Pulse ablation device

By designing a double-layer ablation assembly in the pulse ablation device, effective attachment and ablation of the target tissue is achieved, and the problems of poor attachment and long ablation time in the prior art are solved, and the ablation effect and safety are improved.

CN119214768APending Publication Date: 2024-12-31SHANGHAI SHANGYANG MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202310778316.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-06-29
Publication Date
2024-12-31

AI Technical Summary

Technical Problem

The existing pulse ablation device cannot effectively adhere to the target tissue, resulting in poor ablation effect and long ablation time.

Method used

A double-layer ablation assembly including a first electrode assembly and a second electrode assembly is designed. By controlling the assembly, the first electrode assembly is attached to the inner wall of the target tissue, and the second electrode assembly is disposed at the target tissue entrance to achieve the target tissue. effective attachment and ablation.

Benefits of technology

It improves the ablation effect and shortens the ablation time, and reduces the risk of damage to adjacent tissues, especially in pulmonary veins and other parts, which can effectively isolate the atrial fibrillation lesions.

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Abstract

The invention discloses a pulse ablation device. The device comprises a tube body; the ablation assembly comprises a first electrode assembly and a second electrode assembly which are arranged on the tube body; wherein the first electrode assembly and the second electrode assembly are insulated from each other, and when the first electrode assembly enters a target tissue from an inlet of the target tissue, the second electrode assembly abuts against the inlet; the control assembly is connected with the ablation assembly and used for controlling the first electrode assembly to contract and unfold so that the first electrode assembly can be attached to the inner wall face of the target tissue. By operating the control assembly, the ablation assembly is controlled to be attached to the target tissue, the ablation effect is improved, and meanwhile the ablation time is shortened.
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Description

Technical Field

[0001] The present invention relates to the field of medical intervention, and in particular to a pulse ablation device. Background Art

[0002] Atrial fibrillation (AF) is the most common arrhythmia that is ablated. Although the procedure is largely safe and effective in the hands of professional operators, it is still associated with serious complications, including pulmonary vein stenosis, stroke, phrenic nerve paralysis, and the most terrible complication, esophageal atrial fistula, when it occurs, the mortality rate exceeds 50%. At present, catheter ablation mainly relies on the thermal effect of radiofrequency energy and the cold effect of cryoenergy. These ablation methods are not selective in destroying the tissue in the ablation area and rely on the adhesion force of the catheter. The ablation procedure takes a long time, so it may cause damage to the adjacent esophagus, phrenic nerve and blood vessels within the thermal range. In some special areas, there will also be interference from heart beats, respiratory movements, etc. Poor adhesion will cause incomplete isolation of the pulmonary veins and cause recurrence of atrial fibrillation.

[0003] In contrast, pulsed field ablation (PFA) is a non-thermal ablation method that preferentially ablates myocardial tissue, in contrast to all other ablative energy sources currently used for cardiac ablation, such as radiofrequency ablation, cryoablation, and laser ablation. In it, an ultrafast (<1 second) electric field is applied to the target tissue. The principle of pulse ablation is to form a large field strength between the positive and negative electrodes. Under the action of the field strength, the cell tissue forms irreversible nanoscale pores and the leakage of cell contents destroys the stability of the cell membrane, ultimately leading to cell death. PFA also has good tissue selectivity, and its threshold for myocardial damage is the lowest. It has a good protective effect on the vascular smooth muscle, esophagus, nerves, etc. around the heart, which can reduce or even eliminate the risk of accidental collateral damage and safety issues. At the same time, because the pulse releases energy in a short time and no thermal effect is generated during the discharge process, problems such as tissue damage and pulmonary vein stenosis are avoided. Summary of the invention

[0004] The technical problem to be solved by the present invention is to provide a pulse ablation device in order to overcome the defects in the prior art that the pulse ablation device cannot effectively adhere to the target tissue, resulting in poor ablation effect and long ablation time.

[0005] The present invention solves the above technical problems through the following technical solutions:

[0006] A pulse ablation device is provided, comprising:

[0007] tube body;

[0008] an ablation assembly, the ablation assembly comprising a first electrode assembly and a second electrode assembly disposed on the tube body; wherein the first electrode assembly and the second electrode assembly are insulated from each other, and when the first electrode assembly enters the target tissue from an entrance of the target tissue, the second electrode assembly abuts against the entrance;

[0009] A control component is connected to the ablation component and is used to control the contraction and expansion of the first electrode component so that the first electrode component is close to the inner wall surface of the target tissue.

