An ablation catheter and ablation system

Abstract

The present application relates to the field of medical devices, and provides an ablation catheter and an ablation system comprising the same, the ablation catheter comprising a penetrating part, an ablation main body, a catheter main body and a control handle connected in sequence; the penetrating part comprises a screwing-in member capable of screwing into and being fixed to a target tissue under the action of an external force; the ablation main body comprises an ablation electrode, a connecting member and a temperature sensor; the catheter main body comprises a non-ablation electrode and a perfusion channel; the non-ablation electrode is arranged in a spaced manner with the ablation electrode, and the non-ablation electrode is not in contact with the target tissue during ablation. By using the ablation catheter and the ablation system, the thickened interventricular septum is screwed and ablated, the screwing speed is easier to control, the depth can be stopped or adjusted in time before penetrating the myocardial wall, myocardial perforation can be prevented, and the damage to the myocardial tissue is reduced through temperature detection and perfusion function.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an ablation catheter and ablation system. Background Technology

[0002] Hypertrophic cardiomyopathy (HCM) is a cardiomyopathy characterized by asymmetric thickening of the heart. Typically, the thickening primarily affects the left ventricle, with the interventricular septum being the most prominent feature. Other less common types include apical hypertrophy, homogeneous hypertrophy, and left ventricular anterior wall hypertrophy. It is a hereditary cardiomyopathy caused by mutations in genes encoding sarcomere / sarcomere-associated structural proteins. On ultrasound, the main finding is left ventricular wall thickening, usually defined as a ≥15 mm thickness of the interventricular septum or left ventricular wall measured by two-dimensional echocardiography, or a thickness ≥13 mm in individuals with a clear family history. It is usually not accompanied by left ventricular cavity enlargement. Some patients with severe interventricular septal hypertrophy may experience left ventricular outflow tract obstruction, leading to hemodynamic disturbances.

[0003] Currently, treatment options for hypertrophic cardiomyopathy (HCM) include medication and surgery. The ultimate treatment strategy for refractory HCM is ventricular septal reduction surgery, but its application is limited by surgical trauma and high technical requirements. Coronary chemoablation is a first-line minimally invasive alternative to ventricular septal reduction surgery for some patients, but it heavily relies on the anatomy of the ventricular septal artery. Recently, endocardial and intramyocardial radiofrequency ablation has begun to be used to eliminate left ventricular outflow tract (LVOT) obstruction in HCM patients.

[0004] Existing technologies have disclosed ablation protocols for treating hypertrophic obstructive cardiomyopathy, which generally target hypertrophic ventricular septa with a thickness of 10-20 mm caused by hypertrophic cardiomyopathy. However, clinically, patients may have even thicker ventricular septa, with thicknesses reaching up to 30 mm. In such cases, the ablation catheters used in existing technologies cannot guarantee the overall ablation effect.

[0005] Meanwhile, in existing treatment protocols, the detection of the ventricular septum in experiments relies on expensive 3D imaging / CT imaging equipment, which is not conducive to the widespread use of ventricular septal pulse ablation catheters. Smaller medical institutions cannot guarantee the availability of such equipment. In the absence of such equipment, how to enable the operator to clearly understand the condition of the ventricular septum and clearly locate the ventricular septal pulse ablation catheter is also one of the technical problems that need to be solved in the current technology. Summary of the Invention

[0006] To address the aforementioned technical problems in the prior art, the present invention aims to provide an ablation catheter for treating hypertrophic cardiomyopathy and an ablation system comprising the aforementioned ablation catheter. This system can be used with simple imaging equipment to determine the location of the ablation catheter and exhibits better ablation effects for more hypertrophic ventricular septa. Furthermore, the ablation catheter of the present invention causes less damage to normal myocardial tissue during removal.

[0007] To achieve the above objectives, the technical solution of the present invention is as follows:

[0008] One aspect of the present invention provides an ablation catheter, comprising an insertion portion, an ablation body, a catheter body, and a control handle connected in sequence;

[0009] in,

[0010] The insertion part includes a screw-in member, which can be rotated and drilled into and fixed into the target tissue under the action of external force. The screw-in member is in the shape of a three-dimensional spiral or a screw, and the end away from the ablation body is a pointed tip.

[0011] The ablation body includes an ablation electrode, a connector, and a temperature sensor. The ablation electrode has a first end connected to the screw-in member, a first cavity disposed opposite to the first end, a second cavity extending from the first cavity toward the first end, and an infusion hole penetrating the circumferential surface of the ablation electrode. The connector is disposed in the first cavity. One end of the connector near the catheter body extends out of the first cavity and is connected to the catheter body. The connector has an axially penetrating first channel. The first channel communicates with the second cavity, the infusion hole, and the infusion channel in the catheter body. The connector and the inner wall of the first cavity form a plurality of second channels. The temperature sensor is located in one of the second channels.

[0012] The catheter body includes a non-ablation electrode and the infusion channel. The non-ablation electrode is spaced apart from the ablation electrode. During ablation, the non-ablation electrode does not come into contact with the target tissue.

[0013] Preferably, the position information of the ablation electrode is provided by the impedance difference between the ablation electrode and the non-ablation electrode.

[0014] More preferably, the pitch of the screw-in member gradually decreases from the distal end to the proximal end, and the pitch of the screw-in member is 0.25-1.5 times the diameter of the screw-in member.

[0015] More preferably, the diameter of the screw-in member gradually decreases from the proximal end to the distal end.

[0016] Preferably, the first end of the ablation electrode has a third cavity, and the screw-in member is connected to the third cavity. The screw-in member is telescopically connected to the third cavity, and the length of the screw-in member is less than or equal to the axial length of the third cavity.

[0017] Preferably, the extended portion further includes an insert, the length of which is less than or equal to the length of the screw-in member, the insert being fitted inside the screw-in member and not in contact with the screw-in member.

[0018] More preferably, the insert is a hollow structure and has a through hole penetrating the circumferential surface of the insert, and the proximal end of the insert communicates with the second cavity.

[0019] Preferably, the injection holes are configured in multiple groups, and the multiple groups of injection holes are distributed at intervals along the axial direction of the ablation electrode on the outer peripheral surface of the second cavity. The projection portions of two adjacent injection holes on a plane perpendicular to the axial direction of the ablation electrode overlap.

[0020] Preferably, the ablation body further includes a positioning sensor configured to sense the position of the ablation catheter in the target tissue, wherein the temperature sensor and the positioning sensor are located in different second channels.

[0021] Preferably, the ablation catheter further includes a guide, the guide including a connecting portion, a guiding portion and a guide hole penetrating the connecting portion and the guiding portion, the connecting portion being connected to the ablation catheter, the inner wall of the guiding portion being in the shape of a funnel with a diameter that gradually decreases from one end away from the connecting portion to one end near the connecting portion, and the guide hole communicating with the lining wire channel in the ablation catheter.

[0022] More preferably, the guide further includes a gripping portion located between the connecting portion and the guide portion, and the guide hole extends through the connecting portion, the gripping portion, and the guide portion.

[0023] Another aspect of the present invention provides an ablation system, including the above-mentioned ablation catheter, an integrated ablation device, a perfusion device, and an imaging device. The integrated ablation device is connected to the ablation catheter, the perfusion device, and the imaging device, respectively. The perfusion device is connected to the ablation catheter. The integrated ablation device includes an ablation generation module, a temperature detection module, an impedance detection module, an ECG signal detection module, an electrical stimulation / pacing signal module, an MCU central control module, an interactive control module, and an ablation control switch.

[0024] The ablation generation module is used to generate and send ablation energy to the ablation electrode;

[0025] The temperature detection module is used to receive the signal from the temperature sensor and feed it back to the MCU central control module;

[0026] The impedance detection module is used to detect the impedance of the ablation electrode and / or the non-ablation electrode, and feed it back to the MCU central control module;

[0027] The ECG signal detection module is used to detect electrocardiogram signals and feed them back to the MCU central control module;

[0028] The electrical stimulation / pacing signal module is used to generate and transmit electrical stimulation / pacing signals through the ablation electrode under the control of the MCU central control module.

