WO2016124138A1 - 一种螺旋结构的射频消融导管及其设备 - Google Patents

一种螺旋结构的射频消融导管及其设备 Download PDF

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Publication number
WO2016124138A1
WO2016124138A1 PCT/CN2016/073378 CN2016073378W WO2016124138A1 WO 2016124138 A1 WO2016124138 A1 WO 2016124138A1 CN 2016073378 W CN2016073378 W CN 2016073378W WO 2016124138 A1 WO2016124138 A1 WO 2016124138A1
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WIPO (PCT)
Prior art keywords
electrode holder
wire
ablation catheter
catheter
radiofrequency ablation
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.)
Ceased
Application number
PCT/CN2016/073378
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English (en)
French (fr)
Chinese (zh)
Inventor
董永华
沈美君
吉亮
姜君
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.)
Shanghai Golden Leaf Med Tec Co Ltd
Original Assignee
Shanghai Golden Leaf Med Tec 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 CN201510057095.5A external-priority patent/CN104605930A/zh
Priority claimed from CN201510129947.7A external-priority patent/CN104688334A/zh
Priority claimed from CN201520434410.7U external-priority patent/CN204971568U/zh
Application filed by Shanghai Golden Leaf Med Tec Co Ltd filed Critical Shanghai Golden Leaf Med Tec Co Ltd
Priority to ES16746133T priority Critical patent/ES2955930T3/es
Priority to US15/548,672 priority patent/US10646272B2/en
Priority to EP18162451.1A priority patent/EP3360497B1/en
Priority to JP2017558612A priority patent/JP6716607B2/ja
Priority to EP16746133.4A priority patent/EP3254635B1/en
Publication of WO2016124138A1 publication Critical patent/WO2016124138A1/zh
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
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00184—Moving parts
    • A61B2018/00196—Moving parts reciprocating lengthwise
    • 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
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • 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
    • A61B2018/0091—Handpieces of the surgical instrument or device
    • A61B2018/00916—Handpieces of the surgical instrument or device with means for switching or controlling the main function of the instrument or device
    • A61B2018/0094—Types of switches or controllers
    • 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
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1435—Spiral
    • 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
    • A61B2018/1465—Deformable electrodes
    • 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
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • 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
    • A61B2018/1475—Electrodes retractable in or deployable from a housing

Definitions

  • the invention relates to a spiral structure radiofrequency ablation catheter, and relates to a radio frequency ablation device including the above radio frequency ablation catheter, and belongs to the technical field of interventional medical devices.
  • radiofrequency ablation catheters are key components for intervention in human blood vessels and RF energy release.
  • the RF electrode is mounted on a bracket at the front end of the RF ablation catheter.
  • the bracket is used to carry the RF electrode and expands the wall before the RF starts. Since the radiofrequency ablation procedure is performed directly in the blood vessels of the human body, the telescopic size of the stent is adapted to the diameter of the human blood vessel.
  • the diameter of the blood vessels in the human body varies depending on the ablation site.
  • the diameter of human blood vessels varies from person to person.
  • the diameter of the renal artery is about 2 to 12 mm, which is quite different.
  • the telescopic size of the electrode end of the radiofrequency ablation catheter is generally fixed, and cannot meet the diameter size requirements of different human blood vessels, and the coverage of human blood vessels of different diameters is narrow. Therefore, when performing radiofrequency ablation procedures on different patients, it is usually necessary to replace the radiofrequency ablation catheters of different specifications and models for ablation. Even so, in some cases, there is a problem that the RF electrode cannot be attached at the same time during surgery, which affects the surgical effect.
  • the structure of the radiofrequency ablation catheter is divided into various types according to the shape of the electrode and the electrode holder, for example, a balloon type, a puncture needle type, a spiral type, and a petal structure.
  • the electrode holder is designed to be a spiral type of radio frequency ablation catheter which is widely used.
  • the existing spiral type radio frequency ablation catheter is mainly pre-shaped by the electrode holder, and then guided in the guiding catheter/sheath tube (for example, the sheath tube disclosed in Chinese Utility Model Patent ZL200920172984.6 and the Chinese invention application CN201210480777.3) With the aid of a catheter), the radiofrequency ablation catheter is removed from the sheath/guide catheter by forwarding the radiofrequency ablation catheter or by moving the catheter/sheath, so that the electrode stent recovers after entering the target position. To the shape of the shape. Since the electrode holder is pre-set in size for a single radiofrequency ablation catheter, the existing helical RF ablation catheter has limitations for adaptability to blood vessels of different diameters.
  • the primary technical problem to be solved by the present invention is to provide an improved helical structure radiofrequency ablation catheter.
  • Another technical problem to be solved by the present invention is to provide a radio frequency ablation device including the above radio frequency ablation catheter.
  • a spiral structure radiofrequency ablation catheter having an elongated catheter tube body, a spiral electrode holder is disposed at a front end of the catheter tube body, and the electrode holder is provided with a plurality of electrodes on the catheter tube
  • the rear end of the body is provided with a control handle;
  • One of the lumens of the electrode holder and the catheter body is provided with a slidable supporting anchoring wire, and the supporting adhering wire is divided into a flexible section away from the control handle and a rigid section adjacent to the control handle.
  • the head end of the supporting anchoring wire is restricted to the outside of the electrode holder after passing through the electrode holder, and is movable relative to the distal end of the electrode holder in a direction away from the catheter;
  • a tail end of the support anchoring wire passes through the catheter tube and is fixed to the control handle, and the control handle is used to control the support of the adhering wire to move back and forth.
  • the electrode holder is under the action of the rigid segment supporting the adjusting wire
  • the diameter of the spiral is reduced, the length becomes longer, and it tends to be linear;
  • the electrode holder returns to a spiral shape when the support adhering wire is retracted into the flexible section in the electrode holder.
  • control handle is provided with a button moving member fixed to the tail end of the supporting wall adjusting wire, and the support sticking wall adjustment is controlled by changing the position of the button moving member on the control handle.
  • Silk moves.
  • the head end of the supporting adhering wire is provided with a developing head.
  • the supporting anchoring wire has a bifurcated adjusting wire extending backward, the head end of the bifurcated adjusting wire being fixed at the head end of the supporting adhering wire, or the bifurcation adjustment a head end of the wire is fixed to a certain portion of the flexible section, or the branching regulating wire is a filament which is branched outward from the flexible section, and a rear end of the branching regulating wire is disposed from the a hole in the outer tube of the electrode holder is passed out and is disposed from the electrode holder or the catheter The hole in the tube penetrates and then extends along the lumen of the inner wall of the catheter tube to the outside of the tube and extends into the interior of the control handle and is fixed to the second control member.
  • the electrode holder comprises an outer tube, a plurality of electrodes are embedded on the outer circumference of the outer tube, and a plurality of lumens are arranged inside the outer tube, wherein some of the tubes are respectively arranged There is a set of thermocouple wires and radio frequency wires; each of the electrodes is internally provided with a set of radio frequency wires and thermocouple wires, the radio frequency wires being connected to the electrodes, the thermocouple wires being insulated from the electrodes.
  • the electrode holder is internally provided with a spiral shaped wire.
