CN114903585A - A pulsed electric field ablation device and method of using the same - Google Patents

Abstract

The invention belongs to the field of medical instruments, and discloses pulsed electric field ablation equipment and a using method thereof, wherein the pulsed electric field ablation equipment comprises the following steps: the ablation device comprises a positioning catheter and a pulse ablation catheter, wherein a catheter body of the positioning catheter is hollow and comprises an arc-shaped tail end catheter body and a lumen, and the ablation device further comprises an auxiliary device intravascular ultrasonic catheter capable of moving in the lumen. The invention can realize the minimally invasive treatment of the myocardial bridge, particularly the treatment by combining with an intravascular ultrasound catheter (IVUS), and can accurately, efficiently and less-side-effect solve the clinical problem of the myocardial bridge.

Description

A pulsed electric field ablation device and method of using the same

technical field

The invention relates to the field of medical instruments, in particular to a pulsed electric field ablation device and a method for using the same.

Background technique

The part of the coronary artery that runs inside the myocardial tissue is called intramyocardial coronary artery (ICA), and the corresponding myocardial tissue covering it is compressed on the surface of the ICA in a bridge-like manner, which is called coronary myocardial bridge (myocardial bridge). This myocardial bridge compresses the ICA during systole and can last until late diastole, reducing the blood supply to the ICA. Autopsy data confirmed that the incidence of myocardial bridge was 40% to 80%. The proximal end of myocardial bridge is easy to combine with coronary atherosclerosis, leading to myocardial ischemia, inducing arrhythmia, myocardial blunt depression, abnormal left ventricular function, syncope and even sudden death. There are various diagnostic techniques for myocardial bridge, and imaging diagnosis is mainly through coronary angiography, intravascular ultrasonography (IVUS), CT angiography and other examination methods.

At present, there is no minimally invasive treatment for myocardial bridges. For symptomatic patients with myocardial bridges, drug therapy and non-drug therapy are currently used. Non-drug treatments mainly include interventional therapy, coronary artery bypass grafting and muscle bridge release. Interventional therapy will lead to complications such as long-term stent restenosis, coronary perforation, and stent rupture; the main problem of coronary artery bypass grafting is the blood flow competition between the bypass and the coronary arteries, and requires large surgical trauma; Bridge release requires large surgical trauma, and may be complicated by ventricular perforation, surgical scar recompression of coronary arteries and other adverse events.

Pulsed electric field ablation refers to the application of high-voltage electrical pulses to the phospholipid bilayer of the cell membrane in a short period of time, resulting in the formation of a transmembrane potential, thereby generating an unstable potential and causing irreversible penetrating damage to the cell membrane (ie, irreversible electroporation). ), resulting in nanoscale pores, leading to changes in cell membrane permeability, disrupting the homeostasis of the intracellular environment, and ultimately leading to apoptosis.

Pulsed electric field ablation has the following characteristics: (1) Pulsed electric field ablation can preserve extracellular matrix. (2) The ablation threshold is tissue-specific, so that certain specific tissues (such as myocardium) can be specifically ablated. Myocardial tissue has a lower ablation threshold than many other tissues, allowing cardiomyocytes to be ablated while avoiding damage to adjacent tissues (eg, blood vessels, nerves, esophagus). (3) Compared with traditional radiofrequency ablation, pulsed electric field ablation can cause extensive myocardial damage without relying on the adhesion of the catheter. (4) The ablation rate of pulsed electric field is extremely fast, often in milliseconds or even smaller.

Animal experiments using pulsed electric field ablation on coronary arteries show that no obvious damage to coronary arteries is caused under the ablation energy that can cause deep myocardial lesions, and no lumen stenosis is found in short-term (3 weeks) or long-term (3 months) follow-up. . The use of pulsed electric field ablation thresholds has the characteristics of tissue specificity, and intracoronary pulsed electric field ablation of myocardial bridges is an ideal treatment method. At present, pulse ablation on the market has applications in atrial fibrillation and tumor treatment, and the instruments used cannot be operated in coronary arteries, nor can it be used in combination with IVUS.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a device for pulse ablation of myocardial bridges in coronary arteries in view of the problems of large surgical trauma and postoperative complications in the prior art, and to release a suitable pulsed electric field to release myocardial bridges, There was no significant damage to the coronary arteries.