[0010] Optionally, an insulating layer is provided between the first electrode assembly and the second electrode assembly;

[0011] and / or, an area of ​​the first electrode assembly close to the second electrode assembly is coated with an insulating material;

[0012] and / or, a side of the second electrode assembly close to the first electrode assembly is coated with an insulating material;

[0013] And / or, there is a gap between the first electrode assembly and the second electrode assembly.

[0014] Optionally, a diameter of the first electrode assembly is greater than a diameter of the second electrode assembly, and a discharge area of ​​the first electrode assembly is not greater than a discharge area of ​​the second electrode assembly.

[0015] Optionally, the first electrode assembly comprises at least two arc-shaped rods arranged circumferentially around the tube body and a plurality of first electrodes, wherein the plurality of first electrodes are arranged in an array on the arc-shaped rods;

[0016] And / or, the length of the first electrode ranges from 1 mm to 3 mm;

[0017] And / or, the interval between the first electrodes ranges from 1 mm to 4 mm.

[0018] Optionally, the first electrode assembly includes a grid sphere and a plurality of first electrodes; the first electrodes are arranged in an array on the grid sphere;

[0019] And / or, the length of the first electrode ranges from 1 mm to 3 mm;

[0020] And / or, the interval between the first electrodes ranges from 1 mm to 4 mm.

[0021] Optionally, the second electrode assembly includes a mesh curved surface and a plurality of second electrodes; the second electrodes are arranged in an array on the mesh curved surface;

[0022] And / or, the length of the second electrode ranges from 0.5 mm to 3 mm;

[0023] And / or, the interval between the second electrodes ranges from 1 mm to 4 mm.

[0024] Optionally, the second electrode assembly comprises a plurality of arc-shaped rods connected end to end and a plurality of second electrodes, and the second electrode array is arranged on the arc-shaped rods;

[0025] And / or, the length of the second electrode ranges from 0.5 mm to 3 mm;

[0026] And / or, the interval between the second electrodes ranges from 1 mm to 4 mm.

[0027] Optionally, the ablation component is made of platinum-iridium alloy;

[0028] And / or, the device further comprises an inner tube and a mapping catheter embedded in the tube body, wherein the mapping catheter passes through the inner tube for real-time mapping of intracardiac signals.

[0029] Optionally, the tube body comprises wire pulling cavities distributed on both sides of the tube body, and a wire pulling cavities are provided in the wire pulling cavities;

[0030] The control assembly includes a bidirectional bending control knob, the pull wire is used to control the bidirectional deflection of the adjustable bending section of the tube body by controlling the bidirectional bending control knob, and the pull wire cavity is used to provide a separate passage for the pull wire;

[0031] The tube body also includes an outer tube sleeved on the inner tube, and the wire drawing cavity is bonded to the outer tube.

[0032] Optionally, the tube body further includes a saline tube, and the saline tube is used to inject saline into the ablation component;

[0033] And / or, one end of the ablation device away from the ablation component is connected to a pulse device, and the pulse device is used to release pulse energy;

[0034] The first electrode assembly and / or the second electrode assembly are connected to the pulse device to form a pulse electric field.

[0035] On the basis of being in accordance with the common sense in the art, the above-mentioned preferred conditions can be arbitrarily combined to obtain the preferred embodiments of the present invention.

[0036] The positive and progressive effect of the present invention is that the device includes a double-layer ablation assembly including a first electrode assembly and a second electrode assembly, wherein the first electrode assembly is used to abut against the target tissue, and the second electrode assembly is used to abut against the entrance of the target tissue, and by operating the control assembly, the ablation assembly is controlled to abut against the target tissue, thereby improving the ablation effect and shortening the ablation time. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 A schematic diagram of the structure of a pulse ablation device provided by an embodiment of the present invention;

[0038] Figure 2 A first structural schematic diagram of an ablation component of a pulse ablation device provided by an embodiment of the present invention;

[0039] Figure 3 A second structural schematic diagram of an ablation component of a pulse ablation device provided by an embodiment of the present invention;

