JP5561784B2 - Electrode catheter - Google Patents

Description

  The present invention relates to an electrode catheter such as an ablation catheter.

  For example, in the case of an electrode catheter inserted into the heart through arterial blood vessels, the orientation of the distal end (tip) of the catheter inserted into the heart is set to the proximal end (rear end or proximal side) of the catheter placed outside the body. ) Needs to be manipulated to change (deflection).

  As a mechanism for operating and deflecting the distal end of the catheter on the proximal side as described above, conventionally, for example, a support plate (plate spring) having a spring force and a flexible spring inside the distal end portion of the catheter, Those equipped with a tension wire or the like are known. In that mechanism, it is possible to bend the leaf spring by manipulating the pull wire on the proximal side, so that the distal end of the catheter can be turned in a predetermined direction.

  FIG. 5 is a longitudinal sectional view at the distal end portion of such an electrode catheter, and FIG. 6 is a sectional view taken along the line VI-VI in FIG.

  This electrode catheter includes a single lumen type catheter tube 16 having a flexible portion at the tip, a deflection mechanism (a tension wire 50 and a leaf spring 55) for bending the flexible portion of the catheter tube 16, The tip electrode 31 fixed to the tip, the lead wire 41 connected to the tip electrode 31, the ring electrode 37 bonded and fixed to the flexible portion of the catheter tube 16, and the ring electrode 37 were connected to each other. Lead wire 42.

The leaf spring 55 constituting the deflection mechanism extends along the central axis (O) of the catheter tube 16 to the lumen of the flexible portion of the catheter tube 16, and the tip of the leaf spring 55 is solder 60 filled inside. Is fixed to the tip electrode 31.
The pulling wire 50 constituting the deflection mechanism is eccentric from the central axis (O) of the catheter tube 16 and extends to the lumen of the catheter tube 16. The tip of the tension wire 50 is also fixed to the tip electrode 31 by the solder 60 filled therein, and the rear end of the tension wire 50 can be pulled. By pulling the rear end of the pulling wire 50, the flexible portion of the catheter tube 16 can be bent in the eccentric direction of the pulling wire 50 (the direction indicated by the arrow A in FIGS. 5 and 6).

  In the tube wall of the flexible portion of the catheter tube 16, side holes 18 extending from the outer peripheral surface of the catheter tube 16 to the lumen are arranged in correspondence with the fixing position of the ring electrode 37. Each of the lead wires 42 is connected to the ring-shaped electrode 37 by being welded to the inner peripheral surface of the ring-shaped electrode 37 at the tip portion thereof, and enters the lumen of the catheter tube 16 from each of the side holes 18. Extends into the lumen of the catheter tube 16.

  The opening of the side hole 18 (opening on the outer peripheral surface) is liquid-tightly closed by the ring-shaped electrode 37 that is adhesively fixed to the outer peripheral surface of the catheter tube 16 so as to cover the side hole 18. Prevents blood from entering.

  As shown in FIGS. 5 and 6, in the lumen of the catheter tube 16, the tension wire 50 and each of the lead wires 42 connected to the ring electrode 37 extend to positions facing each other with the leaf spring 55 interposed therebetween. doing. Thereby, it is possible to avoid interference (sliding) between the pulling wire 50 moving in the axial direction and the lead wire 42 during the pulling operation (tip deflection operation). Here, in order to arrange the lead wire 42 in this way, the side hole 18 for allowing the lead wire 42 to enter the lumen may be formed in the tube wall opposite to the eccentric direction of the pulling wire 50.

  In addition to the above, in a conventionally known electrode catheter capable of tip deflection operation, the side hole for allowing the lead wire of the ring electrode to enter the lumen of the catheter tube has an eccentric direction of the pulling wire (the deflection direction of the electrode catheter) ), And the tension wire and the lead wire of the ring-like electrode extend in a state of being separated from or separated from each other in the lumen of the catheter tube (for example, Patent Documents) 1-3).

JP 2010-284537 (FIGS. 1 and 2) JP2007-181690 (FIG. 4b) JP 2006-192293 (FIGS. 1 and 2)

In the conventionally known electrode catheter as shown in FIGS. 5 and 6, when the rear end of the pulling wire 50 is pulled and the flexible portion at the tip is bent in the bending direction indicated by the arrow A, the pulling is performed. Each of the side holes 18 arranged on the tube wall opposite to the eccentric direction of the wire 50 is positioned outside the curved curve.
Here, since a relatively large tensile force in the tube axis direction acts on the side hole 18 (the tube wall region around the side hole 18) located outside the curve, each of the side holes 18 is affected by this tensile force. Tries to spread in the tube axis direction.

