CN111437513B

CN111437513B - Multi-mode high-voltage ultrashort pulse electric field atrial fibrillation treatment electrode and treatment equipment

Info

Publication number: CN111437513B
Application number: CN202010214982.XA
Authority: CN
Inventors: 请求不公布姓名
Original assignee: Hangzhou Vena Anke Medical Technology Co ltd
Current assignee: Hangzhou Vena Anke Medical Technology Co ltd
Priority date: 2020-03-24
Filing date: 2020-03-24
Publication date: 2023-05-16
Anticipated expiration: 2040-03-24
Also published as: CN111437513A

Abstract

The invention discloses a multimode high-voltage ultrashort pulse electric field atrial fibrillation treatment electrode and treatment equipment. The treatment equipment mainly comprises a system controller, a multi-mode high-voltage ultrashort pulse electric field generation module, an atrial fibrillation treatment electrode and a real-time monitoring module; the method solves the problems of single treatment parameters and modes in the pulse ablation technology and the problem that the pulse action process cannot be monitored in real time.

Description

Multi-mode high-voltage ultrashort pulse electric field atrial fibrillation treatment electrode and treatment equipment

Technical Field

The invention relates to the field of pulse ablation, in particular to a multimode high-voltage ultrashort pulse electric field atrial fibrillation treatment electrode and treatment equipment.

Background

Paroxysmal atrial fibrillation (atrial fibrillation), particularly atrial fibrillation without organic heart disease, has one of the main occurrence mechanisms of rapid electric activation triggering from pulmonary vein cuffs, and therefore, the radical treatment purpose can be achieved by isolating the anatomical connection or electric activation connection (conduction) relationship of the pulmonary vein cuffs and atria through a surgical or catheter radio frequency ablation method. Catheter ablation is thus an important component of the overall treatment of atrial fibrillation, and the recommended level in medical guidelines is also increasing.

Currently in clinical use is radiofrequency ablation or thermal/cryoablation, where conventional ablative energy relies on time-dependent conduction of heating or cooling, and extreme temperatures, either high (60 ℃) or cryogenic (-160 ℃) of radiofrequency, ablate all tissues (including normal tissues and cytoskeleton) in the target region. When the catheter works, the catheter emits high-frequency electromagnetic waves (radio frequency energy) after reaching a designated position along the inside of a blood vessel through the vascular cannula, a circle of ablation points are arranged along the pulmonary vein opening, the atrial muscle necrosis generates annular scars through temperature rise or reduction, the electric stimulation signal transmission path is cut off, and the ectopic signal source is isolated outside, so that the heart is recovered to beat regularly. However, the generation of scar is very easy to form postoperative pulmonary vein stenosis, meanwhile, the thermal cryoablation is easy to cause diaphragmatic nerve injury, the consequences are serious, and the patient has to perform subsequent treatments such as balloon dilation, stent implantation and the like.

In recent therapy, the pulse ablation technology causes irreversible electroporation of myocardial cells by high-intensity instantaneous electric field energy, so that nanoscale pores appear on the surface of cell membranes and apoptosis is induced, thereby ablating tissues and blocking transmission of ectopic signals. However, the whole treatment process always has the problems of single treatment pulse form, insufficient selective effect, weak individuation degree of treatment parameter patients, incapability of real-time monitoring and incapability of real-time curative effect evaluation. The defects seriously restrict the popularization of the pulse ablation technology in atrial fibrillation treatment.

Disclosure of Invention

The invention aims to provide a multimode high-voltage ultrashort pulse electric field atrial fibrillation treatment electrode which mainly comprises a functional cable, a telescopic framework, a lead, an action electrode and an insulating support coil.

The functional cable is a cylinder formed by multiple layers of telescopic layers, and is sequentially provided with a treatment pulse anode I, an insulation layer I, a treatment pulse cathode I, an insulation layer II, a signal monitoring layer I, an insulation layer III and a sheath I from inside to outside.

The therapeutic pulse positive electrode I and the therapeutic pulse negative electrode I send a stimulating pulse signal to the therapeutic electrode of the acting electrode through a lead; the therapeutic pulse positive electrode I and the therapeutic pulse negative electrode I are respectively and alternately connected with the therapeutic electrode.

The therapeutic pulse anode I is connected with the telescopic framework through a lead.

The insulating layer I is used for isolating the pulse anode from the treatment pulse cathode I.

The insulating layer II is used for isolating the therapeutic pulse negative electrode I and the signal monitoring layer I.

The signal monitoring layer I is a ribbon wire which is stuck between the insulating layer II and the insulating layer III; the signal monitoring layer I is connected with the signal acquisition electrode of the action electrode, so that a monitoring pulse signal is sent to the signal acquisition electrode;

the insulating layer III is used for isolating the signal monitoring layer I and the outer skin I.

The sheath I is used for protecting the functional cable.

The telescopic framework comprises a plurality of electric telescopic rods.

One end of any electric telescopic rod is fixed on the outer side wall of the outer skin I, and the other end is adhered to the side wall of the insulating support block. The electric telescopic rods are in one-to-one correspondence with the insulating supporting blocks.

