Cardiac ablation pulsed electric field control device, control method and operation method

Abstract

The present invention belongs to the technical field of medical devices, and particularly relates to a cardiac ablation pulsed electric field control device, a control method and an operation method. Among them, the cardiac ablation pulsed electric field control device includes a pulse generator and an electrode connected to each other; the electrode includes: a catheter electrode with a ring electrode at the distal end, which is connected to the positive electrode of the pulse generator. A body surface electrode, which is a strip-shaped electrode and is connected to the negative electrode of the pulse generator. The present invention adopts two groups of electrodes, namely a body surface electrode and a catheter electrode, to improve the penetration depth of the pulsed electric field and the efficiency of electroporation.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a cardiac ablation pulsed electric field control device, a control method and an operation method. Background Art

[0002] Atrial fibrillation is a persistent arrhythmia phenomenon, which is caused by abnormal atrial electrophysiological functions. Pulmonary vein electrical isolation is a two-way electrical conduction block technology acting between the pulmonary veins and the atrium of the heart, and is the cornerstone of all ablation procedures. Current atrial fibrillation guidelines and expert consensus both recommend using it as the primary strategy for atrial fibrillation ablation, and radiofrequency ablation and balloon cryoablation are the two most commonly used ablation methods. The limitations of this heat-based ablation method include the lack of selectivity in damaging the tissue in the ablation area and the dependence on the catheter contact force, which may cause damage to adjacent esophagus, coronary artery, phrenic nerve, etc.

[0003] Pulsed electric field ablation uses electric field energy to instantaneously form irreversible micropores on the cell membrane, causing apoptosis of cells, achieving the purpose of non-thermal ablation, and is also known as irreversible electroporation. Since the thresholds of different tissues are different, under the condition of the same pulse, the injury thresholds of tissues and organs such as blood vessels, nerves, and esophagus are 4 times higher than that of myocardial cells. The advantages of this ablation based on electric field energy are as follows: (1) Strong selectivity, without damaging important structures such as coronary arteries, esophagus, and extracellular matrix. (2) The boundary between the ablation area and the non-ablation area is clear. (3) Fast ablation speed, and low requirement for catheter contact with the tissue.

[0004] Existing devices for treating arrhythmia with pulsed electric fields cannot achieve the above advantages of pulsed electric field ablation. Summary of the Invention

[0005] Aiming at the technical problem in the prior art that there is a lack of a device that can achieve the advantages of pulsed electric field ablation, the purpose of the present invention is to provide a cardiac ablation pulsed electric field control device, a control method and an operation method.

[0006] A cardiac ablation pulsed electric field control device includes a pulse generator and an electrode connected to each other;

[0007] The electrode includes:

[0008] A catheter electrode, the distal end of which is a ring electrode and is connected to the positive pole of the pulse generator;

[0009] A body surface electrode, which is a strip electrode and is connected to the negative pole of the pulse generator.

[0010] As a preferred solution, the catheter electrode includes:

[0011] A cylindrical conductor, the distal end of the cylindrical conductor is wound into the annular electrode, and the proximal end of the cylindrical conductor is connected to the positive electrode of the pulse generator;

[0012] A catheter is sleeved outside the cylindrical conductor, and both ends extend out of both ends of the cylindrical conductor.

[0013] As a preferred solution, the outer ring side of the annular electrode is a conductive surface, and the inner ring side of the annular electrode is coated with an insulating layer.

[0014] As a preferred solution, the catheter electrode includes:

[0015] A balloon, which is hollow inside;

[0016] An ablation electrode strip is circumferentially arranged around the balloon to form the annular electrode, and is connected to the positive electrode of the pulse generator through an ablation wire;

[0017] A catheter is sleeved outside the ablation wire, and both ends extend out of both ends of the ablation wire. The distal end of the catheter is communicated with the proximal end of the balloon;

[0018] A catheter extension part, the proximal end is communicated with the distal end of the balloon, and the distal end is a closed end;

[0019] A detection electrode strip is circumferentially arranged around the catheter extension part.