At this time, there is no problem when the electrode width of the ring-shaped electrode 37 is sufficiently large with respect to the diameter of the side hole 18 (the ring-shaped electrode 37 covers the opening of the side hole 18 with a sufficient margin). Otherwise, a part of the opening of the side hole extending in the tube axis direction protrudes from the ring-shaped electrode covering the opening and is exposed to the outer peripheral surface. As a result, a part of the exposed opening May cause blood to enter the lumen of the catheter tube.
Further, the adhesive (the adhesive layer formed around the opening) that has fixed the ring-shaped electrode 37 is peeled off by the tensile force acting on the tube wall region around the side hole 18, and the opening of the side hole 18 is removed. As a result, blood may enter the lumen of the catheter tube 10.
When blood enters the lumen of the catheter tube 10, for example, a phenomenon (drift phenomenon) in which the baseline of the electrocardiogram becomes unstable occurs.

Each of the lead wires 42 that have entered the lumen (single lumen) from the side holes 18 arranged in the catheter tube 10 has a tube wall on the side where the side holes 18 are arranged (opposite to the eccentric direction of the tension wire). It extends to the lumen along the inner circumference.
For this reason, when the rear end of the pulling wire 50 is pulled and the flexible portion at the tip is bent in the direction indicated by the arrow A (the eccentric direction of the pulling wire), each of the lead wires 42 has a bent shape. Since it extends to the lumen along the inner peripheral surface of the tube shaft portion outside a certain curve, a relatively large tensile force acts on each of the lead wires 42, and this lead wire 42 causes a ring-shaped electrode. Each of 37 is pulled to the rear end side. As a result, the opening of the side hole 18 (protruding from the ring-shaped electrode 37), the shearing of the adhesive around the opening, and the penetration of blood into the lumen of the catheter tube 10 are promoted. .
Furthermore, it is conceivable that the lead wire 42 is disconnected due to the tensile force acting on each of the lead wires 42.

  The present invention has been made based on the above circumstances, and an object of the present invention is to reliably prevent blood from entering the lumen of the catheter tube in accordance with the tip deflection operation. An object of the present invention is to provide an electrode catheter in which there is no fear of disconnection of a wire or the like.

(1) The electrode catheter of the present invention includes a tube member having a flexible portion (hereinafter referred to as “tip flexible portion”) at the tip,
A control handle connected to the proximal side of the tube member;
A single puller wire that is eccentric from the central axis of the tube member and extends to the lumen of the tube member, the rear end of which can be pulled in order to bend the distal flexible portion of the tube member in one direction ;
A plurality of ring-shaped electrodes, each of which is spaced apart and fixed to the outer peripheral surface of the distal end flexible portion of the tube member;
A plurality of lead wires connected to each of the plurality of ring-shaped electrodes;
A plurality of side holes extending from the outer peripheral surface of the tube member to the lumen are formed on the tube wall of the distal end flexible portion of the tube member corresponding to the fixing position of the ring-shaped electrode,
Each of the plurality of lead wires is connected to the ring-shaped electrode by being joined to an inner peripheral surface of the ring-shaped electrode at a tip portion thereof, and the tube member is connected to each of the plurality of side holes. An electrode catheter that enters the lumen and extends into the lumen of the tube member and the bore of the control handle;
The ring-shaped electrode has an electrode width (w) of 0.3 to 4.0 mm, a side hole diameter (d) of 0.2 to 3.0 mm, and a ratio (d / w) of 0.3 to 1 of both. .0,
In a cross-sectional view when the distal flexible portion of the tube member in which each of the plurality of side holes is formed is cut along a plane perpendicular to the central axis of the tube member,
A straight line connecting the central axis of the tube member and the central axis of the tension wire (the eccentric direction of the tension wire);
An angle (α) formed between a central axis of the tube member and a straight line connecting the centers of the side holes is 20 ° or less .
(2) Further , it is particularly preferable that the angle (α) is substantially 0 °.

In the electrode catheter having such a configuration, when the rear end of the pulling wire is pulled to deflect the distal flexible portion in the eccentric direction of the pulling wire, the angle (α) is at a position where it is 100 ° or less. A tensile force that expands the side hole in the tube axis direction does not act on the formed side hole. Therefore, even when the opening of the side hole is not covered with sufficient margin by the ring-shaped electrode [the ratio (d / w) is 0.3 or more], a part of the opening of the side hole is the ring-shaped electrode. It does not protrude from the outer peripheral surface.
Also, when the rear end of the tension wire is pulled to deflect the tip flexible portion in the eccentric direction of the tension wire, the periphery of the side hole formed at a position where the angle (α) is 100 ° or less In the tube wall region, the tensile force that peels off the adhesive (adhesive layer formed around the opening) that fixes the ring electrode does not act.
As a result, blood does not enter the lumen of the catheter tube from the side hole formed at a position where the angle (α) is 100 ° or less, and the occurrence of the drift phenomenon associated therewith is surely prevented. be able to.

