JP2010075530A - Catheter allowing distal end deflection - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a catheter allowing distal end deflection, where an operation wire is not detached from the surface of a leaf spring during use by firmly connecting and fixing the operation wire to the leaf spring, regardless of the configuration material of the leaf spring and the configuration material of the operation wire. <P>SOLUTION: The catheter includes: a catheter tube 4; an end chip electrode 10 fixed to the distal end of the catheter tube 4; the leaf spring 20 for swing, which is deformable in a bending direction and arranged in an axial direction in an inner part on the distal end side of the catheter tube 4; the operation wire 30 which is arranged inside the catheter tube 4 and extended in the axial direction, and whose proximal end is operated by pulling; and a ring shape member 40 for caulking and fixing the distal end 303 of the operation wire 30 to one surface 201 and/or the other surface 202 of the distal end 203 in the leaf spring 20. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a tip-deflable catheter, and more specifically, by operating a proximal-side operation unit arranged outside the body, the orientation of the distal end of the catheter inserted into the body cavity can be changed. The present invention relates to a catheter capable of tip deflection operation.

  For example, in the case of an electrode catheter inserted into the heart through an arterial blood vessel, the direction of the distal end of the catheter inserted into the heart (fixed end of the tip electrode) is set to the proximal end of the catheter placed outside the body. There is a need to change (deflect) the operation unit attached to the rear end or the hand side.

Conventionally, a mechanism shown in Patent Document 1 below is known as a mechanism for operating and deflecting the distal end of the catheter on the proximal side.
In the mechanism shown in Patent Document 1, a leaf spring (plate-shaped lead spring) is arranged inside the distal end portion of a flexible catheter, and one surface and / or the other surface of the distal end portion of the leaf spring is arranged. The distal end of the operation wire is fixedly connected to the head. Then, by pulling the proximal end of the operation wire, the leaf spring can be bent and the direction of the distal end of the catheter can be changed.
Here, solder is usually used for connecting and fixing the distal end of the manipulation wire to one side and / or the other side of the leaf spring.

  However, when solder is used for connecting and fixing the operation wire to one surface and / or the other surface of the leaf spring, the component material of the leaf spring (for example, stainless steel, Ni—Ti alloy) and the component material of the manipulation wire (for example, Stainless steel) has poor wettability with solder, so that the operation wire cannot be connected and fixed to one surface and / or the other surface of the leaf spring with sufficient strength. During use of the electrode catheter, the operation wire may be detached from the surface of the leaf spring.

  In addition, in the electrode catheter shown in Patent Document 1, the tip electrode fixed to the distal end of the catheter is connected and fixed (fixed) at two locations, the distal end of the catheter tube and the distal end of the leaf spring. It has only been done.

Here, the connection and fixing of the tip electrode and the distal end of the catheter tube are usually performed by an adhesive, but the adhesive force may be reduced due to deterioration of the adhesive over time.
In addition, solder is usually used for connecting and fixing the tip electrode and the leaf spring, but the constituent material of the leaf spring (stainless steel and Ni—Ti alloy that exhibits good spring properties) It has poor wettability and is difficult to fix with solder.

  For this reason, the tip tip electrode cannot be connected and fixed to the distal end of the catheter with a sufficient fixing force, and the tip tip electrode may drop into the living body during use of the electrode catheter. It is difficult to collect the tip electrode electrode that has fallen into the living body, and it is required that the tip electrode does not fall from the distal end of the catheter tube.

  In response to such a problem, the present applicant connects the distal end of the leaf spring (swing member) to the tip tip electrode, and independently of the connecting portion of the distal end of the leaf spring, the tip tip electrode. Has proposed a catheter capable of tip deflection operation in which the distal end of the operation wire is connected and fixed (see Patent Document 2 below).

FIG. 10 is a cross-sectional view showing the inside of the distal end side of the catheter described in Patent Document 2.
As shown in the figure, a leaf spring 120 as a swinging member is arranged in the vicinity of the distal end of the catheter tube 104, and the distal end of the leaf spring 120 is placed inside the tip electrode 110. It is connected and fixed to the tip electrode 110 by the filled solder 150. A notch is formed at the distal end of the leaf spring 120, and a temperature sensor protective tube 140 is disposed inside the notch. The proximal end of the leaf spring 120 is connected and fixed to the distal end of the coil tube 124 inside the catheter tube 104. In the figure, 112 is a ring-shaped electrode attached to the distal end of the catheter tube 104, and 122 is a reinforcing plate connected to one side of a leaf spring 120.

  Reference numeral 130 denotes a pair of operation wires for bending and deforming the leaf spring 120 in the direction of arrow A or arrow B. At the distal end of the operation wire 130, a large-diameter portion for retaining (removal prevention) is provided. Part) 130a is formed. The distal ends of these operation wires 130 are disposed inside the solder 150 so as to be separated from the leaf springs 120 on both sides of the leaf spring 120, and come out of the solder 150 by the retaining large diameter portion 130a. It has been stopped.

  The proximal end side of the operation wire 130 is inserted into the operation tube 132 so as to be movable in the axial direction. The proximal end of the operation wire 130 is connected to a knob for performing a deflection movement operation (swinging operation) of the distal end portion of the catheter tube 104. By operating the knob, one of the operation wires is operated. By pulling 130, the leaf spring 120 is bent, and the distal end of the catheter can be swung in the direction of arrow A or B.

