Ablation catheter, ablation system, and ablation method

Abstract

An ablation catheter (10) and an ablation system comprising the ablation catheter (10). The ablation catheter (10) comprises an insertion portion (1), an ablation main body (2), a catheter main body (3), and a control handle (4) which are connected in sequence. The insertion portion (1) comprises a screw-in component (11) capable of rotating under an external force to drill into and fix within a target tissue. The ablation main body (2) comprises an ablation electrode (21), a connecting member (22), and a temperature sensor (23). The catheter main body (3) comprises a non-ablation electrode (31) and an infusion channel (32). The non-ablation electrode (31) is spaced apart from the ablation electrode (21). During ablation procedures, the non-ablation electrode (31) does not come into contact with the target tissue. The ablation catheter (10) and the ablation system screw into the hypertrophic interventricular septum to perform ablation on the interventricular septum, allowing for easier control over the screw-in speed, thereby facilitating timely stopping or depth adjustment before penetrating the myocardial wall, preventing myocardial perforation, and reducing myocardial tissue damage by means of temperature detection and perfusion functions.

Description

Ablation catheter, ablation system and ablation method Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an ablation catheter, an ablation system and an ablation method. Background Art

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

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

[0004] Ablation treatments for hypertrophic obstructive cardiomyopathy (HOC) have been previously disclosed. These treatments typically target hypertrophic ventricular septum thicknesses of 10-20 mm caused by HOC. However, in clinical practice, patients often have significantly thicker ventricular septum thicknesses, reaching up to 30 mm. In these cases, the ablation catheters used in existing treatments cannot guarantee complete ablation.

[0005] At the same time, in the existing treatment plans, the detection of the ventricular septum in experiments relies on expensive three-dimensional imaging / CT imaging equipment, which is not conducive to the large-scale use of ventricular septum pulse ablation catheters. Smaller medical institutions cannot guarantee the completeness of equipment. In the absence of equipment, how to enable the surgeon to clearly understand the condition of the ventricular septum and the position of the ventricular septum pulse ablation catheter is also one of the technical problems that need to be solved in the existing technology. Summary of the Invention

[0006] To address the aforementioned technical issues in the prior art, the present invention provides an ablation catheter for treating hypertrophic cardiomyopathy, an ablation system incorporating such a catheter, and an ablation method. These catheters can be used with simple imaging equipment to determine the location of the ablation catheter and achieve better ablation results for areas with thicker ventricular septum. Furthermore, the ablation catheter of the present invention causes less damage to normal myocardial tissue during removal.

[0007] In order to achieve the above object, 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 protruding portion includes a screw-in component, which can be rotated and drilled into the target tissue under the action of external force and fixed;

[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 component, a first cavity arranged opposite to the first end, a second cavity formed by extending from the first cavity to the first end, and an irrigation hole running through the circumferential surface of the ablation electrode. The connector is arranged in the first cavity, and the connector extends out of the first cavity near one end of the catheter body and is connected to the catheter body. The connector has an axially penetrating first channel, and the first channel is connected to the second cavity, the irrigation hole and the infusion channel in the catheter body. The connector forms a plurality of second channels with the inner wall of the first cavity, and 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. When ablation is performed, the non-ablation electrode does not contact 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] Preferably, the screw-in component is in a three-dimensional spiral shape or a screw shape, and the end away from the ablation body is a pointed end.

[0015] More preferably, the pitch of the screw-in component gradually decreases from the distal end to the proximal end, and the pitch of the screw-in component is 0.25-1.5 times the diameter of the screw-in component.

[0016] More preferably, the diameter of the screw-in component gradually decreases from the proximal end to the distal end.

[0017] Preferably, the first end of the ablation electrode has a third cavity, and the screw-in component is connected in the third cavity.

[0018] More preferably, the screw-in component is fixedly connected to the third cavity, and the length of the screw-in component is greater than the axial length of the third cavity.

[0019] More preferably, 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.

[0020] Preferably, the extending portion further includes an insert, the length of the insert is less than or equal to the length of the screw-in member, and the insert is sleeved inside the screw-in member without contacting the screw-in member.

[0021] 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 is communicated with the second cavity.

[0022] Preferably, the perfusion hole is provided on a side of the second cavity close to the first cavity.

[0023] Preferably, the perfusion holes are arranged in a plurality of groups, and the plurality of groups of perfusion holes are distributed at intervals on the outer peripheral surface of the second cavity along the axial direction of the ablation electrode.

[0024] More preferably, each group of the perfusion holes comprises a plurality of perfusion sub-holes, and the plurality of perfusion sub-holes are distributed at intervals along the circumference of the ablation electrode.

[0025] More preferably, the projections of two adjacent perfusion holes on a plane perpendicular to the axial direction of the ablation electrode partially overlap.

[0026] Preferably, the protruding portion is conductive and insulated from the ablation electrode.

[0027] Preferably, the ablation body further 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 respectively located in different second channels.

[0028] Preferably, the ablation catheter further includes a guide member, which includes a connecting portion, a guide portion, and a guide hole passing through the connecting portion and the guide portion. The connecting portion is connected to the ablation catheter, and the inner wall of the guide portion is in a trumpet shape with a diameter gradually decreasing from one end away from the connecting portion to an end close to the connecting portion. The guide hole is connected to the lining wire channel in the ablation catheter.

[0029] More preferably, the guide member further includes a holding portion located between the connecting portion and the guiding portion, and the guide hole passes through the connecting portion, the holding portion and the guiding portion.

[0030] Another aspect of the present invention provides an ablation system, comprising the above-mentioned ablation catheter, an integrated ablation instrument, an irrigation device, and an imaging device, wherein the integrated ablation instrument is respectively connected to the ablation catheter, the irrigation device, and the imaging device, and the irrigation device is connected to the ablation catheter, and the integrated ablation instrument 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;

[0031] Wherein, the ablation generation module is used to generate and send ablation energy to the ablation electrode;

[0032] The temperature detection module is used to receive the signal from the temperature sensor and feed it back to the MCU central control module;

[0033] The impedance detection module is used to detect the impedance of the ablation electrode and / or the non-ablation electrode and feed back the impedance to the MCU central control module;

[0034] The ECG signal detection module is used to detect the electrocardiogram signal and feed it back to the MCU central control module;

[0035] The electrical stimulation / pacing signal module is used to generate and send electrical stimulation / pacing signals through the ablation electrode under the control of the MCU central control module;

[0036] 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, and is configured to receive information from other modules for processing, and to feed back and / or display the processed information;

[0037] The interactive control module is used to display information and accept control instructions from the user;

[0038] The ablation control switch is used to control the application of ablation energy to the target tissue.

[0039] Another aspect of the present invention provides an ablation system, comprising at least two of the above-mentioned ablation catheters, an integrated ablation instrument, an irrigation device, and an imaging device, wherein the integrated ablation instrument is respectively connected to the two ablation catheters, the irrigation device, and the imaging device, and the irrigation device is respectively connected to the two ablation catheters. The integrated ablation instrument 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.

[0040] Wherein, the ablation generation module is used to generate and send ablation energy to each of the ablation electrodes;

[0041] The temperature detection module is used to receive the signal of each temperature sensor and feed it back to the MCU central control module;

[0042] The impedance detection module is used to detect the impedance of each of the ablation electrodes and / or the non-ablation electrodes and feed back the impedance to the MCU central control module;

[0043] The ECG signal detection module is used to detect the electrocardiogram signal and feed it back to the MCU central control module;

[0044] The electrical stimulation / pacing signal module is used to generate and send electrical stimulation / pacing signals through each of the ablation electrodes under the control of the MCU central control module;

[0045] 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, and is configured to receive information from other modules for processing, and to feed back and / or display the processed information;

[0046] The interactive control module is used to display information and accept control instructions from the user;

[0047] The ablation control switch is used to control the application of ablation energy to the target tissue.