  Further, even if the rear end of the pulling wire is pulled and the tip flexible portion is bent in the eccentric direction of the pulling wire, the lumen from the side hole formed at the position where the angle (α) is 100 ° or less. A large tensile force that breaks the lead wire that has entered the wire does not act.

Further , according to the electrode catheter in which the angle (α) is 20 ° or less, particularly substantially 0 °, the extension of the lead wire can be achieved even in a mode in which a leaf spring is used as a deflection mechanism for deflecting the tip flexible portion. Sufficient space can be secured.

(3) Moreover, it is preferable that the said ratio (d / w) is 0.6-0.9.

(4) Moreover, the electrode catheter of the present invention includes a tube member having a single lumen structure having a tip flexible portion,
A control handle connected to the proximal side of the tube member;
In order to bend the distal flexible portion of the tube member in both directions, two tension wires that are eccentric from the central axis of the tube member and extend to the lumen of the tube member, the rear end of which can be pulled;
A plurality of ring-shaped electrodes each fixed to the outer peripheral surface of the distal end flexible portion of the tube member,
A plurality of lead wires connected to each of the plurality of ring-shaped electrodes;
A plurality of side holes extending from the outer peripheral surface of the tube member to the lumen are formed on the tube wall of the distal end flexible portion of the tube member corresponding to the fixing position of the ring-shaped electrode,
Each of the plurality of lead wires is connected to the ring-shaped electrode by being joined to an inner peripheral surface of the ring-shaped electrode at a tip portion thereof, and the tube member is connected to each of the plurality of side holes. An electrode catheter that enters the lumen and extends into the lumen of the tube member and the bore of the control handle;
The ring-shaped electrode has an electrode width (w) of 0.3 to 4.0 mm, a side hole diameter (d) of 0.2 to 3.0 mm, and a ratio (d / w) of 0.3 to 1 of both. .0,
In a cross-sectional view when the distal flexible portion of the tube member in which each of the plurality of side holes is formed is cut along a plane perpendicular to the central axis of the tube member,
A straight line connecting the central axis of the tube member and the central axis of the tension wire;
An angle (α) formed by a central axis of the tube member and a straight line connecting the centers of the side holes is substantially 90 °.

As described above, even if the distal end flexible portion is an electrode catheter that can be bent in two directions, it is possible to reliably prevent blood from entering the lumen of the catheter tube and disconnection of the lead wire due to the distal end deflection operation. it can.
In addition, even when the rear end of any of the pulling wires is pulled, the amount of expansion / contraction deformation of the side hole and the surrounding tube wall region is theoretically zero, so an adhesive (adhesive layer formed around the opening) Can be reliably prevented.

  According to the electrode catheter of the present invention, blood can be prevented from entering the lumen of the catheter tube due to the tip deflection operation, and the lead wire is disconnected without causing a drift phenomenon due to blood intrusion. There is no fear.

It is a perspective view which shows the electrode catheter which concerns on one Embodiment of this invention. It is a longitudinal cross-sectional view in the front-end | tip part of the electrode catheter shown in FIG. FIG. 3 is a sectional view taken along line IIIA-IIIA in FIG. 2. FIG. 3 is a sectional view taken along the line IIIB-IIIB in FIG. 2. It is IIIC-IIIC sectional drawing of FIG. It is a cross-sectional view in the front-end | tip part of the electrode catheter which concerns on other embodiment of this invention. It is a cross-sectional view in the front-end | tip part of the electrode catheter which concerns on other embodiment of this invention. It is a cross-sectional view in the front-end | tip part of the electrode catheter which concerns on other embodiment of this invention. It is a longitudinal cross-sectional view in the front-end | tip part of the conventionally well-known electrode catheter in which a front-end | tip deflection operation is possible. It is VI-VI sectional drawing of FIG.

Hereinafter, the electrode catheter of the present invention will be described with reference to the drawings.
<First Embodiment>
The electrode catheter of this embodiment shown in FIGS. 1, 2, 3A, 3B, and 3C is used, for example, for diagnosis or treatment of arrhythmia in the heart.

