WO2017056551A1 - Système de cathéter - Google Patents

Système de cathéter Download PDF

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Publication number
WO2017056551A1
WO2017056551A1 PCT/JP2016/065877 JP2016065877W WO2017056551A1 WO 2017056551 A1 WO2017056551 A1 WO 2017056551A1 JP 2016065877 W JP2016065877 W JP 2016065877W WO 2017056551 A1 WO2017056551 A1 WO 2017056551A1
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WO
WIPO (PCT)
Prior art keywords
power
electrode
electrodes
power supply
unit
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PCT/JP2016/065877
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English (en)
Japanese (ja)
Inventor
久生 宮本
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日本ライフライン株式会社
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Filing date
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Publication of WO2017056551A1 publication Critical patent/WO2017056551A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current

Definitions

  • the present invention relates to a catheter system that is used for the treatment of arrhythmia, for example, and includes a mechanism for performing ablation of an affected area.
  • An ablation catheter is inserted into a body (for example, the inside of the heart) through a blood vessel and used for arrhythmia examination or treatment.
  • a body for example, the inside of the heart
  • the shape of the vicinity of the distal end (distal end) inserted into the body is the operation of the operation unit attached to the proximal end (proximal end, rear end, proximal side) disposed outside the body. In response to this, it changes (deflects and curves) in one direction or both directions.
  • the shape near the tip is fixed.
  • ablation catheters with a single electrode were developed. However, when a single electrode is used, it takes time to cauterize, and thereafter, an ablation catheter having a plurality of electrodes was developed.
  • a voltage having the same phase is applied between each electrode and the counter electrode plate (unipolar method).
  • the portion to be cauterized is limited to the vicinity of each electrode in the direction between the electrode and the counter electrode plate, and cauterization is less likely to occur between the electrodes, resulting in unevenness in cauterization. For this reason, in order to cauterize the entire part that requires ablation, it is necessary to shift the position of the ablation catheter and perform the treatment a plurality of times.
  • the power applied between each electrode and the counter electrode plate is increased (for example, 100 W or more) and the energization time is increased, so that a wide range can be obtained at a time. It is possible to cauterize the part, but the temperature rise in the vicinity of the counter electrode plate exceeds the allowable range, causing adverse effects such as low temperature burns and serious complications such as esophageal fistula due to the temperature rise of each electrode. It can also cause. In particular, when cauterizing the left atrium (for example, pulmonary vein isolation), the temperature of the esophagus rises too much and the energization must be stopped.
  • esophageal disorders eg, esophageal fistula
  • the output of the ablation catheter is too high (for example, 100 W or more)
  • the temperature of the counter electrode plate will rise too much.
  • two counter electrode plates may be affixed, but the required size of the counter electrode plate becomes as large as about 10 cm ⁇ 25 cm, and there is a limit to affixing on the back of a person.
  • a bipolar cautery is also known in which a voltage is applied between the electrodes.
  • ablation between electrodes is possible, but it is not effective for cauterization in the depth direction.
  • the present invention has been made in view of such problems, and an object thereof is to provide a technique capable of efficiently performing cauterization using an ablation catheter with low output.
  • An embodiment of the present invention is a catheter system.
  • the catheter system includes a counter electrode plate, a plurality of electrodes on the distal side, an ablation catheter that is placed opposite to the counter electrode plate with a patient sandwiched during surgery, and a plurality of electrodes that are adjacent to each other.
  • a first power supply unit that supplies AC power during ablation to one of the electrodes; and a second power supply unit that supplies AC power during ablation to the other electrode among the adjacent electrodes.
  • a phase difference is generated between the AC power supplied to the other electrode and the AC power supplied to the other electrode.
  • the catheter system of the above aspect includes a control unit that controls the phase difference to a predetermined value.
  • the control unit may control the phase difference for a specific adjacent electrode among the plurality of electrodes.
  • the phase difference may be approximately 180 degrees.
  • cauterization using an ablation catheter can be performed efficiently with low output.
  • FIG. 1 is a block diagram schematically illustrating an example of the overall configuration of a catheter system according to Embodiment 1.
  • FIG. It is the figure which represented typically the schematic structure of the ablation catheter. It is a graph which shows the potential difference (V1-V2) between the voltage V1 and the voltage V2 which are each applied between a counter electrode plate and two adjacent ring electrodes, and two adjacent ring electrodes.
  • 10 is a block diagram schematically illustrating an example of the overall configuration of a catheter system according to Embodiment 2.
  • FIG. 1 is a block diagram schematically illustrating an example of the overall configuration of a catheter system according to Embodiment 1.
  • FIG. 1 is a block diagram schematically illustrating an overall configuration example of a catheter system 400 according to the first embodiment.
  • the catheter system 400 is used for treating arrhythmia or the like in a patient (the patient 20 in this example).
  • the catheter system 400 includes an ablation catheter 1, a counter electrode 30, and a power supply device 300.
  • the ablation catheter 1 is an electrode catheter that is inserted into the body of a patient 20 through a blood vessel and performs treatment such as arrhythmia by ablating the affected area.
  • the ablation catheter 1 may have an irrigation mechanism that causes a predetermined irrigation liquid (for example, physiological saline) to flow out (inject) from the distal end P1 side during ablation.
  • a predetermined irrigation liquid for example, physiological saline
  • FIG. 2 is a diagram schematically showing a schematic configuration of the ablation catheter 1.
  • the ablation catheter 1 has a shaft 11 (catheter shaft) as a catheter body and an operation unit 12 attached to the proximal end of the shaft 11.
