CN113768616A - Integrated system for cardiac ablation - Google Patents
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Abstract
The invention relates to the technical field of cardiac ablation, in particular to a comprehensive system for cardiac ablation, which comprises a pulsed electric field ablation device, a three-dimensional mapping system, a radiofrequency device and an ablation catheter, wherein the pulsed electric field ablation device comprises a magnetic signal receiving module, an electric signal receiving module, a pressure receiving module and an impedance detection module, and respectively transmits the electric signal, the magnetic signal, the pressure signal and the impedance signal of the catheter to the three-dimensional mapping system; the three-dimensional mapping system analyzes and processes the signals to obtain electrophysiological information of the patient, position information of the catheter and the attaching state of the operating position of the catheter. Under the control of the three-dimensional mapping system, the system also realizes the switching of the pulse signal output by the pulse electric field ablation device and the radio frequency signal output by the radio frequency instrument. The integrated system is more complete in design, the output of pulse electric field energy and radio frequency energy can be realized through one set of ablation catheter, the three-dimensional calibration is realized, and the operation is simpler and more convenient.
Description
Technical Field
The invention relates to the technical field of cardiac ablation, in particular to a comprehensive system for cardiac ablation.
Background
The existing thermal ablation means mainly adopt radio frequency and freezing technologies. However, this thermal ablation technique is limited by the heat sink effect during use and often makes it difficult to achieve full-thickness transmural. Meanwhile, these thermal ablation techniques do not have cell selectivity, and thus damage non-target cells together.
In view of the above drawbacks of thermal ablation techniques, pulsed electric field ablation techniques are gaining increasing attention as an athermal ablation technique. The pulsed electric field ablation technology is to generate a high-voltage pulsed electric field with the pulse width of millisecond, microsecond or even nanosecond, and release extremely high energy in a short time, so that a large number of irreversible micropores can be generated in cell membranes and even intracellular organelles such as endoplasmic reticulum, mitochondria, cell nucleus and the like. Further causing the apoptosis of the pathological cells, thereby achieving the expected treatment purpose.
Based on the advantages, the pulsed electric field ablation technology is expected to become an ideal surgical ablation technology, and particularly has more obvious effect in the field of cardiac ablation.
Pulsed electric field ablation techniques are inherently good, but how to integrate them into existing cardiac surgery systems is a matter of significant consideration for the application of the technique. However, there is no better scheme for integrating the cardiac surgery system and the pulsed electric field ablation system in the existing market, and there is no application of combining the pulsed electric field ablation system with the three-dimensional mapping system, and there is no prior art for system integration of pulsed electric field ablation and radio frequency ablation.
Disclosure of Invention
In order to better use the existing pulsed electric field ablation technology in the cardiac treatment operation and solve the problem of integration and application of the existing pulsed electric field technology in the cardiac treatment operation, the invention integrates the pulsed electric field ablation device, the three-dimensional mapping system and the radio frequency instrument, is convenient for a user to select corresponding functions according to actual conditions, and provides a comprehensive system for cardiac ablation.
In order to achieve the above purpose, the invention provides the following technical scheme:
an integrated system for cardiac ablation, which comprises a pulsed electric field ablation device, a three-dimensional mapping system, a radiofrequency instrument and an ablation catheter,
the pulsed electric field ablation device comprises a pulsed electric field generating module, wherein the pulsed electric field generating module is used for outputting a pulsed electric field signal to the ablation catheter; the pulsed electric field ablation device further comprises a magnetic signal receiving module, an electric signal receiving module, a pressure receiving module and an impedance detection module, the magnetic signal, the electrocardiosignal, the pressure signal and the impedance signal are respectively received through the ablation catheter, and the magnetic signal, the electrocardiosignal, the pressure signal and the impedance signal are transmitted to the three-dimensional mapping system; the pulsed electric field ablation device also receives a calibration signal output by the three-dimensional mapping module, outputs the calibration signal to the ablation catheter and outputs a calibration return signal to the three-dimensional mapping system;
the three-dimensional mapping system comprises a three-dimensional mapping module, a magnetic signal analysis and processing module, an electrocardiosignal analysis and processing module, a pressure analysis and processing module, an impedance analysis and processing module and a modeling navigation and electrophysiological module, wherein the three-dimensional mapping module realizes the calibration of the ablation catheter according to a calibration return signal obtained from the pulsed electric field ablation device; the three-dimensional mapping system further analyzes and processes the magnetic signal, the electrocardiosignal, the pressure signal and the impedance signal respectively to obtain position information of the catheter, electrophysiological information of the patient and the attaching state of the catheter operation position, and the three-dimensional mapping system further realizes the establishment of a heart model and the navigation of the ablation catheter by a modeling navigation and electrophysiological module by taking the position information of the catheter as guidance; the three-dimensional mapping system is further used for controlling the switching between the pulsed electric field signal and the filtered radio frequency ablation signal;
the radio frequency instrument is used for outputting a radio frequency ablation signal to a filtering module of the three-dimensional mapping system to filter interference and outputting the filtered radio frequency ablation signal to the pulsed electric field ablation device;
the ablation catheter is connected with the pulsed electric field ablation device, is used for outputting the pulsed electric field signal or the filtered radio frequency ablation signal, acquiring the magnetic signal, the electrocardiosignal, the pressure signal and the impedance signal, and outputting the magnetic signal, the electrocardiosignal, the pressure signal and the impedance signal to the pulsed electric field ablation device, and is also used for returning a calibration return signal to the pulsed electric field ablation device according to the calibration signal.
As a preferred scheme of the present invention, the pulsed electric field ablation device further includes a switch switching matrix, the output of the pulsed electric field signal or the filtered rf ablation signal in the ablation catheter is realized by switching of the switch switching matrix, and the magnetic signal, the ecg signal, the pressure signal, the impedance signal, and the calibration return signal are further acquired by switching of the switch switching matrix.
