WO2014132476A1 - Système de cathéter - Google Patents

Système de cathéter Download PDF

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Publication number
WO2014132476A1
WO2014132476A1 PCT/JP2013/075888 JP2013075888W WO2014132476A1 WO 2014132476 A1 WO2014132476 A1 WO 2014132476A1 JP 2013075888 W JP2013075888 W JP 2013075888W WO 2014132476 A1 WO2014132476 A1 WO 2014132476A1
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WIPO (PCT)
Prior art keywords
power
flow rate
liquid
control unit
ablation
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PCT/JP2013/075888
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English (en)
Japanese (ja)
Inventor
小島　康弘
修一 堀内
Original Assignee
日本ライフライン株式会社
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Application filed by 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Priority to CN201380062501.6A priority Critical patent/CN104822335B/zh
Priority to KR1020157023084A priority patent/KR101737253B1/ko
Publication of WO2014132476A1 publication Critical patent/WO2014132476A1/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
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • A61B2018/00029—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids open
    • 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
    • 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
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00744—Fluid flow
    • 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
    • A61B2018/00779—Power or energy
    • 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
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe

Definitions

  • the present invention relates to a catheter system including an irrigation mechanism that is used for treatment of, for example, arrhythmia and that causes a liquid such as physiological saline to flow during ablation of an affected part in the treatment.
  • the electrode catheter is inserted into the body (for example, the inside of the heart) through a blood vessel, and is used for arrhythmia examination and treatment.
  • 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, hand side) disposed outside the body. In response to this, it changes (deflects, curves) in one direction or both directions.
  • the shape near the tip is fixed.
  • ablation catheter in the case of such an electrode catheter for treatment (so-called ablation catheter), the following problems may occur during ablation of the affected area. That is, during ablation surgery for the heart or the like, problems may arise such that the temperature of the treatment portion increases too much and damage occurs, or a blood clot sticks to the treatment portion.
  • the present invention has been made in view of such problems, and an object thereof is to provide a catheter system capable of performing an appropriate irrigation operation.
  • the catheter system of the present invention includes an ablation catheter having an irrigation mechanism, a power supply unit that supplies electric power during ablation to the ablation catheter, a liquid supply unit that supplies irrigation liquid to the ablation catheter, And a control unit for controlling the power supply operation in the power supply unit and the liquid supply operation in the liquid supply unit.
  • the control unit performs control so that a large flow rate operation with a relatively high liquid flow rate is performed in a high power state where the measured power at the time of ablation is equal to or higher than the threshold power, while the measured power is less than the threshold power. In the low power state, control is performed such that the liquid flow rate is a small flow rate operation.
  • the control unit when the control unit shifts from the low power state to the high power state, the control unit quickly switches from the small flow rate operation to the high flow rate operation.
  • the control unit when transitioning from the high power state to the low power state, if the low power state continues for the first standby time during the transition, the large flow rate operation is maintained after the first standby time is maintained. Switch to small flow rate operation. As a result, it is possible to avoid a situation where the flow rate of the liquid is too small (liquid shortage situation) during power transfer.
  • the control unit accepts an instruction signal for starting ablation only when it is determined that the standby flow rate operation after the liquid flow rate is very small.
  • the ablation catheter for example, the lumen for flowing liquid
  • the control unit starts the power supply operation after switching from the standby flow operation to the small flow operation when the instruction signal is received.
  • the control unit when the control unit stops the power supply operation, the control unit shifts to the standby flow rate operation after the second standby time has elapsed since the power supply operation stopped. It is desirable to do so. In such a configuration, the occurrence of insufficient cooling due to the liquid due to the high temperature state continuing for a certain period even after the supply of power is stopped, and a more appropriate irrigation operation can be realized.
  • the ablation catheter has a temperature measurement mechanism near its distal end, and the control unit is connected to the power supply unit so that the temperature measured by the temperature measurement mechanism is maintained substantially constant. It is desirable to adjust the output power.
  • the actual output power is adjusted so that the temperature near the distal end of the ablation catheter (near the affected area during ablation) is kept substantially constant. That is, output power is supplied after appropriate power adjustment is performed based on the input set power.
  • the liquid supply section is provided in the liquid supply apparatus, and the power supply section and the control section are provided in a power supply apparatus that is separate from the liquid supply apparatus.
  • each device liquid supply device and power supply device
  • each of the liquid supply unit, the power supply unit, and the control unit may be provided in a single device.
