JP2002301087A - Balloon catheter for multipurpose ablation - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon catheter for multipurpose ablation capable of three-dimensionally forming a transmural necrotic layer. SOLUTION: This balloon catheter comprises a catheter shaft formed of mutually slidable catheter outer cylinder shaft 2 and catheter inner cylinder shaft 6; a contractible and expansible balloon 4 set between the tip of the catheter outer cylinder shaft contactable with a target lesion part in an expanded state and the vicinity of the tip part of the catheter inner cylinder shaft; at least one drawing cable 10 inserted to the catheter outer cylinder shaft with the tip fixed to the vicinity of the tip of the catheter inner cylinder shaft within the balloon and capable of bending the catheter inner cylinder shaft by being drawn; a high frequency current-carrying electrode 8 arranged on the inner wall of the balloon or within the balloon and capable of transmitting a high frequency power with a counter electrode arranged on the body surface; a lead wire 12 electrically connected to the high frequency current-carrying electrode; and a temperature sensor 14 capable of monitoring the internal temperature of the balloon.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a balloon catheter for multipurpose ablation, and more particularly, to treating a cardiac arrhythmia by changing the shape of the balloon, bringing the balloon into close contact with a target lesion, and performing high-frequency heating. The present invention relates to a balloon catheter for multipurpose ablation for locally treating a patient.

[0002]

2. Description of the Related Art There is known a method of causing a arrhythmia source to be electrocoagulated by bringing a metal electrode catheter made of a 4 mm-sized tip into contact with the arrhythmia source and applying high-frequency current. However, this approach is
It is good when the source is local such as W syndrome or paroxysmal supraventricular tachycardia, but the source is such as atrial fibrillation, atrial flutter, ventricular tachycardia associated with organic heart disease, etc. Is not very effective when is extensive.

On the other hand, a method of electrically isolating a pulmonary vein by high-frequency heating using a deflated balloon is known (Japanese Patent No. 2574119 by the present applicant).

[0004]

In order to treat atrial flutter and fibrillation, it is necessary to form a block line by performing linear ablation in the atrium. However, the conventional method requires 10 or more energizations, and it is technically difficult to perform continuous cauterization.

In order to ablate a ventricular arrhythmia having a wide range of sources deep in the myocardium, it is necessary to use an electrode having a large diameter and to use an ablation system having a cooling function. However, the diameter of the peripheral blood vessel is limited, and it is difficult to insert an electrode having a diameter of 5 mm or more. In addition, when a system with a cooling function is used, there is a risk that a cardiac explosion may occur due to a steam explosion in the deep part of the myocardium, and it is difficult to cure ventricular tachycardia associated with myocardial infarction.

When a current is applied a plurality of times using a metal electrode,
There was a risk of thrombus forming on the rough metal surface and causing embolism.

Therefore, an object of the present invention is to solve the above-mentioned problems of the prior art, and to eliminate the risk of thrombus formation and heart rupture.
Provided is a multipurpose ablation balloon catheter capable of forming a transmural necrotic layer three-dimensionally and performing ablation treatment of atrial flutter, fibrillation and ventricular tachycardia associated with organic heart disease. It is to be.

[0008]

In order to achieve the above object, a multipurpose ablation balloon catheter according to the present invention comprises a catheter shaft comprising a catheter outer tube shaft and a catheter inner tube shaft which are slidable with each other, and an inflated state. A deflated and inflatable balloon installed between the distal end of the catheter outer cylindrical shaft having a shape capable of contacting the target lesion and the distal end of the catheter inner cylindrical shaft, and inside the catheter outer cylindrical shaft. At least one indexing cable that is inserted and has a distal end fixed to the vicinity of the distal end of the catheter inner cylindrical shaft in the balloon and is indexed so that the catheter inner cylindrical shaft can be bent; Between the pressure adjusting means for adjusting the degree of A high frequency current applying electrode disposed in the wall or balloon of the balloon capable of transmitting power, and a lead wire electrically connected to the high frequency current-carrying electrodes,
A temperature sensor capable of monitoring the temperature inside the balloon.

