CN114601551B - High-frequency irreversible electroporation treatment system - Google Patents
High-frequency irreversible electroporation treatment system Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00613—Irreversible electroporation
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- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
- A61B2018/00648—Sensing and controlling the application of energy with feedback, i.e. closed loop control using more than one sensed parameter
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00696—Controlled or regulated parameters
- A61B2018/00726—Duty cycle
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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- A61B2018/00696—Controlled or regulated parameters
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- A—HUMAN NECESSITIES
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00779—Power or energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
Abstract
The invention provides a high-frequency irreversible electroporation treatment system, and belongs to the technical field of ablation control. The treatment system comprises a plurality of pulse electrodes and a pulse generator, wherein the pulse generator comprises a pulse controller and a pulse output end; the pulse controller is connected with the energy storage unit and the discharge unit; the energy storage unit is connected to a high-voltage power supply through a charging element; the pulse controller is only communicated with the two pulse electrodes at the same time, and pulse electrical stimulation signals generated by the pulse generator are sequentially transmitted to the two pulse electrodes according to time; the pulse controller also controls communication of the pulse output end and the pulse electrode group or adjusts the pulse width of the pulse electrical stimulation signal based on the monitored residual capacity of the energy storage unit. The treatment of the invention can form interactive feedback with the target fusion area during treatment, and the fusion area is more uniform, and pulse abnormity caused by short-time repeated charge and discharge of the energy storage and discharge unit is avoided.
Description
Technical Field
The invention belongs to the technical field of ablation control, and particularly relates to a high-frequency irreversible electroporation treatment system.
Background
Irreversible Electroporation (IRE) is an emerging non-thermal ablation technique for treating tumors, which employs microsecond-level high-voltage electrical pulses to form nanopores in the cell membranes of affected cells, thereby changing the permeability of the cell membranes, disrupting the homeostasis of the cells, and further causing apoptosis, and this process is called Irreversible Electroporation. A typical treatment protocol for irreversible electroporation is to deliver a square wave pulse of 1500 v/cm voltage and 50-100 mus pulse width in a total dose of 70-100 pulses in one direction between two electrode needles. The number of electrodes, the distance between the electrodes and the exposed length of the electrodes can be adjusted according to the size and the shape of the tumor in the treatment process. When the IRE is used, most importantly, the electric field can not cause tissue damage caused by heating of the ear due to heat when the cell membrane is damaged, so that the IRE has wide application prospect in clinic, can perform minimally invasive ablation particularly on the focus close to important blood vessels and nerves, and improves the safety of treatment.
Although IRE has good clinical prospect, the existing irreversible electroporation adopts unipolar high-voltage pulse to act on cells, when the technique is used for irreversible ablation of tumor cells of a human body, the instant of pulse discharge can cause large twitch of muscles of the patient, induce large movement of limbs of the patient, and seriously affect the position fixation and treatment effect of a discharge electrode. Therefore, at present, the trachea intubation, general anesthesia, muscle relaxant injection and ventilator assistance are needed for the patient in the implementation of the operation, the operation cannot be conveniently performed under the local anesthesia as the most of the currently applied clinical interventional minimally invasive operations, the operation process is complicated, the cost is high, the complexity and the risk of the ablation operation are increased, and some complications may be caused, so the application and the popularization of the technology are limited.
By retrieval, most of the ablation controls of the prior art are symmetrical pulses. Although there are some asymmetric pulse control techniques proposed in the prior art, such as the irreversible electroporation ablation system disclosed in the chinese patent application publication No. CN112022331A, it is proposed to apply asymmetric pulses to the ablation electrode to make it output an electrical stimulation signal, and idle time is set for the process of switching from the asymmetric pulse positive pulse to the negative pulse and from the asymmetric pulse negative pulse to the positive pulse. However, in practical application, it is found that the above technical solution still adopts a monopolar electrode, and the idle time is 0.1-30us, so that the device needs frequent charging and discharging in high-voltage discharging, and a short charging and discharging process may cause pulse abnormality (e.g. saw stabs), so that uniformity and safety of the ablation region are affected, and real-time feedback with the state of the ablation region cannot be formed.