  • the catheter system of the present invention when the transition from the high power state to the low power state is performed, if the low power state continues for the first waiting time during the transition, the large flow operation is performed in the first state. Since the switching to the small flow rate operation is performed after the standby time is maintained, it is possible to avoid the occurrence of a liquid shortage situation during power transfer. Therefore, an appropriate irrigation operation can be performed during ablation.
  • FIG. 1 is a block diagram schematically illustrating an overall configuration example of a catheter system according to an embodiment of the present invention. It is a schematic diagram showing the detailed structural example of the ablation catheter shown in FIG. It is a schematic diagram showing an example of the relationship between the actually measured electric power state and the flow volume operation
  • FIG. 1 is a block diagram schematically showing an example of the entire configuration of a catheter system (catheter system 5) according to an embodiment of the present invention.
  • the catheter system 5 is a system used for treating arrhythmia or the like in a patient (patient 9 in this example), and includes an ablation catheter 1, a liquid supply device 2, a power supply device 3, and a counter electrode plate 4. That is, in the catheter system 5 of the present embodiment, the liquid supply device 2 and the power supply device 3 are configured separately.
  • the ablation catheter 1 is an electrode catheter that is inserted into the body of a patient 9 through a blood vessel and performs treatment such as arrhythmia by ablating the affected area.
  • the ablation catheter 1 also has an irrigation mechanism that causes a predetermined irrigation liquid (such as physiological saline) to flow out (inject) from the distal end P1 side during such ablation.
  • a predetermined irrigation liquid such as physiological saline
  • the catheter system 5 is a catheter system with such an irrigation mechanism.
  • FIG. 2 schematically shows a schematic configuration example 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, through-hole) is formed so as to extend along its own axial direction, 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.
  • the lumen for flowing the irrigation liquid L is formed in the shaft 11 so as to extend along the axial direction.
  • a mechanism (temperature measurement mechanism) for measuring the temperature near the tip P1 (around the affected area) is provided near the tip P1 of the shaft 11.
  • 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 distal end P1 measured in this manner is supplied from the ablation catheter 1 to the power supply device 3 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 near the tip P1 of the shaft 11, as shown in the enlarged view near the tip P1 in FIG. 2, a plurality of electrodes (here, three ring electrodes 111a, 111b, 111c and one tip electrode 112) 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 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.
  • 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. Further, from the vicinity of the tip of the tip electrode 112, the irrigation liquid L described above flows out as indicated by the arrow in FIG.
  • Such ring-shaped electrodes 111a, 111b, 111c and the tip electrode 112 are electrically conductive, such as aluminum (Al), copper (Cu), stainless steel (SUS), gold (Au), platinum (Pt), respectively. It is comprised with the metal material with favorable property. 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 preferably 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 liquid supply device 2 is a device that supplies the irrigation liquid L described above to the ablation catheter 1, and has a liquid supply portion 21 as shown in FIG.
  • the liquid supply unit 21 supplies the liquid L having a flow rate defined by a control signal CTL2 described later to the ablation catheter 1 as needed.
  • This liquid supply part 21 is comprised including the liquid pump etc., for example.
  • the power supply device 3 supplies power during ablation (for example, output power Pout composed of radio frequency (RF)) to the ablation catheter 1 and the counter electrode plate 4 and also supplies the liquid L in the liquid supply device 2. It is a device that controls. As illustrated in FIG. 1, the power supply device 3 includes an input unit 31, a power supply unit 32, a voltage measurement unit 33, a current measurement unit 34, a control unit 35, and a display unit 36.
  • ablation for example, output power Pout composed of radio frequency (RF)
  • RF radio frequency
  • the input unit 31 is a part for inputting various setting values and an instruction signal for instructing a predetermined operation to be described later.
  • threshold power Pth threshold power Pth
  • target temperature Tt liquid flow rate Fh during “HIGH” flow rate operation
  • LOW Examples of the liquid flow rate Fl during the flow rate operation
  • the liquid flow rate Fst during the “Standby” flow rate operation and various waiting times.
  • These set values are input by an operator (for example, an engineer) of the power supply device 3.
  • the threshold power Pth is not input by the operator, but may be set in the power supply device 3 in advance at the time of shipment of the product.
  • the set value input by the input unit 31 is supplied to the control unit 35.
  • the set power Ps is shown as a representative.
  • Such an input unit 31 is configured using, for example, a predetermined dial, button, touch panel, or the like.
