A pulsed electric field ablation device and its usage method

Abstract

The present invention belongs to the field of medical devices and discloses a pulsed electric field ablation device and its use method, comprising: an ablation catheter having a hollow body with two open ends, a curved end tube and a lumen, and 2N electrodes spaced along the length of the curved end tube, where N is a positive integer and adjacent electrodes have opposite polarities. The present invention can achieve minimally invasive treatment of myocardial bridges, particularly for myocardial bridges with a coronary artery diameter of 2mm or greater. The device can be combined with an intravascular ultrasound catheter (IVUS) for treatment, providing a precise, efficient, and minimally side-effected solution to the clinical problem of myocardial bridges.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a pulsed electric field ablation device and a method of using the same. Background Art

[0002] The portion of the coronary artery that courses within the myocardium is called the intramural coronary artery (ICA). Overlying myocardial tissue compresses the ICA in a bridge-like pattern, a condition known as a coronary myocardial bridge (MB). This MB compresses the ICA during systole and can persist into late diastole, reducing blood flow to the ICA. Autopsy data confirm the incidence of MB in 40% to 80% of cases. The proximal portion of the MB is prone to coronary atherosclerosis, leading to myocardial ischemia and potentially causing arrhythmias, myocardial depression, left ventricular dysfunction, syncope, and even sudden death. A variety of diagnostic techniques are available for MB, with imaging primarily used for diagnosis, including coronary angiography, intravascular ultrasound (IVUS), and CT angiography.

[0003] Currently, there are no minimally invasive treatments for myocardial bridging. For patients with symptomatic myocardial bridging, drug and non-drug treatments are the primary options. Non-drug treatments primarily include interventional therapy, coronary artery bypass grafting (CABG), and myocardial bridge release. Interventional therapy can lead to long-term complications such as stent restenosis, coronary artery perforation, and stent fracture. The main challenge with CABG is the competition for blood flow between the bypass and the coronary arteries, and the surgical procedure is highly invasive. Myocardial bridge release requires a highly invasive surgical procedure and can be associated with adverse events such as ventricular perforation and re-compression of the coronary arteries by surgical scars.

[0004] Pulsed electric field ablation refers to the application of high-voltage electric 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 electric potential, causing irreversible penetrating damage to the cell membrane (i.e., irreversible electroporation), generating nanoscale pores, thereby leading to changes in cell membrane permeability, destroying the homeostasis of the intracellular environment, and ultimately causing cell apoptosis.

[0005] Pulsed electric field ablation has the following characteristics: (1) Pulsed electric field ablation can preserve the extracellular matrix. (2) The ablation threshold is tissue-specific, allowing specific ablation of certain tissues (such as the myocardium). The ablation threshold of myocardial tissue is lower than that of many other tissues, and while ablating myocardial cells, it can avoid damage to adjacent tissues (such as blood vessels, nerves, and esophagus). (3) Compared with traditional radiofrequency ablation, pulsed electric field ablation does not rely on catheter contact force to cause extensive myocardial damage. (4) Pulsed electric field ablation is extremely fast, often measured in milliseconds or even less.

[0006] Animal studies using pulsed field ablation (PFA) on coronary arteries have shown that even at ablation energies capable of causing deep myocardial lesions, no significant coronary artery damage was observed, and no luminal stenosis was observed during short-term (3 weeks) or long-term (3 months) follow-up. Leveraging the tissue-specific nature of PFA thresholds, intracoronary PFA for myocardial bridges is an ideal treatment option. Currently, PFA is used in the treatment of atrial fibrillation and tumors, but the devices used cannot be performed intracoronarily and cannot be combined with IVUS. Summary of the Invention

[0007] The purpose of the present invention is to provide a device for pulse ablation of myocardial bridges in coronary arteries to address the problems of large surgical trauma and postoperative complications in the existing technology, which releases a suitable pulse electric field to loosen the myocardial bridge without obvious damage to the coronary arteries.

[0008] The technical solution of the present invention is to provide a pulsed electric field ablation device, comprising: an ablation catheter, the tube body of the ablation catheter is hollow and includes an arc-shaped end tube body and a lumen, and 2N electrodes are spaced apart along the length direction of the arc-shaped end tube body, where N is a positive integer, and the polarities of two adjacent electrodes are opposite.

[0009] In a preferred embodiment, the ablation device further comprises a hollow tube body arranged at the tail end of the arc-shaped terminal tube body.

[0010] In another preferred embodiment, the outer diameter of the ablation catheter is 3F, 4F or 5F.

[0011] In another preferred embodiment, the width of the electrode is at least 2 mm.

[0012] In another preferred embodiment, the spacing between the 2N adjacent electrodes is 4 mm to 5 mm.

[0013] In another preferred embodiment, the ablation device further includes a side tube provided on one side of the ablation catheter.