As a preferred scheme of the present invention, under the switching control of the switching matrix, when the pulsed electric field signal is output in the ablation catheter, the transmission channel of the magnetic signal, the electrocardiographic signal, the pressure signal, the impedance signal and the calibration return signal is cut off; when the radiofrequency ablation signal is output in the ablation catheter, the magnetic signal, the electrocardiosignal, the pressure signal, the impedance signal and the calibration return signal are transmitted simultaneously.
As a preferred embodiment of the present invention, the impedance detection module realizes the detection of the adhering state of the catheter operation position by three modes, i.e., time-division switching detection, fusion extraction detection, and frequency-division switching detection.
As a preferred scheme of the present invention, when the impedance detection module adopts a time-sharing switching detection mode, the sampling circuit and the excitation are connected with the catheter through the electrode channel switch, the excitation signal and the sampling signal of the sampling circuit are loaded onto the corresponding catheter through the electrode channel switch, and the excitation signal is loaded and the sampling signal is obtained through the time-sharing switching of the electrode channel switch, so as to obtain the impedance value of the electrode loop of the ablation catheter.
As a preferred embodiment of the present invention, when the impedance detection module adopts a frequency division switching detection method, n sampling circuits and n excitations are respectively connected to the conduit, and only one excitation signal is applied to the conduit at the same time, and the sampling circuits acquire an impedance value of an electrode loop of the conduit according to their own sampling frequency.
As a preferred scheme of the present invention, when the impedance detection module adopts a fusion extraction detection manner, n sampling circuits and n excitations are adopted, wherein the n excitations are connected with the conduit through the excitation fusion module, the n sampling circuits are respectively connected with the conduit through the signal extraction module, the n corresponding excitation signals of the excitations are different, and the n sampling circuits respectively obtain impedance values of electrode loops corresponding to the conduit through the signal extraction module.
As a preferred scheme of the present invention, the filtering module is further configured to filter the electrocardiographic signal output by the electrical signal receiving module, and output the filtered electrocardiographic signal to the electrocardiographic signal analyzing and processing module.
As a preferable scheme of the invention, the pulsed electric field ablation device further comprises a catheter identification module, wherein the catheter identification module is used for identifying different types of cardiac pulse ablation catheters and realizing parameter configuration, control characteristic configuration and channel configuration of the different types of cardiac pulse ablation catheters, and the channel configuration is realized through a switch switching matrix.
As a preferred aspect of the present invention, the pulsed electric field ablation device further includes a self-test module, and a work flow of the self-test module includes the following steps:
s1, start pulse or pre-pulse;
s2, judging the load condition of the connection of the conduit, executing the step S3 when the load condition of the connection of the conduit is judged to be normal, otherwise, entering a safety state and alarming;
s3, outputting internal prepulse, judging whether an internal switching tube and a detection circuit are normal, executing the step S4 when the internal switching tube and the detection circuit work normally, and otherwise, entering a safety state and giving an alarm;
and S4, the self-checking is successful, and the corresponding pulse output or pre-pulse function is started.
As a preferred scheme of the present invention, the pulsed electric field ablation apparatus further comprises a pre-pulse module, wherein the pre-pulse module operates in a pre-perforation mode or a pre-test mode, and the pre-pulse module controls output parameters in the pre-perforation mode, so that the myocardial cells generate reversible perforation; in a pretest mode, the pre-pulse module measures electrical parameters before and after ablation, and determines the pulse electric field ablation effect by comparing the variation of the electrical parameters before and after ablation.
The heart pulse electric field ablation catheter further comprises an infusion pump, wherein the infusion pump comprises an infusion control module, and the infusion control module is used for controlling the cooling liquid to flow in the heart pulse electric field ablation catheter and reducing local high temperature generated on the catheter.
Compared with the prior art, the invention has the beneficial effects that:
1. the invention provides a comprehensive system for cardiac ablation, which comprises a pulsed electric field ablation device, a three-dimensional mapping system and a radio frequency instrument, wherein the output of pulsed electric field energy, the output of radio frequency energy and three-dimensional calibration can be realized through a set of ablation catheters, according to the actual use condition, the output energy can be switched between the pulsed electric field energy and the radio frequency ablation energy under the switching of a switch switching matrix in the pulsed electric field ablation device, and electric signals, magnetic signals, pressure signals and impedance signals are collected so as to be used for monitoring the position of the catheters, the state of a patient and the ablation effect.
2. The invention provides three impedance detection modes of time-sharing switching detection, fusion extraction detection and frequency division switching detection, and is convenient for a user to flexibly select different impedance detection modes according to requirements.
3. The filtering module in the three-dimensional mapping system has dual functions, on one hand, the filtering module filters the radio-frequency signal output by the radio-frequency instrument and then outputs the filtered radio-frequency signal to the switch switching matrix of the pulsed electric field ablation device, so that clutter and interference in the radio-frequency signal are reduced; the filtering module is also used for filtering clutter from the acquired electrophysiological signals and then outputting the filtered electrophysiological signals to the electrocardiosignal analyzing and processing module, so that the result obtained by the electrocardiosignal analyzing and processing module is more accurate.
4. The matching of various types of catheters and the system is realized through the catheter identification module, and when the catheters are matched, the action range of the electric field of the catheters can be estimated without energy output, the visualization of the action range of the electric field of the catheters is realized, and an operator is guided to correct parameters or replace the catheters.
5. The system integrates a self-checking module which allows output under the condition that the conduit is connected with a load and the inside of the pulse electric field device is correct, and the output or the pre-pulse starting is carried out each time, so that the safety of the use of each pulse is ensured.
