JP2004275786A - Non-surgical mapping for atrial arrhythmia and shaped guiding introducer for medical treatment - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a guiding introducer for introducing a catheter to a specific location when atrial arrhythmia is treated through ablation and/or mapping procedures. <P>SOLUTION: The shaped guiding introducer is provided with a pre-determined curvature corresponding to every pre-determined ablation track to be formed within an atrium of a human heart and comprises a first area being a nearly straight and long section from the front side. a second area containing a curved section (sometimes a composite curve may be formed) which is merged to the leading end of the first area and a third area containing a curve which is merged to the leading end of the second area. In the method of treating atrial arrhythmia in the atrium of the human heart, a plurality of such shaped guiding introducers are used for performing ablation and/or mapping procedures. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a method for mapping and treating atrial arrhythmia using a catheter guided by a shaped guiding introducer. The present invention further relates to the preferred shape of the guiding introducer for use with a mapping or ablation catheter for mapping or treating atrial arrhythmias.

  Introducers and catheters have been used for medical procedures for many years. For example, one of its uses is to deliver electrical stimuli to specific sites inside the human body. Another application is to monitor and measure for diagnostic tests in the body. That is, catheters can reach internal sites (eg, the heart) that would otherwise be inaccessible without more invasive procedures (eg, incisions). It can be placed at a specific site in the body that is difficult to access, and can be used for examination, diagnosis and treatment with a catheter. In use, the catheter may be inserted into a major vein or artery near the body surface. Thereafter, 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.

  The utility of catheters in remote and hard-to-reach sites in the body is increasing. 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 precise positioning described above due to the inherent structure of the catheter. The body of a conventional catheter is a long tubular body. For adequate control of catheter movement, the structure must have some rigidity. On the other hand, the catheter must not be so stiff as to prevent bending of the catheter necessary to move the catheter through a vein, artery, or other body part to reach a desired specific site. Further, the catheter must not be so stiff as to injure arteries or veins during movement in the body.

  While it is important that the catheter not be stiff enough to harm the blood vessel, it should provide sufficient stiffness for torque (rotational force) control, that is, the ability to transmit torsional forces along the length of the catheter. It is also important that the catheter is provided. Sufficient torque control allows for controlled steering of the catheter by transmitting the torsional force on the proximal (front) end of the catheter along the catheter to its distal end. The need for greater torque control often conflicts with the need for reduced stiffness to prevent vessel damage.

  Catheters are increasingly being used in medical procedures involving the human heart. In such procedures, a catheter is generally reached through a vein or artery to the heart and is located at a particular site in the heart. Typically, a catheter is inserted into an artery or vein in the patient's leg, neck, upper chest, or arm, and is often guided and passed through various arteries or veins using a guidewire or introducer. , Is advanced until the tip of the catheter reaches the desired site in the heart.

  The distal end of the catheter used for such a procedure may be previously curved to a desired curve shape. By 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, U.S. Pat. No. 4,882,777 discloses a catheter having a complex curved distal end for use in certain procedures in the right ventricle of a person. 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 are disclosed in U.S. Pat. No. 4,883,058 discloses a catheter for use in selective coronary angiography of the right coronary artery. See also U.S. Pat. No. 4,033,031.

  U.S. Pat. No. 5,269,326 discloses a method for transvenous access to the pericardial space through the right atrium for a particular medical procedure. U.S. Pat. No. 4,898,591 discloses a catheter having an inner layer and an outer layer (with a woven portion). U.S. Pat. No. 4,898,591 also discloses a number of different curved shapes for intravascular catheters. See also U.S. Patent Nos. 5,231,994, 4,838,879, 5,171,232 and 5,290,229.

  Atrial fibrillation is the most common sustained arrhythmia. It has been estimated that nearly 0.4% of the adult population and perhaps 10% of the population over the age of 60 have occurred. See Cox, J.L. et al., Electrophysiology, Pacing and Arrhythmia, "Operations for Atrial Fibrillation", Clin. Cardiol., 14, 827-834 (1991).

  Atrial arrhythmias can be either transient or permanent. Many atrial arrhythmias occur in persons with another form of underlying heart disease, but some atrial arrhythmias occur independently. While atrial arrhythmias are less directly linked to death than ventricular arrhythmias, they increase the risk factors for many other diseases, such as stroke, thrombosis, atherosclerosis, systemic and cerebral embolism. , Causing even more medical problems.

In treating atrial fibrillation, antiarrhythmic drugs may provide symptomatic relief. Antiarrhythmic drugs are disclosed, for example, in U.S. Pat. Nos. 4,558,155, 4,500,529, 4,988,698, 5,286,866 and 5,215,989. The treatment of atrial arrhythmias by medication has been disclosed in many medical articles and books, including, for example: Martin, D., et al., Atrial Fibrillation,
pp. 35-41 (1994); Falk, RH, et al., Atrial Fibrillation (1992); Singer, I., et al., Clinical Manual of Electorophysiology (1993). ); And Horowitz, LN, Modern Arrhythmia Management (Current
Management of Arrhythmias) (1991).

  Another treatment for atrial arrhythmia or atrial fibrillation is the use of an implantable atrial defibrillator, or cardioversion. See, for example, U.S. Patent Nos. 5,282,836, 5,271,392 and 5,209,229. See also Martin, D., et al., Atrial Fibrillation, pp. 42-59 (1994).

However, some patients with symptomatic or life-threatening atrial arrhythmias cannot be adequately treated with drugs or medical devices such as those described above. In that case, other forms of aggressive treatment, including surgery, will be required. For example, a surgical procedure for the treatment of atrial arrhythmias called the Maze method has been described in Cox, JL et.
al., Electrophysiology, Pacing and Arrhythmia, Treatment of Atrial Fibrillation, Clin. Cardiol., 14, 827-834 (1991). Cox, JL et al., `` The Surgical Treatment of Atrial Fibrillation '' The Journal of Thoracic and Cardiovascular Surgery, Vol. 101, No. 4, pp. 584-592, 569-583 ( Cox, JL et al., "Surgical Treatment of Atrial Fibrillation," The Journal of Thoracic and Cardiovascular Surgery, Vol. 101, No. 3, pp. 406-426 (March 1991). Can also be referenced. Other surgical procedures for atrial arrhythmias are disclosed, for example, in Martin, D., et al., Atrial Fibrillation, pp. 54-56 (1994).

  Another treatment that has been used for some 10-15 years for certain types of arrhythmias that are not atrial cells, ie, non-atrial arrhythmias, is catheter ablation. This procedure has been used to interrupt or alter the transmission pathways associated with ventricular arrhythmias in the heart. The specific site to be cut will depend on the type of underlying ventricular arrhythmia.

One common amputation procedure is for the treatment of atrioventricular (AV) nodal recess tachycardia. This problem has led to acceptable treatments where disconnecting the fast or slow AV nodal pathway. Singer, I., et al., `` Catheter Ablation for Arrhythmias '' Electrophysiology Clinical Manual (1993); Falk, RH, et al., Atrial Fibrillation 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 (1994). The use of a cutting catheter for a cutting location inside the heart is disclosed, for example, in U.S. Patent Nos. 4,641,649, 5,263,493, 5,231,995, 5,228,442 and 5,281,217. However, none of these discloses using a guiding introducer to guide a cutting catheter to a specific position.

  The source of energy used for catheter cutting is not constant. Initially, the use of high voltage direct current (DC) cutting methods was common. However, in view of the problems associated with the use of direct current, radio frequency (R.F.) cutting has become the preferred source of energy for cutting methods. The use of high frequency energy for cutting is disclosed, for example, in U.S. Patent Nos. 4,945,912, 5,209,229, 5,281,218, 5,242,441, 5,246,438, 5,281,213 and 5,293,868. ing. Other sources of energy that have been considered for cutting heart tissue include lasers, ultrasound, microwaves, and fulgutronization.

  In order to cut the exact location in the heart, it is necessary to place the cutting catheter at the exact location in the heart. Precise positioning of the cutting catheter is particularly difficult in view of the physiology of the heart, especially since the cutting procedure is generally performed while the heart is beating. Generally, catheter placement is determined by a combination of electrophysiological guidance and fluoroscopy (catheter placement is based on known anatomical features such as coronary sinus, high right atrium and right ventricle). A known portion of the heart marked by placing a radiopaque diagnostic catheter inside or on the surface of the target structure).

While this method has been useful for certain arrhythmias, performing a catheter cut in the atrium to treat atrial fibrillation has never been disclosed. Most recently, catheter ablation procedures for AV nodes or His-Purkinje bundles have been described, for example, in U.S. Pat.No. 4,641,649 and Martin, D., et al., Atrial Fibrillation, p.53.
(1994).