[0014] In another preferred embodiment, the ablation device further includes a wire passing through the lumen of the ablation catheter and connected to the electrode, and a connector connected to the wire.

[0015] In another preferred embodiment, the ablation device further comprises an auxiliary device, an intravascular ultrasound catheter, which is movable within the lumen.

[0016] The present invention also provides a method for using a pulsed electric field ablation device, comprising the following steps:

[0017] a. Providing the ablation device as described above;

[0018] b. advancing the ablation catheter of the ablation device along the guide wire into the coronary artery surrounded by the myocardial bridge, and preliminarily locating the location of the myocardial bridge by coronary angiography;

[0019] c. Then, the intravascular ultrasound catheter is passed along the guidewire from the head end of the ablation catheter through the lumen of the pulse ablation catheter into the myocardial bridge area. The position and direction of the myocardial bridge are accurately identified based on the "half-moon phenomenon". The arc-shaped end tube of the ablation catheter is adjusted to block the "half-moon" ultrasound signal as the release direction of the pulse energy. The energy is multiple groups of pulse waves with a voltage amplitude of 200-2000V. During ablation, the compression of the myocardial bridge is observed through coronary angiography. If necessary, pulses are released multiple times until the myocardial bridge compression phenomenon is significantly relieved.

[0020] The present invention also provides another method for using a pulsed electric field ablation device, comprising the following steps:

[0021] a. Providing the ablation device as described above;

[0022] b. advancing the ablation catheter of the ablation device along the guide wire into the coronary artery surrounded by the myocardial bridge, and locating the location of the myocardial bridge by coronary angiography;

[0023] c. Adjust the curved end of the ablation catheter to block the location of the myocardial bridge as the direction of pulse energy release until the myocardial bridge compression phenomenon is significantly relieved. The energy is multiple groups of pulse waves with a voltage amplitude of 200-2000V. During ablation, observe the compression of the myocardial bridge through coronary angiography. If necessary, release pulses multiple times until the myocardial bridge compression phenomenon is significantly relieved.

[0024] The beneficial effects of the present invention are: the present invention can achieve minimally invasive treatment of myocardial bridges, especially for myocardial bridges with a coronary artery diameter ≥ 2 mm, and can be combined with an intravascular ultrasound catheter (IVUS) for treatment, which can solve the clinical problem of myocardial bridges accurately, efficiently and with few side effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 Schematic diagram of the structure of the ablation device in the first embodiment.

[0026] Figure 2 This is a front view of the ablation device according to the first embodiment.

[0027] Figure 3 This is a cross-sectional view of the ablation device according to the first embodiment.

[0028] Figure 4 Schematic diagram of the structure of the ablation device of the second embodiment.

[0029] Figure 5 This is a front view of the ablation device according to the second embodiment.

[0030] Figure 6 This is a cross-sectional view of the ablation device according to the second embodiment.

[0031] Figure 7 Schematic diagram of the structure of the ablation device in the third embodiment.

[0032] Figure 8 This is a front view of the ablation device according to the third embodiment.

[0033] Figure 9 This is a cross-sectional view of the ablation device according to the third embodiment.

[0034] Figure 10 Schematic diagram of the structure of the ablation device in the fourth embodiment.

[0035] Figure 11 This is a front view of the ablation device according to the fourth embodiment.

[0036] Figure 12 This is a cross-sectional view of the ablation device according to the fourth embodiment. DETAILED DESCRIPTION

[0037] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are intended to illustrate the present invention only and are not intended to limit the scope of the present invention. In addition, the accompanying drawings are schematic diagrams, and therefore the device of the present invention is not limited by the size or proportions of the schematic diagrams.

[0038] It should be noted that, in the claims and specification of this patent, in the claims and specification of this patent, in the claims and specification of this patent, relational terms such as head end and tail end are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the term "comprises" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or apparatus comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or apparatus. In the absence of further restrictions, an element defined by the phrase "comprising a" does not exclude the presence of other identical elements in the process, method, article or apparatus comprising the element.

[0039] Example 1

[0040] like Figure 1-3As shown, the ablation device includes an ablation catheter 1, a side tube 2, a guide wire 3, and a connector 4. The body of the ablation catheter 1 is hollow, including an arc-shaped end tube 11 and a lumen 12. The arc-shaped end tube 11 is half of the complete tube in the radial direction. The length of the arc-shaped end tube is 25 mm. Four electrodes 13 are spaced apart along the length of the arc-shaped end tube, and the polarities of two adjacent electrodes are opposite. The width of each electrode is 2 mm, and the spacing between adjacent electrodes is 5 mm. The head end and the tail end of the arc-shaped end tube 11 are Radiopaque markers 14 and 15 are respectively provided, and the operator can observe the depth of the ablation catheter 1 inserted into the coronary artery through the two markers; the side tube 2 is arranged on one side of the ablation catheter 1, and the side tube 2 is connected to the catheter 1; the wire 3 passes through the lumens of the catheters 1 and 2, and is arranged along the wall of the catheter 1, one end is connected to the electrode 13, and the other end is connected to the head end of the connector 4, and the tail end of the connector 4 is connected to the pulse energy source (not shown in the figure). The connector 4 connects the electrode 13 to the pulse energy source through the wire 3 for energy transmission.

