CN116236691A

CN116236691A - Implantable stimulation systems, methods, computer devices, and storage media

Info

Publication number: CN116236691A
Application number: CN202310268313.4A
Authority: CN
Inventors: 夏翔
Original assignee: Shanghai Shanling Medical Technology Co ltd
Current assignee: Shanghai Shanling Medical Technology Co ltd
Priority date: 2023-03-17
Filing date: 2023-03-17
Publication date: 2023-06-09

Abstract

The present application relates to an implantable stimulation system, characterized in that the system comprises: an extracorporeal device and an implantable device coupled; the external equipment is used for outputting a biphase resonance signal according to preset parameters; the implantable device is configured to convert the biphasic resonant signal into a biphasic stimulation signal. The method avoids the problem of charge accumulation, reduces possible tissue damage and stimulation electrode corrosion, prolongs the service life of the stimulation electrode and improves the reliability of long-term use.

Description

Implantable stimulation systems, methods, computer devices, and storage media

Technical Field

The present application relates to the field of medical devices, and in particular, to an implantable stimulation system, method, computer device, and storage medium.

Background

Conventional nerve stimulation devices, such as implantable pulse generators (IPGs for short), employ a wired connection between a stimulation electrode and a stimulation signal source, and the stimulation electrode is implanted in a living body and then wired to generate a stimulation signal via the IPG. Common devices include brain pacemakers (DBS), peripheral nerve stimulators (VNS), and the like. However, this wired technology requires a long wire to be connected, and implantation may require wire insertion through a tunnel, affecting surgical complexity and comfort.

In recent years, wireless nerve stimulation equipment gradually appears, and the wireless nerve stimulation equipment receives signals through magnetic resonance or magnetic induction, and converts the signals into stimulation signals actually required through rectification and filtering. The signal is typically a monophasic signal, lacking a charge output that is in phase opposition to the stimulus signal; or the reverse phase signal and the stimulation signal are not synchronous, so that the problems of tissue damage, electrode surface corrosion, electrode and organism tissue contact impedance change and the like can be caused by charge accumulation and long-term use, and the stimulation effect is influenced.

Disclosure of Invention

In view of the foregoing, it is desirable to provide an implantable stimulation system, method, computer device and storage medium for solving the problem that in the prior art, the stimulation signal is a monophasic signal, resulting in charge accumulation and long-term use affects the stimulation effect.

In a first aspect, the present application provides an implantable stimulation system, the system comprising: an extracorporeal device and an implantable device coupled;

the external equipment is used for outputting a biphase resonance signal according to preset parameters;

the implantable device is configured to convert the biphasic resonant signal into a biphasic stimulation signal.

In one embodiment, the extracorporeal device comprises: the device comprises a power supply module, a control module and a first coupling module;

The power supply module is used for providing working voltage for the control module and the first coupling module;

and the control module is used for outputting a control signal according to the preset parameter and controlling the power supply module to charge or discharge the first resonant coupling module so as to enable the first coupling module to generate a biphase resonant signal.

In one embodiment, the power module includes: an energy storage unit and a power manager;

the energy storage unit is used for storing electric energy;

the power manager is configured to convert the stored electrical energy into an operating voltage suitable for the control module and the first coupling module.

In one embodiment, the control module includes: a processor, a drive unit and a switch assembly;

the processor is used for outputting a corresponding control signal according to the preset parameter;

the driving unit is used for amplifying the intensity of the control signal;

and the switch assembly is used for controlling the power supply module to charge or discharge the first resonant coupling module according to the driven control signal.

In one embodiment, the control module employs an H-bridge circuit.

In one embodiment, the first coupling module includes two first coupling units, each of the first coupling units includes a first capacitor assembly and a first coil assembly, and the first capacitor assembly and the first coil assembly interact to form a first resonant tank;

each of the first coupling units alternately operates to couple a dual-phase resonant signal to the implantable device through the first resonant tank.

In one embodiment, the first coil assembly comprises a plurality of coils, adjacent two of which are partially overlapping.

In one embodiment, the implantable device comprises: the second coupling module and the signal demodulation output module;

the second coupling module is used for receiving the biphase resonance signal;

the signal demodulation output module is used for converting the biphase resonance signal into a biphase stimulation signal.

In one embodiment, the second coupling module includes a second coil and a second capacitive component, the second coil and the second capacitive component interacting to form a second resonant tank through which the second coupling module receives the two-phase resonant signal.

In one embodiment, the signal demodulation output module comprises a voltage limiting unit and a filtering unit;

the voltage limiting unit is used for converting the high-frequency signal of the two-phase resonance signal into a low-frequency signal;

the filtering unit is used for processing the biphase resonance signal converted into a low-frequency signal and outputting a biphase stimulation signal.

In a second aspect, the present application also provides an implantable stimulation method employing the implantable stimulation system according to any one of the first aspects, implementing the method steps of:

the external equipment outputs a biphase resonance signal according to preset parameters and is coupled and transmitted to the implanted equipment;

the implantable device converts the biphasic resonance signal into a biphasic stimulation signal and outputs the biphasic stimulation signal to a nerve of a target object through a stimulation electrode.

