WO2021201101A1 - バルーン付きアブレーションカテーテルシステム及びその制御方法 - Google Patents

バルーン付きアブレーションカテーテルシステム及びその制御方法 Download PDF

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WO2021201101A1
WO2021201101A1 PCT/JP2021/013837 JP2021013837W WO2021201101A1 WO 2021201101 A1 WO2021201101 A1 WO 2021201101A1 JP 2021013837 W JP2021013837 W JP 2021013837W WO 2021201101 A1 WO2021201101 A1 WO 2021201101A1
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Prior art keywords
balloon
cauterization
pressure
heating
volume
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English (en)
French (fr)
Japanese (ja)
Inventor
塚本康太
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Toray Industries Inc
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Toray Industries Inc
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Priority to US17/915,052 priority Critical patent/US12256973B2/en
Priority to EP21779546.7A priority patent/EP4129223A4/en
Priority to JP2021519186A priority patent/JPWO2021201101A1/ja
Priority to CN202180025227.XA priority patent/CN115279291A/zh
Priority to KR1020227026876A priority patent/KR20220159353A/ko
Publication of WO2021201101A1 publication Critical patent/WO2021201101A1/ja
Anticipated expiration legal-status Critical
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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
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082—Probes or electrodes therefor
    • 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
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • 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
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/10—Power sources therefor
    • 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
    • A61B18/1206—Generators therefor
    • 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
    • A61B2017/00199—Electrical control of surgical instruments with a console, e.g. a control panel with a display
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • 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
    • A61B2018/00595—Cauterization
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    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A61B2018/00648—Sensing and controlling the application of energy with feedback, i.e. closed loop control using more than one sensed parameter
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    • A61B2018/00684—Sensing and controlling the application of energy using lookup tables
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    • A61B2018/00696—Controlled or regulated parameters
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    • A61B2018/00714—Temperature
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/063—Measuring instruments not otherwise provided for for measuring volume
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension

Definitions

  • the present invention relates to an ablation catheter system with a balloon capable of estimating the cauterization depth at the time of ablation and a control method thereof.
  • Catheter ablation treatment is a method in which an ablation catheter is inserted into the heart chamber of the heart, and the myocardial tissue that causes arrhythmia or the like is destroyed by a method such as ablation to perform treatment.
  • Catheter ablation is primarily used to treat tachyarrhythmias such as paroxysmal supraventricular tachycardia, atrial tachycardia, atrial flutter and paroxysmal ventricular tachycardia, and is used on cardiac electrophysiological examinations for arrhythmias.
  • this is a treatment method in which an ablation catheter is made to reach the site of occurrence of arrhythmia from within the cardiac cavity, and the target site is destroyed by a method such as heating the tip of the catheter.
  • ablation catheters for use in this treatment method.
  • a metal electrode having a length of 4 mm to 8 mm and a diameter of 2 mm to 3 mm is provided at the tip of the catheter, and the metal electrode portion is provided.
  • Ablation catheters that make point-like contact with the myocardial tissue that causes arrhythmia to isolate the source of arrhythmia, and ablation catheters with balloons that can heat the balloon in the atrium while attaching a balloon to the tip of the catheter. are known.
  • the cauterization depth of the myocardial tissue in contact with the balloon can be accurately determined. It is required to estimate.
  • Patent Document 1 has a metal electrode at the tip of a catheter, measures the force applied to the target tissue, and integrates the force with the energization time of the ablation probe to estimate the lesion size (depth, volume). Or an area) can be supplied in real time.
  • Patent Documents 2 and 3 report an ablation catheter system with a balloon having a balloon at the tip of the catheter tube, which is provided with a high frequency generator and a balloon surface temperature equalizing device.
  • JP-A-2010-259810 Japanese Patent Application Laid-Open No. 2003-102850 JP 2010-240004
  • Patent Documents 2 and 3 report high-frequency heating balloon catheters that can heat the tissue in contact with the balloon as uniformly as possible with high-frequency heating and safely heat-treat the affected area at the optimum temperature.
  • An example is shown in which the cauterization depth of the tissue is proportional to the balloon contact temperature and the high-frequency energization time.