In the catheter configured as described above, the tip end electrode 110 is not only connected and fixed to the distal end of the catheter tube 104 and the distal end of the leaf spring 120, but separately from the pair of operation wires. Since the distal end of 130 is also connected and fixed, if the distal tip electrode 110 and the distal end of the catheter tube 104 are not fixed, or the distal end of the distal tip electrode 110 and the leaf spring 120 is fixed. Even when the connection with the ends is broken, the tip chip electrode 110 is connected to the distal ends of the pair of operation wires 130, so that the tip chip electrode 110 can be prevented from falling off.
Japanese Patent No. 3232308 JP 2006-61350 A

  However, in the catheter described in Patent Document 2, the distal end of the manipulation wire is attached to the tip tip electrode independently of the connecting portion of the distal end of the leaf spring (away from the distal end of the leaf spring). Because the connection is fixed, when the operation wire is pulled, the distal end of the operation wire comes out of the solder filled in the tip electrode (disconnection from the tip electrode). There is a risk. That is, even if the large-diameter portion for retaining is formed, the contact area with the solder at the distal end of the operation wire is smaller than the contact area at the distal end of the leaf spring. In the case of a material having poor wettability with solder (for example, stainless steel), it is considered that the material will come off with a relatively low tensile force.

The present invention has been made based on the above situation.
The first object of the present invention is to firmly connect and fix the operation wire to the leaf spring regardless of the material of the leaf spring and the material of the operation wire. An object of the present invention is to provide a catheter capable of tip deflection operation that does not cause the operation wire to be detached from the surface.
The second object of the present invention is to prevent the tip of the tip electrode fixed to the distal end of the catheter from falling off, and to fill the inside of the tip of the tip tip electrode when pulling the operation wire. It is an object of the present invention to provide a tip-deflable manipulating catheter capable of preventing the distal end of the manipulating wire from coming off from the solder that is used.
A third object of the present invention is to provide a catheter capable of operating a tip deflection which is superior in manufacturing efficiency as compared with the conventional one.

In order to achieve the above object, the distal deflection operable catheter of the present invention is
A catheter tube;
A tip electrode fixed to the distal end of the catheter tube;
A leaf spring for swinging that is disposed along the axial direction inside the distal end side (near the distal end) of the catheter tube and is deformable in the bending direction;
An operation wire that is arranged so as to extend along the axial direction inside the catheter tube, and whose proximal end is capable of pulling operation;
And a ring-shaped member for caulking and fixing the distal end portion of the operating wire to one surface and / or the other surface of the distal end portion of the leaf spring.

  According to such a configuration, since the distal end portion of the manipulation wire is caulked and fixed to one surface and / or the other surface of the distal end portion of the leaf spring, the constituent material of the leaf spring and the manipulation wire can be reduced. Regardless of the constituent material, the operation wire can be firmly connected and fixed to the leaf spring.

  In the distal deflection operable catheter of the present invention, the distal end of the leaf spring fixed by caulking with the ring-shaped member and the distal end portion of the manipulation wire is filled with solder filled in the distal tip electrode. It is preferably connected and fixed to the chip electrode.

  According to such a configuration, the distal end portion of the leaf spring, the distal end portion of the operation wire, and the ring-shaped member for caulking and fixing them are in contact with the solder filled in the tip chip electrode. Therefore, the tip electrode fixed to the distal end of the catheter tube is added to the distal end of the catheter tube and the distal end of the leaf spring by a ring-shaped member. It is also connected and fixed (fixed) to the distal end portion of the operation wire that is caulked and fixed to the distal end portion of the spring, and the contact area with the solder increases due to the ring-shaped member being embedded. Further, the pulling resistance force (fixing force of the tip electrode) of the leaf spring and the operation wire from the solder increases. Therefore, it is possible to reliably prevent the distal tip electrode from dropping from the catheter tube.

  Further, the distal end portion of the manipulation wire is caulked and fixed to one surface and / or the other surface of the distal end portion of the leaf spring by the ring-shaped member (the distal end portion of the leaf spring and the manipulation wire Since the distal end and the ring-shaped member are in contact with the solder), the distal end of the leaf spring and the ring-shaped member are pulled out against the force to pull out the operation wire. Acts as a stop (pull-out resistance). Thereby, when the operation wire is pulled, it is possible to reliably prevent the distal end of the operation wire from coming out of the solder filled in the tip electrode.

  In the distal deflection operable catheter of the present invention, one end and the other end of the operation wire are proximal ends, the inside of the catheter tube extends from the one end (proximal end) in the distal direction, and the leaf spring One wire that passes through one side of the leaf spring, is folded at the distal end of the leaf spring, passes through the other side of the leaf spring, extends in the proximal direction, and reaches the other end (proximal end). It is preferable that the distal end portion of the operation wire is caulked and fixed on one surface and the other surface of the distal end portion of the leaf spring.

  According to such a configuration, the direction of the distal end of the catheter is changed in both directions by bending and deforming the leaf spring to the one surface side and the other surface side by one wire having the folded portion as the distal end. Therefore, the number of parts can be reduced, and the manufacture is facilitated.

  In the tip deflection operable catheter of the present invention having such a configuration, it is preferable that a notch or a through hole for guiding the return of the operation wire is formed at the distal end portion of the leaf spring.

