KR101000320B1 - Bipolar electrode type guide wire and Catheter system using the same - Google Patents

Abstract

The present invention relates to a bipolar electrode type guide wire and a catheter system using the same. The bipolar electrode-type guide wire according to the present invention is made of a metal material, the wire main body is disposed long in one direction to be inserted into the tubular organ of the living body, the insulating material is coated on the outer peripheral surface of the wire body to insulate the wire, the wire The wire main body is electrically connected to the first electrode attached to one end of the main body, the second electrode attached to one end of the wire main body to be separated from the first electrode, and the high frequency generator generating the high frequency current and the first electrode. Are disposed along the wire body so as to electrically connect the first conductor attached to the first electrode and the high frequency generator generating the high frequency current and the second electrode. It is characterized by including an insulated second conductor.

Guide wire, catheter, high frequency generator

Description

Bipolar electrode type guide wire and catheter system using the same

The present invention relates to a guide wire and a catheter system using the same, and more particularly, to perform high frequency heat treatment such as vascular occlusion, tumor removal, coronary structure occlusion, fistula occlusion, and short cut (shunt, short) occlusion. And a catheter system using the same.

In various cases, such as vascular malformation such as arteriovenous malformation or bleeding diseases caused by organ rupture, occlusion or embolization that blocks the blood vessels at the bleeding site is necessary. .

Conventional embolization generally occludes blood vessels using embolic materials such as polyvinyl alcohol, gel foam, anhydrous ethanol, microspheres, coils, balloon separation. That is, the catheter was inserted along the blood vessel to the affected site, and then the vessel was occluded by injecting an embolic material into the affected area through the catheter.

However, when the blood vessel is occluded using the embolic material, there may be a side effect of using the embolic material. In other words, embolism can be reversed to block adjacent normal blood vessels, and when it enters the vein, it can block pulmonary artery and cause itrogenic embolism.

On the other hand, many methods of occluding the blood vessels through radiofrequency ablation (RFA), which occludes blood vessels by using a high frequency current without using embolic materials. FIG. 1 is a schematic diagram illustrating high frequency thermal therapy using a catheter, and FIG. 2 is a view for explaining high frequency thermal therapy performed using a catheter and an electrode for a patient who has a bleeding disease caused by a traumatic kidney injury. As a photograph, FIG. 2A is a state before treatment, FIG. 2B is a state where a catheter and a guide wire are inserted, and FIG. 2C is a state after treatment.

In order to perform radiofrequency ablation, a catheter (c) is first inserted into the patient's body, and the proximal segment of the catheter is approached through the blood vessel to the area where the lesion has occurred. Inserting the catheter (c) through the blood vessels is a very delicate process and is done through an angiographic fluoroscopy system. When the proximal end of the catheter (c) reaches the lesion, a high frequency current is applied to the lesion by applying power to a high frequency generator (not shown), which will be described in more detail below.

The catheter c has a hollow shape, and a lumen (not shown) is formed therein. A guide wire (not shown) is coaxially inserted into the lumen of the catheter c, and the distal end thereof is catheter (not shown). It protrudes and exposes about c). Therefore, when the proximal end of the catheter c reaches the region where the lesion is generated, the proximal end of the guide wire is also located in the same region. The guide wire is a metal material and is electrically connected to the high frequency generator. On the other hand, a ground pad (not shown) is attached to the patient's body (outer skin), which is also electrically connected to the high frequency generator. When power is applied to the high frequency generator, a path of current flow from the guide wire to the ground pad is formed. In this process, the friction energy caused by the vibration of the ions raises the temperature of the tissue, inducing coagulation necrosis, thereby occluding the blood vessel.

Figure 2a is a case of rupture of the kidney and false aneurysm of the kidney artery due to trauma. It can be seen that there is a large amount of bleeding in the region indicated by reference numeral b in FIG. 2A by the trauma. In FIG. 2B, the bleeding region is reached through the blood vessel while the guide wire w is inserted into the catheter c. Radio frequency heat treatment was performed in this region using high frequency current, and the result is shown in FIG. 2C. have. Looking at Figure 2c, unlike in Figure 2a it can be seen that the bleeding has stopped and can be confirmed that the blood vessels are effectively occluded by radiofrequency heat treatment.