  • the shaft 11 is composed of a flexible tubular structure (tubular member) and has a shape extending along its own axial direction (Z-axis direction). Further, the shaft 11 has a so-called single lumen structure in which one lumen (pore or through hole) is formed so as to extend along the axial direction of the shaft 11, or a plurality of (for example, four) lumens are formed. So-called multi-lumen structure. In the shaft 11, both a region having a single lumen structure and a region having a multi-lumen structure may be provided. Various kinds of thin wires (not shown) (conductive wires, operation wires, etc.) are inserted through such lumens while being electrically insulated from each other.
  • a mechanism for measuring the temperature in the vicinity of the front end P1 (around the affected area) is provided.
  • a thermocouple or the like as a temperature sensor for measuring such temperature is inserted through the lumen inside the shaft 11. The temperature in the vicinity of the tip P1 measured in this way is supplied from the ablation catheter 1 to the power supply device 300 as measured temperature information Tm.
  • Such a shaft 11 is made of, for example, a synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane.
  • the axial length of the shaft 11 is about 500 to 1200 mm (for example, 1170 mm), and the outer diameter of the shaft 11 (the outer diameter of the XY cross section) is about 0.6 to 3 mm (for example, 2). 0.0 mm).
  • a plurality of electrodes are provided. Is provided. Specifically, the ring-shaped electrodes 111 a, 111 b, 111 c and the tip electrode 112 are arranged at a predetermined interval in this order toward the most distal side of the shaft 11 in the vicinity of the tip P 1.
  • the ring-shaped electrodes 111 a, 111 b, and 111 c are each fixedly disposed on the outer peripheral surface of the shaft 11, while the tip electrode 112 is fixedly disposed at the forefront of the shaft 11.
  • These electrodes are electrically connected to the operation unit 12 through a plurality of conductive wires (not shown) inserted into the lumen of the shaft 11 described above.
  • Each of the ring-shaped electrodes 111a, 111b, 111c and the tip electrode 112 has good electrical conductivity, such as aluminum (Al), copper (Cu), stainless steel (SUS), gold (Au), platinum (Pt), etc. It is made of a simple metal material. In addition, in order to make the contrast property with respect to X-rays favorable at the time of use of the ablation catheter 1, it is preferable to be comprised with platinum or its alloy. Further, the outer diameters of the ring-shaped electrodes 111a, 111b, 111c and the tip electrode 112 are not particularly limited, but are desirably approximately the same as the outer diameter of the shaft 11 described above.
  • the operation unit 12 is attached to the proximal end of the shaft 11 and includes a handle 121 (gripping unit) and a rotating plate 122.
  • the handle 121 is a portion that is gripped (gripped) by an operator (doctor) when the ablation catheter 1 is used. Inside the handle 121, the various thin wires described above extend from the inside of the shaft 11.
  • the rotating plate 122 is a member for performing a deflection movement operation (swing operation), which is an operation for deflecting the vicinity of the tip of the shaft 11. Specifically, here, as shown by the arrow in FIG. 2, an operation of rotating the rotating plate 122 along the rotation direction d1 is possible.
  • a deflection movement operation tilt operation
  • the shaft 11 of the ablation catheter 1 is inserted into the body of the patient 20 through the blood vessel when treating arrhythmia or the like.
  • the shape of the vicinity of the tip P1 of the shaft 11 inserted into the body changes, for example, in one direction or both directions.
  • an operation wire (not shown) in the shaft 11 moves to the proximal end side. Be pulled.
  • the vicinity of the tip of the shaft 11 is curved along the direction d2 indicated by the arrow in FIG.
  • the counter electrode plate 30 As shown in FIG. 1, the counter electrode plate 30 is used in a state of being mounted on the body surface of the patient 20 during ablation. As will be described later, high-frequency energization is performed between the counter electrode plate 30 and the electrode of the ablation catheter 1 inserted into the body of the patient 20 during ablation.
  • the power supply device 300 is a device that supplies AC power (for example, output power Pout composed of radio frequency (RF)) at the time of ablation to the ablation catheter 1 and the counter electrode plate 30.
  • AC power for example, output power Pout composed of radio frequency (RF)
  • RF radio frequency
  • the power supply device 300 includes an input unit 310, a first power supply unit 320, a first voltage measurement unit 322, a first current measurement unit 324, a second power supply unit 330, and a second voltage measurement unit 332.
  • a second current measuring unit 324, a control unit 350, and a display unit 370 In the example shown in FIG. 1, the power supply to the adjacent ring electrodes 111a and 111b among the electrodes provided in the ablation catheter 1 is illustrated, but the power supply to the other adjacent ring electrodes 111b and 111c, etc. Is omitted.
  • the input unit 310 is a part for inputting various setting values and an instruction signal for instructing a predetermined operation to be described later.
  • These set values are input by an operator (for example, an engineer) of the power supply apparatus 300.
  • the phase difference ⁇ may not be input by the operator but may be set in the power supply apparatus 300 in advance at the time of shipping the product.
  • the set value input by the input unit 310 is supplied to the control unit 350.
  • the input unit 310 is configured using, for example, a predetermined dial, button, touch panel, or the like.
  • the first power supply unit 320 is a part that supplies the output power Pout1 described above to the ring electrode 111a and the counter electrode plate 30 of the ablation catheter 1 in accordance with a control signal CTL1 described later.
  • the first power supply unit 320 is configured using a predetermined power supply circuit (for example, a switching regulator).
  • a predetermined power supply circuit for example, a switching regulator.
  • the frequency is, for example, about 450 kHz to 550 kHz (for example, 500 kHz).
  • the first voltage measurement unit 322 is a part that measures (detects) the voltage in the output power Pout1 output from the first power supply unit 320 as needed, and is configured using a predetermined voltage detection circuit.
  • the voltage (measured voltage Vm1) measured by the first voltage measuring unit 322 in this way is output to the control unit 350.