  In the tip deflection operable catheter of the present invention, the manipulation wire comprises a wire having one end as a proximal end, extending in the distal direction inside the catheter tube, and the other end as a distal end, The distal end of the manipulation wire may be caulked and fixed on one surface or the other surface of the distal end of the leaf spring.

According to such a configuration, it is possible to change the direction of the distal end of the catheter in one direction by bending and deforming the leaf spring to one surface side or the other surface side by one operation wire.
Further, two such operation wires are prepared, and these distal ends are caulked and fixed to one surface and the other surface of the distal end portion of the leaf spring, respectively, so that the two wires can be used as the leaf spring. Can be deflected and deformed in both directions, one side and the other, to change the orientation of the distal end of the catheter in both directions.

  In the distal deflection operable catheter of the present invention having the above-described configuration, a retaining sleeve is attached to the distal end of the operation wire, and the distal end of the operation wire is attached to the distal end of the operation wire. A large-diameter portion having a diameter larger than the inner diameter of the sleeve is formed, and the proximal end surface of the sleeve is brought into contact with the distal end surface of the ring-shaped member, whereby one or the other surface of the leaf spring is aligned. The sleeve is restricted from moving in the proximal direction, and the large-diameter portion of the distal end of the manipulation wire is brought into contact with the distal end surface of the sleeve, whereby the manipulation wire is moved to the sleeve. It is preferable that the movement in the proximal direction is restricted.

  According to such a configuration, it is possible to reliably prevent the operation wire from moving in the proximal direction along one surface or the other surface of the leaf spring (the operation wire fixed by crimping comes off). .

  In the distal deflection operable catheter of the present invention, the ring-shaped member is preferably made of copper or a copper alloy.

According to the ring-shaped member made of copper or copper alloy, when the distal end portion of the operating wire is caulked and fixed to one surface and / or the other surface of the distal end portion of the leaf spring, the fixing work can be easily performed. Can do.
In addition, copper and copper alloys have good wettability with solder, and by fixing by caulking with a ring-shaped member made of copper or copper alloy, the connection strength between the ring-shaped member and the tip electrode is increased, and the tip It is possible to more reliably prevent the electrode from falling off.

According to the distal deflection operable catheter of the present invention (Claim 1), the distal end portion of the manipulation wire is caulked and fixed to the one surface and / or the other surface of the distal end portion of the leaf spring by the ring-shaped member. Therefore, regardless of the constituent material of the leaf spring and the constituent material of the operation wire, the operation wire can be firmly connected and fixed to the leaf spring. Does not leave.
In addition, according to the catheter of the present invention (Claim 2), the tip tip electrode can be prevented from falling off, and the tip tip electrode is filled when the manipulation wire is pulled. It is possible to reliably prevent the distal end of the operation wire from coming out of the solder that is applied.
Further, the inside of the catheter tube extends from one end (proximal end) in the distal direction, passes through one surface side of the leaf spring, turns back at the distal end portion of the leaf spring, and passes through the other surface side of the leaf spring. , A manipulation wire comprising a single wire extending in the proximal direction to the other end (proximal end), the distal end of the manipulation wire on one side and the other side of the distal end of the leaf spring According to the catheter of the present invention (Claim 3) in which the portion is caulked and fixed, the leaf spring can be bent and deformed in one direction and the other direction by one operation wire. Therefore, the number of parts can be reduced, and the manufacturing efficiency is excellent as compared with the conventional one.

<First Embodiment>
Hereinafter, the present invention will be described based on embodiments shown in the drawings.
FIG. 1 is a front view showing an electrode catheter which is an embodiment of a catheter capable of tip deflection operation according to the present invention,
FIG. 2 is a partially cutaway front view of the distal end side of the catheter shown in FIG.
FIG. 3 is a partially cutaway plan view of the distal end side of the catheter shown in FIG.
4 is a cross-sectional view taken along the line II of FIG.
FIG. 5 (1) is a plan view showing the shape of a leaf spring constituting the catheter shown in FIG.

The electrode catheter 2 according to the present embodiment shown in FIG. 1 is used, for example, for diagnosis or treatment of arrhythmia in the heart.
In FIG. 1, 4 is a catheter tube, 10 is a tip electrode fixed to the distal end of the catheter tube 4, 12 is a ring electrode attached to the distal end of the catheter tube 4, and 6 is a catheter. Connectors (handles) 7 attached to the proximal end of the tube 4 are knobs attached to the connector 6 for performing a deflection movement operation (swinging operation) of the distal end of the catheter tube 4. From the connector 6, lead wires (not shown) that are electrically connected to the tip electrode 10 and the ring electrode 12 are drawn out.

  As shown in FIGS. 2 to 4, the electrode catheter 2 of the present embodiment includes a catheter tube 4, a tip electrode 10 fixed to the distal end of the catheter tube 4, and a distal end portion of the catheter tube 4. A plurality of (two) attached ring-shaped electrodes 12, a leaf spring 20 disposed inside the distal end side (near the distal end) of the catheter tube 4, and the inside of the catheter tube 4 along the axial direction And a ring-shaped member for caulking and fixing the distal end 303 of the operating wire 30 to the one surface 201 and the other surface 202 of the distal end 203 of the leaf spring 20. 40.

  The catheter tube 4 is configured by a hollow tube member. The catheter tube 4 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 having a proximal end portion that is relatively more rigid than the distal end portion.

