CN114469310A - Electrode control system for irreversible electroporation equipment - Google Patents
Electrode control system for irreversible electroporation equipment Download PDFInfo
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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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- 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
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
- A61B2018/00375—Ostium, e.g. ostium of pulmonary vein or artery
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- A—HUMAN NECESSITIES
- 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
- 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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- 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
- 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
- A61B2018/00666—Sensing and controlling the application of energy using a threshold value
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- A—HUMAN NECESSITIES
- 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
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00696—Controlled or regulated parameters
- A61B2018/00726—Duty cycle
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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
- A61B2018/00696—Controlled or regulated parameters
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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
- A61B2018/00797—Temperature measured by multiple temperature sensors
Abstract
The invention provides an electrode control system for irreversible electroporation equipment, and belongs to the technical field of ablation control. The pulse generator sequentially transmits pulse electrical stimulation signals to a first positive phase pulse main electrode and a second negative phase pulse main electrode of a group of pulse electrodes according to time; when the absolute value of the difference value between the first temperature detected by the first optical fiber temperature sensor and the second temperature detected by the second optical fiber temperature sensor is greater than a preset value, generating a feedback signal and sending the feedback signal to the electrode control system; the electrode control system adjusts the pulse width and duty cycle of the pulsed electrical stimulation signal generated by the pulse generator based on the feedback signal. The first positive phase pulse main electrode and the second negative phase pulse main electrode respectively comprise a plurality of branch lobes, and each branch lobe is composed of a plurality of branch electrodes. The invention can improve the uniformity of ablation treatment and improve the safety and stability.
Description
Technical Field
The invention belongs to the technical field of ablation control, and particularly relates to an electrode control system for irreversible electroporation equipment.
Background
Atrial Fibrillation (AF) is a common cardiac arrhythmia. Currently, AF therapy is mainly drug and catheter ablation. Ablation is a treatment scheme in which pulmonary veins and local tissues are coagulated and necrosed in a heating or cooling mode, so that the pulmonary veins are isolated to stop AF treatment, and catheter ablation is the first-line treatment scheme of AF treatment. The pulse field ablation is a new ablation mode, the tissue is not subjected to coagulative necrosis in a refrigeration or heating mode, but high-voltage direct current pulses are released between electrodes to form a large number of hydrophilic nanoscale membrane-permeable holes on a cell membrane, so that the permeability of cells is increased, the cells are subjected to apoptosis, a high stop band is formed at the vestibule part of the pulmonary vein, abnormal pacing signals are blocked from being transmitted into the heart, and the purpose of treating atrial fibrillation is achieved.
Irreversible Electroporation (IRE) means that high-voltage ultrashort electric field pulses are applied between electrodes to act on a phospholipid bilayer of a cell membrane to generate a nanometer-scale unrecoverable cavity, so that the balance in the cell is destroyed, the cell is rapidly apoptotic, and the purpose of ablating cells with membrane structures is achieved. The generation of irreversible electroporation requires that ablation potential reaches a certain threshold value, and different membrane structure cell electroporation threshold values are different, so that the gradient characteristic can be utilized to realize specific ablation on the tissue with the membrane structure in an ablation region, but the tissue which does not reach the ablation threshold value can be healed, and the tissue which reaches the threshold value generates irreversible electroporation, so that apoptosis necrosis is generated.
The electrode is pushed to the target tissue through the catheter, and the electrode is conformally unfolded to a shape fitting the tissue or the vessel according to the structural characteristics, so that ablation treatment, such as treatment, is carried out on the tissue or the vessel: atrial fibrillation, refractory hypertension, hypertrophic cardiomyopathy.
By retrieval, most of the ablation controls of the prior art are symmetrical pulses. Although there are also some asymmetric pulse control techniques proposed in the prior art, such as the irreversible electroporation ablation system disclosed in the chinese patent application with publication number CN112022331A, it is proposed to apply asymmetric pulses to the ablation electrode to make it output electrical stimulation signals, and the idle time is set for the process of switching from the asymmetric pulse positive pulse to the negative pulse and from the negative pulse to the positive pulse.
However, in practical application, it is found that the above technical solution still adopts a single (pole) 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, which comprises a plurality of pulse electrodes and a pulse generator.