  • a spiral structure radiofrequency ablation catheter having an elongated catheter tube body, a spiral electrode holder is disposed at a front end of the catheter tube body, and the electrode holder is provided with one or more electrodes, a control handle is disposed at a rear end of the catheter body;
  • a rear section of the adhering wire is slidably disposed in one of the lumens of the catheter body, and a rear end thereof is coupled to a control member disposed on the control handle or passes through the control
  • the handle is then connected to the control member of the peripheral device; after the front portion of the adhering wire passes out of the electrode holder, it is exposed to the outside of the electrode holder, and the front end thereof returns to the inside of the electrode holder and is fixed.
  • the electrode holder and the lumen inside the catheter body return to the rear end of the catheter body and are fixed on the control handle. Or it is fixed on the control member.
  • the front end of the adhering wire is fixed to the front end of the electrode holder after returning to the inside of the electrode holder.
  • the front end of the adhering wire is returned to the inside of the electrode holder, the front end of the electrode holder is fixed or restricted to the outside; the anchoring wire is at the same time a support wire.
  • a support wire fixedly disposed in a certain lumen of the connecting catheter and the electrode holder, and the front end of the adhering regulating wire is fixed on the support wire; or
  • the anchoring wire is a filament that is outwardly separated from the support wire.
  • the portion of the support wire inside the electrode holder is shaped into a spiral to form a spiral shaped section.
  • the adhering adjustment wire is exposed outside the electrode holder
  • the point at which the adhering wire is exposed outside the electrode holder is fixed in a hole of a spiral section of the electrode holder.
  • the adherent adjustment wire is composed of a plurality of wires, wherein the front end of each wire is fixed on the electrode holder, and the rear end is externally bypassed by a spiral segment of the electrode holder and then enters the electrode holder or the catheter.
  • the inside of the tube body is then passed through the lumen of the catheter tube body from the end of the catheter tube body and fixed to a corresponding control member disposed on the control handle, or fixed to the peripheral device after passing through the control handle
  • the plurality of wires are respectively used for independently controlling the diameters of different spiral segments of the electrode holder.
  • the plurality of wires have different fixing points on the electrode holder.
  • each of the two filaments has a common fixed point on the electrode holder.
  • each strand enters the interior of the electrode holder from a different location on the electrode holder.
  • the plurality of filaments have the same fixing point on the electrode holder.
  • a radio frequency ablation device comprising the radio frequency ablation catheter described above and a radio frequency ablation host coupled to the radio frequency ablation catheter.
  • the radiofrequency ablation catheter provided by the invention can provide a radiofrequency ablation catheter with a different structure to adapt to a target lumen of different diameters by providing a support anchoring wire or an adherent adjustment wire having a different structure, and attaching the electrode on the electrode holder The wall is in good condition.
  • the electrode attached to the electrode holder can be attached in a good state by pulling the anchoring wire.
  • the anchoring wire can also adopt the structure of multi-strand wire.
  • 1a is a schematic structural view of a radio frequency ablation catheter of a spiral structure provided by the first embodiment
  • Figure 1b is a side elevational view of the radiofrequency ablation catheter of Figure 1a;
  • Figure 1c is a schematic view showing the structure of the control handle of the radiofrequency ablation catheter shown in Figure 1a;
  • FIG. 2 is a schematic cross-sectional view of an electrode holder in a spiral ablation catheter of a spiral structure according to a first embodiment
  • FIG. 3 is a schematic structural view of a first type of anchoring wire in a radio frequency ablation catheter of a spiral structure according to the first embodiment
  • FIG. 4 is a D-D cross-sectional view of a radio frequency ablation catheter with a helical structure when the rigid section supporting the adherent wire is overlapped with the electrode holder;
  • Figure 5 is a partially enlarged schematic view showing a portion of the radiofrequency ablation catheter of the helical structure shown in Figure 4;
  • Figure 6a is a schematic view showing the structure of a radio frequency ablation catheter with a spiral structure when the flexible section supporting the adherent wire is overlapped with the electrode holder;
  • Figure 6b is a side elevational view of the radiofrequency ablation catheter of Figure 6a;
  • Figure 7a is a schematic view showing the state of the control handle when the button control member advances the wire, and the rigid portion of the control wire coincides with the electrode holder;
  • Figure 7b is a schematic view showing the state of the control handle when the button control member is moved back and the control wire is overlapped with the electrode holder;
  • FIG. 8 is a schematic structural view of a second type of supporting anchoring wire in the spiral ablation catheter of the spiral structure provided by the first embodiment
  • FIG. 9 is a schematic structural view of a third type of supporting wall adjusting wire in the spiral ablation catheter of the spiral structure provided by the first embodiment
  • FIG. 10 is a schematic cross-sectional view of a radio frequency ablation catheter using a fourth type of anchoring wire in a spiral ablation catheter provided in a first embodiment
  • FIG. 11 is a schematic structural view of a fifth type of supporting anchoring wire in the spiral ablation catheter of the spiral structure provided by the first embodiment
  • FIG. 12 is a schematic structural view of a sixth type of supporting anchoring wire in the spiral ablation catheter of the spiral structure provided by the first embodiment
  • Figure 13 is a schematic view showing another structure of the control handle in the spiral ablation catheter of the spiral structure provided by the first embodiment
  • FIG. 14 is a schematic structural view of an electrode holder and a catheter tube in a spiral ablation catheter of a spiral structure according to a second embodiment
  • Figure 15 is a cross-sectional view of the electrode holder in the radiofrequency ablation catheter of the helical structure shown in Figure 14;
  • Figure 16 is a cross-sectional view of the A-A of the radiofrequency ablation catheter of the helical structure shown in Figure 14;
  • FIG. 17 is an enlarged schematic view showing a portion II of the radiofrequency ablation catheter of the spiral structure shown in FIG. 16;
  • 18 is a schematic view showing another arrangement manner of the adhering regulating wire in the spiral ablation catheter of the spiral structure provided by the second embodiment;
  • 19 is a schematic structural view of a control handle in a spiral ablation catheter of a spiral structure according to a second embodiment
  • 20A is a schematic view showing an initial state of a radio frequency ablation catheter of the spiral structure shown in FIG. 14;
  • Figure 20B is a side elevational view of the radiofrequency ablation catheter of the helical configuration of Figure 20A;
  • Figure 21 is a schematic view showing the state of the radiofrequency ablation catheter of the helical structure shown in Figure 14 in the sheath;
  • Figure 22 is a schematic view showing the state of use of the radiofrequency ablation catheter of the helical structure shown in Figure 14 in a thin blood vessel;
  • FIG. 23A is a schematic view showing the state of use of the radiofrequency ablation catheter of the helical structure shown in FIG. 14 in a relatively thick blood vessel;
  • Figure 23B is a side elevational view of the radiofrequency ablation catheter of the helical configuration of Figure 23A;
  • 24 is a schematic structural view of an electrode holder and a catheter body in a spiral ablation catheter of a spiral structure according to a third embodiment
  • Figure 25 is a schematic view showing the state of use of the radio frequency ablation catheter of the helical structure shown in Figure 24;
  • 26A is a schematic view showing a state of use of a control handle in a spiral ablation catheter of a spiral structure according to a third embodiment
  • 26B is a schematic view showing still another use state of the control handle in the spiral ablation catheter of the spiral structure provided by the third embodiment
  • Figure 27 is a schematic view showing the structure of the electrode holder and the catheter tube in the spiral ablation catheter of the spiral structure according to the fourth embodiment
  • FIG. 28 is a schematic structural view of a support wire in a spiral ablation catheter of a spiral structure according to a fourth embodiment
  • 29 is a schematic structural view of an electrode holder and a catheter body in a spiral ablation catheter of a spiral structure according to a fifth embodiment
  • FIG. 30 is a schematic structural view of a support wire and an adherent regulating wire in a spiral ablation catheter of a spiral structure according to a fifth embodiment
  • FIG. 31A is a schematic structural view of an electrode holder and a catheter body in a spiral ablation catheter of a spiral structure according to a sixth embodiment
  • Figure 31B is a side elevational view of the radiofrequency ablation catheter of the helical configuration of Figure 31A;
  • 32A is a schematic structural view of an electrode holder and a catheter tube in a spiral ablation catheter of a spiral structure according to a seventh embodiment
  • Figure 32B is a side elevational view of the radiofrequency ablation catheter of the helical configuration of Figure 32A;
  • 33 is a schematic view showing the internal structure of the electrode holder in the spiral ablation catheter of the spiral structure provided by the seventh embodiment
  • FIG. 34A is a schematic view showing a state in which the electrode-attached wire is pulled back after the electrode holder is attached to the radiofrequency ablation catheter of the spiral structure provided by the seventh embodiment;
  • Figure 34B is a side elevational view of the radiofrequency ablation catheter of the helical configuration of Figure 34A;
  • 35 is a schematic structural view of an adherent adjusting wire in a spiral ablation catheter of a spiral structure according to an eighth embodiment
  • 36A is a schematic view showing another structure of the adhering regulating wire in the spiral ablation catheter of the spiral structure provided by the eighth embodiment;
  • FIG. 36B is another schematic structural view of the adhering regulating wire in the spiral ablation catheter of the spiral structure provided by the eighth embodiment.
