Ablation devices and radiofrequency ablation equipment

Abstract

The application provides an ablation device and a radio frequency ablation equipment, the ablation device comprises a first electrode assembly and a second electrode assembly, the first electrode assembly comprises a first electrode tip, and the first electrode tip has a first electrode; the second electrode assembly comprises a second electrode tip, and the second electrode tip has a second electrode; wherein the first electrode and the second electrode are oppositely arranged to ablate the tissue to be ablated located between the first electrode and the second electrode through the first electrode and the second electrode. The ablation device can solve the problem that the ablation effect of the ablation device in the prior art is not ideal.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an ablation device and a radiofrequency ablation equipment. Background Art

[0002] Ablation is a common measure for treating atrial fibrillation. Its principle is to create one or more ablation lines in the heart tissue, causing tissue necrosis and cutting off abnormal electrical signal conduction for the treatment of atrial fibrillation.

[0003] Current ablation treatments are divided into surgical ablation and internal medicine interventional ablation. The characteristics of surgical ablation are excellent efficacy and low postoperative recurrence rate, but its obvious disadvantage is greater trauma and slow postoperative recovery. Internal medicine interventional ablation is favored by more and more patients because of its low trauma and quick recovery. However, internal medicine ablation is a point-like ablation, and its biggest disadvantage is that it is difficult to form a complete ablation line; and the ablation is unilateral and adheres to the wall, with a limited ablation depth, making it difficult to ensure complete dehydration and denaturation of the tissue from the inside out. If the ablation power is low during surgery, the ablation will not be thorough, while if the power is high, it is difficult to control, and there are cases of excessive tissue necrosis or even burn-through and leaking. Therefore, the success rate of internal medicine interventional ablation is much lower than that of surgery. Summary of the Invention

[0004] The main purpose of the present invention is to provide an ablation device and a radiofrequency ablation equipment to solve the problems of large surgical ablation trauma, slow postoperative recovery, limited angle of use, and inconvenient operation; to solve the problem that the current internal medicine interventional ablation energy is constant and the output power cannot be adjusted in time according to the ablation effect, resulting in overburning or non-penetrating the wall; to solve the problem that the current internal and external surgical ablation equipment requires additional equipment for mapping after ablation, which is cumbersome to operate.

[0005] In order to achieve the above-mentioned purpose, according to one aspect of the present invention, an ablation device is provided, which includes: a first electrode assembly, the first electrode assembly includes a first electrode end head, the first electrode end head has a first electrode; a second electrode assembly, the second electrode assembly includes a second electrode end head, the second electrode end head has a second electrode; wherein the first electrode and the second electrode are arranged relative to each other so as to ablate the tissue to be ablated located between the first electrode and the second electrode through the first electrode and the second electrode.

[0006] Furthermore, the ablation device further includes an ablation circuit, and the first electrode and the second electrode are both arranged on the ablation circuit, so as to perform ablation by adjusting the radio frequency energy between the first electrode and the second electrode by testing the impedance between the first electrode and the second electrode.

[0007] Furthermore, there are multiple first electrodes and multiple second electrodes, and the multiple first electrodes and the multiple second electrodes are arranged in coordination with each other.

[0008] Furthermore, the first electrode tip and the second electrode tip are both in a bar shape, the plurality of first electrodes are arranged at intervals along the extension direction of the first electrode tip, and the plurality of second electrodes are arranged at intervals along the extension direction of the second electrode tip.

[0009] Furthermore, the number of the first electrodes and the number of the second electrodes are 2 to 10.

[0010] Furthermore, the first electrode tip includes a positioning member, and the first electrode tip is positioned on the epicardium through the positioning member.

[0011] Furthermore, the first electrode terminal is in a bar shape, and there are multiple positioning members, which are arranged along the extension direction of the first electrode terminal.

[0012] Furthermore, the first electrode tip includes a first protective sheath, and at least a portion of the first electrode is arranged within the first protective sheath; there are multiple positioning members, and the multiple positioning members are arranged in pairs, and the two positioning members in the pair are arranged on opposite sides of the first protective sheath; and / or, multiple positioning members are arranged on one side of the first protective sheath.

[0013] Furthermore, the first protective sheath is made of a flexible material and can be rotated at any angle, thus solving the problem of angle limitations of current surgical ablation instrument products.

[0014] Furthermore, the first electrode has an electrode surface disposed toward the tissue to be ablated, and the first protective sheath has a protective sheath surface disposed toward the tissue to be ablated; wherein the electrode surface is located on a side of the protective sheath surface close to the tissue to be ablated.

[0015] Furthermore, there are multiple first electrodes, and the multiple first electrodes are arranged at intervals along the extension direction of the first electrode tip; and the minimum distances between the electrode surfaces of the multiple first electrodes and the protective sheath surface are all the same.

[0016] Furthermore, both the electrode surface and the protective sheath surface are planes.

[0017] Furthermore, the positioning member is a suction cup structure.

[0018] Furthermore, the first electrode end includes a first protective sheath, and at least a portion of the first electrode is arranged in the first protective sheath; there are multiple first electrodes, and the multiple first electrodes are arranged at intervals along the extension direction of the first electrode end; at least one of the multiple first electrodes is provided with a cooling hole for circulating a cooling fluid; and / or, a cooling pipe for circulating a cooling fluid is provided in the first protective sheath.

[0019] Furthermore, at least one of the plurality of first electrodes is provided with 1 to 4 cooling holes.

[0020] Furthermore, the first electrode terminal includes a first magnetic component, and the second electrode terminal includes a second magnetic component. The first magnetic component and the second magnetic component cooperate with each other to relatively fix the first electrode terminal and the second electrode terminal.

[0021] Furthermore, there are multiple first magnetic members and multiple second magnetic members, the first electrode end and the second electrode end are both bar-shaped, the multiple first magnetic members are arranged at intervals along the extension direction of the first electrode end, and the multiple second magnetic members are arranged at intervals along the extension direction of the second electrode end.

