WO2022259438A1

WO2022259438A1 - Balloon-type electrode catheter

Info

Publication number: WO2022259438A1
Application number: PCT/JP2021/021992
Authority: WO
Inventors: 俊之飯島
Original assignee: 日本ライフライン株式会社
Priority date: 2021-06-09
Filing date: 2021-06-09
Publication date: 2022-12-15
Also published as: JPWO2022259438A1

Abstract

The purpose of the present invention is to provide a balloon-type electrode catheter that does not ablate a vascular site or tissue surrounding the same in contact with a cone portion of a dilated section of the balloon. The balloon-type electrode catheter according to the present invention comprises an outer tube (10), a current-carrying connector (21), a balloon (30) having neck sections (33), (35) at both ends of a dilated section (31), an inner tube (41), a distal-end tip (46), strip electrodes (51)-(54) formed on the outer surface of the balloon (30), a metal ring (60) mounted on the distal-end-side neck section (31), and a lead wire (70). The distal-end portions of each of the strip electrodes (51)-(54) formed on the outer surface of the distal-end-side neck section (33) and a distal-end-side cone portion (313) are insulated and covered by a resin layer (65). FIG. 3A

Description

balloon electrode catheter

The present invention relates to a balloon-type electrode catheter that is introduced intravascularly for high-frequency ablation treatment of a vessel or its surrounding tissue.

Conventionally, as an electrode catheter for high-frequency ablation treatment of a vessel or surrounding tissue, an outer tube having a central lumen and a plurality of sub-lumens arranged around the central lumen, and an outer tube disposed on the proximal end side of the outer tube. a current-carrying connector, an expanding portion that expands and contracts, and neck portions that are continuous to both ends thereof, and the proximal neck portion is fixed to the distal end portion of the outer tube so that the distal end side of the outer tube is connected to the outer tube. and a lumen through which a guide wire can be inserted, is inserted through the central lumen of the outer tube, extends from the opening of the central lumen into the balloon, and extends inside the balloon. and a lumen that communicates with the lumen of the inner tube, is connected to the distal end of the inner tube inside the balloon, is fixed to the distal neck portion, and extends to the outside of the balloon. a surface electrode (belt-shaped electrode) made of a metal thin film formed on the outer surface of the balloon at the expanded portion and the distal neck portion; and attached to the distal neck portion of the balloon, Since the tip of the surface electrode is fixed to the outer peripheral surface thereof, the metal ring electrically connected to the surface electrode and the tip of the metal ring are fixed to the inner peripheral surface of the metal ring so that the inside of the balloon and the a conducting wire extending to any one of the sub-lumens of the outer tube and having its proximal end fixed to the conducting connector to electrically connect the surface electrode and the conducting connector; The applicant of the present invention has proposed a balloon-type electrode catheter (see Patent Document 1 below).

A balloon that constitutes this balloon-type electrode catheter has an expanding portion that expands and contracts, a proximal neck portion that continues to the proximal end of the expanding portion, and a distal neck portion that continues to the distal end of the expanding portion. has a cylindrical portion, a distal cone portion extending from the distal end of the cylindrical portion to the proximal end of the distal neck portion, and a proximal portion extending from the proximal end of the cylindrical portion to the distal end of the proximal neck portion. Consists of a cone portion.

The surface electrodes that make up this balloon-type electrode catheter are formed on the outer surface of the cylindrical portion and the tip-side cone portion of the expansion portion and the tip-side neck portion.

According to this balloon-type electrode catheter, the surface electrode formed on the outer surface of the balloon can be electrically connected to the current-carrying connector via the metal ring and the lead wire. can be energized.

WO2020/35918

When cauterizing a stenosed or occluded vessel or its surrounding tissue using a balloon-type electrode catheter as described in Patent Document 1, a balloon expansion part having a surface electrode formed on its outer surface is used. The cylindrical portion of is brought into contact with the vessel (inner wall) to be treated, and the vessel is cauterized while being dilated.

However, in the balloon-type electrode catheter described in Patent Document 1, surface electrodes are formed not only on the cylindrical portion of the expansion portion, but also on the distal cone portion of the expansion portion and the outer surface of the distal neck portion. Therefore, it is conceivable that the vascular site that is in contact with the distal cone portion or the like is ablated without being sufficiently dilated, resulting in (re)stenosis of the vascular site.

The present invention has been made based on the circumstances as described above.
It is an object of the present invention to perform cauterization treatment on a vessel or its surrounding lesion tissue by means of the cylindrical portion of the expanded portion of the balloon, and to treat the vascular site and its surroundings in contact with the cone portion of the expanded portion. To provide a balloon-type electrode catheter which does not cause surrounding tissue to be cauterized.

(1) The balloon-type electrode catheter of the present invention is a balloon-type electrode catheter that is introduced intravascularly for ablation treatment of a vessel or surrounding tissue,
an outer tube having a central lumen and a plurality of sub-lumens arranged therearound;
a current-carrying connector arranged on the base end side of the outer tube;
It has an extension part consisting of a distal cone part, a cylindrical part and a proximal cone part, and a neck part continuous to both ends of the extension part, and the neck part on the proximal side (base neck part) a balloon connected to the distal end of the outer tube by fixing to the distal end of the outer tube;
an inner tube that has a lumen through which a guide wire can be passed, is inserted through the central lumen of the outer tube, extends from the opening of the central lumen into the balloon, and extends inside the balloon;
It has a lumen that communicates with the lumen of the inner tube, is connected to the distal end of the inner tube inside the balloon, is fixed to the neck portion on the distal end side (distal side neck portion), and is external to the balloon. a distal tip extending into
a metal ring attached to the distal neck or the proximal neck;
The neck portion (the distal side neck portion or the proximal side neck portion) electrically connected to the metal ring and to which the metal ring is attached, the cone portion of the extension portion continuing to the neck portion ( a surface electrode made of a metal thin film formed on the outer surface of the distal cone portion or the proximal cone portion) and the cylindrical portion of the extension;
The tip is fixed to the inner peripheral surface of the metal ring, extends to the sub-lumen of either the inside of the balloon or the outer tube, and the base end is fixed to the current-carrying connector, a conductor for electrically connecting the surface electrode and the conducting connector;
formed on the outer surface of the cone portion (the distal cone portion or the proximal cone portion) continuous with the neck portion (the distal neck portion or the proximal neck portion) to which the metal ring is attached. It is characterized in that the electrode portion that is in contact with the electrode is covered with an insulating coating.

According to the balloon-type electrode catheter having such a configuration, the cylindrical portion of the expanded portion of the balloon can perform cauterization treatment on the vessel or its surrounding lesion tissue, and the neck portion to which the metal ring is attached can be used. Since the electrode portion formed on the cone portion of the extended portion that continues to the , is covered with an insulation, the vicinity of this electrode portion does not become hot during cauterization treatment, and this cone portion (insulation coating layer) does not become hot. It is possible to prevent the vascular site in contact and the surrounding tissue from being ablated, thereby preventing the vascular site from (re)stenosis.

(2) In the balloon electrode catheter of the present invention, the metal ring is attached to the distal neck portion,
the surface electrodes are formed on outer surfaces of the distal neck portion, the distal cone portion of the extension portion, and the cylindrical portion;
It is preferable that the electrode portion formed on the outer surface of the tip-side cone portion is covered with an insulating coating.

According to the balloon-type electrode catheter having such a configuration, since the electrode portion formed on the outer surface of the tip-side cone portion of the extension portion is covered with an insulating coating, the vicinity of this electrode portion is heated during ablation treatment. Therefore, it is possible to prevent the vascular site in contact with the distal cone portion (insulating coating layer) and the tissue around it from being cauterized. ) can prevent stenosis from occurring.

In addition, since the surface electrodes formed on the outer surface of the balloon can be electrically connected to the current-carrying connector via the metal ring and the conducting wire, the high-frequency current can be reliably energized to the surface electrodes.
As a result, cautery treatment can be performed over a wide area on the vessel or the lesion tissue around it.

