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WO1996010950A1 - Ablation au catheter par radiofrequence et impulsions haute tension combinees - Google Patents

Ablation au catheter par radiofrequence et impulsions haute tension combinees Download PDF

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Publication number
WO1996010950A1
WO1996010950A1 PCT/US1995/013129 US9513129W WO9610950A1 WO 1996010950 A1 WO1996010950 A1 WO 1996010950A1 US 9513129 W US9513129 W US 9513129W WO 9610950 A1 WO9610950 A1 WO 9610950A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrode
high voltage
ablation
tissue
pulses
Prior art date
Application number
PCT/US1995/013129
Other languages
English (en)
Inventor
Wilton W. Webster, Jr.
Original Assignee
Cordis Webster, Inc.
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
Application filed by Cordis Webster, Inc. filed Critical Cordis Webster, Inc.
Priority to AU39551/95A priority Critical patent/AU3955195A/en
Publication of WO1996010950A1 publication Critical patent/WO1996010950A1/fr

Links

Classifications

    • 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
    • A61B5/6855—Catheters with a distal curved tip
    • 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
    • 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
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • 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
    • A61B18/1402—Probes for open surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/043—Arrangements of multiple sensors of the same type in a linear array

Definitions

  • the present invention relates to catheter ablation of cardiac tissue and, in particular, to such treatments where radiofrequency is combined with short high voltage, low energy electrical pulses for the treatment of ventricular tachycardia.
  • tachyrhythmia ventricular tachycardia
  • VT ventricular tachycardia
  • the present invention is a means for treating this form of VT by a new form of electrical ablation.
  • Catheter ablation (destruction of tissue in the heart by means of an electrode catheter) has been found to be an efficacious means of interrupting accessory electrical pathways between the atria and ventricles. These accessory pathways can cause tachycardia, which is referred to as supraventricular tachycardia (SVT).
  • SVT supraventricular tachycardia
  • a special electrophysiological catheter is guided through an artery or vein into the patient's heart to the site of the accessory pathway.
  • the catheter is designed to transmit energy from an external source into the site of the accessory pathway in an amount sufficient to ablate the tissue.
  • the ablated tissue is replaced with scar tissue which interrupts the accessory pathway.
  • the normal activity of the heart is thereby restored.
  • a common form of VT is caused by coronary artery disease after it has caused scarring of the ventricle.
  • coronary artery disease causes blockage of blood to heart muscle, tissue may die and the result is that this dead tissue becomes scar tissue.
  • these scars contain strands of living tissue which continue to conduct and thereby become abhorrent pathways through the scar. Under certain conditions, these pathways may again trigger the surrounding muscle into a new wave of excitation much sooner than the heart is scheduled to beat again.
  • One type of energy used to ablate cardiac tissues is high-voltage, high energy direct current delivered in one or more pulses. Such high energy electrical shocks are very effective in creating lesions of adequate size.
  • severe complications including hemodynamic deterioration, induction of ventricular fibrillation, conductive disturbances, internal embolism and perforation of the ventricular wall, have been reported with this procedure.
  • RF ablation An alternative to direct current, high energy ablation is radiofrequency (RF) ablation.
  • RF current is delivered to the ablation site and heats the cardiac tissue sufficiently to form a lesion.
  • RF ablation has been shown to be safe and efficacious in treating SVT caused by accessory electrical pathways between either atrium and ventricles or AV nodal reentry circuits.
  • the sites of the accessory electrical pathways tend to be relatively small and not too deep.
  • a typical area of ablation has an area of about 5-6 mm diameter and a depth of 3-5 mm. Lesions of this size can usually be formed by RF ablation without the ablation electrode overheating.
  • RF ablation has been found to be less effective in treating VT.
  • affected sites tend to be more diffuse and encompass a greater depth, e.g., 1 .5 cm, than the sites involved in SVT. Therefore, treatment of VT by RF ablation of the tissue requires destruction of a larger volume of tissue.