[0022] Furthermore, there are multiple first electrodes and multiple second electrodes, the multiple first magnetic members are arranged alternately with the multiple first electrodes, and the multiple second magnetic members are arranged alternately with the multiple second electrodes.

[0023] Furthermore, adjacent first electrodes are insulated from the first magnetic member, and adjacent second electrodes are insulated from the second magnetic member.

[0024] Furthermore, the relative surfaces between adjacent first electrodes and first magnetic parts are sprayed with insulating paint, or an insulating partition is provided between adjacent first electrodes and first magnetic parts; the relative surfaces between adjacent second electrodes and second magnetic parts are sprayed with insulating paint, or an insulating partition is provided between adjacent second electrodes and second magnetic parts.

[0025] Furthermore, outer surfaces of the first magnetic component and the second magnetic component are both covered with an insulating layer.

[0026] Furthermore, the first electrode, the first magnetic member connection, the second electrode connection and the second magnetic member are all connected to independent energized circuits for individual control.

[0027] Furthermore, there are multiple first electrodes, and the power-carrying circuits of two first electrodes are independently set to form a mapping electrode pair, so as to use the power-carrying circuit to detect the electrical signal transmission status of the tissue to be ablated after ablation; and / or, there are multiple second electrodes, and the power-carrying circuits of two second electrodes are independently set to form a mapping electrode pair, so as to use the power-carrying circuit to detect the electrical signal transmission status of the tissue to be ablated after ablation; and / or, the power-carrying circuits of the first electrode and the second electrode are independently set to form a mapping electrode pair, so as to use the power-carrying circuit to detect the electrical signal transmission status of the tissue to be ablated after ablation.

[0028] Furthermore, there are multiple first electrode tips and multiple second electrode tips.

[0029] Furthermore, the second electrode tip includes a second protective sheath, and the second electrode is arranged on the second protective sheath; the second electrode is made of a metal material, and the metal material includes at least one of the following materials: platinum, platinum-iron alloy, tantalum, and gold-plated beryllium bronze; and / or, the second protective sheath is made of a developing material, and the components of the developing material include barium sulfate.

[0030] Furthermore, the second electrodes are spaced apart along the extension direction of the second protective sheath, are sleeved on the second protective sheath, and the surface of the electrodes is higher than the surface of the second protective sheath.

[0031] Furthermore, the first electrode tip includes a first protective sheath, and shielding side ridges are provided on opposite sides of the first protective sheath.

[0032] According to another aspect of the present invention, a radiofrequency ablation device is provided, which includes a radiofrequency host and the above-mentioned ablation device, wherein the ablation device is connected to the radiofrequency host.

[0033] Applying the technical solution of the present invention, the ablation device includes a first electrode assembly and a second electrode assembly, the first electrode assembly includes a first electrode tip having a first electrode, the second electrode assembly includes a second electrode tip having a second electrode, and the first electrode and the second electrode are arranged relative to each other so as to ablate the tissue to be ablated located between the first electrode and the second electrode through the first electrode and the second electrode. In specific use, the first electrode assembly and the second electrode assembly are used as epicardial electrodes and endocardial electrodes respectively, so that the first electrode assembly and the second electrode assembly act on the epicardium and the endocardium respectively, so as to achieve simultaneous ablation of the epicardium and the endocardium, thereby achieving a good ablation effect; it can be seen that the use of this ablation device can solve the problem of unsatisfactory ablation effect of the ablation device in the prior art. In addition, the first electrode assembly can be used independently to act on the epicardium to achieve an ablation effect, and the second electrode assembly can be used independently to act on the endocardium to achieve an ablation effect.

[0034] Whether performing endocardial ablation, epicardial ablation, or simultaneous endocardial and epicardial ablation, a single electrode assembly or coordinated electrode assemblies can perform timely mapping and monitor the ablation effect, solving the current problem that post-ablation mapping still requires the use of external instruments and is point-based mapping, thereby improving the surgical ablation effect.

[0035] In addition, the ablation device in the present application can realize hybrid internal and surgical ablation. This technology has low trauma and solves the problem of large trauma and slow recovery of surgical ablation in the existing technology. At the same time, it can simultaneously ablate the epicardium and endocardium, and adjust the output power by testing the actual impedance between tissues. It is accurate and safe, and when the impedance reaches a certain resistance value, the machine alarm indicates that the ablation is completed, avoiding excessive ablation. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The accompanying drawings, which constitute part of this application, are intended to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are intended to explain the present invention and do not constitute an undue limitation of the present invention. In the accompanying drawings:

[0037] Figure 1A schematic structural diagram showing a state of a first embodiment of a first electrode assembly of an ablation device according to an optional embodiment of the present invention;

[0038] Figure 2 A schematic structural diagram showing another state of a first embodiment of a first electrode assembly of an ablation device according to an optional embodiment of the present invention is shown;

[0039] Figure 3 Shown Figure 1 A schematic diagram of the internal structure of the first electrode tip of the first electrode assembly of the ablation device;

[0040] Figure 4 Shown Figure 3 A cross-sectional view of a first electrode tip of a first electrode assembly of an ablation device;

[0041] Figure 5 Shown Figure 1 A schematic structural diagram of the shielding side eaves of the first electrode assembly of the ablation device;

[0042] Figure 6 Shown Figure 1 A cross-sectional view of another embodiment of a first electrode tip of a first electrode assembly of an ablation device;

[0043] Figure 7 A schematic structural diagram of a first embodiment of a second electrode assembly of an optional ablation device according to the present invention is shown;

[0044] Figure 8 Shown Figure 7 A partial enlarged view of the second electrode assembly of the ablation device;

[0045] Figure 9 Shown Figure 8 An enlarged view of part A of the second electrode assembly of the ablation device;

[0046] Figure 10 A schematic structural diagram of a radio frequency host of an optional radio frequency ablation device according to the present invention is shown;