Disclosure of Invention
In order to solve the above technical problems, the present invention provides a high frequency irreversible electroporation therapy system, comprising a plurality of pulse electrodes and a pulse generator, wherein the pulse generator comprises a pulse controller and a pulse output end; the pulse controller is connected with the energy storage unit and the discharge unit; the energy storage unit is connected to a high-voltage power supply through a charging element; the pulse controller is only communicated with the two pulse electrodes at the same time, and pulse electrical stimulation signals generated by the pulse generator are sequentially transmitted to the two pulse electrodes according to time; the pulse controller also controls communication of the pulse output end and the pulse electrode group or adjusts the pulse width of the pulse electrical stimulation signal based on the monitored residual capacity of the energy storage unit.
Specifically, the technical scheme of the invention is realized as follows:
a high frequency irreversible electroporation therapy system, the therapy system comprising a plurality of pulse electrodes and a pulse generator.
Specifically, the plurality of pulse electrodes are composed of a plurality of pulse electrode groups, and each pulse electrode group is composed of two pulse electrodes.
The pulse generator comprises a pulse controller and a pulse output end;
the pulse output end is connected with one of the pulse electrode groups through a gating device;
the pulse controller is connected with the energy storage unit and the discharge unit;
the energy storage unit is connected to a high-voltage power supply through a charging element;
the pulse controller is simultaneously communicated with two pulse electrodes in one pulse electrode group at the same time, and pulse electrical stimulation signals generated by the pulse generator are sequentially transmitted to the two pulse electrodes according to time.
Specifically, the pulse controller controls the pulse output end to control the pulse output end to only communicate with one group of pulse electrodes at the same time through the gating device.
As a further improvement technical means, the two pulse electrodes comprise a first positive phase pulse electrode and a second negative phase pulse electrode;
the pulse controller controls the pulse output end to be communicated with the first positive phase pulse electrode and the second negative phase pulse electrode at a first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the first positive phase pulse electrode at the first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the second negative phase pulse electrode at a second moment, wherein the first moment is different from the second moment.
Structurally, the first positive phase pulse electrode directly receives the pulse electrical stimulation signal generated by the pulse generator and acts on an ablation area;
and the second reverse-phase pulse electrode receives the pulse electrical stimulation signal generated by the pulse generator, performs reverse-phase processing on the pulse electrical stimulation signal and acts on the ablation area.
In a specific treatment, the first control mode of the high-frequency irreversible electroporation treatment system is as follows:
the pulse controller monitors the residual capacity of the energy storage unit;
when the residual capacity of the energy storage unit is lower than a first preset value, the pulse controller controls the pulse output end to disconnect the communication with the pulse electrode group which is currently communicated, and controls the pulse output end to communicate with another pulse electrode group after waiting for a preset time period.
In a specific treatment, the second control mode of the high-frequency irreversible electroporation treatment system is as follows:
the pulse controller monitors the current residual capacity of the energy storage unit;
and when the residual capacity of the energy storage unit is larger than a first preset value, the pulse width of the pulse electrical stimulation signal generated by the pulse generator is adjusted based on the current residual capacity of the energy storage unit.
In a specific treatment, the third control mode of the high-frequency irreversible electroporation treatment system is as follows:
each pulse electrode is coupled with an optical fiber temperature sensor;
when the pulse electrode receives the pulse electrical stimulation signal, the optical fiber temperature sensor is started to monitor the temperature of an ablation area in real time;
when the temperature exceeds a set temperature threshold value, generating a feedback signal and sending the feedback signal to the pulse controller;
the pulse controller adjusts the pulse width and the duty ratio of the current pulse electrical stimulation signal based on the feedback signal.
