CN115040233B - Irreversible electroporation tissue ablation system and control method thereof - Google Patents
Irreversible electroporation tissue ablation system and control method thereof Download PDFInfo
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Abstract
The invention relates to the technical field of pulses, and discloses an irreversible electroporation tissue ablation system and a control method thereof, wherein the system comprises the following components: the device comprises a treatment terminal, a central processing module, a pulse sequence generating module and a plurality of pulse electrodes; generating a corresponding control signal by adjusting a combination mode of control button setting pulses on the treatment terminal and sending the control signal to the central processing module; the central processing module determines a corresponding working mode and pulse parameters according to the control signals and outputs the corresponding working mode and pulse parameters to the pulse sequence generating module; the pulse sequence generation module generates a pulse driving signal according to the working mode and the pulse parameters and sends the pulse driving signal to the pulse electrode; the pulse electrode is used for transmitting L nanosecond pulses, M microsecond pulses and N millisecond pulses to the tissue to be ablated after receiving the pulse driving signal. The system can enlarge the effective ablation range by the nanosecond pulse sequence and the microsecond pulse sequence in cooperation with the millisecond pulse sequence, so that the ablation is more thorough.
Description
Technical Field
The invention relates to the technical field of pulses, in particular to an irreversible electroporation tissue ablation system and a control method thereof.
Background
Cancer is a major disease that jeopardizes human health. Traditional therapy of tumors and recently developed thermal ablation physiotherapy featuring minimally invasive ablation have certain limitations in clinical application due to limitations of factors such as indications, contraindications, treatment side effects, thermal ablation and the like. In recent years, with the continuous development of pulse bioelectricity, electric field pulse attracts attention of researchers due to its non-thermal and minimally invasive biomedical effect, while IRE (irreversible electroporation ) for treating tumors has attracted much attention of researchers in the field of bioelectricity both at home and abroad due to its rapid, controllable, visual, selective and non-thermal advantages and features, and has gradually been applied to clinical treatment of tumors.
Irreversible electroporation has been used as an emerging tumor ablation technique to achieve a better effect in clinical applications at home and abroad, however, in reality, tumors are composed of many cells, which are widely different in genetic, transcriptional, phenotypic, etc. in complex and diverse microenvironments. This is also reflected in the differences in the physical properties of the tumour cells, in particular the different cell sizes, the various distorted morphologies and possibly also the different mechanical phenotypes (stiffness, flexibility), which are all caused by the tumour cells in the course of differentiation to adapt to the heterogeneous microenvironment. From an electrical point of view: the tissue acts as a bio-dielectric, and the anisotropic nature of its electrical parameters influences the distribution of the electric field. When the cell sizes are different, the ablation effect of the cells is significantly different, and when the cell sizes are larger, the pulse electric field has better ablation effect. The ablation effect of the pulse electric field on the irregularly shaped cells is affected by the degree of cell malformation, and because the transmembrane potential distribution corresponding to the irregularly shaped cells is asymmetric, the adventitia surface is subjected to electroporation of different degrees, the effect of the pulse electric field is greatly affected, namely, residual tumor cells can be possibly caused in the process of removing tumor tissues, and the ablation is incomplete.
Disclosure of Invention
The invention mainly aims to solve the technical problem that the ablation effect of the existing pulse electric field on irregularly-shaped cells is affected by the degree of cell deformity, so that the ablation is incomplete.
The present invention provides in a first aspect an irreversible electroporation tissue ablation system comprising: the device comprises a treatment terminal, a central processing module, a pulse sequence generating module and a plurality of pulse electrodes; the treatment terminal is provided with a control button, is connected with the central processing module, and generates a corresponding control signal through the treatment terminal by adjusting the combination mode of the control button set pulses and sends the control signal to the central processing module; the central processing module is connected with the pulse sequence generating module, and is used for determining a corresponding working mode and pulse parameters according to the control signal and outputting the working mode and the pulse parameters to the pulse sequence generating module; the pulse sequence generation module is connected with the pulse electrode and is used for generating a pulse driving signal according to the working mode and the pulse parameters and sending the pulse driving signal to the pulse electrode; the pulse electrode acts on the tissue to be ablated of the patient and is used for transmitting L nanosecond pulses, M microsecond pulses and N millisecond pulses to the tissue to be ablated after receiving the pulse driving signal, wherein L is more than or equal to 1, N is more than or equal to 1, and M is more than or equal to 1.
Optionally, in a first implementation manner of the first aspect of the present invention, the pulse sequence generating module is an all-solid-state pulse circuit, and the all-solid-state pulse circuit includes a trigger control circuit, a first pulse generating circuit, a second pulse generating circuit and a power supply; the first pulse generating circuit comprises a first charging resistor, a first high-voltage switch, a first high-voltage arm resistor, a first low-voltage arm resistor, a first energy storage capacitor, a first transformer, a first diode, a first discharging capacitor, a sharpening switch and a second diode; the power supply is connected with one end of the first charging resistor; the other end of the first charging resistor is respectively connected with the high-voltage end of the first high-voltage switch, one end of the first high-voltage arm resistor and one end of the first energy storage capacitor; the low-voltage end of the first high-voltage switch is connected with the ground; the other end of the first high-voltage arm resistor is connected with one end of the first low-voltage arm resistor, and the other end of the first low-voltage arm resistor is connected with the ground; the other end of the first energy storage capacitor is connected with the primary side high-voltage end of the first transformer, the secondary side high-voltage end of the first pulse transformer is connected with the end of the first diode, and the primary side low-voltage end and the secondary side low-voltage end of the first transformer are respectively connected with the ground; the other end of the first diode is connected with one end of the first discharge capacitor and one end of the sharpening switch respectively, and the other end of the first discharge capacitor is connected with the ground; the other end of the sharpening switch is connected with one end of the second diode; the other end of the second diode is used as an output end of the high-voltage pulse forming circuit; the second pulse generating circuit comprises a second charging resistor, a second energy storage capacitor, a second high-voltage arm resistor, a second low-voltage arm resistor, a second high-voltage switch, a third diode, a second transformer and a fourth diode; one end of the second charging resistor is connected with the power supply, and the other end of the second charging resistor is respectively connected with one end of the second energy storage capacitor, one end of the second high-voltage arm resistor and the high-voltage end of the second high-voltage switch; the other end of the second energy storage capacitor is connected with the ground; one end of the third diode is connected with one end of the second high-voltage switch, and the other end of the third diode is connected with the ground; the other end of the second high-voltage arm resistor is connected with one end of a second low-voltage arm resistor, and the other end of the second low-voltage arm resistor is connected with the ground; the low-voltage end of the second high-voltage switch is connected with the primary side high-voltage end of the second transformer, and the primary side low-voltage end of the second transformer is connected with the ground; the secondary side high-voltage end of the second transformer is connected with one end of a fourth diode, and the other end of the fourth diode is used as the output end of the low-voltage pulse forming circuit.
