CN117838283A - Nanosecond pulse ablation system - Google Patents
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Abstract
The application relates to the technical field of medical instruments, in particular to a nanosecond pulse ablation system. The system comprises: an ablation device and an ablation catheter; the ablation equipment comprises a main control module, a high-voltage power supply module, a pulse switching module and an impedance detection module; the ablation catheter includes an ablation assembly and an adjustable bend section; the ablation assembly includes a plurality of ring electrodes; the main control module is respectively in communication connection with the high-voltage power supply module, the pulse switching module and the impedance detection module; the pulse switching module is electrically connected with the ablation catheter; the main control module controls the high-voltage power supply module to output continuously adjustable voltage according to the pulse electrical parameters applied to the focus tissue, which are acquired by the impedance detection module in real time; the main control module controls the pulse switching module to switch the ring electrodes communicated with different positions according to the focus position information acquired by the impedance detection module so as to release high-voltage pulses at the focus position. According to the scheme, normal cells are prevented from being damaged through optimization of the output position and control of the output voltage, and the pulse ablation operation effect is improved.
Description
Technical Field
The application relates to the technical field of medical instruments, in particular to a nanosecond pulse ablation system.
Background
Current catheter ablation is based on radiofrequency energy, but there are other energies as well (including cryo, ultrasound, laser ablation, etc.). However, these ablations based on thermal or cold conduction have limitations in that they lack selectivity for destruction of tissue in the ablation area and, depending on the catheter's applied force, may cause damage to adjacent esophagus, coronary artery, phrenic nerve, etc., often with complications such as esophageal damage, phrenic nerve damage, etc. Unlike traditional energy, the pulse electric field energy forms irreversible micropores on the cell membrane through instant discharge, so that cells are apoptotic, and the aim of non-thermal ablation is achieved, so that the ablation mode is also called irreversible electroporation ablation. In theory, irreversible electroporation ablation can damage target cells without heating tissues, has cell or tissue selectivity, and can effectively protect surrounding key structures, thereby reducing complications in the operation period and reducing the recurrence rate of the illness state.
However, the existing pulse ablation still has difficulty in achieving the output of optimal voltages for different lesion locations, and while causing irreversible electroporation of target cells, loss to normal cells is still unavoidable.
Accordingly, there is a need to provide an improved solution to the above-mentioned deficiencies of the prior art.
Disclosure of Invention
It is an object of the present application to provide a nanosecond pulse ablation system to address or alleviate the problems of the prior art described above.
In order to achieve the above object, the present application provides the following technical solutions:
the present application provides a nanosecond pulse ablation system comprising: an ablation device 1 and an ablation catheter 2;
the ablation device 1 comprises a main control module 11, a high-voltage power supply module 12, a pulse switching module 14 and an impedance detection module;
the ablation catheter 2 comprises an ablation assembly 201 and an adjustable bend section 202; the ablation assembly 201 includes a plurality of ring electrodes 2011;
the main control module 11 is respectively in communication connection with the high-voltage power supply module 12, the pulse switching module 14 and the impedance detection module; the pulse switching module 14 is electrically connected with the ablation catheter 2;
the main control module 11 controls the high-voltage power supply module 12 to output continuously adjustable voltage according to the pulse electric parameters applied to focus tissues acquired by the impedance detection module in real time; the main control module 11 controls the pulse switching module 14 to switch the ring electrodes 2011 communicated with different positions according to the focus position information acquired by the impedance detection module so as to release high-voltage pulses at the focus position.
Optionally, the ablation device 1 further comprises a power module 13; the main control module 11 comprises a first main control module and a second main control module, and the first main control module and the second main control module adopt different types of controllers;
the first main control module is in communication connection with the second main control module; the power module 13 is electrically connected to the high voltage power module 12.
Optionally, the high voltage power supply module 12 includes a DAC module 121 and a power supply module 122;
the DAC module 121 is electrically connected with the power module 122, and the DAC module 121 is in communication connection with the second main control module;
the second main control module controls the DAC module 121 according to the pulse electrical parameter, and further controls the feedback end of the power module 122 to output a continuously adjustable voltage to the power module 13.
Optionally, the power module 13 includes a full-bridge inverter module 131;
the full-bridge inverter module 131 is electrically connected with the power module 122, and the full-bridge inverter module 131 is in communication connection with the first main control module;
the full-bridge inverter module 131 is controlled by the first main control module to output continuously adjustable voltage by changing and controlling the switching frequency of the full-bridge inverter module 131.
