Ablation system and ablation method thereof

Abstract

The ablation system comprises ablation forceps, an ablation instrument and an operation part, the ablation forceps comprise a forceps holder assembly, an ablation assembly and an electrical connection assembly, and the forceps holder assembly comprises a far-end forceps holder and a near-end forceps holder which can be close to or away from each other; the ablation assembly comprises a far-end electrode set installed on the far-end forceps holder, a near-end electrode set installed on the near-end forceps holder and electrode marks arranged on the surface of the near-end forceps holder, the far-end electrode set and the near-end electrode set respectively comprise at least one electrode, and each electrode on the near-end forceps holder corresponds to one electrode mark. The ablation method comprises the steps that after target tissue is clamped by the forceps holder assembly, the positions of the electrodes corresponding to the electrodes are judged according to the electrode identifiers, the attaching states of the electrodes are judged according to local impedance data of the electrodes, and then the positions of the ablation forceps are adjusted or an ablation area is arranged. According to the invention, the safety and effectiveness of the operation are improved, the ablation effect is better, and the operation duration is shorter.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and specifically relates to an ablation system and an ablation method thereof. Background Art

[0002] Atrial fibrillation (AF) is a common cardiac arrhythmia, characterized by irregular heartbeat frequency and ineffective atrial contraction. It is one of the causes of stroke, coronary heart disease, heart failure, hypertension and other diseases. In severe cases, it will threaten the patient's life safety.

[0003] Commonly used methods for treating atrial fibrillation in clinical practice include drug therapy, cardiac surgical ablation, intracardiac catheter ablation, etc. Among them, cardiac surgical ablation has a higher success rate and a lower recurrence rate. The use of pulsed ablation forceps in cardiac surgical ablation is an effective treatment for arrhythmias. Different from radiofrequency ablation and cryoablation commonly used in clinical practice, pulsed electric field ablation has good tissue selectivity, can avoid damage to non-target tissues, and more safely and efficiently ablate target tissues around the heart, isolate abnormal electrical signals, and restore heart rhythm to normal.

[0004] During surgical treatment, the pulse ablation forceps need to clamp the target tissue with a certain thickness. The ablation electrode's contact strength and contact position on the target tissue require the surgeon to make real-time and continuous adjustments to ensure thorough ablation and continuity of the ablation position. Therefore, the control of the contact between the ablation electrode and the target tissue will affect the duration and effect of the operation.

[0005] Explanation of relevant terms:

[0006] Atrial fibrillation: Atrial fibrillation (AF) is the most common persistent arrhythmia. The incidence of AF increases with age, and can reach 10% in people over 75 years old. During AF, the frequency of atrial excitation reaches 300 to 600 beats per minute, and the heart rate is often fast and irregular, sometimes up to 100 to 160 beats per minute, which is not only much faster than a normal heartbeat, but also absolutely irregular, and the atrium loses its effective contraction function. The prevalence of AF is also closely related to coronary heart disease, hypertension, heart failure and other diseases.

[0007] Pulse ablation: Pulse field ablation (PFA) is achieved by designing an appropriate pulse electric field and using multiple short-duration, high-voltage electric pulses to release ablation energy, making the ablation process non-thermal ablation (no Joule heat generation), effectively inducing electroporation in myocardial cells, allowing extracellular cations to enter the cells, causing myocardial cells to fragment and die (pulse field ablation is therefore also called irreversible electroporation).

[0008] Radiofrequency ablation: Radiofrequency ablation (RF) is the release of radiofrequency current to kill abnormal myocardial cells at specific locations. Cold saline is used to flush the tip of the catheter during the ablation process. This lowers the temperature of the tip electrode and prevents the temperature of the tissue interface from being too high during high-frequency discharge, thereby improving surgical safety, reducing serious complications such as thrombosis, and alleviating patient pain.

[0009] Pulmonary vein isolation: the mainstay of treatment for atrial fibrillation.

[0010] Local impedance: A method used to assess electrical coupling to tissues where electrical energy is applied to an electrode and when the electrode is close to the target tissue, the reactance between the directly measured electrode and its neighbor is calculated to indicate contact with the target tissue. Summary of the invention

[0011] In view of the above-mentioned problems existing in the prior art, the purpose of the present invention is to provide an ablation system and an ablation method thereof, so that the operator can grasp the position of the ablation electrode and its contact with the target tissue during treatment, adjust the position of the ablation forceps or set the ablation area according to the position and contact of each electrode, and also set the discharge mode, thereby improving the safety and effectiveness of the operation, achieving better ablation effect and shortening the operation time.

[0012] In order to achieve the above object, the technical solution adopted by the present invention is:

[0013] An ablation system includes an ablation forceps, an ablation instrument, and an operating unit. The ablation forceps include a clamp assembly, an ablation assembly, and an electrical connection assembly. The clamp assembly includes a distal clamp and a proximal clamp, and the distal clamp and the proximal clamp can be close to or far away from each other. The ablation assembly includes a distal electrode group installed in the distal clamp, a proximal electrode group installed in the proximal clamp, and an electrode marker set on the surface of the proximal clamp. The distal electrode group and the proximal electrode group respectively include at least one electrode. Each electrode on the proximal clamp corresponds to an electrode marker. The electrode position corresponding to each electrode marker is determined by each electrode marker. Each electrode on the clamp assembly is connected to the electrical connection assembly via a wire, and the electrical connection assembly is connected to the ablation instrument. The ablation instrument provides discharge energy to the ablation assembly and collects local impedance data of each electrode. The power on and off of each electrode is controlled by the operating unit.