[0047] Figure 11 It shows an assembly diagram between a radio frequency main unit and an ablation device of an optional radio frequency ablation device according to the present invention;

[0048] Figure 12 A schematic diagram showing the principle of the ablation device of the present invention when ablating tissue to be ablated;

[0049] Figure 13 A diagram showing the coordination between the first electrode and the second electrode of an embodiment of the ablation device of the present invention and the tissue to be ablated;

[0050] Figure 14 An ablation principle diagram showing one state of the ablation device of the present invention;

[0051] Figure 15 A diagram showing the ablation principle of the ablation device of the present invention in another state;

[0052] Figure 16 A schematic diagram showing the wiring between the radio frequency main unit and the first electrode assembly and the second electrode assembly of the radio frequency ablation device of the present invention is shown;

[0053] Figure 17 A schematic structural diagram of a second embodiment of the first electrode assembly of the ablation device of the present invention is shown;

[0054] Figure 18 A schematic structural diagram of a second embodiment of a second electrode assembly of an ablation device according to the present invention is shown;

[0055] Figure 19 A diagram showing the coordination between the first electrode and the second electrode of another embodiment of the ablation device of the present invention and the tissue to be ablated is shown.

[0056] The above drawings include the following reference numerals:

[0057] 100. A first electrode assembly;

[0058] 110, first electrode tip; 111, first electrode; 1110, electrode surface; 112, first magnetic member; 113, first protective sheath; 1130, protective sheath surface; 114, cooling hole; 115, shielding side eaves;

[0059] 117, positioning member; 1171, suction inner wall; 1172, suction outer wall; 1173, suction cavity;

[0060] 1174, first suction port; 1175, second suction port; 1176, air flow channel;

[0061] 120. Wire laying trough;

[0062] 200. Second electrode assembly;

[0063] 210, second electrode tip; 211, second electrode; 212, second magnetic member; 213, developing member; 214, second protective sheath;

[0064] 310. RF host; 311. Ablation interface; 312. Electromagnetic interface; 313. Display screen; 320. Ablation circuit; 330. Ablation range; 340. Tissue to be ablated. DETAILED DESCRIPTION

[0065] It should be noted that, in the absence of conflict, the embodiments and features of the embodiments in this application can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0066] The present invention provides an ablation device, please refer to Figures 1 to 19 The ablation device includes a first electrode assembly 100 and a second electrode assembly 200, the first electrode assembly 100 includes a first electrode terminal 110, and the first electrode terminal 110 has a first electrode 111; the second electrode assembly 200 includes a second electrode terminal 210, and the second electrode terminal 210 has a second electrode 211; wherein the first electrode 111 and the second electrode 211 are arranged opposite to each other, so as to ablate the tissue 340 to be ablated located between the first electrode 111 and the second electrode 211 through the first electrode 111 and the second electrode 211.

[0067] In the ablation device of the present invention, the ablation device includes a first electrode assembly 100 and a second electrode assembly 200, the first electrode assembly 100 includes a first electrode end 110 having a first electrode 111, and the second electrode assembly 200 includes a second electrode end 210 having a second electrode 211, and the first electrode 111 and the second electrode 211 are arranged relative to each other so as to ablate the tissue 340 to be ablated located between the first electrode 111 and the second electrode 211 through the first electrode 111 and the second electrode 211. During specific use, the first electrode assembly 100 and the second electrode assembly 200 are used as epicardial electrodes and endocardial electrodes, respectively, so that the first electrode assembly 100 and the second electrode assembly 200 act on the epicardium and the endocardium, respectively, to achieve simultaneous ablation of the epicardium and the endocardium, thereby achieving a good ablation effect; it can be seen that the use of this ablation device can solve the current problem that both internal and external ablation are unilateral wall-adhering work, the ablation depth is limited, and it is difficult to ensure that the tissue is completely dehydrated and transmural from the inside to the outside, and solves the problem of unsatisfactory ablation effect of the ablation device in the prior art.

[0068] Because interventional ablation in internal medicine uses constant energy, the output power cannot be adjusted according to the ablation effect, leading to over-ablation or wall penetration. Cardiac surgery uses dynamic ablation, which measures impedance and detects signals in real time, adjusting power accordingly. However, surgical ablation is more invasive and can result in slow postoperative recovery. The ablation device in this invention uses a paired endocardial and epicardial ablation device, dynamically adjusting power in real time, addressing over-ablation or wall penetration, as well as tissue necrosis and even burn-through.

[0069] It can be seen that the ablation device in the present application can realize hybrid internal and surgical ablation. This technology has low trauma and solves the problem of large trauma and slow recovery of surgical ablation in the existing technology. At the same time, it can simultaneously ablate the epicardium and endocardium, and adjust the output power by testing the actual impedance between tissues. It is accurate and safe, and when the impedance reaches a certain resistance value, the machine alarm indicates that the ablation is completed, avoiding excessive ablation.

[0070] Specifically, the ablation device further includes an ablation circuit 320, on which the first electrode 111 and the second electrode 211 are both disposed, so as to perform ablation by adjusting the radiofrequency energy between the first electrode 111 and the second electrode 211 by testing the impedance between the first electrode 111 and the second electrode 211. By disposing the first electrode 111 and the second electrode 211 relative to each other, the impedance between the first electrode 111 and the second electrode 211 can be tested in real time, and the radiofrequency power between the first electrode 111 and the second electrode 211 can be adjusted based on the impedance between the first electrode 111 and the second electrode 211 detected in real time. When the impedance reaches a certain resistance value, the machine alarm indicates that the ablation is complete, thereby avoiding excessive ablation. This solves the problem of limited unilateral ablation depth and difficulty in ensuring complete dehydration and denaturation of tissue from the inside out in invasive ablation in the prior art. At the same time, it solves the problem of difficult control of radiofrequency power. Low power will result in incomplete ablation, while excessive power will cause excessive ablation, tissue necrosis, or even burn-through and burn-leakage.

