JPH09173343A - Non-surgical mapping for atrial arrhythmia and induced introducer shaped for medical treatment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To exactly arrange a catheter inside the heart by inserting an induced introducer, to which a bent shape is applied, having the through lumen, inserting the catheter for cutting and/or mapping into the induced introducer and inducing it into an atrium. SOLUTION: This induced introducer for forming a track 8 inside the right atrium is divided into two sections, the respective sections are connected to the other sections, and one continuous induced introduced preferably formed through a single producing process is formed. The 1st area of induced introducer for right atrium is a normal straight and slender hollow induced introducer area and has a length enough for introduction into a patient and operation from the spot of insertion to any specified desired position inside the right atrium of the heart. A 2nd area connected to the distant terminal part of the 1st area of the induced introducer is made into a bent part bent to left. Further, a 3rd area connected to the distant terminal part of the 2nd area of the induced introducer is composed of an almost straight section turned at about 40 deg.-60 deg. from the direction of the 1st area.

Description

Detailed Description of the Invention

[0001]

The present invention relates to atrial arrhythmia using a catheter guided by a shaped guiding introducer.
Mapping and treatment methods. The present invention also relates to a preferred configuration of a guiding introducer for use with a mapping or ablation catheter for mapping or treatment of atrial arrhythmias.

[0002]

Introducers and catheters have been used for many years in medical procedures. For example, one of its uses is to deliver electrical stimulation to specific sites within the human body. Another application is to monitor and measure for diagnostic tests in the body. That is, the catheter can reach internal body parts (eg, the heart) that are otherwise inaccessible without otherwise more invasive procedures (eg, incision). It can be placed at a specific site in the body that is difficult to access, and during that period examination, diagnosis and treatment can be performed with a catheter. In use, the catheter may be inserted into a major vein or artery near the body surface. Then, by manipulating the catheter, the catheter is guided to a specific site for examination, diagnosis or treatment through an artery or vein in the body.

Catheters are becoming increasingly useful in remote and hard-to-reach areas of the body. However, the use of such catheters is often limited by the need to accurately position (position) the electrodes of the catheter at specific sites within the body.

It is difficult to control the movement of the catheter to obtain the above accurate positioning due to the inherent structure of the catheter. The body of a conventional catheter is a long tubular body. In order to have sufficient control over the movement of the catheter, its structure must have some degree of rigidity. On the other hand, the catheter must not be so stiff that it impedes the bend in the catheter necessary to move the catheter through veins, arteries, or other body parts to reach the desired specific site. Furthermore, the catheter must not be so stiff that it damages the arteries and veins while it is being moved within the body.

While it is important that the catheter is not stiff enough to damage the blood vessel, torque (rotational force)
It is also important that the catheter has sufficient rigidity for its control, ie the ability to transmit torsional forces along the length of the catheter. With sufficient torque control,
The twisting force applied to the proximal (front side) end of the catheter
By traveling along the catheter to its distal end,
Controlled steering of the catheter is possible. The need for greater torque control often conflicts with the need for reduced stiffness to prevent vessel injury.

Catheters are increasingly used in medical procedures involving the human heart. In such procedures, a catheter is typically delivered through a vein or artery to the heart and positioned at a particular location within the heart. Typically, a catheter is inserted into a patient's leg, neck, upper chest or arm artery or vein, often using a guidewire or introducer to guide and pass through various arteries or veins. , Advance until the tip of the catheter reaches the desired site in the heart.

The distal end of the catheter used for such treatment may be curved in advance to a desired curved shape. With this preforming, the catheter can be guided to a desired site in the heart or an artery or vein associated with the heart by rotating the catheter about its axis.

For example, US Pat. No. 4,882,777 discloses a complex curved distal end catheter for use in certain procedures in the right ventricle of a human. U.S. Pat.Nos. 5,299,574 and 4,117,836 disclose catheters for use in selective coronary angiography of the left coronary artery, and U.S. Pat.
Nos. 5,540, 5,016,640 and 4,883,058 disclose catheters for selective coronary angiography of the right coronary artery. See also U.S. Pat. No. 4,033,031.

US Pat. No. 5,269,326 discloses a pericardial spa through the right atrium for certain medical procedures.
(Ce) is disclosed by a method of transvenous access. U.S. Pat. No. 4,898,591 discloses a catheter having an inner layer and an outer layer (having a braided portion). This U.S. Pat. No. 4,898,591 also discloses a number of different curved shapes for intravascular catheters. U.S. Pat.No. 5,231,99
No. 4, No. 4,838,879, No. 5,171,232 and No.
See also No. 5,290,229.

Atrial fibrillation is the most common persistent arrhythmia. It is estimated to occur in approximately 0.4% of the adult population and perhaps 10% of the population over the age of 60. Cox,
JL et al., Electrophysiology, Pacing and Arrhyt
hmia , ` ` Operations for Atrial Fibri
See, Clin. Cardiol., 14, 827-834 (1991).

Atrial arrhythmias can be either transient or permanent. Many atrial arrhythmias occur in individuals with another underlying form of heart disease, but some atrial arrhythmias occur independently. Atrial arrhythmias rarely lead to death as directly as ventricular arrhythmias, but many other diseases include stroke, thrombosis, atherosclerosis,
It increases the risk factors for systemic and cerebral embolisms, further causing many medical problems.

In the treatment of atrial fibrillation, antiarrhythmic drugs may provide symptomatic relief. Antiarrhythmic drugs include, for example, U.S. Patent Nos. 4,558,155, 4,500,529, and 4,
No. 988,698, No. 5,286,866 and No. 5,215,989. The treatment of atrial arrhythmias by means of medication has been disclosed in many medical articles and books, including, for example: Martin, D., et al., Atrial Fibrillation (A
trial Fibrillation), pp. 35-41 (1994); Falk, RH,
et al., Atrial Fibrillation (1992); Singe
r, I., et al., Clinical Manual of Electrophysiology (Clinical
Manual of Electorophysiology ) (1993); and Horow
itz, LN, Current Management of A
rrhythmias ) (1991).

Another treatment for atrial arrhythmias or atrial fibrillation is the use of implantable atrial defibrillators, or cardioversion. For example, US Pat.
See 836, 5,271,392 and 5,209,229. Martin, D., et al., Atrial Fibrillation
on), pp. 42-59 (1994).

However, some patients with symptomatic atrial arrhythmia or life-threatening atrial arrhythmia cannot be sufficiently treated with drugs or the above medical devices. In that case, other forms of aggressive treatment, including surgery, are required. For example, a surgical procedure for the treatment of atrial arrhythmias called the Maze method is described by Cox, JL eta.
L., Electrophysiology, Pacing and Arrhythmia , Treatment of Atrial Fibrillation, Clin. Cardiol., 14, 827-834 (1991). Cox, JL et al., `` The Surgical Treatment of Atrial Fibrillatio
n) '' The Journal of Thoracic and Cardiovascular Sur
gery , Vol.101, No.4, pp.584-592, 569-583 (April 1991
Mon), and Cox, JL et al., “The Surgical Treatment of Atrial Fibrillation,” The Journal of Thoracic and Cardiovascular Surg.
See also ery , Vol.101, No.3, pp.406-426 (March 1991). Other surgical procedures for atrial arrhythmias include, for example:
Martin, D., et al., Atrial Fibrillation , pp.54-56 (1994).

Another treatment method that has been used for the last 10 to 15 years for certain types of non-atrial cell arrhythmias, ie, non-atrial arrhythmias, is catheter ablation. is there. This procedure has been used to interrupt or alter the transmission pathways that are associated with ventricular arrhythmias within the heart. The specific site to cut depends on the type of underlying ventricular arrhythmia.

One of the common amputation procedures is the atrioventricular (AV)
It is for treatment of nodular tachycardia. In this problem, cutting fast or slow AV nodal pathways has become an acceptable treatment. Singer, I., et al., “Catheter Ablation for Arrhythm
ias) '' Electrophysiology Clinical Manual (1993); Falk, R.
H., et al., Atrial Fibrillat Management Mechanism (Atrial Fibrillat
ion Mechanisms in Management) , pp.359-374 (1992);
Horowitz, LN, Modern Arrhythmia Management , pp.373-378 (1991);
And Martin, D., et al., Atrial Fibrillation , pp. 42-59 (199
See 4). The use of cutting catheters for cutting locations within the heart is described, for example, in U.S. Pat.
No. 263,493, No. 5,231,995, No. 5,228,442 and No. 5,281,217. However, none of these disclose the use of a guide introducer to guide the cutting catheter to a particular location.

The source of energy used to cut the catheter is not constant. Initially, the use of high voltage direct current (DC) cutting was common. However, due to the problems associated with the use of direct current, radio frequency (RF) cutting has become the preferred energy source for the cutting process. The use of high frequency energy for cutting is described, for example, in US Pat.
4,945,912, 5,209,229, 5,281,218,
No. 5,242,441, No. 5,246,438, No. 5,281,213
And No. 5,293,868. Other sources of energy that have been considered for cutting heart tissue include lasers, ultrasound, microwaves, and fulgutronization.

[0018]

In order to cut an accurate position in the heart, it is necessary to place the cutting catheter in the correct position in the heart. Accurate positioning of the cutting catheter is particularly difficult in view of the physiology of the heart, especially because the cutting procedure is generally performed while the heart is beating. In general, catheter placement is determined by a combination of electrophysiological guidance and fluoroscopy (catheter placement is based on known anatomy, such as coronary sinus, high right atrium and right ventricle). To a known site of the heart marked by placing a radiopaque diagnostic catheter inside or on the mechanical structure).

Although this method was useful for certain arrhythmias, the use of catheter ablation within the atrium to treat atrial fibrillation has never been disclosed. The closest one is AV nodule or His-Purkin
je) Bundle catheter cutting procedures are described, for example, in US Pat.
1,649 and Martin, D., et al., Atrial Fibrillation , p. 53 (1
994).

It is an object of the present invention to disclose a method for mapping and treating atrial arrhythmias using a cutting catheter guided in a specific location by a shaped guide introducer.

Another object of the present invention is to disclose a method of cutting a defined track in the left and / or right atrium as a component of the treatment of atrial arrhythmias.

Yet another object of the present invention is the treatment of atrial arrhythmias for atrial mapping and left atrium and / or
Or to disclose a shaped guide introducer used in combination with a catheter for cutting a defined track in the right atrium.

Another object of the present invention is to provide a specially shaped guide introducer for use in electrophysiological procedures for the treatment of atrial arrhythmias.

