KR20200060188A - RF ablation catheter for hypertrophic cardiomyopahty and method for hypertrophic cardiomyopahty in use of it - Google Patents

Abstract

A RF electrode ablation catheter for a hypertrophic cardiomyopathy procedure of the present invention comprises: a body part forming a catheter body made of soft materials; and a septum insertion part formed in a distal portion of the body part, having at least one electrode formed, having a tapered tip tapering toward an end, having a guidewire lumen inside for inserting a guidewire so as to allow insertion into the hypertrophied septum along the guidewire when a hypertrophic cardiomyopathy procedure is performed. A procedure method for hypertrophic cardiomyopathy using the RF electrode ablation catheter of the present invention comprises the steps of: i) positioning a guidewire in an enlarged hypertrophied septum through the coronary sinus and septal vein; ii) delivering the RF electrode ablation catheter having a guidewire lumen to the enlarged hypertrophied septum along the guidewire; and iii) in the state of continuously injecting a coolant into the RF electrode ablation catheter, using a RF generator to apply RF energy to an electrode formed at an end of the RF electrode ablation catheter so as to perform RF electrode ablation.

Description

RF ablation catheter for hypertrophic cardiomyopahty and method for hypertrophic cardiomyopahty in use of it

The present invention relates to an RF ablation catheter for hypertrophic cardiomyopathy and a method for the treatment of hypertrophic cardiomyopathy using the same. An RF catheter for the treatment of hypertrophic cardiomyopathy for performing RF electrodeectomy applying energy and a method of using the same.

Hypertrophic cardiomyopathy is a heart disease in which the left ventricular wall is thickened without other symptoms such as aortic stenosis or hypertension that can cause left ventricular thickening. It is found in 1 in 500 people, and various types of left ventricular thickening are observed. The most common and typical features are asymmetrical septal hypertrophy and obstruction of the left ventricle effusion (clogging and blockage) of variability.

FIG. 1 is a diagram showing symptoms of hypertrophic cardiomyopathy and shows currently performed surgical methods.

Referring to FIG. 1, a general method of hypertrophic cardiomyopathy is a method of inserting a knife through the aortic valve into the left ventricle and then cutting the enlarged left ventricular septum as shown. In other words, a method of using a knife to reach the ventricular septum enlarged with the sense of a specialist is used.

Meanwhile, a method of using RF energy as another method has been recently announced. The treatment of septal hypertrophy through RF ablation has often been published in the past, but it was a method of performing RF electrode ablation on the left ventricle surface by placing a catheter into the left ventricle.

Recently, a technique has been reported that uses a needle to dig into the surface rather than the surface of sepal hypertrophy, and it has been reported to have surprisingly excellent effects. That is, when RF electrodeectomy was performed recently approaching the intra-septum, a very good result was reported.

(Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy.Journal of the American College of Cardiology Volume 72, Issue 16, October 2018)

However, in the above paper, there was a drawback that it was very dangerous during the procedure by approaching the intra-septum using a solid needle.

Korean Registered Patent Publication No. 10-1626958 (registered on May 27, 2016) (high frequency catheter with multiple electrodes)

Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy. Journal of the American College of Cardiology Volume 72 (Announced 16, October 2018)

An object of the present invention is to provide an RF ablation catheter of a soft catheter type, rather than a rigid needle, for the treatment of hypertrophic cardiomyopathy, and using this, intra-myocardial or intraseptal. It is to provide a treatment method for obtaining the therapeutic effect of hypertrophic cardiomyopathy.

The objects of the present invention are not limited to the objects mentioned above, and other objects not mentioned will be clearly understood by those skilled in the art from the following description.

RF catheter for the treatment of hypertrophic cardiomyopathy according to the present invention comprises a body portion forming a soft soft material catheter body; And formed on the distal portion of the body, at least one electrode is formed, tapered tip is formed tapering toward the end, the guide wire lumen to insert the guide wire is formed inside, guide wire during hypertrophic cardiomyopathy It includes; the septum insertion portion is inserted into the ventricular septum.

According to a preferred embodiment, the electrode is connected to the RF generator and serves to transmit RF energy, and also serves to sense the electrical signal of the myocardium or to apply electrical stimulation.

According to a preferred embodiment, the tip lumen formed inside the tapered tip has a structure that is in close contact with each other with the guide wire and has no separation space.

According to a preferred embodiment, the guide wire lumen is formed from a tip hole, which is an end of the tapered tip, to a side hole formed in the middle of the catheter, or is formed by hanging from the tip hole to the proximal portion of the catheter.

According to a preferred embodiment, the interstitial insertion portion or the body portion is formed of a spiral type coil wire or a braid type wire therein, and the wire is insulated from the electrode.

According to a preferred embodiment, the hydrophilic polymer coating layer is formed on the surface portion excluding the surface of the electrode.

According to a preferred embodiment, the tapered tip has a length of 5 to 20 mm, the attachment has a thickness of 1.2 to 1.4 Fr, and the opposite side has a thickness of 3 to 5 Fr.

According to a preferred embodiment, inside the catheter, a cooling channel capable of injecting coolant is formed from a proximal portion to the septum insertion portion, and an end of the cooling channel communicates with the guide wire lumen.

According to a preferred embodiment, inside the guide wire lumen, a cooling tube capable of injecting coolant is inserted from the proximal portion to the septum insertion portion, and the cooling tube has an open end.

According to a preferred embodiment, the body portion has a thicker thickness than the septum insertion portion, a tapered connection portion is formed between the body portion and the septum insertion portion, and the body portion is tapered at the proximal part. A lumen for a grounding device is formed to insert a separate grounding device.

