阅读说明：本技术 一种用于心脏消融的正弦包络高压脉冲输出方法 (Sinusoidal envelope high-voltage pulse output method for cardiac ablation ) 是由 黄雍俊 于 2019-09-29 设计创作，主要内容包括：本发明公开了心脏消融设备技术领域的一种用于心脏消融的包络正弦高压脉冲输出方法。方法的步骤包括：1、生成双极性的高压脉冲信号,所述高压脉冲信号的脉宽为毫秒级、微秒级或纳秒级；2、将所述双极性的高压脉冲信号与正弦包络信号叠加,生成正弦包络高压脉冲信号,所述正弦包络高压脉冲信号用于心脏消融能量的输出。采用本发明的方法,使得输出的高压脉冲是具有包络的正弦信号的高压脉冲,进而可以根据此包络正弦频率进行滤波,从而减小高压脉冲对其他信号的干扰。同时,保持了高压脉冲的特性,高压脉冲消融的全层消融、精准、快速、保护冠脉的特点也能得到保持。(The invention discloses an envelope sine high-voltage pulse output method for cardiac ablation, belonging to the technical field of cardiac ablation equipment. The method comprises the following steps: 1. generating a bipolar high-voltage pulse signal, wherein the pulse width of the high-voltage pulse signal is millisecond, microsecond or nanosecond; 2. and superposing the bipolar high-voltage pulse signal and a sinusoidal envelope signal to generate a sinusoidal envelope high-voltage pulse signal, wherein the sinusoidal envelope high-voltage pulse signal is used for outputting cardiac ablation energy. By adopting the method, the output high-voltage pulse is the high-voltage pulse of the envelope sine signal, and the filtering can be carried out according to the envelope sine frequency, so that the interference of the high-voltage pulse on other signals is reduced. Meanwhile, the characteristics of high-voltage pulse are kept, and the characteristics of full-layer ablation, accuracy and rapidness and coronary artery protection of the high-voltage pulse ablation can also be kept.)

1. A method of outputting sinusoidal envelope high voltage pulses for cardiac ablation, comprising the steps of: generating a bipolar high-voltage pulse signal, wherein the pulse width of the high-voltage pulse signal is millisecond, microsecond or nanosecond;

and superposing the bipolar high-voltage pulse signal and a sinusoidal envelope signal to generate a sinusoidal envelope high-voltage pulse signal, wherein the sinusoidal envelope high-voltage pulse signal is used for outputting cardiac ablation energy.

2. The method as claimed in claim 1, wherein the bipolar high voltage pulse signal has adjustable high voltage pulse width, high voltage pulse interval, high voltage pulse number and high voltage pulse amplitude, so that the output electric field energy in each period of the sinusoidal envelope high voltage pulse signal is adjustable.

3. The method of claim 1, wherein the bipolar high voltage pulse signal has an amplitude in the range of 300V-15 KV.

4. The method of outputting sinusoidal envelope high voltage pulses for cardiac ablation of claim 1, wherein the frequency range of the sinusoidal envelope signal is: 1Hz to 20 MHz.

5. The method of outputting sinusoidal envelope high voltage pulses for cardiac ablation according to any one of claims 1-4, wherein the sinusoidal envelope high voltage pulse signal includes a plurality of basic pulse groups, the basic pulse groups including positive high voltage pulse groups, negative high voltage pulse groups, positive and negative high voltage pulse groups,

the pulse signal forming the positive high-voltage pulse group is a positive high-voltage pulse signal;

the pulse signal forming the negative high-voltage pulse group is a negative high-voltage pulse signal;

the pulse signals forming the positive and negative high-voltage pulse groups are positive high-voltage pulse signals and negative high-voltage pulse signals.

6. The method of claim 5, wherein the time interval between said plurality of basic pulse groups is more than 10 times the interval time of said bipolar high voltage pulse signal high voltage pulse.

7. A method of outputting sinusoidal envelope high voltage pulses for cardiac ablation according to claim 6, wherein the sinusoidal envelope high voltage pulse signal is output only during the absolute refractory period of the heart, the step of outputting the sinusoidal envelope high voltage pulse signal comprising:

detecting electrophysiological signals of the heart;

when the heart is detected to be in the refractory period, a sinusoidal envelope high voltage pulse signal is output.