6. The pulsed electric field ablation device also comprises a pre-pulse module, wherein the pre-pulse module works in a pre-perforation mode or a pre-test mode, and in the pre-perforation mode, the pre-pulse module controls output parameters to enable the myocardial cells to generate reversible perforation and predict the pulsed electric field ablation effect; in a pretest mode, the pre-pulse module measures electrical parameters before and after ablation, and determines the pulse electric field ablation effect by comparing the variation of the electrical parameters before and after ablation.
7. The system also includes an infusion pump including an infusion control module for controlling a flow of a cooling liquid at the cardiac pulsed electric field ablation catheter for reducing localized high temperatures generated on the catheter.
Description of the drawings:
fig. 1 is a system block diagram of an integrated system for cardiac ablation in accordance with embodiment 1 of the present invention;
fig. 2 is a schematic data interaction diagram of a three-dimensional mapping system and a pulsed electric field ablation device according to embodiment 1 of the present invention;
fig. 3 is a schematic diagram of three implementation manners of the impedance detection module in embodiment 1 of the present invention;
fig. 4 is a schematic structural diagram of an impedance time-sharing detection portion in embodiment 1 of the present invention;
fig. 5 is a schematic structural diagram of an impedance frequency division detecting part in embodiment 1 of the present invention;
FIG. 6 is a schematic view of the fusion extraction detection section in embodiment 1 of the present invention;
FIG. 7 is a structural view of a variable-configuration spherical multi-electrode pulsed electric field ablation catheter in example 1 of the present invention;
FIG. 8 is an expanded view of a transformable lantern-shaped multi-electrode pulsed electric field ablation catheter in accordance with example 1 of the present invention;
FIG. 9 is a schematic view of a dilating array of a transformable lantern-shaped multi-electrode pulsed electric field ablation catheter in accordance with example 1 of the present invention;
fig. 10 is a schematic view of a tip-separated single-point pulsed electric field ablation catheter in accordance with embodiment 1 of the present invention;
fig. 11 is a schematic view of a tip-separated single-point pulsed electric field ablation catheter in accordance with embodiment 1 of the present invention;
fig. 12 is a schematic view of an annular multi-electrode pulsed electric field ablation catheter in embodiment 1 of the present invention;
fig. 13 is a schematic view of the distal end of the ring-shaped multi-electrode pulsed electric field ablation catheter in embodiment 1 of the present invention being stretched;
fig. 14 is a schematic view of a single-point pulsed electric field ablation catheter with an integrated tip in accordance with embodiment 1 of the present invention;
fig. 15 is a schematic view of a head-end integrated single-point pulsed electric field ablation catheter with a perfusion hole at the head end according to embodiment 1 of the present invention;
fig. 16 is a schematic view of the internal circulation of cold-cutting liquid of the head-end integrated single-point pulsed electric field ablation catheter in embodiment 1 of the present invention;
FIG. 17 is a schematic view of a variable configuration annular multi-electrode pulsed electric field ablation catheter in accordance with example 1 of the present invention;
fig. 18 is a schematic view of the distal end of a variable configuration annular multi-electrode pulsed electric field ablation catheter (with a guide wire) in accordance with example 1 of the present invention;
FIG. 19 is a schematic view of a pulsed electric field ablation catheter with helical electrodes according to example 1 of the present invention;
fig. 20 is a schematic head end view of a pulsed electric field ablation catheter with a helical electrode according to example 1 of the present invention;
FIG. 21 is a diagram of the predicted electric field effect range of the annular multi-electrode in accordance with embodiment 1 of the present invention;
FIG. 22 is a diagram of the electric field effect range of the single-point ablation catheter in accordance with example 1 of the present invention;
fig. 23 is a flowchart of a self-test module determination method in embodiment 1 of the present invention;
FIG. 24 is a graph showing the relationship between the electric field intensity and the pulse width as well as the ablation effect in example 1 of the present invention;
FIG. 25 is a table of electric field strength thresholds that can be tolerated by different tissues in example 1 of the present invention.
Detailed Description
The present invention will be described in further detail with reference to test examples and specific embodiments. It should be understood that the scope of the above-described subject matter is not limited to the following examples, and any techniques implemented based on the disclosure of the present invention are within the scope of the present invention.
Example 1
An integrated system for cardiac ablation comprises a pulsed electric field ablation device, a three-dimensional mapping system, an infusion pump, an ablation catheter and a radiofrequency instrument, and the system block diagram is shown in fig. 1.
The pulsed electric field ablation device is composed of a magnetic signal receiving module, a self-checking module, an impedance detection module, a pressure receiving module, a sensing module, a catheter identification module, a pulsed electric field generating module, an electric signal receiving module, a pre-pulse module and a switch switching matrix. The three-dimensional mapping system consists of a display operation module, an electrocardiosignal analysis and processing module, a magnetic signal analysis and processing module, a pressure analysis and processing module, a modeling navigation and electrophysiological module, a stimulation output module and an impedance analysis module. The perfusion pump is mainly composed of a perfusion control module. The radio frequency instrument consists of a temperature detection module and a radio frequency generation module.
The pulsed electric field ablation device, the three-dimensional mapping system, the perfusion pump and the radio frequency instrument realize data transmission and sharing through a data bus and communication modules of all parts so as to meet the requirement of cooperative work. The data transmission content mainly comprises magnetic signals, electrocardiosignals, pressure signals and impedance signals, and in addition, the magnetic signals, the electrocardiosignals, the pressure signals and the impedance signals can also be directly connected to the three-dimensional mapping system through a switch switching matrix, so that the signals can be timely fed back to the three-dimensional mapping system.
The ablation catheter is connected with the system through a catheter identification module in the pulsed electric field ablation device, signals collected by the ablation catheter are sent to the three-dimensional mapping system through the pulsed electric field ablation device, the three-dimensional mapping system processes the received signals and controls the pulsed electric field ablation device, a radio frequency signal output end of the radio frequency instrument is connected into a switch switching matrix of the pulsed electric field ablation device, and the three-dimensional mapping system realizes switching of pulsed electric field energy output and radio frequency energy output by controlling the switch switching matrix of the pulsed electric field ablation device.
