Real-time feedback pulse ablation system

Abstract

The invention provides a real-time feedback pulse ablation system. The system comprises a power supply module; the human-computer interaction interface is used for displaying information fed back by the main control module; the high-voltage pulse module outputs a high-voltage pulse signal to the ablation instrument through the switching module; the impedance detection module is used for detecting impedance information of a target position to the ablation instrument through the switching module; the temperature detection module is used for detecting the temperature of the ablation instrument in real time through the switching module; the main control module controls switching of different functional modules; the main control module is used for displaying the data on a human-computer interaction interface; the electrical stimulation module simulates and outputs sine waves, square waves, triangular waves and other signals to the ablation instrument; the signal acquisition module is used for directionally acquiring signals through an electrode at the other end of the ablation instrument; an ablation instrument; according to the real-time feedback pulse ablation system, control over ablation tissue is improved, the ablation process is effectively monitored, and safety and reliability of the operation process are guaranteed.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a real-time feedback pulse ablation system. Background Art

[0002] In the prior art, the Maze IV procedure is generally performed using radiofrequency therapy to treat atrial fibrillation. Radiofrequency therapy kills myocardial cells by maintaining a temperature of 65-100°C for a certain period of time, achieving isolation and forming ablation lines. However, the range of radiofrequency ablation is uncontrollable and can easily cause thrombosis or damage other normal tissues and blood vessels.

[0003] In addition, when performing the Maze IV procedure, whether it is a minimally invasive or surgical approach, there is no way to monitor the effectiveness of the ablation in real time, especially when using a surgical approach, which cannot be verified by electrocardiogram.

[0004] Therefore, how to improve the control of ablated tissue and effectively monitor the ablation process becomes the key technical problem to be solved in this solution. Summary of the invention

[0005] The purpose of the present invention is to provide a real-time feedback pulse ablation system, which solves the technical problem of how to improve the control of ablated tissue and effectively monitor the ablation process. The present solution provides a controller or "matrix router" that can control the transmission of RF energy and other electrical signals to the ablation instrument, which provides a unique and non-obvious improvement over existing devices and systems, and provides unique practicality that was previously unknown or not obvious, improves the control and efficiency of ablated tissue, enhances sensing and pacing capabilities, and ensures the safety and reliability of the surgical process.

[0006] A real-time feedback pulse ablation system includes a power supply module, a high-voltage pulse generation module, an electrical stimulation module, a pulse ablation device, a switching module, and a main control module; wherein:

[0007] The power supply module is electrically connected to the high-voltage pulse generating module, the impedance detecting module, and the temperature detecting module, and is used for supplying energy to the modules;

[0008] The high-voltage pulse generating module is configured to send a high-voltage pulse signal to the pulse ablation device;

[0009] The electrical stimulation module outputs analog output signals such as sine waves, square waves and triangle waves to the outer electrodes of the paired working electrodes of the ablation device;

[0010] The pulse ablation device comprises a plurality of ablation electrodes, the ablation electrodes comprising an outer electrode and an inner electrode, at least some of the ablation electrodes being configured as working electrodes for receiving high voltage pulse signals and performing ablation treatment on target tissues;

[0011] The switching module is connected to the main control module and switches to different functional modules. It is configured to receive the high-voltage pulse signal sent by the high-voltage pulse generating module under the control of the main control module, and select the working electrode and switch the positive and negative electrodes.

[0012] The main control module: displays data on the human-computer interaction interface through serial communication, collects information from different functional modules, controls the switching module, records data from the detection module and the temperature module, can set and excite the high-voltage pulse module, and is configured to receive impedance values ​​and evaluate the degree of contact between the working electrode and the target tissue;

[0013] At least one of the paired ablation electrodes is the outer electrode.

[0014] The outer electrode is disposed close to the distal end of the electrode carrier, the inner electrode is disposed close to the proximal end of the electrode carrier, and the paired ablation electrodes are the inner electrode and / or the outer electrode.