All the electric telescopic rods are arranged in an umbrella shape by taking the outer skin I as the center.

The length of the electric telescopic rod is shortest before the action electrode is inserted into the target area. After the electric telescopic rod receives a telescopic signal sent by the therapeutic pulse anode I through a lead, the length of the electric telescopic rod is changed, so that the maximum cross section area of the telescopic framework I is matched with a target area.

The active electrode is inserted into the target area.

The action electrode comprises a plurality of signal acquisition electrodes and a plurality of treatment electrodes. The signal acquisition electrodes and the treatment electrodes are alternately arranged.

The signal acquisition electrodes comprise a plurality of electric stimulation signal acquisition electrodes, a plurality of treatment pulse feedback signal acquisition electrodes and a plurality of pulse application electrodes;

the electric stimulation signal acquisition electrode is used for acquiring electric stimulation signals of the human body;

the treatment pulse feedback signal acquisition electrode is used for acquiring a voltage signal and a current signal of treatment pulses applied by the treatment electrode and/or a voltage signal and a current signal of low-energy measurement pulses applied by the pulse application electrode;

the pulse application electrode applies a low energy measurement pulse to the target area in the gap between the treatment electrode and the treatment pulse;

and the treatment electrode applies treatment pulse to the target area to complete the ablation of the biological tissue of the target area.

The therapy electrodes apply the therapy pulses simultaneously. The signal electrodes are used for independently or simultaneously collecting the electric stimulation signals of the target area and the therapeutic pulse signals of the therapeutic electrodes.

The treatment electrode and the signal acquisition electrode are both cylinders with rounded tops. The tip is the end that is inserted into the target area.

The insulating support coils comprise insulating support blocks with the same number as that of the electric telescopic rods.

One end of any insulating support block is adhered with the signal acquisition electrode, and the other end is adhered with the treatment electrode, so that the signal acquisition electrode, the insulating support block and the treatment electrode form a closed pattern.

The insulating support block is used for avoiding short circuit of the active electrode and ensuring that the distance between adjacent electrodes is not lower than a threshold value d.

The multi-mode high-voltage ultrashort pulse electric field atrial fibrillation treating electrode mainly comprises a functional cable, a telescopic skeleton, a conducting wire and an acting electrode.

The functional cable is a cylinder formed by multiple layers of telescopic layers, and is sequentially provided with a treatment pulse anode II, an insulation layer IV, a treatment pulse cathode II, an insulation layer V, a signal monitoring layer II, an insulation layer VI and a sheath II from inside to outside.

The therapeutic pulse positive electrode II and the therapeutic pulse negative electrode II send a stimulating pulse signal to the therapeutic electrode of the acting electrode through a lead; the therapeutic pulse positive electrode II and the therapeutic pulse negative electrode II are respectively and alternately connected with the therapeutic electrode;

the treatment pulse anode II is connected with the telescopic framework through a lead;

the insulating layer IV is used for isolating the pulse anode from the treatment pulse cathode II.

The insulating layer V is used for isolating the therapeutic pulse cathode II and the signal monitoring layer II.

The signal monitoring layer II is a ribbon wire which is stuck between the insulating layer IV and the insulating layer V; the signal monitoring layer II is connected with the signal acquisition electrode of the action electrode, so that a monitoring pulse signal is sent to the signal acquisition electrode;

the insulating layer VI is used for isolating the signal monitoring layer II and the outer skin II.

The sheath II is used for protecting the functional cable.

The telescopic framework comprises a plurality of electric telescopic brackets. Any telescopic bracket comprises a telescopic branch bracket I, a telescopic branch bracket II and 2 insulating blocks.

One end of the telescopic branch frame I is fixed on the outer skin II, and the other end is adhered with an insulating block.

One end of the telescopic branch frame II is fixed on the signal monitoring layer II, and the other end of the telescopic branch frame II is adhered with an insulating block.

And the signal acquisition electrode or the treatment electrode is adhered between the 2 insulating blocks, so that the signal acquisition electrode or the treatment electrode, the telescopic branch frame I, the telescopic branch frame II and the 2 insulating blocks form an arc line.

All the telescopic supports are circumferentially arranged around the outer side wall of the outer skin II.

Before the action electrode is inserted into the target area, all the electric telescopic brackets are attached with functional cables. After the electric telescopic bracket receives a telescopic signal sent by the therapeutic pulse positive electrode II through a lead, the arc length is changed, so that the maximum cross-sectional area of the telescopic bracket is matched with a target area.

The lead wire is communicated with the functional cable and the action electrode.

The lead is communicated with the functional cable and the telescopic framework.

The active electrode is inserted into the target area.

the pulse application electrode applies a low energy measurement pulse to the target area in the gap between the treatment electrode and the treatment pulse; the low-energy measurement pulse signal is a unipolar pulse, the voltage amplitude is 10-50V, the pulse width is 1-50 us, and the repetition frequency range is 0.01-10 Hz;

The therapeutic equipment with the multimode high-voltage ultrashort pulse electric field atrial fibrillation therapeutic electrode mainly comprises a system controller, a multimode high-voltage ultrashort pulse electric field generating module, an atrial fibrillation therapeutic electrode and a real-time monitoring module.

