Implantable nerve stimulator, in-vitro program controller and implantable nerve stimulator system

Abstract

The invention relates to an implantable nerve stimulator, an in-vitro program controller 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 the received energy and generates a stimulation pulse sequence by using stimulation parameters stored in a stimulation parameter register; when it is determined that the position of the antenna deviates according to the stimulation voltage in the stimulation period, stimulation is paused, and the stimulation pause state is sent to the in-vitro program controller; when it is determined that the in-vitro program controller reads the CRC code stored in the CRC register, the CRC register is used for calculating the CRC code of the stimulation parameter stored in the stimulation parameter register, and the calculated CRC code is sent to the in-vitro program controller; and determining whether the position offset of the antenna causes the stimulation parameters stored in the stimulation parameter register to change or not by the in-vitro program controller. According to the invention, stimulation voltage reduction and stimulation parameter mutation caused by antenna offset can be coped with.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of nerve stimulation, and in particular to an implantable nerve stimulator, an external programmer and an implantable nerve stimulator system. BACKGROUND

[0002] An implantable nerve stimulator system including an external programmer and an implantable nerve stimulator has been widely used in the medical field. Figure 1 is a block diagram of an implantable nerve stimulator system in the prior art. As shown in Figure 1 the implantable nerve stimulator 10 includes an antenna 11, a processor 12, a stimulation parameter register 13 and a plurality of electrodes 14. The external programmer 20 includes a communication unit 21, a processing unit 22, a storage unit 23. The communication unit 21 of the external programmer 20 is coupled with the antenna 11 of the implantable nerve stimulator 10 by radio frequency, so that the external programmer 20 can send an input signal containing energy and stimulation parameters (for example, stimulation frequency and stimulation amplitude) to the implantable nerve stimulator 10, and can receive data (for example, the working state of the implantable nerve stimulator 10) from the implantable nerve stimulator 10. The processor 12 of the implantable nerve stimulator 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 generates a stimulation pulse sequence using the stimulation parameters stored in the stimulation parameter register 13 and applies the stimulation pulse sequence to the electrodes 14. The electrodes 14 perform stimulation to achieve treatment of a patient site.

[0003] However, during the stimulation process of the implantable nerve stimulator 10, the position of the antenna 11 may be offset due to the patient's behavior of turning over, bending down, etc., so that the voltage supplied to the implantable nerve stimulator 10 and the stimulation voltage generated by the processor 12 are reduced. In addition, the stimulation behavior consumes energy and accelerates the reduction of the stimulation voltage, which can cause the stimulation parameters in the stimulation parameter register 13 to have a sudden change in value, causing abnormal stimulation behavior (such as positive-negative phase stimulation asymmetry, charge imbalance, etc.), which is easy to cause nerve damage.

[0004] To avoid these harmful stimulation behaviors to the patient, in the first prior art, after the processor 12 detects the abnormal stimulation voltage, the implantable neurostimulator 10 is automatically reset, so that the stimulation parameters stored in the stimulation parameter register 13 are lost and the stimulation is suspended. After the external programmer 20 receives the state of the stimulation suspension from the implantable neurostimulator 10, the initialization program of the implantable neurostimulator 10 is started again, that is, the external programmer 20 adjusts the radio frequency energy supply and sends the previous stimulation parameters and the instruction to continue the stimulation to the implantable neurostimulator 10 again. However, although this way avoids the harm that the abnormal stimulation may cause to the patient, the processing flow of the external programmer 20 becomes complex, and the re-initialization of the implantable neurostimulator 10 also consumes time and energy.

[0005] In the second prior art, in order to avoid the repeated action of reconfiguring the stimulation parameters after the implantable neurostimulator 10 is reset, a multiple-erasable non-volatile storage (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 storage will not be lost. If the stimulation parameters do not need to be corrected, the repeated action of reconfiguring the stimulation parameters is avoided, the stimulation stop caused by the antenna offset can be quickly adjusted, the stimulation is recovered again, and the experience of the patient is not affected. However, the method of embedding EEPROM in the implantable neurostimulator 10 avoids the reconfiguration of the stimulation parameters when the implantable neurostimulator 10 is restarted, but the EEPROM increases the area and power consumption of the implantable neurostimulator 10 compared with the traditional RAM or register, and in addition, the EEPROM itself also has the limitation of the number of erasing times, which limits the change of the stimulation parameters of the patient. In terms of manufacturing process, due to the existence of special structures such as EEPROM floating gate transistor, more precise processes are needed to control the characteristics of the transistor and the performance of the storage unit, such as the thickness of the oxide layer of the floating gate, the amount of injected charge, etc. These precise process requirements make the manufacturing process of the EEPROM more complex. Although NAND Flash is also a non-volatile memory, its characteristics are suitable for large capacity, sequential access, cost-sensitive data storage, and are not suitable for the scenario of the implantable neurostimulator 10 which only saves key stimulation parameters.

