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WO2022148153A1 - Ensemble électrode, dispositif d'ablation et appareil d'ablation par radiofréquence - Google Patents

Ensemble électrode, dispositif d'ablation et appareil d'ablation par radiofréquence Download PDF

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Publication number
WO2022148153A1
WO2022148153A1 PCT/CN2021/132340 CN2021132340W WO2022148153A1 WO 2022148153 A1 WO2022148153 A1 WO 2022148153A1 CN 2021132340 W CN2021132340 W CN 2021132340W WO 2022148153 A1 WO2022148153 A1 WO 2022148153A1
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WIPO (PCT)
Prior art keywords
electrode
ablation
electrode assembly
electrodes
wire
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Application number
PCT/CN2021/132340
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English (en)
Chinese (zh)
Inventor
马志伟
王宇
申佳佳
马帅
周庆亮
孟坚
张立清
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beijing Med Zenith Medical Scientific Co Ltd
Original Assignee
Beijing Med Zenith Medical Scientific Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202120048218.XU external-priority patent/CN215349405U/zh
Priority claimed from CN202110026529.0A external-priority patent/CN114748152A/zh
Application filed by Beijing Med Zenith Medical Scientific Co Ltd filed Critical Beijing Med Zenith Medical Scientific Co Ltd
Publication of WO2022148153A1 publication Critical patent/WO2022148153A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical 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
    • A61B18/14—Probes or electrodes therefor

Definitions

  • the present disclosure is based on a Chinese patent application with an application number of 202110026529.0, 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 202120048218.X, with an application date of 2021 On January 8, a Chinese patent application entitled “Electrode Assembly, Ablation Device, and Radio Frequency Ablation Device” was published as the basis, and priority is claimed, 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 radiofrequency ablation device, so as to solve the problems of current surgical ablation trauma, slow postoperative recovery, limited angle of use, and inconvenient operation; to solve the problems of current medical intervention
  • the ablation energy is constant, and the output power cannot be adjusted according to the ablation effect in a timely manner, resulting in the problem of overburning or impermeability. It solves the problem that the current medical and surgical ablation equipment requires additional instruments for mapping after ablation, and the operation is cumbersome.
  • an electrode assembly which includes: an electrode tip, the electrode tip includes a support member and a plurality of electrodes arranged on the support member, the support member is strip-shaped, and the plurality of electrodes are arranged on the support member.
  • the electrodes are arranged at intervals along the extending direction of the support; the pulling wire assembly is connected with the electrode end, so that the electrode end is bent or in a straight state by pulling the pulling wire assembly.
  • the support member is tubular, and the pulling wire assembly is passed through the lumen of the support member.
  • the plurality of electrodes are distributed along the extension direction of the support; the pull wire assembly is connected to the end of the support or an electrode located at the end of the plurality of electrodes; or the electrode end further includes a magnetic member, and the magnetic member is arranged on the support.
  • the lumen or sleeve is set on the support member; wherein, the pull wire assembly is connected with the magnetic member.
  • the electrode tip further includes a tip piece, which is detachably arranged at the end of the support member; the pull wire assembly is connected to the tip piece.
  • the pulling wire assembly includes a plurality of pulling wires, and the plurality of pulling wires are arranged at intervals along the extending direction perpendicular to the electrode end; each pulling wire is connected with one end of the electrode end, so as to pull the electrode end to bend through the cooperation between the plurality of pulling wires. or in a straightened state.
  • the pulling wire assembly includes: a first pulling wire, a second pulling wire and a third pulling wire, the first pulling wire, the second pulling wire and the third pulling wire are all connected with one end of the electrode tip; the second pulling wire is located on the first pulling wire and the third pulling wire In between, the center line of the second pulling wire coincides with the center line of the support.
  • the support member is a tube body
  • the electrodes are arranged in the lumen of the support member
  • the electrode tip further includes a magnetic member arranged in the lumen of the support member; the electrodes and/or the magnetic members are provided with first spaced and arranged first In the avoidance opening, the second avoidance opening and the third avoidance opening, the first pull wire is passed through the first avoidance opening, the second pulley is passed through the second avoidance opening, and the third pulley is passed through the third avoidance opening.
  • the magnetic member is spaced apart and insulated from the electrode.
  • first avoidance opening, the second avoidance opening and the third avoidance opening are all cylindrical holes; or, the second avoidance opening is a cylindrical hole, and the first avoidance opening and the third avoidance opening are groove structures.
  • the electrode assembly also includes an operation handle, the operation handle is connected with the electrode terminal, the operation handle is provided with a first direction control button and a second direction control button, and the first direction control button is connected with the first pull wire and the third pull wire.
  • the first pull wire and the third pull wire are pulled by pushing the first direction control button; the second direction control button is connected with the second pull wire to pull the second pull wire by pushing the second direction control button.
  • the first directional control button includes a first operation part and a second operation part, the first operation part is connected with the first pull wire, and the second operation part is connected with the third pull wire, so as to push the first operation part and the second pull wire respectively.
  • the operation part pulls the first pull wire and the third pull wire.
  • the support member is tubular
  • the pull wire assembly includes a fourth pull wire
  • the fourth pull wire is arranged in the lumen of the support member, and the center line of the fourth pull wire deviates from the center line of the support member.
  • the electrode tip further includes a magnetic piece, the electrode and the magnetic piece are both annular structures or D-shaped structures, and the electrodes and the magnetic piece are sleeved on the support piece.
  • the electrode assembly also includes an operation handle and a push-pull part, the push-pull part is movably arranged on the operation handle; the push-pull part is connected with the support, the fourth pull wire is connected with the operation handle, and the push-pull part is moved relative to the operation handle by operating the push-pull part. , to pull the electrode tip to bend or straighten the electrode tip.
  • an ablation device which includes a first electrode assembly and a second electrode assembly, the first electrode assembly is the above-mentioned electrode assembly, and the second electrode assembly is the above-mentioned electrode assembly; the first electrode The electrodes of the assembly are arranged opposite to the electrodes of the second electrode assembly, so that the tissue to be ablated located between the electrodes of the first electrode assembly and the electrodes of the second electrode assembly is subjected to ablation by the electrodes of the first electrode assembly and the electrodes of the second electrode assembly. ablation.
  • the ablation device further includes an ablation circuit, and the electrodes of the first electrode assembly and the electrodes of the second electrode assembly are both arranged on the ablation circuit, so as to adjust the radio frequency between the two electrodes by testing the impedance between the two opposite electrodes. energy for ablation.
  • the energization circuits of the electrodes of the two first electrode assemblies 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 after ablation;
  • there are multiple electrodes of the second electrode assembly and the energization circuits of the electrodes of the two second electrode assemblies 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 to be ablated after ablation and/or, the energization circuits of the electrodes of the first electrode assembly and the electrodes of the second electrode assembly are independently arranged to form a mapping electrode pair, so as to use the energization circuit to detect the transmission of electrical signals after ablation of the tissue to be ablated.
  • a radio frequency ablation apparatus which includes a radio frequency host and the above-mentioned ablation device, the ablation device is connected to the radio frequency host.
  • the radio frequency host is provided with a display screen and an ablation interface, and the display screen is used to display the measured impedance and/or radio frequency power between the two opposite electrodes;
  • the first electrode assembly and the second electrode assembly include a plurality of wires Assemblies, each lead assembly includes a lead joint and a plurality of parallel wires connected to the lead joint, each lead is used for connecting with a corresponding electrode;
  • the ablation interface has a first ablation interface part and a second ablation interface part, the first ablation interface
  • the second ablation interface portion has a plurality of second ablation ports for insertion of the plurality of wire terminals of the second electrode assembly.
  • the radio frequency host is provided with an electromagnetic interface
  • the first magnetic member of the first electrode assembly and the second magnetic member of the second electrode assembly of the ablation device are both electromagnetic members
  • the first magnetic member and the second magnetic member include a plurality of magnetic members.
  • Wire assemblies, each wire assembly includes wire joints and a plurality of parallel wires connected to the wire joints, each wire is used to connect with a corresponding magnetic component
  • the electromagnetic interface has a first electromagnetic interface part and a second electromagnetic interface part, the first electromagnetic interface part
  • the electromagnetic interface portion has a plurality of first electromagnetic interfaces into which the plurality of wire terminals of the first magnetic member are inserted.