Optionally, the power module 13 further includes a boost module 132, a rectifying module 133, and a capacitor pump module 134 sequentially connected to the full-bridge inverter module 131;
the continuously adjustable voltage output by the full-bridge inverter module 131 is sequentially boosted by the boosting module 132, rectified by the rectifying module 133 and stored by the capacitor pump module 134, and is output to the pulse switching module 14 after reaching the pulse energy requirement of the high-voltage pulse.
Optionally, the pulse switching module 14 includes a plurality of switches; two ends of each switch are respectively connected with the corresponding ring electrode 2011;
the switch outputs bipolar positive and negative pulse energy to the ring electrode 2011 under the control of the main control module 11.
Optionally, the impedance detection module includes an acquisition module 15; the acquisition module 15 is electrically connected with the pulse switching module 14; the acquisition module 15 is in communication connection with the first main control module;
the acquisition module 15 detects the high-voltage pulse output by the pulse switching module 14 in real time to acquire a real-time voltage and current analog signal;
the first main control module converts the acquired voltage and current analog signals into digital signals and sends the digital signals to the second main control module;
the second main control module calculates a real-time impedance value according to the digital signal, and controls the high-voltage power supply module 12 to output continuously adjustable voltage according to the real-time impedance value.
Optionally, the ablation catheter 2 includes a tube assembly and a handle 204;
the tube assembly includes an adjustable bend section 202 near the distal end of the tube assembly and a main body section 3 near the proximal end of the tube assembly;
the handle 204 is sequentially connected with the main body section 3, the adjustable bending section 202 and the ablation assembly 201, and the handle 204 is used for controlling the bending degree of the adjustable bending section 202 in the radial plane of the tube assembly so that the ablation assembly 201 can be better attached to a focus.
Optionally, the ablation assembly 201 is annular, and the diameter of the annular is 3mm or more and 30mm or less.
Optionally, the adjustable voltage is a nanosecond high-frequency adjustable voltage.
The technical scheme of the application has the following beneficial effects:
in the application, the impedance detection module can acquire the pulse electrical parameters applied to focus tissues in real time and transmit the pulse electrical parameters to the main control module, the main control module can control the high-voltage power supply module to output continuous adjustable voltage according to the real-time pulse electrical parameters acquired by the impedance detection module, and the main control module can control the pulse switching module to switch the ring electrodes communicated with different positions according to focus position information acquired by the impedance detection module, so that the best high-voltage pulse is output at the focus position. The normal cells are prevented from being damaged by optimizing the output position and controlling the output voltage, the pulse ablation operation effect is improved, and the operation damage is reduced.
Drawings
The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this application, illustrate embodiments of the application and together with the description serve to explain the application and do not constitute an undue limitation to the application. Wherein:
fig. 1 is a schematic diagram of a structure of a nanosecond pulse ablation system provided in accordance with some embodiments of the present application;
fig. 2 is a schematic illustration of a usage scenario of a nanosecond pulse ablation system provided in accordance with some embodiments of the present application;
FIG. 3 is a schematic diagram of bipolar positive and negative pulses provided in accordance with some embodiments of the present application;
FIG. 4 is a schematic diagram of a nanosecond pulse ablation system with continuously adjustable output voltage high voltage pulses provided in accordance with some embodiments of the present application;
FIG. 5 is a schematic diagram of a pulse switching module according to some embodiments of the present application;
FIG. 6 is a schematic diagram of a real-time impedance detection module provided according to some embodiments of the present application;
FIG. 7 is a schematic structural view of an ablation catheter provided in accordance with some embodiments of the present application;
fig. 8 is an enlarged view of a portion of the ablation assembly of fig. 7 provided in accordance with some embodiments of the application.
Reference numerals illustrate:
1-an ablation device; 11-a main control module; 111-a master control module FPGA; 112-a master control module MCU; 12-a high voltage power supply module; a 121-DAC module; 122-a power module; 13-a power module; 131-a full-bridge inversion module; 132-a boost module; 133-rectifying module; 134-a capacitive pump module; 14-a pulse switching module; 15-an acquisition module; 2-an ablation catheter; 201-an ablation assembly; 2011-ring electrode; 202-an adjustable bend section; 3-a body segment; 204-handle.
Detailed Description
The present application will be described in detail below with reference to the accompanying drawings in conjunction with embodiments. Various examples are provided by way of explanation of the present application and not limitation of the present application. Indeed, it will be apparent to those skilled in the art that modifications and variations can be made in the present application without departing from the scope or spirit of the application. For example, features illustrated or described as part of one embodiment can be used on another embodiment to yield still a further embodiment. Accordingly, it is intended that the present application include such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
In the following description, the terms "first/second/third" are used merely to distinguish between similar objects and do not represent a particular ordering of the objects, it being understood that the "first/second/third" may be interchanged with a particular order or precedence where allowed, to enable embodiments of the present application described herein to be implemented in other than those illustrated or described herein.
