CN217162274U - Pulse electric field generator - Google Patents
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- CN217162274U CN217162274U CN202123336159.5U CN202123336159U CN217162274U CN 217162274 U CN217162274 U CN 217162274U CN 202123336159 U CN202123336159 U CN 202123336159U CN 217162274 U CN217162274 U CN 217162274U
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Abstract
The utility model discloses a pulse electric field generator, include: a set of output channels, each output channel being connected or disconnected to an electrode of a set of electrodes of the ablation device; the pulse generation module is used for generating a pulse sequence and is connected with a group of output channels; the switch module is used for controlling the connection or disconnection between the output channel and the electrode; and the main control module is used for controlling the pulse generation module to generate a pulse sequence during the use period and controlling the switch module to control the output channel to be connected with the electrode, so that the pulse sequence is transmitted to the electrode. The utility model discloses a pulsed electric field generator's pulse generation module generates the pulse sequence under host system's control, and host system still through a set of output channel of switch module control pulse and the break-make between a set of electrode, can accurately deliver the pulse that generates to the tissue that needs were ablated.
Description
Technical Field
The utility model relates to an melt technical field, especially relate to a pulsed electric field generator.
Background
Atrial fibrillation is the most common arrhythmia and catheter ablation is an effective means of restoring and maintaining the heart rhythm in patients with atrial fibrillation. Currently, the commonly used ablation energy is mainly radio frequency energy and is assisted by cryo-energy, and the two ablation methods have advantages and limitations, for example, the ablation energy (cold or heat) has no selectivity for damaging the tissue in the ablation area, depends on the adhesion force of the catheter, and may damage the adjacent esophagus, coronary artery or phrenic nerve, thereby affecting the treatment effect. The pulse ablation is a novel ablation mode taking a high-voltage electric field as energy, is an athermal ablation technology, has tissue selectivity, and can effectively induce the myocardial cells to generate irreversible electroporation by designing a proper pulse electric field and releasing a plurality of high-voltage pulses for a short time so as to break the myocardial cells to die, thereby achieving the purpose of treatment.
SUMMERY OF THE UTILITY MODEL
According to an aspect of the present invention, there is provided a pulsed electric field generator, comprising:
a set of output channels, each output channel being connected or disconnected to an electrode of a set of electrodes of the ablation device;
the pulse generation module is used for generating a pulse sequence and is connected with the group of output channels;
the switch module is used for controlling the connection or disconnection between the output channel and the electrode;
and the main control module is used for controlling the pulse generation module to generate a pulse sequence during the use period and controlling the switch module to control the output channel to be connected with the electrode, so that the pulse sequence is transmitted to the electrode.
The utility model discloses a pulsed electric field generator's pulse generation module generates pulse sequence under host system's control, and host system still through the break-make between a set of output channel of switch module control pulse and a set of electrode, can accurately deliver the pulse that generates to the tissue that needs to melt.
In some embodiments, the ablation device further comprises a set of measurement channels, each measurement channel is respectively connected with or disconnected from one electrode in a set of electrodes of the ablation device, and the electrodes are controlled to be connected with the output channels or the measurement channels through the switch module.
Therefore, the switch module is used for controlling the electrode to be connected with the measuring channel or the output channel, and the function switching of releasing pulses or collecting electric signals is realized.
In some embodiments, the electrode is capable of acquiring an electrical signal at the electrode for transmission through the measurement channel to a master control module when the measurement channel is connected to the electrode during use.
Therefore, the electric signal of the tissue can be collected through the electrode of the ablation device, and the functions of releasing the pulse electric field and collecting the electric signal can be realized in the same device.
In some embodiments, the main control module calculates parameters of a pulse sequence according to the received electrical signal and transmits the parameters to the pulse generation module, so that the pulse generation module generates a corresponding pulse sequence according to the parameters.
Therefore, the parameters of the pulse sequence can be recalculated according to the acquired tissue electric signals, and the pulse sequence is generated according to the parameters and delivered to the tissue, so that the pulse electric field energy which is customized and better accords with the characteristics of the ablated tissue can be generated.
In some embodiments, the pulse generation module comprises a high voltage unit, an energy storage unit, a pulse amplitude control unit and a pulse width control unit;
the high-voltage unit is connected with the energy storage unit and is used for generating high-voltage potential to charge the energy storage unit;
the pulse amplitude control unit is used for controlling the pulse amplitude of the pulse output by the energy storage unit;
the pulse width control unit is used for controlling the pulse width of the pulse output to the energy storage unit by the high-voltage unit.