The pulse generator sequentially transmits pulse electrical stimulation signals to a first positive phase pulse main electrode and a second negative phase pulse main electrode of a group of pulse electrodes according to time; when the absolute value of the difference value between the first temperature detected by the first optical fiber temperature sensor and the second temperature detected by the second optical fiber temperature sensor is greater than a preset value, generating a feedback signal and sending the feedback signal to the electrode control system; the electrode control system adjusts the pulse width and duty cycle of the pulsed electrical stimulation signal generated by the pulse generator based on the feedback signal. The first positive phase pulse main electrode and the second negative phase pulse main electrode respectively comprise a plurality of branch lobes, and each branch lobe is composed of a plurality of branch electrodes.
The invention can improve the uniformity of ablation treatment and improve the safety and stability.
Specifically, the technical scheme of the invention is realized as follows:
an electrode control system for a non-reversible electroporation device, the electrode control system connected to the non-reversible electroporation device, the non-reversible electroporation device comprising a plurality of sets of pulse electrodes and a pulse generator;
the pulse generator is connected with the pulse output end, the energy storage unit and the discharge unit;
each group of pulse electrodes comprises a first positive phase pulse main electrode and a second reverse phase pulse main electrode;
the first positive phase pulse main electrode and the second negative phase pulse main electrode respectively comprise a plurality of branch lobes, and each branch lobe consists of a plurality of branch electrodes;
the pulse generator sequentially transmits the generated pulse electrical stimulation signals to the first positive phase pulse main electrode and the second negative phase pulse main electrode of the group of pulse electrodes according to time;
the first positive phase pulse main electrode is coupled with a first optical fiber temperature sensor, and the second negative phase pulse main electrodes are coupled with a second optical fiber temperature sensor;
when the absolute value of the difference value between the first temperature detected by the first optical fiber temperature sensor and the second temperature detected by the second optical fiber temperature sensor is greater than a preset value, generating a feedback signal and sending the feedback signal to the electrode control system;
and the electrode control system adjusts the pulse width and the duty ratio of the pulse electric stimulation signal generated by the pulse generator based on the feedback signal.
Further, the pulse output end is connected with one group of pulse electrodes in the multiple groups of pulse electrodes through a gating device;
the electrode control system 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 electrode control system 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 group of pulse electrodes after waiting for a preset time period.
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.
The pulse generator is communicated with only a first positive phase pulse main electrode and a second negative phase pulse main electrode in a group of pulse electrodes at the same time through the pulse output end;
the pulse generator sequentially transmits the generated pulse electrical stimulation signals to the first positive phase pulse main electrode and the second negative phase pulse main electrode of the group of pulse electrodes according to time, and the pulse generator specifically comprises:
the electrode control system controls the pulse output end to be communicated with the first positive phase pulse main electrode and the second negative phase pulse main electrode at a first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the first positive phase pulse main electrode at the first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the second negative phase pulse main electrode at a second moment, wherein the first moment is different from the second moment.
Further, the first positive phase pulse main electrode and the second negative phase pulse main electrode each include a plurality of branch lobes, each branch lobe is composed of a plurality of branch electrodes, and the specific details are as follows:
the sectional area of the branch electrodes on each branch valve is the same, and the arrangement mode of the branch electrodes on each branch valve adopts one of the following modes or any combination thereof:
a) the arrangement is carried out in the form of equal spacing and unequal spacing;
b) the equal length and unequal length are adopted for arrangement;
c) arranged in equal and unequal numbers.
Wherein, the electrodes on different branch valves discharge pairwise, and each branch valve is used as a discharge side branch to form linear ablation.
The electrodes on the same branch valve discharge pairwise to form annular ablation or orange valve-shaped ablation.
Numbering all the branch electrodes by continuous numerical values;
the odd-numbered branch electrodes are of the same positive polarity, the even-numbered branch electrodes are of the same negative polarity, and the branch electrodes discharge simultaneously to form rapid annular ablation.
The first positive phase pulse main electrode directly receives the pulse electrical stimulation signal generated by the pulse generator and distributes the pulse electrical stimulation signal to the branch electrodes of the branch valve to act on the ablation region;
and the second reverse pulse main electrode receives the pulse electrical stimulation signal generated by the pulse generator, performs reverse processing on the pulse electrical stimulation signal, and distributes the pulse electrical stimulation signal to the branch electrodes of the branch valve to act on the ablation region.
Based on the above framework, the electrode control system of the present invention controls the irreversible electroporation device to couple the ablation pulse with the cardiac stimulation signal.