[0006] The above statements of the background art are only for the convenience of deep understanding of the technical solutions of the present application (the technical means used, the technical problems solved, and the technical effects generated, etc.), and should not be regarded as acknowledging or in any form implying that the message constitutes the prior art known to those skilled in the art. SUMMARY

[0007] The present application aims to provide an implantable nerve stimulator, an external programming device and an implantable nerve stimulator system, which can cope with the situation that the stimulation voltage is reduced and the stimulation parameter value in the stimulation parameter register is suddenly changed due to the antenna position offset of the implantable nerve stimulator.

[0008] According to one embodiment of the present application, an implantable nerve stimulator is provided, which comprises: an antenna configured to communicate with an external programming device and receive energy from the external programming device through radio frequency coupling with a communication unit of the external programming device; a stimulation parameter register configured to store stimulation parameters received from the external programming device via the antenna; a Cyclic Redundancy Check (CRC) register configured to store intermediate values in the process of calculating a CRC code and the CRC code as a calculation result; a processor configured to generate a stimulation voltage using the energy received via the antenna and generate a stimulation pulse sequence using the stimulation parameters stored in the stimulation parameter register; pause the stimulation when it is determined that the antenna position is offset according to a comparison between the stimulation voltage and a set reference voltage during the stimulation; send the state of pausing the stimulation to the external programming device via the antenna when it is determined that the external programming device accesses the state of the implantable nerve stimulator according to an access signal received from the external programming device via the antenna; calculate the CRC code of the stimulation parameters stored in the stimulation parameter register using the CRC register when it is determined that the external programming device reads the CRC code stored in the CRC register according to a read signal received from the external programming device via the antenna; send the calculated CRC code to the external programming device via the antenna to determine whether the antenna position offset causes the stimulation parameters stored in the stimulation parameter register to change by the external programming device.

[0009] The processor can be configured to monitor the stimulation voltage in real time during the determination of whether the antenna position is offset, compare the monitored stimulation voltage with the reference voltage, determine that the antenna position is offset when it is determined that the monitored stimulation voltage is less than the reference voltage, and determine that the antenna position is not offset when it is determined that the monitored stimulation voltage is greater than or equal to the reference voltage; the reference voltage is set by the external programming device according to the stimulation parameters to be sent to the implantable nerve stimulator, and the processor receives the reference voltage from the external programming device via the antenna.

[0010] The processor can be further configured to generate a higher stimulation voltage using the energy received via the antenna and increased by the external programming device after sending the state of pausing the stimulation to the external programming device.

[0011] The processor can be further configured to, after transmitting the calculated CRC code to the external programmer, continue the stimulation when an instruction to continue the 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 when the stimulation parameters are received from the external programmer via the antenna before the instruction to continue the stimulation is received from the external programmer via the antenna.

[0012] According to another embodiment of the present application, there is provided an external programmer comprising: a communication unit configured to communicate with and transmit energy to an implanted neurostimulator by radio frequency coupling with an antenna of the implanted neurostimulator; a storage unit at least a portion of which is configured to store intermediate values in a process of calculating a CRC code and the CRC code as a result of the calculation; a processing unit configured to set stimulation parameters to be transmitted to the implanted neurostimulator, calculate a CRC code of the stimulation parameters to be transmitted to the implanted neurostimulator using at least a portion of the storage unit, periodically access a state of the implanted neurostimulator by transmitting an access signal to the implanted neurostimulator via the communication unit every reference time interval, read the CRC code stored in the CRC register by transmitting a read signal to the implanted neurostimulator via the communication unit when a state of stimulation pause is received from the implanted neurostimulator via the communication unit, compare the received CRC code with the CRC code stored in the storage unit when the CRC code is received from the implanted neurostimulator via the communication unit, determine that an antenna position shift has not caused the stimulation parameters stored in the stimulation parameter register to change when the received CRC code is identical to the CRC code stored in the storage unit, and determine that the antenna position shift has caused the stimulation parameters stored in the stimulation parameter register to change when the received CRC code is not identical to the CRC code stored in the storage unit.