[0020] As a preferred solution, the effective area of the annular electrode is not more than 2 cm 2 , and the outer diameter of the annular electrode is 15 mm to 30 mm.

[0021] As a preferred solution, the effective area of the body surface electrode is not less than 100 cm 2 .

[0022] As a preferred solution, the pulse duration range of the pulse generator is 5 ms to 20 ms.

[0023] As a preferred solution, the number of ablation pulses output by the pulse generator is a single ablation pulse.

[0024] As a preferred solution, the ablation energy range output by the pulse generator is 100 J to 360 J.

[0025] As a preferred solution, the waveform shape of the ablation pulse output by the pulse generator is a square wave, and the square wave is a biphasic wave or a monophasic wave.

[0026] As a preferred solution, the pulse generator includes a DC power supply, an energy storage capacitor, a high-frequency drive module, a transformer, a rectification and filtering module, a positive terminal and a negative terminal connected in sequence.

[0027] As a preferred solution, the DC power supply includes a main power supply and a backup power supply. The main power supply uses a medical power supply, and the backup power supply uses a storage battery.

[0028] As a preferred solution, the energy storage capacitor is formed by paralleling at least one of a high-frequency low-resistance capacitor or a supercapacitor.

[0029] As a preferred solution, the pulse generator further includes a control circuit, and the control circuit includes:

[0030] A signal detection module, connected to the negative electrode end of the pulse generator, for detecting the ablation voltage, ablation current, and the impedance between the catheter electrode and the body surface electrode;

[0031] A bioelectric potential detection module, having body surface electrocardiogram electrodes, for detecting the body surface electrocardiogram and measuring the local pulmonary vein potential;

[0032] A detection control module, the signal input end of which is connected to the signal output end of the signal detection module through an optocoupler, and another signal input end is connected to the signal output end of the bioelectric potential detection module through another optocoupler, and the signal output end is connected to the control end of the high-frequency driving module;

[0033] A man-machine interaction device, connected to the interaction end of the detection control module.

[0034] A control method for the above-mentioned cardiac ablation pulsed electric field control device includes:

[0035] After detecting the electrocardiogram synchronization signal, drive the pulse generator to start discharging, and obtain the ablation voltage, ablation current, and the impedance between the catheter electrode and the body surface electrode in real time;

[0036] If the impedance is lower than the preset minimum value, control the ablation pulse output by the pulse generator in a constant current mode; if the impedance is higher than the preset maximum value, control the ablation pulse output by the pulse generator in a constant voltage mode;

[0037] Use the preset pulse duration to control the ablation energy of the pulse generator, integrate the ablation pulse power output by the pulse generator in real time according to the ablation voltage and ablation current to obtain the real-time ablation energy, and when the ablation energy reaches the set value, the discharging ends.

[0038] An operation method for the above-mentioned cardiac ablation pulsed electric field control device includes:

[0039] S1, paste the body surface electrocardiogram electrodes;

[0040] S2, place the catheter electrode at the pulmonary vein ostium;

[0041] S3. Determine the position of the body surface electrode on the chest surface according to the orientation of the catheter electrode, and try to make the pulsed electric field perpendicular to the ablation target tissue.

[0042] S4. Adjust the diameter of the annular electrode of the catheter electrode. According to the impedance change trend between the catheter electrode and the body surface electrode, determine the degree of apposition of the annular electrode to the pulmonary vein ostium. When the impedance change is within the preset change range, it is considered that the adjustment is completed.

[0043] S5. Set the ablation energy, select the pulse waveform, and then press the discharge button of the pulse generator until the pulse generator finishes discharging.

[0044] S6. Judge the effect of electrical isolation according to the information of local pulmonary vein potential and body surface electrocardiogram. If successful, the ablation is completed; otherwise, return to step S5 for ablation again.

[0045] The positive and progressive effects of the present invention are as follows: The present invention adopts a cardiac ablation pulsed electric field control device, control method and operation method, and has the following advantages:

[0046] 1. Two groups of electrodes, namely body surface electrodes and catheter electrodes, are adopted to improve the penetration depth of the pulsed electric field and the efficiency of electroporation.