Further advantages of the invention will be apparent in the detailed description section in conjunction with the drawings attached hereto.
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 the basic architecture of an electrode control system for an irreversible electroporation device according to an embodiment of the present invention;
FIG. 2 is a schematic control flow diagram of the electrode control system for the irreversible electroporation apparatus shown in FIG. 1;
FIG. 3 is a first control flow diagram illustrating the control principle of the electrode control system for the irreversible electroporation apparatus shown in FIG. 1;
FIG. 4 is a second control flow diagram illustrating the control principles of the electrode control system for the irreversible electroporation apparatus shown in FIG. 1;
FIG. 5 is a schematic view of the arrangement of branch petals and branch electrodes employed in the irreversible electroporation apparatus of the present invention;
fig. 6-11 are schematic diagrams illustrating the effect of the different combination schemes of the branch petals and the branch electrodes shown in fig. 5.
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 an electrode control system for an irreversible electroporation apparatus according to an embodiment of the present invention.
In fig. 1, the electrode control system is shown connected to a non-reversible electroporation device comprising a plurality of sets of pulse electrodes and pulse generators;
the pulse generator is connected with the pulse output end, the energy storage unit and the discharge unit;
each group of pulse electrodes comprises a first positive phase pulse main electrode and a second reverse phase pulse main electrode;
the first positive phase pulse main electrode and the second negative phase pulse main electrode respectively comprise a plurality of branch lobes, and each branch lobe consists of a plurality of branch electrodes;
the pulse generator transmits the generated pulse electrical stimulation signals to the first positive-phase pulse main electrode and the second negative-phase pulse main electrode of the group of pulse electrodes in sequence according to time;
in fig. 1, the pulse output terminal is connected to one of the pulse electrodes in the plurality of sets of pulse electrodes through a gate.
Based on fig. 1, referring to fig. 2, fig. 2 is a control flow diagram of the electrode control system for the irreversible electroporation apparatus shown in fig. 1.
In fig. 2, the first positive pulse main electrode is coupled with a first optical fiber temperature sensor, and the second negative pulse main electrodes are both coupled with a second optical fiber temperature sensor;
when the absolute value of the difference value between the first temperature detected by the first optical fiber temperature sensor and the second temperature detected by the second optical fiber temperature sensor is greater than a preset value, generating a feedback signal and sending the feedback signal to the electrode control system;
and the electrode control system adjusts the pulse width and the duty ratio of the pulse electric stimulation signal generated by the pulse generator based on the feedback signal.
As a more specific embodiment, the FBG can be coupled to 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 local heat ablation module.
High-voltage steep pulse ablation: high-voltage direct-current ultra-narrow pulses are released between the electrodes, and high 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 in the coupling and ablation electrode, dynamically adjusts the pulse width, and realizes non-heat-loss irreversible electroporation ablation.
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.
After the electrode control system adjusts the pulse width and the duty ratio of the pulse electrical stimulation signals generated by the pulse generator based on the feedback signals, the pulse generator sequentially transmits the generated pulse electrical stimulation signals to the first positive phase pulse main electrode and the second negative phase pulse main electrode of the group of pulse electrodes according to time.
Reference is next made to fig. 3 and 4.
FIG. 3 is a first control flow diagram illustrating the control principle of the electrode control system for the irreversible electroporation apparatus shown in FIG. 1;
in fig. 3, first, the pulse output terminal is connected to one of the pulse electrodes through a gate;
then, the electrode control system 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 electrode control system 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 group of pulse electrodes after waiting for a preset time period;
at this point, the start step (first step) may be returned.
In fig. 4, the control flow starts with: the pulse output end is connected with one group of pulse electrodes in the multiple groups of pulse electrodes through a gating device;
then, the electrode control system monitors the residual capacity of the energy storage unit;
when the residual capacity of the energy storage unit is larger than a first preset value, the pulse width of a pulse electrical stimulation signal generated by the pulse generator is adjusted based on the current residual capacity of the energy storage unit;
at this time, the strobe signal is not changed, and the control starting process is continued.
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.
In the above embodiment, the pulse generator communicates with only the first positive phase pulse main electrode and the second negative phase pulse main electrode in one group of pulse electrodes through the pulse output terminal at the same time;
the pulse generator sequentially transmits the generated pulse electrical stimulation signals to the first positive phase pulse main electrode and the second negative phase pulse main electrode of the group of pulse electrodes according to time, and the pulse generator specifically comprises:
the electrode control system controls the pulse output end to be communicated with the first positive phase pulse main electrode and the second negative phase pulse main electrode at a first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the first positive phase pulse main electrode at the first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the second negative phase pulse main electrode at a second moment, wherein the first moment is different from the second moment.