The system controller controls pulse parameters generated by the multi-mode high-voltage ultrashort pulse electric field generation module.

The voltage amplitude range of the output pulse of the multi-mode high-voltage ultra-short pulse electric field generating module is [0, 8000V ], and the pulse width range is [100ns,10ms ].

The pulse output by the multi-mode high-voltage ultra-short pulse electric field generating module comprises a single polarity pulse, a bipolar pulse, a single polarity-bipolar pulse, a bipolar-single polarity pulse, a single polarity-bipolar-single polarity pulse and a bipolar-single polarity-bipolar pulse.

The multi-mode high-voltage ultrashort pulse electric field generating module outputs single pulse, pulse train or pulse formed by combining single pulse and pulse train.

The pulse width output by the multimode high-voltage ultrashort pulse electric field generating module comprises nanoseconds, microseconds, microsecond-nanoseconds, nanosecond-microsecond, millisecond-microsecond, microsecond-millisecond-microsecond, microsecond-nanosecond, nanosecond-microsecond and millisecond-microsecond.

The pulse waveform output by the multi-mode high-voltage ultrashort pulse electric field generation module comprises a step rising waveform, a step falling waveform and a rising-falling waveform. Wherein the rising step or the falling step is 10% -50% of the pulse width.

The multi-mode high-voltage ultrashort pulse electric field generation module sends pulse excitation signals and monitoring signals to the atrial fibrillation treatment electrode through a cable, and sends telescopic control signals to the telescopic framework.

After the functional cable of the atrial fibrillation treatment electrode receives the pulse excitation signal, the functional cable sends a stimulation pulse signal to the treatment electrode, so that the treatment electrode applies treatment pulses to the target area, and the target area biological tissue is ablated.

And after the monitoring signal is received by the functional cable of the atrial fibrillation treatment electrode, a monitoring pulse signal is sent to the signal acquisition electrode.

the treatment pulse feedback signal acquisition electrode is used for acquiring a voltage signal and a current signal of treatment pulses applied by the treatment electrode and/or a voltage signal and a current signal of low-energy measurement pulses applied by the pulse application electrode, and transmitting the voltage signal and the current signal to the real-time monitoring module;

the length of the telescopic framework is adjusted according to the received telescopic control signal, so that the maximum cross-sectional area of the telescopic framework is matched with the target area.

The real-time monitoring module receives signals acquired by the signal acquisition electrode and sends the signals to the system controller, so that the system controller adjusts pulse parameters generated by the multi-mode high-voltage ultrashort pulse electric field generation module.

The real-time monitoring module comprises a pulse voltage and current acquisition monitoring unit and an electric excitation signal acquisition monitoring unit;

the pulse voltage and current acquisition monitoring unit receives the treatment pulse voltage signals and the treatment pulse current signals acquired by the signal acquisition electrode;

the pulse voltage and current acquisition monitoring unit receives a voltage signal and a current signal of a low-energy measurement pulse applied by the pulse application electrode at the gap of the treatment electrode for applying the treatment pulse;

the electric excitation signal acquisition monitoring unit receives the human body self electric stimulation signal acquired by the electric stimulation signal acquisition electrode.

The invention has the technical effects that the invention solves the problems of single treatment parameters and modes and incapability of monitoring the pulse action process in real time in the pulse ablation technology on the basis of overcoming the problems that the prior radio frequency and cryoablation ablate tissues and simultaneously easily form pulmonary vein stenosis, the subsequent balloon dilation and stent implantation treatment are required for causing the phrenic nerve injury and the like.

Drawings

FIG. 1 is a system module relationship diagram;

FIG. 2 is a system connection and relationship diagram;

FIG. 3 is a schematic diagram of a single pulse waveform;

FIG. 4 is a schematic diagram of a pulse train waveform;

FIG. 5 is a schematic diagram of a pulse train+monopulse waveform;

FIG. 6 is a schematic diagram of bipolar pulses;

FIG. 7 is a schematic diagram of a bipolar-unipolar monopulse;

FIG. 8 is a schematic diagram of a bipolar-unipolar pulse train;

FIG. 9 is a unipolar-bipolar-unipolar pulse train schematic;

FIG. 10 is a schematic diagram of a bipolar-unipolar-bipolar pulse train;

FIG. 11 (a) is a schematic diagram of microsecond-nanosecond-microsecond pulses;

FIG. 11 (b) is a nanosecond-microsecond-nanosecond pulse schematic diagram;

FIG. 12 (a) is a schematic diagram of a millisecond-microsecond-millisecond pulse;

FIG. 12 (b) is a microsecond-millisecond pulse schematic diagram;

FIG. 13 is a nanosecond-microsecond-millisecond pulse schematic diagram;

FIG. 14 is a schematic diagram of a millisecond-nanosecond-microsecond pulse;