[0048] Preferably, the ablation system further comprises a position detection module, which receives a signal from a positioning sensor and feeds it back to the MCU central control module.

[0049] Another aspect of the present invention provides an ablation method using the ablation system comprising an ablation catheter, comprising the following steps:

[0050] S1: Subclavian vein / jugular vein puncture, the ablation catheter is delivered into the right ventricle through the delivery catheter;

[0051] S2: adjusting the angle and position of the delivery catheter and the ablation catheter under the guidance of an imaging device, and monitoring impedance and / or electrocardiogram waveform in real time, wherein the impedance is the impedance between the ablation electrode and the negative plate on the patient's body surface and / or the impedance difference between the ablation electrode and the non-ablation electrode;

[0052] S3: After the delivery catheter reaches the designated position, the insertion portion is rotated into the target tissue. During this process, whether the insertion portion is rotated into the target tissue and the depth of the rotation are determined based on the impedance change between the ablation electrode and the negative plate on the patient's body surface and / or the impedance difference change between the ablation electrode and the non-ablation electrode. After the ablation electrode reaches the target ablation area, the irrigation device is turned on.

[0053] S4: Adjust the parameters and perform ablation;

[0054] S5: After ablation is completed, electrical stimulation is performed to check whether the ablation is sufficient;

[0055] S6: spin out;

[0056] S7: If other points need to be ablated, repeat S2-S6;

[0057] S8: After all operations are completed, the catheter is removed from the body.

[0058] Preferably, the ablation catheter includes a positioning sensor, and step S2 further includes the ablation catheter using magnetoelectric positioning via the positioning sensor to determine the position of the ablation electrode.

[0059] Preferably, in step S1, the femoral artery is punctured, and the ablation catheter is delivered into the left ventricle via a delivery catheter.

[0060] Preferably, in step S3, an electrical signal is sent out by the ablation electrode, and whether the insertion portion is rotated in and the depth of the rotation are determined based on whether the electrical signal can be detected on the body surface and the change of the electrical signal.

[0061] Preferably, in step S5, the electrical stimulation examination is to apply a gradually increasing pacing voltage signal to the ablated tissue through the ablation electrode. When the applied pacing voltage signal is greater than or equal to the pacing voltage threshold, the electrocardiogram after the electrical signal is captured can be detected on the body surface, and the completed ablation damage range is the expected ablation range corresponding to the pacing voltage threshold; the pacing voltage threshold is the lowest voltage that can be transmitted through the ablated tissue to the non-ablated tissue after the expected ablation damage range is completed, and the pacing voltage threshold is proportional to the expected ablation damage range.

[0062] The main beneficial effects achieved by the present invention are as follows:

[0063] 1. Determining the position of existing ablation catheters requires hospitals to have comprehensive three-dimensional mapping systems. These systems cost millions of yuan, making them unaffordable for ordinary primary care hospitals and hindering the development of ablation procedures. The ablation catheter of the present invention, however, utilizes coordination between ablation and non-ablation electrodes (e.g., impedance detection based on the impedance difference between the two electrodes, changes in electrocardiogram signals, etc.) and / or positioning sensors to enable insertion and position determination guided by simple imaging equipment. This significantly reduces the basic requirements for performing the procedure and the learning curve for physicians, thereby expanding the scope of the procedure and facilitating its widespread adoption.

[0064] 2. In the prior art, if the insertion depth of the protruding portion exceeds its original length, there is a high probability that part of the myocardial tissue will be attached and removed during removal, causing damage to the ventricular septum. The inventors aim to minimize this damage. In one embodiment of the present invention, the inventors have optimized the configuration of the screw-in element, creating a tapered helical structure that facilitates insertion and removal. In another embodiment, the inventors have optimized the helical structure of the screw-in element, defining the relationship between its pitch and diameter to ensure a stable insertion process and avoid dislodging the target tissue during removal, which could cause excessive damage.

[0065] The ablation catheter and ablation system of the present invention can more simply and effectively treat hypertrophic cardiomyopathy, particularly for patients with a ventricular septum thickness of 20 mm or greater, with superior therapeutic efficacy and reduced damage to myocardial tissue. Furthermore, the ablation catheter and ablation system of the present invention are lower in cost and have a wider range of applications. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] FIG1 is a schematic structural diagram of an ablation catheter according to an embodiment of the present invention;

[0067] FIG2 is a schematic diagram of a partial structure of an ablation catheter according to an embodiment of the present invention;

[0068] FIG3 is a schematic structural diagram of the screw-in member 11;

[0069] FIG4 is a schematic structural diagram of an insert according to an embodiment of the present invention;

[0070] FIG5 is a schematic structural diagram of an insert according to an embodiment of the present invention;

[0071] FIG6 is a schematic structural diagram of an ablation electrode according to an embodiment of the present invention;

[0072] FIG7 is a schematic structural diagram of a perfusion hole;

[0073] FIG8 is a schematic structural diagram of a connector according to an embodiment of the present invention;

[0074] FIG9 is a schematic structural diagram of an ablation body according to an embodiment of the present invention;

[0075] FIG10 is a schematic structural diagram of an ablation body according to an embodiment of the present invention;

[0076] FIG11 is a schematic structural diagram of an ablation body and a catheter body according to an embodiment of the present invention;

[0077] FIG12 is a schematic structural diagram of a guide member according to an embodiment of the present invention;

[0078] FIG13 is a schematic structural diagram of a guide member according to an embodiment of the present invention;

[0079] FIG14 is a partial schematic diagram of an ablation catheter according to one embodiment of the present invention;

[0080] FIG15 is a schematic diagram showing the impedance change of the ablation electrode when it is in different positions;

[0081] FIG16 is a schematic diagram of determining the ablation range through electrocardiogram signals;

[0082] FIG17 is a schematic diagram of an ablation system according to an embodiment of the present invention;

[0083] FIG18 is a schematic diagram of the use of an ablation system according to one embodiment of the present invention;

[0084] FIG19 is a schematic diagram of an ablation system according to an embodiment of the present invention;

[0085] FIG20 is a schematic diagram of the ablation catheter in the heart;

[0086] Figure 21 shows the electrocardiogram of lead V1 when the ablation catheter is located at different positions. DETAILED DESCRIPTION

[0087] definition

[0088] Distal: In this specification, when referring to the "distal side" of the device of the present invention, the term refers to the side relatively away from the user.

[0089] Proximal side: In this specification, when referring to the "proximal side" of the device of the present invention, the term refers to the side relatively closer to the user.

[0090] Distal end: In this specification, when the system or device of the present invention is described with reference to the "distal end", the term generally refers to the end that is relatively far away from the user.

[0091] Proximal end: In this specification, when referring to the "proximal end" when describing the system or device of the present invention, the term generally refers to the end that is relatively close to the user.

[0092] Terms such as "mounted," "connected," "connect," and "fixed" should be interpreted broadly. For example, they may refer to fixed or detachable connections, or integration; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components or interaction between two components, unless otherwise specifically defined. Those skilled in the art will understand the specific meanings of these terms in the present invention based on specific circumstances.

[0093] Preferred embodiments of the present invention are described below with reference to the accompanying drawings. Those skilled in the art will appreciate that the embodiments or examples described below with reference to the accompanying drawings are intended only to illustrate the best modes for implementing 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, and such improvements and variations are intended to fall within the scope of the present invention.