In one embodiment, the method further comprises:

in the stimulation process, the pulse number of the biphase resonance signal is adjusted according to the feedback parameters of the stimulation part so as to adjust the width of the biphase stimulation signal; and/or adjusting the pulse amplitude of the biphasic resonance signal to adjust the amplitude of the biphasic stimulation signal.

In a third aspect, the present application also provides a computer device. The computer device comprises a memory storing a computer program and a processor implementing the method steps disclosed in any of the second aspects when the computer program is executed.

In a fourth aspect, the present application also provides a computer-readable storage medium. The computer readable storage medium having stored thereon a computer program which, when executed by a processor, implements the method steps disclosed in any of the second aspects.

The implantable stimulation system, method, computer device and storage medium described above have at least the following advantages:

the external device can generate a biphasic resonance signal according to preset parameters, and transmit the biphasic resonance signal to the implanted device through the wireless transmission link, and the implanted device generates a biphasic stimulation signal according to the biphasic resonance signal and outputs the biphasic stimulation signal to the nerve of the target object through the stimulation electrode. The method avoids the problem of charge accumulation, reduces possible tissue damage and stimulation electrode corrosion, prolongs the service life of the stimulation electrode and improves the reliability of long-term use.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention.

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a block diagram of an implantable stimulation system according to one embodiment;

FIG. 2 is a block diagram of an extracorporeal device in one embodiment;

FIG. 3 is a block diagram of an extracorporeal device in another embodiment;

FIG. 4 is a schematic diagram of the wiring of two first coupling units in one embodiment;

FIG. 5 is a schematic diagram of a first coil assembly according to one embodiment;

FIG. 6 is a schematic diagram of a junction of a first coil assembly in another embodiment;

FIG. 7 is a schematic diagram of a control module in one embodiment;

FIG. 8 is a schematic diagram of a control module and a schematic diagram of a current flow in another embodiment;

FIG. 9 is a timing diagram of the positive phase of the control module in one embodiment;

FIG. 10 is a block diagram of an implantable device in one embodiment;

FIG. 11 is a block diagram of an implantable device according to another embodiment;

FIG. 12 is a schematic diagram of the wiring of an implantable device in one embodiment;

FIG. 13 is a schematic diagram of a control module and another current flow diagram in another embodiment;

FIG. 14 is a timing diagram of the inverse signals of the control module in one embodiment;

FIG. 15 is a positive half waveform diagram of the input and output of an implantable device in one embodiment;

FIG. 16 is a negative half-segment waveform diagram of the input and output of an implantable device in one embodiment;

FIG. 17 is a waveform diagram of an implantable device output in one embodiment;

FIG. 18 is a waveform diagram of an implantable device output according to another embodiment;

FIG. 19 is a waveform diagram of the output of an implantable device according to another embodiment;

FIG. 20 is a flow chart of an implantable stimulation method according to one embodiment;

fig. 21 is an internal structural view of a computer device in one embodiment.

Detailed Description

Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention. It should be noted that the following embodiments and features in the embodiments may be combined with each other without conflict.

Some exemplary embodiments of the invention have been described for illustrative purposes, it being understood that the invention may be practiced otherwise than as specifically shown in the accompanying drawings.

Referring to fig. 1, in one possible embodiment, an implantable stimulation system is provided according to an embodiment of the present application, comprising: the external device and the implanted device can be coupled and connected, so that wireless energy transmission and data transmission are realized.

And the external equipment is used for outputting a biphase resonance signal according to preset parameters.

An implantable device for converting a biphasic resonance signal into a biphasic stimulation signal.

Specifically, the preset parameters include the amplitude, frequency, pulse number and other information of the output signal, and can be preset according to the physical condition of the target object, so that the external device outputs a biphase resonance signal with proper intensity, and further the implantable device outputs a corresponding biphase stimulation signal to the target object for treatment, and in the treatment process, the preset parameters are correspondingly adjusted according to the disease development of the target object, and the intensity of the stimulation signal is further adjusted, so that a better stimulation effect is achieved.

According to the implanted stimulation system, the external device can generate the biphasic resonance signal according to the preset parameters and transmit the biphasic resonance signal to the implanted device through the wireless transmission link, and the implanted device generates the biphasic stimulation signal according to the biphasic resonance signal and outputs the biphasic stimulation signal to the nerve of the target object through the stimulation electrode. The method avoids the problem of charge accumulation, reduces possible tissue damage and stimulation electrode corrosion, prolongs the service life of the stimulation electrode and improves the reliability of long-term use.

Referring to fig. 2, in one possible embodiment, an extracorporeal device comprises: the device comprises a power supply module, a control module and a first coupling module.

The power module is used for providing electric energy required by operation for the implantable stimulation system, specifically, the power module provides working voltage for the control module and the first coupling module, and single-path or multi-path stable direct current power supply can be generated according to the requirement. And after the control module is electrified, a control signal is output according to preset parameters, and the power supply module is controlled to charge or discharge the first resonant coupling module so that the first coupling module generates a biphase resonant signal and is coupled and transmitted to the implantable device.

