CN114903585A

CN114903585A - Pulsed electric field ablation equipment and use method thereof

Info

Publication number: CN114903585A
Application number: CN202110178429.XA
Authority: CN
Inventors: 裴志强; 蔡星星; 沈雳; 李毅刚; 葛均波
Original assignee: Beijing Kangwei Medical Technology Co ltd
Current assignee: Nanjing Xinke Medical Instrument Co ltd
Priority date: 2021-02-09
Filing date: 2021-02-09
Publication date: 2022-08-16

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

Pulsed electric field ablation equipment and use method thereof

Technical Field

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

Background

The part of the coronary artery running inside the myocardial tissue is called as the mural coronary artery (ICA), and the corresponding myocardial tissue covered on the ICA is pressed on the surface of the ICA like a bridge, which is called as the coronary artery myocardial bridge (myocardial bridge). This myocardial bridge systolic compression of the ICA may continue until late diastole, reducing the ICA's blood supply. Autopsy data prove that the incidence rate of myocardial bridges is 40 to 80 percent. Coronary atherosclerosis is easy to be combined at the proximal end of the myocardial bridge, which causes myocardial ischemia, arrhythmia, myocardial depression, left heart dysfunction, syncope and even sudden death. Myocardial bridge diagnostic techniques are diverse, and imaging diagnosis is mainly performed by coronary angiography, intravascular ultrasound (IVUS), CT angiography and other examination means.

At present, the minimally invasive treatment mode in the aspect of no myocardial bridge is mainly adopted for symptomatic myocardial bridge patients by adopting drug treatment and non-drug treatment. Non-drug treatment mainly includes interventional therapy, coronary artery bypass grafting and myobridge releasing operation. Complications such as long-term stent restenosis, coronary perforation, stent fracture and the like can occur in interventional therapy; the main problems with coronary artery bypass grafting are the competition for blood flow between the bypass and the coronary arteries, and the need for extensive surgical trauma; the muscle bridge release operation requires large surgical trauma, and adverse events such as ventricular perforation and operation scar which compresses coronary artery again can be caused.

The pulsed electric field ablation is that high-voltage electric pulses act on phospholipid bilayers of cell membranes in a short time to cause transmembrane potential to be formed, so that unstable potential is generated, irreversible penetrating damage (namely irreversible electroporation) is formed on the cell membranes, and nanoscale pores are generated, so that the permeability of the cell membranes is changed, the homeostasis of the cell internal environment is damaged, and finally cell apoptosis is caused.

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 the myocardium) can be specifically ablated. The ablation threshold of myocardial tissue is lower than that of many other tissues, and adjacent tissues (such as blood vessels, nerves and esophagus) can be prevented from being damaged while myocardial cells are ablated. (3) Compared with the traditional radio frequency ablation mode, the pulsed electric field ablation can cause extensive myocardial damage without depending on the catheter attaching force. (4) Pulsed electric field ablation is extremely fast, often in milliseconds or even less.

Animal experiments using pulsed electric field ablation on coronary arteries showed: under the ablation energy which can cause deep myocardial lesions, no obvious damage is caused to coronary arteries, and no luminal stenosis is seen in short-term (3 weeks) or long-term (3 months) follow-up. The characteristic that the pulsed electric field ablation threshold has tissue specificity is utilized, and the pulsed electric field ablation in the coronary artery and the myocardial bridge is an ideal treatment mode. At present, pulse ablation is applied to atrial fibrillation and tumor treatment in the market, and used instruments cannot be operated in coronary arteries or used in combination with IVUS.

Disclosure of Invention

The invention aims to: aiming at the problems of large operation trauma and postoperative complications in the prior art, the equipment for pulse ablation of the myocardial bridge in the coronary artery is provided, and a proper pulse electric field is released to loosen the myocardial bridge without obvious damage to the coronary artery.

The technical scheme of the invention is as follows: there is provided a pulsed electric field ablation device comprising:

the catheter body of the positioning catheter is hollow and comprises an arc-shaped tail end catheter body and a catheter cavity;

a pulsed electric field ablation device.

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

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

In another preferred example, the pulsed electric field ablation device comprises a pulsed ablation catheter, a lead, a connector and a pulsed energy emitting device, wherein the pulsed ablation catheter is connected with the pulsed energy emitting device through the lead and the connector.

In another preferred example, 2N electrodes are arranged on the pulse ablation catheter at intervals, where 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-5 mm.

In another preferred example, the pulsed electric field ablation apparatus further comprises an auxiliary device intravascular ultrasound catheter movable within the lumen.