  • first electrode assembly and the second electrode assembly of the ablation device work independently of each other to respectively ablate the tissue to be ablated in contact with the first electrode assembly and the tissue to be ablated in contact with the second electrode assembly.
  • the electrode assembly includes an electrode tip and a pulling wire assembly
  • the electrode tip includes a support member and a plurality of electrodes arranged on the support member, the support member is strip-shaped, and the plurality of electrodes are along the extension direction of the support member Spaced arrangement; that is, multiple electrodes act on the corresponding endocardium or epicardial tissue to be ablated at the same time to form a complete ablation line to ensure the ablation effect and improve the ablation efficiency. Avoid mutual influence between two adjacent electrodes; the pulling wire assembly is connected with the electrode tip, so that the electrode tip can be bent or in a straight state by pulling the pulling wire assembly, so that the electrode tip can form a good contact with the tissue to be ablated.
  • the fit effect solves the problem of the limited angle of the current surgical ablation instrument products, thereby ensuring that each electrode can better act on the corresponding tissue to be ablated to ensure the ablation effect; it can be seen that the use of this electrode assembly can solve the problem in the prior art.
  • the ablation effect of the ablation device is not ideal.
  • electrode assemblies can be placed on the endocardium and the epicardium at the same time, and the electrodes are arranged opposite to each other, so as to ablate the tissue to be ablated between the electrodes through the electrodes of different electrode assemblies.
  • the first electrode assembly is placed on the epicardium and the second electrode assembly is placed on the endocardium, so that the first electrode assembly and the second electrode assembly act on the epicardium and the endocardium respectively, so as to realize the simultaneous ablation of the epicardium. and endocardium, to solve the problem that the energy of interventional ablation in internal medicine is constant, and the output power cannot be adjusted according to the ablation effect in a timely manner, resulting in the problem of overburning or impermeability.
  • a single electrode assembly or a working electrode assembly can perform timely mapping to monitor the ablation effect. And it is the problem of point-like mapping, which improves the effect of surgical ablation.
  • FIG. 1 shows a schematic structural diagram of an electrode assembly according to some embodiments of the present disclosure
  • FIG. 2 shows a schematic diagram of the internal structure of the electrode assembly in FIG. 1;
  • FIG. 3 shows a schematic diagram of the structural arrangement of the electrode assembly in FIG. 1 with a snap-fit positioning member
  • FIG. 4 shows an internal cross-sectional view of the structure of the electrode assembly in FIG. 3 with a pull-in positioning member
  • FIG. 5 shows a schematic diagram of a structural arrangement of the electrode assembly in FIG. 1 with an extrusion positioning member
  • Figure 6 shows an internal cross-sectional view of the electrode assembly of Figure 1 with an extruded locator
  • FIG. 7 shows a schematic diagram of the structural arrangement of the electrode assembly in FIG. 1 with fillers
  • Fig. 8 shows a schematic diagram of a structure arrangement of the wire laying groove of the electrode assembly in Fig. 1;
  • FIG. 9 shows a schematic structural diagram of an electrode assembly according to other embodiments of the present disclosure.
  • Fig. 10 shows a schematic diagram of the internal structure of the electrode assembly in Fig. 9;
  • FIG. 11 shows a schematic diagram of the structural arrangement of the fourth pull wire of the electrode assembly in FIG. 9;
  • FIG. 12 shows a schematic structural diagram of a radio frequency host of an optional radio frequency ablation device according to the present disclosure
  • FIG. 13 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. 14 shows a schematic diagram of the ablation device in the present disclosure when the tissue to be ablated is ablated
  • FIG. 15 shows a diagram of the cooperation between the first electrode and the second electrode and the tissue to be ablated in some embodiments of the ablation device of the present disclosure
  • FIG. 16 shows a schematic diagram of ablation in one state of the ablation device of the present disclosure
  • FIG. 17 shows a schematic diagram of an ablation of another state of the ablation device of the present disclosure.
  • FIG. 18 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. 19 shows a schematic structural diagram of other embodiments of the first electrode assembly of the ablation device of the present disclosure.
  • FIG. 20 shows a schematic structural diagram of other embodiments of the second electrode assembly of the ablation device of the present disclosure.
  • FIG. 21 shows a diagram showing the cooperation between the first electrode and the second electrode and the tissue to be ablated in other embodiments of the ablation device of the present disclosure.
  • suction positioning member 4171, suction inner wall; 4172, suction outer wall; 4173, suction cavity;
  • pull wire assembly 421, first pull wire; 422, second pull wire; 423, third pull wire; 424, fourth pull wire;
  • radio frequency host 311, ablation interface; 312, electromagnetic interface; 313, display screen; 320, ablation circuit; 330, ablation range; 340, tissue to be ablated;
  • the second electrode 110, the first electrode tip; 210, the second electrode tip; 211, the second electrode; 212, the second magnetic member; 111, the first electrode; 112, the second electrode.
  • the electrode assembly includes an electrode tip 410 and a pulling wire assembly 420
  • the electrode tip 410 includes a support member 413 and a plurality of electrodes 411 disposed on the support member 413
  • the support member 413 is strip-shaped, and a plurality of electrodes 411 are arranged at intervals along the extending direction of the support member 413
  • the pulling wire assembly 420 is connected with the electrode end 410, so that the electrode end 410 is bent or in a straight state by pulling the pulling wire assembly 420 .
  • the electrode assembly includes an electrode tip 410 and a pulling wire assembly 420.
  • the electrode tip 410 includes a support member 413 and a plurality of electrodes 411 arranged on the support member 413.
  • the electrodes 411 are arranged at intervals along the extending direction of the support 413; that is, a plurality of electrodes 411 act on the corresponding tissue to be ablated at the same time to form a complete ablation line to ensure the ablation effect and improve the ablation efficiency, so that the multiple electrodes 411 are arranged at intervals to avoid mutual influence between two adjacent electrodes 411;
  • the pulling wire assembly 420 is connected to the electrode end 410, so that the electrode end 410 is bent or in a straight state by pulling the pulling wire assembly 420, so that the electrode end
  • the head 410 can form a good fit effect with the tissue to be ablated, thereby ensuring that each electrode 411 can better act on the corresponding tissue to be ablated to ensure the ablation effect; it can be seen that the use of
  • the support member 413 is tubular, and the pulling wire assembly 420 is passed through the lumen of the support member 413 , so that when the pulling wire assembly 420 is pulled, the support member 413 is bent or is in a straight state, so that the support member 413 A good fit effect can be formed with the tissue to be ablated, so that each electrode 411 can better act on the corresponding tissue to be ablated.
  • the plurality of electrodes 411 are distributed along the extending direction of the support member 413; the pulling wire assembly 420 is connected to the end of the support member 413 or the electrode 411 located at the end of the plurality of electrodes 411.
  • the electrode tip 410 further includes a tip piece, which is detachably disposed at the end of the support member 413; the pulling wire assembly 420 is connected with the tip piece.
  • the pulling wire assembly 420 includes a plurality of pulling wires, and the plurality of pulling wires are arranged at intervals along the extending direction perpendicular to the electrode tip 410; The electrode tip 410 is bent or is in a straightened state in cooperation with the pulling.
  • each pull wire is connected to the end piece of the electrode tip 410 .
  • the electrode assembly provided in some embodiments is the electrode assembly shown in FIGS. 1 to 8 .
  • the support 413 is a tubular body.
  • the pulling wire assembly 420 includes a first pulling wire 421 , a second pulling wire 422 and a third pulling wire 423 .
  • the first pulling wire 421 , the second pulling wire 422 and the third pulling wire 423 are all connected to one end of the electrode terminal 410 .
  • the second pulling wire 422 is located between the first pulling wire 421 and the third pulling wire 423, and the center line of the second pulling wire 422 coincides with the center line of the support member 413, so that when the second pulling wire 422 is pulled, the electrode tip 410 is in a straightened position At this time, neither the first pull wire 421 nor the third pull wire 423 can be pulled.