The method for the treatment of hypertrophic cardiomyopathy using the RF electrode ablation catheter of the present invention includes: i) positioning a guidewire in a hypertrophied septum enlarged through a coronary sinus and a septal vein; ii) passing the RF electrode ablation catheter with the guide wire lumen formed along the guide wire to the enlarged ventricular septum; And iii) in a state in which a coolant is continuously injected into the RF electrode ablation catheter, RF energy is applied to an RF electrode formed at an end of the RF electrode ablation catheter using an RF generator to perform RF. And performing electrode resection.

According to a preferred embodiment, the RF electrode ablation catheter is placed in the enlarged ventricular septum, before RF electrode ablation is performed, an external connector connected to the electrode is connected to an electrical signal analyzer, and displayed on the electrical signal analyzer. Further comprising the step of determining whether the electrode is located near the heat (His bundle) through the analysis of the electrical signal to be.

According to a preferred embodiment, when the electrode is located near the heath, the method further includes changing the electrode to another position away from the heath.

According to the present invention has the following effects.

1. Rather than using a solid needle, RF electrodeectomy is performed using a soft RF electrodeectomy catheter, allowing smooth entry through the curved ventricular septal vein to safely perform the procedure. .

2. Passing the RF electrode ablation catheter through the coronary vein and the septal vein, accessing the LV endocarium past the coronary artery, aortic valve or mitral valve, or direct needle puncture. It can block complications of the procedure caused by the approach.

3. Preferably, cooling is performed when RF electrodeectomy is performed, so that the risk of char (black spots) or tissue defects in the endocarium can be reduced through cooling. .

4. When RF energy is delivered within the ventricular septum, (1) good contact with surrounding tissue (2) can create a homogenous lesion, an advantage of RF energy, and 3) titration of RF ), It is possible to control the degree of tissue damage step by step, so even a small diameter (about 2 to 6 Fr) structure that can penetrate into the ventricle has the advantage that a sufficient therapeutic effect can be expected.

5. At the same time, it is possible to avoid damage to the tissue of the lining of the alert chamber, thereby preventing complete atrioventricular blockage and to minimize arrhythmogenecity as tissue damage occurs uniformly.

6. RF electrode ablation The electrode (electrode) formed on the surface of the catheter plays a role of sensing or electric stimulation as well as applying RF energy.

Before RF electrodeectomy, the electrode is sensed directly through the electrode, or after applying electrical stimulation through the electrode, the electrode is positioned close to the heart muscle's His bundle through the electrocardiogram of the rhythm. By determining whether or not in advance, it is possible to increase the stability of the RF electrode pre-treatment, and thus has the advantage of increasing the reliability of the procedure of the present invention.

FIG. 1 is a diagram showing symptoms of hypertrophic cariomypathy and shows currently performed surgical methods.
Figure 2 is a schematic diagram showing the RF electrode ablation catheter for the treatment of hypertrophic cardiomyopathy of the present invention and a method using the same.
3 and 4 are schematic diagrams of an RF electrode ablation catheter for hypertrophic cardiomyopathy according to the present invention, and FIG. 3 shows an over the wire type RF ablation catheter, and FIG. 4 Shows a monorail type RF ablation catheter.
Figure 5 shows a process of inducing the guide wire again in a different direction using the over-the-wire type RF electrode ablation catheter according to the present invention.
6 shows an over the wire type RF electrode ablation catheter with a cooling tube inserted into a guide wire lumen according to the present invention.
7 shows a monorail type RF electrode ablation catheter in which a guide wire lumen and another separate cooling channel are formed according to the present invention.
8 shows a method of RF electrode ablation using a bipolar mode RF electrode ablation catheter in which electrodes that apply different polarities are formed.
9 illustrates a method of RF electrode ablation using a monopolar mode RF electrode ablation catheter in which an electrode that applies a single polarity is formed.
FIG. 10 shows a method of RF electrode ablation using an RF electrode ablation catheter having a ground-device lumen.
11 is a schematic diagram of an RF electrode ablation catheter having a lumen for a grounding device.

Advantages and features of the present invention, and methods for achieving them will be clarified with reference to embodiments described below in detail together with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but will be implemented in various different forms, and only the embodiments allow the disclosure of the present invention to be complete, and the ordinary knowledge in the technical field to which the present invention pertains. It is provided to fully inform the holder of the scope of the invention, and the invention is only defined by the scope of the claims.

An important aspect of the present invention is a procedure method for providing a soft catheter type RF electrode ablation catheter rather than a rigid needle, and using this to obtain an intra-myocardial or intraseptal hypertrophic cardiomyopathy treatment effect. That is, a method for entering the tissue using a soft catheter rather than a rigid needle is presented.

Figure 2 is a schematic diagram showing the RF electrode ablation catheter for the treatment of hypertrophic cardiomyopathy of the present invention and a method using the same.

Referring to FIG. 2, the present invention places a guidewire through a coronary sinus and a septal vein in a hypertrophic ventricular septum, and then moves the RF along a pre-positioned guidewire. The electrodeectomy catheter is delivered to the treatment target site (ie, enlarged ventricular septum). Then, in the state in which a coolant is continuously injected from the outside, RF electrode ablation is performed by applying RF energy to an electrode (124) formed at the end of the RF electrode ablation catheter using an RF generator.

Preferably, before performing the RF electrodeectomy, the electrode is used to sense the electrical signal of the myocardium by sensing the electrical signal of the myocardium using an electrode, or by checking the electrocardiogram of the rhythmic rhythm generated after applying electrical stimulation, so that the electrode is a heath of the myocardium ( His bundle) is further determined to determine whether the proximity (close location).