  • the power supply unit 32 is a part that supplies the above-described output power Pout to the ablation catheter 1 and the counter electrode plate 4 in accordance with a control signal CTL1 described later.
  • a power supply part 32 is comprised using the predetermined power supply circuit (for example, switching regulator etc.).
  • the output power Pout is high frequency power, the frequency is, for example, about 450 kHz to 550 kHz (for example, 500 kHz).
  • the voltage measurement unit 33 is a part that measures (detects) the voltage at the output power Pout output from the power supply unit 32 as needed, and is configured using a predetermined voltage detection circuit. The voltage (measured voltage Vm) measured by the voltage measuring unit 33 in this way is output to the control unit 35.
  • the current measurement unit 34 is a part that measures the current in the output power Pout output from the power supply unit 32 as needed, and is configured using a predetermined current detection circuit.
  • the current (measured current Im) measured by the current measuring unit 34 in this way is output to the control unit 35.
  • the control unit 35 is a part that controls the entire power supply device 3 and performs predetermined arithmetic processing, and is configured using, for example, a microcomputer. Specifically, the control unit 35 first has a function of calculating an actually measured power Pm (corresponding to the power value of the output power Pout) described below. Further, the control unit 35 uses the control signal CTL1 to control the supply operation of the output power Pout in the power supply unit 32 (power supply control function), and uses the control signal CTL2 to control the liquid L in the liquid supply unit 21. And a function for controlling the supply operation (liquid supply control function).
  • the control unit 35 generates the control signal CTL1 based on the above-described measured temperature information Tm, and outputs the control signal CTL1 to the power supply unit 32, thereby adjusting (fine adjustment) the magnitude of the output power Pout.
  • the control unit 35 generates the control signal CTL1 based on the above-described measured temperature information Tm, and outputs the control signal CTL1 to the power supply unit 32, thereby adjusting (fine adjustment) the magnitude of the output power Pout.
  • Tm 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 magnitude of the output power Pout is adjusted so as to become (preferably equal).
  • control unit 35 performs control so that the value of the output power Pout 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 Pout 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 Pout (measured power Pm) do not necessarily match.
  • the liquid supply control function described above is as follows. That is, the control unit 35 controls the flow rate of the liquid L by generating the control signal CTL2 based on the actual measurement power Pm obtained by the above-described method and outputting the control signal CTL2 to the liquid supply unit 21. To do.
  • the display unit 36 is a part (monitor) that displays various information and outputs it to the outside.
  • Examples of the information to be displayed include the above-described various set values (set power Ps and the like) input from the input unit 31, the measured power Pm supplied from the control unit 35, and the measured temperature supplied from the ablation catheter 1.
  • Information Tm etc. are mentioned.
  • 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 part 36 is comprised using the display (For example, a liquid crystal display, a CRT (Cathode
  • Counter electrode 4 For example, as shown in FIG. 1, the counter electrode plate 4 is used while being attached to the body surface of the patient 9 during ablation. As will be described in detail later, high-frequency energization is performed between the counter electrode plate 4 and the electrode of the electrode catheter 1 inserted into the body of the patient 9 during ablation.
  • power (output power Pout) at the time of ablation is supplied to the ablation catheter 1 and the counter electrode 4 from the power supply device 3 (power supply unit 32).
  • the counter electrode 4 mounted on the body surface of the patient 9 and the electrodes of the ablation catheter 1 inserted into the body of the patient 9 (the tip electrode 112 and the ring electrode 111a, 111b, 111c).
  • a site to be treated (treatment part) in the patient 9 is selectively ablated, and percutaneous therapy such as arrhythmia is performed.
  • irrigation liquid L is supplied from the liquid supply device 2 (liquid supply unit 21) to the ablation catheter 1. Further, the power supply device 3 (the control unit 35) controls the supply operation of the liquid L in the liquid supply device 2 using the control signal CTL2. Thereby, the liquid L for irrigation spouts from the vicinity of the front-end
  • the value of the output power Pout (actually measured power Pm) varies in linkage with the temperature near the tip P1 of the shaft 11 (actually measured temperature information Tm). Specifically, the value of the output power Pout is adjusted so that this temperature becomes substantially equal to the target temperature Tt. That is, the value of the actually measured power Pm changes at any time according to the treatment status. For these reasons, in a catheter system with an irrigation mechanism, it is required to adjust the flow rate of the liquid according to the state of use and realize an appropriate irrigation operation.
  • the ablation operation is performed after adjusting (controlling) the flow rate of the irrigation liquid L as follows.