[0014] As a further improvement of the above technical solution:

[0015] The ablation system also includes a display interface. The algorithm module built into the ablation instrument determines the electrode adhesion status in real time based on the local impedance data of each electrode collected by the ablation instrument, and displays the adhesion status of each electrode on the display interface. The display interface and the operating unit can be combined into an operating interface that can both display the electrode adhesion status and input control electrode power on and off operation instructions.

[0016] The ablation forceps also include a connecting assembly, a movable rod and a handle assembly. The distal clamp is fixedly connected to the connecting assembly, and the proximal clamp is slidably arranged on the connecting assembly. One end of the movable rod is connected to the proximal clamp and the other end is connected to the handle assembly. The proximal clamp is closer to the handle assembly than the distal clamp.

[0017] Each electrode mark overlaps with the projection of each corresponding electrode on the mounting surface where the electrode mark is located, and the electrode mark faces the handle assembly.

[0018] Both the distal clamp and the proximal clamp are arc-shaped rod-shaped hollow structures or straight rod-shaped hollow structures. The distal clamp and the proximal clamp are arranged in parallel. A side wall of the distal clamp facing the proximal clamp is provided with multiple mounting holes, and the mounting holes are connected to the inside of the distal clamp. The multiple mounting holes are arranged at intervals along the length direction of the distal clamp. A side wall of the proximal clamp facing the distal clamp is also provided with multiple mounting holes, and the mounting holes are connected to the inside of the proximal clamp. The multiple mounting holes are arranged at intervals along the length direction of the proximal clamp. The mounting holes on the distal clamp are used to install the electrodes of the distal electrode group, and the mounting holes on the proximal clamp are used to install the electrodes of the proximal electrode group.

[0019] The connecting assembly includes a distal connecting piece and a connecting tube. The distal connecting piece is formed by removing material from a hollow structure to form a long groove. A slide groove is provided on the concave side of the distal connecting piece. The length direction of the slide groove is consistent with the length direction of the distal connecting piece. The connecting tube is a hollow tubular structure. The distal connecting piece and the connecting tube are coaxially fixedly connected. One end of the connecting tube is coaxially fixedly connected to the distal connecting piece, and the other end is fixedly connected to the handle assembly. One end of the distal clamp is fixedly connected to the distal connecting piece, and the other end is cantilevered. One end of the proximal clamp is slidably arranged on the slide groove, and the other end is cantilevered.

[0020] The movable rod is a hollow rod-shaped structure, located in the connecting assembly, and its length direction is consistent with that of the connecting pipe, and the movable rod can move along the axial direction of the connecting pipe. One end of the proximal clamp slidingly arranged on the sliding groove is fixedly connected to the movable rod.

[0021] The handle assembly includes a handle upper shell, a handle lower shell, a limit assembly, a push rod and a third elastic element. The handle upper shell and the handle lower shell can be covered and clamped with each other to form a structure with an internal cavity. The internal cavity is assumed to be a handle cavity. One end of the connecting assembly away from the clamp assembly is fixedly connected to the handle cavity. One end of the movable rod is connected to the proximal clamp, and the other end extends into the handle cavity and is fixedly connected to the push rod. One end of the push rod is located in the handle cavity and connected to the movable rod, and the other end is located outside the handle cavity. The outer sleeve of the movable rod between the push rod and the connecting assembly is connected with an elastic element assembly. When the push rod pushes the movable rod until the proximal clamp and the distal clamp are in contact, the limit assembly and the limit holes on the push rod are aligned, and the limit assembly is pushed into the limit hole under the elastic force of the third elastic element to prevent the movable rod from moving.

[0022] An ablation method, based on the above-mentioned ablation system, after the clamp assembly clamps the target tissue, first determine the position of each electrode corresponding to it through each electrode marker and determine the adhesion status of each electrode through the local impedance data of each electrode displayed on the display interface, then adjust the position of the ablation forceps or set the ablation area according to the position and adhesion status of each electrode, and set the ablation area by controlling the selected electrode to be powered on or off, and the target tissue area where the powered electrode is located is the selected ablation area.

[0023] The output voltage between electrodes is 500-5000v, and the distance between adjacent electrodes is 1-10mm.

[0024] The beneficial effects of the present invention are:

[0025] (1) The ablation system is used for cardiac surgical ablation treatment, and has high ablation efficiency and good effect.

[0026] (2) The proximal clamp is provided with electrode markers for marking the positions of each electrode. The electrode markers face the handle assembly, i.e., the operator, so that the operator can intuitively, quickly, and accurately know the positions of each electrode. The positions of the electrodes are the positions for ablation. The electrode markers do not occupy additional space of the ablation forceps, do not affect the ablation operation, and do not affect the tissue to be ablated or other normal tissues of the human body.

