JP3611799B2 - Multipurpose ablation balloon catheter - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a multipurpose ablation balloon catheter, and more particularly, to multipathically treat a lesion by changing the shape of the balloon to closely adhere to the target lesion and performing high-frequency heating to treat cardiac arrhythmia. The present invention relates to an ablation balloon catheter.
[0002]
[Prior art]
A technique is known in which an arrhythmia source is 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 technique is good when the source is local, such as WPW syndrome or paroxysmal supraventricular tachycardia, but ventricular tachycardia associated with atrial fibrillation, atrial flutter, organic heart disease, etc. It is not very effective when the source is wide, such as.
[0003]
On the other hand, a technique of electrically isolating pulmonary veins by high-frequency heating using a retractable balloon is known (Japanese Patent No. 2574119 by the present applicant).
[0004]
[Problems to be solved by the invention]
In order to treat atrial flutter and fibrillation, it is necessary to form a block line by linearly cauterizing the inside of the atrium. However, the conventional method requires energization 10 times or more, and it has been technically difficult to perform continuous cauterization.
[0005]
In addition, in order to ablate ventricular arrhythmia having a source in a wide range in the deep part of the myocardium, an electrode having a large diameter is required and an ablation system with a cooling function must be used. 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 water vapor explosion occurs in the deep part of the myocardium and a cardiac rupture is involved, and it is difficult to completely cure ventricular tachycardia associated with myocardial infarction.
[0006]
Further, when a current was applied multiple times using a metal electrode, a thrombus was formed on the rough metal surface, and there was a risk of embolism.
[0007]
Accordingly, an object of the present invention is to eliminate the above-mentioned problems of the prior art, and to form a transmural necrosis layer three-dimensionally without risk of thrombus formation or cardiac rupture. To provide a multipurpose ablation balloon catheter capable of ablation treatment for ventricular tachycardia associated with fibrillation and organic heart disease.
[0008]
[Means for Solving the Problems]
To achieve the above object, the multipurpose ablation balloon catheter of the present invention has a catheter shaft composed of a catheter outer tube shaft and a catheter inner tube shaft that are slidable with each other, and a shape that can contact a target lesion in an expanded state. A balloon that can be contracted and inflated installed between the distal end portion of the catheter outer tube shaft and the vicinity of the distal end portion of the catheter inner tube shaft, and the distal end portion that is inserted into the catheter outer tube shaft. At least one indexing cable that can be bent and indexed by being fixed and indexed in the vicinity of the distal end portion of the inner tube shaft, and pressure adjusting means for adjusting the degree of contraction and expansion of the balloon; The balloon capable of transmitting high-frequency power between the counter electrode disposed on the body surface A high-frequency energizing electrode disposed in the wall or the balloon, a lead wire electrically connected to the high-frequency energizing electrode, and a temperature sensor capable of monitoring the temperature in the balloon. Features.
[0009]
In the above-described invention, the balloon diameter is changed by adjusting the degree of contraction and expansion, 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, and It is possible to change the shape of the balloon by bending the inner tube shaft of the catheter using the index cable, and to make the balloon take various three-dimensional shapes, for example, the canyon between the tricuspid valve and the inferior vena cava In addition, the balloon can be brought into close contact with the target lesion having various three-dimensional shapes such as between the septum and the pulmonary vein. Thus, the shape of the balloon can be adapted according to the type of the target lesion, and various target lesions can be heated (ablated) for various purposes.
[0010]
The balloon is made of an antithrombotic resin.
[0011]
Further, the high-frequency energizing electrode is wound around the outer periphery of the catheter inner tube in the balloon.
[0012]
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.
[0013]
The high-frequency power supply electrode is supplied with high-frequency power so that the impedance between the counter electrode and the counter electrode is monitored within a predetermined range.
[0014]
Further, the inside of the catheter outer shaft and the balloon are formed of an antithrombotic resin having a smooth surface.
[0015]
Moreover, it is provided with the cooling water perfusion means which perfuses the cooling water which suppresses the overheating resulting from the said electrode for high frequency electricity supply in the said catheter internal cylinder shaft. As a result, overheating of the high-frequency energization electrode can be avoided, and high power can be supplied to the high-frequency energization electrode.
[0016]
DETAILED DESCRIPTION OF THE INVENTION
Embodiments of a balloon catheter for pulmonary vein multipurpose ablation according to the present invention will be described below with reference to the accompanying drawings.