The technical solution of the present invention is to provide a pulsed electric field ablation device, comprising:

a positioning catheter, the tube body of the positioning catheter is hollow, and includes an arc-shaped end tube body and a lumen;

Pulsed electric field ablation device.

In a preferred embodiment, the ablation device further includes a hollow tube body disposed at the rear end of the arc-shaped distal tube body.

In another preferred embodiment, the outer diameter of the catheter is 3F or 4F or 5F.

In another preferred embodiment, the pulsed electric field ablation device includes a pulsed ablation catheter, a wire, a connector, and a pulsed energy emission device, and the pulsed ablation catheter is connected to the pulsed energy emission device through the wire and the connector.

In another preferred example, the pulse ablation catheter is provided with 2N electrodes at intervals, wherein N is a positive integer, and the polarities of two adjacent electrodes are opposite.

In another preferred embodiment, the width of the electrode is at least 2 mm.

In another preferred example, the distance between the 2N adjacent electrodes is 4mm-5mm.

In another preferred embodiment, the pulsed electric field ablation device further comprises an auxiliary device intravascular ultrasound catheter capable of moving in the lumen.

The present invention also provides a method for using a pulsed electric field ablation device, comprising the following steps: a. providing the ablation device as described above;

b. The positioning catheter of the ablation device is sent along the guide wire into the coronary artery wrapped by the myocardial bridge, and the location of the myocardial bridge is located by coronary angiography;

c. Adjust the arc-shaped end tube body to adjust the arc-shaped end tube body to the position opposite to the myocardial bridge, and then send the pulse ablation catheter of the pulsed electric field ablation device from the head end of the positioning catheter through the lumen of the positioning catheter into the arc Pulse energy is released to the position of the myocardial bridge, the pulse energy is multiple groups of pulse waves, and the voltage amplitude is 200-2000V. During ablation, the compression of the myocardial bridge is observed by coronary angiography, and repeated if necessary. Pulses are delivered until the myocardial bridge squeeze is significantly relieved.

The present invention also provides another method for using a pulsed electric field ablation device, comprising the following steps: a. providing the ablation device as described above;

B, the positioning catheter is sent along the guide wire into the coronary artery wrapped by the myocardial bridge, and the location of the myocardial bridge is preliminarily located by coronary angiography;

c. Then, the intravascular ultrasound catheter is sent from the head end of the catheter through the lumen of the positioning catheter into the myocardial bridge area, and the position and direction of the myocardial bridge are accurately identified according to the "half-moon phenomenon", so that the arc-shaped end tube body is adjusted to match the half-moon shape. The relative position of the anechoic zone, and then withdraw the intravascular ultrasound catheter from the catheter;

d. Finally, the pulse ablation catheter of the pulsed electric field ablation device is sent from the head end of the positioning catheter through the lumen of the positioning catheter to the position of the arc-shaped end tube body, and the pulse energy is released to the half-moon anechoic zone. The pulse energy is multiple groups. The pulse wave group, the voltage amplitude is 200-2000V, the compression of the myocardial bridge is observed by coronary angiography during ablation, and pulses are issued several times if necessary until the myocardial bridge compression phenomenon is significantly relieved.

The beneficial effects of the present invention are as follows: the present invention can realize minimally invasive treatment of myocardial bridge, especially combined with intravascular ultrasound catheter (IVUS) for treatment, and can solve the clinical problem of myocardial bridge accurately, efficiently and with little side effect.

Description of drawings

FIG. 1 is a schematic diagram of the structure of the catheter of the first embodiment.

Fig. 2 is a front view of the catheter of the first embodiment.

Fig. 3 is a cross-sectional view of the catheter of the first embodiment.

FIG. 4 is a schematic structural diagram of the ablation device according to the first embodiment.

5 is a cross-sectional view of the ablation device of the first embodiment.

FIG. 6 is a schematic diagram of the structure of the catheter of the second embodiment.

Fig. 7 is a front view of the catheter of the second embodiment.

Fig. 8 is a cross-sectional view of the catheter of the second embodiment.

FIG. 9 is a schematic view of the positioning catheter and the ablation device in operation in the first embodiment.

FIG. 10 is a schematic view of the positioning catheter and the ablation device in operation in the second embodiment.

