Pulse ablation catheter and system therefor

Abstract

The application discloses a kind of pulse ablation catheter and its system, including sequentially connected handle, main body tube and electrode assembly, electrode assembly includes multiple first cavities, multiple first cavities are evenly distributed in middle scattering;Second cavity, located outside annular;Further include support, be located in first cavity and the inside of second cavity, for supporting first cavity and second cavity;Multiple first cavities are relative to the arc shape of second cavity upward or downward;First cavity is spaced apart and provided with multiple first ring electrodes, and multiple second ring electrodes are spaced apart and provided on second cavity.The pulse ablation system includes pulse device, electrocardiogram detection device, pulse ablation catheter, and further includes high-pressure resistant tail wire connected with pulse device and pulse ablation catheter.The pulse ablation catheter and its system, electrode assembly can be transformed between dome shape and petal shape, reasonable electrode design and effective adhesion can greatly save operation time and improve pulse ablation effect.

Description

Technical Field

[0001] This invention relates to a medical device, and more particularly to a pulse ablation catheter and system thereof. Background Technology

[0002] Catheter ablation is a technique that involves ablation of the pulmonary veins and left atrium through percutaneous puncture in the endocardium. Compared with drug therapy, its advantage is that it can cure atrial fibrillation and does not require lifelong antiarrhythmic drugs.

[0003] Currently, commonly used ablation techniques can be divided into traditional radiofrequency ablation, cryoablation, and the emerging pulsed ablation. Radiofrequency ablation is usually performed point-to-point, using heating to cause necrosis of target cells in the tissue, thereby isolating the tissue's electrical signals. It is suitable for arrhythmias such as atrial fibrillation and atrial flutter originating in or originating from the pulmonary veins. Its limitations include the potential for radiofrequency energy to affect non-target tissues when applied to the target tissue. For example, applying radiofrequency energy to the atrial wall can cause damage to the esophagus or phrenic nerve near the heart. Furthermore, radiofrequency ablation has a long treatment time, further increasing the possibility of damage to non-target tissues or the risk of tissue crusting, which can further increase the likelihood of embolism. Cryoablation utilizes the endothermic vaporization of liquefied refrigerants to significantly lower the surrounding temperature. Currently, cryoballoon ablation, due to the good adhesion between the balloon and the pulmonary vein opening, can form a continuous and complete ring-shaped ablation focus. One or more ablation sessions can isolate tissue signal transmission, shortening the treatment time. However, cryoballoon ablation has a high incidence of damage to the phrenic nerve and carries a certain risk of esophageal injury and pulmonary vein stenosis.

[0004] Pulsed electric field ablation, as an emerging ablation therapy, utilizes a novel technique to generate microsecond-level pulsed electric fields during the ablation process, creating nanosecond-level micropores in the cell membrane to achieve "electroporation." Compared to smooth muscle and nerve cells, cardiomyocytes have the lowest threshold for pulsed electric fields, making them the first to die during ablation. Unlike traditional thermal ablation methods, pulsed electric fields can selectively ablate cardiac tissue while preserving blood vessels, nerves, and surrounding tissues. Moreover, the irreversible electroporation ablation of myocardial tissue using pulsed electric fields does not require heat conduction, making the ablation process highly efficient and rapid, significantly shortening the ablation time. Because variations in the size and geometry of the human heart can affect the contact between the electrode at the catheter tip and the myocardial tissue, leading to difficulties in rapid and accurate mapping or treatment, there is an urgent need to develop a pulsed ablation catheter that can better conform to human tissue. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the defects in the prior art and provide a pulse ablation catheter and pulse ablation system that can better fit human tissue.

[0006] This invention solves the above-mentioned technical problems through the following technical solution: a pulse ablation catheter, comprising a handle, a main tube, and an electrode assembly connected in sequence, characterized in that the electrode assembly comprises,

[0007] Multiple first cavities are located in the middle and are evenly distributed in a radiating pattern;

[0008] The second cavity is located on the outer side and is ring-shaped;

[0009] It also includes a support member disposed inside the first cavity and the second cavity to support the first cavity and the second cavity;

[0010] The first end of the plurality of first cavities is located in the middle of the electrode assembly, and the second end located on the outside is connected to the second cavity. The plurality of first cavities are arc-shaped relative to the second cavity, either upward or downward.