In the above invention, the diameter of the balloon is changed by adjusting the degree of deflation and inflation, and the length of the balloon is changed by adjusting the distance between the catheter outer tube shaft and the catheter inner tube shaft that can slide with each other. In addition, the shape of the balloon can be changed by bending the catheter inner cylinder shaft using the indexing cable, and the balloon can assume various three-dimensional shapes. For example, the tricuspid valve and the inferior vena cava can be used. The balloon can be brought into close contact with target lesions having various three-dimensional shapes, such as between the gorge, the septum and the pulmonary veins.
As described above, the shape of the balloon can be adjusted according to the type of the target lesion, and the target lesion can be ignited (ablated) for various purposes.

Further, the balloon is made of an antithrombotic resin.

Further, the high-frequency electrode is wound around the outer periphery of the catheter inner cylinder shaft in the balloon.

Further, the high-frequency power supply electrode is supplied with high-frequency power so that the temperature of the balloon becomes a predetermined temperature while monitoring the temperature sensor.

The high-frequency power supply electrode is supplied with high-frequency power such that the impedance between the high-frequency electrode and the counter electrode is within a predetermined range while monitoring the impedance.

Further, the inside of the catheter barrel and the balloon are made of an antithrombotic resin having a smooth surface.

[0015] Further, there is provided a cooling water perfusion means for perfusing cooling water for suppressing overheating caused by the high-frequency energizing electrode into the catheter inner cylinder shaft. Thus, overheating of the high-frequency power supply electrode can be avoided, and large power can be supplied to the high-frequency power supply electrode.

[0016]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of a balloon catheter for pulmonary vein multipurpose ablation according to the present invention will be described below with reference to the accompanying drawings.

First, a first embodiment will be described with reference to FIG. As shown in FIG. 1, a balloon catheter 1 includes a catheter shaft composed of a catheter outer tube shaft 2 and a catheter inner tube shaft 6 slidable with each other, and a balloon catheter having a shape capable of contacting a target lesion in an expanded state. A deflated and expandable balloon 4 installed between the distal end of the outer cylindrical shaft 2 and the vicinity of the distal end of the catheter inner cylindrical shaft 6, an electrode 8 for high-frequency power supply disposed in the balloon 4, and an electrode for high-frequency power supply A lead wire 12 that is electrically connected to the catheter inner tube 8 and a distal end portion that is inserted into the catheter outer cylindrical shaft 2 and is fixed to the vicinity of the distal end portion of the catheter inner cylindrical shaft 6 in the balloon 4 and is indexed. At least one, for example, two indexing cables 10 disposed at opposing positions capable of bending the shaft 6, And a thermocouple 14 disposed in the balloon 4 to monitor the degree.

The index cable 10 is connected to index control means 50. By individually adjusting the degree of attraction of each index cable 10 by the index control means 50, the catheter inner cylinder shaft 6 can be bent in a desired direction, and the shape of the balloon 4 can be adjusted. . In addition, by individually adjusting the degree of attraction of each index cable 10, the attitude of the balloon 4 with respect to the target lesion to be ablated can be variously adjusted.

The catheter outer tube shaft 2 and the catheter inner tube shaft 6 are slid in the longitudinal direction by the adjusting means 52 along the catheter outer tube shaft 2 and the catheter inner tube shaft 6. The catheter outer cylinder shaft 2 and the catheter inner cylinder shaft 6 are adjusted by the adjusting means 52.
Are slid together, the length of the balloon 4 can be adjusted. The index cable 10
However, the number is not limited to two as long as it is one or more.

The adjusting means 52 can adjust not only the sliding of the catheter outer tube shaft 2 and the catheter inner tube shaft 6 in the longitudinal direction, but also the degree of contraction and inflation of the balloon 4. By adjusting the degree of deflation and inflation of the balloon 4 by the adjusting means 52, the balloon 4
Can be changed.

As described above, by adjusting the shape, posture, length and diameter of the balloon 4 by the index control means 50 and the adjusting means 52, various types of balloon 4 can be applied to the target lesion to be ablated. It is possible to take a three-dimensional shape.

