Impulse response dynamic impedance measurement and regulation device, method and storage medium

Abstract

The application discloses a kind of pulse response type dynamic impedance measurement and regulation device, comprising: pulse generation unit, control unit, acquisition module;Control unit sends the control signal including operating parameter to pulse generation unit;Pulse generation unit generates low-voltage pulse, and low-voltage pulse is applied in load both ends;Module synchronous measurement voltage and current in load both ends, and voltage and current are detected, while analog signal is converted into digital signal;Control unit stores and transports the digital signal collected, and obtains impedance value according to voltage and current.This application is measured by applying real-time voltage pulse to ablation tissue, and the real-time impedance change of ablation tissue is calculated according to the voltage and current in the two ends of ablation tissue, so as to realize the real-time evaluation of the ablation effect of target area.The device can be used with high-voltage pulse ablation equipment through interface unit, realize the feedback adjustment of high-voltage pulse parameters, and more optimized ablation effect can be obtained in shorter time.

Description

Technical Field

[0001] This invention relates to the field of ablation equipment technology, and in particular to a pulse-response dynamic impedance measurement and control device, method and storage medium. Background Technology

[0002] High-voltage short-pulse electric field ablation is a novel physical therapy technique that has emerged in recent years. This technique generates a high-voltage pulsed electric field with a pulse width of microseconds or nanoseconds, releasing extremely high energy in a short period. This energy causes numerous irreversible micropores to form in cell membranes and even intracellular organelles, such as the endoplasmic membrane, mitochondria, and the cell nucleus, leading to apoptosis of diseased cells and achieving the desired therapeutic effect. Based on the theory of irreversible electroporation, pulsed electric field technology is currently being used to treat diseases such as tumors and arrhythmias.

[0003] Real-time visualization assessment of ablation effects is crucial for effective treatment. However, the impact of pulsed electric field parameters on tumor ablation during treatment remains largely based on empirical prediction. The implementation and evaluation of high-voltage pulsed electric field ablation effects and the dynamic control of treatment parameters are still unresolved issues in clinical practice.

[0004] Irreversible electroporation-induced cell death requires a certain amount of time, and conventional imaging techniques have a time lag in assessing tissue functional status, which cannot meet the needs of real-time efficacy assessment.

[0005] In conclusion, how to evaluate the ablation effect is a problem that needs to be solved. Summary of the Invention

[0006] The purpose of this invention is to provide a pulse-response dynamic impedance measurement and control device, method, and storage medium to address the need for real-time efficacy evaluation in existing non-responsive settings and methods.

[0007] To solve the above-mentioned technical problems, the present invention provides a pulse response dynamic impedance measurement and control device, comprising: a pulse generation unit, a control unit, and a data acquisition module;

[0008] The control unit sends control signals, including operating parameters, to the pulse generation unit;

[0009] The pulse generation unit generates a low-voltage pulse, which is applied across the load.

[0010] The acquisition module synchronously measures the voltage and current at both ends of the load, detects the voltage and current, and converts the analog signal into a digital signal.

[0011] The control unit stores and transmits the acquired digital signals and obtains the impedance value based on the voltage and current.

[0012] Furthermore, it also includes an interface unit, which sets the operating parameters of the pulse generation unit.

[0013] Furthermore, the interface unit is also used to feed back the impedance value to the high-voltage pulse ablation device to realize feedback on the high-voltage pulse ablation results.

[0014] Furthermore, the pulse generation unit includes a DC charging power supply module and a pulse shaping topology module;

[0015] The pulse shaping topology network is composed of a half-bridge structure.

[0016] Furthermore, the control unit includes an embedded control unit and a logic control unit;

[0017] The embedded control unit includes a microprocessor, and the logic control unit includes a programmable logic device; the control unit adopts a dual-core structure of "STM32+FPGA".

[0018] Furthermore, it also includes a system power supply unit, including a 220V to 5V, 12V, and 24V switching power supply module;

[0019] The acquisition module includes a voltage acquisition unit, a current acquisition unit, and a dual-channel high-speed A / D module. The voltage acquisition unit includes a voltage divider unit, a signal conditioning unit, and a data measurement unit. It uses a resistor divider to output a voltage value of 0-5V for acquisition by the dual-channel high-speed A / D module. The output current is converted into a voltage signal by a current sensor for acquisition by the high-speed A / D module. The current acquisition module uses a current sensor, model HCS-LSP-6A, with an operating voltage of 5V, a maximum current measurement range of -6A to +6A, and an output voltage range of 2.5V-2V to 2.5V+2V.