[0041] The ablation device further includes an auxiliary device, an intravascular ultrasound catheter (IVUS, not shown in the figure), which is movable in the lumen of the catheter 1 . The outer diameter of the IVUS catheter is smaller than the inner diameter 12 of the lumen of the ablation catheter 1 .

[0042] Example 2

[0043] like Figure 4-6 As shown, this embodiment is similar to embodiment 1, except that no side tube 2 is provided on one side of the ablation catheter 1 in this embodiment, and the wire 3 passes directly through the lumen of the catheter 1 from the head end of the ablation catheter, one end is connected to the electrode 13, and the other end is connected to the head end of the connector 4, and the tail end of the connector 4 is connected to the pulse energy source (not shown in the figure), and the connector 4 connects the electrode 13 to the pulse energy source through the wire 3 for energy transmission.

[0044] Example 3

[0045] like Figure 7-9As shown, the ablation device includes an ablation catheter 1, a side tube 2, a wire 3, and a connector 4. The body of the ablation catheter 1 is hollow, including an arc-shaped end tube body 11, a lumen 12, and a hollow tube body 16 arranged at the tail end of the arc-shaped end tube body 11. The setting of the hollow tube body 16 can prevent the tail end of the arc-shaped end tube body 11 from scratching the coronary artery. The length of the hollow tube body 16 is 5 mm. The arc-shaped end tube body 11 is half of the complete tube body in the radial direction. The length of the arc-shaped end tube body 11 is 25 mm. Four electrodes 13 are arranged at intervals along the length direction of the arc-shaped end tube body 11, and the polarities of two adjacent electrodes 13 are opposite. The width of each electrode is 2 mm, and the spacing between adjacent electrodes is 5 mm. A marker is provided on each electrode 13, and the marker allows the operator to observe the specific position of each electrode 13 in the coronary artery; radiopaque markers 14, 15, 16 are provided on the tube bodies connected to the head end and the tail end of the arc-shaped end tube body 11, respectively. 18. The two markers allow the operator to observe the depth of the ablation catheter 1 inserted into the coronary artery; the side tube 2 is set on one side of the ablation catheter 1, and the side tube 2 is connected to the catheter 1; the wire 3 passes through the lumens of the catheters 1 and 2, is set along the wall of the catheter 1, one end is connected to the electrode 13, and the other end is connected to the head end of the connector 4, and the tail end of the connector 4 is connected to the pulse energy source (not shown in the figure). The connector 4 connects the electrode 13 to the pulse energy source through the wire 3 for energy transmission.

[0046] The ablation device further includes an auxiliary device, an intravascular ultrasound catheter (IVUS, not shown in the figure), which is movable in the lumen of the catheter 1 . The outer diameter of the IVUS catheter is smaller than the inner diameter 12 of the lumen of the ablation catheter 1 .

[0047] Example 4

[0048] like Figure 10-12 As shown, this embodiment is similar to embodiment 3, except that no side tube 2 is provided on one side of the ablation catheter 1 in this embodiment, and the wire 3 passes directly through the lumen of the catheter 1 from the head end of the ablation catheter, one end is connected to the electrode 13, and the other end is connected to the head end of the connector 4, and the tail end of the connector 4 is connected to the pulse energy source (not shown in the figure), and the connector 4 connects the electrode 13 to the pulse energy source through the wire 3 for energy transmission.

[0049] Example 5

[0050] This embodiment is a method for using the ablation device of embodiments 1, 2, 3, and 4. This embodiment is targeted at myocardial bridge pulsed electric field ablation with a coronary artery diameter ≥ 2 mm. The outer diameter of the ablation catheter 1 is 4 French or 5 French. The following steps are included:

[0051] a. Providing any one of the ablation devices described in Examples 1, 2, 3, and 4;

[0052] b. Inserting the ablation catheter 1 of the ablation device along the guide wire into the coronary artery surrounded by the myocardial bridge, and preliminarily locating the location of the myocardial bridge by coronary angiography;

[0053] c. Then, the intravascular ultrasound catheter is passed along the guide wire from the head end of the ablation catheter 1 through the lumen 12 of the pulse ablation catheter 1 into the myocardial bridge area. The position and direction of the myocardial bridge are accurately identified based on the "half-moon phenomenon". The arc-shaped end tube 11 of the ablation catheter 1 is adjusted to block the "half-moon" ultrasound signal as the release direction of the pulse energy, that is, the myocardial bridge on the epicardial surface. The pulse energy is multiple groups of pulse wave groups with a voltage amplitude of 200-2000V. During ablation, the compression of the myocardial bridge is observed through coronary angiography. If necessary, pulses are released multiple times until the myocardial bridge compression phenomenon is significantly relieved.