[0024]

The above and other objects can be achieved by the presently disclosed method of treating atrial arrhythmia and the shaped introducer introducer used in the method.

In one aspect, the invention is a method of treating and / or mapping atrial arrhythmias using a mapping and amputation catheter. This method has a lumen that penetrates from one end to the other end, introduces a mapping or cutting catheter inside a shaped guide introducer and introduces it into the atrium, and maps or cuts a predetermined position in the atrium. Consists of doing.

In a preferred embodiment of the invention, the amputation and / or mapping procedure for the treatment of atrial arrhythmia comprises the following steps. (a) has a lumen that penetrates from one end to the other end, and introduces a shaped guide introducer into the right atrium of a human, (b) using the shape-provided guide introducer in the right atrium Positioning the cutting and / or mapping catheter with a portion thereof protruding from the tip of the lumen of the guide introducer,
(c) cutting and / or mapping a predetermined track in the right atrium using a cutting and / or mapping catheter placed inside a shaped guide introducer, and (d) the same or different from above. Reintroduction in the right atrium by repeating steps (a), (b) and (c) using a shaped guided introducer and cutting and / or mapping multiple predetermined tracks in the right atrium. Circuit (reentry circ
(e) introduce a shaped guide introducer into the human left atrium with a lumen penetrating from one end to the other, and (f) this shape-guided lead introduction. Position the catheter for cutting and / or mapping in the left atrium with a device so that a part thereof projects from the tip of the lumen of the guide introducer, and Cutting and / or mapping a predetermined track in the left atrium using a cutting and / or mapping catheter placed inside, and (h) using the same or another shaped guiding introducer as described above. (e), (f) and
By repeating (g) and cutting and / or mapping a plurality of predetermined tracks in the left atrium, the reintroduction circuit in the left atrium is reduced or eliminated, thereby achieving a degree of atrial contraction and atrioventricular synchronization. While forming a generally uninterrupted path or corridor of electrical impulses from the sinus node to the atrioventricular node.

The present invention, in another aspect, discloses a shaped guide introducer for use with a mapping and / or cutting catheter in the mapping and / or treatment of atrial arrhythmias. Specifically, five types of guided introducers each having a different shape are disclosed for treatment in the left atrium, and four types of guided introducer are disclosed for treatment in the right atrium. It

[0028]

DETAILED DESCRIPTION OF THE INVENTION The normal human heart has a right ventricle, a right atrium, a left ventricle and a left atrium. The right atrium is in fluid communication with the superior and inferior vena cava. The atrioventricular septum separates the right atrium and the right ventricle. A tricuspid valve contained within the atrioventricular septum connects the right atrium and the right ventricle. The inner wall of the right atrium, which is in contact with the left atrium, has a thin dented portion, which is the fossa ovalis. A detailed explanatory view of the right atrium is shown in FIG. 1, and a detailed explanatory view of the left atrium is shown in FIG.

In the fetal heart, the fossa ovalis (open ostium) is open so that fetal blood can flow between the right and left atrium. For most people, this opening closes after birth, but for as many as 25 percent,
Instead of the fossa ovalis between the right and left atrium, an opening (open foramen) still remains. There is an opening or mouth to the coronary sinus between the fossa ovalis and the tricuspid valve. The coronary sinus is the great epicardial vein that houses most of the venous blood drained from the myocardium into the right atrium.

In the normal heart, the contraction and relaxation of the myocardium (myocardium) occur regularly, which means that electrochemical signals are transmitted within the myocardium from the sinoatrial (SA) node to the atrioventricular (AV) node,
It occurs as a result of sequential flow to the left and right ventricles along distinct pathways including the His-Perkinje system. The first electrical stimulation
It occurs in the SA node and is transmitted to the AV node. The AV node lies near the opening of the coronary sinus in the atrial septum of the right atrium. Hiss
The Perkinje system begins at the AV node, proceeds along the membranous atrial septum toward the tricuspid valve, and passes through the atrioventricular septum into the membranous ventricular septum. About the middle of the ventricular septum, the His-Perkinje system branches left and right, straddling the apex of the muscle part of the ventricular septum.

An abnormal rhythm sometimes called atrial arrhythmia occurs in the atrium. The three most common types of arrhythmia are ectopic atrial tachycardia, atrial fibrillation, and atrial flutter. Atrial fibrillation causes significant discomfort to the patient and is sometimes fatal.
The reason is that atrial fibrillation has many accompanying problems including (1) to (3) below. (1) Irregular heart rate causes discomfort and anxiety, (2) Loss of synchrony of atrioventricular contractions, and unstable blood circulation in the heart, resulting in various levels of congestive heart failure. 3) Thromboembolism increases the susceptibility to thromboembolism due to cessation of blood circulation (congestion).

Although it may be difficult to determine the specific pathological cause of atrial fibrillation, the main mechanism (cause) is
Are considered to be one or more reentry circuits formed in the left and / or right atrium. As a conventional attempt to alleviate the above problems, the use of pharmacological treatment has been conspicuous. While pharmacological treatments are sometimes effective, in some cases drug treatments are ineffective and often suffer from side effects including dizziness, nausea, visual impairment and other symptoms.

Surgical procedures have also been used for the treatment of atrial arrhythmias in the last few years. The goal of this surgical procedure, as in the case of pharmacological treatment, is to reduce the subjective symptoms of atrial arrhythmia and normalize hemodynamics by restoring regular atrial effects on cardiac output. , And both. One proposed method requires surgical isolation of the left atrium from the rest of the heart. Cox, JL et
al., “Surgical Treatment of Atrial Fibrillation,” Journal of Thoracic
and Cardiovascular Surgery , Vol. 101, No.4, p. 570
See (1991).

The initial incision is scar tissue after such surgery.
It leaves behind (scar tissue), effectively isolates the left atrium and in some cases reduces some of the patient's subjective symptoms. Such relief can occur only if the right atrium maintains a sufficient sinus rhythm. In addition to the need to maintain proper sinus rhythm, this treatment is accompanied by various problems, including the risk of thromboembolism.

Another treatment for the treatment of atrial arrhythmias is cutting the His bundle. A permanent pacemaker is then implanted to produce regular ventricular beats. Cox, J.
L. et al., “Surgical Treatment of Atrial Fibrillation,” Journal of Thora
cic and Cardiovascular Surgery , Vol. 101, No. 4, p
See pages 570-572 (1991). However, atrial fibrillation may still persist, normal cardiac hemodynamics may not be restored, and the risk of thromboembolism still remains.

A newer surgical procedure proposed by Guiraudon in 1985 creates a narrow corridor between the SA and AV nodes. Guiraudon,
GM, et al., " Separation of combined sinus / atrioventricular nodules: atria
Surgical alternative to His bundle cutting in patients with fibrillation (Comb
ined Sinoatrial Node / Atrial Ventricular Node Isola
tion: a Surgical Alternative to His Bundle Ablatio
n in Patients with Atrial Fibrillation '', Circurat
See ion 72: (pt-2) III-220 (1985). This action
It separates the narrow corridor from the rest of the atrial musculature, potentially alleviating some of the problems associated with atrial arrhythmias.

More recently, a more complex surgical procedure called the "Maze" procedure has been proposed for the treatment of atrial arrhythmias. Cox, JL et al., Surgical Treatment of Atrial Fibrillation, Journal of Thoracic and Cardiovascular Sur
See gery , Vol. 101, pp. 569-83 (1991). In this procedure, an atrial incision is made at the appropriate location to interrupt the transfer path of the area within the atrium that produces the most common reintroduction circuit. This procedure is also intended to direct sinus stimulation from the sinus node to the AV node along a particular path. In addition, the entire atrial myocardium (excluding left and right atrial appendages and pulmonary veins)
It is also intended to be rendered electrically active by providing multiple blind alleys off the main transduction pathway between the SA and AV nodes, thereby preserving post-operative atrial transport function. To be done. Although this treatment method has given good therapeutic results in some patients, it has a high potential risk due to the large area of surgery.

The effectiveness of the "Maze" method is that certain lines are used to prevent the formation of reintroduction circuits while still allowing atrial contraction and returning to normal atrioventricular transmission.
It relies on destroying the tissue in the atrium along the track. It has been found that a similar success can be achieved with an intra-atrial cutting (ablation) procedure, without invasive surgery. However, in order to perform this cutting procedure, the cutting catheter is positioned at a predetermined position in the left and right atrium, and a predetermined track (line or trajectory) is cut in the left and right atrium, thereby forming a reintroduction circuit. It is necessary to form a natural barrier against It is necessary to form a cut track in well-defined locations in the left and right atrium, and to form a proper transmural lesion, the electrodes of the cutting catheter and the heart tissue to be cut are to be formed. It is important to maintain sufficient contact pressure in between.

The cutting catheter used for this cutting procedure produces scar tissue at a predetermined position in the atrium. The energy needed to damage or cut tissue can come from many diverse sources. Initially, direct current was used to obtain energy for cutting treatment. More recently, radio frequency (RF) has become the preferred energy source of choice. Laser, microwave, ultrasonic and fulgulization means have also been used to perform the cutting procedure. The preferred energy source for the cutting process of the present invention is radio frequency energy.

One of the significant difficulties encountered in performing any cardiac procedure within the atrium is due to the physiology of the atrium itself during beating (especially when the beating is abnormal). Therefore, a preferred procedure for creating cutting tracks in the left and right atrium requires accurate positioning and proper contact pressure of the cutting catheter in the atrium to cut a given track in atrial tissue. The wound or track created with this procedure may be at the same location as the "maze" incision, but may be created at different locations within the atrium with similar results. .

Even if a cutting catheter is simply introduced into the left or right atrium without accurate positioning and proper contact pressure,
It would not be possible to form the desired cutting track. This precise positioning and proper contact pressure allows the cutting catheter to be guided to the correct position so as to produce a properly cut track, and a special pressure can be applied to the tip of the cutting catheter. This can only be achieved by using a guiding introducer with a curved shape.

Elements of the treatment of atrial arrhythmias also include sensing position within the atrium to efficiently and accurately map the atrium. The physiological function of the heart and its pulsation also hinder the effectiveness of the mapping catheter.
The guide introducer of the present invention can also assist in the accurate placement of such mapping catheters.

Doctors often monitor the introduction of a cardiac catheter into the vascular system and its advancement within the blood vessel using a fluoroscope. Unfortunately, fluoroscopy devices generally cannot readily identify a particular shape within the heart, specifically the critical structures of the left and right atrium. Therefore, it is extremely difficult to arrange and use the cutting catheter unless a curved guide introducer is used.
Catheter placement is particularly challenging because the beating heart is constantly moving and the catheter moves within the atrium while blood is being pushed out of the heart. The structure and shape of the guiding introducer of the present invention addresses and solves these problems and allows for the correct catheter placement required for a correct cutting procedure.