The invention also provides a using method of the pulsed electric field ablation device, which comprises the following steps: a. Providing an ablation apparatus as described above;

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

c. adjusting the arc-shaped tail end pipe body to enable the arc-shaped tail end pipe body to be adjusted to a position opposite to the myocardial bridge, then sending a pulse ablation catheter of the pulsed electric field ablation device into the position of the arc-shaped tail end pipe body from the head end of the positioning catheter through a lumen of the positioning catheter, 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 plus 2000V, the compression condition of the myocardial bridge is observed through coronary angiography during ablation, and pulses are issued for many times if necessary until the extrusion phenomenon of the myocardial bridge is obviously relieved.

The invention also provides another using method of the pulsed electric field ablation device, which comprises the following steps: a. Providing an ablation device as described above;

b. the positioning catheter 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 the lumen of the positioning catheter 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 is adjusted to the position corresponding to the half-moon-shaped echo-free area, and then the intravascular ultrasound catheter is withdrawn from the catheter;

d. and finally, the pulse ablation catheter of the pulse electric field ablation device penetrates through the lumen of the positioning catheter from the head end of the positioning catheter to be sent to the position of the arc-shaped tail end tube body, 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 distributed for many times if necessary until the extrusion phenomenon of the myocardial bridge is obviously relieved.

The invention has the beneficial effects that: 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.

Drawings

Fig. 1 is a schematic structural view of a catheter according to embodiment 1.

Fig. 2 is a front view of the catheter of embodiment 1.

Fig. 3 is a cross-sectional view of the catheter of embodiment 1.

Fig. 4 is a schematic structural diagram of the ablation device of the first embodiment 1.

Fig. 5 is a cross-sectional view of the ablation device of embodiment 1.

Fig. 6 is a schematic structural view of a catheter according to embodiment 2.

Fig. 7 is a front view of the catheter of embodiment 2.

Figure 8 is a cross-sectional view of the catheter of embodiment 2.

Fig. 9 is a schematic view of the positioning catheter and ablation device of embodiment 1 in operation.

Fig. 10 is a schematic view of the positioning catheter and ablation device of embodiment 2 in operation.

Detailed Description

The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, the drawings are schematic and the device of the invention is therefore not limited by the dimensions or proportions of the schematic.

It is noted that in the claims and description of the patent, relational terms such as head end and tail end are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, the use of the verb "comprise a" to define an element does not exclude the presence of another, same element in a process, method, article, or apparatus that comprises the element.

Example 1

As shown in fig. 1-3, the ablation apparatus comprises a positioning catheter 1 and a pulsed electric field ablation device 2, wherein the catheter body of the positioning catheter 1 is hollow and comprises an arc-shaped tail end catheter body 11 and a lumen 12, and the arc-shaped tail end catheter body 11 is half of the complete catheter body in the radial direction; the tip and tail ends of the arcuate distal body 11 are provided with

radiopaque markers

14, 15, respectively, which allow the operator to view the depth to which the positioning catheter 1 is inserted into the coronary artery.

The pulsed electric field ablation device 2 comprises a pulsed ablation catheter 21, a conducting wire 22, a connector 23 and a pulsed energy emitting device (not shown in the figure), wherein the pulsed ablation catheter 21 is connected with the pulsed energy emitting device through the conducting wire 22 and the connector 23, 4 electrodes 24 are arranged along the length direction of the pulsed ablation catheter, the polarities of every two adjacent electrodes are opposite, the width of each electrode is 2mm, and the distance between every two adjacent electrodes is 5 mm; the head end and the tail end of the pulse ablation catheter 21 and the 4 electrodes 24 are respectively provided with a radio-opaque marker 25, and the marker 25 can enable an operator to observe the depth of the insertion of the pulse ablation catheter 21 into the coronary artery and the position of each electrode 24 in the coronary artery; the external diameter of the pulse ablation catheter 21 is smaller than the inner diameter of the lumen of the positioning catheter 1, so that the pulse ablation catheter 21 can move in the lumen 12 of the positioning catheter 1, and when the pulse ablation catheter 21 is used, the pulse ablation catheter 21 is matched with the positioning catheter 1.

The ablation apparatus further comprises an auxiliary device intravascular ultrasound catheter (IVUS, not shown) movable within the lumen of the catheter 1, the intravascular ultrasound catheter having an outer diameter smaller than the inner diameter of the lumen of the positioning catheter 1.

Example 2

As shown in fig. 6-8, the ablation apparatus includes a positioning catheter 1, an intravascular ultrasound catheter (not shown in the figure), and a pulsed electric field ablation device 2, wherein the catheter body of the positioning catheter 1 is hollow, and includes an arc-shaped end catheter body 11, a lumen 12, and a hollow catheter body 13 disposed at the tail end of the arc-shaped end catheter body 11, the hollow catheter body 13 is disposed to prevent the tail end of the arc-shaped end catheter body 11 from scratching coronary arteries, the length of the hollow catheter body 13 is 5mm, and the arc-shaped end catheter body 11 is half of the complete catheter body in the radial direction;

radiopaque markers

16, 17 are provided on the tubes connected to the head and tail ends of the arcuate distal tube 11, respectively, to allow the operator to view the depth of insertion of the positioning catheter 1 into the coronary artery.