As a further introduction of a hardware structure, the pulse generator is connected with an upper computer, a high-speed switch controller and a lower computer;
the upper computer is provided with an output pulse form, and the lower computer transmits an electrical stimulation signal generated by the pulse generator to the high-speed switch controller through optical isolation;
the high-speed switch controller controls the high-speed switch to be switched on and off, and a bridge circuit formed by the high-speed switch forms unipolar or bipolar output pulses.
The system further comprises a foot pedal that defaults to a non-activated state;
the pulse controller monitors whether the discharge current output by the discharge unit meets a preset condition in real time;
and when the discharge current meets a preset condition, activating the foot switch.
In order to better embody the uniformity, each pulse electrode comprises a branch lobe and a branch electrode.
The therapy of the invention can form interactive feedback with a target fusion area during therapy, and the fusion area is more uniform, and pulse abnormity caused by short-time repeated charging and discharging of the energy storage and discharge unit is avoided.
According to the technical scheme, the upper computer is provided with an output pulse form, instructions are sent to the lower computer, the lower computer is transmitted to the high-speed switch controller through optical isolation, the controller controls the switch to be switched on and off, and unipolar or bipolar output pulses are formed through a bridge circuit formed by the high-speed switch. The pulse width can be accurately adjusted according to the temperature feedback signal of the ablation electrode, and zero-heat-loss high-voltage steep pulse ablation is realized.
In the technical scheme of the invention, the optical fiber temperature sensor coupled in the electrode monitors the temperature in the feedback ablation process in real time, and when the temperature exceeds the set threshold temperature, the pulse width and the duty ratio are adjusted to realize zero heat loss ablation in an ablation area.
According to the technical scheme, alternating current can be converted into direct current through the local thermal ablation module through the switching power supply, the direct current is converted into high-frequency alternating current, and the high-frequency alternating current is output to the outside; a temperature sensor coupled in the ablation electrode monitors the temperature of the feedback ablation electrode in real time; the control module receives the feedback signal, controls the voltage amplitude after conversion, dynamically adjusts the output power and accurately controls the range of the thermal field.
According to the technical scheme, when the residual capacity of the energy storage unit is lower than a first preset value, the pulse controller controls the pulse output end to disconnect the communication with the pulse electrode group which is currently communicated, and controls the pulse output end to communicate with another pulse electrode group after waiting for a preset time period, so that the ablation area is more uniform, and pulse abnormity caused by short-time repeated charging and discharging of the energy storage and discharge unit is avoided.
Further advantages of the invention will be apparent from the detailed description of embodiments which follows, when considered in conjunction with the accompanying drawings.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.
Fig. 1 is a schematic diagram of a basic architecture of a high-frequency irreversible electroporation therapy system according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of the basic architecture of a high frequency irreversible electroporation therapy system according to yet another preferred embodiment of the present invention;
FIG. 3 is a first control flow diagram illustrating the treatment principle of the high frequency irreversible electroporation treatment system shown in FIG. 1;
FIG. 4 is a schematic diagram of a second control flow of the treatment principle of the high-frequency irreversible electroporation treatment system shown in FIG. 1;
fig. 5 is a schematic layout of branch lobes and branch electrodes employed in the high-frequency irreversible electroporation therapy system of fig. 1.
Detailed Description
The invention is further described with reference to the following drawings and detailed description.
Referring to fig. 1, fig. 1 is a schematic diagram of a basic architecture of a high frequency irreversible electroporation therapy system according to an embodiment of the present invention.
In fig. 1, the treatment system comprises a plurality of pulse electrodes and a pulse generator, the pulse generator comprises a pulse controller and a pulse output end; the pulse output end can be connected with the plurality of pulse electrodes; the pulse controller is connected with the energy storage unit and the discharge unit; the energy storage unit is connected to a high-voltage power supply through a charging element; the pulse controller is simultaneously communicated with the two pulse electrodes at the same time, and the pulse electrical stimulation signals generated by the pulse generator are successively transmitted to the two pulse electrodes according to time.
