WO2019141284A1 - 一种环形标测导管 - Google Patents

一种环形标测导管 Download PDF

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Publication number
WO2019141284A1
WO2019141284A1 PCT/CN2019/072634 CN2019072634W WO2019141284A1 WO 2019141284 A1 WO2019141284 A1 WO 2019141284A1 CN 2019072634 W CN2019072634 W CN 2019072634W WO 2019141284 A1 WO2019141284 A1 WO 2019141284A1
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Prior art keywords
annular
distal end
catheter
electrodes
annular portion
Prior art date
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Ceased
Application number
PCT/CN2019/072634
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English (en)
French (fr)
Chinese (zh)
Inventor
冯骥
龚杰
王利荣
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Synaptic Medical Beijing Co Ltd
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Synaptic Medical Beijing Co Ltd
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Filing date
Publication date
Application filed by Synaptic Medical Beijing Co Ltd filed Critical Synaptic Medical Beijing Co Ltd
Priority to CN201980009334.6A priority Critical patent/CN111629678B/zh
Priority to US16/963,804 priority patent/US11872057B2/en
Priority to EP19740717.4A priority patent/EP3744275B1/en
Priority to JP2020560536A priority patent/JP7254096B2/ja
Publication of WO2019141284A1 publication Critical patent/WO2019141284A1/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
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6853—Catheters with a balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6856—Catheters with a distal loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6876—Blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00039—Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
    • A61B2017/00044—Sensing electrocardiography, i.e. ECG
    • A61B2017/00048—Spectral analysis
    • A61B2017/00053—Mapping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00331—Steering mechanisms with preformed bends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61B2018/00059—Material properties
    • 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
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00375—Ostium, e.g. ostium of pulmonary vein or artery
    • 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
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
    • 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
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter

Definitions

  • the present invention relates to an annular mapping catheter for mapping a pulmonary vein ostium during an ablation procedure.
  • Atrial fibrillation is one of the most common forms of tachyarrhythmia in the clinic.
  • ablation strategies that implement circumferential pulmonary vein ablation and achieve pulmonary vein electrical isolation as the end point have been accepted by various electrophysiological centers, becoming the main and cornerstone surgery.
  • Catheter ablation is currently the most widely used method in China and internationally.
  • Catheter ablation is divided into two categories based on ablation energy: radiofrequency ablation and cryoablation. The two aim to block the myocardial tissue or bypass that interferes with normal ECG activity and restore normal ECG conduction. The difference is that the former is degeneration and necrosis of the target cells by electrocautery, while the latter is a large amount of tissue extracted by evaporation of the cryogen. Heat, rapid cooling to achieve ablation.
  • An intracardiac circular mapping catheter for use with a cryoablation catheter reaches a pulmonary vein port through a dedicated passage provided by a cryoablation catheter for detecting electrocardiographic activity at the pulmonary vein ostium. Due to the limitation of the structure of the head end, the widely used intracardiac ring mapping catheter cannot map the ECG activity of the ablation point more closely, and it is not convenient to determine the position of the catheter in the heart, thereby increasing to some extent. The complexity of the diagnosis.
  • the invention provides an annular mapping catheter, wherein the annular mapping catheter comprises a catheter body; the catheter body has a distal end and a proximal end, and a distal end component is disposed at a distal end of the catheter body, The proximal end of the catheter body is provided with a handle; wherein the distal end assembly is constituted by a head end tube having a shape memory function, and in a free state, the distal end assembly presents a predetermined curved shape including an annular portion and a vertical portion, The vertical portion connects the annular portion to the catheter body; and the distal assembly is provided with an electrode.
  • the head end tube comprises a shape memory material.
  • the shape memory material is a wire made of a shape memory material.
  • the wire extends within the predetermined curved portion, the proximal end of the wire being fixed to the catheter body.
  • the head end tube comprises a flexible tube body, the shape memory material is disposed in the flexible tube body, and the electrode is disposed outside the flexible tube body.
  • the predetermined bend is formed in a free state, the vertical portion extending at least partially distally beyond the annular portion.
  • the annular mapping catheter is adapted for use with a frozen balloon catheter.
  • the distal assembly is pushed to extend through the body of the frozen balloon catheter to the distal end of the balloon and extends from the aperture at the distal end of the balloon section.
  • the distal assembly when the distal assembly is continuously pushed, the distal assembly extends out of the aperture at the distal end of the balloon and flips into the predetermined bend.
  • the annular portion abuts the position of the effective ablation ring of the balloon after the distal assembly is turned into the predetermined shape.
  • the straight line of the vertical portion is perpendicular or substantially perpendicular to a plane formed by the annular portion.
  • the straight line passes through the center of the annular portion.
  • the frozen balloon catheter is pushed further such that the annular portion is indexed against the pulmonary vein ostium.