8. A method of outputting sinusoidal envelope high voltage pulses for cardiac ablation as in claim 7, wherein the method of detecting the absolute refractory period comprises: the autonomic rhythm uses R wave sensing absolute refractory period detection method, and pacing technology to generate pacing rhythm and combines R wave sensing to realize absolute refractory period detection.

9. A method of sinusoidal envelope high voltage pulse output for cardiac ablation as in claim 8, wherein the method steps of producing a paced rhythm using pacing techniques and implementing absolute refractory period detection in conjunction with R-wave sensing comprise:

inputting a pacing signal to generate a pacing rhythm;

sensing the paced rhythm via an R-wave;

determining the moment when the R wave is detected as the period starting moment of the paced rhythm;

the delay period Tdelay2 from the start of cycle time of the paced rhythm is followed by the start of the absolute refractory period, which is T2 in duration.

10. A sinusoidal envelope high-voltage pulse output system for cardiac ablation is characterized by comprising a high-voltage pulse signal generation unit, a refractory period detection module, an output catheter, at least one processor and a memory which is in communication connection with the at least one processor; the memory stores instructions executable by the at least one processor to enable the at least one processor to perform the method of any one of claims 1-9.

Technical Field

The invention relates to the technical field of cardiac ablation equipment, in particular to a sinusoidal envelope high-voltage pulse output method for cardiac ablation.

Background

The existing technology for treating tachyarrhythmia usually adopts radiofrequency, microwave, freezing and other thermal ablation technologies. Wherein the radio frequency technology can generate a sine wave of fixed frequency. The generated radio frequency energy acts on the focus point needing to be treated through the radio frequency catheter or the radio frequency electrode, so that the effect of blocking or conditioning is achieved, and the treatment effect is further achieved.

However, these ablation techniques are limited by the heat sink effect in clinical practice, and it is difficult to achieve the full-thickness transmural ablation target, thereby affecting the therapeutic effect.

In view of the above drawbacks of thermal ablation techniques, high voltage pulse technology is gaining attention as an atherectomy technique. The high-voltage pulse technology is to generate a high-voltage pulse electric field with the pulse width of millisecond, microsecond or even nanosecond, to release extremely high energy in a short time, so that a large number of irreversible micropores can be generated in a cell membrane or even intracellular organelles such as endoplasmic reticulum, mitochondria, cell nucleus and the like. Further causing the apoptosis of the pathological cells, thereby achieving the expected treatment purpose.

In the application of treating the tachyarrhythmia, the high-voltage pulse technology can be used for selectively treating the myocardial cells without influencing other non-target cell tissues, and meanwhile, the high-voltage pulse technology has the characteristics of complete full-layer ablation, accuracy, rapidness and coronary artery protection. Therefore, the high-voltage pulse technology is expected to become an ideal cardiac ablation means.

Although the high-voltage pulse technology has the advantages, the strong interference of the high-voltage pulse often affects useful signals such as electrophysiology, magnetic positioning, pressure detection and the like in the minimally invasive cardiac surgery, and further affects the judgment of a doctor in the surgery. The fitting degree of the system catheter and the myocardial tissue can also influence the treatment effect, and the existing system and equipment do not consider the two points.

Disclosure of Invention

The present invention is directed to overcoming the above-mentioned deficiencies in the prior art and providing a sinusoidal envelope high voltage pulse output method for cardiac ablation.

In order to achieve the above purpose, the invention provides the following technical scheme:

a method of sinusoidal envelope high voltage pulse output for cardiac ablation, the steps comprising:

generating a bipolar high-voltage pulse signal, wherein the pulse width of the high-voltage pulse signal is millisecond, microsecond or nanosecond;

and superposing the bipolar high-voltage pulse signal and the sinusoidal envelope signal to generate a sinusoidal envelope high-voltage pulse signal, wherein the sinusoidal envelope high-voltage pulse signal is used for outputting the cardiac ablation energy.

Furthermore, the high-voltage pulse width, the high-voltage pulse interval, the high-voltage pulse number and the high-voltage pulse amplitude of the bipolar high-voltage pulse signal are adjustable, so that the energy of an electric field output in each period of the output sinusoidal envelope high-voltage pulse signal is adjustable.

Preferably, the amplitude range of the bipolar high-voltage pulse signal is 300V-15 KV.

Preferably, the frequency range of the sinusoidal envelope signal is: 1Hz to 20 MHz.