[0047] 2. The catheter electrode has a simple structure and high reliability. Only a cylindrical conductor or an ablation wire is needed, and the diameter is small, which is easy to insert. The annular conductive band improves the continuity of the ablation target tissue and improves the electrical isolation effect of the pulmonary vein. Especially, an insulating layer is adopted on the blood side, which greatly reduces the energy loss.

[0048] 3. Single-pulse ablation is adopted and the ablation time is shortened to the millisecond level, avoiding the influence of catheter electrode displacement caused by skeletal muscle contraction of the patient on the ablation accuracy. At the same time, the transient contraction of skeletal muscle reduces the pain of the patient.

[0049] 4. The pulse waveform can be single-phase or bipolar, and the adjustable range of pulse energy is wide, providing more choices for clinicians.

[0050] 5. The isolation barrier guarantee device meets the technical requirements of the "Medical Electrical Safety Standard" for CF-type devices and can be directly used for cardiac ablation.

[0051] 6. By setting a bioelectric potential detection module, R-wave synchronized discharge is realized, avoiding ventricular fibrillation caused by ablation pulses.

[0052] 7. The control modes of constant voltage, constant current and constant energy avoid barotrauma caused by arc discharge while ensuring the electroporation effect.

[0053] 8. The impedance method is used to determine the degree of apposition of the catheter electrode, and no additional sensor is required. Description of the Drawings

[0054] Figure 1 Schematic diagram of a circuit connection for the present invention;

[0055] Figure 2 Schematic diagram of a structure of the catheter electrode of the present invention;

[0056] Figure 3 Plan view of the catheter electrode of the present invention;

[0057] Figure 4 is Figure 3 an application diagram of;

[0058] Figure 5 Another schematic diagram of the structure of the catheter electrode of the present invention;

[0059] Figure 6 Schematic diagram of the method for adjusting the electric field direction of the present invention;

[0060] Figure 7(a) and Figure 7(b) are ablation pulse waveforms output by the pulse generator of the present invention;

[0061] Figure 8 An application schematic diagram of the present invention. Detailed implementation manners

[0062] In order to make the technical means, creative features, achieved purposes and functions of the present invention easy to understand, the present invention will be further described below with reference to specific illustrations.

[0063] In the present invention, when describing the cardiac ablation pulse electric field control device, "proximal" refers to the side of the cardiac ablation pulse electric field control device located on one side of the delivery device or on the side in the direction of the end manipulated by the user. Correspondingly, "distal" refers to the side of the cardiac ablation pulse electric field control device away from the delivery device or away from the end manipulated by the user.

[0064] Referring to Figure 1 and Figure 8 , a cardiac ablation pulse electric field control device includes a pulse generator 1 and an electrode connected to each other. The electrode includes a catheter electrode 21 and a body surface electrode 22. The distal end of the catheter electrode 21 is a ring electrode 211, and the catheter electrode 21 is connected to the positive electrode of the pulse generator 1. The body surface electrode 22 is a strip electrode, and the body surface electrode 22 is connected to the negative electrode of the pulse generator 1.

[0065] During use, the pulse generator 1 is placed outside the body, the catheter electrode 21 is sent into the body through a catheter, and the body surface electrode 22 can be arranged around the patient's chest according to the position of the catheter electrode 21 on the body surface.

[0066] In theory, pulsed electric field ablation can damage myocardial cells without heating the tissue, and has cell / tissue selectivity to protect surrounding key structures. Irreversible electroporation uses pulsed electric field as the energy form. Therefore, the efficiency of electroporation is directly related to the parameters of the pulsed electric field. These parameters include electric field strength, electric field direction, duration, number of pulses, pulse energy, etc.