  • the RF ablation current may have to penetrate a scarred area which is difficult because of the lack of conduction in the scar tissue.
  • the need to destroy a larger volume of tissue and penetrate the scar to treat VT introduces a number of problems for RF catheter ablation.
  • One problem is the inability to keep the electrode cool while causing sufficient heating to ablate the required volume of tissue. If the ablation electrode gets too hot, coagulation will occur at the tip, reducing conductivity.
  • the catheter must be removed, cleaned and reinserted.
  • the electrode must have sufficient size to deliver the required amount of RF current. This means that larger than desired ablation electrodes must be used. Further, it is always difficult to maintain sufficient contact pressure between the electrode and endocardium and to keep the electrode in a stabile position throughout the RF current delivery, particularly since the heart continues to beat during the procedure.
  • a method of treating ventricular tachycardia by a catheter from within the ventricle comprises contacting tissue of the heart with an ablation electrode at a site of an accessory electrical pathway. Radiofrequency energy is delivered to the tissues throug the electrode for a time sufficient to confirm the site of the accessory electrical pathway and to preheat the cardiac tissue at that site. After the delivery of the radiofrequency energy, short high voltage, low energy electrical pulses are delivered to the tissue through the same electrode to thereby form a lesion and block the accessory electrical pathway.
  • FIG. 1 is an ablation catheter in accordance with a preferred embodiment of the present invention
  • FIG. 2 is a mapping/ablation catheter in accordance with another preferred embodiment of the present invention
  • FIG. 3 is a block diagram of a preferred high voltage dc pulse generator
  • FIG. 4 is a layout of the front panel of the dc pulse generator of FIG. 3.
  • the present invention overcomes the problems presented with conventional RF ablation techniques by combining RF treatment with short duration high voltage, low energy electrical pulses.
  • the catheter comprises an elongated tubular catheter body 12, a deflectable tip portion 1 at the distal end of the catheter body and a control handle 16 at the proximal end of the catheter body 12.
  • a presently preferred control handle 16 and steering mechanism is disclosed in U.S. Patent No. 4,906,134 to Webster, which is incorporated herein by reference.
  • An ablation electrode 20 is mounted at the distal end of the tip portion 14. This could also be a ring electrode proximal to the tip electrode.
  • An electrode lead wire (not shown) extends from the ablation electrode through the catheter body and control handle to a switch 24.
  • Switch 24 is, in turn, connected to a source 26 of RF energy and a source 28 of short duration high voltage energy pulses.
  • a suitable generator of RF energy is, for example, manufactured by American Cardiac Ablation and sold under the trade designation Liz 88 RF generator.
  • the high voltage DC pulse generator 28 shown as a block diagram in FIG. 3 consists of front panel controls and displays 30, a control board 32, an over current limit board 34 and eight power boards 36.
  • Front panel 30 consists of switches 54 through 62 and light emitting diode (LED) indicators 64 through 70 as illustrated in FIG. 4.
  • Channels switch 62 allows the operator to select the number of channels to fire. This indicates to the control board 32 via line 80 the number of power boards or channels to enable to output the desired voltage level.
  • An indication of power-on is sent to the control board 32 via line 72 upon switching the power switch 54 to the ON position.
  • the channel status LEDs 64 on the front panel flash to indicate the channels enabled in response to pulses via lines 82 from the control board 32.
  • the ready LED 66 lights in response to a signal from the control board 32 over line 84 once the enabled channels are fully charged.
  • the time delay between pulses is selectable from 30 microseconds to 990 microseconds.
  • a pair of delay switches 60 are used to select the delay in units of 10 microseconds in the range of 3 to 99 units.
  • the delay between pulses is indicated to the control board 32 over line 78.
  • the number of 10 microsecond pulses to fire is selected with a pair of pulse switches 58 from 1 pulse to 99 pulses in a pulse train and indicated to the control board 32 over line 76.
  • the fire switch 56 is depressed to initiate the ablation process.
  • the signal to fire is sent to the control board 32 via line 74.