All consumable catheters are connected to a pulsed electric field ablation device. The transmission of the radio frequency signal of the radio frequency instrument, the pulse signal of the pulse electric field generating module and the mapping signal of the three-dimensional mapping system is realized by the switching of the switch switching matrix. The connection relationship is shown in fig. 1, a radio frequency signal output by a radio frequency generation module in the radio frequency instrument is firstly output to a filtering module of a three-dimensional mapping system, clutter and interference are filtered out firstly, and then the radio frequency signal is output to a switch switching matrix of the pulsed electric field ablation device through the filtering module. The output end of a three-dimensional mapping module in the three-dimensional mapping system is connected with a switch switching matrix, the output of a calibration signal and the receiving of a calibration return signal are realized through the switch switching matrix, and a pulse signal output by a pulse electric field generating module is output to the switch switching matrix.
The switching of the switching matrix specifically includes:
(1) and (3) outputting radio frequency signals and acquiring data, wherein the switch switching matrix enables the electric signal receiving module, the pressure receiving module, the magnetic signal receiving module and the impedance detection module to be connected with the three-dimensional mapping system, and the signals are transmitted to the three-dimensional mapping system through a lead in real time. When the data are collected, the switch switching matrix is switched to a radio frequency output state, and radio frequency signals can be simultaneously output to the catheter. The RF meter can also detect the temperature of the catheter in real time.
(2) And (6) outputting the pulse. Since the voltage of the pulse output is usually 500V-5KV and the action time is short, the short-time high-voltage output can generate strong electromagnetic interference and insulation impact. Thus, to ensure proper use of the consumable catheter, RF and pulse applications are satisfied. When the switch switching matrix is switched to the pulse signal, the switch switching matrix simultaneously cuts off a path for connecting the three-dimensional mapping system and the ablation catheter, the path comprises an electric signal receiving module, a pressure receiving module, a magnetic signal receiving module and an impedance detection module, the three-dimensional mapping system is also cut off, the connection between the radio frequency signal and the ablation catheter is also cut off, and after the short-time pulse electric field energy is output, the original connection is recovered, so that the safety of the system in pulse application is ensured, and the anti-interference capability of the system is enhanced.
Fig. 2 shows a data interaction diagram of the three-dimensional mapping system and the pulsed electric field ablation device, wherein a catheter magnetic sensor, a catheter electrode and a catheter pressure sensor are arranged on an ablation catheter, sensor signals in the catheter and electrophysiological signals detected by the electrode are converted into transmittable signals through the catheter, and the signals are transmitted to the three-dimensional mapping system by taking the pulsed electric field ablation device as a medium. The data interaction between the pulsed electric field ablation device and the three-dimensional mapping system is mainly realized by the following steps and modules: a magnetic signal receiving module in the pulsed electric field ablation device sends a magnetic signal acquired from an ablation catheter to a magnetic signal analyzing and processing module in a three-dimensional mapping system; an electric signal receiving module in the pulsed electric field ablation device sends electrophysiological signals collected from an ablation catheter to an electrocardiosignal analyzing and processing module in a three-dimensional mapping system; and a pressure receiving module in the pulsed electric field ablation device transmits the pressure signal acquired from the ablation catheter to a pressure analyzing and processing module in the three-dimensional mapping system. The data communication between the modules can be directly connected or realized through the communication modules and the data bus.
After receiving the signals, the three-dimensional mapping system performs the following processing:
(1) the magnetic signal is used to determine the catheter position.
(2) The electrophysiological signals are used for recording the electrophysiological activities of the heart, so as to help doctors to judge focus points and to judge treatment effects.
(3) The pressure signal is used for knowing the action pressure of the current catheter, so that whether the action force of ablation is enough or not and whether the catheter is attached enough or not and whether the action force of the catheter is too large are judged, and when the action force is too large, an early warning is given out to prevent the catheter from propping through the heart.
(4) The communication modules can be realized through serial ports, networks and the like, remote operation is realized through a three-dimensional mapping system by adopting an autonomous protocol, and signals detected by the pulse and state data are transmitted by adopting the autonomous protocol.
The above sections mainly describe how the three-dimensional mapping system receives data acquired on the catheter through the pulsed electric field ablation device, and reflects the working state of the system in real time according to the received information. The three-dimensional mapping system further realizes the output of the pulse electric field energy or the radio frequency energy on the ablation catheter through the pulse electric field ablation device and the radio frequency instrument.
The three-dimensional mapping system can send a control command to the modeling navigation and electrophysiology module through the display operation module so as to detect the position of the electrode. Although the pulsed electric field ablation device can determine whether the impedance at the position can be distributed through the impedance detection module, if a plurality of catheters are used in the heart and other catheters are too close to the pulsed ablation catheter, if the pulse is output at the moment, the catheter and the connected equipment can be caused with adverse conditions, and at worst, the equipment and consumables can be damaged. The three-dimensional information of the ablation catheter can be obtained through the three-dimensional mapping system, the condition of the catheter around the cardiac pulse electric field ablation catheter is identified, and the safety of discharging is guaranteed. The modeling navigation and electrophysiological module of the three-dimensional mapping system has a position positioning function and realizes the visualization of position information, thereby ensuring the safety of the pulse ablation process.
Further, the three-dimensional mapping system can record the track of the ablation of the pulse ablation catheter and can record the electrophysiological changes before and after the ablation. The electrophysiological examination is carried out in a stimulation output mode through electrophysiological changes, and whether the pulse ablation process achieves the expected effect or not is judged according to electrophysiological examination data and the ablation track of the pulse ablation catheter.
