CN-116269731-B - Pulsed electric field ablation system

Abstract

The invention provides a pulsed electric field ablation system which comprises an ablation catheter and ablation equipment, wherein the ablation catheter is connected with the ablation equipment, the ablation catheter comprises an operation handle, a catheter main body and a treatment head, the operation handle of the ablation catheter is positioned at the proximal end of the catheter main body, the treatment head of the ablation catheter is positioned at the distal end of the catheter main body, the proximal end of the operation handle is connected with the ablation equipment through a tail line, the ablation equipment comprises a control system, the control system can control and switch each group of electrodes to conduct impedance measurement or ablation, the impedance between the electrodes is obtained through calculation by using alternating current signals to measure voltage and current values, whether the electrodes are well attached to myocardial tissues is judged and confirmed through the impedance values, the effectiveness of the ablation energy reaching a target point is improved through good attachment, different pairing combinations of the electrodes are achieved through a switching circuit, then optimal electrode combination discharge is selected according to judgment, and an optimal operation ablation scheme is formed, namely an optimal operation ablation scheme is obtained according to different pulmonary vein shapes.

Inventors

• TAN JIAHONG
• YANG YONGGANG
• GUAN DING

Assignees

• 上海鑫律通生命科技有限公司

Dates

Publication Date

20260505

Application Date

20230222

Claims (3)

1. 1. A pulsed electric field ablation system, characterized by comprising an ablation catheter (1) and an ablation device (2), the ablation catheter (1) being connected to the ablation device (2); the ablation catheter (1) comprises an operation handle (11), a catheter main body (12) and a treatment head (13), wherein the operation handle (11) of the ablation catheter (1) is positioned at the proximal end of the catheter main body (12), and the treatment head (13) of the ablation catheter (1) is positioned at the distal end of the catheter main body (12); the treatment head (13) comprises a spline basket having a plurality of splines, wherein each spline comprises a plurality of electrodes, the electrodes comprising ablation electrodes and mapping electrodes; The ablation device (2) comprises a control system; the control system comprises a switching circuit (23), a high-voltage pulse output circuit (24) and an impedance measurement circuit (25), wherein the high-voltage pulse output circuit (24) and the impedance measurement circuit (25) are connected with the switching circuit (23), and the switching circuit (23) is connected with an ablation electrode on the spline; the control system selects the pairing combination of the ablation electrodes through the switching circuit so as to generate a superimposed ablation electric field in a tissue region, thereby realizing complete coverage of the ablation region; The automatic switching discharge of the switching circuit (23) is realized through one-time operation, and the discharge combination sequence is not limited, so that a transverse, vertical, oblique and interval discharge electric field can be formed, and each discharge ablation area is mutually overlapped in a crossing way to form a continuous and complete discharge effect, thereby realizing the complete coverage of the ablation area; The control system controls and switches each electrode on the spline to conduct any one group or several groups of pairing and conduct impedance measurement or ablation; The impedance measurement adopts alternating voltage and alternating current measurement, a voltage value V and a current value I are measured through a voltmeter, and then the impedance Z is calculated according to a formula Z=U/I; firstly judging the electrode leaning degree according to the impedance measurement value, if the impedance value of a certain group of electrodes is smaller than the threshold value range, judging that the group of electrodes are poorly leaned against myocardial tissues, and disconnecting the group of electrodes during discharging to form a recommended discharging electrode combination; When impedance between each group of electrodes is measured, an alternating current signal is sent out, and the frequency, amplitude and phase of the alternating current signal can be adjusted; And (3) measuring to obtain a list of impedance of different electrode combinations by switching the paired combinations of the electrodes, and judging and determining the contact condition between the current electrode and the myocardial tissue pair by threshold setting and software to form an electrode combination discharge scheme recommended by the operation.
2. 2. The pulsed electric field ablation system of claim 1, wherein each of the electrodes corresponds to two relay switches, the relays comprising relay a and relay B, i.e., the nth electrode corresponds to relay An and relay Bn, the relay a being used to switch whether the ablation electrode corresponds to the positive or negative terminal of the high voltage output, the relay B being used to impedance measure or discharge ablate the switch.
3. 3. The pulsed electric field ablation system of claim 2, wherein each electrode is configured such that a normally open contact of the relay An is connected to a positive side of the high voltage pulse output, a normally closed contact of the relay An is connected to a negative side of the high voltage pulse output, a common side COM of the relay An is connected to a normally open contact of the relay Bn, a normally closed contact of the relay Bn is connected to An impedance measuring circuit (25), a COM side of the relay Bn is connected to An electrode Pn, control signals of the two relays are connected to a controlled IO signal, and the IO signal drives switching of the relay through a driving circuit.