  • the done LED 68 pulses on upon indication from the control board 32 via line 86 that the procedure has successfully completed within the chosen parameters.
  • the fault LED 70 flashes to indicate that the control board 32 batteries are low upon receipt of a pulse over line 88.
  • the fault LED 70 will continuously light to indicate that the current limit of 50 Amperes was exceeded during the ablation process as indicated by the control board 32 via line 88.
  • Two 9 volt batteries are mounted on the rear of the front panel (not shown) to supply + 1 8 Volts and + 9 Volts to the control board 32.
  • FIG. 4 displays a representative embodiment of a front panel layout. Other configurations may be utilized for optimal ease of operator use.
  • the control board 32 includes a microprocessor controller and peripheral
  • CMOS logic It receives operator selections and reports operational and fault status via the front panel 30 switches 54 through 62 and LED indicators 64 through 70.
  • the control board 32 latches the number of channels to fire selected via channels switch 62 upon receipt of the power-on indication from power switch 54.
  • the control board 32 enables the number of power boards 36, via fiber optic interface 94, corresponding to the number of channels to fire selected by the operator. It sends a pulse to channel status LEDs 64 to flash the LEDs corresponding to the channels enabled via line 82.
  • the ready LED 66 is lighted via line 84 once the enabled power boards 36 report a fully charged status to the control board 32 via fiber optic interface 98.
  • the control board 32 commands the firing sequence by sending the selected pulse train to the enabled power boards 36 via high speed fiber optic interface 96 upon indication via line 74 that the operator has depressed fire switch 56. If the preset current limit of 50 amperes is not exceeded during the firing sequence, the control board 32 sends a pulse to done LED 68 via line 86 indicating a successful firing sequence.
  • the control board 32 processes faults and performs diagnostic functions in addition to controlling the ablation procedure.
  • the control board 32 lights fault
  • the over current limit can be caused by a short in the wiring that delivers power or by the selection of too many channels to fire on channel switch 62.
  • the fault LED 70 is pulsed to flash via line 88 when low batteries are detected on the control board 32. If the ready LED 66 is not lighted by the control board 32 via line 84 once the selected number of channels have been enabled, this indicates the batteries on the power boards are too low to fully charge the power stages required.
  • the control board 32 performs built in diagnostic tests to determine the integrity of the input/output circuitry during factory service testing when the channels switch 62 is set to 0 and the power switch 54 is switched to ON.
  • the eight power boards 36 are enabled by the control board 32 over a fiber optic interface 94.
  • the number of channels selected by the operator on channels switch 62 determines the number of power boards 36 that are enabled by the control board 32.
  • Each power board 36 is comprised of two nine volt batteries, two energy storage capacitors, an inverter, a MOSFET power transistor, fiber optic detectors, a high speed power diode, amplifiers, and power sense circuitry. Input power is provided by the'two 9 volt batteries.
  • the energy storage capacitors are charged by the inverter to -425 Volts or 27 joules.
  • a power board 36 requires 30 to 60 seconds to charge to full power after being enabled by the control board 32.
  • a charge status is sent to control board 32 via a fiber optic interface 98 once the energy storage capacitors are fully charged.
  • High speed fiber optic detectors sense the firing pulse from control board 32 emitted over a high speed fiber optic interface 96.
  • the firing pulse is amplified and used to drive the gate or input of the MOSFET power transistor that switches the 400 Volt output of each power board 36 enabled.
  • the power boards 36 are serially connected through the high speed power diode across the output of each board to provide the high voltage output desired.
  • the nominal voltage output is 400 Volts per power board 36.
  • the maximum output voltage is 3200 Volts with all eight power boards 36 enabled at a maximum current of 40 Amperes.
  • the power is output from a rear panel power output 40.
  • the energy stored in the energy storage capacitors may be depleted if a large number of pulses are fired in one ablation. A short delay may occur during charging of the energy storage capacitors.
  • a charge status is then sent to the control board 32 and the ready LED 66 is lighted, indicating the high voltage DC pulse generator 28 is ready to fire.