FIG. 1 shows a linear balloon 4 that is effective when the target lesion to be ablated is the isthmus between the tricuspid valve and the inferior vena cava, the atrial septum, and the atrial free wall. FIG. 2 shows a spherical balloon 4 effective when the target lesion to be ablated is a ventricular muscle.

The balloon 4 is made of an antithrombotic and heat-resistant resin having a smooth surface. The catheter outer tube shaft 2 and the catheter inner tube shaft 6 are
It is formed of an antithrombotic and heat-resistant resin having a smooth surface as in the above.

A high-frequency electrode 8 is wound in a coil shape around the outer periphery of the inner catheter shaft 6 in the balloon 4. A guide wire 32 is inserted into the catheter inner tube shaft 6. In addition, a cooling liquid composed of physiological saline may be injected into the catheter inner cylinder shaft 6 from above, and the catheter inner cylinder shaft 6 heated by the high-frequency electrode 8 may be cooled by the cooling liquid. In this case, the cooling water is supplied to the catheter inner cylinder shaft 6.
Is excreted from the lower part of the body. Thus, overheating of the high-frequency electrode 8 can be avoided, and a large amount of power can be supplied to the high-frequency electrode 8. The cooling water perfusion means for perfusing the cooling water for suppressing the overheating caused by the high-frequency power supply electrode 8 into the catheter inner cylindrical shaft 6 includes a pipe and a pump for perfusing a saline solution as the cooling water. I have.

As shown in FIG. 1, the lead wire 12 connected to the high-frequency power supply electrode 8 is
And a high-frequency generator 40 that can supply high-frequency power of 13.56 MHz, for example, and passes between the inside of the inside of the inner tube and the outside of the catheter inner cylinder shaft 6. In addition, a return electrode 44 installed at the surface of the patient's body, for example, at the back, is connected to the high-frequency generator 40 via the lead wire 42. High-frequency power is supplied between the high-frequency power supply electrode 8 and the counter electrode plate 44 by the high-frequency generator 40. For example, when the diameter of the balloon 4 is about 2.5 cm, 100 W to 20 W
A high-frequency power of 0 W is supplied.

The high-frequency current is applied to the current-carrying electrode 8 of the catheter 1.
The temperature is monitored by the temperature sensor 14 installed on the balloon 4 or the catheter inner tube shaft 6 between the body and the counter electrode plate 44 on the body surface. The tissue in contact with balloon 4 is cauterized by capacitive heating with high frequency dielectric heat. As a result, in addition to Joule heat, a portion (balloon wall) where dielectrics having different dielectric constants contact each other in accordance with the principle of so-called high-frequency induction heating is heated, and FIG.
As shown in (2), the tissue at the joint 26 that contacts the balloon 4 is heated and cauterized.

The temperature inside the balloon 4 is monitored by a thermocouple 14 via a thermometer 41, and the high-frequency power supplied by the high-frequency generator 40 is adjusted so that the temperature inside the balloon 4 becomes 60 ° C. to 70 ° C. It is adjusted via a feedback circuit. Thereby, the temperature of the joint portion 26 is maintained at the optimal temperature of 60 ° C. to 70 ° C., and the carbonization of tissue and the formation of thrombus can be prevented.

The high-frequency generator 40 has a function of monitoring the impedance between the high-frequency power supply electrode 8 and the counter electrode plate 44. The application time of the high-frequency power is controlled so as to be within a predetermined range. Thereby, the joint 2
6 can be controlled. The high-frequency generator 40 is provided with a safety device so that the supply of high-frequency power is instantaneously stopped when the impedance rises sharply.

As described above, by adjusting the internal pressure of the balloon 4, the distance between the distal end between the catheter outer cylindrical shaft 2 and the catheter inner cylindrical shaft 6, and the degree of bending of the catheter inner cylindrical shaft 6, the three-dimensional shape of the balloon 4 is improved. By changing the shape of the balloon 4 and the attitude angle of the balloon 4 with respect to the catheter inner cylinder shaft 6, it becomes easy to bring the balloon 4 into close contact with the target lesion.