Therefore, the pulse sequence with adjustable pulse amplitude and adjustable pulse width can be generated to adapt to the pulse ablation needs of different parts and different diseases.
In some embodiments, the pulse generation module further includes an amplitude measurement unit, configured to measure a pulse amplitude value of the output pulse and transmit the measured pulse amplitude value to the main control module, where the main control module compares the received pulse amplitude value with a preset pulse amplitude value;
when the comparison result of the pulse amplitude value of the output pulse and the preset pulse amplitude value is within the error allowable range, the main control module controls the pulse amplitude control unit to adjust the pulse amplitude value of the pulse output at the next moment according to the comparison result;
when the comparison result of the pulse amplitude value of the output pulse and the preset pulse amplitude value exceeds the error allowable range, the main control module controls the switch module to disconnect the output channel from the electrode.
Therefore, the pulse amplitude measurement is carried out on the generated pulse through the amplitude measurement unit, whether the pulse amplitude value of the generated pulse accords with a preset value or not is judged through the main control module, feedback control is formed, namely the pulse amplitude value of the pulse output at the next moment is controlled according to the measurement result, or the pulse output is stopped, so that the pulse electric field generator is safer in use, the pulse amplitude value is adjusted according to feedback, the output pulse accords with set parameters better, and the ablation effect is ensured.
In some embodiments, the pulse generating module further includes a pulse width measuring unit for measuring a pulse width value of the output pulse and transmitting the measured pulse width value to the main control module, and the main control module compares the received pulse width value with a preset pulse width value;
when the comparison result of the pulse width value of the output pulse and the preset pulse width value is within the error allowable range, the main control module controls the pulse width control unit to adjust the pulse width value of the pulse output at the next moment according to the comparison result;
when the comparison result of the pulse width value of the output pulse and the preset pulse width value exceeds the error allowable range, the main control module controls the switch module to disconnect the output channel from the electrode.
Therefore, the pulse width measurement unit is used for measuring the pulse width of the generated pulse, whether the pulse width value of the generated pulse meets a preset value or not is judged through the main control module, feedback control is formed, namely the pulse width value of the pulse output at the next moment is controlled according to the measurement result, or the pulse output is stopped, so that the pulse electric field generator is safer in use, the pulse width value is adjusted according to feedback, the output pulse meets set parameters better, and the ablation effect is guaranteed.
In some embodiments, the pulse generation module further comprises a current measurement unit for measuring a current value of the output pulse and transmitting the measured current value to the main control module;
the main control module compares the received current value with a preset current value;
and when the comparison result of the output current value and the preset current value exceeds the allowable range, the main control module controls the switch module to disconnect the output channel from the electrode.
Therefore, the current measuring unit is used for measuring the current of the generated pulse, the main control module is used for judging whether the current value of the generated pulse meets a preset value or not, and when the current value exceeds the preset value, the switch module is used for immediately disconnecting the output channel from the electrode, so that the safety is ensured.
In some embodiments, the pulse electric field generator further comprises a user control module, the user control module is in bidirectional communication connection with the main control module, the user control module can acquire a user instruction and transmit the user instruction to the main control module, and the main control module analyzes the received user instruction to obtain a control instruction and then controls the pulse electric field generator based on the control instruction; the user control module is provided with a user interface and can display the information from the main control module through the user interface in a graphical interface.
Therefore, the user can accurately control the generation and delivery of the pulse, better realize ablation and can control the running condition of the pulse electric field generator in real time through the user interface.
In some embodiments, the switch module includes a switch driving unit and a set of electronic switches, the switch driving unit is connected with the main control module and the set of electronic switches, and controls the switch states of the set of electronic switches based on the control instruction of the main control module; the set of electronic switches is connected with the set of output channels.
Thereby, the switching between each output channel and the electrode can be controlled individually and/or collectively, the delivery of pulsed energy can be accurately controlled, and the distribution of pulsed electric fields over the electrodes of the ablation device can be controlled.
Drawings
Fig. 1 is a block diagram of a pulsed electric field generator according to some embodiments of the present invention;
fig. 2 is a block diagram of a pulse generation module according to some embodiments of the present invention;
fig. 3 is a waveform diagram of a monophasic pulse sequence generated by a pulsed electric field generator according to some embodiments of the present invention;
fig. 4 is a waveform diagram of a biphasic pulse sequence generated by the pulsed electric field generator according to some embodiments of the present invention;
fig. 5 is a waveform diagram of a bipolar pulse sequence generated by the pulsed electric field generator according to some embodiments of the present invention;
fig. 6 is a waveform diagram of an asymmetric bipolar pulse sequence generated by the pulsed electric field generator according to some embodiments of the present invention.