  • the first pulling wire 421 and the third pulling wire 423 are located on two sides of the center line of the support member 413 respectively, so that when the first pulling wire 421 and the third pulling wire 423 are pulled, respectively, the electrode tip 410 is bent in opposite directions.
  • the first pull wire 421 , the second pull wire 422 and the third pull wire 423 are all connected to the end piece of the electrode tip 410 .
  • the plurality of electrodes 411 are disposed within the lumen of the support 413 .
  • the electrode tip 410 further includes a magnetic member 412 disposed in the lumen of the support member 413 , and the magnetic member 412 is used for positioning the electrode tip 410 .
  • the electrode 411 and/or the magnetic member 412 are provided with a first avoidance opening 431 , a second avoidance opening 432 and a third avoidance opening 433 which are arranged at intervals in sequence, and the first pull wire 421 passes through the It is arranged in the first avoidance opening 431 , the second pull wire 422 is passed through the second avoidance opening 432 , and the third pull wire 423 is passed through the third avoidance opening 433 .
  • each electrode 411 When there are a plurality of electrodes 411 , each electrode 411 is provided with a first avoidance opening 431 , a second avoidance opening 432 and a third avoidance opening 433 which are arranged at intervals in sequence; when there are multiple magnetic members 412 , each of the magnetic members 412 is A first avoidance opening 431 , a second avoidance opening 432 and a third avoidance opening 433 are provided in sequence and spaced apart.
  • the first pull wires 421 are sequentially passed through the first avoidance openings 431 of the plurality of electrodes 411 and/or the first avoidance openings 431 of the plurality of magnetic members 412 ; the second pull wires 422 are successively passed through the second avoidance openings of the plurality of electrodes 411 .
  • the openings 432 and/or the second avoidance openings 432 of the plurality of magnetic members 412; the third pull wires 423 are sequentially passed through the third avoidance openings 433 of the plurality of electrodes 411 and/or the third avoidance openings 433 of the plurality of magnetic members 412 Inside.
  • the magnetic member 412 is spaced apart and insulated from the electrode 411 .
  • the first avoidance opening 431, the second avoidance opening 432 and the third avoidance opening 433 are all cylindrical holes; or, the second avoidance opening 432 is a cylindrical hole, and the first avoidance opening 431 and the third avoidance opening 433 are both. groove structure.
  • the electrode assembly further includes an operation handle 460, which is connected to the electrode end 410.
  • the operation handle 460 is provided with a first direction control button 461 and a second direction control button 462.
  • the first direction control button 461 is connected with the first direction control button 461.
  • a pull wire 421 and a third pull wire 423 are both connected to pull the first pull wire 421 and the third pull wire 423 by pushing the first direction control button 461;
  • the second direction control button 462 is connected to the second pull wire 422 to control the second pull wire by pushing the second direction
  • the button 462 pulls the second pull wire 422 .
  • the two ends of the first pull wire 421 are respectively connected with the first direction control button 461 and the end piece of the electrode terminal 410
  • the two ends of the third pull wire 423 are respectively connected with the first direction control button 461 and the end of the electrode terminal 410
  • the two ends of the second pull wire 422 are respectively connected with the second direction control button 462 and the end piece of the electrode terminal 410 .
  • the tip piece is located at one end of the electrode tip 410 away from the operating handle 460 .
  • the first direction control button 461 includes a first operation part and a second operation part, the first operation part is connected with the first pull wire 421, and the second operation part is connected with the third pull wire 423, so as to push the first pull wire 423 respectively.
  • An operation part and a second operation part pull the first pull wire 421 and the third pull wire 423 .
  • each magnetic member 412 is used to separate the corresponding of the two electrodes 411.
  • the opposite sides of the support member 413 are provided with shielding side eaves 415 to form shielding protection for the plurality of electrodes 411 and the plurality of magnetic members 412 inside the support member 413 , In order to avoid the blood and the like of the epicardial tissue from entering into the area between the support member 413 and the epicardium during the ablation process, thereby affecting the closeness between the support member 413 and the epicardium.
  • the blocking side eaves 415 are strip-shaped, and the blocking side eaves 415 extend along the extending direction of the support member 413 .
  • the electrode assembly further includes a suction positioning member 417 , and the suction positioning member 417 is disposed on the support member 413 , so that the support member 413 is positioned on the tissue to be ablated by the suction positioning member 417 .
  • the suction positioning members 417 are arranged in pairs, and each pair of suction positioning members 417 works relatively independently during operation, that is, the number of suction positioning members to work can be determined according to actual needs.
  • the suction positioning member 417 is a suction cup structure.
  • the suction positioning member 417 includes a suction inner wall 4171 and a suction outer wall 4172, and a suction cavity 4173 is formed between the suction inner wall 4171 and the suction outer wall 4172, and a suction cavity 4173 is formed between the suction inner wall 4171 and the suction outer wall 4172.
  • the first suction port 4174 and the second suction port 4175 communicate with the suction cavity 4173 , and the orientation of the first suction port 4174 and the second suction port 4175 is the same.
  • Both the suction inner wall 4171 and the suction inner wall 4171 are U-shaped structures, and the suction inner wall 4171 and the suction outer wall 4172 are arranged around the support 413 .
  • the suction positioning member 417 further includes an air flow channel 4176 , and the air outlet end of the air flow channel 4176 is communicated with the suction cavity 4173 , so as to fill and draw air into the suction cavity 4173 through the air flow channel 4176 .
  • pull-in positioning members 417 there are multiple pull-in positioning members 417 .
  • an arrangement of the plurality of suction positioning members 417 is: the plurality of suction positioning members 417 are arranged at intervals along the extending direction of the support member 413, so that the support member 413 is stably positioned on the tissue to be ablated , to ensure the positioning effect of the support member 413 .
  • another arrangement of the multiple suction positioning members 417 is: as shown in FIG. 3 , the multiple suction positioning members 417 are arranged in pairs, and the paired two suction positioning members 417 are respectively They are arranged on opposite sides of the support member 413 to ensure a good fit between both sides of the support member 413 and the tissue to be ablated, so that the corresponding electrodes 411 can better act on the corresponding ablated tissue. tissue to ensure the ablation effect.
  • a plurality of pairs of suction positioning members 417 are arranged at intervals along the extending direction of the support member 413, so that the support member 413 is stably positioned on the tissue to be ablated, and the positioning effect of the support member 413 is ensured, thereby ensuring the gap between the support member 413 and the tissue to be ablated. Therefore, each electrode 411 can better act on its corresponding tissue to be ablated, so as to ensure the ablation effect.
  • the electrode assembly further includes an extrusion positioning member 414 , at least a part of the extrusion positioning member 414 is located outside the support member 413 , and at least a part of the extrusion positioning member 414 can be It is configured to expand and contract, so as to squeeze the support member 413 on the tissue to be ablated when the squeeze positioning member 414 expands.
  • the extrusion positioning member 414 is an airbag structure.
  • the ablation device in some embodiments ablation principle of the tissue 340 to be ablated, and the ablation range 330 of the ablation device can be embodied.
  • the multiple extrusion positioning members 414 are arranged at intervals along the extending direction of the support member 413, so that the multiple extrusion positioning members 414 all form a extrusion effect on the support member 413, so as to
  • the support member 413 has a good fit with the tissue to be ablated, thereby ensuring the fit effect of the support member 413 and the tissue to be ablated.
  • an arrangement of the pressing and positioning member 414 is as follows: as shown in FIG. 5 , an accommodating groove is provided on the outer wall of the supporting member 413 .
  • an accommodating groove is provided on the outer wall of the supporting member 413 .
  • the airbag structure is accommodated in the accommodating groove.
  • the airbag structure is in the expanded state, at least part of the airbag structure is released from the accommodating groove to form a pressing effect on the support member 413 .
  • a plurality of accommodating grooves are provided on the outer wall of the supporting member 413 , and the plurality of accommodating grooves are arranged at intervals along the extending direction of the supporting member 413 .
