WO2014132463A1

WO2014132463A1 - Catheter system

Info

Publication number: WO2014132463A1
Application number: PCT/JP2013/071648
Authority: WO
Inventors: 小島　康弘; 修一堀内
Original assignee: 日本ライフライン株式会社
Priority date: 2013-02-28
Filing date: 2013-08-09
Publication date: 2014-09-04
Also published as: CN104822336A; JP2014166236A; CN104822336B; KR20150113076A; JP5737765B2; TWI562796B; TW201433325A; KR101652659B1

Abstract

Provided is a catheter system capable of performing a suitable irrigation operation. The catheter system (5) comprises: an ablation catheter (1) having an irrigation mechanism; a power supply unit (32) that supplies electrical power to the ablation catheter (1) during ablation; a fluid supply unit (21) that supplies irrigation fluid to the ablation catheter (1); and a control unit (35). The control unit (35) controls so as to achieve a high flowrate operation when a set power (Ps) during ablation is in a high-power state at or above a threshold power (Pth), and controls so as to achieve a low flowrate operation when a set power (Ps) is in a low-power state below the threshold power (Pth). Furthermore, the control unit (35) quickly switches from a low flowrate operation to a high flowrate operation upon a transition from the low-power state to the high-power state and, upon a transition from the high-power state to the low-power state, if at the time of transition the low-power state has continued for a first standby time, the control unit (35) switches to a low flowrate operation after maintaining a high flowrate operation for the first standby time.

Description

Catheter system

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. In such an electrode catheter, generally, 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. In addition to the type in which the shape of the tip is arbitrarily changed according to the operation as described above, there is a type in which the shape near the tip is fixed.

By the way, 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.

Therefore, as a technique for solving such a problem, there is a catheter system including an irrigation mechanism for flowing a liquid such as physiological saline during ablation (for example, Patent Documents 1 and 2). In this catheter system, when the liquid flows out from the distal electrode of the ablation catheter at the time of ablation, it is possible to prevent the affected part from being cooled and to prevent thrombus formation.

JP 2006-239414 A JP 2012-176119 A

By the way, in the above catheter system with an irrigation mechanism, when the flow rate of the liquid discharged to the treatment portion is too large, the temperature of the treatment portion is lowered, and there is a possibility that the treatment at the time of treatment may be hindered. Moreover, if the liquid enters the body too much, the burden on the patient may increase. On the other hand, if the flow rate of the liquid is too small, the effect of cooling the treatment portion and improving blood retention may be insufficient. For these reasons, it is required to adjust (manage) the flow rate of the liquid according to the use situation and to realize an appropriate irrigation operation.

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 set power at the time of ablation is equal to or higher than the threshold power, while the set 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. Further, when transitioning from the low power state to the high power state, while quickly switching from the small flow rate operation to the large flow rate operation, when transitioning from the high power state to the low power state, When the low power state continues for the first standby time at the time of the transition, the large flow rate operation is switched to the small flow rate operation after the first standby time is maintained.

In the catheter system of the present invention, 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. On the other hand, 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.

In the catheter system according to the present invention, it is desirable that 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. . When configured in this manner, the ablation catheter (for example, the lumen for flowing liquid) can be filled with liquid before the start of ablation. Thereby, for example, the risk that blood flows into the inside from the distal end portion (for example, the liquid outflow hole) of the ablation catheter and the inside (for example, the lumen) is clogged with blood clots is avoided. In this case, when the control unit receives the instruction signal, the control unit starts the power supply operation after switching from the standby flow operation to the small flow operation or the large flow operation. It is more desirable to do so. When configured in this way, since the liquid generally requires a supply (arrival) time compared to the electric power, the occurrence of a liquid shortage due to such a difference in the supply time is avoided, and a more appropriate irrigation operation is performed. It becomes feasible.

In the catheter system of the present invention, 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.

In the catheter system of the present invention, 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. When configured in this way, 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.

In the catheter system of the present invention, 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. Is possible. When configured in this manner, each device (liquid supply device and power supply device) can be individually arranged in accordance with the use situation, so that the convenience of the entire system is improved. Alternatively, each of the liquid supply unit, the power supply unit, and the control unit may be provided in a single device. When configured in this way, simplification of the configuration of the entire system is realized.

According to 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.