[0020] The dual-channel high-speed A / D module uses the AD9226 acquisition chip, which has a precision of 12 bits and a maximum sampling rate of 65MPS.

[0021] This invention also provides a pulse-response dynamic impedance measurement and control method, comprising:

[0022] The control unit sends control signals, including operating parameters, to the pulse generation unit;

[0023] The pulse generation unit generates a low-voltage pulse, which is applied across the load.

[0024] The acquisition module simultaneously measures the voltage and current across the load, detects the voltage and current, and converts the analog signals into digital signals.

[0025] The control unit stores and transmits the acquired digital signals and obtains the impedance value based on the voltage and current.

[0026] Furthermore, the interface unit sets the operating parameters of the pulse generation unit; the pulse generation unit can generate low-voltage measurement square wave pulses with adjustable parameters such as amplitude, pulse width, frequency, and number. Its pulse voltage amplitude is adjustable from 10 to 100V, and its pulse width is adjustable from 5 to 100μs. At the same time, the pulse leading edge and trailing edge are both less than 50ns, which can match the requirements of impedance measurement for different tissue ablation for measurement pulse parameters.

[0027] Furthermore, the interface unit feeds back the impedance value to the high-voltage pulse ablation device to provide feedback on the high-voltage pulse ablation results.

[0028] The present invention also provides a computer-readable storage medium storing a computer program, which, when executed by a processor, implements the steps of the impulse response dynamic impedance measurement and control method described above.

[0029] The pulse-response dynamic impedance measurement device and method provided by this invention applies a real-time measured voltage pulse to the ablated tissue and calculates the real-time impedance change of the ablated tissue based on the voltage and current across the ablated tissue, thereby achieving real-time evaluation of the ablation effect in the target area. Simultaneously, the device can be used in conjunction with a high-voltage pulse ablation device via an interface unit to achieve feedback adjustment of the high-voltage pulse parameters, enabling more optimized ablation results in a shorter time. Attached Figure Description

[0030] To more clearly illustrate the technical solutions of the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0031] Figure 1 This is a frame diagram of a pulse-response dynamic impedance measurement device according to the present invention. Detailed Implementation

[0032] The core of this invention is to provide a pulse-response dynamic impedance measurement and control device, method, and storage medium, which effectively solves the problem of real-time efficacy evaluation in existing non-responsive settings and methods.

[0033] To enable those skilled in the art to better understand the present invention, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are merely some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0034] This invention discovers that by measuring changes in the resistance or impedance spectrum of ablated tissue, but in practical use, most devices lack the function of real-time impedance measurement, especially during high-voltage pulse application, it is necessary to measure the changes in tissue impedance before and after the application of the high-voltage pulse. Although the high-voltage pulse generation circuit and the low-voltage measurement pulse circuit can be integrated into a single system, and the high-voltage pulse treatment output and low-voltage pulse impedance measurement function can be switched by controlling a switch or relay, this method increases the complexity of the system structure and control.

[0035] Please refer to Figure 1 The present invention provides a pulse response dynamic impedance measurement and control device, comprising: a pulse generation unit, a control unit, and a data acquisition module;

[0036] The control unit sends control signals, including operating parameters, to the pulse generation unit;

[0037] The pulse generation unit generates a low-voltage pulse, which is applied across the load.

[0038] The acquisition module synchronously measures the voltage and current at both ends of the load, detects the voltage and current, and converts the analog signal into a digital signal.

[0039] The control unit stores and transmits the acquired digital signals and obtains the impedance value based on the voltage and current.

[0040] The load can be the ablated tissue, i.e., the voltage and current across the ablated tissue are measured, and the impedance value is obtained based on the voltage and current. Obtaining the impedance value by measuring the pulse voltage and current lays the foundation for the prediction and real-time detection of individualized pulse ablation under the action of a pulsed electric field.

[0041] Preferably, the device further includes an interface unit, which sets the operating parameters of the pulse generation unit.

[0042] The interface unit is also used to feed back the impedance value to the high-voltage pulse ablation device to realize feedback on the high-voltage pulse ablation results.

[0043] Specifically, the interface unit includes a pulse output interface, button and switch interfaces, serial port, and external trigger interface.