  • control operation of the output power Pout using the above-described measured temperature information Tm is omitted for the sake of simplicity.
  • FIG. 4 is a flowchart showing an example of the ablation operation of the present embodiment.
  • the “Standby” flow rate operation described above is started as follows (step S101). That is, when an instruction signal for starting the “Standby” flow rate operation is input to the control unit 35 via the input unit 31 by the operator of the power supply device 3, the control unit 35 performs the “Standby” flow rate operation.
  • the operation of the liquid supply unit 21 is controlled so as to be started.
  • the control unit 35 accepts an instruction signal for starting this ablation only when it is determined that the “Standby” flow rate operation has started. In other words, if it is determined that the “Standby” flow rate operation is not yet started, the control unit 35 causes the power supply unit 32 to start ablation even if such an instruction signal is input.
  • the control signal CTL1 is not output.
  • the ablation catheter 1 for example, the lumen for flowing the liquid L
  • the ablation catheter 1 can be filled with the liquid L before the start of ablation.
  • the risk that blood flows into the inside from the distal end portion of the ablation catheter 1 (for example, the outflow hole of the liquid L) and the thrombus is clogged inside (for example, the lumen) is avoided.
  • step S105 the ablation of the treatment portion by the “LOW” flow rate operation is started based on the principle described above.
  • the waiting time at the start of ablation is preferably about 1 to 10 seconds, and 5 seconds is a preferable example.
  • control unit 35 after switching from the “Standby” flow rate operation to the “LOW” flow rate operation, control is performed so that the supply operation of the output power Pout at the time of ablation in the power supply unit 32 is started.
  • the actual measurement voltage Vm and the actual measurement current Im are measured, and the actual measurement power Pm is calculated using the arithmetic expression (1).
  • the power Pm is measured (step S106).
  • control unit 35 compares the values of the actually measured power Pm and the threshold power Pth thus obtained. Specifically, in this example, it is determined whether or not the actually measured power Pm is a value (Pm ⁇ Pth) equal to or greater than the threshold power Pth (step S107).
  • step S107 N, in the low power state
  • the control unit 35 determines whether an instruction signal for stopping the output of the output power Pout is input via the input unit 31 by the operator of the power supply device 3 (step S109).
  • step S109 When it is determined that an output stop instruction signal has been input (step S109: Y), the control unit 35 outputs a control signal CTL1 to that effect to the power supply unit 32, thereby outputting the output power Pout (high frequency output). ) Is stopped (step S110).
  • a predetermined power supply stop standby time second standby time
  • the control unit 35 shifts from the “LOW” flow rate operation to the “Standby” flow rate operation.
  • the entire ablation operation shown in FIG. 4 is completed.
  • the standby time when the power supply is stopped is preferably about 1 to 5 seconds, and is 2 seconds if a suitable example is shown.
  • step S109: N If it is determined that the above output stop instruction signal is not input (step S109: N), the process returns to step S106, and the measured power Pm is measured again.
  • the transition of the measured power Pm from the low power state to the high power state is different from the transition from the high power state to the low power state described later.
  • the control unit 35 quickly switches from the “LOW” flow rate operation to the “HIGH” flow rate operation (without waiting for the elapse of a predetermined flow rate operation switching standby time to be described later). In this way, by immediately switching to the “HIGH” flow rate operation, it is possible to avoid a situation where the liquid flow rate is too low (liquid shortage situation) during the transition from the low power state to the high power state. .
  • the measured power Pm is measured again in the voltage measuring unit 33, the current measuring unit 34, and the control unit 35 (step S113). Then, the control unit 35 determines again whether or not the actually measured power Pm is a value (Pm ⁇ Pth) equal to or greater than the threshold power Pth (step S114).
  • control unit 35 performs control so that the “HIGH” flow rate operation is continued (step S115). Then, similarly to step S109 described above, control unit 35 determines whether or not an instruction signal for stopping output of output power Pout has been input (step S116). If it is determined that an output stop instruction signal has been input (step S116: Y), the control unit 35 outputs a control signal CTL1 to that effect to the power supply unit 32, thereby outputting the output power Pout (high frequency output). ) Is stopped (step S117).
  • control unit 35 performs control so as to shift from the “HIGH” flow rate operation to the “Standby” flow rate operation after the standby time at the time of power supply stop has elapsed (step S1). S118), the entire ablation operation shown in FIG. 4 is completed.