  • the cauterization depth differs depending on the contact state between the balloon and the tissue, and the cauterization is sufficiently performed. There is a possibility that it will not be damaged.
  • An ablation catheter system comprising a processor that calculates an estimated causal depth with the obtained balloon volume value as a variable.
  • D k * P 2 + k'* P + t ⁇ ⁇ ⁇ Equation 1
  • D represents the estimated cauterization depth
  • k and k'are based on the balloon volume and the proportionality constant referenced from the reference table based on the heating temperature and cauterizing time
  • t is based on the balloon volume and the heating temperature and cauterizing time. It is a constant referenced from the reference table, where P represents the value of the balloon pressure.
  • P represents the value of the balloon pressure.
  • the processor outputs the heating temperature and the cauterization time required to obtain a set estimated cauterization depth with respect to the obtained values of the balloon pressure and the balloon volume, (1) to The ablation catheter system according to any one of (5).
  • (7) Based on the steps of measuring the pressure of the balloon, the step of measuring the volume of the balloon, the heating temperature of the generator, the ablation time of the generator, the pressure of the balloon and the volume of the balloon, the ablation depth is determined.
  • a method of controlling an ablation system including an estimation process.
  • the cauterization depth of ablation can be estimated from the settings of the balloon pressure, the balloon volume, the heating temperature and the cauterization time, so that the affected area can be reliably cauterized. Can be done.
  • FIG. 6 is a cross-sectional view taken along the line CC'of the balloon catheter shown in FIG. The flowchart regarding the control of the ablation catheter system with a balloon of this invention is shown.
  • the flowchart of the procedure concerning the control of the ablation catheter system with a balloon of this invention is shown. It is the schematic which showed the evaluation system for measuring the cauterization depth by a balloon catheter. It is a graph which shows the relationship between the internal pressure of a balloon and the cauterization depth. It is an enlarged schematic view of the cauterized part of the evaluation system of FIG. It is a graph which shows the relationship between the contact pressure of a balloon and the cauterization depth.
  • the ablation catheter system of the present invention includes a catheter shaft, a balloon attached to the catheter shaft, a lumen that penetrates the catheter shaft in the longitudinal direction and communicates with the inside of the balloon, and heating arranged inside the balloon.
  • the electrode and temperature sensor, the heating device that applies electrical energy to the heating electrode, the pressure sensor, the balloon volume sensor, the heating temperature of the generator, the cauterizing time of the generator, the value of the balloon pressure obtained from the pressure sensor, and the value of the balloon pressure obtained from the pressure sensor. It is characterized by including a processor that calculates an estimated causal depth using the value of the balloon volume obtained from the balloon volume sensor as a variable.
  • the “cauterization depth” refers to the vertical distance (mm) from the outermost surface of the ablation target tissue to which the balloon contacts to the deepest surface of the target tissue in which irreversible degeneration has occurred.
  • the "balloon pressure” used in the present specification refers to the “balloon internal pressure” applied to the inside of the balloon or the “balloon contact pressure” which is the pressure generated when the balloon is pressed against the tissue to be ablated.
  • the ablation catheter 1 with a balloon according to the first embodiment of the present invention will be described with reference to FIG.
  • the ablation catheter system 15 with a balloon shown in FIG. 1 is roughly divided into an ablation catheter 1 with a balloon, a pressure measuring unit including a pressure sensor 6 for measuring balloon pressure and a pressure measuring unit 18, a balloon volume sensor 16 and a syringe 19. It is composed of a liquid adjusting unit including the vibration applying device 25 and a heating device 13 for supplying power to the heating electrode 9.
  • the ablation catheter 1 with a balloon is provided with a balloon 3 capable of expanding and contracting on the distal end side of the catheter shaft 2a, and the distal end and the posterior end of the balloon 3 are fixed to the catheter shaft 2a.
  • the catheter shaft 2a has a lumen 4 penetrating the inside of the catheter shaft 2a, and the lumen 4 communicates with the inside of the balloon 3 by a side hole 5 provided inside the balloon 3 at the tip end portion of the catheter shaft 2a.