An embodiment of the present application provides a nanosecond pulse ablation system, as shown in fig. 1 to 8, including: an ablation device 1 and an ablation catheter 2; the ablation device 1 comprises a main control module 11, a high-voltage power supply module 12, a pulse switching module 14 and an impedance detection module; the ablation catheter 2 comprises an ablation assembly 201 and an adjustable bend section 202; the ablation assembly 201 includes a plurality of ring electrodes 2011; the main control module 11 is electrically connected with the high-voltage power supply module 12, the pulse switching module 14 and the impedance detection module respectively; the pulse switching module 14 is electrically connected with the ablation catheter 2; the main control module 11 controls the high-voltage power supply module 12 to output continuously adjustable voltage according to the pulse electric parameters applied to the focus tissue, which are acquired by the impedance detection module in real time; according to the focus position information acquired by the impedance detection module, the pulse switching module 14 is controlled to switch the ring electrodes 2011 communicated with different positions so as to release high-voltage pulses at the focus position.
The ablation device 1 is connected with the ablation catheter 2 through a connecting wire, and the ablation device 1 is used for providing high-voltage pulse to the ablation catheter 2 and controlling the ring electrode 2011 on the ablation catheter 2 to release the high-voltage pulse.
The ablation device 1 comprises a main control module 11, wherein the main control module 11 is respectively in communication connection with a high-voltage power supply module 12, a pulse switching module 14 and an impedance detection module.
The main control module 11 can receive or actively acquire feedback information acquired by the impedance detection module in real time, and the main control module 11 is internally provided with a control algorithm and logic, can automatically generate a control signal according to set parameters and the feedback information acquired by the impedance detection module in real time, and transmits the control signal to the high-voltage power supply module 12, the high-voltage power supply module 12 outputs continuously adjustable voltage under the control of the main control module 11 and provides the voltage to the pulse switching module 14, and the pulse switching module 14 switches ring electrodes 2011 communicated with different positions under the control of the main control module 11 to release high-voltage pulses, so that the automatic adjustment and control of an ablation process are realized, and the accuracy and stability of the ablation process are ensured.
In order to allow an operator to monitor and control the ablation process more conveniently, it will be appreciated that the main control module 11 may be provided with a user-friendly operation interface, for example, may include a display screen, buttons, a control panel, etc., through which the user is allowed to set parameters of the ablation, such as a preset voltage range, time, temperature, etc., and to monitor changes in these parameters in real time during the ablation process.
In this embodiment, the ablation device 1 includes a high-voltage power supply module 12, and the high-voltage power supply module 12 is configured to provide a continuously adjustable voltage for the ablation device 1, which can receive a control signal of the main control module 11, and obtain a stable and accurate output voltage corresponding to a lesion through continuous adjustment. By outputting the continuously adjustable voltage, a voltage value which is adapted to the lesion characteristics in real time is obtained, and then the optimal high-voltage pulse which is matched with the lesion characteristics can be released at the electrode of the ablation catheter 2.
Preferably, the continuously adjustable range of the output voltage is 500V to 2000V.
In some alternative embodiments, the ablation device 1 further comprises a power module 13; the main control module 11 comprises a first main control module and a second main control module; the first main control module is in communication connection with the second main control module; the first main control module and the second main control module adopt different types of controllers. Illustratively, the first master module may be a master module FPGA111 (Field Programmable Gate Array ) and the second master module may be a master module MCU 112 (Microcontroller Unit, micro control unit).
The controller of the main control module FPGA111 is an FPGA, which is an integrated circuit device, and can be programmed by a user after manufacturing to implement a specific digital circuit function, and is mainly used for performing data processing on the collected pulse electrical parameters to generate a processing result, and meanwhile, the main control module FPGA111 also provides a control function.
The controller of the main control module MCU 112 is an MCU, and is a small computer integrated with a Central Processing Unit (CPU), a memory, an input/output interface and other related functions, and the features of high integration level and strong real-time performance can provide timely and stable control capability for the ablation device 1.
In this embodiment, the ablation device 1 further includes a power module 13, where the power module 13 is electrically connected to the high voltage power module 12, and is used to perform power conversion and adjustment on the continuously adjustable voltage output by the high voltage power module 12, so as to obtain a high voltage pulse that meets the treatment requirement.