Obviously, the second time is a time that is delayed by a preset time period from the first time.
The delay can avoid frequent charge and discharge in short time and ensure the continuity of treatment, thereby improving the safety and stability.
Meanwhile, in the above embodiment, the first positive phase pulse main electrode directly receives the pulsed electrical stimulation signal generated by the pulse generator and distributed to the branch electrodes of the branch valve to act on the ablation region;
and the second reverse pulse main electrode receives the pulse electrical stimulation signal generated by the pulse generator, performs reverse processing on the pulse electrical stimulation signal, and distributes the pulse electrical stimulation signal to the branch electrodes of the branch valve to act on the ablation region.
Compared with the unipolarity, the uniformity effect can be improved; meanwhile, compared with the prior art that asymmetric pulses are respectively applied by adopting single polarity, the improved mode does not need to adjust the pulses generated by the pulse generator, so that the response is quicker, and idle time does not need to be waited.
On the basis of fig. 1 to 4, in order to further enhance the uniformity, referring to fig. 5, the first positive phase pulse main electrode and the second negative phase pulse main electrode each include a plurality of branch lobes, and each branch lobe is composed of a plurality of branch electrodes. Fig. 5 is a schematic diagram showing the layout of branch petals and branch electrodes employed in the irreversible electroporation apparatus of the present invention.
In fig. 5, the electrodes include 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 down under the action of pulse voltage of at least 2000V and pulse width of 100 us. The catheter comprises 4-8 electrode petals, and can be opened to be in a lantern shape or tightened to be in a column shape under the pulling or pushing action force 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 10-40 mm.
In the case of electrodes of the same cross-section on each branch lobe, the following forms can be used, but are not limited thereto:
a) the equal spacing and the unequal spacing are adopted for arrangement,
b) arranged in equal length and unequal length forms
c) Arranged in equal and unequal numbers
d) The three conditions are combined in any mode and are freely arranged on different branch valves.
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.
The method is introduced by the arrangement mode of 3 branch lobes 4 electrodes, the electrodes in the branch 1 are selected as shown in fig. 5, the electrode 0, the electrode 1, the electrode 2 and the electrode 3 are named sequentially from the top, the discharging sequence on the branch lobes is 1-2 and 2-3, and the range of the areas with 12 and 23 pulse electric fields is formed as shown in fig. 6.
The electrodes between the branches discharge, and the electrodes discharge pairwise to form annular ablation or orange petal-shaped ablation.
The method is introduced by adopting an electrode arrangement mode of 3 branch lobes 4, namely, a branch 1, a branch 2 and a branch 3 are selected as shown in fig. 5, an electrode 0, an electrode 11, an electrode 21 and an electrode 31 are named sequentially from the top, and the branch lobes adopt discharge sequences of 11-21, 21-31 and 31-11 to form a range of areas with pulse electric fields of A1, A2 and A3 and simultaneously enclose a parallel annular electric field area A, which is shown in fig. 7.
Repeating the steps of the electrode 12, the electrode 22 and the electrode 32 in turn, wherein the discharge sequence on the branch lobes is 12-22, 22-32 and 32-12, so that the areas of the pulse electric fields B1, B2 and B3 are formed, and a parallel annular electric field B area is surrounded; and by analogy of the electrode 13, the electrode 23 and the electrode 33, the discharge sequence on the branch lobes is 13-23, 23-33 and 33-13, the ranges of areas of the pulse electric field C1, C2 and C3 are formed, and a parallel annular electric field C area is enclosed.
The orange-lobe-shaped pulse field D, E, F regions are formed respectively according to the mutual discharge between the electrodes on the front branches, so that a ring-shaped and orange-lobe-shaped mixed electric field is formed, as shown in fig. 8.
The odd side branches have the same polarity, the even side branches have the same polarity, and the branches discharge simultaneously to form rapid annular ablation.
The description is given by the arrangement of 4 branch lobes 4, as shown in fig. 5, a branch 1, a branch 2, a branch 3 and a branch 4 are selected, a branch 13 is used as a positive electrode, a branch 24 is used as a negative electrode, and a discharge sequence of 13-24 is adopted on the branch lobes to form an annular pulse electric field G region, as shown in fig. 9.