First, a description will be given of a method of positioning the guide wire 10 within the treatment target region (hyperventricular septum).

A very thin guidewire (around 0.014 ") is placed through the coronary sinus and septal vein and positioned within the targeted hypertrophied septum.

In the present invention, a coronary sinus having an opening in the right atrium is used to access the enlarged ventricular septum, which is the purpose of treating hypertrophic cardiomyopathy through septal vein. Access to the coronary sinus uses a neck vein or femoral vein, and a guiding catheter through the superior vena cava or the inferor vena cava. To access.

The guide catheter uses a guide catheter and / or a dual lumen micro catheter formed at the end of the wind. The guide catheter is a catheter for guiding the guide wire to a desired position.

When the coronary sinus is approached, the guiding catheter is positioned to the distal part of the coronary sinus, and a pressurized venogram is applied through the guiding catheter. Conduct. For pressurized venograms, a balloon tipped guiding catheter is ideal.

When contrasting the vein through the pressurized venogram, approximately 0.014 "PTCA guidewire is inserted into the coronary vein closest to the target site. PTCA Guide PTCA guidewire utilizes real-time imaging equipment such as ultrasound (echocardiogram) to enable more precise treatment with imaging guidance that tells if the wire is going to the target site. In order to induce more precisely, a dual lumen microcatheter can be used to precisely guide the wire to the target site.

That is, in order to position the guide wire to the ventricular septum through the septal vein, (1) pressurized venogram with balloon guiding cathether and / or using a guide catheter with a balloon at its tip. Or (2) a dual lumen microcathehter.

Pressurized venograms are used to make the septal vein more visible. To this end, a balloon-tipped guiding catheter may be used as an auxiliary means.

In addition, a dual lumen microcatheter or the like may be used as an auxiliary means to position the guidewire in a desired direction within the ventricular septum. The dual lumen microcatheter is a catheter in which two lumens are formed to insert a guide wire. After placing the first guidewire in the septal vein through the first lumen of the dual lumen microcatheter, the second guidewire is inserted through the second lumen of the dual lumen microcatheter. The second guide wire can be moved in a different direction than the first guide wire. As such, the dual lumen micro-catheter is a very useful surgical assistant catheter when searching for a target point for a desired guidewire within the ventricular septum.

In the septal vein located in the ventricular septum tissue rather than the ventricular septum surface, free movement of the guidewire is possible without problems such as bleeding. Since the septal vein is present in the ventricular septum, the guidewire is placed into the thickened myocardial septum using the septal vein. When using the septal vein, it is possible for the guide wire to penetrate the septal vein and move to the desired place, if necessary. At this time, the dual lumen catheter described above may be used.

A similar approach is theoretically possible with the use of a coronary artery, but the anatomical position is often difficult to reach the target. In this case, if the guide wire penetrates the septal artery, serious problems such as intramyocardial bleeding may occur. In addition, when a procedure is performed with a coronary artery, thrombus or dissection in the coronary artery often occurs, which can be fatal. Therefore, as in the present invention, the guide wire is inserted using a septal vein.

In the present invention, the approach through the septal vein is a conventional approach, a coronary artery, an aortic valve, or a mitral valve that passes through the left ventricle lining (LV endocarium), or a direct puncture ( Complications of the procedure caused by the approach, such as direct needle puncture) can be blocked.

On the other hand, conventionally, it has been treated to inject alcohol into the septal artery. This, too, is difficult to control the distribution of alcohol, and alcohol is delivered to unwanted areas, which can lead to problems such as unnecessary myocardial infarction, and also to cause disorders of the conduction system.

Next, the RF ablation catheter is positioned along the guidewire positioned in the enlarged ventricular septum to the target site (in the enlarged ventricular septum). That is, after placing one or two or more guide wires on the target site, an RF electrode ablation catheter is inserted along the guide wire to position the electrode to reach the target site.

The RF electrode ablation catheter 100 has a guide wire lumen formed therein, a tapered tip 122 is formed at a distal end, and one or more electrodes 124 are formed on the surface. The more detailed structure of the RF electrode ablation catheter will be described later.

Using the RF generator while injecting coolant from the outside through the cooling channel or cooling tube in the RF electrode ablation catheter, with the electrode of the RF electrode ablation catheter positioned at the target site (in the enlarged ventricular septum). RF electrode ablation The RF electrode is excised by applying RF energy to an electrode formed at the end of the catheter.

Preferably, before performing RF electrodeectomy, a step of determining whether the electrode is located near the heath of the myocardium is performed. Whether the electrode is located near the heath of the myocardium is possible by directly sensing the electrical signal of the myocardium or by checking the electrocardiogram of the rhythm of rhythm generated during electrical stimulation. This will be described later in more detail with respect to the electrode.

3 and 4 is a schematic diagram of the RF electrode ablation catheter for the treatment of hypertrophic cardiomyopathy according to the present invention.

The RF electrode ablation catheter 100 is formed with a guide wire lumen 110 into which a guide wire is inserted, a tapered tip 122 is formed at a distal end, and one or more electrodes (electrode, 124) are formed on the surface. ) Is formed.

The RF electrode ablation catheter 100 is largely divided into a body part (130) and an intra-septal part (120).

The intra-septal part 120 is a part formed in the distal part of the body 130 and is a part inserted into the ventricular septum. It is about 3 ~ 6Fr thick (preferably about 4Fr) and is less sized to damage the ventricular septum when inserted into the ventricular septum.

