KR102406831B1 - RF ablation catheter for hypertrophic cardiomyopahty - Google Patents

Abstract

The RF catheter for hypertrophic cardiomyopathy of the present invention comprises: a body forming a catheter body made of a soft soft material; And it is formed in the distal part of the body part, one or more electrodes are formed, a tapered tip that is tapered toward the end is formed, and a guide wire lumen for inserting a guide wire is formed therein. It includes;
Hypertrophic cardiomyopathy procedure using the RF electrode ablation catheter of the present invention comprises the steps of i) positioning a guidewire in the hypertrophied septum through the coronary sinus and septal vein; ii) delivering an RF electrode ablation catheter having a guidewire lumen formed along the guidewire to the enlarged ventricular septum; and iii) while continuously injecting a coolant into the RF electrode ablation catheter, RF energy is applied to the electrode formed at the end of the RF electrode ablation catheter using an RF generator to apply the RF electrode Including; performing resection.

Description

RF ablation catheter for hypertrophic cardiomyopahty

The present invention relates to an RF ablation catheter for hypertrophic cardiomyopathy treatment and a hypertrophic cardiomyopathy procedure using the same. It relates to an RF catheter for hypertrophic cardiomyopathy surgery for performing RF electrode ablation applying energy, and a procedure using the same.

Hypertrophic cardiomyopathy is a heart disease in which the wall of the left ventricle becomes thickened without other symptoms such as aortic valve stenosis or hypertension that may cause left ventricle thickening. It is found in 1 out of 500 people, and various types of left ventricular thickening are observed. The most common and representative features are asymmetrical septal hypertrophy and occlusion (blockage) of the left ventricular outflow tract of variability.

1 is a diagram showing the symptoms of hypertrophic cardiomyopathy and shows a currently generally performed surgical method.

Referring to FIG. 1 , a general method of hypertrophic cardiomyopathy surgery is to insert a knife through the aortic valve into the left ventricle, and then cut out the enlarged left ventricular septum as shown. That is, using a knife, the method of arriving at the enlarged ventricular septum with the sense of a specialist is used.

Meanwhile, as another method, a method using RF energy has been recently announced. Treatment of septal hypertrophy through RF ablation has been frequently reported in the prior art, but these were all methods of performing RF ablation on the surface of the left ventricle by placing a catheter into the left ventricle.

Recently, it has been reported that a technique to use a needle to dig into the inside of the septal hypertrophy rather than the surface has been reported, and it has been reported that it shows a surprisingly good effect. That is, when RF electrode ablation was performed by approaching the intra-septum recently, a very good treatment effect was announced.

(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 disadvantage that it was very dangerous during the procedure because it used a hard needle to access the intra-septum.

Korea 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 (16, October 2018. Presented)

An object of the present invention is to provide an RF ablation catheter of a soft catheter type, not a hard needle, for hypertrophic cardiomyopathy procedure, and using this, intra-myocardial or intraseptal An object of the present invention is to provide a surgical method for obtaining a therapeutic effect for hypertrophic cardiomyopathy.

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

The RF catheter for hypertrophic cardiomyopathy of the present invention comprises: a body forming a catheter body made of a soft soft material; And it is formed in the distal part of the body part, one or more electrodes are formed, a tapered tip that is tapered toward the end is formed, and a guide wire lumen for inserting a guide wire is formed therein. It includes;

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

According to a preferred embodiment, a tip lumen formed inside the tapered tip is in close contact with the guide wire and has a structure without a spaced apart space.

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

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

According to a preferred embodiment, a hydrophilic polymer coating layer is formed on the surface of the septum insertion part except for the surface of the electrode.

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

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

According to a preferred embodiment, a cooling tube capable of injecting a coolant into the guide wire lumen 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 greater thickness than the septum insertion portion, a tapered connection portion is formed between the body portion and the septal insertion portion, and the body portion is the tapered connection portion in the proximal part A lumen for a grounding device into which a separate grounding device can be inserted is formed.

Hypertrophic cardiomyopathy treatment method using the RF electrode ablation catheter of the present invention comprises the steps of i) positioning a guidewire in the hypertrophied septum through the coronary sinus and septal vein; ii) delivering an RF electrode ablation catheter having a guide wire lumen formed along the guide wire to the enlarged ventricular septum; and iii) while continuously injecting a coolant into the RF ablation catheter, RF energy is applied to the RF electrode formed at the end of the RF ablation catheter using an RF generator. Including; performing electrode resection.