In a specific structure, the plurality of pulse electrodes comprise a plurality of groups of pulse electrodes; each group of pulse electrodes consists of two pulse electrodes; the pulse controller communicates with two pulse electrodes simultaneously at the same time, specifically includes: the pulse controller controls the pulse output end to be communicated with only one group of pulse electrodes at the same time.
More specifically, the two pulse electrodes in each set of pulse electrodes include a first positive phase pulse electrode (solid line in fig. 1) and a second negative phase pulse electrode (dotted line in fig. 1).
As a specific embodiment, the pulse output end is connected with one of the plurality of pulse electrode groups through a gate;
specifically, the pulse controller controls the pulse output end to control the pulse output end to only communicate with one group of pulse electrodes at the same time through the gating device.
The pulse controller controls the pulse output end to be communicated with the first positive phase pulse electrode and the second negative phase pulse electrode at a first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the first positive phase pulse electrode at the first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the second negative phase pulse electrode at a second moment, wherein the first moment is different from the second moment.
Structurally, the first positive phase pulse electrode directly receives a pulse electrical stimulation signal generated by the pulse generator and acts on an ablation area;
and the second reverse-phase pulse electrode receives the pulse electrical stimulation signal generated by the pulse generator, performs reverse-phase processing on the pulse electrical stimulation signal and acts on the ablation area.
As a further principle example, on the basis of fig. 1, see fig. 2.
In fig. 2, the pulse generator is connected to an upper computer, a high-speed switch controller and a lower computer;
the upper computer is provided with an output pulse form, and the lower computer transmits an electrical stimulation signal generated by the pulse generator to the high-speed switch controller through optical isolation;
the high-speed switch controller controls the high-speed switch to be switched on and off, and a bridge circuit formed by the high-speed switch forms unipolar or bipolar output pulses.
The system further comprises a foot pedal, the foot pedal defaulted to an inactive state;
the pulse controller monitors whether the discharge current output by the discharge unit meets a preset condition in real time;
and when the discharge current meets a preset condition, activating the foot switch.
By way of principle introduction, the high-frequency irreversible electroporation therapy system comprises three units, namely high-voltage steep pulse ablation, real-time temperature monitoring feedback and local thermal ablation, as general module units.
High-voltage steep pulse ablation: high-voltage direct-current ultra-narrow pulses are released between the electrodes, and large current is formed between the electrodes, so that the tumor cells between the electrodes generate irreversible electroporation and enter apoptosis. The module accurately samples the temperature of the ablation electrode through the optical fiber temperature sensor coupled with the inside of the ablation electrode, dynamically adjusts the pulse width and realizes irreversible electroporation ablation without heat loss.
Local thermal ablation: the optical fiber temperature sensor is coupled in the ablation electrode, the change of the temperature causes the change of the laser wavelength, the reflected light is connected to the spectrometer integrated in the host through the coupling interface, the spectrum change is identified and converted into a temperature signal, the temperature signal is fed back to the local heat ablation control module, and the output power of the alternating voltage between the electrodes is dynamically adjusted. The local heat ablation adopts the high-frequency alternating current released between a single electrode and a leg polar plate, the local heat ablation is completed by taking the electrode as the center, the output power is accurately adjusted through an accurate optical fiber temperature sensor, the ablation range is accurately controlled, the tumor microenvironment is destroyed, the local drug delivery concentration is enhanced, and the drug curative effect is improved.
Specifically, the high-voltage steep pulse generating device charges the energy storage element through the high-voltage power supply, and the control circuit controls the quick switching element to form high-voltage ultra-narrow pulses.
And the optical fiber temperature sensor coupled in the electrode monitors the temperature in the feedback ablation process in real time, and when the temperature exceeds a set threshold temperature, the pulse width and the duty ratio are adjusted to realize zero heat loss ablation in an ablation region.