The intra-septal part 110 includes an electrode (124) having one or more electrodes formed on the surface, and a tapered tip (122) tapering toward the end.

Preferably, the length of the tapered tip 122 is approximately 5-20 mm (preferably approximately 10 mm), and the attachment has a thickness of approximately 1.2-1.4 Fr. The opposite side of the attachment has the same thickness (preferably 3 to 6 Fr) as the outer shape of the septum insert. The tapered tip 122 is a very long, thin tip shape that is 5-20 times longer than the thickness of the opposite side of the attachment (i.e., the thickness of the septum insert).

RF ablation catheter (RF ablation catheter 100) has a guide wire lumen (guidewire lumen) is inserted into the guide wire, so that it can be inserted into the ventricular septum along the guide wire located in the ventricular septum. A tip hole 116 is formed at the end of the septum insert. The tip hole (116) is connected to the guide wire lumen.

The guide wire lumen is divided into a tip lumen formed inside the tapered tip and a body lumen formed in the body portion. The tip lumen and the body lumen are in communication. The body lumen corresponds to a guidewire lumen other than the tip lumen.

Preferably, when the guide wire is inserted into the tip lumen, the tip lumen 112 and the guide wire 10 are in close contact with each other so that there is no space for separation.

The tip lumen should be in close contact with the guide wire and have no space therebetween, but the body lumen may have a space between the guide wire and the guide lumen. Preferably, the tip lumen has a narrower inner diameter than the body lumen.

The reason that there should be no space between the tip lumen and the guide wire is that when the tip enters the interior of the ventricular septum, resistance should be minimized without damaging the ventricular septum tissue. This is because, in the present invention, the tapered tip 122 has to function as a needle and have to twist the ventricular septum tissue. If, when a space between the tip lumen and the guide wire is formed, when the tapered tip is inserted into the ventricular septum, the tip is resisted by the ventricular septum, thereby causing a problem that the ventricular septum can be damaged. do.

Since the RF electrode ablation catheter must be inserted into the ventricular septum along the guide wire, the tip lumen and the guide wire are in close contact, but the RF electrode ablation catheter must be movable along the guide wire.

At least one electrode of the intra-septal part is formed. The electrode not only serves to sense the electrical signal of the myocardium or to provide electrical stimulation, but also serves to transmit RF energy of the RF generator.

The electrode is connected to an internal electrode wire (not shown), and the electrode wire is connected to the proximal part along the inside of the catheter, exits the outside of the catheter, and is connected to an external connector. Depending on where the external connector is connected, the electrodes perform various functions.

In order to determine whether it is located near the myocardial hiss bundle (i.e., to determine the location of the conduction system), the electrode is used to directly sense the electrical signal of the myocardium or to apply electrical stimulation. do. In addition, in order to perform RF electrode ablation, the electrode is used for transmitting RF energy of the RF generator. That is, the electrode is used for two purposes: to determine whether the electrode is located near the heath (His bundle) of the myocardium and to transmit RF energy.

First, when the electrode is used to determine whether or not it is located near the heath of the myocardium, it is used to directly sense the electrical signal of the myocardium or to apply electrical stimulation to the myocardium. In the case of applying electrical stimulation to the myocardium, it is possible to indirectly grasp the position of a conduction system such as heath by checking the electrocardiogram of the rhythm of rhythm generated by electrical stimulation.

The RF electrodeectomy catheter has easy access to the ventricular septum, but there is a risk of being positioned close to the hiss in the myocardium. If RF ablation is performed while the electrode of the RF electrode ablation catheter is close to the heath in the myocardium, there is a risk of destroying the heart's conduction system by RF ablation of the heart's conduction system. have.

In order to prevent this, in the present invention, before performing RF electrode ablation, the position of a conductive system such as heath must be grasped through the electrode. To this end, the electrode serves as sensing or electrical stimulation. Conducting the electrical signal of the myocardium by using an electrode to directly detect the electrical signal of the myocardium to determine the location of the conduction system, or by applying an electrical stimulus to the myocardium using an electrode, conduction such as heath through electrocardiogram of the rhythm generated accordingly The location of the system can be indirectly identified.

If the electrode is located near the heath, the position of the RF electrode ablation catheter should be changed to another position. A method of changing the RF electrode ablation catheter to a different position will be described later.

Only when the position of the electrode is sufficiently displaced from the heath (His bundle), the external connector connected to the electrode is connected to the RF generator to apply RF energy to perform RF electrodeectomy.

When RF ablation is performed, a connector connected to the electrode is connected to the RF generator. The RF energy of the RF generator is transferred to the electrode to perform RF ablation.

Since one or more electrodes are formed, some of the electrodes may be used for RF electrode ablation, and the remaining electrodes may be used for sensing or electrical stimulation. That is, a plurality of electrodes can be classified according to their use, and can be used separately as an electrode used for RF electrode ablation and an electrode used for sensing or electric stimulation.

As another case, the electrode is not divided into two uses, but can also be used for sensing or electric stimulation, and also for RF electrode ablation. That is, after the electrode is first used for sensing or electrical stimulation, the connector connected to the electrode can be used as an electrode to apply RF energy by connecting to the RF generator.

In the present invention, the proximal part of the catheter is the one end of the catheter, which means the end of the catheter exiting the outside of the human body, and the distal part of the catheter is the other end of the catheter, which means the end that is inserted into the body. .