  • FIG. 36B is another schematic structural view of the adhering regulating wire in the spiral ablation catheter of the spiral structure provided by the eighth embodiment.
  • the spiral ablation catheter of the spiral structure provided by the present invention comprises an elongated catheter tube body, and a spiral electrode holder is arranged at the front end of the catheter tube body, and the initial diameter of the spiral shape of the electrode holder is ⁇ D.
  • the initial length is A-1 (see Figures 1a and 1b).
  • ⁇ D should be larger than the diameter of the target lumen, and a control handle 8 is provided at the rear end of the catheter body (see Figure 1c).
  • the electrode holder can be integrally formed with the catheter tube body, and the electrode holder is a spiral-shaped portion at the front end of the catheter tube body; the electrode holder can also be independently fabricated and then integrated with the catheter tube body.
  • the spiral electrode holder includes an outer tube 1 and a plurality of electrodes 2 disposed on the outer tube 1.
  • the electrode 2 may be a block electrode or a ring electrode embedded on the outer circumference of the outer tube 1, and the upper surface of the electrode 2 may be flush with the outer surface of the outer tube 1 or slightly higher than the outer surface of the outer tube 1, the electrode 2 The upper surface may also be lower than the outer surface of the outer tube 1.
  • the inside of the electrode holder and the catheter body are respectively provided for accommodating the support anchoring wire
  • the lumen of 6 is provided with a supporting anchoring wire 6 (see FIG. 2) in the corresponding lumen of the electrode holder and the catheter body, and the supporting anchoring wire 6 can be in the corresponding lumen of the electrode holder and the catheter body
  • the lumen for accommodating the front and rear adjustment wires 6 may be a central hole of the electrode holder and the catheter body, or may be one of a plurality of lumens distributed around the center. As shown in FIG.
  • the head end of the supporting wall adjusting wire 6 is restricted to the outside of the electrode holder after passing through the electrode holder, and can be moved away from the catheter tube body with respect to the distal end of the electrode holder to support the adherence.
  • the head end of the adjusting wire 6 is provided with a developing head 63; as shown in Fig. 1c, the trailing end of the supporting wall adjusting wire 6 passes through the center hole of the catheter tube body and is fixed on the control handle 8, and the control handle 8 is used.
  • the control support anchoring wire 6 is moved back and forth.
  • the control handle 8 is provided with a button control member 9.
  • the tail end of the support wall adjusting wire 6 is fixed to the button control member 9 through the center hole inside the catheter tube body, and the button moving member 9 is changed on the control handle 8 by changing the button. Position, control support the adhering wire 6 moves back and forth.
  • the above-mentioned spiral structure radiofrequency ablation catheter realizes the diameter change of the electrode holder by improving the structure of the supporting adhering wire 6, making it easy to insert the guiding catheter/sheath and the target lumen, and at the same time, reaching the target lumen The natural spiral can be restored.
  • the support adhering wire 6 has two sections of a flexible section 61 (close to the head end) remote from the control handle 8 and a rigid section 62 (near the tail end) adjacent to the control handle 8;
  • the length of the flexible section 61 is preferably not less than the length of the outer tube 1 of the electrode holder.
  • the length of the flexible section 61 may also be smaller than the length of the outer tube 1 of the electrode holder.
  • the diameter of the spiral shape of the electrode holder can be changed by changing the overlapping area of the support wall adjusting wire 6 and the electrode holder by the control handle 8.
  • the spiral shape of the electrode holder is under the action of the rigid section 62 supporting the adhering regulating wire 6.
  • the diameter is reduced, the length becomes longer, and it tends to be linear.
  • the electrode holder can assume a linear shape A as shown in FIG.
  • the electrode holder is restored in a spiral shape having a diameter ⁇ C equal to or close to the diameter of the target lumen (see Fig. 6b), at which time the spiral length A-2 of the electrode holder is greater than the initial length A-1. That is to say, in the radio frequency ablation catheter, the spiral support of the electrode holder can be reduced by controlling the support of the adhering adjustment wire 6 to advance so that the rigid section 62 and the outer tube 1 of the electrode holder overlap.
  • the diameter is adapted to enter the guiding catheter/sheath or the target lumen, and at the same time, the electrode holder reaches the target lumen, and the sheathing adjustment wire 6 is supported by the post-tensioning to make the flexible section 62 and the outer tube of the electrode holder 1 coincides, the electrode holder can be restored to a spiral shape to achieve adhesion.
  • the position of the button control 9 on the control handle 8 can be as shown in Figures 7a and 7b.
  • the electrode 2 can be finely adjusted by further pulling the supporting adjustment wire 6, so that the electrode 2 is in close contact with the tube wall to improve the adherence state of the electrode 2.
  • the supporting anchoring wire 6 since the supporting anchoring wire 6 is disposed inside the electrode holder, when the flexible segment 61 supporting the adhering wire 6 is overlapped with the outer tube of the electrode holder, the supporting anchoring wire 6 is pulled again to support the adhering
  • the adjustment wire 6 has a small amplitude of motion and is therefore only used to fine tune the shape of the electrode holder.
  • radiofrequency ablation catheter When selecting a radiofrequency ablation catheter, it is recommended to select a radiofrequency ablation catheter with a spiral diameter ⁇ D greater than or close to the diameter of the target lumen, so that when the electrode stent automatically expands in the target lumen, the spiral is restored, in the vessel wall It can be closely attached to the wall.