The guiding introducer of the present invention performs the positioning function of automatically positioning the mapping and / or cutting catheter as a result of its shape in the exact location required for the procedure. This specially shaped (shaped) guide introducer is made from a conventional elongate catheter. Although the guide introducer of the present invention has a plurality of compartments (regions) as described below, it is preferably manufactured into a single integral structure by a conventional method for manufacturing a guide introducer. . In addition to its unique curved shape, the guide introducer of the present invention has a radiopaque tip marker and an evacuation hole that will be described in more detail below.

In the preferred embodiment, one guide introducer is used to assist the cutting catheter in cutting a particular track in either the left or right atrium, but more than one guide introduces. The devices may be used in combination to form an appropriately shaped guide introducer. For example, the first shape-provided induction introducer is disposed inside the second shape-provided induction introducer, and the combination shape of the first and second guidance introducers is the first shape. And a plurality of different shapes depending on the degree of rotation of each second induction introducer and the degree of insertion of the inner (first) induction introducer into the interior of the outer (second) induction introducer. May be.

When using a single, different guide introducer for each procedure, each guide introducer is used separately to guide the catheter along an individual track. After holding the cutting catheter at a predetermined position by using a guide introducer having a curved shape in advance, a predetermined cutting track is cut by using the cutting catheter. More than one cutting operation along a track may be required to completely cut the track.

Sensing elements located within the catheter can also be used to sense activity along the track. After the cutting procedure is completed, the used guide introducer with the first shape is taken out, the guide introducer with the second shape is inserted in its place, and the procedure using the cutting catheter is repeated. Form a cutting track. The above procedure is continued until all predetermined cutting tracks have been completely cut in the heart. The choice of which shaped guide introducer to use first and in what order is, of course, up to the individual physician.

The choice of tracks to cut in the left and right atrium is generally determined from the experimental and clinical data collected so far for that patient. For example, Cox,
JL et al., “Surgical Treatment of Atrial Fibrillation” Journal of Tho
racic and Cardiovascular Surgery , Vol. 101, pp. 40
See 6-426 (1991). However, the position of the cutting tracks and the number of cutting tracks (the number of cutting tracks) are clearly within the discretion of the doctor. For example, Scheinman
" Catheters for the control of refractory supraventricular arrhythmias
Catheter-Induced Ablation o
f the Atrioventricular Junction to Control Refract
ory Supraventicular Arrhythmias) '', JAMA 248: 851-
5 (1982), the cutting track can also be selected to completely separate the left atrium. Or,
Giraudon is Guiraudon, GM, etal., "Combination Horayui
Node / atrioventricular nodule separation: His bundle cutting in patients with atrial fibrillation
Alternative Surgical Procedure , Circuration 72: (pt-2) III-220
As suggested in (1985), the cutting track can also be selected to form a "corridor" between the atrioventricular and AV nodules.

Although the amputation and mapping procedure may begin first in either the left or right atrium, it is preferred that the procedure begin in the right atrium prior to the transatrial septum. The amputation procedure in the right atrium is specifically designed to prevent or delay the onset of atrial flutter. It also aids in the treatment of other atrial arrhythmias. The cutting track that forms in the right atrium is designed so that reintroduction circuits do not form especially around the superior vena cava, inferior vena cava and right atrial appendage.
FIG. 1 is an illustration showing a preferred cutting track formed in the right atrium shown as tracks 5, 6, 7, 8, 9. Depending on the physician's choice, more or less tracks may be created. The choice of which track to form first is also at the discretion of the physician.

The cutting track in the atrial septum of the right atrium, shown as track 8, is preferably formed at the same time as the corresponding cutting track in the atrial septum of the left atrium.
See track 8 in FIG. 1, track 8 in FIG. 2, and FIGS. The preferred procedure for forming these cutting tracks is an intercatheter cutting method using two catheters, as shown in FIG. In this method, the first catheter uses a particularly preferred guiding introducer for the left atrium, and the second catheter uses a particularly preferred guiding introducer for performing a cutting procedure along the atrial septum of the right atrium. . The track of the right atrium is located above the fossa ovalis and septal roo
f), reaching the track formed by the first guiding introducer for the left atrium (track 1 in FIG. 2) and the track 6 in FIG. 1 formed in the right atrium. This is possible because the left and right atrial tracks are on either side of the atrial septum. These tracks are preferably formed after forming the remaining right tracks.

Since this procedure for the right atrium can be performed using conventional fluoroscopy, it is not necessary to use a specially shaped guiding introducer for the procedure, but along the track 8 of the right atrium. It is preferable to use a guide introducer having a small curvature in order to guide the catheter. See FIG.

The guide introducer for forming this track 8 in the right atrium is preferably divided into two parts. Preferably each section is connected to the other section, preferably forming a continuous induction introducer formed in a single fabrication process. See Figures 14A-14B and Figures 11 and 12.
This induction introducer is the same as the induction introducer shown in FIG. 2 of Japanese Patent Application No. 5-354369 filed by the present applicant.

More specifically, the guide introducer for the right atrium is composed of three regions, a first region, a second region and a third region. The first region of this guide introducer is the normal, generally straight, elongated hollow guide introducer region, sufficient for introduction into the patient and steering from its point of insertion to a particular desired location within the right atrium of the heart. There is a length. Connected to the distal end of the first region of this guide introducer is the second region, which consists of a bend that curves to the left, as shown in Figure 14A. The angle of this curvature is about 45-55 °, preferably about 50 °. The radius of this curve is about 0.50 to 2.00 inches (1.27 to 5.08 cm), preferably about 1.00 to 2.00 inches (2.54 to 5.08 cm). The total length of this bend is approximately 0.20 to 2.00 inches (0.51 to 5.08 cm)
, Preferably about 0.50 to 1.00 inches (1.13 to 2.54 cm). The third region of the guide introducer is connected to the far end of the second region. As shown in FIG. 14A, the third region comprises a substantially straight portion that is oriented at an angle of about 40 to 60 ° from the direction of the first region, and its total length is about 0.50 to 3.00 inches.
(1.27 to 7.62 cm).

The left atrial cutting track (shown as track 8 in FIG. 2) formed simultaneously with the right atrial cutting track 8 starts from the fossa ovalis and extends upward to the septal lid portion. It is formed so as to be connected to the track 1 shown. This track is also shown as track 8 in FIG. The lead introducer used to form this track in the left atrium is shown in Figures 17A, 17B and 17C.

The first guiding introducer for the left atrium is also the first,
It consists of the second and third regions. The first region of this guide introducer is a normal, generally straight, elongated hollow guide introducer region that is sufficient for introduction into the patient and steering from its point of insertion to a particular desired location within the left atrium of the heart. There is a length. The second region is connected to the distal end of the first region of the first shape-provided induction introducer, and the second region is composed of a curved portion and a straight portion. The bending portion is bent to the left when arranged in the position shown in FIG. 17A. The interior angle of this curve is about 60-80 °, more preferably about 65-75 °. The radius of this bend is approximately 0.30 to 0.70 inches (0.76 to 1.78 inches).
cm), preferably about 0.40 to 0.60 inches (1.02 to 1.52 cm)
It is. The ends of the curve are straight and have a length of about 0.40 to 1.00 inches (1.02 to 2.54 cm), preferably about 0.40 to 0.85 inches (1.02 to 2.16 cm). This first
The third region of the shape-provided induction introducer is connected to the far end of the straight portion of the second region. This third region also includes a curved portion and a straight portion. The bend is at an angle of about 80-100 °, preferably about 85-95 ° and about 0.20-0.40 inches rearward relative to the first region at the position shown in FIG. 17A, as shown in FIGS. 17B and 17C. (0.51 to 1.02 cm), preferably with a radius of about 0.25 to 0.35 inch (0.64 to 0.89 cm). The end of this curve is the last straight section, which is about 0.25 to 0.65 inches (0.64 to 1.65 cm),
It is preferably about 0.40 to 0.50 inches (1.02 to 1.27 cm) with the end of this section being the tip of the induction introducer.

As another guide introducer for forming the track 8 in the left atrium, Japanese Patent Application No. 5-354368 filed by the present applicant is used.
The one shown in FIG. 3 of the issue may be used. This induction introducer is composed of three regions, a first, a second and a third.
See Figures 18A and 18B. The first region is a conventional, generally straight, elongate hollow guide introducer region that is long enough to be introduced into the patient and maneuvered from its point of insertion to a particular desired location within the left atrium of the heart. This sheath is connected to the distal end of the first region of the guide introducer, the second region. The second region is curved so as to draw a first longitudinal curve and curve upward, and at the same time, draw a compound curve that curves to the left and curve second longitudinal curve. The radius of curvature of the first longitudinal curve is approximately 0.50 to 2.00 inches (1.27
~ 5.08 cm), preferably about 0.50 to 1.50 inches (1.27 to 3.8
1 cm). The angle of the arc of the first longitudinal curve is preferably about 40-60 °, more preferably about 45-55 °. The radius of curvature of the second longitudinal curve of the second region is about 0.50 to 4.00.
Inches (1.27-10.16 cm), preferably about 0.50-2.00 inches (1.27-5.08 cm). The third area of the induction introducer is
A curved portion that draws a third longitudinal curve, and the plane of this third region is upwardly about 40 to 60 °, preferably about 45 to 55 °.
Is substantially the same, and substantially the entire third region is in the same plane (at least within 15 ° from the same plane).
The angle of the arc of the curved portion of the third region curved in the longitudinal direction is about 35 to 55 °, preferably about 40 to 50 °.

The distal end of all guide introducers may be tapered, preferably so, for successful transition to the dilator. This taper is preferably 10 °
Less, more preferably about 4-7 °. Preferably,
One or more radiopaque tip marker bands near the tip (far end) of the guide introducer.
d) may be provided. Further, preferably, 1 or 2 or more, and more preferably 3 or 4 small holes may be provided near the tip of the guide introducer. The small hole is preferably within about 1.00 cm from the tip of the induction introducer, more preferably from the tip.
Provide at a position of 0.10 to 1.00 cm. The size of the small holes should be about 40-60 mils in diameter (1 mil = 1/1000 inch = 0.0254 mm).