The top electrode has one polarity, and the side branches are adjacent to the top electrode and have the same polarity, so that pulse discharge is performed to form planar ablation.
The description is given by the arrangement of 3 branch lobes 4, as shown in fig. 5, branch 1, branch 2 and branch 3 are selected, electrode 0, electrode 11, electrode 21 and electrode 31 are named in sequence from the top, and the discharge sequence is 0-21/21/31, so as to form a toroidal pulse electric field H region, as shown in fig. 10.
The top electrode has one polarity, and the side branch electrodes have the same polarity, so as to perform rapid pulse discharge to form umbrella-shaped ablation.
Introducing by using an arrangement mode of 3 branch lobes 4 electrodes, selecting a branch 1, a branch 2 and a branch 3 as shown in fig. 5, naming an electrode 0 as a positive electrode from the top in sequence, taking all electrodes of the branch 1, the branch 2 and the branch 3 as negative electrodes, and adopting positive and negative electrode discharge to form an umbrella-shaped pulse electric field I area as shown in fig. 11.
The bottom end of the ablation electrode flap is connected with the interface, the interface communicates the electrode flap with the catheter, the electrode lead enters the catheter through the interface, the catheter is a central control cavity, so that an electrode guide wire and a traction metal tube pass through, the length of the catheter is 1-2.5m, and the tail end of the catheter is connected with the handle.
The handle has set up tensile rotatory knob, draws the opening and the shrink of metal pipe control ablation electrode lamella through tensile motion control, opens the gesture through rotatory control electrode lamella, and the handle end is two division binding post, inserts the pulse ablation system respectively, and a terminal is used for the coupling to ablate the pulse, and a terminal is used for coupling cardiac stimulus signal.
The odd electrode lobes and the even electrode lobes of the release pulse of the ablation electrode have one polarity, all electrodes discharge simultaneously, and four electrode lobes are taken as an example: 1. the 3 electrode lobes are of the same polarity, the 2 and 4 electrode lobes are of the same polarity, and the electrode at the farthest end of the electrode lobes does not participate in discharging. The discharge pulse can be a unidirectional square wave, the pulse width is continuously selectable from 2us to 100us, the discharge voltage is not higher than 1000V, and the discharge pulse can also be an alternating pulse sequence (alternating pulse sequence parameter range).
The ablation electrode release pulse takes electrode lobes as units, every two of the electrode lobes release pulses, and four electrode lobes are taken as examples: 1-2, 2-3, 3-4, 4-1, the electrode at the farthest end does not participate in discharging, the discharging pulse can be a unidirectional square wave, the pulse width is 2us-100us continuously selectable, and the discharging pulse can also be an alternating pulse sequence (the parameter range of the alternating pulse sequence).
The release pulse of the ablation electrode is independently addressed by taking the electrode as a unit, every two pulses between the electrodes are released, and taking the example that each valve of the four-valve electrode is provided with 3 electrodes: the electrodes on each electrode lobe can discharge 1-2 and 2-3 pairwise between adjacent electrodes, and the electrodes with the same latitude between adjacent electrode lobes can discharge 1-4, 2-5 and 3-6 pairwise. The discharge pulse between the electrodes can be a unidirectional square wave, the pulse width is continuously selectable from 2us to 100us, and the discharge pulse can also be an alternating pulse sequence (the parameter range of the alternating pulse sequence).
The catheters are classified into 8Fr, 8.5Fr, 9Fr, 9.5Fr, 10Fr, 10.5Fr, 11Fr, 11.5Fr, 12Fr and 12.5Fr according to the number of electrode flaps and the blood vessel condition of a crowd to which the catheters are applied. The catheter is inserted into the left atrium via the femoral vein via an interatrial septum puncture. The guide wire passes through the anti-backflow clamping film through the hollow metal tube to enter a new room, and the guide tube is guided to reach a target position. And pulling the hollow metal tube to open the ablation electrode petals to form a petal shape, and discharging according to a designed discharging sequence.