  • another arrangement of the extrusion positioning member 414 is as follows: the sheath wall of the support member 413 is provided with an escape hole, and when the airbag structure is in a contracted state, the airbag structure is accommodated in the cavity of the support member 413; When the airbag structure is in the inflated state, at least part of the airbag structure protrudes to the outside of the support member 413 through the escape hole to form a pressing effect on the support member 413 .
  • a positioning groove for accommodating the airbag structure is provided on the electrode 411 and/or the magnetic member 412 .
  • the electrode assembly further includes a filler 416 , the filler 416 is disposed in the cavity of the support 413 , and at least a part of the filler 416 is configured to be expandable and contractible, so as to orient the electrode 411 toward the filler 416 when the filler 416 expands.
  • the tissue to be ablated is squeezed.
  • the electrode 411 is squeezed by the filler 416 to move the electrode 411 toward the part to be ablated, so that the electrode 411 can fit with the inner wall of the support member 413, and the outer wall of the support member 413 at the corresponding position is
  • the corresponding parts to be ablated are adhered to ensure that the electrodes 411 can better act on the corresponding parts to be ablated, and the ablation effect is ensured.
  • a structural form of the filler 416 is as follows: as shown in FIG. 7 , the filler 416 is strip-shaped, and the filler 416 extends along the extension direction of the support 413 .
  • the filler 416 is a balloon structure, so as to form a squeezing effect on the plurality of electrodes 411 when the balloon structure is inflated and expanded.
  • another structural form of the filler 416 is: there are multiple fillers 416, and the multiple fillers 416 are arranged at intervals along the extending direction of the support 413; the multiple fillers 416 and the multiple electrodes 411 are one Each filler 416 is arranged correspondingly so that each filler 416 can form a pressing effect on the corresponding electrode 411; When the electrodes 411 of the electrodes 411 form a squeezing effect, each electrode 411 moves toward the direction of approaching the corresponding tissue to be ablated.
  • each filling member 416 is an airbag structure, so that when the airbag structure is inflated and inflated, the corresponding electrode 411 is squeezed.
  • the support member 413 is provided with a first opening opening for avoiding the electrode 411 , and a part of the structure of the electrode 411 protrudes from the first opening opening to the outside of the support member 413 , and protrudes from the support member 413
  • This part of the electrode structure on the outside can be in contact with the corresponding part to be ablated, so that this part of the electrode structure directly acts on the corresponding part to be ablated, and at the same time, the electrode structure located in the support 413 also acts on the corresponding part to be ablated, and then It is ensured that the electrode 411 can better act on the corresponding part to be ablated, so as to ensure the ablation effect and improve the ablation efficiency.
  • the supporting member 413 is also provided with a second opening for avoiding the magnetic member 412.
  • Part of the structure of the magnetic member 412 protrudes from the second opening to the outside of the supporting member 413.
  • Part of the magnetic parts 412 can be in direct contact with the parts to be fixed, and at the same time, the magnetic parts 412 located in the support parts 413 also cooperate with the parts to be fixed, so that the positioning effect between the support parts 413 and the parts to be fixed is more stable, which helps In order to make the electrode 411 perform ablation stably to ensure the ablation effect.
  • the electrode 411 and/or the magnetic member 412 is provided with a wire laying groove 450 for accommodating the wire 418 , and the wire 418 is used for connecting with the electrode 411 ; or, A wire laying groove 450 for laying the wire 418 is provided on the inner wall of the support member 413 .
  • the electrode assembly provided in some embodiments is the electrode assembly shown in FIGS. 9 to 11 .
  • the puller wire assembly 420 includes a fourth puller wire 424, the fourth puller wire 424 is disposed in the lumen of the support member 413, and the centerline of the fourth puller wire 424 is offset from the centerline of the support member 413, so as to pull the fourth puller wire At 424, the electrode tip 410 is bent or in a straightened state.
  • the electrode tip further includes a magnetic member 412 , the electrode 411 and the magnetic member 412 are both annular structures or D-shaped structures, and the electrode 411 and the magnetic member 412 are sleeved on the support member 413 .
  • multiple magnetic members 412 there are multiple magnetic members 412 , multiple electrodes 411 and multiple magnetic members 412 are sleeved on the support member 413 , and multiple electrodes 411 and multiple magnetic members 412 are alternately arranged along the extending direction of the support member 413 .
  • the electrode assembly further includes an operation handle 460 and a push-pull part 440, the push-pull part 440 is movably arranged on the operation handle 460;
  • the push-pull member 440 moves relative to the operating handle 460 to pull the electrode tip 410 to bend or straighten the electrode tip 410 .
  • two ends of the fourth pulling wire 424 are respectively connected with the end piece of the electrode tip and the operating handle 460 .
  • the tip piece is located at one end of the electrode tip 410 away from the operating handle 460 .
  • the present disclosure also provides an ablation device, the ablation device includes a first electrode assembly and a second electrode assembly, the first electrode assembly is the electrode assembly corresponding to the embodiment shown in FIGS. 1 to 8 in the foregoing embodiments, and the second electrode assembly
  • the electrode assembly is the electrode assembly corresponding to the embodiment shown in FIG. 9 to FIG. 11 in the foregoing embodiments.
  • the electrode 411 of the first electrode assembly is disposed opposite to the electrode 411 of the second electrode assembly so as to pass through the electrode 411 of the first electrode assembly. and the electrode 411 of the second electrode assembly to ablate the tissue to be ablated between the electrode 411 of the first electrode assembly and the electrode 411 of the second electrode assembly.
  • the ablation device further includes an ablation circuit, and the electrodes 411 of the first electrode assembly and the electrodes 411 of the second electrode assembly are both disposed on the ablation circuit, so as to adjust the two electrodes by testing the impedance between the two opposite electrodes. RF energy between electrodes 411 for ablation.
  • the electrode end of the first electrode assembly is the first electrode end 110 , the electrode of the first electrode assembly is the first electrode 111 , and the magnetic member of the first electrode assembly is the first magnetic member, that is, the first electrode end 110 It includes a first electrode 111 and a first magnetic member; the electrode end of the second electrode assembly is the second electrode end 210, the electrode of the second electrode assembly is the second electrode 112, and the magnetic member of the second electrode assembly is the second magnetic
  • the member 212 that is, the second electrode tip 210 includes the second electrode 112 and the second magnetic member 212 .
  • 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.
  • 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 112 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 112
  • the impedance is used to adjust the radio frequency energy between the first electrode 111 and the second electrode 112 for ablation, and after the impedance reaches a certain resistance value, the machine alarms that the ablation is completed, so as to avoid excessive ablation and 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 112 there are multiple first electrodes 111 and multiple second electrodes 112, and multiple first electrodes 111 and multiple second electrodes 112 are provided in one-to-one correspondence;
  • the second electrodes 112 so that the plurality of first electrodes 111 and the plurality of second electrodes 112 can act on their corresponding tissues at the same time, so as to enhance the ablation effect and improve the ablation efficiency.
  • each pair of electrodes is relatively independent, that is, the number of working electrodes can be controlled.
  • 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 112 are arranged along the extending direction of the first electrode tip 110 .
  • the extending directions of the second electrode terminals 210 are arranged at intervals, and each of the first electrodes 111 and the corresponding second electrodes 112 are arranged in pairs; Corresponding tissue to form a complete ablation line to ensure the ablation effect; and to arrange a plurality of first electrodes 111 at intervals and a plurality of second electrodes 112 at intervals, which can avoid the phase difference between two adjacent first electrodes 111.
  • the two adjacent second electrodes 112 influence each other.
  • the first magnetic member and the second magnetic member 212 are matched so that the first electrode tip 110 and the second electrode tip 210 are relatively fixed, thereby making the first electrode 111 of the first electrode tip 110 relatively fixed. It can be disposed opposite to the corresponding second electrode 112 of the second electrode tip 210 .
  • the multiple first magnetic members are arranged at intervals along the extending direction of the first electrode tip 110
  • the multiple second magnetic members 212 are arranged along the extending direction of the first electrode tip 110 .
  • the extending directions of the second electrode ends 210 are arranged at intervals to ensure the overall fixing effect between the first electrode ends 110 and the second electrode ends 210 .