[0011] The first cavity is provided with a plurality of first annular electrodes spaced apart, and the second cavity is provided with a plurality of second annular electrodes spaced apart.

[0012] Preferably, the second cavity includes multiple arc-shaped segments, which connect the second ends of two adjacent first cavities.

[0013] Preferably, the first end of the first cavity is connected to a fixing member.

[0014] Preferably, the support member is a petal-shaped linear component, including side portions on both sides and a middle portion in the middle. The side portions are arc-shaped linear structures, with the first ends of the two side portions separated from each other, and the middle portion connecting the second ends of the two side portions respectively.

[0015] Preferably, the number of the support members is the same as the number of the first cavities, and the multiple support members are arranged in a ring side by side. The two side parts of adjacent support members jointly support the same first cavity, and the middle part of the support member is used to support the arc segment.

[0016] Preferably, the wire diameter of the side portion of the support member is smaller than the wire diameter of the middle portion, and the side portion and the middle portion are integrally formed.

[0017] Preferably, the outer diameter of the first cavity is larger than the outer diameter of the second cavity, so that the end of the arc-shaped segment can be inserted into the first cavity.

[0018] Preferably, the discharge mode of the first ring electrode and the second ring electrode is a bipolar discharge mode or a unipolar discharge mode.

[0019] Preferably, the number of the first cavities is 3-8, the number of the first annular electrodes on the first cavities is 1-5, and the number of the second annular electrodes on the second cavities is 10-20.

[0020] Preferably, the electrode assembly is dome-shaped, with a radial dimension D of 15mm-35mm and a height H of 5mm-15mm.

[0021] Preferably, the fixing member is a cylindrical component with an inner tube hole that penetrates its thickness at the center and communicates with the inner tube of the main tube. Multiple through-holes are evenly distributed on the outer side of the inner tube hole, and the first end of the first cavity is inserted into the through-hole.

[0022] Preferably, one end of the main tube is connected to the handle, and the other end is provided with a flexible bendable section. The flexible bendable section and the electrode assembly are in a rigid section, and the first end of the first cavity is inserted into the rigid section.

[0023] Preferably, the main tube is a hollow tube with an inner tube extending in the same direction on its inner side, and a wire and a pull wire are provided in the gap between the inner tube and the main tube.

[0024] Preferably, the handle is provided with a Luer interface, which is connected to the inner tube of the main tube for guiding the guide wire or injecting saline solution; the handle is provided with a high-frequency high-voltage socket at one end relative to the main tube.

[0025] In another aspect, the present invention provides a pulse ablation system, characterized in that it comprises,

[0026] Pulse equipment provides pulse energy for pulse ablation;

[0027] An electrocardiogram (ECG) testing device, connected to a pulse device, is used to detect the patient's R wave and trigger the pulse device to release pulse energy;

[0028] The pulse ablation catheter, wherein the pulse ablation catheter is any one of the above-mentioned types.

[0029] It also includes a high-voltage resistant tail wire that connects the pulse device and the pulse ablation catheter to transmit pulse energy.

[0030] Preferably, the pulse energy provided by the pulse device is a high-frequency, high-voltage biphasic electrical pulse with a pulse width of 0.1µs to 50µs and a voltage of 5V to 6000V. The electrocardiogram detection device triggers the pulse device to release the pulse energy 50ms to 200ms after detecting the R wave.

[0031] The positive and progressive effects of this invention are as follows: The distal electrode assembly of the cardiac pulse ablation catheter and system of this invention can be changed between a dome shape and a petal shape. Electrodes are evenly distributed on the first and second cavities to deliver pulse energy and map electrocardiogram signals. The dome-shaped electrode assembly can form a structure similar to the physiological structure of the pulmonary vein orifice during surgery. The ring electrode mounted on the first and second cavities can be better attached to the pulmonary vein orifice. When it is changed to a petal shape, it can be attached to the posterior wall of the left atrium. The reasonable electrode design and effective attachment can greatly save surgical time and improve the pulse ablation effect. Attached Figure Description

[0032] Figure 1 A schematic diagram of the pulse ablation system provided in an embodiment of the present invention;