  The electrode catheter of this embodiment includes a single lumen structure catheter tube 10 (tube member) having a distal end flexible portion, a control handle 20 connected to the proximal end side of the catheter tube 10, and a proximal end side of the control handle. A connector 70, a tip electrode 31 fixed to the tip of the catheter tube 10, a lead wire 41 connected to the tip electrode 31, and the central axis (O) of the catheter tube 10, the catheter tube The distal end of the catheter tube 10 is eccentric from the central axis (O) of the leaf tube 55 and the central axis (O) of the catheter tube 10. The tip is fixed to the tip electrode 31 by the solder 60 and the rear end is pulled. A tension wire 50 capable of functioning, three ring-shaped electrodes 32 each adhered and fixed to the outer peripheral surface of the distal end flexible portion of the catheter tube 10, and each of the ring-shaped electrodes 32. The side hole 15 extending from the outer peripheral surface of the catheter tube 10 to the lumen corresponds to the fixing position of the ring electrode 32 on the tube wall of the distal end flexible portion of the catheter tube 10. Each of the three lead wires 42 is connected to each of the ring electrodes 32 by being welded to the inner peripheral surface of the ring electrode 32 at the tip thereof, An electrode catheter that enters the lumen of the catheter tube 10 from each of the holes 15 and extends into the lumen of the catheter tube 10 and the inner bore of the control handle 20; The electrode width (w) of the electrode 32 is 0.3 to 4.0 mm, the diameter (d) of the side hole 15 is 0.2 to 3.0 mm, and the ratio (d / w) of both is 0.3 to 1 mm. 0, and the distal flexible portion of the catheter tube 10 in which each of the side holes 15 is formed was cut by a plane perpendicular to the central axis of the catheter tube 10 and including the center (axis) of the side hole 15 3A, FIG. 3B, and FIG. 3C, the straight line connecting the central axis (O) of the catheter tube 10 and the central axis of the tension wire 50 (the eccentric direction of the tension wire 50) and the center of the catheter tube 10 In this electrode catheter, the straight line connecting the axis (O) and the center of the side hole 15 coincides (the angle (α) formed by both straight lines is 0 °).

The catheter tube 10 is a single lumen structure tube formed of a hollow tube member.
The catheter tube 10 may be composed of a tube having the same characteristics along the axial direction, but is formed integrally with the distal end portion having relatively high flexibility and the distal end portion in the axial direction. And a proximal end portion that is relatively more rigid than the distal end portion. Examples of the constituent material of the catheter tube 10 include synthetic resins such as polyolefin, polyamide, polyether polyamide, and polyurethane.

The distal end region of the catheter tube 10 is a distal flexible portion.
Here, the “tip flexible portion” refers to a tip portion of the catheter tube 10 that can be bent (bent) by pulling the pulling wire 50.

The outer diameter of the catheter tube 10 is usually 0.6 to 3.0 mm, preferably 1.3 to 3.0 mm.
The inner diameter of the catheter tube 10 is usually 0.5 to 2.5 mm, preferably 1.0 to 1.5 mm.
The length of the catheter tube 10 is usually 400 to 1500 mm, and preferably 700 to 1200 mm.
The length of the tip flexible portion is, for example, 30 to 200 mm.

A control handle 20 is connected to the proximal end side of the catheter tube 10.
In FIG. 1, 21 is a grip and 22 is a knob.
By sliding the knob 22 of the control handle 20 in the X direction (front end side or rear end side) shown in FIG. 1, the rear end of the pulling wire 50 is pulled, and the distal end flexible portion of the catheter tube 10 is shown in FIG. It can be bent in the A direction shown. Further, by rotating the control handle 20, the rotational torque can be transmitted to the catheter tube 10.
Therefore, by operating the control handle 20, the tip portion (tip flexible portion) of the catheter tube 10 can be guided to the target site.

A distal electrode 31 is fixed to the distal end of the catheter tube 10.
The tip electrode 31 is made of a metal having good thermal conductivity, such as aluminum, copper, stainless steel, gold, or platinum. In addition, in order to give the contrast property with respect to a X-ray favorable, it is preferable to comprise with platinum etc. The outer diameter of the tip electrode 31 is not particularly limited, but is preferably approximately the same as the outer diameter of the catheter tube 10.
The outer diameter of the tip electrode 31 is not particularly limited, but is preferably about the same as the outer diameter of the catheter tube 10 and is usually about 0.6 to 3 mm.
A lead wire 41 is connected to the tip electrode 31. The lead wire 41 connected to the distal electrode 31 extends to the lumen of the catheter tube 10 and the inner hole of the control handle 20 and is pulled out from the connector 70.

The inner concave portion of the tip electrode 31 is filled with solder 60 for connecting and fixing the lead wire 41, the leaf spring 55, and the tension wire 50 to the tip electrode 31.
The material of the solder 60 is not particularly limited. For example, Sn—Pb is generally used. However, Sn—Pb—Ag or Sn—Pb—Cu may be used, and Pb-free Sn—Ag— Cu, Sn—Cu, Sn—Ag, Sn—Ag—Cu—Bi, or the like can be used.