  • each pair of the first magnetic member 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 member 412 is controllable and adjustable, a small magnetic force is used for initial positioning, and a larger magnetic force is used for final positioning, so that the inner and outer two electrode assemblies are flexible during initial positioning and firm after final positioning, ensuring that The fit of the electrodes ensures the ablation effect.
  • the first magnetic member is an electromagnet; and/or, the second magnetic member 212 is an electromagnet.
  • the shielding side eave 415 by setting the shielding side eave 415, the tissue fluid outside the ablation line and liquids such as physiological saline can be shielded from entering the ablation tissue, so as to avoid the measurement accuracy of the resistance value between the first electrode 111 and the second electrode 112 during ablation, thereby affecting the ablation effect.
  • 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 112 forming the mapping electrode pair are different, Across voltages are set to form currents for mapping.
  • the polarities of the first electrodes 111 and the second electrodes 112 that form the mapping electrode pair are different, and the cross-voltage is set to form a current, thereby realizing mapping; the polarities of the two second electrodes 112 that form the mapping electrode pair are different, and the The voltage is set to form the current, which in turn enables the mapping.
  • 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 impedance and/or radio frequency power of the tissue to be ablated between two opposite electrodes.
  • the radio frequency host 310 is further provided with an ablation interface 311, the first electrode assembly and the second electrode assembly include a plurality of lead assemblies, each lead assembly includes a lead connector and a plurality of parallel wires connected to the lead connector , each lead 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 first ablation interface parts for inserting a plurality of lead wires of the first electrode assembly.
  • the second ablation interface part has a plurality of second ablation interfaces for inserting a plurality of lead wires of the second electrode assembly, so as to connect to the corresponding first electrode through each first ablation interface and each second ablation interface 111 and the corresponding second electrode 112 provide suitable radio frequency power.
  • the radio frequency host 310 is further provided with an electromagnetic interface 312, and both the first electrode assembly and the second electrode assembly include a plurality of electromagnet assemblies , each electromagnet assembly includes an electromagnetic joint and a plurality of parallel-arranged electromagnetic wires connected 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, and the second electromagnetic interface part has a plurality of first magnetic interfaces for inserting a plurality of electromagnetic joints of the second electrode assembly.
  • Two magnetic interfaces so as to supply power to the corresponding first magnetic member and the corresponding second magnetic member 212 through each of the first magnetic interface and each of the second magnetic interfaces, so as to make the corresponding first magnetic member and the corresponding second magnetic member 212 attraction between them.
  • the radio frequency host 310 is provided with an electromagnetic interface 312, the first magnetic member of the first electrode assembly of the ablation device and the second magnetic member 212 of the second electrode assembly are both electromagnetic
  • the two magnetic pieces 212 include a plurality of wire assemblies, each wire assembly includes a wire joint and a plurality of parallel wires connected to the wire joint, and each wire is used to connect with the corresponding magnetic piece;
  • the electromagnetic interface 312 has a first electromagnetic interface part and The second electromagnetic interface part, the first electromagnetic interface part has a plurality of first electromagnetic interfaces for inserting a plurality of wire connectors of the first magnetic part, and the interface part of the second magnetic part 212 has a plurality of first electromagnetic interfaces for the second electromagnetic assembly a plurality of second electromagnetic interfaces into which the wire connectors are inserted
  • the first electrode assembly and the second electrode assembly of the ablation device work independently of each other to perform the treatment on the tissue to be ablated 340 in contact with the first electrode assembly and the tissue to be ablated 340 in contact with the second electrode assembly, respectively.
  • ablation The energization circuits of the two adjacent first electrodes or the second electrodes are independently arranged to form an ablation electrode pair, so as to realize the ablation function.
  • the first electrode tip 110 , the second electrode tip 210 , the second electrode 211 , the second magnetic member 212 , the first electrode 111 , the second electrode 112 and the ablation circuit 320 of the ablation device As shown in FIGS. 14 to 21 , the first electrode tip 110 , the second electrode tip 210 , the second electrode 211 , the second magnetic member 212 , the first electrode 111 , the second electrode 112 and the ablation circuit 320 of the ablation device .
  • 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 electrode assembly includes an electrode tip 410 and a pulling wire assembly 420.
  • the electrode tip 410 includes a support member 413 and a plurality of electrodes 411 arranged on the support member 413.
  • the electrodes 411 are arranged at intervals along the extending direction of the support member 413; that is, multiple electrodes 411 simultaneously act on the corresponding endocardial or epicardial tissue to be ablated to form a complete ablation line to ensure the ablation effect and improve the
  • multiple electrodes 411 are arranged at intervals to avoid mutual influence between two adjacent electrodes 411; Straight state, so that the electrode tip 410 can form a good fit effect with the tissue to be ablated, solve the problem of limited angle of the current ablation device products, and then ensure that each electrode 411 can better act on the corresponding tissue to be ablated , to ensure the ablation effect; it can be seen that the use of the electrode assembly can solve the problem of unsatisfactory ablation effect of the medical interventional ablation
  • electrode assemblies can be placed on the endocardium and the epicardium at the same time, and the electrodes are arranged opposite to each other, so as to ablate the tissue to be ablated between the electrodes through the electrodes of different electrode assemblies.
  • the first electrode assembly is placed on the epicardium and the second electrode assembly is placed on the endocardium, so that the first electrode assembly and the second electrode assembly act on the epicardium and the endocardium respectively, so as to realize the simultaneous ablation of the epicardium. and endocardium, solve the problem of dynamic ablation in cardiac surgery, but the surgical ablation is more traumatic and the recovery is slow after surgery.
  • a single electrode assembly or a working electrode assembly can perform timely mapping to monitor the ablation effect. And it is the problem of point-like mapping, which improves the effect of surgical ablation.
  • the electrode assembly includes an electrode tip 410 and a pulling wire assembly 420 , the electrode tip 410 includes a support member 413 and a plurality of electrodes 411 disposed on the support member 413
  • the support member 413 is strip-shaped, and a plurality of electrodes 411 are arranged at intervals along the extension direction of the support member 413;
  • the ablation device in some embodiments ablation principle of the tissue 340 to be ablated, and the ablation range 330 of the ablation device can be embodied.
  • the electrode assembly includes an electrode tip 410 and a pulling wire assembly 420.
  • the electrode tip 410 includes a support member 413 and a plurality of electrodes 411 arranged on the support member 413.
  • the electrodes 411 are arranged at intervals along the extending direction of the support 413; that is, a plurality of electrodes 411 act on the corresponding parts to be ablated at the same time to form a complete ablation line to ensure the ablation effect and improve the ablation efficiency.
  • the pull wire assembly 420 is connected to the electrode end 410, so that the electrode end 410 is driven to bend or straighten by the pull wire assembly 420, so that the electrode end 410 can form a good fit effect with the part to be ablated, thereby ensuring that each electrode 411 can better act on the corresponding part to be ablated to ensure the ablation effect; it can be seen that the use of this electrode assembly can solve the problems in the prior art.
  • the ablation effect of the ablation device is not ideal.
  • the support member 413 is tubular, and the pull wire assembly 420 is inserted into the lumen of the support member 413 , so that when the pull wire assembly 420 is pulled, the support member 413 is bent or in a straight state, so that the support member 413 A good fit effect can be formed with the part to be ablated, so that each electrode 411 can better act on the corresponding part to be ablated.
  • the electrode tip 410 further includes a magnetic member 412 , and the magnetic member 412 is disposed in the lumen of the support member 413 or sleeved on the support member 413 ; wherein the pull wire assembly 420 is connected to the magnetic member 412 .
  • the plurality of electrodes 411 are distributed along the extending direction of the support member 413 .
  • the pulling wire assembly 420 includes a plurality of pulling wires, and the plurality of pulling wires are arranged at intervals; each pulling wire is connected with one end of the electrode tip 410, so as to pull the electrode tip 410 to bend or be in a pulling position through the cooperation between the plurality of pulling wires straight state. That is, each pull wire is connected to the magnetic member 412 located at one end of the electrode tip 410 .
  • a plurality of pulling wires are arranged at intervals along the extending direction perpendicular to the electrode tip 410 .
  • the electrode assembly provided in some embodiments is the electrode assembly shown in FIGS. 1 to 8 .