[0040] Figure 4 A third structural schematic diagram of an ablation component of a pulse ablation device provided by an embodiment of the present invention;

[0041] Figure 5 A fourth structural schematic diagram of an ablation component of a pulse ablation device provided by an embodiment of the present invention;

[0042] Figure 6 A fifth structural schematic diagram of an ablation component of a pulse ablation device provided by an embodiment of the present invention;

[0043] Figure 7 A schematic diagram of a cross-sectional structure of an adjustable curved section of a pulse ablation device provided by an embodiment of the present invention;

[0044] Figure 8 A schematic diagram of a first application scenario of a pulse ablation device provided by an embodiment of the present invention;

[0045] Fig. 9 A schematic diagram of a second application scenario of a pulse ablation device provided by an embodiment of the present invention;

[0046] Fig.10 A simulation schematic diagram of an ablation segment of a pulse ablation device provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0047] The present invention is further described below by way of examples, but the present invention is not limited to the scope of the examples.

[0048] Figure 1 A structural schematic diagram of a pulse ablation device provided in an embodiment of the present invention, the pulse ablation device includes a tube body 4, an ablation component and a control component 6, the ablation component includes a first electrode component 2 and a second electrode component 3 arranged on the tube body, when the first electrode component 2 enters the target tissue from the entrance of the target tissue, the second electrode component 3 is abutted against the entrance, wherein the first electrode component 2 and the second electrode component 3 are insulated; the control component 6 is connected to the ablation component, and is used for controlling the contraction and expansion of the first electrode component so that the first electrode component is close to the inner wall surface of the target tissue, thereby achieving ablation of the target tissue.

[0049] The pulse ablation device also includes a distal tip 1, a high-frequency and high-voltage resistant socket 9, a Luer interface 10, which is connected to the inner tube of the pulse ablation device and is used to pass a mapping catheter or a guide wire, and a three-way valve 11 for perfusing saline, wherein the distal end of the pulse ablation component is the end close to the ablation component, and the proximal end is the end away from the ablation component. Specifically, the tube body 4 is generally made of biocompatible polymer materials such as Pebax (nylon) and PU (polyurethane), and the curved and straight tubes 5 are made of polymer materials with good smoothness such as PTFE (polytetrafluoroethylene) and HDPE (high-density polyethylene). The control component 6 includes a two-way bending control knob 7 and a push-twist 8, which are used to control the contraction and expansion of the distal first electrode component 2.

[0050] The target tissue includes but is not limited to the pulmonary vein, and the pulse ablation device includes but is not limited to being used for treating atrial fibrillation.

[0051] The distal end of the pulse ablation device is composed of a double-layer ablation component of a first electrode component and a second electrode component, which can ensure that the inside of the target tissue and the mouth of the target tissue are in contact at the same time. The design of the double-layer ablation component can solve the problem of poor ablation effect caused by the size difference between the inside of the target tissue and the mouth of the target tissue. The first electrode component can extend to the inside of the pulmonary vein, and the second electrode component can be against the mouth of the pulmonary vein. They can cooperate well to ensure the contact effect, which can effectively save surgical time and improve the ablation effect. When the products in the prior art ablate the same part, it is necessary to rotate the catheter multiple times to form a complete closed ablation lesion, while the pulse ablation device provided by the embodiment of the present invention almost does not need to rotate the catheter, and can achieve a complete closed ablation lesion by direct ablation, thereby realizing the isolation of the target tissue.

[0052] In one embodiment, Figure 2 As shown, the first electrode assembly includes at least two arc-shaped rods 18 arranged circumferentially around the tube body and a plurality of first electrodes 17 , and the plurality of first electrodes 17 are arranged in an array on the arc-shaped rods.

[0053] Among them, for the convenience of understanding, the shape of the first electrode assembly provided in the embodiment of the present invention is called an "electrode ball" shape, the shape of the arc rod body 18 is formed by heat treatment of the internal support rod, and the material is mainly nickel or nickel-titanium alloy. The first electrode is arranged in an array on the arc rod body in a ring manner. The number of arc rods ranges from 4 to 6 rods, and each rod is provided with a first electrode arranged in an array. The first electrode spacing ranges from 1 mm to 4 mm, the number of first electrodes ranges from 4 to 6, and the preferred length of the first electrode ranges from 1 mm to 3 mm.