[0067] Regarding the electric field strength, since human tissue is a conductor, applying a voltage generates a current. If there is no current, there is no voltage, that is, no electric field. It can be seen that the electric field in human tissue is maintained by the current. Therefore, the pulse generator 1 needs to output both a sufficiently high voltage and a sufficient current. By changing the output voltage of the pulse generator, the electric field strength in the human body can be changed. The high-voltage electric pulse output by the pulse generator forms a pulsed electric field between the surface electrode and the catheter electrode. The electric field strength is proportional to the pulsed voltage and is related to the distance from the catheter electrode. The closer to the catheter electrode, the stronger the electric field strength. Therefore, by adjusting the pulsed voltage, the electric field strength at the ablation target tissue can be adjusted.

[0068] Regarding the electric field direction, when pulsed electric field ablation is used to achieve pulmonary vein electrical isolation, transmural ablation must be achieved, penetrating the heart wall radially along the vein. The necessity of continuous transmural ablation means dealing with cells with significantly different orientations relative to the electric field direction. Therefore, achieving uniform electroporation independent of the cell direction can ensure reliable electrical isolation. The electroporation efficiency is maximum when the pulsed electric field direction is perpendicular to the cell membrane and minimum when parallel. The electroporation efficiency has an approximate cosine relationship with the angle between the electric field and the cell membrane and is independent of the positive and negative of the pulse.

[0069] Existing ablation catheters consist of multiple conductive parts and insulating parts to form two or more electrodes, which are located at the tip of the catheter, and the ablation target tissue surrounds the catheter tip. Since both the positive and negative electrodes generating the electric field are at the tip of the catheter, no matter how these positive and negative electrodes are combined, the electric field will not be maximum in the upward direction of the vein diameter. Moreover, the electric field strength decays exponentially with the increasing distance from the electrode, and the penetration depth is relatively shallow. The insulating parts of multiple electrodes affect the distribution of the electric field, resulting in a decrease in the electric field strength near the insulating parts and affecting the continuity of the ablation effect.

[0070] The present invention uses a catheter electrode 21 and a surface electrode 22, and the ablation target tissue is located between the two electrodes, so that the electric field direction is along the vein radius, improving the electroporation efficiency. As Figure 6 shown, C represents the catheter electrode 21, S represents the surface electrode 22, represents the pulsed electric field, and A represents the ablation target tissue. The catheter electrode C and the surface electrode S are placed on the inner and outer sides of the ablation target tissue A. Regardless of the positive and negative of the applied voltage, the electric field The directions are all radial. In this way, the electric field strength decays linearly with the increase of the distance from the electrode, and the penetration distance is relatively long. The continuous conductive layer of the catheter electrode 21 ensures the uniformity of the ablation effect. The body surface electrode 22 has two functions. One is to provide a conductive loop for the pulsed electric field, and the other is to adjust the distribution of the pulsed electric field in the human body. By changing the position of the body surface electrode 22, the distribution of the pulsed current in the human body can be changed, thereby changing the direction of the electric field.

[0071] In some embodiments, referring to Figure 2 , the catheter electrode 21 can adopt an annular cylindrical catheter electrode. The catheter electrode 21 includes a cylindrical conductor and a catheter 212. The distal end of the cylindrical conductor is wound into an annular electrode 211, and the proximal end of the cylindrical conductor is connected to the positive pole of the pulse generator 1. The catheter 212 is sleeved outside the cylindrical conductor. The distal end of the catheter 212 is extended by the distal end of the cylindrical conductor, that is, the cylindrical conductor is located outside the distal end of the catheter 212. The proximal end of the catheter 212 is extended by the proximal end of the cylindrical conductor, that is, the proximal end of the cylindrical conductor extends out of the proximal end of the catheter 212 and then is connected to the positive pole of the pulse generator 1.

[0072] In some embodiments, referring to Figure 3 , the outer ring side of the annular electrode 211 is a conductive surface 2111, and the inner ring side of the annular electrode 211 is coated with an insulating layer 2112. As shown in Figure 4 , when the annular electrode 211 is used, it is placed at the pulmonary vein port. The outer ring side is in contact with the pulmonary vein and is located inside the blood vessel wall 91, and the inner ring side is in contact with the blood 92. Therefore, in the present invention, an insulating layer 2112, such as a medical Teflon coating, is coated on the inner ring side in contact with the blood 92. The ablation target tissue 93 is located outside the outer ring side of the annular electrode 211.