  • two sets of electrodes are distributed on the distal component.
  • the annular portion of the distal assembly is provided with a set of electrodes, and the vertical portion of the distal assembly is provided with another set of electrodes.
  • the electrode on the vertical portion cooperates with the electrode on the annular portion to position the balloon.
  • the electrodes on the annular portion are used to map the pulmonary vein ostium.
  • the vertical portion is provided with at least two electrodes.
  • the annular portion is provided with a plurality of electrodes that are evenly distributed.
  • At least two electrodes on the vertical portion form a straight line, and the electrodes on the annular portion constitute a plane; the vertical portion
  • the line formed by the at least two electrodes on the upper side is perpendicular or substantially perpendicular to the plane formed by the electrodes on the annular portion.
  • a straight line formed by at least two electrodes on the vertical portion passes through a center of the annular portion.
  • the distance between the at least two electrodes on the vertical portion and the electrodes on the annular portion is fixed.
  • a developing mark is provided at the most distal end of the predetermined curved shape.
  • a cryoablation device comprising: an annular mapping catheter comprising a catheter body; the catheter body having a distal end and a proximal end, the distal end of the catheter body being provided with a distal end assembly, a proximal end of the catheter body is provided with a handle; wherein the distal end assembly is formed by a head end tube having a shape memory function, the distal end assembly exhibiting a predetermined shape including an annular portion and a vertical portion in a free state, A vertical portion connects the annular portion to the catheter body; and the distal assembly is provided with an electrode; and a frozen balloon catheter adapted for use with a frozen balloon catheter.
  • the predetermined bend is formed in a free state, the vertical portion extends at least partially distally beyond the annular portion; the distal assembly is pushed to pass through the tube of the frozen balloon catheter
  • the body extends to the distal end of the balloon and extends from the aperture at the distal end of the balloon out of the annular portion.
  • the distal end assembly when the distal end assembly is continuously pushed, the distal end assembly extends out of the hole at the distal end of the balloon and is turned into the predetermined shape, the annular portion abutting the balloon Effectively ablate the position of the ring.
  • the straight line of the vertical portion is perpendicular or substantially perpendicular to a plane formed by the annular portion.
  • the straight line passes through the center of the annular portion.
  • the annular portion of the distal end assembly is provided with a set of electrodes
  • the vertical portion of the distal end assembly is provided with another set of electrodes; the electrodes on the vertical portion and the annular portion The electrode fit positions the position of the balloon.
  • the vertical portion is provided with at least two electrodes
  • the annular portion is provided with a plurality of electrodes uniformly distributed.
  • At least two electrodes on the vertical portion form a straight line, and the electrodes on the annular portion constitute a plane; the vertical portion
  • the line formed by the at least two electrodes on the upper side is perpendicular or substantially perpendicular to the plane formed by the electrodes on the annular portion.
  • a straight line formed by at least two electrodes on the vertical portion passes through a center of the annular portion.
  • the distance between the at least two electrodes on the vertical portion and the electrodes on the annular portion is fixed.
  • a developing mark is provided at the most distal end of the predetermined curved shape.
  • the annular mapping catheter can detect both ECG activity at the proximal pulmonary vein ostium and better position the frozen balloon within the heart.
  • FIG. 1 is a schematic structural view of a circular mapping catheter according to an embodiment of the present invention.
  • Figure 2 is a schematic view showing the distal end of the annular mapping catheter
  • Figure 3 is an enlarged view of the portion H of Figure 2;
  • FIG. 4 is a schematic view showing the use of a circular mapping catheter in accordance with an embodiment of the present invention in conjunction with a frozen balloon catheter;
  • Figure 5 is a schematic illustration of a variant embodiment of the embodiment shown in Figure 4.
  • FIG. 1 is a schematic block diagram of an annular mapping catheter 10 in accordance with an embodiment of the present invention, including a catheter body 12 having a distal end and a proximal end, and a distal end at the distal end of the catheter body 12 Component 13.
  • the catheter body 12 can be made of a metallic material, such as stainless steel, that can enhance the support of the tubular body. But other suitable materials are also feasible.
  • a handle 14 is provided at the proximal end of the catheter body 12, which facilitates operation of the annular mapping catheter 10 and can serve as a catheter connector for the catheter body 12.
  • a guide tube 15 may also be sheathed at the proximal end portion of the catheter body 12. The guide tube 15 is adapted to guide the annular mapping catheter 10 into the cryo balloon catheter 20.
  • FIG. 2 is a schematic view showing the structure of the distal end assembly 13 of the annular mapping catheter 10, and FIG. 3 is an enlarged view of the portion H of FIG.
  • the distal end assembly 13 can be formed by a head end tube 31, for example, the distal end assembly 13 is formed by rotation of a head end tube 31 having a predetermined curvature, wherein the predetermined shape can include a ring shape Part 34 and vertical portion 35.