  • the over current limit detection board 34 senses the current output of the power boards 36 over line 92 using a very low equivalent resistance. The over current circuitry trips once the current reaches approximately 50 Amperes. The over current limit status is sent to control board 32 via a high speed fiber optic interface 90 where it is processed and the fault displayed on front panel 30 fault LED 70.
  • Switch 24 enables the physician to switch from RF energy to high voltage electrical pulses as desired.
  • the ablation procedure of the present invention preferably follows a conventional mapping procedure of the ventricle.
  • an electrode catheter preferably combining a multi-electrode mapping catheter is advanced into the femoral artery to the aorta, across the aortic valve and into the left ventricle.
  • the mapping catheter could also be advanced to the right ventricle.
  • the catheter has been inserted into a vein (usually a femoral, subclavian, or internal jugular vein), then advanced through the inferior vena cava or superior vena cava into the right atrial cavity and then through the tricuspid valve into the right ventricle.
  • a vein usually a femoral, subclavian, or internal jugular vein
  • one or more electrodes are positioned against the endocardium and measurements of the electrical activity are recorded and analyzed. This is done to determine the site of the aberrant electrical pathway or pathways.
  • the ablation catheter of the present invention is inserted into the ventricle along the same route as the mapping catheter. Insertion of the ablation catheter may be done simultaneously with or subsequent to the insertion of the mapping catheter. (It should be noted that quite often the mapping catheter and electrode catheter are combined.)
  • an ablation electrode is positioned under fluoroscopy against the ventricle wall at the site of the aberrant electrical pathway.
  • RF current is then applied to the site.
  • the RF current delivered to the site is preferably in the frequency range of from about 300 to about 600 KHz. Delivery time is typically 10 to 30 seconds while keeping the electrode in a stabile position.
  • the application of RF energy confirms the diagnostic mapping of the site by temporarily interrupting or modifying the aberrant VT circuit.
  • the RF energy also preheats the tissue resulting in lower electrical resistance. In a subsequent ablation by means of short high voltage electrical pulses, the heated tissue is thus more susceptible to destruction for a given pulse voltage. This allows the physician to minimize the voltage required to achieve a desired lesion size.
  • the energy source is then switched, via switch 24, and short high voltage, low energy electrical pulses are delivered to the site to which the RF energy was delivered.
  • the voltage used is up to about 3,000 V to about 3500 V which results in a current of about 30-50 amps or more. If voltages lower than 400 V are used, the treatment tends to be insufficient to form a lesion necessary to result in effective ablation.
  • High voltage, low energy electrical pulses of about 5 to 20 and preferably
  • the number of pulses typically used is about 1 5 to 20 for effective ablation of the tissue required. Such treatments are sufficient to destroy the cell membrane and thereby kill the cells in contact with or in the near vicinity of the electrode. Cells can typically be destroyed to a depth of about 1 .5 cm. The killed cells are replaced with scar tissue thus preserving the integrity of the ventricle wall.
  • the combination of the RF and short high voltage pulses retains much of the safety advantages inherent to RF while effectively providing the larger lesion necessary to treat VT.
  • the electrode does not become excessively hot during use or have to be overly large. This allows the use of a small electrode, keeping within the physical constraints of the catheter size. For effective treatment, only normal contact pressure by the electrode is required.
  • the tip portion 14 carries a plurality of electrodes 32. All electrodes are connected by electrode leads (not shown) to switch 24 via, for example, a rotary plug connector at the proximal end of the control handle 16 as shown in
  • Switch 24 in turn, is connected to a conventional stimulator recorder 30.
  • the tip or ablation electrode 20 is connected through switch 24 to an RF energy source 26 and a high voltage pulse generator 28. Mapping of the ventricle occurs first. Once the aberrant site is located, the switch is turned to supply RF current to the ablation electrode as described above. Once the site is confirmed and preheated, the switch is turned to supply high voltage electrical pulses to the site to thereby ablate the tissue.