FIG. 15 (a) is a nanosecond-microsecond pulse schematic; FIG. 15 (b) is a microsecond-millisecond pulse schematic;

FIG. 16 is a step up schematic;

FIG. 17 is a schematic view of a step down;

FIG. 18 is a schematic view of the steps up and down;

FIG. 19 is a front view of the therapeutic electrode of example 1;

FIG. 20 is a schematic view of the therapeutic electrode of example 1 in the X-direction;

FIG. 21 is a schematic view of the therapeutic electrode of example 1 in the Y-direction;

FIG. 22 is a top view of the therapeutic electrode of example 1 in the Z-direction;

FIG. 23 is a bottom view of the therapeutic electrode of example 1 in the Z-direction;

FIG. 24 is a detailed view I of the treatment electrode of example 1;

FIG. 25 is a detailed view II of the treatment electrode of example 1;

FIG. 26 is a front view of the therapeutic electrode of example 2;

FIG. 27 is a view showing the X direction of the therapeutic electrode of example 2;

FIG. 28 is a Y-direction of the therapeutic electrode of example 2;

FIG. 29 is a top view in the Z direction of the therapeutic electrode of example 2;

FIG. 30 is a bottom view of the therapeutic electrode of example 2 in the Z-direction;

FIG. 31 is a detailed view I of the treatment electrode of example 2;

FIG. 32 is a detailed view II of the treatment electrode of example 2;

in the figure: treatment pulse positive electrode I101, insulating layer I102, treatment pulse negative electrode I103, insulating layer II104, signal monitoring layer I105, insulating layer III106, sheath I107, electric telescopic rod 2, insulating support block 4, treatment pulse positive electrode II501, insulating layer IV502, treatment pulse negative electrode II503, insulating layer V504, signal monitoring layer II505, insulating layer VI506, sheath II507, telescopic branch frame I601, telescopic branch frame II602, pulse train a, single pulse B, bipolar C, unipolar D, microsecond E, nanosecond F, and millisecond G.

Detailed Description

The present invention is further described below with reference to examples, but it should not be construed that the scope of the above subject matter of the present invention is limited to the following examples. Various substitutions and alterations are made according to the ordinary skill and familiar means of the art without departing from the technical spirit of the invention, and all such substitutions and alterations are intended to be included in the scope of the invention.

Example 1:

referring to fig. 1 to 25, the multimode high-voltage ultrashort pulse electric field atrial fibrillation treatment electrode mainly comprises a functional cable, a telescopic framework, a ribbon wire, an action electrode and an insulating support coil.

The functional cable is a cylinder formed by multiple layers of telescopic layers, and is sequentially provided with a treatment pulse anode I101, an insulation layer I102, a treatment pulse cathode I103, an insulation layer II104, a signal monitoring layer I105, an insulation layer III106 and a sheath I107 from inside to outside.

The therapeutic pulse positive electrode I101 and the therapeutic pulse negative electrode I103 send a stimulating pulse signal to the therapeutic electrode 302 of the acting electrode through a lead. The therapeutic pulse positive electrode I101 and the therapeutic pulse negative electrode I103 are respectively and alternately connected with the therapeutic electrode 302.

The therapeutic pulse anode I101 is connected with the telescopic framework through a wire.

The insulating layer I102 is used for isolating the pulse positive electrode 101 and the treatment pulse negative electrode I103.

The insulating layer II104 is used for isolating the therapeutic pulse cathode I103 and the signal monitoring layer I105.

The signal monitoring layer I105 is a ribbon wire that is interposed between the insulating layer II104 and the insulating layer III 106. The signal monitoring layer I105 is connected to the signal collecting electrode 301 of the active electrode, so as to send a monitoring pulse signal to the signal collecting electrode 301. The electrode is umbrella-shaped electrode, the monitoring layer is a strip wire which is closely arranged and is connected with the signal acquisition electrode, so that the telescopic framework of the umbrella-shaped electrode is correspondingly connected with the treatment pulse layer and alternately connected with the positive electrode and the negative electrode. And the detection layer is connected with the corresponding signal acquisition electrode.

The insulating layer III106 is used for isolating the signal monitoring layer I105 and the outer skin I107.

The sheath I107 is used to protect the functional cable.

The telescopic framework comprises a plurality of electric telescopic rods 2.

One end of any electric telescopic rod 2 is fixed on the outer side wall of the outer skin I107, and the other end is adhered with the side wall of the insulating support block 4. The electric telescopic rods 2 are in one-to-one correspondence with the insulating supporting blocks 4.

All the electric telescopic rods 2 are arranged in an umbrella shape with the outer skin I107 as a center.

The length of the motorized telescopic rod 2 is the shortest before the active electrode is inserted into the target area. After the electric telescopic rod 2 receives the telescopic signal sent by the therapeutic pulse anode I101 through the lead, the length is changed, so that the maximum cross section area of the telescopic framework I2 is matched with the target area.

The active electrode is inserted into the target area. The telescopic framework is electrically connected with the therapeutic pulse anode I101. The electric telescopic rod 2 is an electric device.