[0033] Figure 2 A three-dimensional schematic diagram of the electrode assembly in the pulse ablation catheter provided in an embodiment of the present invention;

[0034] Figure 3 A side view of the electrode assembly in the pulsed ablation catheter provided in an embodiment of the present invention;

[0035] Figure 4 A top view of the electrode assembly in the pulsed ablation catheter provided in an embodiment of the present invention;

[0036] Figure 5a A side view of the support member in the electrode assembly of the pulse ablation catheter provided in an embodiment of the present invention;

[0037] Figure 5b A front view of the support member in the electrode assembly of the pulse ablation catheter provided in an embodiment of the present invention;

[0038] Figure 5c This is a schematic diagram of the combined support components in the electrode assembly of the pulse ablation catheter provided in an embodiment of the present invention.

[0039] Figure 6a A side view of another form of the support member in the electrode assembly of the pulse ablation catheter provided in an embodiment of the present invention;

[0040] Figure 6b A front view of another form of the support member in the electrode assembly of the pulse ablation catheter provided in an embodiment of the present invention;

[0041] Figure 6c This is a schematic diagram of another form of support component combined in the electrode assembly of the pulse ablation catheter provided in an embodiment of the present invention.

[0042] Figure 7a One connection method for the electrode assembly in the pulse ablation catheter provided in the embodiments of the present invention;

[0043] Figure 7b This is another connection method for the electrode assembly in the pulse ablation catheter provided in this embodiment of the invention;

[0044] Figure 8 This is a schematic diagram of the connection between the electrode assembly and the main tube of the pulse ablation catheter provided in an embodiment of the present invention;

[0045] Figure 9 A schematic diagram of the connection between the electrode assembly and the fixation member of the pulse ablation catheter provided in this embodiment of the invention;

[0046] Figure 10 A schematic diagram of the fixation component of the pulse ablation catheter provided in an embodiment of the present invention;

[0047] Figure 11 A schematic cross-sectional view of the main tube of the pulse ablation catheter provided in an embodiment of the present invention;

[0048] Figure 12a , 12b A schematic diagram of selective electrode discharge during bipolar discharge of the annular electrode on the electrode assembly in the pulse ablation catheter provided in an embodiment of the invention;

[0049] Figure 13a , Figure 13b The diagram shown is a schematic of the pulse ablation catheter 500 being delivered into the left atrium of the heart through a sheath.

[0050] Figure 14a This is a schematic diagram showing the contact between the electrode assembly of the pulse ablation catheter and the pulmonary vein.

[0051] Figure 14b This is a schematic diagram showing the contact between the electrode assembly of the pulse ablation catheter and the posterior wall of the left atrium.

[0052] Figures 15a-15f This is a schematic diagram of the process by which the electrode assembly 3 of the pulse ablation catheter shrinks from a dome shape to a petal shape when it is engaged with the sheath 600.

[0053] Figure 16a This is a schematic diagram showing the catheter abutting against the pulmonary vein after the electrode assembly shrinks from a dome shape to a petal shape.

[0054] Figure 16b This is a schematic diagram showing the catheter abutting against the posterior wall of the left atrium after the electrode assembly shrinks from a dome shape to a petal shape. Detailed Implementation

[0055] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. Examples of the embodiments are shown in the drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, but should not be construed as limiting the present invention.

[0056] like Figure 1 As shown, this is a pulse ablation system provided in an embodiment of the present invention. The system includes a pulse device 100, which provides pulse energy for ablation. The pulse energy is a high-frequency, high-voltage biphasic electrical pulse with a pulse width of 0.1µs to 50µs and a voltage of 5V to 6000V. An electrocardiogram (ECG) detection device 300 is connected to the pulse device 100 to detect the patient's R wave and triggers the pulse device 100 to release pulse energy 50ms to 200ms after detecting the R wave. A high-voltage resistant tail wire 400 connects the pulse device 100 and the pulse ablation catheter 500 to transmit the pulse energy. The pulse device 100 also includes a display screen 200 for real-time display of the operation.