  • the proximal end of the head end tube 31 can be secured to the catheter body 12 by any suitable means, such as by bonding. According to a preferred embodiment of the invention, as shown in Fig. 2 or Fig.
  • the predetermined bend is shaped such that, in the free state, the vertical portion extends at least partially distally beyond the annular portion. That is, as described below, when the predetermined curved shape of the distal end assembly 13 extends through the tubular body of the frozen balloon catheter with which it is engaged, the annular portion 34 can be flipped rearward from the vertical portion 35, after being turned over The position of the effective ablation ring on the balloon of the frozen balloon catheter.
  • the effective ablation ring may refer to a circle B of low cooling temperature on the surface of the balloon, or a circle C of contact between the distal end of the balloon and the myocardial tissue when the balloon abuts the pulmonary vein, or the distal component 13 After the flip is turned into a predetermined shape, the annular portion 34 is in contact with the balloon a circle D.
  • Circle B, circle C, and circle D may be coincident or substantially coincident.
  • the vertical portion 35 is the portion that connects the annular portion 34 to the catheter body 12. As can be seen from the figures, the vertical portion 35 can include a generally straight portion that is coupled to the catheter body 12 and a curved portion that is coupled to the annular portion that is generally vertically oriented relative to the annular portion 35 in a free state.
  • the annular portion 34 is annular, and the person skilled in the art can also set it to be substantially annular as needed, and can achieve the same technical effect without departing from the spirit of the present invention.
  • the annular portion 34 can also be a polygonal structure.
  • the central axis of the annular portion 34 may be in line with the axis of the proximal portion of the head end tube 31, or may be offset from the axis of the proximal portion of the head end tube 31.
  • the head end tube 31 can include a tubular body and an internal shape memory material and thus has a shape memory function.
  • the tubular body can be made of a biocompatible material and includes a distal end, a proximal end, and a central chamber.
  • the tubular body is generally flexible and the shape memory material extends within the central chamber of the tubular body such that the head end tube 31 also has a shape memory function.
  • the wire 32 extends within the central chamber of the body of the head end tube 31.
  • the wire 32 can be made of a shape memory material such as a nickel titanium alloy.
  • the distal end of the wire 32 extends to the distal end of the head end tube 31 and is fixed, as may be fixed by bonding.
  • the proximal end of the wire 32 is secured to the catheter body 12, such as by bonding or welding. Since the wire 32 is fixedly coupled to the body of the head end tube 31, the head end tube 31 has the same memory function as the wire 32.
  • the shape of the tube of the head end tube 31 is changed, the original shape can be restored in a short time, and the wire 32 can also provide good support performance to the tube body of the head end tube 31.
  • the wire 32 is secured to the body of the head end tube 31 over its entire length to provide the head end tube 31 with a better shape memory function.
  • the head end tube 31 can also have a good shape memory function due to the tight fit between the wire and the flexible tube body without the need for additional securing means.
  • the wire 32 extends along the entire predetermined curved portion.
  • the shape of the wire 32 is not limited as long as it can be engaged with the body of the head end tube 31 so that the head end tube 31 has a shape memory function.
  • the distal end assembly 13 assumes a predetermined curvature including the annular portion 34 and the vertical portion 35 in the free state.
  • the vertical portion 35 connects the annular portion to the catheter body 12.
  • the distal end assembly 13 is further provided with an electrode 33, and the number of the electrodes 33 can be determined according to actual needs.
  • the electrode 33 can transmit both signals and positioning.
  • the distal end assembly 13 is distributed with two sets of electrodes, which are respectively disposed on the annular portion 34 and the vertical portion 35.
  • the number of electrodes on the annular portion 34 may be determined according to actual needs, and the electrodes 33 may be evenly distributed, or the electrode spacing may be determined as needed.
  • the annular portion 34 is provided with a plurality of evenly distributed electrodes.
  • the vertical portion 35 is provided with at least two electrodes, which can be used for positioning the balloon, and can also be used for mapping, as described below. The position and configuration of the annular portion 34 and the vertical portion 35 can be determined by the electrodes on the three-dimensional detector when the relevant surgical procedure is performed.
  • the distal end of the lead extends through the central chamber of the catheter body 12 into the chamber of the head tube 31 to be electrically coupled to the electrode 33.
  • the proximal end of the wire is secured to the handle 14, and the method of attachment can be secured by any suitable method known to those skilled in the art, such as by welding to a corresponding plug.
  • the signal measured by the electrode 33 can be obtained by the plug for the corresponding analysis.
  • FIG. 4 is a schematic illustration of a circular mapping catheter 10 for use with a frozen balloon catheter 20 for guiding an annular mapping catheter 10, in accordance with an embodiment of the present invention.