Referring to fig. 3, optionally, the power module includes: an energy storage unit and a power manager.

And the energy storage unit is used for storing the electric energy. For example, the energy storage unit may use a single battery, or a plurality of battery packs, or an energy storage element such as a super capacitor.

And the power manager is used for converting the stored electric energy into working voltages suitable for the control module and the first coupling module. For example, the power manager may employ a low dropout linear converter (LDO), a direct current-to-direct current converter (DC-DC), or a combination of both. Further, by adjusting the component parameters of the power manager, the output voltage value of the power manager can be adjusted to adapt to various use situations.

Referring to fig. 3, optionally, the control module includes: a processor, a drive unit and a switch assembly.

And the processor is used for outputting a corresponding control signal according to the preset parameters. It should be understood that the control signal is a waveform signal having a specific duty cycle, and the duty cycle is associated with a preset parameter for controlling the charging time or the discharging time of the first coupling module. By way of example, the processor may employ a Microcontroller (MCU), a Field Programmable Gate Array (FPGA), a Complex Programmable Logic Device (CPLD), a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), or other device having the functionality described above.

And the driving unit is used for improving the intensity of the amplified control signal and improving the driving capability of the output end of the processor. For example, the driving unit may employ an operational amplifier, a diode, or an integrated chip having a large current output capability.

And the switch assembly is used for switching on or off a loop between the power supply module and the first resonance module according to the driven control signal so as to control the power supply module to charge or discharge the first resonance coupling module. The control module may be an analog switch array formed by discrete devices such as metal-semiconductor field-effect transistors (MOSFETs) or transistors (BJTs), or may be an integrated analog switch chip.

Further, in practical applications, the switch array may also be matched with devices such as multiplexers, inverters, etc. to reduce the number of output pins of the processor.

Referring to fig. 3, optionally, the first coupling module includes two first coupling units, each of which includes a first capacitor assembly and a first coil assembly, where the first capacitor assembly and the first coil assembly interact to form a first resonant tank. The first coupling units work alternately, and a variable electromagnetic field with specific frequency is generated through the first resonant circuit so as to couple the biphase resonant signal to the implantable device in a wireless mode. Illustratively, the first coil assembly employs a planar helical antenna, which may be circular, square, etc., and may be 1 or more in number. The first resonant circuit can be formed between the first capacitor component and the first coil component in a serial or parallel mode, and the number of the first capacitor component and the first coil component can be 1 or more.

Referring to fig. 4, alternatively, the capacitance of the first capacitor element may be a fixed capacitance, a variable capacitance, or a combination thereof, and the adjustment of the variable capacitance includes, but is not limited to, mechanical adjustment or voltage control adjustment. The different first coupling units can share resonance capacitance, and different coils are selected through the switch to form different resonance circuits. For example, as shown in fig. 4, L1 is one first coil component, L2 is another first coil component, the capacitor C1 and the variable capacitor Cx form a first capacitor component, and when the switch S1 is turned on and the switch S2 is turned off, L1, C1 and Cx form a resonant tank; when the switch S1 is turned off and the switch S2 is turned on, L1, C1 and Cx form another resonant circuit, so that multiplexing of resonant capacitance is achieved.

Referring to fig. 5, when the first coil assembly includes a plurality of coils, opposite induced magnetic fields are generated between two adjacent coils, so that the induced currents on the two coils are opposite in direction, thereby canceling the output signal. In view of this, the present application partially overlaps two adjacent coils, so that the induced magnetic fields in one of the coils cancel each other out, so that no induced current is generated on the coil.

Referring to fig. 6, alternatively, the number of coils included in the first coil assembly may be 2N, where N represents a natural number. The 2N coils are divided into odd groups and even groups, the two groups of coils work alternately, and all coils in each group of coils work together. The plurality of coils are distributed at different angles in space, so that the coupling efficiency reduction of the receiving coils caused by center offset can be reduced; when the first coil assembly is fixed on the body surface of the target object, a certain degree of deformation can be generated, so that the coils are different in axial direction, and the reduction of coupling efficiency of the receiving coil caused by axial deviation can be reduced. And the coils are partially overlapped with each other, so that the induction magnetic fields generated by other coils during operation are counteracted.

Illustratively, the control module employs an H-bridge circuit.

Referring to fig. 7, fig. 7 is a schematic structural diagram of a control module, and the following describes in detail the working principle of the extracorporeal device by taking the control module as an example, the H-bridge circuit in fig. 7:

the switch assembly in fig. 7 includes a switch SW1, a switch SW2, a switch SW3, a switch SW4, a switch SPDT1 and a switch SPDT2, wherein the switches SW1 to SW4 are single throw switches, the switches SPDT1 to SPDT2 are double throw switches, and the single throw switch or the double throw switch only represents the switching characteristics, and in practical use, may be composed of one or more analog devices or digital devices having the switching characteristics.

For convenience of description, another first coupling unit is labeled as a second coupling unit in fig. 7.