[0029] The MCU central control module is signal-connected to the ablation generation module, the temperature detection module, the impedance detection module, the ECG signal detection module, the electrical stimulation / pacing signal module, the interactive control module, the ablation control switch, the ablation catheter, the perfusion device, and the imaging device. It is used to receive information from other modules, process it, and provide feedback and / or display the processed information.

[0030] The interactive control module is used to display information and accept control commands from the user;

[0031] The ablation control switch is used to control the application of ablation energy to the target tissue.

[0032] Another aspect of the present invention provides an ablation system, comprising at least two ablation catheters, an integrated ablation device, a perfusion device, and an imaging device, wherein the integrated ablation device is connected to the two ablation catheters, the perfusion device, and the imaging device respectively, and the perfusion device is connected to the two ablation catheters respectively. The integrated ablation device includes an ablation generation module, a temperature detection module, an impedance detection module, an ECG signal detection module, an electrical stimulation / pacing signal module, an MCU central control module, an interactive control module, and an ablation control switch.

[0033] The ablation generation module is used to generate and send ablation energy to each of the ablation electrodes;

[0034] The temperature detection module is used to receive signals from each of the temperature sensors and feed them back to the MCU central control module;

[0035] The impedance detection module is used to detect the impedance of each of the ablation electrodes and / or the non-ablation electrodes, and feed it back to the MCU central control module;

[0036] The ECG signal detection module is used to detect electrocardiogram signals and feed them back to the MCU central control module;

[0037] The electrical stimulation / pacing signal module is used to generate and transmit electrical stimulation / pacing signals through each of the ablation electrodes under the control of the MCU central control module.

[0038] The MCU central control module is signal-connected to the ablation generation module, the temperature detection module, the impedance detection module, the ECG signal detection module, the electrical stimulation / pacing signal module, the interactive control module, the ablation control switch, the two ablation catheters, the perfusion device, and the imaging device. It is used to receive information from other modules, process it, and provide feedback and / or display the processed information.

[0039] The interactive control module is used to display information and accept control commands from the user;

[0040] The ablation control switch is used to control the application of ablation energy to the target tissue.

[0041] Preferably, the ablation system further includes a position detection module, which receives signals from the positioning sensor and feeds them back to the MCU central control module.

[0042] The main beneficial effects achieved by this invention are as follows:

[0043] 1. Current ablation catheter positioning requires hospitals to have complete 3D mapping systems, which cost millions of yuan, making them unaffordable for ordinary basic hospitals and hindering the development of ablation surgery. The ablation catheter of this invention, through the combination of ablation and non-ablation electrodes (e.g., impedance detection of impedance differences between two electrodes, changes in electrocardiogram signals, etc.) and / or positioning sensors, can be inserted and its position determined under the guidance of the simplest imaging equipment. This significantly reduces the basic requirements for performing the surgery, lowers the learning curve for doctors, expands the scope of beneficiaries, and facilitates widespread adoption.

[0044] 2. In existing technologies, if the insertion depth of the insert exceeds its own length in a single insertion, there is a high probability that some myocardial tissue will adhere to it during retrieval, causing some damage to the interventricular septum. The inventors aim to minimize the extent of this damage. In one embodiment of the invention, the inventors optimized the configuration of the insert, making the conical spiral structure easier to insert and remove. In another embodiment, the inventors optimized the spiral structure of the insert, limiting the relationship between its pitch and diameter to ensure a stable insertion process and prevent the removal of target tissue during retrieval, thus avoiding excessive damage.

[0045] By using the ablation catheter and ablation system of the present invention, hypertrophic cardiomyopathy can be treated more simply and effectively, especially for patients with an interventricular septum thickness of 20 mm or more, with superior therapeutic effects and reduced damage to myocardial tissue. At the same time, the ablation catheter and ablation system of the present invention are lower in cost and have a wider range of applications. Attached Figure Description

[0046] Figure 1 This is a schematic diagram of the structure of an ablation catheter according to one embodiment of the present invention;

[0047] Figure 2 This is a partial structural schematic diagram of an ablation catheter according to one embodiment of the present invention;

[0048] Figure 3 This is a schematic diagram of the screw-in part 11;

[0049] Figure 4 This is a schematic diagram of the structure of an insert according to one embodiment of the present invention;

[0050] Figure 5 This is a schematic diagram of the structure of an insert according to one embodiment of the present invention;

[0051] Figure 6 This is a schematic diagram of the structure of an ablation electrode according to one embodiment of the present invention;

[0052] Figure 7 This is a schematic diagram of the injection hole structure;

[0053] Figure 8 This is a schematic diagram of the structure of a connector according to one embodiment of the present invention;

[0054] Figure 9 This is a schematic diagram of the structure of the ablation body according to one embodiment of the present invention;

[0055] Figure 10 This is a schematic diagram of the structure of the ablation body according to one embodiment of the present invention;

[0056] Figure 11 This is a schematic diagram of the ablation body and catheter body according to one embodiment of the present invention;

[0057] Figure 12 This is a schematic diagram of the structure of a guide element according to one embodiment of the present invention;

[0058] Figure 13 This is a schematic diagram of the structure of a guide element according to one embodiment of the present invention;

[0059] Figure 14 This is a partial schematic diagram of an ablation catheter according to one embodiment of the present invention;

[0060] Figure 15 This is a schematic diagram showing the impedance change of the ablation electrode at different positions;

[0061] Figure 16 A schematic diagram illustrating the determination of the ablation range using electrocardiogram signals;

[0062] Figure 17 This is a schematic diagram of an ablation system according to one embodiment of the present invention;

[0063] Figure 18 A schematic diagram illustrating the use of an ablation system according to one embodiment of the present invention;

[0064] Figure 19 This is a schematic diagram of an ablation system according to one embodiment of the present invention;

[0065] Figure 20 This is a schematic diagram showing the location of the ablation catheter in the heart.

[0066] Figure 21 Electrocardiograms in lead V1 when the ablation catheter is in different positions. Detailed Implementation

[0067] definition

[0068] Distal side: In this specification, when the device familiar with the present invention is referred to as "distal side", the term means the side that is relatively far away from the user.

[0069] Proximal side: In this specification, when the device familiar with the present invention is referred to as "proximal side", the term means the side that is relatively closer to the user.

[0070] Remote end: In this specification, when the term "remote end" is used to describe the system or apparatus of the present invention, the term generally refers to the end that is relatively far away from the user.

[0071] Proximal end: In this specification, when the term "proximal end" is used to describe the system or apparatus of the present invention, the term generally refers to the end that is relatively close to the user.

[0072] The terms "installation," "connection," "linking," and "fixing" 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, unless otherwise explicitly defined. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0073] Preferred embodiments of the present invention are described below with reference to the accompanying drawings. Those skilled in the art should understand that the embodiments or examples described below with reference to the drawings are only for illustrating the best ways to implement the present invention, and are not intended to limit the scope of the present invention to these embodiments. Various improvements and variations can be made to the present invention based on the following embodiments. All such improvements and variations are included within the scope of the present invention.

[0074] Figure 1 and Figure 2 An ablation catheter 10 according to one embodiment of the present invention is provided, comprising an insertion portion 1, an ablation body 2, a catheter body 3, and a control handle 4 connected sequentially from distal to proximal. The catheter body 3 includes a non-ablation electrode 31, which is spaced apart from the ablation electrode on the ablation body 2. During ablation, the non-ablation electrode 31 does not contact the target tissue. The insertion portion 1 includes a screw-in member 11 (…). Figure 4 The screw-in part 11 can rotate and be fixed into the target tissue under the action of external force, thereby fixing the ablation catheter 10 at the target ablation position and preventing the ablation catheter 10 from shifting position during the ablation of the target tissue, which could damage other non-target tissues or affect the ablation effect. The ablation body 2 includes an ablation electrode 21 as a shell, a connector 22, and a temperature sensor 23. Figure 9-10 The ablation electrode 21 has a first end connected to the screw-in member 11, a first cavity 211 disposed opposite to the first end, a second cavity 212 formed by extending from the first cavity 211 toward the first end, and an injection hole 213 penetrating the axial surface of the ablation electrode 21. Figure 6 The ablation electrode 21 is made of conductive material and is configured to contact the target tissue and emit ablation energy, such as radio frequency energy or pulse energy, to ablate the target tissue. The ablation electrode 21 can be inserted into the target tissue along with the insertion part 1 or abut against the surface of the target tissue to ablate the target tissue. The connector 22 is used to connect the ablation body 2 and the catheter body 3. The temperature sensor 23 is used to sense the temperature of the ablation electrode 21. Based on the measured temperature data, the power of the ablation electrode 21 can be adjusted in a timely manner to ensure that the temperature of the ablation site is relatively stable while not exceeding the threshold, preventing heat accumulation during the ablation process and preventing the temperature from becoming too high, i.e., preventing eschar formation in the surrounding tissue due to excessive electrode temperature, which could cause damage to the human body. The type of temperature sensor 23 is not particularly limited. In one embodiment of the present invention, the temperature sensor 23 is a thermocouple that senses the temperature of the ablation catheter 10. In a preferred embodiment of the present invention, the temperature sensor 23 is a K / T / J type thermocouple. In the specification of this invention, Figure 1 The X-axis direction is the axial direction of the ablation catheter 10 of the present invention.