[0071] During the specific ablation process, the impedance of the ablated tissue between the electrodes changes from low to high; in the first stage of ablation, the impedance of the ablated tissue between the electrodes gradually increases, and the radio frequency power remains unchanged to accelerate the vibration of molecules in the cells; in the second stage of ablation, as the impedance of the ablated tissue between the electrodes increases, the radio frequency power gradually increases. When the impedance of the ablated tissue between the electrodes increases to its first preset value, the radio frequency power also increases to its preset maximum value. In this ablation stage, the cells are rapidly dehydrated to produce irreversible changes; in the third stage of ablation, as the impedance of the ablated tissue between the electrodes continues to increase, the radio frequency power gradually decreases to ensure the thoroughness of the ablation while preventing scabs on the tissue surface or damage to the patient due to high radio frequency output; until the impedance of the ablated tissue between the electrodes increases to its second preset value, the ablation is terminated.

[0072] Preferably, if Figure 2 and Figure 7 As shown, there are multiple first electrodes 111 and multiple second electrodes 211, and the multiple first electrodes 111 and the multiple second electrodes 211 are arranged in cooperation with each other; by setting multiple first electrodes 111 and multiple second electrodes 211, the multiple first electrodes 111 and the multiple second electrodes 211 can act on their corresponding tissues at the same time to enhance the ablation effect and improve the ablation efficiency.

[0073] Specifically, the first electrode tip 110 and the second electrode tip 210 are both strip-shaped, with multiple first electrodes 111 spaced apart along the extension direction of the first electrode tip 110, and multiple second electrodes 211 spaced apart along the extension direction of the second electrode tip 210. Each first electrode 111 is paired with its corresponding second electrode 211. That is, the multiple first electrodes 111 and the multiple second electrodes 211 simultaneously act on their corresponding tissues to form a complete ablation line, ensuring the ablation effect and improving ablation efficiency. Furthermore, the spaced arrangement of the multiple first electrodes 111 and the multiple second electrodes 211 can prevent mutual interference between adjacent first electrodes 111 and adjacent second electrodes 211. In this embodiment, there are 2 to 10 first electrodes 111 and second electrodes 211.

[0074] Specifically, when the first electrode 111 and the second electrode 211 are working, each electrode is relatively independent, that is, the number of working electrodes can be controlled.

[0075] In this embodiment, the first electrode tip 110 further includes a positioning member 117, which is used to position the first electrode tip 110 on the epicardium. Specifically, the positioning members 117 are provided in pairs, and each pair of positioning members 117 operates relatively independently during operation. That is, the number of positioning members in operation can be determined based on actual needs.

[0076] Optionally, the positioning member 117 is a suction cup structure.

[0077] In this embodiment, the first electrode tip 110 further includes a first protective sheath 113 , and at least a portion of the first electrode 111 is disposed within the first protective sheath 113 ; that is, a plurality of first electrodes 111 are spaced apart and disposed within the first protective sheath 113 along an extending direction of the first protective sheath 113 .

[0078] Specifically, the first protective sheath 113 is made of a flexible material, so that the first protective sheath 113 can swing in the XYZ directions.

[0079] In this embodiment, if Figure 3 As shown, the first electrode 111 has an electrode surface 1110 disposed toward the tissue to be ablated 340 , and the first protective sheath 113 has a protective sheath surface 1130 disposed toward the tissue to be ablated 340 ; wherein the electrode surface 1110 is located on the side of the protective sheath surface 1130 close to the tissue to be ablated 340 .

[0080] In this embodiment, multiple first electrodes 111 are arranged at intervals along the extension direction of the first electrode tip 110. The minimum distance between the electrode surface 1110 of each of the first electrodes 111 and the protective sheath surface 1130 is the same. The minimum distance between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 ranges from 0 to 0.5 mm. This height difference ensures sufficient contact between the first electrode and the ablated surface, ensuring an effective ablation. The preferred height difference between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is 0.2 mm.

[0081] In this embodiment, the electrode surface 1110 and the protective sheath surface 1130 are both planes.

[0082] In order to cool the first electrode tip 110, Figure 2 As shown, there are multiple first electrodes 111, which are spaced apart along the extension direction of the first electrode tip 110. At least one of the multiple first electrodes 111 is provided with a cooling hole 114 for circulating a cooling fluid. And / or, a cooling channel for circulating a cooling fluid is provided within the first protective sheath 113. In this embodiment, the provision of cooling holes 114 is used to locally reduce the temperature during the ablation process, thereby protecting the ablated tissue from excessive burning.

[0083] In this embodiment, at least one of the plurality of first electrodes 111 is provided with 1 to 4 cooling holes 114. The number of cooling holes on each first electrode 111 is 0-4 to ensure temperature control during the ablation process.

[0084] Optionally, the first protective sheath 113 is tubular, and the plurality of first electrodes 111 are all disposed in the lumen of the first protective sheath 113 .

[0085] Specifically, if Figure 3 and Figure 5 As shown, the positioning member 117 includes an inner suction wall 1171 and an outer suction wall 1172, a suction cavity 1173 is formed between the inner suction wall 1171 and the outer suction wall 1172, and a first suction port 1174 and a second suction port 1175 connected to the suction cavity 1173, and the first suction port 1174 and the second suction port 1175 have the same direction.

[0086] The suction inner wall 1171 and the suction outer wall 1171 are both U-shaped structures, and the suction inner wall 1171 and the suction outer wall 1172 are arranged around the first protective sheath 113 .

[0087] The positioning member 117 further includes an air flow channel 1176 , an air outlet end of the air flow channel 1176 being in communication with the suction cavity 1173 so as to fill or exhaust air into the suction cavity 1173 through the air flow channel 1176 .

[0088] Optionally, there are multiple positioning members 117 , and the multiple positioning members 117 are arranged along the extension direction of the first electrode terminal 110 , so that the first electrode terminal 110 is stably positioned on the epicardium, thereby ensuring the positioning effect of the first electrode terminal 110 .