[0054] The single cavity on the arc-shaped rod is preferably made of polymer materials such as Pebax (nylon) and PU (polyurethane), and the outer diameter of the single cavity is preferably 1 mm to 2.5 mm.

[0055] In one embodiment, Figure 3 As shown, the first electrode assembly 2 includes a grid sphere and a plurality of first electrodes, and the first electrodes are arranged in an array on the grid sphere.

[0056] Among them, for the convenience of understanding, the shape of the first electrode assembly provided in the embodiment of the present invention is called a "grid ball" shape. The grid sphere is formed by laser yellow cutting. The length of the first electrode ranges from 1mm to 3mm, and the spacing of the first electrodes ranges from 1mm to 4mm.

[0057] The first electrode assembly includes two structural forms: a laser-cut grid-shaped structure and a ring-shaped electrode with an internal support structure. When the push knob 8 of the handle is pushed to the proximal end of the stroke slot, the sphere reaches its maximum diameter; when the push knob 8 of the handle is pushed to the distal end of the stroke slot, the sphere shrinks and the diameter is almost 0. The operator can operate the control handle to control the stroke by pushing and twisting the knob to shrink the sphere to an appropriate size to ensure effective contact with the inside of the pulmonary vein, thereby improving the ablation efficiency.

[0058] In one embodiment, Figure 2 As shown, the second electrode assembly 3 includes a mesh curved surface and a plurality of second electrodes, and the second electrodes are arranged in an array on the mesh curved surface.

[0059] Among them, for the convenience of understanding, the shape of the second electrode assembly provided in the embodiment of the present invention is called a "grid petal" shape. The mesh curved surface is formed by laser yellow cutting. The length of the second electrode ranges from 0.5mm to 3mm, and the spacing between the second electrodes ranges from 1mm to 4mm.

[0060] In one embodiment, Figure 4 As shown, the second electrode assembly includes a plurality of arc-shaped rods 20 connected end to end and a plurality of second electrodes 19, and the second electrodes 19 are arranged in an array on the arc-shaped rods.

[0061] Among them, for the convenience of understanding, the shape of the second electrode assembly provided in the embodiment of the present invention is called the "electrode petal" shape. The shape of the arc rod is formed by heat treatment of the internal support rod, and the material is mainly nickel or nickel-titanium alloy. The arc rod is spliced ​​end to end into a petal shape, and the second electrode is arranged in an array on the arc rod in a ring manner. The number of arc rods, i.e., petals, ranges from 4 to 6, and the number of electrodes arranged in an array on each arc rod is preferably 2 to 8. The length of the second electrode ranges from 0.5 mm to 3 mm, and the spacing between the second electrodes ranges from 1 mm to 3 mm.

[0062] Among them, the single cavity on the petal, that is, the arc-shaped rod 20 is preferably made of polymer materials such as Pebax, PU, ​​nylon, etc., and the outer diameter of the single rod is preferably 1mm to 2.5mm. Figure 5 In addition to the downward gathering shown, it also includes an upward gathering state. The petal structure is designed as an irregular arc structure according to the structure of the pulmonary vein mouth, and the angle of the petal arc is set according to the actual situation.

[0063] The second electrode assembly includes two structural forms: a laser-cut grid and a ring electrode with an internal support structure. The petal-shaped structural design can effectively fit against the pulmonary vein orifice, and the appropriate grid density and array electrode arrangement can ensure the uniformity of ablation.

[0064] The first electrode assembly and the second electrode assembly provided in the embodiment of the present invention can be freely combined into an ablation assembly, such as "grid ball + grid petals", or "grid ball + electrode petals", or "electrode ball + grid petals", or "electrode ball + electrode petals", and the preferred number of electrodes ranges from 10 to 40.

[0065] Take the grid ball + grid petals as an example. Figure 5 A top view of an ablation assembly composed of a "grid ball + grid petals" provided in an embodiment of the present invention, Figure 6 A side view of the ablation assembly composed of a "grid ball + grid petals" provided in an embodiment of the present invention, wherein the pulse ablation assembly includes a catheter distal tip 1, an inner tube 12, a grid ball, i.e. a first electrode assembly 2, and grid petals, i.e. a second electrode assembly 3, wherein AA is an adjustable bend section in the pulse ablation device.