The electrode catheter of this embodiment includes a leaf spring 55 and a tension wire 50 as a deflection mechanism for deflecting the flexible portion of the catheter tube 10.
The leaf spring 55 constituting the deflection mechanism is a swinging member that can be deformed in the bending direction.
The leaf spring 55 extends along the central axis (O) of the catheter tube 10 to the lumen of the flexible portion of the catheter tube 10, and the tip thereof is fixed to the tip electrode 31 by the solder 60 filled in the inner recess. ing.
The axial length of the leaf spring 55 is not particularly limited, and is 40 to 300 mm, for example. The width of the leaf spring 55 is not particularly limited as long as it fits within the catheter tube 10.
The material of the leaf spring 55 is not particularly limited, and examples thereof include metal materials such as stainless steel, Ni—Ti alloy, and Co—Ni alloy, and polymer materials such as fluorine resin and polyamide resin.

The tension wire 50 constituting the deflection mechanism is eccentric from the central axis (O) of the catheter tube 10 and extends to the lumen of the catheter tube 10 so as to be movable in the axial direction. The tip of the tension wire 50 is fixed to the tip electrode 31 by a solder 60 filled in the inner recess. The tip of the tension wire 50 may be fixed to the tip of the leaf spring 55.
The rear end of the pull wire 50 is fixed inside the control handle 20 and can be pulled.
The tension wire 50 can be made of, for example, a metal such as stainless steel or a Ni—Ti superelastic alloy, but is not necessarily made of a metal, for example, a high-strength non-conductive wire. Also good. By configuring the pull wire with a non-conductive wire, the cause of high frequency noise can be reduced.

When the operator slides the knob 22 of the control handle 20 in the X direction (front end side or rear end side), the rear end of the pull wire 50 is pulled with respect to the catheter tube 10 by a piston mechanism (not shown) in the control handle 20. . Thereby, the distal end flexible portion of the catheter tube 10 can be bent in the direction indicated by the arrow A in FIGS. 2 and 3A to 3C (the eccentric direction of the pulling wire 50).
Of course, the deflection mechanism is not limited to this.

Three ring electrodes 32 are bonded and fixed to the outer peripheral surface of the distal flexible portion of the catheter tube 10.
Examples of the constituent material of the ring electrode 32 include the same metals as those exemplified as the constituent material of the tip electrode 31.
The outer diameter of the ring-shaped electrode 32 is not particularly limited, but is preferably about the same as the outer diameter of the catheter tube 10 and is usually about 0.6 to 3 mm.
Of course, the number of ring-shaped electrodes attached to the distal flexible portion of the catheter tube 10 is not limited to three.

A lead wire 42 is connected to each of the ring electrodes 32. The lead wire 42 is formed by coating a metal core wire with a resin.
A side hole 15 extending from the outer peripheral surface of the catheter tube 10 to the lumen is formed in the tube wall of the distal flexible portion of the catheter tube 10 corresponding to the fixing position of the ring-shaped electrode 32. Each of the lead wires 42 is connected to each of the ring-shaped electrodes 32 by peeling the coating resin at the tip thereof to expose the metal core wire and then spot-welding the inner peripheral surface of the ring-shaped electrode 32. And enters the lumen of the catheter tube 10 from each of the side holes 15, extends into the lumen of the catheter tube 10 and the inner hole of the control handle 20, and is pulled out from the connector 70.

In the electrode catheter of the present embodiment, the electrode width (w) of the ring-shaped electrode 32 (length in the axial direction of the catheter tube 10) varies depending on the purpose of the electrode, but is 0.3 to 4.0 mm, A suitable example is 1.0 mm.
Moreover, the diameter (d) of the side hole 15 formed in the tube wall of the distal end flexible portion of the catheter tube 10 is 0.2 to 3.0 mm, and 0.8 mm if a suitable example is shown.
And the ratio (d / w) of both is 0.3-1.0, Preferably it is 0.6-0.9, 0.8 (0.8mm / 1.0mm) is shown if a suitable example is shown. is there. In this case, the distance from the end of the ring electrode 32 to the opening edge of the side hole 15 is only 0.1 mm. Thus, when the ring-shaped electrode cannot close the opening of the side hole with a sufficient margin, it is meaningful to employ the present invention.

When the ratio (d / w) is less than 0.3, that is, when the electrode width is sufficiently large with respect to the side holes, it is out of the range of the present invention. On the other hand, when the ratio (d / w) exceeds 1.0, the opening of the side hole cannot be blocked by the ring electrode.
Note that if the diameter (d) of the side hole is too small, the lead wire insertion operation becomes difficult. On the other hand, if the diameter (d) of the side hole is excessive, it may be difficult to reliably close the opening of the side hole by the ring electrode.