  • the lumen 4 on the proximal end side of the catheter shaft 2a is connected to the balloon volume sensor 16 via a three-way stopcock 29, and the balloon volume sensor 16 is connected to the vibration imparting device 25 via an extension tube 28.
  • the heating electrode 9 is fixed to the catheter shaft 2a inside the balloon 3, and the temperature sensor 10 is fixed to the base end of the heating electrode 9.
  • the lead wire 11 for the heating electrode connected to the heating electrode 9 and the lead wire 12 for the temperature sensor connected to the temperature sensor 10 are connected to the heating device 13 through the lumen 4.
  • the pressure sensor 6 is connected to the pressure sensor lead wire 17 and is connected to the pressure measuring unit 18.
  • the pressure sensor 6 is preferably installed on the surface of the balloon 3, inside the balloon 3, or inside the lumen 4. In the balloon-equipped ablation catheter 1 according to the first embodiment of FIG. 1, the pressure sensor 6 is installed inside the balloon 3 and inside the lumen 4.
  • the length of the catheter shaft 2a is preferably 0.5 m to 2 m.
  • the diameter of the catheter shaft 2a is preferably 3 m to 5 mm.
  • the material of the catheter shaft 2a is preferably a flexible material having excellent antithrombotic properties.
  • the flexible material having excellent antithrombotic properties include, but are not limited to, fluoropolymers, polyamides, polyurethane-based polymers, and polyimides.
  • the shape of the balloon 3 may be any shape that can fit the blood vessel.
  • the size that fits the pulmonary vein junction of the left atrium is preferably a spherical shape having a diameter of 15 mm to 40 mm. ..
  • the spherical shape includes a true spherical shape, an oblate spherical shape, and a long spherical shape, but a true spherical balloon is preferable. Further, these spherical shapes include those having a substantially spherical shape.
  • the film thickness of the balloon 3 is preferably 20 ⁇ m to 100 ⁇ m.
  • the material of the balloon 3 is preferably a stretchable material having excellent antithrombotic properties, and more preferably a polyurethane-based polymer material.
  • the polyurethane-based polymer material include thermoplastic polyether urethane, polyether polyurethane urea, fluorine polyether urethane urea, polyether polyurethane urea resin, and polyether polyurethane urea amide.
  • the lead wire 11 for the heating electrode, the lead wire 12 for the temperature sensor, and the lead wire 17 for the pressure sensor are inserted into the lumen of the catheter shaft 2a.
  • the structure is such that the heating liquid 14 passes through the gap between the inside of the lumen and each lead wire.
  • a lumen 4a through which the heating liquid 14 communicating with the inside of the balloon 3 passes, a lead wire 11 for a heating electrode, and a lead wire 12 for a temperature sensor It may have a structure such as a double lumen catheter shaft 2b having a lumen 4b through which the pressure sensor lead wire 17 is inserted.
  • the measurement method of the pressure sensor 6 includes, but is not limited to, a resistance wire type and a capacitance type.
  • the catheter shaft may be a double-tube type catheter shaft 2c in which the inner tube 20 is inserted into the lumen of the outer tube 21.
  • the structure of the catheter shaft 2c is such that the space between the outer tube 21 and the inner tube 20 communicates with the inside of the balloon 3 as shown in FIG.
  • the pressure sensor 6 is arranged on the surface of the balloon 3, the inside of the balloon 3, or the lumen 4, and the lead wire 11 for the heating electrode and the lead wire 12 for the temperature sensor are inserted through the lumen of the inner tube 20. ..
  • the space between the outer tube 21 and the inner tube 20 communicates with the inside of the balloon 3.
  • the pressure sensor 6 is arranged on the surface of the balloon 3, the inside of the balloon 3, or the space between the outer tube 21 and the inner tube 20, and is used for the heating electrode in the space between the outer tube 21 and the inner tube 20. It is preferable that the lead wire 11, the lead wire 12 for the temperature sensor, and the lead wire 17 for the pressure sensor are inserted, and the guide wire 23 is inserted through the central lumen 22 of the inner pipe 20.
