JP4618237B2 - Ablation catheter system with balloon with adjustable temperature rise time - Google Patents

Description

  The present invention relates to a catheter and a system having a balloon-equipped catheter having a balloon capable of heating and treating a predetermined part of a human body by heating with power supply in the vicinity of the distal end thereof.

As an ablation catheter with a balloon, for example, Patent Literature 1 describes an ablation catheter with a balloon for pulmonary vein electrical isolation for treating cardiac arrhythmia. When pulmonary veins are electrically isolated using such an ablation catheter with a balloon, as shown in FIG. 10, the expandable / deflated balloon 52 disposed on the distal end side of the catheter 51 is percutaneously lowered. The balloon 52 is introduced into the vena cava QA and pierced through the atrial septum Hw from the right atrium Ha of the heart HA while being pushed by the catheter 51 to reach the left atrium Hb. The inside of the balloon is filled with liquid and expanded. Thereafter, when electric power is supplied from the high-frequency generator 55 between the balloon inner electrode 53 and the balloon outer electrode 54 so that the temperature inside the balloon becomes a predetermined temperature by a temperature sensor capable of monitoring the temperature inside the balloon, the heated balloon causes the pulmonary vein Qa to flow. The annular peripheral edge is cauterized as a whole. Following cauterization of the pulmonary vein opening Qa, cauterization of the remaining three pulmonary vein openings Qb to Qd opened on the inner wall of the left atrium Hb is sequentially performed in the same manner. All the four pulmonary veins are electrically isolated by cauterizing the annular peripheral edge of each pulmonary vein opening Qa to Qd. That is, the electrical signal causing arrhythmia is interrupted, and the cardiac arrhythmia is almost eliminated.
However, in the conventional ablation catheter with a balloon, when the internal volume of the balloon is small, the time for the balloon surface temperature to reach the specified temperature is shortened. When the balloon surface temperature reaches the set temperature in a short time, the burden on the patient is not small. Furthermore, if the high-frequency output increases instantaneously, the temperature of the liquid in the balloon rises before the temperature sensor in the balloon detects the temperature, and the liquid in the balloon may become higher than the set temperature. is there. The above phenomenon becomes more conspicuous as the position of the temperature sensor and the electrode are more distant from each other in the balloon, and should be avoided as long as there is a slight time lag even if the position of the temperature sensor and the position of the electrode are close or installed at the same place. Is difficult.
In an ablation catheter with a balloon, treatment is performed with the pulmonary vein opening blocked with a balloon, so it is not preferable to block the pulmonary vein for a long time. When the internal volume of the balloon is large, it takes a long time for the balloon surface temperature to reach the specified temperature, and the treatment time for occluding the pulmonary veins may become long, which may put a burden on the patient.
That is, in order to reduce the burden on the patient, there is a need for a system that adjusts the time to reach the balloon surface temperature in any internal volume balloon.
JP 2002-78809 (all pages of detailed explanation)

  It is an object of the present invention to provide a system that adjusts the time to reach the balloon surface temperature regardless of the inner volume of the balloon.

  In order to achieve the above-described problems, the present invention has the following configuration.

  1. A catheter with a balloon comprising a catheter shaft, a balloon attached to the catheter shaft, an electrode in the balloon and a temperature sensor in the balloon attached to the inside of the balloon, a liquid supply path for supplying a liquid to the inside of the balloon, and the inside of the balloon An ablation catheter system with a balloon having means for supplying electric power to the electrode to raise the temperature of the balloon surface to a set temperature, and adjusting the time until the balloon surface temperature is reached according to the internal volume of the balloon. Ablation catheter system with balloon, characterized in that it has possible means.

  2. The means for adjusting the time to reach the balloon surface temperature is a means for changing the rate of increase of the power supply or a combination of means for changing the rate of increase of the power supply and means for changing the power upper limit value. 2. The ablation catheter system with a balloon as described in 1 above.

3. ^{3. The} ablation catheter system with a balloon according to the above 1 or 2, wherein an inner volume of the balloon is 25000 mm ³ to 250,000 mm ³ and an average rate of increase in the power supply is 5 W to 10 W per second. .

  4). 4. The ablation catheter system with a balloon according to any one of 1 to 3, which has a function of transmitting an abnormality by an alarm or a display when the balloon surface temperature set within a set time is not reached.

