determined that the stimulation voltage fed back by the implantable neurostimulator is less than the reference voltage, the energy to be sent to the implantable neurostimulator is further increased.

9. The external programming device according to claim 7, wherein, The processing unit is further configured as follows: When it is determined that the antenna position offset has not caused a change in the stimulation parameters stored in the stimulation parameter register, a command to continue stimulation is sent to the implanted neurostimulator via the communication unit. When it is determined that the antenna position offset has caused a change in the stimulation parameters stored in the stimulation parameter register, the set stimulation parameters are resent to the implantable neurostimulator via the communication unit. After sending the set stimulation parameters, the communication unit sends a command to the implantable neurostimulator to continue stimulation.

10. An implantable neurostimulator system comprising an implantable neurostimulator according to any one of claims 1 to 4 and an external programmer according to any one of claims 5 to 9.

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