The active electrodes include a number of signal acquisition electrodes 301 and a number of treatment electrodes 302. The signal acquisition electrodes 301 and the therapy electrodes 302 are alternately arranged.

The signal acquisition electrode 301 includes a plurality of electrical stimulation signal acquisition electrodes, a plurality of therapeutic pulse feedback signal acquisition electrodes, and a plurality of pulse application electrodes. Each signal acquisition electrode can be used as an electrical stimulation signal acquisition electrode, a therapeutic pulse feedback signal acquisition electrode or a pulse application electrode, and is specifically controlled by a system controller.

The electric stimulation signal acquisition electrode is used for acquiring electric stimulation signals of the human body.

The therapeutic pulse feedback signal acquisition electrode is configured to acquire a voltage signal and a current signal of a therapeutic pulse applied by the therapeutic electrode 302 and/or a voltage signal and a current signal of a low-energy measurement pulse applied by the pulse application electrode.

The pulse application electrode applies a low energy measurement pulse to the target volume in the gap between the application of the treatment pulse by the treatment electrode 302. The low-energy measurement pulse signal is a unipolar pulse, the voltage amplitude is 10-50V, the pulse width is 1-50 us, and the repetition frequency range is 0.01-10 Hz.

That is, the signal acquisition electrode 301 has three modes of operation, mode one: the electrical stimulation signal of the human body is monitored to confirm whether the abnormal electrical stimulation signal causing the atrial fibrillation exists. Mode two: and collecting feedback signals of the therapeutic pulses, measuring voltage and current signals of the therapeutic pulses at the moment, and optionally switching the voltage and the measuring currents of the signal collecting electrodes according to the therapeutic needs of the controller. Mode three: and actively applying the small measurement pulse, namely applying the small measurement pulse by a plurality of signal acquisition electrodes in a treatment pulse application gap, and simultaneously acquiring feedback signals of the small measurement pulse by the plurality of signal acquisition electrodes in real time, wherein the functions of the signal acquisition electrodes can be freely switched according to a controller.

The therapy electrode 302 applies a therapeutic pulse to the target area to complete ablation of biological tissue of the target area.

The therapy electrodes 302 apply the therapy pulses simultaneously. The plurality of signal electrodes 301 collect the target area electrical stimulation signal and the therapeutic pulse signal of the therapeutic electrode 302 independently or simultaneously.

The therapeutic electrode 302 and the signal acquisition electrode 301 are both cylinders with rounded tops. The tip is the end that is inserted into the target area.

The insulating support coil comprises insulating support blocks 4 the same as the number of the electric telescopic rods 2.

One end of any insulating support block 4 is adhered with a signal acquisition electrode 301, and the other end is adhered with a treatment electrode 302, so that the signal acquisition electrode 301, the insulating support block 4 and the treatment electrode 302 form a closed circular ring.

The insulating support block 4 is used for avoiding short circuit of active electrodes and ensuring that the distance between adjacent electrodes is not lower than a threshold value d.

The electrode enters the target area through the vein, the electrode is unfolded, then a treatment pulse is applied, after the anatomical connection of the pulmonary vein sleeve and the atrium is isolated, the electrode is reset, and finally the whole electrode is extracted.

Example 2:

referring to fig. 1 to 18, fig. 26 to 32, the multimode high-voltage ultrashort pulse electric field atrial fibrillation treatment electrode mainly comprises a functional cable, a telescopic framework, a lead and an action electrode.

The functional cable is a cylinder formed by multiple layers of telescopic layers, and is formed by a treatment pulse positive electrode II501, an insulation layer IV502, a treatment pulse negative electrode II503, an insulation layer V504, a signal monitoring layer II505, an insulation layer VI506 and a sheath II507 from inside to outside in sequence.

The therapeutic pulse positive electrode II501 and the therapeutic pulse negative electrode II503 send a stimulating pulse signal to the therapeutic electrode 302 of the acting electrode through a lead. The therapeutic pulse positive electrode II501 and the therapeutic pulse negative electrode II503 are respectively and alternately connected with the therapeutic electrode 302.

The therapeutic pulse positive electrode II501 is connected with the telescopic framework through a wire.

The insulating layer IV502 is used to isolate the pulse positive electrode 501 from the therapeutic pulse negative electrode II503.

The insulating layer V504 is used for isolating the therapeutic pulse cathode II503 from the signal monitoring layer II505.

The signal monitoring layer II505 is a ribbon wire that is interposed between the insulating layer IV502 and the insulating layer V504. The signal monitoring layer II505 is connected with the signal collecting electrode 301 of the action electrode, so as to send a monitoring pulse signal to the signal collecting electrode 301. The electrode of the embodiment is a spherical electrode, the monitoring layer is a strip wire which is tightly arranged and is connected with the signal acquisition electrode, so that the white telescopic framework of the spherical electrode is correspondingly connected with the treatment pulse layer and alternately connected with the positive electrode and the negative electrode. And the detection layer is connected with the corresponding signal acquisition electrode.