Optionally, in a second implementation manner of the first aspect of the present invention, the nanosecond pulse is a high-voltage pulse, and the microsecond pulse and the millisecond pulse are low-voltage pulses; when nanosecond pulse is required to be output, the trigger control circuit outputs trigger pulse Trig1 to trigger the first high-voltage switch to be closed according to set frequency and time sequence, at the moment, the first energy storage capacitor discharges the primary side of the first transformer, the high-voltage pulse output by the secondary side high-voltage end of the first transformer charges the first discharge capacitor, when the first discharge capacitor charges to reach a peak value, the sharpening switch is conducted, and the first discharge capacitor discharges through the sharpening switch to generate nanosecond high-voltage pulse; when microsecond pulse is required to be output, the control signal output by the trigger control circuit controls the power supply to charge the obtained direct-current high voltage to the second energy storage capacitor through the second charging resistor, when the trigger control circuit detects that the charging voltage of the second energy storage capacitor reaches a set value, the trigger control circuit module outputs a trigger pulse Trig2 according to the set frequency and the time sequence corresponding to the microsecond pulse to trigger the second high-voltage switch to be closed, at the moment, the second energy storage capacitor discharges the primary side of the second transformer, and microsecond low-voltage pulse output is generated on the secondary side of the second transformer; when the trigger control circuit detects that the charging voltage of the second energy storage capacitor reaches a set value, the trigger control circuit module outputs a trigger pulse Trig2 according to the set frequency and the time sequence corresponding to the millisecond pulse to trigger the second high-voltage switch to be closed, at the moment, the second energy storage capacitor discharges the primary side of the second transformer, and millisecond low-voltage pulse output is generated on the secondary side of the second transformer.
Optionally, in a third implementation manner of the first aspect of the present invention, the irreversible electroporation tissue ablation system further includes a real-time detection unit, and the treatment terminal is provided with an oscilloscope; the real-time detection unit is respectively connected with the pulse electrode and the central processing module, and is used for detecting and collecting pulse signals which are emitted by the pulse electrode and act on the tissue to be ablated, and sending the detected and collected pulse signals to the central processing module; and the central processing module sends the pulse signal to an oscilloscope arranged on the treatment terminal, and the pulse signal is displayed through the oscilloscope.
Optionally, in a fourth implementation manner of the first aspect of the present invention, the real-time detection unit is further configured to detect a voltage value of a pulse applied to the tissue to be ablated and a current value flowing through the pulse electrode, and calculate a bioimpedance value of the tissue to be ablated based on the voltage value and the current value.
Optionally, in a fifth implementation manner of the first aspect of the present invention, the irreversible electroporation tissue ablation system further comprises a feedback module; the feedback module is arranged between the central processing module and the real-time detection module, and is used for acquiring the pulse signal and/or the biological impedance value sent by the real-time detection module and the impedance type of the tissue to be ablated sent by the central processing module, generating a feedback signal according to the pulse signal and/or the biological impedance value and the impedance type, and sending the feedback signal to the central processing module; and the central processing module adjusts the control signal sent to the pulse sequence generating module according to the feedback signal.
Optionally, in a sixth implementation manner of the first aspect of the present invention, the pulse electrode is an electrode needle; the nanosecond pulse acts on organelles of cells in the tissue to be ablated within a certain range from the electrode needle, so that irreversible electroporation of the organelles occurs; the microsecond pulse acts on the cell membrane of cells in the tissue to be ablated within a certain range from the electrode needle, so that irreversible electroporation of the cell membrane occurs; the pulse electrode applies the millisecond pulse to cells in the tissue to be ablated, which are located in a certain range away from the electrode needle, so that reversible electroporation occurs on the cells outside the certain range, and the cells with the reversible electroporation are electrolyzed.
A second aspect of the present invention provides a method of controlling an irreversible electroporation tissue ablation system, comprising: generating a corresponding control signal according to a pulse combination mode set by a control button on the treatment terminal; determining and outputting a corresponding working mode and pulse parameters to the pulse sequence generating module according to the control signal by the central processing module; generating a corresponding pulse driving signal based on the working mode and the pulse parameters through the pulse sequence generating module, and sending the pulse driving signal to the pulse electrode; l nanosecond pulses, M microsecond pulses and N millisecond pulses are transmitted to the tissue to be ablated through the pulse electrode, wherein L is more than or equal to 1, N is more than or equal to 1, and M is more than or equal to 1.
In a third aspect, the invention provides an irreversible electroporation tissue ablation system comprising: a memory and at least one processor, the memory having instructions stored therein, the memory and the at least one processor being interconnected by a line; the at least one processor invokes the instructions in the memory to cause the irreversible electroporation tissue ablation system to perform the steps of the control method of the irreversible electroporation tissue ablation system described above.
A fourth aspect of the present invention provides a computer readable storage medium having instructions stored therein which, when run on a computer, cause the computer to perform the steps of the method of controlling an irreversible electroporation tissue ablation system as described above.
In the technical scheme of the invention, an irreversible electroporation tissue ablation system is disclosed, and comprises: the device comprises a treatment terminal, a central processing module, a pulse sequence generating module and a plurality of pulse electrodes; the treatment terminal is provided with a control button, is connected with the central processing module, and generates a corresponding control signal through the treatment terminal by adjusting the combination mode of the control button set pulses and sends the control signal to the central processing module; the central processing module is connected with the pulse sequence generating module, and is used for determining a corresponding working mode and pulse parameters according to the control signal and outputting the working mode and the pulse parameters to the pulse sequence generating module; the pulse sequence generation module is connected with the pulse electrode and is used for generating a pulse driving signal according to the working mode and the pulse parameters and sending the pulse driving signal to the pulse electrode; the pulse electrode acts on the tissue to be ablated of the patient and is used for transmitting L nanosecond pulses, M microsecond pulses and N millisecond pulses to the tissue to be ablated after receiving the pulse driving signal, wherein L is more than or equal to 1, N is more than or equal to 1, and M is more than or equal to 1. The system can enlarge the effective ablation range by the nanosecond pulse sequence and the microsecond pulse sequence in cooperation with the millisecond pulse sequence, so that the ablation is more thorough.