[0073] In some embodiments, referring to Figure 5 , the catheter electrode 21 can also adopt a balloon-type ablation catheter electrode. At this time, the catheter electrode 21 includes a balloon 213, an ablation electrode band 214, a catheter 215, a catheter extension 216, and a detection electrode band 217. The balloon 213 is in the shape of a hollow sphere or ellipsoid. The ablation electrode band 214 is arranged circumferentially around the balloon 213 to form an annular electrode 211. The ablation electrode band 214 is connected to the positive pole of the pulse generator 1 through an ablation wire. The catheter 215 is sleeved outside the ablation wire. The distal end of the catheter 215 is extended by the distal end of the ablation wire and is connected to the ablation electrode band 214. The proximal end of the catheter 215 is extended by the proximal end of the ablation wire and is connected to the positive pole of the pulse generator 1. The distal end of the catheter 215 is communicated with the proximal end of the balloon 213. The proximal end of the catheter extension 216 is communicated with the distal end of the balloon 213, and the distal end of the catheter extension 216 is a closed end. The detection electrode band 217 is arranged circumferentially around the catheter extension 216.

[0074] When the balloon ablation catheter electrode is in use, the balloon 213 is inserted into the ostium of the pulmonary vein, so that the ablation electrode band 214 is placed at the ostium of the pulmonary vein, the detection electrode band 217 is placed in the pulmonary vein, and the diameter of the balloon 213 can be adjusted according to the size of the pulmonary vein port. The detection electrode band 217 is used to measure the local biopotential (pulmonary vein potential) between the ablation electrode band 214 and the detection electrode band 217 after ablation to determine whether the isolation is successful.

[0075] In some embodiments, the effective area of the annular electrode 211 is not greater than 2 cm 2 , and the outer diameter of the annular electrode 211 is 15 mm to 30 mm.

[0076] When the present invention is in use, the annular electrode 211 extends into the patient's body and is arranged at the pulmonary vein port, so the diameter of the annular electrode 211 can be adjusted according to the size of the pulmonary vein port.

[0077] In some embodiments, the effective area of the body surface electrode 22 is not less than 100 cm 2 . The body surface electrode 22 is located outside the body, so the effective area can be appropriately larger.

[0078] In some embodiments, the pulse duration range of the pulse generator 1 is 5 ms to 20 ms.

[0079] For the pulse duration, the electropermeabilization threshold electric field strength of human tissue is related to the pulse duration. The threshold electric field strength of nanosecond pulses is on the order of ten kilovolts per centimeter; the threshold electric field strength of microsecond pulses is on the order of kilovolts per centimeter; the threshold electric field strength of millisecond pulses is on the order of hundreds of volts per centimeter. The present invention uses millisecond pulses to reduce the ablation voltage, thereby avoiding the generation of high-temperature arcs by the catheter electrode and causing air pressure damage to the surrounding tissues.

[0080] In some embodiments, the number of ablation pulses output by the pulse generator 1 is a single ablation pulse.

[0081] For the number of pulses, in the prior art, multiple pulses are mostly used to provide energy. In order to avoid causing fatal ventricular fibrillation, R-wave synchronous discharge is required. After the action of the strong pulsed electric field, the baseline drift of the electrocardiogram will occur, affecting the accuracy of R-wave detection and bringing difficulties to the synchronous discharge of subsequent pulses. In addition, the action of the strong pulsed electric field will cause skeletal muscle contraction, resulting in the movement of the catheter electrode relative to the target tissue and affecting the ablation effect. Using high-frequency pulses attempts to eliminate the electrical stimulation of skeletal muscle, but the multiple on-off processes are equivalent to the diode rectification effect, so the skeletal muscle contraction cannot be completely eliminated. In addition, multiple-pulse ablation will delay the ablation treatment time.