In general, these small holes cause air embolism to enter into the guide introducer if the distal end of the guide introducer is occluded by withdrawing the catheter inserted into the guide introducer. This is to prevent it. For example, when the tip of the guide introducer is positioned so as to hit the myocardium, if the catheter inserted in the guide introducer is pulled out, decompression will occur in the catheter if no small hole is provided. There is. In such a depressurized state, air may flow back into the guide introducer due to reinsertion of the catheter into the guide introducer tube. Such air embolisms can cause serious problems to the patient, including stroke, potential heart attack and other problems commonly found in intracardiac air embolisms. The addition of a small hole near the tip of the guide introducer allows the fluid (probably blood) to be drawn into the guide introducer tube when the catheter is withdrawn from the guide introducer, preventing the above decompression. This eliminates the possibility of air embolism occurring within the guide introducer.

The guide introducer of the present invention is suitable for use in the human body, which has a shape memory property, that is, it can be deformed to substantially return to a desired three-dimensional, ie, complex, multi-planar shape. It can be made from any suitable material. For purposes of illustration and not limitation, the guide introducer has an inner diameter in the range of about 6-10 French (1 French = 1/3 mm). Such a guide introducer can accommodate a dilator of about 6-10 French and a suitable guide wire. When larger or smaller diameter dilators or catheters are used in combination with the guided introducer of the present invention, it should be understood that the guided introducer of the present invention can be modified in size and shape.

Although it is within the scope of the invention to use the guided introducer of the present invention in varying sizes and shapes for use in pediatric use, the preferred application is for the adult heart. As is well known, for pediatric use, it is necessary to reduce the size of each area of the guide introducer, especially the first area, but no significant change in the shape or curvature of the guide introducer.

It is also within the scope of the present invention to vary the size and shape of the introducer introducer of the present invention for use in special situations, such as are sometimes found in patients with hypertrophied or rotated hearts.

A second lead introducer for the right atrium is shown in FIGS. 15A and 15B. This induction introducer is disclosed in Japanese Patent Application No.
-354368 is the same as the shaped guide introducer shown in FIG. This guide introducer cuts the tissue isthmus that separates the tricuspid valve and the inferior vena cava. See track 5 in FIG. 1 and FIG. Completion of this disconnection prevents the formation of reintroduction circuits around the tricuspid valve and the superior and inferior vena cava.

The second guiding introducer for the right atrium is also divided into three regions. The first region is a conventional, generally straight, elongate hollow guide introducer region that is long enough for introduction into the patient and steering from its point of insertion to a particular desired location within the right atrium of the heart. Connected to the distal end of the first region of this guide introducer is a second region which, as shown in FIG. 15B, curves upward in a first longitudinal curve and at the same time the second longitudinal curve. It is curved by drawing a compound curve that draws and curves to the left. The radius of curvature of the first longitudinal curve is about 0.50 to 2.00 inches (1.27 to 5.08 cm), preferably about 0.50 to 1.50 inches (1.27 to 3.81 cm). First
The interior angle of the longitudinal curve is preferably about 140-120 °, more preferably about 135-125 °. The radius of curvature of the second longitudinal curve of the second region is about 0.50 to 4.00 inches (1.27 to
10.16 cm), preferably about 0.50-2.00 inches (1.27-5.08)
cm). The angle of the second longitudinal curve is preferably FIG.
To the right, as shown in, about 70-110 °, more preferably about
80 to 100 °. The third region of this induction introducer is the second
Connects to the far end of the area. The third region is the third curved portion, and the plane of the third region forms an angle of about 40 to 60 °, preferably about 45 to 55 ° upward from the plane of the first region. Substantially all are coplanar. See Figures 15A and 15B. The arc of the curve in this third region is about 80 to 10
It has a radius of 0 °, preferably about 85-95 °.

A third cutting track in the right atrium runs along the demarcation ridge around the superior and inferior vena cava. See track 6 of FIG. 1 and FIG. Together with the first track (track 5) of the right atrium in Figure 1, this track also prevents the formation of reintroduction circuits around the superior and inferior vena cava. There is also a preferred shape for the third right atrium guide introducer to form this cutting track. This third guiding introducer for the right atrium is
It is divided into three areas as shown in 16A, 16B and 16C.

The remaining guiding introducers described below are also shown in three views from different viewpoints. In each view, the guide introducer is attached to a valve for connection to a conventional catheter and stopcock. In each such arrangement, the front end of the induction introducer (near end)
The shape of the guide introducer will be described with respect to the position of the guide introducer with respect to the side port tube (side port tubing) fixed in place.

In the first of these three drawings, the side port tube lies approximately in the plane of the straight first region of the guide introducer, but is oriented 90 ° to the left (see FIG. 16A).
. In the second drawing, the side port tube is rotated 90 ° clockwise so that the stop cock and the rest of the side port tube cover a part of the first region of the induction introducer (see FIG. 16B). In the third drawing (eg, FIG. 16C), the side port tube is further rotated 90 ° clockwise and the side port tube is again approximately in the same plane as the first region of the induction introducer,
The side port tube is located on the right side of the figure. See Figure 16C.
To help with the explanation, the same placement of the guide introducer with the side port tube is adopted for the remaining guide introducers.

The first region of the third introducer introducer for the right atrium shown in FIG. 16 is the normal, generally straight, elongated hollow introducer introducer region, which is introduced into the patient and from the point of insertion into the heart. It is long enough to maneuver to a particular desired position in the right atrium. The second region is connected to the distal end of the first region of the third shape-provided induction introducer, and the second region
The area is composed of a curved portion that is curved to the right as shown in FIG. 16B. The interior angle of the bend is about 170-150 °, preferably about 165-150 °. The radius of this bend is about 1.50
2.00 inches (3.81 to 5.08 cm), preferably about 1.65 to 1.85
It is an inch (4.19 to 4.70 cm). A third region begins at the end of the bend and initially has a length of about 1.00.
~ 1.60 inches (2.54-4.06 cm), preferably about 1.25-1.
40 inches (3.18 to 3.56 cm) of a generally straight straight line, ending to the right as shown in Figure 16C (or to the left as shown in Figure 16A) at about 70-110 °, preferably about 80 ~Ten
The curved portion is curved at an internal angle of 0 °. The radius of this bend is about 0.30 to 0.50 inches (0.76 to 1.27 cm), preferably about 0.35 to 0.40 inches (0.89 to 1.02 cm).
The end of this bend is the tip (far end) of the guide introducer. Bending part of this third region (from the beginning of bending to the tip)
Preferably has a total length of about 0.40 to 0.70 inches (1.02 to 1.78c
m), more preferably about 0.50 to 0.60 inches (1.27 to 1.52c
m). The tip of this guide introducer may be tapered for successful transition to the dilator, which is preferred. Further, as described above, a tip marker and a small hole may be provided near the tip of the guide introducer, which is preferable.

Two further cutting tracks are formed in the right atrium. These are shown as tracks 7 and 9 in FIG. The track 7 runs along the wall of the atrial septum intermediate the superior and inferior vena cava. This track helps prevent the formation of reintroduction circuits around the superior and inferior vena cava. The last track 9 extends from the middle part of the superior vena cava near the end of the track formed near the demarcation ridge toward the anterior tip of the right atrial appendage. This track helps prevent the formation of reintroduction circuits around the right atrial appendage. Both of these tracks are
A first right atrial guide introducer for use in forming track 8 as shown in FIGS. 14A and 14B, or FIGS.
It can be formed using any of the third right atrium guide introducers used to form the demarcation crest track 6 shown at 6 in FIG. 1 as shown at 16C. Since these guide introducers have already been described, no further explanation is necessary.

Next, the guide introducer used for the left atrium will be described in detail. The first left atrial guide introducer is for separating the left atrial appendage from the left pulmonary vein. Therefore, this first
Shaped left atrial guide introducer assists the cutting catheter in the formation of a cutting track running from the atrioventricular groove at a point in front of the mitral valve and left pulmonary vein toward the atrial septum . See Track 1 of FIG. 2 and FIG. Complete disconnection of the re-introduction circuit preferably requires disconnection of all four tracks, but mitigation of atrial fibrillation in the left atrium can also be achieved using only this first track. is there.

The first left atrial guide introducer is preferably the same lead introducer used to form the left atrial cutting track 8 (which corresponds to the right atrium track 8) in the atrial septum. It is a thing. Figures 11 and 13 and Figure 17
See A, 17B, 17C.

The second left atrial guide introducer is used to separate the left pulmonary vein from the right pulmonary vein. See Track 2 of FIG. 2 and FIG. The cutting track formed using the second left atrial guide introducer is located slightly parallel to the track formed by the first contoured guide introducer and the cutting catheter. This track runs from the tricuspid valve in the atrioventricular groove to the atrial septum, but between the right and left pulmonary veins. The shape of the second guide introducer is similar to that of the first guide introducer.

This second left atrial guide introducer is also divided into three regions. FIG. 19 is a three-view drawing of the second induction introducer.
Referring to A, 19B, 19C, the first region is the normal, generally straight, elongated hollow guide introducer region, which is introduced into the patient and from its point of insertion to a particular desired location within the left atrium of the heart. It is long enough for maneuvering. The second region is connected to the far end of the first region of the second shape-provided induction introducer, and the second region is composed of a curved portion and a straight portion. The bending portion is bent leftward and downward when arranged in the position shown in FIG. 19A. The interior angle of the bend is about 40-80 °, more preferably about 50-70 °. The radius of this bend is about 0.30 to 0.50 inches (0.76 to 1.27 cm), preferably about 0.35 to 0.40 inches (0.89 to 1.02 cm).
The end of this curved part is a straight part, and its length is about
0.50 to 1.00 inches (1.27 to 2.54 cm), preferably about 0.70
~ 0.80 inches (1.78-2.03 cm). The third region of the second shape-provided induction introducer is connected to the far end of the straight portion of the second region. This third region also includes a curved portion and a straight portion. The curved portion is rearward with respect to the first region when arranged in the position shown in FIG. 19A, and FIG.
When it is placed in the position shown in Figure 3, it is curved to the left, and the angle of this curve is about 80 to 100 °, preferably about 85 to 95 °,
The radius is about 0.25 to 0.40 inches (0.64 to 1.02 cm), preferably about 0.30 to 0.40 inches (0.76 to 1.02 cm). The end of this curve is a short straight section with a length of about 0.30.
~ 0.70 inches (0.762-1.778 cm), preferably about 0.40-0.
It is 60 inches (1.02-1.52 cm) and the end of this part is the tip of the induction introducer. As with the first introducer, the tip of the second contoured introducer may also be tapered for successful transition to the dilator, and is preferred. Further, as described above, a tip marker and a small hole may be provided near the tip of the guide introducer.