Drawings
FIG. 1 is a schematic representation of a first embodiment of an irreversible electroporation tissue ablation system in accordance with embodiments of the present invention;
FIG. 2 is a schematic view of a second embodiment of an irreversible electroporation tissue ablation system in accordance with embodiments of the present invention;
FIG. 3 is a schematic diagram of a first configuration of an all-solid-state pulse circuit according to an embodiment of the present invention;
FIG. 4 is a schematic diagram of a second configuration of an all-solid-state pulse circuit according to an embodiment of the present invention;
FIG. 5 is a schematic diagram of one embodiment of a method of controlling an irreversible electroporation tissue ablation system in accordance with embodiments of the invention;
FIG. 6 is a schematic diagram of one embodiment of a control device for an irreversible electroporation tissue ablation system in accordance with embodiments of the invention;
FIG. 7 is a waveform diagram of three modes of a first polarity combination of nanosecond pulses, microsecond pulses, and millisecond pulses in an embodiment of the present invention;
FIG. 8 is a diagram of waveforms in three modes for a second polarity combination of nanosecond pulses, microsecond pulses, and millisecond pulses in an embodiment of the present invention;
FIG. 9 is a diagram of waveforms in three modes for a third polarity combination of nanosecond pulses, microsecond pulses, and millisecond pulses in an embodiment of the present invention;
FIG. 10 is a diagram of waveforms in three modes for a fourth polarity combination of nanosecond pulses, microsecond pulses, and millisecond pulses in an embodiment of the present invention;
FIG. 11 is a waveform diagram of three modes of a fifth polarity combination of nanosecond pulses, microsecond pulses, and millisecond pulses in an embodiment of the present invention;
FIG. 12 is a diagram of waveforms in three modes for a sixth polarity combination of nanosecond pulses, microsecond pulses, and millisecond pulses in an embodiment of the present invention;
FIG. 13 is a waveform diagram of three modes of a seventh polarity combination of nanosecond pulses, microsecond pulses, and millisecond pulses in an embodiment of the present invention;
Fig. 14 is a waveform diagram of two modes of an eighth polarity combination of nanosecond pulses, microsecond pulses, and millisecond pulses in an embodiment of the present invention.
Detailed Description
The invention mainly aims to solve the technical problem that the ablation effect of the existing pulse electric field on irregularly-shaped cells is affected by the degree of cell deformity, so that the ablation is incomplete.
The terms "first," "second," "third," "fourth," and the like in the description and in the claims and in the above drawings, if any, are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used may be interchanged where appropriate such that the embodiments described herein may be implemented in other sequences than those illustrated or otherwise described herein. Furthermore, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed or inherent to such process, method, article, or apparatus.
The invention provides an irreversible electroporation tissue ablation system.
For ease of understanding, a frame structure of an irreversible electroporation tissue ablation system in accordance with an embodiment of the present invention is described below with reference to fig. 1, wherein the irreversible electroporation tissue ablation system in accordance with an embodiment of the present invention comprises:
A treatment terminal 101, a central processing module 102, a pulse sequence generation module 103 and a plurality of pulse electrodes 104;
In this embodiment, a control button 105 is disposed on the treatment terminal 101, the treatment terminal 101 is connected to the central processing module 102, and the combination mode of the pulses is set by adjusting the control button 105, and a corresponding control signal is generated by the treatment terminal 101 and sent to the central processing module 102.
Specifically, the combination of the pulses is mainly a polarity combination of nanosecond pulses, microsecond pulses and millisecond pulses, and three working modes corresponding to the polarity combination of each nanosecond pulse, microsecond pulse and millisecond pulse.
Specifically, as shown in fig. 7, by adjusting the control button 105, the polarity combination of the pulses is set to be unipolar by nanosecond pulses, unipolar by microsecond pulses, and unipolar by millisecond pulses, and the corresponding operation modes respectively have an independent mode, a cooperative mode and a continuous mode, wherein the independent mode is a high-voltage nanosecond pulse, a low-voltage microsecond pulse and a low-voltage millisecond pulse which can be independently output and are not interfered with each other; the continuous mode is that high-voltage nanosecond pulse, low-voltage microsecond pulse and low-voltage millisecond pulse can be continuously and alternately output, and no time interval exists among each nanosecond pulse, microsecond pulse and millisecond pulse; the cooperative mode is that high-voltage nanosecond pulse, low-voltage microsecond pulse and low-voltage millisecond pulse are alternately output, and a certain time interval is reserved among the high-voltage nanosecond pulse, the low-voltage microsecond pulse and the low-voltage millisecond pulse.
Specifically, as shown in fig. 8, by adjusting the control button 105, the polarity combination of the pulses is set to be bipolar for nanosecond pulses, unipolar for microsecond pulses, and unipolar for millisecond pulses, and the corresponding operation modes are independent mode, cooperative mode, and continuous mode, respectively.
Specifically, as shown in fig. 9, by adjusting the control button 105, the polarity combination of the pulses is set to be unipolar for nanosecond pulses, bipolar for microsecond pulses, and unipolar for millisecond pulses, and the corresponding operation modes are independent mode, cooperative mode, and continuous mode, respectively.
Specifically, as shown in fig. 10, by adjusting the control button 105, the polarity combination of the pulses is set to be unipolar for nanosecond pulses, unipolar for microsecond pulses, and bipolar for millisecond pulses, and the corresponding operation modes are independent mode, cooperative mode, and continuous mode, respectively.
Specifically, as shown in fig. 11, by adjusting the control button 105, the polarity combination of the pulses is set to be bipolar for nanosecond pulses, bipolar for microsecond pulses, and unipolar for millisecond pulses, and the corresponding operation modes are independent mode, cooperative mode, and continuous mode, respectively.