It is an object of the present invention to disclose a method for mapping and treating atrial arrhythmias using a cutting catheter guided to a specific location by a shaped guiding introducer.
Another object of the present invention is to disclose a method of cutting a defined trajectory (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 to provide a shaped guide used in combination with a catheter for atrial mapping and cutting of defined tracks in the left and / or right atrium as a treatment for atrial arrhythmias. Disclose an introducer.

  It is another object of the present invention to provide a specially-shaped guiding introducer for use in electrophysiological procedures for treating atrial arrhythmias.

These and other objects can be achieved by the disclosed method of treating atrial arrhythmias of the present invention and the shaped guiding introducer used in the method.
In one aspect, the invention is a method of treating and / or mapping atrial arrhythmias using a mapping and cutting catheter. This method has a lumen penetrating from one end to the other end, introduces a mapping or cutting catheter inside a shaped guiding introducer, and introduces it into the atrium, and maps or cuts a predetermined position in the atrium. It consists of doing.

In a preferred embodiment of the present invention, a cutting and / or mapping procedure for treating atrial arrhythmia comprises the following steps.
(a) having a lumen penetrating from one end to the other end, introducing a shaped guiding introducer into the right atrium of a person,
(b) positioning the cutting and / or mapping catheter in the right atrium using the shaped guiding introducer such that a portion thereof projects from the distal end of the lumen of the guiding introducer;
(c) cutting and / or mapping a predetermined track in the right atrium using a cutting and / or mapping catheter disposed inside the shaped guiding introducer;
(d) repeating steps (a), (b) and (c) using the same or another shaped guiding introducer as described above to cut and / or map a plurality of predetermined tracks in the right atrium This reduces or eliminates reentry circuits in the right atrium,
(e) having a lumen penetrating from one end to the other end, introducing a shaped guiding introducer into the left atrium of a person,
(f) positioning the cutting and / or mapping catheter in the left atrium using the shaped guide introducer such that a portion thereof projects from the distal end of the lumen of the guide introducer;
(g) cutting and / or mapping a predetermined track in the left atrium using a cutting and / or mapping catheter disposed inside the shaped guiding introducer;
(h) repeating steps (e), (f) and (g) using the same or another shaped guiding introducer as described above to cut and / or map a plurality of predetermined tracks in the left atrium By reducing or eliminating the reintroduction circuit in the left atrium,
This creates a generally uninterrupted path or corridor of electrical impulses from the sinoatrial node to the atrioventricular node, while allowing for some complete atrial contraction and atrioventricular entrainment.

  In another aspect, the present invention discloses a specially-shaped guiding introducer for use with a mapping and / or cutting catheter in mapping and / or treating atrial arrhythmias. Specifically, five shaped guide introducers, each having a different shape, are disclosed for treatment in the left atrium, and four shaped guide introducers are disclosed for treatment in the right atrium. You.

  In accordance with the present invention, by selecting the desired guide introducer in combination with fluoroscopy, the distal portion of the appropriate guide introducer is steered to map and / or insert into the guide introducer tube. Alternatively, the distal end of the cutting catheter can be directed to a particular inner surface in the left or right atrium. In addition, by providing sufficient rigidity and support to hold the guiding introducer in place by the various anatomical structures of the heart and vascular surfaces, the distal end of the guiding introducer can be It can be held in a fixed position or a surface position, so that an appropriate cut can be made. Accurate placement of the cutting catheter tip is important. This is because the constant movement of the tip of the cutting catheter does not cause dilution of the supplied energy due to the loss of unfocused energy throughout the chamber of the heart and loss into the circulating blood. As a result, the amount of energy supplied during the cutting procedure can be significantly reduced. Further, the time required to perform the procedure is significantly reduced as compared to procedures that do not use a guide introducer. The cutting procedure may also achieve the destruction of individual cutting tracks, similar to those previously achieved in surgical applications, for example, using surgical procedures such as the "maze" procedure, corridor procedures, etc. it can.

Although specific embodiments of the present invention have been illustrated and described above, it will be apparent from the above description that various changes may be made within the scope of the present invention.
Examples of the embodiments of the present invention are as follows.

(1) A method for treating atrial arrhythmia in a human atria,
Having a lumen penetrated from one end to the other end, introducing a guide introducer having a predetermined curved shape into the atrium,
Inserting a cutting and / or mapping catheter into the guiding introducer,
Guide the catheter to a selected area within the atrium using this guiding introducer,
Mapping or cutting a selected area in the atrium using a catheter,
Performing a cutting and / or 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 region selected for cutting is in the left atrium and the right atrium.

5. The method of claim 1, wherein the region selected for cutting includes a plurality of tracks in the left atrium.

6. The method of claim 1, wherein the region selected for cutting comprises a plurality of tracks in the right atrium.

7. The method of claim 1, wherein the region selected for cutting includes a plurality of 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 cutting a plurality of tracks produces the following results.
(a) left atrial appendage separated from pulmonary vein,
(b) the left pulmonary vein is separated from the right pulmonary vein,
(c) the lower left pulmonary vein is separated from the upper left pulmonary vein,
(d) Lower right pulmonary vein separated from upper right pulmonary vein.

(10) The region according to (6), wherein the region selected for amputation in the right atrium comprises a plurality of tracks located from the superior vena cava to the inferior vena cava and between the inferior vena cava and the tricuspid valve. Method.

(11) a method of treating atrial fibrillation in a human atria,
Having a lumen penetrating from one end to the other end, introducing a guide introducer having a predetermined curved shape into the left atrium,
Inserting a cutting and / or mapping catheter into the guiding introducer,
Guide the catheter to a selected area in the left atrium using this guiding introducer,
Cutting a selected area in the left atrium using a catheter,
A therapeutic method comprising performing a cutting procedure comprising:

(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 method according to 12, wherein the cutting track produces the following result.
(a) left atrial appendage separated from pulmonary vein,
(b) the left pulmonary vein is separated from the right pulmonary vein,
(c) the lower left pulmonary vein is separated from the upper left pulmonary vein,
(d) Lower right pulmonary vein separated from upper right pulmonary vein.

(15) The method according to (1), wherein a drug treatment is used in combination with the ablation treatment to assist the treatment of atrial arrhythmia.

(16) The method according to (1), wherein one of a direct current, a high frequency wave, a microwave, an ultrasonic wave, a laser, and a fulguronization is used as a cutting energy source in the cutting procedure.

(17) The method according to 16, wherein the cutting treatment is performed using high-frequency energy.

(18) In order to assist treatment of atrial arrhythmia, one or more uncurved guiding introducers and one or more curved guiding introducers are used in combination with a cutting catheter. The method of claim 1.

(19) The method according to (2), wherein five guide introducers are used for a left atrial ablation procedure.

(20) The method according to (9), wherein five guide introducers are used for a left atrium amputation procedure.

(21) The method according to (1), wherein the tip of the guiding introducer is tapered.

(22) The method according to (1), wherein the guiding 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) having a lumen penetrating from one end to the other end, introducing a guide introducer for the right atrium to which a curved shape is imparted into the right atrium of a person,
(b) using the right atrial guiding introducer to position a mapping and / or cutting catheter in the right atrium such that a portion thereof projects from the distal end of the lumen of the guiding introducer;
(c) mapping and / or cutting a predetermined track in the right atrium using the cutting and / or mapping catheter and the right atrial guiding introducer;
(d) If necessary, repeat steps (a), (b) and (c) using a right atrial guiding introducer provided with the same or another curved shape as described above, so that 1 or Cutting and / or mapping two or more selected tracks;
(e) having a lumen penetrating from one end to the other end, introducing a guiding introducer for the left atrium to which a curved shape has been imparted, into the left atrium of a person,
(f) positioning the cutting and / or mapping catheter in the left atrium using the left atrial guide introducer such that a portion thereof projects from the distal end of the lumen of the guide introducer;
(g) mapping and / or cutting a predetermined track in the left atrium using the cutting and / or mapping catheter and the left atrial guiding introducer;
(h) If necessary, steps (e), (f) and (g) are repeated using a left atrial guiding introducer provided with the same or another curved shape as described above, so that 1 or Cutting and / or mapping two or more selected tracks;
Thereby forming a generally uninterrupted path of electrical impulses from the sinoatrial node to the atrioventricular node, while allowing for atrial contraction and enhanced atrioventricular synchronization mediated by the SA node.

(24) The method according to (23), wherein the predetermined track in the left atrium isolates the left atrial appendage from the pulmonary vein.

(25) The method according to (23), wherein the predetermined track in the left atrium produces the following result.
(a) left atrial appendage separated from pulmonary vein,
(b) the left pulmonary vein is separated from the right pulmonary vein,
(c) the lower left pulmonary vein is separated from the upper left pulmonary vein,
(d) Lower right pulmonary vein separated from upper right pulmonary vein.

(26) The method according to 25, wherein the adjacent region around the lower left pulmonary vein is separated from the rest of the left atrium.