[0094] Figures 1 and 2 provide an ablation catheter 10 according to an embodiment of the present invention, which includes an insertion portion 1, an ablation body 2, a catheter body 3, and a control handle 4, which are connected in sequence from the distal end to the proximal end. 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), which can be rotated and fixed into the target tissue under the action of an external force, thereby fixing the ablation catheter 10 at the target ablation position, preventing the ablation catheter 10 from shifting during the ablation of the target tissue and damaging other non-target tissues or affecting the ablation effect. The ablation body 2 includes an ablation electrode 21 as a shell, a connector 22, and a temperature sensor 23 (Figures 9-10). The ablation electrode 21 comprises a first end connected to the screw-in element 11, a first cavity 211 disposed opposite the first end, a second cavity 212 extending from the first cavity 211 toward the first end, and an irrigation hole 213 extending through the axial surface of the ablation electrode 21 (Figure 6). The ablation electrode 21 is constructed of a conductive material and is configured to contact the target tissue and emit ablative energy, such as radiofrequency energy or pulsed energy, to ablate the target tissue. The ablation electrode 21 can be inserted into the target tissue along with the insertion portion 1 or abut the target tissue surface to ablate the target tissue. The connector 22 connects the ablation body 2 and the catheter body 3. The temperature sensor 23 senses the temperature of the ablation electrode 21. Based on the measured temperature data, the power of the ablation electrode 21 is adjusted to ensure that the temperature at the ablation site remains stable while not exceeding a threshold. This prevents heat accumulation during ablation of the target tissue, which could lead to excessive temperatures. This prevents the formation of eschar in surrounding tissues due to excessive electrode temperature, potentially causing 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, or J type thermocouple. In this specification, the X-axis in Figure 1 represents the axial direction of the ablation catheter 10 of the present invention.

[0095] The insertion portion 1 includes a screw-in member 11, as shown in FIG3A . The screw-in member 11 is in the shape of a three-dimensional spiral. The end of the screw-in member 11 away from the ablation body 2 is a pointed end. The catheter body 3 is configured to be able to drive the screw-in member 11 to rotate under the action of an external force to drill into and fix it in the target tissue. Since the end of the screw-in member 11 away from the catheter body 3 is a pointed end, this allows the screw-in member 11 to penetrate the target tissue more easily. Furthermore, since the screw-in member 11 is in the shape of a three-dimensional spiral, when the screw-in member 11 drills into the target tissue, the screw-in member 11 can abut against the target tissue around it and prevent the ablation electrode 21 from moving axially and radially, allowing the screw-in member 11 to be reliably fixed in the target tissue. After ablation of a target tissue target point is completed, the screw-in member 11 can be unscrewed through the catheter body 3 to release the screw-in member 11 from the fixed state with 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 target points are ablated.

[0096] Furthermore, as shown in FIG2 , in some embodiments, the ablation body 2 is roughly cylindrical, and the screw-in part 11 can extend in a three-dimensional spiral in the axial direction of the cylindrical ablation body 2 in a direction away from the ablation body 2, and as shown in FIG3 , the end of the screw-in part 11 away from the ablation electrode 21 can be a tip. The screw-in part 11 can be rotated by the catheter body 3 to drill into and fix into the target tissue. Optionally, the tip of the screw-in part 11 can be conical, or it can be other relatively sharp shapes obtained by grinding the end face of the free end of the screw-in part 11, such as a thin sheet. In other words, the shape of the tip of the screw-in part 11 is not limited, and it is intended to make it easier for the screw-in part 11 to penetrate the target tissue.

[0097] In one embodiment of the present invention, the wire diameter of the screw-in part 11 is 0.1-0.4mm, preferably 0.15-0.3mm, the diameter is between 0.5-2mm, and the number of spiral turns is between 2-10 turns. In a preferred embodiment, the length of the screw-in part 11 is 1-8mm, and more preferably, the length of the screw-in part 11 is 3mm. 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. If the pitch of the screw-in part 11 is less than 0.25 times the diameter, it will be difficult to screw into the myocardial tissue, which is not conducive to fixation, and the target tissue will be increased when it is screwed out, causing excessive damage. If the ratio between the pitch and diameter of the screw-in part 11 is too large, it will cause shaking and instability during the screw-in process when the material hardness of the screw-in part 11 remains unchanged. By optimizing the ratio between the pitch and diameter of the screw-in component 11, the present invention can facilitate the screw-in component 11 to be screwed into the target tissue while reducing damage to the target tissue.

[0098] In one embodiment of the present invention, the screw-in member 11 is in the shape of a cylindrical helix. In another embodiment, the screw-in member 11 is in the shape of a conical helix, i.e., 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 in the shape of a conical helix, it is easier to screw into the target tissue and can reduce damage to the target tissue.

[0099] In other embodiments, the screw-in component 11 may also be a screw-shaped structure, that is, the main body is cylindrical, and at least one sharp spiral protrusion is spirally formed on the outer circumference thereof ( FIG. 3B ).

[0100] In addition, in one embodiment of the present invention, the pitch of the screw-in component 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 component 11 drilling into the target tissue, and the proximal end is more firmly fixed to the electrode.

[0101] It should be noted that during treatment, in some embodiments, the user can operate the catheter body 3 to adjust the depth of the screw-in member 11 penetrating the target tissue as needed, thereby better performing ablation therapy. 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 screw-in member 11 on the ablation body 2 to drill into or out of the target tissue.

[0102] In one embodiment of the present invention, the screw-in part 11 is made of an insulating material, or made of a metal material but its outer surface is made of an insulating material. In this embodiment, the screw-in part 11 only plays the role of screwing in and fixing. In another embodiment of the present invention, the screw-in part 11 is a spiral electrode head, which is made of a conductive material. The conductive material includes but is not limited to platinum-iridium alloy, gold, nickel-cobalt-chromium-molybdenum alloy, stainless steel, titanium alloy and other metals. The screw-in part not only plays the role of screwing in and fixing, but also has the functions of ablation, mapping, pacing and the like. When the screw-in part 11 is made of a conductive material, the screw-in part 11 can be connected to the ablation electrode 21 and serve as a part of the ablation electrode 21, or the screw-in part 11 and the ablation electrode 21 are insulated from each other and are connected to the screw-in part 11 and the ablation electrode 21 respectively through a separately set wire. The screw-in part 11 and the ablation electrode 21 have opposite or same polarity.

[0103] The screw-in member 11 is fixed to the ablation electrode 21. When the ablation electrode 21 of the present invention has a third cavity 214 at its first end (as shown in FIG6 ), the screw-in member 11 is connected to the third cavity 214. In one embodiment of the present invention, the screw-in member 11 is fixedly connected to 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 is exposed outside the third cavity 214, thereby facilitating screwing into the target tissue. In addition, the screw-in member 11 can also be retractably connected to 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, when the ablation catheter 10 is not in use and / or is being inserted into the human body, the screw-in member 11 is housed within the ablation body 2. When it reaches the vicinity of the target tissue, the screw-in member 11 extends out of the ablation body 2. This configuration can reduce the risk of the tip of the ablation catheter 10 accidentally damaging other tissues during surgery. The screw-in member 11 can be telescopically connected to the third cavity 214 using methods commonly used in the art, such as extending or retracting the screw-in member 11 into the third cavity 214 by means of an electromagnetic spring, a motor, and a screw / gear.