  • the radiofrequency ablation catheter has a good adherence effect on a target lumen having a diameter less than or equal to the initial diameter of the spiral. Since the diameter of the human renal artery is in the range of 2 to 12 mm, in order to ensure that the above-mentioned radiofrequency ablation catheter has good adaptability to thicker and thinner blood vessels, it is recommended to use a radiofrequency ablation catheter with ⁇ D>12 mm.
  • the present invention also provides a radio frequency ablation catheter supporting the adherent adjustment wire 6 having a branch (see FIGS. 10, 11, and 12).
  • the initial diameter ⁇ D of the spiral shape of the electrode holder may be smaller than the diameter of the target lumen.
  • the support adhering wire 6 has a branch extending rearward from the flexible segment 61, that is, the furcation adjusting wire 66 in Figs.
  • the head end of the branch adjusting wire 66 is fixed to the supporting adhering wire 6
  • the head end, or the head end of the furcation adjusting wire 66 is fixed to a certain portion of the flexible segment 61, or the furcation adjusting wire 66 is a filament which is branched outward from the flexible segment 61, and the rear end of the fork regulating wire 66 It is pierced from the hole 11 provided in the outer tube 1 of the electrode holder, and penetrates from the hole 15 provided in the outer tube of the electrode holder or the hole in the tube tube, and then is juxtaposed along with the support wall adjusting wire 6
  • the lumen inside the catheter body extends beyond the tube and into the interior of the control handle 8 and is attached to the second control member of the control handle 8 (or a separately provided second control member).
  • the electrode holder When using the above snail in thicker blood vessels When the radiofrequency ablation catheter of the rotating structure is restored, the electrode holder cannot be attached to the wall after returning to the natural spiral shape. At this time, the diameter of the spiral shape of the electrode holder can be enlarged by pulling the branch supporting the adhesion adjusting wire 6 (ie, the bifurcated adjusting wire 66). It is adapted to a blood vessel having a relatively large diameter, and the structural content of the portion will be specifically described below.
  • the outer tube 1 of the electrode holder may be a single lumen tube or a multi-lumen tube, and the outer tube 1 may be made of a polymer material or a metal material such as stainless steel or a memory alloy.
  • the outer tube 1 can be processed by straight pipe or bar, and can also be made into a spiral special shape tube using the A section. As shown in FIG. 2 and FIG. 5, when the outer tube 1 uses a multi-lumen tube, a plurality of lumens are disposed outside the center tube of the outer tube 1 of the electrode holder, and a plurality of lumens are disposed in each of the tubes.
  • thermocouple wire 4 The RF cable 3 and the thermocouple wire 4 are assembled, and the thermocouple wire 4 is covered by the thermocouple wire end insulating layer 5 to be isolated from the RF line 3 and the electrode 2, and the head ends of each set of the RF line 3 and the thermocouple wire 4 are disposed in a single The inside of the electrode, wherein the head end of the RF wire 3 is tightly welded to the electrode 2; the tip end of the thermocouple wire 4 is welded and insulated from the electrode 2.
  • a spiral shaping wire 7 is also disposed in one of the lumens of the outer tube 1, and the helical shaping wire 7 is fixed in the section of the helical deformation zone A for supporting the spiral shape of the electrode holder.
  • the arrangement of the screw setting wire 7 can be omitted.
  • the electrode 2 is fixed to the outer tube 1, and its outer surface may be lower or lower than the outer surface of the outer tube 1.
  • the plurality of electrodes 2 are uniformly or unevenly distributed in the circumferential direction on the spiral shape of the electrode holder, and the plurality of electrodes may be distributed on the electrode holder in one turn, one turn or more or less than one turn.
  • the inner surface of the electrode 2 is firmly welded to the radio frequency wire 3; the tip end of the thermocouple wire 4 is welded together, and the thermocouple wire end insulating layer 5 is coated at the tip end of the thermocouple wire 4 to be insulated, and then set.
  • the thermocouple wire end insulating layer 5 may be a heat shrinkable tube or other sleeve.
  • the first type of supporting anchoring wire 6 provided by the present invention comprises two parts of a flexible section 61 near the head end and the remaining rigid section 62.
  • a developing head can be arranged on the head end of the supporting wall adjusting wire 6. 63, used to develop imaging of the target lumen.
  • the two supporting anchoring wire shown in Figs. 8 and 9 includes a flexible segment 61 and a rigid segment 62, and at the same time, a straight flexible guide wire 64 is disposed at the front end of the flexible segment 61 supporting the adherent adjusting wire 6. Or the elbow soft guide wire 65, so that the support adhering wire 6 can replace the guiding catheter/sheath and directly enter the blood vessel, simplifying the surgical operation. Since the guiding catheter/sheath is omitted, the diameter of the catheter that enters the blood vessel can be reduced to a large extent, facilitating the movement of the catheter.
  • the three supporting adhering regulating wires shown in Figs. 10 to 12 have bifurcated adjusting wires 66, respectively, and the structures of the three bifurcated adjusting wires 66 are slightly different.
  • the head end of the branching regulating wire 66 is fixed to the head end of the supporting adhering wire 6, and then extends rearward together with the flexible segment 61.
  • the rear end of the bifurcated wire 66 is pierced from the hole 11 provided in the outer tube 1 of the electrode holder, and penetrates into the corresponding lumen from another hole 15 provided on the electrode holder or the catheter tube, and then is attached to the support.
  • the wall regulating wires 6 extend side by side along the lumen inside the catheter body to the outside of the tube and are fixed to the second control member of the control handle 8.
  • the head end of the branching regulating wire 66 is fixed to a certain portion of the flexible section 61, or the branching regulating wire 66 is separated from the flexible section 61.
  • the filament, and then the rear end of the bifurcated wire 66 is pierced from a hole provided in the outer tube 1 of the electrode holder, and penetrated from another hole provided in the electrode holder or the catheter tube, and then adhered to the support
  • the adjustment wires 6 extend side by side along the lumen inside the catheter body to the outside of the tube and are secured to the second control member of the control handle.
  • the bifurcated adjusting wire is arranged in a similar manner to the structure of the fourth supporting adhering regulating wire.
  • the flexible section adopts a spring structure
  • the branching regulating wire 66 is a filament which is branched outward from a certain portion of the spring 61-1, and the head end of the branching regulating wire 66 is fixed to the spring.
  • the rear end of the bifurcated wire 66 is pierced from a hole provided in the outer tube 1 of the electrode holder, and penetrates from another hole provided in the electrode holder or the catheter tube, and then the rigidity of the wire 2 is supported and supported.
  • the segments 62-1 extend side by side along the lumen inside the catheter body to the outside of the tube and into the control handle 8 and are attached to the second control member of the control handle.
  • the above three kinds of support anchoring wire are used, and when the radiofrequency ablation catheter recovers the natural spiral shape in the blood vessel or the target lumen having a diameter larger than the spiral initial diameter ⁇ D, the wall cannot be attached, and the bifurcation adjustment is performed by the second control member.
  • the wire 66 can expand the diameter of the electrode holder to adhere the electrode.