Under the condition that the main control module 11 includes the first main control module and the second main control module, in order to optimize the control flow, the functions of the first main control module and the second main control module need to be allocated, so the main control module 11 controls the high-voltage power supply module 12 to output continuously adjustable voltage according to the pulse electric parameters applied to the focus tissue, which are acquired by the impedance detection module in real time, specifically: the second main control module controls the high-voltage power supply module 12 to output continuously adjustable voltage to the power module 13 according to the pulse electric parameters, and the power module 13 outputs bipolar positive and negative pulse energy to the ring electrode through the pulse switching module 14 under the drive of the second main control module; or the first main control module outputs a pulse signal with corresponding pulse width through the control power module 13 and outputs the pulse signal to the pulse switching module 14.
In some alternative embodiments, the high voltage power supply module 12 includes a DAC module 121 and a power supply module 122; the DAC module 121 is electrically connected with the power supply module 122, and the DAC module 121 is in communication connection with the second main control module; the second main control module controls the DAC module 121 according to the pulse electrical parameter, and further controls the feedback end of the power module 122, so as to continuously adjust the voltage to the power module 13 towards the power module 13.
As shown in fig. 4, in the present embodiment, the continuously adjustable voltage may be generated by: the main control module 11 communicates with a DAC (Digital-to-Analog Converter) module through an SPI (Serial Peripheral Interface) communication protocol, and sends corresponding control signals to the DAC module 121 according to the pulse electrical parameters. It should be noted that, the main control module 11 in communication with the DAC module 121 is specifically a second main control module, i.e., the main control module MCU 112.
The DAC module 121 receives the control signal, converts the received control signal into an analog signal, and provides the analog signal to the power module 122, and the power module 122 outputs a continuously adjustable voltage according to the analog signal under the control of the main control module 11, and provides the continuously adjustable voltage to the power module 13, and then the power module 13 performs power conversion and adjustment and outputs a high voltage pulse.
Preferably, the main control module 11 controls the feedback end of the power module 122 to realize that the power module 122 outputs continuously adjustable voltage.
Further, the range of the output voltage of the power module 122 may be continuously adjustable within the range of 0-45V.
In another alternative embodiment, the continuously adjustable voltage may be generated by: the power module 13 includes a full-bridge inverter module 131; the full-bridge inverter module 131 is electrically connected with the power supply module 122, and the full-bridge inverter module 131 is in communication connection with the first main control module (the main control module FPGA 111); the full-bridge inverter module 131 is controlled by the first main control module, and the switching frequency of the full-bridge inverter module 131 is controlled by changing, so that the output voltage of the power module 122 is regulated, and further, continuously adjustable voltage is output.
In this embodiment, as shown in fig. 4, the main control module 11 is communicatively connected to the full-bridge inverter module 131, where the main control module 11 is specifically a first main control module, that is, the main control module FPGA111.
At the full-bridge inverter module 131, the main control module FPGA111 can adjust the output voltage by changing and controlling the switching frequency of the full-bridge inverter module 131, so as to output a continuously adjustable voltage.
Specifically, the main control module FPGA111 generates a corresponding control signal according to the pulse electrical parameter, and changes the PWM (Pulse Width Modulation ) signal duty ratio of the full-bridge inverter module 131 by the control signal, so as to change and control the switching frequency of the full-bridge inverter module 131, so as to realize the adjustment of the output voltage to obtain a continuously adjustable voltage.
Further, applicants have found in long-term pulsed electric field ablation (Pulsed Electric Field Ablation, PFA) practice that microsecond PFA (also known in the industry as second generation PFA) still presents problems in causing pain to the patient during use, requiring intraoperative general anesthesia, and also very severe muscle tremors in the patient. Thus, in some alternative embodiments of the present application, the adjustable voltage is a nanosecond high frequency adjustable voltage (Nanosecond Pulsed Electric Field Ablation, nsPFA, nanosecond PFA).
Preferably, the nsPFA energy platform is capable of providing ultra-fast electrical energy pulses for pulse durations from one part per billion seconds to one part per million seconds. Pulses with this property possess the ability to produce transmural continuous lesions by irreversible electroporation with less heat transferred to the diseased tissue.
According to the embodiment, the nanosecond high-frequency adjustable voltage is adopted, so that the characteristics of shorter time and smaller heat of nanosecond PFA pulse emission are utilized, patients hardly feel pain in an ablation process, and the nanosecond PFA has smaller muscle stimulation, so that the patients can complete an operation under ordinary sedation.
After outputting the continuously adjustable voltage, in some alternative embodiments, the power module 13 further includes a boost module 132, a rectifying module 133, and a capacitor pump module 134 sequentially connected to the full-bridge inverter module 131; the continuously adjustable voltage output by the full-bridge inversion module 131 sequentially passes through the boosting module 132 to boost, the rectifying module 133 to rectify and the capacitor pump module 134 to store energy, so that the pulse energy requirement of the high-voltage pulse is met, and then the pulse energy is output to the pulse switching module 14.