High frequency thermal therapy using the catheter system of the above-described configuration is effective because it can prevent side effects such as occlusion of normal blood vessels, which may be caused by the use of an embolic material. However, side effects may occur in normal organs such as the heart, nervous system, and skin, in addition to the region in which the lesion is generated in the path of current transfer (path from the affected part to the ground pad). That is, the ground pad is attached to the skin of the patient, there is a problem that the high-frequency current does not act locally only on the affected area, but acts from the guide wire to the ground pad to affect normal organs and tissues.

In addition, the catheter system using the above configuration is inconvenient in use, such as to attach a ground pad to the patient for the procedure.

The present invention is to solve the above problems, can locally induce coagulation necrosis only in the region where the lesion, such as vascular malformations, tumors, bleeding, etc. can be very effective high-frequency heat treatment without side effects such as damage to normal tissues Rather, the object of the present invention is to provide a bipolar electrode guide wire and a catheter system using the same, which is made of a very simple configuration and has increased the convenience and economy of the procedure.

Guide wire of the bipolar electrode method according to the present invention for achieving the above object is made of a metal material, the wire main body is disposed long in one direction to be inserted into the tubular organ of the living body, is coated on the outer peripheral surface of the wire body An insulating material for insulating the wire, a first electrode attached to one end of the wire body, a second electrode spaced apart from the first electrode at a predetermined distance, and a high frequency generator for generating a high frequency current. Along the wire body to be electrically connected to the first electrode and along the wire body to electrically connect the first electrode and the high frequency generator for generating a high frequency current and the second electrode to be electrically connected to the first electrode. It is disposed long and attached to the second electrode, and electrically insulated from the first lead. It is characterized by the fact that it consists of a second lead wire.

According to the present invention, the first electrode and the second electrode is preferably formed in a ring shape is attached to the outer peripheral surface of the wire body.

In addition, according to the present invention, the distance between the first electrode and the second electrode is preferably 1mm to 50mm.

In addition, according to the present invention, the first electrode and the second electrode is formed in an annular shape is fitted to the outer peripheral surface of the wire body, the outer diameter of the first electrode and the second electrode are the same and spaced apart from each other It is preferable that an insulator having an outer diameter equal to an outer diameter of the first electrode and the second electrode is inserted between the first electrode and the second electrode so that the first electrode and the second electrode are not stepped.

As described above, the catheter system according to the present invention is very effective because it is possible to intensively radiofrequency heat treatment only in the region where the lesion is generated, and has the advantage of not causing adverse effects on other tissues or blood vessels.

In addition, according to the present invention, there is an advantage that the workability is improved by eliminating the inconvenience of using a conventional ground pad.

In addition, in one embodiment of the present invention has the advantage that it is easy to insert the guide wire into the branching vessel by forming one end of the guide wire of the bipolar electrode method.

Hereinafter, with reference to the accompanying drawings, a bipolar electrode guide wire according to a preferred embodiment of the present invention and a catheter system using the same will be described in more detail.

FIG. 3 is a schematic perspective view of a bipolar electrode guide wire and a catheter system according to a preferred embodiment of the present invention, FIG. 4 is a schematic cross-sectional view taken along line IV-IV of FIG. 3, and FIG. 5A is a schematic view of line Va-Va of FIG. 4. 5B is a schematic cross-sectional view taken along the line Vb-Vb of FIG. 4.

3 to 5B, the catheter system 100 according to a preferred embodiment of the present invention includes a catheter 10 and a bipolar electrode guide wire 50.

The catheter 10 is formed to be inserted into a coronary organ of a living body such as a blood vessel and has a long circular cross section. The catheter 10 is generally classified by thickness and is divided into a general catheter and a microcatheter formed with a very small diameter. In the case of a microcatheter, the diameter is about 0.3 mm to 0.5 mm, and the length may vary, but for example, 80 cm to 160 cm. The catheter 10 is made of a flexible material because it is inserted into the human body through blood vessels. As the material of the catheter, fluororesins such as polytetrafluoroethylene (PTFE, PolyTetraFluoroEthylene), hexafluoropropylene copolymer (FEP), and perfluoroalkyl vinyl ether copolymer (PFA), known as Teflon resin, are used. The polytetrafluoroethylene is a crystalline polymer having a melting point of 327 ° C. and a continuous use temperature of 260 ° C., and can be stably used from low temperature (−268 ° C.) to high temperature. In addition, it has a strong chemical resistance and can be used stably without reactivity with various solvents such as acids and alkalis. In addition, materials such as polyethylene, polystyrene, and polyurethane may be used. Such a fluorine resin to reduce the friction when the guide wire 50 of the bipolar electrode type to be described later is inserted into the catheter 10 to facilitate the insertion. On the other hand, the outer peripheral surface of the catheter 10 has a hydrophilic coating (hydrophilic coating) to facilitate the insertion into the blood vessels.