[0027] (3) Each electrode is independently connected to the electrical connector through a wire, and then independently connected to the ablation device. This allows the operator to subjectively and flexibly select the electrodes to be powered on and off, thereby flexibly and accurately selecting the area and location to be ablated. For example, some obese patients have thick extracardiac fat, and it is inevitable that the ablation electrode will contact the fat when clamping the pulmonary vein. In this case, the operator can avoid ablation in the fat area by selecting the electrodes to be powered on and off.

[0028] (4) The contact status of the electrodes is determined by observing the impedance of each electrode, and the position of the ablation forceps is adjusted or the ablation area is set accordingly.

[0029] (5) During ablation, the position of the electrode can be quickly determined through the electrode identification, and the contact of the electrode can be determined by observing the impedance of each electrode, so that the position of the ablation forceps can be adjusted or the ablation area can be set according to the position and contact of each electrode. The ablation area can be set by selecting the energized electrode. The ablation area can be actively selected in this precise and flexible manner, which improves the safety and effectiveness of the operation, achieves better ablation effects, and shortens the operation time. There is no need to constantly confirm the ablation position and adjust the position of the ablation forceps. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a schematic structural diagram of an embodiment of the present invention.

[0031] Figure 2 It is a schematic diagram of the structure in which the distal clamp and the proximal clamp of the present invention are arc-shaped.

[0032] Figure 3 yes Figure 2 Another perspective structural diagram of .

[0033] Figure 4 It is a schematic diagram of the structure in which the distal clamp and the proximal clamp of the present invention are linear.

[0034] Figure 5 It is a schematic structural diagram of a handle assembly according to an embodiment of the present invention.

[0035] Figure 6 It is a schematic structural diagram of a limit assembly according to an embodiment of the present invention.

[0036] Figure 7 It is a schematic diagram of the limiting hole structure on the push rod according to an embodiment of the present invention. DETAILED DESCRIPTION

[0037] The specific implementation of the present invention is described in detail below in conjunction with the accompanying drawings. It should be understood that the specific implementation described here is only used to illustrate and explain the present invention, and is not used to limit the present invention.

[0038] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below other devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0039] In this specification, "distal end" refers to an end relatively far from the user or an end relatively far from the main body of the device of the present invention (such as the handle assembly). "Proximal end" refers to an end relatively close to the user or an end relatively close to the main body of the device of the present invention (such as the handle assembly).

[0040] An ablation system comprises an ablation forceps, an ablation instrument, an operation unit and a display interface, wherein the ablation forceps is Figures 1 to 7 As shown, it includes a clamp assembly 1, an ablation assembly 2, a connection assembly 3, a movable rod 4, a handle assembly 5, and an electrical connection assembly 6.

[0041] The discharge energy of the ablation system may be pulse energy or radio frequency energy. In other words, the ablation system may perform ablation by pulse energy or radio frequency energy.

[0042] The clamp assembly 1 includes a distal clamp 1-1 and a proximal clamp 1-2, which can be moved closer to or farther from each other to clamp the target tissue to be ablated. The distal clamp 1-1 and the proximal clamp 1-2 are both arc-shaped rod-shaped structures or linear rod-shaped structures. The distal clamp 1-1 and the proximal clamp 1-2 are arranged in parallel.

[0043] In this embodiment, the lengths of the distal clamp 1-1 and the proximal clamp 1-2 are the same, preferably, the lengths of the distal clamp 1-1 and the proximal clamp 1-2 are 50-100 mm. When the distal clamp 1-1 and the proximal clamp 1-2 are arc-shaped, the lengths and arcs of the two are the same, the arcs are 0-5 degrees, and the concave and convex directions of the distal clamp 1-1 and the proximal clamp 1-2 are consistent, that is, the convex side of the distal clamp 1-1 faces the concave side of the proximal clamp 1-2.

[0044] The distal clamp 1-1 and the proximal clamp 1-2 are both connected to the connecting assembly 3 at one end and cantilevered at the other end. Specifically, the distal clamp 1-1 and the proximal clamp 1-2 can be connected to the connecting assembly 3 separately, or the distal clamp 1-1 and the proximal clamp 1-2 can be connected to each other first and then connected to the connecting assembly 3.

[0045] The distal clamp 1-1 and the proximal clamp 1-2 are both hollow structures. Preferably, the cross-sections of the distal clamp 1-1 and the proximal clamp 1-2 are both rectangular. A plurality of mounting holes are provided on a side wall of the distal clamp 1-1 facing the proximal clamp 1-2, and the mounting holes are connected to the inside of the distal clamp 1-1. The plurality of mounting holes are arranged at intervals along the length direction of the distal clamp 1-1. Preferably, the plurality of mounting holes of the distal clamp 1-1 are arranged at equal intervals. Similarly, a plurality of mounting holes are also provided on a side wall of the proximal clamp 1-2 facing the distal clamp 1-1, and the mounting holes are connected to the inside of the proximal clamp 1-2. The plurality of mounting holes are arranged at intervals along the length direction of the proximal clamp 1-2. Preferably, the plurality of mounting holes of the proximal clamp 1-2 are arranged at equal intervals. When the distal clamp 1-1 and the proximal clamp 1-2 move to contact each other, the multiple mounting holes on the distal clamp 1-1 contact and align with the multiple mounting holes on the proximal clamp 1-2. The mounting holes on the distal clamp 1-1 and the proximal clamp 1-2 are used to install the ablation assembly 2.

