WO2022148159A1 - Electrode assembly, ablation device and radiofrequency ablation apparatus - Google Patents

Electrode assembly, ablation device and radiofrequency ablation apparatus Download PDF

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Publication number
WO2022148159A1
WO2022148159A1 PCT/CN2021/132424 CN2021132424W WO2022148159A1 WO 2022148159 A1 WO2022148159 A1 WO 2022148159A1 CN 2021132424 W CN2021132424 W CN 2021132424W WO 2022148159 A1 WO2022148159 A1 WO 2022148159A1
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WIPO (PCT)
Prior art keywords
electrode
electrodes
ablation
protective sheath
electrode assembly
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PCT/CN2021/132424
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French (fr)
Chinese (zh)
Inventor
马志伟
马帅
王宇
周庆亮
申佳佳
孟坚
Original Assignee
北京迈迪顶峰医疗科技股份有限公司
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Priority claimed from CN202120046531.XU external-priority patent/CN215349402U/en
Priority claimed from CN202110026567.6A external-priority patent/CN114748156A/en
Application filed by 北京迈迪顶峰医疗科技股份有限公司 filed Critical 北京迈迪顶峰医疗科技股份有限公司
Publication of WO2022148159A1 publication Critical patent/WO2022148159A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor

Definitions

  • the present disclosure is based on a Chinese patent application with an application number of 202110026567.6, an application date of January 8, 2021, and a public name of "electrode assembly, ablation device and radiofrequency ablation device” and an application number of 202120046531.X, and the application date of 2021.
  • a Chinese patent application entitled “Ablation Device and Radio Frequency Ablation Apparatus” was published as the basis and claimed priority, the disclosure of which is hereby incorporated into the present disclosure in its entirety.
  • the present disclosure relates to the field of medical devices, and in particular, to an electrode assembly, an ablation device, and a radiofrequency ablation device.
  • Ablation is a common measure for the treatment of atrial fibrillation.
  • the 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.
  • Surgical ablation is characterized by excellent curative effect and low postoperative recurrence rate, but its obvious shortcomings are large trauma and slow postoperative recovery.
  • Medical interventional ablation is favored by more and more patients because of its small trauma and fast recovery, but medical ablation is point ablation, and its biggest drawback is that it is difficult to form a complete ablation line; Wall work, the ablation depth is limited, and it is difficult to ensure complete dehydration and degeneration of the tissue from the inside to the outside.
  • the ablation power is small and the ablation is not complete, but the power is high and it is difficult to control. There are excessive ablation tissue necrosis or even burning through and burning leakage. Therefore, the success rate of medical interventional ablation is much lower than that of surgery.
  • the main purpose of the present disclosure is to provide an electrode assembly, an ablation device and a radio frequency ablation device, so as to solve the problems in the prior art that the ablation device is not firmly attached to the tissue to be ablated, the tissue to be ablated is easily detached, and the ablation effect is not ideal .
  • a first aspect of the present disclosure provides an electrode assembly, including a first electrode tip, the first electrode tip comprising: a first protective sheath; and a first electrode, the first electrode is disposed in the first protective sheath ; a filling piece, the filling piece is arranged in the first protective sheath, so as to press the first electrode in the first protective sheath towards the tissue to be ablated through the filling piece.
  • the first protective sheath is strip-shaped, and the plurality of the first electrodes are arranged at intervals along the extending direction of the first protective sheath.
  • the filler is in the shape of a bar
  • the first protective sheath is in the shape of a bar
  • the filler extends along the extending direction of the first protective sheath.
  • the first protective sheath is strip-shaped, and the plurality of the fillers are arranged at intervals along the extending direction of the first protective sheath.
  • a plurality of the fillers and a plurality of the first electrodes are arranged in a one-to-one correspondence, and each of the fillers is arranged at a distance from the corresponding first electrode away from the to-be-ablated electrode. side of the tissue.
  • the energization circuits of the plurality of first electrodes are provided independently, so as to individually control each of the first electrodes.
  • the ventilation lines of the plurality of fillers are independently provided, so as to individually control the inflation state of each of the fillers.
  • the filler is a balloon structure or the filler is a flexible block.
  • the first protective sheath is provided with an opening structure for avoiding the first electrode, so that part of the structure of the first electrode can pass through the opening structure from the first electrode.
  • the lumen of a protective sheath protrudes.
  • the opening structure includes a plurality of avoidance holes
  • the plurality of avoidance holes are provided in a one-to-one correspondence with the plurality of the first electrodes , so that part of the structure of each of the first electrodes protrudes to the outside of the first protective sheath through the corresponding avoidance holes.
  • the opening structure is a strip-shaped opening, and the strip-shaped openings are spaced along the extending direction of the first protective sheath, and a plurality of the first electrodes are formed. A part of the structure of an electrode protrudes to the outside of the first protective sheath through the strip-shaped opening.
  • a second aspect of the present disclosure provides an ablation device, including a first electrode assembly and a second electrode assembly, wherein the first electrode assembly is the electrode assembly described in the first aspect of the disclosure, and the second electrode assembly includes a first electrode assembly.
  • the second electrode tip includes a second protective sheath, the second electrodes are multiple, and the plurality of second electrodes are sheathed on the second protective sheath; wherein , a plurality of the first electrodes and a plurality of the second electrodes are arranged in cooperation with each other.
  • the ablation device further comprises: an ablation circuit, on which the first electrode and the second electrode are both disposed, so as to pass the test of the first electrode and the corresponding
  • the impedance between the second electrodes modulates the radio frequency energy between the first electrode and the second electrode for ablation.
  • a third aspect of the present disclosure further provides a radio frequency ablation device, comprising a radio frequency host and an ablation device connected to the radio frequency host, wherein the ablation device is the ablation device described in the second aspect of the present disclosure.
  • the electrode assembly includes a first electrode tip, the first electrode tip includes a first protective sheath, a first electrode and a filling member disposed in the first protective sheath, and the first electrode is connected to the first electrode through the filling member.
  • FIG. 1 shows a schematic structural diagram of an optional electrode assembly (first electrode assembly) according to the present disclosure
  • FIG. 2 shows a longitudinal cross-sectional structural view of the first electrode assembly in FIG. 1;
  • Fig. 3 is a schematic diagram showing a structural arrangement of the first electrode assembly in Fig. 1 with shielding side eaves;
  • FIG. 4 is a schematic diagram showing another structural arrangement of the first electrode assembly in FIG. 1 with shielding side eaves;
  • FIG. 5 shows a schematic diagram of the structural arrangement of the first electrode assembly in FIG. 1 with wire laying grooves
  • FIG. 6 shows a cross-sectional view of another embodiment of a first electrode assembly according to the present disclosure
  • FIG. 7 shows a schematic structural diagram of a second electrode assembly of an optional ablation device according to the present disclosure
  • FIG. 8 shows a partial enlarged view of the second electrode assembly of the ablation device of FIG. 7;
  • FIG. 9 shows an enlarged view of part A of the second electrode assembly of the ablation device of FIG. 8;
  • FIG. 10 shows a schematic structural diagram of a radio frequency host of an optional radio frequency ablation device according to the present disclosure
  • FIG. 11 shows an assembly diagram between a radio frequency host and an ablation device of an optional radio frequency ablation device according to the present disclosure
  • FIG. 12 shows a schematic diagram of the ablation device in the present disclosure when the tissue to be ablated is ablated
  • FIG. 13 shows a diagram of the cooperation between the first electrode and the second electrode and the tissue to be ablated in an embodiment of the ablation device in the present disclosure
  • FIG. 14 shows a schematic diagram of ablation in one state of the ablation device of the present disclosure
  • FIG. 15 shows an ablation schematic diagram of another state of the ablation device of the present disclosure
  • FIG. 16 shows a schematic diagram of the wiring between the radio frequency host and the first electrode assembly and the second electrode assembly of the radio frequency ablation device of the present disclosure
  • FIG. 17 shows a schematic structural diagram of the second embodiment of the first electrode assembly of the ablation device of the present disclosure
  • FIG. 18 shows a schematic structural diagram of the second embodiment of the second electrode assembly of the ablation device of the present disclosure
  • FIG. 19 shows a diagram of the cooperation between the first electrode and the second electrode and the tissue to be ablated in another embodiment of the ablation device of the present disclosure.
  • a first electrode assembly comprising
  • a second electrode assembly 200.
  • radio frequency host 311, ablation interface; 312, electromagnetic interface; 313, display screen; 320, ablation circuit; 330, ablation range; 340, tissue to be ablated.
  • the electrode assembly includes a first electrode tip 110 , the first electrode tip 110 includes a first protective sheath 113 , a first electrode 111 and a filler 116 ,
  • the first electrode 111 is disposed in the first protective sheath 113 ;
  • the filling member 116 is disposed in the first protective sheath 113 , so that the first electrode 111 in the first protective sheath 113 is pressed toward the tissue to be ablated by the filling member 116 .
  • the electrode assembly includes a first electrode tip 110, the first electrode tip 110 includes a first protective sheath 113, and a first electrode 111 and a filler 116 disposed in the first protective sheath 113,
  • the first electrode 111 is squeezed by the filler 116 to move the first electrode 111 toward the tissue to be ablated, so that the first electrode 111 can fit with the inner wall of the first protective sheath 113, and the first electrode 111 at the corresponding position
  • the outer wall of the protective sheath 113 is attached to the corresponding tissue to be ablated, so as to ensure that the first electrode 111 can better act on the corresponding tissue to be ablated and ensure the ablation effect; it can be seen that the use of this electrode assembly can solve the problems of internal medicine in the prior art.
  • the problem of unsatisfactory ablation effect of interventional ablation device is disposed in the first protective sheath 113, and a first electrode 111 and a filler 116 disposed in the first protective sheath
  • the first protective sheath 113 is strip-shaped, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first protective sheath 113 ; that is, the multiple first electrodes 111 act on the The corresponding tissue to be ablated to form a complete ablation line, ensuring ablation effect and improving ablation efficiency; and arranging a plurality of first electrodes 111 at intervals can avoid mutual influence between two adjacent first electrodes 111 .
  • the first protective sheath 113 is tubular, and the plurality of first electrodes 111 are disposed in the lumen of the first protective sheath 113 .
  • an arrangement of the filling member 116 is as follows: as shown in FIG.
  • the filler 116 is an airbag structure, so as to form a pressing effect on the plurality of first electrodes 111 when the airbag structure is inflated and expanded.
  • another arrangement of the fillers 116 is as follows: there are multiple fillers 116 , and the multiple fillers 116 are arranged at intervals along the extending direction of the first protective sheath 113 ; the multiple fillers 116 and the multiple The electrodes 111 are arranged in a one-to-one correspondence, so that each filling member 116 can form a pressing effect on the corresponding first electrode 111; each filling member 116 is arranged on the side of the corresponding first electrode 111 away from the tissue to be ablated, In order to realize that each filler 116 has a pressing effect on the corresponding first electrode 111 , each first electrode 111 moves toward the direction of approaching the corresponding tissue to be ablated.
  • each filling member 116 is an airbag structure, so that when the airbag structure is inflated and inflated, a pressing effect is formed on the corresponding first electrode 111 .
  • the energization circuits of the plurality of first electrodes 111 are independently set to individually control each of the first electrodes 111 .
  • the energization circuits of two adjacent first electrodes are independently arranged to form an ablation electrode pair to achieve an ablation function.
  • the ventilation lines of the plurality of fillers 116 are provided independently to individually control the inflation state of each filler 116 .
  • the first protective sheath 113 is provided with an opening structure for avoiding the first electrode 111, so that part of the structure of the first electrode 111 is protruded from the cavity of the first protective sheath 113 through the opening structure, so that, This part of the electrode structure extending out of the cavity of the first protective sheath 113 can be in direct contact with the corresponding tissue to be ablated, so that this part of the electrode structure can better act on the corresponding tissue to be ablated, so as to further ensure the ablation effect and improve the Ablation efficiency.
  • a setting form of the opening structure is: when there are multiple first electrodes 111 , the opening structure includes multiple avoidance openings, and the multiple avoidance openings correspond to the multiple first electrodes 111 one-to-one so that the part of the structure of each first electrode 111 protrudes to the outside of the first protective sheath 113 through the corresponding avoidance holes, so that the part of the structure of each first electrode 111 protruding from the outside of the first protective sheath 113 is Direct contact with the corresponding tissue to be ablated is possible.
  • the opening structure is a strip-shaped opening
  • the strip-shaped openings are spaced along the extending direction of the first protective sheath 113
  • the partial structures of the plurality of first electrodes 111 pass through the strips.
  • the shaped opening protrudes to the outside of the first protective sheath 113 .
  • the present disclosure also provides an ablation device, the ablation device includes a first electrode assembly 100 and a second electrode assembly 200, the first electrode assembly 100 is the above-mentioned electrode assembly, and the first electrode of the first electrode assembly 100 is the first electrode 111, that is, the first electrode end of the first electrode assembly 100 is the first electrode end 110, the second electrode assembly 200 includes the second electrode end 210, the second electrode end 210 includes the second electrode 211, the second electrode The 211 is disposed opposite to the first electrode 111 to ablate the tissue to be ablated between the first electrode 111 and the second electrode 211 through the first electrode 111 and the second electrode 211 .
  • 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 adjust the first electrode 111 and the corresponding second electrode 211 by testing the impedance between the first electrode 111 and the corresponding second electrode 211 .
  • the ablation is performed by radio frequency energy between the electrode 111 and the second electrode 211 .
  • the first electrode tip 110 of the first electrode assembly 100 includes a first magnetic member 112
  • the second electrode tip 210 includes a second magnetic member 212
  • the first magnetic member 112 and the second magnetic member 212 are in phase with each other. Matching, so that the first electrode end 110 and the second electrode end 210 are relatively fixed.
  • the first magnetic member 112 and the second magnetic member 212 are both multiple, the first electrode tip 110 and the second electrode tip 210 are both strip-shaped, and the multiple first magnetic members 112 are along the first The extending direction of the electrode tip 110 is arranged at intervals, and the plurality of second magnetic members 212 are arranged at intervals along the extending direction of the second electrode tip 210 .
  • first electrodes 111 and second electrodes 211 there are multiple first electrodes 111 and second electrodes 211 , multiple first magnetic members 112 and multiple first electrodes 111 are alternately arranged, multiple second magnetic members 212 and multiple second electrodes 111
  • the electrodes 211 are staggered and spaced apart.
  • the adjacent first electrodes 111 and the first magnetic members 112 are provided in insulation, and the adjacent second electrodes 211 and the second magnetic members 212 are provided in insulation.
  • the opposite surfaces between the adjacent first electrodes 111 and the first magnetic members 112 are sprayed with insulating paint, or an insulating spacer is provided between the adjacent first electrodes 111 and the first magnetic members 112
  • the opposite surfaces between the adjacent second electrodes 211 and the second magnetic members 212 are all sprayed with insulating paint, or an insulating separator is provided between the adjacent second electrodes 211 and the second magnetic members 212 .
  • the outer surfaces of the first magnetic member 112 and the second magnetic member 212 are covered with insulating layers.
  • the first electrode 111 , the first magnetic member 112 , the second electrode 211 and the second magnetic member 212 are all connected to independent energization circuits for individual control.
  • first electrodes 111 there are multiple first electrodes 111, and the energization circuits of the two first electrodes 111 are independently set to form a mapping electrode pair, so as to use the energization circuits to detect the transmission of electrical signals of the tissue to be ablated 340 after ablation; And/or, there are multiple second electrodes 211, and the energization circuits of the two second electrodes 211 are independently set to form a mapping electrode pair, so as to use the energization circuits to detect the electrical signal transmission of the tissue 340 to be ablated after ablation; and/or Alternatively, the energization 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 energization circuit to detect the transmission of electrical signals after the ablation of the tissue 340 to be ablated.
  • mapping the polarities of the two first electrodes 111 forming the mapping electrode pair are different, and the voltage across the voltage is set to form a current, thereby realizing mapping; the polarities of the two second electrodes 211 forming the mapping electrode pair are different, The cross-voltage is set to form a current, and then the mapping is realized; the polarities of the first electrode 111 and the second electrode 211 that form the mapping electrode pair are different, and the cross-voltage is set to form a current, and then the mapping is realized.
  • 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 heart, respectively membrane to achieve simultaneous epicardium and endocardium ablation for good ablation results.
  • the ablation device in the present disclosure can realize hybrid ablation of internal and surgical techniques. This technique has little trauma, which solves the problems of large trauma and slow recovery in the prior art for surgical ablation. Simultaneous ablation adjusts the output power by testing the actual impedance between tissues, which is accurate and safe, and the machine alarms when the impedance reaches a certain resistance value to complete the ablation to avoid excessive ablation.
  • the impedance between the first electrode 111 and the second electrode 211 can be tested in real time, and according to the real-time detection of the impedance between the first electrode 111 and the second electrode 211 Impedance to adjust the radio frequency energy between the first electrode 111 and the second electrode 211 for ablation, and after the impedance reaches a certain resistance value, the machine alarms that the ablation is completed, to avoid excessive ablation, to solve the unilateral ablation depth of the interventional ablation in the prior art It is limited and difficult to ensure the complete dehydration and degeneration of the tissue from the inside to the outside. At the same time, it solves the problem that the radio frequency power is not easy to control. Low power will cause incomplete ablation, and excessive power will cause excessive ablation, tissue necrosis or even burn through and leakage. Phenomenon.
  • the impedance of the tissue to be ablated between the electrodes changes from low to high; in the first stage of ablation, the impedance of the tissue to be ablated between the electrodes gradually increases, and the RF power remains unchanged to accelerate the intracellular molecules. Vibration; in the second stage of ablation, as the impedance of the ablated tissue between the electrodes increases, the radio frequency power gradually increases, and when the impedance of the ablated tissue between the electrodes increases to its first preset value, the radio frequency power It also increases to its preset maximum value.
  • 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 RF power gradually increases. It is decreased to ensure the completeness of ablation and prevent the phenomenon of scarring on the tissue surface or damage to the patient caused by the high power output of the radio frequency; until the impedance of the ablated tissue between the electrodes increases to its second preset value, the end of the ablation is prompted.
  • first electrodes 111 and multiple second electrodes 211 there are multiple first electrodes 111 and multiple second electrodes 211, and multiple first electrodes 111 and multiple second electrodes 211 are provided in one-to-one correspondence;
  • the first electrode 111 and the plurality of second electrodes 211 enable the plurality of first electrodes 111 and the plurality of second electrodes 211 to act on their corresponding tissues at the same time, so as to enhance the ablation effect and improve the ablation efficiency.
  • the first electrode tip 110 and the second electrode tip 210 are both strip-shaped, the plurality of first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110 , and the plurality of second electrodes 211 are arranged along the second
  • the extension directions of the electrode tips 210 are arranged at intervals, and each first electrode 111 and its corresponding second electrodes 211 are arranged in pairs; tissue, so as to form a complete ablation line and ensure the ablation effect; and the plurality of first electrodes 111 are arranged at intervals, and the plurality of second electrodes 211 are arranged at intervals, which can avoid the gap between two adjacent first electrodes 111 and between adjacent two electrodes 111.
  • the second electrodes 211 influence each other.
  • the first electrode tip further includes a first magnetic member 112
  • the second electrode tip 210 includes a second magnetic member 212
  • the first magnetic member 112 and the second magnetic member 212 cooperate to make the first
  • the electrode tip 110 and the second electrode tip 210 are relatively fixed, so that the first electrode 111 of the first electrode tip 110 can be disposed opposite to the corresponding second electrode 211 of the second electrode tip 210 .
  • first magnetic members 112 and second magnetic members 212 there are multiple first magnetic members 112 and second magnetic members 212 , the multiple first magnetic members 112 are arranged at intervals along the extending direction of the first electrode tip 110 , and the multiple second magnetic members 212 are arranged along the extending direction of the first electrode tip 110 .
  • the extending directions of the electrode terminals 210 are arranged at intervals to ensure the overall fixing effect between the first electrode terminal 110 and the second electrode terminal 210 .
  • each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs.
  • the magnetic force of the magnetic piece is controllable and adjustable, a small magnetic force is used in the initial positioning, and a large magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible in the initial positioning and firm in the final positioning, so as to ensure the electrode assembly.