  • the support 413 is a tubular body.
  • the pulling wire assembly 420 includes a first pulling wire 421, a second pulling wire 422 and a third pulling wire 423.
  • the first pulling wire 421, the second pulling wire 422 and the third pulling wire 423 are all connected to one end of the electrode terminal 410; Both the second pull wire 422 and the third pull wire 423 are connected to one end of the electrode terminal 410 .
  • the second pulling wire 422 is located between the first pulling wire 421 and the third pulling wire 423 , and the center line of the second pulling wire 422 is coincident with the center line of the support member 413 , so that when the second pulling wire 422 is pulled, the electrode tip 410 is straightened At this time, neither the first pull wire 421 nor the third pull wire 423 can be pulled.
  • the first pulling wire 421 and the third pulling wire 423 are located on two sides of the center line of the support member 413 respectively, so that when the first pulling wire 421 and the third pulling wire 423 are pulled, respectively, the electrode tip 410 is bent in opposite directions.
  • a plurality of electrodes 411 and a magnetic member 412 are disposed in the lumen of the support member 413 , and the magnetic member 412 is used to position the electrode tip 410 .
  • the electrode 411 and/or the magnetic member 412 are provided with a first avoidance opening 431 , a second avoidance opening 432 and a third avoidance opening 433 which are arranged at intervals in sequence, and the first pull wire 421 passes through the It is arranged in the first avoidance opening 431 , the second pull wire 422 is passed through the second avoidance opening 432 , and the third pull wire 423 is passed through the third avoidance opening 433 .
  • each electrode 411 When there are a plurality of electrodes 411 , each electrode 411 is provided with a first avoidance opening 431 , a second avoidance opening 432 and a third avoidance opening 433 which are arranged at intervals in sequence; when there are multiple magnetic members 412 , each of the magnetic members 412 is A first avoidance opening 431 , a second avoidance opening 432 and a third avoidance opening 433 are provided in sequence and spaced apart.
  • the first pull wires 421 are sequentially passed through the first avoidance openings 431 of the plurality of electrodes 411 and/or the first avoidance openings 431 of the plurality of magnetic members 412 ; the second pull wires 422 are successively passed through the second avoidance openings of the plurality of electrodes 411 .
  • the openings 432 and/or the second avoidance openings 432 of the plurality of magnetic members 412; the third pull wires 423 are sequentially passed through the third avoidance openings 433 of the plurality of electrodes 411 and/or the third avoidance openings 433 of the plurality of magnetic members 412 Inside.
  • the first avoidance opening 431, the second avoidance opening 432 and the third avoidance opening 433 are all cylindrical holes; or, the second avoidance opening 432 is a cylindrical hole, and the first avoidance opening 431 and the third avoidance opening 433 are both. groove structure.
  • the electrode assembly further includes an operation handle 460, which is connected to the electrode end 410.
  • the operation handle 460 is provided with a first direction control button 461 and a second direction control button 462, and the first direction control button 461 is connected with the first direction control button 461.
  • a pull wire 421 and a third pull wire 423 are both connected to pull the first pull wire 421 and the third pull wire 423 by pushing the first direction control button 461;
  • the second direction control button 462 is connected to the second pull wire 422 to control the second pull wire by pushing the second direction
  • the button 462 pulls the second pull wire 422 .
  • the two ends of the first pull wire 421 are respectively connected to the first direction control button 461 and one end of the electrode terminal 410
  • the two ends of the third pull wire 423 are respectively connected to the first direction control button 461 and one end of the electrode terminal 410
  • Two ends of the two pull wires 422 are respectively connected to the second direction control button 462 and one end of the electrode terminal 410 .
  • the first direction control button 461 includes a first operation part and a second operation part, the first operation part is connected with the first pull wire 421, and the second operation part is connected with the third pull wire 423, so as to push the first pull wire 423 respectively.
  • An operation part and a second operation part pull the first pull wire 421 and the third pull wire 423 .
  • each magnetic member 412 is used to separate the corresponding of the two electrodes 411.
  • the magnetic member 412 located at one end of the electrode tip 410 away from the operating handle 460 is used for connecting with the first pulling wire 421 , the second pulling wire 422 and the third pulling wire 423 .
  • two opposite sides of the support member 413 are provided with shielding side eaves 415 , so as to form a shielding protection effect on the plurality of electrodes 411 and the plurality of magnetic members 412 inside the support member 413 . , so as to prevent blood and the like of the epicardial tissue from entering into the area between the support member 413 and the epicardium during the ablation process, thereby affecting the tightness between the support member 413 and the epicardium.
  • the blocking side eaves 415 are strip-shaped, and the blocking side eaves 415 extend along the extending direction of the support member 413 .
  • the electrode assembly further includes a suction positioning member 417 , and the suction positioning member 417 is disposed on the support member 413 , so that the support member 413 is positioned at the site to be ablated by the suction positioning member 417 .
  • the suction positioning members 417 are arranged in pairs, and each pair of suction positioning members 417 works relatively independently during operation, that is, the number of suction positioning members to work can be determined according to actual needs.
  • the suction positioning member 417 is a suction cup structure.
  • the suction positioning member 417 includes a suction inner wall 4171 and a suction outer wall 4172, and a suction cavity 4173 is formed between the suction inner wall 4171 and the suction outer wall 4172, and a suction cavity 4173 is formed between the suction inner wall 4171 and the suction outer wall 4172.
  • the first suction port 4174 and the second suction port 4175 communicate with the suction cavity 4173 , and the orientation of the first suction port 4174 and the second suction port 4175 is the same.
  • Both the suction inner wall 4171 and the suction inner wall 4171 are U-shaped structures, and the suction inner wall 4171 and the suction outer wall 4172 are arranged around the support member 413 .
  • the suction positioning member 417 further includes an air flow channel 4176 , and the air outlet end of the air flow channel 4176 is communicated with the suction cavity 4173 , so as to fill and draw air into the suction cavity 4173 through the air flow channel 4176 .
  • pull-in positioning members 417 there are multiple pull-in positioning members 417 .
  • an arrangement of the plurality of suction positioning members 417 is: the plurality of suction positioning members 417 are arranged at intervals along the extending direction of the support member 413, so that the support member 413 is stably positioned on the site to be ablated , to ensure the positioning effect of the support member 413 .
  • another arrangement of the multiple suction positioning members 417 is: as shown in FIG. 3 , the multiple suction positioning members 417 are arranged in pairs, and the paired two suction positioning members 417 are respectively They are arranged on opposite sides of the support member 413 to ensure a good fit between both sides of the support member 413 and the tissue to be ablated, so that the corresponding electrodes 411 can better act on the corresponding ablated tissue. tissue to ensure the ablation effect.
  • a plurality of pairs of suction positioning members 417 are arranged at intervals along the extending direction of the support member 413, so that the support member 413 can be stably positioned on the site to be ablated, so as to ensure the positioning effect of the support member 413, thereby ensuring the gap between the support member 413 and the tissue to be ablated. Therefore, each electrode 411 can better act on its corresponding tissue to be ablated, so as to ensure the ablation effect.
  • the electrode assembly further includes an extrusion positioning member 414 , at least a part of the extrusion positioning member 414 is located outside the support member 413 , and at least a part of the extrusion positioning member 414 can be It is configured to expand and contract, so as to squeeze the support member 413 on the site to be ablated when the squeeze positioning member 414 expands.
  • the extrusion positioning member 414 is an airbag structure.
  • the multiple extrusion positioning members 414 are arranged at intervals along the extending direction of the support member 413, so that the multiple extrusion positioning members 414 all form a extrusion effect on the support member 413, so as to
  • the support member 413 has a good fit with the site to be ablated, thereby ensuring the fit effect of the support member 413 and the site to be ablated.
  • an arrangement of the pressing and positioning member 414 is as follows: as shown in FIG. 5 , an accommodating groove is provided on the outer wall of the supporting member 413 .
  • an accommodating groove is provided on the outer wall of the supporting member 413 .
  • the airbag structure is accommodated in the accommodating groove.
  • the airbag structure is in the expanded state, at least part of the airbag structure is released from the accommodating groove to form a pressing effect on the support member 413 .