As shown in fig. 4, the main control module 11 is communicatively connected to the DAC module 121, the DAC module 121 is electrically connected to the power module 122, the power module 122 is electrically connected to the full-bridge inverter module 131, and the main control module 11 controls the power module 122 to output a continuously adjustable voltage through the DAC module 121 and then provides the continuously adjustable voltage to the boost module 132 through the full-bridge inverter module 131, or the main control module 11 controls the PWM signal to adjust the duty ratio and then provides the continuously adjustable voltage to the boost module 132.
The boost module 132 receives the continuously adjustable voltage, boosts the voltage to a higher output voltage, and supplies the boosted voltage to the rectifying module 133.
The rectifying module 133 receives the boosted voltage, rectifies it, converts it into a stable direct current, and then supplies the rectified voltage to the capacitance pump module 134.
The capacitor pump module 134 is electrically connected to the rectifying module 133, and is configured to boost the dc voltage provided by the rectifying module again, so as to obtain a high voltage pulse meeting the requirement of the ablation electrode.
Preferably, the capacitive pump module 134 includes a switching regulator booster pump, a non-regulated capacitive charge pump, an adjustable capacitive charge pump. The capacitance pump module 134 generates an effect that the output voltage is higher than the input voltage by periodically charging and discharging the capacitor.
According to clinical manifestation, the cardiac pulse ablation still requires good adhesion between the electrode and the target cells, and for this purpose, in this embodiment, the ablation device 1 is provided with an impedance detection module for acquiring in real time the pulse electrical parameters applied to the focal tissue and/or the acquired focal position information, so as to control the ablation parameters and judge the adhesion condition.
In this embodiment, the impedance detection module includes an acquisition module 15; the acquisition module 15 is electrically connected with the pulse switching module 14; the acquisition module 15 is in communication connection with a first master control module (master control module FPGA 111); the acquisition module 15 detects the high-voltage pulse output by the pulse switching module 14 in real time to acquire a real-time voltage and current analog signal; the first main control module converts the acquired voltage and current analog signals into digital signals and sends the digital signals to the second main control module; the second main control module calculates a real-time impedance value according to the digital signal, and controls the high-voltage power supply module 12 to output continuously adjustable voltage according to the real-time impedance value.
As shown in fig. 6, the acquisition module 15 is electrically connected to the pulse switching module 14, and is configured to measure the pulse electrical parameters applied to the focal cells, and perform real-time voltage and current acquisition on the output high-voltage pulse, and provide the acquired real-time voltage and current analog signals to the main control module FPGA111. The main control module FPGA111 acquires the real-time voltage-current analog signal, converts it into a digital signal, and provides it to the main control module MCU 112.
The MCU 112 module of the main control module calculates a real-time impedance value through an internal algorithm or an external Cheng Xuji, and sets a protection point of output voltage after algorithm control according to the characteristic impedance point of the calculated cells so as to achieve the effect of safer and more reliable output.
Meanwhile, the master control module MCU 112 also feeds back the calculated real-time impedance value to the master control module FPGA111. The main control module FPGA111 receives the fed-back impedance value, generates a first pulse control signal according to the impedance value, and applies the first pulse control signal to the power module 13; the first pulse control signal is used for controlling the phase interval and the pulse width of the high-voltage pulse. Meanwhile, the main control module MCU 112 generates a second pulse control signal according to the impedance value, and applies the second pulse control signal to the power module 13, where the second pulse control signal is used to control the pulse number, the group number, and the period of the high voltage pulse. That is, the main control module MCU 112 controls the number of pulses, the number of groups, and the period; the main control module FPGA111 controls the pulse width; different high-voltage pulse parameters are controlled through different pulse control signals, so that mutual interference among the parameters can be avoided, and the whole operation of the system is more stable. And, the control outputs of the main control module FPGA111 and the main control module MCU 112 have a logic relationship, so that the effective output of the high-voltage pulse is ensured.
The power module 13 outputs bipolar positive and negative pulse energy based on the effective first pulse control signal and the effective second pulse control signal under the control of the master control module FPGA111 and the master control module MCU 112, and provides the output bipolar positive and negative pulse energy to the pulse switching module 14; then, the main control module MCU 112 controls the pulse switching module 14, and the pulse switching module 14 outputs the pulse energy to the ablation catheter 2 electrode to generate irreversible perforation on the lesion cells.
Optionally, the master control module FPGA111 and the master control module FPGA111 interact through an SPI communication manner.