  • the plurality of first magnetic members 112 are all disposed in the lumen of the protective sheath 113 .
  • the first magnetic member 112 is an electromagnet; and/or the second magnetic member 212 is an electromagnet.
  • the plurality of first magnetic members 112 are all disposed in the first protective sheath 113 , and the plurality of first magnetic members 112 are disposed at intervals along the extending direction of the first protective sheath 113 .
  • the plurality of first magnetic members 112 and the plurality of first electrodes 111 are alternately arranged along the extending direction of the protective sheath 113 , so that the plurality of first electrodes 111 are arranged at intervals, that is, each first magnetic member 112 is used to separate the corresponding of the two first electrodes 111 .
  • each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs.
  • the magnetic force of the magnetic parts is controllable and adjustable. A small magnetic force is used in the initial positioning, and a larger magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible at the initial positioning and firm after the final positioning, so as to ensure the fit of the electrodes. , thereby ensuring the ablation effect.
  • shielding side eaves 115 are provided on opposite sides of the protective sheath 113 to form shielding protection for the plurality of first electrodes 111 and the plurality of first magnetic members 112 inside the protective sheath 113 to avoid During the ablation process, blood in the epicardial tissue enters the area between the first protective sheath 113 and the epicardium, which affects the tightness between the protective sheath 113 and the epicardium, avoiding the first electrode 111 and the second electrode during ablation. The measurement accuracy of the resistance value between 211 affects the ablation effect.
  • the shielding side eave 115 by setting the shielding side eave 115, the tissue fluid outside the ablation line and liquids such as physiological saline can be shielded from entering the ablation site, so as to avoid the measurement accuracy of the resistance value between the first electrode 111 and the second electrode 211 during ablation, thereby affecting the ablation effect.
  • an arrangement of the shielding side eave 115 is as follows: as shown in FIG.
  • another arrangement of the shielding side eaves 115 is as follows: as shown in FIG. 4 , there are multiple shielding side eaves 115 , and the plurality of shielding side eaves 115 are arranged along the extending direction of the first protective sheath 113 and in sequence stitching.
  • the electrode 111 and/or the first magnetic member 112 is provided with a wire laying groove 120 for accommodating the wire 118, and the wire 118 is used to connect with the electrode 111; or, the wire 118 will be used for laying the wire
  • the wire laying groove 120 is arranged on the inner wall of the first protective sheath 113 .
  • the second electrode tip 210 includes a second protective sheath 214 , and the second electrode 211 is disposed on the second protective sheath 214 ; wherein the second electrode tip 210 includes The developing member 213, the developing member 213 is disposed on the second protective sheath 214, so as to mark the position of the second electrode end 210 by the developing member 213; and/or, the second electrode 211 is made of a metal developing material, and the metal developing material includes At least one of the following materials: platinum, platinum-based alloy, tantalum, gold-plated beryllium bronze; and/or, the second protective sheath 214 is made of a developing material, and the developing material is made of barium sulfate (BaSO4).
  • BaSO4 barium sulfate
  • the first electrode assembly 100 includes a plurality of first electrode tips 110
  • the second electrode assembly 200 includes a plurality of second electrode tips 210 .
  • the ablation device in this embodiment ablation principle of the tissue to be ablated 340 , and can reflect the ablation range 330 of the ablation device.
  • the plurality of second magnetic members 212 and the plurality of second electrodes 211 are sleeved on the second protective sheath 214;
  • the extension directions of the protective sheaths are staggered, so that the plurality of second electrodes 211 are arranged at intervals, that is, each second magnetic member 212 is used to separate the corresponding two second electrodes 211 .
  • the plurality of second magnetic members 212 and the plurality of second electrodes 211 are all annular structures, or have cross-sectional structures such as polygonal, V-shaped, D-shaped, and arched.
  • the cross section of the second electrode 211 is a polygon, for example, a square.
  • the developing member 213 , the second electrode 211 with a developing function, and the second protective sheath 214 with a developing function can indicate the position of the second electrode assembly 200 when it enters the ablation site.
  • the number of the developing members 213 on the second electrode end 210 is 3-6, and the number of the developing members 213 may be set independently or the second electrode 211 may have a developing function.
  • the outer walls of the developing member 213 and the second protective sheath 214 are flush to prevent damage to the patient during the operation.
  • the developing member 213 may be absent, or there may be multiple developing members 213, and the multiple developing members 213 are arranged at intervals along the extending direction of the second protective sheath 214; and/or, the outer surface of the second protective sheath 214
  • the first surface portion and the second surface portion connected to the first surface portion are formed by dividing into a portion corresponding to the developing member 213.
  • the first surface portion is a concave structure, and the developing member 213 is sleeved on the first surface portion.
  • the developing member 213 The outer surface is flush with the second surface portion or lower than the second surface portion.
  • the first electrode assembly 100 is first fixed on the epicardium through the positioning member, then the second electrode assembly 200 enters the heart, and the second electrode assembly 200 is placed in the endocardium through the indication of the developing member 213.
  • the first pair of magnetic parts, the second pair of magnetic parts and the third pair of magnetic parts located at the first electrode end 110 and the second electrode end 210 are turned on synchronously and sequentially.
  • two sets of electrodes Complete initial positioning. After completing the initial positioning, the two electrode assemblies then turn on the remaining magnetic parts in pairs to complete the final positioning.
  • each pair of electrodes is relatively independent, that is, the number of working electrodes can be controlled.
  • the first electrode 111 has an electrode surface 1110 facing the tissue to be ablated
  • the protective sheath 113 has a protective sheath surface 1130 facing the tissue to be ablated; wherein, the electrode surface 1110 is located on the protective sheath Face 1130 is near the side of the tissue to be ablated.
  • first electrodes 111 there are multiple first electrodes 111, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; between the electrode surfaces 1110 of the multiple first electrodes 111 and the protective sheath surface 1130
  • the minimum distances are the same.
  • the value range of the minimum distance between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is 0-0.5 mm.
  • the existence of this height difference can make the first electrode 111 fully contact the surface to be ablated to ensure the ablation effect.
  • the height difference between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is preferably 0.2 mm.
  • the electrode surface 1110 and the protective sheath surface 1130 are both flat surfaces.
  • the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; At least one of the first electrodes 111 in the 111 is provided with a cooling hole 1112 for circulating a cooling fluid; and/or a cooling pipe for circulating a cooling fluid is provided in the first protective sheath 113 .
  • the cooling holes 1112 are provided for local cooling during the ablation process, so as to protect other parts other than the ablation site from being damaged. By providing cooling channels, cooling can be performed on the sides of the electrodes.
  • At least one of the plurality of first electrodes 111 is provided with 1 to 4 cooling holes 1112 .
  • the number of cooling holes on each first electrode 111 is 0-4 to ensure temperature control during ablation.
  • the present disclosure also provides a radio frequency ablation device.
  • 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 .
  • the radio frequency host 310 is provided with a display screen 313 , and the display screen 313 is used to display the measured values of the tissue to be ablated between the two corresponding first electrodes 111 and the second electrodes 211 . Impedance and/or RF power.
  • the radio frequency host 310 is further provided with an ablation interface 311, the first electrode assembly 100 and the second electrode assembly 200 each include a plurality of lead assemblies, and each lead assembly includes a lead connector and a plurality of parallel connection connected to the lead connector. Lead wires, each lead wire is used to connect with the corresponding electrode; the ablation interface 311 has a first ablation interface part and a second ablation interface part, and the first ablation interface part has a plurality of lead wires for inserting the plurality of lead wires of the first electrode assembly 100.
  • the second ablation interface part has a plurality of second ablation interfaces for inserting a plurality of lead wires of the second electrode assembly 200, so as to communicate with the corresponding The first electrode and corresponding second electrode 211 provide suitable radio frequency power.
  • each electromagnet assembly includes an electromagnetic joint and a plurality of electromagnetic wires connected in parallel with the electromagnetic joint, and each electromagnetic wire is used to connect with 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 a plurality of first magnetic interfaces for inserting a plurality of electromagnetic joints of the first electrode assembly 100 , and the second electromagnetic interface part has a plurality of electromagnetic joints for inserting a plurality of electromagnetic joints of the second electrode assembly 200 a plurality of second magnetic interfaces, so as to supply power to the corresponding first magnetic member 112 and the corresponding second magnetic member 212 through each of the first magnetic An attraction force is generated between the second magnetic members 212 .
  • the electrode assembly includes an electrode tip 110 , the electrode tip 110 includes a first protective sheath 113 , and a first electrode 111 and a filling member 116 disposed in the first protective sheath 113 , through the filling member 116
  • the first electrode 111 is squeezed to move the first electrode 111 toward the tissue to be ablated, so that the first electrode 111 can fit with the inner wall of the first protective sheath 113, and the corresponding position of the first protective sheath 113
  • the outer wall is attached to the corresponding tissue to be ablated, so as to ensure that the first electrode 111 can better act on the corresponding tissue to be ablated and ensure the ablation effect; it can be seen that the use of this electrode assembly can solve the medical interventional ablation device in the prior art The problem of unsatisfactory ablation effect.
  • the ablation device includes a first electrode assembly having a first electrode tip and a second electrode assembly having a second electrode tip.
  • the first electrode assembly and the second electrode assembly can be used independently, and the first electrode tip includes a first protective sheath and a plurality of first electrodes disposed on the first protective sheath;
  • An electrode is arranged at intervals along the extension direction of the first protective sheath, that is, a plurality of first electrodes act on the epicardial tissue at the same time to form a complete ablation line.
  • the protective sheath is made of flexible material, it can solve the problem of existing surgical instruments. The angle of use is limited and the surgical operation is inconvenient.
  • the first electrode and the second electrode of the ablation device are arranged opposite to each other, so that the tissue to be ablated located between the first electrode and the second electrode is ablated by the first electrode and the second electrode.
  • 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, to achieve Simultaneously ablate the epicardium and endocardium to achieve a good ablation effect, solve the problem that the energy of medical interventional ablation is constant, and the output power cannot be adjusted according to the ablation effect in a timely manner, resulting in overburning or wall impermeability and cardiac surgery is dynamic ablation, but surgery The ablation trauma is relatively large and the postoperative recovery is slow; thereby achieving a good ablation effect and improving ablation efficiency; it can be seen that the use of the ablation device can solve the problem of unsatisfactory ablation effect of the ablation device in the prior
  • the ablation device of the present disclosure includes the above-mentioned electrode assembly, so the ablation device has at least the same technical effect as the electrode assembly.
  • the radio frequency ablation device of the present disclosure includes the above-mentioned ablation device, so the radio frequency ablation device has at least the same technical effect as the ablation device.
  • 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 , the first electrode end The head 110 includes a first protective sheath 113 , a first electrode 111 and a filling member 116 .
  • the first electrode 111 is arranged in the first protective sheath 113 ;
  • the first electrode 111 in a protective sheath 113 is pressed toward the site to be ablated;
  • the second electrode assembly 200 includes a second electrode tip 210, the second electrode tip 210 includes a second electrode 211, and the second electrode 211 and the first electrode
  • An electrode 111 is disposed opposite to each other to ablate the site to be ablated between the first electrode 111 and the second electrode 211 through the first electrode 111 and the second electrode 211 .
  • 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, and the first electrode tip 110 includes a first protective sheath 113 and The first electrode 111 and the filler 116 are arranged in the first protective sheath 113, and the first electrode 111 is squeezed by the filler 116 to move the first electrode 111 toward the site to be ablated, so that the first electrode 111 can interact with the site to be ablated.
  • the second electrode assembly 200 includes a second electrode tip 210, and the second electrode tip 210 includes a second electrode 211 arranged opposite to the first electrode 111, so as to be located in the opposite direction by the first electrode 111 and the second electrode 211.
  • the site to be ablated between the first electrode 111 and the second electrode 211 is ablated.
  • 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 heart, respectively membrane to achieve simultaneous epicardium and endocardium ablation for good ablation results. It can be seen that the use of the ablation device can solve the problem that the ablation effect of the ablation device in the prior art is not ideal.
  • the ablation device in the present disclosure can realize hybrid ablation of internal and surgical techniques. This technique has little trauma, which solves the problems of large trauma and slow recovery in the prior art for surgical ablation. Simultaneous ablation adjusts the output power by testing the actual impedance between tissues, which is accurate and safe, and the machine alarms when the impedance reaches a certain resistance value to complete the ablation to avoid excessive ablation.
  • 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 adjust the first electrode 111 and the corresponding second electrode 211 by testing the impedance between the first electrode 111 and the corresponding second electrode 211 .
  • the ablation is performed by radio frequency energy between the electrode 111 and the second electrode 211 .
  • the machine alarms that the ablation is completed to avoid excessive ablation, so as to solve the problem that the unilateral ablation depth of the interventional ablation in the prior art is limited and it is difficult to guarantee the tissue It solves the problem of complete dehydration and degeneration from the inside to the outside, and solves the problem that the radio frequency power is not easy to control. Low power will cause incomplete ablation, and excessive power will cause excessive ablation, tissue necrosis and even burn through and leakage.
  • the impedance of the tissue to be ablated between the electrodes changes from low to high; in the first stage of ablation, the impedance of the tissue to be ablated between the electrodes gradually increases, and the RF power remains unchanged to accelerate the intracellular molecules. Vibration; in the second stage of ablation, as the impedance of the ablated tissue between the electrodes increases, the radio frequency power gradually increases, and when the impedance of the ablated tissue between the electrodes increases to its first preset value, the radio frequency power It also increases to its preset maximum value.
  • 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 RF power gradually increases. It is decreased to ensure the completeness of ablation and prevent the phenomenon of scarring on the tissue surface or damage to the patient caused by the high power output of the radio frequency; until the impedance of the ablated tissue between the electrodes increases to its second preset value, the end of the ablation is prompted.
  • first electrodes 111 and multiple second electrodes 211 there are multiple first electrodes 111 and multiple second electrodes 211, and multiple first electrodes 111 and multiple second electrodes 211 are arranged in cooperation with each other; by setting multiple first electrodes 111 and multiple second electrodes 211 Electrodes 111 and multiple second electrodes 211, so that multiple first electrodes 111 and multiple second electrodes 211 can simultaneously act on their corresponding parts to be ablated, so as to ensure ablation effect and improve ablation efficiency;
  • the first electrodes 111 are arranged at intervals to avoid mutual influence between two adjacent first electrodes 111 .
  • the plurality of second electrodes 211 are arranged at intervals to avoid mutual influence between two adjacent second electrodes 211 .
  • the first protective sheath 113 is strip-shaped, and the plurality of first electrodes 111 are arranged at intervals along the extending direction of the first protective sheath 113; to form a complete ablation line.
  • the first protective sheath 113 is tubular, and the plurality of first electrodes 111 are disposed in the lumen of the first protective sheath 113 .
  • the number of the first electrodes 111 is 2 to 10.
  • filler 116 is a flexible mass.
  • an arrangement of the filler 116 is as follows: as shown in FIG. 2 , the filler 116 is strip-shaped, and the filler 116 extends along the extending direction of the first protective sheath 113 .
  • the filler 116 is an airbag structure, so as to form a pressing effect on the plurality of first electrodes 111 when the airbag structure is inflated and expanded.
  • another arrangement of the fillers 116 is as follows: there are multiple fillers 116 , and the multiple fillers 116 are arranged at intervals along the extending direction of the first protective sheath 113 ; the multiple fillers 116 and the multiple The electrodes 111 are arranged in a one-to-one correspondence, so that each filler 116 can form a pressing effect on the corresponding first electrode 111; In order to realize that each filler 116 forms a pressing effect on the corresponding first electrode 111, each first electrode 111 moves in a direction close to the corresponding part to be ablated.
  • each filling member 116 is an airbag structure, so that when the airbag structure is inflated and inflated, a pressing effect is formed on the corresponding first electrode 111 .
  • the first protective sheath 113 is provided with an opening structure for avoiding the first electrode 111, so that part of the structure of the first electrode 111 is protruded from the cavity of the first protective sheath 113 through the opening structure, so that, This part of the electrode structure extending out of the cavity of the first protective sheath 113 can be in direct contact with the corresponding part to be ablated, so that this part of the electrode structure can better act on its corresponding part to be ablated, so as to further ensure the ablation effect and improve the Ablation efficiency.
  • a setting form of the opening structure is: when there are multiple first electrodes 111 , the opening structure includes multiple avoidance openings, and the multiple avoidance openings correspond to the multiple first electrodes 111 one-to-one so that the part of the structure of each first electrode 111 protrudes to the outside of the first protective sheath 113 through the corresponding avoidance holes, so that the part of the structure of each first electrode 111 protruding from the outside of the first protective sheath 113 is Can be in direct contact with the corresponding site to be ablated.
  • the opening structure is a strip-shaped opening
  • the strip-shaped openings are spaced along the extending direction of the first protective sheath 113
  • the partial structures of the plurality of first electrodes 111 pass through the strips.
  • the shaped opening protrudes to the outside of the first protective sheath 113 .
  • the second electrode tip 210 includes a second protective sheath, and a plurality of second electrodes 211 are sleeved on the second protective sheath; wherein, the plurality of first electrodes 111 and the plurality of second electrodes 211 are arranged in cooperation with each other.
  • the second protective sheath is strip-shaped, and the plurality of second electrodes 211 are arranged at intervals along the extending direction of the second protective sheath; that is, the plurality of second electrodes 211 simultaneously act on the corresponding parts to be ablated to form A complete ablation line.
  • the first electrode tip 110 further includes a first magnetic member 112
  • the second electrode tip 210 includes a second magnetic member 212
  • the first magnetic member 112 and the second magnetic member 212 cooperate with each other, so that the An electrode tip 110 and a second electrode tip 210 are relatively fixed, so that the first electrode 111 of the first electrode tip 110 can be disposed opposite to the corresponding second electrode 211 of the second electrode tip 210 .
  • first magnetic members 112 and second magnetic members 212 there are multiple first magnetic members 112 and second magnetic members 212 , the multiple first magnetic members 112 are arranged at intervals along the extending direction of the first electrode tip 110 , and the multiple second magnetic members 212 are arranged along the extending direction of the first electrode tip 110 .
  • the extending directions of the electrode terminals 210 are arranged at intervals to ensure the overall fixing effect between the first electrode terminal 110 and the second electrode terminal 210 .
  • each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs.
  • the magnetic force of the magnetic piece is controllable and adjustable, a small magnetic force is used in the initial positioning, and a large magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible in the initial positioning and firm in the final positioning, so as to ensure the electrode assembly.
  • the plurality of first magnetic members 112 are all disposed in the lumen of the first protective sheath 113 .
  • the first magnetic member 112 is an electromagnet; and/or the second magnetic member 212 is an electromagnet.
  • the plurality of first magnetic members 112 are all disposed in the first protective sheath 113 , and the plurality of first magnetic members 112 are disposed at intervals along the extending direction of the first protective sheath 113 .
  • the plurality of first magnetic members 112 and the plurality of first electrodes 111 are alternately arranged along the extending direction of the first protective sheath 113 , so that the plurality of first electrodes 111 are arranged at intervals, that is, each first magnetic member 112 is used to separate the plurality of first electrodes 111 .
  • the corresponding two first electrodes 111 are turned on.
  • each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs.
  • the magnetic force of the magnetic parts is controllable and adjustable. A small magnetic force is used in the initial positioning, and a larger magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible at the initial positioning and firm after the final positioning, so as to ensure the fit of the electrodes. , thereby ensuring the ablation effect.
  • the plurality of second magnetic members 212 are all sleeved on the second protective sheath, and the plurality of second magnetic members 212 are arranged at intervals along the extending direction of the second protective sheath.
  • the plurality of second magnetic members 212 and the plurality of second electrodes 211 are alternately arranged along the extending direction of the second protective sheath, so that the plurality of second electrodes 211 are arranged at intervals, that is, each second magnetic member 212 is used to separate The corresponding two second electrodes 211 .
  • the opposite sides of the first protective sheath 113 are provided with shielding side eaves 115 to form shielding protection for the plurality of first electrodes 111 and the plurality of first magnetic members 112 inside the first protective sheath 113 . It can prevent the blood in the epicardial tissue from entering the area between the first protective sheath 113 and the epicardium during the ablation process and affect the tightness between the first protective sheath 113 and the epicardium, and avoid the first protective sheath 113 during ablation. The measurement accuracy of the resistance value between the electrode 111 and the second electrode 211 affects the ablation effect.