  • step S116: N If it is determined that the above output stop instruction signal is not input (step S116: N), the process returns to step S113, and the measured power Pm is measured again.
  • step S114 If it is determined in the above-described step S114 that Pm ⁇ Pth (step S114: N, in the low power state), the control unit 35 next (Pm ⁇ Pth) state (low power) It is determined whether or not the (state) has continued for a predetermined time (predetermined waiting time for switching the predetermined flow rate operation; first waiting time) (step S119). If it is determined that the waiting time for switching the flow rate operation has not been continued (step S119: N), the process proceeds to step S115 described above, and the control unit 35 performs control so that the “HIGH” flow rate operation is continued. .
  • the waiting time for switching the flow rate operation is preferably about 1 to 10 seconds, and 5 seconds is shown as a suitable example.
  • the control unit 35 controls the flow rate operation of the liquid L as follows. That is, when the low power state continues at the above-described waiting time for switching the flow rate operation at the time of transition, the control unit 35 maintains the “HIGH” flow rate operation for the waiting time for switching the flow rate operation, and then performs the “LOW” flow rate operation. Switch to. In other words, after waiting for the elapse of such a waiting time for switching the flow rate operation, the “HIGH” flow rate operation is switched to the “LOW” flow rate operation. This avoids the occurrence of a situation where the flow rate of the liquid is too small (liquid shortage situation) during the transition from the high power state to the low power state.
  • the risk when the liquid flow rate F is too small compared to the risk when the liquid flow rate F is too large (the temperature of the treatment portion is lowered and the treatment during the treatment is hindered). Since the effect of cooling the treatment portion and improving blood retention is insufficient (the problem is serious), the control is performed as described above. That is, in consideration of the magnitude relationship of such risks, a period in which the liquid flow rate F is high while maintaining a period in which the liquid flow rate F is relatively high when the state of the actually measured power Pm shifts. Therefore, the liquid flow rate F is switched to be relatively small after the elapse of the waiting time for switching the flow rate operation.
  • Step S119: N When not continuing (corresponding to the case of Step S119: N), it becomes as follows. That is, in such a case, the control unit 35 does not switch from the “HIGH” flow rate operation to the “LOW” flow rate operation (continues the “HIGH” flow rate operation). As a result, as shown in the example in FIG. 6, an appropriate irrigation operation is realized even in a situation where the value of the measured power Pm is changing with time so as to rise and fall near the threshold power Pth. .
  • the control unit 35 quickly switches from the “LOW” flow rate operation to the “HIGH” flow rate operation when shifting from the low power state to the high power state of the actually measured power Pm.
  • the ⁇ HIGH '' flow rate operation is maintained after the standby time for switching the flow rate operation is maintained. Since the operation is switched to the “LOW” flow rate operation, it is possible to avoid the occurrence of a liquid shortage during power transfer. Therefore, an appropriate irrigation operation can be performed during ablation.
  • control unit 35 adjusts the output power Pout so that the temperature measured by the temperature measurement mechanism in the ablation catheter 1 is kept substantially constant, the following effects can also be obtained. That is, it is possible to supply the actual output power Pout after performing appropriate power adjustment based on the input set power Ps.
  • the liquid supply device 2 and the power supply device 3 are configured as separate bodies, it is possible to arrange each device individually according to the usage situation, so that the catheter system 5 as a whole is convenient. Can be improved. Specifically, for example, as shown in FIG. 1, the liquid supply device 2 is relatively disposed near the patient 9, so that the liquid supply tube connecting the liquid supply device 2 and the ablation catheter 1 is shortened. This makes it easier for doctors to operate. At the same time, the power supply device 3 is relatively distant from the patient 9 so that an engineer or the like can easily operate. In this way, it is possible to arrange the apparatus according to the usage situation.
  • FIG. 7 is a block diagram schematically showing an example of the overall configuration of a catheter system (catheter system 5A) according to a modification of the above embodiment.
  • the catheter system 5A of this modification is also a system used in the treatment of arrhythmia or the like in the patient 9, and includes an ablation catheter 1, a control device 6, and a counter electrode plate 4.
  • the control device 6 is configured as a single device by integrating the liquid supply device 2 and the power supply device 3 described in the above embodiment, and each block included in the liquid supply device 2 and the power supply device 3 is provided. is doing. That is, the control device 6 includes a liquid supply unit 21, an input unit 31, a power supply unit 32, a voltage measurement unit 33, a current measurement unit 34, a control unit 35, and a display unit 36.