Examples of the constituent material of the catheter tube 4 include synthetic resins such as polyolefin, polyamide, polyether polyamide, and polyurethane.
The outer diameter of the catheter tube 4 is generally about 0.6 to 3 mm, and the inner diameter is about 0.5 to 2.5 mm. Conductive wires (not shown) connected to the distal tip electrode 10 and the ring electrode 12 are respectively insulated and passed through the axial lumen of the catheter tube 4.

The tip electrode 10 fixed to the distal end of the catheter tube 4 is formed by integrally forming a bullet-shaped tip portion 101 and a cylindrical portion 102 continuous therewith. The catheter tube 4 is inserted into the inner hole from the distal end and fixed by an adhesive.
Examples of the constituent material of the tip electrode 10 include metals having good thermal conductivity such as aluminum, copper, stainless steel, gold, and platinum. Note that the tip electrode 10 is preferably made of platinum or the like in order to provide good contrast for X-rays.
The outer diameter of the distal tip electrode 10 is not particularly limited, but is preferably about the same as the outer diameter of the catheter tube 4 and is usually about 0.6 to 3 mm.

Examples of the constituent material of the ring-shaped electrode 12 attached to the distal end portion of the catheter tube 4 include the same metals as those exemplified as the constituent material of the tip electrode 10. The outer diameter of the ring-shaped electrode 12 is not particularly limited, but is preferably about the same as the outer diameter of the catheter tube 4 and is usually about 0.6 to 3 mm.
Of course, the number of ring-shaped electrodes attached to the distal end of the catheter tube 4 is not limited to two.

The leaf spring 20 disposed inside the distal end side of the catheter tube 4 is a swinging member that can be deformed in the bending direction.
As shown in FIG. 5 (1), the distal end 203 of the leaf spring 20 is formed with a notch 20 C for guiding the return of the operation wire. As shown in FIG. 5 (2), it is also possible to use a leaf spring 20 ′ in which a through hole 20P is formed instead of the notch. The axial length (L) of the leaf spring 20 is not particularly limited, and is 40 to 300 mm, for example. The width (W) of the leaf spring 20 is not particularly limited as long as it fits inside the catheter tube 4.
The material of the leaf spring 20 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.

In the electrode catheter 2 of the present embodiment, caulking is adopted as means for connecting and fixing the operation wire 30 to the leaf spring 20, and solder is not used as in the prior art. Inferior metal materials (for example, stainless steel and Ni—Ti alloy) can be used, and even polymer materials having inferior heat resistance compared to metal materials can be used.
The proximal end of the leaf spring 20 is connected and fixed to the catheter tube 4 or connected to and fixed to the distal end of a coil tube (not shown) that receives the reaction force of the pulling force acting on the operation wire 30.

The operation wire 30 extending in the axial direction inside the catheter tube 4 has a proximal end disposed so as to be capable of being pulled.
One end and the other end of the operation wire 30 are proximal ends, and the inside of the catheter tube 4 extends from one end (proximal end) in the distal direction (upward in FIGS. 2 and 3). 201 passes through the 201 side, is guided by a notch formed in the distal end portion 203 of the leaf spring 20, and is folded back (therefore, the folded portion becomes the distal end of the operation wire 30). It consists of a single wire that runs through the side in the proximal direction (downward) to the other end (proximal end).
One end and the other end, which are proximal ends of the operation wire 30, are connected to a knob 7 for performing a deflection movement operation (swing operation) of the distal end portion of the catheter tube 4.

  The operation wire 30 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. May be. By configuring the operation wire with a non-conductive wire, the cause of high-frequency noise can be reduced.

The ring-shaped member 40 is for fixing the distal end 303 of the operation wire 30 to the one surface 201 and the other surface 202 of the distal end 203 of the leaf spring 20 by caulking.
As a result, the distal end 303 (the portion before and after folding) of the operation wire 30 can be firmly connected and fixed to the one surface 201 and the other surface 202 of the distal end 203 of the leaf spring 20.
Since the caulking is used as the connecting and fixing means of the operation wire 30 to the leaf spring 20 (one surface 201 and the other surface 202) and solder is not used, the operation wire 30 is low in wettability with solder. Can be used.

The constituent material of the ring-shaped member 40 can be appropriately selected from metals that can be easily subjected to caulking (connection and fixing of the operation wire 30 to the leaf spring 20).
Further, as will be described later, the distal end portion 203 of the leaf spring 20 and the distal end portion 303 of the operation wire 30 that are caulked and fixed by the ring-shaped member 40 are filled in the tip electrode electrode 10 (inner recess). In order to connect and fix to the tip electrode 10 with the solder 50 thus formed, the constituent material of the ring-shaped member 40 is preferably a metal material having good wettability to solder. From this viewpoint, copper or a copper alloy can be cited as a suitable constituent material for the ring-shaped member 40. By using copper or a copper alloy as the constituent material of the ring-shaped member 40, the constituent material of the leaf spring 20 and the constituent material of the operation wire 30 have low wettability with solder (for example, stainless steel, Ni-Ti alloy). ), The distal end portions of the leaf spring 20 and the operation wire 30 can be firmly connected and fixed to the tip electrode 10.