The catheter 10 is a hollow type with both ends open and a lumen 13 is formed therein, which is disposed coaxially along the longitudinal direction of the catheter 10. In addition, in the present embodiment, the lumen 13 is separated into the first lumen 11 and the second lumen 12 by the partition wall 14 formed along the catheter 10. The first lumen 11 includes a catheter 10 including both ends of the catheter 10, that is, a proximal end 10p inserted into the body and a distal end 10d disposed outside the body. It is formed through the whole. The first lumen 11 serves as a passage for inserting the bipolar electrode guide wire 50 to be described later. The second lumen 12 functions as a passage for injecting fluid into the inside of the balloon 60, which will be described later. The second lumen 12 proximal to the catheter 10 from a portion where the balloon 60 is disposed in the entire area of the catheter 10. Extending toward the distal end 10d opposite the end 10p. Accordingly, an inlet 17 is formed at one end of the second lumen 12 to penetrate between the inner circumferential surface and the outer circumferential surface of the catheter 10 to allow fluid to flow into the balloon 60. In addition, a fluid injection pipe 18 is disposed at the other end of the second lumen 12. The fluid injection pipe 18 is also hollow and has a third lumen (not shown) coaxially formed therein. The third lumen is for guiding the fluid injected into the balloon 60 to be described later to the second lumen 12 side, and the third lumen and the second lumen 12 communicate with each other. The fluid injection pipe 18 is fitted to the hub (h) to which the catheter 10 is fitted and fixed, and the second lumen 12 and the third lumen are connected to each other inside the hub h. It is.

In this embodiment, the balloon 60 is shown in a combined form, but more generally, a catheter of a non-coupled form is employed. In the case of a non-coupled type catheter, the second lumen 12 or the fluid injection tube 18 for injecting the fluid into the balloon is not provided.

In addition, the distal end 10d of the catheter 10 is provided with an insertion hub 15 having an insertion hole formed therein for easy insertion of the guide wire 50 of the bipolar electrode type described later. The insertion port is formed to be tapered so that the diameter gradually decreases toward the proximal end 10p. Similarly, an injection hub 16 having an inclined injection hole formed therein is installed at the end of the fluid injection pipe 18 to facilitate the injection of the fluid.

The bipolar electrode guide wire 50 according to the present invention includes a wire body 51, a first electrode 53, and a second electrode 54.

The wire body 51 is disposed long to be inserted into the blood vessel in a state of being fitted to the first lumen 11 of the catheter 10, and is formed flexibly. In addition, the wire body 51 is made of a metal material to perform the basic function of guiding the path to the area where the lesion occurred along the blood vessel, the operator position the guide wire 50 in the vessel through the angiography system Can be identified.

On the other hand, for convenience of description, the wire body 51 is illustrated as being straight in shape, but in fact, the tip of the wire body 51 is formed in a coil shape and can be bent very flexibly, so it is easy to move even in a narrow vessel. . In addition, unlike the other parts, a tip such as platinum is used to secure the flexibility of the wire main body 51. The outer circumferential surface of the wire body 51 is coated with an insulating material 52 of an insulating material, for example Teflon resin, to insulate the wire body 51.

 The first electrode 53 is formed in an annular shape and fitted to the outer circumferential surface of one end of the wire body 51. However, the insulating material 52 and the coating | coating agent 58 mentioned later are interposed between the wire main body 51, and the 1st electrode 53 and the wire main body 51 are electrically insulated.