(27) The left atrial amputation and / or mapping procedure forms four independent tracks that divide the left atrium into five distinct compartments, with the first track being the chamber at a point in front of the left pulmonary vein. From the ventricular sulcus to the atrial septum, the second track from the atrial septum to the atrioventricular sulcus through between the left and right pulmonary veins, and the third cutting track from the point above and laterally to the lower left pulmonary vein. 24. The method of claim 23, wherein the second track intersects the second track through the veins, and the fourth track crosses the second track anteriorly from the posterior portion of the atrial septum and between the upper and lower right pulmonary veins.

(28) The method according to 23, wherein the cutting track of the right atrium is formed from the superior vena cava to the periphery of the inferior vena cava and between the inferior vena cava and the tricuspid valve.

(29) The right atrial cutting track is the first track along the demarcation ridge around the upper and lower vena cava, the second track is directed to the tissue separating the tricuspid valve from the inferior vena cava, the superior vena cava and the inferior vena cava 23. A third track along the atrial septum between.

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

(31) The method according to (27), wherein the fifth track is formed so as to extend from the fossa ovalis along the atrial septum to the septum lid.

(32) The method according to 30, wherein the fifth track is formed so as to extend from the fossa ovalis along the atrial septum to the septum lid.

(33) A guide introducer used for a human heart, comprising first, second and third regions from the near side, wherein the first region is a substantially straight and elongated hollow guide introducer portion, The second region leading to the distal end of the region is a curve, the third region leading to the distal end of the curved second region, and the third region located at the tip of the guiding introducer is substantially straight and straight. A guiding introducer comprising a curved portion.

(34) The guiding introducer according to (33), wherein the interior angle of the curved second region is about 170 to 150 ° and the radius of the angle is about 1.50 to 2.00 inches (3.81 to 5.08 cm).

(35) The length of the straight section of the third area is about 1.00 to 1.60 inches (2.54 to 4.064 cm), the inner angle of the curved section of the third area is about 70 to 110 °, and the radius is about 0.30 to 0.50 inch (0.762 34. The guide introducer according to claim 33, wherein the third region has a total length of about 0.40 to 0.70 inches (1.016 to 1.778 cm).

(36) A guide introducer used for a human heart, comprising first, second, and third regions from the near side, wherein the first region is a substantially straight and elongated hollow guide introducer portion, A second region connected to the distal end at the end of the region is composed of a curved portion and a straight portion, and a third region connected to the distal end at the end of the second region and located at the tip of the guiding introducer is the second region. And a third linear portion.

(37) The curved portion of the second area has an inner angle of about 60 to 80 ° and a radius of about 0.30 to 0.70 inch (0.762 to 1.778 cm), and the linear portion of the second area has a length of about 0.50 to 1.00 inch. (1.27 to 2.54 cm), the curved part of the third area has an angle of about 80 to 100 °, a radius of about 0.20 to 0.40 inch (0.508 to 1.016 cm), and the straight part of the third area has a length of about 37. The guidance introducer of claim 36, which is 0.25 to 0.60 inches (0.635 to 1.524 cm).

(38) The inner angle of the curved portion of the second area is about 50 to 70 °, the radius is about 0.30 to 0.50 inch (0.762 to 1.27 cm), and the length of the straight section is about 0.50 to 1.00 inch (1.27 to 2.54 inch). cm), the curved portion of the third area has an angle of about 80 to 100 °, a radius of about 0.25 to 0.40 inch (0.635 to 1.016 cm), and the straight portion of the third area has a length of about 0.30 to 0.70 inch. 36. The guiding introducer according to 36, which is (0.762 to 1.778 cm).

(39) The curved portion of the second area is curved as a first curve to the left with respect to the first area and simultaneously as a second curve with a composite curve curved backward to the first area. The first curve of the composite curve has a radius of about 0.40 to 0.60 inches (1.016 to 1.524 cm) and an interior angle of about 155 to 115 °, and the second curve of the composite curve has a radius of about 0.15 to 0.45 inches (0.381 to 0.381 inches). The angle is about 120-160 °, the straight section in the second area is about 1.20-1.50 inches (3.048-3.81 cm) in length, and the curved section in the third area has an angle of about 155- 37. The guide introducer of claim 36, wherein the linear region of the third region has a length of about 0.20 to 0.40 inches (0.508 to 1.016 cm) at 115 ° and a radius of about 0.40 to 0.60 inches (1.016 to 1.524 cm).

(40) A guide introducer used for a human heart, comprising first, second, and third regions from the near side, wherein the first region is a substantially straight and elongated hollow guide introducer unit, A second region connected to the distal end at the end of the region is composed of a curved portion and a straight portion, and a third region connected to the distal end at the end of the second region and located at the tip of the guiding introducer is the second region. Guidance introducer consisting of a curved part.

(41) The curved portion of the second region is curved as a first curve to the left with respect to the first region and simultaneously as a second curve with a composite curve curved backward to the first region. The first curve of the composite curve has an interior angle of about 155 to 105 ° and a radius of about 0.25 to 0.50 inch (0.635 to 1.27 cm), and the second curve of the composite curve has an interior angle of about 155 to 125 ° and a radius of about 155 to 125 °. Is about 0.30 to 0.70 inches (0.762 to 1.778 cm), the straight section of the second area is about 1.00 to 2.00 inches (2.54 to 5.08 cm) in length, and the third area is on the left of the plane of the first area. 41. The guidance introducer of 40, wherein the guide introducer is curved in an arc toward the interior, the interior angle of the arc being about 40-80 degrees, and the radius being about 0.30-0.50 inches (0.762-1.27 cm).

  The normal human heart has a right ventricle, right atrium, left ventricle and left atrium. The right atrium is in fluid communication with the superior and inferior vena cava. The right atrium and right ventricle are separated by the atrioventricular septum. The tricuspid valve contained within the atrioventricular septum provides communication between the right atrium and the right ventricle. There is a thin recessed portion on the inner wall of the right atrium in contact with the left atrium, and this is the oval fossa. FIG. 1 is a detailed explanatory diagram of the right atrium, and FIG. 2 is a detailed explanatory diagram of the left atrium.

  In the fetal heart, the fossa ovale (open ostium) is open so that fetal blood can flow between the right and left atrium. In most people, this opening closes after birth, but in as much as 25 percent of people, the opening (open stoma) remains in place of the fossa ovalis between the right and left atrium. Between the fossa ovalis and the tricuspid valve is an opening or mouth to the coronary sinus. The coronary sinus is a large epicardial vein that contains most of the venous blood drained from the myocardium into the right atrium.

  In a normal heart, the contraction and relaxation of the myocardium (myocardium) occurs regularly, and electrochemical signals are transmitted through the myocardium from the sinoatrial (SA) node to the atrioventricular (AV) node and the His-Parkinje system Consequences flow sequentially to the left and right ventricles along a distinct path, including: The first electrical stimulus occurs in the SA node and is transmitted to the AV node. The AV node is near the opening of the coronary sinus in the atrial septum of the right atrium. The His-Parkinje system begins at the AV node, progresses along the membranous atrial septum toward the tricuspid valve, through the atrioventricular septum and into the membranous ventricular septum. Approximately in the middle of the ventricular septum, the His-Parkinje system branches right and left, straddling the top of the muscles of the ventricular septum.

  An abnormal rhythm, sometimes called atrial arrhythmia, sometimes occurs in the atrium. The three most common types of arrhythmias are ectopic atrial tachycardia, atrial fibrillation, and atrial flutter. Atrial fibrillation can cause significant discomfort to the patient and can even be fatal. The reason is that atrial fibrillation has many attendant problems, including the following (1)-(3). (1) irregular heart rate causes discomfort and anxiety; (2) loss of synchrony of atrioventricular contractions, resulting in instability of the heart's circulation and various levels of congestive heart failure; 3) Suspension of blood circulation (congestion) increases the susceptibility to thromboembolism.

  Although it may be difficult to determine the specific pathological cause of atrial fibrillation, the primary mechanism (cause) is one or more reentry (left) formed in the left and / or right atrium. ) It is considered to be a circuit. Prior attempts to alleviate the above problems have highlighted the use of pharmacological treatments. Pharmacological treatment is sometimes effective, but in some cases drug treatment is ineffective and often suffers from side effects, including dizziness, nausea, visual impairment and other symptoms.

  In recent years, surgical procedures have also been used to treat atrial arrhythmias. The goal of this surgical approach is to reduce the subjective symptoms of atrial arrhythmias and restore normal atrial effects on cardiac output, as in pharmacological treatment, and to normalize hemodynamics , Both. One proposed method requires a surgical procedure to isolate the left atrium from the rest of the heart. See Cox, J.L. et al., "Surgical Treatment of Atrial Fibrillation," Journal of Thoracic and Cardiovascular Surgery, Vol. 101, No. 4, p. 570 (1991).

