KR101501837B1 - Multi electrode pulmonary vein circular catheter - Google Patents

Abstract

The present invention relates to a multi-electrode mapping pulmonary vein type circular catheter, comprising: a shaft having a plurality of electrodes formed along a longitudinal direction, the long catheter being connected to one end of a catheter body; And a loop having a plurality of electrodes formed in an open loop shape connected to the distal end of the shaft and formed along the circumferential direction.

Description

{Multi electrode pulmonary vein circular catheter}

The present invention relates to a multi-electrode mapping pulmonary vein type circular catheter, and more particularly, to a catheter catheter that minimizes the movement of a catheter catheter using a multi-electrode contacted with a lesion site without individually detecting lesion sites existing at various locations of the heart tissue To a diagnostic multi-electrode mapping pulmonary vein type circular catheter capable of confirming multiple lesions.

The heartbeat is performed by sequentially stimulating the heart muscle by an electrical signal periodically generated from a part of the heart. However, if an abnormality occurs in the flow of the electric signal, the heart can not be accurately pulsed. This is what is called arrhythmia.

The treatment of cardiac arrhythmias has changed considerably since the introduction of catheter ablation techniques with high frequency currents. In catheter ablation techniques, ablation-catheter is inserted into a single heart through the vein or artery under X-ray control, and tissue that causes cardiac arrhythmia by high-frequency current is destroyed. A precondition for successful execution of catheter ablation is to accurately detect the cause of arrhythmias within the heart. Such detection is diagnosed by electrophysiologic examinations in which electrical potentials are recorded in a spatially resolved state by a mapping-catheter inserted in the heart.

Atrial fibrillation is the most common persistent arrhythmia and can increase heart rate from 100 to 175 or more per minute. Atrial fibrillation is frequently associated with atrial flutter and is associated with a number of medical sequelae such as stroke, atrial hemorrhage, and thrombus formation.

55% of all heart disease patients die from arrhythmia, and atrial fibrillation accounts for 1% to 2% of the total population and accounts for 20% to 30% of ischemic stroke causes. Electrolyte therapy for arrhythmia is a rapidly increasing treatment technology, with more than 7,000 cases per year in Korea and more than 100,000 cases worldwide. However, all of the electrode ceramics for diagnosis and treatment, which require more than 5 pieces per case, depend on imported products. Atrial fibrillation costs $ 12,100 per case. In recent years, there have been companies that produce electrodes for arrhythmia diagnosis in Korea, and more sophisticated electrodes (catheters) using MEMS and simulation technology have become possible.

In finding the lesion causing the atrial fibrillation in the heart, it was difficult to manipulate the position of the catheter stably so that the operator could precisely contact the electrode to the lesion due to the heartbeat. In addition, in the course of identifying the heart region that causes arrhythmia by detecting the bioelectrical signal in the heart, the conventional catheter can detect the electric signal of the heart by only the electrode located in the circular portion, In addition to the circular electrode catheter, the addition of one or more diagnostic type mapping catheters to observe changes in the flow of electrical signals in the heart required difficulties for the operator and burden on the patient.
[Prior Art Literature]
1. Japanese Patent Registration No. 4027411 (Published on December 26, 2007)
2. Japan Public Patent Specification Table 2012-517306 (Date of Publication: August 2, 2012)

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a multi-electrode mapping catheter capable of detecting an electrical signal of a lesion located in various parts of the heart with a minimum mapping using a plurality of mapping electrodes, The present invention provides a multi-electrode mapping catheter capable of precisely controlling an operator through a structure for increasing a contact area of a lesion, and making a line contact or a face contact with a lesion so that a surgeon can stably perform the lesion. The purpose.

In order to achieve the above object, according to the present invention, there is provided a catheter comprising: a shaft having a long conduit connected to one end of a catheter body and having a plurality of electrodes formed along a longitudinal direction; And a loop having a plurality of electrodes formed in an open loop shape connected to the distal end of the shaft and formed along the circumferential direction.

In the present invention, the shaft and the loop may each independently have 2 to 20 electrodes.

In the present invention, the electrodes of the shaft and the loop may each independently have a width of 0.1 to 3 mm.

In the present invention, the electrodes of the shaft and the loop may be independently arranged at intervals of 0.1 to 5 mm.