In addition, the distal side neck portion of the balloon to which the metal ring is attached is the neck portion that is fixed to the distal tip, and has a much smaller outer diameter than the proximal side neck portion that is fixed to the outer tube. The outer diameter of the metal ring attached to the distal neck portion can be made smaller than the outer diameters of the outer tube and the proximal neck portion.
As a result, when the balloon electrode catheter is introduced, the metal ring does not get caught in the sheath used or the opening of the endoscope, and the insertion of the balloon electrode catheter into the lumen of the sheath or endoscope is not damaged.

(3) In the balloon electrode catheter of (2) above, the electrode portions formed on the outer surfaces of the distal neck portion, the distal cone portion of the expanded portion, and the distal end region of the cylindrical portion are covered with an insulating coating. It is preferable that
Here, the “tip region” of the cylindrical portion refers to a region having a certain length including the tip of the cylindrical portion.

According to the balloon-type electrode catheter having such a configuration, the electrode portions formed on the outer surfaces of the tip-side neck portion and the tip-side cone portion of the expansion portion are coated with an insulating material, so that these electrodes can be used during ablation treatment. The vicinity of the electrode portion does not become hot.

Furthermore, in this balloon-type electrode catheter, the electrode portion formed on the outer surface of the distal end region of the cylindrical portion is covered with an insulating coating, so that heat conduction from the distal end region does not increase the temperature of the distal cone portion. can be prevented.
This makes it possible to more effectively prevent cauterization of the vascular site and surrounding tissues in contact with the distal neck portion and the distal cone portion (insulating coating layer) of the extension portion.

In addition, by appropriately adjusting the length of the tip region (insulation coating length), the temperature of the tip region is raised by heat conduction from the region of the cylindrical portion other than the tip region (the region where the electrode portion is not coated with insulation). It is also possible to perform ablation treatment on the vascular site in contact with the tip region or tissue therearound (making the entire cylindrical portion the ablation treatment region).

(4) In the balloon electrode catheter of (3) above, it is preferable that the tip region of the cylindrical portion has a length of 1 to 3 mm.

According to the balloon-type electrode catheter having such a configuration, cauterization of the vascular site and surrounding tissue in contact with the tip-side neck portion and the tip-side cone portion (insulating coating layer) of the expansion portion can be prevented. It can be effectively prevented, and cauterization treatment can be performed by the entire cylindrical portion including the tip region.

(5) In the balloon electrode catheter of (3) or (4) above, it is preferable that the metal ring is covered with an insulating coating.

According to the balloon-type electrode catheter having such a configuration, it is possible to prevent the metal ring from becoming hot during the ablation treatment, and to avoid cauterizing the tissue around the metal ring.

(6) In the balloon electrode catheter of (3) to (5) above, the surface electrode is formed up to the base end position of the cylindrical portion,
It is preferable that the electrode portion formed on the outer surface of the base end region of the cylindrical portion is covered with an insulating coating.
Here, the “proximal end region” of the cylindrical portion refers to a region having a certain length including the proximal end of the cylindrical portion.

According to the balloon-type electrode catheter having such a configuration, since the electrode portion formed in the proximal end region of the cylindrical portion of the expanded portion is covered with an insulating coating, heat from the proximal end region during ablation treatment can be reduced. Conduction can prevent the proximal cone portion from heating up, thereby preventing cauterization of the vascular site and surrounding tissue in contact with the proximal cone portion. can.

In addition, by appropriately adjusting the length of the base end region (insulation coating length), heat conduction from the cylindrical portion other than the base end region (region where the electrode portion is not coated with insulation) can It is also possible to raise the temperature of the proximal end region and ablate the vascular site or surrounding tissue in contact with the proximal end region (making the entire cylindrical portion the ablation treatment region).

(7) In the balloon electrode catheter of (6) above, it is preferable that the proximal region of the cylindrical portion has a length of 1 to 3 mm.

According to the balloon-type electrode catheter having such a configuration, it is possible to more effectively prevent cauterization of the vascular site in contact with the proximal-side cone portion and surrounding tissues, and Ablation treatment can be performed by the entire area of the cylindrical portion including the area.

(8) In the balloon electrode catheter of (2) to (7) above, the surface electrodes are formed to extend along the axial direction of the balloon and are spaced at equal angular intervals along the circumferential direction of the balloon. Each of the strip electrodes is electrically connected to the metal ring by fixing the tip of each of the strip electrodes to the outer peripheral surface of the metal ring. preferably.

According to the balloon electrode catheter having such a configuration, each of the plurality of strip-shaped electrodes formed at equal angular intervals along the circumferential direction of the balloon is electrically connected to the current-carrying connector via the metal ring and the lead wire. Since the electrodes can be directly connected, a high-frequency current can be evenly applied to each of the plurality of strip-shaped electrodes. Homogeneous cautery treatment can be performed.

(9) In the balloon electrode catheter of the present invention, the metal ring is attached to the proximal neck portion,
the surface electrodes are formed on outer surfaces of the proximal neck portion, the proximal cone portion of the extension portion and the cylindrical portion;
It is preferable that the electrode portion formed on the outer surface of the proximal-side cone portion is covered with an insulating coating.

According to the balloon-type electrode catheter having such a configuration, the electrode portion formed on the outer surface of the proximal-side cone portion of the expansion portion is covered with an insulating coating. It is possible to prevent cauterization of the vascular site and surrounding tissues in contact with the proximal cone portion (insulating coating layer) without causing a high temperature, thereby preventing the vascular site from being cauterized. (Re)stenosis can be prevented.

(10) In the balloon electrode catheter of (9) above, the electrode portions are formed on the outer surface of the proximal neck portion, the proximal cone portion of the expansion portion, and the proximal region of the cylindrical portion. is preferably covered with insulation.

According to the balloon-type electrode catheter having such a configuration, the electrode portions formed on the outer surfaces of the proximal-side neck portion and the proximal-side cone portion of the expansion portion are covered with an insulating coating, so that during ablation treatment, The vicinity of these electrode portions does not become hot.

Furthermore, in this balloon-type electrode catheter, the electrode portion formed on the outer surface of the proximal end region of the cylindrical portion is covered with an insulating coating, so that the proximal cone portion rises due to heat conduction from the proximal end region. warming can be prevented.
As a result, it is possible to more effectively prevent cauterization of the vascular site and surrounding tissues that are in contact with the proximal-side neck portion and the proximal-side cone portion (insulating coating layer) of the extension portion. .

(11) In the balloon electrode catheter of (10) above, it is preferable that the proximal region of the cylindrical portion has a length of 1 to 3 mm.

According to the balloon-type electrode catheter having such a configuration, the vascular site and surrounding tissues in contact with the proximal-side neck portion and the proximal-side cone portion (insulating coating layer) of the expansion portion are cauterized. can be more effectively prevented, and cauterization treatment can be performed using the entire cylindrical portion including the proximal region.

(12) In the balloon electrode catheter of (10) or (11) above, it is preferable that the metal ring is covered with an insulating coating.

(13) In the balloon electrode catheter of (10) to (12) above, the surface electrode is formed up to the tip position of the cylindrical portion,
It is preferable that the electrode portion formed on the outer surface of the tip region of the cylindrical portion is covered with an insulating coating.

According to the balloon-type electrode catheter having such a configuration, since the electrode portion formed in the tip region of the cylindrical portion of the expansion portion is covered with an insulating coating, heat conduction from the tip region during cauterization treatment It is possible to prevent the distal cone portion from heating up, thereby preventing cauterization of the vascular site and surrounding tissue in contact with the distal cone portion.

(14) In the balloon electrode catheter of (13) above, it is preferable that the tip region of the cylindrical portion has a length of 1 to 3 mm.