[0044] The button and opening interface communicate with the user-operated buttons and switches to set the operating parameters of the pulse generation unit.

[0045] The pulse output interface is used for data communication with the host computer or high-voltage pulse therapy device. The serial port and external trigger interface are used for audible and visual alarm indications when the device malfunctions.

[0046] The pulse generation unit includes a DC charging power supply module and a pulse shaping topology module; the pulse shaping topology network is composed of a half-bridge structure. The pulse generation unit can generate low-voltage measurement square wave pulses with flexible adjustable parameters such as amplitude, pulse width, frequency, and number. Its pulse voltage amplitude is adjustable from 10-100V, and the pulse width is adjustable from 5-100μs. At the same time, the pulse leading edge and trailing edge are both less than 50ns, which can match the requirements of impedance measurement for different tissue ablation processes.

[0047] Due to the impedance of the interface between the electrode and biological tissue (electrode-electrolyte interface), the low-frequency signal, which is most sensitive to electroporation, may cause measurement distortion due to interference from the interface impedance. Therefore, the amplitude of the low-voltage measurement signal must be large enough to force the electrochemical reaction at the electrode interface, changing the electrode behavior from capacitive to resistive, thus negligible the influence of interface impedance. Simultaneously, the amplitude of the measurement pulse voltage must be low enough to avoid errors in impedance measurement caused by the electroporation effect in the tissue. The voltage field strength of the low-voltage measurement signal generally does not exceed 100V / cm. Therefore, the power supply module selected in this invention has an adjustable output voltage of 0-100V, which can be adjusted from 0-5V via an analog modulation interface.

[0048] To achieve a pulse rise time of less than 50ns and a pulse fall time of less than 100ns, a CREE silicon carbide power MOSFET, model C2M0080120, was selected. Its rise time is 13.6ns, fall time is 18.4ns, maximum operating voltage is 1200V, and maximum pulse current is 80A, all of which meet the design requirements. An EPCOS film capacitor was used for energy storage, and multiple fast recovery diodes were connected in series to resist the impact of the high-voltage pulse on the real-time detection pulse system. First, the power supply module charges the energy storage capacitor. Then, through a synchronous control module, a nanosecond-level fast pulse is output to the electrode needle before and after the application of the high-voltage pulse. Based on the voltage and loop current information on the tumor tissue, the impedance information of the tumor tissue can be obtained. Combined with the specific dielectric characteristics of the tissue, the ablation effect is judged, and the applied high-voltage pulse width and electrode needle depth are adjusted accordingly to achieve real-time optimization of tumor ablation overshoot.

[0049] The control unit includes embedded control units and logic control units.

[0050] The embedded control unit includes a microprocessor, and the logic control unit includes programmable logic devices. The control unit adopts a dual-core architecture of "STM32 + FPGA". This meets the project's testing, measurement, and control requirements. The "ARM" core uses the STM32F407IGT6 with a Cortex-M4 core, which not only features a 168MHz clock speed, FPU floating-point unit, and DSP instruction set, but also multiple peripherals, interfaces, and I / O capabilities. The "ARM" core acts as the CPU, responsible for function implementation, event processing, and interface functions. The "FPGA" core uses the Altera Cyclone series fourth-generation product EP4CE10F17C8N, which has advantages such as low power consumption, high performance, abundant resources, and ease of use. The "FPGA" core acts as the "logic device", responsible for parallel processing, real-time processing, and logic management functions.

[0051] This device also includes a system power supply unit, including a 220V to 5V, 12V, and 24V switching power supply module;

[0052] The acquisition module includes a voltage acquisition unit, a current acquisition unit, and a dual-channel high-speed A / D module. The voltage acquisition unit includes a voltage divider unit, a signal conditioning unit, and a data measurement unit. It uses a resistor divider to output a voltage value of 0-5V for the A / D module to acquire. The output current is converted into a voltage signal by a current sensor for acquisition by the high-speed A / D module. The current acquisition module uses a current sensor, model HCS-LSP-6A, with an operating voltage of 5V, a maximum current measurement range of -6A to +6A, and an output voltage range of 2.5V-2V to 2.5V+2V.

[0053] The dual-channel high-speed A / D module uses the AD9226 acquisition chip, which has a precision of 12 bits and a maximum sampling rate of 65MPS.