The local thermal ablation module converts alternating current into direct current through a switching power supply, and the direct current is converted into high-frequency alternating current and is output to the outside; a temperature sensor coupled in the ablation electrode monitors the temperature of the feedback ablation electrode in real time; the control module receives the feedback signal, controls the voltage amplitude after conversion, dynamically adjusts the output power and accurately controls the range of the thermal field.
High-voltage steep pulse: the upper computer is provided with an output pulse form, instructions are sent to the lower computer, the lower computer is conveyed to the high-speed switch controller through optical isolation, the controller controls the switch to be switched on and off, and unipolar or bipolar output pulses are formed through a bridge circuit formed by the high-speed switch. The pulse width can be accurately adjusted according to the temperature feedback signal of the ablation electrode, and zero-heat-loss high-voltage steep pulse ablation is realized.
The FBG is coupled with the ablation electrode, when the temperature of the electrode changes, the temperature of the sensor part is driven to change, the thermal expansion effect and the thermo-optic effect of the optical fiber cause the wavelength drift of the reflection center of the Bragg grating, and the temperature is in direct proportion to the wavelength drift. The spectrum of the reflected light is changed, the reflected light is fed back to the spectrometer through the optical fiber and is converted into temperature change, the temperature change is converted into control quantity, and the control quantity is sent to the high-voltage steep pulse control module and the heat ablation module.
And the local thermal ablation control unit is used for transmitting a signal to the power amplification circuit and controlling the unit power regulation circuit.
Further, the control unit outputs a drive signal that controls the power amplifier to output a high-frequency alternating signal.
Further, the power regulating circuit is used for regulating the supply voltage of the power amplifying circuit.
Further, the power regulating circuit is a buck conversion circuit.
Further, the power amplifying circuit is also used for receiving a radio frequency driving signal.
Further, the power amplification circuit includes: a MOSFET drive circuit for generating a pair of complementary drive signals; the pair of MOSFETs in push-pull operation is connected with the MOSFET driving circuit and used for carrying out push-pull amplification on the radio frequency signals according to the complementary driving signals; and the isolation output transformer is connected with the push-pull working MOSFET and is used for isolating and transforming the radio-frequency signal amplified by the push-pull.
Further, the output of the temperature detection module is connected with a control circuit, and is used for sending the operation parameters of the feedback control power amplification circuit to the control circuit.
Based on the hardware configuration of fig. 1 or fig. 2, fig. 3 to fig. 4 show several control modes of the high-frequency irreversible electroporation therapy system according to the present invention:
as a control means, see fig. 3.
When the pulse generator starts to work, the pulse controller controls the pulse output end to be communicated with the first positive phase pulse electrode and the second negative phase pulse electrode at a first moment, and transmits a pulse electrical stimulation signal generated by the pulse generator to the first positive phase pulse electrode at the first moment;
then, after waiting for an adjustable first preset time, the pulsed electrical stimulation signal generated by the pulse generator is transmitted to the second antiphase pulse electrode at a second time, wherein the first time is different from the second time.
Next, the pulse controller monitors the remaining capacity of the energy storage unit;
when the residual capacity of the energy storage unit is lower than a first preset value, the pulse controller controls the pulse output end to disconnect the communication with the pulse electrode group which is currently communicated, controls the pulse output end to communicate with another pulse electrode group after waiting for an adjustable second preset time, and then continues to return to the step at the beginning.
The "adjustable preset time" here can be increased appropriately with reference to the prior art, for example, on the basis of the idle time disclosed in the prior art mentioned in the background, which is not specifically developed by the present invention.
As another control method, see fig. 4.
At the beginning, the pulse controller controls the pulse output end to communicate with the first positive phase pulse electrode and the second negative phase pulse electrode at a first moment, and transmits a pulse electrical stimulation signal generated by the pulse generator to the first positive phase pulse electrode at the first moment;
then, after waiting for an adjustable first preset time, the pulsed electrical stimulation signal generated by the pulse generator is transmitted to the second antiphase pulse electrode at a second time, wherein the first time is different from the second time.