  3A to 3C are cross-sectional views (cross-sectional views) of the distal flexible portion of the catheter tube 10 cut along a plane perpendicular to the central axis of the catheter tube 10 and including the center (axis) of the side hole 15. Figure).

3A to 3C, a straight line connecting the central axis (O) of the catheter tube 10 and the central axis of the tension wire 50 (the eccentric direction of the tension wire 50), the central axis (O) of the catheter tube 10, and the side holes 15. The straight line connecting the centers coincides (the angle (α) formed by both straight lines is 0 °).
That is, in the electrode catheter of this embodiment, all of the three side holes 15 arranged in the distal flexible portion of the catheter tube 10 are formed on the tube wall on the same side as the eccentric direction of the tension wire 50.

In the electrode catheter of the present embodiment having such a configuration, when the rear end of the tension wire 50 is pulled, the tip flexible portion is bent in the direction indicated by the arrow A (the eccentric direction of the tension wire 50). Each of the side holes 15 arranged in the tube wall on the same side as the eccentric direction of the pulling wire 50 is positioned inside the curve having a bent shape.
Here, the compressive force in the tube axis direction acts on the side hole 15 (the tube wall region around the side hole 15) located inside the curve, and the tensile force does not act.
Therefore, even when the opening of the side hole 15 is not covered with a sufficient margin by the ring-shaped electrode 32 (the ratio (d / w) is 0.3 or more), the side hole 15 can be used during the tip deflection operation. Therefore, a part of the opening of the side hole 15 does not protrude from the ring-shaped electrode 32 and is not exposed to the outer peripheral surface.
Further, the adhesive (an adhesive layer formed around the opening) that fixes the ring-shaped electrode 32 to the outer peripheral surface of the catheter tube 10 does not peel off.
In this way, blood can enter the lumen of the catheter tube 10 from the side hole 15 arranged on the tube wall on the same side as the eccentric direction of the pulling wire 50 so as to be located inside the curved curve. Therefore, it is possible to reliably prevent the occurrence of the drift phenomenon associated therewith.

  When the tip flexible portion is bent in the bending direction indicated by arrow A, each of the lead wires 42 extends to the lumen along the inner peripheral surface of the tube shaft portion inside the curved curve. Therefore, the tensile force does not act on each of the lead wires 42, and therefore there is no possibility that the lead wires 42 are disconnected.

  Further, according to the electrode catheter of the present embodiment, it is not necessary to perform the exact alignment of the ring-shaped electrode 32 in consideration of the expansion of the side hole 15 at the time of tip deflection operation, unlike the conventional electrode catheter. The production efficiency can be greatly improved.

Second Embodiment
The electrode catheter of this embodiment has the same appearance as that shown in FIG.
4A is a cross-sectional view (a cross-sectional view corresponding to FIG. 3A in the first embodiment) of the distal end portion of the electrode catheter according to the present embodiment, and shows the catheter tube 10a in which each of the side holes 15a is formed. The cross section when the distal end flexible portion is cut by a plane perpendicular to the central axis of the catheter tube 10a and including the center (axis) of the side hole 15a is shown.
In addition, the same code | symbol is attached | subjected to the component which is the same as that of 1st Embodiment, or respond | corresponds.
4A, a straight line connecting the central axis (O) of the catheter tube 10a and the central axis of the pulling wire 50 (the eccentric direction of the pulling wire 50), and the central axis (O) of the catheter tube 10a and the center of the side hole 15a are connected. The angle (α) made with the straight line is 45 °.

In the electrode catheter of the present embodiment having such a configuration, when the distal end flexible portion of the catheter tube 10a is bent in the direction indicated by the arrow A (the eccentric direction of the pulling wire 50), it is 45 from the eccentric direction of the pulling wire 50. Each of the side holes 15a arranged in the tube wall with an angular interval of ° is positioned inside the curved curve, and the side wall 15a and the tube wall region around the side hole 15a are arranged in the tube axis direction. The compressive force is applied and the tensile force is not applied.
Therefore, even if the opening of the side hole 15a is not covered with sufficient margin by the ring-shaped electrode 32 (the ratio (d / w) is 0.3 or more), the side hole 15a is not formed during the tip deflection operation. Since it does not expand in the tube axis direction, a part of the opening of the side hole 15a does not protrude from the ring electrode 32 and is not exposed to the outer peripheral surface. Further, the adhesive (an adhesive layer formed around the opening) that fixes the ring-shaped electrode 32 to the outer peripheral surface of the catheter tube 10a does not peel off.
Accordingly, blood does not enter the lumen of the catheter tube 10a from the side holes 15a arranged in the tube wall of the catheter tube 10a, and the occurrence of the drift phenomenon associated therewith can be reliably prevented.