Specifically, as shown in fig. 12, by adjusting the control button 105, the polarity combination of the pulses is set to be bipolar for nanosecond pulses, bipolar for microsecond pulses, and bipolar for millisecond pulses, and the corresponding operation modes are independent mode, cooperative mode, and continuous mode, respectively.
Specifically, as shown in fig. 13, by adjusting the control button 105, the polarity combination of the pulses is set to be unipolar for nanosecond pulses, bipolar for microsecond pulses, and bipolar for millisecond pulses, and the corresponding operation modes are independent mode, cooperative mode, and continuous mode, respectively.
Specifically, as shown in fig. 14, by adjusting the control button 105, the polarity combination of the pulses is set to be bipolar for nanosecond pulses, bipolar for microsecond pulses, and bipolar for millisecond pulses, and the corresponding operation modes are independent mode and cooperative mode, respectively.
In this embodiment, the central processing module 102 is connected to the pulse sequence generating module 103, and is configured to determine a corresponding working mode and pulse parameters according to the control signal, and output the determined working mode and pulse parameters to the pulse sequence generating module 103.
Specifically, the central processing module 102 is connected with a polarity combination setting module, a working mode setting module and a pulse parameter setting module, the central processing module 102 performs functional setting on the polarity combination setting module through a control signal, and controls the pulse sequence generating module 103 to generate corresponding pulses, wherein the pulse parameters mainly include a pulse width range, a pulse voltage amplitude range and a pulse number, for example, the pulse parameters of nanosecond pulses are set as follows: the width range is [20ns,1000ns ], the voltage amplitude range is [5kV/cm,50kV/cm ], and the nanosecond pulse number N= [1, 5000]; the pulse parameters for the microsecond pulses are set as follows: the width range of microsecond pulses is [1 mu s,100 mu s ], the voltage amplitude range is [ 0.5 kV/cm,5kV/cm ], and the microsecond pulse number M= [1, 5000]; pulse parameters for the millisecond pulse are set as follows: the pulse width range of millisecond pulse is [1ms, 99ms ], the voltage range is [5V/cm,200V/cm ], the millisecond pulse number M= [1, 5000], the pulse parameter is mainly set by the pulse parameter setting module, the polarity setting of the pulse is also one of the pulse parameters, and the pulse parameter setting module is used for setting the pulse parameters in the embodiment.
In this embodiment, the pulse sequence generating module 103 is connected to the pulse electrode 104, and is configured to generate a pulse driving signal according to the operation mode and the pulse parameter and send the pulse driving signal to the pulse electrode 104.
Specifically, as shown in fig. 3, the pulse sequence generating module 103 is an all-solid-state pulse circuit, and the all-solid-state pulse circuit includes a trigger control circuit 1031, a first pulse generating circuit 1032, a second pulse generating circuit 1033, and a power supply 1034.
Further, as shown in fig. 4, the first pulse generating circuit 1032 includes a first charging resistor 10321, a first high voltage switch 10322, a first high voltage arm resistor 10323, a first low voltage arm resistor 10324, a first energy storage capacitor 10325, a first transformer 10326, a first diode 10327, a first discharging capacitor 10328, a sharpening switch 10329, and a second diode 103210; the power supply 1034 is connected with one end of the first charging resistor 10321; the other end of the first charging resistor 10321 is respectively connected with the high-voltage end of the first high-voltage switch 10322, one end of the first high-voltage arm resistor 10323 and one end of the first energy storage capacitor 10325; the low voltage end of the first high voltage switch 10322 is connected with the ground; the other end of the first high-voltage arm resistor 10323 is connected with one end of the first low-voltage arm resistor 10324, and the other end of the first low-voltage arm resistor 10324 is connected with the ground; the other end of the first energy storage capacitor 10325 is connected with the primary side high-voltage end of the first transformer 10326, the secondary side high-voltage end of the first pulse transformer is connected with the end of the first diode 10327, and the primary side low-voltage end and the secondary side low-voltage end of the first transformer 10326 are respectively connected with the ground; the other end of the first diode 10327 is respectively connected with one end of the first discharge capacitor 10328 and one end of the sharpening switch 10329, and the other end of the first discharge capacitor 10328 is connected with the ground; the other end of the sharpening switch 10329 is connected with one end of the second diode 103210; the other end of the second diode 103210 is connected to one end of the equivalent load resistor 1305 and the capacitor 1306 as the output end of the high-voltage pulse forming circuit, and the other ends of the equivalent load resistor 1305 and the capacitor 1306 are connected to the ground. The second pulse generating circuit 1033 includes a second charging resistor 10331, a second energy storage capacitor 10332, a second high-voltage arm resistor 10333, a second low-voltage arm resistor 10334, a second high-voltage switch 10335, a third diode 10336, a second transformer 10337, and a fourth diode 10338; one end of the second charging resistor 10331 is connected with the power supply 1034, and the other end of the second charging resistor 10331 is respectively connected with one end of the second energy storage capacitor 10332, one end of the second high-voltage arm resistor 10333 and the high-voltage end of the second high-voltage switch 10335; the other end of the second energy storage capacitor 10332 is connected with the ground; one end of the third diode 10336 is connected with one end of the second high-voltage switch 10335, and the other end of the third diode 10336 is connected with the ground; the other end of the second high voltage arm resistor 10333 is connected with one end of the second low voltage arm resistor 10334, and the other end of the second low voltage arm resistor 10334 is connected with the ground; the low-voltage end of the second high-voltage switch 10335 is connected with the primary side high-voltage end of the second transformer 10337, and the primary side low-voltage end of the second transformer 10337 is connected with the ground; the secondary high voltage end of the second transformer 10337 is connected with one end of a fourth diode 10338, and the other end of the fourth diode 10338 is used as an output end of the low-voltage pulse forming circuit and is connected with one end of an equivalent load resistor 1035 and one end of a capacitor 1036.