The processor of the control module is used for outputting a control signal which is amplified by the driving unit to control the on or off of the switch.

First entering into normal phase emission phase:

the switch SPDT1 and the switch SPDT2 enable the first coupling unit, while the switch SW2 and the switch SW3 are turned on, and the switch SW1 and the switch SW4 are turned off, and the current flows along the power module, the switch SW1, the first coupling unit, and the switch SW4, and for convenience of description, the direction is described as a forward direction.

After a period of time T, the first coupling unit is disabled through the switch SPDT1 and the switch SPDT2, and the first coupling unit starts to emit a resonance signal, and the resonance signal is recorded as a normal phase. While the second coupling unit is enabled by the switch SPDT1, the switch SPDT2 and the switch SW3 are turned on, the switch SW1 and the switch SW4 are turned off, and the current still passes through the second coupling unit in the same direction as described above.

After a period of time T, the second coupling unit is disabled through the switch SPDT1 and the switch SPDT2, and the second coupling unit starts to emit the resonant signal, and the emitted signal is still in the normal phase due to the same initial current direction. If the normal phase emission is not finished, the above steps are repeated, the switch SW2 and the switch SW3 are turned on, the switch SW1 and the switch SW4 are turned off, and the current still passes through the first coupling unit or the second coupling unit in the forward direction.

If the positive phase emission phase is finished, entering the negative phase emission phase:

the switch SPDT1 and the switch SPDT2 enable the first coupling unit, while the switch SW1 and the switch SW4 are opened, the switch SW2 and the switch SW3 are closed, and the current flows along the power module, the switch SW2, the first coupling unit and the switch SW3, and the direction is opposite to the normal phase emission phase and is recorded as the reverse direction.

After a period of time T, the first coupling unit is disabled by the switch SPDT1 and the switch SPDT2, and the first coupling unit starts to emit a resonance signal, and the resonance signal is recorded as an inverse phase. While the second coupling unit is enabled by switch SPDT1, switch SPDT2 and switch SW1 and switch SW4 are turned on and switch SW2 and switch SW3 are turned off, the current still passes through the second coupling unit in the reverse direction.

After a period of time T, the second coupling unit is disabled by the switch SPDT1 and the switch SPDT2, and the second coupling unit starts to emit the resonant signal, and the emitted signal is still inverted due to the same initial current direction. If the reverse phase emission is not finished, the above steps are repeated, the switch SW1 and the switch SW4 are turned on, the switch SW2 and the switch SW3 are turned off, and the current still passes through the first coupling unit or the second coupling unit in the reverse direction.

Referring to fig. 8, fig. 8 is a schematic diagram of a current flow of a control module, which is an exemplary H-bridge circuit formed by a plurality of transistors (MOSFETs).

The inductor L1 and the capacitor C1 form a first coupling unit, and the inductor L2 and the capacitor C2 form a second coupling unit; one transistor and one diode constitute one single-throw switching loop, for example, a transistor Q1 and a diode D1, and the four single-throw switching loops are topologically located in four quadrants, respectively; PG1-PG8 are control signals of high and low levels output by the processor through the driving unit, and the control signals are in one-to-one correspondence with the transistors.

Referring to fig. 9, in the stage t1, PG1 and PG3 are high level, PG2 and PG4 are low level, so that the transistors Q1 and Q4 are turned off, the transistors Q2 and Q3 are turned on, and the power module charges the first coupling unit, and the current direction is shown by the dotted arrow in fig. 8; PG5 and PG6 are high level, PG7 and PG8 are low level, transistors Q5-Q8 are all off, and the second coupling unit does not operate. At this time, the signal voltages U on the coil L1 and the coil L2 _TX1 、U _TX2 Are low.

In the t2 stage, PG1 and PG2 are high level, PG3 and PG4 are low level, so that the transistors Q1 to Q4 are turned off, the first coupling unit starts to generate a resonance signal, and the voltage waveform UTX1 is the positive half part of the sine wave; PG5 and PG7 are high level, PG6 and PG8 are low level, transistor Q5 and transistor Q8 are off, transistor Q6 and transistor Q7 are on, the power module charges the second coupling unit, the current direction is shown by the dotted arrow in FIG. 8, and the signal voltage UTX2 on coil L2 is low level.

In the stage t3, PG1 and PG3 are at high level, PG2 and PG4 are at low level, so that the transistor Q1 and the transistor Q4 are turned off, the transistor Q2 and the transistor Q3 are turned on, the power module charges the first coupling unit, the current direction is shown by the dotted arrow in fig. 8, and the signal voltage UTX1 on the coil L1 is at low level; PG5 and PG6 are high level, PG7 and PG8 are low level, transistors Q5-Q8 are all closed, the second coupling unit starts to generate resonance signals, and the voltage waveform UTX2 is the positive half of sine wave.

In the t4 stage, as in the t2 stage, a resonance signal is generated in the coil L1, the coil L2 starts to charge, U _TX1 、U _TX2 The waveform is shown in fig. 9.