[0057] The pulse ablation catheter 500 includes a handle 1, a main tube 2, and an electrode assembly 3 connected in sequence. The handle 1 has a high-frequency, high-voltage resistant socket 501 at one end relative to the main tube 2. The handle 1 also has a Luer connector 502, which connects to the inner tube of the main tube 2 for guiding the guidewire or injecting saline. The main tube 2 is made of a biocompatible polymer material, such as polyurethane (PU) or block polyetheramide resin (e.g., Pebax). The end of the main tube 2 near the electrode assembly 3 has a flexible, bendable section 21, and a rigid section 22 connects the flexible, bendable section 21 to the electrode assembly 3.

[0058] Electrode assembly 3, such as Figure 2-4 As shown, the assembly includes multiple first cavities 31 evenly distributed in a radiating pattern in the center, with the first ends of each first cavity 31 located at the center of the electrode assembly. It also includes second cavities 32 arranged in a ring on the outer sides, with the second ends of the first cavities 31 connected to the second cavities 32. Both the first and second cavities 31 are made of flexible material, allowing them to bend and contract to fit with a sheath. The first cavities 31 have an arc-shaped linear structure with an upward convex center, extending between the center of the electrode assembly and the second cavities 32, and are evenly distributed circumferentially. Both the first and second cavities are hollow tubular components. The first and second cavities 31 are made of biocompatible polymer materials, such as polyurethane (PU) or Pebax. The number of first cavities 31 is 3-8, preferably 5-6.

[0059] Preferably, one end of the plurality of first cavities 31 located in the middle is connected to a fixing member 6.

[0060] Preferably, the second cavity 32 includes a plurality of arc segments 322, and the number of arc segments 322 is the same as the number of the first cavity 31. Each arc segment 322 connects the second end of the outer side of two adjacent first cavities 31, and thus the plurality of arc segments 322 form a ring.

[0061] The diameter of the annular ring formed by the second cavity 32 is D, and the size of D is 15mm-35mm. And as... Figure 2 , 3 As shown, the first cavity 31 is an upwardly convex arc shape relative to the second cavity 32. The first cavity 31 and the second cavity 32 form a dome-shaped structure. The height H of this structure varies depending on the number of first cavities and the curvature of the first cavities. This height H is generally 5mm-15mm, preferably 10mm.

[0062] Both the first cavity 31 and the second cavity 32 have annular electrodes distributed on their outer sides. The first cavity 31 has evenly spaced first annular electrodes 311, each with a length of 1mm-3mm. Each first cavity 31 has 1-5 first annular electrodes 311, and the spacing between them is the same, typically d1, which is 2mm-4mm. The number of second annular electrodes 321 on the second cavity 32 is adjusted according to the diameter D of the annulus formed by the second cavity, ranging from 10 to 20. The length of each second annular electrode 321 is 1mm-2mm, and the spacing d2 between them is the same. The spacing between second annular electrodes 321 located on the same arc segment, and the spacing between second annular electrodes 321 located on adjacent arc segments, are all the same.

[0063] The first ring electrode 311 and the second ring electrode 321 are made of platinum, platinum-iridium alloy, or gold, etc. The second ring electrode 321 has a small electrode size and a close electrode spacing, and is used to map electrocardiogram signals.

[0064] The electrode assembly 3 also includes an inner support member 4, which is located inside the first cavity 31 and the second cavity 32 to support them. Figure 5a , 5bAs shown in Figure 5c, the support member 4 consists of multiple linear components, the same number as the first cavity 31, and each support member 4 forms a petal shape. The support member 4 is made of nickel or nickel-titanium alloy. The support member 4 includes side portions 41 on both sides and a central portion 42 in the middle. The side portions 41 are arc-shaped linear structures that bulge upwards in the middle, with both ends bent downwards. The first ends of the two side portions 41 are close to each other but separated, forming a gap. The second ends of the side portions 41 are far apart and both connect to the central portion 42. The central portion 42 is located between the second ends of the two side portions 41, and the side portions 41 and the central portion 42 form a petal shape. Multiple support members 4 are arranged side-by-side to form a ring structure, as shown in Figure 5c. Figure 5c As shown, the side portions 41 of adjacent support members 4 are placed side by side, and the first cavity 31 is sleeved on the outside. The middle portion 42 of the support member 4 forms a ring, and the second cavity 32 is sleeved on the outside of the middle portion 42. Preferably, an arc-shaped segment 322 of the second cavity 32 is sleeved on the outside of the middle portion 42 of each support member 4.