<Third Embodiment>
The electrode catheter of this embodiment has the same appearance as that shown in FIG.
FIG. 4B is a cross-sectional view (a cross-sectional view corresponding to FIG. 3A in the first embodiment) at the distal end portion of the electrode catheter according to the present embodiment, and shows the catheter tube 10b in which each of the side holes 15b is formed. The cross section when the distal end flexible portion is cut by a plane perpendicular to the central axis of the catheter tube 10b and including the center (axis) of the side hole 15b is shown.
In addition, the same code | symbol is attached | subjected to the component which is the same as that of 1st Embodiment, or respond | corresponds.
4B, a straight line connecting the central axis (O) of the catheter tube 10b and the central axis of the pulling wire 50 (the eccentric direction of the pulling wire 50) and the central axis (O) of the catheter tube 10b and the center of the side hole 15b are connected. The angle (α) made with the straight line is 90 °.

In the electrode catheter of this embodiment having such a configuration, when the distal end flexible portion of the catheter tube 10b is bent in the direction indicated by the arrow A (the eccentric direction of the pulling wire 50), it is 90 from the eccentric direction of the pulling wire 50. Each of the side holes 15b arranged on the tube wall with an angular interval of ° is positioned between the inside and the outside of the curved curve, and the side wall 15b and the tube wall region around the side hole 15b include The tensile force in the tube axis direction does not act.
Therefore, even when the opening of the side hole 15b is not sufficiently covered by the ring-shaped electrode 32 (the ratio (d / w) is 0.3 or more), the side hole 15b is not formed during the tip deflection operation. Since it does not expand in the tube axis direction, a part of the opening of the side hole 15b does not protrude from the ring electrode 32 and is not exposed to the outer peripheral surface. In the electrode catheter of the present embodiment, the amount of expansion / contraction deformation of the tube wall region around the side hole 15b during the tip deflection operation is extremely small, so that the adhesive for fixing the ring electrode 32 to the outer peripheral surface of the catheter tube 10b. Peeling of (adhesive layer formed around the opening) can be reliably prevented.

<Fourth embodiment>
The electrode catheter of this embodiment has the same appearance as that shown in FIG.
4C is a cross-sectional view (a cross-sectional view corresponding to FIG. 3A in the first embodiment) at the distal end portion of the electrode catheter according to the present embodiment, and shows the catheter tube 10c in which each of the side holes 15c is formed. The cross section when the distal end flexible portion is cut by a plane perpendicular to the central axis of the catheter tube 10c and including the center (axis) of the side hole 15c is shown.
In addition, the same code | symbol is attached | subjected to the component which is the same as that of 1st Embodiment, or respond | corresponds.

The electrode catheter of this embodiment can bend the tip flexible portion of the catheter tube 10c in both directions indicated by arrows A1 and A2.
Therefore, the electrode catheter of the present embodiment extends to the lumen of the catheter tube 10c so as to face each other across the central axis (O) of the catheter tube 10c, and each of the rear ends can be pulled. And a tension wire 52.

4C, a straight line connecting the central axis (O) of the catheter tube 10c and the central axis of the pulling wire 51 (the eccentric direction of the pulling wire 51), and the central axis (O) of the catheter tube 10c and the center of the side hole 15c are connected. The angle (α ₁ ) made with the straight line is 90 °.
Further, a straight line connecting the central axis (O) of the catheter tube 10c and the central axis of the pulling wire 52 (the eccentric direction of the pulling wire 52), and a straight line connecting the central axis (O) of the catheter tube 10c and the center of the side hole 15c. The angle (α ₂ ) formed by is also 90 °.

In the electrode catheter of the present embodiment having such a configuration, when the distal end flexible portion of the catheter tube 10c is bent in the direction indicated by the arrow A1 (the eccentric direction of the tension wire 51), it is 90 from the eccentric direction of the tension wire 51. Each of the side holes 15c arranged in the tube wall with an angular interval of ° is positioned in the middle between the inside and the outside of the curve that is the bent shape at that time, and the side hole 15c has a shape in the tube axis direction. Tensile force does not work.
Further, when the distal flexible portion of the catheter tube 10c is bent in the direction indicated by the arrow A2 (the eccentric direction of the pulling wire 52), the catheter tube 10c is arranged on the tube wall at an angular interval of 90 ° from the eccentric direction of the pulling wire 52. Each of the side holes 15c is positioned between the inside and the outside of the curve that is the bent shape at that time, and the tensile force in the tube axis direction does not act on the side holes 15c.