  • the first current measurement unit 324 is a part that measures the current in the output power Pout1 output from the first power supply unit 320 as needed, and is configured using a predetermined current detection circuit.
  • the current (measured current Im1) measured by the first current measurement unit 324 is output to the control unit 350.
  • the second power supply unit 330 is a part that supplies the output power Pout2 described above to the ring electrode 111b and the counter electrode plate 30 of the ablation catheter 1 in accordance with a control signal CTL2 described later.
  • the second power supply unit 330 is configured using a predetermined power supply circuit (for example, a switching regulator).
  • a predetermined power supply circuit for example, a switching regulator.
  • the frequency of the output power Pout1 is preferably equal to the frequency of the output power Pout2.
  • the second voltage measurement unit 332 is a part that measures (detects) the voltage in the output power Pout2 output from the second power supply unit 330 as needed, and is configured using a predetermined voltage detection circuit.
  • the voltage (measured voltage Vm2) measured by the second voltage measuring unit 332 is output to the control unit 350.
  • the second current measurement unit 334 is a part that measures the current in the output power Pout2 output from the second power supply unit 330 as needed, and is configured using a predetermined current detection circuit.
  • the current (measured current Im2) measured by the second current measurement unit 334 is output to the control unit 350.
  • the control unit 350 is a part that controls the entire power supply apparatus 300 and performs predetermined arithmetic processing, and is configured using, for example, a microcomputer. Specifically, first, control unit 350 has a function of calculating measured power Pm1 (corresponding to the power value of output power Pout1) and measured power Pm2 (corresponding to the power value of output power Pout2) described below. . In addition, the control unit 350 uses the control signals CTL1 and CTL2 to control the supply operation of the output power Pout1 in the first power supply unit 320 and the output power Pout2 in the second power supply unit 330 (power supply control function and Phase difference control function).
  • the control unit 350 generates the control signal CTL1 based on the above-described measured temperature information Tm, and outputs the control signal CTL1 to the first power supply unit 320, thereby adjusting (finely adjusting the magnitude and phase of the output power Pout1. adjust. Specifically, in order to keep the temperature near the tip P1 of the shaft 11 indicated by the actually measured temperature information Tm substantially constant (preferably constant), in other words, this temperature is substantially equal to the preset target temperature Tt. The output power Pout1 is adjusted so as to become (preferably equal).
  • control unit 350 performs control so that the value of the output power Pout1 increases when the temperature near the tip P1 is equal to or lower than the target temperature Tt.
  • control is performed so that the value of the output power Pout decreases.
  • the actual output power Pout1 is supplied after appropriate power adjustment is made based on the input set power Ps. In other words, it can be said that the value of the set power Ps and the value of the actual output power Pout1 (actually measured power Pm1) do not necessarily match.
  • control unit 350 adjusts (finely adjusts) the magnitude and phase of the output power Pout2 by outputting the control signal CTL2 to the second power supply unit 330.
  • the control unit 350 performs control so that a predetermined phase difference ⁇ is generated between the phase of the output power Pout1 and the phase of the output power Pout2.
  • the phase difference ⁇ may be input by the input unit 310 or may be set in advance at the time of shipment.
  • the phase difference ⁇ is set in the range of 0 ° ⁇ ⁇ 360 °, but when the phase difference ⁇ is approximately 180 ° (specifically, 160 ° to 200 °), preferably 180 °, Can be maximized.
  • FIG. 3 shows a voltage V1 applied between the counter electrode plate 30 and the ring electrode 111a, a voltage V2 applied between the counter electrode plate 30 and the ring electrode 111b, and the ring electrode 111a and the ring electrode 111b.
  • the control unit 350 may perform phase control so that a phase difference ⁇ is generated for all adjacent electrodes provided in the ablation catheter 1, but among the plurality of electrodes provided in the ablation catheter 1, You may perform the phase control mentioned above with respect to the specific adjacent electrode.
  • the electrode for phase control may be input by the input unit 310. According to this, a site requiring treatment can be cauterized accurately.
  • the display unit 370 is a part (monitor) that displays various information and outputs the information to the outside.
  • Examples of display target information include the above-described various set values (set power Ps and the like) input from the input unit 310, actual power Pm1, actual power Pm2, and ablation catheter 1 supplied from the control unit 350. Measured temperature information Tm and the like.
  • the information to be displayed is not limited to these information, and other information may be displayed instead of or in addition to other information.
  • Such a display unit 370 is configured using a display by various methods (for example, a liquid crystal display, a CRT (Cathode Ray Tube) display, an organic EL (Electro Luminescence) display, or the like).
  • phase control can be performed on specific adjacent electrodes, so that a site requiring treatment can be cauterized accurately.
  • FIG. 4 is a block diagram schematically illustrating an example of the overall configuration of the catheter system 400 according to the second embodiment.
  • the same phase power is supplied from the first power supply unit 320 and the second power supply unit 330, and the control unit 350 does not substantially perform phase control.
  • the output terminal A2 of the second power supply unit 330 having the same polarity as the output terminal A1 of the first power supply unit 320 connected to the ring electrode 111a is connected to the counter electrode plate 30.
  • the output terminal B2 of the second power supply unit 330 having the same polarity as the output terminal B1 of the first power supply unit 320 connected to the counter electrode plate 30 is connected to the ring electrode 111b.
  • the first power supply unit 320 and the second power supply unit 330 are insulated from each other.
  • the present invention can be applied to a catheter system having a mechanism for cauterizing an affected area.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