Although not shown, preferably, the interstitial insert 120 is formed with an insulated spiral coil wire or a braided wire. This is to prevent the kinking phenomenon when the septal insertion part is inserted into the ventricular septum, and to improve the pushability and the tackability. Pushability is the ability to transmit forces from the proximal to the distal while reducing bending, and trackability is the ability to inject a catheter along a complex blood vessel (Pushability is often understood as the ability to transmit force from the proximal end of the catheter to the distal end of the catheter while minimizing or eliminating kinking.Trackability is often understood as the ability to navigate the catheter through tortuous vasculature). It goes without saying that both the spiral type coil wire and the braid type wire must be insulated from the electrode or the electrode wire.

Preferably, the septum insert may have a hydrophilic polymer coating on its surface. This is to make the septal insert easier to move into the ventricular septum tissue. Since the hydrophilic polymer coating layer is harder than a soft catheter, the septal insert can be more easily inserted when inserted into the ventricular septal tissue. Since the electrode should be exposed on the surface, a hydrophilic polymer coating layer is not formed in the portion where the electrode is formed.

The body part (130) is a part constituting the body of the catheter. The outer diameter of the body portion 130 has the same or larger structure than the outer diameter of the septum inserting portion (intraseptal part, 120). The body portion 120 must have sufficient stiffness to efficiently push the catheter so that the catheter does not bend when the septal insert is pushed into the ventricular septum.

Preferably, in the same way as the septum insert, the body portion may be formed of an insulated spiral coil wire or a braided wire. This can prevent the catheter from bending, and can improve pushability and trackability.

Meanwhile, the RF electrode ablation catheter can be divided into a monorail type (or rapid exchange type) and an over the wire type according to a position where a guidewire lumen is formed.

3 shows an over the wire type RF ablation catheter, and FIG. 4 shows a monorail type RF ablation catheter.

The over-the-wire type RF electrode ablation catheter illustrated in FIG. 3 is a structure in which the guide wire lumen 110 is formed over the entire catheter in a tip hole 116 which is an entrance side of a tip.

In the monorail type RF electrode ablation catheter shown in FIG. 4, the guide wire lumen 110 is formed from a tip hole (116) at the entrance side of the tip to a side hole (118) in the middle of the catheter. Structure. The tip hole 116 is formed at the end of the tapered tip 122. The side hole 118 may be formed in an intra-septal part, or may be formed in a body part, or may be formed in a tapered connection part connecting the body part and the septum insertion part. have.

Both the monorail type, over the wire type, and the above two types are applicable to RF electrode ablation catheters.

On the other hand, RF electrode resection using the RF electrode ablation catheter moves the RF electrode ablation catheter back and forth slightly along the guide wire, or by moving it along the other guide wire several times until the treatment is effective in several areas. RF electrodeectomy is performed by applying energy.

5 shows a process of inducing the guide wire again in a different direction using the RF electrode ablation catheter according to the present invention.

First, the RF electrode ablation catheter 100 along the guide wire 10 enters the mycardium (Fig. 5 (a)). In this state, RF electrode resection can be performed by applying RF energy.

If the RF electrode ablation site is to be moved to another site, only the guide wire is removed with the RF electrode ablation catheter intact (FIG. 5 (b)). Then, the guide wire is sent again in a new direction through a guidewire lumen of the RF electrode ablation catheter (Fig. 5 (c)). The RF electrode ablation catheter in the myocardium (myocadium) serves to support the guide wire, and thus the guide wire can be inserted in a new direction under the support of the RF electrode ablation catheter. Along the guide wire positioned in the new direction, the RF electrode ablation catheter is advanced to allow RF electrode ablation at other sites (FIG. 5 (d)).

On the other hand, when RF energy is applied using an RF electrode ablation catheter, when the temperature rises excessively, not only char (black dots) are formed in the ventricular septum, but tissue defects may appear in the myocardium. . In addition, the pressure in the tissue suddenly rises with the gas that comes out of the sudden burning of the tissue, which causes a risk of perforation of the heart.

Therefore, preferably, the RF electrode ablation site should be cooled using a coolant during RF electrode ablation. In order to cool, coolant should be injected into the RF electrode ablation catheter.

Depending on where the tip hole of the catheter is located during RF electrode ablation, i) the coolant is discharged through the tip hole of the guide wire lumen, and ii) the opposite side of the tip hole of the guide wire lumen. Is the way to do it. There are two methods of discharging to the opposite side of the tip hole of the guide wire lumen: the coolant is discharged to the side hole and the proximal portion is discharged. The coolant discharge method is applied to the monorail type RF electrode ablation catheter, and the proximal discharge method is applied to the over the wire type RF electrode ablation catheter.

i) Coolant is discharged through the tip hole of the guide wire lumen. When the tip end of the RF electrode ablation catheter is located in the right ventricle or the left ventricle, not the ventricular septum. Is used. That is, it is used when the tip hole of the tip end is not blocked by the ventricular septum, that is, the tip hole of the tip end is opened. Since the tip end is located in the right ventricle or the left ventricle, the coolant injected from the proximal exits through the tip hole of the distal end. The distal end of the catheter is introduced into the right ventricle or left ventricle, and then a coolant (e.g. saline solution or cooled saline solution) is continuously flowed. Then, the coolant continuously flows to the right ventricle or the left ventricle where the catheter distal end is located.

Since the tapered tip lumen and the guide wire are closely spaced, there is little space, and when the guide wire is inserted into the tapered tip lumen, coolant may not escape through the tip hole. Since the RF electrode ablation catheter must be inserted into the myocardium along the guide wire, the tapered tip lumen and the guide wire are in close contact, but the RF electrode ablation catheter must move along the guide wire. Therefore, when the coolant is injected, a fine separation occurs between the tip lumen and the guide wire tapered by the pressure of the coolant, and it is also possible for the coolant to escape through the fine separation space.