[0075] The insertion part 1 includes a screw-in member 11, such as Figure 3As shown in Figure A, the screw-in member 11 is a three-dimensional helix, with the end of the screw-in member 11 furthest from the ablation body 2 being a pointed tip. The catheter body 3 is configured to rotate the screw-in member 11 under external force to drill into and fix it within the target tissue. Because the end of the screw-in member 11 furthest from the catheter body 3 is pointed, it allows the screw-in member 11 to penetrate the target tissue more easily. Furthermore, due to its three-dimensional helix shape, when the screw-in member 11 penetrates the target tissue, it can resist the surrounding target tissue, preventing the ablation electrode 21 from moving axially or radially, thus reliably fixing the screw-in member 11 within the target tissue. After ablation of one target tissue point, the screw-in member 11 can be unscrewed through the catheter body 3 to detach it from the target tissue, and then the screw-in member 11 can be reused to drill into the next target point for ablation, until all target tissue points have been ablated.

[0076] Furthermore, such as Figure 2 As shown, in some embodiments, the ablation body 2 is generally cylindrical, and the screw-in member 11 can extend in a three-dimensional spiral shape along the axial direction away from the ablation body 2 of the cylindrical ablation body 2, and as... Figure 3 As shown, the end of the screw-in member 11 furthest from the ablation electrode 21 can be a pointed tip. The screw-in member 11 can rotate under the drive of the catheter body 3 to penetrate and fix itself into the target tissue. Optionally, the tip of the screw-in member 11 can be conical, or it can be other sharper shapes obtained by grinding the end face of the free end of the screw-in member 11, such as a thin sheet. In other words, the shape of the tip of the screw-in member 11 is not limited; its purpose is to make it easier for the screw-in member 11 to penetrate the target tissue.

[0077] In one embodiment of the present invention, the wire diameter of the screw-in part 11 is 0.1-0.4 mm, preferably 0.15-0.3 mm, the diameter is between 0.5-2 mm, and the number of spiral turns is between 2-10. In a preferred embodiment, the length of the screw-in part 11 is 1-8 mm, more preferably 3 mm. In a preferred embodiment, the pitch of the screw-in part 11 is greater than or equal to 0.25 times the diameter of the screw-in part 11 and less than or equal to 1.5 times the diameter of the screw-in part 11; preferably, the pitch of the screw-in part 11 is 0.8 times the diameter of the screw-in part 11. When the pitch of the screw-in part 11 is less than 0.25 times the diameter, it is difficult to screw into the myocardial tissue, which is not conducive to fixation, and the target tissue brought out during screwing out increases, causing excessive damage. On the other hand, if the ratio between the pitch and the diameter of the screw-in part 11 is too large, it will cause shaking and instability during the screwing process if the material hardness of the screw-in part 11 remains unchanged. By optimizing the ratio between the pitch and diameter of the screw-in part 11, the present invention can reduce damage to the target tissue while facilitating the screw-in part 11 to be screwed into the target tissue.

[0078] In one embodiment of the invention, the screw-in member 11 is cylindrical and helical; in another embodiment, the screw-in member 11 is conical and helical, meaning the diameter of the screw-in member 11 gradually decreases from the proximal end to the distal end. When the screw-in member 11 is conical and helical, it is easier to screw into the target tissue and can reduce damage to the target tissue.

[0079] In other embodiments, the screw-in member 11 may also have a screw-like structure, that is, the main body is cylindrical, and at least one spiral-shaped sharp protrusion is spiraled on its outer circumferential surface. Figure 3 B).

[0080] Furthermore, in one embodiment of the present invention, the pitch of the screw-in member 11 is variable, that is, the pitch gradually decreases from the distal end to the proximal end. This arrangement is more conducive to the distal end of the screw-in member 11 drilling into the target tissue, and the proximal end is more securely fixed to the electrode.

[0081] It should be noted that, during the treatment process, in some embodiments, the user can operate the catheter body 3 to adjust the depth of the insertion element 11 into the target tissue according to actual needs, thereby better performing ablation treatment. In other embodiments, the user can also operate the control handle 4 exposed outside the patient's body to drive the catheter body 3 and the ablation body 2 connected to the catheter body 3, thereby driving the insertion element 11 on the ablation body 2 to drill into or unscrew out of the target tissue.

[0082] In one embodiment of the present invention, the screw-in member 11 is made of an insulating material, or is made of a metallic material but its outer surface is made of an insulating material. In this embodiment, the screw-in member 11 only serves to screw in and fix the electrode. In another embodiment of the present invention, the screw-in member 11 is a spiral electrode head made of a conductive material, including but not limited to platinum-iridium alloy, gold, nickel-cobalt-chromium-molybdenum alloy, stainless steel, titanium alloy, and other metals. The screw-in member not only serves to screw in and fix the electrode but also has functions such as ablation, mapping, and pacing. When the screw-in member 11 is made of a conductive material, it can be connected to the ablation electrode 21 and serve as part of the ablation electrode 21, or it can be insulated from the ablation electrode 21 and connected to both the screw-in member 11 and the ablation electrode 21 by separate wires. The screw-in member 11 and the ablation electrode 21 have opposite or the same polarity.

[0083] The screw-in member 11 is fixed on the ablation electrode 21. When the ablation electrode 21 of the present invention has a third cavity 214 at its first end (e.g.) Figure 6As shown, the screw-in member 11 is connected within the third cavity 214. In one embodiment of the invention, the screw-in member 11 is fixedly connected within the third cavity 214, and the length of the screw-in member 11 is greater than the axial length of the third cavity 214, so that the tip of the screw-in member 11 protrudes outside the third cavity 214, thereby facilitating screwing into the target tissue. Furthermore, the screw-in member 11 can also be retractably connected within the third cavity 214, and the length of the screw-in member 11 is less than or equal to the axial length of the third cavity 214. That is, during the process of not using and / or entering the human body with the ablation catheter 10, the screw-in member 11 is housed within the ablation body 2; when reaching the vicinity of the target tissue, the screw-in member 11 extends out of the ablation body 2. This arrangement can reduce accidental injury to other tissues by the tip of the ablation catheter 10 during the procedure. Methods commonly used in the art can be used to retractably connect the screw-in member 11 within the third cavity 214, for example, by using an electromagnetic spring, a motor, and a screw / gear to extend or retract the screw-in member 11 into the third cavity 214.

[0084] Furthermore, such as Figure 4-5 As shown, the insertion portion 1 also includes an insert 12, configured to insert into target tissue and / or ablate the tissue portion screwed into by the screw-in member 11. The screw-in member 11 is sleeved on the outer periphery of the insert 12 and does not contact the insert 12. In one embodiment of the invention, the length of the screw-in member 11 is greater than the length of the insert 12, such that when the screw-in member 11 is not screwed in, the insert 12 is surrounded within the screw-in member 11, and the insert 12 will not puncture human tissue. Similar to the screw-in member 11, the insert 12 can be either insulating or conductive. When the insert 12 is conductive, it can be connected to the ablation electrode 21, serve as part of the ablation electrode 21, or be insulated from the ablation electrode 21 and connected to the insert 12 and the ablation electrode 21 respectively by separately provided wires.