Detailed ways

The present invention will be further described below in conjunction with specific embodiments. It should be understood that these examples are only used to illustrate the present invention and not to limit the scope of the present invention. Furthermore, the drawings are schematic diagrams, and thus the device of the present invention is not limited by the size or scale of the schematic diagrams.

It should be noted that, in the claims and description of this patent, relational terms such as head end and end end are only used to relate one entity or operation to another entity or operation distinguish, without necessarily requiring or implying any such actual relationship or order between these entities or operations. Moreover, the term "comprising" or any other variation thereof is intended to cover non-exclusive inclusion, whereby a process, method, article or device comprising a series of elements includes not only those elements, but also other elements not expressly listed, Or also include elements inherent to such a process, method, article or apparatus. Without further limitation, an element qualified by the phrase "comprising a" does not preclude the presence of additional identical elements in a process, method, article, or device that includes the element.

Example 1

As shown in Figures 1-3, the ablation device includes a positioning catheter 1 and a pulsed electric field ablation device 2. The tube body of the positioning catheter 1 is hollow, including an arc-shaped end tube body 11 and a lumen 12. The arc-shaped end tube body 11 is in the The radial direction is half of the complete tube body; the head end and the tail end of the arc-shaped end tube body 11 are respectively provided with radiopaque markers 14 and 15, through which the operator can observe the insertion of the positioning catheter 1 Depth of coronary arteries.

The pulsed electric field ablation device 2 includes a pulsed ablation catheter 21, a lead 22, a connector 23 and a pulsed energy transmitting device (not shown in the figure). The pulsed ablation catheter 21 is connected to the pulsed energy transmitting device through the lead22 and the connector 23, There are four electrodes 24 in the length direction, the polarities of two adjacent electrodes are opposite, the width of each electrode is 2mm, and the distance between adjacent electrodes is 5mm; Each electrode 24 is provided with a radiopaque marker 25, through which the operator can observe the depth of the pulse ablation catheter 21 inserted into the coronary artery and the position of each electrode 24 in the coronary artery; pulse ablation The outer diameter of the catheter 21 is smaller than the inner diameter of the lumen of the positioning catheter 1 so that it can move in the lumen 12 of the positioning catheter 1 .

The ablation device also includes an auxiliary device intravascular ultrasound catheter (IVUS, not shown) that can move within the lumen of the catheter 1 , the outer diameter of the intravascular ultrasound catheter is smaller than the inner diameter of the lumen of the positioning catheter 1 .

Example 2

As shown in Figures 6-8, the ablation device includes a positioning catheter 1, an intravascular ultrasound catheter (not shown in the figure), and a pulsed electric field ablation device 2. The tube body of the positioning catheter 1 is hollow and includes an arc-shaped end tube body 11 , the lumen 12 and the hollow tube body 13 arranged at the rear end of the arc-shaped end tube body 11. The arrangement of the hollow tube body 13 can prevent the rear end of the arc-shaped end tube body 11 from scratching the coronary arteries, and the length of the hollow tube body 13 is 5mm, and the arc-shaped end tube body 11 is half of the complete tube body in the radial direction; the tube bodies connected with the head end and the tail end of the arc-shaped end tube body 11 are respectively provided with radiopaque markers 16, 17. The operator can observe the depth of insertion of the positioning catheter 1 into the coronary arteries through the two markers.

The pulsed electric field ablation device 2 includes a pulsed ablation catheter 21, a lead 22, a connector 23 and a pulsed energy transmitting device (not shown in the figure). The pulsed ablation catheter 21 is connected to the pulsed energy transmitting device through the lead22 and the connector 23, Four electrodes 24 are arranged in the length direction, and the polarities of two adjacent electrodes 24 are opposite, the width of each electrode is 2mm, and the distance between adjacent electrodes is 5mm; The four electrodes 24 are respectively provided with radiopaque markers 25, through which the operator can observe the depth of the pulse ablation catheter 21 inserted into the coronary artery and the position of each electrode 24 in the coronary artery; The outer diameter of the ablation catheter 21 is smaller than the inner diameter of the lumen of the positioning catheter 1 so that it can move within the lumen 12 of the positioning catheter 1 .

The ablation device also includes an auxiliary device intravascular ultrasound catheter (IVUS, not shown) that can move within the lumen of the catheter 1 , the outer diameter of the intravascular ultrasound catheter is smaller than the inner diameter of the lumen of the positioning catheter 1 .