Next, FIGS. 20A, 20 and 20C are views of the third left atrial guide introducer from three directions. This third left atrial guide introducer takes a significantly different shape than the two left atrial guide introducers previously described. This guide introducer is specifically for completing the separation of the lower left pulmonary vein and surrounding tissue from the rest of the left atrium. Track 3 in Figure 2
See also FIG. This assists in forming a cutting track running from a point above and lateral to the left lower pulmonary vein to pass between the left pulmonary veins. The cutting track intersects the track formed by the cutting catheter with the first and second left atrial guide introducers.

The third left atrial guide introducer also comprises the first, second and third regions. See Figures 20A, 20B, and 20C. The first region of this third left atrial guide introducer is the normal, generally straight, elongated hollow guide introducer region, which is introduced from the patient and its point of insertion to a particular desired location within the left atrium of the heart. Long enough to maneuver. Connected to the distal end of the first region of the guide introducer is the second region, which is composed of a curved portion and a straight portion that draw a compound curve. As shown in FIG. 20A, the curved portion formed by the compound curve of the second region is curved by drawing a first curve to the left with respect to the straight first region, and at the same time, is curved rearward with respect to the first region.
(Or at the position shown in FIG. 20B, it is curved to the right) drawing a second curve. The radius of curvature of the first curve is about 0.40 to 0.60 inches (1.02 to 1.52 cm), preferably about 0.45 to 0.55 inches.
(1.14 to 1.40 cm). The interior angle of the first curve is preferably about 155-115 °, more preferably about 140-120 °. The radius of curvature of the second curve of this second region is about 0.15 to 0.
45 inches (0.381 to 1.143 cm), preferably about 0.20 to 0.30 inches (0.51 to 0.76 cm). The interior angle of this second curve is preferably about 120-160 °, more preferably about 130-150 °.
°. The straight part of the second region of the third induction introducer is
Starting at the end of this compound curve, the length is about 1.20 to 1.50 inches (3.05 to 3.81 cm), preferably about 1.
30 to 1.50 inches (3.30 to 3.81 cm). A third region starts from the end of the straight line portion, and the third region also includes a curved portion and a straight line portion. The bend is curved at an interior angle of about 155-115 °, preferably about 140-120 ° with a radius of about 0.40-0.60 inches (1.02-1.52 cm), as shown in FIG. 20A.
It is. This curved portion is in the same plane as the straight portion of the second region. The end of the curved portion is a straight portion, and this straight portion serves as the tip of the guide introducer. The straight portion of this third region is relatively short and preferably has a length of about 0.20-0.40 inches.
(0.51 to 1.02 cm). Again, it is preferable to taper the transition to the dilator. Also, like other induction introducers, a radiopaque tip marker band and preferably a small hole may be provided near the tip.

The fourth left atrial guide introducer is for separating the right lower pulmonary vein from the right upper pulmonary vein, particularly in the left atrium. This assists in the formation of a cutting track that runs from the posterior point of the atrial septum forward through the upper right pulmonary vein and the lower right pulmonary vein, the formed track being the second cutting track described above. Cross. See track 4 of FIG. 2 and FIG.

The shape of the fourth guiding introducer for the left atrium is different from the above-mentioned three guiding introducers for the left atrium, but it is also composed of the first, second and third regions. Figure 11 seen from three sides
See A, 11B, 11C. The first region of this fourth left atrial guide introducer is the normal, generally straight, elongated hollow guide introducer region, which is introduced into the patient and maneuvered from its point of insertion to a particular desired position within the left atrium. And there is enough length.
Connected to the far end of the first area is the second area, which is composed of a curved portion and a straight portion that draw a compound curve. The curved portion of the second region composed of the compound curve is shown in FIG.
1st to the left with respect to the straight 1st area
Draw a curve and bend at the same time from the first area to the rear
(Or to the right at the position shown in FIG. 21B) is curved with a second curve. The interior angle of the first curve is about 155-105 °, preferably about 140-120 ° and the radius of curvature is about 0.25-0.
It is 50 inches (0.64 to 1.27 cm), preferably about 0.30 to 0.40 inches (0.76 to 1.02 cm). The second curve has an interior angle of about 1
55-125 °, preferably about 150-130 °, with a radius of curvature of about 0.30-0.70 inches (0.76-1.78 cm), preferably about 0.40-0.60 inches (1.02-1.52 cm). At the end of the complex curve part of this second curve is the straight part of the second region of the fourth induction introducer. The length of this straight part is about 1.00-2.
It is 00 inches (2.54 to 5.08 cm), preferably about 1.20 to 1.50 inches (3.05 to 3.81 cm). A third region begins at the end of this straight portion, and this third region consists of a curved portion that ends in the tip of the guide introducer. This curved third region is
As shown in FIG. 21A, about 40-80 °, preferably about 50-70.
Interior angle of ° and approximately 0.30 to 0.50 inches (0.76 to 1.27 cm),
It preferably has a radius of about 0.35 to 0.40 inches (0.89 to 1.02 cm) and is curved to the left in an arc from the plane of the first region. Similar to the first, second and third left atrial guide introducers, a radiopaque tip marker band and preferably a small hole may be provided near the tip of the fourth left atrial guide introducer. Good.

The combined effect of these four cutting tracks and the cutting track along the atrial septum is to divide the left atrium into five compartments that are not in direct electrical communication with each other. Specifically, a small compartment around the lower left pulmonary vein is isolated from the rest of the left atrium. However, any of the remaining compartments can undergo electrical activity or contraction controlled by the predominant sinus rate. The number of cutting procedures can be increased or decreased based on the experimental data and the sensing operation.

The preferred procedure for the left atrium creates five amputated tracks, although extra tracks may be needed, especially if the heart is enlarged. Or,
A smaller number of amputations may be needed in some cases, depending on the needs of the patient.

A left atrial amputation procedure alone may be sufficient to reduce the symptoms of atrial arrhythmia. In that case, amputation of the right atrium may not be necessary. However, for effective amputation of atrial fibrillation, amputation procedures may also be performed in the right atrium.

During surgery, a modified Seldinger technique is usually employed to insert a guide introducer and a cutting catheter into the body. With this method, a small skin incision is made at an appropriate location for easy passage of the catheter or dilator. Subcutaneous tissue is then dissected and the vessel is perforated with a suitable needle having a stylet positioned at a relatively shallow angle. The needle is then incompletely withdrawn and reinserted into the vessel at some different angle to ensure that the needle remains within the vessel.
The flexible tip of an appropriately sized guide wire is then inserted through the needle and into the blood vessel until the tip is just past the needle. Remove the needle while holding the guide wire firmly in place. A guide wire is then advanced through the blood vessel, into the right femoral vein, through the inferior vena cava, and into the right atrium. (The preferred procedure is to approach the left and right atria from below. Retrograde and upper approaches to the left atrium and top approach to the right atrium can also be employed, although in harmony with such alternative approaches. The guide introducer needs to be modified so that the guide wire is held in place while the dilator is passed around the wire and the first guide introducer used is placed around the dilator. To place. The dilator and this guide introducer generally form an assembly that, together, advances along a guide wire,
Place in the inferior vena cava. After inserting this assembly, pull out the guide wire.

The first guide introducer for the right atrium is advanced around the guide wire to perform the cutting and mapping procedure within the right atrium. The purpose of the right atrial cutting track is to prevent the formation of reintroduction circuits around the superior and inferior vena cava and the tricuspid valve,
At the same time, it is to isolate the right atrial appendage. In a preferred procedure, the right atrial cutting track is first formed before the left atrial cutting track is formed. See FIG. Although the cutting order of the tracks in the right atrium is not critical, the preferred cutting order for the tracks shown in FIG. 1 is tracks 5, 6, 7,
The order is 9, 8. For complete cutting of the truck,
It may be necessary to make multiple cuts along a track. A sensing catheter can also be used in the right atrium to confirm that a complete amputation has been made. After confirming the proper amputation, the last right atrial guide introducer is removed to complete the treatment of atrial arrhythmia in the right atrium.

After the treatment of the right atrium is completed, the last guiding introducer for the right side is taken out, and a Brockenbrow needle or trocar (trocar) is inserted through the dilator tube to the right atrium, preferably the fossa ovalis. Used to form an opening in the atrial septum. (This procedure is done to insert a guide introducer into the left atrium.) The atrial septal penetration creates a track (Fig. 1, track 8) parallel to the left atrium within the right atrium. It is preferably done before the treatment of the right atrium is completed so that a cutting track (FIG. 2, track 8) in the atrium can be created. The entire device (dilator and Brockenbrough needle) is delivered through the vena cava into the right atrium, with the tip abutting the atrial septum at the level of the fossa ovalis. The Brockenbrow needle is then advanced inside the dilator to reach the fossa ovalis. After making an opening in the atrial septum, the needle, dilator and first lead introducer for the left atrium are advanced into the left atrium. After advancing the first guide introducer for the left atrium through the atrial septum into the left atrium, the Brockenbrough needle and the dilator are removed, and the first guide introducer remains in the left atrium.
The cutting catheter is then advanced through a tube inside the guide introducer and placed in position within the left atrium which forms a track due to the unique shape of the first guide introducer.
The choice of guiding introducer to use depends on the treatment procedure used by the physician. For each preferred track, several cuts may be required to effectively cut the entire track. The preferred procedure uses four cutting guide introducers, one in sequence (FIGS. 2 and 3, 4,
5 and 6), and tracks 1, 2, 3, and 4 are sequentially formed. It goes without saying that the doctor can change the order of use of the guiding introducer.

When disconnecting the cutting source from the cutting catheter and connecting the catheter to the sensing device, a separate electrophysiology sensing catheter with one or more shaped guide introducers is used: Position within the left atrium may be sensed or mapped to determine whether a suitable cutting track has been created. As already mentioned, the procedure in the left atrium aims to divide the left atrium into five independent compartments that do not directly communicate with each other but with the SA node. In addition, the procedure also aims to isolate the tissue surrounding the left lower pulmonary vein from all remaining tissue in the left atrium. This procedure will create an independent pathway or corridor that prevents or limits the formation of reintroduction circuits in the left atrium. The specific track position may change depending on the condition of the individual heart,
The general procedure described above is the preferred procedure for achieving the desired result for the left atrium.