  The initial incision leaves scar tissue after such an operation, effectively isolating the left atrium and possibly reducing some of the patient's subjective symptoms. Such relief can only occur if the right atrium maintains sufficient sinus rhythm. There are various problems associated with this procedure, including the need to maintain proper sinus rhythm, as well as the risk of thromboembolism.

Another treatment for the treatment of atrial arrhythmias is amputation of the His bundle. Thereafter, a permanent pacemaker is implanted, producing a regular ventricular beat. Cox, JL et
al., "Surgical Treatment of Atrial Fibrillation", Journal of Thoracic and Cardiovascular Surgery, Vol. 101, No. 4, pp. 570-572 (1991). However, atrial fibrillation may still persist, normal cardiac hemodynamics are not restored, and the risk of thromboembolism still remains.

A newer surgical procedure proposed by Guiraudon in 1985 created a narrow corridor between the SA and AV nodes. Guiraudon, GM,
et al., "Combined Sinoatrial Node / Atrial Ventricular Node Isolation: a Surgical Alternative to His Bundle Ablation in Patients with Atrial Fibrillation, Circuration 72: (pt-2) III-220 (1985). This procedure separates the narrow corridor from the rest of the atrial musculature and, in some cases, the number of subunits associated with atrial arrhythmias. Can be alleviated.

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 Surgery, Vol. 101, pp. 569-83
(1991). In this procedure, an atrial incision is made at the appropriate location to interrupt the transmission path in the area within the atrium that produces the most common reintroduction circuit. The procedure is also intended to direct sinus stimulation from the sinus node to the atrioventricular node along a specific path. Also, after the procedure, the entire atrial myocardium (excluding the left and right atrial appendages and pulmonary veins) is electrically activated by providing multiple blind arrays (blind alleys) that deviate from the primary pathway between the SA and AV nodes. It is also intended to preserve the atrial transport function after surgery. Although this procedure has yielded good therapeutic results in some patients, the potential risks are high because of the large area of surgery.

  The effectiveness of the "maze" method is that a certain line, i.e., a track, to prevent the formation of reintroduction circuits, while allowing atrial contractions to still be possible and to return to normal atrioventricular transmission Relies on destroying tissue in the atrium. It has been found that similar success can be achieved without invasive surgery using an intra-atrial ablation procedure. However, in order to perform this cutting procedure, the cutting catheter is positioned at a predetermined position in the left and right atriums, and cuts a predetermined track (line or trajectory) in the left and right atriums, thereby forming a reintroduction circuit. It is necessary to form a natural barrier against It is necessary to form a cutting track at a well-defined position in the left and right atriums, and to form a proper transmural lesion, the electrodes of the cutting catheter and the heart tissue to be cut need to be connected. It is important to maintain sufficient contact pressure in between.

  The cutting catheter used in this cutting procedure produces scar tissue at predetermined locations in the atrium. The energy required to injure or cut tissue can be supplied from many different sources. Initially, direct current was used to obtain energy for the cutting procedure. More recently, radio frequency (R.F.) has become the preferred energy source. Laser, microwave, ultrasonic and fulguronization means have also been used to perform the cutting procedure. The preferred energy source for the cutting process of the present invention is high frequency energy.

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

  Simply introducing a cutting catheter into the left or right atrium without accurate positioning and proper contact pressure will not be able to form the desired cutting track. This precise positioning and proper contact pressure is a special technique that can guide the cutting catheter to the correct position to produce a properly cut track and apply the appropriate pressure to the tip of the cutting catheter. This cannot be achieved without using a guiding introducer with a pre-curved shape.

  Elements of treatment for atrial arrhythmias also include sensing locations within the atria to efficiently and accurately map the atrium. The physiology of the heart and its pulsation also hinder the effectiveness of the mapping catheter. The guiding introducer of the present invention can also assist in accurate placement of such a mapping catheter.

  Physicians often monitor the introduction of a cardiac catheter into the vasculature and its progress within the vessel using fluoroscopy. Unfortunately, fluoroscopy devices generally cannot easily identify specific shapes within the heart, and specifically cannot determine critical structures in the left and right atrium. Therefore, it is extremely difficult to arrange and use the cutting catheter unless a curved guiding 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 guide introducer of the present invention addresses and solves such problems and allows for the precise placement of the catheter necessary for a precise cutting procedure.

  The guiding introducer of the present invention performs the positioning function of automatically positioning the mapping and / or cutting catheter at the exact location required for the procedure as a result of its shape. The guide introducer designed (shaped) into this particular shape is made from a conventional elongated catheter. Although the guide introducer of the present invention has a plurality of sections (regions) as described below, it is manufactured by a conventional method of manufacturing a guide introducer, preferably into a single integrated structure. . In addition to its unique curved shape, the guide introducer of the present invention has a radiopaque tip (tip) marker and outlet as described in more detail below.

  In a 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 two or more guide introducers are combined. They may be used together to form an appropriately shaped guiding introducer. For example, a first shaped guide introducer may be placed inside a second shaped guide introducer, and the combined shape of the first and second guide introducers working together may be a first shape. And depending on the degree of rotation of each of the second guide introducers and the degree of insertion of the inner (first) guide introducer into the interior of the outer (second) guide introducer. May be.

  If a different single guiding introducer is used for each procedure, each guiding introducer is used separately to guide the catheter along an individual track. After holding the cutting catheter at a predetermined position using a guide introducer having a curved shape in advance, a predetermined cutting track is cut using the cutting catheter. Complete cutting of a track may require more than one cutting operation along one track.

  Activity along the track can also be sensed using sensing elements located within the catheter. After the cutting procedure has been completed, the first shaped guiding introducer used is removed, a second shaped guiding introducer is inserted in its place, and the procedure using the cutting catheter is repeated, and the following procedure is performed. Form a cutting track. The above procedure is continued until all of the predetermined cutting tracks in the heart have been completely cut. 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 which track to cut in the left and right atrium is generally determined from the experimental and clinical data previously collected for the patient. For example, Cox, JL et
al., "Surgical Treatment of Atrial Fibrillation", Journal of Thoracic and Cardiovascular Surgery, Vol. 101, pp. 406-426 (1991). However, the adjustment of the position and number of cutting tracks (the number of cutting tracks) is clearly within the discretion of the physician. For example, Scheinman describes `` Catheter-Induced Ablation of the Atrioventricular Junction to Control Refractory Supraventicular Arrhythmias '', JAMA 248: 851 -5 (1982), the cutting track may be selected to completely separate the left atrium. Or, Giraudon, Guiraudon, GM, et al., "Separation of Combined Sinus / Atrioventricular Node: A Surgical Alternative to His Bundle Amputation in Atrial Fibrillation Patients, Circuration 72: (pt-2) III-220 ( As suggested in 1985), the cutting track can be selected to form a "corridor" between the atrial sinus node and the AV node.

  Although the amputation and mapping procedure may begin first with either the left or right atrium, it is preferred that the procedure begin with the right atrium prior to transection of the atrial septum. The transection procedure in the right atrium is specifically designed to prevent or delay the onset of atrial flutter. This also helps in treating other atrial arrhythmias. The cutting track that forms in the right atrium is designed so that reintroduction circuits do not particularly form 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. More or less tracks may be formed, depending on the doctor's choice. The choice of which track to build first is at the discretion of the physician.

  The cutting track in the right atrial septum, shown as track 8, is preferably formed simultaneously with forming the corresponding cutting track in the left atrial septum. See track 8 in FIG. 1, track 8 in FIG. 2, and FIGS. A 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 right atrial track is the track formed by the first guiding introducer for the left atrium (Track 1 in FIG. 2) and the right atrium, reaching the septal roof upward from the ovarian fossa margin. And the track 6 of FIG. This is possible because the left and right atrial tracks are on opposite sides of the atrial septum. These tracks are preferably formed after the remaining right tracks have been formed.

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

  The guiding introducer for forming this track 8 in the right atrium is preferably divided into two parts. Preferably, each part is connected to the other part, forming one continuous guiding introducer, preferably formed in a single fabrication process. See FIGS. 14A-14B and FIGS. 11 and 12. This guide introducer is the same as the guide 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 first, second and third regions. The first region of the guide introducer is a conventional, generally straight, elongated hollow guide introducer region that is sufficient for introduction into the patient and maneuvering from its insertion point to a particular desired location in the right atrium of the heart. There is a length. Connected to the distal end of the first region of the guiding introducer is a second region, which comprises a curved portion that curves to the left, as shown in FIG. 14A. The angle of this curvature is about 45-55 °, preferably about 50 °. The radius of this curvature 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 overall length of this bend is about 0.20-2.00 inches (0.51-5.08 cm), preferably about 0.50-1.00 inches (1.13-2.54 cm). The third region of the guiding introducer is connected to the distal end of the second region. As shown in FIG. 14A, the third region comprises a substantially straight portion oriented at an angle of about 40 to 60 degrees from the direction of the first region, and has a total length of 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), which is formed simultaneously with the right atrial cutting track 8, starts at the margin of the fossa ovalis and proceeds upwards to the septum lid. It is formed so as to be connected to 1. This track is also shown as track 8 in FIG. The guiding introducer used to form this track in the left atrium is shown in FIGS. 17A, 17B and 17C.