As shown in FIGS. 2 to 4, in the electrode catheter 2 of the present embodiment, the distal end portion 203 of the leaf spring 20 and the distal end portion 303 of the operation wire 30 that are caulked and fixed by the ring-shaped member 40 are provided. The tip tip electrode 10 is connected and fixed to the tip tip electrode 10 by solder 50 filled in the tip tip electrode 10.
That is, the distal end portion 203 of the leaf spring 20, the distal end portion 303 of the operation wire 30, and the ring-shaped member 40 are embedded in the solder 50 filled in the tip chip electrode 10.

  The material of the solder 50 filled in the tip electrode 10 is not particularly limited, and examples thereof include Sn—Pb, Sn—Pb—Ag, and Sn—Pb—Cu, and Pb Free solder such as Sn-Ag-Cu, Sn-Cu, Sn-Ag, and Sn-Ag-Cu-Bi can also be used.

  In the electrode catheter 2 of the present embodiment, by operating the knob 7 of the connector 6, either one end or the other end of the operation wire 30 is pulled in the proximal direction, and the leaf spring 20 is bent, whereby the electrode The distal end of the catheter 2 can be swung in the direction indicated by the arrow A or B.

For example, when the knob 7 shown in FIG. 1 is turned counterclockwise, one end of the operation wire 30 is pulled in the proximal direction, and the leaf spring 20 is bent toward the one surface 201 side. The leading end is swung in the direction indicated by arrow A. Further, when the knob 7 is turned clockwise, the other end of the operation wire 30 is pulled in the proximal direction, and the leaf spring 20 is bent toward the other surface 202 side, whereby the distal end of the electrode catheter 2 is moved. The head is deflected in the direction indicated by the arrow B. Thus, the number of components can be reduced because the single spring 30 can bend and deform the leaf spring 20 in both directions of the one surface 201 (arrow A direction) and the other surface 202 (arrow B direction). (2 wires are conventionally required to be 1), and the manufacture is facilitated.
If the connector 6 is rotated about the axis, the direction in the A or B direction with respect to the electrode catheter 2 can be freely set while being inserted into the body cavity.

  According to the electrode catheter 2 of the present embodiment, the distal end portion 303 (the portion before and after folding) of the operation wire 30 with respect to each surface of the one surface 201 and the other surface 202 of the distal end portion 203 of the leaf spring 20. Is fixed by caulking with the ring-shaped member 40, the operation wire 30 can be firmly connected and fixed to the leaf spring 20 regardless of the material of the leaf spring 20 and the material of the operation wire 30. The operation wire 30 is not detached from the one surface 201 or the other surface 202 of the leaf spring 20 during use of the catheter (in the procedure).

  Further, according to the electrode catheter 2 of the present embodiment, the distal end 203 of the leaf spring 20, the distal end 303 of the operation wire 30, and the ring-shaped member 40 for caulking and fixing them are the tip. In contact with the solder 50 filled in the inside of the electrode 10 (implanted), the tip electrode 10 is in addition to the distal end of the catheter tube 4 and the distal end 203 of the leaf spring 20, The solder 50 is fixedly connected (fixed) to the distal end 303 of the operation wire 30 that is caulked and fixed to the distal end of the leaf spring 20 and the ring-shaped member 40 is embedded. The leaf spring 20 and the operation wire 30 are pulled out of the solder 50 by the increase in the contact area with the metal and the effect of improving the wettability of the ring-shaped member 40 made of copper or copper alloy with respect to the solder 50 Drag (fixing strength of the distal tip electrode 10) is increased. Thereby, it is possible to reliably prevent the distal tip electrode 10 from falling off the catheter tube 4.

  Further, the distal end 303 of the operation wire 30 is caulked and fixed to the one surface 201 and the other surface 202 of the distal end 203 of the leaf spring 20 by the ring-shaped member 40 (the distal end of the leaf spring 20). 203, the distal end portion 303 of the operation wire 30 and the ring-shaped member 40 are in contact with the solder 50), so that the force to pull out the operation wire 30 from the solder 50 can be reduced. Thus, the distal end portion 203 of the leaf spring 20 and the ring-shaped member 40 act as a retaining (pull-out resistance). Thereby, when the operation wire 30 is pulled, it is possible to reliably prevent the distal end of the operation wire 30 from coming out of the solder 50 filled in the tip electrode 10. .

<Second Embodiment>
6 and 7 are a partially broken front view and a partially broken plan view of the distal end side of an electrode catheter according to another embodiment of the present invention.
In addition, the same code | symbol is used for the component which is the same as that of 1st Embodiment, or respond | corresponds.

  The external shape of the electrode catheter of this embodiment is the same as that of the first embodiment shown in FIG. As shown in FIGS. 6 and 7, the electrode catheter of the present embodiment is attached to the catheter tube 4, the tip electrode 10 fixed to the distal end of the catheter tube 4, and the distal end of the catheter tube 4. A plurality of (two) ring-shaped electrodes 12, a leaf spring 25 disposed inside the distal end side (near the distal end) of the catheter tube 4, and the inside of the catheter tube 4 along the axial direction The operation wire 35 arranged to extend, the ring-shaped member 40 for caulking and fixing the distal end portion of the operation wire 35 to the surface 252 at the distal end portion of the leaf spring 25, and the operation wire 35 And a retaining sleeve 60 attached to the distal end of the sleeve.

  The leaf spring 25 constituting the electrode catheter of the present embodiment has the same configuration as that of the leaf spring 20 constituting the first embodiment except that the notch is not formed at the distal end portion.