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 set electric power state and the flow volume operation | movement of a liquid. It is a flowchart showing an example of operation | movement of the catheter system shown in FIG. It is a mimetic diagram showing an example of control operation at the time of transfer of flow operation. It is a schematic diagram showing the other example of control operation at the time of transfer of flow operation. It is a block diagram showing typically the example of whole composition of the catheter system concerning the modification of the present invention.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The description will be given in the following order.
1. Embodiment (example in which a liquid supply device and a power supply device are provided separately)
2. Modified example (example in which each function is integrated and provided as a single device)
3. Other variations

<Embodiment>
[overall structure]
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.

(Ablation catheter 1)
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. In other words, 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.

In addition to the lumen for inserting such various thin wires, the lumen for flowing the irrigation liquid L is formed in the shaft 11 so as to extend along the axial direction. In addition, 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. Specifically, 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).

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. 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. 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.

(Liquid supply device 2)
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.

(Power supply 3)
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.

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. As various set values, details will be described later. For example, set power Ps (= maximum power in output power Pout), 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. However, for example, 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. Further, the set value input by the input unit 31 is supplied to the control unit 35. In FIG. 1, among these various set values, 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. Such a power supply part 32 is comprised using the predetermined power supply circuit (for example, switching regulator etc.). When 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).

First, the calculation function of the actually measured power Pm is as follows. That is, the control unit 35 calculates the measured power Pm as needed based on the measured voltage Vm output from the voltage measuring unit 33 and the measured current Im output from the current measuring unit 34. Specifically, the control unit 35 calculates the actually measured power Pm using the following arithmetic expression (1). The measured power Pm calculated by the control unit 35 in this way is output to the display unit 36 in this example.
Pm = (Vm × Im) (1)

Next, the power supply control function described above is as follows. That is, 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. To do. 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 magnitude of the output power Pout is adjusted so as to become (preferably equal).

Specifically, the 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. On the other hand, when the temperature near the tip P1 exceeds the target temperature Tt, control is performed so that the value of the output power Pout decreases. In this manner, 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.

Also, 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 set power Ps described above and outputting the control signal CTL2 to the liquid supply unit 21.

Specifically, the control unit 35 controls the flow rate of the liquid L (liquid flow rate F) based on the set power Ps, for example, as shown in FIG. That is, the liquid flow rate F defined in the control signal CTL2 is compared by comparing the values of the set power Ps and a predetermined threshold power Pth (for example, 31 W (Watt)) set in advance (in accordance with the comparison result). (The type of flow rate operation in the liquid supply unit 21) is set. Specifically, when the set power Ps is in a high power state where the set power Ps is equal to or greater than the threshold power Pth (Ps ≧ Pth), the liquid flow rate F is relatively high (“HIGH” where F = Fh). (Flow rate operation). On the other hand, in the low power state where the set power Ps is less than the threshold power Pth (Ps <Pth), the liquid flow rate F is relatively small (“LOW” flow rate operation where F = Fl (<Fh)). Control to be Further, in a predetermined case to be described later, control is performed so that the standby flow rate operation (F = Fst (0 <Fst <Fl) “Standby” flow rate operation) in which the liquid flow rate F is very small). Specific examples of the values of Fh, Fl, and Fst described above include Fh = 30 cc, Fl = 17 cc, and Fst = 2 cc, respectively. Details of such a liquid supply control function (control operation of the liquid flow rate F) will be described later (FIGS. 4 to 6).

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. However, 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 | Ray * Tube) display, an organic EL (Electro * Luminescence) display, etc.) by various systems.

(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.

[Action / Effect]
(A. Basic operation)
In the catheter system 5, the shaft 11 of the ablation catheter 1 is inserted into the body of the patient 9 through the blood vessel when treating arrhythmia or the like. At this time, according to the operation of the operation unit 12 by the operator, 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. Specifically, when the rotating plate 122 is rotated by the operator's finger along, for example, the rotation direction d1 indicated by the arrow in FIG. 2, an operation wire (not shown) in the shaft 11 moves to the proximal end side. Be pulled. As a result, the vicinity of the tip of the shaft 11 is curved along the direction d2 indicated by the arrow in FIG.

Here, 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). Thus, during the treatment of the above-described arrhythmia and the like, 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). By such high-frequency energization, a site to be treated (treatment part) in the patient 9 is selectively ablated, and percutaneous therapy such as arrhythmia is performed.