  According to the ablation catheter system with a balloon according to the present invention, the time to reach the balloon surface temperature set according to the difference in the inner volume of the balloon can be adjusted. It is possible to increase the balloon surface temperature in accordance with the sensitivity of a certain patient. This makes it possible to provide a procedure that places the least burden on the patient. Furthermore, by slowing the rate of increase in power supply, it is possible to prevent the phenomenon that the liquid in the balloon becomes hotter than the temperature set by the instantaneous increase in high-frequency output.

  A preferred embodiment of the present invention will be described with reference to the drawings.

  FIG. 1 shows the configuration of a bipolar balloon catheter system according to this embodiment. In the balloon-equipped catheter 1, the balloon 2 is disposed near the distal end of the catheter shaft 3.

  The balloon-equipped catheter 1 has a length of about 1 m to 1 m 60 cm, and is used by being inserted into the body, particularly into a blood vessel. As the material of the catheter shaft 3, polyamide resin, polyvinyl chloride resin, polyimide resin, fluororesin, polyurethane resin and the like are used, but are not limited thereto. The length of the catheter shaft 3 is about 90 cm to 1 m50 cm, and the outer diameter is about 3 mm to 6 mm.

  As the material of the balloon 2, a stretchable material having excellent antithrombogenicity, heat resistance, and chemical resistance is used. Examples of the antithrombogenic material include polyurethane resin, polyamide resin, polyimide resin, polyvinyl chloride resin, fluororesin, and PET resin. Polyurethane resin-based polymer materials are particularly preferable, specifically thermoplastic. Polyether urethane and polyether polyurethane urea. The thickness of the balloon is about 50 μm to 200 μm.

  The balloon 2 is fixed to the distal end of the catheter shaft 3, and a liquid inlet 4 for expanding and contracting the balloon is provided at the rear end of the catheter shaft 3. The balloon 2 is placed at a predetermined position in the patient's body, liquid is introduced from the liquid inlet 4 and the balloon is expanded. As the liquid inside the balloon, a highly conductive substance is desirable. For example, a commercially available contrast agent is used in consideration of imaging with 0.2% by weight saline, physiological saline, or X-rays. Preferably, a diluted contrast agent in which a contrast agent and physiological saline are mixed at a ratio of 1: 1 is used. Inside the balloon 2, an in-balloon electrode 5A and an electrode 5B for supplying high-frequency power are disposed. The electrodes 5A and 5B are connected to the high-frequency generator 7 by electrode lead wires 5A1 and 5B1, respectively. The high frequency power for heating the balloon is generated by the high frequency generator 7 and supplied between the electrodes 5A and 5B to heat the liquid inside the balloon. The temperature inside the balloon is detected by the temperature sensor 8 inside the balloon, and the high frequency power is controlled so that the temperature is set in advance by the high frequency generator 7.

  FIG. 2 shows the configuration of a unipolar balloon catheter system according to this embodiment. 1 is different from the bipolar system of FIG. 1 in that the electrode 5 inside the balloon 2 is monopolar, and the counter electrode plate 6 for supplying high-frequency power to be paired is outside the balloon 2 and is on the patient's body surface. It is a point that is pasted on. The counter electrode plate 6 is connected to the high frequency generator 7 by a counter electrode plate lead wire 61. High frequency power for heating the balloon is generated by the high frequency generator 7 and is supplied between the electrode 5 and the counter electrode plate 6 to heat the liquid inside the balloon.

  The present invention is characterized in that both the bipolar system and the unipolar system have means for adjusting the time to reach the balloon surface temperature in accordance with the volume of the balloon. Here, FIG. 3 shows an ideal temperature rise curve of the balloon surface temperature in the ablation catheter with a balloon. When the time for the balloon surface temperature to reach the set temperature is short, for example, less than 30 seconds, the burden on the patient is not small. In addition, when the time for the balloon surface temperature to reach the specified temperature is long, for example, when it is 1 minute or longer, there is a possibility that the patient may be burdened by increasing the treatment time in a state where the pulmonary vein is occluded. That is, it is desirable to reach the set temperature in 30 seconds or more and less than 1 minute. However, when the temperature control method is not changed in accordance with the balloon internal volume, if the balloon internal volume is too small, the set temperature is reached in a time earlier than the ideal temperature rise curve as shown in FIG. On the other hand, when the balloon internal volume is too large, the set temperature is reached in a longer time than the ideal temperature rise curve as shown in FIG. In order to prevent these problems, the balloon catheter system according to the present invention is characterized in that the time required to reach the balloon surface temperature can be adjusted according to the internal volume of the balloon.