  • the shielding side eave 115 by setting the shielding side eave 115, the tissue fluid outside the ablation line and liquids such as physiological saline can be shielded from entering the ablation site, so as to avoid the measurement accuracy of the resistance value between the first electrode and the second electrode during ablation, thereby affecting the ablation effect.
  • an arrangement of the shielding side eave 115 is as follows: as shown in FIG.
  • another arrangement of the shielding side eaves 115 is as follows: as shown in FIG. 4 , there are multiple shielding side eaves 115 , and the plurality of shielding side eaves 115 are arranged along the extending direction of the first protective sheath 113 and in sequence stitching.
  • the first electrode 111 and/or the first magnetic member 112 is provided with a wire laying groove 120 for accommodating the wire 118, and the wire 118 is used to connect with the first electrode 111;
  • the wire laying groove 120 for laying the wire 118 is provided on the inner wall of the first protective sheath 113 .
  • the second electrode tip 210 includes a second protective sheath 214 , and the second electrode 211 is disposed on the second protective sheath 214 ; wherein the second electrode tip 210 includes The developing member 213, the developing member 213 is disposed on the second protective sheath 214, so as to mark the position of the second electrode end 210 by the developing member 213; and/or, the second electrode 211 is made of a metal developing material, and the metal developing material includes At least one of the following materials: platinum, platinum-based alloy, tantalum, gold-plated beryllium bronze; and/or, the second protective sheath 214 is made of a developing material, and the developing material is made of barium sulfate (BaSO4).
  • BaSO4 barium sulfate
  • the plurality of second magnetic members 212 and the plurality of second electrodes 211 are sleeved on the second protective sheath 214;
  • the extension directions of the protective sheaths are staggered, so that the plurality of second electrodes 211 are arranged at intervals, that is, each second magnetic member 212 is used to separate the corresponding two second electrodes 211 .
  • the plurality of second magnetic members 212 and the plurality of second electrodes 211 are both annular structures. Or polygonal, V-shaped, D-shaped, arched and other cross-sectional structures. As shown in FIG. 19 , the cross section of the second electrode 211 is a polygon, for example, a square.
  • the developing member 213 , the second electrode 211 with a developing function, and the second protective sheath 214 with a developing function can indicate the position of the second electrode assembly 200 when it enters the ablation site.
  • the number of the developing members 213 on the second electrode end 210 is 3-6, and the number of the developing members 213 may be set independently or the second electrode 211 may have a developing function.
  • the outer walls of the developing member 213 and the second protective sheath 214 are flush to prevent damage to the patient during the operation.
  • the developing member 213 may be absent, or there may be multiple developing members 213, and the multiple developing members 213 are arranged at intervals along the extending direction of the second protective sheath 214; and/or, the outer surface of the second protective sheath 214
  • the first surface portion and the second surface portion connected to the first surface portion are formed by dividing into a portion corresponding to the developing member 213.
  • the first surface portion is a concave structure, and the developing member 213 is sleeved on the first surface portion.
  • the developing member 213 The outer surface is flush with the second surface portion or lower than the second surface portion.
  • the first electrode assembly 100 is first fixed on the epicardium through the positioning member, then the second electrode assembly 200 enters the heart, and the second electrode assembly 200 is placed in the endocardium through the indication of the developing member 213.
  • the first pair of magnetic parts, the second pair of magnetic parts and the third pair of magnetic parts located at the first electrode end 110 and the second electrode end 210 are turned on synchronously and sequentially.
  • two sets of electrodes Complete initial positioning. After completing the initial positioning, the two electrode assemblies then turn on the remaining magnetic parts in pairs to complete the final positioning.
  • each pair of electrodes is relatively independent, that is, the number of working electrodes can be controlled.
  • the first electrode 111 has an electrode surface 1110 disposed toward the site to be ablated, and the first protective sheath 113 has a protective sheath surface 1130 disposed toward the site to be ablated; wherein, the electrode surface 1110 is located on the The protective sheath surface 1130 is close to the side of the site to be ablated.
  • first electrodes 111 there are multiple first electrodes 111, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; between the electrode surfaces 1110 of the multiple first electrodes 111 and the protective sheath surface 1130
  • the minimum distances are the same.
  • the value range of the minimum distance between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is 0-0.5 mm.
  • the existence of this height difference can make the first electrode 111 fully contact the surface to be ablated to ensure the ablation effect.
  • the height difference between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is preferably 0.2 mm.
  • the electrode surface 1110 and the protective sheath surface 1130 are both flat surfaces.
  • the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; At least one of the first electrodes 111 in the 111 is provided with a cooling hole 1112 for circulating a cooling fluid; and/or a cooling pipe for circulating a cooling fluid is provided in the first protective sheath 113 .
  • the cooling holes 1112 are provided for local cooling during the ablation process, so as to protect other parts other than the ablation site from being damaged. By providing cooling channels, cooling can be performed on the sides of the electrodes.
  • At least one of the plurality of first electrodes 111 is provided with 1 to 4 cooling holes 1112 .
  • the number of cooling holes on each first electrode 111 is 0-4 to ensure temperature control during ablation.
  • the present disclosure also provides a radio frequency ablation device.
  • 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 .
  • the radio frequency host 310 is provided with a display screen 313 , and the display screen 313 is used to display the measured values of the tissue to be ablated between the two corresponding first electrodes 111 and the second electrodes 211 . Impedance and/or RF Power.
  • the radio frequency host 310 is further provided with an ablation interface 311, the first electrode assembly 100 and the second electrode assembly 200 each include a plurality of lead assemblies, and each lead assembly includes a lead connector and a plurality of parallel connection connected to the lead connector. Lead wires, each lead wire is used to connect with the corresponding electrode; the ablation interface 311 has a first ablation interface part and a second ablation interface part, and the first ablation interface part has a plurality of lead wires for inserting the plurality of lead wires of the first electrode assembly 100.
  • the second ablation interface part has a plurality of second ablation interfaces for inserting a plurality of lead wires of the second electrode assembly 200, so as to communicate with the corresponding The first electrode 111 and the corresponding second electrode 211 provide suitable radio frequency power.
  • each electromagnet assembly includes an electromagnetic joint and a plurality of electromagnetic wires connected in parallel with the electromagnetic joint, and each electromagnetic wire is used to connect with 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 a plurality of first magnetic interfaces for inserting a plurality of electromagnetic joints of the first electrode assembly 100 , and the second electromagnetic interface part has a plurality of electromagnetic joints for inserting a plurality of electromagnetic joints of the second electrode assembly 200 a plurality of second magnetic interfaces, so as to supply power to the corresponding first magnetic member 112 and the corresponding second magnetic member 212 through each of the first magnetic An attraction force is generated between the second magnetic members 212 .
  • the ablation device in this embodiment ablation principle of the tissue to be ablated 340 , and can reflect the ablation range 330 of the ablation device.
  • the electrode assembly includes a first electrode tip 110, the first electrode tip 110 includes a first protective sheath 113, and a first electrode 111 and a filler 116 disposed in the first protective sheath 113,
  • the first electrode 111 is squeezed by the filler 116 to move the first electrode 111 toward the tissue to be ablated, so that the first electrode 111 can fit with the inner wall of the first protective sheath 113, and the first electrode 111 at the corresponding position
  • the outer wall of the protective sheath 113 is attached to the corresponding tissue to be ablated, so as to ensure that the first electrode 111 can better act on the corresponding tissue to be ablated and ensure the ablation effect; it can be seen that the use of this electrode assembly can solve the problems of internal medicine in the prior art.
  • the problem of unsatisfactory ablation effect of interventional ablation device is disposed in the first protective sheath 113, and a first electrode 111 and a filler 116 disposed in the first protective sheath
  • the ablation device includes a first electrode assembly having a first electrode tip and a second electrode assembly having a second electrode tip.
  • the first electrode assembly and the second electrode assembly can be used independently, and the first electrode tip includes a first protective sheath and a plurality of first electrodes disposed on the first protective sheath;
  • An electrode is arranged at intervals along the extension direction of the first protective sheath, that is, a plurality of first electrodes act on the epicardial tissue at the same time to form a complete ablation line.
  • the protective sheath is made of flexible material, it can solve the problem of existing surgical instruments. The angle of use is limited and the surgical operation is inconvenient.
  • the first electrode and the second electrode of the ablation device are arranged opposite to each other, so that the tissue to be ablated located between the first electrode and the second electrode is ablated by the first electrode and the second electrode.
  • 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, to achieve Simultaneously ablate the epicardium and endocardium to achieve a good ablation effect, solve the problem that the energy of medical interventional ablation is constant, and the output power cannot be adjusted according to the ablation effect in a timely manner, resulting in overburning or wall impermeability and cardiac surgery is dynamic ablation, but surgery The ablation trauma is relatively large and the postoperative recovery is slow; thereby achieving a good ablation effect and improving ablation efficiency; it can be seen that the use of the ablation device can solve the problem of unsatisfactory ablation effect of the ablation device in the prior
  • the radio frequency ablation device of the present disclosure includes the above-mentioned ablation device, so the radio frequency ablation device has at least the same technical effect as the ablation device.
  • spatially relative terms such as “on”, “over”, “on the surface”, “above”, etc., may be used herein to describe what is shown in the figures.
  • spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “above” or “over” other devices or features would then be oriented “below” or “over” the other devices or features under other devices or constructions”.
  • the exemplary term “above” can encompass both an orientation of "above” and “below.”
  • the device may also be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptions used herein interpreted accordingly.

Abstract

An electrode assembly, an ablation device and a radiofrequency ablation apparatus. The electrode assembly comprises a first electrode tip (110), wherein the first electrode tip (110) comprises a first protective sheath (113), and a first electrode (111) and a filling member (116), which are arranged inside the first protective sheath (113), the first electrode (111) is pressed by the filling member (116) so as to move the first electrode (111) towards tissue (340) to be ablated, then the first electrode (111) can be attached to an inner wall of the first protective sheath (113), and an outer wall of the first protective sheath (113) at the corresponding position is attached to the corresponding tissue (340) to be ablated, such that it is guaranteed that the first electrode (111) can successfully act on the corresponding tissue (340) to be ablated, and an ablation effect is guaranteed. By means of a first electrode (111), the problems in the prior art of an ablation device not being firmly attached to tissue (340) to be ablated, the tissue (340) to be ablated being prone to disengaging, and an ablation effect not being ideal can be solved.

Description

电极组件、消融装置和射频消融设备Electrode assemblies, ablation devices, and radiofrequency ablation devices
相关申请的交叉引用CROSS-REFERENCE TO RELATED APPLICATIONS
本公开是以申请号为202110026567.6,申请日为2021年1月8日,公开名称为“电极组件、消融装置和射频消融设备”的中国专利申请和申请号为202120046531.X,申请日为2021年1月8日,公开名称为“消融装置和射频消融设备”的中国专利申请为基础,并主张其优先权,该中国专利申请的公开内容在此作为整体引入本公开中。The present disclosure is based on a Chinese patent application with an application number of 202110026567.6, an application date of January 8, 2021, and a public name of "electrode assembly, ablation device and radiofrequency ablation device" and an application number of 202120046531.X, and the application date of 2021. On January 8, a Chinese patent application entitled "Ablation Device and Radio Frequency Ablation Apparatus" was published as the basis and claimed priority, the disclosure of which is hereby incorporated into the present disclosure in its entirety.
技术领域technical field
本公开涉及医疗器械领域,具体而言,涉及一种电极组件、消融装置和射频消融设备。The present disclosure relates to the field of medical devices, and in particular, to an electrode assembly, an ablation device, and a radiofrequency ablation device.
背景技术Background technique
消融是治疗房颤的常见措施,其原理是在心脏组织创建一条或多条消融线,引起组织坏死,切断不正常的电信号传导,用于房颤的治疗。Ablation is a common measure for the treatment of atrial fibrillation. The 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.
当前的消融治疗分为外科消融和内科介入消融,外科消融的特点是疗效优,术后复发率低,但是其显而易见的缺点是创伤较大,术后恢复慢。内科的介入式消融因为创伤小、恢复快受到越来越多患者的青睐,但是内科消融是点状消融,其最大的弊端便是很难形成一条完整的消融线;且消融时是单侧贴壁式工作,消融深度有限,很难保证组织由内至外完全脱水、变性,手术中消融功率小时消融不彻底,而功率大了又不易掌控,有消融过度组织坏死甚至烧穿、烧漏现象,故内科介入式消融的成功率较外科低好多。The current ablation treatment is divided into surgical ablation and medical interventional ablation. Surgical ablation is characterized by excellent curative effect and low postoperative recurrence rate, but its obvious shortcomings are large trauma and slow postoperative recovery. Medical interventional ablation is favored by more and more patients because of its small trauma and fast recovery, but medical ablation is point ablation, and its biggest drawback is that it is difficult to form a complete ablation line; Wall work, the ablation depth is limited, and it is difficult to ensure complete dehydration and degeneration of the tissue from the inside to the outside. During the operation, the ablation power is small and the ablation is not complete, but the power is high and it is difficult to control. There are excessive ablation tissue necrosis or even burning through and burning leakage. Therefore, the success rate of medical interventional ablation is much lower than that of surgery.
发明内容SUMMARY OF THE INVENTION
本公开的主要目的在于提供一种电极组件、消融装置和射频消融设备,以解决现有技术中的消融装置与待消融组织贴合不牢固,容易脱开待消融组织且消融效果不理想的问题。The main purpose of the present disclosure is to provide an electrode assembly, an ablation device and a radio frequency ablation device, so as to solve the problems in the prior art that the ablation device is not firmly attached to the tissue to be ablated, the tissue to be ablated is easily detached, and the ablation effect is not ideal .
本公开第一方面提供一种电极组件,包括第一电极端头,所述第一电极端头包括:第一保护鞘;第一电极,所述第一电极设置在所述第一保护鞘内;填充件,所述填充件设置在所述第一保护鞘内,以通过所述填充件将所述第一保护鞘内的所述第一电极 朝向待消融组织挤压。A first aspect of the present disclosure provides an electrode assembly, including a first electrode tip, the first electrode tip comprising: a first protective sheath; and a first electrode, the first electrode is disposed in the first protective sheath ; a filling piece, the filling piece is arranged in the first protective sheath, so as to press the first electrode in the first protective sheath towards the tissue to be ablated through the filling piece.
在一些实施例的电极组件中,所述第一电极为多个,所述第一保护鞘为条形,多个所述第一电极沿所述第一保护鞘的延伸方向间隔布置。In the electrode assembly of some embodiments, there are a plurality of the first electrodes, the first protective sheath is strip-shaped, and the plurality of the first electrodes are arranged at intervals along the extending direction of the first protective sheath.
在一些实施例的电极组件中,所述填充件为条形,所述第一保护鞘为条形,所述填充件沿所述第一保护鞘的延伸方向延伸。In the electrode assembly of some embodiments, the filler is in the shape of a bar, the first protective sheath is in the shape of a bar, and the filler extends along the extending direction of the first protective sheath.
在一些实施例的电极组件中,所述填充件为多个,所述第一保护鞘为条形,多个所述填充件沿所述第一保护鞘的延伸方向间隔布置。In the electrode assembly of some embodiments, there are a plurality of the fillers, the first protective sheath is strip-shaped, and the plurality of the fillers are arranged at intervals along the extending direction of the first protective sheath.
在一些实施例的电极组件中,多个所述填充件和多个所述第一电极一一对应地设置,各个所述填充件均设置在相应的所述第一电极的远离所述待消融组织的一侧。In the electrode assembly of some embodiments, a plurality of the fillers and a plurality of the first electrodes are arranged in a one-to-one correspondence, and each of the fillers is arranged at a distance from the corresponding first electrode away from the to-be-ablated electrode. side of the tissue.
在一些实施例的电极组件中,多个所述第一电极的通电电路独立设置,以单独控制各个所述第一电极。In the electrode assembly of some embodiments, the energization circuits of the plurality of first electrodes are provided independently, so as to individually control each of the first electrodes.
在一些实施例的电极组件中,多个所述填充件的通气管路独立设置,以单独控制各个所述填充件的充气状态。In the electrode assembly of some embodiments, the ventilation lines of the plurality of fillers are independently provided, so as to individually control the inflation state of each of the fillers.
在一些实施例的电极组件中,所述填充件为气囊结构或者所述填充件为柔性块。In the electrode assembly of some embodiments, the filler is a balloon structure or the filler is a flexible block.
在一些实施例的电极组件中,所述第一保护鞘上设置有用于避让所述第一电极的开孔结构,以使所述第一电极的部分结构经所述开孔结构由所述第一保护鞘的腔体伸出。In the electrode assembly of some embodiments, the first protective sheath is provided with an opening structure for avoiding the first electrode, so that part of the structure of the first electrode can pass through the opening structure from the first electrode. The lumen of a protective sheath protrudes.
在一些实施例的电极组件中,所述第一电极为多个,所述开孔结构包括多个避让开孔,多个所述避让开孔与多个所述第一电极一一对应地设置,以使各个所述第一电极的部分结构通过相应的所述避让开孔伸出至所述第一保护鞘的外侧。In the electrode assembly of some embodiments, there are a plurality of the first electrodes, the opening structure includes a plurality of avoidance holes, and the plurality of avoidance holes are provided in a one-to-one correspondence with the plurality of the first electrodes , so that part of the structure of each of the first electrodes protrudes to the outside of the first protective sheath through the corresponding avoidance holes.
在一些实施例的电极组件中,所述第一电极为多个,所述开孔结构为条形开口,所述条形开口沿所述第一保护鞘的延伸方向间隔,多个所述第一电极的部分结构通过所述条形开口伸出至所述第一保护鞘的外侧。In the electrode assembly of some embodiments, there are a plurality of the first electrodes, the opening structure is a strip-shaped opening, and the strip-shaped openings are spaced along the extending direction of the first protective sheath, and a plurality of the first electrodes are formed. A part of the structure of an electrode protrudes to the outside of the first protective sheath through the strip-shaped opening.
本公开第二方面提供一种消融装置,包括第一电极组件和第二电极组件,其中,所述第一电极组件为本公开第一方面所述的电极组件,所述第二电极组件包括第二电极端头,所述第二电极端头包括第二电极,所述第二电极与所述第一电极相对设置,以通过所述第一电极和所述第二电极对位于所述第一电极和所述第二电极之间的待消融组织进行消融。A second aspect of the present disclosure provides an ablation device, including a first electrode assembly and a second electrode assembly, wherein the first electrode assembly is the electrode assembly described in the first aspect of the disclosure, and the second electrode assembly includes a first electrode assembly. Two-electrode terminal, the second electrode terminal includes a second electrode, and the second electrode is disposed opposite to the first electrode so as to be located on the first electrode through the pair of the first electrode and the second electrode The tissue to be ablated between the electrode and the second electrode is ablated.
在一些实施例的消融装置中,所述第二电极端头包括第二保护鞘,所述第二电极为多个,多个所述第二电极套设在所述第二保护鞘上;其中,多个所述第一电极和多 个所述第二电极相互配合地设置。In the ablation device of some embodiments, the second electrode tip includes a second protective sheath, the second electrodes are multiple, and the plurality of second electrodes are sheathed on the second protective sheath; wherein , a plurality of the first electrodes and a plurality of the second electrodes are arranged in cooperation with each other.
在一些实施例的消融装置中,所述消融装置还包括:消融电路,所述第一电极和所述第二电极均设置在所述消融电路上,以通过测试所述第一电极和相应的所述第二电极之间的阻抗调整所述第一电极和所述第二电极之间的射频能量来进行消融。In the ablation device of some embodiments, the ablation device further comprises: an ablation circuit, on which the first electrode and the second electrode are both disposed, so as to pass the test of the first electrode and the corresponding The impedance between the second electrodes modulates the radio frequency energy between the first electrode and the second electrode for ablation.
本公开第三方面还提供一种射频消融设备,包括射频主机和与所述射频主机连接的消融装置,其中,所述消融装置为本公开第二方面所述的消融装置。A third aspect of the present disclosure further provides a radio frequency ablation device, comprising a radio frequency host and an ablation device connected to the radio frequency host, wherein the ablation device is the ablation device described in the second aspect of the present disclosure.