  • the tip of the balloon 3 is fixed to the tip of the inner tube 20 in the longitudinal direction, and the rear end of the balloon 3 is the outer tube 21. It is preferable that the balloon is fixed to the tip portion in the longitudinal direction of the balloon.
  • the shape of the heating electrode 9 is preferably a tubular shape such as a coil shape or a cylindrical shape having a length of 10 mm to 20 mm.
  • the diameter of the electric wire of the coiled heating electrode 9 is preferably 0.1 mm to 1 mm.
  • Examples of the material of the heating electrode 9 include gold, silver, platinum or copper, or an alloy of these metals.
  • the lead wire 11 for the heating electrode connected to the heating electrode 9 is connected to the heating device 13 through the lumen 4.
  • the diameter of the lead wire 11 for the heating electrode is preferably 0.1 mm to 1 mm.
  • the material of the lead wire 11 for the heating electrode examples include copper, silver, gold, platinum or tungsten, or an alloy of these metals. Further, from the viewpoint of preventing a short circuit, it is preferable that the lead wire 11 for the heating electrode is provided with an electrically insulating protective coating such as fluororesin.
  • the heating device 13 is preferably a high frequency generator, and the frequency of the high frequency current supplied to the heating electrode 9 is preferably 100 kHz or more from the viewpoint of preventing electric shock of the patient.
  • the processor 26 in the heating device typically comprises a general purpose computer processor having a suitable front end and interface circuit for receiving signals from the balloon-equipped ablation catheter 1.
  • the processor 26 may be programmed in software to perform the functions described herein.
  • one or more of the constituent parts included in the heating device 13 may be configured as separate hardware, or a part thereof may be shared. At least a part of the heating device 13 may be configured by software. A part of the heating device 13 may be physically separated from each other. Further, the heating device 13 may be able to cooperate with some of the constituent parts by communication with other constituent parts through a network. Further, the heating device 13 may be located on a device in which a part of the components can communicate with other components via an external network, for example, a server or a database on the cloud.
  • the temperature sensor 10 is preferably fixed to the heating electrode 9 or the catheter shaft 2a from the viewpoint of stably measuring the internal temperature of the balloon 3, but from the viewpoint of measuring the surface temperature of the balloon 3, the balloon 3 It may be fixed to the inner surface.
  • Examples of the temperature sensor 10 include a thermocouple or a resistance temperature detector.
  • the temperature sensor lead wire 12 connected to the temperature sensor 10 is connected to the temperature control unit through the lumen 4.
  • the diameter of the temperature sensor lead wire 12 is preferably 0.05 mm to 0.5 mm.
  • the temperature sensor 10 is a resistance temperature detector, for example, copper, silver, gold, platinum or tungsten, or an alloy of these metals can be mentioned. Further, from the viewpoint of preventing a short circuit, it is preferable that the lead wire 12 for the temperature sensor is provided with an electrically insulating protective coating such as fluororesin. If the temperature sensor 10 is a thermocouple, it is preferably made of the same material as the thermocouple. For example, in the case of a T-type thermocouple, copper and constantan, and in the case of a K-type thermocouple, chromel and alumel are mentioned. Be done.
  • the pressure sensor 6 is connected to the pressure measuring unit 18, and the pressure measuring unit 18 is connected to the heating device 13.
  • the pressure sensor lead wire 17 can be made of the same material as the temperature sensor lead wire 12.
  • a contrast medium or a contrast medium diluted with physiological saline as the heating liquid 14.
  • an ionic contrast agent or a contrast agent diluted with physiological saline is preferable.
  • the syringe 19 communicates with the balloon 3 via the extension tube 28 and the lumen 4.
  • any device may be used as the device to be arranged outside the balloon-equipped ablation catheter 1 used for injecting and sucking the liquid into the balloon 3.
  • the vibration applying device 25 applies vibration to the liquid inside the balloon 3 by repeatedly sucking and discharging a minute volume of the heating liquid. By applying vibration to the heating liquid in the balloon, the liquid filled inside the balloon 3 is agitated, and the temperature of the balloon surface can be easily maintained uniformly.