[0104] Furthermore, as shown in Figures 4-5, the insertion portion 1 also includes an insert 12, which is configured to be inserted into the target tissue and / or to 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 present invention, the length of the screw-in member 11 is greater than the length of the insert 12, so that when the screw-in member 11 is not screwed in, the insert 12 is enclosed in the screw-in member 11 and the insert 12 does not injure human tissue. Like the screw-in member 11, the insert 12 can be insulating or conductive. When the insert 12 is conductive, it can be connected to the ablation electrode 21, serve as a part of the ablation electrode 21, or be insulated from the ablation electrode 21, and be connected to the insert 12 and the ablation electrode 21 respectively through separately arranged wires.

[0105] In one embodiment of the present invention, the insert 12 is a hollow structure having a through-hole 121 extending through the circumferential surface of the insert 12 ( FIG. 5 ). The proximal end of the insert 12 communicates with 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 present invention, the insert 12 is retractable. That is, when not in use and / or while the ablation catheter 10 is entering the human body, the insert 12 is housed within the ablation body 2 . Upon reaching the vicinity of the target tissue, the insert 12 extends out of the ablation body 2 . This configuration can reduce the risk of the tip of the ablation catheter 10 accidentally damaging other tissues during surgery. Similar to the screw-in element 11 , the retractable control of the insert 12 can be achieved using methods commonly used in the art.

[0106] Referring to FIG6 , the distal end of the ablation electrode 21 has a first end connected to the screw-in member 11. In the present embodiment, the first end has a third cavity 214 extending toward the second cavity 212, and the screw-in member 11 is fixed in the third cavity 214. However, as long as the first end of the ablation electrode 21 can fix the screw-in member 11, there is no particular limitation on its structure. For example, the first end may be a solid structure, a portion of the screw-in member 11 may be buried in the first end to be fixed to the first end, or the screw-in member 11 may be integrally formed with the first end. The screw-in member 11 and the ablation electrode 21 may be connected by methods known in the art according to actual use. For example, they may be fixedly connected by bonding, riveting, press-fitting, welding, etc., or they may be detachably connected by snap-fitting, threading, etc.

[0107] A first cavity 211 is provided at the proximal end of the ablation electrode 21, opposite the first end. A connector 22 (as shown in FIG8 ) is disposed within the first cavity 211. The second cavity 212, the irrigation hole 213, and the first channel 223 in the connector 22 are connected to the infusion channel 32 (as shown in FIG11 ) in the catheter body 3. Liquids such as saline delivered by the infusion channel 32 are transported through the first channel 223 to the second cavity 212, where they are then infused through the irrigation hole 213 into the ablation electrode 21 and the target tissue, thereby reducing the temperature of the ablation electrode 21 and the target tissue.

[0108] The ablation electrode 21 can be made of any material commonly used in the art for electrode manufacturing, without particular limitation, such as gold, copper, titanium alloy, platinum, stainless steel, etc. In one embodiment, the ablation electrode 21 is coated with arc-proof glue to reduce the generation of arcs during ablation and improve safety.

[0109] In addition, in other embodiments of the present invention, the ablation body 2 includes an insulating shell and at least two ablation electrodes spaced axially along the insulating shell. In this embodiment, the structure of the insulating shell can be the same as the structure of the ablation electrode 21 of the present invention, which will not be described here. The only difference is that it is non-conductive. At least two ablation electrodes can be ring electrodes sleeved on the insulating shell, which are respectively connected to the control handle through wires. A number of perfusion holes are provided on the circumference of the ring electrode. Reasonable electrode spacing and ablation parameters are set between at least two ablation electrodes, and a continuous ablation area can be created after the ablation is completed. 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.

[0110] In the present invention, the ablation electrode 21 can not only be used to ablate the target tissue but also to determine the position of the ablation catheter 10 before ablation begins. Because the conductivity of blood and muscle differs, and the conductivity varies at different locations within the same muscle tissue, the impedance of the ablation electrode 21 varies at different locations (a circuit is formed by providing a negative electrode plate on the body surface). As shown in Figure 15 , when the ablation electrode 21 is only in contact with blood and has not entered the interventricular septum (I in the figure), its impedance is low. However, as the ablation electrode 21 enters the interventricular septum (II in the figure) and reaches the center of the interventricular septum (III in the figure), its impedance gradually increases, reaching its maximum at the center of the interventricular septum (III in the figure). As the ablation electrode 21 continues to move deeper from the center of the interventricular septum (IV-V in the figure), its impedance gradually decreases. Therefore, the position of the ablation catheter 10 can be easily identified by observing the impedance changes of the ablation electrode 21 as it moves within the body.

[0111] In addition, the ablation electrode 21 can cooperate with the non-ablation electrode 31 to send out electrical stimulation / pacing signals. The position of the ablation electrode 21 can be determined by whether the above signals and the difference in signals can be detected on the body surface. In short, during the insertion of the ablation catheter 10, the ablation electrode 21 continuously sends out 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 contacting the target tissue, the signals will be transmitted to the body surface and detected, which will be reflected in the electrocardiogram. In addition, the emitted electrical signals will be different when the target tissue is the left and right ends of the ventricular septum. Specifically, due to the existence of the left and right bundle branches in the ventricular septum, when the left and right bundle branches receive electrical signals and feed them back in the electrocardiogram, the distance between the two and the signal source will change in the electrocardiogram. The insertion distance can be determined by the changes in the electrocardiogram. As shown in FIG21A , when the ablation electrode 21 is located at different positions (1-5), the electrocardiogram in lead V1 is shown in FIG21B , where I represents the right ventricle, II represents the ventricular septum, and III represents the left ventricle.

[0112] Furthermore, after emitting ablation energy, the ablation electrode 21 can also cooperate with the non-ablation electrode 31 to emit an electrical stimulation / pacing signal to determine the damage range of the target tissue. Specifically, the patient's own electrocardiogram is shown in Figure 16C (a). According to the basic principle of ablation, after the target tissue is ablated, the cells of the target tissue undergo necrosis during radiofrequency ablation or apoptosis after irreversible electroporation during pulse 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 tissue outside. The electrocardiogram at this time is shown in Figure 16C (c), which is an uncaptured electrocardiogram after ablation. By applying an electrical signal (electrical stimulation / pacing signal) with a gradually increasing voltage to the ablated tissue, simulating the pacing function, stimulating the target tissue, and determining whether the captured electrocardiogram can be detected on the body surface at different voltage values, the corresponding effective ablation range can be determined. When the applied pacing voltage signal is greater than or equal to the pacing voltage threshold, a captured electrocardiogram (ECG) can be detected on the body surface (as shown in Figure 16C, panel b). The completed ablation lesion range is the intended ablation lesion range corresponding to that 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 intended ablation lesion range is completed. For example, assuming the ablation range is 10 mm (from the ablation catheter), the corresponding pacing voltage threshold is 5 V. When the applied voltage is less than 5 V, the target tissue will not respond, and the signal cannot be detected. However, when it exceeds 5 V, it can be detected, thereby determining the ablation range of this ablation. The pacing voltage threshold is proportional to the intended ablation lesion range. As shown in Figures 16A and 16B, if the ablation lesion range X is smaller than the ablation lesion range Y, the pacing voltage threshold corresponding to the ablation lesion range X is smaller than the pacing voltage corresponding to the ablation lesion range Y.

[0113] The perfusion holes 213 of the present invention are arranged on the circumferential surface of the ablation electrode 21, and can directly perfuse the liquid into the target tissue. The liquid circulation method is an external circulation method. Compared with the method in which the liquid circulates only in the ablation catheter 10, the cooling effect is better. The reason is that, on the one hand, the liquid can not only cool the ablation electrode 21, but also cool the target tissue. The simultaneous cooling of the two accelerates the cooling efficiency; on the other hand, the cooling effect of the internal circulation on the ablation electrode 21 is lower than that of the external circulation at the same flow rate. In addition, the second cavity 212 of the present invention can play a buffering role on the delivered liquid, reduce the pressure of the liquid flowing out of the perfusion hole 213, and avoid damage to the tissue caused by excessive pressure.