Furthermore, the three-dimensional mapping system can judge whether the catheter is ideally attached through the pressure analysis of the pressure analysis processing module and the impedance analysis of the impedance analysis processing module, so that the pulse ablation can be effectively acted on tissues instead of blood, and the ablation effect is further ensured. When the adopted catheter is a single-point ablation catheter (as shown in fig. 10 and 11), the contact point of the catheter contacting with the tissue is single, the pressure analysis processing module carries out pressure analysis on the pressure value of the catheter abutting against the tissue, so that the abutting state of the catheter and the tissue can be obtained, and the abutting pressure of the catheter and the tissue is in a proper range when the ablation energy is output on the catheter by monitoring the abutting state. When the adopted catheter is a non-single-point ablation catheter (for example, the spherical multi-electrode ablation catheter in fig. 7, the lantern-shaped multi-electrode ablation catheter in fig. 8, and the annular multi-electrode ablation catheter in fig. 12), the number of points of contact between the catheter and the tissue is large, the catheter has different shapes, and the actual contact state of the catheter and the tissue cannot be reflected through pressure detection.
Further, the three-dimensional mapping system forms an AI Ablation Index (ablatioin Index) through the self-defined data transmitted by the pulsed electric field Ablation device, and the AI Index can be used as an evaluation of the Ablation effect, so that a doctor can be helped to judge the Ablation effect.
There are two modes of AI index, one is radio frequency mode and one is pulse mode. This parameter is simply a reference to the operator's ablation, and is a unitless parameter that may be analogous to a percentage of the volume.
Radio frequency mode: the RF power, RF temperature, impedance, ablation time, and contact pressure are integrated and fit to a parameter that varies with the RF power, RF temperature, impedance, ablation time, and contact pressure, and the typical parameter range is-1000 and 1000. When the parameter is between-50 and 200 during ablation, the ablation effect can reach the expected requirement of ablation depth.
The pulse mode is as follows: the applied pressure (used in single-point ablation catheters) is fit to a variable parameter, typically in the range of-1000 and 1000, based on pulse amplitude, impedance, and pulse effective time. When the parameter is between-50 and 200 during ablation, the ablation effect can reach the expected requirement of ablation depth.
Preferably, the impedance detection module in the pulsed electric field ablation device is specially designed. An impedance detection module in the pulsed electric field ablation device is used for realizing impedance detection of the catheter against tissues, and can be realized by three modes of time-sharing switching detection, fusion extraction detection and frequency-division switching detection, as shown in fig. 3. The impedance data can not only provide a pulse electric field ablation device for load protection and prevent the output of pulse energy in suspension and short circuit, but also can be transmitted to a three-dimensional mapping system to be used as a judgment basis for the attachment detection of the catheter.
When the impedance detection module of the pulsed electric field ablation device adopts a time-sharing switching detection mode, only one sampling circuit and one excitation circuit are used, the excitation and sampling circuit is loaded on the ablation catheter through an electrode channel switching switch, and each loop needing sampling is loaded and sampled in a time-sharing mode through the switching switch, so that the purpose of detection is achieved. The impedance time-sharing detection mode is specifically as shown in fig. 4, the electrode path change-over switch ensures that the detection signal with the unique frequency is only loaded on one electrode path at the same time, and other electrode paths are disconnected through the electrode path change-over switch.
When the impedance detection module of the pulsed electric field ablation device adopts a frequency division switching detection mode, n sampling circuits and n excitations are adopted, wherein n excitation signals can be staggered and cannot be overlapped, and only one excitation signal acts on an electrode at the same time. The sampling circuit extracts signals according to the self-sampling time to obtain the impedance value of the electrode loop. The structure of the impedance frequency division detection method is specifically as shown in fig. 5, each electrode of the impedance detection of frequency division switching has no switch, but only one electrode outputs a detection signal of the corresponding frequency at the same time. The impedance of all the electrodes in the detection method can be detected only by traversing the frequency of each electrode once, and the real-time performance is poor.
When the impedance detection module of the pulsed electric field ablation device adopts a fusion extraction detection mode, n sampling circuits are adopted and n excitations exist, but the n excitations are fused into one signal by a fusion method and are directly added to the catheter. The frequencies of the n excitation signals differ here. The n-path sampling circuit is provided with n signal extraction modules, and can extract and sample the uniform sampling signals according to the frequency of the signals of the corresponding paths, so that the impedance values of the corresponding electrode channels can be obtained. The structure of the fusion extraction detection circuit is specifically shown in fig. 6, and the fusion extraction is to output the detection frequencies of all the electrodes simultaneously and extract the detection frequencies simultaneously. The detection signals corresponding to the detection frequencies of different electrodes are extracted and distinguished in an analog or digital mode through signal filtering, so that impedance information corresponding to different electrodes is obtained.
The magnetic signal receiving module, the electric signal receiving module, the pressure receiving module and the impedance detecting module of the pulsed electric field ablation device can receive the electric signals, the magnetic signals, the pressure signals and the impedance signals of the catheter and transmit the electric signals, the magnetic signals, the pressure signals and the impedance signals to the three-dimensional mapping system through the communication module and the data bus, and the three-dimensional mapping system carries out analysis and processing through the electrocardiosignal analysis and processing module, the magnetic signal analysis and processing module, the pressure analysis and processing module and the impedance analysis and processing module to obtain electrophysiological information of a patient, position information of the catheter and the attaching state of the operating position of the catheter. And guiding the modeling navigation module to realize the establishment of a heart model, the navigation of the catheter and the update of the electrophysiological signal by using the information.
The three-dimensional mapping system can realize the output of the stimulation signal through the stimulation output module so as to measure the electrophysiological threshold of the ablation part as a judgment means of the ablation effect.
The pulsed electric field ablation device is provided with a sensing module and can receive electrocardiosignals of a specific channel as sensing synchronous signals, so that the timing for sending the pulsed electric field signals can be determined according to the synchronous signals, the output in the period of easy flutter is avoided, and the safety of treatment is ensured.
