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CN-122005051-A - Method and apparatus for generating a composite pulsed electric field signal

CN122005051ACN 122005051 ACN122005051 ACN 122005051ACN-122005051-A

Abstract

A method and apparatus for generating a composite pulsed electric field signal includes generating, by a control module, a composite digital drive signal including microsecond and nanosecond sequential logic, and inverting, by a high-speed solid state switch matrix, a DC high voltage into a composite pulse waveform structurally including both microsecond and nanosecond sequential features in response to the composite digital drive signal. The device comprises a control module, a high-voltage direct-current power supply module and the high-speed solid-state switch matrix adopting a wide bandgap semiconductor device. According to the invention, by generating the composite pulse waveform with microsecond and nanosecond dual time sequence characteristics, the response frequency of nerve muscles is avoided by utilizing the high-frequency characteristic of the nanosecond characteristics, and the microsecond characteristics are ensured to provide enough ablation energy, so that the muscle contraction and pain in the treatment process are fundamentally inhibited, the operation safety and economy are improved, and the ablation efficiency is hopefully improved through a dual electroporation mechanism.

Inventors

  • ZHANG SHUNXIN
  • HU LILI
  • ZHAO QINGXIAO

Assignees

  • 上海诺生医疗科技有限公司

Dates

Publication Date
20260512
Application Date
20260407

Claims (10)

  1. 1. A method for generating a composite pulsed electric field signal comprising a control module and a high-speed solid state switching matrix; the control module generates a composite digital drive signal comprising microsecond sequential logic and nanosecond sequential logic; the high-speed solid-state switch matrix responds to the composite digital driving signal to invert direct-current high voltage into a composite pulse waveform which structurally comprises microsecond time sequence characteristics and nanosecond time sequence characteristics.
  2. 2. The method for generating a composite pulsed electric field signal of claim 1, wherein the composite pulse waveform comprises a microsecond pulse envelope from a plurality of high frequency nanosecond subpulses.
  3. 3. The method for generating a composite pulsed electric field signal of claim 1, wherein the composite pulse waveform comprises nanosecond pulse bursts and microsecond pulse trains that are alternately output in time.
  4. 4. The method for generating a composite pulsed electric field signal of claim 1, wherein the microsecond timing feature comprises a reference microsecond pulse and the composite pulse waveform comprises superimposing one or more nanosecond spikes on the reference microsecond pulse.
  5. 5. The method for generating a composite pulsed electric field signal of any one of claims 1-4, wherein the nanosecond timing feature has a pulse width of 1ns to 900ns; The duration of the microsecond-level timing feature is 1 μs to 500 μs; The working frequency of the nanosecond time sequence characteristic is 1MHz to 50MHz; the composite pulse waveform is biphasic.
  6. 6. The method for generating a composite pulsed electric field signal of claim 2, wherein the nanosecond-level sub-pulses comprise an intermittent period of 10ns to 900ns therebetween.
  7. 7. The method for generating a composite pulsed electric field signal of claim 4, wherein the nanosecond spikes comprise an intermittent period of 10ns to 900ns between them.
  8. 8. The pulsed electric field ablation equipment is characterized by comprising a control module, a high-voltage direct-current power supply module and a high-speed solid-state switch matrix; The control module is configured to generate a composite digital drive signal comprising microsecond sequential logic and nanosecond sequential logic; The high-speed solid-state switch matrix adopts a wide bandgap semiconductor device and is configured to receive the composite digital driving signal so as to invert the direct-current high voltage provided by the high-voltage direct-current power supply module into a composite pulse waveform which structurally comprises microsecond time sequence characteristics and nanosecond time sequence characteristics.
  9. 9. The pulsed electric field ablation device of claim 8, wherein the control module is configured to generate a composite digital drive signal selected from one of the following to produce a corresponding composite pulse waveform: A waveform comprising a microsecond pulse envelope formed by a plurality of high-frequency nanosecond subpulses; Waveform of alternately outputting nanosecond pulse group and microsecond pulse sequence in time, or Wherein the microsecond timing feature comprises a reference microsecond pulse and a waveform of one or more nanosecond spikes superimposed on the reference microsecond pulse.
  10. 10. The pulsed electric field ablation device of claim 8 or 9, wherein switch rise and fall times of the high-speed solid state switch matrix are no greater than 20ns; the output voltage range of the high-voltage direct-current power supply module is 500V to 5000V; The control module is configured to generate one or more sets of preset composite digital drive signals for treating an arrhythmia or tumor.