  • the functions of the liquid supply device 2 and the power supply device 3 are integrated to form a single device (control device 6). It is configured.
  • the liquid supply unit 21, the input unit 31, the power supply unit 32, the voltage measurement unit 33, the current measurement unit 34, the control unit 35, and the display unit 36 are each provided in the control device 6 that is a single device. Yes.
  • the functions of the liquid supply device 2 and the power supply device 3 are integrated to form a single device (control device 6). Simplification can be realized.
  • each layer and each member described in the above embodiments are not limited, and other materials may be used.
  • the structure of the ablation catheter 1 (shaft 11) was specifically mentioned and demonstrated, it is not necessary to necessarily provide all the members and you may further provide other members.
  • a leaf spring that can be deformed in the bending direction may be provided inside the shaft 11 as a swinging member.
  • the configuration of the electrodes in the shaft 11 is not limited to those described in the above embodiments.
  • the ablation catheter of the type in which the shape near the tip P1 of the shaft 11 changes in one direction according to the operation of the operation unit 12 has been described as an example, but the present invention is not limited thereto. . That is, the present invention can be applied to, for example, an ablation catheter of a type in which the shape of the shaft 11 near the tip P1 changes in both directions according to the operation of the operation unit 12, and in this case, the operation wire Will be used. The present invention can also be applied to an ablation catheter of a type in which the shape near the tip P1 of the shaft 11 is fixed. In this case, the operation wire, the rotating plate 122, and the like are unnecessary. Become. That is, the operation unit is configured only by the handle 121.
  • the block configurations of the liquid supply device 2 and the power supply device 3 have been specifically described, but it is not always necessary to include all the blocks described in the above-described embodiment and the like. Other blocks may be further provided. Further, the entire catheter system may further include other devices in addition to the devices described in the above embodiments. Specifically, for example, a relay for supplying the liquid may be further provided on the liquid supply line between the liquid supply unit 21 (the liquid supply device 2 or the control device 6) and the ablation catheter 1.
  • each process in the ablation operation has been specifically described with reference to a flowchart. However, it is not always necessary to perform all the processes described in the above-described embodiment. The above process may be further performed. Specifically, at least one of the “Standby” flow rate operation and the control operation of the output power Pout using the actually measured temperature information Tm described in the above-described embodiment and the like may not be performed depending on circumstances.

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Abstract

La présente invention concerne un système de cathéter qui est capable d'effectuer une opération d'irrigation adaptée. Le système de cathéter (5) comprend : un cathéter d'ablation (1) ayant un mécanisme d'irrigation ; une unité d'alimentation électrique (32) qui fournit de l'électricité au cathéter d'ablation (1) pendant l'ablation ; une unité d'alimentation de fluide (21) pour fournir un fluide d'irrigation au cathéter d'ablation (1) ; et une unité de commande (35). L'unité de commande (35) commande de manière à obtenir un fonctionnement à haut débit lorsque la puissance mesurée (Pm) pendant l'ablation est dans un état à haute puissance à ou au-dessus d'un seuil de puissance (Pth), et commande de manière à obtenir un fonctionnement à bas débit lorsque la puissance mesurée (Pm) est dans un état de basse puissance au-dessous du seuil de puissance (Pth). De plus, l'unité de commande (35) bascule rapidement du fonctionnement à bas débit vers le fonctionnement à haut débit lors d'une transition de l'état de basse puissance vers l'état de haute puissance et, lors d'une transition de l'état de haute puissance vers l'état de basse puissance, si, lors de la transition, l'état de basse puissance est maintenu pendant un premier temps d'attente, l'unité de commande (35) bascule vers le fonctionnement à bas débit après avoir maintenu un fonctionnement à haut débit pendant le premier temps d'attente.
PCT/JP2013/075888 2013-02-28 2013-09-25 Système de cathéter WO2014132476A1 (fr)

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WO2020174650A1 (fr) * 2019-02-28 2020-09-03 日本ライフライン株式会社 Système de cathéter
WO2020174651A1 (fr) * 2019-02-28 2020-09-03 日本ライフライン株式会社 Système de cathéter

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TWI564042B (zh) 2017-01-01
JP2014166237A (ja) 2014-09-11
CN104822335A (zh) 2015-08-05
TW201433324A (zh) 2014-09-01
JP5757586B2 (ja) 2015-07-29
KR20150113075A (ko) 2015-10-07
CN104822335B (zh) 2017-12-19

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