[0089] Specifically, multiple positioning members 117 are arranged in pairs, and the two pairs of positioning members 117 are respectively arranged on opposite sides of the first protective sheath 113 to ensure that both sides of the first protective sheath 113 have a good fit with the ablated tissue, so that the corresponding first electrode 111 can better act on its corresponding ablated tissue to ensure the ablation effect.

[0090] Specifically, multiple positioning members 117 are arranged on one side of the first protective sheath 113 to ensure good fit between one side of the first protective sheath 113 and the ablated tissue, so that the corresponding first electrode 111 can better act on its corresponding ablated tissue to ensure the ablation effect.

[0091] Multiple pairs of positioning members 117 are arranged at intervals along the extension direction of the first protective sheath 113 to ensure the overall fit between the first protective sheath 113 and the ablated tissue, so that each first electrode 111 can better act on its corresponding ablated tissue, thereby ensuring the ablation effect.

[0092] In this embodiment, the first electrode terminal 110 also includes a first magnetic part 112, and the second electrode terminal 210 includes a second magnetic part 212. The first magnetic part 112 and the second magnetic part 212 cooperate to relatively fix the first electrode terminal 110 and the second electrode terminal 210, so that the first electrode 111 of the first electrode terminal 110 can be arranged relative to the corresponding second electrode 211 of the second electrode terminal 210.

[0093] Specifically, there are multiple first magnetic parts 112 and multiple second magnetic parts 212, and the multiple first magnetic parts 112 are arranged at intervals along the extension direction of the first electrode end 110, and the multiple second magnetic parts 212 are arranged at intervals along the extension direction of the second electrode end 210 to ensure the overall fixing effect between the first electrode end 110 and the second electrode end 210.

[0094] Specifically, each pair of first magnetic members 112 and second magnetic members 212 works relatively independently, that is, the number of magnetic members working can be determined according to actual needs.

[0095] Optionally, the magnetic force of the magnetic part is controllable and adjustable, with a smaller magnetic force used for initial positioning and a larger magnetic force used for final positioning, so that the inner and outer electrode assemblies are flexible during initial positioning and firm after final positioning, ensuring the fit of the electrodes and thus ensuring the ablation effect.

[0096] Optionally, the plurality of first magnetic members 112 are all disposed in the lumen of the first protective sheath 113 .

[0097] Optionally, the first magnetic member 112 is an electromagnet or a permanent magnet; and / or the second magnetic member 212 is an electromagnet or a permanent magnet.

[0098] Specifically, if Figure 2 As shown, a plurality of first magnetic members 112 are all arranged in the first protective sheath 113, and the plurality of first magnetic members 112 are spaced apart along the extension direction of the first protective sheath 113. Preferably, the plurality of first magnetic members 112 and the plurality of first electrodes 111 are staggered along the extension direction of the first protective sheath 113 so that the plurality of first electrodes 111 are spaced apart, that is, each first magnetic member 112 is used to separate the corresponding two first electrodes 111. When working, each pair of first magnetic members and second magnetic members works relatively independently, that is, the number of working magnetic members can be determined according to actual needs. The magnetic force of the magnetic member is controllable and adjustable. A smaller magnetic force is used for initial positioning, and a larger magnetic force is used for final positioning, so that the inner and outer electrode assemblies are flexible during initial positioning and firm after final positioning, thereby ensuring the fit of the electrodes and thus ensuring the ablation effect.

[0099] When the first magnetic member 112 is in a non-working state, ie, not magnetically conducting, the first electrode assembly can achieve linear ablation of the epicardium at the epicardium.

[0100] In this embodiment, if Figure 4 As shown, shielding side eaves 115 are provided on opposite sides of the first protective sheath 113 to form a shielding and protective effect on the multiple first electrodes 111 and the multiple first magnetic members 112 inside the first protective sheath 113, so as to prevent the blood of the pericardial tissue from entering the area between the first protective sheath 113 and the epicardium during the ablation process, thereby affecting the tightness between the first protective sheath 113 and the epicardium, and avoiding the measurement accuracy of the resistance value between the first electrode and the second electrode during ablation, thereby affecting the ablation effect.

[0101] In some embodiments, there are multiple first electrodes 111 and multiple second electrodes 211 . The multiple first magnetic members 112 are alternately arranged with the multiple first electrodes 111 , and the multiple second magnetic members 212 are alternately arranged with the multiple second electrodes 211 .

[0102] In some embodiments, adjacent first electrodes 111 and first magnetic members 112 are insulated from each other, and adjacent second electrodes 211 and second magnetic members 212 are insulated from each other.

[0103] In some embodiments, the opposing surfaces of adjacent first electrodes 111 and first magnetic members 112 are sprayed with insulating paint, or an insulating separator is provided between adjacent first electrodes 111 and first magnetic members 112; the opposing surfaces of adjacent second electrodes 211 and second magnetic members 212 are sprayed with insulating paint, or an insulating separator is provided between adjacent second electrodes 211 and second magnetic members 212. The insulating separator is designed to be integrated with the protective sheath or fixed separately.

[0104] In some embodiments, outer surfaces of the first magnetic member 112 and the second magnetic member 212 are both covered with an insulating layer.

[0105] In some embodiments, the first electrode 111, first magnetic member 112, second electrode 211, and second magnetic member 212 are each connected to an independent energized circuit for separate control. Multiple first electrodes, second electrodes, first magnetic members, and second magnetic members can operate independently, allowing for adjustment of magnetic properties and the number of ablation electrodes. Two adjacent first electrodes or second electrodes can form an ablation electrode pair to achieve ablation.

