KR20080110224A - Catheter system - Google Patents

Abstract

A catheter system is provided, in which convenience and profitability of the surgical operation is increased because the ablation of coagulation can be locally induced in the domain in which lesion is generated. A catheter system(100) comprises: a catheter(10) of the hollow shape which is inserted into the fistula of organism, is made of the insulating material and both ends are opened, and in which lumen is coaxially formed in the inner side; a shape maintenance complex(30) for the electrode exposed outside which is arranged in the longitudinal direction of the catheter, is inserted and set up between the inner circumference and outer circumference of the catheter to support the catheter; and a guide wire(50) of which one end is protruded from a lumen and is arranged at an interval from shape maintenance complex for the electrode.

Description

Catheter system

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. 2B is a catheter and a guide. The wire is inserted and FIG. 2C is after the treatment.

3 is a schematic partial cutaway perspective view of a catheter system in accordance with a preferred embodiment of the present invention.

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

FIG. 5 is a schematic cross-sectional view taken along the line VV of FIG. 4.

6 is a schematic perspective view of a major portion of a catheter system in accordance with another embodiment of the present invention.

7 is a schematic perspective view of a major portion of a catheter system in accordance with another embodiment of the present invention.

8 is a schematic exploded perspective view for explaining the electrode member applied to another embodiment of the present invention.

FIG. 9 is a schematic cross-sectional view taken along line VII-VII of FIG. 8.

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

100 ... Catheter System 10 ... Catheter

30 ... shape holder 50 ... guide wire

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

The present invention relates to a catheter system, and more particularly, by placing an electrode connected to a high frequency generator in a lesion area using a catheter, vascular occlusion, tumor removal coronary structure occlusion, fistula occlusion, and shunt. And a catheter system capable of performing high frequency thermal therapy procedures such as occlusion.

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 using the embolic material to occlude blood vessels, side effects may occur due to the use of 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. 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). 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, its purpose is to provide a catheter system with a very simple configuration, which increases the convenience and economics of the procedure.

The catheter system according to the present invention for achieving the above object, is inserted into the coronary organ of the living body, made of an insulating material, both ends of the open and the lumen is coaxially formed therein, the catheter of the catheter It is disposed in the longitudinal direction and is inserted between the inner circumferential surface and the outer circumferential surface of the catheter so that the shape of the lumen is maintained to support the catheter, both ends protruding from the catheter and exposed to the outside as an electrically conductive material And a guide wire which is made of a shape retainer and an electrically conductive material and is inserted coaxially into the lumen so that one end thereof protrudes from the lumen and is spaced a predetermined distance from one end of the shape retainer for the electrode. have.

According to the present invention, it is preferable that the electrode shape retainer has a spiral shape and is wound between an inner circumferential surface and an outer circumferential surface of the catheter or has a mesh shape.

In addition, according to the present invention, the lumen is separated from the first lumen formed by the first lumen penetrating from one end to the other end of the catheter, the partition wall and one end penetrates between the inner and outer peripheral surface of the catheter The second lumen is in communication with the outside of the catheter, and is sealed to the outer circumferential surface of the catheter in a state wrapped around the one end of the second lumen and the balloon is expanded when the fluid is injected through the second lumen, and the balloon It is preferable to further include a hollow fluid injection tube having a third lumen connected to the second lumen formed therein to guide the injected fluid to the second lumen of the catheter.

Hereinafter, with reference to the accompanying drawings, a catheter system according to a preferred embodiment of the present invention will be described in more detail.

3 is a schematic partial cutaway perspective view of 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. 5 is a schematic cross-sectional view taken along line V-V of FIG. 4.

3 to 5, the catheter system 100 according to the preferred embodiment of the present invention includes a catheter 10, a shape retainer 30 for electrodes, a guide wire 50, a balloon 60, and a high frequency generator. 70 is provided.

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 the blood vessel. 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 above fluorine resins are electrically insulating materials. 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. This fluorine resin reduces friction when the guide wire 50 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 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 is proximal to the catheter 10 from a portion where the balloon 60 is disposed in all areas of the catheter 10. It extends opposite the stage 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. have.

In addition, the distal end 10d of the catheter 10 is provided with an insertion hub 15 having an insertion hole formed therein to facilitate the insertion of the guide wire 50 to be 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 electrode shape retainer 30 is intended to maintain the shape of the lumens 11 and 12 formed inside the catheter 10. That is, since the catheter 10 is made of a flexible material, the shape of the first lumen 11 and the second lumen 12 may be deformed even by a slight external force. When the diameter is narrowed in some regions of the first lumen 11 by the external force, it is not easy to insert the guide wire 50 to be described later. When the diameter of the second lumen 12 is narrowed, the balloon 60 will be described later. There is a problem that it is not easy to inject the fluid. The shape retainer 30 is inserted between the inner circumferential surface and the outer circumferential surface of the catheter 10 and is disposed over the entire length of the catheter 10 so that the shape of the first and second lumens 11 and 12 is not deformed and is circular. To maintain. In the present embodiment, the shape retainer 30 is spirally wound between the inner peripheral surface and the outer peripheral surface of the catheter 10 is installed.