Specifically, when a nanosecond pulse needs to be output, the trigger control circuit 1031 outputs a trigger pulse Trig1 according to a set frequency and a time sequence to trigger the first high-voltage switch 10322 to be closed, at this time, the first energy storage capacitor 10325 discharges the primary side of the first transformer 10326, the high-voltage pulse output by the secondary side high-voltage end of the first transformer 10326 charges the first discharge capacitor 10328, when the first discharge capacitor 10328 charges to reach a peak value, the sharpening switch 10329 is turned on, and the first discharge capacitor 10328 discharges through the sharpening switch 10329 to generate a nanosecond high-voltage pulse;
When a microsecond pulse needs to be output, the control signal output by the trigger control circuit 1031 controls the power supply 1034 to charge the second energy storage capacitor 10332 through the second charging resistor 10331, when the trigger control circuit 1031 detects that the charging voltage of the second energy storage capacitor 10332 reaches a set value, the trigger control circuit 1031 module outputs a trigger pulse Trig2 according to the set frequency and the time sequence corresponding to the microsecond pulse to trigger the second high-voltage switch 10335 to be closed, at the moment, the second energy storage capacitor 10332 discharges the primary side of the second transformer 10337, and microsecond low-voltage pulse output is generated on the secondary side of the second transformer 10337;
When a millisecond pulse needs to be output, the control signal output by the trigger control circuit 1031 controls the power supply 1034 to charge the second energy storage capacitor 10332 through the second charging resistor 10331, when the trigger control circuit 1031 detects that the charging voltage of the second energy storage capacitor 10332 reaches a set value, the trigger control circuit 1031 module outputs a trigger pulse Trig2 according to the set frequency and the time sequence corresponding to the millisecond pulse to trigger the second high-voltage switch 10335 to be closed, at the moment, the second energy storage capacitor 10332 discharges the primary side of the second transformer 10337, and a millisecond low-voltage pulse is generated on the secondary side of the second transformer 10337 to be output.
In this embodiment, the pulse electrode 104 acts on the tissue to be ablated of the patient, and is configured to transmit L nanosecond pulses, M microsecond pulses, and N millisecond pulses to the tissue to be ablated after receiving the pulse driving signal, where L is greater than or equal to 1, N is greater than or equal to 1, and M is greater than or equal to 1.
Specifically, the ablation electrode 104 periodically transmits L nanosecond pulses, M microsecond pulses, and N millisecond pulses to the tissue to be ablated according to the received pulse drive signal.
Specifically, the pulse electrode 104 is an electrode needle, and the nanosecond pulse acts on an organelle of a cell in the tissue to be ablated within a certain range from the electrode needle, so that irreversible electroporation of the organelle occurs; the microsecond pulse acts on the cell membrane of cells in the tissue to be ablated within a certain range from the electrode needle, so that irreversible electroporation of the cell membrane occurs; the pulse electrode 104 applies the millisecond pulse to cells in the tissue to be ablated that are out of a certain range from the electrode needle such that reversible electroporation of cells out of a certain range occurs and cells that exhibit reversible electroporation are electrolyzed.
Specifically, the high-voltage nanosecond pulse can enable the cells close to the electrode needle to generate irreversible electroporation, further enter an apoptosis program, enable the cells far away from the electrode needle to generate reversible electroporation, and enable the high-voltage nanosecond pulse to act on the intracellular organelles in the membrane of the irregular cells close to the electrode needle to realize the electroporation effect of the irregular cells. The organelles include the nuclear membrane, mitochondria, and endoplasmic reticulum, and the irregular cells include normal cells and tumor cells in biological tissues. Microsecond pulses act on the outer membranes of the irregular cells close to the electrode needle to realize irreversible electroporation of the irregular cells, so that necrosis effect of the irregular cells occurs. The low-voltage millisecond pulse sequence can electrolyze cells which are far away from the electrode needle and are subjected to reversible electroporation, because water and electrolyte exist in the cells, under certain electrolysis conditions, the electrolyte can be combined with hydroxide ions generated by the electrolyzed water, so that the concentration of the electrolyte is reduced, osmotic pressure balance, acid-base balance, water balance and the like of the cells can be damaged, and the activity of the cells is further damaged, so that the cells far away from the electrode needle can enter an apoptosis program, and the obtained ablation treatment range is larger and the ablation is more thorough through the technical scheme of nanosecond, microsecond and millisecond pulse sequence combination.
In this embodiment, there is provided an irreversible electroporation tissue ablation system comprising: the device comprises a treatment terminal, a central processing module, a pulse sequence generating module and a plurality of pulse electrodes; the treatment terminal is provided with a control button, is connected with the central processing module, and generates a corresponding control signal through the treatment terminal by adjusting the combination mode of the control button set pulses and sends the control signal to the central processing module; the central processing module is connected with the pulse sequence generating module, and is used for determining a corresponding working mode and pulse parameters according to the control signal and outputting the working mode and the pulse parameters to the pulse sequence generating module; the pulse sequence generation module is connected with the pulse electrode and is used for generating a pulse driving signal according to the working mode and the pulse parameters and sending the pulse driving signal to the pulse electrode; the pulse electrode acts on the tissue to be ablated of the patient and is used for periodically transmitting L nanosecond pulses, M microsecond pulses and N millisecond pulses to the tissue to be ablated according to the pulse driving signal after receiving the pulse driving signal, wherein L is more than or equal to 1, N is more than or equal to 1, and M is more than or equal to 1. The system can enlarge the effective ablation range by the nanosecond pulse sequence and the microsecond pulse sequence in cooperation with the millisecond pulse sequence, so that the ablation is more thorough.
Referring to fig. 2, a second embodiment of an irreversible electroporation tissue ablation system according to an embodiment of the invention is further implemented on the basis of the above embodiment, the apparatus comprising:
the therapeutic terminal 201, the central processing module 202, the pulse sequence generating module 203 and the plurality of pulse electrodes 204;
in this embodiment, a control button 205 is provided on the treatment terminal 201, the treatment terminal 201 is connected to the central processing module 202, and the combination mode of the pulses is set by adjusting the control button 205, and a corresponding control signal is generated by the treatment terminal 201 and sent to the central processing module 202.
In this embodiment, the central processing module 202 is connected to the pulse sequence generating module 203, and is configured to determine a corresponding working mode and pulse parameters according to the control signal, and output the determined working mode and pulse parameters to the pulse sequence generating module 203.
In this embodiment, the pulse sequence generating module 203 is connected to the pulse electrode 204, and is configured to generate a pulse driving signal according to the operation mode and the pulse parameter and send the pulse driving signal to the pulse electrode 204.
In this embodiment, the pulse electrode 204 acts on the tissue to be ablated of the patient, and is configured to periodically transmit L nanosecond pulses, M microsecond pulses, and N millisecond pulses to the tissue to be ablated according to the pulse driving signal after receiving the pulse driving signal, where L is greater than or equal to 1, N is greater than or equal to 1, and M is greater than or equal to 1.