The pulsed electric field ablation device is provided with a catheter identification module, so that different types of cardiac pulse ablation catheters can be identified, and different parameter configurations, control characteristics and channel configurations can be further realized. Wherein the channel configuration may be realized by a switching matrix. Catheters that may be used with the integrated system include those shown in fig. 7-20. After presetting corresponding types and switching commands, the comprehensive system can be matched with the catheter through a catheter identification module of the pulsed electric field ablation device.
Some important parameters for the catheter are: the number of catheter electrodes, relevant parameters of the electrodes (electrode spacing and electrode width), the number of magnetic sensors, configuration parameters of the sensors, the type of the catheter (the range of the used pulse parameter setting which is the radio frequency ablation parameter is determined, and the catheter is particularly suitable for a single-point ablation catheter), whether the catheter has an irrigation function and the like.
Parameters for catheter identification are illustrated in table 1, taking a single-point pulsed electric field ablation catheter and a ring-shaped multi-pole pulsed ablation catheter as examples:
TABLE 1 Single-Point Impulse electric field ablation catheter and annular multipole Impulse ablation catheter identification parameters
The above information systems are read and identified when matching with catheters, and the functions and uses of the specific catheters are also distinguished as follows:
(1) a lantern, spherical, annular multi-electrode catheter can be modeled in real time in a three-dimensional mapping system through electrodes and magnetic sensors. Particularly when the catheter is squeezed during use, can also be displayed in real time. Therefore, the abnormal condition that the electrodes are too close due to extrusion can be directly found in real time, and the prompt can be directly carried out on the three-dimensional mapping system, so that the abnormal pulse output caused by too close output is avoided. When the catheter is used, pulse output of different electrode combinations can be realized through a switch switching matrix.
(2) A single-point ablation catheter may output both pulsed and radiofrequency energy. The temperature detection sensor is arranged and can transmit the temperature detection signal to the radio frequency instrument in real time. Some types of catheters of this type also have an irrigation function. The cooperation of the perfusion pump can realize perfusion ablation in a radio frequency mode and realize local cooling of the electrode in a pulse mode. Under the control of the perfusion control module, the three-dimensional mapping system obtains the real-time temperature of the ablation catheter through the temperature detection module in the radio frequency instrument, and when the real-time temperature exceeds a threshold value, the three-dimensional mapping system controls the cooling liquid to flow in the ablation catheter through the perfusion control module in the perfusion pump, so that the ablation catheter is cooled, or the perfusion liquid is controlled to flow out of micropores at the head end of the catheter, and an external electrode is cooled. When the real-time temperature does not exceed the threshold value, the three-dimensional mapping system controls the flow rate of the cooling liquid in the ablation catheter through an irrigation control module in the irrigation pump, or closes a flow switch to stop irrigation cooling.
In addition, when the conduits are matched, energy output is not needed, the range of the action of the irreversible perforating electric field intensity of the electrodes on the conduits can be estimated according to the electrode parameters of different conduits and preset pulse parameters (mainly pulse amplitude and pulse effective time), and when the action range exceeds the preset threshold range or is obviously improper, the system sends out an early warning signal, so that an operator can conveniently adjust the position and parameters of the conduits or change the type of the conduits. Further, the estimated range of the electric field intensity effect can be displayed on the three-dimensional mapping system in real time for visual display, and an operator can visually see the ranges of the electric field intensity effects of different types of catheters according to the visual image, as shown in fig. 21, when the catheter is a ring catheter, the electric field effect range is approximately in a ring shape formed by a plurality of spherical shapes, as shown in fig. 22, when the catheter is a single-point ablation catheter, the electric field effect range is approximately in a ring shape centered on the electrode. The electric field action range estimation function is realized during the matching of the guide pipes, so that the electric field action range can be estimated without waiting for energy output, the guide pipe matching efficiency is improved, the operation is more convenient, and the electric field action range provides reference for an operator. The range is displayed in real time in the three-dimensional mapping system, and can be automatically updated and changed according to the position, the action point and different setting parameters of the catheter.
As a preferable aspect of the present invention, the self-test module of the pulsed electric field ablation device is specially designed, and a flow chart of a determination method of the self-test module of the pulsed electric field ablation device is shown in fig. 23. The process mainly comprises the following steps:
s1, start pulse or pre-pulse;
s2, judging the load condition of the connection of the conduit, executing the step S3 when the load condition of the connection of the conduit is judged to be normal, otherwise, the system enters a safe state and gives an alarm;
s3, outputting internal prepulse, judging whether an internal switching tube and a detection circuit are normal, executing a step S4 when the internal switching tube and the detection circuit work normally, otherwise, enabling the system to enter a safety state and give an alarm;
and S4, the self-checking is successful, and the corresponding pulse output or pre-pulse function is started.
The output can be allowed under the condition that the conduit is connected with the load and the inside of the pulse electric field device is correct, and the output or the pre-pulse starting is carried out each time, so that the safety of the use of each pulse is ensured.
The system will predict the electric field effect range according to the set pulse parameters and the used conduit. As shown in fig. 21 and 22, the electric field ranges of the ring-shaped multi-electrode ablation catheter and the single-point ablation catheter are shown. The energy can be displayed in real time in the three-dimensional mapping system, so that an operator can judge an ablation area, the three-dimensional mapping system can display the electric field action range of the catheter in real time before energy (pulse energy or radio frequency energy) is output, reversible perforation or irreversible perforation of cells is realized after the energy is output, then the operator can compare the estimated electric field action range of the catheter with the actual electric field action range of the catheter, and if the consistency is better, the ablation operation is normal; if the consistency is not good, the deviation can be detected, and the cause of the deviation can be found according to the deviation.