According to a preferred embodiment, before the RF electrode ablation is performed in a state where the RF electrode ablation catheter is positioned in the enlarged ventricular septum, the external connector connected to the electrode is connected to an electrical signal analyzer, and the display in the electrical signal analyzer It further comprises the step of determining whether the electrode is located near the His (His bundle) through the analysis of the electrical signal.

According to a preferred embodiment, the method further comprises the step of changing said electrode to a different position away from the hiss when said electrode is located near the hiss.

According to the present invention, there are the following effects.

1. Instead of using a hard needle, RF electrode ablation is performed using a soft RF electrode ablation catheter, so it can smoothly enter along the curved septal vein and can be safely performed. .

2. Passing the RF electrode ablation catheter through the coronary sinus and septal vein to access the LV endocarium past the coronary artery, aortic valve or mitral valve, or direct needle puncture, etc. It is possible to block the complications of the procedure caused by the approach method, etc.

3. Preferably, cooling is performed when RF electrode resection is performed. Through cooling, the risk of char (black dots) or tissue defect occurring in the endocarium can be reduced. .

4. When RF energy is delivered into the ventricular septum, (1) it has good contact with the surrounding tissue (2) it can create a homogenous lesion, which is the advantage of RF energy, and 3) the degree of RF is titrated. ), the degree of tissue damage can be controlled in stages, so it has the advantage of being able to expect a sufficient therapeutic effect even with a structure with a small diameter (about 2 to 6 Fr) that can penetrate the ventricle.

5. At the same time, tissue damage to the inner lining of the ventricle can be avoided, thereby preventing complete atrioventricular block, and since tissue damage occurs uniformly, arrhythmogenecity can be minimized.

6. RF Electrode Ablation The electrode (electrode) formed on the surface of the catheter not only applies RF energy, but also serves as sensing or electrical stimulation.

Before RF electrode resection, the electrical signal of the myocardium is directly sensed through the electrode or electrical stimulation is applied through the electrode. By determining in advance whether or not to do so, it is possible to increase the stability of RF electrode ablation, and thus has the advantage of increasing the reliability of the procedure of the present invention.

1 is a diagram showing the symptoms of hypertrophic cariomypathy and shows a currently generally performed surgical method.
Figure 2 is a schematic diagram showing the RF electrode ablation catheter for hypertrophic cardiomyopathy treatment of the present invention and a procedure using the same.
3 and 4 are schematic views of an RF 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 guiding 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 ablation catheter with a cooling tube inserted into the guidewire lumen according to the present invention.
7 shows a monorail-type RF electrode ablation catheter in which a separate cooling channel other than the guidewire lumen is formed in accordance with the present invention.
8 shows a method of RF ablation using a bipolar mode RF ablation catheter in which electrodes applying different polarities are formed.
9 shows a method of RF ablation using a unipolar mode RF ablation catheter in which an electrode applying a single polarity is formed.
10 shows a method of RF ablation using an RF ablation catheter having a ground-device lumen.
11 is a schematic diagram of an RF ablation catheter with a lumen for a grounding device.

Advantages and features of the present invention and methods of achieving them will become apparent with reference to the embodiments described below in detail in conjunction with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but will be implemented in a variety of different forms, and only these embodiments allow the disclosure of the present invention to be complete, and common knowledge in the technical field to which the present invention belongs It is provided to fully inform the possessor of the scope of the invention, and the present invention is only defined by the scope of the claims.

An important aspect of the present invention is to provide a soft catheter-type RF electrode ablation catheter rather than a hard needle, and to use it to obtain a therapeutic effect for intra-myocardial or intraseptal hypertrophic cardiomyopathy. That is, a method for entering the tissue using a soft catheter rather than a hard needle is proposed.

2 is a schematic diagram showing the RF electrode ablation catheter for hypertrophic cardiomyopathy treatment and the procedure using the same according to the present invention.