  Furthermore, the present invention is characterized in that the rate of increase in power supply is changed as means for adjusting the time required to reach the set balloon surface temperature.

When changing the rate of increase in power supply, as shown in FIG. 6, with reference to (1), when the balloon volume is small, the rate of increase in power supply is moderated as shown in (2). If it is larger, the time required to reach the set balloon surface temperature can be adjusted by abruptly increasing the power supply rate as shown in (3). Although FIG. 6 shows a relationship in which the power supply increases proportionally with time, there is no problem with a control method in which the power increases stepwise. That is, the present invention is characterized in that the average rate of increase in power supply is changed according to the balloon inner volume. Specifically, for example, when the balloon internal volume is 25000 mm ² to 250,000 mm ² and the average rate of increase in power supply is 5 W to 10 W per second, the time required to reach the set balloon surface temperature Can be adjusted to an optimum time.

Also, as shown in FIG. 7, the time to reach the set balloon surface temperature can be optimized by combining the means for changing the upper limit value of the power supply in addition to the means for changing the power supply increase rate. It is possible to adjust the time. That is, with reference to (1) that sets the power upper limit value of power supply, when the balloon internal volume is small, the rate of increase in power supply is moderated as in (2), while the balloon internal volume is large. In this case, the rate of increase in the power supply is suddenly increased as shown in (3), and the time required to reach the set balloon surface temperature can be adjusted.
As a method of giving a specific operation means of such adjusting means to the high frequency generator, the power supply increase ratio is set by arranging a button or a touch panel that can set and input the power supply increase ratio in the main body of the high frequency generator. The method of setting and inputting the parameter for the rate of increase in power supply inside the high-frequency generator using an external personal computer or parameter change dedicated device, and the rate of increase in power supply by entering the balloon volume and balloon diameter There are various methods such as a method using a program in which is automatically changed. That is, the present invention is not limited by the method of changing the rate of increase in power supply. Further, when the balloon internal volume during use is in the range of 25000 mm ² to 250,000 mm ² , and any known increase rate of the appropriate power supply is selected, any one point in the range of 5 W to 10 W per second The average rate of increase may be fixed. When the rate of increase in power supply is less than 5 W, when the balloon internal volume during use is in the range of 25000 mm ² to 250,000 mm ² , the time for the balloon surface temperature to reach the set temperature is shortened, and the patient The burden of is not small. Furthermore, if the high-frequency output increases instantaneously, the temperature of the liquid in the balloon rises before the temperature sensor in the balloon detects the temperature, and the liquid in the balloon may become higher than the set temperature. is there. On the other hand, when it exceeds 10 W, when the balloon internal volume during use is in the range of 25000 mm ² to 250,000 mm ² , it takes a long time for the balloon surface temperature to reach the set temperature, and the pulmonary vein is occluded. There is a possibility that the patient may be burdened due to long treatment time in the hospital.

  In addition, in the ablation catheter system with a rune of the present invention, if a malfunction occurs during the procedure and the specified balloon surface temperature is not reached within the set time, an abnormality is generated by an alarm or display. It is preferable to have a function of transmitting information to the operator or the operator. In this case, the operator or the operator can quickly take various measures against problems caused by abnormality.

Subsequently, more specific embodiments of the present invention will be described in the following examples of ablation catheters with balloons. As an example, an ablation catheter with a bipolar balloon was used.
[Production of catheter with balloon]
First, the balloon 2 was manufactured in three sizes.

  A balloon having a conical shape with a conical tip having a length from the balloon tip to the rear end of the balloon of 25 mm, a maximum outer diameter of 25 mm at the rear end, and a membrane thickness of 160 μm was manufactured as follows. That is, a glass balloon mold having a mold surface corresponding to a desired balloon shape is dipped in a polyurethane DMAC (dimethylacetamide) solution having a concentration of 13% by weight, and the solvent is evaporated by applying heat to the mold surface. A balloon was produced by a dipping method for forming a urethane polymer film (hereinafter abbreviated as a balloon having a diameter of 25 mm).