According to the balloon-type electrode catheter having such a configuration, it is possible to more effectively prevent cauterization of the vascular site and surrounding tissue in contact with the tip-side cone portion, and to prevent the tip region from being cauterized. Ablation treatment can be performed by the entire area of the cylindrical portion including.

(15) In the balloon electrode catheter of (9) to (14) above, the surface electrodes are formed to extend along the axial direction of the balloon, and are spaced at equal angular intervals along the circumferential direction of the balloon. Each of the strip electrodes is electrically connected to the metal ring by fixing the proximal end of each of the strip electrodes to the outer peripheral surface of the metal ring. preferably.

According to the balloon electrode catheter of the present invention, the cylindrical portion of the expanded portion of the balloon can perform ablation treatment on the vessel or the lesion tissue around it, and is in contact with the cone portion of the expanded portion. It is possible to prevent the vascular site and surrounding tissue from being cauterized.

1 is a plan view of a balloon-type electrode catheter according to a first embodiment of the present invention; FIG. FIG. 2 is a partially broken front view of the balloon electrode catheter shown in FIG. 1 (a front view including the II-II cross section in FIG. 1); FIG. 2 is a perspective view showing the tip portion of the balloon-type electrode catheter shown in FIG. 1; FIG. 2 is a front view schematically showing the tip portion of the balloon electrode catheter shown in FIG. 1; 2 is a perspective view showing the tip portion (the tip side of the balloon) of the balloon-type electrode catheter shown in FIG. 1. FIG. 2 is a perspective view showing the distal end portion (the proximal end side of the balloon) of the balloon electrode catheter shown in FIG. 1. FIG. FIG. 3 is a partially enlarged view (detailed view of VI section) of FIG. 2 ; FIG. 7 is a partially enlarged view (detailed view of VII section) of FIG. 6 ; FIG. 3 is a partially enlarged view (detailed view of section VIII) of FIG. 2; FIG. 2 is a cross-sectional view taken along line IX-IX of FIG. 1; FIG. 10 is a partially enlarged view (detailed view of X section) of FIG. 9; 2 is a cross-sectional view taken along line XI-XI of FIG. 1; FIG. FIG. 2 is a cross-sectional view taken along line XII-XII in FIG. 1; FIG. 13 is a partially enlarged view (detailed view of section XIII) of FIG. 12; FIG. 2 is a cross-sectional view taken along line XIV-XIV of FIG. 1; FIG. 2 is a cross-sectional view taken along line XV-XV of FIG. 1; FIG. 16 is a partially enlarged view (detailed view of XVI section) of FIG. 15; FIG. 2 is a cross-sectional view taken along line XVII-XVII of FIG. 1; FIG. 18 is a partially enlarged view (detailed view of section XVIII) of FIG. 17; 2 is a cross-sectional view taken along line XIX-XIX of FIG. 1; FIG. 20 is a partially enlarged view (detailed view of XX section) of FIG. 19; FIG. 2 is a cross-sectional view taken along line XXI-XXI of FIG. 1; FIG. FIG. 22 is a partially enlarged view (detailed view of XXII section) of FIG. 21; 2 is a cross-sectional view taken along line XXIII-XXIII of FIG. 1; FIG. 2 is a cross-sectional view taken along line XXIV-XXIV of FIG. 1; FIG. FIG. 10 is a front view schematically showing a tip portion of a balloon-type electrode catheter according to a second embodiment of the present invention; FIG. 11 is a front view schematically showing the distal end portion of a balloon-type electrode catheter according to a third embodiment of the present invention; FIG. 11 is a front view schematically showing a tip portion of a balloon-type electrode catheter according to a fourth embodiment of the present invention;

<First Embodiment>
The balloon-type electrode catheter 100 of this embodiment is a balloon-type electrode catheter that is introduced intravascularly and is used to treat a lesion tissue such as a tumor in or around a vessel by high-frequency ablation.

The balloon-type electrode catheter 100 shown in FIGS. 1 to 24 consists of a circular tubular portion 11 and a semi-circular tubular portion 13, and an outer tube having a central lumen 10L and sub-lumens 101L to 112L arranged therearound. 10; an electrical connector 21 disposed on the proximal side of the outer tube 10; an extension portion 31 that expands and contracts, comprising a distal cone portion 313, a cylindrical portion 311, and a proximal cone portion 315; and a neck portion (distal side neck portion 33 and proximal side neck portion 35) continuous to both ends of the outer tube 10, and the proximal side neck portion 35 is fixed to the circular tubular portion 11 constituting the distal portion of the outer tube 10, A balloon 30 connected to the distal end side of the outer tube 10 by enclosing the semicircular tubular portion 13 forming the distal end portion of the outer tube 10 in the expansion portion 31; an inner tube 41 inserted through the central lumen 10L, extending from the opening of the central lumen 10L into the balloon 30 and extending inside the balloon 30; a distal tip 46 that has a wire lumen), is connected to the distal end of the inner tube 41 inside the balloon 30, is fixed to the distal neck portion 33, and extends to the outside of the balloon 30; strip electrodes 51 to 54 (surface electrodes) made of thin metal films formed on the outer surfaces of the neck portion 33, the distal cone portion 313 of the expansion portion 31, and the cylindrical portion 311; , a metal ring 60 electrically connected to each of the strip electrodes 51 to 54 by fixing the tips of the strip electrodes 51 to 54 to the outer peripheral surface thereof; a conducting wire 70 connected at its distal end and extending to the interior of the balloon 30 and the sub-lumen 112L of the outer tube 10 (circular tubular portion 11), and having its proximal end connected to the electrical connector 21; The distal end (temperature measuring portion 81) is embedded in the tube wall of the electrical connector 21 and extends to the tube walls of the expansion portion 31 and the proximal neck portion 35 and the lumen 106L of the outer tube 10 (cylindrical portion 11). and a temperature sensor (thermocouple) 80 whose proximal end is connected to; the outer peripheral surface of the metal ring 60, each of the strip electrodes 51 to 54 fixed to the outer peripheral surface of the metal ring 60 each of the strip electrodes 51 to 54 formed on the outer surface of the distal neck portion 33; and each of the strip electrodes 51 to 54 formed on the outer surface of the distal cone portion 313 of the extension portion 31. and the electrode portions of each of the strip electrodes 51 to 54 formed on the outer surface of the tip region 3113 of the cylindrical portion 311 are covered with a resin layer 65 for insulation.
1 and 2, 20 is a Y connector connected to the proximal end of the

outer tube

10, 22 is a fluid supply connector, 23 is a fluid discharge connector, 24 is a guide wire connector, 26 is a wire protection tube, 27 is a fluid supply tube, and 28 is a fluid discharge tube.

As shown in FIGS. 3A, 4, 5, 14, 15, and 17 to 22, the outer tube 10 constituting the balloon electrode catheter 100 is composed of a circular tubular portion 11 and a semi-circular tubular portion 13. Become.
A portion of the base end portion and the distal end portion of the outer tube 10 is composed of a circular tubular portion 11 , and the distal end portion of the outer tube 10 (excluding the aforementioned portion) is composed of a semi-circular tubular portion 13 .

As shown in FIGS. 17, 19 and 21, inside the circular tubular portion 11 of the outer tube 10, there are a

central lumen

10L and 12 sub-lumens arranged at equiangular (30°) intervals around the central lumen 10L. 101L to 112L are formed.
In the circular tubular portion 11, each of the sub-lumens 101L to 112L is formed by a lumen tube surrounding it, and these lumen tubes are fixed by the binder resin that forms the circular tubular portion 11. As shown in FIG.

As shown in FIGS. 14 and 15, sub-lumens 101L to 105L are formed continuously from the inside of the circular tubular portion 11 inside the semicircular tubular portion 13 of the outer tube 10 .
A lumen tube surrounding each of the sub-lumens 101L to 105L in the semicircular tubular portion 13 is fixed by a binder resin that forms the semicircular tubular portion 13 .