One end of the operation wire 35 constituting the electrode catheter of this embodiment is a proximal end, and the inside of the catheter tube 4 (the surface 252 side of the leaf spring 25) is in the distal direction (upward in FIGS. 6 and 7). The other end is a wire that extends to the distal end.
The proximal end of the operation wire 35 is arranged so that it can be pulled. That is, the proximal end of the operation wire 35 is connected to a knob (knob 7 shown in FIG. 1) for performing a deflection movement operation of the distal end portion of the catheter tube 4.

  A distal end of the operation wire 35 is formed with a retaining large-diameter portion (a retaining portion) 35a. As a method of forming the retaining portion 35a, for example, a method of forming by TIG welding can be exemplified.

The distal end portion of the operation wire 35 is caulked and fixed to the surface 252 of the distal end portion of the leaf spring 25 by the ring-shaped member 40.
Thereby, by operating the knob of the connector and pulling the operation wire 35, the leaf spring 25 is bent toward the surface 252 side, and the distal end of the electrode catheter is deflected in one direction (direction indicated by arrow B). It is possible.

The retaining sleeve 60 constituting the electrode catheter of the present embodiment is attached (extrapolated) to the distal end portion of the operation wire 35 (distal end side from the fixing position by the ring-shaped member 40).
The outer diameter of the sleeve 60 is set such that the sleeve 60 is not inserted into the space surrounded by the inner peripheral surface of the ring-shaped member 40 and the surface 252 of the leaf spring 25. Thereby, since the proximal end surface of the sleeve 60 is contact | abutted with the distal end surface of the ring-shaped member 40, it is controlled that the sleeve 60 moves to a proximal direction.
The inner diameter of the sleeve 60 is slightly larger than the outer diameter of the operation wire 35, but is smaller than the diameter of the retaining portion 35 of the operation wire 35. Thereby, the retaining portion 35a of the operation wire 35 is brought into contact with the distal end surface of the sleeve 60, and the operation wire 35 is restricted from moving in the proximal direction inside the sleeve 60.
By attaching such a sleeve 60 to the distal end portion of the operation wire 35, when the operation wire 35 is pulled, the operation wire 35 moves in the proximal direction in the catheter tube 4 ( It is possible to reliably prevent the caulking-fixed operation wire 35 from being detached from the ring-shaped member 40 and coming off.

  The constituent material of the sleeve 60 is not particularly limited, and for example, stainless steel can be used. However, it is preferable to use a metal material (for example, phosphor bronze) having good wettability with the solder 50.

As shown in FIGS. 6 and 7, in the electrode catheter of this embodiment, the distal end of the leaf spring 25 and the distal end of the operation wire 35 fixed by caulking with the ring-shaped member 40 are the tip. It is connected and fixed to the tip electrode 10 by solder 50 filled in the electrode 10.
That is, the distal end portion of the leaf spring 25, the distal end portion of the operation wire 35, the ring-shaped member 40, and the sleeve 60 are embedded in the solder 50 filled in the tip electrode 10. Yes.

In the electrode catheter of the present embodiment, by operating the knob of the connector, one end (proximal end) of the operation wire 35 is pulled in the proximal direction and the leaf spring 25 is bent, thereby the distal end of the electrode catheter The end can be swung in one direction.
For example, by rotating the knob 7 shown in FIG. 1 in the clockwise direction, one end (proximal end) of the operation wire 35 is pulled in the proximal direction, and the leaf spring 25 is bent toward the surface 252 side. The distal end of the catheter is swung in the direction indicated by arrow B.

  According to the electrode catheter of the present embodiment, the distal end portion of the operation wire 35 is caulked and fixed to the surface 252 at the distal end portion of the leaf spring 25 by the ring-shaped member 40. Regardless of the constituent material and the constituent material of the operation wire 35, the operation wire 35 can be firmly connected and fixed to the leaf spring 25, and the surface of the leaf spring 25 can be used while the catheter is being used (in the procedure). The operating wire 35 is not detached from 252.

  Further, according to the electrode catheter of the present embodiment, the distal end portion of the leaf spring 25, the distal end portion of the operation wire 35, the ring-shaped member 40 for caulking and fixing them, and the far end of the operation wire 35 are provided. The sleeve 60 attached to the distal end portion contacts (embeds) the solder 50 filled in the tip tip electrode 10, and the tip tip electrode 10 is connected to the distal end of the catheter tube 4 and the leaf spring 25. In addition to two locations with the distal end portion of the leaf spring 25, it is also connected and fixed (fixed) to the distal end portion of the operation wire 35 that is caulked and fixed to the distal end portion of the leaf spring 25, and the ring Increase in contact area with the solder 50 due to the embedded member 40 and sleeve 60 being embedded, and wetting of the solder 50 due to the ring member 40 being made of copper or a copper alloy and the sleeve 60 being made of phosphor bronze. The effect of improving, pull-out resistance force against the solder 50 of the leaf spring 25 and the operating wire 35 (adhesive force of the distal tip electrode 10) is increased. Thereby, it is possible to reliably prevent the distal tip electrode 10 from dropping from the catheter tube 4.