[0114] In one embodiment of the present invention, the irrigation holes 213 are located on the side of the second cavity 212 adjacent to the first cavity 211, thereby enabling the second cavity 212 to function as a water reservoir and reducing the pressure at the irrigation holes 213. As shown in Figure 7, in a preferred embodiment, the irrigation holes 213 are arranged in multiple groups, spaced apart along the outer circumference of the second cavity 212 along the axial direction of the ablation electrode 21. In a preferred embodiment, each group of irrigation holes 213 comprises multiple irrigation sub-holes, which are spaced apart along the circumference of the ablation electrode 21 (7B). In another preferred embodiment, the projections of two adjacent irrigation holes 213 onto a plane perpendicular to the axial direction of the ablation electrode 21 overlap (7A). This arrangement allows for more even distribution of the liquid, increases the contact area with the ablation electrode 21 and the target tissue, and improves cooling efficiency. The shape of the irrigation holes 213 is not particularly limited and can be selected from one or more of circular, elliptical, arcuate, fan-shaped, arched, and polygonal.

[0115] The structure of the connector 22 and the connection between the ablation body 2 and the catheter body 3 are described below with reference to Figures 8-11. Figure 8 is a schematic cross-sectional view of the connector 22 along a plane parallel to the X-axis. Figure 9 is a schematic cross-sectional view of the connector 22 and the ablation electrode 21. Figure 10 is a schematic cross-sectional view of the connector 22 and the ablation electrode 21 after connection, along a plane perpendicular to the X-axis. Figure 11 is a schematic cross-sectional view of the ablation body 2 and the catheter body 3 after connection, along a plane parallel to the X-axis. As shown in the figures, the connector 22 includes a first connection portion 221 connected to the ablation electrode 21, a second connection portion 222 connected to the catheter body 3, a first channel 223 axially extending through the connector 22, and a second channel 224 formed by the connector 22 and the inner wall of the first cavity 211 of the ablation electrode 21. The first connection portion 221 is disposed within the first cavity 211, and the proximal end of the second connection portion 222 extends beyond the ablation electrode 21 to connect to the catheter body 3. In one embodiment of the present invention, as shown in Figures 9 and 11, 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 to enable the first connecting portion 221 to enter the first cavity 211. The portion of the first cavity 211 adjacent to the second cavity 212 has a flange 2111, against which the first connecting portion 221 of the connector 22 abuts. The second connecting portion 222 is a retaining protrusion. The side of the catheter body 3 adjacent to the ablation body 2 has a retaining recess 35 that mates with the second connecting portion 222. The connector 22 is secured to the catheter body 3 by extending the second connecting portion 222 into the retaining recess 35. The connector 22 can be fixedly connected to the ablation body 2 and the catheter body 3 by bonding, riveting, press-fitting, welding, or other methods, or can be removably connected by snap-fitting, threading, or other methods. The second channel 224 is used to accommodate other components, such as the temperature sensor 23 and the electrical conductor 24 connected to the ablation electrode 21. Furthermore, as needed, those skilled in the art may increase the number of second channels 224 and place different components in different second channels 224, such as a positioning sensor, an electrical conductor connected to the screw-in member 11, and an electrical conductor connected to the insert 12. The second channels 224 are not connected to the second cavity 212. Therefore, liquid does not enter the second channels 224, thereby reducing interference with the components disposed therein. Furthermore, separating the different components can also reduce interference between them. The connector 22 is insulated and is made of an insulating material, or at least has an insulating surface.

[0116] In addition, 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 by electric field positioning, magnetic field positioning, electromagnetic field positioning, etc. In one embodiment of the present invention, the ablation catheter 10 uses magnetoelectric positioning to determine the position of the ablation electrode 21 through the positioning sensor. That is, a magnetic field generator is set under the surgical area / bed to construct an overall magnetic field, and a positioning sensor with a magnetic coil is set in the catheter to monitor the changes in the magnetic field to determine the position of the catheter. In one embodiment, the positioning sensor of the present invention does not sense the positional relationship between itself and 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 of each other. When the distance between the two reaches a set distance threshold, ablation is performed, which can ensure the ablation effect and achieve sufficient ablation of the entire hypertrophic ventricular septum. The above-mentioned distance threshold refers to the maximum distance between the two ablation catheters 10 that can make A and B at least partially overlap when the ablation lesion ranges of the two ablation catheters 10 are A and B respectively. The ablation lesion 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 lesion range. For example, when the ablation energy is pulsed, the pulse width, inter-pulse delay, pulse voltage, etc. can be adjusted. In one embodiment, two positioning sensors use microwave positioning to sense the distance between each other.

[0117] As shown in Figures 1 and 2, in some embodiments, the catheter body 3 includes a non-ablative electrode 31. The non-ablative electrode 31 can be made of any commonly used electrode material in the art, without particular limitation, such as gold, copper, titanium alloy, platinum, stainless steel, and the like. In one embodiment of the present invention, the non-ablative electrode 31 is an annular structure with a length of 0.5-5 mm. An electrical conductor is provided within the catheter body 3 and connected thereto, establishing an electrical connection with the control handle 4.

[0118] The non-ablation electrode 31 is not used to emit ablation energy. Instead, it is used to detect signal differences (e.g., impedance differences) with the ablation electrode 21 during ablation to determine the position of the ablation electrode 21. It also cooperates with the ablation electrode 21 to apply pacing voltage signals and detect electrocardiogram signals to determine the position of the ablation electrode 21 and the extent of the ablation lesion. The non-ablation electrode 31 is separated from the ablation electrode 21 by 2-30 mm (spacing D in Figures 1 and 2). Within this distance, a suitable signal difference can be more easily obtained without affecting the ablation effect. Position determination is similar to distance determination using a single ablation electrode 21. Due to the different electrical conductivities of blood and muscle, and different areas of the same tissue, the impedance of the spaced-apart ablation electrode 21 and non-ablation electrode 31 will vary depending on the media in which they are located. This impedance difference varies as the position of the ablation catheter 10 near the target tissue changes. Therefore, the position of the ablation electrode 21 can be determined based on the impedance difference before ablation. Specifically, when entering the left and right ventricles but not extending into the interventricular septum, the ablation electrode 21 and the non-ablation electrode 31 are both in contact with the blood in the ventricles, and the impedances detected by the two are relatively close or almost the same. As the insertion portion 1 extends, the ablation electrode 21 gradually contacts the target tissue (hypertrophic myocardium of the interventricular septum), while the non-ablation electrode 31 set at intervals is still in contact with the blood, and the impedances of the two will differ. Furthermore, as the depth of the ablation electrode 21 enters changes (from partial contact to complete extension into the interventricular septum), the impedance difference becomes larger. Therefore, the degree of insertion can be determined by the change in impedance. Compared with using the ablation electrode 21 alone to determine the position, the impedance difference value is larger and the accuracy is higher when using the combination of the ablation electrode 21 and the non-ablation electrode 31 to determine the position by the change in impedance difference. The non-ablation electrode 31 can be multiple and the spacing between multiple non-ablation electrodes 31 can be set arbitrarily.

[0119] Regarding the components that require conductivity, such as the ablation electrode 21, non-ablation electrode 31, temperature sensor 23, and positioning sensor in the ablation catheter 10 of the present invention, 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.