Example 3

This embodiment is a method of using the ablation devices of Embodiments 1 and 2. This embodiment is aimed at pulsed electric field ablation of myocardial bridges with coronary artery diameter <2 mm, and the outer diameter of the positioning catheter 1 is 3F. Include the following steps:

a. Provide any of the ablation devices described in Embodiments 1 and 2;

b. The positioning catheter 1 of the ablation device is sent along the guide wire into the coronary artery wrapped by the myocardial bridge, and the location of the myocardial bridge is located by coronary angiography;

c. Adjust the arc-shaped end tube body 11 to adjust the arc-shaped end tube body 11 to the position opposite to the myocardial bridge, and then pass the pulse ablation catheter 21 of the pulsed electric field ablation device 2 from the head end of the positioning catheter 1 through the positioning catheter 1 The lumen 12 is sent into the position of the arc-shaped end tube body 11 (as shown in Figures 9 and 10), and pulse energy is released to the position of the myocardial bridge. The pulse energy is multiple groups of pulse waves, and the voltage amplitude is 200-2000V. Coronary angiography was used to observe the compression of the myocardial bridge, and if necessary, pulses were issued several times until the compression of the myocardial bridge was significantly relieved.

Example 4

This embodiment is another method of using the ablation devices of Embodiments 1 and 2. This embodiment is aimed at pulsed electric field ablation of myocardial bridges with a coronary artery diameter ≥ 2 mm, and the outer diameter of the positioning catheter 1 is 4F or 5F. Include the following steps:

a. Provide any of the ablation devices described in Embodiments 1 and 2;

B, the catheter 1 is sent along the guide wire into the coronary artery wrapped by the myocardial bridge, and the location of the myocardial bridge is preliminarily located by coronary angiography;

c. Then, the intravascular ultrasound catheter is sent from the head end of the catheter 1 through the lumen 12 of the catheter 1 into the myocardial bridge area, and the position and direction of the myocardial bridge are accurately identified according to the "half-moon phenomenon", so that the curved end tube body 11 is adjusted to The position opposite to the half-moon-shaped anechoic zone (that is, the direction of the half-moon-shaped anechoic zone can be seen), and then withdraw the intravascular ultrasound catheter from the positioning catheter 1;

d. Finally, the pulse ablation catheter 21 of the pulse ablation device 2 is sent from the head end of the positioning catheter 1 through the lumen 12 of the catheter 1 to the position of the arc-shaped end tube body 11 (as shown in Figs. The echo area releases pulse energy, the pulse energy is multiple groups of pulse waves, and the voltage amplitude is 200-2000V. During ablation, coronary angiography is used to observe the compression of the myocardial bridge, and if necessary, the pulse is released multiple times until the myocardial bridge compression phenomenon is obvious. ease.

During IVUS examination, a half-moon-shaped anechoic zone can be observed between the epicardium and the vessel wall throughout the cardiac cycle, which is called the "half-moon phenomenon". The myocardial bridge is O-shaped when it is completely wrapped with MCA, and C-shaped when it is not completely wrapped. IVUS has high sensitivity in diagnosing myocardial bridges, and not only has high repeatability in clinical operations, but also can identify the nature of plaques, which is less affected by the operator's subjectivity. Under the precise guidance of the intravascular ultrasound catheter, the ablation device can precisely locate the myocardial bridge, and the design of the arc-shaped end tube body 11 of the positioning catheter 1 can help the pulse ablation catheter 21 to accurately locate the location of the half-moon anechoic zone, so that the The pulsed ablation catheter 21 releases a suitable pulsed electric field to release the myocardial bridge without significant damage to the coronary arteries.

It should be noted that although the above preferred embodiment defines that the arc-shaped end pipe body 11 is half of the complete pipe body in the radial direction, it does not mean that this is the only embodiment, and it may be 1/1 of the complete pipe body. 4-3/4; in the preferred embodiment, the number of electrodes is limited to 4, and the number of electrodes can be set according to actual needs; the length of the arc-shaped end tube body 11 and the ablation catheter 21 depends on the number of electrodes; The length of the empty tube body 13 can also be determined according to actual needs, and is not necessarily 5 mm.