Detailed Description
The present invention will be described in further detail with reference to the accompanying drawings.
Fig. 1 schematically shows a pulsed electric field generator according to an embodiment of the present invention. As shown, the pulsed electric field generator includes a set of output channels 100, a pulse generation module 200, a switching module 300, a master control module 400, a set of measurement channels 500, and a user control module 600.
A set of output channels 100 connected to the pulse generation module 200 and the electrodes of the ablation device 700, each output channel 100 being connected to or disconnected from one of the set of electrodes of the ablation device 700; an output channel 100 is connected with an electrode, and the connection or disconnection between the two is controlled by the switch module 300, when the two are connected, the pulse generated by the pulse generating module 200 can be delivered to the electrode through the pulse output channel 100, and a pulse electric field is formed by the electrode to ablate the tissue.
As shown in fig. 2, a pulse generating module 200 for generating a pulse sequence is connected to a set of output channels 100; the pulse generating module 200 includes a high voltage unit 210, an energy storage unit 220, a pulse amplitude control unit 230, a pulse width control unit 240, an amplitude measurement unit 250, a pulse width measurement unit 260, a current measurement unit 270, and an electric quantity measurement unit 280.
The high-voltage unit 210 is connected to the energy storage unit 220, and is configured to generate a high-voltage potential to charge the energy storage unit 220; the high voltage unit 210 may be a double half-bridge circuit for generating a high voltage potential to be transmitted to the energy storage unit 220.
The energy storage unit 220 is connected to the output channel 100, pulses output by the energy storage unit 220 are transmitted to the electrodes through the output channel 100, and the energy storage unit 220 may be a capacitor or a capacitor bank composed of a plurality of capacitors.
The pulse amplitude control unit 230 is used for controlling the pulse amplitude of the pulse output by the energy storage unit 220; the pulse amplitude control unit 230 may be a chopper circuit, by which the pulse amplitude of the pulse output from the energy storage unit 220 may be adjusted.
The pulse width control unit 240 is configured to control a pulse width of the pulse output by the high voltage unit 210 to the energy storage unit 220; the pulse width control unit 240 may be an electronic switch set, and pulses with adjustable pulse amplitude, duty ratio and positive and negative polarities can be formed by the on and off time of the electronic switch set so as to meet the pulse ablation needs of different parts and different disease conditions.
The amplitude measuring unit 250 is configured to measure a pulse amplitude value of the output pulse and transmit the pulse amplitude value to the main control module 400, and the main control module 400 compares the received pulse amplitude value with a preset pulse amplitude value; when the comparison result between the pulse amplitude value of the output pulse and the preset pulse amplitude value is within the error allowable range, the main control module 400 controls the pulse amplitude control unit 230 to adjust the pulse amplitude value of the pulse output at the next time according to the comparison result; when the comparison result between the pulse amplitude value of the output pulse and the preset pulse amplitude value exceeds the allowable error range, the main control module 400 controls the switch module 300 to disconnect the output channel 100 from the electrodes. The amplitude measuring unit 250 may sample the voltage of the output point by using two high-voltage precision resistors, and after a series of operational amplifiers, the ADC module feeds back the signal to the main control module 400; the generated pulse is subjected to pulse amplitude measurement by the amplitude measurement unit 250, whether the pulse amplitude value of the generated pulse meets a preset value or not is judged by the main control module 400, and feedback control is formed, namely the pulse amplitude value of the pulse output at the next moment is controlled according to the measurement result, or the pulse output is stopped, so that the pulse electric field generator is safer in use, the pulse amplitude value is adjusted according to feedback, the output pulse meets set parameters better, and the ablation effect is ensured.
The pulse width measuring unit 260 is configured to measure a pulse width value of the output pulse and transmit the pulse width value to the main control module 400, and the main control module 400 compares the received pulse width value with a preset pulse width value; when the comparison result between the pulse width value of the output pulse and the preset pulse width value is within the error allowable range, the main control module 400 controls the pulse width control unit 240 to adjust the pulse width value of the pulse output at the next time according to the comparison result; when the comparison result between the pulse width value of the output pulse and the preset pulse width value exceeds the error allowable range, the main control module 400 controls the switch module 300 to disconnect the output channel 100 from the electrode. The pulse width measurement unit 260 may be of the same hardware design as the amplitude measurement unit 250; the pulse width measuring unit 260 measures the pulse width of the generated pulse, and the main control module 400 judges whether the pulse width value of the generated pulse meets a preset value or not, and forms feedback control, namely the pulse width value of the pulse output at the next moment is controlled according to the measured result, or the pulse output is stopped, so that the pulse electric field generator is safer when in use, and the pulse width value is adjusted according to feedback, so that the output pulse meets the set parameters, and the ablation effect is ensured.