In the present invention, the distance from the electrode closest to the end of the shaft to the end of the shaft may be 10 to 30 mm.

In the present invention, the length of the shaft is 100 to 150 mm, and the diameter of the shaft may be 0.1 to 5 mm.

In the present invention, the annular diameter of the loop may be 10 to 20 mm, and the diameter of the loop may be 0.1 to 3 mm.

In the present invention, the shaft can be bent from 0 to 180 degrees, and the bending radius can be from 10 to 100 mm.

In the present invention, the distal end of the loop can be extended to the center of the annular shape after being folded inward in an annular shape.

In the present invention, the free end of the loop located at the center of the annular shape may be spherical.

The multi-electrode mapping pulmonary vein type circular catheter according to the present invention can minimize the movement of the catheter catheter by using the multi-electrode contacting the lesion site without individually detecting the lesion parts existing at various locations of the heart tissue, can confirm.

In addition, the catheter according to the present invention can detect an electrical signal of a lesion located in various parts of the heart with a minimum mapping using a plurality of mapping electrodes, Can be precisely adjusted so as to be in line contact or face contact with the lesion, so that the practitioner can perform the patient's operation more stably.

Also according to the present invention, by locating a circular mapping electrode at the distal end of the catheter in the direction in which the distal portion of the catheter is inserted into the human body and placing a plurality of mapping electrodes at the top of the catheter conduit, The electrical signal of the heart that spreads to other distant from the position of the catheter can be sensed from the upper part to the terminal part of the end using the plurality of mapping electrodes located in the catheter conduit. Catheter) can be used. At this time, the operation of the catheter of the practitioner is made easier, and the success rate of the arrhythmia procedure can be improved. Particularly, it is possible to simultaneously obtain an arrhythmogenic vital sign inside and outside of the left atrium of the left atrium, thereby providing a useful procedure for removing a source biological signal in the case of atrial fibrillation.

1 is an overall configuration diagram of a catheter according to the present invention.
2 is a detailed block diagram of a shaft and a loop of a catheter according to the present invention.
3 is a detailed block diagram of a loop of a catheter according to the present invention.
4 is a view showing that the shaft of the catheter according to the present invention can be bent at various angles.
FIG. 5 is a view showing cardiac mapping using a catheter according to the present invention. FIG.

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

1 is an overall schematic view of a catheter according to the present invention in which the catheter of the present invention comprises connectors 10 and 12, a catheter body 20, a shaft 30 and a loop 40.

The connector 10,12 is connected to one end of the catheter body 20 and is capable of connecting the catheter signal cable through the connector 10,12 so that the signal detected from the plurality of electrodes 32,42 To the outside.

The catheter body 20 includes a handle capable of being held by a practitioner, and can be made of a metal or a plastic material. The handle may be configured as a push-pull control type.

The shaft 30 may be a long conduit connected to the other end of the catheter body 20. The shaft 30 may be made of metal (such as stainless steel), plastic (polyurethane, nylon, polyamide, etc.), rubber or a mixture thereof and may be made of a material that is partially different along the longitudinal direction .

The loop (40) may be configured as an open loop that is connected to the distal end of the shaft (30). The loop 40 may be made of metal, plastic, rubber or a mixture thereof.

Fig. 2 is a detailed view of the shaft and loop of the catheter according to the present invention. Fig. 2 is an enlarged view of the open annular loop 40 and the distal end of the catheter end, i.e., the shaft 30, of Fig.

The length of the shaft 30 may be 100 to 150 mm, preferably 110 to 140 mm, more preferably 120 to 130 mm. If the length of the shaft 30 is too long or too short, it is inconvenient in the procedure. Usually, the length from the heart to the right thigh is most convenient for the operator.

The diameter of the shaft 30 may be 0.1 to 5 mm, preferably 1 to 4 mm, more preferably 2 to 3 mm. If the diameter of the shaft 30 is large, a thicker sheath should be used for blood vessel insertion, and the risk of thrombosis increases. On the other hand, when the electrode is too thin, the electrode is not subjected to the force when the catheter is operated, and the electrode is bent or broken.

The shaft 30 has a plurality of electrodes 32 formed along the longitudinal direction thereof.