[0065] The wire diameter of the middle portion 42 is larger than that of the side portion 41. Preferably, the wire diameter of the middle portion 42 is 1.5-2 times that of the side portion 41, so that the size of the adjacent support members 4 after the side portions 41 are placed side by side is close to the size of the middle portion 42. The adjacent support members 4 side portions 41 jointly support a first cavity 31, avoiding a decrease in the flexibility of the combined first cavity 31. The wire diameter of the support member 4 is in the range of 0.15mm-0.3mm to ensure that the second annular electrode on the second cavity better fits the pulmonary vein opening of the heart. Because the side portion and the middle portion are integrally formed, but their wire diameters are different, the support member 4 is a variable diameter wire.

[0066] like Figure 5a As shown, the side part 41 is an upwardly convex arc shape, with an arc C at the top of 30-180 degrees. Its outer side, that is, the second end connected to the middle part, forms an inwardly concave outward warping with a warping radius B of 5mm-20mm.

[0067] Figure 6a , 6b Option 6c represents another alternative to this support member. In this embodiment, the support member 4' has a first end of side portion 41' that bends downward and a second end that extends horizontally. In this case, the first cavity is a downwardly concave arc shape relative to the second cavity. The curvature C' of the side portion is less than... Figure 5a The arc C in the figure has a concave warp at its second end, and the warp radius B' at the second end is greater than... Figure 5a The warping radius B in the middle. Furthermore, the first ends of the two sides of the support member 4' are tightly joined together, and multiple support members 4' are arranged side-by-side to form a... Figure 6c The dome-shaped linear structure is shown. Similarly, the support member 4' is also a variable diameter wire.

[0068] Those skilled in the art will understand that the first cavity can be an arc shape that bulges upward relative to the second cavity, or an arc shape that is concave downward, forming a shape similar to unfolding flower petals.

[0069] A first cavity 31 is fitted onto the outer side of each pair of adjacent support members 4, and an arc-shaped segment 322 of a second cavity 32 is fitted onto the outer side of the middle portion 42 of each support member 4. Therefore, the outer diameter of the first cavity 31 is approximately 1mm-2.5mm, preferably 1mm-2mm; the outer diameter of the second cavity 32, i.e., the outer diameter of the arc-shaped segment 322, is 0.5mm-1.5mm, preferably 0.5mm-1.25mm. The inner diameter 31 of the first cavity is approximately 1.5-2 times the outer diameter of the second cavity 32, allowing adjacent ends of adjacent arc-shaped segments 322 to be inserted into the first cavity 31. Furthermore, the connection between the two is made using biocompatible adhesives such as polyurethane glue or UV glue.

[0070] like Figure 7a As shown, this illustrates the connection between the first cavity 31 and the second cavity 32. The end of the arc-shaped segment 322 of the second cavity 32 is inserted into the first cavity 31, and a biocompatible curing adhesive 51 is filled between the end of the arc-shaped segment 322 and the first cavity 31. Figure 7b As shown, another connection method is used for the first cavity 31 and the second cavity 32. The end of the arc-shaped segment 322 is inserted into the first cavity 31, and the connection is formed by heating and melting to form a molten body 52.

[0071] like Figure 8 , 9 As shown in Figure 10, Figure 8 This is a schematic diagram of the connection structure between the electrode assembly 3 and the main tube 2. The first ends of the first cavities 31 of the electrode assembly 3 are each inserted into the rigid section 22 of the main tube 2. Preferably, a fixing member 6 is provided within the rigid section 22, and the middle first ends of the plurality of first cavities 31 of the electrode assembly 3 are all connected to a fixing member 6. Figure 9 , 10As shown, the fixing member 6 is a cylindrical component with an inner tube hole 61 extending through its thickness at its axial center. Multiple insertion holes 62 are evenly distributed on the outer side of the inner tube hole 61, also penetrating the thickness of the fixing member 6. That is, both the insertion holes 62 and the inner tube hole 61 extend along the axial direction of the cylinder. The first end of the first cavity 31 and its inner support member 4 are inserted into the insertion hole 62. Therefore, the number of insertion holes 62 matches the number of the first cavities 31. Preferably, the fixing member 6 is made of biocompatible polymer materials such as PEEK or ceramics, with an outer diameter of 2.5mm to 3.2mm and a thickness (axial length Z) of 5mm to 8mm. During installation, after the first cavity 31, the second cavity 32 and the support 4 are installed, the first cavity 31 and the support 4 are inserted into the socket 62 respectively, and then the entire electrode assembly 3 is installed into the rigid section 22 of the main tube 2. In addition, glue can be injected into the gap between the fixing member 6 and the rigid section 22. The glue is also selected to be a biocompatible glue such as polyurethane.