As shown in FIGS. 3A and 4, the sub-lumens 101L to 105L arranged inside the circular tubular portion 11 and inside the semi-circular tubular portion 13 are respectively located in the semi-circular tubular portion which is the distal end surface of the outer tube 10. 13 is open at the tip surface 14 thereof.

Each of the sub-lumens 101L-105L communicates with the fluid supply connector 22 shown in FIGS.
As a result, the sub-lumens 101L to 105L (5 sub-lumens out of 12 sub-lumens formed in the outer tube 10) are used to supply fluid to the inside of the balloon 30 (expansion portion 31). fluid supply sub-lumen”.
Here, physiological saline can be exemplified as the fluid supplied inside the balloon 30 .

As shown in FIGS. 3A and 5, central lumen 10L and sub-lumens 106L to 112L formed inside circular tubular portion 11 open at distal end surface 12 of circular tubular portion 11, respectively.
However, the openings of the sub-lumens 106L, 110L and 112L are sealed with a sealing material 90 shown in FIG.

Each of the sub-lumens 107L-111L communicates with the fluid discharge connector 23 shown in FIG.
As a result, the sub-lumens 107L to 109L and 111L (four sub-lumens out of twelve sub-lumens formed in the outer tube 10) allow the fluid supplied inside the balloon 30 (expansion portion 31) to flow. It becomes a “fluid discharge sub-lumen” for discharging from the inside of the balloon 30 .

The constituent material of the outer tube 10 is not particularly limited, but examples thereof include polyamide-based resins such as polyamide, polyether polyamide, polyether block amide (PEBAX (registered trademark)), and nylon. Of these, PEBAX is preferred.

The outer diameter of the outer tube 10 (the outer diameter at the base end portion, which will be described later) is usually 1.0 to 3.3 mm, and a preferred example is 1.45 mm.
The diameter of the central lumen 10L of the outer tube 10 is usually 0.35 to 0.95 mm, preferably 0.85 mm.
The diameter of the sub-lumens 101L to 112L of the outer tube 10 is normally 0.10 to 0.75 mm, and a preferred example is 0.25 mm.
The length of the outer tube 10 is usually 100-2200 mm, and a preferred example is 1800 mm.

As shown in FIGS. 1 and 2, a Y connector 20 is connected to the proximal end of the outer tube 10 .
As shown in FIG. 23, the lumen tube surrounding the sub-lumens 101L to 105L and the sub-lumens 107L to 111L of the outer tube 10 enters the inside of the Y connector 20 from the proximal end of the outer tube 10. As shown in FIG.

As shown in FIG. 24, the base end of the lumen tube surrounding the sub-lumens 101L to 105L (fluid supply sub-lumens) is connected (bonded) to the fluid supply tube 27 having a single lumen structure inside the Y connector 20. (fixed by agent 95).
The fluid supply tube 27 extends outside the Y connector 20 , and the proximal end of the fluid supply tube 27 is connected to the fluid supply connector 22 .

The proximal end of the lumen tube surrounding the sub-lumens 107L to 111L is connected (fixed with an adhesive 95) to the fluid discharge tube 28 having a single lumen structure inside the Y connector 20. As shown in FIG.
The fluid discharge tube 28 extends outside the Y connector 20 , and the proximal end of the fluid discharge tube 28 is connected to the fluid discharge connector 23 .

The balloon 30 that constitutes the balloon-type electrode catheter 100 includes an expansion portion 31 that expands and contracts, a distal neck portion 33 that continues to the distal end of the expansion portion 31 (distal cone portion 313), and an expansion portion 31 (proximal cone portion 313). 315) and a proximal side neck portion 35 that continues to the proximal end of the portion 315).

The expanded portion 31 of the balloon 30 is a space-forming portion that expands when fluid is supplied to its interior and contracts when the fluid is discharged from its interior.
As shown in FIGS. 1-5, the expansion portion 31 of the balloon 30 includes a cylindrical portion 311, a distal cone portion 313 extending from the distal end of the cylindrical portion 311 to the proximal end of the distal neck portion 33, and a cylindrical portion. and a proximal cone portion 315 extending from the proximal end of portion 311 to the distal end of proximal neck portion 35 .

The proximal neck portion 35 is fixed to the distal end portion of the outer tube 10 (the distal end portion formed by the circular tubular portion 11), and the distal end portion of the outer tube 10 (the distal end portion formed by the semi-circular tubular portion 13). , the balloon 30 is connected to the distal end side of the outer tube 10 .

Here, the distal end portion (circular tubular portion 11 shown in FIG. 19) of the outer tube 10 to which the proximal neck portion 35 of the balloon 30 is fixed has its surface layer portion shaved off, and its outer diameter is equal to that of the proximal end. The outer diameter is smaller than the outer diameter of the proximal end portion (circular tubular portion 11 shown in FIG. 21) of the outer tube 10 to which the side neck portion 35 is not fixed.
19 is substantially equal to the outer diameter of the proximal end portion of the outer tube 10 shown in FIG.

Accordingly, it is possible to prevent impairing the insertability of a sheath or an endoscope used for introducing the balloon electrode catheter 100 into the lumen of the proximal neck portion 35 .
In addition, since the outer diameter of the outer tube 10 can be set to the maximum diameter limited by the sheath or the endoscope (there is no need to consider the expansion of the outer diameter due to the thickness of the proximal neck portion), the outer tube 10 can be A sufficient diameter of the sub-lumens 101L to 112L can be secured, and the cooling effect inside the balloon 30 can be further improved.

As shown in FIGS. 3A and 4, the distal end surface 14 of the semi-circular tubular portion 13 through which the fluid supply sub-lumens 101L to 105L are opened is on the distal side of the intermediate position in the axial direction of the expanded portion 31 of the balloon 30. It is located near the tip of the cylindrical portion 311 .
As a result, the fluid flowing through the fluid supply sub-lumens 101L to 105L is discharged in the distal direction from each opening positioned near the distal end of the cylindrical portion 311, and the discharged fluid is transferred to the expanded portion 31 (the distal cone). It is possible to reach the vicinity of the distal end of the portion 313), thereby forming a fluid flow from the distal side to the proximal side inside the balloon 30 (extended portion 31).

When the opening position of the fluid supply sub-lumen is on the proximal side of the intermediate position in the axial direction of the expanded portion of the balloon, even if the fluid is discharged in the distal direction from the opening after the balloon is expanded, The fluid cannot reach the vicinity of the distal end of the balloon, and a flow of the fluid from the distal end side to the proximal end side cannot be formed inside the balloon.

As shown in FIGS. 3A and 5, the distal end surface 12 of the circular tubular portion 11 through which the fluid discharge sub-lumens 107L to 109L and 111L are opened is located at the proximal end of the expanded portion 31. As shown in FIG.

The constituent material of the balloon 30 is not particularly limited, and the same materials as the balloon constituting the conventionally known balloon catheter can be used. For example, polyamide such as polyamide, polyether polyamide, PEBAX and nylon Polyurethane resins such as thermoplastic polyether urethane, polyether polyurethane urea, fluorine polyether urethane urea, polyether polyurethane urea resin and polyether polyurethane ureaamide.

The diameter of the balloon 30 (expansion portion 31) is normally 0.7 to 30.0 mm, and a preferred example is 2.0 mm.
The outer diameter of the proximal neck portion 35 of the balloon 30 is substantially equal to the outer diameter of the proximal end portion of the outer tube 10, and is usually 1.0 to 3.3 mm, and a preferred example is 1.45 mm. is.
The length of the expanded portion 31 of the balloon 30 is normally 11 to 70 mm, and a preferred example is 30 mm.
The length of the cylindrical portion 311 of the extended portion 31 is normally 5 to 50 mm, and a preferred example is 20 mm.
The lengths of the distal cone portion 313 and the proximal cone portion 315 of the extended portion 31 are usually 3 to 10 mm, and a preferred example is 5 mm.