  Next, a balloon having a conical shape with a conical shape having a length from the balloon tip to the rear end of the balloon of 10 mm, a maximum outer diameter of 10 mm at the rear end, and a membrane thickness of 160 μm was manufactured in the same procedure (hereinafter referred to as diameter). (Abbreviated as 10 mm balloon).

  Finally, a balloon having a conical shape with a concavity having a length from the balloon tip to the balloon rear end of 50 mm, a maximum outer diameter of 50 mm at the rear end, and a membrane thickness of 160 μm was manufactured in the same procedure (hereinafter referred to as diameter). (Abbreviated as 50 mm balloon).

  Next, three catheter bodies excluding the balloon were produced.

  The outer tube shaft 3 of the catheter 1 is a polyvinyl chloride tube containing 12 Fr, an inner diameter of 2.7 mm, an overall length of 800 mm and containing 30% by weight of barium sulfate, and the outer surface of the sandblasted finish is 2.8 mm in diameter and 7 mm in length. The stainless steel pipe is inserted into the end of the tube as a metal pipe 8A, the four-way connector 9 is inserted into the rear end of the tube, and then the fitting portion is tied from the top with a nylon thread having a diameter of 0.1 mm. Fixed.

  On the other hand, a nylon 11 tube having a diameter of 4 Fr, an inner diameter of 1.1 mm, and an overall length of 900 mm is used as the inner cylindrical shaft 10. A stainless steel pipe having a diameter of 1.2 mm and a length of 6 mm and having a sandblasted outer surface is used as a metal pipe 8B. After the inner insertion, the fitting portion was bound and fixed from above the tube with a nylon thread having a diameter of 0.1 mm. Further, after a synthetic resin pipe 11 having an outer diameter of 2.0 mm, an inner diameter of 1.1 mm, and a length of about 10 mm is extrapolated and joined to the metal pipe 8B, the inner cylinder shaft 10 is connected to the outer cylinder via the four-way connector 9. After inserting into the shaft 3, the cap of the four-way connector 9 was tightened to manufacture the double-tube type catheter 1.

  Further, as the high-frequency energizing electrode 5A, the tip of a 0.5 mm diameter electric copper wire coated with silver plating with a thickness of 0.1 μm is shaped into a coil shape with an inner diameter of 1.6 mm and a length of 3 mm with solder. In addition to reinforcement, an electrically insulating protective coating was applied to other parts using tetrafluoroethylene-6fluoropropylene copolymer (FEP) to obtain a power supply lead 5A1. Further, as the other high-frequency energizing electrode 5B, the tip of a 0.5 mm diameter electric copper wire coated with silver plating with a thickness of 0.1 μm is shaped into a coil shape with an inner diameter of 1.6 mm and a length of 3 mm and soldered. In addition, an electrically insulating protective coating was applied to other portions using tetrafluoroethylene-6fluoropropylene copolymer (FEP) to obtain a power supply lead wire 5B1.

  Furthermore, as the temperature sensor 12, an ultrafine thermocouple double (copper-constantan) wire having an electrically insulating protective coating made of polytetrafluoroethylene was provided with a sensor lead wire 13.

  After the temperature sensor 12 is fixed to the high frequency energizing electrode 5A, the high frequency energizing electrodes 5A and 5B are inserted into the tip of the inner cylindrical shaft 10, and then the sensor lead wire 13 and the power supply lead wires 5A1 and 5B1 are connected. The clearance between the outer cylinder shaft 3 and the inner cylinder shaft 10 is pulled through, the sensor lead wire 13 and the rear ends of the power supply lead wires 5A1 and 5B1 are pulled out from the four-way connector 9, and the sensor lead wire 13 The portions near the tips of the metal pipes 8A of the power supply lead wires 5A1 and 5B1 were fixed to the metal pipe 8A with an aramid fiber fixture. At that time, the high-frequency energizing electrodes 5A and 5B were fixed so that the distance in the catheter axial direction was 3 mm (hereinafter abbreviated as the catheter body excluding the balloon).

  Finally, the produced balloons 3 of three sizes were fixed to the catheter body excluding the balloon as follows.