Next, a specific example applied to a target lesion to be ablated will be described with reference to FIGS.

First, a first embodiment will be described with reference to FIGS. This embodiment relates to atrial flutter and fibrillation. In order to cure atrial flutter and fibrillation, it is necessary to form a linear transmural coagulative necrotic layer in the atrium without thrombosis.

FIG. 3 shows an example of linear ablation of the tricuspid valve-vena valvular region for atrial flutter using the balloon 4 shown in FIG. 1, and FIG. 4 is a three-dimensional schematic diagram thereof.

As shown in FIG. 3, the balloon catheter 1
Is the outer cylinder shaft 2, the inner cylinder shaft 6 and the heat-resistant diameter of about 1
The catheter 1 includes a balloon 4 having a length of 3 cm and a length of 3 cm, a temperature sensor 14, and a cable 10 for drawing. The catheter 1 is inserted through a femoral vein. When the balloon catheter 1 enters the right atrium through the inferior vena cava, the balloon 4 is expanded, the index cable 10 is pulled, the Naito shaft 6 is bent, and the entire lower surface of the balloon 4 is trimmed while the balloon catheter 1 is pulled back. It is applied to the cusp and between the great veins. When the contact is insufficient, the index cable 10 is further pulled, or the inner cylinder shaft 6 is slightly pulled to shorten the length of the balloon 4 and pressurize the balloon 4 to further inflate the joint, which is a tissue to be ablated. Increase the degree of adhesion with 26. When the high-frequency current is applied while monitoring the temperature sensor 14 between the electrode 8 in the balloon 4 and the counter electrode plate 44 using, for example, 13.56 MHz, the temperature of the balloon-tissue contact surface is obtained by capacitive heating with high-frequency dielectric heating. Rises. When this is heated to 60 ° C. to 70 ° C. and energized for about 2 minutes, the canal is cauterized linearly and transcutaneously by a current of 1-3 times to form a block line, and atrial flutter is cured. In a similar way to cure atrial fibrillation,
Block lines may be created between the atrial septum, around the pulmonary vein ostium, and between the pulmonary vein and the mitral annulus.

Next, a second embodiment will be described with reference to FIG. The present embodiment relates to ventricular tachycardia. Ventricular tachycardia associated with organic heart disease often has a wide range of complex arrhythmic sources deep in the myocardium. To eradicate this, three-dimensionally, ventricular muscle with a thickness of 1 cm or more must be transmural. It is necessary to cauterize without complications. In contrast, the prior art cannot cope with this.

In this embodiment, in order to solve this problem, a spherical high-frequency hot balloon having a diameter of 1 cm to 2 cm as shown in FIG. 2 is used. As shown in FIG. 5, the balloon 4 is attached so that the distal end portion of the inner cylindrical shaft 6 does not protrude from the balloon 4 in the expanded state. This is because if the inner cylinder shaft 6 is protruding, contact between the balloon 4 and the tissue is hindered.

First, the balloon catheter 1 is inserted into the ventricle by the guide wire 32 to expand the balloon 4. Thereafter, the guide wire 32 is replaced with a small-diameter electrode catheter (not shown), and the electrode tip of the electrode catheter is put out of the balloon 4 by 2 mm to 3 mm to record an intraventricular potential. Here, the electrode catheter is a diagnostic catheter for recording intracardiac potential.

Next, based on the result recorded using the electrode tip of the electrode catheter, the inside of the ventricle is mapped while the inner cylinder shaft 6 is bent by the index cable 10 to search for the source of ventricular tachycardia. Next, the electrode catheter is removed, and the balloon 4 is pressed against the target tissue. When the degree of adhesion is low, the inner pressure of the balloon 4, the length of the balloon, and the degree of traction of the index cable 10 are changed. The high-frequency current is applied for 2 minutes while maintaining the contact surface temperature of the balloon tissue at 60 to 70 ° C. According to the experimental data according to this example, if the contact area is set to 1 cm 2 or more, the heat penetration can easily exceed 1 cm, and a transmural necrotic layer can be formed in the ventricular muscle.
Ventricular tachycardia can be cured.