应用本公开的技术方案,该电极组件包括第一电极端头,第一电极端头包括第一保护鞘以及设置在第一保护鞘内的第一电极和填充件,通过填充件对第一电极进行挤压以使第一电极朝向待消融组织移动,进而使第一电极能够与第一保护鞘的内壁贴合,而相对应的位置的第一保护鞘的外壁与相应的待消融组织贴合,从而保证第一电极能够较好地作用于相应的待消融组织,保证消融效果;可见,使用本电极组件能够解决现有技术中的消融装置与待消融组织贴合不牢固,容易脱开待消融组织且消融效果不理想的问题。Applying the technical solution of the present disclosure, the electrode assembly includes a first electrode tip, the first electrode tip includes a first protective sheath, a first electrode and a filling member disposed in the first protective sheath, and the first electrode is connected to the first electrode through the filling member. Squeeze to move the first electrode toward the tissue to be ablated, so that the first electrode can fit with the inner wall of the first protective sheath, and the outer wall of the first protective sheath at the corresponding position fits with the corresponding tissue to be ablated , so as to ensure that the first electrode can better act on the corresponding tissue to be ablated and ensure the ablation effect; it can be seen that the use of this electrode assembly can solve the problem that the ablation device in the prior art is not firmly attached to the tissue to be ablated, and it is easy to disengage the tissue to be ablated. Ablation of tissue and the problem of unsatisfactory ablation effect.
附图说明Description of drawings
构成本公开的一部分的说明书附图用来提供对本公开的进一步理解,本公开的示意性实施例及其说明用于解释本公开,并不构成对本公开的不当限定。在附图中:The accompanying drawings that constitute a part of the present disclosure are used to provide further understanding of the present disclosure, and the exemplary embodiments of the present disclosure and their descriptions are used to explain the present disclosure and do not constitute an improper limitation of the present disclosure. In the attached image:
图1示出了根据本公开的可选的一种电极组件(第一电极组件)的结构示意图;FIG. 1 shows a schematic structural diagram of an optional electrode assembly (first electrode assembly) according to the present disclosure;
图2示出了图1中的第一电极组件的纵向剖视结构图;FIG. 2 shows a longitudinal cross-sectional structural view of the first electrode assembly in FIG. 1;
图3示出了图1中的第一电极组件的具有遮挡侧檐的一种结构设置示意图;Fig. 3 is a schematic diagram showing a structural arrangement of the first electrode assembly in Fig. 1 with shielding side eaves;
图4示出了图1中的第一电极组件的具有遮挡侧檐的另一种结构设置示意图;FIG. 4 is a schematic diagram showing another structural arrangement of the first electrode assembly in FIG. 1 with shielding side eaves;
图5示出了图1中的第一电极组件的具有导线铺设槽的结构设置示意图;FIG. 5 shows a schematic diagram of the structural arrangement of the first electrode assembly in FIG. 1 with wire laying grooves;
图6示出了根据本公开的第一电极组件的另一个实施例的剖视图;6 shows a cross-sectional view of another embodiment of a first electrode assembly according to the present disclosure;
图7示出了根据本公开的可选的一种消融装置的第二电极组件的结构示意图;FIG. 7 shows a schematic structural diagram of a second electrode assembly of an optional ablation device according to the present disclosure;
图8示出了图7中的消融装置的第二电极组件的局部放大图;FIG. 8 shows a partial enlarged view of the second electrode assembly of the ablation device of FIG. 7;
图9示出了图8中的消融装置的第二电极组件的A部放大图;FIG. 9 shows an enlarged view of part A of the second electrode assembly of the ablation device of FIG. 8;
图10示出了根据本公开的可选的一种射频消融设备的射频主机的结构示意图;FIG. 10 shows a schematic structural diagram of a radio frequency host of an optional radio frequency ablation device according to the present disclosure;
图11示出了根据本公开的可选的一种射频消融设备的射频主机和消融装置之间的组装图;FIG. 11 shows an assembly diagram between a radio frequency host and an ablation device of an optional radio frequency ablation device according to the present disclosure;
图12示出了本公开中的消融装置对待消融组织进行消融处理时的原理图;FIG. 12 shows a schematic diagram of the ablation device in the present disclosure when the tissue to be ablated is ablated;
图13示出了本公开中的消融装置的一个实施例的第一电极和第二电极与待消融组织之间的配合图;13 shows a diagram of the cooperation between the first electrode and the second electrode and the tissue to be ablated in an embodiment of the ablation device in the present disclosure;
图14示出了本公开的消融装置的一种状态的消融原理图;FIG. 14 shows a schematic diagram of ablation in one state of the ablation device of the present disclosure;
图15示出了本公开的消融装置的另一种状态的消融原理图;FIG. 15 shows an ablation schematic diagram of another state of the ablation device of the present disclosure;
图16示出了本公开的射频消融设备的射频主机与第一电极组件和第二电极组件之间的接线原理图;FIG. 16 shows a schematic diagram of the wiring between the radio frequency host and the first electrode assembly and the second electrode assembly of the radio frequency ablation device of the present disclosure;
图17示出了本公开的消融装置的第一电极组件的第二个实施例的结构示意图;FIG. 17 shows a schematic structural diagram of the second embodiment of the first electrode assembly of the ablation device of the present disclosure;
图18示出了本公开的消融装置的第二电极组件的第二个实施例的结构示意图;FIG. 18 shows a schematic structural diagram of the second embodiment of the second electrode assembly of the ablation device of the present disclosure;
图19示出了本公开的消融装置的另一个实施例的第一电极和第二电极与待消融组织之间的配合图。FIG. 19 shows a diagram of the cooperation between the first electrode and the second electrode and the tissue to be ablated in another embodiment of the ablation device of the present disclosure.
其中,上述附图包括以下附图标记:Wherein, the above-mentioned drawings include the following reference signs:
100、第一电极组件;100. A first electrode assembly;
110、第一电极端头;111、第一电极;1110、电极面;1112、冷却孔;112、第一磁性件;113、第一保护鞘;1130、保护鞘面;115、遮挡侧檐;116、填充件;118、导线;110, the first electrode tip; 111, the first electrode; 1110, the electrode surface; 1112, the cooling hole; 112, the first magnetic part; 113, the first protective sheath; 1130, the protective sheath surface; 116, filler; 118, wire;
120、导线铺设槽;120. Conductor laying groove;
200、第二电极组件;200. A second electrode assembly;
210、第二电极端头;211、第二电极;212、第二磁性件;213、显影件;214、第二保护鞘;210, the second electrode tip; 211, the second electrode; 212, the second magnetic member; 213, the developing member; 214, the second protective sheath;
310、射频主机;311、消融接口;312、电磁接口;313、显示屏;320、消融电路;330、消融范围;340、待消融组织。310, radio frequency host; 311, ablation interface; 312, electromagnetic interface; 313, display screen; 320, ablation circuit; 330, ablation range; 340, tissue to be ablated.
具体实施方式Detailed ways
需要说明的是,在不冲突的情况下,本公开中的实施例及实施例中的特征可以相互组合。下面将参考附图并结合实施例来详细说明本公开。It should be noted that the embodiments of the present disclosure and the features of the embodiments may be combined with each other under the condition of no conflict. The present disclosure will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments.
本公开提供了一种电极组件,请参考图1至图19,该电极组件包括第一电极端头110,第一电极端头110包括第一保护鞘113、第一电极111以及填充件116,第一电极111设置在第一保护鞘113内;填充件116设置在第一保护鞘113内,以通过填充件116将第一保护鞘113内的第一电极111朝向待消融组织挤压。The present disclosure provides an electrode assembly, please refer to FIG. 1 to FIG. 19 , the electrode assembly includes a first electrode tip 110 , the first electrode tip 110 includes a first protective sheath 113 , a first electrode 111 and a filler 116 , The first electrode 111 is disposed in the first protective sheath 113 ; the filling member 116 is disposed in the first protective sheath 113 , so that the first electrode 111 in the first protective sheath 113 is pressed toward the tissue to be ablated by the filling member 116 .
在本公开的电极组件中,该电极组件包括第一电极端头110,第一电极端头110 包括第一保护鞘113以及设置在第一保护鞘113内的第一电极111和填充件116,通过填充件116对第一电极111进行挤压以使第一电极111朝向待消融组织移动,进而使第一电极111能够与第一保护鞘113的内壁贴合,而相对应的位置的第一保护鞘113的外壁与相应的待消融组织贴合,从而保证第一电极111能够较好地作用于相应的待消融组织,保证消融效果;可见,使用本电极组件能够解决现有技术中的内科介入式消融装置消融效果不理想的问题。In the electrode assembly of the present disclosure, the electrode assembly includes a first electrode tip 110, the first electrode tip 110 includes a first protective sheath 113, and a first electrode 111 and a filler 116 disposed in the first protective sheath 113, The first electrode 111 is squeezed by the filler 116 to move the first electrode 111 toward the tissue to be ablated, so that the first electrode 111 can fit with the inner wall of the first protective sheath 113, and the first electrode 111 at the corresponding position The outer wall of the protective sheath 113 is attached to the corresponding tissue to be ablated, so as to ensure that the first electrode 111 can better act on the corresponding tissue to be ablated and ensure the ablation effect; it can be seen that the use of this electrode assembly can solve the problems of internal medicine in the prior art. The problem of unsatisfactory ablation effect of interventional ablation device.
可选地,第一电极111为多个,第一保护鞘113为条形,多个第一电极111沿第一保护鞘113的延伸方向间隔布置;即通过多个第一电极111同时作用于其相对应的待消融组织,以形成一条完整的消融线,保证消融效果、提高消融效率;且使多个第一电极111间隔布置,可以避免相邻两个第一电极111之间相互影响。Optionally, there are multiple first electrodes 111 , the first protective sheath 113 is strip-shaped, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first protective sheath 113 ; that is, the multiple first electrodes 111 act on the The corresponding tissue to be ablated to form a complete ablation line, ensuring ablation effect and improving ablation efficiency; and arranging a plurality of first electrodes 111 at intervals can avoid mutual influence between two adjacent first electrodes 111 .
可选地,第一保护鞘113为管状,多个第一电极111均设置在第一保护鞘113的管腔内。Optionally, the first protective sheath 113 is tubular, and the plurality of first electrodes 111 are disposed in the lumen of the first protective sheath 113 .
在本实施例中,第一电极111为5至10个。In this embodiment, there are 5 to 10 first electrodes 111 .
在本实施例中,填充件116的一种设置方式为:如图2所示,填充件116为条形,第一保护鞘113为条形,填充件116沿保护鞘113的延伸方向延伸。可选地,填充件116为气囊结构,以在该气囊结构被充气而膨胀时,对多个第一电极111形成挤压作用。In this embodiment, an arrangement of the filling member 116 is as follows: as shown in FIG. Optionally, the filler 116 is an airbag structure, so as to form a pressing effect on the plurality of first electrodes 111 when the airbag structure is inflated and expanded.
在本实施例中,填充件116的另一种设置方式为:填充件116为多个,多个填充件116沿第一保护鞘113的延伸方向间隔布置;多个填充件116和多个第一电极111一一对应地设置,以使各个填充件116能够对相应的第一电极111形成挤压作用;各个填充件116均设置在相应的第一电极111的远离待消融组织的一侧,以实现各个填充件116对相应的第一电极111形成挤压作用时,各个第一电极111朝靠近相应的待消融组织的方向移动。可选地,各个填充件116均为气囊结构,以在该气囊结构被充气而膨胀时,对相应的第一电极111形成挤压作用。In this embodiment, another arrangement of the fillers 116 is as follows: there are multiple fillers 116 , and the multiple fillers 116 are arranged at intervals along the extending direction of the first protective sheath 113 ; the multiple fillers 116 and the multiple The electrodes 111 are arranged in a one-to-one correspondence, so that each filling member 116 can form a pressing effect on the corresponding first electrode 111; each filling member 116 is arranged on the side of the corresponding first electrode 111 away from the tissue to be ablated, In order to realize that each filler 116 has a pressing effect on the corresponding first electrode 111 , each first electrode 111 moves toward the direction of approaching the corresponding tissue to be ablated. Optionally, each filling member 116 is an airbag structure, so that when the airbag structure is inflated and inflated, a pressing effect is formed on the corresponding first electrode 111 .
在一些实施例中,多个第一电极111的通电电路独立设置,以单独控制各个第一电极111。In some embodiments, the energization circuits of the plurality of first electrodes 111 are independently set to individually control each of the first electrodes 111 .
在一些实施例中,两个相邻的第一电极的通电电路独立设置以形成消融电极对,以实现消融功能。In some embodiments, the energization circuits of two adjacent first electrodes are independently arranged to form an ablation electrode pair to achieve an ablation function.
在一些实施例中,多个填充件116的通气管路独立设置,以单独控制各个填充件116的充气状态。In some embodiments, the ventilation lines of the plurality of fillers 116 are provided independently to individually control the inflation state of each filler 116 .
可选地,第一保护鞘113上设置有用于避让第一电极111的开孔结构,以使第一电极111的部分结构经开孔结构由第一保护鞘113的腔体伸出,这样,伸出第一保护鞘113的腔体的这部分电极结构能够与相应的待消融组织直接接触,进而使这部分电极结构更好地作用于其相应的待消融组织,以进一步保证消融效果、提高消融效率。Optionally, the first protective sheath 113 is provided with an opening structure for avoiding the first electrode 111, so that part of the structure of the first electrode 111 is protruded from the cavity of the first protective sheath 113 through the opening structure, so that, This part of the electrode structure extending out of the cavity of the first protective sheath 113 can be in direct contact with the corresponding tissue to be ablated, so that this part of the electrode structure can better act on the corresponding tissue to be ablated, so as to further ensure the ablation effect and improve the Ablation efficiency.
在本实施例中,开孔结构的一种设置形式为:当第一电极111为多个,开孔结构包括多个避让开孔,多个避让开孔与多个第一电极111一一对应地设置,以使各个第一电极111的部分结构通过相应的避让开孔伸出至第一保护鞘113的外侧,进而使伸出第一保护鞘113外侧的各个第一电极111的部分结构均能够与相应的待消融组织直接接触。In this embodiment, a setting form of the opening structure is: when there are multiple first electrodes 111 , the opening structure includes multiple avoidance openings, and the multiple avoidance openings correspond to the multiple first electrodes 111 one-to-one so that the part of the structure of each first electrode 111 protrudes to the outside of the first protective sheath 113 through the corresponding avoidance holes, so that the part of the structure of each first electrode 111 protruding from the outside of the first protective sheath 113 is Direct contact with the corresponding tissue to be ablated is possible.
在本实施例中,开孔结构的另一种设置形式为:开孔结构为条形开口,条形开口沿第一保护鞘113的延伸方向间隔,多个第一电极111的部分结构通过条形开口伸出至第一保护鞘113的外侧。In this embodiment, another setting form of the opening structure is as follows: the opening structure is a strip-shaped opening, the strip-shaped openings are spaced along the extending direction of the first protective sheath 113 , and the partial structures of the plurality of first electrodes 111 pass through the strips. The shaped opening protrudes to the outside of the first protective sheath 113 .
本公开还提供了一种消融装置,该消融装置包括第一电极组件100和第二电极组件200,第一电极组件100为上述的电极组件,第一电极组件100的第一电极为第一电极111,即第一电极组件100的第一电极端头为第一电极端头110,第二电极组件200包括第二电极端头210,第二电极端头210包括第二电极211,第二电极211与第一电极111相对设置,以通过第一电极111和第二电极211对位于第一电极111和第二电极211之间的待消融组织进行消融。The present disclosure also provides an ablation device, the ablation device includes a first electrode assembly 100 and a second electrode assembly 200, the first electrode assembly 100 is the above-mentioned electrode assembly, and the first electrode of the first electrode assembly 100 is the first electrode 111, that is, the first electrode end of the first electrode assembly 100 is the first electrode end 110, the second electrode assembly 200 includes the second electrode end 210, the second electrode end 210 includes the second electrode 211, the second electrode The 211 is disposed opposite to the first electrode 111 to ablate the tissue to be ablated between the first electrode 111 and the second electrode 211 through the first electrode 111 and the second electrode 211 .
可选地,消融装置还包括消融电路320,第一电极111和第二电极211均设置在消融电路320上,以通过测试第一电极111和相应的第二电极211之间的阻抗调整第一电极111和第二电极211之间的射频能量来进行消融。Optionally, 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 adjust the first electrode 111 and the corresponding second electrode 211 by testing the impedance between the first electrode 111 and the corresponding second electrode 211 . The ablation is performed by radio frequency energy between the electrode 111 and the second electrode 211 .
在一些实施例中,第一电极组件100的第一电极端头110包括第一磁性件112,第二电极端头210包括第二磁性件212,第一磁性件112和第二磁性件212相配合,以使第一电极端头110和第二电极端头210相对固定。In some embodiments, the first electrode tip 110 of the first electrode assembly 100 includes a first magnetic member 112 , the second electrode tip 210 includes a second magnetic member 212 , and the first magnetic member 112 and the second magnetic member 212 are in phase with each other. Matching, so that the first electrode end 110 and the second electrode end 210 are relatively fixed.
在一些实施例中,第一磁性件112和第二磁性件212均为多个,第一电极端头110和第二电极端头210均为条形,多个第一磁性件112沿第一电极端头110的延伸方向间隔布置,多个第二磁性件212沿第二电极端头210的延伸方向间隔布置。In some embodiments, the first magnetic member 112 and the second magnetic member 212 are both multiple, the first electrode tip 110 and the second electrode tip 210 are both strip-shaped, and the multiple first magnetic members 112 are along the first The extending direction of the electrode tip 110 is arranged at intervals, and the plurality of second magnetic members 212 are arranged at intervals along the extending direction of the second electrode tip 210 .
在一些实施例中,第一电极111和第二电极211均为多个,多个第一磁性件112与多个第一电极111交错间隔设置,多个第二磁性件212与多个第二电极211交错间隔设置。In some embodiments, there are multiple first electrodes 111 and second electrodes 211 , multiple first magnetic members 112 and multiple first electrodes 111 are alternately arranged, multiple second magnetic members 212 and multiple second electrodes 111 The electrodes 211 are staggered and spaced apart.
在一些实施例中,相邻的第一电极111与第一磁性件112之间绝缘设置,相邻的第二电极211与第二磁性件212之间绝缘设置。In some embodiments, the adjacent first electrodes 111 and the first magnetic members 112 are provided in insulation, and the adjacent second electrodes 211 and the second magnetic members 212 are provided in insulation.
在一些实施例中,相邻的第一电极111与第一磁性件112之间的相对表面均喷涂有绝缘漆,或者相邻的第一电极111与第一磁性件112之间设置有绝缘隔板;相邻的第二电极211与第二磁性件212之间的相对表面均喷涂有绝缘漆,或者,相邻的第二电极211与第二磁性件212之间设置有绝缘隔板。绝缘隔板与保护鞘一体化设计或分体固定设定。In some embodiments, the opposite surfaces between the adjacent first electrodes 111 and the first magnetic members 112 are sprayed with insulating paint, or an insulating spacer is provided between the adjacent first electrodes 111 and the first magnetic members 112 The opposite surfaces between the adjacent second electrodes 211 and the second magnetic members 212 are all sprayed with insulating paint, or an insulating separator is provided between the adjacent second electrodes 211 and the second magnetic members 212 . Integrated design of insulating baffle and protective sheath or separate fixed setting.
在一些实施例中,第一磁性件112与第二磁性件212的外表面包覆有绝缘层。In some embodiments, the outer surfaces of the first magnetic member 112 and the second magnetic member 212 are covered with insulating layers.
在一些实施例中,第一电极111、第一磁性件112、第二电极211以及第二磁性件212均与独立的通电电路连接,以进行单独控制。In some embodiments, the first electrode 111 , the first magnetic member 112 , the second electrode 211 and the second magnetic member 212 are all connected to independent energization circuits for individual control.