In the over the wire type RF electrode ablation catheter, a separate cooling channel is not formed, and the guide wire lumen serves as a cooling channel. When a coolant is injected into the guide wire lumen at the proximal portion, it is discharged out through the tip hole of the guide wire lumen. At this time, a fine separation occurs between the tip lumen tapered by the coolant pressure and the guide wire, and the coolant escapes through the separation space. Preferably, before injecting the coolant, it is preferable to remove the guide wire from the catheter to penetrate the tip hole. Then, the coolant is more easily discharged through the tip hole.

In the monorail type RF electrode ablation catheter, the guide wire lumen is not connected to the proximal portion of the catheter, and since a side hole is formed in the middle of the catheter, a separate cooling channel from the proximal portion to the septum insertion portion is provided. To form. The cooling channel is formed to pass through the electrode, and the end of the cooling channel is connected to the guide wire lumen. The coolant is injected proximally into the cooling channel. When a coolant is injected from the proximal part into the cooling channel, the coolant comes out as a guide wire lumen connected to the cooling channel. Then, the coolant is discharged through the side hole of the guide wire lumen (see FIG. 7). In this case, it is not necessary to remove the guide wire when the coolant is injected.

ii) The method of discharging to the opposite side of the tip hole of the guide wire lumen is when the tip end of the RF electrode ablation catheter is located within the ventricular septum. That is, it is used when the tip hole at the distal end is blocked by the ventricular septum. Coolant cannot be discharged through the tip hole because the tip hole is blocked by the ventricular septum. In this case, coolant should be discharged to the side hole or proximal part. The coolant discharge to the side hole is applied to the monorail type RF electrode ablation catheter, and the discharge to the proximal portion is applied to the over the wire type RF electrode ablation catheter.

6 is a case of an over the wire type RF electrode ablation catheter, where the coolant is discharged back to the proximal portion. That is, FIG. 6 shows a case in which a cooling tube 140 is inserted into the guide wire lumen in the over the wire type RF electrode ablation catheter. The cooling tube 140 with an open end is inserted into the guide wire lumen. The cooling tube is made of soft plastic. When the coolant is injected proximally through the cooling tube 140, the coolant flows into the guide wire lumen 110 through the open cooling tube end. The coolant flowing in the guide wire lumen 110 flows in the opposite direction because the tip hole of the guide wire lumen is blocked by the ventricular septum. As a result, the coolant exits the proximal part along the guide wire lumen. In other words, the coolant injected proximal through the cooling tube exits from the end of the cooling tube to the guide wire lumen and then exits along the guide wire lumen.

7 is a case of a monorail type RF electrode ablation catheter, in which a coolant is discharged to a side hole. That is, FIG. 7 illustrates a case in which a separate cooling channel 150 is formed different from a guide wire lumen in a monorail type RF electrode ablation catheter. That is, in the monorail type RF electrode ablation catheter, a cooling channel 150 is formed inside. The cooling channel 150 is formed to pass through the electrode 124, and an end of the cooling channel 150 is connected to the guide wire lumen 110. When a proximal portion is injected with a coolant into the guidewire lumen, the coolant comes out as a guidewire lumen connected to the cooling channel. The coolant flowing in the guide wire lumen flows in the opposite direction as the tip hole of the guide wire lumen is blocked by the ventricular septum. Therefore, the coolant is discharged through the side hole (118) of the guide wire lumen.

On the other hand, depending on the method of applying a potential during RF electrode ablation, a method using a monopolar mode RF ablation catheter and a bipolar mode RF ablation catheter are used. There is a way to use it.

The monopolar mode RF ablation catheter is a catheter that applies only one polarity to all electrodes of the RF electrode ablation catheter, and the bipolar mode RF ablation catheter is a catheter. It is a catheter that applies different polarity to the electrode.

A separate grounding device is not required when using the bipolar mode RF ablation catheter, but a separate grounding device is required when using the single polarity mode RF ablation catheter.

When using a single-polarity mode RF ablation catheter, there are cases where the grounding device is placed in another part of the human body and within the central septum.

When placing the grounding device on another part of the human body, place the RF electrode ablation catheter in the ventricular septum, and after grounding the grounding plate (grounding device) on another part of the human body (body parts such as back, hip, and calf), RF electrode ablation This method performs RF electrode ablation by applying RF energy to the electrode of the catheter.

When the grounding device is positioned within the ventricular septum, the RF electrode ablation catheter is placed in the ventricular septum, and then positioned around the electrode of the RF electrode ablation catheter of the ground device serving as ground, and then the electrode of the RF electrode ablation catheter. It is a method of applying RF energy to RF electrode ablation. This method will be described with reference to FIGS. 10, 11, and 12.

8 shows a method of RF electrode ablation using a bipolar mode RF electrode ablation catheter in which electrodes that apply different polarities are formed. In this case, a separate ground device is not required, and only one RF electrode ablation catheter is used.

When using a bipolar mode RF electrode ablation catheter, the polarity of the electrode can be applied in various ways. In the figure, A, B, C, and D represent electrodes. A-B and C-D may form a bipolar pair, AB-CD may form a bipolar pair, and A-BCD or ABC-D may form a bipolar pair.

As shown in FIG. 8, since a plurality of electrodes are widely spread in a bipolar mode RF electrode ablation catheter, RF electrode ablation is performed over a wide area when RF energy is applied.