The pulsed electric field ablation device 2 comprises a pulsed ablation catheter 21, a lead wire 22, a connector 23 and a pulsed energy emitting device (not shown in the figure), wherein the pulsed ablation catheter 21 is connected with the pulsed energy emitting device through the lead wire 22 and the connector 23, 4 electrodes 24 are arranged along the length direction of the pulsed ablation catheter, the polarities of two adjacent electrodes 24 are opposite, the width of each electrode is 2mm, and the distance between every two adjacent electrodes is 5 mm; the head end and the tail end of the pulse ablation catheter 21 and the 4 electrodes 24 are respectively provided with a radio-opaque marker 25, and the marker 25 can enable an operator to observe the depth of the insertion of the pulse ablation catheter 21 into the coronary artery and the position of each electrode 24 in the coronary artery; the outside diameter of the pulse ablation catheter 21 is smaller than the inside diameter of the lumen of the positioning catheter 1 so that it can move within the lumen 12 of the positioning catheter 1.

Example 3

This example is a method of using the ablation apparatus of examples 1 and 2, which is directed to myocardial bridge pulsed electric field ablation with coronary diameter < 2mm, and the outer diameter of the positioning catheter 1 is 3F. The method comprises the following steps:

a. providing an ablation apparatus as described in any of

embodiments

1 and 2;

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

c. adjusting the arc-shaped end pipe body 11 to enable the arc-shaped end pipe body 11 to be adjusted to a position opposite to the myocardial bridge, then sending a pulse ablation catheter 21 of the pulse electric field ablation device 2 into the position (shown in figures 9 and 10) of the arc-shaped end pipe body 11 from the head end of the positioning catheter 1 through the 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 200-2000V, the compression condition of the myocardial bridge is observed through coronary angiography during ablation, and pulses are released for a plurality of times when necessary until the extrusion phenomenon of the myocardial bridge is obviously relieved.

Example 4

The embodiment is another use method of the ablation devices of the

embodiments

1 and 2, and the embodiment is directed to myocardial bridge pulsed electric field ablation with the coronary diameter being more than or equal to 2mm, and the outer diameter of the positioning catheter 1 is 4F or 5F. The method comprises the following steps:

a. providing an ablation apparatus as described in any of

embodiments

1 and 2;

b. the 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 the lumen 12 of the catheter 1 from the head end of the catheter 1 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 anechoic zone (namely the direction of the half-moon-shaped anechoic zone can be seen), and then the intravascular ultrasound catheter is withdrawn from the positioning catheter 1;

d. finally, the pulse ablation catheter 21 of the pulse ablation device 2 is sent into 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 catheter 1 (as shown in fig. 9 and 10), 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 distributed for many times as necessary until the extrusion phenomenon of the myocardial bridge is obviously relieved.

During IVUS examination, a half-moon-shaped anechoic region is observed between the epicardium and the wall of the blood vessel in the whole cardiac cycle, which is called as 'half-moon phenomenon', and the myocardial bridge is O-shaped when completely wrapping MCA and C-shaped when not completely wrapping MCA. The IVUS has higher sensitivity in diagnosing the myocardial bridge, has high repeatability in clinical operation, can identify the plaque property and is slightly influenced by the subjectivity of an operator. Under the accurate guide of this ablation equipment at intravascular ultrasound catheter, accomplish the accurate positioning of cardiac muscle bridge, the design of 1 arc-shaped end body 11 of location pipe can help pulsar ablation pipe 21 accurate positioning half-moon shape no echo district position to make pulsar ablation pipe 21 release suitable pulse electric field and release the cardiac muscle bridge, and do not have obvious damage to coronary artery.

It should be noted that although the preferred embodiment above defines the arcuate end tube 11 as being half of a complete tube in the radial direction, this is not meant to be the only embodiment and may be 1/4-3/4; the number of the electrodes is limited to 4 in the preferred embodiment, and the number of the electrodes can be set according to requirements in practical use; the lengths of the arc-shaped end pipe body 11 and the ablation catheter 21 are determined according to the number of the electrodes; the length of the hollow tube 13 may be determined according to actual needs, and is not necessarily 5 mm.

While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. The scope of the present invention is not limited to the embodiments disclosed, and all equivalent changes in the form, construction and principle of the present invention are intended to be covered by the present invention.

Claims

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.