在一些实施例中,第一电极111为多个,两个第一电极111的通电电路独立设置以形成标测电极对,以利用通电电路检测消融后的待消融组织340的电信号传递情况;和/或,第二电极211为多个,两个第二电极211的通电电路独立设置以形成标测电极对,以利用通电电路检测消融后的待消融组织340的电信号传递情况;和/或,第一电极111和第二电极211的通电电路独立设置以形成标测电极对,以利用通电电路检测待消融组织340消融后的电信号传递情况。标测时,形成标测电极对的两个第一电极111的极性不同,跨电压设置以形成电流,进而实现标测;形成标测电极对的两个第二电极211的极性不同,跨电压设置以形成电流,进而实现标测;形成标测电极对的第一电极111和第二电极211的极性不同,跨电压设置以形成电流,进而实现标测。In some embodiments, there are multiple first electrodes 111, and the energization circuits of the two first electrodes 111 are independently set to form a mapping electrode pair, so as to use the energization circuits to detect the transmission of electrical signals of the tissue to be ablated 340 after ablation; And/or, there are multiple second electrodes 211, and the energization circuits of the two second electrodes 211 are independently set to form a mapping electrode pair, so as to use the energization circuits to detect the electrical signal transmission of the tissue 340 to be ablated after ablation; and/or Alternatively, the energization 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 energization circuit to detect the transmission of electrical signals after the ablation of the tissue 340 to be ablated. During mapping, the polarities of the two first electrodes 111 forming the mapping electrode pair are different, and the voltage across the voltage is set to form a current, thereby realizing mapping; the polarities of the two second electrodes 211 forming the mapping electrode pair are different, The cross-voltage is set to form a current, and then the mapping is realized; the polarities of the first electrode 111 and the second electrode 211 that form the mapping electrode pair are different, and the cross-voltage is set to form a current, and then the mapping is realized.
使用时,将第一电极组件100和第二电极组件200分别用作心外膜电极和心内膜电极,以使第一电极组件100和第二电极组件200分别作用于心外膜和心内膜,以实现同时消融心外膜和心内膜,从而实现良好的消融效果。另外,本公开中的消融装置可以实现内、外科杂交式消融,此技术创伤小,解决了现有技术中外科消融创伤大、恢复慢的难题,同时又可以从心外膜和心内膜联合同步消融,通过测试组织间的实际阻抗调整输出功率,精确、安全,且阻抗达到一定阻值后机器报警消融完毕,避免过度消融。In 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 heart, respectively membrane to achieve simultaneous epicardium and endocardium ablation for good ablation results. In addition, the ablation device in the present disclosure can realize hybrid ablation of internal and surgical techniques. This technique has little trauma, which solves the problems of large trauma and slow recovery in the prior art for surgical ablation. Simultaneous ablation adjusts the output power by testing the actual impedance between tissues, which is accurate and safe, and the machine alarms when the impedance reaches a certain resistance value to complete the ablation to avoid excessive ablation.
另外,通过使第一电极111和第二电极211相对设置,可以实时测试第一电极111和第二电极211之间的阻抗,并根据实时检测的第一电极111和第二电极211之间的阻抗来调整第一电极111和第二电极211之间的射频能量来进行消融,且阻抗达到一定阻值后机器报警消融完毕,避免过度消融,以解决现有技术中介入式消融单侧消融 深度有限、难以保证组织由内至外完全脱水、变性的问题,同时解决了射频功率不易控制的问题,功率较小会造成消融不彻底,功率过大会造成消融过度,组织坏死甚至烧穿、烧漏现象。In addition, by arranging the first electrode 111 and the second electrode 211 opposite to each other, the impedance between the first electrode 111 and the second electrode 211 can be tested in real time, and according to the real-time detection of the impedance between the first electrode 111 and the second electrode 211 Impedance to adjust the radio frequency energy between the first electrode 111 and the second electrode 211 for ablation, and after the impedance reaches a certain resistance value, the machine alarms that the ablation is completed, to avoid excessive ablation, to solve the unilateral ablation depth of the interventional ablation in the prior art It is limited and difficult to ensure the complete dehydration and degeneration of the tissue from the inside to the outside. At the same time, it solves the problem that the radio frequency power is not easy to control. Low power will cause incomplete ablation, and excessive power will cause excessive ablation, tissue necrosis or even burn through and leakage. Phenomenon.
在消融过程中,电极间被消融组织的阻抗由低到高进行变化;在进行消融的第一阶段,电极间被消融组织的阻抗逐渐增大,射频功率保持不变,以加快细胞内分子的震动;在进行消融的第二阶段,随着电极间被消融组织的阻抗的增大,射频功率逐步增大,当电极间被消融组织的阻抗增大到其第一预设值时,射频功率也增大到其预设最大值,在此消融阶段,使得细胞迅速脱水以产生不可逆的变化;在进行消融的第三阶段,随着电极间被消融组织的阻抗的继续增大,射频功率逐步降低,以保证消融彻底性的同时预防因射频大功率输出而造成组织表面结痂或者损伤患者的现象;直至电极间被消融组织的阻抗增大到其第二预设值时,提示结束消融。During the ablation process, the impedance of the tissue to be ablated between the electrodes changes from low to high; in the first stage of ablation, the impedance of the tissue to be ablated between the electrodes gradually increases, and the RF power remains unchanged to accelerate the intracellular molecules. Vibration; in the second stage of ablation, as the impedance of the ablated tissue between the electrodes increases, the radio frequency power gradually increases, and when the impedance of the ablated tissue between the electrodes increases to its first preset value, the radio frequency power It 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 RF power gradually increases. It is decreased to ensure the completeness of ablation and prevent the phenomenon of scarring on the tissue surface or damage to the patient caused by the high power output of the radio frequency; until the impedance of the ablated tissue between the electrodes increases to its second preset value, the end of the ablation is prompted.
可选地,如图3和图8所示,第一电极111和第二电极211均为多个,多个第一电极111和多个第二电极211一一对应地设置;通过设置多个第一电极111和多个第二电极211,以使得多个第一电极111和多个第二电极211能够同时作用于其相对应的组织,以增强消融效果,并提高消融效率。可选地,第一电极端头110和第二电极端头210均为条形,多个第一电极111沿第一电极端头110的延伸方向间隔布置,多个第二电极211沿第二电极端头210的延伸方向间隔布置,各个第一电极111与其相对应地第二电极211成对地设置;即通过多个第一电极111和多个第二电极211同时作用于其相对应的组织,以形成一条完整的消融线,保证消融效果;且使多个第一电极111间隔布置,多个第二电极211间隔布置,可以避免相邻两个第一电极111之间、相邻两个第二电极211之间相互影响。Optionally, as shown in FIG. 3 and FIG. 8 , there are multiple first electrodes 111 and multiple second electrodes 211, and multiple first electrodes 111 and multiple second electrodes 211 are provided in one-to-one correspondence; The first electrode 111 and the plurality of second electrodes 211 enable the plurality of first electrodes 111 and the plurality of second electrodes 211 to act on their corresponding tissues at the same time, so as to enhance the ablation effect and improve the ablation efficiency. Optionally, the first electrode tip 110 and the second electrode tip 210 are both strip-shaped, the plurality of first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110 , and the plurality of second electrodes 211 are arranged along the second The extension directions of the electrode tips 210 are arranged at intervals, and each first electrode 111 and its corresponding second electrodes 211 are arranged in pairs; tissue, so as to form a complete ablation line and ensure the ablation effect; and the plurality of first electrodes 111 are arranged at intervals, and the plurality of second electrodes 211 are arranged at intervals, which can avoid the gap between two adjacent first electrodes 111 and between adjacent two electrodes 111. The second electrodes 211 influence each other.
在本实施例中,第一电极端头还包括第一磁性件112,第二电极端头210包括第二磁性件212,第一磁性件112和第二磁性件212相配合,以使第一电极端头110和第二电极端头210相对固定,进而使得第一电极端头110的第一电极111能够与第二电极端头210的相应的第二电极211相对设置。In this embodiment, the first electrode tip further includes a first magnetic member 112, the second electrode tip 210 includes a second magnetic member 212, and the first magnetic member 112 and the second magnetic member 212 cooperate to make the first The electrode tip 110 and the second electrode tip 210 are relatively fixed, so that the first electrode 111 of the first electrode tip 110 can be disposed opposite to the corresponding second electrode 211 of the second electrode tip 210 .
可选地,第一磁性件112和第二磁性件212均为多个,多个第一磁性件112沿第一电极端头110的延伸方向间隔布置,多个第二磁性件212沿第二电极端头210的延伸方向间隔布置,以保证第一电极端头110和第二电极端头210之间的整体固定效果。Optionally, there are multiple first magnetic members 112 and second magnetic members 212 , the multiple first magnetic members 112 are arranged at intervals along the extending direction of the first electrode tip 110 , and the multiple second magnetic members 212 are arranged along the extending direction of the first electrode tip 110 . The extending directions of the electrode terminals 210 are arranged at intervals to ensure the overall fixing effect between the first electrode terminal 110 and the second electrode terminal 210 .
可选地,每对第一磁性件112和第二磁性件212相对独立工作,即可以根据实际需求决定磁性件工作的数量。Optionally, each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs.
可选地,磁性件的磁力是可控并且可调整的,初定位时使用较小磁力,最终定位时使用较大磁力,使得内外两个电极组件初定位时灵活、最终定位后牢固,保证电极的贴合度,进而保证消融效果。Optionally, the magnetic force of the magnetic piece is controllable and adjustable, a small magnetic force is used in the initial positioning, and a large magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible in the initial positioning and firm in the final positioning, so as to ensure the electrode assembly. The degree of fit, thereby ensuring the ablation effect.
可选地,多个第一磁性件112均设置在保护鞘113的管腔内。Optionally, the plurality of first magnetic members 112 are all disposed in the lumen of the protective sheath 113 .
可选地,第一磁性件112为电磁铁;和/或,第二磁性件212为电磁铁。Optionally, the first magnetic member 112 is an electromagnet; and/or the second magnetic member 212 is an electromagnet.
可选地,多个第一磁性件112均设置在第一保护鞘113内,多个第一磁性件112沿第一保护鞘113的延伸方向间隔设置。可选地,多个第一磁性件112与多个第一电极111沿保护鞘113的延伸方向交错布置,以使多个第一电极111间隔布置,即使用各个第一磁性件112隔开相应的两个第一电极111。在工作时,每对第一磁性件112和第二磁性件212相对独立工作,即可以根据实际需求决定磁性件工作的数量。磁性件的磁力是可控并且可调整的,初定位时使用较小磁力,最终定位时使用较大磁力,使得内外两个电极组件初定位时灵活、最终定位后牢固,保证电极的贴合度,进而保证消融效果。Optionally, the plurality of first magnetic members 112 are all disposed in the first protective sheath 113 , and the plurality of first magnetic members 112 are disposed at intervals along the extending direction of the first protective sheath 113 . Optionally, the plurality of first magnetic members 112 and the plurality of first electrodes 111 are alternately arranged along the extending direction of the protective sheath 113 , so that the plurality of first electrodes 111 are arranged at intervals, that is, each first magnetic member 112 is used to separate the corresponding of the two first electrodes 111 . During operation, each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs. The magnetic force of the magnetic parts is controllable and adjustable. A small magnetic force is used in the initial positioning, and a larger magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible at the initial positioning and firm after the final positioning, so as to ensure the fit of the electrodes. , thereby ensuring the ablation effect.
在本实施例中,保护鞘113的相对两侧均设置有遮挡侧檐115,以对保护鞘113内部的多个第一电极111和多个第一磁性件112均形成遮挡防护作用,以避免消融过程中心膜组织的血液等进入第一保护鞘113与心脏外膜之间的区域内而影响保护鞘113与心脏外膜之间的贴紧程度,避免消融时第一电极111和第二电极211间电阻值的测量精度,从而影响消融效果。另外,通过设置遮挡侧檐115,可遮挡消融线外的组织液及生理盐水等液体进入消融部位,避免消融时第一电极111和第二电极211间电阻值的测量精度,从而影响消融效果。In the present embodiment, shielding side eaves 115 are provided on opposite sides of the protective sheath 113 to form shielding protection for the plurality of first electrodes 111 and the plurality of first magnetic members 112 inside the protective sheath 113 to avoid During the ablation process, blood in the epicardial tissue enters the area between the first protective sheath 113 and the epicardium, which affects the tightness between the protective sheath 113 and the epicardium, avoiding the first electrode 111 and the second electrode during ablation. The measurement accuracy of the resistance value between 211 affects the ablation effect. In addition, by setting the shielding side eave 115, the tissue fluid outside the ablation line and liquids such as physiological saline can be shielded from entering the ablation site, so as to avoid the measurement accuracy of the resistance value between the first electrode 111 and the second electrode 211 during ablation, thereby affecting the ablation effect.
在本实施例中,遮挡侧檐115的一种设置方式为:如图3所示,遮挡侧檐115为条形,遮挡侧檐115沿保护鞘113的延伸方向延伸。In this embodiment, an arrangement of the shielding side eave 115 is as follows: as shown in FIG.
在本实施例中,遮挡侧檐115的另一种设置方式为:如图4所示,遮挡侧檐115为多个,多个遮挡侧檐115沿第一保护鞘113的延伸方向布置并依次拼接。In this embodiment, another arrangement of the shielding side eaves 115 is as follows: as shown in FIG. 4 , there are multiple shielding side eaves 115 , and the plurality of shielding side eaves 115 are arranged along the extending direction of the first protective sheath 113 and in sequence stitching.
可选地,如图5所示,电极111和/或第一磁性件112上设置有用于容纳导线118的导线铺设槽120,导线118用于与电极111连接;或者,将用于铺设导线118的导线铺设槽120设置在第一保护鞘113的内壁上。Optionally, as shown in FIG. 5 , the electrode 111 and/or the first magnetic member 112 is provided with a wire laying groove 120 for accommodating the wire 118, and the wire 118 is used to connect with the electrode 111; or, the wire 118 will be used for laying the wire The wire laying groove 120 is arranged on the inner wall of the first protective sheath 113 .
在本实施例中,如图8和图9所示,第二电极端头210包括第二保护鞘214,第二电极211设置在第二保护鞘214上;其中,第二电极端头210包括显影件213,显影件213设置在第二保护鞘214上,以通过显影件213标记第二电极端头210的位置; 和/或,第二电极211由金属显影材料制成,金属显影材料包括以下材料中的至少一种:铂金、铂依合金、钽、镀金铍青铜;和/或,第二保护鞘214由显影材料制成,显影材料的制作材料包括硫酸钡(BaSO4)。In this embodiment, as shown in FIGS. 8 and 9 , the second electrode tip 210 includes a second protective sheath 214 , and the second electrode 211 is disposed on the second protective sheath 214 ; wherein the second electrode tip 210 includes The developing member 213, the developing member 213 is disposed on the second protective sheath 214, so as to mark the position of the second electrode end 210 by the developing member 213; and/or, the second electrode 211 is made of a metal developing material, and the metal developing material includes At least one of the following materials: platinum, platinum-based alloy, tantalum, gold-plated beryllium bronze; and/or, the second protective sheath 214 is made of a developing material, and the developing material is made of barium sulfate (BaSO4).
第一电极组件100包括多个第一电极端头110,第二电极组件200包括多个第二电极端头210。The first electrode assembly 100 includes a plurality of first electrode tips 110 , and the second electrode assembly 200 includes a plurality of second electrode tips 210 .
参照图12至15所示,可以看出本实施例中的消融装置对待消融组织340的消融原理,并可以体现消融装置的消融范围330。Referring to FIGS. 12 to 15 , it can be seen that the ablation device in this embodiment ablation principle of the tissue to be ablated 340 , and can reflect the ablation range 330 of the ablation device.
可选地,多个第二磁性件212与多个第二电极211均套设在第二保护鞘214上;可选地,多个第二磁性件212与多个第二电极211沿第二保护鞘的延伸方向交错布置,以使多个第二电极211间隔布置,即使用各个第二磁性件212隔开相应的两个第二电极211。Optionally, the plurality of second magnetic members 212 and the plurality of second electrodes 211 are sleeved on the second protective sheath 214; The extension directions of the protective sheaths are staggered, so that the plurality of second electrodes 211 are arranged at intervals, that is, each second magnetic member 212 is used to separate the corresponding two second electrodes 211 .
可选地,参照图13和图19,多个第二磁性件212与多个第二电极211均为环状结构,或为多边形、V型、D型、拱形等截面结构。如图19所示,第二电极211的截面为多边形,例如可为方形。本实施例中的显影件213、具有显影作用的第二电极211以及具有显影作用的第二保护鞘214可以在第二电极组件200进入消融部位时的位置指示。可选地,第二电极端头210上的显影件213的数量为3-6个,且可以单独设置也可以是第二电极211带有显影功能。本实施例中的显影件213和第二保护鞘214的鞘体外壁是平齐的,防止手术中对病人造成损伤。Optionally, referring to FIG. 13 and FIG. 19 , the plurality of second magnetic members 212 and the plurality of second electrodes 211 are all annular structures, or have cross-sectional structures such as polygonal, V-shaped, D-shaped, and arched. As shown in FIG. 19 , the cross section of the second electrode 211 is a polygon, for example, a square. In this embodiment, the developing member 213 , the second electrode 211 with a developing function, and the second protective sheath 214 with a developing function can indicate the position of the second electrode assembly 200 when it enters the ablation site. Optionally, the number of the developing members 213 on the second electrode end 210 is 3-6, and the number of the developing members 213 may be set independently or the second electrode 211 may have a developing function. In this embodiment, the outer walls of the developing member 213 and the second protective sheath 214 are flush to prevent damage to the patient during the operation.
在本实施例中,显影件213可以没有,显影件213也可以为多个,多个显影件213沿第二保护鞘214的延伸方向间隔设置;和/或,第二保护鞘214的外表面分为与显影件213对应的部分形成第一表面部和与第一表面部连接的第二表面部,第一表面部为凹陷结构,显影件213套设在第一表面部上,显影件213的外表面与第二表面部平齐或低于第二表面部。In this embodiment, the developing member 213 may be absent, or there may be multiple developing members 213, and the multiple developing members 213 are arranged at intervals along the extending direction of the second protective sheath 214; and/or, the outer surface of the second protective sheath 214 The first surface portion and the second surface portion connected to the first surface portion are formed by dividing into a portion corresponding to the developing member 213. The first surface portion is a concave structure, and the developing member 213 is sleeved on the first surface portion. The developing member 213 The outer surface is flush with the second surface portion or lower than the second surface portion.
在工作时,首先将第一电极组件100通过定位件固定在心外膜上,接着第二电极组件200进入心脏内部,通过显影件213的指示将第二电极组件200放置到心内膜中第一电极组件100对应的部位,然后同步、顺序开启位于第一电极端头110和第二电极端头210的第一对磁性件、第二对磁性件及第三对磁性件,此时两组电极完成初定位。完成初定位后的两个电极组件接着将其余的磁性件成对开启,完成最终的定位。During operation, the first electrode assembly 100 is first fixed on the epicardium through the positioning member, then the second electrode assembly 200 enters the heart, and the second electrode assembly 200 is placed in the endocardium through the indication of the developing member 213. At the corresponding part of the electrode assembly 100, the first pair of magnetic parts, the second pair of magnetic parts and the third pair of magnetic parts located at the first electrode end 110 and the second electrode end 210 are turned on synchronously and sequentially. At this time, two sets of electrodes Complete initial positioning. After completing the initial positioning, the two electrode assemblies then turn on the remaining magnetic parts in pairs to complete the final positioning.
可选地,第一电极111和第二电极211工作时是每对电极相对独立的,即可以控制工作电极的数量。Optionally, when the first electrode 111 and the second electrode 211 work, each pair of electrodes is relatively independent, that is, the number of working electrodes can be controlled.
在本实施例中,如图6所示,第一电极111具有朝向待消融组织设置的电极面1110,保护鞘113具有朝向待消融组织设置的保护鞘面1130;其中,电极面1110位于保护鞘面1130靠近待消融组织的一侧。In this embodiment, as shown in FIG. 6 , the first electrode 111 has an electrode surface 1110 facing the tissue to be ablated, and the protective sheath 113 has a protective sheath surface 1130 facing the tissue to be ablated; wherein, the electrode surface 1110 is located on the protective sheath Face 1130 is near the side of the tissue to be ablated.