[0084]

According to the present invention, a desired induction introducer can be installed in X
By selecting in combination with fluoroscopy, the distal portion of the appropriate guide introducer can be steered to move the distal end of the mapping and / or cutting catheter inserted into the guide introducer into the left atrium or right. It can be directed to a specific inner surface within the atrium. In addition, the distal end of the guide introducer is placed at the distal end of the endocardium by providing sufficient rigidity and support that the guide introducer is held in place by the various anatomy of the heart and blood vessel surfaces. It can be held in a fixed or surface position, which allows for proper cutting. The exact placement of the tip of this cutting catheter is important. This is because the constant movement of the tip of the cutting catheter does not dilute the supplied energy by dissipating unfocused energy into the circulating blood by dissipating the unfocused energy throughout the heart chamber. As a result, the amount of energy supplied during the cutting procedure can be significantly reduced. Moreover, the time required to perform the procedure is significantly reduced compared to procedures that do not use a guided introducer. Also, this amputation procedure is similar to those previously achieved in surgical applications such as the use of surgical procedures such as the "Maze" method, corridor method,
It is also possible to achieve the destruction of individual cutting tracks.

Although specific embodiments of the present invention have been illustrated and described above, it will be apparent from the above description that various modifications can be made within the scope of the present invention. In addition,
The embodiments of the present invention are listed below.

(1) A method for treating atrial arrhythmia in the human atrium, wherein a guide introducer having a lumen penetrating from one end to the other end and having a predetermined curved shape is introduced into the atrium. , A cutting and / or mapping catheter is inserted into the guide introducer, the guide introducer is used to guide the catheter to a selected area in the atrium, and the catheter is used to guide the selected area in the atrium. A method of treatment, characterized by performing a mapping and / or a cutting, consisting of a cutting and / or a mapping procedure.

(2) The method according to 1, wherein the region selected for cutting is in the left atrium. (3) The method according to 1, wherein the region selected for cutting is in the right atrium. (4) The method according to 1, wherein the regions selected for cutting are in the left atrium and the right atrium.

(5) The method according to 1, wherein the region selected for amputation comprises a plurality of tracks in the left atrium. (6) The method of 1, wherein the area selected for amputation comprises multiple tracks in the right atrium. (7) The method of 1, wherein the region selected for amputation comprises multiple tracks in the left atrium and the right atrium. (8) The method according to 2, wherein the left atrial appendage is separated from the pulmonary vein.

(9) The method according to 5, wherein the following results are obtained by cutting a plurality of tracks. (a) Left atrial appendage separated from pulmonary vein, (b) left pulmonary vein separated from right pulmonary vein, (c) lower left pulmonary vein separated from upper left pulmonary vein, (d)
The lower right pulmonary vein is separated from the upper right pulmonary vein.

(10) The region selected for amputation in the right atrium includes multiple tracks located around the superior vena cava to the inferior vena cava and between the inferior vena cava and the tricuspid valve. 6. The method according to 6.

(11) A method for treating atrial fibrillation in the human atrium, wherein a guide introducer having a lumen extending from one end to the other end and having a predetermined curved shape is introduced into the left atrium. Then, a cutting and / or mapping catheter is inserted into the guide introducer, the guide introducer is used to guide the catheter to a selected area in the left atrium, and the catheter is used to select the catheter in the left atrium. A treatment method, which comprises performing a cutting treatment consisting of cutting the region.

(12) The method according to 11, wherein the region selected for cutting in the left atrium includes one or more tracks. (13) The method of 12, wherein the region selected for amputation in the left atrium separates the left atrial appendage from the pulmonary vein.

(14) The cutting track produces the following results 12
The described method. (a) Left atrial appendage separated from pulmonary vein, (b) left pulmonary vein separated from right pulmonary vein, (c) lower left pulmonary vein separated from upper left pulmonary vein, (d)
The lower right pulmonary vein is separated from the upper right pulmonary vein.

(15) The method according to 1, wherein the amputation treatment is combined with a medication treatment in order to assist the treatment of atrial arrhythmia. (16) The method according to 1, wherein one of direct current, high frequency, microwave, ultrasonic wave, laser, and fulgtronization is used as a cutting energy source in the cutting treatment. (17) The method according to 16, wherein the cutting treatment is performed using high frequency energy.

(18) To assist in the treatment of atrial arrhythmias,
2. The method according to 1, wherein one or more unbent guide introducers and one or more guide shapes provided with a curved shape are used in combination with a cutting catheter.

(19) The method according to 2, wherein 5 guide introducers are used for the treatment of amputation of the left atrium. (20) The method according to 9, wherein 5 guide introducers are used for the treatment of amputation of the left atrium. (21) The method according to 1, wherein the tip of the induction introducer is tapered. (22) The method according to 1, wherein the guide introducer has one or more small holes near its tip.

(23) A method for treating atrial arrhythmia, which comprises using a cutting and / or mapping procedure including the following steps (a) to (h).

(A) A guide introducer for the right atrium having a lumen penetrating from one end to the other end and having a curved shape is introduced into the right atrium of a human, and (b) this guide introduction for the right atrium is introduced. Position the catheter for mapping and / or cutting in the right atrium with a device so that part of it projects from the tip of the lumen of the guide introducer, and (c) this catheter for cutting and / or mapping. And using the guide introducer for the right atrium,
Step (a), (b) by mapping and / or cutting a predetermined track in the right atrium, and (d) using a right atrial guide introducer provided with the same or another curved shape as described above if necessary.
Repeating (c) and cutting and / or mapping one or more selected tracks in the right atrium,
(e) A guiding introducer for the left atrium, which has a lumen penetrating from one end to the other end and is provided with a curved shape, is introduced into the human left atrium, and (f) this guiding introducer for the left atrium is used. Position the cutting and / or mapping catheter in the left atrium such that a portion thereof projects from the tip of the lumen of the guide introducer, and (g) the cutting and / or mapping catheter and the left atrium. And / or cutting a predetermined track in the left atrium using a guide introducer for use in the left atrium, and (h) using a guide introducer for the left atrium provided with the same or another curved shape as described above, if necessary. Repeating (e), (f) and (g) to cut and / or map one or more selected tracks into the left atrium, thereby
It forms a generally uninterrupted path of electrical impulses from the sinoatrial node to the atrioventricular node, while allowing atrial contraction and enhanced atrioventricular entrainment mediated by the SA node.

(24) The method according to 23, wherein a predetermined track in the left atrium isolates the left atrial appendage from the pulmonary vein. (25) The method according to 23, wherein a predetermined track in the left atrium produces the following result. (a) Left atrial appendage separated from pulmonary vein, (b) left pulmonary vein separated from right pulmonary vein, (c) lower left pulmonary vein separated from upper left pulmonary vein, (d)
The lower right pulmonary vein is separated from the upper right pulmonary vein. (26) The method according to 25, wherein an adjacent region around the lower left pulmonary vein is separated from the rest of the left atrium.

(27) A left atrial amputation and / or mapping procedure creates four independent tracks that divide the left atrium into five distinct compartments, the first track in front of the left pulmonary vein. From the atrioventricular groove at the point to the atrial septum,
The track extends from the atrial septum to the atrioventricular groove through the left and right pulmonary veins, and the third transection track intersects the second track from a point above and to the left of the lower pulmonary vein and between the left pulmonary veins. And the fourth track crosses the second track from the posterior portion of the atrial septum forward through the upper and lower right pulmonary veins,
23. The method of claim 23.

(28) The method according to 23, wherein a cutting track of the right atrium is formed around the superior vena cava to the inferior vena cava and between the inferior vena cava and the tricuspid valve. (29) The cutting track of the right atrium is the first track along the demarcation ridge around the superior and inferior vena cava, the second track toward the tissue separating the tricuspid valve from the inferior vena cava, and the superior vena cava and inferior vena cava. 24. A third track along the atrial septum between.

(30) The method according to 29, wherein a fourth track is formed forward from the middle portion of the superior vena cava to the tip of the right atrial appendage at the apex of the track along the demarcation ridge.

(31) Form a fifth track that is thought to extend upward from the fossa ovalis to the septal lid along the atrial septum.
27. The method of claim 27. (32) The method according to 30, wherein the fifth track is formed so as to extend upward from the fossa ovalis to the septal lid along the atrial septum.

(33) A guide introducer for use in a human heart, which comprises first, second, and third regions from the front side, and the first region is a substantially straight elongated hollow guide introducer section. , The second region connected to the distal end of the first region is a curved portion, connected to the distal end of the curved second region, and the third region located at the tip of the guiding introducer is substantially straight. An induction introducer composed of a straight portion and a curved portion.

(34) The interior angle of the curved second region is about 170 to 15
At 0 °, the radius of that angle is approximately 1.50-2.00 inches (3.81-
The induction introducer according to 33, which is 5.08 cm). (35) The length of the straight part in the third area is approximately 1.00 to 1.60 inches (2.5
4 ~ 4.064 cm), the inner angle of the curved part of the third region is about 70 ~ 110
°, radius is about 0.30 to 0.50 inches (0.762 to 1.27 cm), and the total length of the third region is about 0.40 to 0.70 inches (1.016 to 1.77 cm).
33. The induction introducer according to 33, which is 8 cm).

(36) A guide introducer for use in the human heart, comprising first, second and third regions from the front side, the first region being a substantially straight elongated hollow guide introducer section. The second region connected to the distal end of the first region is composed of a curved portion and a straight portion, and the third region connected to the distal end of the second region and located at the tip of the guiding introducer is , A guide introducer comprising a second curved portion and a third straight portion.

(37) The curved portion of the second region has an internal angle of about 60 to 80 °.
And the radius is approximately 0.30 to 0.70 inches (0.762 to 1.778 cm), and the straight portion of the second region has a length of approximately 0.50 to 1.00 inches (1.2
7 to 2.54 cm), and the angle of the curved portion of the third region is about 80 to
100 °, radius approximately 0.20-0.40 inches (0.508-1.016 cm)
The length of the straight part of the third area is about 0.25 to 0.60 inches (0.6
35. The induction introducer according to 36, which is 35 to 1.524 cm). (38) The inner angle of the curved portion of the second region is about 50 to 70 °, and the radius is about
0.30 ~ 0.50 inch (0.762 ~ 1.27 cm), the length of the straight part is about 0.50 ~ 1.00 inch (1.27 ~ 2.54 cm),
The curved portion of the area has an angle of about 80 to 100 ° and a radius of about 0.25 to 0.
36. The induction introducer according to 36, which is 40 inches (0.635 to 1.016 cm) and the straight portion of the third region has a length of about 0.30 to 0.70 inches (0.762 to 1.778 cm).