  Therefore, even when the opening of the side hole 15c is not covered with sufficient margin by the ring-shaped electrode 32 [the ratio (d / w) is 0.3 or more], the distal flexible portion of the catheter tube 10c is Since the side hole 15c does not expand in the tube axis direction when bent in the direction indicated by the arrow A1 or the arrow A2, a part of the opening of the side hole 15c protrudes from the ring electrode 32 and is exposed to the outer peripheral surface. There is no. In the electrode catheter of the present embodiment, the amount of expansion and contraction of the tube wall region around the side hole 15c at the time of tip deflection operation is extremely small, so that the adhesive that fixes the ring electrode 32 to the outer peripheral surface of the catheter tube 10c. Peeling of (adhesive layer formed around the opening) can be reliably prevented.

DESCRIPTION OF SYMBOLS 10 Catheter tube 10a Catheter tube 10b Catheter tube 10c Catheter tube 15 Side hole 15a Side hole 15b Side hole 15c Side hole 20 Control handle 21 Grip 22 Knob 31 Tip electrode 32 Ring electrode 41 Lead wire 42 Lead wire 50 Tension wire 51 Tension wire 51 52 Tensile wire 55 Leaf spring 60 Solder 70 Connector

Claims (4)

A tube member having a single lumen structure having a flexible portion at the tip;
A control handle connected to the proximal side of the tube member;
A single puller wire that is eccentric from the central axis of the tube member and extends to the lumen of the tube member, the rear end of which can be pulled to deflect the flexible portion of the tube member in one direction ;
A plurality of ring-shaped electrodes, each spaced apart and fixed to the outer peripheral surface of the flexible portion of the tube member;
A plurality of lead wires connected to each of the plurality of ring-shaped electrodes;
In the tube wall of the flexible portion of the tube member, a plurality of side holes extending from the outer peripheral surface of the tube member to the lumen are formed corresponding to the fixing position of the ring-shaped electrode,
Each of the plurality of lead wires is connected to the ring-shaped electrode by being joined to an inner peripheral surface of the ring-shaped electrode at a tip portion thereof, and the tube member is connected to each of the plurality of side holes. An electrode catheter that enters the lumen and extends into the lumen of the tube member and the bore of the control handle;
The ring-shaped electrode has an electrode width (w) of 0.3 to 4.0 mm, a side hole diameter (d) of 0.2 to 3.0 mm, and a ratio (d / w) of 0.3 to 1 of both. .0,
In a cross-sectional view when the flexible portion of the tube member in which each of the plurality of side holes is formed is cut along a plane perpendicular to the central axis of the tube member,
A straight line connecting the central axis of the tube member and the central axis of the tension wire;
An electrode catheter, wherein an angle (α) formed by a central axis of the tube member and a straight line connecting the centers of the side holes is 20 ° or less . The electrode catheter according to claim 1 , wherein the angle (α) is substantially 0 °.   The electrode catheter according to claim 1 or 2, wherein the ratio (d / w) is 0.6 to 0.9. A tube member having a single lumen structure having a flexible portion at the tip;
A control handle connected to the proximal side of the tube member;
In order to bend the flexible part of the tube member in both directions, two tension wires that are eccentric from the central axis of the tube member and extend to the lumen of the tube member, the rear end of which can be pulled;
A plurality of ring-shaped electrodes, each spaced apart and fixed to the outer peripheral surface of the flexible portion of the tube member;
A plurality of lead wires connected to each of the plurality of ring-shaped electrodes;
In the tube wall of the flexible portion of the tube member, a plurality of side holes extending from the outer peripheral surface of the tube member to the lumen are formed corresponding to the fixing position of the ring-shaped electrode,
Each of the plurality of lead wires is connected to the ring-shaped electrode by being joined to an inner peripheral surface of the ring-shaped electrode at a tip portion thereof, and the tube member is connected to each of the plurality of side holes. An electrode catheter that enters the lumen and extends into the lumen of the tube member and the bore of the control handle;
The ring-shaped electrode has an electrode width (w) of 0.3 to 4.0 mm, a side hole diameter (d) of 0.2 to 3.0 mm, and a ratio (d / w) of 0.3 to 1 of both. .0,
In a cross-sectional view when the flexible portion of the tube member in which each of the plurality of side holes is formed is cut along a plane perpendicular to the central axis of the tube member,
A straight line connecting the central axis of the tube member and the central axis of the tension wire;
An electrode catheter characterized in that an angle (α) formed by a central axis of the tube member and a straight line connecting the centers of the side holes is substantially 90 °.

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