Like the first electrode 53, the second electrode 54 is formed in an annular shape, and is spaced apart from the first electrode 53 by a predetermined distance to be fitted to the outer peripheral surface of one end of the wire body 51. Similarly, the insulating material 52 and the coating | coating agent 58 mentioned later are interposed between the wire main body 51, and the 2nd electrode 53 and the wire main body 51 are electrically insulated.

The first electrode 53 is electrically connected to the high frequency generator 70 to be described later by the first conductor 56. That is, the first conductive line 56 is disposed along the wire body 51 so that one end thereof is connected to the first electrode 53 and the other end thereof is connected to the anode (+) of the high frequency generator 70.

In addition, the second electrode 54 is electrically connected to the high frequency generator 70 to be described later by the second lead 57. Like the first lead 56, the second lead 57 is long along the wire body 51, one end of which is connected to the second electrode 54, and the other end of which is the cathode (−) of the high frequency generator 70. Is connected to.

The first conductive wire 56 and the second conductive wire 57 are insulated from each other by the coating agent 58. That is, in a state where the first conductive wire 56 and the second conductive wire 57 are spaced apart from each other, the molten polymer coating material 58 includes the first conductive wire 56 and the second conductive wire 57. After covering the whole body 51, when the predetermined time passes, the coating | coating agent 58 of a molten state will solidify. In this state, since the coating material 58 made of a polymer separates the first conductive wire 56 and the second conductive wire 57, they can be electrically insulated from each other.

However, the coating material does not cover the entire wire body 51, and like the covering of the electric wire, for example, the first conductive wire 56 and the second conductive wire 57 may be independently wrapped to insulate each other. However, although the method of independently wrapping the first conductor 56 and the second conductor 57 may achieve the purpose of insulation, there is a problem in that the outer circumferential surface of the guide wire 50 is not smoothed. That is, when a method of independently insulating the conductors is adopted, a step occurs between the wire body 51 and the first conductor and between the wire body 51 and the second conductor, so that the guide wire 50 is formed in the blood vessel. This has an unfavorable effect on being inserted in. Accordingly, the outer coating surface of the guide wire 50 is stepped by covering the wire main body 51 and the first and second conductive wires 56 and 57 together as in this embodiment so that the whole is integrally formed. It can be formed smoothly without being lost.

Similarly, the outer diameters of the first electrode 53 and the second electrode 54 may be coated with a coating agent so that the step is not formed on the outer circumferential surface of the guide wire 50 by the first electrode 53 and the second electrode 54. It is formed equal to the outer diameter of 58). The annular insulator 55 having the same outer diameter is also inserted between the first electrode 53 and the second electrode 54 which are spaced apart from each other. Accordingly, the entire outer circumferential surface of the bipolar electrode guide wire 50 according to the present invention is smoothly formed without stepping.

On the other hand, the distance between the first electrode 53 and the second electrode 54 is preferably set to 1mm ~ 50mm. As will be described later, a lesion such as a blood vessel or a tumor is positioned between the first electrode 53 and the second electrode 54, and an AC current is propagated between the first electrode 53 and the second electrode 54. They may clog blood vessels or cauterize the tumor. Accordingly, when the distance between the first electrode 53 and the second electrode 54 is less than 1 mm, an area where current is propagated is too small to effectively expect a wider lesion, and the two electrodes are mutually effective. It is not desirable to be in contact. In addition, when the distance is more than 50mm there is a problem that the effective propagation is difficult to propagate the current is not smooth, it may affect the normal tissues other than the lesion site is not preferable.

The bipolar electrode-type guide wire 50 having the above configuration may vary in diameter depending on the purpose, but the outer diameter of the guide wire 50 according to the present embodiment is formed to be approximately 0.016 inches. For reference, in the present embodiment, the outer diameter of the catheter 10 is set to about 0.038 inches or more.

The balloon 60 is hermetically coupled to the outer circumferential surface of the catheter 10. More specifically, the balloon 60 is coupled to the outer circumferential surface of the catheter 10 while surrounding the area where the inlet 17 of the second lumen 12 is disposed. Balloon 60 is to expand in the blood vessel to block the blood flow is made of a flexible material. That is, when the fluid (generally used for angiography) flows between the inner circumferential surface of the balloon 60 and the outer circumferential surface of the catheter 10 via the inlet 17 via the second lumen 12, the balloon 60 expands. Done. Accordingly, the proximal end 10p of the catheter 10 remains in a contracted state before reaching the lesion area, and expands when fluid is injected in the lesion area. Since the outer circumferential surface of the balloon 60 is in contact with blood, it is preferable that the outer circumferential surface is formed of an antithrombogenic material, and that a considerable amount of heat is generated during high frequency heat treatment, which will be described later.