The relationship between the electric field strength and the pulse width and the ablation effect is shown in fig. 24, the pulse width is used as the abscissa, the electric field strength is used as the ordinate, and the two-dimensional plane area constructed by the relationship can be divided into a reversible electroporation region, an irreversible electroporation region and a thermal injury region; under the action of the electric field intensity and the pulse width corresponding to the irreversible perforation area, the cells are perforated, and even if the electric field action is eliminated, the cells still keep the perforated state and cannot be recovered, so that irreversible electroporation is formed. The values of the electric field intensity and the pulse width corresponding to the thermal damage area are large, which can cause thermal damage to tissues in different degrees and need to be avoided.
FIG. 25 shows a table of electric field strength threshold values that can be borne by different tissue cells, where the lowest pressure threshold value for realizing irreversible puncturing by cardiomyocytes is 400V/cm; the lowest pressure threshold for realizing irreversible perforation of the myocardial cells is 1600V/cm; the lowest pressure threshold for realizing irreversible perforation of vascular smooth muscle cells is 1750V/cm; the lowest pressure threshold for realizing irreversible perforation by endothelial cells is 1750V/cm; the lowest pressure threshold value for realizing irreversible perforation of the nerve cells is 3800V/cm; reversible electroporation can be produced for each type of cell by applying an electric field strength to the tissue below the above-mentioned pressure threshold. This principle is the theoretical basis for the pre-pulse module. The pre-puncture function using the pre-pulse module is primarily used in conjunction with a three-dimensional mapping system. In the three-dimensional mapping system, the electrophysiological signals of the current catheter position can be known through the electric signals transmitted by the catheter, and the position can be reversibly perforated through a pre-perforation mode. So that its electrophysiological conduction changes. For some positions needing to block abnormal conduction, reversible blocking can be performed through pre-perforation, so that whether a blocking path acted on the point by pulses is correct or not can be known through the electrophysiology wave deformation of the position and even through the electrophysiology conduction test of a stimulation output module of a three-dimensional mapping system, and accurate positioning is achieved. Thus, the focal point can be effectively treated by pulse ablation. The ablation safety is greatly improved through the pre-perforation mode, and accidental injury to normal conducting cells is avoided.
Meanwhile, the pre-pulse module can also be used for testing the ablation effect. Before ablation, the lower parameters are passed, which are not in the areas of reversible electroporation, irreversible perforation, thermal injury. The current and even the impedance of the test output is output by this pulse. When the pulse is applied to generate irreversible perforation on the myocardial cells, different conductive ions in the myocardial cell membrane can flow out of the myocardial cell membrane due to the apoptosis of the myocardial cells, so that the conductivity outside the myocardial cell membrane is enhanced. Thus the current through the test with the pulse module will increase and the resistance will decrease, both parameters often corresponding to the electroporation effect. If the ablation of the myocardial cells in the region is successfully completed, the current and the resistance of the myocardial cells will not change obviously, because the myocardial cells to be ablated in the region can not be found any more. Therefore, the effect of pulse ablation can be indirectly judged through the change conditions of current and impedance in the judgment of the previous and next ablation tests.
Except for the output mode of the pre-pulse, the system also has a pre-output mode, when the system is pre-output, the system works inside, the energy is not output to the human tissue through the catheter, and the whole pulse output process can be confirmed once. The first is whether the external resistor is properly short-circuited or open-circuited. Secondly, due to the pre-output, the accuracy of the detection circuit of the internal circuit and the pulse output circuit can be verified, such as the pulse amplitude, the pulse width, and the time characteristic of the pulse waveform. Whether the devices in the phase-changeable verification pulse system can work in a normal state or not is verified. Only after the verification is passed, the real pulse output can be carried out, and the correctness and the safety of the system when the pulse ablation is carried out are ensured.
In practical application, different parameters, such as different electric field strengths and different pulse widths, can be used according to different ablation positions. This can meet the requirements of different ablation depths. However, the larger electric field strength and the larger pulse width may cause thermal damage, which needs to be avoided to the utmost. The thermal damage is caused in part by the local high temperature generated in the catheter due to the excessive energy of the pulsed electric field. For this purpose, an infusion pump is introduced, which is controlled to produce different infusion flow rates depending on different parameters. The perfusion cooling effect of the perfusion pump can act in the internal circulation conduit or the external perfusion conduit. Thereby playing the role of local cooling. Therefore, the ablation parameters can be improved to a certain degree of safety, and the purpose of improving the ablation depth is achieved.
Through the functions of all modules described in the pulse ablation system consisting of the pulse electric field ablation device, the three-dimensional mapping system, the radio frequency instrument and the perfusion pump, different types of pulse electric field ablation catheters can be used in a matched manner according to different using modes, so that the catheter is used for different surgical procedures.
While there have been shown and described what are at present considered the fundamental principles and essential features of the invention and its advantages, it will be apparent to those skilled in the art that the invention can be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.
Furthermore, it should be understood that although the present description refers to embodiments, the embodiments do not include only one independent technical solution, and such description is only for clarity, and those skilled in the art should take the description as a whole, and the technical solutions in the embodiments may be appropriately combined to form other embodiments that can be understood by those skilled in the art.