[0046] The distal clamp 1 - 1 and the proximal clamp 1 - 2 are made of stainless steel, alloy, ceramic or other composite materials.

[0047] The ablation assembly 2 includes a distal electrode group 2-1 installed on the distal clamp 1-1, a proximal electrode group 2-2 installed on the proximal clamp 1-2, and an electrode marker 2-3 provided on the proximal clamp 1-2. The distal electrode group 2-1 is installed on the mounting hole of the distal clamp 1-1, and the proximal electrode group 2-2 is installed on the mounting hole of the proximal clamp 1-2. The distal electrode group 2-1 and the proximal electrode group 2-2 are respectively connected to the electrical connection assembly 6 through wires.

[0048] The distal electrode group 2-1 and the proximal electrode group 2-2 each include at least one electrode, and the electrode shape is circular, square or filamentary, preferably circular. Each electrode is installed on one of the mounting holes, and at most one electrode is installed on each mounting hole. If there are two or more electrodes in the same electrode group, the polarities of adjacent electrodes in the same electrode group are opposite (one positive and one negative), and the shapes of each electrode can be freely combined. The electrodes in the same electrode group are arranged along the length direction of the distal electrode group 2-1 or the proximal electrode group 2-2 and have the same spacing. Obviously, when the clamp assembly 1 clamps the target tissue, the electrode will be close to the target tissue for ablation.

[0049] After being installed in the installation hole, each electrode protrudes from the side wall where it is located, and the height above the side wall surface is 0-1mm. In order to avoid unnecessary mechanical damage to the target tissue caused by the clamp assembly 1 when clamping, it is preferably 0.1-0.5mm.

[0050] Since the clamp assembly 1 is not transparent and the position of the electrode cannot be directly observed, an electrode marker 2-3 is provided. The electrode marker 2-3 is used to mark and indicate the position of the electrode. The operator can directly observe the position of the electrode marker 2-3 to determine the position of the electrode corresponding to it, so as to achieve the effect of assisting ablation. Specifically, the electrode marker 2-3 is provided on the outer surface of the side wall of the proximal clamp 1-2 opposite to the side wall where the electrode is installed. In other words, the electrode marker 2-3 is installed on the outer surface of a side wall of the proximal clamp 1-2 facing the handle assembly 5, as shown in FIG. Figures 2 to 4 As shown. The shape of the electrode marker 2-3 can be the same as the shape of the electrode, such as a circle, a square, a solid dot or a straight line, a curve, etc. Each electrode on the proximal clamp 1-2 corresponds to an electrode marker 2-3, and each electrode marker 2-3 coincides with the projection of each corresponding electrode on the mounting surface where the electrode marker 2-3 is located. During surgery, the surgeon can judge the position of the electrode by directly observing the position of the electrode marker 2-3, and the observed position of the electrode marker 2-3 can be regarded as the position of the corresponding electrode, thereby achieving the effect of assisting ablation. Means for marking the electrode marker 2-3 include laser marking, machining, spraying of composite materials with good biocompatibility, labeling, painting, etc.

[0051] The connection assembly 3 includes a distal connector 3-1 and a connection tube 3-2. The distal connector 3-1 is formed by removing material from a hollow structure, so that the distal connector 3-1 forms a long groove structure, and a slide groove 3-3 is provided on the concave side of the distal connector 3-1, and the length direction of the slide groove 3-3 is consistent with the length direction of the distal connector 3-1. The connection tube 3-2 is a hollow tubular structure, and the distal connector 3-1 and the connection tube 3-2 are coaxially fixedly connected. One end of the connection tube 3-2 is coaxially fixedly connected to the distal connector 3-1, and the other end is fixedly connected to the handle assembly 5.

[0052] One end of the distal clamp 1-1 is fixedly connected to the distal connector 3-1, and the other end is cantilevered. One end of the proximal clamp 1-2 is slidably mounted on the slide groove 3-3, and the other end is cantilevered. Preferably, a protrusion is provided on the proximal clamp 1-2, which can slide in the slide groove 3-3. As another embodiment, the distal connector 3-1 and the distal clamp 1-1 are fixedly integrated, and the proximal clamp 1-2 is slidably mounted on the distal connector 3-1 and then connected to the connecting tube 3-2 as a whole.

[0053] The movable rod 4 is a hollow rod-shaped structure, and is located in the connecting assembly 3. The length direction of the movable rod 4 is consistent with the length direction of the connecting tube 3-2, and the movable rod 4 can move along the axial direction of the connecting tube 3-2. One end of the proximal clamp 1-2 that slides on the slide groove 3-3 is fixedly connected to the movable rod 4.

[0054] As can be seen from the above, in this embodiment, the distal clamp 1-1 is a fixed clamp, and the proximal clamp 1-2 is a movable clamp. The proximal clamp 1-2 is closer to the handle assembly 5 than the distal clamp 1-1.

[0055] In this embodiment, the distal connecting piece 3 - 1 , the connecting tube 3 - 2 , and the movable rod 4 are made of stainless steel, alloy, or other composite materials.