In this embodiment, the irreversible electroporation tissue ablation system further includes a real-time detection unit 206, and an oscilloscope is disposed on the treatment terminal 201;
Specifically, the real-time detection unit 206 is respectively connected to the pulse electrode 204 and the central processing module 202, and is configured to detect and collect a pulse signal that acts on the tissue to be ablated and is emitted on the pulse electrode 204, and send the detected and collected pulse signal to the central processing module 202; the central processing module 202 sends the pulse signal to an oscilloscope arranged on the treatment terminal 201, and the pulse signal is displayed through the oscilloscope.
In practical applications, the real-time detection unit 206 sends the obtained pulse signal to the central processing module 202, the central processing module 202 sends the pulse signal to an oscilloscope set on the treatment terminal 201, the oscilloscope displays the pulse signal, a user can judge whether adjustment is needed by observing the waveform of the pulse signal on the oscilloscope, and when adjustment is needed, the combination of the pulses is reset through the control button 205, so that the pulse signal applied to the tissue to be ablated is changed.
Further, the real-time detection unit 206 is further configured to detect a voltage value of a pulse applied to the tissue to be ablated and a current value flowing through the pulse electrode 204, and calculate a bioimpedance value of the tissue to be ablated based on the voltage value and the current value.
In this embodiment, the irreversible electroporation tissue ablation system further comprises a feedback module 207;
Specifically, the feedback module 207 is disposed between the central processing module 202 and the real-time detection module, and is configured to obtain the pulse signal and/or the bioimpedance value sent by the real-time detection module and the impedance type of the tissue to be ablated sent by the central processing module 202, generate a feedback signal according to the pulse signal and/or the bioimpedance value and the impedance type, and send the feedback signal to the central processing module 202;
the central processing module 202 adjusts the control signal sent to the pulse sequence generating module 203 according to the feedback signal.
In this embodiment, the pulse electrode 204 is an electrode needle;
Specifically, the nanosecond pulse acts on organelles of cells in the tissue to be ablated within a certain range from the electrode needle, so that irreversible electroporation of the organelles occurs; the microsecond pulse acts on the cell membrane of cells in the tissue to be ablated within a certain range from the electrode needle, so that irreversible electroporation of the cell membrane occurs; the pulse electrode 204 applies the millisecond pulse to cells in the tissue to be ablated that are out of a certain range from the electrode needle such that reversible electroporation of cells out of a certain range occurs and cells that exhibit reversible electroporation are electrolyzed.
The embodiment describes in detail the connection relation and the information interaction flow between the circuits on the basis of the previous embodiment, and describes in detail the composition of a cleaning circuit, wherein the cleaning circuit comprises a heating circuit and a temperature control circuit which are connected with the main controller; the heating circuit is arranged on the ablation needle and is used for heating the ablation needle; the temperature control circuit is used for detecting temperature information on the ablation needle, generating a temperature control signal based on the temperature information and controlling the heating temperature output by the heating circuit. According to the embodiment, IRE waves are firstly applied to the ablation needle to conduct irreversible electroporation ablation, after IRE ablation is completed, the ablation needle is heated by the heating assembly, tumor cells remained in the needle tract can be killed after the ablation needle is heated, and therefore the ablation needle is pulled out, and the problem that the tumor cells remained in the needle tract can be transferred is solved.
The method for controlling the irreversible electroporation tissue ablation system according to the embodiment of the present invention is described above, and referring to fig. 5, an embodiment of the method for controlling the irreversible electroporation tissue ablation system according to the embodiment of the present invention includes:
501. Generating a corresponding control signal according to a pulse combination mode set by a control button on the treatment terminal;
502. determining and outputting a corresponding working mode and pulse parameters to the pulse sequence generating module according to the control signal by the central processing module;
503. Generating a corresponding pulse driving signal based on the working mode and the pulse parameters through the pulse sequence generating module, and sending the pulse driving signal to the pulse electrode;
504. And periodically transmitting L nanosecond pulses, M microsecond pulses and N millisecond pulses to the tissue to be ablated through the pulse electrode according to the pulse driving signal, wherein L is more than or equal to 1, N is more than or equal to 1, and M is more than or equal to 1.
In this embodiment, according to the combination mode of the pulses set by the control button on the treatment terminal, a corresponding control signal is generated; determining and outputting a corresponding working mode and pulse parameters to the pulse sequence generating module according to the control signal by the central processing module; generating a corresponding pulse driving signal based on the working mode and the pulse parameters through the pulse sequence generating module, and sending the pulse driving signal to the pulse electrode; and periodically transmitting L nanosecond pulses, M microsecond pulses and N millisecond pulses to the tissue to be ablated through the pulse electrode according to the pulse driving signal, wherein L is more than or equal to 1, N is more than or equal to 1, and M is more than or equal to 1. The method can enlarge the effective ablation range by the nanosecond pulse sequence and the microsecond pulse sequence in cooperation with the millisecond pulse sequence, so that the ablation is more thorough.
Fig. 6 is a schematic diagram of an irreversible electroporation tissue ablation system 600 according to an embodiment of the invention, where the irreversible electroporation tissue ablation system 600 may vary widely depending on configuration or performance, and may include one or more processors (central processing units, CPU) 610 (e.g., one or more processors) and a memory 620, one or more storage mediums 630 (e.g., one or more mass storage devices) storing applications 633 or data 632. Wherein the memory 620 and the storage medium 630 may be transitory or persistent storage. The program stored on the storage medium 630 may include one or more modules (not shown), each of which may include a series of instruction operations in the irreversible electroporation tissue ablation system 600. Still further, the processor 610 may be configured to communicate with the storage medium 630 to execute a series of instruction operations in the storage medium 630 on the irreversible electroporation tissue ablation system 600 to implement the steps of the control method of the irreversible electroporation tissue ablation system described above.
The irreversible electroporation tissue ablation system 600 can also include one or more power sources 640, one or more wired or wireless network interfaces 650, one or more input/output interfaces 660, and/or one or more operating systems 631, such as Windows Serve, mac OS X, unix, linux, freeBSD, and the like. It will be appreciated by those skilled in the art that the configuration of the irreversible electroporation tissue ablation system illustrated in fig. 6 is not limiting of the irreversible electroporation tissue ablation systems provided by the present application, and may include more or fewer components than illustrated, or certain components in combination, or a different arrangement of components.