Claims (12)
1. An integrated system for cardiac ablation, which is characterized by comprising a pulsed electric field ablation device, a three-dimensional mapping system, a radiofrequency instrument and an ablation catheter,
the pulsed electric field ablation device comprises a pulsed electric field generating module, wherein the pulsed electric field generating module is used for outputting a pulsed electric field signal to the ablation catheter; the pulsed electric field ablation device further comprises a magnetic signal receiving module, an electric signal receiving module, a pressure receiving module and an impedance detection module, the magnetic signal, the electrocardiosignal, the pressure signal and the impedance signal are respectively received through the ablation catheter, and the magnetic signal, the electrocardiosignal, the pressure signal and the impedance signal are transmitted to the three-dimensional mapping system; the pulsed electric field ablation device also receives a calibration signal output by the three-dimensional mapping module, outputs the calibration signal to the ablation catheter and outputs a calibration return signal to the three-dimensional mapping system;
the three-dimensional mapping system comprises a three-dimensional mapping module, a magnetic signal analysis and processing module, an electrocardiosignal analysis and processing module, a pressure analysis and processing module, an impedance analysis and processing module and a modeling navigation and electrophysiological module, wherein the three-dimensional mapping module realizes the calibration of the ablation catheter according to a calibration return signal obtained from the pulsed electric field ablation device; the three-dimensional mapping system further analyzes and processes the magnetic signal, the electrocardiosignal, the pressure signal and the impedance signal respectively to obtain position information of the catheter, electrophysiological information of the patient and the attaching state of the catheter operation position, and the three-dimensional mapping system further realizes the establishment of a heart model and the navigation of the ablation catheter by a modeling navigation and electrophysiological module by taking the position information of the catheter as guidance; the three-dimensional mapping system is further used for controlling the switching between the pulsed electric field signal and the filtered radio frequency ablation signal;
the radio frequency instrument is used for outputting a radio frequency ablation signal to a filtering module of the three-dimensional mapping system to filter interference and outputting the filtered radio frequency ablation signal to the pulsed electric field ablation device;
the ablation catheter is connected with the pulsed electric field ablation device, is used for outputting the pulsed electric field signal or the filtered radio frequency ablation signal, acquiring the magnetic signal, the electrocardiosignal, the pressure signal and the impedance signal, and outputting the magnetic signal, the electrocardiosignal, the pressure signal and the impedance signal to the pulsed electric field ablation device, and is also used for returning a calibration return signal to the pulsed electric field ablation device according to the calibration signal.
2. The integrated system for cardiac ablation according to claim 1, further comprising a switching matrix, wherein the pulsed electric field ablation device is switched to output the pulsed electric field signal or the filtered rf ablation signal to the ablation catheter, and the magnetic signal, the ecg signal, the pressure signal, the impedance signal, and the calibration return signal are further acquired through switching of the switching matrix.
3. An integrated system for cardiac ablation according to claim 2, wherein under the switching control of the switching matrix, when the pulsed electric field signal is output in the ablation catheter, the transmission channels of the magnetic signal, the electrocardiosignal, the pressure signal, the impedance signal and the calibration return signal are cut off; when the radiofrequency ablation signal is output in the ablation catheter, the magnetic signal, the electrocardiosignal, the pressure signal, the impedance signal and the calibration return signal are transmitted simultaneously.
4. An integrated system for cardiac ablation according to claim 1, wherein the impedance detection module detects the attachment state of the operative catheter position by time-division switching detection, fusion extraction detection, and frequency-division switching detection.
5. The integrated system for cardiac ablation according to claim 4, wherein when the impedance detection module employs a time-division switching detection mode, the sampling circuit and the excitation are connected to the catheter through the electrode channel switch, the excitation signal and the sampling signal of the sampling circuit are loaded to the corresponding catheter through the electrode channel switch, and the impedance value of the electrode loop of the ablation catheter is obtained by loading the excitation signal and obtaining the sampling signal through the time-division switching of the electrode channel switch.
6. An integrated system for cardiac ablation according to claim 4, wherein the impedance detection module employs n sampling circuits and n excitations respectively connected to the catheter when the frequency division switching detection mode is adopted, and only one excitation signal is applied to the catheter at the same time, and the sampling circuits obtain the impedance value of the electrode loop of the catheter according to their own sampling frequency.
7. The integrated system for cardiac ablation according to claim 4, wherein when the impedance detection module adopts a fusion extraction detection mode, n sampling circuits and n excitations are used, wherein the n excitations are connected with the catheter through the excitation fusion module, the n sampling circuits are respectively connected with the catheter through the signal extraction module, the excitation signals corresponding to the n excitations are different, and the n sampling circuits respectively obtain the impedance value of the electrode loop corresponding to the catheter through the signal extraction module.
8. The integrated system for cardiac ablation according to claim 1, wherein the filtering module is further configured to filter the cardiac signal output by the electrical signal receiving module and output the filtered cardiac signal to the cardiac signal analyzing and processing module.
9. An integrated system for cardiac ablation according to claim 1, wherein the pulsed electric field ablation device further comprises a catheter identification module for identifying different types of cardiac pulse ablation catheters and implementing parameter configurations, control feature configurations and channel configurations of the different types of cardiac pulse ablation catheters, wherein the channel configurations are implemented by a switching matrix.
10. An integrated system for cardiac ablation according to claim 1, wherein the pulsed electric field ablation device further comprises a self-test module, the workflow of which comprises the steps of:
s1, start pulse or pre-pulse;
s2, judging the load condition of the connection of the conduit, executing the step S3 when the load condition of the connection of the conduit is judged to be normal, otherwise, entering a safety state and alarming;
s3, outputting internal prepulse, judging whether an internal switching tube and a detection circuit are normal, executing the step S4 when the internal switching tube and the detection circuit work normally, and otherwise, entering a safety state and giving an alarm;
and S4, the self-checking is successful, and the corresponding pulse output or pre-pulse function is started.
11. An integrated system for cardiac ablation according to claim 1, wherein the pulsed electric field ablation device further comprises a pre-pulse module, said pre-pulse module operating in a pre-puncture mode or a pre-test mode, said pre-pulse module controlling output parameters such that the cardiomyocytes undergo reversible puncture; in a pretest mode, the pre-pulse module measures electrical parameters before and after ablation, and determines the pulse electric field ablation effect by comparing the variation of the electrical parameters before and after ablation.
12. An integrated system for cardiac ablation according to any of claims 1-11, further comprising an infusion pump including an infusion control module for controlling cooling fluid flow through the cardiac pulsed electric field ablation catheter for reducing localized hyperthermia produced on the catheter.
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