[0066] Figure 2 The ablation assembly composed of "electrode ball + grid petals" provided in the embodiment of the present invention, 17 is the first electrode, 18 is the arc-shaped rod, and 3 is the second electrode assembly.

[0067] Figure 3 The ablation assembly composed of a "grid ball + electrode petals" provided in an embodiment of the present invention, 2 is a first electrode assembly, 19 is a second electrode, and 20 is an arc rod.

[0068] Figure 4 The ablation component composed of the "electrode ball + electrode petals" provided in the embodiment of the present invention, 17 is the first electrode, 18 is the arc-shaped rod body, 19 is the second electrode, and 20 is the arc-shaped rod.

[0069] The first electrode assembly provided in the embodiment of the present invention is the positive electrode of pulse discharge, and the second electrode assembly is the negative electrode of pulse discharge. The electrode ball and grid ball of the first electrode assembly are both spherical, the diameter at the equator of the spherical body is D1, the discharge area is S1, and the value range of D1 is 12mm~30mm. The electrode petals and grid petals of the second electrode assembly are both petal-like, the maximum plane unfolded diameter of the petal-shaped body is D2, the discharge area is S2, and the value range of D2 is 15mm~40mm. The electrode size is designed according to the differences in human pulmonary veins, so as to design different sphere diameters.

[0070] In one embodiment, the diameter of the first electrode assembly is greater than the diameter of the second electrode assembly, and the discharge area of ​​the first electrode assembly is not greater than the discharge area of ​​the second electrode assembly, that is, D1<D2, S2≤S1.

[0071] like Figure 8 As shown in the figure, taking the structural characteristics of the pulmonary vein as an example, when D1<D2, the sphere enters the interior of the pulmonary vein and petals against the vestibule (mouth) of the pulmonary vein. In this way, the lesion area formed by the discharge is the most ideal effect for pulmonary vein isolation. When S2≤S1, according to the structural characteristics of the pulmonary vein, the tissue thickness of the pulmonary vein mouth area is greater than the internal tissue thickness, that is, the ablation lesion depth requires the pulmonary vein mouth ≥ the internal part. The ablation lesion depth is positively correlated with the field strength. Combined with the principle of field strength distribution, it can be seen that when S2≤S1, a more effective pulmonary vein isolation effect can be achieved.

[0072] In one embodiment, insulation between the first electrode assembly and the second electrode assembly is achieved by at least one of the following methods: an insulating layer is provided between the first electrode assembly and the second electrode assembly, an insulating material is coated on an area of ​​the first electrode assembly close to the second electrode assembly, an insulating material is coated on one side of the second electrode assembly close to the first electrode assembly, and there is a gap between the first electrode assembly and the second electrode assembly.

[0073] Taking the example of coating an insulating material on an area of ​​the first electrode assembly close to the second electrode assembly to achieve insulation between the first electrode assembly and the second electrode assembly, specifically: the hemispherical part proximal to the spherical body of the first electrode assembly is insulated, wherein the insulating coating material can be selected from PTPE (polytetrafluoroethylene) coating, parylene coating, PI (polyimide) coating, etc., to ensure that the spherical body and the petal-shaped body are always insulated.

[0074] In one embodiment, the ablation component is made of platinum-iridium alloy.

[0075] In one embodiment, the pulse ablation device further includes an inner tube 12 and a mapping catheter embedded in the tube body. The mapping catheter is passed through the inner tube for real-time mapping of intracardiac signals. The intracardiac signals are mapped through electrodes on the arc or rod, and a guide wire is passed through the inner tube.

[0076] In one embodiment, Figure 7 As shown, Figure 7 It is a schematic diagram of the AA cross-sectional structure of the adjustable bend section of the pulse ablation device, the tube body includes a pull wire cavity 16 distributed on both sides of the tube body 4, a pull wire 15 is arranged in the pull wire cavity 16, the control component includes a two-way bending control knob, the pull wire 15 is used to control the two-way deflection of the adjustable bend section of the tube body 4 by controlling the two-way bending control knob, the pull wire cavity 16 is used to provide a separate passage for the pull wire 15, the tube body 4 also includes an outer tube sleeved on the inner tube 12, the pull wire cavity is bonded to the outer tube, 13 is a saline tube, 14 is an ablation catheter guide wire.