The insulating layer VI506 is used to isolate the signal monitoring layer II505 from the skin II507.

The sheath II507 is used to protect the functional cable.

The telescopic framework comprises a plurality of electric telescopic brackets. Any telescopic bracket comprises a telescopic branch bracket I601, a telescopic branch bracket II602 and 2 insulating blocks. The electric telescopic bracket is electrically connected with the therapeutic pulse positive electrode II 501.

One end of the telescopic branch frame I601 is fixed on the outer skin II507, and the other end is adhered with an insulating block.

One end of the telescopic branch frame II602 is fixed on the signal monitoring layer II505, and the other end is bonded with an insulating block.

The signal acquisition electrode 301 or the treatment electrode 302 is adhered between the 2 insulating blocks, so that the signal acquisition electrode 301 or the treatment electrode 302, the telescopic branch frame I601, the telescopic branch frame II602 and the 2 insulating blocks form an arc shape.

All the telescopic supports are circumferentially arranged around the outer side wall of the outer skin II507.

Before the action electrode is inserted into the target area, all the electric telescopic brackets are attached with functional cables. After the electric telescopic bracket receives a telescopic signal sent by the therapeutic pulse anode II501 through a lead, the arc length is changed, the curvature of the arc line is increased, but the linear distance between two endpoints of the arc line is unchanged, so that the maximum cross section area of the telescopic bracket is matched with the target area.

The active electrode is inserted into the target area. The number of the action electrodes is 8-32.

The signal acquisition electrode 301 includes a plurality of electrical stimulation signal acquisition electrodes, a plurality of therapeutic pulse feedback signal acquisition electrodes, and a plurality of pulse application electrodes.

Example 3:

the therapeutic equipment with the multimode high-voltage ultrashort pulse electric field atrial fibrillation therapeutic electrode mainly comprises a system controller, a multimode high-voltage ultrashort pulse electric field generating module, an atrial fibrillation therapeutic electrode, a real-time monitoring module and a handle.

The pulse width output by the multimode high-voltage ultrashort pulse electric field generating module comprises nanoseconds, microseconds or random combination of nanoseconds, microseconds and milliseconds, and mainly comprises nanoseconds, microseconds-nanoseconds, nanoseconds-microseconds-nanoseconds, milliseconds-microseconds-milliseconds, milliseconds-milliseconds, nanoseconds-milliseconds, milliseconds-nanoseconds, milliseconds-milliseconds, and milliseconds-milliseconds.

The voltage amplitude is 2-10 times different in combination, and if the millisecond voltage amplitude is 1 in nanosecond, microsecond and millisecond combination, the microsecond voltage amplitude is 2-10, and the nanosecond voltage amplitude is 4-100.

After the functional cable of the atrial fibrillation treatment electrode receives the pulse excitation signal, the functional cable sends a stimulation pulse signal to the treatment electrode 302, so that the treatment electrode 302 applies treatment pulses to the target area to complete the ablation of biological tissues of the target area.

After the functional cable of the atrial fibrillation treatment electrode receives the monitoring signal, the monitoring pulse signal is sent to the signal acquisition electrode 301.

The therapeutic pulse feedback signal collection electrode is configured to collect a voltage signal and a current signal of a therapeutic pulse applied by the therapeutic electrode 302 and/or a voltage signal and a current signal of a low-energy measurement pulse applied by the pulse application electrode, and send the signals to the real-time monitoring module.

The real-time monitoring module comprises a pulse voltage and current acquisition monitoring unit and an electric excitation signal acquisition monitoring unit.

The pulse voltage and current collection monitoring unit receives the therapeutic pulse voltage signal and the therapeutic pulse current signal collected by the signal collection electrode 301.

The pulse voltage and current acquisition monitoring unit receives the voltage signal and the current signal of the low-energy measurement pulse applied by the pulse application electrode at the gap where the treatment pulse is applied by the treatment electrode 302.

The electric excitation signal acquisition monitoring unit receives the human body self electric stimulation signal acquired by the electric stimulation signal acquisition electrode, namely the electric excitation signal of the pulmonary vein sleeve of the target area.

The handle controls the length of the telescopic framework through keys.

Claims

1. The multimode high-voltage ultrashort pulse electric field atrial fibrillation treatment electrode is characterized in that: comprises a functional cable, a telescopic framework, a wire, an action electrode and an insulating support coil;

the functional cable is a cylinder formed by multiple layers of telescopic layers, and is sequentially provided with a treatment pulse anode I (101), an insulating layer I (102), a treatment pulse cathode I (103), an insulating layer II (104), a signal monitoring layer I (105), an insulating layer III (106) and a sheath I (107) from inside to outside;

the therapeutic pulse positive electrode I (101) and the therapeutic pulse negative electrode I (103) send a stimulating pulse signal to the therapeutic electrode (302) of the action electrode through a lead; the therapeutic pulse positive electrode I (101) and the therapeutic pulse negative electrode I (103) are respectively and alternately connected with the therapeutic electrode (302);

the treatment pulse anode I (101) is connected with the telescopic framework through a lead;