  • Examples of the vibration applying device 25 that applies vibration to the heating liquid in the balloon include a roller pump, a diaphragm pump, a bellows pump, a vane pump, a centrifugal pump, or a device including a pump including a combination of a piston and a cylinder.
  • the estimated cauterization depth is determined from a particular reference table based on heating temperature, cauterization time and balloon volume, as well as a mathematical formula that correlates with the balloon pressure selected from the reference tables.
  • FIG. 8 shows a flowchart of the operator controlling the ablation catheter system with a balloon and the procedure using the system.
  • the surgeon first inserts a catheter into the heart and presses a balloon against the target site.
  • the surgeon sets the heating temperature and cauterization time values in the balloon-equipped ablation catheter system.
  • the processor in the balloon-equipped ablation catheter system calculates the balloon volume from the amount injected into the balloon, and the pressure is measured when the tissue comes into contact with the balloon and the operator fixes the balloon position. Based on these set values and measured values, the estimated cauterization depth by ablation using an ablation catheter with a balloon to be subsequently performed can be calculated by the following method.
  • the estimated cauterization depth (D) correlates with the balloon pressure (P) for each heating temperature, cauterization time, and balloon volume
  • the estimated cauterization depth is calculated from the following equation 1.
  • D k * P 2 + k'* P + t ⁇ ⁇ ⁇ Equation 1
  • D represents the estimated cauterization depth
  • t is the reference table based on heating temperature, cauterizing time and balloon volume. It is a constant selected from, and P represents the value of the balloon pressure.
  • the balloon pressure (P) the estimated cauterization depth (D) can be calculated by using either the balloon internal pressure or the balloon contact pressure.
  • the estimated cauterization depth (D) can be calculated using the reference table corresponding to each of the balloon internal pressure and the balloon contact pressure.
  • a reference table showing the relationship between the heating temperature, the cauterizing time and the balloon volume, and the proportionality constant k and the constant t can be prepared in advance and recorded on a processor or a recording medium.
  • the estimation formula is expressed by the following formula 2.
  • the estimated cauterization depth (D) can be obtained by substituting the measured value of the balloon volume by the measuring device into this estimation formula.
  • This estimated cauterization depth (D) is shown to the operator performing the ablation procedure using a display device such as a display.
  • the surgeon can perform various procedures using the estimated cauterization depth to obtain the desired cauterization depth. For example, the surgeon can obtain the desired cauterization depth by adjusting the heating temperature, cauterization time, balloon volume and balloon pressure.
  • a processor is required to obtain a set estimated cauterization depth for the obtained balloon pressure and balloon volume values in addition to the estimated cauterization depth values.
  • the heating temperature and cauterization time can be output. At this time, if there is only one combination of the required heating temperature and the cauterization time, the processor outputs the combination. When two or more combinations of the required heating temperature and the cauterization time are calculated, the combination with the shortest cauterization time is selected from the combinations and output by the processor.
  • the target estimated cauterization depth is input, and the processor calculates and displays the heating temperature and the cauterization time at which the target estimated cauterization depth is obtained based on the balloon pressure and the balloon volume obtained by the measurement. It may be output to.
  • the term "length” means the length in the longitudinal direction.
  • a polyurethane tube having an outer diameter of 3.6 mm, an inner diameter of 3.0 mm, and a length of 1000 mm was molded to form an outer tube 21. Further, a polyamide tube having an outer diameter of 1.6 mm, an inner diameter of 1.2 mm, and a length of 1100 mm was molded to form an inner tube 20. Handles 27 were connected to their rear ends.
  • a copper wire having a diameter of 0.26 mm and a length of 1700 mm and having an electrically insulating coating made of perfluoroalkoxyalkane was used as a lead wire 11 for a heating electrode, and an electrically insulating coating made of polytetrafluoroethylene was applied.
  • a constantan wire having a diameter of 0.13 mm and a length of 1500 mm was used as a lead wire 12 for a temperature sensor.
  • the electrically insulating coating applied to the lead wire 11 for the heating electrode is peeled off by 200 mm and the electrically insulating coating applied to the lead wire 12 for the temperature sensor is peeled off by 20 mm, starting from a position 25 mm from the tip of the inner tube 20.