  • a plurality of accommodating grooves are provided on the outer wall of the supporting member 413 , and the plurality of accommodating grooves are arranged at intervals along the extending direction of the supporting member 413 .
  • another arrangement of the extrusion positioning member 414 is as follows: the sheath wall of the support member 413 is provided with an escape hole, and when the airbag structure is in a contracted state, the airbag structure is accommodated in the cavity of the support member 413; When the airbag structure is in the inflated state, at least part of the airbag structure protrudes to the outside of the support member 413 through the escape hole to form a pressing effect on the support member 413 .
  • a positioning groove for accommodating the airbag structure is provided on the electrode 411 and/or the magnetic member 412 .
  • the electrode assembly further includes a filler 416 , the filler 416 is disposed in the cavity of the support 413 , and at least a part of the filler 416 is configured to be expandable and contractible, so as to orient the electrode 411 toward the filler 416 when the filler 416 expands.
  • the site to be ablated is squeezed.
  • the electrode 411 is squeezed by the filler 416 to move the electrode 411 toward the part to be ablated, so that the electrode 411 can fit with the inner wall of the support member 413, and the outer wall of the support member 413 at the corresponding position is
  • the corresponding parts to be ablated are adhered to ensure that the electrodes 411 can better act on the corresponding parts to be ablated, and the ablation effect is ensured.
  • a structural form of the filler 416 is as follows: as shown in FIG. 7 , the filler 416 is strip-shaped, and the filler 416 extends along the extension direction of the support 413 .
  • the filler 416 is a balloon structure, so as to form a squeezing effect on the plurality of electrodes 411 when the balloon structure is inflated and expanded.
  • another structural form of the packing member 416 is: there are multiple packing members 416, and the multiple packing members 416 are arranged at intervals along the extending direction of the support member 413; the multiple packing members 416 and the multiple electrodes 411 are one Each filling piece 416 is arranged in a corresponding manner, so that each filling piece 416 can form a pressing effect on the corresponding electrode 411; each filling piece 416 is arranged on the side of the corresponding electrode 411 away from the part to be ablated, so that each filling piece 416 can compress the corresponding electrode 411. When the electrodes 411 of the electrodes 411 form a pressing effect, each electrode 411 moves in a direction close to the corresponding part to be ablated.
  • each filling member 416 is an airbag structure, so that when the airbag structure is inflated and inflated, the corresponding electrode 411 is squeezed.
  • the support member 413 is provided with a first opening opening for avoiding the electrode 411 , and a part of the structure of the electrode 411 protrudes from the first opening opening to the outside of the support member 413 , and protrudes from the support member 413
  • This part of the electrode structure on the outside can be in contact with the corresponding part to be ablated, so that this part of the electrode structure directly acts on the corresponding part to be ablated, and at the same time, the electrode structure located in the support 413 also acts on the corresponding part to be ablated, and then It is ensured that the electrode 411 can better act on the corresponding part to be ablated, so as to ensure the ablation effect and improve the ablation efficiency.
  • the supporting member 413 is also provided with a second opening for avoiding the magnetic member 412.
  • Part of the structure of the magnetic member 412 protrudes from the second opening to the outside of the supporting member 413.
  • Part of the magnetic parts 412 can be in direct contact with the parts to be fixed, and at the same time, the magnetic parts 412 located in the support parts 413 also cooperate with the parts to be fixed, so that the positioning effect between the support parts 413 and the parts to be fixed is more stable, which helps In order to make the electrode 411 perform ablation stably to ensure the ablation effect.
  • the electrode 411 and/or the magnetic member 412 are provided with a wire laying groove 450 for accommodating the wire 418 , and the wire 418 is used for connecting with the electrode 411 ; or, A wire laying groove 450 for laying the wire 418 is provided on the inner wall of the support member 413 .
  • the electrode assembly provided in some embodiments is the electrode assembly shown in FIGS. 9 to 11 .
  • the puller wire assembly 420 includes a fourth puller wire 424, the fourth puller wire 424 is disposed in the lumen of the support member 413, and the centerline of the fourth puller wire 424 is spaced apart from the centerline of the support member 413, so that the fourth puller wire 424 can be pulled When the four wires 424 are pulled, the electrode tip 410 is bent or in a straightened state.
  • the electrode 411 and the magnetic member 412 are both annular structures, and the electrode 411 and the magnetic member 412 are sleeved on the support member 413 .
  • multiple magnetic members 412 there are multiple magnetic members 412 , multiple electrodes 411 and multiple magnetic members 412 are sleeved on the support member 413 , and multiple electrodes 411 and multiple magnetic members 412 are alternately arranged along the extending direction of the support member 413 .
  • the electrode assembly further includes an operation handle 460 and a push-pull part 440, the push-pull part 440 is movably arranged on the operation handle 460;
  • the push-pull member 440 moves relative to the operating handle 460 to pull the electrode tip 410 to bend or straighten the electrode tip 410 .
  • two ends of the fourth pulling wire 424 are respectively connected with the end piece of the electrode tip and the operating handle 460 .
  • the tip piece is located at one end of the electrode tip 410 away from the operating handle 460 .
  • the present disclosure also provides an ablation device, the ablation device includes a first electrode assembly and a second electrode assembly, the first electrode assembly is the electrode assembly corresponding to the embodiment shown in FIGS. 1 to 8 , and the second electrode assembly is the electrode assembly shown in FIGS.
  • the electrode 411 of the first electrode assembly is disposed opposite to the electrode 411 of the second electrode assembly, so that the electrode 411 of the first electrode assembly and the electrode 411 of the second electrode assembly are positioned opposite to the first electrode assembly.
  • the site to be ablated between the electrode 411 of the electrode assembly and the electrode 411 of the second electrode assembly is ablated.
  • the ablation device further includes an ablation circuit 320, and the electrodes 411 of the first electrode assembly and the electrodes 411 of the second electrode assembly are both disposed on the ablation circuit 320, so as to adjust the impedance between the two opposite electrodes by testing Radiofrequency energy between the two electrodes 411 for ablation.
  • the electrode end of the first electrode assembly is the first electrode end, the electrode of the first electrode assembly is the first electrode, and the magnetic member of the first electrode assembly is the first magnetic member, that is, the first electrode end includes the first electrode.
  • the electrode and the first magnetic member; the electrode end of the second electrode assembly is the second electrode end, the electrode of the second electrode assembly is the second electrode, and the magnetic member of the second electrode assembly is the second magnetic member, that is, the second electric
  • the pole tip includes a second electrode and a second magnetic member.
  • 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.
  • 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 and the second electrode can be tested in real time, and the first electrode can be adjusted according to the impedance between the first electrode and the second electrode detected in real time
  • the ablation is performed by the radio frequency energy between the second electrode and the second electrode, and the machine will alarm when the impedance reaches a certain resistance value, and the ablation is completed to avoid excessive ablation. It also solves the problem of complete dehydration and degeneration of the external body, 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 and multiple second electrodes there are multiple first electrodes and multiple second electrodes, and multiple first electrodes and multiple second electrodes are provided in one-to-one correspondence; by setting multiple first electrodes and multiple second electrodes, the The multiple first electrodes and the multiple second electrodes can act on their corresponding tissues at the same time, so as to enhance the ablation effect and improve the ablation efficiency.
  • each pair of electrodes is relatively independent, that is, the number of working electrodes can be controlled.
  • the first electrode tip and the second electrode tip are both strip-shaped, a plurality of first electrodes are arranged at intervals along the extending direction of the first electrode tip, and a plurality of second electrodes are arranged along the second electrode tip
  • the extension directions of the electrodes are arranged at intervals, and each first electrode and its corresponding second electrode are arranged in pairs; that is, a plurality of first electrodes and a plurality of second electrodes simultaneously act on the corresponding tissue to form a complete ablation
  • the line can ensure the ablation effect; and the plurality of first electrodes are arranged at intervals and the plurality of second electrodes are arranged at intervals, which can avoid mutual influence between two adjacent first electrodes and between adjacent two second electrodes.
  • the first magnetic member and the second magnetic member are matched, so that the first electrode end and the second electrode end are relatively fixed, so that the first electrode of the first electrode end can be connected with the second electrode end.