9 illustrates a method of RF electrode ablation using a monopolar mode RF electrode ablation catheter in which an electrode that applies a single polarity is formed. A ground device is placed in the myocardium. Bipolar electrodeectomy is performed between the RF electrodeectomy catheter and the grounding device.

The ground device is a device that serves as a ground, i) a wire having an electrode, ii) a microcatheter having an electrode, or iii) a separate RF excision catheter. The grounding device 200 is a device that serves as a ground by being positioned in a balance with the RF electrode ablation catheter within the ventricular septum, and must have an electrode 210, and the electrode is positioned within the ventricular septum. The following describes the three types used as grounding devices.

i) A wire with an electrode is a thin wire type, and one or more electrodes are formed on a distal part. The part except the electrode is insulated. An electrical connector is connected to the proximal to connect to an external power source.

ii) A micro catheter having an electrode is a catheter type having a thickness of about 2 to 6 Fr, and one or more electrodes are formed on a distal part. An electrode wire is formed inside the catheter, and the electrode of the distal portion is connected to the electrode wire. In the proximal portion, an electrical connector is connected to connect an external power source.

iii) A separate RF electrode ablation catheter can also be used as a grounding device to act as a ground.

On the other hand, FIG. 9 shows a method of inserting a grounding device into a separate path by forming the grounding device, but as shown in FIG. 10, the RF electrode ablation catheter without inserting the grounding device into a separate path. You can also insert the grounding device through.

FIG. 10 shows a method of RF electrode ablation using an RF electrode ablation catheter having a ground-device lumen, and FIG. 11 is a schematic diagram of an RF electrode ablation catheter having a ground device lumen. The lumen for the grounding device is applied to both the monorail type RF electrode ablation catheter described above and the over the wire type RF electrode ablation catheter. Although the over the wire type RF electrode ablation catheter is illustrated in FIG. 11, the present invention is not limited thereto, and is applied to a monorail type RF electrode ablation catheter. In FIG. 11, the aforementioned cooling tube or cooling channel is omitted.

Referring to FIGS. 10 and 11, a ground-device lumen 160 for inserting a grounding device into an RF electrode ablation catheter is separately formed. The lumen for the grounding device is a lumen for inserting the grounding device. The lumen for the grounding device is formed from the proximal portion of the catheter (the portion where the grounding device is inserted) to the distal portion of the catheter (the portion where the grounding device exits).

Preferably, in order to form a separate lumen for a grounding device in the catheter, the body portion must be thicker than the septum insertion portion. To this end, preferably, the RF electrode ablation catheter of the present invention is formed with a tapered connection part (170) between the body portion and the septum insertion portion. The ground device lumen 160 is connected from the proximal portion to the connection portion 170. Preferably, the lumen for the grounding device is formed from the proximal portion to the connecting portion, and the grounding device is inserted from the proximal portion and exits from the connecting portion. 11 shows that the lumen 160 for the ground device is formed up to the connection unit 170, and the ground device 200 is released from the connection unit. The body part of the RF electrode ablation catheter is inserted up to the coronary vein, and the septal insert passes through the coronary vein and is inserted into the septal vein.

As the grounding device inserted into the lumen for the grounding device, a microcatheter having i) an electrode ii) an electrode as described above is used.

With the septum insertion portion of the RF ablation catheter positioned at the ventricular septum, the grounding device is positioned at the ventricular septum through the lumen for the grounding device in the RF ablation catheter.

The RF electrode ablation catheter with a lumen for a grounding device is convenient to place the grounding device at the ventricular septum, and thus has the advantage of being able to perform RF electrodeectomy more easily. In addition, bipolar electrodeectomy in which the grounding device is positioned within the ventricular septum has the advantage that RF electrode ablation is performed in a wider range than monopolar electrodeectomy.

As described above, while the electrode of the RF electrode ablation catheter is positioned within the ventricular septum, RF electrode ablation is performed while a coolant is inserted into the RF electrode ablation catheter.

All devices are removed after RF electrodeectomy is performed to achieve a sufficiently targeted therapeutic effect.

Although the embodiments of the present invention have been described with reference to the above and the accompanying drawings, those of ordinary skill in the art to which the present invention pertains can implement the present invention in other specific forms without changing its technical spirit or essential features. You will understand that there is. Therefore, it should be understood that the embodiments described above are illustrative in all respects and not restrictive.

10: guide wire
100: RF ablation catheter
110: guidewire lumen
112: tip lumen
114: body lumen
116: tip hole
118: side hole
120: intra-septal part
122: tapered tip
124: electrode
130: body part
140: cooling tube
150: cooling channel (cooling device)
160: ground-device lumen
170: connect part
200: ground device
210: electrode

Claims (22)