  • the end 67 of the supporting applique adjusting wire 6 is fixed on the button control member 9, and its push control member 9 is changed on the control handle 8.
  • the position can change the shape of the electrode holder; and the furcation adjusting wire 66 projects from an opening provided on the remaining side of the control handle 8, and fixes the second control member 10 at its end 68, by pulling on the outside of the control handle 8.
  • the second control member 10 can further change the spiral diameter of the electrode holder.
  • the flexible section 61 of the supporting anchoring wire 6 of FIG. 10 is the same as the structure of the first three supporting adhering filaments shown in FIGS. 3, 8, and 9, and the flexible section 61 is constructed by a filament or a hose.
  • the flexible section 61 can be made of a filament having a diameter smaller than that of the rigid section.
  • the flexible section 61 and the rigid section 62 can be integrally formed of the same material or can be assembled from two filaments of different diameters (for example, using a welding process). ).
  • the flexible section 61 can also be constructed in a hose.
  • the support member is shown in Fig. 12.
  • the flexible section 61-1 adopts a spring structure.
  • the flexible section 61-1 is located inside the electrode holder, since the spring has good bending performance, the electrode holder is in the spiral shaping wire 7. The spiral shape can be restored under action, and the flexible segment 61-1 is deformed accordingly.
  • the spiral ablation catheter of the spiral structure provided by the first embodiment is described above.
  • the support-attachment adjustment wire in the spiral-structured radiofrequency ablation catheter is improved by referring to the structure of the guide wire.
  • the specific roles of the two are different.
  • the flexible segment is used to actively adapt to the shape of the blood vessel, changing the orientation of the guide wire so that it smoothly reaches the target lumen; the rigid segment is used to support the guide wire.
  • the spiral ablation catheter provided by the present invention by controlling the overlap of the electrode holder and the different regions supporting the adherent adjustment wire 6, changing the shape of the electrode holder, the radiofrequency ablation catheter can be reduced from entering the guiding catheter/sheath. Difficult, simple structure and easy to operate.
  • the spiral electrode holder When the supporting anchoring wire 6 is moved forward to the rigid section and the spiral electrode holder 2 is overlapped, the spiral electrode holder has a reduced diameter and a longer length, which tends to be linear, under the action of the rigid section supporting the anchoring wire 6. , thereby facilitating access to the guiding catheter/sheath while facilitating movement of the entire radiofrequency ablation catheter in the target lumen; and when the supporting adhering wire 6 is retracted until the flexible segment and the spiral electrode holder are coincident, the spiral electrode holder recovers the spiral Shape, can be attached; and, by continuing Pulling the support anchoring wire backwards also improves the adherence of the electrodes.
  • the support adherent wire can also directly enter the blood vessel instead of the guiding catheter/sheath, simplifying the operation.
  • the use of the above-mentioned supporting anchoring wire not only simplifies the difficulty of the radiofrequency ablation catheter entering the human blood vessel, but also can further change the expansion diameter of the spiral electrode stent by pulling the supporting anchoring wire to make the target of different diameters The adaptability of the lumen is good.
  • the diameter of the spiral of the electrode holder is adjusted using a support anchoring wire disposed in a lumen of the electrode holder.
  • an adherent adjustment wire passing through or around the electrode holder may be disposed in the spiral ablation catheter to adjust the expansion diameter of the electrode holder to target different diameters. The adaptability of the lumen is good, as described in detail below.
  • the spiral ablation catheter of the present invention comprises a long-shaped catheter tube body, and a spiral electrode holder is arranged at the front end of the catheter tube body, and a rear end of the catheter tube body is disposed at the rear end of the catheter tube body.
  • Control handle 20 (see Figure 19).
  • the electrode holder can be integrally formed with the catheter tube body, and the electrode holder is a portion in which the front end of the catheter tube body is shaped into a spiral shape; the electrode holder can also be independently fabricated and then integrated with the catheter tube body.
  • the spiral electrode holder includes an outer tube 1 and one or more electrodes 2 disposed on the outer tube 1.
  • the electrode 2 may be a block electrode or a ring electrode embedded on the outer circumference of the outer tube 1, and the upper surface of the electrode 2 may be flush with the outer surface of the outer tube 1 or slightly higher than the outer surface of the outer tube 1, the electrode 2 The upper surface may also be lower than the outer surface of the outer tube 1.
  • the plurality of electrodes 2 are uniformly or unevenly distributed in the circumferential direction on the spiral shape of the electrode holder, and the plurality of electrodes may be distributed on the electrode holder in one turn, one turn or more or less than one turn.
  • the outer tube 1 of the electrode holder may be a single lumen tube or a multi-lumen tube, and the outer tube 1 may be made of a polymer material or a metal material such as stainless steel or a memory alloy.
  • the outer tube 1 can be processed by straight pipe or bar, and can also be made into a spiral special shape tube using the A section. As shown in FIG. 15 and FIG. 17, when the outer tube 1 uses a multi-lumen tube, a plurality of lumens are disposed outside the central tube outside the outer tube 1 of the electrode holder, and a plurality of lumens are respectively disposed in some of the lumens.
  • thermocouple wires 4 there is a set of RF lines 3 and thermocouple wires 4, each set of RF lines 3 and thermocouple wires 4
  • the head end is disposed inside the single electrode 2, wherein the head end of the RF line 3 is tightly fixed to the electrode 2, such as using soldering, conductive adhesive bonding, etc.; the ends of the two thermocouple wires 4 are soldered and The thermocouple wire end insulating layer 5 is coated and then insulated from the RF line 3 and the electrode 2.
  • a spiral shaping wire 6 is further disposed in one of the lumens of the outer tube 1, and the helical shaping wire 6 is fixed in the spiral deformation region for supporting the spiral shape of the electrode holder.
  • the electrode holder can also be directly shaped into a spiral shape, thereby eliminating the need for the spiral shaped wire 6.
  • the setting screw 6 can be omitted.
  • a support wire 7 is disposed in the central lumen of the catheter body and the electrode holder, and the support wire 7 may be movably disposed in the central lumen or may be fixedly disposed in the central lumen, or The support wire 7 can also be placed in the catheter body and other lumens of the electrode holder.
  • a head can be provided at the head end of the support wire 7 for instant imaging of the inside of the target lumen.
  • a soft guide wire 9 may be disposed at the front end of the support wire 7.
  • the soft guide wire 9 may be a straight soft guide wire or a soft guide wire as shown in the figure, so that the radio frequency ablation catheter can be omitted. Guide the catheter/sheath directly into the blood vessel, simplifying the operation.
  • the inside of the catheter tube body is further provided with a lumen for accommodating the adhering regulating wire 8, and the rear portion of the adhering regulating wire 8 is slidably disposed in one of the lumens of the catheter body.
  • the rear end 80 passes through the catheter body and then passes through the control handle 20, and then passes out of the control handle 20 and is then connected to the peripheral control member 22 (see Fig. 19).
  • the adherent adjustment wire 8 can slide back and forth within the lumen of the catheter body.
  • the lumen for receiving the adherent adjustment wire 8 may be a central lumen or one of a plurality of eccentric lumens distributed around the central lumen. As shown in Fig.