[0056] In this embodiment, the cross section of the movable rod 4 is rectangular or circular.

[0057] Handle assembly 5 Figure 5 As shown, it includes a handle upper shell 5-1, a handle lower shell 5-2, a limit assembly 5-3, a push rod 5-4, an elastic element assembly and a third elastic element 5-9. The elastic element assembly includes a first elastic element 5-5, a pin 5-6, a connecting block 5-7, and a second elastic element 5-8.

[0058] The handle upper shell 5-1 and the handle lower shell 5-2 can be covered and snapped together to form a structure with an internal cavity. The internal cavity is assumed to be a handle cavity. The covered structure is L-shaped, which is convenient for human hand holding. One end of the connecting tube 3-2 is fixedly connected to the handle cavity, and the other end is fixedly connected to the distal connecting piece 3-1. One end of the movable rod 4 is connected to the proximal clamp 1-2, and the other end is extended out of the connecting tube 3-2 and fixedly connected to the push rod 5-4. One end of the movable rod 4 extending out of the connecting tube 3-2 is located in the handle cavity, one end of the push rod 5-4 is located in the handle cavity and connected to the movable rod 4, and the other end is located outside the handle cavity to facilitate manual operation of the push rod 5-4. When a person manually pushes the push rod 5-4, the push rod 5-4 drives the movable rod 4 to move synchronously.

[0059] The movable rod 4 between the connecting tube 3-2 and the push rod 5-4 is connected with a first elastic element 5-5, a second elastic element 5-8 and a connecting block 5-7. The connecting block 5-7 is sleeved outside the movable rod 4 and can move along the movable rod 4. In order to make the movement of the connecting block 5-7 more stable and stable, a guide groove is provided on the outer surface of one end of the movable rod 4, and the length direction of the guide groove is consistent with the length direction of the movable rod 4. The pin 5-6 passes through the side wall of the connecting block 5-7 and then slides on the guide groove of the movable rod 4. The first elastic element 5-5 is located between the connecting block 5-7 and the connecting tube 3-2, one end of the first elastic element 5-5 is fixedly connected to the connecting tube 3-2 or the inner wall of the handle cavity, and the other end is fixedly connected to the connecting block 5-7. The second elastic element 5-8 is located between the connecting block 5-7 and the push rod 5-4, one end of the second elastic element 5-8 is fixedly connected to the push rod 5-4, and the other end is fixedly connected to the connecting block 5-7.

[0060] In this embodiment, the first elastic element 5-5 and the second elastic element 5-8 are both springs, the first elastic element 5-5 is a thick spring, and the second elastic element 5-8 is a thin spring. In other words, the diameter of the metal wire constituting the first elastic element 5-5 is greater than the diameter of the metal wire constituting the second elastic element 5-8.

[0061] Furthermore, in order to lock the proximal clamp 1-2, a limit assembly 5-3 and a third elastic element 5-9 are provided. Figure 6 As shown, it includes a key 5-3-1, a connector 5-3-2 and a limit block 5-3-3 connected in sequence along a direction, and the direction is assumed to be the length direction of the limit assembly 5-3. The connector 5-3-2 is thinner than the key 5-3-1 and the limit block 5-3-3. In other words, the width of the connector 5-3-2 is smaller than the width of the limit block 5-3-3 and the key 5-3-1. The width refers to the size of the corresponding component in the direction perpendicular to the length of the limit assembly 5-3. The push rod 5-4 is provided with a limit hole 5-4-1 which is a through hole, as shown in FIG. Figure 7 As shown, the limiting hole 5-4-1 is divided into a blocking portion 5-4-11 and a passing portion 5-4-12 along its length direction, the blocking portion 5-4-11 and the passing portion 5-4-12 are connected, the blocking portion 5-4-11 is closer to the movable rod 4 than the passing portion 5-4-12, the length direction of the limiting hole 5-4-1 is consistent with the length direction of the movable rod 4, the width of the blocking portion 5-4-11 is smaller than the width of the passing portion 5-4-12, and the width direction of the blocking portion 5-4-11 or the passing portion 5-4-12 is perpendicular to the length direction of the limiting hole 5-4-1. The connecting piece 5-3-2 can pass through the blocking portion 5-4-11 and the passing portion 5-4-12, and the limiting block 5-3-3 can pass through the passing portion 5-4-12 but cannot pass through the blocking portion 5-4-11.

[0062] The limit assembly 5-3 is movably mounted on the handle upper shell 5-1 and the handle lower shell 5-2. Specifically, the length direction of the limit assembly 5-3 is perpendicular to the length direction of the movable rod 4. The button 5-3-1 is located on the handle upper shell 5-1 and outside the handle cavity for easy manual operation. The connecting piece 5-3-2 passes through the limit hole 5-4-1. The limit block 5-3-3 is connected to one end of the third elastic element 5-9, and the other end of the third elastic element 5-9 is connected to the inner wall of the handle lower shell 5-2. The third elastic element 5-9 is in a compressed state.

[0063] Based on the above structure, when a person presses the button 5-3-1, the limiting component 5-3 moves toward the direction close to the third elastic element 5-9, and the third elastic element 5-9 is further compressed.