A current measuring unit 270 for measuring a current value of the output pulse and transmitting the measured current value to the main control module 400; the main control module 400 compares the received current value with a preset current value; when the comparison result between the output current value and the preset current value exceeds the allowable range, the main control module 400 controls the switch module 300 to disconnect the output channel 100 from the electrode. The current measuring unit 270 may adopt a current transformer to collect a current signal of the output channel, and feed the signal back to the main control module 400 through the ADC module; the generated pulses are subjected to flow measurement through the current measurement unit 270, whether the current values of the generated pulses meet preset values or not is judged through the main control module 400, and when the current values exceed the preset values, the connection between the output channel 100 and the electrodes is immediately disconnected through the switch module 300, so that the safety is ensured.
The electric quantity measuring unit 280 is connected to the energy storage unit 220 and the main control module 400, and is configured to detect the electric quantity of the energy storage unit 220 and transmit the electric quantity to the main control module 400. The electric quantity information of the energy storage unit 220 is fed back to the main control module 400 in real time, and because the pulse release can be controlled only in the full-electricity state of the energy storage unit 220, the main control module 400 needs to be capable of mastering the electric quantity of the energy storage unit 220 in real time, and the pulse release time can be better mastered.
The pulse sequence generated by the pulse generation module 200 is determined by parameters such as the number of pulses, the amplitude of the pulses, the width of the pulses, and the interval time. Wherein, the number of pulses can be 1-120; the pulse amplitude may be 100-800 volts; the pulse width may be 20-200 microseconds; the time interval may be 40-400 microseconds.
The parameters of the pulse generating module 200 for generating the pulse sequence may be preset in the pulsed electric field generator, and the pulse generating module 200 may be capable of receiving the control signal of the main control module 400, selecting the corresponding preset parameters, and generating the corresponding pulse sequence output according to the preset parameters.
The pulse train may be monophasic, biphasic, bipolar and asymmetric bipolar.
As shown in FIG. 3, in some embodiments, the pulse train is defined as monophasic pulses, which may be positive or negative, with the number of individual monophasic pulses in the pulse train being 1-120, and the pulse amplitude Um 1 May be 100-800 volts, pulse width tw 1 May be 40-400 microseconds with a time interval CP 1 And may be 40-400 microseconds.
As shown in FIG. 4, in some embodiments, the pulse train is defined as biphasic pulses comprising a positive-going voltage and a negative-going voltage, the number of individual biphasic pulses in the pulse train may be 1-60, and the pulse amplitude Um 2 May be 100-800 volts, pulse width tw 2 May be 40-400 microseconds with a time interval CP 2 And may be 40-400 microseconds.
As shown in FIG. 5, in some embodiments, the pulse train is defined as bipolar pulses comprising a positive voltage and a negative voltage, the number of individual bipolar pulses in the pulse train may be 1-60, and the pulse amplitude Um 3 May be 100-800 volts with a pulse width tw 3 May be 40-400 microseconds with a time interval CP 3 May be 40-400 microseconds and the polarity inversion time PIP may be 10-10000 nanoseconds.
The novel energy for ablating the pathological tissue of the human body during the pulse electric field ablation has the advantages of non-thermal effect, selectivity, short time and the like, and can be applied to the ablation in the tumor field and the ablation in the arrhythmia field. Common pulse delivery modes are primarily unipolar pulses and bipolar pulses. These pulses typically have a pulse width of several hundred nanoseconds to several hundred microseconds, and a transmembrane potential can be induced by applying a pulse of a certain pulse width to tissue cellsΔV m The transmembrane potential causing irreversible electroporation of the cells is expressed as Δ V ire Since cells of different tissues have different morphologies, sizes and lipid bilayer results, Δ V of different cells ire In contrast,. DELTA.V ire Typical values of (A) are 200mv-1000 mv. Irreversible electroporation can be caused within 10 μ s after the cells reach the threshold.
One limiting factor of the current pulsed electric field ablation is skeletal muscle contraction, and because unipolar pulses can generate a large direct current component, nerve stimulation can cause muscle contraction, pain and poor patient comfort, the patient needs to be fully anaesthetized and muscle relaxant is used during the operation. While the bipolar pulse mode can reduce the DC component due to the balance of positive and negative directions, but the damage depth of electroporation is limited.