  First, the front end of a 25 mm diameter balloon is tied and fixed to a metal pipe 8B of the catheter body excluding the balloon with a 0.1 mm nylon thread, and the rear end of the balloon 2 is secured to the metal pipe 8A with a 0.1 mm nylon thread. The balloon-attached catheter was completed by binding and fixing (hereinafter abbreviated as a catheter with a balloon having a diameter of 25 mm).

  Next, the front end of a 10 mm diameter balloon is tied and fixed to the metal pipe 8B of the catheter body excluding the balloon with a 0.1 mm nylon thread, and the rear end of the balloon 2 is secured to the metal pipe 8A with a 0.1 mm nylon thread. The catheter with balloon was completed (hereinafter abbreviated as 10 mm diameter balloon catheter).

  Further, the front end portion of the balloon having a diameter of 50 mm is tied and fixed to the metal pipe 8B of the catheter body excluding the balloon with a 0.1 mm nylon thread, and the rear end portion of the balloon 2 is secured to the metal pipe 8A with the 0.1 mm nylon thread. The catheter with a balloon was completed by tying and fixing (hereinafter abbreviated as a catheter with a balloon having a diameter of 50 mm).

[Example 1]
[Ablation catheter system that can freely change the rate of increase in high-frequency power supply]
The ablation catheter was connected to the high frequency generator 7 by the sensor lead wire 13 and the power supply lead wires 5A1 and 5B1. The high frequency generator 7 has a function of inputting a set temperature and a function of detecting the temperature inside the balloon through the temperature sensor 12, and the high frequency power is supplied between the high frequency energization electrodes 5A and 5B so that the temperature inside the balloon becomes the set temperature. It is possible to supply power. The frequency of the high frequency generator 7 was set to 1.8 MHz, and the maximum output was set to 200 W. Further, the liquid inlet 4 of the ablation catheter was connected to a balloon liquid stirring device 14 for making the temperature of the liquid inside the balloon uniform. Furthermore, the high-frequency generator 7 has a function of inputting a value of an increase rate of the high-frequency power supply per second, and can freely change the increase rate of the high-frequency power supply. Moreover, the system which increases electric power supply proportionally with time is employ | adopted.

An ablation catheter system with a balloon was constructed by combining the ablation catheter described above and the high-frequency generator 7 (hereinafter abbreviated as the ablation catheter system of the example).
[Temperature increase experiment by ablation catheter system of Example]
First, a temperature increase experiment using a catheter with a balloon having a diameter of 25 mm was performed. A catheter with a balloon having a diameter of 25 mm was immersed in a water tank filled with 37 ° C. physiological saline, and the sensor lead wire 13 and the power supply lead wires 5A1 and 5B1 were connected to the high frequency generator 7. A catheter with a balloon with a diameter of 25 mm is injected with a diluted contrast medium in which a contrast medium (Ioxaglic acid injection solution: trade name Hexabrix 320) and physiological saline are mixed at a volume ratio of 1: 1, and the maximum outer diameter on the rear end side. Was expanded to 25 mm. The set temperature in the balloon 2 was set to 75 ° C., and high frequency power was supplied from the high frequency generator 7. The balloon surface temperature required to ablate the affected area is about 60 ° C., but in the case of a catheter with a balloon having a diameter of 25 mm, the balloon surface temperature becomes 60 ° C. when the set temperature in the balloon 2 is set to 75 ° C. The balloon surface temperature is uniform at any position on the balloon surface by the liquid agitating device 14 in the balloon. In the embodiment, the balloon surface temperature is measured by attaching a silicon-coated thermocouple above the maximum outer diameter portion on the balloon rear end side. The surface temperature was used. Furthermore, the value of the rate of increase in high-frequency power supply per second was set to 7W.

  As a result of the temperature rise experiment, the balloon surface temperature reached the designated temperature of 60 ° C. in about 45 seconds, and then kept at 60 ° C.

  Next, a temperature increase experiment using a catheter with a balloon having a diameter of 10 mm was performed. The maximum outer diameter on the rear end side of the balloon is expanded to 10 mm, the set temperature in the balloon 2 is set to 65 ° C., and the rate of increase in the high-frequency power supply per second is set to 3 W. Except that the high frequency power was supplied in step 7, the experiment and measurement were performed under the same conditions as the temperature increase experiment using a balloon catheter with a diameter of 25 mm. Here, the balloon surface temperature necessary to ablate the affected area is about 60 ° C. However, in the case of a catheter with a balloon having a diameter of 10 mm, when the set temperature in the balloon 2 is set to 65 ° C., the balloon surface temperature becomes 60 ° C. Become.