The present invention also provides a computer readable storage medium, which may be a non-volatile computer readable storage medium, and which may also be a volatile computer readable storage medium, the computer readable storage medium having instructions stored therein which, when executed on a computer, cause the computer to perform the steps of the method of controlling the irreversible electroporation tissue ablation system.
It will be clearly understood by those skilled in the art that, for convenience and brevity of description, the specific working process of the system or apparatus and unit described above may refer to the corresponding process in the foregoing method embodiment, which is not repeated herein.
The integrated units, if implemented in the form of software functional units and sold or used as stand-alone products, may be stored in a computer readable storage medium. Based on such understanding, the technical solution of the present invention may be embodied essentially or in part or all of the technical solution or in part in the form of a software product stored in a storage medium, including instructions for causing a computer device (which may be a personal computer, a server, or a network device, etc.) to perform all or part of the steps of the method according to the embodiments of the present invention. And the aforementioned storage medium includes: a U-disk, a removable hard disk, a read-only memory (ROM), a random access memory (random access memory, RAM), a magnetic disk, or an optical disk, or other various media capable of storing program codes.
The above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims (9)
1. An irreversible electroporation tissue ablation system, the irreversible electroporation tissue ablation system comprising: the device comprises a treatment terminal, a central processing module, a pulse sequence generating module and a plurality of pulse electrodes;
The treatment terminal is provided with a control button, is connected with the central processing module, and generates a corresponding control signal through the treatment terminal by adjusting the combination mode of the control button set pulses and sends the control signal to the central processing module;
The central processing module is connected with the pulse sequence generating module, and is used for determining a corresponding working mode and pulse parameters according to the control signal and outputting the working mode and the pulse parameters to the pulse sequence generating module;
The pulse sequence generation module is connected with the pulse electrode and is used for generating a pulse driving signal according to the working mode and the pulse parameters and sending the pulse driving signal to the pulse electrode;
The pulse electrode acts on the tissue to be ablated of the patient and is used for transmitting L nanosecond pulses, M microsecond pulses and N millisecond pulses to the tissue to be ablated after receiving the pulse driving signal, wherein L is more than or equal to 1, N is more than or equal to 1, and M is more than or equal to 1;
The pulse sequence generation module is an all-solid-state pulse circuit, and the all-solid-state pulse circuit comprises a trigger control circuit, a first pulse generation circuit, a second pulse generation circuit and a power supply;
The first pulse generating circuit comprises a first charging resistor, a first high-voltage switch, a first high-voltage arm resistor, a first low-voltage arm resistor, a first energy storage capacitor, a first transformer, a first diode, a first discharging capacitor, a sharpening switch and a second diode;
The power supply is connected with one end of the first charging resistor; the other end of the first charging resistor is respectively connected with the high-voltage end of the first high-voltage switch, one end of the first high-voltage arm resistor and one end of the first energy storage capacitor; the low-voltage end of the first high-voltage switch is connected with the ground; the other end of the first high-voltage arm resistor is connected with one end of the first low-voltage arm resistor, and the other end of the first low-voltage arm resistor is connected with the ground; the other end of the first energy storage capacitor is connected with the primary side high-voltage end of the first transformer, the secondary side high-voltage end of the first pulse transformer is connected with the end of the first diode, and the primary side low-voltage end and the secondary side low-voltage end of the first transformer are respectively connected with the ground; the other end of the first diode is connected with one end of the first discharge capacitor and one end of the sharpening switch respectively, and the other end of the first discharge capacitor is connected with the ground; the other end of the sharpening switch is connected with one end of the second diode; the other end of the second diode is used as an output end of the high-voltage pulse forming circuit;
The second pulse generating circuit comprises a second charging resistor, a second energy storage capacitor, a second high-voltage arm resistor, a second low-voltage arm resistor, a second high-voltage switch, a third diode, a second transformer and a fourth diode;
One end of the second charging resistor is connected with the power supply, and the other end of the second charging resistor is respectively connected with one end of the second energy storage capacitor, one end of the second high-voltage arm resistor and the high-voltage end of the second high-voltage switch; the other end of the second energy storage capacitor is connected with the ground; one end of the third diode is connected with one end of the second high-voltage switch, and the other end of the third diode is connected with the ground; the other end of the second high-voltage arm resistor is connected with one end of a second low-voltage arm resistor, and the other end of the second low-voltage arm resistor is connected with the ground; the low-voltage end of the second high-voltage switch is connected with the primary side high-voltage end of the second transformer, and the primary side low-voltage end of the second transformer is connected with the ground; the secondary side high-voltage end of the second transformer is connected with one end of a fourth diode, and the other end of the fourth diode is used as the output end of the low-voltage pulse forming circuit.
2. The irreversible electroporation tissue ablation system of claim 1, wherein the nanosecond pulse is a high voltage pulse, the microsecond pulse and the millisecond pulse are low voltage pulses;
If the all-solid-state pulse circuit outputs nanosecond pulses, the trigger control circuit outputs trigger pulses Trig1 according to set frequency and time sequence to trigger the first high-voltage switch to be closed, at the moment, the first energy storage capacitor discharges the primary side of the first transformer, the high-voltage pulses output by the high-voltage end of the secondary side of the first transformer charge the first discharge capacitor, when the charge of the first discharge capacitor reaches a peak value, the sharpening switch is turned on, and the first discharge capacitor discharges through the sharpening switch to generate nanosecond high-voltage pulses;
if the all-solid-state pulse circuit outputs microsecond pulses, the control signal output by the trigger control circuit controls the power supply to charge the obtained direct-current high voltage to the second energy storage capacitor through the second charging resistor, when the trigger control circuit detects that the charging voltage of the second energy storage capacitor reaches a set value, the trigger control circuit module outputs trigger pulse Trig2 according to set frequency and time sequence corresponding to the microsecond pulses to trigger the second high-voltage switch to be closed, at the moment, the second energy storage capacitor discharges the primary side of the second transformer, and microsecond low-voltage pulse output is generated on the secondary side of the second transformer;
And if the all-solid-state pulse circuit outputs millisecond pulse, the control signal output by the trigger control circuit controls the power supply to charge the second energy storage capacitor through the second charging resistor, when the trigger control circuit detects that the charging voltage of the second energy storage capacitor reaches a set value, the trigger control circuit module outputs a trigger pulse Trig2 according to the set frequency and the time sequence corresponding to the millisecond pulse to trigger the second high-voltage switch to be closed, at the moment, the second energy storage capacitor discharges the primary side of the second transformer, and millisecond low-voltage pulse output is generated on the secondary side of the second transformer.