  • the heating electrode lead wire 11 was wound around the inner tube 20 in a coil shape while sandwiching the temperature sensor lead wire 12 between the heating electrode lead wire 11 and the inner tube 20. At this time, the coiled portion of the heating electrode lead wire 11 forms the heating electrode 9, and at the starting point of the coiled portion, the heating electrode lead wire 11 and the temperature sensor lead wire 12 are electrically insulated.
  • a thermocouple which is a temperature sensor 10, was formed by contacting the portions where the electrode coating was peeled off.
  • a coil-shaped heating electrode 9 and a temperature sensor 10 having a length of 13 mm were formed on the inner tube 20.
  • the lead wire 11 for the heating electrode and the lead wire 12 for the temperature sensor were welded and fixed to each other.
  • a polyurethane tube was fixed on the inner tube 20 by heat welding at the front and rear ends of the heating electrode 9.
  • the pressure sensor 6 was fixed behind the heating electrode 9 of the inner tube 20 and the temperature sensor 10 with a polyurethane-based adhesive, and the pressure sensor lead wire 17 was connected. The other end of the pressure sensor lead wire 17 was inserted into the lumen 4 and connected to the pressure measuring unit 18 via the handle 27. By fixing the pressure sensor 6 to the inner tube 20 in this way, the balloon internal pressure can be measured.
  • the balloon 3 is inserted from the tip side of the inner tube 20, and the rear end of the balloon 3 is fixed to the tip of the outer tube 21 by heat welding, and the tip of the outer cylinder shaft and the rear end of the balloon are fixed to each other. It was the part that was made.
  • the tip of the balloon 3 was fixed to the inner tube 20 by heat welding.
  • the lead wire 11 for the heating electrode and the lead wire 12 for the temperature sensor 12 were connected to the heating device 13 by inserting the lumen 4 between the outer tube 21 and the inner tube 20 and the inside of the handle 27. ..
  • a three-way stopcock 29 is attached to the branch portion of the handle 27, a balloon volume sensor 16 is attached to one branch portion of the three-way stopcock 29, an extension tube 28 is attached to the other branch portion, and the extension tube 28 is further connected to the vibration applying device 25. bottom.
  • the volume of the balloon can be measured, and the vibration from the vibration applying device 25 is transmitted to the inside of the balloon 3 via the extension tube 28, the handle 11, and the lumen 4 between the outer tube 21 and the inner tube 20.
  • a balloon catheter of Example 1 (hereinafter, “Example 1”) was prepared by forming a path for applying vibration to the liquid. As described above, in the first embodiment, the balloon internal pressure, the balloon volume, and the heating temperature of the balloon 3 can be measured.
  • Example 2 the balloon catheter of Example 2 was prepared. The differences from Example 1 will be described below.
  • a pressure sensor 6 was attached to the surface of the balloon 3 with a polyurethane-based adhesive, and a pressure sensor lead wire 17 was attached to the pressure sensor 6.
  • the pressure sensor lead wire 17 has the same specifications as the temperature sensor lead wire 12 except that the material is copper wire.
  • the pressure sensor lead wire 17 was routed in the same manner as the temperature sensor lead wire 12, and the other end on the hand side was connected to the pressure measurement unit 18.
  • FIG. 10 shows an experimental system for evaluating the relationship between the balloon internal pressure and the cauterization depth using the system of Example 1.
  • a plate-shaped electrode 43 (model number 354; manufactured by ValleyLab), which is a counter electrode plate of the heating electrode 9 attached to the inner wall of the water tank 42, was connected to the heating device 13.
  • the balloon 3 of the ablation catheter 1 with a balloon was immersed in the water tank 42 in a state of being pressed against the myocardium 45 having a shape imitating a pulmonary vein, and the internal pressure of the balloon was measured.
  • the three-way stopcock 29 was switched so that the vibration applying device 25 and the lumen 4 communicated with each other.
  • the heating device 13 and the vibration applying device 25 were operated at the same time, the balloon 3 was heated at a heating temperature of 70 ° C., and ablation was performed for 180 seconds.
  • the ablated myocardium 45 was removed and incised and the ablation depth was measured using a scale or image.