[0085] In one embodiment of the present invention, the insert 12 is a hollow structure and has a through hole 121 penetrating the circumferential surface of the insert 12. Figure 5 The proximal end of the insert 12 is connected to the second cavity 212 via a channel 215, allowing liquid to flow out of the insert 12 through the through hole 121 via the second cavity 212. In another embodiment of the invention, the insert 12 is retractable, meaning that when not in use and / or during the insertion of the ablation catheter 10 into the human body, the insert 12 is housed within the ablation body 2; when reaching the vicinity of the target tissue, the insert 12 extends out of the ablation body 2. This arrangement reduces the risk of accidental injury to other tissues by the tip of the ablation catheter 10 during the procedure. Similar to the screw-in insert 11, the retraction control of the insert 12 can be achieved using methods commonly used in the art.

[0086] refer to Figure 6The distal end of the ablation electrode 21 has a first end connected to the screw-in member 11. In this embodiment, the first end has a third cavity 214 extending towards the second cavity 212, and the screw-in member 11 is fixed within the third cavity 214. However, as long as the first end of the ablation electrode 21 can fix the screw-in member 11, its structure is not particularly limited. For example, the first end can be a solid structure, a portion of the screw-in member 11 can be embedded in the first end to fix it, or the screw-in member 11 can be integrally formed with the first end. The screw-in member 11 and the ablation electrode 21 can be connected according to the actual application using methods known in the art. For example, they can be fixedly connected by bonding, riveting, pressing, welding, etc., or they can be detachably connected by snap-fitting, threaded connection, etc.

[0087] A first cavity 211 is provided at the proximal end of the ablation electrode 21, opposite to the first end, and a connector 22 (such as...) is provided inside the first cavity 211. Figure 8 (As shown). The second cavity 212, the infusion port 213, and the first channel 223 in the connector 22 are connected to the infusion channel 32 in the catheter body 3 (as shown). Figure 11 (As shown) The saline solution and other liquids delivered by the infusion channel 32 are transported to the second cavity 212 through the first channel 223, and then infused into the ablation electrode 21 and the target tissue through the infusion hole 213 to reduce the temperature of the ablation electrode 21 and the target tissue.

[0088] The ablation electrode 21 can be made of any material commonly used in electrode manufacturing in the art, without particular limitation, such as gold, copper, titanium alloy, platinum, stainless steel, etc. In one embodiment, the ablation electrode 21 is coated with an anti-arc adhesive to reduce the generation of an electric arc during ablation and improve safety.

[0089] In other embodiments of the present invention, the ablation body 2 includes an insulating shell and at least two ablation electrodes spaced apart along the axial direction of the insulating shell. In this embodiment, the structure of the insulating shell can be the same as the structure of the ablation electrode 21 described above, and will not be repeated here, the only difference being that it is non-conductive. The at least two ablation electrodes can be ring electrodes sleeved on the insulating shell, each connected to a control handle via wires. Several injection holes are formed on the circumferential surface of the ring electrodes. A reasonable electrode spacing and ablation parameters are set between the at least two ablation electrodes, so that a continuous ablation area can be formed after ablation. In a preferred embodiment, the polarities of the two ablation electrodes are opposite; in a preferred embodiment, the spacing between the two ablation electrodes is 1-6 mm; in a preferred embodiment, the voltage applied to each ablation electrode is 800-3600 V.

[0090] In this invention, the ablation electrode 21 can not only be used to ablate target tissue, but also to determine the position of the ablation catheter 10 before ablation begins. Because blood and muscle have different conductivity, and the conductivity also varies at different locations within the same muscle tissue, the impedance of the ablation electrode 21 also varies at different locations (by forming a circuit with a negative electrode plate on the body surface), such as... Figure 15 As shown, when the ablation electrode 21 is only in contact with the blood and has not entered the interventricular septum (Figure I), its impedance is relatively low. However, when the ablation electrode 21 enters the interventricular septum (Figure II) and reaches the center of the interventricular septum (Figure III), its impedance gradually increases, reaching its maximum at the center of the interventricular septum (Figure III). As the ablation electrode 21 continues to penetrate deeper from the center of the interventricular septum away from its entry point (Figure IV-V), its impedance gradually decreases again. Therefore, the location can be easily identified by observing the impedance change of the ablation electrode 21 as the ablation catheter 10 moves within the body.

[0091] Furthermore, the ablation electrode 21 can be used in conjunction with the non-ablation electrode 31 to emit electrical stimulation / pacing signals. The location of the ablation electrode 21 can be determined by whether these signals are detectable on the body surface and by the differences in the signals. In short, during the insertion of the ablation catheter 10, the ablation electrode 21 continuously emits electrical stimulation / pacing signals. When the ablation electrode 21 is not inserted into the target tissue, the emitted electrical signals will not be transmitted to the body surface and detected. However, after contact with the target tissue, the signals will be transmitted to the body surface and detected, resulting in changes on the electrocardiogram (ECG). Moreover, the emitted electrical signals will differ when the target tissue is the left and right ends of the interventricular septum. Specifically, due to the presence of the left and right bundle branches within the interventricular septum, the distance between the left and right bundle branches and the signal source will change on the ECG when they receive the electrical signals and feed them back. These changes in the ECG can be used to determine the insertion distance. Figure 21 As shown in Figure A, the electrocardiograms in lead V1 are as follows when the ablation electrode 21 is located in different positions (1-5). Figure 21 As shown in B, where I represents the right ventricle, II represents the interventricular septum, and III represents the left ventricle.

[0092] Furthermore, after emitting ablation energy, the ablation electrode 21 can also, in conjunction with the non-ablation electrode 31, emit electrical stimulation / pacing signals to determine the extent of damage to the target tissue. Specifically, the patient's own electrocardiogram, such as... Figure 16 As shown in Figure a of C, according to the basic principle of ablation, after the ablation of the target tissue is completed, the cells of the target tissue either undergo necrosis during radiofrequency ablation or apoptosis after irreversible electroporation during pulsed ablation. Regardless of the type of ablation, within the damage range of the target tissue, voltages below a certain value cannot be transmitted through the ablation site to undamaged tissues. The electrocardiogram at this time is as follows: Figure 16Figure c in section C shows an ECG of non-captured after ablation. By applying gradually increasing voltage electrical signals (electrical stimulation / pacing signals) to the ablated tissue, mimicking pacing function, stimulation is applied to the target tissue. The size of the effective ablation area can be determined by whether a captured ECG can be detected on the body surface at different voltage values. When the applied pacing voltage signal is greater than or equal to the pacing voltage threshold, a captured ECG can be detected on the body surface (e.g., ...). Figure 16 (As shown in Figure b in C), the completed ablation damage area is the expected ablation damage area corresponding to the pacing voltage threshold. The pacing voltage threshold is the lowest voltage that can be transmitted from the ablated tissue to the unablated tissue after the expected ablation damage area has been completed. For example, assuming the ablation area is 10mm (distance from the ablation catheter), the corresponding pacing voltage threshold is 5V. When the applied voltage is less than 5V, the target tissue will not react, and the signal cannot be detected externally. However, when it exceeds 5V, it can be detected, thus determining the ablation area. The pacing voltage threshold is directly proportional to the expected ablation damage area, such as... Figure 16 As shown in A and B, if the ablation damage area X is smaller than the ablation damage area Y, then the pacing voltage threshold corresponding to the ablation damage area X is smaller than the pacing damage voltage corresponding to the ablation damage area Y.

[0093] The infusion port 213 of this invention is located on the circumferential surface of the ablation electrode 21, enabling direct infusion of liquid into the target tissue. The liquid circulation is external circulation, which provides a superior cooling effect compared to circulation only within the ablation catheter 10. This is because, firstly, the liquid cools both the ablation electrode 21 and the target tissue simultaneously, accelerating the cooling efficiency; secondly, internal circulation has a lower cooling effect on the ablation electrode 21 at the same flow rate than external circulation. Furthermore, the second cavity 212 in this invention buffers the incoming liquid, reducing the pressure of the liquid flowing out of the infusion port 213 and preventing tissue damage due to excessive pressure.