Furthermore, the sinusoidal envelope high voltage pulse signal comprises a plurality of basic pulse groups, the basic pulse groups comprise a positive high voltage pulse group, a negative high voltage pulse group and a positive and negative high voltage pulse group,

the pulse signal forming the positive high-voltage pulse group is a positive high-voltage pulse signal;

the pulse signal forming the negative high-voltage pulse group is a negative high-voltage pulse signal;

the pulse signals forming the positive and negative high-voltage pulse groups are positive high-voltage pulse signals and negative high-voltage pulse signals.

Preferably, the time interval between the plurality of basic pulse groups is 10 times or more the high-voltage pulse interval time of the bipolar high-voltage pulse signal.

Further, the sinusoidal envelope high voltage pulse signal is output only during the absolute refractory period of the heart, and the step of outputting the sinusoidal envelope high voltage pulse signal includes:

detecting electrophysiological signals of the heart;

when the heart is detected to be in the refractory period, a sinusoidal envelope high voltage pulse signal is output.

Further, the method for detecting the absolute refractory period comprises the following steps: the autonomic rhythm uses R wave sensing absolute refractory period detection method, and pacing technology to generate pacing rhythm and combines R wave sensing to realize absolute refractory period detection.

Further, the method for generating the paced heart rhythm by using the pacing technology and realizing the absolute refractory period detection by combining the R wave perception comprises the following steps:

inputting a pacing signal to generate a pacing rhythm;

sensing a paced rhythm via an R-wave;

determining the moment when the R wave is detected as the period starting moment of the paced rhythm;

the time period Tdelay2 is delayed from the start of the cycle of the paced heart rhythm by the start of the absolute refractory period, which has a duration T2.

A sinusoidal envelope high-voltage pulse output system for cardiac ablation comprises a high-voltage pulse signal generation unit, a refractory period detection module, an output catheter, at least one processor and a memory which is in communication connection with the at least one processor; the memory stores instructions executable by the at least one processor to enable the at least one processor to perform the method of any one of the above.

Compared with the prior art, the invention has the beneficial effects that:

1. by adopting the method, the output high-voltage pulse is the high-voltage pulse of the sinusoidal signal with the envelope, and the system can filter according to the sinusoidal frequency of the envelope, so that the interference of the high-voltage pulse on the useful signal is reduced.

2. The output sinusoidal envelope pulse wave still keeps the characteristics of high-voltage pulse, the output of high-voltage pulse energy can be controlled by adjusting parameters, and the advantages of full-layer ablation, accuracy, rapidness and coronary artery protection can be realized.

3. The output sinusoidal envelope high voltage pulse signal comprises a positive high voltage pulse group, a negative high voltage pulse group, a positive and negative high voltage pulse group and a combination thereof. The composition and parameters of the sinusoidal envelope high-voltage pulse signal can be flexibly set so as to be suitable for practical use.

4. On the basis of a sine envelope high-voltage pulse output method for cardiac ablation, a method for generating a pacing rhythm by using a pacing technology and realizing absolute refractory period detection by combining R wave sensing is provided, so that single complete ablation energy output is completed in the absolute refractory period, and the output safety is ensured.

Description of the drawings:

FIG. 1 is a flow chart of a sinusoidal envelope high voltage pulse output method for cardiac ablation in accordance with the present invention;

FIG. 2 is a graph of the sinusoidal envelope of a single complete positive pulse in example 1;

FIG. 3 is a single complete negative pulse sinusoidal envelope of example 1;

FIG. 4 is a single complete positive and negative pulse sinusoidal envelope of example 1;

FIG. 5 is a diagram of a basic pulse group consisting of 2 complete sinusoidal envelopes of positive pulses in example 1;

FIG. 6 is a diagram of a basic pulse group consisting of 2 complete negative pulse sinusoidal envelopes in example 1;

FIG. 7 is a diagram of a basic pulse group consisting of 2 complete sinusoidal envelopes of positive and negative pulses in example 1;

fig. 8 is a schematic diagram of absolute refractory period detection using R-wave sensing for spontaneous heart rhythms in example 1;

FIG. 9 is a schematic diagram of the pacing rhythm generated by the pacing technology and the absolute refractory period detection realized by the R-wave sensing in embodiment 1;

fig. 10 is a graph of single ablation energy output consisting of multiple basal pulse bursts in example 1.

Detailed Description

The present invention will be described in further detail with reference to test examples and specific embodiments. It should be understood that the scope of the above-described subject matter is not limited to the following examples, and any techniques implemented based on the disclosure of the present invention are within the scope of the present invention.