  The first guiding introducer for the left atrium also comprises first, second and third regions. The first region of the guide introducer is a conventional, generally straight, elongated hollow guide introducer region that is sufficient for introduction into the patient and maneuvering from the point of insertion to a particular desired location within the left atrium of the heart. Length. A second region is connected to the distal end of the first region of the first shaped guiding introducer, and the second region includes a curved portion and a straight portion. The bending portion is bent to the left when arranged at the position shown in FIG. 17A. The interior angle of this curvature is about 60-80 °, more preferably about 65-75 °. The radius of this curvature is about 0.30 to 0.70 inches (0.76 to 1.78 cm), preferably about 0.40 to 0.60 inches (1.02 to 1.52 cm). The end of this bend is a straight section which is 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). The third region of the first shaped guide introducer is connected to the distal 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 inch 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 inches (0.64 to 0.89 cm). The end of this curve is the last straight section, the length of which is about 0.25-0.65 inches (0.64-1.65 cm), preferably about 0.40-0.50 inches (1.02-1.27 cm), at the end of this section Is the tip of the guiding introducer.

  Another guiding introducer for forming the track 8 in the left atrium may be the one shown in FIG. 3 of Japanese Patent Application No. 5-354368 by the present applicant. This guiding introducer is composed of first, second and third regions. See FIGS. 18A and 18B. The first region is a common, generally elongate, elongated, hollow guide introducer region that is sufficiently long for introduction into the patient and for maneuvering from its insertion point to a particular desired location within the left atrium of the heart. Connected to this sheath, the distal end of the first region of the guiding introducer, is the second region. The second region is curved upward with a first longitudinal curve and simultaneously curved with a composite curve that curves leftward with a second longitudinal curve. 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). 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 to 10.16 cm), preferably about 0.50 to 2.00 inches (1.27 to 5.08 cm). The third region of the guiding introducer is a curved portion that describes a third longitudinal curve, the plane of which is oriented upward at an angle of about 40-60 °, preferably about 45-55 °. The third region is substantially entirely 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 guiding introducers may be, and preferably is, tapered to transition well to the dilator. This taper is preferably less than 10 °, more preferably about 4-7 °. Preferably, one or more radiopaque tip marker bands may be provided near the distal end of the guide introducer. Also, preferably, one or two or more, more preferably three or four small holes may be provided near the distal end of the guiding introducer. The stoma is preferably provided within about 1.00 cm from the tip of the guide introducer, more preferably 0.10-1.00 cm from the tip. The size of the holes is preferably about 40-60 mils in diameter (1 mil = 1/1000 inch = 0.0254 mm).

  Generally, these stomas prevent air embolism caused by withdrawal of a catheter inserted in the guiding introducer from entering the guiding introducer should the distal end of the guiding introducer become blocked. This is to prevent it. For example, if the distal end of the guiding introducer is positioned so as to hit the myocardium, if the catheter inserted in the guiding introducer is pulled out, a decompression state may occur in the catheter if no small hole is provided. There is. Under such reduced pressure, air may flow back into the guide introducer due to reinsertion of the catheter into the tube of the guide introducer. Such air embolism can cause significant problems to the patient, including stroke, possible heart attack, and other problems commonly seen with intracardiac air embolism. The addition of a stoma near the tip of the guide introducer allows the fluid (probably blood) to be drawn into the guide introducer tubing when the catheter is withdrawn from the guide introducer, preventing the decompression described above. This eliminates the possibility of air embolism occurring in the guide introducer.

  The guiding introducer of the present invention is any shape suitable for use in the human body that is shape memoryable, that is, capable of substantially returning to a desired three-dimensional, or complex, multi-planar shape when deformed. It can be manufactured from materials. Illustrating specific dimensions for purposes of illustration and not limitation, the inner diameter of the guide introducer is in the range of about 6 to 10 French (1 French = 1/3 mm). Such a guide introducer can accept a dilator of about 6 to 10 French and a suitable guidewire. If larger or smaller diameter dilators or catheters are used in conjunction with the guide introducer of the present invention, it is understood that the guide introducer of the present invention can be modified in size and shape.

  It is within the scope of the present invention to vary the size and shape of the guide introducer of the present invention and use it in pediatrics, but the preferred use is for the adult heart. As is well known, for pediatrics, the dimensions of each region of the guiding introducer, particularly the first region, need to be reduced, but no significant changes are required in the shape or curvature of the guiding introducer.

It is also within the scope of the present invention to vary the size and shape of the guide introducer of the present invention for use in special situations, such as those sometimes seen in patients with enlarged or rotated hearts.
A second lead introducer for the right atrium is shown in FIGS. 15A and 15B. This guiding introducer is the same as the shaped guiding introducer shown in FIG. 4 of the applicant's Japanese Patent Application No. 5-354368. This guide introducer cuts the tissue isthmus separating the tricuspid valve and the inferior vena cava. See track 5 and FIG. 7 of FIG. Upon completion of this cut, the formation of a reintroduction circuit around the tricuspid valve and the upper and lower vena cava is prevented.

  This second lead introducer for the right atrium is also divided into three regions. The first region is a common, substantially straight, elongated, hollow guide introducer region that is long enough to be introduced into a patient and maneuvered from its insertion point to a particular desired location in the right atrium of the heart. Connected to the distal end of the first region of the guiding introducer is a second region which, as shown in FIG. 15B, curves upwards in a first longitudinal curve and at the same time as the second longitudinal curve. , And curve 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). The interior angle of the first 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 to 2.00 inches (1.27 to 5.08 cm). The angle of the second longitudinal curve is preferably about 70-110 ° to the right, as shown in FIG. 15, and more preferably about 80-100 °. The third region of the guiding introducer leads to the distal end of the second region. The third region is a third curved portion, and the plane of the third region forms an angle of about 40 to 60 °, preferably about 45 to 55 ° above the plane of the first region, and Substantially entirely coplanar. See FIGS. 15A and 15B. The arc of the curve of this third region has a radius of about 80-100 °, 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 and FIG. 8 in FIG. Together with the first track of the right atrium of FIG. 1 (Track 5), this track also prevents the formation of reintroduction circuits around the superior and inferior vena cava. The third right atrial guide introducer for forming this cutting track also has a preferred shape. This third right atrial guide introducer is divided into three regions as shown in FIGS. 16A, 16B and 16C.

  Note that the remaining guiding introducers described below are also shown in three views from different viewpoints. At each point of view, the guide introducer is attached to a conventional catheter and valve for connection to a stopcock. In each of these arrangements, the position of the guide introducer relative to the side port tube (side port tubing) where the front end (proximal end) of the guide introducer is fixed at a predetermined position. The shape of the introducer will be described.

  In the first of these three drawings, the side port tube is located 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 stopcock and the rest of the side port tube cover part of the first region of the guide introducer (see FIG. 16B). In the third drawing (eg, FIG. 16C), the side port tube has been further rotated 90 ° clockwise, and the side port tube is again approximately in the same plane as the first region of the guide introducer, but the side port tube has been rotated. Is located on the right side of the figure. See FIG. 16C. A similar arrangement of guide introducers with side port tubes is used for the rest of the guide introducers to aid in the description.

The first region of the third guiding introducer for the right atrium, shown in FIG. 16, is a common, substantially straight, elongated hollow guiding introducer region, which is inserted from the point of introduction to the patient and into the right atrium of the heart. Is long enough to maneuver to a particular desired position. Connected to the distal end of the first region of the third shaped guiding introducer is a second region, which extends from a curved portion curved rightward as shown in FIG. 16B. Become. The interior angle of this bend is about 170-150 °, preferably about 165-150 °. The radius of this bend is about 1.50 to 2.00 inches (3.81 to 5.08 cm), preferably about 1.65 to 1.85 inches (4.19 to 4.70 cm). Beginning at the end of the bend, a third region begins and is initially about 1.00 to 1.60 inches (2.54 to 4.06 cm) in length, preferably about 1.25 to 1.40 inches.
(3.18-3.56 cm), almost straight, and finally about 70-110 ° to the right as shown in FIG. 16C (or to the left as shown in FIG. 16A), preferably about 80-100 °. It is a curved part that is curved at an inside angle of °. 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 (distal end) of the guide introducer. The total length of the curved portion (from the start of bending to the tip) of this third region is preferably about 0.40 to 0.70 inches (1.02 to 1.78 cm), more preferably about 0.50 to 0.60 inches (1.27 to 1.52 cm). The tip of the guide introducer may be tapered, and is preferred, for a successful transition to the dilator. As described above, a tip marker and a small hole may be provided near the distal end of the guiding introducer, and it is more preferable.