In addition, in the present invention, the shape retainer 30 is different from the conventional shape retainer in that the shape retainer 30 functions as an electrode in addition to the shape retainer of the lumen. Accordingly, in the present embodiment, the shape retainer 30 is made of an electrically conductive material such as copper and stainless steel, and both ends of the shape retainer 30 protrude from the catheter 10 and are exposed to the outside. In the case of the conventional shape retainer, the shape retainer 30 in the present invention was generally not disposed throughout the catheter, but is disposed locally only at a relatively more flexible portion of the catheter, that is, the proximal end of the catheter. In addition to maintaining the shape of the bar to be performed as a electrode, there is a big difference in that the catheter 10 is disposed throughout and the end is electrically connected to the high frequency generator 70 to be described later. On the other hand, in the present embodiment, the shape retainer 30 is wound in a spiral, but other forms of embodiments may exist. This will be described later.

The guide wire 50 is coaxially inserted into the first lumen 11 of the catheter 10 to guide the path of the catheter 10 to the lesion along the blood vessel. Guide wire 50 is made of a metal material to have an electrical conductivity. The outer circumferential surface of the guide wire 50 is coated with an insulating material of a polymer material such as Teflon resin. More specifically, one end of the guide wire 50, that is, the center portion between the portion of the guide wire 50 protruding from the lumen of the catheter 10 and the other end connected to the high frequency generator to be described later is coated. The length of the guide wire 50 protruding from the lumen is about 0.5 to 2 cm. In this embodiment, the guide wire 50 has a diameter of approximately 0.016 inches. In addition, the tip end of the guide wire 50 is to be inserted into the micro-vessels, using a material such as platinum is formed more flexible than other areas of the guide wire 50. When the guide wire 50 is inserted into the first lumen 11 of the catheter 10, one end thereof is disposed to protrude beyond the first lumen 11. Accordingly, one end of the guide wire 50 and one end of the electrode shape retainer 30 are spaced apart from each other in a protruding state from the catheter 10. The other end of the guide wire 50 is electrically connected to the high frequency generator 70 to be described later.

The balloon 60 is hermetically coupled to an outer circumferential surface of the catheter 10, and more specifically, surrounds an area in which the inlet 17 of the second lumen 12 is disposed and is coupled to the outer circumferential surface of the catheter 10. 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 a material having antithrombogenic properties, and that a considerable amount of heat is generated during high frequency heat treatment, which will be described later. Do.

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 this embodiment, the guide wire 50 is electrically connected to the anode end of the high frequency generator 70, and the electrode shape retainer 30 is electrically connected to the cathode end of the high frequency generator 70. Accordingly, in the present embodiment, as described in the related art, instead of a monopolar electrode using a ground pad, the guide wire 50 and the shape retainer 30 act as positive and negative electrodes, respectively. 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 end of the guide wire 50 and the end of the shape retainer 30. 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 electrode, there is inconvenience in using the ground pad attached to the patient as described above, and above all, it is necessary to close the block by forming a long transmission path of current from the electrode to the ground pad. There was a problem that affects other major vessels or tissues that accompany the blood vessels. However, the use of the bipolar electrode as in the present invention has the advantage of not causing adverse effects on other tissues or blood vessels because a local delivery path is formed only between the guide wire 50 and the shape retainer 30. In addition, in the present invention, there is an advantage that it is very economical by improving the shape retainer 30 used to maintain the shape of the catheter 10 without using a separate electrode core or the like to form a bipolar electrode.

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 shape retainer 30 for electrodes has been described and illustrated as being spirally wound between the inner circumferential surface and the outer circumferential surface of the catheter 10, but is not necessarily limited thereto, and is disposed between the inner circumferential surface and the outer circumferential surface of the catheter to maintain a shape. If it can be, it can be replaced by other configurations. Such a variant embodiment is shown in FIGS. 6 and 7. 6 and 7, members having the same reference numerals as in the above-described embodiment generate the same configuration and effect as in the previous embodiment, and thus will be omitted. Only the shape retaining member which is deformed will be described. do.

Referring to FIG. 6, in this embodiment, the electrode shape retainer 48 is disposed in a mesh shape and inserted between an inner circumferential surface and an outer circumferential surface of the catheter 10. And in the form of a mesh of the core is a form protruding to the outside of the catheter (10).

7, the shape retainer includes an annular support 41 and a linear support 42. The annular support 41 has an annular support formed at a predetermined distance along the longitudinal direction of the catheter 10. In this embodiment, the linear supports 42 are four straight iron cores arranged along the circumferential direction of the annular support 41 along a predetermined angular interval (about 90 degrees), and are arranged long along the longitudinal direction of the catheter 10. do. One end of one of the linear supports 42 is projected relative to the catheter 10 and the other end is connected to the high frequency generator. In addition, the shape retainer may be formed in a straight line in addition to this configuration, one strand or a plurality of strands may be arranged, it is obvious that it can be made in a variety of configurations.