[0094] In one embodiment of the present invention, the injection hole 213 is disposed on the side of the second cavity 212 near the first cavity 211, thereby enabling the second cavity 212 to function as a water storage tank and reducing the pressure at the injection hole 213. Figure 7As shown, in a preferred embodiment, the infusion holes 213 are arranged in multiple groups, and the multiple groups of infusion holes 213 are distributed at intervals along the axial direction of the ablation electrode 21 on the outer peripheral surface of the second cavity 212. In a preferred embodiment, each group of infusion holes 213 includes multiple infusion sub-holes, which are distributed at intervals along the circumferential direction of the ablation electrode 21 (7B). In another preferred embodiment, the projection portions of two adjacent infusion holes 213 on a plane perpendicular to the axial direction of the ablation electrode 21 coincide (7A). This arrangement allows for more uniform dispersion of the liquid, a larger contact area with the ablation electrode 21 and the target tissue, and better cooling efficiency. The shape of the infusion holes 213 is not particularly limited and can be selected from one or more of the following: circular, elliptical, arc-shaped, fan-shaped, arc-shaped, and polygonal.

[0095] The following is combined Figure 8-11 Explain the structure of connector 22 and the connection between ablation body 2 and catheter body 3. Figure 8 This is a schematic cross-sectional view of connector 22 along a plane parallel to the X-axis. Figure 9 This is a schematic diagram showing the connection between connector 22 and ablation electrode 21. Figure 10 This is a schematic cross-sectional view of the connector 22 and the ablation electrode 21 along a plane perpendicular to the X-axis after connection. Figure 11 This is a schematic cross-sectional view of the connected ablation body 2 and catheter body 3 along a plane parallel to the X-axis. As shown, the connector 22 includes a first connecting portion 221 connected to the ablation electrode 21, a second connecting portion 222 connected to the catheter body 3, a first channel 223 axially penetrating the connector 22, and a second channel 224 formed by the inner wall of the first cavity 211 of the connector 22 and the ablation electrode 21. The first connecting portion 221 is disposed within the first cavity 211, and the proximal end of the second connecting portion 222 extends out from the ablation electrode 21 and connects to the catheter body 3. In one embodiment of the invention, as... Figure 9 and 11As shown, the outer diameter of the first connecting portion 221 of the connector 22 is slightly smaller than the inner diameter of the first cavity 211 so that the first connecting portion 221 can enter the first cavity 211. The portion of the first cavity 211 near the second cavity 212 has a flange 2111, and the first connecting portion 221 of the connector 22 abuts against the flange 2111. The second connecting portion 222 is a limiting protrusion structure. The catheter body 3 has a limiting recess 35 on the side near the ablation body 2 that is adapted to the second connecting portion 222. The connector is fixed to the catheter body 3 by extending the second connecting portion 222 into the limiting recess 35. The connector 22 can be fixedly connected to the ablation body 2 and the catheter body 3 by means of bonding, riveting, pressing, welding, etc., and can also be detachably connected by means of snap-fit, threaded connection, etc. The second channel 224 is used to configure other components, such as the temperature sensor 23 and the wire 24 connected to the ablation electrode 21. Furthermore, depending on actual needs, those skilled in the art can increase the number of second channels 224 and arrange different components in different second channels 224, such as positioning sensors, electrical wires connected to the screw-in member 11, and electrical wires connected to the insert member 12. The second channels 224 are not connected to the second cavity 212; therefore, liquid will not enter the second channels 224, thereby reducing interference from liquid on the components arranged in the second channels 224. Furthermore, separating different components also reduces interference between them. The connector 22 is insulated, made of insulating material, or at least its surface is made of insulating material.

[0096] Furthermore, in some embodiments of the present invention, the ablation body 2 also includes a positioning sensor located in a second channel 224. The positioning sensor can be positioned using electric field, magnetic field, electromagnetic field, etc. In one embodiment of the present invention, the ablation catheter 10 uses a magnetoelectric positioning method with a positioning sensor to determine the position of the ablation electrode 21. Specifically, a magnetic field generator is placed under the surgical area / bed to construct an overall magnetic field, and a positioning sensor with a magnetic coil is placed in the catheter. The position of the catheter is determined by monitoring changes in the magnetic field. In one embodiment, the positioning sensor of the present invention does not sense its positional relationship with the target tissue. When two ablation catheters 10 of the present invention are used simultaneously for ablation, the positioning sensors located on the two ablation catheters 10 sense the position between them. Ablation is performed when the distance between them reaches a set distance threshold, ensuring the ablation effect and achieving complete ablation of the entire hypertrophic ventricular septum. The aforementioned distance threshold refers to the maximum distance between the two ablation catheters 10 that allows at least partial overlap between A and B when the ablation damage areas of the two ablation catheters 10 are A and B, respectively. The ablation damage range is related to the ablation energy released by the ablation electrode 21. Those skilled in the art can adjust the ablation parameters as needed to obtain the desired ablation damage range. For example, when the ablation energy is a pulse, the pulse width, inter-pulse delay, pulse voltage, etc., can be adjusted. In one embodiment, the two positioning sensors use microwave positioning to sense the distance between them.

[0097] like Figure 1 and 2 As shown, in some embodiments, the catheter body 3 includes a non-ablative electrode 31. The non-ablative electrode 31 can be made of any material commonly used in electrode manufacturing in the art, without particular limitation, such as gold, copper, titanium alloy, platinum, stainless steel, etc. In one embodiment of the invention, the non-ablative electrode 31 has a ring-shaped structure with a length of 0.5-5 mm. An electrical wire is provided in the catheter body 3 to connect it to the control handle 4, achieving electrical connection.

[0098] The non-ablation electrode 31 is not used to emit ablation energy, but rather to detect signal differences (such as impedance differences) with the ablation electrode 21 during the ablation process to determine the position of the ablation electrode 21, to apply pacing voltage signals in conjunction with the ablation electrode 21, and to detect electrocardiogram signals to determine the position of the ablation electrode 21 and the extent of ablation damage. The non-ablation electrode 31 is spaced 2-30 mm from the ablation electrode 21. Figure 1 and 2The spacing D in the middle allows for easier acquisition of suitable signal differences without affecting the ablation effect. When determining the location, similar to using the ablation electrode 21 alone for distance determination, the impedance of the spaced-apart ablation electrode 21 and the non-ablation electrode 31 will differ depending on the medium, due to the different conductivities of blood and muscle, and even different regions of the same tissue. This impedance difference changes as the ablation catheter 10 moves near the target tissue. Therefore, the location of the ablation electrode 21 can be determined before ablation based on the impedance difference. Specifically, when entering the left and right ventricles but not yet penetrating the interventricular septum, both the ablation electrode 21 and the non-ablation electrode 31 are in contact with the intraventricular blood, and their detected impedances are relatively close or almost identical. However, as the insertion part 1 extends further, the ablation electrode 21 gradually contacts the target tissue (hypertrophic myocardium of the interventricular septum), while the spaced-apart non-ablation electrode 31 remains in contact with the blood, resulting in an impedance difference between the two. Furthermore, as the ablation electrode 21 penetrates deeper (from partial contact to complete insertion into the interventricular septum), the impedance difference increases. Therefore, the degree of insertion can be determined by observing the change in impedance. Using a combination of ablation electrode 21 and non-ablation electrode 31 to determine location via impedance difference yields a larger and more accurate result compared to using ablation electrode 21 alone. Multiple non-ablation electrodes 31 can be used, and the spacing between them can be arbitrarily set.

[0099] Regarding the components in the ablation catheter 10 of the present invention, such as the ablation electrode 21, the non-ablation electrode 31, the temperature sensor 23, and the positioning sensor, which require electrical conductivity, those skilled in the art should know that appropriate wires can be set to connect them respectively to achieve signal / electrical connection with the control handle 4.

[0100] In some embodiments, the catheter body 3 includes an infusion channel 32, an elastic tube 33, and an outer tube 34, with the elastic tube 33 sleeved on the inner circumferential surface of the outer tube 34. Specifically, as shown... Figure 11 As shown, the elastic tube 33 is formed by multiple threads coiled around the inner circumference of the outer tube 34. The threads can be made of metallic materials or non-metallic materials with good elasticity. Since the ablation electrode 21 needs to be screwed into the target tissue for ablation, adding the elastic tube 33 improves both the overall support of the ablation catheter 10 and its resistance to bending during torsion. The hollow elastic tube 33 forms a fluid infusion channel 32, which communicates with the ablation electrode 21 to deliver fluid to the ablation electrode 21.