[0082] The present invention uses a single ablation pulse. Since the patient is in a calm state before the pulse is delivered, it is easy to collect the patient's electrocardiogram and accurately detect the R wave. For example, when the duration of the ablation pulse is less than 20 milliseconds, since the reaction time of skeletal muscle is about 100 milliseconds after being stimulated by the ablation pulse, when the skeletal muscle contracts, the ablation pulse has already been delivered, thus avoiding the influence of skeletal muscle contraction on the ablation effect. Another advantage of the single pulse is that the patient's skeletal muscle only has one transient contraction, reducing the patient's pain.

[0083] In some embodiments, the ablation energy output by the pulse generator 1 ranges from 100 J to 360 J.

[0084] For the ablation energy, in the pulsed electric field ablation method, as the ablation energy increases, the ablation range increases proportionally. Since the present invention uses surface electrodes and catheter electrodes, most of the pulsed energy is absorbed by the tissue between the surface electrodes and the catheter electrodes, and only a small part is absorbed by the ablation target tissue. The energy absorbed by the ablation target tissue should not only meet the need for electroporation but also not generate too much heat to cause the temperature of the ablation target tissue to rise too high. The ablation energy range is preferably from 100 J to 360 J. The ablation energy can be controlled by the duration. After the discharge starts, the pulse power is integrated to obtain the real-time ablation energy. When the ablation energy reaches the set value, the discharge ends.

[0085] In some embodiments, referring to FIGS. 7(a) and 7(b), the waveform shape of the ablation pulse output by the pulse generator 1 is a square wave, and the square wave is a biphasic wave or a monophasic wave.

[0086] For the pulse waveform, the waveform shape of the ablation pulse of the present invention is a square wave, which can be a biphasic wave as shown in FIG. 7(a) or a monophasic wave as shown in FIG. 7(b). Among them, the pulse current is automatically adjusted according to the impedance of the ablation target tissue, and the duration changes according to the energy set by the operation.

[0087] In some embodiments, the pulse generator 1 can use the pulse generator 1 in the prior art. Referring to Figure 1 , the pulse generator 1 can also have the following structure: The pulse generator 1 includes a DC power supply 11, an energy storage capacitor 12, a high-frequency drive module 13, a transformer 14, a rectifier filter module 15, a positive terminal, and a negative terminal that are connected in sequence.

[0088] In some embodiments, the DC power supply 11 includes a main power supply and a backup power supply. The main power supply uses a medical power supply, and the backup power supply uses a storage battery.

[0089] The DC power supply 11 provides a low-voltage power supply. The DC power supply 11 uses two power supplies, a medical power supply and a storage battery, to supply power to the system. The medical power supply serves as the main power supply, and the storage battery serves as the backup power supply to ensure uninterrupted power supply to the system during the treatment process. The voltage of the DC power supply 11 is within the safety extra-low voltage range, not exceeding 60V, preferably between 30V and 60V.

[0090] In some embodiments, the energy storage capacitor 12 is formed by paralleling at least one of a high-frequency low-resistance capacitor or a supercapacitor.

[0091] The energy storage capacitor 12 stores sufficient energy for use when delivering ablation pulses. The energy storage capacitor 12 is formed by paralleling a supercapacitor and / or a high-frequency low-resistance capacitor, and at the same time provides sufficient instantaneous current. Although the more energy stored the better, too much energy will increase the volume and weight of the pulse generator. For a compromise, the energy storage of the energy storage capacitor 12 of the present invention is selected to be 1F to 10F.

[0092] In some embodiments, the high-frequency drive module 13 converts the DC voltage on the energy storage capacitor 12 into an AC square wave of 100 kHz to 300 kHz and applies it to the primary coil of the transformer 14.

[0093] In some embodiments, the transformer 14 raises the voltage of the low-voltage power supply to the high voltage required for ablation pulses, and at the same time provides an electromagnetic isolation barrier between the ablation electrode and the low-voltage power supply.

[0094] In some embodiments, the rectification and filtering module 15 restores the 100 kHz to 300 kHz AC square wave output by the transformer into a DC pulse.