[0017]
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 contractible and inflatable balloon 4 disposed between the distal end portion of the outer tube shaft 2 and the vicinity of the distal end portion of the catheter inner tube shaft 6, a high-frequency energization electrode 8 disposed in the balloon 4, and a high-frequency energization electrode The lead wire 12 electrically connected to the catheter 8 and the catheter inner tube 2 are inserted into the catheter outer tube shaft 2 and the distal end portion is fixed and indexed near the distal end portion of the catheter inner tube shaft 6 in the balloon 4. At least one indexable cable 10 that can bend the shaft 6, for example, two index cables 10 disposed at opposing positions, And a thermocouple 14 disposed in the balloon 4 to monitor the degree.
[0018]
The index cable 10 is connected to the index control means 50. By individually adjusting the degree of attraction of each index cable 10 by the index control means 50, the inner tube 6 of the catheter can be bent in a desired direction, and the shape of the balloon 4 can be adjusted. . Further, by individually adjusting the degree of attraction of each index cable 10, the posture of the balloon 4 with respect to the target lesion part to be ablated can be variously adjusted.
[0019]
Further, the catheter outer tube shaft 2 and the catheter inner tube shaft 6 are slid relative to each other in the longitudinal direction by the adjusting means 52. The length of the balloon 4 can be adjusted by sliding the catheter outer tube shaft 2 and the catheter inner tube shaft 6 with each other by the adjusting means 52. In addition, although the example which provided two as the cable 10 for indexes was shown, if it is one or more, it will not be restricted to two.
[0020]
Further, the adjusting means 52 can adjust not only the longitudinal slide adjustment of the catheter outer tube shaft 2 and the catheter inner tube shaft 6 but also the degree of contraction and expansion of the balloon 4. The diameter of the balloon 4 can be changed by adjusting the degree of contraction and expansion of the balloon 4 by the adjusting means 52.
[0021]
In this way, by adjusting the shape, posture, length, and diameter of the balloon 4 by the index control means 50 and the adjusting means 52, various three-dimensional shapes can be applied to the balloon 4 with respect to the target lesion part to be ablated. It becomes possible to take the shape.
[0022]
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, or the atrial free wall. FIG. 2 shows a spherical balloon 4 that is effective when the target lesion to be ablated is a ventricular muscle.
[0023]
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 formed of an antithrombotic and heat resistant resin having a smooth surface like the balloon 4.
[0024]
A high-frequency energizing electrode 8 is wound around the outer periphery of the catheter inner tube 6 in the balloon 4 in a coil shape. A guide wire 32 is inserted into the inner tube shaft 6 of the catheter. In addition, a cooling liquid made of physiological saline may be injected into the catheter inner cylindrical shaft 6 from above, and the catheter inner cylindrical shaft 6 heated by the high-frequency energizing electrode 8 may be cooled by the cooling liquid. In this case, the cooling water is discharged from the lower part of the catheter inner tube 6 into the body. As a result, overheating of the high-frequency energization electrode 8 can be avoided, and high power can be supplied to the high-frequency energization electrode 8. The cooling water perfusion means for perfusing cooling water that suppresses overheating caused by the high-frequency energizing electrode 8 into the catheter inner tube 6 is composed of a pipe and a pump for perfusing saline as cooling water. Yes.
[0025]
As shown in FIG. 1, the lead wire 12 connected to the high-frequency energizing electrode 8 passes between the inside of the catheter outer tube shaft 2 and the outside of the catheter inner tube shaft 6, for example, high frequency power of 13.56 MHz. It is connected to a high frequency generator 40 that can be supplied. In addition, a counter electrode 44 installed on the patient's body surface, for example, the position of the back, is connected to the high-frequency generator 40 via a lead wire 42. The high frequency generator 40 supplies high frequency power between the high frequency energization electrode 8 and the counter electrode plate 44. For example, when the diameter of the balloon 4 is about 2.5 cm, high frequency power of 100 W to 200 W is supplied.
[0026]
The high-frequency energization is performed while monitoring the temperature between the energizing electrode 8 of the catheter 1 and the counter electrode plate 44 on the body surface by the temperature sensor 14 installed on the balloon 4 or the catheter inner tube 6. The tissue in contact with the balloon 4 is cauterized by capacitive heating with high frequency dielectric heat. As a result, in accordance with the principle of so-called high-frequency induction heating in addition to Joule heat, a portion (balloon wall) where a dielectric having a different dielectric constant comes into contact is heated, and as shown in FIG. The tissue is heated and cauterized.