The resonance signals generated by the two first coupling units of the first coupling module are alternately generated and always the positive half part of the sine wave, so that the signals received by the implantable device are continuous positive half-section sine waves, and the voltage waveform U of the signals is the same as that of the signals _RX As shown in fig. 9.

Referring to fig. 10, optionally, the implantable device comprises: and the second coupling module and the signal demodulation output module.

And the second coupling module is used for receiving the biphase resonance signal output by the first coupling module.

The signal demodulation output module is used for converting the biphase resonance signal into a biphase stimulation signal, and converting the coupled spatial electromagnetic wave signal into a stimulation waveform signal which is finally output. Illustratively, the signal demodulation output module employs a low pass filter circuit.

Referring to fig. 11, optionally, the second coupling module includes a second coil and a second capacitor, where the second coil and the second capacitor interact to form a second resonant circuit, and the second coupling module receives the two-phase resonant signal through the second resonant circuit. The second coupling module may receive a varying electromagnetic field of a specific frequency through a resonance principle and generate an induced electrical signal. The second coil of the second coupling module may be a planar spiral antenna or a wire wound inductance, may be circular, square or other shape, and may be 1 or more in number. The second capacitor assembly and the second coil can form a second resonant circuit in a serial or parallel mode, and the number of the second capacitor assembly and the second coil can be 1 or more. Illustratively, the capacitance that forms the second capacitive component may be a fixed capacitance value capacitance, a variable capacitance, or a combination of both, and the adjustment of the variable capacitance includes, but is not limited to, a mechanical adjustment or a voltage controlled adjustment.

Optionally, the signal demodulation output module includes a voltage limiting unit and a filtering unit.

And the voltage limiting unit is used for limiting the amplitude of the biphase resonance signal. Illustratively, the voltage limiting unit employs a zener diode to limit excessive voltage stimulus.

And the filtering unit is used for converting the high-frequency signal of the biphase resonance signal into a low-frequency signal and outputting a biphase stimulation signal. The filtering unit adopts a low-pass circuit, and can be independently formed by a capacitor or a filtering network formed by cascading the capacitor and the resistor.

Referring to fig. 12, fig. 12 is a schematic diagram of a wiring diagram of an implantable device, wherein a coil L3 and a capacitor C3 form a second coupling module, and receive a two-phase resonance signal output by the first coupling module; the voltage-limiting unit of the voltage-stabilizing diode D10 is used for selecting the model of the diode according to the requirement so as to limit the voltage in a proper range; the capacitor C4 is a filtering unit, and filters the voltages at two ends of the zener diode D10, so that the voltage of the input electrode is more stable.

Referring to fig. 13, fig. 13 is a schematic diagram showing another current flow direction of the control module, which has the same structure as that of fig. 8, but only the current flow direction is different.

Referring to fig. 14, at stage t6, PG1 and PG3 are low, PG2 and PG4 are high, so that the transistors Q1 and Q4 are turned on, the transistors Q2 and Q3 are turned off, and the power module charges the first coupling unit, and the current direction is shown by the dotted arrow in fig. 13; PG5 and PG6 are high level, PG7 and PG8 are low level, transistors Q5-Q8 are all off, and the second coupling unit does not operate. At this time, the signal voltages U on the coil L1 and the coil L2 _TX1 、U _TX2 Are low.

In the stage t7, PG1 and PG2 are high, PG3 and PG4 are low, so that the transistors Q1 to Q4 are turned off, and the first coupling unit starts to generate a resonance signal, because the initial current direction is opposite to the current direction in fig. 8, the polarity of the generated voltage waveform is also opposite, and the generated voltage waveform is a sine wave negative half part; PG5 and PG7 are low level, PG6 and PG8 are high level, transistor Q5 and transistor Q8 are on, transistor Q6 and transistor Q7 are off, the power supply module charges the second coupling unit, the current direction is shown by the dotted arrow in FIG. 13, the signal voltage U on coil L2 _TX2 Is low.

In the stage t8, PG1 and PG3 are low, PG2 and PG4 are high, so that the transistors Q1 and Q4 are turned on, the transistors Q2 and Q3 are turned off, the power supply module charges the first coupling unit, and the current direction is shown by the dotted arrow in FIG. 13, and the signal voltage U on the coil L1 is equal to the signal voltage U _TX1 Is low; PG5 and PG6 are high, PG7 and PG8 are low, the transistors Q5-Q8 are all closed, the second coupling unit starts to generate resonance signals, and the initial current direction is opposite to that in FIG. 8, so that the polarity of the generated voltage waveform is opposite, and the generated voltage waveform is a sine wave negative half part.

In the stage t9, as in the stage t7, a resonance signal is generated in the coil L1, the coil L2 starts to be charged, U _TX1 、U _TX2 The waveform is shown in fig. 14.

The resonance signals generated by the two first coupling units of the first coupling module are alternately generated and always are the negative half part of the sine wave, so that the signals received by the implantable device are continuous negative half-section sine waves, and the voltage waveform U of the signals is the same as the voltage waveform U of the signals _RX As shown in fig. 14.