In the balloon electrode catheter 100 of this embodiment, the inner tube 41 and the distal tip 46 constitute an inner shaft.
The inner tube 41 constituting the balloon-type electrode catheter 100 has a lumen through which a guidewire can be inserted (guidewire lumen), is inserted through the central lumen 10L of the outer tube 10 (circular tubular portion 11), and has a distal end. It extends from the opening of the central lumen 10L to the inside of the balloon 30 (expansion portion 31).

The distal end portion of the inner tube 41 extending inside the balloon 30 (expansion portion 31) is covered with the semi-circular tubular portion 13 on the half circumference portion of the outer peripheral surface thereof, and extends into the proximal end cone portion 315 of the expansion portion 31. , cylindrical portion 311 and distal cone portion 313 , and is connected to distal tip 46 inside distal cone portion 313 .

On the other hand, as shown in FIGS. 23 and 24, the proximal end of the inner tube 41 enters the Y connector 20 from the proximal end of the outer tube 10 (the opening on the proximal side of the central lumen 10L), 20 and extends outside the Y connector 20 , and the proximal end of the inner tube 41 is connected to the guide wire connector 24 .

As the material for forming the inner tube 41, the same material as the inner tube constituting a conventionally known balloon catheter can be used. ketone resins) are preferred.

The outer diameter of the inner tube 41 is the same as or slightly smaller than the diameter of the central lumen 10L of the outer tube 10 through which it is inserted, and is usually 0.34 to 0.99 mm, and a preferred example is 0.84 mm. It is said that
The inner diameter of the inner tube 41 is normally 0.31 to 0.92 mm, preferably 0.68 mm.

The distal tip 46 that constitutes the balloon-type electrode catheter 100 has a lumen (guidewire lumen) that communicates with the guidewire lumen of the inner tube 41 , and the inner tube inside the distal cone portion 313 of the expanded portion 31 of the balloon 30 . 41 , is fixed to the distal neck portion 33 and extends to the outside of the balloon 30 . The tip of the distal tip 46 is open.

The constituent material of the distal tip 46 is not particularly limited, but examples include polyamide resins such as polyamide, polyether polyamide, PEBAX and nylon, and polyurethane.

The inner diameter of the distal tip 46 is substantially the same as the inner diameter of the inner tube 41 and is normally zero.
. It is 31 to 0.92 mm, and a preferred example is 0.68 mm.
The outer diameter of the distal tip 46 is normally 0.35 to 2.6 mm, and a preferred example is 1.0 mm.
The outer diameter of the distal neck portion 33 of the balloon 30 to which the distal tip 46 is fixed is usually 0.37 to 3.3 mm, and a preferred example is 1.18 mm.

As shown in FIGS. 3A, 3B, 4-7, and 9-15, the outer surface of balloon 30 (distal neck 33, distal cone portion 313 and cylindrical portion 311 of extension 31) has As surface electrodes to which a high-frequency current is applied, strip electrodes 51 to 54 formed of metal thin films extending along the axial direction of the balloon 30 are arranged at intervals of 90° along the circumferential direction of the balloon 30. ing.

Examples of materials for forming the thin metal films forming the strip electrodes 51 to 54 include gold, platinum, silver, copper, alloys thereof, and stainless steel.
The film thickness of the thin metal films forming the strip electrodes 51 to 54 is preferably 0.5 to 5.0 μm, more preferably 1.0 to 2.5 μm.
If this film thickness is too small, the temperature of the metal thin film may rise to a high temperature due to Joule heat during the procedure (during high-frequency current application).
On the other hand, if the film thickness of the thin film is too large, the metal thin film will be less likely to follow the change in shape of the balloon that accompanies expansion and contraction, which may impair the expansion/contraction properties of the balloon.

The method of forming the metal thin films constituting the strip electrodes 51 to 54 on the outer surface of the balloon 30 is not particularly limited, and ordinary metal thin film forming methods such as vapor deposition, sputtering, plating, and printing can be employed. can.

As shown in FIGS. 3A, 3B, 4, 6, 9 and 10, a metal ring 60 is attached to the distal neck portion 33 of the balloon 30. A metal ring 60 that constitutes the balloon electrode catheter 100 is crimped and fixed to the distal neck portion 33 . The tip of each of the strip electrodes 51 to 54 is fixed (contacted) to the outer peripheral surface of the metal ring 60 . Thereby, each of the strip electrodes 51 to 54 and the metal ring 60 are electrically connected.

Examples of the constituent material of the metal ring 60 include platinum and platinum-based alloys.

The inner diameter of the metal ring 60 attached to the distal neck portion 33 is substantially the same as the outer diameter of the distal neck portion 33, and is usually 0.37 to 3.3 mm. .18 mm.
The outer diameter of the metal ring 60 attached to the distal neck portion 33 is smaller than the outer diameters of the outer tube 10 and the proximal neck portion 35, and is usually 0.98 to 3.28 mm. is 1.32 mm.

As shown in FIGS. 3A, 3B, 4, 6, 7, and 9-13, the outer peripheral surface of the metal ring 60 (excluding the surface area where the strip electrodes 51-54 are fixed), the metal ring 60, the electrode portions of the strip electrodes 51 to 54 formed on the outer surface of the distal neck portion 33, and the distal end side of the extension portion 31. The electrode portions of each of the strip electrodes 51 to 54 formed on the outer surface of the cone portion 313 and the electrode portions of each of the strip electrodes 51 to 54 formed on the outer surface of the tip region 3113 of the cylindrical portion 311 are It is insulated and covered with a resin layer 65 (indicated by halftone dots in FIGS. 3A and 4).

Since the electrode portions formed on the outer surfaces of the tip-side neck portion 33 and the tip-side cone portion 313 of the extension portion 31 are coated with insulation, even if each of the strip-shaped electrodes 51 to 54 is energized, the metal ring 60 , the electrode portion formed on the outer surface of the tip-side neck portion 33, and the electrode portion formed on the outer surface of the tip-side cone portion 313 of the extension portion 31. It never gets hot.

Furthermore, in this balloon-type electrode catheter 100, the electrode portion formed on the outer surface of the distal end region 3113 of the cylindrical portion 311 is covered with an insulating coating, so that heat conduction from the distal end region 3113 causes the distal cone portion 313 to temperature rise can be prevented.
As a result, the distal neck portion 33 and the distal cone portion 313 of the extension portion 31 do not reach the ablation temperature, and the vascular site and its surroundings in contact with the distal neck portion 33 and the distal cone portion 313 are prevented from reaching the ablation temperature. tissue can be prevented from being ablated.

In addition, by appropriately adjusting the length of the tip region 3113 (the region where the resin layer 65 is formed in the cylindrical portion 311), the region of the cylindrical portion 311 other than the tip region 3113 (the region where the electrode portion is not covered with insulation) The temperature of the tip region 3113 is increased by heat conduction from the tip region 3113, and the vascular site in contact with the tip region 3113 or the surrounding tissue is cauterized (the entire cylindrical portion 311 is treated as the cautery treatment region). is also possible.

The length of the tip region 3113 of the cylindrical portion 311 forming the resin layer 65 is normally 1 to 3 mm, preferably 2 mm.
By setting the length of the tip region 3113 to 1 mm or more (the electrode portion of each of the strip electrodes 51 to 54 formed in the tip region 3113 is insulated and coated with the resin layer 65), each of the strip electrodes 51 to 54 Even if a high-frequency current is applied to the tip end cone portion 313 due to heat conduction, it is possible to prevent the tip end cone portion 313 from becoming hot.

Also, by setting the length of the tip region 3113 to 3 mm or less, the tip region 3113 can be heated to a temperature at which cauterization is possible, and the entire cylindrical portion 311 including the tip region 3113 can be used for cauterization treatment.