Referring to Figure 2, in the present invention, after positioning a guidewire in the enlarged ventricular septum through the coronary sinus and septal vein, RF along the pre-positioned guidewire The ablation catheter is delivered to the treatment target site (ie, enlarged ventricular septum). Then, in a state in which the coolant is continuously injected from the outside, RF energy is applied to the electrode (electrode, 124) formed at the end of the RF electrode ablation catheter using an RF generator to perform RF electrode ablation.

Preferably, before performing RF electrode resection, by using an electrode to sense the electrical signal of the myocardium or by checking the electrocardiogram of the pulsating rhythm generated after applying electrical stimulation, the electrode is The step of determining whether the proximity (close to) His bundle) further comprises the step of determining.

First, a method for positioning the guidewire (10) in the treatment target site (enlarged ventricular septum) will be described.

Using a very thin guide wire (about 0.014"), it passes through the coronary sinus and septal vein and is placed within the hypertrophied septum, the target point.

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 treatment of hypertrophic cardiomyopathy, through a septal vein. Access to the coronary sinus is through the neck vein or femoral vein, and a guide catheter is used through the superior vena cava or inferior vena cava. to access using

The guide catheter utilizes a guide catheter and/or a dual lumen microcatheter formed at the tip of the umbilical cord. The guide catheter is a catheter for guiding the guide wire to a desired position.

When approaching the coronary sinus, a guiding catheter is placed up to the distal part of the coronary sinus, and a pressurized venogram is obtained through the guiding catheter. Conduct. For pressurized venograms, a balloon tipped guiding catheter is ideal.

When septal vein imaging is performed using a pressurized venogram, a PTCA guidewire of about 0.014" is inserted into the septal vein closest to the target site. PTCA Guide The PTCA guidewire utilizes real-time imaging equipment such as echocardiograms to provide more precise imaging guidance that indicates whether the wire is navigating to the target area. In order to more precisely guide the wire, the wire can be precisely guided to the target site using a dual lumen microcatheter.

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

A pressurized venogram is used to better visualize the septal vein. For this purpose, a balloon tipped guiding catheter having a balloon formed at the tip 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. A dual lumen microcatheter is a catheter in which two lumens are formed for insertion of 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 procedure assistance catheter when searching for a target point of a desired guide wire within the ventricular septum.

Free movement of the guidewire is possible without problems such as bleeding in the septal vein located in the ventricular septum tissue rather than the surface of the ventricular septum. Since the septal vein exists in the ventricular septum, the septal vein is used to place the guidewire into the thickened myocardial septum (intra-septum). When using a septal vein, the guide wire can be moved to a desired location through the septal vein as needed. At this time, the dual lumen catheter described above can be used.

A similar approach is theoretically possible using a coronary artery, but it is often difficult to reach the target due to various anatomical locations. In this case, if the guide wire passes through the septal artery, serious problems such as intramyocardial bleeding may occur. In addition, when performing a coronary artery procedure, a thrombus or dissection in the coronary artery occurs frequently, which can be fatal. Therefore, as in the present invention, a guide wire is inserted using a septal vein.

In the present invention, the access method through the septal vein is the left ventricular endocarium (LV endocarium) access, or direct puncture ( It is possible to block complications of the procedure caused by access methods such as direct needle puncture).

Meanwhile, conventionally, there has been a treatment by injecting alcohol into the septal artery. Again, since it is difficult to control the distribution of alcohol, alcohol is delivered to unwanted areas, which can cause unnecessary problems such as myocardial infarction, and also cause conduction system disorders.

Next, the RF ablation catheter is placed along the guidewire placed in the enlarged ventricular septum to the target site (in the enlarged ventricular septum). That is, after positioning one or two or more guide wires in the target site, an RF ablation catheter is inserted along the guide wire, and the electrodes are positioned to reach the target site.

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

With the electrode of the RF electrode ablation catheter positioned at the target site (in the enlarged ventricular septum), while injecting coolant from the outside through the cooling channel or cooling tube in the RF electrode ablation catheter, the RF generator is used. RF electrode ablation is performed by applying RF energy to the electrode formed at the tip of the catheter (RF electrode).

Preferably, before performing the RF electrode resection, a step of determining whether the electrode is located near the myocardial hist is performed. Whether the electrode is positioned near the myocardium can be determined by directly sensing the electrical signal of the myocardium or by checking the electrocardiogram of the beating rhythm generated during electrical stimulation. This will be described later in more detail in relation to the electrode.