Referring to fig. 15 and 16, fig. 15 is a waveform diagram of a positive half sine wave received by an implantable device, where the waveform is processed by a signal demodulation output module, and then high-frequency components are filtered out, so as to become a positive half low-frequency stimulation signal actually required. Fig. 16 is a waveform diagram of a negative half-segment sine wave received by the implantable device, where the waveform is processed by the signal demodulation output module, and then the high-frequency component is filtered out, so that the negative half-segment low-frequency stimulation signal is actually needed.

Referring to fig. 17, it can be seen that the finally generated stimulation signal can be in positive and negative phases by controlling the output time sequence of the external device, so as to reduce the stimulation to the organism tissue and reduce the corrosion degree of the electrode. Since the positive phase signal produces an action potential, inducing a stimulating effect, and the inverted signal is used to cancel the accumulated charge, a delayed biphasic balance signal may also be produced, illustratively by controlling the interval between positive and negative phases, in order to avoid the inverted signal interfering with the stimulating action. It should be appreciated that the interval may be adjusted according to the actual situation of the target object.

The course of treatment of the target subject may also be monitored, for example, by controlling the width and amplitude of the stimulation signal in accordance with feedback parameters at the stimulation site such that the total area of the inverted signal and the forward phase signal is equal or close, thereby rendering the stimulation signal as a biphasic charge balance slow inversion or a biphasic charge balance fast inversion. Alternatively, the total area of the inverted signal and the positive phase signal can be unequal by controlling the width and the amplitude of the stimulation signal, and the final stimulation signal is presented as a biphasic charge imbalance inversion. Wherein the feedback parameter includes at least one of a perception threshold, an action potential, a biological tissue tolerance level, and an electrode erosion level.

Alternatively, the width of the biphasic stimulation signal may be adjusted by varying the number of pulses produced by the extracorporeal device. Taking the high-frequency pulse with the output frequency f=1 MHz of the external device as an example, the forward pulse width W= (1/f)/2=0.5 us; if a stimulus signal of width 100us is expected to be generated, the extracorporeal device needs to generate at least 100/0.5=200 pulses.

The amplitude of the biphasic stimulation signal is positively correlated with the amplitude of the resonance signal of the extracorporeal device, so that the amplitude of the stimulation signal can be adjusted by changing the amplitude of the resonance signal output by the extracorporeal device. The amplitude of the resonance signal of the external device can be adjusted by changing the power supply voltage or the charging time. Further, changing the charging voltage can be achieved by changing the output of the power module; changing the charge time may be accomplished by changing the on time of the switch array.

Referring to fig. 18, by changing the width and amplitude of the inversion signal, an inversion signal with low amplitude, large width, and total area equal to or close to the positive phase signal can be obtained, and the final stimulus signal appears as a biphasic charge balance slow inversion.

Referring to fig. 19, the width and amplitude of the inversion signal are changed such that the amplitude gradually decreases and the total area is kept equal or close to the positive phase signal, and the final stimulus signal appears as a biphasic charge balance rapid inversion.

In the above embodiment, the feedback parameters of the stimulation portion are obtained by monitoring the treatment process of the target object, and the width and the amplitude of the stimulation signal are controlled according to the feedback parameters, so as to perform accurate stimulation on the target object. The various modules in the implantable stimulation system described above may be implemented in whole or in part by software, hardware, and combinations thereof. The above modules may be embedded in hardware or may be independent of a processor in the computer device, or may be stored in software in a memory in the computer device, so that the processor may call and execute operations corresponding to the above modules.

Based on the same inventive concept, the embodiments of the present application also provide an implantable stimulation method for implementing the above-mentioned implantable stimulation system. The implementation of the solution provided by this method is similar to that described in the above method, so specific limitations in one or more embodiments of the implantable stimulation system provided below may be found in the limitations of the implantable stimulation method described above, and will not be described in detail herein.

Referring to fig. 20, in one possible embodiment, an implantable stimulation method is provided according to an embodiment of the present application, including:

in step S2002, the external device outputs a biphase resonance signal according to the preset parameters, and couples and transmits the biphase resonance signal to the implantable device.

In step S2004, the implantable device converts the biphasic resonance signal into a biphasic stimulation signal, and outputs the biphasic stimulation signal to the nerve of the target object through the stimulation electrode.

Specifically, the extracorporeal device comprises: the device comprises a power supply module, a control module and a first coupling module.

A power module provides power required for operation of an implantable stimulation system, comprising: an energy storage unit and a power manager. The energy storage unit is used for storing electric energy; and the power manager is used for converting the stored electric energy into working voltages suitable for the control module and the first coupling module.

Optionally, the control module includes: a processor, a drive unit and a switch assembly.

The processor is used for outputting corresponding control signals according to preset parameters; the driving unit is used for improving the intensity of the amplified control signal and the driving capability of the output end of the processor; and the switch assembly is used for switching on or off a loop between the power supply module and the first resonance module according to the driven control signal so as to control the power supply module to charge or discharge the first resonance coupling module.