[0077] The inner tube is made of medical polymer materials with good flexibility, softness and elasticity, such as nylon (Pebax), polyester amine (TPU), etc. The wire pulling cavity is evenly distributed on both sides to provide a separate passage for the wire pulling. The wire pulling cavity is made of PTFE (polytetrafluoroethylene). The wire pulling cavity wraps the wire pulling to prevent the wire pulling stress from being concentrated and bent or broken. The wire pulling cavity and the outer tube are bonded together by hot melting or reflow (soft melting welding), which plays a role in protecting the wire pulling and reducing the friction between the wire pulling and the outer tube. The two bending control wires pass through the two through holes of the multi-lumen tube and are connected to the control end of the handle. The bidirectional deflection of the adjustable bending section of the catheter is achieved through the bending control knob, and the electrode wire transmits pulse energy.

[0078] In one embodiment, Figure 7 As shown, the tube body also includes a saline tube 13, which is used to infuse saline into the ablation component. The saline tube is preferably made of PI, PTFE or other materials, and is connected to the infusion pump through a three-way valve. During the use of the catheter, the saline tube is circulated and infused to the distal end of the catheter at a speed of 2ml / min to 10ml / min, wherein the infusion speed is a preferred range provided in an embodiment of the present invention, and the specific speed is set according to the actual situation.

[0079] In one embodiment, one end of the ablation device away from the ablation component is connected to a pulse device, the pulse device is used to release pulse energy, and the first electrode component is connected to the pulse device to form a pulse electric field.

[0080] In one embodiment, one end of the ablation device away from the ablation component is connected to a pulse device for releasing pulse energy, and the second electrode component is connected to the pulse device to form a pulse electric field.

[0081] In one embodiment, one end of the ablation device away from the ablation component is connected to a pulse device for releasing pulse energy, and the first electrode component and the second electrode component are connected to the pulse device to form a pulse electric field.

[0082] The pulse energy device outputs a high-voltage, short-pulse-width pulse waveform with an output voltage of 500V to 2000V and a pulse width of 0.1us to 50us. The pulse energy is released during the absolute refractory period of the cardiac cycle. The pulse device has the function of detecting the R wave, and generally releases the pulse energy about 50ms to 200ms after the start of the R wave is detected. During the pulse ablation process, bipolar discharge can be selected, that is, the spherical electrode and the petal-shaped electrode at the farthest end of the catheter are respectively connected to the positive and negative power supplies of the pulse, and a discharge circuit is formed between the electrodes. Single-pole discharge can also be selected, that is, either the spherical or petal-shaped electrode at the farthest end of the catheter is connected to the positive, and the back plate attached to the patient is connected to the negative, thereby forming a pulse electric field. Compared with single-pole discharge, bipolar discharge can reduce muscle stimulation of the patient.

[0083] Figure 8 and Fig. 9 A schematic diagram of a catheter provided in an embodiment of the present invention being attached to a pulmonary vein is provided. The operator uses the catheter in conjunction with a sheath to deliver the catheter to the left atrial pulmonary vein 21 of the heart and unfold it into the shape shown in the diagram, so that the spherical and petal shapes of the catheter are completely attached to the inside and mouth of the pulmonary vein respectively. The catheter is usually connected to a pulse device at the proximal end through a socket 9 at the end of the handle, which is used to transmit pulse ablation energy to the distal electrode of the catheter, so that a lesion is formed at the target ablation site.

[0084] Fig.10 It is a simulation schematic diagram of the ablation section, showing a schematic diagram of the ablation area obtained by discharging a grid ball + grid petals as the positive and negative poles respectively and connected to a pulse device, including an ablation area 101, a distal electrode 102, and a proximal electrode 103. Since they are evenly distributed over a long distance in the axial direction, the ablation width in the axial direction can be expanded. The distal grid ball as a whole acts as one polarity, and the proximal grid as a whole acts as one polarity, which increases the electrode area of ​​a single polarity, and is beneficial to increasing the ablation depth and the uniformity of the ablation focus.