As a mode for insulating and covering the outer peripheral surface of the metal ring 60 and the electrode portions of the strip electrodes 51 to 54, the tip side neck portion 33 is covered so as to cover the electrode portions of the metal ring 60 and the strip electrodes 51 to 54. A mode in which the resin layer 65 is formed on the outer surface, the distal end cone portion 313 and the outer surface of the distal end region 3113 of the cylindrical portion 311 can be mentioned.

The resin constituting the resin layer 65 is not particularly limited as long as it is an insulating resin having good adhesion to the balloon 30. For example, the resins exemplified as the constituent material of the balloon 30 can be used. Among these, polyurethane-based resins and the like are preferable.

The method of forming the resin layer 65 is not particularly limited, either. For example, a method of applying the resin for forming the resin layer to the region to be insulated by spraying or the like, and drying and curing the coating film can be mentioned. can be done.

A leading end of a conducting wire 70 is fixed to the inner peripheral surface of the metal ring 60 .
This lead 70 extends into the vessel wall of distal tip 46, as shown in FIGS. 9 and 11, and along inner tube 41, as shown in FIGS. 17, 19 and 21, extends into the sub-lumen 112L of the outer tube 10 (circular tubular portion 11), and as shown in FIGS. 23 and 24, It extends inside the Y connector 20 and extends from the Y connector 20 through the inside of a conductor protection tube 26 extending from the Y connector 20 .

The base end of the conducting wire 70 is connected to the electrical connector 21 . The electrical connector 21 has both a function as a connector for conducting a high-frequency current to each of the strip electrodes 51 to 54 and a function as a thermocouple connector for connecting the temperature sensor 80 to a temperature measuring instrument. .

By connecting each of the strip electrodes 51 to 54 to the electrical connector 21 via the metal ring 60 and the lead wire 70, a high frequency current can be applied to each of the strip electrodes 51 to 54 evenly.

Examples of the constituent material of the conducting wire 70 include copper, silver, gold, platinum, tungsten, and alloys of these metals, and it is preferable that an electrically insulating protective coating such as fluororesin is applied.

As shown in FIGS. 3, 5, and 15 to 20, a temperature sensor 80 consisting of a thermocouple is embedded in the tube wall of the balloon 30. As shown in FIG. A side temperature portion 81 (temperature measuring junction) of the temperature sensor 80 is located on the pipe wall of the extension portion 31 .

As shown in FIGS. 19 to 22, the temperature sensor 80 enters the sub-lumen 106L of the outer tube 10 (cylindrical portion 11) from the tube wall of the proximal neck portion 35 of the balloon 30 and enters the sub-lumen 106L. 23 and 24, extends inside the Y connector 20 together with the conductor 70 and extends from the Y connector 20 through the inside of the conductor protection tube 26 extending from the Y connector 20. ing.
A proximal end of the temperature sensor 80 is connected to the electrical connector 21 .

According to the balloon-type electrode catheter 100 of this embodiment, the cylindrical portion 311 of the expanded portion 31 of the balloon 30 can perform cauterization treatment on a vessel or lesion tissue therearound.
In addition, since the electrode portions of each of the strip electrodes 51 to 54 formed on the outer surfaces of the tip-side neck portion 33 and the tip-side cone portion 313 of the extension portion 31 are insulated and coated with the resin layer 65, they are , the vicinity of these electrode portions does not reach a high temperature.
Furthermore, since the electrode portions of the strip electrodes 51 to 54 formed on the outer surface of the tip region 3113 of the cylindrical portion 311 are insulated, the temperature of the tip cone portion 313 rises due to heat conduction from the tip region 3113. can be prevented.
As a result, it is possible to prevent cauterization of the vascular site and surrounding tissues in contact with the distal neck portion 33 and the distal cone portion 313 of the expansion section 31, and the vascular site (recurrent ) can prevent stenosis from occurring.

In addition, the metal ring 60 is attached to the distal neck portion of the balloon 30, and the distal end portions of the strip electrodes 51 to 54 are fixed to the outer peripheral surface of the metal ring 60, so that each of the strip electrodes 51 to 54 , are electrically connected to the electrical connector 21 via the metal ring 60 and the lead wire 70, so that a high-frequency current can be applied equally to each of the strip-shaped electrodes 51 to 54. Alternatively, the lesion tissue around it can be uniformly cauterized along the circumferential direction of the vessel.

In addition, since the outer diameter of the metal ring 60 attached to the distal neck portion 33 of the balloon 30 is smaller than the outer diameters of the outer tube 10 and the proximal neck portion 35, the sheath or endoscope used at the time of introduction can be used. The metal ring 60 does not get caught in the opening of the endoscope, and the insertability of the balloon-type electrode catheter 100 into the lumen of the sheath or endoscope is not impaired.

Further, each of the fluid supply sub-lumens 101L to 105L opens at the distal end surface 14 of the semicircular tubular portion 13 located near the distal end of the cylindrical portion 311 of the expanded portion 31 of the balloon 30, and the fluid discharge sub-lumen 107L. Each of 109L and 111L is open at the distal end surface 12 of the circular tubular portion 11 located at the proximal end of the expanded portion 31 of the balloon 30, so that after expansion of the balloon 30 (after the inside is filled with fluid) ), a fluid flow can be formed from the distal side to the proximal side inside the balloon 30, and the fluid can be made to flow.

In particular, the fluid discharged in the distal direction from the openings of the fluid supply sub-lumens 101L to 105L hits the inner wall surface of the distal cone portion 313 of the extension portion 31, and then hits the cylindrical portion 311 and the proximal end of the extension portion 31. By flowing proximally along the inner wall surface of the side cone portion 315, the fluid can be circulated inside the balloon 30 (extended portion 31).

As a result, the inside of the balloon 30 can be efficiently cooled over the entire area of the expanded portion 31, thereby sufficiently cooling the tissue around the strip electrodes 51 to 54, thereby preventing the tissue from fibrosis. can be reliably prevented.

Further, since there are five fluid supply sub-lumens 101L to 105L and four fluid discharge sub-lumens 107L to 109L and 111L arranged in the outer tube 10, the inside of the balloon 30 is kept under a constant pressure (expanded). pressure).

Cases to which the balloon-type electrode catheter 100 of the present embodiment can be applied include tumors and vagus nerves in and around blood vessels, specifically bile duct cancer, lung cancer, liver cancer, kidney cancer, and adrenal adenoma. , renal artery vagus nerve, and the like.

<Second embodiment>
A balloon-type electrode catheter 200 of this embodiment having a distal end portion shown in FIG. , each electrode portion of the strip electrodes 51 to 54 formed on the outer surface of the distal neck portion 33, the strip electrode 51 formed on the outer surface of the distal cone portion 313 of the extension portion 31 to 54 and each of the strip electrodes 51 to 54 formed on the outer surface of the tip region 3113 of the cylindrical portion 311 are covered with a resin layer 65 for insulation. In FIG. 25, the strip electrodes 54 arranged to face the strip electrodes 52 are not shown.

In the balloon electrode catheter 200 of the present embodiment, each electrode portion of the strip electrodes 51 to 54 formed on the outer surface of the proximal end region 3115 of the cylindrical portion 311 is insulated and coated with the resin layer 66. This is different from the electrode catheter 100 of the first embodiment.

As a mode for insulating and covering the electrode portions of each of the strip electrodes 51 to 54 formed on the outer surface of the base end region 3115 of the cylindrical portion 311, the outer surface of the base end region 3115 is covered so as to cover these electrode portions. A mode in which a resin layer 66 is formed on the surface can be mentioned.

As the resin forming the resin layer 66, the same resin as the resin forming the resin layer 65 can be used. As a method of forming the resin layer 66, the same method of forming the resin layer 65 can be used.