Description

Method and apparatus for generating a composite pulsed electric field signal Technical Field The invention relates to the technical field of medical instruments and biomedical engineering, in particular to a method and equipment for generating a composite pulse electric field signal. And more particularly to a pulse generation method and apparatus for pulsed electric field ablation (Pulsed Field Ablation, PFA). Background Pulsed electric field ablation (Pulsed Field Ablation, PFA) is a leading-edge biological tissue ablation technique that is based on the irreversible electroporation (IRE) principle by applying high-voltage electric pulses to target tissue to form permanent micro-pores in the cell membrane, thereby inducing apoptosis. Because the preparation has selectivity to specific tissues and basically does not generate thermal effect, the preparation has wide application prospect in the fields of arrhythmia (such as atrial fibrillation), tumor ablation and the like. However, the existing pulsed electric field ablation technology still has obvious defects. The mainstream scheme adopts microsecond pulse, and the pulse width range is exactly coincident with the excitation time constant of the motor nerves and skeletal muscles, so that severe muscle tonic contraction and intense pain sensation of a patient are inevitably caused in the treatment process. To address this problem, surgery must typically be performed under deep general anesthesia with the assistance of muscle relaxants, which not only increases the risk of surgery, extends the post-operative recovery time for the patient, but also increases the cost of the medical procedure. To circumvent muscle stimulation, there have been studies attempting to employ pure nanosecond pulses. The pulse width of nanosecond pulse is far smaller than the time required by nerve excitation, and the muscle contraction can be effectively avoided, but the energy transfer efficiency is lower, and extremely high voltage needs to be applied to achieve the ablation volume equivalent to microsecond pulse, so that extremely harsh requirements are provided for hardware design of a pulse generator and insulation performance of an ablation catheter, the risk of generating electric sparks and microbubbles in the treatment process is obviously increased, and the safety is influenced. Furthermore, some existing pulse generating devices, although possibly integrating both microsecond and nanosecond pulse generating units, generally exist as two independent, switchable modes of treatment, outputting either a pure microsecond pulse or a pure nanosecond pulse through a selector switch, and fail to combine the advantages of both pulses in a single, coordinated pulse waveform, thus failing to fundamentally address the contradiction between ablation efficiency and muscle stimulation. Disclosure of Invention Aiming at the defects in the prior art, the invention aims to provide a method and a system for generating microsecond-nanosecond composite pulse electric field ablation signals, and aims to solve the technical problem that the pulse electric field ablation technology in the prior art is difficult to ensure the efficient ablation effect and simultaneously effectively inhibit the neuromuscular stimulation effect in the treatment process. The method for generating the composite pulse electric field signal comprises a control module and a high-speed solid-state switch matrix; the control module generates a composite digital drive signal comprising microsecond sequential logic and nanosecond sequential logic; the high-speed solid-state switch matrix responds to the composite digital driving signal to invert direct-current high voltage into a composite pulse waveform which structurally comprises microsecond time sequence characteristics and nanosecond time sequence characteristics. Preferably, the composite pulse waveform comprises a microsecond pulse envelope formed by a plurality of high frequency nanosecond sub-pulses. Preferably, the composite pulse waveform comprises nanosecond pulse groups and microsecond pulse sequences alternately output in time. Preferably, the microsecond timing feature comprises a reference microsecond pulse and the composite pulse waveform comprises superimposing one or more nanosecond spikes on the reference microsecond pulse. Preferably, the pulse width of the nanosecond timing feature is 1ns to 900ns; The duration of the microsecond-level timing feature is 1 μs to 500 μs; The working frequency of the nanosecond time sequence characteristic is 1MHz to 50MHz; the composite pulse waveform is biphasic. Preferably, the nanosecond sub-pulses comprise an intermittent period of 10ns to 900 ns. Preferably, the nanosecond spike pulse comprises an intermittent period of 10ns to 900 ns. The invention provides pulse electric field ablation equipment, which comprises a control module, a high-voltage direct-current power supply module and a high-speed solid-state switch