[0054] This device employs a modular structure, applying real-time measured voltage pulses to the ablation tissue via electrodes. The actual impedance is calculated based on the voltage and current across the ablation tissue, enabling real-time evaluation of the ablation effect on the target area. Simultaneously, the module can be used in conjunction with a high-voltage pulse ablation device via external communication and synchronous trigger interfaces. The measured real-time voltage, current, and impedance values ​​are fed back to the high-voltage pulse ablation device, allowing for feedback adjustment of high-voltage pulse parameters and electrode needle position information, thereby achieving a more uniform ablation effect in a shorter time.

[0055] This device employs a pulse measurement system designed with silicon carbide switching transistors, which can generate square wave pulses with adjustable amplitude, pulse width, frequency, and number of pulses. At the same time, the pulse leading edge and trailing edge are both less than 50ns, which can match the requirements of impedance measurement for different tissue ablation processes.

[0056] This device employs a current sensor with high tracking accuracy and fast response time, and a high-precision, high-speed A / D acquisition chip. It adopts a dual-controller core control architecture to achieve synchronous acquisition and transmission of voltage and current data. The sampling time and data acquisition depth can be set through software, and the data processing algorithm can be combined to improve the stability and accuracy of the data.

[0057] This invention also provides a pulse-response dynamic impedance measurement and control method, comprising:

[0058] The control unit sends control signals, including operating parameters, to the pulse generation unit;

[0059] The pulse generation unit generates a low-voltage pulse, which is applied across the load.

[0060] The acquisition module simultaneously measures the voltage and current across the load, detects the voltage and current, and converts the analog signals into digital signals.

[0061] The control unit stores and transmits the acquired digital signals and obtains the impedance value based on the voltage and current.

[0062] Furthermore, the interface unit sets the operating parameters of the pulse generation unit.

[0063] Furthermore, the interface unit feeds back the impedance value to the high-voltage pulse ablation device to provide feedback on the high-voltage pulse ablation results.

[0064] Before transmitting and receiving data, the interface unit also includes start-up and system initialization. Afterwards, the interface unit receives commands and parses them to obtain the operating parameters of the pulse generation unit.

[0065] The control unit then sends control signals, including operating parameters, to the pulse generation unit;

[0066] The pulse generation unit outputs a low-voltage pulse according to the set working parameters of the low-voltage measurement pulse. The pulse generation unit can generate low-voltage measurement square wave pulses with adjustable parameters such as amplitude, pulse width, frequency, and number. The pulse voltage amplitude is adjustable from 10 to 100V, and the pulse width is adjustable from 5 to 100μs. At the same time, the pulse leading edge and trailing edge are both less than 50ns, which can match the requirements of impedance measurement for different tissue ablation for the measurement pulse parameters.

[0067] The acquisition module synchronously measures or acquires the voltage and current across the load; the acquisition module converts the acquired voltage and current data into digital signals and stores them in the control unit;

[0068] The control unit calculates the load impedance based on the voltage and current values ​​and feeds it back to the high-voltage pulse ablation device to provide feedback on the high-voltage pulse ablation results.

[0069] The present invention also provides a computer-readable storage medium storing a computer program, which, when executed by a processor, implements the steps of the impulse response dynamic impedance measurement and control method described above.

[0070] The method provided by this invention applies a voltage pulse measured in real time to the ablation tissue, calculates the actual impedance based on the voltage and current across the ablation tissue, and achieves real-time evaluation of the ablation effect on the target area. Simultaneously, the device can be used in conjunction with a high-voltage pulse ablation device via an interface unit to achieve feedback adjustment of the high-voltage pulse parameters, thereby obtaining a more uniform ablation effect in a shorter time.

[0071] A specific embodiment of the present invention also provides a computer-readable storage medium storing a computer program, which, when executed by a processor, implements the steps of the above-described impulse response dynamic impedance measurement and control method.

[0072] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the apparatus disclosed in the embodiments, since it corresponds to the method disclosed in the embodiments, the description is relatively simple; relevant parts can be referred to in the method section.

[0073] Those skilled in the art will further recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, computer software, or a combination of both. To clearly illustrate the interchangeability of hardware and software, the components and steps of the various examples have been generally described in terms of functionality in the foregoing description. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementations should not be considered beyond the scope of this invention.