在本实施例中,第一电极111为多个,多个第一电极111沿第一电极端头110的延伸方向间隔布置;多个第一电极111的电极面1110与保护鞘面1130之间的最小距离均相同。第一电极111的电极面1110与保护鞘面1130之间的最小距离的取值范围0-0.5mm,存在此高度差可以使得第一电极111与被消融表面充分接触,保证消融效果。第一电极111的电极面1110与保护鞘面1130之间的高度差取值优先为0.2mm。In this embodiment, there are multiple first electrodes 111, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; between the electrode surfaces 1110 of the multiple first electrodes 111 and the protective sheath surface 1130 The minimum distances are the same. The value range of the minimum distance between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is 0-0.5 mm. The existence of this height difference can make the first electrode 111 fully contact the surface to be ablated to ensure the ablation effect. The height difference between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is preferably 0.2 mm.
在本实施例中,电极面1110和保护鞘面1130均为平面。In this embodiment, the electrode surface 1110 and the protective sheath surface 1130 are both flat surfaces.
为了实现对第一电极端头110的冷却,如图6所示,第一电极111为多个,多个第一电极111沿第一电极端头110的延伸方向间隔布置;多个第一电极111中的至少一个第一电极111上设置有用于供冷却流体流通的冷却孔1112;和/或,第一保护鞘113内设置有供冷却流体流通的冷却管道。本实施例通过设置冷却孔1112,用于消融过程中局部的降温,用来保护消融部位之外的其他部位不被损伤。通过设置冷却通道,可以在电极侧边进行冷却。In order to achieve cooling of the first electrode tip 110, as shown in FIG. 6, there are multiple first electrodes 111, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; At least one of the first electrodes 111 in the 111 is provided with a cooling hole 1112 for circulating a cooling fluid; and/or a cooling pipe for circulating a cooling fluid is provided in the first protective sheath 113 . In this embodiment, the cooling holes 1112 are provided for local cooling during the ablation process, so as to protect other parts other than the ablation site from being damaged. By providing cooling channels, cooling can be performed on the sides of the electrodes.
在本实施例中,多个第一电极111中的至少一个第一电极111上设置有1至4个冷却孔1112。每个第一电极111上的冷却孔数量为0-4个,以保证消融过程中温度的控制。In this embodiment, at least one of the plurality of first electrodes 111 is provided with 1 to 4 cooling holes 1112 . The number of cooling holes on each first electrode 111 is 0-4 to ensure temperature control during ablation.
本公开还提供了一种射频消融设备,如图11所示,该射频消融设备包括射频主机310和上述的消融装置,该消融装置与射频主机310连接。The present disclosure also provides a radio frequency ablation device. As shown in FIG. 11 , 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 .
可选地,如图10所示,射频主机310上设置有显示屏313,显示屏313用于显示所测出的两个相对应的第一电极111和第二电极211之间被消融组织的阻抗和/或射频功率。Optionally, as shown in FIG. 10 , the radio frequency host 310 is provided with a display screen 313 , and the display screen 313 is used to display the measured values of the tissue to be ablated between the two corresponding first electrodes 111 and the second electrodes 211 . Impedance and/or RF power.
可选地,射频主机310上还设置有消融接口311,第一电极组件100和第二电极组件200均包括多个导线组件,各个导线组件包括导线接头和与导线接头连接的多个并联设置的导线,各个导线用于与相应的电极连接;消融接口311具有第一消融接口部和第二消融接口部,第一消融接口部具有用于供第一电极组件100的多个导线接头插入的多个第一消融接口,第二消融接口部具有用于供第二电极组件200的多个导线接头插入的多个第二消融接口,以通过各个第一消融接口和各个第二消融接口向相应的第一电极和相应的第二电极211提供合适的射频功率。Optionally, the radio frequency host 310 is further provided with an ablation interface 311, the first electrode assembly 100 and the second electrode assembly 200 each include a plurality of lead assemblies, and each lead assembly includes a lead connector and a plurality of parallel connection connected to the lead connector. Lead wires, each lead wire is used to connect with the corresponding electrode; the ablation interface 311 has a first ablation interface part and a second ablation interface part, and the first ablation interface part has a plurality of lead wires for inserting the plurality of lead wires of the first electrode assembly 100. a first ablation interface, the second ablation interface part has a plurality of second ablation interfaces for inserting a plurality of lead wires of the second electrode assembly 200, so as to communicate with the corresponding The first electrode and corresponding second electrode 211 provide suitable radio frequency power.
可选地,当第一磁性件112和第二磁性件212均为电磁铁时,射频主机310上还设置有电磁接口312,第一电极组件100和第二电极组件200均包括多个电磁铁组件,各个电磁铁组件包括电磁接头和与电磁接头连接的多个并联设置的电磁线,各个电磁线用于与相应的电磁铁连接;电磁接口312具有第一电磁接口部和第二电磁接口部,第一电磁接口部具有用于供第一电极组件100的多个电磁接头插入的多个第一磁接口,第二电磁接口部具有用于供第二电极组件200的多个电磁接头插入的多个第二磁接口,以通过各个第一磁接口和各个第二磁接口向相应的第一磁性件112和相应的第二磁性件212供电,进而使相应的第一磁性件112和相应的第二磁性件212之间产生吸合力。Optionally, when the first magnetic member 112 and the second magnetic member 212 are both electromagnets, the radio frequency host 310 is further provided with an electromagnetic interface 312, and both the first electrode assembly 100 and the second electrode assembly 200 include a plurality of electromagnets. components, each electromagnet assembly includes an electromagnetic joint and a plurality of electromagnetic wires connected in parallel with the electromagnetic joint, and each electromagnetic wire is used to connect with 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 a plurality of first magnetic interfaces for inserting a plurality of electromagnetic joints of the first electrode assembly 100 , and the second electromagnetic interface part has a plurality of electromagnetic joints for inserting a plurality of electromagnetic joints of the second electrode assembly 200 a plurality of second magnetic interfaces, so as to supply power to the corresponding first magnetic member 112 and the corresponding second magnetic member 212 through each of the first magnetic An attraction force is generated between the second magnetic members 212 .
从以上的描述中,可以看出,本公开上述的实施例实现了如下技术效果:From the above description, it can be seen that the above-mentioned embodiments of the present disclosure achieve the following technical effects:
在本公开的电极组件中,该电极组件包括电极端头110,电极端头110包括第一保护鞘113以及设置在第一保护鞘113内的第一电极111和填充件116,通过填充件116对第一电极111进行挤压以使第一电极111朝向待消融组织移动,进而使第一电极111能够与第一保护鞘113的内壁贴合,而相对应的位置的第一保护鞘113的外壁与相应的待消融组织贴合,从而保证第一电极111能够较好地作用于相应的待消融组织,保证消融效果;可见,使用本电极组件能够解决现有技术中的内科介入式消融装置消融效果不理想的问题。In the electrode assembly of the present disclosure, the electrode assembly includes an electrode tip 110 , the electrode tip 110 includes a first protective sheath 113 , and a first electrode 111 and a filling member 116 disposed in the first protective sheath 113 , through the filling member 116 The first electrode 111 is squeezed to move the first electrode 111 toward the tissue to be ablated, so that the first electrode 111 can fit with the inner wall of the first protective sheath 113, and the corresponding position of the first protective sheath 113 The outer wall is attached to the corresponding tissue to be ablated, so as to ensure that the first electrode 111 can better act on the corresponding tissue to be ablated and ensure the ablation effect; it can be seen that the use of this electrode assembly can solve the medical interventional ablation device in the prior art The problem of unsatisfactory ablation effect.
应用本公开的技术方案,该消融装置包括具有第一电极端头的第一电极组件和具有第二电极端头的第二电极组件。第一电极组件和第二电极组件可独立使用,第一电极端头包括第一保护鞘和设置于第一保护鞘的多个第一电极;并且,第一保护鞘为条形,多个第一电极沿第一保护鞘的延伸方向间隔布置,即通过多个第一电极同时作用于心外膜组织,以形成一条完整的消融线,当保护鞘使用柔性材质时,可以解决现有外科器械使用时角度受限,手术操作不方便的问题。Applying the technical solutions of the present disclosure, the ablation device includes a first electrode assembly having a first electrode tip and a second electrode assembly having a second electrode tip. The first electrode assembly and the second electrode assembly can be used independently, and the first electrode tip includes a first protective sheath and a plurality of first electrodes disposed on the first protective sheath; An electrode is arranged at intervals along the extension direction of the first protective sheath, that is, a plurality of first electrodes act on the epicardial tissue at the same time to form a complete ablation line. When the protective sheath is made of flexible material, it can solve the problem of existing surgical instruments. The angle of use is limited and the surgical operation is inconvenient.
该消融装置第一电极和第二电极相对设置,以通过第一电极和第二电极对位于第一电极和第二电极之间的待消融组织进行消融。使用时,将第一电极组件和第二电极组件分别用作心外膜电极和心内膜电极,以使第一电极组件和第二电极组件分别作用于心外膜和心内膜,以实现同时消融心外膜和心内膜,从而实现良好的消融效果,解决内科介入消融能量恒定,无法适时根据消融效果调整输出功率,导致过烧或不透壁问题和心外科是动态消融,但外科消融创伤较大,术后恢复慢的问题;从而实现良好的消融效果,并提高消融效率;可见,使用本消融装置能够解决现有技术中的消融装 置的消融效果不理想的问题。The first electrode and the second electrode of the ablation device are arranged opposite to each other, so that the tissue to be ablated located between the first electrode and the second electrode is ablated by the first electrode and the second electrode. When in 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, to achieve Simultaneously ablate the epicardium and endocardium to achieve a good ablation effect, solve the problem that the energy of medical interventional ablation is constant, and the output power cannot be adjusted according to the ablation effect in a timely manner, resulting in overburning or wall impermeability and cardiac surgery is dynamic ablation, but surgery The ablation trauma is relatively large and the postoperative recovery is slow; thereby achieving a good ablation effect and improving ablation efficiency; it can be seen that the use of the ablation device can solve the problem of unsatisfactory ablation effect of the ablation device in the prior art.
本公开的消融装置包括上述的电极组件,因此该消融装置至少具有与该电极组件相同的技术效果。The ablation device of the present disclosure includes the above-mentioned electrode assembly, so the ablation device has at least the same technical effect as the electrode assembly.
本公开的射频消融设备包括上述的消融装置,因此该射频消融设备至少具有与该消融装置相同的技术效果。The radio frequency ablation device of the present disclosure includes the above-mentioned ablation device, so the radio frequency ablation device has at least the same technical effect as the ablation device.
本公开提供了一种消融装置,请参考图1至图19,该消融装置包括第一电极组件100和第二电极组件200,第一电极组件100包括第一电极端头110,第一电极端头110包括第一保护鞘113、第一电极111以及填充件116,第一电极111设置在第一保护鞘113内;填充件116设置在第一保护鞘113内,以通过填充件116将第一保护鞘113内的第一电极111朝向待消融部位挤压;其中,第二电极组件200包括第二电极端头210,第二电极端头210包括第二电极211,第二电极211与第一电极111相对设置,以通过第一电极111和第二电极211对位于第一电极111和第二电极211之间的待消融部位进行消融。The present disclosure provides an ablation device, please refer to FIG. 1 to FIG. 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 tip 110 , the first electrode end The head 110 includes a first protective sheath 113 , a first electrode 111 and a filling member 116 . The first electrode 111 is arranged in the first protective sheath 113 ; The first electrode 111 in a protective sheath 113 is pressed toward the site to be ablated; wherein, the second electrode assembly 200 includes a second electrode tip 210, the second electrode tip 210 includes a second electrode 211, and the second electrode 211 and the first electrode An electrode 111 is disposed opposite to each other to ablate the site to be ablated between the first electrode 111 and the second electrode 211 through the first electrode 111 and the second electrode 211 .
在本公开的消融装置中,该消融装置包括第一电极组件100和第二电极组件200,第一电极组件100包括第一电极端头110,第一电极端头110包括第一保护鞘113以及设置在第一保护鞘113内的第一电极111和填充件116,通过填充件116对第一电极111进行挤压以使第一电极111朝向待消融部位移动,进而使第一电极111能够与第一保护鞘113的内壁贴合,而相对应的位置的第一保护鞘113的外壁与相应的待消融部位贴合,从而保证第一电极111能够较好地作用于相应的待消融部位,保证消融效果;第二电极组件200包括第二电极端头210,第二电极端头210包括与第一电极111相对设置的第二电极211,以通过第一电极111和第二电极211对位于第一电极111和第二电极211之间的待消融部位进行消融。使用时,将第一电极组件100和第二电极组件200分别用作心外膜电极和心内膜电极,以使第一电极组件100和第二电极组件200分别作用于心外膜和心内膜,以实现同时消融心外膜和心内膜,从而实现良好的消融效果。可见,使用本消融装置能够解决现有技术中的消融装置的消融效果不理想的问题。In the ablation device of the present disclosure, 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, and the first electrode tip 110 includes a first protective sheath 113 and The first electrode 111 and the filler 116 are arranged in the first protective sheath 113, and the first electrode 111 is squeezed by the filler 116 to move the first electrode 111 toward the site to be ablated, so that the first electrode 111 can interact with the site to be ablated. The inner wall of the first protective sheath 113 is fitted, and the outer wall of the first protective sheath 113 at the corresponding position is fitted with the corresponding part to be ablated, so as to ensure that the first electrode 111 can better act on the corresponding part to be ablated, To ensure the ablation effect; the second electrode assembly 200 includes a second electrode tip 210, and the second electrode tip 210 includes a second electrode 211 arranged opposite to the first electrode 111, so as to be located in the opposite direction by the first electrode 111 and the second electrode 211. The site to be ablated between the first electrode 111 and the second electrode 211 is ablated. In 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 heart, respectively membrane to achieve simultaneous epicardium and endocardium ablation for good ablation results. It can be seen that the use of the ablation device can solve the problem that the ablation effect of the ablation device in the prior art is not ideal.
另外,本公开中的消融装置可以实现内、外科杂交式消融,此技术创伤小,解决了现有技术中外科消融创伤大、恢复慢的难题,同时又可以从心外膜和心内膜联合同步消融,通过测试组织间的实际阻抗调整输出功率,精确、安全,且阻抗达到一定阻值后机器报警消融完毕,避免过度消融。In addition, the ablation device in the present disclosure can realize hybrid ablation of internal and surgical techniques. This technique has little trauma, which solves the problems of large trauma and slow recovery in the prior art for surgical ablation. Simultaneous ablation adjusts the output power by testing the actual impedance between tissues, which is accurate and safe, and the machine alarms when the impedance reaches a certain resistance value to complete the ablation to avoid excessive ablation.
可选地,消融装置还包括消融电路320,第一电极111和第二电极211均设置在消融电路320上,以通过测试第一电极111和相应的第二电极211之间的阻抗调整第一电极111和第二电极211之间的射频能量来进行消融。通过使第一电极111和第二电极211相对设置,可以实时测试第一电极111和第二电极211之间的阻抗,并根据实时检测的第一电极111和第二电极211之间的阻抗来调整第一电极111和第二电极211之间的射频功率,且阻抗达到一定阻值后机器报警消融完毕,避免过度消融,以解决现有技术中介入式消融单侧消融深度有限、难以保证组织由内至外完全脱水、变性的问题,同时解决了射频功率不易控制的问题,功率较小会造成消融不彻底,功率过大会造成消融过度,组织坏死甚至烧穿、烧漏现象。Optionally, 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 adjust the first electrode 111 and the corresponding second electrode 211 by testing the impedance between the first electrode 111 and the corresponding second electrode 211 . The ablation is performed by radio frequency energy between the electrode 111 and the second electrode 211 . By arranging the first electrode 111 and the second electrode 211 opposite to each other, the impedance between the first electrode 111 and the second electrode 211 can be tested in real time, and the impedance between the first electrode 111 and the second electrode 211 detected in real time can be measured in real time. Adjust the radio frequency power between the first electrode 111 and the second electrode 211, and after the impedance reaches a certain resistance value, the machine alarms that the ablation is completed to avoid excessive ablation, so as to solve the problem that the unilateral ablation depth of the interventional ablation in the prior art is limited and it is difficult to guarantee the tissue It solves the problem of complete dehydration and degeneration from the inside to the outside, and solves the problem that the radio frequency power is not easy to control. Low power will cause incomplete ablation, and excessive power will cause excessive ablation, tissue necrosis and even burn through and leakage.
在消融过程中,电极间被消融组织的阻抗由低到高进行变化;在进行消融的第一阶段,电极间被消融组织的阻抗逐渐增大,射频功率保持不变,以加快细胞内分子的震动;在进行消融的第二阶段,随着电极间被消融组织的阻抗的增大,射频功率逐步增大,当电极间被消融组织的阻抗增大到其第一预设值时,射频功率也增大到其预设最大值,在此消融阶段,使得细胞迅速脱水以产生不可逆的变化;在进行消融的第三阶段,随着电极间被消融组织的阻抗的继续增大,射频功率逐步降低,以保证消融彻底性的同时预防因射频大功率输出而造成组织表面结痂或者损伤患者的现象;直至电极间被消融组织的阻抗增大到其第二预设值时,提示结束消融。During the ablation process, the impedance of the tissue to be ablated between the electrodes changes from low to high; in the first stage of ablation, the impedance of the tissue to be ablated between the electrodes gradually increases, and the RF power remains unchanged to accelerate the intracellular molecules. Vibration; in the second stage of ablation, as the impedance of the ablated tissue between the electrodes increases, the radio frequency power gradually increases, and when the impedance of the ablated tissue between the electrodes increases to its first preset value, the radio frequency power It 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 RF power gradually increases. It is decreased to ensure the completeness of ablation and prevent the phenomenon of scarring on the tissue surface or damage to the patient caused by the high power output of the radio frequency; until the impedance of the ablated tissue between the electrodes increases to its second preset value, the end of the ablation is prompted.
可选地,如图3和图8所示,第一电极111和第二电极211均为多个,多个第一电极111和多个第二电极211相互配合设置;通过设置多个第一电极111和多个第二电极211,以使得多个第一电极111和多个第二电极211能够同时作用于其相对应的待消融部位,以保证消融效果、提高消融效率;且使多个第一电极111间隔布置,可以避免相邻两个第一电极111之间相互影响。多个第二电极211间隔布置,以避免相邻两个第二电极211之间相互影响。Optionally, as shown in FIG. 3 and FIG. 8 , there are multiple first electrodes 111 and multiple second electrodes 211, and multiple first electrodes 111 and multiple second electrodes 211 are arranged in cooperation with each other; by setting multiple first electrodes 111 and multiple second electrodes 211 Electrodes 111 and multiple second electrodes 211, so that multiple first electrodes 111 and multiple second electrodes 211 can simultaneously act on their corresponding parts to be ablated, so as to ensure ablation effect and improve ablation efficiency; The first electrodes 111 are arranged at intervals to avoid mutual influence between two adjacent first electrodes 111 . The plurality of second electrodes 211 are arranged at intervals to avoid mutual influence between two adjacent second electrodes 211 .
可选地,第一保护鞘113为条形,多个第一电极111沿第一保护鞘113的延伸方向间隔布置;即通过多个第一电极111同时作用于其相对应的待消融部位,以形成一条完整的消融线。Optionally, the first protective sheath 113 is strip-shaped, and the plurality of first electrodes 111 are arranged at intervals along the extending direction of the first protective sheath 113; to form a complete ablation line.
可选地,第一保护鞘113为管状,多个第一电极111均设置在第一保护鞘113的管腔内。Optionally, the first protective sheath 113 is tubular, and the plurality of first electrodes 111 are disposed in the lumen of the first protective sheath 113 .
在本实施例中,第一电极111为2至10个。可选地,填充件116为柔性块。In this embodiment, the number of the first electrodes 111 is 2 to 10. Optionally, filler 116 is a flexible mass.
在本实施例中,填充件116的一种设置方式为:如图2所示,填充件116为条形, 填充件116沿第一保护鞘113的延伸方向延伸。可选地,填充件116为气囊结构,以在该气囊结构被充气而膨胀时,对多个第一电极111形成挤压作用。In this embodiment, an arrangement of the filler 116 is as follows: as shown in FIG. 2 , the filler 116 is strip-shaped, and the filler 116 extends along the extending direction of the first protective sheath 113 . Optionally, the filler 116 is an airbag structure, so as to form a pressing effect on the plurality of first electrodes 111 when the airbag structure is inflated and expanded.