  Two more cutting tracks are formed in the right atrium. These are shown as tracks 7 and 9 in FIG. Track 7 runs along the wall of the atrial septum midway between the superior and inferior vena cava. This track helps prevent the formation of reintroduction circuits around the upper and lower 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 to the tip of the right atrial appendage in a forward direction. This track helps prevent the formation of a reintroduction circuit around the right atrial appendage. Both of these tracks are referred to as the first right atrial guide introducer used to form track 8 as shown in FIGS. 14A and 14B, or as 6 in FIG. 1 as shown in FIGS. 16A, 16B and 16C. It can be formed using any of the third right atrial guide introducers used to form the illustrated demarcation ridge track 6. Since these guiding introducers have already been described, no further explanation is necessary.

Next, the guide introducer used in 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. Thus, this first shaped left atrial guide introducer introduces a cutting catheter in the formation of a cutting track running from the atrioventricular groove at a point anterior to the mitral valve and the left pulmonary vein toward the atrial septum. It is to assist. See track 1 and FIG. 3 of FIG. While complete cutting of the reintroduction circuit preferably requires cutting all four tracks, mitigation of atrial fibrillation in the left atrium can also be achieved using only this first track. is there.

  The first left atrial guiding introducer is preferably the same as the guiding introducer used to form the left atrial cutting track 8 (which corresponds to the right atrial track 8) in the atrial septum. . See FIGS. 11 and 13 and FIGS. 17A, 17B, 17C.

  A second left atrial guide introducer is used to separate the left pulmonary vein from the right pulmonary vein. See track 2 and FIG. 4 of FIG. The cutting track formed using the second left atrial guide introducer lies slightly parallel to the track formed by the first shaped guide introducer and the cutting catheter. The track runs from the tricuspid valve in the atrioventricular sulcus to the atrial septum, but between the right and left pulmonary veins. The shape of the second guiding introducer is similar to the first guiding introducer.

This second left atrial guide introducer is also divided into three regions. Referring to FIGS. 19A, 19B, and 19C, which are three views of the second guiding introducer, the first region is a common, substantially straight, elongated hollow guiding introducer region, which is introduced into the patient and the point of insertion. To a specific desired position within the left atrium of the heart. A second region is connected to the distal end of the first region of the second shaped guide introducer, and the second region includes a curved portion and a straight portion. The curved portion is curved leftward and downward when arranged at the position shown in FIG. 19A. The interior angle of this 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 bend is a straight section and has a length of about 0.50 to 1.00 inches (1.27 to 2.54 cm), preferably about 0.70 to 0.80 inches (1.78 to 2.03 cm). The third region of the second shaped guide introducer is connected to the distal 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 curved rearward with respect to the first region when arranged at the position shown in FIG. 19A, and is curved leftward when arranged at the position shown in FIG. 19B. -100 °, preferably about 85-95 °, with a radius of about 0.25-0.40 inches (0.64-1.02 cm), preferably about 0.30-0.40 inches (0.76-1.02 cm). The end of this curve is a short straight section, its length is about 0.30-0.70 inch (0.762-1.778 cm), preferably about 0.40-0.60 inch
(1.02 to 1.52 cm), and the end of this part is the tip of the guiding introducer. The distal end of this second shaped guide introducer may also be tapered, as with the first guide introducer, to facilitate transition to the dilator, and is preferred. Further, as described above, a tip marker and a small hole may be provided near the distal end of the guide introducer.

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

  The third left atrial guiding introducer also comprises first, second and third regions. See FIGS. 20A, 20B and 20C. The first region of the third left atrial guide introducer is a common, substantially straight, elongated hollow guide introducer region, from the point of introduction to the patient and its insertion to a particular desired location within the left atrium of the heart. Is long enough to maneuver. Connected to the distal end of the first region of the guiding introducer is the second region, which is composed of a curved portion and a straight portion that describe a compound curve. As shown in FIG. 20A, the curved portion composed of the compound curve of the second region curves and draws the first curve to the left with respect to the straight first region, and at the same time, curves backward (or In the position shown in FIG. 20B, it is curved to the right (to the right). 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 in 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 section of the second region of the third guiding introducer starts at the end of the curve describing the compound curve and is about 1.20-1.50 inches (3.05-3.81 cm) in length, preferably about 1.30-1.50 inches. (3.30 to 3.81 cm). A third region starts from the end of the straight portion, and the third region also includes a curved portion and a straight portion. The bend, as shown in FIG. 20A, bends at an interior angle of about 155 to 115 °, preferably about 140 to 120 °, and has a radius of about 0.40 to 0.60 inches (1.02 to 1.52 cm). This curved portion is in the same plane as the straight portion in the second area. The end of the curved portion is a straight portion, and the straight portion is the tip of the guide introducer. The straight section of this third region is relatively short and preferably has a length of about 0.20 to 0.40 inches. Again, it is preferable to taper so that the transition to the dilator is successful. As with other guide introducers, a radiopaque tip marker band and preferably a small hole may be provided near the distal end.

  A fourth left atrial guide introducer is for separating the lower right pulmonary vein from the upper right pulmonary vein, especially in the left atrium. This assists in forming a cutting track running between the posterior point of the atrial septum and anteriorly between the upper right pulmonary vein and the lower right pulmonary vein, wherein the formed track is the same as the second cutting track described above. Intersect. See track 4 and FIG. 6 in FIG.

  The shape of the fourth guiding introducer for the left atrium is different from that of the above-mentioned three guiding introducers for the left atrium, but also comprises the first, second and third regions. See FIGS. 11A, 11B and 11C from three sides. The first region of this fourth left atrial guide introducer is a common, substantially straight, elongated hollow guide introducer region, which introduces the patient and steers it from the point of insertion to a particular desired location in the left atrium. And there is enough length. The second region is connected to the far end of the first region, and is composed of a curved portion that draws a composite curve and a straight line portion. As shown in FIG. 21A, the curved portion of the second region composed of the composite curve curves and draws the first curve to the left with respect to the straight first region, and at the same time, backwards from the first region (or FIG. 21B). (Rightward at the position shown in FIG. 3) and curved in a second curve. The interior angle of the first curve is about 155 to 105 °, preferably about 140 to 120 °, and the radius of curvature is about 0.25 to 0.50 inch (0.64 to 1.27 cm), preferably about 0.30 to 0.40 inch (0.76 to 1.02 cm) It is. The second curve has an interior angle of about 155 to 125 degrees, preferably about 150 to 130 degrees, and a radius of curvature of about 0.30 to 0.70 inches (0.76 to 1.78 cm), preferably about 0.40 to 0.60 inches (1.02 to 1.52 inches). cm). At the end of the compound curve part of this second curve comes the straight part of the second region of the fourth guiding introducer. The length of this straight section is about 1.00 to 2.00 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 the straight section, and the third region consists of a curved portion that ends at the tip of the guide introducer. The curved third region has an interior angle of about 40-80 °, preferably about 50-70 °, and about 0.30-0.50 inch (0.76-1.27 cm), preferably about 0.35-0.40 °, as shown in FIG. 21A. It has a radius of inches (0.89 to 1.02 cm) and curves leftward in an arc from the plane of the first area. Similar to the first, second and third left atrial guide introducers, a radiopaque tip marker band and preferably a small hole may also be provided near the tip of the fourth left atrial guide introducer. Good.

  The combined effect of these four cutting tracks and the cutting tracks along the atrial septum is to divide the left atrium into five compartments that are not directly electrically connected to 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. It is also possible to increase or decrease the number of cutting procedures based on the experimental data and the sensing operation.

  Although the preferred procedure for the left atrium produces five cut tracks, extra tracks may be needed, especially if the heart is enlarged. Alternatively, depending on the needs of the patient, fewer cuts may be required in some cases.

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

  During surgery, a modified Seldinger technique is commonly used to insert the guide introducer and cutting catheter into the body. With this method, a small skin incision is made at an appropriate location through which the catheter or dilator can easily pass. The incision in the subcutaneous tissue is then made, and the vessel is punctured with a suitable needle with a stylet positioned at a relatively shallow angle. The needle is then withdrawn incompletely and reinserted into the vessel at a slightly different angle to ensure that the needle remains within the vessel. The flexible tip of an appropriately sized guidewire is then inserted through the needle into the blood vessel until the tip is slightly ahead of the needle. Remove the needle while holding the guidewire firmly in place. The guidewire is then advanced through the vessel and into the right atrium from the right femoral vein via the inferior vena cava. (A preferred procedure is to approach the left and right atrium from below. A retrograde approach to the left atrium and an approach from above and an approach from above to the right atrium may be employed, but are consistent with such alternative approaches. The dilator is then passed around the wire while the guidewire is held in place, and the first guiding introducer to be used is placed around this dilator. To place. The dilator and this guide introducer generally form an assembly, which together travels along a guidewire and enters the inferior vena cava. After inserting the assembly, the guide wire is pulled out.