3 and 4 are schematic views of the RF electrode ablation catheter for hypertrophic cardiomyopathy, according to the present invention.

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

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

Septal insertion part (intra-septal part, 120) is a part formed in the distal part (distal part) of the body part 130 is a part inserted into the interventricular septum. It has a thickness of about 3 to 6 Fr (preferably about 4 Fr), and is a size that causes less damage to the ventricular septum when inserted into the ventricular septum.

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

Preferably, the length of the tapered tip 122 is about 5 to 20 mm (preferably about 10 mm), and the attachment has a thickness of about 1.2 to 1.4 Fr. The opposite side of the apex has the same thickness (preferably 3~6Fr) as the outer shape of the septal insertion part. The tapered tip 122 is in the shape of a very long, slender tip that is 5-20 times longer than the thickness opposite the attachment (ie, the thickness of the septal insert contour).

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

The guidewire 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. Body lumens correspond to guidewire lumens other than tip lumens.

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 apart.

The tip lumen should be in close contact with the guide wire so that there is no space therebetween, but the body lumen may have a space spaced apart from the guide wire. Preferably, the tip lumen has an inner diameter that is narrower than the body lumen.

The reason why there should not be a gap between the tip lumen and the guide wire is that when the tip enters the ventricular septum, the resistance must be minimized without damaging the ventricular septum tissue. This is because, in the present invention, the tapered tip 122 has to penetrate the interventricular septum tissue while functioning like a needle. If a space is formed between the tip lumen and the guide wire, when the tapered tip is inserted into the ventricular septum, the tip is resisted by the ventricular septum tissue, thereby causing damage to the ventricular septum tissue. 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.

One or more electrodes of the intra-septal part are formed. The electrode not only senses an electrical signal of the myocardium or provides electrical stimulation, but also serves to transmit RF energy of an 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 and exits to the outside of the catheter, and is connected to an external connector. Depending on where the external connector is connected, the electrode performs various functions.

To determine whether it is located near the His bundle of the myocardium (that is, 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 (pacing). do. In addition, in order to perform RF electrode ablation, the electrode is used for transmitting the RF energy of the RF generator. That is, the electrode is used for two purposes: a purpose for determining whether the electrode is located near the His bundle of the myocardium, and a purpose for transmitting RF energy.

First, when used for the purpose of determining whether the electrode is located near the myocardium, it is used to directly sense the electrical signal of the myocardium or to apply electrical stimulation to the myocardium. When electrical stimulation is applied to the myocardium, the position of a conduction system such as hiss can be indirectly determined by checking an electrocardiogram of a beating rhythm generated by the electrical stimulation.

Although RF ablation catheters provide easy access to the ventricular septum, they run the risk of being placed close to the his bundle in the myocardium. If RF ablation is performed while the electrode of the RF electrode ablation catheter is close to the hiss in the myocardium, there is a risk of destroying the heart conduction system by RF ablation of the heart conduction system. have.

In order to prevent this, in the present invention, before performing the RF electrode ablation, the position of the conduction system such as hiss should be grasped through the electrode. To this end, the electrode performs the role of sensing or electrical stimulation (pacing). Conduction of hiss, etc. through the electrocardiogram of the beating rhythm that is generated by using an electrode to directly sense the electrical signal of the myocardium by directly sensing the electrical signal of the myocardium, or by applying electrical stimulation to the myocardium using an electrode The position of the system can be determined indirectly.

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

Only when the position of the electrode is sufficiently deviating from the His bundle, the external connector connected to the electrode is connected to the RF generator and RF energy is applied to perform RF electrode resection.

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

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 pacing. That is, a plurality of electrodes can be divided according to their use, and separated into an electrode used for RF electrode ablation and an electrode used for sensing or electrical stimulation.

As another case, the electrode is not divided into two uses, it is also used for sensing or electrical stimulation, and it can also be used for RF electrode ablation. That is, after the electrode is first used for sensing or electrical stimulation, a connector connected to the electrode may be connected to an RF generator to be used as an electrode for applying RF energy.

In the present invention, the proximal part of the catheter is one end of the catheter, which means the end at which the catheter exits the body, and the distal part of the catheter is the other end of the catheter and refers to the end inserted into the body. .