Next, the pulse controller monitors the remaining capacity of the energy storage unit;
the pulse controller monitors the current residual capacity of the energy storage unit;
and when the residual capacity of the energy storage unit is larger than a first preset value, the pulse width of the pulse electrical stimulation signal generated by the pulse generator is adjusted based on the current residual capacity of the energy storage unit.
As a specific example, the remaining capacity of the energy storage unit may be measured by a remaining ratio, and the pulse width of the pulsed electrical stimulation signal generated by the pulse generator may be adjusted by using the following formula based on the current remaining capacity of the energy storage unit:
wherein PlusW is the adjusted pulse width; plus is the pulse width before adjustment, sum is the total capacity of the energy storage unit, SUMr is the residual capacity of the energy storage unit, and the two are measured by the same unit. The value of Sum is greater than 1.
Pulse width modulation techniques are also referred to in the art.
As still another control method, although not shown, the present embodiment includes:
each pulse electrode is coupled with an optical fiber temperature sensor;
when the pulse electrode receives the pulse electrical stimulation signal, the optical fiber temperature sensor is started to monitor the temperature of an ablation area in real time;
when the temperature exceeds a set temperature threshold value, generating a feedback signal and sending the feedback signal to the pulse controller;
the pulse controller adjusts the pulse width and the duty ratio of the current pulse electrical stimulation signal based on the feedback signal.
Based on the above embodiment, the optical fiber temperature sensor coupled in the electrode monitors the temperature in the feedback ablation process in real time, and when the temperature exceeds the set threshold temperature, the pulse width and the duty ratio are adjusted to realize the zero-heat-loss ablation in the ablation region.
Therefore, interactive feedback can be formed between the target fusion area and the target fusion area during treatment, the fusion area is more uniform, and pulse abnormity caused by short-time repeated charging and discharging of the energy storage and discharge unit is avoided.
To further improve the non-uniformity, in various embodiments of the present invention, each of the pulse electrodes comprises a branch lobe and a branch electrode, see fig. 5.
Referring to fig. 5, an electrode arrangement form of the branch electrode lobes is given by taking a 4-electrode group as an example.
In one embodiment, the electrodes comprise 2-8 branch petals, 3-8 electrodes are attached to the branch electrode petals, each electrode can be independently addressed, the electrodes can be used as stimulation electrodes to generate stimulation signals and release ablation pulse voltage, the electrode insulating tube and the guide wire have insulating characteristics, and corresponding insulating materials are not broken under the action of pulse voltage of at least 2000V and pulse width of 100 us. The catheter comprises 4-8 electrode lobes, and can be opened to form a lantern shape or tightened to form a column shape under the pulling or pushing action of the traction tube. After the electrode is contracted, the diameter of the catheter is 4-10mm, and after the electrode is opened, the diameter of the front end is 10-40mm.
The electrode arrangement form can be arranged according to the conditions of the number of branch petals, the number of electrodes of each branch petal, the electrode distance, the electrode length, the electrode diameter, the petal opening circumference diameter, the electrode section shape and the like, and meanwhile, the electrode material also has different choices.
The electrodes on the independent branch lobes discharge pairwise, and each branch lobe is used as a discharge side branch to form a discharge side branch so as to form linear ablation.
It should be noted that the present invention can solve a plurality of technical problems or achieve corresponding technical effects, but does not require that each embodiment of the present invention solves all the technical problems or achieves all the technical effects, and an embodiment that separately solves one or several technical problems or achieves one or more improved effects also constitutes a separate technical solution.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the same, and although the present invention is described in detail with reference to the above embodiments, those of ordinary skill in the art should understand that: modifications and equivalents may be made to the embodiments of the invention without departing from the spirit and scope of the invention, which is to be covered by the claims.