The first coupling module comprises two first coupling units, each first coupling unit comprises a first capacitor component and a first coil component, and the first capacitor component and the first coil component interact to form a first resonant circuit. The first coupling units work alternately, and a variable electromagnetic field with specific frequency is generated through the first resonant circuit so as to couple the biphase resonant signal to the implantable device in a wireless mode.

The implantable device comprises: and the second coupling module and the signal demodulation output module.

The second coupling module is used for receiving the biphase resonance signal output by the first coupling module and comprises a second coil and a second capacitor assembly, the second coil and the second capacitor assembly interact to form a second resonance loop, and the second coupling module receives the biphase resonance signal through the second resonance loop.

The signal demodulation output module is used for converting the biphase resonance signal into a biphase stimulation signal, and converting the coupled spatial electromagnetic wave signal into a stimulation waveform signal which is finally output.

And the voltage limiting unit is used for limiting the amplitude of the biphase resonance signal.

And the filtering unit is used for converting the high-frequency signal of the biphase resonance signal into a low-frequency signal and outputting a biphase stimulation signal.

According to the implanted stimulation method, the external device can generate the biphasic resonance signal according to the preset parameters and transmit the biphasic resonance signal to the implanted device through the wireless transmission link, and the implanted device generates the biphasic stimulation signal according to the biphasic resonance signal and outputs the biphasic stimulation signal to the nerve of the target object through the stimulation electrode. The method avoids the problem of charge accumulation, reduces possible tissue damage and stimulation electrode corrosion, prolongs the service life of the stimulation electrode and improves the reliability of long-term use.

In one possible embodiment, the implantable stimulation method of the embodiments of the present application further comprises:

in the stimulation process, the pulse number of the biphase resonance signal is adjusted according to the feedback parameters of the stimulation part so as to adjust the width of the biphase stimulation signal; and/or adjusting the pulse amplitude of the biphasic resonance signal to adjust the amplitude of the biphasic stimulation signal. Wherein the feedback parameter includes at least one of a perception threshold, an action potential, a biological tissue tolerance level, and an electrode erosion level.

Optionally, the adjusting manner of the width of the biphasic stimulation signal includes: the number of pulses generated by the extracorporeal device is changed.

Optionally, the adjusting manner of the amplitude of the biphasic stimulation signal includes: the amplitude of the resonance signal output by the extracorporeal device is changed. Further, the amplitude of the resonance signal of the extracorporeal device may be adjusted by varying the supply voltage, or the charging time. Changing the charging voltage can be achieved by changing the output of the power supply module; changing the charge time may be accomplished by changing the on time of the switch array.

According to the implanted stimulation method, the external device can generate the biphasic resonance signal according to the preset parameters and transmit the biphasic resonance signal to the implanted device through the wireless transmission link, and the implanted device generates the biphasic stimulation signal according to the biphasic resonance signal and outputs the biphasic stimulation signal to the nerve of the target object through the stimulation electrode. The method avoids the problem of charge accumulation, reduces possible tissue damage and stimulation electrode corrosion, prolongs the service life of the stimulation electrode and improves the reliability of long-term use. Meanwhile, in the stimulation process, the feedback parameters of the stimulation part are obtained by monitoring the treatment process of the target object, and the width and the amplitude of the stimulation signal are controlled according to the feedback parameters so as to accurately stimulate the target object.

It should be understood that, although the steps in the flowcharts related to the embodiments described above are sequentially shown as indicated by arrows, these steps are not necessarily sequentially performed in the order indicated by the arrows. The steps are not strictly limited to the order of execution unless explicitly recited herein, and the steps may be executed in other orders. Moreover, at least some of the steps in the flowcharts described in the above embodiments may include a plurality of steps or a plurality of stages, which are not necessarily performed at the same time, but may be performed at different times, and the order of the steps or stages is not necessarily performed sequentially, but may be performed alternately or alternately with at least some of the other steps or stages.

In one possible embodiment, a computer device is provided, which may be a terminal, and its internal structure may be as shown in fig. 21. The computer device includes a processor, a memory, an input/output interface, a communication interface, a display unit, and an input means. The processor, the memory and the input/output interface are connected through a system bus, and the communication interface, the display unit and the input device are connected to the system bus through the input/output interface. Wherein the processor of the computer device is configured to provide computing and control capabilities. The memory of the computer device includes a non-volatile storage medium and an internal memory. The non-volatile storage medium stores an operating system and a computer program. The internal memory provides an environment for the operation of the operating system and computer programs in the non-volatile storage media. The input/output interface of the computer device is used to exchange information between the processor and the external device. The communication interface of the computer device is used for carrying out wired or wireless communication with an external terminal, and the wireless mode can be realized through WIFI, a mobile cellular network, NFC (near field communication) or other technologies. The computer program is executed by a processor to implement an implantable stimulation method. The display unit of the computer device is used for forming a visual picture, and can be a display screen, a projection device or a virtual reality imaging device. The display screen can be a liquid crystal display screen or an electronic ink display screen, and the input device of the computer equipment can be a touch layer covered on the display screen, can also be a key, a track ball or a touch pad arranged on the shell of the computer equipment, and can also be an external keyboard, a touch pad or a mouse and the like.