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

[0014] The processing unit can be configured to increase the energy to be transmitted to the implanted neurostimulator when the state of stimulation pause is received from the implanted neurostimulator, and transmit the increased energy to the implanted 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 instruction to the implantable neurostimulator via the communication unit; receive the stimulation voltage fed back by the implantable neurostimulator from the implantable neurostimulator via the communication unit; compare the stimulation voltage fed back by the implantable neurostimulator with the reference voltage; and further increase the energy to be sent to the implantable neurostimulator when it is determined that the stimulation voltage fed back by the implantable neurostimulator is less than the reference voltage.

[0016] The processing unit can be further configured to: when it is determined that the antenna position offset does not cause the stimulation parameter stored in the stimulation parameter register to change, send an instruction to continue stimulation to the implantable neurostimulator via the communication unit; and when it is determined that the antenna position offset causes the stimulation parameter stored in the stimulation parameter register to change, re-send the set stimulation parameter to the implantable neurostimulator via the communication unit, and after sending the set stimulation parameter, send an instruction to continue stimulation to the implantable neurostimulator via the communication unit again.

[0017] According to still another embodiment of the present application, there is provided an implantable neurostimulator system comprising the implantable neurostimulator described above and the external programmer described above.

[0018] The present application has the following beneficial effects: the present application can set the reference voltage at the same time when setting the stimulation parameter by the external programmer, and the external programmer has sufficient processing time. When the monitored stimulation voltage is less than the reference voltage, the implantable neurostimulator can suspend stimulation in time, reduce energy consumption, and the external programmer can adjust the radio frequency energy in time to prevent the stimulation voltage from being less than the voltage requirement for normal operation. In the case of relatively large energy consumption, there is a small probability of sudden change of the stimulation parameter value, and the external programmer can determine whether the CRC code in the implantable neurostimulator is consistent with the CRC code in the external programmer. When the two CRC codes are consistent, the stimulation parameter does not need to be reconfigured, so as to shorten the processing time of voltage abnormality. BRIEF DESCRIPTION OF DRAWINGS

[0019] Exemplary embodiments of the present application will be described in greater detail below with reference to the accompanying drawings. For the sake of clarity, the same components in the different drawings are denoted by the same reference numerals. It should be noted that the drawings merely show schematic representations of embodiments of the present application and are not necessarily drawn to scale. In these drawings: Figure 1 is a block diagram of an implantable neurostimulator system in the prior art.

[0020] Figure 2is a block diagram of an implantable neurostimulator, an external programmer, and an implanted neurostimulator system including the implantable neurostimulator and the external programmer according to an embodiment of the present application.

[0021] Figures 3A to 3C is a schematic diagram of a data flow of an implanted neurostimulator system according to an exemplary embodiment of the present application. DETAILED DESCRIPTION

[0022] The embodiments of the present application will be described in detail below with the embodiments of the present application being implemented on the premise of the technical solutions of the present application, and detailed implementation manners and specific operation processes are given, but the protection scope of the present application is not limited to the following embodiments.

[0023] Figure 2 is a block diagram of an implantable neurostimulator, an external programmer, and an implanted neurostimulator system including the implantable neurostimulator and the external programmer according to an embodiment of the present application. As shown in Figure 2 , the implantable neurostimulator according to an embodiment of the present application includes an antenna 11, a processor 12, a stimulation parameter register 13, a Cyclic Redundancy Check (CRC) register 15, and a plurality of electrodes 14. The external programmer according to an embodiment of the present application includes a communication unit 21, a processing unit 22, and a storage unit 23.

[0024] Figures 3A to 3C is a schematic diagram of a data flow of an implanted neurostimulator system according to an exemplary embodiment of the present application. Each component of the implantable neurostimulator and the external programmer according to an embodiment of the present application will be described in detail below with reference to Figure 2 and Figures 3A to 3C .

[0025] As shown in Figure 3A , from the perspective of the external programmer 20, the communication unit 21 is coupled to the antenna 11 of the implantable neurostimulator 10 by radio frequency, so as to be able to communicate with the implantable neurostimulator 10 and transmit energy to the implantable neurostimulator 10 (S31). From the perspective of the implantable neurostimulator 10, the antenna 11 is coupled to the communication unit 21 of the external programmer 20 by radio frequency, so as to be able to communicate with the external programmer 20 and receive energy from the external programmer 20 (S31). The processor 12 generates a stimulation voltage by using the energy received via the antenna 11 (S32).