Claims (8)
1. A high frequency irreversible electroporation therapy system, the therapy system comprising a plurality of pulse electrodes and a pulse generator, the system comprising:
the pulse generator comprises a pulse controller and a pulse output end;
the pulse output end is in gating connection with the plurality of pulse electrodes;
the pulse controller is connected with the energy storage unit and the discharge unit;
the energy storage unit is connected to a high-voltage power supply through a charging element;
the pulse controller is simultaneously communicated with two pulse electrodes at the same time, and the two pulse electrodes comprise a first positive phase pulse electrode and a second negative phase pulse electrode;
the pulse controller controls the pulse output end to be communicated with the first positive phase pulse electrode and the second negative phase pulse electrode at a first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the first positive phase pulse electrode at the first moment and transmits the pulse electrical stimulation signal generated by the pulse generator to the second negative phase pulse electrode at a second moment, wherein the first moment is different from the second moment;
the pulse controller monitors the current residual capacity of the energy storage unit;
when the residual ratio of the capacity of the energy storage unit is greater than a first preset value, the pulse width of the pulse electrical stimulation signal generated by the pulse generator is adjusted as follows:
wherein, the ratio is a percentage value between 0 and 1; plusW is the adjusted pulse width; plus is the pulse width before adjustment, sum is the total capacity of the energy storage unit, and SUMr is the residual capacity of the energy storage unit.
2. The high frequency irreversible electroporation therapy system of claim 1, wherein:
the plurality of pulse electrodes comprises a plurality of groups of pulse electrodes;
each group of pulse electrodes consists of two pulse electrodes;
the pulse controller communicates with two pulse electrodes simultaneously at the same time, specifically includes:
the pulse controller controls the pulse output end to be communicated with only one group of pulse electrodes at the same time.
3. The high frequency irreversible electroporation therapy system of claim 1, wherein:
the pulse controller monitors the residual capacity of the energy storage unit;
when the residual capacity of the energy storage unit is lower than a first preset value, the pulse controller controls the pulse output end to disconnect the communication between the pulse output end and the currently communicated pulse electrode group, and controls the pulse output end to communicate with another group of pulse electrode groups after waiting for a preset time period.
4. The high frequency irreversible electroporation therapy system of claim 1, wherein:
each pulse electrode is coupled with an optical fiber temperature sensor;
when the pulse electrode receives the pulse electrical stimulation signal, the optical fiber temperature sensor is started to monitor the temperature of an ablation area in real time;
when the temperature exceeds a set temperature threshold value, generating a feedback signal and sending the feedback signal to the pulse controller;
the pulse controller adjusts the pulse width and the duty ratio of the current pulse electrical stimulation signal based on the feedback signal.
5. The high frequency irreversible electroporation therapy system of claim 1, wherein:
the pulse generator is connected with the upper computer, the high-speed switch controller and the lower computer;
the upper computer is provided with an output pulse form, and the lower computer transmits an electrical stimulation signal generated by the pulse generator to the high-speed switch controller through optical isolation;
the high-speed switch controller controls the high-speed switch to be switched on and off, and a bridge circuit formed by the high-speed switch forms unipolar or bipolar output pulses.
6. The high frequency irreversible electroporation therapy system of claim 1, wherein:
the system further comprises a foot pedal that defaults to a non-activated state;
the pulse controller monitors whether the discharge current output by the discharge unit meets a preset condition in real time;
and when the discharge current meets a preset condition, activating the foot switch.
7. The high frequency irreversible electroporation therapy system of claim 1, wherein:
the first positive phase pulse electrode directly receives the pulse electrical stimulation signal generated by the pulse generator and acts on an ablation area;
and the second reverse-phase pulse electrode receives the pulse electrical stimulation signal generated by the pulse generator, performs reverse-phase processing on the pulse electrical stimulation signal and acts on the ablation area.
8. The high frequency irreversible electroporation therapy system of claim 1, wherein:
each pulse electrode comprises a branch lobe and a branch electrode.
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