Optionally, the real-time impedance value can be used for judging the contact condition, that is, the main control module 11 receives the real-time feedback impedance value through the operation interface, so that the operator can better judge the contact condition of the electrode and the target cell according to the real-time impedance value.
In some alternative embodiments, the pulse switching module 14 includes a plurality of switches; two ends of each switch are respectively connected with the corresponding ring electrode 2011; the switch outputs bipolar positive and negative pulse energy to the ring electrode 2011 under the control of the main control module 11.
As shown in fig. 2 and 3, in the present embodiment, the bipolar positive and negative pulses include a high-voltage positive pulse and a high-voltage negative pulse, wherein the positive pulse and the negative pulse refer to the polarity direction of the electric pulse, that is, the direction of the current flow. Specifically, in a positive pulse, the flow direction of the current is from the positive electrode (high voltage end) to the negative electrode (low voltage end), and in a graph, the positive pulse is generally expressed as a rise phase of the voltage or the current with time. In the negative pulse, the flow direction of the current is from the negative electrode (low voltage end) to the positive electrode (high voltage end), and in the graph, the negative pulse is generally expressed as a period of time in which the voltage or current decreases.
The method can adjust a plurality of parameters of the pulse, such as pulse width, phase interval, pulse period and the like through the master controller. The pulse width refers to the duration of a pulse in one period of a pulse signal; the spacing of pulses refers to the time interval between adjacent pulses; a pulse period refers to the time required for one complete period in a pulse signal.
Alternatively, the pulse width ranges from 1 to 100ns, the phase spacing is 5ns, and the pulse period is 200ns.
Preferably, the switch is of the single pole double throw type. As shown in fig. 5, with this type of relay, the function of positive and negative pulse output between any two electrodes and the function of positive and negative pulse output between multiple electrodes can be realized.
As shown in fig. 5, the pulse switching module 14 connects a high-voltage positive pulse circuit and a high-voltage negative pulse circuit, and a multi-output circuit (i.e., OUT1 to OUTn in fig. 5) is arranged between the high-voltage positive pulse circuit and the high-voltage negative pulse circuit, and each circuit is sequentially connected with a relay An, a ring electrode 2011 and a relay Bn in series. At this time, if the relay A1 is connected to the high-voltage positive pulse, the relay B5 is connected to the high-voltage negative pulse, and the rest relays are connected to the suspension end, the pulse switching module 14 outputs the high-voltage positive pulse between the output circuits OUT1 and OUT 5; if the relay B1 is connected with the high-voltage negative pulse, the relay A2 is connected with the high-voltage positive pulse, and the rest relays are connected with the suspension end, the pulse switching module 14 outputs the high-voltage negative pulse between the output circuits OUT1 and OUT 2; if the relay A1 and the relay A3 are connected with high-voltage positive pulses, the relay B2 and the relay B4 are connected with high-voltage negative pulses, and the rest relays are connected with the suspension end, the pulse switching module 14 outputs high-voltage positive and negative pulses between the output circuits OUT1 and OUT3 and between the output circuits OUT2 and OUT 4.
The pulse switching module 14 is controlled by the main control module 11 to realize the control model, so that the positive and negative pulse output function between any two poles or between any multiple poles can be realized.
The nanosecond pulse ablation system provided by the embodiment comprises an ablation catheter 2, wherein the ablation catheter 2 is connected with an ablation device 1 through a connecting wire. As shown in fig. 7 and 8, the ablation catheter 2 comprises an ablation assembly 201, a handle 204 and a tube assembly; the tube assembly includes an adjustable bend section 202 near the distal end of the tube assembly and a main body section 3 near the proximal end of the tube assembly; the handle 204 is connected to the main body section 3, the adjustable bending section 202 and the ablation assembly 201 in sequence, and the handle 204 is used for controlling the bending degree of the adjustable bending section 202 in the radial plane of the tube assembly so that the ablation assembly 201 is better abutted against the lesion.
Preferably, the ablation assembly 201 is ring-shaped, the outer surface is sleeved with a plurality of ring electrodes 2011 for releasing pulse, the ring electrodes 2011 are used for releasing pulse ablation energy, and the pulse switching mode is used in combination with the plurality of ring electrodes 2011, so that positive pulses or negative pulses can be released on different electrodes under the control of the main control module 11.
Alternatively, the ablation assembly 201 is annular with a diameter of 3mm or more and 30mm or less.
Optionally, the number of the ring electrodes 2011 is 5 to 36.
Optionally, the ring electrode 2011 is also used to map electrophysiological signals in the targeted diseased tissue area.