[0101] In some embodiments, the catheter body 3 also includes an adjustable bend located on the side of the catheter body 3 close to the ablation body 2. The angle of the distal end of the catheter body 3 can be changed by the adjustable bend, thereby changing the position and angle of the insertion part 1 and the ablation body 2, which facilitates surgical manipulation.

[0102] During ablation surgery, the liner enters the ablation catheter 10 from its proximal end, providing guidance and support. However, due to the small diameter of the liner, the corresponding liner channel within the ablation catheter 10 also has a small diameter. Therefore, when inserting the liner into the liner channel, it is often difficult to align the liner with the entrance of the channel, resulting in difficulty in inserting the liner. Therefore, in some embodiments, the ablation catheter 10 of the present invention further includes a guide 6 for guiding the liner into the ablation catheter 10. Figure 12-13 As shown, the guide 6 includes a connecting portion 61, a gripping portion 62, a guiding portion 63, and a guiding hole 64 passing through the connecting portion 61, the gripping portion 62, and the guiding portion 63, arranged sequentially from the distal end to the proximal end. The connecting portion 61 is used to connect the guide 6 to the ablation catheter 10. In a preferred embodiment, the connecting portion 61 is threaded to the ablation catheter 10, and includes a threaded structure 611 corresponding to the threaded structure on the ablation catheter 10 and a boss 612, which can extend into a groove corresponding to the ablation catheter 10. In addition, the connecting portion 61 can also be connected to the ablation catheter 10 using other methods known in the art, such as snap-fitting or welding. The gripping portion 62 is located between the connecting portion 61 and the guiding portion 63, facilitating user operation and gripping. In some embodiments, the guide 6 may not include the gripping portion 62, and the guide 6 is gripped by the connecting portion 61 and / or the guiding portion 63 during use. The inner wall of the guide portion 63 is shaped like a flared mouth, with its diameter gradually decreasing from the end furthest from the connecting portion 61 to the end closest to the connecting portion 61. The opening of the guide portion 63 near the user is larger, facilitating the insertion of a smaller diameter liner wire. Because its opening diameter gradually decreases, even if the liner wire does not initially enter the guide hole 64 directly, it can slide into the guide hole 64 under the action of the tapered inner wall of the guide portion 63, simplifying the operation and saving time. The guide hole 64 axially penetrates the guide member 6 and communicates with the liner wire channel in the ablation catheter 10, allowing the liner wire entering the guide member 6 to directly enter the ablation catheter 10. In one embodiment of the invention, the liner wire channel and the infusion channel 32 are the same channel.

[0103] In one embodiment of the present invention, such as Figure 14As shown, the ablation catheter 10 includes a three-way valve 5 connected to a control handle 4. One opening of the three-way valve 5 can communicate with an infusion device. A guide 6 is connected to the other opening of the three-way valve 5, and the other end of the guide 6 is connected to a torque transmitter 7. A liner wire is fixed in the central hole of the torque transmitter 7. Because the liner wire is thin, it is difficult for the user to pinch and manipulate it. The torque transmitter 7 is provided so that the liner wire can be manipulated by operating the torque transmitter 7, transmitting the torque generated by the torsion at the proximal end to the distal end.

[0104] Figure 17 This is a schematic diagram of an ablation system according to the present invention, as shown below. Figure 17-18 As shown, the ablation system of the present invention includes an integrated ablation device and an ablation catheter 10, a perfusion device, and an imaging system, all connected to the integrated ablation device. The perfusion system is also connected to the ablation catheter 10 to provide fluid to the ablation catheter 10 under the control of the integrated ablation device. In some embodiments, the perfusion fluid is physiological saline. In other embodiments, the perfusion device can be controlled by the integrated ablation device to perfuse other fluids into the ablation catheter 10, as long as it achieves the effect of improving the conductivity and thermal conductivity of the ablated tissue, maintaining impedance balance, keeping the impedance in a relatively stable state, reducing the temperature of the ablated tissue, and increasing the humidity of the ablated tissue, fundamentally avoiding the formation of scabs due to drying and heating of the ablated tissue, and without causing serious side effects to the human body. The perfusion rate of the perfusion device is adjustable, and the rate can be controlled in real time by the integrated ablation device during perfusion. The output capacity should be at least 0.05-10.0 mL / min. The imaging device is used to display the image of the ablation catheter 10 in the human body during the operation. The imaging device can be a combination of one or more systems such as a three-dimensional imaging system, CT, MR, and DSA. In this invention, to reduce surgical requirements, lower hospital costs, and expand the application scope of the ventricular septal ablation system, only a DSA (Digital Subtraction Angiography) device is needed to meet the minimum surgical imaging requirements. This eliminates the need for a complete and expensive full-system imaging system, allowing even non-tertiary township hospitals to meet the surgical conditions, thus expanding the scope of beneficiaries and facilitating widespread adoption. Furthermore, compared to CT, DSA reduces the radiation dose to the surgeon, improving surgeon safety. When performing pulsed ablation, a negative electrode plate 20 needs to be placed outside the patient's body.

[0105] The integrated ablation device includes an ablation generation module, a temperature detection module, an impedance detection module, an ECG signal detection module, an electrical stimulation / pacing signal module, an MCU central control module, an interactive control module, and an ablation control switch. The ablation generation module generates and transmits ablation energy to the ablation electrode 21. This ablation energy can be radio frequency energy or pulsed energy. In a preferred embodiment, the ablation generation module can also emit one or more of the following: cryogenic energy, laser, chemical, electroporation, high-intensity focused ultrasound or ultrasound, and microwave. The temperature detection module receives signals from the temperature sensor 23 of the ablation catheter 10 and feeds them back to the MCU central control module. The impedance detection module detects the impedance of the ablation electrode 21 and / or the non-ablation electrode 31 and feeds it back to the MCU central control module. The ECG signal detection module detects electrocardiogram signals and feeds them back to the MCU central control module. The electrical stimulation / pacing signal module generates and transmits electrical stimulation / pacing signals through the ablation electrode 21 under the control of the MCU central control module. The MCU central control module is connected to the ablation generation module, temperature detection module, impedance detection module, ECG signal detection module, electrical stimulation / pacing signal module, interactive control module, ablation control switch, ablation catheter 10, perfusion equipment, and imaging equipment. It receives and processes information from other modules and provides feedback and / or displays the processed information. For example, after receiving temperature feedback from the temperature detection module, the MCU central control module controls the perfusion equipment to change the perfusion rate based on a predefined threshold temperature. The perfusion rate increases when the temperature exceeds the threshold temperature and decreases when the temperature falls below it. Preferably, the predefined threshold temperature is typically 40-70 degrees Celsius, and more preferably 55 degrees Celsius. Except in the stopped state, during perfusion, a minimum flow rate threshold is required, preferably 0.5 mL / min. The interactive control module is used to display information and accept user control commands. In one embodiment, the interactive control module can be a touch screen. The ablation control switch is used to control the application of ablation energy to the target tissue. In one embodiment, the ablation control switch is a foot switch, which starts the ablation function when the user presses the pedal. Simultaneously, a certain time can be customized, such as continuous foot pressing within 3 seconds, to control different ablation functions / modes. In one embodiment of the invention, the ablation system further includes a position detection module. When the ablation catheter 10 includes a positioning sensor, the position detection module receives the signal from the positioning sensor and feeds it back to the MCU central control module.