[0106] In some embodiments, there are multiple first electrodes 111, and the power circuits of the two first electrodes 111 are independently set to form a mapping electrode pair, so as to use the power circuit to detect the electrical signal transmission status of the tissue to be ablated 340 after ablation; and / or, there are multiple second electrodes 211, and the power circuits of the two second electrodes 211 are independently set to form a mapping electrode pair, so as to use the power circuit to detect the electrical signal transmission status of the tissue to be ablated 340 after ablation; and / or, the power circuits of the first electrode 111 and the second electrode 211 are independently set to form a mapping electrode pair, so as to use the power circuit to detect the electrical signal transmission status of the tissue to be ablated 340 after ablation. During mapping, the two first electrodes 111 forming the mapping electrode pair have different polarities, and are set across a voltage to form a current, thereby achieving mapping; the two second electrodes 211 forming the mapping electrode pair have different polarities, and are set across a voltage to form a current, thereby achieving mapping. The first electrode and the second electrode forming the mapping electrode pair have different polarities, and are set across a voltage to form a current, thereby achieving mapping.

[0107] In some embodiments, there are multiple first electrode tips 110 and multiple second electrode tips 210. Figures 12 to 15 As shown, it can be seen that the ablation principle of the ablation device in this embodiment on the ablated tissue 340 can be reflected, and the ablation range 330 of the ablation device can be reflected.

[0108] In this embodiment, if Figure 7 and Figure 8As shown, the second electrode tip 210 includes a second protective sheath 214, and the second electrode 211 is arranged on the second protective sheath 214; the second electrode 211 is made of a metal material, and the metal material includes at least one of the following materials: platinum, platinum alloy, tantalum, and gold-plated beryllium bronze; and / or, the second protective sheath 214 is made of a developing material, and the components of the developing material include barium sulfate BaSO4.

[0109] In this embodiment, the developing element 213, the developing second electrode 211, and the developing second protective sheath 214 indicate the position of the second electrode assembly 200 when it enters the tissue to be ablated. Optionally, the number of developing elements 213 on the second electrode tip 210 can range from 1 to 6, and they can be provided separately, or the second electrode 211 can also incorporate the developing function. In this embodiment, the outer walls of the developing elements 213 and the second protective sheath 214 are flush, preventing damage to the patient during surgery.

[0110] In this embodiment, the second electrodes 211 are spaced apart along the extension direction of the second protective sheath 214, are sleeved on the second protective sheath 214, and have their surfaces higher than the surface of the second protective sheath 214. There may be no developing member 213, or there may be multiple developing members 213, with the multiple developing members 213 spaced apart along the extension direction of the second protective sheath 214; and / or the outer surface of the second protective sheath 214 is divided into a first surface portion corresponding to the developing member 213 and a second surface portion connected to the first surface portion, with the first surface portion being a recessed structure, and the developing member 213 sleeved on the first surface portion, with the outer surface of the developing member 213 being flush with or lower than the second surface portion.

[0111] During operation, the first electrode assembly 100 is first fixed to the epicardium using a positioning member. The second electrode assembly 200 is then placed inside the heart and, guided by the developing member 213, is placed in the tissue of the endocardium corresponding to the first electrode assembly 100. The first, second, and third pairs of magnetic members located on the first and second electrode tips 110, 210 are then activated synchronously and sequentially, completing the initial positioning of the two electrode groups. After initial positioning, the remaining magnetic members of the two electrode assemblies are then activated in pairs to complete final positioning.

[0112] Optionally, the shielding side eaves 115 are strip-shaped and extend along the extension direction of the first protective sheath 113. By providing the shielding side eaves 115, tissue fluid and liquids such as saline outside the ablation line can be blocked from entering the ablated tissue, thereby preventing the measurement accuracy of the resistance value between the first electrode and the second electrode during ablation, thereby affecting the ablation effect.

[0113] Specifically, a wire laying groove 120 for accommodating a wire is provided on the first electrode 111 and / or the first magnetic member 112 , and the wire is used to connect to the first electrode 111 ; alternatively, the wire laying groove 120 for laying the wire is provided on the inner wall of the first protective sheath 113 .

[0114] Specifically, the second electrode end 210 also includes a second protective sheath, and multiple second magnetic parts 212 and multiple second electrodes 211 are all mounted on the second protective sheath; optionally, the multiple second magnetic parts 212 and the multiple second electrodes 211 are staggered along the extension direction of the second protective sheath so that the multiple second electrodes 211 are arranged at intervals, that is, each second magnetic part 212 is used to separate the corresponding two second electrodes 211.

[0115] Optionally, refer to Figure 13 and Figure 19 The second magnetic members 212 and the second electrodes 211 are all annular structures, or polygonal, V-shaped, D-shaped, arched, or other cross-sectional structures. Figure 19 As shown, the cross section of the second electrode 211 is polygonal, specifically square.

[0116] The present invention also provides a radiofrequency ablation device, such as Figure 10 As shown, the radio frequency ablation device includes a radio frequency host 310 and the above-mentioned ablation device, and the ablation device is connected to the radio frequency host 310.

[0117] Specifically, if Figure 9 As shown, the RF host 310 is provided with a display screen 313 , which is used to display the impedance and / or RF power of the ablated tissue measured between the two corresponding first electrodes 111 and the second electrode 211 .

[0118] Specifically, an ablation interface 311 is also provided on the RF host 310. The first electrode assembly 100 and the second electrode assembly 200 both include multiple wire assemblies, each wire assembly includes a wire connector and multiple parallel-arranged wires connected to the wire connector, and each wire is used to connect to the corresponding electrode; the ablation interface 311 has a first ablation interface portion and a second ablation interface portion, the first ablation interface portion has multiple first ablation interfaces for inserting multiple wire connectors of the first electrode assembly 100, and the second ablation interface portion has multiple second ablation interfaces for inserting multiple wire connectors of the second electrode assembly 200, so as to provide appropriate RF power to the corresponding first electrode 111 and the corresponding second electrode 211 through each first ablation interface and each second ablation interface.