The embodiments described in the present invention only provide a best mode of implementation. The technical content and technical features of the present invention have been disclosed as above. However, those skilled in the art may still make various modifications based on the contents disclosed in the present invention. Substitutions and modifications that depart from the creative spirit of the present invention. The protection scope of the present invention is not limited to the technical contents disclosed in the embodiments, so all equivalent changes made according to the shape, structure and principle of the present invention are all covered within the protection scope of the present invention.

Claims (10)

1. A pulsed electric field ablation device, comprising:

the catheter comprises a positioning catheter (1), wherein a catheter body of the positioning catheter (1) is hollow and comprises an arc-shaped tail end catheter body (11) and a catheter cavity (12);

a pulsed electric field ablation device (2).

2. The pulsed electric field ablation device according to claim 1, further comprising a hollow tube (13) disposed at a trailing end of the curved end tube (11).

3. Pulsed electric field ablation apparatus according to claim 1 wherein the catheter (1) has an outer diameter of 3F or 4F or 5F.

4. The pulsed electric field ablation apparatus according to claim 1, wherein the pulsed electric field ablation device (2) comprises a pulsed ablation catheter (21), a lead (22), a connector (23) and a pulsed energy emitting device, and the pulsed ablation catheter (21) is connected with the pulsed energy emitting device through the lead (22) and the connector (23).

5. The pulsed electric field ablation device according to claim 4, wherein 2N electrodes are arranged on the pulsed ablation catheter (21) at intervals, wherein N is a positive integer, and the polarities of the two adjacent electrodes are opposite.

6. The pulsed electric field ablation device of claim 5 wherein the width of the electrode is at least 2 mm.

7. The pulsed electric field ablation device of claim 5 wherein the spacing between the 2N adjacent electrodes is between 4mm and 5 mm.

8. The pulsed electric field ablation apparatus of claim 1 further comprising an auxiliary device intravascular ultrasound catheter movable within the lumen (12).

9. A method of using a pulsed electric field ablation device, comprising the steps of:

a. providing the ablation device of any of claims 1-8;

b. the positioning catheter (1) of the ablation equipment is sent into the coronary artery wrapped by the myocardial bridge along a guide wire, and the position of the myocardial bridge is positioned through coronary angiography;

c. adjusting an arc-shaped tail end pipe body (11), so that the arc-shaped tail end pipe body (11) is adjusted to a position opposite to a myocardial bridge, then sending a pulse ablation catheter (21) of a pulse electric field ablation device (2) into the position of the arc-shaped tail end pipe body (11) from the head end of a positioning catheter (1) through a lumen (12) of the positioning catheter (1), releasing pulse energy to the position of the myocardial bridge, wherein the pulse energy is a plurality of groups of pulse wave groups, the voltage amplitude is 200 and 2000V, observing the compression condition of the myocardial bridge through coronary angiography during ablation, and releasing pulses for many times if necessary until the myocardial bridge extrusion phenomenon is obviously relieved.

10. A method of using a pulsed electric field ablation device, comprising the steps of:

a. providing an ablation device according to any of claims 1-8;

b. the positioning catheter (1) is sent into a coronary artery wrapped by a myocardial bridge along a guide wire, and the position of the myocardial bridge is preliminarily positioned through coronary angiography;

c. then, the intravascular ultrasound catheter passes through a lumen (12) of the positioning catheter (1) from the head end of the catheter and is sent into a myocardial bridge area, the position and the direction of the myocardial bridge are accurately identified according to the half-moon phenomenon, the arc-shaped tail end tube body (11) is adjusted to the position corresponding to the half-moon-shaped non-echo area, and then the intravascular ultrasound catheter is withdrawn from the positioning catheter (1);

d. and finally, the pulse ablation catheter (21) of the pulse electric field ablation device (2) is sent to the position of the arc-shaped tail end tube body (11) from the head end of the positioning catheter (1) through the lumen (12) of the positioning catheter (1), pulse energy is released to the half-moon-shaped anechoic region, the pulse energy is a plurality of groups of pulse wave groups, the voltage amplitude is 200-2000V, the compression condition of the myocardial bridge is observed through coronary angiography during ablation, and pulses are issued for multiple times if necessary until the extrusion phenomenon of the myocardial bridge is obviously relieved.

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