[0120] In some embodiments, the catheter body 3 includes an infusion channel 32, an elastic tube 33 and an outer tube 34, and the elastic tube 33 is sleeved on the inner circumference of the outer tube 34. Specifically, as shown in Figure 11, the elastic tube 33 is formed by a plurality of silk threads coiled around the inner circumference of the outer tube 34. The silk threads can be made of metal 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 not only improves the overall support of the ablation catheter 10, but also improves the anti-bending property of the ablation catheter 10 during the torsion process. The elastic tube 33 is hollow to form the infusion channel 32, which is connected to the ablation electrode 21 for delivering liquid to the ablation electrode 21.

[0121] In some embodiments, the catheter body 3 also includes an adjustable bend, which is 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 through the adjustable bend, thereby changing the position angle of the insertion part 1 and the ablation body 2, thereby facilitating surgical manipulation.

[0122] During an ablation procedure, a liner wire enters the ablation catheter 10 from the proximal end thereof, guiding and supporting the ablation catheter 10. However, due to the small diameter of the liner wire, the diameter of the corresponding liner wire channel in the ablation catheter 10 is also small. Therefore, when inserting the liner wire into the liner wire channel, it is often difficult to align the liner wire with the entrance of the liner wire channel, resulting in difficulty in inserting the liner wire into the liner wire channel. Therefore, in some embodiments, the ablation catheter 10 of the present invention further includes a guide member 6, which is used to guide the liner wire into the ablation catheter 10. As shown in Figures 12-13, the guide member 6 includes a connecting portion 61, a gripping portion 62, a guiding portion 63, and a guide hole 64 extending through the connecting portion 61, the gripping portion 62, and the guiding portion 63, which are arranged in sequence from the distal end to the proximal end. The connecting portion 61 is used to connect the guide member 6 to the ablation catheter 10. In a preferred embodiment, the connecting portion 61 is connected to the ablation catheter 10 by a thread, and includes a threaded structure 611 and a boss 612 corresponding to the threaded structure on the ablation catheter 10. The boss 612 can extend into a corresponding groove on 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 clamping, welding, etc. The gripping portion 62 is located between the connecting portion 61 and the guide portion 63 to facilitate user operation and gripping. In some embodiments, the guide member 6 may also not include the gripping portion 62. When in use, the guide member 6 is gripped by the connecting portion 61 and / or the guide portion 63. The inner wall of the guide portion 63 is in the shape of a trumpet with a diameter gradually decreasing from the end away from the connecting portion 61 to the end close to the connecting portion 61. The opening of the guide portion 63, which is closer to the user, is larger, facilitating the insertion of smaller-diameter liner wires. The opening gradually decreases in diameter. Therefore, even if the liner wire initially fails to enter the guide hole 64, the tapered inner wall of the guide portion 63 allows it to slide into the guide hole 64, simplifying operation and saving time. The guide hole 64 axially extends through the guide member 6 and communicates with the liner wire channel in the ablation catheter 10, allowing the liner wire to enter the ablation catheter 10 directly after entering the guide member 6. In one embodiment of the present invention, the liner wire channel and the infusion channel 32 are the same channel.

[0123] In one embodiment of the present invention, as shown in FIG14 , an ablation catheter 10 includes a three-way valve 5 connected to an operating handle 4. One opening of the three-way valve 5 can communicate with an irrigation device. A guide 6 is connected to the other opening of the three-way valve 5. The other end of the guide 6 is connected to a torque transmitter 7, and a liner wire is fixed in the center hole of the torque transmitter 7. Because the liner wire is thin and difficult for the user to grasp and manipulate, the torque transmitter 7 is provided. By operating the torque transmitter 7, the liner wire can be manipulated, transmitting the torque generated by twisting the proximal end to the distal end.

[0124] FIG17 is a schematic diagram of an ablation system according to the present invention. As shown in FIG17-18 , the ablation system according to the present invention includes an integrated ablation device, an ablation catheter 10 according to the present invention, an irrigation device, and an imaging system, each connected to the integrated ablation device. The irrigation 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 irrigation fluid is saline. In other embodiments, the irrigation device can be controlled by the integrated ablation device to infuse other fluids into the ablation catheter 10. The purpose is to improve the electrical and thermal conductivity of the ablated tissue, maintain impedance balance, keep the impedance at a relatively stable state, reduce the temperature of the ablated tissue, increase the humidity of the ablated tissue, and fundamentally prevent the formation of scabs due to drying and heating of the ablated tissue without causing serious side effects. The irrigation device has an adjustable irrigation rate, which can be controlled in real time by the integrated ablation device during irrigation. 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 surgery. The imaging device can be a combination of one or more of a three-dimensional imaging system, CT, MR, DSA, etc. In the present invention, in order to reduce surgical requirements, reduce hospital costs, and expand the scope of use of this ventricular septum ablation system, in this system, the imaging device is a DSA device that can meet the minimum surgical imaging requirements. There is no need for a complete and expensive full set of imaging systems, so that non-tertiary township hospitals can also meet the surgical conditions, thereby expanding the scope of surgical benefits and facilitating promotion. Compared with CT, DSA can reduce the operator's radiation dose and improve the operator's safety. When performing pulse ablation, a negative plate 20 needs to be set outside the patient's body.

[0125] 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. Among them, the ablation generation module is used to generate and send ablation energy to the ablation electrode 21. The ablation energy is radio frequency energy or pulse energy. In addition, in a preferred embodiment, the ablation generation module can also emit one or more of low-temperature energy, laser, chemical, electroporation, high-intensity focused ultrasound or ultrasound and microwave. The temperature detection module is used to receive the signal from the temperature sensor 23 of the ablation catheter 10 and feed it back to the MCU central control module. The impedance detection module is used to detect the impedance of the ablation electrode 21 and / or the non-ablation electrode 31 and feed it back to the MCU central control module. The ECG signal detection module is used to detect the electrocardiogram signal and feed it back to the MCU central control module. The electrical stimulation / pacing signal module is used to generate and send 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, 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 10, the perfusion device and the imaging device signal, and is used to receive information from other modules for processing, and to feed back and / or display the processed information. For example, after receiving the temperature feedback from the temperature detection module, the MCU central control module controls the perfusion device to change the perfusion rate according to the customized threshold temperature, increases the perfusion rate when the threshold temperature is exceeded, and reduces the perfusion rate when the threshold temperature is lower than the threshold temperature. Preferably, the customized threshold temperature is usually 40-70 degrees, preferably 55 degrees. Except for the stopped state, during the process of maintaining perfusion, the perfusion rate requires setting a minimum flow rate threshold, and preferably the minimum flow rate threshold is 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. The ablation function is activated when the user steps on it. A user can also customize a certain time, such as continuous footstepping within 3 seconds, to control different ablation functions / modes. In one embodiment of the present invention, the ablation system also 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.

[0126] When using the above-mentioned ablation system for ablation, the following steps are followed: S1: Puncture the subclavian vein / jugular vein and deliver the ablation catheter 10 into the right ventricle through the delivery catheter; S2: Under the guidance of the imaging device, adjust the angle and position of the delivery catheter and the ablation catheter 10, and monitor the impedance and / or electrocardiogram waveform in real time, where the impedance is the impedance between the ablation electrode 21 and the patient's body surface negative plate 20 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, rotate the insertion portion 1 into the target area. Target tissue, during which whether the insertion portion 1 is rotated in and the depth of rotation are determined according to the impedance change between the ablation electrode 21 and the negative 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 equipment is turned on; S4: adjust the parameters for ablation; S5: after the ablation is completed, perform electrical stimulation to check whether the ablation is sufficient; S6: rotate out; S7: if other points need to be ablated, repeat S2-S6; S8: after all operations are completed, the catheter is removed from the body.