  • the front portion of the adherend adjusting wire 8 passes through the outside of the electrode holder from the hole 12 near the rear end of the electrode holder, is exposed to the outside of the electrode holder, and its front end is returned to the electrode from the hole 11 near the front end of the electrode holder.
  • the inside of the bracket is fixed.
  • the fixing position of the front end of the adhering wire 8 may be different, may be fixed at the front end of the electrode holder, may be fixed at the front end of the support wire 7, may be fixed on the screw shaping wire 6, or may pass through
  • the electrode holder and the corresponding lumen inside the catheter body are returned to the rear end of the catheter tube body and are fixed to the control member 22 together with the rear end of the adhering wire 8.
  • the front end of the adhering wire 8 is returned from the hole 11 near the front end of the electrode holder to the inside of the electrode holder, and passes through the electrode holder and the catheter body.
  • the lumen of the portion is returned to the rear end of the catheter body together with the rear end of the adhering wire 8, and then the front end and the rear end of the adhering wire 8 can be fixed together in the same control member as shown in FIG. 22, or, the front end and the rear end of the fitting wire 8, one end of which is fixed to the casing of the control handle 20, and the other end is fixed to the control member 22.
  • the diameter of the spiral section of the electrode holder can be changed.
  • the front end of the adhering wire 8 can also be simply fixed to the front end of the electrode holder, or fixed to the front end of the support wire 7 or a portion of the support wire 7 located inside the electrode holder, or fixed to the spiral shaping wire 6.
  • the anchor wire 8 and the support wire 7/spiral wire 6 can be made of the same material, which can be understood as adherence.
  • the adjusting wire 8 is a filament which is supported by the support wire 7/spiral shaped wire 6 backward.
  • the front end of the adhering wire 8 is fixed to the front end of the screw setting wire 6, and at this time, the screw setting wire 6 and the adhering wire 8 can be made of the same type of filament.
  • the adherent adjusting wire 8 and the helical shaped wire 6 are respectively two filament branches which are separated backward from the front end thereof, wherein the branch corresponding to the helical shaped wire 6 is fixed in a certain lumen of the electrode holder, corresponding to the adherence
  • the rear section of the branch of the adjustment wire 8 can slide in the lumen of the electrode holder and/or catheter body.
  • the front end/front portion of the wall-adjusting wire 8 and the screw-shaped wire can be used. 6 assembled by welding, riveting, bonding, etc.
  • a button control member 21 is further disposed on the control handle 20, and the end 70 of the support wire 7 passes through the catheter tube body and enters the control handle 20, and is fixed at the button.
  • the control member for connection with the end of the support wire 7 can be disposed on the outside of the control handle 20 in the same manner as the control member 22, except for being disposed on the control handle 20 as shown in the figure.
  • the control member to which the wire 8 is attached may also be disposed on the control handle 20 as the button control member 21.
  • FIGS. 20A-23B are schematic views showing the state of use of a helically structured radiofrequency ablation catheter in different diameter lumens in a second embodiment provided by the present invention.
  • Figure 20A and Figure 20B As shown in the figure, a radio frequency ablation catheter having an initial diameter ⁇ B of a spiral electrode holder of 10 mm and an axial distance A of the head and tail electrodes is taken as an example. When it enters the sheath of ⁇ 2 mm, the shape of the electrode holder is close to a straight line as shown in FIG. When it protrudes from the sheath into the blood vessel of ⁇ 4 mm, the diameter ⁇ B-3 of the spiral shape of the electrode holder is limited by the diameter of the blood vessel by about 4 mm.
  • the electrode is tightly close to the tube wall under the natural expansion of the electrode holder.
  • FIG. 23A and FIG. 23B when it protrudes from the sheath into the blood vessel of ⁇ 12 mm, after the electrode stent is naturally expanded, since the initial diameter ⁇ B is smaller than the diameter of the target lumen, the electrode 2 cannot be attached to the wall.
  • the adherent adjusting wire 8 backward the diameter of the spiral shape of the electrode holder can be increased to ⁇ B-4, which is equal to the diameter of the target lumen, and the plurality of electrodes 2 are tightly attached to the tube wall under the action of the adhering regulating wire 8. contact.
  • the axial distance between the first and last electrodes is reduced to A-4, and the axial spacing of the plurality of electrodes is reduced.
  • the diameter of the target lumen is large, the ablation of the plurality of electrodes can be prevented from affecting each other, and thus Cause excessive ablation.
  • the plurality of electrodes 2 uniformly distributed on the spiral shape of the electrode holder have a smaller axial distance under the action of the adhering regulating wire 8. The spiral pitch does not change.
  • 20A to 23B are exemplified by an electrode holder having a ⁇ B of 10 mm.
  • the initial diameter of the spiral shape of the electrode holder is other values (for example, 6 mm, 8 mm)
  • the plurality of electrodes can also be in close contact with the tube wall at the same time.
  • the wall is in good condition.
  • the radiofrequency ablation catheter shown in Fig. 24 is similar in structure to the radiofrequency ablation catheter of the second embodiment, and its contraction state is shown in Fig. 25.
  • 26A and 26B are schematic views showing the state of use of the control handle 20 of the radio frequency ablation catheter in different states, respectively.
  • a spiral shaping wire 6 is disposed in the electrode holder, and a support wire 7 is disposed in the catheter body and the electrode holder.
  • the portion of the support wire 7 corresponding to the electrode holder is exposed outside the electrode holder, and the portion of the support wire 7 corresponding to the catheter body is disposed in a certain lumen of the catheter body, and the rear end thereof is worn from the catheter tube After being released, it is fixed to the control member 25 provided on the control handle 20.
  • the support wire 7 By pulling the support wire 7, the spiral shape of the electrode holder can be changed, and the support wire 7 simultaneously functions as the anchoring wire 8.
  • the rear section of the adhering wire 8 is slidably disposed in a certain lumen of the catheter body, and the rear end thereof is connected to the control handle 20; the front section of the adhering wire 8 is exposed from the hole 12 after exiting the electrode holder The outer portion of the electrode holder, and the front end thereof returns from the hole 11 to the inside of the electrode holder, passes through the front end of the electrode holder and is fixed or restricted to the outside; the anchoring wire 8 is also a support wire of the catheter body.
  • a developing head and/or a soft guide wire 9 may be disposed at the front end of the fitting wire 8.
  • only one control member 25 connected to the support wire 7 may be disposed on the control handle 20.
  • the control member 25 is used for the telescopic state of the electrode holder. Adjustment. By pushing the control member 25 from the position shown in Fig. 26A to the position shown in Fig. 26B, the support wire 7 can be pulled back, that is, the adhering wire 8 is pulled back to increase the spiral diameter of the electrode holder.
  • the radio frequency ablation catheter shown in Fig. 27 is similar in structure to the radio frequency ablation catheter of the second embodiment, and Fig. 28 shows the structure of the support wire 7 of the radiofrequency ablation catheter in the fourth embodiment.
  • the structure of the adhering regulating wire 8 is the same as that of the second embodiment.
  • the rear section of the adhering wire 8 is slidably disposed in a certain lumen of the catheter body, and the rear end thereof is connected to the control member 22 disposed on the control handle 20 or is connected to the control handle 20 and connected to the outside.