[0074] The steps of the methods or algorithms described in conjunction with the embodiments disclosed herein can be implemented directly by hardware, a software module executed by a processor, or a combination of both. The software module can be located in random access memory (RAM), main memory, read-only memory (ROM), electrically programmable ROM, electrically erasable programmable ROM, registers, hard disk, removable disk, CD-ROM, or any other form of storage medium known in the art.

[0075] The pulse-response dynamic impedance measurement and control device and method, as well as the computer-readable storage medium provided by this invention, have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the embodiments above are merely for the purpose of helping to understand the method and core ideas of this invention. It should be noted that those skilled in the art can make various improvements and modifications to this invention without departing from its principles, and these improvements and modifications also fall within the protection scope of the claims of this invention.

Claims

1. A pulse-response dynamic impedance measurement and control device, characterized in that, include: Pulse generation unit, control unit, acquisition module, interface unit; The control unit sends control signals, including operating parameters, to the pulse generation unit; The pulse generation unit generates a low-voltage pulse, which is applied across the load terminals; the pulse generation unit includes a DC charging power supply module. The acquisition module synchronously measures the voltage and current at both ends of the load, detects the voltage and current, and converts the analog signal into a digital signal. The control unit stores and transmits the acquired digital signals, and obtains the impedance value based on the voltage and current. The interface unit sets the operating parameters of the pulse generation unit; Used to feed back the impedance value to the high-voltage pulse ablation device, so as to realize the feedback of the high-voltage pulse ablation results; The DC charging power module charges the energy storage capacitor and outputs a nanosecond-level fast pulse to the electrode pins at both ends of the load before and after the high voltage pulse is applied, respectively, to obtain impedance information. The applied high-voltage pulse width and electrode needle depth are adjusted according to the impedance information. The nanosecond-level fast pulse is a low-voltage measurement square wave pulse with an adjustable pulse voltage amplitude of 10-100V and an adjustable pulse width of 5-100μs. The leading and trailing edges of the pulse are both less than 50ns. The voltage field strength of the nanosecond-level fast pulse does not exceed 100V / cm.

2. The pulse response dynamic impedance measurement and control device as described in claim 1, characterized in that, The pulse generation unit also includes a pulse shaping topology module; The pulse shaping topology network is composed of a half-bridge structure.

3. The pulse response dynamic impedance measurement and control device as described in claim 1, characterized in that, The control unit includes an embedded control unit and a logic control unit; The embedded control unit includes a microprocessor, and the logic control unit includes a programmable logic device.

4. The pulse response dynamic impedance measurement and control device as described in claim 1, characterized in that, It also includes a system power supply unit. The acquisition module includes a voltage acquisition unit, a current acquisition unit, and a dual-channel high-speed A / D module. The voltage acquisition unit includes a voltage divider unit, a signal conditioning unit, and a data measurement unit. The output voltage is supplied to the high-speed A / D module for acquisition through a resistor voltage divider, and the output current is converted into a voltage signal by a current sensor for acquisition by the high-speed A / D module.

5. A pulse-response dynamic impedance measurement and control method, said method being applied to the pulse-response dynamic impedance measurement and control device as described in any one of claims 1 to 4, characterized in that, include: The control unit sends control signals, including operating parameters, to the pulse generation unit; The pulse generation unit generates a low-voltage pulse, which is applied across the load. The acquisition module simultaneously measures the voltage and current across the load, detects the voltage and current, and converts the analog signals into digital signals. The control unit stores and transmits the acquired digital signals, and obtains the impedance value based on the voltage and current. Specifically, a nanosecond-level fast pulse is output to the electrode pins at both ends of the load before and after the high-voltage pulse is applied, respectively, to obtain the impedance information. The applied high-voltage pulse width and electrode needle depth are adjusted according to the impedance information; the nanosecond-level fast pulse is a low-voltage measurement square wave pulse with an adjustable pulse voltage amplitude of 10-100V and an adjustable pulse width of 5-100μs, while the pulse leading edge and trailing edge are both less than 50ns; the voltage field strength of the nanosecond-level fast pulse does not exceed 100V / cm.

6. The pulse-response dynamic impedance measurement and control method as described in claim 5, characterized in that, The interface unit feeds back the impedance value to the high-voltage pulse ablation device to provide feedback on the high-voltage pulse ablation results.

7. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores a computer program that, when executed by a processor, implements the steps of the impulse-response dynamic impedance measurement and control method as described in claim 5 or 6.

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