[0106] When performing ablation using the above-mentioned ablation system, the following steps shall be followed: S1: Subclavian vein / jugular vein puncture, and ablation catheter 10 shall be inserted into the right ventricle through a delivery catheter; S2: Under the guidance of the imaging equipment, adjust the angle and position of the delivery catheter and ablation catheter 10, and monitor the impedance and / or electrocardiogram waveform in real time. The impedance is the impedance between the ablation electrode 21 and the negative electrode plate 20 on the patient's body surface and / or the impedance difference between the ablation electrode 21 and the non-ablation electrode 31; S3: After the delivery catheter reaches the designated position, screw the insertion part 1 into the eye. During the target ablation process, the insertion part 1 is screwed in and the depth of screwing in is determined based on the impedance change between the ablation electrode 21 and the negative electrode plate 20 on the patient's body surface and / or the impedance difference change between the ablation electrode 21 and the non-ablation electrode 31. After the ablation electrode 21 reaches the target ablation area, the perfusion device is turned on; S4: Adjust the parameters and perform ablation; S5: After ablation is completed, perform electrical stimulation to check whether the ablation is sufficient; S6: Screw out; S7: If other points need to be ablated, repeat S2-S6; S8: After all procedures are completed, remove the catheter from the body.

[0107] In a preferred embodiment of the present invention, the ablation catheter 10 includes a positioning sensor, and step S2 further includes using the positioning sensor to determine the position of the ablation electrode 21 by magnetoelectric positioning of the ablation catheter 10. In one embodiment, unlike the above-described subclavian vein / jugular vein puncture, in which the ablation catheter 10 is inserted into the right ventricle via a delivery catheter, alternatively, in step S1, the femoral artery is punctured, and the ablation catheter 10 is inserted into the left ventricle via a delivery catheter. In one embodiment, step S3 may also involve emitting an electrical signal through the ablation electrode 21, and determining whether the insertion portion 1 is screwed in and the depth of screwing in based on whether the electrical signal can be detected on the body surface and the changes in the electrical signal. In one embodiment, in step S5, the electrical stimulation test involves applying a gradually increasing pacing voltage signal to the ablated tissue through the ablation electrode 21. When the applied pacing voltage signal is greater than or equal to the pacing voltage threshold, an electrocardiogram after the electrical signal capture can be detected on the body surface. The completed ablation damage area is the expected ablation area corresponding to the pacing voltage threshold. The pacing voltage threshold is the lowest voltage that can be transmitted through the ablated tissue to the unablated tissue after the expected ablation damage area is completed. The pacing voltage threshold is proportional to the expected ablation damage area.

[0108] In one embodiment, the insertion portion 1 is electrically insulated, and the ablation electrode 21 emits radiofrequency energy to the target tissue, causing thermal damage to the cells and thus achieving ablation. In another embodiment, the insertion portion 1 is electrically insulated, and the ablation electrode 21 emits pulsed energy to the target tissue. A negative electrode plate 20 is provided on the body surface, causing irreversible electroperforation of the cells in the target tissue, thereby achieving ablation. In another embodiment, the insertion portion 1 is conductive and has the opposite polarity to the ablation electrode 21. The ablation electrode 21 emits pulsed energy to the target tissue. In this case, the ablation catheter 10 functions as a pulsed bipolar ablation catheter, causing irreversible electroperforation of the cells in the target tissue, thereby achieving ablation. In yet another embodiment, the insertion portion 1 is electrically insulated, and the ablation body includes at least two ablation electrodes 21 with opposite polarities. The ablation electrodes 21 emit pulsed energy to the target tissue. In this case, the ablation catheter 10 functions as a pulsed bipolar ablation catheter, causing irreversible electroperforation of the cells in the target tissue, thereby achieving ablation.

[0109] Figure 19 A schematic diagram of another ablation system of the present invention is shown, and... Figure 17 Compared to the single ablation catheter ablation system shown, the difference in this embodiment is that the ablation system includes two ablation catheters 10, which are respectively connected to the integrated ablation device and the perfusion equipment. Other components are... Figure 17 The ablation system shown is the same. Figure 20 This illustrates the ablation process using a single ablation catheter in the left ventricle (A) and right ventricle (B). When performing ablation using the ablation system of this embodiment, subclavian / jugular vein puncture is performed, and one ablation catheter 10 is advanced into the right ventricle via a delivery catheter, then rotated into the interventricular septum. The other ablation catheter 10 is then advanced into the left ventricle via a delivery catheter through femoral artery puncture, and rotated into the interventricular septum. Other steps are the same as described above. Figure 17 The operating steps for the single ablation catheter ablation system shown are the same.

[0110] Depending on actual usage needs, the ablation system of the present invention may also include more than two ablation catheters 10, with each ablation catheter 10 connected to the integrated ablation device and the infusion equipment respectively. The connection methods and operation methods of other components are the same as those for other applications. Figure 17 and 19 The ablation system shown is the same, and those skilled in the art can operate more than two ablation catheters 10 according to the above description of the present invention.

[0111] Furthermore, regarding the polarity of the ablation electrode 21 and whether the insertion portion 1 is conductive, Figure 19The ablation system shown can also be configured as follows: the insertion portions 1 of the two ablation catheters 10 are electrically insulated, the two ablation electrodes 21 have the same / different polarities but are not related to each other, emit pulse energy, and a negative electrode plate 20 is attached to the outside of the body, with each ablation electrode 21 performing single-stage ablation; or the insertion portions 1 of the two ablation catheters 10 are electrically insulated, the two ablation electrodes 21 have opposite polarities, emit pulse energy, and work together during ablation to achieve bipolar ablation, which can effectively increase the ablation area.

[0112] Although the medical diagnosis of hypertrophic cardiomyopathy is an interventricular septum thickness greater than 15 mm, in practice, patients often have a thickness exceeding 20 mm, with some reaching as high as 30 mm. Patients with this thickness require deeper insertion. However, on the one hand, after insertion, torque transmission is hindered by myocardial tissue, making deeper insertion increasingly difficult. On the other hand, the ablation area is limited; excessive depth means incomplete ablation may be impossible. Therefore, by simultaneously inserting at least two ablation catheters10 into the left / right ventricle for ablation, the ablation area can be effectively expanded, and the difficulty of insertion can be reduced.

[0113] In addition, while pulse ablation is safer than radiofrequency ablation, it also limits the size of the ablation area. If the ablation area is to be increased without changing the equipment, the pulse width / voltage needs to be increased. However, if these increases exceed the threshold, they may cause physiological reactions in patients, such as muscle tremors. Figure 19 The ablation system shown has at least two ablation catheters 10, which allows for simultaneous ablation of the hypertrophic ventricular septum in hypertrophic cardiomyopathy from both sides. This enables better ablation results without increasing pulse width / voltage, and improves safety while ensuring ablation efficacy.

[0114] In a preferred embodiment of the present invention, at least one of the two ablation catheters 10 includes a positioning sensor. The positioning sensor is configured to use magnetoelectric positioning to determine the position of the ablation catheter 10 containing the positioning sensor and transmit the position signal to the integrated ablation device. Furthermore, in a preferred embodiment, each of the two ablation catheters 10 includes a positioning sensor. The two positioning sensors are configured to use microwave positioning to sense the distance between them and transmit the distance signal to the integrated ablation device. The advantage of this approach is that, compared to the coarse judgment of insertion distance and position based on impedance and electrocardiogram waveforms, the position signal transmitted by the positioning sensor, especially the distance judgment between the two positioning sensors, is more accurate and easier to implement, and can be achieved without any other expensive equipment. Currently, determining the position of ablation catheters requires hospitals to have a three-dimensional mapping system, which costs several million yuan, an expensive price that is difficult for ordinary basic hospitals to afford, thus restricting the development of ablation surgery. With easily implemented positioning sensors, insertion and position determination can be completed under the guidance of the simplest imaging equipment, significantly reducing the basic conditions for performing the surgery and reducing the learning difficulty for doctors.

[0115] In summary, this invention provides an ablation catheter and an ablation system including the ablation catheter. The catheter is fixed within the target tissue via its insertion portion, facilitating precise fixation of the ablation position, preventing changes during operation. Furthermore, the inclusion of non-ablation electrodes allows for the detection of impedance, pacing voltage, etc., facilitating the monitoring of the ablation catheter's position and insertion depth without requiring expensive 3D imaging equipment. Moreover, when using the ablation system comprising at least two ablation catheters, this invention enables bipolar ablation, which is more effective. The bidirectional insertion of the two ablation catheters avoids excessive insertion of a single catheter, reducing tissue damage, expanding the ablation range, and enabling cost-effective and accurate detection of the ablation catheter's position using positioning sensors.