Although not shown, preferably, the septum insertion part 120 is formed with an insulated spiral coil wire or a braided wire inside. This is to prevent the septal insertion part from being bent when inserted into the ventricular septum (kinking phenomenon), and to improve pushability and trackability. Pushability is the ability to transmit force from the proximal to distal region with reduced bending, and trackability is the ability to deliver catheters along complex blood vessels (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, a surface of the septal insertion portion may be formed with a hydrophilic polymer coating. This is to allow the septal insert to move more easily into the interventricular septum tissue. Since the hydrophilic polymer coating layer is harder than a soft catheter, the septal insertion part can be more easily inserted when inserted into the interventricular septum tissue. Since the electrode must be exposed on the surface, the hydrophilic polymer coating layer is not formed on the portion where the electrode is formed.

The body part (body part, 130) is a part constituting the body of the catheter. The outer diameter of the body portion 130 has a structure equal to or greater than the outer diameter of the septum insertion portion (intraseptal part, 120). The body portion 120 should have sufficient strength to effectively push the catheter from bending (kinking phenomenon) when the septal insertion portion is pushed into the ventricular septum.

Preferably, the same as the septum insertion portion, the body portion may form an insulated spiral coil wire (spiral coil wire) or braided wire (braided wire) inside. This can prevent the catheter from bending, and improve pushability and trackability.

On the other hand, the RF electrode ablation catheter can be divided into a monorail type (or rapid exchange type) and over the wire type (over the wire type) according to the position of the guide wire lumen (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 shown in FIG. 3 has a structure in which the guide wire lumen 110 is formed throughout the catheter in the tip hole 116 that is the inlet side of the tip.

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

Monorail type, over the wire type, both of the above two types are applicable to the RF electrode ablation catheter.

On the other hand, RF electrode ablation using an RF electrode ablation catheter is performed by moving the RF electrode ablation catheter back and forth slightly along the guide wire, or moving it along another guide wire several times until the treatment effect is achieved in various areas. Apply energy to perform RF electrode ablation.

Figure 5 shows the process of guiding 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 myocardium (mycardium) (FIG. 5 (a)). In this state, RF energy can be applied to perform RF electrode ablation.

If you want to move the RF electrode ablation site to another site, remove only the guide wire while leaving the RF electrode ablation catheter as it is (FIG. 5 (b)). Then, the guidewire is sent back in a new direction through the guidewire lumen of the RF ablation catheter (FIG. 5(c)). Since the RF electrode ablation catheter serves to support the guide wire in the myocardium, it is possible to insert the guide wire in a new direction under the support of the RF electrode ablation catheter. By advancing the RF electrode ablation catheter along the guide wire located in the new direction, RF electrode ablation at another site is possible (FIG. 5 (d)).

On the other hand, when RF energy is applied using an RF electrode ablation catheter, if the temperature rises excessively, not only char (black dots) are formed in the ventricular septum, but also tissue defects may appear in the myocardium. . In addition, a sudden rise in intra-tissue pressure as a gas from the sudden burning of the tissue causes a drop in barotrauma, which can lead to a risk of perforation of the heart.

Therefore, preferably, it is necessary to cool the RF electrode resection site using a coolant at the time of RF electrode resection. For cooling, coolant must 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 guidewire lumen, and ii) is discharged to the opposite side of the tip hole of the guidewire lumen. way to do it The method of discharging to the opposite side of the tip hole of the guide wire lumen includes a method of discharging coolant through a side hole and a method of discharging a proximal portion. The method of discharging coolant through the side hole is applied to the monorail type RF electrode ablation catheter, and the method of discharging the coolant to the proximal part is applied to the over the wire type RF electrode ablation catheter.

i) The method in which the coolant is discharged through the tip hole of the guidewire lumen is when the tip end of the RF electrode ablation catheter is located in the right ventricle or left ventricle, not in the ventricular septum. 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 open. Since the tip end is located in the right ventricle or the left ventricle, the coolant injected from the proximal is discharged through the tip hole at the distal end. After the distal end of the catheter is introduced into the right or left ventricle, 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 in close contact with each other, there is almost no space, so it may be difficult for the coolant to escape through the tip hole when the guide wire is inserted into the tapered tip lumen. Because the RF ablation catheter must be inserted into the myocardium along the guidewire, the tapered tip lumen and the guidewire are in close contact, but the RF ablation catheter must move along the guidewire. Therefore, when coolant is injected, a minute gap is generated between the tapered tip lumen and the guide wire by the pressure of the coolant, and it is also possible for the coolant to escape through this minute space.