[0015] The pulse ablation device also includes a tip electrode, wherein the tip electrode and the outer electrode are configured as a paired ablation electrode.

[0016] The outer electrodes on the same electrode carrier are divided into an outer electrode group, and the end electrodes are paired with the outer electrode group in turn to detect the impedance value between the end electrodes and the outer electrodes.

[0017] The pulse ablation system also includes an impedance detection module, which detects the impedance information of the target position to the pulse ablation device through a switching module, evaluates the degree of contact and ablation, and is configured to select paired ablation electrodes and detect the impedance value between the paired ablation electrodes, at least one of the paired ablation electrodes is a working electrode.

[0018] The initial impedance value is detected before the working electrode is in contact with the target tissue.

[0019] The impedance detection module also includes a first multi-way selection switch, which includes a plurality of first selection switches corresponding one-to-one to and electrically connected to the ablation electrodes. The first selection switches are configured to be selectively opened or closed under the control of the main control module to electrically connect the impedance detection module with the corresponding paired ablation electrodes.

[0020] The pulse ablation system also includes a signal acquisition module, which directionally acquires signals through the inner electrodes of the ablation device, feeds back the collected information to the main control module in real time, and displays the waveform in the human-computer interaction interface to determine whether the ablation treatment is effective.

[0021] The pulse ablation system also includes a temperature detection module, which detects the temperature of the ablation device in real time through the switching module and feeds back to the main control module in real time to avoid damage caused by excessive temperature during the ablation process.

[0022] The switching module includes a first layer combination switch, a second layer combination switch and a third layer combination switch; wherein,

[0023] The input ends of the first layer combination switch are electrically connected to the positive and negative electrodes of the high voltage pulse signal output respectively;

[0024] The input ends of the second layer combination switch are respectively switchably connected to the output ends of the first layer combination switch, and the second layer combination switch is configured to perform the switching of the positive and negative poles under the control of the main control module;

[0025] The third-layer combination switch includes multiple ablation selection switches corresponding to the ablation electrodes one by one. The input end of the ablation selection switch is electrically connected to the second-layer combination switch, and the output end of the ablation selection switch is electrically connected to the corresponding ablation electrode. The third-layer combination switch is configured to select the working electrode and the positive and negative of each working electrode under the control of the main control module.

[0026] The main control module is further configured to control the high voltage pulse generation module to perform pre-discharge according to the discharge mode. The pulse ablation system further includes:

[0027] The diagnosis module is electrically connected to the signal acquisition module and the main control module, and is configured to determine whether the discharge of the working electrode is normal based on the collected current and voltage data, and feed back to the main control module.

[0028] The beneficial effects of the present invention are as follows:

[0029] (1) An impedance detection module is provided to detect the impedance information of the target position through a switching module to the ablation device to evaluate the degree of adhesion and ablation;

[0030] (2) Main control module: displays data on the human-computer interaction interface through serial communication, collects information from different functional modules, controls the switching module, records data from the detection module and temperature module, and can set and excite the high-voltage pulse module;

[0031] (3) It is equipped with a high-voltage pulse module, which can realize microsecond-level, high-voltage and high-frequency pulses, and has multiple over-current protection and over-voltage protection. It samples the current voltage in real time and compares it with the target parameter. At the same time, the over-voltage threshold and over-current threshold are set internally, and the output can be monitored in real time when the entire system is working. When the current or voltage exceeds its corresponding threshold, the output is locked, and an over-current alarm is sent to the human-computer interaction interface through the main control module. At the same time, the main control module closes the output channel after sending an interrupt signal in the first time, thereby improving safety performance;

[0032] The output microsecond and nanosecond high-voltage and high-frequency pulses can achieve precise targeted treatment, ablate the target lesions through the pulsed electric field with non-thermal effect, and adjust the electric field strength through different output parameters to avoid additional tissue damage and complications, greatly improving the effectiveness of treatment;

[0033] (4) This solution is a real-time feedback pulse ablation system that can verify the ablation effect after ablation. The effectiveness of pulse ablation can be verified through electrical stimulation and signal acquisition functions. Whether in the surgical or internal medicine use scenarios of Maze IV, this solution can verify the effectiveness after ablation. In the surgical use scenario, it is not necessary to wait until the heart beats again after the operation is completed to verify the surgical effect. The surgical effect can be verified during the operation.