[0064] In this embodiment, the third elastic element 5 - 9 is a spring.

[0065] When the ablation forceps is in the initial state, it is not acted upon by external force, and the proximal clamp 1-2 is at the farthest position from the distal clamp 1-1. The button 5-3-1 and the limit block 5-3-3 are respectively located on both sides of the push rod 5-4, the connecting member 5-3-2 passes through the blocking portion 5-4-11 and is located at the end of the blocking portion 5-4-11 close to the movable rod 4, the limit block 5-3-3 is located between the push rod 5-4 and the lower shell 5-2 of the handle, and the third elastic element 5-9 is compressed.

[0066] Based on the above structure, the clamping, locking and resetting functions can be realized by operating the handle assembly 5. The specific implementation method is as follows:

[0067] Clamping function: When the push rod 5-4 is pushed, the distance between the push rod 5-4 and the connecting tube 3-2 decreases, the first elastic element 5-5 and the second elastic element 5-8 are compressed, the push rod 5-4 drives the movable rod 4, the movable rod 4 drives the proximal clamp 1-2 to move, and the proximal clamp 1-2 moves toward the direction close to the distal clamp 1-1 until the two are in contact to clamp the tissue to be ablated.

[0068] Locking function: When the push rod 5-4 is pushed, the limit assembly 5-3 and the push rod 5-4 move relative to each other, and the moving direction is that the distance between the limit assembly 5-3 and the through portion 5-4-12 is reduced. When the proximal clamp 1-2 is in close contact with the distal clamp 1-1, the through portion 5-4-12 and the limit block 5-3-3 are aligned. Under the elastic force of the third elastic element 5-9, the limit assembly 5-3 moves in the direction away from the lower shell 5-2 of the handle, and the limit block 5-3-3 is stuck in the through portion 5-4-12. Under the obstruction of the limit block 5-3-3, the push rod 5-4 cannot move further, and thus the proximal clamp 1-2 cannot move further. In this way, the push rod 5-4 and the distance between the proximal clamp 1-2 and the distal clamp 1-1 are locked, and the operator can complete the ablation operation without having to force the push rod 5-4 to be fixed.

[0069] Reset function: After the ablation operation is completed, the person manually presses the button 5-3-1, the third elastic element 5-9 is compressed, the limit assembly 5-3 moves toward the direction close to the handle lower shell 5-2, and the limit block 5-3-3 withdraws from the through portion 5-4-12 and returns to between the through portion 5-4-12 and the handle lower shell 5-2. The push rod 5-4 is no longer stuck, the first elastic element 5-5 and the second elastic element 5-8 rebound from the compressed state, pushing the push rod 5-4 back to the initial position, driving the movable rod 4 and the proximal clamp 1-2 to move away from the distal clamp 1-1 until reaching the farthest distance from the distal clamp 1-1.

[0070] The electrical connection assembly 6 includes a power cord 6-1 and an electrical connector 6-2. The power cord 6-1 contains wires drawn from the distal clamp 1-1 and the proximal clamp 1-2, and the wires pass through the movable rod 4 or the gap between the movable rod 4 and the connecting tube 3-2. The outer sheath of the power cord is rubber, silicone, polymer material or other soft composite materials, and has good insulation and flame retardancy. One end of the electrical connector 6-2 is welded to the wire in the power cord, and the other end is connected to the ablation device, which provides discharge energy to the electrode to achieve ablation and auxiliary ablation functions. The ablation device can adopt a pulse ablation device in the prior art.

[0071] Inside the distal clamp 1-1 and the proximal clamp 1-2, each electrode of the distal electrode group 2-1 and each electrode of the proximal electrode group 2-2 are welded to different wires. The wires connecting the electrodes of the distal electrode group 2-1 pass through the distal clamp 1-1 and then pass through the distal connector 3-1 and the movable rod 4 in turn, and then are led out from the tail of the handle assembly 5 and welded to the electrical connector 6-2. Similarly, the wires connecting the electrodes of the proximal electrode group 2-2 pass through the proximal clamp 1-2 and then enter the connector 3-1. As another embodiment, the electrical connector 6-2 can be directly installed on the handle assembly 5 and connected to the wires in the handle assembly 5, without being connected through the power cord 6-1.

[0072] As described above, each electrode is connected to the electrical connector 6-2 via a wire, and each electrode does not affect each other, which facilitates the individual control of each electrode during the ablation operation.

[0073] The operating unit and the display interface can be combined into one operating interface, which can display parameter information and input operating instructions. First of all, the display interface is the operating interface port of the ablation instrument. When the ablation forceps is connected to the ablation instrument, the display interface will automatically identify the ablation forceps model and draw it on the display interface. Secondly, the electrode part of the drawn catheter can be clearly observed, and the different colors of the electrode display represent the state of adhesion. Finally, the display interface can operate the electrode of the catheter to achieve the operating instructions of power on or off. In summary, for example, if the electrode is displayed as attached but the operator does not want it to be powered on, the power off effect can be achieved by clicking on the electrode.