[0127] In a preferred embodiment of the present invention, the ablation catheter 10 includes a positioning sensor, and step S2 further includes the ablation catheter 10 using magnetoelectric positioning via the positioning sensor to determine the position of the ablation electrode 21. In one embodiment, unlike the above-mentioned subclavian vein / jugular vein puncture and delivery of the ablation catheter 10 into the right ventricle via a delivery catheter, alternatively, in step S1, the femoral artery is punctured and the ablation catheter 10 is delivered into the left ventricle via a delivery catheter. In one embodiment, step S3 can also include emitting an electrical signal via the ablation electrode 21, and determining whether the insertion portion 1 has been rotated in and the depth of the rotation based on whether the electrical signal can be detected on the body surface and changes in the electrical signal. In one embodiment, in step S5, the electrical stimulation check is to apply 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, the electrocardiogram after the electrical signal is captured can be detected on the body surface, and the completed ablation damage range is the expected ablation range corresponding to the pacing voltage threshold; the pacing voltage threshold is the lowest voltage that can be transmitted through the ablated tissue to the non-ablated tissue after the expected ablation damage range is completed, and the pacing voltage threshold is proportional to the expected ablation damage range.

[0128] In one embodiment, the insertion portion 1 is electrically insulated, and the ablation electrode 21 transmits radiofrequency energy to the target tissue, causing thermal damage to the cells in the target tissue, thereby achieving the purpose of ablation. In another embodiment, the insertion portion 1 is electrically insulated, and the ablation electrode 21 transmits pulse energy to the target tissue. In this case, a negative electrode plate 20 is provided on the body surface, causing irreversible electroporation of the cells in the target tissue, thereby achieving the purpose of ablation. In another embodiment, the insertion portion 1 is conductive and has opposite polarity to the ablation electrode 21. The ablation electrode 21 transmits pulse energy to the target tissue. In this case, the ablation catheter 10 operates as a pulsed bipolar ablation catheter, causing irreversible electroporation of the cells in the target tissue, thereby achieving the purpose of ablation. In another embodiment, the insertion portion 1 is electrically insulated, and the ablation body includes at least two ablation electrodes 21 with opposite polarity. The ablation electrode 21 transmits pulse energy to the target tissue. In this case, the ablation catheter 10 operates as a pulsed bipolar ablation catheter, causing irreversible electroporation of the cells in the target tissue, thereby achieving the purpose of ablation.

[0129] Figure 19 shows a schematic diagram of another ablation system according to the present invention. Compared to the single-ablating catheter ablation system shown in Figure 17 , this embodiment differs in that it includes two ablation catheters 10, each connected to an integrated ablation device and an infusion device. All other components are identical to the ablation system shown in Figure 17 . Figure 20 illustrates a single ablation catheter performing ablation in the left ventricle (A) and right ventricle (B). During ablation using this embodiment, the subclavian / jugular vein is punctured, and one ablation catheter 10 is delivered to the right ventricle via a delivery catheter and then threaded into the interventricular septum. The other ablation catheter 10 is delivered to the left ventricle via a delivery catheter through a femoral artery puncture and then threaded into the interventricular septum. All other steps are identical to those for the single-ablating catheter ablation system shown in Figure 17 .

[0130] According to actual usage needs, the ablation system of the present invention can also include more than two ablation catheters 10, and each ablation catheter 10 is connected to the integrated ablation instrument and the perfusion equipment respectively. The connection method and operation method of other components are the same as those of the ablation system shown in Figures 17 and 19. Those skilled in the art can operate the ablation system comprising more than two catheters 10 based on the above description of the present invention.

[0131] In addition, regarding the polarity of the ablation electrode 21 and whether the insertion part 1 is conductive, the ablation system shown in Figure 19 can also be configured as follows: the insertion parts 1 of the two ablation catheters 10 are electrically insulated, the two ablation electrodes 21 have the same / different polarity but are unrelated to each other, and emit pulse energy. A negative plate 20 is attached to the human body, and each ablation electrode 21 performs single-stage ablation; or the insertion parts 1 of the two ablation catheters 10 are electrically insulated, the two ablation electrodes 21 have opposite polarity, and emit pulse energy. They work together during ablation to achieve bipolar ablation, which can effectively increase the ablation area.

[0132] Although the medical definition of hypertrophic cardiomyopathy is a ventricular septal thickness greater than 15 mm, in practice, patients often have a thickness exceeding 20 mm, and some even have a thickness as thick as 30 mm. Patients with this thickness require deeper insertion. However, on the one hand, after insertion, the transmission of torque is hindered by myocardial tissue, making insertion more difficult the deeper the insertion. On the other hand, the ablation range is limited, and a too deep range may mean that complete ablation may not be achieved. Therefore, by simultaneously inserting at least two ablation catheters 10 into the left / right ventricle for ablation, the ablation area can be effectively expanded and the difficulty of insertion can be reduced.

[0133] Furthermore, while pulse ablation offers improved safety compared to radiofrequency ablation, it also limits the size of the ablation area. To increase the ablation area while maintaining the same equipment, the pulse width / voltage must be increased. These increases, once exceeding thresholds, can significantly induce physiological reactions in patients, such as muscle tremors. The ablation system shown in FIG19 incorporates at least two ablation catheters 10. This allows for simultaneous ablation of the hypertrophic ventricular septum in hypertrophic cardiomyopathy from both sides, achieving superior ablation results without increasing pulse width / voltage. This improves safety while maintaining ablation effectiveness.

[0134] In a preferred embodiment of the present invention, at least one of the two ablation catheters 10 includes a positioning sensor, which 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, which is 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 solution is that, compared to crude estimations of insertion distance and position based on impedance and electrocardiogram waveforms, the position signals transmitted by the positioning sensors, particularly the distance between the two positioning sensors, are more accurate and easier to implement, and can be achieved without the need for any other expensive equipment. Existing ablation catheter position determination requires hospitals to have a three-dimensional mapping system, which costs millions of yuan and is unaffordable for ordinary primary care hospitals, hindering the development of ablation procedures. With easily implementable positioning sensors, insertion and position determination can be completed under the guidance of simple imaging equipment, significantly reducing the basic requirements for surgery and the learning curve for doctors.

[0135] In summary, the present invention provides an ablation catheter, an ablation system including the ablation catheter, and an ablation method. The catheter is fixed in the target tissue by an insertion portion, which facilitates fixing the ablation position and prevents changes during operation. The non-ablation electrode arrangement enables detection of impedance, pacing voltage, etc., and facilitates detection of the position and insertion depth of the ablation catheter without the need for expensive three-dimensional imaging equipment. Furthermore, when the ablation system of the present invention is used, which includes at least two ablation catheters, bipolar ablation can be performed more effectively. The bidirectional insertion of the two ablation catheters avoids excessive insertion of a single catheter, reduces tissue damage, and expands the ablation range. The positioning sensor can accurately detect the position of the ablation catheter at a low cost.

[0136] The embodiments of the present invention are 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. Various changes can be made within the knowledge of ordinary technicians in this field without departing from the purpose of the present invention.

Claims

1. An ablation catheter, characterized in that, It includes a protruding part, an ablation body, a catheter body, and a control handle that are connected in sequence; Among them, the protruding part includes a screwing member that can rotate and drill into and fix to the target tissue under the action of an external force; the ablation body includes an ablation electrode, a connecting member, and a temperature sensor. The ablation electrode has a first end connected to the screwing member, a first cavity disposed opposite to the first end, a second cavity extending from the first cavity towards the first end, and perfusion holes penetrating the circumferential surface of the ablation electrode. The connecting member is disposed in the first cavity. One end of the connecting member close to the catheter body extends out of the first cavity and is connected to the catheter body. The connecting member has a first channel axially penetrating therethrough, and the first channel communicates with the second cavity, the perfusion holes, and the infusion channel in the catheter body. The connecting member and the inner wall of the first cavity form several second channels, and 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 disposed at an interval from the ablation electrode. During ablation, the non-ablation electrode does not contact the target tissue.