  A first guide introducer for the right atrium is advanced around the guidewire to perform a cutting and mapping procedure in the right atrium. The purpose of the right atrial cutting track is to prevent the formation of reintroduction circuits around the upper and lower vena cava and tricuspid valve, while isolating 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. The cutting order of the tracks in the right atrium is not important, but the preferred cutting order for the tracks shown in FIG. 1 is the order of tracks 5, 6, 7, 9, 8. It may be necessary to make multiple cuts along a track for complete cutting of the track. A sensing catheter can also be used in the right atrium to confirm that a complete cut has been made. After confirming that the appropriate amputation has been performed, the last right atrial guide introducer is removed to complete the treatment of atrial arrhythmias in the right atrium.

  After the right atrial procedure has been completed, the last right guiding introducer is removed and a Brockenbrough needle or trocar is inserted through the dilator tube to the right atrium, preferably in the atrial ovaries and into the atrium. Used to form openings in the septum. (This procedure is performed to insert a guide introducer into the left atrium.) Penetration of the atrial septum creates a track (FIG. 1, track 8) parallel to the left atrium in the right atrium, and at the same time the left It is preferably done before the right atrial procedure is completed so that a cutting track (FIG. 2, track 8) in the atrium can be formed. The entire device (dilator and Brockenbrough needle) is delivered from the vena cava into the right atrium, with the tip hitting the atrial septum at the level of the fossa ovalis. The Brockenblow needle is then advanced inside the dilator to reach the fossa ovale. After creating an opening in the atrial septum, the needle, dilator and first lead introducer for the left atrium are advanced into the left atrium. After the left atrial first lead introducer is advanced through the atrial septum into the left atrium, the Brockenbrough needle and dilator are removed, leaving the first lead introducer in the left atrium. The cutting catheter is then advanced through a tube inside the guide introducer and positioned at a location in the left atrium forming a track by the unique shape of the first guide introducer. The choice of guiding introducer to use depends on the procedure used by the physician. For each preferred track, several cuts may be required to effectively cut the entire track. In a preferred procedure, four cutting guide introducers are used one after the other (see FIGS. 2 and 3, 4, 5, 6) to form tracks 1, 2, 3, 4 in sequence. It goes without saying that the order of use of the guiding introducer can be changed by the doctor.

  When disconnecting the cutting source from the cutting catheter and connecting the catheter to the sensing device, use a separate electrophysiology sensing catheter, independent with one or more shaped guiding introducers, to properly cut A position in the left atrium may be sensed or mapped to determine whether a track has been formed. As already mentioned, the procedure in the left atrium is intended to divide the left atrium into five independent compartments that do not directly communicate with each other but communicate with the SA node. Further, the procedure is also aimed at isolating 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. Although the specific track location may vary depending on the condition of the individual heart, the general procedure described above is the preferred procedure to achieve the desired result for the left atrium.

FIG. 2 is a detailed illustration of the right atrium showing a preferred cutting track. FIG. 3 is a detailed illustration of the left atrium showing a preferred cutting track. FIG. 18 is a schematic illustration of the left atrium showing the formation of track 1 using the first left atrial guidance introducer shown in FIGS. 17A, B and C. FIG. 20 is a schematic illustration of the left atrium showing the formation of track 2 using the second left atrial guidance introducer shown in FIGS. 19A, B and C. FIG. 21 is a schematic illustration of the left atrium showing the formation of track 3 using the third left atrial guide introducer shown in FIGS. 20A, 20B and 20C. FIG. 22 is a schematic illustration of the left atrium showing the formation of track 4 using the fourth left atrial guidance introducer shown in FIGS. 21A, B and C. FIG. 16 is a schematic explanatory view of the right atrium showing the formation of a track 5 using the first right atrial guiding introducer shown in FIGS. 15A and 15B. FIG. 17B is a schematic illustration of the right atrium showing the formation of a track 6 using the second right atrial guidance introducer shown in FIGS. 16A, 16B and C. Schematic representation of the right atrium showing the formation of the track 7 using the third right atrial guide introducer shown in FIGS. 14A, B, or using the second right atrial guide introducer shown in FIGS. 16A, B, C. FIG. Schematic representation of the right atrium showing the formation of a track 9 using the third right atrial guide introducer shown in FIGS. 14A, B, or using the second right atrial guide introducer shown in FIGS. 16A, B, C. FIG. As shown in FIGS. 14A and 14B for the right atrium, and for the left atrium, as shown in FIGS. 17A, B and C or FIGS. 18A and 18B, lead introduction for simultaneous cutting of the left and right atriums. FIG. 3 is a schematic illustration of the atrial septum, showing the use of the device to form two parallel tracks, shown as 8. FIG. 15 is a schematic illustration of the right atrium showing the formation of a track 8 in the right atrium using the guiding introducer shown in FIGS. 14A and 14B. As shown in FIGS. 17A, B and C, a track 8 in the left atrium using either the guiding introducer used in FIG. 11 in the left atrium or using the guiding introducer shown in FIGS. 18A and B. FIG. 3 is a schematic explanatory diagram of a left atrium showing formation of a left atrium. FIG. 14A is a view from the first direction of the first right atrial guiding introducer used to form the tracks 7 and 8 in the right atrium in FIGS. The guide introducer has at its front end a side port tube mounted just to the left of the guide introducer in the drawing and approximately flush therewith. FIG. 14B is a view of the first right atrial guiding introducer viewed from a second direction rotated clockwise by 90 ° from the position of FIG. 14A, and the side port tube has the first right atrial guiding. Overlying a portion of the first region of the introducer. FIG. 15A is a view of the second right atrial guiding introducer viewed from the first direction, used to form the track 5 as shown in FIG. The guide introducer has a side port tube mounted at its front end, immediately to the left of the guide introducer in the drawing and substantially flush therewith. FIG. 15B is a view of the second right atrial guiding introducer shown in FIG. 15A viewed from a second direction rotated clockwise by 90 ° from the position of FIG. 15A, and the side port tube is in the second direction. Overlying a portion of the first region of the right atrial guide introducer. FIG. 16A is a view from a first direction of a third right atrial guide introducer used to form tracks 6, 7, 9 as shown in FIGS. The guide introducer has a side port tube mounted at its front end, immediately to the left of the guide introducer in the drawing and substantially flush therewith. FIG. 16B is a view of the third right atrial guiding introducer shown in FIG. 16A viewed from a second direction rotated clockwise by 90 ° from the position of FIG. 16A, and the side port tube is the third port. Overlying a portion of the first region of the right atrial guide introducer. FIG. 16C is a view of the third right atrial guiding introducer shown in FIG. 16A viewed from a third direction rotated 180 ° from the position of FIG. 16A, and the side port tube is located on the right side of the guiding introducer. And substantially in the same plane. FIG. 17A is a view from the first direction of a first left atrial guiding introducer used to form tracks 1 and 8 in the left atrium as shown in FIGS. . The guide introducer has a side port tube mounted at its front end, immediately to the left of the guide introducer in the drawing and substantially flush therewith. FIG. 17B is a view of the first left atrial guiding introducer as seen from a second direction rotated by 90 ° counterclockwise from the position of FIG. 17A, and the guiding introducer is positioned above the side port tube. overlapping. FIG. 17C is a perspective view of the first left atrial guiding introducer as seen from a third direction rotated 180 ° from the position of FIG. 17B, and the side port tube has the first left atrial guiding introducer. On top of some of the. FIG. 18A shows another left atrial guiding introducer, different from that shown in FIGS. 17A, 17B and 17C, used to form a track 8 in the left atrium as shown in FIGS. FIG. The guide introducer has a side port tube mounted at its front end, immediately to the left of the guide introducer in the drawing and substantially flush therewith. 18B is a view of the left atrial guiding introducer shown in FIG. 18A viewed from a second direction rotated 90 ° clockwise from the position of FIG. 18A, and the side port tube has a left atrial guiding introducer. Over a part of the first region. FIG. 19A is a view of the second left atrial guide introducer used in forming the track 2 as shown in FIG. 4 when viewed from the first direction. The guide introducer has a side port tube mounted at its front end, immediately to the left of the guide introducer in the drawing and substantially flush therewith. FIG. 19B is a view of the second left atrial guiding introducer as viewed from a second direction rotated by 90 ° counterclockwise from the position of FIG. 19A, and the guiding introducer is positioned above the side port tube. overlapping. FIG. 19C is a perspective view of the second left atrial guiding introducer rotated from the position of FIG. 19B by 180 ° as viewed in a third direction, and is attached to the front end of the guiding introducer. A side port tube overlies a portion of the second left atrial guide introducer. FIG. 20A is a view of the third left atrial guiding introducer used in forming the track 3 as shown in FIG. 5 when viewed from the first direction. The guide introducer has a side port tube mounted at its front end, immediately to the left of the guide introducer in the drawing and substantially flush therewith. FIG. 20B is a view of the third left atrial guiding introducer as seen from a second direction rotated 90 ° counterclockwise from the position of FIG. 20A, and a side port tube is provided for the third left atrial. It is located behind the first area of the guiding introducer. FIG. 20C is a view of the third left atrial guiding introducer as viewed from a third direction rotated 180 ° from the position of FIG. 20A, and a side port tube is located immediately to the right of the guiding introducer; The straight section of the third guiding introducer is approximately in the same plane. FIG. 21A is a diagram of a fourth left atrial guiding introducer used in forming the track 4 as shown in FIG. 6 as viewed from a first direction. The guide introducer has a side port tube mounted at its front end, immediately to the left of the guide introducer in the drawing and substantially flush therewith. FIG. 21B is a view of the fourth left atrial guiding introducer as viewed from a second direction obtained by rotating the fourth left atrial guiding introducer by 90 ° counterclockwise from the position of FIG. It is located behind the first area of the guiding introducer. FIG. 21C is a view of the fourth left atrial guiding introducer as seen from the fourth direction rotated 180 ° from the position of FIG. 21A, and the side port tube is located on the right side of the guiding introducer, The straight section of the guiding introducer 4 is approximately in the same plane.