  • the control member 22 is disposed; the front portion of the adhering wire 8 is exposed from the hole 12 to the outside of the electrode holder, and the front end thereof is returned from the hole 11 to the inside of the electrode holder, and can be fixed at the front end of the electrode holder.
  • the housing of the handle 20 or the control member 22 is provided. By pulling the control member 22, the diameter of the spiral section of the electrode holder can be changed.
  • the helical sizing wire is not independently provided, and as shown in Fig. 28, the portion of the front portion of the support wire 7 corresponding to the electrode holder is shaped into a spiral shape by pre-setting, and the spiral sizing portion 76 is formed.
  • the support wire 7 is fixedly disposed in a certain lumen of the electrode holder and the catheter tube body, so that the corresponding portion of the electrode holder can be spiraled.
  • the adhering wire 8 may be disposed in the same lumen of the catheter body together with the support wire 7, or may be separately disposed in a single lumen of the catheter body.
  • the radio frequency ablation catheter shown in FIG. 29 is similar in structure to the radio frequency ablation catheter of the second embodiment, and FIG. 30 shows the structure of the support wire 7 and the adhering adjustment wire 8 of the radio frequency ablation catheter in the fifth embodiment, wherein The support wire 7, the anchoring wire 8 and the screw setting wire 6 are integrally provided.
  • the support wire 7 is disposed inside the catheter tube body and the electrode holder, and the spiral shaping wire is not independently disposed inside the electrode holder.
  • the portion of the front portion of the support wire 7 corresponding to the electrode holder is shaped into a spiral shape by presetting, and the spiral shaped segment 76 is formed.
  • the adhering regulating wire 8 is integrally provided with the supporting wire 7, and the front end of the adhering regulating wire 8 is fixed to the supporting wire 7, or the adhering regulating wire 8 is a filament which is branched outward from the supporting wire 7.
  • the front section of the adherent adjusting wire 8 is exposed from the hole 11 to the outside of the electrode holder, and is returned from the hole 12 to the inside of the electrode holder/duct body, and then the rear portion thereof slidably passes through the inside of the catheter body A lumen is returned to the rear end of the catheter shaft and is secured to the control member 22. By pulling the control member 22, the diameter of the spiral section of the electrode holder can be changed.
  • the rear section of the adherent adjustment wire 8 may be disposed in a lumen of the catheter tube together with the support wire 7, or may be independently disposed in another lumen of the catheter body.
  • 31A and 31B are schematic views showing the structure of a radio frequency ablation catheter in the sixth embodiment.
  • the portion exposed to the outside of the electrode holder is still located in the electrode holder. Near the center of the spiral.
  • the adhering wire 8 is pulled backward, the electrode holder is axially contracted, and the adhering wire 8 is inserted through the center of the spiral; when the spiral of the electrode holder is elongated to a straight line, the adjusting wire 8 is attached.
  • the portion exposed to the outside of the electrode holder is in close proximity to the outer tube 1 of the electrode holder.
  • the adhering regulating wire 8 is not disposed near the center position of the spiral shape of the electrode holder, but is eccentrically disposed at the outer circumferential position of the spiral. As shown in FIG. 31A and FIG. 31B, when the adhering regulating wire 8 is eccentrically disposed at the outer circumferential position of the spiral shape of the electrode holder, the portion of the adhering regulating wire 8 exposed to the outside of the electrode holder does not pass through the spiral inner portion. Instead, it bypasses the side of the spiral outer. When the adhering wire 8 is pulled backward, the spiral segment of one or more turns between the holes 11 and 12 of the electrode holder is contracted and deformed to become a new spiral, thereby increasing the spiral. The existing diameter of the shape is used to achieve diameter expansion.
  • the diameter of the contracted spiral can be greatly increased.
  • the electrode holder can be applied to a blood vessel having a diameter larger than the diameter of a single spiral section of the electrode holder. Since the diameter of the human blood vessel is fixed, the initial diameter of the spiral of the electrode holder in the radiofrequency ablation catheter can be greatly reduced, which facilitates the radiofrequency ablation catheter to enter and move inside the blood vessel.
  • FIG. 32A to FIG. 34B are schematic diagrams showing the structure of a radio frequency ablation catheter according to a seventh embodiment of the present invention, wherein a fixed point exists between a portion of the adherent adjustment wire 8 exposed outside the electrode holder and the electrode holder.
  • the front end and the rear end of the wall-adjusting wire 8 are both passed out from the rear end of the catheter tube body and fixed to a corresponding control member disposed on the control handle 20 or external to the control handle 20.
  • the anchoring wire 8 and the middle portion of the electrode holder have a fixing point 13, and the front portion 81 of the adhering wire 8 is passed forward from the fixing point 13 to the electrode holder.
  • the rear section 82 of the adherent adjustment wire 8 is rearward from the fixed point 13
  • the outside of the electrode holder is bypassed and returned from the hole 12 near the rear end of the electrode holder to the inside of the electrode holder, and returned to the control handle 20 via the electrode holder and the lumen inside the catheter tube.
  • the front section 81 and the rear section 82 of the adherent adjustment wire 8 can be returned to the control handle 20 via the same lumen in the electrode holder and catheter body, or can be returned to the control handle 20 via different lumens as shown in FIG.
  • a control member may be disposed on the control handle 20 for fixing the end of the front section 81 of the adhering wire 8 and the end of the rear section 82, or two control members may be provided for respectively fixing the front section of the adhering wire 8
  • the ends of the 81 and the ends of the rear section 82 enable separate control of the front section 81 and the rear section 82 of the walling adjustment wire 8.
  • the front section 81 of the wall-adjusting wire 8 is used to control the diameter expansion of one or more spiral segments of the electrode holder between the hole 11 and the fixed point 13, and the rear section 82 of the wall-adjusting wire 8 is used to control the electrode holder to be located in the hole.
  • the diameter of one or more turns of the spiral section between 12 and the fixed point 13 is expanded. As shown in FIGS.
  • the diameter ⁇ B for better adhesion effect, and more than one turn of the spiral segment will become a new spiral shape, the diameter also exceeds the initial diameter ⁇ B of the spiral shape of the electrode holder, and the diameter expansion occurs, thereby obtaining a larger The anchoring diameter and better anchoring effect.
  • the control of the front section 81 and the rear section 82 of the wall-adjusting wire can be separately controlled by two single control members connected thereto, thereby achieving separate adjustment of the diameters of different parts on the electrode holder, or by the same control member. Control is performed to achieve control of the diameter expansion of the plurality of spiral segments of the electrode holder as a whole. Moreover, when the end of the front wall adjusting wire 81 and the end of the rear portion 82 are respectively fixed on different control members, different portions of the electrode holder can also be made by simultaneously pulling the front portion 81 and the rear portion 82 of the fitting adjusting wire. At the same time, the diameter is adjusted to achieve the axial contraction of the entire electrode holder so as to achieve the axial contraction effect as shown in Fig.
  • the diameter of the spiral after the diameter expansion can reach the effect as shown in Fig. 34B. Since the front section 81 and the rear section 82 of the fitting adjustment wire 8 can respectively control the electrode holder to be positioned between the hole 12 and the fixed point 13, and the diameter of one or more spiral segments between the hole 11 and the fixed point 13 is expanded.