[0026] 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.

[0027] 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.

[0028] 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).

[0029] 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).

[0030] 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.

[0031] 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).

[0032] The external programmer 20 can periodically access the state of the implantable neurostimulator 10 by transmitting an access signal to the implantable neurostimulator 10 via the communication unit 21 every reference interval, and thus, when the external programmer 20 accesses the state of the implantable neurostimulator 10 again by transmitting an access signal to the implantable neurostimulator 10 via the communication unit 21 (S61), the implantable neurostimulator 10 determines that the external programmer 20 accesses the state of the implantable neurostimulator 10 according to the access signal received from the external programmer 20 via the antenna 11 (S62), and transmits the state of the stimulation pause to the external programmer 20 via the antenna 11 (S44).

[0033] In the exemplary embodiment, the reference voltage is set by the external programmer 20 according to the stimulation parameters to be transmitted to the implantable neurostimulator 10, and in step S36, the processor 12 receives the reference voltage from the external programmer 20 via the antenna 11 in addition to the stimulation parameters from the external programmer 20. That is, in step S33, the processing unit 22 sets the reference voltage according to the stimulation parameters to be transmitted to the implantable neurostimulator 10 in addition to setting the stimulation parameters to be transmitted to the implantable neurostimulator 10, and in step S35, transmits the stimulation parameters and the reference voltage to the implantable neurostimulator 10 via the communication unit 21.

[0034] After step S44, when the processing unit 22 receives the state of the stimulation pause from the implantable neurostimulator 10 via the communication unit 21 (S45), the processing unit 22 adjusts (specifically, increases) the energy to be transmitted to the implantable neurostimulator 10, and transmits the increased energy to the implantable neurostimulator 10 via the communication unit 21. Accordingly, the processor 12 can generate a higher stimulation voltage using the increased energy received via the antenna 11 (S46). Thus, the problem of the decrease in the stimulation voltage due to the positional deviation of the antenna 11 is solved.

[0035] 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.

[0036] 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.

[0037] 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).

[0038] 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.

[0039] 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.

[0040] 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).

[0041] 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).

[0042] 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).

[0043] 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).

[0044] 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.

[0045] The implantable neurostimulator, the external programmer and the implanted neurostimulator system according to the embodiments of the present application can set the reference voltage at the same time of setting the stimulation parameters by the external programmer, which has enough processing time. When the monitored stimulation voltage is less than the reference voltage, the implantable neurostimulator can suspend the stimulation in time, reduce the energy consumption, and the external programmer can adjust the RF energy in time to prevent the stimulation voltage from being less than the voltage requirement for normal operation (e.g. 1V). In the case of large energy consumption, there is a small probability of stimulation parameter value mutation. The external programmer can determine whether the CRC code in the implantable neurostimulator is consistent with the CRC code in the external programmer. When the two CRC codes are consistent, the stimulation parameters do not need to be reconfigured, so as to shorten the processing time of voltage abnormality.

[0046] Compared with the prior art of resetting the implantable neurostimulator immediately after detecting the voltage abnormality and then reconfiguring the stimulation parameters, the implantable neurostimulator, the external programmer and the implanted neurostimulator system according to the embodiments of the present application can greatly reduce the workload of the external programmer 20 and shorten the processing time of voltage abnormality.

[0047] Compared with the second method of adding a non-volatile memory in the implantable neurostimulator, the implantable neurostimulator, the external programmer and the implanted neurostimulator system according to the embodiments of the present application only add a small amount of hardware control logic to calculate the CRC code of the stimulation parameters, avoiding the increase of the area and power consumption of the implantable neurostimulator and the complication of the manufacturing process.

[0048] The various embodiments of the present application are not an exhaustive list of all possible combinations, but are intended to describe representative aspects of the present application, and the content described in various embodiments can be applied independently or in combination of two or more.

[0049] The description presented by the above exemplary embodiments is only to illustrate the technical solutions of the present application, and is not intended to be exhaustive, nor to limit the present application to the exact form described. Obviously, many changes and variations are possible for those skilled in the art based on the above teachings. The exemplary embodiments are selected and described to explain the specific principles of the present application and its practical application, so that other skilled in the art can easily understand, implement and utilize the various exemplary embodiments of the present application and various selected forms and modified forms thereof. The scope of protection of the present application 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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