[0074] In the ablation system, the local impedance display is used to determine whether the electrode is attached to the tissue to be ablated. After the ablation forceps is connected to the ablation instrument, each electrode on the ablation forceps will collect local impedance data through the ablation instrument. All local impedance data will be used by the built-in algorithm module of the ablation instrument to determine the electrode attachment status in real time, and the electrode color will be rendered on the operation interface to prompt the operator of the current attachment status of each electrode, such as "not attached", "attached", "semi-attached", etc., to achieve the purpose of auxiliary ablation. After the ablation instrument is connected to the ablation forceps, it will automatically identify the ablation forceps model and display information including but not limited to the ablation forceps features, electrode number, electrode shape, electrode status, etc. on the operation interface. The operator can set each electrode on the operation interface and independently determine the ablationable area to achieve the purpose of auxiliary ablation. The operator can independently select the ablation mode or discharge mode on the operation interface, which is flexibly applicable to different usage scenarios to achieve the auxiliary ablation effect. Specifically, a chip is built into the handle assembly 5 to record the number of the ablation forceps currently in use. The chip is connected to an external ablation instrument through an electrical connector 6-2. After the ablation forceps is connected to the ablation instrument, the ablation instrument automatically reads the number in the chip and matches the corresponding ablation forceps features in the built-in ablation forceps database, such as electrode size, ablation forceps shape, and corresponding ablation energy. After the matching is completed, the shape and electrode of the ablation forceps will be drawn on the display interface. The operator can click on the electrode displayed in the interface to power on or off the electrode, independently determine the electrode that can participate in the discharge, and control the ablation area. The electrodes that can participate in the discharge will respectively detect the local impedance data in real time and feed it back to the abutment algorithm module in the ablation instrument. The local impedance data is calculated by the abutment algorithm module. The abutment state of the electrode is then fed back to the display interface by rendering the electrode. In other words, in addition to the electrode logo designed on the ablation forceps, the operator can also judge the degree of abutment by the different renderings of the electrode on the display interface.

[0075] From the above, the ablation method based on the ablation system is: after the clamp assembly 1 clamps the target tissue, first determine the position of each electrode corresponding to it through each electrode mark 2-3 and determine the contact state of each electrode through the local impedance data of each electrode displayed on the display interface, and then adjust the position of the ablation clamp or set the ablation area according to the position and contact state of each electrode, and set the ablation area by selecting the energized electrode, and the target tissue area where the energized electrode is located is the selected ablation area. It should be noted that the operator adjusts the position of the ablation clamp manually based on clinical experience and the specific conditions of the patient.

[0076] Preferably, the operation interface can be provided on the handle assembly 5 or can be provided in a state separated from the ablation forceps.

[0077] In this embodiment, the output voltage between electrodes is 500-5000V, preferably 1000-2600V.

[0078] For circular or square electrodes, the diameter or side length of a single electrode is 0.5-5 mm. Further, when pulse energy is used for ablation energy, the diameter or side length of the electrode is preferably 1.5-3 mm.

[0079] The spacing between adjacent electrodes is 1-10 mm. Furthermore, when pulse energy is used for ablation, in order to adapt to different voltage requirements of pulse ablation, the preferred spacing is 2-5 mm:

[0080] When the output voltage is below 1400V, the preferred electrode spacing is 2mm;

[0081] When the output voltage is 1400V-1800V, the preferred electrode spacing is 3mm;

[0082] When the output voltage is 1800V-2200V, the preferred electrode spacing is 4mm;

[0083] When the output voltage is 2200V-2600V, the preferred electrode spacing is 5mm.

[0084] Finally, it is necessary to explain here that the above embodiments are only used to further illustrate the technical solution of the present invention in detail and cannot be understood as limiting the scope of protection of the present invention. Some non-essential improvements and adjustments made by technicians in this field based on the above content of the present invention all fall within the scope of protection of the present invention.

Claims

1. An ablation system, characterized in that: The invention comprises an ablation forceps, an ablation apparatus, and an operating unit. The ablation forceps comprises a clamp assembly (1), an ablation assembly (2), and an electrical connection assembly (6). The clamp assembly (1) comprises a distal clamp (1-1) and a proximal clamp (1-2). The distal clamp (1-1) and the proximal clamp (1-2) can be moved closer to or farther from each other. The ablation assembly (2) comprises a distal electrode group (2-1) mounted on the distal clamp (1-1), a proximal electrode group (2-2) mounted on the proximal clamp (1-2), and an electrode marker (2-1) disposed on the surface of the proximal clamp (1-2). -3), the distal electrode group (2-1) and the proximal electrode group (2-2) each include at least one electrode, each electrode on the proximal clamp (1-2) corresponds to an electrode identifier (2-3), and the electrode position corresponding to each electrode identifier (2-3) is determined, and each electrode on the clamp assembly (1) is connected to an electrical connection assembly (6) through a wire, and the electrical connection assembly (6) is connected to an ablation device, and the ablation device provides discharge energy to the ablation assembly (2), collects local impedance data of each electrode, and controls the power on and off of each electrode through an operating unit.

2. The ablation system according to claim 1, characterized in that: The ablation system also includes a display interface. The algorithm module built into the ablation instrument determines the electrode adhesion status in real time based on the local impedance data of each electrode collected by the ablation instrument, and displays the adhesion status of each electrode on the display interface. The display interface and the operating unit can be combined into an operating interface that can both display the electrode adhesion status and input control electrode power on and off operation instructions.