The length of the base end region 3115 of the cylindrical portion 311 forming the resin layer 66 is normally 1 to 3 mm, preferably 2 mm.
By setting the length of the base end region 3115 to 1 mm or longer (each electrode portion of the strip electrodes 51 to 54 formed in the base end region 3115 is covered with an insulating resin layer 66), the strip electrodes 51 to 54 Even if a high-frequency current is applied to each of , it is possible to prevent the proximal end cone portion 315 from becoming hot due to heat conduction.
In addition, by setting the length of the base end region 3115 to 3 mm or less, the base end region 3115 can be displaced by heat conduction from the region of the cylindrical portion 311 other than the base end region 3115 (region where the electrode portion is not covered with insulation). The temperature is raised to a temperature at which cauterization is possible, and cauterization treatment can be performed using the entire cylindrical portion 311 including the proximal end region 3115 .
The strip electrodes 51 to 54 constituting the balloon electrode catheter 200 of the present embodiment are formed up to the base end position of the cylindrical portion 311 (the same applies to the balloon electrode catheter 100 of the first embodiment). .
According to such a configuration, for example, when the balloon 30 is extended from the forceps port of the endoscope, by grasping the base end positions of the strip electrodes 51 to 54 from the image captured by the endoscope, The proximal end of cylindrical portion 311 (ie, the proximal position of the ablation treatable portion) can be known.

According to the balloon-type electrode catheter 200 of this embodiment, the same effects as those of the balloon-type electrode catheter 100 of the first embodiment can be obtained.
In addition, since the electrode portions of the strip electrodes 51 to 54 formed on the outer surface of the base end region 3115 of the cylindrical portion 311 of the extension portion 31 are insulated and coated with the resin layer 66, the base end portion can be Heat conduction from end region 3115 can prevent proximal cone portion 315 from heating up, thereby ablating the vascular site and surrounding tissue in contact with proximal cone portion 315 . can be prevented.
Further, by appropriately adjusting the length of the base end region 3115, the temperature of the base end region 3115 is raised by heat conduction from the region of the cylindrical portion 311 other than the base end region 3115, and the base end region 3115 is brought into contact with the base end region 3115. It is possible to perform ablation treatment on the vascular site where the patient is located or the tissue around it (the entire cylindrical portion 311 is set as the ablation treatment area).

<Third Embodiment>
A balloon-type electrode catheter 300 of this embodiment having a distal end portion shown in FIG. The strip electrodes 51 to 54 are attached to the proximal end neck portion 35 of the balloon 30, and the proximal end portions of the strip electrodes 51 to 54 are fixed to the outer peripheral surfaces of the strip electrodes 51 to 54. a metal ring 60 electrically connected to each of the metal rings 60, a conducting wire having its tip end connected to the inner peripheral surface of the metal ring 60 and its base end connected to an electrical connector, and a temperature sensor. The outer peripheral surface of the ring 60, the electrode portions of each of the strip electrodes 51 to 54 fixed to the outer peripheral surface of the metal ring 60, and the electrode portions of each of the strip electrodes 51 to 54 formed on the outer surface of the proximal neck portion 35. The electrode portion, the electrode portion of each of the strip electrodes 51 to 54 formed on the outer surface of the proximal end cone portion 315 of the extension portion 31, and the outer surface of the proximal end region 3115 of the cylindrical portion 311 are formed. Each electrode portion of the strip electrodes 51 to 54 is covered with a resin layer 67 for insulation.

In the balloon electrode catheter 300, the electrical connector, the inner tube, the lead wire and the temperature sensor, which are not shown in FIG. Similar to temperature sensor 80 . FIG. 26 does not show the strip electrodes 54 arranged opposite to the strip electrodes 52 .

The balloon-type electrode catheter 300 of this embodiment differs from the balloon-type electrode catheter 100 of the first embodiment in that the metal ring 60 constituting this is attached to the proximal-side neck portion 35 of the balloon 30. there is As a result, the base end portions of the strip electrodes 51 to 54 are fixed to the outer peripheral surface of the metal ring 60, and the base end neck portion 35 of the balloon 30, the base end cone portion 315 of the extension portion 31, and the cylindrical portion of the expansion portion 31 are secured to each other. 311 on the outer surface of the proximal neck portion 3
5. The electrode portions formed on the outer surfaces of the proximal end cone portion 315 of the extension portion 31 and the proximal end region 3115 of the cylindrical portion 311 are covered with an insulating coating.

The electrode portions of each of the strip electrodes 51 to 54 formed on the outer surface of the proximal neck portion 35, the proximal cone portion 315 of the extension portion 31, and the proximal region 3115 of the cylindrical portion 311 are covered with insulation. As an embodiment, a resin layer 67 is formed on the outer surface of the proximal neck portion 35, the proximal cone portion 315, and the outer surface of the proximal region 3115 of the cylindrical portion 311 so as to cover these electrode portions. can be mentioned.

As the resin forming the resin layer 67, the same resin as the resin forming the resin layer 65 can be used. As a method of forming the resin layer 67, the same method of forming the resin layer 65 can be used.

The length of the base end region 3115 of the cylindrical portion 311 forming the resin layer 67 is usually 1 to 3 mm, preferably 2 mm.
By setting the length of the base end region 3115 to 1 mm or longer (each electrode portion of the strip electrodes 51 to 54 formed in the base end region 3115 is covered with an insulating resin layer 67), the strip electrodes 51 to 54 Even if a high-frequency current is applied to each of , it is possible to prevent the proximal end cone portion 315 from becoming hot due to heat conduction.
In addition, by setting the length of the base end region 3115 to 3 mm or less, the base end region 3115 can be displaced by heat conduction from the region of the cylindrical portion 311 other than the base end region 3115 (region where the electrode portion is not covered with insulation). The temperature is raised to a temperature at which cauterization is possible, and cauterization treatment can be performed using the entire cylindrical portion 311 including the proximal end region 3115 .

According to the balloon-type electrode catheter 300 of this embodiment, the cylindrical portion 311 of the expanded portion 31 of the balloon 30 can perform cauterization treatment on the vessel or lesion tissue therearound.
In addition, since the electrode portions of each of the strip electrodes 51 to 54 formed on the outer surface of the proximal neck portion 35 and the proximal cone portion 315 of the extension portion 31 are insulated and coated with the resin layer 67, cautery During treatment, the vicinity of these electrode portions does not become hot.
Furthermore, since the electrode portions of the strip electrodes 51 to 54 formed on the outer surface of the proximal end region 3115 of the cylindrical portion 311 are covered with an insulating coating, heat conduction from the proximal end region 3115 causes the proximal cone portion 315 to temperature rise can be prevented.
As a result, it is possible to prevent cauterization of the vascular site in contact with the proximal-side neck portion 35 and the proximal-side cone portion 315 of the expansion section 31 and the tissue therearound. (Re)stenosis can be prevented.

<Fourth Embodiment>
A balloon-type electrode catheter 400 of this embodiment having a distal end portion shown in FIG. , each electrode portion of the strip-shaped electrodes 51 to 54 formed on the outer surface of the proximal neck portion 35, the strip-shaped electrode formed on the outer surface of the proximal cone portion 315 of the extension portion 31 Each of the electrodes 51 to 54 and each of the strip electrodes 51 to 54 formed on the outer surface of the base end region 3115 of the cylindrical portion 311 are insulated and covered with a resin layer 67 . In FIG. 27, the strip electrodes 54 arranged to face the strip electrodes 52 are not shown.

The balloon electrode catheter 400 of the present embodiment is characterized in that the electrode portions of the strip electrodes 51 to 54 formed on the outer surface of the distal end region 3113 of the cylindrical portion 311 are coated with the resin layer 68 for insulation. , is different from the electrode catheter 300 of the third embodiment.

As a mode for insulating and covering the electrode portions of each of the strip electrodes 51 to 54 formed on the outer surface of the tip region 3113 of the cylindrical portion 311, the tip region of the cylindrical portion 311 is covered so as to cover these electrode portions. A mode in which the resin layer 68 is formed on the outer surface of the 3113 can be mentioned.