  Further, the distal end portion of the operation wire 35 is caulked and fixed to the surface 252 at the distal end portion of the leaf spring 25 by the ring-shaped member 40 (the distal end portion of the leaf spring 20 and the operation wire 35). The distal end portion of the coil, the ring-shaped member 40, and the sleeve 60 are in contact with the solder 50), so that the leaf spring against the force for pulling the operation wire 35 out of the solder 50 The distal end portion of 25, the ring-shaped member 40 and the sleeve 60 act as a stopper (pull-out resistance). Thereby, when the operation wire 35 is pulled, it is possible to reliably prevent the distal end of the operation wire 35 from coming out of the solder 50 filled in the tip electrode 10. .

<Third Embodiment>
8 and 9 are a partially broken front view and a partially broken plan view of the distal end side of an electrode catheter according to another embodiment of the present invention.
In addition, the same code | symbol is used for the component which is the same as that of 2nd Embodiment, or respond | corresponds.

  The external shape of the electrode catheter of this embodiment is the same as that of the first embodiment shown in FIG. As shown in FIGS. 8 and 9, the electrode catheter of this embodiment has the same configuration as that of the second embodiment, and further extends to the surface 251 side of the leaf spring 25 inside the catheter tube 4. And an anti-removal sleeve 61 attached to the distal end of the operation wire 36.

  One end of the operation wire 36 constituting the electrode catheter of the present embodiment is a proximal end, and the inside of the catheter tube 4 is distal (upward in FIGS. 8 and 9) on the surface 251 side of the leaf spring 25. It is a wire that extends and has the other end as a distal end, and has the same configuration as the operation wire 35 that extends toward the surface 252 of the leaf spring 25, and a retaining portion is also provided at the distal end of the operation wire 36. 36a is formed.

The proximal end of the operation wire 36 is arranged so that it can be pulled. That is, the proximal end of the operation wire 36 is connected to a knob (knob 7 shown in FIG. 1) for performing a deflection movement operation of the distal end portion of the catheter tube 4.
The distal end portion of the operation wire 36 is caulked and fixed to the surface 251 of the distal end portion of the leaf spring 25 by the ring-shaped member 40.

The sleeve 61 constituting the electrode catheter of this embodiment is attached (extrapolated) to the distal end portion of the operation wire 36.
The sleeve 61 has the same configuration as the sleeve 60 attached to the distal end portion of the operation wire 35, and the sleeve 61 is brought into contact with the distal end surface of the ring-shaped member 40 by contacting the proximal end surface of the sleeve 61. The movement of 61 in the proximal direction is restricted. Further, when the retaining portion 36 a of the operation wire 36 is brought into contact with the distal end surface of the sleeve 61, the movement of the operation wire 36 in the proximal direction in the sleeve 61 is restricted.
By attaching such a sleeve 61 to the distal end portion of the operation wire 36, when the operation wire 36 is pulled, the operation wire 36 moves proximally in the catheter tube 4 ( It is possible to reliably prevent the caulking-fixed operation wire 36 from being detached from the ring-shaped member 40).

  As shown in FIGS. 8 and 9, in the electrode catheter of this embodiment, the distal end of the leaf spring 25, the distal end of the operation wire 35 and the sleeve 60 attached thereto, and the operation wire The distal end portion of 36, the sleeve 61 attached thereto, and the ring-shaped member 40 are embedded in the solder 50 filled in the tip electrode 10.

In the electrode catheter of this embodiment, the distal end of the catheter can be swung in the direction of arrow A or B by operating the knob of the connector.
For example, by rotating the knob 7 shown in FIG. 1 counterclockwise, one end (proximal end) of the operation wire 36 is pulled in the proximal direction, and the leaf spring 25 is bent toward the surface 251 side. The distal end of the electrode catheter is swung and deflected in the direction indicated by arrow A. Further, by rotating the knob 7 clockwise, one end (proximal end) of the operation wire 35 is pulled in the proximal direction, and the leaf spring 25 is bent toward the surface 252 side, so that the distal end of the electrode catheter The end can be swung and deflected in the direction indicated by arrow B.

  According to the electrode catheter of the present embodiment, the distal end of the operation wire 35 is caulked and fixed to the surface 252 at the distal end of the leaf spring 25 by the ring-shaped member 40, and the distal end of the leaf spring 25 is fixed. Since the distal end portion of the operation wire 36 is caulked and fixed to the surface 251 at the end portion, regardless of the constituent material of the leaf spring 25 and the constituent materials of the operation wires 35 and 36, The operation wires 35 and 36 can be firmly connected and fixed, and the operation wires 36 and 35 are detached from the surfaces 251 and 252 of the leaf spring 25 during the use of the catheter (in the procedure). Absent.

  Further, according to the electrode catheter of the present embodiment, the distal end portion of the leaf spring 25, the operation wire 35, the sleeve 60, the operation wire 36, the sleeve 61, and the ring-shaped member 40 are arranged at the tip. The tip electrode 10 is in contact with (embedded with) the solder 50 filled inside the tip electrode 10, and the tip electrode 10 is added to the distal end of the catheter tube 4 and the distal end of the leaf spring 25. The operation wire 35 that is caulked and fixed to the distal end portion of the leaf spring 25 and the distal end portion of the operation wire 36 are also connected and fixed (fixed), and the ring-shaped member 40, the sleeve 60, and the sleeve The contact area with the solder 50 is increased due to the embedded 61, the ring-shaped member 40 is made of copper or a copper alloy, and the sleeve 60 and the sleeve 61 are made of phosphor bronze. The effect of improving the wettability to da 50, the leaf spring 25, operating wire 35, pull-out resistance force against the solder 50 of the operating wire 36 (adhesive force of the distal tip electrode 10) is increased. Thereby, it is possible to reliably prevent the distal tip electrode 10 from dropping from the catheter tube 4.