[0116] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings. However, the present invention is not limited to the above embodiments. The components of the present invention can be used in any combination. Within the knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention.

Claims

1. An ablation catheter, characterized in that, It includes an insertion part, an ablation body, a catheter body, a control handle, and a guide connected in sequence; in, The insertion part includes a screw-in member, which can be rotated and drilled into and fixed into the target tissue under the action of external force. The screw-in member is in the shape of a three-dimensional spiral or a screw, and the end away from the ablation body is a pointed tip. The ablation body includes an ablation electrode, a connector, and a temperature sensor. The ablation electrode has a first end connected to the screw-in member, a first cavity disposed opposite to the first end, a second cavity extending from the first cavity toward the first end, and an infusion hole penetrating the circumferential surface of the ablation electrode. The connector is disposed in the first cavity. One end of the connector near the catheter body extends out of the first cavity and is connected to the catheter body. The connector has an axially penetrating first channel. The first channel communicates with the second cavity, the infusion hole, and the infusion channel in the catheter body. The connector and the inner wall of the first cavity form a plurality of second channels. The temperature sensor is located in one of the second channels. The catheter body includes a non-ablation electrode and the infusion channel. The non-ablation electrode is spaced apart from the ablation electrode. During ablation, the non-ablation electrode does not come into contact with the target tissue. The guide includes a connecting portion, a guiding portion, and a guide hole penetrating the connecting portion and the guiding portion. The connecting portion is connected to the proximal end of the ablation catheter. The inner wall of the guiding portion is shaped like a funnel, with the diameter gradually decreasing from the end away from the connecting portion to the end near the connecting portion. The guide hole communicates with the lining wire channel in the ablation catheter to guide the lining wire through the guide hole and the lining wire channel into the ablation catheter. The lining wire is used to support the ablation catheter. The lining wire channel and the infusion channel are the same channel.

2. The ablation catheter according to claim 1, characterized in that, The position information of the ablation electrode is provided by the impedance difference between the ablation electrode and the non-ablation electrode.

3. The ablation catheter according to claim 2, characterized in that, The impedance of the ablation electrode and the non-ablation electrode in the blood is approximately the same. The difference between the impedance of the ablation electrode and the impedance of the non-ablation electrode is determined based on the difference in conductivity between blood and muscle tissue. Furthermore, the impedance change of the ablation electrode is determined based on the difference in conductivity at different locations within the same muscle tissue, so as to obtain the difference between the impedance of the ablation electrode and the impedance of the non-ablation electrode at different locations.

4. The ablation catheter according to claim 1, characterized in that, The pitch of the screw-in part gradually decreases from the far end to the near end, and the pitch of the screw-in part is 0.25-1.5 times the diameter of the screw-in part.

5. The ablation catheter according to claim 1, characterized in that, The diameter of the screw-in part gradually decreases from the proximal end to the distal end.

6. The ablation catheter according to claim 1, characterized in that, The first end of the ablation electrode has a third cavity, and the screw-in member is telescopically connected to the third cavity, and the length of the screw-in member is less than or equal to the axial length of the third cavity.

7. The ablation catheter according to claim 1, characterized in that, When the screw-in part is in the shape of a three-dimensional helix, the extension part further includes an insert, the length of which is less than or equal to the length of the screw-in part, the insert is fitted inside the screw-in part and does not contact the screw-in part.

8. The ablation catheter according to claim 7, characterized in that, The insert is a hollow structure and has a through hole that penetrates the circumferential surface of the insert. The proximal end of the insert is connected to the second cavity.

9. The ablation catheter according to claim 1, characterized in that, The infusion holes are configured in multiple groups, and the multiple groups of infusion holes are distributed at intervals along the axial direction of the ablation electrode on the outer peripheral surface of the second cavity. The projection portions of two adjacent infusion holes on a plane perpendicular to the axial direction of the ablation electrode overlap.

10. The ablation catheter according to claim 1, characterized in that, The ablation body also includes a positioning sensor configured to sense the position of the ablation catheter in the target tissue, and the temperature sensor and the positioning sensor are located in different second channels.

11. The ablation catheter according to claim 1, characterized in that, The guide also includes a gripping portion located between the connecting portion and the guide portion, and the guide hole extends through the connecting portion, the gripping portion, and the guide portion.

12. The ablation catheter according to claim 1, characterized in that, The injection hole is located on the side of the second cavity near the first cavity.

13. The ablation catheter according to claim 1, characterized in that, The ablation catheter also includes a torque transmitter connected to the guide. The liner is fixed in the central hole of the torque transmitter. By operating the torque transmitter, the liner is operated to transmit the torque generated by the torsion of the proximal end of the liner to the distal end of the liner.

14. The ablation catheter according to claim 13, characterized in that, The ablation catheter also includes a three-way valve, which is connected to the control handle. One opening of the three-way valve is used to communicate with the infusion device. One end of the guide is connected to the other opening of the three-way valve, and the other end of the guide is connected to the torque transmission element.

15. An ablation system, characterized in that, The invention comprises an ablation catheter, an integrated ablation device, a perfusion device, and an imaging device as described in any one of claims 1-14, wherein the integrated ablation device is connected to the ablation catheter, the perfusion device, and the imaging device respectively, the perfusion device is connected to the ablation catheter, and the integrated ablation device comprises an ablation generation module, a temperature detection module, an impedance detection module, an ECG signal detection module, an electrical stimulation / pacing signal module, an MCU central control module, an interactive control module, and an ablation control switch; The ablation generation module is used to generate and send ablation energy to the ablation electrode; The temperature detection module is used to receive the signal from the temperature sensor and feed it back to the MCU central control module; The impedance detection module is used to detect the impedance of the ablation electrode and / or the non-ablation electrode, and feed it back to the MCU central control module; The ECG signal detection module is used to detect electrocardiogram signals and feed them back to the MCU central control module; The electrical stimulation / pacing signal module is used to generate and transmit electrical stimulation / pacing signals through the ablation electrode under the control of the MCU central control module. The MCU central control module is signal-connected to the ablation generation module, the temperature detection module, the impedance detection module, the ECG signal detection module, the electrical stimulation / pacing signal module, the interactive control module, the ablation control switch, the ablation catheter, the perfusion device, and the imaging device. It is used to receive information from other modules, process it, and provide feedback and / or display the processed information. The interactive control module is used to display information and accept control commands from the user; The ablation control switch is used to control the application of ablation energy to the target tissue.

16. An ablation system, characterized in that, The device comprises at least two ablation catheters, an integrated ablation device, a perfusion device, and an imaging device as described in any one of claims 1-14, wherein the integrated ablation device is connected to at least two of the ablation catheters, the perfusion device, and the imaging device, and the perfusion device is connected to at least two of the ablation catheters, wherein the integrated ablation device comprises an ablation generation module, a temperature detection module, an impedance detection module, an ECG signal detection module, an electrical stimulation / pacing signal module, an MCU central control module, an interactive control module, and an ablation control switch; The ablation generation module is used to generate and send ablation energy to each of the ablation electrodes respectively; The temperature detection module is used to receive signals from each of the temperature sensors and feed them back to the MCU central control module; The impedance detection module is used to detect the impedance of each of the ablation electrodes and / or the non-ablation electrodes, and feed it back to the MCU central control module; The ECG signal detection module is used to detect electrocardiogram signals and feed them back to the MCU central control module; The electrical stimulation / pacing signal module is used to generate and transmit electrical stimulation / pacing signals through each of the ablation electrodes under the control of the MCU central control module. The MCU central control module is signal-connected to the ablation generation module, the temperature detection module, the impedance detection module, the ECG signal detection module, the electrical stimulation / pacing signal module, the interactive control module, the ablation control switch, at least two ablation catheters, the perfusion device, and the imaging device. It is used to receive information from other modules, process it, and provide feedback and / or display the processed information. The interactive control module is used to display information and accept control commands from the user; The ablation control switch is used to control the application of ablation energy to the target tissue.

17. The ablation system according to claim 15 or 16, characterized in that, The ablation system also includes a position detection module, which receives signals from the positioning sensor and feeds them back to the MCU central control module.

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