In some embodiments, as shown in fig. 6, a novel pulse train for ablating diseased tissue of a human body is provided, the pulse train being defined as asymmetric bipolar pulses, the asymmetric bipolar pulse train comprising a plurality of positive-going pulses and a negative-going pulse sequentially delivered in chronological order over a period;
pulse amplitude value V of multiple forward pulses p The same;
pulse amplitude value V of negative pulse n Smaller than the pulse amplitude value V of the forward pulse p ；
The pulse width value NPD of the negative-going pulse is greater than the pulse width value PPD of the positive-going pulse.
Therefore, the asymmetrical bipolar pulse sequence provides asymmetrical bidirectional pulses, the comfort of a patient can be improved, and the ablation effect is better. The effect of the positive pulse is to induce Δ V ire Amplitude value V of negative-going pulse n Smaller than the pulse amplitude value V of the forward pulse p And the pulse width value NPD is larger than the pulse width value PPD of the positive pulse, namely the negative pulse has smaller voltage and longer duration compared with the positive pulse, and the direct current component in the pulse period can be reduced to the greatest extent.
The pulse amplitude V of the positive-going pulse in one pulse period as a whole p Integration over timeThe absolute value of which is equal to the pulse amplitude value V of the negative-going pulse n The absolute value of the integration over time or only slightly different. The pulse width value NPD (duration) of the negative going pulses when the pulses are ideal square waves is a function of the number np of positive going pulses and the pulse width value PPD:
NPD×V n ＝PPD×np×V p ；
wherein NPD is the pulse width value, V, of the negative pulse n Is the pulse amplitude value of the negative pulse, PPD is the pulse width value of the positive pulse, np is the number of positive pulses, V p The pulse amplitude value of the forward pulse.
The interval time between the positive-going pulse and the negative-going pulse of the asymmetric bipolar pulse train is a polarity inversion time PIP, which ranges from 10ns to 10000 ns.
Positive pulse interval time t between multiple positive pulses in one period of asymmetric bipolar pulse sequence interval Is in the range of 10ns to 5000 ns.
Asymmetric bipolar pulse one pulse period T ═ np × PPD + (np-1) × T interval +PIP+NPD。
Preferably, the pulse period is generally 3 pulse waveforms, that is, two positive pulses and one negative pulse are sequentially emitted in time sequence, and the two positive pulses have the same pulse amplitude value V p The pulse amplitude value Vn of one negative pulse is smaller than the pulse amplitude value Vp of the positive pulse, on the premise that the load impedance is not changed, the two positive pulses have the same current, the current of one negative pulse is smaller than that of the positive pulse, and the interval t between the two positive pulses is interval 10-5000ns and the polarity inversion time PIP of the bipolar pulse is 10-10000 ns. The range of the pulse width value PPD (duration) of the forward pulse is in the selectable nanosecond or microsecond range, the nanosecond range is 100-1000ns, and the microsecond range is 1-50 mus.
The functional relationship between the pulse width value NPD of the negative pulse, the number np of the positive pulses and the pulse width value PPD is as follows:
NPD×V n ＝2×PPD×V p ；
one pulse period: t2 × PPD + T interval +PIP+NPD；
The pulse period time interval CP4 can be arbitrarily adjusted, with typical values in the range of 1-400 μ s.
Asymmetric bipolar pulse sequences compare to conventional 1: 1 the bipolar pulse of symmetry can furthest reduce direct current component, improves patient's comfort level to can guarantee the damage degree of depth under the condition that reduces direct current component, the effect of melting is guaranteed.
The main control module 400 is used for controlling the pulse generation module 200 to generate a pulse sequence during the use period, and controlling the switch module 300 to control the output channel 100 to be connected with the electrode, so that the pulse sequence is transmitted to the electrode. The main control module 400 is in bidirectional communication connection with the user control module 600, the user control module 600 can receive a user instruction of a user and transmit the user instruction to the main control module 400, and the main control module 400 analyzes the received user instruction to obtain a control instruction so as to control the operation of other modules. The main control module 400 is further connected to the pulse generating module 200, specifically, a user can select a preset pulse sequence through the user control module 600, and the processor controls the pulse generating module 200 to generate a corresponding pulse sequence according to the selected pulse sequence parameter according to a user instruction and output the pulse sequence. The pulse ablation system of the embodiment controls the pulse generation module 200 to generate the pulse sequence through the main control module 400 so as to control the waveform form of the pulse sequence, and switches the preset parameters of different pulse sequences at any time according to the user instruction, so that the pulse generation module 200 generates the pulse sequence with the required waveform form, thereby adapting to the requirements of various conditions in the operation. The main control module 400 also controls the on/off between the group of output channels 100 and the group of electrodes of the pulse through the switch module 300, so that the generated pulse can be accurately delivered to the tissue to be ablated.