[0027]
The temperature in the balloon 4 is monitored by the thermocouple 14 via the thermometer 41, and the high-frequency power supplied by the high-frequency generator 40 controls the feedback circuit so that the temperature in the balloon 4 is 60 ° C to 70 ° C. Adjusted through. As a result, the temperature of the joint portion 26 is maintained at the optimum 60 ° C. to 70 ° C., and carbonization of the tissue and thrombus formation can be prevented.
[0028]
The high-frequency generator 40 has a function of monitoring the impedance between the high-frequency energizing electrode 8 and the counter electrode plate 44, and the impedance value between the high-frequency energizing electrode 8 and the counter electrode plate 44 falls within a predetermined range. As is the case, the application time of the high frequency power is controlled. Thereby, it is possible to control the range of the area where the joint 26 is heated. The high frequency generator 40 is equipped with a safety device so that the supply of high frequency power stops instantaneously when the impedance rises rapidly.
[0029]
In this way, the three-dimensional shape of the balloon 4 is adjusted by adjusting the internal pressure of the balloon 4, the distance between the tips of the catheter outer tube shaft 2 and the catheter inner tube shaft 6, and the degree of bending of the catheter inner tube shaft 6. The posture angle of the balloon 4 with respect to the inner tube shaft 6 of the catheter is changed, and the balloon 4 can be easily brought into close contact with the target lesion.
[0030]
Next, a specific example applied to the target lesion site to be ablated will be described with reference to FIGS.
[0031]
First, the first embodiment will be described with reference to FIGS. This example relates to atrial flutter and fibrillation.
In order to cure atrial flutter and fibrillation, it is necessary to form a linear transmural coagulative necrosis layer in the atrium without thrombosis.
[0032]
FIG. 3 shows an example of linear ablation of the tricuspid valve / large vena cava portion for atrial flutter using the balloon 4 shown in FIG. 1, and FIG. 4 is a three-dimensional schematic diagram thereof.
[0033]
As shown in FIG. 3, the balloon catheter 1 includes an outer tube shaft 2 and an inner tube shaft 6, a heat resistant diameter of about 1 cm, a balloon 4 having a length of 3 cm, a temperature sensor 14, and a traction cable 10. 1 is inserted from the 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, the balloon catheter 1 is pulled back, and the entire lower surface of the balloon 4 is moved. The cuspid valve is applied to the great vein. 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 it. Increase the degree of adhesion with 26. For example, when high-frequency energization is performed while monitoring with the temperature sensor 14 between the electrode 8 in the balloon 4 and the counter electrode plate 44 using 13.56 MHz, the temperature of the balloon-tissue contact surface is caused by capacitive heating with high-frequency dielectric heating. Rises. When this is energized at 60 ° C. to 70 ° C. for about 2 minutes, the isthmus is cauterized into a transmural shape linearly by energizing 1-3 times to form a block line, and atrial flutter is completely cured. In order to cure atrial fibrillation, a block line may be created between the atrial septum, the pulmonary vein ostium, and the pulmonary vein ro-mitral valve annulus in a similar manner.
[0034]
Next, a second embodiment will be described with reference to FIG. This example relates to ventricular tachycardia.
In many cases, ventricular tachycardia associated with organic heart disease has a complex arrhythmia source in the deep part of the myocardium. To cure this, ventricular muscles with a thickness of 1 cm or more in three dimensions are transmural. It is necessary to cauterize without complications. This is not possible with the prior art.
[0035]
In this embodiment, in order to solve this, a spherical high frequency hot balloon having a diameter of 1 to 2 cm as shown in FIG. 2 is used. As shown in FIG. 5, the balloon 4 is attached so that the tip of the inner cylindrical shaft 6 does not protrude beyond the balloon 4 in the expanded state. This is because if the inner cylindrical shaft 6 protrudes, the contact between the balloon 4 and the tissue is hindered.
[0036]
First, the balloon catheter 1 is inserted into the ventricle by the guide wire 32 and the balloon 4 is expanded. Thereafter, the guide wire 32 is replaced with a small-diameter electrode catheter (not shown), and the tip of the electrode catheter is placed 2 mm to 3 mm outside the balloon 4 to record the intraventricular potential. Here, the electrode catheter is a diagnostic catheter for recording an intracardiac potential.