  • FIG. 11 is a graph showing the relationship between the balloon internal pressure and the cauterization depth during ablation for each balloon volume (mL) using one embodiment of the present invention.
  • the horizontal axis represents the balloon internal pressure (mmgHG), and the vertical axis represents the cauterization depth (mm).
  • the cauterization depth and the balloon internal pressure are correlated with each other for each balloon volume.
  • a reference table for the correlation between the cauterization depth and the balloon internal pressure for each balloon volume was created, and it was confirmed that the following formula holds as an estimation formula for the cauterization depth based on the correlation with each other. did it.
  • FIG. 12 shows an enlarged detailed view of the vicinity of the balloon of the experimental system for evaluating the balloon contact pressure and the cauterization depth using the system of Example 2.
  • the overall arrangement is the same as in FIG. 35 L of physiological saline was placed in the water tank 42 and kept at 37 ° C.
  • the plate-shaped electrode 43 (model number 354; manufactured by ValleyLab), which is a counter electrode plate of the heating electrode 9, attached to the inner wall of the water tank 42 was connected to the heating device 13.
  • the balloon 3 of the ablation catheter 1 with a balloon was immersed in the water tank 42 in a state of being pressed against the myocardium 45 having a shape imitating a pulmonary vein, and the balloon contact pressure was measured.
  • the vibration applying device 25 and the lumen 4 were communicated with each other, the heating device 13 and the vibration applying device 25 were operated at the same time, the balloon 3 was heated at a heating temperature of 73 ° C., and ablation was performed for 180 seconds.
  • the ablated myocardium 45 was taken out and incised, and the ablation depth was measured using a scale or an image.
  • FIG. 13 is a graph showing the relationship between the balloon contact pressure during ablation and the cauterization depth according to an embodiment of the present invention.
  • the horizontal axis represents the balloon contact pressure, and the vertical axis represents the cauterization depth.
  • the ablation is started by inputting the relationship between the heating temperature, the cauterization time, the balloon volume, the balloon pressure and the cauterization depth into the processor in advance. Prior to this, the surgeon can know the estimated cauterization depth or can be controlled by the processor to achieve the cauterization depth desired by the surgeon.
  • the present invention can be used as a balloon catheter for treating arrhythmia such as atrial fibrillation, endometriosis, cancer or hypertension.
  • Inner tube 21 ... ⁇ Outer tube, 22 ⁇ ⁇ ⁇ central lumen, 23 ⁇ ⁇ ⁇ guide wire, 25 ⁇ ⁇ ⁇ vibration applying device, 26 ⁇ ⁇ ⁇ processor, 27 ⁇ ⁇ ⁇ handle, 28 ⁇ ⁇ ⁇ extension tube, 29 ⁇ ⁇ ⁇ three sides Live plug, 42 ... water tank, 43 ... counter electrode plate, 44 ... cauterization test device, 45 ... pig myocardium, 46 ... funnel (for meat holding), 47 ... contact pressure sensor

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US17/915,052 US12256973B2 (en) 2020-03-31 2021-03-31 Balloon ablation catheter system and method of controlling same
EP21779546.7A EP4129223A4 (en) 2020-03-31 2021-03-31 BALLOON ABLATION CATHETER SYSTEM AND METHODS OF CONTROLLING THE SAME
JP2021519186A JPWO2021201101A1 (https=) 2020-03-31 2021-03-31
CN202180025227.XA CN115279291A (zh) 2020-03-31 2021-03-31 带球囊的消融导管系统及其控制方法
KR1020227026876A KR20220159353A (ko) 2020-03-31 2021-03-31 벌룬 부착 어블레이션 카테터 시스템 및 그 제어 방법

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CN116158800B (zh) * 2023-02-15 2024-07-12 乐普（北京）医疗器械股份有限公司 一种冠状窦脉冲球囊控制方法及控制装置
CN116687469A (zh) * 2023-05-31 2023-09-05 南京明基医院有限公司 一种心脏稳定装置

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EP4129223A1 (en) 2023-02-08
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US12256973B2 (en) 2025-03-25
CN115279291A (zh) 2022-11-01

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