The main control module 400 may further include a storage unit, which may store some data to implement a fault detection mechanism of the system, generation and transmission of a pulse sequence, configuration of the state of the electrode output channel 100, selection of a discharge/measurement mode, delivery time of pulse energy, and the like. For example, the memory unit may be configured with normal initial parameters for each module, optimized treatment parameters, algorithms for defining pulse sequences from the intracavitary electrocardiographic signals, clinical data in the form of the distribution of the electric field on the ablation device 700, and the like. The storage unit may be integrated in the main control module 400, or may be separately disposed from the main control module 400, as long as the storage unit is configured to be capable of bi-directional communication with the main control module 400 to realize data access.
A switch module 300 for controlling connection or disconnection between the output channel 100 and the electrode; the switch module 300 includes a switch driving unit and a set of electronic switches, the switch driving unit is connected with the main control module 400 and the set of electronic switches, and controls the on-off state of the set of electronic switches based on the control instruction of the main control module 400; a set of electronic switches is connected to a set of output channels 100, and can individually and/or collectively control the on/off between each output channel 100 and the electrode, accurately control the delivery of pulsed energy, and control the distribution of pulsed electric fields on the electrodes of ablation device 700. Each electronic switch in the group of electronic switches individually controls the on-off between one output channel 100 and the electrode, each electronic switch is controlled by a switch driving unit, and the switch driving unit can control the switching speed and/or the switching position of the electronic switch to control the pulse transmission between the output channel 100 and the electrode. The switch driving unit controls the switching speed and/or the switching position of a group of electronic switches based on the control instruction of the main control module 400 to control the pulse transmission of each electrode on the ablation device 700, thereby controlling the distribution form of the pulsed electric field on the ablation device 700. The state of each electronic switch in a group of electronic switches can be controlled independently, or the states of all electronic switches in a group of electronic switches can be controlled simultaneously. Specifically, the set of electronic switches may include an Insulated Gate Bipolar Transistor (IGBT), a Metal Oxide Semiconductor Field Effect Transistor (MOSFET), a power transistor (GTR), and a gate turn-off thyristor (GTO).
The pulsed electric field generator further comprises double pedals for triggering a signal for controlling the release of the pulse sequence generated by the pulsed electric field generator. One of the pedals is ARM, and the other pedal is PULSE. The pulse release can be finished only by sending signals by two pedals in sequence, and the release mechanism is safer.
The user control module 600 includes a graphical user interface, and a user may input and transmit some parameters to the main control module 400 through the user interface to implement parameter control, and the system operation state or some parameters may be transmitted to the user interface of the user control module 600 through the main control module 400 to be graphically displayed. The user control module 600 may be a touch screen, which may be a resistive screen or a capacitive screen. In some other embodiments, the user control module 600 is integrated with the main control module 400, such as a PC, and the user interface is an interface for the user to communicate with the system, so that the operator can input parameters to the main control module 400 through the user interface, and some data can be displayed on the user interface through a graphic.
A battery icon representing the state of the energy storage unit 220 (capacitor bank) exists in the user interface, when the capacitor bank does not start to be charged, the battery icon is yellow, a battery block representing electric quantity is zero, an "ARM" icon is gray and can not be clicked, a "PULSE" icon is gray and can not be clicked, and the "ARM" icon and the "PULSE" icon in the user interface correspond to the functions of pedal "ARM" and pedal "PULSE" one by one; switching from the uncharged state of the capacitor bank to the charged state, pressing an ARM pedal in the pedals or clicking a battery icon in the user interface; when the capacitor bank starts to be charged and is not fully charged, the battery icon is yellow, the battery block representing the electric quantity gradually rises along with the electric quantity of the capacitor bank, the ARM icon is gray and can not be clicked, and the PULSE icon is gray and can not be clicked; when the capacitor bank is fully charged, the battery icon is changed into green, the battery block is fully charged with the battery icon, the ARM icon is changed into blue, clicking can be performed, and the PULSE icon is gray and cannot be clicked; when the capacitor bank is in a full-power state, pressing an ARM (advanced RISC machines) pedal in the pedals or clicking an ARM icon in a user interface to enter a 10-second countdown state for PULSE energy distribution, wherein a buzzer sounds an alarm tone for clicking every 1 second from entering the state, the ARM icon is changed into grey and is not selectable, and the PULSE icon is changed into blue and is selectable; if the PULSE pedal in the pedals is not pressed within 10 seconds or the PULSE icon in the user interface is clicked, the user interface can not send PULSE energy and directly switches to the interface state that the capacitor bank is fully charged. After the transmission of the pulse energy is completed for one time, the capacitor bank is automatically charged and is switched to the interface state of the capacitor bank in charging. If the capacitor bank is in a fully charged state, no pulse energy is released within 5 minutes, the capacitor bank energy is automatically discharged through the safety loop, and the user interface is switched from the fully charged state to the uncharged state of the capacitor bank.