In summary, the main control module MCU 112 realizes continuous adjustment of the output voltage of 500V-2000V by controlling the high-voltage power module 12, and outputs the output voltage to the power module 13, the main control module FPGA111 realizes accurate control of the pulse width, the main control module MCU 112 realizes accurate control of the pulse number, the group number and the period, and the control outputs of the main control module MCU 112 and the main control module FPGA111 have a logic control relationship, so that effective output of the pulses is ensured. The voltage output by the high-voltage power supply module 12 is stored by the power module 13 and is output to the full-bridge inversion module 131 of the power module 13, pulse signals with different phase intervals are output to the power module 13 by the master control module FPGA111 to drive and control full-bridge inversion, so that bipolar positive and negative pulse energy is output, the master control module MCU 112 flexibly controls the pulse switching module 14 to enable the pulse energy to be output to the electrode of the ablation catheter 2, so that irreversible electroporation is generated on the focal cells, the acquisition module 15 can acquire pulse electrical parameters applied to the focal cells in real time, data processing is carried out by the master control module FPGA111, interactive communication is carried out between the acquisition module and the master control module MCU 112, parameter data are transmitted to the master control module MCU 112, and the master control module MCU 112 calculates a real-time impedance value through algorithm processing. The control module performs data feedback, and the main control module MCU 112 can realize that the power module 13 generates bipolar bidirectional high-voltage pulse energy through the flexible control pulse switching module 14. The pulse switching module 14 is controlled by the main control module 11 to flexibly configure the discharge between any two electrodes of the pulse catheter, so as to cause irreversible electroporation. The acquisition module 15 can acquire the electric pulse parameters on the focus tissue in real time when the pulse is released, and feed back the electric pulse parameters to the master control module FPGA111 (higher acquisition precision) in the master control module 11, the master control module FPGA111 and the master control module MCU 112 are in interactive communication, and the master control module MCU 112 converts the electric pulse parameters into real-time impedance through an algorithm.
The ablation device 1 provided by the application has the continuous adjustable function of output voltage, the output voltage is continuously adjustable within a certain range (500V-2000V), the output pulse number and the output pulse width are adjustable, the operation is more flexible, and the selectivity is larger.
The ablation device 1 provided by the application has a continuous adjustable function of output voltage, the output voltage is nanosecond high-frequency adjustable voltage, and the nanosecond high-frequency adjustable voltage can cause a series of injuries on the level of cell membranes, so that death or apoptosis of target cells is initiated, precise control of ablation is realized, and invasion is reduced.
The ablation equipment 1 provided by the application realizes the pulse switching function under the control of the main control module 11, can flexibly configure the discharge output of positive pulses and negative pulses between any two electrodes according to the condition in operation, and greatly improves the flexibility of clinical treatment.
According to the ablation device 1, the impedance detection function is realized through the impedance detection module, according to clinical manifestation, the heart pulse ablation still needs good adhesion between the electrode and the target cells, according to the information acquired by the electrode, the ablation device 1 can feed back the impedance information in real time through algorithm conversion, and an operator can better judge the adhesion condition of the electrode and the target cells.
The ablation catheter 2 provided by the application has an adjustable bending structure and can adapt to a complex pulmonary vein structure; the far end is in a ring structure, so that the problem of overlap short circuit of the electrode can be solved.
The ablation catheter 2 provided by the application, the ring electrode 2011 is also used for mapping electrophysiological signals in a target tissue region, and an operator can obtain real-time feedback so as to ensure the accuracy and safety of a treatment target. At the same time, the ablation device 1 can be guided to the target area by the ring electrode 2011 and confirmed to be in the correct position. By measuring the electrophysiological signal, specific physiological structures, such as cardiac tissue or neural tissue, can be identified, ensuring that the ablation process occurs at the target region.
The foregoing description is only of the preferred embodiments of the present application and is not intended to limit the same, but rather, various modifications and variations may be made by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application should be included in the protection scope of the present application.
Claims (10)
1. A nanosecond pulse ablation system, comprising: an ablation device (1) and an ablation catheter (2);
the ablation equipment (1) comprises a main control module (11), a high-voltage power supply module (12), a pulse switching module (14) and an impedance detection module;
the ablation catheter (2) comprises an ablation assembly (201) and an adjustable bend section (202); the ablation assembly (201) comprises a plurality of ring electrodes (2011);
the main control module (11) is respectively in communication connection with the high-voltage power supply module (12), the pulse switching module (14) and the impedance detection module; the pulse switching module (14) is electrically connected with the ablation catheter (2);
the main control module (11) controls the high-voltage power supply module (12) to output continuously adjustable voltage according to the pulse electrical parameters applied to focus tissues, which are acquired by the impedance detection module in real time; the main control module (11) controls the pulse switching module (14) to switch the ring electrodes (2011) communicated with different positions according to the focus position information acquired by the impedance detection module so as to release high-voltage pulses at the focus position.