[0072] Figure 11 The diagram shows a cross-sectional view of the main tube 2, which is a hollow structure with an inner tube 23 at its center. The inner tube 23 extends in the same direction as the main tube 2 and is a flexible braided tube, typically made of polyimide or Pebax. The inner cavity of the inner tube 23 can accommodate a guide wire with an outer diameter of 0.8 mm. A guide wire 24 is positioned between the outer side of the inner tube 23 and the inner wall of the main tube 2. A guide wire sheath 241 extending in the same direction as the guide wire is fitted over the outer side of the guide wire 24. Multiple guide wires 24 and guide wire sheaths 241 can be provided between the inner tube 23 and the main tube 2. One end of the guide wire 24 is connected to the first and second annular electrodes on the electrode assembly 3 via the main tube 2, and the other end is connected to the socket 501 on the handle. Between the outer side of the inner tube 23 and the inner wall of the main tube 2, there are also symmetrically arranged pull lines 25. The pull lines 25 are also provided with pull line protective tubes 251. The pull lines 25 enable the bendable section 21 to deflect in both directions within a range of ±45 degrees relative to the vertical direction, that is, to deflect in both directions within an angle of 90-135 degrees.

[0073] Pulse energy is transmitted from the pulse device 100 to the pulse ablation catheter 500 via the high-voltage tail wire 400, and then released to the electrode assembly 3 via the lead wire 24. This allows the pulse ablation energy to form an ablation focus at the target location, thereby blocking the transmission of abnormal electrical signals such as atrial fibrillation and atrial tachycardia. The selected pulse energy is a high-frequency, high-voltage, short pulse. This pulse energy can effectively cause irreversible electroporation of tissue cells. The voltage of the high-voltage short pulse is 5V to 6000V, and it is a monophasic or biphasic voltage with a pulse width of 0.1 to 50µs. The pulse energy needs to be released within the safe period of the cardiac cycle. The pulse is connected to the R-wave detection device 300, and the pulse energy is released 50ms to 200ms after the device 300 detects the R-wave.

[0074] The first and second ring electrodes on the electrode assembly 3 can be in bipolar discharge mode and unipolar discharge mode. In bipolar discharge mode, a pulsed electric field is formed between the ring electrodes, and the discharge form of the ring electrodes can selectively discharge according to the contact between the electrodes and the myocardium. In unipolar discharge mode, a pulsed electric field is formed between the ring electrodes on the electrode assembly and the back electrode plate attached to the patient's back. Figure 12a , 12b This is a schematic diagram of selective discharge of the annular electrode on electrode assembly 3 during bipolar discharge.

[0075] Figure 13a , Figure 13b The diagram shows the pulse ablation catheter 500 being delivered into the left atrium of the heart via a sheath 600. 601 represents the pulmonary vein orifice, and 602 is located on the posterior wall of the left atrium. Because the electrode assembly at the tip of the pulse ablation catheter is a flexible structure, after the catheter is inserted into the left atrium through the sheath, pushing the catheter causes the electrode assembly to take shape in the left atrium, forming a structure resembling... Figure 13b The dome-shaped structure in the lung is then ablated along with the pulmonary vein or posterior wall.