(39) The curved portion of the second area is curved to the left with respect to the first area as the first curve, and at the same time is curved to form a compound curve that is curved rearward with respect to the first area as the second curve. The first curve of this compound curve has a radius of about 0.40-
0.60 inches (1.016-1.524 cm), interior angle is about 155-115 °, the second curve of the composite curve has a radius of about 0.15-0.45 inches (0.381-1.143 cm) and an angle of about 120-160 °. ,
The straight portion of the second area is approximately 1.20 to 1.50 inches (3.048 to 3.50 inches) long.
81 cm), and the curved portion of the third region has an angle of about 155-115.
°, radius is about 0.40 to 0.60 inches (1.016 to 1.524 cm), and the length of the straight part of the third region is about 0.20 to 0.40 inches (0.5
The induction introducer according to 36, which is 08 to 1.016 cm).

(40) A guide introducer used for a human heart, comprising first, second, and third regions from the front side, and the first region is a substantially straight elongated hollow guide introducer section. The second region connected to the distal end of the first region is composed of a curved portion and a straight portion, and the third region connected to the distal end of the second region and located at the tip of the guiding introducer is , An induction introducer comprising a second bend.

(41) The curved portion of the second area is curved to the left with respect to the first area as a first curve, and at the same time is curved to form a compound curve that is curved backward to the first area as a second curve. The first curve of this compound curve has an interior angle of about 155 ~
105 ° and a radius of about 0.25 to 0.50 inches (0.635 to 1.27 cm), and the second curve of the composite curve has an interior angle of about 155 to 125.
°, radius is about 0.30 to 0.70 inches (0.762 to 1.778 cm), and the straight part of the second area is about 1.00 to 2.00 inches (2.5
4 to 5.08 cm), and the third region is curved by drawing an arc to the left of the plane of the first region, and the internal angle of the arc is about 40 to 80
° with a radius of approximately 0.30 to 0.50 inches (0.762 to 1.27 cm)
40 Induction introducer.

[Brief description of the drawings]

FIG. 1 is a detailed illustration of the right atrium showing a suitable cutting track.

FIG. 2 is a detailed illustration of the left atrium showing a suitable cutting track.

FIG. 3 is a schematic illustration of the left atrium showing formation of a track 1 using the first left atrial guide introducer shown in FIGS. 17A, B, and C.

FIG. 4 is a schematic illustration of the left atrium showing the formation of the track 2 using the second left atrial lead introducer shown in FIGS. 19A, B, and C.

FIG. 5 is a schematic illustration of the left atrium showing formation of the track 3 using the third left atrial guide introducer shown in FIGS. 20A, 20B and 20C.

FIG. 6 is a schematic illustration of the left atrium showing the formation of the track 4 using the fourth left atrial guide introducer shown in FIGS. 21A, B, and C.

FIG. 7 is a schematic illustration of the right atrium showing formation of a track 5 using the first right atrium guide introducer shown in FIGS. 15A and 15B.

FIG. 8 is a schematic illustration of the right atrium showing formation of the track 6 using the second right atrium guide introducer shown in FIGS. 16A, B, and C.

FIG. 9 shows the formation of track 7 with the third right atrial guide introducer shown in FIGS. 14A, B, or with the second right atrial guide introducer shown in FIGS. 16A, B, C. It is a schematic explanatory drawing of the right atrium.

FIG. 10 shows the formation of track 9 with the third right atrial guide introducer shown in FIGS. 14A, B, or with the second right atrial guide introducer shown in FIGS. 16A, B, C. It is a schematic explanatory drawing of the right atrium.

FIG. 11 shows the right atrium as shown in FIGS. 14A and B and the left atrium as FIGS. 17A, B, C or FIG.
FIG. 2 is a schematic illustration of the atrial septum showing the use of a guided introducer to simultaneously cut the left and right atria as shown in FIGS. is there.

FIG. 12 is a schematic illustration of the right atrium showing the formation of tracks 8 in the right atrium using the guide introducer shown in FIGS. 14A and 14B.

13 shows a left atrium with any of the lead introducers used in FIG. 11 in the left atrium, as shown in FIGS. 17A, B, C, or with the lead introducer shown in FIGS. 18A, B. FIG. 6 is a schematic illustration of the left atrium showing the formation of the inner track 8.

14A is a first direction view of a first right atrial guide introducer used to form tracks 7 and 8 in the right atrium in FIGS. 9, 11, and 12. FIG. is there. The guide introducer is provided with a side port tube mounted at its proximal end, just to the left of the guide introducer in the drawing, and generally flush therewith. FIG. 14B is a view of the first right atrium guide introducer seen from a second direction in which the first right atrium guide is rotated 90 ° clockwise from the position of FIG. 14A, and the side port tube is the first right atrium guide. Located overlying a portion of the first region of the introducer.

15A is a first right atrial guide introducer used to form track 5 as shown in FIG.
It is the figure seen from the direction. The guide introducer is provided with a side port tube mounted at its front end, just to the left of the guide introducer in the drawing, and substantially flush with it. FIG. 15B is a view of the second right atrium guiding introducer shown in FIG. 15A as seen from a second direction rotated 90 ° clockwise from the position of FIG. 15A, in which the side port tube is the second Overlying and overlying a portion of the first region of the right atrial guide introducer.

16A is a first direction view of a third right atrial lead introducer used to form tracks 6, 7, 9 as shown in FIGS. 8, 9, 10. FIG. is there. The guide introducer is provided with a side port tube mounted at its front end, just to the left of the guide introducer in the drawing, and substantially flush with it. FIG. 16B is a view of the third right atrium guiding introducer shown in FIG. 16A as seen from a second direction rotated clockwise by 90 ° from the position of FIG. 16A,
A side port tube overlies a portion of the first region of the third right atrial guide introducer. 16C is the same as FIG.
FIG. 16B is a view of the third right atrium guide introducer shown in FIG. 6A as seen from a third direction rotated 180 ° from the position of FIG. 16A, with the side port tube immediately to the right of the guide introducer and It is located on almost the same plane.

FIG. 17A is a first left atrial guide introducer used to form Track 1 and Track 8 in the left atrium as shown in FIGS. 3, 11, and 13 as viewed from a first direction. It is a figure. The guide introducer is provided with a side port tube mounted at its front end, just to the left of the guide introducer in the drawing, and substantially flush with it. FIG.
17B is a view of the first left atrial guide introducer as seen from the second direction rotated 90 ° counterclockwise from the position of FIG. 17A, in which the guide introducer overlaps the side port tube. ing. FIG. 17C shows the first left atrium guide introducer,
FIG. 17D is a perspective view seen from a third direction rotated 180 ° from the position of FIG. 17B, with the side port tube overlying a portion of the first left atrial guide introducer.

FIG. 18A is used to form a track 8 in the left atrium as shown in FIGS. 11 and 13, FIGS.
It is the figure which looked at the guide introducer for left atrium different from what was shown to 7B and 17C from the 1st direction. The guide introducer is provided with a side port tube mounted at its front end, just to the left of the guide introducer in the drawing, and substantially flush with it. 18B is a view of the left atrial guide introducer shown in FIG. 18A as viewed from a second direction rotated 90 ° clockwise from the position of FIG. 18A, in which the side port tube is the left atrial guide introducer. Overlying a portion of the first region of.

FIG. 19A is a first left atrial lead introducer used to form track 2 as shown in FIG.
It is the figure seen from the direction. The guide introducer is provided with a side port tube mounted at its front end, just to the left of the guide introducer in the drawing, and substantially flush with it. FIG. 19B shows the second left atrium guide introducer,
Second rotated 90 ° counterclockwise from the position of FIG. 19A
FIG. 6 is a view from the direction, with the guide introducer overlying the side port tube. FIG. 19C is a perspective view of the second left atrial guide introducer as seen from a third direction rotated 180 ° from the position of FIG. 19B, and is attached to the front end of the guide introducer. A side port tube overlies a portion of the second left atrial guide introducer.

20A is a first left atrial guide introducer used to form a track 3 as shown in FIG.
It is the figure seen from the direction. The guide introducer is provided with a side port tube mounted at its front end, just to the left of the guide introducer in the drawing, and substantially flush with it. FIG. 20B shows the third left atrial guide introducer,
Second rotated 90 ° counterclockwise from the position of FIG. 20A
FIG. 6 is a view as seen from the direction in which the side port tube is located behind the first region of the third left atrial guide introducer. FIG.
0C is a view of the third left atrial guide introducer as seen from a third direction rotated by 180 ° from the position of FIG. 20A, in which the side port tube is located immediately to the right of the guide introducer,
The straight portion of the third induction introducer is approximately in the same plane.

FIG. 21A is a first left atrial guide introducer used to form track 4 as shown in FIG.
It is the figure seen from the direction. The guide introducer is provided with a side port tube mounted at its front end, just to the left of the guide introducer in the drawing, and substantially flush with it. FIG. 21B shows the fourth left atrial guiding introducer,
Second rotated 90 ° counterclockwise from the position of FIG. 21A
FIG. 7 is a view as seen from the direction in which the side port tube is located behind the first region of the fourth left atrial guide introducer. FIG.
1C is a view of the fourth left atrial guide introducer as seen from a fourth direction rotated 180 ° from the position of FIG. 21A, in which the side port tube is located on the right side of the guide introducer, and
The straight portion of the induction introducer of is substantially in the same plane.