  • the distal end assembly 13 extends through the body of the frozen balloon catheter 20 to the balloon 21, contracting within the balloon 21.
  • the annular portion 34 is reduced to a ring structure due to the shape memory function.
  • a preliminary mapping of the pulmonary vein opening can be performed to diagnose whether the tissue is a focal point.
  • a in Figure 4 is still within the balloon.
  • the frozen balloon catheter 20 is then subjected to cryoablation of the tissue.
  • the cryo-balloon catheter 20 can be withdrawn into the left atrium and the distal assembly 13 can be pushed from the bore 22 at the distal end of the balloon 21, as depicted at point A in Figure 4. Extends in the balloon.
  • the curved shape of the distal end member 13 is reversed from the initial annular structure to a predetermined curved shape, that is, a predetermined curved shape including the annular portion 34 and the vertical portion 35.
  • the distal assembly 13 is withdrawn such that the annular portion 34 abuts the position of the effective ablation ring of the balloon 21, ie, the lowest temperature position on the frozen balloon.
  • the frozen balloon catheter 20 is pushed forward so that the annular portion 34 abuts against the pulmonary vein ostium, and the tissue on the annular portion 34 can be indexed to determine whether the ablation is successful.
  • the engagement of the electrode 33 on the vertical portion 35 with the electrode on the annular portion 34 also positions the position of the balloon 21.
  • at least two electrodes on the vertical portion 35 form a straight line, and the straight line may be associated with the catheter 10
  • the axes are in a straight line or substantially in a straight line.
  • the electrodes on the annular portion 34 form a plane.
  • a line formed by at least two electrodes on the vertical portion 35 is perpendicular or substantially perpendicular to a plane formed by the electrodes on the annular portion 34, and the straight line passes through the center of the annular portion 34 or substantially passes through The center of the annular portion 34 is described.
  • the distance between the two electrodes on the vertical portion 35 and the electrodes on the annular portion 34 is fixed. Therefore, the height, length, and angle of the geometry formed by the line between the two electrodes on the vertical portion 35 and the upper electrode of the annular portion 34 are fixed, and in operation, in a three-dimensional system. The shape and position of the geometry can be confirmed. While the annular portion 34 is located at the position of the effective ablation ring of the balloon 21, the position of the balloon can be positioned in a three dimensional system.
  • the straight line at which the vertical portion 35 is located is perpendicular or substantially perpendicular to the plane formed by the annular portion 34, And the straight line passes through the center of the annular portion 34 or substantially through the center of the annular portion 34.
  • the distal assembly 13 in operation, can be pushed to extend through the tubular body of the frozen balloon catheter 20 to the distal end of the balloon, and from the A hole at the distal end of the balloon extends out of the annular portion 34.
  • the distal assembly When the distal assembly is continuously pushed, the distal assembly 13 extends out of the aperture at the distal end of the balloon and flips into the predetermined bend.
  • the annular portion 34 abuts the position of the effective ablation ring of the balloon after the distal assembly 13 is flipped into the predetermined shape.
  • the frozen balloon catheter can be pushed forward such that the annular portion 34 abuts against the pulmonary vein ostium, and the tissue on the annular portion 34 can be indexed to determine whether the ablation is successful.
  • Figure 5 is a variation of the embodiment of Figure 4, with the exception of the addition of the development mark 36, which is otherwise consistent with Figure 4.
  • a development mark 36 is provided at the most distal or substantially distal end of the predetermined curved shape, and the development mark 36 may be a developing ring. Or other suitable structure.
  • the development marker 36 is positioned such that the distal end of the annular mapping catheter 10 can display the position of the distal end of the catheter in real time during delivery into the pulmonary vein ostium and can indicate whether the distal end of the catheter reaches the pulmonary vein ostium.
  • it can also be judged whether the curvature of the distal end assembly 13 is reversed from the initial annular structure to a predetermined curved shape.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Otolaryngology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Surgical Instruments (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
PCT/CN2019/072634 2018-01-22 2019-01-22 一种环形标测导管 Ceased WO2019141284A1 (zh)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CN201980009334.6A CN111629678B (zh) 2018-01-22 2019-01-22 一种环形标测导管
US16/963,804 US11872057B2 (en) 2018-01-22 2019-01-22 Annular mapping catheter
EP19740717.4A EP3744275B1 (en) 2018-01-22 2019-01-22 Annular mapping catheter
JP2020560536A JP7254096B2 (ja) 2018-01-22 2019-01-22 環状マッピングカテーテル

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201810058930.0 2018-01-22
CN201810058930.0A CN110063784A (zh) 2018-01-22 2018-01-22 一种环形标测导管

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CN110063784A (zh) 2019-07-30
EP3744275B1 (en) 2024-03-13
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