[0095] In some embodiments, the pulse generator 1 further includes a control circuit 16, and the control circuit 16 includes a signal detection module 161, a biopotential detection module 162, a detection control module 163, and a human-machine interaction device.

[0096] The signal detection module 161 is connected to the negative extreme of the pulse generator 1. The signal detection module 161 is used to detect the ablation voltage, ablation current, and the impedance between the catheter electrode 21 and the body surface electrode 22. The signal detection module 161 can adopt a detection module in the prior art that can detect voltage, current, and impedance.

[0097] The biopotential detection module 162 has body surface electrocardiogram electrodes. The biopotential detection module 162 is used to detect the body surface electrocardiogram to achieve R-wave synchronized discharge. The biopotential detection module 162 is used to measure the local pulmonary vein potential to evaluate the ablation effect according to the change in the pulmonary vein potential amplitude.

[0098] The signal input end of the detection control module 163 is connected to the signal output end of the signal detection module 161 through the optocoupler 166. Another signal input end of the detection control module 163 is connected to the signal output end of the bioelectric potential detection module 162 through another optocoupler 167. The signal output end of the detection control module 163 is connected to the control end of the high-frequency drive module 13. The optocoupler provides an optoelectronic isolation barrier between the bioelectric potential detection module 162 and the detection control module 163. The detection control module 163 controls the parameters of the ablation pulse according to the information obtained by the signal detection module 161 and the bioelectric potential detection module 162 and the information input by the operator.

[0099] The human-computer interaction device is connected to the interaction end of the detection control module 163, providing a human-computer interface for the operator and the patient. The human-computer interaction device may include a display 164 and a keyboard 165. The human-computer interaction device may also include a touch display screen.

[0100] In some embodiments, the pulse generator 1 further includes a discharge key for driving the pulse generator 1 to discharge.

[0101] In some embodiments, the present invention also provides a control method for controlling the above-mentioned cardiac ablation pulsed electric field control device, including the following steps:

[0102] S1. After detecting the electrocardiogram synchronization signal, drive the pulse generator 1 to start discharging, and obtain the ablation voltage, ablation current, and impedance between the catheter electrode 21 and the body surface electrode 22 in real time.

[0103] The body surface electrocardiogram can be detected by the bioelectric potential detection module 162 to achieve R-wave synchronous discharge and obtain the electrocardiogram synchronization signal. Discharging work is only carried out after obtaining the electrocardiogram synchronization signal. The above-mentioned real time in this step is in the way of obtaining signals regularly according to a preset period. For example, the ablation voltage, ablation current, and impedance between the catheter electrode 21 and the body surface electrode 22 are obtained once every 1 ms interval.

[0104] S2. If the impedance is lower than the preset minimum value, control the ablation pulse output by the pulse generator 1 in a constant current mode. If the impedance is higher than the preset maximum value, control the ablation pulse output by the pulse generator 1 in a constant voltage mode.

[0105] S3. Control the ablation energy of the pulse generator 1 using the preset pulse duration. Integrate the ablation pulse power output by the pulse generator 1 in real time according to the ablation voltage and ablation current to obtain the real-time ablation energy. When the ablation energy reaches the set value, the discharging ends.

[0106] The present invention controls the ablation pulse in the above three ways of constant voltage, constant current, and constant energy. The detection control module 163 of the present invention preferably controls the pulse generator 1 by using the above control method.

[0107] In some embodiments, the present invention further provides an operation method of the above-mentioned cardiac ablation pulsed electric field control device, including the following steps:

[0108] S1, Paste surface electrocardiogram electrodes for detecting surface electrocardiogram to achieve R-wave synchronized discharge.

[0109] S2, Insert the catheter electrode 21 into the ostium of the pulmonary vein.

[0110] S3, According to the orientation of the catheter electrode 21, determine the position of the surface electrode 22 on the chest surface of the body, and try to make the pulsed electric field perpendicular to the ablation target tissue.

[0111] S4, Adjust the diameter of the annular electrode 211 of the catheter electrode 21. According to the impedance change trend between the catheter electrode 21 and the surface electrode 22, determine the degree of contact between the annular electrode 211 and the ostium of the pulmonary vein. When the impedance change is within the preset change range, it is considered that the adjustment is completed.