2. The nanosecond pulse ablation system as claimed in claim 1, characterized in that the ablation device (1) further comprises a power module (13); the main control module (11) comprises a first main control module and a second main control module, and the first main control module and the second main control module adopt different types of controllers;
the first main control module is in communication connection with the second main control module; the power module (13) is electrically connected with the high-voltage power supply module (12).
3. The nanosecond pulse ablation system as claimed in claim 2, wherein the high voltage power supply module (12) comprises a DAC module (121) and a power supply module (122);
the DAC module (121) is electrically connected with the power supply module (122), and the DAC module (121) is in communication connection with the second main control module;
the second main control module outputs continuously adjustable voltage to the power module (13) by controlling the DAC module (121) according to the pulse electric parameters and further controlling the feedback end of the power module (122).
4. The nanosecond pulse ablation system as claimed in claim 2, characterized in that the power module (13) comprises a full bridge inverter module (131);
the full-bridge inversion module (131) is electrically connected with the power supply module (122), and the full-bridge inversion module (131) is in communication connection with the first main control module;
the full-bridge inversion module (131) is controlled by the first main control module, and continuously adjustable voltage is output by changing and controlling the switching frequency of the full-bridge inversion module (131).
5. The nanosecond pulse ablation system of claim 4, wherein the power module (13) further comprises a boost module (132), a rectifying module (133), and a capacitive pump module (134) connected in sequence with the full-bridge inverter module (131);
the continuously adjustable voltage output by the full-bridge inversion module (131) is sequentially boosted by the boosting module (132), rectified by the rectifying module (133) and stored by the capacitor pump module (134), and the continuously adjustable voltage is output to the pulse switching module (14) after reaching the pulse energy requirement of high-voltage pulses.
6. The nanosecond pulse ablation system of claim 4 or 5, wherein the pulse switching module (14) comprises a plurality of switches;
two ends of each switch are respectively connected with the corresponding ring electrode (2011);
the switch outputs bipolar positive and negative pulse energy to the ring electrode (2011) under the control of the main control module (11).
7. The nanosecond pulse ablation system as claimed in claim 2, characterized in that the impedance detection module comprises an acquisition module (15); the acquisition module (15) is electrically connected with the pulse switching module (14); the acquisition module (15) is in communication connection with the first main control module;
the acquisition module (15) detects the high-voltage pulse output by the pulse switching module (14) in real time so as to acquire a real-time voltage and current analog signal;
the first main control module converts the acquired voltage and current analog signals into digital signals and sends the digital signals to the second main control module;
the second main control module calculates a real-time impedance value according to the digital signal, and controls the high-voltage power supply module (12) to output continuously adjustable voltage according to the real-time impedance value.
8. The nanosecond pulse ablation system of claim 1, wherein the ablation catheter (2) comprises a tube assembly and a handle (204);
the tube assembly includes an adjustable bend section (202) near a distal end of the tube assembly and a main body section (3) near a proximal end of the tube assembly;
the handle (204) is sequentially connected with the main body section (3), the adjustable bending section (202) and the ablation assembly (201), and the handle (204) is used for controlling the bending degree of the adjustable bending section (202) in a radial plane of the tube assembly so that the ablation assembly (201) is better attached to a focus.
9. The nanosecond pulse ablation system of claim 1, wherein the ablation assembly (201) is ring-shaped with a diameter of 3mm to 30 mm.
10. The nanosecond pulse ablation system of any one of claims 1-9, wherein the adjustable voltage is a nanosecond high frequency adjustable voltage.
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| CN202410093840.0A CN117838283A (en) | 2024-01-23 | 2024-01-23 | Nanosecond pulse ablation system |
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| CN202410093840.0A CN117838283A (en) | 2024-01-23 | 2024-01-23 | Nanosecond pulse ablation system |
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| CN114366284A (en) * | 2022-01-27 | 2022-04-19 | 苏州心岭迈德医疗科技有限公司 | Ablation catheter and device |
| CN116669643A (en) * | 2021-01-22 | 2023-08-29 | Crc Ep公司 | Ablation catheter and method of operating the same |
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| CN104582619A (en) * | 2012-04-26 | 2015-04-29 | 麦德托尼克消融前沿有限公司 | System for detecting tissue contact during ablation |
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| CN116669643A (en) * | 2021-01-22 | 2023-08-29 | Crc Ep公司 | Ablation catheter and method of operating the same |
| CN114343834A (en) * | 2021-12-16 | 2022-04-15 | 上海玮启医疗器械有限公司 | Pulse ablation control device and pulse ablation system |
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