the insulating layer I (102) is used for isolating the therapeutic pulse anode (101) and the therapeutic pulse cathode I (103);

the insulating layer II (104) is used for isolating the therapeutic pulse negative electrode I (103) and the signal monitoring layer I (105);

the signal monitoring layer I (105) is a ribbon wire which is stuck between the insulating layer II (104) and the insulating layer III (106); the signal monitoring layer I (105) is connected with the signal acquisition electrode (301) of the action electrode, so that a monitoring pulse signal is sent to the signal acquisition electrode (301);

the insulating layer III (106) is used for isolating the signal monitoring layer I (105) and the outer skin I (107);

the sheath I (107) is used for protecting the functional cable;

the telescopic framework comprises a plurality of electric telescopic rods (2);

one end of any electric telescopic rod (2) is fixed on the outer side wall of the outer skin I (107), and the other end is adhered with the side wall of the insulating support block (4); the electric telescopic rods (2) are in one-to-one correspondence with the insulating supporting blocks (4);

all the electric telescopic rods (2) are arranged in an umbrella shape by taking the outer skin I (107) as the center;

the action electrode is inserted into the target area;

the action electrode comprises a plurality of signal acquisition electrodes (301) and a plurality of treatment electrodes (302); the signal acquisition electrodes (301) and the treatment electrodes (302) are alternately arranged;

the signal acquisition electrode (301) comprises a plurality of electric stimulation signal acquisition electrodes, a plurality of treatment pulse feedback signal acquisition electrodes and a plurality of pulse application electrodes;

the therapeutic pulse feedback signal acquisition electrode is used for acquiring a voltage signal and a current signal of therapeutic pulses applied by the therapeutic electrode (302) and/or a voltage signal and a current signal of low-energy measurement pulses applied by the pulse application electrode;

the pulse application electrode applies a measurement pulse to the target region in the gap between the treatment electrode (302) and the treatment pulse;

the treatment electrode (302) applies treatment pulses to the target area to complete the ablation of biological tissues of the target area;

the insulation support coils comprise insulation support blocks (4) the same as the electric telescopic rods (2);

one end of any insulating support block (4) is adhered with the signal acquisition electrode (301), and the other end is adhered with the treatment electrode (302), so that the signal acquisition electrode (301), the insulating support block (4) and the treatment electrode (302) form a closed pattern.

2. The multimode high-voltage ultrashort pulse electric field atrial fibrillation treatment electrode according to claim 1, characterized in that the length of the electric telescopic rod (2) is the shortest before the action electrode is inserted into the target area; after the electric telescopic rod (2) receives a telescopic signal sent by the therapeutic pulse anode I (101) through a lead, the length of the electric telescopic rod is changed, and the maximum cross section area of the telescopic framework is matched with a target area.

3. The multimode, high voltage, ultrashort pulse, electric field atrial fibrillation treatment electrode of claim 1, wherein: the insulating support block (4) is used for avoiding short circuit of the active electrodes and ensuring that the distance between the adjacent electrodes is not lower than a threshold value d.

4. The multimode high-voltage ultrashort pulse electric field atrial fibrillation treatment electrode is characterized in that: comprises a functional cable, a telescopic framework, a wire and an action electrode;

the functional cable is a cylinder formed by multiple layers of telescopic layers, and is sequentially provided with a treatment pulse anode II (501), an insulating layer IV (502), a treatment pulse cathode II (503), an insulating layer V (504), a signal monitoring layer II (505), an insulating layer VI (506) and a sheath II (507) from inside to outside;

the therapeutic pulse positive electrode II (501) and the therapeutic pulse negative electrode II (503) send a stimulating pulse signal to the therapeutic electrode (302) of the action electrode through a lead; the therapeutic pulse positive electrode II (501) and the therapeutic pulse negative electrode II (503) are respectively and alternately connected with the therapeutic electrode (302);

the therapeutic pulse anode II (501) is connected with the telescopic framework through a lead;

the insulating layer IV (502) is used for isolating a therapeutic pulse positive electrode (501) and a therapeutic pulse negative electrode II (503);

the insulating layer V (504) is used for isolating the therapeutic pulse cathode II (503) and the signal monitoring layer II (505);

the signal monitoring layer II (505) is a ribbon wire which is stuck between the insulating layer IV (502) and the insulating layer V (504); the signal monitoring layer II (505) is connected with the signal acquisition electrode (301) of the action electrode, so as to send a monitoring pulse signal to the signal acquisition electrode (301);

the insulating layer VI (506) is used for isolating the signal monitoring layer II (505) and the outer skin II (507);

the sheath II (507) is used for protecting the functional cable;

the telescopic framework comprises a plurality of electric telescopic brackets; any telescopic bracket comprises a telescopic branch bracket I (601), a telescopic branch bracket II (602) and 2 insulating blocks;

one end of the telescopic branch frame I (601) is fixed on the outer skin II (507), and the other end is adhered with an insulating block;

one end of the telescopic branch frame II (602) is fixed on the signal monitoring layer II (505), and the other end is adhered with an insulating block;

the signal acquisition electrode (301) or the treatment electrode (302) is adhered between the 2 insulating blocks, so that the signal acquisition electrode (301) or the treatment electrode (302) forms an arc line with the telescopic branch frame I (601), the telescopic branch frame II (602) and the 2 insulating blocks;

all the telescopic supports are circumferentially arranged around the outer side wall of the outer skin II (507);

the action electrode is inserted into the target area;

the pulse application electrode applies a low energy measurement pulse to the target region in the gap between the treatment electrode (302) and the treatment pulse;

the therapy electrode (302) applies a therapeutic pulse to the target area to complete ablation of biological tissue of the target area.