During such ablation, 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 | tip of the front-end | tip electrode 112 in the ablation catheter 1 (refer the arrow in FIG. 2). As a result, it is avoided that the temperature of the treatment portion during the ablation increases excessively, causing damage and thrombus sticking to the treatment portion (blood retention is improved).

However, when the flow rate of the liquid L discharged to the treatment portion is too large, the temperature of the treatment portion is lowered and there is a possibility that the treatment at the time of treatment may be hindered. Moreover, if the liquid L enters the body too much, the burden on the patient may increase. On the other hand, when the flow rate of the liquid L is too small, there is a possibility that the effect of cooling the treatment portion and improving the blood retention will be insufficient. In particular, when the power at the time of ablation is high, the above-mentioned tendency is increased because tissue damage and thrombus due to excessive ablation are likely to occur. In addition, during actual ablation, the operator of the power supply device 3 changes the value of the set power Ps as needed according to the treatment status. That is, the set power Ps is not a fixed value but changes according to the situation. 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.

(B. Details of Ablation Operation)
Therefore, in the catheter system 5 of the present embodiment, the ablation operation is performed after adjusting (controlling) the flow rate of the irrigation liquid L as follows. Hereinafter, such an ablation operation will be described in detail. In the following description using FIG. 4, the 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. In this ablation operation, first, 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. As a result, a small amount of irrigation liquid L with a liquid flow rate F = Fst is released from the vicinity of the distal end of the distal electrode 112 in the ablation catheter 1 to the treatment portion.

Subsequently, when values of the set power Ps and the target temperature Tt at the time of ablation are input from the input unit 31 by the operator of the power supply device 3, these values are supplied to the control unit 35. Settings are made (step S102). Then, the operator sets (instructs) the start of ablation (cautery operation) from the input unit 31 (step S103). That is, an instruction signal for starting ablation is input to the control unit 35 via the input unit 31.

Here, it is desirable that 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. Thereby, the ablation catheter 1 (for example, the lumen for flowing the liquid L) can be filled with the liquid L before the start of ablation. As a result, for example, 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.

Next, the control unit 35 compares the values of the set power Ps and the threshold power Pth. Specifically, in this example, it is determined whether or not the set power Ps is a value (Ps ≧ Pth) that is equal to or greater than the threshold power Pth (step S104).

("LOW" flow rate operation)
Here, when it is determined that Ps <Pth (step S104: N, in the low power state), the control unit 35 performs a small flow rate operation (F = Control is performed so that the “LOW” flow rate operation that is Fl is started (step S105). Thereby, the liquid L with the liquid flow rate F = Fl is discharged from the vicinity of the distal end of the distal electrode 112 in the ablation catheter 1 to the treatment portion.

Next, after a predetermined ablation start waiting time has elapsed since the start of such a “LOW” flow rate operation, supply of output power Pout (for example, high frequency output) from the power supply unit 32 to the ablation catheter 1 and the counter electrode plate 4. Is started (step S106). Thereby, the ablation of the treatment portion by the low power state and the “LOW” flow rate operation is started on the principle described above. Here, the waiting time at the start of ablation is preferably about 1 to 10 seconds, and 5 seconds is a preferable example.

Thus, in the 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 following advantages are obtained. That is, since the liquid generally requires a supply time as compared with the electric power, the occurrence of the liquid shortage due to the difference in the supply time is avoided, and a more appropriate irrigation operation can be realized.

Subsequently, 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 S107). If it is determined that an output stop instruction signal has been input (step S107: 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 S108). Then, after a predetermined power supply stop standby time (second standby time) has elapsed after the supply of the output power Pout is stopped, the control unit 35 shifts from the “LOW” flow rate operation to the “Standby” flow rate operation. Control is performed (step S109), and the entire ablation operation shown in FIG. 4 is completed. Here, 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.

Thus, when stopping the power supply (supply of output power Pout) at the time of ablation in the control unit 35, after the standby time when the power supply is stopped after the supply operation of the output power Pout stops, “ The transition to “Standby” flow rate operation provides the following advantages: That is, even after the supply of the output power Pout is stopped, the occurrence of insufficient cooling due to the irrigation liquid L due to the high temperature state of the treatment part continuing for a certain period can be avoided, and a more appropriate irrigation operation can be realized. It becomes.