[0119] Specifically, when the first magnetic part 112 and the second magnetic part 212 are both electromagnets, an electromagnetic interface 312 is also provided on the RF host 310, and the first electrode assembly 100 and the second electrode assembly 200 both include multiple electromagnet assemblies, each electromagnet assembly includes an electromagnetic connector and multiple electromagnetic wires arranged in parallel connected to the electromagnetic connector, and each electromagnetic wire is used to connect to the corresponding electromagnet; the electromagnetic interface 312 has a first electromagnetic interface part and a second electromagnetic interface part, the first electromagnetic interface part has multiple first magnetic interfaces for inserting multiple electromagnetic connectors of the first electrode assembly 100, and the second electromagnetic interface part has multiple second magnetic interfaces for inserting multiple electromagnetic connectors of the second electrode assembly 200, so as to supply power to the corresponding first magnetic part 112 and the corresponding second magnetic part 212 through each first magnetic interface and each second magnetic interface, thereby generating an attractive force between the corresponding first magnetic part 112 and the corresponding second magnetic part 212.

[0120] From the above description, it can be seen that the above embodiments of the present invention achieve the following technical effects:

[0121] In the ablation device of the present invention, the ablation device includes a first electrode assembly 100 and a second electrode assembly 200. The first electrode assembly 100 includes a first electrode tip 110 having a first electrode 111, and the second electrode assembly 200 includes a second electrode tip 210 having a second electrode 211. The first electrode 111 and the second electrode 211 are arranged relative to each other so as to ablate the tissue 340 to be ablated between the first electrode 111 and the second electrode 211. In specific use, the first electrode assembly 100 and the second electrode assembly 200 are used as epicardial electrodes and endocardial electrodes, respectively, so that the first electrode assembly 100 and the second electrode assembly 200 act on the epicardium and the endocardium, respectively, to achieve simultaneous ablation of the epicardium and the endocardium, thereby achieving a good ablation effect. It can be seen that the use of the present ablation device can solve the problem of unsatisfactory ablation effect of the ablation devices in the prior art.

[0122] In addition, the ablation device in the present application can realize hybrid internal and surgical ablation. This technology has low trauma and solves the problem of large trauma and slow recovery of surgical ablation in the existing technology. At the same time, it can simultaneously ablate the epicardium and endocardium, and adjust the output power by testing the actual impedance between tissues. It is accurate and safe, and when the impedance reaches a certain resistance value, the machine alarm indicates that the ablation is completed, avoiding excessive ablation.

[0123] In addition, the first electrode assembly can be used independently to act on the epicardium to achieve an ablation effect, and the second electrode assembly can be used independently to act on the endocardium to achieve an ablation effect.

[0124] Whether performing endocardial ablation, epicardial ablation, or simultaneous endocardial and epicardial ablation, a single electrode assembly or coordinated electrode assemblies can perform timely mapping and monitor the ablation effect, solving the current problem that post-ablation mapping still requires the use of external instruments and is point-based mapping, thereby improving the surgical ablation effect.

[0125] The radiofrequency ablation device of the present invention includes the above-mentioned ablation device, so the radiofrequency ablation device has at least the same technical effect as the ablation device.

[0126] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used herein to describe the spatial positional relationship of a device or feature to other devices or features as shown in the figures. 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 figures. For example, if the device in the 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.

[0127] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, they indicate the presence of features, steps, operations, devices, components and / or combinations thereof.

[0128] It should be noted that the terms "first", "second", etc. in the specification and claims of the present application and the above-mentioned drawings are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchangeable where appropriate, so that the embodiments of the present application described herein can, for example, be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions, for example, a process, method, system, product or device comprising a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0129] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention are intended to be within the scope of protection of the present invention.

Claims

1. An ablation device, characterized in that: include: A first electrode assembly (100), the first electrode assembly (100) comprising a first electrode terminal (110), the first electrode terminal (110) having a first electrode (111); A second electrode assembly (200), the second electrode assembly (200) comprising a second electrode terminal (210), the second electrode terminal (210) having a second electrode (211); The first electrode (111) and the second electrode (211) cooperate with each other to ablate the tissue to be ablated (340) located between the first electrode (111) and the second electrode (211) through the first electrode (111) and the second electrode (211); The first electrode tip (110) comprises a first protective sheath (113), and at least a portion of the first electrode (111) is disposed within the first protective sheath (113); the first protective sheath (113) is made of a flexible material so that the first protective sheath (113) can swing in the XYZ directions; a cooling channel for circulating a cooling fluid is disposed within the first protective sheath (113); Shielding side eaves (115) are provided on opposite sides of the first protective sheath (113); The first electrode terminal (110) comprises a positioning member (117), and the first electrode terminal (110) is positioned on the epicardium via the positioning member (117); the positioning member (117) is a suction cup structure; The positioning member (117) includes an inner suction wall (1171) and an outer suction wall (1172), a suction cavity (1173) is formed between the inner suction wall (1171) and the outer suction wall (1172), a first suction port (1174) and a second suction port (1175) communicated with the suction cavity (1173), the first suction port (1174) and the second suction port (1175) are oriented in the same direction, the inner suction wall (1171) and the outer suction wall (1172) are both U-shaped structures, and the inner suction wall (1171) and the outer suction wall (1172) are both arranged around the first protective sheath (113); When the ablation device ablates the tissue to be ablated (340), the second electrode tip (210) is arranged relative to a portion between the first suction port (1174) and the second suction port (1175).

2. The ablation device according to claim 1, wherein: The ablation device further comprises: An ablation circuit (320) is provided on which the first electrode (111) and the second electrode (211) are both arranged to perform ablation by adjusting radio frequency energy between the first electrode (111) and the second electrode (211) by testing the impedance between the first electrode (111) and the second electrode (211).

3. The ablation device according to claim 1, wherein: There are multiple first electrodes (111) and multiple second electrodes (211), and the multiple first electrodes (111) and the multiple second electrodes (211) are arranged in coordination with each other.