  • the expanded diameter is made equal to or even larger than the original diameter as shown in Fig. 32B, so that a better adhering effect can be obtained, and a target lumen having a larger range of diameter variations can be achieved.
  • the adhering regulating wire 8 disposed inside the radio frequency ablation catheter is composed of a plurality of wires, wherein the front end of each wire is fixed on the electrode holder, and the rear end bypasses a spiral segment of the electrode holder from the outside.
  • the corresponding control member of 20 is fixed on the corresponding control member of the peripheral device after passing through the control handle 20, and the plurality of wires are respectively used for independently controlling the diameters of different spiral segments of the electrode holder.
  • the adhering wire 8 is composed of two wires 84 and 85, the front ends of which are fixed at a certain point of the electrode holder to form a fixing point 83, and the rear ends respectively bypass the different spirals of the electrode holder
  • the segment enters the interior of the electrode holder or catheter body and returns to the rear end via the electrode holder and the lumen inside the catheter body and is secured to a corresponding control member in the control handle 20.
  • the structure of the two-filament anchoring wire 8 is substantially the same as that of the seventh embodiment, and can be used to separately control the diameter expansion of the front and rear spiral segments of the electrode holder.
  • the structure in the seventh embodiment can be directly understood as the case where the adhering wire 8 is made of two wires in the eighth embodiment.
  • the front end of each wire is fixed on the electrode holder, the portion near the front end (ie, near the fixed point) is exposed outside the electrode holder, and the rear end is disposed on the electrode holder.
  • the holes at different positions enter the inside of the electrode holder and are returned to the control handle 20 via the electrode holder and the same lumen or different lumen inside the catheter body, and are fixed to the corresponding control members.
  • the fixing points of the plurality of wires on the electrode holder may be the same, may be different, or may not be identical.
  • each of the two wires may have a common fixing point on the electrode holder, and the structure of the two wires may be referred to the structure shown in FIG.
  • the fixing points of the plurality of wires on the electrode holder are the same, the front ends of the different wires can be fixed on the front end A of the electrode holder as shown in Fig. 36A, and then the rear ends of the respective wires are respectively separated from the different holes on the electrode holder.
  • the hole enters the inside of the electrode holder and passes through the electrode holder and the catheter tube body from the end of the catheter tube body, and the ends E' of the plurality of wires are respectively fixed on the corresponding control members disposed on the control handle 20 or the corresponding control members of the peripheral device.
  • Each strand enters the interior of the electrode holder from a different location on the electrode holder so that the diameter of the helix of the helix between the fixed point of the leading end of the filament and the position of the filament entering the electrode holder can be controlled by pulling a single wire.
  • the plurality of wires can also be fixed on the same control member of the control handle 20, thereby realizing the entire electrode holder. Diameter adjustment.
  • the corresponding spiral segment of the electrode holder can be segmentally expanded as needed, that is, only the spiral segment requiring radio frequency is expanded. Therefore, the flexibility of adjusting the diameter of different spiral segments of the electrode holder is increased, and the difficulty of adjusting the wall of the radiofrequency ablation catheter is reduced.
  • the spiral ablation catheter is provided with an adherent adjustment wire, and by pulling the attachment adjustment wire backward, the spiral diameter of the electrode holder can be changed, thereby improving the electrode attachment state and enabling the radiofrequency ablation.
  • the catheter is suitable for blood vessels of different diameters.
  • the above-mentioned adherent regulating wire can also adopt a structure of multi-strand wire, thereby realizing separate control of different spiral segments of the radio frequency ablation catheter, and simplifying the difficulty of diameter adjustment.
  • the radiofrequency ablation catheter and the radiofrequency ablation device provided by the invention can be applied to nerve ablation of different parts, blood vessels or trachea of different diameters.
  • it is applied to renal artery ablation for the treatment of patients with refractory hypertension. It is used in the treatment of diabetic patients with intra-abdominal artery ablation.
  • it is applied to the treatment of asthma patients with tracheal/bronchial vagal branch ablation, and for duodenal vagus nerve.
  • the radiofrequency ablation catheter provided by the present invention is not limited to the above enumerated applications in clinical treatment, and can also be used for nerve ablation in other parts.
  • the helical ablation catheter provided by the present invention is described above.
  • the present invention also provides a radiofrequency ablation device including the radiofrequency ablation catheter described above.
  • the radiofrequency ablation device includes a radio frequency ablation catheter coupled to the radio frequency ablation catheter, in addition to the radio frequency ablation catheter.
  • the support wall fixing wire (and its bifurcation adjusting wire) or the adhering adjusting wire inside the electrode holder is connected to the control handle through the catheter tube body, and the electrode holder can be changed by pulling the support wall adjusting wire through the control handle.
  • the shape is convenient for entering the target lumen, and the wall is well adhered in the target lumen; the shape of the electrode holder can be changed by pulling the adjustment wire through the control handle, so that the electrode holder is well adhered in the target lumen of different diameters.
  • the radio frequency wires and the thermocouple wires in the electrode holder are respectively connected to corresponding circuits in the radio frequency ablation host through the catheter tube body, thereby realizing radio frequency control and temperature monitoring of the plurality of electrodes by the radio frequency ablation host. Since the setting of the control handle and the setting of the radio frequency ablation host can be referred to the prior patent application disclosed by the applicant, the specific structure is not used here. A detailed description.

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PCT/CN2016/073378 2015-02-03 2016-02-03 一种螺旋结构的射频消融导管及其设备 Ceased WO2016124138A1 (zh)

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ES16746133T ES2955930T3 (es) 2015-02-03 2016-02-03 Catéter de ablación por radiofrecuencia con estructura en espiral y equipos del mismo
US15/548,672 US10646272B2 (en) 2015-02-03 2016-02-03 Radio-frequency ablation catheter having spiral structure and device thereof
EP18162451.1A EP3360497B1 (en) 2015-02-03 2016-02-03 Radio-frequency ablation catheter having spiral structure and device thereof
JP2017558612A JP6716607B2 (ja) 2015-02-03 2016-02-03 螺旋構造の高周波アブレーションカテーテル及びその機器
EP16746133.4A EP3254635B1 (en) 2015-02-03 2016-02-03 Radio-frequency ablation catheter having spiral structure, and equipment thereof

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CN201510057095.5A CN104605930A (zh) 2014-12-29 2015-02-03 一种螺旋结构的射频消融导管及其设备
CN201510129947.7 2015-03-23
CN201510129947.7A CN104688334A (zh) 2015-03-23 2015-03-23 具有贴壁调节丝的螺旋型射频消融导管及其设备
CN201520434410.7U CN204971568U (zh) 2015-06-19 2015-06-19 一种螺旋结构的射频消融导管及其设备
CN201520434410.7 2015-06-19
CN201510349237.5 2015-06-19
CN201520433569.7U CN204734547U (zh) 2015-03-23 2015-06-19 具有贴壁调节丝的螺旋型射频消融导管及其设备
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CN201510349237.5A CN105193497B (zh) 2014-12-29 2015-06-19 一种螺旋结构的射频消融导管及其设备
CN201510350172.6A CN104939918B (zh) 2015-03-23 2015-06-19 具有贴壁调节丝的螺旋型射频消融导管及其设备

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