In the RF catheter for the treatment of hypertrophic cardiomyopathy,
A body part forming a catheter body made of soft soft material; And
It is formed on the distal portion of the body, at least one electrode is formed, tapered tip is formed tapering toward the end, the guide wire lumen is formed to insert the guide wire inside, along the guide wire during hypertrophic cardiomyopathy procedure RF catheter for the treatment of hypertrophic cardiomyopathy, characterized in that it comprises a; interstitial insertion portion inserted into the ventricular septum. According to claim 1,
The electrode is RF RF catheter for hypertrophic cardiomyopathy, characterized in that it is connected to the RF generator and serves to transmit RF energy, and also performs a role of sensing an electrical signal of the myocardium or applying an electrical stimulus. According to claim 1,
The tip lumen (tip lumen) formed inside the tapered tip is a RF catheter for hypertrophic cardiomyopathy, characterized in that there is no separation space in close contact with the guide wire. According to claim 1,
The guide wire lumen is formed from the tip hole, which is the tip end of the tapered tip, to the side hole formed in the middle of the catheter, or from the tip hole to the proximal portion of the catheter, the entire catheter is formed, and the RF catheter is used for hypertrophic cardiomyopathy. According to claim 1,
The tip lumen is an RF catheter for hypertrophic cardiomyopathy, characterized in that it has a narrower inner diameter than the body lumen formed on the body portion. According to claim 1,
The interstitial insertion portion is formed in a spiral-type coil wire or braid-type wire therein, the wire is RF catheter for hypertrophic cardiomyopathy, characterized in that is insulated from the electrode. According to claim 1,
The septal insertion portion RF surface catheter for hypertrophic cardiomyopathy, characterized in that a hydrophilic polymer coating layer is formed on the surface portion except the surface of the electrode. According to claim 1,
The tapered tip is 5 ~ 20mm in length, the attachment is 1.2 ~ 1.4Fr thickness, the other side of the attachment has a thickness of 3 ~ 6Fr RF catheter for the treatment of hypertrophic cardiomyopathy. According to claim 1,
Inside the catheter, a cooling channel capable of injecting a coolant is formed from the proximal portion to the septum insertion portion, and an end of the cooling channel is in communication with the guide wire lumen. According to claim 1,
Inside the guide wire lumen, a cooling tube capable of injecting coolant is inserted from the proximal portion to the septum insertion portion,
The cooling tube is an RF catheter for hypertrophic cardiomyopathy, characterized in that the end is open. According to claim 1,
The body portion has a thicker thickness than the septum insertion portion,
A tapered connection portion is formed between the body portion and the septum insertion portion,
The body portion RF catheter for hypertrophic cardiomyopathy, characterized in that a lumen for a grounding device is formed to insert a grounding device from the proximal portion to the tapered connection. In the method of hypertrophic cardiomyopathy using RF electrode ablation catheter,
i) positioning the guidewire in the hypertrophied septum enlarged through the coronary sinus and septal vein;
ii) passing the RF electrode ablation catheter with the guide wire lumen formed along the guide wire to the enlarged ventricular septum; And
iii) In a state in which coolant is continuously injected into the RF electrode ablation catheter, RF electrode ablation is performed by applying RF energy to an electrode formed at the end of the RF electrode ablation catheter using an RF generator. Step; Hypertrophic cardiomyopathy procedure method comprising a. The method of claim 12,
Before performing the electrodeectomy,
Determining whether the electrode is located near a heath bundle of the myocardium by checking the electrocardiogram of the rhythm of rhythm caused by the electrode directly sensing an electrical signal of the myocardium or applying an electrical stimulation through the electrode. In addition, The method of claim 13,
When the electrode is located near the heath of the myocardium, the method further comprising the step of changing the electrode to another position away from the heath. The method of claim 12,
Further comprising the step of changing the RF electrode ablation catheter to another location within the ventricular septum,
The step of changing to the other location,
Step of entering the RF electrode ablation catheter in the mycardium (mycardium) along the guide wire,
Removing only the guide wire while leaving the RF electrode ablation catheter intact,
Sending a guidewire in a new direction through a guidewire lumen of the RF electrode ablation catheter, and
And moving the RF electrode ablation catheter along the guide wire positioned in the new direction to position the RF electrode ablation catheter at a different location. The method of claim 12,
The RF electrode ablation catheter
A body part forming a catheter body made of soft soft material; And
It is formed on the distal portion of the body, at least one electrode is formed, a tapered tip tapering toward the end is formed, a guide wire lumen for inserting the guide wire is formed inside the guide wire during hypertrophic cardiomyopathy Including, but not limited to, the interstitial insert inserted into the ventricular septum
The tapered tip lumen inside the tapered tip is in close contact with each other with the guide wire, characterized in that there is no space for hypertrophic cardiomyopathy. The method of claim 16,
The tapered tip is 5 to 20 mm long, the attachment is 1.2 to 1.4Fr thick, and the other side of the attachment has a hypertrophic cardiomyopathy procedure characterized in that it has a thickness of 3 to 5Fr. The method of claim 12,
Inside the catheter, a cooling channel capable of injecting coolant is formed from a proximal portion to the septum insertion portion, and an end of the cooling channel is in communication with the guide wire lumen,
The coolant is injected from the proximal portion of the cooling channel and discharged to the outside through the guide wire lumen, or through a side hole formed in the side surface of the RF electrode ablation catheter. . The method of claim 12,
Inside the guide wire lumen, a cooling tube capable of injecting coolant is inserted from the proximal portion to the septum insertion portion, and the cooling tube has an open end,
The coolant is injected from the proximal portion of the cooling tube and discharged to the outside through the guide wire lumen, or through a side hole formed in the side surface of the RF electrode ablation catheter. . The method of claim 12,
The RF electrode ablation catheter is a bipolar mode RF electrode ablation catheter having two or more electrodes to which different polarities are applied. The method of claim 12,
Further comprising the step of placing a grounding device on the enlarged ventricular septum,
The RF electrode ablation catheter is a single polarity mode RF electrode ablation catheter having an electrode to which a single polarity is applied,
The grounding device is a wire having an electrode, a micro catheter having an electrode, or a separate RF electrode ablation catheter. The method of claim 12,
Further comprising positioning a grounding device within the enlarged ventricular septum,
The RF electrode ablation catheter is a single-polarity mode RF electrode ablation catheter, and a method for treating hypertrophic cardiomyopathy characterized in that a lumen for a grounding device capable of inserting the grounding device is formed.

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