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 1, wherein The screwing member is in a three-dimensional spiral shape or a screw shape, and the end far from the ablation body is a tip.

4. The ablation catheter according to claim 3, wherein The pitch of the screwing member gradually decreases from the distal end to the proximal end, and the pitch of the screwing member is 0.25 - 1.5 times the diameter of the screwing member.

5. The ablation catheter according to claim 3, wherein, The diameter of the screwing member gradually decreases from the proximal end to the distal end.

6. The ablation catheter according to claim 1, wherein, The first end of the ablation electrode has a third cavity, and the screwing member is connected in the third cavity.

7. The ablation catheter according to claim 6, wherein The screwing member is fixedly connected in the third cavity, and the length of the screwing member is greater than the axial length of the third cavity.

8. The ablation catheter according to claim 6, wherein The screwing member is telescopically connected in the third cavity, and the length of the screwing member is less than or equal to the axial length of the third cavity.

9. The ablation catheter according to claim 1, wherein, The protruding part further includes an insert. The length of the insert is less than or equal to the length of the screwing member. The insert is sleeved inside the screwing member and does not contact the screwing member.

10. The ablation catheter according to claim 9, wherein, The insert is a hollow structure and has through holes penetrating the circumferential surface of the insert. The proximal end of the insert communicates with the second cavity.

11. The ablation catheter according to claim 1, wherein The perfusion holes are disposed on one side of the second cavity close to the first cavity.

12. The ablation catheter according to claim 1, wherein The perfusion holes are provided in multiple groups, and the multiple groups of perfusion holes are axially spaced apart on the outer circumferential surface of the second cavity along the ablation electrode.

13. The ablation catheter according to claim 12, wherein, Each group of perfusion holes includes multiple perfusion sub-holes, and the multiple perfusion sub-holes are circumferentially spaced apart along the ablation electrode.

14. The ablation catheter according to claim 12, wherein, The projections of two adjacent perfusion holes on a plane perpendicular to the axial direction of the ablation electrode partially overlap.

15. The ablation catheter according to claim 1, characterized in that, The protruding part is conductive and is insulated from the ablation electrode.

16. The ablation catheter according to claim 1, wherein The ablation body further includes a positioning sensor configured to sense the position of the ablation catheter in the target tissue. The temperature sensor and the positioning sensor are respectively located in different second channels.

17. The ablation catheter according to any one of claims 1-16, characterized in that, The ablation catheter further includes a guide member, which includes a connecting portion, a guiding portion, and a guiding hole penetrating through the connecting portion and the guiding portion. The connecting portion is connected to the ablation catheter. The inner wall of the guiding portion is in the shape of a flared mouth with a gradually decreasing diameter from the end far away from the connecting portion to the end close to the connecting portion. The guiding hole communicates with the liner wire channel in the ablation catheter.

18. The ablation catheter according to claim 17, wherein The guide member further includes a holding portion located between the connecting portion and the guiding portion. The guiding hole penetrates through the connecting portion, the holding portion, and the guiding portion.

19. An ablation system, characterized in that, An ablation catheter, an integrated ablation instrument, a perfusion device, and an imaging device according to any one of claims 1-18, wherein the integrated ablation instrument is respectively connected to the ablation catheter, the perfusion device, and the imaging device. The perfusion device is connected to the ablation catheter. The integrated ablation instrument 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 interaction control module, and an ablation control switch. Wherein, 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 feedback it 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 feedback it to the MCU central control module. The ECG signal detection module is used to detect an electrocardiogram signal and feedback it to the MCU central control module. The electrical stimulation / pacing signal module is used to generate and send an electrical stimulation / pacing signal 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 interaction control module, the ablation control switch, the ablation catheter, the perfusion device, and the imaging device, and is used to receive the information of other modules for processing, and feedback and / or display the processed information. The interaction control module is used to display information and receive the control instructions of the user. The ablation control switch is used to control the application of ablation energy to the target tissue.

20. An ablation system, characterized in that, An ablation catheter, an integrated ablation instrument, a perfusion device, and an imaging device according to any one of at least two claims 1-18, wherein the integrated ablation instrument is respectively connected to at least two ablation catheters, the perfusion device, and the imaging device. The perfusion device is respectively connected to at least two ablation catheters. The integrated ablation instrument 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 interaction control module, and an ablation control switch. Wherein, the ablation generation module is used to generate and send ablation energy to each ablation electrode respectively. The temperature detection module is used to receive the signal of each temperature sensor and feedback it 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 feedback it to the MCU central control module; The ECG signal detection module is used to detect the electrocardiogram signal and feedback it to the MCU central control module; The electrical stimulation / pacing signal module is used to generate and send 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 interaction control module, the ablation control switch, at least two of the ablation catheters, the perfusion device and the imaging device, and is used to receive and process the information of other modules, and feedback and / or display the processed information; The interaction control module is used to display information and receive the control instructions of the user; The ablation control switch is used to control the application of ablation energy to the target tissue.

21. The ablation system according to claim 19 or 20, characterized in that, The ablation system further includes a position detection module, and the position detection module receives the signal of the positioning sensor and feedbacks it to the MCU central control module.

22. An ablation method, characterized in that, Using the ablation system according to claim 19, includes the following steps: S1: Puncture the subclavian vein / jugular vein, and send the ablation catheter into the right ventricle through the delivery catheter; S2: Adjust the angles and positions of the delivery catheter and the ablation catheter under the guidance of the imaging device, and monitor the impedance and / or the electrocardiogram waveform in real time. The impedance is the impedance between the ablation electrode and the patient's body surface negative electrode plate and / or the impedance difference between the ablation electrode and the non-ablation electrode; S3: After the delivery catheter reaches the specified position, screw the insertion part into the target tissue. During this period, determine whether the insertion part is screwed in and the depth of screwing in according to the change of the impedance between the ablation electrode and the patient's body surface negative electrode plate and / or the change of the impedance difference between the ablation electrode and the non-ablation electrode. After the ablation electrode reaches the target ablation area, turn on the perfusion device; S4: Adjust the parameters for ablation; S5: After ablation, perform electrical stimulation to check whether the ablation is sufficient; S6: Unscrew; S7: If other points need to be ablated, repeat S2-S6; S8: After all surgeries are completed, remove the catheter from the body.

23. The ablation method according to claim 22, wherein The ablation catheter includes a positioning sensor, and step S2 further includes that the ablation catheter uses magnetoelectric positioning through the positioning sensor to determine the position of the ablation electrode.

24. The ablation method according to claim 22, wherein In step S1, puncture the femoral artery, and send the ablation catheter into the left ventricle through the delivery catheter.

25. The ablation method according to any one of claims 22-24, characterized in that, In step S3, send an electrical signal through the ablation electrode, and judge whether the insertion part is screwed in and the depth of screwing in according to whether the electrical signal can be detected on the body surface and the change of the electrical signal.

26. The ablation method according to any one of claims 22-24, characterized in that, In step S5, the electrical stimulation examination is to apply a pacing voltage electrical signal that gradually increases to the ablated tissue through the ablation electrode. When the applied pacing voltage electrical 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. Then, the completed ablation lesion range is the expected ablation range 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 completing the expected ablation lesion range, and the pacing voltage threshold is proportional to the expected ablation lesion range.

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