In the over the wire type RF electrode ablation catheter, a separate cooling channel is not formed, and the guidewire lumen acts as a cooling channel. When the coolant is injected into the guidewire lumen from the proximal part, it is discharged out through the tip hole of the guidewire lumen. At this time, a fine gap is generated between the tapered tip lumen and the guide wire by the pressure of the coolant, and the coolant is discharged through this space. Preferably, before injecting the coolant, the guide wire is withdrawn from the catheter and penetrated through 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 part of the catheter, and a side hole is formed in the middle of the catheter. 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 into the cooling channel from the proximal portion. When coolant is injected into the cooling channel from the proximal part, the coolant exits the lumen of the guidewire connected to the cooling channel. Then, the coolant is discharged through a side hole of the guidewire lumen (see FIG. 7 ). In this case, there is no need to remove the guide wire when injecting coolant.

ii) The method of discharging the guidewire lumen to the opposite side of the tip hole 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 of the distal end is blocked by the ventricular septum. Since the tip hole is blocked by the ventricular septum, coolant cannot be discharged through the tip hole. In this case, the coolant must be discharged through the side hole or the proximal part. The method of discharging coolant through the side hole is applied to the monorail type RF electrode ablation catheter, and the method of discharging the coolant to the proximal part 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, in which coolant is discharged to the proximal part again. That is, FIG. 6 shows a case in which a cooling tube 140 is inserted into the guidewire lumen in the over-the-wire type RF ablation catheter. Insert the cooling tube 140 with an open end 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 guidewire lumen 110 through the open end of the cooling tube. The coolant flowing in the guide wire lumen 110 flows to the opposite side because the tip hole of the guide wire lumen is blocked by the ventricular septum. As a result, the coolant exits proximally along the guidewire lumen. In other words, the coolant injected from the proximal portion through the cooling tube exits the guidewire lumen at the end of the cooling tube, and then exits along the guidewire lumen.

7 is a case of a monorail-type RF electrode ablation catheter, in which coolant is discharged through a side hole. That is, Figure 7 shows a case of forming a separate cooling channel (cooling channel, 150) different from the guide wire lumen in the monorail-type RF electrode ablation catheter. That is, in the monorail-type RF electrode ablation catheter, a cooling channel 150 is formed therein. 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 coolant is injected into the guidewire lumen proximally, the coolant exits the guidewire lumen connected to the cooling channel. The coolant flowing in the guidewire lumen flows to the opposite side because the tip hole of the guidewire lumen is blocked by the ventricular septum. Accordingly, the coolant is discharged through the side hole 118 of the guidewire lumen.

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

A monopolar mode RF ablation catheter is a catheter that applies only the same polarity to all electrodes of an RF ablation catheter, and a bipolar mode RF ablation catheter is a catheter It is a catheter that applies different polarities to the electrodes.

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

In the case of using a monopolar mode RF electrodeablation catheter, there are cases where the grounding device is placed in another part of the body and in the case of placing it within the septum.

When placing the grounding device in another part of the body, place the RF electrode ablation catheter in the ventricular septum, and ground the grounding plate (grounding device) to other parts of the body (body parts such as back, buttocks, calves, etc.) RF electrode ablation This is a method of performing RF electrode ablation by applying RF energy to the electrode of the catheter.

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

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

When using a bipolar mode RF ablation catheter, various polarities of the electrodes can be applied. In the drawings, A, B, C, and D represent electrodes. A-B and C-D may constitute a bipolar pair, AB-CD may constitute a bipolar pair, and A-BCD or ABC-D may constitute a bipolar pair.

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

9 shows a method of RF ablation using a unipolar mode RF ablation catheter in which an electrode applying a single polarity is formed. A ground device is placed in the myocardium. A bipolar electrodeectomy is performed between the RF ablation catheter and the grounding device.