The radiofrequency generator 70 generates high frequency alternating current and is used for electrosurgery, and is used to locally cut or coagulate living tissue. In the present embodiment, the first electrode 53 of the bipolar electrode type guide wire 50 is electrically connected to the anode (+) of the high frequency generator 70 by the first conductor 56 and the second electrode. 54 is electrically connected to the cathode (-) of the high frequency generator 70 by the second lead 57. Accordingly, in the present embodiment, as described in the related art, the first electrode 53 and the second electrode 54 act as an anode and a cathode, respectively, instead of a monopolar electrode using a ground pad. Form a bipolar electrode. When power of about 20 watts is applied to the high frequency generator 70, an alternating current in the high frequency region 200 to 1200 kHz is propagated between the first electrode 53 and the second electrode 54. As the alternating current propagates, frictional energy caused by the vibration of ions raises the temperature of biological tissues such as blood vessels and tumors to induce coagulation necrosis, thereby occluding bleeding blood vessels or cauterizing tumors.

When performing high frequency thermal therapy using unipolar electrodes, there is inconvenience in using a ground pad attached to the patient as described above, and above all, obstruction due to the long transmission path of current from the electrode to the ground pad. There was a problem affecting other major vessels or tissues that accompany the blood vessels to be done. However, the use of the bipolar electrode as in the present invention has the advantage that the local delivery path is formed only between the first electrode 53 and the second electrode 54 does not cause side effects to other tissues or blood vessels.

On the other hand, the balloon 60 is necessary for the effective high-frequency heat treatment when the blood flow in the bleeding area is fast. In other words, heat treatment through the high-frequency generator 70 is to induce coagulation by increasing the temperature of the tissue, when the blood flow is fast heat is transferred to the lesion rather than concentrated in the so-called heat sedimentation effect (heat sink effect) occurs, so it is difficult to induce coagulation necrosis. In this case, the balloon 60 is inflated in the blood vessel to temporarily block blood flow and perform high frequency heat treatment, thereby enabling an effective procedure.

Until now, the tip portion (the proximal end 10p side of the catheter) of the guide wire 50 of the bipolar electrode type has been described and illustrated as being straight, but may have various forms. 6 and 7 show an embodiment in which the tip portion of the guide wire 50 is curved.

Figure 6 is a schematic perspective view of the main part of the bipolar electrode-type guide wire according to another embodiment of the present invention. Figure 7 is a schematic perspective view of the main portion of the bipolar electrode guide wire according to another embodiment of the present invention.

Referring to FIG. 6, the tip end portion of the guide wire is bent and disposed in a direction intersecting the longitudinal direction of the catheter. In addition, referring to Figure 7, the tip portion of the guide wire is formed to be completely bent in the letter 'U' shape. The reason why the tip of the guide wire is formed to be bent is to facilitate insertion into the blood vessel. That is, the blood vessels form branches from the coarse blood vessels and branch into narrow blood vessels. The branching blood vessels are arranged in a direction intersecting with the coarse blood vessels. When the guide wire 50 is to be inserted into the branched blood vessel while traveling along the thick blood vessel, it is advantageous that the tip portion of the guide wire is bent as shown in FIG. 6. That is, when the guide wire 50 of the bipolar electrode system is rotated at the portion where the blood vessel branches, the bent end of the guide wire can be oriented toward the branched blood vessel.

In addition, when the blood vessel is formed to be completely reversed and branched, and it is necessary to insert the guide wire 50 into the blood vessel is completely reversed, as shown in Figure 7, the leading end of the guide wire is formed in the letter 'U' It is possible to insert easily.

The unexplained member denoted by reference numeral 59 is made of an insulating material as an insulating cap and is used to insulate the distal end of the wire body 51.

Until now, the guide wire and the catheter system according to the present invention has been described as being used in connection with a high frequency generator, but is not necessarily limited thereto and may be used in connection with a microwave generator or the like according to a lesion.