The electrode 32 may be formed in a ring shape surrounding the outer circumferential surface of the shaft 30. The ring-shaped electrode 32 may be made of a conductive material, particularly a metal material. As the metal, platinum, gold, iridium, cobalt, titanium, nickel, silver, copper, zinc, tin, aluminum, chromium, manganese, magnesium and alloys thereof may be used. The method of forming the ring-shaped electrode 32 is not particularly limited, and a method of fixing the ring-shaped metal material to the shaft 30 with an adhesive, a method of forming the ring-shaped electrode by sputtering, ion beam evaporation, And the like.

The electrode 32 may be connected to a lead wire (not shown), and the lead wire may be inserted into the shaft 30 and connected to the connectors 10 and 12 through the main body 20.

The number of the electrodes 32 formed on the shaft 30 may be 2 to 20, preferably 5 to 15, and more preferably 8 to 12. If the number of the electrodes 32 is too small, spatial resolution for mapping (finding) an arrhythmia lesion is reduced, and if the number of electrodes is too large, the electrode becomes thick and stiff.

The width T ₁ of the electrode 32 may be 0.1 to 3 mm, preferably 0.3 to 2 mm, more preferably 0.5 to 1.5 mm. If the width (T ₁ ) of the electrode 32 is too small, the mapping region is narrowed, while if it is too large, the accuracy and spatial resolution are reduced.

The interval b ₁ of the electrodes 32 may be 0.1 to 5 mm, preferably 0.5 to 4 mm, more preferably 1 to 3 mm. If the spacing b ₁ of the electrodes 32 is too narrow, the mapping portion becomes narrow. If too large, the accuracy and spatial resolution are reduced.

The distance a from the electrode 32 closest to the end of the shaft 30 to the end of the shaft 30 may be 10 to 30 mm, preferably 12 to 28 mm, more preferably 15 to 25 mm . The distance (a) is a distance that matches the position of the anatomical structure targeted for mapping. If the distance is too short or long, it does not meet the purpose of the present electrode ceramic design.

Fig. 3 is a detailed structural view of a loop of a catheter according to the present invention. The loop 40 may be configured as an open circular ring without being closed.

The annular diameter of the loop 40 may be 10 to 20 mm, preferably 12 to 18 mm, more preferably 13 to 17 mm. The above range of the annular diameter of the loop 40 is an empirical value determined based on the diameter of a normal pulmonary vein. If it is too small, the electrode can not contact the pulmonary vein. If it is too large, the electrode does not enter the pulmonary vein.

The diameter of the loop 40 may be 0.1 to 3 mm, preferably 0.5 to 2.5 mm, more preferably 1 to 2 mm. If the diameter of the loop 40 is too small, the electrode can not maintain its cylindrical shape in the pulmonary vein, and it is distorted. If it is too thick, it becomes difficult to perform intravascular insertion and intracardiac manipulation.

The loop 40 has a plurality of electrodes 42 formed along an annular circumferential direction.

The electrode 42 may be formed in a ring shape surrounding the outer circumferential surface of the loop 40. The electrode 42 of the loop 40 may be made of a conductive material, in particular a metal material, and the forming method may be the same as the electrode 32 of the shaft 30, similar to the electrode 32 of the shaft 30. [

The electrode 42 may be connected to a lead wire (not shown), and the lead wire may be inserted into the loop 40 and connected to the connector 10, 12 or the like via the shaft 30 and the main body 20.

The number of electrodes 42 formed in the loop 40 may be 2 to 20, preferably 5 to 15, and more preferably 8 to 12. If the number of the electrodes 42 is too small, spatial resolution for mapping (finding) the arrhythmia lesion is reduced, and if the number of electrodes is too large, the electrode becomes thick and stiff.

The width T ₂ of the electrode 42 may be 0.1 to 3 mm, preferably 0.3 to 2 mm, more preferably 0.5 to 1.5 mm. If the width (T ₂ ) of the electrode 42 is too small, the mapping region is narrowed, while if it is too large, the accuracy and spatial resolution are reduced.

The interval b ₂ of the electrodes 42 may be 0.1 to 5 mm, preferably 1 to 4.5 mm, more preferably 2 to 4 mm. If the spacing b ₂ of the electrodes 42 is too narrow, the mapping region becomes narrow. If too large, the accuracy and spatial resolution are reduced.