In addition, although the shape retainer 30 has been described as acting on the guide wire 50 by directly acting as an electrode, the present invention is not necessarily limited thereto, and a separate electrode member may be used. An embodiment of this type is shown in FIGS. 8 and 9. 8 is a schematic exploded perspective view for explaining an electrode member applied to another embodiment of the present invention, and FIG. 9 is a schematic cross-sectional view taken along line VII-VII of FIG. 8.

8 and 9, an annular electrode member 80 is fitted to one end of the catheter 10 and coupled thereto. The annular electrode member 80 is made of an electrically conductive material. The shape-retaining member 30 spirally wound between the inner circumferential surface and the outer circumferential surface of the catheter 10 is electrically connected to the electrode member 80. Accordingly, when power is applied, a current transfer path is formed from the guide wire 50 toward the annular electrode member 80. The annular electrode member 80 may be disposed to be spaced a predetermined distance from one end of the catheter 10 toward the other end of the catheter 10 or may be exactly disposed at one end without being spaced apart. However, if the distance is too far apart is not preferable because the current transmission path is too long.

Although the present invention has been described with reference to the embodiments illustrated in the accompanying drawings, this is merely exemplary, and a person of ordinary skill in the art may understand 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.

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, the present invention has the advantage that it is simply configurable and economical by improving the existing shape retainer without additional components to form a bipolar electrode.

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, by temporarily blocking blood vessels using a balloon catheter, even if the blood flow is very fast, there is an advantage that the high-frequency heat treatment can be effectively.

Claims (12)

A hollow catheter inserted into a coronary organ of a living body, the hollow catheter being made of an insulating material and having both ends open and having a lumen coaxially formed therein; Longitudinally disposed along the longitudinal direction of the catheter and inserted between the inner circumferential surface and the outer circumferential surface of the catheter to maintain the shape of the lumen to support the catheter, and both ends protrude from the catheter and exposed to the outside as an electrically conductive material. An electrode shape retainer; And And a guide wire made of an electrically conductive material and coaxially inserted into the lumen so that one end thereof protrudes from the lumen and is spaced apart from the one end of the shape retainer for the electrode by a predetermined distance. The method of claim 1, The shape retainer for the electrode has a spiral shape is wound between the inner peripheral surface and the outer peripheral surface of the catheter, the catheter system. The method of claim 1, The shape retainer for the electrode is a catheter system, characterized in that made of a mesh shape. The method of claim 1, The electrode shape retainer may be arranged in a plurality of annular supports spaced apart from each other along a longitudinal direction of the catheter, and a plurality of annular supports are disposed along a circumferential direction of the annular support, each of which is elongated along a longitudinal direction of the catheter. And a linear support formed and connected to the annular support, wherein both ends of the linear support protrude from the catheter and are exposed to the outside. The method of claim 1, The shape retainer for the electrode is formed long in a linear shape along the longitudinal direction of the catheter is one or more catheter system, characterized in that disposed between the inner and outer peripheral surface of the catheter. The method of claim 1, It further comprises an annular electrode member made of an electrically conductive material and coupled to the outer peripheral surface of one end of the catheter, The shape retainer for the electrode is a catheter system, characterized in that electrically connected to the electrode member. The method of claim 6, The annular electrode member is a catheter system, characterized in that spaced apart a predetermined distance toward the other end from one end of the catheter. The method of claim 1, The length of one end portion of the guide wire protruding from the lumen is 0.5 ~ 2cm, and the central portion between one end and the other end of the guide wire is coated with an insulating material of a polymer material. The method of claim 1, Further comprising a high frequency generator for generating a high frequency current, And the other end of the electrode for maintaining the shape of the electrode and the other end of the guide wire, respectively having different polarities, and are electrically connected to the high frequency generator. The method of claim 1, The lumen is a first lumen formed to penetrate from one end of the catheter to the other end, and is separated from the first lumen by a partition wall, and one end penetrates between an inner circumferential surface and an outer circumferential surface of the catheter and communicates with the outside of the catheter. 2 lumens, The airtight balloon is attached to the outer circumferential surface of the catheter while covering one end of the second lumen, and expands when the fluid is injected through the second lumen, and guides the fluid injected into the balloon to the second lumen of the catheter. And a hollow fluid injection tube having a third lumen connected to the second lumen so as to be formed therein. A hollow catheter inserted into a coronary organ of a living body, the hollow catheter being made of an insulating material and having both ends open and having a lumen coaxially formed therein; And Longitudinally disposed along the longitudinal direction of the catheter body and inserted between the inner circumferential surface and the outer circumferential surface of the catheter to maintain the shape of the lumen to support the catheter body, and both ends protrude from the catheter as an electrically conductive material. And a shape retainer for the electrode exposed to the catheter system. The method of claim 11, It further comprises an annular electrode member made of an electrically conductive material and coupled to the outer peripheral surface of one end of the catheter, And a shape retainer for the electrode that is electrically connected to the electrode member.

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