L'invention concerne un système de cathéter (400) qui comprend une électrode de retour (30), un cathéter d'ablation (1) et un dispositif de source d'alimentation (300). Le dispositif de source d'alimentation (300) comprend une première unité de source d'alimentation (320), une seconde unité de source d'alimentation (330) et une unité de commande (350). La première unité d'alimentation (320) fournit un courant alternatif à une électrode parmi une pluralité d'électrodes disposées au niveau d'une partie distale du cathéter d'ablation (1). La seconde unité de source d'alimentation (330) fournit un courant alternatif à une autre électrode parmi la pluralité d'électrodes disposées au niveau d'une partie distale du cathéter d'ablation (1). L'unité de commande (350) commande la phase de courant alternatif de façon à générer une différence entre la phase du courant alternatif fourni à la première électrode et la phase du courant alternatif fourni à l'autre électrode.
PCT/JP2016/065877 2015-09-30 2016-05-30 Système de cathéter WO2017056551A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2015-192818 2015-09-30
JP2015192818A JP2017064020A (ja) 2015-09-30 2015-09-30 カテーテルシステム

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WO2017056551A1 true WO2017056551A1 (fr) 2017-04-06

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002513617A (ja) * 1998-05-05 2002-05-14 カーディアック ペースメーカーズ，インコーポレイテッド 単極及び二極技術を使用するｒｆ除去装置及び方法
US20140066913A1 (en) * 2012-09-06 2014-03-06 Medtronic Ablation Frontiers Llc Ablation device and method for electroporating tissue cells

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002513617A (ja) * 1998-05-05 2002-05-14 カーディアック ペースメーカーズ，インコーポレイテッド 単極及び二極技術を使用するｒｆ除去装置及び方法
US20140066913A1 (en) * 2012-09-06 2014-03-06 Medtronic Ablation Frontiers Llc Ablation device and method for electroporating tissue cells

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