It will be appreciated by those skilled in the art that the structure shown in fig. 21 is merely a block diagram of a portion of the structure associated with the present application and is not limiting of the computer device to which the present application applies, and that a particular computer device may include more or fewer components than shown, or may combine some of the components, or have a different arrangement of components.

In a possible embodiment, a computer device is provided, comprising a memory and a processor, the memory having stored therein a computer program, which processor, when executing the computer program, implements the method steps of the implantable stimulation method described above.

In a possible embodiment, a computer-readable storage medium is provided, on which a computer program is stored which, when being executed by a processor, implements the method steps of the implantable stimulation method described above.

In a possible embodiment, a computer program product is provided, comprising a computer program which, when executed by a processor, implements the method steps of the implantable stimulation method described above.

It should be noted that, the user information (including, but not limited to, user equipment information, user personal information, etc.) and the data (including, but not limited to, data for analysis, stored data, presented data, etc.) referred to in the present application are information and data authorized by the user or sufficiently authorized by each party, and the collection, use and processing of the related data are required to comply with the related laws and regulations and standards of the related countries and regions.

Those skilled in the art will appreciate that implementing all or part of the above described methods may be accomplished by way of a computer program stored on a non-transitory computer readable storage medium, which when executed, may comprise the steps of the embodiments of the methods described above. Any reference to memory, database, or other medium used in the various embodiments provided herein may include at least one of non-volatile and volatile memory. The nonvolatile Memory may include Read-Only Memory (ROM), magnetic tape, floppy disk, flash Memory, optical Memory, high density embedded nonvolatile Memory, resistive random access Memory (ReRAM), magnetic random access Memory (Magnetoresistive Random Access Memory, MRAM), ferroelectric Memory (Ferroelectric Random Access Memory, FRAM), phase change Memory (Phase Change Memory, PCM), graphene Memory, and the like. Volatile memory can include random access memory (Random Access Memory, RAM) or external cache memory, and the like. By way of illustration, and not limitation, RAM can be in the form of a variety of forms, such as static random access memory (Static Random Access Memory, SRAM) or dynamic random access memory (Dynamic Random Access Memory, DRAM), and the like. The databases referred to in the various embodiments provided herein may include at least one of relational databases and non-relational databases. The non-relational database may include, but is not limited to, a blockchain-based distributed database, and the like. The processors referred to in the embodiments provided herein may be general purpose processors, central processing units, graphics processors, digital signal processors, programmable logic units, quantum computing-based data processing logic units, etc., without being limited thereto.

The technical features of the above embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples only represent a few embodiments of the present application, which are described in more detail and are not to be construed as limiting the scope of the present application. It should be noted that it would be apparent to those skilled in the art that various modifications and improvements could be made without departing from the spirit of the present application, which would be within the scope of the present application. Accordingly, the scope of protection of the present application shall be subject to the appended claims.

Claims

1. An implantable stimulation system, the system comprising: an extracorporeal device and an implantable device coupled;

2. The system of claim 1, wherein the extracorporeal device comprises: the device comprises a power supply module, a control module and a first coupling module;

3. The system of claim 2, wherein the power module comprises: an energy storage unit and a power manager;

the energy storage unit is used for storing electric energy;

4. The system of claim 2, wherein the control module comprises: a processor, a drive unit and a switch assembly;

the driving unit is used for amplifying the intensity of the control signal;

5. The system of claim 4, wherein the control module employs an H-bridge circuit.

6. The system of claim 2, wherein the first coupling module comprises two first coupling units, each of the first coupling units comprising a first capacitive component and a first coil component, the first capacitive component and the first coil component interacting to form a first resonant tank;

7. The system of claim 6, wherein the first coil assembly comprises a plurality of coils, adjacent two of the coils partially overlapping.

8. The system of claim 1, wherein the implantable device comprises: the second coupling module and the signal demodulation output module;

the second coupling module is used for receiving the biphase resonance signal;

9. The system of claim 8, wherein the second coupling module comprises a second coil and a second capacitive component that interact to form a second resonant tank through which the second coupling module receives the two-phase resonant signal.

10. The system of claim 8, wherein the signal demodulation output module comprises a voltage limiting unit and a filtering unit;

the voltage limiting unit is used for limiting the amplitude of the biphase resonance signal;

the filtering unit is used for converting the high-frequency signal of the biphase resonance signal into a low-frequency signal and outputting a biphase stimulation signal.

11. An implantable stimulation method characterized in that the following method steps are implemented with an implantable stimulation system according to any one of claims 1-10:

12. The method as recited in claim 11, further comprising:

13. A computer device comprising a memory and a processor, the memory storing a computer program, characterized in that the processor implements the steps of the method of any of claims 11 to 12 when the computer program is executed.

14. A computer readable storage medium, on which a computer program is stored, characterized in that the computer program, when being executed by a processor, implements the steps of the method of any of claims 11 to 12.