[Explanation of symbols]

SVC: Superior vena cava IVC: Inferior vena cava FO: Fossa ovalis CSos: Coronary sinus opening (OSTIUM OF THE CORONARY SIN)
US) TV: Tricuspid valve (RACU) RAA: Right atrial appendage (RIGHT ATRIAL APPENDAGE) RSPV: Right upper pulmonary vein (RIGHT SUPERIOR PULMONARY VEIN) LSPV: LEFT SUPERIOR PULMONARY VEIN RIPV: Right lower pulmonary vein (RIGHT) INFERIOR PULMONARY VEIN LIPV: LEFT INFERIOR PULMONARY VEIN LAA: LEFT ATRIAL APPENDAGE MV: MITRAL VALVE LFO: Oval ovale (LINBUS of FO)

Claims (41)

[Claims] 1. A method for treating atrial arrhythmia in a human atrium, which comprises introducing a guide introducer having a lumen penetrating from one end to the other end and imparting a predetermined curved shape into the atrium, A cutting and / or mapping catheter is inserted into the guide introducer, the guide introducer is used to guide the catheter to a selected region of the atrium, and the catheter is used to map the selected region of the atrium. Alternatively, a treatment method comprising performing a cutting and / or a mapping treatment. 2. The method of claim 1, wherein the area selected for amputation is in the left atrium. 3. The method of claim 1, wherein the area selected for amputation is in the right atrium. 4. The method of claim 1, wherein the regions selected for amputation are in the left and right atrium. 5. The method of claim 1, wherein the region selected for amputation comprises a plurality of tracks in the left atrium. 6. The method of claim 1, wherein the region selected for amputation comprises a plurality of tracks in the right atrium. 7. The region selected for amputation comprises a plurality of tracks in the left atrium and the right atrium.
The described method. 8. The method of claim 2, wherein the left atrial appendage is separated from the pulmonary vein. 9. The method of claim 5, wherein cutting multiple tracks produces the following results. (a) left atrial appendage separated from pulmonary vein, (b) left pulmonary vein separated from right pulmonary vein, (c) left lower pulmonary vein separated from upper left pulmonary vein, (d) lower right pulmonary vein separated from upper right pulmonary vein. . 10. The region selected for amputation in the right atrium includes a plurality of tracks located around the superior vena cava to the inferior vena cava and between the inferior vena cava and the tricuspid valve. Item 6. The method according to Item 6. 11. A method for treating atrial fibrillation in an atrium of a human being, wherein a guide introducer having a lumen penetrating from one end to the other end and having a predetermined curved shape is introduced into the left atrium. , Inserting a cutting and / or mapping catheter into the guide introducer, using the guide introducer to guide the catheter to a selected area in the left atrium, and using the catheter to select the catheter in the left atrium A treatment method comprising performing a cutting treatment consisting of cutting an area. 12. The region selected for amputation in the left atrium includes one or more tracks.
11. The method according to 11. 13. The method of claim 12, wherein the region selected for transection within the left atrium separates the left atrial appendage from the pulmonary vein. 14. The method of claim 12, wherein the cutting track produces the following results. (a) left atrial appendage separated from pulmonary vein, (b) left pulmonary vein separated from right pulmonary vein, (c) left lower pulmonary vein separated from upper left pulmonary vein, (d) lower right pulmonary vein separated from upper right pulmonary vein. . 15. The method of claim 1, wherein said amputation treatment is combined with medication treatment to aid in the treatment of atrial arrhythmia. 16. The method of claim 1, wherein the cutting procedure utilizes one of direct current, radio frequency, microwave, ultrasonic, laser, and fulgtronization as a cutting energy source. 17. The method of claim 16, wherein the cutting procedure is performed using radio frequency energy. 18. To assist in the treatment of atrial arrhythmia,
The method of claim 1, wherein one or more non-bent guiding introducers and one or more guiding shapes imparting one or more curved shapes are used in combination with the cutting catheter. 19. The method of claim 2, wherein five lead introducers are utilized for the left atrial amputation procedure. 20. The method of claim 9, wherein five lead introducers are utilized for the left atrial amputation procedure. 21. The method of claim 1, wherein the tip of the induction introducer is tapered. 22. The method of claim 1 wherein the guide introducer has one or more small holes near its tip. 23. A method for treating atrial arrhythmia, characterized by using a cutting and / or mapping procedure comprising the steps (a) to (h) below. (a) a guide introducer for the right atrium, which has a lumen penetrating from one end to the other end and is provided with a curved shape, is introduced into the right atrium of a human, (b) using this guide introducer for the right atrium And position the mapping and / or cutting catheter in the right atrium such that a portion thereof projects from the tip of the lumen of the guiding introducer, and (c) the cutting and / or mapping catheter and the right atrium. And / or cutting a predetermined track in the right atrium using a guide introducer for use in the right atrium, and (d) using a guide introducer for the right atrium provided with the same or another curved shape as described above, if necessary. (a), (b) and
Repeating (c), cutting and / or mapping one or more selected tracks in the right atrium, and (e) having a lumen extending from one end to the other and imparting a curved shape. A guide introducer for the left atrium is introduced into the left atrium of a human, and (f) a catheter for cutting and / or mapping in the left atrium is partially introduced by using the guide introducer for the left atrium. Positioned so that it projects from the tip of the lumen of the ventricle, and (g) uses this cutting and / or mapping catheter and the left atrial guide introducer to map and / or cut a given track in the left atrium. , (H) If necessary, using the left atrial guide introducer with the same or different curved shape as the above, steps (e), (f) and
Repeat (g) to cut and / or map one or more selected tracks into the left atrium, thereby allowing SA node-mediated atrial contraction and enhanced atrioventricular entrainment. While forming a generally uninterrupted pathway of electrical impulses from the sinus node to the atrioventricular node. 24. The method of claim 23, wherein a predetermined track in the left atrium isolates the left atrial appendage from the pulmonary vein. 25. The method of claim 23, wherein a predetermined track in the left atrium produces the following results. (a) left atrial appendage separated from pulmonary vein, (b) left pulmonary vein separated from right pulmonary vein, (c) left lower pulmonary vein separated from upper left pulmonary vein, (d) lower right pulmonary vein separated from upper right pulmonary vein. . 26. The method of claim 25, wherein an adjacent region around the left lower pulmonary vein is separated from the rest of the left atrium. 27. A left atrial amputation and / or mapping procedure forms four independent tracks adapted to divide the left atrium into five distinct compartments, the first track being a point anterior to the left pulmonary vein. From the atrioventricular groove of the atrial septum to the second
The track extends from the atrial septum to the atrioventricular groove through the left and right pulmonary veins, and the third transection track intersects the second track from a point above and to the left of the lower pulmonary vein and between the left pulmonary veins. And the fourth track crosses the second track from the posterior portion of the atrial septum forward through the upper and lower right pulmonary veins,
24. The method of claim 23. 28. The method of claim 23, wherein a cutting track in the right atrium is formed around the superior vena cava to the inferior vena cava and between the inferior vena cava and the tricuspid valve. 29. The cutting track of the right atrium is a first track along the demarcation ridge around the superior and inferior vena cava, a second track towards the tissue separating the tricuspid valve from the inferior vena cava, and the superior and inferior vena cava. 24. The method of claim 23, comprising a third track along the atrial septum between the vena cava. 30. The method of claim 29, wherein a fourth track is formed from the middle of the superior vena cava anteriorly to the tip of the right atrial appendage at the apex of the track along the demarcation ridge. 31. The method of claim 27, wherein a fifth track is formed extending from the fossa ovalis to the septal lid upward along the atrial septum. 32. The method of claim 30, wherein a fifth track is formed extending from the fossa ovalis to the septal lid upward along the atrial septum. 33. A guide introducer for use in a human heart, comprising first, second, and third regions from the front side, the first region being a substantially straight elongated hollow guide introducer portion, The second region connected to the distal end of the first region is a curved portion, connected to the distal end of the curved second region, and the third region located at the tip of the guiding introducer is a substantially straight line. Guide introducer consisting of a curved part and a curved part. 34. The interior angle of the curved second region is about 170-15.
At 0 °, the radius of that angle is approximately 1.50-2.00 inches (3.81-
The induction introducer according to claim 33, which is 5.08 cm. 35. The length of the straight portion of the third region is about 1.00 to 1.
At 60 inches (2.54 to 4.06 cm), the interior angle of the bend in the third region is about 70 to 110 degrees and the radius is about 0.30 to 0.50 inches (0.76 to 1.26 cm).
7 cm) and the total length of the third area is approximately 0.40 to 0.70 inches
34. The induction introducer of claim 33, which is (1.02-1.78 cm). 36. A guide introducer for use in a human heart, comprising first, second, and third regions from the near side, the first region being a substantially straight elongated hollow guide introducer portion, The second region connected to the distal end of the first region is composed of a curved portion and a straight part, and the third region connected to the distal end of the second region and located at the tip of the guide introducer is: A guiding introducer including a second bending portion and a third straight portion. 37. The curved portion of the second region has an internal angle of about 60 to 80 °.
And the radius is about 0.30 to 0.70 inches (0.76 to 1.78 cm) and the straight portion of the second region is about 0.50 to 1.00 inches (1.
27 to 2.54 cm), and the angle of the curved portion of the third region is about 80 to
100 °, radius approximately 0.20 to 0.40 inches (0.51 to 1.02 cm)
The length of the straight part of the third area is about 0.25 to 0.60 inches (0.
36-1.52 cm). 38. The interior angle of the curved portion of the second region is about 50 to 70 °.
With a radius of about 0.30 to 0.50 inches (0.76 to 1.27 cm) and a straight length of about 0.50 to 1.00 inches (1.27 to 2.54 cm)
And the curved portion of the third region has an angle of about 80 to 100 ° and a radius of about 0.25 to 0.40 inches (0.64 to 1.02 cm), and the straight portion of the third region has a length of about 0.30 to 0.70 inches (0.76). 37. The induction introducer according to claim 36, wherein 39. The curved portion of the second region is curved so as to curve to the left with respect to the first region as a first curve, and at the same time, to be curved so as to draw a compound curve that is curved to the rear of the first region as a second curve. The first curve of this compound curve has a radius of about 0.40-
0.60 inches (1.02 to 1.52 cm) with an interior angle of about 155 to 115 °, the second curve of the compound curve has a radius of about 0.15 to 0.45 inches (0.38 to 1.14 cm) and an angle of about 120 to 160 °. ,
The straight portion of the second area is approximately 1.20 to 1.50 inches (1.02 to 1.50 inches) long.
52 cm), and the curved portion of the third region has an angle of about 155-115.
°, radius is about 0.40-0.60 inches (1.02-1.52 cm), and the straight part of the third region is about 0.20-0.40 inches (0.
37. The induction introducer according to claim 36, which is 51 to 1.02 cm). 40. A guide introducer for use in a human heart, comprising first, second and third regions from the near side, the first region being a substantially straight elongated hollow guide introducer part, The second region connected to the distal end of the first region is composed of a curved portion and a straight part, and the third region connected to the distal end of the second region and located at the tip of the guide introducer is: An induction introducer including a second bending portion. 41. The curved portion of the second region curves as a first curve to the left of the first region and at the same time as a second curve to curve in a compound curve curved rearward of the first region. The first curve of this composite curve has an interior angle of about 155-
105 ° with a radius of about 0.25 to 0.50 inches (0.64 to 1.27 cm), and the second curve of the composite curve has an interior angle of about 155 to 125.
°, radius is about 0.30 to 0.70 inches (0.76 to 1.78 cm), and the straight portion of the second region is about 1.00 to 2.00 inches (2.
54 to 5.08 cm), and the third region is curved by drawing an arc to the left of the plane of the first region, and the internal angle of the arc is about 40 to 80
41. The induction introducer of claim 40, having a radius of about 0.30 to 0.50 inches (0.76 to 1.27 cm).