[0085] The ablation catheter provided in the embodiment of the present invention is designed as a combination structure of "spherical" + "petal-shaped". Combined with the structural characteristics that there is a large difference in size between the inside of the pulmonary vein and the mouth of the pulmonary vein, the "spherical" + "petal-shaped" combination structure design can not only effectively solve the problem that the existing catheter types are easily deformed during ablation operations in the body, but also can effectively adhere to the inside and mouth of the pulmonary vein at the same time, and can allow the operator to complete the isolation of a pulmonary vein by selecting the position of the pulmonary vein once and outputting short-term pulse energy or radio frequency energy, which can not only shorten the operation time, improve the ablation effect, but also reduce the burden on patients.

[0086] Although the specific embodiments of the present invention are described above, it should be understood by those skilled in the art that this is only for illustration and the protection scope of the present invention is defined by the appended claims. Those skilled in the art may make various changes or modifications to these embodiments without departing from the principles and essence of the present invention, but these changes and modifications all fall within the protection scope of the present invention.

Claims

1. A pulse ablation device, characterized in that: The device comprises: tube body; an ablation assembly, the ablation assembly comprising a first electrode assembly and a second electrode assembly disposed on the tube body; wherein the first electrode assembly and the second electrode assembly are insulated from each other, and when the first electrode assembly enters the target tissue from an entrance of the target tissue, the second electrode assembly abuts against the entrance; A control component is connected to the ablation component and is used to control the contraction and expansion of the first electrode component so that the first electrode component is close to the inner wall surface of the target tissue.

2. The device according to claim 1, characterized in that An insulating layer is provided between the first electrode assembly and the second electrode assembly; and / or, an area of ​​the first electrode assembly close to the second electrode assembly is coated with an insulating material; and / or, a side of the second electrode assembly close to the first electrode assembly is coated with an insulating material; And / or, there is a gap between the first electrode assembly and the second electrode assembly.

3. The device according to claim 1, characterized in that A diameter of the first electrode assembly is greater than a diameter of the second electrode assembly, and a discharge area of ​​the first electrode assembly is not greater than a discharge area of ​​the second electrode assembly.

4. The device according to claim 1, characterized in that The first electrode assembly comprises at least two arc-shaped rods arranged circumferentially around the tube body and a plurality of first electrodes, wherein the plurality of first electrodes are arranged in an array on the arc-shaped rods; And / or, the length of the first electrode ranges from 1 mm to 3 mm; And / or, the interval between the first electrodes ranges from 1 mm to 4 mm.

5. The device according to claim 1, characterized in that The first electrode assembly includes a grid sphere and a plurality of first electrodes; the first electrodes are arranged in an array on the grid sphere; And / or, the length of the first electrode ranges from 1 mm to 3 mm; And / or, the interval between the first electrodes ranges from 1 mm to 4 mm.

6. The device according to claim 1, characterized in that The second electrode assembly includes a mesh curved surface and a plurality of second electrodes; the second electrodes are arranged in an array on the mesh curved surface; And / or, the length of the second electrode ranges from 0.5 mm to 3 mm; And / or, the interval between the second electrodes ranges from 1 mm to 4 mm.

7. The device according to claim 1, characterized in that The second electrode assembly includes a plurality of arc-shaped rods connected end to end and a plurality of second electrodes, and the second electrode array is arranged on the arc-shaped rods; And / or, the length of the second electrode ranges from 0.5 mm to 3 mm; And / or, the interval between the second electrodes ranges from 1 mm to 4 mm.

8. The device according to claim 1, characterized in that The ablation component is made of platinum-iridium alloy; And / or, the device further comprises an inner tube and a mapping catheter embedded in the tube body, wherein the mapping catheter passes through the inner tube for real-time mapping of intracardiac signals.

9. The device according to claim 8, characterized in that The tube body comprises wire pulling cavities distributed on both sides of the tube body, and a wire pulling cavities are provided in the wire pulling cavities; The control assembly includes a bidirectional bending control knob, the pull wire is used to control the bidirectional deflection of the adjustable bending section of the tube body by controlling the bidirectional bending control knob, and the pull wire cavity is used to provide a separate passage for the pull wire; The tube body also includes an outer tube sleeved on the inner tube, and the wire drawing cavity is bonded to the outer tube.

10. The device according to claim 1, characterized in that The tube body also includes a saline tube, which is used to inject saline into the ablation component; And / or, one end of the ablation device away from the ablation component is connected to a pulse device, and the pulse device is used to release pulse energy; The first electrode assembly and / or the second electrode assembly are connected to the pulse device to form a pulse electric field.

Citation Information

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