[0034] (5) The present invention relates to the field of medical device technology, and more particularly to a pulse ablation system for pulsed electric field ablation, which is a new treatment technology for the treatment of atrial fibrillation. It utilizes an electrode device to form a local high electric field for tissue ablation, which can cause irreversible perforations of a few nanometers to several microns on the cell membrane to achieve precise, safe and efficient treatment effects. It does not produce thermal effects, does not damage normal tissues, and has a short treatment time. It can be applied to the Maze IV procedure for the treatment of atrial fibrillation. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 It is a connection diagram of the ablation system modules in the present invention.

[0036] Figure 2 This is a logic flow chart of the operation of the ablation system module in the present invention.

[0037] Figure 3 Schematic diagram of the functional composition of the ablation system module in the present invention.

[0038] Among them, the accompanying drawings are marked as: 1. power module; 2. human-computer interaction interface; 3. high-voltage pulse module; 4. impedance detection module; 5. temperature detection module; 6. switching module; 7. main control module; 8. electrical stimulation module; 9. signal acquisition module; 10. ablation device. DETAILED DESCRIPTION

[0039] In order to more clearly illustrate the technical features of this solution, this solution is described below through specific implementation methods.

[0040] See also Figure 1-Figure 3 A real-time feedback pulse ablation system includes a power supply module 1, a high-voltage pulse generation module, an electrical stimulation module 8, a pulse ablation device 10, a switching module 6, and a main control module 7; wherein,

[0041] The power supply module 1 is electrically connected to the high voltage pulse generating module, the impedance detecting module 4 and the temperature detecting module 5, and is used for supplying energy to the module;

[0042] A high-voltage pulse generating module, configured to send a high-voltage pulse signal to the pulse ablation device 10;

[0043] The electrical stimulation module 8 outputs analog output signals such as sine waves, square waves and triangle waves to the outer electrodes of the paired working electrodes of the ablation device 10;

[0044] The pulse ablation device 10 comprises a plurality of ablation electrodes, wherein the ablation electrodes comprise an outer electrode and an inner electrode, and at least some of the ablation electrodes are configured as working electrodes for receiving high voltage pulse signals and performing ablation treatment on target tissues;

[0045] The switching module 6 is connected to the main control module 7 and switches to different functional modules. The switching module 6 is configured to receive the high-voltage pulse signal sent by the high-voltage pulse generating module under the control of the main control module 7, and select the working electrode and switch the positive and negative electrodes.

[0046] Main control module 7: displays data on the human-machine interface 2 through serial communication, collects information from different functional modules, controls the switching module 6, records data from the detection module and the temperature module, can set and excite the high-voltage pulse module 3, and is configured to receive impedance values ​​and evaluate the degree of contact between the working electrode and the target tissue;

[0047] At least one of the paired ablation electrodes is an outer electrode.

[0048] The outer electrode is disposed near the distal end of the electrode carrier, the inner electrode is disposed near the proximal end of the electrode carrier, and the paired ablation electrodes are the inner electrode and / or the outer electrode.

[0049] The pulse ablation device 10 further includes a tip electrode, and the tip electrode and the outer electrode are configured as a paired ablation electrode.

[0050] The outer electrodes on the same electrode carrier are divided into an outer electrode group, and the end electrodes are paired with the outer electrode group in turn to detect the impedance value between the end electrodes and the outer electrodes.