If it is determined that the output stop instruction signal is not input (step S107: N), the control unit 35 next again sets the value of the set power Ps to be equal to or greater than the threshold power Pth (Ps ≧ Pth). ) Is determined (step S110). If it is determined that Ps <Pth (step S110: N, in the low power state), the control unit 35 performs control so that the “LOW” flow rate operation is continued, and returns to step S107. On the other hand, when it is determined that Ps ≧ Pth (step S110: Y, in the high power state), the control unit 35 determines that the liquid flow rate F is relatively large from the current “LOW” flow rate operation. Control is performed so as to switch to the operation (“HIGH” flow rate operation in which F = Fh) (step S111). Thereby, the liquid L with the liquid flow rate F = Fh is discharged from the vicinity of the distal end of the distal electrode 112 in the ablation catheter 1 to the treatment portion. Thereafter, the process proceeds to step S114 described later.

Here, as shown in FIG. 5, for example, when the set power Ps is shifted from the low power state to the high power state, it 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. .

("HIGH" flow rate operation)
If it is determined in step S104 described above that Ps ≧ Pth (step S104: Y, high power state), the control unit 35 performs control so that the above-described “HIGH” flow rate operation is started. (Step S112). Thereby, the liquid L with the liquid flow rate F = Fh is discharged from the vicinity of the distal end of the distal electrode 112 in the ablation catheter 1 to the treatment portion.

Next, after the above-described waiting time at the start of ablation elapses after the start of the “HIGH” flow rate operation, supply of output power Pout (for example, high frequency output) from the power supply unit 32 to the ablation catheter 1 and the counter electrode plate 4. Is started (step S113). Thereby, the ablation of the treatment part by the high power state and the “HIGH” flow rate operation is started based on the principle described above. In addition, after the control unit 35 switches from the “Standby” flow rate operation to the “HIGH” flow rate operation, the control unit 35 performs control so that the supply operation of the output power Pout at the time of ablation in the power supply unit 32 is started. The same advantages as when operating at “LOW” flow rate are obtained.

Subsequently, the control unit 35 determines whether or not an instruction signal for stopping the output of the output power Pout is input in the same manner as in Step S107 described above (Step S114). If it is determined that an output stop instruction signal has been input (step S114: 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 S115). Then, after the supply of output power Pout stops, the 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). S116), the entire ablation operation shown in FIG. 4 is completed.

Even when the “HIGH” flow rate operation is performed in this way, when the supply of the output power Pout is stopped in the control unit 35, the standby time when the power supply is stopped after the supply operation of the output power Pout is stopped. After the elapse of time, it is shifted to “Standby” flow rate operation. As a result, the same advantages as those in the above-described “LOW” flow rate operation can be obtained.

If it is determined that the output stop instruction signal is not input (step S114: N), the control unit 35 next again sets the set power Ps to a value equal to or greater than the threshold power Pth (Ps ≧ Pth). ) Is determined (step S117). If it is determined that Ps ≧ Pth (step S117: Y, high power state), the control unit 35 returns to step S114 while performing control so that the “HIGH” flow rate operation is continued.

On the other hand, when it is determined that Ps <Pth (step S117: N, in the low power state), the control unit 35 then presets this (Ps <Pth) state (low power state). It is then determined whether or not the predetermined time (predetermined waiting time when switching the flow rate operation; first waiting time) has continued (step S118). When it is determined that the waiting time for switching the flow rate operation has not been continued (step S118: N), the process returns to step S114 described above. Here, 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.

On the other hand, if it is determined that the standby time for switching the flow rate operation has continued (step S118: Y), the control unit 35 controls to switch from the current “HIGH” flow rate operation to the “LOW” flow rate operation. (Step S119). As a result, the liquid L having the liquid flow rate F = Fl is discharged from the vicinity of the distal end of the distal electrode 112 in the ablation catheter 1 to the treatment portion. Thereafter, the process proceeds to step S107 described above.

Here, as shown in FIG. 6, for example, when the set power Ps shifts from the high power state to the low power state, it differs from the above-described transition from the low power state to the high power state. 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.

Specifically, first, when the operator of the power supply device 3 accidentally decreases the set power Ps (when the set power Ps is accidentally switched from the high power state to the low power state). ) Does not immediately switch to “LOW” flow rate operation. Therefore, occurrence of a liquid shortage due to such an erroneous setting is avoided.