  As a result of the temperature rise experiment, the balloon surface temperature reached the designated temperature of 60 ° C. in about 45 seconds, and then kept at 60 ° C.

  Finally, a temperature increase experiment using a balloon catheter having a diameter of 50 mm was performed. The maximum outer diameter on the rear end side of the balloon is expanded to 50 mm, the set temperature in the balloon 2 is set to 85 ° C., and the rate of increase in the high frequency power supply per second is set to 12 W. Except that the high frequency power was supplied in step 7, the experiment and measurement were performed under the same conditions as the temperature increase experiment using a balloon catheter with a diameter of 25 mm. Here, the balloon surface temperature necessary to ablate the affected area is about 60 ° C. However, in the case of a catheter with a balloon having a diameter of 50 mm, the balloon surface temperature is set to 60 ° C. when the set temperature in the balloon 2 is set to 85 ° C. Become.

  As a result of the temperature rise experiment, the balloon surface temperature reached the designated temperature of 60 ° C. in about 45 seconds, and then kept at 60 ° C.

  In the ablation catheter system of the embodiment in which the increase rate of the high frequency power supply can be freely changed based on the result of the temperature increase experiment of the above embodiment, the balloon surface is adjusted by adjusting the increase rate of the high frequency power supply per second. It was possible to adjust the time for reaching the specified temperature to 30 seconds or more and less than 1 minute. That is, it is possible to provide a technique that places the least burden on the patient.

[Comparative Example 1]
As Comparative Example 1, a high frequency generator having no function of setting the rate of increase in high frequency power supply was manufactured (hereinafter, abbreviated as the high frequency generator of Comparative Example 1). That is, when the temperature in the balloon is lower than the set temperature, the high frequency power instantaneously reaches 200 W, which is the maximum output. By combining the high frequency generator of Comparative Example 1 and a catheter with a balloon having a diameter of 25 mm, a temperature rising experiment similar to the Example was performed as an ablation catheter system of Comparative Example 1.

  The experiment and measurement were performed under the same conditions as the temperature increase experiment using a catheter with a balloon having a diameter of 25 mm in Example 1 except that high-frequency power was supplied from the high-frequency generator of Comparative Example 1.

As a result of the temperature increase experiment, the balloon surface temperature reached the designated temperature of 60 ° C. in about 15 seconds.
The power supplied to the high-frequency generator of Comparative Example 1 instantaneously reaches 200 W, which is the maximum output immediately after the start of heating, gradually decreases after the balloon internal temperature reaches the set temperature, and the balloon internal temperature is 75 ° C. Changed to keep. As described above, since the maximum output is instantaneously reached immediately after the start of heating, the liquid temperature in the balloon rises before the temperature sensor in the balloon detects the temperature, and exceeds the set temperature. It was confirmed that the liquid boiled. Obviously, it is not preferable that the liquid inside the balloon becomes a temperature that greatly exceeds the set temperature and boils.

From the results of the temperature increase experiment of Comparative Example 1, it was found that a system that reaches the maximum output at least instantaneously is not preferable.
[Comparative Example 2]
As Comparative Example 2, a high-frequency generator having a high-frequency power supply increase rate fixed to 7 W per second was manufactured (hereinafter abbreviated as the high-frequency generator of Comparative Example 2). The ablation catheter system of the comparative example 2 is combined with the high frequency generator of the comparative example 2, a catheter with a balloon with a balloon having a diameter of 25 mm, a catheter with a balloon with a balloon with a diameter of 10 mm, and a catheter with a balloon with a balloon with a diameter of 50 mm. About, the temperature rising experiment similar to Example 1 was implemented.

  First, a temperature increase experiment using a catheter with a balloon having a diameter of 25 mm was performed. The experiment and measurement were performed under the same conditions as the temperature increase experiment using a catheter with a balloon having a diameter of 25 mm in Example 1 except that high-frequency power was supplied from the high-frequency generator of Comparative Example 2. The rate of increase in high-frequency power supply per second is fixed at 7W.