Description

Pulsed electric field ablation system Technical Field The invention relates to the field of medical appliances, in particular to a pulsed electric field ablation system. Background Ablation is first used in the treatment of supraventricular tachycardia patients with the auxiliary pathways and pre-excitation syndromes, and today, ablation is also used in the treatment of atrial flutter, fibrillation and ventricular arrhythmias. The cornerstone of atrial fibrillation treatment is the isolation of the pulmonary veins in the left atrium, and pulsed electric fields are of great interest for their excellent effectiveness and safety. In the field of atrial fibrillation treatment, bidirectional conduction block is realized mainly through pulmonary vein isolation, so that the aim of incapacity of conducting abnormal electric signals is fulfilled. The pulse electric field ablation core is to destroy abnormal myocardial cells (irreversible electroporation) by an electric field, thereby preventing abnormal electrocardiosignal transmission and achieving the aim of treating tachycardia diseases such as atrial fibrillation. When the catheter releases an electric field through the electrodes inside the heart, more electric field energy is introduced into the blood rather than targeted to myocardial tissue due to inconsistent impedance between the blood and myocardial tissue, particularly in conditions of poor tissue apposition. In the prior art, when an ablation area is discharged, the electrode only presents one electric field distribution state in a vertical discharge mode, so that a discontinuous ablation area is generated in the ablation area after discharge, the discharge distribution is incomplete, and the ablation effect of the ablation area is not optimal. Patent CN114404035A discloses an ablation device with a mapping function, comprising an outer tube, an ablation assembly provided at a distal end of the outer tube, comprising a radially contractible and expandable support skeleton and a plurality of electrodes provided on the support skeleton, wherein at least one first electrode capable of being used for mapping is provided in the plurality of electrodes, a connector provided at a proximal end of the outer tube, the connector comprising a plurality of conductive terminals through which the connector is electrically connected with the plurality of electrodes, at least one first terminal being provided in the plurality of conductive terminals, each first terminal being electrically connected with a corresponding one of the first electrodes in a one-to-one manner, so that the first electrodes are capable of being used for mapping through the first terminals when the connector is connected to an external mapping device. The patent enables the ablation device to have the functions of mapping and ablation, solves the problems that two devices of an ablation catheter and a mapping catheter are required to be guided respectively in an operation, and simplifies operation, but the ablation device in the patent cannot realize connection and uniform discharge of electrodes in an ablation area, and has poor ablation effect on the ablation area. Patent WO2022171149A1 discloses an ablation device, which comprises an outer tube, a supporting framework and an ablation member, wherein the supporting framework is arranged at the distal end of the outer tube and is in a radially contractible and expandable bracket structure, the supporting framework comprises a bearing frame and a connecting piece, the connecting piece is used for connecting every two adjacent bearing rods so as to keep the distance between the adjacent bearing rods, and the ablation member is arranged on the supporting framework and is used for outputting ablation energy to ablate a target ablation area. This patent passes through connecting piece and connects adjacent carrier bar to when the carrier frame receives external force to take place deformation, pull adjacent carrier bar, keep the interval between the adjacent carrier bar, keep the stability of carrier bar position, make the whole difficult distortion of carrier frame, avoid the interval to lead to the contact to take place the short circuit between the ablation piece too little between the carrier bar, avoid the damage of breaking down to target tissue, and then improve the ablation security, but this ablation device does not have the mapping function. Patent WO2022007490A1 discloses a system for treating arrhythmias using pulsed electric field ablation techniques, comprising a voltage pulse system console comprising an electric pulse generator, a controller, a human-machine interface and a transducer, a pacing and ECG unit comprising a cardiac stimulator, an ECG recorder, a pacing catheter, a mapping catheter and a connector, and an ablation catheter comprising sequentially connected distal, main middle and proximal control handles, the ablation catheter being connected to the system console by the t