The PULSE release mechanism of the PULSE electric field generator in the embodiment can release PULSE energy only by triggering two signals within a certain limited time through the ARM icon and the PULSE icon or the pedal icon, thereby avoiding the possibility of false touch, and being provided with an automatic discharge function, so that the PULSE electric field generator is safer in the use process.
A set of measurement channels 500, each measurement channel 500 being connected to or disconnected from an electrode of a set of electrodes of the ablation device 700, the electrodes being controlled by the switching module 300 to be connected to the output channel 100 or the measurement channel 500. Specifically, the measurement channel 500 is further connected to the switch module 300, the switch module 300 is further configured to switch the measurement channel 500 to the output channel 100, that is, the switch module 300 can control the connection of the electrodes to the output channel 100 or the connection of the electrodes to the measurement channel 500, and the main control module 400 can control the switching speed and/or the switching position of the switch module 300, so as to accurately control the electrical signal acquisition of the electrodes on the ablation device 700. The electrical signals collected by the electrodes are transmitted to the main control module 400 through the measurement channel 500, and the main control module 400 analyzes the received electrical signals.
The industry considers that the amplitude of the intracavitary electrocardiogram corresponds to the scar of the tissue, and generally considers that when the voltage of the bipolar intracavitary electrocardiogram is less than 0.1mv, the myocardial tissue of the region is already necrotic.
The main control module 400 may pre-store an algorithm model in a storage unit, and the main control module 400 may call the algorithm model to calculate parameters of the pulse sequence for the received electrical signal (i.e., the intracavitary electrocardiogram signal), and transmit the calculated parameters of the pulse sequence to the pulse generating module 200, so that the pulse generating module generates a corresponding pulse sequence according to the parameters. In some embodiments, the electrical signal acquisition may be performed by the pulse generation module 200 outputting an excitation voltage of low amplitude and specific frequency, the excitation voltage being delivered to the local tissue via the ablation device 100, and the measurement channel 500 acquiring the current value. The main control module 400 can deduce the composition of the tissue by the feedback current value.
After the electric signal is collected, the pulse electric field generator can be switched back to the ablation mode of releasing the pulse, the control switch module 300 controls the electrode to be connected with the output channel 100, and the pulse sequence generated according to the collected electric signal calculation parameters is delivered to the electrode at the corresponding position to ablate the tissue.
The arrangement can calculate the parameters of the pulse sequence according to the acquired tissue electric signals, and generate the pulse sequence according to the parameters to be delivered to the tissue, so that the customized pulse electric field energy which is more consistent with the characteristics of the ablated tissue can be generated.
In the description of the present invention, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element. The terms "connected," "fixed," and the like are to be construed broadly and may, for example, be fixedly connected, detachably connected, integrally connected, or electrically connected; may be directly connected or indirectly connected through an intermediate. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; although the present invention has been described in detail with reference to the foregoing embodiments, it should be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention.
Claims (10)
1. A pulsed electric field generator, comprising:
a set of output channels, each output channel being connected or disconnected to one of a set of electrodes of the ablation device;
the pulse generation module is used for generating a pulse sequence and is connected with the group of output channels;
the switch module is used for controlling the connection or disconnection between the output channel and the electrode;
and the main control module is used for controlling the pulse generation module to generate a pulse sequence during the use period and controlling the switch module to control the output channel to be connected with the electrode, so that the pulse sequence is transmitted to the electrode.
2. The pulsed electric field generator of claim 1 further comprising a set of measurement channels, each measurement channel being connected or disconnected to an electrode of a set of electrodes of the ablation device, the electrodes being controlled by the switching module to be connected to the output channel or the measurement channel.
3. A pulsed electric field generator according to claim 2 wherein the electrodes are capable of acquiring an electrical signal at the electrodes for transmission through the measurement channel to a master control module when the measurement channel is connected to the electrodes during use.