3. The ablation system according to claim 1, characterized in that: The ablation forceps also include a connecting component (3), a movable rod (4) and a handle component (5); the distal clamp (1-1) and the connecting component (3) are fixedly connected, the proximal clamp (1-2) is slidably arranged on the connecting component (3), one end of the movable rod (4) is connected to the proximal clamp (1-2), and the other end is connected to the handle component (5); the proximal clamp (1-2) is closer to the handle component (5) than the distal clamp (1-1).

4. The ablation system according to claim 3, characterized in that: Each electrode mark (2-3) overlaps with the projection of each corresponding electrode on the mounting surface where the electrode mark (2-3) is located, and the electrode mark (2-3) faces the handle assembly (5).

5. The ablation system according to claim 3, characterized in that: The distal clamp (1-1) and the proximal clamp (1-2) are both arc-shaped rod-shaped hollow structures or linear rod-shaped hollow structures. The distal clamp (1-1) and the proximal clamp (1-2) are arranged in parallel. A plurality of mounting holes are provided on a side wall of the distal clamp (1-1) facing the proximal clamp (1-2). The mounting holes are connected to the inside of the distal clamp (1-1). The plurality of mounting holes are arranged at intervals along the length direction of the distal clamp (1-1). A plurality of mounting holes are also provided on a side wall of the proximal clamp (1-2) facing the distal clamp (1-1). The mounting holes are connected to the inside of the proximal clamp (1-2). The plurality of mounting holes are arranged at intervals along the length direction of the proximal clamp (1-2). The mounting holes on the distal clamp (1-1) are used to mount electrodes of the distal electrode group (2-1), and the mounting holes on the proximal clamp (1-2) are used to mount electrodes of the proximal electrode group (2-2).

6. The ablation system according to claim 3, characterized in that: The connection assembly (3) comprises a distal connection piece (3-1) and a connection tube (3-2). The distal connection piece (3-1) is a structure with a long groove formed by removing material from a hollow structure. A slide groove (3-3) is provided on the inner concave side of the distal connection piece (3-1). The length direction of the slide groove (3-3) is consistent with the length direction of the distal connection piece (3-1). The connection tube (3-2) is a hollow tubular structure. The distal connection piece (3-1) and the connection tube (3-2) are coaxially fixedly connected. One end of the connection tube (3-2) is coaxially fixedly connected to the distal connection piece (3-1) and the other end is fixedly connected to the handle assembly (5). One end of the distal clamp (1-1) is fixedly connected to the distal connection piece (3-1) and the other end is cantilevered. One end of the proximal clamp (1-2) is slidably arranged on the slide groove (3-3) and the other end is cantilevered.

7. The ablation system according to claim 6, characterized in that: The movable rod (4) is a hollow rod-shaped structure. The movable rod (4) is located in the connecting assembly (3). The length direction of the movable rod (4) is consistent with the length direction of the connecting tube (3-2). The movable rod (4) can move along the axial direction of the connecting tube (3-2). One end of the proximal clamp (1-2) that is slidably arranged on the slide groove (3-3) is fixedly connected to the movable rod (4).

8. The ablation system according to claim 3, characterized in that: The handle assembly (5) comprises an upper handle shell (5-1), a lower handle shell (5-2), a limit assembly (5-3), a push rod (5-4) and a third elastic element (5-9). The upper handle shell (5-1) and the lower handle shell (5-2) can be covered and clamped with each other to form a structure with an internal cavity. The internal cavity is assumed to be a handle cavity. One end of the connecting assembly (3) away from the clamp assembly (1) is fixedly connected to the handle cavity. One end of the movable rod (4) is connected to the proximal clamp (1-2), and the other end extends into the handle cavity and is fixedly connected to the push rod (5-4). The push rod (5-4) One end of the push rod (5-4) is located in the handle cavity and connected to the movable rod (4), and the other end is located outside the handle cavity. The movable rod (4) between the push rod (5-4) and the connecting assembly (3) is connected to an elastic element assembly. When the push rod (5-4) pushes the movable rod (4) until the proximal clamp (1-2) and the distal clamp (1-1) are in contact, the limiting assembly (5-3) and the limiting hole (5-4-1) on the push rod (5-4) are aligned, and the limiting assembly (5-3) is pushed into the limiting hole (5-4-1) under the elastic force of the third elastic element (5-9) to prevent the movable rod (4) from moving.

9. An ablation method, based on the ablation system according to any one of claims 1 to 8, characterized in that: After the clamp assembly (1) clamps the target tissue, the position of each electrode corresponding to it is first determined through each electrode identifier (2-3) and the contact state of each electrode is determined through the local impedance data of each electrode displayed on the display interface. Then, the position of the ablation forceps is adjusted or the ablation area is set according to the position and contact state of each electrode. The ablation area is set by controlling the selected electrode to be powered on or off. The target tissue area where the powered electrode is located is the selected ablation area.

10. The ablation method according to claim 9, characterized in that: The output voltage between electrodes is 500-5000v, and the distance between adjacent electrodes is 1-10mm.

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