[0051] The pulse ablation system also includes an impedance detection module 4, which detects the impedance information of the target position to the pulse ablation device 10 through a switching module 6, evaluates the degree of contact and ablation, and is configured to select paired ablation electrodes and detect the impedance value between the paired ablation electrodes, at least one of the paired ablation electrodes being a working electrode.

[0052] The initial impedance value is detected before the working electrode is placed against the target tissue.

[0053] The impedance detection module 4 also includes a first multi-way selection switch, which includes multiple first selection switches corresponding to and electrically connected to the ablation electrodes one by one. The first selection switches are configured to be selectively opened or closed under the control of the main control module 7 to electrically connect the impedance detection module 4 with the corresponding paired ablation electrodes.

[0054] The pulse ablation system also includes a signal acquisition module 9, which directionally acquires signals through the inner electrodes of the ablation device 10, feeds back the collected information to the main control module 7 in real time, and displays the waveform in the human-computer interaction interface 2 to determine whether the ablation treatment is effective.

[0055] The pulse ablation system also includes a temperature detection module 5, which detects the temperature of the ablation device 10 in real time through the switching module 6, and feeds back to the main control module 7 in real time to avoid damage caused by excessive temperature during the ablation process.

[0056] The switching module 6 includes a first layer combination switch, a second layer combination switch and a third layer combination switch; wherein,

[0057] The input ends of the first layer combination switch are electrically connected to the positive and negative electrodes of the high voltage pulse signal output respectively;

[0058] The input ends of the second layer combination switch can be respectively switchably connected to the output ends of the first layer combination switch, and the second layer combination switch is configured to perform positive and negative polarity switching under the control of the main control module 7;

[0059] The third layer combination switch includes multiple ablation selection switches corresponding to the ablation electrodes one by one. The input end of the ablation selection switch is electrically connected to the second layer combination switch, and the output end of the ablation selection switch is electrically connected to the corresponding ablation electrode. The third layer combination switch is configured to select the working electrode and the positive and negative of each working electrode under the control of the main control module 7.

[0060] The main control module 7 is also configured to control the high voltage pulse generation module to perform pre-discharge according to the discharge mode. The pulse ablation system also includes:

[0061] The diagnosis module is electrically connected to the signal acquisition module 9 and the main control module 7 , and is configured to determine whether the discharge of the working electrode is normal based on the collected current and voltage data, and feed back to the main control module 7 .

[0062] The specific working process of the present invention is:

[0063] This patent consists of 10 parts:

[0064] Power module 1: provides energy for human-machine interface 2, high-voltage pulse module 3, impedance detection module 4, and temperature detection module 5;

[0065] Human-machine interaction interface 2: can display the information fed back by the main control module 7 through serial communication, including temperature information, impedance detection information, dielectric detection information, treatment times and treatment positions, and can also control the main control module 7 to adjust parameters, perform treatments and switch modules through serial communication;

[0066] High-voltage pulse module 3: outputs high-voltage pulse signals to ablation device 10 through switching module 6;

[0067] Impedance detection module 4: detects impedance information of the target position to the ablation device 10 through the switching module 6, and evaluates the degree of adhesion and ablation;

[0068] Temperature detection module 5: detects the temperature of the ablation device 10 in real time through the switching module 6, and feeds back to the main control module 7 in real time, so as to avoid damage caused by excessive temperature during the ablation process;

[0069] Switching module 6: switches different functional modules through the control of main control module 7;

[0070] Main control module 7: displays data on the human-machine interaction interface 2 through serial communication, collects information from different functional modules, controls the switching module 6, records data from the detection module and the temperature module, and can set and excite the high-voltage pulse module 3;

[0071] Electrical stimulation module 8: can simulate and output sine wave, square wave, triangle wave and other signals to the ablation device 10;

[0072] Signal acquisition module 9: can collect signals through the electrode at the other end of the ablation device 10, and feed back the collected information to the main control module 7 in real time, and can display the waveform in the human-computer interaction interface 2;

[0073] Ablation device 10: connected to the device, it can perform pulse ablation treatment, effectiveness detection, impedance detection and temperature detection. There are ablation devices 10 of different specifications for surgical and medical procedures for the treatment of atrial fibrillation; communication methods include: RS485, RS232, RS422, SPI, TTL communication.