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Abstract

Une méthode de traitement de la tachycardie ventriculaire consiste à insérer un cathéter à électrode dans le ventricule. La paroi ventriculaire du c÷ur est mise en contact avec une électrode d'ablation (20) à l'endroit où se situe le chemin électrique aberrant. L'électrode d'ablation (20) envoie une radiofréquence dans le tissu pendant une durée suffisante pour permettre la confirmation de l'emplacement de la voie électrique aberrante ainsi que la préchauffe du tissu. Cette même électrode (20) envoie ensuite des courtes impulsions électriques haute tension dans le tissu de sorte qu'une lésion non conductrice soit formée.
PCT/US1995/013129 1994-10-07 1995-10-06 Ablation au catheter par radiofrequence et impulsions haute tension combinees WO1996010950A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU39551/95A AU3955195A (en) 1994-10-07 1995-10-06 Combined radiofrequency and high voltage pulse catheter ablation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US32018294A 1994-10-07 1994-10-07
US08/320,182 1994-10-07

Publications (1)

Publication Number Publication Date
WO1996010950A1 true WO1996010950A1 (fr) 1996-04-18

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PCT/US1995/013129 WO1996010950A1 (fr) 1994-10-07 1995-10-06 Ablation au catheter par radiofrequence et impulsions haute tension combinees

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WO (1) WO1996010950A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997006727A1 (fr) * 1995-08-18 1997-02-27 Cardiac Crc Nominees Pty. Ltd. Sonde transmurale multipolaire
AU701125B2 (en) * 1995-08-18 1999-01-21 Cathrx Ltd A multipolar transmural probe
EP1782741A2 (fr) 2003-01-09 2007-05-09 Gyrus Medical Limited Génerateur électrochirurgical
WO2010091701A1 (fr) 2009-02-12 2010-08-19 Umc Utrecht Holding B.V. Catheter d'ablation et methode d'isolation electrique de tissu cardiaque
EP3597131A1 (fr) 2018-07-17 2020-01-22 Biosense Webster (Israel) Ltd. Ablation rf pulsée à température régulée
CN114010309A (zh) * 2021-11-03 2022-02-08 成都科莱弗生命科技有限公司 消融系统

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4896671A (en) * 1988-08-01 1990-01-30 C. R. Bard, Inc. Catheter with contoured ablation electrode
US5156151A (en) * 1991-02-15 1992-10-20 Cardiac Pathways Corporation Endocardial mapping and ablation system and catheter probe

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4896671A (en) * 1988-08-01 1990-01-30 C. R. Bard, Inc. Catheter with contoured ablation electrode
US5156151A (en) * 1991-02-15 1992-10-20 Cardiac Pathways Corporation Endocardial mapping and ablation system and catheter probe

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997006727A1 (fr) * 1995-08-18 1997-02-27 Cardiac Crc Nominees Pty. Ltd. Sonde transmurale multipolaire
AU701125B2 (en) * 1995-08-18 1999-01-21 Cathrx Ltd A multipolar transmural probe
EP1782741A2 (fr) 2003-01-09 2007-05-09 Gyrus Medical Limited Génerateur électrochirurgical
EP1782741A3 (fr) * 2003-01-09 2008-11-05 Gyrus Medical Limited Génerateur électrochirurgical
US7717910B2 (en) 2003-01-09 2010-05-18 Gyrus Medical Limited Electrosurgical generator
US20190216538A1 (en) * 2009-02-12 2019-07-18 St Jude Medical, Atrial Fibrillation Division, Inc Ablation catheter and method for electrically isolating cardiac tissue
US20120053581A1 (en) * 2009-02-12 2012-03-01 Frederik Henricus Mattheus Wittkampf Ablation Catheter and Method for Electrically Isolating Cardiac Tissue
US10166067B2 (en) 2009-02-12 2019-01-01 St. Jude Medical, Atrial Fibrillation Division, Inc. Ablation catheter and method for electically isolating cardiac tissue
WO2010091701A1 (fr) 2009-02-12 2010-08-19 Umc Utrecht Holding B.V. Catheter d'ablation et methode d'isolation electrique de tissu cardiaque
EP3597131A1 (fr) 2018-07-17 2020-01-22 Biosense Webster (Israel) Ltd. Ablation rf pulsée à température régulée
JP2020011065A (ja) * 2018-07-17 2020-01-23 バイオセンス・ウエブスター・（イスラエル）・リミテッドＢｉｏｓｅｎｓｅ Ｗｅｂｓｔｅｒ （Ｉｓｒａｅｌ）， Ｌｔｄ． 温度制御されたパルスｒｆアブレーション
EP4338696A2 (fr) 2018-07-17 2024-03-20 Biosense Webster (Israel) Ltd. Ablation par rf pulsé à température régulée
US11974798B2 (en) 2018-07-17 2024-05-07 Biosense Webster (Israel) Ltd. Temperature-controlled pulsed RF ablation
CN114010309A (zh) * 2021-11-03 2022-02-08 成都科莱弗生命科技有限公司 消融系统
WO2023078338A1 (fr) * 2021-11-03 2023-05-11 成都科莱弗生命科技有限公司 Système d'ablation
CN114010309B (zh) * 2021-11-03 2023-10-20 融和医疗科技(浙江)有限公司 消融系统

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Publication number Publication date
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