5. The multimode, high voltage, ultrashort pulse, electric field atrial fibrillation treatment electrode of claim 4, further comprising: before the action electrode is inserted into the target area, all the electric telescopic brackets are attached with functional cables; after the electric telescopic bracket receives a telescopic signal sent by the therapeutic pulse positive electrode II (501) through a lead, the arc length is changed, so that the maximum cross section area of the telescopic bracket is matched with a target area.

6. The multi-mode high voltage ultrashort pulse electric field atrial fibrillation treatment electrode of claim 1 or 4, characterized in that the treatment electrode (302) applies treatment pulses simultaneously; the plurality of signal acquisition electrodes (301) acquire the target area electrical stimulation signals and the treatment pulse signals of the treatment electrodes (302) independently or simultaneously.

7. The multimode high voltage ultrashort pulse electric field atrial fibrillation treatment electrode of claim 1 or 4, characterized in that: the treatment electrode (302) and the signal acquisition electrode (301) are both cylinders with rounded tops; the tip is the end that is inserted into the target area.

8. A therapeutic apparatus, characterized in that: the system comprises a system controller, a multi-mode high-voltage ultra-short pulse electric field generation module, a real-time monitoring module and the multi-mode high-voltage ultra-short pulse electric field atrial fibrillation treatment electrode according to claim 1 or 4;

the system controller controls pulse parameters generated by the multi-mode high-voltage ultrashort pulse electric field generation module;

the multi-mode high-voltage ultrashort pulse electric field generation module sends pulse excitation signals and monitoring signals to the atrial fibrillation treatment electrode through the functional cable and sends telescopic control signals to the telescopic framework;

after the functional cable of the atrial fibrillation treatment electrode receives the pulse excitation signal, the functional cable sends a stimulation pulse signal to the treatment electrode (302) to enable the treatment electrode (302) to apply treatment pulses to the target area so as to complete the ablation of biological tissues of the target area;

after the functional cable of the atrial fibrillation treatment electrode receives the monitoring signal, the monitoring pulse signal is sent to the signal acquisition electrode (301);

the treatment pulse feedback signal acquisition electrode is used for acquiring a voltage signal and a current signal of treatment pulses applied by the treatment electrode (302) and/or a voltage signal and a current signal of low-energy measurement pulses applied by the pulse application electrode, and transmitting the voltage signal and the current signal to the real-time monitoring module;

the pulse application electrode applies a measurement pulse to the target region in the gap between the treatment electrode (302) and the treatment pulse; the measuring pulse signal is unipolar pulse, and the voltage amplitude is 10V _～ 50V, pulse width 1us _～ 50us, a repetition frequency in the range of 0.01Hz _～ 10Hz；

The length of the telescopic framework is adjusted according to the received telescopic control signal, so that the maximum cross-sectional area of the telescopic framework is matched with the target area;

9. The therapeutic apparatus of claim 8, wherein: the voltage amplitude range of the output pulse of the multi-mode high-voltage ultra-short pulse electric field generating module is [0, 8000V ], and the pulse width range is [100ns,10ms ];

the pulse output by the multi-mode high-voltage ultrashort pulse electric field generating module comprises a single polarity pulse, a bipolar pulse, a single polarity-bipolar pulse, a bipolar-single polarity pulse, a single polarity-bipolar-single polarity pulse and a bipolar-single polarity-bipolar pulse;

the multi-mode high-voltage ultrashort pulse electric field generation module outputs single pulse, pulse train or pulse formed by combining single pulse and pulse train;

the pulse width output by the multimode high-voltage ultrashort pulse electric field generation module comprises single nanosecond, single microsecond or random combination of microsecond, nanosecond and millisecond;

the pulse waveform output by the multi-mode high-voltage ultrashort pulse electric field generation module comprises a step rising waveform, a step falling waveform and a rising-falling waveform; wherein the rising step or the falling step is 10% of the pulse width _～ 50％。

10. The therapeutic apparatus of claim 8, wherein: the real-time monitoring module comprises a pulse voltage and current acquisition monitoring unit and an electric excitation signal acquisition monitoring unit;

the pulse voltage and current acquisition monitoring unit receives treatment pulse voltage signals and current signals acquired by the signal acquisition electrode (301);

the pulse voltage and current acquisition monitoring unit receives voltage signals and current signals of measurement pulses applied by the pulse application electrode at the gap where the treatment pulses are applied by the treatment electrode (302);