The distal end 44 of the loop 40 may be bent to the inside of the annular shape and then extend to the center of the annular shape. Thus, when the distal end portion 44 of the loop 40 is bent inward, it is possible to map the wall of the pulmonary vein while maintaining the shape of the loop even after inserting the electrode ceramics into the pulmonary vein.

The free end 46 of the loop 40 located at the center of the annulus may be spherical. As such, the free end 46 of the loop 40 is spherical, thereby preventing the free end 46 from damaging the heart wall when the electrode is pressed.

4 is a view showing that the shaft of the catheter according to the present invention can be bent at various angles.

The distal end of the shaft 30 is bendable from 0 to 180 degrees, as shown, and can be bent at more angles if desired. The bending of the shaft 30 can be performed by operating a handle of a push-and-pull control type. In this manner, since the shaft 30 can be curved from 0 to 180 degrees, it facilitates insertion of the catheter inside the pulmonary vein as well as easy access to the portion where a large number of catheters are difficult to locate.

The radius of curvature r of the distal end of the shaft 30 may be 10 to 100 mm, preferably 20 to 80 mm, more preferably 30 to 70 mm. If the radius of curvature (r) of the shaft 30 is too small, proper manipulation in a large heart is impossible, and if it is too large, operation in a small heart is difficult and dangerous.

FIG. 5 is a view showing cardiac mapping using a catheter according to the present invention, showing the mapping of right ventricular septal and left atrial ceiling using a multi-electrode mapping pulmonary vein circular catheter according to the present invention. Thus, there is an advantage that a more accurate bio-signal can be discriminated by using a plurality of mapping electrodes.

Table 1 shows the detailed configuration of the catheter manufactured according to one example of the present invention.

Feature Specification Loop Style Fixed Loop Diameter 15mm Catheter Size 4F loop, 7F Shaft Number of Electrodes 20 (Loop: 10, Shaft: 10) Electrode Size 1mm Type, 1mm band Electrode Space Loop: 3-3-3mm, Shaft: 2-2-2mm Shaft Deflection 180 ° uni-directional Handle Push-pull style

As described above, the present invention can identify multiple lesions while minimizing the movement of the catheter catheter using multi-electrodes in contact with the lesion site, without individually detecting lesion sites existing at various locations of the heart tissue, There is provided a multi-electrode mapping catheter capable of sensing an electrical signal of a lesion located in various parts of the heart with a minimum mapping using a plurality of mapping electrodes. The structure for increasing the contact area of the lesion allows the operator to precisely adjust the lesion to be in line contact or face contact with the lesion, thereby allowing the surgeon to perform the lesion more stably.

Further, according to the present invention, by locating a circular mapping electrode in the distal end (loop) of the catheter in the direction in which the distal portion of the catheter is inserted into the human body and placing a plurality of mapping electrodes on top of the catheter conduit (shaft) The electrical signals of the heart that spread from the location of the lesion detected by the mapping electrode to the other distant can be sensed from the upper part to the electrode of the terminal part by using a plurality of mapping electrodes located in the catheter conduit and a linear resection for the left atrium or right atrium The procedure can be performed without additional electrode ceramics.

10, 12: connector
20: catheter body
30: Shaft
32, 42: electrode
40: Loop
44: loop end
46: loop free end

Claims (10)

A shaft comprising a long conduit connected to one end of the catheter body and having a plurality of ring shaped electrodes formed along a longitudinal direction; And
And a loop having a plurality of ring-shaped electrodes formed in an open loop shape connected to an end of the shaft and formed along the circumferential direction,
The shaft and the loop each independently have 2 to 20 electrodes,
The electrodes of the shaft and the loop each have a width of 0.1 to 3 mm independently,
The electrodes of the shaft and the loop are independently arranged at intervals of 0.1 to 5 mm,
The distance from the electrode closest to the end of the shaft to the end of the shaft is 10 to 30 mm,
The length of the shaft is 100 to 150 mm, the diameter of the shaft is 0.1 to 5 mm,
The annular diameter of the loop is 10 to 20 mm, the diameter of the loop is 0.1 to 3 mm,
The shaft is bendable from 0 to 180 degrees, the bending radius is from 10 to 100 mm,
The distal end of the loop is bent inwardly into an annular shape and then extends to the center of the annular shape,
And the free end of the loop located in the annular center is of a spherical shape. delete delete delete delete delete delete delete delete delete

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