  Further, the distal ends of the operation wires 35 and 36 are caulked and fixed to the surfaces 252 and 251 at the distal end of the leaf spring 25 by the ring-shaped member 40 (the distal end of the leaf spring 20 and The distal end of the operation wire 35, the sleeve 60, the distal end of the operation wire 36, the sleeve 61, and the ring-shaped member 40 are in contact with the solder 50). The distal end of the leaf spring 25, the ring-shaped member 40, and the sleeve 60 or 61 act as a retaining (extraction resistance) against the force for extracting the operation wire 35 or the operation wire 36 from the solder 50. To do. Accordingly, when the operation wire 35 or the operation wire 36 is pulled, the distal end of the operation wire 35 or the operation wire 36 is pulled out from the solder 50 filled in the tip electrode 10. Can be reliably prevented.

<Modification>
As mentioned above, although embodiment of this invention was described, this invention is not limited to these, A various change is possible.
For example, the distal end of the leaf spring and the distal end of the operation wire that are caulked and fixed by a ring-shaped member may be connected and fixed to the tip electrode by means other than solder.
In addition, a mode in which the distal end portion of the leaf spring and the distal end portion of the operation wire that are caulked and fixed by the ring-shaped member are not connected and fixed to the tip electrode is included in the scope of the present invention.

It is a front view which shows the electrode catheter which is one Embodiment of this invention. It is a partially broken front view of the distal end side of the electrode catheter shown in FIG. It is a partially broken top view of the distal end side of the electrode catheter shown in FIG. It is II sectional drawing of FIG. It is a top view which shows the shape of a leaf | plate spring. It is a partially broken front view of the distal end side of the electrode catheter which is other embodiment of this invention. It is a partially broken top view of the distal end side of the electrode catheter which is other embodiment of this invention. It is a partially broken front view of the distal end side of the electrode catheter which is other embodiment of this invention. It is a partially broken top view of the distal end side of the electrode catheter which is other embodiment of this invention. It is sectional drawing which shows the inside of the distal end side of the conventional electrode catheter.

Explanation of symbols

2 electrode catheter 4 catheter tube 6 connector 7 knob 10 tip electrode 101 tip portion 102 cylindrical portion 12 ring electrode 20 leaf spring 201 one surface 202 other surface 203 distal end of leaf spring 25 leaf spring 251 surface 252 surface 30 operation Wire 303 distal end portion of operation wire 35, 36 operation wire 40 ring-shaped member 50 solder 60, 61 sleeve for retaining

Claims (8)

A catheter tube;
A tip electrode fixed to the distal end of the catheter tube;
A leaf spring for swinging that is arranged along the axial direction inside the distal end side of the catheter tube and is deformable in the bending direction;
An operation wire that is arranged so as to extend along the axial direction inside the catheter tube, and whose proximal end is capable of pulling operation;
A ring-shaped member for caulking and fixing the distal end portion of the manipulation wire to one surface and / or the other surface of the distal end portion of the leaf spring;
A catheter capable of tip deflection operation.   The distal end of the leaf spring and the operation wire fixed by caulking by the ring-shaped member is connected and fixed to the tip electrode by solder filled in the tip tip electrode. The catheter according to claim 1, characterized in that the tip deflection operation is possible.   The manipulation wire has a proximal end at one end and the other end, extends in the distal direction from the one end to the inside of the catheter tube, passes through one surface side of the leaf spring, and is a distal end portion of the leaf spring. And is formed of a single wire extending in the proximal direction to the other end through the other surface side of the leaf spring, and the operation is performed on one surface and the other surface of the distal end portion of the leaf spring. The distal end deflectable catheter according to claim 1 or 2, wherein a distal end portion of the wire is fixed by caulking.   4. The tip deflectable manipulatable catheter according to claim 3, wherein a notch for guiding folding of the operation wire is formed at a distal end portion of the leaf spring.   The distal end deflectable maneuverable catheter according to claim 3, wherein a distal hole of the leaf spring is formed with a through hole that guides the folding of the manipulation wire.   The manipulation wire comprises a wire having one end serving as a proximal end, extending in the distal direction inside the catheter tube, and the other end serving as a distal end, and one surface of the distal end of the leaf spring or 3. The tip deflection operable catheter according to claim 1, wherein a distal end portion of the operation wire is fixed by caulking on the other surface. The distal end portion of the operation wire is attached with a sleeve for retaining, and the distal end of the operation wire is formed with a large diameter portion larger in diameter than the inner diameter of the sleeve,
When the proximal end surface of the sleeve is brought into contact with the distal end surface of the ring-shaped member, the sleeve is restricted from moving in the proximal direction along one surface or the other surface of the leaf spring, The large-diameter portion of the distal end of the operation wire is brought into contact with the distal end surface of the sleeve, so that the operation wire is restricted from moving in the proximal direction inside the sleeve. The catheter capable of operating a tip deflection according to claim 6.   The tip-deflable catheter according to any one of claims 1 to 7, wherein the ring-shaped member is made of copper or a copper alloy.

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