The ground device is a device serving as a ground, and i) a wire having an electrode ii) a microcatheter having an electrode or iii) another RF electrode ablation catheter may be used. The grounding device 200 is a device that is positioned in parallel with the RF electrode ablation catheter in the ventricular septum and serves as a ground (ground), and should have an electrode 210, and the electrode is located in the ventricular septum. The following describes three types used as grounding devices.

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

ii) The 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 in a distal part. An electrode wire is formed inside the catheter, and the distal electrode is connected to the electrode wire. In the proximal part of the electrode wire, an electrical connector is connected to connect to an external power source.

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

On the other hand, in FIG. 9, a method of inserting a grounding device here by forming a separate path for the grounding device is shown, but as in FIG. It is also possible to insert a grounding device through

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

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

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

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

With the septal insertion part of the RF electrode ablation catheter positioned in the ventricular septum, the grounding device is positioned in the ventricular septum through the lumen for the grounding device in the RF electrode ablation catheter.

The RF electrode ablation catheter in which the lumen for the grounding device is formed is convenient for positioning the grounding device in the ventricular septum, and thus has the advantage of being able to perform RF electrodeectomy more conveniently. In addition, bipolar electrode ablation in which the grounding device is placed in the interventricular septum has the advantage of achieving a wider range of RF electrode ablation than monopolar electrode ablation.

As described above, with the electrode of the RF electrode ablation catheter positioned in the ventricular septum, the coolant is inserted into the RF electrode ablation catheter and RF electrode ablation is performed.

After RF electrode ablation is performed to achieve the desired therapeutic effect, all devices are removed.

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

Claims (22)

In the RF catheter for hypertrophic cardiomyopathy,
Body portion forming a catheter body made of a soft soft material; and
Doedoe formed in the distal part of the body portion, one or more electrodes are formed, a tapered tip is formed toward the end, and a guide wire lumen for inserting a guide wire is formed inside, along the guide wire during hypertrophic cardiomyopathy Including a septum insertion unit that is inserted into the interventricular septum
The guide wire lumen is composed of a tip lumen formed inside the elongated tapered tip and a body lumen formed in the body portion and communicated with each other,
The electrode is connected to the RF generator and serves to transmit RF energy and also to sense the electrical signal of the myocardium or to apply electrical stimulation,
The tapered tip has a length of 5 to 20 mm so that it can penetrate through the ventricular septum along the guide wire, the thickness of the attachment is 1.2 to 1.4 Fr, and the opposite side of the tip has a thickness of 3 to 6 Fr Hypertrophic cardiomyopathy procedure for RF catheters. delete According to claim 1,
The tip lumen is in close contact with the guide wire RF catheter for hypertrophic cardiomyopathy, characterized in that there is no spaced apart space. According to claim 1,
The guide wire lumen is formed from the tip hole, which is the end of the tapered tip, to the side hole formed in the middle part of the catheter, or from the tip hole to the proximal part of the catheter. The method of claim 1,
The tip lumen RF catheter for hypertrophic cardiomyopathy treatment, characterized in that it has a narrower inner diameter than the body lumen formed in the body portion. The method of claim 1,
RF catheter for hypertrophic cardiomyopathy surgery, characterized in that the septal insertion portion has a spiral-type coil wire or a braid-type wire formed therein, and the wire is insulated from the electrode. The method of claim 1,
The RF catheter for hypertrophic cardiomyopathy surgery, characterized in that the septal insertion part is formed with a hydrophilic polymer coating layer on the surface except for the surface of the electrode. delete The method of claim 1,
An RF catheter for hypertrophic cardiomyopathy surgery, characterized in that a cooling channel for injecting coolant is formed inside the catheter from the proximal part to the septum insertion part, and the end of the cooling channel communicates with the guide wire lumen. The method of claim 1,
A cooling tube capable of injecting coolant into the guide wire lumen is inserted from the proximal portion to the septum insertion portion,
RF catheter for hypertrophic cardiomyopathy treatment, characterized in that the cooling tube has an open end. The method of claim 1,
The body portion has a thicker thickness than the septum insertion portion,
A tapered connection part is formed between the body part and the septum insertion part,
RF catheter for hypertrophic cardiomyopathy treatment, characterized in that the body portion is formed with a lumen for a grounding device capable of inserting a grounding device from the proximal portion to the tapered connection portion. delete delete delete delete delete delete delete delete delete delete delete

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