As described above, it has become possible to cure atrial flutter, atrial fibrillation, and ventricular tachycardia associated with organic heart disease, which have been considered intractable, and now 2 million people can be cured. It will be possible to provide a gospel treatment for patients who survive.

[0039]

As described above, according to the structure of the present invention, since the shape and posture of the balloon can be changed according to the type of the target lesion, the adhesion between the target lesion and the balloon can be improved. Burning by high-frequency heating can be performed. As a result, a transmural necrotic layer can be formed three-dimensionally without danger of thrombus formation or cardiac rupture, and ablation treatment for atrial flutter, fibrillation, and ventricular tachycardia associated with organic heart disease. A balloon catheter can be provided.

[Brief description of the drawings]

FIG. 1 is a diagram showing a schematic configuration of a balloon catheter for multipurpose ablation of the present invention.

FIG. 2 is a diagram showing an example in which the shape of a balloon is spherical.

FIG. 3 is a diagram showing the tricuspid valve and the intervenous isthmus for atrial flutter.
The figure which shows the example which performs linear ablation using the balloon shown in FIG.

FIG. 4 is a schematic three-dimensional view showing the example shown in FIG. 3;

FIG. 5 is a diagram showing an example in which ventricular muscle is cauterized transmurally without complications using the balloon shown in FIG. 2;

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Balloon catheter 2 Catheter outer cylinder shaft 4 Balloon 4 6 Catheter inner cylinder shaft 8 Electrode for high frequency electricity 10 Index cable 12 Lead wire 14 Temperature sensor 40 High frequency generator

 ──────────────────────────────────────────────────続 き Continued on the front page F term (reference) 4C053 CC03 4C060 KK03 KK04 KK10 KK16 KK25 KK47 MM25 4C167 AA06 BB62 CC08 CC09 CC30 DD10

Claims (7)

[Claims] 1. A catheter shaft comprising a catheter outer tube shaft and a catheter inner tube shaft slidable with each other, a distal end portion of the catheter outer tube shaft having a shape capable of contacting a target lesion in an expanded state, and the catheter. A deflated and expandable balloon installed between the vicinity of the distal end of the inner cylinder shaft, and the distal end is inserted into the catheter outer cylinder shaft, and the distal end is fixed to the vicinity of the distal end of the catheter inner cylinder shaft in the balloon, At least one indexing cable capable of bending the catheter inner cylinder shaft by being indexed, and in a balloon wall or in a balloon capable of transmitting high-frequency power between a counter electrode disposed on the body surface. An electrode for high-frequency power supply provided, a lead wire electrically connected to the electrode for high-frequency power supply, and the balloon Balloon catheter versatile ablation, characterized in that it comprises a monitor capable of a temperature sensor the temperature of the. 2. The multipurpose ablation balloon catheter according to claim 1, wherein the balloon is made of an antithrombotic resin. 3. The multi-purpose ablation balloon catheter according to claim 1, wherein the high-frequency electrode is wound around the outer circumference of the catheter inner cylindrical shaft in the balloon. 4. The multipurpose power supply according to claim 1, wherein high-frequency power is supplied to the high-frequency power supply electrode so that the temperature of the balloon becomes a predetermined temperature while monitoring the temperature sensor. Ablation balloon catheter. 5. The high-frequency power supply electrode is supplied with high-frequency power so that the impedance between the high-frequency electrode and the counter electrode is monitored so that the impedance falls within a predetermined range. 4. The balloon catheter for multipurpose ablation according to 4. 6. The multi-purpose ablation balloon catheter according to claim 1, wherein the inside of the catheter sleeve and the balloon are formed of an antithrombotic resin having a smooth surface. 7. A balloon for multipurpose ablation according to claim 1, further comprising a cooling water perfusion means for perfusing cooling water for suppressing overheating caused by said high-frequency current supplying electrode into said catheter inner cylinder shaft. catheter.