Although the present invention has been described with reference to the embodiments illustrated in the accompanying drawings, this is merely exemplary, and it will be understood by those skilled in the art that various modifications and equivalent other embodiments are possible. There will be. Accordingly, the true scope of protection of the invention should be defined only by the appended claims.

1 is a schematic diagram for explaining a radiofrequency thermal therapy using a catheter.

FIG. 2 is a photograph illustrating a radiofrequency thermal therapy performed using a catheter and an electrode for a patient in which a bleeding disease due to trauma is caused by trauma. FIG. 2A is a state before treatment, and FIG. The wire is inserted and FIG. 2C is after the treatment.

3 is a schematic perspective view of a bipolar electrode guide wire and catheter system according to a preferred embodiment of the present invention.

4 is a schematic cross-sectional view taken along the line IV-IV of FIG. 3.

5A is a schematic cross-sectional view taken along the line Va-Va of FIG. 4, and FIG. 5B is a schematic cross-sectional view taken along the line Vb-Vb of FIG. 4.

Figure 6 is a schematic perspective view of the main portion of the bipolar electrode-type guide wire according to another embodiment of the present invention.

Figure 7 is a schematic perspective view of the main part of the guide wire of the bipolar electrode method according to another embodiment of the present invention.

<Explanation of symbols for the main parts of the drawings>

100 ... Catheter System 10 ... Catheter

50 ... bipolar electrode guide wire 51 ... wire body

52 ... insulation material 53 ... first electrode

54 ... second electrode 55 ... insulator

56 ... first conductor 57 ... second conductor

58 ... sheath 59 ... insulation cap

60 ... Balloon 70 ... High Frequency Generator

Claims (8)

A wire body made of a metal material and disposed to extend in one direction so as to be inserted into a tubular organ of a living body; An insulating material coated on an outer circumferential surface of the wire body to insulate the wire; A first electrode attached to one end of the wire body; A second electrode spaced apart from the first electrode by a predetermined distance and attached to one end of the wire body; A first lead disposed along the wire body and attached to the first electrode to electrically connect the high frequency generator for generating a high frequency current to the first electrode; And And a second lead disposed along the wire body so as to electrically connect the high frequency generator generating the high frequency current and the second electrode to the second electrode and electrically insulated from the first lead. , The first electrode and the second electrode is formed in an annular shape is a bipolar electrode guide wire, characterized in that attached to the outer peripheral surface of the wire body. delete The method of claim 1, Guide wire of the bipolar electrode type, characterized in that the front end of the wire body is formed bent. The method of claim 3, Guide wire of the bipolar electrode type, characterized in that the front end portion of the wire body is bent in a 'U' shape. The method of claim 1, And an insulator disposed between the first electrode and the second electrode. The method of claim 1, The distance between the first electrode and the second electrode is a bipolar electrode guide wire, characterized in that 1mm to 50mm. The method of claim 1, The first electrode and the second electrode is formed in a ring shape is fitted to the outer peripheral surface of the wire body, the outer diameter of the first electrode and the second electrode are the same,  An insulator having an outer diameter equal to the outer diameter of the first electrode and the second electrode is inserted between the first electrode and the second electrode so that the first electrode and the second electrode are not spaced apart from each other. A bipolar electrode guide wire. A hollow catheter inserted into a coronal organ of a living body, the both ends of which are open and in which lumens are coaxially formed; And A wire body made of a metal material and disposed long in one direction and fitted to the catheter, an insulating material coated on an outer circumferential surface of the wire body to insulate the wire, a first electrode attached to one end of the wire body, and A second electrode which is spaced apart from the first electrode by a predetermined distance and attached to one end of the wire body, the high frequency generator which generates a high frequency current and the first electrode to be long along the wire body to electrically connect the first electrode A first wire connected to the electrode, a high frequency generator generating a high frequency current, and a second electrode disposed along the wire body to electrically connect the second electrode to be attached to the second electrode, and electrically insulated from the first wire It includes; a bipolar electrode-type guide wire having a second conductive wire, The first electrode and the second electrode is formed in a ring shape catheter system, characterized in that attached to the outer peripheral surface of the wire body.

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