[0074] The specific implementation process is as follows:

[0075] This system can perform targeted pulse ablation treatment for atrial fibrillation through surgical or minimally invasive surgery; the main control module 7 is the core component, which controls each functional module in the system and can display the collected information and data in the human-computer interaction interface 2; during the entire treatment process, the main control module 7 can control the switching module 6 to switch different functions through serial communication; the ablation device 10 can determine the degree of contact of the ablation device 10 in real time through the impedance detection module 4; after confirming that it is completely in contact, switch to the high-voltage pulse module 3 to send a high-voltage pulse signal to the pulse ablation device 10 to achieve targeted treatment; while sending the high-voltage pulse signal, the temperature data of the part in contact with the patient will be detected in real time, and the temperature detection module 5 will give priority to processing and analysis to ensure whether the temperature in the device is at a normal level, and send the temperature information to the main control module 7 in real time for processing and display in the human-computer interaction interface 2;

[0076] When the temperature exceeds the threshold, the information will be fed back to the main control module 7 and an early warning will be issued through the human-computer interaction interface 2. When the temperature exceeds the threshold to a certain extent, the main control module 7 will actively send a signal to the high-voltage pulse module 3 to stop the treatment;

[0077] After the pulse ablation of a target tissue site is completed, an electrical signal is sent out through the electrical stimulation module 8, and the information fed back to the main control module 7 by the signal acquisition module 9 is observed in the human-machine interaction interface 2 to show whether a corresponding electrical signal is collected; if there is no corresponding electrical signal, the ablation of this target site is completed, and the ablation of the next target site can be carried out; if an electrical signal is collected, the process of 4-7 needs to be repeated;

[0078] The present invention is directed to the Maze IV procedure, including surgical methods and minimally invasive methods. During the operation, pulse ablation treatment is performed sequentially on the ablation target area.

[0079] Technical features not described in the present invention can be achieved through or by adopting existing technologies and will not be described in detail here. Of course, the above description is not a limitation of the present invention, and the present invention is not limited to the above examples. Changes, modifications, additions or substitutions made by ordinary technicians in this technical field within the essential scope of the present invention should also fall within the scope of protection of the present invention.

Claims

1. A real-time feedback pulse ablation system, characterized in that: It comprises a power supply module (1), a high-voltage pulse generation module, an electrical stimulation module (8), a pulse ablation device (10), a switching module (6), and a main control module (7); wherein: The power supply module (1) is electrically connected to the high-voltage pulse generating module, the impedance detecting module (4) and the temperature detecting module (5) and is used for supplying energy to the modules; The high-voltage pulse generating module is configured to send a high-voltage pulse signal to the pulse ablation device (10); The electrical stimulation module (8) outputs analog output signals such as sine waves, square waves and triangle waves to the outer electrodes of the paired working electrodes of the ablation device (10); The pulse ablation device (10) comprises a plurality of ablation electrodes, the ablation electrodes comprising an outer electrode and an inner electrode, at least some of the ablation electrodes being configured as working electrodes for receiving high voltage pulse signals and performing ablation treatment on target tissues; The switching module (6) is connected to the main control module (7) for switching to different functional modules, and is configured to receive the high-voltage pulse signal sent by the high-voltage pulse generating module under the control of the main control module (7), and to select the working electrode and switch the positive and negative electrodes; The main control module (7) displays data on the human-machine interaction interface (2) through serial communication, collects information from different functional modules, controls the switching module (6), records data from the detection module and the temperature module, can set and stimulate the high-voltage pulse module (3), and is configured to receive impedance values ​​and evaluate the degree of contact between the working electrode and the target tissue.