[0054] During IVUS examination, a semilunar anechoic area, known as the "half-moon phenomenon," can be observed between the epicardium and the vessel wall throughout the cardiac cycle. A myocardial bridge appears O-shaped when it completely encloses the MCA, and C-shaped when it partially encloses. IVUS has a high sensitivity for diagnosing myocardial bridges, resulting in high reproducibility during clinical practice and the ability to identify plaque properties with minimal operator subjectivity. This ablation device, guided by the precise intravascular ultrasound catheter, can precisely locate the myocardial bridge. The curved distal end tube 11 of the ablation catheter 1 is designed to obscure the semilunar anechoic area, thereby releasing an appropriate pulsed electric field to release the bridge without significant damage to the coronary arteries.

[0055] Example 6

[0056] This embodiment is another method for using the ablation device of embodiments 1, 2, 3, and 4. This embodiment is aimed at pulsed electric field ablation of the left anterior descending myocardial bridge with a coronary artery diameter less than 2 mm. The outer diameter of the ablation catheter 1 is 3 French. The following steps are included:

[0057] a. Providing any one of the ablation devices described in Examples 1, 2, 3, and 4;

[0058] b. Inserting the ablation catheter 1 of the ablation device along the guide wire into the coronary artery surrounded by the myocardial bridge, and locating the location of the myocardial bridge by coronary angiography;

[0059] c. Adjust the curved end of the ablation catheter to release pulse energy in the direction opposite to the septal branch. The pulse energy is multiple pulse wave groups with a voltage amplitude of 200-2000V. During ablation, observe the compression of the myocardial bridge through coronary angiography. If necessary, deliver pulses multiple times until the myocardial bridge compression phenomenon is significantly relieved.

[0060] It should be noted that although the above preferred embodiment defines the arc-shaped end tube body 11 as half of the complete tube body in the radial direction, this does not mean that this is the only implementation scheme, and it can be 1 / 4-3 / 4 of the complete tube body; the preferred embodiment defines the number of electrodes as 4, and the number of electrodes can be set as needed in actual use; the length of the arc-shaped end tube body 11 depends on the number of electrodes; the length of the hollow tube body 16 can also be determined according to actual needs and is not necessarily 5 mm.

[0061] The embodiments described herein provide only a preferred embodiment. The technical content and features of the present invention have been disclosed above. However, those skilled in the art may make various substitutions and modifications based on the disclosure without departing from the spirit of the present invention. The scope of protection of the present invention is not limited to the technical content disclosed in the embodiments. Therefore, any equivalent changes based on the shape, structure, and principle of the present invention are included within the scope of protection of the present invention.

Claims

1. A pulsed electric field ablation device, characterized in that: include: The ablation catheter (1) has a hollow body, comprising an arc-shaped end body (11) and a lumen. (12), the arc-shaped end tube body (11) is half of the complete tube body in the radial direction, and 2N electrodes (13) are arranged at intervals along the length direction of the arc-shaped end tube body, where N is a positive integer, and the polarities of two adjacent electrodes (13) are opposite. The design of the arc-shaped end tube body (11) of the ablation catheter (1) can block the semilunar echo-free area, thereby releasing a suitable pulsed electric field to loosen the myocardial bridge without obvious damage to the coronary artery.

2. The pulsed electric field ablation device according to claim 1, wherein: It also includes a hollow tube body (16) arranged at the tail end of the arc-shaped terminal tube body (11).

3. The pulsed electric field ablation device according to claim 1, wherein: The outer diameter of the ablation catheter (1) is 3F, 4F or 5F.

4. The pulsed electric field ablation device according to claim 1, wherein: The width of the electrode (13) is at least 2mm.

5. The pulsed electric field ablation device according to claim 1, wherein: The spacing between the 2N electrodes (13) is 4 mm to 5 mm.

6. The pulsed electric field ablation device according to claim 1, wherein: It also includes a side tube (2) arranged on one side of the ablation catheter (1).

7. The pulsed electric field ablation device according to claim 1, wherein: It also includes a wire (3) passing through the lumen (12) of the ablation catheter (1) and connected to the electrode (13), and a connector (4) connected to the wire (3).

8. The pulsed electric field ablation device according to claim 1, wherein: Also included is an auxiliary device, an intravascular ultrasound catheter, which is movable within the lumen (12).

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