  As a result of the temperature rise experiment, the balloon surface temperature reached the designated temperature of 60 ° C. in about 45 seconds, and then kept at 60 ° C.

  Next, a temperature increase experiment using a catheter with a balloon having a diameter of 10 mm was performed. The experiment and measurement were performed under the same conditions as the temperature increase experiment using the catheter with a balloon having a diameter of 10 mm in Example 1 except that the high frequency power was supplied from the high frequency generator of Comparative Example 2. The rate of increase in high-frequency power supply per second is fixed at 7W.

As a result of the temperature rise experiment, the balloon surface temperature reached the designated temperature of 60 ° C. in about 20 seconds, and then kept at 60 ° C.
Finally, a temperature increase experiment using a balloon catheter having a diameter of 50 mm was performed. The experiment and measurement were performed under the same conditions as the temperature increase experiment using a catheter with a balloon having a diameter of 50 mm in Example 1 except that high-frequency power was supplied from the high-frequency generator of Comparative Example 2. The rate of increase in high-frequency power supply per second is fixed at 7W.

  As a result of the temperature increase experiment, the balloon surface temperature reached the designated temperature of 60 ° C. in about 70 seconds, and then kept at 60 ° C.

  From the results of the temperature increase experiment of Comparative Example 2, it was found that in the ablation catheter system of Comparative Example 2 in which the rate of increase in the high-frequency power supply cannot be changed, appropriate temperature control cannot be performed depending on the balloon volume. .

  In addition, this invention is not restricted to said Example, It is also possible to implement with the following forms.

  For example, the ablation catheter system of the embodiment is an example in which only the increase rate of the high-frequency power supply can be changed, but the adjustment is performed by changing the increase rate of the high-frequency power supply and setting the power upper limit value of the high-frequency power supply. Obviously, it is possible to obtain the same effect.

Furthermore, when the balloon internal volume is 25000 mm ² to 250,000 mm ² , the time required to reach the set balloon surface temperature is optimized by fixing the increase rate of the power supply to 5 W to 10 W per second. It can be a range.

It is a top view which shows the whole structure of the ablation catheter system of one Embodiment of this invention. It is a top view which shows the whole structure of the ablation catheter system of one Embodiment of this invention. It is a figure which shows the ideal temperature rising curve of balloon surface temperature. It is a temperature rising curve of the balloon surface temperature, and shows a state in which the set temperature is reached in a time earlier than the ideal temperature rising curve. It is a temperature increase curve of the balloon surface temperature, and shows a state in which the set temperature is reached in a longer time than the ideal temperature increase curve. It is a figure which shows a mode that the raise rate of the high frequency electric power supply of one Embodiment of this invention is changed. It is a figure which shows combining the means to change the raise rate of the high frequency electric power supply of one Embodiment of this invention, and the means to set an electric power upper limit. It is a top view which shows the ablation catheter system of an Example of this invention. It is a top view which shows the balloon part detail of the ablation catheter system of this invention Example. It is an Example top view of the conventional ablation catheter which uses the counter electrode arrange | positioned outside a patient body.

Explanation of symbols

1: catheter with balloon 2: balloon 3: outer cylinder shaft 4: liquid introduction port 5A, 5B: high frequency energizing electrode in the balloon 5A1, 5B1: lead wire for power supply 6: counter electrode plate 61: counter electrode lead wire 7: High-frequency generator 8: Balloon temperature sensor 9: Four-way connector 10: Inner cylinder shaft 11: Plastic pipe 12: Temperature sensor 13: Sensor lead wire 14: Balloon liquid agitator

Claims (3)

A catheter shaft having a liquid supply channel,
Attached to the catheter shaft, a balloon in communication with the liquid supply path,
An in-balloon electrode and an in-balloon temperature sensor attached to the inside of the balloon ;
It means that to supply power before Symbol balloon electrode,
Have a, and means capable of setting a rise value per unit of the power time,
The internal volume of the balloon is 25000-250,000 mm ³ ,
The ablation catheter system with a balloon , wherein an increase value of the electric power per unit time is 5 to 10 W per second . To have a means for changing the upper limit value of the power, with a balloon ablation catheter system according to claim 1. Has an alarm function, balloon ablation catheter system according to claim 1 or 2.

Images