[0112] Before applying the ablation current, the impedance between the annular electrode 211 of the catheter electrode 21 and the surface electrode 22 can be detected to judge whether the catheter electrode 21 is in place. Gently push the catheter electrode 21 forward. If the impedance increases very little, it means that the catheter is in good contact with the pulmonary vein. If the contact is not good and there is blood in the middle, the resistance is relatively small.

[0113] S5, Set the ablation energy, select the pulse waveform, and then press the discharge button of the pulse generator 1 until the discharge of the pulse generator 1 ends.

[0114] After detecting the electrocardiogram synchronization signal, the pulse generator 1 starts to discharge and ends when the set energy is reached.

[0115] S6, Judge the electrical isolation effect according to the information of the local pulmonary vein potential and the surface electrocardiogram. If it is successful, the ablation ends; otherwise, return to step S5 for ablation again.

[0116] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above-mentioned embodiments. What is described in the above embodiments and the specification only illustrates the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. A cardiac ablation pulsed electric field control device, comprising a pulse generator and an electrode connected to each other; It is characterized in that The electrode includes: A catheter electrode, the distal end of which is an annular electrode, connected to the positive electrode of the pulse generator; A body surface electrode, which is a strip-shaped electrode, connected to the negative electrode of the pulse generator; The catheter electrode includes: A cylindrical conductor, the distal end of the cylindrical conductor is wound into the annular electrode, and the proximal end of the cylindrical conductor is connected to the positive electrode of the pulse generator; A catheter, sleeved outside the cylindrical conductor, and both ends protrude from both ends of the cylindrical conductor; The outer ring side of the annular electrode is a conductive surface, and the inner ring side of the annular electrode is coated with an insulating layer; During use, the body surface electrode is arranged around the patient's chest according to the position of the catheter electrode on the body surface, and the ablation target tissue is located between the catheter electrode and the body surface electrode, so that the electric field direction is along the radial direction of the pulmonary vein.

2. The cardiac ablation pulsed electric field control device according to claim 1, wherein The effective area of the annular electrode is not greater than 2 cm 2 , and the outer diameter of the annular electrode is 15 mm to 30 mm; The effective area of the body surface electrode is not less than 100 cm 2 ; The pulse duration range of the pulse generator is 5 ms to 20 ms; The number of ablation pulses output by the pulse generator is a single ablation pulse; The ablation energy range output by the pulse generator is 100 J to 360 J; The waveform shape of the ablation pulse output by the pulse generator is a square wave, and the square wave is a biphasic wave or a monophasic wave.

3. The cardiac ablation pulsed electric field control device according to claim 1, wherein The pulse generator includes a DC power supply, an energy storage capacitor, a high-frequency drive module, a transformer, a rectifier filter module, a positive terminal and a negative terminal connected in sequence.

4. The cardiac ablation pulsed electric field control device according to claim 3, characterized in that, The DC power supply includes a main power supply and a backup power supply. The main power supply uses a medical power supply, and the backup power supply uses a storage battery; The energy storage capacitor is formed by connecting at least one of a high-frequency low-resistance capacitor or a super capacitor in parallel.

5. The cardiac ablation pulsed electric field control device according to claim 3, characterized in that, The pulse generator further includes a control circuit, and the control circuit includes: A signal detection module, connected to the negative terminal of the pulse generator, to detect the ablation voltage, ablation current, and the impedance between the catheter electrode and the body surface electrode; A biopotential detection module, having body surface electrocardiogram electrodes, to detect the body surface electrocardiogram and measure the local pulmonary vein potential; A detection control module, the signal input terminal is connected to the signal output terminal of the signal detection module through an opto-coupler, and another signal input terminal is connected to the signal output terminal of the biopotential detection module through another opto-coupler, and the signal output terminal is connected to the control terminal of the high-frequency drive module; A man-machine interaction device, connected to the interaction terminal of the detection control module.

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