Explanation of reference numerals

SVC: superior vena cava (SUPERIOR VENA CAVA)
IVC: Inferior vena cava (INFERIOR VENA CAVA)
FO: Follicular fossa (FOSSA OVALIS)
CSos: Coronary sinus opening (OSTIUM OF THE CORONARY SINUS)
TV: TRICUSPID VALVE
RAA: Right Atrial Appendage (RIGHT ATRIAL APPENDAGE)
RSPV: 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 (LEFT ATRIAL APPENDAGE)
MV: Mitral valve
LFO: LINBUS of FO

Claims (32)

A method of treating atrial arrhythmia in a human atria, comprising:
Having a lumen penetrated from one end to the other end, introducing a guide introducer having a predetermined curved shape into the atrium,
Inserting a cutting and / or mapping catheter into the guiding introducer,
Guide the catheter to a selected area within the atrium using this guiding introducer,
Mapping or cutting a selected area in the atrium using a catheter,
Performing a cutting and / or mapping procedure. The method of claim 1, wherein the region selected for cutting is in the left atrium. The method of claim 1, wherein the region selected for cutting is in the right atrium. The method of claim 1, wherein the regions selected for cutting are in the left atrium and the right atrium. The method of claim 1, wherein the region selected for cutting comprises a plurality of tracks in the left atrium. The method of claim 1, wherein the region selected for cutting comprises a plurality of tracks in the right atrium. The method of claim 1, wherein the region selected for cutting comprises a plurality of tracks in the left atrium and the right atrium. 3. The method of claim 2, wherein the left atrial appendage is separated from the pulmonary vein. 6. The method of claim 5, wherein cutting a plurality of tracks produces the following results.
(a) left atrial appendage separated from pulmonary vein,
(b) the left pulmonary vein is separated from the right pulmonary vein,
(c) the lower left pulmonary vein is separated from the upper left pulmonary vein,
(d) Lower right pulmonary vein separated from upper right pulmonary vein. 7. The method of claim 6, wherein the region selected for amputation in the right atrium includes a plurality of tracks located around the superior to inferior vena cava and between the inferior vena cava and the tricuspid valve. . A method of treating atrial fibrillation in a human atria,
Having a lumen penetrating from one end to the other end, introducing a guide introducer having a predetermined curved shape into the left atrium,
Inserting a cutting and / or mapping catheter into the guiding introducer,
Guide the catheter to a selected area in the left atrium using this guiding introducer,
Cutting a selected area in the left atrium using a catheter,
A therapeutic method comprising performing a cutting procedure comprising: 12. The method of claim 11, wherein the region selected for cutting in the left atrium comprises one or more tracks. 13. The method of claim 12, wherein the region selected for amputation in the left atrium separates the left atrial appendage from the pulmonary vein. 13. The method of claim 12, wherein the cutting track produces the following results.
(a) left atrial appendage separated from pulmonary vein,
(b) the left pulmonary vein is separated from the right pulmonary vein,
(c) the lower left pulmonary vein is separated from the upper left pulmonary vein,
(d) Lower right pulmonary vein separated from upper right pulmonary vein. 2. The method of claim 1, wherein the amputation is combined with a medication to aid in the treatment of atrial arrhythmias. 2. The method of claim 1, wherein the cutting procedure utilizes one of direct current, radio frequency, microwave, ultrasonic, laser, and fulguronization as the energy source for the cutting. 17. The method according to claim 16, wherein the cutting is performed using high-frequency energy.
2. The method of claim 1, wherein one or more non-curved guiding introducers and one or more curved guiding introducers are used in combination with the cutting catheter to assist in the treatment of atrial arrhythmias. The described method. 3. The method of claim 2, wherein five lead introducers are utilized for the left atrial ablation procedure. 10. The method of claim 9, wherein five guide introducers are utilized for the left atrial ablation procedure. The method of claim 1, wherein the tip of the guiding introducer is tapered. The method of claim 1, wherein the guide introducer has one or more stomas near its tip. A method for treating atrial arrhythmia, which comprises using a cutting and / or mapping procedure including the following steps (a) to (h).
(a) having a lumen penetrating from one end to the other end, introducing a guide introducer for the right atrium to which a curved shape is imparted into the right atrium of a person,
(b) using the right atrial guiding introducer to position a mapping and / or cutting catheter in the right atrium such that a portion thereof projects from the distal end of the lumen of the guiding introducer;
(c) mapping and / or cutting a predetermined track in the right atrium using the cutting and / or mapping catheter and the right atrial guiding introducer;
(d) If necessary, repeat steps (a), (b) and (c) using a right atrial guiding introducer provided with the same or another curved shape as described above, so that 1 or Cutting and / or mapping two or more selected tracks;
(e) having a lumen penetrating from one end to the other end, introducing a guiding introducer for the left atrium to which a curved shape has been imparted, into the left atrium of a person,
(f) positioning the cutting and / or mapping catheter in the left atrium using the left atrial guide introducer such that a portion thereof projects from the distal end of the lumen of the guide introducer;
(g) mapping and / or cutting a predetermined track in the left atrium using the cutting and / or mapping catheter and the left atrial guiding introducer;
(h) If necessary, steps (e), (f) and (g) are repeated using a left atrial guiding introducer provided with the same or another curved shape as described above, so that 1 or Cutting and / or mapping two or more selected tracks;
Thereby forming a generally uninterrupted path of electrical impulses from the sinoatrial node to the atrioventricular node, while allowing for atrial contraction and enhanced atrioventricular synchronization mediated by the SA node. 24. The method of claim 23, wherein the predetermined track in the left atrium isolates the left atrial appendage from the pulmonary veins. 24. The method of claim 23, wherein the predetermined track in the left atrium produces the following result.
(a) left atrial appendage separated from pulmonary vein,
(b) the left pulmonary vein is separated from the right pulmonary vein,
(c) the lower left pulmonary vein is separated from the upper left pulmonary vein,
(d) Lower right pulmonary vein separated from upper right pulmonary vein. 26. The method of claim 25, wherein the adjacent area surrounding the lower left pulmonary vein is separated from the rest of the left atrium. The left atrial amputation and / or mapping procedure forms four independent tracks that divide the left atrium into five distinct compartments, the first track from the atrioventricular groove at a point in front of the left pulmonary vein. The second track leads from the atrial septum through the left and right pulmonary veins to the atrioventricular groove, and the third cutting track leads from the point above and to the left lower pulmonary vein to the left pulmonary vein. 24. The method of claim 23, wherein the second track intersects the second track, and the fourth track intersects the second track anteriorly between the upper and lower right pulmonary veins from a posterior portion of the atrial septum. 24. The method of claim 23, wherein the right atrial cutting track is formed from the superior vena cava to the periphery of the inferior vena cava and between the inferior vena cava and the tricuspid valve. The right atrial cutting track includes a first track along the demarcation ridge around the superior and inferior vena cava, a second track toward the tissue separating the tricuspid valve from the inferior vena cava, and an inferior vena cava between the superior and inferior vena cava. 24. The method of claim 23, comprising a third track along the atrial septum. 30. The method of claim 29, wherein a fourth track is formed from the middle of the superior vena cava forward to the tip of the right atrial appendage at the apex of the track along the demarcation ridge. 28. The method according to claim 27, wherein a fifth track is formed from the fossa ovalis upwardly along the atrial septum to the septal lid. 31. The method of claim 30, wherein a fifth track is formed from the fossa ovalis and upwards along the atrial septum to the septal lid.

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