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 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 (10)
1. An electrode control system for a non-reversible electroporation device, the electrode control system connected to the non-reversible electroporation device, the non-reversible electroporation device comprising a plurality of sets of pulse electrodes and a pulse generator;
the method is characterized in that:
the pulse generator is connected with the pulse output end, the energy storage unit and the discharge unit;
each group of pulse electrodes comprises a first positive phase pulse main electrode and a second reverse phase pulse main electrode;
the first positive phase pulse main electrode and the second negative phase pulse main electrode respectively comprise a plurality of branch lobes, and each branch lobe consists of a plurality of branch electrodes;
the pulse generator sequentially transmits the generated pulse electrical stimulation signals to the first positive phase pulse main electrode and the second negative phase pulse main electrode of the group of pulse electrodes according to time;
the first positive phase pulse main electrode is coupled with a first optical fiber temperature sensor, and the second negative phase pulse main electrodes are coupled with a second optical fiber temperature sensor;
when the absolute value of the difference value between the first temperature detected by the first optical fiber temperature sensor and the second temperature detected by the second optical fiber temperature sensor is greater than a preset value, generating a feedback signal and sending the feedback signal to the electrode control system;
and the electrode control system adjusts the pulse width and the duty ratio of the pulse electric stimulation signal generated by the pulse generator based on the feedback signal.
2. An electrode control system for an irreversible electroporation device according to claim 1, wherein:
the pulse output end is connected with one group of pulse electrodes in the multiple groups of pulse electrodes through a gating device;
the electrode control system 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 electrode control system 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 group of pulse electrodes after waiting for a preset time period.
3. An electrode control system for an irreversible electroporation device according to claim 1, wherein:
the electrode control system 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.
4. An electrode control system for an irreversible electroporation device according to claim 1, wherein:
the pulse generator is communicated with only a first positive phase pulse main electrode and a second negative phase pulse main electrode in a group of pulse electrodes at the same time through the pulse output end;
the pulse generator sequentially transmits the generated pulse electrical stimulation signals to the first positive phase pulse main electrode and the second negative phase pulse main electrode of the group of pulse electrodes according to time, and the pulse generator specifically comprises:
the electrode control system controls the pulse output end to be communicated with the first positive phase pulse main electrode and the second negative phase pulse main electrode at a first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the first positive phase pulse main electrode at the first moment, and transmits the pulse electrical stimulation signal generated by the pulse generator to the second negative phase pulse main electrode at a second moment, wherein the first moment is different from the second moment.
5. An electrode control system for an irreversible electroporation device according to claim 1, wherein:
the first positive-phase pulse main electrode and the second negative-phase pulse main electrode both include a plurality of branch lobes, each branch lobe is composed of a plurality of branch electrodes, and the method specifically includes:
the sectional area of the branch electrodes on each branch valve is the same, and the arrangement mode of the branch electrodes on each branch valve adopts one of the following modes or any combination thereof:
a) the arrangement is carried out in the form of equal spacing and unequal spacing;
b) the equal length and unequal length are adopted for arrangement;
c) arranged in equal and unequal numbers.
6. An electrode control system for an irreversible electroporation apparatus according to claim 1 or 5, wherein:
the electrodes on different branch lobes discharge pairwise, and each branch lobe is used as a discharge side branch to form linear ablation.
7. An electrode control system for an irreversible electroporation apparatus according to claim 1 or 5, wherein:
the electrodes on the same branch valve discharge pairwise to form annular ablation or orange valve-shaped ablation.
8. An electrode control system for an irreversible electroporation apparatus according to claim 1 or 5, wherein:
numbering all the branch electrodes by continuous numerical values;
the odd-numbered branch electrodes are of the same positive polarity, the even-numbered branch electrodes are of the same negative polarity, and the branch electrodes discharge simultaneously to form rapid annular ablation.
9. An electrode control system for an irreversible electroporation apparatus according to any one of claims 1 to 5, wherein:
the first positive phase pulse main electrode directly receives the pulse electrical stimulation signal generated by the pulse generator and distributes the pulse electrical stimulation signal to the branch electrodes of the branch valve to act on the ablation region;
and the second reverse pulse main electrode receives the pulse electrical stimulation signal generated by the pulse generator, performs reverse processing on the pulse electrical stimulation signal, and distributes the pulse electrical stimulation signal to the branch electrodes of the branch valve to act on the ablation region.
10. An electrode control system for an irreversible electroporation apparatus according to any one of claims 1 to 5, wherein:
the electrode control system controls the irreversible electroporation device to couple ablation pulses with cardiac stimulation signals.
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| CN116218666A (en) * | 2023-02-05 | 2023-06-06 | 天津市鹰泰利安康医疗科技有限责任公司 | Electroporation control system based on polymorphic sensing |
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