[0037]
Next, based on the result recorded using the electrode tip of the electrode catheter, the ventricle tachycardia is searched by mapping the ventricle while bending the inner tube 6 by the index cable 10. Next, the electrode catheter is removed and the balloon 4 is pressed against the target tissue. When the degree of adhesion is low, the internal pressure of the balloon 4, the balloon length, and the pulling degree of the index cable 10 are changed. High-frequency energization is performed for 2 minutes while maintaining the contact surface temperature of the balloon tissue at 60 ° C to 70 ° C. In the experimental data according to this example, if the contact area is wide as 1 cm 2 or more, the depth of heat can easily exceed 1 cm, a transmural necrosis layer can be formed in the ventricular muscle, and ventricular frequent sampling is performed. Can be cured.
[0038]
As described above, it is possible to cure ventricular tachycardia associated with atrial flutter, atrial fibrillation, and organic heart disease, which has been considered to be refractory so far, for more than 2 million patients. It is possible to provide treatment that will be the gospel.
[0039]
【The invention's effect】
As described above, according to the configuration of the present invention, the shape and posture of the balloon can be changed according to the type of the target lesion, so that the adhesion between the target lesion and the balloon is improved and the scorching by high-frequency heating is performed. It can be performed. As a result, it is possible to form a transmural necrotic layer three-dimensionally without risk of thrombus formation or cardiac rupture, and ablation treatment for ventricular tachycardia associated with atrial flutter, fibrillation and 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 multipurpose ablation balloon catheter of the present invention.
FIG. 2 is a view showing an example in which a balloon is made spherical.
FIG. 3 is a diagram showing an example of linear ablation of a tricuspid / large vein vein isthmus for atrial flutter using the balloon shown in FIG. 1;
4 is a three-dimensional schematic diagram illustrating the example illustrated in FIG. 3;
FIG. 5 is a view showing an example of cauterizing the ventricular muscle transmurally without complications using the balloon shown in FIG. 2;
[Explanation of symbols]
1 Balloon catheter 2 Catheter outer tube shaft 4 Balloon 4
6 Catheter inner tube shaft 8 Electrode for high frequency energization 10 Index cable 12 Lead wire 14 Temperature sensor 40 High frequency generator

Claims (7)

A catheter shaft comprising a catheter outer tube shaft and a catheter inner tube shaft slidable with respect to each other;
A contractible and inflatable balloon installed between the distal end portion of the catheter outer tube shaft and the vicinity of the distal end portion of the catheter inner tube shaft having a shape capable of contacting a target lesion in an expanded state;
At least one indexing cable which can be bent by inserting the catheter inner tube shaft into the catheter outer shaft and the distal end portion thereof being fixed and indexed in the vicinity of the distal end portion of the catheter inner tube shaft in the balloon. When,
A high-frequency energizing electrode disposed in the wall of the balloon or in the balloon capable of transmitting high-frequency power to and from a counter electrode disposed on the body surface;
A lead wire electrically connected to the high-frequency energizing electrode;
A temperature sensor capable of monitoring the temperature in the balloon;
A balloon catheter for multipurpose ablation, comprising: The multipurpose ablation balloon catheter according to claim 1, wherein the balloon is made of an antithrombotic resin. The multipurpose ablation balloon catheter according to claim 1, wherein the high-frequency energizing electrode is wound around an outer periphery of the catheter inner tube in the balloon. 2. The multipurpose ablation balloon catheter according to claim 1, wherein high-frequency power is supplied to the high-frequency energization electrode so that the temperature of the balloon becomes a predetermined temperature while monitoring the temperature sensor. 2. The multipurpose ablation according to claim 1, wherein high-frequency power is supplied to the high-frequency energization electrode so that the impedance between the counter electrode and the counter electrode is within a predetermined range. Balloon catheter. 2. The multipurpose ablation balloon catheter according to claim 1, wherein the catheter outer shaft and the balloon are formed of an antithrombotic resin having a smooth surface. The multipurpose ablation balloon catheter according to claim 1, further comprising cooling water perfusion means for perfusing cooling water for suppressing overheating caused by the high-frequency energizing electrode into the catheter inner tube shaft.

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