[0076] Figure 14a , 14b This is a schematic diagram showing the contact between the three parts of the electrode assembly of the pulse ablation catheter and the pulmonary vein and the posterior wall of the left atrium. Figure 14a , 14b In the diagram, 701 represents the pulmonary vein, 702 represents the guidewire, and 703 represents the posterior wall of the left atrium. When the electrode assembly 3 of the pulse ablation catheter 500 comes into contact with the pulmonary vein, after the catheter is shaped in the left atrium, the guidewire 702 is inserted into the pulmonary vein branch through the Luer interface 502, and then the catheter is advanced along the guidewire 702 to abut against the pulmonary vein. When ablating the posterior wall of the left atrium, the catheter is simply pushed directly to abut against the posterior wall. When in contact with the pulmonary vein or the posterior wall, the first cavities 31 in the electrode assembly 3 of the pulse ablation catheter 500 are interconnected through the second cavities 32, ensuring that the spacing between the first cavities 31 remains uniform.

[0077] Figures 15a-15f This refers to the process by which the electrode assembly 3 of the pulse ablation catheter contracts from a dome shape to a petal shape when it engages with the sheath 800. As the catheter 500 slowly retracts into the sheath 600, the shape of the electrode assembly 3 changes from a dome shape to a petal shape, with its annular diameter and dome height continuously decreasing. Its annular diameter D also continuously decreases to D1, as... Figure 15b As shown, depending on the requirements, D can also be shrunk to D2, such as... Figure 15cAs shown, its outer diameter changes, for example, from a dome-shaped radial dimension of 35 mm to a petal-shaped radial dimension of 18 mm. The spacing d2 between the second annular electrodes on the motor assembly 3 can also shrink to d21 or d22 as the outer diameter D shrinks, as... Figure 15b , 15c As shown, the spacing d2 between the second annular electrodes shrinks from 10 mm to 5 mm. The height H of the electrode assembly 3 also shrinks to H2 along with the outer diameter D, as... Figures 15d-15f As shown, the diameter shrinks from 15mm to 5mm. The first annular electrode 311 also shrinks as the outer diameter D shrinks, and the electrode spacing d1 continuously decreases. When the outer diameter shrinks to D2, the first annular electrode 311 is almost completely retracted into the sheath 800, as shown... Figure 15f As shown.

[0078] like Figure 16a , 16b The diagrams show the contact between the pulse ablation catheter and the pulmonary vein and the posterior wall of the left atrium after the electrode assembly shrinks from a dome shape to a petal shape. When the electrode assembly of the pulse ablation catheter becomes petal-shaped, its outer diameter can be shrunk to different diameters as needed, thereby allowing the second annular electrode and part of the first annular electrode to better fit with the heart tissue. The operator can change the catheter to the required shape according to the patient's cardiac physiological structure or electrode contact.

[0079] The pulse ablation catheter of the present invention has a dome-shaped electrode assembly. Combining the physiological structural characteristics of the pulmonary vein and the technical characteristics of pulse ablation, the dome-shaped electrode assembly can effectively adhere to the pulmonary vein or the posterior wall of the atrium. Furthermore, the dome-shaped electrode assembly can be transformed into a petal shape by cooperating with the sheath. The outer diameter of the petal shape can be selected to better adhere to the pulmonary vein or the posterior wall of the atrium. The dome-shaped or petal-shaped structure carrying more annular electrodes can safely and effectively improve the pulse ablation effect and save surgical time.

[0080] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature.

[0081] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0082] While specific embodiments of the present invention have been described above, those skilled in the art should understand that these are merely illustrative examples, and the scope of protection of the present invention is defined by the appended claims. Those skilled in the art can make various changes or modifications to these embodiments without departing from the principles and essence of the present invention, but all such changes and modifications fall within the scope of protection of the present invention.

Claims

1. A pulse ablation catheter, comprising a handle (1), a main tube (2), and an electrode assembly (3) connected in sequence, characterized in that, The electrode assembly (3) includes, Multiple first cavities (31) are located in the middle and are evenly distributed in a scattering pattern; The second cavity (32) is located on the outer side in a ring shape; It also includes a support member (4), which is disposed inside the first cavity (31) and the second cavity (32) to support the first cavity (31) and the second cavity (32); The first end of the plurality of first cavities (31) is located in the middle of the electrode assembly (3), and the second end located on the outside is connected to the second cavity (32). The plurality of first cavities (31) are arc-shaped upward or downward relative to the second cavity (32). The first cavity (31) is provided with a plurality of first annular electrodes (311) spaced apart, and the second cavity (32) is provided with a plurality of second annular electrodes (321) spaced apart; The second cavity (32) includes a plurality of arc segments (322), which connect the second ends of two adjacent first cavities (31); The support member (4) is a petal-shaped linear component, including side portions (41) on both sides and a middle portion (42) in the middle. The side portions (41) are arc-shaped linear structures. The first ends of the two side portions (41) are separated from each other, and the middle portion (42) is connected to the second ends of the two side portions (41) respectively.