3. The irreversible electroporation tissue ablation system of claim 1, further comprising a real-time detection unit, wherein the treatment terminal is provided with an oscilloscope;
the real-time detection unit is respectively connected with the pulse electrode and the central processing module, and is used for detecting and collecting pulse signals which are emitted by the pulse electrode and act on the tissue to be ablated, and sending the detected and collected pulse signals to the central processing module;
and the central processing module sends the pulse signal to an oscilloscope arranged on the treatment terminal, and the pulse signal is displayed through the oscilloscope.
4. The irreversible electroporation tissue ablation system of claim 3, wherein the real time detection unit is further configured to detect a voltage value of a pulse applied to the tissue to be ablated and a current value flowing through the pulse electrode, and calculate a bioimpedance value of the tissue to be ablated based on the voltage value and the current value.
5. The irreversible electroporation tissue ablation system of claim 4, further comprising a feedback module;
The feedback module is arranged between the central processing module and the real-time detection unit, and is used for acquiring the pulse signal and/or the biological impedance value sent by the real-time detection module and the impedance type of the tissue to be ablated sent by the central processing module, generating a feedback signal according to the pulse signal and/or the biological impedance value and the impedance type, and sending the feedback signal to the central processing module;
And the central processing module adjusts the control signal sent to the pulse sequence generating module according to the feedback signal.
6. The irreversible electroporation tissue ablation system of claim 1, wherein the pulse electrode is an electrode needle;
the nanosecond pulse acts on organelles of cells in the tissue to be ablated within a certain range from the electrode needle, so that irreversible electroporation of the organelles occurs;
The microsecond pulse acts on the cell membrane of cells in the tissue to be ablated within a certain range from the electrode needle, so that irreversible electroporation of the cell membrane occurs;
The pulse electrode applies the millisecond pulse to cells in the tissue to be ablated, which are located in a certain range away from the electrode needle, so that reversible electroporation occurs on the cells outside the certain range, and the cells with the reversible electroporation are electrolyzed.
7. A control method for application to the irreversible electroporation tissue ablation system of any of claims 1-6, the control method comprising:
generating a corresponding control signal according to a pulse combination mode set by a control button on the treatment terminal;
Determining and outputting a corresponding working mode and pulse parameters to the pulse sequence generating module according to the control signal by the central processing module;
Generating a corresponding pulse driving signal based on the working mode and the pulse parameters through the pulse sequence generating module, and sending the pulse driving signal to the pulse electrode;
Transmitting L nanosecond pulses, M microsecond pulses and N millisecond pulses to the tissue to be ablated through the pulse electrode, wherein L is more than or equal to 1, N is more than or equal to 1, and M is more than or equal to 1;
The pulse sequence generation module is an all-solid-state pulse circuit, and the all-solid-state pulse circuit comprises a trigger control circuit, a first pulse generation circuit, a second pulse generation circuit and a power supply;
The first pulse generating circuit comprises a first charging resistor, a first high-voltage switch, a first high-voltage arm resistor, a first low-voltage arm resistor, a first energy storage capacitor, a first transformer, a first diode, a first discharging capacitor, a sharpening switch and a second diode;
The power supply is connected with one end of the first charging resistor; the other end of the first charging resistor is respectively connected with the high-voltage end of the first high-voltage switch, one end of the first high-voltage arm resistor and one end of the first energy storage capacitor; the low-voltage end of the first high-voltage switch is connected with the ground; the other end of the first high-voltage arm resistor is connected with one end of the first low-voltage arm resistor, and the other end of the first low-voltage arm resistor is connected with the ground; the other end of the first energy storage capacitor is connected with the primary side high-voltage end of the first transformer, the secondary side high-voltage end of the first pulse transformer is connected with the end of the first diode, and the primary side low-voltage end and the secondary side low-voltage end of the first transformer are respectively connected with the ground; the other end of the first diode is connected with one end of the first discharge capacitor and one end of the sharpening switch respectively, and the other end of the first discharge capacitor is connected with the ground; the other end of the sharpening switch is connected with one end of the second diode; the other end of the second diode is used as an output end of the high-voltage pulse forming circuit;
The second pulse generating circuit comprises a second charging resistor, a second energy storage capacitor, a second high-voltage arm resistor, a second low-voltage arm resistor, a second high-voltage switch, a third diode, a second transformer and a fourth diode;
One end of the second charging resistor is connected with the power supply, and the other end of the second charging resistor is respectively connected with one end of the second energy storage capacitor, one end of the second high-voltage arm resistor and the high-voltage end of the second high-voltage switch; the other end of the second energy storage capacitor is connected with the ground; one end of the third diode is connected with one end of the second high-voltage switch, and the other end of the third diode is connected with the ground; the other end of the second high-voltage arm resistor is connected with one end of a second low-voltage arm resistor, and the other end of the second low-voltage arm resistor is connected with the ground; the low-voltage end of the second high-voltage switch is connected with the primary side high-voltage end of the second transformer, and the primary side low-voltage end of the second transformer is connected with the ground; the secondary side high-voltage end of the second transformer is connected with one end of a fourth diode, and the other end of the fourth diode is used as the output end of the low-voltage pulse forming circuit.
8. An irreversible electroporation tissue ablation system, the irreversible electroporation tissue ablation system comprising: a memory and at least one processor, the memory having instructions stored therein, the memory and the at least one processor being interconnected by a line;
the at least one processor invokes the instructions in the memory to cause the irreversible electroporation tissue ablation system to perform the steps of the method of controlling an irreversible electroporation tissue ablation system according to claim 7.
9. A computer readable storage medium having stored thereon a computer program, characterized in that the computer program when executed by a processor realizes the steps of the method of controlling the irreversible electroporation tissue ablation system according to claim 7.
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| US20190254735A1 (en) * | 2018-02-21 | 2019-08-22 | Medtronic, Inc. | Focal pulsed field ablation devices and methods |
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