在本实施例中,填充件116的另一种设置方式为:填充件116为多个,多个填充件116沿第一保护鞘113的延伸方向间隔布置;多个填充件116和多个第一电极111一一对应地设置,以使各个填充件116能够对相应的第一电极111形成挤压作用;各个填充件116均设置在相应的第一电极111的远离待消融部位的一侧,以实现各个填充件116对相应的第一电极111形成挤压作用时,各个第一电极111朝靠近相应的待消融部位的方向移动。可选地,各个填充件116均为气囊结构,以在该气囊结构被充气而膨胀时,对相应的第一电极111形成挤压作用。In this embodiment, another arrangement of the fillers 116 is as follows: there are multiple fillers 116 , and the multiple fillers 116 are arranged at intervals along the extending direction of the first protective sheath 113 ; the multiple fillers 116 and the multiple The electrodes 111 are arranged in a one-to-one correspondence, so that each filler 116 can form a pressing effect on the corresponding first electrode 111; In order to realize that each filler 116 forms a pressing effect on the corresponding first electrode 111, each first electrode 111 moves in a direction close to the corresponding part to be ablated. Optionally, each filling member 116 is an airbag structure, so that when the airbag structure is inflated and inflated, a pressing effect is formed on the corresponding first electrode 111 .
可选地,第一保护鞘113上设置有用于避让第一电极111的开孔结构,以使第一电极111的部分结构经开孔结构由第一保护鞘113的腔体伸出,这样,伸出第一保护鞘113的腔体的这部分电极结构能够与相应的待消融部位直接接触,进而使这部分电极结构更好地作用于其相应的待消融部位,以进一步保证消融效果、提高消融效率。Optionally, the first protective sheath 113 is provided with an opening structure for avoiding the first electrode 111, so that part of the structure of the first electrode 111 is protruded from the cavity of the first protective sheath 113 through the opening structure, so that, This part of the electrode structure extending out of the cavity of the first protective sheath 113 can be in direct contact with the corresponding part to be ablated, so that this part of the electrode structure can better act on its corresponding part to be ablated, so as to further ensure the ablation effect and improve the Ablation efficiency.
在本实施例中,开孔结构的一种设置形式为:当第一电极111为多个,开孔结构包括多个避让开孔,多个避让开孔与多个第一电极111一一对应地设置,以使各个第一电极111的部分结构通过相应的避让开孔伸出至第一保护鞘113的外侧,进而使伸出第一保护鞘113外侧的各个第一电极111的部分结构均能够与相应的待消融部位直接接触。In this embodiment, a setting form of the opening structure is: when there are multiple first electrodes 111 , the opening structure includes multiple avoidance openings, and the multiple avoidance openings correspond to the multiple first electrodes 111 one-to-one so that the part of the structure of each first electrode 111 protrudes to the outside of the first protective sheath 113 through the corresponding avoidance holes, so that the part of the structure of each first electrode 111 protruding from the outside of the first protective sheath 113 is Can be in direct contact with the corresponding site to be ablated.
在本实施例中,开孔结构的另一种设置形式为:开孔结构为条形开口,条形开口沿第一保护鞘113的延伸方向间隔,多个第一电极111的部分结构通过条形开口伸出至第一保护鞘113的外侧。In this embodiment, another setting form of the opening structure is as follows: the opening structure is a strip-shaped opening, the strip-shaped openings are spaced along the extending direction of the first protective sheath 113 , and the partial structures of the plurality of first electrodes 111 pass through the strips. The shaped opening protrudes to the outside of the first protective sheath 113 .
可选地,第二电极端头210包括第二保护鞘,多个第二电极211套设在第二保护鞘上;其中,多个第一电极111和多个第二电极211相互配合设置。Optionally, the second electrode tip 210 includes a second protective sheath, and a plurality of second electrodes 211 are sleeved on the second protective sheath; wherein, the plurality of first electrodes 111 and the plurality of second electrodes 211 are arranged in cooperation with each other.
可选地,第二保护鞘为条形,多个第二电极211沿第二保护鞘的延伸方向间隔布置;即通过多个第二电极211同时作用于其相对应的待消融部位,以形成一条完整的消融线。Optionally, the second protective sheath is strip-shaped, and the plurality of second electrodes 211 are arranged at intervals along the extending direction of the second protective sheath; that is, the plurality of second electrodes 211 simultaneously act on the corresponding parts to be ablated to form A complete ablation line.
在本实施例中,第一电极端头110还包括第一磁性件112,第二电极端头210包括第二磁性件212,第一磁性件112和第二磁性件212相配合,以使第一电极端头110和第二电极端头210相对固定,进而使得第一电极端头110的第一电极111能够与第二电极端头210的相应的第二电极211相对设置。In this embodiment, the first electrode tip 110 further includes a first magnetic member 112 , the second electrode tip 210 includes a second magnetic member 212 , and the first magnetic member 112 and the second magnetic member 212 cooperate with each other, so that the An electrode tip 110 and a second electrode tip 210 are relatively fixed, so that the first electrode 111 of the first electrode tip 110 can be disposed opposite to the corresponding second electrode 211 of the second electrode tip 210 .
可选地,第一磁性件112和第二磁性件212均为多个,多个第一磁性件112沿第一电极端头110的延伸方向间隔布置,多个第二磁性件212沿第二电极端头210的延伸方向间隔布置,以保证第一电极端头110和第二电极端头210之间的整体固定效果。Optionally, there are multiple first magnetic members 112 and second magnetic members 212 , the multiple first magnetic members 112 are arranged at intervals along the extending direction of the first electrode tip 110 , and the multiple second magnetic members 212 are arranged along the extending direction of the first electrode tip 110 . The extending directions of the electrode terminals 210 are arranged at intervals to ensure the overall fixing effect between the first electrode terminal 110 and the second electrode terminal 210 .
可选地,每对第一磁性件112和第二磁性件212相对独立工作,即可以根据实际需求决定磁性件工作的数量。Optionally, each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs.
可选地,磁性件的磁力是可控并且可调整的,初定位时使用较小磁力,最终定位时使用较大磁力,使得内外两个电极组件初定位时灵活、最终定位后牢固,保证电极的贴合度,进而保证消融效果。Optionally, the magnetic force of the magnetic piece is controllable and adjustable, a small magnetic force is used in the initial positioning, and a large magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible in the initial positioning and firm in the final positioning, so as to ensure the electrode assembly. The degree of fit, thereby ensuring the ablation effect.
可选地,多个第一磁性件112均设置在第一保护鞘113的管腔内。Optionally, the plurality of first magnetic members 112 are all disposed in the lumen of the first protective sheath 113 .
可选地,第一磁性件112为电磁铁;和/或,第二磁性件212为电磁铁。Optionally, the first magnetic member 112 is an electromagnet; and/or the second magnetic member 212 is an electromagnet.
可选地,多个第一磁性件112均设置在第一保护鞘113内,多个第一磁性件112沿第一保护鞘113的延伸方向间隔设置。可选地,多个第一磁性件112与多个第一电极111沿第一保护鞘113的延伸方向交错布置,以使多个第一电极111间隔布置,即使用各个第一磁性件112隔开相应的两个第一电极111。在工作时,每对第一磁性件112和第二磁性件212相对独立工作,即可以根据实际需求决定磁性件工作的数量。磁性件的磁力是可控并且可调整的,初定位时使用较小磁力,最终定位时使用较大磁力,使得内外两个电极组件初定位时灵活、最终定位后牢固,保证电极的贴合度,进而保证消融效果。Optionally, the plurality of first magnetic members 112 are all disposed in the first protective sheath 113 , and the plurality of first magnetic members 112 are disposed at intervals along the extending direction of the first protective sheath 113 . Optionally, the plurality of first magnetic members 112 and the plurality of first electrodes 111 are alternately arranged along the extending direction of the first protective sheath 113 , so that the plurality of first electrodes 111 are arranged at intervals, that is, each first magnetic member 112 is used to separate the plurality of first electrodes 111 . The corresponding two first electrodes 111 are turned on. During operation, each pair of the first magnetic member 112 and the second magnetic member 212 works relatively independently, that is, the number of the magnetic members to work can be determined according to actual needs. The magnetic force of the magnetic parts is controllable and adjustable. A small magnetic force is used in the initial positioning, and a larger magnetic force is used in the final positioning, so that the inner and outer two electrode assemblies are flexible at the initial positioning and firm after the final positioning, so as to ensure the fit of the electrodes. , thereby ensuring the ablation effect.
可选地,多个第二磁性件212均套设在第二保护鞘上,多个第二磁性件212沿第二保护鞘的延伸方向间隔设置。可选地,多个第二磁性件212与多个第二电极211沿第二保护鞘的延伸方向交错布置,以使多个第二电极211间隔布置,即使用各个第二磁性件212隔开相应的两个第二电极211。Optionally, the plurality of second magnetic members 212 are all sleeved on the second protective sheath, and the plurality of second magnetic members 212 are arranged at intervals along the extending direction of the second protective sheath. Optionally, the plurality of second magnetic members 212 and the plurality of second electrodes 211 are alternately arranged along the extending direction of the second protective sheath, so that the plurality of second electrodes 211 are arranged at intervals, that is, each second magnetic member 212 is used to separate The corresponding two second electrodes 211 .
在本实施例中,第一保护鞘113的相对两侧均设置有遮挡侧檐115,以对第一保护鞘113内部的多个第一电极111和多个第一磁性件112均形成遮挡防护作用,以避免消融过程中心膜组织的血液等进入第一保护鞘113与心脏外膜之间的区域内而影响第一保护鞘113与心脏外膜之间的贴紧程度,避免消融时第一电极111和第二电极间211电阻值的测量精度,从而影响消融效果。另外,通过设置遮挡侧檐115,可遮挡消融线外的组织液及生理盐水等液体进入消融部位,避免消融时第一电极和第二电极间电阻值的测量精度,从而影响消融效果。In this embodiment, the opposite sides of the first protective sheath 113 are provided with shielding side eaves 115 to form shielding protection for the plurality of first electrodes 111 and the plurality of first magnetic members 112 inside the first protective sheath 113 . It can prevent the blood in the epicardial tissue from entering the area between the first protective sheath 113 and the epicardium during the ablation process and affect the tightness between the first protective sheath 113 and the epicardium, and avoid the first protective sheath 113 during ablation. The measurement accuracy of the resistance value between the electrode 111 and the second electrode 211 affects the ablation effect. In addition, by setting the shielding side eave 115, the tissue fluid outside the ablation line and liquids such as physiological saline can be shielded from entering the ablation site, so as to avoid the measurement accuracy of the resistance value between the first electrode and the second electrode during ablation, thereby affecting the ablation effect.
在本实施例中,遮挡侧檐115的一种设置方式为:如图3所示,遮挡侧檐115为 条形,遮挡侧檐115沿第一保护鞘113的延伸方向延伸。In this embodiment, an arrangement of the shielding side eave 115 is as follows: as shown in FIG.
在本实施例中,遮挡侧檐115的另一种设置方式为:如图4所示,遮挡侧檐115为多个,多个遮挡侧檐115沿第一保护鞘113的延伸方向布置并依次拼接。In this embodiment, another arrangement of the shielding side eaves 115 is as follows: as shown in FIG. 4 , there are multiple shielding side eaves 115 , and the plurality of shielding side eaves 115 are arranged along the extending direction of the first protective sheath 113 and in sequence stitching.
可选地,如图5所示,第一电极111和/或第一磁性件112上设置有用于容纳导线118的导线铺设槽120,导线118用于与第一电极111连接;或者,将用于铺设导线118的导线铺设槽120设置在第一保护鞘113的内壁上。Optionally, as shown in FIG. 5 , the first electrode 111 and/or the first magnetic member 112 is provided with a wire laying groove 120 for accommodating the wire 118, and the wire 118 is used to connect with the first electrode 111; The wire laying groove 120 for laying the wire 118 is provided on the inner wall of the first protective sheath 113 .
在本实施例中,如图8和图9所示,第二电极端头210包括第二保护鞘214,第二电极211设置在第二保护鞘214上;其中,第二电极端头210包括显影件213,显影件213设置在第二保护鞘214上,以通过显影件213标记第二电极端头210的位置;和/或,第二电极211由金属显影材料制成,金属显影材料包括以下材料中的至少一种:铂金、铂依合金、钽、镀金铍青铜;和/或,第二保护鞘214由显影材料制成,显影材料的制作材料包括硫酸钡(BaSO4)。In this embodiment, as shown in FIGS. 8 and 9 , the second electrode tip 210 includes a second protective sheath 214 , and the second electrode 211 is disposed on the second protective sheath 214 ; wherein the second electrode tip 210 includes The developing member 213, the developing member 213 is disposed on the second protective sheath 214, so as to mark the position of the second electrode end 210 by the developing member 213; and/or, the second electrode 211 is made of a metal developing material, and the metal developing material includes At least one of the following materials: platinum, platinum-based alloy, tantalum, gold-plated beryllium bronze; and/or, the second protective sheath 214 is made of a developing material, and the developing material is made of barium sulfate (BaSO4).
可选地,多个第二磁性件212与多个第二电极211均套设在第二保护鞘214上;可选地,多个第二磁性件212与多个第二电极211沿第二保护鞘的延伸方向交错布置,以使多个第二电极211间隔布置,即使用各个第二磁性件212隔开相应的两个第二电极211。Optionally, the plurality of second magnetic members 212 and the plurality of second electrodes 211 are sleeved on the second protective sheath 214; The extension directions of the protective sheaths are staggered, so that the plurality of second electrodes 211 are arranged at intervals, that is, each second magnetic member 212 is used to separate the corresponding two second electrodes 211 .
可选地,参照图13和图19,多个第二磁性件212与多个第二电极211均为环状结构。或为多边形、V型、D型、拱形等截面结构。如图19所示,第二电极211的截面为多边形,例如可为方形。Optionally, referring to FIGS. 13 and 19 , the plurality of second magnetic members 212 and the plurality of second electrodes 211 are both annular structures. Or polygonal, V-shaped, D-shaped, arched and other cross-sectional structures. As shown in FIG. 19 , the cross section of the second electrode 211 is a polygon, for example, a square.
本实施例中的显影件213、具有显影作用的第二电极211以及具有显影作用的第二保护鞘214可以在第二电极组件200进入消融部位时的位置指示。可选地,第二电极端头210上的显影件213的数量为3-6个,且可以单独设置也可以是第二电极211带有显影功能。本实施例中的显影件213和第二保护鞘214的鞘体外壁是平齐的,防止手术中对病人造成损伤。In this embodiment, the developing member 213 , the second electrode 211 with a developing function, and the second protective sheath 214 with a developing function can indicate the position of the second electrode assembly 200 when it enters the ablation site. Optionally, the number of the developing members 213 on the second electrode end 210 is 3-6, and the number of the developing members 213 may be set independently or the second electrode 211 may have a developing function. In this embodiment, the outer walls of the developing member 213 and the second protective sheath 214 are flush to prevent damage to the patient during the operation.
在本实施例中,显影件213可以没有,显影件213也可以为多个,多个显影件213沿第二保护鞘214的延伸方向间隔设置;和/或,第二保护鞘214的外表面分为与显影件213对应的部分形成第一表面部和与第一表面部连接的第二表面部,第一表面部为凹陷结构,显影件213套设在第一表面部上,显影件213的外表面与第二表面部平齐或低于第二表面部。In this embodiment, the developing member 213 may be absent, or there may be multiple developing members 213, and the multiple developing members 213 are arranged at intervals along the extending direction of the second protective sheath 214; and/or, the outer surface of the second protective sheath 214 The first surface portion and the second surface portion connected to the first surface portion are formed by dividing into a portion corresponding to the developing member 213. The first surface portion is a concave structure, and the developing member 213 is sleeved on the first surface portion. The developing member 213 The outer surface is flush with the second surface portion or lower than the second surface portion.
在工作时,首先将第一电极组件100通过定位件固定在心外膜上,接着第二电极 组件200进入心脏内部,通过显影件213的指示将第二电极组件200放置到心内膜中第一电极组件100对应的部位,然后同步、顺序开启位于第一电极端头110和第二电极端头210的第一对磁性件、第二对磁性件及第三对磁性件,此时两组电极完成初定位。完成初定位后的两个电极组件接着将其余的磁性件成对开启,完成最终的定位。During operation, the first electrode assembly 100 is first fixed on the epicardium through the positioning member, then the second electrode assembly 200 enters the heart, and the second electrode assembly 200 is placed in the endocardium through the indication of the developing member 213. At the corresponding part of the electrode assembly 100, the first pair of magnetic parts, the second pair of magnetic parts and the third pair of magnetic parts located at the first electrode end 110 and the second electrode end 210 are turned on synchronously and sequentially. At this time, two sets of electrodes Complete initial positioning. After completing the initial positioning, the two electrode assemblies then turn on the remaining magnetic parts in pairs to complete the final positioning.
可选地,第一电极111和第二电极211工作时是每对电极相对独立的,即可以控制工作电极的数量。Optionally, when the first electrode 111 and the second electrode 211 work, each pair of electrodes is relatively independent, that is, the number of working electrodes can be controlled.
在本实施例中,如图6所示,第一电极111具有朝向待消融部位设置的电极面1110,第一保护鞘113具有朝向待消融部位设置的保护鞘面1130;其中,电极面1110位于保护鞘面1130靠近待消融部位的一侧。In this embodiment, as shown in FIG. 6 , the first electrode 111 has an electrode surface 1110 disposed toward the site to be ablated, and the first protective sheath 113 has a protective sheath surface 1130 disposed toward the site to be ablated; wherein, the electrode surface 1110 is located on the The protective sheath surface 1130 is close to the side of the site to be ablated.
在本实施例中,第一电极111为多个,多个第一电极111沿第一电极端头110的延伸方向间隔布置;多个第一电极111的电极面1110与保护鞘面1130之间的最小距离均相同。第一电极111的电极面1110与保护鞘面1130之间的最小距离的取值范围0-0.5mm,存在此高度差可以使得第一电极111与被消融表面充分接触,保证消融效果。第一电极111的电极面1110与保护鞘面1130之间的高度差取值优先为0.2mm。In this embodiment, there are multiple first electrodes 111, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; between the electrode surfaces 1110 of the multiple first electrodes 111 and the protective sheath surface 1130 The minimum distances are the same. The value range of the minimum distance between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is 0-0.5 mm. The existence of this height difference can make the first electrode 111 fully contact the surface to be ablated to ensure the ablation effect. The height difference between the electrode surface 1110 of the first electrode 111 and the protective sheath surface 1130 is preferably 0.2 mm.
在本实施例中,电极面1110和保护鞘面1130均为平面。In this embodiment, the electrode surface 1110 and the protective sheath surface 1130 are both flat surfaces.
为了实现对第一电极端头110的冷却,如图6所示,第一电极111为多个,多个第一电极111沿第一电极端头110的延伸方向间隔布置;多个第一电极111中的至少一个第一电极111上设置有用于供冷却流体流通的冷却孔1112;和/或,第一保护鞘113内设置有供冷却流体流通的冷却管道。本实施例通过设置冷却孔1112,用于消融过程中局部的降温,用来保护消融部位之外的其他部位不被损伤。通过设置冷却通道,可以在电极侧边进行冷却。In order to achieve cooling of the first electrode tip 110, as shown in FIG. 6, there are multiple first electrodes 111, and the multiple first electrodes 111 are arranged at intervals along the extending direction of the first electrode tip 110; At least one of the first electrodes 111 in the 111 is provided with a cooling hole 1112 for circulating a cooling fluid; and/or a cooling pipe for circulating a cooling fluid is provided in the first protective sheath 113 . In this embodiment, the cooling holes 1112 are provided for local cooling during the ablation process, so as to protect other parts other than the ablation site from being damaged. By providing cooling channels, cooling can be performed on the sides of the electrodes.
在本实施例中,多个第一电极111中的至少一个第一电极111上设置有1至4个冷却孔1112。每个第一电极111上的冷却孔数量为0-4个,以保证消融过程中温度的控制。In this embodiment, at least one of the plurality of first electrodes 111 is provided with 1 to 4 cooling holes 1112 . The number of cooling holes on each first electrode 111 is 0-4 to ensure temperature control during ablation.