2. The pulse ablation catheter as described in claim 1, characterized in that, The first end of the first cavity (31) is connected to a fixing member (6).

3. The pulse ablation catheter as described in claim 1, characterized in that, The number of the support members (4) is the same as the number of the first cavity (31). Multiple support members (4) are arranged in a ring in parallel. The two parallel side portions (41) of adjacent support members (4) jointly support the same first cavity (31). The middle portion (42) of the support member (4) is used to support the arc segment (322).

4. The pulse ablation catheter as described in claim 3, characterized in that, The diameter of the side portion of the support member (4) is smaller than that of the middle portion, and the side portion and the middle portion are integrally formed.

5. The pulse ablation catheter as described in claim 3, characterized in that, The outer diameter of the first cavity (31) is larger than the outer diameter of the second cavity (32), which facilitates the insertion of the end of the arc-shaped segment (322) into the first cavity (31).

6. The pulse ablation catheter as described in claim 1, characterized in that, The discharge modes of the first ring electrode and the second ring electrode are either bipolar discharge mode or unipolar discharge mode.

7. The pulse ablation catheter as described in claim 1, characterized in that: The number of the first cavity (31) is 3-8, the number of the first annular electrode (311) on the first cavity (31) is 1-5, and the number of the second annular electrode (321) on the second cavity (32) is 10-20.

8. The pulse ablation catheter as described in claim 1, characterized in that, The electrode assembly (3) is dome-shaped, with a radial dimension (D) of 15mm-35mm and a height (H) of 5mm-15mm.

9. The pulse ablation catheter as described in claim 2, characterized in that, The fixing member (6) is a cylindrical component with an inner tube hole (61) that penetrates its thickness at the center and is connected to the inner tube of the main tube. Multiple through insertion holes (62) are evenly distributed on the outer side of the inner tube hole (61), and the first end of the first cavity (31) is inserted into the insertion hole (62).

10. The pulse ablation catheter as described in any one of claims 1-9, characterized in that: One end of the main tube (2) is connected to the handle (1), and the other end is provided with a flexible bendable section (21). The flexible bendable section (21) and the electrode assembly (3) are connected to a rigid section (22). The first end of the first cavity (31) is inserted into the rigid section (22).

11. The pulse ablation catheter as described in any one of claims 1-9, characterized in that: The main tube (2) is a hollow tube with an inner tube (23) extending in the same direction on its inner side. A wire (24) and a pull wire (25) are provided in the gap between the inner tube (23) and the main tube (2).

12. The pulse ablation catheter as described in claim 11, characterized in that, The handle (1) is provided with a Luer interface (502), which is connected to the inner tube of the main tube (2) for guiding the guide wire or injecting saline; the handle is provided with a high-frequency high-voltage socket (501) at one end relative to the main tube.

13. A pulse ablation system, characterized in that, include, The pulse device (100) provides pulse energy for pulse ablation; An electrocardiogram (ECG) detection device (300), connected to a pulse device (100), is used to detect the patient's R wave and trigger the pulse device to release pulse energy; A pulse ablation catheter (500), wherein the pulse ablation catheter is any one of claims 1-12 above. It also includes a high-voltage tail wire (400) for connecting the pulse device (100) and the pulse ablation catheter (500) to transmit pulse energy.

14. The pulse ablation system as described in claim 13, characterized in that, The pulse energy provided by the pulse device is a high-frequency, high-voltage biphasic electrical pulse with a pulse width of 0.1us to 50us and a voltage of 5V to 6000V. The electrocardiogram detection device triggers the pulse device (100) to release the pulse energy 50ms to 200ms after detecting the R wave.

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