4. The pulsed electric field generator of claim 1, wherein the master module calculates parameters of the pulse sequence from the received electric signals and transmits the parameters to the pulse generation module to generate the corresponding pulse sequence according to the parameters.
5. A pulsed electric field generator according to any one of claims 1 to 4, wherein the pulse generation module comprises a high voltage unit, an energy storage unit, a pulse amplitude control unit and a pulse width control unit;
the high-voltage unit is connected with the energy storage unit and is used for generating high-voltage potential to charge the energy storage unit;
the pulse amplitude control unit is used for controlling the pulse amplitude of the pulse output by the energy storage unit;
the pulse width control unit is used for controlling the pulse width of the pulse output to the energy storage unit by the high-voltage unit.
6. The pulsed electric field generator of claim 5, wherein the pulse generation module further comprises an amplitude measurement unit for measuring a pulse amplitude value of the output pulse and transmitting to the master control module, the master control module comparing the received pulse amplitude value with a preset pulse amplitude value;
when the comparison result of the pulse amplitude value of the output pulse and the preset pulse amplitude value is within the error allowable range, the main control module controls the pulse amplitude control unit to adjust the pulse amplitude value of the pulse output at the next moment according to the comparison result;
when the comparison result of the pulse amplitude value of the output pulse and the preset pulse amplitude value exceeds the error allowable range, the main control module controls the switch module to disconnect the output channel from the electrode.
7. The pulsed electric field generator of claim 5, wherein the pulse generating module further comprises a pulse width measuring unit for measuring a pulse width value of the output pulse and transmitting it to the main control module, and the main control module compares the received pulse width value with a preset pulse width value;
when the comparison result of the pulse width value of the output pulse and the preset pulse width value is within the error allowable range, the main control module controls the pulse width control unit to adjust the pulse width value of the pulse output at the next moment according to the comparison result;
when the comparison result of the pulse width value of the output pulse and the preset pulse width value exceeds the error allowable range, the main control module controls the switch module to disconnect the output channel from the electrode.
8. The pulsed electric field generator of claim 5, wherein the pulse generation module further comprises a current measurement unit for measuring a current value of the output pulse and transmitting the measured current value to the main control module;
the main control module compares the received current value with a preset current value;
and when the comparison result of the output current value and the preset current value exceeds the allowable range, the main control module controls the switch module to disconnect the output channel from the electrode.
9. The pulsed electric field generator of any one of claims 1-4, further comprising a user control module, wherein the user control module is in bidirectional communication with the main control module, the user control module is capable of acquiring a user command and transmitting the user command to the main control module, and the main control module analyzes the received user command to obtain a control command and controls the pulsed electric field generator based on the control command; the user control module is provided with a user interface and can display the information from the main control module through the user interface in a graphical interface.
10. The pulsed electric field generator of any one of claims 1-4 and 6-8, wherein the switch module comprises a switch driving unit and a set of electronic switches, the switch driving unit is connected with the main control module and the set of electronic switches, and the switch states of the set of electronic switches are controlled based on the control instruction of the main control module; the set of electronic switches is connected with the set of output channels.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115562135A (en) * | 2022-12-05 | 2023-01-03 | 安徽省国盛量子科技有限公司 | Parameter configuration method of pulse sequence and generation method and equipment of pulse sequence |
| CN116492043A (en) * | 2022-10-18 | 2023-07-28 | 广州星际悦动股份有限公司 | Pulse light control method, circuit, device, dehairing instrument and storage medium |
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2021
- 2021-12-23 CN CN202123336159.5U patent/CN217162274U/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116492043A (en) * | 2022-10-18 | 2023-07-28 | 广州星际悦动股份有限公司 | Pulse light control method, circuit, device, dehairing instrument and storage medium |
| CN116492043B (en) * | 2022-10-18 | 2024-05-24 | 广州星际悦动股份有限公司 | Pulse light control method, circuit, device, dehairing instrument and storage medium |
| CN115562135A (en) * | 2022-12-05 | 2023-01-03 | 安徽省国盛量子科技有限公司 | Parameter configuration method of pulse sequence and generation method and equipment of pulse sequence |
| CN115562135B (en) * | 2022-12-05 | 2023-03-24 | 安徽省国盛量子科技有限公司 | Parameter configuration method of pulse sequence and generation method and equipment of pulse sequence |
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Denomination of utility model: A pulse electric field generator Granted publication date: 20220812 Pledgee: Bank of China Limited Guangzhou Development Zone Branch Pledgor: Xinhang medical technology (Guangzhou) Co.,Ltd. Registration number: Y2024980029737 |