  • the corresponding second electrodes of the extreme heads are arranged opposite.
  • the plurality of first magnetic members are arranged at intervals along the extending direction of the first electrode tip, and the plurality of second magnetic members are arranged along the extending direction of the first electrode tip.
  • the extension directions of the electrode tips are arranged at intervals to ensure the overall fixing effect between the first electrode tip and the second electrode tip.
  • each pair of the first magnetic member and the second magnetic member 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 member 412 is controllable and adjustable, a small magnetic force is used for initial positioning, and a larger magnetic force is used for final positioning, so that the inner and outer two electrode assemblies are flexible during initial positioning and firm after final positioning, ensuring that The fit of the electrodes ensures the ablation effect.
  • the first magnetic member is an electromagnet; and/or the second magnetic member is an electromagnet.
  • 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.
  • the present disclosure also provides a radio frequency ablation device, as shown in FIG. 13 , 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 impedance and/or radio frequency power of the tissue to be ablated between two opposite electrodes.
  • the radio frequency host 310 is further provided with an ablation interface 311, the first electrode assembly and the second electrode assembly include a plurality of lead assemblies, each lead assembly includes a lead connector and a plurality of parallel wires connected to the lead connector , each lead 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 first ablation interface parts for inserting a plurality of lead wires of the first electrode assembly.
  • the second ablation interface part has a plurality of second ablation interfaces for inserting a plurality of lead wires of the second electrode assembly, so as to connect to the corresponding first electrode through each first ablation interface and each second ablation interface and corresponding second electrodes to provide suitable radio frequency power.
  • the radio frequency host 310 is further provided with an electromagnetic interface 312, and both the first electrode assembly and the second electrode assembly include a plurality of electromagnet assemblies, Each electromagnet assembly includes an electromagnetic joint and a plurality of parallel-arranged electromagnetic wires connected to the electromagnetic joint, and each electromagnetic wire is used to connect with a corresponding electromagnet;
  • the electromagnetic interface 312 has a first electromagnetic interface part and a second electromagnetic interface part, the first electromagnetic interface part is An electromagnetic interface portion has a plurality of first magnetic interfaces for insertion of a plurality of electromagnetic joints of the first electrode assembly, and a second electromagnetic interface portion has a plurality of second magnetic joints for insertion of a plurality of electromagnetic joints of the second electrode assembly
  • the magnetic interface is used to supply power to the corresponding first magnetic member and the corresponding second magnetic member through each of the first magnetic interface and each of the second magnetic interfaces, so as to generate electricity between the corresponding first magnetic member and the corresponding second magnetic member suction force.
  • the first electrode tip 110 , the second electrode tip 210 , the second electrode 211 , the second magnetic member 212 , the first electrode 111 , the second electrode 112 and the ablation circuit 320 of the ablation device As shown in FIGS. 14 to 21 , the first electrode tip 110 , the second electrode tip 210 , the second electrode 211 , the second magnetic member 212 , the first electrode 111 , the second electrode 112 and the ablation circuit 320 of the ablation device .
  • 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 electrode assembly includes an electrode tip 410 and a pulling wire assembly 420.
  • the electrode tip 410 includes a support member 413 and a plurality of electrodes 411 arranged on the support member 413.
  • the electrodes 411 are arranged at intervals along the extending direction of the support member 413; that is, multiple electrodes 411 simultaneously act on the corresponding endocardial or epicardial tissue to be ablated to form a complete ablation line to ensure the ablation effect and improve the
  • multiple electrodes 411 are arranged at intervals to avoid mutual influence between two adjacent electrodes 411; Straight state, so that the electrode tip 410 can form a good fit effect with the tissue to be ablated, solve the problem of limited angle of the current ablation device products, and then ensure that each electrode 411 can better act on the corresponding tissue to be ablated , to ensure the ablation effect; it can be seen that the use of the electrode assembly can solve the problem of unsatisfactory ablation effect of the medical interventional ablation
  • electrode assemblies can be placed on the endocardium and the epicardium at the same time, and the electrodes are arranged opposite to each other, so as to ablate the tissue to be ablated between the electrodes through the electrodes of different electrode assemblies.
  • the first electrode assembly is placed on the epicardium and the second electrode assembly is placed on the endocardium, so that the first electrode assembly and the second electrode assembly act on the epicardium and the endocardium respectively, so as to realize the simultaneous ablation of the epicardium. and endocardium, solve the problem of dynamic ablation in cardiac surgery, but the surgical ablation is more traumatic and the recovery is slow after surgery.
  • a single electrode assembly or a working electrode assembly can perform timely mapping to monitor the ablation effect. And it is the problem of point-like mapping, which improves the effect of surgical ablation.
  • 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.

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Abstract

L'invention concerne un ensemble électrode, un dispositif d'ablation et un appareil d'ablation par radiofréquence. L'ensemble électrode comprend une pointe d'électrode (410) et un ensemble fil de traction (420), la pointe d'électrode (410) comprend un élément de support (413) et une pluralité d'électrodes (411) disposées sur l'élément de support (413) ; l'élément de support (413) est en forme de bande ; la pluralité d'électrodes (411) sont agencées à des intervalles dans une direction d'extension de l'élément de support (413) ; et l'ensemble fil de traction (420) est relié à la pointe d'électrode (410) de manière à courber ou à redresser la pointe d'électrode (410) en tirant l'ensemble de fil de traction (420), de telle sorte que la pointe d'électrode (410) est bien ajustée avec un tissu à ablater, ce qui permet d'assurer que chacune des électrodes (411) peut mieux agir sur un tissu correspondant à ablater de façon à garantir un effet d'ablation. L'ensemble électrode peut être utilisé pour résoudre le problème de l'effet d'ablation d'un dispositif d'ablation dans l'état de la technique n'étant pas satisfaisant.
PCT/CN2021/132340 2021-01-08 2021-11-23 Ensemble électrode, dispositif d'ablation et appareil d'ablation par radiofréquence Ceased WO2022148153A1 (fr)

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CN202110026529.0 2021-01-08
CN202120048218.X 2021-01-08
CN202120048218.XU CN215349405U (zh) 2021-01-08 2021-01-08 电极组件、消融装置和射频消融设备
CN202110026529.0A CN114748152A (zh) 2021-01-08 2021-01-08 电极组件、消融装置和射频消融设备

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1200916A (zh) * 1997-05-29 1998-12-09 郭伟 滑动式吸附电极导管
US6237605B1 (en) * 1996-10-22 2001-05-29 Epicor, Inc. Methods of epicardial ablation
US20030208195A1 (en) * 2002-05-03 2003-11-06 Scimed Life Systems, Inc. Ablation systems including insulated energy transmitting elements
US20120172872A1 (en) * 2010-12-23 2012-07-05 Georg Nollert Pair of endocardial and epicardial catheters, catheter and method for positioning electrodes on a cardiac wall and method for the ablation of cardiac muscle tissue
CN105395249A (zh) * 2015-12-03 2016-03-16 上海慧达医疗器械有限公司 肾动脉交感神经消融灌注管、其应用导管及消融系统
CN105982733A (zh) * 2015-02-27 2016-10-05 四川锦江电子科技有限公司 一种可控多电极消融装置

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6237605B1 (en) * 1996-10-22 2001-05-29 Epicor, Inc. Methods of epicardial ablation
CN1200916A (zh) * 1997-05-29 1998-12-09 郭伟 滑动式吸附电极导管
US20030208195A1 (en) * 2002-05-03 2003-11-06 Scimed Life Systems, Inc. Ablation systems including insulated energy transmitting elements
US20120172872A1 (en) * 2010-12-23 2012-07-05 Georg Nollert Pair of endocardial and epicardial catheters, catheter and method for positioning electrodes on a cardiac wall and method for the ablation of cardiac muscle tissue
CN105982733A (zh) * 2015-02-27 2016-10-05 四川锦江电子科技有限公司 一种可控多电极消融装置
CN105395249A (zh) * 2015-12-03 2016-03-16 上海慧达医疗器械有限公司 肾动脉交感神经消融灌注管、其应用导管及消融系统

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