4. The ablation device according to claim 3, characterized in that: The first electrode terminal (110) and the second electrode terminal (210) are both bar-shaped, a plurality of first electrodes (111) are arranged at intervals along the extension direction of the first electrode terminal (110), and a plurality of second electrodes (211) are arranged at intervals along the extension direction of the second electrode terminal (210).

5. The ablation device according to claim 3, characterized in that: The number of the first electrodes (111) and the number of the second electrodes (211) are 2 to 10.

6. The ablation device according to claim 1, wherein: The first electrode terminal (110) is in a bar shape, and there are a plurality of positioning members (117), wherein the plurality of positioning members (117) are arranged along an extension direction of the first electrode terminal (110).

7. The ablation device according to claim 1, characterized in that There are a plurality of positioning members (117), and the plurality of positioning members (117) are arranged in pairs, with the two positioning members (117) in a pair being arranged on opposite sides of the first protective sheath (113); and / or, the plurality of positioning members (117) are arranged on one side of the first protective sheath (113).

8. The ablation device according to claim 7, characterized in that: The first protective sheath (113) is made of a flexible material.

9. The ablation device according to claim 7, characterized in that: The first electrode (111) has an electrode surface (1110) arranged toward the tissue to be ablated (340), and the first protective sheath (113) has a protective sheath surface (1130) arranged toward the tissue to be ablated (340); wherein the electrode surface (1110) is located on a side of the protective sheath surface (1130) close to the tissue to be ablated (340).

10. The ablation device according to claim 9, characterized in that: There are multiple first electrodes (111), and the multiple first electrodes (111) are arranged at intervals along the extension direction of the first electrode terminal (110); the minimum distances between the electrode surfaces (1110) of the multiple first electrodes (111) and the protective sheath surface (1130) are all the same.

11. The ablation device according to claim 9, characterized in that: The electrode surface (1110) and the protective sheath surface (1130) are both planes.

12. The ablation device according to claim 1, wherein: There are a plurality of first electrodes (111), and the plurality of first electrodes (111) are arranged at intervals along the extension direction of the first electrode terminal (110); at least one of the plurality of first electrodes (111) is provided with a cooling hole (114) for circulating a cooling fluid; and / or A cooling pipe for circulating cooling fluid is provided in the first protective sheath (113).

13. The ablation device according to claim 12, wherein: At least one of the plurality of first electrodes (111) is provided with 1 to 4 cooling holes (114).

14. The ablation device according to claim 1, wherein: The first electrode terminal (110) includes a first magnetic part (112), and the second electrode terminal (210) includes a second magnetic part (212). The first magnetic part (112) and the second magnetic part (212) cooperate with each other to relatively fix the first electrode terminal (110) and the second electrode terminal (210).

15. The ablation device according to claim 14, characterized in that The first magnetic member (112) and the second magnetic member (212) are both plural, the first electrode terminal (110) and the second electrode terminal (210) are both bar-shaped, the plural first magnetic members (112) are arranged at intervals along the extension direction of the first electrode terminal (110), and the plural second magnetic members (212) are arranged at intervals along the extension direction of the second electrode terminal (210).

16. The ablation device according to claim 15, characterized in that There are multiple first electrodes (111) and multiple second electrodes (211), multiple first magnetic members (112) and multiple first electrodes (111) are arranged in a staggered manner, and multiple second magnetic members (212) and multiple second electrodes (211) are arranged in a staggered manner.

17. The ablation device according to claim 16, characterized in that Adjacent first electrodes (111) and first magnetic members (112) are insulated from each other, and adjacent second electrodes (211) and second magnetic members (212) are insulated from each other.

18. The ablation device according to claim 16, wherein: The opposing surfaces between adjacent first electrodes (111) and first magnetic members (112) are sprayed with insulating paint, or an insulating partition is provided between adjacent first electrodes (111) and first magnetic members (112); the opposing surfaces between adjacent second electrodes (211) and second magnetic members (212) are sprayed with insulating paint, or an insulating partition is provided between adjacent second electrodes (211) and second magnetic members (212).

19. The ablation device according to claim 14, wherein: The outer surfaces of the first magnetic component (112) and the second magnetic component (212) are both covered with an insulating layer.

20. The ablation device according to claim 14, wherein: The first electrode (111), the first magnetic member (112), the second electrode (211), and the second magnetic member (212) are all connected to independent energized circuits for individual control.

21. The ablation device according to claim 1, wherein There are multiple first electrodes (111), and the power circuits of two of the first electrodes (111) are independently set to form a mapping electrode pair, so as to use the power circuit to detect the electrical signal transmission status of the tissue to be ablated (340) after ablation; and / or, there are multiple second electrodes (211), and the power circuits of two of the second electrodes (211) are independently set to form a mapping electrode pair, so as to use the power circuit to detect the electrical signal transmission status of the tissue to be ablated (340) after ablation; and / or, the power circuits of the first electrode (111) and the second electrode (211) are independently set to form a mapping electrode pair, so as to use the power circuit to detect the electrical signal transmission status of the tissue to be ablated (340) after ablation.

22. The ablation device according to claim 1, wherein There are multiple first electrode terminals (110) and multiple second electrode terminals (210).

23. The ablation device according to claim 1, wherein: The second electrode tip (210) comprises a second protective sheath (214), and the second electrode (211) is arranged on the second protective sheath (214); The second electrode (211) is made of a metal material, and the metal material includes at least one of the following materials: platinum, platinum-iridium alloy, tantalum, and gold-plated beryllium bronze; and / or, The second protective sheath (214) is made of a developing material, and the developing material comprises barium sulfate.

24. The ablation device according to claim 23, wherein: The second electrodes (211) are arranged at intervals along the extension direction of the second protective sheath (214), are sleeved on the second protective sheath (214), and the surface of the electrodes is higher than the surface of the second protective sheath (214).

25. A radiofrequency ablation device, comprising a radiofrequency host (310) and an ablation device connected to the radiofrequency host (310), characterized in that: The ablation device is the ablation device according to any one of claims 1 to 24.

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