本公开还提供了一种射频消融设备,如图11所示,该射频消融设备包括射频主机310和上述的消融装置,该消融装置与射频主机310连接。The present disclosure also provides a radio frequency ablation device. As shown in FIG. 11 , 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 .
可选地,如图10所示,射频主机310上设置有显示屏313,显示屏313用于显示所测出的两个相对应的第一电极111和第二电极211之间被消融组织的阻抗和/或射频功率。Optionally, as shown in FIG. 10 , the radio frequency host 310 is provided with a display screen 313 , and the display screen 313 is used to display the measured values of the tissue to be ablated between the two corresponding first electrodes 111 and the second electrodes 211 . Impedance and/or RF Power.
可选地,射频主机310上还设置有消融接口311,第一电极组件100和第二电极 组件200均包括多个导线组件,各个导线组件包括导线接头和与导线接头连接的多个并联设置的导线,各个导线用于与相应的电极连接;消融接口311具有第一消融接口部和第二消融接口部,第一消融接口部具有用于供第一电极组件100的多个导线接头插入的多个第一消融接口,第二消融接口部具有用于供第二电极组件200的多个导线接头插入的多个第二消融接口,以通过各个第一消融接口和各个第二消融接口向相应的第一电极111和相应的第二电极211提供合适的射频功率。Optionally, the radio frequency host 310 is further provided with an ablation interface 311, the first electrode assembly 100 and the second electrode assembly 200 each include a plurality of lead assemblies, and each lead assembly includes a lead connector and a plurality of parallel connection connected to the lead connector. Lead wires, each lead wire is used to connect with the corresponding electrode; the ablation interface 311 has a first ablation interface part and a second ablation interface part, and the first ablation interface part has a plurality of lead wires for inserting the plurality of lead wires of the first electrode assembly 100. a first ablation interface, the second ablation interface part has a plurality of second ablation interfaces for inserting a plurality of lead wires of the second electrode assembly 200, so as to communicate with the corresponding The first electrode 111 and the corresponding second electrode 211 provide suitable radio frequency power.
可选地,当第一磁性件112和第二磁性件212均为电磁铁时,射频主机310上还设置有电磁接口312,第一电极组件100和第二电极组件200均包括多个电磁铁组件,各个电磁铁组件包括电磁接头和与电磁接头连接的多个并联设置的电磁线,各个电磁线用于与相应的电磁铁连接;电磁接口312具有第一电磁接口部和第二电磁接口部,第一电磁接口部具有用于供第一电极组件100的多个电磁接头插入的多个第一磁接口,第二电磁接口部具有用于供第二电极组件200的多个电磁接头插入的多个第二磁接口,以通过各个第一磁接口和各个第二磁接口向相应的第一磁性件112和相应的第二磁性件212供电,进而使相应的第一磁性件112和相应的第二磁性件212之间产生吸合力。Optionally, when the first magnetic member 112 and the second magnetic member 212 are both electromagnets, the radio frequency host 310 is further provided with an electromagnetic interface 312, and both the first electrode assembly 100 and the second electrode assembly 200 include a plurality of electromagnets. components, each electromagnet assembly includes an electromagnetic joint and a plurality of electromagnetic wires connected in parallel with the electromagnetic joint, and each electromagnetic wire is used to connect with 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 a plurality of first magnetic interfaces for inserting a plurality of electromagnetic joints of the first electrode assembly 100 , and the second electromagnetic interface part has a plurality of electromagnetic joints for inserting a plurality of electromagnetic joints of the second electrode assembly 200 a plurality of second magnetic interfaces, so as to supply power to the corresponding first magnetic member 112 and the corresponding second magnetic member 212 through each of the first magnetic An attraction force is generated between the second magnetic members 212 .
参照图12至15所示,可以看出本实施例中的消融装置对待消融组织340的消融原理,并可以体现消融装置的消融范围330。Referring to FIGS. 12 to 15 , it can be seen that the ablation device in this embodiment ablation principle of the tissue to be ablated 340 , and can reflect the ablation range 330 of the ablation device.
从以上的描述中,可以看出,本公开上述的实施例实现了如下技术效果:From the above description, it can be seen that the above-mentioned embodiments of the present disclosure achieve the following technical effects:
在本公开的电极组件中,该电极组件包括第一电极端头110,第一电极端头110包括第一保护鞘113以及设置在第一保护鞘113内的第一电极111和填充件116,通过填充件116对第一电极111进行挤压以使第一电极111朝向待消融组织移动,进而使第一电极111能够与第一保护鞘113的内壁贴合,而相对应的位置的第一保护鞘113的外壁与相应的待消融组织贴合,从而保证第一电极111能够较好地作用于相应的待消融组织,保证消融效果;可见,使用本电极组件能够解决现有技术中的内科介入式消融装置消融效果不理想的问题。In the electrode assembly of the present disclosure, the electrode assembly includes a first electrode tip 110, the first electrode tip 110 includes a first protective sheath 113, and a first electrode 111 and a filler 116 disposed in the first protective sheath 113, The first electrode 111 is squeezed by the filler 116 to move the first electrode 111 toward the tissue to be ablated, so that the first electrode 111 can fit with the inner wall of the first protective sheath 113, and the first electrode 111 at the corresponding position The outer wall of the protective sheath 113 is attached to the corresponding tissue to be ablated, so as to ensure that the first electrode 111 can better act on the corresponding tissue to be ablated and ensure the ablation effect; it can be seen that the use of this electrode assembly can solve the problems of internal medicine in the prior art. The problem of unsatisfactory ablation effect of interventional ablation device.
应用本公开的技术方案,该消融装置包括具有第一电极端头的第一电极组件和具有第二电极端头的第二电极组件。第一电极组件和第二电极组件可独立使用,第一电极端头包括第一保护鞘和设置于第一保护鞘的多个第一电极;并且,第一保护鞘为条形,多个第一电极沿第一保护鞘的延伸方向间隔布置,即通过多个第一电极同时作用于心外膜组织,以形成一条完整的消融线,当保护鞘使用柔性材质时,可以解决现有 外科器械使用时角度受限,手术操作不方便的问题。Applying the technical solutions of the present disclosure, the ablation device includes a first electrode assembly having a first electrode tip and a second electrode assembly having a second electrode tip. The first electrode assembly and the second electrode assembly can be used independently, and the first electrode tip includes a first protective sheath and a plurality of first electrodes disposed on the first protective sheath; An electrode is arranged at intervals along the extension direction of the first protective sheath, that is, a plurality of first electrodes act on the epicardial tissue at the same time to form a complete ablation line. When the protective sheath is made of flexible material, it can solve the problem of existing surgical instruments. The angle of use is limited and the surgical operation is inconvenient.
该消融装置第一电极和第二电极相对设置,以通过第一电极和第二电极对位于第一电极和第二电极之间的待消融组织进行消融。使用时,将第一电极组件和第二电极组件分别用作心外膜电极和心内膜电极,以使第一电极组件和第二电极组件分别作用于心外膜和心内膜,以实现同时消融心外膜和心内膜,从而实现良好的消融效果,解决内科介入消融能量恒定,无法适时根据消融效果调整输出功率,导致过烧或不透壁问题和心外科是动态消融,但外科消融创伤较大,术后恢复慢的问题;从而实现良好的消融效果,并提高消融效率;可见,使用本消融装置能够解决现有技术中的消融装置的消融效果不理想的问题。The first electrode and the second electrode of the ablation device are arranged opposite to each other, so that the tissue to be ablated located between the first electrode and the second electrode is ablated by the first electrode and the second electrode. When in 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, to achieve Simultaneously ablate the epicardium and endocardium to achieve a good ablation effect, solve the problem that the energy of medical interventional ablation is constant, and the output power cannot be adjusted according to the ablation effect in a timely manner, resulting in overburning or wall impermeability and cardiac surgery is dynamic ablation, but surgery The ablation trauma is relatively large and the postoperative recovery is slow; thereby achieving a good ablation effect and improving ablation efficiency; it can be seen that the use of the ablation device can solve the problem of unsatisfactory ablation effect of the ablation device in the prior art.
本公开的射频消融设备包括上述的消融装置,因此该射频消融设备至少具有与该消融装置相同的技术效果。The radio frequency ablation device of the present disclosure includes the above-mentioned ablation device, so the radio frequency ablation device has at least the same technical effect as the ablation device.
为了便于描述,在这里可以使用空间相对术语,如“在……之上”、“在……上方”、“在……上表面”、“上面的”等,用来描述如在图中所示的一个器件或特征与其他器件或特征的空间位置关系。应当理解的是,空间相对术语旨在包含除了器件在图中所描述的方位之外的在使用或操作中的不同方位。例如,如果附图中的器件被倒置,则描述为“在其他器件或构造上方”或“在其他器件或构造之上”的器件之后将被定位为“在其他器件或构造下方”或“在其他器件或构造之下”。因而,示例性术语“在……上方”可以包括“在……上方”和“在……下方”两种方位。该器件也可以其他不同方式定位(旋转90度或处于其他方位),并且对这里所使用的空间相对描述作出相应解释。For ease of description, spatially relative terms, such as "on", "over", "on the surface", "above", etc., may be used herein to describe what is shown in the figures. The spatial positional relationship of one device or feature shown to other devices or features. It should be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "above" or "over" other devices or features would then be oriented "below" or "over" the other devices or features under other devices or constructions". Thus, the exemplary term "above" can encompass both an orientation of "above" and "below." The device may also be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptions used herein interpreted accordingly.
需要注意的是,这里所使用的术语仅是为了描述具体实施方式,而非意图限制根据本公开的示例性实施方式。如在这里所使用的,除非上下文另外明确指出,否则单数形式也意图包括复数形式,此外,还应当理解的是,当在本说明书中使用术语“包含”和/或“包括”时,其指明存在特征、步骤、操作、器件、组件和/或它们的组合。It should be noted that the terminology used herein is for the purpose of describing specific embodiments only, and is not intended to limit the exemplary embodiments according to the present disclosure. As used herein, unless the context clearly dictates otherwise, the singular is intended to include the plural as well, furthermore, it is to be understood that when the terms "comprising" and/or "including" are used in this specification, it indicates that There are features, steps, operations, devices, components and/or combinations thereof.
需要说明的是,本公开的说明书和权利要求书及上述附图中的术语“第一”、“第二”等是用于区别类似的对象,而不必用于描述特定的顺序或先后次序。应该理解这样使用的数据在适当情况下可以互换,以便这里描述的本公开的实施方式例如能够以除了在这里图示或描述的那些以外的顺序实施。此外,术语“包括”和“具有”以及他们的任何变形,意图在于覆盖不排他的包含,例如,包含了一系列步骤或单元的过程、方法、系统、产品或设备不必限于清楚地列出的那些步骤或单元,而是可包括没 有清楚地列出的或对于这些过程、方法、产品或设备固有的其它步骤或单元。It should be noted that the terms "first", "second" and the like in the description and claims of the present disclosure and the above drawings are used to distinguish similar objects, and are not necessarily used to describe a specific sequence or sequence. It is to be understood that the data so used are interchangeable under appropriate circumstances such that the embodiments of the disclosure described herein can, for example, be practiced in sequences other than those illustrated or described herein. Furthermore, the terms "comprising" and "having" and any variations thereof, are intended to cover non-exclusive inclusion, for example, a process, method, system, product or device comprising a series of steps or units is not necessarily limited to those expressly listed Rather, those steps or units may include other steps or units not expressly listed or inherent to these processes, methods, products or devices.
以上所述仅为本公开的优选实施例而已,并不用于限制本公开,对于本领域的技术人员来说,本公开可以有各种更改和变化。凡在本公开的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本公开的保护范围之内。The above descriptions are only preferred embodiments of the present disclosure, and are not intended to limit the present disclosure. For those skilled in the art, the present disclosure may have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present disclosure shall be included within the protection scope of the present disclosure.

Claims (15)

  1. 一种电极组件,包括第一电极端头(110),所述第一电极端头(110)包括:An electrode assembly, comprising a first electrode tip (110), the first electrode tip (110) comprising:
    第一保护鞘(113);a first protective sheath (113);
    第一电极(111),所述第一电极(111)设置在所述第一保护鞘(113)内;a first electrode (111), the first electrode (111) is disposed in the first protective sheath (113);
    填充件(116),所述填充件(116)设置在所述第一保护鞘(113)内,以通过所述填充件(116)将所述第一保护鞘(113)内的所述第一电极(111)朝向待消融组织挤压。A filler (116), the filler (116) is arranged in the first protective sheath (113), so that the first protective sheath (113) is filled with the An electrode (111) is pressed towards the tissue to be ablated.
  2. 根据权利要求1所述的电极组件,其中,所述第一电极(111)为多个,所述第一保护鞘(113)为条形,多个所述第一电极(111)沿所述第一保护鞘(113)的延伸方向间隔布置。The electrode assembly according to claim 1, wherein there are a plurality of the first electrodes (111), the first protective sheath (113) is strip-shaped, and the plurality of the first electrodes (111) are along the The extending directions of the first protective sheaths (113) are arranged at intervals.
  3. 根据权利要求1或2所述的电极组件,其中,所述填充件(116)为条形,所述第一保护鞘(113)为条形,所述填充件(116)沿所述第一保护鞘(113)的延伸方向延伸。The electrode assembly according to claim 1 or 2, wherein the filler (116) is strip-shaped, the first protective sheath (113) is strip-shaped, and the filler (116) is along the first The extension direction of the protective sheath (113) extends.
  4. 根据权利要求1至3中任一项所述的电极组件,其中,所述填充件(116)为多个,所述第一保护鞘(113)为条形,多个所述填充件(116)沿所述第一保护鞘(113)的延伸方向间隔布置。The electrode assembly according to any one of claims 1 to 3, wherein there are a plurality of the fillers (116), the first protective sheath (113) is strip-shaped, and a plurality of the fillers (116) ) are arranged at intervals along the extending direction of the first protective sheath (113).
  5. 根据权利要求4所述的电极组件,其中,多个所述填充件(116)和多个所述第一电极(111)一一对应地设置,各个所述填充件(116)均设置在相应的所述第一电极(111)的远离所述待消融组织的一侧。The electrode assembly according to claim 4, wherein a plurality of the filling members (116) and a plurality of the first electrodes (111) are arranged in a one-to-one correspondence, and each of the filling members (116) is arranged in a corresponding The side of the first electrode (111) away from the tissue to be ablated.
  6. 根据权利要求2至5中任一项所述的电极组件,其中,多个所述第一电极(111)的通电电路独立设置,以单独控制各个所述第一电极(111)。The electrode assembly according to any one of claims 2 to 5, wherein the energization circuits of the plurality of first electrodes (111) are independently provided to individually control each of the first electrodes (111).
  7. 根据权利要求4至6中任一项所述的电极组件,其中,多个所述填充件(116)的通气管路独立设置,以单独控制各个所述填充件(116)的充气状态。The electrode assembly according to any one of claims 4 to 6, wherein the ventilation lines of a plurality of the filling members (116) are independently provided, so as to individually control the inflation state of each of the filling members (116).
  8. 根据权利要求1至7中任一项所述的电极组件,其中,所述填充件(116)为气囊结构或者所述填充件(116)为柔性块。The electrode assembly according to any one of claims 1 to 7, wherein the filler (116) is a balloon structure or the filler (116) is a flexible block.
  9. 根据权利要求1至8中任一项所述的电极组件,其中,所述第一保护鞘(113)上设置有用于避让所述第一电极(111)的开孔结构,以使所述第一电极(111)的部分结构经所述开孔结构由所述第一保护鞘(113)的腔体伸出。The electrode assembly according to any one of claims 1 to 8, wherein the first protective sheath (113) is provided with an opening structure for avoiding the first electrode (111), so that the first protective sheath (113) is A part of the structure of an electrode (111) protrudes from the cavity of the first protective sheath (113) through the opening structure.
  10. 根据权利要求9所述的电极组件,其中,所述第一电极(111)为多个,所述开孔结构包括多个避让开孔,多个所述避让开孔与多个所述第一电极(111)一一对应地设置,以使各个所述第一电极(111)的部分结构通过相应的所述避让开孔伸出至所述第一保护鞘(113)的外侧。The electrode assembly according to claim 9, wherein there are a plurality of the first electrodes (111), the opening structure comprises a plurality of avoidance holes, a plurality of the avoidance holes and a plurality of the first electrodes The electrodes (111) are arranged in a one-to-one correspondence, so that part of the structure of each of the first electrodes (111) protrudes to the outside of the first protective sheath (113) through the corresponding avoidance holes.
  11. 根据权利要求9或10所述的电极组件,其中,所述第一电极(111)为多个,所述开孔结构为条形开口,所述条形开口沿所述第一保护鞘(113)的延伸方向间隔,多个所述第一电极(111)的部分结构通过所述条形开口伸出至所述第一保护鞘(113)的外侧。The electrode assembly according to claim 9 or 10, wherein there are a plurality of the first electrodes (111), the opening structure is a strip-shaped opening, and the strip-shaped opening is along the first protective sheath (113) ) in the extending direction, and the partial structures of the plurality of first electrodes (111) protrude to the outside of the first protective sheath (113) through the strip-shaped openings.
  12. 一种消融装置,包括第一电极组件(100)和第二电极组件(200),其中,所述第一电极组件(100)为权利要求1至11中任一项所述的电极组件,所述第二电极组件(200)包括第二电极端头(210),所述第二电极端头(210)包括第二电极(211),所述第二电极(211)与所述第一电极(111)相对设置,以通过所述第一电极(111)和所述第二电极(211)对位于所述第一电极(111)和所述第二电极(211)之间的待消融组织进行消融。An ablation device, comprising a first electrode assembly (100) and a second electrode assembly (200), wherein the first electrode assembly (100) is the electrode assembly according to any one of claims 1 to 11, wherein The second electrode assembly (200) includes a second electrode tip (210), the second electrode tip (210) includes a second electrode (211), the second electrode (211) and the first electrode (111) are arranged opposite to each other, so that the tissue to be ablated between the first electrode (111) and the second electrode (211) is paired with the first electrode (111) and the second electrode (211) Perform ablation.
  13. 根据权利要求12所述的消融装置,其中,所述第二电极端头(210)包括第二保护鞘,所述第二电极(211)为多个,多个所述第二电极(211)套设在所述第二保护鞘上;其中,多个所述第一电极(111)和多个所述第二电极(211)相互配合地设置。The ablation device according to claim 12, wherein the second electrode tip (210) comprises a second protective sheath, the second electrodes (211) are plural, and the second electrodes (211) are plural The utility model is sleeved on the second protective sheath; wherein, the plurality of first electrodes (111) and the plurality of second electrodes (211) are arranged in cooperation with each other.
  14. 根据权利要求12或13所述的消融装置,其中,所述消融装置还包括:The ablation device of claim 12 or 13, wherein the ablation device further comprises:
    消融电路(320),所述第一电极(111)和所述第二电极(211)均设置在所述消融电路(320)上,以通过测试所述第一电极(111)和相应的所述第二电极(211)之间的阻抗调整所述第一电极(111)和所述第二电极(211)之间的射频能量来进行消融。The ablation circuit (320), the first electrode (111) and the second electrode (211) are both arranged on the ablation circuit (320), so as to pass the test of the first electrode (111) and the corresponding all the The impedance between the second electrodes (211) adjusts the radio frequency energy between the first electrodes (111) and the second electrodes (211) to perform ablation.
  15. 一种射频消融设备,包括射频主机(310)和与所述射频主机(310)连接的消融装置,其中,所述消融装置为权利要求12至14中任一项所述的消融装置。A radio frequency ablation device, comprising a radio frequency host (310) and an ablation device connected to the radio frequency host (310), wherein the ablation device is the ablation device according to any one of claims 12 to 14.
PCT/CN2021/132424 2021-01-08 2021-11-23 Electrode assembly, ablation device and radiofrequency ablation apparatus WO2022148159A1 (en)

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US20030153905A1 (en) * 2002-01-25 2003-08-14 Edwards Stuart Denzil Selective ablation system
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CN107184270A (en) * 2017-05-05 2017-09-22 上海安臻医疗科技有限公司 A kind of adherent feedback method of radio frequency ablation system
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