As the resin forming the resin layer 68, the same resin as the resin forming the resin layer 65 can be used. As a method of forming the resin layer 68, the same method of forming the resin layer 65 can be used.

The length of the tip region 3113 of the cylindrical portion 311 forming the resin layer 68 is usually 1 to 3 mm, and a preferred example is 2 mm.
By setting the length of the tip region 3113 to 1 mm or longer (the electrode portion of each of the strip electrodes 51 to 54 formed in the tip region 3113 is covered with an insulating resin layer 68), each of the strip electrodes 51 to 54 Even if a high-frequency current is applied to the tip end cone portion 313 due to heat conduction, it is possible to prevent the tip end cone portion 313 from becoming hot.
In addition, by setting the length of the tip region 3113 to 3 mm or less, the tip region 3113 can be cauterized by heat conduction from the region of the cylindrical portion 311 other than the tip region 3113 (the region where the electrode portion is not covered with insulation). The entire cylindrical portion 311 , including the tip region 3113 , can be heated to a temperature and ablation treatment can be performed.

According to the balloon-type electrode catheter 400 of this embodiment, the same effects as those of the balloon-type electrode catheter 300 of the third embodiment can be obtained.
Further, since the electrode portions of the strip electrodes 51 to 54 formed on the outer surface of the distal end region 3113 of the cylindrical portion 311 of the extension portion 31 are insulated and coated with the resin layer 68, the distal end region can be Heat conduction from 3113 can prevent distal cone portion 313 from heating up, thereby preventing cauterization of the vascular site and surrounding tissue in contact with distal cone portion 313 . can be prevented.
Further, by appropriately adjusting the length of the distal end region 3113, the temperature of the distal end region 3113 is increased by heat conduction from the region of the cylindrical portion 311 other than the distal end region 3113, and the vascular site in contact with the distal end region 3113 is treated. Alternatively, the surrounding tissue can be cauterized (the entire cylindrical portion 311 can be treated as the cauterization region).

100 balloon type electrode catheter 10 outer tube 10L central lumen 101L to 105L sub-lumen (sub-lumen for fluid supply)
107L~109L, 111L sub-lumen (sub-lumen for fluid discharge)
106L, 110L, 112L Sub-lumen 11 Circular tubular portion 12 Distal end surface of circular tubular portion 13 Semi-circular tubular portion 14 Distal end surface of semi-circular tubular portion 20 Y connector 21 Electrical connector 22 Fluid supply connector 23 Fluid discharge connector 24 Guide wire Connector 26 Conductive wire protection tube 27 Fluid supply tube 28 Fluid discharge tube 30 Balloon 31 Expanded portion 311 Cylindrical portion 3113 Distal region of cylindrical portion 3115 Proximal region of cylindrical portion 313 Distal cone portion 315 Proximal cone portion 33 distal side neck portion 35 proximal side neck portion 41 inner tube 46 distal tip 51-54 strip electrodes (surface electrodes)
60 metal ring 65 resin layer 70 conducting wire 80 temperature sensor (thermocouple)
81 temperature measuring part of temperature sensor 90 sealing material 95 adhesive 200 balloon type electrode catheter 66 resin layer 300 balloon type electrode catheter 67 resin layer 400 balloon type electrode catheter 68 resin layer

Claims

A balloon-type electrode catheter for intravascularly introduced ablation treatment of a vessel or surrounding tissue, comprising:
an outer tube having a central lumen and a plurality of sub-lumens arranged therearound;
a current-carrying connector arranged on the base end side of the outer tube;
It has an expanded portion composed of a distal cone portion, a cylindrical portion, and a proximal cone portion, and a neck portion continuous to both ends of the expanded portion, and the neck portion on the proximal side is the distal end portion of the outer tube. a balloon connected to the distal end side of the outer tube by being fixed to the
an inner tube that has a lumen through which a guide wire can be passed, is inserted through the central lumen of the outer tube, extends from the opening of the central lumen into the balloon, and extends inside the balloon;
A distal tip that has a lumen that communicates with the lumen of the inner tube, is connected to the distal end of the inner tube inside the balloon, is fixed to the neck portion on the distal side, and extends to the outside of the balloon. When,
a metal ring attached to the distal or proximal neck;
From the metal thin film formed on the outer surface of the neck portion electrically connected to the metal ring and to which the metal ring is attached, the cone portion of the extension portion continuous with the neck portion, and the cylindrical portion a surface electrode that is
The tip is fixed to the inner peripheral surface of the metal ring, extends to the sub-lumen of either the inside of the balloon or the outer tube, and the base end is fixed to the current-carrying connector, a conductor for electrically connecting the surface electrode and the conducting connector;
A balloon-type electrode catheter, wherein an electrode portion formed on the outer surface of the cone portion continuous with the neck portion to which the metal ring is attached is coated with an insulating material.
The metal ring is attached to the neck portion on the tip side,
the surface electrode is formed on the outer surface of the neck portion on the distal side, the distal cone portion of the extension portion, and the cylindrical portion;
2. The balloon electrode catheter according to claim 1, wherein the electrode portion formed on the outer surface of said distal cone portion is coated with an insulating material.
3. The electrode portion formed on the outer surface of the neck portion on the distal end side, the distal cone portion of the extension portion, and the distal end region of the cylindrical portion is covered with an insulating coating according to claim 2. balloon electrode catheter.
The balloon electrode catheter according to claim 3, wherein the tip region of the cylindrical portion has a length of 1 to 3 mm.
The balloon-type electrode catheter according to claim 3 or 4, characterized in that the metal ring is covered with an insulating coating.
The surface electrode is formed up to a base end position of the cylindrical portion,
The balloon type electrode catheter according to any one of claims 3 to 5, wherein the electrode portion formed on the outer surface of the proximal end region of the cylindrical portion is coated with an insulating material.
The balloon electrode catheter according to claim 6, wherein the proximal region of the cylindrical portion has a length of 1 to 3 mm.
The surface electrodes are formed so as to extend along the axial direction of the balloon, and are composed of a plurality of strip-shaped electrodes arranged at equal angular intervals along the circumferential direction of the balloon. is fixed to the outer peripheral surface of the metal ring, thereby electrically connecting each of the strip-shaped electrodes to the metal ring. type electrode catheter.
The metal ring is attached to the proximal neck portion,
the surface electrode is formed on the outer surface of the proximal neck portion, the proximal cone portion of the extension portion, and the cylindrical portion;
2. The balloon electrode catheter according to claim 1, wherein the electrode portion formed on the outer surface of said proximal end cone portion is coated with an insulating material.
3. An electrode portion formed on the outer surface of the proximal neck portion, the proximal cone portion of the extension portion, and the proximal region of the cylindrical portion is coated with an insulating coating. 9. The balloon-type electrode catheter according to 9.
The balloon electrode catheter according to claim 10, wherein the proximal region of the cylindrical portion has a length of 1 to 3 mm.
The balloon-type electrode catheter according to claim 10 or 11, wherein the metal ring is covered with an insulating coating.
The surface electrode is formed up to a tip position of the cylindrical portion,
13. The balloon electrode catheter according to any one of claims 10 to 12, wherein the electrode portion formed on the outer surface of the distal end region of said cylindrical portion is coated with an insulating material.
The balloon electrode catheter according to claim 13, wherein the tip region of the cylindrical portion has a length of 1 to 3 mm.
The surface electrodes are formed so as to extend along the axial direction of the balloon, and are composed of a plurality of strip-shaped electrodes arranged at equal angular intervals along the circumferential direction of the balloon. 15. The method according to any one of claims 9 to 14, wherein each of the strip-shaped electrodes and the metal ring are electrically connected by fixing a portion to the outer peripheral surface of the metal ring. Balloon electrode catheter.