2. A real-time feedback pulse ablation system according to claim 1, characterized in that: At least one of the paired ablation electrodes is the outer electrode.

3. A real-time feedback pulse ablation system according to claim 1, characterized in that: The outer electrode is disposed close to the distal end of the electrode carrier, the inner electrode is disposed close to the proximal end of the electrode carrier, and the paired ablation electrodes are the inner electrode and / or the outer electrode.

4. A real-time feedback pulse ablation system according to claim 1 or 2, characterized in that: The pulse ablation device (10) further comprises an end electrode, wherein the end electrode and the outer electrode are configured as a paired ablation electrode.

5. A real-time feedback pulse ablation system according to claim 4, characterized in that: The outer electrodes on the same electrode carrier are divided into an outer electrode group, and the end electrodes are paired with the outer electrode group in turn to detect the impedance value between the end electrodes and the outer electrodes.

6. A real-time feedback pulse ablation system according to any one of claims 1 to 5, characterized in that: The pulse ablation system also includes an impedance detection module (4) which detects impedance information of the target position to the pulse ablation device (10) through a switching module (6), evaluates the degree of contact and the degree of ablation, and is configured to select paired ablation electrodes and detect the impedance value between the paired ablation electrodes, at least one of the paired ablation electrodes being a working electrode.

7. A real-time feedback pulse ablation system according to claim 6, characterized in that: The initial impedance value is detected before the working electrode is in contact with the target tissue.

8. A real-time feedback pulse ablation system according to any one of claims 1-3, 5, and 7, characterized in that: The impedance detection module (4) also includes a first multi-way selection switch, which includes a plurality of first selection switches corresponding one-to-one to and electrically connected to the ablation electrodes. The first selection switches are configured to be selectively opened or closed under the control of the main control module (7) so that the impedance detection module (4) is electrically connected to the corresponding paired ablation electrodes.

9. A real-time feedback pulse ablation system according to any one of claims 1-3, 5, and 7, characterized in that: The pulse ablation system also includes a signal acquisition module (9) that directionally acquires signals through the inner electrodes of the ablation device (10), feeds back the collected information to the main control module (7) in real time, and displays the waveform in the human-computer interaction interface (2) to determine whether the ablation treatment is effective.

10. A real-time feedback pulse ablation system according to any one of claims 1-3, 5, and 7, characterized in that: The pulse ablation system also includes a temperature detection module (5) which detects the temperature of the ablation device (10) in real time through a switching module (6) and feeds back to the main control module (7) in real time to avoid damage caused by excessive temperature during the ablation process.

11. A real-time feedback pulse ablation system according to claim 10, characterized in that: The switching module (6) comprises a first layer combination switch, a second layer combination switch and a third layer combination switch; wherein: The input ends of the first layer combination switch are electrically connected to the positive and negative electrodes of the high voltage pulse signal output respectively; The input ends of the second layer combination switch are respectively switchably connected to the output ends of the first layer combination switch, and the second layer combination switch is configured to perform the switching of the positive and negative poles under the control of the main control module (7); The third layer combination switch comprises a plurality of ablation selection switches corresponding one to one with the ablation electrodes, the input end of the ablation selection switch is electrically connected to the second layer combination switch, the output end of the ablation selection switch is electrically connected to the corresponding ablation electrode, and the third layer combination switch is configured to select the working electrode and the positive and negative of each working electrode under the control of the main control module (7).

12. A real-time feedback pulse ablation system according to any one of claims 1-3 and 5, characterized in that: The main control module (7) is further configured to control the high-voltage pulse generation module to perform pre-discharge according to a discharge mode, and the pulse ablation system further comprises: The diagnostic module is electrically connected to the signal acquisition module (9) and the main control module (7), and is configured to determine whether the discharge of the working electrode is normal based on the collected current and voltage data, and to feed back to the main control module (7).

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