In addition, the risk (treatment portion) 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 treatment is hindered). The above-described control is performed because the effect of cooling the blood and improving blood retention is insufficient (the problem is serious). That is, in consideration of the magnitude relationship of such risks, the period during which the liquid flow rate F is relatively high during the transition of the set power Ps is maintained, while the period during which the liquid flow rate F is high is long. In order not to be too much, the liquid flow rate F is switched to be relatively small after the waiting time at the time of switching the flow rate operation.

Note that, for example, as indicated by the alternate long and short dash line in FIG. 6 and the “x” mark, even during the transition from the high power state to the low power state, the low power state during the transition is the waiting time for switching the flow rate operation. When it does not continue (corresponding to the case of step S108: 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 set power Ps changes with time so as to increase and decrease near the threshold power Pth. .

As described above, in the present embodiment, the control unit 35 quickly switches from the “LOW” flow rate operation to the “HIGH” flow rate operation when the set power Ps shifts from the low power state to the high power state. When transitioning from the high power state to the low power state, if the low power state continues for the standby time when switching to the flow rate operation at the time of transition, 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.

In addition, since the 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.

Furthermore, since 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.

<Modification>
Then, the modification of the said embodiment is demonstrated. In addition, the same code | symbol is attached | subjected to the same thing as the component in embodiment, and description is abbreviate | omitted suitably.

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.

As described above, in the catheter system 5A of this modification, unlike the catheter system 5 of the above-described embodiment, 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. In other words, 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.

Also in this modified example having such a configuration, basically the same effect can be obtained by the same operation as in the above embodiment. That is, it is possible to avoid the occurrence of a liquid shortage during power transfer, and to perform an appropriate irrigation operation during ablation.

In particular, in this modification, 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.

<Other variations>
While the present invention has been described with reference to the embodiments and modifications, the present invention is not limited to these embodiments and the like, and various modifications can be made.

For example, the materials and the like of each layer and each member described in the above embodiments are not limited, and other materials may be used. Moreover, in the said embodiment, although 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. Specifically, for example, a leaf spring that can be deformed in the bending direction may be provided inside the shaft 11 as a swinging member. Further, the configuration of the electrodes in the shaft 11 (arrangement, shape, number, and the like of the ring-shaped electrode and the tip electrode) is not limited to those described in the above embodiments.

In the above-described embodiment and the like, 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.

Furthermore, in the above-described embodiment and the like, 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.

In addition, in each of the above-described embodiments, 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.

Claims

An ablation catheter having an irrigation mechanism;
A power supply for supplying power during ablation to the ablation catheter;
A liquid supply unit for supplying irrigation liquid to the ablation catheter;
A control unit that controls the power supply operation in the power supply unit and the liquid supply operation in the liquid supply unit, respectively.
The controller is
In the high power state where the set power during the ablation is equal to or higher than the threshold power, the liquid is controlled so that the flow rate of the liquid is relatively large.
In the low power state where the set power is less than the threshold power, the liquid flow rate is controlled to be a relatively small flow rate operation, and
When transitioning from the low power state to the high power state, while quickly switching from the small flow rate operation to the large flow rate operation,
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 small flow rate operation is maintained after the first standby time is maintained. A catheter system that switches to flow operation.
2. The catheter system according to claim 1, wherein the control unit receives an instruction signal for starting the ablation only when it is determined that the standby flow operation is started after the liquid flow rate is very small.
The catheter system according to claim 2, wherein when the instruction signal is received, the control unit starts the power supply operation after switching from the standby flow operation to the small flow operation or the large flow operation.
When the control unit stops the power supply operation, after the second standby time has elapsed since the power supply operation stopped, the control unit switches to a standby flow rate operation in which the liquid flow rate is very small. The catheter system according to any one of claims 1 to 3, wherein the catheter system is transferred.
The ablation catheter has a temperature measurement mechanism near its tip,
The catheter according to any one of claims 1 to 4, wherein the control unit adjusts output power from the power supply unit so that the temperature measured by the temperature measurement mechanism is maintained substantially constant. system.
The liquid supply unit is provided in the liquid supply device,
The catheter system according to any one of claims 1 to 5, wherein the power supply unit and the control unit are each provided in a power supply device that is separate from the liquid supply device.
The catheter system according to any one of claims 1 to 5, wherein the liquid supply unit, the power supply unit, and the control unit are each provided in a single device.